Expandable transluminal graft prosthesis for repairs of aneurysm and method for implanting

• US 5,456,713 A
• Filed: 11/30/1993
• Issued: 10/10/1995
• Est. Priority Date: 10/25/1991
• Status: Expired due to Term

• Current Assignee: Cook Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Chuter, Timothy
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): BRITTINGHAM, DEBRA
• Application Number:
  US08/159,774
• Time in Patent Office: 679 Days
• Field of Search: 623/1, 623/11, 623/12, 606/191, 606/192, 606/193, 606/194, 606/195-198, 604/96, 604/8, 600/36
• US Class Current: 623/1.23
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• 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 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

A transluminal grafting system for grafting a prosthesis to the wall of a lumen includes a tubular graft provided with spring assemblies and anchoring barbs. The prothesis is mounted on an apertured tubular carrier and a central control means is inserted into the bore of the apertured carrier. Mooring loops are attached to the prothesis, pass through the apertures of the tubular carrier, and engage the central control means. An introducer sheath covers the system for smooth insertion into a lumen. When the graft has been positioned, the central control means maintains the axial position of the prosthesis. When the introducer sheath is pulled, the prostheis is exposed and the spring assemblies return to an expanded state and anchor the graft against the internal wall of the lumen.

Claims

1. A device for grafting a prosthesis to a wall of a lumen, said device comprising:

a) a tubular introducer sheath having a longitudinal bore;

b) a prosthesis comprising a tubular graft having a longitudinal bore and disposed in the longitudinal bore of said tubular introducer sheath, said graft being expandable radially to substantially conform to an interior wall of a lumen;

a self expanding spring assembly having a compressed state and attached to said tubular graft for expanding said graft so that it substantially conforms to an interior wall of a lumen after said introducer sheath has been removed from said self expanding spring assembly, said introducer sheath containing said self expanding spring assembly in said compressed state when said spring assembly is positioned in said longitudinal bore of said introducer sheath; and

anchoring means for attaching said graft to an interior wall of a lumen;

c) tubular carrier means having a longitudinal bore and disposed in the longitudinal bore of said tubular graft, said carrier means also having a plurality of apertures;

d) central control means for maintaining an axial position of said prosthesis during removal of said introducer sheath, said central control means being disposed in the longitudinal bore of said tubular carrier means; and

e) mooring loops engaging said prosthesis and passing through said apertures in said tubular carrier means to engage said central control means.

2. The device of claim 1 further comprising a dilator at one end of said tubular introducer sheath.

3. The device of claim 1 wherein said self expanding spring assembly comprises a plurality of spring frames.

4. The device of claim 3 wherein said spring frames are attached to the inside of said tubular graft.

5. The device of claim 3 wherein said spring frames are attached to the outside of said tubular graft.

6. The device of claim 1 wherein said anchoring means comprises a plurality of barbs.

7. The device of claim 1 wherein said central control means is a flexible catheter.

8. The device of claim 1 wherein said central control means is a thread.

9. A method for engrafting a prosthesis to a wall of a lumen comprising the steps of:

a) providing an access to the lumen;

b) providing a device for engrafting said prosthesis comprising;

a tubular introducer sheath having a longitudinal bore;

a tubular graft having a longitudinal bore and disposed in the longitudinal bore of said tubular introducer sheath, said graft being expandable radially to substantially conform to an interior wall of a lumen;

a self expanding spring assembly having a compressed state and attached to said tubular graft for expanding said graft so that it substantially conforms to an interior wall of a lumen when said introducer sheath has been removed from said self expanding spring assembly, said introducer sheath containing said self expanding spring assembly in said compressed state when said spring assembly is positioned in said longitudinal bore of said introducer sheath;

anchoring means for attaching said graft to an interior wall of a lumen;

tubular carrier means having a longitudinal bore and disposed in the longitudinal bore of said tubular graft, said tubular carrier means also having a plurality of apertures;

central control means for maintaining an axial position of said prosthesis during removal of said introducer sheath, said central control means being disposed in the longitudinal bore of said tubular carrier means; and

mooring loops engaging said prosthesis and passing through said apertures in said tubular carrier means to engage said central control means;

c) inserting said device into said access and urging said device to a desired location within the lumen;

d) withdrawing said tubular introducer sheath to expose said prosthesis;

e) allowing said self expanding spring assembly to self expand and substantially conform at least a portion of said graft to an interior wall of the lumen after said introducer sheath has been removed from said self expanding spring assembly;

f) disengaging said central control means from said mooring loops; and

g) removing said tubular introducer sheath, carrier means, and central control means.

10. A transluminal arrangement for positioning a prosthesis assembly at a particular position on a wall of a lumen, comprising:

an introducer sheath having a longitudinal bore therein;

a prosthesis assembly including a graft having a longitudinal bore and a self expanding spring assembly having a compressed state, said introducer sheath containing said self expanding spring assembly in said compressed state when said self expanding spring assembly is positioned in said longitudinal bore of said introducer sheath, said self expanding spring assembly radially expanding said graft to substantially conform said graft at a particular position on an interior wall of a lumen after said prosthesis assembly has been positioned in the lumen and said self expanding spring assembly has been released from said compressed state; and

means positioned in said bore of said graft for retaining said prosthesis assembly at the particular position in the lumen when withdrawing said introducer sheath from said self expanding spring assembly and releasing said self expanding spring assembly from said compressed state.

11. The transluminal arrangement of claim 10 wherein said means for retaining comprises an elongated member having a dilator head at a distal end thereof, said head serving to facilitate penetration of said arrangement within the lumen and to minimize deleterious blood flow through the lumen during positioning of said arrangement.

12. The transluminal arrangement of claim 10 further comprising means for releasing said prosthesis assembly from said means for retaining after said introducer sheath has been withdrawn from said prosthesis assembly,

18. The transluminal arrangement of claim 12, characterized in that a contraction arrangement (39, 39'"'"',21) is provided to temporarily pull said prosthesis assembly when said sheath is being withdrawn from said prosthesis assembly, and in that a disabling arrangement (26) is provided for releasing said prosthesis assembly either during or after removal of said sheath.

19. The transluminal arrangement of claim 18, characterized in that said contraction and disabling arrangements form part of said attachment arrangement, and in that part of said contraction and disabling arrangements are located and controlled within said elongated tubular member.

20. The transluminal arrangement of claim 19, characterized in that said attachment arrangement comprises at least one connector each in the form of sutures (39, 39'"'"') connected at one end to said prosthesis assembly and at the other end to inside of said elongated tube via apertures (29,101) and in that said disabling arrangement (26) is provided for releasing said sutures from inside said elongated tube.

13. A method of transluminally positioning a prosthesis assembly at a particular position on an interior wall of a lumen, comprising the steps of:

providing access to a lumen;

providing an introducer sheath having a longitudinal bore;

providing a prosthesis assembly positioned in said longitudinal bore of said introducer sheath and including a graft having a longitudinal bore and a self expanding spring assembly having a compressed state, said introducer sheath containing said self expanding spring assembly in said compressed state when said spring assembly is positioned in said longitudinal bore of said introducer sheath, said self expanding spring assembly radially expanding said graft to substantially conform said graft at a particular position on an interior wall of a lumen after said prosthesis assembly has been positioned in the lumen and said introducer sheath has been withdrawn from said prosthesis assembly releasing said self expanding spring assembly from said compressed state;

providing means positioned in said bore of said graft for retaining said prosthesis assembly at the particular position in the lumen;

positioning said introducer sheath and said prosthesis assembly positioned in said bore of said introducer sheath through said access to the particular position in the lumen; and

withdrawing said introducer sheath from said prosthesis assembly positioned at the particular position in the lumen.

14. A transluminal arrangement for positioning at a particular position on a wall of a lumen a prosthesis assembly released from an introducer sheath, said transluminal arrangement comprising:

means for retaining said prosthesis assembly at the particular position in the lumen, said prosthesis assembly including a graft having a longitudinal bore and a self expanding spring assembly having a compressed state, said means for retaining being positioned in said bore of said graft, said introducer sheath containing said self expanding spring assembly in said compressed state when said spring assembly is positioned in said introducer sheath, said self expanding spring assembly radially expanding said graft to substantially conform said graft at a particular position on an interior wall of a lumen after said prosthesis assembly has been positioned in the lumen and said self expanding spring assembly has been released from said compressed state; and

means for releasing said prosthesis assembly from said retaining means when positioned at the particular position in the lumen.

15. A transluminal arrangement for transluminally positioning a prosthesis assembly (1,12,31) of predetermined shape and size at a particular position on an internal wall (20) of a lumen, said prosthesis assembly comprising a graft (1) associated with a self expanding spring assembly (12,31) having a compressed state, said transluminal arrangement comprising an outer sheath (4) having a longitudinal bore for surrounding said prosthesis assembly when the latter is located at the particular position, and means (39,39'"'"',21, 26) for retaining said prosthesis assembly at the particular position while said outer sheath is being removed, characterized in that said retaining means has connected thereto an attachment arrangement (39,39'"'"') to be temporarily attached to said prosthesis assembly at least one position remote from a proximal end of said prosthesis assembly and in that said outer sheath maintains said self expanding spring assembly in said compressed state when said self expanding spring assembly is positioned in said longitudinal bore of said outer sheath.

16. The transluminal arrangement of claim 15, characterized in that said retaining means comprises an elongated member (21) to be extended within said prosthesis assembly, and in that said attachment arrangement is extended between said elongated member and said prosthesis assembly at said at least one position.

17. The transluminal arrangement of claim 16, characterized in that said elongated member is tubular and has a dilator head (22) at a distal end thereof, said head serving to facilitate penetration of said transluminal arrangement within the lumen and to minimize deleterious blood flow through the lumen during positioning of said prosthesis assembly.

21. The transluminal arrangement of claim 16, characterized in that said self expanding spring assembly comprises at least four barbs at a distal end of said spring assembly.

22. The transluminal arrangement of claim 16, characterized in that one end of said graft is sealed (80) to prevent flow of blood through the lumen.

23. An arrangement for transluminally positioning a prosthesis assembly at a particular position on an internal wall of a lumen, said assembly comprising a graft associated with self expanding spring apparatus having a compressed state, said arrangement comprising an outer sheath having a longitudinal bore for surrounding the said assembly when the latter is at the said particular position and for maintaining said self expanding spring apparatus in said compressed state when said self expanding spring apparatus is positioned in said longitudinal bore of said outer sheath, means for ensuring that the prosthesis assembly is maintained at the said particular position during removal of the outer sheath, said arrangement further comprising releasing means for disabling the ensuring means after the outer sheath has been withdrawn from the self expanding spring apparatus and released said self expanding spring apparatus from said compressed state and the prosthesis assembly has self expanded to the internal wall of the lumen at said particular position.

24. An arrangement for transluminally positioning a prosthesis assembly at a particular position on an internal wall of a lumen, said assembly comprising a graft associated with self expanding spring apparatus having a compressed state, said arrangement comprising an outer sheath having a longitudinal bore for surrounding the said assembly when the latter is at the said particular position, said outer sheath containing said self expanding spring apparatus in said compressed state when said spring apparatus is positioned in said longitudinal bore of said outer sheath, means for restraining axial movement of the prosthesis assembly during at least partial removal of the outer sheath, and means for disabling the restraining means after the outer sheath has been withdrawn from the self expanding spring apparatus and released said self expanding spring apparatus from said compressed state and the prosthesis assembly has self expanded to the said internal wall.