# US 12,213,676 B2 · Systems and methods for customizable flow diverter implants

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- Number: US 12,213,676 B2
- Document ID: US12213676B2
- Status: Granted
- Kind: B2
- Application number: 18/776,051
- Filed: 2024-07-17
- Published: 2024-12-05
- Granted: 2025-02-04
- Earliest claimed: 2023-02-22
- Assignees: eLum Technologies, Inc.
- Applicants: eLum Technologies, Inc.
- Inventors: Quang Tran; Yen Tu; Noelle Bagnall; Victor Barajas; David Li
- Web page: https://patentgrep.com/patent/US12213676B2

## CPC

- A61B 17/12109: {in a blood vessel}
- A61F 2/966: with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
- A61B 17/12031: {complete occlusion}
- A61B 17/12172: {having a pre-set deployed three-dimensional shape (methods of manufacturing A61B2017/00526)}
- A61B 2017/00477: {Coupling (A61B2017/0046 takes precedence)}
- A61B 2017/1205: {Introduction devices}
- A61F 2/0095: {Packages or dispensers for prostheses or other implants (for intraocular lenses A61F2/1691; for dental surgery A61C19/02)}
- A61F 2002/823: {Stents, different from stent-grafts, adapted to cover an aneurysm}
- A61F 2002/9665: {with additional retaining means}
- 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)

## Abstract

Neurovascular flow diverter and delivery systems, and methods of using the same are described herein. The systems can include a customizing member including an introducer sheath, a catheter, a deployable flow diverter that can be contained in the introducer sheath or in the catheter, a core wire, and one or several deployment features coupled to the core wire and engaging the flow diverter. The customizing member includes a tubing extending along and around a distal portion of the introducer sheath. This tubing is cuttable and contains a distal end of the flow diverter. The length of the flow diverter can be customized by cutting through the tubing and the therein contained flow diverter.

## Claims

### Claim 1

A system for customizing a flow diverter for delivery into a neurovascular blood vessel to treat an aneurysm, the system comprising:
an elongate tubular member having a proximal end and a distal end, the elongate tubular member comprising an interior wall defining a lumen;
a flow diverter comprising a proximal end and a distal end, wherein the flow diverter is partially contained within the lumen of the elongate tubular member in a constrained configuration, wherein the flow diverter extends a first length beyond the distal end of the elongate tubular member;
a deployment wire extending within the lumen of the elongate tubular member, the deployment wire having a proximal end, a distal end, and a distal portion having a taper, the deployment wire comprising at least one deployment feature coupled to the flow diverter such that movement of the deployment wire relative to the elongate tubular member moves the flow diverter relative to the elongate tubular member; and
a housing coupled to the elongate tubular member and defining a template for customizing the flow diverter.

### Claim 2 (depends on 1)

The system of claim 1, wherein the elongate tubular member comprises an introducer sheath having a proximal end and a distal end, wherein the introducer sheath is cuttable.

### Claim 3 (depends on 1)

The system of claim 1, further comprising a tubing extending along and around a distal portion of the elongate tubular member, wherein the tubing extends a second length beyond the distal end of the elongate tubular member, wherein the distal end of the flow diverter is within the tubing, and wherein the tubing is cuttable.

### Claim 4 (depends on 3)

The system of claim 3, wherein the tubing is peelably removable from the distal portion of the elongate tubular member.

### Claim 5 (depends on 4)

The system of claim 4, wherein the deployment wire terminates in a proximal portion of the peelable tubing.

### Claim 6 (depends on 3)

The system of claim 3, wherein the tubing comprises a proximal end, a distal end, a first longitudinal portion having a first proximal pull tab, and a second longitudinal portion having a second proximal pull tab, each of the first longitudinal portion and the second longitudinal portion extending from the proximal end of the tubing to the distal end of the tubing, wherein the tubing is peelably removable from the distal portion of the elongate tubular member by separating the first longitudinal portion from the second longitudinal portion.

### Claim 7 (depends on 3)

The system of claim 3, wherein the flow diverter is cuttable within the tubing to a variable length.

### Claim 8 (depends on 1)

The system of claim 1, wherein the template comprises equally spaced graduation markings, wherein the graduation markings are configured to aid in cutting the flow diverter to a variable length.

### Claim 9 (depends on 8)

The system of claim 8, wherein the template further comprises a cutting aperture, slit, or notch extending through the housing, wherein the cutting aperture, slit, or notch is disposed proximally of the graduation markings.

### Claim 10 (depends on 8)

The system of claim 8, wherein the template further comprises an alignment member disposed below the graduation markings for guiding the flow diverter relative to the graduation markings and holding the flow diverter stationary during cutting.

### Claim 11 (depends on 8)

The system of claim 8, wherein the template correlates the graduation markings to a deployed length of the flow diverter.

### Claim 12 (depends on 1)

The system of claim 1, wherein the template further comprises a cutting aperture extending through the housing, wherein a width of the cutting aperture constrains a cutting tool to aid in cutting the flow diverter at a desired location or desired angle.

### Claim 13 (depends on 12)

The system of claim 12, wherein the template further comprises an opening extending through the housing for retraction and advancement of the tubing relative to the graduation markings, wherein the opening is disposed proximally of the cutting aperture.

### Claim 14 (depends on 1)

The system of claim 1, wherein the at least one deployment feature comprises:
a pusher extending along and around the distal portion of the deployment wire, the pusher having a distal end configured to engage with the proximal end of the flow diverter;
at least one friction bump positioned along the distal portion of the deployment wire extending distally beyond the pusher, wherein the at least one friction bump is inside of the flow diverter and engaged with a portion of the flow diverter; and
a tip coil extending distally from the at least one friction bump.

### Claim 15 (depends on 1)

The system of claim 1, wherein the flow diverter comprises a self-expanding member having a proximal end and a distal end.

### Claim 16 (depends on 1)

The system of claim 1, wherein the housing comprises a packaging tray.

### Claim 17

A method for customizing a flow diverter for delivery into a neurovascular blood vessel to treat an aneurysm, the method comprising:
providing a flow diverter delivery system comprising:
an elongate tubular member having a proximal end and a distal end, the elongate tubular member comprising an interior wall defining a lumen;
a flow diverter comprising a proximal end and a distal end, wherein the flow diverter is partially contained within the lumen of the elongate tubular member in a constrained configuration, wherein the flow diverter extends a first length beyond the distal end of the elongate tubular member;
a deployment wire extending within the lumen of the elongate tubular member, the deployment wire having a proximal end, a distal end, and a distal portion having a taper, the deployment wire comprising at least one deployment feature coupled to the flow diverter;
a housing coupled to the elongate tubular member and defining a template; and
a tubing extending along and around a distal portion of the elongate tubular member, wherein the tubing extends a second length beyond the distal end of the elongate tubular member, wherein the distal end of the flow diverter is within the tubing;
determining a desired length of the flow diverter using the template;
advancing or retracting the tubing relative to the housing to align the flow diverter to the template;
cutting the tubing and the flow diverter such that the flow diverter is cut to the desired length; and
retracting the flow diverter into the elongate tubular member or advancing the elongate tubular member over the flow diverter.

### Claim 18 (depends on 17)

The method of claim 17, further comprising separating the tubing from the distal portion of the elongate tubular member after retracting the flow diverter into the elongate tubular member or advancing the elongate tubular member over the flow diverter.

### Claim 19 (depends on 18)

The method of claim 18, wherein separating the tubing from the distal portion of the elongate tubular member comprises peeling the tubing away from the distal portion of the elongate tubular member.

### Claim 20 (depends on 19)

The method of claim 19, wherein the deployment wire terminates in a proximal portion of the tubing and within the constrained flow diverter.

### Claim 21 (depends on 17)

The method of claim 17, further comprising moving the deployment wire relative to the elongate tubular member such that the flow diverter moves relative to the elongate tubular member.

### Claim 22 (depends on 17)

The method of claim 17, wherein advancing or retracting the tubing relative to the template includes positioning the flow diverter relative to graduation markings equally spaced along the template, wherein the graduation markings are configured to aid in cutting the flow diverter to the desired length.

### Claim 23 (depends on 22)

The method of claim 22, wherein advancing or retracting the tubing relative to the template includes positioning the tubing within an alignment member disposed below the graduation markings for guiding the flow diverter relative to the graduation markings and holding the flow diverter stationary during cutting.

### Claim 24 (depends on 22)

The method of claim 22, wherein advancing or retracting the tubing includes adjusting the tubing relative to the graduation markings via an opening extending through the housing and disposed proximally of the graduation markings.

### Claim 25 (depends on 22)

The method of claim 22, wherein cutting the tubing and flow diverter comprises using a cutting tool to cut the flow diverter at a desired location or a desired angle via a cutting aperture, slit, or notch extending through the housing.

### Claim 26 (depends on 25)

The method of claim 25, wherein the cutting aperture, slit, or notch is positioned between the opening and the graduation markings and constrains the cutting tool during the cutting.

### Claim 27 (depends on 22)

The method of claim 22, wherein the template correlates the graduation markings to a deployed length of the flow diverter.

### Claim 28 (depends on 22)

The method of claim 22, wherein retracting the flow diverter into the elongate tubular member comprises distally retracting the deployment wire.

### Claim 29 (depends on 22)

The method of claim 22, wherein advancing the elongate tubular member over the flow diverter comprises holding the deployment wire stationary while advancing the elongate tubular member.

### Claim 30 (depends on 17)

The method of claim 17, wherein the housing comprises a packaging tray.
