Fecal management appliance and method and apparatus for introducing same

• US 8,827,970 B2
• Filed: 08/02/2011
• Issued: 09/09/2014
• Est. Priority Date: 09/09/2003
• Status: Active Grant

• Current Assignee: Convatec Technologies, Inc. (ConvaTec Group Plc)
• Original Assignee: Convatec Incorporated (ConvaTec Group Plc)
• Inventors: Gregory, Christopher C.
• Primary Examiner(s): HAND, MELANIE JO
• Application Number:
  US13/196,375
• Publication Number:
  US 20110313378A1
• Time in Patent Office: 1,134 Days
• Field of Search: 604/96.01, 604/97.01, 604/97.02, 604/99.01, 604/102.01, 604/104, 604/131, 604/134, 604/327, 604/332
• US Class Current: 604/317
• CPC Class Codes: A61F 5/442 having irrigation ports or means irrigators A61M3/02
• CPC Class Codes: A61F 5/445 Colostomy, ileostomy or urethrostomy devices A61F5/441, A61F5/442, A61F5/443 take precedence
• CPC Class Codes: A61M 2210/1064 Large intestine
• CPC Class Codes: A61M 25/0119 Eversible catheters
• CPC Class Codes: A61M 3/0283 with at least two inner passageways, a first one for irrigating and a second for evacuating suction-irrigation systems A61M1/77; aspiration tips with fluid supply means A61M1/85; for negative pressure wound therapy A61M1/92
• CPC Class Codes: A61M 3/0295 with inflatable balloon
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008

Abstract

The end of the elongated tubular element of the appliance that is designed to be inserted into a body cavity is formed entirely of soft, compliant material. That end carries an inflatable balloon made of non-expandable material, formed in the fully inflated shape, to prevent overexpansion. The balloon is inflated to a predetermined low pressure level to prevent pressure necrosis in the adjacent tissue. A method and apparatus for introducing the soft end of the appliance into the body cavity are also provided. The introducer apparatus includes rigid core surrounded by a soft, compliant sleeve. The sleeve extends beyond the rigid core to form an invertable section. The soft end of the appliance is situated adjacent the apparatus, the balloon is wrapped around the apparatus, and the sleeve section is inverted over the appliance, compressing the balloon and forming a soft, rounded insertion tip. The unit is then introduced into the body cavity. After the appliance is separated from the apparatus, the apparatus is withdrawn.

Claims

1. A waste management appliance comprising an elongated tubular element having a distal end portion, and a proximal end;

an inflatable balloon fixed to and surrounding said distal end portion of said tubular element, said distal end portion of said tubular element and said balloon both being formed entirely of soft, compliant material;

an inflation lumen connected to the interior of said balloon so as to permit inflation of said balloon;

a waste collection receptacle; and

means for detachably mounting said receptacle to said proximal end of said element, wherein said balloon is formed of non-expandable material and is fabricated in its fully inflated shape.

2. The appliance of claim 1 wherein said balloon is adapted to be inflated into a toroidal shape.

3. The appliance is claim 1 wherein said balloon is formed of silicone.

4. A waste management appliance comprising an elongated tubular element having a distal end portion adapted to be introduced into a body cavity, and a proximal end;

an inflatable balloon formed of soft, compliant material fixed to and surrounding said distal end portion of said tubular element;

an inflation lumen connected to the interior of said balloon so as to permit inflation of said balloon;

a waste collection receptacle; and

means for mounting said receptacle to said proximal end of said element, wherein said balloon material is non-expandable and is soft and compliant enough to be fully compressed as the distal end portion of the tubular element is introduced into the body cavity.

5. A waste management appliance comprising an tubular element having a distal end portion, a proximal end and an elongated body extending therebetween, said body having an interior surface;

an inflatable balloon fixed to and surrounding said distal end portion of said tubular element; and

an inflation lumen connected to the interior of said balloon so as to permit inflation of said balloon, said inflation lumen being formed as an integral part of said interior surface of said body and extending substantially the entire length of said body.

6. A waste management appliance comprising an tubular element having a distal end portion, a proximal end and an elongated body extending therebetween, said body having an interior surface;

an inflatable balloon fixed to and surrounding said distal end portion of said tubular element; and

an irrigation lumen having a open end situated proximate the edge of said distal end portion, said irrigation lumen being formed as an integral part of said interior surface of said body and extending substantially the entire length of said body.