# US 11,298,511 B2 · Endovascular devices and methods for exploiting intramural space

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- Number: US 11,298,511 B2
- Document ID: US11298511B2
- Status: Granted
- Kind: B2
- Application number: 16/710,312
- Filed: 2019-12-11
- Published: 2020-04-09
- Granted: 2022-04-12
- Earliest claimed: 2006-11-21
- Assignees: BridgePoint Medical, Inc.
- Applicants: Bridgepoint Medical, Inc.
- Inventors: Chad J. Kugler; Matthew J. Olson; Ross A. Olson; David B. Robinson
- Web page: https://patentgrep.com/patent/US11298511B2

## CPC

- A61M 25/10: Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00})
- 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 17/221: Gripping devices in the form of loops or baskets {for gripping calculi or similar types of obstructions (surgical snare instruments A61B17/32056)}
- 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)}
- A61B 90/39: {Markers, e.g. radio-opaque or breast lesions markers}
- A61B 2017/00252: {for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel}
- A61B 2017/00778: {Operations on blood vessels (A61B2017/22097, A61B2017/320741 take precedence)}
- A61B 2017/22044: {with a pointed tip}
- A61B 2017/22048: {Balloons}
- A61B 2017/22054: {with two balloons}
- A61B 2017/22069: {Immobilising; Stabilising}
- A61B 2017/22071: {Steering}
- A61B 2017/22072: {with an instrument channel, e.g. for replacing one instrument by the other}
- A61B 2017/22094: {for crossing total occlusions, i.e. piercing}
- A61B 2017/22095: {accessing a blood vessel true lumen from the sub-intimal space}
- A61B 2017/320791: {with cutter extending outside the cutting window}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61M 25/1002: {characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence)}
- 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

The present disclosure is directed to a device. The device may include a distal shaft defining a central lumen and an orienting element comprising at least one inflatable member. Wherein a first portion of the orienting element extending from the shaft in a first direction and a second portion of the orienting element extending from the shaft in a second direction. Further, wherein the second direction is substantially opposite the first direction.

## Claims

### Claim 1

A method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein, comprising:
advancing a crossing device within the vascular lumen to a location proximal of the occlusion;
advancing a distal tip of the crossing device into the vascular wall;
advancing the crossing device distally between an intima of the vascular wall and an adventitia of the vascular wall until the distal tip of the crossing device is disposed at a location distal of the occlusion;
positioning a guidewire through a lumen of the crossing device to the location distal of the occlusion;
withdrawing the crossing device from the vascular wall while maintaining a position of the guidewire within the vascular wall;
advancing an orienting device over the guidewire and within the vascular wall until a first aperture of a shaft of the orienting device is disposed distal of the occlusion;
withdrawing the guidewire from the orienting device;
advancing a distal tip of a re-entry device through the orienting device and out the first aperture toward the vascular lumen distal of the occlusion.

### Claim 2 (depends on 1)

The method of claim 1, further comprising advancing the distal tip of the re-entry device through the intima of the vascular wall and into the vascular lumen distal of the occlusion.

### Claim 3 (depends on 1)

The method of claim 1, further comprising orienting the shaft of the orienting device between the intima and the adventitia of the vascular wall such that the first aperture is oriented toward the vascular lumen.

### Claim 4 (depends on 3)

The method of claim 3, wherein the step of orienting the shaft of the orienting device includes expanding an orienting element on a distal region of the shaft within the vascular wall.

### Claim 5 (depends on 4)

The method of claim 4, wherein the orienting element includes at least one inflatable member.

### Claim 6 (depends on 4)

The method of claim 4, wherein the orienting element includes first and second inflatable members extending in opposite directions from the shaft.

### Claim 7 (depends on 4)

The method of claim 4, wherein expanding the orienting element within the vascular wall causes the shaft to rotate about its central longitudinal axis.

### Claim 8 (depends on 1)

The method of claim 1, wherein the shaft of the orienting device further comprises a second aperture.

### Claim 9 (depends on 8)

The method of claim 8, wherein the second aperture is positioned on an opposite side of the shaft from the first aperture.

### Claim 10 (depends on 8)

The method of claim 8, wherein the second aperture is axially offset from the first aperture.

### Claim 11 (depends on 10)

The method of claim 10, wherein the first aperture is located proximal of the second aperture.

### Claim 12 (depends on 8)

The method of claim 8, further comprising orienting the shaft of the orienting device between the intima and the adventitia of the vascular wall such that the first aperture or the second aperture is oriented toward the vascular lumen.

### Claim 13 (depends on 12)

The method of claim 12, wherein the step of orienting the shaft of the orienting device includes expanding an orienting element on a distal region of the shaft within the vascular wall.

### Claim 14 (depends on 13)

The method of claim 13, wherein the orienting element includes at least one inflatable member.

### Claim 15 (depends on 13)

The method of claim 13, wherein the orienting element includes first and second inflatable members extending in opposite directions from the shaft.

### Claim 16 (depends on 15)

The method of claim 15, wherein the shaft defines first and second planetary lumens in fluid communication with the first and second inflatable members, respectively.

### Claim 17 (depends on 15)

The method of claim 15, wherein the first inflatable member has a first length and the second inflatable member has a second length different from the first length.

### Claim 18 (depends on 15)

The method of claim 15, wherein the first and second inflatable members each comprise an extruded portion of an outer wall of the shaft.

### Claim 19 (depends on 13)

The method of claim 13, wherein expanding the orienting element within the vascular wall causes the shaft to rotate about its central longitudinal axis.

### Claim 20 (depends on 13)

The method of claim 13, wherein the first aperture and the second aperture are located between proximal and distal ends of the orienting element.