The present disclosure relates generally to wound dressings. Wound dressings can provide a sterile interface to guard a patient's wound from contamination during the healing process. Dressings may also absorb wound fluid and/or increase the rate that wound fluid is removed from a wound bed. During the healing process, wound fluid can build up within the dressing and/or within an absorbent article therein. It would be desirable to provide a single wound dressing having an optional wound status indicator adaptable for use in applications where status indication is desired and where status indication may not be deemed necessary.
One implementation of the present disclosure is a dressing for a wound, according to some embodiments. In some embodiments, the dressing includes a drape, an absorbent core, and a wicking member. The drape can be configured to sealingly couple with a patient's skin surrounding the wound. In some embodiments, the drape encloses an inner volume of the dressing. In some embodiments, the absorbent core layer is positioned within the inner volume of the dressing. In some embodiments, the wicking member is positioned within the inner volume. In some embodiments, the wicking member extends from an underside of the absorbent core layer to the drape. In some embodiments, the indicator is configured to fluidly couple with the wicking member through the drape and receive fluid from the wicking member. In some embodiments, the indicator is configured to provide a visual wound status indication in response to receiving fluid from the wound through the wicking member.
Another implementation of the present disclosure is a convertible dressing for a wound. In some embodiments, the convertible dressing includes an absorbent core, a wicking member, and a drape. The wicking member may extend along an exterior surface of the absorbent core. The drape can be configured to extend over the absorbent core and the wicking member. The drape can include a removable portion configured to expose or produce an aperture in the drape. The aperture may be aligned with the wicking member.
Another implementation of the present disclosure is a method of providing a dressing with a wound status indication. The method can include providing a dressing having a wound drape that seals with a user's skin surrounding a wound. The dressing may include an absorbent core and a wicking member within the wound drape. The wicking member can extend between an underside of the absorbent core and the wound drape. The method can include providing an opening in the wound drape aligned with the wicking member. The method can also include providing a visual indicator at the opening. The visual indicator is configured to provide a visual wound status indication in response to receiving fluid from the wicking member.
Another implementation of the present disclosure is a kit for a wound dressing with optional status indication. The kit may include a sealed package, a wound dressing, and one or more wound status indicators. The sealed package may have a sterilized interior containing at least the wound dressing and the one or more wound status indicators. The wound dressing may include a drape, an absorbent core, and a wicking layer. The drape may include an opening and a removable cover on the opening. The one or more wound status indicators may be configured to be optionally placed over the opening in communication with the wicking layer after removal of the removable cover.
Those skilled in the art will appreciate that the summary is illustrative only and is not intended to be in any way limiting. Other aspects, inventive features, and advantages of the devices and/or processes described herein, as defined solely by the claims, will become apparent in the detailed description set forth herein and taken in conjunction with the accompanying drawings.
Referring generally to the FIGURES, a wound dressing includes a drape layer, an absorbent core, and a wicking structure. The drape layer may be configured to sealingly couple with patient's skin surrounding a wound to define an inner or internal volume of the wound dressing. In some embodiments, the drape layer includes an adhesive that is coated along at least a portion of a periphery of an interior or wound-facing surface of the drape layer.
The absorbent core and the wicking structure are positioned within the drape layer. In some embodiments, the absorbent core and the wicking structure are positioned between the patient's skin/wound and the interior surface of the drape layer. The absorbent core may abut, directly engage, contact, be placed over, be positioned over, etc., the patient's wound. The wicking structure may be a strip or an elongated thin member that extends between the drape layer and the absorbent core. The wicking structure may extend laterally along an outwards or exterior surface of the absorbent core. In some embodiments, the wicking structure extends at least partially underneath the absorbent core or between the absorbent core and the patient's skin/wound. The wicking structure may fluidly couple at one end with the patient's wound so that the wicking structure absorbs fluid exuded by the wound. The wicking structure can extend to an opposite side of the absorbent structure between the drape layer and the absorbent core.
In some embodiments, the drape layer includes an opening, a hole, an aperture, a port, a window, etc., that extends through an outwards side of the drape layer. The opening may be aligned with the wicking structure to facilitate a flow path from the wound, along the wicking structure, and out of the opening. In some embodiments, the opening is covered with a cover layer that can be removed by a caregiver to expose the opening. The caregiver may then apply an indicator assembly to the drape layer over the opening so that the indicator assembly receives fluid from the wound through the wicking structure. The indicator can include a portion that is responsive to fluid to provide a visual indication to the caregiver regarding a healing progression of the wound and/or to provide a visual indication of whether or not the wound is infected.
Referring particularly to
Wound drape 104 can be a polyurethane (PU) film layer that extends over a patient's wound 122 (shown in
In some embodiments, absorbent core 106 and wicking member 108 are positioned within inner volume 126 of dressing 100. Absorbent core 106 can be configured to directly engage, contact, abut, etc., the patient's wound 122 to facilitate absorbing or removing fluid (e.g., wound fluid, wound exudate, etc.) from the patient's wound 122. Absorbent core 106 may be entirely positioned within inner volume 126. Inner volume 126 may be a sealed inner volume so that wound fluid that is absorbed by absorbent core 106 is retained within inner volume 126 and is prevented or restricted from leaking out of inner volume 126. In other embodiments, dressing 100 includes a wound interface layer such as a fenestrated PU film layer. The wound interface layer may be configured to directly engage the wound 122 and may be positioned between the wound 122 and the absorbent core 106.
In some embodiments, wicking member 108 is also entirely positioned within inner volume 126. Wicking member 108 may abut, directly contact, engage, etc., the interior surface 105b of wound drape 104. Wicking member 108 can abut or engage or contact the interior surface 105b of wound drape 104 on one side and abut or engage absorbent core 106 on an opposite or interior or wound-facing side. Wicking member 108 may extend laterally along an exterior or outwards facing surface of absorbent core 106. In some embodiments, wicking member 108 extends between wound drape 104 and absorbent core 106 but is still positioned within inner volume 126 that is defined by wound drape 104. Wicking member 108 may extend laterally along the exterior surface of absorbent core 106 at a center point of absorbent core 106. In other embodiments, wicking member 108 extends laterally along the exterior surface of absorbent core 106 at a position that is offset from the center point of absorbent core 106. In still other embodiments, multiple wicking members 108 are used that extend in one or more lateral directions along absorbent core 106.
Wicking members 108 are intended, arranged, or configured to provide a wound fluid passage or pathway to direct wound fluid to an optional indicator (e.g., indicator assembly 110). In some embodiments, wicking member 108 are pre-existing infrastructure of the dressing 100. For example, wicking member(s) 108 can be configured to wick, transfer, etc., wound fluid from wound 122 to indicator assembly 110 or a position of indicator assembly 110 even if the indicator is not currently used. For example, the indicator may be optionally installed, attached, positioned, disposed, etc., on the dressing 100 if desired by a caregiver. In this way, wicking member(s) 108 may be pre-existing infrastructure of the dressing 100 and the dressing 100 can be optionally converted between an “indicator” dressing (e.g., when dressing 100 includes indicator assembly 110) and a “non-indicator” dressing (e.g., when dressing 100 does not include indicator assembly 110). Specifically, wicking member(s) 108 may facilitate defining, producing, or creating a wound fluid passageway from wound 122 to an opening, port, or aperture on dressing 100 (e.g., aperture 112 as described in greater detail below) which may be releasably covered and can optionally receive a variety of indicators for providing a visual indication of wound healing progress.
For example, wicking member 108 may extend laterally along at least one outer periphery of absorbent core 106 along a lateral axis 132. In other embodiments, more than one wicking member 108 extend along other lateral axes that are offset from lateral axis 132 or are perpendicular with lateral axis 132.
In some embodiments, wicking member 108 is coupled with wound drape 104 through the adhesive that is coated along the interior surface 105b of wound drape 104. In other embodiments, if wound drape 104 does not include adhesive along the interior surface 105b, wicking member 108 may include an adhesive along an exterior surface or the surface of wicking member 108 that engages, contacts, abuts, etc., interior surface 105b of wound drape 104. In still other embodiments, wicking member 108 and wound drape 104 do not include adhesive and wicking member 108 is retained in place relative to wound drape 104 by engagement between wicking member 108 and wound drape 104.
Wound drape 104 can include an opening, a hole, an aperture, a perforation, an exit opening, a fluid opening, etc., shown as aperture 112. In some embodiments, aperture 112 extends through an entire thickness of wound drape 104. For example, aperture 112 may be an opening that is formed in wound drape 104 and extends between the interior surface 105b and the exterior surface 105a of wound drape 104. In some embodiments, aperture 112 fluidly couples inner volume 126 with an external environment of dressing 100. For example, aperture 112 may extend through wound drape 104 such that fluid may exit inner volume 126 through aperture 112.
Aperture 112 can be positioned on wound drape 104 such that aperture 112 at least partially overlaps wicking member 108. In some embodiments, aperture 112 is positioned on wound drape 104 so that aperture 112 completely overlaps wicking member 108. For example, aperture 112 may be positioned on wound drape 104 so that fluid (e.g., wound fluid, wound exudate, etc.) can exit inner volume 126 of dressing 100 through aperture 112. In some embodiments, aperture 112 is a circular hole having a diameter that is 10-15 millimeters. In some embodiments, aperture 112 aligns with wicking member 108 so that wicking member 108 can provide fluid to or through aperture 112. In some embodiments, wicking member 108 provides fluid to or through aperture 112 even when absorbent core 106 is not fully or partially saturated.
In some embodiments, aperture 112 is pre-manufactured in wound drape 104. For example, aperture 112 may be present when dressing 100 is provided to a user or to a customer. In other embodiments, aperture 112 is created by a nurse, a caregiver, etc., when applying dressing 100 to wound 122. For example, the caregiver may cut a hole in wound drape 104 to provide aperture 112. In this way, the caregiver may readily convert any dressing that includes the wicking member 108 to a dressing with a wound status indicator.
In some embodiments, dressing 100 includes a pull-tab, a removable cover, a film member, a removable film, etc., shown as film cover 114. Film cover 114 may be removably coupled or removably attached with the exterior surface 105a of wound drape 104. Film cover 114 may adhere to the exterior surface 105a of wound drape 104. For example, wound drape 104 may include a ring 124 of adhesive that surrounds (e.g., circumferentially, peripherally, etc.) aperture 112. In some embodiments, film cover 114 covers aperture 112 such that when film cover 114 is removed, aperture 112 fluidly couples inner volume 126 with the external environment. Before film cover 114 is removed, film cover 114 may facilitate maintaining a sealed inner volume 126.
In some embodiments, removal of film cover 114 produces aperture 112. For example, film cover 114 may be adhered or attached to a portion of wound drape 104 that is perforated circumferentially. In some embodiments, removal of film cover 114 results in removal of the perforated portion of wound drape 104, thereby producing or providing aperture 112. Removal of film cover 114 may expose aperture 112 (e.g., if aperture 112 is already present in wound drape 104) or may produce aperture 112 (e.g., by tearing a perforated portion having a shape of aperture 112).
In some embodiments, if film cover 114 is adhered with the exterior surface 105a of wound drape 104, an adhesive bond strength between film cover 114 and wound drape 104 is approximately 50-60% of an adhesive bond strength between wound drape 104 and the patient's skin 102. Advantageously, this facilitates preventing unintentional removal of wound drape 104 from the patient's skin 102 when film cover 114 is removed. Advantageously, since the adhesive bond strength between film cover 114 and wound drape 104 is less than the adhesive bond strength between wound drape 104 and the patient's skin 102, removing film cover 114 will likely not result in removal of wound drape 104 from the patient's skin 102, or compromise of the seal between wound drape 104 and the patient's skin 102.
In some embodiments, film cover 114 is a PU film having a thickness of 50-100 microns. In some embodiments, film cover 114 is adhered with the exterior surface 105a of wound drape 104 using a PU gel adhesive. The adhesive may be positioned on the exterior surface 105a of wound drape 104 around aperture 112 or may be positioned on an under-side (e.g., a wound-facing or dressing-facing side) of film cover 114. In some embodiments, the adhesive has a thickness of 80-100 grams per square meter to ensure a seal and conformability of film cover 114 if film cover 114 is not removed and dressing 100 is used without wound status indication.
In some embodiments, wicking member 108 is or includes a polyvinylidene fluoride, polyvinylidene difluoride, non-woven fabric, sintered polymer sheet/foam, etc., material. Wicking member 108 can be any highly or suitably hydrophilic material such that fluid preferentially wicks along wicking member 108 before being absorbed into absorbent core 106. For example, fluid may be absorbed through or along wicking member 108 more quickly than absorbent core 106. In some embodiments, wicking member 108 has a hydrophilicity that is greater than a hydrophilicity of the absorbent core 106 so that fluid tends to wick along wicking member 108 before absorbent core 106. In some embodiments, wicking member 108 quickly establishes fluid communication between the wound and the indicator and operates during the remaining life of dressing as wicking member 108 absorbs wound fluid.
Referring still to
Indicator assembly 110 can include an attachment ring, an adhesive ring, etc., shown as adhesive ring 116 and an indicator, an indicator member, an indicator patch, etc., shown as indicator 118. In some embodiments, adhesive ring 116 is a PU film and may have a thickness of 50 microns. In some embodiments, indicator 118 is a PU film with a thickness of 50 microns. In some embodiments, indicator assembly 110 has an overall height that is negligible such that indicator 118 can engage, contact, abut, etc., wicking member 108.
In some embodiments, adhesive ring 116 is used to adhere or removably couple indicator 118 with wound drape 104. Adhesive ring 116 can include an interior side, an interior surface, a wound-facing surface, a wound-facing side, a dressing-facing surface, etc., shown as interior surface 117b and an exterior side, an exterior surface, an environment-facing surface, an environment-facing side, etc., shown as exterior surface 117a. In some embodiments, exterior surface 117a has an acrylic adhesive that is configured to form a strong and permanent bond between adhesive ring 116 and indicator 118. In some embodiments, the interior surface 117b of adhesive ring 116 includes a soft and/or conformable PU or other gel adhesive with a bond strength that is 50-60% of the adhesive bond strength between wound drape 104 and the patient's skin 102.
In some embodiments, indicator assembly 110 includes or is laminated with a liner, a cover, a protective release liner, etc., shown as removable liner 128. Removable liner 128 can be adhered to the interior surface 117b of adhesive ring 116 and may be removed by a caregiver to expose the adhesive on interior surface 117b of adhesive ring 116. In some embodiments, removable liner 128 protects the interior surface 117b of adhesive ring 116 before indicator assembly 110 is attached with wound drape 104. The user may remove removable liner 128 to expose the adhesive on interior surface 117b, and place adhesive ring 116 over aperture 112.
In some embodiments, adhesive ring 116 is a ring member having a central aperture, a central opening, a central hole, etc., shown as central opening 130. Central opening 130 may have a diameter or radius that is substantially equal to the diameter or radius of aperture 112. In some embodiments, central opening 130 facilitates the transfer of fluid from the inner volume 126 of dressing 100 to indicator 118.
Indicator 118 may be adhered or attached with adhesive ring 116 on the exterior surface 117a of adhesive ring 116. As described above, the exterior surface 117a of adhesive ring 116 may be at least partially coated with an adhesive to facilitate attaching indicator with adhesive ring 116.
In some embodiments, indicator 118 includes a responsive portion 120 that is configured to change color, opacity, shade, etc., in response to contacting fluid. The fluid can be transferred from the wound 122 to the responsive portion 120 through a pathway including the wicking member 108, aperture 112, and central opening 130. In some embodiments, responsive portion 120 is viewable from the external environment of dressing 100. For example, responsive portion 120 may be viewable from outside dressing 100 so a caregiver or user is provided with a visual indication of the status of wound 122 without requiring removal of dressing 100. In this way, indicator 118 may provide a visual indication to the caregiver or user even when dressing 100 is applied and remains undisturbed. In some embodiments, for example, indicator 118 may change color or opacity in response to a presence of a particular type of matter in the fluid exuded by the wound. For example, if the wound is infected, indicator 118 may change color to provide a visual indication to the caregiver or the user that the wound is infected.
In some embodiments, responsive portion 120 is an ink that is responsive to fluid, wound exudate, etc. Responsive portion 120 may be printed onto indicator 118. In some embodiments, responsive portion 120 is printed onto indicator 118 and indicator 118 is a hydrophilic material.
Referring still to
In some embodiments when dressing 100 is used in NPWT application, dressing 100 includes a negative pressure port, a valve, a vent, an opening, etc., shown as negative pressure port 136. For example, dressing 100 may be configured for use with a negative pressure unit (e.g., therapy device 602 as described in greater detail below with reference to
Referring particularly to
As shown in
Referring particularly to
Referring still to
Responsive portion 120 may be configured to change color, or opacity in response to the fluid wicked from wound 122 to indicator 118 along or through wicking member 108. For example, responsive portion 120 may be configured to change from a first color to a second color, or from opaque to transparent or vice versa, etc., in response to receiving fluid from wound 122 that includes bacteria. In some embodiments, responsive portion 120 is configured to provide a visual indication of whether or not wound 122 is infected (e.g., whether or not bacteria is present in the fluid exuded by wound 122) or to provide a visual indication of a progression of healing of wound 122. For example, responsive portion 120 may change color or opacity based on a type of fluid or based on a type of matter present (or a concentration of matter present) in the fluid exuded by wound 122 to indicate a healing status or healing progression of wound 122. Responsive portion 120 can function as a sensor, a detector, an indicator, etc., to provide a visual indication to the user or caregiver of whether or not wound 122 is infected (e.g., whether or not bacteria is present in the exuded wound fluid) or to provide a visual indication of a healing progression of wound 122. For example, as wound 122 heals and a concentration of a particular type of matter in the fluid decreases, responsive portion 120 may transition from a first color to a different color, a different shade of color, a different opacity, etc.
In some embodiments, indicator assembly 110 is optional. For example, dressing 100 may be used even without providing indicator assembly 110. Advantageously, when a caregiver wishes to test wound 122 to determine if wound 122 is infected or to determine a healing progression of wound 122, the caregiver may apply indicator assembly 110 to opening 130 and view responsive portion 120. The caregiver may also replace indicator assembly 110 with a different indicator assembly 110 to re-perform the test or conduct a different test. For example, the caregiver may apply different types of indicator assembly 110 with indicators 118 that change color or opacity to provide visual indications of wound healing, infection, etc. In some embodiments, indicator assembly 110 and dressing 100 function to draw the exuded wound fluid to indicator 118 so that the caregiver can view the exuded wound fluid to determine if wound 122 is infected or to determine a healing progression of wound 122. For example, responsive portion 120 may be replaced with a transparent or translucent film so that the fluid wicked by wicking member 108 is viewable by the caregiver through wound drape 104.
In some embodiments, indicator assembly 110 is removable and replaceable after applied to dressing 100. For example, the caregiver may remove indicator assembly 110 and replace indicator assembly 110 with another indicator assembly 110 to re-perform the test.
In some embodiments, dressing 100 can include a soft polymer adapter that is adhered proximate aperture 112. In some embodiments, the soft polymer adapter accepts a test strip via a wipe valve so that the user or caregiver may insert a larger test strip and test more measurands and/or assays. In some embodiments, the soft polymer adapter and/or the aperture 112 is in fluid connection with wicking member 108 via a valve (e.g., a one-way valve) so that the user or caregiver or a therapy unit may dose fluids to inner volume 126 and wound 122 to reduce bacteria and/or to change wound conditions to facilitate wound healing. In some embodiments, aperture 112 and/or a separate opening are configured to accommodate or receive a syringe nozzle.
Advantageously, dressing 100 may be optionally converted from a dressing without wound status indication into a dressing with wound status indication. Dressing 100 is a versatile dressing that can be converted for wound status indication and may be re-used with different indicators. Dressing 100 can also be advantageously configurable for different test strips, wound indicators, etc. For example, indicator assembly 110 may be removed and replaced multiple times over time to facilitate wound status indication or healing progression without requiring removal of dressing 100. Dressing 100 is capable of optionally receiving a diagnostic patch (e.g., indicator 118 and/or indicator assembly 110). Additionally, dressing 100 can accommodate a range of indicators which may be selected as appropriate by the user or the caregiver without the need for a different type of dressing for the various indicators. Further, dressing 100 provides the benefits of dressing 100 in addition to the benefits of indicator assembly 110 without requiring manufacturing of both dressing 100 and indicator assembly 110 together.
Referring particularly to
Process 500 includes providing a dressing having an absorbent core, a wicking structure, and a drape (step 502), according to some embodiments. In some embodiments, the drape has a removable portion that can be removed to define an aperture or opening in the drape to fluidly couple an interior volume of the dressing with exterior or external environment. For example, the drape may be wound drape 104 including film cover 114 that can be removed from wound drape 104 to expose aperture 112 which is positioned or aligned over wicking member 108, thereby fluidly coupling inner volume 126 with the environment that is external to dressing 100. In other embodiments, the drape does not include a removable portion, and aperture 112 is produced by making an incision in the drape at the wicking member. The dressing may be provided over a patient's wound and may sealingly couple (e.g., the drape may sealingly couple) with the patient's skin surrounding the wound. In some embodiments, the drape adheres to the patient's skin to define the inner volume of the dressing over the wound.
Process 500 includes removing the removable portion from the drape to expose the wicking structure to the external environment through an opening (step 504), according to some embodiments. In some embodiments, step 504 is performed by a technician, a nurse, a caregiver, etc., after the dressing has been applied to the wound. For example, step 504 can be performed by pulling or removing film cover 114 from wound drape 104. In some embodiments, film cover 114 is a perforated portion of wound drape 104 such that removal of film cover 114 produces aperture 112. In other embodiments, film cover 114 is a member that is adhered to the exterior surface of wound drape 104 and removal of film cover 114 exposes aperture 112 which is already formed in wound drape 104. Aperture 112 may be aligned on wicking member 108 or otherwise positioned such that aperture 112 fluidly couples the inner volume of the dressing with the external environment through wicking member 108.
Process 500 optionally includes producing an opening in the drape to expose the wicking structure to the external environment (step 506), according to some embodiments. In some embodiments, step 506 is performed if the dressing does not include the removable portion. For example, if the drape is continuous and does not include a perforated portion or a removable portion for producing or exposing the opening, step 506 may be performed. In some embodiments, step 506 is performed by a caregiver after or before the dressing is applied to the patient's wound. The caregiver may make an incision in the drape at the wicking structure to expose the wicking structure to the external environment through the incision (i.e., the opening).
Process 500 includes providing an indicator over the opening so that the indicator fluidly couples with the wicking structure (step 508), according to some embodiments. In some embodiments, the indicator sealingly couples with the exterior surface of the drape so that fluid can be provided to the indicator through the wicking structure and the opening, but is prevented or restricted from leaking through the sealed coupling between the indicator and the exterior surface of the drape.
Process 500 includes transferring fluid from a wound site, a wound bed, or the wound, to the indicator through the wicking structure and the opening (step 510), according to some embodiments. In some embodiments, the wicking structure is configured to wrap around the absorbent core to the wound site. The wicking structure can be more absorbent than the absorbent core so that fluid preferentially is absorbed, wicked, transferred, etc., through the wicking structure. In some embodiments, the wicking structure has a higher hydrophilicity than a hydrophilicity of the absorbent core. The wicking structure can be a laterally extending member that fluidly couples with both the opening in the drape and the wound site. In some embodiments, the wicking structure absorbs wound fluid faster, more rapidly, etc., than the absorbent core. In this way, the wicking structure may absorb, transfer, transport, wick, etc., wound fluid from the wound to the opening in the drape faster than fluid is absorbed into the absorbent core. In some embodiments, the wicking structure provides a rapid fluid delivery pathway from the wound to the opening (or the indicator) even when the absorbent core is only partially saturated, not saturated at all, or fully saturated.
Process 500 includes providing a visual indication of a wound status to a user (step 512), according to some embodiments. In some embodiments, step 512 is performed by the indicator. For example, the indicator may be manufactured from or include a material that is responsive to fluid. For example, the indicator may change color, opacity, etc., in response to contact with fluid that is exuded from the wound site and wicked to the indicator through the wicking structure. In some embodiments, the indicator may change color or opacity, or otherwise visually change in response to a presence of a particular type of matter in the fluid exuded by the wound. For example, the indicator may change color or opacity to provide a visual indication of infection of the wound. In some embodiments, the indicator is a test indicator that is configured to provide a visual indication of a status of the wound. The indicator may transition between different colors, different shades of a color, varying degrees of opacity, etc., in response to the fluid exuded from the wound and transferred to the indicator through the wicking structure. In this way, the indicator is viewable by a user without removal or disturbance of the dressing.
Referring now to
Therapy device 602 can be configured to provide negative pressure wound therapy by reducing the pressure at wound 122. Therapy device 602 can draw a vacuum at wound 122 (relative to atmospheric pressure) by removing wound exudate, air, and other fluids from wound 122. Wound exudate may include fluid that filters from a patient's circulatory system into lesions or areas of inflammation. For example, wound exudate may include water and dissolved solutes such as blood, plasma proteins, white blood cells, platelets, and red blood cells. Other fluids removed from wound 122 may include instillation fluid 605 previously delivered to wound 122. Instillation fluid 605 can include, for example, a cleansing fluid, a prescribed fluid, a medicated fluid, an antibiotic fluid, or any other type of fluid which can be delivered to wound 122 during wound treatment. Instillation fluid 605 may be held in an instillation fluid canister 604 and controllably dispensed to wound 122 via instillation fluid tubing 608. In some embodiments, instillation fluid canister 604 is detachable from therapy device 602 to allow canister 606 to be refilled and replaced as needed.
The fluids 607 removed from wound 122 pass through removed fluid tubing 610 and are collected in removed fluid canister 606. Removed fluid canister 606 may be a component of therapy device 602 configured to collect wound exudate and other fluids 607 removed from wound 122. In some embodiments, removed fluid canister 606 is detachable from therapy device 602 to allow canister 606 to be emptied and replaced as needed. A lower portion of canister 606 may be filled with wound exudate and other fluids 607 removed from wound 122, whereas an upper portion of canister 606 may be filled with air. Therapy device 602 can be configured to draw a vacuum within canister 606 by pumping air out of canister 606. The reduced pressure within canister 606 can be translated to wound dressing 100 and wound 122 via tubing 610 such that wound dressing 100 and wound 122 are maintained at the same pressure as canister 606.
Referring particularly to
Similarly, instillation pump 622 can be fluidly coupled to instillation fluid canister 604 via tubing 609 and fluidly coupled to wound dressing 100 via tubing 608. Instillation pump 622 can be operated to deliver instillation fluid 605 to wound dressing 100 and wound 122 by pumping instillation fluid 605 through tubing 609 and tubing 608, as shown in
Filter 628 can be positioned between removed fluid canister 606 and pneumatic pump 620 (e.g., along conduit 636) such that the air pumped out of canister 606 passes through filter 628. Filter 628 can be configured to prevent liquid or solid particles from entering conduit 636 and reaching pneumatic pump 620. Filter 628 may include, for example, a bacterial filter that is hydrophobic and/or lipophilic such that aqueous and/or oily liquids will bead on the surface of filter 628. Pneumatic pump 620 can be configured to provide sufficient airflow through filter 628 that the pressure drop across filter 628 is not substantial (e.g., such that the pressure drop will not substantially interfere with the application of negative pressure to wound 122 from therapy device 602).
In some embodiments, therapy device 602 operates a valve 632 to controllably vent the negative pressure circuit, as shown in
In some embodiments, therapy device 602 vents the negative pressure circuit via an orifice 158, as shown in
In some embodiments, therapy device 602 includes a variety of sensors. For example, therapy device 602 is shown to include a pressure sensor 630 configured to measure the pressure within canister 606 and/or the pressure at wound dressing 100 or wound 122. In some embodiments, therapy device 602 includes a pressure sensor 613 configured to measure the pressure within tubing 611. Tubing 611 may be connected to wound dressing 100 and may be dedicated to measuring the pressure at wound dressing 100 or wound 122 without having a secondary function such as channeling installation fluid 605 or wound exudate. In various embodiments, tubing 608, 610, and 611 may be physically separate tubes or separate lumens within a single tube that connects therapy device 602 to wound dressing 100. Accordingly, tubing 610 may be described as a negative pressure lumen that functions apply negative pressure wound dressing 100 or wound 122, whereas tubing 611 may be described as a sensing lumen configured to sense the pressure at wound dressing 100 or wound 122. Pressure sensors 630 and 613 can be located within therapy device 602, positioned at any location along tubing 608, 610, and 611, or located at wound dressing 100 in various embodiments. Pressure measurements recorded by pressure sensors 630 and/or 613 can be communicated to controller 618. Controller 618 use the pressure measurements as inputs to various pressure testing operations and control operations performed by controller 618.
Controller 618 can be configured to operate pneumatic pump 620, instillation pump 622, valve 632, and/or other controllable components of therapy device 602. In some embodiments, controller 618 operates pneumatic pump 620, instillation pump 622, valve 632, and/or other controllable components of therapy device 602 to draw a negative pressure at wound 122 and/or to provide instillation fluid to wound 122.
In some embodiments, therapy device 602 includes a user interface 626. User interface 626 may include one or more buttons, dials, sliders, keys, or other input devices configured to receive input from a user. User interface 626 may also include one or more display devices (e.g., LEDs, LCD displays, etc.), speakers, tactile feedback devices, or other output devices configured to provide information to a user. In some embodiments, the pressure measurements recorded by pressure sensors 630 and/or 613 are presented to a user via user interface 626. User interface 626 can also display alerts generated by controller 618. For example, controller 618 can generate a “no canister” alert if canister 606 is not detected.
In some embodiments, therapy device 602 includes a data communications interface 624 (e.g., a USB port, a wireless transceiver, etc.) configured to receive and transmit data. Communications interface 624 may include wired or wireless communications interfaces (e.g., jacks, antennas, transmitters, receivers, transceivers, wire terminals, etc.) for conducting data communications external systems or devices. In various embodiments, the communications may be direct (e.g., local wired or wireless communications) or via a communications network (e.g., a WAN, the Internet, a cellular network, etc.). For example, communications interface 624 can include a USB port or an Ethernet card and port for sending and receiving data via an Ethernet-based communications link or network. In another example, communications interface 624 can include a Wi-Fi transceiver for communicating via a wireless communications network or cellular or mobile phone communications transceivers.
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.
It should be noted that the term “exemplary” and variations thereof, as used herein to describe various embodiments, are intended to indicate that such embodiments are possible examples, representations, and/or illustrations of possible embodiments (and such terms are not intended to connote that such embodiments are necessarily extraordinary or superlative examples).
The term “coupled,” as used herein, means the joining of two members directly or indirectly to one another. Such joining may be stationary (e.g., permanent or fixed) or moveable (e.g., removable or releasable). Such joining may be achieved with the two members coupled directly to each other, with the two members coupled to each other using a separate intervening member and any additional intermediate members coupled with one another, or with the two members coupled to each other using an intervening member that is integrally formed as a single unitary body with one of the two members. Such members may be coupled mechanically, electrically, and/or fluidly.
References herein to the positions of elements (e.g., “top,” “bottom,” “above,” “below,” etc.) are merely used to describe the orientation of various elements in the FIGURES. It should be noted that the orientation of various elements may differ according to other exemplary embodiments, and that such variations are intended to be encompassed by the present disclosure.
The hydrophobicity of a material may vary, but to be considered hydrophobic, generally the material can have an average contact angle with water of at least 90 degrees in some embodiments. To be considered hydrophilic, generally the material can have a contact angle of most 90 degrees in some embodiments. In some embodiments the contact angle with water can be no more than 150 degrees. For example, in some embodiments, the contact angle of the hydrophobic material may be in a range of at least 70 degrees to about 120 degrees with an average contact angle of at least 90 degrees, or in a range of at least 120 degrees to 150 degrees. Water contact angles can be measured using any standard apparatus. Although manual goniometers can be used to visually approximate contact angles, contact angle measuring instruments can often include an integrated system involving a level stage, liquid dropper such as a syringe, camera, and software designed to calculate contact angles more accurately and precisely, among other things Non-limiting examples of such integrated systems may include the FTÅ125, FTÅ200, FTÅ2000, and FTÅ4000 systems, all commercially available from First Ten Angstroms, Inc., of Portsmouth, Va., and the DTA25, DTA30, and DTA100 systems, all commercially available from Kruss GmbH of Hamburg, Germany. Unless otherwise specified, water contact angles herein are measured using deionized and distilled water on a level sample surface for a sessile drop added from a height of no more than 5 cm in air at 20-25° C. and 20-50% relative humidity. Contact angles reported herein represent averages of 5-9 measured values, discarding both the highest and lowest measured values. The hydrophobicity of a material herein may be further enhanced with a hydrophobic coating of other materials, such as silicones and fluorocarbons, and by any means known, such as by coating by the other material (e.g., coated using a liquid that may be subsequently dried on the material) or plasma coated.
A hydrophobic material can be any material having a solubility in water of less than 10 mg/L at standard temperature and pressure. A hydrophilic material can be any material having a solubility in water of 10 mg/L and greater at standard temperature and pressure.
It is important to note that the construction and arrangement of the wound dressing with optional status indicator as shown in the various exemplary embodiments is 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 may be reversed or otherwise varied and the nature or number of discrete elements or positions may be altered or varied. Accordingly, all such modifications are intended to be included within the scope of the present disclosure. Other substitutions, modifications, changes, and omissions may be made in the design, operating conditions and arrangement of the exemplary embodiments without departing from the scope of the present disclosure.
Additionally, any element disclosed in one embodiment may be incorporated or utilized with any other embodiment disclosed herein. For example, the configuration and construction of dressing 10 of the exemplary embodiment described in at least paragraph [0067] may be incorporated in the dressing 10 of the exemplary embodiment described in at least paragraph [0036]. Although only one example of an element from one embodiment that can be incorporated or utilized in another embodiment has been described above, it should be appreciated that other elements of the various embodiments may be incorporated or utilized with any of the other embodiments disclosed herein.
This application claims the benefit of priority to U.S. Provisional Application No. 62/958,471, filed on Jan. 8, 2020, which is incorporated herein by reference in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/IB2021/050100 | 1/7/2021 | WO |
Number | Date | Country | |
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62958471 | Jan 2020 | US |