Pressure-sensitive balloon catheter

• US 5,980,485 A
• Filed: 03/13/1998
• Issued: 11/09/1999
• Est. Priority Date: 03/13/1998
• Status: Expired due to Fees

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Inventors: Grantz, Stephen M., Hudson, John
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US09/042,232
• Time in Patent Office: 606 Days
• Field of Search: 604/96, 604/97, 604/99, 604/100, 606/191, 606/192, 606/194
• US Class Current: 604/96.01
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1088 having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/10187 Indicators for the level of inflation or deflation
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A pressure-sensitive balloon catheter includes a material that undergoes a visible color change when exposed to the pressures experienced in an angioplasty or a stent placement procedure. By removing the balloon catheter and verifying the color change and the patterns of colors on the balloon, a physician can verify that proper amounts of pressure were applied to all portions of a patient'"'"'s artery or a stent within a patient'"'"'s artery.

Claims

1. A pressure-sensitive balloon catheter, comprising:

a catheter having a distal end;

a balloon mounted to the distal end of the catheter;

means for inflating the balloon; and

a pressure-sensitive material fixedly associated with the balloon, wherein the pressure-sensitive material undergoes a change in a physical characteristic when exposed to pressure to indicate the amount of pressure applied to the balloon.

2. The pressure-sensitive balloon catheter of claim 1, wherein the pressure-sensitive material comprises a pressure-sensitive film.

3. The pressure-sensitive balloon catheter of claim 2, wherein the pressure-sensitive film is mounted on an outer surface of the balloon.

4. The pressure-sensitive balloon catheter of claim 2, wherein the pressure-sensitive film is mounted on an inner surface of the balloon.

5. The pressure-sensitive balloon catheter of claim 2, wherein:

the balloon comprises a first layer and a second layer; and

the pressure-sensitive film is disposed between the first layer of the balloon and the second layer of the balloon.

6. The pressure-sensitive balloon catheter of claim 1, wherein the pressure-sensitive material comprises a pressure-sensitive coating.

7. The pressure-sensitive balloon catheter of claim 6, wherein the pressure-sensitive coating is disposed on an outer surface of the balloon.

8. The pressure-sensitive balloon catheter of claim 6, wherein the pressure-sensitive coating is disposed on an inner surface of the balloon.

9. The pressure-sensitive balloon catheter of claim 1, wherein the change in a physical characteristic is a change in color.

10. The pressure-sensitive balloon catheter of claim 9, wherein the change in color is visually perceptible.

11. The pressure-sensitive balloon catheter of claim 1, wherein the means for inflating comprises an inflation lumen in fluid communication with the balloon.

12. A pressure-sensitive balloon catheter, comprising:

a catheter having a distal end;

a pressure-sensitive balloon mounted to the distal end of the catheter, the balloon comprising dynamic, pressure-measuring indicia responsive to being subjected to a pressure above a predetermined threshold level to change a physical characteristic and thereby visually indicate the amount of pressure applied to the balloon; and

means for inflating the balloon.

13. The pressure-sensitive balloon catheter of claim 12, wherein the pressure-measuring indicia comprises:

a translucent polymeric material;

a plurality of microcapsules disposed within the polymeric material, wherein said microcapsules are adapted to rupture upon the application of pressure; and

a color developing material within the polymeric material.

14. A pressure-sensitive balloon catheter, comprising:

a catheter comprising an inflation lumen;

a balloon mounted to the catheter and in fluid communication with the inflation lumen; and

wherein the balloon comprises a pressure-sensitive material, the pressure-sensitive material including dynamic, pressure-measuring indicia, wherein the pressure-measuring indicia is responsive to the application of a pressure above the predetermined threshold level to change a physical characteristic and thereby indicate the amount of pressure applied to the pressure-sensitive material.

15. The pressure-sensitive balloon catheter of claim 14, wherein the pressure-sensitive material comprises a pressure-sensitive film.

16. The pressure-sensitive balloon catheter of claim 15, wherein the pressure-sensitive film is mounted on an outer surface of the balloon.

17. The pressure-sensitive balloon catheter of claim 15, wherein the pressure-sensitive film is mounted on an inner surface of the balloon.

18. The pressure-sensitive balloon catheter of claim 15, wherein:

the balloon comprises a first layer and a second layer; and

the pressure-sensitive film is disposed between the first layer of the balloon and the second layer of the balloon.

19. The pressure-sensitive balloon catheter of claim 14, wherein the pressure-sensitive material comprises a pressure-sensitive coating.

20. The pressure-sensitive balloon catheter of claim 19, wherein the pressure-sensitive coating is disposed on an outer surface of the balloon.

21. The pressure-sensitive balloon catheter of claim 19, wherein the pressure-sensitive coating is disposed on an inner surface of the balloon.

22. The pressure-sensitive balloon catheter of claim 14, wherein the change in a physical characteristic is a change in color.

23. The pressure-sensitive balloon catheter of claim 22, wherein the change in color is visually perceptible.

24. A pressure-sensitive balloon catheter, comprising:

a catheter having a distal end and an inflation lumen;

a balloon mounted to the distal end of the catheter, the balloon being in fluid communication with the lumen, wherein the inflation lumen is operative to inflate the balloon; and

a pressure-sensitive material mounted to the balloon, the pressure-sensitive material comprising a pressure-sensitive coating applied to the balloon, wherein the pressure-sensitive material undergoes a change in a physical characteristic when exposed to pressure.

25. The pressure-sensitive balloon catheter of claim 24, wherein the pressure-sensitive coating is disposed on an outer surface of the balloon.

26. The pressure-sensitive balloon catheter of claim 24, wherein the pressure-sensitive coating is disposed on an inner surface of the balloon.

27. A pressure-sensitive balloon catheter, comprising;

a catheter having a distal end and an inflation lumen;

a balloon mounted to the distal end of the catheter, the balloon comprising a first layer and a second layer and being in fluid communication with the lumen, wherein the inflation lumen is operative to inflate the balloon; and

a pressure-sensitive material fixedly associated with the balloon, the pressure-sensitive material comprising a pressure-sensitive film disposed on one of an inner surface of the balloon or between the inner and outer layers of the balloon, wherein the pressure-sensitive material undergoes a change in a physical characteristic when exposed to pressure.

28. The pressure-sensitive balloon catheter of claim 27, wherein the change in a physical characteristic is a change in color.

29. The pressure-sensitive balloon catheter of claim 28, wherein the change in color is visually perceptible.

30. A pressure-sensitive balloon structure for use in medical dilatation procedures, comprising:

a balloon comprising a polymeric material;

means for inflating the balloon; and

a pressure-sensitive material fixedly associated with the balloon, wherein the pressure-sensitive material under goes a change in a physical characteristic when exposed to pressure to indicate the amount of pressure applied to the balloon.

31. A pressure-sensitive balloon structure for use in medical dilatation procedures, comprising:

a balloon comprising a translucent polymeric material, a plurality of microcapsules, and a color-developing material, wherein the microcapsules are adapted to rupture upon the application of pressure to indicate the amount of pressure applied to the balloon; and

means for inflating the balloon.