Device for the application of surgical materials to tissue
Inventors
Pacifico, John • Do, Frank • Kronenthal, Richard L. • Darr, Aniq
Assignees
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Publication Number
US-10751036-B1
Publication Date
2020-08-25
Expiration Date
Abstract
The invention relates to a device comprising a surgical material and a support material and related methods for the application of the surgical material to a wound or surgical site using the device.
Core Innovation
The invention provides a surgical device in the form of a fabric or film that provides mechanical assistance for the application of a surgical material to a wound or surgical site. The device includes a ribbon or sheet of surgical material selected from hemostatic material, void filler, bone graft extender, bone cement, surgical sealant, surgical adhesion barrier, anti-surgical adhesion agent, antimicrobial, analgesic, antineoplastic, anti-inflammatory, radiopaque, osteoconductive material, osteoinductive material, and any combination thereof. The device further includes support material that comprises two separate layers that surround the surgical material.
The surgical material is a composition in the form of a putty that is moldable and shapeable at room temperature and suitable for the mechanical hemostasis of hard tissue. The disclosed support-material construction enables exposure of a surgical-material surface by removing one or both support layers, so the surgical material can be applied onto an actively bleeding surface of bone or other tissue. The support layers are described as capable of being non-adhesive to gloves, and the support material can be absorbable or non-absorbable.
The disclosure expands the surgical material chemistries and configurations, including putty/paste surgical material sandwiched as a ribbon or sheet between two support-layer films or meshes, with optional components such as drugs and adhesion-barrier/osteoconductive/osteogenic agents. Examples described include self-assembling peptide-based nanostructure adhesives/hemostats and isocyanate-based curable polymer systems that cure in situ into hardened, adhesive polymer compositions, including two-component reactive device embodiments.
Claims Coverage
The independent claim covers a surgical device defined by a two-layer support surrounding a room-temperature moldable, shapeable putty surgical material provided as a ribbon or sheet, configured for mechanical hemostasis of hard tissue. The dependent claims refine the device by viscosity categories, support-layer exposure, and specific use outcomes including anastomosis connection and sealing, with additional refinements to support materials and film compositions as stated.
Two-layer supported ribbon or sheet device for mechanical hemostasis
A surgical device in the form of a fabric or film comprising a ribbon or sheet of surgical material surrounded by support material comprising two separate layers, wherein the surgical material is a putty moldable and shapeable at room temperature and suitable for mechanical hemostasis of hard tissue.
Viscosity-selected surgical material putty
The surgical material is a composition in the form of a putty that is high viscosity material or low viscosity material.
Non-absorbable low-surface-energy support layers
The support material comprises a non-absorbable low-surface-energy fabric or a non-absorbable polymeric film material.
Selected polymeric film materials for the support
The support material comprises a polymeric film made from one or more selected materials including polyurethane, poly(propylene), poly(tetrafluoroethene), or polysiloxane.
Expose surgical-material surface by removing a support layer
A method removes a first layer of the support material from the surgical material to expose a surface before use.
Connection and sealing of surgical tissue anastomosis by an exposed sealant surface
A method connects and seals a surgical tissue anastomosis by pressing an exposed surface of a surgical sealant from a surgical device onto the anastomosis tissue surface until the sealant adheres, thereby forming the connection and seal.
Overall, the claim set centers on a two-layer supported ribbon/sheet surgical device using a room-temperature moldable putty surgical material for mechanical hemostasis of hard tissue, with refinements based on viscosity selection, non-absorbable low-surface-energy support, defined polymeric film options, exposure of the surgical-material surface by removing support layers, and a specific outcome of anastomosis connection and sealing via an exposed sealant surface.
Stated Advantages
Provides mechanical assistance for the application of a surgical material to a wound or surgical site.
Provides mechanical hemostasis of hard tissue.
Enables connection and sealing of a surgical tissue anastomosis by pressing an exposed sealant surface until adhesion.
Documented Applications
Mechanical hemostasis of hard tissue on an actively bleeding surface.
Mechanical hemostasis of soft tissue and actively bleeding surfaces.
Connection and sealing of a surgical tissue anastomosis by pressing an exposed surface of a surgical sealant from a surgical device onto the anastomosis tissue surface until adhesion.
Preventing surgical adhesions of soft tissue.
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