Atherectomy medical device

• US 10,441,311 B2
• Filed: 03/31/2016
• Issued: 10/15/2019
• Est. Priority Date: 04/02/2015
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Smith, Paul, Schwartz, Bernard B., Raybin, Samuel
• Primary Examiner(s): Fishback, Ashley L
• Application Number:
  US15/086,965
• Publication Number:
  US 20160287284A1
• Time in Patent Office: 1,293 Days
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/32075 Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
• 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 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/22079 with suction of debris
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2218/007 Aspiration

Abstract

Medical devices and methods for using medical devices are disclosed. A rotational atherectomy device may include an elongate shaft having a proximal end region, a distal end region and a lumen extending therein. The medical device may also include a cutting member positioned adjacent the distal end region of the elongate shaft. The cutting member may be radially expandable. The medical device may also include a sizing member positioned adjacent the cutting member. The sizing member may be radially expandable, and the radial expansion of the cutting member may be limited by radial expansion of the sizing member.

Claims

1. An atherectomy device, comprising:

an elongate shaft having a proximal end region, a distal end region and a lumen extending therein;

a cutter positioned adjacent the distal end region of the elongate shaft, wherein the cutter is radially expandable and includes an outermost radial extent, wherein the cutter includes a plurality of blade members, wherein each blade member is radially expandable independent of the remainder of blade members; and

a guide positioned adjacent the cutter, wherein the guide is radially expandable and includes an outermost radial extent, wherein the outermost radial extent of the cutter is offset a fixed radial distance from the outermost radial extent of the guide, wherein radial expansion of the cutter is directly proportional to radial expansion of the guide.

2. The device of claim 1, wherein the guide includes one or more struts extending along and away from a central longitudinal axis of the guide.

3. The device of claim 1, wherein the guide includes a distal tip and a lumen extending therein, and wherein the lumen of the guide is in communication with the lumen of the elongate shaft.

4. The device of claim 1, wherein the plurality of blade members are spaced around a central longitudinal axis of the cutter.

5. The device of claim 1, wherein the guide includes a plurality of struts, and wherein the struts are spaced around a central longitudinal axis of the guide.

6. The device of claim 5, wherein the plurality of blade members are spaced around a central longitudinal axis of the cutter.

7. The device of claim 6, wherein the plurality of blade members are longitudinally aligned with the plurality of struts.

8. The device of claim 6, wherein the struts have an outermost extent, wherein the blade members have an outermost extent, and wherein the outermost extent of the blade members is located closer to the central longitudinal axis than the outermost extent of the struts at any expanded state.

9. The device of claim 6, wherein one or more of the plurality of struts are configured to engage a portion of a vessel wall, and when the one or more of the plurality of struts is engaged with the vessel wall, the blade member aligned with the one or more of the plurality of struts is spaced radially away from the vessel wall a predetermined distance.

10. The device of claim 6, further comprising a plurality of base members, wherein each base member includes at least one strut and at least one blade member, and wherein each base member is configured to radially flex independently of the other base members.

11. The device of claim 6, further comprising one or more aspiration ports positioned at the distal end region of the elongate shaft, wherein the cutter includes a lumen extending therein, and wherein the aspiration ports are in communication with the lumen of the cutter.

12. The device of claim 1, further comprising one or more aspiration ports, wherein the one or more aspiration ports are in communication with the lumen of the elongate shaft.

13. The device of claim 1, wherein the lumen of the elongate shaft is sized to receive a guidewire or dilator therein when the atherectomy device is advanced over the guidewire or dilator.

14. An atherectomy device, comprising:

an elongate shaft having a proximal end region, a distal end region and a lumen extending therein;

a cutter positioned adjacent the distal end region of the elongate shaft, wherein the cutter is radially expandable and has an outermost radial extent, wherein the cutter includes a plurality of blade members, wherein one or more of the blade members can flex independently of the remaining blade members; and

a guide positioned adjacent the cutter, wherein the guide is radially expandable and has an outermost radial extent, and wherein the atherectomy device includes a fixed radial offset, wherein the fixed radial offset is defined as a fixed radial distance between the outermost radial extent of the cutter and the outermost radial extent of the guide, wherein radial expansion of the cutter is directly proportional to radial expansion of the guide.

15. The device of claim 14, wherein the guide includes a plurality of struts, wherein the struts are spaced around a central longitudinal axis of the guide, and wherein the plurality of blade members are spaced around a central longitudinal axis of the cutter.

16. The device of claim 15, wherein the plurality of struts are longitudinally aligned with the plurality of blade members.

17. The device of claim 16, wherein one or more of the longitudinally aligned struts can flex independently of the remaining struts.

18. The device of claim 14, wherein the radial offset is defined such that the outermost radial extent of the cutter is positioned closer to a central longitudinal axis of the cutter than the outermost radial extent of the guide.

19. An atherectomy device, comprising:

an elongate shaft having a proximal end region, a distal end region and a lumen extending therein;

a guide positioned adjacent the distal end region of the elongate shaft, wherein the guide is radially expandable;

a cutter positioned adjacent the guide, wherein the cutter is radially expandable, and wherein radial expansion of the cutter is directly proportional to radial expansion of the guide; and

one or more channels extending between the elongate shaft, the guide and the cutter.