# US 12,599,397 B2 · Thrombus removal systems and associated methods

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- Number: US 12,599,397 B2
- Document ID: US12599397B2
- Status: Granted
- Kind: B2
- Application number: 18/562,038
- Filed: 2022-05-19
- Published: 2024-07-18
- Granted: 2026-04-14
- Earliest claimed: 2021-05-19
- Assignees: Shifamed Holdings, LLC
- Applicants: Shifamed Holdings, LLC
- Inventors: Aadel Al-Jadda; Tom Saul; Kevin Muller; Amr Salahieh
- Web page: https://patentgrep.com/patent/US12599397B2

## CPC

- A61B 17/32037: {for removing obstructions from inner organs or blood vessels, e.g. for atherectomy}
- A61M 1/85: {with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants (for negative pressure wound therapy A61M1/92, A61M1/94; combined with tracheal tubes A61M16/0463; dental instruments with combined rinsing and aspirating A61C17/0208)}
- A61B 17/00234: {for minimally invasive surgery (A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence)}
- 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
- A61M 1/87: {Details of the aspiration tip, not otherwise provided for}
- A61M 3/0283: {with at least two inner passageways, a first one for irrigating and a second for evacuating (suction-irrigation systems A61M1/77; aspiration tips with fluid supply means A61M1/85; for negative pressure wound therapy A61M1/92)}
- A61B 2017/00238: {Type of minimally invasive operation (A61B2017/00805 takes precedence)}
- A61B 2017/00292: {mounted on or guided by flexible, e.g. catheter-like, means}
- 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
- A61B 2217/007: with irrigation system
- A61M 2206/10: Flow characteristics
- 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

The present technology relates to systems and methods for removing a thrombus from a blood vessel of a patient. In some embodiments, the present technology is directed to systems including an elongated catheter having a distal portion configured to be positioned within the blood vessel of the patient, a proximal portion configured to be external to the patient, and a lumen extending therebetween. The system can also include a fluid delivery mechanism coupled with a fluid lumen and configured to apply fluid to at least partially fragment the thrombus, and an aspiration mechanism fluidly coupled to an aspiration lumen and configured to aspirate the fragmented thrombus.

## Claims

### Claim 1

A thrombus removal system, comprising:
an elongated catheter device including:
a distal portion configured to be positioned within a blood vessel of a patient, the distal portion comprising an inner wall forming an aspiration lumen, and an outer wall, and a fluid lumen formed in a space between the inner wall and the outer wall;
a manifold formed near a distal end of the fluid lumen and the aspiration lumen, the manifold including a first fluid port and a second fluid port formed therein and surrounded by the manifold, the first fluid port having a first axis, the second fluid port having a second axis, wherein the first axis intersects with the second axis at a fluid intersection within the distal portion, the first fluid port and the second fluid port being configured to direct respective fluid streams along the first axis and the second axis that collide at the fluid intersection within the distal portion;
a proximal portion configured to be positioned external to the patient, the aspiration lumen extending from the distal portion to the proximal portion;
an aspiration mechanism positioned external to the patient and fluidly coupled with the aspiration lumen, the aspiration mechanism configured to reduce a pressure at the distal portion (a) to engage a thrombus therewith and/or (b) to draw the thrombus and/or thrombus fragments proximally; and
a fluid delivery mechanism configured to supply fluid through the fluid lumen.

### Claim 2 (depends on 1)

The system of claim 1 wherein the inner wall and the outer wall are concentrically arranged such that the fluid lumen is generally annular in cross-section.

### Claim 3 (depends on 1)

The system of claim 1, further comprising at least one fluid wall disposed in the space between the inner and outer walls, the at least one fluid wall forming the fluid lumen.

### Claim 4 (depends on 1)

The system of claim 1, wherein the manifold is formed from the inner wall and the outer wall.

### Claim 5 (depends on 1)

The system of claim 1, wherein the first fluid port and the second fluid port are formed within the inner wall of the manifold.

### Claim 6 (depends on 5)

The system of claim 5, wherein the inner wall has a first thickness in a first region within the manifold, and a second thickness proximal to the first region.

### Claim 7 (depends on 6)

The system of claim 6, wherein the first thickness is greater than the second thickness.

### Claim 8 (depends on 7)

The system of claim 7, wherein the first thickness is about twice that of the second thickness.

### Claim 9 (depends on 6)

The system of claim 6, wherein the first thickness ranges from 0.10 mm to 0.60 mm and the second thickness ranges from 0.20 mm to 0.70 mm.

### Claim 10 (depends on 6)

The system of claim 6, wherein the first thickness is selected to provide a generally laminar flow for the respective fluid streams.

### Claim 11 (depends on 1)

The system of claim 1, wherein a cross-sectional dimension of the first fluid port and the second fluid port varies along its length.

### Claim 12 (depends on 11)

The system of claim 11, wherein the first fluid port and the second fluid port are conical along their lengths.

### Claim 13 (depends on 12)

The system of claim 12, wherein a smallest dimension of the first fluid port and the second fluid port is positioned at a distal end of the two or more ports.

### Claim 14 (depends on 1)

The system of claim 1, wherein the manifold is configured to increase a flow rate of the fluid in the fluid lumen.

### Claim 15 (depends on 1)

The system of claim 1, wherein the manifold is configured to increase a pressure of the fluid in the fluid lumen.

### Claim 16 (depends on 1)

The system of claim 1, further comprising a funnel positioned at a distal end of the distal portion, the funnel being configured to engage with the thrombus.

### Claim 17 (depends on 16)

The system of claim 16, wherein the manifold is disposed proximally of the funnel.

### Claim 18 (depends on 16)

The system of claim 16, wherein the manifold is integrated into the funnel.
