Fecal incontinence management device

• US 6,843,766 B1
• Filed: 03/28/2003
• Issued: 01/18/2005
• Est. Priority Date: 12/21/2002
• Status: Expired due to Fees

• Current Assignee: Dignity, Inc.
• Original Assignee: X-L Synergy
• Inventors: Rubio, Edward, Nemir, David C.
• Primary Examiner(s): Gilbert, Samuel G.
• Assistant Examiner(s): Veniaminov, Nikita R.
• Application Number:
  US10/401,479
• Time in Patent Office: 662 Days
• Field of Search: 600/29, 600/587, 600/591, 600/547, 600/373, 600/506, 600/561, 600/488, 600/593, 600/560, 600/55.1, 600/325, 600/546, 482/8, 482/112, 482/113, 606/192, 606/591, 733/790.1, 607/39, 607/138, 607/116, 250/341.8, 250/341.2, 604/93.01, 604/110, 604/111, 604/544
• US Class Current: 600/31
• CPC Class Codes: A61F 2/0013 inflatable

Abstract

An apparatus, and corresponding method, for management of fecal incontinence comprising a catheter having at least two electrodes and an inflatable balloon, a non-conductive sleeve surrounding the electrodes, and an alarm box, wherein the catheter is insertable into a rectal vault and is inflatable to serve as a block to passage of stool and wherein moisture sensed by the electrodes triggers the alarm box and thereby notifies a user that fecal material has entered the rectal vault.

Claims

1. An apparatus for management of fecal incontinence, said apparatus comprising:

means for blocking passage of stool from a rectal vault by use of an inflatable balloon;

means for detecting an electrically conductive path that occurs between at least two electrodes when they come into contact with fecal matter;

non-conductive sleeve surrounding said electrodes; and

means for alarming a user or caregiver upon detection of said electrically conductive path, thereby alerting the user or caregiver of a need to evacuate the rectal vault; and

wherein a moisture trace across said electrodes completes a voltage divider and causes a comparator to change states.

2. An apparatus for management of fecal incontinence comprising a catheter having at least two electrodes and an inflatable balloon, a non-conductive sleeve surrounding said electrodes, and an alarm box, wherein the catheter is insertable into a rectal vault and is inflatable to serve as a block to passage of stool and wherein moisture sensed by said electrodes triggers said alarm box and thereby notifies a user that fecal material has entered the rectal vault, and wherein a moisture trace across said electrodes completes a voltage divider and causes a comparator to change states.

3. The apparatus of claim 2 wherein an integrated circuit is built into said catheter, said integrated circuit providing a means to monitor an amount of time that the catheter is in use.

4. The apparatus of claim 3 wherein said integrated circuit comprises a memory device.

5. The apparatus of claim 2 wherein said non-conductive sleeve is porous but impedes intrusion of moisture onto said electrodes, thereby allowing sensitivity of said alarming means to be tailored to different stool consistencies and reducing occurrences of false alarms during insertion.

6. The apparatus of claim 5 wherein said sleeve is detachable and designed for one time use.

7. The apparatus of claim 5 wherein said sleeve comprises an external support flange with flexible attachment guides configured so that when said balloon is inflated, said attachment guides deform, causing said external support flange and said balloon to move closer to each other and serving to seat said balloon at an anorectal line.

8. The apparatus of claim 7 wherein said external support flange provides a platform onto which an absorbent pad may be added, thereby ensuring that seepage around the balloon is reduced to reduce soiling of undergarments.

9. The apparatus of claim 2 wherein said balloon deflates over a period of time to enforce a minimum level of attention.

10. A method for management of fecal incontinence, the method comprising the steps of:

blocking passage of stool from a rectal vault by use of an inflatable balloon;

detecting an electrically conductive path that occurs between at least two electrodes when they come into contact with fecal matter;

employing a non-conductive sleeve surrounding the electrodes; and

alarming a user or caregiver upon detection of the electrically conductive path, thereby alerting the user or caregiver of a need to evacuate the rectal vault; and

wherein in the detecting step a moisture trace across the electrodes completes a voltage divider and causes a comparator to change states.

11. The method of claim 10 wherein the blocking, detecting, and employing steps are performed by a catheter.

12. The method of claim 11 additionally comprising the step of monitoring an amount of time that the catheter is in use.

13. The method of claim 12 wherein the monitoring step employs an integrated circuit comprising a memory device.

14. The method of claim 10 wherein in the employing step the non-conductive sleeve is porous but impedes intrusion of moisture onto the electrodes, thereby allowing sensitivity of alarming to be tailored to different stool consistencies and reducing occurrences of false alarms during insertion.

15. The method of claim 14 wherein the sleeve is detachable and designed for one time use.

16. The method of claim 14 wherein the sleeve comprises an external support flange with flexible attachment guides configured so that when the balloon is inflated, the attachment guides deform, causing the external support flange and the balloon to move closer to each other and serving to seat the balloon at an anorectal line.

17. The method of claim 16 wherein the external support flange provides a platform onto which an absorbent pad may be added, thereby ensuring that seepage around the balloon is reduced to reduce soiling of undergarments.

18. The method of claim 10 additionally comprising the step of permitting the balloon to deflate over a period of time to enforce a minimum level of attention.

19. An apparatus for management of fecal incontinence comprising a catheter having at least two electrodes and an inflatable balloon, a non-conductive sleeve surrounding said electrodes, and an alarm box, wherein the catheter is insertable into a rectal vault and is inflatable to serve as a block to passage of stool and wherein moisture sensed by said electrodes triggers said alarm box and thereby notifies a user that fecal material has entered the rectal vault, and wherein an integrated circuit is built into said catheter, said integrated circuit providing a means to monitor an amount of time that the catheter is in use.

20. The apparatus of claim 19 wherein said integrated circuit comprises a memory device.

21. An apparatus for management of fecal incontinence comprising a catheter having at least two electrodes and an inflatable balloon, a non-conductive sleeve surrounding said electrodes, and an alarm box, wherein the catheter is insertable into a rectal vault and is inflatable to serve as a block to passage of stool and wherein moisture sensed by said electrodes triggers said alarm box and thereby notifies a user that fecal material has entered the rectal vault, wherein said non-conductive sleeve is porous but impedes intrusion of moisture onto said electrodes, thereby allowing sensitivity of said alarming means to be tailored to different stool consistencies and reducing occurrences of false alarms during insertion, and wherein said sleeve comprises an external support flange with flexible attachment guides configured so that when said balloon is inflated, said attachment guides deform, causing said external support flange and said balloon to move closer to each other and serving to seat said balloon at an anorectal line.

22. The apparatus of claim 21 wherein said external support flange provides a platform onto which an absorbent pad may be added, thereby ensuring that seepage around the balloon is reduced to reduce soiling of undergarments.

23. A method for management of fecal incontinence, the method comprising the steps of:

blocking passage of stool from a rectal vault by use of an inflatable balloon;

detecting an electrically conductive path that occurs between at least two electrodes when they come into contact with fecal matter;

employing a non-conductive sleeve surrounding the electrodes;

alarming a user or caregiver upon detection of the electrically conductive path, thereby alerting the user or caregiver of a need to evacuate the rectal vault; and

monitoring an amount of time that the catheter is in use.

24. The method of claim 23 wherein the monitoring step employs an integrated circuit comprising a memory device.

25. A method for management of fecal incontinence, the method comprising the steps of:

blocking passage of stool from a rectal vault by use of an inflatable balloon;

detecting an electrically conductive path that occurs between at least two electrodes when they come into contact with fecal matter;

employing a non-conductive sleeve surrounding the electrodes; and

alarming a user or caregiver upon detection of the electrically conductive path, thereby alerting the user or caregiver of a need to evacuate the rectal vault; and

wherein in the employing step the non-conductive sleeve is porous but impedes intrusion of moisture onto the electrodes, thereby allowing sensitivity of alarming to be tailored to different stool consistencies and reducing occurrences of false alarms during insertion; and

wherein the sleeve comprises an external support flange with flexible attachment guides configured so that when the balloon is inflated, the attachment guides deform, causing the external support flange and the balloon to move closer to each other and serving to seat the balloon at an anorectal line.

26. The method of claim 25 wherein the external support flange provides a platform onto which an absorbent pad may be added, thereby ensuring that seepage around the balloon is reduced to reduce soiling of undergarments.