Device for management of an open abdomen

Inventors

De Rezende Neto, João Baptista

Assignees

St Michaels HospitalUnity Health Toronto

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Publication Number

US-10524793-B2

Patent

Publication Date

2020-01-07

Expiration Date


Abstract

A device for management of an open abdomen includes a belt having first and second end portions. The belt is positionable to extend partially around a patient's torso in a taut configuration with the end portions positioned on opposed sides of an incision in the patient's abdomen. A first connector is at the first end portion and a second connector is at the second end portion. The connectors are positionable adjacent each other on the opposed sides of the incision. At least one cinching device is connected to and extends between the connectors. The cinching device is positionable to extend over the incision when the connectors are positioned adjacent each other on opposed sides of the incision. The cinching device is adjustable to cinch the end portions towards each other to hold the incision in an at least partially closed position.

Core Innovation

The invention provides a device for management of an open incision in a patient by wrapping a belt around the patient in a taut configuration such that a first end portion and an opposed second end portion are positioned on opposed sides of the incision. The belt extends partially around the patient, with the first end portion and the second end portion located on the opposed sides of the incision. The device uses a first connector and a second connector positioned adjacent each other on the opposed sides when the belt is in the taut configuration.

Each connector includes a belt lock that holds a corresponding belt end portion, where the first belt lock comprises a clamp adapted to hold the first end portion and the second belt lock comprises a clamp adapted to hold the second end portion. At least one cinching device is connected to and extending between the first connector and the second connector, and the cinching device is positionable to extend over the incision. The cinching device is adjustable to cinch the first end portion and second end portion towards each other to hold the incision in an at least partially closed position.

The invention also provides a kit of parts that includes the belt, the first connector and second connector with belt locks and clamps, and at least one adjustable cinching device configured to extend over the incision when the connectors are adjacent on opposed sides. The clamp structure includes a hinged clamp with an open position and a closed position, and a gripping mechanism that includes spikes and corresponding openings that receive the spikes when the clamp is closed. The disclosed approach addresses an open abdominal incision by bringing the incision sides toward each other into at least a partially closed configuration.

Claims Coverage

The partial content includes three independent claims: a device claim, a method claim, and a kit-of-parts claim, each centered on an open incision management system using a taut belt, opposed connectors with belt locks, and an adjustable cinching device that holds the incision at least partially closed.

Taut belt around opposed incision sides with belt ends held on connectors

A belt having a first end portion and an opposed second end portion, positionable to extend partially around the patient in a taut configuration with the first end portion and the second end portion positioned on opposed sides of the incision.

Opposed connectors with belt locks and clamps

A first connector and a second connector, where the first connector comprises a first belt lock holding the first end portion and the second connector comprises a second belt lock holding the second end portion; the first belt lock comprises a clamp adapted to hold the first end portion and the second belt lock comprises a clamp adapted to hold the second end portion.

Adjustable cinching device extending over the incision to cinch incision sides together

At least one cinching device connected to and extending between the first connector and the second connector, positionable to extend over the incision, and adjustable to cinch the first end portion and second end portion towards each other to hold the incision in an at least partially closed position.

Positioning, securing connectors, cinching, and temporarily holding the incision closed

Positioning a belt to extend partially around the patient in a taut configuration; securing a first connector to a first end portion of the belt and securing a second connector to a second end portion of the belt; cinching the belt to bring the first side of the incision and second side of the incision towards each other; and temporarily securing the belt in the cinched configuration to temporarily hold the incision in an at least partially closed configuration.

Kit of parts including belt, opposed connectors, and adjustable cinching device

A kit of parts comprising a belt with first and opposed second end portions; a first connector and a second connector with belt locks and clamps adapted to hold corresponding belt end portions; and at least one cinching device adapted to be connected to the first and second connectors and adjustable to cinch the first end portion and second end portion towards each other.

Across the independent claims, the shared inventive concept is managing an open incision by using a taut belt with opposed connectors that employ clamps and belt locks to hold belt ends, together with an adjustable cinching device that extends over the incision and cinches the opposed incision sides toward each other into at least a partially closed configuration.

Stated Advantages

Reduced risks of open abdomen outcomes.

Improved chance of definitive closure.

Stabilization without creating additional abdominal wounds.

Progressive closure versus negative pressure alone, with reduced abdominal wall defect width at closure.

No device-related complications were reported in the randomized controlled trial.

Documented Applications

Management of an open abdominal incision by holding the incision at least partially closed using the belt-and-connector and adjustable cinching device approach, as supported by pig model results and human randomized controlled trial results.

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