# US 12,005,197 B1 · Urological device that provides guided placement for an indwelling catheter

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- Number: US 12,005,197 B1
- Document ID: US12005197B1
- Status: Granted
- Kind: B1
- Application number: 18/586,994
- Filed: 2024-02-26
- Granted: 2024-06-11
- Earliest claimed: 2024-02-26
- Assignees: Ouron Medical Inc.; Delmarva Sharpening Service, Inc.
- Applicants: Delmarva Sharpening Service, Inc.; Ouron Medical Inc.
- Inventors: Jeffrey Phillips; Joy Maulik
- Web page: https://patentgrep.com/patent/US12005197B1

## CPC

- A61M 25/0017: {specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections}
- A61M 25/09041: {Mechanisms for insertion of guide wires}
- A61M 25/01: Introducing, guiding, advancing, emplacing or holding catheters (A61M25/10 takes precedence)
- A61M 25/09: Guide wires
- A61M 29/00: Dilators with or without means for introducing media, e.g. remedies
- A61M 39/10: Tube connectors or tube couplings
- A61M 2025/0047: {the inner layer having a higher lubricity}
- 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)}

## Abstract

A urological device, that provides for the guided placement of the distal end of an indwelling catheter into a patient's bladder, includes: (a) a cylinder whose proximal end has a larger diameter than its distal end, (b) a confirmation lumen in the cylinder that is configured to allow for drainage of urine from a patient's bladder to confirm the necessary placement of the device's distal end in a patient's bladder, (c) a guide wire lumen in the cylinder that extends between its ends, (d) a guide wire, and (e) wherein the guide wire lumen is configured to first allow for the passage of the guide wire's distal end through the guide wire lumen and into the patient's bladder and then the withdrawal of the cylinder from the patient's urethra while leaving behind the guide wire's distal end in the patient's urethra for use in the insertion of an indwelling catheter.

## Claims

### Claim 1

A urological device that provides for the guided placement of the distal end of an indwelling catheter into a patient's bladder, said urological device comprising:
a cylinder having a proximal and a distal end, an outer surface, and an axial centerline that extends between said ends,
a connector attached to said cylinder distal end,
a guide wire lumen having a guide wire lumen diameter in said cylinder and that has an inner surface, a distal opening which has a d-o-axial centerline protruding therefrom and with said distal opening being located proximate said cylinder distal end, and a proximal opening which is located proximate said cylinder proximal end,
a guide wire having a guide wire diameter and a gw-distal end and a gw-proximal end,
a confirmation lumen in said cylinder that has a confirmation opening, which is located proximate said cylinder distal end, and a confirmation port, which is located proximate said cylinder proximal end, and wherein said confirmation lumen is configured to drain urine from the bladder of said patient, and
wherein said guide wire lumen is configured to first allow for the passage of said gw-distal end through said guide wire lumen and into said patient bladder and then the withdrawal of said cylinder from the urethra of said patient while leaving behind said gw-distal end in said urethra of said patient for use in the insertion of said indwelling catheter.

### Claim 2 (depends on 1)

The urological device as recited in claim 1, wherein:
the ratio of said guide wire lumen diameter to that of said guide wire diameter is in the range of 1.03-1.5.

### Claim 3 (depends on 1)

The urological device as recited in claim 1, wherein:
the ratio of said guide wire lumen diameter to that of said guide wire diameter is in the range of 1.05-1.1.

### Claim 4 (depends on 1)

The urological device as recited in claim 1, wherein:
the angle, β, between said d-o-axial centerline said cylinder axial centerline is less than 30 degrees.

### Claim 5 (depends on 2)

The urological device as recited in claim 2, wherein:
the angle, β, between said d-o-axial centerline said cylinder axial centerline is less than 30 degrees.

### Claim 6 (depends on 3)

The urological device as recited in claim 3, wherein:
the angle, β, between said d-o-axial centerline said cylinder axial centerline is less than 30 degrees.

### Claim 7 (depends on 1)

The urological device as recited in claim 1, wherein:
said guide wire lumen having a material of construction that is chosen so that said guide wire lumen inner surface is hydrophilic and has a coefficient of friction <0.15.

### Claim 8 (depends on 2)

The urological device as recited in claim 2, wherein:
said guide wire lumen having a material of construction that is chosen so that said guide wire lumen inner surface is hydrophilic and has a coefficient of friction <0.15.

### Claim 9 (depends on 3)

The urological device as recited in claim 3, wherein:
said guide wire lumen having a material of construction that is chosen so that said guide wire lumen inner surface is hydrophilic and has a coefficient of friction <0.15.

### Claim 10 (depends on 4)

The urological device as recited in claim 4, wherein:
said guide wire lumen having a material of construction that is chosen so that said guide wire lumen inner surface is hydrophilic and has a coefficient of friction <0.15.

### Claim 11 (depends on 5)

The urological device as recited in claim 5, wherein:
said guide wire lumen having a material of construction that is chosen so that said guide wire lumen inner surface is hydrophilic and has a coefficient of friction <0.15.

### Claim 12 (depends on 6)

The urological device as recited in claim 6, wherein:
said guide wire lumen having a material of construction that is chosen so that said guide wire lumen inner surface is hydrophilic and has a coefficient of friction <0.15.

### Claim 13 (depends on 1)

The urological device as recited in claim 1, wherein:
said connector is configured to attach to a connector of a filiform that is configured for aiding in a urethral catheterization.

### Claim 14 (depends on 3)

The urological device as recited in claim 3, wherein:
said connector is configured to attach to a connector of a filiform that is configured for aiding in a urethral catheterization.

### Claim 15 (depends on 12)

The urological device as recited in claim 12, wherein:
said connector is configured to attach to a connector of a filiform that is configured for aiding in a urethral catheterization.

### Claim 16

A method that provides for the guided placement of the distal end of an indwelling catheter into a patient's bladder, said method comprising the steps of:
providing a cylinder having a proximal and a distal end, an outer surface, and an axial centerline that extends between said ends,
providing a connector attached to said cylinder distal end,
providing a guide wire lumen, having a guide wire lumen diameter, in said cylinder and that has an inner surface, a distal opening which has a d-o-axial centerline protruding therefrom and with said distal opening being located proximate said cylinder distal end, and a proximal opening which is located proximate said cylinder proximal end,
providing a guide wire having a guide wire diameter and a gw-distal end and a gw-proximal end,
providing a confirmation lumen in said cylinder that has a confirmation opening, which is located proximate said cylinder distal end, and a confirmation port, which is located proximate said cylinder proximal end, and wherein said confirmation lumen is configured to drain urine from the bladder of said patient, and
configuring said guide wire lumen to first allow for the passage of said gw-distal end through said guide wire lumen and into said patient bladder and then the withdrawal of said cylinder from the urethra of said patient while leaving behind said gw-distal end in said urethra of said patient for use in the insertion of said indwelling catheter.

### Claim 17 (depends on 16)

The method as recited in claim 16, wherein:
the ratio of said guide wire lumen diameter to that of said guide wire diameter is in the range of 1.05-1.1.

### Claim 18 (depends on 17)

The method as recited in claim 17, wherein:
the angle, β, between said d-o-axial centerline said cylinder axial centerline is less than 30 degrees.

### Claim 19 (depends on 18)

The method as recited in claim 18, wherein:
said guide wire lumen having a material of construction that is chosen so that said guide wire lumen inner surface is hydrophilic and has a coefficient of friction <0.15.

### Claim 20 (depends on 19)

The method as recited in claim 19, wherein:
said connector is configured to attach to a connector of a filiform that is configured for aiding in a urethral catheterization.
