US-12622996-B2 - Wound dressing compositions and uses thereof

US12622996B2US 12622996 B2US12622996 B2US 12622996B2US-12622996-B2

Abstract

The present disclosure relates generally to wound dressing compositions that detect nitric oxide production in a wound upon application. The wound dressing composition comprises a first layer comprising an absorbent layer, a second layer comprising a reaction pad, a third layer comprising a transparent backing film, and optionally a fourth layer comprising a wicking layer. In the wound dressing composition, the second layer comprises a reaction pad of a dried reaction mixture to detect the presence of nitric oxide in a wound. The wound dressing composition can be a visual indicator of the presence of nitric oxide in a wound; a visual indicator of the wounds healing status.

Inventors

Alexander WAITE
Carrina WARD

Assignees

SYSTAGENIX WOUND MANAGEMENT, LIMITED

Dates

Publication Date: 20260512
Application Date: 20190924

Claims (20)

1 . A wound dressing composition comprising a first layer, a second layer, and a third layer: wherein each of the first layer, the second layer, and the third layer comprises a wound-facing side and an environmental-facing side; wherein the first layer comprises an absorbent layer; wherein the second layer comprises a reaction pad including a first reagent configured to react with a second reagent to provide a first color intensity change indicating the presence of nitric oxide, wherein the first reagent is further configured to react with the second reagent to provide a second color intensity change, with continued exposure to wound fluid in the wound dressing, after the first color intensity change, and wherein a ratio of the first reagent to the second reagent is about 10:1; and wherein the third layer comprises a transparent backing film, and wherein the second layer is positioned between the first layer and the third layer, the third layer further comprising a colorimetric indicator strip including a plurality of colors correlated to a quantity of nitric oxide indicated by the first color intensity change and the second color intensity change of the second layer, wherein the plurality of colors include at least a first color intensity correlating to a first nitric oxide quantity, a second color intensity correlating to a second nitric oxide quantity that is greater than the first nitric oxide quantity, and a third color intensity correlating to a third nitric oxide quantity that is greater than the first nitric oxide quantity and the second nitric oxide quantity.
2 . The wound dressing composition of claim 1 , further comprising a fourth layer: wherein the fourth layer comprises a wound-facing side and an environmental-facing side; and wherein the fourth layer comprises a wicking layer, wherein the wound-facing side of the third layer is coupled with the environmental-facing side of the second layer, wherein the wound-facing side of the second layer is coupled with the environmental-facing side of the fourth layer, and wherein the wound-facing side of the fourth layer is coupled with the environmental-facing side of the first layer.
3 . The wound dressing composition of claim 2 , wherein the fourth layer is selected from the group consisting of a superabsorbent polymer, a non-woven carboxymethyl cellulose (CMC) pad, polyester, rayon, nylon, or any combination thereof.
4 . The wound dressing composition of claim 1 , wherein the first layer is selected from the group consisting of a foam pad, a gauze, a nonwoven fabric, a superabsorbent, a hydrogel, and any combination thereof, optionally wherein the foam pad is a polyurethane foam pad.
5 . The wound dressing composition of claim 1 , wherein the third layer is selected from the group consisting of polyurethane, polyalkoxy alkyl acrylate, polyalkoxy alkyl methacrylate, and any combination thereof, optionally wherein the colorimetric indicator strip is included on the environmental-facing side of the third layer.
6 . The wound dressing composition of claim 1 , wherein the second layer is selected from the group consisting of a gauze, a nonwoven fabric, a filter paper, and any combination thereof.
7 . The wound dressing composition of claim 1 , wherein the second layer comprises a dried reaction mixture of the first reagent and the second reagent, wherein the first reagent has the formula: wherein R 1 is NH 2 or OH, and wherein the second reagent has the formula:
8 . The wound dressing composition of claim 1 , wherein the thickness of each the first layer and the second layer is independently about 15 μm to about 500 μm, and/or wherein the thickness of the third layer is about 10 μm to about 1000 μm, about 15 μm to about 500 μm, or about 100 μm to about 500 μm.
9 . The wound dressing composition of claim 1 , wherein the colorimetric indicator strip is coupled to the environmental-facing side of the third layer, wherein the third layer extends beyond each of the first layer and the second layer such that a marginal region of width extends around the wound dressing composition from about 1 mm to about 50 mm, or about 5 mm to about 20 mm, optionally wherein the wound-facing side of the extended region of the third layer is coated with a pressure sensitive medical grade adhesive.
10 . The wound dressing composition of claim 1 , wherein the wound dressing composition is sterile and packaged in a microorganism-impermeable container.
11 . A method for detecting nitric oxide levels in a wound in a subject in need thereof, comprising: administering to the wound a wound dressing composition of claim 1 ; and detecting a colorimetric change in the second layer, wherein the colorimetric change indicates the presence of nitric oxide in the wound.
12 . The method of claim 11 , further comprising determining nitric oxide levels by comparing the color of the second layer to the indicator strip located on the third layer.
13 . The method of claim 11 , further comprising determining nitric oxide levels by comparing the color of the second layer to an indicator strip present on a microorganism-impermeable container for the wound dressing composition.
14 . The method of claim 11 , further comprising determining nitric oxide levels by: receiving an image from an image capture device; comparing a value of at least one feature of the image to a threshold value; and providing an output responsive to comparing the value of the at least one feature to the threshold value; and wherein the output is indicative of wound healing status.
15 . The method of claim 11 , further comprising: determining a first nitric oxide level when the wound dressing composition is administered to the subject in need thereof; and determining a second nitric oxide level about 1 minute to about 24 hours after the wound dressing composition is administered to the subject in need thereof.
16 . A method for monitoring the efficacy of a therapeutic intervention for a subject in need thereof, comprising: administering to the wound a wound dressing composition of claim 1 ; detecting a colorimetric change in the second layer, wherein the colorimetric change indicates the presence of nitric oxide in the wound; determining a first nitric oxide level when the wound dressing composition is administered to the subject in need thereof; and determining a second nitric oxide level about 1 minute to about 24 hours after the wound dressing composition is administered to the subject in need thereof, wherein the therapeutic intervention is effective when the second nitric oxide level is greater compared to the first nitric oxide level.
17 . A method for monitoring the efficacy of a therapeutic intervention for a subject in need thereof, comprising: administering to the wound a wound dressing composition of claim 1 ; detecting a colorimetric change in the second layer, wherein the colorimetric change indicates the presence of nitric oxide in the wound; and determining a nitric oxide level when the wound dressing composition is administered to the subject in need thereof; wherein the therapeutic intervention is effective when the nitric oxide level is increased compared to a pre-determined reference level.
18 . A method for making a wound dressing composition comprising: providing a first layer, a second layer, and a third layer; and combining the first layer, the second layer, and the third layer to make the wound dressing composition, wherein each of the first layer, the second layer, and the third layer comprises a wound-facing side and an environmental-facing side; wherein the first layer comprises an absorbent pad; wherein the second layer comprises a reaction pad; and wherein the third layer comprises a transparent backing film.
19 . A method for making a wound dressing composition comprising: providing a first layer, a second layer, a third layer, and a fourth layer; and combining the first layer, the second layer, the third layer, and the fourth layer to make the wound dressing composition, wherein each of the first layer, the second layer, the third layer, and the fourth layer comprises a wound-facing side and an environmental-facing side; wherein the first layer comprises an absorbent pad; wherein the second layer comprises a reaction pad; wherein the third layer comprises a transparent backing film; and wherein the fourth layer comprises a wicking layer.
20 . A kit comprising the wound dressing composition of claim 1 , an indicator strip for determining nitric oxide levels in a wound, and instructions for use.

Description

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS This application is a U.S. National Phase Application under 35 U.S.C. § 371 of International Patent Application No. PCT/IB2019/058096, filed on Sep. 24, 2019, which claims the benefit of and priority to U.S. Provisional Appl. No. 62/736,116, filed Sep. 25, 2018, the entire contents of each of which is incorporated by reference herein in its entirety. TECHNICAL FIELD The present technology relates generally to wound dressing compositions that detect nitric oxide production in a wound upon application, and over time and methods of using the same. Kits for use in practicing the methods are also provided. BACKGROUND Nitric oxide is a signaling molecule vital to key processes in wound healing such as angiogenesis, vasodilation, and immune response. The nitric oxide levels in a wound and the wound fluid is useful for determining the state of a wound. Specifically, nitric oxide levels at the wound site can indicate whether the conditions within the wound are conducive to healing. Nitric oxide levels can be factored together with clinician judgement to make therapeutic decisions about wound care. Currently, there is an unmet need for wound dressing products that detect nitric oxide production in a wound upon application, and over time. SUMMARY In one aspect, the present disclosure provides a wound dressing composition comprising a first layer, a second layer, and a third layer, wherein the first layer comprises an absorbent layer, the second layer comprises a reaction pad, and the third layer comprises a transparent backing film. In some embodiments of the wound dressing composition of the present technology, the wound-facing side of the third layer is coupled with the environmental-facing side of the second layer, and wherein the wound-facing side of the second layer is coupled with the environmental-facing side of the first layer. In another aspect, the present disclosure provides a wound dressing composition comprising a first layer, a second layer, a third layer, and a fourth layer, wherein the first layer comprises an absorbent layer, the second layer comprises a reaction pad, the third layer comprises a transparent backing film, and the fourth layer comprises a wicking layer. In some embodiments of the wound dressing composition of the present technology, the wound-facing side of the third layer is coupled with the environmental-facing side of the second layer, wherein the wound-facing side of the second layer is coupled with the environmental-facing side of the fourth layer, and wherein the wound-facing side of the fourth layer is coupled with the environmental-facing side of the first layer. Additionally or alternatively, in some embodiments, the first layer is selected from the group consisting of a foam pad, a gauze, a nonwoven fabric, a superabsorbent, a hydrogel, and any combination thereof. Additionally or alternatively, in some embodiments, the foam pad is a polyurethane foam pad. Additionally or alternatively, in some embodiments, the second layer is selected from the group consisting of a gauze, a non-woven fabric, a filter paper, and any combination thereof. Additionally or alternatively, in some embodiments, the third layer is selected from the group consisting of polyurethane, polyalkoxy alkyl acrylate, polyalkoxy alkyl methacrylate, or any combination thereof. Additionally or alternatively, in some embodiments, the fourth layer is selected from the group consisting of a superabsorbent polymer, a non-woven carboxymethyl cellulose (CMC) pad, polyester, rayon, nylon, or any combination thereof. Additionally or alternatively, in some embodiments, a colorimetric indicator strip is included on the environmental-facing side of the third layer. Additionally or alternatively, in some embodiments, the second layer comprises a dried reaction mixture of a first reagent and a second reagent, wherein the first reagent has the formula: and R1 is NH2 or OH, and the second reagent has the formula: Additionally or alternatively, in some embodiments, the thickness of each of the first layer, the second layer, and optionally the fourth layer is independently about 15 μm to about 500 μm. Additionally or alternatively, in some embodiments, the thickness of the third layer is about 10 μm to about 1000 μm, about 15 μm to about 500 μm. or about 100 μm to about 500 μm. Additionally or alternatively, in some embodiments, the third layer extends beyond each of the first layer, the second layer, and optionally the fourth layer, such that a marginal region of width extends around the wound dressing composition from about 1 mm to about 50 mm, or about 5 mm to about 20 mm. Additionally or alternatively, in some embodiments, the wound-facing side of the extended region of the third layer is coated with a pressure sensitive medical grade adhesive. Additionally or alternatively, in some embodiments, the wound dressing composition is sterile and packaged in a microorganism-impermeabl