Devices and methods for closure of transvascular or transcameral access ports

• US 10,045,765 B2
• Filed: 07/31/2017
• Issued: 08/14/2018
• Est. Priority Date: 03/27/2014
• Status: Active Grant

• Current Assignee: Transmural Systems LLC, United States Department Of Health And Human Services
• Original Assignee: Transmural Systems LLC, United States Department Of Health And Human Services
• Inventors: Rafiee, Nasser, MacDonald, Stuart, Lederman, Robert J., Rogers, Toby, Busold, Rany, Rafiee, Koosha
• Primary Examiner(s): STRANSKY, KATRINA MARIE
• Application Number:
  US15/664,642
• Publication Number:
  US 20180008248A1
• Time in Patent Office: 379 Days
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/1215 comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/00601 Implements entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00641 for closing fistulae, e.g. anorectal fistulae
• CPC Class Codes: A61B 2017/00964 composite
• CPC Class Codes: A61B 2017/00991 Telescopic means
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/3425 for internal organs, e.g. heart ports
• CPC Class Codes: A61B 2090/376 : using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 2090/3966 : Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61F 2/0077 : Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/88 : the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/90 : characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2230/0078 : hyperboloidal
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers

Abstract

The present disclosure provides a variety of prostheses, delivery systems and techniques to facilitate closure of transvascular or transcameral access ports. Various embodiments of prostheses are provided including a plurality of radially expandable discs that can be filled with material to facilitate coagulation and to reduce or stop leakage from punctures in vessel walls.

Claims

1. A prosthesis having a proximal end and a distal end, the prosthesis having a radially expandable body, the radially expandable body being configured to expand into at least one distal disc after becoming unconstrained, the at least one distal disc including a radially outwardly extending paddle attached to the at least one distal disc, the paddle being configured to assume a radial orientation as the at least one distal disc expands outwardly radially, the paddle being configured to extend radially outwardly beyond an outer circumferential perimeter of the at least one disc, the paddle being defined by a framework that is structurally distinct from and attached to the structure of the at least one distal disc, said framework extending from a radially inboard location of the at least one distal disc to a radial outward tip, a radially inboard portion of the paddle being configured and arranged to reside near an edge of an opening in a lumenal wall when the prosthesis is deployed in order to facilitate confirmation of the location of the opening in the lumenal wall in which the prosthesis is positioned, said paddle being configured and arranged to help to seat the prosthesis in the opening when the prosthesis is attached to a delivery catheter, and to provide resistance to help prevent the prosthesis from being pulled through the opening.

2. The prosthesis of claim 1, wherein the at least one distal disc is formed from a braided mesh body formed from a plurality of filaments that can slide across one another during expansion, the at least one distal disc defining a volume therein, and wherein the prosthesis further comprises a resilient member distinct from the braided mesh body, the resilient member being attached to a proximal region and a distal region of the prosthesis along an axis that defines a central region of the prosthesis, the resilient member being configured to cause the prosthesis to shorten along the axis and expand radially when the resilient member is relaxed, wherein the resilient member and paddle cooperate to prevent the prosthesis from being pulled through a hole formed in a wall of a body lumen.

3. The prosthesis of claim 2, wherein the prosthesis includes a material disposed within the mesh body that is configured to encourage hemostasis when exposed to blood.

4. The prosthesis of claim 2, further comprising at least one radially expandable proximal disc connected to the resilient member, the resilient member causing the at least one radially expandable proximal disc and for a neck region of the prosthesis separating the discs to both expand radially outwardly when the resilient member is unconstrained and permitted to shorten axially.

5. The prosthesis of claim 4, further comprising an outer annular fabric section extending between and joining the at least one distal disc and the at least one radially expandable proximal disc, the outer annular fabric section surrounding a portion of the resilient member disposed between the at least one distal disc and the at least one radially expandable proximal disc.

6. The prosthesis of claim 5, wherein the outer annular fabric section extends to the full radial extent of an inwardly facing face of each of said discs.

7. The prosthesis of claim 5, further comprising at least one length limiting tether disposed radially outwardly with respect to said outer annular fabric section, said at least one length limiting tether being configured and arranged to prevent the resilient member from stretching beyond a predetermined length.

8. The prosthesis of claim 1, wherein said framework includes a wire structural frame that is covered with fabric material that is configured to enhance tissue ingrowth into the paddle, wherein the fabric material is disposed at least on a face of the paddle that faces proximally when deployed so as to face a vessel wall when implanted to facilitate tissue ingrowth into the paddle.

9. The prosthesis of claim 1, wherein the prosthesis includes at least one radiopaque marker disposed on the radially inboard portion of the paddle, the radiopaque marker being positioned so as to be located at the opening in the lumenal wall to indicate to a physician that the prosthesis is positioned correctly within the opening in the vessel wall, wherein the radiopaque marker is positioned proximate a surface of a necked down section of the prosthesis that is located proximally with respect to the at least one distal disc.

10. A system for delivering a prosthesis according to claim 4, comprising:

a) an outer tubular member having a proximal end and a distal end and defining a first lumen therethrough along at least a portion of the outer tubular member, the distal end of the outer tubular member being cut at an angle that is oblique with respect to a central axis defined by the system, the distal end further including a radiopaque marker proximate the distal end making the angle at which the distal end is cut being visible under fluoroscopy to help reduce canting of the prosthesis during implantation;

b) an intermediate tubular member disposed at least partially within the first lumen and being slidably disposed with respect to the outer tubular sheath, the intermediate tubular member having a proximal end, a distal end, and a flexible distal portion configured to be protrudable distally beyond the distal end of the outer tubular sheath, the intermediate tubular member defining a second lumen therethrough along at least a part of the length of said intermediate tubular member, the flexibility of said distal portion of the intermediate tubular member being configured and adapted to permit the intermediate tubular member to be deformed into a reverse curved geometry with respect to a central axis of a proximal portion of the delivery system while inside a patient'"'"'s lumen;

c) an inner elongate member disposed at least partially within the second lumen, the inner elongate member being slidably disposed with respect to the intermediate tubular member, the inner elongate member having a proximal end and a distal end configured to be displaced distally beyond the distal end of the intermediate tubular member, wherein the inner elongate member is a tubular member configured to permit a guidewire to pass therethrough, and further wherein the distal end of the inner elongate member is configured to abut against an inner face of an end region of the prosthesis to form a guidewire lumen to permit the guidewire passing through the inner elongate member to pass through a distal face of the prosthesis; and

d) a prosthesis according to claim 3 removably mounted on the distal end of the intermediate tubular member, wherein the prosthesis can be longitudinally stretched by advancing the inner elongate member distally with respect to the intermediate tubular member and against the inner face of the end region of the prosthesis, and further wherein said longitudinal stretch of said prosthesis causes the prosthesis to collapse radially inwardly to permit said prosthesis to be withdrawn into said distal end of said outer tubular sheath.

11. The system of claim 10, wherein the resilient member of the prosthesis is a coil spring that causes the prosthesis to collapse axially and the discs to expand radially to prevent the prosthesis from being pulled axially through an anatomical opening it has been delivered through after it has been deployed.

12. The system of claim 10, wherein the system is configured and arranged to cause the paddle of the prosthesis to be urged against an inner wall of a lumen adjacent an opening in the lumen in which a portion of the prosthesis is situated to cause the at least one distal disc to come into parallel alignment with the inner wall of the lumen and prevent the at least one distal disc from becoming canted in the lumen when said intermediate tubular member is bent into the reverse curved geometry.

13. A prosthesis comprising:

a) a plurality of radially expandable braided mesh bodies connected by mesh material, each of said bodies being formed from a plurality of filaments that can slide across one another, each of the braided mesh bodies being configured to self-expand into at least one disc, each radially expandable braided mesh body defining a volume therein;

b) a resilient member structurally distinct from the mesh material, a proximal portion of said resilient member being connected to a proximal portion of a proximal radially expandable braided mesh body of the plurality of radially expandable braided mesh bodies, a distal portion of said resilient member being connected to a distal portion of a distal radially expandable braided mesh body of the plurality of radially expandable braided mesh bodies, the proximal and distal radially expandable braided mesh bodies being spaced from one another along a central longitudinal axis of the prosthesis, the resilient member being configured to cause the prosthesis to shorten along the axis to cause the plurality of radially expandable braided mesh bodies to expand radially outwardly when the resilient member is relaxed; and

c) an outer fabric covering connecting the plurality of radially expandable braided mesh bodies, the outer fabric being disposed outside of the braiding of the plurality of radially expandable braided mesh bodies.

14. The prosthesis of claim 13, wherein the prosthesis defines a lumen of substantially constant diameter along its length through both discs along an axial centerline of the prosthesis, the lumen being configured and arranged to act as an adjustable shunt having an adjustable length when the prosthesis is deployed to connect two lumens.

15. The prosthesis of claim 13, wherein the outer fabric is annularly shaped and is configured to surround at least a portion of the resilient member disposed in a neck region of the prosthesis spanning between the radially expandable braided mesh bodies, such that the fabric in the neck region expands radially outwardly when the resilient member is unconstrained to facilitate achievement of hemostasis.

16. The prosthesis of claim 15, wherein the outer fabric extends between and connects a distal face of the proximal radially expandable braided mesh body to a proximal face of the distal radially expandable braided mesh body.

17. The prosthesis of claim 16, further comprising at least one interior fabric layer disposed within at least one of the plurality of radially expandable braided mesh bodies, wherein the interior fabric layer is substantially radially coextensive with at least one of the radially expandable braided mesh bodies.

18. The prosthesis of claim 13, further comprising at least one length limiting tether disposed radially outwardly of at least a portion of the outer fabric of the prosthesis, said at least one length limiting tether connecting said proximal radially expandable braided mesh body to said distal radially expandable braided mesh body, said at least one length limiting tether being configured and arranged to prevent said resilient member from stretching beyond a predetermined length.

19. A system for delivering a prosthesis according to claim 13, comprising:

a) an outer tubular member having a proximal end and a distal end and defining a first lumen therethrough along at least a portion of the length of the outer tubular sheath, the distal end of the outer tubular member being cut at an angle that is oblique with respect to a central axis defined by the system, the distal end further including a radiopaque marker proximate the distal end making the angle at which the distal end is cut being visible under fluoroscopy to help reduce canting of the prosthesis during implantation;

b) an intermediate tubular member disposed at least partially within the first lumen and being slidably disposed with respect to the outer tubular sheath, the intermediate tubular member having a proximal end, a distal end, and a flexible distal portion configured to be protrudable distally beyond the distal end of the outer tubular sheath, the intermediate tubular member defining a second lumen therethrough along at least a part of the length of the intermediate tubular member, the flexibility of the distal portion of the intermediate tubular member being configured and adapted to permit the intermediate tubular member to be deformed into a reverse curved geometry with respect to a central axis of a proximal portion of the delivery system while inside a patient'"'"'s lumen;

c) an inner elongate member being disposed at least partially within the second lumen, the inner elongate member being slidably disposed with respect to the intermediate tubular member, the inner elongate member having a proximal end and a distal end configured to be displaced distally beyond the distal end of the intermediate tubular member, wherein the inner elongate member is a tubular member configured to permit a guidewire to pass therethrough, and further wherein the distal end of the inner elongate member is configured to abut against an inner face of an end region of the prosthesis to form a guidewire lumen to permit the guidewire passing through the inner elongate member to pass through a distal face of the prosthesis; and

d) a prosthesis according to claim 13 removably mounted on the distal end of the intermediate tubular member, wherein the prosthesis can be longitudinally stretched by advancing the inner elongate member distally with respect to the intermediate tubular member and against the inner face of the end region of the prosthesis, and further wherein said longitudinal stretch of said prosthesis causes the prosthesis to collapse radially inwardly to permit said prosthesis to be withdrawn into said distal end of said outer tubular sheath.

20. A prosthesis comprising:

a) a plurality of radially expandable braided mesh bodies that are configured to self-expand into a plurality of discs after becoming radially unconstrained, said plurality of radially expandable mesh bodies defining at least one volume therein when expanded and further defining an open channel along a central axis of the prosthesis through the plurality of radially expandable mesh bodies to permit a guidewire passing through the open channel to pass through a distal face of the prosthesis; and

b) a tension coil spring attached to a proximal portion of a proximal one of said discs, and to a distal portion of a distal one of said discs, the tension coil spring being configured to cause the prosthesis to shorten along the central axis and for the plurality of radially expandable braided mesh bodies to expand radially when the tension coil spring is relaxed, the tension coil spring having at least one section with a diameter that is larger than proximal and distal central openings defined at a proximal end of a proximal disc and a distal end of the distal disc, respectively, to prevent the coil spring from extending outwardly through the central openings of the prosthesis.

21. The prosthesis of claim 20, wherein the at least one volume includes a beneficial agent disposed therein.

22. The prosthesis of claim 21, wherein the beneficial agent includes a coagulating gel.

23. The prosthesis of claim 21, wherein the beneficial agent includes a pharmaceutical compound.

24. The prosthesis of claim 20, further comprising at least one length limiting tether disposed radially outwardly of an outer surface of the prosthesis, said at least one length limiting tether connecting said mesh bodies to one another, the at least one length limiting tether being configured and arranged to prevent the resilient member from stretching beyond a predetermined length.

25. A system for delivering a prosthesis, comprising:

a) a prosthesis, including a plurality of radially expandable braided mesh bodies that are configured to self-expand into a plurality of discs after becoming radially unconstrained, each radially expandable mesh body defining a volume therein when expanded, and a tension coil spring connected to a proximal portion of a proximal one of said discs, and connected to a distal portion of a distal one of said discs, the tension coil spring being configured to pull axially inwardly on said proximal portion and said distal portion to cause said prosthesis to shorten along a central axis and for the plurality of radially expandable braided mesh bodies to expand radially when the tension coil spring is relaxed; and

b) a delivery system for delivering the prosthesis, comprising;

i) an outer tubular member having a proximal end and a distal end and defining a first lumen therethrough along at least a portion of its length; and

ii) an inner elongate member being disposed at least partially within the first lumen, the inner elongate member being slidably disposed with respect to the outer tubular member, the inner elongate member having a proximal end and a distal end configured to be displaced distally beyond the distal end of the outer tubular member, wherein the inner elongate member is a tubular member configured to permit a guidewire to pass therethrough, and further wherein a distal end of the inner elongate member is configured to abut against a distal portion of the prosthesis to form a guidewire lumen to permit the guidewire passing through the inner elongate member to pass through a distal face of the prosthesis, wherein the prosthesis can be longitudinally stretched by advancing the inner elongate member distally with respect to the outer tubular member and against the distal portion of the prosthesis, and further wherein said longitudinal stretch of said prosthesis causes the prosthesis to collapse radially inwardly to permit said prosthesis to be withdrawn into said distal end of said outer tubular member.