# US 12,179,010 B2 · Systems and methods for reducing pressure at an outflow of a duct

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- Number: US 12,179,010 B2
- Document ID: US12179010B2
- Status: Granted
- Kind: B2
- Application number: 18/368,225
- Filed: 2023-09-14
- Published: 2024-02-22
- Granted: 2024-12-31
- Earliest claimed: 2017-03-02
- Assignees: White Swell Medical Ltd
- Applicants: White Swell Medical Ltd
- Inventors: Yaacov Nitzan; Menashe Yacoby; Sagi Raz; Shani Chen; Or Inbar
- Web page: https://patentgrep.com/patent/US12179010B2

## CPC

- A61B 17/12136: {Balloons}
- A61M 60/50: Details relating to control
- A61B 5/02152: {specially adapted for venous pressure}
- A61B 17/12045: {double occlusion, e.g. during anastomosis}
- A61B 17/12109: {in a blood vessel}
- A61M 60/13: by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
- A61M 60/135: inside a blood vessel, e.g. using grafting
- A61M 60/237: the blood flow through the rotating member having mainly axial components, e.g. axial flow pumps
- A61M 60/30: Medical purposes thereof other than the enhancement of the cardiac output
- A61M 60/414: transmitted by a rotating cable, e.g. for blood pumps mounted on a catheter
- A61M 60/833: Occluders for preventing backflow
- A61B 2017/00022: {Sensing or detecting at the treatment site}
- A61B 2017/00026: {Conductivity or impedance, e.g. of tissue}
- A61B 2017/00044: {Sensing electrocardiography, i.e. ECG}
- A61B 2017/00526: {Methods of manufacturing}
- A61B 2090/064: {for measuring force, pressure or mechanical tension}
- A61M 25/0108: {using radio-opaque or ultrasound markers}
- A61M 60/279: Peristaltic pumps, e.g. roller pumps
- A61M 2202/0405: Lymph
- A61M 2205/3303: Using a biosensor
- A61M 2205/3306: Optical measuring means
- A61M 2205/3331: Pressure; Flow
- A61M 2205/3379: Masses, volumes, levels of fluids in reservoirs, flow rates
- A61M 2230/06: Heartbeat rate only
- A61M 2230/30: Blood pressure (A61M2230/04 takes precedence)
- A61M 2230/42: Rate
- A61M 2230/63: Motion, e.g. physical activity
- 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

Various systems and methods are provided for reducing pressure at an outflow of a duct such as the thoracic duct or the lymphatic duct. A catheter system can include a catheter shaft configured to be at least partially implantable within a patient's vein, a flexible membrane attached to the catheter shaft, the flexible membrane being a collapsible, tube-like member having a lumen extending therethrough, and a single selectively deployable restriction member formed over a portion of the flexible membrane at substantially a midpoint between a proximal end of the flexible membrane and a distal end of the flexible membrane, the restriction member being configured to control a size of the lumen so as to direct a controlled volume of fluid from an upstream side of the restriction member to a downstream side the restriction member.

## Claims

### Claim 1

A method of reducing pressure at an outflow of a duct, the method comprising:
positioning a device comprising a catheter in a blood vessel near an output of a duct, the catheter comprising a distal portion having an inlet and an outlet, the device comprising a selectively deployable restrictor a portion of which defines a tapered lumen;
deploying the restrictor; and
pumping blood through the tapered lumen into an impeller assembly of the device to thereby lower pressure near the output of the duct;
wherein the restrictor is mounted around the impeller assembly.

### Claim 2 (depends on 1)

The method of claim 1, wherein the restrictor occludes the blood vessel but for the lumen therethrough.

### Claim 3 (depends on 1)

The method of claim 1, wherein the vessel is an internal jugular vein, a subclavian vein, or an innominate vein.

### Claim 4 (depends on 1)

The method of claim 1, wherein the device comprises a second restrictor attached to a distal end of said device and the method further comprises positioning the second restrictor inside the blood vessel.

### Claim 5 (depends on 4)

The method of claim 4, wherein the restrictor and the second restrictor are positioned separately inside the blood vessel.

### Claim 6 (depends on 5)

The method of claim 5, wherein the method further comprises deploying the second restrictor.

### Claim 7 (depends on 6)

The method of claim 6, wherein the method comprises deploying the restrictor and second restrictor simultaneously.

### Claim 8 (depends on 6)

The method of claim 6, wherein the method comprises deploying the restrictor and second restrictor separately.

### Claim 9 (depends on 6)

The method of claim 6, wherein deploying the restrictor and second restrictor produces two occlusions within blood vessel.

### Claim 10 (depends on 9)

The method of claim 9, wherein the two occlusions define a low pressure zone between the first and second restrictors within a portion of the blood vessel.

### Claim 11 (depends on 1)

The method of claim 1, wherein the distal portion of the catheter comprises the impeller assembly with an impeller disposed therein.

### Claim 12 (depends on 11)

The method of claim 11, wherein the impeller assembly comprises the inlet and the outlet.

### Claim 13 (depends on 12)

The method of claim 12, wherein the device further comprises an elongate driveshaft extending proximally from the impeller, and wherein blood flows out of the impeller assembly via the outlet along the side of the impeller assembly.

### Claim 14 (depends on 1)

The method of claim 1, wherein at least a portion of the impeller is distal to the restrictor.

### Claim 15 (depends on 1)

The method of claim 1, further comprising activating the impeller inside the blood vessel thereby directing fluid by the tapered surface of the restrictor into the inlet, through the assembly and out the outlet.

### Claim 16 (depends on 1)

The method of claim 1, wherein the catheter comprises a diameter of between 9 and 15 Fr.

### Claim 17 (depends on 1)

The method of claim 1, wherein the restrictor comprises an inflatable balloon and the method further comprises inflating the balloon when the device is positioned in the blood vessel.

### Claim 18 (depends on 1)

The method of claim 1, wherein, when the restrictor is deployed, a second portion of the restrictor is not tapered.
