# US 11,433,217 B2 · Systems and methods for inducing negative pressure in a portion of a urinary tract of a patient

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- Number: US 11,433,217 B2
- Document ID: US11433217B2
- Status: Granted
- Kind: B2
- Application number: 16/542,680
- Filed: 2019-08-16
- Published: 2019-12-05
- Granted: 2022-09-06
- Earliest claimed: 2015-07-20
- Assignees: Roivios Limited
- Applicants: Roivios Limited
- Inventors: John R. Erbey, II; Jacob L. Upperco; David E. Orr; Michael Alan Fisher; Patrick William Strane; Lance Michael Black
- Web page: https://patentgrep.com/patent/US11433217B2

## CPC

- A61M 25/0017: {specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections}
- A61F 2/04: Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts (A61F2/18, A61F2/20 take precedence; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95)
- A61M 1/74: {Suction control (underwater drainage A61M1/61)}
- A61M 1/80: {Suction pumps (A61M1/64, A61M1/71, A61M60/00 take precedence)}
- A61M 25/007: {Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked}
- A61M 25/04: in the body, e.g. expansible {(A61M25/10, A61M16/0488 take precedence)}
- A61M 25/10: Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00})
- A61M 27/008: {pre-shaped, for use in the urethral or ureteral tract}
- A61F 2002/048: {Ureters}
- A61F 2220/0008: Fixation appliances for connecting prostheses to the body
- A61F 2230/0091: helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
- A61M 1/84: {Drainage tubes; Aspiration tips (for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32)}
- A61M 2205/3303: Using a biosensor
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2210/1085: Bladder
- A61M 2210/1089: Urethra
- 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)}
- 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)

## Abstract

Ureteral or bladder catheters are provided, including (a) a proximal portion; and (b) a distal portion, the distal portion including a retention portion that includes one or more protected drainage holes, ports or perforations and is configured to establish an outer periphery or protective surface area that inhibits mucosal tissue from occluding the one or more protected drainage holes, ports or perforations upon application of negative pressure through the catheter. Systems, kits and methods for inducing negative pressure to increase renal function also are provided.

## Claims

### Claim 1

A system for inducing negative pressure in a portion of a urinary tract, the system comprising:
(a) at least one ureteral catheter, the at least one ureteral catheter comprising a distal portion configured for insertion within the kidney, renal pelvis, and/or ureter and a proximal portion; and
(b) a bladder catheter comprising a distal portion configured for insertion within the bladder and a proximal portion configured to transmit negative pressure into the bladder and/or the ureteral catheter, which in turn causes fluid from the kidney to be drawn into and through the ureteral catheter to the bladder, then from the bladder through the bladder catheter, and then outside of the body.

### Claim 2 (depends on 1)

The system according to claim 1, wherein the distal portion of the ureteral catheter comprises a retention portion that comprises one or more protected drainage holes, ports or perforations and is configured to establish an outer periphery or protective surface area that inhibits mucosal tissue from occluding the one or more protected drainage holes, ports or perforations upon the application of negative pressure.

### Claim 3 (depends on 2)

The system according to claim 2, wherein the one or more protected drainage holes, ports or perforations are disposed on a protected surface area or inner surface area of the retention portion of the ureteral catheter, and wherein, upon application of negative pressure, the mucosal tissue conforms or collapses onto the outer periphery or protective surface area of the retention portion of the ureteral catheter and is thereby prevented or inhibited from occluding the one or more of the protected drainage holes, ports or perforations.

### Claim 4 (depends on 1)

The system according to claim 1, wherein the proximal portion of the ureteral catheter is in fluid communication with the distal portion of the bladder catheter.

### Claim 5 (depends on 1)

The system according to claim 1, wherein the distal portion of the bladder catheter comprises a retention portion that comprises one or more protected drainage holes, ports or perforations and is configured to establish an outer periphery or protective surface area that inhibits mucosal tissue from occluding the one or more protected drainage holes, ports or perforations upon the application of negative pressure.

### Claim 6 (depends on 5)

The system according to claim 5, wherein the one or more protected drainage holes, ports or perforations are disposed on a protected surface area or inner surface area of the retention portion of the bladder catheter, and wherein, upon application of negative pressure, the mucosal tissue conforms or collapses onto the outer periphery or protective surface area of the retention portion of the bladder catheter and is thereby prevented or inhibited from occluding the one or more of the protected drainage holes, ports or perforations.

### Claim 7 (depends on 1)

The system according to claim 1, wherein the system further comprises a negative pressure source for application of negative pressure through both the bladder catheter and the ureteral catheter(s), which in turn causes fluid from the kidney to be drawn into and through the ureteral catheter(s), then through the bladder catheter, and then outside of the body.

### Claim 8 (depends on 7)

The system according to claim 7, wherein the negative pressure source comprises a vacuum source external to the body for application and regulation of negative pressure through both the bladder catheter and the ureteral catheter, which in turn causes fluid from the kidney to be drawn into and through the ureteral catheter, then through the bladder catheter, and then outside of the body.

### Claim 9 (depends on 7)

The system according to claim 7, wherein the negative pressure received from the negative pressure source is controlled manually, automatically, or combinations thereof.

### Claim 10 (depends on 7)

The system according to claim 7, wherein a controller is used to regulate negative pressure from the negative pressure source.

### Claim 11 (depends on 10)

The system according to claim 10, wherein the controller provides an accuracy of about 10 mmHg or less.

### Claim 12 (depends on 7)

The system according to claim 7, wherein the negative pressure is provided within a range of about 2 mm Hg to about 150 mm Hg.

### Claim 13 (depends on 1)

The system according to claim 1, further comprising one or more physiological sensors configured to detect at least one physical parameter.

### Claim 14 (depends on 13)

The system according to claim 13, wherein the at least one physical parameter comprises one or more of volume of urine collected, urine composition, urine protein concentration, blood composition or blood flow.

### Claim 15 (depends on 14)

The system according to claim 14, wherein the at least one physical parameter of blood composition comprises one or more of hematocrit ratio, analyte concentration, protein concentration, or creatinine concentration.

### Claim 16 (depends on 14)

The system according to claim 14, wherein the at least one physical parameter of blood flow comprises one or more of blood pressure or blood flow velocity.

### Claim 17 (depends on 13)

The system according to claim 13, wherein the one or more physiological sensors comprise one or more of pulse oximetry sensor(s), blood pressure sensor(s), heart rate sensor(s), respiration sensor(s), capnography sensor(s), glucose sensor(s), blood velocity sensor(s), hemoglobin sensor(s), hematocrit sensor(s), protein sensor(s), creatinine sensor(s), analyte sensor(s), capacitance sensor(s), optical spectroscopy sensor(s) or combinations thereof.

### Claim 18 (depends on 1)

The system of claim 1, wherein the distal portion of the ureteral catheter is configured to be positioned in a kidney, renal pelvis, and/or ureter of a patient.

### Claim 19 (depends on 18)

The system of claim 18, wherein the patient is an animal.

### Claim 20 (depends on 18)

The system of claim 18, wherein the patient is a human.

### Claim 21

A kit comprising:
(a) at least one ureteral catheter, the at least one ureteral catheter comprising a distal portion configured for insertion within the kidney, renal pelvis and/or ureter and a proximal portion; and
(b) at least one disposable bladder catheter comprising a distal portion configured for insertion within the bladder and a proximal portion configured to transmitxxx negative pressure into the bladder and/or the ureteral catheter, which in turn causes fluid from the kidney to be drawn into and through the ureteral catheter to the bladder, then from the bladder through a drainage lumen of the bladder catheter, and then outside of the body;
instructions for at least one of the following: inserting/deploying the ureteral catheter(s), inserting/deploying the bladder catheter(s) or instructions for connecting a proximal end of the bladder catheter to a pump and for operating the pump to draw urine through the drainage lumen of the bladder catheter.
