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WO2025240864A1 - Dispositif médical électro-adhésif pour récupération de tissu - Google Patents

Dispositif médical électro-adhésif pour récupération de tissu

Info

Publication number
WO2025240864A1
WO2025240864A1 PCT/US2025/029769 US2025029769W WO2025240864A1 WO 2025240864 A1 WO2025240864 A1 WO 2025240864A1 US 2025029769 W US2025029769 W US 2025029769W WO 2025240864 A1 WO2025240864 A1 WO 2025240864A1
Authority
WO
WIPO (PCT)
Prior art keywords
biopsy
tissue
instrument
needle
electro
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/029769
Other languages
English (en)
Inventor
Kester Julian Batchelor
Uwe Fischer
Tsuyoshi Hayashida
Tsunetaka Akagane
Theodore C. BLUS
Kazuya Nakabe
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Olympus Corp of the Americas
Original Assignee
Olympus Corp of the Americas
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Olympus Corp of the Americas filed Critical Olympus Corp of the Americas
Publication of WO2025240864A1 publication Critical patent/WO2025240864A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/04—Endoscopic instruments, e.g. catheter-type instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00002—Operational features of endoscopes
    • A61B1/00004—Operational features of endoscopes characterised by electronic signal processing
    • A61B1/00009—Operational features of endoscopes characterised by electronic signal processing of image signals during a use of endoscope
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00066—Proximal part of endoscope body, e.g. handles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00131—Accessories for endoscopes
    • A61B1/00137—End pieces at either end of the endoscope, e.g. caps, seals or forceps plugs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A61B1/018—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor for receiving instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/04—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances
    • A61B1/05—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances characterised by the image sensor, e.g. camera, being in the distal end portion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/06—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements
    • A61B1/0661—Endoscope light sources
    • A61B1/0676—Endoscope light sources at distal tip of an endoscope
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/06—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements
    • A61B1/0661—Endoscope light sources
    • A61B1/0684—Endoscope light sources using light emitting diodes [LED]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3478—Endoscopic needles, e.g. for infusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Clinical applications
    • A61B8/0833—Clinical applications involving detecting or locating foreign bodies or organic structures
    • A61B8/0841—Clinical applications involving detecting or locating foreign bodies or organic structures for locating instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Clinical applications
    • A61B8/0833—Clinical applications involving detecting or locating foreign bodies or organic structures
    • A61B8/085—Clinical applications involving detecting or locating foreign bodies or organic structures for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/267—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the respiratory tract, e.g. laryngoscopes, bronchoscopes
    • A61B1/2676—Bronchoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/04—Endoscopic instruments, e.g. catheter-type instruments
    • A61B2010/045—Needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A61B2017/3413—Needle locating or guiding means guided by ultrasound
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/42—Details of probe positioning or probe attachment to the patient
    • A61B8/4272—Details of probe positioning or probe attachment to the patient involving the acoustic interface between the transducer and the tissue
    • A61B8/4281—Details of probe positioning or probe attachment to the patient involving the acoustic interface between the transducer and the tissue characterised by sound-transmitting media or devices for coupling the transducer to the tissue

Definitions

  • the present disclosure relates generally, but not by way of limitation, to medical devices comprising elongate bodies configured to be inserted into incisions or openings in anatomy of a patient to provide diagnostic or treatment operations.
  • the present disclosure relates to medical devices that can be inserted into anatomy of a patient to perform a biological matter retrieval process, such as to remove sample tissue for analysis.
  • Typical diagnostic procedures involve obtaining biopsy tissue at a site of interest where target tissue resides within the anatomy of a patient. Sometimes, the target tissue resides deep within the anatomy within circuitous passageways. In the case of lungs, lung cancer can be difficult to diagnose due to the difficulties in accessing airways near areas of interest. Areas of interest can present as lung nodules, small tissue masses in the lung that can be in the range of approximately five millimeters to approximately twenty-five millimeters, for example. It is desirable to biopsy these lung nodules to ascertain whether the tissue therein is cancerous or otherwise diseased.
  • Typical lung cancer biopsy devices involve the use of a biopsy needle with a bronchoscope.
  • Existing systems can be constrained by difficulties in accessing lung nodules, especially in the smaller peripheral airways that may be too narrow to accommodate larger biopsy systems.
  • biopsy needles are typically straight and relatively inflexible, though they can be gently curved to be positioned through the nose or mouth, the throat, through the voice box (larynx), and into the trachea (windpipe) before reaching the lungs.
  • the rigidity of the biopsy needle can limit the articulation of the bronchoscope, and it can be difficult to pass the biopsy needle through a working channel of a bronchoscope when the bronchoscope is articulated around a tight corner.
  • the material of the needle may inelastically yield, which can result in a bent needle that is difficult to control.
  • straight biopsy needles obtain samples along an axis of the needle through back and forth cycling of the needle.
  • obtaining multiple samples from different regions of a single nodule, for example can be difficult and can require repeated repositioning of the bronchoscope or guide sheath, for example.
  • problems associated with lung biopsy procedures can include the difficulty in retrieving an adequate size of tissue samples in constrained locations without causing irritation to the patient and damage to the collected sample.
  • a biopsy device e.g., a needle
  • a small-diameter device channel e.g., working channel
  • the bronchoscope can include imaging capabilities to guide the bronchoscope to desired anatomic locations and to guide the biopsy device to specific tissues of interest, e.g., tissue to be biopsied.
  • a tip of the biopsy device is brought to the lesion to be biopsied, where tissue is collected with the tip of the device, such as by piercing a needle into the tissue.
  • the bronchi repeatedly branch and their diameter decreases, making it difficult for the physician to access the lesion and to obtain a sufficient amount of tissue for genetic testing.
  • cryo-biopsy systems involve the use of a cryoprobe to freeze a tissue sample.
  • the cryoprobe can be guided to the target tissue with a bronchoscope.
  • the cryoprobe can receive a stream of cold cryo-fluid from a cryo-fluid system and return the cry oprobe to the cryo-fluid system after use, e.g., freezing of tissue.
  • cryo-biopsy systems can achieve better results than biopsy needles, such as by preserving the sample tissue in a better form for analyzing.
  • cryo-biopsy systems can suffer from poor versatility and high costs.
  • cryo-biopsy systems using biopsy needles can have other drawbacks, including a) bleeding, especially when creating a tissue passage or hole by needle and pulling the tissue sample therethrough, b) lack of durability of the biopsy needle, c) lack of being able to access lesions, especially in the peripheral areas of lungs, which typically requires that a scope be able to make deep angulations, and d) potential for degradation of the tissue sample quality from the process of applying cryogenic freezing to the tissue sample. Further description of potential issues with cryo-biopsy systems are discussed with reference to FIG. 1 through FIG. 6.
  • the present disclosure can provide solutions to these problems and other problems, such as by providing biopsy systems that utilize electrical phenomena to cause coupling or attaching, e.g., attraction or adhesion, of one mass to another mass, as well as the reversal of such coupling or attaching.
  • the electrical phenomena can be used to cause tissue to couple to a biopsy instrument.
  • the present disclosure can be used in conjunction with other types of medical devices and instruments, such as other instruments that can be inserted into or otherwise engaged with tissue to perform interventional or diagnostic capabilities, such a forceps and the like.
  • the application of an electric field can induce electron transfer between two items to induce electrostatic attraction. This can be similar to the phenomena that occurs when a piece of paper clings to a glass surface in the presence of electrical surface charges.
  • the electrostatic effect of astriction between two surfaces subjected to an electric field can be used to attract tissue to a biopsy instrument.
  • Electrostatic adhesion can utilize chemical bonds that are established between items when atoms are shared in a molecule, the forces of which are described in Xu et al. (ACS Cent. Sci. 2024,10,695-707).
  • the application of an electric field can induce atom sharing between two items to induce electrostatic adhesion. This can be similar to the phenomena that has recently been discussed in literature with respect to the attachment of gel to metal bodies via chemical bond induced by an electric field.
  • the electrostatic effect of astriction between two surfaces subjected to an electric polarity can be used to adhere tissue to a biopsy instrument.
  • the electrical phenomena of electro-attraction and/or electro-adhesion can be used to couple or attach tissue, at least temporarily, to an instrument for the collection of biopsy material.
  • electrical phenomena can be utilized with a biopsy needle, as discussed with reference to FIG. 8 through FIG. 12.
  • electrical phenomena can be utilized with an electrode, as discussed with reference to FIG. 13 A to FIG. 19.
  • the present application may also or alternatively be used with electro-attraction, in select implementations.
  • electro-adhesion With regard to electro-adhesion, it has recently been demonstrated that electricity can be used to adhere gels, or gel-like objects such as tissue, to objects, particularly hard objects, such as metals and graphite. It was found that salt content in soft materials can play a role in the electro-adhesive effect. Further, metals that are more likely to release free electrons demonstrate a higher likelihood of adhering to the soft tissue under an applied electro-adhesive field. Metals like copper, lead, and tin readily release electrons and exhibit better electro-adhesion compared to metals like nickel, iron, zinc, and titanium, which hold onto their electrons more strongly. The research indicates that electro-adhesion may occur due to chemical bonds formed between the electrode and soft material after electron exchange.
  • Electro-adhesion can occur at different electrodes (e.g., anode or cathode) depending on the materials involved, and increasing voltage strength and duration typically enhances adhesion strength.
  • application of an electric field in a first polarity can induce adhesion and application of an electric filed in the opposite polarity can remove the adhesion.
  • the present disclosure recognizes that such electro-adherence can be applied to biological tissue in medical procedures.
  • the present disclosure relates to biopsy devices that can utilize electro-adhesion to separate, e.g., tear, and retrieve, e.g., pull, tissue from within the anatomy of a patient in order to perform a biopsy or for other purposes.
  • electro-adhesive biopsy devices can be particularly useful in lung cancer biopsy procedures where accessibility is an issue.
  • EABDs can use a gel, such as acrylamide gel, as the electro-adhesive material, applying it to biological tissue through electrodes to collect lung tissue samples.
  • gel may not be used, and tissue is directly adhered to the electrode, e.g., biopsy needle.
  • a first polarity can be applied to the tissue (and gel, if present) to cause the tissue to attach to the electrode.
  • the tissue (and gel, if present) can be detached from the electrode, allowing for safe and efficient sample retrieval. Without wishing to be bound by theory, it is thought that the gel may be able to promote electroadhesion.
  • access to the target tissue for the biopsy tissue can be achieved via mechanical cutting, slicing or piercing of tissue, such as with a needle, blade or the like. Thereafter, electro-adhesion can be used to bond the target tissue to the mechanical cutting instrument, e.g., needle.
  • access to the target tissue for the biopsy tissue can be achieved via electrical cutting, slicing or piercing of tissue, such as with an electrode electrically activated to achieve ablation, cauterization, coagulation and the like.
  • the electrical cutting instrument can comprise a mechanical cutting instrument, e.g., needle, or a shaped cutting device, e.g., a pointed cutting probe.
  • EABDs of the present disclosure can apply radiofrequency (RF) technology to activate an electrode to perform cutting to access the target tissue.
  • RF radiofrequency
  • existing RF technology such as monopolar and bi-polar cutting, can be used to perform the cutting and the electro-adhesion, thereby reducing the cost of the EABD.
  • electrical energy can be applied to selectively adhere and detach target tissue to the biopsy device, such as after electrical cutting has been performed to reach the target tissue.
  • a biopsy probe can comprise a sheath comprising an internal lumen, a biopsy instrument extending within the sheath, the biopsy instrument comprising a head configured to pierce tissue, and a controller configured to control application of electrical energy to the biopsy instrument.
  • a system for obtaining a biopsy sample can comprise a biopsy probe comprising an elongate insertion shaft and a biopsy instrument extending from a distal end portion of the elongate insertion shaft, and an electrical generator configured to at a first time, apply a first voltage to the biopsy instrument at a first polarity to cause adhesion of a tissue sample to the biopsy instrument and at a second time subsequent to the first time, apply a second voltage to the biopsy instrument at a second polarity to cause detachment of the tissue sample to the biopsy instrument.
  • a method of adhering tissue to a medical instrument during a biopsy procedure can comprise inserting the medical instrument into an anatomic location to reach target tissue, applying a first voltage having a first polarity to the medical instrument to cause electro-adhesion of at least a portion of the target tissue to the medical instrument, and withdrawing the medical instrument from the anatomic location to pull the portion of the target tissue from the anatomic location.
  • FIG. l is a schematic diagram of a cryogenic biopsy system illustrating an endobronchial ultrasound scope and a biopsy needle.
  • FIG. 2 is a schematic diagram of a cryogenic biopsy procedure showing a biopsy needle being repeatedly advanced to cause bleeding.
  • FIG. 5 is a schematic diagram of a cryogenic biopsy procedure showing collapse of a tissue sample due to freezing and melting.
  • FIG. 7A is a schematic diagram of an endoscopy system comprising an imaging and control system and an endoscope with which electro-cutting and electro-adherence features of the present disclosure can be used.
  • FIG. 7B is a schematic diagram of the imaging and control system of FIG. 1 showing the endoscope connected to various capabilities of the imaging and control system.
  • FIG. 7C is a schematic diagram of an electro-surgical system having an electrical generator system configured to apply electrical cutting energy and electro-adhesion energy to an electrode.
  • FIG. 7D is a schematic diagram of an electro-adhesive biopsy device of the present disclosure that can be used for lung cancer biopsy procedures.
  • FIG. 8 is a schematic diagram of an electro-adhesive biopsy procedure showing an electro-adhesive biopsy needle extending from an endobronchial ultrasound scope and into anatomy proximate target tissue.
  • FIG. 9 is a schematic diagram of the electro-adhesive biopsy procedure of FIG. 8 showing biopsy gel being injected into target tissue.
  • FIG. 10 is a schematic diagram of the electro-adhesive biopsy procedure of FIG. 9 showing a voltage being applied to the target tissue from the biopsy needle.
  • FIG. 11 is a schematic diagram of the electro-adhesive biopsy procedure of FIG.
  • FIG. 12 is a schematic diagram of the biopsy needle of FIG. 11 with collected target tissue inserted into a container of saline.
  • FIG. 13 A is a perspective view of a cutting electrode that can be used as an electro-adhesive biopsy device.
  • FIG. 13B is a schematic cross-sectional view of the cutting electrode of FIG. 13 A showing lead wires connected to electrodes and a non-stick coating.
  • FIG. 14 is a perspective view of the cutting electrode of FIG. 13A showing tissue adhered to the cutting electrode.
  • FIG. 15 is a schematic diagram of an electro-adhesive biopsy procedure showing an electro-adhesive biopsy electrode extending from an endobronchial ultrasound scope in the line of site of target tissue.
  • FIG. 16 is a schematic diagram of the electro-adhesive biopsy procedure of FIG.
  • FIG. 17 is a schematic diagram of the electro-adhesive biopsy procedure of FIG.
  • FIG. 18 is a schematic diagram of the electro-adhesive biopsy procedure of FIG.
  • FIG. 19 is a schematic diagram of the electro-adhesive biopsy procedure of FIG.
  • FIG. 20 is an illustration of different electro-adhesion tip designs suitable for use with the electro-adhesion biopsy devices of the present disclosure.
  • FIG. 21 is an illustration of an electro-adhesion tip used in conjunction with a sheath to inhibit or prevent a collected tissue sample from being dislodged from an electroadhesion biopsy tip during retrieval.
  • FIG. 22 is a block diagram illustrating operations in methods of obtaining a tissue sample using an electro-adhesion biopsy needle.
  • FIG. 23 is a block diagram illustrating operations in methods of obtaining a tissue sample using an electro-adhesion biopsy probe.
  • FIG. 1 is a schematic diagram of a comparative cryogenic biopsy system 10 illustrating endobronchial ultrasound scope 12 and biopsy needle 14.
  • Endobronchial ultrasound scope 12 can comprise shaft 16, tip 18, sensor 20 and lumen 22.
  • Biopsy needle 14 can comprise shaft 24 and tip 26.
  • Endobronchial ultrasound scope 12 can be inserted into anatomic duct 28 having duct wall 30.
  • Lesion 32 can be located within matter of duct wall 30.
  • Biopsy needle 14 can extend from lumen 22 in shaft 16 to project toward and into duct wall 30.
  • Biopsy needle 14 can be advanced to form tissue passage 34A, which can, under suitable circumstances, extend along a trajectory toward lesion 32.
  • Biopsy needle 14 can include internal passages to receive cold cryo-fluid and return used cryo-fluid.
  • FIG. 1 through FIG. 6 illustrate steps involved in cryogenic biopsy procedures, with each step highlighting a challenge in cryo-biopsy.
  • issues with cryo-biopsy can include difficulty in handling bleeding (FIG. 2), needle damage (FIG. 3), accessing the lesion (FIG. 4), collapse of target tissue (FIG. 5), difficulty in retrieving tissue samples back through tissue channels formed by cryo-biopsy needle (FIG. 6) and high cost.
  • FIG. 2 is a schematic diagram of a cryogenic biopsy procedure showing biopsy needle 14 being repeatedly advanced to cause bleeding, indicated by droplets 35.
  • Biopsy needle 14 can be aimed at lesion 32, such as by positioning of endobronchial ultrasound scope 12. Thereafter, biopsy needle 14 can be advanced into duct wall 30 via piercing action to obtain a tissue sample of lesion 32. If biopsy needle 14 is started along a trajectory that does not intersect lesion 32, biopsy needle 14 can be retracted along the same trajectory and repositioned to a new trajectory. Thus, there can be a tendency to repeatedly advance and retract biopsy needle 14 in the same position, due to technical difficulties or the desire to collect additional tissue, for example.
  • Advancement of biopsy needle 14, particular repeated advancement and retraction, can lead to bleeding and the formation of droplets 35. Furthermore, repeated piercing of biopsy needle 14 can potentially lead to pneumothorax, i.e., lung collapse, in extreme cases. Bleeding can range from mild, which can be manageable with suction, to severe, which can potentially require surgical intervention or lead to significant respiratory instability.
  • the present disclosure can address problems related to piercing of a biopsy needle into tissue, such as bleeding, by using electrosurgical energy to cut tissue, which has the benefit of simultaneously or alternatively cauterizing the tissue to inhibit or eliminate bleeding.
  • the concepts of the present disclosure can facilitate access to lesions in the peripheral areas, where small areas sometimes lead to repeated stabbing of the biopsy needle to gain the desired access to the target tissue.
  • the present disclosure can allow for easier hemostasis, e.g., limiting or stopping of bleeding, by using an electrode which has not only biopsy functionality but also Coagulation Mode, thereby also reducing the risk of thoracotomy.
  • FIG. 3 is a schematic diagram of a cryogenic biopsy procedure showing bending of biopsy needle 14.
  • forward or distal force can be applied to biopsy needle 14 to cause biopsy needle 14 to penetrate into the tissue of lesion 32.
  • Continued applied forward force can cause shaft 24 to bend at the exit of lumen 22 at location 36.
  • the bending of shaft 24 can inhibit transmission of additional force to lesion 32. That is, additional forward axial force applied to the portion of shaft 24 within lumen 22 will not cause additional forward movement of biopsy needle 14 toward lesion 32, but will cause further bending or kinking of shaft 24.
  • a user may have to reposition biopsy needle into another passage 34B to reach cavity 38 to retrieve a sample.
  • a 1.1 millimeter diameter cryo-biopsy probe offers good flexibility and easy navigation through tight spaces compared to larger counterparts.
  • small-diameter probes have limitations, such as reaching highly angular parts of the lung or where highly accurate placement of the biopsy probe is critical.
  • the smaller size and increased flexibility can sometimes compromise the control and stability needed in these delicate areas, such as when a sharp bend or kink occurs within the probe.
  • the present disclosure can address these problems by using electrosurgical energy to cut a path to an area of interest within anatomy, thereby reducing the resistance applied to a biopsy probe in reaching target tissue such as lesion 32 and also reducing the likelihood of kinking occurring. With the present disclosure, there is no need to repeatedly puncture the affected area with a needle.
  • FIG. 4 is a schematic diagram of a cryogenic biopsy procedure showing difficulty in bending biopsy needle 14.
  • Some embodiments of cryo-biopsy devices can utilize hard portions that make the devices difficult to bend.
  • a tip of a cryo-probe can be hard due to the inclusion of tubing for cryogenic gases.
  • endobronchial ultrasound scope 12 it can be difficult to bend endobronchial ultrasound scope 12 to aim biopsy needle 14 along a desired trajectory to reach lesion 32.
  • repeated punctures can be needed to perforate the bronchus with biopsy needle 14 to facilitate the passage of a cryo-probe or needle, each time applying significant tension to the path of biopsy needle 14.
  • certain EBUS (Endobronchial Ultrasound) devices can break in the middle of the needle under certain circumstances.
  • the present disclosure can address these problems by using electrosurgical energy to cut a path to an area of interest within anatomy, thereby reducing the resistance applied to a biopsy probe in reaching target tissue such as lesion 32.
  • the tips of the devices of the present disclosure are not rigid since cryo-fluid tubing is not needed. Tips of the devices of the present disclosure can be made flexible all the way to the tip allowing for a sufficient bending angle when combined with a scope.
  • FIG. 5 is a schematic diagram of a cryogenic biopsy procedure showing collapse of tissue due to freezing and melting.
  • cryogenic energy can be applied to lesion 32 by biopsy needle 14.
  • the cryogenic freezing of lesion 32 can cause the lesion to collapse and shrink in size to tissue sample 40.
  • An artifact can comprise nontissue structures that can interfere with diagnosis, and can arise from cell damage being crushed during the extraction process. The procedure might not always yield adequate tissue for a definitive diagnosis, especially in cases requiring extensive histopathological evaluation.
  • the present disclosure can address these problems by using electro-adhesion to cause large volumes of tissue to adhere to the biopsy probe.
  • samples suitable for pathology can be obtained from small lesions in the peripheral regions of the lung without causing damage.
  • bonding action of electro-adhesion, with or without gel it is possible to obtain tissue from precisely targeted areas. It is particularly important to preserve the biological integrity of the tissue sample to ensure the highest chances of correctly assessing the tissue sample.
  • FIG. 6 is a schematic diagram of a cryogenic biopsy procedure showing tissue sample 40 being larger than tissue passage 34A formed by biopsy needle 14. Despite shrinkage from the size of lesion 32, tissue sample 40 can be larger than tissue passage 34 A formed by biopsy needle 14. Thus, as a user retracts biopsy needle 14 into endobronchial ultrasound scope 12, difficulties can arise in the retrieval of tissue sample 40. For example, tissue sample 40 can be pushed off biopsy needle 14 by engagement with shaft 16 around lumen 22.
  • the present disclosure can address these problems by using electro-adhesion to cause the tissue sample to bond to the biopsy probe, thereby resisting being pushed off of the probe by withdrawal through the passage formed by the biopsy probe.
  • the electro-adhesion effect can retain the tissue sample all the way until the tissue sample is withdrawn from the body.
  • Electrodes can be used for electrosurgery, e.g., cutting and coagulating, as well as for electro-adhesion.
  • electrosurgery e.g., cutting and coagulating
  • electro-adhesion e.g., electro-adhesion
  • FIG. 7A is a schematic diagram of endoscopy system 100 that can include control system 102, parent medical device 104 and child medical device 108.
  • Child medical device 108 can be attachable to parent medical device 104 and can include distal end 110 that can extend from distal end 109 of parent medical device 104 via a distal working channel port, e.g., working channel 112.
  • the system of FIG. 1 is an illustrative example of an endoscopy system suitable for use with the systems, devices, and methods described herein.
  • endoscopy system 100 can include electro-surgical and electro-adhesive capabilities described herein.
  • distal end 110 of child medical device 108 and distal end 109 of parent medical device 104 can include or function as electrodes to facilitate application of electrical energy to tissue to facilitate or enable electro-surgical energy, e.g., to cause cutting, cauterization and coagulation of tissue, and/or adhesion energy, e.g., to cause bonding of tissue to one or both of parent medical device 104 and child medical device 108.
  • Parent medical device 104 can be insertable into an anatomical region for imaging, such as to identify potential lesions for biopsy.
  • One or more sampling devices, e.g., child medical device 108 can be tethered to parent medical device 104 for sampling or treating tissue identified by parent medical device 104.
  • Parent medical device 104 can interface or connect to control system 102.
  • Parent medical device 104 is described in the present disclosure as a bronchoscope, though other types of endoscopes are contemplated for use with the features and teachings of the present disclosure, such as gastroscopes, colonoscopes, cystoscopes, hysteroscopes, gynoscopes and laparoscopes.
  • Child medical device 108 can is described in the present disclosure as a biopsy needle, though other types of instruments are contemplated for use with the features and teachings of the present disclosure, such as forceps, snares, baskets and scissors.
  • Control system 102 can include control unit 114, display unit 116, input unit 118, light source 120, fluid source 122, and suction pump 124.
  • Control system 102 can include various ports for coupling with endoscopy system 100.
  • control unit 114 can include a data input/output port for receiving data from and communicating data to parent medical device 104, such as from ultrasound sensor 149.
  • Light source 120 can include an output port for transmitting light to parent medical device 104, such as via a fiber optic link.
  • Fluid source 122 can include a port for transmitting fluid to parent medical device 104.
  • Fluid source 122 can include, for example, a pump and a fluid tank or can be connected to an external tank, vessel, or storage unit.
  • Suction pump 124 can include a port to draw a vacuum from parent medical device 104 to generate suction, such as for withdrawing fluid from the anatomical region into which parent medical device 104 is inserted.
  • Display unit 116 and input unit 118 can be used by an operator of endoscopy system 100 to control functions of endoscopy system 100 and view output of parent medical device 104.
  • Control unit 114 can also generate signals or other outputs from treating the anatomical region into which parent medical device 104 is inserted.
  • control unit 114 can generate electrical output, acoustic output, fluid output, or the like for treating the anatomical region with, for example, cauterizing, cutting, freezing, or the like.
  • control unit 114 can be configured to output electrical signals, such as radio frequency signals, monopolar energy, bipolar energy and the like.
  • Parent medical device 104 can include insertion section 126, functional section 128 and handle section 130, which can be coupled to cable section 132 and coupler section 134. Insertion section 126 can extend distally from handle section 130, and cable section 132 can extend proximally from handle section 130. Insertion section 126 can be elongated and include a bending section and a distal end to which functional section 128 can be attached. The bending section can be controllable (e.g., by steering control 136 on handle section 130) to maneuver the distal end through tortuous anatomical passageways (e.g., stomach, duodenum, kidney, ureter, trachea, lungs, or the like).
  • tortuous anatomical passageways e.g., stomach, duodenum, kidney, ureter, trachea, lungs, or the like.
  • Insertion section 126 can also include one or more working channels, e.g., working channel 112, that can be elongated and can support the insertion of one or more therapeutic tools of functional section 128, such as child medical device 108.
  • the working channel can extend between handle section 130 and functional section 128.
  • Additional functionalities, such as fluid passages, guide wires, and pull wires, can also be provided by insertion section 126 (e.g., via suction or irrigation passageways, or the like).
  • steering control 136 can be used to push and pull steering wires extending to functional section 128 to cause upward or downward bending of the distal portion of insertion section 126 and/or functional section 128.
  • Coupler section 134 can be connected to control unit 114 to connect parent medical device 104 to multiple features of control unit 114, such as input unit 118, light source 120, fluid source 122, suction pump 124, and an electrical generator, such as treatment generator 164 (FIG. 7B).
  • Handle section 130 can include steering control 136 and port 138.
  • Steering control 136 can be a knob, lever, or other actuation mechanism or the like, which can be used to navigate parent medical device 104 within the patient.
  • Steering control 136 can be connected to a pull wire or other actuation mechanisms, extending through insertion section 126.
  • One or more of port 138, port 140 and other ports can be configured to couple various electrical cables, guide wires, auxiliary scopes, tissue collection devices, fluid tubes, and the like to handle section 130, such as for coupling with insertion section 126.
  • Port 140 can be configured to receive child medical device 108 and guide child medical device 108 to working channel 112.
  • control system 102 can be provided on a mobile platform (e.g., cart 142) with shelves for housing of light source 120, suction pump 124, image processing unit 162 (FIG. 2), or the like.
  • a mobile platform e.g., cart 142 with shelves for housing of light source 120, suction pump 124, image processing unit 162 (FIG. 2), or the like.
  • components of control system 102, shown in FIG. 1 and FIG. 2 can be provided directly on parent medical device 104 to make the endoscope “self-contained.”
  • Functional section 128 can include components for treating and diagnosing the anatomy of a patient.
  • Functional section 128 can include imaging device 144 (e.g., a complementary metal oxide semiconductor (CMOS) based, Chip-on-the-Tip image sensor; a charge-coupled device (“CCD” sensor); an ultrasound transducer), illumination device 146 (e.g., a light emitting diode or a distal end of a light conductor connected to light source 120), and working channel 112 at a distal face of functional section 128.
  • imaging device 144 e.g., a complementary metal oxide semiconductor (CMOS) based, Chip-on-the-Tip image sensor; a charge-coupled device (“CCD” sensor); an ultrasound transducer
  • illumination device 146 e.g., a light emitting diode or a distal end of a light conductor connected to light source 120
  • working channel 112 at a distal face of functional section 128.
  • functional section 128 can comprise ultrasound sensor
  • child medical device 108 can extend from working channel 112 at the distal face of functional section 128 of parent medical device 104.
  • Child medical device 108 can be configured to be attached to port 140 at coupler 147.
  • Child medical device 108 can extend into and through working channel 112 within insertion section 126 and extend out of working channel 112 of parent medical device 104.
  • Child medical device 108 can comprise sheath 154 and needle 156. Child medical device 108 can include sheath extension mechanism 148 and instrument actuator 150.
  • Sheath extension mechanism 148 can be configured to move sheath 154 relative to coupler 147.
  • Sheath extension mechanism 148 can comprise a knob or slider on housing 152 of child medical device 108 for advancing or retracting sheath 154 within working channel 112 so as to control how far distally from working channel 112 that sheath 154 extends.
  • Sheath extension mechanism 148 can thus be configured to extend sheath 154 of child medical device 108 beyond a distal end of parent medical device 104, such as to navigate child medical device 108 to the target area within the patient.
  • Instrument actuator 150 can be configured to move needle 156 relative to coupler 147.
  • Instrument actuator 150 can comprise a knob or a slider on housing 152 of child medical device 108 for advancement or retraction of needle 156 within sheath 154 so as to control how far distally from working channel 112 that needle 156 extends.
  • Instrument actuator 150 can thus be configured to extend needle 156 of child medical device 108 beyond a distal end of parent medical device 104, such as to engage with tissue.
  • instrument actuator 150 can advance and retract needle 156 to obtain a tissue sample.
  • Housing 152 can include indicia, which can indicate an amount of extension of child medical device 108 beyond a distal end of parent medical device 104, e.g., beyond working channel 112.
  • Functional section 128 of parent medical device 104 can include a transducer (or other imaging device), such as ultrasound sensor 149, and a side exit port for working channel 112 located proximal of the transducer for directing an instrument, e.g., needle 156 of child medical device 108, configured to perform medical procedures within the field of view of the transducer.
  • a transducer or other imaging device
  • side exit port for working channel 112 located proximal of the transducer for directing an instrument, e.g., needle 156 of child medical device 108, configured to perform medical procedures within the field of view of the transducer.
  • parent medical device 104 can include electrode 158 and needle 156, which can be configured as an electrode.
  • electrical energy can be delivered to the distal end of parent medical device 104 and child medical device 108.
  • the electrical energy can be configured to provide electrosurgical functionality and electroadhesive functionality, as described herein.
  • Electrode 158 and needle 156 can comprise conductors of electrical energy and can be fabricated of a conducting metal, such as stainless steel, copper, titanium and platinum, as well as other conducting materials such as graphite and carbon.
  • non-conducting materials can be embedded or mixed with conducting materials, such as plastics and polymers that are embedded, mixed or coated with conducting materials, coatings and/or particles.
  • Electrode 158 can be connected to one or more wires extending through insertion section 126 that connect to cable section 132 and coupler section 134 to receive electrical power (e.g., AC or DC current) from treatment generator 164 (FIG. 7B).
  • Needle 156 can be connected to one or more wires extending through sheath 154 that connect to cable section 159 to receive electrical power from treatment generator 164 (FIG. 7B) or another energy source (e.g., a battery). Additionally, the length of needle 156 between the distal tip and connection to housing 152 can be fabricated of conducting material such that a separate wire is not needed.
  • electrode 158 can comprise a strip or a rectangular shaped surface positioned on the exterior of insertion section 126 that faces in the same direction as sensor 220 (FIG. 8) to face toward tissue.
  • electrode 158 can comprise a ring that circumscribes insertion section 126.
  • electrode 158 can be proximal of functional section 128.
  • electrode 158 can be located on functional section 128, such as at the distal tip portion of functional section 128.
  • FIG. 7B is a schematic diagram of endoscopy system 100 of FIG. 1 including control system 102, parent medical device 104 and child medical device 108.
  • Parent medical device 104 and control system 102 can be configured to operate with an ultrasound arrangement.
  • Child medical device 108 can be extendable via a distal working channel port of parent medical device 104.
  • FIG. 2 schematically illustrates components of control system 102 coupled to parent medical device 104.
  • Control system 102 can include control unit 114, which can include or be coupled to image processing unit 162, treatment generator 164, and drive unit 166, as well as light source 120, input unit 118, and display unit 116.
  • Control unit 114 can include, or can be in communication with, an endoscope, a surgical instrument, and an endoscopy system, which can include a device configured to engage tissue and collect and store a portion of that tissue.
  • Control unit 114 can be configured to activate an imaging sensor, such as imaging device 144 or ultrasound sensor 149, to view target tissues distal of the endoscopy system.
  • control unit 114 can be configured to activate light source 120 to emit light waves from a distal end of parent medical device 104 onto child medical device 108, such as by using illumination device 146.
  • Coupler section 134 can be connected to control unit 114 to connect to parent medical device 104 to multiple features of control unit 114, such as image processing unit 162, treatment generator 164, or the like.
  • port 140 can be used to insert another instrument or device, such as a child scope or auxiliary scope, or a sampling needle, biopsy needle, ablation instrument, scalpel, or the like, into parent medical device 104.
  • Such instruments and devices can be independently connected to control unit 114 via cable section 132.
  • port 138 can be used to connect coupler section 134 to various inputs and outputs, such as video, air, light and electric.
  • Image processing unit 162, ultrasound image processing unit 168, and light source 120 can each interface with parent medical device 104 (e.g., at functional section 128) or child medical device 108 by wired or wireless electrical connections.
  • Control system 102 can accordingly illuminate an anatomical region, collect signals representing the anatomical region, process signals representing the anatomical region, and display images representing the anatomical region on display unit 116.
  • Ultrasound image processing unit 168 can be configured to receive ultrasonic signals from either of parent medical device 104 or child medical device 108, particularly ultrasound sensor 149, which can be converted into ultrasonic images and transmitted to display unit 116 or any other component of endoscopy system 100.
  • Control system 102 can include light source 120 to illuminate the anatomical region using light of a desired spectrum (e.g., broadband white light, narrow-band imaging using electromagnetic wavelengths, and the like). Control system 102 can connect (e.g., via an endoscope connector) to parent medical device 104 for signal transmission (e.g., light output from the light source, video signals from the imaging system in the distal end, diagnostic and sensor signals from a diagnostic device, and the like).
  • a desired spectrum e.g., broadband white light, narrow-band imaging using electromagnetic wavelengths, and the like.
  • Fluid source 122 (shown in FIG. 1) can be in communication with control unit 114 and can include one or more sources of air, saline, or other fluids, as well as associated fluid pathways (e.g., air channels, irrigation channels, suction channels, and the like) and connectors (barb fittings, fluid seals, valves, and the like).
  • Control system 102 can include drive unit 166, which can include a motorized drive for advancing a distal section of parent medical device 104.
  • Treatment generator 164 can be configured to output monopolar and/or bipolar energy to needle 156 and electrode 158, either via direct current or alternating current.
  • Monopolar energy can be applied, such as via direct current (DC), with an active electrode electrically connected to an electrosurgical generator.
  • a return electrode may also be electrically connected to the electrosurgical generator and placed in contact with a patient.
  • Typical return electrodes in a monopolar medical device can take the form of a patient pad that is located remotely from the electrosurgical medical device.
  • electrical current is passed from the electrosurgical generator to the active electrode, through a site or a region of the anatomy of the patient (e.g., a target tissue or an anatomic structure to be biopsi ed) to the patient pad, and back to the electrosurgical generator.
  • Needle 156 and electrode 158 can each be configured as the active electrode.
  • needle 156 can be configured as the active electrode to perform cutting, cauterizing and/or electro-adhesion using monopolar energy.
  • Bipolar energy can be applied, such as via direct current (DC), with an active electrode and a return electrode adjacent or in close proximity to the active electrode, both of which are electrically connected to an electrosurgical generator.
  • each electrode of a bipolar device can be located on or in the electrosurgical medical device.
  • an anatomic feature such as a lesion is placed between the active and return electrodes, and electrical current passes from the electrosurgical generator to the active electrode, through the anatomic feature to the adjacent return electrode, and then back to the electrosurgical generator.
  • Needle 156 and electrode 158 can each be configured as the active electrode or the return electrode.
  • needle 156 can be configured as the active electrode to perform cutting, cauterizing and/or electro-adhesion using bipolar energy.
  • RF energy can be used for cutting, sealing, cauterizing, coagulation and the like.
  • RF devices can apply alternating current (AC) energy at high frequency to allow for more targeted application of the electrical energy. For example, RF energy can more effectively reach certain types of tissues structures as compared to direct current (DC) or low frequency AC. For this and other reasons, RF devices can reduce the time that procedures take.
  • AC alternating current
  • needle 156 and electrode 158 can be activated to apply not only electrosurgical energy, but electro-adhesion energy
  • FIG. 7C is a schematic diagram of components of endoscopy system 100 suitable for use in applying high-frequency (RF) energy and electro-adhesion energy to an electrode.
  • Endoscopy system 100 can comprise control unit 114 and treatment generator 164, which can be connected to parent medical device 104, child medical device 108, or other devices.
  • Treatment generator 164 can comprise an alternating current generator, e.g., AC generator 170, and an electro-adhesion generator, e.g., EA generator 172.
  • Treatment generator 164 can further comprise first connector 174 and second connector 176.
  • First connector 174 can connect to needle 156, which can comprise an active electrode, through cable section 159 and second connector 176 can connect to electrode 158, which can comprise a neutral electrode, through cable section 132.
  • AC generator 170 can be used to apply electrical energy to tissue 186, such as at one or both of needle 156 and electrode 158.
  • the electrical energy can be used to modify, e.g., cut, coagulate or ablate, tissue 186.
  • AC generator 170 can be used to generate monopolar, bipolar and RF energy, as described above.
  • EA generator 172 can be used to apply electrical energy to tissue 186, such as at one or both of needle 156 and electrode 158.
  • the electrical energy can be used to induce the formation of a bond with surrounding gel and/or tissue.
  • EA generator 172 may provide alternating current (AC) and/or direct current (DC) to at least one of needle 156 and electrode 158.
  • the electro-adhesion energy can be used to intentionally adhere tissue to needle 156 for the collection of tissue samples so that the tissue sample can be separated from surrounding anatomy and collected from within the anatomy. This is to be distinguished from ablated or coagulated tissue that can undesirably stick to instrumentation due to the tissue becoming sticky in the modified state.
  • electro-adhesion can be used to cause sticking of desirable tissue samples to needle 156. That is, intact tissue that has not been ablated or cauterized where the natural characteristic of the tissue has been altered can be adhered to needle 156 for retrieval and analysis. Cutting or ablation of tissue can destroy characteristics of the tissue that can be useful in performing diagnosis of various conditions or diseases.
  • Voltages for inducing electro-adhesion can be low compared to electro-surgical levels.
  • electro-surgical cutting can use voltages of about two- hundred volts and higher, typically with alternating current in the range of one-hundred kilohertz to five megahertz. Coagulation can be achieved using cutting voltages as much lower duty cycles.
  • voltages in the range of approximately five volts to approximately ten volts DC can be used. Though higher voltages below two-hundred volts may be used, depending on desired tissue effect.
  • the electro-adhesion can be applied in the range of approximately five second to approximately thirty seconds, though other shorter or longer periods of time can be used.
  • electro- surgical cutting is typically applied in bursts less than five seconds to avoid various issues, such as interference with pacemakers and the like.
  • the electro-adhesion energy can be applied for approximately three minutes or more, depending on application.
  • high frequency (HF) AC generator 170 can be used to apply high frequency (HF), AC voltage, in kHz ranges typically used for electrosurgical coagulation, cutting and cauterizing, in addition to EA generator 172 that can be used to apply DC voltage over the HF energy or at a different time as the HF energy to produce an electro-adhesion effect.
  • EA generator 172 can be configured to provide a voltage level of zero to approximately twenty volts (V). Electro-adhesion can occur in in the range of approximately five volts to approximately ten volts. Current levels can be in the range of approximately zero milliamps (mA) to approximately two-hundred mA.
  • Electroadhesion can occur in the range of approximately two mA to approximately ninety mA.
  • the DC electro-adhesion voltage can be high enough to produce the desired effect of adhesion, but also low enough to fulfil safety requirements, such as the IEC 60601-1 requirements of patient leakage currents.
  • the DC electro-adhesion voltage can be modulated over the HF, AC voltage or can be generated separate from the HF, AC voltage.
  • the DC electro-adhesion voltage can be switchable, e.g., on/off and polarity switching.
  • stand-alone AC and DC generators can be used as opposed to being integrated into a single unit, such as treatment generator 164.
  • the electro-adhesion voltage (DC) can be applied intermittently alongside the HF Mode.
  • the electro-adhesion voltage (DC) can be controlled via a microcomputer or micro-controller, central processing unit or field programable gate array (pC / CPU / FPGA), such as those included in control unit 114.
  • FIG. 7D is a schematic diagram of child medical device 108 configured as an electro-adhesive biopsy device of the present disclosure.
  • child medical device 108 can be used for lung cancer biopsy procedures.
  • Child medical device 108 can comprise distal end 110, housing 152, sheath extension mechanism 148, instrument actuator 150, sheath 154, cable section 159 and port 192.
  • Distal end 110 can comprise needle 156, which can comprise needle 156 (FIG. 7C).
  • Housing 152 can include button 194, button 195 and button 196.
  • Port 192 can be connected to injector 198.
  • Child medical device 108 can be connected to control unit 114.
  • Injector 198 can be configured to hold a gel for dispensing to target tissue to facilitate one or both of ultrasound image transmission and electro-adhesion.
  • Injector 198 can comprise a dispensing container configured to hold a material and push or force the material into housing 152 for passage to needle 156.
  • injector 198 can comprise a syringe.
  • injector 198 can contain an acrylamide gel, a biopsy gel or an ultrasound gel.
  • Injector 198 can couple to port 192, such as through a threaded connection. Port 192 can connect to a lumen or passage within sheath 154 extending to needle 156.
  • Control unit 114 can be configured to manage the application of voltage and switching of polarity to needle 156 and electrode 158 (FIG. 7C), allowing the operator to control the process.
  • Control unit 114 can comprise a device for delivering electrical power to child medical device 108.
  • control unit 114 can comprise an electrical generator capable of generating bi-polar electrical power.
  • control unit 114 can generate DC power.
  • control unit 114 can generate AC power.
  • control unit 114 can generate AC and DC power.
  • control unit 114 can manage the application of voltage to needle 156 and the polarity of that voltage, e.g., switching between opposite polarities. Electrical power from control unit 114 can be provided to housing 152 via cable section 159. Wires from cable section 159 can connect to needle 156 within sheath 154.
  • control unit 114 can comprise the system of FIG. 7A.
  • Control unit 114 can be configured to apply electrical polarity to needle 156 and electrode 158 (FIG. 7C) to control the adhesion and detachment of tissue to needle 156 and/or gel from injector 198.
  • one electrode can comprise needle 156 and one electrode can be located on parent medical device 104 (FIG.
  • Housing 152 can include features for operation of child medical device 108.
  • housing 152 can comprise button 194 for applying electrical power to needle 156 for coagulation, e.g., to operate in Coagulation Mode.
  • housing 152 can comprise button 195 for applying electrical power to needle 156 for cutting, e.g., to operate in Cutting Mode.
  • housing 152 can comprise button 196 for applying electrical power to needle 156 for electro-adhesion.
  • Housing 152 can comprise sheath extension mechanism 148 for advancing and retracting sheath 154.
  • a wire or the like can extend between sheath extension mechanism 148 and sheath 154 to provide an actuation force.
  • Housing 152 can comprise instrument actuator 150 for advancing and retracting of needle 156.
  • a wire or the like can extend between instrument actuator 150 and needle 156 to provide an actuation force.
  • Housing 152 can include a stylet an inner solid needle through needle 156 to stiffen and blunt the tip of needle 156 during insertion, for example.
  • Control unit 114 can include user interface features for applying and switching polarity of electro-adhesion power, as well as for applying coagulating and cutting electrical energy.
  • control unit 114 can comprise button 198A and button 198B for applying electrical energy to needle 156 and electrode 158 (FIG. 7A).
  • control unit 114 can comprise output device 199 for displaying information related to electrical output be provided to needle 156 and electrode 158.
  • button 198A can cause an electric filed to be generated between needle 156 and electrode 158 (FIG.
  • button 198B can cause an electric field having a second polarity opposite the first polarity to be generated between needle 156 and electrode 158 to induce detachment or release of the electro-adhesion.
  • button 194 and button 195 are described as being on housing 152 and button 198 A and button 198B are described as being on control unit 114, housing 152 can include button 198 A and button 198B and control unit 114 can include button 194 and button 195.
  • housing 152 and control unit 114 can have redundant control of the electro-surgical and electro-adhesive features of the present disclosure.
  • any user interface can be used to control the electrical energy, such as knobs, switch and the like.
  • button 194, button 195, button 198 A and button 198B are described with reference to housing 152 and control unit 114, operation of the features of such buttons can be controlled by a robotic controller of an endoscopy system.
  • Needle 156 can comprise a cylindrical body having an internal lumen connected to housing 152. Needle 156 can be configured to pierce tissue and inject gel to a tissue site and collect tissue samples, using the gel and electro-adhesive energy. Sheath 154 can extend from housing 152 and can include an internal passage or lumen for receiving needle 156 and a fluid or gel. Sheath 154 can be flexible to bend with needle 156. In examples, needle 156 can comprise a rigid body, such as a body fabricated from metal such as stainless steel or another metal. However, needle 156 can be flexible so as to allow bending. In examples, needle 156 can comprise a stainless-steel hypo-tube including laser cuts to increase flexibility and can be enclosed in a polymeric sheath.
  • needle 156 can have axial rigidity, but radial flexibility.
  • Needle 156 can comprise a body configured for puncturing tissue.
  • the distal tip of needle 156 can be sharpened to facilitate piercing tissue.
  • the distal tip of needle 156 can be angled to facilitate piercing tissue.
  • a flexible tube can extend through sheath 154 between housing 152 and needle 156 to inject gel alongside needle rather than through needle.
  • Such a tube can extend to port 192 on housing 152.
  • Port 192 can comprise a fluid coupler for connecting to injector 198.
  • Needle 156 can be in electrical communication with control unit 114. Needle 156 can be conducting.
  • FIG. 8 through FIG. 12 describe an example method of using electro-adhesive biopsy device 200.
  • FIG. 8 through FIG. 12 illustrate a lung biopsy procedure to diagnose lung cancer using bronchoscopy, which can comprise endobronchial ultrasound scope 202.
  • bronchoscopy which can comprise endobronchial ultrasound scope 202.
  • other types of procedures can be performed with the devices, systems and techniques described herein, such as biopsy procedures in other anatomic locations.
  • FIG. 8 is a schematic diagram of an electro-adhesive biopsy procedure showing electro-adhesive biopsy device 200 extending from endobronchial ultrasound scope 202.
  • Electro-adhesive biopsy device 200 can comprise shaft 206 and needle 208.
  • Endobronchial ultrasound scope 202 can be inserted into anatomic duct 210 having duct wall 212. Lesion 214 can be located within matter of duct wall 212.
  • Endobronchial ultrasound scope 202 can comprise shaft 216, tip 218, sensor 220, lumen 222 and electrode 224. Needle 208 can be advanced from lumen 222 to form tissue passage 226.
  • endobronchial ultrasound scope 202 can comprise parent medical device 104 (FIG. 7 A) and electro-adhesive biopsy device 200 can comprise child medical device 108 (FIG. 7A).
  • Needle 208 and electrode 224 can be connected to control unit 114 (FIG. 7D) to receive a voltage from an electrical generator.
  • needle 208 and electrode 224 can be connected to AC generator 170 and EA generator 172.
  • Control unit 114 can apply voltages to needle 208 to perform electro-surgical operations, such as cutting and coagulation.
  • control unit 114 can apply voltages of opposite polarities to cause tissue to stick to needle 208 and release from needle 208.
  • needle 208 can comprise a positive anode and electrode 224 can comprise a negative anode
  • needle 208 can comprise a negative anode and electrode 224 can comprise a positive anode.
  • methods of the present disclosure can comprise: A) Preparation: Position the device near the body of the patient and align the biopsy needle with the lung tissue targeted for biopsy, using Cutting Mode for applying energy to the needle; B) Adhesion: Contact the lung tissue with the acrylamide gel and apply voltage through the electrode to adhere the gel to the tissue; C) Biopsy: While the gel is adhered to the tissue, use the biopsy needle to collect a tissue sample; and D) Detachment: Switch the polarity to detach the gel from the tissue.
  • endobronchial ultrasound scope 202 can utilize imaging from sensor 220 to position tip 218 within anatomic duct 210, which can comprise a nodule of a lung.
  • a user can manipulate endobronchial ultrasound scope 202 to position sensor 220 into engagement with duct wall 212 to facilitate obtaining imaging, such as ultrasound images.
  • gel can be applied to duct wall 212 to facilitate transmission of sound waves from sensor 220 to lesion 214.
  • injector 198 FIG. 7D
  • the gel can comprise a water-based gel formulated to have an acoustic impedance similar to skin and tissue, minimizing reflections and allowing clearer imaging.
  • images of lesion 214 can be displayed on display unit 116 (FIG. 7A) of control system 102 to facilitate positioning of endobronchial ultrasound scope 202.
  • Needle 208 can be positioned by endobronchial ultrasound scope 202 and advanced using sheath extension mechanism 148 and instrument actuator 150 (FIG. 7D) to position needle 208 along a trajectory to intersect with lesion 214.
  • control unit 114 can be operated to electrically activate needle 208.
  • control unit 114 can apply various waveforms of electrical energy to needle 208 to facilitate cutting of tissue.
  • the distal tip portion of needle 208 can function as a bipolar active electrode.
  • Control unit 114 can be activated to output in the Cutting Mode, e.g., at high voltage and high frequency for a constant amount of output (e.g., a steady duty cycle).
  • Needle 208 can be advanced while being electrically activated in a cutting mode to facilitate smooth entry into and penetration through tissue of duct wall 212. Thus, needle 208 can easily penetrate through tissue of duct wall 212 to form tissue passage 226.
  • a return electrode can be installed on endobronchial ultrasound scope 202, such as at electrode 224, particularly if endobronchial ultrasound scope 202 is configured to be single- use. For example, inclusion of an electrode, such as a pad that provides a relatively large surface, may result in tissue remnants, e.g., burnt tissue particles, being caked on the electrode, thereby making cleaning and reprocessing more difficult. Thus, inclusion of an electrode on the device is well-suited for a disposable device that will not be reprocessed.
  • control unit 114 can be activated in Coagulation Mode, e.g., at high voltage and high frequency for an attenuated amount of output (e.g., an intermittent duty cycle), to stop or limit the bleeding.
  • Coagulation Mode e.g., at high voltage and high frequency for an attenuated amount of output (e.g., an intermittent duty cycle), to stop or limit the bleeding.
  • FIG. 9 is a schematic diagram of the electro-adhesive biopsy procedure of FIG. 8 showing biopsy gel being injected into target tissue.
  • a gel such as acrylamide gel
  • injector 198 FIG. 7D
  • injector 198 FIG. 7D
  • acrylamide gel can be injected into the area of interest for biopsy to form gel pod 228.
  • the extent of this injection can be observed in real-time using the endoscopic ultrasound that can be obtained from sensor 220, allowing for precise confirmation that the acrylamide gel has been injected into the correct area.
  • the gel can interact with the atoms of lesion 214 to facilitate bonding of the atoms of lesion 214 to needle 208 when activated with electro-adhesion energy.
  • the volume and outer shape of gel pod 228 can be used to set the boundary for where tissue will be separated from lesion 214 and anatomic duct 210.
  • FIG. 10 is a schematic diagram of the electro-adhesive biopsy procedure of FIG. 9 showing a voltage being applied to the target tissue of lesion 214 from needle 208.
  • An adhesion can be formed by contacting tissue of lesion 214 with the gel of needle 208 and applying a voltage to needle 208.
  • the voltage can be applied to needle 208 by control unit 114 using treatment generator 164 to produce electro-adhesion.
  • Voltage can be applied with needle 208 in contact with gel pod 228.
  • the voltage applied by control unit 114 can comprise low voltage, direct current for a short period of time. Applying voltage allows tissue to adhere to the electrode of needle 208 with minimal damage to the tissue.
  • a chemical bond can be formed between the atoms of the combination of lesion 214 and gel pod 228 and the atoms of needle 208 without causing damage to the tissue of lesion 214.
  • the electro-adherence between the tissue and needle 208 can be stronger within the area injected with biopsy gel than the force required to detach portions of lesion 214 from anatomic duct 210.
  • the adhesion force e.g., the bonding caused by electrical forces between tissue and electrode
  • tissue detachment e.g., the force required to separate tissue bonded to needle 208 from surrounding tissue, such as by tearing of tissue.
  • electro-adhesion and tissue extraction can be performed without the use of gel. Gel can, however, be used to better control the boundary where tissue will be torn.
  • FIG. 11 is a schematic diagram of the electro-adhesive biopsy procedure of FIG. 10 showing the target tissue of lesion 214 being pulled through tissue passage 226 formed by needle 208.
  • the biopsy gel of gel pod 228 can be adhered to the tissue of lesion 214 and needle 208.
  • needle 208 can be used to collect a tissue sample 230.
  • FIG. 11 illustrates the act of physically pulling needle 208 proximally toward endobronchial ultrasound scope 202.
  • the electro-adhesion energy applied in FIG. 10 can be stopped at this point.
  • Tissue sample 230 is torn from lesion 214 to leave void 232.
  • the adhesive force between the tissue and the electrode is significantly greater than the force required for tissue tearing. Therefore, by physically pulling needle 208, the tissue tears at the boundary between the part adhered to the tissue with acrylamide gel and the normal tissue. Furthermore, due to the low voltage applied to the tissue, the amount of structural damage inflicted upon the tissue is minimal, allowing for the retrieval of tissue suitable for biopsy.
  • FIG. 12 is a schematic diagram of needle 208 of FIG. 11 with the target tissue inserted into container 240 of saline solution 242.
  • the tissue that was torn from anatomic duct 210 and removed from the body of the patient can be placed in container 240 containing saline solution 242 to facilitate separation of tissue sample 230 from needle 208.
  • Detachment of tissue sample 230 can be achieved by switching the polarity of voltage applied to needle 208 via control unit 114 (FIG. 7D) to detach the gel and tissue combination as compared to the polarity that was applied to needle 208 in FIG. 10 to cause the electro-adhesion to be formed.
  • the tissue By reversing the polarity and applying output, e.g., setting control unit 114 to a tissue detachment mode, from the electrode, the tissue can be cleanly detached from the electrode.
  • Saline solution 242 can be used to preserve tissue sample 230 until being analyzed.
  • FIG. 13A is a perspective view of cutting electrode 300 that can be used as an electro-adhesive cutting biopsy device.
  • Cutting electrode 300 can comprise head 302 and shaft 304.
  • Head 302 can comprise distal portion 306 and proximal portion 308.
  • Shaft 304 can comprise distal portion 310 and proximal portion 312.
  • FIG. 13B is a schematic cross- sectional view of cutting electrode 300 of FIG. 13A showing wire 330 and wire 332 for distal portion 306 and distal portion 310, respectively, and coating 334.
  • FIG. 13 A and FIG. 13B are discussed concurrently.
  • cutting electrode 300 can include passageway 326, e.g., a tube, that can extend between port 327 in head 302 and injector 198.
  • Distal portion 306 can be configured, e.g., shaped, for piercing tissue.
  • distal portion 306 can comprise a pointed tip and a wide base. The pointed tip can be configured to pierce tissue, and the wide base can be configured to spread tissue, thereby facilitating tunneling through tissue.
  • distal portion 306 can comprise a cone- shaped body or a pyramid shaped body.
  • distal portion 306 can comprise a polyhedral convex cone having a plurality of facets, such as eight triangular surfaces.
  • distal portion 306 can comprise a solid piece of material so as to not be cannulated. That is, tissue is not configured to enter into distal portion 306.
  • Distal portion 306 of head 302 can be coated or can be free of coatings.
  • distal portion 306 can include coating 334.
  • coating 334 can comprise a non-stick coating.
  • coating 334 can comprise a polymeric-based coating, such as a fluoropolymer type coating.
  • coating 334 can comprise a Polytetrafluoroethylene (PTFE) coating.
  • coating 334 can comprise a polysiloxane or a fluorosilane coating.
  • materials such as silicone and silicone resins can be used.
  • the silicone and silicone resins can be applied using a plasma deposition process to precisely control the thickness and withstand the heat generated during, for example, tissue cutting.
  • Silicone resins suitable for coating 334 can include, but are not limited to, polydimethyl siloxanes, polyester-modified methylphenyl polysiloxanes, such as polymethylsilane and polymethylsiloxane, and hydroxyl functional silicone resins.
  • coating 334 can be made from a composition including a siloxane, which can include hexamethyldisiloxane, hexadimethylsiloxane, tetramethylsilane, hexamethyldisilazane, or any combination thereof.
  • coating 334 can be a polydimethylsiloxane (“PMDSO”) coating.
  • coating 334 can be a hexamethyldisiloxane (“HMDSO”) coating.
  • coating 334 can be a tetramethyldisiloxane (TMDSO or TMDS).
  • coating 334 can include a thin layer of hexamethyldisiloxane (HMDSO), such as having a thickness of about 1-5 nanometers.
  • HMDSO hexamethyldisiloxane
  • coating 334 can include a thin layer of hexamethyldisiloxane (HMDSO), such as having a thickness of about 1-5 nanometers.
  • HMDSO hexamethyldisiloxane
  • HMDSO hexamethyldisiloxane
  • coating 334 can include an etched coating or etched layer, such as including one or more hydrophobic pillars superimposed onto an electrode plate of an electrosurgical instrument.
  • a nanostructure of the hydrophobic pillars can act as a superhydrophobic coating having a low surface energy to reduce tissue adhesion or stiction.
  • Such an etched coating can be formed in any suitable pattern for coating 334 to reduce or prevent tissue adhesion, and can be applied, for example, by printing, chemical etching, laser etching, chemical bombardment, or other techniques.
  • Proximal portion 308 of head 302 can be joined to distal portion 306.
  • Proximal portion 308 can comprise a tapered portion relative to moving in the distal-to-proximal direction.
  • proximal portion 308 can be part of head 302 or shaft 304.
  • proximal portion 308 can be part of the electroadhesion surface of distal portion 310 or part of the electro-cut surface of head 302.
  • proximal portion 308 can comprise a separate piece that is an electrical insulator to separate distal portion 306 from distal portion 310, thereby preventing cutting energy of distal portion 306 from energizing distal portion 310.
  • an additional insulation layer can be included in cutting electrode 300 to separate electro-cutting surfaces and electroadhesion surface.
  • Proximal portion 308 can be coated or can be free of coatings.
  • proximal portion 308 can include an adhesive coating or texturing, as explained below.
  • Distal portion 310 can comprise an extension of shaft 304 that is proximal of head 302.
  • Distal portion 310 can be cylindrical in shape, as illustrated. However, distal portion 310 can have other cross-sectional shapes, such as square, rectangular, hexagonal and octagonal.
  • Distal portion 310 can be configured to provide a large surface area for obtaining a tissue sample.
  • distal portion 310 can be fabricated of metal material that is conductive, such as stainless steel, copper, titanium and platinum.
  • Distal portion 310 can be connected to EA generator 172 (FIG. 7D) via wire 332 (FIG. 13B).
  • Distal portion 310 can be coated or can be free of coatings.
  • distal portion 310 can include an adhesive coating or texturing.
  • adhesive coatings of the present disclosure can allow tissue to stick to portions of cutting electrode 300.
  • the adhesive coating can facilitate sticking of tissue to cutting electrode 300 when activated, e.g., such as when an electrical voltage is applied thereto.
  • distal portion 310 can be textured, such as to increase or decrease the smoothness of the surfaces of distal portion 310. The smoothness of distal portion 310 can be selected to enhance or alter the electro-adhesion force.
  • an adhesive coating can comprise an electroadhesion-promoting coating, such as a coating made of a material, mixture, colloid or suspension of a material that facilitates electro-adhesion, such as conductive metals, graphite and carbon.
  • Cutting electrode 300 can be connected to control unit 314 via cable 315.
  • Control unit 314 can comprise an implementation of control unit 114 or can comprise the electro- surgical system of FIG. 7D.
  • Cable 315 can include wire 330 and wire 332.
  • Application of coagulation energy to distal portion 306 can be controlled by button 194, application of cutting energy to distal portion 306 can be controlled by button 195, and application of electro-adhesion energy to distal portion 310 can be controlled by button 198 A and button 198B.
  • FIG. 14 is a perspective view of cutting electrode 300 of FIG. 13A showing tissue sample 329 adhered to the cutting electrode.
  • Distal portion 306 can be configured to produce a hole or passage through tissue to reach the cite of target tissue.
  • the base of distal portion 306 can have a diameter larger than the diameter of distal portion 310.
  • tissue collected by distal portion 310 can be recessed relative to distal portion 306 to facilitate retrieval back through a passage formed by distal portion 306. That is, as cutting electrode 300 is pulled for retrieval back into an endoscope (downward relative to the orientation of FIG. 14), the wide base of distal portion 306 can act as a backstop to prevent tissue sample 329 from being pushed off of cutting electrode 300.
  • FIG. 15 through FIG. 19 describe an example method of using cutting electrode 300.
  • FIG. 15 through FIG. 19 illustrate a lung biopsy procedure to diagnose lung cancer using bronchoscopy, which can comprise endobronchial ultrasound scope 316.
  • bronchoscopy which can comprise endobronchial ultrasound scope 316.
  • other types of procedures can be performed with the devices, systems and techniques described herein, such as biopsy procedures in other anatomic locations.
  • FIG. 15 is a schematic diagram of an electro-adhesive biopsy procedure showing cutting electrode 300 extending from endobronchial ultrasound scope 316 in the line of site of target tissue, which can comprise lesion 337.
  • Cutting electrode 300 can comprise head 302 and shaft 304.
  • Endobronchial ultrasound scope 316 can be inserted into anatomic duct 328 having duct wall 335.
  • Lesion 337 can be located within matter of duct wall 335.
  • Cutting electrode 300 can be advanced to form tissue passage 336.
  • Endobronchial ultrasound scope 316 can comprise shaft 317, tip 318, sensor 320, lumen 322 and electrode 324.
  • Endobronchial ultrasound scope 316 can be configured similarly as endobronchial ultrasound scope 202 of FIG. 8 through FIG. 11.
  • Endobronchial ultrasound scope 316 can utilize imaging from sensor 320 to position tip 318 within anatomic duct 328, which can comprise a nodule of a lung.
  • a user can manipulate endobronchial ultrasound scope 316 to position sensor 320 into engagement with duct wall 335 to facilitate obtaining imaging, such as ultrasound images.
  • gel can be applied to duct wall 335 to facilitate transmission of sound waves from sensor 320 to lesion 337.
  • injector 198 FIG. 7D
  • injector 198 can be used to push gel through endobronchial ultrasound scope 316, such as by the inclusion of passageway 326 from port 192, within shaft 304 and to distal portion 310.
  • the gel can comprise a waterbased gel formulated to have an acoustic impedance similar to skin and tissue, minimizing reflections and allowing clearer imaging.
  • images of lesion 337 can be displayed on display unit 116 (FIG. 7 A) of control system 102 to facilitate positioning of endobronchial ultrasound scope 316.
  • Cutting electrode 300 can be positioned by endobronchial ultrasound scope 316 and advanced using sheath extension mechanism 148 and instrument actuator 150 (FIG. 7D) to position cutting electrode 300 along a trajectory to intersect with lesion 337.
  • Endobronchial ultrasound scope 316 can approach lesion 337 but cannot reach it by simple insertion due to, for example, the narrowing size of the lung nodules.
  • the bronchi become smaller than the head of endobronchial ultrasound scope 316, making it difficult or impossible to advance further.
  • CT or ultrasound techniques such as EBUS, it is possible to see in real time that there is more tissue deeper inside.
  • sensor 320 can be used to obtain imaging for displaying on display unit 116 (FIG. 7A), which can be used to insert cutting electrode 300 proximate to lesion 337.
  • FIG. 16 is a schematic diagram of the electro-adhesive biopsy procedure of FIG.
  • a user can manipulate cutting electrode 300, such as by using sheath extension mechanism 148 and instrument actuator 150 (FIG. 7D) to advance head 302 to lesion 337.
  • button 195 can be used to apply electro- surgical cutting energy to head 302 of cutting electrode 300.
  • distal portion 306 of head 302 can receive RF energy from AC generator 170 (FIG. 7C) in Cutting Mode to slowly and carefully advance cutting electrode 300 to approach the target site of lesion 337.
  • Head 302 can be advanced distally past lesion 337 to position shaft 304 proximate or adjacent to lesion 337.
  • FIG. 17 is a schematic diagram of the electro-adhesive biopsy procedure of FIG.
  • Electrode 16 showing voltage being applied to shaft 304 of cutting electrode 300.
  • An electric field can be applied to distal portion 310 of shaft 304 to cause lesion 337 to adhere to distal portion 310.
  • AC generator 170 (FIG. 7C) can be operated in Coagulation Mode using button 194.
  • EA generator 172 (FIG. 7C) can be operated to apply low voltage DC current to distal portion 310.
  • electro-adhesion energy can be applied to distal portion 310 for approximately three to approximately five seconds with continuous output. As such, electro-adhesion can cuase tissue of lesion 337 to bond to distal portion 310 using the phenomena described herein. After stopping the output and waiting for about ten seconds for distal portion 310 to cool, cutting electrode 300 can be retracted toward endobronchial ultrasound scope 316.
  • FIG. 18 is a schematic diagram of the electro-adhesive biopsy procedure of FIG.
  • FIG. 17 showing cutting electrode 300 being retracted with tissue sample 340 adhered thereto.
  • Cutting electrode 300 can be retracted toward endobronchial ultrasound scope 316 to remove tissue sample 340 from anatomic duct 328.
  • FIG. 18 illustrates the act of physically pulling cutting electrode 300 proximally toward endobronchial ultrasound scope 316.
  • the electro- adhesion energy applied in FIG. 17 can be stopped at this point.
  • Tissue sample 340 is tom from lesion 337 to leave a void therein.
  • gel can be injected to the site of distal portion 310 to facilitate the electro-adhesion effect, as described herein. Due to the low voltage applied to the tissue, the amount of structural damage inflicted upon the tissue is minimal, allowing for the retrieval of tissue suitable for biopsy.
  • FIG. 19 is a schematic diagram of the electro-adhesive biopsy procedure of FIG. 18 showing cutting electrode 300 retracted toward and into endobronchial ultrasound scope 316 with a target tissue sample.
  • Cutting electrode 300 and tissue sample 340 can retracted into cavity 342 of lumen 322. Cavity 342 can comprise a widened portion of lumen 322 to accommodate tissue sample 340. Additionally, tissue sample 340 can be trapped between distal portion 306 of head 302 and material of tip 318. Thereafter, cutting electrode 300 and endobronchial ultrasound scope 316 can be withdrawn from the anatomy to retrieve tissue sample 340 for analysis. Once withdrawn, an electric field can be applied to distal portion 310 to reverse the electro-adhesive effect induced therein, as described herein. Furthermore, tissue sample 340 can be released to a saline solution to preserve the tissue sample.
  • FIG. 20 is an illustration of electro-adhesion tip 400 suitable for use with the electro-adhesion biopsy devices of the present disclosure.
  • Electro-adhesion tip 400 can be disposed in sheath 402.
  • Electro-adhesion tip 400 can comprise tip 404, tapered portion 406 and body 408.
  • Electro-adhesion tip 400 can be coupled to shaft 410.
  • Electro-adhesion tip 400 can be connected to wire 412 for coupling to treatment generator 164 (FIG. 7B).
  • Tip 404 can be elongated and narrow to facilitate puncturing into tissue. Tip 404 can be coated with an anti-adhesion layer, e.g., a non-stick coating, as described herein.
  • an anti-adhesion layer e.g., a non-stick coating
  • Electro-adhesion tip 400 can be configured to be moved in and out of sheath 402, such as by manipulation of sheath extension mechanism 148 and instrument actuator 150.
  • cutting electrode 300 can include cooling circuit 420, which can be connected to inlet line 422 and outlet line 424. Inlet line 422 and outlet line 424 can be connected to cooling source 426. Cooling circuit 420 can comprise a pathway fabricated into the material of cutting electrode 300 to receive and transmit fluid from inlet line 422 and outlet line 424. In examples, cooling circuit 420 can comprise tubing wrapped around cutting electrode 300. In examples, cooling source 426 can comprise a pressurized source of cold water or saline. Cooling circuit 420 can be used to regulate the temperature of the surface of cutting electrode 300 that comes into contact with the tissue.
  • a similar cooling circuit can be included in cutting electrode 300 of FIG. 13A.
  • FIG. 21 is an illustration of electro-adhesion tip 450 used in conjunction with collection sheath 452 to prevent collected tissue sample 454 from being dislodged during retrieval.
  • Electro-adhesion tip 450 can comprise a needle having pointed tip 456 and cannulated shaft 458.
  • Sheath 460 can be disposed about cannulated shaft 458.
  • Collection sheath 452 can be disposed about sheath 460.
  • Actuator 462 can be connected to collection sheath 452. Actuator 462 can be advanced and retracted to selectively cover electro-adhesion tip 450 and tissue sample 454.
  • Collection sheath 452 can prevent tissue sample 454 from being rolled up.
  • collection sheath 452 can act like a finger trap, which can comprise a woven tube that can radially expand, e.g., increase in diameter, when subject to axially compressive forces and radially contract when subject to axially tensile forces.
  • collection sheath 452 can be pushed over a tissue sample, which can tend to allow collection sheath 452 to radially expand to fit over the tissue sample.
  • collection sheath 452 is pulled out of the anatomy, which can tend to radially collapse collection sheath 452 over the tissue sample. Thereafter, collection sheath 452 can be pulled, rolled or cut to allow for retrieval of the tissue sample.
  • Collection sheath 452 can have a mechanical configuration designed to prevent tissue sample 454 from peeling off electro-adhesion tip 450 or causing seeding along the pathway.
  • FIG. 22 is a block diagram illustrating operations in method 500 of obtaining a tissue sample using an electro-adhesion biopsy needle.
  • method 500 can encompass the use of any medical device having biopsy capabilities, electro-surgical energy and electro-adhesion energy consistent with the methods and systems described herein.
  • Method 500 can additionally include fewer or greater operations other than operation 502 to operation 514. Additionally, in other examples, operation 502 through operation 514 can be performed in other sequences.
  • target tissue can be approached with an electrode needle.
  • electro-adhesive biopsy device 200 (FIG. 8) can be positioned to approach lesion 214 comprising the target tissue.
  • lesion 214 can comprise a nodule within a lung of a patient.
  • electro-adhesive biopsy device 200 can be pushed though tissue of duct wall 212 using sharpened features of electroadhesive biopsy device to reach lesion 214.
  • electro-adhesive biopsy device 200 can be electro-surgically activated to cut through tissue of duct wall 212 to reach lesion 214.
  • high frequency, alternating current from AC generator 170 (FIG.
  • electro-adhesive biopsy device 200 can be applied to electro-adhesive biopsy device 200.
  • the tip of electro-adhesive biopsy device 200 can be penetrated into lesion 214 so that material of electro-adhesive biopsy device 200 can be adjacent and in contact with material of lesion 214.
  • biopsy gel can be introduced proximate the target tissue.
  • use of biopsy gel and operation 504 can be omitted.
  • injector 198 can be connected to port 192.
  • a user can operate injector 198 to move gel through child medical device 108 to needle 156. The gel can exit a cannulation of needle 156 and penetrate into tissue of lesion 214.
  • a voltage of a first polarity can be applied at the target tissue.
  • low voltage, direct current energy from EA generator 172 (FIG. 7D) can be applied to electro-adhesive biopsy device 200, specifically to needle 208.
  • An electric field can be generated between needle 208 and tissue of lesion 214.
  • an electro-adhesion bond can be formed between the target tissue and the electrode needle. Atoms of the gel and target tissue can be shared with atoms of the biopsy needle. The electric field can cause atoms of lesion 214 to form a bond with the atoms of needle 208, thereby adhering tissue of lesion 214 to needle 208.
  • the gel introduced at operation 504 can facilitate the transfer of atoms between lesion 214 and needle 208. Thus, tissue sample 230 can become bonded to needle 218.
  • the needle with the target tissue attached can be withdrawn.
  • Needle 208 can be withdrawn into or toward endobronchial ultrasound scope 202.
  • Tissue sample 230 can be tom from lesion 214 to leave void 232 using the adhesive force between the tissue and the electrode. Therefore, a user can physically pull needle 208 to dislodge tissue sample 230 from the anatomy.
  • a cooling system such as cooling circuit 420 and cooling source 426 (FIG. 20) can be used to cool needle 208, before retracting needle 208 into endobronchial ultrasound scope 202.
  • a sheath such as collection sheath 452 (FIG. 21), can be advanced to retain tissue sample 230 against needle 208.
  • voltage of a second polarity can be applied at the target tissue.
  • EA generator 172 (FIG. 7D) can be applied to electro-adhesive biopsy device 200, specifically to needle 208.
  • the electro-adhesion bond between the target tissue and the electrode needle can be broken.
  • An electric field can be generated between needle 208 and tissue of lesion 214 that is of the opposite polarity that is generated at operation 506.
  • the electric field can cause atoms of lesion 214 to release from the atoms of needle 208, thereby allowing tissue of lesion 214 to be separated from needle 208 without tearing.
  • FIG. 23 is a block diagram illustrating operations in method 600 of obtaining a tissue sample using an electro-adhesion biopsy needle.
  • method 600 can encompass the use of any medical device having biopsy capabilities, electro-surgical energy and electro-adhesion energy consistent with the methods and systems described herein.
  • Method 600 can additionally include fewer or greater operations other than operation 602 to operation 616. Additionally, in other examples, operation 602 through operation 616 can be performed in other sequences.
  • target tissue can be approached by a scope, such as a bronchoscope.
  • a scope such as a bronchoscope.
  • cutting electrode 300 FIG. 13 A
  • lesion 337 can comprise a nodule within a lung of a patient.
  • an electrode tip can be energized.
  • cutting electrode 300 can be electro-surgically activated to cut through tissue of duct wall 335 to reach lesion 337.
  • high frequency, alternating current from AC generator 170 FIG. 7D can be applied to cutting electrode 300.
  • the electrode tip can be advanced to target tissue.
  • the tip of cutting electrode 300 can be penetrated past lesion 337 so that material of distal portion 310 can be adjacent and in contact with material of lesion 337.
  • a voltage of a first polarity can be applied at the target tissue.
  • low voltage, direct current energy from EA generator 172 (FIG. 7D) can be applied to cutting electrode 300, specifically to distal portion 310.
  • An electric field can be generated between distal portion 310 and tissue of lesion 337.
  • an electro-adhesion bond can be formed between the target tissue and the electrode tip.
  • Atoms of lesion 337 can be shared with atoms of cutting electrode 300.
  • the electric field can cause atoms of lesion 337 to form a bond with the atoms of cutting electrode 300, thereby adhering tissue of lesion 337 to cutting electrode 300.
  • tissue sample 340 can become bonded to cutting electrode 300.
  • the electrode tip with the target tissue attached can be withdrawn.
  • Cutting electrode 300 can be withdrawn into or toward endobronchial ultrasound scope 316.
  • Tissue sample 340 can be tom from lesion 337 to leave a void using the adhesive force between the tissue and the electrode. Therefore, a user can physically pull cutting electrode 300 to dislodge tissue sample 340 from the anatomy.
  • a cooling system such as cooling circuit 420 and cooling source 426 (FIG. 20) can be used to cool cutting electrode 300, before retracting cutting electrode 300 into endobronchial ultrasound scope 316.
  • a sheath such as collection sheath 452 (FIG. 21), can be advanced to retain tissue sample 340 against cutting electrode 300.
  • a voltage of a second polarity can be applied at the target tissue.
  • a voltage of a second polarity opposite the first polarity
  • direct current energy from EA generator 172 can be applied to cutting electrode 300, specifically to distal portion 310.
  • the electro-adhesion bond between the target tissue and the electrode tip can be broken.
  • An electric field can be generated between cutting electrode 300 and tissue of lesion 337 that is of the opposite polarity that is generated at operation 608.
  • the electric field can cause atoms of lesion 337 to release from the atoms of distal portion 310, thereby allowing tissue of lesion 337 to be separated from cutting electrode 300 without tearing.
  • the systems devices and methods of the present disclosure provide advantages for obtaining biopsy samples as compared to other systems, such as cryo-biopsy systems.
  • the EABDs of the present disclosure use a gentle, e.g., low voltage, electro-adhesive process that minimizes tissue trauma to both the tissue sample and the surrounding tissue. Cryo-biopsy results in freezing of tissue samples, which can help in preserving the tissue structure, but can also cause significant damage to the surrounding tissue due to the freezing process, resulting in bleeding. However, with the present disclosure, the retrieved tissue sample can have substantially the same characteristics as when attached to the anatomy without undergoing freezing or other structural damage.
  • the EABADs of the present disclosure can have improved control over sample size. Using electro-adhesion, EABDs can precisely access and collect specific tissue parts, targeting only the necessary areas and minimizing the impact on surrounding healthy tissues, such as by controlling the amount of gel injected or the size of the electrode. Thus, the risk of obtaining insufficient or excessively large samples can be reduced, which can be a concern with cryo-biopsy.
  • Non-invasiveness The EABDs of the present disclosure can cause less tissue damage to tissue surrounding the tissue sample, thereby allowing for faster recovery and less post-procedure pain compared to traditional methods using needles, forceps, or brushes. This is especially advantageous for repeated biopsies or the collection of delicate tissues.
  • the electrodes present on the EABDs can immediately perform hemostasis via the application of an electrical waveform to the tissue from a control unit.
  • the EABDs of the present disclosure can lower the risk of complications. Cryo-biopsy can have a higher risk of complications such as bleeding and pneumothorax (collapsed lung) due to the nature of the procedure.
  • the methods of using EABDs described herein reduce such risks by adhering and detaching tissue with electroadhesion in a manner that reduces bleeding.
  • the EABDs of the present disclosure can allow for immediate sample analysis. Unlike cryo-biopsy, where the frozen samples need to be thawed before analysis, samples obtained with the EABD can be analyzed immediately, speeding up the diagnostic process.
  • the EABDs of the present disclosure also have rapid electroadhesion and detachment processes that speed up the biopsy procedure and provide immediacy, reducing surgery time and facilitating quicker patient recovery.
  • the devices of the present disclosure utilize electrodes, making it flexible all the way to the tip. This can increase accessibility when combined with the scope, allowing the device to reach places previously inaccessible. Furthermore, since there is no need for repeated forceful stabbing actions like with a needle, the EABDs will not break or bend.
  • Example l is a biopsy probe comprising: a sheath comprising an internal lumen; a biopsy instrument extending within the sheath, the biopsy instrument comprising a head configured to pierce tissue; and a controller configured to control application of electrical energy to the biopsy instrument.
  • Example 2 the subject matter of Example 1 optionally includes an electrical generator connected to the controller, the electrical generator configured to: apply a voltage to the biopsy instrument at a first polarity to cause tissue to attract or adhere to the biopsy instrument via an electrical phenomena; and apply a voltage having a second polarity opposite the first polarity to release the electrical phenomena.
  • an electrical generator connected to the controller, the electrical generator configured to: apply a voltage to the biopsy instrument at a first polarity to cause tissue to attract or adhere to the biopsy instrument via an electrical phenomena; and apply a voltage having a second polarity opposite the first polarity to release the electrical phenomena.
  • Example 3 the subject matter of Example 2 optionally includes a handle that receives the biopsy instrument and the sheath, wherein the handle comprises a user interface to operate the controller.
  • Example 4 the subject matter of any one or more of Examples 1-3 optionally include wherein the head comprises a needle tip and the biopsy instrument further comprises a cannulated shaft extending from the head proximally through the sheath.
  • Example 5 the subject matter of any one or more of Examples 1-4 optionally include wherein the head comprises: a bulbous portion located at a distal end portion of the biopsy instrument, the bulbous portion configured to be pushed through tissue; and a cylindrical portion proximal of the bulbous portion, the cylindrical portion having a smaller cross-sectional area than the bulbous portion.
  • Example 6 the subject matter of Example 5 optionally includes wherein the bulbous portion comprises a non-stick coating.
  • Example 7 the subject matter of any one or more of Examples 1-6 optionally include wherein the head comprises: an elongate tip; a conical portion extending proximally from the elongate tip; and a cylindrical portion extending proximally from the conical portion.
  • Example 8 the subject matter of any one or more of Examples 1-7 optionally include a lead wire connected to the head and extending proximally within the internal lumen.
  • Example 9 the subject matter of any one or more of Examples 1-8 optionally include a collection sheath positioned over the sheath, the collection sheath configured to move distally to cover the head distally of the sheath.
  • Example 10 the subject matter of any one or more of Examples 1-9 optionally include a cooling circuit in communication with the biopsy instrument.
  • Example 11 is a system for obtaining a biopsy sample, the system comprising: a biopsy probe comprising: an elongate insertion shaft; and a biopsy instrument extending from a distal end portion of the elongate insertion shaft; and an electrical generator configured to: at a first time, apply a first voltage to the biopsy instrument at a first polarity to cause adhesion of a tissue sample to the biopsy instrument; and at a second time subsequent to the first time, apply a second voltage to the biopsy instrument at a second polarity to cause detachment of the tissue sample to the biopsy instrument.
  • Example 12 the subject matter of Example 11 optionally includes wherein: the first voltage causes a chemical bond to form between the tissue sample to the biopsy instrument; and the second voltage causes the chemical bond between the tissue sample and the biopsy instrument to be released.
  • Example 13 the subject matter of any one or more of Examples 11-12 optionally include an endoscope comprising: a shaft; a lumen extending through the shaft to receive the elongate insertion shaft of the biopsy probe; and a sensor for obtaining imaging of anatomy into which the endoscope is inserted.
  • an endoscope comprising: a shaft; a lumen extending through the shaft to receive the elongate insertion shaft of the biopsy probe; and a sensor for obtaining imaging of anatomy into which the endoscope is inserted.
  • Example 14 the subject matter of Example 13 optionally includes wherein the endoscope includes an electrode in communication with the electrical generator.
  • Example 15 the subject matter of Example 14 optionally includes wherein the biopsy instrument comprises a needle comprising: a pointed tip having a cannulation; and a shaft extending form the pointed tip and having a lumen connected to the cannulation; wherein the elongate insertion shaft comprises a sheath surrounding the shaft.
  • the biopsy instrument comprises a needle comprising: a pointed tip having a cannulation; and a shaft extending form the pointed tip and having a lumen connected to the cannulation; wherein the elongate insertion shaft comprises a sheath surrounding the shaft.
  • Example 16 the subject matter of any one or more of Examples 11-15 optionally include wherein the biopsy probe further comprises: a control handle attached to a proximal end portion of the elongate insertion shaft; and one or more user interface components for controlling electrical output of the electrical generator.
  • the control handle further comprises: a fluid coupler configured to attach to a biopsy gel cartridge; and a fluid passage extending from the fluid coupler to the biopsy probe.
  • Example 18 the subject matter of any one or more of Examples 11-17 optionally include wherein the biopsy probe comprises an electrode tip shaped to penetrate tissue and the electrode tip comprises a non-stick coating.
  • Example 19 the subject matter of any one or more of Examples 11-18 optionally include a sheath connected to the elongate insertion shaft configured to be translated to cover and uncover the biopsy instrument.
  • Example 20 the subject matter of any one or more of Examples 11-19 optionally include a cooling circuit in communication with the biopsy instrument.
  • Example 21 is a method of adhering tissue to a medical instrument during a biopsy procedure, the method comprising: inserting the medical instrument into an anatomic location to reach target tissue; applying a first voltage having a first polarity to the medical instrument to cause electro-adhesion of at least a portion of the target tissue to the medical instrument; and withdrawing the medical instrument from the anatomic location to pull the portion of the target tissue from the anatomic location.
  • Example 22 the subject matter of Example 21 optionally includes wherein causing electro-adhesion of the portion of the target tissue to the medical instrument comprises sharing atomic bonds between the medical instrument and the target tissue.
  • Example 23 the subject matter of any one or more of Examples 21-22 optionally include applying a second voltage having a second polarity opposite the first polarity to the target tissue to release the target tissue from the medical instrument.
  • Example 24 the subject matter of Example 23 optionally includes wherein applying the first voltage and applying the second voltage each comprise applying a voltage in a range of approximately five volts to approximately ten volts.
  • Example 25 the subject matter of any one or more of Examples 23-24 optionally include wherein inserting the medical instrument into the anatomic location comprises electrically activating the medical instrument to cut tissue before applying the first voltage.
  • Example 26 the subject matter of any one or more of Examples 24-25 optionally include wherein electrically activating the medical instrument comprises applying a voltage greater than approximately two-hundred volts.
  • electrically activating the medical instrument comprises applying an electro-surgical voltage to a distal portion of the head of the medical instrument.
  • Example 28 the subject matter of any one or more of Examples 21-27 optionally include introducing a gel between the medical instrument and the target tissue before applying the first voltage.
  • Example 29 the subject matter of Example 28 optionally includes wherein injecting the gel defines a boundary for the target tissue to be withdrawn from the anatomic location.
  • Example 30 the subject matter of any one or more of Examples 21-29 optionally include covering the target tissue with a containment sheath before withdrawing the target tissue.
  • Example 31 the subject matter of any one or more of Examples 21-30 optionally include cooling the medical instrument before withdrawing the target tissue.
  • Numerical ranges recited herein by endpoints include all numbers and fractions subsumed within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.90, 4, 4.24, and 5). Similarly, numerical ranges recited herein by endpoints include subranges subsumed within that range (e.g., 1 to 5 includes 1 - 1.5, 1.5 - 2, 2 - 2.75, 2.75 - 3, 3 - 3.90, 3.90 - 4, 4 - 4.24, 4.24 - 5, 2 - 5, 3 - 5, 1 - 4, and 2 - 4). It is also to be understood that all numbers and fractions thereof are presumed to be modified by the term “about” or “approximately.”

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Abstract

Une sonde de biopsie comprend une gaine comprenant une lumière interne, un instrument de biopsie comprenant une tête pour percer un tissu, et un dispositif de commande pour commander l'application d'énergie électrique à l'instrument de biopsie. Un générateur électrique peut appliquer une première tension à l'instrument de biopsie à une première polarité pour provoquer l'adhérence du tissu à l'instrument de biopsie et appliquer une seconde tension à l'instrument de biopsie à une seconde polarité pour provoquer le détachement du tissu. Un procédé d'adhérence de tissu à un instrument médical pendant une procédure de biopsie consiste à insérer l'instrument médical à un emplacement anatomique pour atteindre un tissu, à appliquer une première tension ayant une première polarité à l'instrument médical pour provoquer l'électro-adhérence d'au moins une partie du tissu à l'instrument médical, et à retirer l'instrument médical de l'emplacement anatomique pour sortir la partie du tissu à partir de l'emplacement anatomique.
PCT/US2025/029769 2024-05-17 2025-05-16 Dispositif médical électro-adhésif pour récupération de tissu Pending WO2025240864A1 (fr)

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US63/649,099 2024-05-17

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7309316B1 (en) * 2004-03-01 2007-12-18 Flynn Edward R Magnetic needle biopsy
US20100191083A1 (en) * 2006-10-04 2010-07-29 President And Fellows Of Harvard College Engineered conductive polymer films to mediate biochemical interactions
US20100324446A1 (en) * 2009-06-18 2010-12-23 Vance Products Incorporated, D/B/A Cook Orolgoical Incorporated Telescoping Biopsy Device
US20190321016A1 (en) * 2010-03-26 2019-10-24 Histologics, LLC Frictional tissue sampling and collection method and device
US20230050625A1 (en) * 2020-04-28 2023-02-16 The Uab Research Foundation Coil wire for navigation in vascular tortuosity and methods of using the coil wire
US20240008876A1 (en) * 2022-07-08 2024-01-11 Gyrus Acmi, Inc. D/B/A Olympus Surgical Technologies America Electrostatic delivery of surgical material

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7309316B1 (en) * 2004-03-01 2007-12-18 Flynn Edward R Magnetic needle biopsy
US20100191083A1 (en) * 2006-10-04 2010-07-29 President And Fellows Of Harvard College Engineered conductive polymer films to mediate biochemical interactions
US20100324446A1 (en) * 2009-06-18 2010-12-23 Vance Products Incorporated, D/B/A Cook Orolgoical Incorporated Telescoping Biopsy Device
US20190321016A1 (en) * 2010-03-26 2019-10-24 Histologics, LLC Frictional tissue sampling and collection method and device
US20230050625A1 (en) * 2020-04-28 2023-02-16 The Uab Research Foundation Coil wire for navigation in vascular tortuosity and methods of using the coil wire
US20240008876A1 (en) * 2022-07-08 2024-01-11 Gyrus Acmi, Inc. D/B/A Olympus Surgical Technologies America Electrostatic delivery of surgical material

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