Atherectomy catheters devices having multi-channel bushings

• US 10,568,655 B2
• Filed: 03/13/2017
• Issued: 02/25/2020
• Est. Priority Date: 02/06/2014
• Status: Active Grant

• Current Assignee: Avinger Inc.
• Original Assignee: Avinger Inc.
• Inventors: Simpson, John B., Patel, Himanshu N., Fernandez, Anthony J., Newhauser, Richard R.
• Primary Examiner(s): Shi, Katherine M
• Application Number:
  US15/457,960
• Publication Number:
  US 20170273711A1
• Time in Patent Office: 1,079 Days
• Field of Search: 606159, 604 22
• 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 2017/320791 with cutter extending outside the cutting window
• CPC Class Codes: A61B 2090/3735 Optical coherence tomography [OCT]
• 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: A61M 25/0043 characterised by structural features
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool

Abstract

Atherectomy catheters and methods of using them are described herein. In particular, described herein are optical coherence tomography (OCT) catheters that may include a distal tip that can be deflected away from the long axis of the device using a multi-channel bushing. The bushing may include at a hinge point that is offset (e.g., located on a side of the elongate body near the distal end of the elongate body) and a rotatable cutter near an imaging assembly that can be driven against the wall with a high mechanical advantage.

Claims

1. An atherectomy catheter device, the device comprising:

an elongate body;

a hollow distal tip extending from a distal end of the elongate body;

a drive shaft extending proximally to distally within the elongate body;

a bushing coupled to the hollow distal tip, the bushing having a hinge point connecting the bushing to the elongate body and an inner flange positioned distal to the hinge point; and

a cutting and imaging assembly coupled to the drive shaft, the cutting and imaging assembly having a distal cutting edge and a neck region that passes through the bushing;

wherein the bushing is configured such that distal movement of the drive shaft within the bushing causes the inner flange to move along the neck region of the cutting and imaging assembly, rotating the hollow distal tip and bushing about the hinge point and axially aligning the hollow distal tip with the elongate body to at least partially cover the distal cutting edge

further wherein the bushing has a distal end face that is angled at greater than 90 degrees relative to a central longitudinal axis of the elongate body, and wherein the bushing is configured such that proximal movement of the drive shaft within the bushing causes a proximal surface of the cutting and imaging assembly to slide along at least a portion of the distal end of the bushing, pivoting the bushing and the hollow tip about the hinge point and exposing the distal cutting edge.

2. The device of claim 1, wherein the bushing further comprises a first channel therethrough and a second channel extending at an angle relative to the first channel, wherein the second channel overlaps with the first channel, and wherein the neck region sits within the first channel when the hollow distal tip is aligned with the elongate body and through the second channel when the hollow distal tip is angled relative to the elongate body.

3. The device of claim 2, wherein the bushing comprises a hinge channel formed through a top peripheral region of the bushing, further wherein the hinge channel extends in a direction that is transverse to the first channel.

4. The device of claim 1, wherein the hinge point is off-axis relative to a central longitudinal axis of the elongate body.

5. The device of claim 1, wherein the hinge point is one of a pair of hinge points that are on either side of the bushing body and offset rom a midline along a distal-to-proximal axis of the bushing body.

6. The device of claim 1, further comprising an optical fiber extending though the drive shaft and coupled to a reflector in the cutting and imaging assembly to form an optical coherence tomography (OCT) imaging sensor.

7. The device of claim 1, wherein the cutting and imaging assembly is configured to rotate within the bushing.

8. The device of claim 1, wherein the cutting and imaging assembly is configured to extend beyond the bushing and into the hollow distal tip to pack tissue into the hollow distal tip.

9. An atherectomy catheter device, the device comprising:

an elongate body;

a hollow distal tip extending from a distal end of the elongate body;

a drive shaft extending distally to proximally within the elongate body;

a cutting and imaging assembly coupled to the drive shaft, the cutting and imaging assembly having a distal cutting edge and a proximal surface; and

a bushing coupled to the hollow distal tip, the bushing having a hinge point connecting the bushing to the elongate body and a distal face that is angled relative to the proximal surface of the cutting and imaging assembly such that the only point of contact between the proximal surface and the distal face is an inner distal edge of the bushing; and

wherein proximal movement of the drive shaft within the bushing causes the proximal surface of the cutting and imaging assembly to slide along the inner distal edge of the bushing to pivot the bushing and hollow distal tip about the hinge point to expose the distal cutting edge.

10. The device of claim 9, wherein the cutting and imaging assembly further comprises a necked region that passes through the bushing.

11. The device of claim 10, wherein the bushing further comprises a first channel through the bushing and a second channel extending at an angle relative to the first channel, wherein the second channel overlaps with the first channel, and wherein the neck region sits within the first channel when the hollow distal tip is aligned with the elongate body and through the second channel when the hollow distal tip is angled relative to the elongate body.

12. The device of claim 9, wherein the distal face is at an angle of less than 90 degrees relative to a central longitudinal axis of the elongate body.

13. The device of claim 9, further comprising an optical fiber extending though the drive shaft and coupled to a reflector in the cutting and imaging assembly to form an optical coherence tomography (OCT) imaging sensor.

14. The device of claim 9, wherein the cutting and imaging assembly is configured to rotate within the bushing.

15. The device of claim 9, wherein the bushing has an inner flange positioned distal to the hinge point, wherein the cutting and imaging assembly has a neck region that passes through the bushing, and wherein the bushing is configured such that distal movement of the drive shaft within the bushing causes the inner flange to move along the neck region of the cutting and imaging assembly, rotating the hollow distal tip and bushing about the hinge point and axially aligning the hollow distal tip with the elongate body to at least partially cover the distal cutting edge.