# US 11,076,773 B2 · Guidewire positioning catheter

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- Number: US 11,076,773 B2
- Document ID: US11076773B2
- Status: Granted
- Kind: B2
- Application number: 15/480,238
- Filed: 2017-04-05
- Published: 2018-02-15
- Granted: 2021-08-03
- Earliest claimed: 2009-04-28
- Assignees: Avinger, Inc.
- Applicants: Avinger, Inc.
- Inventors: Himanshu N. Patel; John B. Simpson
- Web page: https://patentgrep.com/patent/US11076773B2

## CPC

- A61B 5/066: {Superposing sensor position on an image of the patient, e.g. obtained by ultrasound or x-ray imaging}
- 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)}
- A61M 25/01: Introducing, guiding, advancing, emplacing or holding catheters (A61M25/10 takes precedence)
- A61M 25/0138: {having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils}
- A61B 2017/003: {Steerable}
- A61B 2017/00309: {Cut-outs or slits}
- A61B 2017/22038: {with a guide wire}
- A61B 2017/320775: {Morcellators, impeller or propeller like means}
- A61M 25/0147: {with movable mechanical means, e.g. pull wires}
- A61M 25/0155: {with hydraulic or pneumatic means, e.g. balloons or inflatable compartments}
- A61M 25/0172: {Exchanging a guidewire while keeping the catheter in place}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

A catheter for positioning a guidewire across an occluded portion of a vessel includes an elongate catheter body, an integrated rotatable distal tip, a proximal handle region, and a catheter lumen extending through the elongate catheter body. The elongate body has a distal region configured to be bent to a set angle. The integrated rotatable distal tip includes one or more channeled flutes extending around the distal tip that are configured to be rotated in a first direction to dissect tissue and a second direction for bluntly contacting tissue. A proximal handle region includes a control for rotating the distal tip in either the first or second directions. The catheter lumen is configured to pass a guidewire.

## Claims

### Claim 1

A catheter device for positioning a guidewire across an occluded portion of a vessel, the catheter device comprising:
an elongate catheter body having a central lumen and a steerable distal end, the steerable distal end comprising a scaffold including a narrow solid band that extends longitudinally along the elongate catheter body;
a rotatable distal tip comprising one or more channeled flutes extending around the rotatable distal tip so as to form a plurality of cutting edges, wherein the steerable distal end is configured to controllably deflect the rotatable distal tip;
a driveshaft extending within the central lumen of the elongate catheter body and configured to rotate the rotatable distal tip, the driveshaft configured to move longitudinally in a distal direction relative to the elongate catheter body to cause at least a portion of the rotatable distal tip to extend from a protected position inside the elongate catheter body to an exposed position outside of the elongate catheter body, wherein a force applied to the driveshaft in the distal direction relative to the elongate catheter body causes the elongate catheter body to bend toward the narrow solid band and to activate the steerable distal end; and
a proximal handle region including a control for rotating the driveshaft and distal tip in a forward direction to cut tissue with the plurality of cutting edges and in a reverse direction to bluntly contact tissue.

### Claim 2 (depends on 1)

The catheter device of claim 1, wherein an outer diameter of the rotatable distal tip is the same as an outer diameter of the elongate catheter body.

### Claim 3 (depends on 1)

The catheter device of claim 1, wherein the plurality of cutting edges are part of one or more helical cutting edges.

### Claim 4 (depends on 1)

The catheter device of claim 1, further comprising a second control on the proximal handle region configured to deflect the steerable distal end.

### Claim 5 (depends on 1)

The catheter device of claim 1, wherein the driveshaft comprises a braided shaft.

### Claim 6 (depends on 1)

The catheter device of claim 1, further comprising a seal positioned between the driveshaft and the elongate catheter body.

### Claim 7 (depends on 1)

The catheter device of claim 1, wherein the proximal handle region further includes a luer connector thereon configured to provide access to the central lumen for fluid flush and entry of the guidewire.

### Claim 8 (depends on 7)

The catheter device of claim 7, wherein the luer connector includes a threaded or lockable region.

### Claim 9 (depends on 7)

The catheter device of claim 7, wherein the luer connector includes a flanged opening.

### Claim 10 (depends on 1)

The catheter device of claim 1, wherein the rotatable distal tip is configured to self-center the catheter device within a true lumen of the vessel.

### Claim 11 (depends on 1)

The catheter device of claim 1, wherein the scaffold further comprises a plurality of slits in a region neighboring the narrow solid band.

### Claim 12 (depends on 11)

The catheter device of claim 11, wherein the plurality of slits extend substantially transverse to a longitudinal axis of the catheter device.

### Claim 13 (depends on 11)

The catheter device of claim 11, wherein the plurality of slits form a zig-zag pattern.

### Claim 14 (depends on 1)

The catheter device of claim 1, wherein the narrow solid band extends longitudinally along a first side of the elongate catheter body, wherein the narrow solid band is configured to bend such that a second side of the scaffold opposite the first side expands.

### Claim 15 (depends on 14)

The catheter device of claim 14, wherein the second side of the scaffold includes a cut region, wherein expansion of the second side causes spacings of the cut region to expand.

### Claim 16 (depends on 1)

The catheter device of claim 1, wherein a proximal end of the scaffold is fixedly connected to the elongate catheter body.

### Claim 17 (depends on 1)

The catheter device of claim 1, wherein the driveshaft is further configured to move longitudinally in a proximal direction relative to the elongate catheter body to cause the rotatable distal tip to retract from the exposed position outside of the elongate catheter body to the protected position inside the elongate catheter body.

### Claim 18 (depends on 1)

The catheter device of claim 1, wherein the proximal handle region includes a slider that is configured to move a first distance to cause the at least a portion of the rotatable distal tip to extend to the exposed position and to move a second distance to cause the elongate catheter body to bend.
