Catheter balloon systems and methods

• US 20050015108A1
• Filed: 04/29/2004
• Published: 01/20/2005
• Est. Priority Date: 07/18/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Advanced Stent Technologies Inc. (Boston Scientific Corporation)
• Inventors: Mirzaee, Daryush, Williams, Eric, Khenansho, Michael, Schwartz, Michael
• Granted Patent: US 7,655,030 B2
• Time in Patent Office: Days
• US Class Current: 606/194
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• 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 2002/821 Ostial stents
• CPC Class Codes: A61M 2025/1045 for treating bifurcations, e.g. balloons in y-configuration, separate balloons or special features of the catheter for treating bifurcations
• CPC Class Codes: A61M 2025/1056 having guide wire lumens outside the main shaft, i.e. the guide wire lumen is within or on the surface of the balloon
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: A61P 35/00 Antineoplastic agents

Abstract

An apparatus for treatment of a bifurcation of a body lumen, the bifurcation having a main vessel and a branch vessel, the apparatus includes a bifurcated balloon with a first branch portion and a second branch portion, the second branch portion including an inflatable portion adapted to extend toward the branch vessel, the bifurcated balloon also having a proximal shaft portion and a distal shaft portion connected to the inflatable portion of the second branch portion, and wherein the first branch portion and the second branch portion each have a longitudinal axis, the axis of the first branch portion being substantially parallel to the longitudinal axis of the second branch portion.

Claims

1. An apparatus for treatment of a bifurcation of a body lumen, the bifurcation comprising a main vessel and a branch vessel, the apparatus comprising:

a bifurcated balloon comprising a first branch portion and a second branch portion;

the second branch portion comprising an inflatable portion adapted to extend toward the branch vessel, the bifurcated balloon further comprising a proximal shaft portion and a distal shaft portion connected to the inflatable portion of the second branch portion;

wherein the first branch portion and the second branch portion each have a longitudinal axis, the longitudinal axis of the first branch portion is substantially parallel to the longitudinal axis of the second branch portion.

2. The apparatus of claim 1, wherein the inflatable portion of the second branch portion is generally spherical.

3. The apparatus of claim 1, wherein the inflatable portion of the second branch portion is generally elliptical and comprises a major and minor axis.

4. The apparatus of claim 1, wherein the inflatable portion of the second branch portion is generally in the form of an offset bulbous shape.

5. The apparatus of claim 1, wherein the inflatable portion of the second branch portion is generally in the form of an offset elliptical cylinder.

6. The apparatus of claim 1, wherein the inflatable portion of the second branch portion is generally in the form of an offset cylinder.

7. The apparatus of claim 1, wherein the second branch comprises a plurality of inflatable portions.

8. The apparatus of claim 7, wherein said plurality comprises more than two inflatable portions.

9. The apparatus of claim 8, wherein the inflatable portions are circumferentially spaced about the first branch portion.

10. The apparatus of claim 8, wherein the inflatable portions are longitudinally spaced along the first branch portion.

11. The apparatus of claim 1, wherein the first and second branches share a common inflation lumen.

12. A system for treatment of a bifurcated body lumen, the system comprising:

a catheter for insertion into said body lumen, the catheter having a bifurcated distal end comprising first and second branches; and

a bifurcated balloon positioned on one of said first and second branches;

the bifurcated balloon having a first balloon branch and a second balloon branch, the first balloon branch including a first inflatable portion and the second balloon branch including a second inflatable portion, and

wherein the first inflatable portion has a generally cylindrical shape when inflated and the second inflatable portion has a generally offset bulbous shape when inflated.

13. The system of claim 12, further comprising:

a stent mounted on the bifurcated balloon, the stent including a side branch access hole.

14. The system of claim 13, wherein the stent includes an extendible branch portion configured and dimensioned to extend into a branch vessel upon expansion of the stent.

15. A method of treating a bifurcation of a body lumen, the bifurcation comprising a main vessel and a branch vessel, the method comprising:

(i) introducing a bifurcated balloon and stent assembly into the main vessel, the bifurcated balloon comprising at least one inflatable portion;

(ii) positioning the assembly at the bifurcation;

(iii) inflating the bifurcated balloon thereby expanding the inflatable portion and deploying the stent in the main vessel and outwardly toward the branch vessel.

16. The method of claims 15, wherein the bifurcated balloon comprises a first branch and a second branch, the at least one inflatable portion being disposed on the second branch of the bifurcated balloon.

17. A balloon catheter, comprising:

a catheter having a distal end, a proximal end and an inflation lumen;

a balloon formed on the distal end of the catheter, the balloon being in fluid communication with the inflation lumen and being capable of being expanded from an unexpanded configuration to an expanded configuration, wherein the balloon is generally cylindrical in the unexpanded configuration and has a herniation in the expanded configuration.

18. A herniated balloon catheter, comprising:

a balloon constructed from a composite material and including a woven material formed with a herniation, wherein the balloon has a herniation in the expanded condition.

19. The herniated balloon catheter according to claim 18, wherein the herniation is formed by balloon material.

20. The herniated balloon according to claim 18, wherein the herniation is formed by adhesive attached to the balloon.

21. A stent delivery system, comprising:

a catheter having a balloon with a herniation; and

a stent having a side opening including an outwardly expandable portion, the stent being disposed on the balloon with the stent side opening aligned with the herniation, whereby upon expansion of the balloon the herniation expands causing the outwardly expandable portion of the stent to extend toward a branch vessel.

22. A method for treating a bifurcated blood vessel, the method comprising:

introducing into the blood vessel a catheter having a distal end, a proximal end, a guide wire lumen that is adapted to receive a guide wire, and a balloon having a distal end and a proximal end, the balloon being disposed near the distal end of the catheter, the balloon having a protrusion at a location between the distal end and proximal end of the balloon, and a stent having a side opening through a wall thereof, the stent being disposed over the balloon, wherein the protrusion of the balloon is positioned adjacent the side opening;

positioning the catheter at a bifurcation by aligning the stent side opening with a side branch blood vessel; and

expanding the balloon so as to deploy the stent such that the side opening of the stent is aligned with the opening of the bifurcated vessel.

23. The method according to claim 22, wherein the stent further comprises an outwardly expandable portion disposed around any portion of the side opening wherein the expanding balloon deploys the outwardly expandable portion of the stent toward a side branch blood vessel.

24. A system for treatment of a bifurcation of a body lumen, the birfucation comprising a main vessel and a branch vessel, the system comprising:

a catheter for insertion into said body lumen, the catheter having a distal end, a proximal end, and an inflation lumen;

a balloon in fluid communication with the inflation lumen, the balloon having a first branch and a second branch, the second branch comprising an inflatable portion having a generally bulbous shape adapted to extend toward the branch vessel upon inflation; and

a stent disposed on the balloon, the stent having an opening including an outwardly expandable portion, the opening aligned with the inflatable portion, whereby expansion of the inflatable portion causes the outwardly expandable portion to extend toward the branch vessel.

25. The system of claim 24, wherein the first branch and the second branch each have a longitudinal axis, the longitudinal axis of the first branch portion being substantially parallel to the longitudinal axis of the second branch portion.

26. The system of claim 24, wherein the inflatable portion is generally in the form of an elliptical cylinder.

27. The system of claim 24, wherein the inflatable portion is generally in the form of an offset cylinder.

28. The system of claim 24, wherein the inflatable portion inflatable portion is generally in the form of an offset bulbous portion.

29. The system of claim 24, wherein the second branch portion comprises a plurality of inflatable portions.