Balloon atherectomy catheters with imaging

• US 10,548,478 B2
• Filed: 03/15/2013
• Issued: 02/04/2020
• Est. Priority Date: 07/01/2010
• Status: Active Grant

• Current Assignee: Avinger Inc.
• Original Assignee: Avinger Inc.
• Inventors: Simpson, John B., Gupta, Priyanshu, Zung, Michael, Lam, Wendy N., Spencer, Maegan K., Smith, Peter H., Davies, Stephen C., Spinelli, Nicholas J., McNall, Charles W., Ketai, Theodore W., Kankaria, Manish, Askew, Mark W., Stalker, Kent C. B.
• Primary Examiner(s): Lamprecht, Joel
• Application Number:
  US14/424,277
• Publication Number:
  US 20150208922A1
• Time in Patent Office: 2,517 Days
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• 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 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2017/22071 Steering
• CPC Class Codes: A61B 2017/320791 with cutter extending outside the cutting window
• CPC Class Codes: A61B 2090/3735 Optical coherence tomography [OCT]
• CPC Class Codes: A61B 5/0066 Optical coherence imaging
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 90/361 Image-producing devices, e.g. surgical cameras

Abstract

An atherectomy catheter includes an elongate flexible catheter body, a cutter near the distal end of the catheter body, a drive shaft connected to the cutter and extending within the catheter body, an imaging element near the distal end of the catheter body and an imaging shaft connected to the imaging element and extending within the catheter body. The cutter and the imaging element are mechanically isolated, and the drive shaft is configured to be axially translated relative to the imaging shaft and the catheter body.

Claims

1. An atherectomy catheter comprising:

an elongate flexible catheter body;

a cutter near the distal end of the catheter body;

an elongate distal tip connected to the catheter body at an off-axis hinge point, the elongate distal tip including a cutting window therein;

a drive shaft connected to the cutter and extending within the catheter body;

an imaging element near the distal end of the catheter body; and

an inflatable element attached to the elongate flexible catheter body proximate to the hinge point and opposite to the cutting window, the inflatable element configured to inflate to urge the cutter against a vessel wall; and

wherein the drive shaft is configured to be axially translated relative to the catheter body.

2. The atherectomy catheter of claim 1, further comprising an imaging shaft connected to the imaging element and extending within the catheter body, wherein the cutter and the imaging element are mechanically isolated from one another, and wherein the drive shaft and imaging shaft are decoupled along the length of the catheter body.

3. The atherectomy catheter of claim 1, further comprising an imaging shaft connected to the imaging element and extending within the catheter body, wherein the cutter and the imaging element are mechanically isolated from one another, and wherein the drive shaft and imaging shaft are coupled at a proximal end of the device.

4. The atherectomy catheter of claim 3, the device further comprising a handle configured to transmit torque simultaneously to the proximal end of the drive shaft and the imaging shaft, wherein the drive shaft and imaging shaft are coupled within the handle.

5. The atherectomy catheter of claim 4, wherein the handle includes a translation mechanism configured to translate the drive shaft without translating the imaging shaft.

6. The atherectomy catheter of claim 1, the cutting window sized and dimensioned so as to cause tissue to invaginate within the cutting window.

7. The atherectomy catheter of claim 1, wherein the imaging element includes an optical fiber.

8. The atherectomy catheter of claim 1, wherein the imaging element includes an optical coherence tomography imaging element.

9. An atherectomy catheter comprising:

an elongate flexible catheter body;

a cutter near the distal end of the catheter body;

a drive shaft connected to the cutter and extending within the catheter body;

an imaging element near the distal end of the catheter body; and

an imaging shaft connected to the imaging element and extending within the catheter body, wherein the drive shaft and imaging shaft are concentric, and wherein the drive shaft extends within the imaging shaft;

wherein the cutter and the imaging element are mechanically isolated; and

wherein the drive shaft is configured to be axially translated relative to the imaging shaft and the catheter body.

10. The atherectomy catheter of claim 9, wherein the drive shaft and the imaging shaft both extend substantially along a central axis of the catheter body.

11. The atherectomy catheter of claim 9, wherein the imaging element includes an optical fiber, the optical fiber extending off-axis along the length of the catheter body.

12. An atherectomy catheter comprising:

an elongate flexible catheter body;

a cutter near the distal end of the catheter body;

a drive shaft connected to the cutter and extending within the catheter body;

an imaging element near the distal end of the catheter body; and

an imaging shaft connected to the imaging element and extending within the catheter body, wherein the drive shaft and imaging shaft are concentric, and wherein the imaging shaft extends within the drive shaft;

wherein the cutter and the imaging element are mechanically isolated; and

wherein the drive shaft is configured to be axially translated relative to the imaging shaft and the catheter body.

13. The atherectomy catheter of claim 12, wherein a distal end of the drive shaft includes a clear annular portion connected to the cutter.

14. An atherectomy catheter comprising:

an elongate flexible catheter body;

a drive shaft extending within the catheter body, the drive shaft having a cutter attached thereto;

an elongate distal tip connected to the catheter body at a hinge point, the elongate distal tip including a cutting window therein; and

an inflatable body linked to both the elongate flexible catheter body and to the elongate distal tip proximate to the hinge point and opposite to the cutting window, wherein inflation of the inflatable body urges the cutter through the cutting window and against a wall of the vessel.

15. The atherectomy catheter of claim 14, further comprising a biasing mechanism configured to return the elongate distal tip to a position approximately axially aligned with the catheter body.

16. The atherectomy catheter of claim 14, wherein the biasing mechanism includes a wedge activated by placing axial force on the drive shaft.

17. The atherectomy catheter of claim 14, the cutting window having an asymmetric shape configured to prevent the cutter from hitting a distal edge of the cutting window.

18. The atherectomy catheter of claim 14, further comprising an imaging element attached to the cutter and configured to rotate therewith.

19. The atherectomy catheter of claim 18, wherein the imaging element is an optical coherence tomography imaging element.

20. The atherectomy catheter of claim 18, wherein the imaging element includes an optical fiber, the optical fiber extending through the drive shaft substantially on-axis with the catheter body.

26. The atherectomy catheter of claim 14, further comprising a sling extending along an outer surface of the inflatable body configured to link the inflatable body to both the elongated flexible catheter body and the elongated distal tip.

27. The atherectomy catheter of claim 14, wherein the hinge is positioned off of a central axis of the elongate flexible catheter body.

21. An atherectomy assembly comprising:

an elongate flexible catheter body;

a drive shaft extending within the catheter body, the drive shaft having a rotatable cutter attached thereto, wherein the drive shaft is axially movable with respect to the elongate flexible catheter body;

an optical fiber attached to the cutter and configured to rotate therewith; and

a handle having a distal end attached to the elongate body and a proximal end configured to connect the optical fiber to a light source, wherein the handle is configured such the optical fiber is axially movable with respect to the distal end and axially fixed with respect to the proximal end.

22. The atherectomy assembly of claim 21, wherein the handle includes a tube within which the optical fiber resides.

23. The atherectomy assembly of claim 22, wherein the optical fiber is configured to wind within the tube.

24. The atherectomy assembly of claim 22, wherein the tube is shaped as a ring, wherein the optical fiber is configured to conform to an outer perimeter of the tube when in a compressed configuration and to conform to an inner perimeter of the tube when in an extended configuration.

25. The atherectomy assembly of claim 21, wherein the optical fiber is configured to transmit an optical coherence tomography signal.

28. The atherectomy assembly of claim 21, further comprising an inflatable element attached to the elongate flexible catheter body.

29. The atherectomy assembly of claim 28, wherein the inflatable element is configured to urge the rotatable cutter against a vessel wall.

30. The atherectomy assembly of claim 28, wherein the inflatable element is approximately spherical.

31. The atherectomy assembly of claim 28, wherein the inflatable element is configured to block blood flow to a distal end of the optical fiber during use.

32. The atherectomy assembly of claim 21, further comprising an elongate distal tip connected to the elongate flexible catheter body at an off-axis hinge point.

33. The atherectomy assembly of claim 28, further comprising a cutting window, wherein the inflatable element is positioned opposite to the cutting window.