# US 2021/0330345 A1 · Occlusion-crossing devices

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- Number: US 2021/0330345 A1
- Document ID: US20210330345A1
- Status: Published application
- Kind: A1
- Application number: 17/209,168
- Filed: 2021-03-22
- Published: 2021-10-28
- Earliest claimed: 2011-03-28
- Assignees: Avinger, Inc.
- Applicants: Avinger, Inc.
- Inventors: Richard R. NEWHAUSER; Theodore W. KETAI; Peter H. SMITH; Myra L. FABRO
- Web page: https://patentgrep.com/patent/US20210330345A1

## CPC

- 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)}
- A61B 17/320783: {through side-hole, e.g. sliding or rotating cutter inside catheter}
- A61B 2017/003: {Steerable}
- A61B 2017/00336: {with a protective sleeve, e.g. retractable or slidable}
- A61B 2017/00398: {using powered actuators, e.g. stepper motors, solenoids}
- A61B 2017/320004: {abrasive}
- A61B 2017/320052: {Guides for cutting instruments}
- A61B 2017/320056: {Tunnelers}
- A61B 2090/3735: {Optical coherence tomography [OCT]}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A catheter device for crossing occlusions includes an elongate catheter shaft, a rotatable tip configured to rotate relative to the elongate catheter shaft, a drive shaft, and an OCT imaging sensor. The rotatable tip includes a housing coupled with the elongate catheter shaft and cutting wedges extendable from the housing. The drive shaft has a central lumen extending therethrough and extends within the elongate catheter shaft. The drive shaft is coupled with the wedges and is configured to rotate the rotatable tip. The OCT sensor includes an optical fiber coupled with the rotatable tip and configured to rotate therewith. The elongate catheter shaft is configured to move axially over the drive shaft to extend and retract the wedges from the housing while maintaining a fixed position of the imaging sensor relative to the cutting wedges.

## Claims

### Claim 1

(canceled)

### Claim 2

A catheter device for crossing occlusions, the catheter device comprising:
an elongate catheter shaft;
a rotatable tip configured to rotate relative to the elongate catheter shaft, wherein the rotatable tip comprises at least one grinding outer surface, the grinding outer surface comprising a plurality of divots and sharp points therein;
a drive shaft extending within the elongate catheter shaft and configured to rotate the rotatable tip; and
an OCT imaging sensor comprising an optical fiber coupled with the rotatable tip and configured to rotate therewith.

### Claim 3 (depends on 2)

The catheter device of claim 2, further comprising a plurality of flutes extending around a portion of a circumference of the rotatable tip between a proximal end of the rotatable tip and a distal end of the rotatable tip.

### Claim 4 (depends on 3)

The catheter device of claim 3, wherein a pitch of the plurality of flutes is greater than 0.10 inches.

### Claim 5 (depends on 3)

The catheter device of claim 3, wherein a portion of the rotatable tip along which the plurality of flutes extend is tapered so as to have a smaller diameter at a proximal end of the portion than a distal end of the portion.

### Claim 6 (depends on 3)

The catheter device of claim 3, wherein there are only 2-3 flutes in the plurality of flutes.

### Claim 7 (depends on 2)

The catheter device of claim 2, wherein the rotatable tip is configured to cut more aggressively when rotated in one direction than another.

### Claim 8 (depends on 2)

The rotatable tip of claim 2, wherein the rotatable tip further comprises a fiber channel along an outer surface thereof, the fiber channel configured to hold the optical fiber therein.

### Claim 9 (depends on 2)

The catheter device of claim 2, further comprising a guidewire lumen extending through the rotatable tip.

### Claim 10 (depends on 9)

The catheter device of claim 9, wherein the rotatable tip further comprises a countersink on a distal surface thereof, the countersink surrounding the guidewire lumen.

### Claim 11 (depends on 2)

The catheter device of claim 2, wherein the plurality of sharp points and divots are formed by an array of pyramidal features.

### Claim 12 (depends on 2)

The catheter device of claim 2, wherein the plurality of sharp points and divots are formed by an array of spirals.

### Claim 13 (depends on 2)

The catheter device of claim 2, wherein the plurality of sharp points and divots are configured to grind or slice through hard tissue as the rotatable tip is rotated.

### Claim 14 (depends on 2)

The catheter device of claim 2, wherein the rotatable tip is configured to rotate in a first direction until a set tension or resistance threshold is reached and then switch to rotate in a second direction.

### Claim 15 (depends on 2)

The catheter device of claim 2, wherein the optical fiber is embedded in a transparent or translucent medium within the rotatable tip.

### Claim 16 (depends on 15)

The catheter device of claim 15, wherein the optical fiber is loose within the elongate catheter shaft.

### Claim 17 (depends on 2)

The catheter device of claim 2, wherein the elongate catheter shaft is configured form a fixed bend proximal to the rotatable distal tip.

### Claim 18 (depends on 2)

The catheter device of claim 2, wherein the imaging sensor is positioned within 5 mm of a distal end of the rotatable tip.

### Claim 19 (depends on 2)

The catheter device of claim 2, wherein the imaging sensor is configured to image laterally.

### Claim 20 (depends on 2)

The catheter device of claim 2, further comprising a chassis that is fixed relative to the elongate catheter shaft, the chassis configured to enable the rotatable distal tip to rotate relative to the elongate catheter shaft.

### Claim 21 (depends on 20)

The catheter device of claim 20, wherein the chassis comprises a plurality of window regions therein configured to enable the imaging sensor to image therethrough.
