# US 11,076,882 B2 · Endovascular devices and methods

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- Number: US 11,076,882 B2
- Document ID: US11076882B2
- Status: Granted
- Kind: B2
- Application number: 16/174,518
- Filed: 2018-10-30
- Published: 2019-02-28
- Granted: 2021-08-03
- Earliest claimed: 2005-09-12
- Assignees: BridgePoint Medical, Inc.
- Applicants: Bridgepoint Medical, Inc.
- Inventors: Chad J. Kugler; Robert E. Atkinson
- Web page: https://patentgrep.com/patent/US11076882B2

## CPC

- A61B 17/32037: {for removing obstructions from inner organs or blood vessels, e.g. for atherectomy}
- 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 17/22031: {Gripping instruments, e.g. forceps, for removing or smashing calculi (A61B17/221 takes precedence)}
- 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)}
- A61F 2/88: the wire-like elements formed as helical or spiral coils
- A61M 25/0194: {Tunnelling catheters}
- A61M 25/104: {used for angioplasty}
- A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)}
- A61B 17/00008: {Vein tendon strippers (tube strippers A61M1/83)}
- A61B 2017/00252: {for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel}
- A61B 2017/22034: {for gripping the obstruction or the tissue part from inside}
- A61B 2017/22077: {with a part piercing the tissue (A61B2017/22044 takes precedence)}
- 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 2017/320056: {Tunnelers}
- A61B 2017/320064: {with tissue or sample retaining means}
- A61B 2017/320733: {with a flexible cutting or scraping element, e.g. with a whip-like distal filament member}
- A61B 2017/320741: {for stripping the intima or the internal plaque from a blood vessel, e.g. for endarterectomy}
- A61M 25/0026: {Multi-lumen catheters with stationary elements (catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175)}
- A61M 2025/006: {having a special surface topography or special surface properties, e.g. roughened or knurled surface}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- 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

Devices and methods for the treatment of chronic total occlusions are provided. One disclosed embodiment comprises a method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein. The method includes providing an intravascular device having a distal portion, inserting the device into the vascular lumen, positioning the distal portion in the vascular wall to at least partially surround the occlusion, and removing at least a portion of the surrounded occlusion from the lumen.

## Claims

### Claim 1

A method of treating an occlusion in a vascular lumen defined by a vessel wall, the occlusion separating a portion of the vascular lumen proximal of the occlusion from a portion of the vascular lumen distal of the occlusion, comprising:
inserting a guidewire into the vascular lumen and advancing a distal end of the guidewire to a position adjacent the occlusion;
advancing a catheter over the guidewire into the vascular lumen to the position adjacent the occlusion, the catheter including a balloon proximate a distal end of the catheter, a guidewire lumen having the guidewire slidably disposed therein, and a device lumen extending to a distal opening;
inflating the balloon to an inflated configuration against an intima of the vessel wall at the position adjacent the occlusion;
advancing a distal portion of a subintimal device disposed within the device lumen out of the distal opening and through the intima into a subintimal space within the vessel wall such that a distal end of the subintimal device remains within the subintimal space upon concluding the advancement of the subintimal device; and
withdrawing the subintimal device from the subintimal space such that the subintimal space is only in fluid communication with the portion of the vascular lumen disposed proximal of the occlusion.

### Claim 2 (depends on 1)

The method of claim 1, further comprising:
delaminating tissue layers of the vessel wall adjacent the occlusion.

### Claim 3 (depends on 2)

The method of claim 2, wherein delaminating tissue layers of the vessel wall includes infusing a fluid into the subintimal space.

### Claim 4 (depends on 3)

The method of claim 3, wherein the fluid is infused directly into the subintimal space from the device lumen.

### Claim 5 (depends on 3)

The method of claim 3, wherein the fluid is infused into the subintimal space through the subintimal device.

### Claim 6 (depends on 2)

The method of claim 2, wherein delaminating tissue layers of the vessel wall includes expanding the distal portion of the subintimal device from a collapsed configuration to an expanded configuration within the subintimal space.

### Claim 7 (depends on 2)

The method of claim 2, wherein delaminating tissue layers of the vessel wall includes manipulating the distal portion of the subintimal device within the subintimal space to delaminate tissue layers in the vessel wall.

### Claim 8 (depends on 1)

The method of claim 1, wherein the distal portion of the subintimal device is advanced along an exterior of the balloon.

### Claim 9 (depends on 1)

The method of claim 1, wherein the distal opening is positioned on an exterior of the balloon.

### Claim 10 (depends on 9)

The method of claim 9, wherein inflating the balloon positions the distal opening of the device lumen against the intima of the vessel wall.

### Claim 11 (depends on 1)

The method of claim 1, wherein the distal opening is located distal of a proximal end of the balloon.

### Claim 12

A method of treating an occlusion in a vascular lumen defined by a vessel wall, the occlusion separating a portion of the vascular lumen proximal of the occlusion from a portion of the vascular lumen distal of the occlusion, comprising:
advancing a catheter into the vascular lumen to a position proximal of the occlusion, the catheter including a balloon proximate a distal end of the catheter and a device lumen extending to a distal opening located proximal of a distal end of the balloon;
inflating the balloon to an inflated configuration against an intima of the vessel wall at the position adjacent the occlusion;
advancing a distal portion of a subintimal device disposed within the device lumen out of the distal opening and through the intima into a subintimal space within the vessel wall while the balloon is inflated such that a distal end of the subintimal device remains in the subintimal space upon concluding the advancement of the subintimal device; and
withdrawing the subintimal device from the subintimal space such that the subintimal space is only in fluid communication with the portion of the vascular lumen disposed proximal of the occlusion.

### Claim 13 (depends on 12)

The method of claim 12, wherein the distal portion of the subintimal device is advanced along an exterior of the balloon.

### Claim 14 (depends on 12)

The method of claim 12, wherein the distal opening is positioned on an exterior of the balloon.

### Claim 15 (depends on 14)

The method of claim 14, wherein inflating the balloon positions the distal opening of the device lumen against the intima of the vessel wall.

### Claim 16 (depends on 12)

The method of claim 12, wherein the catheter is advanced into the vascular lumen along a guidewire slidably positioned in a guidewire lumen extending through the balloon.

### Claim 17 (depends on 12)

The method of claim 12, wherein the distal opening is located distal of a proximal end of the balloon.

### Claim 18

A method of treating an occlusion in a vascular lumen defined by a vessel wall, the occlusion separating a portion of the vascular lumen proximal of the occlusion from a portion of the vascular lumen distal of the occlusion, comprising:
inserting a guidewire into the vascular lumen and advancing a distal end of the guidewire to a position adjacent the occlusion;
advancing a catheter over the guidewire into the vascular lumen to the position adjacent the occlusion, the catheter including a balloon proximate a distal end of the catheter, a guidewire lumen extending through the balloon and having the guidewire slidably disposed therein, and a device lumen extending along an exterior of the balloon;
inflating the balloon to an inflated configuration at the position adjacent the occlusion to position a distal portion of the device lumen against an intima of the vessel wall;
advancing a distal portion of a subintimal device disposed within the device lumen through the intima into a subintimal space within the vessel wall such that a distal end of the subintimal device remains within the subintimal space upon concluding the advancement of the subintimal device;
delaminating tissue layers of the vessel wall adjacent the occlusion; and
withdrawing the subintimal device from the subintimal space such that the subintimal space is only in fluid communication with the portion of the vascular lumen disposed proximal of the occlusion.

### Claim 19 (depends on 18)

The method of claim 18, wherein delaminating tissue layers of the vessel wall includes expanding the distal portion of the subintimal device from a collapsed configuration to an expanded configuration within the subintimal space.

### Claim 20 (depends on 18)

The method of claim 18, wherein delaminating tissue layers of the vessel wall includes manipulating the distal portion of the subintimal device within the subintimal space to delaminate tissue layers in the vessel wall.
