Apparatus and method for managing incontinence

• US 7,553,273 B2
• Filed: 05/01/2007
• Issued: 06/30/2009
• Est. Priority Date: 05/01/2006
• Status: Active Grant

• Current Assignee: Renew Medical Inc.
• Original Assignee: DuoDyn Technology, LLC
• Inventors: Ferguson, Joe W., Gil, Carlos E.
• Primary Examiner(s): Marmor, II; Charles A
• Assistant Examiner(s): Hopkins; Christine D
• Application Number:
  US11/742,675
• Publication Number:
  US 20070282161A1
• Time in Patent Office: 791 Days
• Field of Search: 600 29- 32, 604/332, 604/334, 128/897
• US Class Current: 600/29
• 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

Abstract

An incontinence management device comprises a head having a first state and a second state. In the first state, the head is sized for insertion within a predetermined body orifice or cavity. In the second state, the head is sized to substantially seal the predetermined body orifice or cavity. In an aspect of use in an anal cavity, the device is configured so that the head forms a seal above the dentate line within the anal cavity. Further, in some aspects, the head substantially comprises a resorbable material. Additionally, in other aspects, the device further comprises a base, which limits insertion of the device within the body orifice, and an activator mechanism in communication with the head and movable relative to the base between a first position and a second position. The movement of the activator mechanism between the first position and the second position correspondingly causes the head to change between the first state and the second state or vice versa.

Claims

1. An incontinence management device, comprising:

a base sized to limit insertion of the incontinence management device into an anal cavity having a dentate line;

a head having a first state and a second state, wherein in the first state the head is sized for insertion within the anal cavity, and wherein in the second state the head is sized to substantially seal the anal cavity above the dentate line;

a neck connected to and extending between the base and the head, wherein the neck comprises a predetermined length to position the head beyond the dentate line when the incontinence management device is located at a deployed position within the anal cavity;

an external surface defining the head, the neck and the base;

an internal wall defining an internal cavity extending through the head the neck and the base to an opening in the base, wherein the internal cavity separates a distal side and a proximal side of the head relative to the opening wherein the head further comprises a permeable section on the distal side wherein the permeable section allows passage of gases and resists passage of liquids and solids;

a scaffolding structure positioned in the internal cavity within at least the head, wherein the scaffolding structure is positioned to separate adjacent portions of the internal wall within the head in the second state, wherein the scaffolding structure is gas permeable, wherein the scaffolding structure comprises a pathway through the head to the internal cavity in the neck and the opening in the base for the gases received through the permeable section of the head; and

a deployment device having an internal deployment cavity extending between an insertion end and an open end, wherein the head, the neck and the base are positionable within the deployment device when the head is in the first state.

2. The device of claim 1, wherein the predetermined length is sized to position the head beyond the dentate line when the base contacts an opening to the anal cavity.

3. The device of claim 1, wherein the predetermined length ranges from about 2 centimeters (cm) to about 5 cm.

4. The device of claim 1, wherein the predetermined length ranges from about 2.5 centimeters (cm) to about 3 cm.

5. The device of claim 1, wherein the head has a diameter ranging from about 1.5 cm to about 5 cm.

6. The device of claim 1, wherein the head has a diameter ranging from about 2.5 cm to about 4.5 cm.

7. The device of claim 1, further comprising a therapeutic agent carried by at least one of the head, the neck and the base.

8. The device of claim 7, further comprising a carrier attached to at least one of the head, the neck and the base, wherein the therapeutic agent is contained within the carrier.

9. The device of claim 1, further comprising:

an activator movably connected to the internal cavity and, wherein the activator is movable between a first position and a second position, wherein the first position maintains the head in the first state, and wherein the second position allows the head to change to the second state.

10. The device of claim 9, wherein the activator comprises a valve.

11. The device of claim 9, wherein the activator comprises a predetermined activator length such that the activator extends from the head to outside of the base when the head is in the first state.

12. The device of claim 1, wherein the head comprises an external surface opposite the neck, wherein the external surface comprises a convex shape.

13. The device of claim 12, wherein the head comprises an internal surface connected to the neck, wherein the internal surface comprises a concave shape.

14. The device of claim 1, wherein the head further comprises a length parallel to a first axis and a width parallel to a second axis different from the first axis, wherein the head is movable between a first shape having a first width operable to permit insertion into the anal cavity and a second shape having a second width operable to seal the anal cavity.

15. The device of claim 1, wherein the deployment device further comprises an activator movable between a pre-deployment position and a deployed position within the internal deployment cavity, wherein the activator comprises an activator length extending between a first end and a second end, wherein the first end is operable to contact the base to urge incontinence management device out of the deployment device through the insertion end during movement of the activator from the pre-deployment position to the deployed position.

16. The device of claim 1, further comprising a therapeutic material.

17. The device of claim 1, wherein the scaffolding structure comprises an elastically deformable material operable to bias the head into the second state.

18. The device of claim 1, wherein the permeable section comprises micropores having a sufficiently small size to resist flowing through of a liquid fluid.

19. The device of claim 1, wherein the head substantially comprises a resorbable material.

20. A method of managing incontinence, comprising:

obtaining a device comprising;

a base sized to limit insertion of the incontinence management device into the anal cavity;

a head having a first state and a second state, wherein in the first state the head is sized for insertion within the anal cavity, and wherein in the second state the head is sized to substantially seal the anal cavity; and

a neck connected to and extending between the base and the head, wherein the neck comprises a predetermined length to position the head beyond the dentate line when the incontinence management device is located at an operating position within the anal cavity;

inserting the device, with the head in the first state, through an anal canal and into an anal cavity such that the head precedes the neck and the base;

positioning the device within the anal cavity so that the head is inserted beyond the dentate line within the anal cavity, and so that the head is operable to change to the second state and form a seal with the anal cavity at a location within the anal cavity beyond the dentate line; and

removing the device from the anal cavity using a retrieval mechanism having an anchor end connected to the device and a gripping end extending from the device and extending outside of the anal cavity.

21. The method of claim 20, wherein inserting further comprises containing the device within a deployment mechanism having an activator mechanism, inserting the deployment mechanism within the anal cavity, and wherein positioning the device further comprises moving the activator mechanism to deploy the device.

22. The method of claim 20, further comprising allowing the device to degrade within the anal cavity according to a predetermined biodegradation characteristic.

23. The method of claim 20, further comprising releasing a therapeutic agent from the device.

24. The method of claim 20, further comprising allowing gas to pass through the device.

25. The method of claim 20, wherein obtaining further comprises obtaining a device comprising:

an external surface defining the head, the neck and the base;

an internal wall defining an internal cavity extending through the head, the neck and the base to an opening in the base, wherein the internal cavity separates a distal side and a proximal side of the head relative to the opening;

wherein the head further comprises a permeable section on the distal side, wherein the permeable section allows passage of gases and resists passage of liquids and solids; and

a scaffolding structure positioned in the internal cavity within at least the head, wherein the scaffolding structure is positioned to separate adjacent portions of the internal wall within the head in the second state, wherein the scaffolding structure is gas permeable, wherein the scaffolding structure comprises a pathway through the head to the internal cavity in the neck and the opening in the base for the gases received through the permeable section of the head.

26. The method of claim 25, wherein obtaining further comprises obtaining a device wherein the scaffolding structure comprises an elastically deformable material operable to bias the head into the second state.

27. An incontinence management device, comprising:

a head having a first state and a second state, wherein in the first state the head is sized for insertion within a predetermined body orifice operable to eject digestive by-products, and wherein in the second state the head is sized to substantially seal the predetermined body orifice;

a layer on the head, the layer comprising a therapeutic material;

a base operable to limit insertion of the device into the predetermined body orifice;

a neck connected to and extending between the head and the base;

an external surface defining the head, the neck and the base;

an internal wall defining an internal cavity extending through the head, the neck and the base to an opening in the base, wherein the internal cavity separates a distal side and a proximal side of the head relative to the opening;

wherein the head further comprises a permeable section on the distal side, wherein the permeable section allows passage of gases and resists passage of liquids and solids; and

a scaffolding structure positioned in the internal cavity within at least the head, wherein the scaffolding structure is positioned to separate adjacent portions of the internal wall within the head in the second state, wherein the scaffolding structure is gas permeable, wherein the scaffolding structure comprises a pathway through the head to the internal cavity in the neck and the opening in the base for the gases received through the permeable section of the head.

28. The device of claim 27, wherein the head substantially comprises a resorbable material.

29. An incontinence management device, comprising:

a base sized to limit insertion of the incontinence management device into an anal cavity having a dentate line;

a head having a first state and a second state, wherein in the first state the head is sized for insertion within the anal cavity, and wherein in the second state the head is sized to substantially seal the anal cavity above the dentate line;

a neck connected to and extending between the base and the head, wherein the neck comprises a predetermined length to position the head beyond the dentate line when the incontinence management device is located at a deployed position within the anal cavity;

an external surface defining the head, the neck and the base;

an internal wall defining an internal cavity extending through the head the neck and the base to an opening in the base, wherein the internal cavity separates a distal side and a proximal side of the head relative to the opening wherein the head further comprises a permeable section on the distal side wherein the permeable section allows passage of gases and resists passage of liquids and solids;

a scaffolding structure positioned in the internal cavity within at least the head, wherein the scaffolding structure is positioned to separate adjacent portions of the internal wall within the head in the second state, wherein the scaffolding structure is gas permeable, wherein the scaffolding structure comprises a pathway through the head to the internal cavity in the neck and the opening in the base for the gases received through the permeable section of the head; and

an activator movably connected to the internal cavity and, wherein the activator is movable between a first position and a second position, wherein the first position maintains the head in the first state, and wherein the second position allows the head to change to the second state, wherein the activator comprises a valve.

30. The device of claim 29, further comprising a therapeutic material.