Patent Description:
Embodiments described herein relate to apparatuses, systems, and methods the treatment of wounds, for example using dressings in combination with negative pressure wound therapy, particularly for post-breast surgery wounds.

The treatment of open or chronic wounds that are too large to spontaneously close or otherwise fail to heal by means of applying negative pressure to the site of the wound is well known in the art. Negative pressure wound therapy (NPWT) systems currently known in the art commonly involve placing a cover that is impermeable or semi-permeable to fluids over the wound, using various means to seal the cover to the tissue of the patient surrounding the wound, and connecting a source of negative pressure (such as a vacuum pump) to the cover in a manner so that negative pressure is created and maintained under the cover. It is believed that such negative pressures promote wound healing by facilitating the formation of granulation tissue at the wound site and assisting the body's normal inflammatory process while simultaneously removing excess fluid, which may contain adverse cytokines and/or bacteria. However, further improvements in NPWT are needed to fully realize the benefits of treatment.

Many different types of wound dressings are known for aiding in NPWT systems. These different types of wound dressings include many different types of materials and layers, for example, gauze, pads, foam pads or multi-layer wound dressings. One example of a multi-layer wound dressing is the PICO dressing, available from Smith & Nephew, which includes a superabsorbent layer beneath a backing layer to provide a canister-less system for treating a wound with NPWT. The wound dressing may be sealed to a suction port providing connection to a length of tubing, which may be used to pump fluid out of the dressing and/or to transmit negative pressure from a pump to the wound dressing.

Certain wounds have shapes that are difficult to treat with negative pressure wound therapy. It may be desirable, in some situations, to provide a wound dressing shaped to fit a specific region of the body or wound type so that it is shaped and contoured around that area allowing full coverage and even application of negative pressure throughout the treatment area. For example, it can be difficult to apply a standard wound dressing to post-breast surgery wounds. An example of a wound dressing according to the preamble of claim <NUM> can be seen in document <CIT>.

Embodiments of the present disclosure relate to apparatuses for wound treatment. Some of the wound treatment apparatuses described herein comprise a negative pressure source or a pump system for providing negative pressure to a wound. Wound treatment apparatuses may also comprise wound dressings that may be used in combination with the negative pressure sources and pump assemblies described herein. In some embodiments, one or more dressings can be used to treat one or more surgical wounds including post-breast surgery wounds.

The invention provides a negative pressure wound therapy apparatus, comprising:a wound dressing comprising an elongate portion having a longitudinal axis and a bridging portion, wherein the bridging portion comprises a first end and a second end, wherein the bridging portion extends away from a middle portion of the elongate portion at a substantially right angle from the longitudinal axis at the first end of the bridging portion, the wound dressing comprising within both the elongate portion and the bridging portion:a wound contact layer configured to be positioned in contact with a wound;an absorbent layer and/or transmission layer over the wound contact layer; and a cover layer configured to cover and form a seal over the wound contact layer and the absorbent layer and/or transmission layer, wherein the cover layer comprises an aperture at a second end of the bridging portion; and a fluidic connector positioned over the aperture in the cover layer at the second end of the bridging portion; and characterized in that the elongate portion is sized and configured to cover one or more post-surgical breast wounds, with the bridging portion being located between the breasts, the elongate portion comprising a first lobe on a first side of the bridging portion and a second lobe on a second side of the bridging portion and wherein the absorbent layer/and or transmission layer is a continuous layer between the bridging portion and the elongate portion and has a narrow portion that extends between the first and second lobes at the first end.

The apparatus of the preceding paragraph may also include any combination of the following features described in this paragraph, among others described herein. In some embodiments, the elongate portion is rectangular having a length parallel to the longitudinal axis and a width perpendicular to the longitudinal axis, wherein the length is greater than the width. According to the invention, the elongate portion comprises a first lobe on a first side of the bridging portion and a second lobe on a second side of the bridging portion. In some embodiments, the elongate portion comprises a bra shape. According to the invention, the absorbent layer/and or transmission layer is a continuous layer between the bridging portion and the elongate portion. In some embodiments, the bridging portion is rectangular. In some embodiments, the wound contact layer is a single sheet of material across the elongate portion and the bridging portion. In some embodiments, the cover layer is a single sheet of material across the elongate portion and the bridging portion. In some embodiments, elongate portion is sized and configured to cover one or more post-surgical breast wounds, with the bridging portion being located between the breasts.

In another aspect, a negative pressure wound therapy apparatus is disclosed, comprising: a wound dressing comprising an elongate portion comprising two lobes and a bridging portion, wherein the elongate portion comprises a longitudinal axis and the bridging portion is positioned in a middle portion of the elongate portion along the longitudinal axis, a first lobe on a first side of the bridging portion and a second lobe on a second side of the bridging portion, the wound dressing comprising within both the elongate portion and the bridging portion: a wound contact layer configured to be positioned in contact with a wound; an absorbent layer and/or transmission layer over the wound contact layer; and a cover layer configured to cover and form a seal over the wound contact layer and the absorbent layer and/or transmission layer, wherein the cover layer comprises an aperture in the bridging portion; and a fluidic connector positioned over the aperture in the cover layer at the bridging portion.

In some embodiments, the first and second lobes comprise a substantially triangular shape having edges and corners. In some embodiments, the first and second lobes comprise a long edge shared between the first triangular shaped lobe and the second triangular shaped lobe. In some embodiments, the first and second lobes comprise a substantially oval or circular shape. In some embodiments, the absorbent layer/and or transmission layer is a continuous layer between the bridging portion and the elongate portion. In some embodiments, the bridging portion is rectangular and extends perpendicularly away from the elongate portion. In some embodiments, the wound contact layer is a single sheet of material across the elongate portion and the bridging portion. In some embodiments, the cover layer is a single sheet of material across the elongate portion and the bridging portion. In some embodiments, the one or more lobes are sized and configured to cover one or more post-surgical breast wounds, with the bridging portion being located between the breasts.

In another aspect, a negative pressure wound therapy apparatus is disclosed, comprising: a wound dressing comprising an elongate portion having a longitudinal axis and a bridging portion, wherein the bridging portion comprises a first end and a second end, wherein the bridging portion extends away from a middle portion of the elongate portion at a substantially right angle from the longitudinal axis at the first end of the bridging portion, the wound dressing comprising within both the elongate portion and the bridging portion: a wound contact layer configured to be positioned in contact with a wound; an absorbent layer and/or transmission layer over the wound contact layer; and a cover layer configured to cover and form a seal over the wound contact layer and the absorbent layer and/or transmission layer, wherein the cover layer comprises an aperture at a second end of the bridging portion; and a fluidic connector positioned over the aperture in the cover layer at the second end of the bridging portion; wherein the elongate portion and the bridging portion are sized and configured to cover one or more post-surgical breast wounds, with the elongate portion and the bridging portion sized and configured to be located on a single breast.

In some embodiments, the elongate portion is rectangular having a length parallel to the longitudinal axis and a width perpendicular to the longitudinal axis, wherein the length is greater than the width. In some embodiments, the absorbent layer/and or transmission layer is a continuous layer between the bridging portion and the elongate portion. In some embodiments, the bridging portion is rectangular. In some embodiments, the wound contact layer is a single sheet of material across the elongate portion and the bridging portion. In some embodiments, the cover layer is a single sheet of material across the elongate portion and the bridging portion. In some embodiments, the wound dressing is a first wound dressing and the fluid connector is a first fluid connector, and further comprises a second wound dressing comprising an elongate portion having a longitudinal axis and a bridging portion, wherein the bridging portion comprises a first end and a second end, wherein the bridging portion extends away from a middle portion of the elongate portion at a substantially right angle from the longitudinal axis at the first end of the bridging portion, the second wound dressing comprising within both the elongate portion and the bridging portion: a wound contact layer configured to be positioned in contact with a wound; an absorbent layer and/or transmission layer over the wound contact layer; and a cover layer configured to cover and form a seal over the wound contact layer and the absorbent layer and/or transmission layer, wherein the cover layer comprises an aperture at a second end of the bridging portion; and a second fluidic connector positioned over the aperture in the cover layer of the second wound dressing at the second end of the bridging portion of the second wound dressing; wherein the elongate portion and the bridging portion of the second wound dressing are sized and configured to cover one or more post-surgical breast wounds, with the elongate portion and the bridging portion of the second wound dressing sized and configured to be located on a different breast than that of the first wound dressing. In some embodiments, the first fluidic connector and the second fluidic connector are configured to be connected to a single negative pressure source via a Y-shaped connector.

In another aspect, a negative pressure wound therapy apparatus is disclosed, comprising: a wound dressing comprising a triangular shape, the wound dressing having three edges and three corners, the wound dressing comprising: a wound contact layer configured to be positioned in contact with a wound; an absorbent layer and/or transmission layer over the wound contact layer; and a cover layer configured to cover and form a seal over the wound contact layer and the absorbent layer and/or transmission layer, wherein the cover layer comprises an aperture positioned near an edge of the triangular shaped dressing; and a fluidic connector positioned over the aperture in the cover layer near the edge of the triangular shaped dressing.

In some embodiments, the wound dressing is sized and configured to cover one or more post-surgical breast wounds, wherein the dressing is configured to cover a single breast. In some embodiments, the wound dressing is a first wound dressing and the fluidic connector is a first fluid connector, and further comprises a second wound dressing comprising a triangular shape, the second wound dressing having three edges and three corners, the second wound dressing comprising: a wound contact layer configured to be positioned in contact with a wound; an absorbent layer and/or transmission layer over the wound contact layer; and a cover layer configured to cover and form a seal over the wound contact layer and the absorbent layer and/or transmission layer, wherein the cover layer comprises an aperture positioned near an edge of the triangular shaped dressing; and a second fluidic connector positioned over the aperture in the cover layer of the second wound dressing near the edge of the second triangular shaped dressing. In some embodiments, the second wound dressing is sized and configured to cover one or more post-surgical breast wounds, wherein the second dressing is configured to cover a different breast than that of the first wound dressing. In some embodiments, the first fluidic connector and the second fluidic connector are configured to be connected to a single negative pressure source via a Y-shaped connector.

In other aspects, a negative pressure wound therapy apparatus is disclosed which comprises a first wound dressing and a second wound dressing, each wound dressing sized and configured to be located on different breasts. In some embodiments, the apparatus comprises a Y-shaped connector configured to connect to the first and second wound dressings, for example via first and second fluidic connectors positioned in fluid communication with the first and second wound dressings, respectively. A single negative pressure source may be provided to connect to the Y-shaped connector to provide negative pressure simultaneously to both the first and second wound dressings.

In some embodiments, each of the first and second wound dressings may comprise an elongate portion having a longitudinal axis and a bridging portion, wherein the bridging portion comprises a first end and a second end, wherein the bridging portion extends away from a middle portion of the elongate portion at a substantially right angle from the longitudinal axis at the first end of the bridging portion. Each of the first and second wound dressings may comprise within the elongate portion and the bridging portion: a wound contact layer configured to be positioned in contact with a wound; an absorbent layer and/or transmission layer over the wound contact layer; and a cover layer configured to cover and form a seal over the wound contact layer and the absorbent layer and/or transmission layer, wherein the cover layer comprises an aperture at a second end of the bridging portion. First and second fluidic connectors may be positioned over the aperture in the cover layer of the first and second wound dressings, respectively, at the second end of the bridging portion. The elongate portion and the bridging portion of each of the first and second wound dressings may be sized and configured to cover one or more post-surgical breast wounds of different breasts.

Embodiments disclosed herein relate to apparatuses for treating a wound with reduced pressure, including a source of negative pressure and wound dressing components and apparatuses. The apparatuses and components comprising the wound overlay and packing materials, if any, are sometimes collectively referred to herein as dressings.

Preferred embodiments disclosed herein relate to wound therapy for a human or animal body. Therefore, any reference to a wound herein can refer to a wound on a human or animal body, and any reference to a body herein can refer to a human or animal body. The term "wound" as used herein, in addition to having its broad ordinary meaning, includes any body part of a patient that may be treated using negative pressure. It is to be understood that the term wound is to be broadly construed and encompasses open and closed wounds in which skin is torn, cut or punctured or where trauma causes a contusion, or any other superficial or other conditions or imperfections on the skin of a patient or otherwise that benefit from reduced pressure treatment. A wound is thus broadly defined as any damaged region of tissue where fluid may or may not be produced. Examples of such wounds include, but are not limited to, abdominal wounds or other large or incisional wounds, either as a result of surgery, trauma, sterniotomies, fasciotomies, or other conditions, dehisced wounds, acute wounds, chronic wounds, subacute and dehisced wounds, traumatic wounds, flaps and skin grafts, lacerations, abrasions, contusions, bums, diabetic ulcers, pressure ulcers, stoma, surgical wounds, trauma and venous ulcers or the like.

Treatment of such wounds can be performed using negative pressure wound therapy, wherein a reduced or negative pressure can be applied to the wound to facilitate and promote healing of the wound. It will also be appreciated that the wound dressing and methods as disclosed herein may be applied to other parts of the body, and are not necessarily limited to treatment of wounds.

It will be understood that embodiments of the present disclosure are generally applicable to use in topical negative pressure ("TNP") therapy systems. Briefly, negative pressure wound therapy assists in the closure and healing of many forms of "hard to heal" wounds by reducing tissue oedema; encouraging blood flow and granular tissue formation; removing excess exudate and may reduce bacterial load (and thus infection risk). In addition, the therapy allows for less disturbance of a wound leading to more rapid healing. TNP therapy systems may also assist on the healing of surgically closed wounds by removing fluid and by helping to stabilize the tissue in the apposed position of closure. A further beneficial use of TNP therapy can be found in grafts and flaps where removal of excess fluid is important and close proximity of the graft to tissue is required in order to ensure tissue viability.

As is used herein, reduced or negative pressure levels, such as -X mmHg, represent pressure levels relative to normal ambient atmospheric pressure, which can correspond to <NUM> mmHg (or <NUM> atm, <NUM> inHg, <NUM> kPa, <NUM> psi, etc.). Accordingly, a negative pressure value of -X mmHg reflects absolute pressure that is X mmHg below <NUM> mmHg or, in other words, an absolute pressure of (<NUM>-X) mmHg. In addition, negative pressure that is "less" or "smaller" than X mmHg corresponds to pressure that is closer to atmospheric pressure (e.g.,-<NUM> mmHg is less than -<NUM> mmHg). Negative pressure that is "more" or "greater" than -X mmHg corresponds to pressure that is further from atmospheric pressure (e.g., -<NUM> mmHg is more than -<NUM> mmHg). In some embodiments, local ambient atmospheric pressure is used as a reference point, and such local atmospheric pressure may not necessarily be, for example, <NUM> mmHg.

The negative pressure range for some embodiments of the present disclosure can be approximately -<NUM> mmHg, or between about -<NUM> mmHg and -<NUM> mmHg. Note that these pressures are relative to normal ambient atmospheric pressure, which can be <NUM> mmHg. Thus, -<NUM> mmHg would be about <NUM> mmHg in practical terms. In some embodiments, the pressure range can be between about -<NUM> mmHg and -<NUM> mmHg. Alternatively a pressure range of up to -<NUM> mmHg, up to -<NUM> mmHg or over -<NUM> mmHg can be used. Also in other embodiments a pressure range of below -<NUM> mmHg can be used. Alternatively, a pressure range of over approximately -<NUM> mmHg, or even -<NUM> mmHg, can be supplied by the negative pressure apparatus.

In some embodiments of wound closure devices described herein, increased wound contraction can lead to increased tissue expansion in the surrounding wound tissue. This effect may be increased by varying the force applied to the tissue, for example by varying the negative pressure applied to the wound over time, possibly in conjunction with increased tensile forces applied to the wound via embodiments of the wound closure devices. In some embodiments, negative pressure may be varied over time for example using a sinusoidal wave, square wave, and/or in synchronization with one or more patient physiological indices (e.g., heartbeat). Examples of such applications where additional disclosure relating to the preceding may be found include <CIT>; and <CIT>.

Embodiments of the wound dressings, wound dressing components, wound treatment apparatuses and methods described herein may also be used in combination or in addition to those described in International Application No. <CIT>, published as <CIT>, titled "APPARATUSES AND METHODS FOR NEGATIVE PRESSURE WOUND THERAPY," <CIT>, published as <CIT>, titled "WOUND DRESSING AND METHOD OF TREATMENT,". Embodiments of the wound dressings, wound treatment apparatuses and methods described herein may also be used in combination or in addition to those described in <CIT>, published as <CIT>, titled "WOUND DRESSING AND METHOD OF USE," and <CIT>, titled "FLUIDIC CONNECTOR FOR NEGATIVE PRESSURE WOUND THERAPY,".

Additionally, some embodiments related to TNP wound treatment comprising a wound dressing in combination with a pump and/or associated electronics described herein may also be used in combination or in addition to those described in PCT Application No. <CIT>, entitled "REDUCED PRESSURE APPARATUS AND METHODS".

<FIG> illustrate embodiments of a negative pressure wound treatment system <NUM> employing a wound dressing <NUM> in conjunction with a fluidic connector <NUM>. Here, the fluidic connector <NUM> may comprise an elongate conduit, more preferably a bridge <NUM> having a proximal end <NUM> and a distal end <NUM>, and an applicator <NUM> at the distal end <NUM> of the bridge <NUM>. An optional coupling <NUM> is preferably disposed at the proximal end <NUM> of the bridge <NUM>. A cap <NUM> may be provided with the system (and can in some cases, as illustrated, be attached to the coupling <NUM>). The cap <NUM> can be useful in preventing fluids from leaking out of the proximal end <NUM>. The system <NUM> may include a source of negative pressure such as a pump or negative pressure unit <NUM> capable of supplying negative pressure. The pump may comprise a canister or other container for the storage of wound exudates and other fluids that may be removed from the wound. A canister or container may also be provided separate from the pump. In some embodiments, such as illustrated in <FIG>, the pump <NUM> can be a canisterless pump such as the PICO™ pump, as sold by Smith & Nephew. The pump <NUM> may be connected to the coupling <NUM> via a tube <NUM>, or the pump <NUM> may be connected directly to the coupling <NUM> or directly to the bridge <NUM>. In use, the dressing <NUM> is placed over a suitably-prepared wound, which may in some cases be filled with a wound packing material such as foam or gauze. The applicator <NUM> of the fluidic connector <NUM> has a sealing surface that is placed over an aperture in the dressing <NUM> and is sealed to the top surface of the dressing <NUM>. In other embodiments, the fluidic connector <NUM> that is positioned over the aperture in the dressing can also include a fluidic connector <NUM> that has a portion of the fluidic connector <NUM> positioned on the underside of the top layer or cover layer of the dressing. In some embodiments, the fluidic connector can include a flange that can be attached to the underside or top surface of the cover layer. Either before, during, or after connection of the fluidic connector <NUM> to the dressing <NUM>, the pump <NUM> is connected via the tube <NUM> to the coupling <NUM>, or is connected directly to the coupling <NUM> or to the bridge <NUM>. The pump is then activated, thereby supplying negative pressure to the wound. Application of negative pressure may be applied until a desired level of healing of the wound is achieved.

As shown in <FIG>, the fluidic connector <NUM> preferably comprises an enlarged distal end, or head <NUM> that is in fluidic communication with the dressing <NUM> as will be described in further detail below. In one embodiment, the enlarged distal end has a round or circular shape. The head <NUM> is illustrated here as being positioned near an edge of the dressing <NUM>, but may also be positioned at any location on the dressing. For example, some embodiments may provide for a centrally or off-centered location not on or near an edge or corner of the dressing <NUM>. In some embodiments, the dressing <NUM> may comprise two or more fluidic connectors <NUM>, each comprising one or more heads <NUM>, in fluidic communication therewith. In a preferred embodiment, the head <NUM> may measure <NUM> along its widest edge. The head <NUM> forms at least in part the applicator <NUM>, described above, that is configured to seal against a top surface of the wound dressing.

<FIG> illustrates a cross-section through a wound dressing <NUM> similar to the wound dressing <NUM> as shown in <FIG> and described in International Patent Publication <CIT>, along with fluidic connector <NUM>. The wound dressing <NUM>, which can alternatively be any wound dressing embodiment disclosed herein or any combination of features of any number of wound dressing embodiments disclosed herein, can be located over a wound site to be treated. The dressing <NUM> may be placed as to form a sealed cavity over the wound site. In a preferred embodiment, the dressing <NUM> comprises a top or cover layer, or backing layer <NUM> attached to an optional wound contact layer <NUM>, both of which are described in greater detail below. These two layers <NUM>, <NUM> are preferably joined or sealed together so as to define an interior space or chamber. This interior space or chamber may comprise additional structures that may be adapted to distribute or transmit negative pressure, store wound exudate and other fluids removed from the wound, and other functions which will be explained in greater detail below. Examples of such structures, described below, include a transmission layer <NUM> and an absorbent layer <NUM>.

As used herein the upper layer, top layer, or layer above refers to a layer furthest from the surface of the skin or wound while the dressing is in use and positioned over the wound. Accordingly, the lower surface, lower layer, bottom layer, or layer below refers to the layer that is closest to the surface of the skin or wound while the dressing is in use and positioned over the wound.

As illustrated in <FIG>, the wound contact layer <NUM> can be a polyurethane layer or polyethylene layer or other flexible layer which is perforated, for example via a hot pin process, laser ablation process, ultrasound process or in some other way or otherwise made permeable to liquid and gas. The wound contact layer <NUM> has a lower surface <NUM> and an upper surface <NUM>. The perforations <NUM> preferably comprise through holes in the wound contact layer <NUM> which enable fluid to flow through the layer <NUM>. The wound contact layer <NUM> helps prevent tissue ingrowth into the other material of the wound dressing. Preferably, the perforations are small enough to meet this requirement while still allowing fluid to flow therethrough. For example, perforations formed as slits or holes having a size ranging from <NUM> to <NUM> are considered small enough to help prevent tissue ingrowth into the wound dressing while allowing wound exudate to flow into the dressing. In some configurations, the wound contact layer <NUM> may help maintain the integrity of the entire dressing <NUM> while also creating an air tight seal around the absorbent pad in order to maintain negative pressure at the wound.

Some embodiments of the wound contact layer <NUM> may also act as a carrier for an optional lower and upper adhesive layer (not shown). For example, a lower pressure sensitive adhesive may be provided on the lower surface <NUM> of the wound dressing <NUM> whilst an upper pressure sensitive adhesive layer may be provided on the upper surface <NUM> of the wound contact layer. The pressure sensitive adhesive, which may be a silicone, hot melt, hydrocolloid or acrylic based adhesive or other such adhesives, may be formed on both sides or optionally on a selected one or none of the sides of the wound contact layer. When a lower pressure sensitive adhesive layer is utilized may be helpful to adhere the wound dressing <NUM> to the skin around a wound site. In some embodiments, the wound contact layer may comprise perforated polyurethane film. The lower surface of the film may be provided with a silicone pressure sensitive adhesive and the upper surface may be provided with an acrylic pressure sensitive adhesive, which may help the dressing maintain its integrity. In some embodiments, a polyurethane film layer may be provided with an adhesive layer on both its upper surface and lower surface, and all three layers may be perforated together.

A layer <NUM> of porous material can be located above the wound contact layer <NUM>. This porous layer, or transmission layer, <NUM> allows transmission of fluid including liquid and gas away from a wound site into upper layers of the wound dressing. In particular, the transmission layer <NUM> preferably ensures that an open air channel can be maintained to communicate negative pressure over the wound area even when the absorbent layer has absorbed substantial amounts of exudates. The layer <NUM> should preferably remain open under the typical pressures that will be applied during negative pressure wound therapy as described above, so that the whole wound site sees an equalized negative pressure. The layer <NUM> may be formed of a material having a three dimensional structure. For example, a knitted or woven spacer fabric (for example Baltex <NUM> weft knitted polyester) or a non-woven fabric could be used.

In some embodiments, the transmission layer <NUM> comprises a 3D polyester spacer fabric layer including a top layer (that is to say, a layer distal from the wound-bed in use) which is a <NUM>/<NUM> textured polyester, and a bottom layer (that is to say, a layer which lies proximate to the wound bed in use) which is a <NUM> denier flat polyester and a third layer formed sandwiched between these two layers which is a region defined by a knitted polyester viscose, cellulose or the like monofilament fiber. Other materials and other linear mass densities of fiber could of course be used.

Whilst reference is made throughout this disclosure to a monofilament fiber it will be appreciated that a multistrand alternative could of course be utilized. The top spacer fabric thus has more filaments in a yarn used to form it than the number of filaments making up the yarn used to form the bottom spacer fabric layer.

This differential between filament counts in the spaced apart layers helps control moisture flow across the transmission layer. Particularly, by having a filament count greater in the top layer, that is to say, the top layer is made from a yarn having more filaments than the yarn used in the bottom layer, liquid tends to be wicked along the top layer more than the bottom layer. In use, this differential tends to draw liquid away from the wound bed and into a central region of the dressing where the absorbent layer <NUM> helps lock the liquid away or itself wicks the liquid onwards towards the cover layer where it can be transpired.

Preferably, to improve the liquid flow across the transmission layer <NUM> (that is to say perpendicular to the channel region formed between the top and bottom spacer layers, the 3D fabric may be treated with a dry cleaning agent (such as, but not limited to, Perchloro Ethylene) to help remove any manufacturing products such as mineral oils, fats and/or waxes used previously which might interfere with the hydrophilic capabilities of the transmission layer. In some embodiments, an additional manufacturing step can subsequently be carried in which the 3D spacer fabric is washed in a hydrophilic agent (such as, but not limited to, Feran Ice <NUM>/l available from the Rudolph Group). This process step helps ensure that the surface tension on the materials is so low that liquid such as water can enter the fabric as soon as it contacts the 3D knit fabric. This also aids in controlling the flow of the liquid insult component of any exudates.

A layer <NUM> of absorbent material is provided above the transmission layer <NUM>. The absorbent material, which comprise a foam or non-woven natural or synthetic material, and which may optionally comprise a super-absorbent material, forms a reservoir for fluid, particularly liquid, removed from the wound site. In some embodiments, the layer <NUM> may also aid in drawing fluids towards the backing layer <NUM>.

The material of the absorbent layer <NUM> may also prevent liquid collected in the wound dressing <NUM> from flowing freely within the dressing, and preferably acts so as to contain any liquid collected within the dressing. The absorbent layer <NUM> also helps distribute fluid throughout the layer via a wicking action so that fluid is drawn from the wound site and stored throughout the absorbent layer. This helps prevent agglomeration in areas of the absorbent layer. The capacity of the absorbent material must be sufficient to manage the exudates flow rate of a wound when negative pressure is applied. Since in use the absorbent layer experiences negative pressures the material of the absorbent layer is chosen to absorb liquid under such circumstances. A number of materials exist that are able to absorb liquid when under negative pressure, for example superabsorber material. The absorbent layer <NUM> may typically be manufactured from ALLEVYN™ foam, Freudenberg <NUM>-<NUM>-<NUM> and/or Chem-Posite™11C-<NUM>. In some embodiments, the absorbent layer <NUM> may comprise a composite comprising superabsorbent powder, fibrous material such as cellulose, and bonding fibers. In a preferred embodiment, the composite is an airlaid, thermally-bonded composite.

An aperture, hole, or orifice <NUM> is preferably provided in the backing layer <NUM> to allow a negative pressure to be applied to the dressing <NUM>. The fluidic connector <NUM> is preferably attached or sealed to the top of the backing layer <NUM> over the orifice <NUM> made into the dressing <NUM>, and communicates negative pressure through the orifice <NUM>. A length of tubing may be coupled at a first end to the fluidic connector <NUM> and at a second end to a pump unit (not shown) to allow fluids to be pumped out of the dressing. Where the fluidic connector is adhered to the top layer of the wound dressing, a length of tubing may be coupled at a first end of the fluidic connector such that the tubing, or conduit, extends away from the fluidic connector parallel or substantially to the top surface of the dressing. The fluidic connector <NUM> may be adhered and sealed to the backing layer <NUM> using an adhesive such as an acrylic, cyanoacrylate, epoxy, UV curable or hot melt adhesive. The fluidic connector <NUM> may be formed from a soft polymer, for example a polyethylene, a polyvinyl chloride, a silicone or polyurethane having a hardness of <NUM> to <NUM> on the Shore A scale. In some embodiments, the fluidic connector <NUM> may be made from a soft or conformable material.

Preferably the absorbent layer <NUM> includes at least one through hole <NUM> located so as to underlie the fluidic connector <NUM>. The through hole <NUM> may in some embodiments be the same size as the opening <NUM> in the backing layer, or may be bigger or smaller. As illustrated in <FIG> a single through hole can be used to produce an opening underlying the fluidic connector <NUM>. It will be appreciated that multiple openings could alternatively be utilized. Additionally, should more than one port be utilized according to certain embodiments of the present disclosure one or multiple openings may be made in the absorbent layer and the obscuring layer in registration with each respective fluidic connector. Although not essential to certain embodiments of the present disclosure the use of through holes in the super-absorbent layer may provide a fluid flow pathway which remains unblocked in particular when the absorbent layer is near saturation.

The aperture or through-hole <NUM> is preferably provided in the absorbent layer <NUM> beneath the orifice <NUM> such that the orifice is connected directly to the transmission layer <NUM> as illustrated in <FIG>. This allows the negative pressure applied to the fluidic connector <NUM> to be communicated to the transmission layer <NUM> without passing through the absorbent layer <NUM>. This ensures that the negative pressure applied to the wound site is not inhibited by the absorbent layer as it absorbs wound exudates. In other embodiments, no aperture may be provided in the absorbent layer <NUM>, or alternatively a plurality of apertures underlying the orifice <NUM> may be provided. In further alternative embodiments, additional layers such as another transmission layer or an obscuring layer such as described in International Patent Publication <CIT> may be provided over the absorbent layer <NUM> and beneath the backing layer <NUM>.

The backing layer <NUM> is preferably gas impermeable, but moisture vapor permeable, and can extend across the width of the wound dressing <NUM>. The backing layer <NUM>, which may for example be a polyurethane film (for example, Elastollan SP9109) having a pressure sensitive adhesive on one side, is impermeable to gas and this layer thus operates to cover the wound and to seal a wound cavity over which the wound dressing is placed. In this way an effective chamber is made between the backing layer <NUM> and a wound site where a negative pressure can be established. The backing layer <NUM> is preferably sealed to the wound contact layer <NUM> in a border region around the circumference of the dressing, ensuring that no air is drawn in through the border area, for example via adhesive or welding techniques. The backing layer <NUM> protects the wound from external bacterial contamination (bacterial barrier) and allows liquid from wound exudates to be transferred through the layer and evaporated from the film outer surface. The backing layer <NUM> preferably comprises two layers; a polyurethane film and an adhesive pattern spread onto the film. The polyurethane film is preferably moisture vapor permeable and may be manufactured from a material that has an increased water transmission rate when wet. In some embodiments the moisture vapor permeability of the backing layer increases when the backing layer becomes wet. The moisture vapor permeability of the wet backing layer may be up to about ten times more than the moisture vapor permeability of the dry backing layer.

The absorbent layer <NUM> may be of a greater area than the transmission layer <NUM>, such that the absorbent layer overlaps the edges of the transmission layer <NUM>, thereby ensuring that the transmission layer does not contact the backing layer <NUM>. This provides an outer channel of the absorbent layer <NUM> that is in direct contact with the wound contact layer <NUM>, which aids more rapid absorption of exudates to the absorbent layer. Furthermore, this outer channel ensures that no liquid is able to pool around the circumference of the wound cavity, which may otherwise seep through the seal around the perimeter of the dressing leading to the formation of leaks. As illustrated in <FIG>, the absorbent layer <NUM> may define a smaller perimeter than that of the backing layer <NUM>, such that a boundary or border region is defined between the edge of the absorbent layer <NUM> and the edge of the backing layer <NUM>.

As shown in <FIG>, one embodiment of the wound dressing <NUM> comprises an aperture <NUM> in the absorbent layer <NUM> situated underneath the fluidic connector <NUM>. In use, for example when negative pressure is applied to the dressing <NUM>, a wound facing portion of the fluidic connector may thus come into contact with the transmission layer <NUM>, which can thus aid in transmitting negative pressure to the wound site even when the absorbent layer <NUM> is filled with wound fluids. Some embodiments may have the backing layer <NUM> be at least partly adhered to the transmission layer <NUM>. In some embodiments, the aperture <NUM> is at least <NUM>-<NUM> larger than the diameter of the wound facing portion of the fluidic connector <NUM>, or the orifice <NUM>.

In particular for embodiments with a single fluidic connector <NUM> and through hole, it may be preferable for the fluidic connector <NUM> and through hole to be located in an off-center position as illustrated in <FIG>. Such a location may permit the dressing <NUM> to be positioned onto a patient such that the fluidic connector <NUM> is raised in relation to the remainder of the dressing <NUM>. So positioned, the fluidic connector <NUM> and the filter <NUM> may be less likely to come into contact with wound fluids that could prematurely occlude the filter <NUM> so as to impair the transmission of negative pressure to the wound site.

Turning now to the fluidic connector <NUM>, preferred embodiments comprise a sealing surface <NUM>, a bridge <NUM> (corresponding to bridge <NUM> in <FIG>) with a proximal end <NUM> and a distal end <NUM>, and a filter <NUM>. The sealing surface <NUM> preferably forms the applicator previously described that is sealed to the top surface of the wound dressing. In some embodiments a bottom layer of the fluidic connector <NUM> may comprise the sealing surface <NUM>. The fluidic connector <NUM> may further comprise an upper surface vertically spaced from the sealing surface <NUM>, which in some embodiments is defined by a separate upper layer of the fluidic connector. In other embodiments the upper surface and the lower surface may be formed from the same piece of material. In some embodiments the sealing surface <NUM> may comprise at least one aperture <NUM> therein to communicate with the wound dressing. In some embodiments the filter <NUM> may be positioned across the opening <NUM> in the sealing surface, and may span the entire opening <NUM>. The sealing surface <NUM> may be configured for sealing the fluidic connector to the cover layer of the wound dressing, and may comprise an adhesive or weld. In some embodiments, the sealing surface <NUM> may be placed over an orifice in the cover layer with optional spacer elements <NUM> configured to create a gap between the filter <NUM> and the transmission layer <NUM>. In other embodiments, the sealing surface <NUM> may be positioned over an orifice in the cover layer and an aperture in the absorbent layer <NUM>, permitting the fluidic connector <NUM> to provide air flow through the transmission layer <NUM>. In some embodiments, the bridge <NUM> may comprise a first fluid passage <NUM> in communication with a source of negative pressure, the first fluid passage <NUM> comprising a porous material, such as a 3D knitted material, which may be the same or different than the porous layer <NUM> described previously. The bridge <NUM> is preferably encapsulated by at least one flexible film layer <NUM>, <NUM> having a proximal and distal end and configured to surround the first fluid passage <NUM>, the distal end of the flexible film being connected the sealing surface <NUM>. The filter <NUM> is configured to substantially prevent wound exudate from entering the bridge, and spacer elements <NUM> are configured to prevent the fluidic connector from contacting the transmission layer <NUM>. These elements will be described in greater detail below.

Some embodiments may further comprise an optional second fluid passage positioned above the first fluid passage <NUM>. For example, some embodiments may provide for an air leak may be disposed at the proximal end of the top layer that is configured to provide an air path into the first fluid passage <NUM> and dressing <NUM> similar to the suction adapter as described in <CIT>.

Preferably, the fluid passage <NUM> is constructed from a compliant material that is flexible and that also permits fluid to pass through it if the spacer is kinked or folded over. Suitable materials for the fluid passage <NUM> include without limitation foams, including open-cell foams such as polyethylene or polyurethane foam, meshes, 3D knitted fabrics, non-woven materials, and fluid channels. In some embodiments, the fluid passage <NUM> may be constructed from materials similar to those described above in relation to the transmission layer <NUM>. Advantageously, such materials used in the fluid passage <NUM> not only permit greater patient comfort, but may also provide greater kink resistance, such that the fluid passage <NUM> is still able to transfer fluid from the wound toward the source of negative pressure while being kinked or bent.

In some embodiments, the fluid passage <NUM> may be comprised of a wicking fabric, for example a knitted or woven spacer fabric (such as a knitted polyester 3D fabric, Baltex <NUM>®, or Gehring <NUM>®) or a nonwoven fabric. These materials selected are preferably suited to channeling wound exudate away from the wound and for transmitting negative pressure and/or vented air to the wound site, and may also confer a degree of kinking or occlusion resistance to the fluid passage <NUM>. In some embodiments, the wicking fabric may have a three-dimensional structure, which in some cases may aid in wicking fluid or transmitting negative pressure. In certain embodiments, including wicking fabrics, these materials remain open and capable of communicating negative pressure to a wound area under the typical pressures used in negative pressure therapy, for example between <NUM> to <NUM> mmHg. In some embodiments, the wicking fabric may comprise several layers of material stacked or layered over each other, which may in some cases be useful in preventing the fluid passage <NUM> from collapsing under the application of negative pressure. In other embodiments, the wicking fabric used in the fluid passage <NUM> may be between <NUM> and <NUM>; more preferably, the wicking fabric may be between <NUM> and <NUM> thick, and may be comprised of either one or several individual layers of wicking fabric. In other embodiments, the fluid passage <NUM> may be between <NUM>-<NUM> thick, and preferably thicker than <NUM>. Some embodiments, for example a suction adapter used with a dressing which retains liquid such as wound exudate, may employ hydrophobic layers in the fluid passage <NUM>, and only gases may travel through the fluid passage <NUM>. Additionally, and as described previously, the materials used in the system are preferably conformable and soft, which may help to avoid pressure ulcers and other complications which may result from a wound treatment system being pressed against the skin of a patient.

Preferably, the filter element <NUM> is impermeable to liquids, but permeable to gases, and is provided to act as a liquid barrier and to ensure that no liquids are able to escape from the wound dressing <NUM>. The filter element <NUM> may also function as a bacterial barrier. Typically the pore size is <NUM>. Suitable materials for the filter material of the filter element <NUM> include <NUM> micron Gore™ expanded PTFE from the MMT range, PALL Versapore™ 200R, and Donaldson™ TX6628. Larger pore sizes can also be used but these may require a secondary filter layer to ensure full bioburden containment. As wound fluid contains lipids it is preferable, though not essential, to use an oleophobic filter membrane for example <NUM> micron MMT-<NUM> prior to <NUM> micron MMT-<NUM>. This prevents the lipids from blocking the hydrophobic filter. The filter element can be attached or sealed to the port and/or the cover film over the orifice. For example, the filter element <NUM> may be molded into the fluidic connector <NUM>, or may be adhered to one or both of the top of the cover layer and bottom of the suction adapter <NUM> using an adhesive such as, but not limited to, a UV cured adhesive.

It will be understood that other types of material could be used for the filter element <NUM>. More generally a microporous membrane can be used which is a thin, flat sheet of polymeric material, this contains billions of microscopic pores. Depending upon the membrane chosen these pores can range in size from <NUM> to more than <NUM> micrometers. Microporous membranes are available in both hydrophilic (water filtering) and hydrophobic (water repellent) forms. In some embodiments of the invention, filter element <NUM> comprises a support layer and an acrylic co-polymer membrane formed on the support layer. Preferably the wound dressing <NUM> according to certain embodiments of the present invention uses microporous hydrophobic membranes (MHMs). Numerous polymers may be employed to form MHMs. For example, the MHMs may be formed from one or more of PTFE, polypropylene, PVDF and acrylic copolymer. All of these optional polymers can be treated in order to obtain specific surface characteristics that can be both hydrophobic and oleophobic. As such these will repel liquids with low surface tensions such as multi-vitamin infusions, lipids, surfactants, oils and organic solvents.

MHMs block liquids whilst allowing air to flow through the membranes. They are also highly efficient air filters eliminating potentially infectious aerosols and particles. A single piece of MHM is well known as an option to replace mechanical valves or vents. Incorporation of MHMs can thus reduce product assembly costs improving profits and costs/benefit ratio to a patient.

The filter element <NUM> may also include an odor absorbent material, for example activated charcoal, carbon fiber cloth or Vitec Carbotec-RT Q2003073 foam, or the like. For example, an odor absorbent material may form a layer of the filter element <NUM> or may be sandwiched between microporous hydrophobic membranes within the filter element. The filter element <NUM> thus enables gas to be exhausted through the orifice. Liquid, particulates and pathogens however are contained in the dressing.

The wound dressing <NUM> may comprise spacer elements <NUM> in conjunction with the fluidic connector <NUM> and the filter <NUM>. With the addition of such spacer elements <NUM> the fluidic connector <NUM> and filter <NUM> may be supported out of direct contact with the absorbent layer <NUM> and/or the transmission layer <NUM>. The absorbent layer <NUM> may also act as an additional spacer element to keep the filter <NUM> from contacting the transmission layer <NUM>. Accordingly, with such a configuration contact of the filter <NUM> with the transmission layer <NUM> and wound fluids during use may thus be minimized.

Similar to the embodiments of wound dressings described above, some wound dressings comprise a perforated wound contact layer with silicone adhesive on the skin-contact face and acrylic adhesive on the reverse. Above this bordered layer sits a transmission layer or a 3D spacer fabric pad. Above the transmission layer, sits an absorbent layer. The absorbent layer can include a superabsorbent non-woven (NW) pad. The absorbent layer can over-border the transmission layer by approximately <NUM> at the perimeter. The absorbent layer can have an aperture or through-hole toward one end. The aperture can be about <NUM> in diameter. Over the transmission layer and absorbent layer lies a backing layer. The backing layer can be a high moisture vapor transmission rate (MVTR) film, pattern coated with acrylic adhesive. The high MVTR film and wound contact layer encapsulate the transmission layer and absorbent layer, creating a perimeter border of approximately <NUM>. The backing layer can have a <NUM> aperture that overlies the aperture in the absorbent layer. Above the hole can be bonded a fluidic connector that comprises a liquid-impermeable, gas-permeable semi-permeable membrane (SPM) or filter that overlies the aforementioned apertures.

In some embodiments, the wound dressings comprise a specific shape to confirm to an area of the body. The shape of the wound dressing can be tailored to a particular type of wound or a specific surgical incision to be treated. For example, wound dressings can be provided in specific shapes and sizes for application on post-breast surgeries. <FIG> illustrate embodiments of wound dressings with shapes that can be used for treatment after breast surgery. <FIG> illustrates an embodiment of a wound dressing <NUM> having a T shape. The T-shaped dressing can include an elongate portion <NUM>, which may be rectangular in shape, and a bridging portion <NUM>, which may also be rectangular in shape. The bridging portion <NUM> extends upwardly from the middle of the elongate portion <NUM> to form the T shape. The bridging portion <NUM> can have a first end <NUM> where the elongate portion <NUM> and the bridging portion <NUM> meet. The elongate portion <NUM> and bridging portion <NUM> can form a substantially right angle at the section where the elongate portion <NUM> and bridging portion <NUM> meet at the first end <NUM>. The bridging portion <NUM> can have a second end <NUM> at the end of the bridging portion <NUM> that is opposite the first end <NUM>.

In some embodiments, the wound dressing <NUM> has a length that runs along a longitudinal axis of the elongate portion and a width that runs perpendicular to the length. In some embodiments, the length of the elongate portion <NUM> is greater than the width of the elongate portion <NUM>. In some embodiments, the length of the bridging portion <NUM> is less than or equal to the width of the bridging portion <NUM>.

The wound dressing <NUM> can be a layered dressing similar to the wound dressings described with reference to <FIG>. The wound dressing <NUM> can include wound contact layer (not shown), transmission layer (not shown), an absorbent layer <NUM>, filter (not shown), and a backing layer <NUM> as described herein. The wound contact layer can be in contact with the wound surface. The transmission layer and absorbent layer <NUM> can be above the wound contact layer as described herein.

As shown in <FIG>, each layer of the T shaped dressing can comprise a T shape. For example, the absorbent layer <NUM> and underlying transmission layer can be T shaped as illustrated in <FIG>. The backing layer <NUM> and wound contact layer can have the same shape as the absorbent layer and transmission layer but can be larger to provide a perimeter <NUM> that extends beyond the edge of the absorbent and transmission layer. The backing layer <NUM> and the wound contact layer can be sealed at the perimeter <NUM> enclosing the transmission layer and absorbent layer <NUM> between. For example, the backing layer <NUM> and wound contact layer can have a T shape with a sealed perimeter <NUM> that can enclose the T-shaped transmission layer and absorbent layer <NUM> between.

A fluidic connector or port <NUM> can be placed over an opening in the backing layer <NUM> to communicate negative pressure to the wound dressing. The fluidic connector or port <NUM> is similar to the fluidic connector <NUM> as described with reference to <FIG> and <FIG> herein. The port <NUM> can be positioned on the bridging portion <NUM> of the T-shaped wound dressing. As shown in <FIG>, the port <NUM> can be positioned at the second end <NUM> of the bridging portion <NUM>. The T-shaped dressing can be sized and configured to be used as a dressing for a single breast. In other embodiments, the dressing can be made larger and be sized and configured to be positioned over both breasts with the bridge portion positioned between the breasts. <FIG> illustrates an embodiment of a negative pressure wound treatment system employing a wound dressing with a two lobe T shape. The dressing illustrated in <FIG> can have a substantially T shape similar to <FIG> with an elongated portion <NUM> and a bridging portion <NUM> extending upwardly from the middle of the elongate portion forming the T shape. The bridging portion can have a substantially rectangular shape. The lobed T-shaped dressing can have an elongate portion <NUM> that has two lobes 351a, 351b. The two lobes can have a curved shape as illustrated in <FIG> to shape around the breast or other area of the body. The bridging portion <NUM> can be connected to the two lobes 351a, 351b at a first end <NUM> of the bridging portion.

The lobed T-shaped wound dressing <NUM> of <FIG> can include a wound contact layer (not shown), a transmission layer (not shown), an absorbent layer <NUM>, filter (not shown), and a backing layer <NUM> as described herein. The wound contact layer can be in contact with the wound surface. The transmission layer and absorbent layer <NUM> can be above the wound contact layer as described herein. As shown in <FIG>, each layer of the lobed T-shaped dressing can comprise the same shape. For example, the absorbent layer <NUM> and underlying transmission layer can have the two lobed shape with the bridging portion <NUM> and the first end <NUM> as illustrated in <FIG>. The backing layer <NUM> and wound contact layer can have the same shape as the absorbent layer and transmission layer but can be larger to provide a perimeter <NUM> that extends beyond the edge of the absorbent and transmission layer. The backing layer <NUM> and the wound contact layer can be sealed at the perimeter <NUM> enclosing the transmission layer and absorbent layer <NUM> between. The absorbent layer <NUM> (and/or the underlying transmission layer) can be a continuous layer between the bridging portion and the elongate portion. For example, the absorbent layer and/or the transmission layer can be one piece of material that is continuous from the port and extend along the bridge potion and can have a narrow portion that extends between the two lobes at the first end <NUM> as shown in <FIG>.

The two lobed wound dressing can have a length that runs along a longitudinal axis of the elongate portion and a width that runs perpendicular to the length. In some embodiments, each lobe 351a and 351b of the elongate portion can have a length that is greater than the width of the lobe. The bridging portion <NUM> can have a length that is less than or equal to the width. The lobes 351a and 351b can have a lower edge 355a, 355b that is furthest from the port <NUM>. The lower edges 355a, 355b can have a curved shape. In some embodiments the lower edges 355a, 355b can be curved away from the port as shown in <FIG>. The lobes 351a and 351b can have as upper edge 356a, 356b that is opposite from the lower edge 355a, 355b. The upper edges 356a, 356b can have the same or substantially the same curvature as the lower edges 355a, 355b.

The bridging portion <NUM> can include a fluidic connector or port <NUM> at an opening in the backing layer <NUM>. The fluidic connector or port <NUM> can be positioned at a second end <NUM> that is on the opposite end of the bridging portion <NUM> from the first end <NUM>. The first end <NUM> communicates negative pressure from the port or fluidic connector <NUM> through the bridging portion to the two lobes 351a, 351b. The two lobes 351a, 351b of the lobed T-shaped dressing can be used as a single dressing that would cover both breasts. For example, lobe 351a can be used to cover the left breast of the patient while lobe 351b can be used to cover the right breast of the patient. In some embodiments, the single dressing that covers both breasts can have a bra shaped configuration similar to the shaped illustrated in <FIG>.

<FIG> illustrates an embodiment of the dressing covering surgical incision sites, illustrated in dashed lines. In some embodiments, the dressing of <FIG> includes a T-shape that is arranged to fit the T-shaped incision site for breast surgery. <FIG> illustrates an example of a surgical breast procedure and the corresponding incision lines shown post breast surgery. As can be seen in <FIG>, the incision can include a T-shaped incision that runs along the lower part of the breast. In some embodiments, this can be similar to an inframammary incision at the lower part of the breast where it meets the chest wall. An additional incision can be perpendicular to the lower section of the breast and extend toward the areola. In some procedures, an incision can be made around the nipple or areola. In some embodiments, this incision can be a periareolar incision. <FIG> illustrates surgical incision sites as shown by the dashed lines with relation to the T-shaped dressing of <FIG>. The T-shaped dressing can be used to fit over the surgical incision on a single breast. The elongated portion <NUM> of the dressing can be positioned to cover the incision at the lower section of the breast. The bridging portion <NUM> of the dressing can be positioned on the incision that extends from the lower section of the breast to the nipple or areola. As shown in <FIG>, in some embodiments, the port <NUM> at the second end <NUM> of the bridging portion <NUM> can be positioned on the area of the dressing that is over the incision around the areola.

<FIG> illustrates an embodiment of a two lobe wound dressing. The dressing illustrated in <FIG> can be bra-shaped similar to <FIG> with two lobes, one for each breast and a bridging portion <NUM> extending upwardly at an intersection between the two lobes. The bridging portion can have a substantially rectangular shape. The lobed bra-shaped dressing can have two lobes 381a, 381b. The two lobes can have a curved shape as illustrated in <FIG> to shape around the breast or other area of the body. The bridging portion <NUM> can be connected to the two lobes 381a, 381b at a first end <NUM> of the bridging portion located at the intersection between the two lobes. The two lobed wound dressing of <FIG> is similar to the two lobed wound dressing of <FIG>, however, the two lobed wound dressing of <FIG> has two circular or oval shaped lobes. The lobes 381a, 381b can be circular or oval in shape and can be fluidically connected to each other by a bridging portion <NUM>.

The two lobe wound dressing <NUM> of <FIG> can include a wound contact layer (not shown), a transmission layer (not shown), an absorbent layer <NUM>, filter (not shown), and a backing layer <NUM> as described herein. The wound contact layer can be in contact with the wound surface. The transmission layer and absorbent layer <NUM> can be above the wound contact layer as described herein. As shown in <FIG>, each layer of the lobed dressing can comprise the same shape. For example, the absorbent layer <NUM> and underlying transmission layer can have the two lobed shape with the bridging portion <NUM> and the first end <NUM> as illustrated in <FIG>. The backing layer <NUM> and wound contact layer can have the same shape as the absorbent layer and transmission layer but can be larger to provide a perimeter <NUM> that extends beyond the edge of the absorbent and transmission layer. The backing layer <NUM> and the wound contact layer can be sealed at the perimeter <NUM> enclosing the transmission layer and absorbent layer <NUM> between. The absorbent layer <NUM> (and/or the underlying transmission layer) can be a continuous layer between the bridging portion and the elongate portion. For example, the absorbent layer and/or the transmission layer can be one piece of material that is continuous from the port and extend along the bridge potion and can have a Y-shaped narrow portion that extends between the two lobes at the first end <NUM> as shown in <FIG>.

The bridging portion <NUM> can include a fluidic connector or port <NUM> at an opening in the backing layer <NUM>. The fluidic connector or port <NUM> can be positioned at a second end <NUM> that is on the opposite end of the bridging portion <NUM> from the first end <NUM>. The first end <NUM> communicates negative pressure from the port or fluidic connector <NUM> through the bridging portion to the two lobes 381a, 381b. The two lobes 381a, 381b of the lobed dressing can be used as a single dressing that would cover both breasts. For example, lobe 381a can be used to cover the left breast of the patient while lobe 381b can be used to cover the right breast of the patient and the bridging portion <NUM> positioned between the two lobes. In some embodiments, the single dressing that covers both breasts can have the circular shape configuration similar to the shaped illustrated in <FIG>.

<FIG> illustrates an embodiment of a triangular shaped dressing that can be one dressing that is used for both breasts. <FIG> illustrates an embodiment of a negative pressure wound treatment system employing a wound dressing with a two triangular shaped lobed dressing. The dressing illustrated in <FIG> can have two lobes 371a, 371b with a substantially triangular shape. The dressing can have an elongate portion <NUM> and a bridging portion <NUM> in the middle of the elongate portion between the two lobes. The two triangular shaped lobe dressing can have an elongate portion <NUM> that has two lobes 371a, 371b. The two lobes can each have a substantially triangular shape as illustrated in <FIG> to shape around the surgical incisions of the breast as shown in <FIG> or other area of the body. The bridging portion <NUM> can be connected to the two lobes 371a, 371b with the first lobe 371a on a first side of the bridging portion <NUM> and a second lobe 371b on a second side of the bridging portion <NUM> as shown in <FIG> illustrates an embodiment of the wound dressing with the fluid connector <NUM> extending downward from the elongate portion <NUM> and away from the middle of the breasts. In some embodiments, the dressing can be positioned over both breasts with the fluidic connector positioned between the breasts as illustrated in <FIG> and <FIG>.

The triangular shaped lobed wound dressing <NUM> of <FIG> can include a wound contact layer (not shown), a transmission layer (not shown), an absorbent layer <NUM>, filter (not shown), and a backing layer <NUM> as described herein. The wound contact layer can be in contact with the wound surface. The transmission layer and absorbent layer <NUM> can be above the wound contact layer as described herein. As shown in <FIG>, each layer of the triangular shaped lobe dressing can comprise the same shape. For example, the absorbent layer <NUM> and underlying transmission layer can have the two lobed shape with the bridging portion <NUM> as illustrated in <FIG>. The backing layer <NUM> and wound contact layer can have the same shape as the absorbent layer and transmission layer but can be larger to provide a perimeter <NUM> that extends beyond the edge of the absorbent and transmission layer. The backing layer <NUM> and the wound contact layer can be sealed at the perimeter <NUM> enclosing the transmission layer and absorbent layer <NUM> between. The absorbent layer <NUM> (and/or the underlying transmission layer) can be a continuous layer between the bridging portion and the elongate portion.

The two triangular shaped lobed wound dressing can have a length that runs along a longitudinal axis of the elongate portion and a width that runs perpendicular to the length. The lobes 371a and 371b can have edges <NUM> and corners <NUM>. In some embodiments, each lobe 371a and 371b of the elongate portion can have a long edge <NUM> that extends along the longitudinal axis on the lower portion of the dressing. The long edge <NUM> forms an edge of the first lobe 371a and the second lobe 371b and a lower portion of the bridging portion <NUM>.

The bridging portion <NUM> can include a fluidic connector or port <NUM> at an opening in the backing layer <NUM>. The fluidic connector or port <NUM> can be positioned at the bridging portion <NUM> between the two lobes 371a, 371b. The bridging portion <NUM> communicates negative pressure from the port or fluidic connector <NUM> through the bridging portion to the two lobes 371a, 371b.

As shown in <FIG>, the dressing can be positioned over both breasts with the port or fluidic connector <NUM> positioned on the bridging portion between the breasts. The two triangular shaped portions 371a, 371b can each cover a single breast. The two lobes 371a, 371b of the triangular shaped lobed dressing can be used as a single dressing that would cover both breasts. For example, lobe 371a can be used to cover the left breast of the patient while lobe 371b can be used to cover the right breast of the patient with the bridging portion <NUM> between the two lobes.

<FIG> illustrates an embodiment of a triangular shaped wound dressing. The wound dressing <NUM> can be a layered dressing similar to the wound dressings described with reference to <FIG>. The triangular shaped dressing can have edges <NUM> and corners <NUM>. The wound dressing <NUM> can include wound contact layer (not shown), transmission layer (not shown), an absorbent layer <NUM>, filter (not shown), and a backing layer <NUM> as described herein. The wound contact layer can be in contact with the wound surface. The transmission layer and absorbent layer <NUM> can be above the wound contact layer as described herein.

As shown in <FIG>, each layer of the triangular shaped dressing can comprise a triangular shape. For example, the absorbent layer <NUM> and underlying transmission layer can be triangular shaped as illustrated in <FIG>. The backing layer <NUM> and wound contact layer can have the same shape as the absorbent layer and transmission layer but can be larger to provide a perimeter <NUM> that extends beyond the edge of the absorbent and transmission layer. The backing layer <NUM> and the wound contact layer can be sealed at the perimeter <NUM> enclosing the transmission layer and absorbent layer <NUM> between. For example, the backing layer <NUM> and wound contact layer can have a triangular shape with a sealed perimeter <NUM> that can enclose the triangular shaped transmission layer and absorbent layer <NUM> between.

A fluidic connector or port <NUM> can be placed over an opening in the backing layer <NUM> to communicate negative pressure to the wound dressing. The fluidic connector or port <NUM> is similar to the fluidic connector <NUM> as described with reference to <FIG> and <FIG> herein. As shown in <FIG>, the port <NUM> can be positioned near an edge <NUM> of the triangular shaped dressing. The triangular shaped dressing can be used as one dressing for each breast. The triangular shaped dressing can be positioned over the T shaped incision similar to the incision shown in <FIG>. In some embodiments, at least one edge <NUM> of the triangular shaped dressing can be aligned parallel to the incision on the lower portion of the breast. In some embodiments, a corner <NUM> of the triangular shaped wound dressing can be positioned near the incision around the areola.

Embodiments of the wound dressings, wound dressing components, wound treatment apparatuses and methods described herein may also be used in combination or in addition to those described in International Application No. <CIT>, published as <CIT>, titled " WOUND DRESSING AND METHOD OF TREATMENT,". Additional embodiments of the wound dressings, wound dressing components, wound treatment apparatuses and methods described herein may also be used in combination or in addition to those described in <CIT>.

<FIG> illustrate the use of an embodiment of a negative pressure therapy wound treatment system being used to treat a wound site on a patient. Although these figures do not illustrate a wound treatment system such as described in <FIG> and <FIG>, it will be appreciated that similar steps may be utilized to treat post-surgical breast wounds. <FIG> shows a wound site <NUM> being cleaned and prepared for treatment. Here, the healthy skin surrounding the wound site <NUM> is preferably cleaned and excess hair removed or shaved. The wound site <NUM> may also be irrigated with sterile saline solution if necessary. Optionally, a skin protectant may be applied to the skin surrounding the wound site <NUM>. If necessary, a wound packing material, such as foam or gauze, may be placed in the wound site <NUM>. This may be preferable if the wound site <NUM> is a deeper wound.

After the skin surrounding the wound site <NUM> is dry, and with reference now to <FIG>, the wound dressing <NUM> may be positioned and placed over the wound site <NUM>. Preferably, the wound dressing <NUM> is placed with the wound contact layer over and/or in contact with the wound site <NUM>. In some embodiments, an adhesive layer is provided on the lower surface of the wound contact layer, which may in some cases be protected by an optional release layer to be removed prior to placement of the wound dressing <NUM> over the wound site <NUM>. Preferably, the dressing <NUM> is positioned such that the fluidic connector <NUM> is in a raised position with respect to the remainder of the dressing <NUM> so as to avoid fluid pooling around the port. In some embodiments, the dressing <NUM> is positioned so that the fluidic connector <NUM> is not directly overlying the wound, and is level with or at a higher point than the wound. To help ensure adequate sealing for TNP, the edges of the dressing <NUM> are preferably smoothed over to avoid creases or folds.

With reference now to <FIG>, the dressing <NUM> is connected to the pump <NUM>. The pump <NUM> is configured to apply negative pressure to the wound site via the dressing <NUM>, and typically through a conduit. In some embodiments, and as described herein, a fluidic connector <NUM> may be used to join the conduit <NUM> from the pump to the dressing <NUM>. Where the fluidic connector is adhered to the top layer of the wound dressing, a length of tubing may be coupled at a first end of the fluidic connector such that the tubing, or conduit, extends away from the fluidic connector parallel to the top of the dressing. In some embodiments the conduit may comprise a fluidic connector. It is expressly contemplated that a conduit may be a soft bridge, a hard tube, or any other apparatus which may serve to transport fluid. Upon the application of negative pressure with the pump <NUM>, the dressing <NUM> may in some embodiments partially collapse and present a wrinkled appearance as a result of the evacuation of some or all of the air underneath the dressing <NUM>. In some embodiments, the pump <NUM> may be configured to detect if any leaks are present in the dressing <NUM>, such as at the interface between the dressing <NUM> and the skin surrounding the wound site <NUM>. Should a leak be found, such leak is preferably remedied prior to continuing treatment.

Turning to <FIG>, additional fixation strips <NUM> may also be attached around the edges of the dressing <NUM>. Such fixation strips <NUM> may be advantageous in some situations so as to provide additional sealing against the skin of the patient surrounding the wound site <NUM>. For example, the fixation strips <NUM> may provide additional sealing for when a patient is more mobile. In some cases, the fixation strips <NUM> may be used prior to activation of the pump <NUM>, particularly if the dressing <NUM> is placed over a difficult to reach or contoured area.

Treatment of the wound site <NUM> preferably continues until the wound has reached a desired level of healing. In some embodiments, it may be desirable to replace the dressing <NUM> after a certain time period has elapsed, or if the dressing is full of wound fluids. During such changes, the pump <NUM> may be kept, with just the dressing <NUM> being changed.

In some embodiments, one or more wound dressings can be used to treat multiple wound or surgical sites. For example, two of the single breast dressings shown in <FIG> and <FIG> can be used to treat post-breast surgery sites. As described above one dressing can be placed over the left breast and one dressing can be placed over the right breast. Each of the single breast dressings can include a fluidic connector or port <NUM> connected to and extending from the dressing as shown in <FIG> and <FIG>. The fluidic connector or port <NUM> is similar to the fluidic connector <NUM> as described with reference to <FIG> and <FIG> herein. As described above with reference to <FIG> and <FIG>, the fluidic connector or port <NUM> can be positioned on the dressing. The dressing can be T-shaped or triangular as illustrated in <FIG> and <FIG>, respectively, or can be any other shape utilized for wound dressings including, but not limited to, rectangular, square, or circular dressing shapes. The T-shaped or triangular shaped dressing can be positioned over the T-shaped incision similar to the incision shown in <FIG> as described herein.

When multiple dressings are used to cover the multi-surgery sites, the two or more dressings used in combination can be referred to collectively as a multisite dressing. The multisite dressing can be utilized after a breast surgery as described previously.

<FIG> and <FIG> illustrate the fluid connector or port <NUM> extending from the dressing. The multisite dressing can include two dressings used to cover the multiple surgical sites. Each dressing can include a fluid connector or port <NUM> extending from the dressings for connection to a conduit and/or pump to apply negative pressure to the wound site as described herein. The fluid connector can include a coupling <NUM> disposed at the proximal end of the fluidic connector. As described with reference to <FIG>, the pump can be connected via a tube to the coupling or can be directly connected to the coupling.

In some embodiments, to minimize the bulk and weight carried by the patient the two fluidic connectors can be connected to a single pump by utilizing a multisite connector. For example, in some embodiments, two dressings can include two fluidic connectors and couplings, one extending from each of the dressings, and the two fluidic connectors can be connected to the single pump with a Y-shaped connector. The Y-shaped connector can be provided in a kit with multisite dressings. In some embodiments, for use in post-breast surgery applications, the Y-shaped connector can be provided in a kit with two dressings, one dressing for each breast, and a pump. In some embodiments, the pump, multisite dressing, and multisite connector can be used for other surgeries including but not limited to donor site surgeries.

<FIG> and <FIG> illustrate an embodiment of a Y-shaped connector that can be used with a multisite dressing. The Y-shaped connector can include three conduit attachment portions <NUM>, <NUM>, <NUM>. A pump conduit attachment portion <NUM> can be used to connect to a conduit or tubing extending from a pump or to connect to the pump itself. The pump conduit attachment portion <NUM> can include a male non-luer connector at a proximal end of the Y-shaped connector. The male connector can attach to a female connector of a conduit or pump. The pump conduit attachment portion <NUM> has a shaft <NUM> extending from the attachment portion and forming the bottom portion of the Y shape of the connector.

The Y-shaped connector also includes two dressing conduit attachment portions <NUM>, <NUM>. The dressing conduit attachment portions <NUM>, <NUM> can be used to connect to the coupling of the fluidic connector extending from a dressing. In some embodiments, a conduit or tubing can be used to connect the fluidic connector to the Y-shaped connector. The conduit or tubing may be a soft bridge, a hard tube, or any other apparatus which may serve to transport fluid. The conduit or tubing can include a coupling at a proximal end and at a distal end. The conduit or tubing can be connected to the coupling of the fluidic connector at the distal end and connected to the conduit attachment portions of the Y-shaped connector at the proximal end of the conduit.

The dressing conduit attachment portion <NUM>, <NUM> can include a female non-luer connector at a distal end of the Y-shaped connector. The female connector can attach to a male connector of the coupling of the fluidic connector or to the coupling of the conduit. In some embodiments, the fluidic connector or the conduit can include a clamp, cap, or other closure mechanism to allow the user to monitor or change one dressing while the other dressing continues to apply negative pressure. In some embodiments the closure mechanism can be a valve, for example, a non-return valve. The dressing conduit attachment portions <NUM>, <NUM> include shafts <NUM>, <NUM>, respectively, forming the top portions of the Y shape of the connector as shown in <FIG>. The proximal ends of shafts <NUM>, <NUM> and the distal end of shaft <NUM> meet at a joint <NUM>. In some embodiments, the joint <NUM> can include a hinge that allows rotation of the shafts <NUM>, <NUM>, <NUM> about the joint <NUM>. In some embodiments, only shafts <NUM>, <NUM> of the dressing conduit attachment portions can more relative to the joint <NUM> and the shaft <NUM> of the pump conduit attachment portion is fixed. In some embodiments, the whole Y-shaped connector will be in two parts that allow <NUM>° rotation. <FIG> illustrates an embodiment of the Y-shaped connector that is formed of two freely-rotating parts that allow rotation of each part relative to the other. The rotation of the Y-shaped connector can allow the user to twist the pump around while the dressings and conduits extending from the dressing remain stationary.

In some embodiments, the male and female non-luer connectors can be a rigid plastic. In some embodiments, the shafts <NUM>, <NUM>, <NUM> can be a flexible plastic tubing. In some embodiments, the Y-shaped connector can be encased in a soft silicone sleeve to increase patient comfort and prevent the Y-shaped connector from becoming a pressure point.

Utilizing the Y-shaped connector illustrated in <FIG> to attach a single pump to the two dressings, the pump can draw pressure in the two dressings simultaneously. The performance and fluid management of the multisite dressing and Y-connector is equivalent to a control test of the standard single dressing with single pump setup.

Claim 1:
A negative pressure wound therapy apparatus, comprising:
a wound dressing comprising an elongate portion having a longitudinal axis and a bridging portion, wherein the bridging portion comprises a first end and a second end, wherein the bridging portion extends away from a middle portion of the elongate portion at a substantially right angle from the longitudinal axis at the first end of the bridging portion, the wound dressing comprising within both the elongate portion and the bridging portion:
a wound contact layer configured to be positioned in contact with a wound;
an absorbent layer and/or transmission layer over the wound contact layer; and
a cover layer configured to cover and form a seal over the wound contact layer and the absorbent layer and/or transmission layer, wherein the cover layer comprises an aperture at a second end of the bridging portion; and a fluidic connector positioned over the aperture in the cover layer at the second end of the bridging portion; and
characterized in that the elongate portion is sized and configured to cover one or more post-surgical breast wounds, with the bridging portion being located between the breasts, the elongate portion comprising a first lobe on a first side of the bridging portion and a second lobe on a second side of the bridging portion and wherein the absorbent layer/and or transmission layer is a continuous layer between the bridging portion and the elongate portion and has a narrow portion that extends between the first and second lobes at the first end.