WO2025184141A1

WO2025184141A1 - Patient access system

Info

Publication number: WO2025184141A1
Application number: PCT/US2025/017293
Authority: WO
Inventors: Karen CRONHOLM; Joshua MATTE; Oivind Brockmeier; Robert THURMAN; R. Maxwell Flaherty; J. Christopher Flaherty
Original assignee: Akeyna Inc
Current assignee: Akeyna Inc
Priority date: 2024-02-26
Filing date: 2025-02-26
Publication date: 2025-09-04
Anticipated expiration: 2026-08-26

Abstract

Systems, devices, and methods for accessing a target location within a patient are provided herein. A system includes an access device, a sensor assembly, and a processing assembly. The access device includes an access element with a port and provides access to the target location. The sensor assembly produces a signal related to tissue and/or other material proximate the target location. The processing assembly is operably connected to the sensor assembly. The processing assembly processes the signal from the sensor assembly to further perform a function. The function can include detecting the target location and/or detecting a non-target location.

Description

PATIENT ACCESS SYSTEM

RELATED APPLICATIONS

[001] This application claims the benefit of United States Provisional Patent Application Serial Number 63/557,691 and titled "Fluid Delivery System", filed February 26, 2024, the content of which is incorporated herein by reference in its entirety for all purposes.

FIELD OF THE INVENTIVE CONCEPTS

[002] The present inventive concepts relate generally to systems, devices, and methods for accessing a target location within a patient, for example to safely deliver one or more agents.

BACKGROUND

[003] Delivery of agents into a patient can be associated with various complications, such as complications associated with delivery of the agent to a non-intended location. Systems, devices, and methods for safely accessing target locations within a patient are desired.

SUMMARY

[004] According to an aspect of the present inventive concepts, a system for accessing a target location within a patient comprises an access device comprising an access element comprising a distal portion and configured to provide access to the target location. The system further comprises a sensor assembly configured to produce a signal related to tissue and/or other material proximate the target location. The system further comprises a processing assembly operably connected to the sensor assembly and configured to process the signal from the sensor assembly and perform a function selected from the group consisting of detect and/or confirm the target location (e.g., detect and/or confirm by identifying a target tissue type); detect and/or confirm one or more non-target locations (e.g., detect and/or confirm by identifying one or more non-target tissue types); or detect and/or confirm the target location (e.g., detect and/or confirm by identifying a target tissue type) and detect one or more non-target locations (detect and/or confirm by identifying one or more non-target tissue types). [005] In some embodiments, the system further comprises an agent, and the system is configured to perform one, two, or more medical procedures selected from the group consisting of: collecting tissue and/or collecting other material from a location within the patient; delivering an agent to a location within the patient; implanting a device within the patient; positioning an introducer device into the patient; performing a therapeutic and/or diagnostic medical procedure where the access device provides access to a target location; and combinations thereof. The target location can comprise one, two, or more locations within the patient selected from the group consisting of: a cosmetic target location; an artery; a vein; a duct; a conduit of the spine such as the epidural space and/or the intrathecal space; a bone such as a location within a bone; an organ such as the brain, the heart, the liver, the pancreas, the stomach, the bladder; the small intestine; the large intestine; a kidney, a lung, a breast, and/or other organ; a gland; and combinations thereof. The target location can comprise target tissue selected from the group consisting of: tissue to be treated to improve patient cosmesis; blood; tumor tissue; abnormal tissue; tissue to be biopsied; dermal tissue; epidermal tissue; tissue of an organ; scar tissue; and combinations thereof.

[006] In some embodiments, the system is configured to avoid: undesirably delivering an agent into a blood vessel; undesirably damaging a nerve; and/or undesirably damaging an organ.

[007] In some embodiments, the system further comprises an agent, and the system is configured to deliver the agent to the target location via the access element. The processing assembly can be further configured to detect an undesired event caused by the delivery of the agent to the target location. The undesired event can comprise compression of a blood vessel. The blood vessel can comprise a blood vessel of an eye or other blood vessel. The undesired event can comprise detection of the agent in a blood vessel. The blood vessel can comprise a blood vessel of an eye or other blood vessel. The undesired event can comprise damage to a nerve. The agent can comprise one, two, or more agents selected from the group consisting of: a cosmetic agent; a pharmaceutical agent; a biologic agent; a chemotherapeutic agent; an anticoagulant; an analgesic; a radioisotope, such as a liquid radioisotope; an antibiotic, such as vancomycin, meropenem, and/or gentamicin; an antifungal agent, such as micafungin and/or amphotericin; a pain relief medication, such as hydromorphone and/or morphine; an antiparasitic, such as albendazole; an agent for treating low blood pressure, such as dopamine, epinephrine, norepinephrine, and/or dobutamine; an intravenous immunoglobulin medication (IVIG); a hormonal agent, such as estrogen; a steroid, such as methyl prednisone; an enzyme, such as lipase; a protein; a peptide, such as protein C concentrate; a monoclonal antibody, such as IgG; an amino acid, such as lysine; blood; plasma and/or other blood component; cells; and combinations thereof. The agent can comprise a cosmesis improvement agent. The agent can comprise a cosmesis improvement agent selected from the group consisting of: cosmesis improvement agent; filler; a dermal filler; hyaluronic acid; fat such as autologous fat; calcium hydroxyapatite; poly-l-lactic acid; polyalkylimide; polymethyl-methacrylate microspheres (PMMA); a neurotoxin; a plastic; platelet rich plasma (PRP); collagen, silicone; vitamins (such as vitamin C) or products derived from vitamins (such as retinoids or niacinamide); oils or lipids (such as ceramides); proteins (such as elastin) or amino acids (such as betaine); enzymes (such as lipase or hyaluronidase); organic acids (such as alpha hydroxy acids, glycolic acid or lactic acid); botanicals or plant extracts (such as aloe vera or caffeine); water and/or ice slurry; and combinations thereof. The target location can comprise tissue outside of a blood vessel to which a cosmesis improvement procedure is being performed. The target location can comprise tissue proximate an eye of the patient. The target location can comprise a location selected from the group consisting of: the forehead; the temples; the zygoma; the anterior cheek; the lateral cheek; the medial cheek; the tear trough; the scalp; the nose; the lips; the chin; the side of the chin; Marionette lines; the nasolabial fold; the sub zygoma; the jawline; the palpebromalar groove; the jowls; the neck; platysma bands; the arms; the buttocks; the upper lip; the lower lip; the hands; the chest; the breasts; the legs; the knees; the feet; areas around the eyes; eyebrows; glabella; ears; a supraperiosteal location; scar tissue; the vaginal area; and combinations thereof. The target location can comprise tissue selected from the group consisting of: dermal tissue; epidermal tissue; hypodermal tissue; subcutaneous tissue; tissue at the dermal subcutaneous junction; muscle; fat; and combinations thereof. The agent can comprise a treatment agent. The target location can comprise a blood vessel, and the treatment agent can be delivered systemically via the access element. The treatment agent can comprise an agent selected from the group consisting of: a pharmaceutical agent; a chemotherapeutic agent; an antibiotic; an anticoagulant; an analgesic; a radioisotope; and combinations thereof. The treatment agent can comprise a chemotherapeutic, a liquid radioisotope, or both. The target location can comprise tumor tissue. The treatment agent can comprise a sclerotherapy agent. The target location can comprise a vein of the patient. The agent can comprise a material selected from the group consisting of: blood; plasma or other blood component; cells; and combinations thereof. The agent can comprise an agent storage device. The access device can further comprise a reservoir for storing the agent, and the agent storage device can be configured to transfer the agent from the agent storage device into the reservoir. The processing assembly can be configured to detect the one or more nontarget locations, and the system can be configured to avoid delivery of the agent into the one or more non-target locations. The one or more non-target locations can comprise a blood vessel. The agent can comprise an additive. The additive can be configured to reduce pain and/or to reduce bleeding. The additive can comprise epinephrine and/or an analgesic such as lidocaine. The agent can include beads configured to reduce migration of the agent.

[008] In some embodiments, the system is configured to remove a body substance from the target location via the access element. The body substance can comprise blood. The body substance can comprise a substance selected from the group consisting of: blood; fat; connective tissue; muscle; lymphatic fluid; dermal tissue; tumor tissue, such as tumor tissue from the skin or other parts of the body; marrow; and combinations of thereof. The processing assembly can be configured to detect the one or more non-target locations and the system can be configured to avoid removal of a body substance from the one or more non- target locations.

[009] In some embodiments, the access device comprises at least a portion of the processing assembly.

[010] In some embodiments, the system further comprises a console that operably attaches to the access device, and the console comprises at least a portion of the processing assembly.

[011] In some embodiments, the processing assembly is configured to detect the target location. The target location can comprise a location outside of a blood vessel. The processing assembly can be further configured to detect the one or more non-target locations, and the one or more non-target locations can comprise a blood vessel location and/or a nerve location. The target location can comprise a blood vessel lumen. The system can further comprise an agent to be delivered to the blood vessel lumen via the access element. The agent can comprise a medication. The access element can be configured to remove blood, deliver blood, or both. The target location can comprise epidural space and/or intrathecal space. The system can further comprise an agent comprising an analgesic, and the system can be configured to deliver the analgesic to the epidural space and/or intrathecal space via the access element. The target location can comprise tumor tissue. The system can further comprise an agent comprising: a chemotherapeutic; a liquid radioisotope; or both, and the system can be configured to deliver the agent to the tumor tissue via the access element. The processing assembly can be further configured to detect the one or more non-target locations. The target location can comprise a location outside of a blood vessel, and the one or more non-target locations can comprise a blood vessel location.

[012] In some embodiments, the processing assembly is configured to detect the one or more non-target locations. The one or more non-target locations can comprise a blood vessel location. The system can further comprise an agent comprising a cosmesis improvement agent or other agent, and the system can be configured to deliver the agent to tissue outside of a blood vessel. The target location can comprise tissue proximate an eye of the patient. The one or more non-target locations can comprise a location outside of a blood vessel. The processing assembly can be further configured to detect the target location. The one or more non-target locations can comprise a blood vessel location and the target location can comprise a location outside of a blood vessel. The one or more non-target locations can comprise one or more nerves, and the target location can comprise a location within 20mm or 10mm of the one or more nerves.

[013] In some embodiments, the processing assembly is further configured to detect inflammation of tissue, such as blood vessel tissue and/or other tissue. The processing assembly can detect the inflammation based on increased blood flow. The processing assembly can detect the inflammation based on redness of the tissue. The processing assembly can detect the inflammation based on spectral properties of the tissue. The tissue can comprise the tissue of a blood vessel.

[014] In some embodiments, the access device is configured to provide access to the target location via the access element. The access provided by the access device can comprise fluid access of the target location.

[015] In some embodiments, the access device is configured to, via the access element: deliver a material to the target location; remove a body substance from the target location; or both.

[016] In some embodiments, the access device comprises a reservoir for storing a material. The system can comprise multiple reservoirs. The reservoir can comprise a fillable and/or refillable reservoir.

[017] In some embodiments, the access device further comprises an alert assembly, and the access device is configured to activate the alert assembly when the port of the access element is within a pre-determined distance of the target location and/or the one or more non- target locations. The alert assembly can be configured to modulate, change in tone or volume, or otherwise modify a provided alert as the proximity to the target location and/or non-target location changes. The one or more non-target locations can comprise a blood vessel.

[018] In some embodiments, the access device is configured to be calibrated.

[019] In some embodiments, the access element is coupled to a syringe barrel containing an agent, and the syringe barrel has a plunger disposed therein, and movement of the plunger into the barrel forces the agent through a distal tip of the access element and into an internal location within the patient.

[020] In some embodiments, the access element is coupled to a syringe barrel with a plunger disposed therein, and the plunger is withdrawn to draw fluid from the patient through the access element.

[021] In some embodiments, the access element is configured to penetrate the patient’s skin.

[022] In some embodiments, the access element is configured to provide access to the target location for a time period of at least 1 hour. The access element can be configured to provide access to the target location for a time period of at least 3 days. The access element can be configured to provide access to the target location for a time period of at least 1 week. The access element can be configured to provide access to the target location for a time period of at least 1 month.

[023] In some embodiments, the access element comprises a needle or other filament with a size of at least 32 gauge, a size of no more than 6 gauge, or both. The access element can comprise a needle or other filament of 27 gauge. The access element can comprise a needle or other filament with a size of at least 30 gauge, a size of no more than 23 gauge, or both.

[024] In some embodiments, the access element comprises multiple access elements. A first access element and a second access element can comprise different properties. The different properties can comprise: different diameters; different lengths; different materials of construction; and/or different levels of rigidity.

[025] In some embodiments, the access element comprises a needle.

[026] In some embodiments, the access element comprises a cannula. The access element can further comprise a needle positioned within the cannula.

[027] In some embodiments, the access element comprises a trocar. [028] In some embodiments, the access element comprises a laparoscopic port.

[029] In some embodiments, the access element comprises an introducer.

[030] In some embodiments, the access element comprises a glass filament. The glass filament can comprise a glass needle.

[031] In some embodiments, the access element comprises a filament with two or more lumens. The two or more lumens can comprise staggered distal ends.

[032] In some embodiments, the access element comprises a hub. The hub can comprise a diameter of no more than 30mm, 25mm, and/or 20mm.

[033] In some embodiments, the access element comprises a coating. The coating can comprise a coating selected from the group consisting of a lubricious coating; a hydrophilic coating; a hydrophobic coating; an ultrasonically reflective coating; a radiopaque coating; a conductive coating, such as an electrically and/or thermally conductive coating; a magnetic coating; and combinations thereof.

[034] In some embodiments, the access device comprises at least a portion of the sensor assembly. The access device can comprise all of the sensor assembly.

[035] In some embodiments, the system further comprises a console, and the console comprises at least a portion of the sensor assembly.

[036] In some embodiments, the sensor assembly is configured to determine if the target location and/or the one or more non-target locations are in the advancement pathway of the access element.

[037] In some embodiments, the sensor assembly comprises: a light source configured to deliver light to tissue within the patient to generate reflected light; and a detector configured to detect the reflected light. The light source can comprise a static light source, a modulated light source, or both. The light source can comprise a modulated light source configured to reduce power consumption of the access device. The detector can comprise a photodiode detector. The detector can comprise an optical fiber, such as an optical fiber of at least 10 microns, an optical fiber of no more than 200 microns, and/or a 100 micron fiber. The access device can further comprise a hub and a flange, and the access element, the light source, and the detector can be associated with the hub, and the processing assembly can be associated with the flange. The hub can be detachably connected to the flange. The access device can further comprise a hub and a flange, and the access element can be associated with the hub, and the light source, the detector, and the processing assembly can be associated with the flange. The hub can be detachably connected to the flange. The light source can have a wavelength of at least 568nm, a wavelength of no more than 577nm, or both. The processing assembly can be configured to: determine an intensity level of the reflected light from tissue within the patient; and identify the tissue type associated with the reflected light based on determining the intensity level of the reflected light from the tissue. The processing assembly, when determining an intensity level of the reflected light from the tissue, can be further configured to: compare the intensity level of the reflected light to a reference value, and identify the tissue type associated with the reflected light based on comparing the intensity level of the reflected light to the reference value. The system can further comprise a detector waveguide associated with the access element and optically connected to the detector, and the waveguide can be configured to transmit the reflected light to the detector. The access element can comprise a longitudinal groove, and the detector waveguide can be disposed within the longitudinal groove. The access element can comprise a longitudinal channel within the access element, and the detector waveguide can be disposed within the longitudinal channel. The detector waveguide can comprise an optical fiber. The system can further comprise a source waveguide associated with the access element and optically connected to the light source, and the source waveguide can be configured to transmit light from the light source. The access element can comprise a longitudinal groove, and the source waveguide can be disposed within the longitudinal groove. The access element can comprise a longitudinal channel within the access element, and the source waveguide can be disposed within the longitudinal channel. The detector waveguide can be adjacent to the source waveguide. The detector waveguide can be a first detector waveguide and the detector can be a first detector, the access device further comprising: a second detector waveguide associated with the access element and optically coupled to a second detector, and the second detector waveguide can be configured to transmit the reflected light to the second detector, and the second detector waveguide can be closer to the source waveguide than the first detector waveguide. The source waveguide can comprise an optical fiber. The processing assembly can be configured to perform an analysis of optical absorption based on the signal produced by the sensor assembly. The light source can be configured to produce light with a wavelength between 568nm and 577nm. The light source can be configured to produce light with a wavelength of 13 lOnm. The light source can be configured to produce light with a wavelength between lOOnm and 1800nm. The light source can be configured to produce light at two or more wavelengths. A first wavelength can be selected to detect blood. A second wavelength can be selected to detect a non-blood form of tissue. A second wavelength can be configured to confirm the light source is transmitting light and/or to confirm that the detector is receiving reflected light. The two or more wavelengths of light can be delivered simultaneously. The two or more wavelengths of light can be delivered sequentially. The light source can be configured to adjust the wavelength of light delivered. The light source can be configured to adjust the wavelength based on a known and/or determined location of the access element. The sensor assembly can comprise a first sensor assembly and a second sensor assembly. The first sensor assembly can deliver light to produce a first signal based on the reflected light, and the second sensor assembly can deliver another form of energy to produce a second signal. The another form of energy can comprise ultrasound energy, electromagnetic energy, or both. The second sensor assembly can comprise a blood pressure sensor and/or a respiration sensor. The sensor assembly can comprise at least one optical fiber. The at least one optical fiber can comprise a multimodal optical fiber. The at least one optical fiber can comprise a cladding. The at least one optical fiber can comprise a coating. The at least one optical fiber can comprise a single optical fiber. The at least one optical fiber can comprise a first optical fiber configured to transmit light received from the light source and a second optical fiber configured to transmit the reflected light to the detector. The at least one optical fiber can comprise three optical fibers. The at least one optical fiber can comprise a fiber between 10 microns and 200 microns, such as a 100 micron optical fiber. The at least one optical fiber can comprise an optical fiber with a circular cross section. The at least one optical fiber can comprise an optical fiber with a non-circular cross section. The access element can comprise a distal end, and the at least one optical fiber can comprise a distal end that is positioned at the distal end of the access element. The access element can comprise a distal end, and the at least one optical fiber can comprise a distal end that extends beyond the distal end of the access element. The access element can comprise a distal end, and the access device can be manufactured using a process that includes simultaneously polishing the distal end of the access element and a distal end of the at least one optical fiber. The at least one optical fiber can comprise a first optical fiber, a second optical fiber, and a third optical fiber, and the first optical fiber can be configured to transmit light received from the light source to the tissue, the second optical fiber can be configured to transmit a reference signal comprising light received from the light source to the detector, and the third optical fiber can be configured to transmit the reflected light to the detector. The sensor assembly can be configured to produce a signal related to a phase shift between the reference signal and the reflected light. [038] In some embodiments, the access element comprises a wall defining a conduit, a lighting wire, and a detector wire. The lighting wire and/or the detector wire can be embedded in the wall of the access element. The lighting wire and/or the detector wire can be located external to the wall of the access element. The lighting wire and/or the detector wire can be located within a lumen of the access element.

[039] In some embodiments, the sensor assembly comprises an ultrasound imaging assembly.

[040] In some embodiments, the sensor assembly comprises an electromagnetic energy imaging assembly. The sensor assembly can be configured to perform an impedance measurement.

[041] In some embodiments, the sensor assembly comprises a pressure sensor. The pressure sensor can be positioned on the distal portion of the access element and can be configured to determine if the port of the access element is within a blood vessel based on identification of a blood pressure signal corresponding to an anatomical location in which the access element is inserted.

[042] In some embodiments, the sensor assembly comprises an integrated circuit. The integrated circuit can comprise a light source, a light sensor, and a reference arm. The system can further comprise a single optical fiber that optically connects to the integrated circuit.

[043] In some embodiments, the access element and/or other portion of the access device comprises at least a portion of the sensor assembly. The at least a portion of the sensor assembly can comprise a communication filament selected from the group consisting of an optical fiber; a light pipe; a wire; a waveguide; and combinations thereof. The access element can comprise an outer surface, and the communication filament can be positioned on the outer surface of the access element. The system can further comprise a heat shrink tube or other tube that surrounds and secures the communication filament to the access element.

The access element can comprise a lumen, and the communication filament can be positioned within the lumen of the access element. The access element can comprise a luminal inner surface, and the communication filament can be positioned on the inner luminal surface of the access element. The access element can comprise a wall, and the communication filament can be positioned within the wall of the access element. The access element can comprise a plastic tube, and the communication filament can be molded in the wall of the access element. The access element can comprise an elongate channel, and the communication filament can be positioned in the elongate channel. The at least a portion of the sensor assembly can comprise an optical fiber.

[044] In some embodiments, the sensor assembly modulates a transmission used to produce the signal of the sensor assembly. The modulated transmission can comprise a modulated light-based transmission.

[045] In some embodiments, the sensor assembly is configured to deliver light from the port and/or from the distal portion of the access element. The sensor assembly can be configured to deliver light that is absorbed by blood but transmissive in non-blood tissue. [046] In some embodiments, the sensor assembly comprises a lock-in amplifier.

[047] In some embodiments, the access device further comprises a power supply. The power supply can comprise a battery, a capacitor, or both. The power supply can comprise a rechargeable power supply. The power supply can store sufficient energy for an access procedure of up to 90 minutes. The power supply can comprise a volume of no more than 2500mm3, 2000mm3, and/or 1500mm3.

[048] In some embodiments, the access device comprises a diagnostic assembly. The diagnostic assembly can be configured to detect one or more failure modes of the access device. The one or more failure modes can comprise improper insertion of the access element into the target location. The target location can comprise a venous access site comprising a vessel of the patient. The improper insertion can comprise penetration of both sides of the vessel. The one or more failure modes can comprise the loss of vascular access. [049] In some embodiments, the access device comprises a delivery control assembly. The system can further comprise an agent to be delivered to the target location by the access element, and the delivery control assembly can be configured to stop delivery of the agent to the target site when an undesired condition is detected by the system. The delivery control assembly can comprise a spring-based stopping mechanism. The delivery control assembly can comprise a magnetic-based stopping mechanism. The sensor assembly can be configured to detect the undesired condition. The delivery control assembly can be configured to automatically stop the delivery of the agent. The system can further comprise an alert assembly, and the delivery control assembly can be configured to activate the alert assembly when the undesired condition is detected, such that an operator can stop the delivery of the agent. The delivery control assembly can be further configured to remove from the patient at least a portion of the agent that has been delivered to the patient prior to the detection of the undesired condition. The delivery control assembly can be configured to remove from the patient at least a portion of the agent that has been delivered to the patient. The delivery control assembly can comprise a spring-based retraction mechanism configured to remove the at least a portion of the agent. The system can further comprise a reversal agent configured to reduce effects of an agent delivered to the patient, and the delivery control assembly can be configured to deliver the reversal agent when the undesired condition is detected. The reversal agent can be delivered via the access element. The access element can comprise a first lumen for delivering the agent and a second lumen for delivering the reversal agent. The access device can comprise a reservoir for storing the reversal agent. The delivery control assembly can comprise a spring-based delivery mechanism configured to deliver the reversal agent. The delivery control assembly can be configured to automatically deliver the reversal agent. The delivery control assembly can be configured to allow an operator to manually deliver the reversal agent. The reversal agent can comprise hyaluronidase.

[050] In some embodiments, the access device comprises a disposable portion and a reusable portion. The reusable portion can comprise at least a portion of the sensor assembly. The reusable portion can comprise a sterilizable portion of the access device.

[051] In some embodiments, the access device comprises a functional assembly. The sensor assembly can comprise a functional assembly. The functional assembly can be configured to deliver light. The delivered light can be configured to activate a medication administered to the patient. The access element can be configured to deliver the medication to the patient. The delivered light can be configured to promote healing of tissue of the patient. The delivered light can be configured to promote healing of tissue within and/or otherwise proximate the target location. The system can further comprise an agent to be delivered to the target tissue via the access element, and the delivered light can be configured to change a property of the delivered agent. The delivered light can be configured to change a property of the agent selected from the group consisting of: viscosity; density; color; crosslinking; and combinations thereof. The functional assembly can be configured to deliver energy. The delivered energy can be configured to provide a function selected from the group consisting of: to activate a medication; to promote healing; to change a property of the agent; to change a physical property of the agent; to change a chemical property of the agent; to provide a catalyst for a reaction; to enhance the absorption of the agent by tissue; to reversibly electroporate tissue; to treat tissue; to ablate tissue; to thermally ablate tissue; to irreversibly electroporate tissue; and combinations thereof. [052] In some embodiments, the access device further comprises a use detection assembly. The use detection assembly can be configured to detect each advancement of the access element through the skin surface of the patient.

[053] In some embodiments, the access device comprises a functional element. The functional element can comprise one or more transducers. The functional element can comprise one or more sensors. The functional element can comprise one or more accelerometers and/or other motion-detecting sensors configured to produce a signal related to motion of access element 110 and/or other component of system 10. The system can be configured to analyze the signal from the motion-detecting sensor to determine the speed, acceleration, location, and/or orientation of the access device.

[054] In some embodiments, the system further comprises an alert assembly configured to provide an alert. The alert assembly can be configured to indicate the detection of the target location being proximate the port of the access element. The alert assembly can be configured to indicate the detection of the non-target location being proximate the port of the access element. The alert assembly can be further configured to indicate the detection of the non-target location proximate the port of the access element. The alert assembly can be configured to provide a visual alert, an audible alert, and/or a tactile alert. The alert assembly can be configured to provide two or more of: a visual alert, an audible alert, and/or a tactile alert. The access device can comprise the alert assembly. The system can further comprise an operator device, and the operator device can comprise the alert assembly.

[055] In some embodiments, the system further comprises a processing unit comprising a processor and a memory storage element coupled to the processor, and the memory storage element stores instructions for the processor to perform an algorithm. The processing assembly can be configured to analyze the signal from the sensor assembly. The access device can comprise the processing assembly. The algorithm can comprise an Al algorithm. The sensor assembly can comprise a first sensor assembly configured to produce a first signal and a second sensor assembly configured to produce a second signal, and the algorithm receives the first signal and the second signal and detects the target location and/or detects the non-target location based on an analysis of the first signal and the second signal. The algorithm can comprise a bias. The sensor assembly can comprise a first sensor assembly configured to produce a first signal and a second sensor assembly configured to produce a second signal, and the algorithm receives the first signal and the second signal and detects the target location and/or detects the non-target location based on an analysis of the first signal, the second signal, and the bias. The algorithm can comprise a hysteresis-based algorithm (“hysteresis algorithm” herein). The algorithm can be configured to adjust the sensor assembly to account for patient-to-patient variability. The algorithm can be configured to differentiate a first tissue type from a second tissue type. The first tissue type can comprise healthy tissue and the second tissue type can comprise diseased tissue. The diseased tissue can comprise malignant tissue. The algorithm can be configured to perform a compensation routine. The compensation routine can be configured to compensate for one or more foreign substances present in blood and/or other tissue. The one or more foreign substances can comprise at least a chemotherapeutic. The one or more foreign substances can comprise a substance selected from the group consisting of an antibiotic, such as vancomycin, meropenem, and/or gentamicin; an antifungal medication, such as micafungin and/or amphotericin; a pain relief medication, such as hydromorphone and/or morphine; an agent for treating low blood pressure, such as dopamine, epinephrine, norepinephrine, and/or dobutamine; an intravenous immunoglobulin medication (IVIG); and combinations thereof. The one or more foreign substances can comprise the agent.

[056] In some embodiments, the sensor assembly is configured to produce a first signal and a second signal, and the first signal is related to tissue proximate the distal end of the access element, and the second signal is related to tissue proximate a proximal portion of the access element (e.g., a proximal portion of the distal portion of the access element). The algorithm can determine the location of the access element based on analysis of the first and second signals. The algorithm can determine if the access element is positioned within a blood vessel based on analysis of the first signal and the second signal. The algorithm can determine if the access element has been inserted through a blood vessel based on analysis of the first signal and the second signal.

[057] In some embodiments, the system further comprises a secondary agent.

[058] In some embodiments, the system further comprises a functional assembly. The functional assembly can comprise an infusion pump. The system can be configured to turn off the infusion pump if the non-target location is detected by the system. The system can be configured to provide an alarm if an undesirable condition is detected by the system. The system can be operably connected to an alarm system of a clinical setting, and the provided alarm can be provided by the alarm system. The undesirable condition can comprise an undesirable change in flow rate. The undesirable condition can comprise an undesirable change in pressure. [059] In some embodiments, the system further comprises a functional element.

[060] In some embodiments, the system further comprises a console configured to operably connect to the access device. The console can be configured to operably connect to the access device via a wired connection. The console can be configured to operably connect to the access device via a wireless connection. The console can comprise an IOT module. The console can be configured to upload data from the access device. The console can be configured to adjust operation of the access device via an analysis of the uploaded data. The data can comprise data selected from the group consisting of: serial number data; model number data; date of manufacture data; usage data; fault data; battery status data; and combinations thereof. The data can comprise data related to the number of times presence of blood was detected by the system during a procedure. The console can be configured to upload data selected from the group consisting of: patient data; procedural data; access device data; clinician data; environmental data; temporal data; and combinations thereof. The console can comprise a barcode reader and/or other data reader configured to record barcode or other data sources of the access device.

[061] In some embodiments, the system further comprises a server configured to communicate with the access device over a network. The system can further comprise one or more consoles configured to operably connect with the access device, and the access device can comprise multiple access devices, and the server can be configured to communicate with the one or more consoles and/or the multiple access devices. The server can be configured to collect usage information. The processing assembly can comprise an Al algorithm, and the system can be configured to train the Al algorithm based on the collected use information. [062] In some embodiments, the system further comprises an operator device. The operator device can be configured to alert the operator when a system alarm is encountered. The operator device can comprise a device selected from the group consisting of: watch; smart watch; wrist-worn device; cell phone; smart phone; tablet computer; a haptic alert device, such as a device comprising a vibrational transducer; audio alert device; and combinations thereof. The operator device can be configured to remotely control the access device and/or other component of the system. The operator device can be operably attached to the access device and/or other component of the system. The operator device can be operably attached to the access device and/or other component of the system via a wireless connection. [063] According to another aspect of the present inventive concepts, a method of accessing a target location comprises: selecting the system according to one or more claims herein; accessing a target location; delivering an agent and/or removing a body substance from the target location.

[064] The technology described herein, along with the attributes and attendant advantages thereof, will best be appreciated and understood in view of the following detailed description taken in conjunction with the accompanying drawings in which representative embodiments are described by way of example.

INCORPORATION BY REFERENCE

[065] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. The content of all publications, patents, and patent applications mentioned in this specification are herein incorporated by reference in their entirety. It will be clearly understood that, if a prior art publication is referred to herein, this reference does not constitute an admission that the publication forms part of the common general knowledge in the art in any country.

BRIEF DESCRIPTION OF THE DRAWINGS

[066] Fig. 1 illustrates a block diagram of an embodiment of a system for accessing a target location within a patient, consistent with the present inventive concepts.

[067] Fig. 1A illustrates a block diagram of another embodiment of a system for accessing a target location within a patient, consistent with the present inventive concepts. [068] Fig. 2 illustrates a perspective view of an embodiment of a device for accessing a target location and delivering an agent, consistent with the present inventive concepts.

DETAILED DESCRIPTION OF THE DRAWINGS

[069] Reference will now be made in detail to the present embodiments of the technology, examples of which are illustrated in the accompanying drawings. Similar reference numbers may be used to refer to similar components. However, the description is not intended to limit the present disclosure to particular embodiments, and it should be construed as including various modifications, equivalents, and/or alternatives of the embodiments described herein.

[070] It will be understood that the words "comprising" (and any form of comprising, such as "comprise" and "comprises"), "having" (and any form of having, such as "have" and "has"), "including" (and any form of including, such as "includes" and "include") or "containing" (and any form of containing, such as "contains" and "contain") when used herein, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof.

[071] It will be further understood that, although the terms first, second, third, etc. may be used herein to describe various limitations, elements, components, regions, layers and/or sections, these limitations, elements, components, regions, layers, and/or sections should not be limited by these terms. These terms are only used to distinguish one limitation, element, component, region, layer or section from another limitation, element, component, region, layer, or section. Thus, a first limitation, element, component, region, layer, or section discussed below could be termed a second limitation, element, component, region, layer, or section without departing from the teachings of the present application.

[072] It will be further understood that when an element (also referred to as a “component” herein) is described as being "on", "attached", "connected" or "coupled" to another element, it can be directly on or above, or connected or coupled to, the other element, or one or more intervening elements can be present. In contrast, when an element is referred to as being "directly on", "directly attached", "directly connected" or "directly coupled" to another element, there are no intervening elements present. Other words used to describe the relationship between elements should be interpreted in a like fashion (e.g., "between" versus "directly between," "adjacent" versus "directly adjacent," etc.).

[073] As used herein, the terms “operably attached”, “operably connected”, “operatively coupled” and similar terms related to attachment of components shall refer to attachment of two or more components that results in one, two, or more of electrical attachment; fluid attachment; magnetic attachment; mechanical attachment; optical attachment; sonic attachment; and/or other operable attachment arrangements. The operable attachment of two or more components can facilitate the transmission between the two or more components of power; signals; electrical energy; fluids or other flowable materials; magnetism; mechanical linkages; light; sound such as ultrasound; and/or other materials and/or components.

[074] It will be further understood that when a first element is referred to as being "in", "on" and/or "within" a second element, the first element can be positioned: within an internal space of the second element, within a portion of the second element (e.g. within a wall of the second element); positioned on an external and/or internal surface of the second element; and combinations of one or more of these.

[075] As used herein, the term “proximate”, when used to describe proximity of a first component or location to a second component or location, is to be taken to include one or more locations near to the second component or location, as well as locations in, on and/or within the second component or location. For example, a component positioned proximate an anatomical site (e.g., a blood or other fluid delivery location), shall include components positioned near to the anatomical site, as well as components positioned in, on and/or within the anatomical site.

[076] Spatially relative terms, such as "beneath," "below," "lower," "above," "upper", “under” and the like may be used to describe an element and/or feature's relationship to another element(s) and/or feature(s) as, for example, illustrated in the figures. It will be further understood that the spatially relative terms are intended to encompass different orientations of the device in use and/or operation in addition to the orientation depicted in the figures. For example, if the device in a figure is turned over, elements described as "below" and/or "beneath" other elements or features would then be oriented "above" the other elements or features. The device can be otherwise oriented (e.g., rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. [077] The terms “reduce”, “reducing”, “reduction” and the like, where used herein, are to include a reduction in a quantity, including a reduction to zero. Reducing the likelihood of an occurrence shall include prevention of the occurrence. Correspondingly, the terms “prevent”, “preventing”, and “prevention” shall include the acts of “reduce”, “reducing”, and “reduction”, respectively.

[078] The term "and/or" where used herein is to be taken as specific disclosure of each of the two specified features or components with or without the other. For example "A and/or B" is to be taken as specific disclosure of each of (i) A, (ii) B and (iii) A and B, just as if each is set out individually herein. [079] The term “one or more”, where used herein can mean one, two, three, four, five, six, seven, eight, nine, ten, or more, up to any number.

[080] The terms “and combinations thereof’ and “and combinations of these” can each be used herein after a list of items that are to be included singly or collectively. For example, a component, process, and/or other item selected from the group consisting of: A; B; C; and combinations thereof, shall include a set of one or more components that comprise: one, two, three or more of item A; one, two, three or more of item B; and/or one, two, three, or more of item C.

[081] In this specification, unless explicitly stated otherwise, “and” can mean “or”, and “or” can mean “and”. For example, if a feature is described as having A, B, or C, the feature can have A, B, and C, or any combination of A, B, and C. Similarly, if a feature is described as having A, B, and C, the feature can have only one or two of A, B, or C.

[082] As used herein, when a quantifiable parameter is described as having a value “between” a first value X and a second value Y, it shall include the parameter having a value of: at least X, no more than Y, and/or at least X and no more than Y. For example, a length of between 1 and 10 shall include a length of at least 1 (including values greater than 10), a length of less than 10 (including values less than 1), and/or values greater than 1 and less than 10.

[083] The expression “configured (or set) to” used in the present disclosure may be used interchangeably with, for example, the expressions “suitable for”, “having the capacity to”, “designed to”, “adapted to”, “made to” and “capable of’ according to a situation. The expression “configured (or set) to” does not mean only “specifically designed to” in hardware. Alternatively, in some situations, the expression “a device configured to” may mean that the device “can” operate together with another device or component.

[084] As used herein, the terms “about” or “approximately” shall refer to ± 20% of a stated value.

[085] As used herein, the term “threshold” refers to a maximum level, a minimum level, and/or range of values correlating to a desired or undesired state. In some embodiments, a system parameter is maintained above a minimum threshold, below a maximum threshold, within a threshold range of values, and/or outside a threshold range of values, such as to cause a desired effect (e.g. efficacious therapy) and/or to prevent or otherwise reduce (hereinafter “prevent”) an undesired event (e.g. a device and/or clinical adverse event). In some embodiments, a system parameter is maintained above a first threshold (e.g., above a first temperature threshold to cause a desired therapeutic effect to tissue) and below a second threshold (e.g., below a second temperature threshold to prevent undesired tissue damage). In some embodiments, a threshold value is determined to include a safety margin, such as to account for patient, user, and/or operator variability, system variability, tolerances, and the like. As used herein, “exceeding a threshold” relates to a parameter going above a maximum threshold, below a minimum threshold, within a range of threshold values and/or outside of a range of threshold values.

[086] As described herein, “room pressure” shall mean pressure of the environment surrounding the systems and devices of the present inventive concepts. Positive pressure includes pressure above room pressure or simply a pressure that is greater than another pressure, such as a positive differential pressure across a fluid pathway component such as a valve. Negative pressure includes pressure below room pressure or a pressure that is less than another pressure, such as a negative differential pressure across a fluid component pathway such as a valve. Negative pressure can include a vacuum but does not imply a pressure below a vacuum. As used herein, the term “vacuum” can be used to refer to a full or partial vacuum, or any negative pressure as described hereabove.

[087] The term “diameter” where used herein to describe a non-circular geometry is to be taken as the diameter of a hypothetical circle approximating the geometry being described. For example, when describing a cross section, such as the cross section of a component, the term “diameter” shall be taken to represent the diameter of a hypothetical circle with the same cross sectional area as the cross section of the component being described.

[088] The terms “major axis” and “minor axis” of a component where used herein are the length and diameter, respectively, of the smallest volume hypothetical cylinder which can completely surround the component.

[089] As used herein, the term “functional element” is to be taken to include one or more elements constructed and arranged to perform a function. A functional element can comprise a sensor and/or a transducer. In some embodiments, a functional element is configured to deliver energy. In some embodiments, a functional element is configured to treat tissue (e.g., a functional element configured as a treatment element). Alternatively or additionally, a functional element (e.g., a functional element comprising a sensor) can be configured to record one or more parameters, such as a patient physiologic parameter; a patient anatomical parameter (e.g., a tissue geometry parameter); a patient environment parameter; and/or a system parameter. In some embodiments, a sensor or other functional element is configured to perform a diagnostic function (e.g., to gather data used to perform a diagnosis). In some embodiments, a functional element is configured to perform a therapeutic function (e.g., to deliver therapeutic energy and/or a therapeutic agent). In some embodiments, a functional element comprises one or more elements constructed and arranged to perform a function selected from the group consisting of: deliver energy; extract energy (e.g. to cool a component); deliver a drug or other agent; manipulate a system component or patient tissue; record or otherwise sense a parameter such as a patient physiologic parameter or a system parameter; and combinations of one or more of these. A functional element can comprise a fluid and/or a fluid delivery system. A functional element can comprise a reservoir, such as an expandable balloon or other fluid-maintaining reservoir. A “functional assembly” can comprise an assembly constructed and arranged to perform a function, such as a diagnostic and/or therapeutic function. A functional assembly can comprise an expandable assembly. A functional assembly can comprise one or more functional elements.

[090] The term “transducer” where used herein is to be taken to include any component or combination of components that receives energy or any input, and produces an output. For example, a transducer can include an electrode that receives electrical energy, and distributes the electrical energy to tissue (e.g., based on the size of the electrode). In some configurations, a transducer converts an electrical signal into any output, such as: light (e.g. a transducer comprising a light emitting diode or light bulb), sound (e.g. a transducer comprising a piezo crystal configured to deliver ultrasound energy); pressure (e.g. an applied pressure or force); heat energy; cryogenic energy; chemical energy; mechanical energy (e.g. a transducer comprising a motor or a solenoid); magnetic energy; and/or a different electrical signal (e.g. different than the input signal to the transducer). Alternatively or additionally, a transducer can convert a physical quantity (e.g., variations in a physical quantity) into an electrical signal. A transducer can include any component that delivers energy and/or an agent to tissue, such as a transducer configured to deliver one or more of: electrical energy to tissue (e.g. a transducer comprising one or more electrodes); light energy to tissue (e.g. a transducer comprising a laser, light emitting diode and/or optical component such as a lens or prism); mechanical energy to tissue (e.g. a transducer comprising a tissue manipulating element); sound energy to tissue (e.g. a transducer comprising a piezo crystal); chemical energy; electromagnetic energy; magnetic energy; and combinations of one or more of these. [091] As used herein, the term “fluid” can refer to a liquid, gas, gel, or any flowable material, such as a material which can be propelled through a lumen and/or opening. [092] As used herein, the term “material” can refer to a single material, or a combination of two, three, four, or more materials.

[093] As used herein, the term “user interface” can comprise one or more interfaces, each interface comprising one or more components configured to receive an input from a user, “user input device” herein, and/or one or more components configured to provide output to a user, “user output device” herein. An input device can comprise one, two, three, or more components selected from the group consisting of: keyboard; a mouse; a button; a switch; a lever; a keypad such as a membrane keypad; a joystick; a touchscreen display; a microphone; a brain-machine-interface (e.g., a thought-control device); a camera, such as a camera with eye tracking, motion tracking, gesture identification, and/or other image processing capability configured to identify user input; a motion capture device, such as a camera and/or a device including one or more accelerometers and/or other motion-detecting sensors; a virtual input device, such as a virtual device comprising ultrasonic, image capture, and/or motion-based sensing of user inputs; a physiologic input sensor, such as a sensor configured to provide an input signal based on a user action, such as flexure of a muscle proximate the sensor; a scent detector, such as a detector configured to identify a pheromone or other scent produced by the user; other input component; and combinations of these. An output device can comprise one, two, three, or more components selected from the group consisting of: a visual output component such as a light and/or a display such as a touchscreen display; an audible output component such as a buzzer and/or a speaker; a haptic output component such as a vibrational transducer and/or an ultrasonic device configured to produce a tactile output; a brain-machine-interface; an augmented reality (AR) and/or a virtual reality (VR) output device, such as glasses or a headset including a non-transparent display, a transparent display, and/or a “heads up” display where information is presented to the user in an overlay manner; a scent output device configured to produce an aromatic output, such as a computerized scent output; other output component; and combinations of these.

[094] The terms “data” and “information” are used interchangeably herein.

[095] As used herein, the term “access” can refer to providing access to a location within a patient for delivery of fluids or other materials, and/or removal of fluids or other materials. [096] As used herein, a “blood vessel of an organ” can comprise a blood vessel that supplies blood to the organ, such as an artery that supplies blood to the organ, a blood vessel on or within the organ, such as an artery, vein, and/or capillary within the organ, and/or a blood vessel that receives blood from the organ, such as a vein that receives blood from the organ.

[097] It is appreciated that certain features of the inventive concepts, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the inventive concepts which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination. For example, it will be appreciated that all features set out in any of the claims (whether independent or dependent) can be combined in any given way. [098] It is to be understood that at least some of the figures and descriptions of the inventive concepts have been simplified to focus on elements that are relevant for a clear understanding of the inventive concepts, while eliminating, for purposes of clarity, other elements that those of ordinary skill in the art will appreciate may also comprise a portion of the inventive concepts. However, because such elements are well known in the art, and because they do not necessarily facilitate a better understanding of the inventive concepts, a description of such elements is not provided herein.

[099] Terms defined in the present disclosure are only used for describing specific embodiments of the present disclosure and are not intended to limit the scope of the present disclosure. Terms provided in singular forms are intended to include plural forms as well, unless the context clearly indicates otherwise. All of the terms used herein, including technical or scientific terms, have the same meanings as those generally understood by an ordinary person skilled in the related art, unless otherwise defined herein. Terms defined in a generally used dictionary should be interpreted as having meanings that are the same as or similar to the contextual meanings of the relevant technology and should not be interpreted as having ideal or exaggerated meanings, unless expressly so defined herein. In some cases, terms defined in the present disclosure should not be interpreted to exclude the embodiments of the present disclosure.

[100] Provided herein are systems, devices, and methods for delivery of one or more agents to a patient, and/or removal of one or more substances from a patient. A system for accessing a “target location” within a patient can comprise an access device, a sensor assembly, and a processing assembly. The access device can comprise an access element comprising a distal portion and can be configured to access the target location. The sensor assembly can be configured to produce a signal related to tissue and/or other materials proximate the target location (e.g. related to tissue or other material within and/or otherwise proximate the target location). The processing assembly can be operably connected to the sensor assembly and can be configured to process the signal from the sensor assembly. The processing assembly can be configured to detect and/or confirm the target location (e.g., detect and/or confirm by identifying a target tissue type) and/or to detect and/or confirm one or more “non-target locations” (e.g. detect and/or confirm one or more non-target locations by identifying one or more non-target tissue types), such as locations to which access should be avoided, such as a location to which delivery of an agent should be avoided.

[101] Referring now to Fig. 1, a block diagram of an embodiment of a system for accessing a target location within a patient is illustrated, consistent with the present inventive concepts. System 10 can be configured to access a “target location” of a patient, such as to provide fluid access or other access to the target location, such as to deliver one or more agents to that target location and/or remove one or more substances from the target location. System 10 can be further configured to avoid accessing a “non-target location” of a patient, such as one or more non-target locations to which providing access should be avoided (e.g., the delivery of the one or more agents should be avoided and/or removal of one or more substances should be avoided). System 10 includes one or more patient access devices, access device 100 shown. Access device 100 can include one or more access elements, access element 110 shown, that can be configured to provide access and/or provide other access to a target location (e.g., a target location comprising one or more target locations). Access device 100 can be configured to detect (e.g., detect and/or confirm) and/or to avoid, minimize harm to, and/or otherwise protect tissue or other material of a non-target location (e.g., a non-target location comprising one or more non-target locations). Access device 100 can be configured to provide percutaneous access to a target location, such as an epidermal, dermal, and/or subdermal target location. Access element 110 can comprise distal portion 118 that is configured to be positioned within or otherwise proximate the target location, such as to provide access to the target location. Access element 110, (e.g., distal portion 118) can comprise one or more output and/or input openings, port 119 shown, such that access device 100 can deliver material through port 119, and/or remove material through port 119. Port 119 can comprise one or more openings on the distal end of access element 110. Alternatively, or additionally, port 119 can comprise one or more side holes on the side of access element 110. As described herein, system 10 can include one or more sensors that are configured to produce signals related to tissue proximate access element 110 (e.g., at least the tissue proximate distal portion 118), and one or more processing units that are configured to process the signals of the one or more sensors. The signals can be related to tissue and/or other material proximate the target location, and the processing unit can be configured to detect the target location and/or to detect one or more non-target locations, such as to detect when a portion of access element 110 (e.g., port 119) is positioned proximate a target and/or a nontarget location.

[102] System 10 can be configured to access a target location comprising a tissue location of a patient, such as a human or other mammalian or non-mammalian patient, “patient” herein. Additionally, or alternatively, system 10 can be configured to diagnose, monitor, and/or treat a patient, for example to treat a patient by delivering one or more agents to the patient, such as agent 20 shown, the one or more agents delivered via access device 100. Alternatively, or additionally, access device 100 can be configured to deliver energy to a target location, such as via access element 110. As used herein, a “user”, “operator”, and/or “clinician” of system 10 can refer to a doctor, nurse, clinician, and/or other healthcare professional, that uses access device 100 and/or other component of system 10 in a medical procedure (e.g., a diagnostic procedure, a treatment procedure, or both). In some embodiments, a user of system 10 comprises the patient into which access device 100 provides access to a target location of the patient, such as to accommodate patient-performed medical procedures (e.g., patient self-injected medication procedures).

[103] System 10 of Fig. 1 can include similar components and can otherwise be of similar construction and arrangement to system 10 described in reference to Fig. 1 A and/or other figures described herein.

[104] Access device 100 can provide access to a target location for the delivery of agent 20 to the target location (e.g., a target location within a blood vessel to receive agent 20, a target location comprising solid tissue to receive agent 20, or other target location to which agent 20 is to be delivered), where system 10 is configured to avoid delivery of the agent to an undesired location (a “non-target location”). Alternatively, or additionally, access device 100 can provide access to a target location to allow removal of a body substance (e.g., blood, marrow, lymphatic fluid, and/or other body substance as described herein) from the target location, where system 10 is configured to avoid removal of material from an unintended location (a “non-target location”). Alternatively, or additionally, access device 100 can provide access to a target location to allow subsequent access of one or more additional devices, such as when access device 100 provides for placement of a guidewire over which an introducer or other device is inserted to access the target location, where system 10 is configured to avoid providing access to an unintended location (a “non-target location”). As used herein, “providing access to” and/or “accessing” a target location can include either or both of: providing access to and performing an action (e.g., delivery of agent 20) at a location within or at least proximate a target location.

[105] System 10 can be configured to perform a “cosmetic procedure”, such as a cosmetic procedure in which an agent 20 comprising an agent configured to produce a cosmetic effect is delivered to one or more target locations. The agent 20 can be delivered to tissue of a target location (“target tissue” herein). In these embodiments, the agent 20 can comprise one, two, or more agents selected from the group consisting of: cosmesis improvement agent; a filler; a dermal filler; hyaluronic acid; fat such as autologous fat; calcium hydroxyapatite; poly-l-lactic acid (PLLA); polyalkylimide; polymethyl-methacrylate microspheres (PMMA); a neurotoxin; a plastic; platelet rich plasma (PRP); collagen; silicone; vitamins (such as Vitamin C) or products derived from vitamins (such as retinoids or niacinamide); oils or lipids (such as ceramides); proteins (such as elastin) or amino acids (such as betaine); enzymes (such as lipase or hyaluronidase); organic acids (such as alpha hydroxy acids, glycolic acid or lactic acid); botanicals or plant extracts (such as aloe vera or caffeine); water and/or ice slurry; and/or combinations of these. In a cosmetic procedure, access device 100 can be configured to provide access to one, two, or more target locations selected from the group consisting of: the forehead; the temples; the zygoma (cheekbone); the anterior cheek; the lateral cheek; the medial cheek; the tear trough; the scalp; the nose; the lips; the chin; the side of the chin; Marionette lines; the nasolabial fold; the subzygoma; the jawline; the palpebromalar groove; the jowls; the neck; platysma bands; the arms; the buttocks; the upper lip; the lower lip; the hands; the chest; the breasts; the legs; the knees; the feet; areas around the eyes; eyebrows; glabella; ears; a supraperiosteal location; scar tissue; vaginal area; and/or combinations of these. Cosmetic target locations can comprise target tissue selected from the group consisting of: dermal tissue; epidermal tissue; hypodermal tissue; subcutaneous tissue; tissue at the dermal subcutaneous junction; muscle; fat; and/or combinations of these. In some embodiments, agent 20 is configured to treat a cosmetic condition (e.g., sunken eyes) and/or to perform a cosmetic augmentation (e.g., brow augmentation and/or lip augmentation). In some embodiments, system 10 is configured to remove a body substance from a first target location of a patient (e.g., using a first access device 100a), and deliver that body substance (e.g., further processed or unprocessed body substance) to a second target location of the patient (e.g., using the first access device 100a or a second access device 100b), In some embodiments, a target location for delivery of agent 20 comprises a location proximate a blood vessel (e.g., a blood vessel of an eye or other organ), proximate a nerve, and/or proximate an organ, such as when system 10 is configured to prevent delivery of agent 20 into the blood vessel, the nerve, and/or the organ and/or to prevent compression of the blood vessel and/or damage to the nerve and/or organ, as described herein.

[106] In some embodiments, system 10 is configured to perform a medical procedure (e.g., a non-cosmetic medical procedure) comprising: collecting tissue (e.g., a biopsy) and/or collecting other material from a location within the patient; delivering an agent 20 (e.g., an agent 20 comprising a medication and/or a diagnostic agent) to a location within the patient; implanting a device within the patient; positioning an introducer device into the patient; and/or performing another therapeutic and/or diagnostic medical procedure where access device 100 provides access to a target location. For example, access device 100 can provide access to one or more target locations selected from the group consisting of: a cosmetic target location (e.g., as listed above); an artery; a vein; a duct; a conduit of the spine such as the epidural space and/or the intrathecal space; a bone (e.g., a location within a bone); an organ such as the brain, the heart, the liver, the pancreas, the stomach, the bladder; the small intestine; the large intestine; a kidney, a lung, a breast, and/or other organ; a gland; and/or combinations of these. Additionally, or alternatively, access device 100 can provide access to a target location comprising target tissue selected from the group consisting of: tissue to be treated to improve patient cosmesis; blood; tumor tissue; abnormal tissue; tissue to be biopsied; dermal tissue; epidermal tissue; tissue of an organ; scar tissue and/or combinations of these. Agent 20 can comprise an agent selected from the group consisting of: a cosmetic agent; a pharmaceutical agent; a biologic agent, a chemotherapeutic agent; an anticoagulant; an analgesic; a radioisotope, such as a liquid radioisotope; an antibiotic, such as vancomycin, meropenem, and/or gentamicin; an antifungal agent, such as micafungin and/or amphotericin; a pain relief medication, such as hydromorphone and/or morphine; an antiparasitic, such as albendazole; an agent for treating low blood pressure, such as dopamine, epinephrine, norepinephrine, and/or dobutamine; an intravenous immunoglobulin medication (IVIG); a hormonal agent, such as estrogen; a steroid, such as methyl prednisone; an enzyme, such as lipase; a protein; a peptide, such as protein C concentrate; a monoclonal antibody, such as IgG; an amino acid, such as lysine; blood; plasma and/or other blood component; cells; and/or combinations of these.

[107] System 10 can include one or more sensor assemblies, sensor assembly 200 shown. Sensor assembly 200 can include one, two, or more sensors, sensor 250 shown, such as one, two, or more sensors that are configured to record one or more patient parameters and/or one or more parameters related to the location (e.g., a current location relative to tissue of the patient) of access element 110. Sensor assembly 200 can communicate (e.g., transfer data) with access device 100 and/or other components of system 10, as described herein. In some embodiments, access device 100 comprises all or a portion of sensor assembly 200 (e.g., when sensor 250 and/or at least a portion of sensor assembly 200 is integrated into access device 100, as described herein). Sensor assembly 200 can be configured to provide one or more signals (e.g., one or more light-based and/or other sensor signals, as described herein) that are used by system 10 to differentiate between different tissue types that may be present at an output portion (e.g., a distal opening, a side opening, or both) of access element 110, such as to cause an agent (e.g., agent 20) to be delivered to an intended location (a “target location”) and/or prevent the agent from being delivered to an unintended location (a “non-target location”). Similarly, signals provided by sensor assembly 200 can be configured to provide one or more signals (e.g., one or more light-based and/or other sensor signals, as described herein) that are used by system 10 to differentiate between different tissue types that may be present at an input portion (e.g., a distal opening, a side opening, or both) of access element 110, such as to cause material (e.g., blood or other body fluids, a biopsy, and the like) to be removed from an intended location (a “target location”) and/or prevent material from being removed from an unintended location (a “non-target location”).

[108] System 10 can include one or more consoles, console 300 shown. Console 300 can be configured to operably connect to access device 100, for example to provide an agent, such as agent 20, to access device 100 (e.g., via a fluid connection), and/or to transfer energy (e.g., electrical energy, light energy, mechanical energy, chemical energy, sound energy, and/or other energy) and/or data (e.g., control signals, sensor data, and/or other data) between console 300 and access device 100. Console 300 can provide a user interface (e.g., as described herein) for the input of commands and/or other information from an operator of system 10, and/or for the output of information from system 10 to the operator. [109] System 10 can include one or more user devices, operator device 700 shown. Operator device 700 can provide a user interface (e.g., as described herein) for the input of commands and/or other information from an operator of system 10, and/or for the output of information from system 10 to the operator. In some embodiments, one or more portions of operator device 700 are integrated into access device 100 (e.g., when access device 100 is configured to receive input from and/or provide output to an operator). Additionally, or alternatively, access device 100 can comprise operator device 700 (e.g., when system 10 does not include an operator device that is separate from access device 100). In some embodiments, one or more portions of operator device 700 are integrated into console 300. Additionally, or alternatively, console 300 comprises operator device 700 (e.g., when system 10 does not include an operator device that is separate from console 300, and the components and/or functionalities of operator device 700 described herein are provided by console 300).

[110] Operator device 700, access device 100, console 300, and/or another component of system 10 can be configured to alert an operator when a system alarm is encountered, and/or when an undesired or other notable state of system 10 is detected (e.g., when alert assembly 400 of Fig. 1 A provides an alert based on the detection of an undesired condition, completion of an event, or other notable event, as described herein). Operator device 700 can comprise a device selected from the group consisting of a watch; a smart watch; a wrist- worn device; a cell phone; a smart phone; a tablet computer; a haptic alert device, such as a device comprising a vibrational transducer; an audio alert device; and combinations thereof. In some embodiments, operator device 700 is configured to transmit one or more commands (e.g., via communication module 70 of Fig. 1 A) to console 300 and/or access device 100, such as to remotely control access device 100 and/or another component of system 10. Operator device 700 can be configured to communicate with access device 100 and/or another component of system 10, such as via a wireless connection.

[111] System 10 can include one or more functional assemblies, such as functional assembly 90 shown. Functional assembly 90 can include one or more functional elements, such as functional element 99 shown. One or more components of system 10, such as access device 100, sensor assembly 200, console 300, and/or operator device 700 can each include a functional assembly 90 and/or functional element 99, such as when functional assembly 190 and/or 290 and/or functional elements 199, 299, 399, and/or 799, respectively, each shown, comprise a functional assembly 190 and/or functional element 99, respectively. Singly or collectively, various functional assemblies described herein can individually or collectively be referred to as “functional assembly 90”. Furthermore, various functional elements described herein can individually or collectively be referred to as “functional element 99”. Functional element 99 (e.g., functional element 99, 199, 299, 399, and/or 799) can comprise one or more sensors, one or more transducers, or both. Functional assembly 90 can comprise one or more assemblies configured to perform a function (“functional assembly” herein). Functional element 99 can comprise one or more physiologic sensors configured to measure a physiologic parameter of the patient, an operator of system 10, or both. Functional element 99 can comprise one, two, or more physiologic sensors selected from the group consisting of: blood pressure sensor; flow sensor (e.g., blood flow sensor); heart rate sensor; respiration sensor; blood glucose sensor; blood gas sensor; tissue temperature sensor; neuronal spike sensor; electroencephalogram (EEG) sensor; local field potential (LFP) sensor; and/or combinations of these. Functional element 99 can comprise a sensor configured to produce a signal related to the environment (e.g., the environment of the patient during a procedure performed using system 10), such as one, two, or more sensors selected from the group consisting of: temperature sensor; humidity sensor; atmospheric pressure sensor; room light sensor; a sound sensor (e.g., a microphone and/or an ultrasound transducer); GPS sensor; and/or combinations of these. Functional element 99 can comprise one, two, or more sensors selected from the group consisting of: pressure sensor; strain gauge; temperature sensor; flow sensor; accelerometer and/or other motion-detecting sensor; and/or combinations of these. Functional element 99 can comprise one, two, or more transducers selected from the group consisting of: a heating transducer; a cooling transducer; a Peltier element; a thermoelectric element; a vibrational transducer; a vacuum-providing element; a light-producing element; a sound producing element (e.g. a speaker and/or an ultrasound transducer); and/or combinations of these. In some embodiments, functional element 99 comprises a tool, such as a calibration tool as described herein.

[112] In some embodiments, functional element 99 comprises one or more accelerometers and/or other motion-detecting sensors that are each configured to produce a signal related to at least a portion of access device 100 and/or a signal related to patient motion (e.g., a respiration sensor configured to produce a signal related to patient motion). For example, functional element 99 can be configured to produce a signal that can be processed by a processing unit (e.g., processing unit 50 described herein) to determine the speed, acceleration, location, and/or orientation of at least a portion of access device 100 (e.g., of access element 110, such that system 10 can account for motion of and/or determine a location of access element 110). In some embodiments, functional element 199 (e.g., an accelerometer or other functional element) is located on and/or integral to access element 110.

[113] Access device 100 can include one or more reservoirs for storing agent 20 (or other material), reservoir 130 shown. Reservoir 130 includes one or more internal voids, chamber 132, for storing agent 20. In some embodiments, reservoir 130 comprises two or more reservoirs, for example when agent 20 comprises two or more agents, such as two or more different agents, and/or two or more agents comprising different concentrations (e.g., different dosages).

[114] Access device 100 can include one, two, or more supplies of energy, power supply 160. Power supply 160 can be configured to provide electrical power and/or other energy (e.g., pressure and/or other stored potential mechanical energy) to access device 100. In some embodiments, power supply 160 comprises an electrical energy storage assembly, such as one or more batteries and/or capacitors. Additionally, or alternatively, power supply 160 can comprise a pressure source, a spring, and/or other stored energy source. In some embodiments, power supply 160 is configured to provide electrical energy to one or more electronic components of access device 100. In some embodiments, power supply 160 is configured to provide non-electrical energy to one or more components of access device 100. In some embodiments, power supply 160 comprises a rechargeable power supply. Power supply 160 can store sufficient energy in order to “complete” one or more similar or different medical procedures (e.g., a procedure with a duration of up to 90 minutes). In some embodiments, power supply 160 comprises a volume PSV. Volume PSV can comprise a volume of no more than 2500mm³, such as a volume of no more than 2000mm³, or 1500mm³.

[115] Access device 100 can include one or more casings that at least partially enclose various components of the device, housing 101 shown. For example, housing 101 can surround at least a portion of reservoir 130. In some embodiments, housing 101 comprises two or more distinct housings, such as when access device 100 comprises two or more portions that are removably attachable to each other, for example as described herein.

[116] Referring additionally to Fig. 1A, a block diagram of another embodiment of a system for accessing a target location within a patient is illustrated, consistent with the present inventive concepts. In some embodiments, one or more components of system 10 of Fig. 1 A are of similar construction and arrangement to the similar components described in reference to Fig. 1 and/or otherwise herein.

[117] System 10 can include one or more data processing modules, processing unit 50 shown, that can be configured to perform, control, and/or monitor one or more of the functions of system 10 (e.g., as described herein). For example, processing unit 50 can be configured to perform and/or facilitate one or more processes, data collections, data analyses, data transfers, signal processing functions, agent deliveries, positioning of access elements, flow monitoring, monitoring of one or more patient parameters, and/or other functions of system 10 (“functions of system 10”, “system 10 functions” or simply “system functions” herein). Processing unit 50 can comprise one or more electronic elements, electronic assemblies, and/or other electronic components, such as components selected from the group consisting of: microprocessors; microcontrollers; state machines; memory storage components; analog-to-digital converters; rectification circuitry; filters and other signal conditioners; sensor interface circuitry; transducer interface circuitry; and/or combinations of one, two, or more of these. For example, processing unit 50 can include at least one processor and at least one memory storage component, such as processor 51 and memory 52, each shown. Memory 52 can be coupled to processor 51, and memory 52 can store one or more sets of computer instructions, instructions 53 shown. Instructions 53 can comprise instructions used by processor 51 to perform one or more algorithms of system 10. For example, system 10 can comprise one or more algorithms, algorithm 55 shown, that are performed by processor 51. Additionally, or alternatively, instructions 53 can comprise instructions for running one or more applications of system 10, for example application 56 shown. Processing unit 50 can be configured to “run” application 56, such that application 56 can initiate, modify, stop, and/or otherwise control the performance of various functions of access device 100 and/or of another component system 10. In some embodiments, application 56 is configured to receive input from an operator of system 10, for example via a user interface (e.g., user interface 60 described herein). In some embodiments, algorithm 55 can comprise one or more machine learning, neural net, and/or other artificial intelligence algorithms (“Al algorithm” herein). All or a portion of one or more processing units 50 can be integrated into one, two, or more of the various components of system 10, such as access device 100, console 300, a server (e.g., server 80 described herein), and/or other component of system 10. Performance of a function of system 10 is described hereabove as being performed by processing unit 50. Alternatively, or additionally, the performance of a function of system 10 can be described herein, interchangeably, as being performed by algorithm 55 and/or system 10. For example, “algorithm 55 being configured to perform an action, a routine, and/or another function” can be interpreted as processing unit 50 and/or system 10 being configured to perform the action, routine, and/or other function, and vice versa.

[118] System 10 can include one or more user interfaces, user interface 60 shown. User interface 60 can provide and/or receive information to and/or from an operator of the system (e.g., a clinician and/or other user of system 10). User interface 60 can include one or more user input components and/or output components. For example, user interface 60 can comprise a keyboard, mouse, touchscreen, and/or other human interface and/or other input component (e.g., as described herein), user input device 61. In some embodiments, user interface 60 comprises a speaker, indicator light, haptic transducer and/or other human interface and/or other output component (e.g., as described herein), user output device 62. In some embodiments, user output device 62 comprises a video output component, such as display 63 shown. Display 63 can comprise a touchscreen display, for example when user input device 61 and user output device 62 collectively comprise display 63. In some embodiments, processing unit 50 is configured to provide an interactive graphical interface, GUI 65, such as a graphical user interface provided by application 56. GUI 65 can be displayed (e.g., displayed to an operator of system 10) via display 63. In some embodiments, user interface 60 and/or GUI 65 comprise a virtual reality and/or augmented reality interface. One or more components of system 10 can comprise one or more portions of a user interface 60, such as access device 100, console 300, operator device 700, and/or other components of system 10 described herein.

[119] System 10 can include one or more communication modules, communication module 70 shown. One or more devices of system 10 can comprise one or more portions of a communication module 70, such as access device 100, sensor assembly 200, console 300, operator device 700, and/or other components of system 10 described herein.

Communication module 70 can be configured to provide communication between (e.g., transfer commands, delivery information, patient information, and/or other data between) two or more components of system 10, such as via wired and/or wireless communication. For example, communication module 70 can include one or more transmitters and/or receivers, transceiver 71 shown. Transceiver 71 can comprise a wireless transceiver, such as a Bluetooth transceiver, a Near Field Communication (NFC) transceiver, a Wi-Fi transceiver, a cellular transceiver, a satellite-connected transceiver, and/or other short-range and/or long- range wireless transceiver. A wireless connection can include a short-range wireless connection, such as an NFC connection and/or a Bluetooth low energy (BLE) connection. In some embodiments, communication module 70 is configured to transfer data via an acoustic signal, such as an acoustic signal that is outside of the auditory range of the operator. In some embodiments, communication module 70 is configured to communicate via one or more wired and/or wireless networks, such as network 75 shown. Network 75 can include a wireless network, such as a cellular network, LAN, WAN, VPN, the Internet, and/or other wireless network connecting two or more devices. In some embodiments, network 75 comprises a wired network, and/or a network including wired and wireless devices.

[120] Communication module 70 can be configured to transfer data between at least a first component of system 10 and at least a second component of system 10, as described herein. In some embodiments, the first component of system 10 comprises access device 100. The second component can comprise another component of system 10, for example sensor assembly 200, console 300, and/or operator device 700, such as an operator device 700 comprising a smart device, such as a smartphone, a smartwatch, and/or a tablet.

[121] In some embodiments, system 10 includes one or more servers, server 80 shown, that can be configured to provide data storage and/or data processing for the providers of system 10 (e.g., the manufacturer and/or distributor of system 10) and/or the users of system 10. As used herein, data processing can refer to the receiving of data, processing of data, transmission of data (e.g., transmitting the results of data processing), and/or the storage of data, such as data received from multiple consoles 300 and/or multiple access devices 100 located at multiple clinical sites. Server 80 can comprise one or more processing units 50. Additionally, or alternatively, server 80 can include one or more data storage units for storing data collected by system 10, data 85 shown. In some embodiments, server 80 is configured to process data from various users of system 10, for example when the provider of system 10 maintains one or more servers 80 configured to process data for each (and/or a subset) of the users of system 10 (e.g., each of the patients and/or clinicians of system 10). Server 80 can comprise an “off-site” server (e.g., remotely located from the users of system 10), such as a server owned, maintained, and/or otherwise provided by the provider of system 10.

Alternatively, or additionally, server 80 can comprise a cloud-based server.

[122] In some embodiments, communication module 70 is configured to enable one or more components of system 10 to connect to an Internet of Things (loT) network. For example, communication module 70 can include loT module 72 that is configured to connect to an loT network, such as to exchange data (e.g., data 85) with other loT devices and/or cloud-based services (e.g., services that are provided by the provider of system 10 and/or third-party providers). In some embodiments, two or more components of system 10 each comprise an loT module 72, such that the two or more components can operate as an loT system, for example when each of the two or more components form a private loT network (e.g., a network of system 10 devices only), and/or when the components connect to a public loT network (e.g., a network including devices outside of system 10 devices).

[123] In some embodiments, at least a portion of system 10 comprises a temporary use component (e.g., limited use component) and/or disposable component (e.g., single use component), either referred to as “disposable” herein. For example, access device 100 can be a disposable device, and/or device 100 can include one or more disposable portions, each disposable portion configured to be used for a limited number of uses (e.g., for use in a single clinical procedure, and/or for a single injection of agent 20), and then to be replaced. In some embodiments, system 10 comprises one or more single use disposable components, and/or multi-use (“reusable” and/or “multi-use” herein) disposable components, wherein the multiuse reusable components (e.g., all or a portion of a device, assembly or other component) are transferred at least from a first component of system 10 (e.g., a first access device 100) to a second component of system 10 (e.g., a second access device 100). In some embodiments, the multi-use disposable component is transferred to a third system 10 component (e.g., a third access device 100), and so on, but the transfers are limited to a maximum (e.g., two, three, or four transfers). Additionally, or alternatively, system 10 can comprise one or more single and/or multi-use disposable components that are configured to be used for a maximum time period (e.g., as included in one, two, or more access devices 100 or other system 10 component). For example, access device 100 or other component of system 10 can comprise a first portion that is configured to be used for a first maximum time period, and/or a maximum number of uses, and a second portion that is configured to be used for a second maximum period, and/or a maximum number of uses, where the second period or number of uses is shorter or less than the first period or number of uses, such as when the first portion is configured to work with two or more second portions (e.g., as the second portion is replaced). In some embodiments, access device 100 comprises an entirely disposable access device, as described herein. In some embodiments, a reusable portion of system 10 comprises at least a portion of sensor assembly 200. In some embodiments, one or more reusable portions of system 10 can be cleanable and/or sterilizable (e.g., re-sterilizable) between uses.

[124] In some embodiments, access device 100 includes at least a portion of processing unit 50, at least a portion of user interface 60, and/or at least a portion of communication module 70, such as when access device 100 comprises processing unit 105, user interface 106, and/or communication module 107, respectively, each shown.

[125] In some embodiments, access device 100 comprises at least a portion of sensor assembly 200, sensor assembly 120 shown. For example, sensor assembly 120 can comprise one or more of sensors 250, sensor 125 shown. Sensor 125 can comprise one, two, or more sensors where each sensor can be configured to record (e.g., produce a signal related to) various parameters related to the location of access element 110, parameters of the delivery of agent 20 and/or other parameters related to the functionality of access device 100.

[126] In some embodiments, one or more processing units of system 10, referred to singly or collectively herein as processing unit 50, can be configured to receive and analyze a signal provided by sensor assembly 200. As described herein, system 10 can be configured to differentiate between different tissue types that may be present at an output portion of access element 110, such as to cause an agent (e.g., agent 20) to be delivered to an intended location (a “target location”) and/or prevent the agent from being delivered to an unintended location (a “non-target location”). Algorithm 55 can be configured to analyze signals (e.g., light-based signals) from sensor assembly 200 to differentiate a first tissue type (e.g., a nonblood tissue) from a second tissue type (e.g., blood). Algorithm 55 can be further configured to differentiate one or more tissue types from air. In some embodiments, sensor assembly 200 comprises a first sensor assembly 200a configured to produce a first signal and a second sensor assembly 200b configured to produce a second signal, and processing unit 50 can be configured to analyze (e.g., by executing algorithm 55 via processor 51) the first and the second signals. Processing unit 50 can be configured to detect a target location (e.g., detect target tissue), and/or detect one or more non-target locations, based on the analysis of the first and second signals (e.g., based on a comparison of the first and second signals).

[127] In some embodiments, algorithm 55 comprises one or more biases, for example a bias configured to apply a “weighting factor” (e.g., favor, apply more importance to, and the like) the result of the analysis of the first signal greater than the result of the analysis of the second signal. For example, processing unit 50 can be configured to detect a target location and/or a non-target location (e.g., one or more non-target locations) based on both the analysis of the first and second signals, where algorithm 55 comprises a bias, such as when the bias applies one or more weighting factors to the results of an analysis of the first signal, the second signal, or both.

[128] In some embodiments, algorithm 55 comprises a “ hysteresis algorithm”, such as an algorithm that is configured to make one or more determinations based on one or more current signals that are received by sensor assembly 200 and on one or more signals previously received from sensor assembly 200.

[129] In some embodiments, algorithm 55 is configured to adjust one or more parameters of sensor assembly 200 and/or another component of system 10, and/or to adjust the analysis of signals received from sensor assembly 200 and/or another component of system 10, such as to account for patient-to-patient variability. For example, algorithm 55 can comprise an Al algorithm or other algorithm that receives information related to a patient being treated, and adjusts one or more parameters of sensor assembly 200 and/or another component of system 10 based on the information of the patient being treated. One or more memory storage components of system 10 (e.g., memory 52 described herein), can store lookup tables of information that correlate specific patient information to settings of one or more parameters to be used in a procedure on a particular patient performed using system 10. In some embodiments, system 10 stores (e.g., and algorithm 55 is configured to determine a system 10 parameter based on) one, two, or more patient parameters selected from the group consisting of: gender; hemoglobin level; hematocrit level; Fitzpatrick skin type; presence of anemia and/or other patient condition or disease; and combinations of these. In some embodiments, algorithm 55 is configured to determine a system 10 parameter (e.g., a light delivery parameter; a threshold, or other system 10 parameter) based on two or more of: gender; hemoglobin level; hematocrit level; Fitzpatrick skin type; and/or presence of anemia and/or other patient condition or disease.

[130] In some embodiments, algorithm 55 is configured to differentiate a first tissue type (e.g., blood) from a second tissue type (e.g., one or more non-blood tissue types). In some embodiments, algorithm 55 is configured to differentiate one or more tissue types (e.g., at least blood), from a non-tissue (e.g., air). Algorithm 55 can be configured to perform a “compensation routine”, such as a compensation routine configured to adjust the analysis of one or more signals produced by sensor assembly 200. For example, algorithm 55 can comprise a compensation routine that is configured to adjust the analysis of the one or more signals produced by sensor assembly 200 based on the presence of one or more “foreign substances” (e.g., a medication) in the blood and/or other tissue of the patient. One or more foreign substances that are present in tissue (e.g., blood) can change the reflectivity of the tissue (e.g., blood) and/or otherwise change a property of the tissue (e.g., blood), where that property can be used by system 10 to detect the presence of a particular type of tissue (e.g., detect the presence of blood within a blood vessel into which delivery of agent 20 should be avoided). Algorithm 55 can be configured to compensate for the presence of a foreign substance comprising a chemotherapeutic that is present in the blood or other tissue of the patient. In some embodiments, a foreign substance requiring compensation by algorithm 55 comprises a substance selected from the group consisting of: an antibiotic, such as vancomycin, meropenem, and/or gentamicin; an antifungal drug, such as micafungin and/or amphotericin; a pain relief medication, such as hydromorphone and/or morphine; an agent for treating low blood pressure, such as dopamine, epinephrine, norepinephrine, and/or dobutamine; an intravenous immunoglobulin medication (IVIG); and/or combinations of these. In some embodiments, the foreign substance to be compensated for by algorithm 55 comprises agent 20.

[131] In some embodiments, algorithm 55 can be configured to perform a compensation routine that is configured to compensate for motion of sensor assembly 200 (e.g., where an optical fiber or other sensor portion of sensor assembly 200 is positioned in a moving access element 110). Applicant has conducted studies in which motion of a sensor assembly 200 (e.g., a fiber-optic based sensor assembly 200 configured to deliver light and receive reflections of that light) impacts the signal produced (e.g., a signal based on the light received) by the sensor assembly 200. A functional element 199 or other functional element comprising an accelerometer and/or other motion-detecting sensor can be configured to record the motion, and to compensate for the impact on the signal of sensor assembly 200 due to the motion.

[132] System 10 can include one or more assemblies that are configured to alert an operator of system 10, alert assembly 400 shown. Alert assembly 400 can include one or more alert elements, alert element 410 shown, where the one or more alert elements provide a visible, audible, tactile, and/or other signal to an operator to indicate a warning and/or other alert condition of system 10. In some embodiments, alert assembly 400 is configured to provide an alert, via alert element 410, indicating an alert condition to an operator (e.g., an undesired or other event or condition has occurred and/or is present). All or a portion of one or more alert assemblies 400 can be integrated into one, two, or more of the various components of system 10, such as access device 100 and/or other component of system 10. For example, access device 100 can comprise at least a portion of alert assembly 400, alert assembly 140 shown. Alternatively, or additionally, console 300 and/or operator device 700 can comprise at least a portion of alert assembly 400. In some embodiments, alert assembly 400 is configured to alert an operator if motion (e.g., advancement or retraction) of access element 110 exceeds a threshold. In these embodiments, a functional element 199 comprising an accelerometer and/or other motion sensing sensor can provide a signal (e.g., to algorithm 55), such that alert assembly 400 can detect undesired motion (e.g., via algorithm 55), and alert the operator (e.g., such that the operator can slow down the advancement or retraction, such as to maintain the integrity of the detection of a particular tissue type by sensor assembly 200).

[133] In some embodiments, alert element 410 of alert assembly 400 comprises two or more alert elements. For example, alert assembly 400 can comprise a first alert element 410a and a second alert element 410b. In some embodiments, the first and second alert elements 410 are independently activatable (e.g., to independently alert the operator to different alert conditions of system 10). In some embodiments, alert assembly 400 comprises a first alert element 410a comprising a tactile alert element (e.g., a haptic transducer), and a second alert element 410b comprising a non-tactile alert element, such as an indicator light, a speaker, and/or other output device that alerts the operator to an alert condition. In some embodiments, one alert element 410a is activated when a first alarm condition is met, and a second alert element 410b is activated when a second alarm condition is met (e.g., where both the first and second alert elements 410 are activated if both alert conditions are encountered at the same time).

[134] System 10 can be configured to allow an operator (e.g., a clinician) to set and/or adjust one or more alert thresholds for a set of one or more parameters that are monitored by system 10 (e.g., one or more parameters that are monitored by sensor assembly 200, as described herein). When a threshold of a monitored parameter is exceeded, alert assembly 400 can be configured to alert one or more users of system 10, for example the patient’s clinician. For example, system 10 can be configured to allow an operator to set and/or adjust an alert threshold related to: excessive motion (e.g., velocity, acceleration, or both); a target tissue threshold (e.g., a light level associated with target tissue and/or other target tissue identification level); a non-target tissue threshold (e.g., a light level associated with non- target tissue and/or other non-target tissue identification level); an ambient light level; and/or combinations of these.

[135] In some embodiments, alert assembly 400 is configured to indicate (e.g., activate an alert element based 410 on) the detection of the target location being proximate port 119 of access element 110 (e.g., as access element 110 is inserted into the patient). Additionally, or alternatively, alert assembly 400 can be configured to indicate (e.g., activate an alert element 410 based on) the detection of one or more non-target locations being proximate port 119 of access element 110.

[136] System 10 can include one or more assemblies that are configured to detect one or more failure modes of one or more components of system 10, diagnostic assembly 500 shown. Diagnostic assembly 500 can be configured to detect one or more failure modes of access device 100 and/or other components of system 10, as described herein. Diagnostic assembly 500 can comprise one or more sensors to produce sensor signals, and/or it can receive sensor signals from sensor assembly 200 and/or another component of system 10 (e.g., a functional element 99). All or a portion of one or more diagnostic assemblies 500 can be integrated into one, two, or more of the various components of system 10, such as when integrated into access device 100 and/or another component of system 10. For example, access device 100 can comprise at least a portion of diagnostic assembly 500, diagnostic assembly 150 shown.

[137] In some embodiments, for example when system 10 is configured to deliver agent 20 to a target location (e.g., one or more target locations) of a patient, access device 100 can include components configured to control the delivery of agent 20, delivery control assembly 170 shown. Delivery control assembly 170 can be configured to stop (or prevent) the delivery of agent 20 when an undesired condition is detected, such as an undesired condition that is detected by processing unit 50 based on one or more signals recorded by sensor assembly 200 and/or diagnostic assembly 500. For example, delivery control assembly 170 can be configured to stop delivery of agent 20 when access element 110 (e.g., the distal end, an output port, or other delivery portion of access element 110) is not positioned at a target location (e.g., positioned at a non-target location). Alternatively, or additionally, delivery control assembly 170 can be configured to stop delivery of agent 20 when signals provided by sensor assembly 200 may be suspected as being inaccurate, such as when: undesired motion is detected (e.g., as detected by a functional element 199 and/or other element 99 comprising an accelerometer and/or other motion-detecting sensor); power supply 160 is below a threshold level; the patient is in an undesired state (e.g., unacceptable blood pressure, high heart rate, and/or other undesired patient condition as detected by a functional element 99 comprising a patient physiologic sensor); patient environment at an unacceptable state (e.g., undesired level of temperature, humidity, or other patient environment parameter); and/or combinations of these.

[138] As described herein, system 10 can be configured to deliver one or more agents, such as agent 20, to a target location via access element 110. Processing unit 50, such as by performing algorithm 55, can be configured to detect an undesired event that occurs in a procedure in which agent 20 is intended to be delivered to the target location (e.g., delivered to target tissue of the target location). For example, processing unit 50 can be configured to detect: undesired delivery of agent 20 into a blood vessel (e.g., a blood vessel of an eye or other organ) and/or delivery of agent 20 that results in agent 20 entering a blood vessel (e.g., a blood vessel of an eye or other organ); delivery of agent 20 that causes undesired compression of a blood vessel (e.g., a blood vessel of an eye or other organ); and/or damage to a nerve.

[139] System 10 can be configured to prevent (e.g., automatically prevent) delivery of agent 20 to a non-target location. For example, processing unit 50, such as by performing algorithm 55, can be configured to detect one or more non-target locations, for example to detect when access element 110 is positioned such that delivery of agent 20 via access element 110 would result in a delivery of agent 20 to a non-target location. Delivery control assembly 170 can be configured to prevent (e.g., block a flow path, prevent advancement of a plunger or other fluid propulsion element, and/or otherwise automatically prevent) delivery of agent 20 when access element 110 is positioned such that agent 20 would be delivered to a non-target location. In some embodiments, a non-target location comprises a blood vessel and/or a tissue location proximate a blood vessel. Additionally, or alternatively, a non-target location can comprise nerve tissue and/or tissue proximate a nerve.

[140] In some embodiments, diagnostic assembly 500 is configured to detect the loss of vascular access, for example to detect if access element 110 is unintentionally removed from a blood vessel (e.g., a vein or an artery), such as during an infusion of drugs or other agent 20, and/or during a blood withdrawal. For example, during administration of agent 20 comprising chemotherapy drugs, diagnostic assembly 500 can be configured to detect loss of vascular access. If vascular access is lost, in order to prevent delivery of agent 20 to surrounding tissues (e.g., tissue surrounding the vascular access site), delivery control assembly 170 can be configured to stop the delivery of agent 20 (e.g., prevent any delivery of agent 20 or stop an already initiated delivery). In some embodiments, diagnostic assembly 500 is configured to detect an improper insertion of access element 110, such as an improper insertion into a vascular access site for an infusion of agent 20. For example, diagnostic assembly 500 can be configured to determine if access element 110 has penetrated both sides of a blood vessel (e.g., where agent 20 would be infused outside of the blood vessel). In some embodiments, delivery control assembly 170 is configured to prevent the initiation of an infusion (e.g., via an infusion pump and/or intravenous bag, such as an infusion pump and/or intravenous bag of system 10) if a proper insertion of access element 110 is not detected (e.g., not confirmed), and/or an improper insertion is detected (e.g., detected by diagnostic assembly 500). In some embodiments, delivery control assembly 170 is configured to prevent continuation of an infusion (e.g., an already initiated infusion via an infusion pump and/or intravenous bag, such as an infusion pump and/or intravenous bag of system 10) if a proper insertion of access element 110 is lost (e.g., a change in position is detected, or a lack of proper position information is present).

[141] Functional assembly 190 of access device 100 can include a functional element that is configured to detect when access device 100 is in-use and/or has been used, use detection assembly 191. As used herein, a “single use” of access device 100 can comprise a single insertion of access element 110 through the skin surface of a patient. Alternatively, or additionally, a “single use” can comprise a single delivery of a volume of agent 20 via access element 110 that includes more than one insertion and/or removal from the skin of the patient (e.g., to allow for removal and repositioning of access element 110 prior to any agent 20 being delivered). In some embodiments, a “use” of access device 100 comprises one or more “usage steps”, such as one or more insertions of access element 110 into the patient (e.g., where distal portion 118 is inserted percutaneously through the skin surface into the patient and/or through a natural orifice into a body cavity of the patient), one or more removals of access element 110 from the patient (e.g., where access element 110 is completely removed from the patient), one or more “repositioning” steps (e.g., where the placement and/or the trajectory of access element 110 is adjusted based on output provided to the operator that is based on signals recorded related to the tissue proximate port 119 and the surrounding tissue), and/or one or more injections of an agent (e.g., agent 20). In some embodiments, use detection assembly 191 is configured to detect each particular use, including each insertion, removal, repositioning, and/or injection performed by access device 100. In some embodiments, access element 110 is configured to be inserted along an insertion trajectory, trajectory IT. Trajectory IT can extend from a skin penetration location, location SP to a target location. In some embodiments, access element 110 comprises an insertable portion (e.g., at least distal portion 118) comprising a straight geometry, such that trajectory IT comprises a straight trajectory. Alternatively, or additionally, access element 110 can comprise a non-straight portion, such as a portion comprising a curvilinear geometry, a flexible portion, and/or a steerable portion, such that trajectory IT can comprise a non-straight trajectory. In some embodiments, trajectory IT comprises an advancement pathway, pathway AP, extending from the distal end of access element 110 to the target tissue (e.g., where the pathway AP decreases in length as access element 110 is inserted along trajectory IT). In some embodiments, processing unit 50 is configured to process signals received from sensor assembly 200 to determine if the target location and/or one or more non-target locations are positioned along advancement pathway AP of access element 110 as it is inserted into the patient. Use detection assembly 191 can be configured to detect (e.g., and count) each occurrence of an insertion, removal, repositioning, and/or injection performed by access device 100. In some embodiments, functional element 199 of access device 100 comprises a position, orientation, and/or movement sensor, such as an accelerometer and/or other motion-detecting sensor that is configured to produce a signal based on the movement of access device 100. Use detection assembly 191 can be configured to process signals received from functional element 199 to determine when a usage step has been performed. [142] In some embodiments, console 300 includes at least a portion of processing unit 50, at least a portion of user interface 60, and/or at least a portion of communication module 70, such as when console 300 comprises processing unit 305, user interface 306, and/or communication module 307, respectively, each shown. Console 300 can be configured to operably connect to one or more other components of system 10, such as to access device 100 (e.g., multiple access devices 100). Console 300 can operably connect to access device 100 via a wired and/or a wireless connection, such as via a connection provided between communication module 107 of access device 100 and communication module 307 of console 300. In some embodiments, console 300 comprises loT module 72. Console 300 can be configured to receive data, such as data 85 (e.g., to “upload” data 85) from access device 100, from user interface 306, from communication module 307, and/or other component of system 10. In some embodiments, console 300 is configured to adjust one or more parameters of the operation of access device 100, for example, based on the analysis of data 85. In some embodiments, data 85 comprises data that is specific to and/or otherwise used to identify each access device 100 and/or other components of system 10, such as identification data selected from the group consisting of serial number data; model number data; date of manufacture data; usage data; fault data; battery status data; and/or combinations of these. In some embodiments, console 300 is configured to upload data selected from the group consisting of patient data; procedural data; access device data; clinician data; environmental data; temporal data; and combinations thereof. In some embodiments, functional element 399 of console 300 comprises a data reader, such as a barcode reader, RFID reader, or other reader configured to read and/or otherwise receive data related to a component of system 10. Access device 100, access element 110, storage device 25, and/or other components of system 10 can each comprise a data source, such as a barcode, RFID, or other data source configured to be read by and/or otherwise transfer identification or other data to console 300 (e.g., via functional element 399 comprising a data reader). In some embodiments, access device 100 and/or other components of system 10 can be provided to a clinical setting in multiple, different forms (e.g., different configurations often referred to as different “models”). For example, a first access device 100a and a second access device 100b can be provided to a clinical setting for performing different procedures (e.g., procedures performed on different anatomical locations of one, two, or more patients, procedures delivering different agents 20 to one, two, or more patients, and/or other differences). In these embodiments, a data source can be included in each component, and used by system 10 to properly identify the configuration of the different components (e.g., differentiate access device 100a from 100b), such as to identify one or more particular settings to be used, and/or to perform another function that is associated with the different access devices 100 being used.

[143] In some embodiments, data 85 includes data recorded during a procedure, for example the number of times blood was detected during a procedure (e.g., when blood comprises non-target tissue). In some embodiments, data 85 comprises: data collected from multiple patients (e.g., data used to train an Al-based algorithm 55); data representing anatomical locations of access performed using access device 100; data representing type, volume, or other parameter of agent 20; and/or other data.

[144] In some embodiments, server 80 is configured to communicate with one or more access devices 100, such as communication provided via network 75 between communication module 107 and server 80, and/or between communication module 107 and communication module 307 of console 300, where console 300 is configured to communicate with one or more access devices 100, and server 80 is configured to communicate with one or more consoles 300 (e.g., to communicate via network 75). In some embodiments, server 80 is configured to collect data 85, for example data 85 comprising usage information (e.g., access device 100 usage information). In some embodiments, algorithm 55 comprises an Al algorithm, where the Al algorithm is trained based on usage data collected by server 80 (e.g., data 85 described herein and/or other data). In these embodiments, algorithm 55 can be configured to provide “suggestions” of one or more settings for system 10 operational parameters to be used on: a particular patient; a particular patient type; a particular procedure type (e.g., delivery of a particular agent 20); and/or combinations of these. Alternatively, or additionally, algorithm 55 can be configured to change (e.g., automatically change) one or more settings for system 10 operational parameters to be used on: a particular patient; a particular patient type; a particular procedure type (e.g., delivery of a particular agent 20); and/or combinations of these. In these configurations, system 10 can include the requirement for the operator (e.g., a clinician) to confirm any or all changes to system 10 operational parameters made by algorithm 55 (e.g., via a ’’clinician confirmation routine” of system 10). [145] System 10 can include one or more containers for holding an agent, storage device 25 shown. Storage device 25 can be configured to store one or more agents (agent 20), for example prior to injection into a patient (e.g., prior to the transfer of agent 20 to reservoir 130, as described herein). In some embodiments, agent 20 is transferred from storage device 25 to reservoir 130 of access device 100 prior to injection of agent 20 into the patient. In some embodiments, storage device 25 comprises a bar code, an RFID, and/or other agent 20 identifying information that can be automatically uploaded into access device 100, console 300, and/or other component of system 10. In these embodiments, one or more system 10 operational parameters that are based on the particular agent 20 can be automatically entered into and/or used by system 10 in the delivery of agent 20, such as parameters related to: particular target tissues to receive agent 20; particular non-target tissues (e.g., blood) that should not receive agent 20; minimum, maximum, and/or target delivery rates of agent 20; minimum, maximum, and/or target volumes of agent 20 to be delivered to a particular target location; and/or combinations of these. In some embodiments, system 10 includes one or more additional agents (e.g., agents that may or may not be injected into a patient during a clinical procedure where agent 20 is injected into the patient), such as second agent 30 shown. System 10 can include one or more containers for holding second agent 30, such as storage device 35 shown.

[146] In some embodiments, second agent 30 comprises an agent configured to counteract, neutralize, and/or otherwise reverse one or more effects caused by the delivery of agent 20 to the patient, reversal agent 31 shown. In some embodiments, reversal agent 31 is delivered (e.g., automatically and/or manually delivered) into a blood vessel into which agent 20 has unintentionally (e.g., and undesirably) been delivered.

[147] As described herein, access device 100 can be configured to remove one or more portions of tissue or other substance from the patient, body substance 40 shown. For example, access device 100 can be configured to perform a biopsy, where body substance 40 is removed from a target location that is accessed by access element 110 comprising a biopsy element. System 10 can include one or more containers for holding body substance 40 (e.g., following removal from the body of the patient), such as storage device 45 shown. Storage devices 25, 35 and/or 45 may be referred to herein, singly or collectively, as storage device 25.

[148] Agent 20 can include one or more additives, additive 21 shown, such as one or more additives that are configured to provide a clinical and/or procedural benefit beyond the intended benefit of agent 20. In some embodiments, additive 21 is configured to minimize migration of agent 20 beyond the target location to which agent 20 is injected. For example, additive 21 can comprise beads that are configured to reduce the migration of agent 20. Alternatively, or additionally, additive 21 can comprise a glue configured to reduce the migration of agent 20, such as when agent 20 comprises a liquid radioisotope configured to be delivered into a tumor, and additive 21 comprises a glue configured to limit migration of agent 20 outside of the tumor. In some embodiments, additive 21 can be configured to reduce pain and/or to reduce bleeding caused by the injection of agent 20, for example when additive 21 comprises epinephrine and/or an analgesic such as lidocaine. In some embodiments, system 10 is configured to determine (e.g., automatically determine via algorithm 55) the amount of additive 21 to be delivered, such as an amount that is based on one or more parameters of the particular patient, the particular target location, and/or the particular agent 20 being delivered to the patient.

[149] In some embodiments, agent 20 comprises a “treatment agent”, such as an agent that is delivered to the patient to treat a disease or other ailment. The target location in which to deliver agent 20 can comprise a blood vessel, for example when agent 20 comprises an agent that is delivered systemically (e.g., via the venous system) to the patient by access element 110. Agent 20 can comprise a treatment agent (e.g., a treatment agent that is delivered systemically by access device 100) selected from the group consisting of: a pharmaceutical agent; a chemotherapeutic agent; an antibiotic; an anticoagulant; an analgesic; a radioisotope; and combinations thereof. For example, agent 20 can comprise a chemotherapeutic agent and/or a radioisotope (e.g., a liquid radioisotope). In some embodiments, the target location comprises tumor tissue (e.g., tumor tissue that receives a chemotherapeutic agent and/or a radioisotope). In some embodiments, agent 20 comprises a sclerotherapy agent, for example when the target location comprises a vein of the patient (e.g., a spider vein or varicose vein that is to be occluded). In some embodiments, agent 20 comprises a biological agent, for example an agent comprising a material selected from the group consisting of: blood; plasma or other blood component; cells; and/or combinations of these.

[150] As described herein, system 10 can be configured to remove a body substance 40 from a target location using access device 100 (e.g., when substance 40 is removed via access element 110). In some embodiments, body substance 40 comprises a substance selected from the group consisting of: blood; fat; connective tissue; muscle; lymphatic fluid; dermal tissue; tumor tissue, such as tumor tissue from the skin or other parts of the body; marrow; and/or combinations of these. In some embodiments, system 10 is configured to prevent removal of body substance 40 from a non-target location. For example, processing unit 50, such as by performing algorithm 55, can be configured to detect one or more non-target locations, for example to detect when access element 110 is positioned such that removal of body substance 40 via access element 110 would result in removal of body substance from a non-target location (e.g., result in removal of an undesired body substance from a non-target location).

[151] As described herein, one or more components of system 10 can include at least a portion of processing unit 50, for example processing units 105 and/or 305 of access device 100 and console 300, respectively, each comprising at least a portion of processing unit 50. Various processing units of system 10 can be referred to singly or collectively herein, as processing unit 50. Processing unit 50, for example by performing algorithm 55 via processor 51, can be configured to detect a target location, detect a non-target location, or both. For example, processing unit 50 can be configured to detect when port 119 of access element 110 is positioned proximate a target location, proximate a non-target location, or both. [152] In some embodiments, a target location comprises a location outside of a blood vessel, such as when the target location includes tissue proximate the wall of a blood vessel. In these embodiments, the non-target location can comprise locations near and/or within the blood vessel (e.g., the wall or other tissue of the blood vessel and/or the lumen of the blood vessel). Alternatively, or additionally, the target location can comprise a location within the lumen of a blood vessel, for example, when agent 20 is configured to be delivered systemically via the venous system, such as when agent 20 comprises a systemically delivered medication. Additionally, or alternatively, for example when the target location comprises a blood vessel, access device 100 can be configured to deliver blood (e.g., to transfuse agent 20 comprising blood and/or a blood component) and/or to remove blood (e.g., to remove body substance 40 comprising blood).

[153] In some embodiments, a target location comprises a location within 10mm, or 20mm, of one or more nerves, and the non-target location comprises the one or more nerves (e.g., when system 10 is configured to avoid damaging the one or more nerves).

[154] In some embodiments, the target location comprises epidural space and/or intrathecal space. For example, when agent 20 comprises an analgesic, system 10 can be configured to safely and effectively access and deliver agent 20 to the epidural and/or intrathecal space, while avoiding non-target locations proximate the epidural and/or intrathecal space.

[155] As described herein, system 10 can be configured to differentiate between a first tissue type and a second tissue type. For example, sensor assembly 200 can produce a signal based on tissue proximate an output portion of access device 100 (e.g., port 119 of access device 100), and processing unit 50 can be configured to differentiate the tissue type based on the signal produced by sensor assembly 200 (e.g., one or more light signals and/or other sensor signals). In some embodiments, processing unit 50 is configured to differentiate between healthy tissue and diseased tissue, such as to differentiate malignant (e.g., cancerous) tissue from healthy tissue.

[156] As described herein, system 10 can be configured to deliver agent 20 comprising a cosmesis improving agent to a target location that is located proximate to one or more non- target locations. For example, system 10 can be configured to deliver agent 20 to a target location of the face of the patient that is proximate one or more non-target locations comprising one or more blood vessels, for example, one or more blood vessels of the eye (e.g., when the target location comprises skin or other tissue proximate the eye of the patient).

[157] In some embodiments, processing unit 50 is configured to detect inflammation of tissue (e.g., blood vessel tissue and/or other tissue), for example to detect inflammation of tissue proximate port 119 of access element 110 (e.g., when port 119 is positioned proximate a target and/or a non-target location). For example, processing unit 50 can be configured to detect inflammation of a blood vessel and/or inflammation of the tissue surrounding a blood vessel (e.g., based on an analysis of received light signals, image data, and/or other data, via sensor assembly 200 and/or diagnostic assembly 500). Additionally, or alternatively, processing unit 50 can be configured to detect increased blood flow at a location and/or to detect “redness” of tissue. For example, diagnostic assembly 500 can comprise a visual diagnostic assembly (e.g., a camera), and processing unit 50 can be configured to process image data received from diagnostic assembly 500 to detect redness and/or other visual indicators of a patient condition (e.g., visual indicators of a potential undesired condition related to a procedure being performed by system 10). For example, processing unit 50 can be configured to detect one or more patterns and/or changes in the optical and/or spectral properties of tissue, such as to detect inflammation of the tissue (e.g., where delivery of an agent 20 to the patient is not initiated, or stopped during delivery, such as by delivery control assembly 170, based on the detection of the inflammation).

[158] In some embodiments, access device 100 is configured to provide access (e.g., fluid access) to a target location, such as when access element 110 includes one or more fluid conduits, lumen 113, that extend from a proximal portion of access element 110 to distal portion 118, such as when port 119 is positioned on the distal end of element 110. Alternatively, or additionally, access element 110 can comprise a port 119 comprising one or more side holes that are proximal to the distal end of access element 110 and are fluidly connected to lumen 113.

[159] Access device 100 can be configured to provide access to deliver and/or remove a non-fluid material to and/or from a target location, such as to remove body substance 40 comprising a non-fluid tissue. Access device 100 can be configured to deliver an agent, such as agent 20 and/or to remove a substance, such as body substance 40, via access element 110 (e.g., via port 119 and lumen 113). As described herein, access device 100 can comprise reservoir 130 for storing a material, such as agent 20. Reservoir 130 can include multiple reservoirs, such as two, three, or more reservoirs. Reservoir 130 can comprise a fillable and/or refillable (“fillable” herein) reservoir, such as a reservoir that is configured to be filled with agent 20 prior to an injection of agent 20 (e.g., when agent 20 is transferred from storage device 25 to reservoir 130).

[160] In some embodiments, alert assembly 400 is configured to provide an alert when port 119 is positioned within a pre-determined distance of one or more locations, such as within a pre-determined distance of one or more target locations and/or one or more nontarget locations. For example, processing unit 50 can be configured to determine, by processing data received by sensor assembly 200, when port 119 is approaching a non-target location, such as a non-target location comprising a blood vessel, and alert assembly 400 can be configured to provide an alert when the proximity of port 119 to a target location and/or a non-target location is within a pre-determined threshold distance. In some embodiments, an alert signal provided by assembly 400 is modulated, changed in tone or volume, or otherwise modified as the proximity to the target location and/or non-target location changes. In some embodiments, alert assembly 400 is configured to provide a first form of alert (e.g., a tone at a first frequency) when port 119 is positioned near target tissue, and a second form of alert, different than the first form (e.g., a tone at a frequency different than the first) when port 119 is positioned near non-target tissue.

[161] In some embodiments, one or more components of system 10 are configured to be calibrated. For example, one or more components of access device 100 can be configured to be calibrated. In these embodiments, system 10 can comprise a “calibration routine”, such as when one or more adjustable assemblies, components, and/or settings are adjusted (e.g., during a manufacturing process of a system 10 component, or by a user of system 10 just prior to use) to compensate for: environmental conditions; changes to a system 10 component that occur over time; particular agent 20 being delivered; a particular anatomical site being accessed; and/or a particular clinician’s technique and/or preference.

[162] In some embodiments, a calibration routine of system 10 is configured to account for variability between different sensor assemblies 200, such as differences in light delivering and/or receiving portions of a sensor assembly 200 (e.g., an assembly 200 portion at the end of one or more optical fibers positioned at port 119 of access element 110). “Calibration information” can be produced during the performance of the calibration routine, and the calibration information can be used by algorithm 55 to compensate for sensor assembly 200 variability. The calibration configurations performed by system 10 can be a single point calibration, a multi-point calibration, or both. In some embodiments, this calibration information is included (e.g., in an RFID tag or other data storage element) with the particular access element 110 or sensor assembly 200 (e.g., embedded in access element 110 or sensor assembly 200 or in the packaging materials in which the component is shipped and/or stored). A calibration routine of system 10 can both confirm proper operation of the sensor assembly 200 (e.g., of access element 110), as well as provide calibration information which can be used by algorithm 55 to compensate for the particular performance of the sensor assembly 200.

[163] The calibration routine can comprise measuring and/or comparing light delivered and light received (e.g., light reflected back and received) from a known tissue or other known material (a “light reflectance test”). For example, a calibration routine can include placing a particular light emitting and collecting portion (e.g., the end of one or more optical fibers positioned at port 119 of access element 110) of a sensor assembly 200 to be calibrated in proximity to a functional element 99 comprising a calibration tool. The tool-based functional element 99 can comprise a highly reflective surface (e.g., polytetrafluoroethylene, PTFE, such as white PTFE) in order to measure and/or compare light delivered and light reflected back from the tool-based functional element 99. The calibration information would include the results of the measurement and/or comparison.

[164] In some embodiments, during a calibration routine, a light delivery and receiving portion of sensor assembly 200 (e.g., access element 110) is positioned in a tool-based functional element 99 comprising a housing with a calibration light-source that can deliver light at particular (e.g., varying or constant) intensity, bandwidth, dispersion, shape, and/or frequency. The housing of the tool-based functional element 99 can be configured as an integrating sphere. In some embodiments, the distance between the light receiving portion of sensor assembly 200 and the tool-based functional element 99 is adjusted. The receiving portion of the sensor assembly 200 being calibrated can receive the known light produced by the tool -based functional element 99 (e.g., light of known intensity, bandwidth, dispersion, shape, and/or frequency) and produce calibration information based on the output of sensor assembly 200 when exposed to the known light.

[165] In some embodiments, a calibration routine of system 10 comprises a light reflectance test procedure configured to compensate for light reflectance that varies between one portion (e.g., one type) of tissue and another (e.g., of the same patient, or between different patients). This calibration routine can comprise a light reflectance test performed using the light emitting and receiving portion of sensor assembly 200 when tested on one or more known tissue types, with the calibration information comprising the associated data collected.

[166] In some embodiments, access device 100 comprises a syringe-like device. For example, reservoir 130 can comprise a syringe barrel containing agent 20, and access element 110 can be coupled to the syringe barrel. Access device 100 can include a plunger positioned within reservoir 130, where the movement of the plunger into the barrel forces agent 20 through lumen 113 and port 119 of access element 110 into the patient (e.g., into the patient location where port 119 is positioned). Alternatively, or additionally, a plunger can be withdrawn from the barrel of reservoir 130, such as to withdraw body substance 40 from the patient via port 119 of access element 110.

[167] Access element 110 can be configured to pierce the skin of the patient, for example, to provide access to a target location beneath the surface of the skin of the patient. In some embodiments, access element 110 is configured to provide access to a target location for an access time period ATP. Time period ATP can comprise a period of at least one hour, such as at least 3 days, at least 1 week, and/or at least 1 month.

[168] Access element 110 can comprise a needle or other filament, such as a needle including an elongate shaft, shaft 114, with lumen 113 extending at least partially therethrough. Shaft 114 can comprise a size of at least 32 gauge, such as at least 30 gauge. Additionally, or alternatively, shaft 114 can comprise a size of no more than 23 gauge, such as no more than 6 gauge. For example, shaft 114 can comprise a size of 21 gauge, 25 gauge, or 27 gauge. Shaft 114 can comprise a sharpened distal tip. In some embodiments, shaft 114 comprises a beveled distal tip. In some embodiments, shaft 114 comprises an anti -coring tip.

[169] In some embodiments, access element 110 comprises multiple access elements, for example at least a first access element 110a and a second access element 110b. In some embodiments, the first access element 110a and the second access element 110b comprise different properties. For example, the first and second access elements 110 can comprise differing properties selected from the group consisting of: different diameters; different lengths; different materials of construction; different levels of rigidity; different configurations of distal ends; different locations of one or more ports 119; and/or combinations of these.

[170] In some embodiments, access element 110 comprises a needle. Alternatively, or additionally, access element 110 can comprise a cannula (e.g., a soft cannula). In some embodiments, access element 110 comprises a needle that is positioned within a cannula, for example a needle that is configured to provide access to a target location and then to be removed from the cannula, with the cannula remaining in place and providing continued access to the target location. In some embodiments, access element 110 comprises an element configured to provide access for additional components of system 10, such as surgical or other devices (e.g., laparoscopic surgical devices and/or intravenous lines). For example, access element 110 can comprise a trocar, a laparoscopic port, an introducer such as a vascular introducer, or other body access device. In some embodiments, access element 110 comprises a glass filament, such as a glass needle.

[171] In some embodiments, lumen 113 comprises multiple lumens, for example two, three, or more lumens each extending at least a portion of the length of access element 110 (e.g., at least a portion of the length of shaft 114), fluidly connecting to one or more ports, port 119 as described herein. In some embodiments, multiple lumens 113 comprise staggered distal ends (e.g., including staggered ports 119), such as when each lumen 113 exits shaft 114 at a different location and/or with a different rotational orientation along shaft 114 (e.g., different locations of multiple ports 119 within distal portion 118 of access element 110).

[172] In some embodiments, access element 110 comprises a connector assembly, hub 115, that is positioned at the proximal end of shaft 114. Hub 115 can be configured to operably attach access element 110 to another component of access device 100, such as to removably attach access element 110 to reservoir 130 and to provide a fluid connection between chamber 132 and lumen 113. Hub 115 can comprise a diameter of no more than 30mm, 25mm, and/or 20mm.

[173] In some embodiments, access element 110 comprises one or more coatings, such as coating 1141 of shaft 114. Coating 1141 can comprise a coating selected from the group consisting of a lubricious coating; a hydrophilic coating; a hydrophobic coating; an ultrasonically reflective coating; a radiopaque coating; a conductive coating, such as an electrically and/or thermally conductive coating; a magnetic coating; and/or combinations of these.

[174] In some embodiments, sensor 250 of sensor assembly 200 comprises at least one light source, light source 251 and at least one detector, detector 252, each shown. Light source 251 can comprise a static light source, a modulated light source, or both. In some embodiments, light source 251 comprises at least a modulated light source configured to reduce the power consumption of access device 100. Light source 251 can be configured to produce and provide (“provide” herein) light (the “provided light” or “delivered light”, and the like, herein) that is delivered to tissue to be analyzed (“analyzed tissue AT”), and reflects from the analyzed tissue AT (“reflected light”, and the like, herein). Detector 252 can be configured to receive the reflected light, and to produce a signal based on the reflected light. Processing unit 50 can be configured to receive the signal that is based on the reflected light and to make a determination related to the tissue that reflected the light provided by light source 251. In some embodiments, detector 252 comprises a light emitting diode (LED), such as a photodiode. Detector 252 can comprise one or more optical fibers, such as an optical fiber of at least 10 microns and/or an optical fiber of no more than 200 microns, such as a 100 micron fiber.

[175] In some embodiments, access device 100 comprises a hub (e.g., hub 1011 shown and described in reference to Fig. 2 herein) and a flange (e.g., hub housing 101b also shown and described in reference to Fig. 2 herein), where access element 110, light source 251, and detector 252 are associated with the hub, and processing unit 50 (e.g., processing unit 105) is associated with the flange. In these embodiments, the hub can be detachably connected to the flange. In some embodiments, access element 110 is associated with the hub, and light source 251, detector 252, and processing unit 50 are associated with the flange.

[176] In some embodiments, light source 251 is configured to provide light comprising a wavelength of at least 568nm. Additionally, or alternatively, light source 251 can be configured to provide light comprising a wavelength of no more than 577nm. In some embodiments, light source 251 comprises one, two or more light emitting diodes (LEDs) or other light sources, that delivers light at a wavelength between: 660nm to 900nm; 610nm to 760nm; 590nm to 610nm; 570nm to 590nm; 500nm to 570nm; 485nm to 500nm; 450nm to 485nm; 370nm to 450nm; and/or 240nm to 380nm. In some embodiments, sensor assembly 200 includes a light filter (e.g., a functional element 299 comprising one, two, or more light filters) that is constructed and arranged to filter the light delivered by light source 251 (e.g., filter the delivered light to a narrower band than that delivered by source 251).

[177] In some embodiments, light source 251 comprises a light emitting diode (LED) or other light source that delivers light when activated with a drive current of approximately 250mA. The intensity of light delivered by light source 251 can be varied or pulsed (e.g., by varying or pulsing the drive current supplied to source 251). In some embodiments, light intensity is reduced or pulsed prior to entering tissue (e.g., prior to access element 110 entering tissue). In some embodiments, light intensity and/or pulsing is adjusted in a closed loop arrangement (e.g., based on light received by sensor assembly 200). In some embodiments, sensor assembly 200 comprises a first light source 251a that is driven with a first drive current level, and a second light source 251b that is driven with a second drive current level that is different than the first drive current level.

[178] In some embodiments light source 251 is configured to deliver light at two or more wavelengths, such as when delivering both deep red light (650nm - 670nm) and royal blue light (440nm - 460nm). In some embodiments, light source 251 can comprise one, two, or more light sources that are driven by one or more “lock-in” systems, such as when driven to provide one, two, or more similar and/or dissimilar patterns, intensities, durations, and/or other light delivery parameters. As described herein, functional element 299 can comprise one, two, or more light filters configured to limit the bandwidth of one or more light sources 251.

[179] In some embodiments, detector 252 is configured to produce a signal that is related to the intensity level of the reflected light (e.g., light that is reflected from tissue within the patient), and processing unit 50 can be configured to identify the tissue type that is associated with the reflected light based on the intensity of the reflected light. Additionally, or alternatively, processing unit 50 can be configured to compare the intensity of the reflected light to a reference value, and to determine the tissue type associated with the reflected light based on the comparison of the intensity of the reflected light to the reference value.

[180] In some embodiments, sensor 250 comprises one or more light directing elements, such as an optical fiber, light pipe, wire, waveguide, and/or other light-based communication filament, waveguide 253 shown. Waveguide 253 can be optically connected to light source 251 and/or to detector 252. In some embodiments, waveguide 253 can extend along at least a portion of access element 110 (e.g., to a location proximate port 119), such that the provided light from light source 251 is emitted from the distal end of waveguide 253 to the tissue proximate port 119 of access element 110 (e.g., to the tissue along path AP beyond the distal end of access element 110), and the reflected light is collected by waveguide 253 and transmitted to detector 252. In some embodiments, access element 110 includes a longitudinal channel, groove, or other recess, for example groove 1142 of shaft 114 shown. At least a portion of waveguide 253 can be located within groove 1142. In some embodiments, waveguide 253 comprises an optical fiber, such as a single optical fiber configured to both: transmit light received from light source 251 to tissue; as well as transmit light reflected from the tissue to detector 252. In some embodiments, waveguide 253 comprises two waveguides, such as a source waveguide 253 sw that is optically coupled to light source 251 and a detector waveguide 253DW that is optically coupled to detector 252. In some embodiments, source waveguide 253sw and detector waveguide 253DW are arranged in a parallel configuration, for example, when both waveguides 253 are located within groove 1142 in a parallel configuration.

[181] In some embodiments, detector 252 comprises multiple detectors, such as a first detector 252DI and a second detector 252D2, and waveguide 253 comprises multiple waveguides, such as a source waveguide 253sw, a first detector waveguide 253DWI, and a second detector waveguide 253DW2. In some embodiments, the distal end (e.g., the reflected light receiving end) of the first detector waveguide 253DWI can be located a first distance from the distal end (e.g., the light emitting end) of the source waveguide 253sw, and the distal end of the second detector waveguide 253DW2 can be located a second distance from the distal end of the source waveguide 253sw, where the first distance is greater than the second distance. In this configuration, tissue located at two different anatomical locations can be differentiated (e.g., a first location associated with the distal end of the first detector waveguide 253DWI and a second location associated with the distal end of the second detector waveguide 253DW2).

[182] Processing unit 50 can be configured to process one or more signals produced by sensor assembly 200 that relate to various properties of the provided light and/or the reflected light. For example, processing unit 50 can perform an analysis of the optical absorption of the analyzed tissue AT, the analysis based on the signal provided by sensor assembly 200.

In some embodiments, and as described herein, light source 251 (e.g., one, two, or more LEDs or other light sources) is configured to provide light comprising light at two or more wavelengths. For example, light source 251 can be configured to provide light at a first wavelength and a second wavelength, where the first wavelength is selected to enable sensor assembly 200 and processing unit 50 to detect blood based on the reflected light. A second wavelength can be selected to similarly allow detection of a non-blood tissue. Alternatively, or additionally, a second wavelength can be selected to confirm light source 251 is transmitting light (e.g., to confirm light source 251 is operating) and/or to confirm detector 252 is receiving reflected light (e.g., to confirm detector 252 is operating). For example, a second wavelength can be selected to be visible to an operator (e.g., through a portion of tissue of the patient), such as to provide a visual indicator to the operator that light source 251 is providing light to the tissue. In some embodiments, two or more wavelengths of light are provided simultaneously. Alternatively, or additionally, two or more wavelengths of light can be provided sequentially. In some embodiments, the one or more wavelengths of light provided by light source 251 can be adjustable. For example, processing unit 50 can be configured to cause the wavelength of light source 251 to be adjusted (e.g., automatically adjusted) based on a known and/or a determined location of access element 110.

[183] In some embodiments, light source 251 of sensor 250 is configured to provide light at a wavelength that is absorbed by blood but transmissive to (or reflected by) non-blood tissue. In these embodiments, sensor 250 may not include a detector, such as detector 252. For example, system 10 can be configured such that when port 119 of access element 110 is positioned outside of a blood vessel (e.g., provided light is delivered to non-blood tissue from access element 110 via port 119), the provided light is visible to the operator, and can inform the operator that port 119 of access element 110 is not located in a blood vessel.

Additionally, or alternatively, when port 119 of access element 110 is positioned within a blood vessel, at least a portion of the provided light can be absorbed by the blood, such that less of the provided light is visible to the operator (e.g., less than when positioned in non- blood tissue), and can inform the operator that port 119 of access element 110 is located in a blood vessel. In these embodiments, the operator can interpret signals provided by system 10, such that processing unit 50 is not required to determine the tissue type surrounding port 119 of access element 110.

[184] In some embodiments, sensor assembly 200 comprises two or more sensor assemblies, such as at least a first sensor assembly 200a and a second sensor assembly 200b. A first sensor assembly 200a can be configured to provide a first form of energy comprising light energy to produce a first signal based on the reflected light, and a second sensor assembly 200b can be configured to provide a second, different form of energy to produce a second signal. In some embodiments, the second form of energy can be selected from the group consisting of: ultrasound energy; electromagnetic energy, such as non-light electromagnetic energy; and/or combinations of these. In some embodiments, a second sensor assembly 200 comprises a sensor assembly configured to produce a signal related to a physiologic parameter of the patient, for example a blood pressure sensor, a respiration sensor, and/or other sensor.

[185] In some embodiments, sensor 250 of sensor assembly 200 comprises waveguide 253 comprising at least one optical fiber. Waveguide 253 can comprise a single optical fiber (e.g., a single optical fiber configured to both transmit system 10 provided light and receive reflected light) or multiple optical fibers, such as two, three, or more optical fibers. Optical fibers can comprise multimodal optical fibers, and/or can include one or more claddings or coatings. One or more optical fibers of waveguide 253 can comprise a diameter of no more than 200 microns, such as no more than 100 microns, and/or no more than 20 microns. As described herein, waveguide 253 can comprise two or more optical fibers, such as a first optical fiber that is configured to provide light from light source 251 to the tissue, and a second optical fiber that is configured to receive the reflected light and transmit the reflected light to detector 252. Alternatively, or additionally, waveguide 253 can comprise two or more optical fibers that are configured to receive the light from light source 251 and/or two or more optical fibers that are configured to receive the reflected light. In some embodiments, a first optical fiber that is configured to receive light from light source 251 can be configured to provide the light to the tissue, and a second optical fiber that is also configured to receive light source 251 can be configured to provide the light directly back to sensor assembly 200, for example directly to detector 252, such as to provide a “reference signal” that can be used to confirm the intended operation of light source 251. In some embodiments, sensor assembly 200 is configured to produce a signal related to a comparison between the reflected light and the reference signal, for example a signal related to a phase shift between the reflected light and the reference signal. In some embodiments, waveguide 253 comprises one or more optical fibers comprising circular cross-sections and/or non-circular cross-sections. [186] One, two, or more optical fibers of waveguide 253 can be adhesively and/or otherwise fixedly attached within a lumen of access element 110. Alternatively, or additionally, one, two, or more optical fibers of waveguide 253 can be adhesively and/or otherwise fixedly attached to an outer surface of access element 110. In some embodiments, one, two, or more optical fibers of waveguide 253 comprise a distal end that is positioned at a port 119 that is located at the distal end of access element 110. In some embodiments, waveguide 253 comprises one, two, or more fibers that comprise a distal end that is positioned at a port 119 that comprises a side hole of access element 110. Alternatively, or additionally, the distal end of one or more optical fibers of waveguide 253 can extend beyond port 119 (e.g., extend beyond the distal end of access element 110 and/or beyond a side hole of element 110). In some embodiments, waveguide 253 and access element 110 are manufactured using a process that include simultaneously polishing the distal end of access element 110 and the distal end of waveguide 253 (e.g., the distal ends of one or more optical fibers of waveguide 253, such that the distal end of the one or more optical fibers lies in the same plane as the distal end of element 110). [187] In some embodiments, access element 110 comprises at least a portion of sensor assembly 200 (e.g., at least a portion of sensor assembly 120). In some embodiments, shaft 114 of access element 110 includes one or more walls, wall 1143 shown, such as wall 1143 surrounding lumen 113. Lumen 113 can comprise multiple lumens, such as a first lumen 113 configured as a fluid lumen, and at least a second lumen configured to house at least a portion of sensor assembly 200, such as at least a portion of waveguide 253. For example, waveguide 253 can be positioned within a lumen 113 that extends through walls 1143 of shaft 114 (e.g., waveguide 253 can be embedded within walls 1143 of shaft 114). In some embodiments, access element 110 comprises a plastic access element (e.g., shaft 114 comprises a plastic tube), and waveguide 253 is molded (e.g., in a manufacturing process) into wall 1143 of shaft 114. In some embodiments, waveguide 253 comprises a “lighting wire” and a “detector wire”. Waveguide 253, such as a waveguide 253 comprising a lighting wire and/or a detector wire, can be embedded in and/or external to walls 1143 of shaft 114. For example, waveguide 253 can be located on an outer surface of shaft 114 (e.g., waveguide 253 can extend longitudinally along the outer surface of shaft 114). In some embodiments, waveguide 253 is secured to the outer surface of shaft 114, for example, when a tube (e.g., a heat-shrink tube) surrounds waveguide 253 and shaft 114. In some embodiments, waveguide 253 is positioned within lumen 113, for example, lumen 113 comprising a fluid lumen that is configured to deliver agent 20 to the patient. Lumen 113 can include a luminal surface, and waveguide 253 can be positioned on the luminal surface of lumen 113.

[188] In some embodiments, sensor assembly 200 comprises an ultrasound imaging assembly. Alternatively, or additionally, sensor assembly 200 can comprise an electromagnetic energy imaging assembly, for example an imaging assembly that is configured to perform an impedance measurement. In some embodiments, sensor 250 of sensor assembly 200 comprises a pressure sensor. For example, sensor 250 can comprise a pressure sensor that is located on distal portion 118 of access element 110, such that sensor 250 produces a signal that can be analyzed to determine if port 119 is positioned within a blood vessel, such as based on the identification of a blood pressure signal corresponding to an anatomical location within which access element 110 is inserted.

[189] In some embodiments, waveguide 253 comprises two or more waveguides, such as two or more waveguides each including a distal end that is configured to emit light to tissue and/or to receive reflected light from the tissue. In some embodiments, the distal end of a first waveguide 253 can be located at a first location along the length of shaft 114 (e.g., a first location proximate the distal end of shaft 114), and the distal end of a second waveguide 253 can be located at a second location along the length of shaft 114 (e.g., a second location proximal to the first location, such as near a proximal end of port 119). Processing unit 50 can be configured to process signals received from sensor assembly 200, such as a first signal related to the reflected light received from tissue proximate the distal end of the first waveguide 253 and a second signal related to the reflected light received from the tissue proximate the distal end of the second wave guide 253. Processing unit 50 can be configured to determine the position, orientation, and/or other characteristics related to the insertion of access element 110 and/or the tissue proximate port 119 based on the received signals. For example, if both the first and the second signal indicate the presence of blood, processing unit 50 can determine that port 119 is located within a blood vessel. Additionally, or alternatively, if the first signal related to the first waveguide 253 (e.g., where the distal end of the first waveguide is positioned distal to the distal end of the second waveguide 253) does not indicate the presence of blood, and the second signal received related to the second waveguide 253 does indicate the presence of blood, processing unit 50 can determine that a proximal portion of access element 110 is positioned within a blood vessel, but at least the distal portion comprising the distal end of the first waveguide 253 is positioned outside of a blood vessel (e.g., access element 110 has been inserted through a blood vessel).

[190] In some embodiments, sensor assembly 200 comprises one or more integrated circuits. For example, sensor assembly 200 can comprise sensor 250 that is configured to provide and detect reflected light, as described herein. An integrated circuit of sensor assembly 200 can comprise light source 251, detector 252, an amplifier circuit, a signal filtering circuit, and/or an optical reference arm. In some embodiments, waveguide 253 comprises a single optical fiber that is configured to optically couple to the integrated circuit comprising light source 251 and detector 252. In some embodiments, sensor assembly 200 is configured to modulate one or more transmissions that are used to produce a signal, such as a signal of sensor 250. For example, a modulated transmission of sensor assembly 200 can comprise a modulated light-based transmission. In some embodiments, sensor assembly 200 comprises a “lock-in” amplifier. In some embodiments, a lock-in amplifier is configured to only detect and/or amplify signals at a specific frequency, such as when access device 100 comprises a single waveguide 253 (e.g., a single fiber) to emit and detect light. For example, light source 251 can be configured to pulse the provided light at a first frequency, and a lock- in amplifier of sensor assembly 200 (e.g., a lock-in amplifier of detector 252) can be configured to identify signals from the reflected light occurring at the first frequency. In some embodiments, sensor assembly 200 is configured to analyze sensor signals (e.g., reflected light signals), and the lock-in amplifier is configured to eliminate noise related to ambient light (e.g., ambient light of the patient environment). In some embodiments, sensor assembly 200 is configured to analyze sensor signals (e.g., reflected light signals) using a sampling rate of at least 20Hz, such as at least 40Hz, at least 60Hz, at least 80Hz, and/or at least 100 Hz. In some embodiments, the sampling rate comprises a rate of no more than 1MHz, such as no more than 500KHz, 350KHz, or 200KHz. In some embodiments, algorithm 55 comprises a mathematical function (e.g., moving window random forest) and/or an Al algorithm, and the sensor assembly 200 sampling rate is chosen based on algorithm 55. In some embodiments, sensor assembly 200 comprises a lock-in frequency of approximately 1MHz, and sensor assembly 200 is configured to sample at a rate of lOOKHz (a 1 : 10 lock-in). [191] As described herein, access device 100 can include delivery control assembly 170. Delivery control assembly 170 can be configured to prevent and/or stop the delivery of an agent, such as agent 20 to the patient when an undesired condition is detected by the system (e.g., an undesired condition that is detected by diagnostic assembly 500, sensor assembly 200 and/or processing unit 50). In some embodiments, delivery control assembly 170 includes a biased delivery stopping mechanism, such as a spring actuated stopping mechanism and/or a magnetic stopping mechanism. Delivery control assembly 170 can be configured to automatically stop delivery of agent 20 when an undesired condition is detected. In some embodiments, delivery control assembly 170 is configured to activate alert assembly 400 when an undesired condition is detected, such that the operator can manually stop the delivery of agent 20 (e.g., stop manually depressing a syringe containing agent 20). In some embodiments, delivery control assembly 170 is configured to remove (e.g., to cause the removal of) at least a portion of agent 20 that may have been delivered to the patient (the “delivered agent”) prior to the detection of the undesired condition. For example, delivery control assembly 170 can comprise a spring-based retraction mechanism configured to remove at least a portion of the agent 20 that was delivered (e.g., delivered to the non-target location). In some embodiments, delivery control assembly 170 is configured to deliver (e.g., to automatically deliver) reversal agent 31 when an undesired condition is detected, for example, to automatically stop the delivery of agent 20, to automatically remove a portion of the delivered agent, and/or to automatically deliver reversal agent 31. In some embodiments, reversal agent 31 is delivered via access element 110. For example, lumen 113 of access element 110 can comprise a first lumen and a second lumen, where agent 20 is configured to be delivered via the first lumen, and reversal agent 31 is configured to be delivered via the second lumen. In some embodiments, the delivered agent 20 is removed via the first lumen while reversal agent 31 is simultaneously delivered via the second lumen. Reservoir 130 can include two or more reservoirs, such as a first reservoir for storing agent 20, and a second reservoir for storing reversal agent 31. In some embodiments, delivery control assembly 170 comprises a spring-based delivery mechanism that is configured to deliver reversal agent 31, for example to automatically deliver reversal agent 31 when an undesired condition is detected. Alternatively, or additionally, delivery control assembly 170 can be configured to allow an operator to manually deliver reversal agent 31. In some embodiments, reversal agent 31 comprises hyaluronidase.

[192] As described herein, access device 100 and/or sensor assembly 200 can each include a functional assembly 90, functional assemblies 190 and 290, respectively, each including at least one functional element 99, functional elements 199 and 299, respectively. Functional assembly 90 can be configured to provide light, such as light that is configured to be delivered to the patient (e.g., light delivered to perform a therapeutic function, a diagnostic function, or both). For example, light provided by functional assembly 90 can be configured to activate a medication that has been delivered to the patient (e.g., when delivered agent 20 comprises a light activated medication). Alternatively, or additionally, light provided by functional assembly 90 can be configured to promote healing of the tissue of the patient, for example to promote healing within and/or otherwise proximate the target location to which agent 20 was delivered, tissue surrounding the insertion trajectory IT, and/or the skin penetration location SP. In some embodiments, light provided by functional assembly 90 is configured to change a property of delivered agent 20. For example, agent 20 can comprise a light sensitive property selected from the group consisting of viscosity; density; color; crosslinking; and/or combinations of these.

[193] In some embodiments, functional assembly 90 is configured to deliver energy (e.g., non-light energy) to the patient. Energy delivered by functional assembly 90 can be configured to provide a function selected from the group consisting of to activate a medication; to promote healing; to change a property of agent 20, such as a physical and/or a chemical property of agent 20; to provide a catalyst for a reaction, such as a reaction between agent 20 and the tissue and/or agent 20 comprising two or more agents configured to react after injection into the patient; to enhance the absorption of agent 20 by the tissue, such as when the energy is configured to reversibly electroporate the tissue; to treat the tissue, such as by ablating the tissue (e.g., when the energy is configured to thermally ablate the tissue and/or to irreversibly electroporate the tissue); and/or combinations of these.

[194] In some embodiments, functional assembly 90 comprises an infusion pump, such as an infusion pump that is configured to continuously and/or semi-continuously inject agent 20 into the patient over a period of time. In some embodiments, system 10 is configured to turn off and/or otherwise stop or disable the delivery of agent 20 from the infusion pump if an undesired condition is detected. For example, system 10 can stop the infusion of agent 20 from the infusion pump if one or more non-target locations are detected proximate the infusion site, if an undesirable change in flow rate of agent 20 is detected, such as an undesirable increase and/or decrease in flow rate, and/or if an undesirable change in pressure is detected, such as an undesirable change in back-pressure that is experienced by the infusion pump during delivery of agent 20. Additionally, or alternatively, system 10 can be configured to alarm and/or otherwise trigger an alert, such as an alert produced by alert assembly 400 and/or an alert system of a clinical setting, such as a hospital alert system, for example when one or more non-target locations are detected proximate an infusion site of an infusion pump (e.g., a functional assembly 90 comprising an infusion pump) and/or an undesirable change in flow rate is detected.

[195] Referring now to Fig. 2, a perspective view of an embodiment of a device for accessing a target location and delivering an agent is illustrated, consistent with the present inventive concepts. Access device 100 and/or other components of system 10 described in Fig. 2 can be of similar construction and arrangement as the similar components described in reference to Fig. 1, Fig. 1 A and otherwise herein. Fig. 2 shows a syringe-based embodiment of access device 100 including access element 110 comprising a needle-like access element.

[196] Housing 101 of access device 100 can comprise two or more discrete housings, for example a first housing, syringe-body housing 101a, and a second housing, hub housing 101b, each shown. Syringe-body housing 101a can comprise a syringe-barrel-like construction, for example when housing 101a comprises reservoir 130, such that chamber 132 is defined by the walls of the housing, as shown in Fig. 2. Hub housing 101b can comprise an electronics housing, such as a housing configured to surround at least a portion of processing unit 105, user interface 106, communication module 107, sensor assembly 120, alert assembly 140, diagnostic assembly 150, power supply 160, delivery control assembly 170, functional assembly 190, and/or other electronic or other components of access device 100 (not all shown, but each described herein). As described herein, access device 100 can include one or more disposable and/or one or more reusable components, such as components that are interchangeable and used for different time periods and/or different numbers of uses. In some embodiments, syringe-body housing 101a and the related components of access device 100 comprise a disposable portion of access device 100 that is configured to be used for a first number of uses, and hub housing 101b and the related components of access device 100 comprise a reusable portion of access device 100 that is configured to be used for a second number of uses. The second number of uses can be greater than the first number of uses, for example when hub housing 101b is removable from and operably attachable to syringe-body housing 101a.

[197] In some embodiments, access element 110 includes a needle assembly, where shaft 114, including lumen 113 extending therethrough, projects distally from hub 115. Hub 115 can be configured to removably and fluidly attach access element 110 to syringe-body housing 101a, for example, such that the proximal end of lumen 113 is fluidly attached to chamber 132. In some embodiments, access element 110 and the related components of access device 100 comprise a disposable portion of access device 100 that is configured to be used for a third number of uses (e.g., related to the first number of uses of syringe-body housing 101a and/or the second number of uses of hub housing 101b). The third number of uses can comprise the least number of uses, for example when access element 110 comprises a single-use component (e.g., a component that is used for a single injection of agent 20). Access element 110 can be removable from and operably attachable to syringe-body housing 101a.

[198] In some embodiments, at least a portion of sensor assembly 120 (e.g., sensor assembly 120 comprising at least a portion of sensor assembly 200, as described herein) is located within and/or on (“associated with” herein) hub housing 101b, and/or at least a portion of sensor assembly 120 is associated with syringe-body housing 101a. Additionally, or alternatively, at least a portion of sensor assembly 120 can be associated with access element 110. In some embodiments, various components of sensor assembly 120 are associated with syringe-body housing 101a and access element 110, and the components associated with hub housing 101b are configured to provide power to sensor assembly 120, to receive signals produced by sensor assembly 120, and/or to process the received signals, such as to detect a target location and/or one or more non-target locations proximate port 119 of access element 110.

[199] In the embodiment shown in Fig. 2, sensor 125 comprises waveguide 253 (e.g., one, two, or more optical fibers) that extends along shaft 114 of access element 110, for example along an outer and/or a luminal wall, and/or within a groove or channel of shaft 114, such that the distal end of waveguide 253 (e.g., the light emitting and/or receiving portion) is positioned proximate port 119, such that signals (e.g., light) emitted from waveguide 253 are transmitted to the tissue proximate port 119, and the reflections of those signals are received by waveguide 253, such as to be transmitted back to detector 252 of sensor 125. Waveguide 253 can extend between distal portion 118 of access element 110 (e.g., between port 119 of access element 110) and light source 251 and/or detector 252 of sensor 125, as described herein.

[200] In some embodiments, syringe-body housing 101a includes a hub portion, hub 1011, that houses various components of access device 100, for example, various components that are associated with syringe-body housing 101a that are not positioned within and/or integral to reservoir 130. For example, at least a portion of sensor assembly 120 can be located within hub 1011, for example light source 251 and/or detector 252 can be located within hub 1011. Hub 1011 can include one or more connectors. For example, hub 1011 can comprise a first connector assembly, connector assembly 1012, that is configured to operably attach access element 110 to syringe-body housing 101a. Hub 1011 can include a second connector assembly, connector assembly 1013, that is configured to operably attach one or more components associated with hub housing 101b to one or more components associated with syringe-body housing 101a.

[201] In some embodiments, waveguide 253 includes a first portion, waveguide 2531 that is associated with access element 110, where the proximal portion of waveguide 2531 extends to hub 115 of access element 110. Waveguide 253 can include a second portion, waveguide 2532 that extends from the distal end of connector assembly 1012 to sensor assembly 120 located within hub 1011, for example to light source 251 and/or detector 252 (e.g., waveguide 2532 can be optically coupled to light source 251 and/or detector 252 such that waveguide 253 can transmit light between the tissue proximate port 119 of access element 110 and sensor assembly 120). In some embodiments, connector assembly 1012 is configured to connect to hub 115 to provide two or more operable connections, such as a fluid connection between chamber 132 and lumen 113 and an optical connection between waveguide 2531 and waveguide 2532. In some embodiments, connector assembly 1012 and hub 115 are configured to be connected in a single step, for example, a step including a press fitting and/or a rotation to engage the two components and to create the two or more operable connections.

[202] Access device 100 can include one or more data transmitting, power transmitting, light transmitting, fluid transmitting, or other conduits, conduit 102 shown. Conduit 102 can include one or more wires, optical fibers, tubes (e.g., tubes including one or more fluid lumens), mechanical linkages, and/or other energy-carrying conduits and/or other transmissive components. Conduit 102 can include one or more wires that transmit power and/or data between the components associated with hub housing 101b and syringe-body housing 101a and/or access element 110. For example, and as shown, conduit 102 can operably connect hub 1011 to hub housing 101b, such as to provide power from power supply 160 to sensor assembly 120, and/or to transfer data between sensor assembly 120 and processing unit 105. In some embodiments, conduit 102 is fixedly attached to hub housing 101b, and is connectable to hub 1011, such as via connector assembly 1013. For example, conduit 102 can comprise one or more connectors, such as connector 1021 that operably connects to connector assembly 1013. In some embodiments, conduit 102 is operably connectable (e.g., and removable) to either or both of hub housing 101b and hub 1011.

[203] In some embodiments, access device 100 includes plunger 133 that is slidingly received within chamber 132 of reservoir 130. Plunger 133 can be advanced to force agent 20 out of reservoir 130 (e.g., to inject agent 20 through access element 110), and/or plunger 133 can be retracted to create a low pressure within chamber 132, thus pulling material proximate access element 110 into reservoir 130 (e.g., to fill reservoir 130 with agent 20 from storage device 25, and/or to remove a portion of agent 20 that has previously been delivered to the patient, as described herein). In some embodiments, hub housing 101b is configured to physically attach to syringe-body housing 101a. For example, hub housing 101b can include one or more recesses, recess 1014 shown, that is configured to laterally receive a proximal portion of syringe-body housing 101a, such as a proximal portion including one or more projections, such as flange 1015 shown. Housings 101a, b can be configured to frictionally engage, such as to “snap-fit” together, for example when recess 1014 is constructed and arranged to “snap-fit” onto flange 1015. Hub housing 101b can include a passageway or other recess, opening 1016 shown, that slidingly receives plunger 133. In some embodiments, hub housing 101b and syringe-body housing 101a are connected during a manufacturing process, for example a process where plunger 133 is inserted through opening 1016 following the connection of housings 101a, b. Plunger 133 can be non-removable from chamber 132, such as to prevent the removal of hub housing 101b from syringe-body housing 101a (e.g., to prevent removal without breakage or other disabling of access device 100). Alternatively, or additionally, opening 1016 can comprise a lateral opening, similar to recess 1014, such that hub housing 101b can be laterally attached to syringe-body housing 101a while plunger 133 is positioned within chamber 132.

[204] Hub housing 101b can include one or more portions of user interface 106, such as one or more user output devices 62, such as an indicator light and a speaker shown, and one or more user input devices 61, such as a switch shown. In some embodiments, user input device 61 (e.g., a switch) is configured to “arm” access device 100, such as to enable sensor assembly 200, and to actively provide an output to the operator, such as via user output device 62 (e.g., a light and/or a speaker). Access device 100 can comprise a set of outputs, such as a set of outputs indicating one or more of the following: the device is armed; no tissue is detected proximate port 119 of access element 110; a target location is detected; one or more non-target locations are detected; an injection of agent 20 is in process; an injection of agent 20 has been completed; injection of agent 20 has been stopped, such as automatically stopped by delivery control assembly 170; and/or combinations of these.

[205] The above-described embodiments should be understood to serve only as illustrative examples; further embodiments are envisaged. Any feature described herein in relation to any one embodiment may be used alone, or in combination with other features described, and may also be used in combination with one or more features of any other of the embodiments, or any combination of any other of the embodiments. Furthermore, equivalents and modifications not described above may also be employed without departing from the scope of the inventive concepts, which are defined in the accompanying claims.

Claims

WHAT IS CLAIMED IS:

1. A system for accessing a target location within a patient, the system, comprising: an access device comprising: an access element comprising a port that is configured to provide access to the target location; a sensor assembly configured to produce a signal related to tissue and/or other material proximate the target location; and a processing assembly operably connected to the sensor assembly and configured to: process the signal from the sensor assembly, and perform a function selected from the group consisting of: detect and/or confirm the target location; detect and/or confirm one or more non-target locations; or detect and/or confirm the target location and detect one or more non-target locations.

2. The system according to claim 1 and/or any one or more other claims herein, further comprising an agent, wherein the system is configured to perform one, two, or more medical procedures selected from the group consisting of: collecting tissue and/or collecting other material from a location within the patient; delivering an agent to a location within the patient; implanting a device within the patient; positioning an introducer device into the patient; performing a therapeutic and/or diagnostic medical procedure where the access device provides access to a target location; and combinations thereof.

3. The system according to claim 2 and/or any one or more other claims herein, wherein the target location comprises one, two, or more locations within the patient selected from the group consisting of: a cosmetic target location; an artery; a vein; a duct; a conduit of the spine such as the epidural space and/or the intrathecal space; a bone such as a location within a bone; an organ such as the brain, the heart, the liver, the pancreas, the stomach, the bladder; the small intestine; the large intestine; a kidney, a lung, a breast, and/or other organ; a gland; and combinations thereof.

4. The system according to claim 2 and/or any one or more other claims herein, wherein the target location comprises target tissue selected from the group consisting of: tissue to be treated to improve patient cosmesis; blood; tumor tissue; abnormal tissue; tissue to be biopsied; dermal tissue; epidermal tissue; tissue of an organ; scar tissue; and combinations thereof.

5. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to avoid: undesirably delivering agent into a blood vessel; undesirably damaging a nerve; and/or undesirably damaging an organ.

6. The system according to claim 1 and/or any one or more other claims herein, further comprising an agent, wherein the system is configured to deliver the agent to the target location via the access element.

7. The system according to claim 6 and/or any one or more other claims herein, wherein the processing assembly is further configured to detect an undesired event caused by the delivery of the agent to the target location.

8. The system according to claim 7 and/or any one or more other claims herein, wherein the undesired event comprises compression of a blood vessel.

9. The system according to claim 8 and/or any one or more other claims herein, wherein the blood vessel comprises a blood vessel of an eye or other blood vessel.

10. The system according to claim 7 and/or any one or more other claims herein, wherein the undesired event comprises detection of the agent in a blood vessel.

11. The system according to claim 10 and/or any one or more other claims herein, wherein the blood vessel comprises a blood vessel of an eye or other blood vessel.

12. The system according to claim 7 and/or any one or more other claims herein, wherein the undesired event comprises damage to a nerve.

13. The system according to claim 6 and/or any one or more other claims herein, wherein the agent comprises one, two, or more agents selected from the group consisting of: a cosmetic agent; a pharmaceutical agent; a biologic agent; a chemotherapeutic agent; an anticoagulant; an analgesic; a radioisotope, such as a liquid radioisotope; an antibiotic, such as vancomycin, meropenem, and/or gentamicin; an antifungal agent, such as micafungin and/or amphotericin; a pain relief medication, such as hydromorphone and/or morphine; an antiparasitic, such as albendazole; an agent for treating low blood pressure, such as dopamine, epinephrine, norepinephrine, and/or dobutamine; an intravenous immunoglobulin medication (IVIG); a hormonal agent, such as estrogen; a steroid, such as methyl prednisone; an enzyme, such as lipase; a protein; a peptide, such as protein C concentrate; a monoclonal antibody, such as IgG; an amino acid, such as lysine; blood; plasma and/or other blood component; cells; and combinations thereof.

14. The system according to claim 6 and/or any one or more other claims herein, wherein the agent comprises a cosmesis improvement agent.

15. The system according to claim 14 and/or any one or more other claims herein, wherein the agent comprises a cosmesis improvement agent selected from the group consisting of: cosmesis improvement agent; filler; a dermal filler; hyaluronic acid; fat such as autologous fat; calcium hydroxlapatite;poly-l-lactic acid; polyalkylimide; polymethyl-methacrylate microspheres (PMMA); a neurotoxin; a plastic; platelet rich plasma (PRP); collagen; silicone; vitamins (such as vitamin C) or products derived from vitamins (such as retinoids or niacinamide); oils or lipids (such as ceramides); proteins (such as elastin) or amino acids (such as betaine); enzymes (such as lipase or hyaluronidase); organic acids (such as alpha hydroxy acids, glycolic acid or lactic acid); botanicals or plant extracts (such as aloe vera or caffeine); water and/or ice slurry; and combinations thereof.

16. The system according to claim 14 and/or any one or more other claims herein, wherein the target location comprises tissue outside of a blood vessel to which a cosmesis improvement procedure is being performed.

17. The system according to claim 16 and/or any one or more other claims herein, wherein the target location comprises tissue proximate an eye of the patient.

18. The system according to claim 16 and/or any one or more other claims herein, wherein the target location comprises a location selected from the group consisting of: the forehead; the temples; the zygoma; the anterior cheek; the lateral cheek; the medial cheek; the tear trough; the scalp; the nose; the lips; the chin; the side of the chin; Marionette lines; the nasolabial fold; the sub zygoma; the jawline; the palpebromalar groove; the jowls; the neck; platysma bands; the arms; the buttocks; the upper lip; the lower lip; the hands; the chest; the breasts; the legs; the knees; the feet; areas around the eyes; eyebrows; glabella; ears; a supraperiosteal location; scar tissue; the vaginal area; and combinations thereof.

19. The system according to claim 16 and/or any one or more other claims herein, wherein the target location comprises tissue selected from the group consisting of: dermal tissue; epidermal tissue; hypodermal tissue; subcutaneous tissue; tissue at the dermal subcutaneous junction; muscle; fat; and combinations thereof.

20. The system according to claim 6 and/or any one or more other claims herein, wherein the agent comprises a treatment agent.

21. The system according to claim 20 and/or any one or more other claims herein, wherein the target location comprises a blood vessel, and wherein the treatment agent is delivered systemically via the access element.

22. The system according to claim 21 and/or any one or more other claims herein, wherein the treatment agent comprises an agent selected from the group consisting of: a pharmaceutical agent; a chemotherapeutic agent; an antibiotic; an anticoagulant; an analgesic; a radioisotope; and combinations thereof.

23. The system according to claim 20 and/or any one or more other claims herein, wherein the treatment agent comprises a chemotherapeutic, a liquid radioisotope, or both.

24. The system according to claim 23 and/or any one or more other claims herein, wherein the target location comprises tumor tissue.

25. The system according to claim 20 and/or any one or more other claims herein, wherein the treatment agent comprises a sclerotherapy agent.

26. The system according to claim 25 and/or any one or more other claims herein, wherein the target location comprises a vein of the patient.

27. The system according to claim 6 and/or any one or more other claims herein, wherein the agent comprises a material selected from the group consisting of: blood; plasma or other blood component; cells; and combinations thereof.

28. The system according to claim 6 and/or any one or more other claims herein, wherein the agent comprises an agent storage device.

29. The system according to claim 28 and/or any one or more other claims herein, wherein the access device further comprises a reservoir for storing the agent, and wherein the agent storage device is configured to transfer the agent from the agent storage device into the reservoir.

30. The system according to claim 6 and/or any one or more other claims herein, wherein the processing assembly is configured to detect the one or more non-target locations, and wherein the system is configured to avoid delivery of the agent into the one or more non-target locations.

31. The system according to claim 30 and/or any one or more other claims herein, wherein the one or more non-target locations comprises a blood vessel.

32. The system according to claim 6 and/or any one or more other claims herein, wherein the agent comprises an additive.

33. The system according to claim 32 and/or any one or more other claims herein, wherein the additive is configured reduce pain and/or to reduce bleeding.

34. The system according to claim 32 and/or any one or more other claims herein, wherein the additive comprises epinephrine and/or an analgesic such as lidocaine.

35. The system according to claim 6 and/or any one or more other claims herein, wherein the agent includes beads configured to reduce migration of the agent.

36. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to remove a body substance from the target location via the access element.

37. The system according to claim 36 and/or any one or more other claims herein, wherein the body substance comprises blood.

38. The system according to claim 36 and/or any one or more other claims herein, wherein the body substance comprises a substance selected from the group consisting of: blood; fat; connective tissue; muscle; lymphatic fluid; dermal tissue; tumor tissue, such as tumor tissue from the skin or other parts of the body; marrow; and combinations of thereof.

39. The system according to claim 36 and/or any one or more other claims herein, wherein the processing assembly is configured to detect the one or more non-target locations and wherein the system is configured to avoid removal of a body substance from the one or more non-target locations.

40. The system according to claim 1 and/or any one or more other claims herein, wherein the access device comprises at least a portion of the processing assembly.

41. The system according to claim 1 and/or any one or more other claims herein, further comprising a console that operably attaches to the access device, and wherein the console comprises at least a portion of the processing assembly.

42. The system according to claim 1 and/or any one or more other claims herein, wherein the processing assembly is configured to detect the target location.

43. The system according to claim 42 and/or any one or more other claims herein, wherein the target location comprises a location outside of a blood vessel.

44. The system according to claim 43 and/or any one or more other claims herein, wherein the processing assembly is further configured to detect the one or more non-target locations, and wherein the one or more non-target locations comprises a blood vessel location and/or a nerve location.

45. The system according to claim 42 and/or any one or more other claims herein, wherein the target location comprises a blood vessel lumen.

46. The system according to claim 45 and/or any one or more other claims herein, further comprising an agent to be delivered to the blood vessel lumen via the access element.

47. The system according to claim 46 and/or any one or more other claims herein, wherein the agent comprises a medication.

48. The system according to claim 45 and/or any one or more other claims herein, wherein the access element is configured to remove blood, deliver blood, or both.

49. The system according to claim 42 and/or any one or more other claims herein, wherein the target location comprises epidural space and/or intrathecal space.

50. The system according to claim 49 and/or any one or more other claims herein, further comprising an agent comprising an analgesic, wherein the system is configured to deliver the analgesic to the epidural space and/or intrathecal space via the access element.

51. The system according to claim 42 and/or any one or more other claims herein, wherein the target location comprises tumor tissue.

52. The system according to claim 51 and/or any one or more other claims herein, wherein the system further comprises an agent comprising: a chemotherapeutic; a liquid radioisotope; or both, and wherein the system is configured to deliver the agent to the tumor tissue via the access element.

53. The system according to claim 42 and/or any one or more other claims herein, wherein the processing assembly is further configured to detect the one or more non-target locations.

54. The system according to claim 53 and/or any one or more other claims herein, wherein the target location comprises a location outside of a blood vessel, and wherein the one or more non-target locations comprises a blood vessel location.

55. The system according to claim 1 and/or any one or more other claims herein, wherein the processing assembly is configured to detect the one or more nontarget locations.

56. The system according to claim 55 and/or any one or more other claims herein, wherein the one or more non-target locations comprise a blood vessel location.

57. The system according to claim 56 and/or any one or more other claims herein, further comprising an agent comprising a cosmesis improvement agent or other agent, wherein the system is configured to deliver the agent to tissue outside of a blood vessel.

58. The system according to claim 57 and/or any one or more other claims herein, wherein the target location comprises tissue proximate an eye of the patient.

59. The system according to claim 55 and/or any one or more other claims herein, wherein the one or more non-target locations comprise a location outside of a blood vessel.

60. The system according to claim 55 and/or any one or more other claims herein, wherein the processing assembly is further configured to detect the target location.

61. The system according to claim 60 and/or any one or more other claims herein, wherein the one or more non-target locations comprise a blood vessel location and wherein the target location comprises a location outside of a blood vessel.

62. The system according to claim 60 and/or any one or more other claims herein, wherein the one or more non-target locations comprise one or more nerves, and wherein the target location comprises a location within 20mm or 10mm of the one or more nerves.

63. The system according to claim 1 and/or any one or more other claims herein, wherein the processing assembly is further configured to detect inflammation of tissue, such as blood vessel tissue and/or other tissue.

64. The system according to claim 63 and/or any one or more other claims herein, wherein the processing assembly detects the inflammation based on increased blood flow.

65. The system according to claim 63 and/or any one or more other claims herein, wherein the processing assembly detects the inflammation based on redness of the tissue.

66. The system according to claim 63 and/or any one or more other claims herein, wherein the processing assembly detects the inflammation based on spectral properties of the tissue.

67. The system according to claim 63 and/or any one or more other claims herein, wherein the tissue comprises the tissue of a blood vessel.

68. The system according to claim 1 and/or any one or more other claims herein, wherein the access device is configured to provide access to the target location via the access element.

69. The system according to claim 68 and/or any one or more other claims herein, wherein the access provided by the access device comprises fluid access of the target location.

70. The system according to claim 1 and/or any one or more other claims herein, wherein the access device is configured to, via the access element: deliver a material to the target location; remove a body substance from the target location; or both.

71. The system according to claim 1 and/or any one or more other claims herein, wherein the access device comprises a reservoir for storing a material.

72. The system according to claim 71 and/or any one or more other claims herein, wherein the system comprises multiple reservoirs.

73. The system according to claim 71 and/or any one or more other claims herein, wherein the reservoir comprises a fillable and/or refillable reservoir.

74. The system according to claim 1 and/or any one or more other claims herein, wherein the access device further comprises an alert assembly, and wherein the access device is configured to activate the alert assembly when the port of the access element is within a pre-determined distance of the target location and/or the one or more non-target locations.

75. The system according to claim 74 and/or any one or more other claims herein, wherein the alert assembly is configured to modulate, change in tone or volume, or otherwise modify a provided alert as the proximity to the target location and/or non-target location changes.

76. The system according to claim 74 and/or any one or more other claims herein, wherein the one or more non-target locations comprise a blood vessel.

77. The system according to claim 1 and/or any one or more other claims herein, wherein the access device is configured to be calibrated.

78. The system according to claim 1 and/or any one or more other claims herein, wherein the access element is coupled to a syringe barrel containing an agent, wherein the syringe barrel has a plunger disposed therein, and wherein movement of the plunger into the barrel forces the agent through a distal tip of the access element and into an internal location within the patient.

79. The system according to claim 1 and/or any one or more other claims herein, wherein the access element is coupled to a syringe barrel with a plunger disposed therein, and wherein the plunger is withdrawn to draw fluid from the patient through the access element.

80. The system according to claim 1 and/or any one or more other claims herein, wherein the access element is configured to penetrate the patient’s skin.

81. The system according to claim 1 and/or any one or more other claims herein, wherein the access element is configured to provide access to the target location for a time period of at least 1 hour.

82. The system according to claim 81 and/or any one or more other claims herein, wherein the access element is configured to provide access to the target location for a time period of at least 3 days.

83. The system according to claim 81 and/or any other claim herein, wherein the access element is configured to provide access to the target location for a time period of at least 1 week.

84. The system according to claim 81 and/or any one or more other claims herein, wherein the access element is configured to provide access to the target location for a time period of at least 1 month.

85. The system according to claim 1 and/or any one or more other claims herein, wherein the access element comprises a needle or other filament with a size of at least 32 gauge, a size of no more than 6 gauge, or both.

86. The system according to claim 85 and/or any one or more other claims herein, wherein the access element comprises a needle or other filament of 27 gauge.

87. The system according to claim 85 and/or any one or more other claims herein, wherein the access element comprises a needle or other filament with a size of at least 30 gauge, a size of no more than 23 gauge, or both.

88. The system according to claim 1 and/or any one or more other claims herein, wherein the access element comprises multiple access elements.

89. The system according to claim 88 and/or any one or more other claims herein, wherein a first access element and a second access element comprise different properties.

90. The system according to claim 89 and/or any one or more other claims herein, wherein the different properties comprise: different diameters; different lengths; different materials of construction; and/or different levels of rigidity.

91. The system according to claim 1 and/or any one or more other claims herein, wherein the access element comprises a needle.

92. The system according to claim 1 and/or any one or more other claims herein, wherein the access element comprises a cannula.

93. The system according to claim 92 and/or any one or more other claims herein, wherein the access element further comprises a needle positioned within the cannula.

94. The system according to claim 1 and/or any one or more other claims herein, wherein the access element comprises a trocar.

95. The system according to claim 1 and/or any one or more other claims herein, wherein the access element comprises a laparoscopic port.

96. The system according to claim 1 and/or any one or more other claims herein, wherein the access element comprises an introducer.

97. The system according to claim 1 and/or any one or more other claims herein, wherein the access element comprises a glass filament.

98. The system according to claim 97 and/or any one or more other claims herein, wherein the glass filament comprises a glass needle.

99. The system according to claim 1 and/or any one or more other claims herein, wherein the access element comprises a filament with two or more lumens.

100. The system according to claim 99 and/or any one or more other claims herein, wherein the two or more lumens comprise staggered distal ends.

101. The system according to claim 1 and/or any one or more other claims herein, wherein the access element comprises a hub.

102. The system according to claim 101 and/or any one or more other claims herein, wherein the hub comprises a diameter of no more than 30mm, 25mm, and/or 20mm.

103. The system according to claim 1 and/or any one or more other claims herein, wherein the access element comprises a coating.

104. The system according to claim 103 and/or any one or more other claims herein, wherein the coating comprises a coating selected from the group consisting of: a lubricious coating; a hydrophilic coating; a hydrophobic coating; an ultrasonically reflective coating; a radiopaque coating; a conductive coating, such as an electrically and/or thermally conductive coating; a magnetic coating; and combinations thereof.

105. The system according to claim 1 and/or any one or more other claims herein, wherein the access device comprises at least a portion of the sensor assembly.

106. The system according to claim 105 and/or any one or more other claims herein, wherein the access device comprises all of the sensor assembly.

107. The system according to claim 1 and/or any one or more other claims herein, further comprising a console, and wherein the console comprises at least a portion of the sensor assembly.

108. The system according to claim 1 and/or any one or more other claims herein, wherein the sensor assembly is configured to determine if the target location and/or the one or more non-target locations are in the advancement pathway of the access element.

109. The system according to claim 1 and/or any one or more other claims herein, wherein the sensor assembly comprises: a light source configured to deliver light to tissue within the patient to generate reflected light; and a detector configured to detect the reflected light.

110. The system according to claim 109 and/or any one or more other claims herein, wherein the light source comprises a static light source, a modulated light source, or both.

111. The system according to claim 110 and/or any one or more other claims herein, wherein the light source comprises a modulated light source configured to reduce power consumption of the access device.

112. The system according to claim 109 and/or any one or more other claims herein, wherein the detector comprises a photodiode detector.

113. The system according to claim 109 and/or any one or more other claims herein, wherein the detector comprises an optical fiber of no more than 200 microns and/or of no less than 10 microns, such as a 100 micron fiber.

114. The system according to claim 109 and/or any one or more other claims herein, wherein the access device further comprises a hub and a flange, wherein the access element, the light source, and the detector are associated with the hub, and wherein the processing assembly is associated with the flange.

115. The system according to claim 114 and/or any one or more other claims herein, wherein the hub is detachably connected to the flange.

116. The system according to claim 109 and/or any one or more other claims herein, wherein the access device further comprises a hub and a flange, wherein the access element is associated with the hub, and wherein the light source, the detector, and the processing assembly are associated with the flange

117. The system according to claim 116 and/or any one or more other claims herein, wherein the hub is detachably connected to the flange.

118. The system according to claim 109 and/or any one or more other claims herein, wherein the light source has a wavelength of at least 568nm, a wavelength of no more than 577nm, or both.

119. The system according to claim 109 and/or any one or more other claims herein, wherein the processing assembly is configured to: determine an intensity level of the reflected light from tissue within the patient; and identify the tissue type associated with the reflected light based on determining the intensity level of the reflected light from the tissue.

120. The system according to claim 119 and/or any one or more other claims herein, wherein the processing assembly, when determining an intensity level of the reflected light from the tissue, is further configured to: compare the intensity level of the reflected light to a reference value, and identify the tissue type associated with the reflected light based on comparing the intensity level of the reflected light to the reference value.

121. The system according to claim 109 and/or any one or more other claims herein, further comprising a detector waveguide associated with the access element and optically connected to the detector, wherein the waveguide is configured to transmit the reflected light to the detector.

122. The system according to claim 121 and/or any one or more other claims herein, wherein the access element comprises a longitudinal groove, and wherein the detector waveguide is disposed within the longitudinal groove.

123. The system according to claim 121 and/or any one or more other claims herein, wherein the access element comprises a longitudinal channel within the access element, and wherein the detector waveguide is disposed within the longitudinal channel.

124. The system according to claim 121 and/or any one or more other claims herein, wherein the detector waveguide comprises an optical fiber.

125. The system according to claim 121 and/or any one or more other claims herein, further comprising a source waveguide associated with the access element and optically connected to the light source, wherein the source waveguide is configured to transmit light from the light source.

126. The system according to claim 125 and/or any one or more other claims herein, wherein the access element comprises a longitudinal groove, and wherein the source waveguide is disposed within the longitudinal groove.

127. The system according to claim 125 and/or any one or more other claims herein, wherein the access element comprises a longitudinal channel within the access element, and wherein the source waveguide is disposed within the longitudinal channel.

128. The system according to claim 125 and/or any one or more other claims herein, wherein the detector waveguide is adjacent to the source waveguide.

129. The system according to claim 125 and/or any one or more other claims herein, wherein the detector waveguide is a first detector waveguide and wherein the detector is a first detector, the access device further comprising: a second detector waveguide associated with the access element and optically coupled to a second detector, wherein the second detector waveguide is configured to transmit the reflected light to the second detector, and wherein the second detector waveguide is closer to the source waveguide than the first detector waveguide.

130. The system according to claim 125 and/or any one or more other claims herein, wherein the source waveguide comprises an optical fiber.

131. The system according to claim 109 and/or any one or more other claims herein, wherein the processing assembly is configured to perform an analysis of optical absorption based on the signal produced by the sensor assembly.

132. The system according to claim 109 and/or any one or more other claims herein, wherein the light source is configured to produce light with a wavelength between 568nm and 577nm.

133. The system according to claim 109 and/or any one or more other claims herein, wherein the light source is configured to produce light with a wavelength of 13 lOnm.

134. The system according to claim 109 and/or any one or more other claims herein, wherein the light source is configured to produce light with a wavelength between lOOnm and 1800nm.

135. The system according to claim 109 and/or any one or more other claims herein, wherein the light source is configured to produce light at two or more wavelengths.

136. The system according to claim 135 and/or any other claim herein, wherein a first wavelength is selected to detect blood.

137. The system according to claim 136 and/or any one or more other claims herein, wherein a second wavelength is selected to detect a non-blood form of tissue.

138. The system according to claim 136 and/or any one or more other claims herein, wherein a second wavelength is configured to confirm the light source is transmitting light and/or to confirm that the detector is receiving reflected light.

139. The system according to claim 135 and/or any one or more other claims herein, wherein the two or more wavelengths of light are delivered simultaneously.

140. The system according to claim 135 and/or any one or more other claims herein, wherein the two or more wavelengths of light are delivered sequentially.

141. The system according to claim 109 and/or any one or more other claims herein, wherein the light source is configured to adjust the wavelength of light delivered.

142. The system according to claim 141 and/or any one or more other claims herein, wherein the light source is configured to adjust the wavelength based on a known and/or determined location of the access element.

143. The system according to claim 109 and/or any one or more other claims herein, wherein the sensor assembly comprises a first sensor assembly and a second sensor assembly.

144. The system according to claim 143 and/or any one or more other claims herein, wherein the first sensor assembly delivers light to produce a first signal based on the reflected light, and the second sensor assembly delivers another form of energy to produce a second signal.

145. The system according to claim 144 and/or any one or more other claims herein, wherein the another form of energy comprises ultrasound energy, electromagnetic energy, or both.

146. The system according to claim 143 and/or any one or more other claims herein, wherein the second sensor assembly comprises a blood pressure sensor and/or a respiration sensor.

147. The system according to claim 109 and/or any one or more other claims herein, wherein the sensor assembly comprises at least one optical fiber.

148. The system according to claim 147 and/or any one or more other claims herein, wherein the at least one optical fiber comprises a multimodal optical fiber.

149. The system according to claim 147 and/or any one or more other claims herein, wherein the at least one optical fiber comprises a cladding.

150. The system according to claim 147 and/or any one or more other claims herein, wherein the at least one optical fiber comprises a coating.

151. The system according to claim 147 and/or any one or more other claims herein, wherein the at least one optical fiber comprises a single optical fiber.

152. The system according to claim 147 and/or any one or more other claims herein, wherein the at least one optical fiber comprises a first optical fiber configured to transmit light received from the light source and a second optical fiber configured to transmit the reflected light to the detector.

153. The system according to claim 147 and/or any one or more other claims herein, wherein the at least one optical fiber comprises three optical fibers.

154. The system according to claim 147 and/or any one or more other claims herein, wherein the at least one optical fiber comprises an optical fiber of at least 10 microns, an optical fiber of no more than 200 microns, and/or a 100 micron optical fiber.

155. The system according to claim 147 and/or any one or more other claims herein, wherein the at least one optical fiber comprises an optical fiber with a circular cross section.

156. The system according to claim 147 and/or any one or more other claims herein, wherein the at least one optical fiber comprises an optical fiber with a non-circular cross section.

157. The system according to claim 147 and/or any one or more other claims herein, wherein the access element comprises a distal end, and wherein the at least one optical fiber comprises a distal end that is positioned at the distal end of the access element.

158. The system according to claim 147 and/or any one or more other claims herein, wherein the access element comprises a distal end, and wherein the at least one optical fiber comprises a distal end that extends beyond the distal end of the access element.

159. The system according to claim 147 and/or any one or more other claims herein, wherein the access element comprises a distal end, and wherein the access device is manufactured using a process that includes simultaneously polishing the distal end of the access element and a distal end of the at least one optical fiber.

160. The system according to claim 147 and/or any one or more other claims herein, wherein the at least one optical fiber comprises a first optical fiber, a second optical fiber, and a third optical fiber, wherein the first optical fiber is configured to transmit light received from the light source to the tissue, the second optical fiber is configured to transmit a reference signal comprising light received from the light source to the detector, and the third optical fiber is configured to transmit the reflected light to the detector.

161. The system according to claim 147 and/or any one or more other claims herein, wherein the sensor assembly is configured to produce a signal related to a phase shift between the reference signal and the reflected light.

162. The system according to claim 1 and/or any one or more other claims herein, wherein the access element comprises a wall defining a conduit, a lighting wire, and a detector wire.

163. The system according to claim 162 and/or any one or more other claims herein, wherein the lighting wire and/or the detector wire are embedded in the wall of the access element.

164. The system according to claim 162 and/or any one or more other claims herein, wherein the lighting wire and/or the detector wire are located: external to the wall of the access element; and/or within a lumen of the access element.

165. The system according to claim 1 and/or any one or more other claims herein, wherein the sensor assembly comprises an ultrasound imaging assembly.

166. The system according to claim 1 and/or any one or more other claims herein, wherein the sensor assembly comprises an electromagnetic energy imaging assembly.

167. The system according to claim 166 and/or any one or more other claims herein, wherein the sensor assembly is configured to perform an impedance measurement.

168. The system according to claim 1 and/or any one or more other claims herein, wherein the sensor assembly comprises a pressure sensor.

169. The system according to claim 168 and/or any one or more other claims herein, wherein the pressure sensor is positioned on the distal portion of the access element and is configured to determine if the port of the access element is within a blood vessel based on identification of a blood pressure signal corresponding to an anatomical location in which the access element is inserted.

170. The system according to claim 1 and/or any one or more other claims herein, wherein the sensor assembly comprises an integrated circuit.

171. The system according to claim 170 and/or any one or more other claims herein, wherein the integrated circuit comprises a light source, a light sensor, and a reference arm.

172. The system according to claim 171 and/or any one or more other claims herein, further comprising a single optical fiber that optically connects to the integrated circuit.

173. The system according to claim 1 and/or any one or more other claims herein, wherein the access element and/or other portion of the access device comprises at least a portion of the sensor assembly.

174. The system according to claim 173 and/or any one or more other claims herein, wherein the at least a portion of the sensor assembly comprises a communication filament selected from the group consisting of an optical fiber; a light pipe; a wire; a waveguide; and combinations thereof.

175. The system according to claim 174 and/or any one or more other claims herein, wherein the access element comprises an outer surface, and wherein the communication filament is positioned on the outer surface of the access element.

176. The system according to claim 175 and/or any one or more other claims herein, further comprising a heat shrink tube or other tube that surrounds and secures the communication filament to the access element.

177. The system according to claim 174 and/or any one or more other claims herein, wherein the access element comprises a lumen, and wherein the communication filament is positioned within the lumen of the access element.

178. The system according to claim 177 and/or any one or more other claims herein, wherein the access element comprises a luminal inner surface, and wherein the communication filament is positioned on the inner luminal surface of the access element.

179. The system according to claim 174 and/or any one or more other claims herein, wherein the access element comprises a wall, and wherein the communication filament is positioned within the wall of the access element.

180. The system according to claim 179 and/or any one or more other claims herein, wherein the access element comprises a plastic tube, and wherein the communication filament is molded in the wall of the access element.

181. The system according to claim 174 and/or any one or more other claims herein, wherein the access element comprises an elongate channel, and wherein the communication filament is positioned in the elongate channel.

182. The system according to claim 173 and/or any one or more other claims herein, wherein the at least a portion of the sensor assembly comprises an optical fiber.

183. The system according to claim 1 and/or any one or more other claims herein, wherein the sensor assembly modulates a transmission used to produce the signal of the sensor assembly.

184. The system according to claim 183 and/or any one or more other claims herein, wherein the modulated transmission comprises a modulated lightbased transmission.

185. The system according to claim 1 and/or any one or more other claims herein, wherein the sensor assembly is configured to deliver light from the port and/or from the distal portion of the access element.

186. The system according to claim 185 and/or any one or more other claims herein, wherein the sensor assembly is configured to deliver light that is absorbed by blood but transmissive in non-blood tissue.

187. The system according to claim 1 and/or any one or more other claims herein, wherein the sensor assembly comprises a lock-in amplifier.

188. The system according to claim 1 and/or any one or more other claims herein, wherein the access device further comprises a power supply.

189. The system according to claim 188 and/or any one or more other claims herein, wherein the power supply comprises a battery, a capacitor, or both.

190. The system according to claim 188 and/or any one or more other claims herein, wherein the power supply comprises a rechargeable power supply.

191. The system according to claim 188 and/or any one or more other claims herein, wherein the power supply stores sufficient energy for an access procedure of up to 90 minutes.

192. The system according to claim 188 and/or any one or more other claims herein, wherein the power supply comprises a volume of no more than 2500mm³, 2000mm³, and/or 1500mm³.

193. The system according to claim 1 and/or any one or more other claims herein, wherein the access device comprises a diagnostic assembly.

194. The system according to claim 193 and/or any one or more other claims herein, wherein the diagnostic assembly is configured to detect one or more failure modes of the access device.

195. The system according to claim 194 and/or any one or more other claims herein, wherein the one or more failure modes comprises improper insertion of the access element into the target location.

196. The system according to claim 195 and/or any one or more other claims herein, wherein the target location comprises a venous access site comprising a vessel of the patient.

197. The system according to claim 196 and/or any one or more other claims herein, wherein the improper insertion comprises penetration of both sides of the vessel.

198. The system according to claim 196 and/or any one or more other claims herein, wherein the one or more failure modes comprises the loss of vascular access.

199. The system according to claim 1 and/or any one or more other claims herein, wherein the access device comprises a delivery control assembly.

200. The system according to claim 199 and/or any one or more other claims herein, further comprising an agent to be delivered to the target location by the access element, wherein the delivery control assembly is configured to stop delivery of the agent to the target site when an undesired condition is detected by the system.

201. The system according to claim 200 and/or any one or more other claims herein, wherein the delivery control assembly comprises a spring-based stopping mechanism.

202. The system according to claim 200 and/or any one or more other claims herein, wherein the delivery control assembly comprises a magnetic-based stopping mechanism.

203. The system according to claim 200 and/or any one or more other claims herein, wherein the sensor assembly is configured to detect the undesired condition.

204. The system according to claim 200 and/or any one or more other claims herein, wherein the delivery control assembly is configured to automatically stop the delivery of the agent.

205. The system according to claim 200 and/or any one or more other claims herein, further comprising an alert assembly, wherein the delivery control assembly is configured to activate the alert assembly when the undesired condition is detected, such that an operator can stop the delivery of the agent.

206. The system according to claim 200 and/or any one or more other claims herein, wherein the delivery control assembly is further configured to remove from the patient at least a portion of the agent that has been delivered to the patient prior to the detection of the undesired condition.

207. The system according to claim 200 and/or any one or more other claims herein, wherein the delivery control assembly is configured to remove from the patient at least a portion of the agent that has been delivered to the patient.

208. The system according to claim 207 and/or any one or more other claims herein, wherein the delivery control assembly comprises a spring-based retraction mechanism configured to remove the at least a portion of the agent.

209. The system according to claim 200 and/or any one or more other claims herein, further comprising a reversal agent configured to reduce effects of an agent delivered to the patient, wherein the delivery control assembly is configured to deliver the reversal agent when the undesired condition is detected.

210. The system according to claim 209 and/or any one or more other claims herein, wherein the reversal agent is delivered via the access element.

211. The system according to claim 210 and/or any one or more other claims herein, wherein the access element comprises a first lumen for delivering the agent and a second lumen for delivering the reversal agent.

212. The system according to claim 209 and/or any one or more other claims herein, wherein the access device comprises a reservoir for storing the reversal agent.

213. The system according to claim 209 and/or any one or more other claims herein, wherein the delivery control assembly comprises a spring-based delivery mechanism configured to deliver the reversal agent.

214. The system according to claim 209 and/or any one or more other claims herein, wherein the delivery control assembly is configured to automatically deliver the reversal agent.

215. The system according to claim 209 and/or any one or more other claims herein, wherein the delivery control assembly is configured to allow an operator to manually deliver the reversal agent.

216. The system according to claim 209 and/or any one or more other claims herein, wherein the reversal agent comprises hyaluronidase.

217. The system according to claim 1 and/or any one or more other claims herein, wherein the access device comprises a disposable portion and a reusable portion.

218. The system according to claim 217 and/or any one or more other claims herein, wherein the reusable portion comprises at least a portion of the sensor assembly.

219. The system according to claim 217 and/or any one or more other claims herein, wherein the reusable portion comprises a sterilizable portion of the access device.

220. The system according to claim 1 and/or any one or more other claims herein, wherein the access device comprises a functional assembly.

221. The system according to claim 220 and/or any one or more other claims herein, wherein the sensor assembly comprises a functional assembly.

222. The system according to claim 220 and/or any one or more other claims herein, wherein the functional assembly is configured to deliver light.

223. The system according to claim 222 and/or any one or more other claims herein, wherein the delivered light is configured to activate a medication administered to the patient.

224. The system according to claim 223 and/or any one or more other claims herein, wherein the access element is configured to deliver the medication to the patient.

225. The system according to claim 222 and/or any one or more other claims herein, wherein the delivered light is configured to promote healing of tissue of the patient.

226. The system according to claim 225 and/or any one or more other claims herein, wherein the delivered light is configured to promote healing of tissue within and/or otherwise proximate the target location.

227. The system according to claim 222 and/or any one or more other claims herein, further comprising an agent to be delivered to the target tissue via the access element, wherein the delivered light is configured to change a property of the delivered agent.

228. The system according to claim 227 and/or any one or more other claims herein, wherein the delivered light is configured to change a property of the agent selected from the group consisting of viscosity; density; color; crosslinking; and combinations thereof.

229. The system according to claim 220 and/or any one or more other claims herein, wherein the functional assembly is configured to deliver energy.

230. The system according to claim 229 and/or any one or more other claims herein, wherein the delivered energy is configured to provide a function selected from the group consisting of to activate a medication; to promote healing; to change a property of the agent; to change a physical property of the agent; to change a chemical property of the agent; to provide a catalyst for a reaction; to enhance the absorption of the agent by tissue; to reversibly electroporate tissue; to treat tissue; to ablate tissue; to thermally ablate tissue; to irreversibly electroporate tissue; and combinations thereof.

231. The system according to claim 1 and/or any one or more other claims herein, wherein the access device further comprises a use detection assembly.

232. The system according to claim 231 and/or any one or more other claims herein, wherein the use detection assembly is configured to detect each advancement of the access element through the skin surface of the patient.

233. The system according to claim 1 and/or any one or more other claims herein, wherein the access device comprises a functional element.

234. The system according to claim 233 and/or any one or more other claims herein, wherein the functional element comprises one or more transducers.

235. The system according to claim 233 and/or any one or more other claims herein, wherein the functional element comprises one or more sensors.

236. The system according to claim 233 and/or any one or more other claims herein, wherein the functional element comprises one or more accelerometers or other motion-detecting sensors configured to produce a signal.

237. The system according to claim 236 and/or any one or more other claims herein, wherein the system is configured to analyze the signal from the one or more accelerometers and/or other motiondetecting sensors to determine the speed, acceleration, location, and/or orientation of the access device.

238. The system according to claim 1 and/or any one or more other claims herein, further comprising an alert assembly configured to provide an alert.

239. The system according to claim 238 and/or any one or more other claims herein, wherein the alert assembly is configured to indicate the detection of the target location being proximate the port of the access element.

240. The system according to claim 239 and/or any one or more other claims herein, wherein the alert assembly is further configured to indicate the detection of the non-target location proximate the port of the access element.

241. The system according to claim 238 and/or any one or more other claims herein, wherein the alert assembly is further configured to indicate the detection of the non-target location proximate the port of the access element.

242. The system according to claim 238 and/or any one or more other claims herein, wherein the alert assembly is configured to provide a visual alert, an audible alert, and/or a tactile alert.

243. The system according to claim 242 and/or any one or more other claims herein, wherein the alert assembly is configured to provide two or more of: a visual alert, an audible alert, and/or a tactile alert.

244. The system according to claim 238 and/or any one or more other claims herein, wherein the access device comprises the alert assembly.

245. The system according to claim 238 and/or any one or more other claims herein, further comprising an operator device, wherein the operator device comprises the alert assembly.

246. The system according to claim 1 and/or any one or more other claims herein, further comprising a processing unit comprising a processor and a memory storage element coupled to the processor, wherein the memory storage element stores instructions for the processor to perform an algorithm.

247. The system according to claim 246 and/or any one or more other claims herein, wherein the processing assembly is configured to analyze the signal from the sensor assembly.

248. The system according to claim 246 and/or any one or more other claims herein, wherein the access device comprises the processing assembly.

249. The system according to claim 246 and/or any one or more other claims herein, wherein the algorithm comprises an Al algorithm.

250. The system according to claim 246 and/or any one or more other claims herein, wherein the sensor assembly comprises a first sensor assembly configured to produce a first signal and a second sensor assembly configured to produce a second signal, and wherein the algorithm receives the first signal and the second signal and detects the target location and/or detects the non-target location based on an analysis of the first signal and the second signal.

251. The system according to claim 246 and/or any one or more other claims herein, wherein the algorithm comprises a bias.

252. The system according to claim 251 and/or any one or more other claims herein, wherein the sensor assembly comprises a first sensor assembly configured to produce a first signal and a second sensor assembly configured to produce a second signal, and wherein the algorithm receives the first signal and the second signal and detects the target location and/or detects the non-target location based on an analysis of the first signal, the second signal, and the bias.

253. The system according to claim 246 and/or any one or more other claims herein, wherein the algorithm comprises a hysteresis-based algorithm.

254. The system according to claim 246 and/or any one or more other claims herein, wherein algorithm is configured to adjust the sensor assembly to account for patient-to-patient variability.

255. The system according to claim 246 and/or any one or more other claims herein, wherein the algorithm is configured to differentiate a first tissue type from a second tissue type.

256. The system according to claim 255 and/or any one or more other claims herein, wherein the first tissue type comprises healthy tissue and the second tissue type comprises diseased tissue.

257. The system according to claim 256 and/or any one or more other claims herein, wherein the diseased tissue comprises malignant tissue.

258. The system according to claim 246 and/or any one or more other claims herein, wherein the algorithm is configured to perform a compensation routine.

259. The system according to claim 258 and/or any one or more other claims herein, wherein the compensation routine is configured to compensate for one or more foreign substances present in blood and/or other tissue.

260. The system according to claim 259 and/or any one or more other claims herein, wherein the one or more foreign substances comprise at least a chemotherapeutic.

261. The system according to claim 259 and/or any one or more other claims herein, wherein the one or more foreign substances comprise a substance selected from the group consisting of an antibiotic, such as vancomycin, meropenem, and/or gentamicin; an antifungal medication, such as micafungin and/or amphotericin; a pain relief medication, such as hydromorphone and/or morphine; an agent for treating low blood pressure, such as dopamine, epinephrine, norepinephrine, and/or dobutamine; an intravenous immunoglobulin medication (IVIG); and combinations thereof.

262. The system according to claim 259 and/or any one or more other claims herein, wherein the one or more foreign substances comprise the agent.

263. The system according to claim 1 and/or any one or more other claims herein, wherein the sensor assembly is configured to produce a first signal and a second signal, and wherein the first signal is related to tissue proximate the distal end of the access element, and the second signal is related to tissue proximate a proximal portion of the access element.

264. The system according to claim 263 and/or any one or more other claims herein, wherein the algorithm determines the location of the access element based on analysis of the first and second signals.

265. The system according to claim 263 and/or any one or more other claims herein, wherein the algorithm determines if the access element is positioned within a blood vessel based on analysis of the first signal and the second signal.

266. The system according to claim 263 and/or any one or more other claims herein, wherein the algorithm determines if the access element has been inserted through a blood vessel based on analysis of the first signal and the second signal.

267. The system according to claim 1 and/or any one or more other claims herein, further comprising a secondary agent.

268. The system according to claim 1 and/or any one or more other claims herein, further comprising a functional assembly.

269. The system according to claim 268 and/or any other claim herein, wherein the functional assembly comprises an infusion pump.

270. The system according to claim 269 and/or any one or more other claims herein, wherein the system is configured to turn off the infusion pump if the non-target location is detected by the system.

271. The system according to claim 269 and/or any one or more other claims herein, wherein the system is configured to provide an alarm if an undesirable condition is detected by the system.

272. The system according to claim 271 and/or any one or more other claims herein, wherein the system is operably connected to an alarm system of a clinical setting, and the provided alarm is provided by the alarm system.

273. The system according to claim 271 and/or any one or more other claims herein, wherein the undesirable condition comprises an undesirable change in flow rate.

274. The system according to claim 271 and/or any one or more other claims herein, wherein the undesirable condition comprises an undesirable change in pressure.

275. The system according to claim 1 and/or any one or more other claims herein, further comprising a functional element.

276. The system according to claim 1 and/or any one or more other claims herein, further comprising a console configured to operably connect to the access device.

277. The system according to claim 276 and/or any one or more other claims herein, wherein the console is configured to operably connect to the access device via a wired connection.

278. The system according to claim 276 and/or any one or more other claims herein, wherein the console is configured to operably connect to the access device via a wireless connection.

279. The system according to claim 276 and/or any one or more other claims herein, wherein the console comprises an IOT module.

280. The system according to claim 276 and/or any one or more other claims herein, wherein the console is configured to upload data from the access device.

281. The system according to claim 280 and/or any one or more other claims herein, wherein the console is configured to adjust operation of the access device via an analysis of the uploaded data.

282. The system according to claim 280 and/or any one or more other claims herein, wherein the data comprises data selected from the group consisting of serial number data; model number data; date of manufacture data; usage data; fault data; battery status data; and combinations thereof.

283. The system according to claim 280 and/or any one or more other claims herein, wherein the data comprises data related to the number of times presence of blood was detected by the system during a procedure.

284. The system according to claim 276 and/or any one or more other claims herein, wherein the console is configured to upload data selected from the group consisting of patient data; procedural data; access device data; clinician data; environmental data; temporal data; and combinations thereof.

285. The system according to claim 276 and/or any one or more other claims herein, wherein the console comprises a barcode reader and/or other data reader configured to record barcode or other data sources of the access device.

286. The system according to claim 1 and/or any one or more other claims herein, further comprising a server configured to communicate with the access device over a network.

287. The system according to claim 286 and/or any one or more other claims herein, further comprising one or more consoles configured to operably connect with the access device, wherein the access device comprises multiple access devices, and wherein the server is configured to communicate with the one or more consoles and/or the multiple access devices.

288. The system according to claim 287 and/or any one or more other claims herein, wherein the server is configured to collect usage information.

289. The system according to claim 288 and/or any one or more other claims herein, wherein the processing assembly comprises an Al algorithm, and wherein the system is configured to train the Al algorithm based on the collected use information.

290. The system according to claim 1 and/or any one or more other claims herein, further comprising an operator device.

291. The system according to claim 290 and/or any one or more other claims herein, wherein the operator device is configured to alert the operator when a system alarm is encountered.

292. The system according to claim 290 and/or any one or more other claims herein, wherein the operator device comprises a device selected from the group consisting of watch; smart watch; wrist-worn device; cell phone; smart phone; tablet computer; a haptic alert device, such as a device comprising a vibrational transducer; audio alert device; and combinations thereof.

293. The system according to claim 290 and/or any one or more other claims herein, wherein the operator device is configured to remotely control the access device and/or other component of the system.

294. The system according to claim 290 and/or any one or more other claims herein, wherein the operator device is operably attached to the access device and/or other component of the system.

295. The system according to claim 294 and/or any one or more other claims herein, wherein the operator device is operably attached to the access device and/or other component of the system via a wireless connection.

296. A method of accessing a target location, comprising: selecting the system according to one or more claims herein; accessing a target location; delivering an agent and/or removing a body substance from the target location.