Devices and methods for assessment and treatment of urinary and fecal incontinence

• US 6,110,099 A
• Filed: 07/16/1998
• Issued: 08/29/2000
• Est. Priority Date: 11/13/1995
• Status: Expired due to Term

• Current Assignee: Basin Medical, LLC
• Original Assignee: Theodore V. Benderev
• Inventors: Benderev, Theodore V.
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US09/116,696
• Time in Patent Office: 775 Days
• Field of Search: 600/29-32, 128/DIG. 25, 128/897-98, 128/774, 128/778, 128/775, 33/511, 33/512
• US Class Current: 600/30
• CPC Class Codes: A61F 2/0009 placed in or outside the body opening close to the surface of the body plugging an opening in the wall of a hollow or tubular organ A61B17/0057
• CPC Class Codes: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

Apparatus and methods for treating urinary and fecal incontinence, urinary drainage, and prolapse. In the first preferred embodiment, the invention comprises a device body insertable into an anatomical passageway and includes a stimulus-producing device disposed therein to provide a signal to the user to perform pelvic strengthening exercises or alternatively, an exercise monitoring device for monitoring exercise activity. In an embodiment for facilitating urinary drainage, there is provided an annular base panel coupled to an anchor member, the latter being designed to anchor the device within an anatomical passageway, such as the vagina. A port formed on the annular panel is provided to mate with the urethral meatus so that a continuous conduit is formed between the urethral meatus and the port. The various embodiments disclosed may further be utilized as pessary devices to provide structural support to the pelvis or utilized to construct customized pessary devices.

Claims

1. A device which is adapted to be inserted into a pelvic anatomical passageway of a human being to identify and target pelvic floor muscles and facilitate the performance of pelvic muscle strengthening exercises therefor, said device comprising:

a) a device body sized and configured to be slidably inserted and anchored within said anatomical passageway, said device body being adapted to selectively exert a perceptible stimulus against a predetermined region of said anatomical passageway located adjacent to said device body; and

b) a switching device formed with said device body for selectively and intermittently causing said device body to exert and cease exerting said perceptible stimulus.

2. The device of claim 1, wherein said device body is formed to have distal, intermediate, and proximal portions, said distal portion being sized and configured to be frictionally retained and anchored adjacent the inlet to said passageway and exert said perceptible stimulus thereto.

3. The device of claim 1 wherein:

a) said distal portion of said device body is formed to have a generally arrowhead-shaped configuration;

b) said intermediate portion of said device body is formed to have a generally shaft-shaped configuration; and

c) said proximal portion of said device body is formed to have a handle portion formed thereon to facilitate manual manipulation of said device.

4. The device of claim 1 wherein said device further includes:

d) a timer apparatus disposed within said device body and coupled to said switching device to enable such device to cause the device body to selectively exert said perceptible stimulus at predetermined times.

5. The device of claim 1 wherein said anatomical passageway is the vagina and wherein said device body is sized and configured for intra-vaginal insertion.

6. The device of claim 1 wherein said anatomical passageway is the anus and said device body is sized and configured for intra-anal insertion.

7. The device of claim 1 wherein said perceptible stimulus exerted by said device body is produced by a stimulus-producing device disposed within said device body.

8. The device of claim 7 wherein said stimulus producing device comprises a pressure-exerting device designed to be alternatively transitional between:

a) a rest mode configuration wherein said device causes the device body to exert no more than a baseline amount of pressure against a predetermined region of said anatomical passageway within which the device body is rotated adjacent to said device body; and

b) an exercise mode configuration wherein said device causes the device body to exert more than the baseline amount of pressure against the predetermined region of the anatomical passageway, said pressure exerted in said exercise mode configuration being of sufficient degree to produce a perceptible stimulus.

9. The device of claim 7 wherein said stimulus producing device comprises a vibrator apparatus for causing at least a portion of said device body to vibrate.

10. A device which is adapted to be inserted into a pelvic anatomical passageway of a human being to identify pelvic floor muscles and facilitate the performance of pelvic muscle strengthening exercises, said device comprising:

a) a device body sized and configured to be slidably inserted and frictionally retained within said anatomical passageway, said device body being adapted to selectively exert a perceptible stimulus against a predetermined region of said anatomical passageway located adjacent to said device body; and

b) a switching device coupled to said device body for selectively and intermittently causing said device body to exert and cease exerting said perceptible stimulus.

11. The device of claim 10 wherein said switching device is housed within a remote enclosure and coupled to said device body via an electrical cord to thus enable the switching device to be operated from outside the anatomical passageway within which the device body is retained.

12. The device of claim 10 wherein said device body is designed and adapted to exert first and second perceptible stimuli.

13. The device of claim 12 wherein said first perceptible stimulus is produced by a first stimulus producing device and said second perceptible stimulus is produced by a second stimulus producing device.

14. The device of claim 12 wherein said first stimulus producing device is selected from the group comprising a vibrator, and pressure-exerting device, wherein said pressure-exerting device is designed to be alternately transitional between:

a) a rest mode configuration wherein said device causes the device body to exert no more than a baseline amount of pressure against a predetermined region of said anatomical passageway within which the device body is rotated adjacent to said device body; and

b) an exercise mode configuration wherein said device causes the device body to exert more than the baseline amount of pressure against the predetermined region of the anatomical passageway, said pressure exerted in said exercise mode configuration being of sufficient degree to produce a perceptible stimulus.

15. The device of claim 13 wherein said switching device is provided with dedicated switching members to selectively cause said first and second stimulus producing devices to exert a respective perceptible stimuli produced thereby.

16. The device of claim 14 wherein said switching device is provided with a timer coupled to said dedicated switching members for causing said members to selectively actuate said first and second stimulus producing devices at predetermined times.

17. A device adapted to be inserted into a pelvic anatomical passageway of a patient for facilitating the drainage of urine therefrom, said device comprising:

a) a base panel having a port formed thereon;

b) an anchor member affixed to said base panel for securing said device within said anatomical passageway, said anchor being so securable within the said passageway such that said panel member and port formed thereon are anatomically alignable with and sealable to the urethral meatus of the patient such that when such port is so aligned with such urethral meatus, a continuous conduit is defined through which urine may flow from the bladder and through said port.

18. The device of claim 17 wherein said anchor member comprises a generally mushroom-shaped cap member that is selectively deformable to assume a first insertion configuration whereby such anchor member is received within said anatomical passageway, and a second anchoring configuration whereby said anchor is caused to radially compress about said passageway to thus cause said device to remain seated therewithin.

19. The device of claim of 18 wherein said mushroom-shaped anchor member is caused to radially compress about said passageway when in said second anchoring configuration by radially inverting within said passageway.

20. The device of claim 17 wherein said base panel is rotatably connected to said anchor member such that said panel may be rotated to align said port formed thereon with said urethral meatus.

21. The device of claim 17 wherein said anchor member is designed and configured to be received and secured within the vagina.

22. The device of claim 17 wherein said anchor member is designed and configured to be received and secured within the anus.

23. The device of claim 17 wherein said anchor member comprises a head portion and a neck portion, said anchor member being selectively transitionable between an insertion configuration wherein said head portion assumes a first dimension and a second anchor configuration wherein said head portion assumes a size substantially greater than said first configuration.

24. The device of claim 22 wherein said anchor member is specifically designed and configured to provide structural support to said anatomical passageway when said anchor assumes said anchor configuration.

25. A device which is adapted to be inserted into the opening of the mouth of a human being to identify and target facial muscles and facilitate the performance of facial muscle strengthening exercises therefor, said device comprising:

a) a device body sized and configured to be slidably inserted and anchored within said opening of said patient'"'"'s mouth, said device body being adapted to selectively exert a perceptible stimulus against a predetermined region of said opening of said patient'"'"'s mouth located adjacent to said device body; and

b) a switching device formed within said device body for selectively causing said device body to exert said perceptible stimulus.

26. A device which is adapted to be inserted into a pelvic anatomical passageway of a human being to identify and target pelvic floor muscles and monitor the performance of pelvic muscle strengthening exercises therefor, said device comprising:

a) a device body sized and configured to be slidably inserted and anchored within said anatomical passageway;

b) an exercise monitoring device disposed within said device body for monitoring the frequency and duration said target pelvic floor muscles are exercised and measure the progress made in the strengthening thereof.

27. The device of claim 26 wherein said exercise monitoring device is further designed to produce a biofeedback signal to facilitate a volitional performance of said pelvic muscle strengthening exercises.

28. A device for determining the contours and dimensions of an anatomical passageway comprising:

a) an insert member sized and configured to be slidably inserted within said anatomical passageway, said insert member being selectively expanded such that said insert member substantially conforms to the specific dimensions of said anatomical passageway within which said insert member is received; and

b) a measuring apparatus coupled to said insert member for measuring the size and shape of said insert member when said insert member selectively assumes said size and dimensions of said anatomical passageway.

29. The device of claim 28 wherein said insert member selectively transitions between an insertion configuration wherein said insert member assumes a first size and shape, and a second measuring configuration wherein said insert member assumes said size and shape of said anatomical passageway within which said insert member is received.

30. The device of claim 28 wherein said measuring apparatus further designed to generate measurement and dimension data of said anatomical passageway wherein said measurement and dimension data is utilized to form a custom pessary device for placement within said anatomical passageway.