US-12616611-B2 - Fluid indicators for wound dressing systems and negative pressure treatment

US12616611B2US 12616611 B2US12616611 B2US 12616611B2US-12616611-B2

Abstract

An indicator, wound dressing system, and negative pressure wound treatment kit configured to provide near real-time, dynamic indication of the fluid status (e.g., fill level, fluid absorbency capacity) of an article is described according to various embodiments. The indicator for detecting a fluid status of a wound dressing may include at least (i) a top side comprising PVDF and one or more markings configured to show fluid levels (ii) a bottom side comprising a pattern-printed adhesive, and (iii) a buffer layer, wherein the buffer layer has a top side comprising a polyurethane film and a bottom side comprising a film retention adhesive. Methods of using the indicator, wound dressing system, and kit are also provided herein.

Inventors

Christopher Brian Locke

Assignees

SOLVENTUM INTELLECTUAL PROPERTIES COMPANY

Dates

Publication Date: 20260505
Application Date: 20210720

Claims (17)

1 . A wound dressing system, comprising: an uncrosslinked silicone polymer adhesive; and an indicator comprising a top side, a bottom side, and a buffer layer, wherein the top side comprises polyvinylidene difluoride (PVDF) and one or more markings configured to show fluid levels, the bottom side comprises a pattern-printed adhesive, and the buffer layer is positioned between the silicone polymer adhesive and the top side of the indicator, wherein the buffer layer further comprises a top side comprising a polyurethane film and a bottom side comprising a film retention adhesive.
2 . The wound dressing system of claim 1 , wherein the indicator further comprises a layer of wicking material.
3 . The wound dressing system of claim 2 , wherein the wicking material does not wick at least one of silicone oil, silicone gel, or a silicone derivative that when contacted with PVDF results in a change of states.
4 . The wound dressing system of claim 2 , wherein the wicking material is configured to wick exudate from a wound and the buffer layer is sized to prevent wicking from the uncrosslinked silicone polymer adhesive.
5 . The wound dressing system of claim 1 , wherein: (i) in a first state, the marking is blocked by the top side PVDF and not visible to a user under ambient or natural light; (ii) wherein in a second state, the marking is visible through the top side under ambient or natural light; and (iii) wherein in a third state, the marking is blocked by the top side and not visible to a user under ambient or natural light, the third state occurring at a point in time subsequent to the second state.
6 . The wound dressing system of claim 5 , wherein the first state is representative of an absence of absorbed wound fluid, the second state is representative of a presence of absorbed wound fluid, and the third state is representative of a reduction by evaporation of the wound fluid present in the second state.
7 . The wound dressing system of claim 1 , wherein the indicator is configured to reversibly undergo a first transition between a first visual configuration and a second visual configuration in response to the indicator being exposed to a first quantity of fluid, and to undergo a second transition between the second visual configuration and the first visual configuration in response to the indicator being exposed to a second quantity of fluid.
8 . The wound dressing system of claim 1 , wherein the indicator further comprises a portion comprising a fluid-impermeable material having a high moisture vapor transmission rate.
9 . The wound dressing system of claim 1 , wherein the buffer layer is about 10 μm in thickness.
10 . The wound dressing system of claim 1 , wherein the pattern-printed adhesive is spaced to create a direct contact area of over 60% between the buffer layer and the indicator and only about 40% coverage of adhesive to retain the buffer layer in place.
11 . The wound dressing system of claim 1 , wherein the buffer layer comprises a spray coating to the top side of the indicator in lieu of the film retention adhesive.
12 . The wound dressing system of claim 1 , wherein the top side of the indicator comprises a polyurethane film extruded onto the PVDF.
13 . The wound dressing system of claim 1 , wherein the PVDF further comprises a hydrophobic coating.
14 . A method of monitoring a fluid status using the wound dressing system of claim 5 , wherein the method comprises: providing the indicator in fluid communication with a wicking layer of the wound dressing system; exposing the wound dressing system to a first amount of fluid during the first state upon an initial application of the wound dressing system to a wound; exposing the wound dressing system to a second amount of fluid during the second state after the initial application of the wound dressing system to the wound; and exposing the wound dressing system to a third amount of fluid during the third state after at least a portion of the second amount of fluid in the second state has been removed or evaporated from the wicking layer of the wound dressing system.
15 . A wound treatment kit, comprising: (i) a negative pressure source; (ii) a wound dressing configured to be attached to a patient, wherein the wound dressing comprises: (a) an uncrosslinked silicone polymer adhesive; and (b) an indicator comprising a top side, a bottom side, and a buffer layer, wherein the top side comprises polyvinylidene difluoride (PVDF) and one or more markings configured to show fluid levels along a lower surface thereof, the bottom side comprises a pattern-printed adhesive, and the buffer layer is positioned between the silicone polymer adhesive and the top side of the indicator layer, wherein the buffer layer further comprises a top side comprising a polyurethane film and a bottom side comprising a film retention adhesive; and (iii) a conduit configured to fluidly couple the negative pressure source to a treatment space defined underneath the wound dressing upon application of the wound dressing to the patient.
16 . The wound treatment kit of claim 15 , wherein the kit further comprises: a manifolding layer configured to distribute negative pressure generated by the negative pressure source to a wound located beneath the wound dressing; and a drape layer configured to secure the manifolding layer relative to the patient; wherein the bottom side of the indicator directly contacts the manifolding layer.
17 . The wound treatment kit of claim 16 , wherein the top side of the indicator directly contacts a lower surface of the drape layer and the bottom side of the indicator directly contacts periwound upon application of the wound dressing to the patient.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Application No. 63/057,383, filed on Jul. 28, 2020, which is incorporated herein by reference in its entirety. FIELD OF THE INVENTION The present disclosure relates generally to an indicator for a wound dressing configured to monitor a fluid level status of the wound dressing and/or the tissue to which the wound dressing is attached. BACKGROUND Existing wound dressing systems are usually configured to transition between a first visual state wherein wound exudate or fluids are not visible to a second state wherein the wound exudate is visible to an attending medical professional or patient. However, these same systems are not capable of reversing from this transition and returning to the first visual state if wound exudate or other fluids evaporate or are removed. The inability to reversibly transition limits the wound dressings to a single use, which can lead to significant waste over the course of a treatment period every time wound fluids collect in the dressing. Developing a system that is able to selectively reverse states upon exposure to wound fluids requires accurate fluid indicators embedded in the dressing so as to allow for visualization of the fluids without removal of the dressing. In certain instances, these indicators may improperly leach silicone oils or gels from adjacent wicking or dressing layers, which can lead to premature transition and incorrectly indicate the presence of wound fluid or excessively hydrated skin. This leaching effect may happen over time, resulting in prematurely switched indicators during shelf-life storage. Thus, there exists a need for a wound fluid indicator and system capable of selectively transitioning upon exposure to wound fluids with high accuracy and sensitivity. SUMMARY The present disclosure overcomes the drawbacks of previously-known systems by providing fluid indicators, wound dressings, wound dressing systems, and methods of use. In one aspect of the present disclosure, an indicator for detecting the fluid status of a wound dressing repair is described. The indicator may comprise, or consist essentially of, or vet further consist of (i) a top side comprising polyvinylidene difluoride (PVDF) and one or more markings configured to show fluid levels, (ii) a bottom side comprising a pattern-printed adhesive; and (iii) a buffer layer, wherein the buffer layer comprises a top side comprising a polyurethane film and a bottom side comprising a film retention adhesive. In a first state, the markings of the indicator may be blocked by the top side comprising PVDF and not visible to a user under ambient or natural light. In a second state, the markings may be visible through the top side under ambient or natural light. In a third state, the markings may again be blocked by the top side and not visible to a user under ambient or natural light, the third state occurring at a point in time subsequent to the second state. In some embodiments, the first state is representative of an absence of absorbed wound fluid, the second state is representative of a presence of absorbed wound fluid, and the third state is representative of a reduction by evaporation of the wound fluid present in the second state. In some embodiments, the top side may be formed from a porous, hydrophilic structure defined by a plurality of fibers. Additionally or alternatively, in certain embodiments, in the first state, the fibers have a first refractive index and in the second state the fibers have a second refractive index that is greater than the first refractive index. In some embodiments, the indicator may be exposed to a fluid in the second state, the material from which the fibers are formed being selected such that, when exposed to the fluid, the second refractive index of the fibers is substantially the same as the refractive index of the fluid. In accordance with another aspect of the disclosure, a wound dressing system is described. The wound dressing system may comprise, or consist essentially of, or vet further consist of: (i) an uncrosslinked silicone polymer adhesive; (ii) an indicator comprising a top side, a bottom side, and a buffer layer, wherein the top side comprises polyvinylidene difluoride (PVDF) and one or more markings configured to show fluid levels along a lower surface thereof, the bottom side comprises a pattern-printed adhesive; and the buffer layer is positioned between the silicone polymer adhesive and the indicator layer, wherein the buffer layer comprises a top side comprising a polyurethane film and a bottom side comprising a film retention adhesive. In the wound dressing system, the indicator further may include a layer of wicking material. Additionally or alternatively, the wicking material may be designed to not wick at least one of silicone oil, silicone gel, or a silicone derivative that when contacted with PVDF results in a change of states. In certa