System and method for assessing urinary function

• US 7,056,288 B2
• Filed: 06/27/2002
• Issued: 06/06/2006
• Est. Priority Date: 06/29/2001
• Status: Active Grant

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Tracey, Michael R., Karl, Frederick T.
• Primary Examiner(s): WEHNER, CARY ELLEN
• Application Number:
  US10/183,075
• Publication Number:
  US 20030023144A1
• Time in Patent Office: 1,440 Days
• Field of Search: 600/221, 600/587, 600/184, 600/187, 600/190, 600/191, 600/197, 600/199, 600/220, 600/222, 600/223, 600/224, 600/135, 600/29
• US Class Current: 600/221
• 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

A vaginal speculum assembly is provided including an upper arm and a lower arm movably coupled to one another by a coupling member positioned at a posterior end. Each of the upper and lower arms are dimensioned for at least partial insertion into a patient'"'"'s vagina, and when so inserted, are dimensioned to exert pressure on at least upper and lower portions of an inner surface of the patient'"'"'s vaginal wall. The coupling member permits movement of the upper and lower arms relative to one another to adjust their positioning relative to the vaginal wall. The assembly further includes a locking device coupled to at least one of the upper and lower arms which, when activated, substantially prevents movement of the upper and lower arms relative to one another. A connector member extends outwardly from a posterior end of the upper arm. The connector member is configured to engage a predetermined portion of an insert device assembly including an insert member to be inserted into the patient'"'"'s urethral canal, to thereby maintain the insert device assembly in position relative to the vaginal speculum assembly.

Claims

1. A vaginal speculum assembly comprising:

an upper arm and a lower arm movably coupled to one another by a coupling member positioned at a posterior end, each of the upper and lower arms being dimensioned for at least partial insertion into a patient'"'"'s vagina, and when so inserted, being dimensioned to exert pressure on at least upper and lower portions of an inner surface of the patient'"'"'s vaginal wall, the coupling member permitting movement of the upper and lower arms relative to one another to adjust their positioning relative to the vaginal wall;

a locking device coupled to at least one of the upper and lower arms that, when activated, substantially prevents movement of the upper and lower arms relative to one another; and

a connector member extending outwardly from a posterior end of the upper arm, the connector member having an engaging portion for engaging an insert member to be inserted into the patient'"'"'s urethra,

wherein, when the upper and lower arms of the speculum assembly are inserted into a patient'"'"'s vagina, the engagment portion is aligned with the patient'"'"'s urethra to thereby maintain said insert member, when engaged therewith, within the patient'"'"'s urethra.

2. The vaginal speculum assembly according to claim 1, wherein at least a portion of the connector member is comprised of a flexible material.

3. The vaginal speculum assembly according to claim 2, wherein the flexible portion can be manually manipulated to engage and grasp the insert device assembly.

4. The vaginal speculum assembly according to claim 1, wherein the coupling member is a hinge member, and said relative movement is pivotal movement about said hinge member.

5. The vaginal speculum assembly according to claim 1, wherein the coupling member permits movement of at least a portion of the upper and lower arms relative to one another in a substantially radial direction.

6. The vaginal speculum assembly according to claim 1, wherein the inset member is a meatus plug member.

7. The vaginal speculum assembly according to claim 1, wherein the insert member is a catheter.

8. A method for assessing urinary function comprising the steps of:

positioning a vaginal speculum assembly relative to a patient'"'"'s vagina so that upper and lower arms of the vaginal speculum assembly support at least upper and lower portions of an inner wall of the patient'"'"'s vagina;

locking the upper and lower arms in position relative to one another;

inserting an insert member of an insert device assembly at least partially into the patient'"'"'s urethral canal;

coupling the insert device assembly to the vaginal speculum assembly so that the insert member remains positioned within the patient'"'"'s urethral canal; and

performing a urodynamic assessment utilizing the insert device assembly.

9. The method according to claim 8, wherein the urodynamic assessment is a stress urinary incontinence test.

10. The method according to claim 8, wherein the urodynamic assessment is a cystometrogram test.

11. The method according to claim 8, wherein the insert member is a meatus plug device.

12. The method according to claim 8, wherein the insert member is a catheter.

13. The method according to claim 8, wherein the step of performing a urodynamic assessment further comprises the steps of infusing fluid into the patient'"'"'s urinary tract, and measuring pressure within the patient'"'"'s urinary tract as fluid is infused therein.

14. The method according to claim 8, wherein the coupling step further comprises the step of coupling a connector member that extends outwardly from a posterior end of the upper arm to the insert device assembly.

15. The method according to claim 14, wherein in the positioning step, the upper and lower arms of the vaginal speculum assembly reduce the patient'"'"'s vaginal prolapse.

16. A vaginal speculum assembly comprising:

an upper arm and a lower arm dimensioned for at least partial insertion into a patient'"'"'s vagina and movably coupled to one another at a posterior end, the upper and lower arms being movably relative to one another between a first collapsed position and a second open position, wherein when inserted into the patient'"'"'s vagina and in the open position, the upper and lower arms exert pressure on upper and lower portions of an inner surface of the patient'"'"'s vaginal wall;

a locking device coupled to at least one of the upper and lower arms that, when activated, substantially prevents movement of the upper and lower arms relative to one another;

a connector member extending outwardly from a posterior end of the upper arm, and having an engaging portion; and

an insert member configured for at least partial insertion into the patient'"'"'s urethral canal,

wherein, when the upper and lower arms are at least partially inserted into the patient'"'"'s vagina and the insert member is at least partially inserted into the patient'"'"'s urethral canal, the engaging portion of the connector member is aligned with the patient'"'"'s urethral canal and configured to engage the insert member so as to maintain the position of the insert member within the urethral canal.

17. The vaginal speculum assembly according to claim 16, wherein the insert member is a meatus plug device.

18. The vaginal speculum assembly according to claim 16, wherein the insert member is a catheter.

19. The vaginal speculum assembly according to claim 16, wherein at least the portion of the connector member configured to engage the insert device assembly is comprised of a flexible material.

20. The vaginal speculum assembly according to claim 16, wherein the upper and lower arms are coupled together by a coupling member, and the coupling member is a hinge member.