DEVICE FOR TRAVERSING VESSEL OCCLUSIONS AND METHOD OF USE

• US 20150216550A1
• Filed: 02/03/2014
• Published: 08/06/2015
• Est. Priority Date: 02/03/2014
• Status: Active Grant

• Current Assignee: Medinol Limited (Medinol USA Incorporated)
• Original Assignee: Oscillon Ltd.
• Inventors: RICHTER, Jacob, PANSKY, Amir
• Granted Patent: US 10,342,570 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• 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

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 member, for example a compression spring, to oscillate a drilling component. The drilling component at the distal end of the catheter tip has combined longitudinal stiffness for penetrating a total or partial occlusion and high axial (lateral) flexibility to improve deliverability and crossability of a catheter through a partially occluded vessel or a tortuous vessel, and may taper distally. The system of the invention includes the apparatus and a control unit to permit adjustment of the frequency or amplitude of oscillation of the drilling component. Also provided is a method for oscillating a drilling component using a pulling member and a spring member and a method of traversing an occlusion.

Claims

1. An apparatus, comprising:

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

a spring member having a proximal end and a distal end, said proximal end of said spring member being affixed to said distal end of said catheter, said spring member having at least two neighboring coils with open construction;

a drilling component contiguous with said distal end of said spring member and functionally attached thereto, said drilling component comprising a spring having at least two neighboring coils that are tightly packed; and

a pulling member housed within said catheter, said pulling member having a proximal end and a distal end, said distal end of said pulling member affixed to a distal structure selected from the group consisting of said spring member and said drilling component.

2. The apparatus of claim 1, wherein said pulling member, when pulled and released compresses and releases said spring member thereby effecting at least one oscillation of said drilling component.

3. The apparatus of claim 1, wherein said drilling component tapers distally.

4. The apparatus of claim 3, wherein said spring member tapers distally.

5. The apparatus of claim 3, wherein said drilling component has an outer diameter that tapers distally and an inner luminal diameter that is constant or near constant.

6. The apparatus of claim 3, wherein said drilling component has an outer diameter that tapers distally at a first rate and an inner luminal diameter that tapers distally at a second rate, said second rate less than said first rate.

7. The apparatus of claim 5 or 6, wherein said spring member has an outer diameter that tapers distally and an inner luminal diameter that is constant.

8. The apparatus of claim 5 or 6, wherein said spring member has an outer diameter that tapers distally at a first rate and an inner luminal diameter that tapers distally at a second rate, said second rate less than said first rate.

9. The apparatus of claim 1 or 2, wherein said pulling member is attached to said drilling component.

10. The apparatus of claim 1 or 2, wherein said pulling member is attached to said spring member.

11. The apparatus of claim 1 or 2, wherein said spring member is a compression spring, and said pulling member is affixed to said distal end of said spring member.

12. The apparatus of claim 1 or 2, wherein said spring member is selected from the group consisting of:

a helical spring, a leaf spring, a bellows, and a compressible polymer, and said pulling member is affixed to said distal end of said spring member.

13. The apparatus of claim 1 or 2, further comprising a vibrational energy source operably connected to said proximal end of said pulling member, wherein said vibrational energy source oscillates said drilling component by repeatedly pulling and releasing said pulling member.

14. The apparatus of claim 13, wherein said vibrational energy source is selected from the group consisting of:

an engine having a reciprocating member, a shaker, an actuator, and a solenoid.

15. The apparatus according to claim 1 or 2, further comprising a catheter anchoring device.

16. A system, comprising:

the apparatus of claim 13; and

a control unit adapted to control said vibrational energy source.

17. The system according to claim 16, wherein said oscillation comprises at least one frequency and at least one amplitude, and said at least one frequency and at least one amplitude are independently adjustable via said control unit.

18. The system according to claim 16, wherein said oscillation comprises at least one frequency and at least one amplitude, said system further comprising a sensor to assist controlling said frequency or amplitude, and said control unit further comprising a processor functionally connected to said sensor, said processor being capable of analyzing input from said sensor.

19. The system according to any one of claims 16-18, wherein said control unit further comprises an operator interface unit.

20. The system according to claim 16, further comprising a tension adjustment mechanism to compensate for variations in pulling member path length when said catheter includes curvatures.

21. A method of traversing a catheter through a vessel occlusion comprising:

introducing into said vessel the apparatus of claim 13;

positioning said drilling component in contact with said occlusion; and

generating a series of pulling forces from said vibrational energy source upon said pulling member thereby oscillating said drilling component at an amplitude and frequency sufficient to penetrate said occlusion.

22. The method of claim 21, further including advancing said catheter through said occlusion as said drilling component penetrates said occlusion.

23. The method of claim 21, wherein said generating step includes oscillating said drilling component at an amplitude and frequency sufficient to maneuver said catheter around obstacles in said vessel.