# US 11,998,224 B2 · Clot retrieval system

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- Number: US 11,998,224 B2
- Document ID: US11998224B2
- Status: Granted
- Kind: B2
- Application number: 17/713,162
- Filed: 2022-04-04
- Published: 2022-07-21
- Granted: 2024-06-04
- Earliest claimed: 2014-05-18
- Assignees: Legacy Ventures LLC
- Applicants: Legacy Ventures LLC
- Inventors: Arthur John Ulm, III
- Web page: https://patentgrep.com/patent/US11998224B2

## CPC

- 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 6/12: Arrangements for detecting or locating foreign bodies
- A61M 25/0108: {using radio-opaque or ultrasound markers}
- A61B 2017/00526: {Methods of manufacturing}
- A61B 2017/00867: {shape memory effect}
- A61B 2017/2212: {having a closed distal end, e.g. a loop}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- 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

A platform of devices for removing obstructions and other objects within a blood vessel or other interior lumen of an animal is provided. The system may be deployed in the lumen from a catheter(s) and the system includes a proximal hub, and a distal basket comprised of a plurality of cells. A number of different baskets designs are disclosed. Methods of manufacturing such baskets out of a single tube of a memory metal without the need for any welding, and methods of use are also disclosed.

## Claims

### Claim 1

A system for removing objects from an interior lumen of an animal, the system comprising:
a pull wire having a proximal end and a distal end;
a distal body attached to the pull wire, the distal body comprising an interior, a perimeter, a proximal end, a distal end, a distal body length extending from the proximal end to the distal end, a proximal junction forming the proximal end of the distal body, a plurality of proximal strips, a basket comprised of a plurality of cells formed by a plurality of basket strips, and a distal junction forming a distal end of the basket, the basket comprising a basket interior, each proximal strip having a distal end attached to a cell and a proximal end, the proximal ends of the proximal strips converging at the proximal junction, the distal body having a relaxed state wherein the distal body has a first height and a first width, and a collapsed state wherein the distal body has a second height and a second width, the second height less than the first height, the second width less than the first width,
wherein the distal body, in the relaxed state, comprises a distal tapered region in which the distal body height and width decrease as the basket approaches the distal junction,
wherein, in the relaxed state, the basket comprises a first pair of x-ray markers located approximately the same distance from the proximal junction and approximately 180 degrees relative to each other, wherein the basket further comprises a second pair of x-ray markers located distally relative to, and approximately 90 degrees relative to, the first pair of x-ray markers, the x-ray markers in the second pair of x-ray markers located approximately the same distance from the proximal junction, the x-ray makers more visible under x-ray as compared to the basket strips when the distal body is located in a cranial blood vessel inside the body of a human and the x-ray is taken from outside the human's body,
wherein the proximal end of a first proximal strip is located at least about 65 degrees relative to the distal end of the first proximal strip, wherein the proximal end of a second proximal strip is located at least about 65 degrees relative to the distal end of the second proximal strip, and further wherein the first and second proximal strips intersect adjacent and distal to the proximal junction.

### Claim 2 (depends on 1)

The system of claim 1, wherein, in the relaxed state, the basket interior is substantially hollow.

### Claim 3 (depends on 1)

The system of claim 1 further comprising a catheter having an interior, a proximal end leading to the interior and a distal end leading to the interior, the catheter comprised of a biocompatible polymeric material and configured to envelope the distal body when the distal body is in the collapsed state.

### Claim 4 (depends on 1)

The system of claim 1, wherein, the x-ray markers are comprised of a material different than the material forming the basket strips.

### Claim 5 (depends on 1)

The system of claim 1, wherein, in the relaxed state, the distal body does not have another x-ray marker that is located approximately the same distance from the proximal junction as the first pair of x-ray markers and the distal body does not have another x-ray marker that is located approximately the same distance from the proximal junction as the second pair of x-ray markers.

### Claim 6 (depends on 1)

The system of claim 1 wherein the basket strips are comprised of a memory metal.

### Claim 7 (depends on 1)

The system of claim 1, wherein the x-ray markers of the first pair of x-ray markers are configured to contact each other when an exterior, external compressive force is exerted on an x-ray marker of the first pair of x-ray marker when the distal body is in the relaxed state.

### Claim 8 (depends on 1)

The system of claim 1 wherein the proximal junction is located approximately in the center of the first height and first width in the relaxed state.

### Claim 9 (depends on 1)

The system of claim 1, wherein the distal body further comprises a lead wire extending distally from the distal junction, the lead wire having a length of from about 3 mm to about 10 mm.

### Claim 10 (depends on 1)

The system of claim 1 wherein the basket further comprises a plurality of distal cells, each distal cell having a proximal crown attached to another cell of the basket and pointing generally in the proximal direction and a distal crown pointing generally in the distal direction and attached to the distal junction.

### Claim 11 (depends on 10)

The system of claim 10 wherein the basket further comprises a first pair of enlarged cells, each of the first pair of enlarged cells having a center, the centers of the first pair of enlarged cells located approximately the same distance from the proximal junction and approximately 180 degrees relative to each other, and further wherein the basket further comprises a second pair of enlarged cells, each of the second pair of enlarged cells having a center, the centers of the second pair of enlarged cells located distally relative to the first pair of x-ray markers and the centers of the first pair of enlarged cells, and approximately 90 degrees relative to the centers of the first pair of enlarged cells, the centers of the enlarged cells in the second pair of enlarged cells located approximately the same distance from the proximal junction, wherein each cell of the basket comprises a length parallel to the distal body length, and further wherein in the relaxed state, each of the enlarged cells is longer than each of the distal cells.

### Claim 12 (depends on 11)

The system of claim 11 wherein the first pair of x-ray markers is adjacent to the first pair of enlarged cells and the second pair of x-ray markers is adjacent to the second pair of enlarged cells.

### Claim 13 (depends on 11)

The system of claim 11, wherein, in the relaxed state, the basket interior is substantially hollow and further wherein the first pair of enlarged cells are located on opposite sides of the basket and substantially aligned such that the first pair of enlarged cells and substantially hollow interior create a void extending from one of the opposite sides through the substantially hollow interior to the other of the opposite sides.

### Claim 14 (depends on 1)

The system of claim 1 wherein the distal body, in the relaxed state comprises a proximal tapered region in which the distal body height and width decrease as the proximal strips approach the proximal junction.

### Claim 15 (depends on 1)

A method of removing a blood clot from a blood vessel of an animal the method comprising the steps of:
a) providing the system of claim 1, wherein the distal body is positioned in a catheter;
b) positioning the system in the blood vessel;
c) deploying the distal body from the distal end of the catheter;
d) allowing the height and width of the distal body to increase;
e) irradiating the distal body with x-rays;
f) moving the blood clot into the basket interior; and
g) moving the distal body proximally out of the blood vessel.

### Claim 16

A system for removing objects from an interior lumen of an animal, the system comprising:
a pull wire having a proximal end and a distal end;
a distal body attached to the pull wire, the distal body comprising an interior, a perimeter, a proximal end, a distal end, a distal body length extending from the proximal end to the distal end, a proximal junction forming the proximal end of the distal body, a plurality of proximal strips, a basket comprised of a plurality of cells formed by a plurality of basket strips, and a distal junction forming a distal end of the basket, the basket comprising a basket interior, each proximal strip having a distal end attached to a cell and a proximal end, the proximal ends of the proximal strips converging at the proximal junction, the distal body having a relaxed state wherein the distal body has a first height and a first width, and a collapsed state wherein the distal body has a second height and a second width, the second height less than the first height, the second width less than the first width,
wherein the distal body, in the relaxed state, comprises a distal tapered region in which the distal body height and width decrease as the basket approaches the distal junction,
wherein, in the relaxed state, the basket comprises a first pair of x-ray markers located approximately the same distance from the proximal junction and approximately 180 degrees relative to each other, the x-ray makers more visible under x-ray as compared to the basket strips when the distal body is located in a cranial blood vessel inside the body of a human and the x-ray is taken from outside the human's body,
wherein the proximal end of a first proximal strip is located at least about 65 degrees relative to the distal end of the first proximal strip, wherein the proximal end of a second proximal strip is located at least about 65 degrees relative to the distal end of the second proximal strip, and further wherein the first and second proximal strips intersect adjacent and distal to the proximal junction,
wherein the basket further comprises a plurality of distal cells having a proximal crown attached to another cell of the basket and pointing generally in the proximal direction and a distal crown pointing generally in the distal direction and attached to the distal junction,
wherein the basket further comprises a first pair of enlarged cells, each of the first pair of enlarged cells having a center, the centers of the first pair of enlarged cells located approximately the same distance from the proximal junction and approximately 180 degrees relative to each other,
wherein each cell of the basket comprises a length parallel to the distal body length, and further wherein in the relaxed state, each of the enlarged cells is longer than each of the distal cells, and
further wherein the first pair of x-ray markers is adjacent to the first pair of enlarged cells.

### Claim 17 (depends on 16)

The system of claim 16, wherein, in the relaxed state, the basket interior is substantially hollow.

### Claim 18 (depends on 16)

The system of claim 16 further comprising a catheter having an interior, a proximal end leading to the interior and a distal end leading to the interior, the catheter comprised of a biocompatible polymeric material and configured to envelope the distal body when the distal body is in the collapsed state.

### Claim 19 (depends on 16)

The system of claim 16, wherein, the x-ray markers are comprised of a material different than the material forming the basket strips.

### Claim 20 (depends on 16)

The system of claim 16, wherein, in the relaxed state, the distal body does not have another x-ray marker that is located approximately the same distance from the proximal junction as the first pair of x-ray markers.

### Claim 21 (depends on 16)

The system of claim 16 wherein the basket strips are comprised of a memory metal.

### Claim 22 (depends on 16)

The system of claim 16, wherein the x-ray markers of the first pair of x-ray markers are configured to contact each other when an exterior, external compressive force is exerted on an x-ray marker of the first pair of x-ray marker when the distal body is in the relaxed state.

### Claim 23 (depends on 16)

The system of claim 16 wherein the proximal junction is located approximately in the center of the first height and first width in the relaxed state.

### Claim 24 (depends on 16)

The system of claim 16, wherein the distal body further comprises a lead wire extending distally from the distal junction, the lead wire having a length of from about 3 mm to about 10 mm.

### Claim 25 (depends on 16)

The system of claim 16, wherein, in the relaxed state, the basket interior is substantially hollow and further wherein the first pair of enlarged cells are located on opposite sides of the basket and substantially aligned such that the first pair of enlarged cells and substantially hollow interior create a void extending from one of the opposite sides through the substantially hollow interior to the other of the opposite sides.

### Claim 26 (depends on 16)

A method of removing a blood clot from a blood vessel of an animal the method comprising the steps of:
a) providing the system of claim 16, wherein the distal body is positioned in a catheter;
b) positioning the system in the blood vessel;
c) deploying the distal body from the distal end of the catheter;
d) allowing the height and width of the distal body to increase;
e) irradiating the distal body with x-rays;
f) moving the blood clot into the basket interior; and
g) moving the distal body proximally out of the blood vessel.