reduced pressure system, method for regulating a therapeutic pressure in a reduced pressure therapy

专利摘要:
systems, methods and apparatus for providing feedback to a reduced pressure therapy are described. a regulator may include a fluidly coupled feed chamber to a cover, a fluidly coupled control chamber to the cover, a load chamber fluidly coupled to the feed chamber through a port and a regulating valve that may be operated to control fluid communication through the port based on a pressure differential between the control chamber and a target pressure. The feedback system may include a printed circuit board, a pressure sensor, and a signal interface communicatively coupled to the printed circuit board. The pressure sensor may be fluidly coupled to the control chamber to determine the pressure in the control chamber. The signal interface may indicate a state of reduced pressure therapy. A potential source may be communicatively coupled to the printed circuit board, pressure sensor, and indicator.
公开号:BR112016007139A2
申请号:R112016007139
申请日:2014-08-29
公开日:2020-06-16
发明作者:Brian Locke Christopher；A. Pratt Benjamin
申请人:Kci Licensing, Inc.；
IPC主号:

专利说明:

REDUCED PRESSURE SYSTEM, METHOD FOR REGULATING A THERAPEUTIC PRESSURE IN A REDUCED PRESSURE THERAPY SYSTEM, AND FEEDBACK SYSTEM TO MONITOR THE REDUCED PRESSURE THERAPY APPLICATION BY A REDUCED PRESSURE THERAPY SYSTEM
RELATED ORDER
[001] The present invention claims the benefit, under 35 USC § 119 (e), of US Provisional Patent Application with serial number 61 / 885,758, called DISPOSABLE REDUCED-PRESSURE THERAPY SYSTEM WITH ELECTRONIC FEEDBACK, submitted on October 2 2013, which is incorporated herein by reference for all purposes.
TECHNICAL FIELD
[002] The subject described here relates in general to the monitoring of reduced pressure therapy, and, more particularly, but not by way of limitation, to electronic feedback of reduced pressure therapy powered by a wall suction source.
BACKGROUND
[003] Clinical studies and practice have shown that reduced pressure in the vicinity of a tissue site can increase and accelerate the growth of new tissue at the tissue site. The applications of this phenomenon are several, but it has proved to be particularly advantageous in the treatment of wounds. Regardless of the etiology of a wound, be it trauma, surgery, or another cause, proper wound care is important to the end result. The treatment of wounds by means of reduced pressure is commonly referred to as reduced pressure therapy, but it may also be known by other names, including negative pressure wound therapy and vacuum therapy, for example. Reduced pressure therapy can provide several benefits, including migration of epithelial tissues
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2/61 and subcutaneous, better blood flow and micro-deformation of tissue in a wound site. Together, these benefits can increase the development of granulation tissue and reduce healing times.
[004] Although the clinical benefits of reduced pressure therapy are widely known, the cost and complexity of reduced pressure therapy can be a limiting factor in its application and the development and operation of reduced pressure systems, components and processes continue to present significant challenges for manufacturers, healthcare providers and patients.
RESUME
[005] Illustrative embodiments of systems, methods and devices for regulating pressure are described below. Such an illustrative embodiment can be described as a reduced pressure system having a cover, a regulator and a feedback system. The regulator generally includes a feed chamber that can be fluidly coupled to the cover via a feed lumen, a control chamber adapted to be fluidly coupled to the cover via a feedback lumen, and a coupled load chamber fluidly to the feed chamber through a door. A regulator valve can be coupled to the control chamber and can be operated to reciprocate at least partially within the control chamber to control fluid communication through the port based, at least partially, on a differential between a control pressure in the chamber control and a therapy pressure in the feed chamber. The feedback system may include a printed circuit board and a pressure sensor communicatively coupled to the printed circuit board. The pressure sensor can be coupled
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3/61 fluidly to the control chamber to determine the control pressure in the control chamber. The feedback system may also include an indicator, such as a signal interface, communicatively coupled to the printed circuit board and the pressure sensor. The indicator can be adapted to signal an operating state of the regulator. A potential source can also be communicatively coupled to the printed circuit board, pressure sensor and indicator to supply electrical potential to the printed circuit board, pressure sensor and indicator.
[006] Another illustrative embodiment relates to a method for regulating therapeutic pressure. The method generally includes fluidly coupling a collector to a feed chamber through a feed lumen and fluidly coupling the collector to a control chamber through a feedback lumen. The feed chamber can be fluidly coupled to a load chamber and the control chamber can be fluidly coupled to a pressure sensor. A charge pressure in the charge chamber can be reduced below a predetermined pressure, and fluid communication can be regulated between the supply chamber and the charge chamber based, at least partially, on a differential between a control pressure in the chamber control and a therapy pressure. Therapy pressure can be supplied from the supply chamber to the collector, and a collector pressure in the collector can be communicated fluidly to the control chamber. The control pressure in the control chamber can be measured and a state of the control pressure in the control chamber can be indicated in response to the measurement of the control pressure in the control chamber.
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[007] Yet another illustrative embodiment relates to a feedback system for monitoring the application of reduced pressure therapy. The feedback system may include a printed circuit board and a pressure sensor. The pressure sensor can be communicatively coupled to the printed circuit board and adapted to be fluidly coupled to a control chamber to determine a control pressure. The feedback system can also include an indicator communicatively coupled to the printed circuit board and the pressure sensor, and can be configured to indicate a state of the control pressure. A potential source can also be communicatively coupled to the printed circuit board, pressure sensor and indicator to supply electrical potential to the printed circuit board, pressure sensor and indicator.
[008] Other features and advantages will become apparent with reference to the figures and detailed description that follows.
BRIEF DESCRIPTION OF THE FIGURES
[009] Figure 1 is a functional block diagram of an exemplary embodiment of a reduced pressure therapy system that can regulate therapeutic pressure according to this specification;
[010] Figures 2A-2B are schematic cross sections of an exemplary embodiment of a regulator in the reduced pressure therapy system;
[011] Figure 3A is a schematic cross section of another embodiment of a regulator for use in the reduced pressure therapy system;
[012] Figure 3B is an exploded schematic view of the regulator in Figure 3A;
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[013] Figure 3C is a schematic cross section of the regulator in Figure 3A having a regulator valve in an open position;
[014] Figure 4 is a schematic cross section of an exemplary embodiment of a reduced pressure therapy system using the regulator in Figure 3A;
[015] Figure 5 is a schematic cross section of an exemplary embodiment of a feedback system using the regulator in Figure 3A; and
[016] Figure 6 is a schematic cross section of an exemplary embodiment of another feedback system using the regulator in Figure 3A.
DETAILED DESCRIPTION
[017] New and useful systems, methods and devices associated with pressure monitoring are presented in the attached claims. Objectives, advantages and a preferential way of making and using the systems, methods and devices can be better understood by reference to the detailed description that follows in conjunction with the attached figures. The description provides information that allows a person skilled in the art to make and use the claimed object, but may omit certain details already well known in the art. In addition, descriptions of various alternatives using terms such as or do not necessarily require mutual exclusivity, unless clearly required by the context. The claimed object may also comprise alternative embodiments, variations and equivalents not specifically described in detail. The following detailed description should therefore be taken as illustrative and not limiting.
[018] Exemplary embodiments can also be described here in the context of applications for
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6/61 reduced pressure therapy, but many of the features and advantages are readily applicable to other environments and industries. Spatial relationships between several elements or with the spatial orientation of several elements can be described as represented in the attached figures. In general, such relationships or orientations assume a frame of reference consistent with or related to a patient in a position to receive reduced pressure therapy. However, as should be recognized by those skilled in the art, this frame of reference is a purely descriptive file and is not a strict prescription.
[019] Figure 1 is a simplified function block diagram of an exemplary embodiment of a reduced pressure therapy system 100 that can regulate therapeutic pressure according to this specification. As shown in the illustrative embodiment of Figure 1, the reduced pressure therapy system 100 can include a cover 102 fluidly coupled to a reduced pressure source 104. A regulator or controller, such as a regulator 106, can also be fluidly coupled to the cover 102 and the reduced pressure source 104. The cover 102 generally includes a fabric, such as a fabric 108 and a fabric interface, such as a manifold 110. The reduced pressure therapy system 100 can also include a fluid container, such as a container 112, fluidly coupled to the cover 102 and the reduced pressure source 104.
[020] In general, the components of the reduced pressure therapy system 100 can be coupled directly or indirectly. For example, the reduced pressure source 104 can be coupled directly to regulator 106 and indirectly coupled to cover 102 through the
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Regulator 106. The components can be fluidly coupled to each other to provide a pathway for the transfer of fluids (i.e. liquid and / or gas) between the components. In some embodiments, the components can be fluidly coupled to a tube, for example. A tube as used herein refers generally to a tube, pipe, hose, conduit or other structure with one or more lumens adapted to communicate fluids between two ends. Typically, a tube is an elongated, cylindrical structure with some flexibility, but the geometry and stiffness can vary. In some embodiments, the components can, additionally or alternatively, be coupled by means of physical proximity, being integrated into a single structure, or being formed from the same piece of material. The coupling may also include mechanical, thermal, electrical or chemical coupling (as a chemical bond) in some contexts.
[021] When in operation, a fabric interface, such as the collector 110, can be placed inside, over, against or otherwise adjacent to a fabric location. For example, collector 110 can be placed against a tissue site, and tissue 108 can be placed near collector 110 and sealed with tissue close to the tissue site. The tissue near a tissue site is often unaffected epidermis peripheral to the tissue site. Thus, cover 102 can provide a sealed therapeutic environment close to the tissue site. The sealed therapeutic environment can be substantially isolated from the external environment, and the reduced pressure source 104 can reduce the pressure in the sealed therapeutic environment. The reduced pressure applied uniformly across the tissue interface in the sealed therapeutic environment can
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8/61 induce macro-deformation and micro-deformation at the tissue site, as well as remove exudates and other fluids from the tissue site. Exudates and other removed fluids can be collected in container 112 and disposed of appropriately.
[022] The mechanics of the fluid of using a reduced pressure source to reduce pressure at another component or location, such as within a sealed therapeutic environment, can be mathematically complex. However, the basic principles of fluid mechanics applicable to reduced pressure therapy are generally well known to those of skill in the art, and the process of reducing pressure can be described illustratively here as providing, distributing or generating reduced pressure, for example.
[023] In general, exudates and other fluids flow at low pressure along a fluid path. This guidance is generally assumed for purposes of describing the various characteristics and components of reduced pressure therapy systems referred to herein. Thus, in the context of reduced pressure therapy, the term downstream typically implies a position in a fluid pathway relatively closer to a source of reduced pressure and, in contrast, the term upstream implies a position relatively further away from a source reduced pressure. Similarly, it may be convenient to describe certain characteristics in terms of inflow or outflow in such a frame of reference. However, a fluid pathway can also be reversed in some applications, such as replacing a source of positive pressure, and this descriptive convention should not be understood as a limiting convention.
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[024] The term local tissue in this context refers generically to a wound or defect located on or within a tissue, including, but not limited to, bone tissue, adipose tissue, muscle tissue, neural tissue, tissue dermal, vascular tissue, connective tissue, cartilage, tendons or ligaments. A wound can include chronic, acute, traumatic, subacute and dehiscent wounds, partial thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts, for example. The term local tissue can also refer to areas of tissue that are not necessarily injured or defective, but are areas in which you may wish to add or promote the growth of additional tissue. For example, reduced pressure on certain tissue areas can be used to grow additional tissue that can be harvested and transplanted to another tissue location.
[025] Reduced pressure generally refers to a pressure lower than the local ambient pressure, such as the ambient pressure in a local environment external to a sealed therapeutic environment provided by cover 102. In many cases, the local ambient pressure can also be the atmospheric pressure in the vicinity of a patient. Alternatively, the pressure may be less than a tissue-associated hydrostatic pressure at the tissue site. Unless otherwise stated, the pressure values referred to here are gauge pressures. Similarly, references to increases in reduced pressure typically refer to a reduction in absolute pressure, while reductions in reduced pressure typically refer to an increase in absolute pressure.
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[026] A reduced pressure source, such as the reduced pressure source 104, can be an air reservoir at reduced pressure, or it can be a manually moved or powered device that can reduce pressure in a sealed volume, such as a vacuum pump, a suction pump, a wall suction port available at many health facilities, or a micro pump, for example. A reduced pressure source can be stored inside or used in conjunction with other components, such as sensors, processing units, alarm indicators, memory, databases, software, display devices, or operator interfaces that further facilitate the reduced pressure therapy. Although the amount and nature of the reduced pressure applied to a tissue site may vary according to therapeutic requirements, the pressure typically ranges from -5 mm Hg (-667 Pa) to -500 mm Hg (-66.7 kPa). Common therapeutic ranges are between -75 mm Hg (-9.9 kPa) and -300 mm Hg (-39.9 kPa).
[027] A fabric interface, such as collector 110, can generally be adapted to contact a fabric location or other layers of a cover, such as cover 102. A fabric interface can be partially or totally in contact with a tissue location. If a tissue site is a wound, for example, a tissue interface can partially or fully fill the wound, or it can be placed over the wound. A tissue interface can take many forms and can have different sizes, shapes or thicknesses, depending on several 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 a fabric interface can be
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11/61 adapted to the contours of fabric sites of irregular depth and shape.
[028] In general, a collector, such as a collector 110, for example, is a substance or structure adapted to distribute or remove fluids from a tissue site. A collector can include channels or flow paths that can deliver fluids provided to, and removed from, a tissue site. In an illustrative embodiment, the channels and flow paths can be interconnected to improve the distribution of fluids provided to, or removed from, a tissue site. For example, a collector may be an open cell foam, collection of porous tissue, and other porous material such as gauze or felt material that generally includes structural elements arranged to form flow channels. Liquids, gels and other foams can also include or be treated to include flow channels.
[029] In an illustrative embodiment, the collector 110 may be a porous foam cushion with interconnected cells adapted to distribute reduced pressure over a tissue site. The foam material can be hydrophobic or hydrophilic. In a non-limiting example, collector 110 may be cross-linked polyurethane foam such as GranuFoam® coverage available from Kinetic Concepts, Inc. of San Antonio, Texas.
[030] In some embodiments, such as embodiments in which the collector 110 can be made of a hydrophilic material, the collector 110 can also drain fluid from a tissue site while continuing to distribute reduced pressure to the site of fabric. The drainage properties of the collector 110 can remove fluid from a tissue site by capillary flow or other
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12/61 absorption mechanisms. An example of a hydrophilic foam is an open cell foam of polyvinyl alcohol as a V.A.C. WhiteFoam® marketed by Kinetic Concepts, Inc. of San Antonio, Texas. Other hydrophilic foams may include those made of polyether. Other foams that may exhibit hydrophilic characteristics include hydrophilic foams that have been treated or coated to provide hydrophilicity.
[031] A tissue interface can further promote granulation in a tissue site if the pressure within the sealed therapeutic environment is reduced. For example, any or all of the surfaces of the manifold 110 may have an irregular, rough or indented profile that can induce microdeformations and stresses in a tissue location if reduced pressure is applied through the manifold 110.
[032] In some embodiments, a fabric interface can be constructed from bioresorbable materials. Suitable bioresorbable materials may include, without limitation, a polymeric mixture of polylactic acid (PLA) and polyglycolic acid (PGA). The polymeric mixture can also include without limitation polycarbonates, polyfumarates and capralactones. The tissue interface can further serve as a support for new cell growth, or a support material can be used in conjunction with the tissue interface to promote cell growth. In general, a support material can be a biocompatible or biodegradable substance or structure used to enhance or promote cell growth or tissue formation, such as a three-dimensional porous structure that provides a model for cell growth. Illustrative examples of
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Supporting materials include calcium phosphate, collagen, PLA / PGA, coral hydroxyapatites, carbonates or processed allograft materials.
[033] Fabric 108 is an example of a sealing member. A sealing member can be constructed from a material that can provide a fluid seal between two environments or components, such as between a therapeutic environment and a local external environment. The sealing member can be, for example, a semi-permeable elastomeric film or barrier which can provide a suitable seal to maintain a reduced pressure in a tissue location for a given source of reduced pressure. For semi-permeable materials, the permeability should generally be low enough to maintain a desired reduced pressure. A connecting device can be used to attach a sealing member to a connecting surface, such as unaffected epidermis, a joint or other sealing member. The connection device can take various forms. For example, a connector may be a medically acceptable pressure sensitive adhesive that extends over a periphery, a portion or throughout a sealing member. Other exemplary embodiments of a connector may include a double-sided tape, paste, hydrocolloid, hydrogel, silicone gel, organogel or an acrylic adhesive.
[034] A container such as the container 112 of Figure 1 generally includes a container, bag, bottle, flask, or other fluid collection device. Container 112, for example, can be used to manage exudates and other fluids taken from a tissue site. In many environments, a rigid container may be preferred or necessary to collect, store and dispose of fluids. In other environments, fluids can be
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14/61 disposed of properly without storage in a rigid container, and a reusable container can reduce waste and costs associated with reduced pressure therapy.
[035] In general, reduced pressure therapy can be beneficial for wounds of all degrees of severity, but the cost and complexity of reduced pressure therapy systems often limit the application of reduced pressure therapy to large, high wounds. exudation present in patients undergoing acute or chronic care, as well as other serious wounds that are not readily susceptible to healing without application of reduced pressure. Many developing regions may not have access to electrical reduced pressure sources dedicated to reduced pressure therapy. Instead, these regions may rely on sources of wall suction to provide reduced pressure. These sources of wall suction can be seen as a practical and suitable alternative with lower costs for a dedicated therapy unit with electronic control.
[036] Wall suction sources are capable of providing continuous or near continuous supply at reduced pressure. However, wall suction sources can provide a wide range of reduced pressure and may require an operator to select an appropriate reduced pressure to be fed. If the reduced pressure is set too low at the wall suction source, exudates and other wound fluids will not be removed from the tissue site. If the reduced pressure is too high, reduced pressure therapy can cause internal bleeding and further damage a tissue site. For at least these reasons, the treatment of a reduced pressure tissue site provided
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15/61 by a wall suction source requires regulation of the amount of reduced pressure fed to the tissue site.
[037] The reduced pressure therapy system 100 can overcome these and other shortcomings by providing feedback and mechanical regulation of therapeutic pressure. In some embodiments, for example, a regulator can regulate fluid communication between a supply chamber and a charge chamber, and a feedback system can provide feedback to alert operators to a state of operation of reduced pressure therapy during the application of reduced pressure therapy. For example, a feedback system can provide an operator with an operating state of one or more of the following: a control pressure, a supply pressure, a differential between the control pressure and the supply pressure, a leakage condition , a blocking condition, a full vessel condition and an overpressure condition. In some embodiments, the reduced pressure therapy system 100 can provide a highly configurable, economical, disposable, single-patient or reusable system.
REGULATORS
[038] Figures 2A-2B are simplified schematic cross sections illustrating details of an exemplary embodiment of regulator 200. Regulator 200 is an exemplary embodiment of regulator 106 in Figure 1. As illustrated, regulator 200 may include a packaging structure 201 with a loading chamber 202, a feeding chamber 204 and a control chamber 20 6. The loading chamber 202 may be fluidly coupled to the feeding chamber 204 through a conduit,
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16/61 passage or port, such as a loading port 205. A port 208 can provide fluid communication between the control chamber 206 and an ambient pressure source. The loading chamber 202 may also include a port, such as a port 210, which may be fluidly coupled to a source of reduced pressure, such as the source of reduced pressure 104. The loading chamber 202 may be adapted to receive reduced pressure of a device that can be actuated manually or alternatively that can be powered by electrical or other means.
[039] A feed port 212 can fluidly couple feed chamber 204 to a cover, such as cover 102 in Figure 1. A control port 214 can fluidly couple control chamber 206 to the cover. For example, in one embodiment, a first lumen such as a feed lumen 216a, can fluidly connect feed port 212 and feed chamber 204 to a cover. A second lumen, such as a feedback lumen 216b, can fluidly couple control port 214 and control chamber 206 to the cover. In some embodiments, the feed lumen 216a and the feedback lumen 216b can be arranged within a single multi-lumen tube, such as a tube 218. In other embodiments, more than one tube can be used for attach a cover to the power port 212 and the control port 214.
[040] A T-connector 215 can be coupled to the feedback lumen 216b. The T-connector 215 may have a first pass 215a and a second pass 215b. The first passage 215a and the second passage 215b can be perpendicular to and be in fluid communication with each other. The first passage 215a can be fluidly coupled in line between the control chamber 206 and a
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17/61 coverage. For example, the first passage 215a can be fluidly coupled to the feedback lumen 216b. The second passage 215b may be fluidly coupled to another device, such as a pressure sensor, fluid source or sampling device, for example. In some embodiments, a pressure sensor may be fluidly coupled to the second pass 215b and be in fluid communication with a control pressure in the control chamber 206.
[041] A T-217 connector can be coupled to the power lumen 216a. The T-connector 215 may have a first pass 217a and a second pass 217b. The first passage 217a and the second passage 217b can be perpendicular to and be in fluid communication with each other. At least one of the passages can be fluidly coupled in line between the control chamber 204 and a cover. For example, the first passage 217a can be fluidly coupled to the feed lumen 216a. The second passage 217b can be fluidly coupled to another device, such as a pressure sensor, fluid source or sampling device, for example. In some embodiments, a pressure sensor may be fluidly coupled to the second passage 217b and be in fluid communication with a control pressure in the supply chamber 204.
[042] A regulator valve 220 can be operatively associated with the loading port 205 to regulate fluid communication between the loading chamber 202 and the supply chamber 204. In some embodiments, the regulator valve 220 may include an actuator , a valve body and an elastic member. An actuator can be a flexible or mobile barrier, such as a piston 222. A valve body can be, for example, a structure
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18/61 generally rigid having a first end coupled to, adjacent to, abutting or otherwise engaging piston 222, and capable of being moved with the piston, such as a stem 224. A second end of the valve body can generally be dimensioned and configured to engage and / or seal the loading door 205. In the illustrative embodiments, the rod 224 can extend through a partition into the feed chamber 204. An elastic member can be a spring, a rubber or other elastic structure, such as a regulator spring 226, for example. The regulator spring 226 can generally be arranged between piston 222 and the loading port 205. The regulator spring 226 can be arranged inside the control chamber 206, but can be arranged in the feed chamber 204 in other forms. achievement. The regulator spring 226 in this embodiment can be a helical spring that is coaxial with the stem 224. The regulator spring 226 can press the piston 222 against an ambient pressure 228 in the control chamber 206.
[043] In some embodiments, the packaging structure 201 can be formed of two components. For example, the packaging structure 201 can be formed from a lower packaging structure 201a and an upper packaging structure 201b, as shown in the illustrative embodiments of Figures 2A-2B. In this example, the lower housing 201a and the upper housing 201b both include a rear wall, a side wall adjacent the rear wall and an open end opposite the rear wall. Both the lower housing structure 201a and the upper housing structure 201b may have an outer dimension less than an inner dimension of the
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19/61 another, so that one can be inserted into the other to form a structure that provides a substantially closed interior. In some embodiments, the lower housing structure 201a and the upper housing structure 201b can be engaged to allow relative movement between them. In more particular embodiments, the lower housing 201a and the upper housing 201b may have both cylindrical side walls and rounded rear walls.
[044] The loading chamber 202 can generally be defined by adjacent walls of the housing structure 201, such as a rear wall of the housing structure 201, a wall or side walls of the housing structure 201, and a partition within the housing structure. packaging 201, such as the chamber wall 207a. The feed chamber 204 can also generally be defined by adjacent walls within the housing structure 201. For example, the feed chamber 204 in Figures 2A-2B can generally be defined by the chamber wall 207a, a wall or side walls of the packaging structure 201, and another partition, such as chamber wall 207b. The control chamber 206 can be similarly described, for example, as a chamber defined by the chamber wall 207b, the wall or side walls of the housing 201, and another rear wall of the housing 201. In this form of embodiment, the loading chamber 202 and the feeding chamber 204 may have a common wall, such as the chamber wall 207a, for example. The feed chamber 204 and the control chamber 206 may have a common wall, such as the chamber wall 207b, for example. The loading chamber 202 and the loading chamber
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20/61 feed 204 can be insulated in terms of fluids in relation to each other except through the loading port 205. The load chamber 202 and the feed chamber 204 can be isolated in terms of fluids in relation to the surrounding environment. And the control chamber 206 can be isolated in terms of fluids in relation to the loading chamber 202 and the feeding chamber 204.
[045] The regulator valve 220 in this example can be arranged partially inside the control chamber 206 and partially inside the feed chamber 204, with circumferential edges of the piston 222, leaning against or coupling to the wall or side walls of the control chamber 206. The interface between piston 222 and the walls of control chamber 206 can also provide a fluid seal, dividing control chamber 206 into a region of ambient pressure 228 and a region of control pressure 230. However , the regulator valve 220 can also reciprocate within the control chamber 206 while maintaining the fluid seal. For example, regulator valve 220 can additionally include flexible orings arranged between piston 222 and the side wall of control chamber 206, and o-rings can be lubricated so that regulator valve 220 can reciprocate within the control chamber 206.
[046] In operation, the pressure in the feed chamber 204 can be distributed to a remote chamber, environment or other location through the feed port 212. For example, the pressure in the feed chamber 204 can be distributed to a controlled environment, such as a sealed therapeutic environment associated with the reduced pressure therapy system 100. The control pressure 230 in the control chamber 206 can be equalized with the pressure at the remote location via the
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21/61 control port 214. In reduced pressure therapy applications, the control pressure 230 must be less than the ambient pressure 228, resulting in a pressure differential across regulator valve 220. To simplify the additional description, the force on regulator valve 220 resulting from the pressure differential on opposite sides of piston 222 can be referred to as differential force. Regulator spring 226 also generally exerts a force on regulator valve 220. In expected operating ranges, the force of regulator spring 226 is directly proportional to a displacement of the spring ends of regulator 226 from a relaxed state. Thus, if the control pressure 230 is lower than the ambient pressure 228, the differential force on the piston 222 tends to compress the regulator spring 226 and, consequently, the force of the regulator spring 226 opposes the differential force. The differential force and the spring force of the regulator 226 can be combined to determine a resulting force acting on the regulator valve 220. The resulting force can cause the regulator valve 220 to move reciprocally within the control chamber 20 6, such as along a central axis 231 aligned with the loading port 205.
[047] Regulator spring 226 can be selected, adjusted, modified, tuned or otherwise calibrated so that the control pressure 230 must fall below a threshold value (such as a target pressure) before the force The resultant being able to move the regulator valve 220 to a position that closes the loading door 205. In some embodiments, for example, the piston 222 can rotate within the housing 201 to adjust the compression of the regulator spring 226. In the illustrative embodiments of Figures 2A-2B, piston 222 includes a projection 232 that can be combined
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22/61 rigidly with a sleeve 234 of the housing structure 201b, and the stem 224 can be threaded or have a threaded portion coupled with the protrusion 232. The stem 224 can be radially locked with the housing structure 201 with a key feature . In such embodiments, the piston 222 and the sleeve 234 are generally blocked radially and the compression of the regulator spring 226 can be adjusted by turning the housing structure 201b, which can cause the piston 222 to rotate relative to the stem 224 The change in compression of regulator spring 226 results in a change in the spring force of regulator 22 6 acting on regulator valve 220, and thus a change in the control pressure limit value 230 required to actuate the valve of regulator 220. In many applications, this control pressure limit value 230 must generally correlate with a prescribed target pressure for reduced pressure therapy, and can be referred to here as the therapy pressure or therapeutic pressure. Thus, in some embodiments, the therapy pressure can be adjusted by rotating the upper housing structure 201b. In even more particular embodiments, the upper housing structure 201b can be calibrated to indicate various levels of therapy pressure.
[048] Thus, the loading chamber 202 can be loaded to reduce the pressure in the loading chamber, and the pressure in the therapeutic environment can be regulated based on a differential between the therapy pressure and the control pressure 230. For example , the pressure can be regulated by balancing the spring force of the regulator 22 6 and a differential force. A differential force on piston 222 can be produced by a pressure differential across the piston
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222, such as the differential between control pressure 230 on one side of piston 222 and ambient pressure 228 on an opposite side of piston 222, for example. For reduced pressure therapy applications, the loading chamber 202 can be charged to a pressure below the therapy pressure. In some embodiments, for example, the desired therapy pressure can be about -125 mm Hg and the pressure in the loading chamber 202 can be reduced to a pressure of about -150 mm Hg.
[049] If regulator valve 220 is calibrated for a particular therapy pressure and the control pressure 230 is greater than the therapy pressure, the spring force of regulator 22 6 must exceed the differential force, and the resulting force must act the regulator valve 220, moving the regulator valve 220 to an open position (see Figure 2B) in which stem 224 decouples from load port 205. Decoupling stem 224 from load port 205 can also be referred to as opening of the loading door 205. The pressure between the loading chamber 202 and the feeding chamber 204 can equalize through the opened loading door 205. As the loading chamber 202 and the feeding chamber 204 continue to equalize, the pressure in the feeding chamber 204 continues to decrease. Unless there is a complete blockage of the fluid path between the supply chamber 204 and the therapeutic environment, the pressure in the therapeutic environment also decreases and equalizes with the pressure in the supply chamber 204 through the supply lumen 216a. And unless there is a complete obstruction of the fluid path between the therapeutic environment and the control chamber 206, the control pressure 230 also decreases and equalizes with the pressure in the therapeutic environment through the feedback lumen 216b. As the control pressure 230
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24/61 decreases and approaches the therapy pressure, the differential force increases until it exceeds the spring force of regulator 226, causing the rod 224 to engage with the loading port 205. The coupling of the rod 224 with the loading port 205 can substantially reduce or prevent fluid communication between the loading chamber 202 and the feeding chamber 204 through the loading port 205, as shown in the illustrative embodiment of Figure 2A. The coupling of the rod 224 with the loading door 205 can also be referred to as closing the loading door 205. The loading door 205 is generally open until the control pressure 230 is lower or substantially equal to the therapy pressure. Advantageously, regulator valve 220 can keep loading port 205 open to compensate for pressure drops and partial blockages, particularly in the liquid path between the supply chamber 204 and a controlled environment, because the pressure in the controlled environment can be measured directly through the 216b feedback lumen.
[050] Figure 3A is a cross-sectional view illustrating a regulator 300 that can be associated with some embodiments of the reduced pressure therapy system 100. Regulator 300 is another exemplary embodiment of regulator 106. Regulator 300 can be similar to regulator 200 of Figures 2A-2B in many respects, and may include a housing 302 and a valve of regulator 326. Housing 302 can have a rear wall 303, one or more side walls 301 and an open end 305 opposite rear wall 303. Side walls 301 can be coupled to peripheral portions of, and generally perpendicular to, rear wall 303.
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[051] The packaging structure 302 can be partitioned by a first wall 304 and a second wall 306 to form a loading chamber 308, a feeding chamber 310 and a control chamber 312. In the illustrative embodiment, the loading chamber The load 308 can be adjacent to the feed chamber 310, arranged between the rear wall 303, the first wall 304 and the side walls 301. The feed chamber 310 can be arranged between the load chamber 308 and the feed chamber 312. For example, in Figure 3A, the first wall 304 separates the loading chamber 308 and the feeding chamber 310. The feeding chamber 310 can be bounded by the first wall 304, the side walls 301 and the second wall 306. The control chamber 312 can be adjacent to the feed chamber 310, as shown in the illustrative embodiment of Figure 3A. For example, the second wall 306 can separate the feed chamber 310 and the control chamber 312. The feed chamber 310 can be bounded by the second wall 306, the side walls 301 and the open end 305 of the housing 302. A the first wall 304 and the second wall 306 may be coupled to the side walls 301 of the packaging structure 302 in the peripheral portions of the first wall 304 and the second wall 306. In some embodiments, fluid communication cannot occur between the loading chamber 308 , the feed chamber 310 and the control chamber 312 in places where the first wall 304 and the second wall 306 couple to the packaging structure 302.
[052] The packaging structure 302, the first wall 304 and the second wall 306 can be formed of a material having sufficient strength to resist collapse when reduced pressure is applied.
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26/61 fed to the loading chamber 308, feeding chamber 310 and control chamber 312, such as metals, hard plastics or other suitable materials. For example, the packaging structure 302, the first wall 304, and the second wall 306 can resist collapse when a reduced pressure of about 150 mm Hg (-150 mm Hg gauge pressure) is fed to the loading chamber 308, feed chamber 310 or control chamber 312. In other exemplary embodiments, the packaging structure 302, the first wall 304, and the second wall 306 can withstand collapse when a reduced pressure of about 600 mm Hg (-600 mm Hg of pressure gauge) is fed to the loading chamber 308, feeding chamber 310 or control chamber 312.
[053] The charge chamber 308 may include a source port 314 and a charge port 316. The source port 314 may be arranged on one of the side walls 301 of the charge chamber 308 and may be fluidly coupled to the chamber load 308. In the illustrative embodiment, the source port 314 can be configured to be fluidly coupled to a reduced pressure supply, such as an electric pump, a hand pump or a wall suction source, for example. In some embodiments, the source port 314 may be fluidly coupled to a wall suction source by means of a conduit or tube. A one-way valve can be arranged on the source port 314 and oriented to prevent fluid flow into the charge chamber 308 through the source port 314 and allow fluid to exit the charge chamber 308 through the source port 314 .
[054] In some embodiments, the loading door 316 may be arranged on the first wall 304, as shown in the illustrative embodiment of Figure
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3Α. The loading door 316 can fluidly couple the loading chamber 308 and the feed chamber 310. In some embodiments, the loading door 316 may have a cylindrical wall 315 and a central passage 317 that extends between the chamber load 308 and the feed chamber 310. The cylindrical wall 315 may include a portion extending into the feed chamber 310 from the first wall 304 so that the load port 316 ends near a central portion of the second wall 306. In some embodiments, the loading door 316 may be arranged in other locations on the first wall 304.
[055] The feed chamber 310 can include a feed port 318 and a monitoring port 319. In the illustrative embodiments, the feed port 318 can be fluidly coupled to the feed chamber 310 and provide an interface for the feed chamber 310. For example, feed port 318 may be configured to be coupled to a tube, which may be coupled to a cover or other upstream component. A one-way valve can be arranged on the feed port 318 and oriented to allow fluid to flow into the load chamber 310 through the feed port 318 and prevent fluid from leaving the load chamber 310 through the feed port 318 .
[056] The monitoring port 319 can be fluidly coupled to the feed chamber 310, providing a second interface to the feed chamber 310. In some embodiments, for example, the monitoring port 319 can be arranged in a side walls 301, opposite the feed port 318. In other embodiments, the feed port
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The monitoring port 319 may be fluidly coupled to a monitoring device, such as a sensor, indicator or overpressure valve, for example. In some embodiments, the monitoring port 319 can be sealed so that no fluid communication occurs through the monitoring port 319.
[057] The control chamber 312 can include a control port 321 and a monitoring port 323. In the illustrative embodiment, the control port 321 can be fluidly coupled to the control chamber 312 and provide an interface for the control chamber 312. In some embodiments, control port 321 may be arranged on the same side of regulator 300 as supply port 318. In still other embodiments, control port 321 may be vertically aligned with the feed port 318. In the illustrative embodiment of Figure 3A, the control port 321 can be configured to be coupled to a tube, which can be coupled to a cover or other upstream component. A one-way valve can be arranged in the control port 321 and oriented to prevent the flow of fluid into the control chamber 312 through the control port 321 and allow the fluid to exit the control chamber 312 through the control port 321 .
[058] Monitoring port 323 may also be fluidly coupled to control chamber 312. In some embodiments, monitoring port 323 may be opposite control port 321. In other embodiments, the monitoring port The monitoring port 323 can be arranged on the same side of the regulator 300 as the control port 321. In other embodiments, the control port
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29/61 monitoring 323 may be vertically aligned with monitoring port 319. Monitoring port 323 may be fluidly coupled to a monitoring device, such as a sensor, indicator or overpressure valve, for example. In some embodiments, the monitoring port 323 can be sealed so that no fluid communication occurs through the monitoring port 323.
[059] The second wall 306 can include an opening 320 in a central portion near the distal end of the cargo door 316. As illustrated in Figure 3A, the opening 320 can be axially aligned with the central passage 317. The opening 320 can be greater than the distal end of the loading door 316, providing a gap between the peripheral portion of the opening 320 and the distal end of the loading door 316. The gap provides a fluid path between the loading chamber 316 and the feeding chamber 310 In some embodiments, the gap between the peripheral opening portion 320 and the distal end of the loading door 316 can be about 0.5 mm. In other embodiments, the gap between the peripheral portion of the opening 320 and the distal end of the loading door 316 may be less than 0.5 mm. In still other alternative or additional embodiments, the distal end of the loading door 316 can be vertically separated from the second wall 306. For example, the distal end of the loading door 316 can be vertically separated from a lower surface of the second wall 306. at a distance of about 0.5 mm. In other embodiments, the distance separating the distal end of the loading door 306 and the lower surface of the second wall 306 can be greater than 0.5 mm.
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[060] Regulator valve 326 can be operatively associated with charge port 316 to regulate fluid communication between charge chamber 308 and feed chamber 310. Regulator valve 326 can be set to open or close the charge door. load 316. In some embodiments, regulator valve 326 can be coupled to open end 305 of housing 302, as shown in Figure 3A. The regulator valve 326 can be coupled to the ends of the side walls 301 of the packaging structure 302, opposite the rear wall 303 of the packaging structure 302. In some embodiments, the regulator valve 326 can substantially limit or prevent fluid communication through the open end 305 of the housing structure 302. Regulator valve 32 6 can include valve member 322, valve body, such as stem 328 and actuator 330. Regulator valve 326 can also include a cap regulator 332, regulator spring 334, adjustment shaft 336 and tension adjuster, such as a push button, lever or disc 338.
[061] Figure 3B is a schematic sectional view of regulator 300 illustrating additional details that may be associated with some embodiments. In some embodiments, valve member 322 may be a flexible membrane, such as a diaphragm. In some embodiments, valve member 322 may be generally disk-shaped with a diameter greater than the diameter of opening 320 in second wall 306. In other embodiments, valve member 322 may have a corresponding shape to the shape of the opening 320, for example square, rectangular, ovoid, triangular or amorphous shapes. The valve member 322 may have
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31/61 peripheral portions coupled to the second wall 306, and the valve member 322 can extend along the opening 320. When the valve member 322 is coupled to the second wall 306, the valve member 322 can insulate in terms of fluids to control chamber 312 relative to feed chamber 310. For example, a difference in pressures in feed chamber 310 and control chamber 312 can cause deflection of valve member 322. In some embodiments, the valve member 322 can be made of a silicone material. In some embodiments, valve member 322 can have a hardness rating between about 30 Shore A and about 50 Shore A.
[062] As shown in Figure 3B, some embodiments of the loading port 316 may have a valve seat 324 at the distal end. The valve seat 324 can provide a tapered or beveled edge near the central passage 317 of the cargo port 316. In some embodiments, the valve member 322 may include an enlarged portion 325 configured to couple with the valve seat 324. For example, valve member 322 can be positioned so that enlarged portion 325 of valve member 322 can engage with a bevelled edge of valve seat 324 of cargo port 316 in a closed position. If coupled in such a way, it can substantially prevent fluid communication through passage 317 of cargo port 316.
[063] The stem 328 can be cylindrical and have an end coupled to the valve member 322. In some embodiments, a first end of the stem 328 can be coupled to the enlarged portion 325 of the valve member 322. The stem 328 is elongated so that stem 328 can extend through open end 305 when the
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32/61 end of stem 328 is coupled to valve member 322. A second end of stem 328 can include a cavity 340. Cavity 340 can be a recess into the stem 328 of a second end of stem 328. The cavity 340 may have a diameter less than the diameter of the stem 328 so that a shoulder 349 can form at the end of the stem 328 adjacent to an opening in the cavity 340. The shoulder 349 may face the opposite side of the housing structure 302 The stem 328 may also have a recess 333 disposed between ends of the stem 328. In some embodiments, the recess 333 is annular and may be disposed near a center of a length of the stem 328.
[064] The actuator 330 can be coupled to the housing structure 302 so that the actuator 330 covers the open end 305. In some embodiments, the actuator 330 extends along the open end 305 to isolate in terms of fluids the control chamber 312 in relation to the surrounding environment. In some embodiments, the actuator 330 may be a diaphragm having peripheral portions coupled to the ends of the side walls 301 of the housing structure 302. The actuator 330 may have an elasticity allowing a central portion of the actuator 330 to deflect from an equilibrium position while the peripheral portions of the actuator 330 remain attached to the housing structure 302. In some embodiments, the actuator 330 can be made of an elastomeric material. For example, actuator 330 can be made of silicone. In some embodiments, actuator 330 may be made of a material having a hardness rating between about 30 Shore A and about 50 Shore A.
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[065] Actuator 330 may have an opening 331 near a central portion of actuator 330. Opening 331 can receive stem 328 so that stem 328 extends through actuator 330. In some embodiments, actuator 330 can be coupled or otherwise sealed with stem 328. For example, actuator 330 can be welded to stem 328 in opening 331. For example, at least a portion of actuator 330 adjacent to opening 331 can be inserted into recess 333 to couple actuator 330 to stem 328. In some embodiments, movement of stem 328 along an axis of stem 328 causes movement of the central portion of actuator 330, and movement of actuator 330 along an axis of stem 328 can cause stem movement 328.
[066] When assembled, as shown in Figure 3A, the regulator cover 332 can be attached to the housing structure 302 so that the regulator cover 332 is adjacent to the control chamber 312 and the open end 305. In the embodiments For example, regulator cover 332 covers open end 305 of housing 302 and includes a raised portion extending away from control chamber 312 near a center of regulator cover 332. In some embodiments, the portion The rise can be coextensive with the open end 305 so that the regulator cover 332 can be separated from the actuator 330 near the open end 305. The stem 328 can extend through the raised portion of the regulator cover 332. The regulator cover 332 can be sealed with stem 328. In some embodiments, stem 328 can move relative to regulator cover 332 while remaining sealed with regulator cover 332. In In other embodiments, stem 328 may not be sealed
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34/61 fluidly with regulator cover 332, so that an ambient pressure adjacent to an exterior of regulator cover 332 can be substantially equivalent to a pressure in the area between the raised portion of regulator cover 332 and actuator 330.
[067] Regulator spring 334 can be arranged on stem 328 so that regulator spring 334 circumscribes stem 328. Regulator spring 334 can have a first end adjacent to regulator cover 332. In some embodiments, the first end of the regulator spring 334 can contact the regulator cover 332 so that the regulator spring 334 can be compressed against the regulator cover 332. The second end of the regulator spring 334 can be adjacent to the end of the stem 328 that it has cavity 340 arranged therein. Regulator spring 334 can have a length Y in a relaxed position, as shown in Figure 3B. In the relaxed position, regulator spring 334 may not be expanded or compressed so that regulator spring 334 does not exert a spring force. In some embodiments, a length Y1 can be the length of the regulator spring 334 in a compressed position, as shown in Figure 3A, for example if the regulator valve 326 blocks fluid communication through the charge port 316.
[068] The adjustment shaft 336 may have an end disposed within the cavity 340 and may be coupled to the stem 328 so that the adjustment shaft 336 and the stem 328 can move as integral members. The adjustment shaft 336 can be cylindrical and have an enlarged distal end forming an adjustment cap 337 of the adjustment shaft 336. A portion of the adjustment shaft 336 can be threaded between the
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35/61 adjustment 337 and the end disposed within cavity 340. In some embodiments, adjustment shaft 336 can be threaded between adjustment cap 337 and an opening in cavity 340 of stem 328.
[069] Disc 338 may be a tubular body having a first portion 339 and a second portion 341. The first portion 339 may have a cavity 345, and the cavity 345 has a width or diameter substantially equal to the outer diameter of the threaded portion of the adjusting shaft 336. The second portion 341 can also have a cavity 347, the width or diameter of the cavity 347 can be substantially equal to the outer diameter of the stem 328. The first portion 339 and the second portion 341 are preferably joined together in the shapes illustrative embodiments of Figure 3A, forming a shoulder 343 between the cavity 345 and the cavity 347. The disc 330 can be arranged on the stem 328 so that the shoulder 343 faces the cavity 340. As shown in the illustrative embodiment of the 3A, the shoulder 343 can have an annular width substantially equal to the width of a member 349 of the stem 328 formed by the cavity 340. The disk 338 can be movably coupled to the adjustment shaft o 336 near adjustment cap 337 of adjustment shaft 336. In some embodiments, the first portion 339 of disc 338 is adjacent to adjustment cap 337 of adjustment shaft 336. In some embodiments, the surface of the cavity 345 of the first portion 339 can be threaded. The disk 338 can be threaded with the adjustment shaft 336, allowing the disk 338 to be rotated over the adjustment shaft 336. Rotating the disk 338 over the adjustment shaft 336 can cause the disk 338 to move parallel to a adjustment shaft axis
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336. In this way, disk 338 can be moved along adjustment shaft 336.
[070] Figure 3C is a schematic sectional view of regulator 300 illustrating additional details that may be associated with some embodiments of regulator 300 in an open position. The disk 338 can be positioned on the adjusting shaft 336 so that one end of the second portion 341 of the disk 338 contacts the distal end of the regulator spring 334. For example, the disk 338 can be threaded on the adjustment shaft 336, and the additional rotation of disk 338 relative to adjusting shaft 336 can move disk 338 axially closer to regulator cover 332 to compress regulator spring 334. Compression of regulator spring 334 by disk 338 shortens the length of regulator spring 334 This compression can cause the regulator spring 334 to exert a force on the disk 338 by pushing the disk 338 away from the regulator cover 332. In some embodiments, the regulator spring 334 can have a length Y2 if the spring of the regulator regulator 334 is compressed by disk 338. The force exerted by the regulator spring 334 is directly proportional to the displacement of the regulator spring 334 from the relaxed position. The force exerted by the regulator spring 334 on disk 338 pushes upwardly the adjusting shaft 336, the stem 328 coupled, and the valve member 322 coupled in a similar manner. In the illustrative embodiment, the force also pushes the valve member 322 away from the loading port 316 to an open position. In the open position, fluid communication through cargo port 316 can occur.
[071] A differential force can also operate on actuator 330. The differential force can be a force generated by a difference in pressure between the pressure chamber
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37/61 control 312 and the environment surrounding regulator 300. The pressure in the control chamber 312 can also be referred to as a control pressure. If the control pressure in the control chamber 312 and the pressure in the surrounding environment are substantially equal, the differential force can be approximately zero. If the control pressure in the control chamber 312 is less than the ambient pressure, for example, if regulator 300 is being used to provide reduced pressure therapy, the differential force can act to push actuator 330, stem 328 coupled and the valve member 322 towards the distal end of the loading port 316.
[072] If the differential force is greater than the spring force of regulator 334 acting on stem 328, valve member 322 can be pushed to contact the distal end of the cargo port 316 to prevent fluid communication through the cargo port 316 in a closed position, as shown in Figure 3A. If the differential force is less than the spring force on regulator spring 334, valve member 322 can be pushed away from the distal end of the charge port 316 to allow fluid communication through the charge port 316 in the open position, as shown in Figure 3C. Disc 338 can be threaded down on adjusting shaft 336 to control the spring compression of regulator 334 from the relaxed length Y. Thus, the compression of the spring of regulator 334 can be controlled to select a prescribed therapy, so that spring force of regulator 334 can be exceeded when the therapy pressure is reached in the control chamber 312.
[073] In other embodiments, a differential force can act on valve member 322. For example, the supply pressure in the supply chamber
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310 can exert a force on the valve member 322, and the control pressure in the control chamber 312 can exert a force on the valve member 322. The sum of forces acting on the valve member 322 can be referred to as a valve force. The valve force can push the valve member 322 to contact or to stop being in contact with the loading port 316. In some embodiments, the valve force can act in opposition to the differential force acting on the actuator 330 . The relative dimensions of valve member 322 and actuator 330 can be selected so that actuator 330 is several times larger than valve member 322. For example, actuator 330 may have a larger dimension that is greater than one dimension corresponding valve member 322. In some embodiments, actuator 330 may have a diameter that is greater than a diameter of valve member 322. A large difference in size between actuator 330 and valve member 322 correlates with an identically large difference in the surface areas of actuator 330 and valve member 322. The larger surface area of actuator 330 allows the differential force acting on actuator 330 to act on an area greater than the valve force acting on valve member 322. As a result, the differential force acting on actuator 330 may exceed other forces acting on other components of regulator 300, such as valve member 3 22, allowing the actuator 330 to control the movement of the stem 328. In some embodiments, the opening 320 can be made smaller than shown, and the loading door 316 can be further separated from the lower surface of the second wall 306. In in such an embodiment, the valve member 322 can be made relatively smaller so that the force
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39/61 valve acts on a surface area less than the differential force.
REDUCED PRESSURE THERAPY SYSTEM
[074] Figure 4 is a schematic illustration of a reduced pressure system 400 illustrating additional details that may be associated with the operation of regulator 300. The reduced pressure system 400 is an exemplary embodiment of the reduced pressure system 100. The reduced pressure system 400 includes a reduced pressure source 402, a container 403 and a cover 404. The reduced pressure source 402 can be a wall suction source, a hand pump or an electric pump, for example. In the illustrative embodiment, the reduced pressure source 402 can be a wall suction source and can be fluidly coupled to the source port 314. For example, a tube can fluidly couple the reduced pressure source 402 to the source port. source port 314, as shown in the illustrative embodiment of Figure 4. Container 403 is an exemplary embodiment of container 112, and can be fluidly coupled to feed port 318. In some embodiments, for example , a tube 410 can fluidly couple container 403 to feed port 318. Container 403 may include a filter, such as a hydrophobic filter 414 adjacent to one end of tube 410. Cover 404 is an exemplary embodiment of cover 102, and can be fluidly coupled to container 403. For example, a tube 412 can fluidly couple cover 404 to container 403. Cover 404 can have a pressure that can also be referred to as a collector pressure. In some embodiments, tube 410 and tube 412 may each have at least one lumen. At least one lumen in tube 410 and tube 412 can be
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40/61 collectively referred to as a feeding lumen. In other embodiments, container 403 may be omitted, and tube 410 may be coupled directly to cover 404. In these embodiments, the at least one lumen in tube 410 may be considered a feed lumen. The cover 404 can also be fluidly coupled to the control port 321. For example, a tube 408 can fluidly couple the cover 404 to the control port 321. In some embodiments, the tube 408 can have at least one lumen. The at least one lumen of tube 408 can also be referred to as a feedback lumen.
[075] The cover 404 can be fluidly coupled to the feed port 318 and the control port 321 so that fluid communication can occur between the feed chamber 310 and the cover 404 through the container 403, and between the cover 404 and the control chamber 312. Fluid communication between the cover 404, the feed chamber 310 and the control chamber 312 can equalize the pressures in the feed chamber 310, the cover 404 and the control chamber 312. For example, the fluid communication between the cover 404, the feed chamber 310 and the control chamber 312 can equalize the supply pressure in the feed chamber 310, the pressure of the collector in the cover 404, and the control pressure in the control chamber 312. If the source port 314 is not coupled to the reduced pressure source 402, the charge port 316 may remain open and the ambient pressure may equalize between the charge chamber 308, the feed chamber 310, the cover 404 and the chamber control area 312.
[076] The reduced pressure source 402 can be coupled to the source port 314, providing reduced pressure to the loading chamber 308. If the regulator valve
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326 is in the open position, the loading door 316 provides a fluid path between the loading chamber 308 and the feeding chamber 310. As the reduced pressure supply reduces the pressure inside the loading chamber 308, the pressure in the feed chamber 310 may descend in a similar manner. The pressure in the supply chamber 310 can also be referred to as a supply pressure. Fluid communication through the feed port 318 will similarly reduce the pressure in the cover 404, and fluid communication through the control port 321 may similarly start to lower the pressure in the control chamber 312. As the control pressure in control chamber 312 goes down, the differential force acting in opposition to the spring force of regulator 334 will increase, eventually exceeding the spring force of regulator 334, causing stem 328 to move downward and forcing the valve regulator 326 to the closed position in which the valve member 322 rests on the loading port 316. In the closed position, the valve member 322 can block fluid communication through the loading port 316. Reduced pressure reductions in the cover 404 can reduce the differential force, so that the influence force of the regulator spring 334 exceeds the differential force to open the regulator valve 326. In the open position, the co Fluid communication through the loading port 316 can be resumed until the pressure in the cover 404, and in turn in the control chamber 312, drops enough to pass the regulator spring 334, closing the regulator valve 326 again.
[077] Repeated opening and closing of regulator valve 326 can occur while reduced pressure therapy is provided.
FEEDBACK SYSTEMS
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[078] Figure 5 is a schematic view illustrating an exemplary embodiment of a feedback system 500 that can be used with some embodiments of the reduced pressure therapy system 400. In Figure 5, for example, the feedback is illustrated with an exemplary embodiment of regulator 300. In some embodiments, feedback system 500 may include a printed circuit board 502 having a pressure sensor 504 disposed therein. The printed circuit board 502 can be an electronic device having one or more electronic components communicatively coupled by conductive pathways 503. Generally, printed circuit boards can be formed from conductive and non-conductive laminar sheets that are chemically machined to create communicative couplings . Printed circuit boards can also include additional electronic components such as capacitors, resistors or other active devices. In some embodiments, the printed circuit board 502 may include a power supply or source of electrical potential, such as a battery 506, and a signal or indicator interface. In some embodiments, the signal interface may be a visual device, such as a light-emitting diode (LED) 508, an acoustic device, such as a loudspeaker or emitter, a tactile device, such as a mobile protrusion or an olfactory device. The printed circuit board 502 may further include an electronic storage device, such as a memory, a processing unit and other devices configured to operate the feedback system 500.
[079] The 504 pressure sensor can be an electronic device communicatively coupled to the
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43/61 printed circuit board 502, LED 508 and battery 506. In some embodiments, the pressure sensor 504 can be a piezoresistive strain gauge, a capacitive sensor, an electromagnetic sensor, a piezoelectric sensor, an optical sensor, or a potentiometric sensor, for example. The pressure sensor 504 can measure a voltage caused by an applied pressure. The pressure sensor 504 can be calibrated by relating a known amount of voltage to a known applied pressure. The known ratio can be used to determine an unknown applied pressure based on a measured amount of stress. In some embodiments, the pressure sensor 504 may include a receptacle configured to receive an applied pressure. In the illustrated embodiment, the pressure sensor 504 can be fluidly coupled to the monitoring port 323 of regulator 300 by a tube 510.
[080] LED 508 can be a semiconductor light source that includes a chi of semiconductor material that is doped with impurities to create a p-n junction. Current can be supplied to the p-n junction, causing electrons to move along the junction and release energy in the form of a photon. The photon can comprise visible light with a particular wavelength. The wavelength of the photons emitted by LED 508 can be selected during the production of LED 508 so that LED 508 can emit a desired color of light. In some embodiments, LED 508 can be formed on printed circuit board 502. In other embodiments, LED 508 can be formed independently and later communicatively coupled to printed circuit board 502. LED 508 can communicatively coupled to the
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44/61 pressure 504 to receive a signal from the pressure sensor 504 in response to an applied pressure.
[081] Battery 506 can be a single cell voltage source that can be coupled to printed circuit board 502. In some embodiments, battery 506 can be replaceable. In other embodiments, the battery 506 can be rechargeable and configured to receive a current or voltage from an external source. The 506 battery can also be connected communicatively to LED 508 and pressure sensor 504 to supply current to LED 508 and pressure sensor 504 for its operation.
[082] In operation, the feedback system 500 can be fluidly coupled to regulator 300 to determine pressures in regulator 300 chambers and indicate an operating state of regulator 300 in response. In some embodiments, the operating state of regulator 300 may include a current pressure, a pressure differential, a leakage condition, a blocking condition, a full vessel condition or an overpressure condition, for example.
[083] In some embodiments, pressure sensor 504 can be fluidly coupled to control chamber 312. For example, pressure sensor 504 can be fluidly coupled to tube 510 which can be fluidly coupled to the monitoring port 323. A reduced pressure can be supplied to the loading chamber 308, and the regulator 300 can operate as described above to control the delivery of the reduced pressure therapy. The control pressure in the control chamber 312 can be fluidly coupled to the pressure sensor 504 through the tube 510. The pressure sensor 504 can determine an amount of tension caused by the control pressure
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45/61 applied to pressure sensor 504 through tube 510. Pressure sensor 504 can determine a control pressure value based on the measured voltage.
[084] The feedback system 500 can provide a signal for one or more operating states. For example, the feedback system 500 can provide a generic alarm for a leak condition, a block condition or a full container condition. In another example, the feedback system 500 can illuminate LED 508 if pressure sensor 504 measures a control pressure within a therapeutic range of therapy pressure. In some embodiments, the therapy pressure can be a pressure of about -120 mm Hg, for example, and the therapeutic range can have a tolerance of about 10 mm Hg or less than the therapy pressure. As used herein, a pressure exceeding an upper limit of the therapeutic range refers to a reduced pressure that is greater than the therapeutic range. For example, if the therapy pressure is -120 mm Hg, the upper limit of the therapeutic range is -130 mm Hg, and a reduced pressure of -131 mm Hg would exceed the upper limit of the therapeutic range. Similarly, a pressure exceeding a lower limit of the therapeutic range refers to a reduced pressure that is less than the therapeutic range. For example, if the therapy pressure is -120 mm Hg, the lower limit of the therapeutic range is -110 mm Hg, and a reduced pressure of -109 mm Hg would exceed the lower limit of the therapeutic range.
[085] In some embodiments, if the control pressure determined by the 504 pressure sensor is within the therapeutic range of the therapy pressure, a signal can be communicated to LED 508, causing LED 508 to light up. The lighting of LED 508 can
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46/61 continue as long as the control pressure in the control chamber 312 is within the therapeutic range. If the control pressure in the control chamber 312 exceeds the upper or lower limit of the therapeutic range, the feedback system 500 may stop illuminating LED 508. In this way, the feedback system 500 can signal that an operating state of the reduced pressure therapy system 400 is an application of therapy pressure.
[086] In some embodiments, if the pressure communicated to the pressure sensor 504 via tube 510 is within the therapeutic range of the therapy pressure, the pressure sensor 504 can generate a signal that completes an electrical circuit on the circuit board printed 502. The completion of the electrical circuit can supply current to LED 508, causing LED 508 to illuminate. In other embodiments, if the pressure communicated to the pressure sensor 504 through the tube 510 is within the therapeutic range of the therapy pressure, the pressure sensor 504 can generate a signal that interrupts an electrical circuit on the printed circuit board 502. In this embodiment, interrupting the circuit can prevent the current from reaching LED 508, causing LED 508, which may have been illuminated, to stop illuminating.
[087] In some embodiments, the therapy pressure can be selected during the production of the feedback system 500. For example, the therapy pressure can be wired to the printed circuit board 502. In other embodiments, the printed circuit board 502 may include a controller or central processing unit having the therapy pressure programmed into the controller or central processing unit. In other embodiments, the system of
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47/61 feedback 500 can include an insertion device, such as a switch, a dial or keyboard, for example, which can allow an operator to enter the therapy pressure.
[088] In still other embodiments, LED 508 may be able to illuminate at various wavelengths so that different colors can be illuminated in response to different control pressures determined by the 504 pressure sensor. In these embodiments , colors can be coordinated to a particular control pressure determined by the pressure sensor 504 so that LED 508 can provide a wider range of information in addition to whether or not the control pressure is within the therapeutic range of the therapy pressure . In some embodiments, LED 508 may include several LEDs, such as a green LED, a blue LED and a red LED. For example, the feedback system 500 can illuminate a red LED if the control pressure determined by the pressure sensor 504 exceeds the upper limit of the therapeutic range of the therapy pressure, indicating an overpressure condition. The feedback system 500 can illuminate a blue LED if the pressure determined by the pressure sensor 504 exceeds a lower limit of the therapeutic range of the therapy pressure, indicating a leakage condition. The feedback system 500 can illuminate a green LED if the pressure determined by the pressure sensor 504 is within the therapeutic range of the therapy pressure, indicating an application of reduced pressure therapy. In other embodiments, LED 508 may be able to selectively emit light having a blue tone, a red tone, a green tone or other colors.
[089] In still other embodiments, regulator 300 may include a potentiometer 512 coupled with
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48/61 communicative form to adjustment shaft 336 and disk 338. Potentiometer 512 can be a resistor with three terminals, for example, with a sliding contact that forms an adjustable voltage divider. Potentiometer 512 can supply a variable voltage in response to the operation of the sliding contact. In some embodiments, potentiometer 512 can be calibrated to provide a voltage signal that corresponds to the axial position of disk 338 relative to adjustment shaft 336. When disk 338 is displaced relative to adjustment shaft 336, the voltage signal supplied by potentiometer 512 may change. In some embodiments, the voltage signal provided by potentiometer 512 may be related to the therapy pressure. In these embodiments, potentiometer 512 can also be communicatively coupled to printed circuit board 502. The voltage signal received by the printed circuit board 502 can be recorded as the therapy pressure so that the feedback system 500 can adjust an operation of LED 508 in response to a change in therapy pressure. For example, if the disk 338 is positioned so that a therapy pressure of about 120 mm Hg can be desired, the voltage signal communicated to the printed circuit board 502 can cause the feedback system 500 to adjust the operation of the LED 508 so that LED 508 cannot illuminate until pressure sensor 504 determines that a control pressure of about -120 mm Hg has been communicated through tube 510. If disk 338 is then positioned so that it can be a therapy pressure of -110 mm Hg is desired, the voltage signal communicated to the printed circuit board 502 by potentiometer 512 may cause the feedback system 500 to adjust the operation of LED 508 so that LED 508 does not
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49/61 can illuminate until pressure sensor 504 determines that a control pressure of about -110 mm Hg has been communicated through tube 510.
[090] In some embodiments, the printed circuit board 502 may include an on / off button that can selectively supply voltage or potential to the printed circuit board 502. In some embodiments, the on / off button may be an electrical switch that, if turned on, interrupts a circuit on the printed circuit board 502. In other embodiments, the on / off button can take the form of a pull tab positioned between the battery 506 and a contact terminal on the board printed circuit board 502. If the pull tab is removed, a circuit on printed circuit board 502 can be completed via battery 506.
[091] The printed circuit board 502 may also include a speaker communicatively coupled to the printed circuit board 502 and the battery 506. In these embodiments, the signal can be an audible alarm. If the pressure changes by a predetermined amount, the printed circuit board 502 can supply the speaker with a current to cause the speaker to provide an audible alarm. In some embodiments, the printed circuit board 502 may include an audio pause button. The audio pause button may allow you to mute the audio capability of the printed circuit board 502.
[092] In other embodiments, feedback system 500 can be used with regulator 200. For example, pressure sensor 504 can be fluidly coupled to control chamber 206 of regulator 200. In some embodiments , the 504 pressure sensor can
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50/61 is fluidly coupled to the T 215 connector. The T 215 connector can provide fluid communication between the pressure sensor 504 and the control chamber 206. The feedback system 500 can operate with regulator 200 as described above in relation to regulator 300.
[093] Figure 6 is a schematic view illustrating additional details of another exemplary embodiment of a feedback system 600 that can be used with some embodiments of the reduced pressure therapy system 400. In Figure 6, for example , feedback system 600 is illustrated with an exemplary embodiment of regulator 300. Feedback system 600 may include a printed circuit board 602 having a control pressure sensor 604 and a supply pressure sensor 614 arranged therein. Printed circuit board 602 can be similar to printed circuit board 502 of Figure 5 in many aspects, and can include conductive pathways 603 communicatively coupling electrical components as described above. In the illustrative embodiment of Figure 6, the printed circuit board 602 can also include a power supply or source of electrical potential, such as a battery 606, and a signal or indicator interface, such as a liquid crystal display ( LCD) 608. In some embodiments, the signal interface may be a visual device, such as a light or the like, an acoustic device, such as a speaker or sound emitter, a tactile device, such as a protrusion mobile, or an olfactory device. The printed circuit board 602 may further include an electronic storage device, such as a memory, a processing unit and other devices configured to operate the feedback system 600.
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51/61
[094] The control pressure sensor 604 can be an electronic device communicatively coupled to the printed circuit board 602, the LCD 608 and the battery 606. The control pressure sensor 604 can be similar to and operate as described above in relation to the pressure sensor 504 of Figure 5. In the illustrated embodiment of Figure 6, the pressure control sensor 604 can be fluidly coupled to the monitoring port 323 of regulator 300 by a tube 610.
[095] Feed pressure sensor 614 can be an electronic device communicatively coupled to printed circuit board 602, LCD 608 and battery 606. Feed pressure sensor 614 can be similar to and operate as described above with respect to the pressure sensor 504 of Figure 5. In the illustrated embodiment of Figure 6, the supply control sensor 614 can be fluidly coupled to the monitoring port 319 of regulator 300 by a tube 616.
[096] Battery 606 can be similar to and operate as described above in relation to battery 506 in Figure 5. In the illustrative embodiment of Figure 6, battery 606 is still communicatively coupled to LCD 608, to the pressure sensor control panel 604 and the supply pressure sensor 614 to supply electrical power to the LCD 608 and control pressure sensor 604 for operation.
[097] The LCD 608 can be a screen that displays images using the light modulating properties of liquid crystals. In general, an LCD includes a layer of molecules aligned between two electrodes and two polarizing filters. Each filter has a transmission shaft that is perpendicular to the other so that when one filter is transparent, the other is not. A tension can be
Petition 870160017906, of 05/05/2016, p. 55/145
52/61 applied to the electrodes, and in response the layer molecules are aligned to block or allow light to pass through. An image is visible if the light is blocked. The LCD 608 can be communicatively coupled to the control pressure sensor 604 to receive a signal from the control pressure sensor 604. In some embodiments, the LCD 608 can signal operating states and other information, such as current pressure, pressure differential, a leakage condition, a blocking condition, an overpressure condition or a full vessel condition, for example. In some embodiments, the LCD 608 may display this information in the form of text or Arabic numerals, for example.
[098] In some embodiments, regulator 300 may include a potentiometer 612 communicatively coupled to the adjusting shaft 336 and disk 338. In these embodiments, potentiometer 612 can also be communicatively coupled to the control plate printed circuit 602 so that at least potentiometer 612 can transmit a voltage signal to printed circuit board 602. Potentiometer 612 can be similar to and operate as described above in relation to potentiometer 512 of Figure 5.
[099] In operation, feedback system 600 can be fluidly coupled to regulator 300 to determine pressures in regulator chambers 300 and, in response, signal an operating state of the reduced pressure therapy system 400. In some forms of embodiment, for example, the operating state of the reduced pressure system 400 may include a current pressure, a pressure differential, a leakage condition, a blocking condition, a full vessel condition or an overpressure condition.
Petition 870160017906, of 05/05/2016, p. 56/145
53/61
[0100] In some embodiments, the control pressure sensor 604 may be fluidly coupled to the control chamber 312, and the supply pressure sensor 614 may be fluidly coupled to the feed chamber 310. Pressure control in the control chamber 312 can be in fluid communication with the control pressure sensor 604 through the tube 610, and the supply pressure in the feed chamber 310 can be in fluid communication with the supply pressure sensor 614 through the tube 616. A reduced pressure can be supplied to the loading chamber 308 and the regulator 300 can operate substantially as described above to provide reduced pressure therapy. The control pressure sensor 604 can determine an amount of voltage caused by the control pressure applied to the control pressure sensor 604 through tube 610. The control pressure sensor 604 can determine a value of the control pressure in response to the quantity measured voltage. Similarly, the supply pressure sensor 614 can determine an amount of voltage caused by the supply pressure applied to the supply pressure sensor 614 through the tube 616. The supply pressure sensor 614 can determine a supply pressure value in response to the amount of voltage measured.
[0101] In some embodiments, when the cover is provided with reduced pressure, the manifold pressure can shift from ambient pressure to the supply pressure. The changed pressure can be in fluid communication with the control pressure sensor 604 through the control chamber 312 and the tube 610. The control pressure sensor 604 can generate a signal corresponding to the determined control pressure determined
Petition 870160017906, of 05/05/2016, p. 57/145
54/61 by the control pressure sensor 604. In response, the feedback system 600 can operate the LCD 608 to display a numerical value of the control pressure corresponding to the control pressure determined by the control pressure sensor 604. In some ways the numerical value may change when the control pressure changes.
[0102] The feedback system 600 can provide additional information regarding the provision of reduced pressure therapy using the LCD 608, the supply pressure sensor 614 and the control pressure sensor 604. In some embodiments, the plate printed circuit board 602 can include circuits or other components configured to monitor a difference between the control pressure determined by the control pressure sensor 604 and the supply pressure determined by the supply pressure sensor 614. For example, when a cover can be first applied to a tissue site, regulator 300 can be used in a reduction process. In the reduction process, the pressure in the cover, the pressure of the collector, is reduced from an ambient pressure to the supply pressure. The feedback system 600 can monitor the control pressure sensor 604 and the supply pressure sensor 614 to determine whether the reduction process is taking place within the desired parameters. In some embodiments, the feedback system 600 can determine the difference between the control pressure determined by the control pressure sensor 604 and a supply pressure determined by the supply pressure sensor 614 and display the pressure difference or differential of pressure on the LCD 608. In this way, the feedback system 600 can signal an operative state of the coverage reduction.
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55/61
[0103] In some embodiments, if the control pressure is within the therapeutic range of the therapy pressure, the feedback system 600 can continue to monitor the control pressure determined by the 604 control pressure sensor and the supply pressure determined by the supply pressure sensor 614. If the feedback system 600 determines that the control pressure determined by the control pressure sensor 604 exceeds the lower limit of the therapeutic pressure range of the therapy pressure, and the supply pressure determined by the supply pressure sensor 614 is within the therapeutic range of the therapy pressure, then feedback system 600 can display on LCD 608 that a leak condition has occurred. For example, the reduced pressure therapy system 400 may be leaking between supply port 318 and control port 321. Similarly, if control pressure sensor 604 and supply pressure sensor 614 determine both that the control pressure and the supply pressure, respectively, exceed the lower limit of the therapeutic range of the therapy pressure, so the feedback system 600 can display on the 608 LCD that a leak condition has occurred. For example, the reduced pressure therapy system may be leaking between the reduced pressure source 402 and the source port 314.
[0104] In some embodiments, if the feedback system 600 determines that the control pressure determined by the control pressure sensor 604 remains static while the supply pressure determined by the supply pressure sensor 614 changes, such as increase or pressure reduction, feedback system 600 can display on LCD 608 that a
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56/61 blocking condition. For example, the supply pressure sensor 614 can determine that the supply pressure exceeds the upper limit of the therapeutic range of the therapy pressure. If the control pressure sensor 604 determines that the control pressure remains within the therapeutic range of the therapy pressure, the feedback system 600 can display on LCD 608 that the operating state of the reduced pressure therapy system 400 is a condition of block.
[0105] In some embodiments, feedback system 600 can determine whether a full container condition has occurred. For example, if the supply pressure sensor 614 determines that the supply pressure has undergone an increase in the reduced pressure for a preset time that exceeds a preset tolerance, and the control pressure sensor 604 determines that the control pressure in the control chamber control 312 remains static, feedback system 600 can display on LCD 608 that a full container condition has occurred.
[0106] The printed circuit board 602 may also include circuits or devices configured to track the pressure level supplied over a period of time. By tracking the pressure level over a period of time, the feedback system 600 can determine how a pressure in a particular chamber, such as the control pressure in the control chamber 312, for example, changes during application. reduced pressure therapy. In some embodiments, the feedback system 600 may also include circuits, devices or software to show that pressures are changing over time on LCD 608.
[0107] The feedback system 600 can also determine a pressure differential between a pressure of
Petition 870160017906, of 05/05/2016, p. 60/145
57/61 collector in a cover and a pressure supplied to regulator 300 to provide an indication of the efficiency of the system. For example, the feedback system 600 can determine the supply pressure in the feed chamber 310 with the feed pressure sensor 614. The feedback system 600 can also determine the control pressure in the control chamber 312 with the pressure sensor. control system 604. The feedback system 600 can then determine the difference between the determined pressures and display the pressure differential on the LCD 608.
[0108] The feedback system 600 can also determine when an overpressure condition has occurred. For example, the feedback system 600 can determine the supply pressure in the feed chamber 310 with the feed pressure sensor 614. The feedback system 600 can also determine the control pressure in the control chamber 312 with the pressure sensor. control pressure 604. If the supply pressure determined by the supply pressure sensor 614 and the control pressure determined by the control pressure sensor 604 exceed the upper limit of the therapeutic range of the therapy pressure, the feedback system 600 may indicate that an overpressure condition has occurred. An overpressure condition may be caused in part by a failure of regulator 300 allowing excess reduced pressure to be provided to the cover.
[0109] In some embodiments, the therapy pressure can be selected during the production of the feedback system 600. For example, the therapy pressure can be wired to the printed circuit board 602. In other embodiments, printed circuit board 602 may include a controller or central processing unit having therapy pressure
Petition 870160017906, of 05/05/2016, p. 61/145
58/61 programmed in the controller or central processing unit. In other embodiments, the feedback system 600 may include an insertion device, such as a switch, a disk or keyboard, for example, which can allow an operator to enter the therapy pressure. In still other embodiments, feedback system 600 can receive a signal from potentiometer 612 that feedback system 600 can use to determine therapy pressure.
[0110] In other embodiments, feedback system 600 can be used with regulator 200. For example, control pressure sensor 604 can be fluidly coupled to control chamber 206 of regulator 200. In some ways the control pressure sensor 604 can be fluidly coupled to the T 215 connector. The T 215 connector can provide fluid communication between the control pressure sensor 604 and the control chamber 206. The pressure sensor supply 614 may be fluidly coupled to supply chamber 204 of regulator 200. In some embodiments, supply pressure sensor 614 may be fluidly coupled to the T-217 connector. The T-217 connector can provide fluid communication between the supply pressure sensor 614 and the supply chamber 204. The feedback system 600 can operate with regulator 200 as described above in relation to regulator 300.
[0111] In some embodiments, regulator 200 may include monitoring ports similar to monitoring ports 319 and monitoring port 323 of regulator 300. Similarly, regulator 300 may include T connectors similar to the T connector 215 and the T 217 connector of regulator 200. The
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59/61 monitoring ports and T connectors can be coupled in a similar way to the respective regulators and operate in a similar way.
[0112] In some embodiments, the pressures measured by the feedback system 500 and the feedback system 600 can be monitored during a static time period or a rotating time period. A static period of time can refer to a period of time in which pressure is monitored during an isolated period of time. For example, the feedback system 500 or feedback system 600 can monitor a pressure measured for thirty seconds. When the time period ends, monitoring ends. A rotating period of time can refer to a period of time in which the pressure is monitored over a continuous period of time. For example, the feedback system 500 or feedback system 600 can monitor a pressure measured for thirty seconds. When the time period ends, monitoring starts again. In some embodiments, monitoring can compare the pressures measured over various time periods.
[0113] In some embodiments, the feedback system 500 and feedback system 600 may include wireless communication technologies, such as radio frequency identification (RFID) to provide operators with a method of retrieving therapy data such as such as duration of therapy, pressures and alarm conditions. In some embodiments, a secondary regulator can be positioned in line between a reduced pressure source and regulator 300 to purge blockages. A secondary regulator may include a release mechanism allowing the secondary regulator to flood the loading chamber 308 with higher pressure in an attempt to
Petition 870160017906, of 05/05/2016, p. 63/145
60/61 eliminate blockages. Feedback can be provided to an operator that a lock is removed as described above. In addition, the system may have a relief valve to ensure that, once a blockage has been removed, the pressure at a tissue site cannot rise beyond a predetermined safe limit.
[0114] The 500 feedback system and the 600 feedback system can be low cost and customized for specific regions and markets. For example, by using a simple pressure sensor and an LED indicator, as illustrated in relation to Figure 5, the cost can be substantially reduced. If additional functionality is desired, additional components such as additional LEDs or pressure sensors can be added to provide additional information. In some ways, feedback systems can provide generic visual feedback on whether reduced pressure therapy is being effectively administered using a wall suction source. The system can be disposable, usable by a single patient or reusable. By creating different functional configurations, feedback systems can be modified to suit many needs.
[0115] The devices and systems described herein can provide variable negative pressure settings to an operator, feedback to an operator in escaping conditions, feedback to an operator in blocking conditions, feedback to an operator in full vessel conditions, can be low cost, can be disposable, can be used by a single patient or reusable, and can be highly configurable.
[0116] It should be apparent from the above that systems, methods and devices with significant advantages have been described. Although shown in only
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61/61 In some ways, the systems, methods and apparatus illustrated are susceptible to various changes, modifications and uses covered by the claims that follow.

权利要求:
Claims (31)
[1]
1. REDUCED PRESSURE SYSTEM, characterized by comprising:
a regulator comprising:
a feed chamber adapted to be fluidly coupled to a cover, a control chamber adapted to be fluidly coupled to the cover, a load chamber fluidly coupled to the feed chamber through a port, and a regulating valve coupled to the control chamber and operable to reciprocate at least partially within the control chamber to control fluid communication through the port based on a differential between a control pressure in the control chamber and a therapy pressure; and a feedback system comprising:
a pressure sensor adapted to be fluidly coupled to the control chamber, and a signal interface communicatively coupled to the pressure sensor and adapted to signal an operating state of the reduced pressure system based on a pressure measured by the pressure sensor pressure.
[2]
2. SYSTEM, according to claim 1, characterized in that the pressure sensor is a first pressure sensor and the feedback system further comprises a second pressure sensor adapted to be fluidly coupled to the supply chamber to determine a pressure of feed in the feed chamber.
[3]
3. SYSTEM, according to one of the claims
Petition 870160011817, of 03/31/2016, p. 11/19
2/7
1 or 2, characterized in that the signal interface is a light emitting diode.
[4]
4. SYSTEM, according to claim 1 or 2, characterized in that the signal interface is a liquid crystal screen.
[5]
5. SYSTEM, according to any one of claims 1 to 4, characterized in that the regulator further comprises a potentiometer communicatively coupled to the regulating valve.
[6]
A system according to any one of claims 1 to 5, characterized in that it comprises a source of reduced pressure fluidly coupled to the loading chamber.
[7]
7. SYSTEM, according to claim 6, characterized in that it further comprises a wall suction source fluidly coupled to the loading chamber.
[8]
8. SYSTEM, according to claim 1, characterized in that it further comprises the cover adapted to be fluidly coupled to a tissue site.
[9]
9. SYSTEM, according to claim 1, characterized in that the regulating valve comprises:
a valve member configured to variablely engage the port; and a regulating spring coupled to the valve member and which can be compressed in a variable manner to select the therapy pressure.
[10]
10. METHOD FOR REGULATING A THERAPEUTIC PRESSURE IN A REDUCED PRESSURE THERAPY SYSTEM, the method characterized by comprising:
reduce a loading pressure in a loading chamber
Petition 870160011817, of 03/31/2016, p. 12/19
3/7 to stay under a therapy pressure;
regulate fluid communication between a feed chamber and the load chamber based on a differential between a control pressure in a control chamber and the therapy pressure;
measure the control pressure in the control chamber; and signaling an operating state of the reduced pressure therapy system based on the measurement of the control pressure in the control chamber.
[11]
11. METHOD, according to claim 10, characterized by the signaling of the operating state comprising illuminating a light-emitting diode.
[12]
12. METHOD, according to claim 10, characterized by the signaling of the operating state comprising operating a liquid crystal display to present the operating state.
[13]
13. METHOD according to claim 12, characterized in that the operating state is at least one of the control pressure state, the supply pressure state, a differential between the control pressure and the supply pressure, a condition leakage, a blocking condition, a full vessel condition and an overpressure condition.
[14]
14. METHOD according to any one of claims 10 to 13, characterized by measuring the control pressure in the control chamber further comprising:
fluidly attach a pressure sensor to the control chamber;
generate a signal corresponding to the control pressure
Petition 870160011817, of 03/31/2016, p. 13/19
4/7 measured by the pressure sensor; and signaling the operating state at a signal interface in response to signal reception.
[15]
15. METHOD, according to any one of claims 10 to 14, characterized in that the operative state signaling comprises signaling that the operative state is a leakage condition if the control pressure is higher than the therapy pressure.
[16]
16. METHOD, according to any one of claims 10 to 14, characterized by the signaling of the operative state comprising signaling that the operative state is an overpressure condition if the control pressure is lower than the therapy pressure.
[17]
17. METHOD according to any one of claims 10 to 14, characterized in that it further comprises measuring the supply pressure in the supply chamber.
[18]
18. METHOD, according to claim 17, characterized by further comprising:
compare the control pressure in the control chamber to the supply pressure in the supply chamber; and if the control pressure in the control chamber is higher than the supply pressure in the supply chamber, it is signaled that the operating state is a leakage condition.
[19]
19. METHOD, according to claim 17, characterized in that if the control pressure in the control chamber and the supply pressure in the supply chamber are higher than the therapy pressure, signaling that the operating state is a condition of escape.
[20]
20. METHOD, according to claim 17,
Petition 870160011817, of 03/31/2016, p. 14/19
5/7 characterized by still understanding:
compare the control pressure in the control chamber to the supply pressure in the supply chamber; and if the control pressure in the control chamber remains within a therapeutic range of the therapy pressure and the supply pressure in the supply chamber rises, signaling that the operating state is a full vessel condition.
[21]
21. METHOD according to claim 20, characterized in that the therapeutic range is between about -1333.22 Pa (-10 mm Hg) and about 1333.22 Pa (10 mm Hg) of the therapy pressure.
[22]
22. METHOD, according to claim 17, characterized by further comprising:
compare the control pressure in the control chamber to the supply pressure in the supply chamber; and if the control pressure in the control chamber does not change in response to a change in the supply pressure in the supply chamber, it is signaled that the operating state is a blocking condition.
[23]
23. METHOD, according to claim 17, characterized in that if the control pressure in the control chamber and the supply pressure in the supply chamber are absolute pressures lower than the therapy pressure, signaling that the operating state is an overpressure condition.
[24]
24. METHOD according to any one of claims 10 to 23, characterized in that it further comprises fluidly coupling a wall suction source to the
Petition 870160011817, of 03/31/2016, p. 15/19
6 / Ί loading chamber to provide reduced pressure to the loading chamber.
[25]
25. FEEDBACK SYSTEM TO MONITOR THE APPLICATION OF REDUCED PRESSURE THERAPY BY A SYSTEM OF REDUCED PRESSURE THERAPY, the feedback system characterized by comprising:
a printed circuit board;
a pressure sensor coupled communicatively to the printed circuit board and adapted to be fluidly coupled to a control chamber in a regulator;
a signal interface communicatively coupled to the printed circuit board and the pressure sensor, and adapted to indicate an operating state of the reduced pressure therapy system; and a potential source communicatively coupled to the printed circuit board, pressure sensor and signal interface to supply electrical potential to the printed circuit board, pressure sensor and signal interface.
[26]
26. SYSTEM, according to claim 25, characterized in that the pressure sensor is a first pressure sensor and the feedback system further comprises a second pressure sensor adapted to be fluidly coupled to a supply chamber in the regulator.
[27]
27. SYSTEM, according to claim 25 or 26, characterized in that the signal interface is a light emitting diode.
[28]
28. SYSTEM, according to claim 25 or 26, characterized in that the signal interface is a liquid crystal screen.
Petition 870160011817, of 03/31/2016, p. 16/19
7/7
[29]
29. SYSTEM according to any one of claims 25 to 28, characterized in that a potentiometer is communicatively coupled to the regulator and to the printed circuit board.
[30]
30. SYSTEM, according to any one of claims 25 to 29, characterized in that it further comprises a source of reduced pressure fluidly coupled to a regulator load chamber.
[31]
31. SYSTEM, according to any one of claims 25 to 29, characterized in that it further comprises a wall suction source fluidly coupled to a regulator loading chamber.

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同族专利:

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公开号 | 公开日

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CN105744918A|2016-07-06|

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EP3052156B1|2020-12-23|

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US10016543B2|2018-07-10|

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WO2015050654A2|2015-04-09|

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EP3052156A2|2016-08-10|

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CN105744918B|2020-11-20|

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US20180280597A1|2018-10-04|

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WO2015050654A3|2015-07-30|

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US20150094673A1|2015-04-02|

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法律状态:
2020-03-24| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2021-07-13| B25A| Requested transfer of rights approved|Owner name: 3M INNOVATIVE PROPERTIES COMPANY (US) |

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2021-10-19| B350| Update of information on the portal [chapter 15.35 patent gazette]|

优先权:

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申请号 | 申请日 | 专利标题

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US201361885758P| true| 2013-10-02|2013-10-02|

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PCT/US2014/053452|WO2015050654A2|2013-10-02|2014-08-29|Diposable reduced-pressure therapy system with electronic feedback|

---