# US 10,864,351 B2 · Methods and systems for treatment of acute ischemic stroke

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- Number: US 10,864,351 B2
- Document ID: US10864351B2
- Status: Granted
- Kind: B2
- Application number: 16/931,234
- Filed: 2020-07-16
- Published: 2020-11-05
- Granted: 2020-12-15
- Earliest claimed: 2013-12-23
- Assignees: Route 92 Medical, Inc.
- Applicants: Route 92 Medical, Inc.
- Inventors: Michi E. Garrison; Tony M. Chou
- Web page: https://patentgrep.com/patent/US10864351B2

## CPC

- A61M 25/0054: {with regions for increasing flexibility}
- 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 17/320758: {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 17/3417: {Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating (syringe needles A61M5/32; dilators A61M29/00)}
- A61F 2/013: {Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting}
- A61M 25/0023: {by the form of the lumen, e.g. cross-section, variable diameter}
- A61M 25/0041: {pre-formed, e.g. specially adapted to fit with the anatomy of body channels (urethral catheters A61F2/04)}
- A61M 25/0043: {characterised by structural features}
- A61M 25/0068: {Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure}
- A61M 25/01: Introducing, guiding, advancing, emplacing or holding catheters (A61M25/10 takes precedence)
- A61M 25/0662: {Guide tubes}
- A61M 29/00: Dilators with or without means for introducing media, e.g. remedies
- A61B 17/00: Surgical instruments, devices or methods (A61B18/00 takes precedence; dental tools A61C3/00; eye surgery A61F9/007; ear surgery A61F11/20)
- A61B 2017/00867: {shape memory effect}
- A61B 2017/00991: {Telescopic means}
- A61B 2017/22034: {for gripping the obstruction or the tissue part from inside}
- A61B 2017/22038: {with a guide wire}
- A61B 2017/22039: {eccentric}
- A61B 2017/22042: {Details of the tip of the guide wire}
- A61B 2017/22054: {with two balloons}
- A61B 2017/22062: {to be filled with liquid}
- A61B 2017/22067: {Blocking; Occlusion (A61B2017/22054 takes precedence)}
- A61B 2017/22072: {with an instrument channel, e.g. for replacing one instrument by the other}
- A61B 2017/22074: {the instrument being only slidable in a channel, e.g. advancing optical fibre through a channel}
- A61B 2017/22079: {with suction of debris}
- A61B 2017/22082: {after introduction of a substance}
- A61B 2017/22084: {stone- or thrombus-dissolving}
- A61B 2017/22094: {for crossing total occlusions, i.e. piercing}
- A61B 2017/2212: {having a closed distal end, e.g. a loop}
- A61B 2017/2215: {having an open distal end}
- A61B 2017/2217: {single wire changing shape to a gripping configuration}
- A61B 2017/320775: {Morcellators, impeller or propeller like means}
- A61B 2017/3484: {Anchoring means, e.g. spreading-out umbrella-like structure}
- A61B 2017/3486: {Balloon}
- A61B 2090/062: {penetration depth}
- A61M 25/0053: {having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid}
- A61M 25/007: {Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked}
- A61M 2025/0004: {having two or more concentrically arranged tubes for forming a concentric catheter system}
- A61M 2025/0037: {characterized by lumina being arranged side-by-side}
- A61M 2025/0042: {Microcatheters, cannula or the like having outside diameters around 1 mm or less}
- A61M 2025/0175: {having telescopic features, interengaging nestable members movable in relations to one another}
- A61M 2025/0681: {Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube}
- A61M 2025/1052: {for temporarily occluding a vessel for isolating a sector}
- A61M 2210/12: Blood circulatory system
- 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)}
- 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

A system of devices for treating an artery includes an arterial access sheath adapted to introduce an interventional catheter into an artery and an elongated dilator positionable within the internal lumen of the sheath body. The system also includes a catheter formed of an elongated catheter body sized and shaped to be introduced via a carotid artery access site into a common carotid artery through the internal lumen of the arterial access sheath. The catheter has an overall length and a distal most section length such that the distal most section can be positioned in an intracranial artery and at least a portion of the proximal most section is positioned in the common carotid artery during use.

## Claims

### Claim 1

An aspiration catheter system comprising:
an access sheath comprising a tubular sheath body with a central lumen having an inner diameter, a proximal end and a distal opening,
and a connector operably connected with the sheath body and attachable to an aspiration line that connects to an aspiration source via the connector; and
a catheter comprising a distal portion and a proximal tether extending proximally from a point of attachment between the proximal tether and the distal portion, wherein the distal portion has a single inner lumen, and wherein the catheter is configured to extend from a femoral access site to a carotid artery,
wherein the catheter is configured to slide within the central lumen of the sheath body to change the relative position of the catheter within the central lumen and provide for at least a portion of the distal portion to extend outward from the distal opening of the sheath body such that an overlap region is formed between the catheter and the access sheath,
wherein an aspiration lumen is collectively formed by the single inner lumen of the catheter and the central lumen of the access sheath, and
wherein a proximal end region of the catheter comprises an inclined surface flaring outward in a proximal direction, wherein the inclined surface is formed in a thickened portion of the catheter wall that is sized to contact the inner diameter of the central lumen to provide sealing sufficient to transmit aspiration force to a distal opening of the catheter to capture a thrombus.

### Claim 2 (depends on 1)

The aspiration catheter system of claim 1, wherein the inclined surface is biased outward and compressible against the inner diameter of the sheath.

### Claim 3 (depends on 1)

The aspiration catheter systems of claim 1, wherein the access sheath has an outer diameter ranging from about 6 Fr to about 8 Fr and the inner diameter of the catheter is between about 0.058″ and about 0.072″ and wherein the inner diameter of the central lumen of the sheath body is between about 0.074″ and about 0.088″.

### Claim 4 (depends on 1)

The aspiration catheter system of claim 1, wherein the sheath body of the access sheath has a length from about 90 cm to about 120 cm.

### Claim 5 (depends on 1)

The aspiration catheter system of claim 1, further comprising the aspiration source comprising a syringe having a volume of at least 30 cc, and wherein a flow rate of at least about 321 mL/min is established when an aspiration pressure through the aspiration lumen is applied by the syringe.

### Claim 6 (depends on 1)

The aspiration catheter system of claim 1, wherein the catheter comprises a radiopaque marker near the proximal end region and a radiopaque marker near the distal opening.

### Claim 7 (depends on 1)

The aspiration catheter system of claim 1, wherein the point of attachment is positioned within a transition zone that bridges a flexibility of the proximal tether to a flexibility of the catheter.

### Claim 8 (depends on 7)

The aspiration catheter system of claim 7, wherein the proximal tether within the transition zone comprises a flattened distal end region.

### Claim 9 (depends on 7)

The aspiration catheter system of claim 7, wherein the proximal end region of the catheter within the transition zone comprises a reinforcement structure.

### Claim 10 (depends on 1)

The aspiration catheter system of claim 1, wherein the inclined surface forms a single compressible external surface feature.

### Claim 11 (depends on 1)

The aspiration catheter system of claim 1, wherein the proximal end region having the inclined surface has a substantially uniform inner diameter.

### Claim 12 (depends on 1)

The aspiration catheter system of claim 1, wherein the access sheath having the central lumen is a single-lumen access sheath.

### Claim 13 (depends on 1)

The aspiration catheter system of claim 1, wherein the inclined surface forms a sealing element positioned on the external surface of a proximal end of the catheter.

### Claim 14

An aspiration catheter system comprising:
an access sheath comprising a tubular sheath body with a central lumen having an inner diameter, a proximal end and a distal opening,
and a connector operably connected with the sheath body and attachable to an aspiration line that connects to an aspiration source via the connector; and
a catheter comprising a distal portion and a proximal tether extending proximally from a point of attachment between the proximal tether and the distal portion, wherein the distal portion has a single inner lumen, and wherein the catheter is configured to extend from a femoral access site to a carotid artery,
wherein the catheter is configured to slide within the central lumen of the sheath body to change the relative position of the catheter within the central lumen and provide for at least a portion of the distal portion to extend outward from the distal opening of the sheath body such that an overlap region is formed between the catheter and the access sheath,
wherein an aspiration lumen is collectively formed by the single inner lumen of the catheter and the central lumen of the access sheath, and
wherein a proximal end region of the catheter wall thickens to form an inclined surface that flares outward so as to increase the outer diameter of the proximal end region, the inclined surface being biased outward against the inner diameter of the sheath.

### Claim 15 (depends on 14)

The aspiration catheter system of claim 14, wherein the inclined surface forms a compressible external surface feature.

### Claim 16 (depends on 14)

The aspiration catheter system of claim 14, wherein the catheter comprises a radiopaque marker near the proximal end region and a radiopaque marker near the distal opening.

### Claim 17 (depends on 14)

The aspiration catheter system of claim 14, wherein the point of attachment is positioned within a transition zone that bridges a flexibility of the proximal tether to a flexibility of the catheter.

### Claim 18 (depends on 17)

The aspiration catheter system of claim 17, wherein the proximal tether within the transition zone comprises a flattened distal end region.

### Claim 19 (depends on 17)

The aspiration catheter system of claim 17, wherein the proximal end region of the catheter within the transition zone comprises a reinforcement structure.

### Claim 20 (depends on 18)

The aspiration catheter system of claim 18, further comprising the aspiration source comprising a syringe having a volume of at least 30 cc, and wherein a flow rate of at least about 321 mL/min is established when an aspiration pressure through the aspiration lumen is applied by the syringe.

### Claim 21 (depends on 18)

The aspiration catheter system of claim 18, wherein the inclined surface forms a single compressible external surface feature.

### Claim 22 (depends on 18)

The aspiration catheter system of claim 18, wherein the proximal end region having the inclined surface has a substantially uniform inner diameter.

### Claim 23 (depends on 18)

The aspiration catheter system of claim 18, wherein the access sheath having the central lumen is a single-lumen access sheath.

### Claim 24 (depends on 18)

The aspiration catheter system of claim 18, wherein the inclined surface forms a sealing element positioned on the external surface of a proximal end of the catheter.