WO2025064653A2 - Dispositif, système et procédé d'accès, pour anastomose côté extrémité, à une vascularisation périphérique - Google Patents

Dispositif, système et procédé d'accès, pour anastomose côté extrémité, à une vascularisation périphérique Download PDF

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Publication number
WO2025064653A2
WO2025064653A2 PCT/US2024/047455 US2024047455W WO2025064653A2 WO 2025064653 A2 WO2025064653 A2 WO 2025064653A2 US 2024047455 W US2024047455 W US 2024047455W WO 2025064653 A2 WO2025064653 A2 WO 2025064653A2
Authority
WO
WIPO (PCT)
Prior art keywords
access
graft
blood vessel
flange
sutureless
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/US2024/047455
Other languages
English (en)
Other versions
WO2025064653A3 (fr
Inventor
Max Bannister Mitchell
Jeremy H. Morgan
Jeffrey Steinmetz
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.)
University of Colorado System
University of Colorado Colorado Springs
Connex Biomedical Inc
Original Assignee
University of Colorado System
University of Colorado Colorado Springs
Connex Biomedical 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 University of Colorado System, University of Colorado Colorado Springs, Connex Biomedical Inc filed Critical University of Colorado System
Publication of WO2025064653A2 publication Critical patent/WO2025064653A2/fr
Publication of WO2025064653A3 publication Critical patent/WO2025064653A3/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
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/064—Blood vessels with special features to facilitate anastomotic coupling
    • 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
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B2017/0641—Surgical staples, i.e. penetrating the tissue having at least three legs as part of one single body
    • 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
    • A61B2017/1135—End-to-side connections, e.g. T- or Y-connections

Definitions

  • the present disclosure pertains to access devices and systems for placement of medical devices into and through the peripheral vasculature. More particularly, the present disclosure pertains to access devices and systems for introduction, placement, and withdrawal of circulatory assist devices into and through the peripheral vasculature, arterial cannulation for cardiopulmonary bypass, extra corporeal membrane oxygenation (ECMO), and/or bypass grafting.
  • ECMO extra corporeal membrane oxygenation
  • the present disclosure pertains to access devices and systems for introduction and placement of circulatory assist devices, such as a catheter-based axial flow ventricular assist device (AF-VAD) into and through the axillary, innominate, iliac, or common femoral arteries and into a chamber of the heart, followed by withdrawal of the AF-VAD from the heart and axillary artery and closure of the arterial access site.
  • circulatory assist devices such as a catheter-based axial flow ventricular assist device (AF-VAD) into and through the axillary, innominate, iliac, or common femoral arteries and into a chamber of the heart, followed by withdrawal of the AF-VAD from the heart and axillary artery and closure of the arterial access site.
  • AF-VAD catheter-based axial flow ventricular assist device
  • Access to the peripheral vasculature such as, for example, the axillary artery, requires either percutaneous or surgical access to the blood vessel. Where percutaneous access is performed, access may be
  • a tubular access graft that is configured to couple to an anastomosis site and is secured at the anastomosis site at least one reinforced flange at a distal end of the access graft wherein reinforcement in the flange expands the flange and abuts a luminal wall surface of a blood vessel and/or by having an anastomosis connector.
  • a sealing access port that couples to an anastomosis site, wherein the port has a central opening with a seal that allows a medical device, such as an AF-VAD to pass into and through the central opening, reside within 6551-016.PCT_IntApp.docx 1 Attorney Docket No.: 6551-016.PCT Customer No.29,335 the opening in a hemostatic manner, and allows for withdrawal of the medical device through the central opening and sealing the anastomosis site post-procedure.
  • the first variant of the access device and system of the present disclosure has several sub-variants.
  • a first sub-variant includes a reinforced flanged graft in which there is at least one distal flange that is angularly displaced from the longitudinal axis of the tubular graft, such as having about a 30-degree to about a 40-degree angle, and a support ring.
  • the flange is reinforced with any of a wide variety of reinforcements, including, for example, a latticed stent-like structure that is either coupled to or encapsulated within the flange, at least one wire that is either coupled to or encapsulated within the flange, a wire hoop coupled to at least a portion of the outer perimeter of the flange with the wire hoop being either an elastic or shape memory material that is configured to fold upon itself and then deploy into either a circumferential reinforcement of the flange or as figure-8 or lemniscate configuration in which the wire overlaps itself intermediate opposing open loop the figure-8 or lemniscate structure, when delivered into the arteriotomy to expand the flange and seat the flange within the blood vessel.
  • a latticed stent-like structure that is either coupled to or encapsulated within the flange
  • at least one wire that is either coupled to or encapsulated within the flange
  • a wire hoop coupled to at least a portion of the outer
  • the at least one distal flange is adapted to nest, at least partially, against the luminal wall of the blood vessel, for example by assuming a generally saddle-shape under the influence of the reinforcing member and upon being released within the blood vessel.
  • an optional axial compression ring or cuff may be provided that is placed over the access graft and placed against the abluminal wall of the blood vessel.
  • the axial compression ring or cuff seats exerts an axial pressure against the abluminal wall of the blood vessel and axially tensions the distal flange against the luminal wall of the blood vessel, thereby sealing the arteriotomy between the distal flange and the axial compression ring or cuff.
  • the reinforcement member of the distal flange may be coupled to a peripheral surface of the distal flange, may be coupled to the radial surface(s) of the distal flange, or may be embedded or encapsulated in the material of the distal flange.
  • the at least one distal flange may consist of two 6551-016.PCT_IntApp.docx 2 Attorney Docket No.: 6551-016.PCT Customer No.29,335 diametrically extending and opposing flanges, with a first flange extending in a proximal orientation and a second flange extending in a distal orientation relative to a longitudinal axis of the blood vessel.
  • the first and second flanges may be symmetrical or asymmetrical with each other. Where two diametrically extending and opposing flanges are asymmetrical, the two flanges will have different configurations with the first flange having a different configuration than the second flange.
  • the second flange will have a smaller profile that the first flange and project distally relative to blood flow through the blood vessel and cover a smaller luminal surface area of the blood vessel, such as less than a 180-degree arc about the circumference of the blood vessel, than the first flange.
  • the first flange may extend proximally along a length of the blood vessel and extend about a substantial or entire circumferential aspect of the blood vessel with the reinforcing member and the first flange forming a tubular section of the first flange.
  • the angular displacement be oriented such that the access graft enters the blood vessel with an orientation dictated by the device being passed through the access graft.
  • the angular orientation of the access graft will be such that it facilitates passage of the AF- VAD into the axillary artery proximally relative to the blood flow to direct passage of the AF- VAD upstream in the blood flow toward the aorta.
  • the axial compression ring or cuff may have a wide variety of configurations, including, for example a shape memory wire that is formed into a semi-circular, semi-ovular, or semi- elliptical shape and a shape memory tube that receives opposing ends of the shape memory wire within the lumen of the shape memory tube to allow the diametric expansion and contraction of the shape memory wire.
  • the axial compression ring or cuff may be an elastic collar, band, or annular ring that is concentrically engageable about the access graft.
  • the access graft may have helical projections on an exterior surface thereof that engage the structures on the axial compression ring or cuff to allow the axial compression ring or cuff to rotate about the access graft until abutting the abluminal surface of the blood vessel.
  • the access graft may have circumferential rings or detents that engage with mating structures on the axial compression ring or cuff and allow for translation of the axial compression ring or cuff along a length of the access graft until the axial compression ring or cuff is abutting the abluminal surface of the blood vessel.
  • the first flange forms a toe portion and the second flange forms a heel portion of the distal flange.
  • a medical device such as an AF-VAD, may be introduced through the access graft, pass into the blood vessel, e.g., the axillary artery, and be delivered upstream in the blood flow to the heart where it will perform its function as a circulatory assist device for a period of time.
  • the AF-VAD is removed in a retrograde manner through the blood vessels and out the access graft. After removal from the access graft, the access graft is either closed or removed surgically with closure of the arteriotomy.
  • first flange with a structural support that reinforces the first flange and supports the first flange in an abutting relationship with the luminal wall surface of the blood vessel about a circumferential arc greater than 180-degrees about the circumference of the luminal wall surface of the blood vessel.
  • second flange with a structural support that reinforces the second flange and supports the second flange in an abutting relationship with the luminal wall surface of the blood vessel about a circumferential arc less than 180-degrees about the circumference of the luminal wall surface of the blood vessel.
  • distal flange with a structural support that is joined to proximal and distal portions of the distal flange but not the lateral portions of the distal flange.
  • wire structural support joined to the proximal and distal portions of the distal flange and not the lateral portions of the distal flange, wherein the wire is configured to expand into a figure-8 or lemniscate configuration about the entire circumferential aspect of the luminal wall surface of the blood vessel and support the distal flange against the luminal wall surface of the blood vessel.
  • Fig.1 is a diagrammatic illustration of an access graft joined in an angled end-to-side anastomosis to a peripheral blood vessel in accordance with the access device and assembly of the present disclosure.
  • Fig.2 is a diagrammatic illustration showing an angled end-to-side anastomosis of an access graft, distal flange, and reinforcement member of the access device and assembly according to the present disclosure.
  • Fig.3 is a diagrammatic view of a variant of an angled end-to-side anastomosis of an access graft, distal flange, reinforcement member, and axial compression ring or cuff of the access device and assembly according to the present disclosure.
  • Fig.8 is a diagrammatic view of an angled end-to-side anastomosis depicting a variant of the access graft and an asymmetric reinforced distal flange and reinforcing member in accordance with the access device and assembly of the present disclosure.
  • Fig.9a is a diagrammatic illustration of another variant of the access device and assembly according to the present disclosure illustrating a two-piece variant of the access device.
  • Fig.9b is a diagrammatic illustration of the two-piece variant of the access device in its assembled state.
  • Figs 13a to 13c are sequential diagrammatic views of an everting end-side anastomosis access and closure ring in accordance with a variant of the access device and assembly of the present disclosure.
  • Figs.14a to 14d are sequential diagrammatic views of the everting end-side anastomosis access and closure ring coupled to vascular tissue and showing the sequential steps of vascular access site eversion and coupling to the access and closure ring.
  • first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer, or section.
  • substantially vertical may be less than, greater than, or equal to completely vertical.
  • “About” is intended to mean a quantity, property, or value that is present at ⁇ 10%. Throughout this disclosure, the numerical values represent approximate measures or limits to ranges to encompass minor deviations from the given values and embodiments having about the value mentioned as well as those having exactly the value mentioned. Other than in the working examples provided at the end of the detailed description, all numerical values of parameters (e.g., of quantities or conditions) in this specification, including the appended claims, are to be understood as being modified in all instances by the term “about” whether or not “about” actually appears before the numerical value.
  • proximal or distal are intended to be relative positional references and are used with reference either to a direction of blood flow relative to a device or device component or with reference to a longitudinal axis of a device or device component.
  • the proximal end of the graft component furthest away from the major vessel or anatomic passageway, whereas the distal end of the graft is the end closest to the major vessel or anatomic passageway.
  • the term “saddle-shape” when used in connection with an element is intended to mean a generally hyperbolic paraboloid structure.
  • the term “graft” is intended to refer to any type of polymeric, biological, composite or metal tubular structure.
  • anatomic passageway is intended to refer to any anatomical structure having a lumen.
  • anatomic passageways are blood vessels, the gastrointestinal track, 6551-016.PCT_IntApp.docx 10 Attorney Docket No.: 6551-016.PCT Customer No.29,335 including the esophagus, stomach, small intestine, large intestine, and rectum, or airway passages, such as the trachea and bronchi.
  • the terms “peripheral blood vessel” is used herein to reference the blood vessels outside the heart. It is intended that the term includes arteries, such as, for example, as the axillary, innominate, iliac, and/or femoral arteries, as well as their corresponding veins.
  • flange is intended to refer to any type of radially extending projection, including, without limitation, a projection that extends less than or equal to 360 degrees relative to the element that the projection extends from. Further, a flange may have a longitudinal component to its projection orientation relative to the element that the projection extends from.
  • Access device 10 is configured to couple to a blood vessel 2, particularly a peripheral blood vessel, such as an axillary artery.
  • Access device 10 consists generally of an access graft 12 having at least one distal flange 14 that projects radially outward from a central longitudinal axis of the access graft 12.
  • a reinforcing member 16 is provided in association with the at least one distal flange 14 and is adapted to diametrically expand the at least one distal flange 14 after the at least one distal flange 14 is positioned within a lumen of the blood vessel 2 and allow the at least one flange 14 to nest against and abut a luminal wall surface of the blood vessel 2.
  • Access graft 12 is configured such that the at least one distal flange 14 is positioned at a distal end of the access graft 12 and is angularly displaced from a longitudinal axis of the access 6551-016.PCT_IntApp.docx 11 Attorney Docket No.: 6551-016.PCT Customer No.29,335 graft 12.
  • the angular displacement of the at least one distal flange 14 forms a non-circular distal end opening 13 of the access graft 12 where it joins the blood vessel 2, as illustrated in Fig.10.
  • Reinforcing member 16 may have a wide variety of configurations. As shown in Figure 2, the reinforcing member 16 is associated with the at least one distal flange 14 by embedding, encapsulating, joining, or otherwise attaching the reinforcing member 16 to the at least one distal flange 14.
  • the reinforcing member 16 may be coupled to a peripheral surface or edge of the at least one distal flange14, may be coupled to a radial surface or surfaces of the at least one distal 6551-016.PCT_IntApp.docx 12 Attorney Docket No.: 6551-016.PCT Customer No.29,335 flange 14, or may be embedded or encapsulated in the material of the at least one distal flange 14.
  • the reinforcement member 16 may be coupled to the at least one distal flange 14 in discrete portions of the at least one distal flange 14, about an entire periphery of the at least one distal flange 14, or about an entire circumferential portion of the at least one distal flange 14. It is important that the reinforcement member 16 be coupled to the at least one distal flange 14 in such a manner as it facilitates diametric expansion of the at least one distal flange 14 in a manner that permits the at least one distal flange 14 to seat against the luminal wall surface of the blood vessel 2, positionally secures the access graft 12, and allows for the blood vessel 2 to remain patent.
  • the reinforcing member 16 is a circumferential wire coupled to a peripheral surface of the at least one distal flange 14.
  • the circumferential wire reinforcing member 16 is configured to diametrically expand and urge the at least one distal flange 14 into a configuration that abuts the luminal wall surface of the blood vessel 2.
  • the reinforcing member 26 of access device and assembly 20 consists of a wire that is configured into a figure 8 or lemniscate configuration and coupled only to a proximal portion 23 and a distal portion 27 of the at least one distal flange 24, leaving the lateral portions of the at least one flange not coupled to the reinforcing member 26.
  • the proximal portion 23 and distal portion 27 of the at least one flange are oriented parallel to the longitudinal axis of the blood vessel.
  • the uncoupled portion of the reinforcing member forms an overlapping portion 28 of the reinforcing member 26 and circumscribes a circumferential aspect of the luminal wall of the blood vessel, forming a proximal loop 21 and a distal loop 29 that are open to blood flow F there through.
  • This figure 8 or lemniscate configuration of the reinforcing member 26 also helps to abut the at least one distal flange 24 against the luminal wall surface of the blood vessel 2 at the access site 8.
  • a variant of the access device and assembly 20 is access device 30 illustrated in Fig.5.
  • Access device 30 is identical to access device 20, in that it has an access graft 32, at least one distal flange 34 at a distal end of the access graft, where the at least one distal flange 34 is angularly displaced from the longitudinal axis of the access graft 32.
  • the reinforcing member 36 is a looped wire that expands to deploy the at least one distal flange 34 within the blood vessel 2 and is coupled to the at least one distal flange 34 at proximal and distal portions of the reinforcing member only.
  • the reinforcing member 36 when deployed within the access site 8 and the lumen of the blood vessel 2, assumes a figure 8 or lemniscate configuration in which there is an overlap 38, a proximal loop 31 and a distal loop 39, again relative to the direction of blood flow F through the blood vessel.
  • the 6551-016.PCT_IntApp.docx 14 Attorney Docket No.: 6551-016.PCT Customer No.29,335 difference between access device 20 and access device 30 is that in access device 30, no axial compression ring or cuff is employed and the expansive force of the reinforcing member 36 is sufficient to maintain hemostasis with the at least one flange being pressed against the luminal wall surface of the blood vessel at the access site 8.
  • Access device 40 consists of an access graft 42 having at least one distal flange 44, and at least one reinforcing member 46.
  • the access graft 42 is angularly displaced from the at least one distal flange 44 to form a non-circular distal end opening of the access graft 42 at the at least one distal flange 44.
  • the reinforcing member 46 consists of two or more arcuate reinforcing members 46 coupled to the at least one distal flange 44 and positioned at proximal 43 and distal 49 portions, respectively, of the at least one distal flange 44.
  • the two or more arcuate reinforcing members 46 are coupled in such a manner as to reinforce the proximal 43 and distal 49 portions of the at least one distal flange 44 such that the at least one distal flange 44 is configured to abut against the luminal wall of the blood vessel 2 around the access site 8.
  • the axial compression ring or cuff 50 consists of an elongate wire member 52 having opposing ends (not shown) and a tubular member 54 having open ends 54a and 54b that each receive one of the opposing ends of the elongate wire member 52 therein.
  • the elongate wire member 52 assumes a generally circular or ovular shape while the elongate wire member 52 is constrained by the tubular member 54.
  • the opposing ends of the elongate wire member 52 are free to move within the tubular member 54 to allow for diametric expansion and contraction of the elongate wire member
  • the elongate wire member 42 is, therefore, and/or the tubular member 54.
  • Fig.8 illustrates another variant of the access device 60.
  • access device 60 is characterized by having a distal flange 64 having a generally T-shape in which there is proximal projecting flange 63 and a distal projecting flange 67.
  • the proximal projecting flange 63 and the distal projecting flange 67 are asymmetric relative to one another.
  • Reinforcing member 66 supports the distal flange 64, including the proximal projecting flange 63 and the distal projecting flange 67.
  • the proximal projecting flange 63 forms a toe portion of the access device 60 and extends about at least a substantial circumferential extent of the blood vessel 2 lumen and forms a blood flow pathway 69 through the proximal projecting flange 63.
  • a proximal section 66a portion of the reinforcing member 66 supports the proximal projecting flange 63 and applies an expansive force to abut the distal flange 64 against the luminal wall surface of the blood vessel 2.
  • the distal projecting flange 67 forms a heel portion of the access device 60 and is supported by a distal section 66b of the reinforcing member 66.
  • the distal section 66b applies an expansive force to abut the distal projecting flange 67 against the luminal wall surface of the blood vessel and proximate to the access site 8.
  • the proximal projecting flange 63 is configured to extend proximally, or upstream relative to blood flow F, within the blood vessel 2, extends about at least a substantial circumferential extent of the lumen of the blood vessel 2, and forms a blood flow pathway 69 through the proximal projecting flange 63.
  • the distal projecting flange 67 extends about less than a 180-degree arc about the circumference of the lumen of the blood vessel and project distally relative to the blood flow F and the access site 8.
  • the reinforcing member 66 may, optionally, have a proximal section that is concentric with a portion of the access graft 62 that projects outward from the access site in the blood vessel 2. In this configuration, the reinforcing member 66 also supports the angular displacement of the access graft 62 relative to the distal flange 64. In this manner, introduction of a catheter-based medical device into and through the access graft 62 is oriented to guide the medical device toward and into the proximal projecting flange 63 to guide the medical device into the proximal portion of the blood vessel 2. [0076] A two-piece variant 70 of the access device and assembly of the present disclosure is illustrated in Figs.9a-9c.
  • the two-piece variant 70 includes a covered stent-like reinforcing member 76 that is similar to reinforcing member 66 in that it is a lattice structure having a 6551-016.PCT_IntApp.docx 16 Attorney Docket No.: 6551-016.PCT Customer No.29,335 covering that is configured into a generally T-shaped configuration having a proximal projecting flange 73, a distal projecting flange 77, and a tubular projection 71 that is configured to project out from the access site 8 in the blood vessel when coupled in and end-to-side anastomosis with the blood vessel 2, as depicted in Fig.9c.
  • the proximal projecting flange 73 forms a toe portion of the access device 70 and the distal projecting flange 77 forms a heel portion of the access device 70, with both the toe portion and the heel portion being disposed within the access site 8 when the end-to-side anastomosis is formed.
  • the tubular projection 71 that joins with access graft 72, projects laterally outward from the access site 8 in the blood vessel 2.
  • the proximal projecting flange 78 preferably extends about at least a substantial circumferential extent of the blood vessel 2 lumen and forms a blood flow pathway through the proximal projecting flange 73.
  • the access graft 72 may be joined to the tubular projection 71 prior to forming the end-to-side anastomosis with the access device and assembly 70.
  • the reinforcing member may be delivered into and through the access site 8 and expanded to seat against the blood vessel 2 lumen with the tubular projection 71 projecting laterally outward from the access site 8, then the access graft 72 is delivered and coupled to the tubular projection 71.
  • FIG. 10 A further variant 80 of the access device and assembly of the present disclosure is shown in Fig.10.
  • access graft 82 has at least one distal flange 84 that is reinforced by a reinforcing member 86, an engagement member 87 proximal to the at least one distal flange 84 on the access graft 82, and an axial compression cuff 85.
  • Engagement member 87 may be any of a wide variety of engagements configured to cooperate with a mating engagement on the axial compression cuff 85.
  • Engagement member 87 may be circumferential or concentric about the access cuff 82, and may be a projection, detent, recess, threads, interference fits, or the like.
  • the engagement member is a fluorinated ethylene propylene (FEP) ring or helix on an outer circumferential surface near the distal end of the access graft 82.
  • FEP fluorinated ethylene propylene
  • the axial compression cuff 85 has an annular 6551-016.PCT_IntApp.docx 17 Attorney Docket No.: 6551-016.PCT Customer No.29,335 opening that couples concentrically with the outer circumferential aspect of the access cuff and is configured to engagement with engagement member 86.
  • Axial compression cuff 85 may, optionally, have one or more distally extending flanges 89 that are configured to nest against an abluminal wall of the blood vessel and, via interface with engagement member 87, exert an axially compressive force against the abluminal surface of the blood vessel 2 about the access site 8, at least one flange 84, and the reinforcing member 86, with the blood vessel 2 being between the axial compression cuff 85 and the at least one flange 84.
  • This configuration and the axial compression creates a hemostatic seal about the access site 8 without the need for suturing.
  • Access device and assembly 110 is graft agnostic in that it is configured for use with or without an access graft.
  • Access device and assembly 110 consists generally of a ring 120 having a plurality of plurality of tines 123 arrayed about a circumference of ring 120 and initially projecting parallel to a longitudinal axis of the ring 120.
  • Ring 120 is preferably made of a shape memory material, such as a shape memory metal alloy or a shape memory polymer.
  • the programmed shape of ring 120 allows for the ring 120 to be diametrically expandable and capable of annularly everting about its longitudinal axis or of a fixed diameter and capable of annularly everting about its longitudinal axis.
  • the ring 120 By configuring the ring 120 to be diametrically expandable, the ring 120 is adapted to expand to allow a catheter-based medical device to be passed through ring 120, access site 8, and into the lumen of blood vessel 2. Moreover, diametrically expandable ring 120 will then diametrically contract about an outer circumference of the catheter-based medical device to impart a seal about the catheter-based medical device.
  • the everting characteristic of ring 120 allows the plurality of tines to have a first state in which they are oriented distally and configured to engage with the abluminal wall tissue of the blood vessel, with the annulus of ring 120 open to allow for the blood vessel 2 tissue to be pulled through the ring 120 with the plurality of tines 6551-016.PCT_IntApp.docx 18 Attorney Docket No.: 6551-016.PCT Customer No.29,335 123 rotating about their axis as the blood vessel 2 tissue is pulled through the annulus.
  • the plurality of tines 123 upon opening the vascular access site, such as by a venotomy or arteriotomy, the plurality of tines 123 will complete their eversion and be oriented in their second state where the plurality of tines 123 have rotated about 180 degrees and oriented proximally with the vascular tissue embedded by the plurality of tines 123 now being everted such that abluminal wall of the blood vessel is everted upon itself and the luminal wall surface of the blood vessel 2 is exposed with the plurality of tines 123 protruding from the exposed luminal wall surface.
  • the ring 120 may be used with or without a graft.
  • Figures 13a-13c illustrate the sequential steps of engaging the plurality of tines 123 of ring 120 with the blood vessel with the plurality of tines distally oriented to engage the abluminal wall of the blood vessel, then pulling the abluminal surface of the blood vessel to become the vascular access site 8 through the ring 120, and creating the vascular access site 8 by arteriotomy or venotomy, and allowing the ring 120 to evert such that the plurality of tines 123 become oriented in an opposite and proximal orientation.
  • Figures 14a-14d illustrate the sequential steps of joining a graft 102 to a blood vessel 2 about an access site 8, with the eversion of the ring 120 such that the plurality of tines 123 rotate from a distal orientation toward the lumen of the blood vessel 2 to a proximal orientation away from the lumen of the blood vessel and parallel to the longitudinal axis of the graft 102.
  • Fig.15 further depicts an assembly 120 in which the ring 120 is engaged about a distal circumference of a graft 112 and proximal to a distal flange 114 at the distal end of the graft 112.
  • the plurality of tines When everted 121, the plurality of tines form the eversion in the blood vessel 2 about the circumference of ring 120 and about the circumference of the access site.
  • the distal flange 114 is supported by reinforcement member 116 against the luminal wall surface of the blood vessel 2.
  • An axial compression member 122 is concentrically engaged about the graft 112 and brought into engagement with the plurality of tines 123 to both cover the plurality of tines 123 and exert an axially compressive force to the ring 120 and the reinforcement member 116 coupled to the distal flange 114, which seals the access site between the axial compression member 122 and the distal flange 114 and allows communication between the graft 112 and the lumen of the blood vessel 2.
  • an engagement member (not shown) similar to engagement member 87 in Fig.10 may be provided proximate to the distal end of the graft 112.
  • the engagement member may be circumferential or concentric about the access graft 112, and may be a projection, detent, recess, threads, interference fits, or the like.
  • the engagement member is a fluorinated ethylene propylene (FEP) ring or helix on an outer circumferential surface near the distal end of the access graft 112.
  • FEP fluorinated ethylene propylene
  • the axial compression member 122 has an annular opening that couples concentrically with the outer circumferential aspect of the access graft 112 and is configured to engage with the engagement member.
  • Axial compression member 122 may, optionally, have one or more distally extending flanges that are configured to nest against an abluminal wall of the blood vessel and, via interface with the engagement member, exert an axially compressive force against the abluminal surface of the blood vessel 2 about the access site 8. This configuration and the axial compression creates a hemostatic seal about the access site 8 without the need for suturing.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un dispositif et un ensemble d'accès vasculaire caractérisés par un greffon d'accès tubulaire ayant au moins une bride distale inclinée qui forme une ouverture distale non circulaire vers le greffon d'accès tubulaire, la bride distale inclinée ayant une structure de renforcement qui étend la bride et vient en butée contre une surface de paroi luminale d'un vaisseau sanguin. Éventuellement, un anneau ou un manchon de compression axiale peut être fourni, lequel vient en prise de manière concentrique avec le greffon d'accès tubulaire et peut être déplacé en translation dans une position qui vient en butée contre une surface de paroi abluminale du vaisseau sanguin. Également éventuellement, le dispositif et l'ensemble peuvent comprendre une bague annulaire avec une pluralité de dents faisant saillie axialement agencées en réseau autour d'une circonférence de la bague annulaire, la bague annulaire étant conçue pour se retourner lors de la mise en prise avec un tissu vasculaire et la création d'un accès ouvert par artériotomie ou veinotomie. La pluralité de dents est conçue pour venir en prise avec un tissu vasculaire et ensuite tourner vers une orientation axiale différente pour retourner la périphérie du site d'accès. La pluralité de dents peut être utilisée pour coupler un greffon dans une anastomose termino-latérale ou être utilisée sans greffon pour renforcer le site d'accès et permettre ensuite la fermeture du site d'accès. Le dispositif et l'ensemble d'accès vasculaire sont particulièrement utiles pour fournir un accès à une artère axillaire afin d'introduire un dispositif médical, tel qu'un dispositif d'assistance ventriculaire à écoulement axial basé sur un cathéter, dans et à travers l'artère axillaire et dans le coeur.
PCT/US2024/047455 2023-09-19 2024-09-19 Dispositif, système et procédé d'accès, pour anastomose côté extrémité, à une vascularisation périphérique Pending WO2025064653A2 (fr)

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Application Number Priority Date Filing Date Title
US202363583751P 2023-09-19 2023-09-19
US202363583852P 2023-09-19 2023-09-19
US63/583,852 2023-09-19
US63/583,751 2023-09-19

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WO2025064653A3 WO2025064653A3 (fr) 2025-05-08

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PCT/US2024/047455 Pending WO2025064653A2 (fr) 2023-09-19 2024-09-19 Dispositif, système et procédé d'accès, pour anastomose côté extrémité, à une vascularisation périphérique

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Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5755778A (en) * 1996-10-16 1998-05-26 Nitinol Medical Technologies, Inc. Anastomosis device
US20050038498A1 (en) * 2003-04-17 2005-02-17 Nanosys, Inc. Medical device applications of nanostructured surfaces
US9282967B2 (en) * 2007-08-02 2016-03-15 Bioconnect Systems, Inc. Implantable flow connector
US9055946B2 (en) * 2008-11-26 2015-06-16 Phraxis Inc. Anastomotic connector
WO2012019126A1 (fr) * 2010-08-06 2012-02-09 Heartware, Inc. Dispositif de conduit destiné à être utilisé avec un dispositif d'assistance ventriculaire
GB2515731A (en) * 2013-06-18 2015-01-07 Vascutek Ltd Prosthesis
CN110997036A (zh) * 2017-06-19 2020-04-10 加利福尼亚大学董事会 用于无创和经皮形成动静脉瘘的装置和方法

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