ROTATABLE MEDICAL DEVICE

• US 20160157886A1
• Filed: 12/01/2015
• Published: 06/09/2016
• Est. Priority Date: 12/04/2014
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Augustin, Tate, WasDyke, Joel M.
• Granted Patent: US 10,405,879 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 2017/00845 of moving parts with respect to each other
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320052 Guides for cutting instruments by marking A61B2090/395

Abstract

A rotational atherectomy device advanceable over a guidewire. The rotational atherectomy device includes a drive shaft rotatably extending through an outer tubular member to rotate a cutting member positioned at a distal end thereof. The rotational atherectomy device further includes an insert positioned within the cutting member for frictional contact with the guidewire.

Claims

1. A rotational atherectomy device, comprising:

an outer tubular member having a lumen extending therethrough;

a cutting member rotationally positioned at a distal end of the outer tubular member;

a drive shaft extending through the lumen of the outer tubular member, the drive shaft rotatable relative to the outer tubular member to rotate the cutting member; and

an insert positioned within the cutting member, the insert including an opening extending therethrough for passing a guidewire therethrough.

2. The rotational atherectomy device of claim 1, wherein a distal portion of the drive shaft extends into a bore of the cutting member.

3. The rotational atherectomy device of claim 2, wherein the insert is positioned in the bore of the cutting member distal of a distal end of the drive shaft.

4. The rotational atherectomy device of claim 2, wherein the drive shaft includes a guidewire lumen extending therethrough longitudinally aligned with the opening of the insert.

5. The rotational atherectomy device of claim 4, wherein the guidewire lumen has a diameter and the opening of the insert has a diameter less than the diameter of the guidewire lumen.

6. The rotational atherectomy device of claim 1, wherein the insert includes an inner surface defining the opening of the insert, wherein at least a portion of the inner surface is nonparallel to a central longitudinal axis of the drive shaft.

7. The rotational atherectomy device of claim 6, wherein the inner surface tapers radially outward from the central longitudinal axis in a distal direction.

8. The rotational atherectomy device of claim 7, wherein the inner surface tapers radially outward in a distal direction from a mid region of the insert to a distal tip of the insert.

9. The rotational atherectomy device of claim 8, wherein the inner surface tapers radially outward in a proximal direction from the mid region of the insert to a proximal end of the insert.

10. The rotational atherectomy device of claim 7, wherein the bore has a diameter greater than the diameter of the opening of the insert.

11. The rotational atherectomy device of claim 1, wherein the insert includes an inner surface defining the opening of the insert, the inner surface having a surface roughness R_a of 0.4 micrometers or less.

12. The rotational atherectomy device of claim 1, wherein the insert includes an inner surface defining the opening of the insert, the inner surface having a surface roughness R_a of 0.2 micrometers or less.

13. A rotational atherectomy device, comprising:

an outer tubular member having a lumen extending therethrough;

a cutting member rotationally positioned at a distal end of the outer tubular member, the cutting member including a central longitudinal bore extending therethrough;

a drive shaft extending through the lumen of the outer tubular member, a distal end region of the drive shaft extending into the bore of the cutting member, the drive shaft rotatable relative to the outer tubular member to rotate the cutting member; and

an insert positioned within the bore of the cutting member, the insert including an opening extending therethrough axially aligned with the bore of the cutting member.

14. The rotational atherectomy device of claim 13, wherein the drive shaft includes a guidewire lumen extending therethrough axially aligned with the opening of the insert.

15. The rotational atherectomy device of claim 14, wherein the guidewire lumen has a diameter and the opening of the insert has a diameter less than the diameter of the guidewire lumen.

16. The rotational atherectomy device of claim 13, wherein the cutting member includes a distal opening axially aligned with the opening of the insert, the distal opening of the cutting member having a diameter greater than or equal to a diameter of the opening of the insert.

17. The rotational atherectomy device of claim 13, wherein the insert includes an inner surface defining the opening of the insert, wherein at least a portion of the inner surface is nonparallel to a central longitudinal axis of the drive shaft.

18. The rotational atherectomy device of claim 13, wherein the insert includes an inner surface defining the opening of the insert, the inner surface having a surface roughness R_a of 0.4 micrometers or less.

19. A method of creating or enlarging a passageway through an occlusion in a body lumen, comprising:

advancing a guidewire through a body lumen to a location proximate an occlusion;

advancing a rotational atherectomy device through the body lumen over the guidewire to a location proximal of the occlusion in the body lumen, the rotational atherectomy device including a rotatable drive shaft extending through an outer tubular member to rotatably drive a cutting member positioned at a distal end of the outer tubular member, and an insert positioned within the cutting member, wherein the guidewire extends through an opening of the insert and a guidewire lumen of the drive shaft; and

rotating the cutting member relative to the guidewire with the drive shaft while advancing the cutting member through the occlusion.

20. The method of claim 19, wherein a coefficient of static friction between the insert and the guidewire is less than 0.25.