Patent Description:
The invention set forth in the appended claims relates generally to tissue treatment systems and more particularly, but without limitation, to systems and methods (not claimed) for providing negative-pressure therapy and/or instillation of the tissue site. An example of a prior art device is disclosed in <CIT>.

There is also widespread acceptance that cleansing a tissue site can be highly beneficial for new tissue growth. For example, a wound or a cavity can be washed out with a liquid solution for therapeutic purposes. These practices are commonly referred to as "irrigation" and "lavage" respectively. "Instillation" is another practice that generally refers to a process of slowly introducing fluid to a tissue site and leaving the fluid for a prescribed period of time before removing the fluid. For example, instillation of topical treatment solutions over a wound bed can be combined with negative-pressure therapy to further promote wound healing by loosening soluble contaminants in a wound bed and removing infectious material. As a result, soluble bacterial burden can be decreased, contaminants removed, and the wound cleansed.

While the clinical benefits of negative-pressure therapy and/or instillation therapy are widely known, improvements to therapy systems, components, and processes may benefit healthcare providers and patients.

The methods do not form part of the invention as claimed. Useful systems, apparatuses, and methods for treating tissue in a negative-pressure therapy environment are set forth in the disclosure. Illustrative embodiments are provided to enable a person skilled in the art to make and use the claimed subject matter.

For example, some embodiments may relate to negative-pressure therapy, which may collect exudate from one or more tissue sites. In some embodiments, a multi-canister module may allow a single negative-pressure source to draw exudate from one or more tissue sites into two or more canisters during negative-pressure therapy. In some embodiments, pressure sensing may take place alongside negative-pressure treatment, for example through one or both canisters. In some embodiments, the module may allow for one of the canisters to be changed without interrupting negative-pressure therapy and/or pressure-sensing at the tissue site. For example, the fluid connection between each canister and the module may be configured to close when the canister is not coupled to the module, but to be open when the canister is coupled to the module. Some embodiments may further comprise a therapy unit adapter, which may be configured to retrofit negative-pressure therapy units designed for use with a single canister to interact with the multi-canister module, so that more than one canister may be used with the single therapy unit. Some embodiments may further comprise a branch adapter, which may be configured to common-together the negative-pressure and/or the pressure-sensing pathways from the two or more canisters, for example allowing multiple canisters to be used with a single dressing to collect exudate from a single tissue site.

Some example embodiments of a device for fluidly coupling multiple canisters to a single negative-pressure source comprise according to the invention as claimed: an input negative-pressure port configured to be fluidly coupled to the negative-pressure source; a therapy pressure-sensing port configured to be fluidly coupled to a pressure sensor (e.g. which may be external to the device, such as in a separate therapy unit); a first receptor (comprising according to the invention as claimed a releasable latch mechanism) configured for removable attachment of a first canister; a second receptor (comprising according to the invention as claimed a releasable latch mechanism) configured for removable attachment of a second canister; a first negative-pressure port fluidly coupled to the input negative-pressure port; a first pressure-sensing port fluidly coupled to the therapy pressure-sensing port; and a second negative-pressure port fluidly coupled to the input negative-pressure port. According to the invention as claimed, the first negative-pressure port and the second negative-pressure port both fluidly couple to the input negative-pressure port, such that negative-pressure from the input negative-pressure port is distributed to the first negative-pressure port and the second negative-pressure port. In some embodiments, the second negative-pressure port may comprise a valve (e.g. a sealing valve) that is biased closed but configured to open by attachment of the second canister. According to the invention as claimed, the second receptor comprising the second releasable latch mechanism is configured so that, when the second canister is attached, the second negative-pressure port is open; but when the second canister is not attached, the second negative-pressure port is closed. In some embodiments, the first releasable latch mechanism may be configured so that, when the first canister is attached, the first negative-pressure port and the first pressure-sensing port are open; but when the first canister is not attached, the first negative-pressure port and the first pressure-sensing port are closed.

Some device embodiments may further comprise a second pressure-sensing port. In some embodiments, the first negative-pressure port and the first pressure-sensing port may each comprise a valve (e.g. a sealing valve) that is biased closed, but configured to open by attachment of the first canister; and the second pressure-sensing port and the second negative-pressure port may each comprise a valve (e.g. a sealing valve) that is biased closed, but configured to open by attachment of the second canister. In some embodiments, the first pressure-sensing port and the second pressure-sensing port may both fluidly couple to the therapy pressure-sensing port, such that the therapy pressure-sensing port receives an average pressure from the first pressure-sensing port and the second pressure-sensing port. Some embodiments may further comprise an internal pressure sensor (e.g. within the device) and a wireless transmitter. In some embodiments, the internal pressure sensor may be fluidly coupled to the second pressure-sensing port and may be configured to communicate with the wireless transmitter.

Some embodiments may further comprise a therapy unit adapter configured to fluidly couple the input negative-pressure port and the therapy pressure-sensing port to the therapy unit. In some embodiment, the therapy unit may comprise the negative-pressure source, the pressure sensor, and a controller configured to operate the negative-pressure source based at least partially on sensed pressure from the pressure sensor. Some embodiments further comprise a branch adapter configured to be fluidly coupled to the first canister by a first two-pathway conduit and configured to be fluidly coupled to the second canister by a second two-pathway conduit. In some embodiments, the branch adapter may fluidly couple both the first two-pathway conduit and second two-pathway conduit to a third (e.g. output) two-pathway conduit. In some embodiments, each two-pathway conduit may comprise a negative-pressure pathway and a pressure-sensing pathway; and the negative-pressure pathways may all be fluidly isolated from the pressure-sensing pathways. In some embodiments, the negative-pressure pathway of the first two-pathway conduit and the negative-pressure pathway of the second two-pathway conduit may be fluidly coupled by the branch adapter to the negative-pressure pathway of the third (e.g. output) two-pathway conduit; and the pressure-sensing pathway of the first two-pathway conduit and the pressure-sensing pathway of the second two-pathway conduit may be fluidly coupled by the branch adapter to the pressure-sensing pathway of the third two-pathway conduit. In some embodiments, the branch adapter may comprise branch valves configured to be open under negative-pressure but to close in the absence of negative-pressure.

In some embodiments, the branch adapter may be configured to be fluidly coupled to the first canister by the first two-pathway conduit and fluidly coupled to the second canister by a negative-pressure conduit, and the branch adapter may be configured to fluidly couple the negative-pressure conduit and a negative-pressure pathway of the first two-pathway conduit to a negative-pressure pathway of an output two-pathway conduit, and to fluidly couple a pressure-sensing pathway of the first two-pathway conduit to a pressure-sensing pathway of the output two-pathway conduit. In some embodiments, the first negative-pressure port and the second negative-pressure port may be fluidly isolated from the first pressure-sensing port. In some embodiments, the first negative-pressure port and the second negative-pressure port may be fluidly isolated from the first pressure-sensing port and the second pressure-sensing port. In some embodiments, a fluid flowpath from the input negative-pressure port may divide and fluidly couple to both the first negative-pressure port and the second negative-pressure port.

Some example embodiments of a multi-canister module, which may allow more than one canister to be used to collect exudate during negative-pressure therapy, may comprise: an input negative-pressure port configured to receive negative pressure from a negative-pressure source; a therapy pressure-sensing port configured to be fluidly coupled to an external pressure sensor (e.g. from a therapy unit); a first releasable latch mechanism configured for removable attachment of a first canister, wherein the first canister has a first pathway configured for negative pressure transmission and a second pathway configured for pressure-sensing; a second releasable latch mechanism configured for removable attachment of a second canister, wherein the second canister has a third pathway configured for negative pressure transmission and a fourth pathway configured for pressure-sensing; a first negative-pressure port configured to fluidly couple the first pathway to the input negative-pressure port while the first canister is attached in fluid communication with the first negative-pressure port; a first pressure-sensing port configured to fluidly couple the second pathway to the therapy pressure-sensing port while the first canister is attached in fluid communication with the first pressure-sensing port; a second negative-pressure port configured to fluidly couple the third pathway to the input negative-pressure port while the second canister is attached in fluid communication with the second negative-pressure port; and a second pressure-sensing port configured to fluidly couple to the fourth pathway of the second canister. In some embodiments, the first releasable latch mechanism may be configured so that, when the first canister is attached, the first negative-pressure port and the first pressure-sensing port are open; but when the first canister is not attached, the first negative-pressure port and the first pressure-sensing port are closed. In some embodiments, the second releasable latch mechanism may be configured so that, when the second canister is attached, the second negative-pressure port and the second pressure-sensing port are open; but when the second canister is not attached, the second negative-pressure port and the second pressure-sensing port are closed. In some embodiments, the first pressure-sensing port and the second pressure-sensing port may both fluidly couple to the therapy pressure-sensing port, such that the therapy pressure-sensing port receives an average pressure from the first pressure-sensing port and the second pressure-sensing port. Some embodiments of the multi-canister module may further comprise an internal pressure sensor and a transmitter (e.g. a wireless transmitter), and the internal pressure sensor may be fluidly coupled to the second pressure-sensing port and may be configured to communicate with the transmitter.

Some example embodiments of a kit, which may be used to retrofit a single therapy unit that was originally configured for use with only a single canister to instead be used with two or more canisters, may comprise: a multi-canister module; and a therapy unit adapter configured to fluidly couple the multi-canister module to the therapy unit. In some embodiments, the multi-canister module may comprise: an input negative-pressure port configured to be fluidly coupled to a negative-pressure source (e.g. of the therapy unit); a therapy pressure-sensing port configured to be fluidly coupled to a pressure sensor (e.g. which may be external to the multi-canister module, for example within the therapy unit); a first releasable latch mechanism configured for removable attachment of a first canister; a second releasable latch mechanism configured for removable attachment of a second canister; a first negative-pressure port fluidly coupled to the input negative-pressure port; a first pressure-sensing port fluidly coupled to the therapy pressure-sensing port; and a second negative-pressure port fluidly coupled to the input negative-pressure port. In some embodiments, the therapy unit adapter may be configured to fluidly couple the input negative-pressure port and the therapy pressure-sensing port to the therapy unit having the negative-pressure source, the pressure sensor, and a controller configured to operate the negative-pressure source based at least partially on sensed pressure from the pressure sensor.

Some embodiments of the kit may further comprise the first canister configured for attachment to the multi-canister module via the first releasable latch mechanism and for independent fluid communication with the first negative-pressure port and with the first pressure-sensing port; and the second canister configured for attachment to the multi-canister module via the second releasable latch mechanism and for fluid communication with the second negative-pressure port. In some embodiments, the multi-canister module may further comprise a second pressure-sensing port; and the second canister may further be configured for fluid communication with the second pressure sensing port. In some embodiments, the first negative-pressure port, the first pressure-sensing port, the second negative-pressure port, and/or the second pressure-sensing port may be configured so that, when the corresponding canister is attached, the corresponding port is open; but when the corresponding canister is not attached, the corresponding port is closed. Some embodiments of the kit may further comprise a branch adapter having a first conduit coupler, a second conduit coupler, and a third conduit coupler; wherein: the first conduit coupler may comprise a first negative-pressure pathway and a first pressure-sensing pathway; the second conduit coupler may comprise a second negative-pressure pathway; and the third conduit coupler may comprise a third (e.g. output) negative-pressure pathway and a third (e.g. output) pressure-sensing pathway. In some embodiments, the first negative-pressure pathway and second negative-pressure pathway both may fluidly couple to the third (e.g. output) negative-pressure pathway; and the first pressure-sensing pathway may fluidly couple to the third (e.g. output) pressure-sensing pathway. In some embodiments, the second conduit coupler may further comprise a second pressure-sensing pathway; and the second pressure-sensing pathway may also couple to the output pressure-sensing pathway.

Some example embodiments of a system for providing negative-pressure therapy to one or more tissue sites may comprise a therapy unit and a multi-canister module. In some embodiments, the therapy unit may comprise: a negative-pressure source; a pressure sensor; and a controller. In some embodiments, the therapy unit may be configured to attach to only a single canister. For example, the therapy unit may comprise only one negative-pressure output port and only one pressure-sensing input port. In some embodiments, the multi-canister module may comprise: an input negative-pressure port configured to be fluidly coupled to a negative-pressure source (e.g. via the negative-pressure output port in the therapy unit); a therapy pressure-sensing port configured to be fluidly coupled to the pressure sensor (e.g. via the pressure-sensing input port in the therapy unit); a first releasable latch mechanism configured for removable attachment of a first canister; a second releasable latch mechanism configured for removable attachment of a second canister; a first negative-pressure port fluidly coupled to the input negative-pressure port; a first pressure-sensing port fluidly coupled to the therapy pressure-sensing port; and a second negative-pressure port fluidly coupled to the input negative-pressure port. In some embodiments, the controller may be configured to operate the negative-pressure source for negative-pressure therapy at least partially based on communication with the pressure sensor. In some embodiments, the therapy unit may further comprise only the single negative-pressure output port, only the single pressure-sensing input port, and a unit releasable latch mechanism configured to allow a single canister (e.g. with a two-pathway conduit, one for negative pressure and one for sensed pressure) to be attached to the therapy unit. In some embodiments, each of the first and second releasable latch mechanisms may be substantially identical to the unit releasable latch mechanism.

Some embodiments of the system may further comprise a therapy unit adapter configured to fluidly couple the input negative-pressure port of the multi-canister module to the negative-pressure output port of the therapy unit, and to couple the therapy pressure-sensing port of the multi-canister module to the pressure-sensing input port of the therapy unit. Some embodiments of the system may further comprise the first canister and the second canister. In some embodiments, the first canister may be configured to attach to the multi-canister module via the first releasable latch mechanism and to fluidly couple to the first negative-pressure port and the first pressure-sensing port; and the second canister may be configured to attach to the multi-canister module via the second releasable latch mechanism and to fluidly couple to at least the second negative-pressure port. In some embodiments, the multi-canister module may further comprise a second pressure-sensing port, and the second canister may be configured to couple to both the second negative-pressure port and the second pressure-sensing port. In some embodiments, the first negative-pressure port, the first pressure-sensing port, the second negative-pressure port, and/or the second pressure-sensing port may be configured so that, when the corresponding canister is attached, the corresponding port is open; but when the corresponding canister is not attached, the corresponding port is closed. Some embodiments of the system may further comprise a branch adapter configured to be fluidly coupled to the first canister by a first two-pathway conduit, and configured to be fluidly coupled to the second canister by a second two-pathway conduit. In some embodiments, the branch adapter may fluidly couple both the first two-pathway conduit and second two-pathway conduit to a third (e.g. output) two-pathway conduit. In some embodiments, each two-pathway conduit may comprise a negative-pressure pathway and a pressure-sensing pathway, and all of the negative-pressure pathways may be fluidly isolated from all of the pressure-sensing pathways.

Some example embodiments of a branch adapter, which may be configured to fluidly couple a first canister and a second canister to a single dressing, may comprise: a first conduit coupler; a second conduit coupler; and a third conduit coupler. In some embodiments, the first conduit coupler may comprise a first negative-pressure pathway and a first pressure-sensing pathway; the second conduit coupler may comprise a second negative-pressure pathway; the third (e.g. output) conduit coupler may comprise a third (e.g. an output) negative-pressure pathway and a third (e.g. output) pressure-sensing pathway; and the first negative-pressure pathway and second negative-pressure pathway may both fluidly couple to the output negative-pressure pathway. In some embodiments, the first pressure-sensing pathway may fluidly couple to the output pressure-sensing pathway. In some embodiments, the second conduit coupler may further comprise a second pressure-sensing pathway, and the first pressure-sensing pathway and the second pressure-sensing pathway may both fluidly couple to the output pressure-sensing pathway. In some embodiments, the first, second, and output negative-pressure pathways may be fluidly isolated from the first, second, and output pressure-sensing pathways. In some embodiments, the first conduit coupler may comprise at least one valve configured to open when the first conduit coupler experiences negative-pressure and to close in the absence of negative-pressure; and the second conduit coupler may comprises at least one valve configured to open when the second conduit coupler experiences negative-pressure and to close in the absence of negative-pressure. In some embodiments, the first, second, and third (e.g. output) conduit couplers may each comprise a removable attachment device for removably coupling the respective conduits to the corresponding conduit coupler.

<FIG> is a block diagram of an example embodiment of a therapy system <NUM> that can provide negative-pressure therapy with instillation of topical treatment solutions to a tissue site in accordance with this specification.

The term "tissue site" in this context broadly refers to a wound, defect, or other treatment target located on or within tissue, including, but not limited to, bone tissue, adipose tissue, muscle tissue, neural tissue, dermal tissue, vascular tissue, connective tissue, cartilage, tendons, or ligaments. A wound may include chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness bums, ulcers (such as diabetic, pressure, or venous insufficiency ulcers), flaps, and grafts, for example. The term "tissue site" may also refer to areas of any tissue that are not necessarily wounded or defective, but are instead areas in which it may be desirable to add or promote the growth of additional tissue. For example, negative pressure may be applied to a tissue site to grow additional tissue that may be harvested and transplanted.

The therapy system <NUM> may include a source or supply of negative pressure, such as a negative-pressure source <NUM>, and one or more distribution components. A distribution component is preferably detachable and may be disposable, reusable, or recyclable. A dressing, such as a dressing <NUM>, and a fluid container, such as an exudate container <NUM>, are examples of distribution components that may be associated with some examples of the therapy system <NUM>. As illustrated in the example of <FIG>, the dressing <NUM> may comprise or consist essentially of a tissue interface <NUM>, a cover <NUM>, or both in some embodiments.

The therapy system <NUM> may also include a source of instillation solution. For example, a solution source <NUM> may be fluidly coupled to the dressing <NUM>, as illustrated in the example embodiment of <FIG>. The solution source <NUM> may be fluidly coupled to a positive-pressure source, such as a positive-pressure source <NUM>, a negative-pressure source such as the negative-pressure source <NUM>, or both in some embodiments. A regulator, such as an instillation regulator <NUM>, may also be fluidly coupled to the solution source <NUM> and the dressing <NUM> to ensure proper dosage of instillation solution (e.g. saline) to a tissue site. For example, the instillation regulator <NUM> may comprise a piston that can be pneumatically actuated by the negative-pressure source <NUM> to draw instillation solution from the solution source during a negative-pressure interval and to instill the solution to a dressing during a venting interval. Additionally or alternatively, the controller <NUM> may be coupled to the negative-pressure source <NUM>, the positive-pressure source <NUM>, or both, to control dosage of instillation solution to a tissue site. In some embodiments, the instillation regulator <NUM> may also be fluidly coupled to the negative-pressure source <NUM> through the dressing <NUM>, as illustrated in the example of <FIG>.

Some embodiments of the therapy system <NUM> may include an instillation sensor module <NUM>, configured to receive instillation fluid and sense it prior to delivery to the dressing <NUM>. In some embodiments, the instillation sensor module <NUM> may be in fluid communication with the solution source <NUM> and the dressing <NUM>. For example, the instillation sensor module <NUM> may be configured so that it may detect any instillation fluid prior to delivery of instillation fluid to the dressing <NUM>. In some embodiments, the instillation sensor module <NUM> may be configured to sense the composition and/or concentration of the instillation fluid from the solution source <NUM>, for example allowing confirmation of the fluid type prior to application to the tissue site.

Some components of the therapy system <NUM> may be housed within or used in conjunction with other components, such as sensors, processing units, alarm indicators, memory, databases, software, display devices, or user interfaces that further facilitate therapy. For example, in some embodiments, the negative-pressure source <NUM> may be combined with the controller <NUM>, the solution source <NUM>, and/or other components (such as sensors) into a therapy unit <NUM>.

A negative-pressure supply, such as the negative-pressure source <NUM>, may be a reservoir of air at a negative pressure or may be a manual or electrically-powered device, such as a vacuum pump, a suction pump, a wall suction port available at many healthcare facilities, or a micro-pump, for example. "Negative pressure" generally refers to a pressure less than a local ambient pressure, such as the ambient pressure in a local environment external to a sealed therapeutic environment. In many cases, the local ambient pressure may also be the atmospheric pressure at which a tissue site is located. Alternatively, the pressure may be less than a hydrostatic pressure associated with tissue at the tissue site. Unless otherwise indicated, values of pressure stated herein are gauge pressures. References to increases in negative pressure typically refer to a decrease in absolute pressure, while decreases in negative pressure typically refer to an increase in absolute pressure. While the amount and nature of negative pressure provided by the negative-pressure source <NUM> may vary according to therapeutic requirements, the pressure is generally a low vacuum, also commonly referred to as a rough vacuum, between -<NUM> Hg (-<NUM> Pa) and -<NUM> Hg (-<NUM> kPa). Common therapeutic ranges are between -<NUM> Hg (-<NUM> kPa) and -<NUM> Hg (-<NUM> kPa).

In some embodiments, the tissue interface <NUM> may include or may be a manifold. A manifold in this context may comprise or consist essentially of a means for collecting or distributing fluid relative to a tissue site under pressure. For example, a manifold may be adapted to receive negative pressure from a source and distribute negative pressure through multiple apertures across the tissue interface <NUM>, which may have the effect of collecting fluid from across a tissue site and drawing the fluid toward the source. In some embodiments, the fluid path may be reversed or a secondary fluid path may be provided to facilitate delivering fluid, such as fluid from a source of instillation solution, across a tissue site.

In some illustrative embodiments, a manifold may comprise a plurality of pathways, which can be interconnected to improve distribution or collection of fluids. In some illustrative embodiments, a manifold may comprise or consist essentially of a porous material having interconnected fluid pathways. Examples of suitable porous material that can be adapted to form interconnected fluid pathways (e.g., channels) may include cellular foam, including open-cell foam such as reticulated foam; porous tissue collections; and other porous material such as gauze or felted mat that generally include pores, edges, and/or walls. Liquids, gels, and other foams may also include or be cured to include apertures and fluid pathways. In some embodiments, a manifold may additionally or alternatively comprise projections that form interconnected fluid pathways. For example, a manifold may be molded to provide surface projections that define interconnected fluid pathways.

In some embodiments, the tissue interface <NUM> may comprise or consist essentially of reticulated foam having pore sizes and free volume that may vary according to needs of a prescribed therapy. For example, reticulated foam having a free volume of at least <NUM>% may be suitable for many therapy applications, and foam having an average pore size in a range of <NUM>-<NUM> microns (<NUM>-<NUM> pores per inch) may be particularly suitable for some types of therapy. The tensile strength of the tissue interface <NUM> may also vary according to needs of a prescribed therapy. For example, the tensile strength of foam may be increased for instillation of topical treatment solutions. The <NUM>% compression load deflection of the tissue interface <NUM> may be at least <NUM> pounds per square inch, and the <NUM>% compression load deflection may be at least <NUM> pounds per square inch. In some embodiments, the tensile strength of the tissue interface <NUM> may be at least <NUM> pounds per square inch. The tissue interface <NUM> may have a tear strength of at least <NUM> pounds per inch. In some embodiments, the tissue interface may be foam comprised of polyols such as polyester or polyether, isocyanate such as toluene diisocyanate, and polymerization modifiers such as amines and tin compounds. In some examples, the tissue interface <NUM> may be reticulated polyurethane foam such as found in GRANUFOAM™ dressing or V. VERAFLO™ dressing, both available from Kinetic Concepts, Inc.

The thickness of the tissue interface <NUM> may also vary according to needs of a prescribed therapy. For example, the thickness of the tissue interface may be decreased to reduce tension on peripheral tissue. The thickness of the tissue interface <NUM> can also affect the conformability of the tissue interface <NUM>. In some embodiments, a thickness in a range of about <NUM> millimeters to <NUM> millimeters may be suitable.

The tissue interface <NUM> may be either hydrophobic or hydrophilic. In an example in which the tissue interface <NUM> may be hydrophilic, the tissue interface <NUM> may also wick fluid away from a tissue site, while continuing to distribute negative pressure to the tissue site. The wicking properties of the tissue interface <NUM> may draw fluid away from a tissue site by capillary flow or other wicking mechanisms. An example of a hydrophilic material that may be suitable is a polyvinyl alcohol, open-cell foam such as V. WHITEFOAM™ dressing available from Kinetic Concepts, Inc. Other hydrophilic foams may include those made from polyether. Other foams that may exhibit hydrophilic characteristics include hydrophobic foams that have been treated or coated to provide hydrophilicity.

In some embodiments, the tissue interface <NUM> may be constructed from bioresorbable materials. Suitable bioresorbable materials may include, without limitation, a polymeric blend of polylactic acid (PLA) and polyglycolic acid (PGA). The polymeric blend may also include, without limitation, polycarbonates, polyfumarates, and caprolactones. The tissue interface <NUM> may further serve as a scaffold for new cell-growth, or a scaffold material may be used in conjunction with the tissue interface <NUM> to promote cell-growth. A scaffold is generally a substance or structure used to enhance or promote the growth of cells or formation of tissue, such as a three-dimensional porous structure that provides a template for cell growth. Illustrative examples of scaffold materials include calcium phosphate, collagen, PLA/PGA, coral hydroxy apatites, carbonates, or processed allograft materials.

In some embodiments, the cover <NUM> may provide a bacterial barrier and protection from physical trauma. The cover <NUM> may also be constructed from a material that can reduce evaporative losses and provide a fluid seal between two components or two environments, such as between a therapeutic environment and a local external environment. The cover <NUM> may comprise or consist of, for example, an elastomeric film or membrane that can provide a seal adequate to maintain a negative pressure at a tissue site for a given negative-pressure source. The cover <NUM> may have a high moisture-vapor transmission rate (MVTR) in some applications. For example, the MVTR may be at least <NUM> grams per square meter per twenty-four hours in some embodiments, measured using an upright cup technique according to ASTM E96/E96M Upright Cup Method at <NUM> and <NUM>% relative humidity (RH). In some embodiments, an MVTR up to <NUM>,<NUM> grams per square meter per twenty-four hours may provide effective breathability and mechanical properties.

In some example embodiments, the cover <NUM> may be a polymer drape, such as a polyurethane film, that is permeable to water vapor but impermeable to liquid. Such drapes typically have a thickness in the range of <NUM>-<NUM> microns. For permeable materials, the permeability generally should be low enough that a desired negative pressure may be maintained. The cover <NUM> may comprise, for example, one or more of the following materials: polyurethane (PU), such as hydrophilic polyurethane; cellulosics; hydrophilic polyamides; polyvinyl alcohol; polyvinyl pyrrolidone; hydrophilic acrylics; silicones, such as hydrophilic silicone elastomers; natural rubbers; polyisoprene; styrene butadiene rubber; chloroprene rubber; polybutadiene; nitrile rubber; butyl rubber; ethylene propylene rubber; ethylene propylene diene monomer; chlorosulfonated polyethylene; polysulfide rubber; ethylene vinyl acetate (EVA); co-polyester; and polyether block polymide copolymers. Such materials are commercially available as, for example, Tegaderm® drape, commercially available from <NUM> Company, Minneapolis Minnesota; polyurethane (PU) drape, commercially available from Avery Dennison Corporation, Pasadena, California; polyether block polyamide copolymer (PEBAX), for example, from Arkema S. , Colombes, France; and Inspire <NUM> and Inpsire <NUM> polyurethane films, commercially available from Transcontinental Advanced Coating, Wrexham, United Kingdom. In some embodiments, the cover <NUM> may comprise INSPIRE <NUM> having an MVTR (upright cup technique) of <NUM>/m<NUM>/<NUM> hours and a thickness of about <NUM> microns.

An attachment device may be used to attach the cover <NUM> to an attachment surface, such as undamaged epidermis, a gasket, or another cover. The attachment device may take many forms. For example, an attachment device may be a medically-acceptable, pressure-sensitive adhesive configured to bond the cover <NUM> to epidermis around a tissue site. In some embodiments, for example, some or all of the cover <NUM> may be coated with an adhesive, such as an acrylic adhesive, which may have a coating weight of about <NUM>-<NUM> grams per square meter (g. Thicker adhesives, or combinations of adhesives, may be applied in some embodiments to improve the seal and reduce leaks. Other example embodiments of an attachment device may include a double-sided tape, paste, hydrocolloid, hydrogel, silicone gel, or organogel.

The solution source <NUM> may also be representative of a container, canister, pouch, bag, bottle, or other storage component, which can provide a solution for instillation therapy. Compositions of solutions may vary according to a prescribed therapy, but examples of solutions that may be suitable for some prescriptions include saline solution, hypochlorite-based solutions, silver nitrate (<NUM>%), sulfur-based solutions, biguanides, cationic solutions, isotonic solutions, PRONTOSAN® Wound Irrigation Solution from B. Braun Medical, Inc. , and combinations thereof. In one illustrative embodiment, the solution source <NUM> may include a storage component for the solution and a separate cassette or cartridge for holding the storage component and delivering the solution to the tissue site <NUM>, such as a V. VeraLink™ Cassette available from Kinetic Concepts, Inc.

The process of reducing pressure may be described illustratively herein as "delivering," "distributing," or "generating" negative pressure, for example. In general, exudate and other fluid flow toward lower pressure along a fluid path. Thus, the term "downstream" typically refers to a location in a fluid path relatively closer to a source of negative pressure or further away from a source of positive pressure. Conversely, the term "upstream" refers to a location in a fluid path relatively further away from a source of negative pressure or closer to a source of positive pressure. Similarly, it may be convenient to describe certain features in terms of fluid "inlet" or "outlet" in such a frame of reference. This orientation is generally presumed for purposes of describing various features and components herein. However, the fluid path may also be reversed in some applications, such as by substituting a positive-pressure source for a negative-pressure source, and such a description should not be construed as limiting.

Negative pressure applied across the tissue site through the tissue interface <NUM> in the sealed therapeutic environment can induce macro-strain and micro-strain in the tissue site. Negative pressure can also remove exudate and other fluid from a tissue site, which can be collected in container <NUM>.

In some embodiments, the controller <NUM> may receive and process data from one or more sensors, such as the first sensor <NUM>. The controller <NUM> may also control the operation of one or more components of the therapy system <NUM> to manage the pressure delivered to the tissue interface <NUM>. In some embodiments, controller <NUM> may include an input for receiving a desired target pressure and may be programmed for processing data relating to the setting and inputting of the target pressure to be applied to the tissue interface <NUM>. In some example embodiments, the target pressure may be a fixed pressure value set by an operator as the target negative pressure desired for therapy at a tissue site and then provided as input to the controller <NUM>. The target pressure may vary from tissue site to tissue site based on the type of tissue forming a tissue site, the type of injury or wound (if any), the medical condition of the patient, and the preference of the attending physician. After selecting a desired target pressure, the controller <NUM> can operate the negative-pressure source <NUM> in one or more control modes based on the target pressure and may receive feedback from one or more sensors to maintain the target pressure at the tissue interface <NUM>.

<FIG> is a graph illustrating additional details of an example control mode that may be associated with some embodiments of the controller <NUM>. In some embodiments, the controller <NUM> may have a continuous pressure mode, in which the negative-pressure source <NUM> is operated to provide a constant target negative pressure, as indicated by line <NUM> and line <NUM>, for the duration of treatment or until manually deactivated. Additionally or alternatively, the controller may have an intermittent pressure mode, as illustrated in the example of <FIG>. In <FIG>, the x-axis represents time and the y-axis represents negative pressure generated by the negative-pressure source <NUM> over time. In the example of <FIG>, the controller <NUM> can operate the negative-pressure source <NUM> to cycle between a target pressure and atmospheric pressure. For example, the target pressure may be set at a value of <NUM> mmHg, as indicated by line <NUM>, for a specified period of time (e.g., <NUM>), followed by a specified period of time (e.g., <NUM>) of deactivation, as indicated by the gap between the solid lines <NUM> and <NUM>. The cycle can be repeated by activating the negative-pressure source <NUM>, as indicated by line <NUM>, which can form a square wave pattern between the target pressure and atmospheric pressure.

In some example embodiments, the increase in negative-pressure from ambient pressure to the target pressure may not be instantaneous. For example, the negative-pressure source <NUM> and the dressing <NUM> may have an initial rise time, as indicated by the dashed line <NUM>. The initial rise time may vary depending on the type of dressing and therapy equipment being used. For example, the initial rise time for one therapy system may be in a range of about <NUM>-<NUM> mmHg/second and in a range of about <NUM>-<NUM> mmHg/second for another therapy system. If the therapy system <NUM> is operating in an intermittent mode, the repeating rise time, as indicated by the solid line <NUM>, may be a value substantially equal to the initial rise time as indicated by the dashed line <NUM>.

<FIG> is a graph illustrating additional details that may be associated with another example pressure control mode in some embodiments of the therapy system <NUM>. In <FIG>, the x-axis represents time and the y-axis represents negative pressure generated by the negative-pressure source <NUM>. The target pressure in the example of <FIG> can vary with time in a dynamic pressure mode. For example, the target pressure may vary in the form of a triangular waveform, varying between a negative pressure of <NUM> and <NUM> mmHg with a rise time <NUM> set at a rate of +<NUM> mmHg/min. and a descent time <NUM> set at -<NUM> mmHg/min. In other embodiments of the therapy system <NUM>, the triangular waveform may vary between negative pressure of <NUM> and <NUM> mmHg with a rise time <NUM> set at a rate of +<NUM> mmHg/min and a descent time <NUM> set at -<NUM> mmHg/min.

In some embodiments, the controller <NUM> may control or determine a variable target pressure in a dynamic pressure mode, and the variable target pressure may vary between a maximum and minimum pressure value that may be set as an input prescribed by an operator as the range of desired negative pressure. The variable target pressure may also be processed and controlled by the controller <NUM>, which can vary the target pressure according to a predetermined waveform, such as a triangular waveform, a sine waveform, or a saw-tooth waveform. In some embodiments, the waveform may be set by an operator as the predetermined or time-varying negative pressure desired for therapy.

<FIG> is a chart illustrating details that may be associated with an example method <NUM> of operating the therapy system <NUM> to provide negative-pressure treatment and instillation treatment to the tissue interface <NUM>. In some embodiments, the controller <NUM> may receive and process data, such as data related to instillation solution provided to the tissue interface <NUM>. Such data may include the type of instillation solution prescribed by a clinician, the volume of fluid or solution to be instilled to a tissue site ("fill volume"), and the amount of time prescribed for leaving solution at a tissue site ("dwell time") before applying a negative pressure to the tissue site. The fill volume may be, for example, between <NUM> and <NUM>, and the dwell time may be between one second to <NUM> minutes. The controller <NUM> may also control the operation of one or more components of the therapy system <NUM> to instill solution, as indicated at <NUM>. For example, the controller <NUM> may manage fluid distributed from the solution source <NUM> to the tissue interface <NUM>. In some embodiments, fluid may be instilled to a tissue site by applying a negative pressure from the negative-pressure source <NUM> to reduce the pressure at the tissue site, drawing solution into the tissue interface <NUM>, as indicated at <NUM>. In some embodiments, solution may be instilled to a tissue site by applying a positive pressure from the positive-pressure source <NUM> to move solution from the solution source <NUM> to the tissue interface <NUM>, as indicated at <NUM>. Additionally or alternatively, the solution source <NUM> may be elevated to a height sufficient to allow gravity to move solution into the tissue interface <NUM>, as indicated at <NUM>.

The controller <NUM> may also control the fluid dynamics of instillation at <NUM> by providing a continuous flow of solution at <NUM> or an intermittent flow of solution at <NUM>. Negative pressure may be applied to provide either continuous flow or intermittent flow of solution at <NUM>. The application of negative pressure may be implemented to provide a continuous pressure mode of operation at <NUM> to achieve a continuous flow rate of instillation solution through the tissue interface <NUM>, or it may be implemented to provide a dynamic pressure mode of operation at <NUM> to vary the flow rate of instillation solution through the tissue interface <NUM>. Alternatively, the application of negative pressure may be implemented to provide an intermittent mode of operation at <NUM> to allow instillation solution to dwell at the tissue interface <NUM>. In an intermittent mode, a specific fill volume and dwell time may be provided depending, for example, on the type of tissue site being treated and the type of dressing being utilized. After or during instillation of solution, negative-pressure treatment may be applied at <NUM>. The controller <NUM> may be utilized to select a mode of operation and the duration of the negative pressure treatment before commencing another instillation cycle at <NUM> by instilling more solution at <NUM>.

<FIG> is a schematic view of an embodiment of a negative-pressure therapy system <NUM>, illustrating additional details that may be associated with some embodiments of the therapy system <NUM> of <FIG>. In <FIG>, the negative-pressure and pressure-sensing from the therapy unit <NUM> may be distributed between more than one exudate container <NUM>, such as between two or more canisters (configured to collect exudate), and thereby to one or more tissue sites <NUM>. <FIG> illustrates two canisters, for example a first canister <NUM> and a second canister <NUM>, fluidly coupled to the therapy unit <NUM> by a multi-canister module <NUM>.

In some embodiments, the multi-canister module <NUM> may comprise: an input negative-pressure port <NUM> configured to be fluidly coupled to and to receive negative pressure from the negative-pressure source <NUM>, shown in <FIG>, for example; a therapy pressure-sensing port <NUM> configured to be fluidly coupled to a pressure sensor, which may be external, such as, for example, the first sensor <NUM> shown with the therapy unit <NUM> in <FIG>; a first receptor, which may be or may include a first releasable latch mechanism <NUM> configured for removable attachment of the first canister <NUM>; a second receptor, which may be or may include a second releasable latch mechanism <NUM> configured for removable attachment of the second canister <NUM>; a first negative-pressure port <NUM> fluidly coupled to the input negative-pressure port <NUM>; a first pressure-sensing port <NUM> fluidly coupled to the therapy pressure-sensing port <NUM>; a second negative-pressure port <NUM> fluidly coupled to the input negative-pressure port <NUM>; and a second pressure-sensing port <NUM>. In some embodiments, the first negative-pressure port <NUM> may also be configured for fluid coupling to the first canister <NUM>, such that the first negative-pressure port <NUM> may be configured to fluidly couple the first canister <NUM> to the input negative-pressure port <NUM> while the first canister <NUM> is attached to the multi-canister module <NUM>, for example, by the first releasable latch mechanism <NUM>. Similarly, the second negative-pressure port <NUM> may be configured for fluid coupling to the second canister <NUM>, such that the second negative-pressure port <NUM> may be configured to fluidly couple the second canister <NUM> to the input negative-pressure port <NUM> while the second canister <NUM> is attached to the multi-canister module <NUM>, for example, by the second releasable latch mechanism <NUM>. In some embodiments, the first pressure-sensing port <NUM> may be configured for fluid coupling to the first canister <NUM>, such that the first pressure-sensing port <NUM> may be configured to fluidly couple the first canister <NUM> to the therapy pressure-sensing port <NUM> while the first canister <NUM> is attached to the multi-canister module <NUM>, for example, by the first releasable latch mechanism <NUM>. Similarly, the second pressure-sensing port <NUM> may be configured for fluid coupling to the second canister <NUM> while the second canister <NUM> is attached to the multi-canister module <NUM>, for example, by the second releasable latch mechanism <NUM>. In some embodiments, a fluid flowpath from the input negative-pressure port <NUM> may divide and fluidly couple to both the first negative-pressure port <NUM> and the second negative-pressure port <NUM>, as shown in more detail in <FIG>. In some embodiments, the negative-pressure ports may be fluidly isolated from the pressure-sensing ports. For example, the first negative-pressure port <NUM> and the second negative-pressure port <NUM> may be fluidly isolated from the first pressure-sensing port <NUM> and the second pressure-sensing port <NUM>. In some embodiments, the first releasable latch mechanism <NUM> may be substantially similar to the second releasable latch mechanism <NUM>.

Some embodiments of the multi-canister module <NUM> may further comprise a housing <NUM>. For example, the first negative-pressure port <NUM>, the second negative-pressure port <NUM>, the first pressure-sensing port <NUM>, the second pressure-sensing port <NUM>, the first releasable latch mechanism <NUM>, the second releasable latch mechanism <NUM>, the input negative-pressure port <NUM>, and the therapy pressure-sensing port <NUM> may all be mounted on the housing <NUM>. In some embodiments, fluid communication between specific ports may be provided by, for example and without limitation, linking conduits, tubes, or passages that may be positioned inside, within, or integral to the housing <NUM>, or carried by or otherwise associated with the housing <NUM>, for providing the necessary fluid flowpaths. In some embodiments, the first negative-pressure port <NUM> may be located in proximity to the first pressure-sensing port <NUM>, so that a first two-pathway conduit <NUM> may couple to both the first negative-pressure port <NUM> and the first pressure-sensing port <NUM> (e.g. through the first canister <NUM>). In some embodiments, the second negative-pressure port <NUM> may be located in proximity to the second pressure-sensing port <NUM>, so that a second two-pathway conduit <NUM> may couple to both the second negative-pressure port <NUM> and the second pressure-sensing port <NUM>. In some embodiments, the first negative-pressure port <NUM>, the first pressure-sensing port <NUM>, and the first releasable latch mechanism <NUM> may be located on one side of the housing <NUM>, while the second negative-pressure port <NUM>, the second pressure-sensing port <NUM>, and the second releasable latch mechanism <NUM> may be located on another side of the housing <NUM>, such as an opposite side of the housing <NUM>. In some embodiments, one or both of the releasable latch mechanisms may comprise or be associated with a release mechanism <NUM>, such as a button configured to allow detachment of the corresponding canister. For example, there may be separate release mechanisms <NUM> corresponding to each canister in some embodiments.

In some embodiments, the housing <NUM> may comprise a base <NUM>, which may be configured to stand on a horizontal surface. In some embodiments, the base <NUM> may be configured so that, when the base <NUM> is located on the horizontal surface, the first canister <NUM> and the second canister <NUM> are oriented upright when attached to the multi-canister module <NUM>. In some embodiments, the housing <NUM> may comprise a hanging element <NUM>, which may be configured to allow the multi-canister module <NUM> to hang from an IV stand or other support device configured to retain hanging objects. In some embodiments, the hanging element <NUM> may be configured so that, when the device is hanging by the hanging element <NUM>, the first canister <NUM> and the second canister <NUM> are oriented upright when attached to the multi-canister module <NUM>.

In some embodiments of the system, the first canister <NUM> may be configured to releasably attach to the multi-canister module <NUM> via the first releasable latch mechanism <NUM> and to fluidly couple to the first negative-pressure port <NUM> and the first pressure-sensing port <NUM>. In some embodiments, the second canister <NUM> may be configured to releasably attach to the multi-canister module <NUM> via the second releasable latch mechanism <NUM> and to fluidly couple to the second negative-pressure port <NUM> and the second pressure-sensing port <NUM>. For example, the first canister <NUM> may comprise a first pathway <NUM> configured for negative pressure transmission and a second pathway <NUM> configured for pressure-sensing; and the second canister <NUM> may comprise a third pathway <NUM> configured for negative pressure transmission and a fourth pathway <NUM> configured for pressure-sensing. In some embodiments, the second pathway <NUM> may directly fluidly couple the first pressure-sensing port <NUM> to the pressure-sensing pathway of a two-pathway conduit (e.g. the second pathway <NUM> may form the pressure-sensing pathway of a two-pathway conduit), while the first pathway <NUM> may fluidly couple the first negative-pressure port <NUM> to a storage space <NUM> of the canister, and thereby to the negative-pressure pathway of the two-pathway conduit.

In some embodiments, the first canister <NUM> may comprise or fluidly couple to a first two-pathway conduit <NUM>. In some embodiments, the first two-pathway conduit <NUM> may comprise a negative-pressure pathway and a pressure-sensing pathway. For example, the first two-pathway conduit <NUM> may comprise the first pathway <NUM> fluidly coupled to the first negative-pressure port <NUM> and the second pathway <NUM> fluidly coupled to the first pressure-sensing port <NUM>. In some embodiments, the first pathway <NUM> may be in fluid communication with the first negative -pressure port <NUM> through the fluid storage space <NUM> of the first canister <NUM>, and the second pathway <NUM> may be directly coupled to the first pressure-sensing port <NUM>. In some embodiments, there may be no fluid communication between the first negative-pressure port <NUM> and the second pathway <NUM> or the first pressure-sensing port <NUM> and the first pathway <NUM>. In some embodiments, the first two-pathway conduit <NUM> may be located in proximity to the top of the first canister <NUM>.

In some embodiments, the second canister <NUM> may be configured similarly to the first canister <NUM>. For example, the second canister <NUM> may comprise or fluidly couple to a second two-pathway conduit <NUM>. In some embodiments, the second two-pathway conduit <NUM> may comprise a negative-pressure pathway and a pressure-sensing pathway. For example, the second two-pathway conduit <NUM> may comprise the third pathway <NUM> fluidly coupled to the second negative-pressure port <NUM> and the fourth pathway <NUM> fluidly coupled to the second pressure-sensing port <NUM>. In some embodiments, the second two-pathway conduit <NUM> may be located in proximity to the top of the second canister <NUM>. In some embodiments, the third pathway <NUM> may be in fluid communication with the second negative-pressure port <NUM> through a fluid storage space <NUM> of the second canister <NUM>, and the fourth pathway <NUM> may be directly coupled to the second pressure-sensing port <NUM>. In some embodiments, there may be no fluid communication between the second negative-pressure port <NUM> and the fourth pathway <NUM> or the second pressure-sensing port <NUM> and the third pathway <NUM>.

Some embodiments may further comprise a therapy unit adapter <NUM> configured to fluidly couple the input negative-pressure port <NUM> and the therapy pressure-sensing port <NUM> to the therapy unit <NUM>. In some embodiments, the therapy unit <NUM> may comprise the negative-pressure source <NUM>, the pressure sensor <NUM>, and the controller <NUM> configured to operate the negative-pressure source <NUM> based at least partially on sensed pressure from the pressure sensor (e.g. the first sensor <NUM>). In some embodiments, the therapy unit <NUM> may be configured for attachment of only a single canister. For example, the therapy unit <NUM> may further comprise only a single negative-pressure output port <NUM> (e.g. fluidly coupled to the negative-pressure source <NUM>), only a single pressure-sensing input port <NUM> (e.g. fluidly coupled to the pressure sensor), and a unit releasable latch mechanism <NUM> which may be configured to allow a single canister to be attached to the therapy unit <NUM>. In some embodiments, the therapy unit adapter <NUM> may be configured to removably attach to the therapy unit <NUM>. For example, the therapy unit adapter <NUM> may be configured to attach to the therapy unit <NUM> via the unit releasable latch mechanism <NUM> of the therapy unit <NUM>. In some embodiments, each of the first releasable latch mechanism <NUM> and second releasable latch mechanism <NUM> may be substantially identical to the unit releasable latch mechanism <NUM>. In some embodiments, the therapy unit adapter <NUM> may be configured to fluidly couple the input negative-pressure port <NUM> of the multi-canister module <NUM> to the negative-pressure output port <NUM> of the therapy unit <NUM>, and to couple the therapy pressure-sensing port <NUM> of the multi-canister module <NUM> to the pressure-sensing input port <NUM> of the therapy unit <NUM>. Some embodiments may further comprise a filter <NUM> configured to prevent ingress of fluid into the therapy unit <NUM>. In some embodiments, the filter <NUM> may be hydrophobic and/or antimicrobial. In some embodiments, the therapy unit adapter <NUM> may comprise a plate <NUM>, which may be configured to fit flush with the therapy unit <NUM> upon attachment of the therapy unit adapter <NUM> to the therapy unit <NUM>. In some embodiments, the plate <NUM> may be configured to seat within a lip <NUM> of the therapy unit <NUM>.

Some embodiments may further comprise a first dressing 110a and a second dressing 110b, wherein the first two-pathway conduit <NUM> may fluidly couple the first dressing 110a to the first canister <NUM>, and the second two-pathway conduit <NUM> may fluidly couple the second dressing 110b to the second canister <NUM>. Some embodiments may further comprise a blood detection alarm (not shown), which may be configured to detect blood in one or both of the canisters. For example, the blood detection alarm may be configured to have optical sensors looking through one or both canister continuously to detect a flow of fresh blood into the canisters. Responsive to the sensors detecting blood, an alarm may be triggered. In some embodiments, responsive to the detection of blood, a signal may be transmitted to the therapy unit <NUM>, deactivating the negative-pressure source <NUM>. In some embodiments, the blood detection alarm may be battery-powered.

Some embodiments may further comprise a canister full notification element (not shown), which may be configured to detect when one or both canisters are full and to provide an indication. For example, sensors may be configured to detect when one or both canisters are becoming full (e.g. approximately <NUM>% or <NUM>% of total capacity), and to trigger an alarm responsive to such detection. The alarm may be integral to the canister full notification element, or a signal may be transmitted to the therapy unit <NUM>, which may issue notification or alarm. In some embodiments, the canisters may be substantially transparent or translucent, and the notification or alarm may be indicated by illuminating the canister at issue. For example, a light element, such as an LED, may be located within the canister and may be configured to illuminate responsive to detection of the canister becoming full. An ultra-bright LED in close proximity to the wall of the canister may be configured to use the canister as a light pipe, for example. In some embodiments, the canister full notification element may be battery-powered.

Some embodiments may further comprise filters at the ports, which may prevent ingress of liquid from the canisters to the multi-canister module <NUM>. For example, the first negative-pressure port <NUM> and the second negative-pressure port <NUM> may each have a port filter, or there may be port filters corresponding to the location of these ports within the canisters. In some embodiments, the first pressure-sensing port <NUM> and the second pressure-sensing port <NUM> may also have port filters, or there may be port filters corresponding to the location of these ports within the canisters. The port filters may each be configured to prevent ingress of fluid liquid from the canisters into the multi-canister module <NUM> (e.g. preventing liquid from leaving the canisters and entering the multi-canister module housing <NUM>). For example, the port filters may be hydrophobic and/or antimicrobial.

<FIG> is a partial interior schematic view of an embodiment of an example multi-canister module <NUM> of <FIG>, illustrating additional details that may be associated with some embodiments. In some embodiments, the second releasable latch mechanism <NUM> may be configured so that when the second canister <NUM> is attached, the second negative-pressure port <NUM> and the second pressure-sensing port <NUM> are open; but when the second canister <NUM> is not attached, the second negative-pressure port <NUM> and the second pressure-sensing port <NUM> are closed. For example, the second releasable latch mechanism <NUM> may be configured to open the second negative-pressure port <NUM> and the second pressure-sensing port <NUM> upon attachment of the second canister <NUM>, and to close the second negative-pressure port <NUM> and the second pressure-sensing port <NUM> upon detachment of the second canister <NUM>. In some embodiments, the first releasable latch mechanism <NUM> may be configured so that when the first canister <NUM> is attached, the first negative-pressure port <NUM> and the first pressure-sensing port <NUM> are open; but when the first canister <NUM> is not attached, the first negative-pressure port <NUM> and the first pressure-sensing port <NUM> are closed. For example, the first releasable latch mechanism <NUM> may be configured to open the first negative-pressure port <NUM> and the first pressure-sensing port <NUM> upon attachment of the first canister <NUM>, and to close the first negative-pressure port <NUM> and the first pressure-sensing port <NUM> upon detachment of the first canister <NUM>.

In some embodiments, the first negative-pressure port <NUM> and the first pressure-sensing port <NUM> may each comprise a sealing valve <NUM> that is biased closed (e.g. by a spring <NUM>) but configured to open by attachment of the first canister <NUM>; and the second pressure-sensing port <NUM> and the second negative-pressure port <NUM> may each comprise a sealing valve <NUM> that is biased closed (e.g. by a spring <NUM>) but configured to open by attachment of the second canister <NUM>. For example, these sealing valves <NUM> may comprise one or more pistons <NUM> configured to press on and collapse the conduits associated with the corresponding ports. The pistons <NUM> may be coupled to an actuator <NUM> in the corresponding releasable latch mechanism, which may be configured to open and close the ports in response to attachment of the corresponding canister. <FIG> illustrates the valves in closed configuration, when the corresponding canister is not attached.

In some embodiments, the first negative-pressure port <NUM> and the second negative-pressure port <NUM> may be fluidly isolated from the first pressure-sensing port <NUM> and the second negative-pressure port <NUM>. In some embodiments, a fluid flowpath from the input negative-pressure port <NUM> may divide and fluidly couple to both the first negative-pressure port <NUM> and the second negative-pressure port <NUM>. In some embodiments, the fluid flowpath from the therapy pressure-sensing port <NUM> may divide and fluidly couple to both the first pressure-sensing port <NUM> and the second pressure-sensing port. In some embodiments, the fluid flowpaths may comprise conduits, such as tubing.

<FIG> is a partial schematic view related to <FIG> (e.g. with <FIG> illustrating the closed configuration when the canister is not attached, and <FIG> illustrating an open configuration with the canister is attached), illustrating additional details that may be associated with some embodiments. In some embodiments, in the closed configuration, the corresponding ports may be sealed to prevent fluid flow therethrough. In <FIG>, the sealing valves <NUM> are shown in the open configuration (e.g. when the corresponding canister is attached). For example, attachment of the corresponding canister may drive the corresponding actuator <NUM>, and thereby move the corresponding pistons <NUM> away from the corresponding conduits (e.g. overcome the biasing to open the conduits). In some embodiments, when the sealing valves <NUM> are open, the first negative-pressure port <NUM> and the second negative-pressure port <NUM> may both fluidly couple to the input negative-pressure port <NUM>, such that negative-pressure from the input negative-pressure port <NUM> may be distributed to the first negative-pressure port <NUM> and the second negative-pressure port <NUM>. In some embodiments, the first negative-pressure port <NUM> and the second negative-pressure port <NUM> may each receive approximately the same negative pressure, which may be approximately equal to the negative pressure at the input negative-pressure port <NUM>. In some embodiments, when the sealing valves <NUM> are open, the first pressure-sensing port <NUM> and the second pressure-sensing port <NUM> may both fluidly couple to the therapy pressure-sensing port <NUM>, such that the therapy pressure-sensing port <NUM> receives an average pressure from the first pressure-sensing port <NUM> and the second pressure-sensing port <NUM>. When the controller <NUM> of the therapy unit <NUM> receives the average pressure from the therapy pressure-sensing port <NUM>, the controller <NUM> may adjust the negative pressure from the negative-pressure source <NUM> as appropriate for negative-pressure therapy.

<FIG> is a partial interior schematic view of another embodiment of an example multi-canister module <NUM> of <FIG>, illustrating additional details that may be associated with some embodiments. The embodiment shown in <FIG> may be similar to that of <FIG>, except that the second pressure sensing port <NUM> may not be fluidly coupled to the therapy pressure-sensing port <NUM>, but may instead be fluidly coupled to an internal pressure sensor <NUM>. The internal pressure sensor <NUM> may be configured to sense the pressure within the second pressure-sensing port <NUM> and to communicate the sensed pressure to the therapy unit <NUM> (e.g. to the controller <NUM>) via some means of communication. For example, the multi-canister module <NUM> of <FIG> may further comprise the internal pressure sensor <NUM> (e.g. within or carried by the multi-canister module <NUM>) and a wireless transmitter <NUM>. In some embodiments, the internal pressure sensor <NUM> may be fluidly coupled to the second pressure-sensing port <NUM> and may be configured to communicate sensed pressure to the wireless transmitter <NUM>. In some embodiments, the wireless transmitter <NUM> may be configured to communicate wirelessly with the therapy unit <NUM> (e.g. transmitting sensed pressure data from the internal pressure sensor <NUM> to the controller <NUM> of the therapy unit <NUM>). In some embodiments, the internal pressure sensor <NUM> may be configured to communicate with the therapy unit <NUM> (e.g. the controller <NUM>) by other communication means. For example, some embodiments may not comprise a wireless transmitter <NUM>, but may instead employ wired transmission of a signal indicative of the sensed pressure at the internal pressure sensor <NUM>.

The first pressure-sensing port <NUM> of <FIG> may be fluidly coupled to the therapy pressure-sensing port <NUM>, such that the external pressure sensor (e.g. the first sensor <NUM>) of the therapy unit <NUM> may sense the pressure at the first pressure-sensing port <NUM> and communicate that sensed pressure to the controller <NUM>. Also as in <FIG>, the first negative-pressure port <NUM> and the second negative-pressure port <NUM> may both be fluidly coupled to (e.g. merge with) the input negative-pressure port <NUM>. The sealing valve <NUM> system in <FIG> may also be similar to that in <FIG>, allowing the ports to be opened when the corresponding canister is attached and closed when the corresponding canister is detached.

When the controller <NUM> of the therapy unit <NUM> receives the sensed pressure data from the external pressure sensor and the sensed pressure data from the internal pressure sensor <NUM>, the controller <NUM> may then determine the appropriate negative pressure for negative-pressure therapy (e.g. based on pre-set protocols) and may control the negative-pressure source <NUM> appropriately. In some embodiments, the controller <NUM> may use the average of the sensed pressure from the internal pressure sensor <NUM> and the external pressure sensor. In some embodiments, the controller <NUM> may use the minimum sensed pressure from the internal pressure sensor <NUM> and the external pressure sensor (e.g. increasing the negative pressure sufficiently so that the minimum (e.g. lower) sensed pressure is sufficient for negative-pressure therapy.

<FIG> is a schematic view of another embodiment of a negative-pressure therapy system <NUM>, illustrating additional details that may be associated with some embodiments of the therapy system <NUM> of <FIG>. In some embodiments, the system of <FIG> may be similar to that of <FIG>, but with the second canister <NUM> being configured to only transmit negative pressure to the tissue site <NUM> (e.g. no second pressure-sensing port <NUM>). For example, the multi-canister module <NUM> may comprise the first negative-pressure port <NUM>, the second negative-pressure port <NUM>, and the first pressure-sensing port <NUM>, along with the first releasable latch mechanism <NUM> and the second releasable latch mechanism <NUM>. In some embodiments, the first negative-pressure port <NUM> and the second negative-pressure port <NUM> may be fluidly isolated from the first pressure-sensing port <NUM>. In some embodiments, the first negative-pressure port <NUM> and the second negative-pressure port <NUM> may be fluidly coupled to the input negative-pressure port <NUM>, while the first pressure-sensing port <NUM> may be fluidly coupled to the therapy pressure-sensing port <NUM>. The second canister <NUM> may be configured to only fluidly couple to the second negative-pressure port <NUM> (e.g. with no connection for a second pressure-sensing port <NUM>). In some embodiments, the second canister <NUM> may be fluidly coupled to and/or comprise a single-pathway conduit <NUM> (e.g. having only a negative-pressure pathway), which may also be fluidly coupled to the second negative-pressure port <NUM>. For example, the single pathway conduit may be fluidly coupled to the second negative-pressure port <NUM> through the storage space <NUM> of the second canister <NUM>.

<FIG> is a partial interior schematic view of an embodiment of an example multi-canister module <NUM> of <FIG>, illustrating additional details that may be associated with some embodiments. The embodiment of <FIG> may be similar to that of <FIG>, except that there is no second-pressure sensing port. In some embodiments, the second negative-pressure port <NUM> and the first negative-pressure port <NUM> may both fluidly couple to (e.g. merge at) the input negative-pressure port <NUM>, and the first pressure-sensing port <NUM> may fluidly couple to the therapy pressure-sensing port <NUM> (such that the therapy pressure sensing port receives only pressure from the first pressure-sensing port <NUM>). In some embodiments, the second negative-pressure port <NUM> may comprise a sealing valve <NUM> that is biased closed but configured to open by attachment of the second canister <NUM>. In some embodiments, the first negative-pressure port <NUM> and the first pressure sensing port may not have sealing valves (as shown in <FIG>). In other embodiments, the first negative-pressure port <NUM> and the first pressure-sensing port <NUM> may both comprise a sealing valve that is biased closed but configured to open by attachment of the first canister <NUM> (e.g. similar to <FIG>).

<FIG> is a schematic view of yet another embodiment of a negative-pressure therapy system <NUM>, illustrating additional details that may be associated with some embodiments of the therapy system <NUM> of <FIG>. The embodiment shown in <FIG> may be similar to that of <FIG>, but further including a branch adapter <NUM> fluidly coupling both the first and second canisters <NUM>, <NUM> to a single dressing <NUM>. The branch adapter <NUM> may be configured to be fluidly coupled to the first canister <NUM> by a first two-pathway conduit <NUM> and configured to be fluidly coupled to the second canister <NUM> by a second two-pathway conduit <NUM>. In some embodiments, the branch adapter <NUM> may be configured to fluidly couple both the first two-pathway conduit <NUM> and second two-pathway conduit <NUM> to a third (e.g. output) two-pathway conduit. In some embodiments, each two-pathway conduit may comprise a negative-pressure pathway and a pressure-sensing pathway, and the negative-pressure pathways may all be fluidly isolated from the pressure-sensing pathways. In some embodiments, the negative-pressure pathway of the first two-pathway conduit <NUM> and the negative-pressure pathway of the second two-pathway conduit <NUM> may both be fluidly coupled by the branch adapter <NUM> to (e.g. merged into) the negative-pressure pathway of the third (e.g. output) two-pathway conduit; and the pressure-sensing pathway of the first two-pathway conduit <NUM> and the pressure-sensing pathway of the second two-pathway conduit <NUM> may be fluidly coupled by the branch adapter <NUM> to (e.g. merged into) the pressure-sensing pathway of the third (e.g. output) two-pathway conduit. In some embodiments, the third (e.g. output) two-pathway conduit may fluidly couple to the single dressing <NUM>.

In some embodiments, the branch adapter <NUM> may comprise branch valves <NUM> (e.g. not shown here, but illustrated in <FIG>) configured to be open under negative-pressure but to close in the absence of negative-pressure. For example, when there is negative pressure in the negative-pressure pathway of the first two-pathway conduit <NUM> and/or the second two-pathway conduit <NUM>, the corresponding branch valve <NUM> for such two-pathway conduit may be open, while the absence of negative pressure in such two-pathway conduit may close the corresponding branch valve <NUM>. In some embodiments, the branch valves <NUM> may comprise butterfly valves.

<FIG> is a schematic view of an embodiment of the branch adapter <NUM> of <FIG>, illustrating additional details that may be associated with some embodiments. In some embodiments, the branch adapter <NUM> may comprise a first conduit coupler <NUM>, a second conduit coupler <NUM>, and a third conduit coupler <NUM>. In some embodiments, the first conduit coupler <NUM> may be configured to fluidly couple to the first two-pathway conduit <NUM>, the second conduit coupler <NUM> may be configured to fluidly couple to the second two-pathway conduit <NUM>, and the third conduit coupler <NUM> may be configured to fluidly couple to the third two-pathway conduit <NUM>. In some embodiments, the first conduit coupler <NUM> may comprise a first negative-pressure pathway <NUM> and a first pressure-sensing pathway <NUM>, configured to fluidly couple to the negative-pressure pathway and the pressure-sensing pathway of the first two-pathway conduit <NUM> (e.g. the first pathway <NUM> and the second pathway <NUM>) respectively. In some embodiments, the second conduit coupler <NUM> may comprise a second negative-pressure pathway <NUM> and second pressure-sensing pathway <NUM>, configured to fluidly couple to the negative-pressure pathway and the pressure-sensing pathway of the second two-pathway conduit <NUM> (e.g. the third pathway <NUM> and the fourth pathway <NUM>) respectively. In some embodiments, the third conduit coupler <NUM> may comprise a third negative-pressure pathway <NUM> and a third pressure-sensing pathway <NUM>, configured to fluidly couple to the two pathways of the third two-pathway conduit <NUM> respectively. In some embodiments, the first negative-pressure pathway <NUM> and second negative-pressure pathway <NUM> both fluidly couple to the third (e.g. output) negative-pressure pathway <NUM>. In some embodiments, the first pressure-sensing pathway <NUM> and the second pressure-sensing pathway <NUM> both fluidly couple to the third pressure-sensing pathway <NUM>. In some embodiments, the negative-pressure pathways may be fluidly isolated from the pressure-sensing pathways within the branch adapter <NUM>. For example, the first, second, and third negative-pressure pathways <NUM>, <NUM>, <NUM> may be fluidly isolated from the first, second, and third pressure-sensing pathways <NUM>, <NUM>, <NUM>.

In some embodiments, the first conduit coupler <NUM> may comprise at least one branch valve <NUM> configured to open when the first conduit coupler <NUM> experiences negative pressure (e.g. when there is negative pressure in the first two-pathway conduit <NUM> attached thereto) and to close in the absence of negative-pressure; and the second conduit coupler <NUM> may comprise at least one branch valve <NUM> configured to open when the second conduit coupler <NUM> experiences negative pressure (e.g. when there is negative pressure in the second two-pathway conduit <NUM> attached thereto) and to close in the absence of negative-pressure. In some embodiments, the at least one branch valve <NUM> for the first conduit coupler <NUM> may be configured to close both the first negative-pressure pathway <NUM> and the first pressure-sensing pathway <NUM>, and the at least one branch valve <NUM> for the second conduit coupler <NUM> may be configured to close both the second negative-pressure pathway <NUM> and the second pressure-sensing pathway <NUM>. In some embodiments, each of the first negative-pressure pathway <NUM>, the first pressure-sensing pathway <NUM>, the second negative-pressure pathway <NUM>, and the second pressure-sensing pathway <NUM> may comprise a branch valve <NUM>. In some embodiments, the first, second, and third conduit couplers <NUM>, <NUM>, <NUM> may each comprise a removable attachment device <NUM> for removably coupling the respective conduits to the corresponding conduit coupler.

<FIG> is a schematic view of another embodiment of the branch adapter <NUM>, illustrating additional details that may be associated with some embodiments. The branch adapter <NUM> of <FIG> may be similar to that of <FIG>, but the second conduit coupler <NUM> may not comprise any pressure-sensing pathway (e.g. being configured to couple to a single-pathway conduit <NUM> having only negative pressure, similar to <FIG>). In some embodiments, the branch adapter <NUM> may be configured to be fluidly coupled to the first canister <NUM> by a first two-pathway conduit <NUM> and fluidly coupled to the second canister <NUM> by a negative-pressure conduit (e.g. the single-pathway conduit <NUM>, without pressure-sensing), and the branch adapter <NUM> may be configured to fluidly couple the negative-pressure conduit (e.g. the single-pathway conduit <NUM>) and a negative-pressure pathway of the first two-pathway conduit <NUM> to a negative-pressure pathway of a third (e.g. output) two-pathway conduit <NUM>. In some embodiments, the branch adapter <NUM> may be configured to fluidly couple a pressure-sensing pathway of the first two-pathway conduit <NUM> to a pressure-sensing pathway of the third (e.g. output) two-pathway conduit <NUM>. In some embodiments, the second conduit coupler <NUM> may only comprise a second negative-pressure pathway <NUM>, which may be configured to fluidly couple to the negative-pressure conduit (e.g. the single-pathway conduit <NUM>). In some embodiments, the first negative-pressure pathway <NUM> and the second negative-pressure pathway <NUM> may fluidly couple to the third (e.g. output) negative-pressure pathway <NUM>, and the first pressure-sensing pathway <NUM> may fluidly couple to the third (e.g. output) pressure-sensing pathway <NUM>. In some embodiments, the first, second, and third negative-pressure pathways <NUM>, <NUM>, <NUM> may be fluidly isolated from the first and third (e.g. output) pressure-sensing pathways <NUM>, <NUM>.

Methods for using disclosed devices and systems are also disclosed herein. Such methods may comprise replacing one canister without interrupting negative-pressure therapy (e.g. while continuing to use another canister to collect exudate). In some embodiments, replacing one canister may comprise detaching the one canister (e.g. from a multi-canister module) and attaching a replacement canister. In some embodiments, the replacement canister may be a new canister substantially the same as the detached canister. In other embodiments, the replacement canister may be the detached canister after being emptied and/or cleaned. In some embodiments, detaching the one canister may seal the negative-pressure port and/or the pressure-sensing port for (e.g. corresponding to) the one canister, thereby allowing continued negative-pressure therapy through the other canister. In some embodiments, detaching the one canister may seal a corresponding conduit coupler on a branch adapter. In some embodiments, the method may further comprise fluidly coupling a multi-canister module to a therapy unit configured for use with only a single canister (e.g. to retrofit the therapy unit for use with multiple canisters). In some embodiments, this may be accomplished by fluidly coupling the multi-canister module to the therapy unit using a therapy unit adapter.

The systems, apparatuses, and methods described herein may provide significant advantages. For example, embodiments may allow for an increase in exudate storage (e.g. by adding one or more additional canisters for increased capacity). Some embodiments may allow for continued negative-pressure therapy, even as one of the canisters is changed and/or emptied (e.g. using the remaining canister to continue therapy in the interim). Such embodiments may improve patient usage, especially at night, by allowing for increased time between changes and reduced patient impact during changes, and thus may allow for improved patient sleep. Improving the uninterrupted sleep of the patient may aid in healing and recovery. Some embodiments may allow a single therapy unit to be used with two or more canisters and/or for two or more tissue sites on a patient. Some embodiments may allow for retrofitting of an existing single canister therapy unit, in order to allow it to be used with two or more canisters simultaneously. Some embodiments may allow for distinct pressure sensing at two or more wound sites, which may provide greater negative pressure control options. Some embodiments may be able to control negative-pressure for the therapy in response to the two or more distinct sensed pressures. In some embodiments, the multi-canister module may be configured so that exudate does not enter the module, allowing the multi-canister module to be reusable for different patients.

If something is described as "exemplary" or an "example", it should be understood that refers to a non-exclusive example. The terms "about" or "approximately" or the like, when used with a number, may mean that specific number, or alternatively, a range in proximity to the specific number as understood by persons of skill in the art field (for example, +/-<NUM>%). Use of broader terms such as "comprises", "includes", and "having" should be understood to provide support for narrower terms such as "consisting of", "consisting essentially of", and "comprised substantially of". Use of the term "optionally", "may", "might", "possibly", "could", "can", "would", "should", "preferably", "typically", "often" and the like with respect to any element, component, feature, characteristic, etc. of an embodiment means that the element, component, feature, characteristic, etc. is not required, or alternatively, the element, component, feature, characteristic, etc. is required, both alternatives being within the scope of the embodiment(s). Such element, component, feature, characteristic, etc. may be optionally included in some embodiments, or it may be excluded (e.g. forming alternative embodiments, all of which are included within the scope of disclosure). Section headings used herein are provided for consistency and convenience, and shall not limit or characterize any invention(s) set out in any claims that may issue from this disclosure. If a reference numeral is used to reference a specific example of a more general term, then that reference numeral may also be used to refer to the general term (or vice versa).

Claim 1:
A device for use in negative-pressure therapy, comprising:
an input negative-pressure port (<NUM>) configured to be fluidly coupled to a negative-pressure source (<NUM>);
a therapy pressure-sensing port (<NUM>) configured to be fluidly coupled to an external pressure sensor (<NUM>);
a first receptor configured for removable attachment of a first canister (<NUM>);
a second receptor configured for removable attachment of a second canister (<NUM>);
a first negative-pressure port (<NUM>) fluidly coupled to the input negative-pressure port (<NUM>);
a first pressure-sensing port (<NUM>) fluidly coupled to the therapy pressure-sensing port (<NUM>);
a second negative-pressure port (<NUM>) fluidly coupled to the input negative-pressure port (<NUM>);
the first negative-pressure port (<NUM>) and the second negative-pressure port (<NUM>) both fluidly coupled to the input negative-pressure port (<NUM>), such that negative-pressure from the input negative-pressure port (<NUM>) is distributed to the first negative-pressure port (<NUM>) and the second negative-pressure port (<NUM>);
the first receptor comprising a first releasable latch mechanism (<NUM>); and
the second receptor comprising a second releasable latch mechanism (<NUM>);
wherein the second receptor is configured so that, when the second canister (<NUM>) is attached, the second negative-pressure port (<NUM>) is open; but when the second canister (<NUM>) is not attached, the second negative-pressure port (<NUM>) is closed.