Intravascular folded tubular endoprosthesis

• US 6,287,335 B1
• Filed: 04/26/1999
• Issued: 09/11/2001
• Est. Priority Date: 04/26/1999
• Status: Expired due to Fees

• Current Assignee: Joseph M. Thielen, William J. Drasler
• Original Assignee: Joseph M. Thielen, William J. Drasler
• Inventors: Drasler, William J., Thielen, Joseph M.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US09/299,512
• Time in Patent Office: 869 Days
• Field of Search: 623/1.28, 623/1.13, 623/1.14, 623/1.29, 623/1.35, 623/1.36, 604/271
• US Class Current: 623/1.28
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0007 for adjusting length

Abstract

A bifurcated or straight intravascular folded tubular member is deliverable percutaneously or by small cutdown to the site of a vascular lesion. Its inserted state has a smaller nondeployed diameter and a shorter nondeployed length. The intravascular tubular member has a folded tubular section that is unfolded following insertion into the blood vessel. The length of the intravascular folded tubular member is sized in situ to the length of the vessel lesion without error associated with diagnostic estimation of lesion length. The folded tubular member is self-expandable or balloon-expandable to a larger deployed diameter following delivery to the lesion site. An attachment anchor can be positioned at the inlet or outlet ends of the intravascular folded tubular member to prevent leakage between the tubular member and the native vessel lumen and to prevent migration of the tubular member. The attachment anchor has a short axial length to provide a more focal line of attachment to the vessel wall. Such attachment is valuable in attaching to a short aortic neck in the treatment of abdominal aortic aneurysm. The attachment anchor can have barbs which are held in a protected conformation during insertion of the tubular member and are released upon deployment of the attachment anchor. The intravascular tubular member can be formed of woven multifilament polymeric strands with metallic strands interwoven along with them. Double weaving is incorporated to prevent leakage at crossover points.

Claims

1. An intravascular tubular member for use in treatment of an injured artery that conveys blood flow from a proximal arterial region proximal to the injured artery to one or more distal arterial vessels and is introduced in an nondeployed state with a smaller nondeployed diameter through an artery that supplies blood to or receives blood from the injured artery and expands upon deployment to a larger deployed diameter and is implanted in a fully deployed state, said intravascular tubular member comprising;

A. a proximal tubular section with an open free inlet end to provide passage for blood flow into said intravascular tubular member from the proximal arterial region;

B. one or more distal tubular sections, each of said one or more distal tubular sections having an open free outlet end to provide passage of blood flow out of said intravascular tubular member to one or more distal arterial vessels;

C. an intravascular tubular member wall extending between said inlet end of said proximal tubular section and said outlet end of each of said one or more distal tubular sections;

D. one or more folded tubular sections, each of said one or more folded tubular sections having an upstream end and a downstream end, said upstream end of each of said one or more folded tubular sections being joined to said proximal tubular section and said downstream end of each of said one or more folded tubular sections being joined to one of said one or more distal tubular sections, each of said one or more folded tubular sections having said intravascular tubular member wall folded back and forth upon itself forming an inner wall, a center wall, and an outer wall;

whereby said intravascular tubular member extends in an axial length from said inlet end to said outlet end during the deployment from the nondeployed state to the fully deployed state as said center wall decreases in length.

2. The intravascular tubular member of claim 1 for use in the treatment of an injured artery further comprising an inlet attachment means positioned at said inlet end to hold said intravascular tubular member into contact with the proximal arterial region, said attachment means having a smaller nondeployed diameter and a larger deployed diameter.

3. The intravascular tubular member of claim 2 further comprising an outlet attachment means positioned at said outlet end of at least one of said one or more distal tubular sections to hold said intravascular tubular member into contact with the one or more distal arterial vessels.

4. The intravascular tubular member of claim 3 wherein said outlet attachment means is comprised of hinges and struts, said hinges and struts being connected to each other to form a circular band shape, said hinge having a hinge width that is smaller than a strut width.

5. The intravascular tubular member of claim 4 wherein at least one of said outlet attachment means comprises a barb which extends outwardly during the deployment of said outlet attachment means.

6. The intavascular tubular member of claim 2 wherein said inlet attachment means is comprised of hinges and struts, said hinges and struts being connected to each other to form a circular band shape, said hinge having a hinge width that is smaller than a strut width.

7. The intravascular tubular member of claim 6 wherein said inlet attachment means comprises at least one elastically deformed barb which is held in a nondeployed position by at least one of said struts of said attachment means and is released by at least one of said struts to allow said barb to extend outward elastically during the deployment of said attachment means.

8. The intravascular tubular member of claim 6 wherein said struts are attached to said hinges via transition regions, said attachment means being further comprised of at least one elastically deformed barb which is held in a nondeployed position by one or more of said transition regions and are released by one or more of said transition regions to allow said barb to extend outwardly elastically during the deployment of said attachment means.

9. The attachment means of claim 6 wherein said hinge undergoes a plastic deformation as said attachment means undergoes the expansion deformation from a smaller diameter in a nondeployed state to a larger diameter in a deployed state.

10. The attachment means of claim 6 wherein said hinge undergoes an elastic deformation as said attachment means undergoes the expansion deformation from a smaller diameter in a nondeployed state to a larger diameter in a deployed state.

11. The intravascular tubular member of claim 2 wherein said inlet attachment means comprises one or more barbs that extend outwardly during deployment of said inlet attachment means.

12. The intravascular tubular member of claim 2 wherein said attachment means undergoes a plastic deformation in going from a smaller nondeployed diameter to a larger deployed diameter.

13. The intravascular tubular member of claim 2 wherein said attachment means undergoes an elastic deformation in going from a smaller nondeployed diameter to a larger deployed diameter.

14. The intravascular tubular member of claim 1 wherein;

A. said one or more distal tubular sections comprises one distal tubular section, said distal tubular section having an outlet end to provide passage of blood flow out of said intravascular tubular member to a distal arterial vessel;

B. said one or more folded tubular sections comprises one folded tubular section, said folded tubular section having an upstream end and a downstream end, said upstream end being joined to said proximal tubular section and said downstream end being joined to said distal tubular section, said folded tubular section having said intravascular tubular member wall folded back and forth upon itself forming an inner wall, a center wall, and an outer wall.

15. The intravascular tubular member of claim 1 for use in the treatment of abdominal aortic aneurysm wherein;

A. said one or more distal tubular sections comprise two distal tubular sections, each of said two distal tubular sections having an outlet end to provide passage of blood flow out of said intravascular tubular member to two distal arterial vessels;

B. said one or more folded tubular sections comprise two folded tubular sections, each of said two folded tubular sections having an upstream end and a downstream end, said upstream end of each of said two folded tubular sections being joined to said proximal tubular section and said downstream end of each of said two folded tubular sections being joined to one of said two distal tubular sections, each of said two folded tubular sections having said intravascular tubular member wall folded back and forth upon itself forming an inner wall, a center wall, and an outer wall.

16. The intravascular tubular member of claim 15 further comprising an inlet attachment means positioned at said inlet end to hold said intravascular tubular member into contact with the proximal arterial region.

17. The intravascular tubular member of claim 15 further comprising an outlet attachment means positioned at said outlet end of each of said two distal tubular sections to hold said intravascular tubular member into contact with the two distal arterial vessels.

18. The intravascular tubular member of claim 1 further comprising a bonding agent placed within at least one of said one or more folded tubular sections.

19. The intravascular tubular member of claim 1 wherein a holding means is placed in said one or more folded tubular sections in a deployed state to prevent unfolding of said folded tubular section.

20. The intravascular tubular member of claim 19 wherein said holding means comprises one or more holding pins which penetrate through two or more walls of said folded tubular section.

21. The intravascular tubular member of claim 1 wherein said intravascular tubular member wall is comprised of polymeric multifilament strands woven in a generally circumferential direction and woven in the axial direction, said multifilament strands providing for sealing against blood leakage at crossover points and preventing blood leakage and tear propagation due to strand breakage.

22. The intravascular tubular member of claim 21 wherein said intravascular tubular member wall is further comprised of metallic monofilament strands woven along with said polymeric multifilament strands in a generally circumferential direction, said metallic strands woven in a generally circumferential direction providing outward expansion force for a thin wall thickness and provide for kink resistance.

23. The intravascular tubular member of claim 22 further comprising metallic monofilament strands woven along with said polymeric multifilament strands in a generally axial direction, said metallic strands woven in a generally axial direction providing axial compressive strength for a thin wall thickness.

24. The intravascular tubular member of claim 23 for intravascular use within a blood vessel wherein at least a fractional number of said metallic monofilament strands extend proximally beyond an inlet end of the intravascular tubular member and are attached to an attachment means that attaches said metallic monofilament strands to the proximal arterial region remote from and proximal to said inlet end of said intravascular tubular member.

25. The intravascular tubular member of claim 21 wherein said polymeric multifilament strands are formed from a polymer taken from the group which includes expanded polytetrafluoroethylene, polyester, polyurethane, silicone, and copolymers of these polymers.

26. The intravascular tubular member of claim 25 comprised of woven expanded polytetrafluoroethylene multifilament strands in a generally axial and generally circumferential direction, said expanded polytetrafluoroethylene multifilament strands providing for resistance to leakage at crossover points, and said woven structure providing for safety due to a resistance to tear propagation.

27. The vascular tubular member of claim 21 wherein said expanded polytetrafluoroethylene multifilament strands woven in the axial direction are comprised of expanded polytetrafluoroethylene filaments, said expanded polytetrafluoroethylene filaments being comprised of polytetrafluoroethylene microfilaments having a curved structure to provide a stretch characteristic to said expanded polytetrafluoroethylene multifilament strands, to provide the vascular tubular member with kink resistance, and to provide compliance to the vascular tubular member.

28. The vascular tubular member of claim 21 wherein said expanded polytetrafluoroethylene multifilament strands woven in the circumferential direction are comprised of expanded polytetrafluoroethylene filaments, said expanded polytetrafluoroethylene filaments being comprised of polytetrafluoroethylene microfilaments having a curved structure to provide a stretch characteristic to said expanded polytetrafluoroethylene multifilament strands, to provide intravascular tubular member with kink resistance, and to provide compliance to the vascular tubular member.

29. The intravascular tubular member of claim 1 wherein said intravascular tubular member wall is comprised of polymeric multifilament strands braided in a right hand and left hand spiral, said multifilament strands providing for sealing against blood leakage at crossover points and preventing blood leakage and tear propagation due to strand breakage.

30. The intravascular tubular member of claim 29 wherein said intravascular tubular member wall is further comprised of metallic monofilament strands braided in a right hand and left hand spiral along with said polymeric multifilament strands, said metallic monofilament strands providing outward expansion force for a thin wall thickness and provide for kink resistance.

31. The intravascular tubular member of claim 29 wherein said polymeric multifilament strands are formed from a polymer taken from the group which includes expanded polytetrafluoroethylene, polyester, polyurethane, silicone, and copolymers of these polymers.

32. An intravascular tubular member for use in treatment of an injured artery that conveys blood flow from a proximal arterial region proximal to the injured artery to one or more distal arterial vessels and is introduced in an nondeployed state with a smaller nondeployed diameter through an artery that supplies blood to or receives blood from the injured artery and expands upon deployment to a larger deployed diameter and is implanted in a deployed state, said intravascular tubular member comprising;

A. a proximal tubular section with an inlet end to provide passage for blood flow into said intravascular tubular member from the proximal arterial region;

B. one or more distal tubular sections, each of said one or more distal tubular sections having an outlet end to provide passage of blood flow out of said intravascular tubular member to one or more distal arterial vessels;

C. said intravascular tubular member having an outer surface extending between said inlet end of said proximal tubular section and said outlet end of each of said one or more distal tubular sections;

D. one or more folded tubular sections, each of said one or more folded tubular sections having an upstream end and a downstream end, said upstream end of each of said one or more folded tubular sections being joined to said proximal tubular section and said downstream end of each of said one or more folded tubular sections being joined to each of said one or more distal tubular sections, each of said one or more folded tubular sections having a first portion of said outer surface in apposition with a second portion of said outer surface over an entire length of said folded tubular section, and both of said portions being nearly parallel to an axis of said folded tubular section;

whereby said intravascular tubular member can extend in an axial length from said inlet end to said outlet end during the deployment from the nondeployed state to the deployed state.

33. The intravascular tubular member of claim 32 wherein a bonding agent is placed between said first portion of said outer surface and said second portion of said outer surface.

34. An intravascular tubular member for implantable use within a human body for treatment of abdominal aortic aneurysm that conveys blood flow from a proximal aortic region proximal to an injured artery to one or more distal arterial vessels and is introduced in an nondeployed state with a smaller nondeployed insertion diameter using a minimally invasive vascular access through an artery that supplies blood to or receives blood from the aorta and expands upon deployment to a larger deployed diameter and is implanted within the human body in an implanted state, said intravascular tubular member comprising;

A. a proximal tubular section having an open free inlet end to provide passage for blood flow into said proximal tubular section from the proximal aorta, said proximal tubular section being joined to at least one folded tubular section, said at least one folded tubular section providing for a change in axial length for said intravascular tubular member, each of said at least one folded tubular section being joined to a distal tubular section, said distal tubular section having an outlet end to provide for passage of blood flow out of said distal tubular section into the one or more distal arterial vessels;

B. said at least one folded tubular section having said intravascular tubular member wall longitudinally overlapped in an axial direction whereby said at least one folded tubular section can unfold during deployment from the nondeployed state to the implanted state to provide a decrease in length of said at least one folded tubular section.

35. An intravascular tubular member for use in treatment of an injured artery that conveys blood flow from a proximal arterial region proximal to the injured artery to one or more distal arterial vessels and is introduced in an nondeployed state with a smaller nondeployed diameter through an artery that supplies blood to or receives blood from the injured artery and expands upon deployment to a larger deployed diameter and is implanted in a deployed state, said intravascular tubular member comprising;

A. a proximal tubular section with an open free inlet end to provide passage for blood flow into said intravascular tubular member from the proximal arterial region;

B. one or more distal tubular sections, each of said one or more distal tubular sections having an open free outlet end to provide passage of blood flow out of said intravascular tubular member to one or more distal arterial vessels;

C. an intravascular tubular member wall extending between said inlet end of said proximal tubular section and said outlet end of each of said one or more distal tubular sections;

D. one or more folded tubular sections, each of said one or more folded tubular sections having an upstream end and a downstream end, said upstream end of each of said one or more folded tubular sections being joined to said proximal tubular section and said downstream end of each of said one or more folded tubular sections being joined to one of said one or more distal tubular sections, each of said one or more folded tubular sections having said intravascular tubular member wall folded in a proximal and distal direction upon itself forming an inner wall, a center wall, and an outer wall, and said walls all being generally parallel to each other;

whereby said intravascular tubular member can extend in an axial length from said inlet end to said outlet end during the deployment from the nondeployed state to the fully deployed state.

36. A method of treatment of an injured artery that conveys blood flow from a proximal arterial region proximal to the injured artery to one or more distal arterial vessels and is introduced in an nondeployed state with a smaller nondeployed diameter through an artery that supplies blood to or receives blood from the injured artery and expands upon deployment to a larger deployed diameter and is implanted in a deployed state, the method comprising;

A. providing an intravascular tubular member in a non-radially deployed state and a non-axially deployed state into the vasculature, said intravascular tubular member having a proximal tubular section with an inlet end to provide passage for blood flow into said intravascular tubular member from the proximal arterial region and one or more distal tubular sections, each of said one or more distal tubular sections having an outlet end to provide passage of blood flow out of said intravascular tubular member to one or more distal arterial vessels, said intravascular tubular member having an intravascular tubular member wall extending between said inlet end of said proximal tubular section and said outlet end of each of said one or more distal tubular sections;

B. unfolding in an axial direction a portion of one or more folded tubular sections, each of said one or more folded tubular sections having an upstream end and a downstream end, said upstream end of each of said one or more folded tubular sections being joined to said proximal tubular section and said downstream end of each of said one or more folded tubular sections being joined to one of said one or more distal tubular sections, each of said one or more folded tubular sections having said intravascular tubular member wall folded proximally and distally upon itself forming an inner wall, a center wall, and an outer wall that are all generally parallel to each other;

whereby the unfolding of said one or more folded tubular sections provides said intravascular tubular member with a longer axial length.

37. The method of claim 36 wherein said intravascular tubular member is a one-piece structure that is continuous from the inlet end of said proximal tubular section to the outlet end of said one or more distal tubular sections.

38. The method of claim 36 wherein said intravascular tubular member is attached at a proximal end to the proximal arterial region using an inlet attachment means to hold the intravascular tubular member against the proximal arterial region prior to unfolding said one or more folded tubular sections.

39. The method of claim 38 wherein said one or more distal tubular sections are attached to the one or more distal arterial vessels following unfolding of said one or more folded tubular sections with an outlet attachment means to hold the intravascular tubular member against the one or more distal arterial vessels.

40. The method of claim 36 further comprising inserting a holding means after unfolding a portion of one or more folded tubular sections to hold together at least two walls of said one or more folded tubular sections and prevent further unfolding.

41. The method of claim 36 for treatment of abdominal aortic aneurysm wherein;

A. said one or more distal tubular sections comprise two distal tubular sections, each of said two distal tubular sections having an outlet end to provide passage of blood flow out of said intravascular tubular member to two distal arterial vessels;

B. said one or more folded tubular sections comprise two folded tubular sections, each of said two folded tubular sections having an upstream end and a downstream end, said upstream end of each of said two folded tubular sections being joined to said proximal tubular section and said downstream end of each of said two folded tubular sections being joined to one of said two distal tubular sections.

42. The method of claim 41 wherein said unfolding of said two folded tubular sections is attained via access through a single distal arterial vessel.

43. The method of claim 41 wherein one of said two folded tubular sections is unfolded via access from one of the distal arterial vessels and the other of said two folded tubular sections is unfolded via access through another of the distal arterial vessels.

44. A method of treatment of an abdominal aorta aneurysm that conveys blood flow from a proximal aortic region proximal to the abdominal aortic aneurysm to one or more distal arterial vessels and is introduced in an nondeployed state with a smaller nondeployed diameter using a minimally invasive vascular access through an artery that supplies blood to or receives blood from the aorta and expands upon deployment to a larger deployed diameter and is implanted in a deployed state, the method comprising;

A. providing an intravascular tubular member in a non-radially deployed state and a non-axially deployed state into the aortic vasculature, said intravascular tubular member having a proximal tubular section with an inlet end to provide passage for blood flow into said intravascular tubular member from the proximal aortic region and one or more distal tubular sections, each of said one or more distal tubular sections having an outlet end to provide passage of blood flow out of said intravascular tubular member to one or more distal arterial vessels, said intravascular tubular member having an intravascular tubular member wall extending between said inlet end of said proximal tubular section and said outlet end of each of said one or more distal tubular sections;

B. expanding the inlet end of said intravascular tubular member into contact with the proximal aortic region using an attachment means to hold the intravascular tubular member outwards against the proximal aortic region;

C. unfolding in an axial direction one or more folded tubular sections, each of said one or more folded tubular sections having an upstream end and a downstream end, said upstream end of each of said one or more folded tubular sections being joined to said proximal tubular section and said downstream end of each of said one or more folded tubular sections being joined to one of said one or more distal tubular sections, each of said one or more folded tubular sections having said intravascular tubular member wall folded back and forth upon itself forming an inner wall, a center wall, and an outer wall that are all generally parallel to an each other;

D. expanding the outlet end of said one or more distal tubular sections into contact with the one or more distal arterial vessels using an attachment means to hold the intravascular tubular member outwards;

whereby the unfolding of said one or more folded tubular sections provides said intravascular tubular member with a longer axial length.