# US 10,117,659 B2 · Subintimal re-entry catheter with actuatable orientation mechanism

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- Number: US 10,117,659 B2
- Document ID: US10117659B2
- Status: Granted
- Kind: B2
- Application number: 15/250,075
- Filed: 2016-08-29
- Published: 2016-12-15
- Granted: 2018-11-06
- Earliest claimed: 2013-01-15
- Assignees: Boston Scientific Scimed, Inc.
- Applicants: Boston Scientific Scimed, Inc.
- Inventors: Pu Zhou; Huisun Wang
- Web page: https://patentgrep.com/patent/US10117659B2

## CPC

- A61B 17/22: Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B 17/3207: Atherectomy devices {working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions (A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016)}
- A61B 17/3478: {Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067)}
- A61M 25/0071: {Multiple separate lumens (multiple separate lumens throughout the catheter A61M25/0026)}
- A61M 25/0074: {Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable}
- A61M 25/0108: {using radio-opaque or ultrasound markers}
- A61M 25/0169: {Exchanging a catheter while keeping the guidewire in place}
- A61B 2017/22044: {with a pointed tip}
- A61B 2017/22095: {accessing a blood vessel true lumen from the sub-intimal space}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- 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 recanalization catheter for facilitating re-entry into a lumen of a blood vessel from a subintimal space. The recanalization catheter includes first and second mechanically actuatable wings positioned at a distal region of the elongate shaft of the catheter that are actuatable between a retracted position and an expanded position. In the retracted position the mechanically actuatable wings are positioned in first and second elongate channels defined in the elongate shaft, and in the expanded position the mechanically actuatable wings extend outward from the first and second elongate channels. The actuatable wings extend in an arcuate path away from the elongate shaft in the expanded position to be positionable in a circumferential orientation within a subintimal space formed in a vessel wall to automatically orient a lateral port of the elongate shaft toward the true lumen.

## Claims

### Claim 1

A recanalization catheter for facilitating re-entry into a lumen of a blood vessel from a subintimal space, comprising:
an elongate shaft extending distally from a hub assembly, the elongate shaft including a guidewire lumen extending along a longitudinal axis of the elongate shaft;
first and second actuatable wings positioned at a distal region of the elongate shaft, the first and second actuatable wings being actuatable between a retracted position and an expanded position;
the elongate shaft including a lateral port positioned between the first and second actuatable wings;
wherein in the expanded position the first and second actuatable wings extend radially outward on opposite sides of the elongate shaft along an arcuate path;
wherein in the expanded position, an outermost extent of the first actuatable wing curves toward a first plane extending through and parallel to the longitudinal axis which passes through the lateral port and away from a second plane extending perpendicular to the first plane;
wherein in the expanded position, an outermost extent of the second actuatable wing curves toward the first plane and away from the second plane; and
wherein the first actuatable wing extends outward from a first channel in the elongate shaft and the second actuatable wing extends outward from a second channel in the elongate shaft.

### Claim 2 (depends on 1)

The recanalization catheter of claim 1, wherein the distal region of the elongate shaft has an outer periphery, wherein in the retracted position the first and second actuatable wings are positioned radially inward of the outer periphery of the elongate shaft and in the expanded position the first and second actuatable wings are positioned radially outward of the outer periphery of the elongate shaft.

### Claim 3 (depends on 1)

The recanalization catheter of claim 1, wherein the first and second actuatable wings are configured to orient the lateral port toward the lumen of the blood vessel when the first and second actuatable wings are in the expanded position in the subintimal space.

### Claim 4 (depends on 1)

The recanalization catheter of claim 1, wherein the lateral port is in communication with the guidewire lumen.

### Claim 5 (depends on 1)

The recanalization catheter of claim 1, further comprising an actuator on the hub assembly configured to actuate the first and second actuatable wings from the retracted position to the expanded position.

### Claim 6 (depends on 1)

The recanalization catheter of claim 1, wherein the lateral port is located between proximal and distal extents of the first and second actuatable wings.

### Claim 7 (depends on 1)

The recanalization catheter of claim 1, wherein a distal end of the first actuatable wing is secured to the elongate shaft, and a distal end of the second actuatable wing is secured to the elongate shaft.

### Claim 8 (depends on 1)

The recanalization catheter of claim 1, wherein the first and second actuatable wings have a preset circumferential curvature such that the first and second actuatable wings automatically curve from the elongate shaft when actuated to the expanded position.

### Claim 9 (depends on 1)

The recanalization catheter of claim 1, further comprising a re-entry device extendable from the lateral port into the lumen of the blood vessel.

### Claim 10 (depends on 1)

The recanalization catheter of claim 1, wherein the first actuatable wing is formed of a distal portion of a first wire extending through the elongate shaft and the second actuatable wing is formed of a distal portion of a second wire extending through the elongate shaft.

### Claim 11 (depends on 10)

The recanalization catheter of claim 10, wherein the first and second wires extend to an actuator on the hub assembly.

### Claim 12

A recanalization catheter for facilitating re-entry into a lumen of a blood vessel from a subintimal space, comprising:
an elongate shaft extending distally from a hub assembly, the elongate shaft including a guidewire lumen extending along a longitudinal axis of the elongate shaft and a lateral port extending through a wall of the elongate shaft to the guidewire lumen;
first and second actuatable wings positioned on opposite sides of the elongate shaft with distal ends of each of the first and second actuatable wings secured to the elongate shaft, the first and second actuatable wings being actuatable between a retracted position and an expanded position;
wherein in the expanded position the first and second actuatable wings extend radially outward on opposite sides of the elongate shaft along a circumferentially arcuate path;
wherein in the expanded position, an outermost extent of the first actuatable wing circumferentially curves toward a first plane extending through and parallel to the longitudinal axis which passes through the lateral port and away from a second plane extending perpendicular to the first plane;
wherein in the expanded position, an outermost extent of the second actuatable wing circumferentially curves toward the first plane and away from the second plane; and
wherein the first actuatable wing extends outward from a first channel in the elongate shaft and the second actuatable wing extends outward from a second channel in the elongate shaft.

### Claim 13 (depends on 12)

The recanalization catheter of claim 12, wherein the first actuatable wing is formed of a distal portion of a first wire extending through the elongate shaft and the second actuatable wing is formed of a distal portion of a second wire extending through the elongate shaft.

### Claim 14 (depends on 13)

The recanalization catheter of claim 13, wherein the first and second wires extend to an actuator on the hub assembly.

### Claim 15 (depends on 13)

The recanalization catheter of claim 13, wherein the first wire extends through a first auxiliary lumen extending through the elongate shaft and the second wire extends through a second auxiliary lumen extending through the elongate shaft.

### Claim 16 (depends on 15)

The recanalization catheter of claim 15, wherein the first and second wires extend to an actuator on the hub assembly.

### Claim 17 (depends on 15)

The recanalization catheter of claim 15, wherein the guidewire lumen is positioned longitudinally between the first and second auxiliary lumens.

### Claim 18 (depends on 12)

The recanalization catheter of claim 12, wherein the first and second actuatable wings are configured to orient the lateral port toward the lumen of the blood vessel when the first and second actuatable wings are in the expanded position in the subintimal space.
