Catheter balloon with ultrasonic microscalpel blades

• US 20030229370A1
• Filed: 06/11/2002
• Published: 12/11/2003
• Est. Priority Date: 06/11/2002
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Miller, Paul James
• Granted Patent: US 7,153,315 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• CPC Class Codes: A61B 17/2202 the ultrasound transducer being inside patient's body at the distal end of the catheter
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2018/0022 Balloons

Abstract

The present invention provides a catheter balloon, and balloon catheter incorporating the catheter balloon, useful in medical dilation procedures. The catheter balloon includes at least one microscalpel operatively disposed on an outer surface thereof. The microscalpel may advantageously be operatively disposed relative to a power source so as to be controllably activatable. Also provided are methods of making the inventive balloon and/or catheter as well as methods of using the inventive catheter in a dilation/incising treatment.

Claims

1. A cutting dilation balloon comprising:

a balloon body having an outer surface; and

at least one microscalpel operatively disposed relative to the outer surface of the body.

2. The cutting dilation balloon of claim 1, wherein the microscalpel comprises a crystalline material.

3. The cutting dilation balloon of claim 2, wherein the crystalline material comprises a monocrystalline material.

4. The cutting dilation balloon of claim 3, wherein the monocrystalline material is silicon.

5. The cutting dilation balloon of claim 1, wherein the microscalpel has a radius of curvature of between about 0.5 nm and about 100 nm.

6. The cutting dilation balloon of claim 1, wherein the microscalpel has a radius of curvature between about 1 nm and about 50 nm.

7. The cutting dilation balloon of claim 1, wherein at least a portion of the microscalpel includes a thin-film coating.

8. The cutting dilation balloon of claim 7, wherein the thin-film coating comprises silicon dioxide, silicon nitride, titanium diboride, diamond like carbon, silicon carbide or combinations thereof.

9. The cutting dilation balloon of claim 7, wherein at least one microscalpel is operatively disposed relative to a source of power so as to be controllably activatable.

10. The cutting dilation balloon of claim 9, wherein the power source is capable of being controlled so as to controllably activate, deactivate, pulse, or otherwise vary the power supplied to the microscalpel.

11. The cutting dilation balloon of claim 9, wherein the power source provides oscillatory, thermal, RF, electric energy, or a combination of these, to the microscalpel.

12. The cutting dilation balloon of claim 11, wherein the power source is a source of ultrasonic energy.

13. The cutting dilation balloon of claim 12, wherein the microscalpel is ultrasonically activatable by the provision of a transducer operatively disposed relative to the microscalpel.

14. The cutting dilation balloon of claim 13, wherein the transducer is a thin-film transducer formed on at least a portion of a surface of the microscalpel.

15. The cutting dilation balloon of claim 14, wherein the thin-film transducer includes at least one piezoelectric material.

16. The cutting dilation balloon of claim 13, wherein the transducer oscillates at a frequency in the range from about 1 kHz to about 300 kHz.

17. The cutting dilatation balloon of claim 13, wherein the transducer oscillates at a frequency in the range from about 20 kHz to about 80 kHz.

18. A cutting balloon catheter comprising:

an elongated catheter shaft having a proximal end, a distal end, and an inflation lumen extending through at least a section thereof; and

a cutting dilation balloon comprising

a balloon body having an outer surface and an interior in fluid communication with the inflation lumen; and

at least one microscalpel operatively disposed relative to the outer surface of the body.

19. The cutting balloon catheter of claim 18, wherein at least one microscalpel is operatively disposed relative to a source of power so as to be controllably activatable.

20. The cutting balloon catheter of claim 19, wherein the power source is capable of being controlled so as to controllably activate, deactivate, pulse, or otherwise vary the power supplied to the microscalpel.

21. The cutting balloon catheter of claim 19, wherein the power source provides oscillatory, thermal, RF, electric energy, or a combination of these, to the microscalpel.

22. The cutting balloon catheter of claim 21, wherein the power source is a source of ultrasonic energy.

23. A method of forming a cutting balloon comprising the steps of:

providing a balloon having an outer surface;

providing at least one microscalpel; and

mounting the at least one microscalpel onto the outer surface of the balloon.

24. The method of claim 23, wherein the microscalpel is ultrasonically activatable.

25. A method of forming a cutting balloon catheter comprising the steps of:

providing a balloon having an outer surface, an interior, and at least one microscalpel operatively disposed on the outer surface;

providing an elongated catheter shaft having a proximal end, a distal end and an inflation lumen extending through at least a portion thereof; and

mounting the balloon on the catheter shaft so that the interior of the balloon is in fluid communication with the inflation lumen.

26. The method of claim 25, wherein the microscalpel is ultrasonically activatable.

27. A method for incising a stenosis comprising the steps of:

providing a balloon catheter, comprising;

an elongated catheter shaft having an inflation lumen extending through at least a portion thereof;

a balloon having an interior, an outer surface, and at least one microscalpel operatively disposed on the outer surface, wherein the interior of the balloon is in fluid communication with the inflation lumen;

inserting the balloon catheter into the bodily lumen and directing the balloon to the site to be dilated; and

inflating the balloon so that at least one microscalpel at least partially incises the stenosis.

28. The method of claim 27, wherein at least one microscalpel is operatively disposed relative to a source of power so as to be controllably activatable.

29. The method of claim 28, wherein the power source is capable of being controlled so as to controllably activate, deactivate, pulse, or otherwise vary the power supplied to the microscalpel.

30. The method of claim 29, wherein the power source provides oscillatory, thermal, RF, electric energy, or a combination of these, to the microscalpel.

31. The method of claim 30, wherein the power source is a source of ultrasonic energy.

32. The method of claim 31 wherein the microscalpel is activated with ultrasonic energy for at least a portion of the time that the balloon is inflated.