Occlusion-crossing devices, imaging, and atherectomy devices

• US 8,644,913 B2
• Filed: 03/28/2012
• Issued: 02/04/2014
• Est. Priority Date: 03/28/2011
• Status: Active Grant

• Current Assignee: Avinger Inc.
• Original Assignee: Avinger Inc.
• Inventors: Simpson, John B., Patel, Himanshu N., Zung, Michael, McNall, Charles W., Gupta, Priyanshu, Spencer, Maegan K., White, Christopher B., Jackson, Dennis W., Black, John F.
• Primary Examiner(s): Le, Long V.
• Assistant Examiner(s): IMPINK, BRADLEY GERALD
• Application Number:
  US13/433,049
• Publication Number:
  US 20120253186A1
• Time in Patent Office: 678 Days
• Field of Search: None
• US Class Current: 600/478
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• 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 2017/00057 Light
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61B 2090/306 using optical fibres
• CPC Class Codes: A61B 2090/3614 using optical fibre
• CPC Class Codes: A61B 2090/3735 Optical coherence tomography [OCT]
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 2090/3983 Reference marker arrangements for use with image guided surgery
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61B 2562/0233 Special features of optical sensors or probes classified in A61B5/00
• CPC Class Codes: A61B 5/0035 adapted for acquisition of images from more than one imaging mode, e.g. combining MRI and optical tomography
• CPC Class Codes: A61B 5/0036 including treatment, e.g., using an implantable medical device, ablating, ventilating
• CPC Class Codes: A61B 5/0062 Arrangements for scanning
• 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 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/6852 : Catheters
• CPC Class Codes: A61B 6/12 : Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/485 : involving fluorescence X-ray imaging
• CPC Class Codes: A61B 6/487 : involving fluoroscopy
• CPC Class Codes: A61B 8/0841 : for locating instruments
• CPC Class Codes: A61B 90/37 : Surgical systems with images on a monitor during operation
• CPC Class Codes: A61B 90/39 : Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: F04C 2270/0421 : Controlled or regulated

Abstract

The present invention relates to: (1) guidewire support/placement catheters; (2) support/placement catheters with imaging; (3) atherectomy catheters, (4) atherectomy catheters with imaging, (5) occlusion crossing catheters, and (6) occlusion crossing catheters with imaging as well as methods for using them to treat disorders (and particularly peripheral artery disease) and systems including them.

Claims

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

an elongate body;

a central lumen extending within the elongate body from a proximal end of the elongate body to a distal end of the elongate body;

a rotatable tip at the distal end of the elongate body and configured to rotate in a first direction and a second direction relative to the elongate body;

an optical coherence tomography (OCT) imaging sensor comprising an optical fiber coupled with the rotatable tip and configured to rotate therewith, wherein the optical fiber is configured to wrap around the central lumen within the elongate body as the rotatable tip rotates; and

a drive mechanism configured to continuously and automatically alternate rotation of the rotatable tip between the first direction and the second direction a plurality of times, each rotation in the first and second direction including a substantially equivalent number of turns.

2. The device of claim 1, wherein the drive mechanism is configured to rotate the rotatable tip at between about 1 and about 100 rpm.

3. The device of claim 1, wherein each rotation in the first and second direction includes less than 25 turns.

4. The device of claim 1, wherein the rotatable tip comprises a helical blade edge.

5. The device of claim 1, wherein the rotatable tip comprises a substantially smooth, curved outer surface that presents an atraumatic tissue-contacting surface when rotated in the first direction and that presents a dissecting surface when rotated in the second direction.

6. The device of claim 1, wherein the elongate body includes a fixed jog near the distal end configured to aid in steering the catheter device.

7. The device of claim 1, wherein the elongate body includes at least one marker configured to obstruct imaging from the OCT sensor at least once per rotation of the rotatable tip.

8. The device of claim 7, wherein the elongate body further comprises a fixed jog near the rotatable tip, and wherein the fixed jog is in a fixed orientation relative to the at least one marker to aid in steering the device.

9. The device of claim 1, further comprising a marker on the elongate body visible by fluoroscopy that does not obstruct imaging from the OCT sensor.

10. The device of claim 9, further comprising a controller, the controller configured to align an OCT image generated from the OCT sensor with the fluoroscopy image using the marker.

11. The device of claim 1, further comprising a flush port having an opening near the rotatable tip.

12. The device of claim 11, wherein the opening is less than 2 mm from the imaging sensor.

13. The device of claim 1, wherein the central lumen extends through a driveshaft, the driveshaft configured to rotate the rotatable tip.

14. The device of claim 1, wherein a distal end of the rotatable tip is less than 3 mm from the imaging sensor.

15. A method of crossing 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 central lumen extending within the elongate body from a proximal end of the elongate body to 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 and the optical fiber wraps around the central lumen within the elongate body;

automatically rotating the rotatable tip a substantially equivalent number of rotations in a second direction relative to the elongate body;

repeating the rotating steps such that the tip is continuously and automatically alternated between rotating in the first direction and the second direction;

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

passing the rotatable distal tip past an occlusion in the body lumen.

16. The method of claim 15, further comprising rotating the catheter within the body lumen.

17. The method of claim 15, further comprising advancing a guidewire past the occlusion by passing the guidewire through a central lumen within the elongate body of the occlusion crossing catheter.

18. The method of claim 15, further comprising advancing the catheter while rotating the rotatable tip to separate tissue in the lumen.

19. The method of claim 15, further comprising flushing a fluid through a fluid port near the OCT sensor.

20. The method of claim 19, wherein less than 1 mL of fluid is flushed through the port.

21. The method of claim 15, further comprising orienting image data taken with the OCT sensor to align with a fluoroscopy image.

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

an elongate body;

a central lumen extending within the elongate body from a proximal end of the elongate body to a distal end of the elongate body;

a rotatable tip at the distal end of the elongate body and configured to rotate in a first direction and a second direction relative to the elongate body, wherein the rotatable tip comprises a substantially smooth, curved outer surface that presents an atraumatic tissue-contacting surface when rotated in the first direction and that presents a dissecting surface when rotated in the second direction;

an optical coherence tomography (OCT) imaging sensor comprising an optical fiber coupled with the rotatable tip and configured to rotate therewith, wherein the optical fiber is configured to wrap around the central lumen within the elongate body as the rotatable tip rotates; and

a drive mechanism configured to continuously and automatically alternate between rotating the rotatable tip a substantially equivalent number of rotations in the first direction and the second direction.

23. The device of claim 22, wherein the drive mechanism is configured to rotate the rotatable tip at between about 1 and about 100 rpm.

24. The device of claim 22, wherein each substantially equivalent number of rotations is less than 25 rotations.

25. The device of claim 22, wherein the elongate body includes at least one marker configured to obstruct imaging from the OCT sensor at least once per rotation of the rotatable tip.

26. The device of claim 25, wherein the elongate body further comprises a fixed jog near the rotatable tip, and wherein the fixed jog is in a fixed orientation relative to the at least one marker to aid in steering the device.

27. The device of claim 22, further comprising a marker on the elongate body visible by fluoroscopy that does not obstruct imaging from the OCT sensor.

28. The device of claim 27, further comprising a controller, the controller configured to align an OCT image generated from the OCT sensor with the fluoroscopy image using the marker.