The present invention 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 negative pressure wound therapy systems with instillation therapy. Negative pressure wound therapy refers to the application of negative pressure (relative to atmospheric pressure) to a wound bed to facilitate healing of the wound bed. Negative pressure may be applied in coordination with instillation therapy, in which instillation fluid (e.g., cleansing fluid, medicated fluid, antibiotic fluid, irrigation fluid) is applied to the wound bed. Negative pressure and instillation wound therapy (NPWTi) may facilitate removal of wound exudate and other debris from the wound bed and otherwise support healing.
One common location for a wound (e.g., a burn) that could benefit from NPWTi is on a patient's hand. However, standard NPWTi dressings may be challenging to use on a hand due to the shape, size, contours, articulation, etc. of a hand. Accordingly, hand-specific dressings may facilitate improved NPWTi for hand wounds.
One implementation of the present disclosure is a dressing. The dressing includes a barrier film layer, a wound contact layer coupled to the barrier film layer, and a plurality of felted foam strips positioned between the barrier film layer and the wound contact layer. Each strip provides a manifolding pathway. The barrier film layer and the wound contact layer include a central region and a plurality of peninsular projections extending therefrom in the shape of a hand.
In some embodiments, each strip extends from the central region to one of the plurality of peninsular projections. The dressing can include a felted foam pad positioned at the central region, with the plurality of strips extending from the felted foam pad. The felted foam strips may be configured to allow airflow between the peninsular region and the felted foam pad. The dressing can include a connection assembly coupled to the barrier film layer at the felted foam pad. The connection assembly is configured to provide airflow between the felted foam pad and a tube coupled to the connection assembly.
In some embodiments, the barrier film layer and the wound contact layer are configured to form wrinkles therein when air is removed from the dressing via the felted foam strips. The wrinkles can allow fluid to flow therethrough.
In some embodiments, the felted foam strips include an open-cell foam. The wound contact layer and the barrier film layer may be configured to allow visual observation of a wound through the wound contact layer and the barrier film layer.
In some embodiments, the barrier film layer is welded to the wound contact layer around a perimeter of the barrier film layer and at a plurality of spot welds distributed amongst the plurality of felted foam strips. The spot welds constrain movement of the plurality of felted foam strips relative to the barrier film layer and the wound contact layer.
In some embodiments, the barrier film layer, the wound contact layer, and the plurality of felted foam strips are formed as a first side of a glove assembly. The first side of the glove assembly is coupled to a second side of the glove assembly to form the glove assembly. The second side of the glove assembly may include a second barrier film layer, a second wound contact layer coupled to the second barrier film layer, and a plurality of second felted foam strips positioned between the barrier film layer and the wound contact layer. Each strip provides a manifolding pathway. The dressing may include a felted foam cuff fluidly communicable with the plurality of felted foam strips of the first side and the plurality of second felted foam strips of the second side.
In some embodiments, the glove assembly is configured to receive a hand of a patient between the wound contact layer and the second wound contact layer. The dressing may include an adhesive configured to seal the first the first side and the second side to a wrist of the patient when the glove assembly receives the hand. The barrier film layer and the second barrier film layer provide a substantially airtight volume therebetween when the adhesive is sealed to the wrist of the patient.
Another implementation of the present disclosure is a wound therapy system. The wound therapy system includes a pump, a tube coupled to the pump, and a glove-shaped dressing coupled to the tube. The glove shaped dressing includes a barrier film layer, a wound contact layer coupled to the barrier film layer, and a plurality of felted foam strips positioned between the barrier film layer and the wound contact layer. The barrier film layer and the wound contact layer include a central region and a plurality of peninsular projections extending therefrom in the shape of a hand. Each of the plurality of felted foam strips extend from the central region to one of the plurality of peninsular projections.
In some embodiments, the felted foam strips are fluidly communicable with the pump via the tube. The pump is configured to draw a negative pressure at the felted foam strips. The barrier film layer and the wound contact layer may be configured to form wrinkles when the pump draws the negative pressure at the felted foam strips. The wrinkles can allow airflow therethrough. In some embodiments, the barrier film layer and the wound contact layer are configured to allow a wound to be visually observed therethrough.
In some embodiments, the wound therapy system includes a felted foam pad positioned at the central region. The plurality of felted foam strips extend from the felted foam pad and the tube is coupled to the glove-shaped dressing proximate the felted foam pad.
Another implementation of the present disclosure is a method. The method includes inserting a hand of a patient into a glove-shaped dressing. The glove-shaped dressing includes a wound contact layer, a barrier film layer, and a plurality of felted foam strips positioned between the barrier film layer and the wound contact layer. The method also includes sealing the glove-shaped dressing around a wrist of the patient, coupling the glove-shaped dressing to a pump such that the pump is in fluid communication with the plurality of felted foam strips, and operating the pump to remove air from the felted foam strips.
In some embodiments, the method includes forming creases in the barrier film layer by operating the pump to remove air from the glove-shaped dressing via the felted foam strips. Operating the pump may cause fluid to flow through the creases.
In some embodiments, coupling the glove-shaped dressing to the pump comprises positioning a connection pad on the barrier film layer at a felted foam pad. The plurality of felted foam strips extend from the felted foam pad. The method may also include coupling a tube to the pump and the connection pad.
Referring to
Although the examples described herein show a NPWTi system 100 configured to provide both negative pressure wound therapy and instillation therapy, in other embodiments the system 100 is configured to provide negative pressure wound therapy (NPWT) without instillation therapy.
The dressing 104 is coupleable to a wound bed, i.e., a location of a wound (e.g., sore, laceration, burn, etc.) on a patient. In the examples herein, the dressing 104 is configured to be placed on a hand of a patient to cover a wound bed located on the hand. The dressing 104 may be substantially sealed over/around the wound bed such that a pressure differential may be maintained between the atmosphere and the wound bed (i.e., across the dressing 104). The dressing 104 may be coupled to the vacuum tube 106 and the instillation tube 108, for example to place the vacuum tube 106 and/or the instillation tube 108 in fluid communication with the wound bed. Embodiments of the dressing 104 are shown in
The dressing 104 includes one or more sensors 204. The one or more sensor(s) 204 are configured to measure one or more physical parameters at the dressing and provide the measurements to the control circuit 202, for example by transmitting the measurements via wireless communications (e.g., via a wireless network such as Bluetooth, WiFi, etc.). In the embodiments shown herein, the one or more sensor(s) 104 include a humidity sensor configured to measure humidity at the dressing 104, a moisture sensor configured to measure moisture at the dressing 104, and a strain sensor configured to measure a strain on the dressing 104. In some embodiments, the one or more sensor(s) 204 include one or more pH sensors to measure tissue pH or fluid pH.
The therapy unit 102 includes a negative pressure pump 112 (shown in
Operating the negative pressure pump 112 may therefore both create a negative pressure at the wound bed and remove undesirable fluid and debris from the wound bed. In some cases, operating the negative pressure pump 112 may cause deformation of the wound bed and/or provide other energy to the wound bed to facilitate debridement and healing of the wound bed. In various embodiments, the negative pressure pump 112 may be operated to provide various levels (amounts, values, etc.) of negative pressure at the wound bed (e.g., 30 mmHg, 60 mmHg, 75 mmHg, 125 mmHg, 150 mmHg, etc.) for example varying over time as part of a dynamic pressure control approach. In the embodiments described below, the negative pressure pump 112 is configured to operate, as controlled by the control circuit 202, to provide a first level of negative pressure at the wound bed corresponding to a wound therapy mode (e.g., 125 mmHg) and a second level of negative pressure at the wound bed corresponding to a physiotherapy mode (e.g., 60 mmHg), where the second level is closer to ambient air pressure than the first level.
The therapy unit 102 also includes an instillation pump 116. The instillation pump 116 is configured to selectively provide instillation fluid from the instillation fluid source 110 to the dressing 104. The instillation pump 116 is operable to control the timing and amount (volume) of instillation fluid provided to the dressing 104. The instillation pump 116 may be controlled in coordination with the negative pressure pump 112 to provide one or more wound treatment cycles that may facilitate wound healing. In some embodiments, the amount of fluid provided by the instillation pump is automatically determined using a wound volume estimation process executed by the therapy unit 102.
The therapy unit 102 is also shown to include an input/output device 118. The input/output device 118 is configured to provide information relating to the operation of the NPWTi system 100 to a user and to receive user input from the user. The input/output device 118 may display status information relating to the NPWTi system 100, for example including measurements obtained from the sensor(s) 204 of the dressing 104 or the sensor(s) 200 of the therapy unit 102. The input/output device 118 may allow a user to input various preferences, settings, commands, etc. that may be used in controlling the negative pressure pump 112 and the instillation pump 116 as described in detail below. The input/output device 118 may include a display (e.g., a touchscreen), one or more buttons, one or more speakers, and/or various other devices configured to provide information to a user and/or receive input from a user.
As shown in
The control circuit 202 is configured to control the operation of the therapy unit 102, including by controlling the negative pressure pump 112, the instillation pump 116, and the input/output device 118. The control circuit 202 may receive measurements from the sensor(s) 200 and the sensor(s) 204 and/or user input from the input/output device 118 and use the measurements and/or the user input to generate control signals for the instillation pump 116 and/or the negative pressure pump 112. For example, the control circuit 202 may control the negative pressure pump 112 and the instillation pump 116 to provide various combinations of various instillation phases, soak periods, and negative pressure phases (i.e., various pressures and instillation amounts over various durations) to support and encourage wound healing. As another example, as described in detail below with reference to
Referring now to
In
The dressing 104 is also shown to includes a first fenestrated film layer 308 that abuts the first manifold layer 300 with and a second fenestrated film layer 308 that abuts the second manifold layer 302. The first manifold layer 300 is positioned between the first fenestrated film layer 308 and the first barrier layer 304, and the second manifold layer 302 is positioned between the second fenestrated film layer 310 and the second barrier layer 306. In some embodiments, the first fenestrated film layer 308 is coupled to the first manifold layer 300 by an adhesive and/or the second fenestrated film layer 310 is coupled to the second manifold layer 302 by an adhesive. In preferred embodiments. The first fenestrated film layer 308 is configured to be easily separated from the second fenestrated film layer 310. That is, the first fenestrated film layer 308 and the second fenestrated film layer 310 are configured to not adhere to one another.
As illustrated in
The first barrier layer 304 is coupled to the second barrier layer 306 along a hand portion of a perimeter of the dressing 104 and separated from the second barrier layer 306 along a wrist portion 320 of the perimeter of the dressing 104. The first barrier layer 304 is not coupled to the second barrier layer 306 along the wrist portion 320 of the perimeter of the dressing 104, which creates an opening that allows a patient's hand to be inserted into the dressing 104. In other words, the dressing 104 is formed as a glove. The dressing 104 is thereby configured to receive a patient's hand between the first fenestrated film layer 308 and the second fenestrated film layer 310.
In the example shown, the first barrier layer 304 is coupled to the second barrier layer 306 along edges of the peninsular regions 314 and the central region 312 by film welds 316, and along a portion of the perimeter of the central region by anchor welds 318.
The dressing 104 is also shown to include an adhesive cuff 322. Adhesive cuff 322 includes an adhesive (or multiple adhesives) configured to seal the adhesive cuff 322 to the first barrier layer 304 and the second barrier layer 306 along the wrist portion 320 of the perimeter of the dressing and to skin of a patient. The adhesive cuff 322 extends from the first barrier layer 304 and the second barrier layer 306 such that the adhesive cuff 322 is configured to be coupled to a wrist of a patient when the patient's hand is inserted into the dressing 104. When the adhesive cuff 322 is sealed to a patient's wrist, the first barrier layer 304, and the second barrier layer 306, the adhesive cuff 322 substantially prevents air from flowing between an ambient environment and the interior of dressing 104 (e.g., the manifold layers 300, 302) via the opening at the wrist portion 320 of the dressing 104. The adhesive cuff 322 may be produced as an integrated piece of the dressing 104 or may be distributed as a separate piece of a dressing kit (e.g., as an adhesive strip).
The barrier layers 304, 306 are configured to substantially prevent airflow therethrough. The barrier layers 304, 306 may include a polyurethane drape material, for example a drape material as used in a V.A.C.® Drape by Acelity. As mentioned above, the barrier layers 304, 306 are sealed with a substantially-airtight seal by film welds 316. Accordingly, when the adhesive cuff 322 is sealed around the wrist of a patient and the barrier layers 304, 306, a substantially airtight volume is created within the dressing 104, i.e., between the barrier layers 304, 306 and the patient's hand. The barrier layers 304, 306 may each have a thickness in a range between approximately 80 and 120 microns.
As shown in
The fenestrated film layers 308, 310 are made of a non-adherent film and are configured to provide a non-adherent interface between the dressing 104 and a hand of a patient, including a wound bed located on the hand. The fenestrated film layers 308, 310 are also configured to prevent ingrowth of skin to the dressing (e.g., healing into the manifold layers 300, 302). The fenestrated film layer 308, 310 thereby facilitate easy insertion of a hand into the dressing 104 and removal of the hand from the dressing 104. Additionally, the fenestrated film layers 308, 310 have fenestrations (perforations, holes, airways, windows, etc.) extending therethrough that allow air and fluid to pass between the hand (e.g., a wound bed) and the manifold layers 300, 302. The fenestrated film layers 308 may each have a thickness of approximately 30 microns.
The manifold layers 300, 302 are configured to allow air and fluid to flow therethrough. The manifold layers are made of an open-cell foam, for example a reticulated polyurethane open cell foam. In some embodiments, the manifold layers 300, 302 are made of an open-cell foam marketed as GRANUFOAM™ by ACELITY™. The manifold layers 300, 302 may each have a thickness in a range between approximately 6 mm and 10 mm. Accordingly, the manifold layers 300, 302 may be thinner than in conventional bulky dressings. The reduced thickness of the manifold layers 300, 302 facilitates flexion of the dressing 104 to allow for physiotherapy for the hand in the dressing 104 in a way not previously achieved.
The manifold layers 300, 302 allow for the communication of air pressure, for example negative pressure (relative to ambient air pressure), through the manifold layers 300, 302 and to the hand and the wound bed (via the fenestrated film layers 308, 310. The dressing 104 is configured such that air and fluid can flow between the first manifold layer 300 and the second manifold layer 302 proximate the film welds 316 and anchor welds 318, i.e., through the fenestrated film layers 308, 310 and around a hand positioned in the dressing 104. Negative pressure can thereby be communicated across both manifold layers 300, 302 (i.e., such that both manifold layers 300, 302 are maintained at approximately equal pressures).
The dressing 104 is configured to be coupled to a vacuum (negative pressure) tube 106 and, in some embodiments, an instillation tube 108. For example, a hole may be cut in the first barrier layer 304 (e.g., with a diameter in a range between approximately 3-20 mm) and a connection pad may be coupled to the barrier layer 304 over the hole. The connection pad is coupled to the vacuum tube 106 and/or instillation tube 108. In some embodiments, multiple holes and/or connection pads are used. For example, the connection pad may be a SENSAT.R.A.C.™ connection pad marketed by ACELITY™.
The manifold layers 300, 302 can thereby be put in fluid communication with the vacuum tube 106 and/or instillation tube 108. As described above with reference to
Still referring to
Referring now to
The wound-dressing interface 700 includes a patient interface layer 702 and a foam interface layer 704. The foam interface layer 704 includes a fenestrated film, for example a polyurethane or polyethylene film with fenestrations extending therethrough. The foam interface layer 704 allows air and fluid to flow therethrough and limits adherence of the wound-dressing interface 700 to the manifold layers 300, 302. The patient interface layer 702 includes a perforated silicone and a hydrogel or polyurethane gel. The patient interface layer 702 is configured to adhere to itself. In some embodiments, the patient interface layer 702 is configured to adhere to skin.
The wound-dressing interface 700 is thereby configured to be folded over a hand and adhered to itself (mated to itself) to substantially enclose the hand in the wound dressing interface 700 such that the patient interface layer 702 faces inwards (i.e., towards the hand) and the foam interface layer 704 faces outwards (i.e., away from the hand). The hand and the wound-dressing interface 700 can then be inserted into the glove portion of the dressing 104, i.e., the barrier layers 304, 306 and the manifold layers 300, 302 arranged as described above (and as shown in
The embodiments of
Referring now to
At step 1002, the negative pressure pump 112 is operated to establish a first level of negative pressure at the glove-shaped dressing 104. The first level of negative pressure may correspond to a preferred level for negative pressure wound therapy, for example in the range of approximately 100 mmHg to 175 mmHg of negative pressure. When the first level of negative pressure is applied, the pressure differential between the ambient air and the interior of the dressing 104 increases the rigidity of the dressing 104 such that dressing 104 substantially restricts (limits, prevents, etc.) articulation of the hand.
At step 1004, a measurement is received from the strain sensor 326 on the glove-shaped dressing 104. The measurement includes a current value of a strain on the dressing 104. The strain on the dressing 104 may correspond to an amount of force exerted on the dressing 104 by the hand in the dressing 104 in an attempt to curl, bend, articulate, etc. the fingers in the dressing 104. The measurement may be received by the control circuit 202 via a wireless network (e.g., Bluetooth communications, WiFi communications, etc.).
At step 1006, the measurement is compared to a threshold strain value. The threshold strain value may be predetermined, for example by bench testing. The threshold strain value corresponds to a significant probability that the patient is deliberately attempting to articulate the hand in the dressing 104. In the measurement does not exceed the threshold measurement, pump 112 continues to be controlled to provide the first level of negative pressure at the dressing 104 while more measurements of the strain are received at the control circuit 202 over time.
If a determination is made that the measurement of the strain exceeds the threshold strain value, a physiotherapy mode is initiated at step 1008. At step 1008, the pump 112 is controlled (e.g., by the control circuit 202) to reduce the negative pressure from the first level of negative pressure to a second level of negative pressure. The second level of negative pressure is “lower” than the first level of negative pressure, i.e., closer to atmospheric pressure (e.g., in a range of approximately 25 mmHg to 75 mmHg). At the second level of negative pressure, the rigidity of the dressing 104 is lower than at the first level of negative pressure. Accordingly, at the second level of negative pressure, the dressing 104 and the NPWIT system 100 allows the patient to at least partially bend, articulate, move, etc. the fingers and hand in the dressing 104. For example, the patient may follow guided instructions from a therapist. In some embodiments, the therapy unit is configured to provide instructions for a physiotherapy routine to a user via the input/output device 118.
At step 1010, additional measurements of the strain are received from the strain sensor 234. As the patient continues to articulate the hand in the dressing 104, the strain will stay above the threshold strain value and/or repeatedly exceed the threshold strain value. At step 1012, a determination is made of whether the measurement has fallen below the threshold strain value for at least a threshold duration of time. The threshold duration of time may be selected as indicative that the patient has ended a physiotherapy routine or other attempt to articulate the hand in the dressing 104. If the strain has not fallen below the threshold strain value for at least the threshold duration of time, the pump 112 continues to be controlled to maintain the second level of negative pressure at the dressing.
If the strain has fallen below the threshold strain value for at least the threshold duration of time, the pump 112 is controlled to reestablish the first level of negative pressure at the dressing at step 1014, i.e., to reestablish an optimal NPWTi regime and exit the physiotherapy mode. The process may then return to step 1004 where the strain measurements are monitored. Repeated iterations of the physiotherapy mode may thereby be initiated and exited to facilitate both physiotherapy and NPWTi for the hand in the dressing 104 over time. With the advantages described above, the dressing 104 may be well-suited for long-term application to the hand (e.g., seven days or longer).
Several variations on the process 1000 are also contemplated by the present disclosure. For example, in some embodiments, the physiotherapy mode can be initiated or ended in response to user input to the input/output device 118 commanding a start or end to the physiotherapy mode. As another example, the control circuit 202 may prevent execution of the process 1000 (e.g., prevent initiation of physiotherapy mode) during an instillation cycle (e.g., while instillation fluid is being supplied to the dressing 104). As another example, in some embodiments, a dynamic pressure control mode (e.g., cyclic variations in negative pressure) is applied outside of the physiotherapy mode (e.g., in place of the first level of negative pressure). Various such variations are possible.
Additionally, although the embodiments described herein are designed for use on hands, variations suitable for use on feet or amputation stumps are also within the scope of the present disclosure. For example, a variation suitable for use on a foot may be formed as a sock, with or without a separate pocket/projection for each toe, rather than as a glove as shown for the hand dressings described above. Variations of the dressing 104 can therefore be tailored for use in treating wounds in many anatomical locations.
The dressing 104 and NPWTi system 100 described above provide various advantages over existing dressings and wound therapy systems. The dressing 104 is easy to apply (thereby reducing application time) and remove without damaging the healed/healing wound (e.g., by avoiding a risk of in-growth into the dressing structure). The dressing 104 and NPWTi system 100 also allow for effective positioning of the dressing 104 while also allowing early movement in the full range of motion (or at least a significant portion of the range of motion) of the wounded/treated hand. The dressing 104 and NPWTi system 100, in the embodiments shown, are suitable for providing negative pressure and instillation therapy for up to at least seven days. The dressing 104 may reduce the use of foam relative to existing dressings, thereby making the dressing 104 smaller and less cumbersome for the patient. The dressing 104 and the NPWTi system 100, in the embodiments shown, also provide for an automatic physiotherapy mode that facilitates rehabilitation and reduces the risk of contractures. Additionally, the dressing 104 includes sensors that wirelessly (e.g., without the annoyance/complication of additional cables/wires/etc.) communicate useful measurements/diagnostics to a caregiver that allow early detection of infection or other developments in wound treatment. Therefore, the dressing 104 and NPWTi system 100 disclosed herein provide many advantages over existing systems that can improve outcomes for patients while also improving the overall treatment experience.
Referring now to
As shown in
In the example of
The connection surface 1106 provides an area of felted foam having a sufficient surface area to allow connection of the dressing 104 to the tube 106 in fluid communication with the manifolding layer 300 (i.e., with the wrist strap 1104 and the felted foam strips 1100). In the example shown, the felted foam strips 1100 and the wrist strap 1104 may be narrow (e.g., having a width less than a diameter of a connection pad 1108 which couples the dressing 104 to the vacuum tube 106 and, in some embodiments, to the instillation tube 108. The connection surface 1106 provides a larger surface area (e.g., having a diameter equal to or larger than the diameter of the connection pad 1108; having a diameter in a range between approximately ten millimeters and approximate twenty-five millimeters, for example approximately twenty millimeters; etc.) which allows the tube 106 to be placed in fluid communication with the manifolding layer 300. In the example shown in
As shown in
In the example of
In some embodiments, the barrier film layers 304, 306 and the fenestrated film layers 308 are transparent or translucent. In such embodiments and in regions unoccupied by the felted foam strips 1100, the dressing 104 can be transparent or translucent. Accordingly, in the embodiments of
The first side 1110 and the first side 1112 may be coupled together by welds 316 and/or 318 around a perimeter of the dressing 104 with the exception of an opening at a wrist portion 320 of the perimeter of the dressing 104 (e.g., as described above with reference to
To transition from the first frame 1601 to the second frame 1602, the negative pressure pump 112 is operated to remove air and/or other fluids or debris from the dressing 104 via the tube 106, the connection pad 1108, the felted foam pad 1102, and the felted foam strips 1100 to establish a negative pressure within the dressing 104 and at the hand (e.g., at a wound). Operating the negative pressure pump 112 results in a reduction in volume of the dressing 104 as the dressing 104 is pulled inwards towards the hand by the pressure differential across the barrier film layers 304, 306.
As illustrated in the second frame 1602, the reduction in volume of the dressing 104 in response to operation of the negative pressure pump 112 results in the formation of wrinkles (creases, folds, etc.) in the barrier film layers 304, 306 and the fenestrated film layers 308, 310. The wrinkles may form with openings, gaps, channels, airways, etc. in and across the wrinkles, such that at least a portion of the wrinkles provide manifolding pathways for air and fluid flow. For example, gaps, channels, etc. may be formed between the barrier film layers 304, 306 and the fenestrated film layers 308, 310. Furthermore, at least a portion of the wrinkles are in fluid and/or pneumatic communication with the felted film strips 1100. Accordingly, air and fluid can flow between the felted film strips 1100 and regions of the hand not directly aligned with the felted foam strips 1100.
Therefore, although the felted foam strips 1100 cover only a portion of the surface area of the dressing 104 and the hand treated thereby, the wrinkles formed by operation negative pressure pump 112 can provide air and fluid manifolding to a much larger portion of the surface area of the dressing 104 and the hand (e.g., to the substantially the entire hand). The dressing 104 thereby facilitates the establishment and maintenance of a negative pressure at the hand, removal of wound exudate and other fluid/debris from the hand, and, in some embodiments, instillation of an instillation fluid to the hand. Furthermore, as the (substantially opaque) felted foam material covers only a portion of the surface area of the dressing 104, a patient or caregiver can visually inspect a wound without removing the dressing 104, including while negative pressure is established at the hand.
In some embodiments, one or more thermo-chromic indicators are positioned on the fenestrated film layers 308, 310, for example on the inner (i.e., hand-facing) surface or outer (i.e., non-hand-facing) surface of the fenestrated film layers 308, 310. The thermo-chromic indicators are configured to change color with changes in temperature, such that the color of a thermo-chromic indictor is indicative of the temperature of the skin or wound bed proximate the thermo-chromic indicator. Because the dressing 104 of
Various other embodiments of the dressing 104 are also possible. For example, in some embodiments the felted foam strips 1100 are non-felted. That is, the foam strips 1100 may be made of an open-celled polyurethane foam which may or may not be felted (e.g., heated and compressed) in various embodiments. In other embodiments, the felted foam strips 1100 are replaced by non-foam thermoformed pathways, for example tubes or other pathways formed on or coupled to the barrier film layer (e.g., formed of a polyurethane drape material). In other embodiments, various spacer materials are positioned to cause the wrinkles to form in a desired pattern, in some cases such that some or all of the felted foam strips 1100 can be omitted.
Although the embodiments herein are described with reference to a dressing shaped for a hand, the dressings, systems, and methods disclosed herein may be adapted for use with feet, amputation stumps, and other extremities. Furthermore, various combinations of the features and embodiments described herein are possible. For example, in some embodiments, the first side 1110 of the dressing 104 includes the felted foam strips as in
Although the figures show a specific order of method steps, the order of the steps may differ from what is depicted. Also two or more steps can be performed concurrently or with partial concurrence. Such variation will depend on the software and hardware systems chosen and on designer choice. All such variations are within the scope of the disclosure. Likewise, software implementations could be accomplished with standard programming techniques with rule based logic and other logic to accomplish the various connection steps, calculation steps, processing steps, comparison steps, and decision steps.
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. 62/881,591, filed on Aug. 1, 2019, which is incorporated herein by reference in its entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IB2020/057197 | 7/30/2020 | WO |
| Publishing Document | Publishing Date | Country | Kind |
|---|---|---|---|
| WO2021/019486 | 2/4/2021 | WO | A |
| Number | Name | Date | Kind |
|---|---|---|---|
| 1355846 | Rannells | Oct 1920 | A |
| 2547758 | Keeling | Apr 1951 | A |
| 2632443 | Lesher | Mar 1953 | A |
| 2682873 | Evans et al. | Jul 1954 | A |
| 2910763 | Lauterbach | Nov 1959 | A |
| 2969057 | Simmons | Jan 1961 | A |
| 3066672 | Crosby, Jr. et al. | Dec 1962 | A |
| 3367332 | Groves | Feb 1968 | A |
| 3520300 | Flower, Jr. | Jul 1970 | A |
| 3568675 | Harvey | Mar 1971 | A |
| 3648692 | Wheeler | Mar 1972 | A |
| 3682180 | McFarlane | Aug 1972 | A |
| 3826254 | Mellor | Jul 1974 | A |
| 4080970 | Miller | Mar 1978 | A |
| 4096853 | Weigand | Jun 1978 | A |
| 4139004 | Gonzalez, Jr. | Feb 1979 | A |
| 4165748 | Johnson | Aug 1979 | A |
| 4184510 | Murry et al. | Jan 1980 | A |
| 4233969 | Lock et al. | Nov 1980 | A |
| 4245630 | Lloyd et al. | Jan 1981 | A |
| 4256109 | Nichols | Mar 1981 | A |
| 4261363 | Russo | Apr 1981 | A |
| 4275721 | Olson | Jun 1981 | A |
| 4284079 | Adair | Aug 1981 | A |
| 4297995 | Golub | Nov 1981 | A |
| 4333468 | Geist | Jun 1982 | A |
| 4373519 | Errede et al. | Feb 1983 | A |
| 4382441 | Svedman | May 1983 | A |
| 4392853 | Muto | Jul 1983 | A |
| 4392858 | George et al. | Jul 1983 | A |
| 4419097 | Rowland | Dec 1983 | A |
| 4465485 | Kashmer et al. | Aug 1984 | A |
| 4475909 | Eisenberg | Oct 1984 | A |
| 4480638 | Schmid | Nov 1984 | A |
| 4525166 | Leclerc | Jun 1985 | A |
| 4525374 | Vaillancourt | Jun 1985 | A |
| 4540412 | Van Overloop | Sep 1985 | A |
| 4543100 | Brodsky | Sep 1985 | A |
| 4548202 | Duncan | Oct 1985 | A |
| 4551139 | Plaas et al. | Nov 1985 | A |
| 4569348 | Hasslinger | Feb 1986 | A |
| 4605399 | Weston et al. | Aug 1986 | A |
| 4608041 | Nielsen | Aug 1986 | A |
| 4640688 | Hauser | Feb 1987 | A |
| 4655754 | Richmond et al. | Apr 1987 | A |
| 4664662 | Webster | May 1987 | A |
| 4710165 | McNeil et al. | Dec 1987 | A |
| 4733659 | Edenbaum et al. | Mar 1988 | A |
| 4743232 | Kruger | May 1988 | A |
| 4758220 | Sundblom et al. | Jul 1988 | A |
| 4787888 | Fox | Nov 1988 | A |
| 4826494 | Richmond et al. | May 1989 | A |
| 4838883 | Matsuura | Jun 1989 | A |
| 4840187 | Brazier | Jun 1989 | A |
| 4863449 | Therriault et al. | Sep 1989 | A |
| 4872450 | Austad | Oct 1989 | A |
| 4878901 | Sachse | Nov 1989 | A |
| 4897081 | Poirier et al. | Jan 1990 | A |
| 4906233 | Moriuchi et al. | Mar 1990 | A |
| 4906240 | Reed et al. | Mar 1990 | A |
| 4919654 | Kalt | Apr 1990 | A |
| 4941882 | Ward et al. | Jul 1990 | A |
| 4953565 | Tachibana et al. | Sep 1990 | A |
| 4969880 | Zamierowski | Nov 1990 | A |
| 4985019 | Michelson | Jan 1991 | A |
| 5037397 | Kalt et al. | Aug 1991 | A |
| 5086170 | Luheshi et al. | Feb 1992 | A |
| 5092858 | Benson et al. | Mar 1992 | A |
| 5100396 | Zamierowski | Mar 1992 | A |
| 5134994 | Say | Aug 1992 | A |
| 5149331 | Ferdman et al. | Sep 1992 | A |
| 5167613 | Karami et al. | Dec 1992 | A |
| 5176663 | Svedman et al. | Jan 1993 | A |
| 5215522 | Page et al. | Jun 1993 | A |
| 5232453 | Plass et al. | Aug 1993 | A |
| 5261893 | Zamierowski | Nov 1993 | A |
| 5278100 | Doan et al. | Jan 1994 | A |
| 5279550 | Habib et al. | Jan 1994 | A |
| 5298015 | Komatsuzaki et al. | Mar 1994 | A |
| 5342376 | Ruff | Aug 1994 | A |
| 5344415 | DeBusk et al. | Sep 1994 | A |
| 5358494 | Svedman | Oct 1994 | A |
| 5437622 | Carion | Aug 1995 | A |
| 5437651 | Todd et al. | Aug 1995 | A |
| 5527293 | Zamierowski | Jun 1996 | A |
| 5549584 | Gross | Aug 1996 | A |
| 5556375 | Ewall | Sep 1996 | A |
| 5607388 | Ewall | Mar 1997 | A |
| 5636643 | Argenta et al. | Jun 1997 | A |
| 5645081 | Argenta et al. | Jul 1997 | A |
| 6071267 | Zamierowski | Jun 2000 | A |
| 6135116 | Vogel et al. | Oct 2000 | A |
| 6241747 | Ruff | Jun 2001 | B1 |
| 6287316 | Agarwal et al. | Sep 2001 | B1 |
| 6345623 | Heaton et al. | Feb 2002 | B1 |
| 6488643 | Tumey et al. | Dec 2002 | B1 |
| 6493568 | Bell et al. | Dec 2002 | B1 |
| 6553998 | Heaton et al. | Apr 2003 | B2 |
| 6814079 | Heaton et al. | Nov 2004 | B2 |
| 7846141 | Weston | Dec 2010 | B2 |
| 8062273 | Weston | Nov 2011 | B2 |
| 8216198 | Heagle et al. | Jul 2012 | B2 |
| 8251979 | Malhi | Aug 2012 | B2 |
| 8257327 | Blott et al. | Sep 2012 | B2 |
| 8398614 | Blott et al. | Mar 2013 | B2 |
| 8449509 | Weston | May 2013 | B2 |
| 8529548 | Blott et al. | Sep 2013 | B2 |
| 8535296 | Blott et al. | Sep 2013 | B2 |
| 8551060 | Schuessler et al. | Oct 2013 | B2 |
| 8568386 | Malhi | Oct 2013 | B2 |
| 8679081 | Heagle et al. | Mar 2014 | B2 |
| 8834451 | Blott et al. | Sep 2014 | B2 |
| 8926592 | Blott et al. | Jan 2015 | B2 |
| 9017302 | Vitaris et al. | Apr 2015 | B2 |
| 9198801 | Weston | Dec 2015 | B2 |
| 9211365 | Weston | Dec 2015 | B2 |
| 9289542 | Blott et al. | Mar 2016 | B2 |
| 20020077661 | Saadat | Jun 2002 | A1 |
| 20020115951 | Norstrem et al. | Aug 2002 | A1 |
| 20020120185 | Johnson | Aug 2002 | A1 |
| 20020143286 | Tumey | Oct 2002 | A1 |
| 20050186260 | Narini et al. | Aug 2005 | A1 |
| 20070000021 | Yang | Jan 2007 | A1 |
| 20080312613 | Heaton | Dec 2008 | A1 |
| 20110224630 | Simmons | Sep 2011 | A1 |
| 20130198938 | Birnbaum | Aug 2013 | A1 |
| 20140094761 | Corley | Apr 2014 | A1 |
| 20140163491 | Schuessler et al. | Jun 2014 | A1 |
| 20150080788 | Blott et al. | Mar 2015 | A1 |
| 20150320603 | Locke | Nov 2015 | A1 |
| 20160144084 | Collinson | May 2016 | A1 |
| 20170007751 | Hartwell | Jan 2017 | A1 |
| 20170049943 | Balasubramaniam | Feb 2017 | A1 |
| 20180140755 | Blott | May 2018 | A1 |
| 20180353339 | Locke et al. | Dec 2018 | A1 |
| Number | Date | Country |
|---|---|---|
| 550575 | Mar 1986 | AU |
| 745271 | Mar 2002 | AU |
| 755496 | Dec 2002 | AU |
| 2005436 | Jun 1990 | CA |
| 26 40 413 | Mar 1978 | DE |
| 43 06 478 | Sep 1994 | DE |
| 29 504 378 | Sep 1995 | DE |
| 202018005662 | Feb 2019 | DE |
| 0100148 | Feb 1984 | EP |
| 0117632 | Sep 1984 | EP |
| 0161865 | Nov 1985 | EP |
| 0358302 | Mar 1990 | EP |
| 1018967 | Jul 2000 | EP |
| 1762205 | Mar 2007 | EP |
| 692578 | Jun 1953 | GB |
| 2195255 | Apr 1988 | GB |
| 2 197 789 | Jun 1988 | GB |
| 2 220 357 | Jan 1990 | GB |
| 2 235 877 | Mar 1991 | GB |
| 2 329 127 | Mar 1999 | GB |
| 2 333 965 | Aug 1999 | GB |
| 4129536 | Aug 2008 | JP |
| 71559 | Apr 2002 | SG |
| 8002182 | Oct 1980 | WO |
| 8704626 | Aug 1987 | WO |
| 90010424 | Sep 1990 | WO |
| 93009727 | May 1993 | WO |
| 9420041 | Sep 1994 | WO |
| 9605873 | Feb 1996 | WO |
| 9718007 | May 1997 | WO |
| 9913793 | Mar 1999 | WO |
| 2019027731 | Feb 2019 | WO |
| Entry |
|---|
| International Search Report and Written Opinion for corresponding Application No. PCT/IB2020/057197 mailed Oct. 16, 2020. |
| Louis C. Argenta, MD and Michael J. Morykwas, PhD; Vacuum-Assisted Closure: A New Method for Wound Control and Treatment: Clinical Experience; Annals of Plastic Surgery; vol. 38, No. 6, Jun. 1997; pp. 563-576. |
| Susan Mendez-Eatmen, RN; “When wounds Won't Heal” RN Jan. 1998, vol. 61 (1); Medical Economics Company, Inc., Montvale, NJ, USA; pp. 20-24. |
| James H. Blackburn II, MD et al.: Negative-Pressure Dressings as a Bolster for Skin Grafts; Annals of Plastic Surgery, vol. 40, No. 5, May 1998, pp. 453-457; Lippincott Williams & Wilkins, Inc., Philidelphia, PA, USA. |
| John Masters; “Reliable, Inexpensive and Simple Suction Dressings”; Letter to the Editor, British Journal of Plastic Surgery, 1998, vol. 51 (3), p. 267; Elsevier Science/The British Association of Plastic Surgeons, UK. |
| S.E. Greer, et al. “The Use of Subatmospheric Pressure Dressing Therapy to Close Lymphocutaneous Fistulas of the Groin” British Journal of Plastic Surgery (2000), 53, pp. 484-487. |
| George V. Letsou, MD., et al; “Stimulation of Adenylate Cyclase Activity in Cultured Endothelial Cells Subjected to Cyclic Stretch”; Journal of Cardiovascular Surgery, 31, 1990, pp. 634-639. |
| Orringer, Jay, et al; “Management of Wounds in Patients with Complex Enterocutaneous Fistulas”; Surgery, Gynecology & Obstetrics, Jul. 1987, vol. 165, pp. 79-80. |
| International Search Report for PCT International Application PCT/GB95/01983; Nov. 23, 1995. |
| PCT International Search Report for PCT International Application PCT/GB98/02713; Jan. 8, 1999. |
| PCT Written Opinion; PCT International Application PCT/GB98/02713; Jun. 8, 1999. |
| PCT International Examination and Search Report, PCT International Application PCT/GB96/02802; Jan. 15, 1998 & Apr. 29, 1997. |
| PCT Written Opinion, PCT International Application PCT/GB96/02802; Sep. 3, 1997. |
| Dattilo, Philip P., Jr., et al; “Medical Textiles: Application of an Absorbable Barbed Bi-directional Surgical Suture”; Journal of Textile and Apparel, Technology and Management, vol. 2, Issue 2, Spring 2002, pp. 1-5. |
| Kostyuchenok, B.M., et al; “Vacuum Treatment in the Surgical Management of Purulent Wounds”; Vestnik Khirurgi, Sep. 1986, pp. 18-21 and 6 page English translation thereof. |
| Davydov, Yu. A., et al; “Vacuum Therapy in the Treatment of Purulent Lactation Mastitis”; Vestnik Khirurgi, May 14, 1986, pp. 66-70, and 9 page English translation thereof. |
| Yusupov. Yu.N., et al; “Active Wound Drainage”, Vestnki Khirurgi, vol. 138, Issue 4, 1987, and 7 page English translation thereof. |
| Davydov, Yu.A., et al; “Bacteriological and Cytological Assessment of Vacuum Therapy for Purulent Wounds”; Vestnik Khirugi, Oct. 1988, pp. 48-52, and 8 page English translation thereof. |
| Davydov, Yu.A., et al; “Concepts for the Clinical-Biological Management of the Wound Process in the Treatment of Purulent Wounds by Means of Vacuum Therapy”; Vestnik Khirurgi, Jul. 7, 1980, pp. 132-136, and 8 page English translation thereof. |
| Chariker, Mark E., M.D., et al; “Effective Management of incisional and cutaneous fistulae with closed suction wound drainage”; Contemporary Surgery, vol. 34, Jun. 1989, pp. 59-63. |
| Egnell Minor, Instruction Book, First Edition, 300 7502, Feb. 1975, pp. 24. |
| Egnell Minor: Addition to the Users Manual Concerning Overflow Protection—Concerns all Egnell Pumps, Feb. 3, 1983, pp. 2. |
| Svedman, P.: “Irrigation Treatment of Leg Ulcers”, The Lancet, Sep. 3, 1983, pp. 532-534. |
| Chinn, Steven D. et al.: “Closed Wound Suction Drainage”, The Journal of Foot Surgery, vol. 24, No. 1, 1985, pp. 76-81. |
| Arnljots, Bjöm et al.: “Irrigation Treatment in Split-Thickness Skin Grafting of Intractable Leg Ulcers”, Scand J. Plast Reconstr. Surg., No. 19, 1985, pp. 211-213. |
| Svedman, P.: “A Dressing Allowing Continuous Treatment of a Biosurface”, IRCS Medical Science: Biomedical Technology, Clinical Medicine, Surgery and Transplantation, vol. 7, 1979, p. 221. |
| Svedman, P. et al: “A Dressing System Providing Fluid Supply and Suction Drainage Used for Continuous of Intermittent Irrigation”, Annals of Plastic Surgery, vol. 17, No. 2, Aug. 1986, pp. 125-133. |
| N.A. Bagautdinov, “Variant of External Vacuum Aspiration in the Treatment of Purulent Diseases of Soft Tissues,” Current Problems in Modern Clinical Surgery: Interdepartmental Collection, edited by V. Ye Volkov et al. (Chuvashia State University, Cheboksary, U.S.S.R. 1986); pp. 94-96 (certified translation). |
| K.F. Jeter, T.E. Tintle, and M. Chariker, “Managing Draining Wounds and Fistulae: New and Established Methods,” Chronic Wound Care, edited by D. Krasner (Health Management Publications, Inc., King of Prussia, PA 1990), pp. 240-246. |
| G. Živadinovi?, Ž. Maksimovi?, ?. Radak, and P. Pežka, “Vacuum Therapy in the Treatment of Peripheral Blood Vessels,” Timok Medical Journal 11 (1986), pp. 161-164 (certified translation). |
| F.E. Johnson, “An Improved Technique for Skin Graft Placement Using a Suction Drain,” Surgery, Gynecology, and Obstetrics 159 (1984), pp. 584-585. |
| A.A. Safronov, Dissertation Abstract, Vacuum Therapy of Trophic Ulcers of the Lower Leg with Simultaneous Autoplasty of the Skin (Central Scientific Research Institute of Traumatology and Orthopedics, Moscow, U.S.S.R. 1967) (certified translation). |
| M. Schein, R. Saadia, J.R. Jamieson, and G.A.G. Decker, “The ‘Sandwich Technique’ in the Management of the Open Abdomen,” British Journal of Surgery 73 (1986), pp. 369-370. |
| D.E. Tribble, An Improved Sump Drain-Irrigation Device of Simple Construction, Archives of Surgery 105 (1972) pp. 511-513. |
| M.J. Morykwas, L.C. Argenta, E.I. Shelton-Brown, and W. McGuirt, “Vacuum-Assisted Closure: A New Method for Wound Control and Treatment: Animal Studies and Basic Foundation,” Annals of Plastic Surgery 38 (1997), pp. 553-562 (Morykwas I). |
| C.E. Tennants, “The Use of Hypermia in the Postoperative Treatment of Lesions of the Extremities and Thorax,” Journal of the American Medical Association 64 (1915), pp. 1548-1549. |
| Selections from W. Meyer and V. Schmieden, Bier's Hyperemic Treatment in Surgery, Medicine, and the Specialties: A Manual of Its Practical Application, (W.B. Saunders Co., Philadelphia, PA 1909), pp. 17-25, 44-64, 90-96, 167-170, and 210-211. |
| V.A. Solovev et al., Guidelines, The Method of Treatment of Immature External Fistulas in the Upper Gastrointestinal Tract, editor-in-chief Prov. V.I. Parahonyak (S.M. Kirov Gorky State Medical Institute, Gorky, U.S.S.R. 1987) (“Solovev Guidelines”). |
| V.A. Kuznetsov & N.a. Bagautdinov, “Vacuum and Vacuum-Sorption Treatment of Open Septic Wounds,” in II All-Union Conference on Wounds and Wound Infections: Presentation Abstracts, edited by B.M. Kostyuchenok et al. (Moscow, U.S.S.R. Oct. 28-29, 1986) pp. 91-92 (“Bagautdinov II”). |
| V.A. Solovev, Dissertation Abstract, Treatment and Prevention of Suture Failures after Gastric Resection (S.M. Kirov Gorky State Medical Institute, Gorky, U.S.S.R. 1988) (“Solovev Abstract”). |
| V.A.C.® Therapy Clinical Guidelines: A Reference Source for Clinicians; Jul. 2007. |
| Number | Date | Country | |
|---|---|---|---|
| 20220265478 A1 | Aug 2022 | US |
| Number | Date | Country | |
|---|---|---|---|
| 62881591 | Aug 2019 | US |