Occlusion-crossing devices

• US 9,949,754 B2
• Filed: 10/10/2013
• Issued: 04/24/2018
• Est. Priority Date: 03/28/2011
• Status: Active Grant

• Current Assignee: Avinger Inc.
• Original Assignee: Avinger Inc.
• Inventors: Newhauser, Richard R., Askew, Mark W.
• Primary Examiner(s): David, Shaun L
• Application Number:
  US14/433,786
• Publication Number:
  US 20150272615A1
• Time in Patent Office: 1,657 Days
• 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 2017/003 Steerable
• CPC Class Codes: A61B 2017/00336 with a protective sleeve, e.g. retractable or slidable
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320052 Guides for cutting instruments
• CPC Class Codes: A61B 2017/320056 Tunnelers
• CPC Class Codes: A61B 2090/3735 Optical coherence tomography [OCT]

Abstract

A catheter device for crossing occlusions includes an elongate catheter shaft, a rotatable tip configured to rotate relative to the elongate catheter shaft, a drive shaft, and an OCT imaging sensor. The rotatable tip includes a housing coupled with the elongate catheter shaft and cutting wedges extendable from the housing. The drive shaft has a central lumen extending therethrough and extends within the elongate catheter shaft. The drive shaft is coupled with the wedges and is configured to rotate the rotatable tip. The OCT sensor includes an optical fiber coupled with the rotatable tip and configured to rotate therewith. The elongate catheter shaft is configured to move axially over the drive shaft to extend and retract the wedges from the housing while maintaining a fixed position of the imaging sensor relative to the cutting wedges.

Claims

1. A catheter device for crossing occlusions, the device comprising:

an elongate catheter shaft;

a rotatable tip configured to rotate relative to the elongate catheter shaft, wherein the rotatable tip includes a housing coupled with the elongate catheter shaft and cutting wedges extendable from the housing;

a drive shaft extending within the elongate catheter shaft, coupled with the wedges, and configured to rotate the rotatable tip; and

an OCT imaging sensor comprising an optical fiber coupled with the rotatable tip and configured to rotate therewith;

wherein the elongate catheter shaft is configured to move axially over the drive shaft to extend and retract the wedges from the housing while maintaining a fixed position of the imaging sensor relative to the cutting wedges.

2. The catheter of claim 1, further comprising a handle axially fixed to the drive shaft, wherein the elongate catheter shaft is configured to move axially relative to the handle to control the extension of the wedges from the housing.

3. The catheter of claim 1, wherein the elongate catheter shaft is configured to move distally over the drive shaft to position the wedges in a retracted configuration and to move proximally over to the drive shaft to position the wedges in an extended configuration.

4. The catheter of claim 3, wherein distal movement of the catheter shaft pushes the housing over the wedges, and wherein proximal movement of the catheter pulls the housing off of the wedges.

5. The catheter of claim 1, wherein the cutting wedges comprise spiral wedges.

6. The catheter device of claim 5, wherein the housing includes spiral slots configured such that the spiral wedges are extendable therethrough.

7. The catheter device of claim 1, wherein the optical fiber is configured to wrap around the drive shaft.

8. The catheter of claim 1, further comprises a torque knob connected to the elongate catheter shaft and configured to translate the elongate catheter shaft without translating the drive shaft or the optical fiber.

9. The catheter of claim 1, wherein the elongate catheter shaft includes an imaging window therein, wherein the imaging window has a length that is greater than or equal to a length of the wedges when the wedges are extended from the housing.

10. The catheter of claim 1, wherein the drive shaft includes a central lumen extending therethrough configured to pass a guidewire.

11. A method of crossing an occlusion, the method comprising:

inserting a catheter into a lumen, the catheter including an elongate catheter shaft and a rotatable tip;

extending cutting wedges from a housing of the rotatable tip by pulling the elongate catheter shaft proximally;

rotating the housing and the cutting wedges by rotating a drive shaft attached to the cutting wedges to cut through tissue within the lumen; and

imaging the lumen with an OCT sensor attached to the rotatable tip.

12. The method of claim 11, further comprising retracting the wedges into the housing by pushing the elongate catheter shaft distally.

13. The method of claim 12, wherein imaging the lumen comprises maintaining the OCT sensor at a fixed location relative to the wedges both when the wedges are extended from the housing and when the wedges are retracted into the housing.

14. The method of claim 11, wherein extending the cutting wedges comprises activing a mechanism on a handle attached to the catheter.

15. The method of claim 11, wherein the imaging sensor includes an optical fiber.

16. The method of claim 15, further comprising wrapping the optical fiber around the drive shaft.

17. The method of claim 11, wherein rotating the housing and the cutting wedges comprises rotating the housing and cutting wedges alternately clockwise and counterclockwise.

18. The method of claim 17, wherein each alternate rotation comprises a substantially equivalent number of revolutions.

19. The method of claim 11, wherein the drive shaft includes a central lumen therein, the method further comprising extending a guidewire through the central lumen.