WO2021070046A1

WO2021070046A1 - Instillation system with fluid confirmation

Info

Publication number: WO2021070046A1
Application number: PCT/IB2020/059367
Authority: WO
Inventors: Christopher Brian Locke; Benjamin Andrew Pratt
Original assignee: Kci Licensing, Inc.
Priority date: 2019-10-07
Filing date: 2020-10-06
Publication date: 2021-04-15

Abstract

Disclosed systems may relate to instillation therapy, which may for example be used with negative-pressure therapy of a tissue site. An instillation sensor module may be configured to sense instillation fluid before delivery to the tissue site. In some embodiments, a plurality of instillation fluid sources may be in fluid communication with the instillation sensor module, for sequential or simultaneous delivery. A controller may use the data from the instillation sensor module to monitor and/or control delivery of instillation fluid.

Description

INSTILLATION SYSTEM WITH FLUID CONFIRMATION

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 62/911,625, filed on October 7, 2019, which is incorporated herein by reference in its entirety.

TECHNICAL FIELD

[0002] The invention set forth in the appended claims relates generally to tissue treatment systems and more particularly, but without limitation, to systems and methods for providing negative- pressure therapy and/or instillation of the tissue site.

BACKGROUND

[0003] Clinical studies and practice have shown that reducing pressure in proximity to a tissue site can augment and accelerate growth of new tissue at the tissue site. The applications of this phenomenon are numerous, but it has proven particularly advantageous for treating wounds. Regardless of the etiology of a wound, whether trauma, surgery, or another cause, proper care of the wound is important to the outcome. Treatment of wounds or other tissue with reduced pressure may be commonly referred to as "negative-pressure therapy," but is also known by other names, including "negative- pressure wound therapy," "reduced-pressure therapy," "vacuum therapy," "vacuum-assisted closure," and "topical negative-pressure," for example. Negative-pressure therapy may provide a number of benefits, including migration of epithelial and subcutaneous tissues, improved blood flow, and micro deformation of tissue at a wound site. Together, these benefits can increase development of granulation tissue and reduce healing times.

[0004] 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.

[0005] 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. BRIEF SUMMARY

[0006] New and useful systems, apparatuses, and methods for treating tissue in a negative- pressure therapy environment are set forth in the appended claims. Illustrative embodiments are also provided to enable a person skilled in the art to make and use the claimed subject matter.

[0007] For example, in some embodiments, instillation systems may comprise a means to detect fluid being delivered and to confirm that the proper instillation fluid is being delivered. For example, the detector may be in fluid communication with at least one instillation fluid source, and may comprise an FTIR device configured to sense the fluid from the instillation fluid source prior to delivery to the dressing and/or tissue site. The detector may be configured to sense the type and/or concentration of fluids being delivered. The detector may be communicatively coupled to a processor, which may be configured to analyze the sensed data from the detector to determine the type of fluid. Some embodiments may further include a multi-channel fluid delivery system, configured to allow instillation from more than one instillation fluid source. For example, this may allow the instillation system to use more than one type of instillation fluid in accordance with a regime and/or in a sequence. In some embodiments, different fluids from two or more sources may be mixed, and the detector may confirm that the concentration of the fluid mixture is correct. In some embodiments, the detector may confirm that the appropriate instillation fluid is being delivered at the appropriate time, and may even issue an alert and/or stop delivery of instillation fluid if the sensed data from the detector indicates the presence of improper fluid. In some embodiments each of the plurality of fluid delivery channels may comprise a peristaltic pump head, while in other embodiments, a single pump may operate with a selection valve to allow delivery of the plurality of instillation fluids. In some embodiments, a buffer may allow the detector to operate without contamination, by ensuring that the detector is not directly exposed to the fluids.

[0008] More generally, systems for treating a tissue site may comprise: an instillation sensor module; at least one channel, each of the at least one channel comprising a fluid container; a controller communicatively coupled to the instillation sensor module and the at least one channel; and a negative- pressure therapy unit. In some embodiments, the instillation sensor module may comprise: at least one input port; an output port; a flowpath between the at least one input port and the output port; and a detector configured to sense fluid in the flowpath and generate sensed data. In some embodiments, the detector may be communicatively coupled to the controller. In some embodiments, the at least one channel may be fluidly coupled to one of the at least one input port. In some embodiments, the detector may be configured to sense chemical composition and/or concentration of the fluid. For example, the detector may comprise an FTIR detector. In some embodiments, each of the at least one input port may comprise a one-way valve configured to prevent backflow from the flowpath. The instillation sensor module may in some embodiments further comprise a buffer located between the detector and the flowpath, wherein the buffer is configured to shield the detector from direct expose to fluid in the flowpath without significantly impacting sensing of the fluid. In some embodiments, the flowpath may comprise a mixing chamber. For example, the mixing chamber may comprise a mixing element. Some system embodiments may further comprise a dressing interface, wherein the output port is in fluid communication with the dressing interface, and the NP therapy unit is in fluid communication with the dressing interface.

[0009] In some embodiments, the at least one channel may comprise a plurality of channels, and the at least one input port may comprise a plurality of input ports. In some embodiments, each of the at least one channel may comprise: a pump configured to direct fluid from the fluid container to one of the at least one input port; and an actuator configured to operate the pump. In alternate embodiments, the at least one channel may comprise a plurality of channels, and the system may further comprise a single pump and a selection valve between the pump and the plurality of fluid containers operable to selectively place the pump in fluid communication with each of the plurality of fluid containers. Some embodiments may further comprise a pump actuator communicatively coupled to the controller and configured to operate the pump responsive to instructions from the controller, and a switch actuator communicatively coupled to the controller and configured to operate the selection valve based on instructions from the controller. In some embodiments, for each of the at least one channel, the pump may comprise a peristaltic pump. In some embodiments, the fluid container for each of the plurality of channels may comprise a different instillation fluid.

[0010] Some controller embodiments may comprise a wireless transceiver configured to receive sensed data from the detector and to transmit instructions to the one or more pump (e.g. via the actuator for the pump) based on the sensed data and/or the protocol. In some embodiments, the controller may direct instillation from one or more of the plurality of fluid containers based on a protocol. In some embodiments, the protocol may direct fluid delivery from one or more of the channels based on the sensed data and/or the protocol. For example, the protocol may direct sequential pumping of instillation fluid from the plurality of channels and/or simultaneous pumping of instillation fluid from the plurality of channels for mixing within the flowpath. In some embodiments, the controller may activate an alert if the sensed data chemical composition does not match the protocol. In some embodiments, the controller may direct the pump for one or more of the at least one channel to stop if the sensed data chemical composition does not match the protocol. In some embodiments, the controller may direct the pump for one or more of the at least one channel to alter flowrate if the sensed data concentration does not match the protocol. In some embodiments, the controller may be configured to compare the sensed data to a look-up table to determine the chemical composition of the fluid in the flowpath. In some embodiments, the controller may be configured to determine concentration of fluids in the flowpath (e.g. when there is a mixture of a plurality of fluids in the flowpath). In some embodiments, the controller may be configured to determine the identity of the fluids in each channel based on sensed data from the detector.

[0011] Some system embodiments may further comprise one or more fluid flow sensors configured to detect fluid flow issues (e.g. blockage of flow, engagement of the channel, and/or bubbles in the channel) with respect to each of the at least one channel. In some embodiments, the fluid instillation container may be configured for use with a cartridge having a mounting location and the one or more fluid flow sensors. The negative-pressure therapy unit of some systems may comprise the controller, and the controller may be configured to operate both instillation and negative-pressure therapy. Some embodiments may further comprise a RAMAN sensor configured to monitor fluid removed via the dressing interface during negative-pressure therapy.

[0012] Alternatively, other example system embodiments (for example just pertaining to instillation) may comprise: an instillation sensor module; at least one channel fluidly coupled to one of the at least one input port, each of the at least one channel comprising a fluid container; and a controller communicatively coupled to the instillation sensor module (e.g. the detector) and the at least one channel. In some embodiments, the instillation sensor module may comprise at least one input port; an output port; a flowpath between the at least one input port and the output port; and a detector configured to sense fluid in the flowpath and generate sensed data. In some embodiments, the detector may comprise an FTIR detector or a RAMAN sensor. In some embodiments, each of the at least one channel may comprise a pump (e.g. a peristaltic pump) configured to direct fluid from the fluid container to the input port; and an actuator configured to operate the pump. Some embodiments of the system may comprise a plurality of channels and/or a plurality of input ports. In some embodiments with a plurality of channels, the system may further comprise a single pump and a selection valve between the pump and the plurality of fluid containers operable to selectively place the pump in fluid communication with each of the plurality of fluid containers. Some embodiments may further comprise a pump actuator communicatively coupled to the controller and configured to operate the pump responsive to instructions from the controller, and a switch actuator communicatively coupled to the controller and configured to operate the selection valve based on instructions from the controller. The fluid container for each of the plurality of channels may comprise a different instillation fluid, in some embodiments.

[0013] In some embodiments, each of the at least one input port may comprise a breachable seal, each of the at least one channel may comprise a conduit, each conduit may comprise a connector end, and each connector end may be configured to breach the breachable seal upon connection and to removably attach the conduit to the input port for fluid communication therebetween. Some system embodiments may further comprise one or more fluid flow sensors configured to detect fluid flow issues with respect to the container. In some embodiments, each (instillation) fluid container may be configured for use with a cartridge having a mounting location and the one or more fluid flow sensors. Some embodiments may further comprise a dressing interface in fluid communication with the output port.

[0014] In some embodiments, the controller may comprise a wireless transceiver configured to receive sensed data from the detector and to transmit instructions to the pump based on the sensed data and/or a protocol. In some embodiments, the controller may be configured to direct instillation from one or more of the plurality of fluid containers based on a protocol (e.g. the protocol may direct fluid delivery from one or more of the channels based on the sensed data and/or the protocol). For example, the protocol may direct sequential pumping of instillation fluid from the plurality of channels and/or simultaneous pumping of instillation fluid from two or more of the plurality of channels. In some embodiments, the protocol may activate an alert if the sensed data chemical composition does not match the protocol. In some embodiments, the protocol may direct the pump for one or more of the at least one channel to stop if the sensed data chemical composition does not match the protocol. In some embodiments, the protocol may direct the pump for one or more of the at least one channel to alter flowrate if the sensed data concentration does not match the protocol. In some embodiments, the controller may determine the identity of the fluids in each channel based on sensed data from the detector.

[0015] Embodiments of an instillation sensor module are also described herein. For example, instillation sensor module embodiments may comprise: at least one input port; an output port; a flowpath between the at least one input port and the output port; and a detector configured to sense fluid in the flowpath and generate sensed data. The detector may be configured to sense chemical composition and/or concentration, in some embodiments. The detector may, for example, comprise an FTIR detector or a RAMAN sensor. In some embodiments, the at least one input port may comprise a plurality of input ports, each configured to receive fluid from a channel. In some embodiments, each of the at least one input port may comprise a one-way valve configured to prevent backflow from the flowpath. Some embodiments may further comprise a buffer located between the detector and the flowpath, wherein the buffer is configured to shield the detector from direct expose to fluid in the flowpath without significantly impacting sensing of the fluid. In some embodiments, each of the at least one input port may comprise a breachable seal. The flowpath in some embodiments may comprise a mixing chamber configured to mix two or more fluids simultaneously flowing into the instillation sensor module through two or more of the plurality of input ports. In some embodiments, the detector may be communicatively coupled to a controller and configured to transmit sensed data to the controller (e.g. the detector may comprise a wireless transmitter).

[0016] Objectives, advantages, and a preferred mode of making and using the claimed subject matter may be understood best by reference to the accompanying drawings in conjunction with the following detailed description of illustrative embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 is a functional block diagram of an example embodiment of a therapy system that can provide negative-pressure treatment and instillation treatment in accordance with this specification;

[0018] Figure 2 is a graph illustrating additional details of example pressure control modes that may be associated with some embodiments of the therapy system of Figure 1;

[0019] Figure 3 is a graph illustrating additional details that may be associated with another example pressure control mode in some embodiments of the therapy system of Figure 1; [0020] Figure 4 is a chart illustrating details that may be associated with an example method of operating the therapy system of Figure 1;

[0021] Figure 5 is a schematic view of an embodiment of a negative-pressure therapy system with instillation, illustrating additional details that may be associated with some embodiments of the therapy system of Figure 1 ;

[0022] Figure 6 is a schematic view of an exemplary embodiment of an instillation sensor module, illustrating additional details that may be associated with some embodiments;

[0023] Figure 7 is a schematic view of an alternative embodiment of a negative-pressure therapy system with instillation, illustrating additional details that may be associated with some embodiments of the therapy system of Figure 1 ; and

[0024] Figure 8 is a schematic isometric view of an exemplary embodiment of the system of Figure 5, illustrating additional details that may be associated with some embodiments.

DESCRIPTION OF EXAMPLE EMBODIMENTS

[0025] The following description of example embodiments provides information that enables a person skilled in the art to make and use the subject matter set forth in the appended claims, but it may omit certain details already well-known in the art. The following detailed description is, therefore, to be taken as illustrative and not limiting.

[0026] The example embodiments may also be described herein with reference to spatial relationships between various elements or to the spatial orientation of various elements depicted in the attached drawings. In general, such relationships or orientation assume a frame of reference consistent with or relative to a patient in a position to receive treatment. However, as should be recognized by those skilled in the art, this frame of reference is merely a descriptive expedient rather than a strict prescription.

[0027] Figure 1 is a simplified functional block diagram of an example embodiment of a therapy system 100 that can provide negative -pressure therapy with instillation of topical treatment solutions to a tissue site in accordance with this specification.

[0028] 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.

[0029] The therapy system 100 may include a source or supply of negative pressure, such as a negative-pressure source 105, 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 110, and a fluid container, such as an exudate container 115, are examples of distribution components that may be associated with some examples of the therapy system 100. As illustrated in the example of Figure 1, the dressing 110 may comprise or consist essentially of a tissue interface 120, a cover 125, or both in some embodiments.

[0030] A fluid conductor is another illustrative example of a distribution component. A “fluid conductor,” in this context, broadly includes a tube, pipe, hose, conduit, or other structure with one or more lumina or open pathways adapted to convey a fluid between two ends. Typically, a tube is an elongated, cylindrical structure with some flexibility, but the geometry and rigidity may vary. Moreover, some fluid conductors may be molded into or otherwise integrally combined with other components. Distribution components may also include or comprise interfaces or fluid ports to facilitate coupling and de-coupling other components. In some embodiments, for example, a dressing interface may facilitate coupling a fluid conductor to the dressing 110. For example, such a dressing interface may be a SENSAT.R.A.C.™ Pad available from Kinetic Concepts, Inc. of San Antonio, Texas.

[0031] The therapy system 100 may also include a regulator or controller, such as a controller 130. Additionally, the therapy system 100 may include sensors to measure operating parameters and provide feedback signals to the controller 130 indicative of the operating parameters. As illustrated in Figure 1, for example, the therapy system 100 may include a first sensor 135 and a second sensor 140 coupled to the controller 130.

[0032] The therapy system 100 may also include a source of instillation solution. For example, a solution source 145 may be fluidly coupled to the dressing 110, as illustrated in the example embodiment of Figure 1. The solution source 145 may be fluidly coupled to a positive-pressure source, such as a positive-pressure source 150, a negative-pressure source such as the negative-pressure source 105, or both in some embodiments. A regulator, such as an instillation regulator 155, may also be fluidly coupled to the solution source 145 and the dressing 110 to ensure proper dosage of instillation solution (e.g. saline) to a tissue site. For example, the instillation regulator 155 may comprise a piston that can be pneumatically actuated by the negative-pressure source 105 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 130 may be coupled to the negative-pressure source 105, the positive-pressure source 150, or both, to control dosage of instillation solution to a tissue site. In some embodiments, the instillation regulator 155 may also be fluidly coupled to the negative-pressure source 105 through the dressing 110, as illustrated in the example of Figure 1.

[0033] Some embodiments of the therapy system 100 may include an instillation sensor module 160, configured to receive instillation fluid and sense it prior to delivery to the dressing 110. In some embodiments, the instillation sensor module 160 may be in fluid communication with the solution source 145 and the dressing 110. For example, the instillation sensor module 160 may be configured so that it may detect any instillation fluid prior to delivery of instillation fluid to the dressing 110. In some embodiments, the instillation sensor module 160 may be configured to sense the composition and/or concentration of the instillation fluid from the solution source 145, for example allowing confirmation of the fluid type prior to application to the tissue site.

[0034] Some components of the therapy system 100 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 105 may be combined with the controller 130, the solution source 145, and/or other components into a therapy unit.

[0035] In general, components of the therapy system 100 may be coupled directly or indirectly. For example, the negative-pressure source 105 may be directly coupled to the container 115 and may be indirectly coupled to the dressing 110 through the container 115. Coupling may include fluid, mechanical, thermal, electrical, or chemical coupling (such as a chemical bond), or some combination of coupling in some contexts. For example, the negative-pressure source 105 may be electrically coupled to the controller 130 and may be fluidly coupled to one or more distribution components to provide a fluid path to a tissue site. In some embodiments, components may also be coupled by virtue of physical proximity, being integral to a single structure, or being formed from the same piece of material.

[0036] A negative-pressure supply, such as the negative-pressure source 105, 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 105 may vary according to therapeutic requirements, the pressure is generally a low vacuum, also commonly referred to as a rough vacuum, between -5 mm Hg (-667 Pa) and -500 mm Hg (-66.7 kPa). Common therapeutic ranges are between -50 mm Hg (-6.7 kPa) and -300 mm Hg (-39.9 kPa).

[0037] The container 115 is representative of a container, canister, pouch, or other storage component, which can be used to manage exudates and other fluids withdrawn from a tissue site. In many environments, a rigid container may be preferred or required for collecting, storing, and disposing of fluids. In other environments, fluids may be properly disposed of without rigid container storage, and a re-usable container could reduce waste and costs associated with negative-pressure therapy. [0038] A controller, such as the controller 130, may be a microprocessor or computer programmed to operate one or more components of the therapy system 100, such as the negative- pressure source 105. In some embodiments, for example, the controller 130 may be a microcontroller, which generally comprises an integrated circuit containing a processor core and a memory programmed to directly or indirectly control one or more operating parameters of the therapy system 100. Operating parameters may include the power applied to the negative-pressure source 105, the pressure generated by the negative-pressure source 105, or the pressure distributed to the tissue interface 120, for example. The controller 130 is also preferably configured to receive one or more input signals, such as a feedback signal, and programmed to modify one or more operating parameters based on the input signals.

[0039] Sensors, such as the first sensor 135 and the second sensor 140, are generally known in the art as any apparatus operable to detect or measure a physical phenomenon or property, and generally provide a signal indicative of the phenomenon or property that is detected or measured. For example, the first sensor 135 and the second sensor 140 may be configured to measure one or more operating parameters of the therapy system 100. In some embodiments, the first sensor 135 may be a transducer configured to measure pressure in a pneumatic pathway and convert the measurement to a signal indicative of the pressure measured. In some embodiments, for example, the first sensor 135 may be a piezo-resistive strain gauge. The second sensor 140 may optionally measure operating parameters of the negative-pressure source 105, such as a voltage or current, in some embodiments. Preferably, the signals from the first sensor 135 and the second sensor 140 are suitable as an input signal to the controller 130, but some signal conditioning may be appropriate in some embodiments. For example, the signal may need to be filtered or amplified before it can be processed by the controller 130. Typically, the signal is an electrical signal, but may be represented in other forms, such as an optical signal.

[0040] The tissue interface 120 can be generally adapted to partially or fully contact a tissue site. The tissue interface 120 may take many forms, and may have many sizes, shapes, or thicknesses, depending on a variety of factors, such as the type of treatment being implemented or the nature and size of a tissue site. For example, the size and shape of the tissue interface 120 may be adapted to the contours of deep and irregular shaped tissue sites. Any or all of the surfaces of the tissue interface 120 may have an uneven, coarse, or jagged profile.

[0041] In some embodiments, the tissue interface 120 may comprise or consist essentially of a manifold. A manifold in this context may comprise or consist essentially of a means for collecting or distributing fluid across the tissue interface 120 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 120, 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. [0042] 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.

[0043] In some embodiments, the tissue interface 120 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 90% may be suitable for many therapy applications, and foam having an average pore size in a range of 400-600 microns (40-50 pores per inch) may be particularly suitable for some types of therapy. The tensile strength of the tissue interface 120 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 25% compression load deflection of the tissue interface 120 may be at least 0.35 pounds per square inch, and the 65% compression load deflection may be at least 0.43 pounds per square inch. In some embodiments, the tensile strength of the tissue interface 120 may be at least 10 pounds per square inch. The tissue interface 120 may have a tear strength of at least 2.5 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 120 may be reticulated polyurethane foam such as found in GRANUFOAM™ dressing or V.A.C. VERAFLO™ dressing, both available from Kinetic Concepts, Inc. of San Antonio, Texas.

[0044] The thickness of the tissue interface 120 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 120 can also affect the conformability of the tissue interface 120. In some embodiments, a thickness in a range of about 5 millimeters to 10 millimeters may be suitable.

[0045] The tissue interface 120 may be either hydrophobic or hydrophilic. In an example in which the tissue interface 120 may be hydrophilic, the tissue interface 120 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 120 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.A.C. WHITEFOAM™ dressing available from Kinetic Concepts, Inc. of San Antonio, Texas. 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.

[0046] In some embodiments, the tissue interface 120 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 120 may further serve as a scaffold for new cell-growth, or a scaffold material may be used in conjunction with the tissue interface 120 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.

[0047] In some embodiments, the cover 125 may provide a bacterial barrier and protection from physical trauma. The cover 125 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 125 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 125 may have a high moisture-vapor transmission rate (MVTR) in some applications. For example, the MVTR may be at least 250 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 38°C and 10% relative humidity (RH). In some embodiments, an MVTR up to 5,000 grams per square meter per twenty-four hours may provide effective breathability and mechanical properties.

[0048] In some example embodiments, the cover 125 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 25-50 microns. For permeable materials, the permeability generally should be low enough that a desired negative pressure may be maintained. The cover 125 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 3M Company, Minneapolis Minnesota; polyurethane (PU) drape, commercially available from Avery Dennison Corporation, Pasadena, California; polyether block polyamide copolymer (PEBAX), for example, from Arkema S.A., Colombes, France; and Inspire 2301 and Inpsire 2327 polyurethane films, commercially available from Transcontinental Advanced Coating, Wrexham, United Kingdom. In some embodiments, the cover 125 may comprise INSPIRE 2301 having an MVTR (upright cup technique) of 2600 g/m²/24 hours and a thickness of about 30 microns.

[0049] An attachment device may be used to attach the cover 125 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 125 to epidermis around a tissue site. In some embodiments, for example, some or all of the cover 125 may be coated with an adhesive, such as an acrylic adhesive, which may have a coating weight of about 25-65 grams per square meter (g.s.m.). 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.

[0050] The solution source 145 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 (0.5%), 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 114 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 150, such as a V.A.C. VeraLink™ Cassette available from Kinetic Concepts, Inc. of San Antonio, Texas.

[0051] In operation, the tissue interface 120 may be placed within, over, on, or otherwise proximate to a tissue site. If the tissue site is a wound, for example, the tissue interface 120 may partially or completely fill the wound, or it may be placed over the wound. The cover 125 may be placed over the tissue interface 120 and sealed to an attachment surface near a tissue site. For example, the cover 125 may be sealed to undamaged epidermis peripheral to a tissue site. Thus, the dressing 110 can provide a sealed therapeutic environment proximate to a tissue site, substantially isolated from the external environment, and the negative-pressure source 105 can reduce pressure in the sealed therapeutic environment.

[0052] The fluid mechanics of using a negative-pressure source to reduce pressure in another component or location, such as within a sealed therapeutic environment, can be mathematically complex. However, the basic principles of fluid mechanics applicable to negative-pressure therapy and instillation are generally well-known to those skilled in the art, and the process of reducing pressure may be described illustratively herein as “delivering,” “distributing,” or “generating” negative pressure, for example.

[0053] In general, exudate and other fluid flow toward lower pressure along a fluid path. Thus, the term “downstream” typically implies something 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” implies something 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 this descriptive convention should not be construed as a limiting convention.

[0054] Negative pressure applied across the tissue site through the tissue interface 120 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 115.

[0055] In some embodiments, the controller 130 may receive and process data from one or more sensors, such as the first sensor 135. The controller 130 may also control the operation of one or more components of the therapy system 100 to manage the pressure delivered to the tissue interface 120. In some embodiments, controller 130 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 120. 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 130. 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 130 can operate the negative -pressure source 105 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 120.

[0056] Figure 2 is a graph illustrating additional details of an example control mode that may be associated with some embodiments of the controller 130. In some embodiments, the controller 130 may have a continuous pressure mode, in which the negative-pressure source 105 is operated to provide a constant target negative pressure, as indicated by line 205 and line 210, 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 Figure 2. In Figure 2, the x-axis represents time and the y-axis represents negative pressure generated by the negative-pressure source 105 over time. In the example of Figure 2, the controller 130 can operate the negative-pressure source 105 to cycle between a target pressure and atmospheric pressure. For example, the target pressure may be set at a value of 135 mmHg, as indicated by line 205, for a specified period of time (e.g., 5 min), followed by a specified period of time (e.g., 2 min) of deactivation, as indicated by the gap between the solid lines 215 and 220. The cycle can be repeated by activating the negative-pressure source 105, as indicated by line 220, which can form a square wave pattern between the target pressure and atmospheric pressure. [0057] 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 105 and the dressing 110 may have an initial rise time, as indicated by the dashed line 225. 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 20-30 mmHg/second and in a range of about 5-10 mmHg/second for another therapy system. If the therapy system 100 is operating in an intermittent mode, the repeating rise time, as indicated by the solid line 220, may be a value substantially equal to the initial rise time as indicated by the dashed line 225.

[0058] Figure 3 is a graph illustrating additional details that may be associated with another example pressure control mode in some embodiments of the therapy system 100. In Figure 3, the x- axis represents time and the y-axis represents negative pressure generated by the negative-pressure source 105. The target pressure in the example of Figure 3 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 50 and 135 mmHg with a rise time 305 set at a rate of +25 mmHg/min. and a descent time 310 set at -25 mmHg/min. In other embodiments of the therapy system 100, the triangular waveform may vary between negative pressure of 25 and 135 mmHg with a rise time 305 set at a rate of +30 mmHg/min and a descent time 310 set at -30 mmHg/min.

[0059] In some embodiments, the controller 130 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 130, 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.

[0060] Figure 4 is a chart illustrating details that may be associated with an example method 400 of operating the therapy system 100 to provide negative-pressure treatment and instillation treatment to the tissue interface 120. In some embodiments, the controller 130 may receive and process data, such as data related to instillation solution provided to the tissue interface 120. 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 10 and 500 mL, and the dwell time may be between one second to 30 minutes. The controller 130 may also control the operation of one or more components of the therapy system 100 to instill solution, as indicated at 405. For example, the controller 130 may manage fluid distributed from the solution source 145 to the tissue interface 120. In some embodiments, fluid may be instilled to a tissue site by applying a negative pressure from the negative-pressure source 105 to reduce the pressure at the tissue site, drawing solution into the tissue interface 120, as indicated at 410. In some embodiments, solution may be instilled to a tissue site by applying a positive pressure from the positive- pressure source 160 to move solution from the solution source 145 to the tissue interface 120, as indicated at 415. Additionally or alternatively, the solution source 145 may be elevated to a height sufficient to allow gravity to move solution into the tissue interface 120, as indicated at 420.

[0061] The controller 130 may also control the fluid dynamics of instillation at 425 by providing a continuous flow of solution at 430 or an intermittent flow of solution at 435. Negative pressure may be applied to provide either continuous flow or intermittent flow of solution at 440. The application of negative pressure may be implemented to provide a continuous pressure mode of operation at 445 to achieve a continuous flow rate of instillation solution through the tissue interface 120, or it may be implemented to provide a dynamic pressure mode of operation at 450 to vary the flow rate of instillation solution through the tissue interface 120. Alternatively, the application of negative pressure may be implemented to provide an intermittent mode of operation at 455 to allow instillation solution to dwell at the tissue interface 120. 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 460. The controller 130 may be utilized to select a mode of operation and the duration of the negative pressure treatment before commencing another instillation cycle at 465 by instilling more solution at 405.

[0062] Figure 5 is a schematic view of an embodiment of a negative-pressure therapy system 100 with instillation, illustrating additional details that may be associated with some embodiments of the therapy system of Figure 1. Figure 5 illustrates an exemplary negative-pressure therapy system 100 with instillation, which is configured to allow multi-channel delivery of different instillation fluids. The therapy system 100 for treating a tissue site may comprise the instillation sensor module 160, a plurality of channels 505 (e.g. three channels) fluidly coupled to the instillation sensor module 160, and a negative-pressure therapy unit comprising the negative pressure source 105. The therapy system 100 may be used with a dressing interface 510, which may be fluidly coupled to the instillation sensor module 160 and the negative-pressure source 105. The therapy system 100 may further comprise the controller 130, which may be communicatively coupled to the instillation sensor module 160 and to each of the plurality of channels 505. In the embodiment shown in Figure 5, the controller 130 is a component of the negative-pressure therapy unit (e.g. the negative-pressure therapy unit may comprise the controller 130). In some embodiments, the controller 130 may also be communicatively coupled to and operate the negative-pressure source 105. In some embodiments, the controller 130 may be configured to direct both negative-pressure therapy and instillation. For example, the controller 130 may be configured to operate the negative-pressure source 105 for providing both negative pressure therapy and instillation therapy to the tissue site, or alternatively may provide instillation therapy using positive pressure to provide instillation fluid from the channels 505 to the tissue site and negative- pressure therapy using the negative-pressure source 105. [0063] In some embodiments, the instillation sensor module 160 may comprise at least one input port 515; an output port 520; a module flowpath between the at least one input port 515 and the output port 520; and a detector 525 configured to sense fluid in the module flowpath before delivery to the dressing interface 510 and generate sensed data indicative of the sensed fluid. For example, the detector 525 may be configured to sense chemical composition and/or concentration of fluids in the module flowpath. In the embodiment of Figure 5, the instillation sensor module 160 may comprise a plurality of input ports 515 and/or a number of inputs corresponding to the number of channels, such as the three inputs 515 shown in Figure 5. In some embodiments, each channel 505 may comprise a solution source for instillation fluid, such as instillation fluid container 530 configured to hold instillation fluid, and each channel 505 may be in fluid communication with one of the input ports 515. In some embodiments, each of the channels 505 may comprise a pump 535 configured to force fluid from the corresponding instillation fluid container 530 to one of the input ports 515, and an actuator 540 configured to operate the pump 535. In some embodiments, the pump 535 may comprise a mechanical pumping device, such as a peristaltic pump. In some embodiments, the pump 535 may be gravity operated, for example based on relative height of the instillation container 530 with respect to the instillation sensor module 160 and/or the tissue site. In some embodiments, each channel 505 may also comprise a conduit which may be configured to fluidly couple to one of the input ports 515. In some embodiments, each pump 535 may be operable to run simultaneously. In some embodiments, each of the plurality of pumps 535 may have the same maximum flowrate. In other embodiments, one or more of the pumps 535 may have a different maximum flowrate. In some embodiments, the therapy system 100 may comprise three pumps 535, three instillation fluid containers 530, and/or three input ports 515.

[0064] In some embodiments, the instillation fluid containers 530 may each comprise a different instillation fluid. For example, a first of the plurality of instillation fluid containers 530 may comprises a first instillation fluid, a second of the plurality of instillation fluid containers 530 may comprise a second instillation fluid, and a third of the plurality of instillation fluid containers 530 may comprise a third instillation fluid. In some embodiments, at least one of the instillation fluid containers 530 may comprise a different fluid, and/or at least two of the instillation fluid containers 530 may comprise the same fluid.

[0065] As indicated above, the detector 525 may be configured to sense characteristics of the instillation fluid in the module flowpath, including for example chemical composition (e.g. fluid type) and/or concentration of the fluid (e.g. proportion of different fluids in a mixture), and then to generate sensed data indicative of such characteristics. The detector 525 may be configured to communicate the sensed data to the controller 130, so that the controller 130 may evaluate the sensed data and/or determine if any action is needed in response to the sensed data. In some embodiments, the controller 130 may be programmed with software including algorithms for controlling instillation delivery and/or identifying instillation fluids based on sensed data from the detector 525. In some embodiments, the controller 130 may receive and process sensed data from the detector 525. The controller 130 may be configured to control the operation of one or more components (such as one or more pump and/or a selection valve) to control delivery of instillation fluid to the dressing. For example, the controller 130 may be configured to generate and send instructions to control operation of instillation pumps, such as the instillation pump 535, or selection valves associated with the input ports 515, to control delivery of instillation fluid. In some embodiments, the controller 130 may also be configured to control operation of the negative-pressure source 105, to operate provide negative-pressure therapy to the tissue site and/or to selectively draw instillation fluid to the tissue site for instillation therapy.

[0066] In some embodiments, the controller 130 may determine the identity (e.g. type) of the fluid in each channel 505 based on sensed data from the detector 525. For example, the controller 130 may be configured to compare the sensed data to a look-up table to determine the chemical composition of the fluid in the module flowpath. In some embodiments, the identity of the instillation fluid in each of the channels 505 may be added to the look-up table by sensing a known chemical with the detector 525 and then inputting the chemical/fluid identification. For example, an input device associated with the controller 130 may be used to link the sensed data profile with the fluid type in a look-up table. In some embodiments, the controller 130 may be configured to determine concentration of fluids in the module flowpath based on sensed data. In some embodiments, the controller 130 may be configured to direct instillation from one or more of the plurality of instillation fluid containers 530 based on a pre defined protocol. For example, the controller 130 may comprise a pre-defined protocol, and the controller 130 may direct fluid delivery from one or more of the channels 505 based on the sensed data and/or the protocol. For example, the protocol may direct sequential pumping of instillation fluid from the plurality of channels 505, with the detector sensed data being used to confirm delivery of the right fluid in the right sequence. In some embodiments, the protocol may direct simultaneous pumping of instillation fluid from two or more of the plurality of channels 505 for mixing within the module flowpath and/or to achieve a pre-defined concentration. The controller 130 may direct pumping, in some embodiments, by sending an instruction to the pump via the corresponding pump actuator 540.

[0067] In some embodiments, the controller 130 may activate an alert if the sensed data chemical composition and/or concentration does not match the protocol. For example, responsive to the sensed data not matching the protocol (e.g. a look-up table), the controller 130 may activate an alert or warning device, such as an audio and/or visual alarm. In some embodiments, the controller 130 may direct the pump 535, via the corresponding pump actuator 540, for one or more of the channels 505 to stop if the sensed data chemical composition and/or concentration does not match the protocol. For example, responsive to the sensed data not matching the protocol, the controller 130 may transmit a “stop” instruction to the pump 535 of at least one channel 505. In some embodiments, the controller 130 may direct the pump 535, via the corresponding pump actuator 540, for one or more of the channels 505 to alter flowrate if the sensed data concentration does not match the protocol. For example, responsive to the sensed data not matching the protocol, the controller 130 may transmit an instruction to the pump 535 of at least one channel 505, altering its flowrate/speed. The protocol may be configured to ensure that the fluid delivery is in accordance with what has been clinically prescribed and/or is an approved use. In some embodiments, the protocol and/or look-up table (e.g. database) embodiments may be implemented by software programming and/or algorithms, which may pre-defme the manner in which the controller 130 operates responsive to various conditions and/or sensed data.

[0068] In some embodiments, communication between two or more elements may be wireless. For example, communication between the detector 525 and the controller 130, and/or between the controller 130 and the pump actuator 540, may be wireless. In some embodiments, wireless communication may comprise near-field communication (NFC), Bluetooth® Low Energy system-on- chip (or other Bluetooth® standards), ZigBee®, ANT, Z-Wave, Wireless USB, 3/4 G GSM, and/or WiFi communication. In some embodiments, the controller 130 may comprise a wireless transceiver configured to receive sensed data from the detector 525 and to transmit instructions to the pump 535, for example via the pump actuator 540, based on the sensed data and/or the protocol. For example, responsive to the controller 130 analyzing the received sensed data, the controller 130 may generate instructions to one or more of the plurality of channels 505. The instructions may be generated based on the sensed data and/or the protocol. For example, pre-programmed software may be configured to operate the regime and/or to analyze the sensed data by comparing the sensed data to a database or look up table and determining any required changes. In some embodiments, the detector 525 may comprise a wireless transmitter configured to transmit sensed data to the controller 130. In some embodiments, each pump 535 and/or its actuator 540 may comprise a wireless receiver, configured to receive instructions from the controller 130. For example, each pump actuator 540 may comprise a wireless receiver coupled to a processor and/or a control mechanism, configured to actuate the pump based on instructions from the controller 130.

[0069] Some system embodiments may have only a single channel 505, for example including a single instillation fluid container 530 and a single pump 535, and a single input port 515. In such embodiments, the instillation sensor module 160 and/or controller 130 may be configured to confirm the type of instillation fluid prior to delivery of the instillation fluid to the tissue site. Some system embodiments may be configured to only provide instillation therapy, wherein the system comprises only instillation components including the controller 130 configured only to apply instillation fluids to the tissue site (as further illustrated in Figure 7). Other embodiments may comprise both instillation and negative-pressure therapy (as shown in Figure 5, for example). Some embodiments may locate the controller 130 in different locations within the system. For example, the controller 130 may be located at the instillation sensor module 160, at one of the pumps 535, at the dressing interface 510, or as a separate unit physically apart from other elements of the system such as a mobile computing device like a laptop or smartphone. In some embodiments, a separate negative-pressure therapy controller may independently operate the negative-pressure source, while a separate instillation controller may independently operate instillation. In some such embodiments, the two controllers may be configured to communicate with each other to allow coordination of negative-pressure therapy and instillation.

[0070] Some embodiments may further comprise a Raman Spectroscopy (RAMAN) (or in some embodiments a Fourier Transform Infrared (FTIR)) sensor 545 disposed in a flowpath between the dressing interface and the negative-pressure source 105 (i.e. the exudate flowpath), and configured to monitor fluid (e.g. exudate) removed from the dressing interface 510 and the tissue site during negative-pressure therapy. In some embodiments, the sensor 545 may provide certain exudate data indicative of such fluid. This sensed exudate data may be analyzed for trace substances in some embodiments, for example to evaluate the health of the tissue site. In some embodiments, the volume of exudate may be compared to the volume of instillation, to ensure proper removal. In some embodiments, sensed exudate data may also be used to ensure that any manually instilled fluids are safe for the patient and/or the device. In some embodiments, the interface for the RAMAN sensor 545 may comprise a fluid barrier (e.g. located between the sensor 545 and the exudate flowpath) configured to allow sensing without significantly impacting sensing capabilities, such as a polyurethane film.

[0071] Figure 6 is a schematic view of an exemplary embodiment of the instillation sensor module 160 for use with the system of Figure 5, illustrating additional details that may be associated with some embodiments. As shown in Figure 6, some embodiments of the instillation sensor module 160 may comprise a plurality of input ports 515; a output port 520; a module flowpath between the input ports 515 and the output port 520; and a detector 525 configured to sense fluid in the module flowpath and generate sensed data. In some embodiments, the detector 525 may comprise an FTIR detector and/or a RAMAN sensor. The FTIR detector may be a micro-spectrometer configured to determine chemical make-up. An example of an FTIR detector may be a SCIO molecular sensor supplied by Consumer Physics. The detector 525 may also be configured to transmit sensed data regarding the fluid (e.g. to the controller 130). In some embodiments, the detector 525 may be located in proximity to the outlet port 520 (e.g. to sense fluid in the module flowpath in proximity to the output port 520).

[0072] In some embodiments, each of the input ports 515 may comprises a one-way valve 605 configured to prevent backflow from the module flowpath. In other embodiments, the one-way valve 605 may be located in the channel conduits instead. Some embodiments of the instillation sensor module 160 may further comprise a buffer 610 located between the detector 525 and the module flowpath, wherein the buffer 610 is configured to shield the detector 525 from direct expose to fluid in the module flowpath without significantly impacting sensing of the fluid. For example, the buffer 610 may comprise a polyurethane or other polymer film. In some embodiments, each input port 515 may comprise a breachable seal 615, which may be configured to prevent fluid flow into or out of the input port 515 unless breached. For example, the breachable seal 615 may comprise a soft polymeric membrane, such as TPE (e.g. Santoprene™), configured to be breached by connection of the corresponding channel conduit. In some embodiments, each channel conduit may comprise a connector end, and each connector end may be configured to breach the breachable seal 615 upon connection and to removably attach the conduit to the input port 515 for fluid communication therebetween.

[0073] In some instillation sensor module 160 embodiments, the module flowpath may comprise a mixing chamber 620. In some embodiments, the mixing chamber 620 may be configured to mix a plurality of different instillation fluids from two or more input ports 515 prior to exiting via the output port 520, to ensure that the output fluid has the proper concentration of each instillation fluid. For example, saline might be used to dilute another instillation fluid to a specified concentration. In some embodiments, two sources of the same instillation fluid may be mixed from two input ports 515 to ensure a substantially uniform concentration of that instillation fluid. In some embodiments, the mixing chamber 620 may comprise a mixing element 625. In some embodiments, the mixing element 625 may employ vortex-based technology, such as a static mixer element configured so that flow of the plurality of fluids over the static mixer element may operate to effectively mix the fluids to a substantially uniform concentration. For example, mixing may be based on turbulent movement of the fluids. In some embodiments, the instillation sensor module 160 may be configured without a holding chamber in which fluid could sit for a substantial amount of time and change concentration. For example, the mixing chamber 620 may be located in proximity to the output port 520 in some embodiments, so that mixed fluids are discharged through the output port 520 shortly after mixing and before the concentration may change. In some embodiments, the detector 525 may be configured to sense fluid between the mixing chamber 620 (e.g. mixing element 625) and the outlet port 520. In some embodiments, the detector 525 may comprise a wireless communication module, in communication with one or more sensors (e.g. an FTIR sensor), that may include a microprocessor and a wireless communication chip powered by a power source. The wireless communication module may be configured to transmit sensed data from the one or more sensors to the controller by wireless means.

[0074] Figure 7 is a schematic view of an alternative embodiment of an instillation system 700, illustrating additional details that may be associated with some embodiments of the therapy system 100 of Figure 1. The embodiment of Figure 7 may be similar to the instillation portion of the system shown in Figure 5, but may use a single pump 535 to operate the plurality of channels 505. For example, the system of Figure 7 may comprises a plurality of channels 505 with a plurality of instillation fluid containers 530, along with a single pump 535 and a selection valve 705 between the pump 535 and the plurality of instillation fluid containers 530. The selection valve 705 may be operable to selectively place the pump 535 in fluid communication with each of the plurality of instillation fluid containers 530, thereby selectively placing each of the fluid containers 530 in fluid communication with the instillation sensor module 160. Some embodiments may further comprise a pump actuator 540 communicatively coupled to the controller 130 and configured to operate the pump 535 responsive to instructions from the controller 130, and a switch actuator 710 communicatively coupled to the controller 130 and configured to operate the selection valve 705 based on instructions from the controller 130. For example, the pump actuator 540 and the switch actuator 710 may each comprise a wireless receiver configured to receive instructions (e.g. an instruction signal) from the controller 130. In the embodiment of Figure 7, the controller 130 may be located on the pump 535. In other embodiments (not shown) the controller 130 may be located elsewhere, such as on the selection valve 705, on the instillation sensor module 160, on the dressing interface 510, or as a separate and distinct element such as a mobile computing device. While shown here as relating only to instillation, in some embodiments the system set-up of Figure 7 may be used in conjunction with a negative-pressure therapy system.

[0075] Figure 8 is a schematic isometric view of an exemplary embodiment of the therapy system 100 of Figure 5, illustrating additional details that may be associated with some embodiments. Figure 8 illustrates an exemplary combined negative-pressure-instillation unit 805. The unit 805 may comprise a negative-pressure source 105 and negative pressure exudate container 115 configured to be in fluid communication with the dressing 110, and thereby the tissue site, as well as a plurality of instillation fluid containers 530 configured to be in fluid communication with the dressing 110. In some embodiments, the unit 805 may also comprise the one or more instillation pumps 535. In Figure 8, the pumps 535, which may be configured to deliver fluid from the plurality of fluid containers 530 to the instillation sensor module 160 and then to the dressing 110, may each be peristaltic pumps. For example, each pump may comprise a peristaltic pump head configured to act on the corresponding channel conduits in order to drive fluid towards the instillation sensor module 160 and the dressing 110.

[0076] In the embodiment of Figure 8, for each of the channels, the fluid container 530 may comprise a bag or bottle, which may be disposable. Some embodiments may further comprise one or more fluid flow sensors 810 configured to detect fluid flow issues with respect to each of the at least one channel. For example, the one or more fluid flow sensors 810 may be configured to detect blockage of flow, engagement of the channel, and/or bubbles in the channel. In some embodiments, the instillation fluid containers 530 may be configured for use with a cartridge 815, which may have a mounting location 820 and the one or more fluid flow sensors 810. In some embodiments, the mounting location 820 may comprise a hook to hang a bag of instillation fluid. In Figure 8, the cartridge 815 may be located on the unit 805. In some embodiments, the one or more cartridge 815 may be removable from the unit 805 and/or disposable. The unit 805 may comprise a display 825 and/or an input device. In some embodiments, the display 825 may be a graphical user interface (GUI) configured to both display and receive input from a user. In some embodiments, the RAMAN sensor may be located in the instillation sensor module 160, although in other embodiments the RAMAN sensor may be located in a separate fluid path between the dressing 110 and the negative-pressure source 105.

[0077] In use, instillation and negative-pressure therapy may be cyclically applied to the tissue site 810. With respect to instillation, the controller 130 may direct delivery (e.g. pumping) of the instillation fluid from one or more channel (e.g. instillation fluid container 530), for example based on the protocol which may be implemented by software running on the controller in some embodiments. The instillation fluid may be sensed by the detector in the instillation sensor module 160, such as the FTIR detector, before delivery to the dressing 110 and/or the tissue site 840. The detector may transmit sensed data regarding the fluid to the controller 130 for analysis. The controller 130 may generate and send instructions to one or more of the channels based on its analysis of the sensed data. Responsive to the instructions, the channels may alter fluid flow. In some embodiments, altering fluid flow may comprise stopping one or more pumps 535, switching between channels, and/or altering the flowrate for one or more channels. In some embodiments, two or more fluids may be mixed, and the concentration may be checked by the detector of the instillation sensor module 160. The appropriate fluids from the channels may be delivered to the dressing and the tissue site 840, for example after verification by the detector.

[0078] The systems, apparatuses, and methods described herein may provide significant advantages. For example, the instillation detector may confirm that the appropriate fluid is being applied at the appropriate time. In some embodiments, a plurality of instillation fluids may be applied to the tissue site based on a prescribed regime (e.g. the protocol), and the detector may assist in ensuring that the appropriate one or more fluids are applied to the tissue site appropriately. The controller may automatically adjust instillation fluid flow based on the sensed data from the detector, in some embodiments, to ensure the proper composition and/or concentration. The ability to switch between different instillation fluids may provide healing improvements to the tissue site, by allowing different fluids with different properties to be used at different stages in treatment. For example, healing may be improved if PRONTOSAN® Irrigation Solution is used first, followed by saline solution. PRONTOSAN® may be prescribed to address infection, and/or saline solution may be prescribed to better promote granulation. And the ability to coordinate negative-pressure therapy and instillation with multiple instillation fluids may further improve wound healing.

[0079] While shown in a few illustrative embodiments, a person having ordinary skill in the art will recognize that the systems, apparatuses, and methods described herein are susceptible to various changes and modifications that fall within the scope of the appended claims. Moreover, descriptions of various alternatives using terms such as “or” do not require mutual exclusivity unless clearly required by the context, and the indefinite articles "a" or "an" do not limit the subject to a single instance unless clearly required by the context. Components may be also be combined or eliminated in various configurations for purposes of sale, manufacture, assembly, or use. For example, in some configurations the dressing 110, the container 115, or both may be eliminated or separated from other components for manufacture or sale. In other example configurations, the controller 130 may also be manufactured, configured, assembled, or sold independently of other components.

[0080] The appended claims set forth novel and inventive aspects of the subject matter described above, but the claims may also encompass additional subject matter not specifically recited in detail. For example, certain features, elements, or aspects may be omitted from the claims if not necessary to distinguish the novel and inventive features from what is already known to a person having ordinary skill in the art. Features, elements, and aspects described in the context of some embodiments may also be omitted, combined, or replaced by alternative features serving the same, equivalent, or similar purpose without departing from the scope of the invention defined by the appended claims.

Claims

CLAIMS What is claimed is:

1. A system for treating a tissue site, comprising: an instillation sensor module comprising: at least one input port; an output port; a flowpath between the at least one input port and the output port; and a detector configured to sense fluid in the flowpath and generate sensed data; at least one channel fluidly coupled to one of the at least one input port, each of the at least one channel comprising a fluid container; a controller communicatively coupled to the detector and the at least one channel; and a negative-pressure therapy unit.

2. The system of claim 1, wherein the detector comprises an FTIR detector.

3. The system of any of claims 1-2, wherein each of the at least one input port comprises a one way valve configured to prevent backflow from the flowpath.

4. The system of any of claims 1-3, wherein the instillation sensor module further comprises a buffer located between the detector and the flowpath, wherein the buffer is configured to shield the detector from direct expose to fluid in the flowpath without significantly impacting sensing of the fluid.

5. The system of any of claims 1-4, wherein the detector is configured to sense chemical composition and/or concentration of the fluid.

6. The system of any of claims 1-5, wherein the flowpath comprises a mixing chamber.

7. The system of any of claims 1-6, further comprising a dressing interface, wherein the output port is in fluid communication with the dressing interface, and the NP therapy unit is in fluid communication with the dressing interface.

8. The system of any of claims 1-7, wherein the at least one channel comprises a plurality of channels, and the at least one input port comprises a plurality of input ports.

9. The system of any of claims 1-8, wherein each of the at least one channel comprises: a pump configured to direct fluid from the fluid container to one of the at least one input port; and an actuator configured to operate the pump.

10. The system of any of claims 1-7, wherein the at least one channel comprises a plurality of channels, the system further comprising a single pump and a selection valve between the pump and the plurality of fluid containers operable to selectively place the pump in fluid communication with each of the plurality of fluid containers.

11. The system of claim 10, further comprising a pump actuator communicatively coupled to the controller and configured to operate the pump responsive to instructions from the controller, and a switch actuator communicatively coupled to the controller and configured to operate the selection valve based on instructions from the controller.

12. The system of any of claims 1-11, wherein, for each of the at least one channel, the pump comprises a peristaltic pump.

13. The system of any of claims 1-12, wherein, for each of the at least one channel, the fluid container comprises a bag or bottle.

14. The system of any of claims 8-13, wherein the fluid container for each of the plurality of channels comprises a different instillation fluid.

15. The system of any of claims 8-14, wherein a first of the plurality of fluid containers comprises a first instillation fluid, and a second of the plurality of fluid containers comprises a second instillation fluid.

16. The system of any of claims 8-15, wherein the controller directs instillation from one or more of the plurality of fluid containers based on a protocol.

17. The system of any of claims 8-15, wherein the controller comprises a pre-defined protocol, and the protocol directs sequential pumping of instillation fluid from the plurality of channels.

18. The system of any of claims 8-15, wherein the controller comprises a pre-defined protocol, and the protocol directs simultaneous pumping of instillation fluid from the plurality of channels for mixing within the flowpath.

19. The system of any of claims 1-18, wherein the controller comprises a wireless transceiver configured to receive sensed data from the detector and to transmit instructions to the pump based on the sensed data and/or the protocol.

20. The system of any of claims 1-19, wherein the controller is configured to compare the sensed data to a look-up table to determine the chemical composition of the fluid in the flowpath.

21. The system of any of claims 1-20, wherein the controller is configured to determine concentration of fluids in the flowpath based on sensed data.

22. The system of any of claims 8-15 and 19-21, wherein the controller comprises a pre-defmed protocol, and the controller directs fluid delivery from one or more of the channels based on the sensed data and/or the protocol.

23. The system of any of claims 8-15 and 19-21, wherein the controller comprises a pre-defmed protocol configured to activate an alert if the sensed data chemical composition does not match the protocol.

24. The system of any of claims 9-15 and 19-21, wherein the controller comprises a pre-defmed protocol, and the protocol directs the pump for one or more of the at least one channel to stop if the sensed data chemical composition does not match the protocol.

25. The system of any of claims 9-15 and 19-21, wherein the controller comprises a pre-defmed protocol, and the protocol directs the pump for one or more of the at least one channel to alter flowrate if the sensed data concentration does not match the protocol.

26. The system of any of claims 1-25, wherein the controller determines the identity of the fluids in each channel based on sensed data from the detector.

27. The system of any of claims 1-26, further comprising one or more fluid flow sensors configured to detect fluid flow issues with respect to each of the at least one channel.

28. The system of claim 27, wherein the one or more fluid flow sensors are configured to detect blockage of flow, engagement of the channel, and/or bubbles in the channel.

29. The system of any of claims 27-28, wherein the container is configured for use with a cartridge having a mounting location and the one or more fluid flow sensors.

30. The system of any of claims 1-29, wherein the negative-pressure therapy unit comprises a negative-pressure source.

31. The system of any of claims 1-30, wherein the negative -pressure therapy unit comprises the controller, and the controller is configured to operate both instillation and negative-pressure therapy.

32. The system of any of claims 7-31, further comprising a RAMAN sensor configured to monitor fluid removed from the dressing interface during negative-pressure therapy.

33. The system of claim 32, wherein the RAMAN sensor is located in the instillation sensor module.

34. An instillation sensor module, comprising: at least one input port; an output port; a flowpath between the at least one input port and the output port; and a detector configured to sense fluid in the flowpath and generate sensed data.

35. The module of claim 34, wherein the detector comprises an FTIR detector.

36. The module of any of claims 34-35, wherein the at least one input port comprises a plurality of input ports, each configured to receive fluid from a channel.

37. The module of any of claims 34-36, wherein each of the at least one input port comprises a one-way valve configured to prevent backflow from the flowpath.

38. The module of any of claims 34-37, wherein the detector is communicatively coupled to a controller and is configured to transmit sensed date to the controller.

39. The module of any of claims 34-38, further comprising a buffer located between the detector and the flowpath, wherein the buffer is configured to shield the detector from direct expose to fluid in the flowpath without significantly impacting sensing of the fluid.

40. The module of any of claims 34-39, wherein the detector is configured to sense chemical composition and/or concentration.

41. The module of any of claims 34-40, wherein each of the at least one input port comprises a breachable seal.

42. The module of any of claims 34-41, wherein the flowpath comprises a mixing chamber configured to mix two or more fluids simultaneously flowing into the manifold through two or more of the plurality of input ports.

43. A system for instillation of a tissue site, comprising: an instillation sensor module comprising: at least one input port; an output port; a flowpath between the at least one input port and the output port; and a detector configured to sense fluid in the flowpath and generate sensed data; at least one channel fluidly coupled to one of the at least one input port, each of the at least one channel comprising a fluid container; and a controller communicatively coupled to the detector and the at least one channel.

44. The system of claim 43, wherein the detector comprises an FTIR detector.

45. The system of any of claims 43-44, wherein each of the at least one channel comprises: a pump configured to direct fluid from the fluid container to the input port; and an actuator configured to operate the pump.

46. The system of any of claims 43-45, wherein each of the at least one input port comprises a breachable seal, each of the at least one channel comprises a conduit, each conduit comprises a connector end, and each connector end is configured to breach the breachable seal upon connection and to removably attach the conduit to the input port for fluid communication therebetween.

47. The system of any of claims 43-46, wherein the pump comprises a peristaltic pump.

48. The system of any of claims 43-47, wherein the fluid container comprises a bag or bottle.

49. The system of any of claims 43-48, wherein the at least one channel comprises a plurality of channels.

50. The system of claim 49, wherein the at least one input port comprises a plurality of input ports.

51. The system of any of claims 43-48, wherein the at least one channel comprises a plurality of channels, the system further comprising a single pump and a selection valve between the pump and the plurality of fluid containers operable to selectively place the pump in fluid communication with each of the plurality of fluid containers.

52. The system of claim 51, further comprising a pump actuator communicatively coupled to the controller and configured to operate the pump responsive to instructions from the controller, and a switch actuator communicatively coupled to the controller and configured to operate the selection valve based on instructions from the controller.

53. The system of any of claims 43-52, further comprising a dressing interface in fluid communication with the output port.

54. The system of any of claims 49-53, wherein the fluid container for each of the plurality of channels comprises a different instillation fluid.

55. The system of any of claims 49-54, wherein a first of the plurality of fluid containers comprises a first instillation fluid, and a second of the plurality of fluid containers comprises a second instillation fluid.

56. The system of any of claims 54-55, wherein the controller directs instillation from one or more of the plurality of fluid containers based on a protocol.

57. The system of any of claims 54-55, wherein the controller comprises a pre-defined protocol, and the protocol directs sequential pumping of instillation fluid from the plurality of channels.

58. The system of any of claims 54-55, wherein the controller comprises a pre-defined protocol, and the protocol directs simultaneous pumping of instillation fluid from two or more of the plurality of channels.

59. The system of 54-55, wherein the controller comprises a pre-defined protocol, and the protocol directs fluid delivery from one or more of the channels based on the sensed data and/or the protocol.

60. The system of any of claims 54-55, wherein the controller comprises a pre-defmed protocol, and the protocol activates an alert if the sensed data chemical composition does not match the protocol.

61. The system of any of claims 54-55, wherein the controller comprises a pre-defmed protocol, and the protocol directs the pump for one or more of the at least one channel to stop if the sensed data chemical composition does not match the protocol.

62. The system of any of claims 54-55, wherein the controller comprises a pre-defmed protocol, and the protocol directs the pump for one or more of the at least one channel to alter flowrate if the sensed data concentration does not match the protocol.

63. The system of any of claims 43-62, wherein the controller determines the identity of the fluids in each channel based on sensed data from the detector.

64. The system of any of claims 45-63, wherein the controller comprises a wireless transceiver configured to receive sensed data from the detector and to transmit instructions to the pump based on the sensed data and/or the protocol.

65. The system of any of claims 43-64, further comprising one or more fluid flow sensors configured to detect fluid flow issues with respect to the container.

66. The system of claim 65, wherein the container is configured for use with a cartridge having a mounting location and the one or more fluid flow sensors.

67. The systems, apparatuses, and methods substantially as described herein.