Device for Traversing Vessel Occlusions and Method of Use

• US 20160183963A1
• Filed: 08/02/2015
• Published: 06/30/2016
• Est. Priority Date: 02/09/2010
• Status: Abandoned Application

• Current Assignee: Medinol Limited (Medinol USA Incorporated)
• Original Assignee: Medinol Limited (Medinol USA Incorporated)
• Inventors: BEN MOSHE, Eyal, RICHTER, Jacob, PANSKY, Amir
• Application Number:
  US14/816,014
• Publication Number:
  US 20160183963A1
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 2017/22042 Details of the tip of the guide wire
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2017/320069 for ablating tissue
• CPC Class Codes: A61B 2017/32007 with suction or vacuum means
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure

Abstract

An apparatus, system, and method for re-canalization or opening a passage through an occlusion in a blood vessel is provided. The apparatus and method, which are appropriate for cardiovascular and peripheral vessels, use a pulling member and a spring element, for example a compression spring, to oscillate a distal component disposed at a distal end of the spring element. The apparatus further includes a sleeve covering the spring element and at least a portion of the distal component. The sleeve may reduce friction between the spring element and the vessel lumen as the spring element vibrates during operation of the apparatus. The sleeve may also serve to protect or seal the spring element from blood and/or plaque debris that is loosened from an occlusion during a re-canalization procedure.

Claims

1. A flexible catheter tip, comprising:

a spring element having an outer diameter;

a distal component coupled to a distal end of the spring element; and

a sleeve having an inner diameter that is greater than the outer diameter of the spring element, the sleeve covering at least a portion of the spring element.

2. The flexible catheter tip of claim 1, wherein the spring element comprises the distal component.

3. The flexible catheter tip of claim 1, wherein the distal component comprises a cap.

4. The flexible catheter tip of claim 3, wherein the cap comprises a material selected from the group consisting of:

a metal and a polymer.

5. The flexible catheter tip of claim 1, wherein an outer diameter of the distal component tapers distally at a first rate to a distal end of the distal component.

6. The flexible catheter tip of claim 5, wherein the distal component comprises an inner diameter that does not taper at the first rate.

7. The flexible catheter tip of claim 1, further comprising a fixation means coupling the sleeve to the distal component.

8. The flexible catheter tip of claim 7, wherein the fixation means is disposed on an inner surface of the sleeve and an outer surface of the distal component substantially sealing the sleeve and the distal component.

9. The flexible catheter tip of claim 7, wherein the fixation means comprises a polyimide glue.

10. The flexible catheter tip of claim 1, wherein the spring element has a plurality of coils, each of the plurality of coils spaced at a first distance when the spring element is in a resting state.

11. The flexible catheter tip of claim 10, wherein the distal component comprises a plurality of coils, each of the plurality of distal component coils spaced at a second distance that is less than the first distance.

12. The flexible catheter tip of claim 1, further comprising a pulling member having a proximal and a distal end, wherein the distal end of the pulling member is affixed to a distal structure selected from the group consisting of the spring element and the distal component.

13. The flexible catheter tip of claim 12, wherein the pulling member, when pulled and released compresses and releases the spring element thereby effecting at least one oscillation of the distal component.

14. An apparatus for penetrating a vessel occlusion, the apparatus comprising:

a flexible catheter having a proximal end and a distal end;

a spring element having an outer diameter, a proximal end, and a distal end, the proximal end of said spring element being affixed to the distal end of the catheter;

a distal component coupled to a distal end of the spring element; and

a sleeve having an inner diameter that is greater than the outer diameter of the spring element, the sleeve covering at least a portion of the spring element.

15. The apparatus of claim 14, wherein the spring element comprises the distal component.

16. The apparatus of claim 14, wherein the distal component comprises a cap.

17. The apparatus of claim 16, wherein the cap comprises a material selected from the group consisting of:

a metal and a polymer.

18. The apparatus of claim 14, wherein an outer diameter of the distal component tapers distally at a first rate to a distal end of the distal component.

19. The apparatus of claim 18, wherein the distal component comprises an inner diameter that does not taper at the first rate.

20. The apparatus of claim 14, further comprising a connection means coupled at a distal end of the catheter and coupled at a proximal end of the sleeve.

21. The apparatus of claim 20, wherein the connection means comprises a heat shrink tube.

22. The apparatus of claim 20, wherein the connection means substantially seals the sleeve and the catheter.

23. The apparatus of claim 20, wherein the connection means is pliable.

24. The apparatus of claim 14, further comprising a fixation means coupling the sleeve to the distal component.

25. The apparatus of claim 24, wherein the fixation means is disposed on an inner surface of the sleeve and an outer surface of the distal component substantially sealing the sleeve and the distal component.

26. The apparatus of claim 24, wherein the fixation means comprises a polyimide glue.

27. The apparatus of claim 14, wherein the spring element has a plurality of coils, each of the plurality of coils spaced at a first distance when the spring element is in a resting state.

28. The apparatus of claim 27, wherein the distal component has a plurality of coils, each of the plurality of distal component coils, each of the plurality of distal component coils spaced at a second distance that is less than the first distance.

29. The apparatus of claim 14, further comprising a gap between the sleeve and catheter.

30. The apparatus of claim 14, further comprising a pulling member located within the flexible catheter, the pulling member having a proximal and a distal end, the distal end of the pulling member is affixed to a distal structure selected from the group consisting of the spring element and the distal component.

31. The apparatus of claim 30, wherein the pulling member, when pulled and released compresses and releases the spring element thereby effecting at least one oscillation of the distal structure.

32. The apparatus of any one of claims 14-31, further comprising:

a vibrational energy source located external of the catheter and operably connected to the proximal end of the pulling member, wherein the vibrational energy source is adapted to generate at least one oscillation in the distal component via the pulling member and the spring element by pulling and releasing the pulling member.

33. A system, comprising:

the apparatus of claim 32; and

a control unit adapted to control said vibrational energy source.

34. The system of claim 33, further comprising a sensor, and a processor functionally connected to the sensor and operably connected to the control unit, the processor being capable of analyzing input from the sensor.