REDUCED PRESSURE SYSTEM

专利摘要:
The systems, methods and apparatus for providing feedback for treating reduced pressure of a tissue site are described. A regulator may include a fluidly coupled supply chamber in the bandage, a fluidly coupled control chamber in the bandage, a fluidly coupled loading chamber in the supply chamber through a port, and a regulable valve operable to the bandage. control of fluid communication through the door based on a pressure differential between the control chamber and a therapy pressure. The feedback system may include one or more fluidly coupled mechanical feedback interfaces on the regulator for providing a signal from at least one of a reduced pressure therapy application, a leakage condition, an obstruction condition and a full canister condition.
公开号:BR112016007156A2
申请号:R112016007156
申请日:2014-10-01
公开日:2020-06-16
发明作者:Andrew Pratt Benjamin；Brian Locke Christopher；Daniel John Coulthard Richard
申请人:Kci Licensing Inc；
IPC主号:

专利说明:

REDUCED PRESSURE SYSTEM
RELATED ORDER
[001] The present invention claims the benefit, under 35 USC § 119 (e), of the filing of US Provisional Patent Application serial number 61 / 885,781, entitled DISPOSABLE REDUCED-PRESSURE THERAPY SYSTEM WITH MECHANICAL FEEDBACK (PRESSURE THERAPY SYSTEM DISPOSABLE REDUCED WITH MECHANICAL BACKPACK), deposited on October 2, 2013, which is hereby incorporated as a reference for all purposes.
TECHNICAL FIELD
[002] The discussion matter described here generally refers to the monitoring of reduced pressure therapy and, more particularly, but not as a limitation, the mechanical feedback of the reduced pressure therapy provided by a wall suction source.
BACKGROUND
[003] Clinical studies and practice have shown that reducing pressure near a tissue site can increase and accelerate the growth of new tissue at the tissue site. The applications of this phenomenon are numerous, but they have proved to be particularly advantageous for the treatment of injuries. Regardless of the etiology of an injury, whether it is trauma, surgery or other cause, proper care of the wound for the outcome is important. The treatment of injuries with reduced pressure is usually
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2/110 referred to as reduced pressure therapy, but may also be known by other names, including negative pressure injury therapy and vacuum therapy, for example. Reduced pressure therapy can provide several benefits, including migration of epithelial and subcutaneous tissues, better blood flow and microdeformation of the tissue at an injury site. Together, these benefits can increase the development of granulation tissue and reduce curing 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 the respective application, and the development and operation of reduced pressure systems, components and processes continue to present significant challenges to manufacturers, healthcare providers and patients.
SUMMARY
[005] The illustrative modalities of systems, methods and devices for regulating pressure are described below. One of these illustrative modalities can be described as a reduced pressure system. The reduced pressure system can include a bandage and a regulator. The regulator may include a supply chamber adapted to be fluidly coupled to the bandage and a control chamber adapted to be fluidly coupled to the bandage. The regulator may also include a loading chamber fluidly coupled to the supply chamber through a door. A regulator valve can be coupled to the control chamber and operable to reciprocate, at least partially, inside the control chamber.
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3/110 control for the control of fluid communication through the port based on a differential between a control pressure in the control chamber and a therapy pressure. The reduced pressure system may also include a feedback interface fluidly coupled to the regulator and adapted to signal an operating state of the reduced pressure therapy system in response to a pressure received by the fluid coupling.
[006] Another illustrative modality refers to a method for regulating pressure in a reduced pressure therapy system. The method reduces a loading pressure in a loading chamber under a therapy pressure. The method regulates fluid communication between a supply chamber and the loading chamber based on a differential between a control pressure in a control chamber and the therapy pressure. The method fluidly couples a feedback interface between at least two between the control chamber, the loading chamber, a bandage and a reduced pressure source. The method signals an operating state of the reduced pressure therapy system with the feedback interface in response to a pressure received by the fluid coupling.
[007] Yet another illustrative modality refers to a feedback system for monitoring the application of reduced pressure therapy. The feedback system includes at least one feedback interface adapted to be fluidly coupled between a source of reduced pressure and a bandage. The feedback interface indicates an operating status of
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4/110 a reduced pressure system in response to at least one between a leakage condition, an overpressure condition, an obstruction condition, a Full Container condition and a reduced pressure therapy application.
[008] In yet another modality, a reduced pressure system is described. The system can include a bandage and a regulator. The regulator may include a supply chamber adapted to be fluidly coupled to the bandage and a loading chamber fluidly coupled to the supply chamber through a door. The regulator may have a regulator valve attached to the loading chamber and operable to reciprocate to control fluid communication through the port based on a differential between ambient pressure and therapy pressure. The system may also include a feedback interface fluidly coupled to the regulator and adapted to signal an operating state of the reduced pressure therapy system in response to a pressure received by the fluid coupling.
[009] Other features and advantages will become evident with reference to the drawings and the following detailed description.
[010] BRIEF DESCRIPTION OF THE DRAWINGS
[011] Figure 1 is a functional block diagram of an example modality of a reduced pressure therapy system that can regulate therapeutic pressure according to this specification;
[012] Figures 2A and 2B are schematic cross-sections of an example
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5/110 regulator in the reduced pressure therapy system;
[013] Figure 3A is a schematic cross-section of another modality of a regulator for use with a reduced pressure therapy system;
[014] Figure 3B is an exploded sectional view of the regulator of Figure 3A;
[015] Figure 3C is a schematic cross-section of the regulator of Figure 3A with a regulator valve in an open position;
[016] Figure 3D is an exploded sectional view of another modality of a regulator for use with a reduced pressure therapy system;
[017] Figure 3E is a schematic cross-section of the regulator of Figure 3D with a regulator valve in an open position;
[018] Figure 3F is a schematic cross-section of the regulator of Figure 3D with a regulator valve in a closed position;
[019] Figure 4A is a schematic cross-section of an example embodiment of a reduced pressure therapy system using the regulator of Figure 3 A;
[020] Figure 4B is a schematic cross-section of an example embodiment of an audible flow indicator that can be used with the reduced pressure therapy system of Figure 4A;
[021] Figure 4C is a schematic cross-section of an example modality of a reduced pressure therapy system using the regulator of Figure 3D;
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[022] Figure 5A is a perspective view of a feedback interface that can be used with some modalities of the reduced pressure therapy system of Figure 4A or Figure 4C;
[023] Figure 5B is a side view of the feedback interface of Figure 5A;
[024] Figure 5C is a sectional view of the feedback interface of Figure 5A;
[025] Figure 5D is a side view of the feedback interface of Figure 5A in a first position;
[026] Figure 6A is a schematic sectional view of a feedback interface that can be used with some modalities of the reduced pressure therapy system of Figure 4A or Figure 4C;
[027] Figure 6B is a side view of the feedback interface of Figure 6A;
[028] Figure 7A is a schematic sectional view illustrating additional details that can be associated with an example state of the feedback interface of Figure 6A;
[029] Figure 7B is a side view of the feedback interface of Figure 7A;
[030] Figure 8A is a schematic sectional view illustrating additional details that can be associated with another example state of the feedback interface of Figure 6A;
[031] Figure 8B is a side view of the feedback interface of Figure 8A;
[032] Figure 9A is a sectional view
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7/110 schematic of another feedback interface that can be used with some modalities of the reduced pressure therapy system of Figure 4A or Figure 4C;
[033] Figure 9B is a side view of the feedback interface of Figure 9A;
[034] Figure 10A is a schematic sectional view illustrating additional details that can be associated with an example state of the feedback interface of Figure 9A;
[035] Figure 10B is a side view of the feedback interface of Figure 10A;
[036] Figure 11A is a schematic sectional view illustrating additional details that can be associated with another example state of the feedback interface of Figure 9A;
[037] Figure 11B is a side view of the feedback interface of Figure 11A;
[038] Figure 12A is a schematic sectional view of another feedback interface that can be used with some modalities of the reduced pressure therapy system of Figure 4A or Figure 4C;
[039] Figure 12B is a side view of the feedback interface of Figure 12A;
[040] Figure 13A is a schematic sectional view illustrating additional details that can be associated with an example state of the feedback interface of Figure 12A;
[041] Figure 13B is a side view of the feedback interface of Figure 13A;
[042] Figure 14 is a sectional view
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8/110 schematic of another feedback interface that can be used with some modalities of the reduced pressure therapy system of Figure 4A or Figure 4C;
[043] Figure 15 is a schematic sectional view illustrating additional details that can be associated with an example state of the feedback interface of Figure 14;
[044] Figure 16 is a schematic sectional view of another feedback interface that can be used with some modalities of the reduced pressure therapy system of Figure 4A or Figure 4C;
[045] Figure 17 is a schematic sectional view illustrating additional details that can be associated with an example state of the feedback interface of Figure 14;
[046] Figure 18 is a sectional perspective view of another feedback interface that can be used with some modalities of the reduced pressure therapy system of Figure 4A or Figure 4C;
[047] Figure 19 is a schematic sectional view illustrating additional details that can be associated with an example state of the feedback interface of Figure 18; and
[048] Figure 20 is a schematic sectional view illustrating additional details that can be associated with an example state of the feedback interface of Figure 18.
DETAILED DESCRIPTION
[049] The attached claims present new and useful systems, methods and devices associated with the
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9/110 pressure monitoring. The objectives, advantages and a preferred way of creating and using systems, methods and devices can be better understood by referring to the following detailed description in conjunction with the accompanying drawings. The description provides information that allows a person skilled in the art to create and use the claimed discussion material, but may omit certain details already well known in the art. Furthermore, descriptions of various alternatives using terms such as or do not necessarily require mutual exclusivity, unless clearly required by the context. The claimed discussion material may also cover alternative modalities, variations and equivalents not specifically described in detail. The following detailed description should, therefore, be considered as illustrative and not limiting.
[050] The example modalities can also be described here in the context of reduced pressure therapy applications, but many of the features and advantages are easily applicable to other environments and industries. The spatial relationships between several elements or for the spatial orientation of several elements can be described as described in the attached drawings. In general, these relationships or orientations assume a referral system consistent with, or relative to, a patient in a position to receive reduced pressure therapy. However, as should be recognized by those skilled in the art, this reference system is merely a descriptive device and not a strict prescription.
[051] Figure 1 is a simplified functional block diagram of an example modality of a
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10/110 reduced pressure therapy system 100 that can regulate therapeutic pressure according to this specification. As illustrated in the illustrative embodiment of Figure 1, the reduced pressure therapy system 100 can include a bandage 102 fluidly coupled to a reduced pressure source 104. A regulator or controller, such as a regulator 106, can also be coupled fluidly in bandage 102 and in the source of reduced pressure 104. Bandage 102 generally includes a cloth, such as a cloth 108, and a fabric interface, such as a collector 110. The reduced pressure therapy system 100 it can also include a fluid container, such as a container 112, coupled to the bandage 102 and the reduced pressure source 104.
[052] 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 directly coupled to regulator 106 and indirectly coupled to bandage 102 by regulator 106. The components can be fluidly coupled together to provide a pathway for fluid transfer (or ie 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 here, generally refers to a tube, pipe, hose, conduit or other structure with one or more lumens adapted for the transmission of fluids between two ends. Usually, a tube is an elongated and cylindrical structure with some flexibility, but the geometry and stiffness can vary. In some modalities, the components
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11/110 can additionally or alternatively be coupled due to physical proximity, being part of a single structure, or being formed from the same piece of material. The coupling may also include mechanical, thermal, electrical or chemical coupling (such as a chemical bond) in some contexts.
[053] In operation, a fabric interface, such as the collector 110, can be placed inside, over, in, against or else adjacent to a fabric location. For example, collector 110 can be placed against a fabric location, and cloth 108 can be placed over collector 110 and sealed to the fabric near the fabric location. Tissue near a tissue site is often an intact epidermis peripheral to the tissue site. In this way, bandage 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 by the tissue interface in the sealed therapeutic environment can induce macrotension and microtension at the tissue site, as well as remove exudates and other fluids from the tissue site. The removed exudates and other fluids can be accumulated in Container 112 and disposed of properly.
[054] The mechanics of the fluid of using a reduced pressure source to reduce pressure in another component or location, such as within a sealed therapeutic environment, can be mathematically complex. However, the basic principles of the mechanics of
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12/110 fluids applicable to reduced pressure therapy are generally well known to those skilled in the art, and the pressure reduction process can be described here illustratively as delivery, distribution or generation of reduced pressure, for example.
[055] In general, exudates and other fluids circulate towards the lowest pressure along a fluid path. This guidance is generally assumed for the purpose of describing various functionalities and components of reduced pressure therapy systems here. Thus, in the context of reduced pressure therapy, the term descending usually implies something in a fluid path relatively closer to a source of reduced pressure and, conversely, the term ascending implies something relatively further away from a source of reduced pressure. Similarly, it may be convenient to describe certain functionalities in terms of entering or leaving fluid in such a reference system. However, a fluid path can also be reversed in some applications, such as replacing a source of positive pressure, and this descriptive convention should not be interpreted as a limiting convention.
[056] The term local tissue in this context generally refers to an injury or defect located in or within the tissue, including, but not limited to, bone tissue, adipose tissue, muscle tissue, nervous tissue, dermal tissue, vascular tissue, connective tissue, cartilage, tendons or ligaments. An injury can include chronic, acute, traumatic, subacute and open injuries, partial thickness burns, ulcers (such as
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13/110 example, diabetic ulcers, pressure or venous insufficiency), flaps and grafts, for example. The term local tissue can also refer to areas of tissue that do not necessarily have wounds or defects, but instead are areas in which it may be desired to add or encourage additional tissue growth. For example, reduced pressure can be used in certain tissue areas for the growth of additional tissue that can be harvested and transplanted to another tissue location.
[057] Reduced pressure generally refers to a pressure less than a local ambient pressure, such as ambient pressure in a local environment external to a sealed therapeutic environment provided by bandage 102. In many cases, local ambient pressure can also be atmospheric pressure near a patient. Alternatively, the pressure may be less than a hydrostatic pressure associated with the tissue at the site of the tissue. Unless otherwise stated, the pressure values given here are gauge pressures. Similarly, references to increases in reduced pressure usually refer to a decrease in absolute pressure, while decreases in reduced pressure usually refer to an increase in absolute pressure.
[058] A source of reduced pressure, such as the source of reduced pressure 104, can be an air reservoir at reduced pressure, or it can be a manual or power supply device that can reduce pressure in a sealed volume, such as a vacuum pump, a suction pump, a wall suction port available in many healthcare facilities, or a micro pump, for example. A reduced pressure source can
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14/110 be housed within, or used in conjunction with, other components, such as sensors, processing units, alarm indicators, memory, databases, software, display devices or operator interfaces that make therapy easier. reduced pressure. Although the amount and nature of the reduced pressure applied to a tissue site may vary according to therapeutic requirements, the pressure usually ranges from -5 mm Hg (667 Pa) to -500 mm Hg (-66.7 kPa). Common therapy ranges from -75 mm Hg (-9.9 kPa) to -300 mm Hg (-39.9 kPa).
[059] A fabric interface, such as collector 110, can generally be adapted to be in contact with a fabric location or other layers of a bandage, such as bandage 102. A fabric interface may be partial or totally in contact with a tissue site. If a tissue site is a wound, for example, a tissue interface can partially or completely fill the wound, or it can be placed over the wound. A fabric interface can take many forms, and can have many sizes, shapes or thickness depending on a variety of factors, such as the type of treatment being implemented or the nature and size of a fabric location. For example, the size and shape of a fabric interface can be adapted to the contours of deep and irregularly shaped fabric locations.
[060] Generally, a collector, such as collector 110, is a substance or structure adapted for the distribution or removal of fluids from a tissue site. A collector can include flow channels or trajectories that
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15/110 can distribute fluids supplied to, and removed from, a tissue site. In an illustrative embodiment, the flow channels or trajectories can be interconnected to improve the distribution of fluids delivered to, or removed from, a tissue site. For example, a collector can be an open cell foam, a collection of porous fabrics and other porous material, such as gauze or felt mat, which generally includes structural elements arranged for the formation of flow channels. Liquids, gels and other foams can also include or be cured to include flow channels.
[061] In an illustrative embodiment, the collector 110 can be a porous foam plate with interconnected cells adapted for the distribution of reduced pressure from one side to the other of a tissue site. The foam material can be hydrophobic or hydrophilic. In a non-limiting example, the collector 110 may be cross-linked polyurethane foam, such as GranuFoam® bandage available from Kinetic Concepts, Inc. of San Antonio, Texas.
[062] In some embodiments, such as for example arrangements in which the collector 110 can be made of a hydrophilic material, the collector 110 can also draw fluid from a tissue site while still distributing reduced pressure to the tissue site. The extraction properties of the collector 110 can draw fluid from a tissue site through capillary flow or other extraction mechanisms. An example of a hydrophilic foam is an open cell foam of polyvinyl alcohol, such as V.A.C. WhiteFoam® available from Kinetic Concepts, Inc. of San Antonio, Texas. Other hydrophilic foams can
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16/110 include those made of polyether. Other foams that may have hydrophilic characteristics include hydrophobic foams that have been treated or coated to provide hydrophilicity.
[063] The tissue interface can further promote granulation in a tissue location if the pressure within a sealed therapeutic environment is reduced. For example, any or all of the surfaces of the collector 110 may have an irregular, rough or pointed profile that can induce microtensions and stresses in a tissue location if the reduced pressure is applied by the collector 110.
[064] In some example modalities, 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 framework for new cell growth, or a framework material can be used in conjunction with the tissue interface to promote cell growth. In general, a frame material can be a biocompatible or biodegradable substance or structure used to improve or promote cell growth or tissue formation, such as a three-dimensional porous structure that provides a model for cell growth. Illustrative examples of frame materials include calcium phosphate, collagen, PLA / PGA, coral hydroxyapatites, carbonates or processed allograft materials.
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[065] Cloth 108 is an example of a sealing member. A sealing member can be constructed from one 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, an impermeable or semi-permeable elastomeric barrier or film that can provide a suitable seal for maintaining a reduced pressure in a fabric location for a given source of reduced pressure. For semipermeable materials, the permeability should generally be low enough to maintain a desired reduced pressure. A connecting device can be used to connect a sealing member to a connecting surface, such as intact epidermis, a caulking or other sealing member. The connecting device can take many forms. For example, a connector may be a pressure sensitive and medically acceptable adhesive that extends around a periphery, a portion or an entire sealing member. Other exemplary embodiments of a connection device may include double-sided adhesive tape, glue, hydrocolloid, hydrogel, silicone gel, organic gel or an acrylic adhesive.
[0 66] A Container, such as Container 112 in Figure 1, largely includes a canister, 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 required for collection, storage and disposal.
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18/110 fluid disposal. In other environments, fluids can be properly disposed of without storing a rigid container, and a reusable container can reduce waste and costs associated with reduced pressure therapy.
[067] In general, reduced pressure therapy can be beneficial for injuries of all severity, but the cost and complexity of reduced pressure therapy systems often limit the application of reduced pressure therapy to large, highly exudate injuries present in patients who are undergoing acute or chronic care, as well as other severe injuries that are not easily susceptible to healing without applying reduced pressure. Many development zones may not have access to electrical reduced pressure sources specific to reduced pressure therapy. Instead, these zones can rely on wall suction sources to supply reduced pressure. These sources of wall suction can be seen as a practical, adequate and more economical alternative to a specific therapy unit with electronic controls.
[068] Suction wall sources are capable of providing continuous, or almost continuous, supplies of reduced pressure. However, wall suction sources can provide a wide range of reduced pressures and may require an operator to select an appropriate reduced pressure to be supplied. If the reduced pressure is set too low at the wall suction source, removal of exudates and other wound fluids from the tissue site will not occur. If the reduced pressure is too high, the reduced pressure therapy can cause
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19/110 internal bleeding and further damage to a tissue site. For at least these reasons, the treatment of a reduced pressure tissue site provided by a wall suction source must be regulated for reduced pressure therapy.
[069] The reduced pressure therapy system 100 can overcome these failures and others by providing mechanical regulation and therapeutic pressure feedback. In some embodiments, for example, a regulator can regulate fluid communication between a supply chamber and a loading chamber, and one or more feedback interfaces can provide feedback to alert operators of a state of reduced pressure therapy operation during the provision of reduced pressure therapy. For example, feedback interfaces 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 leak condition , an obstruction condition, a full vessel condition and an overpressure condition. In some embodiments, the reduced pressure therapy system 100 can provide a highly configurable system that is low-cost, disposable, single-patient or reusable.
[070] Regulators
[071] Figures 2A and 2B are simplified schematic cross sections illustrating details of an example modulator of regulator 200. Regulator 200 is an example modality of regulator 106 in Figure 1. As illustrated, regulator 200 may include a housing 201 with a loading chamber 2 02, a loading chamber
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20/110 filling 204 and a control chamber 20 6. The loading chamber 202 can be fluidly coupled to the filling chamber 204 by a conduit, a passage or a door, such as a loading door 205. A door 208 it can provide fluid communication between the 206 control chamber and an ambient pressure source. The loading chamber 202 can also include a port, such as a port 210, which can be fluidly coupled to a source of reduced pressure, such as the reduced pressure source 104. The loading chamber 202 can be adapted for receiving reduced pressure from a device that can be manually activated, or alternatively that can be powered by electrical or other means.
[072] A supply port 212 can fluidly couple supply chamber 204 to a bandage, such as bandage 102 in Figure 1. A control port 214 can fluidly couple control chamber 206 to bandage 102 For example, in one embodiment, a first lumen, such as a supply lumen 216a, can fluidly connect supply port 212 and supply chamber 204 in a bandage. A second lumen, such as a feedback lumen 216b, can fluidly couple control port 214 and control chamber 206 to bandage 102. In some embodiments, supply lumen 216a and 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 to attach a bandage to the supply port 212 and the control port 214.
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[073] A T-piece 215 can be coupled to the feedback lumen 216b. The T-piece 215 may have a first pass 215a and a second pass 215b. The first pass 215a and the second pass 215b can be perpendicular to each other 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 bandage. For example, the first passage 215a can be fluidly coupled to the feedback lumen 216b. The second passage 215b can be fluidly coupled to another device, such as a pressure sensor, a fluid source or a sampling device. In some embodiments, a pressure sensor can be fluidly coupled to the second pass 215b and be in fluid communication with a control pressure in the control chamber 206.
[074] A T-piece 217 can be attached to the supply lumen 216a. The T-piece 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 each other and be in fluid communication with each other. At least one of the passages can be fluidly coupled in line between the supply chamber 204 and a bandage. For example, the first passage 217a can be fluidly coupled to the supply lumen 216a. The second passage 217b can be fluidly coupled to another device, such as a pressure sensor, a fluid source or a sampling device. In some embodiments, a pressure sensor can be fluidly coupled to the second
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22/110 passage 217b and is in fluid communication with a supply pressure in the supply chamber 204.
[075] A regulator valve 220 can be operably associated with loading port 205 to regulate fluid communication between loading chamber 202 and supply chamber 204. In some embodiments, regulator valve 220 may include an actuator , a valve body and an elastic member. A driver can be a flexible or mobile barrier, such as a piston 222. A valve body can be, for example, a generally rigid structure with a first end attached to, joining, leaning against, or engaging on piston 222, and movable with piston 222, such as a stem 224. A second end of the valve body can generally be of a size and shape for engaging and / or sealing the loading port 205. In some embodiments , the stem 224 can extend through a partition into the supply chamber 204. An elastic member can be a spring, rubber or other elastic structure, such as a regulator spring 226. Regulator spring 226 can generally be arranged between piston 222 and loading port 205. Regulator spring 226 can be arranged inside control chamber 206, but can be arranged in supply chamber 204 in other embodiments. Regulator spring 226 in this embodiment can be a helical spring that is coaxial with respect to stem 224. Regulator spring 226 can tilt piston 222 against ambient pressure 228 in control chamber 206.
[076] In some embodiments, the shell 201 can be formed from two components. For example, the
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The housing 201 can be formed from a lower housing 201a and an upper housing 201b, as shown in the illustrative embodiment of Figures 2A and 2B. In this example, the lower housing 201a and the upper housing 201b each include an end wall, a side wall joining the end wall and an open end opposite the end wall. The bottom shell 201a or the top shell 201b can have an outer dimension less than an inner dimension, 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 201a and the upper housing 201b can be engaged to allow relative movement between them. In more particular embodiments, the lower housing 201a and the upper housing 201b may each have cylindrical side walls and round end walls.
[077] The loading chamber 202 can generally be defined by adjoining walls of housing 201, such as an end wall of housing 201, a wall or side walls of housing 201, and a partition within housing 201, for example the chamber wall 207a. The supply chamber 204 can also generally be defined by adjoining walls within the housing 201. For example, the supply chamber 204 in Figures 2A and 2B can generally be defined by the chamber wall 207a, a wall or side walls of the housing 201, and another partition, such as the chamber wall 207b. The control chamber 206 can be similarly described, for example, as a chamber defined by the chamber wall 207b,
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24/110 the wall or side walls of the housing 201, and another end wall of the housing 201. In this example embodiment, the loading chamber 202 and the supply chamber 204 can have a common wall, such as the chamber wall 207a. The supply chamber 204 and the control chamber 206 may also have a common wall, for example the chamber wall 207b. Loading chamber 202 and supply chamber 204 can be fluidly isolated from each other, except loading port 205. Loading chamber 202 and supply chamber 204 can be fluidly isolated from the environment . In addition, the control chamber 206 can be fluidly isolated from the loading chamber 202 and the supply chamber 204.
[078] The regulator valve 220 in this example can be arranged partially inside the control chamber 206 and partially inside the supply chamber 204, with the circumferential edges of the piston 222 leaning against, or engaging the, wall or side walls of the chamber control valve 206. The interface between piston 222 and the walls of the control chamber 206 can also provide a fluid seal, dividing the control chamber 20 6 into an ambient pressure zone 228 and a control pressure zone 230. However , the regulator valve 220 can also reciprocate within the control chamber 206 while maintaining the fluid seal. For example, regulator valve 220 may additionally include flexible O-rings 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 control chamber 206.
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[079] In operation, the pressure in the supply chamber 204 can be distributed in a remote chamber, an environment or other location through the supply port 212. For example, the pressure in the supply chamber 204 can be distributed in 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 20 6 can be equalized with the pressure in the remote location via the control port 214. In reduced pressure therapy applications , the control pressure 230 must be lower than the ambient pressure 228, resulting in a pressure differential across regulator valve 220. To simplify the description further, the force at regulator valve 220 resulting from the pressure differential at Opposite sides of piston 222 can be referred to as a differential force. The regulator spring 226 also generally exerts a force on the regulator valve 220. In the expected operating variations, the force of the regulator spring 226 is directly proportional to a displacement of the ends of the regulator spring 226 from a relaxed position. 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 force of the regulator spring 226 can be combined to determine a resulting force acting on regulator valve 220. The resulting force can cause regulator valve 220 to move reciprocally within the control chamber 206 , how put
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26/110 example along a central axis 231 aligned with the loading port 205.
[080] Regulator spring 226 can be selected, adjusted, modified, regulated or else calibrated, so that control pressure 230 has to fall below a threshold value (such as a target pressure) before resulting force can move regulator valve 220 to a position that closes loading port 205. In some embodiments, for example, piston 222 can rotate within housing 201 to adjust the compression of regulator spring 226. In the illustrative embodiment of Figures 2A and 2B, piston 222 includes a projection 232 that can be rigidly attached to a sleeve 234 of the upper housing 201b, and the stem 224 can be threaded or have a threaded portion engaged in the projection 232. The stem 224 can be radially locked in housing 201 with a keyed functionality. In these embodiments, piston 222 and sleeve 234 are generally blocked radially, and the compression of regulator spring 226 can be adjusted by turning the upper housing 201b, which can cause piston 222 to rotate relative to stem 224. The change in Compression of regulator spring 22 6 results in a change in the force of regulator spring 226 acting on regulator valve 220 and, therefore, a change in the control pressure threshold value 230 is required to actuate regulator valve 220. In many applications, this control pressure threshold 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 modalities, the
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27/110 therapy pressure can be adjusted by turning the upper housing 201b. In even more particular embodiments, the upper shell 201b can be calibrated to indicate various levels of therapy pressure.
[081] In this way, the loading chamber 202 can be loaded to reduce the pressure in the loading chamber 202, 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 force of the regulator spring 226 and a differential force. A differential force on piston 222 can be produced by a pressure differential across piston 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 reduced pressure therapy applications, loading chamber 202 can be charged to a lower pressure than 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.
[082] If regulator valve 220 is calibrated for a given therapy pressure and control pressure 230 is greater than the therapy pressure, the force of the regulator spring 226 must exceed the differential force, and the resulting force must trigger the regulator valve 220, moving regulator valve 220 to an open position (see Figure 2B) in which stem 224 disengages from loading port 205. disengaging stem 224 from loading port 205 can also be referred to as
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28/110 loading door 205 opening. The pressure between the loading chamber 202 and the filling chamber 204 can be equalized by the open loading door 205. While the pressure in the loading chamber 202 and in the filling chamber 204 continues to equalizing, the pressure in the supply chamber 204 continues to decrease. Unless there is a complete obstruction in 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. In addition, unless there is a complete obstruction in 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. While the control pressure 230 decreases and approaches the therapy pressure, the differential force increases until it exceeds the force of the regulator spring 226, causing the stem 224 to engage the loading port 205. The engagement of the stem 224 to the loading port loading 205 can substantially reduce or prevent fluid communication between loading chamber 202 and supply chamber 204 through loading port 205, as illustrated in the illustrative embodiment of Figure 2A. The engagement of the rod 224 in the loading door 205 can also be referred to as closing the loading door 205. The loading door 205 generally remains 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 power drops.
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29/110 pressure and partial obstructions, particularly in the fluid path between the supply chamber 204 and a controlled environment, since the pressure in the controlled environment can be directly measured by the feedback lumen 216b.
[083] Figure 3A is a cross-sectional view illustrating a regulator 300 that can be associated with some modalities of the reduced pressure therapy system 100. Regulator 300 is another example of regulator 106. Regulator 300 may be similar to the regulator 200 of Figures 2A and 2B in many respects, and may include a housing 302 and a regulator valve 32 6. Housing 302 may have an end wall 303, one or more side walls 301, and an open end 305 opposite the wall end wall 303. The side walls 301 can be coupled to the peripheral portions of, and generally perpendicular to the end wall 303.
[084] The housing 302 can be partitioned by a first wall 304 and a second wall 306 to form a loading chamber 308, a filling chamber 310 and a control chamber 312. In some embodiments, the loading chamber 308 can be connect to the supply chamber 310, arranged between the end wall 303, the first wall 304 and the side walls 301. The supply chamber 310 can be disposed between the loading chamber 308 and the control chamber 312. For example, in the 3A, the first wall 304 separates the loading chamber 308 and the supply chamber 310. The supply chamber 310 can be connected by the first wall 304, the side walls 301 and the second wall 30 6. The control chamber 312 can join the supply chamber 310, as
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30/110 illustrated in the illustrative embodiment of Figure 3A. For example, the second wall 306 can separate the supply chamber 310 and the control chamber 312. The supply chamber 310 can be connected by the second wall 306, the side walls 301 and the open end 305 of the housing 302. The first wall 304 and the second wall 306 can be coupled to the side walls 301 of the housing 302 in peripheral portions of the first wall 304 and the second wall 306. In some embodiments, no fluid communication can occur between the loading chamber 308, the supply chamber 310 and the control chamber 312 in locations where the first wall 304 and the second wall 306 engage in housing 302.
[085] The casing 302, the first wall 304 and the second wall 306 can be formed of a material having sufficient strength to resist yielding if a reduced pressure is supplied to the loading chamber 308, the filling chamber 310 and the chamber control systems, such as metals, hard plastics or other suitable materials. For example, housing 302, first wall 304 and second wall 306 can resist sagging if a reduced pressure of about 150 mm Hg (-150 mm Hg gauge pressure) is supplied to the loading chamber 308, the loading chamber supply 310 or to the control chamber 312. In other exemplary embodiments, the casing 302, the first wall 304 and the second wall 306 can resist yielding if a reduced pressure of about 600 mm Hg (-600 mm Hg pressure) is provided the loading chamber 308, the filling chamber 310 or the control chamber 312.
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1/31
[086] The loading chamber 308 may include a source port 314 and a loading port 316. The source port 314 can be arranged on one of the side walls 301 of the loading chamber 308 and can be fluidly coupled to the chamber loading port 308. In some embodiments, the original 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. In some embodiments, the original port 314 can be fluidly coupled to a wall suction source by a conduit or tube. A one-way valve can be arranged on the source port 314 and oriented to prevent the flow of fluid into the loading chamber 308 through the source port 314 and allow the flow of fluid from the loading chamber 308 to exit through the source port 314.
[087] In some embodiments, loading port 316 may be arranged on the first wall 304, as shown in the illustrative embodiment of Figure 3A. The loading port 316 can fluidly couple the loading chamber 308 and the supply chamber 310. In some embodiments, the loading port 316 may have a cylindrical wall 315 and a central passage 317 that extends between the loading chamber 308 and the supply chamber 310. The cylindrical wall 315 may include a portion extending into the supply chamber 310 from the first wall 304, so that the loading port 316 ends near a central portion of the second wall 306. In some embodiments, loading port 316 can be arranged at other locations in the
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32/110 first wall 304.
[088] THE supply chamber 310 can include a door of supply 318 and a door in monitoring 319. In some modalities, the door in supply 318 can be fluidly coupled in the camera supply 310 and ! provide an interface to chamber in supply 310 . Per example, the supply port 318
it can be configured to be attached to a tube, which can be attached to a bandage or other ascending component. A one-way valve can be arranged on the supply port 318 and oriented to allow the flow of fluid into the supply chamber 310 through the supply port 318 and prevent the flow of fluid from the supply chamber 310 through the supply port 318.
[089] The monitoring port 319 can also be fluidly coupled to the supply chamber 310, providing a second interface to the supply chamber 310. In some embodiments, for example, the monitoring port 319 can be arranged on one of the walls side 301, opposite supply port 318. In other embodiments, monitoring port 319 can be close to, or adjacent to, supply port 318. Monitoring port 319 can be fluidly coupled to a device monitoring systems, such as a sensor, feedback interface or overpressure valve. In some embodiments, the monitoring port 319 may have a cover so that no fluid communication can take place through the monitoring port 319.
[090] The control chamber 312 may include a control port 321 and a monitoring port 323. In
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33/110 some modes, the control port 321 can be fluidly coupled to the control chamber 312 and provide an interface to the control chamber 312. In some embodiments, the control port 321 can be arranged on the same side of the regulator 300 than supply port 318. In other embodiments, control port 321 can be vertically aligned with supply port 318. In the illustrative embodiment of Figure 3A, control port 321 can be configured to be coupled to a tube , which can be attached to a bandage or other ascending 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 to allow the flow of fluid out of the control chamber 312 through the control port 321.
[091] Monitoring port 323 can also be fluidly coupled to control chamber 312. In some embodiments, monitoring port 323 can be opposite to control port 321. In other embodiments, monitoring port 323 can be arranged on the same side of regulator 300 as control port 321. In other embodiments, monitoring port 323 can be vertically aligned with monitoring port 319. Monitoring port 323 can be fluidly coupled to a control device. monitoring, such as a sensor, a feedback interface or an overpressure valve. In some embodiments, the monitoring port 323 may have a cover so that no fluid communication can occur through the monitoring port 323.
[092] The second wall 306 may include a
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34/110 opening 320 in a central portion near the distal end of loading port 316. As illustrated in Figure 3A, opening 320 can be axially aligned with the central passage 317. Opening 320 may be larger than the distal end of the door loading port 316, providing a slot between a peripheral portion of the opening 320 and the distal end of the loading port 316. The slot provides a fluid path between the loading port 316 and the supply chamber 310. In some embodiments, the slot between the peripheral portion of the opening 320 and the distal end of the loading port 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 port 316 may be less than 0.5 mm. In yet other alternative or additional embodiments, the distal end of the loading door 316 can be separated vertically 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. for a distance of about 0.5 mm. In other embodiments, the distance separating the distal end of the loading port 316 and the bottom surface of the second wall 306 can be greater than 0.5 mm.
[093] Regulator valve 326 can be operably associated with loading port 316 for regulating fluid communication between loading chamber 308 and supply chamber 310. Regulator valve 32 6 can be tilted to open or close loading door 316. In some embodiments, regulator valve 326 can be attached to open end 305
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35/110 of housing 302, as illustrated in Figure 3A. Regulator valve 326 can be coupled to the ends of the side walls 301 of the housing 302, opposite the side wall 303 of the housing 302. In some embodiments, the regulator valve 326 can substantially limit or prevent fluid communication through the open end 305 of the housing 302. Regulator valve 326 can include valve member 322, valve body, such as stem 328, and actuator 330. Regulator valve 326 can also include regulator cap 332, a spring regulator 334, an adjustment rod 336 and a voltage adjuster, such as a push button, lever or dial 338.
[094] Figure 3B is a schematic sectional view of regulator 300 illustrating additional details that may be associated with some modalities. In some embodiments, valve member 322 may be a flexible membrane, such as a diaphragm. In some embodiments, the valve member 322 may be generally disk-shaped with a diameter greater than the diameter of the opening 320 in the second wall 306. In other embodiments, the valve member 322 may have a shape corresponding to an opening shape 320, for example, a square, rectangular, ovoid, triangular or amorphous shape. The valve member 322 can have peripheral portions coupled to the second wall 306, and the valve member 322 can extend across the opening 320. If the valve member 322 is coupled to the second wall 306, the member of valve 322 can fluidly isolate control chamber 312 from supply chamber 310. For example, a difference in
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36/110 pressures in the supply chamber 310 and in the control chamber 312 can cause deflection of valve member 322. In some embodiments, valve member 322 may be formed of a silicone material. In some embodiments, valve member 322 may have a hardness rating between about 30 Shore A and about 50 Shore A.
[095] As shown in Figure 3B, some embodiments of loading port 316 may have a valve seat 324 at the distal end. Valve seat 324 can provide a slender or bevelled edge near the central passage 317 of loading port 316. In some embodiments, valve member 322 may include an enlarged portion 325 configured for engaging valve seat 324. For example , the valve member 322 can be positioned so that the enlarged portion 32 5 of the valve member 322 can engage a beveled edge of the valve base 324 of the loading port 316 in a closed position. If engaged in this way, it can substantially prevent fluid communication through the central passage 317 of the loading port 316.
[096] 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 if the 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 within stem 328 from the second end of stem 328. Cavity 340
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37/110 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 be offset from the housing 302 The stem 328 can also have a recess 333 disposed between the ends of the stem 328. In some embodiments, the recess 333 is annular and can be arranged close to a center of a length of the stem 328.
[097] Actuator 330 can be coupled to housing 302 so that actuator 330 covers open end 305. In some embodiments, actuator 330 extends across the open end 305 to fluidly isolate the 312 control of the environment. In some embodiments, the driver 330 may be a diaphragm with peripheral portions coupled to the ends of the side walls 301 of the housing 302. The driver 330 may have an elasticity allowing a central portion of the driver 330 to deviate from an equilibrium position while the portions peripherals of driver 330 remain affixed to housing 302. In some embodiments, driver 330 may be formed of an elastomeric material. For example, the driver 330 can be formed of a silicone. In some embodiments, driver 330 may be formed of a material such as a hardness rating between about 30 Shore A and about 50 Shore A.
[098] The driver 330 can have an opening 331 near a central portion of the driver 330. The opening 331 can receive the stem 328 so that the stem 328 extends through the driver 330. In some embodiments, the driver 330 can be coupled or sealed on stem 328.
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For example, driver 330 can be welded to stem 328 at opening 331. For example, at least a portion of driver 330 adjacent to opening 331 can be inserted into recess 333 to couple driver 330 to stem 328. In some embodiments, the movement of the stem 328 along an axis of the stem 328 causes movement of the central portion of the driver 330, and movement of the driver 330 along an axis of the stem 328 can cause movement of the stem 328.
[099] If assembled, as shown in Figure 3A, the regulator cover 332 can be attached to the housing 302 so that the regulator cover 332 is adjacent to the control chamber 312 and the open end 305. In some embodiments, regulator cap 332 covers open end 305 of housing 302 and includes a raised portion extending away from control chamber 312 near a center of regulator cap 332. In some embodiments, the raised portion may be coextensive with the end open 305 so that the regulator cover 332 can be separated from the driver 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 to the stem 328. In some embodiments, stem 328 can move relative to regulator cap 332 while remaining sealed in regulator cap 332. In other embodiments, stem 328 may not be fluidly sealed in cap d and regulator 332, so that an ambient pressure adjacent to an exterior of the regulator cover 332 can be substantially equivalent to a pressure in the area between the raised portion of the regulator cover 332 and the driver 330.
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[0100] 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 be in contact with the regulator cover 332, so that the regulator spring 334 can be compressed against the regulator cover 332. A second end of the regulator spring 334 can be adjacent with respect to to the end of the stem 328 which has the cavity 340 arranged there. Regulator spring 334 can have a length Y in a relaxed position, as illustrated in Figure 3B. In the relaxed position, regulator spring 334 cannot be extended or compressed so that regulator spring 334 does not exert a spring force. In some embodiments, a length Y1 may be the length of the regulator spring 334 in a compressed position, as illustrated in Figure 3A, for example if the regulator valve 326 obstructs fluid communication through the loading port 316.
[0101] The adjustment rod 336 can have an end disposed within the cavity 340 and can be coupled to the stem 328 so that the adjustment rod 336 and the stem 328 can move as integral members. Adjustment rod 336 can be cylindrical and have an enlarged distal end forming an adjustment cap 337 of adjustment rod 336. A portion of adjustment rod 336 can be threaded between adjustment cap 337 and the end disposed within cavity 340 In some embodiments, the adjustment rod 336 can be threaded between the adjustment cap 337 and an opening in the cavity 340 of the stem 328.
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[0102] Dial 338 may be a tubular body with 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 rod 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 at the illustrative embodiment of Figure 3A, forming a shoulder 343 between the cavity 345 and the cavity 347. The dial 338 can be arranged on the stem 328 so that the shoulder 343 faces the cavity 340. As shown in the illustrative embodiment of Figure 3A, the shoulder 343 can have an annular width substantially equal to the width of a shoulder 349 of the stem 328 formed by the cavity 340. The dial 338 can be movably coupled to the adjustment rod 336 close to the adjustment cap 337 of the adjustment rod 336. In some embodiments, the first portion 339 of the display 338 is adjacent to the adjustment cap 337 of the adjustment rod 336. In some embodiments, the surface of the cavity 345 of the first portion 339 can be threaded. Dial 338 can be threaded on adjustment rod 336, allowing dial 338 to be rotated around adjustment rod 336. Rotation of dial 338 around adjustment rod 336 can cause dial 338 to move in parallel with each other. with respect to an axis of the adjustment rod 336. In this way, the display 338 can move along the adjustment rod 336.
[0103] Figure 3C is a sectional view
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41/110 schematic of regulator 300 illustrating additional details that can be associated with some modalities of regulator 300 in an open position. The dial 338 can be positioned on the adjustment rod 336 so that one end of the second portion 341 of the dial 338 is in contact with the distal end of the regulator spring 334. For example, the dial 338 can be threaded on the adjustment rod 336 , and the additional rotation of the dial 338 in relation to the adjustment rod 336 can move the dial 338 axially closer to the regulator cover 332 to compress the regulator spring 334. The compression of the regulator spring 334 by the dial 338 shortens the length of the dial. regulator spring 334. This compression can cause the regulator spring 334 to exert a force on the display 338 by pushing the display 338 away from the regulator cover 332. In some embodiments, the regulator spring 334 can have a length Y2 if the regulator spring 334 is compressed by display 338. The force exerted by regulator spring 334 is directly proportional to the displacement of regulator spring 334 from the relaxed position. The force exerted by the regulator spring 334 on the display 338 similarly pushes the adjustment rod 336, the coupled stem 328 and the coupled valve member 322 upwards. In some embodiments, the force also pushes valve member 322 away from loading port 316 to an open position. In the open position, fluid communication can take place through loading port 316.
[0104] A differential force can also operate on the 330 driver. The differential force can be a force generated by a difference in pressures between the
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42/110 control 312 and the environment of 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 environment are substantially equal, the differential force can be approximately zero. If the control pressure in the control chamber 312 is lower than the ambient pressure, for example, if regulator 300 is being used to provide reduced pressure therapy, the differential force can act to push the actuator 330, the coupled stem 328 and the valve member 322 towards the distal end of the loading port 316.
[0105] If the differential force is greater than the force of the regulator spring 334 acting on stem 328, valve member 322 can be pushed into contact with the distal end of the loading port 316 to prevent fluid communication through the loading port. loading 316 in a closed position, as illustrated in Figure 3A. If the differential force is less than the force on regulator spring 334, valve member 322 can be pushed away from the distal end of loading port 316 to allow fluid communication through loading port 316 in the open position, shown in Figure 3C . The dial 338 can be threaded along the adjustment rod 336 to control the compression of the regulator spring 334 from the relaxed Y position. In this way, the compression of the regulator spring 334 can be controlled to select a prescribed therapy, so that the force of the regulator spring 334 can be overcome if the therapy pressure is reached in the control chamber 312.
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[0106] In other embodiments, a differential force can act on the valve member 322. For example, the supply pressure in the supply chamber 310 can exert a force on the valve member 322, and the control pressure in the control chamber 312. it can exert a force on the valve member 322. The sum of the forces acting on the valve member 322 can be referred to as a valve force. The valve force can push the valve member 322 into or out of contact with the loading port 316. In some embodiments, the valve force can act in opposition to the differential force acting on the driver 330. The relative dimensions of valve member 322 and driver 330 can be selected so that driver 330 is several times larger than valve member 322. For example, driver 330 may have a large dimension that is greater than a corresponding dimension of the member of valve 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 a similarly large difference in areas surface of actuator 330 and valve member 322. The larger surface area of actuator 330 allows the differential force acting on actuator 330 to act in an area greater than the valve force acting on valve member 322. As a consequence, the differential force acting on actuator 330 can overcome other forces acting on other components of regulator 300, such as valve member 322, allowing actuator 330 to control movement of stem 328. In some embodiments, the opening
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320 can be smaller compared to that shown, and the loading port 316 can be further separated from the bottom surface of the second wall 306. In this embodiment, the valve member 322 can be relatively smaller so that the force of the valve act on a surface area smaller than the differential force.
[0107] Figure 3D is an exploded cross-sectional view illustrating a regulator 1000 that can be associated with some modalities of the reduced pressure therapy system 100. Regulator 1000 is another example of regulator 106. Regulator 1000 can be similar to regulator 200 of Figures 2A and 2B and regulator 300 of Figures 3A to 3C in many respects, and may include a housing 1002, a regulator valve 1026 and a valve calibrator 1051. Housing 1002 may have an end wall 1003, one or more side walls 1001 and an open end 1005 opposite end wall 1003. Side walls 1001 can be coupled to the peripheral portions of, and generally perpendicular to, end wall 1003.
[0108] The housing 1002 can be partitioned by a wall 1004 to form a loading chamber 1008 and a filling chamber 1010. In some embodiments, the loading chamber 1008 can join with the filling chamber 1010, being arranged between the end wall 1003, the wall 1004 and the side walls 1001. The supply chamber 1010 can be arranged between the loading chamber 1008 and the open end 1005. For example, in Figure 3D, wall 1004 separates the loading chamber 1008 and the supply chamber
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1010. Supply chamber 1010 can be connected by wall 1004, side walls 1001 and open end 1005. Wall 1004 can be coupled to side walls 1001 of housing 1002 in peripheral portions of wall 1004. In some embodiments, it cannot no fluid communication occurs between loading chamber 1008 and supply chamber 1010 at locations where wall 1004 engages in housing 1002.
[0109] Enclosure 1002 and wall 1004 can be formed of a material having sufficient strength to resist sagging if reduced pressure is supplied to loading chamber 1008 and supply chamber 1010, such as metals, hard plastics or other suitable materials. For example, housing 1002 and wall 1004 can resist sagging if a reduced pressure of about 150 mm Hg (-150 mm Hg gauge pressure) is supplied to the loading chamber 1008 and the filling chamber 1010. In other embodiments For example, enclosure 1002 and wall 1004 can resist sagging if a reduced pressure of about 600 mm Hg (600 mm Hg gauge pressure) is supplied to the loading chamber 1008 and the filling chamber 1010.
[0110] Loading chamber 1008 may include a source port 1014 and a loading port 1016. Source port 1014 may be arranged on one of the side walls 1001 of loading chamber 1008 and may be fluidly coupled to the chamber loading port 1008. In some embodiments, the original port 1014 can be configured to be fluidly coupled to a reduced pressure supply, such as a pump
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46/110 electric pump, a hand pump or a wall suction source. In some embodiments, the original port 1014 can be fluidly coupled to a wall suction source by a conduit or tube. A one-way valve can be arranged on the source port 1014 and oriented to prevent the flow of fluid into the loading chamber 1008 through the source port 1014 and to allow the flow of fluid from the loading chamber 1008 out through the source port 1014.
[0111] In some embodiments, loading port 1016 can be arranged on wall 1004, as shown in the illustrative embodiment of Figure 3D. Loading port 1016 can fluidly couple loading chamber 1008 and supply chamber 1010. In some embodiments, loading port 1016 may have a cylindrical wall 1015 and a central passageway 1017 that extends between the loading chamber 1008 and the supply chamber 1010. The cylindrical wall 1015 may include a portion extending into the supply chamber 1010 from the wall 1004, so that the loading port 1016 ends at a central portion of the open end 1005. In in some embodiments, loading port 1016 may be arranged in other locations on wall 1004. In some embodiments, loading port 1016 may have a valve seat 1024 at the distal end. The valve seat 1024 can provide a tapered or beveled edge close to the central passage 1017 of loading port 1016.
[0112] The supply chamber 1010 may include a supply port 1018. In some
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In 47/110 embodiments, supply port 1018 can be fluidly coupled to supply chamber 1010 and provide an interface to supply chamber 1010. For example, supply port 1018 can be configured to be coupled to a tube, which can be attached to a bandage or other ascending component. A one-way valve can be arranged on the supply port 1018 and oriented to allow the flow of fluid into the supply chamber 1010 through the supply port 1018 and prevent the flow of fluid from the supply chamber 1010 out of the supply port 1018.
[0113] In some embodiments, open end 1005 may provide a fluid path between loading port 1016 and supply chamber 1010, which can be controlled by regulator valve 1026. Regulator valve 102 6 may include a member valve 1022 and a regulator spring 1034. The regulator valve 1026 can be coupled to the open end 1005 and operably associated with the loading port 1016 for regulating the fluid communication between the loading chamber 1008 and the filling chamber 1010 Regulator valve 1026 can be tilted to open or close loading port 1016. Regulator valve 1026 can be coupled to the ends of side walls 1001 of housing 1002, opposite to end wall 1003 of housing 1002. In In some embodiments, regulator valve 1026 can substantially limit or prevent fluid communication through open end 1005 of housing 1002.
[0114] In some modalities, the member of
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48/110 valve 1022 can be a flexible membrane, such as a diaphragm. In some embodiments, the valve member 1022 may have a generally disk-like shape with a diameter greater than the diameter of the open end 1005. In other embodiments, the valve member 1022 may have a shape corresponding to an open end shape 1005, for example, a square, rectangular, ovoid, triangular or amorphous shape. Valve member 1022 may have peripheral portions coupled to side walls 1001, and valve member 1022 may extend across the open end 1005. If valve member 1022 is coupled to side walls 1001, the member valve 1022 can fluidly isolate supply chamber 1010 from the environment surrounding regulator 1000. For example, a difference in pressures in supply chamber 1010 and the environment can cause deflection of valve member 1022. In some embodiments , the valve member 1022 may be formed of a silicone material. In some embodiments, valve member 1022 may have a hardness rating between about 100 Shore A and about 50 Shore A.
[0115] In some embodiments, valve member 1022 may include an enlarged portion 1025 configured for engagement of valve seat 1024. Valve member 1022 may be positioned so that the enlarged portion 1025 of valve member 1022 can engage a beveled edge of the valve seat 1024 of loading port 1016 in a closed position. If engaged in this way, valve member 1022 can substantially prevent fluid communication through the central passage
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1017 from loading port 1016.
[0116] Regulator spring 1034 can be arranged on loading port 1016, so that regulator spring 1034 circumscribes loading port 1016. Regulator spring 1034 can have a first end adjacent to wall 1004. In In some embodiments, the first end of regulator spring 1034 can be in contact with wall 1004, so that regulator spring 1034 can be compressed against wall 1004. A second end of regulator spring 1034 can be adjacent to the distal end of loading port 1016. Regulator spring 1034 can be of length Z if in a relaxed position. In the relaxed position, regulator spring 1034 can be longer than loading port 1016.
[0117] Valve calibrator 1051 can include a regulator cap 1032, a calibration spring 1050 and a handle 1038. Regulator cap 1032 can be coupled to housing 1002, so that regulator cap 1032 is adjacent to to the supply chamber 1010 and to the open end 1005. In some embodiments, the regulator cap 1032 covers the open end 1005 of housing 1002 and includes a raised portion extending away from the supply chamber 1010 near a center of the regulator cap 1032. In some embodiments, the raised portion may be coextensive with the open end 1005, so that the regulator cap 1032 can be separated from the valve member 1022 near the open end 1005.
[0118] In some embodiments, the 1032 regulator cover may include a calibrator installation
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1052. The 1052 calibrator installation can be a tubular portion coupled to the raised portion of the 1032 regulator cover and extending away from the supply chamber 1010. In some embodiments, the 1052 calibrator installation can be positioned on the 1032 regulator cover, so that the 1052 calibrator installation is coaxial with the 1017 loading port 1017 central passage. In other embodiments, the 1052 calibrator installation may not be coaxial with the 1016 loading port 1017 central passage. The 1052 calibrator installation may have a 1054 thread formed on the inner surface of the 1052 calibrator installation.
[0119] In some embodiments, the 1050 calibration spring can be arranged in the 1052 calibrator installation. The 1050 calibration spring can be less than an inner diameter of the 1052 calibrator installation so that the 1050 calibration spring can move axially by installing calibrator 1052. In some embodiments, one end of calibration spring 1050 may be in contact with valve member 1022 on the opposite side of valve member 1022 from regulator spring 1034. Calibration spring 1050 it may have a first end adjacent to the valve member 1022. In some embodiments, the first end of the calibration spring 1050 may be in contact with the valve member 1022 on an opposite side of the valve member 1022 with respect to the raised portion 1025, allowing calibration spring 1050 to be compressed against valve member 1022 opposite regulator spring 1034. A second end of calibration spring 1050 may extend towards the interior of the installation of
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51/110 calibrator 1052 and finish adjacent to thread 1054. Calibration spring 1050 can have a length W if it is in a relaxed position.
[0120] The 1038 handle can be a generally cylindrical body with a length and diameter. In some embodiments, the diameter of handle 1038 can be substantially the same as the inside diameter of the 1052 gauge installation. A thread 1053 can be formed on the outer surface of handle 1038. Thread 1053 of handle 1038 can be a joining thread for the thread. 1054, allowing handle 1038 to be threaded within the calibrator installation 1052. In some embodiments, handle 1038 can be positioned with one end of handle 1038 adjacent to, or in contact with, one end of calibration spring 1050.
[0121] Figure 3E is a schematic sectional view illustrating additional details that can be associated with some modalities of regulator 1000 in an open position. In some embodiments, a differential force can operate on the valve member 1022. The differential force can be a force generated by a difference in pressures between the supply chamber 1010 and the environment of regulator 1000. The pressure in the supply chamber 1010 can also be referred to as a supply pressure or intake pressure. If the supply pressure in the supply chamber 1010 and the pressure in the environment are substantially equal, the differential force can be approximately zero. If the supply pressure in the supply chamber 1010 is lower than the ambient pressure, for example, if the regulator 1000 is
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52/110 being used to provide reduced pressure therapy, the differential force can act to push valve member 1022 toward the distal end of loading port 1016.
[0122] In some embodiments, the regulator spring 1034 can exert a force in response to the movement of the regulator spring 1034 from the relaxed position. If regulator spring 1034 is arranged in supply chamber 1010, regulator spring 1034 can be moved from the relaxed position so that regulator spring 1034 has a length Ζχ. If regulator spring 1034 is compressed to length Ζχ, regulator spring 1034 can exert a regulator force by pushing valve member 1022 away from valve seat 1024 of loading port 1016. Generally, the regulator force exerted on the valve member 1022 it can be proportional to the distance by which the regulator spring moves from the relaxed position. Generally, regulator spring 1034 can be selected so that the differential force can overcome the regulator force if the supply pressure is approximately the therapy pressure. If the differential force exceeds the regulator force, valve member 1022 may come into contact with loading port 1016 and prevent fluid communication through loading port 1016.
[0123] In some embodiments, the calibration spring 1050 can exert a force in response to the movement of the calibration spring 1050 from the relaxed position. If the 1050 calibration spring is arranged in the 1052 calibrator installation, the
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53/110 calibration 1050 can be moved from the relaxed position so that the calibration spring 1050 can have a length Wi. If calibration spring 1050 is compressed to length Wi, calibration spring 1050 can exert a calibration force by pushing valve member 1022 toward valve seat 1024 of loading port 1016. Generally, the force exerted on the member valve 1022 can be proportional to the distance by which the calibration spring 1050 moves from the relaxed position. In some embodiments, the force of the regulator spring 1034 and the force of the calibration spring 1050 can push the valve member 1022 in opposite directions.
[0124] In some embodiments, the calibration spring 1050 can exert a force that helps the differential force to push the valve member 1022 into contact with the valve seat 1024 of the loading port 1016. The force exerted by the pressure spring calibration 1050 can be used to calibrate regulator 1000 to the desired therapy pressure. For example, regulator 1000 can be tested to determine whether regulator 1000 provides reduced pressure at a desired therapy pressure without any calibrating force. If regulator 1000 fails to deliver therapy pressure, handle 1038 can be threaded further into the 1052 calibrator installation to increase the calibration force applied by calibration spring 1050. In other embodiments, if regulator 1000 has already been calibrated, regulator 1000 can be tested to determine whether regulator 1000 provides reduced pressure at a desired therapy pressure. If regulator 1000 provides insufficient reduced pressure, handle 1038 can be unscrewed
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54/110 of the 1052 calibrator installation to decrease the calibration force applied by the 1050 calibration spring, thereby increasing the differential force required to overcome the regulator force.
[0125] Figure 3F is a schematic sectional view illustrating additional details of regulator 1000 in a closed position. If the differential force plus the calibration force are greater than the force of the regulator spring 1034 acting on the valve member 1022, the valve member 1022 can be pushed to contact the distal end of the loading port 1016 to prevent communication flowed through loading port 1016 in a closed position. In response, the regulator spring 1034 can be compressed to a length Z ₂ . If the differential force plus the calibration force are less than the force of the regulator spring 1034, the valve member 1022 can be pushed away from the distal end of the loading port 1016 to allow fluid communication through the loading port 1016 in the open position. , shown in Figure 3E. The handle 1038 can be threaded by the thread 1054 to control the differential force required to overcome the regulator spring 1034. For example, if less reduced pressure is required, the handle 1038 can be threaded inside the calibration installation 1052, so that the 1050 calibration spring has a length W ₂ . In this way, the displacement of the calibration spring 1050 can be controlled to calibrate the differential pressure, so that the force of the regulator spring 1034 can be overcome if the therapy pressure is reached in the supply chamber 1010.
[0126] REDUCED PRESSURE THERAPY SYSTEM
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[0127] Figure 4A 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 example embodiment of the reduced pressure therapy system 100. The reduced pressure system 400 includes a reduced pressure source 402, a Container 403 and a bandage 404. The reduced pressure source 402 can be a wall suction source, a hand pump or an electric pump, for example. In some embodiments, 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 406 can fluidly couple fluid to the reduced pressure source 402 at the source port. 314, as shown in the illustrative embodiment of Figure 4A. Container 403 is an example embodiment of Container 112, and can be fluidly coupled to supply port 318. In some embodiments, for example, a tube 410 can fluidly couple Container 403 to supply port 318. Container 403 can include a filter, such as a hydrophobic filter 414 adjacent to an end of tube 410. Bandage 404 is an example embodiment of bandage 102, and can be fluidly attached to Container 403. For example, a tube 412 can fluidly attach bandage 404 in Container 403. Bandage 404 may have a pressure which can also be referred to as an inlet pressure. In some embodiments, tube 410 and tube 412 may each have at least one lumen. The at least one lumen in tube 410 and tube 412 can be collectively referred to as a supply lumen. In
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56/110 other modalities, Container 403 can be omitted, and tube 410 can be coupled directly to bandage 404. In these modalities, the at least one lumen in tube 410 can be considered a supply lumen. Bandage 404 can also be fluidly attached to control port 321. For example, a tube 408 can fluidly attach bandage 404 to control port 321. In some embodiments, 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.
[0128] Bandage 404 can be fluidly coupled to supply port 318 and control port 321, so that fluid communication can take place between supply chamber 310 and bandage 404 through Container 403, and between bandage 404 and the control chamber 312. Fluid communication between band 404, supply chamber 310 and control chamber 312 can equalize the pressures in supply chamber 310, bandage 404 and control chamber 312. For example, communication fluid between bandage 404, supply chamber 310 and control chamber 312 can equalize the supply pressure in supply chamber 310, the intake pressure in bandage 404 and the control pressure in control chamber 312. If the port source 314 is not coupled to the reduced pressure source 402, loading port 316 can remain open and ambient pressure can equalize between loading chamber 308, supply chamber 310, band gem 404 and the control chamber 312.
[0129] In some embodiments, monitoring port 323 and monitoring port 319 can be
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57/110 fluidly coupled. For example, a tube, such as a tube 415 can fluidly couple the monitoring port 319 to the monitoring port 323. In some embodiments, the tube 415 can provide a fluid path between the monitoring port 323 and the monitoring port 319. In other embodiments, tube 415 can provide fluid communication between monitoring port 323 and monitoring port 319. In still other embodiments, tube 415 can provide both fluid communication and a fluid path between the monitoring port 323 and the monitoring port 319.
[0130] The reduced pressure source 402 can be coupled to the source port 314, providing reduced pressure to loading chamber 308. If regulator valve 326 is in the open position, loading port 316 provides a fluid path between the loading chamber 308 and the filling chamber 310. While the reduced pressure supply reduces the pressure within the loading chamber 308, the pressure in the supply chamber 310 may similarly drop. The pressure in the supply chamber 310 can also be referred to as a supply pressure. Fluid communication through supply port 318 will similarly lower pressure in bandage 404, and fluid communication through control port 321 may similarly begin to lower pressure in control chamber 312. As the control pressure in the control chamber 312 falls, the differential force acting in opposition to the force of the regulator spring 334 increases, eventually exceeding the force of the regulator spring 334, causing the stem 328 to move downward and forcing the regulator valve 32 6 to the closed position in which the member of
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58/110 valve 322 is placed on loading port 316. In the closed position, valve member 322 can obstruct fluid communication through loading port 316. Reductions in reduced pressure in bandage 404 can decrease the differential force, so that the inclination force of regulator spring 334 exceeds the differential force to open regulator valve 326. In the open position, fluid communication through loading port 316 can be resumed until pressure in bandage 404, and in turn in the control chamber control 312, drop sufficiently to overcome the regulator spring 334, closing regulator valve 326 again. Repeated opening and closing of regulator valve 326 may occur while reduced pressure therapy is provided.
[0131] In some embodiments, the central passage 317 can be calibrated to provide a leak indicator in the 400 system. For example, a known diameter of the central passage 317 can be correlated with a rate at which the reduced pressure drops if there is a leak. in the system 400. By controlling the diameter of the central passage 317, a pressure indicator attached to the system 400 can be calibrated to trigger at a reduced pressure associated with the rate at which the reduced pressure drops if there is a leak. In some embodiments, the known diameter of the central passage 317 which can be about 0.45 mm. In some embodiments, the central passage 317 can control the rate at which the reduced pressure drops if there is a leak in the system coupled to regulator 300. In some embodiments, the height of the loading port 316 can also be used.
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[0132] Figure 4C is a schematic illustration of a reduced pressure system 1100 illustrating additional details that may be associated with the operation of some modalities of regulator 1000. The reduced pressure system 1100 is an example of the pressure therapy system reduced 100 and can be similar or analogous to the reduced pressure system 400 in many ways. For example, the reduced pressure system 1100 may include the reduced pressure source 402, Container 403 and bandage 404. Tube 406 can fluidly couple the reduced pressure source 402 to source port 1014, as shown in the illustrative embodiment of Figure 4C. Container 403 can be fluidly attached to supply port 1018. In some embodiments, tube 410 can fluidly attach Container 403 to supply port 1018. Tube 412 can fluidly attach banding 404 to Container 403. In some embodiments, the bandage 404 may include a fluid connection that allows pressure to be measured in bandage 404. For example, tube 408 may be fluidly attached to bandage 404. In some embodiments, tube 408 may have a cap 423 at an opposite end of the tube 408 in relation to bandage 404. Cap 423 can prevent fluid communication through the end of tube 408.
[0133] Bandage 404 can be fluidly coupled to supply port 1018 so that fluid communication can take place between supply chamber 1010 and bandage 404 by Container 403. Fluid communication between bandage 404 and supply chamber 1010 can equalize pressures in supply chamber 1010 and bandage 404. If the source port
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1014 is not coupled to the reduced pressure source 402, loading port 1016 can remain open and ambient pressure can equalize between loading chamber 1008, supply chamber 1010 and bandage 404.
[0134] The reduced pressure source 402 can be coupled to the source port 1014, providing reduced pressure to loading chamber 1008. If regulator valve 1026 is in the open position, loading port 1016 provides a fluid path between the loading chamber 1008 and the filling chamber 1010. While the reduced pressure supply reduces the pressure within the loading chamber 1008, the pressure in the supply chamber 1010 may similarly drop. Fluid communication through supply port 1018 will similarly lower the pressure in bandage 404. As the supply pressure in supply chamber 1010 drops, the differential force acting in accordance with the force of the calibration spring 1050 and in opposition to the force regulator spring 1034 may increase. The differential force can overcome the force of the regulator spring 1034, causing the valve member 1022 to move down and to the closed position. In the closed position, valve member 1022 can be placed on loading port 1016. In closed position, valve member 1022 can obstruct fluid communication through loading port 1016. Reductions in reduced pressure in bandage 404 can decrease force differential, so that the inclination force of regulator spring 1034 exceeds the differential force and calibration force of calibration spring 1050 to open regulator valve 1026. In the
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61/110 open position, fluid communication through loading port 1016 can be resumed until pressure in bandage 404 drops sufficiently to overcome regulator spring 1034, closing regulator valve 1026 again. Repeated opening and closing of the control valve regulator 1026 may occur while reduced pressure therapy is provided.
[0135] BACKPACKING INTERFACES
[0136] The reduced pressure system 400 or the reduced pressure system 1100 can also provide feedback to an operator. For example, the reduced pressure system 400 or the reduced pressure system 1100 may include one or more feedback interfaces to signal that the reduced pressure is being applied within a prescribed range. A feedback interface can also indicate other conditions, such as an overpressure condition, a leakage condition or an obstruction condition. In some embodiments, feedback can include audible feedback, visual feedback, tactile feedback or any combination thereof. A feedback interface can include an indicator, meter or signal, for example.
[0137] A feedback interface can be coupled or arranged in the reduced pressure system 400 or in the reduced pressure system 1100, or the combinations of feedback interfaces can be distributed in various locations throughout the reduced pressure system 400 or the 1100 reduced pressure system. In some embodiments, a feedback interface can be coupled in-line to a tube or other fluid path in the
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62/110 reduced pressure system 400 or reduced pressure system 1100. For example, the reduced pressure system 400 or reduced pressure system 1100 may include a feedback interface coupled to a tube 410 at a location 416, which is between supply port 318 or supply port 1018 and Container 403. Additionally or alternatively, a feedback interface can be coupled to a tube 412 at a location 418 between Container 403 and bandage 404. A feedback interface it can also be coupled to a tube 408 at a location 420 between bandage 404 and control port 321. In one embodiment of Figure 4C, location 420 may correspond to a fluid coupling in bandage 404 independent of regulator 1000. In some embodiments , a feedback interface can be coupled to the reduced pressure system 400 at a location 430 between the reduced pressure source 402 and the source port 31 4 or between the reduced pressure source 402 and the source port 1014.
[0138] A feedback interface can also be coupled to more than one fluid path in some modalities. For example, a feedback interface at location 416 can be fluidly coupled to a T-piece which can, in turn, be fluidly coupled to at least two between supply port 318, tube 410 and Container 403. In still other embodiments, tube 410 can be fitted so that a feedback interface at location 416 can be fluidly coupled to tube 410. Similarly, a feedback interface at location 418 can be fitted
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63/110 fluidly coupled in line between bandage 404 and Container 403. A feedback interface at location 420 can be fluidly coupled in line between bandage 404 and control port 321 of regulator 300, and the feedback interface at location 430 can be fluidly coupled in line between the reduced pressure source 402 and the source port 314 of regulator 300 or source port 1014 of regulator 1000.
[0139] In some embodiments, the reduced pressure system 400 may also include a feedback interface at location 424, location 426, location 428 or various combinations thereof. A feedback interface can be positioned at location 426, for example, between monitoring port 319 and monitoring port 323. A feedback interface can also be positioned at location 424 between monitoring port 323 and a feedback interface 426. A feedback interface can be positioned at location 428 between a feedback interface 426 and monitoring port 319. A feedback interface at location 426 can be fluidly coupled to the feedback interfaces at location 424 and location 428 in one way. similar to that described above with respect to a feedback interface at location 416.
[0140] A flow indicator is an example modality of a feedback interface that can be used in the illustrative modalities of the reduced pressure system 400 or the reduced pressure system 1100. For example, a flow indicator can be implemented in the
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64/110 location 416, location 418, location 420, location 424, location 426, location 428 or location 430. In some embodiments, a flow indicator is a mechanical flow indicator that can provide audible feedback, visual or tactile fluid movement. Figure 4B is a schematic sectional view of an example embodiment of an audible flow indicator 417. In the illustrated embodiment, the audible flow indicator 417 is a T-piece with a first fluid passage 419 extending through the T-piece and a second fluid passage 421 intersecting the first fluid passage 419. The fluid flow through the first fluid passage 419 can induce a fluid flow through the second fluid passage 421. The second fluid passage 421 can be sized so that, if the fluid flow through the first fluid passage 419 exceeds a predetermined flow rate, the fluid flow induced by the second fluid passage 421 can produce an audible sound. In some embodiments, the first fluid passage 419 and the second fluid passage 421 are sized so that the audible sound is produced if a leak in the reduced pressure system 400 or in the reduced pressure system 1100 causes the air flow audible flow indicator 417 exceeds a threshold flow rate. The audible flow indicator 417 can be calibrated so that the threshold flow rate corresponds to leaks that interfere with or prevent the therapeutic application of reduced pressure. For example, a leak in bandage 404 can cause regulator 300 to provide a greater flow of reduced pressure. If the flow indicator at location 420 is an audible flow indicator 417, the
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65/110 Higher flow through location 420 can induce an audible sound, such as a whistle, alerting an operator of a leak condition that may require corrective action.
[0141] A pressure gauge is another example of a feedback interface that can be used in the illustrative mode of the reduced pressure system 400 or the reduced pressure system 1100. For example, a mechanical pressure gauge can be arranged at location 416, at location 418, location 420, location 424, location 426, location 428 or location 430. In general, a manometer is a device configured for determining and displaying a pressure in fluid communication with the manometer. In this way, a mechanical pressure gauge can provide visual feedback to the operating state of the reduced pressure system 400 or reduced pressure system 1100.
[0142] In some embodiments, regulator 300 can also be a feedback interface. For example, a leak condition generally causes the regulator valve 326 to reciprocate between an open and closed position as it tries to compensate for the leak. The frequency of the reciprocating motion is generally proportional to the severity of the leak condition. At higher frequencies, the reciprocating motion can provide tactile feedback. Actuator 330 can also provide audible feedback at higher frequencies. In this way, regulator 300 can provide a proportional leakage alarm.
[0143] Figure 5A is a perspective view of an example embodiment of a 500 pressure gauge.
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66/110 pressure indicator 500 is another example of a feedback interface that can be used to provide visual pressure feedback in the illustrative mode of the reduced pressure system 400 or the reduced pressure system 1100. In some embodiments, pressure indicator 500 can be arranged at any one or more between location 416, location 418, location 420 or location 424. As illustrated in Figure 5A, some embodiments of pressure indicator 500 can be formed with a side wall 502 and a head 504. The side wall 502 can be a folding wall that has a first end coupled to the head 504 and a second end opposite the head 504. The head 504 can be round, as shown in Figure 5A, or it can have other shapes, such as a square, triangular or amorphous shape.
[0144] Figure 5B is a side view of pressure indicator 500, illustrating additional details that may be associated with some modalities. For example, the pressure indicator 500 may have an end wall 506 coupled to the side wall 502 opposite the head 504. If the end wall 506 is coupled to the side wall 502 opposite the head 504, the end wall 506, the head 504 and side wall 502 can collectively form pressure indicator 500. Pressure indicator 500 may also include a port 508 in some embodiments. Port 508 can be arranged on side wall 506 near a center of side wall 506. Port 508 can be configured to fluidly couple pressure indicator 500 to other devices, such as tube 410,
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67/110 tube 412 or the monitoring port 323.
[0145] Figure 5C is a sectional view of pressure indicator 500, illustrating additional details that may be associated with some modalities. As illustrated, the head 504, the side wall 502 and the end wall 506 can be coupled to form a chamber 510 within the pressure indicator 500. In some embodiments, port 508 can supply a fluid path to the chamber 510. Sidewall 502 may have a convex interior surface and may include deflectors or other features.
[0146] Pressure indicator 500, including side wall 502, head 504 and end wall 506, can be formed from a soft medical grade polymer or other foldable material. As non-limiting examples, pressure indicator 500 can be formed from polyurethane, polyethylene, polyvinyl chloride (PVC), fluorosilicone, ethylene-propylene, etc. In some embodiments, the pressure indicator 500 can be molded from bis (2ethylhexyl) phthalate (DEHP) free PVC. Pressure indicator 500 can be molded, cast or extruded, and can be formed as an integral unit.
[0147] Figure 5D is a side view of pressure indicator 500, illustrating additional details that may be associated with some modalities. In operation, the reduced pressure through port 508 can bend the side wall 502 if the reduced pressure in chamber 510 exceeds a threshold pressure. The thickness, stiffness and geometry of the sidewall 502 are variables that can impact the threshold pressure at which the sidewall 502 bends. While the thickness of the sidewall 502 can be determined using the
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68/110 finite element analysis, it may be necessary to determine the wall thickness empirically to achieve movement at the threshold pressure.
[0148] In some embodiments, the side wall 502 can be designed so that the side wall 502 bends as the pressure in chamber 510 drops below the threshold pressure. If the side wall 502 yields, the head 504 can move from a first position, also referred to as an extended position, as shown in Figure 5B, to a second position, also referred to as a retracted position, as shown in Figure 5D. The side wall 502 of the pressure indicator 500 can be of a size and shape to bend or move the head 504 so that it is adjacent to the end wall 506 if threshold pressure is reached. If the pressure in chamber 510 remains or increases above the threshold pressure, side wall 502 can return to the extended position of Figure 5B. For example, pressure indicator 500 can be calibrated so that the threshold pressure is equal to or less than a therapy pressure. In this way, the pressure indicator 500 can provide a binary visual feedback for the therapeutic pressure state in a reduced pressure system, such as the reduced pressure system 400 or the reduced pressure system 1100.
[0149] In some embodiments, pressure indicator 500 can be coupled to tube 410 at location 416, between supply port 318 and Container 403. For example, pressure indicator 500 at location 416 can indirectly indicate that pressure of therapy was reached in supply chamber 310 and Container 403.
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Similarly, pressure indicator 500 can be arranged at location 418 to indicate that the therapy pressure has been reached in supply chamber 310, Container 403 and bandage 404. If pressure indicator 500 is located at location 420, the assignment of pressure indicator 500 may indicate that the therapy pressure has been reached in supply chamber 310, Container 403, bandage 404 and control chamber 312. If pressure indicator 500 is located at location 428, the assignment of the pressure indicator 500 can indicate that the therapy pressure has been reached in the supply chamber 310.
[0150] Pressure indicators can also be used to indicate an obstruction condition. For example, a first pressure indicator 500 can be coupled fluidly at location 416 and a second pressure indicator 500 can be coupled at location 418. An obstruction condition in Container 403, tube 410 or tube 412 can be indicated if the first pressure indicator 500 is folded, but the second pressure indicator 500 is extended. Pressure indicators can also be used to indicate leaks. For example, a first pressure indicator 500 can be coupled fluidly at location 418 and a second pressure indicator 500 can be coupled at location 420. A leak condition, such as a leak in bandage 404, can be indicated if the first pressure indicator 500 is folded, but the second pressure indicator 500 is extended.
[0151] Figure 6A is a sectional view
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70/110 schematic of a pressure indicator 600 that can be used with some modalities of the reduced pressure system 400 or the reduced pressure system 1100. Figure 6B is a schematic side view of the pressure indicator 600, illustrating additional details that may be associated with some modalities. Pressure indicator 600 is another example modality of a feedback interface that can be used to provide visual pressure feedback in the illustrative modality of the reduced pressure system 400 or the reduced pressure system 1100. In some embodiments, the pressure indicator 600 can be arranged in any one or more between location 416, location 420, location 424, location 428 or location 430. As illustrated in Figure 6A and Figure 6B, pressure indicator 600 may have a housing 602 Enclosure 602 can be tubular and have an end wall 601. The peripheral portions of end wall 601 can be coupled at one end of a side wall 605. Enclosure 602 can have an open end 603 opposite end wall 601 The housing 602 may also have a chamber 608, a door 620 formed on the end wall 601 of the housing 602, and a window 622 formed on the side wall 605 close to the open end 603 of housing 602. In some embodiments illustrated in Figure 6A, chamber 608 is generally defined by, and formed within, end wall 601 and side wall 605. Port 620 can be configured to fluidly couple the pressure indicator 600 in other devices, such as tube 410 or monitoring port 319. In some embodiments, port 620 can supply a fluid path to chamber 608.
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[0152] Pressure indicator 600 may also have a diaphragm 604 arranged inside chamber 608. Diaphragm 604 may have peripheral portions engaged in a sealed manner in housing 602. For example, peripheral portions of diaphragm 604 may be anchored to the side wall 605. In some embodiments, a central portion of diaphragm 604 can be configured to move in relation to the peripheral portions of diaphragm 604. The movement may be parallel to side wall 605, for example. Diaphragm 604 can substantially prevent fluid transfer from side to side of diaphragm 604 to fluidly seal at least a portion of chamber 608. Diaphragm 604 may be formed of a material with an elasticity to allow elastic deformation of the diaphragm 604. In some embodiments, diaphragm 604 can be formed by a silicone, for example. In some embodiments, diaphragm 604 can have a hardness between about 30 Shore A and about 50 Shore A.
[0153] Pressure indicator 600 may also include a plunger 609 disposed within housing 602. Some embodiments of plunger 609 may include a stem 610 and a cap 612, for example. The stem 610 can be cylindrical in some embodiments. The stem 610 can pass through a hole in diaphragm 604. In some embodiments, stem 610 can be coupled to diaphragm 604. In some embodiments, for example, stem 610 can be coupled to a central portion of diaphragm 604 and can be fluidly sealed in diaphragm 604. In some embodiments, the movement of the central portion of diaphragm 604 can also cause stem 610 to move in the same direction.
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[0154] The cap 612 can be attached to one end of the stem 610. The cap 612 may be cylindrical in some embodiments and may be larger than the corresponding dimension of the stem 610. In other embodiments, the large dimension of the cap 612 it can be the same as the dimension of the rod 610. The plunger 609 can also have indicator rings in some embodiments. For example, cover 612 can include a first ring 614, a second ring 616 and a third ring 618, as shown in Figure 6A. In some embodiments, the first ring 614 can be positioned adjacent to one end of the stem 610, the second ring 616 can be positioned adjacent to the first ring 614, and the third ring 618 can be positioned adjacent to the second ring 616. In some embodiments, the first ring 614, the second ring 616 and the third ring 618 are stacked parallel to the side wall 605. In some embodiments, the first ring 614, the second ring 616 and the third ring 618 they may be integral with stem 610 or coax with stem 610. In some embodiments, the first ring 614, the second ring 616 and the third ring 618 can be marked with different colors. For example, the first ring 614 can be red, the second ring 616 can be green and the third ring 618 can be black. In some embodiments, the lid 612 may be arranged within the housing 602, so that at least a portion of the lid 612 is visible through the window 622. Preferably, at least one between the first ring 614, the second ring 616 or the third ring 618 is also visible through window 622.
[0155] Pressure indicator 600 may also have a tilt member, such as a
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73/110 spring 606, arranged in chamber 608. In some embodiments, spring 60 6 can be arranged in chamber 608 between end wall 601 of housing 602 and diaphragm 604. In some embodiments, spring 606 may have a first engaged end or coupled to diaphragm 604 and a second engaged end or else coupled to end wall 601 adjacent to port 620. Spring 606 can be positioned so that spring 60 6 can be compressed against end wall 601 of housing 602 by diaphragm 604. In some embodiments, a portion of stem 610 between diaphragm 604 and end wall 601 of housing 602 may be at least partially circumscribed by spring 606.
[0156] In operation, port 620 can be fluidly coupled to a source of reduced pressure, exposing port 620 and chamber 608 to reduced pressure. The pressure in chamber 608 may decrease in response to the application of reduced pressure until the pressure in chamber 608 is in equilibrium with the reduced pressure fluidly coupled to port 620. The pressure in chamber 608 may exert a force on a first side of diaphragm 604 facing chamber 608. Similarly, ambient pressure can exert a force on an opposite side of diaphragm 604 through the open end 603 of housing 602. The sum total of forces acting on diaphragm 604 due to differential pressures on opposite sides of diaphragm 604 can be referred to as a differential force. Generally, if a reduced pressure is supplied to chamber 608, the differential force pushes diaphragm 604 towards port 620. The differential force can be countered by a spring force exerted on the
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74/110 diaphragm 604 by spring 606. The spring force can be proportional to a spring constant of spring 60 6 and to a distance at which spring 60 6 can be compressed by diaphragm 604.
[0157] Thus, changes in pressure within chamber 608 can trigger diaphragm 604, which in turn can cause plunger 60 9 to slide or otherwise move within housing 602. As plunger 60 9 moves moves within housing 602, the portions of plunger 60 9 that are visible within window 622 can change to indicate various operating states of a reduced pressure system. For example, the spring force of the spring 606 can be selected so that a prescribed pressure pushes the diaphragm 604 towards the end wall 601, compressing the spring 606 by a first distance Y. The movement of the diaphragm 604 towards the wall end 601 can also move the stem 610 and the cap 612 towards the end wall 601. In some embodiments, the second ring 616 and the window 622 may be sized so that the second ring 616 is aligned with the window 622 if spring 60 6 is compressed by distance Y, as shown in Figure 6A and Figure 6B, to indicate that the prescribed pressure is being applied.
[0158] Figure 7A is a schematic sectional view illustrating additional details that can be associated with some modalities of pressure indicator 600. Figure 7B is a schematic side view of pressure indicator 600 in Figure 7A. If port 620 is exposed to a reduced pressure that is lower than the therapy pressure, the differential force acting on diaphragm 604 may be less than the spring force acting on diaphragm 604, allowing the
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75/110 spring 60 6 is in a balanced position and not compressed. Plunger 60 9 can be configured so that the first ring 614 is visible through window 622 if spring 606 is in the equilibrium position, as shown in Figure 7B. In some embodiments, for example, the first ring 614 may be red to signal an under pressure or a leak condition if visible through window 622.
[0159] Figure 8A is a schematic sectional view illustrating additional details that can be associated with some modalities of pressure indicator 600. Figure 8B is a schematic side view of pressure indicator 600 in Figure 8A. If port 620 is exposed to a reduced pressure that exceeds the therapy pressure, the differential force acting on diaphragm 604 can push diaphragm 604 towards end wall 601, compressing spring 606 by a second distance Z. The second distance Z can be greater than the first distance Y. The movement of the diaphragm 604 can also move the stem 610 and the cap 612 towards the end wall 601. The plunger 60 9 can be configured so that the third ring 618 is visible through the window 622 if the spring is compressed by the second distance Z, as shown in Figure 8B. In some embodiments, for example, the third ring 618 may be black to signal an overpressure condition.
[0160] The size of window 622 and the dimensions of the first ring 614, the second ring 616 and the third ring 618 can also be configured so that only the second ring 616 is visible within the window 622 if the reduced pressure is within an acceptable variation or tolerance of the prescribed therapy pressure. In
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In some embodiments, for example, the window 622 may be thinner than the second ring 616, so that the plunger 609 can move within the housing 602 for some distance before the first ring 614 or the third ring 618 becomes. find also visible within window 622. For example, a therapy pressure of -120 mm Hg may be prescribed, but pressure 10 mm Hg above or below the therapy pressure may be beneficial or acceptable under certain treatment conditions. Thus, in some embodiments, window 622 may be one size so that only the second ring 616 is visible if the pressure in chamber 608 is within the therapeutic range of -130 mm Hg to -110 mm Hg.
[0161] Pressure indicator 600 can be used in some modality of the reduced pressure system 400 or the reduced pressure system 1100 to provide a signal with respect to the operating status of the reduced pressure system 400 or the reduced pressure system 1100 For example, if pressure indicator 600 is located at location 416, pressure indicator 600 can signal the operating status of the reduced pressure system 400 between the supply chamber 310 and Container 403. Some modalities of the pressure system reduced pressure 400 or reduced pressure system 1100 may have more than one pressure indicator 600 to signal different operating states of the reduced pressure system 400 or reduced pressure system 1100. For example, in some embodiments, a first pressure indicator pressure 600 can be arranged in location 416 and a second pressure indicator 600 can be arranged in location 418. If the first pressure indicator the 600 signal an overpressure condition and the
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77/110 second pressure indicator 600 signals a leak condition, Container 403 may be full or there may be an obstruction condition between location 416 and location 418.
[0162] Figure 9A is a schematic sectional view of a pressure indicator 700 that can be used with some modalities of the reduced pressure system 400 or the reduced pressure system 1100. Figure 9B is a schematic side view of the pressure indicator 700. The pressure indicator 700 is another example of a feedback interface that can be used to provide visual pressure feedback in the illustrative mode of the reduced pressure system 400 or reduced pressure system 1100. In some embodiments, the indicator pressure 700 can be arranged in any one or more between location 416, location 420, location 424, location 428 and location 430. In some embodiments, pressure indicator 700 may have a housing 702 and a valve 724 , as illustrated in Figure 9A. Pressure indicator 700 may be similar to, and operate in, the manner described above with respect to pressure indicator 600 of Figures 6A to 8B.
[0163] In some embodiments, valve 724 may be an overpressure valve arranged within plunger 70 9. Plunger 70 9 may include a stem 710 and a cap 712, and stem 710 may include a cavity 732. The cavity 732 may be cylindrical and extend over a length of stem 710. In some embodiments, cavity 732 may be in fluid communication with chamber 708 through a passage 731. Passage 731 may be formed in one
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78/110 end of stem 710 which is opposite cover 712. Cavity 732 can also be in fluid communication with the ambient atmosphere through a passage 730. Passage 730 can extend from cavity 732 through cover 712. Valve 724 it may further include a valve spring 726 and a valve member 728. The valve spring 726 may be positioned in cavity 732. In some embodiments, the valve spring 726 may have a first end positioned adjacent to the passage 731. Valve spring 726 may have a second end near cover 712. Valve spring 726 can be configured to be compressed against the end of cavity 732. Valve member 728 can be arranged within cavity 732 and positioned between one end of valve spring 726 and cover 712. In some embodiments, valve member 728 may be of a size to block passage 730 if valve member 728 is positioned adjacent to passage 730. In some embodiments, valve member 728 may be sized to allow fluid communication around valve member 72 8 if valve member 728 is separated from passage 730.
[0164] Generally, pressure indicator 700 can function as described above with respect to pressure indicator 600 of Figures 6A to 8B to indicate one or more operating states of a reduced pressure system. For example, pressure indicator 700 may indicate the application of a prescribed therapy pressure, as shown in Figure 9A and Figure 9B; a leak condition, as illustrated in Figure 10A and Figure 10B; an obstruction condition, a full vessel condition or an overpressure condition,
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79/110 as illustrated in Figure 11A and Figure 11B.
[0165] In addition, pressure indicator 700 can provide pressure relief through valve 724. Pressure in chamber 708 can exert a force on one side of valve member 728 facing cavity 732. Ambient pressure can exert a force on one side of the valve member 728 through the passage 730. The valve spring 726 can also exert a spring force on the valve member 728. The spring force can be proportional to a spring constant of the valve spring 72 6 and the a distance by which the valve spring 72 6 is compressed from an equilibrium position. In this way, changes in pressure within chamber 708 may cause valve member 72 8 to slide or move within cavity 732. For example, the spring force of valve spring 72 6 can be selected so that a reduced pressure equal to or less than the therapy pressure, push the valve spring 72 6 towards the passage 730 so that the valve 724 is in the closed position, as illustrated in Figure 9A and Figure 10A. The spring force of valve spring 72 6 can also be selected so that a reduced pressure that exceeds the therapy pressure pushes valve member 728 away from passage 730 so that valve 724 is in an open position, as illustrated in Figure 11A.
[0166] If valve 724 is in an open position, as in Figure 11A, fluid communication can occur between the environment and chamber 708. For example, fluid can circulate through passage 730 around valve member 728 and into cavity 732. The fluid can circulate from cavity 732 through passage 731 inward
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80/110 of chamber 708. The fluid can also circulate from chamber 708 through port 720. In this way, an overpressure condition can be relieved by an influx of ambient pressure into chamber 708. In some embodiments, the pressure indicator 700 may include a filter arranged over passage 730. The filter may be a bacteria filter, a dust filter or a moisture filter, for example. In some embodiments, the pressure indicator 700 can also provide audible feedback for an overpressure condition, since the fluid circulating through passage 730 can produce a whistle or other audible vibration.
[0167] Figure 12A is a schematic sectional view of a pressure indicator 800 that can be used with some embodiments of the reduced pressure system 400 in Figure 4A or the reduced pressure system 1100 in Figure 4C. Pressure indicator 800 is another example of a feedback interface that can be used to provide visual pressure feedback in the illustrative mode of reduced pressure system 400 or reduced pressure system 1100. In some embodiments, for example, pressure indicator 800 can be arranged at location 426 of reduced pressure system 400 to provide visual feedback for an obstructed condition. Pressure indicator 800 may include a housing 802 with an end wall 804 and an open end 803. The open end 803 may be opposite the end wall 804. In some embodiments, the housing 802 may be cylindrical. In other modalities, the 802 casing may have other formats, such as
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81/110 cuboid or pyramidal. A partition 806 with an opening 807 can be arranged in housing 802. In some embodiments, partition 806 can be positioned between end wall 804 and open end 803. Partition 806 can have peripheral portions coupled to housing 802. In some embodiments, partition 806 may allow fluid to flow into housing 802 through opening 807.
[0168] The housing 802 may have two contiguous chambers separated by a diaphragm, such as a first chamber 814 and a second chamber 815 separated by a diaphragm 816. The diaphragm 816 may have peripheral portions coupled in the housing 802 and may be substantially impermeable transmission of gas and liquid. In some embodiments, diaphragm 816 can fluidly separate first chamber 814 and second chamber 815. In some embodiments, diaphragm 816 may be a fluid barrier that prevents the flow of fluid between first chamber 814 and second chamber 815 within the 802 enclosure.
[0169] The first chamber 814 can join the end wall 804, and the second chamber 815 can be adjacent to the open end 803. In some embodiments, partition 806 can be arranged in the second chamber 815. In some embodiments, partition 806 can be arranged between diaphragm 816 and open end 803. A port 810 can be fluidly coupled to the first chamber 814, and a port 812 can be fluidly coupled to the second chamber 815. Port 810 can provide a fluid pathway up to the first chamber 814, and port 812 can provide a fluid path to the second chamber 815.
[0170] The 816 diaphragm can be formed by a
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82/110 material with an elasticity to allow elastic deformation of diaphragm 816. In some embodiments, diaphragm 816 can be formed by a silicone, for example. In some embodiments, the 816 diaphragm can have a hardness between about 30 Shore A and about 50 Shore A.
[0171] A stem 818 can be coupled to diaphragm 816 and extend away from diaphragm 816 through the second chamber 815. The stem 818 can be cylindrical. In some embodiments, stem 818 may have a dimension, such as a diameter, that is less than one dimension of aperture 807. An upper end of stem 818 may pass through aperture 807. In some embodiments, stem 818 may have a first end coupled to diaphragm 816 and a second end disposed between partition 806 and open end 803.
[0172] A cap 820 can be attached to the second end of stem 818 which is opposite diaphragm 816. In some embodiments, cap 820 can be arranged between partition 806 and open end 803. Cap 820 can be cylindrical. In some embodiments, the lid 820 may have a dimension, such as a diameter, that is greater than the opening 807. If the dimension of the lid 820 is greater than the dimension of the opening 807, the lid 820 may not pass through the opening 807 A central portion of diaphragm 816, stem 818 and cap 820 can be rigidly coupled to each other so that the movement of one causes the movement of the others in the same direction.
[0173] The cover 820 may have indicator rings, such as a first ring 822 and a second ring 824. In some embodiments, the first ring 822 and the second ring
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824 can be configured as layers in the cap 820, so that the second ring 824 is coupled to the end of the stem 818 and the first ring 822 is coupled to the second ring 824, for example. In other embodiments, the first ring 822 and the second ring 824 may be marked on the surface of the lid 820. In some embodiments, the first ring 822 and the second ring 824 of the lid 820 may be of different colors. For example, in some embodiments, the first ring 822 may be green, and the second ring 824 may be red. In other embodiments, the first ring 822 may have another color, such as red, yellow, blue or black. Similarly, in other embodiments, the second ring 824 can be green, yellow, blue or black, for example.
[0174] The pressure indicator 800 can also have a tilt member, such as a spring 819, for example, arranged in the second chamber 815. The spring 819 can have a first end engaged in diaphragm 816 and a second end engaged in partition 806. In some embodiments, spring 819 can be compressed between partition 806 and diaphragm 816. In some embodiments, stem 818 can be circumscribed by spring 819.
[0175] Pressure gauge 800 may also include a whistle 826 with a passage 828 coupled to the open end 803 of housing 802. In some embodiments, a lower surface of whistle 826 can be separated from an upper surface of partition 806. In these embodiments For illustrative embodiments, cover 820 can be configured to move between partition 806 and whistle 826. A filter 808 can be coupled to open end 803 of housing 802 and cover passage 828 of whistle 826. Filter 808 can
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84/110 be a bacteria filter, a dust filter or a moisture filter, for example.
[0176] Figure 12B is a schematic side view illustrating additional details that can be associated with some modalities of pressure indicator 800. For example, housing 802 may also include a window 830 passing through a side wall of housing 802 near the end open 803. In some embodiments, at least a portion of the lid 820 may be visible through the window 830. In some embodiments, the first ring 822 of the lid 820 may be visible through the window 830. In other embodiments, the second ring 824 of the lid 820 it can be visible through the window 830. In still other embodiments, the first ring 822 and the second ring 824 of the lid 820 can be visible through the window 830. In the illustrative embodiment of Figure 12B, the first ring 822 of the lid 820 is visible through the window 830 .
[0177] In operation, the pressure indicator 800 can be fluidly coupled to a reduced pressure therapy system, such as the reduced pressure system 400 or the reduced pressure system 1100. In some embodiments, port 812 can be coupled to a source of reduced pressure and port 810 can be fluidly coupled to a tissue site receiving reduced pressure therapy. For example, port 812 can be fluidly coupled to monitoring port 319, and port 810 can be fluidly coupled to monitoring port 323. During normal operation of the reduced pressure system 400 or the reduced pressure system 1100, the second chamber 815 can be supplied with the supply pressure, and the first chamber 814 can be supplied with the control pressure. THE
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85/110 control pressure in the first chamber 814 and the supply pressure in the second chamber 815 can exert a force on the diaphragm 816. For example, if the supply pressure is greater than the control pressure, the force can push the diaphragm 816 towards the end wall 804. If the supply pressure is less than the control pressure, the force can push the diaphragm 816 towards partition 806. The spring 819 can exert a counter force, also referred to as a spring force , which can be proportional to a spring constant of spring 819 and the distance the spring 819 travels. The combined forces can be referred to as a resultant force acting on the 816 diaphragm.
[0178] If the control pressure and supply pressure are comparable, the pressure differential across diaphragm 816 may be negligible. The spring 819 can be calibrated to be in an equilibrium position in this state, as illustrated in Figure 12A. In some embodiments, diaphragm 816 may be slightly displaced if spring 819 is in the equilibrium position, as also shown in Figure 12A. The cover 820 can have an ambient pressure acting on the cover 820 through the passage 828. The ambient pressure can push the cover 820 to be in contact with the partition 806. In some embodiments, the cover 820 can be fluidly sealed in the partition 806, so that no fluid transfer occurs through opening 807 of partition 806. Placing cover 820 in contact with partition 80 6 can also position the first ring 822 of the cover 820 adjacent to window 830 so that the first ring 822 can be visible through window 830. In some modalities, the
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86/110 first ring 822 is green and can signal that the operating state of the reduced pressure system 400 or the reduced pressure system 1100 is an application of reduced pressure within a therapeutic range.
[0179] Figure 13A is a schematic sectional view illustrating additional details that can be associated with some modalities of pressure indicator 800. Figure 13B is a schematic side view of pressure indicator 800 of Figure 13A. In operation, diaphragm 816 can move towards partition 806 if the supply pressure in the second chamber 815 is less than the control pressure in the first chamber 814. If there is an obstruction in the reduced pressure system 400 or in the reduced pressure system 1100, for example, a difference in the pressure supplied to the second chamber 815 and the first chamber 814 may occur. If there is an obstruction between the reduced pressure source 402 and bandage 404, the reduced pressure provided by the reduced pressure source 402 may not be fluidly communicated to bandage 404. As a consequence, the control pressure in the first chamber 814 can be a reduced pressure lower than the reduced pressure in the second chamber 815.
[0180] In response to the pressure difference in the first chamber 814 and the second chamber 815, diaphragm 816 can move in the direction of partition 80 6. In response, stem 818 coupled to diaphragm 816 can also move in the direction of partition 80 6. Movement of the stem 818 can cause the cap 820 to move away from partition 806, allowing fluid flow through opening 807 of partition 806. In response, ambient air pressure can circulate through filter 808, through passage 828, around the cover 820 and to
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87/110 inside the second chamber 815. The fluid can flow through port 812, which can remove the obstruction. In some embodiments, the flow of ambient air pressure through passage 828 may operate the whistle 826, causing whistle 826 to emit an audible sound. In some embodiments, if the cover 820 moves away from partition 806, the second ring 824 can be positioned adjacent to the window 830, allowing the second ring 824 to be visible through the window 830. In some embodiments, the second ring 824 can be red and can indicate to an operator that the operating state is an obstruction condition or a full vessel condition. Thus, as illustrated in Figure 13A and Figure 13B, pressure indicator 800 can provide a visual signal for an obstruction condition, and can also provide an audible signal.
[0181] The movement of diaphragm 816 towards partition 80 6 can compress spring 819. In response, spring 819 can generate a counter force by pushing diaphragm 816 towards end wall 804. The counter force can be proportional to a spring constant of spring 819 and at a distance at which spring 819 is compressed. If the ambient air pressure circulates into the second chamber 815, the pressure in the second chamber 815 may increase. If the pressure in the second chamber 815 increases sufficiently, the counter force of the spring 819 can overcome the pressure force in the first chamber 814 and in the second chamber 815 to move diaphragm 816 towards the end wall 804. In response, stem 818 and cover 820 can also move towards the end wall 804. Cover 820 can be in contact with partition 806, blocking the opening
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88/110
807 and still preventing the flow of fluid into the second chamber 815 from the environment.
[0182] Figure 14 is a schematic sectional view of a pressure indicator 900 that can be used with some modalities of the reduced pressure system 400 or the reduced pressure system 1100. The pressure indicator 900 is another example of a feedback interface that can provide visual pressure feedback in the illustrative modality of the reduced pressure system 400 or the reduced pressure system 1100. In some embodiments, for example, pressure indicator 900 may be arranged in one or more between location 416 , location 420 or location 424. Pressure gauge 900 may include housing 902, valve 908 and whistle 910. Housing 902 may be cylindrical and have an end wall 903 and a filter 905. The end wall 903 can form a first end of housing 902, and filter 905 can form a second end of housing 902. In some embodiments, filter 905 can be opost o to end wall 903. Housing 902 may have a chamber 906 disposed between end wall 903 and filter 905. Housing 902 may further include a port 904 coupled to end wall 903. In some embodiments, port 904 it can be configured to be fluidly coupled to additional devices or components of a reduced pressure system. Port 904 can provide a fluid pathway into chamber 906. Filter 905 can provide a fluid pathway to the environment, allowing ambient pressure to flow into chamber 906.
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[0183] Valve 908 can be arranged in chamber 906 and has peripheral portions attached to housing 902. In some embodiments, valve 908 can be positioned between port 904 and filter 905. In some embodiments, valve 908 can be separated port 904 and filter 905. In other embodiments, valve 908 can join port 904. Valve 908 can be configured to selectively prevent fluid flow between filter 905 and port 904. In some embodiments, the valve 908 may allow fluid to flow through valve 908 in response to a predetermined pressure differential across valve 908. In some embodiments, the predetermined pressure differential across valve 908 may be referred to as a burst pressure. In some embodiments, valve 908 may be a duck-beak valve configured to break at a predetermined pressure to allow fluid communication through valve 908.
[0184] Whistle 910 can be placed inside chamber 906. In some embodiments, whistle 910 is positioned between valve 908 and filter 905. In some embodiments, whistle 910 joins valve 908. Whistle 910 may have peripheral portions coupled in housing 902. In some embodiments, coupling between whistle 910 and housing 902 may prevent fluid flow through whistle 910. In some embodiments, whistle 910 may include a passage 912 extending through whistle 910. Passage 912 can provide a fluid path through whistle 910. Passage 912 can be configured to emit an audible sound in response to fluid movement through passage 912.
[0185] In operation, port 904 can be
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90/110 fluidly coupled to a component of a reduced pressure system, such as a bandage, a Container or a reduced pressure source, so that the reduced pressure in the reduced pressure system can be fluidly communicated to the 906 chamber through the port 904. Reduced pressure can be present in chamber 906 between valve 908 and port 904. Similarly, ambient pressure can be fluidly communicated to chamber 906 through filter 905. Ambient pressure can be present in chamber 906 between whistle 910 and filter 905. In some embodiments, if the reduced pressure in chamber 906 is equal to or less than a prescribed therapy pressure, valve 908 can remain closed, preventing fluid communication from side to side of valve 908.
[0186] Figure 15 is a schematic sectional view illustrating additional details that may be associated with some modalities of pressure indicator 900. If the reduced pressure in chamber 906 between valve 908 and port 904 exceeds a desired therapy pressure, valve 908 can open as shown in Figure 15. In some embodiments, valve 908 can be calibrated to open only if the reduced pressure in chamber 906 exceeds a desired therapy pressure within an acceptable tolerance. For example, the therapy pressure may be about -120 mm Hg of gauge pressure, but -130 mm Hg may be acceptable. In this way, valve 908 can be calibrated to open if the reduced pressure in chamber 906 between valve 908 and port 904 exceeds -130 mm Hg. In some embodiments, if valve 908 opens, fluid flow can occur through passage 912 of whistle 910. If fluid flows through the passage
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912 from whistle 910, an audible sound can be heard. The audible sound can be interpreted by an operator as a sign of an overpressure condition operating state.
[0187] Figure 16 is a schematic sectional view illustrating details of a pressure indicator 1200 that can be used with some modalities of the reduced pressure system 400 or the reduced pressure system 1100. The pressure indicator 1200 is another example modality a feedback interface that can be used to provide visual pressure feedback in the illustrative modality of the reduced pressure system 400 or the reduced pressure system 1100. In some embodiments, the pressure indicator 1200 can be arranged in any one or more between location 416, location 418, location 424 or location 428.
[0188] In some embodiments, the pressure indicator 1200 may include a housing formed by a side wall 1202 which is generally tubular. In other embodiments, the housing may not be tubular and the side wall 1202 may include more than one wall coupled together to form one side of the pressure indicator 1200. The housing may open adjacent to a first side wall 1202, and a side wall 1206 can be coupled to a second side wall 1202 which is opposite the first end. In some embodiments, the end wall 1206 can be perpendicular to the side wall 1202 and close the pressure indicator housing 1200. The end wall 1206 can have a dome 1208 protruding from the end wall 1206. The dome 1208 can include a
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92/110 window 1210 formed near a summit of the dome 1208.
[0189] In some embodiments, pressure indicator 1200 may also include a base 1212. Base 1212 can be configured to couple side wall 1202 to form a chamber 1203 connected by side wall 1202, end wall 1206 and base 1212. Chamber 1203 can open to the environment through window 1210.
[0190] In some embodiments, the base 1212 can be countersunk to form a connection chamber 1214. For example, a surface of the base 1212 facing away from chamber 1203 may have a countersunk inner portion for the formation of the connection chamber. 1214. Countersinking of the base 1212 can also form a peripheral wall adjacent to the peripheral portions of the base 1212.
[0191] In some embodiments, the base 1212 may include a spring installation. The spring installation can be arranged in connection chamber 1214 near a center of the base 1212. The spring installation can have a side wall 1222 and an end wall 1216. The side wall 1222 can have a tubular shape extending from the end wall 1216 towards chamber 1203. In some embodiments, using an outer surface of base 1212 as a reference, side wall 1222 may have a portion extending towards chamber 1203 and a portion extending away from chamber 1203 In some embodiments, the end wall 1216 can be coupled to one end of the side wall 1222 opposite the chamber 1203 so that the spring installation forms a cavity with an open end near the chamber 1203.
[0192] In some embodiments, a 1220 spring
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93/110 can be arranged in the cavity of the spring installation. The spring 1220 can have a first end positioned adjacent to the end wall 1216, and a second end projecting beyond the side wall 1222. The spring 1220 can have a length Q in a relaxed position as shown in Figure 16 If displaced, the spring 1220 can exert a force proportional to the amount in which the spring 1220 moves from the relaxed position Q.
[0193] The base 1212 may also have an annular wall 1224 extending from the connecting chamber 1214 towards the chamber 1203. In some embodiments, the annular wall 1224 may extend into the chamber 1203 beyond the side wall 1222. In some embodiments, the annular wall 1224 can be positioned radially outwardly from the side wall 1222 of the spring installation. In some embodiments, at least one communication channel 1218 can be formed between the annular wall 1224 and the side wall 1222. In some embodiments, the communication channel 1218 can be fluidly coupled to the connecting chamber 1214.
[0194] A diaphragm 122 6 can be coupled to the end of annular wall 1224. In some embodiments, diaphragm 1226 is arranged in chamber 1203 near the end of side wall 1222 of the spring installation. In some embodiments, diaphragm 122 6 and base 1212 can form a pressure chamber 1225. Pressure chamber 1225 can be arranged between annular wall 1224 and diaphragm 1226. In some embodiments, pressure chamber 1225 can be fluidly isolated from camera 1203 and be in communication
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94/110 fluid with communication channel 1218.
[0195] In some embodiments, the end of spring 1220 may be close to diaphragm 1226. In some embodiments, diaphragm 122 6 may have a spring coupler 1227. In some embodiments, spring coupler 1227 may be arranged close to a center of diaphragm 1226. Spring coupler 1227 can be an annular wall arranged on one side of diaphragm 1226 adjacent to spring 1220. In some embodiments, spring coupler 1227 may have an outer diameter less than an inner diameter of the spring 1220. In some embodiments, the spring coupler 1227 can be inserted into the spring 1220 to operably couple the spring 1220 to the diaphragm 1226.
[0196] In some embodiments, diaphragm 1226 may include a mechanical coupling 1228. Mechanical coupling 1228 may be located near a center of diaphragm 1226. In some embodiments, mechanical coupling 1228 may project from diaphragm 1226 opposite the coupler spring-loaded 1227. Mechanical coupler 1228 can be an annular wall forming a cavity 1229 with a constraint 1231 near an end of the annular wall opposite diaphragm 1226. In some embodiments, diaphragm 1231 can be formed of a silicone material. In some embodiments, diaphragm 1231 may have a hardness rating between about 100 Shore A and about 50 Shore A.
[0197] A retainer 1230 can be attached to base 1212 adjacent to diaphragm 1226. In some embodiments, retainer 1230 can be attached to the ends of annular wall 1224 and to one side of diaphragm 1226 opposite the spring installation. The 1230 retainer may have
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95/110 an opening close to the center of the retainer 1230. In some embodiments, the mechanical coupling 1228 of the diaphragm 1226 may extend through the opening of the retainer 1230. The retainer 1230 may include a fulcrum 1236 disposed outside the opening of the retainer 1230. In some embodiments, fulcrum 1236 may be a pole, column or other body extending into chamber 1203 from a surface of retainer 1230.
[0198] Pressure indicator 1200 can also include lever indicator 1232. Lever indicator 1232 can be a lever arm attached to fulcrum 1236 and extending through chamber 1203 from retainer 1230 to a location close to the end wall 1206. In some embodiments, one end of the lever indicator 1232 may be close to the dome 1208. The lever indicator 1232 may include a pivot 1234 at one end of the lever indicator 1232 coupled to the fulcrum 1236 of retainer 1230. In some embodiments, pivot 1234 can be an axis having a first end coupled to the end of lever indicator 1232 and a second end coupled to fulcrum 1236, so that the end of lever indicator 1232 can be fixed to fulcrum 1236. In some embodiments, the end of lever indicator 1232 coupled to fulcrum 1236 can be referred to as a fixed end, and the opposite end can be referred to as an end loose age. In some embodiments, lever indicator 1232 can rotate around pivot 1234.
[0199] In some embodiments, the lever indicator 1232 may also include an arm 1238 if
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96/110 projecting from one side of lever indicator 1232. In some embodiments, arm 1238 can project towards a center of pressure indicator 1200, so that one end of arm 1238 can be close to mechanical coupling 1228 of the diaphragm 1226. In some embodiments, arm 1238 may have a connection 1240 extending from arm 1238 to connect arm 1238 to mechanical coupling 1228. Connection 1240 may be sized to fit within cavity 1229 and be retained in the coupling mechanical 1228 by constraint 1231. Constraint 1231 can be flexible to allow a body with a diameter greater than constraint 1231 to be inserted by constraint 1231. In some embodiments, connection 1240 may include a detent configured for engaging constraint 1231. A connection 1240 and mechanical coupling 1228 operably couple diaphragm 1226 and lever indicator 1232.
[0200] The loose end of lever indicator 1232 may have a first indication 1242 and a second indication 1244. In some embodiments, at least one between the first indication 1242 and the second indication 1244 may be visible through window 1210.
[0201] In some embodiments, connection chamber 1214 can be coupled to a portion of the reduced pressure system 400 or reduced pressure system 1100. A pressure can be supplied to the pressure chamber 1225 via the communication channel 1218 and the chamber connection 1214. The pressure supplied to the pressure chamber 1225 can act on the diaphragm 1226 together with an ambient pressure on the opposite side of the diaphragm 1226. If the pressure supplied to the pressure chamber 1225 is less than the ambient pressure,
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97/110 differential force moves diaphragm 122 6 towards base 1212. Spring 1220 can have a spring constant, so that the differential force exceeds the spring force of spring 1220 if the pressure in the pressure chamber 1225 is approximately therapy pressure. As shown in the illustrated embodiment of Figure 16, if the reduced pressure in the pressure chamber 1225 is less than the therapy pressure, the differential force may not exceed the spring force of the spring 1220, allowing the spring 1220 to remain in the relaxed position Q , and the first indication 1242 may be visible through window 1210. In some embodiments, the first indication 1242 may be a color, an expression or other visual aid indicating that insufficient reduced pressure is being provided.
[0202] Figure 17 is a schematic sectional view of pressure indicator 1200 in a second position. In the second position of Figure 17, a pressure supplied to the pressure chamber 1225 is approximately the therapy pressure. In response, the differential force can overcome the spring force of spring 1220 by compressing spring 1220 to a compressed position Qi, pushing diaphragm 1226 towards the base 1212. In response, the mechanical coupling 1228 can move towards the base 1212. Link 1240 can also move towards base 1212 in response to movement of mechanical coupling 1228. Movement of link 1240 can pull one end of arm 1238 towards base 1212, which can cause the lever 1232, at least partially, rotate around pivot 1234. Rotating lever indicator 1232 around pivot 1234 can move the second indication 1244 close to window 1210, allowing the second indication 1244 to be
Petition 870160017899, of 05/05/2016, p. 101/269
98/110 visible through window 1210. In some embodiments, the second indication 1244 can be a color, an expression or other visual aid indicating that therapy pressure is being supplied to the pressure chamber 1225.
[0203] Figure 18 is a schematic perspective view illustrating additional details of a pressure indicator 1300 that can be used with some modalities of the reduced pressure system 400 or the reduced pressure system 1100. The pressure indicator 1300 can be another example modality of a feedback interface that can be used to provide visual pressure feedback in the illustrative modality of the reduced pressure system 400 or the reduced pressure system 1100. In some embodiments, the pressure indicator 1300 can be arranged in either or more between location 416, location 418, location 424 or location 428.
[0204] In some embodiments, the pressure indicator 1300 may include a cover 1304 and a base 1302. The cover 1304 may include a side wall 1354 and an end wall 1358. In some embodiments, the end wall 1358 may have a circular shape. The end wall 1358 can include one or more windows 1356. The windows 1356 can be openings through the end wall 1358 that allow visual and / or fluid communication through the end wall 1358. In some embodiments, the windows 1356 can be separated in a manner circumferential around the end wall 1358 near a circumferential edge of the end wall 1358. In some embodiments, the spacing may be equidistant between adjacent windows 1356. In some embodiments, the
Petition 870160017899, of 05/05/2016, p. 102/269
99/110 end 1358 can include a radial stop 1360. The radial stop 1360 can be a projection extending from the end wall 1358. In some embodiments, the radial stop 1360 can be tubular in shape. The side wall 1354 can be a tubular wall and can be coupled to peripheral portions of the end wall 1358. The side wall 1354 can extend from the peripheral portions of the end wall 1358 in the same direction as the radial limiter 1360.
[0205] The base 1302 can be coupled to the cover 1304 and can include a bottom wall 1306 with a disc shape and a side wall 1316 coupled to the bottom wall 1306. In some embodiments, the bottom wall 1306 can be circular in shape. In some embodiments, the bottom wall 1306 can have an opening 1305. The opening 1305 can be formed near a center of the bottom wall 1306.
[0206] In some embodiments, the side wall 1316 may have a tubular shape and a first end coupled to the peripheral portions of the bottom wall 1306. In other embodiments, the side wall 1316 may not be tubular in terms of shape; instead, base 1302 may have more than one contiguous side wall 1316. One end of base 1302 opposite the bottom wall 1306 may be open. In some embodiments, the side wall 1316 can be coupled to the side wall 1354 of the cover 1304 for closing the pressure indicator 1300.
[0207] In some embodiments, pressure indicator 1300 may also include a pedestal 1308. Pedestal 1308 can be attached to the bottom wall 1306 and if
Petition 870160017899, of 05/05/2016, p. 103/269
100/110 extend parallel to the side wall 1316. In some embodiments, pedestal 1308 may include multiple concentric annular walls, for example, an outer annular wall 1310, an intermediate annular wall 1312 and an inner annular wall 1314. The annular wall outer 1310, the intermediate annular wall 1312 and the inner annular wall 1314 can be separated by the respective crowns.
[0208] The inner annular wall 1314 can be arranged close to the opening 1305. In some embodiments, the inner annular wall 1314 can be coaxial with the opening 1305. In other embodiments, the inner annular wall 1314 can circumscribe the opening 1305. In some embodiments embodiments, the inner annular wall 1314 may have an inner diameter greater than an opening diameter 1305. In some embodiments, the inner annular wall 1314 may have a first end coupled to the bottom wall 1306 and a second end extending in parallel in relation to the side wall 1316.
[0209] The intermediate annular wall 1312 can be arranged close to the inner annular wall 1314. In some embodiments, the intermediate annular wall 1312 can be coaxial with respect to opening 1305. The intermediate annular wall 1312 can form a hollow cylinder with an inner diameter greater than an outer diameter of a hollow cylinder formed by the inner annular wall 1314 to form a crown between the inner annular wall 1314 and the intermediate annular wall 1312. In some embodiments, the intermediate annular wall 1312 may be parallel to the wall side 1316 and may have a first end attached to the bottom wall 1306. In some embodiments, the
Petition 870160017899, of 05/05/2016, p. 104/269
101/110 intermediate annular wall 1312 may be longer than the inner annular wall 1314.
[0210] The outer annular wall 1310 can be arranged close to the intermediate annular wall 1312. In some embodiments, the outer annular wall 1310 can be coaxial with respect to opening 1305. The outer annular wall 1310 can form a hollow cylinder with an inner diameter greater than an outer diameter of the hollow cylinder formed by the intermediate annular wall 1312 to form a crown between the intermediate annular wall 1312 and the outer annular wall 1310. In some embodiments, the outer annular wall 1310 may be parallel to the side wall 1316 and has a first end coupled to the bottom wall 1306. In some embodiments, the outer annular wall 1310 may be longer than the inner annular wall 1314 and substantially equal to a length of the intermediate annular wall 1312.
[0211] In some embodiments, a spring 1318 can be arranged on pressure indicator 1300. In some embodiments, spring 1318 may have a first end positioned adjacent to the bottom wall 1306. In some embodiments, the first end spring 1318 can be close to opening 1305. In some embodiments, spring 1318 can be coaxial with respect to opening 1305 and arranged radially inward from the inner annular wall 1314. If spring 1318 is in a relaxed position, the spring 1318 may have a length S between the first end and the second end of spring 1318. In some embodiments, spring 1318 may be longer than the inner annular wall 1314, the annular wall
Petition 870160017899, of 05/05/2016, p. 105/269
102/110 intermediate 1312 and the outer annular wall 1310.
[0212] In some embodiments, a driver assembly 1320 may be arranged on pedestal 1308 opposite the bottom wall 1306. Driver assembly 1320 may include a diaphragm 1321, a wall 1322, a side wall 1324 and a shaft retainer 1326 In some embodiments, diaphragm 1321 may be an annular body with peripheral portions attached to pedestal 1308. In some embodiments, diaphragm 1321 may have an annular wall adapted for engagement in an interference fit within the crown between the outer annular wall 1310 and the intermediate annular wall 1312. In other embodiments, the diaphragm 1321 can be in contact with, and be supported by, the intermediate annular wall 1312 and the outer annular wall 1310. In some embodiments, diaphragm 1321 can form from a silicone material. In some embodiments, diaphragm 1321 can have a hardness rating between about 100 Shore A and about 50 Shore A.
[0213] The side wall 1324 can be an annular wall. In some embodiments, the side wall 1324 can be arranged in an opening in diaphragm 1321 formed by the respective annular shape. In some embodiments, the side wall 1324 may have an inside diameter greater than the outside diameter of the spring 1318 and an outside diameter less than the inside diameter of the inner annular wall 1314. In this way, the side wall 1324 can circumscribe at least a portion of the spring 1318 and have at least a portion circumscribed by the inner annular wall 1314. In some embodiments, the side wall 1324 may have a first end close to the bottom wall 1306 and a second
Petition 870160017899, of 05/05/2016, p. 106/269
103/110 wall opposite the first end.
[0214] Wall 1322 may be an annular member with an opening close to the center of wall 1322. In some embodiments, wall 1322 may have peripheral portions coupled to the second end of side wall 1324. In some embodiments, wall 1322 may be operably coupled to the end of the spring 1318 which is opposite the bottom wall 1306. In some embodiments, the spring 1318 can support the wall 1322 above the bottom wall 1306.
[0215] The shaft retainer 1326 can be a tubular body with a closed end and an open end opposite to the closed end that is coupled to the wall 1322. In some embodiments, the shaft retainer 1326 can be attached to the nearby wall 1322 of the wall opening 1322. In some embodiments, the open end of the shaft retainer 1326 may be coaxial with respect to the opening in the wall 1322. In some embodiments, the shaft retainer 1326 may be inserted into the spring 1318. In some embodiments, the shaft retainer 1326 may include a groove 1328 protruding from an inner surface of a side wall of shaft retainer 1326. In some embodiments, the groove 1328 may extend parallel to the side wall 1316 from wall 1322 to the closed end of the shaft retainer 1326. In some embodiments, the spline 1328 may have a spiral shape. In other embodiments, the 1328 groove may have a helical shape.
[0216] Pressure gauge 1300 may also include a retainer 1330. Retainer 1330 may include an end wall 1332, a side wall
Petition 870160017899, of 05/05/2016, p. 107/269
104/110
1334, an annular wall 1336 and a side wall 1338. The end wall 1332 can be a disk-shaped body with an opening close to the center of the disk-shaped body. The side wall 1334 can be an annular or tubular wall with a first end coupled to the peripheral portions of the end wall 1332. The side wall 1334 can extend from the end wall 1332 towards the bottom wall 1306. The second end of the sidewall 1334 can be coupled to the inner portions of the annular wall 1336. The annular wall 1336 can have an inner diameter that is substantially the same as the outer diameter of the sidewall 1334 and extends radially outward for the formation of upward and outward ridges. down. The side wall 1338 can be coupled to the peripheral portions of the annular wall 1336 and extends towards the bottom wall 1306. In some embodiments, the side wall 1338 may have an inner diameter greater than the diameter of the outer annular wall 1310 of the pedestal 1308. In some embodiments, the projection facing downward from the annular wall 1336 can support and be coupled to diaphragm 1321 adjacent to the intermediate annular wall 1312, thereby securing diaphragm 1321 to pedestal 1308.
[0217] In some embodiments, a rotation indicator 1340 can be attached to retainer 1330. The rotation indicator 1340 can include a disc 1342, a shaft 1344 and a bearing 1348 supporting shaft 1344 on retainer 1330. Axle 1344 can be a cylindrical body with a first end disposed on the shaft retainer 1326 and a second end close to the end wall opening
Petition 870160017899, of 05/05/2016, p. 108/269
105/110
1332. In some embodiments, the shaft 1344 includes a groove 1346. In some embodiments, the groove 1346 may extend over a portion of a length of the shaft 1344. In other embodiments, the groove 134 6 may extend an entire length of the axis 1344. The groove 1346 may be of a suitable size for receiving the groove 1328. In some embodiments, the groove 1346 may be a spiral or groove cut groove. Generally, the slot 1346 can be of a size and shape suitable for receiving a size and joining shape of the 1328 groove.
[0218] In some embodiments, bearing 1348 may be coupled to the second end of shaft 1344 near the opening in wall 1322. In some embodiments, bearing 1348 may be a cylindrical body with an outer diameter greater than an outer diameter of shaft 1344 The bearing 1348 may have a groove 1341 formed in a side wall portion of the bearing 1348. The groove 1341 may be of a size suitable for receiving a portion of the adjacent wall 1322 in relation to the opening of the wall 1322. In some embodiments, the 1341 groove of bearing 1348 can function as a plain bearing. In other embodiments, the groove 1341 can be a roller bearing or a fluid bearing, for example.
[0219] In some embodiments, the disc 1342 may be coupled to the bearing 1348 opposite the 1344 shaft. In some embodiments, the disc 1342 may be a disc-shaped body. In other embodiments, the disc 1342 may include a circular end wall, a tubular side wall coupled to the peripheral portions of the end wall, and an annular wall coupled to the side wall
Petition 870160017899, of 05/05/2016, p. 109/269
106/110 tubular and extending radially outward. For example, disk 1342 may be adapted to receive radial limiter 1360 near a center of disk 1342. In other embodiments, radial limiter 1360 may not be included. In some embodiments, the disc 1342 may have a surface close to the end wall 1358 of the cover 1304. In some embodiments, the disc 1342 may have one or more indicators 1352 coupled to the surface of the disc near the end wall 1358. The indicators 1352 they can be spaced circumferentially around disk 1342 near a circumferential edge of disk 1342. In some embodiments, indicators 1352 can be spaced equidistantly around the circumference of disk 1342. In some embodiments, indicators 1352 can be aligned with windows 1356 so that, if a 1352 indicator is aligned with a 1356 window, each of the 1352 indicators can be aligned with a respective 1356 window.
[0220] Figure 19 is a schematic perspective view illustrating additional details of a pressure indicator 1300 that can be used with some modalities of the reduced pressure system 400 or the reduced pressure system 1100. In some modalities, a reduced pressure on pressure indicator 1300 through opening 1305 on the bottom wall 1306. The reduced pressure provided to pressure indicator 1300 through opening 1305 can exert a force on diaphragm 1321 by pushing diaphragm 1321 towards the bottom wall 1306. Similarly, the ambient pressure provided by the 1356 windows can exert a force on the 1321 diaphragm. The combined forces can be
Petition 870160017899, of 05/05/2016, p. 110/269
107/110 considered a differential force acting on diaphragm 1321. The differential force can push diaphragm 1321 towards the bottom wall 1306 if the pressure provided by opening 1305 is less than the ambient pressure. As illustrated in Figure 19, the differential force is less than the force of spring 1318, and diaphragm 1321 may not move in response.
[0221] Figure 20 is a schematic perspective view illustrating additional details of a pressure indicator 1300 that can be used with some modalities of the reduced pressure system 400 or the reduced pressure system 1100. If the reduced pressure provided by opening 1305 is approximately the therapy pressure, the differential force can overcome the force of spring 1318 by pushing diaphragm 1321 towards the bottom wall 1306. In response, the rest of driver assembly 1320 coupled to diaphragm 1321 can also be pushed in the direction of the bottom wall 1306, so that the shaft retainer 1326 and the wall 1322 move towards the bottom wall 130 6, compressing the spring 1318 from the relaxed position. The retainer 1330 can prevent the rotation indicator 1340 from moving towards the bottom wall 1306 by bearing 1348 and the end wall 1332. Since the shaft retainer 1326 moves towards the bottom wall 1306 and the shaft 1344 no, the spline 1328 can be moved through the groove 1346, causing the 1344 axis to rotate. In response, the disc 1342 can rotate and align the 1352 indicators with the 1356 windows, providing an indication that the pressure supplied is approximately the pressure of therapy. If the reduced pressure supply through opening 1305 is removed, the differential force can move to zero, and spring 1318 can
Petition 870160017899, of 05/05/2016, p. 111/269
108/110 exert a force proportional to the distance at which the spring 1318 is compressed from the relaxed position S to a compressed position Si, which causes the axis 1344 to rotate again to the position illustrated in Figure 19.
[0222] The feedback interfaces on the reduced pressure system 400 or reduced pressure system 1100 can be configured to address specific concerns. For example, if an operator is concerned about the operating states of the overpressure condition, the operator can use pressure indicator 600, pressure indicator 700 or pressure indicator 900 at location 416, at location 420, at location 424 and location 428. If an operator is concerned about the operating states of the leak condition, the operator can use pressure indicator 600, pressure indicator 700 or pressure indicator 900 at location 416, at location 420, at location 424 and location 428. If an operator is concerned about the operating states of the obstruction condition or full vessel condition, the operator can use pressure indicator 800 at location 426. If an operator is concerned with a state application pressure therapy operation, the operator can use pressure indicator 500 at location 416, at location 418, at location 420, at location 424, at location 426, at location location 428 or location 430. Each feedback interface operates independently of the others and can be selected by an operator based, at least in part, on a cost, a desired feedback and an operating zone.
[0223] In some modalities, regulator 200
Petition 870160017899, of 05/05/2016, p. 112/269
109/110 can include monitoring ports similar to monitoring port 319 and monitoring port 323 of regulator 300. Similarly, regulator 300 may include T-pieces similar to T-215 and T-217 of regulator 200. The monitoring ports and T-pieces can be similarly coupled to the respective regulators and work in a similar way.
[0224] In some embodiments, a secondary regulator can be positioned in line between a reduced pressure source and regulator 300 for removing obstructions. A secondary regulator may include a release mechanism allowing the secondary regulator to fill the loading chamber 308 with a higher pressure in an attempt to eliminate obstructions. It is possible to provide feedback to an operator that an obstruction has been eliminated as described above. In addition, the system may have a discharge valve to ensure that, after an obstruction is removed, the pressure in a tissue location cannot increase above a predetermined safety limit.
[0225] The devices and systems described here can provide definitions of variable negative pressure to an operator, feedback to an operator about leakage conditions, feedback to an operator about obstruction conditions, feedback to an operator about full vessel conditions, can low cost, can be disposable, can be used for a single patient or reusable, and can be highly configurable.
[0226] It should be clear from the foregoing that systems, methods and
Petition 870160017899, of 05/05/2016, p. 113/269
110/110 devices with significant advantages. For example, a variety of feedback methods and interfaces have been described to provide feedback on the state of a reduced pressure system, as well as actions that may be required to continue therapy without significant interruption. Some example modalities can provide feedback that the reduced pressure is being applied to a tissue site, and some example modalities can also integrate an overpressure valve with a pressure indicator. Additionally or alternatively, some modalities may provide feedback for leakage conditions, obstruction conditions and full vessel conditions. The illustrative modalities described here also exemplify how this feedback can be implemented in a low-cost system powered by wall suction without the need for an internal or external power supply.
[0227] Although illustrated in only a few ways, the systems, methods and apparatus illustrated are susceptible to various changes, modifications and uses covered in the claims that follow.

权利要求:
Claims (15)
[1]
1. REDUCED PRESSURE SYSTEM, characterized by comprising:
a bandage;
a regulator comprising:
a supply chamber adapted to be fluidly coupled to the bandage, a control chamber adapted to be fluidly coupled to the bandage, a loading chamber fluidly coupled to the supply chamber via a port, and a regulator valve coupled in the control chamber and operable to reciprocate, at least partially, within the control chamber for the control of fluid communication through the door based on a differential between a control pressure in the control chamber and a therapy pressure; and a feedback interface fluidly coupled to the regulator and adapted to signal an operating state of the reduced pressure system in response to a pressure received by the fluid coupling.
[2]
2. SYSTEM, according to claim 1, characterized in that the feedback interface is fluidly coupled between a container and the regulator, between the control chamber and the supply chamber, or between the bandage and one of a container, the control chamber, the supply chamber and the regulator.
[3]
3. SYSTEM, according to claim 1, characterized in that the feedback interface is fluidly coupled between a source of reduced pressure and
Petition 870170073357, of September 28, 2017, p. 5/13
2/6 the regulator, or between the reduced pressure source and the loading chamber.
[4]
A system according to any one of claims 1 to 2, characterized in that the feedback interface comprises a side wall configured to yield if the reduced pressure exceeds the therapy pressure.
[5]
5. SYSTEM according to any one of claims 1 to 3, characterized in that the feedback interface comprises:
a whistle;
a mechanical pressure gauge;
a visual feedback interface; or a visual feedback interface and an overpressure valve.
[6]
6. SYSTEM, according to claim 1, characterized in that the visual feedback is fluidly coupled between the control chamber and the supply chamber, and;
the feedback interface comprises:
a window, a first indicator ring and a second indicator ring;
the first indicator ring will be configured to be visible through the window at a first pressure; and the second indicator ring will be configured to be visible through the window at a second pressure.
[7]
7. SYSTEM according to any one of claims 1 to 3, characterized in that the feedback interface comprises:
a housing comprising a chamber arranged
Petition 870170073357, of September 28, 2017, p. 6/13
3/6 between an end wall and an open end, and a window near the open end;
a diaphragm disposed in the chamber, the diaphragm having a peripheral portion coupled to the housing;
a rod coupled to the diaphragm and having a portion passing through the diaphragm;
a cap attached to one end of the rod near the open end of the housing, the cap having a plurality of indicator rings; and a tilt member coupled between the diaphragm and the end wall, wherein the tilt member is adapted to exert a force by pushing the diaphragm towards the open end.
[8]
8. SYSTEM, according to claim 7, characterized in that the stem has a cavity and the feedback interface further comprises:
a valve member disposed in the cavity;
a spring arranged in the cavity between the valve member and an end of the spring; and a whistle attached to the lid.
[9]
9. SYSTEM, according to claim 1, characterized in that it comprises at least two feedback interfaces, in which a first feedback interface is fluidly coupled between the supply chamber and the control chamber and a second interface feedback loop is fluidly coupled between the first feedback interface and the loading chamber or the control chamber.
[10]
10. SYSTEM, according to claim 1, characterized by the feedback interface comprising:
Petition 870170073357, of September 28, 2017, p. 7/13
4/6 a housing having an end wall and an open end opposite the end wall;
a diaphragm disposed within the housing and forming a first chamber and a second chamber, the first chamber adapted to be fluidly coupled in the control chamber and the second chamber adapted to be fluidly coupled in the supply chamber;
a partition arranged in the housing between the diaphragm and the open end, the partition having an opening;
a rod extending through the partition opening, the rod having a first end coupled to the diaphragm;
a spring coupled between the diaphragm and the partition, the spring circumscribing the stem and adapted to push the diaphragm towards the end wall;
a cap attached to the stem opposite the diaphragm, the cap having a first portion with a first color and a second portion with a second color; and a whistle attached to the open end of the enclosure and adapted for the emission of an audible sound;
wherein an increase in reduced pressure in the second chamber relative to the first chamber pushes the diaphragm towards the partition, exposing the second color through a window and allowing fluid communication by the whistle with the second chamber.
[11]
11. SYSTEM according to any one of claims 1 to 3, characterized in that the feedback interface comprises:
a housing having a chamber disposed between an end wall and an open end;
Petition 870170073357, of September 28, 2017, p. 8/13
5/6 a valve positioned inside the chamber and adapted to open in response to differential pressure across the valve; and a whistle positioned adjacent to the valve and adapted to emit an audible sound in response to the valve opening.
[12]
12. SYSTEM, according to any one of claims 1 to 3, characterized in that the feedback interface comprises:
a housing having a window at a first end;
a diaphragm disposed in the housing for forming a pressure chamber at a second end of the housing;
a lever having a fixed end attached to the housing and a loose end close to the window;
an arm having a first end coupled to the lever and a second end coupled to the diaphragm, the arm being configured for rotation of the lever in response to movement of the diaphragm;
an indicator attached to the loose end of the lever; and a tilt member coupled between the diaphragm and a second end of the housing, wherein the tilt member is adapted to exert a force by pushing the diaphragm towards the first end.
[13]
13. SYSTEM according to any one of claims 1 to 3, characterized in that the feedback interface comprises:
a casing having at least one window in one
Petition 870170073357, of September 28, 2017, p. 9/13
6/6 first end;
a diaphragm disposed in the housing for forming a pressure chamber at a second end of the housing;
a disc having at least one indicator, the disc operably coupled to the diaphragm and configured for rotation in response to movement of the diaphragm; and a tilt member coupled between the diaphragm and a second end of the housing, wherein the tilt member is adapted to exert a force by pushing the diaphragm towards the first end.
[14]
14. A system according to any one of claims 1 to 13, characterized in that it further comprises a wall suction source fluidly coupled to the loading chamber.
[15]
A system according to any one of claims 1 to 14, characterized in that the operating state comprises at least one application between a reduced pressure, a leakage condition, an obstruction condition, a full vessel condition and a condition overpressure.

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同族专利:

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EP3639865A3|2020-07-22|

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US20150094674A1|2015-04-02|

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EP3052158B1|2017-11-22|

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EP3281651A3|2018-06-13|

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CN105682698B|2019-06-07|

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WO2015051018A2|2015-04-09|

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US10105472B2|2018-10-23|

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CN105682698A|2016-06-15|

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EP3639865A2|2020-04-22|

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WO2015051018A3|2015-07-09|

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EP3281651B1|2019-12-11|

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法律状态:
2020-08-04| 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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US201361885781P| true| 2013-10-02|2013-10-02|

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PCT/US2014/058667|WO2015051018A2|2013-10-02|2014-10-01|Disposable reduced-pressure therapy system with mechanical feedback|

---