Patent Description:
The present invention relates generally to the field of wound dressings, and more particularly to wound dressings for breast cavities.

Breast implants can become infected due to a variety of reasons. In particular, after malignant tumor removal in a breast, an implant made be surgically placed within the breast cavity. If such an implant becomes infected, these infections may be localized in the tissue surrounding the implant or may be systemic (e.g., affecting the entire body rather than the localized tissue surrounding the implant). The infection rate may be higher for patients who had breast cancer and have had a mastectomy to reconstruct the breast. However, infection can occur even if the implants are placed for cosmetic reasons. It would be desirable to provide a dressing for treating infections in a body cavity such as a post-surgical breast cavity.

<CIT> and <CIT> disclose wound dressings.

One implementation of the present invention is a dressing for an internal cavity as claimed in claim <NUM>. The dressing includes a connector, a negative pressure pathway layer, an instillation pathway layer, a negative pressure manifold, and an instillation manifold. The negative pressure pathway layer has a proximate end coupled to the connector and a distal end that is substantially free. The instillation pathway layer has a proximate end coupled with the connector and a distal end that is substantially free. The negative pressure manifold is disposed within the negative pressure pathway layer. A proximate end of the negative pressure manifold is fluidly coupled with a first channel of the connector. The instillation manifold is disposed within the instillation pathway layer. The proximate end of the instillation manifold is fluidly coupled with a second channel of the connector. The negative pressure pathway layer and the instillation pathway layer are configured to cooperatively form an inner volume therebetween. The inner volume is configured to receive a space filler. The negative pressure pathway layer, the instillation pathway layer, and the space filler are collectively configured to be positioned within the internal cavity.

Various objects, aspects, features, and advantages of the disclosure will become more apparent and better understood by referring to the detailed description taken in conjunction with the accompanying drawings, in which like reference characters identify corresponding elements throughout.

Referring generally to the FIGURES, various negative pressure dressings and systems for breast cavities are shown. The dressing can include a negative pressure pathway layer and an instillation pathway layer. The negative pressure pathway layer and the instillation pathway layer each include a manifold that is configured to absorb, transport, wick, etc., fluid therethrough. The negative pressure pathway layer includes a negative pressure manifold, an outer film layer and an inner film layer. The instillation pathway layer includes an instillation manifold, an outer film layer and an inner film layer. The outer film layers and/or the inner film layers of the negative pressure pathway layer and the instillation pathway layer can include holes, openings, perforations, fenestrations, apertures, etc., to allow or facilitate the transfer of fluid therethrough.

The negative pressure pathway layer and the instillation pathway layer can be fixedly and/or fluidly coupled at a first end with a connector. The negative pressure pathway layer and the instillation pathway layer may also be sealingly coupled with each other at a second or distal end with each other. In a first embodiment, the negative pressure pathway layer and the instillation pathway layer are not sealingly coupled with each other at the distal or second end, but rather, are free at the second or distal end. In a second embodiment, the negative pressure pathway layer and the instillation pathway layer are sealingly coupled (e.g., welded using a radio frequency/high frequency ("RF/HF") weld) so that the negative pressure pathway layer and the instillation pathway layer cooperatively define a sealed inner volume.

The connector can include various channels that are configured to facilitate the transport of fluid to or from the manifolds of the negative pressure pathway layer and the instillation pathway layer. For example, a first channel may fluidly couple with the negative pressure manifold so that fluid absorbed, wicked, transferred, etc., through the negative pressure manifold can be transferred through the first channel of the connector. Likewise, a second channel may extend through the connector and fluidly couple with the instillation manifold. Instillation fluid can be provided through the second channel to the instillation manifold. The instillation manifold may absorb, wick, transfer, transport, etc., the instillation fluid. The instillation fluid may exit from the instillation manifold through the openings, apertures, perforations, fenestrations, etc., in the inner and/or outer layer of the instillation pathway layer.

The dressing can be positioned within a patient's breast cavity. If the second or distal ends of the instillation pathway layer and the negative pressure pathway layer are free, the instillation pathway layer and the negative pressure pathway layer may be wrapped around a space filler (e.g., a breast expander, a temporary implant, etc.). If the second or distal ends of the instillation pathway layer and the negative pressure pathway layer are sealed or welded with each other, the dressing may have the form of an inflatable bladder. The dressing can be implanted into the patient's breast cavity by a medical professional. After the dressing is implanted into the patient's breast cavity, the dressing may be inflated (e.g., if the second or distal ends of the instillation pathway layer and the negative pressure pathway layer are sealed or welded with each other). The sealed inner volume of the dressing may be fluidly coupled with a third or central or medial channel of the connector. A fluid delivery device can be removably fluidly coupled with the third channel of the connector and may be operated to introduce fluid (e.g., liquid such as a saline solution, gas, air, etc.) to the sealed inner volume of the dressing. The fluid delivery device can be a syringe or a pump, or any other device capable of delivering fluid to the sealed inner volume of the dressing. The dressing can be inflated until the dressing reaches a desired size.

The connector may be fluidly coupled with a vacuum tube and an instillation tube. The vacuum tube can be configured to fluidly couple (e.g., removably) with the first channel of the connector. The instillation tube can be configured to fluidly couple (e.g., removably) with the second channel of the connector. The instillation tube and the vacuum tube can be fluidly coupled with a therapy unit that is configured to both draw a negative pressure at the patient's breast cavity through the vacuum tube as well as to deliver instillation fluid to the breast cavity through the instillation tube. The therapy unit may include a pneumatic pump that is configured to draw a negative pressure and wound fluid from/at the patient's breast cavity through the vacuum tube and the negative pressure pathway layer. The therapy unit can also include an instillation pump that is configured to deliver or drive the instillation fluid to the patient's breast cavity through the instillation tube and the instillation pathway layer.

In other embodiments, the vacuum tube, the instillation tube, and the therapy unit are configured for use with a permanent breast implant. For example, the instillation tube can be surgically inserted so that an open end of the instillation tube fluidly couples with an upper portion of the patient's breast cavity. In this way, instillation fluid can be delivered to the patient's breast cavity at the upper portion. The breast cavity can include a permanent breast implant that is positioned therewithin. The instillation fluid can be provided to the patient's breast cavity at the upper portion, and may flow through a space defined between the permanent breast implant and an interior facing surface of the patient's breast cavity. The vacuum tube can be surgically inserted and fluidly coupled at a bottom or lower portion of the patient's breast cavity. The vacuum tube can be configured to draw a negative pressure within the patient's breast cavity. The vacuum tube can also be configured to draw or remove fluid from the patient's breast cavity (e.g., exuded wound fluid, instillation fluid, etc.). In this way, instillation fluid can be provided to the patient's breast cavity at the upper portion, may flow downwards to the lower portion, and be removed from the patient's breast cavity through the vacuum tube.

Breast implants may become infected, for example, after malignant tumor removal in the breast. In some cases, permanent implants can become infected after they have been surgically inserted. This may occur weeks or even months after the implant is placed. Other approaches to treating implant infection include removing the breast implant, treating the infection with the implant via systemic antibiotics, or the use of drains to administer localized washes and antibiotics to the implant site. However, in most cases, the implant must be removed, the capsule thoroughly washed, etc., so that the infection can be controlled. Such procedures may take <NUM>-<NUM> months and can be uncomfortable for patients. Additionally, removing the infected implant can be distressing to the patient, since the patient's breasts may become unsymmetrical. Advantageously, the systems and methods described herein facilitate maintaining an implant in the breast cavity, while administering negative pressure therapy to control the infection. Advantageously, this facilitates a less invasive approach to treating infections in bodily cavities (e.g., breast cavities) while providing symmetrical appearances and thereby reducing patient distress.

Referring to <FIG>, a dressing assembly <NUM> for a breast cavity or other internal bodily cavity is shown. Dressing assembly <NUM> includes a dressing <NUM> and a connection assembly <NUM>. Connection assembly <NUM> includes a connector <NUM>, and several conduits, tubular members, pipes, hoses, tubes, etc., shown as instillation tube <NUM> and vacuum tube <NUM>. Connector <NUM> includes a first portion, a vacuum portion, a negative pressure portion, etc., shown as vacuum portion <NUM>, and a second portion, an instillation portion, etc., shown as instillation portion <NUM>. Vacuum portion <NUM> includes a first channel, a first bore, a through-hole, a fluid passageway, a fluid path, an opening, an inner volume, an aperture, etc., shown as vacuum channel <NUM>. Instillation portion <NUM> includes a second channel, a second bore, a through-hole, a fluid passageway, a fluid path, an opening, an inner volume, an aperture, etc., shown as instillation channel <NUM>. Instillation channel <NUM> may extend through instillation portion <NUM> of connector <NUM>, while vacuum channel <NUM> extends through vacuum portion <NUM> of connector <NUM>.

Instillation tube <NUM> can include an inner volume <NUM>, and an inlet end <NUM>. An outlet end of instillation tube <NUM> is the opposite end of instillation tube <NUM> that may be fluidly coupled with instillation channel <NUM>. Likewise, vacuum tube <NUM> can include an inner volume <NUM> and an inlet end <NUM>. An outlet end of vacuum tube <NUM> is the opposite end of vacuum tube <NUM> that may be fluidly coupled with vacuum channel <NUM>.

Dressing <NUM> includes a manifold portion, a manifold member, etc., shown as negative pressure pathway layer <NUM>, and an instillation portion, an instillation member, etc., shown as instillation pathway layer <NUM>. Negative pressure pathway layer <NUM> and instillation pathway layer <NUM> can be elongated members that couple (e.g., fixedly, fluidly, etc.) at one end with connector <NUM>, and are free at an opposite end. Negative pressure pathway layer <NUM> may be coupled (e.g., fixedly) with connector <NUM> at proximate end <NUM>, while distal end <NUM> of negative pressure pathway layer <NUM> is free. Likewise, instillation pathway layer <NUM> can be coupled (e.g., fixedly) with connector <NUM> at proximate end <NUM>, while distal end <NUM> of instillation pathway layer <NUM> is free.

Negative pressure pathway layer <NUM> can include a manifold structure, a foam structure, a gauze structure, a webbed material, a thermally molded structure, etc., shown as negative pressure manifold <NUM> that is configured to facilitate the absorption of fluid therethrough. Negative pressure manifold <NUM> can extend outwards from connector <NUM> and may be fixedly and/or fluidly coupled with connector <NUM> at proximate end <NUM>. Distal end <NUM> of negative pressure manifold <NUM> can be free.

Instillation pathway layer <NUM> can include a similar manifold structure, a similar foam structure, a gauze structure, a webbed material, a thermally molded structure, etc., shown as instillation manifold <NUM>. Instillation manifold <NUM> can be made from a material that is the same as or similar to negative pressure manifold <NUM>. In some embodiments, instillation manifold <NUM> and negative pressure manifold <NUM> are manufactured from a hydrophilic material. The hydrophilicity of instillation manifold <NUM> may be greater than the hydrophilicity of negative pressure manifold <NUM>.

Instillation manifold <NUM> can be fluidly coupled with instillation channel <NUM>. In some embodiments, instillation manifold <NUM> is received within instillation channel <NUM>. Fluid can be provided to instillation manifold <NUM> through instillation channel <NUM>. The fluid may be wicked or absorbed through instillation manifold <NUM> and provided to a body cavity (e.g., a breast cavity) in which dressing assembly <NUM> or dressing <NUM> is positioned. The fluid may be driven to absorb, wick, flow, or more generally, be transferred through instillation manifold <NUM> due to a negative pressure in the body cavity.

Negative pressure manifold <NUM> can be fluidly coupled with vacuum channel <NUM>. In some embodiments, negative pressure manifold <NUM> is received within vacuum channel <NUM>. A negative pressure can be drawn within the cavity in which dressing assembly <NUM> or dressing <NUM> is positioned through negative pressure manifold <NUM>. Negative pressure manifold <NUM> can also be configured to wick, absorb, or more generally, transfer fluid (e.g., wound exudate) from the cavity (e.g., from the breast cavity). The fluid can be wicked, absorbed, transferred, or may flow through negative pressure manifold <NUM> to vacuum channel <NUM>. The fluid can then be drawn into a therapy unit that produces or draws down the negative pressure. In some embodiments, the therapy unit is fluidly coupled with the vacuum channel <NUM> and the instillation channel <NUM>. The therapy unit can be configured to draw a negative pressure at the cavity while also providing instillation fluid to the cavity.

Referring particularly to <FIG>, the free ends (e.g., distal end <NUM> and distal end <NUM>) can be adjusted or translated such that an inner volume, a space, an opening, etc., shown as inner volume <NUM> is formed or defined between negative pressure pathway layer <NUM> and instillation pathway layer <NUM>. A space filler, an implant, a permanent implant, a temporary implant, etc., shown as space filler <NUM> can be positioned within inner volume <NUM>, between negative pressure pathway layer <NUM> and instillation pathway layer <NUM>. Space filler <NUM> can be a breast expander, an implant, etc., or any other object (e.g., an expandable or inflatable bladder). Instillation pathway layer <NUM> and negative pressure pathway layer <NUM> can be wrapped around space filler <NUM> such that instillation pathway layer <NUM>, negative pressure pathway layer <NUM>, and space filler <NUM> are positioned within the cavity. An interior or inwards facing surface of negative pressure pathway layer <NUM> and instillation pathway layer <NUM> can be configured to directly contact or engage space filler <NUM>. Likewise, an exterior surface of negative pressure pathway layer <NUM> and instillation pathway layer <NUM> can be configured to engage or directly contact an interior or inwards facing surface of the cavity.

Referring particularly to <FIG>, negative pressure pathway layer <NUM> and/or instillation pathway layer <NUM> can have an overall length <NUM>. Negative pressure pathway layer <NUM> and instillation pathway layer <NUM> can be elongated members that extend substantially an entire length of dressing <NUM>. Negative pressure pathway layer <NUM> and instillation pathway layer <NUM> can each have a width <NUM>. In some embodiments, width <NUM> is between <NUM> and <NUM> millimeters. Negative pressure pathway layer <NUM> and/or instillation pathway layer <NUM> can have a thickness of <NUM> to <NUM> millimeters.

Dressing <NUM> can include multiple negative pressure pathway layers <NUM> and multiple instillation pathway layers <NUM>, or multiple negative pressure manifolds <NUM> and multiple instillation manifolds <NUM>. Manifolds <NUM> and <NUM> may function as legs, webs, fingers, etc., to provide or distribute the instillation fluid (e.g., to provide the instillation fluid to the cavity in multiple locations) and to produce a uniform/distributed negative pressure within the cavity. For example, negative pressure pathway layer <NUM> and instillation pathway layer <NUM> can include multiple manifolds <NUM> and <NUM> (e.g., open-celled foam strips) to evenly distribute the negative pressure and the instillation fluid. In some embodiments, the film layers <NUM> and <NUM> are formed or molded to include channels for the multiple manifolds <NUM> and <NUM> to extend through.

Referring particularly to <FIG>, negative pressure manifold <NUM> of negative pressure pathway layer <NUM> can be positioned between a first or an outer or a top film layer <NUM> and a second or an inner or a bottom film layer <NUM>. Film layers <NUM> and <NUM> can be polyurethane layers that are spaced a distance apart. For example, film layers <NUM> and <NUM> can be a Vancive MED-<NUM> film. Negative pressure manifold <NUM> is sandwiched between film layers <NUM> and <NUM> and can extend along film layers <NUM> and <NUM> through the space defined therebetween. Negative pressure manifold <NUM> can be or include a foam webbing, a three-dimensional textile, a web, a gauze, a vacuum formed structure, an embossed structure, etc. For example, negative pressure manifold <NUM> can be defined between outer film layer <NUM> and inner film layer <NUM>. Outer film layer <NUM> and inner film layer <NUM> can be thermoformed such that one or more channels, vacuum passageways, passages, etc., extend therebetween film layers <NUM> and <NUM> and fluidly couple with vacuum channel <NUM>. Instillation pathway layer <NUM> can be configured similarly to negative pressure pathway layer <NUM> and may include similar film layers with instillation manifold <NUM> positioned therebetween. Outer film layer <NUM> and inner film layer <NUM> can be polyurethane film layers. In some embodiments, outer film layer <NUM> and inner film layer <NUM> have a thickness of approximately <NUM> micrometers.

In some embodiments, outer film layer <NUM> includes one or more perforations, fenestrations, openings, etc. The one perforations can be configured to facilitate the egress or entry of fluid between the cavity and the spaced defined between film layers <NUM> and <NUM>. For example, fluid may flow through the space defined between film layers <NUM> and <NUM> of instillation pathway layer <NUM>, and exit the space through the openings of outer film layer <NUM>. Instillation manifold <NUM> can be positioned between film layers <NUM> and <NUM> and may facilitate the transport of instillation fluid through the space between film layers <NUM> and <NUM> from instillation channel <NUM> to various locations within the cavity. Likewise, negative pressure manifold <NUM> can be positioned between film layers <NUM> and <NUM> and may facilitate the transport of fluid from the cavity towards a negative pressure source (e.g., towards a therapy unit, towards connector <NUM>, etc.). Fluid within the cavity (e.g., exuded wound fluid, instillation fluid, etc.) can be transferred to negative pressure manifold <NUM> through the openings in outer film layer <NUM>. Additionally, the openings in outer film layer <NUM> can facilitate providing the negative pressure to the cavity.

In some embodiments, outer film layer <NUM> and inner film layer <NUM> include thermoformed passageways, structures, etc. For example, outer film layer <NUM> and inner film layer <NUM> may be integrally formed with each other but offset a distance apart to define various passageways or fluid flow paths therebetween. If this is the case, outer film layer <NUM> and inner film layer <NUM> may be thicker (e.g., <NUM> micrometers to <NUM> micrometers). Outer film layer <NUM> and inner film layer <NUM> can have a uniformed thickness, or may have a non-uniform thickness. For example, outer film layer <NUM> and inner film layer <NUM> can thicker at specific areas (e.g., where negative pressure manifold <NUM> and/or instillation manifold <NUM> are attached or coupled with outer film layer <NUM> and inner film layer <NUM>).

Referring particularly to <FIG> and <FIG>, dressing <NUM> can include one or more radio-opaque strips <NUM>. Radio opaque strips can be printed or otherwise positioned on dressing <NUM>. In some embodiments, radio-opaque strips <NUM> are positioned on one of the film layers <NUM> and/or <NUM>. Radio-opaque strips <NUM> can be viewable with an X-ray, thereby allowing a position of dressing <NUM> to be viewed to ensure that dressing <NUM> has not shifted in the cavity. Advantageously, radio-opaque strips <NUM> facilitate allowing placement, alignment, and re-positioning of dressing <NUM>. A technician or caregiver can use an X-ray to determine if dressing <NUM> should be repositioned or if dressing <NUM> has maintained a proper position within the cavity.

Referring particularly to <FIG>, connector <NUM> is shown in greater detail, according to some embodiments. Connector <NUM> can include a valve <NUM> that is selectable between a first position (shown in <FIG>) and a second position (shown in <FIG>). When valve <NUM> is in the first position, instillation fluid is provided through instillation channel <NUM> to instillation manifold <NUM>. When valve <NUM> is in the first position, a negative pressure can be drawn through vacuum channel <NUM>. Vacuum channel <NUM> may fluidly couple with negative pressure manifold <NUM> when in the first position. Exuded fluid from the cavity can be drawn through vacuum channel <NUM> as well.

When connector <NUM> is switched or transitioned into the second position (shown in <FIG>), the instillation fluid enters connector <NUM> through instillation channel <NUM> but exits connector <NUM> through vacuum channel <NUM>. Likewise, the exuded fluid drawn by the therapy unit or the negative pressure may enter connector <NUM> through instillation channel <NUM> from instillation manifold <NUM>, and be delivered to the therapy unit or the negative pressure source (e.g., thereby exiting connector <NUM>) through vacuum channel <NUM>. In this way, connector <NUM> can be cross-plumbed such that a direction of fluid removal/fluid delivery can be reversed upon transitioning valve <NUM> between the first position and the second position. In this way, when the patient, caregiver, user, etc., reverses direction of connector <NUM> by selectively adjusting valve <NUM>, a negative pressure/instillation fluid delivery direction is reversed, without requiring removal and reversal of instillation tube <NUM> and vacuum tube <NUM>. Advantageously, connector <NUM> can be cross-plumbed to facilitate selective bidirectionality of instillation fluid delivery/fluid removal.

Referring particularly to <FIG>, a bottom view of dressing assembly <NUM> is shown, according to some embodiments. As shown, dressing <NUM> includes three instillation pathway layers <NUM> that extend along a bottom side of dressing <NUM>. Dressing <NUM> may also include three negative pressure pathway layers <NUM> that extend along dressing <NUM> similarly to instillation pathway layers <NUM> but along a top side of dressing <NUM>. In some embodiments, instillation pathway layer <NUM> and negative pressure pathway layers <NUM> extend on opposite sides of dressing <NUM>. In other embodiments, instillation pathway layers <NUM> and negative pressure pathway layers <NUM> are alternated such that each instillation pathway layer <NUM> is positioned between a pair of negative pressure pathway layers <NUM> and such that each negative pressure pathway layer <NUM> is positioned between a pair of instillation pathway layers <NUM>.

Referring particularly to <FIG> and <FIG>, fluid flow paths of dressing assembly <NUM> are shown, according to some embodiments. Specifically, an instillation fluid flow path and an exuded fluid flow path are shown. The instillation fluid flow path extends through instillation tube <NUM>, connector <NUM>, and instillation manifold <NUM> of instillation pathway layer <NUM>. The instillation fluid flows through instillation tube <NUM>, connector <NUM>, and is provided to instillation manifold <NUM>. The instillation fluid may saturate instillation manifold <NUM> and may exit instillation manifold <NUM> into the cavity. In some embodiments, the instillation fluid is driven to exit instillation manifold <NUM> into the cavity due to the negative pressure in the cavity.

Exuded fluid (e.g., instillation fluid) is drawn into negative pressure manifold <NUM> from within the cavity. The exuded fluid is then transferred through negative pressure manifold <NUM> due to the negative pressure drawn therethrough. The exuded fluid may be absorbed, wicked, or otherwise transferred through negative pressure manifold <NUM>. The exuded fluid is then transferred through connector <NUM> to vacuum tube <NUM>. The exuded fluid is transferred through vacuum tube <NUM> to a canister, an exuded fluid container, etc. The exuded fluid can be drawn out of the cavity and transferred to the canister due to the negative pressure drawn by the therapy unit.

Referring particularly to <FIG>, dressing assembly <NUM> is shown positioned within a cavity <NUM> of a patient's breast <NUM>, according to some embodiments. The instillation fluid can be transferred to cavity <NUM> from a therapy unit <NUM> through instillation tube <NUM>. The instillation fluid is then provided to cavity <NUM> through instillation manifold <NUM>. The instillation fluid may transfer through openings, holes, apertures, perforations, fenestrations, etc., shown as openings <NUM>. Openings <NUM> extend through outer film layer <NUM> and/or inner film layer <NUM> of instillation pathway layer <NUM> and film layers <NUM> and <NUM> of negative pressure pathway layer <NUM> to fluidly couple instillation manifold <NUM> and negative pressure manifold <NUM> with cavity <NUM>. In some embodiments, openings <NUM> extend through only outer film layer <NUM>. Therapy unit <NUM> may be a PREVENA™ Incision Management System, a V. ULTA™ Therapy System, etc..

The instillation fluid is provided to cavity <NUM> through openings <NUM>. The instillation fluid can then wash, flush, treat, sterilize, etc., cavity <NUM>, tissues surrounding cavity <NUM>, space filler <NUM>, etc. The instillation fluid can be drawn through openings <NUM> of outer film layer <NUM> of negative pressure pathway layer <NUM> and removed from cavity <NUM> along the exuded fluid flow path through negative pressure manifold <NUM>. The instillation fluid can be drawn along the exuded fluid flow path with exuded wound fluid. The fluid (e.g., the instillation fluid and/or the exuded fluid) is then transferred or drawn to therapy unit <NUM> through vacuum tube <NUM>.

In this way, a wash direction of fluid can be produced within cavity <NUM>. For example, the wash direction may be a general direction that fluid is provided/removed from cavity <NUM>. The instillation fluid can be provided on a first side or along a first end of dressing <NUM>, and drawn through cavity <NUM> to a second or opposite side where the fluid is removed from cavity <NUM>. In this way, fluid within cavity <NUM> may be provided on the first side or at the first end, flow to the opposite side or the opposite end, and be removed from cavity <NUM> at the opposite side or the opposite end. The direction that the fluid generally flows in within cavity <NUM> is the "wash direction. " Operating connector <NUM> to cross-plumb the vacuum tube <NUM> and the instillation tube <NUM> can result in selectively reversing the wash direction within cavity <NUM> such that instillation fluid is provided at the second side or the second end of cavity <NUM> and removed from cavity <NUM> at the first side or at the first end.

The first side can be a side or end of dressing <NUM> that faces or is directed towards ribs <NUM> of the patient. For example, instillation pathway layer <NUM> may face inwards (e.g., towards the patient's ribs <NUM>), while negative pressure pathway layers <NUM> can face outwards (e.g., away from the patient's ribs <NUM>). In this way, instillation fluid can be provided to cavity <NUM> at the spine-facing side of dressing <NUM>, drawn to the front side of dressing <NUM>, and removed from cavity <NUM>.

Referring particularly to <FIG>, dressing assembly <NUM> is shown, according to another embodiment not according to the invention. Specifically, dressing assembly <NUM> is shown as an inflatable dressing. Dressing assembly <NUM> can be the same as or similar to dressing assembly <NUM> as described in greater detail above with reference to <FIG>. Specifically, dressing assembly <NUM> includes negative pressure pathway layer <NUM>, instillation pathway layer <NUM>, vacuum tube <NUM>, instillation tube <NUM>, and connector <NUM>.

Negative pressure pathway layer <NUM> and instillation pathway layer <NUM> can be joined, welded, sealed, etc. with each other at their distal ends <NUM> and <NUM>. Negative pressure pathway layer <NUM> and instillation pathway layer <NUM> can be sealed at a weld <NUM>. In this way, negative pressure pathway layer <NUM> and instillation pathway layer <NUM> cooperatively define a sealed inner volume <NUM> which can be filled with a fluid to thereby inflate dressing <NUM>.

Negative pressure pathway layer <NUM> and instillation pathway layer <NUM> can be joined along at least a portion of their perimeter. In some embodiments, negative pressure pathway layer <NUM> and instillation pathway layer <NUM> each include an edge or outer periphery that are joined, welded, adhered, integrally formed, vacuum sealed, etc., with each other. Negative pressure pathway layer <NUM> and instillation pathway layer <NUM> can be substantially thin planar (e.g., flexible) members that cooperatively form a three-dimensional inner volume therewithin. Weld <NUM> may form a fluidic seal around at least a portion of the perimeters of negative pressure pathway layer <NUM> and instillation pathway layer <NUM>. Negative pressure pathway layer <NUM> and instillation pathway layer <NUM> may be coupled (e.g., fluidly sealed) along different portions of their perimeters and may form a three-dimensional semi-elliptical shape.

Negative pressure pathway layer <NUM> and instillation pathway layer <NUM> can each include a film member, a layer, a polyurethane film, etc., shown as film <NUM>. Film <NUM> may extend centrally through negative pressure pathway layer <NUM> and instillation pathway layer <NUM> (e.g., through instillation manifold <NUM> and/or negative pressure manifold <NUM>) and may be sealed at their free ends at weld <NUM>. In other embodiments, films <NUM> are outer film layers <NUM>, while in other embodiments, films <NUM> are inner film layers <NUM>. In some embodiments, weld <NUM> is an RF/HF weld. Instillation manifold <NUM> and/or negative pressure manifold <NUM> can be manufactured from a felted or compressed foam. The felted foam may be configured to stretch or expand as dressing <NUM> is inflated.

Referring particularly to <FIG>, connector <NUM> is shown to include vacuum channel <NUM>, instillation channel <NUM>, and a fill channel <NUM>, according to some embodiments. Vacuum channel <NUM> is configured to fluidly couple vacuum tube <NUM> with negative pressure pathway layer <NUM>, while instillation channel <NUM> is configured to fluidly couple instillation tube <NUM> with instillation pathway layer <NUM>. Fill channel <NUM> can extend through connector <NUM> and may fluidly couple with inner volume <NUM> of dressing <NUM>. Inner volume <NUM> can be filled with a fluid, a gas, a liquid, etc., through fill channel <NUM>. Connector <NUM> can include a valve, a connection, a fill interface, etc., shown as valve <NUM>. Valve <NUM> can be configured to selectively fluidly couple fill channel <NUM> with inner volume <NUM> to facilitate the transport of fluid, liquid, gas, etc., to inner volume <NUM>. <FIG> shows dressing <NUM> in a deflated state (e.g., without any fluid, liquid, or gas added to inner volume <NUM>). Valve <NUM> can be configured to selectively fluidly couple with a corresponding tubular member, hose, conduit, etc., to selectively fluidly couple the corresponding tubular member with inner volume <NUM> to facilitate filling and inflating dressing <NUM>.

Referring particularly to <FIG>, dressing assembly <NUM> is shown in an inflated or filled state, according to some embodiments. In some embodiments, dressing <NUM> can be filled by selectively coupling (e.g., fluidly coupling) a fill apparatus <NUM> with valve <NUM>. Specifically, fill apparatus <NUM> (e.g., a syringe, a pump, a hose, a fill system, a pumping system including a fluid reservoir, etc.) can be fluidly coupled with inner volume <NUM> of dressing <NUM> through a tubular member <NUM>. Fill apparatus <NUM> is configured to deliver fluid, liquid, or gas (e.g., air, saline solution, a sterile liquid, etc.) to inner volume <NUM> through connector <NUM>. The fluid may flow through tubular member <NUM>, valve <NUM>, fill channel <NUM> of connector <NUM>, and enter inner volume <NUM> of dressing <NUM>, thereby inflating dressing <NUM>. Inner volume <NUM> may increase as fluid enters, thereby driving negative pressure pathway layer <NUM> and instillation pathway layer <NUM> to expand, bend, deform, etc. The fluid used to fill inner volume <NUM> and thereby inflate dressing <NUM> can be a saline solution (e.g., <NUM>% saline) which is safe in the case of leakage.

In some embodiments, valve <NUM> is a one-way valve that facilitates unidirectional flow of fluid into inner volume <NUM>. For example, valve <NUM> can be configured to allow fluid to flow in a direction such that the fluid enters inner volume <NUM>, while preventing the fluid from flowing in an opposite direction (e.g., preventing fluid from leaking out of inner volume <NUM> through valve <NUM>). Valve <NUM> can also be selectively coupled with connector <NUM> such that valve <NUM> can be removed, replaced, etc. In some embodiments, valve <NUM> can be selectively fluidly de-coupled or removed from connector <NUM> such that the fluid may exit inner volume <NUM>, thereby deflating dressing <NUM> and emptying inner volume <NUM>.

Referring particularly to <FIG>, various fluid flow paths of inflatable dressing <NUM> are shown, according to some embodiments. Instillation fluid may be provided to instillation tube <NUM> from therapy unit <NUM> through instillation tube <NUM>. The instillation fluid is transferred through instillation tube <NUM> to connector <NUM>. The instillation fluid is then transferred through instillation channel <NUM> of connector <NUM> to instillation pathway layer <NUM>. The instillation fluid is transferred, absorbed, wicked, etc., through instillation manifold <NUM> and to cavity <NUM>. Exuded wound fluid and/or instillation fluid is removed from cavity <NUM> through negative pressure pathway layer <NUM>. The exuded wound fluid and/or the instillation fluid is transferred through negative pressure manifold <NUM> to connector <NUM>. The exuded wound fluid and/or the instillation fluid is transferred through vacuum channel <NUM> to vacuum tube <NUM>, where it is then transferred to therapy unit <NUM>. The fluid may be driven to flow through negative pressure manifold <NUM>, connector <NUM>, and vacuum tube <NUM> by the negative pressure in cavity <NUM> produced by therapy unit <NUM>.

In some embodiments, only the outer film layer <NUM> of instillation pathway layer <NUM> and negative pressure pathway layer <NUM> includes perforations, openings, holes, apertures, fenestrations, etc., to fluidly couple instillation manifold <NUM> and negative pressure manifold <NUM> with cavity <NUM>. However, inner film layer <NUM> may be substantially sealed (e.g., not including perforations, holes, openings, apertures, etc.) such that the fluid within inner volume <NUM> is prevented or restricted from exiting inner volume <NUM> and entering either of instillation manifold <NUM> and negative pressure manifold <NUM>. In this way, instillation fluid or fluid within cavity <NUM> is also prevented from entering inner volume <NUM> through instillation manifold <NUM> and/or negative pressure manifold <NUM>. Advantageously, inner film layers <NUM> facilitate providing a barrier layer between negative pressure manifold <NUM> and instillation manifold <NUM> to prevent the transfer of fluid out of or into inner volume <NUM>.

In some embodiments, dressing <NUM> is inflated (e.g., by filling inner volume <NUM> with fluid) in order to preserve a shape or volume of the patient's breast, thereby reducing patient distress. Advantageously, dressing <NUM> can be used to maintain symmetry between the patients breasts (e.g., after reconstructive breast surgery, breast cancer surgery, etc.), thereby maintaining patient comfort and reducing patient distress.

Referring particularly to <FIG>, a negative pressure system <NUM> for a permanent implant <NUM> is shown, according to some embodiments not according to the invention. Negative pressure system <NUM> includes therapy unit <NUM>, instillation tube <NUM>, and vacuum tube <NUM>. Therapy unit <NUM> includes a negative pressure canister <NUM> that is configured to fluidly couple with vacuum tube <NUM> to draw a negative pressure at cavity <NUM> of a patient's breast <NUM>. Permanent implant <NUM> is positioned within cavity <NUM>. Negative pressure system <NUM> can be used to wash permanent implant <NUM> without removing implant <NUM> from cavity <NUM>. Advantageously, this allows treatment and negative pressure wound therapy application to permanent implant <NUM> without invasively removing permanent implant <NUM> which may be distressing to the patient. This is intended to reduce the infection and salvage permanent implant <NUM> without requiring the patient to have the entire permanent implant <NUM> removed.

Vacuum tube <NUM> can be fluidly coupled with cavity <NUM> at a bottom portion of cavity <NUM> through a connector <NUM>. Instillation tube <NUM> can be fluidly coupled with cavity <NUM> at an upper portion of cavity <NUM> through connector <NUM>. Therapy unit <NUM> operates to provide instillation fluid into cavity <NUM> through instillation tube <NUM> and connector <NUM> (e.g., at the upper portion of cavity <NUM>). Therapy unit <NUM> also operates to draw fluid and a negative pressure at or from cavity <NUM> through vacuum tube <NUM> and connector <NUM> at the bottom portion of cavity <NUM>. In other embodiments, vacuum tube <NUM> is fluidly coupled with cavity <NUM> at the upper portion of cavity <NUM>, while instillation tube <NUM> is fluidly coupled with cavity <NUM> at the bottom portion of cavity <NUM>.

The instillation fluid can be provided at the upper portion, and flow through cavity <NUM> between an interior facing surface of tissue at cavity <NUM> and an exterior facing surface of permanent implant <NUM>. The instillation fluid may wash, sterilize, clean, etc., tissue at or near cavity <NUM> in addition to permanent implant <NUM>. The instillation fluid and any other fluid in cavity <NUM> is then removed from cavity <NUM> through vacuum tube <NUM> and connector <NUM>. In this way, the instillation fluid can flow from the upper portion of cavity <NUM> where it is provided by negative pressure system <NUM> to the bottom portion of cavity <NUM> where is it removed. Likewise, if instillation tube <NUM> is fluidly coupled with cavity <NUM> at the bottom portion of cavity <NUM>, and vacuum tube <NUM> is fluidly coupled with cavity <NUM> at the upper portion of cavity <NUM>, the instillation fluid may flow upwards within cavity <NUM> (e.g., through a space defined between the exterior surface of the permanent implant <NUM> and the inwards or interior facing surface of cavity <NUM>).

Advantageously, negative pressure system <NUM> can be used as a minimally invasive system to provide benefits associated with negative pressure wound therapy in addition to sterilizing or cleaning cavity <NUM>, surrounding tissue, and permanent implant <NUM>. Negative pressure system <NUM> can be used to treat infected breast cavities or infected permanent implants <NUM> by providing negative pressure (e.g., through vacuum tube <NUM>) in addition to instillation fluid. Removed fluid (e.g., instillation fluid and/or exuded fluid) can be stored in negative pressure canister <NUM> until negative pressure canister <NUM> is filled. Once negative pressure canister <NUM> is substantially filled, the exuded fluid and/or the instillation fluid can be disposed.

The instillation fluid can be stored in a fluid reservoir <NUM>. Fluid reservoir <NUM> can be fluidly coupled with an instillation hanger <NUM> of therapy unit <NUM>. Instillation hanger <NUM> can include an instillation pump (e.g., a discharge pump) <NUM> that is configured to drive the instillation fluid through instillation tube <NUM>. In other embodiments, instillation hanger <NUM> does not include instillation pump <NUM> and the instillation fluid is drawn into cavity <NUM> through instillation tube <NUM> due to the negative pressure at cavity <NUM>.

Referring still to <FIG>, therapy unit <NUM> can include a vacuum pump, a negative pressure pump (e.g., a suction pump), shown as pneumatic pump <NUM>. Pneumatic pump <NUM> can be fluidly coupled with vacuum tube <NUM> and is configured to draw a negative pressure at cavity <NUM> through vacuum tube <NUM>. Pneumatic pump <NUM> can be configured to draw the negative pressure through vacuum tube <NUM> such that fluid (e.g., exuded wound fluid and/or instillation fluid) is drawn through vacuum tube <NUM> to negative pressure canister <NUM>.

Referring now to <FIG>, a negative pressure wound therapy system <NUM> is shown, according to an exemplary embodiment. System <NUM> can include various components usable with any of dressing assemblies <NUM> as described in greater detail with reference to <FIG>. System <NUM> is shown to include therapy unit <NUM> fluidly connected to dressing <NUM> via tubes <NUM> and <NUM>. Dressing <NUM> may be adhered or sealed to a patient's skin <NUM> surrounding a wound <NUM> or may be an intra-cavity dressing as described in greater detail above with reference to <FIG>. Several examples of wound dressings <NUM> which can be used in combination with system <NUM> are described in detail in <CIT>, <CIT>, and <CIT>.

Therapy unit <NUM> can be configured to provide negative pressure wound therapy by reducing the pressure at wound <NUM> or within cavity <NUM>. Therapy unit <NUM> can draw a vacuum at wound <NUM> or within cavity <NUM> (relative to atmospheric pressure) by removing wound exudate, air, and other fluids from wound <NUM>. Wound exudate may include fluid that filters from a patient's circulatory system into lesions or areas of inflammation. For example, wound exudate may include water and dissolved solutes such as blood, plasma proteins, white blood cells, platelets, and red blood cells. Other fluids removed from wound <NUM> and/or cavity <NUM> may include instillation fluid <NUM> previously delivered to wound <NUM> and/or cavity <NUM>. Instillation fluid <NUM> can include, for example, a cleansing fluid, a prescribed fluid, a medicated fluid, an antibiotic fluid, or any other type of fluid which can be delivered to wound <NUM> or cavity <NUM> during wound treatment. Instillation fluid <NUM> may be held in an instillation fluid canister <NUM> and controllably dispensed to wound <NUM> or cavity <NUM> via instillation fluid tubing <NUM>. In some embodiments, instillation fluid canister <NUM> is detachable from therapy unit <NUM> to allow canister <NUM> to be refilled and replaced as needed.

The fluids <NUM> removed from wound <NUM> or cavity <NUM> pass through vacuum tube <NUM> and are collected in removed fluid canister <NUM>. Removed fluid canister <NUM> may be a component of therapy unit <NUM> configured to collect wound exudate and other fluids <NUM> removed from wound <NUM> or cavity <NUM>. In some embodiments, removed fluid canister <NUM> is detachable from therapy unit <NUM> to allow canister <NUM> to be emptied and replaced as needed. A lower portion of canister <NUM> may be filled with wound exudate and other fluids <NUM> removed from wound <NUM> or cavity <NUM>, whereas an upper portion of canister <NUM> may be filled with air. Therapy unit <NUM> can be configured to draw a vacuum within canister <NUM> by pumping air out of canister <NUM>. The reduced pressure within canister <NUM> can be translated to dressing <NUM> and wound <NUM> or cavity <NUM> via tubing <NUM> such that dressing <NUM> and wound <NUM> or cavity <NUM> are maintained at the same pressure as canister <NUM>.

Referring particularly to <FIG>, block diagrams illustrating therapy unit <NUM> in greater detail are shown, according to an exemplary embodiment. Therapy unit <NUM> is shown to include a pneumatic pump <NUM>, an instillation pump <NUM>, a valve <NUM>, a filter <NUM>, and a controller <NUM>. Pneumatic pump <NUM> can be fluidly coupled to removed fluid canister <NUM> (e.g., via conduit <NUM>) and can be configured to draw a vacuum within canister <NUM> by pumping air out of canister <NUM>. In some embodiments, pneumatic pump <NUM> is configured to operate in both a forward direction and a reverse direction. For example, pneumatic pump <NUM> can operate in the forward direction to pump air out of canister <NUM> and decrease the pressure within canister <NUM>. Pneumatic pump <NUM> can operate in the reverse direction to pump air into canister <NUM> and increase the pressure within canister <NUM>. Pneumatic pump <NUM> can be controlled by controller <NUM>, described in greater detail below.

Similarly, instillation pump <NUM> can be fluidly coupled to instillation fluid canister <NUM> via tubing <NUM> and fluidly coupled to dressing <NUM> via tubing <NUM>. Instillation pump <NUM> can be operated to deliver instillation fluid <NUM> to dressing <NUM> and wound <NUM> (or cavity <NUM>) by pumping instillation fluid <NUM> through tubing <NUM> and tubing <NUM>, as shown in <FIG>. Instillation pump <NUM> can be controlled by controller <NUM>, described in greater detail below.

Filter <NUM> can be positioned between removed fluid canister <NUM> and pneumatic pump <NUM> (e.g., along conduit <NUM>) such that the air pumped out of canister <NUM> passes through filter <NUM>. Filter <NUM> can be configured to prevent liquid or solid particles from entering conduit <NUM> and reaching pneumatic pump <NUM>. Filter <NUM> may include, for example, a bacterial filter that is hydrophobic and/or lipophilic such that aqueous and/or oily liquids will bead on the surface of filter <NUM>. Pneumatic pump <NUM> can be configured to provide sufficient airflow through filter <NUM> that the pressure drop across filter <NUM> is not substantial (e.g., such that the pressure drop will not substantially interfere with the application of negative pressure to wound <NUM> (or cavity <NUM>) from therapy unit <NUM>).

In some embodiments, therapy unit <NUM> operates a valve <NUM> to controllably vent the negative pressure circuit, as shown in <FIG>. Valve <NUM> can be fluidly connected with pneumatic pump <NUM> and filter <NUM> via conduit <NUM>. In some embodiments, valve <NUM> is configured to control airflow between conduit <NUM> and the environment around therapy unit <NUM>. For example, valve <NUM> can be opened to allow airflow into conduit <NUM> via vent <NUM> and conduit <NUM>, and closed to prevent airflow into conduit <NUM> via vent <NUM> and conduit <NUM>. Valve <NUM> can be opened and closed by controller <NUM>, described in greater detail below. When valve <NUM> is closed, pneumatic pump <NUM> can draw a vacuum within a negative pressure circuit by causing airflow through filter <NUM> in a first direction, as shown in <FIG>. The negative pressure circuit may include any component of system <NUM> that can be maintained at a negative pressure when performing negative pressure wound therapy (e.g., conduit <NUM>, removed fluid canister <NUM>, tubing <NUM>, dressing <NUM>, cavity <NUM>, and/or wound <NUM>). For example, the negative pressure circuit may include conduit <NUM>, removed fluid canister <NUM>, tubing <NUM>, dressing <NUM>, cavity <NUM>, and/or wound <NUM>. When valve <NUM> is open, airflow from the environment around therapy unit <NUM> may enter conduit <NUM> via vent <NUM> and conduit <NUM> and fill the vacuum within the negative pressure circuit. The airflow from conduit <NUM> into canister <NUM> and other volumes within the negative pressure circuit may pass through filter <NUM> in a second direction, opposite the first direction, as shown in <FIG>.

In some embodiments, therapy unit <NUM> vents the negative pressure circuit via an orifice <NUM>, as shown in <FIG>. Orifice <NUM> may be a small opening in conduit <NUM> or any other component of the negative pressure circuit (e.g., removed fluid canister <NUM>, tubing <NUM>, tubing <NUM>, dressing <NUM>, etc.) and may allow air to leak into the negative pressure circuit at a known rate. In some embodiments, therapy unit <NUM> vents the negative pressure circuit via orifice <NUM> rather than operating valve <NUM>. Valve <NUM> can be omitted from therapy unit <NUM> for any embodiment in which orifice <NUM> is included. The rate at which air leaks into the negative pressure circuit via orifice <NUM> may be substantially constant or may vary as a function of the negative pressure, depending on the geometry of orifice <NUM>.

In some embodiments, therapy unit <NUM> includes a variety of sensors. For example, therapy unit <NUM> is shown to include a pressure sensor <NUM> configured to measure the pressure within canister <NUM> and/or the pressure at dressing <NUM> or cavity <NUM> or wound <NUM>. In some embodiments, therapy unit <NUM> includes a pressure sensor <NUM> configured to measure the pressure within tubing <NUM>. Tubing <NUM> may be connected to dressing <NUM> and may be dedicated to measuring the pressure at dressing <NUM> or wound <NUM> or cavity <NUM> without having a secondary function such as channeling installation fluid <NUM> or wound exudate. In various embodiments, tubing <NUM>, <NUM>, and <NUM> may be physically separate tubes or separate lumens within a single tube that connects therapy unit <NUM> to dressing <NUM>. Accordingly, tubing <NUM> may be described as a negative pressure lumen that functions apply negative pressure dressing <NUM> or wound <NUM> or cavity <NUM>, whereas tubing <NUM> may be described as a sensing lumen configured to sense the pressure at dressing <NUM> or wound <NUM> or cavity <NUM>. Pressure sensors <NUM> and <NUM> can be located within therapy unit <NUM>, positioned at any location along tubing <NUM>, <NUM>, and <NUM>, or located at dressing <NUM> in various embodiments. Pressure measurements recorded by pressure sensors <NUM> and/or <NUM> can be communicated to controller <NUM>. Controller <NUM> use the pressure measurements as inputs to various pressure testing operations and control operations performed by controller <NUM>.

Controller <NUM> can be configured to operate pneumatic pump <NUM>, instillation pump <NUM>, valve <NUM>, and/or other controllable components of therapy unit <NUM>. For example, controller <NUM> may instruct valve <NUM> to close and operate pneumatic pump <NUM> to establish negative pressure within the negative pressure circuit. Once the negative pressure has been established, controller <NUM> may deactivate pneumatic pump <NUM>. Controller <NUM> may cause valve <NUM> to open for a predetermined amount of time and then close after the predetermined amount of time has elapsed.

In some embodiments, therapy unit <NUM> includes a user interface <NUM>. User interface <NUM> may include one or more buttons, dials, sliders, keys, or other input devices configured to receive input from a user. User interface <NUM> may also include one or more display devices (e.g., LEDs, LCD displays, etc.), speakers, tactile feedback devices, or other output devices configured to provide information to a user. In some embodiments, the pressure measurements recorded by pressure sensors <NUM> and/or <NUM> are presented to a user via user interface <NUM>. User interface <NUM> can also display alerts generated by controller <NUM>. For example, controller <NUM> can generate a "no canister" alert if canister <NUM> is not detected.

In some embodiments, therapy unit <NUM> includes a data communications interface <NUM> (e.g., a USB port, a wireless transceiver, etc.) configured to receive and transmit data. Communications interface <NUM> may include wired or wireless communications interfaces (e.g., jacks, antennas, transmitters, receivers, transceivers, wire terminals, etc.) for conducting data communications external systems or devices. In various embodiments, the communications may be direct (e.g., local wired or wireless communications) or via a communications network (e.g., a WAN, the Internet, a cellular network, etc.). For example, communications interface <NUM> can include a USB port or an Ethernet card and port for sending and receiving data via an Ethernet-based communications link or network. In another example, communications interface <NUM> can include a Wi-Fi transceiver for communicating via a wireless communications network or cellular or mobile phone communications transceivers.

Referring now to <FIG>, a process <NUM> for using dressing assembly <NUM> as described in greater detail above with reference to <FIG>, according to some embodiments not according to the invention. Process <NUM> includes steps <NUM>-<NUM> and can be used to provide negative pressure wound therapy and instillation fluid to a breast cavity. Process <NUM> can be performed by a clinician, a caregiver, etc..

Process <NUM> includes providing a dressing with a negative pressure pathway layer and an instillation pathway layer (step <NUM>), according to some embodiments. The negative pressure pathway layer may include a negative pressure manifold that is positioned between inner and outer film layers. The instillation pathway layer can include an instillation manifold that is positioned between inner and outer film layers. The inner and outer film layers of both the negative pressure pathway layer and the instillation pathway layer can be sealed with each other. The inner and/or the outer film layers may include perforations, openings, holes, apertures, fenestrations, etc., so that fluid passing through the manifolds can be transferred into or out of the breast cavity. Step <NUM> can be performed by a caregiver or a technician. The instillation pathway layer and the negative pressure pathway layer may each be fixedly coupled at a proximate end with a connector, and may have a free distal end.

Process <NUM> includes providing a space filler within an inner volume defined between the negative pressure pathway layer and the instillation pathway layer (step <NUM>), according to some embodiments. In some embodiments, the space filler is a breast expander, or any other medical object, implant, gauze, felt, etc., that can be positioned within the inner volume to facilitate filling the patient's breast cavity. The negative pressure pathway layer and the instillation pathway layer can be wrapped around the space filler (e.g., by a technician or a caregiver or a surgeon). For example, the free distal ends may be wrapped around the space filler.

Process <NUM> includes implanting the dressing with the space filler into the patient's breast cavity (step <NUM>), according to some embodiments. Step <NUM> can be performed by a surgeon, a caregiver, a medical professional, etc. The dressing can be implanted into the patient's breast cavity with the space filler positioned between the negative pressure pathway layer and the instillation pathway layer. Exterior or outer surfaces of the outer film layers of the negative pressure pathway layer and the instillation pathway layer can directly contact or engage an interior facing surface of the patient's breast cavity (e.g., inwards facing tissue).

Process <NUM> includes fluidly coupling a vacuum tube and an instillation tube with the negative pressure pathway layer and the instillation pathway layer (step <NUM>), according to some embodiments. The vacuum tube and the instillation tube can be fluidly coupled with the negative pressure pathway layer and the instillation pathway layer through a connector that fluidly couples with the manifolds (e.g., the negative pressure manifold and the instillation manifold) through different channels. In this way, instillation fluid can be independently provided to the instillation manifold of the instillation pathway layer and wound fluid can be independently removed through the negative pressure manifold of the negative pressure pathway layer. Step <NUM> can be performed by a caregiver. The caregiver may fluidly couple the vacuum tube and the instillation tube with the connector so that negative pressure wound therapy can be performed.

Process <NUM> includes fluidly coupling the vacuum tube and the instillation tube with a therapy unit (step <NUM>), according to some embodiments. Step <NUM> may be performed by a caregiver, a technician, a surgeon, etc. Step <NUM> can be performed by fluidly coupling or removably coupling the vacuum tube and the instillation tube with corresponding connection portions of the therapy unit.

Process <NUM> includes operating the therapy unit to draw a negative pressure within the patient's breast cavity through the vacuum tube and the negative pressure pathway layer (step <NUM>), according to some embodiments. Step <NUM> can be performed by the therapy unit. The therapy unit may include a controller, a power source, and a pneumatic pump configured to operatively draw a negative pressure. The pneumatic pump can be fluidly coupled or configured to draw the negative pressure within the cavity through the vacuum tube. For example, the pneumatic pump can be fluidly coupled with the vacuum tube such that negative pressure drawn at the vacuum tube is transferred to the patient's breast cavity.

Process <NUM> includes operating the therapy unit to provide instillation fluid to the patient's breast cavity through the instillation tube (step <NUM>), according to some embodiments. In some embodiments, step <NUM> is performed concurrently with step <NUM>. For example, the instillation fluid may be provided to the patient's breast cavity while the negative pressure is drawn at the patient's breast cavity. The therapy unit may include an instillation pump (e.g., a discharge pump) and a fluid reservoir that contains the instillation fluid. The instillation pump can be operated by the controller to provide the instillation fluid from the fluid reservoir to the instillation tube. The instillation fluid is driven through the instillation tube, through the connector, and to the instillation manifold that is positioned between the film layers. The instillation fluid can be absorbed or transferred through the instillation manifold and may exit through the holes in either of the film layers to the patient's breast cavity. In some embodiments, the flow of the instillation fluid into the patient's breast cavity is facilitated by the negative pressure produced within the breast cavity by the pneumatic pump.

Process <NUM> can also include reversing a direction of fluid removal/fluid delivery and repeating steps <NUM>-<NUM> (step <NUM>), according to some embodiments. Step <NUM> can be performed by adjusting or operating the connector to cross-plumb the instillation tube and the vacuum tube. In this way, the instillation manifold can be used to draw the negative pressure within the cavity (e.g., by performing step <NUM> with the direction reversed) and the negative pressure manifold can be used to provide instillation fluid to the cavity. The direction that fluid is added/removed to/from the cavity can be reversed by operating or cross-plumbing the connector.

Referring now to <FIG>, a process <NUM> for using the inflatable dressing <NUM> as described in greater detail above with reference to <FIG> is shown, according to some embodiments not according to the invention. Process <NUM> includes steps <NUM>-<NUM>, according to some embodiments. Process <NUM> can be performed by a technician, a surgeon, a caregiver, etc..

Process <NUM> includes providing a dressing including a negative pressure pathway layer, and an instillation pathway layer that cooperatively form or define a sealed inner volume (step <NUM>), according to some embodiments. In some embodiments, the dressing is the same as or similar to the dressing <NUM> or the dressing assembly <NUM> as described in greater detail above with reference to <FIG>. The negative pressure pathway layer and the instillation pathway layer can each include a manifold (e.g., a negative pressure manifold and an instillation manifold) that are positioned between an inner film layer and an outer film layer. In some embodiments, the outer film layer includes various openings, holes, apertures, perforations, fenestrations, etc., that fluidly couple the manifolds with a breast cavity in which the dressing can be implanted. The inner film layers of the negative pressure pathway layer and the instillation pathway layer may be continuous (e.g., not including any perforations or holes) to facilitate ensuring that fluid in the inner volume does not leak out.

Process <NUM> includes implanting the dressing with the negative pressure pathway layer and the instillation pathway layer in a deflated or non-filled state to a patient's breast cavity (step <NUM>), according to some embodiments. In some embodiments, the dressing is implanted into the patient's breast cavity without any fluid present in the inner volume defined by the negative pressure pathway layer and the instillation pathway layer. In this state, the dressing may have a smaller size than when the dressing is filled with fluid. The dressing may have the form of a compressible or inflatable bladder, balloon, etc. Step <NUM> can be performed by a technician, a caregiver, a surgeon, etc., or any other medical professional.

Process <NUM> includes fluidly coupling a vacuum tube, an instillation tube, and a fill tube with a connector of the dressing (step <NUM>), according to some embodiments. The vacuum tube, the instillation tube, and the fill tube can be fluidly coupled with different channels of the connector. The vacuum tube can be fluidly coupled with the negative pressure manifold that is positioned between the film layers of the negative pressure pathway layer. The instillation tube can be fluidly coupled with the instillation manifold that is positioned between the film layers of the instillation pathway layer. The fill tube can be fluidly coupled with a valve at the connector (e.g., one-way valve) so that the fill tube is fluidly coupled with the inner volume of the dressing defined between the instillation pathway layer and the negative pressure pathway layer. Step <NUM> can be performed by a technician, a caregiver, etc., after the dressing has been implanted in the patient's breast cavity.

Process <NUM> includes operating a fluid delivery device to provide a fluid to the inner volume through the fill tube and the connector to fill the dressing and transition the dressing into a filled or partially filled state (step <NUM>), according to some embodiments. Step <NUM> can be performed by a caregiver, a technician, a surgeon, etc. The fluid delivery device can be a syringe, a pump, etc., or any other device configured to pressure a fluid (e.g., a liquid or a gas) to drive the fluid into the inner volume of the dressing. The technician or the caregiver or the surgeon can operate the fluid delivery device until the dressing is filled to a desired state.

Process <NUM> includes fluidly coupling the instillation tube and the vacuum tube with a therapy unit (step <NUM>), according to some embodiments. In some embodiments, step <NUM> is the same as or similar to step <NUM> of process <NUM> as described in greater detail above with reference to <FIG>.

Process <NUM> includes operating the therapy unit to draw a negative pressure within the patient's breast cavity through the vacuum tube and the negative pressure pathway layer (step <NUM>) and operating the therapy unit to provide instillation fluid to the patient's breast cavity through the instillation tube (step <NUM>), according to some embodiments. Steps <NUM> and <NUM> can be the same as or similar to steps <NUM> and <NUM> of process <NUM> as described in greater detail above with reference to <FIG>.

Referring now to <FIG>, a process <NUM> for treating a permanent implant is shown, according to some embodiments not according to the invention. Process <NUM> includes steps <NUM>-<NUM>, according to some embodiments. Process <NUM> can be performed by a technician, a caregiver, a surgeon, etc. In some embodiments, process <NUM> is performed with negative pressure system <NUM>.

Process <NUM> includes providing an instillation tube that fluidly couples at an upper portion of a patient's breast cavity (step <NUM>), according to some embodiments. The instillation tube can be configured to deliver instillation fluid (e.g., a saline solution, a sterile solution, etc.) to the patient's breast cavity. The instillation tube can be provided and fluidly coupled with the upper portion of the patient's breast cavity by a surgeon, a medical professional, etc. The instillation tube may be surgically inserted so that an open end of the instillation tube fluidly couples with the upper portion of the patient's breast cavity. A permanent implant may be positioned within the patient's breast cavity, and the instillation tube can be configured to deliver or provide instillation fluid to the patient's breast cavity while the permanent implant is present. The instillation tube can be surgically inserted or fluidly coupled with the patient's breast cavity while the permanent implant is present and without removing (e.g., surgically) the permanent implant.

Process <NUM> includes providing a vacuum tube that fluidly couples at a lower portion of a patient's breast cavity (step <NUM>), according to some embodiments. The vacuum tube can be inserted, surgically implanted, etc., at the lower portion of the patient's breast cavity. The vacuum tube can be configured to draw a negative pressure within the patient's breast cavity in addition to drawing out exuded fluid (e.g., wound fluid) or instillation fluid from the patient's breast cavity. The vacuum tube can be provided and fluidly coupled with the lower portion of the patient's breast cavity by a surgeon, a medical professional, etc. The vacuum tube may be surgically inserted so that an open end of the vacuum tube fluidly couples with the lower portion of the patient's breast cavity. The vacuum tube can be inserted while the permanent implant is still present within the patient's breast cavity, without requiring removal of the permanent implant. The vacuum tube can be configured to draw fluid from between an interior surface of the patient's breast cavity and an exterior surface of the permanent implant.

Process <NUM> includes fluidly coupling the vacuum tube and the instillation tube with a therapy unit (step <NUM>), according to some embodiments. The therapy unit can include a pneumatic pump configured to fluidly couple with the vacuum tube and draw a negative pressure at the patient's breast cavity. The therapy unit may also include an instillation pump that is configured to drive or deliver instillation fluid from the therapy unit to the patient's breast cavity through the instillation tube. Step <NUM> can be performed by a medical professional, a caregiver, a surgeon, etc. The instillation tube and the vacuum tube can be removably fluidly coupled with the therapy unit.

Process <NUM> includes operating the therapy unit to draw a negative pressure within the patient's breast cavity through the vacuum tube and the negative pressure pathway layer (step <NUM>), according to some embodiments. The negative pressure may be drawn at the patient's breast cavity by operating the pneumatic pump that is fluidly coupled with the vacuum tube. In some embodiments, the therapy unit includes a controller that is configured to operate the pneumatic pump to draw the negative pressure. The negative pressure at the patient's breast cavity may originate at the bottom portion of the patient's breast cavity where the vacuum tube is fluidly coupled.

Process <NUM> includes operating the therapy unit to provide instillation fluid to the patient's breast cavity through the instillation tube (step <NUM>), according to some embodiments. The instillation pump can be operated to drive instillation fluid through the instillation tube to the patient's breast cavity. The instillation fluid is provided into the patient's breast cavity at the upper portion of the patient's breast cavity. Steps <NUM> can be performed concurrently with each other. The instillation fluid may also be driven to enter the patient's breast cavity from the therapy unit due to the negative pressure drawn within the patient's breast cavity by the pneumatic pump. The instillation fluid may be provided to the patient's breast cavity at the upper portion of the patient's breast cavity, flow along a space defined between the exterior surface of the permanent implant and the interior surface of the breast cavity, and be removed through the vacuum tube at the bottom portion of the patient's breast cavity.

Referring particularly to <FIG>, a temporary breast implant <NUM> is usable with any of the dressings, systems, etc., described in greater detail above with reference to <FIG>. Temporary breast implant <NUM> can be implanted into a patient's breast cavity for temporary and/or permanent applications. Temporary breast implant <NUM> can include various layers <NUM> of filler material. Layers <NUM> may be removably coupled with adjacent layers so that an outermost layer can be peeled off and so that temporary breast implant <NUM> can be shaped, formed, re-shaped, re-sized, etc., as desired. Layers <NUM> can be a foam material (e.g., V. ® GRANUFOAM™) that are molded to each other to create a foam implant shaped wound filler. In the case of an infected breast implant, temporary breast implant <NUM> can be shaped similar to that of a typical breast expander (used to stretch breast skin post mastectomy). Layers <NUM> can be peeled away to resize temporary breast implant <NUM> until temporary breast implant <NUM> is a desired or required size (e.g., so that it is the same size as an implant being removed). In some embodiments, temporary breast implant <NUM> may shrink under negative pressure. Temporary breast implant <NUM> can be sized so that it is slightly larger than required, thereby accounting for shrinkage that occurs when negative pressure is applied and thereby ensuring that the patient's breasts will be symmetrical during therapy.

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 invention as recited in the appended claims.

It should be noted that the terms "exemplary" and "example" as used herein to describe various embodiments is intended to indicate that such embodiments are possible examples, representations, and/or illustrations of possible embodiments (and such term is not intended to connote that such embodiments are necessarily extraordinary or superlative examples).

The terms "coupled," "connected," and the like, as used herein, mean the joining of two members directly or indirectly to one another. Such joining may be stationary (e.g., permanent, etc.) or moveable (e.g., removable, releasable, etc.). Such joining may be achieved with the two members or the two members and any additional intermediate members being integrally formed as a single unitary body with one another or with the two members or the two members and any additional intermediate members being attached to one another.

References herein to the positions of elements (e.g., "first", "second", "primary," "secondary," "above," "below," "between," etc.) are merely used to describe the orientation of various elements in the figures.

Claim 1:
A dressing for an internal cavity, the dressing comprising:
a connector;
a negative pressure pathway layer coupled with the connector at a first portion of the negative pressure pathway layer, wherein a portion of the negative pressure pathway layer is substantially free;
an instillation pathway layer coupled with the connector at a first portion of the instillation pathway layer, wherein a portion of the instillation pathway layer is substantially free;
a negative pressure manifold disposed within the negative pressure pathway layer, wherein a first portion of the negative pressure manifold is fluidly coupled with a first channel of the connector; and
an instillation manifold disposed within the instillation pathway layer, wherein a portion of the instillation manifold is fluidly coupled with a second channel of the connector;
wherein the negative pressure pathway layer and the instillation pathway layer are sealed along one or more portions of a perimeter of the negative pressure pathway layer and a perimeter of the instillation pathway layer and are configured to cooperatively form an inner volume therebetween, wherein the inner volume is configured to receive a space filler; and
wherein the negative pressure pathway layer, the instillation pathway layer, and the space filler are collectively configured to be positioned within the internal cavity.