Percutaneous bypass graft and securing system

• US 6,293,955 B1
• Filed: 10/08/1999
• Issued: 09/25/2001
• Est. Priority Date: 09/20/1996
• Status: Expired due to Fees

• Current Assignee: Converge Medical, Inc.
• Original Assignee: Converge Medical, Inc.
• Inventors: Whayne, James G., Houser, Russell A., Fleischman, Sid D.
• Primary Examiner(s): Recla, Henry J.
• Assistant Examiner(s): Ho, (Jackie) Tan-Uyen
• Application Number:
  US09/415,776
• Time in Patent Office: 718 Days
• Field of Search: 606/153, 606/191, 606/192, 606/194, 606/198, 606/151, 606/152, 623/1.11, 623/1.12, 623/1.36
• US Class Current: 606/153
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/34 Trocars; Puncturing needles pointed biopsy instruments A61B10/0233; devices for piercing the ear-lobes A44C7/001; seals or hemostasis valves A61M39/06
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61F 2/0009 placed in or outside the body opening close to the surface of the body plugging an opening in the wall of a hollow or tubular organ A61B17/0057
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2424 Ball valves
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2210/0033 electrically, e.g. heated by resistor
• CPC Class Codes: A61F 2210/0085 hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A bypass graft incorporates fixation mechanisms at its opposite ends, for securing these ends to different locations along a blood vessel, or alternatively to different locations wherein one of the locations is a different vessel or an organ defining a cavity. Mechanical fixation features such as collets or grommets can be employed, enhanced by delivery of an electrical current sufficient to heat surrounding tissue to form a thermal bond. A graft deployment system includes a tissue dilator and a needle for perforating tissue, mounted coaxially within the dilator. Intralumenal systems further include a catheter for containing the dilator.

Claims

1. An anastomotic connector system for connecting a tubular graft to a blood vessel or hollow body organ comprising:

a collet comprising a tubular collet portion having a proximal end and a distal end, and a plurality of radially self-expanding collet members separate from each other and disposed around the distal end of the tubular collet portion and depending therefrom,

each of the collet members having a proximal end and a distal end, the distal end of each collet member having a blunt configuration so as to extend along a vessel or body organ wall interior.

2. The connector system of claim 1 additionally comprising a tubular graft joined to the collet.

3. The connector system of claim 2 wherein the graft is laminated to the collet.

4. The connector system of claim 2 wherein the graft is bonded to the collet.

5. The connector system of claim 2 wherein the graft is joined to the collet over an outer surface of the collet tubular portion proximal end, overlapping a vessel or organ wall.

6. The connector system of claim 1 wherein the collet comprises a memory elastic material.

7. The connector system of claim 1 wherein the collet comprises a material selected from the group consisting of stainless steel, nickel titanium and thermoset plastic.

8. The connector system of claims 1 wherein the self-expanding collet members comprise a memory elastic material.

9. The connector system of claim 1 wherein the self-expanding collet members comprise a material selected from the group consisting of stainless steel, nickel titanium and thermoset plastic.

10. The connector system of claim 1 wherein the collet is capable of expanding into an expanded profile from a collapsed first profile.

11. The connector system of claim 1 wherein the self-expanding collet members are configured to self-expand from a first confined position substantially colinear to the tubular collet portion to a second unconfined position extending radially outward upon release from the first confined position.

12. The connector system of claim 11 wherein the self-expanding collet members form an angle with the tubular collet portion of between about 45 degrees and 120 degrees when in the second unconfined position.

13. The connector system of claim 12 wherein the angle is about 90 degrees.

14. The connector system of claim 1 wherein the self-expanding collet members are adapted to attach a graft to a vessel or organ wall interor by direct contact between the self-expanding collet member and the vessel or organ wall interior without penetrating the vessel or organ wall interior.

15. The connector of claim 14 wherein the at least one collet member is configured to bow outward to exert force against a vessel or organ wall and support a graft within a lumen defined by the vessel or organ wall.

16. The connector system of claim 1 additionally comprising a membrane disposed about at least a portion of the collet members.

17. The connector system of claim 16 wherein the membrane is at least partially impervious to fluid flow therethrough.

18. The connector system of claim 1 additionally comprising a membrane forming a substantially fluid-impervious layer disposed about at least a portion of the collet members such that when said connector is deployed at a vessel or organ puncture site, said membrane substantially prevents fluid flow through the puncture site.

19. The connector system of claim 18 wherein the covering forms a continuous, annular, fluid-impervious layer.

20. The connector of claim 1 wherein said collet members comprise segments extending from said tubular collet portion.