Assemblies, systems, and methods for vacuum assisted internal drainage during wound healing

Inventors

BENGTSON, BRADLEY

Assignees

Ic Surgical Inc • Surgical Design Solutions LLC

Abstract

Assemblies, systems, and methods convey fluid from an internal wound site or body cavity by applying negative pressure from a source outside the internal wound site or body cavity through a wound drain assembly that is placed directly inside the internal wound site or body cavity.

Core Innovation

The invention relates to a wound drain system for a wound defined by an interior dead space having a volume enclosed between interior tissue surfaces consisting of muscle, connective, or skin tissue containing blood vessels that have been separated by surgery or trauma within a body beneath substantially intact skin. Extracellular exudates comprising blood, serous fluid, and byproducts of wound healing including blood clots escape from the blood vessels and can accumulate during wound healing. The system is sized and configured for placement entirely within the interior dead space under substantially intact skin.

The wound drain system includes a housing comprising an inert, non-tissue adherent material, enclosing an open interior, and having perforations communicating with the open interior. The perforations are sized and configured to pass the extracellular exudates without substantial plugging, with the perforations being sized to comprise a mean pore diameter of about 0.5 mm to about 5 mm. An open cell material is carried within the open interior to take in the extracellular exudates conveyed through the perforations into the open interior.

Tubing is coupled to the open interior and extends through a percutaneous incision in the substantially intact skin to a location outside the body, where it is coupled to a source of negative pressure to convey negative pressure into the open interior for application through the perforations internally throughout the interior dead space. In response to the applied negative pressure, the extracellular exudates taken in by the open cell material are conveyed from the interior dead space to decrease the volume of the dead space and subsequent seroma formation.

The applied negative pressure also draws together the separated interior tissue surfaces to promote adherence of the tissue surfaces and a normal wound healing process. In one claim, the perforations comprise slits or slots that emulate a one-way valve that is normally substantially closed in the absence of applied negative pressure and that is opened in response to applied negative pressure.

Claims Coverage

The document provides two independent claims that share a common core: an internally placed wound drain system beneath substantially intact skin using an inert, non-tissue adherent housing with perforations and an open cell material, connected to externally applied negative pressure via tubing, to reduce dead space and seroma and draw separated tissue surfaces together for healing. Across the independent claims, the inventive features emphasize perforation sizing and plugging avoidance, and valve-emulating perforation behavior.

Both independent claims cover an internally placed wound drain beneath substantially intact skin using an inert, non-tissue adherent housing with perforations and an open cell material, connected to externally applied negative pressure via tubing so that extracellular exudates are conveyed out to decrease dead space and seroma formation and separated tissue surfaces are drawn together to promote adherence and a normal wound healing process. Claim 1 further specifies mean pore diameter for plugging avoidance, while Claim 2 adds perforations emulating a normally closed, one-way valve behavior that opens in response to applied negative pressure.

Stated Advantages

Documented Applications