# US 12,213,688 B2 · Anchoring delivery system and methods

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- Number: US 12,213,688 B2
- Document ID: US12213688B2
- Status: Granted
- Kind: B2
- Application number: 17/545,885
- Filed: 2021-12-08
- Published: 2022-03-31
- Granted: 2025-02-04
- Earliest claimed: 2015-07-24
- Assignees: Route 92 Medical, Inc.
- Applicants: Route 92 Medical, Inc.
- Inventors: Tony M. Chou; Joey English; Randolf Von Oepen; Scott D. Wilson; Kirsten Valley; Philip Evard
- Web page: https://patentgrep.com/patent/US12213688B2

## CPC

- 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)}
- A61M 25/01: Introducing, guiding, advancing, emplacing or holding catheters (A61M25/10 takes precedence)
- A61M 25/04: in the body, e.g. expansible {(A61M25/10, A61M16/0488 take precedence)}
- A61M 25/0662: {Guide tubes}
- A61B 2017/00986: {Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts}
- A61B 2017/00991: {Telescopic means}
- A61B 2017/22047: {Means for immobilising the guide wire in the patient}
- A61B 2017/22049: {Means for locking the guide wire in the catheter}
- A61B 2017/22069: {Immobilising; Stabilising}
- A61M 2025/0681: {Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube}
- A61M 2025/09125: {Device for locking a guide wire in a fixed position with respect to the catheter or the human body}
- 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

An anchoring delivery system for use in an intracranial artery is provided including a tethering device having an elongated tether and an anchor coupled to a distal end of the tether. The anchor is deployable from a low profile configuration to a higher profile configuration to fix the distal end of the tether at an anchoring site in an anchoring vessel. The tethering device is configured to be used with a guide-sheath having a lumen configured to receive the tether. Related devices, systems, and methods are also described.

## Claims

### Claim 1

A method of performing a medical procedure at a treatment site in a cerebral vessel of a patient, the method comprising:
delivering a neurovascular catheter through a working lumen of a sheath to a treatment location distal to a petrous portion of an internal carotid artery, the neurovascular catheter comprising:
an elongate control element configured to advance the neurovascular catheter comprising a flat ribbon; and
a distal luminal portion extending along a longitudinal axis having a proximal end region coupled to the control element, wherein the distal luminal portion has a side wall defining a single, inner lumen, the side wall comprising:
a tubular inner liner;
a reinforcement structure wound around and bonded to the tubular inner liner; and
an outer jacket surrounding the reinforcement structure,
wherein a distal end of the elongate control element is coupled to the proximal end region of the distal luminal portion sandwiched between layers of the side wall, and
wherein the proximal end region of the distal luminal portion includes a step-up in outer diameter to form a seal with the working lumen of the sheath; and
applying suction through the working lumen of the sheath and the single, inner lumen of the neurovascular catheter to the treatment location from a single source of suction.

### Claim 2 (depends on 1)

The method of claim 1, wherein the distal luminal portion has a transition section near where the distal luminal portion couples to the elongate control element.

### Claim 3 (depends on 2)

The method of claim 2, wherein the transition section has an angled cut.

### Claim 4 (depends on 3)

The method of claim 3, wherein the proximal opening is formed within the transition section and the proximal end region of the distal luminal portion is coupled to the distal end region of the control element adjacent the transition section.

### Claim 5 (depends on 1)

The method of claim 1, wherein a proximal end of the elongate flexible control element is coupled to a tab.

### Claim 6 (depends on 1)

The method of claim 1, further comprising organizing the control element of the neurovascular catheter and a component used with the catheter by engaging a reversible coupling feature on the control element to the component.

### Claim 7 (depends on 1)

The method of claim 1, wherein the flat ribbon has a rectangular cross-sectional dimension that is wider than it is thick.

### Claim 8 (depends on 1)

The method of claim 1, wherein a maximum cross-sectional dimension of the flat ribbon is 0.025″.

### Claim 9 (depends on 1)

The method of claim 1, advancing the neurovascular catheter through the sheath from a transfemoral access site to a middle cerebral artery so that the proximal end region of the distal luminal portion remains outside the aortic arch.

### Claim 10 (depends on 9)

The method of claim 9, further comprising the steps of:
inserting the sheath into a blood vessel from the transfemoral access site, wherein the working lumen of the sheath extends between a proximal end region and a distal end region of the sheath, the distal end region having at least one opening in communication with the working lumen; and
advancing the sheath toward a treatment location.

### Claim 11 (depends on 10)

The method of claim 10, further comprising advancing the sheath over a tethering device anchored at an anchoring site proximal of the treatment site.

### Claim 12 (depends on 10)

The method of claim 10, wherein the sheath is advanced to a location within the petrous segment of the internal carotid artery.

### Claim 13 (depends on 1)

The method of claim 1, wherein delivering the neurovascular catheter to a treatment location distal to the petrous portion comprises advancing a catheter system comprising the neurovascular catheter and a catheter advancement element positioned within the inner lumen of the catheter, wherein a tapered distal tip of the catheter advancement element extends distal to a distal end of the neurovascular catheter during the delivering.

### Claim 14 (depends on 13)

The method of claim 13, further comprising withdrawing the catheter advancement element from the single, inner lumen.

### Claim 15 (depends on 14)

The method of claim 14, further comprising placing the distal end of the neurovascular catheter on or near a proximal face of an occlusion at the treatment location.

### Claim 16 (depends on 15)

The method of claim 15, further comprising removing occlusive material while applying suction capturing the occlusive material at, within, or through the distal end of the neurovascular catheter.

### Claim 17 (depends on 16)

The method of claim 16, wherein applying suction through the sheath and the inner lumen of the neurovascular catheter comprises initiating aspiration from the single source of suction at a level suitable for distal embolic protection.

### Claim 18 (depends on 16)

The method of claim 16, wherein applying suction through the sheath and the inner lumen of the neurovascular catheter comprises initiating aspiration from the single source of suction at a level suitable for aspiration thrombectomy.

### Claim 19 (depends on 1)

The method of claim 1, wherein applying suction through the sheath and the inner lumen of the neurovascular catheter comprises applying suction through a contiguous lumen formed by the single, inner lumen of the distal luminal portion and the working lumen of the sheath to remove occlusive material through the contiguous lumen.

### Claim 20 (depends on 19)

The method of claim 19, further comprising delivering a fluid through the working lumen of the sheath.

### Claim 21 (depends on 20)

The method of claim 20, wherein the fluid comprises angiographic contrast, saline, or at least one drug.

### Claim 22 (depends on 19)

The method of claim 19, wherein applying suction through the contiguous lumen comprises applying suction to a distal end of the neurovascular catheter as the neurovascular catheter is retracted inside of the sheath.

### Claim 23 (depends on 19)

The method of claim 19, further comprising advancing a second catheter through the neurovascular catheter to a second treatment location, the second treatment location distal to the first treatment location.

### Claim 24 (depends on 23)

The method of claim 23, wherein the second catheter, the neurovascular catheter, and the sheath form an extended contiguous lumen.

### Claim 25 (depends on 24)

The method of claim 24, wherein applying suction from the single source of suction delivers suction to a distal end of the second catheter through the extended contiguous lumen.

### Claim 26

A neurovascular catheter, comprising:
an elongate control element configured to advance the catheter, the control element comprising a flat ribbon, a proximal end region, and a distal end region; and
a distal luminal portion extending along a longitudinal axis having a proximal end region coupled to the distal end region of the control element,
wherein the distal luminal portion has a side wall defining a single, inner lumen extending between a proximal opening into the inner lumen at the proximal end region and a distal opening from the central lumen at the distal end region, the side wall comprising:
a tubular inner liner having an outer surface coated with a compound suitable for bonding;
a reinforcement structure that is a helical coil bonded to the coated outer surface of the tubular inner liner; and
an outer jacket surrounding the helical coil,
wherein the distal end region of the elongate control element is coupled to the proximal end region of the distal luminal portion sandwiched between layers of the side wall,
wherein the proximal end region of the distal luminal portion where the distal end region of the elongate control element is coupled has a step-up in outer diameter compared to an outer diameter of the distal luminal portion distal to the proximal end region of the distal luminal portion.

### Claim 27 (depends on 26)

A neurovascular catheter as in claim 26, wherein a distal end of the flat ribbon has a feature that facilitates a mechanical joint during a weld.

### Claim 28 (depends on 27)

A neurovascular catheter as in claim 27, wherein the feature comprises a textured surface, protruding feature, or cut-out feature.

### Claim 29 (depends on 26)

Neurovascular catheter as in claim 26, wherein the distal luminal portion and the flat ribbon are joined by a weld bond, a mechanical bond, or an adhesive bond.

### Claim 30 (depends on 26)

A neurovascular catheter as in claim 26, wherein a distal end of the flat ribbon is skived, ground or cut.

### Claim 31 (depends on 26)

A neurovascular catheter as in claim 26, wherein a region of overlap between a distal end of the ribbon and the proximal end region of the distal luminal portion is at least about 1 cm.

### Claim 32 (depends on 26)

A neurovascular catheter as in claim 26, wherein the distal luminal portion has a transition section near where the distal luminal portion couples to the elongate control element.

### Claim 33 (depends on 32)

A neurovascular catheter as in claim 32, wherein the transition section has an angled cut.

### Claim 34 (depends on 33)

A neurovascular catheter as in claim 33, wherein the proximal opening is formed within the transition section and the proximal end region of the distal luminal portion is coupled to the distal end region of the control element adjacent the transition section.

### Claim 35 (depends on 26)

A neurovascular catheter as in claim 26, wherein a proximal end of the distal luminal portion is angled in an oblique manner relative to a longitudinal axis of the catheter.

### Claim 36 (depends on 35)

A neurovascular catheter as in claim 35, wherein the proximal end and the proximal opening into the lumen are at an angle other than 90 degrees to the longitudinal axis of the catheter.

### Claim 37 (depends on 26)

A neurovascular catheter as in claim 26, wherein the outer jacket is formed from a plurality of tubular segments positioned coaxially about the helical coil.

### Claim 38 (depends on 37)

A neurovascular catheter as in claim 37, wherein a proximal one of the plurality of tubular segments has a durometer of at least about 60D and a distal one of the plurality of tubular segments has a durometer of no more than about 35D.

### Claim 39 (depends on 26)

A neurovascular catheter as in claim 26, wherein the tubular liner comprises polytetrafluoroethylene.

### Claim 40 (depends on 26)

A neurovascular catheter as in claim 26, wherein the helical coil comprises a shape memory material.

### Claim 41 (depends on 40)

A neurovascular catheter as in claim 40, wherein the helical coil comprises Nitinol.

### Claim 42 (depends on 37)

A neurovascular catheter as in claim 37, wherein the outer jacket is formed from at least five discrete tubular segments.

### Claim 43 (depends on 37)

A neurovascular catheter as in claim 37, wherein the outer jacket is formed from more than five discrete tubular segments.

### Claim 44 (depends on 43)

A neurovascular catheter as in claim 43, wherein a difference in durometer between a proximal one of the tubular segments and a distal one of the tubular segments is at least about 20D.

### Claim 45 (depends on 44)

A neurovascular catheter as in claim 44, wherein the difference is at least about 30D.

### Claim 46 (depends on 26)

A neurovascular catheter as in claim 26, wherein the distal luminal portion is non-expandable.

### Claim 47 (depends on 26)

A neurovascular catheter as in claim 26, wherein a proximal end of the elongate flexible control element is coupled to a tab.

### Claim 48 (depends on 26)

A neurovascular catheter as in claim 26, wherein the control element further comprises a reversible coupling feature configured to engage with a component used with the catheter to aid in organization of the catheter and the component.

### Claim 49 (depends on 26)

A neurovascular catheter as in claim 26, wherein a distal end of the tubular segment is angled in an oblique manner relative to the longitudinal axis.

### Claim 50 (depends on 26)

A neurovascular catheter as in claim 26, wherein the flat ribbon has a rectangular cross-sectional dimension that is wider than it is thick.

### Claim 51 (depends on 26)

A neurovascular catheter as in claim 26, wherein a maximum cross-sectional dimension of the flat ribbon is 0.025″.

### Claim 52 (depends on 26)

A neurovascular catheter as in claim 26, wherein a length of the distal luminal portion is sufficient to reach from a transfemoral access site to a middle cerebral artery so that the proximal end region of the distal luminal portion remains outside the aortic arch.