High speed chronic total occlusion crossing devices

• US 10,357,277 B2
• Filed: 07/08/2015
• Issued: 07/23/2019
• Est. Priority Date: 07/08/2014
• Status: Active Grant

• Current Assignee: Avinger Inc.
• Original Assignee: Avinger Inc.
• Inventors: Patel, Himanshu N., Simpson, John B., Radjabi, Ryan
• Primary Examiner(s): Shi, Katherine M
• Assistant Examiner(s): Restaino, Andrew P.
• Application Number:
  US15/324,325
• Publication Number:
  US 20180146978A1
• Time in Patent Office: 1,476 Days
• Field of Search: 606159
• CPC Class Codes: A61B 1/00066 Proximal part of endoscope body, e.g. handles A61B1/0052 takes precedence
• CPC Class Codes: A61B 1/00073 with externally grooved shaft
• CPC Class Codes: A61B 1/00165 with light-conductive means, e.g. fibre optics A61B1/07 takes precedence
• CPC Class Codes: A61B 1/005 Flexible endoscopes
• CPC Class Codes: A61B 1/3137 for examination of the interior of blood vessels
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take 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 2017/00309 Cut-outs or slits
• CPC Class Codes: A61B 2017/00455 Orientation indicators, e.g. recess on the handle
• CPC Class Codes: A61B 2017/00907 for light
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2017/320775 Morcellators, impeller or propeller like means
• CPC Class Codes: A61B 2090/3614 using optical fibre
• CPC Class Codes: A61B 2090/3735 Optical coherence tomography [OCT]
• CPC Class Codes: A61B 2090/3983 Reference marker arrangements for use with image guided surgery

Abstract

An occlusion crossing device includes an outer shaft, an inner shaft, an optical fiber, and a handle attached to the inner shaft and the outer shaft. The inner shaft extends within the outer shaft. The inner shaft includes a drill tip at a distal end thereof. The optical fiber extends within the inner shaft substantially along a central axis of the inner shaft. The distal tip of the optical fiber is attached to the drill tip. The handle is configured to rotate the inner shaft and drill tip at speeds of greater than 500 rpm.

Claims

1. An occlusion crossing device comprising:

an outer shaft;

an inner shaft extending within the outer shaft, the inner shaft including a drill tip at a distal end thereof;

an optical fiber extending within the inner shaft substantially along a central axis of the inner shaft, a distal tip of the optical fiber attached to the drill tip; and

a handle attached to the inner shaft and the outer shaft and configured rotate the inner shaft and drill tip at speeds of greater than 500 rotations per minute,

wherein the inner shaft is removably coupled with the outer shaft such that the inner shaft moves longitudinally with respect to the outer shaft when a force is applied to the inner shaft in a longitudinal direction to allow the outer shaft to bend with respect to the central axis while coupled to the inner shaft.

2. The occlusion crossing device of claim 1, wherein the force is a pushing force applied in a distal direction or a pulling force applied in a proximal direction.

3. The occlusion crossing device of claim 1, wherein the inner shaft is removably coupled with the outer shaft with a lock configured to lock and unlock the inner shaft relative to the outer shaft, wherein the lock is configured to provide relative longitudinal movement of outer shaft relative to the inner shaft during bending of the outer shaft with respect to the central axis.

4. The occlusion crossing device of claim 1, wherein the outer shaft includes an articulating feature configured to allow the outer shaft to bend, the articulating feature activated by moving the inner shaft along the central axis relative to the outer shaft.

5. The occlusion crossing device of claim 4, wherein the articulating feature includes a backbone and a plurality of circumferential cuts.

6. The occlusion crossing device of claim 4, wherein the inner shaft includes an annular member configured to engage with an inner lip of the outer shaft to bend the outer shaft when the inner shaft is pushed distally.

7. The occlusion crossing device of claim 4, wherein the inner shaft includes an annular member configured to engage with an inner lip of the outer shaft to bend the outer shaft when the inner shaft is pulled proximally.

8. The occlusion crossing device of claim 1, wherein the outer shaft includes a preformed bend therein.

9. The occlusion crossing device of claim 1, wherein the outer shaft further comprises a marker positioned with respect to the preformed bend such that an orientation of the outer shaft can be determined during imaging.

10. The occlusion crossing device of claim 1, wherein the outer shaft includes a transparent distal portion configured to allow imaging with the optical fiber therethrough.

11. The occlusion crossing device of claim 1, wherein the handle is configured to rotate the inner shaft and drill tip at speeds of greater than 1,000 rotations per minute.

12. The occlusion crossing device of claim 1, wherein the handle is configured to rate the inner shaft and drill tip at speeds of greater than 500 rotations per minute such that images can be generated from the optical fiber at a rate of greater than or equal to 8 frames per second.

13. The occlusion crossing device of claim 1, wherein the optical fiber is a common path optical coherence tomography fiber.

14. The occlusion crossing device of claim 1, wherein the drill tip includes a plurality of spiral cutting edges.

15. The occlusion crossing device of claim 1, wherein the drill tip is a substantially smooth frusto-conical tip.

16. The occlusion crossing device of claim 1, further comprising a monorail guidewire lumen extending along the outer shaft.

17. The imaging occlusion crossing device of claim 1, wherein an outer diameter of the outer shaft is less than 0.08 inches.

18. The occlusion crossing device of claim 1, wherein the inner shaft is configured to be removed from the outer shaft while at least a portion of the outer shaft is in place within a vessel.

19. The occlusion crossing device of claim 1, wherein the inner and outer shafts are axially movable with respect to each other at a proximal region of the device and axially fixed at a distal region of the device when the force is applied to the inner shaft.

20. The occlusion crossing device of claim 1, wherein the inner shaft is configured to rotate with respect to the outer shaft during bending of the outer shaft with respect to the central axis.

21. The occlusion crossing device of claim 1, wherein the inner shaft is configured to be fixed at various points relative to the outer shaft so as to vary an amount that the drill tip is exposed.

22. A method of crossing an occlusion, comprising:

inserting a device into a vessel having an occlusion therein, the device having an inner shaft having an optical fiber coupled thereto and removably coupled to an outer shaft;

causing a distal end of the device to bend with respect to a central axis of the device by applying a force to the inner shaft in a longitudinal direction while the inner shaft is coupled with the outer shaft;

rotating the inner shaft relative to the outer shaft such that a drill tip on the inner shaft drills through the occlusion; and

generating images with the optical fiber at a rate of greater than or equal to 8 frames per second while rotating the inner shaft.

23. The method of claim 22, further comprising:

removing the inner shaft from the outer shaft while at least a portion of the outer shaft is in place within the vessel; and

inserting a guidewire through the outer shaft.

24. The method of claim 22, wherein causing the distal end of the device to bend comprises causing the inner shaft to displace longitudinally with respect to the outer shaft while the inner shaft is coupled with the outer shaft.

25. The method of claim 24, wherein the inner shaft is displaced longitudinally by a distance of between about 0.125 inches to about 0.2 inches with respect to the outer shaft.

26. The method of claim 22, wherein bending the distal end comprises pushing or pulling on the inner shaft.

27. The method of claim 26, further comprising using a marker on the device to orient the bent distal end of the device.

28. The method of claim 22, wherein rotating the inner shaft comprises rotating at more than 500 rotations per minute.

29. The method of claim 22, wherein rotating the inner shaft comprises rotating the inner shaft while coupled to the outer shaft.

30. The method of claim 22, wherein rotating the inner shaft comprises rotating the inner shaft while causing the distal end of the device to bend.

31. The method of claim 22, wherein the images are generated while the device is bending.