Containment devices for treatment of intestinal fistulas and complex wounds

Inventors

Obst, Andrew ThomasObst, Maryanne

Assignees

Fistula Solution Corp

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Publication Number

US-11426302-B2

Patent

Publication Date

2022-08-30

Expiration Date


Abstract

Devices to contain and control the effluent or gastric juices of intestinal fistulas, other fistulas, stomas, and other wounds. The device includes a flexible fluid containment lineal strip defining a fluid containment wall which collapses when pressure is applied to the wound dressing, means for forming the lineal strip into any open or closed shape to fit wounds of various shape and size, means for joining the lineal strip to create closed effluent containment areas, means for creating a seal at the wound bed interface whereby effluent is contained, and means for interfacing with a pouch appliance to capture effluent and bowel contents until bowel contents can be emptied into a toilet or other waste receptacle.

Core Innovation

The invention provides a customizable device to manage effluent from a wound that includes a fistula, ostomy, or wound opening and a wound bed. The device provides a containment boundary that isolates the fistula, ostomy, or wound opening from negative pressure applied to the wound bed.

The invention specifically uses a trimmable and flexible lineal elongate strip that defines a fluid containment wall configured to collapse along an axis perpendicular to the length from a first height to a second height less than the first height when subjected to negative pressure. The customizable device includes a sealing flange extending from a first longitudinal edge of the fluid containment wall and an appliance interface flange extending from a second longitudinal edge of the fluid containment wall.

The device is configured for an open shape containment configuration and for a closed shape containment configuration. In the open shape containment configuration, the first end and second end are positioned in the wound bed adjacent to intact tissue so that the device provides a portion of the containment boundary surrounding the fistula, ostomy, or wound opening, while the intact tissue provides a remaining portion. In the closed shape containment configuration, the first end and second end are positioned adjacent to one another such that the device provides the entire containment boundary surrounding the fistula, ostomy, or wound opening.

Claims Coverage

The partial content identifies three independent claims centered on an effluent-management containment boundary that isolates a fistula, ostomy, or wound opening from negative pressure. Across the independent claims, the main inventive features are the trimmable flexible collapsible lineal strip with flanges, open and closed containment configurations, sealing and collapse under negative pressure, and a kit with a coupled wound dressing and instructions.

Collapsible trimmable lineal strip fluid containment wall with negative-pressure collapse

A trimmable and flexible lineal elongate strip defining a fluid containment wall and having a length, a first end, and a second end, the fluid containment wall being configured to collapse along an axis perpendicular to the length from a first height to a second height less than the first height when subjected to negative pressure.

Dual flanges for wound-bed sealing and appliance interface

A sealing flange extending from a first longitudinal edge of the fluid containment wall and along at least a portion of the length of the lineal elongate strip, and an appliance interface flange extending from a second longitudinal edge of the fluid containment wall and along at least a portion of the length of the lineal elongate strip.

Open and closed shape containment configurations using intact tissue or full boundary

A configuration to be positioned in the wound in one of an open shape containment configuration and a closed shape containment configuration, wherein the open shape configuration positions the first end and second end in the wound bed adjacent to intact tissue such that the device provides a portion of the containment boundary surrounding the fistula, ostomy, or wound opening and intact tissue provides a remaining portion, and wherein the closed shape configuration positions the first end and second end adjacent to one another such that the device provides the entire containment boundary.

Containment boundary physically isolating fistula, ostomy, or wound opening from negative pressure

The containment boundary physically isolates the fistula, ostomy, or wound opening within the wound bed, such that the containment boundary isolates the fistula, ostomy, or wound opening from negative pressure applied to the wound bed.

Method sealing and collapsing the containment wall under negative pressure

Positioning the device in an open shape containment configuration or a closed shape containment configuration, sealing the containment boundary so that the fistula, ostomy, or wound opening are physically isolated within the wound bed, and applying negative pressure to collapse the interior fluid containment wall from the first height to the second height.

Kit with coupled wound dressing and instructions for cut, conforming shape, and flush flange positioning

A kit comprising a device to manage effluent drainage, an elongate strip defining a sidewall configured to collapse from a first height to a second height less than the first height, a sealing flange extending from a first longitudinal edge of the sidewall, and an appliance interface flange extending from a second longitudinal edge of the sidewall, a length of wound dressing coupled to the sidewall, and instructions indicating administration by cutting the strip to a length sufficient to at least partially surround the wound opening, manipulating the strip to a shape conforming to the wound opening such that the wound sealing flange is flush with the wound bed, the attached wound dressing fills the wound bed, and the appliance interface flange is flush with a top surface of the wound dressing opposite the wound sealing flange, and positioning the device with attached wound dressing in the wound such that the sidewall of the strip isolates the fistula from the attached wound dressing.

Across the independent claims, coverage centers on a customizable, collapsible fluid containment wall formed by a trimmable flexible lineal strip with wound sealing and appliance interface flanges, configurable into open or closed containment boundaries to physically isolate a fistula, ostomy, or wound opening from negative pressure. The method claim adds sealing and applying negative pressure to collapse the containment wall, and the kit claim adds a coupled wound dressing and instructions for cutting, shaping, and positioning with flush flange alignment.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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