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WO2024191448A1 - Systèmes de repositionnement de vaisseaux sanguins - Google Patents

Systèmes de repositionnement de vaisseaux sanguins Download PDF

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Publication number
WO2024191448A1
WO2024191448A1 PCT/US2023/064146 US2023064146W WO2024191448A1 WO 2024191448 A1 WO2024191448 A1 WO 2024191448A1 US 2023064146 W US2023064146 W US 2023064146W WO 2024191448 A1 WO2024191448 A1 WO 2024191448A1
Authority
WO
WIPO (PCT)
Prior art keywords
hydrogel
blood vessel
fistula
target region
gel
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/US2023/064146
Other languages
English (en)
Inventor
Jordan ADDISON
Matthew R. CASIRARO
Cristian Esteban CLAVIJO
Hunter Thomas KEARNEY
Hoang Nguyen
Alexander Palmer
Mark Thomas
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 Peripheral Vascular Inc
Original Assignee
Bard Peripheral Vascular 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 Peripheral Vascular Inc filed Critical Bard Peripheral Vascular Inc
Priority to PCT/US2023/064146 priority Critical patent/WO2024191448A1/fr
Publication of WO2024191448A1 publication Critical patent/WO2024191448A1/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/02—Surgical instruments, devices or methods for holding wounds open, e.g. retractors; Tractors
    • A61B17/0218—Surgical instruments, devices or methods for holding wounds open, e.g. retractors; Tractors for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • 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
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3655—Arterio-venous shunts or fistulae
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00898—Material properties expandable upon contact with fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/02—Surgical instruments, devices or methods for holding wounds open, e.g. retractors; Tractors
    • A61B2017/0212—Cushions or pads, without holding arms, as tissue retainers, e.g. for retracting viscera
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A61B2017/1107—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis for blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A61B2017/1139—Side-to-side connections, e.g. shunt or X-connections
    • 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
    • A61B2018/00577—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
    • 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
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1422—Hook
    • 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
    • A61B2018/1475—Electrodes retractable in or deployable from a housing
    • 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
    • A61B2090/3966—Radiopaque markers visible in an X-ray image

Definitions

  • the present disclosure generally relates to systems and methods for repositioning blood vessels, and more specifically, to systems and methods for repositioning blood vessels utilizing hydrogel.
  • AVFs arteriovenous fistulas
  • anastomosis e.g., a channel
  • KDOQI Kidney Disease Outcomes Quality Initiative
  • a system for use in forming a fistula between blood vessels includes a gel introducing device configured to advance through the body and introduce a hydrogel to a target region adjacent to a first blood vessel to move the first blood vessel from an initial position to an adjusted position nearer to an adjacent second blood vessel.
  • the system further includes a fistula forming device configured to advance through the body and comprising a fistula forming element configured to form a fistula between the first and second blood vessels with the first blood vessel in the adjusted position.
  • the hydrogel introduced to the target region by the gel introducing device is configured to remain at the target region for a period of time to hold the first blood vessel in the adjusted position during the period of time.
  • a method of changing a position of a blood vessel in a body includes advancing a gel introducing device through the body toward a first blood vessel and introducing a hydrogel to a target region adjacent to the first blood vessel.
  • the hydrogel moves the first blood vessel from an initial position to an adjusted position nearer to an adjacent second blood vessel.
  • the method further includes leaving the hydrogel at the target region thereby holding the first blood vessel at the adjusted position for a period of time and forming a fistula between the first and second blood vessels with the first blood vessel in the adjusted position.
  • FIG. 1 A depicts a front view of a gel introducing device according to one or more aspects shown and described herein;
  • FIG. IB depicts an exploded view of the gel introducing device of FIG. 1A, according to one or more aspects shown and described herein;
  • FIG. 2 depicts a perspective view of a fistula forming device according to one or more aspects shown and described herein;
  • FIG. 3 A depicts an illustrative method of advancing the gel introducing device of FIG. 1 through a subject toward a first blood vessel, according to one or more aspects shown and described herein;
  • FIG. 3B depicts an illustrative method of introducing hydrogel to a target region, according to one or more aspects shown and described herein;
  • FIG. 3C depicts an illustrative method of moving the first blood vessel toward a second blood vessel, according to one or more aspects shown and described herein;
  • FIG. 3D depicts an illustrative method of holding the first blood vessel adjacent to the second blood vessel, according to one or more aspects shown and described herein;
  • FIG. 3E depicts an illustrative method of forming a fistula between the first and second blood vessels, according to one or more aspects shown and described herein;
  • FIG. 3F depicts an illustrative method of placing hydrogel around the fistula formed between the first and second blood vessels, according to one or more aspects shown and described herein.
  • the present disclosure is related to systems and methods of introducing hydrogel into a subject to move the position of blood vessels for forming a fistula between blood vessels.
  • the hydrogel pushes and/or supports a first blood vessel such that the first blood vessel is repositioned from an initial position in closer proximity to a second blood vessel.
  • the hydrogel can maintain its size and/or shape for a period of time to maintain the position of the first blood vessel.
  • a fistula can be formed between the blood vessels.
  • the first and second blood vessels may remain in this closer proximity configuration than the initial position until the fistula is healed.
  • the gel introducing device 100 includes a hydrogel applicator assembly 112 and an injection needle assembly 114.
  • the injection needle assembly 114 defines a longitudinal axis 116 of the gel introducing device 100.
  • the gel introducing device 100 is configured to facilitate delivery of a flowable hydrogel to a target region, wherein the hydrogel may be injected while the needle portion of injection needle assembly 114 is placed in a subject.
  • the injection needle assembly 114 is configured to puncture the subject’s tissue.
  • the injection needle assembly 114 may puncture the subject’s skin and tissue to be positioned adjacent to a blood vessel. It is noted that the injection needle assembly 114 may puncture the subject’s skin and tissue to be positioned adjacent target regions other than blood vessels depending on the desired procedure.
  • the gel introducing device 100 may be used in conjunction with an introducer cannula 118.
  • the introducer cannula 118 may facilitate withdrawal of the injection needle assembly 114 of the gel introducing device 100 from the subject.
  • the introducer cannula 118 may remain in place while the injection needle assembly 114 is withdrawn to maintain the access path in the subject to the target region, such as for example, to receive and guide a second device.
  • the hydrogel applicator assembly 112 includes a pair of syringes 120 and a manifold 121.
  • the hydrogel applicator assembly 112 is configured to separately carry a first component.
  • the first component and the second component are combined and mixed at the manifold 121.
  • the first component may include, for example, at least two N-hydroxy succinimide (NHS) ester groups,
  • the first component may be a solution containing polyethylene glycol (PEG) succinimidyl succinate.
  • the first component may be hydrogel.
  • the hydrogel applicator assembly 112 is configured to separately carry a second component.
  • the second component may be a solution containing albumin and/or polyethylenimine (PEI).
  • PEI polyethylenimine
  • the second component may include, for example, at least two amine groups.
  • the second component may be saline or other hydro-dissection solution, or the like.
  • the first component may include protein.
  • the first component may include albumin, PEI, and/or an amine containing PEG, or the like.
  • the second component may include precursor materials including, for example, but are not limited to, an A-hydroxysuccinimide (NHS) ester component such as PEG-(SS)2, PEG-(SS)4, PEG-(SS)8, PEG-(SG)4, PEG-(SG)8, and/or the like.
  • NMS A-hydroxysuccinimide
  • the hydrogel is a gel composed of one or more polymers.
  • the hydrogel are waterinsoluble, three-dimensional networks of polymer chains capable of holding large amounts of water.
  • the hydrogel may be a crosslinked hydrophilic polymer that does not dissolve in water, at least over a period of time, and that has many biomedical applications. Hydrogels may be absorbent yet maintain defined structures.
  • Hydrophilic polymer for example, includes polysaccharides (e.g., dextrin, alginate, chitosan, agarose, and pullulan), proteins (e.g., albumin, gelatin, collagen, lectin, legumine, and viciline), cellulose, polyethylene glycol ethers, polyamides, polyacrylic amides, polyurethanes with polyethylene glycol ether soft segments, ethoxylated graft polymers, etc.
  • polysaccharides e.g., dextrin, alginate, chitosan, agarose, and pullulan
  • proteins e.g., albumin, gelatin, collagen, lectin, legumine, and viciline
  • cellulose e.g., polyethylene glycol ethers, polyamides, polyacrylic amides, polyurethanes with polyethylene glycol ether soft segments, ethoxylated graft polymers, etc.
  • Gel time of the hydrogel could be manipulated between about 2-30 seconds.
  • two-part liquid-solution can be introduced in the subject and cure to a solid, putty -like material in about 2-30 seconds.
  • PEG-(SG)4 10,000 MW crosslinked with a 10- 30% rHA or HSA solution would have swelling, modulus, and degradation profile.
  • the gel time is considered as the time from which the solutions are freely flowing until they set up into a solid structure.
  • the gel time may be counted using a test method.
  • the test method may involve a stir bar rotating at 300 rpm within a container and introducing the two components into the container. Time is counted from when the components are mixed and to when the material becomes solid.
  • molecular weights of the PEG components may range from about 2,000 to about 100,000 g/mol.
  • hydrogel examples are not limited to currently available hydrogel and include hydrogel will become available in the future as long as the hydrogel has putty like characteristics (e.g., soft and malleable) so that to be utilized to move a blood vessel from an initial position to an adjusted position.
  • hydrogel may be seeded with cells prior to being placed into the subject. These cells may be fibroblasts, which are known to secrete collagen. Once the hydrogel degrades, its volume would be replaced by the collagen secreted by the fibroblasts thereby maintaining both vessels in proximity.
  • the hydrogel may include imaging agents that are imageable through respective imaging device to aid in confirming the placement of the hydrogel.
  • the hydrogel may be a radiopaque hydrogel that is imageable through x-ray imaging, so as to aid in confirming the placement of the hydrogel.
  • different mixtures or compositions of hydrogel may lead to different densities, cure time, and bioresorbable time of the cured hydrogel (e.g., solid hydrogel).
  • Hydrogel mixture can be optimized for allowing variability based on subject criteria or physician preference.
  • hydrogel mixture may be optimized such that the hydrogel remains in place for a period of time allowing blood vessels to endothelialize and fuse together after formation of a fistula.
  • the hydrogel may remain in place for at least about 30 days and/or for at most about 60 days.
  • the hydrogel may substantially dissolve and be absorbed into the subject.
  • the hydrogel substantially dissolves when at least about 90% of the hydrogel is dissolved.
  • the hydrogel is substantially dissolved when the hydrogel is degraded about 90% or more mass loss.
  • hydrogel may become a permanent composition spacer and does not degrade.
  • the pair of syringes 120 includes an actuator 128, a first component chamber 130, and a second component chamber 132.
  • First component chamber 130 may be, for example, a cylindrical tube that is configured to carry the first sealant component of the multi-component sealant.
  • First component chamber 130 has a first component port 130-1.
  • Second component chamber 132 also may be, for example, a cylindrical tube that is configured to carry the second sealant component of the multi-component sealant.
  • Second component chamber 132 has a second component port 132-1.
  • First component chamber 130 and second component chamber 132 are arranged in a longitudinally parallel arrangement.
  • the actuator 128 includes a first piston 134, a second piston 136, and a handle 138.
  • the handle 138 is in the form of a link member that perpendicularly extends between, and is connected to, each of the first piston 134 and the second piston 136 to facilitate simultaneous movement of the first piston 134 and the second piston 136 with the depression or retraction of the handle 138.
  • the first piston 134 is in the form of a plunger that is positioned in the first component chamber 130 proximal to the first component
  • the second piston 136 is in the form of a plunger that is positioned in the second component chamber 132 proximal to the second component.
  • the manifold 121 is removably connectable at a first coupling end 140-1 to the pair of syringes 120 by a pair of connectors 142-1, 142-2, and is removably connectable at a second coupling end 140-2 to the injection needle assembly 114 by a connector 144. More particularly, the manifold 121 includes a Y-connector 139 releasably connected to a coupling mechanism 122, wherein the coupling mechanism 122 serves as a detachable extension of the two-port portion of the Y-connector 139.
  • the Y-connector 139 (and more particularly the coupling mechanism 122) is removably connectable at the first coupling end 140-1 to the pair of syringes 120 by the pair of connectors 142-1, 142-2, and the Y-connector 39 is removably connectable at the second coupling end 140-2 to the injection needle assembly 114 by a connector 144.
  • the pair of connectors 142-1, 142-2 may form a threaded, or alternatively a snap-fit, connection with the pair of syringes 120.
  • the connector 144 may form a threaded, or alternatively a snap-fit, connection with the injection needle assembly 114.
  • the pair of connectors 142-1, 142-2 may be included as a part of the pair of syringes 120, and releasably connectable to the manifold 121.
  • the pair of connectors 142-1, 142-2 may be included as a part of the manifold 121, and releasably connectable to the pair of syringes 120.
  • the pair of connectors 142-1, 142-2 may be included as separate parts, each of which is separately connectable to each of the pair of syringes 120 and the manifold 121.
  • the manifold 121 has a first input port 122-1, a second input port 122-2, and at least one output port, which in the present embodiment is a single output port, referenced hereinafter as output port 222-3.
  • a coupling mechanism 122 of the manifold 121 has individual passages in fluid communication with the Y-connector 139.
  • the coupling mechanism 122 of the manifold 121 directly includes the first input port 122-1 and the second input port 122-2, and the Y-connector 139 of the manifold 121 directly includes the output port 122-3.
  • the at least one output port e.g., output port 122- 3
  • the at least one output port is in fluid communication with each of the first input port 122-1 and the second input port 122- 2.
  • the manifold 121 is connected to the pair of syringes 120, then the first input port 122-1 is in fluid communication with the first component chamber 130 and the second input port 122-2 is in fluid communication with the second component chamber 132.
  • the injection needle assembly 114 includes a hub 146 and an elongate hollow stylet 148 that extends distally from the hub 146.
  • the elongate hollow stylet 148 has a proximal portion 148-1 and a distal portion 148-2.
  • the hub 146 is fixedly attached, e.g., through overmolding, adhesive and/or press fit, to the proximal portion 148-1.
  • the hub 146 is configured for removable connection to the hydrogel applicator assembly 112. More particularly, the hub 146 of the injection needle assembly 114 may include a connector 151 that may form a threaded, or alternatively a snap-fit, connection with the connector 144 at the second coupling end 140-2 of the manifold 121.
  • the elongate hollow stylet 148 of the injection needle assembly 114 is configured to facilitate fluid communication with the at least one output port, e.g., the output port 122-3 of the manifold 121 so as to receive the hydrogel from the hydrogel applicator assembly 112.
  • the distal portion 148-2 may have a closed distal end 150 and a plurality of side ports 152 (e.g., at least three) proximal to the closed distal end 150.
  • the closed distal end 150 may be, for example, a needle tip 154.
  • the elongate hollow stylet 148 may be constructed, for example, by an elongate cannula 156 being fixedly connected to the needle tip 154, with the plurality of side ports 152 being located in the elongate cannula 156 immediately proximal to the needle tip 154. More particularly, the elongate cannula 156 defines a side wall 148-3 that surrounds a lumen of the elongate hollow stylet 148, wherein the plurality of side ports 152 radially extend from the lumen and through the side wall 148-3 of the elongate hollow stylet 148 in the distal portion 148-2.
  • the needle tip 154 is defined, at least in part, by the closed distal end 150 of the elongate hollow stylet 148, wherein the needle tip 154 is attached, e.g., welded, press fit, or with adhesive, to the elongate cannula 156 to distally close the lumen. Stated differently, the needle tip 154 terminates a distal extent of the lumen.
  • the plurality of side ports 152 are in fluid communication with the at least one output port, e.g., the output port 122-3 by way of the lumen the elongate hollow stylet 148.
  • the needle tip 154 may be opened and the hydrogel may flow through the lumen and flow out via the needle tip 154.
  • the plurality of side ports 152 are located in the distal portion 148-2 and arranged, e.g., in a ring pattern, around a perimeter of the elongate hollow stylet 148, such as in 120 degree increments, for example, when there are three side ports 152.
  • the flowable hydrogel may be delivered 360 degrees around the elongate hollow stylet 148.
  • the plurality of side ports 152 may be configured as two, or two pairs, of diametrically opposed side ports.
  • the injection needle assembly 114 may be used in conjunction with the introducer cannula 118 (also sometimes referred to in the art as a coaxial introducer needle) to allow the elongate hollow stylet 148 to be removed from introducer cannula 118, while maintaining access to the target region with the introducer cannula 118.
  • the gel introducing device 100 may be removed from the introducer cannula 118 and replaced with a variety of other instruments, such as another stylet or a biopsy device.
  • the introducer cannula 118 has a coaxial hub 118-1, a coaxial cannula 118-2, a cannula lumen 118-3 and a distal annular rim 118-4.
  • the cannula lumen 118-3 e.g., is configured, e.g., having a cylindrical shape, to receive elongate hollow stylet 148 of injection needle assembly 114.
  • the elongate hollow stylet 148 of injection needle assembly 114 When the elongate hollow stylet 148 of injection needle assembly 114 is fully inserted into cannula lumen 118-3 (e.g., distal movement of the elongate hollow stylet 148 is stopped by contact of hub 146 with the coaxial hub 118-1, the plurality of side ports 152 of the elongate hollow stylet 148 are located distal to the distal annular rim 118-4 of the introducer cannula 118.
  • a spacer body (e.g., a spacer body 56 filled with hydrogel 54 in FIG. 3F) may be introduced into a subject and be filled with hydrogel injected by the gel introducing device 100.
  • the spacer body may be biodegradable, resorbable, or dissolvable.
  • the spacer body encapsulates the hydrogel.
  • the spacer body may be formed similar to a bag or a balloon that may expand when hydrogel is introduced in an interior space of the spacer. Similar to hydrogel injection, the spacer body may be utilized to move blood vessels in appropriate proximity for an endovascular AVF creation procedure.
  • the spacer body may be used individually or with the hydrogel injection into the spacer body or in proximity with the spacer body.
  • the system further includes a fistula forming device 200 that may include a first catheter 210 and a second catheter 220.
  • the first catheter 210 may include a first catheter body 211 and a fistula forming element 214 (e.g., an element capable of cutting through tissue, such as an electrode or a blade, which may extend from the first catheter body 211), which may be advanced out of a fistula forming element housing 212.
  • Current may be passed through the fistula forming element 214 to ablate or otherwise remove tissue contacted by the fistula forming element 214.
  • the size and/or shape of the fistula forming element 214 may at least in part determine the size (e.g., length, width) and/or shape of the fistula formed by the ablation.
  • the size and/or shape of the fistula forming element 214 may be selected to result in a fistula with a particular configuration, which may in turn be based on the desired effect on blood pressure.
  • the fistula forming element housing 212 (e.g., a ceramic housing or the like) within the first catheter body 211 may help protect other components of the first catheter 210 from heat that may be generated by the fistula forming element 214 during ablation or tissue removal.
  • the first catheter 210 may further have a first tip 216 tapered toward a distal end of the first catheter 210 to help advancement of the first catheter 210 through a blood vessel.
  • the second catheter 220 may include a second catheter body 221 and a recess 222 for receiving the fistula forming element 214 of the first catheter 210 as the fistula forming element 214 cuts through tissue and extends away from the first catheter 210.
  • a backstop may be provided in place of recess 222 to compress against tissue to reduce a thickness of tissue for cutting by the fistula forming element 214.
  • the second catheter 220 may include an electrode for forming a fistula.
  • the second catheter 220 may further have a second tip 226 tapered toward a distal end of the second catheter 220 to help advancement of the second catheter 220 through a blood vessel.
  • the first catheter 210 may be advanced through a first blood vessel and the second catheter 220 may be advanced through a second blood vessel.
  • the fistula forming element 214 of the first catheter 210 may be axially positioned relative to the recess 222 of the second catheter 220.
  • the fistula forming element 214 and the recess 222 may be axially aligned with a desired fistula formation site.
  • the fistula forming element 214 may be energized to ablate the first blood vessel and the second blood vessel at the desired fistula formation site. As a result, a fistula is formed between the first blood vessel and the second blood vessel.
  • the first catheter body 211 and the second catheter body 221 may be flexible to be advanced through one or more turns, bends, curves, and/or paths in a subject (e.g., blood vessels, organs, space between bones, organs, or blood vessels, or the like).
  • the first catheter body 211 and the second catheter body 221 may include magnets have magnetic poles that attract the first catheter 210 and the second catheter 220 when aligned. For example, when the fistula forming element housing 212 and the recess 222 are axially aligned and face each other, the first catheter 210 and the second catheter 220 attract each other to sandwich blood vessel walls therebetween to form a fistula.
  • an illustrative method of advancing the gel introducing device 100 through a subject toward a first blood vessel 30 The needle tip 154 of the injection needle assembly 114 may be advanced to a target region 60 adjacent to the first blood vessel 30 for introducing hydrogel.
  • the needle tip 154 may be positioned at a side of the first blood vessel 30 opposite to an opposite side of the first blood vessel 30 that faces toward the second blood vessel 40.
  • the needle tip 154 may be positioned to a side of the first blood vessel 30 facing away from the second blood vessel 40.
  • the first blood vessel 30 is repositioned from an initial position 30a to an adjusted position 30b (shown in FIG. 3D) nearer to the second blood vessel 40 adjacent to the first blood vessel 30.
  • hydrogel 50 is injected to the target region 60.
  • the hydrogel is flowable when injected into the subject and is cured over time.
  • imaging agents in hydrogel may allow a practitioner to confirm the position of the hydrogel via an imaging device.
  • the needle tip 154 may be visualized via an imaging device that may allow a practitioner to confirm the position of the side ports 152 and the needle tip 154 for precise inj ection of the hydrogel 50 to the target region 60.
  • the hydrogel 50 is further injected to the target region 60 until a desirable distance between the first blood vessel 30 and the second blood vessel 40 is reached.
  • the injection procedure may be repeated until the desirable distance is achieved.
  • the needle tip 154 may be repositioned to adjust the shape of the first blood vessel 30.
  • the side ports 152 may be repositioned to inject hydrogel at a different location near the target region 60 to form a gentle curve of increased radius of curvature with the first blood vessel 30.
  • the hydrogel 50 may be injected until reaching a certain size or amount (e.g., a size enough to move the first blood vessel 30 in close proximity with the second blood vessel 40).
  • the gentle curve may provide increased support for the first blood vessel 30 to maintain close proximity between the first blood vessel 30 and the second blood vessel 40 and/or better accessibility for the fistula forming device 200 for forming a fistula without overly bending the blood vessel 30 to an undesired amount.
  • the first blood vessel 30 is supported by the hydrogel 50 in the adjusted position.
  • the hydrogel 50 may be supported to be maintained in the adjusted position during a period of time. ‘Maintain’ the position may be defined as two vessels having a substantially fixed distance between them (e.g., less than 1 mm) maintaining a close proximity over time.
  • the first blood vessel 30 and the second blood vessel 40 are in close proximity when the distance between the first blood vessel 30 and the second blood vessel 40 is below a predetermined distance and allows forming a fistula between them.
  • the first blood vessel 30 and the second blood vessel 40 are in close proximity when the closest distance between them is about 1 mm or less.
  • an AVF can be created endovascularly with a fistula forming device.
  • the fistula forming device includes two catheters attracting each other with magnetic force (e.g., some embodiments of the fistula forming device 200).
  • the fistula forming device 200 is advanced through the subject. Specifically, the first catheter 210 is advanced through the first blood vessel 30 and the second catheter 220 is advanced through the second blood vessel 40. In embodiments, the first catheter 210 and the second catheter 220 may be switched. For example, the first catheter 210 is advanced through the second blood vessel 40 and the second catheter 220 is advanced through the first blood vessel 30.
  • the first catheter 210 and the second catheter 220 are aligned and the fistula forming element 214 is extended out from the fistula forming element housing 212 in FIG. 3E.
  • the fistula forming element 214 pierces blood vessel walls of the first blood vessel 30 and the second blood vessel 40.
  • the fistula forming element 214 may be energized to form a fistula 90 between the first blood vessel 30 and the second blood vessel 40.
  • the fistula forming element 214 may be retracted in the fistula forming element housing 212 after forming the fistula 90.
  • the first catheter 210 and the second catheter 220 then be withdrawn from the subject.
  • the hydrogel 50 may remain at the target region 60 for a period of time (e.g., between 30 to 60 days) to hold and/or support the first blood vessel 30 at the adjusted position 30b near the second blood vessel 40.
  • a period of time e.g., between 30 to 60 days
  • the fistula 90 may be healed to function properly without the first blood vessel 30 being pulled away from the second blood vessel 40 (e.g., the first blood vessel 30 is moved back to the initial position).
  • the hydrogel may dissolve and be absorbed into the subject.
  • additional hydrogel 52 or 54 may be introduced into the subject by the gel introducing device 100.
  • the additional hydrogel 52 or 54 may be introduced before or after the fistula forming device 200 is withdrawn.
  • the additional hydrogel 52 or 54 may be introduced before or after formation of the fistula 90.
  • the hydrogel 54 may be introduced into the spacer body 56 such that the spacer body 56 encapsulates the hydrogel 54.
  • the hydrogel 52 is placed a space around the fistula 90 formed between the first blood vessel 30 and the second blood vessel 40.
  • the hydrogel 52 may cover an outer surface of the first blood vessel 30 and the second blood vessel 40 around the fistula 90.
  • the hydrogel 52 may help heal the fistula 90.
  • a system for use in forming a fistula between blood vessels comprising: a gel introducing device configured to advance through the body and introduce a hydrogel to a target region adjacent to a first blood vessel to reposition the first blood vessel from an initial position to an adjusted position nearer to an adjacent second blood vessel than the initial position; and a fistula forming device configured to advance through the body and comprising a fistula forming element configured to form a fistula between the first and second blood vessels with the first blood vessel in the adjusted position; wherein the hydrogel introduced to the target region by the gel introducing device is configured to remain at the target region for a period of time to maintain the first blood vessel in the adjusted position during the period of time. [0060] 2. The system of clause 1, wherein the hydrogel is configured to dissolve in the body after the period of time.
  • hydrogel comprises a cross linked hydrophilic polymer.
  • a method of changing a position of a blood vessel in a body comprising: advancing a gel introducing device through the body toward a first blood vessel; introducing a hydrogel to a target region adjacent to the first blood vessel, the hydrogel moving the first blood vessel from an initial position to an adjusted position nearer to an adjacent second blood vessel; leaving the hydrogel at the target region thereby holding the first blood vessel at the adjusted position for a period of time; and forming a fistula between the first and second blood vessels with the first blood vessel in the adjusted position.
  • the hydrogel is configured to dissolve in the body after the period of time.
  • hydrogel comprises a cross linked hydrophilic polymer.

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Abstract

L'invention concerne un système destiné à être utilisé dans la formation d'une fistule entre des vaisseaux sanguins. Le système comprend un dispositif d'introduction de gel configuré pour avancer à travers le corps et introduire un hydrogel dans une région cible adjacente à un premier vaisseau sanguin pour déplacer le premier vaisseau sanguin d'une position initiale à une position ajustée plus proche d'un second vaisseau sanguin adjacent que la position initiale. Un dispositif de formation de fistule est configuré pour avancer à travers le corps et comprenant un élément de formation de fistule configuré pour former une fistule entre les premier et second vaisseaux sanguins avec le premier vaisseau sanguin dans la position ajustée. L'hydrogel introduit dans la région cible par le dispositif d'introduction de gel est configuré pour rester au niveau de la région cible pendant une période de temps pour maintenir le premier vaisseau sanguin dans la position ajustée pendant la période de temps.
PCT/US2023/064146 2023-03-10 2023-03-10 Systèmes de repositionnement de vaisseaux sanguins Pending WO2024191448A1 (fr)

Priority Applications (1)

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PCT/US2023/064146 WO2024191448A1 (fr) 2023-03-10 2023-03-10 Systèmes de repositionnement de vaisseaux sanguins

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2023/064146 WO2024191448A1 (fr) 2023-03-10 2023-03-10 Systèmes de repositionnement de vaisseaux sanguins

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WO2024191448A1 true WO2024191448A1 (fr) 2024-09-19

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030163144A1 (en) * 2002-02-28 2003-08-28 Weadock Kevin S. Sponge for creating an anastomosis between vessels
US20030229363A1 (en) * 2002-06-05 2003-12-11 Sharkawy A. Adam Methods and devices for facilitating the formation of connections between tissue structures
US20060116699A1 (en) * 1999-07-28 2006-06-01 Cardica, Inc. Adhesive-based anastomosis method and system
US20220249094A1 (en) * 2019-11-01 2022-08-11 Limflow Gmbh Devices and methods for increasing blood perfusion to a distal extremity

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060116699A1 (en) * 1999-07-28 2006-06-01 Cardica, Inc. Adhesive-based anastomosis method and system
US20030163144A1 (en) * 2002-02-28 2003-08-28 Weadock Kevin S. Sponge for creating an anastomosis between vessels
US20030229363A1 (en) * 2002-06-05 2003-12-11 Sharkawy A. Adam Methods and devices for facilitating the formation of connections between tissue structures
US20220249094A1 (en) * 2019-11-01 2022-08-11 Limflow Gmbh Devices and methods for increasing blood perfusion to a distal extremity

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