Percutaneous bypass graft and securing system

• US 5,989,276 A
• Filed: 11/07/1997
• Issued: 11/23/1999
• Est. Priority Date: 11/08/1996
• Status: Expired due to Fees

• Current Assignee: Advanced Bypass Technologies, Inc.
• Original Assignee: Advanced Bypass Technologies, Inc.
• Inventors: Whayne, James G., Houser, Russell A., Fleischman, Sid D.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): HO, TAN-UYEN THI
• Application Number:
  US08/966,003
• Time in Patent Office: 746 Days
• Field of Search: 606/139, 606/194, 606/195, 606/198, 606/151, 606/153, 606/170, 623/1, 623/3, 604/53
• US Class Current: 606/170
• 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 2/0022 placed deep in the body opening occluding blood vessels by internal devices A61B17/12022
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/2424 Ball valves
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• 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. A body implantable graft, including:

a tubular graft wall having opposite first and second open ends, defining a fluid flow lumen between the first and second ends, adapted for a selected placement in body tissue with the first end at a first location in the tissue and the second end at a second location in the tissue, to provide a fluid flow path between the first and second locations to bypass an obstruction between the locations; and

a graft fixation apparatus operable to heat the body tissue at least near the first end following said placement, to thermally secure the graft wall and the tissue adjacent the first end.

2. The graft of claim 1 wherein:

the fixation apparatus further is operable to heat the body tissue near the second end, thermally securing the graft wall and the tissue adjacent the second end.

3. The graft of claim 2 wherein:

the fixation apparatus includes a first electrically conductive heating element mounted with respect to the graft wall near first end, a second electrically conductive heating element mounted with respect to the graft wall near second end, and a means for providing an electrical current to the first and second heating elements.

4. The graft of claim 3 further including:

first and second retaining features for mechanically securing the graft wall at said first and second locations, respectively.

5. The graft of claim 1 wherein:

the graft fixation apparatus includes an electrically conductive heating element mounted with respect to the graft wall near the first end.

6. The graft of claim 5 wherein:

the heating element extends substantially the full circumferential distance around the graft wall.

7. The graft of claim 6 wherein:

the heating element is an annular member incorporating a feature for mechanically securing the first end of the graft at the first location.

8. The graft of claim 1 further including:

a valve mounted to the graft wall along the fluid flow lumen for permitting fluid flow only in one direction through the lumen.

9. The graft of claim 1 further including:

at least one pocket in the graft wall.

10. The graft of claim 5 wherein:

the means for providing electrical current to the heating element includes an RF current source, a first conductor coupled between the RF current source and the heating element, an indifferent electrode spaced apart from the heating element, and a second conductor coupled to the RF current source and to the indifferent electrode, whereby the heating of the adjacent tissue is primarily ohmic.

17. A graft deploying system including the graft of claim 1 and further including:

an elongate and flexible carrier having a proximal end and a distal end, insertable by the distal end for intralumenal movement toward a selected site along a body lumen while the proximal end remains outside the body;

a tissue perforating mechanism proximate the distal end, positionable near the selected site and operable from the proximal end of the carrier to form a first opening through the body tissue at the first location, and further positionable near the selected site and operable to form a second opening through the body tissue at the second location;

an elongate graft guide, supported by the carrier, disposed near said distal end, and movable into a guiding position in which the graft guide extends from the first location through the first opening to the second location and through the second opening;

wherein said tubular graft wall is adapted to be mounted to the carrier for movement along the carrier; and

a graft controller operable to move the tubular graft wall, when so mounted, distally along the catheter toward the graft guide, and then distally along the graft guide when the guide is in the guiding position, to a by-pass location in which the graft wall extends from the first location to the second location and further extends through the first opening and the second opening.

18. The system of claim 17 wherein:

the fixation apparatus further is operable to heat the body tissue near the second end, thermally securing the graft wall and the tissue adjacent the second end.

19. The system of claim 17 wherein:

the graft fixation apparatus includes an electrically conductive heating element mounted with respect to the graft wall near the first end.

20. The system of claim 19 wherein:

the means for providing electrical current to the heating element includes an RF current source, a first conductor coupled between the RF current source and the heating element, an indifferent electrode spaced apart from the heating element, and a second conductor coupled to the RF current source and to the indifferent electrode, whereby the heating of the adjacent tissue is primarily ohmic.

11. A body implantable graft, including:

a tubular graft wall having a pocket formed therein and further having opposite first and second open ends, said graft wall defining a fluid flow lumen between the first and second ends, adapted for a selected placement in body tissue with the first end at a first location in the body tissue and the second end at a second location spaced apart from the first location, to provide a fluid flow path between the first and second locations; and

a graft fixation apparatus operable to heat the body tissue at least near the first end following said placement, to thermally secure the graft wall and the body tissue adjacent the first end.

12. The graft of claim 11 wherein:

the tubular graft wall is comprised of at least two layers of a graft material, and the pocket is formed between two adjacent layers.

13. The graft of claim 12 further including:

a biocompatible foam contained within the pocket.

16. The graft of claim 11 wherein:

said second location is in the body tissue, and the fixation apparatus further is operable to heat the body tissue near the second end, thermally securing the graft wall and the body tissue adjacent the second end.

14. The graft of claim 11wherein:

the graft fixation apparatus includes an electrically conductive heating element mounted with respect to the graft wall near the first end.

15. The graft of claim 14 wherein:

the means for providing electrical current to the heating element includes an RF current source, a first conductor coupled between the RF current source and the heating element, an indifferent electrode spaced apart from the heating element, and a second conductor coupled to the RF current source and to the indifferent electrode, whereby the heating of the adjacent tissue is primarily ohmic.

21. A body implantable graft including:

a tubular body defining a lumen and having first and second ends, adapted for placement between at least two regions of a vessel with part of the tubular body residing outside of the vessel;

at least one support structure attached to the tubular body near the first end; and

a graft fixation apparatus operable to heat the vessel at least near said first end, to thermally secure the tubular body and vessel adjacent the first end.

22. The graft of claim 21 wherein:

the fixation apparatus further is operable to heat the vessel near the second end, thermally securing the tubular body and the vessel adjacent the second end.

23. The graft of claim 21 wherein:

the support structure is adapted for assuming a delivery profile to facilitate positioning the tubular body in the vessel, and further is radially expandable from the delivery profile into contact with the vessel.

24. The graft of claim 21 wherein:

the fixation apparatus includes at least one electrically conductive heating element mounted with respect to the tubular body near the first end.

25. The graft of claim 24 wherein:

the electrically conductive heating element extends substantially the full circumferential distance around the tubular body.

26. The graft of claim 24 wherein:

the electrically conductive heating element is an annular member incorporating a feature for mechanically securing the first end of the tubular body to the vessel.

27. The graft of claim 21 further including:

at least one securing feature for mechanically securing the tubular body to the vessel at least near one of the first and second ends.

28. The graft of claim 21 wherein:

the tubular body includes at least two compliant graft layers configured to form at least one pocket.

29. A thermally securable bypass graft including:

a tubular body having one end adapted for fluid coupling to the interior of a vessel with a portion of the tubular body extending outside of the vessel;

an electrode structure attached to the tubular body;

a conductor attached to the electrode structure and adapted to transmit an electrical current to the electrode structure, to heat tissue adjacent the electrode structure and thereby thermally secure the tissue to the tubular body.

30. The graft of claim 29 wherein:

the conductor is adapted for separation from the electrode structure after said thermal securing of the tubular body and tissue.

31. The graft of claim 30 wherein:

the conductor is separable from the electrode structure responsive to conducting an electrical current of sufficient amplitude to cause a breakdown of a narrowed portion of the conductor.

32. The graft of claim 29 further including:

a support structure near the electrode structure.

33. The graft of claim 32 wherein:

said support structure is adapted for assuming a delivery profile for positioning the tubular body within the vessel, and further is radially expandable into contact with the vessel after positioning.

34. The graft of claim 29 further including:

an indifferent electrode spaced apart from the electrode structure and cooperating with the electrode structure to generate an ohmic current through the tissue.

35. The graft of claim 29 wherein:

the tubular body includes at least two compliant layers that cooperate to form at least one pocket.