Atherectomy catheters devices having multi-channel bushings

• US 9,592,075 B2
• Filed: 03/16/2016
• Issued: 03/14/2017
• Est. Priority Date: 02/06/2014
• Status: Active Grant

• Current Assignee: Avinger Inc.
• Original Assignee: Avinger Inc.
• Inventors: Fernandez, Anthony J., Simpson, John B., Patel, Himanshu N., Newhauser, Richard R.
• Primary Examiner(s): SHI, KATHERINE MENGLIN
• Application Number:
  US15/072,272
• Publication Number:
  US 20160192962A1
• Time in Patent Office: 363 Days
• Field of Search: 606/159, 604/22
• US Class Current: 1/1
• 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 having a multi-channeled bushing, the device comprising:

an elongate body;

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

a drive shaft extending within the elongate body;

a bushing comprising

a bushing body,

a hinge point on a side of the bushing body,

a first channel extending proximally to distally through the bushing body,

a second channel extending proximally to distally through the bushing body, overlapping with the first channel and having a diameter of the second channel that is less than a diameter of the first channel, and wherein the second channel is angled between 1° and

45°

relative to the first channel,

a first opening at a distal end of the bushing body into the first channel, and

a second opening at the distal end of the bushing body into the second channel, wherein the first and second openings overlap; and

a cutter having a distal cutting head with a cutting edge, an elongate cylindrical body, and a neck region extending between the distal cutting edge and the elongate cylindrical body, wherein the drive shaft is coupled to the elongate cylindrical body;

further wherein distal movement of the drive shaft extends the cylindrical body of the cutter within the first channel of the bushing and drives the tip about the hinge point to axially align the tip with the elongate body and at least partially cover the cutting edge, while proximal movement of the drive shaft extends the neck region of the cutter within the second channel of the bushing and drives the tip about the hinge point to angle the tip relative to the elongate body and at least partially expose the cutting edge.

2. The device of claim 1, wherein the bushing comprises an inner flange positioned distal to the hinge, wherein distal movement of the drive shaft extends the cylindrical body of the cutter within the first channel of the bushing and drives the neck region against the inner flange portion to drive the tip about the hinge point to axially align the tip with the elongate body.

3. The device of claim 1, wherein the bushing comprises an outer flange at the distal end of the bushing, wherein proximal movement of the drive shaft extends the neck region of the cutter within the second channel of the bushing and drives the distal cutting head against the outer flange portion to drive the tip about the hinge point to angle the tip relative to the elongate body.

4. The device of claim 1, wherein the bushing comprises an outer flange at the distal end of the bushing, wherein proximal movement of the drive shaft extends the neck region of the cutter within the second channel of the bushing and drives the distal cutting head against the outer flange portion to drive the tip about the hinge point to angle the tip relative to the elongate body, further wherein the outer flange at the distal end of the bushing comprises a face that is angled relative to a central longitudinal axis of the elongate body.

5. The device of claim 1, wherein the second channel is angled between about 2°

and 15°

relative to the first channel.

6. 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 from a midline along a distal-to-proximal axis of the bushing body.

7. The device of claim 1, wherein the hinge point is part of a hinge channel formed through a top peripheral region of the bushing body, further wherein the hinge channel extends in a direction that is transverse to the first channel.

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

9. The device of claim 1, wherein the cutter is configured to rotate within the bushing.

10. The device of claim 1, wherein the elongate cylindrical body of the cutter is configured to rotate within the bushing.

11. The device of claim 1, wherein the tip comprises a hollow tip.

12. The device of claim 1, wherein the cutter is configured to extend beyond the bushing and into the tip to pack tissue into the tip.

13. An atherectomy catheter device having a multi-channeled bushing, the device comprising:

an elongate body;

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

a drive shaft extending within the elongate body;

a bushing comprising

a bushing body,

a pair of hinge points on either side of the bushing body that are offset from a midline along a distal-to-proximal axis of the bushing body,

an inner flange positioned distal to the hinge points

a first channel extending proximally to distally through the bushing body,

a second channel extending proximally to distally through the bushing body and having a diameter along a length of the second channel that is less than a diameter along a length of the first channel, and wherein the first and the second channels overlap, and wherein the second channel is angled between 1° and

45°

relative to the first channel,

a first opening at a distal end of the bushing body into the first channel, and

a second opening at a distal end of the bushing body into the second channel, wherein the first and second openings overlap, and

an outer flange portion distal to the inner flange portion;

a cutter having a distal cutting head with a cutting edge, an elongate cylindrical body, and a neck region extending between the distal cutting edge and the elongate cylindrical body, wherein the drive shaft is coupled to the elongate cylindrical body; and

further wherein distal movement of the drive shaft extends the cylindrical body of the cutter within the first channel of the bushing, drives the neck region against the inner flange portion and drives the tip about the hinge points to axially align the tip with the elongate body at least partially covering the cutting edge, while proximal movement of the drive shaft extends the neck region of the cutter within the second channel of the bushing, drives the distal cutting head against the outer flange portion, and drives the tip about the hinge points to angle the tip relative to the elongate body and at least partially expose the cutting edge.

14. The device of claim 13, wherein the outer flange comprises a distal face at an angle of less than 90 degrees relative to a central longitudinal axis of the elongate body.

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

16. The device of claim 13, wherein the cutter is configured to rotate within the bushing.

17. The device of claim 13, wherein the cutter is configured to extend beyond the bushing and into the tip to pack tissue into the tip.

18. The device of claim 13, wherein the second channel is angled between about 2°

and 15°

relative to the first channel.

19. The device of claim 13, wherein the hinge points form a channel through a top peripheral region of the bushing body, further wherein the hinge channel extends in a direction that is transverse to the first channel.

20. An atherectomy catheter device having a multi-channeled bushing, the device comprising:

an elongate body;

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

a drive shaft extending within the elongate body;

a bushing comprising

a bushing body,

a pair of hinge points on either side of the bushing body that are offset from a midline along a distal-to-proximal axis of the bushing body,

an inner flange positioned distal to the hinge points

a first channel extending proximally to distally through the bushing body,

a second channel extending proximally to distally through the bushing body and having a diameter along a length of the second channel that is less than a diameter along a length of the first channel, and wherein the first and the second channels overlap, and wherein the second channel is angled between 1° and

45°

relative to the first channel,

a first opening at a distal end of the bushing body into the first channel, and

a second opening at a distal end of the bushing body into the second channel, wherein the first and second openings overlap, and

an outer flange portion distal to the inner flange portion; and

a cutter having a distal cutting head with a cutting edge, an elongate cylindrical body, and a neck region extending between the distal cutting edge and the elongate cylindrical body, wherein the drive shaft is coupled to the elongate cylindrical body;

further wherein distal movement of the drive shaft extends the cylindrical body of the cutter within the first channel of the bushing and drives the hollow distal tip about the hinge points to axially align the hollow distal tip with the elongate body at least partially covering the cutting edge, while proximal movement of the drive shaft extends the neck region of the cutter within the second channel of the bushing and drives the hollow distal tip about the hinge points to angle the hollow distal tip relative to the elongate body and at least partially expose the cutting edge.