Means method for treatment of stenosed arterial bifurcations

• US 5,749,825 A
• Filed: 09/18/1996
• Issued: 05/12/1998
• Est. Priority Date: 09/18/1996
• Status: Expired due to Fees

• Current Assignee: Isostent, Inc. (Cardinal Health, Inc.), Cathco, Inc.
• Original Assignee: Isostent, Inc. (Cardinal Health, Inc.)
• Inventors: Turnland, Todd H., Fischell, David R., Fischell, Robert E., Fischell, Tim A.
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US08/714,315
• Time in Patent Office: 601 Days
• Field of Search: 600/1-8, 623/1, 623/12, 606/191-92, 606/194-95, 606/197-98
• US Class Current: 600/3
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2210/0095 radioactive
• CPC Class Codes: A61F 2250/006 modular

Abstract

A stent delivery catheter system for the treatment of stenoses at an arterial bifurcation consists of a main guide wire, a side branch guide wire, a unique design balloon angioplasty catheter which includes a side branch tube and a stent that can be deployed to a larger diameter in the main artery leading to the arterial bifurcation, and deployed to a smaller diameter within one of the branch arteries at an arterial bifurcation. The balloon angioplasty catheter used to deploy the dual diameter stent has a proximal section that has a larger diameter as compared to the diameter of a distal section which distal section is designed to be placed in a branch artery of the bifurcation. An opening in the wall of the stent allows for the passage of the side branch tube that provides angular orientation of the pre-deployed stent relative to the two branches of the bifurcation. The side branch tube is also used to help assure proper longitudinal placement of the stent relative to the saddle point of the bifurcation. After the stent is deployed, the opening in the stent wall allows unobstructed blood flow into that side branch artery that is not initially stented.

Claims

1. A stent delivery catheter system including a stent for insertion at an arterial bifurcation or arterial side branch, the system comprising:

a first guide wire adapted to be inserted through a main artery and into a continuation artery of that main artery;

a second guide wire adapted to be inserted through the main artery and into a side branch artery of the main artery, the side branch artery and the continuation of the main artery forming an arterial bifurcation therebetween;

a balloon angioplasty catheter having an inner shaft which has a distal end and also an inflatable balloon located at a distal section of the balloon angioplasty catheter, the inflatable balloon having a proximal end and a distal end, the distal end of the balloon being sealingly joined to the distal end of the inner shaft, the inner shaft being adapted to be slidingly advanced over the first guide wire;

a side branch tube being joined to the balloon near the balloon'"'"'s proximal end and also being joined to the balloon at a central attachment point which is near the longitudinal center of the balloon from which central attachment point the side branch tube extends for a length of greater than 1 mm in a distal direction free from attachment to the balloon, the side branch tube having a proximal portion and a distal portion and being adapted to be slidingly advanced over the second guide wire, and,

an expandable stent having a proximal portion and a distal portion and having an open space therebetween through which open space the side branch tube projects in a distal direction, the proximal portion of the side branch tube lying within the proximal portion of the stent and the distal portion of the side branch tube lying outside the distal portion of the stent.

2. The stent delivery catheter system of claim 1 wherein the balloon when expanded has a uniform outer diameter.

3. The stent delivery catheter system of claim 1 wherein the balloon when expanded has a proximal portion that has a first and larger diameter and a distal portion which has a second and smaller diameter.

4. The stent delivery catheter system of claim 1 wherein the side branch tube extends for a length of at least 10 mm beyond the central attachment point of the balloon to the side branch tube.

5. The stent delivery catheter system of claim 1 wherein the side branch tube lies entirely outside of the outer surface of the balloon.

6. The stent delivery catheter system of claim 1 wherein some length of the side branch tube lies within the balloon.

7. The stent delivery catheter system of claim 1 wherein the side branch tube includes a thin-walled, flexible metal tube adapted to slide over the side branch guide wire, the metal tube retaining a generally circular lumen after the stent is crimped onto the balloon.

8. The stent delivery catheter system of claim 1 wherein the balloon angioplasty catheter has a proximal end and is the "over-the-wire" design which has the first guide wire exit the balloon angioplasty catheter at the balloon angioplasty catheter'"'"'s proximal end.

9. The stent delivery catheter system of claim 1 wherein the balloon angioplasty catheter is of a "rapid exchange" design that has the first guide wire exit from the balloon angioplasty catheter within a region that is within 30 cm in a proximal direction from the proximal end of the balloon of the balloon angioplasty catheter.

10. The stent delivery catheter system of claim 1 wherein the opening between the stent'"'"'s proximal portion and the stent'"'"'s distal portion has a length in the longitudinal direction of at least 1.0 mm.

11. The stent delivery catheter system of claim 1 wherein the stent'"'"'s proximal portion and distal portion are mechanically joined together by means of one or more stent joining sections.

12. The stent delivery catheter system of claim 1 wherein the stent'"'"'s proximal portion is separate and distinct from and is free from any metal joining section attachment to the stent'"'"'s distal portion thereby forming two separate stents.

13. The stent delivery catheter system of claim 1 wherein the stent is radioactive.

14. The stent delivery catheter system of claim 13 wherein the radioactive stent emits more energy from beta particles as compared to alpha or gamma emission.

15. The stent delivery catheter system of claim 14 wherein the source of the beta-particles is the radioisotope phosphorous-32.

16. A method for the treatment of one or more stenoses located at an arterial bifurcation, the method comprising the following steps:

(a) placing a main guide wire which has a proximal end though a main artery and into a main artery continuation;

(b) placing a side branch guide wire which has a proximal end through the main artery and into a side branch artery which side branch artery and main artery continuation form a bifurcation of the main artery, the point at which the main artery is joined to the side branch artery being a saddle point;

(c) placing the proximal end of the main guide wire through the distal end of an inner shaft of a balloon angioplasty catheter which includes a balloon located at a distal section of the balloon angioplasty catheter;

(d) placing the proximal end of the side branch guide wire through the distal end of a side branch tube which side branch tube emanates in a distal direction from the balloon of the balloon angioplasty catheter at a crotch point which is a longitudinally centrally located point of the balloon;

(e) advancing the balloon angioplasty catheter including the side branch tube until the crotch point is situated at the saddle point of the arterial bifurcation;

(f) inflating the balloon of the balloon angioplasty catheter so that a stent mounted onto the exterior surface of the balloon is forced radially outward against the interior surfaces of the main artery and the main artery continuation;

(g) deflating the balloon of the balloon angioplasty catheter;

(h) removing the balloon catheter from the patient'"'"'s body.

17. The method of claim 16 including the steps of advancing another balloon angioplasty catheter over the main guide wire and inflating a balloon within that portion of the stent that has been placed in the main artery so as to further expand that portion of the stent.

18. The method of claim 16 including the steps of removing the main guide wire from the patient'"'"'s body and advancing a second balloon angioplasty catheter with a second stent mounted onto the balloon of the second balloon angioplasty catheter over the side branch guide wire and then inflating the balloon of the second balloon angioplasty catheter so as to deploy the second stent against the interior surfaces of the side branch artery and then deflating the balloon and then removing the second balloon angioplasty catheter and the side branch guide wire from the patient'"'"'s body.

19. The method of claim 16 including the steps of removing the main guide wire and the side branch guide wire.