Negative pressure wound therapy pump apparatus and method

Abstract

A pump assembly (200) for delivering negative pressure to a wound dressing includes a housing (202), a pump (1002) and a manifold (1000) fluidly linked to the pump. The manifold (1000) establishes a fluid connection between the pump (1002) and a connector (210) formed in the housing (202).

Description

NEGATIVE PRESSURE WOUND THERAPY PUMP APPARATUS AND METHOD FIELD

[0001] The present disclosure is directed towards a negative pressure wound therapy assembly, and more specifically to a pump assembly and method for controlling and manufacturing the same.BACKGROUND

[0002] Negative pressure wound dressing assemblies are known and are generally suitable for treating a variety of wounds, including chronic and acute wound types, such as infected wounds, venous ulcers, diabetic ulcers, burns and surgical wounds.

[0003] Negative pressure has been used to treat a range of chronic and acute wounds. Negative pressure may facilitate wound healing through a number of mechanisms, including removal of excess exudate, reduction in periwound edema and increased perfusion. Combined with the physical forces exerted by the negative pressure which draw the wound edges together, this can result in improved wound outcomes. Conventional devices are generally large and require the use of sophisticated equipment which may include a suction pump to generate negative pressure, a pressure regulator, canisters for the collection of wound exudate and a wound dressing to deliver the therapy to the wound site. As a result, such devices may be bulky, costly and confine the patient to bed or at least render the patient immobile and unable to go about their usual activities.

[0004] More recently, portable (or “canisterless”) systems have been developed which include a means to manage the exudate produced by the wound by collecting exudate within the wound dressing, typically in an absorbent material, and by evaporation through the dressing. Such systems mean that a separate collection canister may not be an essential part of the system. Such a system is described in EP 2021046. An advantage of not needing a canister is that the device is less bulky and more portable. A disadvantage with such devices is that if the dressing exceeds its fluid handling capacity, exudate may be drawn from the absorbent material(s) and enter the pump.

[0005] The presence of exudate in the pump will eventually cause it to fail and require its replacement. The therapy provided by the system may also be less than optimal due to the potential for excess exudate to collect at the wound interface. In order to prevent fouling of the pump with exudate, it is known to provide a barrier layer between the absorbent material and the pump. The liquid barrier layer does not however give the user of the device or care giver an indication that the dressing has exceeded its fluid handling capacity and needs to be changed.1 170534979vl

[0006] In those devices where a canister is present, the user or care giver is given a visual indication of how much exudate is being produced by the wound by the presence of exudate in the canister.

[0007] Additionally, existing portable negative-pressure wound dressing systems often include inefficient power management systems that do not promote efficient use of the pump assembly. Further, existing pump assemblies do not adequately monitor and manage leaks detected in the system, among other things. Thus, there exists a need for a portable exudate management system that incorporates these, and other, features. The present disclosure seeks to overcome limitations and other drawbacks of the prior art, and to provide new features not heretofore available. A full discussion of the features and advantages of the present disclosure is deferred to the following detailed description, which proceeds with reference to the accompanying drawings.SUMMARY

[0008] According to a first broad aspect of the present invention, there is provided a pump assembly. The pump assembly may be for providing a negative pressure to a wound dressing. The pump assembly may include a housing. The pump assembly may include a pump (also herein referred to throughout in the alternative as “a diaphram pump”) coupled to the housing. The pump may be powered by a motor. The pump assembly may include a microprocessor. The microprocessor may be configured to selectively power the motor. The pump assembly may include a manifold. The manifold may be fluidly coupled to the pump. The manifold may fluidly couple the pump with a connector. The connector may be formed in the housing.

[0009] According to a first aspect of the present invention, there is provided a pump assembly for providing a negative pressure to a wound dressing, comprising: a housing; a pump (e.g., a motor-driven diaphragm pump); and a manifold fluidly coupled to the pump and fluidly coupling the pump with a connector formed in the housing.

[0010] In the invention, the housing and connector (which in practice fluidly connects the pump assembly to the negative pressure wound dressing) are formed together integrally. This provides improved leak protection as fluid cannot get between gaps between the connector and housing like in prior arrangements. Advantageously, the integral construction of the connector with the housing provides a particularly robust construction where, for example, the assembly is more likely to be able to function, if it is accidentally dropped by a user.

[0011] The pump may be coupled to the housing. The pump may be powered by a motor.2 170534979vl

[0012] The pump assembly may further comprise a microprocessor. The microprocessor may be configured to selectively power the motor.

[0013] The connector may be formed in material of the housing. The material may be cast material. The material may be molded material. The housing and connector may be integrally formed. The housing and connector may be formed as one piece. The housing and connector may be molded as one piece. The housing and connector may be cast as one piece. The housing and connector may be seamlessly connected. The housing and connector may be formed simultaneously. The material of the housing may comprise plastic.

[0014] The connector may be a fluid connector.

[0015] The connector may be configured to fluidly couple the pump to a tube set.

[0016] The manifold may include a check valve and / or a pressure sensor. The manifold may contain a pressure relief valve. The manifold may contain a pressure relief valve interface configured to be fluidly couple to a pressure relief valve. The manifold may feature a housing interface. The housing interface may be configured to space the manifold from a housing surface. The housing interface may be configured to space the manifold from a housing surface, aligning it with the connector and pump. The manifold may incorporate a pressure sensor interface. The pressure sensor interface may be configured to be fluidly coupled to a pressure sensor. The manifold may incorporate a check valve interface. The check valve interface may be configured to house a check valve. The manifold may include a vacuum pump interface. The vacuum pump interface may be configured to be fluidly coupled to the pump. The manifold may have a projection that corresponds with a cutout in the housing, aligning the manifold with the housing. The manifold may further include a check valve. The manifold may further include a pressure relief valve. The manifold may further include a pressure sensor. The manifold may further include a check valve, a pressure relief valve, and a pressure sensor.

[0017] The assembly may comprise an indicator. The indicator may be positioned within a sealed interior of the housing. The indicator may be configured to be selectively illuminated. The indicator may illuminate an indicator section visible from the surrounding environment. The indicator may provide a confirming indication when the pump assembly is functioning properly. The indicator may provide a battery status indication identifying a status of the battery. The pump may be a diaphragm pump. The pressure sensor may be a pressure transducer. The pressure transducer may be configured to provide feedback to the microprocessor to selectively power the3 170534979vlmotor and pump. The pressure transducer may be configured to provide feedback to the microprocessor to selectively power the motor and pump to a specific pressure. The pressure relief valve may be a mechanical pressure relief valve fluidly coupled to the pump. The pressure relief valve may be configured to selectively prevent extreme pressures from being generated by the pump.

[0018] The housing may comprise a housing body. The housing may comprise the housing body and the connector. The connector may extend from the housing body. The connector and housing body may be integrally formed. The connector may include an exterior projecting part that projects from an exterior of the housing body. The connector may include an interior projecting part which projects from the housing body within the housing. The interior projecting part may comprise a first couplable end. The first couplable end may be configured to be coupled to the manifold. The exterior projecting part may comprise a second couplable end. A diameter of the first couplable end may be greater than the second couplable end. A length of the interior projecting part may be greater than the exterior projecting part. An inner diameter of the internal projecting part may be greater than or substantially equal to an outer diameter of the exterior projecting part. Each of or both of the interior projecting part and exterior projecting part may be substantially cylindrical. The interior projecting part and exterior projecting part may share a common axis.

[0019] The exterior projecting part may comprise a circumferential rib. The circumferential rib may be spaced from where the exterior projecting part projects from the housing body. The circumferential rib may be spaced from the second couplable end. The circumferential rib may be provided on an exterior of the exterior projecting part. The circumferential rib may taper inwardly to a free end thereof. The circumferential rib may taper inwardly in a radial direction. The circumferential rib may taper inwardly to a point.

[0020] The interior projecting part may comprise a main portion. The interior projecting part may comprise a converging portion. The interior projecting part may comprise an end face. The main portion may extend from the housing body to the converging portion. The converging portion may extend from the housing body to the end face.

[0021] The second couplable end may be configured to be coupled to medical tubing connected to the wound dressing. A push fit connection may connect the manifold and connector. The manifold may be fitted over the interior projecting part of the connector. The manifold may have a pump opening coupled to the pump. The manifold may comprise a pump opening coupled to the4 170534979vlpump. The manifold may comprise a housing opening coupled to the connector of the housing. The connector may be located between the pump opening and the housing opening. The pump opening may have a pump opening axis. The housing opening may have a housing opening axis. The pump opening axis may be co-directional with the housing opening axis. The pump opening axis and housing opening axis may be the same. The pump opening axis and housing opening axis may be co-axial with the common axis shared by the interior projecting part and exterior projecting part. The manifold body may be formed from a manifold material. The manifold material may be resiliently flexible material. The manifold material may be an elastomeric material. The elastomeric material may be a synthetic or natural rubber. The material may comprise plastic. The plastic may be thermoplastic. Preferably, the material comprises a Thermoplastic Elastomer (TPE). The housing opening may be resiliently deformable. The housing opening may be deformed with respect to its rest state when the manifold forms the push fit connection with the connector.

[0022] Foam may be provided within the housing. The foam may be provided on the pump. The foam may be provided on the motor. The foam may be provided on a suction element (e.g., diaphragm) of the pump. The foam may be provided in one or more parts. The foam may be silicone foam. The foam may be low density silicone foam. The foam may be BISCO BF-1000. The foam may have a density in the range of 8 to 14 PCF. The foam may have a density of 12 PCF. The foam may be closed cell or open cell. The foam may be acoustic foam.

[0023] The pump may be battery powered. The pump may be powered by one or more batteries. The one or more batteries may comprise one or more replaceable batteries. The one or more batteries may comprise one or more rechargeable batteries. The one or more batteries may comprise one or more alkaline or lithium batteries. The one or more batteries may comprise one or more AA batteries, which are preferably rechargeable. The one or more batteries may power the motor of the pump. The housing may comprise a battery cover coupled to the housing body. The batteries may be located beneath the battery cover. The batteries may be located within the sealed interior.

[0024] The assembly may comprise a printed circuited board assembly (PCBA). The microprocessor may be coupled to the printed circuit board assembly. The printed circuit board assembly may have four layers.

[0025] The housing may comprise the housing body and a top cover. The top cover may be removably coupled to the housing body.5 170534979vl

[0026] The assembly may comprise one or more electrical lights. The PCBA may comprise the one or more electrical lights. The one or more electrical lights may be configured to emit light. The one or more electrical lights may be configured to emit light when an instruction from the microprocessor is received. The one or more electrical lights may be located inside the housing. The one or more electrical lights may be located inside the housing. The housing may be translucent so the one or more electrical lights can be seen from an exterior of the housing when they emit light.

[0027] A portion of the housing covering the one or more electrical lights may be thinned. The portion of the housing covering the one or more electrical lights may be thinned relative to the rest of the housing. The top cover may comprise the portion of the housing covering the one or more electrical lights. The portion may be thinned relative to the rest of the top cover. The portion may be a translucent portion. The housing may further comprise a non-translucent portion. The translucent portion may be thinner than the non-translucent portion. The top cover may comprise the non-translucent portion and the translucent portion.

[0028] One or more markings may be provided on an external portion of the housing. One or more markings may be provided on an external portion of the housing in the region covering the one or more electrical lights. Preferably, there are three electrical lights and three marks on the external portion of the housing in the region covering the three electrical lights. A first of the three marks may be a check mark. A second of the three marks may be an exclamation mark. A third of the three marks may be a battery symbol. The one or more electrical lights may be one or more light emitting diodes (LED)s. The top cover may be the portion of the housing covering the one or more electrical lights. The top cover may comprise the one or more markings.

[0029] According to a second broad aspect of the present invention, there is provided a pump assembly. The pump assembly may be for providing negative pressure to a wound dressing. The pump assembly may include a housing. The housing may comprise a top cover. The top cover may be removably coupled to a housing body. The housing body and / or top cover may define a sealed interior. The pump assembly may comprise a pump. The pump may be a motor-driven diaphragm pump. The pump may be coupled to the housing body. The pump may be powered by a motor. The assembly may further comprise microprocessor. The microprocessor may be configured to selectively power the motor. The pump assembly may comprise an operational button, The operational button may be integrated into a top cover of the housing.. The operational button may6 170534979vlbe integrated into a top cover of the housing such that the interface provides a fluid-tight transition from the surrounding environment to the sealed interior around the operational button.

[0030] According to a second aspect of the present invention, there is provided a pump assembly for providing a negative pressure to a wound dressing, comprising: a housing comprising a top cover removably coupled to a housing body, the housing defining a sealed interior; a pump and an operational button integrated into a top cover of the housing such that the interface between the operational button and the top cover provides a fluid-tight transition from the surrounding environment to the sealed interior around the operational button.

[0031] The pump may be coupled to the housing body. The pump may be powered by a motor. The pump may be a motor-driven diaphragm pump. The assembly may comprise a microprocessor. The microprocessor may be configured to selectively power the motor.

[0032] The operational button may be overmolded to the top cover. The pump assembly may further include a belt clip. The belt clip may be configured to be removably coupled to the housing. The assembly may further comprise a tube set. The tube set may be configured to fluidly couple a wound dressing to the pump. The operational button may be formed through an overmolding process with the top cover. The top cover may have a cover gasket. The cover gasket may be formed through an overmolding process. The cover gasket may be formed through an overmolding process with the top cover. The cover gasket may form a loop that extends parallel to a perimeter of the top cover. The cover gasket and operational button may be formed in the same overmolding process.

[0033] The operational button and cover gasket may be integrally formed. The operational button and cover gasket may be formed as one piece. The operational button and cover gasket may be overmolded as one piece. The operational button and cover gasket may be seamlessly connected. The operational button and cover gasket may be formed simultaneously.

[0034] The housing body may have a body gasket. The body gasket may be formed through an overmolding process. The body gasket may be formed through an overmolding process with the housing body. The body gasket may be configured to be aligned with the gasket of the top cover. The housing body may define a battery compartment. The battery compartment may have a battery gasket. The battery gasket may be formed through an overmolding process with the housing body. The battery gasket may be formed through an overmolding process with the housing body around the battery compartment.7 170534979vl

[0035] The assembly may comprise an elastomeric material. The operational button may be formed from the elastomeric material. The cover gasket may be formed from the elastomeric material. The body gasket may be formed from the elastomeric material. The battery gasket may be formed from the elastomeric material. The elastomeric material may be a synthetic rubber. The elastomeric material may be thermoplastic vulcanizate. The elastomeric material may be Santoprene.

[0036] The assembly may further comprise a manifold fluidly coupled to the pump within the housing.

[0037] The microprocessor and / or motor may be positioned within the sealed interior. The housing may be formed of PC / ABS. The housing may further comprise a battery cover. The housing may comprise the top cover, the housing body, and the battery cover. The top cover, housing body and battery cover may be coupled to one another to define the sealed interior. The manifold may be formed from Santoprene.

[0038] The assembly may comprise a printed circuited board assembly. The microprocessor may be coupled to the printed circuit board assembly. The printed circuit board assembly may have four layers.

[0039] The printed circuit board assembly may be configured to mitigate electromagnetic interference. Foam wrapping may surround at least a portion of the pump. The foam wrapping may reduce noise and / or vibration. Additional foam wrapping may surround at least a portion of the motor. The additional foam wrapping may reduce noise and / or vibration. The tube set may be coupleable to a wound dressing through a Swabbable Luer. The Swabbable Luer may fluidly isolate the wound dressing from the surrounding environment when the tube set is disconnected.

[0040] The housing may comprise a fluid connector. The manifold may be fluidly connected to the fluid connector. The housing may comprise the housing body and the fluid connector. The fluid connector and housing body may be integrally formed. The fluid connector may extend from the housing. The manifold may be fitted in or over the fluid connector. The fluid connector may be connectable to tubing fluidly coupled to the negative pressure wound dressing. The housing body and connector may be formed as one piece. The fluid connector may comprise a Luer fitting. The Luer fitting may comprise a female Luer fitting. The fluid connector may comprise the Swabblable Luer.8 170534979vl

[0041] Foam may be provided within the housing. The foam may be provided on the pump. The foam may be provided on the motor. The foam may be provided on a suction element of the pump. The foam may be provided in one or more parts. The foam may be silicone foam. The foam may be low density silicone foam. The foam may be BISCO BF-1000. The foam may have a density in the range of 8 to 14 PCF. The foam may have a density of 12 PCF . The foam may be closed cell or open cell. The foam may be acoustic foam. The foam may be the foam wrapping.

[0042] The pump may be battery powered. The pump may be powered by one or more batteries. The one or more batteries may comprise one or more replaceable batteries. The one or more batteries may comprise one or more rechargeable batteries. The one or more batteries may comprise one or more alkaline or lithium batteries. The one or more batteries may comprise one or more AA batteries, which are preferably rechargeable. The one or more batteries may power the motor. The batteries may be located beneath the battery cover. The batteries may be located within the sealed interior.

[0043] The manifold may have a pump opening coupled to the pump. The manifold may comprise a housing opening coupled to the fluid connector of the housing. The housing connector may be the fluid connector. The connector may be located between the pump opening and the housing opening. The pump opening may have a pump opening axis. The housing opening may have a housing opening axis. The pump opening axis may be co-directional with the housing opening axis. The pump opening axis and the housing opening axis may be the same.

[0044] The assembly may comprise one or more electrical lights. The PCBA may comprise the one or more electrical lights. The one or more electrical lights may be configured to emit light. The one or more electrical lights may be configured to emit light when an instruction from the microprocessor is received. The one or more electrical lights may be located inside the housing. The one or more electrical lights may be located inside the housing. The housing may be translucent so the one or more electrical lights can be seen from an exterior of the housing when they emit light.

[0045] A portion of the housing aligned with covering the one or more electrical lights may be thinned. The portion of the housing covering the one or more electrical lights may be thinned relative to the rest of the housing. The top cover may comprise the portion of the housing covering the one or more electrical lights. The portion may be thinned relative to the rest of the top cover. The portion may be a translucent portion. The housing may further comprise a non-translucent9 170534979vlportion. The translucent portion may be thinner than the non-translucent portion. The top cover may comprise the non-translucent portion and the translucent portion.

[0046] One or more markings may be provided on an external portion of the housing. One or more markings may be provided on an external portion of the housing in the region covering the one or more electrical lights. Preferably, there are three electrical lights and three marks on the external portion of the housing in the region covering the three electrical lights. A first of the three marks may be a check mark. A second of the three marks may be an exclamation mark. A third of the three marks may be a battery symbol. The one or more electrical lights may be one or more light emitting diodes (LED)s.

[0047] The housing may be curved. The top cover may be curved. The top cover may be an arced sheet. The top cover may comprise a curve. The curve may extend across the top cover between opposing edges of the top sheet. The top cover may comprise a plurality of ribs. The plurality of ribs may be located on an inner surface of the top cover.

[0048] The curve in the top cover means the pump assembly conforms better to a user’s form, meaning that it can be more easily worn about the user’s person. This improves the useability of the assembly.

[0049] The plurality of ribs may be located within the sealed interior when the top cover is removably coupled to the housing body of the housing. The plurality of ribs may comprise sets of ribs. The ribs of the sets of ribs may be spaced apart. The sets of ribs may intersect each other. The inner surface of the top cover may comprise one or more fastener receiving portions. The fastener receiving portions may be for receiving one or more elongate fasteners. The one or more elongate fasteners may attach the top cover to the housing. The one or more elongate fasteners may be metal. The fastener receiving portions may be substantially cylindrical. Preferably, one of the ribs of the plurality of ribs comprises the one or more fastener receiving portions.

[0050] Preferably, there are at least two fastener receiving portions, and preferably each of the fastener receiving portions is for receiving an elongate fastener. Most preferably, the one of the ribs comprises two fastener receiving portions and there are two elongate fasteners.

[0051] The plurality of ribs may include longitudinally extending ribs and laterally extending ribs. The sets of ribs may intersect each other to form crosses. The longitudinally extending ribs and laterally extending ribs may intersect each other to form the crosses.10 170534979vl

[0052] The operational button may comprise an operational button inner surface. The plurality of ribs may comprise a first rib with a first part circular portion. The first part circular portion may partially surround the operational button inner surface of the operational button. The operational button may comprise an interior projection which projects within the sealed interior. The interior projection may comprise a flange which underlies the first part circular portion. Optionally, the interior projection is a first interior projection and there is a second interior projection having the same form as the first interior projection.

[0053] The ribs provide strength to the top cover, ensuring that it is less likely to break when subjected to a significant load (for example, if the assembly is dropped or knocked). The ribs are particularly useful for providing strength to the cover when it is curved. The ribs provide resistance to deformation of the cover when fasteners received therein are tightened to attach the top cover to the housing body.

[0054] The microprocessor may be operable to selectively turn the pump on when the button is pressed. The operational button inner surface of the operational button may be in contact with the PCBA. The operational button inner surface of the operational button may be in contact with the PCBA such that when an exterior portion of the button is pressed by the user the microprocessor turns the pump off or on.

[0055] According to a third broad aspect of the present invention, there is provided a method. The method may be for controlling the pressure provided to a dressing in a negative pressure wound therapy system. The method may involve monitoring an applied pressure. The method may involve establishing a desired pressure range through an establishment phase. The establishing a desired pressure range through an establishment phase may be implemented with a microcontroller. The microcontroller may selectively power a pump assembly to provide negative pressure. The microcontroller may execute a pressure maintenance phase when the applied pressure is within the desired pressure range. The microcontroller may provide an indication if the pressure maintenance phase is outside of maintenance parameters.

[0056] According to a third aspect of the present invention, there is provided a method for controlling the pressure provided to a dressing in a negative pressure wound therapy system, comprising: monitoring an applied pressure provided to the dressing; establishing a desired pressure range at the dressing through an establishment phase implemented with a microcontroller, wherein the microcontroller selectively powers a pump assembly to provide negative pressure to11 170534979vlthe dressing during the establishment phase; executing a pressure maintenance phase with the microcontroller when the applied pressure is within the desired pressure range; and providing an indication when the pressure maintenance phase is outside of maintenance phase parameters.

[0057] Before executing the establishment phase, the microcontroller may ensure current battery voltage exceeds a minimum threshold. Before executing the establishment phase, the microcontroller may ensure it has not been operating for greater than a time threshold. During the establishment phase, the microcontroller may determine whether a leak is detected. The method may be initiated when the microcontroller is powered and receives an input from a button and may be paused with a pause input signal from a button. The microcontroller may provide an indication if a leak is detected or if battery voltage is less than a voltage threshold. The microcontroller may pause the pump assembly if a leak is detected. The microcontroller may pause the pump assembly if a leak is detected and execute a self-test to ensure operating parameters are acceptable prior to therapy. During the pressure maintenance phase, the microcontroller may monitor the applied pressure to ensure it remains in the desired range. During the pressure maintenance phase, the microcontroller may monitor the applied pressure to ensure it remains in the desired range, and monitor when user interaction with the dressing or a leak moves the device out of this phase. The microcontroller may refrain from powering the pump assembly if the system exceeds a time threshold. The microcontroller may refrain from powering the pump assembly if the system exceeds a time threshold and enters a fault state, disabling use if a fault is identified during the establishment phase. The microcontroller may flash an indicator in a first form when powered and operating normally. The microcontroller may flash the indicator in a second form if a leak is identified. The second form may be different from the first form. The microcontroller may flash the indicator in a low battery form if power falls below a power threshold. The microcontroller may selectively power the pump assembly with a pulse width modulated signal. The pulse width modulated signal may be chosen for quiet operation and minimal power consumption. The pulse width modulated signal may be supplied to a Field Effect Transistor. The microcontroller may selectively wirelessly communicate data with an external device. The microcontroller may log errors upon fault detection. The microcontroller may log errors using a brown-out detection protocol to manage cooldown on power failure. Two pump assembly control field-effect transistors may be selectively powered. Two pump assembly control field-effect transistors may be selectively powered; such that both must be powered for operation. The vacuum pump drive signal12 170534979vlmay be pulse width modulated. The vacuum pump drive signal may be fed back to confirm expected pump driving.

[0058] According to a fourth broad aspect of the present invention, there is provided a method. The method may be a method of manufacturing a pump assembly. The pump assembly may be for providing a negative pressure to a wound dressing. The method may involve assembling a housing containing a pump. The pump may be a diaphragm pump. The pump may be selectively powered by a motor. The method may involve connecting a microprocessor to the motor. The method may involve connecting a microprocessor to the motor to selectively power the pump. The method may involve coupling a manifold to the pump. The method may involve coupling the manifold to the pump to direct negative pressure generated by the pump to a connector. The method may involve coupling a pressure sensor to the manifold. The method may involve electrically coupling the pressure sensor to the microprocessor. The method may involve electrically coupling the pressure sensor to the microprocessor to communicate a value representative of the pressure in the manifold to the microprocessor. The method may involve executing a calibration step. The method may involve executing a calibration step with the external pressure sensor. The method may involve executing a calibration step comprising operating the pump assembly while the connector is coupled to the external pressure sensor. The method may involve loading calibrated software generated in part during the calibration step to be executed by the microprocessor.

[0059] According to a fourth aspect of the present invention, there is provided a method of manufacturing a pump assembly for providing a negative pressure to a wound dressing, comprising: assembling a housing containing a pump selectively powered by a motor; connecting a microprocessor to the motor to selectively power the pump; coupling a manifold to the pump to direct negative pressure generated by the pump to a connector; coupling a pressure sensor to the manifold and electrically coupling the pressure sensor to the microprocessor to communicate a value representative of the pressure in the manifold to the microprocessor; executing a calibration step comprising operating the pump assembly while the connector is coupled to an external pressure sensor; loading calibrated software generated in part during the calibration step to be executed by the microprocessor.

[0060] The calibration step may include connecting the connector to a leak tester for a leak test calibration. The manufacturing test software may be partially updated with the calibrated software upon calibration completion. The external pressure sensor may connect to the microprocessor13 170534979vlthrough a serial communication port in the battery compartment. After loading the calibrated software, the pump assembly may be packaged. After loading the calibrated software, the pump assembly may be packaged in a sealed box or bag Verified product software may be established after calibration. Verified product software may be established after calibration, replacing the manufacturing test software.

[0061] According to a fifth broad aspect of the present invention, there is provided a pump assembly. The pump assembly may be for providing negative pressure to a wound dressing. The pump assembly may comprise a housing. The pump assembly may comprise a pump. The pump may be a motor-driven diaphragm pump. The pump assembly may comprise a manifold. The manifold may be fluidly coupled to the pump. The manifold may be fluidly coupled to the pump within the housing. The manifold may have a manifold body. The manifold may have a connector. The connector may be flexibly attached to the manifold body. The pump assembly may have a sensor fitted into the connector.

[0062] According to a fifth aspect of the present invention, there is provided a pump assembly for providing negative pressure to a wound dressing, comprising: a housing; a pump; a manifold fluidly coupled to the pump within the housing, the manifold having: a manifold body, and a connector flexibly attached to the manifold body; and a sensor fitted into the connector.

[0063] The connector is flexibly attached to the manifold body meaning that the connector can pivot / move with respect to the manifold body and that loads supplied by the pressure sensor to the manifold can be absorbed. The manifold body and the pressure sensor mounted on the printed circuit board are connected via an extended non rigid feature (e.g., the connector) on the manifold. This feature provides the degrees of freedom required to couple the pressure sensor nipple onto the manifold subassembly with positional fluidity to allow any shift during assembly or usage of the pump assembly.

[0064] This means that for example during assembly of the pump assembly when the pressure sensor is fitted into the connector the manifold is less likely to move as a result of non-perfect alignment of the pressure sensor with the connector, meaning that the manifold does not move out of a desired position in which all connectable interfaces are successfully engaged. This has a number of benefits, including, for example, that the manifold is less likely to rotate about where it may be coupled to the housing due to poor alignment of the pressure sensor with the housing during assembly. Further, during use, the flexible attachment between the manifold body and14 170534979vlconnector means that the manifold can be more absorbent of a load supplied to it by a circuit board attached to the pressure sensor when the circuit board itself receives a load (for example from a vibration or impact), meaning the manifold is less likely to migrate out of the desired position. The flexible attachment also provides improved leak protection. Imperfect alignment can lead to leaks; Rather than ensuring perfect alignment of each opening of a manifold with a corresponding mating surface, which could be difficult or impossible, at least without increased cost / weight etc., providing a flexible connection between at least one connector and the manifold body, accommodates for imprecise alignment during mating and ensures a leak-tight connection. All in all, the flexibly attached connector provides mechanical robustness against leakage due to misalignment during assembly, impact, and / or vibration.

[0065] The connector may be flexibly attached to the manifold body so that the connector may move with respect to the manifold body. The connector may be flexibly attached to the manifold body so that the connector may pivot with respect to the manifold body. The connector may be resiliently flexibly attached to the manifold body. The connector may be a hollow connector. The connector may be a hollow projection extending from the manifold body. Preferably, the connector projects outwardly from the manifold body. Preferably, the connector projects outwardly from the manifold body in a radial direction. However, alternatively, in some embodiments, the projection projects inwardly into the manifold.

[0066] The connector may be attached to the manifold body by a flexible joint. The flexible joint may permit the connector to move or pivot. The flexible joint may be resiliently deformable. The flexible joint may be resiliently flexible.

[0067] An outer surface of the manifold may comprise a depression. The connector may be located within the depression. The depression may comprise a base. The base may be the flexible joint. The flexible joint may be an annular portion extending outward from the connector. The flexible joint may surround the connector. The flexible joint maybe formed in the manifold. The depression may taper outwardly from the base. The depression may diverge outwardly from the base. The depression may comprise an exit. The depression may extend from the base to the exit. The depression may diverge outwardly from the base to an exit of the depression. The connector may extend from the base to or beyond the exit of the depression.

[0068] The connector may be straight. The connector may be substantially cylindrical or frustoconical. The connector may comprise an open-ended passage. The sensor may be received15 170534979vlin the open-ended passage. The open-ended passage may have a constant or varying diameter. The open-ended passage may have an opened-ended passage diameter. The open-ended passage diameter may be less than other manifold openings of the manifold.

[0069] The manifold may be fluidly couplable to the wound dressing. The manifold may be fluidly couplable to the wound dressing via a fluid connector attached to the housing.

[0070] The housing may comprise a housing body and the fluid connector. The fluid connector and housing body may be integrally formed. The fluid connector may extend from the housing. The manifold may be fitted in or over the fluid connector. The fluid connector may be connectable to tubing fluidly coupled to the negative pressure wound dressing. The housing body and connector may be formed as one piece. The fluid connector may comprise a Luer fitting. The Luer fitting may comprise a female Luer fitting.

[0071] The integrally formed housing and fluid connector adds strength / robustness as well as protection against the possibility of leaks into the housing.

[0072] The pump assembly may comprise a printed circuit board assembly (PCBA). The PCBA may comprise a controller. The controller may be a microprocessor. The PCBA may be positioned over the manifold. The PCBA may comprise the sensor and a circuit board. The sensor may extend from the circuit board into the connector.

[0073] The sensor may extend through the connector into an interior of the manifold body. The sensor may be a pressure sensor. The pressure sensor may be operable to measure a parameter indicative of pressure. The protruding portion of the sensor may be made of a flexible material to further absorb motion imparted by vibration and impact during use of the pump assembly without the sensor detaching from the connector.

[0074] The pump may comprise a suction element (e.g., a diaphragm pump). The assembly may further comprise a motor. The motor may be for powering the pump. The motor may be for powering the suction element.

[0075] Foam may be provided within the housing. The foam may be provided on the pump. The foam may be provided on the motor. The foam may be provided on the suction element of the pump. The foam may be provided in one or more parts. The foam may be silicone foam. The foam may be low density silicone foam. The foam may be BISCO BF-1000. The foam may have a density in the range of 8 to 14 PCF. The foam may have a density of 12 PCF . The foam may be closed cell or open cell. The foam may be acoustic foam.16 170534979vl

[0076] The pump may be batery powered. The pump may be powered by one or more bateries. The one or more bateries may comprise one or more replaceable bateries. The one or more bateries may comprise one or more rechargeable bateries. The one or more bateries may comprise one or more alkaline or lithium bateries. The one or more bateries may comprise one or more AA bateries, which are preferably rechargeable. The one or more bateries may power the motor.

[0077] The connector and manifold body may be integrally formed. The connector and manifold body may be integrally formed by casting or molding. The connector and manifold body may be formed as one piece. The connector and / or manifold body may be monolithically formed from a material. The material may be resiliently flexible material. The material may be an elastomeric material. The elastomeric material may be a synthetic or natural rubber. The material may comprise plastic. The plastic may be thermoplastic. Preferably, the material comprises a Thermoplastic Elastomer (TPE), such as TPV and TPU.

[0078] A push fit connection may be formed between the connector and the sensor. The resiliently flexible material may define the open-ended passage. The open-ended passage may be resiliently deformable. The connector may be compressed against an outer surface of the pressure sensor. An inner surface of the connector may be compressed against an outer surface of the sensor. This is as a result of the sensor expanding the size of the open-ended passage when it is fited therein, leading to a tight seal between the inner surface of the connector and the sensor.

[0079] The open-ended passage may be expanded from a natural rest state by receiving the sensor.

[0080] The manifold may be fluidly couplable to the wound dressing. The manifold may be fluidly couplable to the wound dressing via a fluid connector of the housing.

[0081] The manifold may have a pump opening coupled to the pump, e.g. a diaphragm pump. The manifold body may comprise a housing opening coupled to a housing connector of the housing. The housing connector may be the fluid connector. The hollow connector may be located between the pump opening and the housing opening. The pump opening may have a pump opening axis. The housing connector may have a housing connector axis. The pump connector axis may be co-directional with the housing connector axis. The pump opening axis and housing opening axis may be the same. The open-ended passage may have a passage axis. The passage axis may be orthogonal to the pump opening axis and / or the housing opening axis.17 170534979vl

[0082] The manifold may further comprise a check valve that allows one directional flow of air. The check valve may be configured to be positioned between the dressing and the pump when the pump assembly provides negative pressure to the wound dressing. The directional position of the check valve seated inside the manifold determines the airflow direction. The check valve may be positioned between the manifold and the diaphragm pump to hold the negative pressure inside the manifold assembly.

[0083] The manifold may further comprise a pressure relief valve (PRV) connected with the pump. The pressure relief valve may be located fluidly between the check valve and the pump (e.g., a diaphragm pump) providing negative pressure to the wound dressing. Alternatively, the pressure relief valve may be positioned to be disposed between the dressing and the check valve within the manifold when the pump assembly provides negative pressure to the wound dressing. The pressure relief valve may be a coil spring and plunger assembly comprising a cracking pressure threshold in a range of between about -2.0 to -4 PSI, or between about -100 to -205 mmHg.. The pressure relief valve opening to disrupt fluid flow within the manifold at the negative pressure limit threshold (e.g., the cracking pressure) prevents the pump from generating excessive levels of negative pressure at the wound bed, such as a maximum negative pressure level associated with outer limit of beneficial treatment.

[0084] The manifold may comprise a main hollow portion. The main hollow portion may comprise the check valve. The manifold may comprise a subset of the manifold branched out from the main hollow portion and the check valve may be disposed in the main hollow portion of the manifold. The main hollow portion may be positioned between the pump and the dressing when the pump assembly provides negative pressure to the wound dressing. A hollow branch may branch off the main hollow portion between the check valve and the pump. The hollow branch may comprise the pressure relief valve disposed therein.

[0085] The pressure relief valve may be provided at a free end of the hollow branch. Part of the hollow branch may extend parallel to the main hollow portion. An outlet axis of the pressure relief valve may be parallel to the housing opening axis. The hollow branch may comprise a head. The neck may extend from the main hollow portion to the head. The head may comprise the pressure relief valve. A width of the hollow branch may increase from where the hollow branch branches off the main hollow portion to the pressure relief valve.18 170534979vl

[0086] The specific arrangement of the pressure relief valve fluidly between the check valve and pump provides greater robustness against manufacturing tolerances. The manifold with the specifically arranged pressure relief valve may be particularly easily positioned within the housing during assembly so that all interfaces are securely mated and less likely to disengage. This means the overall assembly is less sensitive to manufacturing tolerances.

[0087] The pressure relief valve may be configured to open when a negative pressure limit threshold (e.g., the cracking pressure threshold) is reached by the pump within the manifold. The negative pressure limit threshold prevents the pump from generating excessive levels of negative pressure at the wound bed. The pressure relief valve may be configured to relieve negative pressure output by the pump to the wound dressing when the negative pressure limit threshold is reached. The pressure relief valve may be a coil spring and plunger assembly comprising a cracking pressure threshold in a range of between about -2.0 to -4 PSI, or between about -100 to -205 mmHg.

[0088] The suction element may be driven by the motor. The suction element may comprise a diaphragm. The diaphragm may be located within a pump housing of the pump. The suction element may be a diaphragm pump . The diaphragm pump may be driven by the motor.

[0089] The assembly may comprise one or more electrical lights. The PCBA may comprise the one or more electrical lights. The one or more electrical lights may be configured to emit light. The one or more electrical lights may be configured to emit light when an instruction from the controller is received. The one or more electrical lights may be located inside the housing. The one or more electrical lights may be located inside the housing. The housing may be translucent so the one or more electrical lights can be seen from an exterior of the housing when they emit light.

[0090] A portion of the housing covering the one or more electrical lights may be thinned. The portion of the housing covering the one or more electrical lights may be thinned relative to the rest of the housing. The top cover may comprise the portion of the housing covering the one or more electrical lights. The portion may be thinned relative to the rest of the top cover. The portion may be a translucent portion. The housing may further comprise a non-translucent portion. The translucent portion may be thinner than the non-translucent portion. The top cover may comprise the non-translucent portion and the translucent portion.

[0091] One or more markings may be provided on an external portion of the housing. One or more markings may be provided on an external portion of the housing in the region covering the one or19 170534979vlmore electrical lights. Preferably, there are three electrical lights and three marks on the external portion of the housing in the region covering the three electrical lights. A first of the three marks may be a check mark. A second of the three marks may be an exclamation mark. A third of the three marks may be a battery symbol. The one or more electrical lights may be one or more light emitting diodes (LED)s.

[0092] The housing may comprise the housing body and a top cover removably coupled to the housing body. The top cover may be the portion of the housing covering the one or more electrical lights. The top cover may comprise the one or more markings.

[0093] According to a sixth aspect of the present invention, there is provided a negative pressure wound therapy apparatus, comprising: the pump assembly of any of the first broad aspect, second broad aspect, fifth broad aspect, first aspect, second aspect or fifth aspect of the invention. The negative pressure wound therapy apparatus may further comprise a wound dressing. The wound dressing may comprise foam. The wound dressing may comprise polyester foam. The negative pressure wound therapy apparatus may further comprise a fluid conduit between the dressing and the pump assembly. The fluid conduit may comprise medical tubing. The negative pressure wound therapy apparatus may be canisterless. The negative pressure wound therapy apparatus may be portable. The negative pressure wound therapy apparatus may further comprise a belt clip for clipping the pump assembly to a belt.

[0094] According to a seventh aspect of the present invention, there is provided a method of manufacturing a pump assembly for providing negative pressure to a wound dressing, the method comprising: providing a housing; providing a pump; providing a manifold comprising a manifold body and a connector flexibly attached to the manifold body; fluidly coupling the manifold to the pump within the housing; and fitting a pressure sensor into the connector.

[0095] The method may further comprise coupling the manifold to the housing. Coupling the manifold to the housing may comprise coupling the manifold to a housing connector of the housing.

[0096] The method may further comprise providing a printed circuit board assembly (PCBA). The PCBA may be positioned over the manifold when the sensor is fitted into the connector. The PCBA may comprise the sensor and a circuit board. The sensor may extend from the circuit board into the connector. The sensor may be a pressure sensor. The PCBA may coupled to a controller. The controller may be a microprocessor.20 170534979vl

[0097] The pump may comprise a suction element. The suction element may be driven by the motor. The suction element may be a diaphragm pump element. The diaphragm pump element may be driven by the motor.

[0098] The pump housing and manifold may consist of six or less assembled molded parts. The pump housing and manifold may consist of five or less assembled molded parts.

[0099] The pump assembly may be the pump assembly of the fifth aspect.

[0100] According to an eighth aspect of the present invention, there is provided a pump assembly of the first broad, second broad, fifth board aspect, first aspect, second aspect or fifth aspect, having six or less molded parts. The molded parts may be molded from plastic. The molded parts may comprise composite parts molded from different materials. Each composite part may comprise a first portion formed from a first plastic. Each composite part may further comprise a second portion formed from a second plastic. The first plastic may be more rigid than the second plastic. The second plastic may be elastomeric. The second portion may be a seal. The seal may be applied to the first portion by an overmolding process. Preferably, the six molded parts comprise at least two composite parts.

[0101] According to a ninth aspect of the present invention, there is provided a method of manufacturing a pump assembly for providing a negative pressure to a wound dressing, the method comprising: integrally forming a housing and a connector; fluidly coupling a manifold with a pump; and fluidly coupling the manifold with the connector.

[0102] The housing and connector may be formed as one piece. The housing and connector may be molded monolithically as one piece. The housing and connector may be cast as one piece. The housing and connector may be formed simultaneously. The housing and connector may be formed of plastic. The pump assembly may be the pump assembly of the first aspect.

[0103] According to a tenth aspect of the present invention, there is provided a method of manufacturing a pump assembly for providing a negative pressure to a wound dressing, the method comprising: forming a housing comprising a housing body and a top cover removably coupled to a housing body to define a sealed interior, wherein the method further comprises integrating an operational button into a top cover of the housing such that the interface between the operational button and the top cover provides a fluid-tight transition from the surrounding environment to the sealed interior around the operational button.

[0104] Forming the housing may comprise overmolding the operational button on the top cover.21 170534979vl

[0105] The top cover may comprise a cover gasket. Forming the housing may comprise overmolding the cover gasket on the top cover. The cover gasket may form a loop that extends parallel to a perimeter of the top cover. The method may comprise integrally forming the cover gasket and operational button. The method may comprise overmolding the operational button and cover gasket to the top cover. The method may comprise overmolding the operational button and cover gasket to the top cover simultaneously. The method may comprise overmolding the operational button and cover gasket as one piece.

[0106] The method may comprise locating a pump within the housing.

[0107] The pump assembly may be the pump assembly of the second aspect.

[0108] The skilled person will appreciate that, except where mutually exclusive, a feature described in relation to any one of the aspects, embodiments or examples of the present disclosure may be applied mutatis mutandis to any other aspect, embodiment or example of the present disclosure. Furthermore, except where mutually exclusive, any feature described herein may be applied to any aspect and / or combined with any other feature described herein.BRIEF DESCRIPTION OF THE DRAWINGS

[0109] The above-mentioned aspects of the present disclosure and the manner of obtaining them will become more apparent and the disclosure itself will be better understood by reference to the following description of the embodiments of the disclosure, taken in conjunction with the accompanying drawings, wherein:

[0110] Fig. 1 is a view of a first embodiment of a pump assembly fluidly coupled to a wound dressing through a tube set;

[0111] Fig. 2 is an elevated perspective front view of a negative pressure wound therapy pump assembly with a belt clip coupled thereto;

[0112] Fig. 3 is a lowered perspective front view of a negative pressure wound therapy pump assembly with a belt clip coupled thereto;

[0113] Fig. 4 is an elevated perspective back view of a negative pressure wound therapy pump assembly with a belt clip coupled thereto;22 170534979vl

[0114] Fig. 5 is an elevated perspective back view of a negative pressure wound therapy pump assembly without a belt clip coupled thereto;

[0115] Fig. 6 illustrates a front, right side, back, and left side view of the negative pressure wound therapy pump assembly;

[0116] Fig. 7 illustrates a top and bottom view of the negative pressure wound therapy pump assembly;

[0117] Fig. 8 illustrates a back view of the negative pressure wound therapy pump assembly with a battery cover removed;

[0118] Fig. 9 illustrates a front view of the negative pressure wound therapy pump assembly with a top cover removed;

[0119] Fig. 10 illustrates a front view of the negative pressure wound therapy pump assembly with a top cover and a printed circuit board assembly removed;

[0120] Fig. 11 illustrates a motor, pump, and manifold of the negative pressure wound therapy pump assembly isolated from remaining components thereof;

[0121] Fig. 12 is a cross-sectional horizontal and vertical view of the interface between a pump assembly and a manifold of the negative pressure wound therapy pump assembly;

[0122] Fig. 13 is a cross-sectional horizontal view of a pump assembly, manifold, and housing of the negative pressure wound therapy pump assembly;

[0123] Fig. 14 is an exploded view of the negative pressure wound therapy pump assembly;

[0124] Fig. 15 is a detailed view of a manifold and adjacent housing of the negative pressure wound therapy pump assembly;

[0125] Fig. 16 is a schematic view of a method for controlling a pressure of the negative pressure wound therapy pump assembly;

[0126] Fig. 17 is a schematic view of an operational control logic of the negative pressure wound therapy pump assembly;

[0127] Fig. 18 is a schematic view of an operational mode logic of the negative pressure wound therapy pump assembly;

[0128] Fig. 19 is a method of manufacturing the negative pressure wound therapy pump assembly

[0129] Fig. 20A shows a front perspective view of a second embodiment of a pump assembly according to the present invention;

[0130] Fig. 20B shows a rear perspective view of the pump assembly of Fig. 20A;23 170534979vl

[0131] Fig. 20C shows a front exploded view of the pump assembly of Fig. 20 A;

[0132] Fig. 20D shows a rear exploded view of the pump assembly of Fig. 20 A;

[0133] Fig. 20E shows a detail view of a top cover of the pump assembly of Fig. 20A

[0134] Fig. 21 A shows a cross-sectional view of a pump assembly according to a third embodiment of the present invention;

[0135] Fig. 21B shows a perspective view of a manifold of the pump assembly of Fig. 21 A; and

[0136] Fig. 22 shows a pump assembly according to a fourth embodiment of the present invention.DETAILED DESCRIPTION

[0137] The embodiments of the present disclosure described below are not intended to be exhaustive or to limit the disclosure to the precise forms in the following detailed description. Rather, the embodiments are chosen and described so that others skilled in the art may appreciate and understand the principles and practices of the present disclosure.

[0138] Referring now to the figures, and specifically to FIG. 1, one embodiment of a wound exudate management system 10 is shown. The wound exudate management system 10 of this embodiment has a wound dressing 14, a pump 18 and a tube 22 (also referred to as a tube set). Generally, the wound exudate management system 10 facilitates wound healing and wound protection. The dressing 14 is applied to the skin of a user, as will be described below, and the system 10 utilizes negative pressure generated by the pump 18 to aid wound healing. The dressing 14 and the pump 18 are fluidly connected via the tube 22. Negative pressure generated by the pump 18 is communicated to the dressing 14 by the tube 22, thereby enabling the dressing 14 to employ negative pressure for enhanced wound healing.

[0139] In various embodiments, the pump 18 operates to generate negative pressure in response to a variety of user inputs. In one embodiment, a user control for the pump 18 is disposed on the pump 18 and / or remote to the pump 18. The user control may be one or more of a button, switch, lever, sensor or any other control device. The pump 18 may also have one or more indicators disposed on the pump 18 for apprising the pump user of a current operational status, condition, battery life, etc. of the pump 18. The indicators may be lights including Light-Emitting Diodes (LEDs), however any other type of indicator may be used such as a speaker for generating an audible sound or a motor with a radially asymmetric flywheel for generating a vibration.24 170534979vlInstructional indicia may be associated with one or more of the indicators for apprising a user of the significance of an operation of a particular indicator. In some implementations, however, the pump 18 operates without a user input and generates negative pressure in response to a timer, remote signal, sensor reading or other stimulus as described herein in more detail.

[0140] In one embodiment, prior to operation of the pump 18, the indicators for the pump 18 are preferably not illuminated. In such a state, the pump 18 is generally not generating negative pressure, which may correspond to the pump 18 being in an off condition. Further, in one embodiment, when all of indicators transition to an illuminated state, the pump 18 is preferably in a ready state and is ready for use. Further, in one embodiment, when one indicator remains in an illuminated state and the remaining indicators transition to a non-illuminated state, this is an indication that the pump 18 is in an operating state. Normal operation of the pump 18 may include the generation of negative pressure, alternating periods of negative pressure generation, and / or no generation of negative pressure. The pump 18 may transition between one or more of the off condition, ready state and operating state as a result of manipulation of the user control. Manipulation of the user control to change the pump state may include and / or require manipulation of the user control for a predetermined amount of time.

[0141] In one embodiment, the pump 18 generates negative pressure until a first pressure threshold is reached. The pump 18 may then refrain from generating negative pressure until a second threshold pressure is reached, at which point the pump 18 may generate negative pressure until the first pressure threshold is again reached. Alternate operations of the pump are allowable.

[0142] In one embodiment, as shown in FIG. 1, the pump 18 is connected to the pressure tube 22 with a pump connector 38. The pump connector 38 may allow for selective separation of the pump 18 and the tube 22.

[0143] In one embodiment, the tube 22 comprises a distal tube portion 40 and a proximal tubular portion. The proximal tubular portion may be an extension of the flexible connector 50. A separable connector 44 may join the distal tube portion 40 and the proximal tubular portion. The pump connector 38 connects one end of the tube 22, and preferably the distal tube portion 40 of the tube 22, to the pump 18, as shown in FIG. 1. However, in an alternate embodiment, not shown, the pump connector 38 may connect the proximal tubular portion to the pump 18. In one embodiment, the distal tube portion 40 forms a portion of the pressure tube 22 and may be flexible,25 170534979vltransparent, partially -transparent, and / or formed from a polymer, metal, metal alloy or any other suitable material.

[0144] The dressing 14, in some implementations, includes a backing layer 82, pressure dispensing layer 104, wound contact layer, absorbent material layers, and the flexible connector 50, among other things. Further, the wound dressing 14 may have an inner envelope structure. The inner envelope structure may house a plurality of layers of absorbent material to aid in exudate management. In one embodiment, the inner envelope structure 100 is defined by an upper envelope layer and a lower envelope layer. The upper envelope layer may have a peripheral section 108 and a central section 109. The peripheral section 108 of the upper envelope layer may also be referred to as the upper peripheral section 108, and the central section 109 of the upper envelope layer may also be referred to the upper central section 109. Similarly, the lower envelope layer may have a peripheral section and a central section.

[0145] In addition to the embodiment illustrated in Fig. 1, the tube set and wound dressing contemplated herein may be similar to those illustrated and described in International Application No. PCT / GB2023 / 052930 filed September 6, 2024; International Application No. PCT / GB2016 / 053295 filed October 21, 2016; and International Application No. PCT / US2017 / 031817 filed May 9, 2017; among other wound dressings and tube sets known at the time of this disclosure. The contents of these disclosures being incorporated herein by reference in entirety.

[0146] Figs. 2-4 illustrate several views of a first embodiment of a pump assembly 200 for this disclosure that improves the functionality of the wound exudate management systems known at the time of this disclosure, among other things. More specifically, the pump assembly 200 may have a housing 202 with a top cover 204 coupled thereto. The pump assembly 200 is equipped with an operational button 206 integrally formed in the top cover 204 that allows user interaction with the pump assembly 200 to implement pump logic control systems and otherwise provide user interaction with the pump assembly 200 to monitor or request the operating condition of the pump assembly 200, among other things.

[0147] In one aspect of this disclosure, a belt clip 208 is selectively attachable to the pump assembly 200, providing portability for the user by enabling the pump assembly 200 to be secured to a belt or other attachment point of the user. Further, the pump assembly 200 may be selectively removed from the belt clip 208 while the belt clip 208 remains on the user. This allows the user to26 170534979vleasily attach / detach the pump assembly 200 from the belt clip 208 to view and / or alter the operation of the pump assembly 200.

[0148] In another aspect of this disclosure, the pump assembly 200 may have a connector 210 integrated into the pump assembly 200 through the housing 202. The connector 210 provides a location to fluidly couple the pump assembly 200 to a tube set. In one example, the connector 210 is configured to be coupled to the pump connector 38 of tube 22 to be further coupled to the flexible connector 50 of the wound dressing 14. However, while a specific wound dressing and tube set are described herein, the teachings of this disclosure apply to any known wound dressing and tube set that may be effectively utilized with the pump assembly 200 disclosed herein.

[0149] Referring now to Fig. 5, a back side view of the pump assembly 200 illustrates a battery cover 402, which provides closure for the compartment housing the pump assembly's 200 power source. Among other things, the battery cover 402 protects any batteries within the pump assembly 200 within a sealed interior region as is discussed in more detail herein. More specifically, the periphery of the battery cover 402 may be configured to sealingly engage the corresponding section of the housing 202 to ensure the battery cover 402 seals an interior portion containing the batteries from the surrounding environment when the battery cover 402 is properly coupled to the housing 202. Further, the battery cover 402 may be easily removable by a user through a latch and release relationship between the battery cover 402 and the housing 202.

[0150] Figures 6-8 depict multiple views of the same embodiment of the pump assembly 200. Fig.6 offers a comprehensive view from various angles, including a front view 502, right side view 504, back view 506, and left side view 508. These views collectively illustrate the spatial configuration and external aesthetics of the pump assembly 200.

[0151] Fig. 7 provides the bottom view 700 and top view 702 of the pump assembly 200. These views show the outer contours and any potential functional or design elements located at the top and bottom of the housing 202 and corresponding components coupled thereto. As illustrated in Fig. 7, the pump assembly 200 has a radius of curvature when viewed from the bottom view 700 or the top view 702. This radius of curvature is configured to allow the pump assembly 200 to discretely contour with a user's body in use. In one example, the radius of curvature may be about the same as that expected on an adult human at about the waist line when worn on a belt. In this configuration, when the pump assembly 200 is coupled to a user's belt via the belt clip 208, the27 170534979vlpump assembly 200 may naturally curve with the user's body. This may minimize the noticeability of the pump assembly 200 to third parties, among other things.

[0152] Fig. 8 illustrates an interior view of the housing 202, revealing an open battery compartment 800 wherein the battery cover 402 has been removed. The battery compartment 800 may have a battery gasket 802 positioned around the periphery of the battery compartment 800 such that the battery cover 402 may be selectively coupled thereto to seal batteries therein as discussed herein. This ensures, among other things, that the battery compartment 800 remains substantially sealed from the surrounding environment when the battery cover 402 is properly coupled to the housing 202.

[0153] Fig. 9 illustrates a technical view inside the housing 202 with the top cover 204 removed therefrom. Among other things, Fig. 9 illustrates a printed circuit board 900, along with various components such as a body gasket sealing surface 902 configured to engage a cover gasket 1400 and microprocessor 904, positioned within a sealed interior 906 of the housing. More specifically, the top cover 204 and battery cover 402 may be sealingly coupled to the housing 202 to ensure the sealed interior 906 remains isolated from the surrounding environment so the printed circuit board 900, batteries, and other components positioned within the housing 202 are not exposed to unfavorable conditions of the surrounding environment, such as moisture among other things. In other words, the sealed interior provides protective encapsulation of the components within the housing 202.

[0154] The printed circuit board 900 may also have Indicators 908, 910, and 912 that are selectively engageable with the microprocessor 904 to provide user feedback or operational status of the pump assembly 200. In one aspect of this disclosure, the printed circuit board 900 provides one or more coating to provide electromagnetic compatibility (EMC) shielding integrated as part of the printed circuit board 900. In one aspect of this disclosure, at least a portion of the printed circuit board 900 is coated with aluminum as EMC shielding. Alternatively, any known method of shielding the printed circuit board 900 may be applied herein as well.

[0155] Fig. 10 details the integration of internal components within the housing 202 with the printed circuit board 900 removed therefrom. Among other things, this emphasizes the orientation of a manifold 1000 with other components of the pump assembly 200. In one aspect of this example, a pump 1002 is selectively powered by a motor 1004 through the microprocessor 904. The manifold 1000 may distribute negative pressure to the components fluidly coupled thereto28 170534979vlwith its operation monitored via a pressure sensor coupled thereto via a pressure sensor interface 1005. The pressure sensor may be fitted into hole 1006.

[0156] In one aspect of this disclosure, the pump 1002 may be a diaphragm pump. However, any other known type of pump capable of providing the disclosed negative pressure is also contemplated herein. Further, the pressure sensor may be a pressure transducer that communicates with the microprocessor 904. Alternatively, the pressure sensor may be any known component capable of providing pressure measurements to the microprocessor 904.

[0157] In another aspect of this disclosure, one or more of the pump 1002 or the motor 1004 may have a foam material at least partially positioned between the pump 1002 and / or motor 1004 and the corresponding housing 202. In this configuration, the foam material may at least partially dampen the sound and vibration generated by the pump 1002 and motor 1004. Alternatively, this disclosure contemplates positioning any other known sound and / or vibration dampening material between the pump 1002 and / or motor 1004 and the corresponding housing 202 to dampen the sound and / or vibration when the pump assembly 200 is powering the pump 1002 and motor 1004.

[0158] The manifold 1000 may further provide a pressure relief valve interface 1007 having a pressure relief valve 1008 coupled thereto. The pressure relief valve 1008 may be configured to provide pressure relief when the negative pressure within the manifold exceeds a limit threshold. The pressure relief valve responding to the limit threshold prevents the pump from generating excessive levels of negative pressure at the wound bed. The pressure relief valve may be a coil spring and plunger assembly comprising a cracking pressure threshold in a range of between about -2.0 to -4 PSI, or between about -100 to -205 mmHg.

[0159] The manifold 1000 may also define a check valve interface 1010 configured to house a corresponding check valve (e.g., a one-way valve) to facilitate creation of a negative pressure when the motor 1004 engages the pump 1002. The manifold may also define a projection 1012 configured to allow the manifold 1000 to be properly aligned with the housing 202 during assembly, among other things.

[0160] The manifold 1000 may also define a vacuum pump interface 1014 configured to fluidly couple the manifold 1000 to the pump 1002 to distribute negative pressure therethrough when the pump 1002 is engaged by the motor 1004. Among other things, this allows the microprocessor 904 to selectively manage pressure and fluid flow within the assembly. The manifold 1000 is29 170534979vlultimately fluidly coupled to the connector 210 to provide a location to provide for fluid flow from the manifold 1000 to a tube set coupled to the connector 210, and ultimately to a wound dressing.

[0161] Fig. 11 presents a detailed view of the manifold 1000, linked to the motor 1004 and pump 1002 and isolated from the remaining components of the pump assembly 200. More specifically, the pressure sensor 1006 and pressure relief valve 1008 are illustrated coupled to the manifold 1000. The projection 1012 is also illustrated on the manifold 1000 in Fig. 11.

[0162] Figures 12 and 13 present sectional views that offer cross-sectional insights into the internal connections and seals of the components of the manifold 1000 and how the elements fit together within the pump assembly 200. Figures 12 and 13 illustrate one embodiment of the arrangement and interaction between the components of the pump assembly 200 discussed herein.

[0163] Referring now to Fig. 14, an exploded view of the pump assembly 200, illustrating the assembly and relative positioning of its components, including the body gasket sealing surface 902, sealing the sealed interior 906, and a cover gasket 1400. This view provides a comprehensive understanding of the assembly sequence and structural integration, which is pivotal for manufacturing and assembly processes. While the cover gasket 1400 is illustrated separated from the top cover 204, as discussed herein the cover gasket 1400 may be typically formed as part of the top cover 204 during an overmolding process when the top cover 204 is formed. In this configuration, the top cover 204 and cover gasket 1400 may substantially be a single integral component formed together.

[0164] Fig. 15 provides a detailed illustration of the interplay between the manifold 1000 and the adjacent housing 202 of the pump assembly 200. The manifold 1000 is configured to align accurately within the housing 202 through the use of the projection 1012. The projection 1012 is designed to correspond with a cutout 1500 defined in the housing 202. This configuration allows the manifold 1000 to be precisely aligned with the housing 202, ensuring proper fluid connections and structural integration of the manifold 1000 within the pump assembly 200. The cutout 1500 in the housing 202 facilitates this alignment by providing a predefined orientation with which the projection 1012 of the manifold 1000 can be aligned, thereby stabilizing and orienting the manifold 1000 in relation to the other components encased within the housing 202 and coupled thereto to ensure the manifold 1000 is fluidly coupled to the pump 1002, pressure sensor 1006, and connector 210, among other things. This structural relationship provides an easy reference during assembly that allows the manifold 1000 to be assembled with an orientation that allows for30 170534979vlmaintaining the integrity and performance of the fluid pathways within the system, among other things.

[0165] Referring now to Fig. 16, a schematic method of controlling pressure 1600 in a negative pressure wound therapy system utilizing the pump assembly 200 is illustrated. In one aspect of this disclosure, the microprocessor 904 may implement the control methods discussed herein. For example, the microprocessor 904 may have access to one or more memory unit, either stored locally on the printed circuit board 900 or accessed remotely through known wireless protocols., that stores executable steps for the microprocessor 904 to implement with the hardware components discussed herein. While one specific configuration for enacting the control steps discussed herein is disclosed, this disclosure contemplates utilizing any known hardware configuration to implement the method steps presented herein.

[0166] Regarding the method of controlling pressure 1600, the process begins with a monitor pressure 1602 step where the system continuously checks the current pressure levels applied to the wound dressing. In one aspect of this disclosure, the monitor pressure 1602 step is executed by the microprocessor 904 by monitoring the pressure sensor 1006. Alternatively, any other known method of monitoring pressure is contemplated herein for the monitor pressure 1602 step. Among other things, this phase ensures that feedback about the pressure within the manifold 1000 is accurately captured, enabling subsequent adjustments if needed.

[0167] Following the monitor pressure 1602 step, the microprocessor 904 may implement the step of establishing desired pressure 1604. In this part of the process, the microprocessor 904 selectively controls the motor 1004 and pump 1002 to reach a predefined pressure level suitable for effective wound therapy. In one aspect of this disclosure, the predefined pressure level may be around -80mmHg + / - 20mmHg. However, the teachings of this disclosure are contemplated for any suitable pressure range for negative pressure wound therapy. The microprocessor 904 manages the transition from the current pressure to the desired pressure by controlling the motor 1004 and pump 1002 operational parameters. In one aspect of this disclosure, the microprocessor 904 sends a pulse width modulated (PWM) signal to the motor 1004 to selectively power the pump 1002 with the most power efficient application of the motor 1004 and pump 1002 given the monitored and established pressures.

[0168] Further still, the microprocessor 904 may select a PWM signal to power the motor 1004 that is specifically selected based on the available power measured from the batteries. In this31 170534979vlconfiguration, the microprocessor 904 may select an ideal PWM signal that will both adequately power the pump 1002 and motor 1004 while ensuring they have sufficient power available from the batteries to function for the desired time period.

[0169] Next, the process involves an executing maintenance phase 1606 step. During this phase, the system maintains the established pressure within a specific range. In one aspect of this disclosure, the executing maintenance phase 1606 step utilizes the microprocessor 904 observing real-time feedback from the pressure sensor 1006 to determine whether the monitored pressure has fallen outside of the predefined pressure levels. In one aspect of this disclosure, the microprocessor 904 may selectively power the motor 1004 and pump 1002 to make any necessary adjustments to the monitored pressure, ensuring the pressure applied to the wound dressing remains within the predefined pressure level tolerances.

[0170] Finally, the method concludes with an indicating status 1608 step, where the system provides feedback to the user regarding the operational state of the pump assembly 200. In one example, the indicating status 1608 step is executed by the microprocessor 904 selectively sending signals to power one or more indicator 908, indicator 910, or indicator 912. In one example of this disclosure, the indicating status 1608 step may involve providing any one or more of a visual, auditory, or haptic signal indicating successful pressure maintenance or alerting the user to any issues, such as leaks or low battery levels, among other things. The indicator system ensures that the user is always informed about the system's performance, enhancing usability and patient comfort reassurance, among other things.

[0171] Fig. 17 shows one example of an operational control logic 1700 for managing various modes of the pump assembly 200 utilized for negative pressure wound therapy. The process begins with a batteries inserted 1602 step wherein the microprocessor 904 becomes powered, which triggers a startup check 1702. If the startup check 1702 fails, the system transitions to fault mode 1704. Successful startup leads to powered mode 1706.

[0172] The startup check 1702 may fail if the microprocessor 904 identifies insufficient power or that any of the electronic components coupled to the microprocessor 904 are not functioning as expected. In the fault mode 1704 the microprocessor 904 may utilize one or more indicator 908, indicator 910, or indicator 912 to identify the fault mode 1704. Further, the microprocessor 904 may pause or otherwise discontinue powering the motor 1004, among other electrical components of the pump assembly 200.32 170534979vl

[0173] If the startup check 1702 is successful, the microprocessor 904 executes a powered mode 1706. The powered mode 1706 may begin with checking for a diagnostic command 1708 that can selectively transition the pump assembly 200 to a diagnostic mode 1710. The diagnostic command 1708 may be initiated by an operator engaging the operational button 206 for a duration or sequence that will be identified by the microprocessor 904 to initiate the diagnostic mode 1710. The diagnostic mode 1710 may allow an operator to access otherwise limited information. In one aspect of this disclosure, in the diagnostic mode 1710 a user may obtain error logs and otherwise program or communicate with the pump assembly 200 either wirelessly via bluetooth or other known wireless protocols or via a physical connection.

[0174] If a diagnostic command is not issued, the system checks whether time has expired in the time expired 1712 step and transitions to expired mode 1714 if it has. The time expired 1712 step may provide a preset time threshold within which the microprocessor 904 is preset to provide a negative pressure with the pump assembly 200. For example, the pump assembly 200 may be programmed to operate for a maximum of 7 days, a maximum of 15 day, or a maximum of 30 days, among any number of days not specifically described. The time expired 1712 step may compare the operational time the pump assembly 200 has been applying a negative pressure to the maximum time threshold the pump assembly 200 has been pre-programmed to operate. If the operational time the pump assembly 200 has been operating exceeds the maximum time threshold, the microprocessor 904 may determine the pump assembly 200 should transition to the expired mode 1714.

[0175] The time expired 1712 step may also include checking with the microprocessor 904 whether the microprocessor is receiving expected signals or feedback from the remaining components of the pump assembly 200 within the expected response time. If the expected signals or feedback are not received, the microprocessor 904 may enter the expired mode 1714.

[0176] In one aspect of this disclosure, in the expired mode 1714 power may be substantially preserved and one or more indicator 908, indicator 910, or indicator 912 may provide an indication of the expired mode 1714 status of the pump assembly 200. Further, the motor 1004 may not be powered during the expired mode 1714 to avoid providing a negative pressure for a duration that exceeds the preset time threshold.

[0177] If the time expired 1712 step passes (i.e., the microprocessor 904 identifies appropriate responses within the time threshold), an error 1716 check may be initiated wherein the33 170534979vlmicroprocessor checks the electrical components for any unexpected responses. If the microprocessor 904 identifies an error during the error 1716 check, the microprocessor 904 may enter the fault mode 1704. However, if no error is detected in the error 1716 check, the microprocessor 904 may assume the pump assembly is ready for proper operation and await a button press 1718 from the operational button 206.

[0178] The button press 1718 may initiate the pump assembly 200 into an operational mode 1720 wherein the microprocessor 904 selectively controls and monitors the components of the pump assembly 200 to provide the desired negative pressure to the wound dressing, among other things. While in the operational mode 1720, the microprocessor 904 may continue to check for operational errors 1722 or a run time errors 1724. If any operational errors 1722 are detected, the system moves to fault mode 1704. Operational errors 1722 may include the motor 1004 or pressure sensor 1006 not providing the expected response to the microprocessor 904, among other things.

[0179] In the absence of any operational errors 1722, or substantially at the same time, the microprocessor 904 monitors the pump assembly 200 for run time errors 1724. Run time errors 1724 may be identified when the microprocessor 904 identifies that the pump assembly 200 has been operating for the expected application time for the pump assembly 200. In one example, the expected application time may be seven days. In another example, the expected application time may be fifteen days. In yet another example, the expected application time may be thirty days.

[0180] While specific expected application times are described herein, other expected application times are also considered herein. For example, expected application times may be less than seven days, or greater than thirty days. Further, the expected application time may be any specific time between seven days and thirty days. Further still, in other embodiments contemplated herein there may be no run time error 1724 check at all, and the pump assembly 200 may run the operational mode 1720 as long as there is adequate power and no operational errors 1722.

[0181] If the microprocessor 904 does not identify any operational errors 1722 or run time errors 1724 during the operational mode 1720, the operational mode 1720 may be executed until the button press 1718 is engaged.

[0182] Referring now to Fig. 18, one example of the operational mode logic 1800 is illustrated. The operational mode logic 1800 is implemented by the microprocessor 904 of the pump assembly 200 and designed to consistently provide the desired negative pressure to a wound dressing for a34 170534979vlnegative pressure wound therapy system. The diagram begins with the entry into the operational mode 1720 as discussed herein, which may typically be initiated through a button press 1718 of a powered pump assembly 200.

[0183] Once operational, the microprocessor 904 evaluates whether the pressure in the manifold 1000 is greater than a predetermined threshold at decision point 1802. In one aspect of this disclosure, the microprocessor 904 evaluates the pressure in the manifold 1000 by monitoring the pressure sensor 1006. If the pressure is greater than the expected threshold (for example, greater than -60mmhg), the microprocessor 904 proceeds to the pressure establishment phase 1804.

[0184] In the pressure establishment phase 1804, the microprocessor 904 engages the pump 1002 with the motor 1004 to lower the negative pressure applied to the wound dressing through the manifold 1000. The microprocessor 904 may provide a pulse width modulated signal to the motor 1004 to selectively power the pump 1002 to further reduce the negative pressure in the manifold 1000. The microprocessor 904 may power the pump 1002 with the motor 1004 during the pressure establishment phase 1804 and monitor whether the measured pressure in the manifold 1000 is within an expected pressure threshold (i.e., -80mmhg +-20mmhg) at decision point 1808. If the measured pressure is not within the expected threshold after the pressure establishment phase 1804 has been initiated for a time threshold, the microprocessor 904 may identify and issue and enter a standby 1810.

[0185] However, if the measured pressure is within the expected pressure threshold after the pressure establishment phase 1804, the microprocessor 904 may begin executing the maintenance phase 1606 as discussed herein. During this phase 1606, the system continuously monitors for conditions indicating a timeout or leak 1806. A timeout or leak may be identified when the measured pressure in the manifold 1000 is not within the expected threshold for a set time of operation. For example, if the microprocessor 904 powers the motor 1004 for a preset time and the pressure sensor 1006 does not show an expected pressure reading, the microprocessor 904 may assume a timeout or leak 1806 condition is present. If a timeout or leak is detected, the system transitions to standby 1810. Conversely, if no timeout or leak is detected, the process iterates back to reassessing the pressure conditions, among other things.

[0186] Referring now to Fig. 19, one embodiment of a method of manufacturing 1900 the pump assembly 200 is illustrated. The initial step involves assembling the housing 1902, which includes providing the housing 202, top cover 204 and operational button 206, and battery cover 402. As35 170534979vlmentioned herein, the housing 202, top cover 204 and operational button 206, and battery cover 402 are coupleable to one another to form a sealed interior 906 for the components of the pump assembly 200. The assembling the housing 1902 step may involve arranging the housing 202, top cover 204 and operational button 206, and battery cover 402 so they may be coupled to one another once the components are positioned within the sealed interior 906. The housing 202, top cover 204 and operational button 206, and battery cover 402 may be made of a material that ensures the structural integrity and durability of the pump assembly 200 and the integrity of the sealed interior 906. As discussed herein, one or more of the housing 202, top cover 204 and operational button 206, and battery cover 402 may be formed of materials such as PC / ABS and have one or more gasket molded therein at component interfaces to ensure the sealed interior 906 remains sealed from the surrounding environment. In one example contemplated herein, one or more of the gaskets discussed herein is formed of Santoprene and overmolded to the adjacent material. In implementations, the ingress protection (IP) rating of the housing 202 comprises an IP rating in a range of between IP22 to IP46.

[0187] Another step may involve placing and connecting the electronics 1904 and coupling the manifold components 1906. This step involves positioning the electronic components (printed circuit board 900, microprocessor 904, indicators 906, 908, 910, motor 1004, and pressure sensor 1006, among others) and manifold 1000 and corresponding components (pump 1002, pressure relief valve 1008, and check valve 1200, among others) within the housing 202. This includes electrically coupling the electronic components to communicate with the microprocessor 904 using known electronics manufacturing methods.

[0188] Similarly, the manifold 1000 components are fluidly coupled to the manifold to ensure fluid pressure is properly distributed and monitored from the pump 1002 to the connector 210 and ultimately through the tube 22 set to the wound dressing 14. As discussed herein, the manifold 1000 may have a projection 1012 defined thereon that corresponds with a cutout 1500 defined in the housing 202 to ensure the manifold 1000 is properly aligned with the connector 210 of the housing 202 and the pump 1002 to fluidly couple the manifold 1000 to the components coupled thereto.

[0189] After mechanical and electronic assemblies are completed, a tester may run a calibrating the assembly 1908 step. This involves powering the pump assembly 200 with an external pressure sensors coupled to the connector 210 to ensure accurate calibration of the pressure sensor 100636 170534979vland the system as a whole. The pump assembly 200 may be monitored via a wired connection to the serial communication port 804 or wirelessly. Regardless, the calibrating the assembly 1908 step may generate a calibration adjustment to be applied by the microprocessor 904 to ensure the pressure reading used by the microprocessor 904 from the pressure sensor 1006 are consistent with the external pressure used during the calibration.

[0190] The next step may involve loading calibrated software 1910 to the pump assembly 200, where the calibrated data compiled during the calibration step is integrated into the microprocessor 904 for subsequent use. The pump assembly 200 is then removed from external pressure sensors and prepared for shipping to an end user. This may involve packaging the pump assembly in a corresponding box or packaging, among other things.

[0191] With reference to Figures 20A to 20D, there is shown a pump assembly 10’ according to a second embodiment of the present invention. Like the first embodiment, the assembly 10’ includes a housing 11 ’ with a housing body 12’ and top cover 14’ removably coupled to the housing body 12’. Also, like the first embodiment, a pump 16’ comprising a motor 17’ for driving the pump 16’, a printed circuit board assembly (PCBA) 18’, a microprocessor coupled to a circuit board of the printed circuit board assembly 18’ and for selectively powering the pump 16’ are provided within the housing.

[0192] Like the first embodiment, the housing 11 ’ includes a connector 22’ which is formed in the material of the housing 11’ and fluidly coupled to the pump 16’. The connector 22’ of this embodiment is referred to as a fluid connector 22’. The fluid connector 22’ is for fluidly coupling the pump 16’ with a tube set (not shown) which in use is connected to a wound dressing. In this embodiment, like the first embodiment, the pump 16’ and fluid connector 22’ are fluidly coupled via a manifold 37’ located within the housing 11’. The fluid connector 22’ is monolithically formed in the material of the housing 11’ (in this case plastic). In other words, the fluid connector 22’ is integrally formed / molded with the housing. In particular, the housing body 12’ and fluid connector 22’ are integrally formed. Integrally forming the housing body 12’ and fluid connector 22’ provides improved leak protection as fluid cannot get between gaps between the connector and housing like in prior arrangements. Further, advantageously, the integral construction of the fluid connector 22’ with the housing body provides a particularly robust construction where, for example, the assembly 10’ is more likely to be able to function, if it is accidentally dropped by a user. The fluid connector 22’ of this embodiment (although not shown in detail in Figures 20A to37 170534979vl20E) has substantially the same construction as the fluid connector that will be described with reference to the third embodiment in connection with Fig. 21 A below.

[0193] As best shown in Figure 20D, the pump 16’ comprises a suction element 26’, which is driven by the motor 17’. The suction element 26’ of this embodiment is a diaphragm suction pump element. Foam is provided on the pump 16’, and specifically on both the suction element 26’ and the motor 17’. The foam is acoustic foam and specifically the foam is BISCO BF-1000. In this embodiment two pieces of the foam are provided 28a’, 28b’. One piece is provided on the motor 17’ and the other is provided on the suction element 26’. The foam helps to reduce the noise heard by the user during use of the assembly. Continuing to refer to Fig. 20D, the pump 16’ of this embodiment is battery powered and specifically by two replaceable AA batteries located within a battery compartment 32’ of the housing 11’. The battery compartment 32’ is closed by the battery cover 35’.

[0194] Referring now to Figure 20A, the top cover 14’ is removably coupled to the housing body 12’ to define a sealed interior within which the pump 16’, manifold 37’ and PCBA 18’ are located. An operational button 38’ is integrated into a top cover 14’ of the housing 11’ so that the interface 39’ between the operational button and the top cover provides a fluid-tight transition from the surrounding environment to the sealed interior around the operational button 38’. This effectively means that there are no gaps between the operational button 38’ and the top cover 14’, meaning that fluid cannot enter the sealed interior via the front of the top cover 14’. The fluid tight transition is accomplished by over molding the operational button 38’ to the top cover 14’. As best shown in Figure 20E, a reverse side of the top cover 14’ includes a cover gasket 42’. The cover gasket 42’ of this embodiment forms a loop that extends parallel to a perimeter of the top cover 14’, and is also formed in an over molding process with the top cover 14’. In this embodiment, the cover gasket 42’ and operational button 38’are integrally formed and formed in the same over molding process with the top cover 14’ . The cover gasket 42’ and operational button 38’ are thus seamlessly connected. As best shown in Fig. 20D, the battery compartment 32’ has a battery gasket 44’ extending around its periphery, which is formed in an overmolding process with the housing body 12’. In this embodiment, each of the cover gasket 42’, operational button 38’ and battery gasket 44’ are formed from an elastomeric material (e.g., Santoprene). In implementations, the ingress protection (IP) rating of the sealed housing 11 ’ comprises an IP rating in a range of between IP22 to IP46.38 170534979vl

[0195] As best shown in Fig. 20A, the housing 11 ’ and top cover 14’ are curved. The curve in the top cover 14’ means the pump assembly conforms better to a user’s form, meaning that it can be more easily worn about the user’s person. This improves the useability of the assembly 10’.

[0196] Referring now to Figure 20E (which shows a reverse side of the top cover 14’ in detail), an inner surface of the top cover 14’ comprises a plurality of ribs 48’. The plurality of ribs 48’ are located within the sealed interior when the top cover 14’ is removably coupled to the housing body 12’ of the housing. The plurality of ribs 48’ comprise sets of spaced apart ribs, which intersect each other to form crosses. Specifically, the plurality of ribs 48’ include longitudinally extending ribs 52’ and laterally extending ribs 54’ that form the crosses. In this embodiment, the form of the ribs are not the same. For example, one rib of the plurality of the ribs 55’ includes two cylindrically shaped fastener receiving portions 57’ that are formed to receive elongate fasteners (58’ in Figure 20D’) to secure the top cover to the housing body 12’.

[0197] Continuing to refer to Figure 20E, the operational button 38’ includes an operational button inner surface 56’, and the plurality of ribs comprises a first rib 58’ with a first part circular portion 60’, which partially surrounds the operational button inner surface 56’. In this embodiment, the operational button comprises a first interior projection 62’ which projects within the sealed interior. The first interior projection 62’ comprises a flange 64’ which underlies the first part circular portion 60 of the first rib 58’. In this embodiment (although not well shown in Fig. 20E) a second interior projection 65’with the same form as the first interior projection 62’ is provided. The ribs 48’ provide strength to the top cover 14’, ensuring that it is less likely to break when subjected to a significant load (for example, if the assembly is dropped or knocked) and less like to deform when fasteners are tightened to fixedly attach the top cover 14’ to the housing body 12’.

[0198] Referring to Figure 20C, the PCBA comprises three electrical lights 64’. In this embodiment the electrical lights are LEDS and are configured to emit light when an instruction from the microprocessor is received. The LEDS are located inside the housing 12’. The housing is translucent so the one or more electrical lights can be seen from an exterior of the housing when they emit light and specifically a portion of the housing covering the LEDS is thinned to accomplish this. Three marks 66’, 68’ and 70’ are provided on the external portion of the top cover 14’ in the region covering the three LEDS 64’. As best shown in Figure 20A, a first of the three marks 66’ is a check mark. A second of the three marks is an exclamation mark 68’ and a third of the three marks is a battery symbol 70’.39 170534979vl

[0199] The microprocessor (not shown) is operable to selectively turn the pump 16’ on when the operational button 38’ is pressed as it is in contact with the PCBA 18’. As shown in Figure 20D, the PCBA 18’ includes a pressure sensor 72’ which is fitted into the manifold 37’. The pressure sensor 72’ is in communication with the microprocessor.

[0200] The manifold 37’ comprises a check valve (not shown) and a pressure relief valve (not shown) in the same way as previously described with reference to the first embodiment.

[0201] With reference to Fig. 21 A there is shown a cross-sectional view of a pump assembly 10” according to a third embodiment of the present invention. The pump assembly 10” includes a housing 11” with a housing body 12” and top cover (not shown) as well as a pump, motor, microprocessor and PCBA 18”, like the second embodiment. The main difference between the third embodiment and the second embodiment is in the manifold 37”. Specifically, the manifold 37” includes a manifold body 39” and a (hollow) connector 41” into which the pressure sensor 72” of the PCBA is fitted. The hollow connector 41” is flexibly attached to the manifold body, meaning that the hollow connector 41” can pivot / move with respect to the manifold body 39”, meaning that loads supplied by the pressure sensor to the manifold 37” can be absorbed.

[0202] In this embodiment, the hollow connector 41” is resiliently flexibly attached to the manifold body 39”. This is due to the hollow connector and manifold body being integrally formed from an elastomeric material (specifically a Thermoplastic Elastomer, such as Thermoplastic Polyurethane (TPU) or Thermoplastic Vulcanizate (TPV)). As shown the hollow connector 41” is a hollow projection extending from the manifold body 39” and the hollow connector 41” projects outwardly from the manifold body 39” in a radial direction. In this embodiment, the hollow connector 41” is provided in a depression 43” in an outer surface 45” of the manifold 37”. The depression 43” has a base 47” and an exit 49”, and the hollow connector 41” projects just beyond the exit 49” of the depression 43”. The depression 43” diverges outwardly from the base 47” to the exit 49”. The base 47” is a flexible joint which extends around the connector 41” and connects the connector 41” with the manifold body 39’. The flexible joint therefore is formed as part of the manifold body 39”.

[0203] The hollow connector 41” is straight and substantially cylindrical (although other shapes are envisioned (such as a frustoconical connector)). In this embodiment, the hollow connector 41 ” includes an open-ended passage 51 ”, which has a constant diameter. As shown, the pressure sensor 72” extends from a circuit board 53” of the PCBA (which is positioned over the manifold 37”)40 170534979vlinto the open-ended passage 51”. The pressure sensor 72” expands the diameter of the open-ended passage 51” from its natural state, leading to the formation of a push fit connection between the hollow connector 41” and the pressure sensor 72”. In particular, an inner surface 54” of the hollow connector 41” is compressed against an outer surface of the pressure sensor 72”, leading to a tight seal between the inner surface of the connector and the sensor. As shown the pressure sensor 72” extends through the connector of the open-ended passage 51” into an interior of the manifold body 37”. The pressure sensor 72” is operable to measure a parameter indicative of pressure and feed this back to the microprocessor (not shown).

[0204] In this embodiment, the manifold body 37’ ’ has a pump opening 77’ ’ coupled to the pump (not shown) and a housing opening 79” coupled to a fluid connector 22” of the housing 11’. The hollow connector 41” is located between the pump opening 77” and the housing opening 79”. The pump opening 77” has a pump opening axis and the housing opening 79” has a housing opening axis. The pump opening axis is co-directional with the housing opening axis. The open-ended passage 51” has a passage axis which is orthogonal to the pump opening axis and the housing opening axis. The manifold 37” of this embodiment is shown in isolation in Figure 21B.

[0205] Like the second embodiment, the third embodiment includes a fluid connector 22” integrally formed with the housing body 12”. As shown, the fluid connector 22” includes an exterior projecting part 82” that projects from an exterior of the housing body 12” and an interior projecting part 84” which projects from the housing body 12” within the housing 11”. The interior projecting part 84” has a first couplable end 86’”, which is configured to be coupled to the manifold 37” and the exterior projecting part 82” comprises a second couplable end 88”, which is configured to be coupled to a tube set (not shown). The diameter of the first couplable end 86’ ’ is greater than the second couplable end 88’ ’, and the length of the interior projecting part 84” is greater than the exterior projecting part 82”. In this embodiment, the interior projecting part 84” and exterior projecting part 82” are substantially cylindrical and share a common axis.

[0206] In this embodiment, the exterior projecting part 82” includes a circumferential rib 87” spaced from where the exterior projecting part projects from the housing body and the second couplable end 88”. The circumferential rib 87” tapers inwardly in a radial direction to a point at a free end thereof.

[0207] As shown, a push fit connection connects the manifold 37” and the fluid connector 22”, and in particular this is formed by the housing opening of the manifold 37” being fitted over the41 170534979vlfirst couplable end 86”. The fact that the manifold is formed from resiliently deformable TPU facilitates the formation of this push fit connection. The common axis of the interior projecting part 84” and exterior projecting part 82” are co-axial with each of the housing opening axis and pump opening axis.

[0208] Referring now to Fig. 22, there is shown a part of a pump assembly 10”’ according to a fourth embodiment of the present invention. This embodiment is substantially the same as the third embodiment apart from the way the check valve 42’ ’ ’ and pressure relief valve 44’” are arranged. Like in the previously described embodiments, the manifold 37’” includes a check valve 42’” configured to maintain a one-way flow of air between the pump and the dressing and thus facilitate the formation of negative pressure within the wound dressing in use. Also, like in previous embodiments, the manifold 37’” includes a pressure relief valve. However, in this embodiment, the pressure relief valve 44’” is located fluidly between the check valve 42’” and the pump 16’” and is configured to open, if a negative pressure limit threshold between the pump and check valve is reached. The limit threshold prevents the pump from generating excessive levels of negative pressure at the wound bed. The pressure relief valve may be a coil spring and plunger assembly comprising a cracking pressure threshold in a range of between about -2.0 to -4 PSI, or between about -100 to -205 mmHg.

[0209] As shown, the manifold 37’” comprises a main hollow portion 49’” comprising the check valve 42’”, which in use is positioned between the pump 16’” and the dressing when the pump assembly provides negative pressure to the wound dressing. A hollow branch 51’” branches off the main hollow portion between the check valve 42’ ’ ’ and the pump 16”’, and the pressure relief valve 44’” is provided at a free end of the hollow branch 51’”. Specifically, the hollow branch 51’” comprises a head 53 ” ’ which comprises the pressure relief valve and the hollow branch 51’” extends from where it meets the main hollow portion 49’” to the head 53’”. The specific arrangement of the pressure relief valve 44’” of this embodiment provides greater robustness against manufacturing tolerances.

[0210] In use of the pump assembly 10’ of the second embodiment of the present invention, a tube set connected to a negative pressure wound dressing is connected to the fluid connector 22’. The user then presses the operational button 38’ to start the pump 16’ and negative pressure is then supplied to the wound dressing. If during the operation of the pump, the pump is not operating42 170534979vlcorrectly or the batteries are drained, this may be indicated by the LEDs 64 adjacent the marks 66’, 68’ and 70’ lighting up.

[0211] The pump assembly 10” of the third embodiment of the present invention is used in a similar way to the pump assembly 10’. If during the use of the pump assembly, the assembly is knocked or dropped, the hollow connector 41 ” can absorb loads supplied to the manifold 37’ ’ via the pressure sensor 72”. This means that the manifold is less likely to migrate out of an intended position and more likely to continue to operate as intended with all openings of the manifold remaining engaged with their respective engagement surfaces within the housing of the pump assembly 10”.

[0212] The pump assembly 10”’ of the fourth embodiment of the present invention is used in a similar way to the pump assembly 10’. If a- negative pressure limit threshold between the pump 16’” and check valve 42’” is reached, the pressure relief valve 44’” opens to relieve pressure. The pressure relief valve opening at the negative pressure limit threshold prevents the pump from generating excessive levels of negative pressure at the wound bed, such as a maximum negative pressure level associated with a clinically defined outer limit of beneficial treatment.

[0213] In a method of manufacture of the pump assembly 10’ of the second embodiment, as a first step the housing 11’ is formed. In particular, the housing body 12’ and top cover 14’ are molded. When doing this the fluid connector 22’ and housing body 12’ are molded integrally from plastic. The operational button 38’ and cover gasket 42’ are then integrally molded from the elastomeric material and overmolded to the top cover 14’. The battery gasket 44’ is then overmolded to the housing body. The pump 16’ is then positioned within the housing with the manifold which is then fluidly connected to the fluid connector 22’ and pump 16’. The PCBA 18’ is then positioned over the manifold and the pressure sensor 72’ fitted into the manifold. The top cover 14’ is then removably coupled to the housing body 12’ to seal the sealed interior.

[0214] In a method of manufacture of the pump assembly 10” of the third embodiment, as a first step the housing body 12” and top cover 14” are formed by a molding operation. Then the manifold is formed (also by molding). The manifold 37” is then coupled to the housing body by fitting the manifold 37” over the fluid connector 22”. The pump 16” is then fluidly coupled to the manifold within the housing body 12”. The PCBA 18” comprising the pressure sensor 72” is positioned above the manifold 37”. The pressure sensor 72” is then fitted into the hollow connector 41’ ’ so that a push fit connection between the pressure sensor 72’ ’ and hollow connector43 170534979vl41” is formed. The top cover 14” is then coupled to the housing body 12” to form the pump assembly of the third embodiment.

[0215] While embodiments incorporating the principles of the present disclosure have been described hereinabove, the present disclosure is not limited to the described embodiments. Instead, this application is intended to cover any variations, uses, or adaptations of the disclosure using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this disclosure pertains and which fall within the limits of the appended claims and / or the clauses below, which set out certain definitions of the invention.44 170534979vlClauses1. A pump assembly for providing a negative pressure to a wound dressing, comprising: a housing;a pump coupled to the housing and powered by a motor;a microprocessor configured to selectively power the motor; anda manifold fluidly coupled to the pump and fluidly coupling the pump with a connector formed in the housing.2. The pump assembly of clause 1 , wherein the connector is configured to fluidly couple the pump to a tube set.3. The pump assembly of clause 1, wherein the manifold comprises a check valve.4. The pump assembly of clause 3, wherein the manifold comprises a pressure sensor.5. The pump assembly of clause 3, wherein the manifold comprises a pressure relief valve.6. The pump assembly of clause 1 , wherein the manifold comprises a pressure relief valve interface configured to be fluidly coupled to a pressure relief valve.7. The pump assembly of clause 1 , wherein the manifold comprises a housing interface configured to space the manifold from a housing surface such that the manifold is aligned with the connector and pump.45 170534979vl8. The pump assembly of clause 1, wherein the manifold comprises a pressure sensor interface configured to be fluidly coupled to a pressure sensor.9. The pump assembly of clause 1 , wherein the manifold comprises a check valve interface configured to house a check valve.10. The pump assembly of clause 1, wherein the manifold comprises a vacuum pump interface configured to be fluidly coupled to the pump.11. The pump assembly of clause 1, wherein the manifold comprises a projection that corresponds with a cutout in the housing and configured to align the manifold with the housing.12. The pump assembly of clause 1, wherein the manifold comprises a check valve, a pressure relief valve, and a pressure sensor.13. The pump assembly of clause 1, comprising an indicator configured to be selectively illuminated.14. The pump assembly of clause 13, wherein the indicator is positioned within a sealed interior of the housing and illuminates an indicator section visible from a surrounding environment outside of the sealed interior.15. The pump assembly of clause 14, wherein the indicator provides a confirming indication when the pump assembly is functioning properly.46 170534979vl16. The pump assembly of clause 15, wherein the indicator provides a battery status indication identifying a status of the battery.17. The pump assembly of clause 1, wherein the pump is a diaphragm pump.18. The pump assembly of clause 4, wherein the pressure sensor is a pressure transducer configured to provide feedback to the microprocessor to selectively power the motor and pump to a specific pressure.19. The pump assembly of clause 5, wherein the pressure relief valve is a mechanical pressure relief valve fluidly coupled to the pump and configured to selectively prevent extreme pressures from being generated by the pump.20. A pump assembly for providing a negative pressure to a wound dressing, comprising: a housing comprising a top cover removably coupled to a housing body, the housing defining a sealed interior;a pump coupled to the housing body and powered by a motor;a microprocessor configured to selectively power the motor; andan operational button integrated into a top cover of the housing such that the interface between the operational button and the top cover provides a fluid-tight transition from the surrounding environment to the sealed interior around the operational button.21. The pump assembly of clause 20, wherein the operational button is overmolded to the cover.47 170534979vl22. The pump assembly of clause 20, further comprising a belt clip configured to be removably coupled to the housing.23. The pump assembly of clause 20, further comprising a tube set configured to fluidly couple a wound dressing to the pump.24. The pump assembly of clause 20, wherein the operational button is formed through an overmolding process with the top cover.25. The pump assembly of clause 24, wherein the top cover has a cover gasket formed through an overmolding process with the top cover.26. The pump assembly of clause 25, wherein the housing body has a body gasket formed through an overmolding process with the housing body and configured to be aligned with the gasket of the top cover.27. The pump assembly of clause 26, wherein the housing body defines a battery compartment having a battery gasket formed through an overmolding process with the housing body around the battery compartment.28. The pump assembly of clause 27, wherein the cover gasket, body gasket, and battery gasket are formed of Santoprene.48 170534979vl29. The pump assembly of clause 20, wherein the microprocessor and motor are positioned within the sealed interior.30. The pump assembly of clause 20, wherein the housing is formed of PC / ABS.31. The pump assembly of clause 20, wherein the housing comprises the top cover, the housing body, and a battery cover coupled to one another to define the sealed interior.32. The pump assembly of clause 1, wherein the manifold is formed from Santoprene.33. The pump assembly of clause 1, wherein the microprocessor is coupled to a printed circuit board assembly having four layers and configured to mitigate electromagnetic interference.34. The pump assembly of clause 1, comprising a foam wrapping around at least a portion of the pump, the foam wrapping configured to reduce noise and vibration of the pump.35. The pump assembly of clause 34, comprising a foam wrapping around at least a portion of the motor, the foam wrapping configured to reduce noise and vibration of the motor.36. The pump assembly of clause 2, wherein the tube set is coupleable to a wound dressing through a Swabbable Luer that fluidly isolates the wound dressing from the surrounding environment when the tube set is disconnected therefrom.49 170534979vl37. A method for controlling the pressure provided to a dressing in a negative pressure wound therapy system, comprising:monitoring an applied pressure provided to the dressing;establishing a desired pressure range at the dressing through an establishment phase implemented with a microcontroller, wherein the microcontroller selectively powers a pump assembly to provide negative pressure to the dressing during the establishment phase;executing a pressure maintenance phase with the microcontroller when the applied pressure is within the desired pressure range; andproviding an indication when the pressure maintenance phase is outside of maintenance phase parameters.38. The method of clause 37, wherein prior to executing the establishment phase, the microcontroller ensures a current battery voltage exceeds a minimum voltage threshold.39. The method of clause 37, wherein prior to executing the establishment phase, the microcontroller ensures the microcontroller has not been operating for greater than a time threshold.40. The method of clause 37, wherein prior to, or during, the establishment phase, the microcontroller determines whether a leak is detected.41. The method of clause 37, wherein prior to executing the establishment phase, the microcontroller ensures a current battery voltage exceeds a minimum voltage threshold and that the microcontroller has not been operating for greater than a time threshold.42. The method of clause 41, wherein the time threshold is 15 days.50 170534979vl43. The method of clause 41, wherein the time threshold is 30 days.44. The method of clause 37, wherein the method is initiated when the microcontroller is powered and receives an input from a button.45. The method of clause 37, wherein the method is paused when the microcontroller receives a pause input signal from a button.46. The method of clause 37, wherein the microcontroller selectively provides an indication when a leak is detected.47. The method of clause 37, wherein the microcontroller selectively provides an indication when a battery voltage is less than a voltage threshold.48. The method of clause 37, wherein the microcontroller pauses the pump assembly when a leak is detected.49. The method of clause 37, comprising executing a self-test when the microcontroller is powered to ensure operating parameters are acceptable prior to commencing a therapy.50. The method of clause 37, wherein during the pressure maintenance phase the microcontroller monitors the applied pressure to ensure the applied pressure remains in the desired pressure range.51 170534979vl51. The method of clause 37, wherein a user interaction or a leak will move the device out of the pressure maintenance phase.52. The method of clause 37, wherein the microcontroller will not power the pump assembly if the system has been in use for greater than a time threshold.53. The method of clause 37, wherein the microcontroller will enter a fault state if a fault is identified during the establishment phase, wherein the fault state disables use of the system.54. The method of clause 37, wherein the microcontroller flashes an indicator in a first form when the system is powered and operating normally.55. The method of clause 54, wherein the microcontroller flashes the indicator in a second form that is different from the first form when the microcontroller identifies a leak.56. The method of clause 37, wherein the microcontroller flashes the indicator in a low battery form when the provided power drops below a power threshold.57. The method of clause 37, wherein the microcontroller selectively powers the pump assembly with a pulse width modulated signal, wherein the pulse width modulated signal is selected to operate the pump assembly in a quiet state and to minimize power consumption of the pump assembly.58. The method of clause 57, wherein the pulse width modulated signal is proved to a Field Effect Transistor for a motor of the pump assembly.52 170534979vl59. The method of clause 37, wherein the microcontroller selectively wirelessly communicates data from the system to an external device.60. The method of clause 37, wherein when the microcontroller detects a system fault the microcontroller enters a fault state wherein the microcontroller logs an error condition that caused the system fault.61. The method of clause 37, wherein the microcontroller has a brown-out detection protocol that allows the microcontroller to detect a power failure and shutdown through a cooldown procedure.62. The method of clause 37, wherein the microcontroller selectively powers two pump assembly control field-effect transistors to power the pump assembly.63. The method of clause 62, wherein both of the two pump assembly control field-effect transistors must be powered for the pump assembly to operate.64. The method of clause 63, wherein The vacuum pump drive signal is pulse width modulated and fed back into the MCU to confirm the pump is being driven as expected.65. The pump assembly of clause 27, wherein the battery compartment houses a serial communication port that is configured to provide a wired connection for diagnostics.66. The method of clause 60, wherein the error log is configured to be downloaded.53 170534979vl67. The pump assembly of clause 20, wherein the operational button comprises a tactile switch configured to provide one or both of a haptic feedback or an audible click when the operational button has been pressed correctly.68. A method of manufacturing a pump assembly for providing a negative pressure to a wound dressing, comprising:assembling a housing containing a pump selectively powered by a motor; connecting a microprocessor to the motor to selectively power the pump;coupling a manifold to the pump to direct negative pressure generated by the pump to a connector;coupling a pressure sensor to the manifold and electrically coupling the pressure sensor to the microprocessor to communicate a value representative of the pressure in the manifold to the microprocessor;executing a calibration step comprising operating the pump assembly while the connector is coupled to an external pressure sensor;loading calibrated software generated in part during the calibration step to be executed by the microprocessor.69. The method of clause 68, further wherein the calibration step comprises connecting the connector to a leak tester to determine a leak test calibration as part of the calibrated software.70. The method of clause 68, comprising initially providing access to manufacturing test software to the microprocessor before the calibration step is completed, and at least partially updating the manufacturing test software with the calibrated software upon completion of the calibration step.54 170534979vl71. The method of clause 68, comprising connecting the external pressure sensor to the microprocessor through a serial communication port.72. The method of clause 71, wherein the serial communication port is located in a battery compartment of the pump assembly.73. The method of clause 68, further comprising packaging the pump assembly in a sealed box or bag after the calibrated software is loaded.74. The method of clause 68, comprising initially providing access to manufacturing test software to the microprocessor before the calibration step is completed, and establishing verified product software after the calibration step is completed.75. The method of clause 74, further comprising locking and replacing the manufacturing test software with the verified product software.55 170534979vl

Claims

Claims1. A pump assembly for providing a negative pressure to a wound dressing, comprising:a housing;a pump; anda manifold fluidly coupled to the pump and fluidly coupling the pump with a connector formed in the housing.

2. The pump assembly of claim 1 , wherein the pump is coupled to the housing, wherein the pump is powered by a motor, wherein the pump assembly further comprises a microprocessor configured to selectively power the motor.

3. The pump assembly of claim 1 or 2, wherein the connector is formed in material of the housing.

4. The pump assembly of any preceding claim, wherein the housing and connector are integrally formed.

5. The pump assembly of any preceding claim, wherein the housing and connector are seamlessly connected.

6. The pump assembly of any preceding claim, wherein the housing comprises a housing body and the connector, wherein the connector extends from the housing body, wherein the connector and housing body are integrally formed.

7. The pump assembly of any preceding claim, wherein the connector includes an exterior projecting part that projects from an exterior of the housing; and an interior projecting part which projects from the housing body within the housing.

8. A pump assembly for providing a negative pressure to a wound dressing, comprising:a housing comprising a top cover removably coupled to a housing body, the housing defining a sealed interior;a pump; and56 170534979vlan operational button integrated into a top cover of the housing such that the interface between the operational button and the top cover provides a fluid-tight transition from the surrounding environment to the sealed interior around the operational button.

9. The pump assembly of claim 8, wherein the pump is coupled to the housing body, wherein the pump is powered by a motor, wherein the assembly comprises a microprocessor configured to selectively power the motor.

10. The pump assembly of claim 8 or 9, wherein the operational button is formed through an overmolding process with the top cover.

11. The pump assembly of any of claims 8 to 10, wherein the top cover has a cover gasket, wherein the cover gasket is formed through an overmolding process.

12. The pump assembly of claim 11, wherein the cover gasket is formed through an overmolding process with the top cover.

13. The pump assembly of claim 11 or 12, wherein the cover gasket forms a loop that extends parallel to a perimeter of the top cover.

14. The pump assembly of any of claims 8 to 13, wherein the operational button and cover gasket are integrally formed.

15. The pump assembly of any of claims 8 to 14, wherein the housing is curved.

16. The pump assembly of any of claims 8 to 15, wherein the top cover comprises a plurality of ribs, wherein the plurality of ribs are located on an inner surface of the top cover.

17. A pump assembly for providing negative pressure to a wound dressing, comprising:a housing;a pump;a manifold fluidly coupled to the pump within the housing, the manifold having:a manifold body, anda connector flexibly attached to the manifold body; and57 170534979vla sensor fitted into the connector.

18. The pump assembly of claim 17, wherein an outer surface of the manifold comprises a depression, wherein the connector is located within the depression.

19. The pump assembly of claim 17 or 18, wherein the connector is connected to the manifold body by a flexible joint.

20. The pump assembly of any of claims 17 to 19, wherein the pump assembly comprises a printed circuit board assembly (PCBA), wherein the PCBA comprises the sensor and a circuit board, wherein the sensor extends from the circuit board into the connector.

21. The pump assembly of claim 20, wherein the sensor is a pressure sensor.

22. The pump assembly of any of claims 17 to 21, wherein the connector and manifold body are integrally formed.

23. The pump assembly of any of claims 17 to 22, wherein the sensor is received in the open-ended passage, wherein the open-ended passage is resiliently deformable.

24. The pump assembly of any of claims 17 to 23, wherein the manifold comprises a check valve, wherein the check valve is positioned to be fluidly between the pump and the dressing when the pump assembly provides negative pressure to the wound dressing, wherein the manifold further comprises a pressure relief valve, wherein the pressure relief valve is located fluidly between the check valve and the pump.

25. The pump assembly of claim 24, wherein the manifold comprises a main hollow portion comprising the check valve, wherein the main hollow portion is positioned between the pump and the dressing when the pump assembly provides negative pressure to the wound dressing, wherein a hollow branch branches off the main hollow portion between the check valve and the pump, wherein the hollow branch comprises the pressure relief valve.58 170534979vl

Images