# US 2021/0330332 A1 · Endovascular interventions in neurovascular anatomy

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 2021/0330332 A1
- Document ID: US20210330332A1
- Status: Published application
- Kind: A1
- Application number: 16/319,038
- Filed: 2017-07-21
- Published: 2021-10-28
- Earliest claimed: 2016-07-22
- Assignees: Route 92 Medical, Inc.
- Applicants: Route 92 Medical, Inc.
- Inventors: Tony M. Chou; Joey English
- Web page: https://patentgrep.com/patent/US20210330332A1

## CPC

- A61B 17/12118: {for positioning in conjunction with a stent}
- A61B 17/1214: {Coils or wires}
- A61F 2/958: Inflatable balloons for placing stents or stent-grafts
- A61F 2/966: with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
- A61K 31/616: by carboxylic acids, e.g. acetylsalicylic acid
- 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 2017/00893: {pharmaceutically effective}
- A61B 2017/1205: {Introduction devices}
- A61B 2017/22051: {with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation (A61B2017/22048, A61B2017/3486 take precedence)}
- A61B 2017/22069: {Immobilising; Stabilising}
- A61B 2017/2217: {single wire changing shape to a gripping configuration}
- A61F 2002/016: {made from wire-like elements}
- A61F 2002/9528: {for retrieval of stents}
- A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol
- 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)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

Method of endovascular intervention in neurovascular anatomy of a patient including deploying an anchor of a tethering device in an anchoring vessel of a neurovascular anatomy, the anchor coupled to a tether extending proximally from the anchor. Method includes advancing a guide-sheath over the tether of the tethering device anchored in the anchoring vessel and attached to the tether, the guide-sheath includes at least one lumen and a distal opening from the lumen. Method includes advancing a treatment device through the lumen of the guide-sheath and out the distal opening from the at least one lumen and through an entrance of a target intracranial vessel, and deploying the treatment device at a treatment site within the target intracranial vessel without a combined therapy of two or more anti-platelet therapeutic agents during a peri-procedural period. Related systems, devices, and methods are disclosed.

## Claims

### Claim 1

A method of endovascular intervention in neurovascular anatomy of a patient, the method comprising:
deploying an anchor of a tethering device in an anchoring vessel of a neurovascular anatomy, wherein the anchor is coupled to a tether extending proximally from the anchor;
advancing a guide-sheath over the tether of the tethering device anchored in the anchoring vessel and attached to the tether, the guide-sheath comprising at least one lumen and a distal opening from the lumen;
advancing a treatment device through the lumen of the guide-sheath and out the distal opening from the at least one lumen and through an entrance of a target intracranial vessel; and
deploying the treatment device at a treatment site within the target intracranial vessel without a combined therapy of two or more anti-platelet therapeutic agents during a peri-procedural period.

### Claim 2 (depends on 1)

The method of claim 1, wherein the target intracranial vessel defines a lumen and has a lumen wall with an aneurysm.

### Claim 3 (depends on 2)

The method of claim 2, wherein the aneurysm has a neck communicating with the lumen of the target intracranial vessel.

### Claim 4 (depends on 3)

The method of claim 3, wherein deploying the treatment device comprises deploying the treatment device at the neck of the aneurysm

### Claim 5 (depends on 4)

The method of claim 4, wherein deploying the treatment device comprises expanding the treatment device from a low-profile configuration to a high-profile configuration.

### Claim 6 (depends on 5)

The method of claim 5, wherein when in the high-profile configuration the treatment device has a longitudinal length that substantially matches a longitudinal length of the neck.

### Claim 7 (depends on 5)

The method of claim 5, wherein the treatment device is a self-expanding stent advanced by a self-expanding delivery system or a balloon-expandable stent advanced by a balloon-expanding delivery system.

### Claim 8 (depends on 5)

The method of claim 5, wherein the treatment device is a flow diverter or a stent configured to assist in the deployment of a coil in the aneurysm.

### Claim 9 (depends on 8)

The method of claim 8, wherein the flow diverter has vessel coverage of between 30%-35% and a braid count of at least 48.

### Claim 10 (depends on 9)

The method of claim 9, further comprising preventing blood flow through the neck of the aneurysm with the treatment device.

### Claim 11 (depends on 6)

The method of claim 6, wherein the longitudinal length of the treatment device when in the high-profile configuration is between about 1 cm and about 4 cm, or between 4 cm and about 6 cm, or between about 4 cm and about 10 cm, or between about 4 cm and about 20 cm.

### Claim 12 (depends on 11)

The method of claim 11, wherein a collective length the treatment device extends beyond the neck of the aneurysm being treated is no more than about 1-2 mm.

### Claim 13 (depends on 4)

The method of claim 4, wherein the treatment device is limited to a length sufficient to bridge the neck of the aneurysm without extending substantially beyond on either side of the neck.

### Claim 14 (depends on 13)

The method of claim 13, wherein the aneurysm is located near a perforating vessel.

### Claim 15 (depends on 14)

The method of claim 14, wherein the treatment device avoids extending to the perforating vessel when bridging the neck of the aneurysm.

### Claim 16 (depends on 4)

The method of claim 4, wherein the aneurysm is a ruptured aneurism associated with subarachnoid hemorrhage (SAH) having a contraindication for dual anti-platelet therapy (DAPT).

### Claim 17 (depends on 16)

The method of claim 16, further comprising treating the patient with a single-anti-platelet therapeutic agent during the peri-procedural period.

### Claim 18 (depends on 17)

The method of claim 17, wherein treating the patient comprises treating the patient with aspirin-only in the peri-procedural period.

### Claim 19 (depends on 4)

The method of claim 4, wherein deploying the treatment device comprises deploying a first stent device having a first amount of vessel coverage and a first biased pattern such that at least a portion of the first stent device bridges the neck of the aneurysm upon expanding the device from a low-profile configuration to a high-profile configuration.

### Claim 20 (depends on 19)

The method of claim 19, further comprising deploying a second stent device having a second amount of vessel coverage and a second biased pattern, wherein the second amount of vessel coverage is substantially the same as the first amount of vessel coverage.

### Claim 21 (depends on 20)

The method of claim 20, wherein the second stent device is deployed inside the expanded first stent device relative to the first stent device such that the second biased pattern runs counter to the first biased pattern creating a third amount of vessel coverage at an overlap region between the first and second stent devices that is greater than either the first or the second vessel coverage.

### Claim 22 (depends on 21)

The method of claim 21, wherein the overlap region has a length that is substantially the same as a length of the neck of the aneurysm.

### Claim 23 (depends on 22)

The method of claim 22, wherein the first and the second amount of vessel coverage is between about 10%-15%.

### Claim 24 (depends on 23)

The method of claim 23, wherein the third amount of vessel coverage at the overlap region is between about 20%-30%.

### Claim 25 (depends on 22)

The method of claim 22, wherein the length of the overlap region is between about 2 mm and about 4 mm, or between 4 mm and about 6 mm, or between about 4 mm and about 10 mm, or between about 4 mm and about 20 mm.

### Claim 26 (depends on 25)

The method of claim 25, wherein the length the overlap region extends beyond the neck of the aneurysm being treated no more than about 2 mm, no more than about 4 mm, no more than about 6 mm, no more than about 8 mm, or no more than about 10 mm.

### Claim 27 (depends on 25)

The method of claim 25, the length of the overlap region is limited to a length sufficient to bridge the neck of the aneurysm without extending substantially beyond on either side of the neck.

### Claim 28 (depends on 21)

The method of claim 21, further comprising treating the patient with a single anti-platelet therapeutic agent during the peri-procedural period.

### Claim 29 (depends on 28)

The method of claim 28, further comprising treating the patient with aspirin-only in the peri-procedural period.

### Claim 30 (depends on 1)

The method of claim 1, wherein deploying the treatment device comprises deploying the treatment device to treat a narrowing within the target intracranial vessel.

### Claim 31 (depends on 30)

The method of claim 30, wherein deploying the treatment device comprises expanding the treatment device from a low-profile configuration to a high-profile configuration.

### Claim 32 (depends on 31)

The method of claim 31, wherein when in the high-profile configuration the treatment device has a longitudinal length that substantially matches a longitudinal length of the narrowing.

### Claim 33 (depends on 32)

The method of claim 32, wherein the treatment device is a self-expanding stent advanced by a self-expanding delivery system or a balloon-expandable stent advanced by a balloon-expanding delivery system.

### Claim 34 (depends on 32)

The method of claim 32, wherein the longitudinal length of the treatment device when in the high-profile configuration is between about 2 mm and about 4 mm, or between 4 mm and about 6 mm, or between about 4 mm and about 10 mm, or between about 4 mm and about 20 mm.

### Claim 35 (depends on 34)

The method of claim 34, wherein a collective length the treatment device extends beyond the narrowing being treated is no more than about 2 mm, no more than about 4 mm, no more than about 6 mm, no more than about 8 mm, or no more than about 10 mm.

### Claim 36 (depends on 30)

The method of claim 30, wherein the treatment device is limited to a length sufficient to bridge the narrowing without extending substantially beyond on either side of the narrowing.

### Claim 37 (depends on 30)

The method of claim 30, further comprising treating the patient with a single anti-platelet therapeutic during the peri-procedural period.

### Claim 38 (depends on 37)

The method of claim 37, wherein treating the patient comprises treating the patient with aspirin-only in the peri-procedural period.

### Claim 39 (depends on 1)

The method of claim 1, wherein the treatment device is a stent and the guide-sheath anchor allows for precise placement of the stent to minimize stent length.

### Claim 40 (depends on 1)

The method of claim 1, wherein the treatment device is a balloon expandable stent and the guide-sheath anchor allows for precise placement of the stent to minimize stent length.

### Claim 41 (depends on 1)

The method of claim 1, wherein the treatment device is a covered or coated stent.

### Claim 42 (depends on 1)

The method of claim 1, wherein the treatment device is a pair of overlapping stents configured to facilitate stent-assisted coiling and flow diversion through the target intracranial vessel.

### Claim 43 (depends on 1)

The method of claim 1, wherein the step of deploying the anchor comprises forming a first fixation point.

### Claim 44 (depends on 43)

The method of claim 43, further comprising attaching the guide-sheath to the tether of the tethering device forming a second fixation point proximal to the first fixation point.

### Claim 45 (depends on 44)

The method of claim 44, wherein the treatment site is distal to the first fixation point.

### Claim 46 (depends on 45)

The method of claim 45, wherein the treatment device is a balloon-expandable stent, a self-expanding stent, or a flow diverter.

### Claim 47 (depends on 45)

The method of claim 45, wherein the treatment site is an aneurysm.

### Claim 48 (depends on 47)

The method of claim 47, wherein the first fixation point is formed in the anchoring vessel near a bifurcation between the anchoring vessel and a vessel leading to the treatment site.

### Claim 49 (depends on 48)

The method of claim 48, wherein advancing the treatment device through the at least one lumen of the guide-sheath tensions the tether between the first fixation point and the second fixation point.

### Claim 50 (depends on 1)

The method of claim 1, wherein deploying the anchor comprises deploying the anchor from a low profile configuration to a higher profile configuration.

### Claim 51 (depends on 1)

The method of claim 1, wherein advancing the guide-sheath over the tether comprises advancing the guide-sheath over the tether such that the tether extends at least in part through the at least one lumen of the guide-sheath, wherein the lumen through which the tether extends is the same or different as the lumen through which the treatment device is advanced.

### Claim 52 (depends on 51)

The method of claim 51, wherein the guide-sheath comprises at least a second lumen, and the tether extends through at least a portion of the second lumen.

### Claim 53 (depends on 44)

The method of claim 44, wherein attaching the guide-sheath to the tether comprises using a tether gripper at the second point of fixation to attach the guide-sheath to the tether of the tethering device.

### Claim 54 (depends on 53)

The method of claim 53, wherein the tether gripper is on one or both of the tethering device and the guide-sheath.

### Claim 55 (depends on 1)

The method of claim 1, further comprising preventing prolapse of the guide-sheath during deployment of the treatment device.

### Claim 56 (depends on 1)

The method of claim 1, further comprising resisting tension stored in the guide-sheath during deployment of the treatment device.

### Claim 57 (depends on 1)

The method of claim 1, wherein the treatment device is a self-expanding stent and deploying the treatment device at the treatment site comprises unsheathing the self-expanding stent by withdrawing proximally a constraint.

### Claim 58 (depends on 57)

The method of claim 57, further comprising preventing the self-expanding stent from missing the treatment site during unsheathing.

### Claim 59 (depends on 58)

The method of claim 58, further comprising removing the anchor from the anchoring vessel; and removing the guide-sheath.

### Claim 60 (depends on 1)

The method of claim 1, further comprises:
advancing a guidewire near the anchoring vessel; and
exchanging the guidewire for a tethering device.

### Claim 61 (depends on 1)

The method of claim 1, wherein the treatment device is a self-expanding stent and deploying the treatment device at the treatment site comprises unsheathing the self-expanding stent by withdrawing proximally a constraint.

### Claim 62 (depends on 61)

The method of claim 61, further comprising preventing the self-expanding stent from missing the treatment site during unsheathing.

### Claim 63

An aneurysm treatment system comprising:
a first stent having a first biased pattern and a first vessel coverage; and
a second stent having the second biased pattern and a second vessel coverage,
wherein the second stent is configured to be positioned in a counter-current manner within a lumen of the first stent forming an overlap having a third vessel coverage.

### Claim 64 (depends on 63)

The treatment system of claim 63, wherein the first and second stent are configured to be implanted in combination with a coil positioned within an aneurysm.

### Claim 65 (depends on 63)

The treatment system of claim 63, wherein the first biased pattern is a first helical pattern and the second biased pattern is a second helical pattern.

### Claim 66 (depends on 65)

The treatment system of claim 65, wherein the first helical pattern is configured to be oriented along a first current.

### Claim 67 (depends on 66)

The treatment system of claim 66, wherein the second stent is configured to be positioned within the lumen of the first stent upon expansion of the first stent.

### Claim 68 (depends on 67)

The treatment system of claim 67, wherein the second helical pattern runs counter to the bias of the first helical pattern.

### Claim 69 (depends on 63)

The treatment system of claim 63, wherein the overlap between the first stent and the second stent provides the third vessel coverage, the third vessel coverage being greater than the first vessel coverage or the second vessel coverage.

### Claim 70 (depends on 63)

The treatment system of claim 63, wherein a length of the overlap is adjustable.

### Claim 71 (depends on 70)

The treatment system of claim 70, wherein the adjustable length of the overlap allows for tailoring density of the third vessel coverage and a location of the third vessel coverage relative to anatomy within which the first and second stents are implanted.
