# US 10,869,685 B2 · Catheter system and method for boring through blocked vascular passages

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- Number: US 10,869,685 B2
- Document ID: US10869685B2
- Status: Granted
- Kind: B2
- Application number: 15/922,058
- Filed: 2018-03-15
- Published: 2018-09-13
- Granted: 2020-12-22
- Earliest claimed: 2008-04-23
- Assignees: Avinger, Inc.
- Applicants: Avinger, Inc.
- Inventors: Himanshu N. Patel; John B. Simpson
- Web page: https://patentgrep.com/patent/US10869685B2

## CPC

- A61B 17/32002: {with continuously rotating, oscillating or reciprocating cutting instruments}
- 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 17/22012: {in direct contact with, or very close to, the obstruction or concrement (for removing obstructions in blood vessels by laser A61B18/245)}
- A61B 17/32075: {Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 18/24: with a catheter (A61B18/26, A61B18/28 take precedence)
- A61B 2017/00336: {with a protective sleeve, e.g. retractable or slidable}
- A61B 2017/00398: {using powered actuators, e.g. stepper motors, solenoids}
- A61B 2017/22094: {for crossing total occlusions, i.e. piercing}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A rotating cutting head catheter for passage through chronic total occlusions or other refractory atherosclerotic plaque from diseased arteries is disclosed. The catheter's rotating cutting head is designed to reside safely within an outer protective sheath when not in use. The outer protective sheath contains one or more helical grooves or slots, and the cutting head contains protruding blades or projections that fit into these helical grooves or slots. Application of torque to an inner catheter or wire attached to the cutting head applies spin to the cutting head, and the force of the sheath's helical grooves or slots against the cutting head's protruding blades or projections advances the cutting head outward from the protective sheath. Once extended, the cutting head may now rotate freely. The device may use a guidewire to direct the cutting head to the desired position.

## Claims

### Claim 1

A method of delivering a guidewire across an occlusion in a vascular lumen, the method comprising:
passing a distal end of a catheter through the vascular lumen to the occlusion, wherein the catheter comprises an elongate catheter body and a cutting head having a blade and a protective housing, the protective housing having a slot therein;
positioning the cutting head in a cutting configuration by extending the blade through the slot;
rotating the cutting head relative to the protective housing in the cutting configuration to advance the cutting head across the lesion;
positioning the cutting head in a stowed configuration by retracting the blade into the protective housing through the slot; and
passing a guidewire through a guidewire passageway extending through the catheter body and cutting head such that the guidewire spans the occlusion.

### Claim 2 (depends on 1)

The method of claim 1, wherein rotating the cutting head in the cutting configuration comprises rotating the cutting head both clockwise and counterclockwise.

### Claim 3 (depends on 2)

The method of claim 2, wherein rotating the cutting head in the cutting configuration in the clockwise direction provides a different mode of aggressiveness relative to rotating the cutting head in the cutting configuration in the counterclockwise direction.

### Claim 4 (depends on 1)

The method of claim 1, further comprising using the guidewire spanning the occlusion to treat the occlusion by atherectomy, stenting, or balloon angioplasty.

### Claim 5 (depends on 1)

The method of claim 1, further comprising applying torque to a torque communicating connector connected to the cutting head to extend the cutting head from the stowed configuration to the cutting configuration.

### Claim 6 (depends on 1)

The method of claim 1, wherein passing a distal end of a catheter through the vascular lumen to the occlusion comprises passing the distal end through the vascular lumen while the blade is in the stowed configuration.

### Claim 7 (depends on 1)

The method of claim 1, wherein the cutting head is in the cutting configuration only for as much as time as is needed to cut through the occlusion.

### Claim 8 (depends on 1)

The method of claim 1, further comprising repeating the steps of positioning the cutting head in a cutting configuration rotating the cutting head in the cutting configuration, and positioning the cutting head in a stowed configuration.

### Claim 9 (depends on 1)

The method of claim 1, wherein the blade is curved and the slot is curved.

### Claim 10 (depends on 1)

The method of claim 1, wherein the cutting head in the stowed configuration is fully retracted into and covered by the protective housing.

### Claim 11 (depends on 1)

The method of claim 1, wherein positioning the cutting head in a cutting configuration comprises rotating the cutter relative to the protective housing to extend the blade through the slot.

### Claim 12

A method of delivering a guidewire across an occlusion in a vascular lumen, the method comprising:
passing a distal end of a catheter through the vascular lumen to the occlusion, wherein the catheter comprises an elongate catheter body and a cutting head having a blade and a protective housing, the protective housing having a slot therein, wherein the blade is curved and the slot is curved;
positioning the cutting head in a cutting configuration by extending the blade through the slot;
rotating the cutting head in the cutting configuration to advance the cutting head across the lesion;
positioning the cutting head in a stowed configuration by retracting the blade into the protective housing through the slot; and
passing a guidewire through a guidewire passageway extending through the catheter body and cutting head such that the guidewire spans the occlusion.
