ELECTRICALLY-INDUCED FLUID FILLED BALLOON CATHETER

• US 20160184570A1
• Filed: 12/30/2015
• Published: 06/30/2016
• Est. Priority Date: 12/30/2014
• Status: Active Grant

• Current Assignee: Spectranetics Corporation (Koninklijke Philips N.V.)
• Original Assignee: Spectranetics Corporation (Koninklijke Philips N.V.)
• Inventors: Grace, Kenneth P., Triffo, Thomas, Cezo, James
• Granted Patent: US 10,850,078 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/22022 using electric discharge
• CPC Class Codes: A61B 2017/22007 Cavitation or pseudocavitation, i.e. creation of gas bubbles generating a secondary shock wave when collapsing
• CPC Class Codes: A61B 2017/22021 electric leads passing through the catheter
• CPC Class Codes: A61B 2017/22024 with a part reflecting mechanical vibrations, e.g. for focusing
• CPC Class Codes: A61B 2017/22025 applying a shock wave A61B2017/22091 takes precedence
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 2205/054 with electrotherapy
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis

Abstract

The present disclosure relates generally to the use of medical devices for the treatment of vascular conditions. In particular, the present disclosure provides devices and methods for using electrically-induced pressure waves to disrupt vascular blockages. The present disclosure not only provides devices and methods for using electrically-induced pressure waves to disrupt vascular blockages, but the present disclosure also provides devices and method for assisting the guidewire in penetrating an occlusion, devices and method for using a sealable valve in the tip of the balloon catheter to reduce the overall size and diameter of the balloon catheter, thereby allowing the balloon catheter to penetrate smaller size blood vessels and devices. Given the persistence of coronary artery disease (CAD) and peripheral artery disease (PAD), there remains a need for improved therapeutic methods designed not only to reduce vascular blockages in the short term, but also to prevent future complications such as restenosis.

Claims

1-17. -17. (canceled)

18. A catheter comprising:

a sheath having a guidewire lumen, an inflation lumen, a proximal end and a distal end;

at least one electrode assembly adjacent to the guidewire lumen, wherein the at least one electrode assembly is coupled to an electrical generator and produces an electrical pulse;

a balloon assembly circumferentially arranged around a portion of the sheath and around at least one electrode assembly;

one or more liquid medium ports disposed within the sheath and within the balloon assembly; and

a pressure-wave reflective element disposed adjacent the balloon assembly, wherein the pressure-wave reflective element attenuates the pressure wave passing therethrough upon creation of the pressure wave within the balloon assembly by the reaction between the electrical pulse produced by the electrode assembly and a liquid medium introduced into the balloon assembly via the one or more liquid medium ports.

19. The catheter of claim 18, wherein the pressure-wave reflective element is integrally disposed within the balloon assembly.

20. The catheter of claim 18, wherein the balloon assembly has an exterior, and wherein the pressure-wave reflective element is disposed on the exterior of the balloon assembly.

21. The catheter of claim 18, wherein the balloon assembly has an interior, and wherein the pressure-wave reflective element is disposed on the interior of the balloon assembly.

22. The catheter of claim 18, wherein the pressure-wave reflective element comprises a plurality of openings.

23. The catheter of claim 22, wherein the plurality of openings are between 100 and 900 microns.

24. The catheter of claim 22, wherein a percentage of the openings within an area of a portion of the pressure-wave reflective element is between 10 percent and 90 percent.

25. The catheter of claim 22, wherein an area of the pressure-wave reflective element comprises the openings and a structural mass, wherein a ratio of the openings to the structural mass within the area is between 1:

1 and 1;

10.

26. The catheter of claim 22, wherein the plurality of openings comprise at least one of the following shapes:

circle;

oval;

triangle;

square;

rectangle;

polygon;

diamond;

pentagon;

hexagon;

heptagon;

octagon;

nonagon; and

decagon.

27. The catheter of claim 18, wherein the liquid medium is contrast medium or contrast solution.

28. The catheter of claim 27, wherein the liquid medium is any one of iodine-containing contrast medium or gadolinium contrast medium.

29. A method for treating an obstruction within vasculature of a subject, the method comprising:

positioning a catheter within vasculature of a subject, the catheter comprising;

a sheath having a guidewire lumen, an inflation lumen, a proximal end and a distal end;

at least one electrode assembly adjacent to the guidewire lumen, wherein the at least one electrode assembly is coupled to an electrical generator and produces an electrical pulse;

a balloon assembly circumferentially arranged around a portion of the sheath and around at least one electrode assembly;

one or more liquid medium ports disposed within the sheath and within the balloon assembly; and

a pressure-wave reflective element disposed adjacent the balloon assembly;

positioning the balloon assembly adjacent an obstruction within the vasculature;

inflating the balloon assembly by delivering a liquid medium through the inflation lumen and out one or more liquid medium ports into the balloon assembly until a desired inflation pressure is obtained; and

activating the at least one electrode assembly within the balloon to produce at least one pulse of electrical energy from the electrode assembly, whereupon the electrical energy reacts with the liquid medium and generates one or more pressure waves that propagate through the balloon and disrupt at least a portion of the vascular obstruction, wherein the pressure-wave reflective element attenuates the pressure wave passing through the balloon assembly.

30. The method of claim 29, wherein the pressure-wave reflective element comprises a plurality of openings.

31. The method of claim 29, wherein the plurality of openings are between 100 and 900 microns.

32. The method of claim 29, wherein a percentage of the openings within an area of a portion of the pressure-wave reflective element is between 10 percent and 90 percent.

33. The method of claim 29, wherein an area of the pressure-wave reflective element comprises the openings and a structural mass, wherein a ratio of the openings to the structural mass within the area is between 1:

1 and 1;

10.

34. The method of claim 29, wherein the plurality of openings comprise at least one of the following shapes:

circle;

oval;

triangle;

square;

rectangle;

polygon;

diamond;

pentagon;

hexagon;

heptagon;

octagon;

nonagon; and

decagon.

35. The method of claim 34 further comprising the step of re-positioning the balloon assembly such that the balloon is adjacent another portion of the obstruction.

36. The method of claim 35 further comprising the step of moving the at least one electrode assembly within the balloon assembly.

38. The method of claim 29 further comprising the step of re-positioning at least one electrode assembly within the balloon assembly.

37. (canceled)

39-54. -54. (canceled)