Granted Patent B2

US 12,257,029 · App. 18/416,264 · Granted Mar 25, 2025

Inventors: John B. Simpson (Woodside, CA); Himanshu N. Patel (San Jose, CA); Michael Zung (San Carlos, CA); Charles W. McNall (Cottonwood Heights, UT); Priyanshu Gupta (Hornsby, AU); Maegan K. Spencer (Emerald Hills, CA); Christopher B. White (San Jose, CA); Dennis W. Jackson (San Francisco, CA); John F. Black (Irmo, SC)

Assignee: Avinger, Inc.

A61B5/0084A61B5/0035A61B5/0036A61B5/0062A61B5/0066A61B5/02007A61B5/6852A61B6/12A61B6/485A61B6/487A61B8/0841A61B17/32002A61B17/320758A61B90/37A61B90/39A61B2017/00057A61B2017/003A61B2017/00778A61B2017/22068A61B2090/306A61B2090/3614A61B2090/3735A61B2090/376A61B2090/3966A61B2090/3983A61B2217/007A61B2562/0233F04C2270/0421

Abstract

Claims (34)

1. A method of forming a passage through an occlusion or lesion, the method comprising:

advancing an occlusion crossing catheter into a body lumen, the occlusion crossing catheter having an elongate body, a guidewire lumen extending within the elongate body from a proximal end of the elongate body to an opening at a distal end of the elongate body, a rotatable tip at the distal end of the elongate body, and an optical coherence tomography (OCT) sensor comprising an optical fiber coupled with the rotatable tip;

automatically rotating the rotatable tip in a first direction relative to the elongate body of the occlusion crossing catheter such that the OCT sensor rotates;

rotating repeatedly the rotatable tip alternately between the first direction and a second direction;

imaging a region of the body lumen surrounding the occlusion crossing catheter using the OCT sensor;

passing the rotatable distal tip past the occlusion or lesion in the body lumen;

advancing a guidewire past the occlusion or lesion by passing the guidewire through the guidewire lumen of the occlusion crossing catheter;

withdrawing the occlusion crossing catheter from the body lumen and leaving the guidewire in the body lumen; and

inserting an atherectomy catheter over the guidewire and into the body lumen, wherein the atherectomy catheter comprises an atherectomy catheter elongate body, an atherectomy cutter including a cutter edge, and an atherectomy catheter optical coherence tomography (OCT) imaging sensor.

2. The method of claim 1 , wherein the atherectomy catheter optical fiber is configured to wrap around a central lumen within the atherectomy catheter elongate body as the atherectomy catheter rotatable distal region rotates, and advancing the occlusion crossing catheter into the body lumen comprises advancing the occlusion crossing catheter comprising the atherectomy catheter optical fiber configured to wrap around the central lumen into the body lumen.

3. The method of claim 1 , wherein the atherectomy catheter elongate body includes at least one marker configured to obstruct imaging from the OCT sensor at least once per rotation of the rotatable distal region, and advancing the occlusion crossing catheter into the body lumen comprises advancing the occlusion crossing catheter comprising the atherectomy catheter elongate body including the at least one marker into the body lumen.

4. The method of claim 1 , wherein the OCT imaging sensor provides information about a tissue during a cutting pass after the cutter edge has interacted with the tissue.

5. The method of claim 1 , wherein the OCT imaging sensor provides information about a tissue during a cutting pass prior to the cutter edge interacting with the tissue.

6. The method of claim 1 , wherein the atherectomy catheter comprises a hollow tissue storage area distal to the atherectomy catheter cutter, and advancing the occlusion crossing catheter into the body lumen comprises advancing the atherectomy catheter having the hollow tissue storage area distal to the atherectomy catheter cutter into the body lumen.

7. The method of claim 1 , wherein the step of inserting an atherectomy catheter comprises advancing the cutter edge of the atherectomy catheter cutter so that it is positioned distally to the occlusion or lesion.

8. The method of claim 7 , further comprising cutting, with the cutter edge of the atherectomy catheter, tissue from a wall of the body lumen in a pull-to-cut configuration.

9. The method of claim 1 , wherein a distal end of the occlusion crossing catheter rotatable tip is less than 3 mm from the imaging sensor, and advancing the occlusion crossing catheter into the body lumen comprises advancing the occlusion crossing catheter having the distal end of the occlusion crossing catheter rotatable tip less than 3 mm from the imaging sensor into the body lumen.

10. The method of claim 1 , wherein the step of advancing a guidewire is performed after the step of passing the rotatable distal tip past the occlusion or lesion in the body lumen.

11. The method of claim 1 , wherein the guidewire lumen comprises an offset guidewire lumen, and advancing the guidewire past the occlusion or lesion comprises passing the guidewire through the offset guidewire lumen of the occlusion crossing catheter.

12. The method of claim 1 , wherein the guidewire lumen comprises a central guidewire lumen, and advancing the guidewire past the occlusion or lesion comprises passing the guidewire through the central guidewire lumen of the occlusion crossing catheter.

13. The method of claim 1 , wherein the step of passing the rotatable distal tip past the occlusion or lesion in the body lumen takes place before the step of advancing a guidewire.

14. The method of claim 1 , where the step of automatically rotating repeatedly the rotatable tip alternately between the first direction and a second direction comprises automatically rotating the rotatable tip a substantially equivalent number of rotations in the first and second directions.

15. The method of claim 1 , wherein the step of automatically rotating the rotatable tip comprises separating tissue in the body lumen.

16. A method of forming a passage through an occlusion or lesion, the method comprising:

advancing an occlusion crossing catheter into a body lumen, the occlusion crossing catheter having an elongate body, a guidewire lumen extending within the elongate occlusion crossing catheter body from a proximal end of the elongate body to an opening at a distal end of the elongate body, a rotatable tip at the distal end of the elongate body, and an optical coherence tomography (OCT) sensor comprising an optical fiber coupled with the rotatable tip;

automatically rotating the rotatable tip in a first direction relative to the elongate body of the occlusion crossing catheter such that the OCT sensor rotates;

rotating repeatedly the rotatable tip alternately between the first direction and a second direction;

imaging a region of the body lumen surrounding the occlusion crossing catheter using the occlusion crossing catheter OCT sensor;

passing the occlusion crossing catheter rotatable distal tip past the occlusion or lesion in the body lumen;

advancing a guidewire past the occlusion or lesion by passing the guidewire through the guidewire lumen of the occlusion crossing catheter;

withdrawing the occlusion crossing catheter from the body lumen;

inserting an atherectomy catheter over the guidewire and into the body lumen, wherein the atherectomy catheter comprises an elongate body, an atherectomy cutter including a cutter edge, an optical coherence tomography (OCT) imaging sensor, and a hollow tissue storage area distal to the atherectomy catheter cutter;

advancing the atherectomy catheter cutter edge so that it is positioned past the occlusion or lesion; and

cutting, with the cutter edge of the atherectomy catheter, tissue from a wall of the body lumen in a pull-to-cut configuration.

Assignments (5)

Continuity (7)

References Cited (400)