Fecal management appliance and method and apparatus for introducing same
First Claim
1. A waste management appliance for the rectum or stoma comprising an elongated tubular element having a substantially unobstructed distal end portion with an exterior surface, and a proximal end;
- an inflatable substantially toroidal shaped balloon comprising an opening defined by an interior wall, substantially the entire surface of said interior wall of said balloon opening being fixed to and surrounding said exterior surface of said distal end portion of said tubular element;
an inflation lumen having a distal end portion substantially co-extensive with said distal end portion of said tubular element such that said balloon surrounds both said distal end portion of said inflation lumen and said distal end portion of said tubular element, said inflation lumen being connected to the interior of said balloon through a passage in said balloon wall portion and a second externally accessible end portion so as to permit inflation of said balloon;
an irrigation lumen comprising a portion formed as an integral part of said distal end portion of said element, said irrigation lumen comprising a first end situated proximate the edge of said distal end portion of said element and a second externally accessible end portion so as to permit the introduction of an irrigation fluid;
said balloon wall portion being substantially uninterrupted except for said passage;
a waste collection receptacle; and
means for detachably mounting said receptacle to said proximal end of said element, wherein said distal end portion of said element and said balloon are formed of entirely soft, compliant material.
10 Assignments
0 Petitions
Accused Products
Abstract
The end of the elongated tubular element of the appliance that is designed to be inserted into a body cavity or vessel is formed entirely of soft, compliant material. That end carries an inflatable balloon formed in its fully inflated shape. 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.
151 Citations
32 Claims
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1. A waste management appliance for the rectum or stoma comprising an elongated tubular element having a substantially unobstructed distal end portion with an exterior surface, and a proximal end;
- an inflatable substantially toroidal shaped balloon comprising an opening defined by an interior wall, substantially the entire surface of said interior wall of said balloon opening being fixed to and surrounding said exterior surface of said distal end portion of said tubular element;
an inflation lumen having a distal end portion substantially co-extensive with said distal end portion of said tubular element such that said balloon surrounds both said distal end portion of said inflation lumen and said distal end portion of said tubular element, said inflation lumen being connected to the interior of said balloon through a passage in said balloon wall portion and a second externally accessible end portion so as to permit inflation of said balloon;
an irrigation lumen comprising a portion formed as an integral part of said distal end portion of said element, said irrigation lumen comprising a first end situated proximate the edge of said distal end portion of said element and a second externally accessible end portion so as to permit the introduction of an irrigation fluid;
said balloon wall portion being substantially uninterrupted except for said passage;
a waste collection receptacle; and
means for detachably mounting said receptacle to said proximal end of said element, wherein said distal end portion of said element and said balloon are formed of entirely soft, compliant material. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 24, 25, 26, 27, 28, 29, 30, 31, 32)
- an inflatable substantially toroidal shaped balloon comprising an opening defined by an interior wall, substantially the entire surface of said interior wall of said balloon opening being fixed to and surrounding said exterior surface of said distal end portion of said tubular element;
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23. The appliance of 21 wherein said section of said sleeve has a substantially bulbous shape.
Specification