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WO2025002537A1 - Cathéter pour création par voie percutanée de fistule artérioveineuse et/ou mise en place automatique d'un fil-guide dans des vaisseaux concomitants - Google Patents

Cathéter pour création par voie percutanée de fistule artérioveineuse et/ou mise en place automatique d'un fil-guide dans des vaisseaux concomitants Download PDF

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Publication number
WO2025002537A1
WO2025002537A1 PCT/EP2023/067429 EP2023067429W WO2025002537A1 WO 2025002537 A1 WO2025002537 A1 WO 2025002537A1 EP 2023067429 W EP2023067429 W EP 2023067429W WO 2025002537 A1 WO2025002537 A1 WO 2025002537A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
cutting element
vein
guidewire
activatable
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/EP2023/067429
Other languages
English (en)
Inventor
Olivia Ruth PALMER
Sean WALL
Breanna SIMPSON
John O'shea
Andy MOLL
Kristin ROMINGER
Alex Palmer
Oladipo Peter AKERELE-ALE
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.)
ClearStream Technologies Ltd
Original Assignee
ClearStream Technologies Ltd
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 ClearStream Technologies Ltd filed Critical ClearStream Technologies Ltd
Priority to PCT/EP2023/067429 priority Critical patent/WO2025002537A1/fr
Publication of WO2025002537A1 publication Critical patent/WO2025002537A1/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

Links

Classifications

    • 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
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • 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
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00404—Blood vessels other than those in or around the heart
    • 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
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00601—Cutting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/378—Surgical systems with images on a monitor during operation using ultrasound
    • A61B2090/3782—Surgical systems with images on a monitor during operation using ultrasound transmitter or receiver in catheter or minimal invasive instrument
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3925—Markers, e.g. radio-opaque or breast lesions markers ultrasonic

Definitions

  • This disclosure relates to a catheter for percutaneously creating an arteriovenous fistula and/or guidewire placement by itself in concomitant vessels.
  • a system and device for the same are also disclosed.
  • a method for percutaneously creating an arteriovenous fistula in concomitant vessels is also disclosed.
  • Certain surgical procedures involve the creation of an arteriovenous fistula to connect an artery to a vein. For example, this may be performed in order for a patient to receive dialysis. By way of another example, this may be preformed for bypassing occluded arteries via a concomitant vein.
  • the catheter comprising: an elongate body dimensioned so as to be insertable into the vein, the elongate body comprising a proximal portion and a distal portion, the distal portion having an end portion; a lumen extending through the elongate body for accommodating a guidewire; the catheter further comprising: an activatable cutting element, wherein the distal portion comprises the activatable cutting element located at or in the vicinity of the end portion, wherein the cutting element is configured to deliver energy to a cutting site to create the fistula, wherein the activatable cutting element is arranged to be initially activated when the cutting element is located in the vein and before at least a portion of the cutting element is located the artery.
  • the catheter may allow a user to apply a forward mechanical force while the activatable cutting element is active, to aid in fistula creation.
  • the elongate body may be configured with sufficient rigidity to allow the user to push the catheter through the vessels, with sufficient flexibility to enable the tip to align with the vessel wall.
  • the cutting element may be arranged to be initially activated when the entire cutting element is disposed in the vein.
  • the cutting site may be located in the vein.
  • the cutting site may be a vein wall of the vein, and optionally, a portion of the vein wall closest to the concomitant artery.
  • the concomitant vessels may be substantially parallel to one another and/or adjacent to one another.
  • the concomitant vessels may abut one another.
  • the vein and artery may, by way of non-limiting example, be any of: the posterior tibial artery/vein, anterior tibial artery/vein, peroneal artery/vein, radial artery/vein, ulnar artery/vein, or brachial artery/vein.
  • the elongate body may have a degree of rigidity to allow the activatable cutting element to be pushed through the vessels during activation and have a degree of flexibility to enable the distal portion to bend so as to be in alignment with a wall of at least one of the vessels.
  • the catheter may be configured to create the fistula prior to advancing the catheter into the artery.
  • the catheter may have sufficient rigidity to enable a forward mechanical force to be applied to the catheter while the cutting element is activated.
  • This curved lumen may assist in aligning the activatable cutting element with the wall of the vessel where the fistula is to be created.
  • the guidewire may be relatively firmly fixed in place at the location where it crosses through the vein wall into the artery. When the distal end of the catheter advances close to this crossing location, the catheter may bend to directly face the wall of the vein at this location.
  • the activatable cutting element may circumscribe the guidewire and may form a fistula at a location centered upon the guidewire.
  • the cutting site may be at the location where the catheter accesses the artery to form the fistula at this location.
  • the end portion may be a tip of the catheter, i.e. a distalmost end of the catheter.
  • a cross-section of the activatable cutting element may be substantially the same as a cross-section of the distal portion of the elongate body. In this manner, elongate body may follow the activatable cutting element as it cuts further through from the vein to the artery.
  • the activatable cutting element may comprise an electrode, for example a single monopolar electrode.
  • the activatable cutting element may one of: one or more spoke electrodes, a spiral electrode; and/or one or more ring electrodes.
  • the catheter may comprise a power connection for applying energy, supplied from a power source, to the activatable cutting element.
  • the power connection may be disposed at the proximal portion.
  • the activatable cutting element may extend beyond and/or be flush with at least one of an outer surface of the elongate body and an inner surface of the elongate body.
  • the distal portion may comprise a tapered portion tapered towards and including the end portion.
  • the cutting element may be disposed on the tapered portion.
  • the distal portion may comprise a bent tip and the cutting element may be disposed on or in the bent tip, wherein the tip is bent so that the cutting element is placeable against a wall of the vein at the cutting site.
  • the cutting element may be formed on at least one of an end surface of the end portion and on a side surface of the end portion.
  • the distal portion may have a bevel shaped portion with respect to a central longitudinal axis of the elongate body.
  • the cutting element may be located on or in the bevel shaped portion.
  • the activatable cutting element (or at least a surface of the activatable cutting element) may be arranged at an angle to central longitudinal axis of the catheter.
  • the surface may be arranged approximately 45 degrees to the longitudinal central axis of the catheter.
  • the catheter may follow a curved (i.e. tortuous) path within the vein.
  • the aforementioned central longitudinal axis should therefore be determined locally over a relatively short section of the catheter at the end portion.
  • the cutting element may be diamond-shaped and surround the lumen.
  • the cutting element may be oval-shaped and surround the lumen.
  • a catheter for percutaneously creating an arteriovenous fistula by itself in concomitant vessels, the concomitant vessels being a vein and an artery comprising: an elongate body dimensioned so as to be insertable into the vein, the elongate body comprising a proximal portion and a distal portion, the distal portion having an end portion; a lumen extending through the elongate body for accommodating a guidewire; the catheter further comprising: an activatable cutting element, wherein the activatable cutting element is configured to be deployable and retractable through the lumen, wherein the cutting element is configured to deliver energy to a cutting site to create the fistula, wherein the activatable cutting element is arranged to be initially activated when the cutting element is located in the vein and before at least a portion of the cutting element is located the artery.
  • the cutting element may comprise an umbrella element having a plurality of spokes.
  • the catheter may further comprise a deployment element for deploying the umbrella.
  • the deployment (unfurling) and retraction (re-furling, after use) of the umbrella may be controlled manually by the user.
  • the deployment element may comprise a rigid push rod. This may allow a user to push an end of the rigid push rod that is outside the patient (e.g. on a handle connected to the catheter) to deploy the umbrella.
  • the umbrella may be configured to transition between a folded state, in which state the umbrella may fit within the lumen, and at least one of an expanded state and a partially expanded state.
  • a vessel e.g. vein
  • the activatable cutting element may be configured to be disabled while the umbrella is within the lumen. This may prevent damage to the catheter due to unintentional activation of the activatable cutting element.
  • the activatable cutting element may comprise one or more cutting electrodes.
  • the one or more spokes may constitute the one or more cutting electrodes. That is, the spokes may serve a dual purpose of providing shape to the umbrella (and deploying/furling it too) and providing the activatable cutting element.
  • the one or more spokes may be flexible.
  • the one or more spokes comprise nitinol wire.
  • a state of deployment of the umbrella may be manually or automatically adjustable. This state of deployment may, at least partially, depend on at least one of the location of the concomitant vessels and the dimensions of the concomitant vessels).
  • At least one of the distal portion and the end portion may comprise one or more visualisation aids, wherein the visualisation aids are configured to allow the catheter to be visualized by a detection device, for example, an ultrasound device.
  • a detection device for example, an ultrasound device.
  • the one or more visualisation aids may comprise one or more cutouts. That is, sections of the material of the catheter may be removed to provide a clearly-identifiable change in the outer profile of the catheter at a known location.
  • the catheter may comprise one or more reinforcement elements for reinforcing the catheter arranged to compensate for material absent in the one or more cutouts.
  • the one or more visualisation aids and/or the one or more reinforcement elements may be arranged circumferentially around the catheter.
  • the one or more electrodes is arranged to be deployed prior to the initial activation of the cutting element from a folded state of the umbrella element to an expanded or partially expanded state.
  • the guidewire may be deployable out of, and retractable through, the lumen.
  • the system may further comprise a needle element arranged to puncture through the vein and artery to allow the guidewire access to the artery.
  • the cutting element may then be arranged to expand the access region.
  • the system may further comprise: a non-invasive detection system for detecting the location of the catheter, in use.
  • the non-invasive detection system may be, for example, an ultrasound system.
  • a method for percutaneously creating an arteriovenous fistula in concomitant vessels the concomitant vessels being a vein and an artery.
  • the method comprises: inserting a guidewire percutaneously such that the guidewire extends from a vein into an artery; inserting a catheter over the guidewire and into the vein, the catheter comprising: an elongate body dimensioned so as to be insertable into the vein, the elongate body comprising a proximal portion and a distal portion, the distal portion having an end portion; a lumen extending through the elongate body for accommodating the guidewire; an activatable cutting element located at or in the vicinity of the end portion; the method further comprising: advancing the catheter along the guidewire until the end portion is adjacent a point where the guidewire exits the vein and enters into the artery; and activating the activatable cutting element and advancing the activatable cutting element along the guidewire to form a fistula between the vein
  • the catheter may be the catheter according to the first or second aspects.
  • the step of inserting a guidewire may include inserting a needle element through the skin, into the vein and through the vein into an artery; inserting the guidewire through the needle; and withdrawing the needle proximally over the guidewire. Withdrawing the needle may comprise leaving the guidewire in place while the needle is removed from the patient and then advanced proximally over the guidewire until the guidewire is no longer within the needle.
  • the method may further comprise deploying an umbrella that comprises the activatable cutting element from the lumen, and transitioning the umbrella from a furled state to an expanded or partially expanded state.
  • Figure 1A shows a schematic side-on view of a catheter penetrating a vein and an artery
  • Figure 1 B shows a plan view of the catheter penetrating a vein and an artery as depicted in Figure 1A;
  • Figure 2A shows a schematic side-on view of a sheath penetrating in the vein, and the catheter extending out from the sheath and along a guidewire;
  • Figure 2B shows a zoomed-in view of a distal end portion of the catheter
  • Figure 3A shows a perspective view of a tip of the catheter
  • Figure 3B shows a side-on view of the tip of the catheter of Figure 3A
  • Figure 4A shows a perspective view of another design of the tip of the catheter
  • Figure 4B shows the perspective view of Figure 4A with the guidewire extending out from the catheter
  • Figure 5A shows a perspective view of another design of the tip of the catheter
  • Figure 5B shows a cross-sectional side view of the catheter of Figure 5A
  • Figure 6 shows a catheter having an umbrella extendable from the tip
  • Figures 7A-D show various designs for cutting elements arranged on the umbrella
  • Figures 8A and 8B show an end portion of the catheter having cutouts
  • Figure 9 shows an end portion of the catheter having a metal braid over the cutout.
  • Figure 1A shows a schematic view of a concomitant vein 2 and artery 4.
  • the vein and artery could be any of the posterior tibial artery/vein, anterior tibial artery/vein, peroneal artery/vein, radial artery/vein, ulnar artery/vein, or brachial artery/vein.
  • a needle element comprising a needle 6 is used to insert a guidewire 8. To do this, the needle 6 is inserted percutaneously to penetrate first into the vein 2 and then into the artery 4.
  • the guidewire 8 is inserted, through the needle 6, into the artery 4 and the needle 6 is then removed.
  • the guidewire 8 remains in position, crossing out of the vein 2 at a location Z in the wall 2a of the vein 2 and then entering the artery 4.
  • Figure 1 B shows a different perspective of the schematic view of Fig 1 A.
  • FIG 2A shows a device 1 comprising, inter alia, a sheath 10 for introducing a catheter 12 into the vein 2.
  • the catheter 12 has an elongate body 14 having a proximal portion 16 (N.B. the proximal portion 16 of the catheter 12 is, in Figure 2A, located inside the sheath 10) and a distal portion 18.
  • the elongate body 14 forms a tube having a lumen 25 (shown in Figures 3A, 4A, 5A, etc.) Typically, the tube will have a substantially circular cross-section, but other cross-sections are envisaged.
  • a handle 3 comprising a steering element 3a for steering the distal portion 18 of the catheter 12.
  • the steering element 3a may comprise mechanical and/or pneumatic actuators.
  • the device 1 , the guidewire 8 and the catheter 12 constitute a system for creating an arteriovenous fistula.
  • the system may be considered to further comprise the needle element.
  • the system may further comprise a non-invasive detection system 50 for detecting the location of the catheter in use, such as an ultrasound system.
  • distal and proximal taken their usual meanings in the art. That is, the “distal” refers to parts/regions located furthest from the care provider and “proximal” refers to parts/regions closest to the care provider.
  • distal portion 18 of the catheter 12 may be located inside the patient’s vasculature (e.g. vein 2), while the proximal portion 16 may be outside the patient’s body and may be manipulated by a physician or other care provider.
  • the distal portion 18 has an end portion 20 and comprises an activatable cutting element 22 located at or in the vicinity of the end portion 20.
  • the activatable cutting element 22 is at a fixed position relative to the elongate body 14.
  • the activatable cutting element 22 may be formed in/integral with the elongate body 14 of the catheter 12.
  • the activatable cutting element 22 may be movable relative to the elongate body 14.
  • the activatable cutting element 22 may be initially stored within the elongate body 14 and then extended out therefrom before activation. Details of these various designs are discussed in further detail below.
  • the activatable cutting element 22 is for forming a fistula of a predetermined size between the vein 2 and artery 4 using an ablation technology.
  • the activatable cutting element 22 may, by way of non-limiting example, employ any of: radiofrequency, thermal, laser, microwave, and/or cryogenic ablation technologies for forming the fistula.
  • the activatable cutting element 22 may be connected to power source 60 outside the patient via a wire, lumen or fiber (not shown) running through the elongate body 14.
  • the power source 60 may provide, via a wire, electrical power having a radio frequency alternating current.
  • the power source 60 may provide laser energy along an optical fibre.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Plasma & Fusion (AREA)
  • Medical Informatics (AREA)
  • Otolaryngology (AREA)
  • Physics & Mathematics (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

La présente divulgation concerne un cathéter (12) permettant de créer par voie percutanée une fistule artérioveineuse et/ou de placer automatiquement un fil-guide dans des vaisseaux concomitants, les vaisseaux concomitants étant une veine (2) et une artère (4). Le cathéter comprend : un corps allongé (14) dimensionné de façon à pouvoir être inséré dans la veine, le corps allongé comprenant une partie proximale (16) et une partie distale (18), la partie distale comportant une partie d'extrémité (20) ; et une lumière (25) s'étendant à travers le corps allongé pour recevoir un fil-guide (8). Le cathéter comprend en outre un élément de coupe activable (22) doté d'une surface coupante (22a). La partie distale peut comprendre l'élément de coupe activable situé sur la partie d'extrémité ou à proximité de celle-ci, l'élément de coupe étant conçu pour fournir de l'énergie à un site de coupe pour créer la fistule, l'élément de coupe activable étant conçu pour être initialement activé lorsqu'il est situé dans la veine, et avant qu'au moins une partie de l'élément de coupe soit située dans l'artère. En variante, l'élément de coupe activable (22) peut être configuré pour être déployé et rétracté à travers la lumière (25), l'élément de coupe étant configuré pour fournir de l'énergie à un site de coupe afin de créer la fistule, l'élément de coupe activable étant conçu pour être initialement activé lorsqu'il est situé dans la veine, et avant qu'au moins de ses parties se trouve dans l'artère. L'invention concerne également un dispositif comprenant le cathéter et un système comprenant le dispositif.
PCT/EP2023/067429 2023-06-27 2023-06-27 Cathéter pour création par voie percutanée de fistule artérioveineuse et/ou mise en place automatique d'un fil-guide dans des vaisseaux concomitants Pending WO2025002537A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/EP2023/067429 WO2025002537A1 (fr) 2023-06-27 2023-06-27 Cathéter pour création par voie percutanée de fistule artérioveineuse et/ou mise en place automatique d'un fil-guide dans des vaisseaux concomitants

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2023/067429 WO2025002537A1 (fr) 2023-06-27 2023-06-27 Cathéter pour création par voie percutanée de fistule artérioveineuse et/ou mise en place automatique d'un fil-guide dans des vaisseaux concomitants

Publications (1)

Publication Number Publication Date
WO2025002537A1 true WO2025002537A1 (fr) 2025-01-02

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PCT/EP2023/067429 Pending WO2025002537A1 (fr) 2023-06-27 2023-06-27 Cathéter pour création par voie percutanée de fistule artérioveineuse et/ou mise en place automatique d'un fil-guide dans des vaisseaux concomitants

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006057920A2 (fr) * 2004-11-22 2006-06-01 Rox Medical, Inc. Dispositifs, systemes et procedes de fabrication d'une fistule arterio-veineuse actionnee par energie
US20110306993A1 (en) * 2010-06-15 2011-12-15 Baja Research , Llc. Systems and methods for creating arteriovenous (av) fistulas
WO2011159825A1 (fr) * 2010-06-15 2011-12-22 Caymus Medical, Inc. Anastomose intravasculaire d'une artère à une veine, et cathéter pour soudage de tissu
US20120232326A1 (en) * 2009-11-04 2012-09-13 Nagy Habib Lumenal remodelling device and methods
WO2018213626A1 (fr) * 2017-05-17 2018-11-22 Avenu Medical, Inc. Système de découpe de tissu par électrode de cathéter unique destiné à créer des anastomoses

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006057920A2 (fr) * 2004-11-22 2006-06-01 Rox Medical, Inc. Dispositifs, systemes et procedes de fabrication d'une fistule arterio-veineuse actionnee par energie
US20120232326A1 (en) * 2009-11-04 2012-09-13 Nagy Habib Lumenal remodelling device and methods
US20110306993A1 (en) * 2010-06-15 2011-12-15 Baja Research , Llc. Systems and methods for creating arteriovenous (av) fistulas
WO2011159825A1 (fr) * 2010-06-15 2011-12-22 Caymus Medical, Inc. Anastomose intravasculaire d'une artère à une veine, et cathéter pour soudage de tissu
WO2018213626A1 (fr) * 2017-05-17 2018-11-22 Avenu Medical, Inc. Système de découpe de tissu par électrode de cathéter unique destiné à créer des anastomoses

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