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WO2025198858A1 - Système et procédé de mise en place d'un dispositif vasculaire - Google Patents

Système et procédé de mise en place d'un dispositif vasculaire

Info

Publication number
WO2025198858A1
WO2025198858A1 PCT/US2025/018614 US2025018614W WO2025198858A1 WO 2025198858 A1 WO2025198858 A1 WO 2025198858A1 US 2025018614 W US2025018614 W US 2025018614W WO 2025198858 A1 WO2025198858 A1 WO 2025198858A1
Authority
WO
WIPO (PCT)
Prior art keywords
pressure pulse
distal tip
location
optical fiber
vasculature
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/US2025/018614
Other languages
English (en)
Inventor
Shayne Messerly
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.)
Bard Access Systems Inc
Original Assignee
Bard Access Systems Inc
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 Bard Access Systems Inc filed Critical Bard Access Systems Inc
Publication of WO2025198858A1 publication Critical patent/WO2025198858A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; Determining position of diagnostic devices within or on the body of the patient
    • A61B5/061—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0082—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes
    • A61B5/0084—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes for introduction into the body, e.g. by catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0093—Detecting, measuring or recording by applying one single type of energy and measuring its conversion into another type of energy
    • A61B5/0095—Detecting, measuring or recording by applying one single type of energy and measuring its conversion into another type of energy by applying light and detecting acoustic waves, i.e. photoacoustic measurements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • 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

Definitions

  • the placement of the vascular device such as a central catheter commonly requires the distal tip to be placed at a specific location within the patient vasculature, such as the lower one-third of the superior vena cava or the cavoatrial junction, for example. Misplacement of the catheter tip may result in risk to the patient or reduced effectiveness of the catheter procedure. In some instances of misplacement, replacement of the catheter may be required resulting in further risk to the patient and increased medical expense.
  • Ultrasound imaging can be utilized to provide guidance during placement of the placement of the vascular device.
  • Photoacoustic imaging is a medical imaging technique that combines principles from both optics and acoustics to visualize structures within biological tissues with high resolution and contrast.
  • One of the notable advantages of photoacoustic imaging is its ability to provide imaging depth and contrast comparable to general ultrasound imaging, while also offering the high resolution associated with optical imaging.
  • an elongate medical device configured for insertion into a patient, where the elongate medical device includes an optical fiber extending along the elongate medical device, where a distal tip the optical fiber is configured to project a light pulse away from the optical fiber.
  • a sensor module is configured for placement on a skin surface of the patient, where the sensor module includes a number of transducers configured to detect at the skin surface a pressure pulse resulting from the light pulse.
  • a system module includes a console operatively coupled with the optical fiber and the sensor module.
  • the console includes a processor and a memory having logic stored thereon that, when executed by the processor, performs operations of the system.
  • the operations include (i) activating a light source of the console to define the light pulse; (ii) detecting by the sensor module the pressure pulse resulting from the light pulse; (iii) converting a pressure pulse signal from the sensor module into pressure pulse data; and (iv) processing the pressure pulse data to determine therefrom properties of anatomical elements within a proximity of the distal tip.
  • activating the light source includes defining laser light pulses at one or more defined frequencies within the 20 kHz to 500 MHz, the laser light pulses having one or more wavelengths within the range of 700 nm and 1100 nm.
  • determining the properties includes obtaining an image of the anatomical elements, and the operations further include depicting the image on a display of the system. In some embodiments, depicting the image includes indicating in the image a location of the distal tip in relation to the anatomical elements.
  • processing the pressure pulse data includes determining a magnitude of the pressure pulse, and the pressure pulse state is defined at least partially by the magnitude. In some embodiments, processing the pressure pulse data includes determining a time delay of the pressure pulse with respect to the light pulse, and the pressure pulse state is defined at least partially by the time delay.
  • activating the light source includes defining a series of light pulses at a defined frequency, and converting the pressure pulse signal includes converting a series of pressure pulses signals resulting from the series of light pulses into the pressure pulse data.
  • the elongate medical device is configured for advancement along a vasculature of the patient, and the distal tip the optical fiber is configured to project the light pulse radially outward from the optical fiber.
  • the operations further include continually processing the pressure pulse data during advancement of the elongate medical device along the vasculature such that the distal tip is displaced from a first location within the vasculature to a second location within the vasculature, where the vasculature includes a first cross-sectional size at the first location and a second cross-sectional size at the second location, and where the second cross-sectional size is larger than the first cross-sectional size.
  • processing the pressure pulse data during advancement includes defining a first pressure pulse state when the distal tip is located at the first location, where the first pressure pulse state is defined at least partially by the first cross-sectional size, and defining a second pressure pulse state when the distal tip is located at the second location, where the second pressure pulse state is defined at least partially by the second cross-sectional size.
  • the operations further include providing a notification to the user when the first pressure pulse state transitions to the second pressure pulse state, and in some embodiments, the notification includes depicting indicia on a display of the system, where the indicia indicates a state change from the first pressure pulse state to the second pressure pulse state.
  • the system further includes a navigational sensor module coupled with the console that includes a plurality of sensor modules spaced away from each other on the patient, and the operations further include (i) detecting by each of the plurality of sensor modules the pressure pulse, (ii) converting pressure pulse signals from each of the plurality of sensor modules into the pressure pulse data; and (iii) continually processing the pressure pulse data utilizing navigation techniques to determine the location of the distal tip with respect to the navigational sensor module.
  • Also disclosed herein is a method that, according to some embodiments, includes (i) projecting a light pulse away from a distal tip of the optical fiber, the distal tip disposed within a patient; (ii) detecting a pressure pulse at a skin surface of the patient, the pressure pulse resulting from the light pulse; (iii) converting a pressure pulse signal into pressure pulse data for processing by logic executed by a processor; (iv) processing the pressure pulse data to define therefrom a pressure pulse state, where the pressure pulse state is related to a location of the distal tip.
  • processing the pressure pulse data includes determining a magnitude of the pressure pulse, and the pressure pulse state is defined at least partially by the magnitude. In some embodiments of the method, processing the pressure pulse data includes determining a time delay of the pressure pulse with respect to the light pulse, and the pressure pulse state is defined at least partially by the time delay.
  • project the light source includes projecting a series of light pulses at a defined frequency and converting the pressure pulse signal includes converting a series of pressure pulses signals resulting from the series of light pulses into the pressure pulse data.
  • the optical fiber is advanced along a vasculature of the patient, and the distal tip portion the optical fiber is configured to project the light pulse radially outward from the optical fiber.
  • the method further includes continually processing the pressure pulse data during advancement of the optical fiber along the vasculature such that the distal tip is displaced from a first location within the vasculature to a second location within the vasculature, where the vasculature includes a first cross-sectional size at the first location and a second cross-sectional size at the second location, and where the second cross-sectional size is larger than the first cross-sectional size.
  • continually processing the pressure pulse data during advancement includes defining a first pressure pulse state when the distal tip is located at the first location, where the first pressure pulse state defined at least partially by the first cross-sectional size, and defining a second pressure pulse state when the distal tip is located at the second location, where the second pressure pulse state defined at least partially by the second cross-sectional size.
  • the method further includes providing a notification to the user when the first pressure pulse state transitions to the second pressure pulse state.
  • the method further includes (i) continually processing the pressure pulse data during insertion of the catheter into the patient such that the distal tip is displaced from a first depth to a second depth; (ii) defining a third pressure pulse state when the distal tip is disposed at the first depth; (iii) defining a fourth pressure pulse state when the distal tip is disposed at the second depth; and (iv) providing a notification to the user when the third pressure pulse state transitions to the fourth pressure pulse state.
  • the optical fiber is slidably disposed within a lumen of a catheter
  • the method further comprises (i) continually processing the pressure pulse data during displacement of the catheter with respect to the optical fiber such that the distal tip is displaced from beyond a distal end of the catheter to within the lumen of the catheter; (ii) defining a fifth pressure pulse state when the distal tip is disposed beyond the distal end of the catheter; (iii) defining a sixth pressure pulse state when the distal tip is disposed within the lumen; and (iv) providing a notification to the user when the fifth pressure pulse state transitions to the sixth pressure pulse state indicating that the catheter covers the distal tip.
  • FIG. 1 illustrates a device tracking system that incorporates photo acoustic functionality, in accordance with some embodiments.
  • FIG. 2 illustrates a functional model of the system of FIG. 1 including exemplary photo-acoustic properties, in accordance with some embodiments.
  • FIG. 3 illustrates one exemplary implementation of the system of FIG. 1, in accordance with some embodiments.
  • FIG. 4 illustrates one other exemplary implementation of the system of FIG. 1, in accordance with some embodiments.
  • FIG. 5 is a block diagram of a method of providing guidance to a user during placement of a vascular device within a patient, in accordance with some embodiments.
  • phrases “connected to,” “coupled with,” and “in communication with” refer to any form of interaction between two or more entities, including but not limited to mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction.
  • Two components may be coupled with each other even though they are not in direct contact with each other.
  • two components may be coupled with each other through an intermediate component.
  • proximal and distal refer to opposite ends of a medical device, including the devices disclosed herein.
  • the proximal portion of a medical device is the portion nearest a practitioner during use, while the distal portion is the portion at the opposite end.
  • the distal end of medical device is defined as the end closest to the patient or furthest inserted into the patient during utilization of the medical device.
  • the proximal end is the end opposite the distal end.
  • logic may be representative of hardware, firmware or software that is configured to perform one or more functions.
  • logic may refer to or include circuitry having data processing and/or storage functionality. Examples of such circuitry may include, but are not limited or restricted to, a hardware processor (e.g., microprocessor, one or more processor cores, a digital signal processor, a programmable gate array, a microcontroller, an application specific integrated circuit “ASIC”, etc.), a semiconductor memory, or combinatorial elements.
  • a hardware processor e.g., microprocessor, one or more processor cores, a digital signal processor, a programmable gate array, a microcontroller, an application specific integrated circuit “ASIC”, etc.
  • ASIC application specific integrated circuit
  • logic may refer to or include software such as one or more processes, one or more instances, Application Programming Interface(s) (API), subroutine(s), function(s), applet(s), servlet(s), routine(s), source code, object code, shared library/dynamic link library (dll), or even one or more instructions.
  • API Application Programming Interface
  • subroutine(s) subroutine(s)
  • function(s) function(s)
  • applet(s) servlet(s)
  • routine(s) routine(s)
  • source code object code
  • shared library/dynamic link library e.g., shared library/dynamic link library (dll)
  • dll shared library/dynamic link library
  • This software may be stored in any type of a suitable non-transitory storage medium, or transitory storage medium (e.g., electrical, optical, acoustical or other form of propagated signals such as carrier waves, infrared signals, or digital signals).
  • non-transitory storage medium may include, but are not limited or restricted to a programmable circuit; non-persistent storage such as volatile memory (e.g., any type of random access memory “RAM”); or persistent storage such as non-volatile memory (e.g., read-only memory “ROM”, power-backed RAM, flash memory, phase-change memory, etc.), a solid-state drive, hard disk drive, an optical disc drive, or a portable memory device.
  • volatile memory e.g., any type of random access memory “RAM”
  • persistent storage such as non-volatile memory (e.g., read-only memory “ROM”, power-backed RAM, flash memory, phase-change memory, etc.), a solid-state drive, hard disk drive, an optical disc drive, or a portable memory device.
  • the logic may be stored in persistent storage.
  • Any methods disclosed herein include one or more steps or actions for performing the described method.
  • the method steps and/or actions may be interchanged with one another.
  • the order and/or use of specific steps and/or actions may be modified.
  • sub-routines or only a portion of a method described herein may be a separate method within the scope of this disclosure. Stated otherwise, some methods may include only a portion of the steps described in a more detailed method.
  • all embodiments disclosed herein are combinable and/or interchangeable unless stated otherwise or such combination or interchange would be contrary to the stated operability of either embodiment.
  • Photoacoustic imaging is a medical imaging technique that combines principles from both optics and acoustics to visualize structures within biological tissues with high resolution and contrast.
  • This imaging modality relies on the photoacoustic effect, where short pulses of light e.g., (laser light) are directed into biological tissues. Upon absorption of these light pulses, the tissue undergoes rapid thermal expansion, generating ultrasound waves or acoustic signals. These signals are then detected by ultrasound transducers at the skin surface. The detected signals are subsequently processed to reconstruct detailed images that reveal both anatomical and functional information, including properties of anatomical elements beneath the skin surface.
  • One of the notable advantages of photoacoustic imaging is its ability to provide imaging depth and contrast comparable to general ultrasound imaging, while also offering the high resolution associated with optical imaging. The choice of laser wavelength can be tailored to target specific subcutaneous structures.
  • Photoacoustic imaging utilizes a range of wavelengths of light, and wavelength may be chosen in accordance with desired imaging depth and specificity. An optimal wavelength may be partially based optical absorption characteristics of the target structures within the tissue. Common wave lengths include Near-Infrared (NIR) Range (700 nm - 1100 nm) and Extended Near-Infrared (NIR-II) Range (1100 nm - 1350 nm).
  • NIR Near-Infrared
  • NIR-II Extended Near-Infrared
  • the frequency spectrum of the photoacoustic signals can be used to extract data about the size and composition of the anatomical structures.
  • the sound wave frequency is defined by the characteristics of the acoustic signals generated by the photoacoustic effect.
  • the frequency spectrum of the photoacoustic signals is often analyzed using signal processing techniques, such as Fourier analysis. This decomposition of the signals into their constituent frequencies so that information about the size, composition, and depth of the anatomical structures can be extracted from the photoacoustic signals.
  • the medical devices can be any medical device configured for placement within the body at any location within the body.
  • the embodiments described below are just some exemplary none-limiting implementations of the photo-acoustic effect of many more implementation that could be contemplated by one of ordinary skill.
  • FIG. 1 illustrates a device tracking system (system) 100 that incorporates at least partially the photo-acoustic processes described above, in accordance with some embodiments.
  • the system 100 is generally configured to enable a clinician to place a distal end of an elongate medical device (e.g., a catheter) at a defined location within a vasculature of the patient 50.
  • the system 100 generally includes the elongate medical device (device) 150 and a sensor module 170, each of which are operatively coupled with a system module 110 and having a console 115.
  • the sensor module 170 and the system module 110 are separate modules operatively coupled to each other.
  • the sensor module 170 and the system module 110 may be combined into a single module, e.g., the console 115 and other components of the system module 110 may be incorporated into the sensor module 170.
  • the device 150 may include any elongate device configured for insertion into the patient 50 such as through the skin or via a body orifice, e.g., throat, anal canal, or urethra.
  • the device 150 includes a vascular device, such as a stylet, a guidewire or a catheter, for example.
  • An optical fiber 160 extends along the device 150.
  • a distal tip 161 of the optical fiber 160 may be positioned adjacent a distal end 151 of the device 150.
  • distal tip 161 of the optical fiber 160 may extend distally away from distal end 151.
  • the optical fiber 160 may be embedded into the device 150 such as embedded within the wall of catheter, for example.
  • the optical fiber 160 may be slidably coupled with the medical device 150 such that the optical fiber 160 is longitudinally positionable with respect to the device 150.
  • the optical fiber 160 may be slidably disposed within a lumen of the medical device 150, e.g., a lumen of the catheter.
  • the optical fiber 160 may be coupled with or incorporated into a guidewire configured for advancement along the vascular and the guidewire may be disposed within the lumen of the catheter.
  • the distal tip 161 of the optical fiber 160 may be positionable with respect to the distal end 151 of the device 150, e.g., disposed within the lumen or extended beyond the distal end 151.
  • the optical fiber 160 may be coupled with an optical cable 163 via an optical connector 164, where the optical connector 164 enables the optical fiber 160 to be selectively coupled with and decoupled from the optical cable 163.
  • the optical fiber 160 is optically coupled with the console 115 via the optical cable 163 and the optical cable 163 may be physically (e.g., permanently) attached to the system module 110.
  • the device 150 and/or the optical fiber 160 may be configured for single use or multi-use.
  • the sensor module 170 is configured for placement on the patient 50 such that the sensor module 170 is sonically coupled with the skin surface 51.
  • the sensor module 170 is generally configured to detect pressure pulses 174 (i.e., sound waves including ultrasonic waves) at a skin surface 51 of the patient 50.
  • the sensor module 170 may detect the pressure pulses at the skin surface 51.
  • the sensor module 170 may include or be composed of an ultrasound probe.
  • the sensor module 170 includes a number of transducers 172 (e.g., piezo-electric ultrasound transducers) disposed along a patient contact surface 173 of the sensor module 170.
  • the transducers 172 may define a onedimensional or two-dimensional array extending across the patient contact surface 173.
  • the sensor module 170 is operatively coupled with the console 115 via an electrical cable 176.
  • the console 115 includes components that generally define the operation of the system 100. It can be appreciated that the console 115 can take one of a variety of forms.
  • a processor 116 and memory 120 may be combined in a single device, such as an EEPROM, for example.
  • the processor 116 and memory 120 control system function during operation of the system module 110.
  • the memory 220 includes pulse control logic 121 and pulse processing logic 122.
  • a digital controller/analog interface 175 is also included with the console 115 and is in communication with the processor 210 and other system components.
  • the light 165 may include a preferred wavelength or multiple preferred wavelengths, such as wavelengths between 700 nm and 1100 nm.
  • the light source 161 may include a laser that defines the wavelength(s) of the light 165, such as laser diode, for example.
  • a laser diode may include a semiconductor device similar to a light-emitting diode in which a diode pumped directly with electrical current can create lasing conditions at the diode's junction.
  • the optical fiber 160 may include a fiber laser that defines the wavelength(s) of the light 165, where the fiber laser is excited by the light source 161.
  • a fiber laser is a laser in which the active gain medium is an optical fiber doped with rare-earth elements such as erbium, ytterbium, neodymium, dysprosium, praseodymium, thulium and holmium.
  • rare-earth elements such as erbium, ytterbium, neodymium, dysprosium, praseodymium, thulium and holmium.
  • the console 115 can further include a plurality of ports 117 for connection with optional components 119 including a printer, storage media, keyboard, etc.
  • the ports 117 in one embodiment may include USB ports, though other port types or a combination of port types can be used for this and the other interface connections described herein.
  • the console 115 may include a wireless module 118 to enable wireless communication over a network.
  • the console 115 may also include a display 112 (e.g., a graphical user interface) configured to provide notification to the user.
  • the display 112 may also be configured to receive input from the user.
  • a power connection 131 may be included with the console 115 to enable operable connection to an external power supply 132.
  • An internal power supply 133 e.g., a battery
  • Power management circuitry 130 is included to regulate power use and distribution.
  • the pulse control logic 121 is generally configured to control the optical operation of the optical fiber 160.
  • the optical fiber 160 is configured to receive the light 165 from the light source 161, propagate the light 165 along the optical fiber 160 to the distal tip 161, and project the light 165 outward (including radially outward) from the optical fiber 160.
  • the light 165 is projected onto anatomical elements of the patient 50.
  • the light 165 is projected through the blood 61 of the blood vessel 60 onto and through the blood vessel wall 62. Energy from the light 165 causes the blood vessel wall 62 and other surrounding anatomical elements according to expand or otherwise change shape, e.g., due to heating as a result of the light 165.
  • the expansion of the blood vessel wall 62 and surrounding anatomical elements defines a localized pressure change within the patient 50.
  • the light source 161 generates a light pulse that propagates along the optical fiber 160 projects onto the blood vessel wall 62 and surrounding anatomical elements.
  • the blood vessel wall 62 and surrounding anatomical elements expand in response to the light pulse which generates a pressure pulse 174.
  • the pressure pulse 174 propagates to the skin surface 51 where the sensor module 170 detects the pressure pulse 174 via the transducers 712.
  • the pulse processing logic 122 receives pressure pulse data from the digital controller/analog interface 175 and processes the pressure pulse data.
  • the pulse control logic 121 may define a series of light pulses in accordance with a defined pulse rate or frequency.
  • the frequency may include a frequency range of 20 kilohertz to 500 megahertz or more narrowly a range of 2 megahertz to 18 megahertz
  • the pulse control logic 121 may also define a pulse duration, i.e., an “on” time of each pulse. More specifically, the pulse control logic 121 may define a duty cycle of the light pulses, where the duty cycle is the percent “on” time for the light pulses. In some embodiments, the duty cycle may be between 5 and 50 percent.
  • the pulse control logic 121 defines light pulses at the defined frequency or frequencies
  • the blood vessel wall 62 vibrates at the defined frequency and generates sound waves that propagate to the skin surface 51.
  • the pulse processing logic 122 analyzes the sound waves via photo-acoustic techniques to obtain an image of the blood vessel 60 and the surround anatomical elements (e.g., the vasculature) based on the sound waves (pressure pulses).
  • the pulse processing logic 122 may also determine from the sound waves properties of the blood vessel 60 as further described below.
  • FIG. 2 illustrates a non-limiting model of the exemplary photo-acoustic functionalities of the system 100, according to some embodiments.
  • the blood vessel 60 is shown, where a size of the blood vessel 60 includes a first diameter 206A, a second diameter 206B, and third diameter 206C.
  • the second diameter 206B is greater than the first diameter 206A and the third diameter 206C is greater than the second diameter 206B.
  • the optical fiber 160 is shown at three positions such that the distal tip 161 having the light 165 projected radially outward therefrom is disposed at a first position 205A, a second position 205B and a third position 205B in accordance with the first diameter 206A, the second diameter 206B, and the third diameter 206C.
  • the sensor module 170 in contact with skin surface 51, is also positioned in alignment with the first position 205A, a second position 205B and a third position 205B of the distal tip 161.
  • the blood vessel 260 is located at a first, second, and third depth 207A-207C, respectively from the skin surface 51.
  • the light 165 travels through the blood 61 within the blood vessel 60 between the optical fiber 160 and the blood vessel wall 62, where the distance between the optical fiber 160 and the blood vessel wall 62 is related to the diameter of the blood vessel 60. Accordingly, in the illustrated model, the light 165 travels through the blood 61 a distance 209A at the first location 205A, a distance 209B at the second location 205B, and a distance 209C at the third location 205C. In some embodiments, the distance the light 165 travels through the blood 61 may affect (e.g., reduce) the energy of the light 165 received by the blood vessel wall 62 due to absorption of light energy by the blood 61. In more general terms, the diameter of the blood vessel 60 may affect the pressure pulse resulting from the light 165.
  • the light 165 causes the blood vessel wall 62 to change shape (e.g., expand or move) in response to the light 165 projected thereon due to a temperature change of the blood vessel wall 62 or other tissue in the proximity of the light projection.
  • the shape change causes a pressure pulse (i.e., a sound wave) to propagate through bodily tissue from the blood vessel wall 62 to the skin surface 51 at the speed of sound through the tissue.
  • the light 165 defines a corresponding first, second, and third pressure pulses 208A-208C, respectively.
  • the first pressure pulse 208A travels the distance 207A
  • the second pressure pulse 208B travels the distance 207B
  • the third pressure pulse 208C travels the distance 207C to the skin surface 51.
  • FIG. 2 further illustrates graphs 202A-202C that depict a various parameters of the pressure pulses 208A-208C, respectively, where the various parameters define a pressure pulse state.
  • Each graph shows a light pulse 210 as projected from the optical fiber 160 and a resulting pressure pulse state 211A-211C as detected by the sensor module 170.
  • Each graph includes an x-axis representing time and y-axis representing a magnitude (intensity) of the pressure pulse.
  • each pressure pulse state 211A-211C represents the parameters of the pressure pulses 208A-208C.
  • each pressure pulse state 211 A-211C may include a corresponding magnitude 212A-212C and a corresponding time delay 213A-213C.
  • other parameters of the pressure pulse are considered and may be included, such as a width of the pressure pulse a detected by different transducers 172 positioned at different locations, variations in the magnitude or time delay based on different wavelengths of the light 165 or different pulse frequencies, for example.
  • the parameters of the pressure pulse may include any subset of parameters typically included with photo-acoustic imaging
  • Graph 202A shows a magnitude 212A of the pressure pulse state 211 A that corresponds to or is at least partially defined by the diameter 206A and the graph 202C shows a magnitude 212C of the pressure pulse state 211C that corresponds to or is at least partially defined by the diameter 206C.
  • the magnitude 212A may be greater than the magnitude 212C.
  • the pulse processing logic 122 may detect difference in diameter between the diameter 206 A and the diameter 206C. More specifically, the pulse processing logic 122 determine a pressure pulse state in accordance with the diameter 206A that is different than a pressure pulse state in accordance with the diameter 206C.
  • the graph 202A shows a time delay 213 A of the pressure pulse response 211 A that corresponds to or is at least partially defined by the distance 207A and the graph 202B shows a time delay 213B of the pressure pulse response 211C that corresponds to or is at least partially defined by the distance 207B.
  • the time delay 213B may be greater than the time delay 213 A.
  • the pulse processing logic 122 may detect difference in distance between the distance 207A and the distance 207B. More specifically, the pulse processing logic 122 determine a pressure pulse state in accordance with the distance 207A that is different than a pressure pulse state in accordance with the distance 207B.
  • the user may advance the optical fiber 160 along the blood vessel 60 such that the distal tip 161 is displaced from the position 205 A to the position 205B.
  • the magnitude of the pressure pulse state transitions (e.g., decreases) from the magnitude 212A to the magnitude 212B as a result of the increase in diameter from the diameter 206 A to the diameter 206B.
  • the time delay of the pressure pulse state transitions (e.g., increases) from the time delay 213 A to the time delay 213B as a result of the increase in depth from the depth 207A to the depth 207B.
  • the user may advance the optical fiber 160 along the blood vessel 60 such that the distal tip 161 is displaced from the position 205B to the position 205C resulting in a change of the pressure pulse state.
  • the magnitude of the pressure pulse state transitions (e.g., decreases) from the magnitude 212B to the magnitude 212C as a result of the increase in diameter from the diameter 206B to the diameter 206C.
  • the time delay of the pressure pulse response transitions (e.g., decreases) from the time delay 213B to the time delay 213C as a result of the decrease in depth from the depth 207B to the depth 207C.
  • the time delay may be related to the total distance between the sensor module 170 and the distal tip 161 which may include a depth component and a lateral offset component.
  • FIG. 3 illustrates one exemplary implementation (e.g., an instance of use) of the system 100 in use with a patient 50, in accordance with some embodiments.
  • the system 100 is generally configured to enable a clinician to place the distal end 151 of device 150 at a defined location within a vasculature of the patient 50.
  • FIG. 3 further illustrates various exemplary elements of the patient 50.
  • a heart 360 of the patient 50 includes a right atrium 361.
  • a venous vasculature 370 includes a brachial vein 371, a subclavian vein 372, and a superior vena cava
  • the superior vena cava 373 couples with the right atrium 361 at the cavoatrial junction
  • the device 150 is configured for insertion within the venous vasculature 70 and may include any suitable medical device, such as a catheter, a stylet or guidewire, for example.
  • the device 150 is inserted into the brachial vein 371 at the insertion site 351.
  • the device 150 is advanced along the brachial vein 371, the subclavian vein 372, and the superior vena cava 373.
  • the distal end 151 (including the distal tip 161) is displaced from a first location 301 within the superior vena cava 373 to a second location 302 within the right atrium 61.
  • the distal end 151 is displaced across the cavoatrial junction 374 as the distal end 151 is displaced between the first location 301 the second location 302.
  • the right atrium 361 includes a greater cross- sectional area or diameter than the superior vena cava 373.
  • the cavoatrial junction 374 defines a transition between the cross-sectional area of the superior vena cava 373 and the cross-sectional area of the right atrium 361.
  • the sensor module 170 is placed on the skin surface 51 of the patient 50 to be located over the cavoatrial junction 374.
  • the size and shape of the sensor module 170 may vary in relation to the size and shape shown.
  • the sensor module 170 may be configured to cover larger portion of the patient 50.
  • the sensor module 170 is illustrated as transparent to allow details beneath the sensor module 170 to be shown.
  • the light 165 distal tip 161 is projected away from the distal tip 161 to excite (i.e., cause to vibrate) the body tissue in the proximity of the distal tip 161 such that the anatomical elements can be visualized as described.
  • pressure pulses sound waves
  • the pulse processing logic 122 may determine a location of the distal tip 161 by analyzing the vibration intensity (e.g., magnitude of the sound waves) since the vibration intensity can decrease with distance from the distal tip 165.
  • the image 308 may visually indicate the location 309 of the distal tip 161 as the device 150 is advanced along the vasculature 370. In this way, the user may visually track the location of the distal end 151 of the device 150 during advancement.
  • the pulse processing logic 122 may also cause a graph 310 to be depicted on the display 112, where the graph 310 indicates the pressure pulse state as described above in relation to FIG. 2.
  • the graph 112 indicates a (i) first pressure pulse state 311 consistent with the distal end 151 located at the first position 301 and (ii) a second pressure pulse state 312 consistent with the distal end 151 located at the second position 302.
  • the graph 112 transitions from the first pressure pulse state 311 to the second pressure pulse state 312 as the distal end 151 is displaced across the cavoatrial junction 374 from the superior vena cava 373 to the right atrium 361.
  • the graph 112 transitions from the second pressure pulse state 312 to the first pressure pulse state 312 as the distal end 151 is displaced across the cavoatrial junction 374 from the right atrium 361 to the superior vena cava 373.
  • the user can determine the position of the distal end 151 with respect to the cavoatrial junction 374 by distally advancing the device 150 with respect to the insertion site 351 and/or proximally retracting the device 150 with respect to the insertion site 351 while observing the graph 112 and noting the transitioning of the graph 112 between the first pressure pulse state 311 and the second pressure pulse state 312.
  • the device 150 may include a catheter having the optical fiber 160 slidably disposed within the lumen of the catheter. During advancement of the catheter (the device 150 including the optical fiber 160) and positioning of the distal tip 161, the distal tip 161 may be extended distally away for the distal end 151 of the catheter so that the light 165 may be projected radially away from the optical fiber 160. Once the distal tip 161 is finally positioned as described above, the user may distally displace the catheter with respect to the optical fiber 160 so as to finally position the distal end 151 of the catheter.
  • the catheter covers the distal tip 161, thereby inhibiting projection of the light 165 onto the blood vessel wall.
  • the pressure pulse state response is affected which may include a decrease in the magnitude of the pressure pulse state. In this way, the user may know that the distal end 151 is positioned at the same location as the distal tip 161.
  • FIG. 4 illustrates an exemplary device tracking system 400 in use with a patient 50 that may, in some respects, resemble the components and functions of the system 100, in accordance with some embodiments.
  • the system 400 is generally configured to enable a clinician to track the location of the distal end 151 of device 150 (which includes the distal tip 161) during advancement of the device 150 along the vasculature of the patient 50.
  • FIG. 4 further illustrates various exemplary elements of the patient 50 similar to FIG. 3.
  • the device 150 is inserted into the brachial vein 371 at the insertion site 351.
  • the device 150 including the distal tip 161 is advanced along the brachial vein 371, the subclavian vein 372, and the superior vena cava 373 to the right atrium 361.
  • a navigation sensor module 470 is placed on the skin surface 51 of the patient 50.
  • the navigation sensor module 470 includes a number of sensor modules spaced away from each other, such as the sensor modules 470A-470C, for example.
  • Each of the sensor modules 470A-470C may in some respects resemble the components and functionality of the sensor module 170.
  • the navigation sensor module 470 is illustrated as transparent to allow details beneath the navigation sensor module 470 to be shown. In accordance with the photo acoustic functionalities and parameters illustrated in FIG.
  • the device tracking system 400 is configured to determine the location of the distal tip 161 with respect to the navigation sensor module 470 and track the location of the distal tip 161 during advancement of the device 150 along the vasculature or at any other location within the patient 50 within a detectable proximity of the navigation sensor module 470.
  • the pulse processing logic 122 may process the pressure pulse data as similarly described above to determine a distance (through the patient) between distal tip 161 and each of the sensor modules 470A-470C.
  • the pulse processing logic 122 may further process the pressure pulse data utilizing navigational techniques (e.g., triangulated navigational techniques) to determine the location of the distal tip 161 with respect to the navigation sensor module 470.
  • navigational techniques e.g., triangulated navigational techniques
  • the location of the distal tip 151 with respect to the navigation sensor module 470 may be related to the location of the distal tip 151with respect to one or more anatomical elements of the patient 50, such as the heart, for example, as the device 150 is advanced along the vasculature.
  • An image depicted on the display 112 may include a representation of the navigation sensor module 471 and a location (or track) 451 of the distal tip 161 shown in relation to the representation of the navigation sensor module 471.
  • the user may determine the location of the distal tip 161 with respect to the navigation sensor module 470 by observing the image on the distal 112.
  • FIG. 5 is a block diagram of a method 500 that includes all or any subset of the following steps, operations, actions, or process, according to some embodiments.
  • the method 500 utilizes components of the device tracking system as performed by logic of the device tracking system.
  • the method 500 includes projecting a light pulse away from a distal tip of the optical fiber, where the distal tip is disposed within a patient (block 510).
  • the method 500 further includes detecting a pressure pulse at a skin surface of the patient, where the pressure pulse is a result of the light pulse (block 520)
  • the method 500 further includes converting a pressure pulse signal into pressure pulse data for processing by logic (block 530).
  • projecting the light includes projecting a series of light pulses
  • converting the pressure pulse signal includes converting a series of pressure pulses signals resulting from the series of light pulses into the pressure pulse data.
  • the method 500 further includes processing the pressure pulse data to define therefrom a pressure pulse state, where the pressure pulse state is related to a location of the distal tip (block 540).
  • processing the pressure pulse data includes determining a magnitude of the pressure pulse, and the pressure pulse state is defined at least partially by the magnitude.
  • processing the pressure pulse data includes determining a time delay of the pressure pulse with respect to the light pulse, and the pressure pulse state is defined at least partially by the time delay.
  • the optical fiber is advanced along a vasculature of the patient, and the distal tip portion the optical fiber is configured to project the light pulse radially outward from the optical fiber.
  • the method 500 further includes continually processing the pressure pulse data during advancement of the optical fiber along the vasculature, such that the distal tip is displaced from a first location within the vasculature to a second location within the vasculature, where the vasculature includes a first cross-sectional size at the first location and a second cross-sectional size at the second location, and where the second cross-sectional size is larger than the first cross-sectional size.
  • continually processing the pressure pulse data during advancement includes defining a first pressure pulse state when the distal tip is located at the first location, where the first pressure pulse state defined at least partially by the first cross-sectional size, and defining a second pressure pulse state when the distal tip is located at the second location, where the second pressure pulse state defined at least partially by the second cross-sectional size.
  • the method 500 further includes providing a notification to the user when the pressure pulse state transitions from first pressure pulse state transitions to the second pressure pulse state (block 550).
  • the method 500 further includes (i) continually processing the pressure pulse data during insertion of the catheter into the patient such that the distal tip is displaced from a first depth to a second depth; (ii) defining a third pressure pulse state when the distal tip is disposed at the first depth; (iii) defining a fourth pressure pulse state when the distal tip is disposed at the second depth; and (iv) providing a notification to the user when the third pressure pulse state transitions to the fourth pressure pulse state.
  • the optical fiber is slidably disposed within a lumen of a catheter, and the method further comprises (i) continually processing the pressure pulse data during displacement of the catheter with respect to the optical fiber such that the distal tip is displaced from beyond a distal end of the catheter to within the lumen of the catheter; (ii) defining a fifth pressure pulse state when the distal tip is disposed beyond the distal end of the catheter; (iii) defining a sixth pressure pulse state when the distal tip is disposed within the lumen; and (iv) providing a notification to the user when the fifth pressure pulse state transitions to the sixth pressure pulse state indicating that the catheter covers the distal tip.

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Abstract

La présente invention concerne un système médical qui comprend un dispositif vasculaire allongé ayant une fibre optique et un module de capteur conçu pour détecter des impulsions de pression à la surface de la peau obtenues au moyen d'impulsions de lumière projetées à partir d'une pointe distale de la fibre optique à l'intérieur du système vasculaire d'un patient. Une logique d'une console de système traite des données d'impulsion de pression à l'aide de techniques d'imagerie photo-acoustique pour obtenir une image du système vasculaire. Le traitement peut également comprendre la détermination des propriétés du système vasculaire, telles qu'une taille de section transversale du système vasculaire, et détermine à partir de celui-ci un emplacement de la pointe distale.
PCT/US2025/018614 2024-03-21 2025-03-05 Système et procédé de mise en place d'un dispositif vasculaire Pending WO2025198858A1 (fr)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20200229789A1 (en) * 2017-12-06 2020-07-23 Fujifilm Corporation Ultrasound diagnostic apparatus and method for controlling ultrasound diagnostic apparatus
US20230225793A1 (en) * 2020-06-18 2023-07-20 Koninklijke Philips N.V. Atherectomy guidance through photoacoustic signal analysis

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20200229789A1 (en) * 2017-12-06 2020-07-23 Fujifilm Corporation Ultrasound diagnostic apparatus and method for controlling ultrasound diagnostic apparatus
US20230225793A1 (en) * 2020-06-18 2023-07-20 Koninklijke Philips N.V. Atherectomy guidance through photoacoustic signal analysis

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