The present disclosure relates generally to the field of treating wounds (e.g., burns, lacerations, surgical incisions, sores, ulcers, damaged tissue, nerve damage, etc.) and more particularly to managing excess moisture during the treatment of a wound.
During the treatment of a wound, the wound and surrounding skin (periwound) may be isolated from the ambient environment by a wound dressing to stimulate quicker healing. The wound dressing is typically defined by a fluid absorbency capacity that remains unchanged over time. Thus, once the fluid capacity of the wound dressing has been reached, the wound dressing will be incapable of absorbing or holding any additional fluid. In such situations, the exposure of the wound dressing to any additional fluid may put the wound dressing at a risk of leaking, swelling, and becoming detached.
Additionally, excess moisture within the wound dressing may decrease the effectiveness of wound treatment and lead to patient discomfort. In particular, excess moisture within a wound dressing may act as a thermal insulator, which induces sweating and patient discomfort. Moreover, sustained exposure to moisture increases the risk of tissue maceration-particularly when the wound dressing is applied over large areas of periwound. To avoid the problems associated with excess moisture, users are often required to increase the frequency with which wound dressings are changed during the treatment of the wound.
It would therefore be desirable to provide a wound treatment system configured to accelerate the evaporation of fluid from a wound dressing.
In one implementation of the present disclosure, a wound treatment system includes a wound dressing and a moisture management system. The wound dressing includes a moisture vapor permeable backing layer configured to be secured to a patient. The backing layer includes a lower, wound-facing surface and an upper surface. The moisture management system includes a film layer and a spacer assembly configured to be supported atop the upper surface of the backing layer to define a flow path between the backing layer and the film layer.
According to some embodiments, the moisture management system further includes an air displacement device sealingly coupled to an opening extending through the film layer and configured to cause air to flow through the flow path. The moisture management system further includes one or more outlets that provide fluid communication between the flow path and an ambient environment. The one or more outlets may be defined by apertures formed in and extending through the film layer.
An outer perimeter of the film layer may be configured to be continuously sealed to the upper surface of the backing layer. The one or more outlets may comprise channels defined between the upper surface of the backing layer and a lower surface of the film layer at locations around the perimeter of the film layer. According to some embodiments, the air displacement device is further sealingly coupled to an opening extending through the backing layer of the wound dressing. The operation of the air displacement device is configured to evacuate air from a space defined between a wound to which the wound dressing is attached and the lower surface of the backing layer.
In one implementation of the present disclosure, a moisture management system for a wound dressing includes a film layer, a spacer assembly and an air displacement device. The spacer assembly includes an upper end extending from a lower surface of the film layer, a lower end, a first surface defined between the upper end and the lower end and a second surface defined between the upper end and the lower end. The second surface is located opposite the first surface such that a channel is defined between a lower surface of the film layer, the first surface and the second surface. The air displacement device is sealingly engaged with an opening formed in and extending through the film layer and is configured to cause air to flow through the flow path. The air displacement device may be entirely supported atop an upper surface of the film layer. The air displacement device may include a connector structure sealingly attached around the opening in the film layer that is optionally configured to be fluidly connected to a pump located remotely from the film layer by a conduit.
In some embodiments, the spacer assembly and film layer define a monolithic structure. For example, the spacer assembly includes a plurality of projections defined by portions of the film layer that have been embossed to extend downwards relative to non-embossed portions of the lower surface of the film layer. In other embodiments in which the spacer assembly and film layer define a monolithic structure, the lower surface of the film layer includes a textured surface defined by a plurality of peaks and valleys. The spacer assembly is defined by the peaks of the textured lower surface of the film layer.
According to some embodiments, the spacer assembly is defined by a plurality of wall structures attached to and extending downwards from the lower surface of the film layer. In other embodiments, the spacer assembly is defined by a plurality of adhesive dots formed along the lower surface of the film layer. In yet other embodiments, the spacer assembly is defined by a porous body configured to be attached along an upper surface to the lower surface of the film layer. The upper surface of the porous body includes a plurality of openings defined therein. The porous body may include a foam layer. The porous body may alternatively include a scaffold structure defined by a plurality of strut elements.
In one implementation of the present disclosure, a method of managing moisture of a wound dressing, includes attaching a moisture management system to an upper surface of a backing layer of a wound dressing. The moisture management system includes a film layer and a spacer assembly configured to be supported atop the upper surface of the backing layer to define a flow path between the backing layer and the film layer. The air displacement device is sealingly attached around an opening formed in the film layer. The air displacement device is operated to cause a displacement of air within the flow path to increase evaporation of liquid from the wound dressing. The moisture management system is optionally attached to the upper surface of the wound dressing prior to the wound dressing being attached to a patient.
The air displacement device may optionally also be fluidly coupled to a space defined underneath the wound dressing, and operated to evacuate air from the space defined underneath the wound dressing. According to some embodiments, the displacement of air within the flow path of the spacer assembly is caused by a waste positive pressure airflow generated by the air displacement device during operation of the air displacement device to evacuate air from the space underneath the wound dressing. In some embodiments, the displacement of air within the flow path of the spacer assembly is caused by a negative pressure airflow generated by the air displacement device.
A moisture indicating element is optionally provided beneath the backing layer of the wound dressing. The moisture indicating element is configured to transition between a first state in which a marking formed on a lower layer of the moisture indicating element is visible, a second state in which the marking is not visible, and a third state in which the moisture indicating element is visible. An optional controller is configured to operate the air displacement device to cause a displacement of air within the flow path while the moisture indicating element is in the first state, stop operation of the air displacement device in response to a transition of the moisture indicating element from the first state to the second state, and initiate operation of the air displacement device in response to a transition of the moisture indicating element from the second state to the third state.
In one implementation, a wound treatment system includes a wound dressing and a moisture management system. The wound dressing includes a moisture vapor permeable backing layer configured to be secured to a patient and a manifold layer configured to allow fluid to be transmitted to the wound. The moisture management system is supported atop an upper surface of the backing layer. The moisture management system includes an opening configured to fluidly and sealingly couple an air displacement device to a flow path defined between the moisture management system and the upper surface of the backing layer. The flow path is fluidly isolated from a treatment space defined underneath the backing layer.
In some embodiments, the moisture management system includes a film layer and a spacer structure. The spacer structure extends upwards from the upper surface of the backing layer and vertically offsets the film layer relative to the backing layer. In some embodiments, the manifold layer includes an open-cell foam.
The wound dressing further optionally includes a non-porous wound interface layer, such as, for example, a polyurethane film. In some embodiments, the film includes a plurality of perforations extending therethrough. The perforations optionally defined elastic passages configured to open in response to a pressure gradient across the film. In the absence of a pressure gradient across the film, the perforations are unstrained and configured to restrict fluid flow therethrough.
In some embodiments, a flow path is not defined along at least a portion of the backing layer that overlays the manifold layer. For example, the flow path extends only along an outer periphery of the backing layer which extends radially outwards relative to an outer periphery of the manifold layer. In some embodiments, one or more moisture indicators are located along the outer periphery of the backing layer.
In one implementation, a wound treatment system includes a wound dressing and a moisture management system. The wound dressing includes a moisture vapor permeable backing layer configured to be secured to a patient and an absorbent layer configured to store fluid exuded from a wound. The moisture management system is supported atop an upper surface of the backing layer. The moisture management system includes an opening configured to fluidly and sealingly couple an air displacement device to a flow path defined between the moisture management system and the upper surface of the backing layer. The flow path is fluidly isolated from a treatment space defined underneath the backing layer.
In some embodiments, the moisture management system includes a film layer and a spacer structure. The spacer structure extends upwards from the upper surface of the backing layer and vertically offsets the film layer relative to the backing layer. In some embodiments, the absorbent layer includes a superabsorbent material. The superabsorbent material is optionally contained within a pouch formed from a non-woven material.
The wound dressing further optionally includes a non-porous wound interface layer, such as, for example, a polyurethane film. In some embodiments, the film includes a plurality of perforations extending therethrough. The perforations optionally defined elastic passages configured to open in response to a pressure gradient across the film. In the absence of a pressure gradient across the film, the perforations are unstrained and configured to restrict fluid flow therethrough.
In some embodiments, one or more moisture indicators are located along the absorbent layer. The wound treatment system optionally includes a controller configured to operate the air displacement device to generate a flow of air through the flow path in response to at least one or the one or more moisture indicators detecting a predetermined fluid level in the absorbent layer.
Referring to the FIGURES, a wound treatment system configured to facilitate the removal of excess moisture from a wound site is shown according to various exemplary embodiments. As illustrated in
Referring to
The wound dressing 200 may be defined by a variety of different types of wound dressings. The wound dressing 200 may also be configured to treat a variety of different types of wounds, and for use in a variety of different types of wound treatments. The wound dressing 200 may be used as a stand-alone wound treatment, or may be a component of an additional wound therapy system with which the wound treatment system 100 is used, such as, e.g., a negative pressure wound treatment (“NPWT”) system, an instillation therapy system, etc.
The wound dressing 200 includes a drape layer 202, and optionally any number and combination of additional layers. The number and selection of the additional dressing layers forming the wound dressing 200 may vary depending on a variety of factors, including, but not limited to: the type of wound being treated, the location of the wound being treated, the type of treatment being provided to the wound, the type of optional additional wound therapy system with which the wound treatment system 100 is used, etc. Non-limiting examples of additional dressing layers which may form a part of the wound dressing 200 include, e.g., an absorbent layer 204, an interface layer 206, a manifold layer 208, a wicking laver, etc.
A. Drape Layer
The drape layer 202 of the wound dressing 200 supports the additional layers of the wound dressing 200 (e.g., the absorbent layer 204, the interface layer 206, the manifold layer 208, etc.) at the wound site. As described in more detail below, an upper surface 203 of the drape layer 202 delimits a lower portion of the flow path 340 of the wound treatment system 100.
As shown in
The drape layer 202 may be formed from any number of different types of materials that are substantially impermeable to liquid and substantially permeable to moisture vapor. In other words, the drape layer 202 is permeable to water vapor, but not permeable to liquid water or wound exudate. This increases the total fluid handling capacity of the wound dressing 200 while promoting a moist wound environment. In some embodiments, the drape layer 202 is also impermeable to bacteria and other microorganisms. A suitable material for the drape layer 202 is a high moisture vapor transmission rate (“MVTR”) material. As described in detail below, the wound treatment system 100 exploits the high MVTR of the drape layer 202 to manage fluids within the wound dressing 200. In some embodiments, the drape layer 202 is a thin layer of polyurethane film. One example of a suitable material for the drape layer 202 is the polyurethane film known as ESTANE 5714F. Other suitable polymers for forming the drape layer 202 include poly alkoxyalkyl acrylates and methacrylates, such as those described in Great Britain Patent Application No. 1280631A filed Nov. 22, 2002, the entire disclosure of which is incorporated by reference herein.
B. Absorbent Layer
As illustrated by the wound treatment system 100 embodiment of
C. Manifold Layer
As illustrated by the wound treatment system 100 embodiment of
D. Interface Layer
In various embodiments, the interface layer 206 is configured to reduce potential adherence of the wound dressing 200 to the wound and/or to prevent ingrowth of skin to the wound dressing 200. The interface layer 206 may be defined by a nonporous material comprising a plurality of perforations (fenestrations, holes, airways, windows, slits, etc.) extending therethrough that allow air and fluid to pass between the wound and the other layers of the wound dressing 200. In some embodiments, the interface layer 206 is made of a hydrophobic material such as polyethylene (PE) or other hydrophobic polymers.
According to some embodiments, the interface layer 206 may comprise a liquid-impermeable, elastomeric film having a plurality of bi-directional, pressure-responsive perforations formed therethrough. The interface layer 206 is optionally dimensioned such that an outer perimeter of the interface layer 206 is coextensive with, or slightly greater than the manifold layer 208 and/or absorbent layer 204 (e.g., the area of the interface layer 206 is between approximately 5% and 10% greater than the area of the manifold layer 208 and/or absorbent layer 204). The fluid restrictions define elastic passages that can expand (e.g. open) in response to a pressure gradient to allow flow therethrough. In the absence of a pressure gradient, the passages may be sufficiently small to form a seal or fluid restriction, thereby reducing or preventing liquid flow through the interface layer 206. Non-limiting examples of various materials from which the film defining the interface layer 206 in such embodiments may be formed include polyurethane, polyethylene, acrylics, polyolefin (such as cyclic olefin copolymers), polyacetates, polyamides, polyesters, copolvesters, PEBAX block copolymers, thermoplastic elastomers, thermoplastic vulcanizates, polyethers, polyvinyl alcohols, polypropylene, polymethylpentene, polycarbonate, styreneics, silicones, fluoropolymers, acetates, etc. In some such embodiments, the film may have thickness between approximately 50 microns and approximately 250 microns, and more specifically between approximately 100 microns and approximately 200 microns.
In some embodiments, the perforations comprise linear slots having a length less than approximately 4 millimeters (e.g. 3 millimeters), with adjacent slots spaced approximately 3 millimeters from one another. In other embodiments, the perforations may be defined by other configurations (e.g. holes) that are arranged in generally linear clusters having a length less than approximately 4 millimeters or less (e.g. 3 millimeters), with adjacent clusters optionally spaced approximately 3 millimeters from one another. In yet other embodiments, the perforations may be defined by any other variety of arrangements and dimensions.
The moisture management system 300 operates to control moisture levels in a treatment space defined underneath the wound dressing 200 of the wound treatment system 100 by forcing airflow along an upper, outer surface of the wound dressing 200. Although the management of moisture levels in the treatment space may, in some embodiments, optionally be supplemented via the direct removal of fluids from the treatment space using a source of forced negative airflow (e.g. a pump) fluidly coupled to the treatment space—the management of moisture levels using the moisture management system 300 of the wound treatment system 100 described herein does not itself require fluid communication with the treatment space beneath the wound dressing 200. Rather, the forced airflow along the wound dressing 200 generated during operation of the moisture management system 300 indirectly removes moisture from the treatment space (i.e. removes moisture from the treatment space even in the absence of any fluid communication with the treatment space) by accelerating the diffusion and evaporation of fluid within the treatment space through the high MVTR drape layer 202 of the wound dressing 200.
As shown in
Some or all of the components of the moisture management system 300 may be single use, or may optionally be configured to be re-used with different wound dressings 200. In some embodiments, the moisture management system 300 is configured for stand-alone treatment of a wound (i.e., wherein the wound treatment system 100 operates independent of any other wound therapy system or device). In other embodiments, the moisture management system 300 may be configured for use alongside other wound therapy systems, such as, e.g., an NPWT system.
A. Film Layer
Referring to
The film layer 310 optionally supports a connector 360 (e.g., a port, a SENSAT. R.A.C.™ connection pad marketed by ACELITY™, etc.) via which the air displacement device 350 is coupled to the flow path 340. The connector 360 may indirectly couple the air displacement device 350 to the flow path 340 via a conduit 354 that is attached to and extends between the connector 360 and a remotely located air displacement device 350. Alternatively, in some embodiments, the air displacement device 350 and the connector 360 are components of an integrated module 400 (described in more detail below) that is supported relative to the film layer 310 (see, e.g.,
In some embodiments, the opening 312 extends through a substantially central location of the film layer 310, so as to facilitate a generally uniform distribution of air flow along the upper surface of the wound dressing 200. In other embodiments, the fluid opening 312 (and corresponding connection between the air displacement device 350 and the flow path 340) may be arranged at other locations relative to the film layer 310 and/or wound dressing 200. For example, when treating a wound that exudes fluids at varying rates at different locations, the opening 312 is optionally formed at a location along the film layer 310 that will overlie a region of the wound that exudes fluid at a high rate. As another example, in embodiments in which the wound dressing 200 is attached at a location on a patient where gravity will result in the pooling of exudate at a lower portion of the wound dressing 200 (e.g. when the wound dressing 200 is attached to a leg, torso, upper arm, etc.), the fluid opening 312 may be formed at a location adjacent to a lower perimeter of the film layer 310.
The dimensions of the film layer 310 may be smaller, the same as, or larger than the dimensions of the wound dressing 200 of the wound treatment system 100. The dimensions of the film layer 310 relative to the wound dressing 200 may be selected based on an intended treatment protocol. For example, given the detrimental effect moisture may have on a periwound, in various embodiments the film layer 310 is sized to be coextensive with, or extend beyond, the outer perimeter of the wound dressing 200 to which the moisture management system 300 is attached, such as, e.g., representatively illustrated in
In some embodiments, the film layer 310 is attached to an underlying surface (e.g. an upper surface of the wound dressing 200, the skin of a patient, etc.) in situ during the attachment of the wound treatment system 100 to the patient. In such embodiments, adhesive is optionally provided along portions, or the entirety, of the perimeter of the lower surface 311 of the film layer 310 to facilitate the attachment of the film layer 310 to the underlying surface. Alternatively, the film layer 310, spacer structure 320 and drape layer 202 are optionally provided as a single, integrated assembly, in which the perimeter of the film layer 310 is preattached (via, e.g., adhesive, welding, etc.) to the drape layer 202.
B. Vents
As noted above, the film layer 310 includes and/or defines one or more vents 314 via which air is forced out from or into the flow path 340 during operation of the air displacement device 350. In some embodiments, such as, e.g., shown in
As shown in
In embodiments in which the wound treatment system 100 is configured to be operated in a negative pressure mode, valves and/or filters are optionally located within some or all of the vents 314. During operation of the wound treatment system 100 in the negative pressure mode, the optional valves (e.g., slit valves 318) are configured to provide control over the rate of ambient air flow into the flow path 340, while the optional filters are configured to prevent microorganisms or other harmful particles from entering the flow path 340 (and air displacement device 350).
C. Spacer Structure
The spacer structure 320 (e.g. spacer assembly, support structure) of the moisture management system 300 vertically offsets (e.g., spaces apart, separates, elevates, etc.) the lower surface 311 of the film layer 310 from the upper surface 203 of the drape layer 202 upon assembly of the wound treatment system 100. The space (e.g., void, air gap, etc.) defined between the lower surface 311 of the film layer 310 and the upper surface 203 of the drape layer 202 as a result of this vertical offset defines a portion of the flow path 340 of the wound treatment system 100.
The spacer structure 320 includes one or more flow elements 322 each having an outer surface that extends between a first end 321 (e.g., an upper end) and a second end 323 (e.g., a lower end). Upon assembly of the wound treatment system 100, the spacer structure 320 is arranged relative to the wound dressing 200 and film layer 310 so that the first ends 321 of the flow elements 322 are located adjacent and extend downwards relative to the lower surface 311 of the film layer 310. The second ends 323 of the flow elements 322 are located adjacent to and extend upwards relative to the upper surface 203 of the drape layer 202.
To facilitate assembly of the wound treatment system 100, the second ends 323 of the flow elements 322 are optionally coated with an adhesive via which the spacer structure 320 can be attached relative to the upper surface 203 of the drape layer 202. In embodiments in which the spacer structure 320 and film layer 310 are not monolithically, or otherwise integrally formed, the upper ends 321 of the spacer structure 320 may also optionally be coated with an adhesive via which the spacer structure 320 can be attached relative to the lower surface 311 of the film layer 310. In yet other embodiments, the drape layer 202, spacer structure 320 and film layer 310 are provided a single, integrated structure, such that assembly of the wound treatment system 100 in situ requires no more effort than would typically be required to assemble a wound dressing comprising a separately attachable backing layer (e.g. a drape layer).
As illustrated by the embodiments of
To facilitate the assembly of the wound treatment system 100, in other embodiments the spacer structure 320 and film layer 310 are optionally provided as a single, integral one-piece structure. In some such embodiments, the spacer structure 320 is monolithically formed with the film laver 310, with the flow elements 322 including structures that are defined by the lower surface 311 of the film layer 310. In other such embodiments, the flow elements 322 defining the spacer structure 320 include discrete structures that are attached to the lower surface 311 of the film layer 310.
Illustrated in
As illustrated by the embodiment of
Exemplary embodiments of spacer structures 320 that are monolithically formed with the film layer 310 are shown in
Turning to
According to some embodiments, instead of the spacer structure 320 and film layer 310 being provided as an integral, one-piece assembly, the spacer structure 320 and drape layer 202 may alternatively be provided as an integral, one-piece assembly.
Shown in
Referring to
As also illustrated by
Alternatively, it may instead be desired to direct dry air along only specific target locations along the wound dressing 200, such as, e.g., to portions of the flow path 340 that overlie the periwound, or which overlie highly exuding regions of the wound. Accordingly, in some embodiments, the shape, size, and arrangement of flow elements 322 may be selected to define one or more enclosed flow channels that are discrete and fluidly isolated from other portions of the flow path 340 (such as, e.g., representatively illustrated by the embodiments of
In yet other embodiments, the arrangement of flow elements 322 in a non-uniform distribution, and/or the selection of flow elements 322 having varying sizes may be used to accelerate the rate of moisture removal at the target locations. For example, the arrangement of flow elements 322 in a greater density and/or the arrangement of flow elements 322 having larger dimensioned second ends 323 at locations relative to portions of the wound dressing 200 that do not correspond to target locations minimizes the degree to which air flowing through the flow path 340 passes along the upper surface 203 of the drape layer 202 at such non-target locations. Resulting, less moisture is acquired by the air flowing through the flow path 340 prior to the air reaching a target location (e.g. a portion of the flow path 340 overlaying the periwound). Because drier air has a greater capacity to lift moisture from the upper surface 203 of the drape layer 202, the decreased moisture level of the air flowing through the flow path 340 along the target locations increases the rate at which moisture may be removed from the target locations. In other embodiments, a similar effect of delivering drier air flow to desired target locations may also be accomplished using an optional blocking structure (e.g. a thicker layer of adhesive, an intermediate layer of material, etc.) that is arranged between the spacer structure 320 and drape layer 202 along the portions of the wound dressing 200 that do not correspond to the target locations.
D. Air Displacement Device
The air displacement device 350 may include any number of different air-moving devices (e.g., manual or automatic pump, blower, bellows, etc.). As shown in
Operation of the air displacement device 350 is configured to generate a flow of air through the flow path 340 of the wound treatment system 100. As illustrated in
In embodiments in which the wound treatment system 100 is used alongside an additional wound therapy system incorporating a pump or other air moving device, the air displacement device 350 may be provided in addition to the pump of the additional wound treatment system (e.g., a NPWT system), such that such that the wound treatment system 100 is capable of being operated independently and separately from the NPWT system (or other wound treatment system).
Alternatively, in other embodiments, the pump of the NPWT system (or other additional wound therapy system with which the wound treatment system 100 is used) defines the air displacement device 350. As illustrated in
The shared pump that defines each of the NPWT system (or other additional wound therapy system with which the wound treatment system 100 is used) and the air displacement device 350 may alternate between being operated to provide treatment using the NPWT system and providing treatment using the wound treatment system 100. In such embodiments, the connector 360 optionally includes one or more valves via which the shared pump is selectively fluidly coupled to either the NPWT conduit 361 or the moisture management conduit 363 based on the desired treatment. For example, the connector 360 includes an optional proportional leak valve configured to fluidly couple the pump to moisture management conduit 363 while fluidly isolating the NPWT conduit 361 during operation of the shared pump to generate pressures in excess of a predetermined threshold (e.g. at negative pressures above 150 mmHg). During operation of the shared pump at pressures below the predetermined threshold, the valve is configured to fluidly couple the pump to the NPWT conduit 361, while fluidly isolating the moisture management conduit 363.
During other operations of the wound treatment system 100 and NPWT system (or other additional wound therapy system with which the wound treatment system 100 is used), the shared pump that defines the air displacement device 350 is operated to simultaneously provide treatment using each treatment system. As illustrated by
As shown in
E. Module
As noted above, and representatively illustrated by the wound treatment system 100 embodiment of
The module 400 optionally includes an engagement structure configured allow the module 400 to be sealingly secured around (e.g. adjacent to, surrounding, etc.) an outer periphery of the opening 312 in the film layer 310 via an engagement to an optional connector 360 supported relative to the film layer 310. In other embodiments, the module 400 may also be secured directly to the film layer 310 using adhesive, welding, etc. In embodiments in which the module 400 is intended to be reused with additional wound dressings 200, bacterial and/or hydrophobic filters 380 are optionally provided between the opening 312 in the film layer 310 and an inlet of the module 400. For example, filters 380 may be attached to any one or more of the opening 312 in the film layer 310, the connector 360, and the engagement structure of the module 400 to prevent fluid and/or bacterial ingress and contamination of the module 400 during use of the wound treatment system 100 and/or during attachment or removal of the module 400 to or from wound dressing 200.
Various operations of the wound treatment system 100 may be controlled by an optional controller 500 (shown, e.g., in
The controller 500 may be configured to operate the various components of the wound treatment system 100 (e.g. the air displacement device 350, valves, etc.) based on a variety of different inputs received from any number of different sources. For example, in some embodiments, the controller 500 may operate the wound treatment system 100 based on inputs received from a user. In other embodiments, the controller 500 may be configured to operate the wound treatment system 100 in accordance to one or more preprogrammed modes stored in a memory of the controller 500. For example, the controller 500 may operate the wound treatment system 100 in an alternating pressure mode, in which operation of the air displacement device 350 is periodically varied between operation in the positive pressure mode, and operation in the negative pressure mode. Such periodic alternation between positive and negative air flow may advantageously be used disrupt regions of dense flow within the treatment space underneath the wound dressing 200 and to allow moisture to be removed more uniformly from the wound.
In yet other embodiments, the controller 500 is configured to operate the wound treatment system 100 responsive to readings or measurement obtained from one or more sensors (e.g. moisture sensor, humidity sensor, pressure sensor, etc.) incorporated into the wound treatment system 100. According to an exemplary embodiment, the wound treatment system 100 includes a moisture level sensor assembly comprising one or more moisture indicators and an optical reader configured to detect changes in the indicators. Given that the fluid capacity of and/or fluid levels within the wound dressing 200 may vary over time, the indicators are advantageously selected to be capable of providing a dynamic, two-way (i.e. reversible), near real-time indication as to both increases and decreases in moisture levels within the wound dressing 200 over the course of use of the wound treatment system 100.
One non-limiting example of such a reversible, dynamic indicator that may be used in the wound treatment system 100 is described in more detail in co-pending application U.S. 62/784,187, filed Dec. 21, 2018 and titled “FLUID STATUS INDICATOR FOR A WOUND DRESSING,” the entirety of which is incorporated herein by reference. In addition to providing a dynamic representation of moisture levels in the treatment space underneath the wound dressing 200, the indicators described in the above referenced co-pending application also advantageously are positionable entirely underneath the wound dressing 200 (i.e. do not extend through the drape layer 202). Such an incorporation of indicators into the wound treatment system 100 allows the wound dressing 200 to remain integral and sealed, and thus advantageously minimizes the risk of exudates, or other fluids or substances from the treatment space underneath the wound dressing 200, contaminating the components of the optionally included module 400.
The moisture indicators are incorporated into (i.e. positioned in direct contact with) one or both of the drape layer 202 and an additional dressing layer (e.g., an absorbent layer 204, a manifold layer 208, etc.), so as to be capable of dynamically responding to changes in moisture levels within the wound dressing 200 (e.g. changes in the fluid capacity of the absorbent layer 204, moisture levels at a portions of the drape layer 202 overlaying the periwound, etc.). The indicators are advantageously positioned directly below the drape layer 202 to facilitate the ability of the optical reader to detect changes in the visual appearance of the indicators through the drape layer 202. A fusible fiber (or other attachment mechanism) optionally secures the indicators relative to the wound dressing 200 to ensure contact of the indicators with the absorbent layer 204 and/or to ensure that the indicators are aligned relative to the module 400 such that visual transformations of the indicators are capable of being detected by the optical reader. The optical reader is optionally incorporated into the module 400, or is otherwise positionable relative to the upper surface of the wound treatment system 100.
During some uses of the wound treatment system 100, the controller 500 is optionally configured to operate the air displacement device 350 in a manner configured to minimize power consumption. For example, during the operation of the wound treatment system 100 to prevent moisture levels from exceeding a static fluid capacity of a wound dressing 200, the controller 500 may optionally be configured to initiate operation of the air displacement 350 to generate airflow through the flow path 340 only in response to the detection of a visual transition of an indicator indicative of the moisture level in the treatment space underneath the wound dressing 200 being equal to, or exceeding, a predetermined upper threshold moisture level. Additionally, or alternatively, in some embodiments the controller 500 may optionally be configured to initiate operation of the air displacement 350 to generate airflow through the flow path 340 in response to the detection of a visual transition of an indicator indicative of the moisture level at the periwound being equal to, or exceeding, a predetermined upper threshold moisture level.
Upon detecting (e.g. via a visual transition of the indicators) that the moisture level has decreased to a level equal to or below an intermediate moisture level, the controller 500 is optionally configured to reduce the speed at which the air displacement device 350 is operated. Once the moisture level within the treatment space has reached a level equal to or below a predetermined lower threshold (e.g. between approximately 40% and less than approximately 50% of the fluid capacity of the wound dressing 200), the controller 500 ceases operation of the air displacement device 350 to save power until such a time when the moisture level in the treatment space (e.g. a moisture level of an optional absorbent layer 204, a moisture level at the periwound, etc.) is detected to again be equal to or greater than the upper predetermined threshold. Such selective operation of the air displacement device 350 may continue one or more times during the operation of the wound treatment system 100.
In some embodiments, the controller 500 may be configured to continuously receive readings and measurements from one or more sensors (e.g., from a moisture level sensor assembly). Alternatively—to further conserve power—the controller 500 may instead be configured to selectively obtain sensor readings only at predetermined intervals (e.g., every 3-5 minutes). In some such embodiments, the predetermined interval at which the sensor readings are obtained may vary in response to the detection of various threshold sensor readings. For example, the controller 500 may be configured to obtain moisture level readings at a more frequent interval following the detection (using, e.g., the moisture level sensor assembly) that a moisture level underneath the wound dressing 200 is equal to, or exceeds, an upper moisture level threshold.
In various embodiments, the air displacement device 350 optionally comprises a plurality of independently operable air displacement devices 350 that are fluidly coupled at various locations to the flow path 340 around (e.g. adjacent to, surrounding, etc.) the outer peripheries of various openings 312 in the film layer 310. In such embodiments, the operation of some or all of the air displacement devices 350 is optionally independently controllable, allowing moisture levels to be managed as needed at specific target areas along the wound dressing 200. In some embodiments, each individual air displacement device 350 is individually controllable responsive to a moisture level reading (or other sensed condition) obtained from a moisture indicator (or other sensor) positioned at a location relative to the wound that corresponds to the location at which the respective air displacement device 350 is positioned. In addition to allowing airflow to be directed to specific desired target locations, such selective activation of only those air displacement devices 350 that are needed to provide the desired delivery of airflow also further assists in decreasing the power consumption of the wound treatment system 100.
The construction and arrangement of the systems and methods as shown in the various exemplary embodiments are illustrative only. Although only a few embodiments have been described in detail in this disclosure, many modifications are possible (e.g., variations in sizes, dimensions, structures, shapes and proportions of the various elements, values of parameters, mounting arrangements, use of materials, colors, orientations, etc.). For example, the position of elements can be reversed or otherwise varied and the nature or number of discrete elements or positions can be altered or varied. Accordingly, all such modifications are intended to be included within the scope of the present disclosure. The order or sequence of any process or method steps can be varied or re-sequenced according to alternative embodiments. Other substitutions, modifications, changes, and omissions can be made in the design, operating conditions and arrangement of the exemplary embodiments without departing from the scope of the present disclosure.
As utilized herein, the terms “approximately,” “about,” “substantially”, and similar terms are intended to have a broad meaning in harmony with the common and accepted usage by those of ordinary skill in the art to which the subject matter of this disclosure pertains. It should be understood by those of skill in the art who review this disclosure that these terms are intended to allow a description of certain features described and claimed without restricting the scope of these features to the precise numerical ranges provided. Accordingly, these terms should be interpreted as indicating that insubstantial or inconsequential modifications or alterations of the subject matter described and claimed are considered to be within the scope of the disclosure as recited in the appended claims.
This application claims the benefit of priority to U.S. Provisional Application No. 62/890,316, filed on Aug. 22, 2019, which is incorporated herein by reference in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/IB2020/057196 | 7/30/2020 | WO |
Number | Date | Country | |
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62890316 | Aug 2019 | US |