Occlusion-crossing devices, imaging, and atherectomy devices

• US 9,572,492 B2
• Filed: 02/03/2014
• Issued: 02/21/2017
• Est. Priority Date: 04/23/2008
• 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:
  US14/171,583
• Publication Number:
  US 20140213893A1
• Time in Patent Office: 1,114 Days
• Field of Search: None
• US Class Current: 1/1
• 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

A catheter device for crossing occlusions includes an elongate body, a central lumen extending within the elongate body from the proximal end to the distal end, a rotatable tip at the distal end of the elongate body, and an OCT imaging sensor. The rotatable tip is configured to rotate relative to the elongate body. The OCT imaging sensor includes an optical fiber coupled with the rotatable tip and configured to rotate therewith. A distal end of the elongate body includes one or more markers configured to occlude the OCT imaging sensor as it rotates. A fixed jog in the elongate body proximal to the distal end of the catheter positions the distal end of the catheter at an angle relative to the region of the catheter proximal to the fixed jog and is aligned with the one or more markers on the elongate body.

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 relative to the elongate body;

an OCT imaging sensor comprising an optical fiber, the OCT imaging sensor coupled with the rotatable tip and configured to rotate therewith, wherein the elongate body comprises one or more markers configured to occlude the OCT imaging sensor as the OCT imaging sensor rotates; and

a bent or bendable region in the elongate body, the bent or bendable region forming or configured to form a fixed jog to point the distal end of the elongate body in a set direction, and wherein the one or more markers on the elongate body are in a predetermined circumferential position relative to the set direction so as to indicate an orientation of the distal end of the elongate body during OCT imaging.

2. The device of claim 1, wherein the fixed jog forms an angle of between about 10 to 45 degrees between the distal end of the elongate body and an area of the elongate body proximal to the fixed jog.

3. The device of claim 1, further comprising a drive mechanism configured to rotate the rotatable tip at between about 1 and about 100 rpm.

4. The device of claim 3, wherein the drive mechanism is configured to alternately rotate the rotatable tip in a first direction and a second direction.

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

6. 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.

7. The device of claim 1, further comprising a fluoroscopy marker on the elongate body, the fluoroscopy marker visible by fluoroscopy and configured so as to not obstruct imaging from the OCT imaging sensor.

8. The device of claim 7, further comprising a controller, the controller configured to align an OCT image generated from the OCT sensor with the fluoroscopy image using the fluoroscopy marker.

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

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