Transanal irrigation kit

• US 9,770,548 B2
• Filed: 10/11/2012
• Issued: 09/26/2017
• Est. Priority Date: 11/08/2011
• Status: Active Grant

• Current Assignee: Hollister Incorporated
• Original Assignee: Hollister Incorporated
• Inventors: Gilman, Thomas H.
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): Snyder, Melissa A
• Application Number:
  US14/354,027
• Publication Number:
  US 20140276631A1
• Time in Patent Office: 1,811 Days
• CPC Class Codes: A61M 2210/1064 Large intestine
• CPC Class Codes: A61M 2210/1067 Anus
• CPC Class Codes: A61M 3/0262 manually, e.g. by squeezing a bulb
• CPC Class Codes: A61M 3/0279 Cannula; Nozzles; Tips; their connection means

Abstract

An anal irrigation kit provides an improved approach for emptying a bowel by instilling irrigation liquid and stimulating the rectal wall simultaneously. The anal irrigation kit includes an irrigation liquid reservoir, a hand pump, and a soft flow manifold, which can be folded for insertion into a rectum.

Claims

1. An anal irrigation kit, comprising:

an irrigation liquid reservoir;

a pump in fluid communication with the irrigation liquid reservoir; and

a flow manifold in fluid communication with the pump, the flow manifold including multiple openings, wherein the flow manifold is made of a soft, resilient polymeric material, such that the flow manifold is sufficiently stiff to be pushed through an anal canal and self-deployable once in a rectum, but soft enough to be manually foldable for insertion into the rectum;

the flow manifold further includes a distalmost flared-end portion including a flared wall with an outer surface area configured to sealingly engage the rectum as fluid flows through the flow manifold and a cover portion attached to a distalmost flared edge of the flared wall,

wherein a flow lumen is defined by an enclosed inner surface area of the flared-end portion between the flared wall and the cover portion and a plurality of the multiple openings are arranged about the distalmost flared edge of the flared wall in fluid communication with the flow lumen

wherein the irrigation liquid reservoir has an inlet, an inner wall and an outer wall, the inner wall and the outer wall being sealed together along peripheral edges to define a cavity; and

the pump is a hand pump including a rigid outer wall, a top inlet and a bottom outlet; and

the flow manifold has an entry end proximate the hand pump.

2. The anal irrigation kit of claim 1, wherein the flow manifold is made of a silicone rubber.

3. The anal irrigation kit of claim 1, wherein the distalmost flared edge of the flared wall is attached to the cover portion having a circular profile, the circular profile having a diameter between about 1.5 cm and about 7 cm.

4. The anal irrigation kit of claim 1, wherein the multiple openings are arranged on the cover portion, wherein the anal irrigation kit is configured to direct liquid streams in different directions through the multiple openings at a pressure sufficient to stimulate a rectal wall, wherein the multiple openings are configured such that at least one of the multiple openings directs the liquid stream toward the rectal wall at a pressure sufficient to trigger a reflex reaction.

5. The anal irrigation kit of claim 4, wherein the multiple openings include a center opening arranged proximate a center of the cover portion and at least three peripheral openings arranged along a periphery of the cover portion, wherein each of the peripheral openings directs a fluid stream toward a different location along a polar coordinate.

6. The anal irrigation kit of claim 1, wherein the irrigation liquid reservoir, the hand pump and the flow manifold are connected via a series of tubing portion.

7. The anal irrigation kit of claim 1, wherein at least one of the multiple openings is circumferentially located about the distalmost edge of the flared wall.

8. The anal irrigation kit of claim 1, wherein the hand pump has a first one-way valve located proximate the top inlet and a second one-way valve located proximate the bottom outlet.

9. The anal irrigation kit of claim 1, wherein the irrigation liquid reservoir includes a hole, wherein a circumference of the hole is of a distance to accommodate a user'"'"'s thumb.

10. The anal irrigation kit of claim 1, further including a temperature indicator located on a wall of the irrigation liquid reservoir.

11. A handheld transanal irrigation kit having a proximal end and a distal end comprising:

an irrigation liquid reservoir, the irrigation liquid reservoir having an inlet, a first wall and a second wall, the first wall and the second wall are sealed together along peripheral edges to define a cavity;

a hand pump, the hand pump including a rigid outer wall, a top inlet and a bottom outlet, and having a first one-way valve located proximate the top inlet and having a second one-way valve located proximate the bottom outlet;

a resilient flow manifold, the flow manifold being constructed of a resilient material, the flow manifold having a flow lumen therethrough, the flow manifold having an entry end proximate the hand pump and a distalmost exit end, the distalmost exit end having a flared-end portion including a flared wall with an outer surface area configured to sealingly engage a rectum as fluid flows through the flow manifold and a cover portion attached to a distalmost flared edge of the flared wall, wherein a flow lumen is defined by an enclosed inner surface area of the flared-end portion between the flared wall and the cover portion and a plurality of openings are arranged about the distalmost flared edge of the flared wall in fluid communication with the flow lumen.

12. A method of emptying a bowel, comprising the steps of:

providing an anal irrigation kit including an irrigation liquid reservoir, a hand pump, and a soft flow manifold including multiple openings,

the soft flow manifold further including a distalmost flared-end portion including a flared wall with an outer surface area configured to sealingly engage a rectum as fluid flows through the flow manifold and a cover portion attached to a distalmost flared edge of the flared wall,

wherein a flow lumen is defined by an enclosed inner surface area of the flared-end portion between the flared wall and the cover portion and a plurality of the multiple openings are arranged about the distalmost flared edge of the flared wall in fluid communication with the flow lumen;

folding the soft flow manifold and inserting the folded soft flow manifold into the rectum; and

instilling an irrigation liquid and stimulating a rectal wall simultaneously by operation of the hand pump.

13. The method of claim 12, wherein the soft flow manifold is formed of a resilient material, and configured to self-deploy once the folded soft flow manifold is in the rectum.

14. The method of claim 12, wherein the step of instilling an irrigation liquid and stimulating a rectal wall includes expelling liquid streams through the multiple openings, such that at least some of the liquid streams are directed to different areas of the rectal wall at a stimulatory pressure to trigger a defecatory response.

15. The method of claim 12, wherein the flared-end portion is folded to increase a bending stiffness of the flared-end portion for insertion into the rectum, wherein the flared-end portion self-deploys in the rectum without a user intervention to provide for hands-free retention of the flow manifold in the rectum during the step of instilling an irrigation liquid.

16. The method of claim 12, wherein the method empties the bowel by mobilizing bowel contents in the irrigation liquid and simultaneously stimulating a defecatory response by expelling irrigation liquid streams at multiple locations along the rectal wall at a stimulatory pressure.