IP Library Granted Patent US 11,998,311
Granted Patent B2
US 11,998,311 · App. 17/443,398 · Granted Jun 4, 2024

Guidewire positioning catheter

Inventors: Himanshu N. Patel (San Jose, CA); John B. Simpson (Woodside, CA)
Assignee: Avinger, Inc.
A61B5/066A61B17/320758A61M25/01A61M25/0138A61B2017/003A61B2017/00309A61B2017/22038A61B2017/320775A61M25/0147A61M25/0155A61M25/0172
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Quick Facts
Patent No.
US 11,998,311
App. No.
17/443,398
Granted
Jun 4, 2024
Kind
B2
Abstract

A catheter for positioning a guidewire across an occluded portion of a vessel includes an elongate catheter body, an integrated rotatable distal tip, a proximal handle region, and a catheter lumen extending through the elongate catheter body. The elongate body has a distal region configured to be bent to a set angle. The integrated rotatable distal tip includes one or more channeled flutes extending around the distal tip that are configured to be rotated in a first direction to dissect tissue and a second direction for bluntly contacting tissue. A proximal handle region includes a control for rotating the distal tip in either the first or second directions. The catheter lumen is configured to pass a guidewire.

Claims (34)

1. A catheter device for positioning a guidewire across an occluded portion of a vessel, the catheter device comprising:

a catheter body having a central lumen and a steerable distal region, the steerable distal region configured to bend laterally toward a predetermined side of the catheter body, wherein a distal end of the catheter body includes spiral shaped wedge members; and

a driveshaft extending within the central lumen and configured to rotate with respect to of the catheter body, the driveshaft coupled to and configured to rotate a distal tip having one or more cutting edges, wherein the driveshaft is configured to move longitudinally relative to the catheter body to extend the distal tip distally out of a central opening of the distal end of the catheter body and retract the distal tip proximally within the catheter body, wherein the one or more cutting edges are arranged in a spiral that is radially aligned with the spiral shaped wedge members of the distal end of the catheter body when the one or more cutting edges are extended out of the distal end of the catheter body, wherein the catheter device is configured to lock at least a portion of the distal tip in an extended position out of the central opening of the distal end of the catheter body, wherein the steerable distal region of the catheter body is configured to bend laterally toward the predetermined side of the catheter body upon application of a longitudinal pushing force on the driveshaft.

2. The catheter device of claim 1 , further comprising a handle configured to control lateral bending of the catheter body, and extension and retraction of the distal tip.

3. The catheter device of claim 2 , wherein the handle further comprises an indicator configured to indicate an extent to which the distal tip is extended.

4. The catheter device of claim 2 , wherein the handle is further configured to control rotation of the driveshaft and the distal tip.

5. The catheter device of claim 4 , wherein the handle comprises:

a first control configured to control rotation of the driveshaft and the distal tip; and

a second control configured to control lateral bending of the catheter body, and extension and retraction of the distal tip with respect to the catheter body, by controlling longitudinal movement of the driveshaft.

6. The catheter device of claim 5 , wherein the first control includes a slider component, and wherein the second control includes a rotator component.

7. The catheter device of claim 6 , wherein the slider component is configured to slide distally to extend the distal tip distally out of the catheter body, and slide further distally to bend the steerable distal region.

8. The catheter device of claim 2 , wherein the handle further comprises a lock configured to lock the catheter body in a bent configuration or a straight configuration.

9. The catheter device of claim 8 , wherein the handle further comprises a slider component configured to slide longitudinally, wherein the lock is configured to restrict movement of the slider component.

10. The catheter device of claim 2 , wherein the handle further comprises a luer connecter that provides entry to a lumen of the catheter device.

11. The catheter device of claim 1 , wherein rotation of the driveshaft is driven by a motor.

12. The catheter device of claim 1 , wherein the driveshaft and the distal tip are configured to rotate in either a clockwise direction or a counterclockwise direction.

13. The catheter device of claim 1 , wherein the steerable distal region of the catheter body includes a scaffold having a narrow solid band that extends longitudinally along the scaffold, wherein the steerable distal region is configured to bend toward the narrow solid band.

14. The catheter device of claim 1 , wherein the device includes a lock that is configured to lock at least a portion of the one or more cutting edges in the extended position.

15. The catheter device of claim 1 , wherein the one or more cutting edges are configured to extend from the distal end of the catheter body by a predetermined maximum extension when locked in the extended position.

16. A method of positioning a guidewire across an occlusion within a vessel, the method comprising:

advancing a catheter device through the vessel and toward the occlusion, the catheter device comprising:

a catheter body having a lumen and steerable distal region, wherein a distal end of the catheter body includes spiral shaped wedge members; and

a driveshaft extending within the lumen, the driveshaft coupled to a distal tip having one or more cutting edges;

crossing the occlusion by:

extending the distal tip distally from within the catheter body to expose the one or more cutting edges, wherein at least a portion of the distal tip is locked in an extended position out of a central opening of the distal end of the catheter body, and wherein the one or more cutting edges are arranged in a spiral that is radially aligned with the spiral shaped wedge members of the distal end of the catheter body when the one or more cutting edges are extended out of the distal end of the catheter body;

rotating the driveshaft to cause the distal tip to rotate and cut the occlusion with the one or more cutting edges of the distal tip; and

applying a longitudinal pushing force on the driveshaft to cause the steerable distal region of the catheter body to bend laterally toward a predetermined side of the steerable distal region and to steer the rotating distal tip within the vessel; and

positioning the guidewire through the catheter body and across the occlusion.

17. The method of claim 16 , wherein rotating the distal tip comprises rotating the distal tip in a clockwise direction and a counterclockwise direction.

18. The method of claim 16 , wherein the catheter device includes a handle having a first control and a second control, wherein rotating the distal tip comprises manipulating the first control, wherein extending the distal tip distally comprises manipulating the second control.

19. The method of claim 18 , wherein the second control controls longitudinal movement of the driveshaft.

20. The method of claim 16 , further comprising delivering fluid to a desired area within the vessel through the lumen of the catheter device.

21. The method of claim 16 , further comprising locking the steerable distal region in a bent configuration.

22. The method of claim 21 , wherein locking the steerable distal region in the bent configuration comprises restricting longitudinal movement of the driveshaft within the catheter body.

Assignments (5)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 21, 2025
From: LUMIVASCULAR, INC.
To: ZYLOX TONBRIDGE MEDICAL LIMITED
Reel/Frame 073068/0297 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 10, 2025
From: AVINGER (ASSIGNMENT FOR THE BENEFIT OF CREDITORS), LLC
To: LUMIVASCULAR, INC.
Reel/Frame 072835/0378 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 10, 2025
From: AVINGER, INC.
To: AVINGER (ASSIGNMENT FOR THE BENEFIT OF CREDITORS), LLC
Reel/Frame 072852/0136 →
SECURITY INTEREST Recorded Apr 30, 2025
From: LUMIVASCULAR, INC.
To: ZYLOX TONBRIDGE MEDICAL LIMITED
Reel/Frame 071135/0568 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 21, 2021
From: PATEL, HIMANSHU N.; SIMPSON, JOHN B.
To: AVINGER, INC.
Reel/Frame 057551/0387 →
Continuity (6)
Continuation 15480238 · Apr 5, 2017
Continuation 13929579 · Jun 27, 2013
Continuation 12689748 · Jan 19, 2010
Provisional Application 61233093 · Aug 11, 2009
Provisional Application 61173542 · Apr 28, 2009
Related Publication 20210345903A1 · Nov 11, 2021