# US 11,992,238 B2 · Endovascular device with a tissue piercing distal probe and associated methods

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- Number: US 11,992,238 B2
- Document ID: US11992238B2
- Status: Granted
- Kind: B2
- Application number: 18/075,110
- Filed: 2022-12-05
- Published: 2023-03-30
- Granted: 2024-05-28
- Earliest claimed: 2008-02-05
- Assignees: Boston Scientific Scimed, Inc.
- Applicants: Boston Scientific Scimed, Inc.
- Inventors: Matthew J. Olson; Chad J. Kugler; Ross A. Olson; David B. Robinson; Peter A. Jacobs
- Web page: https://patentgrep.com/patent/US11992238B2

## CPC

- 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 17/11: for performing anastomosis; Buttons for anastomosis
- A61B 17/3478: {Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067)}
- A61M 25/09: Guide wires
- 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 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 2017/00336: {with a protective sleeve, e.g. retractable or slidable}
- A61B 2017/00438: {connectable to a finger}
- A61B 2017/00778: {Operations on blood vessels (A61B2017/22097, A61B2017/320741 take precedence)}
- A61B 2017/1107: {for blood vessels}
- A61B 2017/22044: {with a pointed tip}
- A61B 2017/22048: {Balloons}
- A61B 2017/22054: {with two balloons}
- 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 2017/320044: {Blunt dissectors}
- A61B 2017/3488: {Fixation to inner organ or inner body tissue}
- A61B 2090/036: {abutting on tissue or skin}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61M 25/007: {Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked}
- A61M 25/1002: {characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence)}
- A61M 25/1011: {Multiple balloon catheters}
- A61M 2025/0096: {being laterally outward extensions or tools, e.g. hooks or fibres}
- A61M 2025/0197: {for creating an artificial passage within the body, e.g. in order to go around occlusions}
- A61M 2025/09083: {having a coil around a core}
- A61M 2025/09183: {having tools at the distal tip}
- 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

Devices, systems and methods for treating diseases and disorders effecting the cardiovascular system of the human body are disclosed. An exemplary device in accordance with this disclosure comprises a shaft, tip member fixed to the shaft, and a probe extending beyond a distal surface of the tip member. In some useful embodiments, the tip member is relatively atraumatic and the probe is shaped so as to be more likely to produce trauma than the tip member.

## Claims

### Claim 1

A re-entry device, comprising:
an elongate shaft;
a tip member attached to a distal segment of the elongate shaft;
a helical coil having a proximal end attached to the elongate shaft and a distal end attached to the tip member; and
a probe extending distally beyond a distal surface of the tip member;
wherein the re-entry device is biased to assume a bent shape including a bend disposed along the distal segment.

### Claim 2 (depends on 1)

The re-entry device of claim 1, wherein the helical coil includes a proximal leg and a distal leg, and the bend is disposed between the proximal leg and the distal leg.

### Claim 3 (depends on 1)

The re-entry device of claim 1, wherein the bend is formed at an obtuse angle.

### Claim 4 (depends on 1)

The re-entry device of claim 1, wherein the elongate shaft includes a proximal segment having an outer diameter greater than an outer diameter of the distal segment.

### Claim 5 (depends on 4)

The re-entry device of claim 4, wherein the elongate shaft further includes a tapered segment disposed between the proximal segment and the distal segment.

### Claim 6 (depends on 5)

The re-entry device of claim 5, wherein the proximal end of the helical coil is secured to the tapered segment.

### Claim 7 (depends on 1)

The re-entry device of claim 1, wherein the probe is monolithically formed with the tip member.

### Claim 8 (depends on 7)

The re-entry device of claim 7, wherein the distal segment extends into the tip member.

### Claim 9 (depends on 1)

The re-entry device of claim 1, wherein the distal segment of the elongate shaft extends through the tip member.

### Claim 10 (depends on 9)

The re-entry device of claim 9, wherein the distal segment of the elongate shaft forms the probe.

### Claim 11 (depends on 1)

The re-entry device of claim 1, wherein the distal surface has a generally hemispherical shape.

### Claim 12 (depends on 1)

The re-entry device of claim 1, wherein the probe has a generally cylindrical shape.

### Claim 13 (depends on 1)

The re-entry device of claim 1, wherein the probe is adapted and configured to pierce tissue.

### Claim 14 (depends on 1)

The re-entry device of claim 1, wherein the probe has an outer diameter less than an outer diameter of the tip member.

### Claim 15

A system for treating an occluded vessel, comprising:
an orienting device including an elongate tubular member having a side wall defining a central lumen and a first aperture extending through the side wall to communicate with the central lumen;
wherein the orienting device includes an orienting element coupled to the elongate tubular member and configured to orient the first aperture toward a true lumen of the occluded vessel; and
a re-entry device comprising an elongate shaft, a tip member attached to a distal segment of the elongate shaft, a helical coil having a proximal end attached to the elongate shaft and a distal end attached to the tip member, and a probe extending distally beyond a distal surface of the tip member;
wherein the re-entry device is biased to assume a bent shape including a bend disposed along the distal segment.

### Claim 16 (depends on 15)

The system of claim 15, wherein the orienting element includes a first portion extending in a first direction away from the elongate tubular member and a second portion extending in a second direction away from the elongate tubular member opposite the first direction.

### Claim 17 (depends on 16)

The system of claim 16, wherein the first aperture opens outwardly from the side wall in a third direction between the first direction and the second direction.

### Claim 18 (depends on 17)

The system of claim 17, wherein the side wall of the elongate tubular member further defines a second aperture extending through the side wall to communicate with the central lumen;
wherein the second aperture opens outwardly from the side wall in a fourth direction opposite the third direction.

### Claim 19 (depends on 18)

The system of claim 18, wherein the second aperture is longitudinally spaced apart from the first aperture.

### Claim 20 (depends on 15)

The system of claim 15, wherein the distal surface of the tip member has a convex shape, and the probe has a cylindrical shape extending distally beyond the distal surface to a distal face oriented perpendicular to a longitudinal axis of the probe.
