Patent Description:
While the clinical benefits of negative-pressure therapy are widely known, improvements to therapy systems, components, and processes may benefit healthcare providers and patients. <CIT> discloses a negative pressure treatment system with an ultrasound transducer mounted under the wound cover. <CIT> discloses a negative pressure treatment system with a device to general low-amplitude vibrations in the fluid conductors to reduce blockages. <CIT> discloses a device for manipulating the circulation of a patient including a vibration inducing element,
<CIT> discloses a fluid extraction chamber for applying negative pressure to a patient.

The invention is defined by the appended claims in which there is required a system for delivering negative pressure and vibrations proximate a wound site, comprising: a dressing adapted to be fluidly coupled to the wound site and further adapted to translate vibrations to the wound site; a pad having a pressure port adapted to be coupled to a source of negative pressure and to be fluidly coupled to the dressing, and further having a vibration frame having an opening adapted to be fluidly coupled to the wound site; a drape adapted to cover the dressing and the pad to form a seal between the wound site and the environment, the drape having an opening exposing the vibration frame to the environment; and a vibration module supported by the vibration frame and adapted to be fluidly coupled to the dressing for providing the vibrations, wherein the vibration module comprises: a carrier mounted within the vibration frame and having cylindrical walls closed at one end by a base and an opening opposite the base and concentric with the opening of the vibration frame, the base having a raised port extending into the carrier, and the cylindrical walls having a leak conduit adapted to allow a predetermined leak into the carrier; a diaphragm sealing the opening of the carrier and being axially aligned with the raised port and configured to move axially toward the base in response to the application of negative pressure in the carrier; and a biasing element disposed within the carrier between the diaphragm and the base, the biasing element being biased to move the diaphragm away from the base when negative pressure is removed from the carrier.

A selection of optional features is set out in the dependent claims.

<FIG> is a simplified functional block diagram of an example embodiment of a therapy system <NUM> that can provide negative-pressure therapy 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 burns, 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 a 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 <NUM> 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 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 other components into a therapy unit.

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 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 <NUM> 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 capralactones. 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 Expopack Advanced Coatings, 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 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.

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.

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>.

Referring now to <FIG> in combination, an elevated perspective view of a vibration delivery system <NUM> illustrating additional details that may be associated with some example embodiments of the therapy system <NUM> and an exploded view of the vibration delivery system <NUM> are shown respectively. The vibration delivery system <NUM> may include a pad <NUM> configured for placement over a wound site. A drape ring <NUM> surrounds the periphery of the pad <NUM>, and has an adherent on the wound-facing side to effectively seal the wound site from the outside environment. In certain embodiments, the drape ring <NUM> may adhere to a drape (not shown) that encloses the wound and adheres to the periwound area. The vibration delivery system <NUM> may further include a pressure port <NUM> coupled to the pad <NUM> for communicating pressure through the pad <NUM> to the wound. In some embodiments, a fluid conductor such as a delivery tube <NUM> connects to the pressure port <NUM> and to a negative pressure source (not shown) such as the negative-pressure source <NUM> for delivering negative pressure to the wound site. A vibration module <NUM> connects to a vibration frame <NUM>, which in turn is coupled to the pad <NUM>.

The drape ring <NUM> defines an opening <NUM> therein. The opening <NUM> is shaped to connect with the periphery of the pad <NUM>. Preferably the drape ring <NUM> comprises an elastomeric material, and is conformable for placement on irregular surfaces. The drape ring <NUM> couples to a drape (not shown) such as the cover <NUM> and secures the vibration delivery system <NUM> to the drape. The pad <NUM> includes the vibration frame <NUM>, which may be shaped to receive the vibration module <NUM> therein. The pad <NUM> defines an opening <NUM> for fluid communication between the vibration frame <NUM> and the wound site, and includes a port <NUM> adapted to receive a leak tube <NUM> of the vibration module <NUM>.

Referring now to <FIG>, an exploded view of the vibration module <NUM> is shown. The vibration module <NUM> may comprise a carrier <NUM> adapted to be disposed within the vibration frame <NUM> above the opening <NUM>. The carrier <NUM> may comprise generally cylindrical walls <NUM> closed at one end by a base <NUM> forming a chamber within the carrier <NUM> and an opening <NUM> opposite the base <NUM>. In some embodiments, the opening <NUM> of the carrier <NUM> may be concentric with the opening <NUM> of the vibration frame <NUM>. The carrier <NUM> may further comprise a raised port <NUM> extending from the base <NUM> within the chamber of the carrier <NUM> towards the opening <NUM>. In some embodiments, the raised port <NUM> may be adapted to be fluidly coupled to the chamber of the carrier <NUM> for delivering pressure and mechanical force to the vibration frame <NUM> and the underlying tissue interface <NUM>. The carrier <NUM> may further comprise a leak conduit <NUM> fluidly coupled to the chamber of the carrier <NUM> and may contain a filter <NUM> adapted to regulate the amount of fluid leakage (FL) into the chamber of the carrier <NUM>. The filter <NUM> may be adjustable, such that FL into the chamber of the carrier <NUM> may be controlled or sealed. In some embodiments, multiple filters <NUM> may be utilized to increase the leak rate of air into the carrier <NUM>. The filter <NUM> may contain suitable material, such as for example a high density porous foam material, or a low density porous foam material, to control the leak rate as desired. The filter <NUM> may also be adapted to be closed to the environment through the inclusion of a valve (not shown).

The vibration module <NUM> may further comprise a diaphragm <NUM> having a center portion <NUM> and a peripheral portion <NUM> that seals or closes the opening <NUM> of the carrier <NUM>. In some embodiments, the peripheral portion <NUM> may be flexibly coupled to the upper portion of the generally cylindrical walls <NUM> of the carrier <NUM> so that the entire diaphragm <NUM> is flexibly mounted with respect to the distance from the base <NUM>. In yet other embodiments, the peripheral portion <NUM> may be rigidly mounted to the upper portion of the generally cylindrical walls <NUM> and flexibly coupled to the center portion <NUM> so that the entire diaphragm <NUM> is flexibly mounted with respect to the distance from the base <NUM>. In some embodiments, the center portion <NUM> may be axially aligned with the raised port <NUM> and configured to move axially toward the base <NUM> in response to the application of negative pressure into the chamber of the carrier <NUM>. In still other embodiments, the diaphragm may comprise a rolling diaphragm.

The vibration module <NUM> may further comprise a biasing element such as, for example, a coil spring <NUM> disposed within the chamber of the carrier <NUM> between the center portion <NUM> of the diaphragm <NUM> and the base <NUM> of the carrier <NUM>. In some embodiments, the coil spring <NUM> additionally may encircle the raised port <NUM> while resting on the base <NUM> of the carrier <NUM>. In yet other embodiments, the coil spring <NUM> may be a coil spring configured to bias the diaphragm <NUM> away from the base <NUM> when negative pressure is removed from the chamber of the carrier <NUM> in a "relaxed state" and further configured to be compressed by the diaphragm <NUM> when negative pressure is applied to the chamber of the carrier <NUM> in a "compressed state" as described further below. In some embodiments, the coil spring <NUM> may have a spring constant such that the coil spring <NUM> may be compressed a compressed distance (d1) toward the base <NUM> in response to the amount of negative pressure applied to the chamber of the carrier <NUM> while in the compressed state. In yet other embodiments, the coil spring <NUM> may have a spring constant that may be adjustable to vary the compressed distance (d1) in response to the negative pressure applied to the chamber of the carrier <NUM>. In some example embodiments, the vibration module <NUM> may further comprise an adjustment mass <NUM> that may be disposed or positioned on the center portion <NUM> of the diaphragm <NUM> and operatively coupled to the coil spring <NUM> to vary the compressed distance (d1) of the diaphragm <NUM> in response to the application of negative pressure to the chamber of the carrier <NUM>. The weight of the adjustment mass <NUM> may be selected to supplement the spring constant of the coil spring <NUM> to achieve a desired compressed distance (d1) of the diaphragm <NUM> in response to the application of negative pressure to the chamber of the carrier <NUM>. The diaphragm <NUM> may further comprise a mass receptacle <NUM> disposed on the center portion <NUM> of the diaphragm <NUM> receiving the adjustment mass <NUM> and to hold the adjustment mass <NUM> in place during operation between the relaxed state and the compressed state. In some example embodiments, the vibration module <NUM> may further comprise a cover <NUM> that may be disposed over the adjustment mass <NUM> on the peripheral portion <NUM>. In some embodiments, the cover <NUM> may be removable so that the adjustment mass <NUM> may be selected to achieve a desired compressed distance (d1) of the diaphragm <NUM>. In some other embodiments, the cover <NUM> may comprise apertures such as, for example, openings <NUM> for coupling the space between the diaphragm <NUM> and the cover <NUM> to the environment. In some embodiments, the openings <NUM> may relieve pressure variations in the space under the cover <NUM> that may result from pressure differentials created by the diaphragm <NUM> when moving between the relaxed state and the compressed state in response to the application and removal of negative pressure from the chamber of the carrier <NUM>.

In some embodiments, the adjustment mass <NUM> may be used to increase the kinetic energy of the diaphragm <NUM> as it contacts the raised port <NUM>. When negative pressure is applied to the chamber of the carrier <NUM>, the diaphragm <NUM> compresses the coil spring <NUM> as described above. The FL is adjustable such that the FL into the chamber of the carrier <NUM> causes the diaphragm <NUM> to slightly decompress and move away from the raised port <NUM>, but the ongoing negative pressure recompresses the diaphragm <NUM> against the raised port <NUM>. The ongoing intermittent contact of the diaphragm <NUM> and the raised port <NUM> generates a vibration. The application of the adjustment mass <NUM> to the diaphragm <NUM> may be used to increase or decrease the force between the diaphragm <NUM> and the raised port <NUM>, and will correspondingly increase or decrease the vibration frequency and amplitude.

Referring now to <FIG> in combination, a cross-sectional view of the vibration module <NUM> of <FIG> is shown in a "relaxed state" and in a "compressed state," respectively. When the negative-pressure source <NUM> is activated, air from within the chamber of the carrier <NUM> is pulled through the raised port <NUM> and through the opening <NUM> into the wound site. At the same time, air enters the carrier <NUM> through the leak conduit <NUM> and the filter <NUM> in an attempt to equalize the pressure. Because the filter <NUM> slows the amount of air that can be introduced from the environment into the carrier <NUM>, the coil spring <NUM> compresses, ultimately until the diaphragm <NUM> contacts the raised port <NUM>. The impact of the diaphragm <NUM> having the adjustment mass <NUM> disposed thereon against the raised port <NUM> generates a mechanical force between the diaphragm <NUM> and the raised port <NUM>.

In <FIG>, the coil spring <NUM> is in the "compressed state," such that the diaphragm <NUM> abuts the raised port <NUM>. The leak rate of the leak conduit <NUM> can be set to prevent state system pressure equalization between the chamber of the carrier <NUM> and the environment, such as by increasing the pore size of the filter <NUM>, increasing or decreasing the adjustable mass <NUM>, varying the amount of negative pressure or selecting a different spring constant for the coil spring <NUM>. Because of the varying pressure in the chamber of the carrier <NUM>, the diaphragm <NUM> continuously vibrates against the raised port <NUM> as it tries to reach equilibrium, and generates mechanical force, which may be translated to the dressing <NUM> and the wound site. When the negative-pressure source <NUM> is deactivated and negative pressure is removed from the chamber of the carrier <NUM>, allowing the chamber and the environment to equalize, the coil spring <NUM> expands and pushes the diaphragm <NUM> away from the raised port <NUM>, thus returning to the "relaxed state" shown in <FIG>.

The vibration force resulting from the transfer of kinetic energy from the vibration module <NUM> and pad <NUM> to the dressing <NUM> and wound site has beneficial properties. The vibration force functions to relieve any blockages in the dressing <NUM> or fluid conductor such as the delivery tube <NUM>, thereby improving exudate flow through the pressure port <NUM> and the delivery tube <NUM> or clearing blockages that may occur in the dressing <NUM>. Such blockages may be caused by debris, fluid coagulation or biofilm formation and combinations thereof. The vibration force may also be set sufficient enough to create enough energy to actively debride the wound, as the vibration force may cause the dressing <NUM> to vibrate, which in turn if the force is great enough, translate from the dressing <NUM> to the wound site. The resultant vibration at the wound site, if strong enough, may actively debride the tissue.

Referring now to <FIG>, an elevated perspective view of a vibration delivery system <NUM> illustrating additional details that may be associated with some example embodiments of the therapy system <NUM> and the vibration delivery system <NUM>. The vibration delivery system <NUM> may include the pad <NUM> configured for placement over a wound site. The drape ring <NUM> surrounds the periphery of the pad <NUM>, and may have an adherent on the wound-facing side to effectively seal the wound site from the outside environment. In certain embodiments, the drape ring <NUM> may adhere to a drape (not shown) that encloses the wound and adheres to the periwound area. The vibration delivery system <NUM> may further include a pressure port <NUM> coupled to the pad <NUM> for communicating pressure through the pad <NUM> to the wound. In some embodiments, a fluid conductor such as a delivery tube (not shown) connects to the pressure port <NUM> and to a negative-pressure source (not shown) such as the negative-pressure source <NUM> for delivering negative pressure to the wound site. A vibration module <NUM> connects to a vibration frame <NUM>, which in turn is coupled to the pad <NUM>. The vibration frame <NUM> has an opening <NUM> adapted to be fluidly coupled to the wound site.

The vibration module <NUM> may comprise a carrier <NUM> adapted to be disposed within the opening <NUM> of the vibration frame <NUM>. The carrier <NUM> may comprise generally cylindrical walls <NUM> closed at one end by a base <NUM> forming a chamber within the carrier <NUM> and an opening <NUM> opposite the base <NUM>. In some embodiments, the opening <NUM> of the carrier <NUM> may be concentric with the opening <NUM> of the vibration frame <NUM>. The carrier <NUM> may further comprise a raised port <NUM> extending from the base <NUM> within the chamber of the carrier <NUM> towards the opening <NUM>. In some embodiments, the raised port <NUM> may be adapted to be fluidly coupled to the chamber of the carrier <NUM> for delivering pressure and mechanical force to the vibration frame <NUM> and the underlying tissue interface <NUM>.

Referring now to <FIG> and <FIG> in combination, the vibration module <NUM> may further comprise a diaphragm <NUM> having a center portion <NUM> and a peripheral portion <NUM> that seals or closes the opening <NUM> of the carrier <NUM>. In some embodiments, the peripheral portion <NUM> may be flexibly coupled to the upper portion of the generally cylindrical walls <NUM> of the carrier <NUM> so that the entire diaphragm <NUM> is flexibly mounted with respect to the distance from the base <NUM>. In yet other embodiments, the peripheral portion <NUM> may be rigidly mounted to the upper portion of the generally cylindrical walls <NUM> and flexibly coupled to the center portion <NUM> so that the entire diaphragm <NUM> is flexibly mounted with respect to the distance from the base <NUM>. In some embodiments, the center portion <NUM> may be axially aligned with the raised port <NUM> and configured to move axially toward the base <NUM> in response to the application of negative pressure into the chamber of the carrier <NUM>.

In certain embodiments, the chamber of the carrier <NUM> may be adapted to receive a bearing <NUM>, which is adapted to rotate within and substantially fill the chamber of the carrier <NUM>. The bearing <NUM> may be adapted to define a mass opening <NUM> adapted to receive an eccentric mass <NUM> therein and to couple the bearing <NUM> to the eccentric mass <NUM>. The bearing <NUM> further comprises a concentric opening <NUM> adapted to receive the raised port <NUM> therethrough.

A linkage <NUM> having an axial opening <NUM> and a mass coupling portion <NUM> engages the bearing <NUM> by the eccentric mass <NUM>, which is received by the mass coupling portion <NUM>. The axial opening <NUM> of the linkage <NUM> may be adapted to couple with a plunger <NUM> having a top portion <NUM> and a shaft <NUM> descending from the top portion <NUM>. The shaft <NUM> may be adapted to engage the linkage <NUM> in a rotational relationship, such that when the plunger <NUM> moves through the axial opening <NUM>, the linkage <NUM> and bearing <NUM> correspondingly rotate. Threads <NUM> may be incorporated on the shaft <NUM> to engage the linkage <NUM>. In some embodiments the diaphragm <NUM> encloses the plunger <NUM>, linkage <NUM> and bearing <NUM> within the chamber of the carrier <NUM>.

Referring now to <FIG>, an exploded view of the vibration module <NUM> is shown. In some example embodiments, the vibration module <NUM> may further comprise an adjustment mass <NUM> that may be disposed or positioned on the center portion <NUM> of the diaphragm <NUM> and operatively coupled to the plunger <NUM>. In certain embodiments the plunger <NUM> may be statically affixed to the diaphragm <NUM>. The weight of the adjustment mass <NUM> may be selected to move the increase or decrease the amount of force on the plunger <NUM> and increase or decrease rotation of the linkage <NUM>. The diaphragm <NUM> may further comprise a mass receptacle <NUM> disposed on the center portion <NUM> of the diaphragm <NUM> receiving the adjustment mass <NUM> and to hold the adjustment mass <NUM> in place during operation. In some example embodiments, the vibration module <NUM> may further comprise a cover <NUM> that may be disposed over the adjustment mass <NUM> on the peripheral portion <NUM>. In some embodiments, the cover <NUM> may be removable so that the adjustment mass <NUM> may be selected to achieve a desired force on the plunger <NUM>. In some other embodiments, the cover <NUM> may comprise apertures such as, for example, opening <NUM> for coupling the space between the diaphragm <NUM> and the cover <NUM> to the environment. In some embodiments, the opening <NUM> may relieve pressure variations in the space under the cover <NUM> that may result from pressure differentials created by the diaphragm <NUM> when moving between the relaxed state and the compressed state in response to the application and removal of negative pressure from the chamber of the carrier <NUM>.

Referring now to <FIG> in combination, in certain embodiments, the diaphragm <NUM> may comprise a rolling diaphragm, thereby acting as a biasing element. In such embodiments, the diaphragm <NUM> may be configured to bias the diaphragm <NUM> away from the base <NUM> when negative pressure is removed from the chamber of the carrier <NUM> in a "relaxed state" as shown in <FIG>. When negative pressure is applied to the chamber of the carrier <NUM>, the diaphragm rolls towards the base <NUM> in a "compressed state," and applies force against the plunger <NUM> as shown in <FIG>. When the diaphragm <NUM> is in the compressed state, it effectively is primed, such that when negative pressure is removed from the chamber of the carrier <NUM>, the diaphragm <NUM> ascends within the chamber to the relaxed state. The threads <NUM> engage the linkage <NUM> and rotate the linkage <NUM>, which in turn rotates the bearing <NUM> having the eccentric mass <NUM> thereon. The rotation of the eccentric mass <NUM> about the plunger <NUM> generates a low amplitude high frequency force, which may be translated from the carrier <NUM> to the pad <NUM> and the dressing <NUM>. In some embodiments, the force may be transmitted to the wound site.

Referring now to <FIG>, a graph of pressure versus time is shown for operation of an exemplary embodiment of the vibration delivery system <NUM>. The graph displays a dynamic pressure mode wave as described above with respect to <FIG>. In operation, the vibration module <NUM> begins to vibrate as pressure increases from 25mmHg to 125mmHg at point A, though the pressure targets may be modified as desired. At 125mmHg, the vibration module <NUM> is adapted to be fully primed, indicated as point B. As the pressure decreases to 25mgHg, the vibration delivery module <NUM> continues to vibrate until pressure equilibrium is reached between the vibration delivery module <NUM> and the wound site, indicated by point C.

The systems, apparatuses, and methods described herein may provide significant advantages. For example, certain embodiments allow for debridement of the wound site depending on the kinetic force of the vibration. The translation of the kinetic force to the dressing <NUM> may allow the dressing <NUM> to vibrate against the wound site and debride the wound site. Other exemplary embodiments provide better wound exudate flow through the dressing <NUM> to the negative-pressure source <NUM>, by loosening or removing blockages that may form at locations along the fluid flow pathway from the wound site to the negative-pressure source <NUM>. Such systems, apparatuses and methods described herein may be assisted through the inclusion of a solution source for instillation. Solutions may be selected to help with exudate flow, blockage handling, and debridement.

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 <NUM>, the container <NUM>, or both may be eliminated or separated from other components for manufacture or sale. In other example configurations, the controller <NUM> may also be manufactured, configured, assembled, or sold independently of other components.

Claim 1:
A system for delivering negative pressure and vibrations proximate a wound site, comprising:
a dressing (<NUM>) adapted to be fluidly coupled to the wound site and further adapted to translate vibrations to the wound site;
a pad (<NUM>) having a pressure port (<NUM>) adapted to be coupled to a source of negative pressure (<NUM>) and to be fluidly coupled to the dressing (<NUM>), and further having a vibration frame (<NUM>, <NUM>) having an opening (<NUM>) adapted to be fluidly coupled to the wound site;
a drape (<NUM>) adapted to cover the dressing and the pad (<NUM>) to form a seal between the wound site and the environment, the drape (<NUM>) having an opening (<NUM>) exposing the vibration frame (<NUM>, <NUM>) to the environment; and
a vibration module (<NUM>) supported by the vibration frame (<NUM>, <NUM>) and adapted to be fluidly coupled to the dressing (<NUM>) for providing the vibrations,
characterised in that the vibration module (<NUM>) comprises:
a carrier (<NUM>, <NUM>) mounted within the vibration frame (<NUM>, <NUM>) and having cylindrical walls (<NUM>) closed at one end by a base (<NUM>, <NUM>) and an opening opposite the base (<NUM>, <NUM>) and concentric with the opening of the vibration frame (<NUM>, <NUM>), the base (<NUM>, <NUM>) having a raised port (<NUM>, <NUM>) extending into the carrier (<NUM>, <NUM>), and the cylindrical walls (<NUM>) having a leak conduit (<NUM>) adapted to allow a predetermined leak into the carrier (<NUM>, <NUM>);
a diaphragm (<NUM>, <NUM>) sealing the opening of the carrier (<NUM>, <NUM>) and being axially aligned with the raised port (<NUM>, <NUM>) and configured to move axially toward the base (<NUM>, <NUM>) in response to the application of negative pressure in the carrier (<NUM>, <NUM>); and
a biasing element (<NUM>) disposed within the carrier (<NUM>, <NUM>) between the diaphragm (<NUM>, <NUM>) and the base (<NUM>, <NUM>), the biasing element (<NUM>) being biased to move the diaphragm (<NUM>, <NUM>) away from the base when negative pressure is removed from the carrier (<NUM>, <NUM>).