# US 11,305,094 B2 · Rapid aspiration thrombectomy system and method

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- Number: US 11,305,094 B2
- Document ID: US11305094B2
- Status: Granted
- Kind: B2
- Application number: 17/152,575
- Filed: 2021-01-19
- Published: 2021-05-13
- Granted: 2022-04-19
- Earliest claimed: 2015-02-04
- Assignees: Route 92 Medical, Inc.
- Applicants: Route 92 Medical, Inc.
- Inventors: Michi E. Garrison; Tony M. Chou; Scott D. Wilson
- Web page: https://patentgrep.com/patent/US11305094B2

## CPC

- A61M 25/0102: {Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod}
- 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 1/84: {Drainage tubes; Aspiration tips (for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32)}
- A61M 5/007: {for contrast media}
- A61M 25/0043: {characterised by structural features}
- A61M 25/0054: {with regions for increasing flexibility}
- A61M 25/0067: {characterised by the distal end, e.g. tips (A61M25/0054, A61M25/04 take precedence; balloon catheters A61M25/10)}
- A61M 25/01: Introducing, guiding, advancing, emplacing or holding catheters (A61M25/10 takes precedence)
- A61M 25/0108: {using radio-opaque or ultrasound markers}
- A61M 25/0662: {Guide tubes}
- A61M 25/10: Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00})
- A61M 29/00: Dilators with or without means for introducing media, e.g. remedies
- A61B 2017/22038: {with a guide wire}
- A61B 2017/22079: {with suction of debris}
- A61B 2017/2212: {having a closed distal end, e.g. a loop}
- A61B 2217/005: with suction drainage system
- A61M 25/0074: {Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable}
- A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)}
- A61M 2025/0019: {Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement}
- 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 2025/1084: {having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands}
- A61M 2210/0693: Brain, cerebrum
- 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)

## Abstract

An intravascular access system for facilitation of intraluminal medical procedures within the neurovasculature through an access sheath. The system includes an aspiration or support catheter having a flexible, distal luminal portion having an inner diameter defining a lumen extending between a proximal opening at a proximal end of the luminal portion and a distal opening at a distal end of the luminal portion. The catheter has a rigid spine coupled to at least the proximal end of the luminal portion and extending proximally therefrom. The system includes a dilator having a flexible, distal dilator portion sized to be received within the lumen of the luminal portion. Associated systems, devices, and methods of use are also described.

## Claims

### Claim 1

An intravascular access catheter for advancing a medical device for intraluminal medical procedures within the neurovasculature, comprising:
a flexible elongate body having a proximal end, a distal end, and a single lumen extending along a longitudinal axis between the proximal end and the distal end, the flexible elongate body comprising a plurality of regions including a tip region, wherein at least one of the plurality of regions of the flexible elongate body are comprised of unreinforced polymer, the tip region having a taper and a flexibility sufficient to navigate distal to a petrous portion of an internal carotid artery, and wherein the distal end defines a distal opening from the single lumen having a maximum inner diameter of 0.024″, the longitudinal axis extending through the distal opening;
a first marker disposed at the distal end of the flexible elongate body; and
a proximal extension extending proximally and coaxially from the proximal end of the flexible elongate body, the proximal extension comprising a metal hypotube having a lumen communicating with the single lumen of the flexible elongate body, wherein the proximal extension is formed of one or more additional materials different from the metal of the hypotube.

### Claim 2 (depends on 1)

The intravascular access catheter of claim 1, wherein the unreinforced polymer is Pebax.

### Claim 3 (depends on 1)

The intravascular access catheter of claim 1, wherein the plurality of regions of the flexible elongate body comprises three regions.

### Claim 4 (depends on 3)

The intravascular access catheter of claim 3, wherein the three regions comprise a proximal region, an intermediate region, and the tip region.

### Claim 5 (depends on 4)

The intravascular access catheter of claim 4, wherein a portion of the tip region of the flexible elongate body is shapeable by a user.

### Claim 6 (depends on 4)

The intravascular access catheter of claim 4, wherein the taper of the tip region tapers distally from a first outer diameter to a second smaller outer diameter.

### Claim 7 (depends on 6)

The intravascular access catheter of claim 6, wherein the tip region has a durometer of no more than 35D and the proximal region has a durometer of 72D.

### Claim 8 (depends on 6)

The intravascular access catheter of claim 6, further including a second marker disposed at a proximal end of the taper.

### Claim 9 (depends on 6)

The intravascular access catheter of claim 6, wherein the taper of the tip region tapers over a length between 1.5 cm and 3 cm.

### Claim 10 (depends on 9)

The intravascular access catheter of claim 9, wherein the proximal region and the intermediate region have a constant outer diameter.

### Claim 11 (depends on 1)

The intravascular access catheter of claim 1, wherein the one or more additional materials of the proximal extension is a polymer.

### Claim 12 (depends on 11)

The intravascular access catheter of claim 11, wherein the polymer of the proximal extension is Pebax.

### Claim 13 (depends on 12)

The intravascular access catheter of claim 12, wherein the durometer of the Pebax is 72D.

### Claim 14 (depends on 1)

The intravascular access catheter of claim 1, further including a hub at a proximal end of the proximal extension, the hub includes a lumen in fluid communication with the lumen of the proximal extension.

### Claim 15 (depends on 1)

The intravascular access catheter of claim 1, wherein the single lumen of the flexible elongate body is sized to receive a guidewire between 0.014″ and 0.018″ in diameter.

### Claim 16 (depends on 15)

The intravascular access catheter of claim 15, wherein an outer diameter of the flexible elongate body is 0.003″-0.010″ smaller than an inner diameter of a catheter it is used to advance.

### Claim 17 (depends on 16)

The intravascular access catheter of claim 16, wherein the inner diameter of the catheter that the intravascular access catheter is used to advance is 0.088″.

### Claim 18 (depends on 1)

The intravascular access catheter of claim 1, wherein the proximal extension has an outer diameter that is substantially similar to an outer diameter of the flexible elongate body.

### Claim 19 (depends on 1)

The intravascular access catheter of claim 1, wherein one of at least two of the plurality of regions of the flexible elongate body has a different durometer from a second one of the at least two of the plurality of regions.

### Claim 20 (depends on 1)

The intravascular access catheter of claim 1, wherein the single lumen of the flexible elongate body and the lumen of the proximal extension form a single contiguous lumen through the catheter.

### Claim 21 (depends on 1)

A system comprising the intravascular access catheter of claim 1 and further comprising a second catheter, the second catheter comprising:
a flexible, distal luminal portion having an inner diameter defining a lumen extending between a proximal opening at a proximal end of the luminal portion and a distal opening at a distal end of the luminal portion; and
a control element extending proximally from a point of coupling adjacent the proximal opening,
wherein the control element is configured with sufficient stiffness to control movement of the second catheter, wherein the flexible, distal luminal portion has an outer diameter at the point of coupling that is larger than an outer diameter of the control element at the point of coupling.

### Claim 22 (depends on 21)

The system of claim 21, wherein the access catheter is configured to insert into the lumen of the second catheter such that a distal end region of the plurality of regions of the flexible elongate body extends distally beyond the distal end of the luminal portion of the second catheter.

### Claim 23 (depends on 22)

The system of claim 22, wherein the distal end region of the flexible elongate body of the access catheter is the tip region having the taper.

### Claim 24 (depends on 23)

The system of claim 23, wherein the access catheter has an additional visual marker on a proximal end of the taper.

### Claim 25 (depends on 22)

The system of claim 22, wherein a distance between the distal opening of the flexible elongate body and a proximal opening of the proximal extension is sufficient to allow the distal end region of the flexible elongate body to be positioned within the neurovasculature while a proximal end region of the proximal extension is grasped by a user.

### Claim 26 (depends on 1)

The catheter of claim 1, wherein the plurality of regions each comprises a material or material combination providing a different flexibility.

### Claim 27 (depends on 1)

The catheter of claim 1, wherein the first marker is a radiopaque loaded polymer band.

### Claim 28 (depends on 1)

The catheter of claim 1, wherein at least two of the plurality of regions of the flexible elongate body are comprised of unreinforced polymer.

### Claim 29 (depends on 1)

The catheter of claim 1, wherein the distal opening is located at a distal-most end of the flexible elongate body.

### Claim 30 (depends on 29)

The catheter of claim 29, wherein the first marker is located at the distal-most end of the flexible elongate body.

### Claim 31 (depends on 29)

The catheter of claim 29, wherein the taper of the tip region tapers to the distal-most end of the flexible elongate body.

### Claim 32 (depends on 1)

The catheter of claim 1, wherein the distal opening of the flexible elongate body is the only distal opening in the flexible elongate body.

### Claim 33 (depends on 1)

The catheter of claim 1, wherein the one or more additional materials of the proximal extension is a polymer coating.
