Rotational atherectomy device

• US 6,295,712 B1
• Filed: 06/20/2000
• Issued: 10/02/2001
• Est. Priority Date: 07/15/1996
• Status: Expired due to Term

• Current Assignee: Cardiovascular Systems Incorporated (Boston Scientific Corporation)
• Original Assignee: Shturman Cardiology Systems, Inc.
• Inventors: Shturman, Leonid, Nevzorov, Andrei
• Primary Examiner(s): Bryant, David P.
• Assistant Examiner(s): COMPTON, ERIC B
• Application Number:
  US09/597,959
• Time in Patent Office: 469 Days
• Field of Search: 294/23, 156/155, 156/173, 156/175, 156/189, 140/92.1
• US Class Current: 29/423
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/320008 Scrapers
• CPC Class Codes: Y10T 29/4981 Utilizing transitory attached element or associated separate material

Abstract

An atherectomy device for removing tissue from an artery. The device includes a flexible, elongated drive shaft rotatable about a guide wire, the drive shaft having an enlarged diameter tissue removal section. The drive shaft and the enlarged diameter tissue removal section are comprised of helically wound wire. Wire turns of the proximal portion of the tissue removal section have diameters that gradually increase distally at a generally constant rate thereby forming generally the shape of a cone. Wire turns of the distal portion of the enlarged diameter tissue removal section have diameters that gradually decrease distally thereby forming a generally convex distal portion. At least part of the tissue removal section includes an external coating of an abrasive material to define an abrasive segment of the drive shaft. The drive shaft may include a reduced diameter segment located near the enlarged diameter tissue removal section to facilitate smooth rotation of the drive shaft and its tissue removal section about the guide wire when the atherectomy device is rotated at high speeds. Preferably such a reduced diameter segment is provided just proximal to the enlarged diameter tissue removal section, and preferably the entire portion of the drive shaft distal to the enlarged diameter tissue removal section also has a similarly reduced diameter. The maximum outer diameter and length of the abrasive segment may be selected so that, at operational rotational speeds and under load, at least some of the wire turns of the proximal portion of the enlarged diameter tissue removal section unwind from their at-rest diameter to an effective outer diameter which is the same as or larger than the maximum outer diameter of the abrasive segment.

Claims

1. A method of manufacturing a drive shaft having an enlarged diameter tissue removal section comprising the steps of:

helically winding one or more strands of wire about an elongated mandrel having an enlarged diameter portion with a predetermined shape, thereby forming an elongated, flexible drive shaft which has an enlarged diameter tissue removal section defined by wire turns of the drive shaft; and

immersing at least the enlarged diameter tissue removal section of the drive shaft into an acidic solution to dissolve at least the enlarged diameter portion of the mandrel from within the drive shaft.

2. The method of claim 1 wherein the drive shaft wire and the enlarged diameter portion of the mandrel are made from different metals, the metal of the enlarged diameter portion of the mandrel being dissolvable in acid without substantially adversely affecting the wire of the drive shaft.

3. The method of claim 1 wherein the enlarged diameter portion of the mandrel is made from brass, and the drive shaft wire is made from stainless steel.

4. The method of claim 1 wherein the mandrel includes a round mandrel shaft to which the enlarged diameter portion is secured, the mandrel shaft and the enlarged diameter portion being made respectively from dissimilar metals.

5. The method of claim 4 wherein the mandrel shaft is made from high carbon steel.

6. The method of claim 1 wherein the enlarged diameter portion is secured to the mandrel shaft by solder.

7. The method of claim 1, wherein the mandrel includes a mandrel shaft on which the enlarged diameter portion is mounted, and wherein the mandrel shaft has a section with a substantially constant cross-section, and a distally tapered section disposed proximally relative to the enlarged diameter portion on the mandrel shaft.

8. The method of claim 7, wherein the mandrel shaft includes another distally tapered section disposed distally relative to the enlarged diameter portion on the mandrel shaft.

9. A method of manufacturing a drive shaft having an enlarged diameter tissue removal section comprising the steps of:

preparing an elongated mandrel by securing an enlarged diameter portion to an elongated mandrel shaft which has a generally constant diameter along its length, the enlarged diameter portion of the mandrel being made from a material that is dissolvable in nitric acid;

helically winding about the elongated mandrel one or more strands of wire made from a material that does not readily dissolve in nitric acid, thereby forming an elongated, flexible drive shaft which has an enlarged diameter tissue removal section defined by wire turns of the drive shaft; and

immersing at least the enlarged diameter tissue removal section of the drive shaft into an acidic solution to dissolve at least the enlarged diameter portion of the mandrel from within the drive shaft.

10. The method of claim 9 wherein the drive shaft wire is made from stainless steel.

11. The method of claim 9 wherein the enlarged diameter portion of the mandrel is made from brass.

12. The method of claim 9 wherein the acidic solution is nitric acid.

13. A method of manufacturing an atherectomy device comprising the steps of:

providing a mandrel having an elongated shaft with a generally constant diameter along its length except for an enlarged diameter portion, the enlarged diameter portion having proximal and distal sections, the proximal section having an outer surface generally in the shape of a cone extending for an entire length or nearly the entire length of the proximal section;

helically winding one or more strands of wire about the mandrel, including the enlarged diameter portion of the mandrel, to form an elongated, flexible drive shaft which has an enlarged diameter tissue removal section with a generally conical proximal portion; and

removing the mandrel from the drive shaft.

14. The method of claim 13 wherein the mandrel is removed from the drive shaft by dissolving at least the enlarged diameter portion of the mandrel in an acidic solution.

15. The method of claim 14 wherein the acidic solution is nitric acid.

16. The method of claim 13 wherein the enlarged diameter portion of the mandrel is located proximally of a distal end of the mandrel shaft.

17. The method of claim 13 further comprising the step of providing at least a portion of the enlarged diameter tissue removal section of the drive shaft with an abrasive coating.

18. The method of claim 13 wherein the mandrel includes an elongated shaft to which the enlarged diameter portion is attached.

19. The method of claim 18 wherein the elongated shaft and the enlarged diameter portion attached to the elongated shaft are made from dissimilar metals.

20. The method of claim 19 wherein the elongated shaft is made from high carbon steel.

21. The method of claim 18 wherein the enlarged diameter portion of the mandrel is made from brass.

22. The method of claim 13 wherein the drive shaft wire and the enlarged diameter portion of the mandrel, including its generally conical proximal section, are made from different metals, the metal of the enlarged diameter portion of the mandrel being dissolvable in acid without substantially adversely affecting the wire of the drive shaft.

23. A method for manufacturing an atherectomy device, the method comprising the steps of:

providing a mandrel having an elongated mandrel shaft;

mounting an enlarged diameter portion at a predetermined location on the mandrel shaft, the enlarged diameter portion having an enlarged diameter relative to a diameter of the mandrel shaft, and having a section with a conical shape;

helically winding one or more wires about the mandrel, including the enlarged diameter portion of the mandrel, to form an elongated, flexible drive shaft which has an enlarged tissue removal section with a generally conical portion; and

removing the mandrel from the drive shaft.

24. The method of claim 23, further comprising the step of making the mandrel shaft and the enlarged diameter portion respectively from dissimilar metals.

25. The method of claim 24, wherein removing the mandrel from the drive shaft comprises immersing the mandrel, at least in part, into an acidic solution to dissolve at least the enlarged diameter portion.

26. A method of manufacturing a drive shaft having an enlarged diameter tissue removal section comprising the steps of:

providing an elongated mandrel having an enlarged diameter portion with a predetermined shape having asymmetrical proximal and distal portions which are asymmetrical relative to each other;

helically winding one or more strands of wire about the elongated mandrel thereby forming an elongated, flexible drive shaft which has an enlarged diameter tissue removal section defined by wire turns of the drive shaft; and

immersing at least the enlarged diameter tissue removal section of the drive shaft into an acidic solution to dissolve at least the enlarged diameter portion of the mandrel from within the drive shaft.

27. The method of claim 26, wherein the proximal portion of the enlarged diameter portion of the mandrel has a tapered outer circumferential surface which increases distally in diameter forming generally a shape of a cone for the proximal portion, and the distal portion of the enlarged diameter portion has another tapered outer circumferential surface which decreases distally in diameter, and wherein the diameter of the proximal section increases distally at a rate of increase which is different than a rate of decrease at which the diameter of the distal section decreases distally.

28. A method of manufacturing a drive shaft having an enlarged diameter tissue removal section comprising the steps of:

preparing an elongated mandrel by securing an enlarged diameter portion to an elongated mandrel shaft which has a generally constant diameter along its length,

the enlarged diameter portion having proximal and distal portions which are asymmetric relative to each other, and the enlarged diameter portion of the mandrel being made from a material that is dissolvable in nitric acid;

helically winding about the elongated mandrel one or more strands of wire made from a material that does not readily dissolve in nitric acid, thereby forming an elongated, flexible drive shaft which has an enlarged diameter tissue removal section defined by wire turns of the drive shaft; and

immersing at least the enlarged diameter tissue removal section of the drive shaft into an acidic solution to dissolve at least the enlarged diameter portion of the mandrel from within the drive shaft.

29. The method of claim 28, wherein the proximal portion of the enlarged diameter portion of the mandrel has a tapered outer circumferential surface which increases distally in diameter forming generally a shape of a cone for the proximal portion, and the distal portion of the enlarged diameter portion has another tapered outer circumferential surface which decreases distally in diameter, and wherein a distal increase rate of the diameter of the proximal section is different than a distal decrease rate of the distal section.