The invention set forth in the appended claims relates generally to tissue treatment systems and more particularly, but without limitation, to negative-pressure therapy with a manually-actuated piston and a push-to-release actuator.
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.
While the clinical benefits of negative-pressure therapy are widely known, improvements to therapy systems, components, and processes may benefit healthcare providers and patients.
New and useful systems, apparatuses, and methods for providing negative-pressure therapy 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.
For example, in some embodiments, an apparatus for providing negative-pressure therapy may comprise a housing and a barrier disposed in the housing. The barrier may be a reciprocating piston or flexible diaphragm in some embodiments. The barrier may divide the housing into two chambers, and movement of the barrier within the housing can vary the volume of each of the chambers accordingly. The barrier can also provide a fluid seal between the two chambers in some embodiments. A negative-pressure port may be fluidly coupled to one of the chambers, and movement of the barrier to expand the volume of the chamber can reduce the pressure of fluid in the chamber. Movement of the barrier may be effectuated manually in some embodiments. For example, one or more elastic elements may be operatively coupled to the barrier so that movement of the barrier to reduce the volume of the chamber fluidly coupled to the negative-pressure outlet also extends the elastic elements from a neutral state, thereby causing a restoring force to be applied to the barrier. A force contrary to the elastic force may be applied to the barrier by an actuator in some embodiments. For example, the actuator may be a key that can be inserted through an appropriate keyway in the housing to engage the barrier and move the barrier to prime (or charge) the apparatus for negative-pressure therapy. The actuator may also be used to lock the barrier in the primed position in some embodiments. Pressing on the actuator again can release the barrier to activate the apparatus for therapy.
In some embodiments, the housing may comprise an ellipsoidal cylinder, and the barrier may be a sliding seal concentrically disposed therein. The chambers have a variable effective volume defined by the distance between the position of the seal and an opposing end of the chamber. The seal may be connected to one or more elastic elements, such as a spring, which may be used to bias the seal towards increasing the volume of one of the chambers. The springs may have any of a variety of configurations, including ribbon springs. The ribbon spring may be a substantially constant-force spring or a variable-force spring. In some examples, a combination of spring types may be used. In still other examples, a single ribbon may be configured with a coil at each end and attached to a slidable seal at a middle region of the single ribbon. The force exerted on the seal may vary, but a spring force of less than 20 pounds may be suitable for some applications. In some embodiments, the spring force may be less than 0.5 pounds.
More generally, example embodiments of an apparatus for priming a therapy unit are described. The apparatus may be an actuator comprising a shaft, a latch, and a spring biasing the latch toward the shaft. The shaft may further comprise a proximal end and a distal end, and the distal end may be configured for insertion through an opening in a housing of the therapy unit to engage a movable barrier, such as a piston. The latch is generally configured for releasably coupling to a keeper disposed in the housing, and the latch may comprise an opening toward the proximal end of the shaft. In some embodiments, the shaft may be a beam, and the spring may be flat spring or a cantilever spring. For example, in some embodiments, the spring may be a flat spring or a cantilever spring disposed within a plane of the shaft. Additionally, a centralizer may be configured to bias the latch or the spring toward the shaft. The centralizer may comprise a bow in some embodiments. In more particular example embodiments, the shaft may comprise an aperture, and the spring may be a cantilever spring coupled to the shaft and disposed within the aperture.
Additionally or alternatively, example embodiments of an apparatus for releasably retaining a priming apparatus, such as an actuator. In some embodiments, the apparatus may comprise a receptacle, and the receptacle may comprising a wall defining a first aperture and a second aperture. The first aperture may be configured for receiving a distal end of the actuator and the second aperture may be disposed opposite the first aperture and aligned for passage of the distal end of the actuator. A keeper may disposed within the receptacle between the first aperture and the second aperture. In some embodiments, the keeper may comprise a base protruding from the wall, and a ledge extending from the base toward the second aperture.
Systems for providing negative-pressure therapy are also described herein, wherein some example embodiments include a housing having a keyway or other opening for receiving a priming key or other actuator. A piston or other barrier may be reciprocably disposed within the housing and dividing the housing into a proximal chamber and a distal chamber. A negative-pressure port may be fluidly coupled to the distal chamber. In some embodiments, an elastic element, such as a piston spring, may be coupled to the piston for expanding the distal chamber. A keeper may be disposed in the housing between the piston and the keyway. The system may additional comprise a key for moving the piston against the piston spring to a charged position. Some embodiments of the key may comprise a shaft, a latch, and another elastic element, such as a priming spring. The shaft may comprise an engagement end for passage through the keyway and pushing against the piston. The priming spring may couple the latch to the shaft for biasing the latch toward a release position. The system may additionally include a lever operable to move the latch to a lock position in opposition to the priming spring, so that the latch engages the keeper if the piston is released from the charged position while the latch is in the lock position and the latch disengages the keeper if the piston is released from the charged position while the latch is in the release position.
The system may additional include a bump disposed in the housing between the keeper and the keyway in some embodiments. A centralizer pocket may also be disposed in the housing between the bump and the keyway, and a centralizer may be coupled to the lever. The centralizer may be configured to rest in the centralizer pocket if the latch is in the lock position, and may be further configured to engage the bump if the piston is released from the charged position while the latch is in the release position.
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.
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 may omit certain details already well-known in the art. The following detailed description is, therefore, to be taken as illustrative and not limiting.
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.
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 100 may include negative-pressure supply, and may include or be configured to be coupled to a distribution component, such as a dressing. In general, a distribution component may refer to any complementary or ancillary component configured to be fluidly coupled to a negative-pressure supply in a fluid path between a negative-pressure supply and a tissue site. A distribution component is preferably detachable, and may be disposable, reusable, or recyclable. For example, a dressing 102 may be fluidly coupled to a negative-pressure source 104, as illustrated in
In some embodiments, a dressing interface may facilitate coupling the negative-pressure source 104 to the dressing 102. For example, such a dressing interface may be a T.R.A.C.® Pad or Sensa T.R.A.C.® Pad available from KCI of San Antonio, Tex. The therapy system 100 may optionally include a fluid container, such as a container 112, coupled to the dressing 102 and to the negative-pressure source 104.
Additionally, the therapy system 100 may include sensors to measure operating parameters and provide feedback signals indicative of the operating parameters. For example, the therapy system 100 may include a pressure sensor, an electric sensor, or both, coupled to a controller. The pressure sensor may also be coupled or configured to be coupled to a distribution component and to the negative-pressure source 104.
Components may be fluidly coupled to each other to provide a path for transferring fluids (i.e., liquid and/or gas) between the components. For example, components such as the dressing 102 and the negative-pressure source 104 may be fluidly coupled through a fluid conductor, such as a tube. A “tube,” as used herein, broadly includes a tube, pipe, hose, conduit, or other structure with one or more lumina 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. 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. Moreover, some fluid conductors may be molded into or otherwise integrally combined with other components. Coupling may also include mechanical, thermal, electrical, or chemical coupling (such as a chemical bond) in some contexts. For example, a tube may mechanically and fluidly couple the dressing 102 to the container 112 in some embodiments.
In general, components of the therapy system 100 may be coupled directly or indirectly. For example, the negative-pressure source 104 may be directly coupled to the controller 110, and may be indirectly coupled to the dressing 102 through the container 112.
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 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, exudates and other fluids 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” 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 provided by the dressing 102. 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. Similarly, 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 applied to a tissue site 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 −75 mm Hg (−9.9 kPa) and −300 mm Hg (−39.9 kPa).
A negative-pressure supply, such as the negative-pressure source 104, may be an apparatus that can reduce the pressure in a sealed volume, such as a vacuum pump or a suction pump, having an actuator 114. A negative-pressure supply may be housed within or used in conjunction with other components, such as sensors and alarm indicators, for example. In some embodiments, the negative-pressure source 104 may be combined with other components into a therapy unit. For example, in some embodiments, the container 112, the actuator 114, or both may be integral with the negative-pressure source 104. A negative-pressure supply may also have one or more supply ports configured to facilitate coupling and de-coupling the negative-pressure supply to one or more distribution components.
In some embodiments, the actuator 114 may be manually operated to prime the negative-pressure source. In some embodiments, for example, the negative-pressure source 104 may be primed or charged before providing negative-pressure. Priming or charging the negative-pressure source 104 generally refers to any act or actions for preparing or putting the negative-pressure source 104 in a state or condition to generate negative pressure. The negative-pressure source 104 may also be activated after being primed or charged. In some configurations, the charging and activating may be performed in a single continuous step, while in other configurations, the charging and the activating method may be performed in distinctly separate steps.
For example, some embodiments of the negative-pressure source 104 may comprise a moving seal disposed in a working chamber. In some embodiments, for example the seal may be a piston or other barrier configured to reciprocate between a proximal end and a distal end of a working chamber, and the negative-pressure source 104 may be primed by positioning the piston at a distal end. The seal may be positioned by any of a variety of priming mechanisms or actuators, such the actuator 114. The actuator 114 may be a priming key, slider, or push rod, for example. In some embodiments, a force mechanism may be applied to the actuator 114 to move the seal, and the seal may automatically begin to slide back to generate a negative pressure if the force is released. In other embodiments, the negative-pressure source 104 may comprise an activating or release mechanism that is actuated separately from a priming mechanism to initiate the generation of the negative pressure. In some configurations, the activating mechanism may directly block or restrict movement of the sliding seal, while in other configurations, the activating mechanism may restrict or limit flow of fluid into or out of the working chamber. In some examples, the release mechanism may comprise a separate button or lever that is configured to alter communication or flow through a valve coupled to the working chamber.
In some embodiments, the actuator 114 may comprise or consist of a priming key or tool configured to displace sliding seal into a primed position. In some examples, the priming key may comprise an elongate rigid member configured to be positioned in an opening or keyway of the negative-pressure source 104. In some embodiments, the priming key can be used to mechanically move a sliding seal towards a distal end of working chamber until a latch, embedded within the shaft of the priming key, locks into place. In some embodiments the actuator 114 may also serve as a cap to close a working chamber. In some embodiments, the actuator 114 may be configured to hold and maintain the negative-pressure source 104 in a charged state. In other embodiments, the actuator 114 can also be configured for recharging the negative-pressure source 104. For example, the actuator 114 may be used to recharge the negative-pressure source 104 if a leak cause substantial discharge or after emptying the container 112.
The tissue interface 108 can be generally adapted to contact a tissue site. The tissue interface 108 may be partially or fully in contact with the tissue site. If the tissue site is a wound, for example, the tissue interface 108 may partially or completely fill the wound, or may be placed over the wound. The tissue interface 108 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 108 may be adapted to the contours of deep and irregular shaped tissue sites. Moreover, any or all of the surfaces of the tissue interface 108 may have projections or an uneven, course, or jagged profile that can induce strains and stresses on a tissue site, which can promote granulation at the tissue site.
In some embodiments, the tissue interface 108 may be a manifold. A “manifold” in this context generally includes any substance or structure providing a plurality of pathways adapted to collect or distribute fluid across a tissue site under pressure. For example, a manifold may be adapted to receive negative pressure from a source and distribute negative pressure through multiple apertures across a tissue site, 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 across a tissue site.
In some illustrative embodiments, the pathways of a manifold may be interconnected to improve distribution or collection of fluids across a tissue site. In some illustrative embodiments, a manifold may be a porous foam material having interconnected cells or pores. For example, cellular foam, open-cell foam, reticulated foam, porous tissue collections, and other porous material such as gauze or felted mat generally include pores, edges, and/or walls adapted to form interconnected fluid channels. 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.
The average pore size of a foam may vary according to needs of a prescribed therapy. For example, in some embodiments, the tissue interface 108 may be a foam having pore sizes in a range of 400-600 microns. The tensile strength of the tissue interface 108 may also vary according to needs of a prescribed therapy. For example, the tensile strength of a foam may be increased for instillation of topical treatment solutions. In one non-limiting example, the tissue interface 108 may be an open-cell, reticulated polyurethane foam such as GranuFoam® dressing or VeraFlo® foam, both available from Kinetic Concepts, Inc. of San Antonio, Tex.
The tissue interface 108 may be either hydrophobic or hydrophilic. In an example in which the tissue interface 108 may be hydrophilic, the tissue interface 108 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 108 may draw fluid away from a tissue site by capillary flow or other wicking mechanisms. An example of a hydrophilic foam is a polyvinyl alcohol, open-cell foam such as V.A.C. WhiteFoam® dressing available from Kinetic Concepts, Inc. of San Antonio, Tex. 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.
The tissue interface 108 may further promote granulation at a tissue site when pressure within the sealed therapeutic environment is reduced. For example, any or all of the surfaces of the tissue interface 108 may have an uneven, coarse, or jagged profile that can induce microstrains and stresses at a tissue site if negative pressure is applied through the tissue interface 108.
In some embodiments, the tissue interface 108 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 108 may further serve as a scaffold for new cell-growth, or a scaffold material may be used in conjunction with the tissue interface 108 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 106 may provide a bacterial barrier and protection from physical trauma. The cover 106 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 106 may be, 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 106 may have a high moisture-vapor transmission rate (MVTR) in some applications. For example, the MVTR may be at least 300 g/m{circumflex over ( )}2 per twenty-four hours in some embodiments. In some example embodiments, the cover 106 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.
An attachment device may be used to attach the cover 106 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 that extends about a periphery, a portion, or an entire sealing member. In some embodiments, for example, some or all of the cover 106 may be coated with an acrylic adhesive having a coating weight between 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.
The container 112 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. In some embodiments, the container 112 may be integral with other components, such as the dressing 102 or the negative-pressure source 104.
In operation, the tissue interface 108 may be placed within, over, on, or otherwise proximate to a tissue site. The cover 106 may be placed over the tissue interface 108 and sealed to an attachment surface near the tissue site. For example, the cover 106 may be sealed to undamaged epidermis peripheral to a tissue site. Thus, the dressing 102 can provide a sealed therapeutic environment proximate to a tissue site, substantially isolated from the external environment, and the negative-pressure source 104 can reduce the pressure in the sealed therapeutic environment. Negative pressure applied across the tissue site through the tissue interface 108 in the sealed therapeutic environment can induce macrostrain and microstrain in the tissue site, as well as remove exudates and other fluids from the tissue site, which can be collected in container 112.
The dressing 202 may be an example embodiment of the dressing 102. An integrated attachment port 206 may be configured to connect the dressing 202 to the tube 204, or directly to the therapy unit 200. In some embodiments, the tube 204 or the therapy unit 200 may be configured to rotate about an axis of the attachment port 206. In some embodiments, the attachment port 206 may be configured to rotate around a base 210 and/or to bend toward and/or away from the dressing 202. For example, the attachment port 206 may be configured to freely rotate about 360 degrees or more, or to provide a limited rotation range less than about 360 degrees. The attachment port 206 may have a fixed orientation that is generally parallel to the plane of the sealant layer, but in other configurations, may be angled below the parallel plane or above the parallel plane. In still other examples, the attachment port 206 may be configured to bend or pivot relative to the dressing 202. The range of bending or pivoting may be from about 0 degrees to about 45 degrees or about 90 degrees, from about 0 degrees to 135 degrees or about 180 degrees, or from about −15 degrees or about −30 degrees to about 45 degrees, about 90 degrees, about 135 degrees, about 180 degrees, 195 degrees or about 210 degrees. In certain embodiments, the attachment port 206 may be configured to rotate and pivot.
The therapy unit 200 or the tube 204 may be coupled to the attachment port 206 by any of a variety of mechanisms. For example, the attachment port 206 may comprise a resistance or interference fitting which may be inserted into the tube 204 or a connector interface 211 of the therapy unit 200. The resistance fitting may comprise one or more flanges configured to resist decoupling. In other examples, the tube 204 may be inserted into the lumen or opening of the attachment port, and the attachment port may comprise a push-in fitting, such as a John Guest fitting (Middlesex, UK). In other embodiments, connectors on both components may be used, including threaded or mechanical interlocking fits. The connectors may be configured to facilitate both coupling and decoupling of the components.
In the example embodiment depicted in
One or more connectors may also comprise a locking mechanism to facilitate decoupling and/or attachment. In some examples, a locking mechanism may resist inadvertent decoupling from the therapy unit 200 and/or the dressing 202. In the example depicted in
In some embodiments, the therapy unit 200 may comprise a rigid polymer configured to generally maintain its shape under negative pressure. The therapy unit 200 can be made of any suitable polymer such as polycarbonate, co-polyester, polyethylene, polypropylene, acrylic, ABS, glass, or any other polymer known to those skilled in the art.
The housing 310 may be fabricated from a rigid polymer adapted to maintain the external shape of the suction chamber shape under reduced pressure. In some embodiments, the entire body of the housing 310 may be transparent. In other embodiments, the housing 310 may comprise a non-transparent body but with an inspection window. In some example embodiments, the housing 310 may have a longitudinal axis and an elliptical cross-section transverse to the longitudinal axis.
An opening such as a keyway 432 may be provided in the proximal cap 330 to permit insertion of the actuator 214. The distal end 312 and/or the proximal end 314 of the housing 310 may also comprise notches 460 and 470, respectively, which may be configured to facilitate coupling to the distal cap 320 and/or the proximal cap 330, respectively. Notches 472 or apertures may also be provided for attaching the spring assembly 410 to the housing 310.
The piston seal 710 may be detachably coupled to the piston 720 or in some embodiments, the piston seal 710 and the piston 720 may be integrally formed. In the example embodiment of
The piston 720 may also comprise a central opening 740. The central opening 740 may be configured to provide passage of springs, for example. The piston 720 may further comprise convex supports 746 adjacent to the central opening 740. In some example embodiments, the convex supports 746 may have a concave region 748.
As illustrated in the example of
The spring 1025 is illustrative of any elastic object that can suitably store mechanical energy if disturbed from its neutral position, including a coil spring or a flat spring. The spring 1025 may be a flat spring in some embodiments, and may be parallel or coplanar to the shaft 1005 in some embodiments. In more particular examples, the spring 1025 may be a flat spring, which may have a neutral axis collinear with a neutral axis of the shaft 1005. For example, in the embodiment of
In some example embodiments, the actuator 214 may further include a lever 1060 configured to operate the latch 1020. The lever 1060 may be coupled to the spring 1025 in some embodiments, or more specifically, may be integral with the spring 1025 as illustrated in the example of
The actuator 114 may also comprise a centralizer 1065 in some example embodiments. The centralizer 1065 may be a rigid element, an elastic element, or a combination of rigid and elastic elements. As illustrated in the example of
As shown in the example embodiment of
The piston assembly 405 generally divides the working chamber 1400 into a proximal chamber 1405 and a distal chamber 1410. The piston assembly 405 can reciprocate in the working chamber 1400 between the distal end 312 and the proximal end 314 of the housing 310, changing the volume of the proximal chamber 1405 and the distal chamber 1410 as it moves. For example, the piston assembly 405 can move along a longitudinal axis of the working chamber toward the proximal end 314 to increase the volume of the distal chamber 1410. The maximum and minimum volume of the distal chamber 1410 may vary, but a volume of less than 1000 cc may be suitable for many applications. A volume of 150 cc or less may be preferable for some applications. The piston assembly 405 preferably provides a seal between the proximal chamber 1405 and the distal chamber 1410. For example, the ridges 714 and 716 may be configured to be in a sliding contact with the interior surface of the housing 310, providing a sealed contact while limiting sliding friction.
The springs 415 may couple the piston assembly 405 to the spring assembly 410. For example, each of the springs 415 may have a proximal end coupled to one of the bushings 530, which may be mounted on the rails 512 of the spring retainer 510. Each of the springs 415 may further have a first portion rolled around a respective bushing 530, a second portion extending through the central opening 740 of the piston 720, and a distal end coupled to the spring retaining structures 942. In the example embodiment of
Although the example embodiments of the piston assembly 405 and the spring assembly 410 are illustrated with only two springs, other configurations may be suitable for some applications. The number of springs, the type of springs, and the width and length of the springs may be varied, and in other examples, elastic elements such as sealed pneumatic shocks may be used.
From the release position of
In the release position, the actuator 214 may optionally be removed from the housing 310, and the seal 480 may be inserted into the keyway 432. The seal 480 may be any type of seal that may prevent entry of undesired contaminants or other environmental agents (such as water) into the working chamber 1400. In some embodiments, the seal 480 may be tethered to the proximal cap. In still other examples, the seal 480 may be configured with a passageway or slit, and may comprise a deformable material that permits insertion and/or removal of the actuator 214 and reseals upon removal of the actuator 214.
In operation, the dressing 202 may be placed within, over, on, or otherwise proximate to a tissue site, creating a substantially sealed treatment space between the dressing 202 and the tissue site. The dressing 202 may be fluidly coupled to the distal chamber 1410, creating a substantially closed system comprising the distal chamber 1410 and the treatment space. For example, the tube 204 may couple the dressing 202 to the fitting 342.
The springs 415 bias the piston assembly 405 toward the proximal end 314 of the therapy unit 200. In the example embodiment of
From a charged position, such as illustrated in the example embodiment of
The reduction in pressure can also draw exudate from the tissue site into the distal chamber 1410. In some embodiments, the distal chamber 1410 can be used to collect exudate, similar or analogous to the container 112.
Leaks or other conditions can increase the pressure in the closed system, disturbing the state of equilibrium between elastic force of the springs 415 and the pressure differential across the piston assembly 405. The elastic force of the springs 415 can move the piston assembly 405 further toward the proximal end 314, increasing the volume of the distal chamber 1410 and decreasing the pressure until a new equilibrium condition is reached, or until the piston assembly 405 is stopped by the spring assembly 410 or other limit structure. In some embodiments, the springs 415 can be selected or calibrated to provide a prescribed pressure in the closed system, and can maintain a substantially constant pressure across the range of motion of the piston assembly 405 in the working chamber 1400.
The therapy unit 200 may be discharged, for example, if movement of the piston assembly 405 toward the proximal end 314 is constrained and the pressure in the closed system exceeds the prescribed pressure. In some embodiments, the therapy unit 200 may be charged again when it is discharged, or from any interim state. For example, the actuator 214 may be used to return the piston assembly 405 to the distal end 312. The actuator 214 may be returned to the locked position of
The systems, apparatuses, and methods described herein may provide significant advantages. For example, an actuator such as the actuator 214 can be released with a push-down motion, and can be released with a single hand if held against a firm surface. An actuator such as the actuator 214 also eliminates or substantially reduces risk of inadvertently locking a negative-pressure source while recharging. An actuator with a low profile handle, such as the example embodiment of the actuator 214 of
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. 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 102, the container 112, or both may be eliminated or separated from other components for manufacture or sale. In other example configurations, the actuator 214, the spring carrier 520, or both may also be manufactured, configured, assembled, or sold independently of other components.
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 herein may also be 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.
This application claims the benefit, under 35 USC § 119(e), of the filing of U.S. Provisional Patent Application Ser. No. 62/293,318, entitled “A NEGATIVE-PRESSURE THERAPY APPARATUS WITH PUSH-TO-RELEASE ACTUATOR” filed Feb. 9, 2016, which is incorporated herein by reference for all purposes.
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Number | Date | Country | |
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20170224885 A1 | Aug 2017 | US |
Number | Date | Country | |
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62293318 | Feb 2016 | US |