System and method for assessing urinary function

• US 20030028159A1
• Filed: 06/27/2002
• Published: 02/06/2003
• Est. Priority Date: 06/29/2001
• Status: Active Grant

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Bayer, Hanspeter R., Tracey, Michael R., Karl, Frederick T., Nohilly, Martin
• Granted Patent: US 6,896,650 B2
• Time in Patent Office: Days
• US Class Current: 604/328
• CPC Class Codes: A61B 1/32 Devices for opening or enlarging the visual field, e.g. of a tube of the body dilators A61M29/00
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 5/202 Assessing bladder functions, e.g. incontinence assessment
• CPC Class Codes: A61B 5/204 Determining bladder volume
• CPC Class Codes: A61B 5/205 Determining bladder or urethral pressure
• CPC Class Codes: A61B 5/208 adapted to determine urine quantity, e.g. flow, volume
• CPC Class Codes: A61B 5/7435 Displaying user selection data, e.g. icons in a graphical user interface
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end

Abstract

An insertion device is provided for use in assessing urinary function. The insert device includes an insert member for at least partial insertion into a patient'"'"'s urethral canal having a length such that it is positioned distal of the urethral sphincter, and having an outer surface at least a portion of which is configured to engage the inner wall of the urethra to substantially prevent fluid flow therebetween. The insert member has a channel therethrough through which fluid from a fluid source can be introduced into the urethral canal. Also provided is a device for introducing fluid into a patient'"'"'s urethral canal including a hand-sized casing having a fluid conduit therein between a fluid inlet and a fluid source assembly. The device further includes an activation device movable between a first position wherein it does not obstruct the fluid conduit and a second position wherein it does obstruct the fluid conduit. An insert member is coupled to a distal end of the hand-sized casing and has a channel therethrough between a fluid inlet and a fluid outlet, and is dimensioned for at least partial insertion into the patient'"'"'s urethral canal distal of the urethral sphincter. The insert member channel is in fluid communication with the fluid conduit.

Claims

1. An insertion device, comprising:

an insert portion dimensioned for insertion into a patient'"'"'s urethral canal, the insert portion having a length such that it is positioned distal of the patient'"'"'s urethral sphincter, and having an outer surface at least a portion of which is configured to engage an inner wall of the urethral canal to substantially prevent fluid flow therebetween,

the insertion device having a channel extending therethrough through which fluid from a fluid source may be introduced into the urethral canal distal of the urethral sphincter.

2. The insertion device according to claim 1, further comprising a plurality of apertures spaced apart around a distal portion of the insert portion, the plurality of apertures being in fluid communication with the insertion device channel.

3. The insertion device according to claim 2, wherein a diameter of the distal portion at a location of the plurality of apertures is less than a diameter of the urethral canal inner wall.

4. The insertion device according to claim 1, wherein an outer surface of a distal portion of the insert portion is substantially conical in shape.

5. The insertion device according to claim 1, wherein an outer surface of a distal portion of the insert portion is substantially conical in shape, has a plurality of spaced apart apertures therein, and decreases in diameter towards a distal end, wherein a diameter of the distal portion at the location of the apertures is sufficiently smaller than a diameter of the urethral canal inner wall so that fluid may flow through the apertures to the urethral sphincter.

6. The insertion device according to claim 1, wherein the insert portion further comprises a distal insert portion and a proximal insert portion, the distal portion being substantially conical in shape and decreasing in diameter toward a distal end of the insert portion.

7. The insertion device according to claim 6, wherein the proximal portion is configured to engage the urethral canal inner wall to substantially prevent fluid flow therebetween.

8. A device for introducing fluid into a patient'"'"'s urethral canal, comprising:

a hand-sized casing having a fluid conduit therein between a fluid outlet and a fluid source assembly;

an activation device movable between a first position wherein it does not obstruct the fluid conduit and a second position wherein it does obstruct the fluid conduit to substantially block fluid flow therethrough; and

an insert member coupled to a distal end of the hand-sized casing and having a channel therethrough between an insert member fluid inlet and an insert member fluid outlet located at a distal end thereof, wherein the insert member channel is in fluid communication with the fluid conduit, and wherein the insert member is dimensioned for at least partial insertion into a patient'"'"'s urethral canal distal of the patient'"'"'s urethral sphincter.

9. The device according to claim 8, wherein the insert member further comprises an outer surface at least a portion of which is configured to engage an inner wall of the urethral canal to substantially prevent fluid flow therebetween.

10. The device according to claim 9, wherein the outer surface of a distal portion of the insert member is substantially conical in shape and decreases in diameter toward the distal end.

11. The device according to claim 10, wherein the distal portion of the insert member further comprises a plurality of spaced apart apertures therein, and wherein an outer diameter of the distal portion at the location of the apertures is less than a diameter of the urethral canal inner wall.

12. The device according to claim 8, wherein the fluid source assembly is a fluid reservoir positioned within the hand-sized casing, and coupled to and in fluid communication with the fluid conduit.

13. The device according to claim 8, wherein the fluid source assembly is a fluid reservoir and tubing in fluid communication with the fluid reservoir, and wherein a fluid inlet of the fluid conduit is coupled to and in fluid communication with the tubing.

14. The device according to claim 8, wherein the hand-sized casing has an aperture therein through which the activation device extends, the activator device further comprising a trigger element located outside of said casing, and one or more coupling members coupled to the trigger element and extending through the aperture within the actuator casing, and being pivotably relative to casing to thereby enable the activation device to pivot between the first and second positions.

15. The device according to claim 8, further comprising an air bladder located within the hand-sized casing, wherein the activation device does not compress the air bladder when in the first position, and at least partially depresses the air bladder when in the second position.

16. The device according to claim 8, wherein the device further comprises an air bladder coupled to and in fluid communication with a second fluid conduit that is positioned within the hand-sized casing.

17. A device for introducing fluid into a patient'"'"'s urethral canal, comprising:

a hand-sized housing having a first fluid conduit therethrough between a first fluid inlet at a proximal end and a first fluid outlet at a distal end;

a means for obstructing the first fluid conduit to selectively substantially prevent fluid flow therethrough; and

an insert member coupled to the distal end of the housing, and having a channel therethrough in fluid communication with the first fluid conduit, the insert member being dimensioned for at least partial insertion into the patient'"'"'s urethral canal distal of the urethral sphincter, wherein when so inserted, fluid infused into the insert member channel may pass into the urethral canal distal of the urethral sphincter.

18. The device according to claim 17, wherein the means for obstructing further comprises an activation device pivotably coupled to the hand-sized housing and pivotable between a first position wherein it does not obstruct the first fluid conduit and a second position wherein it obstructs the first fluid conduit to substantially prevent fluid flow therethrough.

19. The device according to claim 17, wherein the insert member further comprises a distal portion having a plurality of spaced apart apertures therein.

20. The device according to claim 19, wherein the distal portion is substantially conical in shape, and has an outer diameter that decreases towards a distal end, and wherein a diameter of the distal portion at the location of the apertures is less than a diameter of an inner wall of the urethral canal.

21. The device according to claim 20, wherein at least a portion of the insert member is configured to engage the urethral canal inner wall to substantially prevent fluid flow therebetween.

22. The device according to claim 17, wherein the insert member further comprises a distal portion having a substantially conical shape and an outer diameter that decreases towards a distal end, and wherein at least a portion of an outer surface of the insert member is configured to engage the urethral canal wall so as to substantially prevent fluid flow therebetween.