Balloon catheters and methods for use

• US 9,034,025 B2
• Filed: 08/31/2012
• Issued: 05/19/2015
• Est. Priority Date: 05/23/2005
• Status: Active Grant

• Current Assignee: Ostial Corporation
• Original Assignee: Ostial Corporation
• Inventors: Sanati, Archimedes, Khosravi, Farhad
• Primary Examiner(s): EASTWOOD, DAVID C
• Application Number:
  US13/602,074
• Publication Number:
  US 20130060316A1
• Time in Patent Office: 991 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.35, 606191-200, 604/101.01, 604/101.02, 604/103.07, 60410311-10313, 604/916
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• 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 2002/30322 differing in surface structures
• CPC Class Codes: A61F 2002/821 Ostial stents
• CPC Class Codes: A61F 2230/0071 spherical
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0026 differing in surface structures
• CPC Class Codes: A61F 2250/0039 differing in diameter
• 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

Abstract

Apparatus and methods are provided for flaring a stent deployed within a branch vessel including an ostium communicating with a main vessel, a first end of the stent extending at least partially from the branch. A catheter is provided that includes a first balloon carried on its distal end, and a second balloon that includes a distal section overlying at least a portion of the first balloon and a proximal section. The catheter distal end is introduced into the main vessel and positioned through the ostium and stent into the branch until the first balloon is disposed within the stent. The first balloon is expanded to anchor the stent, and the second balloon is expanded to flare the first end of the stent. Optionally, the first balloon is expanded further, e.g., to expand the stent within the branch body lumen and/or dilate the lesion.

Claims

1. A method for flaring a stent previously deployed within a branch body lumen including an ostium communicating with a main body lumen, a first end of the stent extending at least partially from the branch body lumen into the ostium, the method comprising:

providing an elongate member including a proximal end, a distal end, a first balloon carried on the distal end that includes a substantially uniform diameter main section when expanded, and a second balloon carried on the distal end that includes a distal section overlying at least a portion of the uniform diameter section of the first balloon and a proximal section extending proximally from the distal section and the first balloon, wherein the second balloon is formed from compliant material molded to a shape in which the proximal section has a bulbous shape defining a first diameter and the distal section has a substantially cylindrical shape defining a second diameter smaller than the first diameter;

introducing the distal end into the main body lumen;

positioning the distal end of the elongate member through the ostium and stent into the branch body lumen until the main section is disposed within the stent;

expanding the first balloon to substantially anchor the stent axially relative to the branch body lumen; and

expanding the proximal section of the second balloon to flare the first end of the stent within the ostium.

2. The method of claim 1, further comprising, after expanding the proximal section of the second balloon, further expanding the first balloon to expand the stent within the branch body lumen.

3. The method of claim 2, wherein the diameter of the branch body lumen does not increase substantially when the first balloon is initially expanded, and wherein the branch body lumen is dilated when the first balloon is further expanded to expand the stent.

4. The method of claim 1, wherein positioning the distal end of the elongate member comprises positioning the distal end of the elongate member such that the proximal section of the second balloon is disposed adjacent the ostium before initially expanding the first balloon.

5. The method of claim 4, further comprising monitoring markers on the distal end of the elongate member to facilitate positioning the proximal section of the second balloon adjacent the ostium.

6. The method of claim 1, wherein initially expanding the first balloon prevents the stent from migrating substantially when the proximal section of the second balloon is expanded.

7. The method of claim 1, wherein the material of the second balloon has a thinner wall thickness along the proximal section than along the distal section.

8. The method of claim 1, further comprising delivering energy from one or more elements on at least one of the first and second balloons to surrounding tissue adjacent the stent.

26. The method of claim 1, wherein a proximal end of the first balloon is attached to the tubular member distal end at a first location, and wherein the proximal section of the second balloon extends proximally beyond the first location.

9. A method for treating a lesion within a branch body lumen including an ostium communicating with a main body lumen, the method comprising:

introducing a distal end of a delivery catheter into the main body lumen, the delivery catheter distal end carrying a stem in a contracted condition;

positioning the delivery catheter distal end within the branch body lumen such that a first end of the stem is disposed adjacent the ostium and a second end of the stem is disposed further within the branch body lumen;

expanding the stem such that the stem engages surrounding tissue of the branch body lumen;

removing the delivery catheter from the branch body lumen and main body lumen;

introducing a distal end of a flaring catheter into the main body lumen, the flaring catheter comprising a proximal end, a distal end, a first balloon carried on the flaring catheter distal end that includes a substantially uniform diameter main section when expanded, and a second balloon carried on the flaring catheter distal end that includes a distal section overlying at least a portion of the uniform diameter section of the first balloon and a proximal section extending proximally from the distal section and the first balloon;

wherein the second balloon is formed from compliant material molded to a shape in which the proximal section has a bulbous shape defining a first diameter and the distal section has a substantially cylindrical shape defining a second diameter smaller than the first diameter;

positioning the flaring catheter distal end through the ostium and stent into the branch body lumen until the main section of the first balloon is disposed within the stent;

expanding the first balloon to substantially anchor the stent axially relative to the branch body lumen; and

thereafter, expanding the proximal section of the second balloon to flare the first end of the stent within the ostium.

10. The method of claim 9, wherein the lesion is dilated when the stent is initially expanded on the delivery catheter to a substantially uniform diameter.

11. The method of claim 10, further comprising, after expanding the proximal section of the second balloon, further expanding the first balloon to expand the stent further within the branch body lumen and dilate the lesion further.

12. The method of claim 9, further comprising, after expanding the proximal section of the second balloon, further expanding the first balloon to expand the stent within the branch body lumen.

13. The method of claim 12, wherein the diameter of the branch body lumen does not change when the first balloon is initially expanded, and wherein the branch body lumen is dilated when the first balloon is further expanded to expand the stent.

14. The method of claim 9, further comprising introducing a distal end of a guidewire into the main body lumen and through the ostium into the branch body lumen, and wherein the delivery catheter distal end is introduced into the main body lumen and positioned within the branch body lumen over the guidewire.

15. The method of claim 14, wherein the flaring catheter distal end is introduced into the main body lumen over the guidewire after removing the delivery catheter.

16. The method of claim 9, wherein positioning the distal end of the flaring catheter comprises positioning the flaring catheter distal end such that the proximal section of the second balloon is disposed adjacent the ostium before initially expanding the first balloon.

17. The method of claim 16, further comprising monitoring markers on the flaring catheter distal end to facilitate positioning the proximal section of the second balloon adjacent the ostium.

18. The method of claim 9, wherein initially expanding the first balloon prevents the stent from migrating substantially when the proximal section of the second balloon is expanded.

25. The method of claim 9, further comprising delivering energy from one or more elements on at least one of the first and second balloons to surrounding tissue adjacent the stent.

27. The method of claim 9, wherein the proximal section has a thinner wall thickness than a wall thickness of the distal section.

19. A method for expanding a stent previously deployed within a body lumen, comprising:

providing an elongate member including a proximal end, a distal end, a first balloon carried on the distal end that includes a substantially uniform diameter main section when expanded, and a second balloon carried on the distal end that includes a distal section overlying at least a portion of the uniform diameter section of the first balloon and a proximal section extending proximally from the distal section and the first balloon;

positioning the distal end of the elongate member within the body lumen until the main section is disposed within the stent;

expanding the proximal section of the second balloon to substantially anchor the distal end relative to the stent; and

after expanding the proximal section, expanding the main section of the first balloon to expand the stent.

20. The method of claim 19, wherein the body lumen comprises a non-bifurcated body lumen.

21. The method of claim 19, wherein the body lumen comprises a branch body lumen including an ostium communicating with a main body lumen, wherein the stent is deployed within the branch body lumen, and wherein positioning the distal end of the elongate member comprises positioning the distal end of the elongate member through the ostium and stent into the branch body lumen until the main section is disposed within the stent.

22. A method for treating a stenosis within a body lumen, comprising:

providing an elongate member including a proximal end, a distal end, a first balloon carried on the distal end that includes a substantially uniform diameter main section when expanded, and a second balloon carried on the distal end that includes a distal section overlying at least a portion of the uniform diameter section of the first balloon and a proximal section extending proximally from the distal section and the first balloon, wherein the second balloon is formed from compliant material molded to a shape in which the proximal section has a bulbous shape defining a first diameter and the distal section has a substantially cylindrical shape defining a second diameter smaller than the first diameter;

positioning the distal end of the elongate member within the body lumen with the first and second balloons collapsed until the main section is disposed within the stenosis;

expanding the proximal section of the second balloon to substantially anchor the distal end relative to the stenosis; and

after expanding the proximal section, expanding the main section of the first balloon to dilate the stenosis.

23. The method of claim 22, wherein the body lumen comprises a non-bifurcated body lumen.

24. The method of claim 22, wherein the body lumen comprises a branch body lumen including an ostium communicating with a main body lumen and having the stenosis therein, and wherein positioning the distal end of the elongate member comprises positioning the distal end of the elongate member through the ostium and stenosis into the branch body lumen until the main section is disposed within the stenosis.