US-12616774-B2 - Lyophilized hydrogel wound dressing

Abstract

A wound dressing composition having a first layer of a lyophilized hydrogel layer having hydrolyzed collagen and hydrolyzed hyaluronic acid ingredients, wherein the first layer has a water content of 10 percent or less and is configured to lay onto a wound. The first layer can be cut or molded to various shapes such as a rectangle, a square, a polygon, an oval or a circle. The first layer is hermetically sealed in a cover or barrier and placed in final packaging. Alternatively, one or more additional layers are stacked onto the first layer, each additional one or more layers having a water content greater than that of the first layer.

Inventors

• Timothy Ganey

Assignees

• BONE PHARM, LLC

Dates

Publication Date

20260505

Application Date

20221108

Claims (9)

1. 1 . A multiple layer wound dressing composition comprising: a first layer of a lyophilized hydrogel layer having hydrolyzed collagen and hydrolyzed hyaluronic acid ingredients, the first layer having a water content of 10 percent or less and configured to lay onto a wound surface; one or more additional layers of lyophilized hydrogel stacked onto the first layer, each additional one or more layers having a water content greater than that of the first layer; and removable interleaved barrier sheets between the layers to prevent degradation of the water content of each layer.
2. 2 . The composition of claim 1 , wherein a plurality of the additional layers adjacent the first layer has a water content of 25 percent to 50 percent.
3. 3 . The composition of claim 2 , wherein the removable interleaved barrier sheets between the layers have a tear seam along one of two sides or ends that allows the layers to be removed at the time of use.
4. 4 . The composition of claim 1 , wherein one of the additional layers adjacent the first layer has a water content of 25 percent to 50 percent.
5. 5 . The composition of claim 1 , wherein one layer of the additional layers has a higher water content of 50 percent to 90 percent.
6. 6 . The composition of claim 1 , wherein the removable interleaved barrier sheets between the layers have a tear seam along one of two sides or ends that allows the layers to be removed at the time of use.
7. 7 . The composition of claim 1 , wherein each layer is cut or molded to various shapes such as rectangles, squares, polygons, ovals or circles.
8. 8 . The composition of claim 1 , wherein the hydrogel layers further include one or more of a preservative, antimicrobial, anti-fungal, mechanical stabilizer, fragrance, protectant, or elemental metal.
9. 9 . A method of applying a multiple layer wound dressing composition comprising the steps of: providing a first layer of a lyophilized hydrogel layer having hydrolyzed collagen and hydrolyzed hyaluronic acid ingredients with a water content of 10 percent or less; providing one or more additional layers of lyophilized hydrogel stacked onto the first layer with removable interleaved barrier sheets between the layers to prevent degradation of the water content of each layer, each additional one or more layers having a water content greater than that of the first layer; removing the interleaved barrier sheets at a tear seam along one of two sides or ends of the interleaved barrier sheets; and pulling the interleaved barrier sheets apart and away from the layers allowing the layers to lie on top of one another over a wound surface.

Description

TECHNICAL FIELD The present invention relates to a lyophilized hydrogel wound dressing, more particularly, a multi-layered laminated product. BACKGROUND OF THE INVENTION The use of hydrogel wound dressings is well known. Hydrogels are known as water-swollen polymeric materials that maintain a distinct three-dimensional structure. They can be composed of complex hydrophilic polymers and often have a high water content, often as high as 90 percent water. They are among the first biomaterials designed for use in the human body, traditional methods for attaining structural integrity include crosslinking copolymerization, crosslinking of reactive polymer precursors, and crosslinking via polymer-polymer reaction. By definition hydrogels demonstrate a predominance of water. Compositions can include linear polymers, spheroids and may include voids as negative space. Hydrogel wound dressings are non-adherent and provide moisture to the wound, creating a moist environment that promotes autolytic debridement, granulation and epithelialization. Hydrogels can also absorb moisture from a wound. Based on the material used for their fabrication, hydrogels can be subdivided into two main groups-natural and synthetic. As described herein, the present invention discloses a unique wound dressing made of a layer or distinct layers varying in water content and fluid absorption capacities. SUMMARY OF THE INVENTION A wound dressing composition having a first layer of a lyophilized hydrogel layer having hydrolyzed collagen and hydrolyzed hyaluronic acid ingredients, wherein the first layer has a water content of 10 percent or less and is configured to lay onto a wound. The first layer can be cut or molded to various shapes such as a rectangle, a square, a polygon, an oval or a circle. The first layer is hermetically sealed in a cover or barrier and placed in final packaging. In another embodiment, a multiple layer wound dressing composition has a first layer of a lyophilized hydrogel layer having hydrolyzed collagen and hydrolyzed hyaluronic acid ingredients, the first layer having a water content of 10 percent or less and configured to lay onto a wound surface, and one or more additional layers of lyophilized hydrogel stacked onto the first layer, each additional one or more layers having a water content greater than that of the first layer. The composition can further include one or more of a preservative, antimicrobial, anti-fungal, mechanical stabilizer, fragrance, protectant, or elemental metal. One of the additional layers adjacent the first layer has a water content of 25 percent to 50 percent. Alternatively, one layer of the additional layers has a higher water content of 50 percent to 90 percent. The composition further has removable interleaved barrier sheets between the layers to prevent degradation of the water content of each layer and wherein one of the additional layers adjacent the first layer has a water content of 25 percent to 50 percent. Preferably, the layers are made in the absence of hydrogen peroxide. The removable interleaved barrier sheets between the layers have a tear seam along one of two sides or ends that allows the layers to be removed at the time of use, wherein each layer is cut or molded to various shapes such as rectangles, squares, polygons, ovals or circles. A method of applying a wound dressing composition has the steps of providing a first layer of a lyophilized hydrogel layer having hydrolyzed collagen and hydrolyzed hyaluronic acid ingredients with a water content of 10 percent or less hermetically sealed in a cover or barrier; removing the cover or barrier; and placing the first layer on a wound surface. A method of applying a multiple layer wound dressing composition has the steps of providing a first layer of a lyophilized hydrogel layer having hydrolyzed collagen and hydrolyzed hyaluronic acid ingredients with a water content of 10 percent or less; providing one or more additional layers of lyophilized hydrogel stacked onto the first layer with removable interleaved barrier sheets between the layers to prevent degradation of the water content of each layer, each additional one or more layers having a water content greater than that of the first layer; removing the interleaved barrier sheets at a tear seam along one of two sides or ends of the interleaved barrier sheets; and pulling the interleaved barrier sheets apart and away from the layers allowing the layers to lie on top of one another over a wound surface. BRIEF DESCRIPTION OF THE DRAWINGS The invention will be described by way of example and with reference to the accompanying drawings in which: FIG. 1 is an exemplary depiction of a hydrogel composition of the present invention in the form of a rectangular structure. FIG. 2 is an exemplary depiction of the lyophilized hydrogel composition of FIG. 1 shown as a flattened sheet after lyophilization. FIG. 3 is an exemplary depiction of various shapes in which the lyophilized hydrogel