# US 2019/0167287 A1 · A clot retrieval system for removing occlusive clot from a blood vessel

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- Number: US 2019/0167287 A1
- Document ID: US20190167287A1
- Status: Published application
- Kind: A1
- Application number: 16/326,030
- Filed: 2017-08-03
- Published: 2019-06-06
- Earliest claimed: 2016-08-17
- Assignees: Neuravi Limited
- Applicants: Neuravi Limited
- Inventors: David VALE; Brendan CASEY; Brian FAHY; Kevin MCARDLE; Eamon BRADY; Jill AMSTUTZ; Maeve HOLIAN; Daniel KING; Michael GILVARRY
- Web page: https://patentgrep.com/patent/US20190167287A1

## CPC

- A61B 17/22032: {having inflatable gripping elements (balloon catheters A61M25/10)}
- 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)}
- A61F 2/95: Instruments specially adapted for placement or removal of stents or stent-grafts
- A61M 25/1002: {characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence)}
- A61M 25/1011: {Multiple balloon catheters}
- A61B 2017/22054: {with two balloons}
- A61B 2017/22062: {to be filled with liquid}
- A61B 2017/22067: {Blocking; Occlusion (A61B2017/22054 takes precedence)}
- A61B 2017/22069: {Immobilising; Stabilising}
- A61B 2017/22079: {with suction of debris}
- A61B 2217/005: with suction drainage system
- A61F 2002/9528: {for retrieval of stents}
- A61M 25/0032: {characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts}
- A61M 25/005: {with embedded materials for reinforcement, e.g. wires, coils, braids}
- A61M 25/1018: {Balloon inflating or inflation-control devices}
- A61M 25/1034: {Joining of shaft and balloon}
- A61M 2025/1013: {with concentrically mounted balloons, e.g. being independently inflatable}
- A61M 2025/1047: {having centering means, e.g. balloons having an appropriate shape}
- A61M 2025/1059: {having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties}
- A61M 2025/1065: {having a balloon which is inversely attached to the shaft at the distal or proximal end}
- A61M 2025/1079: {having radio-opaque markers in the region of the balloon}
- 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 2025/109: {having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow}
- A61M 2025/1093: {having particular tip characteristics}
- A61M 2205/0216: Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
- 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)
- 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

A clot capture catheter comprises an elongate tubular shaft having a proximal end, a distal end and an inflatable expansile member at the distal end. The expansile member is inflatable from a collapsed delivery configuration to an expanded configuration. In the expanded configuration, the expansile member extends to define a funnel shape having an enlarged distal clot entry mouth at the distal-most end of the catheter. In the expanded configuration, the expansile member may extend distally beyond the distalmost tip of the shaft. The expansile member may be integral with the distal tip of the catheter shaft.

## Claims

### Claim at position 1

1-74. (canceled)

### Claim 75

A clot capture catheter comprising an elongate tubular shaft having a proximal end, a distal end and an inflatable expansile member at the distal end, the expansile member being inflatable from a collapsed delivery configuration to an expanded configuration,
wherein, in the expanded configuration, the expansile member extends:
distally beyond the distalmost tip of the shaft and to at least the distalmost tip of the shaft; and
radially outwardly from the shaft at the distalmost tip of the shaft to define a mouth.

### Claim 76 (depends on 75)

The catheter of claim 75, wherein the expansile member comprises a balloon.

### Claim 77 (depends on 76)

The catheter of claim 76, wherein the balloon, in the expanded configuration is of funnel shape having an enlarged distal entry mouth and a narrower proximal end.

### Claim 78 (depends on 77)

The catheter of claim 77, wherein the balloon is integral to the distal tip of the catheter shaft, wherein the expansile member is formed from a polymeric tube which is inverted so that a distal junction between the balloon and the catheter shaft is located within the balloon.

### Claim 79 (depends on 77)

The catheter of claim 77, wherein the balloon comprises a proximal region, a distal region and a median region between the proximal and distal regions and wherein, in the expanded configuration, the distal region expands to a greater extent than the proximal region.

### Claim 80 (depends on 79)

The catheter of claim 79, wherein at least one region has a different wall thickness than at least one other region.

### Claim 81 (depends on 79)

The catheter of claim 79, wherein the expansile member comprises:
a proximal neck and a distal neck, the proximal neck having a first thickness, and being connected to the catheter shaft proximal of the distal end of the catheter,
a proximal portion of the expansile member comprising a second thickness,
a distal portion of the expansile member comprising a third thickness, and
the distal neck, which is inverted and joined to the distal end of the catheter shaft, comprising a fourth thickness.

### Claim 82 (depends on 81)

The catheter of claim 81, further comprising a band between the proximal and distal regions of the expansile member, the band having a greater wall thickness than the wall thickness of the proximal and/or distal regions to create a relatively non-expansile region such that the expansile member preferentially inflates proximal and distal of the band to provide a funnel shape profile.

### Claim 83 (depends on 82)

The catheter of claim 82, wherein at least one of the regions is reinforced to limit the expansion of that region.

### Claim 84 (depends on 83)

The catheter of claim 83, wherein the proximal region comprises a reinforcement, wherein the reinforcement comprises ribs, wherein the ribs extend axially and/or radially along at least a portion of the proximal region.

### Claim 85 (depends on 75)

The catheter of claim 75, wherein the expansile member extends beyond the distal tip of the shaft for a distance of from 0.5 mm to 3.5 mm;
wherein the catheter shaft comprises a main inner lumen, and an inflation lumen for inflating the expansile member.

### Claim 86 (depends on 85)

The catheter of claim 85, wherein the inflation lumen and the catheter lumen are concentric.

### Claim 87 (depends on 85)

The catheter of claim 85, wherein a distal portion of the shaft comprises a first amorphous elastomeric polymer and the inflatable expansile member comprises a second amorphous elastomeric polymer which is different than the first amorphous elastomeric polymer.

### Claim 88 (depends on 75)

The catheter of claim 75, further comprising an radiopaque expansile marker band at or adjacent to the expansile member, wherein the marker band is located beneath the expansile member, wherein the marker band is of generally tubular shape having axially extending slots which are configured to facilitate expansion of the marker.

### Claim 89 (depends on 75)

The catheter of claim 75, further comprising two to more expansile members, wherein at least some of the expansile members have differing compliance, and wherein inflatable balloon members mounted on the distal section of the catheter comprise an inner balloon member positioned within an outer balloon.

### Claim 90 (depends on 75)

The catheter of claim 75, wherein the inflatable member is inverted and joined to the catheter shaft at a proximal joint area and wherein the shaft comprises multiple layers, including an outer sleeve, a middle layer, an inner liner, and a reinforcing braid or coil,
wherein the proximal end of the inflatable member is joined to the elongate shaft at proximal joint area and the other end of the inflatable member is inverted and joined to the middle layer at a junction such that the middle section of a generally tubular polymer member that forms the expansile member is positioned at the distal end of the catheter, and the portion of the tubular polymer member that lies between the junction and the middle section is joined to the distal section of the catheter shaft.

### Claim 91 (depends on 75)

The catheter of claim 75, wherein a strip of material is mounted over the expansile member and joined proximally to the catheter body and the distal end of the material strip is bonded to an atraumatic distal tip of the catheter.

### Claim 92 (depends on 91)

The catheter of claim 91, wherein a plurality of material strips are positioned radially around the balloon.

### Claim 93

A clot capture procedure, comprising:
advancing a clot capture catheter towards a clot, the clot capture catheter comprising an inflatable member at the distalmost tip of the clot capture catheter and an inflatable member in a collapsed configuration;
inflating the inflatable member at the distal tip of the clot capture catheter so that the inflatable member extends outwardly from the distalmost tip of the clot capture catheter to the vessel wall;
drawing the clot into the clot capture catheter;
deflating the inflatable member; and
withdrawing the clot capture catheter.

### Claim 94

A clot capture procedure, comprising:
advancing a clot capture catheter through the vasculature to a position proximal of the target clot in a vessel, the clot capture catheter comprising an inflatable member at the distalmost tip of the catheter and an inflatable member in a collapsed configuration;
crossing the clot with a microcatheter;
advancing a clot capture device through the microcatheter to the site of the clot;
retracting the microcatheter to deploy the clot capture device at least partially beneath the clot;
inflating the expansile member of the clot capture catheter to slow or stop flow in the vessel;
retracting the clot capture device proximally towards the clot capture catheter;
connecting a syringe or pump to the proximal end of catheter and aspirating to reverse blood flow in the vessel;
retracting the clot capture device and captured clot under aspiration into the mouth of the clot capture catheter;
continuing to retract the clot capture device under aspiration through and out of the clot capture catheter; and
discontinuing aspiration and deflating the expansile member in order to restore blood flow to vessel.
