# US 11,896,785 B2 · Ureteral and bladder catheters and methods of inducing negative pressure to increase renal perfusion

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- Number: US 11,896,785 B2
- Document ID: US11896785B2
- Status: Granted
- Kind: B2
- Application number: 17/340,858
- Filed: 2021-06-07
- Published: 2021-09-23
- Granted: 2024-02-13
- Earliest claimed: 2015-07-20
- Assignees: Roivios Limited
- Applicants: Roivios Limited
- Inventors: David E. Orr; Jacob L. Upperco; John R. Erbey, II
- Web page: https://patentgrep.com/patent/US11896785B2

## CPC

- A61M 25/04: in the body, e.g. expansible {(A61M25/10, A61M16/0488 take precedence)}
- A61B 5/208: {adapted to determine urine quantity, e.g. flow, volume}
- A61B 5/6853: {with a balloon}
- A61B 5/6857: {with a distal pigtail shape}
- A61M 1/08: Cupping glasses {, i.e. for enhancing blood circulation}
- A61M 1/73: {comprising sensors or indicators for physical values}
- A61M 1/74: {Suction control (underwater drainage A61M1/61)}
- A61M 1/743: {by changing the cross-section of the line, e.g. flow regulating valves (A61M1/7413 takes precedence)}
- A61M 1/75: {Intermittent or pulsating suction (A61M1/63, A61M1/772 take precedence)}
- A61M 1/80: {Suction pumps (A61M1/64, A61M1/71, A61M60/00 take precedence)}
- A61M 1/84: {Drainage tubes; Aspiration tips (for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32)}
- A61M 25/0017: {specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections}
- A61M 25/0023: {by the form of the lumen, e.g. cross-section, variable diameter}
- A61M 25/0026: {Multi-lumen catheters with stationary elements (catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175)}
- A61M 25/0041: {pre-formed, e.g. specially adapted to fit with the anatomy of body channels (urethral catheters A61F2/04)}
- A61M 25/007: {Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked}
- A61M 25/0108: {using radio-opaque or ultrasound markers}
- A61M 25/1025: {Connections between catheter tubes and inflation tubes}
- A61M 27/008: {pre-shaped, for use in the urethral or ureteral tract}
- A61B 5/6858: {with a distal basket, e.g. expandable basket}
- 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 39/12: for joining a flexible tube to a rigid attachment
- A61M 2025/0008: {having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type}
- A61M 2025/0213: {where the catheter is attached by means specifically adapted to a part of the human body}
- A61M 2202/0496: Urine
- A61M 2205/3303: Using a biosensor
- A61M 2205/3317: Electromagnetic, inductive or dielectric measuring means
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3368: Temperature
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2205/583: by visual feedback
- A61M 2210/1082: Kidney
- A61M 2210/1085: Bladder
- A61M 2210/1089: Urethra
- A61M 2230/00: Measuring parameters of the user
- A61M 2230/207: hematocrit
- A61M 2230/50: Temperature
- A61M 2230/65: Impedance, e.g. conductivity, capacity
- 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A ureteral catheter includes a drainage lumen including a proximal portion configured to be positioned in at least a portion of a patient's urethra and/or bladder and a distal portion configured to be positioned in a patient's kidney, renal pelvis, and/or in the ureter adjacent to the renal pelvis, the distal portion including a retention portion for maintaining positioning of the distal portion of the drainage lumen, the retention portion including two or more openings on a sidewall of the retention portion for permitting fluid flow into the drainage lumen, wherein a number of the openings nearer to a distal end of the retention portion is greater than a number of the opening(s) nearer to a proximal end of the retention portion.

## Claims

### Claim 1

A ureteral catheter, comprising:
a drainage lumen comprising a proximal portion configured to be positioned in at least a portion of an urethra and/or bladder and a distal portion configured to be positioned in a kidney, renal pelvis, and/or in the ureter adjacent to the renal pelvis, the distal portion comprising a retention portion for maintaining positioning of the distal portion of the drainage lumen, the retention portion comprising two or more openings on a sidewall of the retention portion for permitting fluid flow into the drainage lumen, wherein a number of the openings nearer to a distal end of the retention portion is greater than a number of the opening(s) nearer to a proximal end of the retention portion.

### Claim 2 (depends on 1)

The ureteral catheter of claim 1, wherein the proximal portion of the drainage lumen is essentially free of or free of openings.

### Claim 3 (depends on 1)

The ureteral catheter of claim 1, wherein the proximal portion of the drainage lumen is configured to extend outside of the body.

### Claim 4 (depends on 1)

The ureteral catheter of claim 1, wherein the retention portion further comprises:
at least one first coil having a first diameter; and
at least one second coil having a second diameter, the first diameter being less than the second diameter, the second coil being closer to the distal end of the drainage lumen than the first coil.

### Claim 5 (depends on 1)

The ureteral catheter of claim 1, wherein the sidewall comprises a radially inwardly facing side and a radially outwardly facing side, and wherein a total area of the openings on the radially inwardly facing side is greater than a total area of the openings on the radially outwardly facing side.

### Claim 6 (depends on 1)

The ureteral catheter of claim 1, wherein the sidewall comprises a radially inwardly facing side and a radially outwardly facing side, and wherein one or more openings are disposed on the radially inwardly facing side, and wherein the radially outwardly facing side is essentially free or free of openings.

### Claim 7 (depends on 4)

The ureteral catheter of claim 4, wherein the retention portion further comprises a third coil, the third coil having a diameter greater than or equal to either the first diameter or the second diameter, the third coil being closer to an end of the distal portion of the drainage lumen than the second coil.

### Claim 8 (depends on 1)

The ureteral catheter of claim 1, wherein a total area of the one or more openings increases for openings closer to a distal end of the retention portion.

### Claim 9 (depends on 1)

The ureteral catheter of claim 1, wherein the drainage lumen comprises an open distal end.

### Claim 10 (depends on 1)

The ureteral catheter of claim 1, wherein an area of a single opening closer to the proximal portion of the drainage lumen is less than an area of a single opening closer to the distal end of the drainage lumen.

### Claim 11 (depends on 1)

The ureteral catheter of claim 1, wherein an area of each single opening nearer to the proximal end of the retention portion is less than an area of a distally adjacent single opening.

### Claim 12 (depends on 1)

The ureteral catheter of claim 1, wherein each of the openings has the same area.

### Claim 13 (depends on 1)

The ureteral catheter of claim 1, wherein each opening is independently selected from one or more of circles, triangles, rectangles, ellipses, ovals, and squares.

### Claim 14 (depends on 1)

The ureteral catheter of claim 1, wherein less than 70%, or less than 55%, by volume of fluid flow is drawn into the drainage lumen through a single opening positioned near the proximal end of the retention portion.

### Claim 15 (depends on 1)

A system for inducing negative pressure in a portion of a urinary tract of a patient, the system comprising:
at least one ureteral catheter of claim 1; and
a pressure source in fluid communication with the drainage lumen of the at least one ureteral catheter, the pressure source being configured for inducing a positive or a negative pressure in a portion of the urinary tract of the patient to draw fluid into the drainage lumen through the openings of the retention portion.

### Claim 16 (depends on 15)

The system of claim 15, wherein the pressure source comprises a pump.

### Claim 17 (depends on 15)

The system of claim 15, wherein the pump is configured to operate at one of three pressure levels, the pressure levels generating a negative pressure of 15 mmHg, 30 mmHg, or 45 mmHg.

### Claim 18 (depends on 15)

The system of claim 15, wherein the pump is configured to alternate between generating negative pressure and generating positive pressure.

### Claim 19 (depends on 15)

The system of claim 15, further comprising:
one or more sensors in fluid communication with the drainage lumen, the one or more sensors being configured to determine information comprising at least one of capacitance, analyte concentration, and temperature of urine within the drainage lumen; and
a controller configured to receive the information from the one or more sensors and adjust an operating parameter of the pressure source based, at least in part, on the information received from the one or more sensors to increase or decrease vacuum pressure in the drainage lumen of the at least one ureteral catheter to adjust flow of urine through the drainage lumen.

### Claim 20 (depends on 15)

The system of claim 15, comprising a first ureteral catheter configured to be placed in a first kidney, renal pelvis, and/or in the ureter adjacent to the renal pelvis and a second ureteral catheter configured to be placed in a second kidney, renal pelvis, and/or in the ureter adjacent to the renal pelvis, wherein the pressure source is configured to apply negative pressure independently to the first ureteral catheter and the second ureteral catheter such that the pressure in each catheter can be the same or different from the other catheter.

### Claim 21 (depends on 1)

The ureteral catheter of claim 1, wherein the catheter is configured to be deployed in a urinary tract of a patient.

### Claim 22 (depends on 1)

The ureteral catheter of claim 1, wherein the patient is an animal.

### Claim 23 (depends on 15)

The system of claim 15, wherein the catheter is configured to be deployed in a urinary tract of a patient.

### Claim 24 (depends on 15)

The system of claim 15, wherein the patient is an animal.

### Claim 25 (depends on 1)

A negative pressure therapy system for increasing urine production, the negative pressure therapy system comprising:
(a) a negative pressure assembly, the negative pressure assembly comprising:
(i) a negative pressure source configured to provide negative pressure to a kidney, and
(ii) a controller configured to regulate the negative pressure provided by the negative pressure source within a pressure range that facilitates increased urine production from the kidney, and
(b) at least one ureteral catheter according to claim 1, wherein each of at least two openings has the same area, and wherein more openings are near a distal end of the catheter than are near a proximal end of the catheter.

### Claim 26 (depends on 25)

The negative pressure therapy system of claim 25, wherein the at least two openings are on a radially inwardly facing side of the retention portion, and wherein a radially outwardly facing side of the retention portion is essentially free of openings.

### Claim 27 (depends on 25)

The negative pressure therapy system of claim 25, wherein the catheter is configured to be deployed in a urinary tract of a patient.

### Claim 28 (depends on 27)

The negative pressure therapy system of claim 27, wherein the patient is an animal.
