Marine Polymer Technologies, Inc. (Danvers, MA) Brigham & Women’s Hospital, Inc. (Boston, MA)

This invention is generally related to a method and device to heal wounds and improve hemostasis. In particular the invention is related to a device that comprises the polymer material that is placed on a scaffold that facilitates hemostasis and wound healing. Particularly, the invention contemplates the use of these scaffolds with a device for negative pressure.

This invention is related to a wound-healing device that is able to be used using negative pressure. It is composed of a support which disperses pressure evenly across the wound, and an hemostatic agent that is attached. In one instance, the support is a screen. A second embodiment may use foam supports. The hemostatic agent may be any hemostatic agent that is known comprising fibrin, thrombin, cryoprecipitate, oxidized regenerated cellulose platelets, factors that trigger blood clotting, including Factor VII, VIII, IX. In a preferred embodiment the hemostatic agent is collagen; In another preferred embodiment the haemostatic agent comprises poly-N-acetylglucosamine.

The invention also includes a wound healing system that includes (a) a system for delivering negative pressure to wounds and (b) an wound healing device that consists of a screen or other open-pore structure scaffold, coated with a hemostaticagent. One of the features of the invention is using Poly-N-acetylglucosamine (pGlcNac) to act as a hemostatic agent. In one embodiment the wound healing appliance consists of an open pore polyurethane foam coated on its active surface with Poly-N-acetylglucosamine nanofibers. Another type of device for healing wounds is a pGlcNac coated screen.

One aspect of the invention’s wound-healing system comprises a wound-healing device that can be used for wound healing, like a pGlcNac screen or foam and an impermeable cover a connecting tub, and a vacuum source.

In another aspect, the invention comprises a system that provides sub-atmospheric pressure to wounds to aid in hemostasis and wound healing. The invention includes: (a) a device that can deliver an air pressure within the range from 0 to 250 millimeters Hg; (b) seal that’s semipermeable and covers the wound;(c) an elastomer tube that connects the device to the seal; and (d) an wound healing device that consists of (i)) the support to ensure the uniform distribution of pressure in the wound, and (ii) an agent that acts as a hemostatic to the screen.

In one embodiment the wound healing appliance comprises a hemostatic agent comprising poly-N-acelylglucosamine with a mean fiber size of about less than 10 microns. It is preferred that the size of the fiber is between 2 and 4 microns. The size of the wound healing device will be determined by the use and the support type. In one embodiment a thin film of poly-N-acelylglucosamine would act as its own scaffold and be absorbed into the wound site. In a different way, the pGlcNac could be placed on a wire mesh support.

Another embodiment allows the pGlcNac to be placed on or inside an existing scaffold. This scaffold should be porous, like one that is sufficiently porous to allow cellular development. The process of making such porous sponges is a well-known process in the art. Generally, thesponge would be made by lyophilization and will typically have a pore of greater than 10 microns or less than 500 microns. preferring pores that range from 50-150 microns. It is best with pores of around 100 microns.

In another embodiment the hemostatic agent may be composed of collagen with the average fiber length of 0.01 to 5 microns. The hemostatic agent may also be composed of collagen Type I. A different form of hemostaticagent includes collagen that has been dispersed using a solution higher than pH 3.2. In yet another embodiment the hemostatic agent is comprised of collagen with biodegradation rates of 0.5 to 10 days. A different type of hemostaticagent contains collagen with an average thickness of 0.01 to 100 microns.

In a further aspect of the system of the invention can be comprised of a hemostatic agents comprised of a material selected from the group consisting of fibrin, thrombin, oxidized regenerated cellulose, chitin, chitosan, calcium alginate,cryoprecipate, platelets and blood clotting cascade factors including Factor VII, VIII, IX

In a further aspect, the invention comprises a system that applies sub-atmospheric pressure on the wound for the purpose of healing the wound and hemostasis. This includes an apparatus that can deliver a vacuum pressure in the range between 0 and 250 millimeters Hg; a sealing device that is can be smiperpermeable, which covers the wound; a tube connecting the appliance to the seal and an appliance in which it is hemostatic and aids in wound healing and also has a bioreactivity score of less than 1.5. In a preferred embodiment the appliance has abioreactivity of less than 1.0 and, in the best case, less than 0.6, even more preferably less than 0.5 and most preferably about 0.0 or below when compared to high density polyethylene or any other suitable controls.

The invention also includes an approach to treating a wound by using the system(s). In one way, the invention provides a method for treating a wound that includes providing a hemostatic apparatus with a support to facilitate an even distribution of pressure inside the wound and an agent for hemostatics attached to the support, applying the hemostatic device to the wound to at least partially cover the wound and applying a vacuum pressure in the range between 0 and 250 millimeters Hg to thehemostatic appliance as well as the wound. Preferably, the hemostatic appliance is directly applied to the wound before applying vacuum pressure or negative pressure to it. In a preferred form, the hemostatic appliance is applied at least 6 hours, or at minimum 8 hours, at minimum 12 hours, at least 16 hours, minimum 18 hours, minimum 20 hours, at most 24 hours, at least 30 hours, and at least 36 hours, and at least 42 hours or at most 48 hours prior to the applicationof negative pressure to the wound and/or the hemostatic appliance. The hemostatic device should be placed on the wound 24 hours before applying pressure to the wound.

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