ASSISTED CUTTING BALLOON

• US 20140277002A1
• Filed: 03/13/2013
• Published: 09/18/2014
• 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.
• Granted Patent: US 9,320,530 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• 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 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• 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 18/26 for producing a shock wave, e.g. laser lithotripsy
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2017/22014 the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire not applied in A61B17/22012
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2017/22062 to be filled with liquid
• CPC Class Codes: A61B 2017/22081 Treatment of vulnerable plaque
• CPC Class Codes: A61B 2018/263 the conversion of laser energy into mechanical shockwaves taking place in a liquid
• CPC Class Codes: A61B 2018/266 the conversion of laser energy into mechanical shockwaves taking place in a part of the probe
• 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 2025/109 having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A dilation balloon is wrapped in one or more patterns with a wire or braided material having diamond abrasive or other abrasive material bonded thereto. The wire or braided material is vibrated in one or more ways to enhance the cutting action of the wire abrasive. The wire abrasive may be vibrated using high, low, or even ultrasonic waves transmitted to the wire abrasive via local or remote methods. Alternatively, the dilation balloon may be dilated with a contrast media that exhibits a high absorption to laser light. The contrast material is lased with a laser fiber or fibers inserted into the balloon interior, creating a substantial shockwave that vibrates the balloon and assists in the cracking or abrading of the surrounding plaque in contact with the dilation balloon. The cutting balloon may employ the abrasive coated wires described above or cutting blades.

Claims

1. A method for performing balloon angioplasty, the method comprising the steps of:

(a) inserting an assisted cutting balloon into a target coronary segment partially occluded with plaque, the assisted cutting balloon having a dilation balloon with one or more cutting devices operably positioned on an exterior of the dilation balloon;

(b) vibrating the one or more cutting devices; and

(c) inflating the dilation balloon;

whereby the expanding dilation balloon crushes the softer portions of the plaque and the vibrating one or more cutting devices cuts the harder or calcified portions of the plaque.

2. The method according to claim 1, wherein the one or more cutting devices comprise one or more wire abrasives bound to the exterior of the dilation balloon and wherein step (a) further comprises the steps of:

inserting a guide wire into a vasculature system and past the target coronary segment; and

translating the assisted cutting balloon over the guide wire to the target coronary segment.

3. The method according to claim 2, wherein step (c) further comprises the step of:

inflating the dilation balloon with a contrast medium.

4. The method according to claim 3, further comprising the steps of:

translating a laser fiber along with the assisted cutting balloon over the guide wire to the target coronary segment, the distal end of the laser fiber terminating in the middle of the dilation balloon;

powering on a laser generator connected to a proximal end of the laser fiber;

emitting laser light from the distal end of the laser fiber at very short pulse durations creating shockwaves that propagate through the contrast medium as the dilation balloon is inflating, causing the wire abrasive to vibrate; and

cutting by the wire abrasive as it vibrates the harder or calcified portions of the plaque as the dilation balloon is inflating.

5. The method according to claim 4, wherein the translating step further comprises the step of:

enclosing the assisted cutting balloon, the guide wire, and the laser fiber into a multi-lumen catheter.

6. The method according to claim 4, wherein the emitting step further comprises the step of:

generating, by the laser generator, 308 nm laser light at pulse durations ranging from 120-140 nsec that are emitted from the distal end of the laser fiber, wherein the laser generator is an excimer laser.

7. The method according to claim 4, further comprising the step of:

assisting the crushing of the softer portions of the plaque by the shockwaves propagating within the dilation balloon.

8. The method according to claim 1, wherein step (b) further comprises the steps of:

powering on an ultrasonic apparatus having a flexible wire waveguide connected at a proximal end to the ultrasonic apparatus, and connected at a distal end to the one or more cutting devices;

transmitting ultrasonic waves from the ultrasonic apparatus through the flexible wire waveguide to the one or more cutting devices, causing the one or more cutting devices to vibrate; and

cutting by the one or more cutting devices as it vibrates the harder or calcified portions of the plaque as the dilation balloon is inflated.

9. The method according to claim 1 wherein step (c) further comprises the step of:

inflating the dilation balloon to a pressure ranging between 5 to 10 atmospheres.

10. An assisted cutting balloon for performing balloon angioplasty comprising:

a dilation balloon;

one or more cutting devices operably positioned on an exterior of the dilation balloon; and

a flexible wire waveguide connected at a distal end to the one or more cutting devices and connected at a proximal end to an ultrasonic apparatus;

whereby the ultrasonic apparatus transmits ultrasonic waves through the flexible wire waveguide to the one or more cutting devices causing the one or more cutting devices to vibrate as and/or after the dilation balloon is inflated.

11. The assisted cutting balloon for performing balloon angioplasty according to claim 10, wherein the one or more cutting devices comprise a wire abrasive bound to an exterior of the dilation balloon and further comprising:

a guide wire for translating the assisted cutting balloon to a target coronary segment partially occluded with plaque, wherein the guide wire is inserted into a vasculature system and past the target coronary segment.

12. The assisted cutting balloon for performing balloon angioplasty according to claim 10, wherein the one or more cutting device during vibration cuts the harder or calcified portions of the plaque as the dilation balloon is inflated.

13. The assisted cutting balloon for performing balloon angioplasty according to claim 10, wherein the dilation balloon is inflated to a pressure ranging between 5 to 10 atmospheres.

14. The assisted cutting balloon for performing balloon angioplasty according to claim 11, wherein the wire abrasive is diamond dust, and the wire wrap pattern of the wire abrasive bound to the dilation balloon is one or more of diamond, cross-hatch, mesh, longitudinal, radial, and helical.

15. An assisted cutting balloon for performing balloon angioplasty comprising:

a dilation balloon;

one or more cutting devices operably positioned on an exterior of the dilation balloon;

a laser light source terminating at a distal end in the interior of the dilation balloon; and

a contrast medium for inflating the dilation balloon;

whereby, as and/or after the dilation balloon is inflated with the contrast medium, the laser light source transmits pulsed laser light into the contrast medium creating shockwaves that propagate through the contrast medium causing the one or more cutting devices to vibrate.

16. The assisted cutting balloon for performing balloon angioplasty according to claim 15, wherein the one or more cutting devices comprise a wire abrasive bound to the exterior of the dilation balloon and further comprising:

a guide wire for translating the assisted cutting balloon and the laser light source to a target coronary segment partially occluded with plaque, wherein the guide wire is inserted into a vasculature system and past the target coronary segment.

17. The assisted cutting balloon for performing balloon angioplasty according to claim 15, wherein the laser light source further comprises:

a laser fiber translated along with the assisted cutting balloon to the target coronary segment;

a laser generator connected to a proximal end of the laser fiber and the distal end of the laser fiber terminates in the middle of the dilation balloon; and

a laser light emitted from the distal end of the laser fiber at very short pulse durations creating shockwaves that propagate through the contrast medium as the dilation balloon is inflating, causing the one or more cutting devices to vibrate, wherein, as the dilation balloon is inflated, the one or more cutting devices vibrate and cut harder or calcified portions of the plaque.

18. The assisted cutting balloon for performing balloon angioplasty according to claim 17, further comprising:

a multi-lumen catheter for enclosing the assisted cutting balloon, the guide wire, and the laser fiber.

19. The assisted cutting balloon for performing balloon angioplasty according to claim 15, wherein the laser light source is an excimer laser that generates 308 nm laser light at pulse durations ranging from 120-140 nsec.

20. The assisted cutting balloon for performing balloon angioplasty according to claim 16, wherein the wire abrasive is diamond dust, and the wire wrap pattern of the wire abrasive bound to the dilation balloon is one or more of diamond, cross-hatch, mesh, longitudinal, radial, and helical.