# US 10,441,291 B2 · Devices and methods for treating acute kidney injury

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- Number: US 10,441,291 B2
- Document ID: US10441291B2
- Status: Granted
- Kind: B2
- Application number: 15/969,050
- Filed: 2018-05-02
- Published: 2018-09-06
- Granted: 2019-10-15
- Earliest claimed: 2016-05-04
- Assignees: RenalPro Medical, Inc.
- Applicants: Renalpro Medical, Inc.
- Inventors: Charles Char-Lin Koo; Tsung-Chun Lee; Wen-Pin Shih
- Web page: https://patentgrep.com/patent/US10441291B2

## CPC

- A61B 17/12036: {partial occlusion}
- A61B 6/12: Arrangements for detecting or locating foreign bodies
- A61B 6/484: {involving phase contrast X-ray imaging}
- A61B 17/12031: {complete occlusion}
- A61B 17/1204: {temporary occlusion}
- A61B 17/12045: {double occlusion, e.g. during anastomosis}
- A61B 17/12109: {in a blood vessel}
- A61B 17/12131: {characterised by the type of occluding device}
- A61B 17/12136: {Balloons}
- A61B 17/12172: {having a pre-set deployed three-dimensional shape (methods of manufacturing A61B2017/00526)}
- A61B 90/06: {Measuring instruments not otherwise provided for}
- A61M 5/007: {for contrast media}
- A61M 25/0108: {using radio-opaque or ultrasound markers}
- A61M 25/1011: {Multiple balloon catheters}
- A61M 60/13: by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
- A61M 60/295: Balloon pumps for circulatory assistance
- A61M 60/33: of kidneys
- A61M 60/427: the force acting on the blood contacting member being hydraulic or pneumatic
- A61M 60/531: using blood pressure data, e.g. from blood pressure sensors
- A61M 60/554: of blood pressure
- A61B 2017/00455: {Orientation indicators, e.g. recess on the handle}
- A61B 2090/063: {for measuring volume}
- A61B 2090/064: {for measuring force, pressure or mechanical tension}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61M 25/09: Guide wires
- A61M 25/1002: {characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence)}
- A61M 2025/0002: {with a pressure sensor at the distal end}
- A61M 2025/0073: {Tip designed for influencing the flow or the flow velocity of the fluid, e.g. inserts for twisted or vortex flow}
- A61M 2025/1052: {for temporarily occluding a vessel for isolating a sector}
- A61M 2025/1079: {having radio-opaque markers in the region of the balloon}
- A61M 2025/1095: {with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft}
- A61M 2205/0244: Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
- A61M 2205/0266: Shape memory materials
- A61M 2205/3327: Measuring
- A61M 2205/3331: Pressure; Flow
- A61M 2206/16: Rotating swirling helical flow, e.g. by tangential inflows
- A61M 2210/1082: Kidney
- A61M 2210/12: Blood circulatory system
- 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 catheter devices/systems and methods therefrom are described herein for treating acute kidney injury, especially the contrast-induced acute kidney injury wherein the devices may prevent the contrast dyes from entering into kidney and/or facilitate blood flow of kidney by said catheter system.

## Claims

### Claim 1

A device for preventing acute kidney injury from contrast agent introduced into vasculature of a subject, the device comprising:
a catheter shaft comprising proximal portion and a distal portion;
an occlusive element disposed on the proximal portion; and
at least one longitudinal position indication feature on the occlusive element,
wherein the occlusive element has an expanded configuration in which, when advanced into an abdominal aorta and positioned adjacent renal artery ostia of the subject, is sized to occlude the renal artery ostia while allowing blood flow over the catheter shaft, and
wherein the distal portion is configured to remain outside a body of the subject when the proximal portion is positioned adjacent renal artery ostia of the subject,
wherein the occlusive element comprises a first expandable member disposed on a first lateral side of the proximal portion and a second expandable member disposed on a second lateral side of the proximal portion, the first and second expandable members being disposed in parallel about the catheter shaft, and
wherein the first and second expandable members have an expanded configuration in which, when advanced into an abdominal aorta and positioned adjacent renal artery ostia of the subject, are sized to occlude the renal artery ostia while allowing blood flow over the catheter shaft.

### Claim 2 (depends on 1)

The device of claim 1, wherein the first expandable member and the second expandable member are in fluid communication with one another.

### Claim 3 (depends on 1)

The device of claim 1, wherein the first expandable member and the second expandable member are fluidly independent of one another.

### Claim 4 (depends on 1)

The device of claim 1, wherein the first expandable member and the second expandable member comprise a single balloon.

### Claim 5 (depends on 1)

The device of claim 1, wherein the first expandable member comprises a first balloon and the second expandable member comprises a second balloon.

### Claim 6 (depends on 1)

The device of claim 1, wherein the expanded configuration of the occlusive element is spherical, ellipsoidal, cylindrical, an n-sided prism, conical, pyramidal, butterfly-shaped, dumbbell-shaped, cigar-shaped, torpedo-shaped, or submarine-shaped.

### Claim 7 (depends on 1)

The device of claim 1, further comprising one or more position indication feature is disposed on the proximal portion of the catheter shaft adjacent the occlusive element.

### Claim 8 (depends on 7)

The device of claim 7, wherein the one or more position indication feature comprises one or more radio-opaque markers.

### Claim 9 (depends on 1)

The device of claim 1, wherein the at least one longitudinal position indication feature comprises at least one longitudinal radio-opaque marker.

### Claim 10 (depends on 9)

The device of claim 9, wherein the at least one longitudinal radio-opaque marker comprises a plurality of longitudinal radio-opaque markers.

### Claim 11 (depends on 1)

The device of claim 1, wherein the at least one longitudinal position indication feature is configured to form at least one straightened section and a bowed section when the occlusive element has been expanded to the expanded configuration and positioned adjacent the renal artery ostia of the subject to occlude the renal artery ostia, the bowed section bowing toward the renal artery ostia, and wherein the at least one longitudinal position indication feature is configured to remain in a straightened configuration when the occlusive element has been expanded to the expanded configuration within a blood vessel but has not been positioned adjacent any blood vessel ostia.

### Claim 12 (depends on 1)

The device of claim 1, wherein the at least one longitudinal position indication feature is disposed on the occlusive element along a longitudinal axis of the occlusive element.

### Claim 13 (depends on 1)

The device of claim 1, further comprising a rotational orientation element disposed on the distal portion of the catheter shaft, the rotational orientation element aligned with the occlusive element and configured to indicate the rotational orientation of the occlusive element when positioned adjacent renal artery ostia of the subject while remaining outside the body of the subject.

### Claim 14 (depends on 13)

The device of claim 13, wherein the orientation element comprises one or more of a visible marking, a protrusion, a wing, or a flag.

### Claim 15 (depends on 1)

The device of claim 1, wherein the occlusive element comprises one or more of a mesh braid, an expandable member, or an inflatable balloon.

### Claim 16 (depends on 1)

A system for preventing acute kidney injury from contrast agent introduced into vasculature of a subject, the system comprising:
the device of claim 1; and
a time-delayed release mechanism in communication with the occlusive element of the device, wherein the time-delayed release mechanism is configured to automatically collapse the occlusive element after a pre-determined amount of time following expansion of the occlusive element.

### Claim 17 (depends on 16)

The system of claim 16, wherein the time-delayed release mechanism comprises an energy accumulation and storage component.

### Claim 18 (depends on 17)

The system of claim 17, wherein the energy accumulation and storage component comprises a spring.

### Claim 19 (depends on 18)

The system of claim 18, wherein the energy accumulation and storage component comprises a syringe comprising a plunger, and wherein the spring is coupled to the plunger.
