Laser-induced fluid filled balloon catheter

• US 10,201,387 B2
• Filed: 12/30/2015
• Issued: 02/12/2019
• Est. Priority Date: 03/13/2013
• 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
• Primary Examiner(s): Stransky, Katrina
• Assistant Examiner(s): Mendoza, Michael
• Application Number:
  US14/984,050
• Publication Number:
  US 20160184023A1
• Time in Patent Office: 1,140 Days
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 18/245 for removing obstructions in blood vessels or calculi
• CPC Class Codes: A61B 18/26 for producing a shock wave, e.g. laser lithotripsy
• CPC Class Codes: A61B 2017/22024 with a part reflecting mechanical vibrations, e.g. for focusing
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/263 the conversion of laser energy into mechanical shockwaves taking place in a liquid

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 laser-induced pressure waves to disrupt vascular blockages. The present disclosure not only provides devices and methods for using laser-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 and method that use stationary light absorbing material in lieu of and/or in combination of using liquid medium that flows into a balloon for a balloon catheter. 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. A catheter comprising:

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

a plurality of optical fibers circumferentially arranged around or adjacent to the guidewire lumen, wherein at least a portion of the plurality of optical fibers comprise a distal end, wherein each distal end of the plurality of optical fibers comprises an emitter to emit laser light, wherein the at least one emitter is configured to emit laser light energy at wavelengths of between about 300 nanometers to about 350 nanometers, at pulse durations between about 100 nanoseconds to about 150 nanoseconds, and at frequencies between about 1 pulse per second to about 250 pulses per second;

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

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 laser light emitted by the emitter and a liquid medium introduced into the balloon assembly via the one or more liquid medium ports.

2. The catheter of claim 1, wherein the pressure-wave reflective element is integrally disposed within the balloon assembly.

3. The catheter of claim 1, wherein the balloon assembly has an exterior, and

wherein the pressure-wave reflective element is disposed on the exterior of the balloon assembly.

4. The catheter of claim 1, wherein the balloon assembly has an interior, and

wherein the pressure-wave reflective element is disposed on the interior of the balloon assembly.

5. The catheter of claim 1, wherein the pressure-wave reflective element comprises a plurality of openings.

6. The catheter of claim 5, wherein the plurality of openings are between 100 and 900 microns.

7. The catheter of claim 5, 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.

8. The catheter of claim 5, 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.

9. The catheter of claim 5, 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.

10. The catheter of claim 1, wherein the at least one emitter is configured to emit laser light energy at wavelengths of about 308 nanometers, at pulse durations between about 120 nanoseconds and about 140 nanoseconds, and at frequencies between about 25 pulses per second to about 80 pulses per second.

11. The catheter of claim 1, wherein total energy output for the at least one emitter is between about 30 to about 80 millijoules per millimeter squared (mJ/mm²).

12. The catheter of claim 1, wherein the liquid medium is configured to exhibit high absorption of light energy emitted from the at least one emitter at wavelengths of between about 1 nanometer to about 1 millimeter, at pulse durations between about 1 nanosecond to about 1 second, and at frequencies between about 1 pulse per second to about 500 pulses per second.

13. 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;

a plurality of optical fibers circumferentially arranged around or adjacent to the guidewire lumen, wherein at least a portion of the plurality of optical fibers comprise a distal end, wherein each distal end of the plurality of optical fibers comprises an emitter to emit laser light, wherein the at least one emitter is configured to emit laser light energy at wavelengths of between about 300 nanometers to about 350 nanometers, at pulse durations between about 100 nanoseconds to about 150 nanoseconds, and at frequencies between about 1 pulse per second to about 250 pulses per second;

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

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 emitter within the balloon to emit at least one pulse of light energy from the emitter, whereupon the light 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.

14. The method of claim 13, wherein the pressure-wave reflective element comprises a plurality of openings.

15. The method of claim 13 further comprising the step of re-positioning the balloon assembly such that the balloon is adjacent another portion of the obstruction.

16. The method of claim 15 further comprising the step of moving the plurality of optical fibers within the balloon assembly.

17. The method of claim 16, wherein the within the plurality of optical fibers is re-positioned within the pressure-wave reflective element.

18. The method of claim 13 further comprising the step of re-positioning the plurality of optical fibers within the balloon assembly.

19. The method of claim 13, wherein the within the plurality of optical fibers is re-positioned within the pressure-wave reflective element.