CN116981489A - Negative pressure wound treatment device - Google Patents

Negative pressure wound treatment device Download PDF

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Publication number
CN116981489A
CN116981489A CN202280016895.0A CN202280016895A CN116981489A CN 116981489 A CN116981489 A CN 116981489A CN 202280016895 A CN202280016895 A CN 202280016895A CN 116981489 A CN116981489 A CN 116981489A
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CN
China
Prior art keywords
canister
negative pressure
wound
noise reduction
reduction chamber
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN202280016895.0A
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Chinese (zh)
Inventor
本·艾伦·阿斯肯
W·戴维斯
D·M·埃德
J·C·格伦克罗斯
D·S·约翰逊
C·P·马德里兹
A·马焦雷
J·D·麦克卢斯基
克里斯托弗·约翰·韦伯
H·B·威登
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TJ Smith and Nephew Ltd
Original Assignee
TJ Smith and Nephew Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by TJ Smith and Nephew Ltd filed Critical TJ Smith and Nephew Ltd
Priority claimed from PCT/EP2022/057668 external-priority patent/WO2022200453A1/en
Publication of CN116981489A publication Critical patent/CN116981489A/en
Pending legal-status Critical Current

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Abstract

A negative pressure device has a negative pressure source, a canister in fluid communication with the negative pressure source, a conduit capable of coupling with a wound dressing to provide negative pressure to a space below the wound dressing. Some arrangements of the negative pressure source can have a first noise reduction chamber and a second noise reduction chamber downstream of the pump and in fluid communication with an outlet of the pump. The first and second noise reduction chambers can be configured to reduce noise generated by the pump and/or to reduce pressure pulse levels in fluid advancing through the negative pressure source.

Description

Negative pressure wound treatment device
Cross Reference to Related Applications
The present application claims priority from uk provisional application No. 2104021.7 filed 3/23/2021 and uk provisional application No. 2116401.7 filed 11/15/2021, each of which is incorporated herein by reference in its entirety as if fully set forth herein. The benefit of the priority is claimed in accordance with appropriate legal guidelines including, but not limited to, 35U.S. C. clause 119 (e).
Technical Field
The arrangements described herein relate to devices, systems, and methods for treating wounds, including, for example, devices, systems, and methods for a negative pressure source for use with a negative pressure wound therapy dressing.
Background
Many different types of wound dressings are known for aiding the healing process of humans or animals. These different types of wound dressings include many different types of materials and layers, such as gauze, pads, foam pads, or multi-layered wound dressings. Topical Negative Pressure (TNP) therapy, sometimes also referred to as vacuum assisted closure, negative pressure wound therapy or reduced pressure wound therapy, is widely recognized as a beneficial mechanism for improving the rate of healing of wounds. Such treatments are applicable to a wide range of wounds, such as incisional wounds, open wounds, abdominal wounds, and the like. TNP therapy helps to close and heal wounds by reducing tissue edema, promoting blood flow, stimulating the formation of granulation tissue, removing excess exudates, and may reduce bacterial load. Thus, wound infection is reduced. Furthermore, TNP therapy allows the wound to be less disturbed externally and promotes faster healing.
Disclosure of Invention
The systems, methods, and apparatus of the present disclosure each have several innovative aspects, embodiments, or aspects, with a single aspect not being solely responsible for the desirable attributes disclosed herein.
Disclosed herein are arrangements of negative pressure wound therapy systems that may include one or more of the following: a pump assembly comprising a negative pressure source configured to be fluidly connected to a wound covered by a wound dressing; a canister coupleable with the pump assembly and configured to collect fluid aspirated from a wound as a result of negative pressure provided to the wound by the negative pressure source; and a canister release mechanism coupled with the pump assembly and including an actuator coupled with one or more movable latches, the canister release mechanism configured to disengage the pump assembly from the canister. In some arrangements, the one or more latches may be configured to move between a first position in which the one or more latches secure the canister to the pump assembly and a second position in which the one or more latches release the canister from the pump assembly when the actuator is depressed.
In additional arrangements, any arrangement of negative pressure wound therapy devices, systems, and methods of using the negative pressure wound therapy devices and components of negative pressure wound therapy devices disclosed herein may include one or more of the following steps, features, components, and/or details in any combination with any other step, feature, component, and/or detail of any other arrangement disclosed herein: further comprising a cap coupleable with an opening on the canister; further comprising a filter positioned within or supported by the cap; wherein the cap comprises a shield configured to overlap at least a portion of the filter so as to inhibit exudate within the canister from splashing onto at least a portion of the filter, the shield overlapping at least 40% of a surface area of the first major surface of the filter; wherein the one or more latches are configured to engage a cap coupled to the canister in the first position and release the cap coupled to the canister in the second position; wherein the canister release mechanism is configured to release the canister from the pump assembly by depressing only a single button; wherein the single button is supported by an outer surface of a housing of the pump assembly; wherein the canister release mechanism is configured to release the canister from the pump assembly with only one-handed operation; wherein the canister release mechanism comprises a button, and wherein the actuator is configured to move the one or more latches from the first position to the second position when the button is pressed; wherein the button is supported by an outer surface of a housing of the device; wherein the canister release mechanism is configured to move the canister away from the pump assembly when the canister release mechanism is actuated; wherein the canister release mechanism includes at least one tab configured to push the canister away from the pump assembly when the canister release mechanism is actuated; wherein the pump assembly comprises a power cord electrically connected to a panel, the panel being removable from the exterior of the housing of the pump assembly without removing or opening the housing, such that a power outlet and/or the power cord can be replaced by replacing the panel removable from the exterior of the housing of the pump device; wherein the user interface of the pump assembly is located on an upper surface of the pump device, the upper surface being oriented at an angle within 35 ° of horizontal; and/or wherein the pump device has one or more conduit supports removably coupled with a housing of the pump device, wherein a conduit of the pump device extends through a closed opening of the one or more conduit supports, and the one or more conduit supports have at least one additional opening in which the conduit is removably supportable.
Also disclosed herein is an arrangement of a negative pressure wound therapy system, which may include one or more of: a device comprising a negative pressure pump actuated by a pump motor, a battery, a display, a lower core assembly, and an upper support within a housing; a canister coupleable with the device and configured to collect fluid aspirated from a wound covered by a wound dressing as a result of negative pressure provided by the negative pressure pump to the wound; and a cap coupled with the opening on the canister. In any of the arrangements disclosed herein, the lower core assembly may be configured to receive and support at least the pump motor and the battery. Further, in some arrangements, the upper support may be coupled with the lower core assembly, the upper support extending above the lower core assembly. Further, in some arrangements, the upper support may be configured to receive and support at least a display of a pump assembly, and the display may be removed from the pump assembly by removing the housing and by removing the upper support from the pump assembly.
In additional arrangements, any arrangement of the negative pressure wound therapy system, the method of using the negative pressure wound therapy system and components of the negative pressure wound therapy system disclosed herein may include one or more of the following steps, features, components, and/or details in any combination with any other step, feature, component, and/or detail of any other arrangement disclosed herein: further comprising a filter coupled to or supported by the cap; wherein the filter comprises a carbon filter; further comprising a hydrophobic filter coupled to or supported by the cap; wherein the cap comprises a shield configured to overlap at least a portion of the filter so as to inhibit exudate within the canister from splashing onto at least a portion of the filter, the shield overlapping at least 40%, or at least 80% or more of the surface area of the first major surface of the filter; further comprising a canister release mechanism; wherein the canister release mechanism comprises one or more latches configured to move between a first position in which the one or more latches secure the canister to the device and a second position in which the one or more latches release the canister from the device.
Disclosed herein are arrangements of negative pressure wound therapy devices. In some arrangements, the negative pressure wound therapy device may include a negative pressure source including an inlet and an outlet, the negative pressure source configured to provide negative pressure to a wound covered by a wound dressing via a fluid flow path to aspirate fluid from the wound; a first noise reduction chamber positionable in the fluid flow path downstream of the negative pressure source and in fluid communication with an outlet of the negative pressure source; and a second noise reduction chamber downstream of the negative pressure source and in fluid communication with an outlet of the first noise reduction chamber. The second noise reduction chamber may be different from the first noise reduction chamber. The first noise reduction chamber may have an inlet and an outlet and may be configured to reduce noise generated by the pump and/or to reduce pressure pulse levels in the fluid advancing through the pump. The second noise reduction chamber may have an inlet and an outlet and may be configured to reduce noise generated by the pump and/or to reduce pressure pulse levels in the fluid advancing through the pump and the first noise reduction chamber. The second noise reduction chamber may be spaced apart from the first noise reduction chamber.
Also disclosed herein is an arrangement of a negative pressure wound therapy device. In some arrangements, the negative pressure wound therapy device may include a negative pressure source including an inlet and an outlet, the negative pressure source configured to provide negative pressure to a wound covered by a wound dressing via a fluid flow path to aspirate fluid from the wound. The negative pressure wound therapy device may include a first noise reduction chamber that may be positioned in the fluid flow path downstream of the negative pressure source and in fluid communication with an outlet of the negative pressure source. The first noise reduction chamber may include an inlet and an outlet, and may be configured to reduce noise generated by aspiration of fluid from the wound. The negative pressure wound therapy device may further include a second noise reduction chamber positioned in the fluid flow path downstream of the negative pressure source and in fluid communication with an outlet of the first noise reduction chamber. The second noise reduction chamber may include an inlet and an outlet, and may be configured to reduce noise generated by aspiration of fluid from the wound. In some arrangements, the second noise reduction chamber may be spaced apart from the first noise reduction chamber and may be different from the first noise reduction chamber. Further, the second noise reduction chamber may be positioned in series with and downstream of the first noise reduction chamber. Additionally, in some arrangements, the second noise reduction chamber may be closer to an exhaust of the device than the first noise reduction chamber.
In additional arrangements, any arrangement of negative pressure wound therapy devices, systems, and methods of using the negative pressure wound therapy devices and components of negative pressure wound therapy devices disclosed herein may include one or more of the following steps, features, components, and/or details in any combination with any other step, feature, component, and/or detail of any other arrangement disclosed herein: wherein the negative pressure wound therapy device further comprises a foam positioned in at least one of the first noise reduction chamber and the second noise reduction chamber; wherein the first noise reduction chamber comprises an inner wall extending across a majority of a distance between a first wall of the first noise reduction chamber and a second wall adjacent or positioned opposite the first wall such that an opening is formed between an end of the inner wall and the second wall, the first noise reduction chamber configured to create a passageway between an inlet and an outlet of the first noise reduction chamber requiring the fluid passing through the first noise reduction chamber to pass through the opening formed between the end of an inner wall segment and the second wall; wherein the internal volume in the first noise reduction chamber and the second noise reduction chamber is greater than the volume within a first conduit in fluid communication with the inlet of at least one of the first noise reduction chamber or the second noise reduction chamber and greater than the volume within a second conduit in fluid communication with the outlet of at least one of the first noise reduction chamber or the second noise reduction chamber; further comprising a flow module comprising one or more pressure sensors; further comprising a flow manifold comprising one or more pressure sensors; further comprising a check valve positioned in the fluid flow path and configured to prevent fluid from flowing back in a reverse direction toward the negative pressure source; wherein the first noise reduction chamber is positioned upstream of the check valve and the second noise reduction chamber is positioned downstream of the check valve; wherein the negative pressure source comprises an electric motor, and wherein the apparatus further comprises a power source configured to power the electric motor; comprising a canister couplable with the device and configured to collect fluid aspirated from the wound as a result of negative pressure provided to the wound by the negative pressure source; and a cap coupled with an opening on the canister; further comprising a filter coupled to or supported by the cap; wherein the filter comprises a carbon filter; and/or further comprising a hydrophobic filter coupled to or supported by the cap.
In some arrangements, a negative pressure wound therapy device may include a device housing and a negative pressure source supported by the device housing and configured to provide negative pressure to a wound covered by a wound dressing. The device may include a canister configured to be in fluid communication with the negative pressure source and the wound dressing. The canister may include a canister housing configured to store fluid aspirated from the wound. The canister may include a cap connected to the canister housing and configured to be connected to the device housing when the canister is removably attached to the device housing. The canister may include a fluid level sensor supported by the cap, the fluid level sensor including an electrode positioned on a support extending into the interior of the canister housing, the electrode configured to be in fluid communication with fluid aspirated from the wound. The support may include a flange configured to inhibit fluid from splashing onto the electrode positioned on the support. The fluid level sensor may be configured to detect a completed electrical circuit when fluid aspirated from the wound contacts the electrode. The level sensor may be configured to detect a tank full condition when the circuit is completed. The canister may include electronic circuitry configured to communicate (e.g., wirelessly) a status of the canister detected by the level sensor.
Also disclosed is an arrangement of a method of operating the arrangement of the device of any preceding paragraph and/or an arrangement of any system or device disclosed herein, a kit comprising the device of any preceding claim and a wound dressing.
Any feature, component, or detail of any arrangement or arrangement disclosed in the present application, including but not limited to any device arrangement and any negative pressure wound therapy arrangement disclosed herein, may be interchangeably combined with any other feature, component, or detail of any arrangement or arrangement disclosed herein to form new arrangements and arrangements.
Drawings
Fig. 1A shows a negative pressure wound therapy system.
Fig. 1B illustrates another negative pressure wound therapy system.
Fig. 2A is an isometric view of a negative pressure wound therapy device having a pump assembly and canister.
Fig. 2B is a front view of the negative pressure wound therapy device shown in fig. 2A.
Fig. 2C is a rear view of the negative pressure wound therapy device shown in fig. 2A.
Fig. 2D is a side view of the negative pressure wound therapy device shown in fig. 2A.
Fig. 2E is an isometric view of the back and bottom of the negative pressure wound therapy device shown in fig. 2A.
Fig. 2F is a top view of the negative pressure wound therapy device shown in fig. 2A.
Fig. 2G is a cross-sectional view of the negative pressure wound therapy device shown in fig. 2A, taken through line 2G-2G in fig. 2F.
Fig. 2H is an isometric view of the negative pressure wound therapy device shown in fig. 2A, showing the canister separated from the pump assembly.
Fig. 2I illustrates a top surface of the negative pressure wound therapy device shown in fig. 2A, showing a user interface.
Fig. 3A shows an exploded view of the pump assembly of the negative pressure wound therapy device shown in fig. 2A.
Fig. 3B shows a canister of the negative pressure wound therapy device shown in fig. 2A.
Fig. 3C-3F illustrate partially exploded views of portions of the pump assembly shown in fig. 3A.
Figures 3G-3K illustrate portions of another arrangement of a pump assembly.
Fig. 4A-4H illustrate a lower core assembly of the pump assembly shown in fig. 3A.
Fig. 5A-5E illustrate the cap assembly of the can shown in fig. 3B.
Fig. 6A-6F illustrate variations of filters that may be used with any of the negative pressure wound therapy devices disclosed herein.
Fig. 7A illustrates a tubing support of the negative pressure wound therapy device shown in fig. 2A.
Fig. 7B illustrates a portion of the pump assembly shown in fig. 2A.
Figures 8A-8D illustrate variations of handles that may be used with any of the negative pressure wound therapy devices disclosed herein.
Fig. 9 shows a schematic of a control system of a negative pressure wound therapy device.
Fig. 10 illustrates another negative pressure wound therapy system.
11A-11D illustrate arrangements of tank assemblies that may be used with any of the pump assembly arrangements disclosed herein.
Fig. 12A-12D illustrate another arrangement of tank assemblies that may be used with any of the pump assembly arrangements disclosed herein.
Fig. 13A-13B illustrate another arrangement of tank assemblies that may be used with any of the pump assembly arrangements disclosed herein.
Fig. 14A-14D illustrate another arrangement of tank assemblies that may be used with any of the pump assembly arrangements disclosed herein.
Fig. 15A is a top, front and left perspective view of an arrangement of a device for applying negative pressure to a wound.
Fig. 15B is a front view of the arrangement of the device of fig. 15A.
Fig. 15C is a rear view of the arrangement of the device of fig. 15A.
Fig. 15D is a right side view of the arrangement of the device of fig. 15A.
Fig. 15E is a left side view of the arrangement of the device of fig. 15A.
Fig. 15F is a top view of the arrangement of the device of fig. 15A.
Fig. 15G is a bottom view of the arrangement of the device of fig. 15A.
Fig. 16A is a top, front and left perspective view of another arrangement of a device for applying negative pressure to a wound.
Fig. 16B is a front view of the arrangement of the device of fig. 16A.
Fig. 16C is a rear view of the arrangement of the device of fig. 16A.
Fig. 16D is a right side view of the arrangement of the device of fig. 16A.
Fig. 16E is a left side view of the arrangement of the device of fig. 16A.
Fig. 16F is a top view of the arrangement of the device of fig. 16A.
Fig. 16G is a bottom view of the arrangement of the device of fig. 16A.
Fig. 17A is a top, front and left perspective view of another arrangement of a device for applying negative pressure to a wound.
Fig. 17B is a front view of the arrangement of the device of fig. 17A.
Fig. 17C is a rear view of the arrangement of the device of fig. 17A.
Fig. 17D is a right side view of the arrangement of the device of fig. 17A.
Fig. 17E is a left side view of the arrangement of the device of fig. 17A.
Fig. 17F is a top view of the arrangement of the device of fig. 17A.
Fig. 17G is a bottom view of the arrangement of the device of fig. 17A.
Fig. 18A is a top, front and left perspective view of another arrangement of a device for applying negative pressure to a wound.
Fig. 18B is a front view of the arrangement of the device of fig. 18A.
Fig. 18C is a rear view of the arrangement of the device of fig. 18A.
Fig. 18D is a right side view of the arrangement of the device of fig. 18A.
Fig. 18E is a left side view of the arrangement of the device of fig. 18A.
Fig. 18F is a top view of the arrangement of the device of fig. 18A.
Fig. 18G is a bottom view of the arrangement of the device of fig. 18A.
Detailed Description
The arrangements disclosed herein relate to systems and methods for treating and/or monitoring wounds. Some arrangements of the negative pressure wound treatment devices disclosed herein may include a negative pressure source configured to connect and/or fluidly couple to a wound covered by the wound dressing via a fluid flow path and provide negative pressure to the wound.
Throughout this specification, reference is made to wounds. The term wound should be construed broadly and encompasses open and closed wounds in which the skin is torn, cut or punctured, or in which the wound causes a bruise or any other superficial or other condition or defect in the skin of the patient, or other wounds that benefit from pressure therapy. Thus, a wound is broadly defined as any damaged tissue area that may or may not produce fluid. Examples of such wounds include, but are not limited to, abdominal wounds or other large or incised wounds, abdominal wounds with open viscera, abdominal compartment syndrome, burns, partial thickness burns, either due to surgery, trauma, sternotomy, fasciotomy, or due to other conditions, dehiscence wounds, acute wounds, subacute wounds, chronic wounds, subacute and dehiscence wounds, traumatic wounds, flaps and skin grafts, lacerations, abrasions, contusions, burns, diabetic ulcers, pressure ulcers, stomas, surgical wounds, traumatic ulcers, venous ulcers, and the like.
The arrangement of the systems and methods disclosed herein may be used with a topical negative pressure ("TNP") or reduced pressure treatment system. In short, negative pressure wound therapy helps to close and heal many forms of "hard to heal" wounds by reducing tissue edema, promoting blood flow and granulation tissue formation, or removing excess exudates, and can reduce bacterial load (and thus reduce risk of infection). In addition, the treatment allows the wound to be less disturbed, thereby healing more rapidly. The TNP therapy system may also assist in surgically closed wound healing by removing fluids. TNP therapy may help stabilize tissue at the apposed closed position. Another beneficial use of TNP therapy can be found in grafts and flaps, in which case removal of excess fluid is important and it is necessary to bring the graft in close proximity to the tissue in order to ensure tissue viability.
As used herein, reduced pressure level or negative pressure level (e.g., -xhhg) refers to a pressure level relative to normal ambient atmospheric pressure, which may correspond to 760mmHg (or 1atm, 29.93inHg, 101.325kPa, 14.696psi, etc.). Thus, the negative pressure value of-XmmHg reflects a pressure that is lower by XmmHg than 760mmHg, or in other words, (760-X) mmHg. In addition, a negative pressure that is "less" or "smaller" than XmmHg corresponds to a pressure that is closer to atmospheric pressure (e.g., -40mmHg is less than-60 mmHg). The negative pressure "more" or "greater" than-XmmHg corresponds to a pressure farther from the atmospheric pressure (e.g., -80mmHg than-60 mmHg). In some cases, the local ambient atmospheric pressure is used as a reference point, which may not necessarily be, for example, 760mmHg.
The systems and methods disclosed herein may be used with other types of treatment in addition to or instead of reduced pressure treatment, such as perfusion, removal of perfusion fluid, ultrasound, heating or cooling, nerve stimulation, and the like. In some cases, the disclosed systems and methods may be used for wound monitoring without the application of additional therapy. The systems and methods disclosed herein may be used in conjunction with dressings including compression dressings, reduced pressure dressings, and the like.
A healthcare provider, such as a clinician, nurse, etc., may provide a TNP prescription specifying, for example, a pressure level or administration time. However, the healing process is different for each patient, and the prescription may affect the healing process in ways that are not desirable for the clinician or healthcare provider in designing the prescription. Healthcare providers may attempt to adjust prescriptions as a wound heals (or does not heal), but such procedures may require various appointments that may be time consuming and repetitive. The arrangement disclosed herein provides a system, device or method that effectively adjusts a TNP prescription and delivers effective TNP therapy.
Wound treatment system
Any embodiment of a negative pressure wound therapy device or system disclosed herein may have a pump assembly (also referred to herein as a device or pump device) having a core assembly. Some arrangements of the core assembly may include all or nearly all of the electrical and mechanical components and features required for user interface, negative pressure control, and battery operation. The core component may include a Printed Circuit Board Assembly (PCBA), which may be an electronic component that may include two system microcontrollers. The PCBA may include a master controller that may control the operation of one or more of the user interface, the communication interface, and the alert generation. The PCBA may include a motor controller (sometimes referred to as a pump controller) that may control operation of the pump or monitor one or more of other signals (such as temperature, pump voltage/current, etc.). Any of the embodiments of the system disclosed herein may have two microcontrollers to provide some redundancy to the system. In this arrangement, if one controller fails, the other controller can respond and ensure system fail-safe. The two microcontrollers may share conventional communications to check if the other microcontroller is still operating. In any arrangement, the core component may include a display, which may be one or more of a color display or a touch screen.
Any embodiment of the core assembly may include a flow module (or flow manifold). In some arrangements, the flow module may include a two-part housing that forms an internal path when assembled. The flow module may be configured to allow tank connections, pressure sensors, self-test solenoids, and check valves to be integrally formed with minimal external piping. This reduces the chance of any internal piping getting stuck or kinked. The flow module may have one or two or more pressure sensors. The flow module may have two pressure sensors, one on each side of the solenoid of the flow module. The pressure sensor may allow for measuring the air flow by measuring the pressure drop across the solenoid. The check valve may be used to prevent any rewet due to motor valve wear.
In some arrangements, a plastic molding is used for the core module or core assembly structure. Each module within the pump assembly may be supported by a separate plastic molding such that each module may be fully supported on the separate plastic molding.
The negative pressure wound therapy system 100 may have a canister locking mechanism between the pump assembly 160 and the canister 162. In some arrangements, the locking mechanism may have a spring mechanism that may be selectively engaged or secured to a can cap that may be threadably or otherwise coupled (e.g., welded, glued, etc.) with the can. The canister release button may be used to unlock the locking mechanism and allow removal of the canister. Some arrangements of the canister locking/unlocking mechanism may be configured to operate with a single hand to facilitate removal of the canister from the pump assembly by a user who may have only one hand or many users who have only one powerful hand. For example, but not limited to, the canister locking mechanism may be unlocked such that the canister may be removed from the pump assembly by depressing the canister release button. The negative pressure wound therapy system 100 may be configured to unlock the canister locking mechanism and, in some arrangements, cause the pump assembly to exert a force on the canister to physically separate the canister from the pump assembly. In other arrangements, the negative pressure wound therapy system 100 may be configured to enable a user to remove the canister from the pump assembly using only one hand (i.e., in a single-handed operation). Further, some arrangements of the negative pressure wound therapy system 100 may be configured such that the canister may be relatively easily separated from the pump assembly by pressing the canister release button with one hand or finger. In some arrangements, the use of this locking mechanism, while making the pump unit somewhat more complex, is beneficial because the locking mechanism allows for a simpler canister design (without a separate clip) and gives a good user experience. The lower core assembly or support may provide support for the battery, pump and flow module. The upper core component may support the PCBA and the display.
Fig. 1A schematically illustrates a negative pressure wound therapy system 100 (sometimes referred to as a reduced or negative pressure wound therapy system, TNP system, or wound therapy system). In any of the embodiments disclosed herein, although not required, the negative pressure wound therapy system 100 may include a wound filler 102 placed on or within a wound 104 (which may be a cavity). The wound 104 may be sealed by a wound cover 106 (which may be a drape) such that the wound cover 106 may be in fluid communication with the wound 104. The combination of wound filler 102 and wound cover 106 may be referred to as a wound dressing. A tube or conduit 108 (also referred to herein as a flexible suction adapter or fluid connector) may be used to connect the wound cover 106 with a wound treatment device 110 (sometimes referred to in whole or in part as a "pump assembly") configured to supply reduced pressure or negative pressure. The catheter 108 may be a single lumen tube or a multi-lumen tube. The connector 112 may be used to removably and selectively couple the conduit or tube 142 with the conduit 108.
In any of the systems disclosed herein, the wound treatment apparatus may be canister-free, with wound exudate collected in a wound dressing or transferred via a catheter for collection at another location, for example, but not limited to. However, any wound treatment apparatus disclosed herein may include or support a canister.
Additionally, for any of the wound treatment systems disclosed herein, any wound treatment apparatus may be mounted to or supported by or adjacent to a wound dressing. The wound filler 102 may be of any suitable type, such as hydrophilic or hydrophobic foam, gauze, inflatable pouch, and the like. The wound filler 102 may conform to the wound 104 such that the wound filler 102 substantially fills the cavity of the wound 104. Wound cover 106 may provide a substantially fluid-impermeable seal over wound 104. Wound cover 106 may have a top side and a bottom side. The bottom side may be sealed to the wound 104 (or in any other suitable manner), such as by sealing with the skin surrounding the wound 104. The conduit 108, or any other conduit disclosed herein, may be formed of polyurethane, PVC, nylon, polyethylene, silicone, or any other suitable material.
Wound cover 106 may have a port (not shown) configured to receive an end of catheter 108. In some cases, the conduit 108 may otherwise pass through or under the wound cover 106 to supply reduced pressure to the wound 104 in order to maintain a desired reduced pressure level in the wound 104. The conduit 108 may be any suitable article configured to provide an at least substantially sealed fluid flow path or path between the wound treatment device 110 and the wound cover 106 in order to supply the reduced pressure provided by the wound treatment device 110 to the wound 104.
The wound cover 106 and the wound filler 102 may be provided as a single article or as an integral single unit. In some cases, no wound filler is provided, and the wound cover itself may be considered a wound dressing. The wound dressing may then be connected to a negative pressure source of the wound treatment apparatus 110 via the conduit 108. In some cases, although not required, the wound treatment apparatus 110 may be miniaturized and portable, but larger conventional negative pressure sources (or pumps) may also be used.
Wound cover 106 may be positioned over a wound site to be treated. Wound cover 106 may form a substantially sealed cavity or enclosure over the wound. The wound cover 106 may have a membrane with high water vapor permeability to enable evaporation of residual fluids and may have superabsorbent material contained therein to safely absorb wound exudate. In some cases, the components of the TNP systems described herein may be particularly suitable for incised wounds that exude small amounts of wound exudate.
The wound treatment apparatus 110 may be operated with or without an exudate canister. In some cases, as shown, the wound treatment apparatus 110 may include an exudate canister. In some cases, the wound treatment apparatus 110 and the catheter 108 are configured such that the catheter 108 can be quickly and easily removed from the wound treatment apparatus 110, which can facilitate or improve the process of wound dressing or pump replacement (if desired). Any of the pump assemblies disclosed herein may have any suitable connection between the conduit 108 and the pump.
The wound treatment apparatus 110 may deliver a negative pressure of about-80 mmHg, or between about-20 mmHg and-200 mmHg. It should be noted that these pressures are relative to normal ambient atmospheric pressure, so that-200 mmHg would actually be about 560mmHg. In some cases, the pressure range may be between about-40 mmHg and-150 mmHg. Alternatively, pressure ranges up to-75 mmHg, up to-80 mmHg, or above-80 mmHg may be used. In addition, in some cases, a pressure range below-75 mmHg may be used. Alternatively, the wound treatment apparatus 110 may supply a pressure range above about-100 mmHg or even-150 mmHg.
As will be described in greater detail below, the negative pressure wound therapy system 100 may be configured to provide a connection 332 to a separate or remote computing device 334'. Connection 332' may be wired or wireless (e.g., bluetooth Low Energy (BLE), near Field Communication (NFC), wiFi, or cellular). The remote computing device 334' may be a smart phone, a tablet, a notebook or another standalone computer, a server (e.g., cloud server), another pump device, etc.
Fig. 1B illustrates another negative pressure wound therapy system 100. The negative pressure wound therapy system 100 may have any of the components, features, or other details of any of the other negative pressure wound therapy systems disclosed herein, including but not limited to the negative pressure wound therapy system 100' shown in fig. 1A or the negative pressure wound therapy system 1400 shown in fig. 10, in combination with or in place of any of the components, features, or other details of the negative pressure wound therapy system 100 shown in fig. 1B and/or described herein. The negative pressure wound therapy system 100 may have a wound cover 106 over the wound 104 that may seal the wound 104. A catheter 108, such as a single lumen tube or a multi-lumen tube, may be used to connect the wound cover 106 with a wound treatment device 110 (sometimes referred to in whole or in part as a "pump assembly") configured to supply reduced pressure or negative pressure. Wound cover 106 may be in fluid communication with wound 104.
Referring to fig. 1B, the catheter 108 may have a bridging portion 130, which may have a proximal portion and a distal portion (the distal portion being closer to the wound 104 than the proximal portion), and an applicator 132 at the distal end of the bridging portion 130, thereby forming a flexible suction adapter (or catheter) 108. A connector 134 may be provided at the proximal end of the bridge portion 130 for connection to at least one of the channels, which may extend along the length of the bridge portion 130 of the catheter 108 shown in fig. 1B. The cap 140 may be coupled with a portion of the conduit 108 and, in some cases, as shown, may be attached to the connector 134. Cap 140 may be used to prevent leakage of fluid from the proximal end of bridge portion 130. The catheter 108 may be a soft port manufactured by Smith & Nephew. As mentioned, the negative pressure wound therapy system 100 may include a negative pressure source, such as a device 110, capable of supplying negative pressure to the wound 104 through the conduit 108. Although not required, the device 110 may also include a canister or other container for storing wound exudate and other fluids that may be removed from the wound.
The device 110 may be connected to the connector 134 via a conduit or tube 142. In use, the applicator 132 may be placed over an aperture formed in the cover 106 that is placed over a suitably prepared wound or wound 104. Subsequently, with wound treatment device 110 connected to connector 134 via tube 142, wound treatment device 110 may be activated to supply negative pressure to the wound. The application of negative pressure may be applied until the desired level of healing of the wound is achieved.
The bridge portion 130 may include an upper channel material or layer positioned between the upper layer and the middle layer, with a lower channel material or layer positioned between the middle layer and the bottom layer. The upper, middle and lower layers may have an elongated portion extending between a proximal end and a distal end and may comprise a material that is fluid impermeable, such as a polymer, for example polyurethane. Of course, it should be appreciated that the upper, middle and lower layers may each be composed of different materials including semi-permeable materials. In some cases, one or more of the upper, middle, and lower layers may be at least partially transparent. In some cases, the upper and lower layers may be curved, rounded, or convex outward over most of their length.
The upper and lower channel layers may be elongate layers extending from the proximal end to the distal end of the bridge 130 and may each preferably comprise a porous material including, for example, an open cell foam such as polyethylene or polyurethane. In some cases, one or more of the upper and lower channel layers may be composed of a fabric (e.g., a knitted or woven spacer fabric (such as a knitted polyester 3D fabric, baltex7970.Rtm., or gehringer 879. Rtm.)) or a nonwoven material or a loop-knitted or loop pile material. The fibers may not necessarily be woven and may include felted and flocked (including materials such as flotex. Rtm) fibrous materials. The material selected is preferably adapted to channel wound exudate away from the wound and to transmit negative pressure or exhaust air to the wound site and may also impart a degree of kink or blockage resistance to the channel layer. In one example, the upper channel layer may comprise an open cell foam, such as polyurethane, and the lower channel layer may comprise a fabric. In another example, the upper channel layer is optional and the system may instead be provided with an open upper channel. The upper channel layer may have a curved, rounded or upwardly convex upper surface and a substantially flat lower surface, and the lower channel layer may have a curved, rounded or downwardly convex lower surface and a substantially flat upper surface.
The fabric or material of any of the components of bridge 130 may have a three-dimensional (3D) structure in which one or more types of fibers form a structure in which the fibers extend in all three dimensions. In some cases, such fabrics may assist in wicking, transporting fluids, or transmitting negative pressure. In some cases, the material of the fabric or channel may include several layers of material stacked or laminated on top of each other, which may in some cases be used to prevent the channel from collapsing under the application of negative pressure. The materials used in some embodiments of the catheter 108 may be conformable and pliable, which in some cases may help avoid pressure ulcers and other complications that may be caused by the wound treatment system pressing against the patient's skin.
The distal ends of the upper, middle and lower layers and the channel layer may be enlarged at their distal ends (for placement over the wound site) and may form "tear drops" or other enlarged shapes. At least the upper, middle and lower layers and the distal end of the channel layer may also be provided with at least one through-going aperture. This orifice may be used not only to drain wound exudate and apply negative pressure to the wound, but also during manufacture of the device, as the orifices may be used to properly align the respective layers.
In some embodiments, a controlled gas leak 146 (sometimes referred to as a gas leak, an air leak, or a controlled air leak) may be provided on the bridge portion 130, for example at a proximal end thereof. This air leakage 146 may include an opening or channel extending through the upper layer of the bridge portion 130 such that the air leakage 146 is in fluid communication with the upper channel of the bridge portion 130. When suction is applied to the conduit 108, gas (e.g., air) may enter through the gas leakage ports 146 and move along the upper channel of the bridge portion 130 from the proximal end of the bridge portion 130 to the distal end of the bridge portion. The gas may then be pumped into the lower channel of the bridge portion 130 through apertures through the distal ends of the upper, middle and lower layers.
The air leakage 146 may include a filter. Preferably, the air leak 146 is located at the proximal end of the bridge portion 130 so as to minimize the likelihood of wound exudate or other fluids contacting and possibly blocking or interfering with the air leak 146 or filter. In some cases, the filter may be a microporous membrane capable of excluding microorganisms and bacteria and may be capable of filtering out particles greater than 45 microns. Preferably, the filter may exclude particles greater than 1.0 microns, and more preferably, greater than 0.2 microns. Advantageously, some embodiments may provide filters that are at least partially chemically resistant to, for example, water, common household liquids such as shampoos, and other surfactants. In some cases, again applying a vacuum to the suction adapter or wiping the exposed exterior portion of the filter may be sufficient to clear any foreign matter that may clog the filter. The filter may be constructed of a polymer of suitable resistance such as acrylic, polyethersulfone or polytetrafluoroethylene, and may be oleophobic or hydrophobic. In some cases, the gas leakage 146 may supply a relatively constant flow of gas that does not increase significantly as additional negative pressure is applied to the conduit 108. In the example of negative pressure wound therapy system 100 in which the flow of gas through gas leakage port 146 increases as additional negative pressure is applied, preferably this increased flow of gas will be minimized and not increase in proportion to the negative pressure applied thereto. Other descriptions of such bridges, conduits, air leaks, and other components, features, and details that may be used with any of the embodiments of the negative pressure wound therapy system disclosed herein may be found in U.S. patent No. 8,801,685, which is incorporated by reference in its entirety as if fully set forth herein.
Any of the wound treatment devices disclosed herein (e.g., device 110 or 110') may provide continuous or intermittent negative pressure therapy. The continuous treatment may be delivered at greater than 0mmHg, -25mmHg, -40mmHg, -50mmHg, -60mmHg, -70mmHg, -80mmHg, -90mmHg, -100mmHg, -120mmHg, -125mmHg, -140mmHg, -160mmHg, -180mmHg, -200mmHg, or less than-200 mmHg. Intermittent therapy may be delivered between a low negative pressure set point and a high negative pressure set point (sometimes referred to as a set point). The low set point may be set above 0mmHg, -25mmHg, -40mmHg, -50mmHg, -60mmHg, -70mmHg, -80mmHg, -90mmHg, -100mmHg, -120mmHg, -140mmHg, -160mmHg, -180mmHg, or below-180 mmHg. The high set point may be set above-25 mmHg, -40mmHg, -50mmHg, -60mmHg, -70mmHg, -80mmHg, -90mmHg, -100mmHg, -120mmHg, -125mmHg, -140mmHg, -160mmHg, -180mmHg, -200mmHg, or below-200 mmHg. During intermittent treatment, negative pressure at a low set point may be delivered for a first duration, and after expiration of the first duration, negative pressure at a high set point may be delivered for a second duration. After the second duration expires, a negative pressure at a low set point may be delivered. The first duration and the second duration may be the same or different values.
In operation, wound filler 102 may be inserted into the cavity of wound 104 and wound cover 106 may be placed to seal wound 104. Wound treatment apparatus 110 may provide negative pressure to wound cover 106, which may be transmitted to wound 104 via wound filler 102. Fluids, such as wound exudate, may be drawn through the conduit 108 and stored in the canister. In some cases, the fluid is absorbed by the wound filler 102 or one or more absorbent layers (not shown).
Wound Dressings that may be used with the pump assemblies and systems of the present application include Renasys-F, renasys-G, renasysAB and Pico Dressings available from Smith & Nephew. Other descriptions of such wound dressings and other components of negative pressure wound therapy systems that may be used with the pump assemblies and systems of the present application may be found in U.S. patent publication nos. 2012/016334, 2011/0213287, 2011/0282309, 2012/013685, and 9,084,845, each of which is incorporated by reference in its entirety as if fully set forth herein. In some cases, other suitable wound dressings may be used.
Fig. 2A-2I illustrate an arrangement of a negative pressure wound therapy device 110. In some arrangements, as will be described, the negative pressure wound therapy device 110 may have a pump assembly 160 with a modular design, wherein many of the sub-components of the pump assembly 160 are grouped and designed in modules. This modular arrangement of the various components of the pump assembly 160 may make it easier and faster to remove and replace any malfunctioning components of the pump assembly 160.
As shown, the pump assembly 160 and canister 162 may be connected, thereby forming the wound treatment apparatus 110. The pump assembly 160 may include a user interface, a communication interface, negative pressure generation and control, and alert generation. Some arrangements of the pump assembly 160 may include a housing whose primary function is to enclose or house electronics and other components. The housing may provide patient safety and isolation from the interior of the device, may protect the pump device from impact damage, and may provide aesthetic appeal. The housing may also provide a transparent window to allow a user to view the display. The main housing can be easily removed without disturbing the rest of the device and component connection (i.e. can be removed without disconnecting any electrical connectors), thereby making maintenance simpler.
The pump assembly 160 may also include a core assembly (such as core assembly 212), also referred to as a core module. Some arrangements of the core assembly may include all or nearly all of the electrical and mechanical components and features required for user interface, negative pressure control, and battery operation. In some arrangements, the core assembly may be a central subassembly of the pump assembly and may be configured as a component that is easily extractable from the pump assembly to make maintenance and repair easier and faster.
The core assembly can be easily separated into individual components for ease of maintenance, cleaning and assembly. The pump assembly 160 may also include a rear trim panel that may provide a USB interface, a charger port, and a speaker. The rear fascia panel can be easily removed (e.g., by removing two screws and associated screw cover plates) to allow for quick repair of the charger connector, which may be damaged by device misuse. The pump assembly 160 may also include a handle or carrying strap to allow for easy portability of the device.
Referring to fig. 2I, the pump assembly 160 can include an interface panel 170 having a display 172, one or more indicators 174, or one or more controls or buttons (including, for example, but not limited to, a treatment start and pause button 180 or an alarm/alert mute button 182). Some arrangements of lenses for displays may be made of polycarbonate with a hard coating or of polymethyl methacrylate. The interface panel 170 may have one or more input controls or buttons 184 (three shown) that may be used to control any function of the pump assembly 160 or the interface panel 170. For example, and without limitation, one or more of the buttons 184 may be used to turn the pump assembly 160 on or off, start or pause a treatment, operate and monitor operation of the pump assembly 160, scroll through menus or controls displayed on the display 172, or perform other functions. In some cases, the command button 184 may be programmable and may be made of soft-touch rubber.
In some arrangements, the interface panel 170 may be substantially planar and may be slightly angled relative to a horizontal plane toward the front surface of the pump assembly 160. For example, and without limitation, some arrangements of interface panel 170 may be tilted forward relative to the horizontal by 20 ° (or about 20 °), or 15 ° (or about 10 ° or less than 10 °) to 30 ° (or about 30 ° or more than 30 °), or any angle within the foregoing ranges.
The interface panel 170 may have a visual indicator 186 that may indicate which of the one or more buttons 184 is in an active state. The interface panel 170 may also have a lock/unlock control or button 188, which may be configured to selectively lock or unlock various buttons (e.g., button 184) or functions of the display 172. In some arrangements, when the lock/unlock button 188 is in the locked state, pressing one or more of the various other buttons or the display will not cause the pump assembly 160 to change any display or performance functions of the device. In this way, the interface panel 170 will be protected from inadvertent collisions or touches by various buttons or displays. In some arrangements, the interface panel 170 may be configured such that when the device and/or interface panel 170 is in a locked state, one or more of the buttons on the interface panel 170 may be used, but in the locked state, adjustment of the treatment settings of the device will be prevented or prevented. The interface panel 170 may be located on an upper portion of the pump assembly 160, such as, but not limited to, an upwardly facing surface of the pump assembly 160.
The display 172 may be a screen, such as an LCD screen, may be installed in a middle portion of the interface panel 170. The display 172 may be a touch screen display. The display 172 may support playback of Audio Visual (AV) content (e.g., instructional video) and present a plurality of screens or Graphical User Interfaces (GUIs) for configuring, controlling, and monitoring operation of the pump assembly 160.
The one or more indicators 174 may be lights (e.g., LEDs) and may be configured to provide a visual indication of an alarm condition and/or a status of the pump. For example, but not limited to, one or more indicators 174 may be configured to provide a visual indication of the status of pump assembly 160 or other components of negative pressure wound therapy system 100, including but not limited to catheter 108 or wound cover 106 (such as to provide an indication of normal operation, low battery, leakage, canister fill, blockage, overpressure, etc.). For example, and without limitation, one or more indicators 174 may indicate to a user (e.g., patient, healthcare provider, etc.) various operational or fault conditions of pump assembly 160, including alerting the user to a normal or proper operational condition, pump failure, powering a pump or power failure, detecting a leak in the wound cover or flow path (sometimes referred to as a fluid flow path), suction blockage in the flow path, canister filling, overpressure, and/or any other similar or suitable condition or combination thereof. For example, and without limitation, one or more indicators 174 may indicate to a user (e.g., patient, healthcare provider, etc.) a system normal state, a battery level charge state or a state in which the battery is being actively charged, and/or an alarm or alert state. Any one or more suitable indicators may additionally or alternatively be used, such as visual, audio, tactile indicators, and the like.
Fig. 2C illustrates a rear or rear view of the wound treatment apparatus 110 shown in fig. 2A. As shown, the pump assembly 160 may include a speaker 192 for producing sound. For example, and without limitation, the speaker 192 may generate an acoustic alarm in response to deviations in therapy delivery, compliance with therapy delivery, or any other similar or suitable condition or combination thereof. Speakers 192 may provide audio to accompany one or more instructional videos that may be displayed on display 172.
The pump assembly 160 may be configured to provide easy access to one or more filters (e.g., antibacterial filters) of the pump assembly 160 (e.g., access doors on the housing of the pump assembly). This may enable a user (e.g., a healthcare provider or patient) to more easily access, examine, or replace such filters. The pump assembly 160 may also include a power jack assembly 196 (which may include a power cord) for providing power to the pump assembly 160 or for charging and recharging an internal power source, such as a battery. Some embodiments of pump assembly 160 may include a disposable or rechargeable power source, such as one or more batteries, such that a power socket is not required. The pump assembly 160 may have a recess 198 formed therein to facilitate gripping of the pump assembly 160.
Canister 162 may hold fluid aspirated from wound 104. For example, the canister 162 may have a canister 346 having a capacity of 800mL (or about 800 mL), or 300mL or less to 1000mL or more, or any capacity level within this range. Tank 162 may include tubing for connecting tank 346 to conduit 108 to form a fluid flow path. For example, when the canister 162 has been filled with fluid or when the user has completed her or his treatment, the canister 162 may be replaced with another canister.
In some arrangements, canister 162 may include a low cost disposable assembly that stores exudates that have been extracted from the wound. Canister 162 may be non-sterile and may be designed for single use, and may be disposed of after collecting exudates from a single user. Canister 162 will collect wound exudate and may be available with and without a curing agent. The solidifying agent may solidify the exudates collected in the tank. The canister 162 may be secured below the pump assembly 160 using a locking mechanism as will be described.
Referring to fig. 2F, the wound treatment apparatus 110 may include a canister inlet tube 142 in fluid communication with a canister body 346 of the canister 162. The canister inlet tube 142 may be coupled with a dressing port connector 144, which may be used to connect with the catheter 108.
The canister 162 may be selectively coupleable and removable from the pump assembly 160. Referring to fig. 2H, in some cases, the canister release button 202 may be pressed to selectively release the canister 162 from the pump assembly 160. Referring to fig. 2C, the canister 162 may have one or more fill lines or graduations 204 to indicate to a user the amount of fluid or exudate stored within the canister 162.
The wound treatment apparatus 110 may have a handle 208 that may be used to lift or carry the wound treatment apparatus 110. The handle 208 may be coupled with the pump assembly 160 and rotatable relative to the wound treatment apparatus 110 such that the handle may be rotated upward for lifting or carrying the wound treatment apparatus 110 or the pump assembly 160, or rotated into a lower profile in a more compact position when the handle is not in use. In some cases, the handle 208 can be coupled with the pump assembly 160 in a fixed position. Handle 208 may be coupled to an upper portion of pump assembly 160 or may be removable from wound treatment apparatus 110.
Fig. 3A is an exploded view of the pump assembly 160. Some arrangements of the pump assembly 160 have been designed to facilitate removal of components and sub-components of the pump assembly 160 from the pump assembly 160 for cleaning, maintenance, replacement, or other ease. As will be described, some arrangements of the pump assembly 160 are designed such that various components and/or subassemblies are arranged and assembled in the pump assembly 160 in a modular manner to facilitate removal, cleaning, and/or maintenance of the various components and subassemblies. In some arrangements, the pump assembly 160 can have a housing 210 sized and configured to enclose at least a core assembly 212. The housing 210 may be made of acrylonitrile butadiene styrene or any other desired or suitable material.
The core base seal 214 may be used to seal the collection tank 162 to the bottom of the pump assembly 160. A plurality of screws or other fasteners 215 may be used to couple the core assembly 212 with the housing 210. The rear trim assembly 216 may be coupled to the housing 210 using one or more fasteners 217, which may have one or more screws or fastener covers 219. Some arrangements of the rear trim component 216 may have a USB port 199 or other wired connection ports that may be included in the rear trim component 216 that couple with the printed circuit board 201. The rear trim component 216 may include a speaker 192 and may have other components or connectors, buttons, switches, or inputs. USB cover 221 may be removably coupled with a USB port.
In some arrangements, the power cord 196 may be part of a power jack assembly and/or may be directly connected to the rear trim assembly 216. The power cord 196 or other components of the power jack assembly or other components in electrical communication with the power cord 196 may extend through the rear trim assembly 216 and be electrically coupled to the electrical components of the rear trim assembly 216 and/or other components of the pump assembly 160. In some arrangements, a power jack assembly, which may include a power cord 196, may be connected to the rear trim assembly 216. In some arrangements, the power jack assembly and pump device 160 may be configured such that the power cord 196 may be more easily removed and replaced than a model in which the power cord is directly connected to internal electronic components within the pump, which may require a service technician to disassemble the pump to replace the power cord, possibly remove and make a new welded connection, etc. In some arrangements of the pump assembly 160, the service technician need only remove the power jack assembly from the rear trim assembly 216 and install a new power jack assembly to replace the power cord 196, or in some arrangements remove and replace the power jack assembly and/or the rear trim assembly 216 to which the power cord 196 is attached to replace the power cord 196.
Handle 208 may be coupled with post 209 of housing 210 configured to pivot relative to housing 210. In some arrangements, the handle may be made of a thermoplastic elastomer or any other suitable or desired material. In some arrangements, the handle may be configured to simply clamp or snap onto the housing 210. In some arrangements, the handle 208 may be configured to rotate relative to the housing 210, or may be rigidly (non-rotatably) attached to the housing 210. In some arrangements, two or more handle caps 211 may be used to couple the handle 208 with the post 209 of the housing 210, or may be used to cover a recess or depression 213 in the handle 208. The canister release button 202 may extend through an opening 203 in the housing 210.
Referring to fig. 3C, core assembly 212 may include an upper core assembly 226 that may be coupled to core assembly 212 using one or more, or two or more, fasteners 227, which may be screws. The upper core assembly 226 may include a display assembly 228, which may have a 2.8 inch TFT display or a 3 inch display, or any other suitable display. The upper core assembly 226 may include a foam spacer 229 between the display assembly 228 and a printed circuit board 230, which may include a processor, memory device, and other electronic components for operating the display assembly 228 and the pump assembly 160. One or more cable connectors may be used to electronically couple the display assembly 228, the printed circuit board 230, and other components of the core assembly 212. Additionally, one or more buttons and/or indicators 174, 180, 182, 184, 194 and/or other buttons or indicators may be electronically and/or physically coupled with the printed circuit board 230. The display assembly 228, foam spacer 229, and printed circuit board 230 may be supported by a support base 232 (also referred to herein as an upper support) that may be coupled with other components of the core assembly 212 using fasteners 227 such that components of the upper core assembly 226 and components related to the display of the pump assembly 160 may be removed from the pump assembly 160 by removing the support base 232 and, in some arrangements, cable connectors associated with the components of the upper core assembly 226 from the other components of the core assembly 212.
Referring to fig. 3D, the core assembly 212 may include a flow module 236 (or flow manifold) that may be configured to receive air/fluid drawn through the collection tank 162. For example, but not limiting of, the flow module 236 may have an opening 233 or port that may be aligned with the opening 235 in the lower support 264 of the lower core assembly 254 and/or the connector interface 372 of the collection tank 162 such that air/fluid drawn through the opening 373 extending through the connector interface 372 may be drawn through the opening 233 in the flow module 236 by the pump module 248. In this arrangement, the pump module 248 may draw air/fluid through the flow module 236 (positioned upstream of the pump module 248) through a tube or conduit 241 that communicates with an outlet opening or port of the flow module 236 and with a tubing connector 247 (e.g., a first tubing connector 247 a) of the pump module 248. In any of the arrangements disclosed herein, the tubing may have an inner diameter of 1/8 inch.
In some arrangements, the flow module 236 may be coupled with other components of the core assembly 212 using one or more fasteners 237 (three shown). Flow module 236 may be electronically coupled to other components of core assembly 212 using flow module lines 238. As described above and below, two or more flow tubes or three or more flow tubes may be used to provide a fluid flow path from the pump module 248 to a tank or other component. Some arrangements of flow module 236 may include a pressure sensor or a plurality of pressure sensors. In some arrangements, a flow check valve 242 may be used to prevent air from flowing from the pump into the tank. In some arrangements, check valve 242 may have a barbed connector for connection with a pipe and may be made of any suitable material or materials, including but not limited to acrylic and silicone.
The check valve 242 may be coupled with a line or conduit 240 (e.g., first conduit 240 a) that is coupled with a line connector 247 (e.g., second line connector 247 b) of the pump module 248. As described in more detail below, the second conduit 240b may be coupled with a downstream connector or side of the check valve 242 to communicate air/fluid passing through the check valve 242 to the exhaust plenum 250 (also referred to herein as a noise reduction chamber or first noise reduction chamber). For example, and without limitation, second conduit 240b may be coupled with an inlet or opening 255 of exhaust plenum 250 to communicate air/fluid advancing through check valve 242 to exhaust plenum 250, as will be described in more detail below. A conduit clip 244 may be used to hold one or more components of conduit 240 to core assembly 212.
Referring to fig. 3E, the core assembly 212 may include a battery module 246 and a pump module 248. The cover 249 may cover one or more sides of the pump module 248. For example, but not limiting of, a cover 249 may cover the top, back, and sides of the pump module 248. The pump module 248 includes a pump motor. The pump module 248 may include a tubing connector 247 (which may include an inlet tubing connector and an outlet tubing connector) to which tubing may be coupled.
The pump may be a diaphragm pump or any other desired or suitable pump type, including a rotary pump, peristaltic pump, piezoelectric pump, or the like. Some arrangements of diaphragm pumps are well suited for the required flow rates and pressures, have a long maintenance-free service life, and are relatively efficient and quiet in operation.
In any of the arrangements disclosed herein, the pump module 248 may be oil-free, may have low power consumption and low sound level characteristics, and may have a compact and lightweight design. The pump module 248 may have a 12V or 24V motor, may have a maximum flow rating of 4 liters/minute, about 4 liters/minute, 3 liters/minute, or about 3 liters/minute, and may have a maximum intermittent pressure of 1.9 bar. Some arrangements of the pump module 248 may include a pump controller. In some arrangements, the pump module 248 may be a diaphragm pump and a compressor type pump.
The battery module 246 may be any suitable battery pack and may include single-use batteries and rechargeable batteries, such as lithium ion batteries. Some arrangements of batteries may include lithium ion 18650 batteries, or any other type of battery with sufficient or adequate power supply, good power density for size, and/or light weight, although none of these features or characteristics are necessary. The battery module may include a well-designed charging circuit that is fully redundant due to the inherent risks of lithium ion battery technology and may be configured to operate over a limited temperature range. The battery module 246 and/or the pump module 248 may be coupled to or supported by the lower core assembly 254. One or more fasteners 249 and/or tie-down straps may be used to couple the pump module 248 with other components of the core assembly 212.
Referring to fig. 3F, the core assembly 212 may include an exhaust plenum 250 configured to reduce the sound level or noise generated by the pump module 248. In some arrangements, one or more fasteners 252 (two shown) may be used to secure the cover plate 251 to the exhaust plenum 250. Foam element 253 may be positioned within vent chamber 250. The foam element 253 may be sized to fit snugly or tightly within the exhaust chamber 250 and may be configured to attenuate the noise level of the pump module 248 and/or the exhaust from the pump module 248. For example, and without limitation, in some arrangements, the foam element 253 may have a size and shape similar to or the same as the size and shape of the space within the vent chamber 250, or in some arrangements, the foam element 253 may have a shape similar to or the same as the shape of the space within the vent chamber 250, and an oversized size (e.g., 10% greater in volume or dimension, or 5% to 20% greater in volume or dimension) compared to the vent chamber 250. Referring to fig. 3F and 3J, the exhaust chamber 250 may have an inlet 255 and an outlet 257. The inlet may comprise a fitting or port for receiving a pipe or conduit component. The outlet 257 may substantially allow exhaust from the pump module 248 to exit the pump assembly 110.
In addition to the exhaust plenum 250 or without the exhaust plenum 250, some arrangements of the pump assembly may have noise reduction elements in the exhaust flow. In some arrangements, as shown in fig. 3G-3K, the noise reduction element may be or may include an air pulse reduction chamber 460 (also referred to herein as a noise reduction chamber) downstream of the pump module 248. Referring to fig. 3G-3K, the noise reduction chamber 460 may be coupled to a conduit connector 247 (e.g., a second conduit connector 247 b) of the pump module 248 with a conduit or duct 462 such that air/fluid exiting the pump module 248 then passes through the noise reduction chamber 460 before exiting the pump assembly 160. The conduit 462 may be coupled with an access opening or port 464 of the air pulse reduction chamber 460. A second conduit or duct 466 may be coupled with an outlet opening or port 468 of the air pulse reduction chamber 460 such that air/fluid enters an inlet opening 464 of the air pulse reduction chamber 460 and exits the air pulse reduction chamber 460 through the outlet opening 468 of the air pulse reduction chamber 460. In some arrangements, air/fluid exiting the air pulse reduction chamber 460 may then be routed through the conduit 466 via the check valve 470. In some arrangements, the check valve 470 may be the same as or similar to the check valve 242, and vice versa. The tubing or conduit 472 may be coupled with tubing or conduit 476 using a connector 474 (which may be barbed) to communicate air/fluid from the check valve 470 to the exhaust chamber 250.
Referring to fig. 3H and 3K, the air pulse reduction chamber 460 may have a body 480 with ports 464, 468; a cover or plate 482 coupled to the open side of the body 480; and a foam layer 484. The foam layer 484 is optional such that some arrangements do not have a foam layer 484. The cover 482 may be sealingly coupled with the body 480 of the air pulse reduction chamber 460. In some arrangements, the body 480 may be formed such that a separate covering 482 is not required (e.g., where the body 480 and covering 482 are integrally formed, such as by blow molding, 3D printing, or other suitable manufacturing method). The foam layer 484 may be configured to attenuate acoustic pulses from air (or more generally, gas) traveling through the air pulse reduction chamber 460 and/or vibrations in the air pulse reduction chamber 460 to reduce noise and/or stress on the air pulse reduction chamber 460. The body 480 may have a space 481 within the body through which air/fluid entering the inlet opening 464 must pass before exiting the outlet opening 468.
Referring to fig. 3K, some arrangements of the body 480 of the air pulse reduction chamber 460 may have a first inner wall section 490 that may be positioned adjacent to the inlet opening 464. The first inner wall section 490 may have a height equal to or similar to the height of the peripheral wall 483 of the body 480. The first inner wall segment 490 may extend across a portion (e.g., a majority) of the distance across the space 481, so air/fluid entering the inlet opening 464 must pass through the opening/passageway 492 between the end of the first inner wall segment 490 and the peripheral wall 483 before passing through the outlet opening 468. Thus, the first inner wall section 490 acts like a deflector or a diverter or a baffle fin to attenuate the magnitude of the pulse of air flowing from the pump module 248 (which may have a diaphragm pump) through the air pulse reduction chamber 460. Some arrangements of the body 480 of the air pulse reduction chamber 460 may have recesses 494 that may add additional volume to the body 480 of the air pulse reduction chamber 460 to further attenuate the magnitude of the pulses of air flowing through the air pulse reduction chamber 460. Attenuating the magnitude of the pulse of air flowing through the air pulse reduction chamber 460 may reduce the magnitude of the air pulse applied to the check valve 470 downstream of the air pulse reduction chamber 460 to quiet the check valve 470 during operation of the pump assembly 160. Some arrangements of the body 480 may have a second inner wall section (not shown) or three or more inner wall sections sized and positioned to block or deflect air from passing through the air pulse reduction chamber 460.
In some arrangements, the pump module 248 may be configured to exhaust air drawn through the collection tank 162 through an exhaust port (such as through an exhaust outlet or port 257) or one or more exhaust ports. In some arrangements, such as the illustrated arrangement, the pump module 248 may be configured to vent air drawn through the collection tank 162 through one or more spaces, gaps, cracks, or other openings formed in the housing 210 such that the pump assembly 160 does not have a separate vent port on the exterior of the housing 210. This may be accomplished in some arrangements because the canister 162 may have an odor filter integrally formed therein such that any substances or vapors that may be in the exhaust gas may be filtered and removed or substantially removed by the odor filter in the canister before the exhaust gas reaches the inlet port in the pump assembly 160.
Additional details regarding the vent or vent of a pump assembly that may be used with any arrangement of the negative pressure wound therapy system 100 disclosed herein are set forth in published international application WO2019/211732, 11, 7, 2019, which is incorporated herein by reference as if fully set forth herein.
Fig. 4A-4H illustrate an arrangement of the lower core assembly 254. The lower core assembly 254 may have a base support 260, a second support 264 (also referred to herein as a lower support), and a canister release mechanism. In some arrangements, the canister release mechanism may include an actuator 262, a first locking arm 266, and a second locking arm 268. In some arrangements, the button 202 may be coupled with the actuator 262 or integrally formed with the actuator. In addition to supporting the pump module and battery, the lower core assembly 254 may be configured to support a selectively movable locking mechanism that may selectively couple the canister 162 with the pump assembly 160.
One or more fasteners 270 (four shown) may be used to couple the second support 264 with the base support 216. The actuator 262 may be positioned between the base support 260 and the second support 264 and may be slidable relative to the base support 260 and the second support 264 between a first position and a second position. In some arrangements, the actuator 262 is movable along the first axis A1 between a first position and a second position. The first axis A1 may be substantially parallel to an axial centerline of the button 202 and/or the spring 272. In the first position, the actuator 262 may be in a locked or engaged position relative to an upper portion of the canister 162, such as a neck flange or neck portion 274 of the canister 162 (as shown in fig. 3B), such that when the actuator 262 is in the first position, the canister 162 will securely engage with the lower core assembly 254 of the pump assembly 160. For example, and without limitation, the first position of the actuator 262 is shown in fig. 4A, 4D, 4E, and 4F. In the second position, the actuator 262 may be retracted or disengaged from the neck flange or neck portion 274 of the canister 162 such that the canister 162 may be freely removed from the lower core assembly 254 and thus from the pump assembly 160. For example, and without limitation, the second position of the actuator 262 is shown in fig. 4G.
The actuator 262 may be moved from the first position to the second position to press the canister release button 202 or move the canister release button 202 toward the second support 264. A spring or other resilient member 272 may be positioned between a portion of the actuator 262 (e.g., without limitation, adjacent the canister release button 202) and the second support 264 to bias the actuator 262 toward the first position. In this configuration, if the actuator 262 is in the second position, releasing the canister release button 202 will cause the spring 272 to automatically move the actuator 262 from the second position to the first position.
Some arrangements of the actuator 262 may have a base portion 263 and an opening 280 that is large enough to receive a neck portion 274 of the can 162 (such as, for example, but not limited to, when the actuator 262 is in the second position), the opening extending through the base portion 263 and being generally perpendicular to the base portion. The actuator 262 may also have a protrusion or latch 282 that may extend into the opening 280 such that the latch 282 engages the neck portion 274 when the actuator 262 is in the first position. The actuator 262 may be arranged such that the latch 282 moves between the first and second positions when the actuator moves between the first and second positions. The button 202 may extend away from a tab portion or flange 284 of the actuator 262 in a direction parallel to the first axis A1. The button 202 may extend or protrude in a direction substantially perpendicular to the axial centerline A2 of the opening 280 in the actuator 262. Referring to fig. 4C, can release button 202 may extend away from opening 280 through an opening 281 formed in a tab portion of flange 283 that protrudes away from base portion 298 of base support 260. Additionally, the actuator 262 may be configured such that the actuator 262 moves between the first position and the second position in a direction substantially perpendicular to the axial centerline A2 of the opening 280.
The actuator 262 may have a first set of slots 290 arranged in a direction generally parallel to the first axis A1. The actuator 262 may have a second set of grooves 292 disposed at an angle relative to the direction of the first axis A1, for example, at an angle of about 45 ° relative to the first axis A1, or 40 ° to 50 °, or 30 ° to 60 ° relative to the first axis A1. Groove 290 may be configured to receive a first protrusion 296 and a second protrusion 297 extending from a base portion 298 of base support 260. The length of the groove 290 may be long enough to allow the actuator 262 to move between the first position and the second position before the protrusions 296, 297 inhibit movement of the actuator 262.
The first locking arm 266 may have an opening 269 extending through the body portion 271 of the first locking arm 266 that may be configured to receive a first tab 296 extending from the base support 260. The opening 269 may extend through the first locking arm 266 in a direction substantially parallel to an axial centerline A2 of the opening 280 extending through the actuator 262. The first locking arm 266 may be configured to rotate about the first protrusion 296. For example, where the first protrusion 296 extends through the opening 269 in the first locking arm 266, the opening 269 may rotate about the first protrusion 296 as the first locking arm 266 rotates about the first protrusion 296.
Similarly, the second locking arm 268 may have an opening 273 extending through the body portion 275 of the second locking arm 268 that may be configured to receive a second one of the projections 296 extending from the base support 260. The opening 273 may extend through the second locking arm 268 in a direction substantially parallel to an axial centerline A2 of the opening 280 extending through the actuator 262. The second locking arm 268 may be configured to rotate about the second protrusion 297. For example, where the second protrusion 297 extends through the opening 273 in the second locking arm 268, the opening 273 may rotate about the second protrusion 297 as the second locking arm 268 rotates about the second protrusion 297.
The second set of slots 292 may be configured to receive the protrusions 300, 302 extending from the body portions 271, 275 of the first and second locking arms 266, 268, respectively. The length of the groove 292 may be sufficient to allow movement of the protrusions 300, 302 of the first and second locking arms 266, 268 as the first and second locking arms 266, 268 rotate about the first and second protrusions 296, 297. The groove 292 may also limit the range of movement of the first and second locking arms 266, 268 as the first and second locking arms 266, 268 rotate about the first and second protrusions 296, 297. The second set of slots 292 may be angled and configured to rotate the first and second locking arms 266, 268 radially outward from the first position of the first and second locking arms 266, 268 to the second position by applying a force on the protrusions 300 of the first and second locking arms 266, 268 as the actuator 262 moves from the first position to the second position of the actuator 262.
The first locking arm 266 and the second locking arm 268 may be configured to move or rotate between a first position and a second position. In the first position, the protrusions or latches 304 and 306 of the first and second locking arms 266 and 268 may overlap and engage (such as shown in fig. 4D, 4E) the flange or neck portion 274 of the can 162 or cap assembly 360—i.e., may overlap the radially extending surface 375 of the flange or neck portion 274 of the can or cap assembly 360. In the second position, as shown in fig. 4D, 4G, the projection or latch 304 of the first locking arm 266 and the projection or latch 306 of the second locking arm 268 are disengaged from the flange or neck portion 274 of the canister 162.
Some arrangements of base support 260 may have a slot 320 formed in base portion 298 of base support 260. The slot 320 may be configured to receive a second projection 322 extending away from the second surfaces of the first and second locking arms 266, 268. The protrusions 322 extending away from the second surfaces of the first and second locking arms 266, 268 may extend in a direction opposite to the direction in which the protrusions 300 extend from the first and second locking arms 266, 268. The slot 320 may be configured to allow the protrusions 322 of the first and second locking arms 266, 268 to translate along the slot 320 as the first and second locking arms 266, 268 move between the first and second positions. In addition, base support 260 may have an opening 321 formed through base portion 298 of base support 260, opening 321 extending generally in a direction parallel to an axial centerline A2 of opening 280 of actuator 262. The opening 321 may be large enough to receive a flange or neck portion 274 of the can 162 therein.
In some cases, the spring 272 may be positioned axially against a bearing surface 330 formed on a portion of the second bearing 264. The central protrusion 332 may also extend away from the bearing surface 330 to limit movement of the end portion of the spring member 272 relative to the surface of the bearing surface 330. The recess 334 may be formed in a flange portion 336 formed around the bearing surface 330. The recess 334 may be configured to receive a tab portion or flange 284 of the actuator 262 when the actuator 262 is moved from the first position to the second position.
Some arrangements of the tank 162 may have a tank 346 having one or more angled protrusions 348 formed on an upper surface 349 of the tank 346. The actuator 262 may have a first projection or tab 350 and a second projection or tab 352 that may extend through openings 354, 356, respectively, formed through a base portion 298 of the base support 260. The first and second projections 350, 352 may extend in a direction substantially parallel to an axial centerline A2 that extends through an opening 280 formed in the actuator 262. The protrusion may move from the first position to the second position when the first position of the actuator 262 is to the second position of the actuator 262. The first tab 350 and the second tab 352 may interact with an angled or angled surface of one or more angled tabs 348 formed on an upper surface 349 of the can 162. In some arrangements, as the first and second projections 350, 352 move along the angled surfaces of the angled projections 348, the first and second projections 350, 352 may apply a force to the angled projections 348 to move the canister 162 away from the base support 260 of the lower core assembly 254 as the actuator 262 moves from the first position to the second position. This may facilitate removal of the canister 162 from the pump assembly 160.
In other arrangements, the tab 348 formed on the upper surface 349 of the canister 162 may be used to facilitate one-handed removal of the canister 162 from the pump assembly 160, but not to urge the canister 162 away from the pump assembly 160 as described with respect to other arrangements above. Protrusions 348 formed on an upper surface 349 of the canister 162 may engage the first protrusion 350 and the second protrusion 352 to retain the first protrusion 350 and the second protrusion 352 in the open position, thereby allowing a user to remove the canister 162 from the pump assembly 160 without requiring the user to retain the first protrusion 350 and the second protrusion 352 in the open position. For example, as described above, pressing the canister release button 202 will cause the first tab 350 and the second tab 352 of the actuator 262 to move on the sloped surface of the tab 348 formed on the upper surface 349 of the canister 162 until the first tab 350 and the second tab 352 have moved beyond the tab 348. In this position, the orthogonal surfaces of the projection 348 on the canister 162 will prevent the first and second projections 350, 352, and thus the actuator 262, from moving back to the initial or locked position so that the user can then remove the canister 162 from the pump body 160 without having to continue to press the canister release button 202. In this arrangement, the user can remove the canister 162 from the pump assembly 160 with a single-handed operation (i.e., with one hand).
The canister 162 may be configured to include all disposable or serviceable items typically associated with the use of the canister or canister (including, for example and without limitation, sealing rings or gaskets for sealing the canister and the odor filter) as part of a removable canister component such that when the canister 162 is removed from the pump assembly 160, the sealing rings and odor filter will be removed with the canister. This may increase the efficiency and ease with which new canisters may be installed on the pump assembly 160, such that "inter-patient" maintenance may be simplified. In some arrangements, maintenance of "inter-patient" may include the following steps, or in some arrangements, may include only the following steps: the method includes removing the used or partially filled canister 162, cleaning at least an outer surface of the pump assembly 160 with a sanitizing cleaner, installing a new canister 162, and performing a self-test of the pump assembly 160 via a user interface of the pump assembly 160. Furthermore, this may greatly simplify maintenance procedures and allow for simpler funding purchase and lease supply modes for some arrangements of negative pressure wound therapy system 100.
In some arrangements, the canister 162 may include a canister body 346. Some arrangements of the can 346 may include a blow molded one piece design made of a transparent polymer that may allow for the viewing of exudates, or a translucent polymer that allows for the determination of the level of exudates. Canister 346 may be made of a natural translucent material such as polypropylene or high density polyethylene that is low cost and non-toxic.
Some arrangements of canister 162 may have a cap assembly 360 that may be configured to removably couple (e.g., without limitation, threadably couple) with an opening of canister 346. Fig. 5A-5E illustrate an arrangement of a cap assembly 360 that may be included in any of the cans 162 disclosed herein. Referring to fig. 5A-5E, some arrangements of cap assembly 360 may include a cover 362 having a flange 274 (which may be an annular flange) and an opening 363 extending axially through a central portion of first cap member 362.
Cap assembly 360 may also have a cap body 370 with a connector interface 372 protruding axially away from first major surface 371 of cap body 370. The connector interface 372 may have a generally cylindrical shape and an opening 373 extending axially therethrough. The opening 373 may be configured to provide a fluid pathway for air and/or other gases within the tank 346 to pass through and exit through the tank 346. The connector interface 372 may also have an annular groove 374 configured to receive and support a seal ring 376 therein. The sealing ring 376 may be a rubber O-ring or an O-ring from silicone or from another suitable material.
Cap assembly 360 may also have a hydrophobic filter 386 and an odor filter 390. The odor filter 390 may also be configured to filter out bacteria from air flowing through the filter 390. The hydrophobic filter 386 may be used to prevent any liquid from escaping from the canister 346 through the opening 373 in the cap 370 and may be positioned on either or both sides of the odor filter 390. Odor filter 390 may include any suitable filter membrane or material, including carbon. For example, and without limitation, some arrangements of the odor filter 390 may include compressed carbon.
Conventional negative pressure wound therapy pumps are often complained of bad odors. Since the odor filter is typically placed on the exhaust of the device, over time, odors have a tendency to accumulate within the internal piping and pump motor. The arrangement of the present disclosure provides a filter (e.g., filter 390) at canister 162 to prevent, or at least inhibit, the passage of any bacteria or other odor-causing substances out of canister 162 by preventing such bacteria or other odor-causing substances from passing through cap assembly 360 into pump assembly 160. This arrangement also has the benefit of preventing the accumulation of bacteria and other odor causing substances from contaminating the pump assembly 160, thereby allowing the pump assembly 360 to be reused without requiring substantial cleaning of the air passageway through the pump assembly 360.
In some arrangements, filter 390 may include a carbon activated foam material. In some arrangements, the filter 390 may include a compressed carbon element as part of a filtration system in the canister. The carbon element may have various shapes and sizes depending on the canister. The carbon element may be a first part of the filtration system, followed by a hydrophobic membrane. In some arrangements, this will ensure that when air is drawn from the canister to the pump, the scent is what is first filtered. As shown, this filtration system may be attached to or form part of a canister cap assembly 360. Additionally, including an odor filter in the canister may eliminate the expensive and more difficult task of replacing the odor filter inside the pump assembly.
Carbon filters of different sizes and shapes may be employed to increase their effectiveness for different tank shapes. However, the precondition of having a filtration system where air must pass through the carbon disc and then through the hydrophobic membrane remains the same for each of these different sizes and shapes of carbon filter element and cap assembly 360. For any arrangement, a spacer may be placed between the carbon filter and the hydrophobic filter. This may require supporting the membrane and holding the carbon filter in the desired position.
Cap assembly 360 may also include a base cap support 392, which may be configured to provide a support surface for filter 390 and/or other components of cap assembly 360. The base cap support 392 may also have a shield or wall 393 configured to overlap or cover at least a portion of the filter 390 so as to inhibit or prevent liquid or exudates within the tank 346 from splashing onto at least a portion of the filter 390 and/or the hydrophobic filter 386. For example, but not limiting of, shield 393 may overlap at least 40% of the surface area of the first major surface of filter 390, or at least 50% of the surface area of the first major surface of filter 390, or at least 40% to at least 60% of the surface area of the first major surface of filter 390.
Shield 393 may have an opening 394 therein through which air and/or other gases may pass as they are drawn through cap assembly 360 when the pump is in operation. In some arrangements, the shield 393 may block a majority of the surface of the filter 390, or 60% or about 60% of the surface, from exposure to exudates within the canister 346. In other words, in some arrangements, the opening 394 extending through the base cap support 392 may be reduced by 60% or about 60% or more with the shield 393 as compared to an opening through the base cap support 392 that does not include the shield 393. In some arrangements, the opening 394 extending through the base cap support 392 may be reduced by 40% (or about 40% or less) to 80% (or about 80% or more) or 50% (or about 50%) to 70% (or about 70%) as compared to an opening through the base cap support 392 that does not include the shield 393.
The base cap support 392 may have a bottom support or bracket 396 that may support the filter 390. One or more fluid passages 395 may be formed through a bottom support or bracket 396. The passages may communicate with recesses 399 formed in the base cap support 392 such that air passing through the passages 395 may also pass through or fill the recesses 399. In some arrangements, the recess 399 may be sized and configured to receive and support the filter membrane 390 therein. Recess 399 may be configured such that all or substantially all of the air or gas from canister 346 must pass through filter 390 before passing through opening 373 in cap assembly 360. The base cap support 392 may also have an annular flange or lip 402 thereon.
Some arrangements of the base cap support 392 may also include one or more protrusions 400 extending axially away from the upper surface of the cap assembly 360 such that, in operation, the one or more protrusions 400 (two shown) extend into the interior space in the can 346.
Fig. 6A-6F illustrate other arrangements of filters 600 and filter supports 602 that may be used with any of the arrangements of negative pressure wound therapy system 100 disclosed herein in place of or in addition to other filters described herein for other arrangements of negative pressure wound therapy system 100. For example, as shown in fig. 6A, some arrangements of filter 600 and filter support 602 shown therein may filter odors, bacteria, and other substances or materials from air drawn from a collection tank (such as tank 162). The hydrophobic filter 604 may be positioned on one or both sides of the filter 600. Air may flow through a first opening 606 in the filter support 602 and then be forced through the filter 600 and the hydrophobic filter 604 before entering a pump assembly, such as the pump assembly 160. In the variation shown in fig. 6B, air may be forced through a plurality of openings 616 in the filter support 612 before passing through the filter 610 and the hydrophobic filter 614.
In a variation of the filter 610 shown in fig. 6B, the filter 610 may have a dished portion 610a and a conical or conical portion 610B extending downwardly toward the interior of the canister, wherein the filter becomes narrower, for example, as the filter extends away from the dished portion of the filter. The filter support 612 may have a shape that is complementary to the shape of the filter 610. The opening 616 may pass through a conical or tapered portion of the filter support 612. This arrangement may increase the flow path of air through the filter 610 to increase the filtration of air exiting the tank, and may also increase the surface area of the cover over the filter 610 to reduce the amount of splashed or sloshed exudates that the filter 610 may be exposed to within the tank.
A variation of the filter 620 shown in fig. 6C may have a tapered shape that increases in size toward the bottom end of the filter 620 and is narrowest at its upper end. Hydrophobic filter 624 may be spaced from filter 620 by a spacer member 623. Filter support 622 may have a shape complementary to the shape of filter 620, spacer member 623, and hydrophobic filter 624. Openings 626 in the bottom surface of filter support 622 may provide a fluid path for air to pass through filter 620.
Fig. 6D-6F illustrate additional variations in the shape of filters 630, 640, 650 and filter supports 632, 642, 652 that may be used in any arrangement of negative pressure wound therapy system 100 disclosed herein. The hydrophobic filters 634, 644, 654 may be positioned over or near any of the filters 630, 640, 650, and the one or more openings 636, 646, 656 may allow air flow through the filter supports 632, 642, 652.
In some arrangements, the negative pressure wound therapy system 100 may have an odor filter that filters the exhaust flow exiting from the pump module 248. The odor filter that filters the exhaust flow exiting the pump module 248 may be positioned inside the housing 210 or outside the housing 210, which may provide easier access for maintenance and/or replacement of the odor filter (i.e., if located outside the housing 210). In some arrangements, a filter may be attached to the top of the tank 162.
In some arrangements, the operation of such a filter may be described as follows. The pump may draw negative pressure onto the canister contents via the first port, thereby drawing air and exudates from the dressing. The exudate may be separated in the canister and air may be drawn through the pump unit and expelled to the second port. The carbon filter may be attached to the outer surface of the canister and when the canister is properly attached to the device, the filter is pushed up against the second port. The exhaust gas may be forced through a filter (which may be a carbon filter or any other suitable odor and/or bacterial type filter). The filter may remove bacterial byproducts prior to venting the exhaust to the atmosphere.
The arrangement of filters disclosed herein may use simple and low cost filter techniques such as, but not limited to, foam with carbon impregnation. Locating the filter on or in the canister ensures that the filter is also replaced when the canister is replaced. In addition, the filter may also provide exhaust silencing. In some arrangements, the filter may be a wet-side filter located inside the tank. Additionally, in some arrangements, one or more additives may be added to the tank to reduce the number of bacteria or bacterial growth. Furthermore, in some arrangements, the dry filter may be placed in the canister cap, but in a separate compartment accessible only by the pump unit exhaust, rather than at the pump inlet. In some arrangements, this may include two ports on the can cap—an inlet port and an outlet port.
Conventional NPWT pumps generate noise when in operation. Noise tends to come from mechanical movement of components in the pump (typically the pump head), as well as from air being drawn and expelled by the pump. This noise can be annoying to the patient and can be directly related to the outcome of the treatment, as the patient can have a tendency to shut down the pump to stop the noise. Pauses in these treatments delay the wound healing process.
Some arrangements of the pump assembly 160 disclosed herein may include an in-line filter connected to the tubing inside the pump enclosure and an energy dissipating tank for mitigating noise from the pump motor. Some arrangements of the pump assembly 160 may include a filter membrane on an exhaust port on the pump assembly 160. The filter membrane may include a Porex PTFE membrane vent, a Pall Versapor (such as, but not limited to, a Pall Versapor 1200 filter) vent, or any sheet-type membrane attachable to the housing of the pump assembly 160 at the exhaust port. In some arrangements, the filter can have the shape of a disc and can be adhered to the housing of the pump assembly 160. In some arrangements, the filter may be enclosed in a housing, cover, or grip cover that may be attached to an outer surface of the housing of the pump assembly 160. The filter may also include a paper filter sheet. Additionally, some arrangements of filters may be configured to create an impermeable barrier that prevents any fluid from entering the enclosure if the device is inverted or tipped over. In addition, such filters may also be configured to provide additional filtration against unpleasant odors discharged from the pump motor.
In some arrangements, the tubing 142 connected to the tank 162 may have a length sufficient to connect with a dressing or port at least two feet, or at least three feet, or one foot to three feet or more from the tank 162. The conduit 142 may be coupled with a connector 440 extending away from the surface of the tank 162. The connector 440 may be in fluid communication with the interior space within the tank 346 and may be configured to couple with an end portion of the conduit 142. When all or a portion of the conduit 142 is not required, all or a portion of the conduit 142 may be wrapped around the tank 162.
Some arrangements of the negative pressure wound therapy system 100 may be configured to support the tubing 142 on or in the pump assembly 160 and/or the canister 162 in order to manage the tubing 142. Patients have reported that a line, such as line 142, is invasive in everyday life. Because the wound may be on a different part of the body, some arrangements of the negative pressure wound therapy system 100 may be provided with a length of tubing 142 to accommodate the most remotely located wound. Configuring the negative pressure wound therapy system 100 to manage any excess tubing may be beneficial in preventing tripping hazards, preventing tipping hazards, and maintaining a more orderly negative pressure wound therapy system 100. Accordingly, some arrangements of the negative pressure wound therapy system 100 disclosed herein may have one or more clips removably or non-removably attached to the exudate conduit 142 and may be used to secure excess conduits to the negative pressure wound therapy system 100. In some arrangements, the tubing may be wrapped around the pump assembly 160 and/or the canister 162, thereby minimizing the profile of the tubing and allowing the user to control the length of tubing extending away from the negative pressure wound therapy system 100.
Referring to fig. 7A-7B, in some arrangements, one or more line supports 444 (also referred to as clips) may be coupled or attached to the housing 210 (as shown) or canister 346 (not shown) of the pump assembly 160 and may be configured to selectively support the line 142. Some arrangements of the pipeline support 444 may be removably attached or coupled with the tank 346. In addition, the conduit support 444 may have a closed opening 446 through which the conduit 142 may pass, a first open support 448 to which a portion of the conduit may be removably secured or retained, and/or an optional second open support 450 to which a portion of the conduit may be removably secured or retained. The closed opening 446 may be used to non-removably attach the conduit 146 to the conduit support 444. The tube support 444 can also have a retaining portion 454 that can be used to secure the tube support 444 to a receiving portion 456 in the housing 210 of the pump assembly 160. The conduit support 444 may slide into and out of the slot 456 to selectively secure the conduit support 444 to the pump assembly 160 (as shown) or the tank 346 (not shown).
In some embodiments, the conduit support 444 may be secured to the housing 210 using slots or other attachment elements on the housing 210 or canister 346. In this embodiment, the tubing may then be wrapped around the housing 210, and the tubing support 444 secures the additional loop of tubing running around the housing 210 to the housing 210. The pipeline support 444 may also be configured to slide onto the pipeline (e.g., the pipeline may pass through a closed opening 446 in the pipeline support 444) such that the pipeline support is at about a midpoint location on the pipeline. The tubing may then be formed as a coil that is removably secured to the tubing support 444.
As shown, some arrangements of the negative pressure wound therapy system 100 may have two or more tube supports 444, one on each of the two side portions of the negative pressure wound therapy system 100. In other arrangements, depending on the length of tubing 142, negative pressure wound therapy system 100 may have only one tubing support 444 or three or more tubing supports 444. Additionally, the conduit support 444 may be positioned on any desired portion of the pump assembly 160 and/or the tank 162.
The conduit support 444 may have any desired shape or feature. For example, some embodiments of the conduit support 444 may be configured with a band around the opening or retaining portion to retain the conduit 142 to the conduit support 444. In other arrangements, the tubing 142 may be supported in an interior space or cavity within the pump assembly 160 and/or the tank 162 in which the tubing may be rolled up. In this arrangement, the user may pull out a tube of a required or desired length from the interior space, and may then actuate the locking mechanism to secure the remainder of the tube in the interior space. In other arrangements, the tubing may be supported in a bag or cavity attached to the outside of the pump assembly 160 and/or tank 162. In some arrangements, the tubing may be fused together such that the user must separate the portion of the tubing that the user intends to use, with the remainder of the tubing being secured to or held by the negative pressure wound therapy system 100.
In some arrangements, the pump assembly 160 may be configured such that the center of gravity is much lower than in conventional pump assemblies. This may improve the stability of the pump assembly 160 and the negative pressure wound therapy system 100 and reduce the instances of the negative pressure wound therapy system 100 inadvertently tipping over. For example, and without limitation, the center of gravity may be about 40% of the total height of the pump assembly 160 (excluding the handle 208), or 35% (or about 35%) of the total height of the pump assembly 160 (excluding the handle 208) to 50% (or about 50%) of the total height of the pump assembly 160 (excluding the handle 208). Additionally, as shown, buttons and other inputs of the interface panel 170 may be on the top surface of the pump assembly 160 such that the input force applied to the pump assembly 160 is in a primarily downward direction when a user provides physical input to the pump. This may also reduce the chance of the pump assembly 160 being inadvertently inverted when a user provides input into the pump assembly 160.
Fig. 9 shows a schematic diagram of a control system 1300 that may be used with any of the wound treatment devices described herein, such as wound treatment device 110' and/or wound treatment device 110. Control system 1300 may be similar to the electronic components described herein. The electrical components are operable to accept user input, provide output to a user, operate a pressure source, provide a connection, and the like. The first processor (e.g., master controller 1310) may be responsible for user activity and the second processor (e.g., pump controller 1370) may be responsible for controlling another device, such as pump 1390.
An input/output (I/O) module 1320 may be used to control input and/or output to another component or device, such as pump 1390, one or more sensors (e.g., one or more pressure sensors 1325 configured to monitor pressure in one or more locations of a fluid flow path), and so forth. For example, the I/O module may receive data from one or more sensors through one or more ports, such as serial (e.g., I2C), parallel, hybrid ports, and the like. Any of the pressure sensors may be part of the wound treatment apparatus or canister. In some cases, any of the pressure sensors 1325 may be located remotely from the wound treatment apparatus, such as at or near the wound (e.g., in a dressing or a catheter connecting the dressing to the wound treatment apparatus). In such embodiments, any of the remote pressure sensors may communicate with the I/O module via a wired connection, or with one or more transceivers 1340 via a wireless connection.
The host controller 1310 may receive data from and provide data to one or more expansion modules 1360, such as one or more USB ports, SD ports, compact Disk (CD) drives, DVD drives, fireWire ports, thunderbolt ports, PCI Express ports, and the like. The main controller 1310, along with other controllers or processors, may store data in a memory 1350 (such as one or more memory modules), which may be internal or external to the main controller 1310. Any suitable type of memory may be used, including volatile or non-volatile memory, such as RAM, ROM, magnetic memory, solid state memory, magnetoresistive Random Access Memory (MRAM), and the like.
The main controller 1310 may be a general purpose controller, such as a low power processor or a special purpose processor. The master controller 1310 may be configured as a "central" processor in the electronic architecture of the control system 1300, and the master controller 1310 may coordinate activities of other processors such as the pump controller 1370, one or more communication controllers 1330, and one or more additional processors 1380. Main controller 1310 may run a suitable operating system such as Linux, windows CE, vxWorks, etc.
The pump controller 1370 may control the operation of the pump 1390, which may generate a negative pressure or a reduced pressure. Pump 1390 may be a suitable pump such as a diaphragm pump, peristaltic pump, rotary vane pump, rolling pump, screw pump, liquid ring pump, diaphragm pump operated by a piezoelectric transducer, voice coil pump, or the like. The pump controller 1370 may measure the pressure in the fluid flow path using data received from the one or more pressure sensors 1325, calculate the rate of fluid flow, and control the pump. The pump controller 1370 may control a pump actuator (such as a motor) such that a desired negative pressure level is reached in the wound 104. The desired negative pressure level may be a pressure set or selected by a user. The pump controller 1370 may control a pump (e.g., a pump motor) using Pulse Width Modulation (PWM) or pulse control. The control signal for driving the pump may be a 0-100% duty cycle PWM signal. The pump controller 1370 may perform flow rate calculation and detect an alarm. The pump controller 1370 may communicate information to the main controller 1310. The pump controller 1370 may be a low power processor.
Any of the one or more communication controllers 1330 can provide a connection (e.g., a wired or wireless connection 1332). One or more communication controllers 1330 may transmit and receive data using one or more transceivers 1340. The one or more transceivers 1340 may include one or more antennas, optical sensors, optical transmitters, vibration motors or transducers, vibration sensors, acoustic sensors, ultrasonic sensors, and so forth. Any one of the one or more transceivers 340 may function as a communications controller. In this case, one or more of the communication controllers 330 may be omitted. Any of the one or more transceivers 340 may be connected to one or more antennas that facilitate wireless communications. The one or more communication controllers 1330 may provide one or more of the following types of connections: global Positioning System (GPS), cellular connection (e.g., 2G, 3G, LTE, 4G, 5G, etc.), NFC, bluetooth connection (or BLE), radio Frequency Identification (RFID), wireless Local Area Network (WLAN), wireless Personal Area Network (WPAN), wiFi connection, internet connection, optical connection (e.g., using infrared light, bar codes, e.g., QR codes, etc.), acoustic connection, ultrasonic connection, etc. The connection may be used for various activities such as pump assembly location tracking, asset tracking, compliance monitoring, remote selection, log uploading, alarms and other operational data, as well as adjustment of treatment settings, upgrades of software or firmware, pairing, etc.
Any of the one or more communication controllers 1330 may provide dual GPS/cellular functionality. The cellular functionality may be, for example, 3G, 4G or 5G functionality. One or more communication controllers 1330 may communicate information to master controller 1310. Any of the one or more communication controllers 1330 may include internal memory or available memory 1350. Any of the one or more communication controllers 1330 may be a low power processor.
The control system 1300 may store data such as GPS data, therapy data, device data, and event data. Such data may be stored, for example, in memory 1350. This data may include patient data acquired by one or more sensors. The control system 1300 may track and record therapy and other operational data. Such data may be stored, for example, in memory 1350.
Using the connections provided by the one or more communication controllers 1330, the control system 1300 may upload any data stored, maintained, or tracked by the control system 1300 to a remote computing device, such as device 1334. The control system 1300 may also download (e.g., via a connection with the device 1334) various operational data such as treatment selections and parameters, firmware and software patches and upgrades, etc. One or more additional processors 1380 may be employed, such as a processor for controlling one or more user interfaces (e.g., one or more displays). In some cases, any illustrated or described components of control system 1300 may be omitted, depending on the arrangement of the wound monitoring or treatment system in which control system 1300 is used.
Any negative pressure wound therapy device described herein may include one or more features disclosed in U.S. patent No. 9,737,649 or U.S. patent publication No. 2017/0216501, each of which is incorporated by reference in its entirety.
Multi-dressing negative pressure wound therapy
Fig. 10 shows another negative pressure wound therapy system 1400. The system 1400 may include a wound treatment device, such as the wound treatment device 110, capable of supplying negative pressure to one or several wound sites. The wound treatment apparatus 110 may be in fluid communication with one or more wound dressings 1406a, 1406b (collectively 1406) to supply negative pressure to one or more wounds, such as wounds 104a and 104 b. The fluid connection between the wound dressing 1406 and the wound treatment apparatus 110 may be referred to as a fluid flow path (e.g., a path through which fluid drawn from the wound via negative pressure flows). For example, the first fluid flow path may include components that provide a fluid connection from the wound treatment apparatus 110 to the first wound dressing 1406 a. As non-limiting examples, the first fluid flow path may include a path from the wound dressing 1406a to the wound treatment device 110 or a path from the first wound dressing 1406a to an inlet 1446 of a branched attachment (or connector) 1444 that is fluidly connected to the wound treatment device 110. Similarly, the second fluid flow path may include components that provide a fluid connection from the wound treatment apparatus 110 to the second wound dressing 1406 b.
The system 1400 may be similar to the system 100, except that multiple wounds 104a and 140b are being treated by the system 1400. The system 1400 may include any one or more of the components of the system 100, which are shown with the additional letters "a" or "b" in fig. 4 to distinguish between a first wound and a second wound (such as the wounds 104a and 104b, the covers 106a and 106 b). As shown, the system 1400 may include a plurality of wound dressings 1406a, 1406b (and corresponding fluid flow paths) in fluid communication with the wound treatment device 110 via a plurality of suction adapters (such as adapter 108). The suction adapter may include any one or more of the components of the adapter 108, which is shown in fig. 4 as having the additional letter "a" or "b" to distinguish between the first wound and the second wound (e.g., bridging portions 130a and 130b, connectors 134a and 134b, and caps 140a and 140 b).
Without limitation, the suction adapters for systems 1400a and 1400b may include a controlled leakage channel that is fluidly separate from the suction channel. Each wound dressing and fluid flow path may include various features or elements that match or are similar to features or elements of another wound dressing or fluid flow path within the system. For ease of reference, reference numerals without corresponding letters may be used to collectively refer to one or more corresponding features or elements. For example, wound dressing 1406a and wound dressing 1406b may be collectively referred to as wound dressing 1406. However, it should be noted that in some arrangements, the elements collectively referred to are not identical and may have different features or attributes.
In some arrangements, the dressing 1406a, 1406b may be placed over an aperture or opening formed in each of the respective drape or wound covers 106a, 106b that is placed over the appropriately prepared wound 1430a, 1430b, which in some cases may be filled with a wound filler material such as foam or gauze. Wound treatment apparatus 110 may be fluidly coupled with inlet 1446 of connector 1444 via tube 142. Connector 1444 may be fluidly coupled with connectors 134a, 134b that may be fluidly coupled with tubes or conduits 130a, 130b via branches 1445a, 1445b and tubes or conduits 1442a, 1442 b. The tubes or conduits 130a, 130b may be fluidly coupled with the dressings 1406a, 1406 b. Once all of the conduits and dressing components are coupled and operably positioned, the wound treatment apparatus 110 may be activated, thereby supplying negative pressure to the wounds 1430a, 1430b via the fluid flow path. The application of negative pressure may be applied until the desired level of healing of wound 1430 is achieved. Although two wounds and wound dressings are shown in fig. 4, some embodiments of wound treatment apparatus 110 may provide treatment to a single wound (e.g., by closing unused branches 1445a or 1445b of connector 1444) or to more than two wounds (e.g., by adding branches to connector 1444).
In any arrangement disclosed herein, the inlet manifold branch attachment 1444 or conduit may include one or more valves, clamps, caps, air leakage ports, or other flow regulator mechanisms that may be configured to allow fluid into the fluid flow path, or alternatively, to block or restrict fluid flow through or past the fluid flow path. In some arrangements, a valve, air leak, or other flow regulating mechanism in the inlet manifold branch attachment 1444 may be electronically opened or closed. For example, the controller of the wound treatment apparatus 110 may communicate with valves, air leaks, etc. to open or close each valve, air leak, etc. individually or as a whole. This communication may be wired or wireless.
In some arrangements, the system 1400 may apply negative pressure to one or more wounds. The negative pressure level at the one or more wounds (e.g., under the one or more wound dressings) may be sufficiently close to the negative pressure level at the negative pressure source. For example, acceptable pressure levels maintained at the wound site may be within ±1mmHg, ±5mmHg, ±10mmHg, ±25mmHg, etc. of the negative pressure set point. In some arrangements, this pressure may be maintained at this level for 95% (or another suitable percentage) of the time that the system 1400 applies negative pressure thereto. In some arrangements, acceptable pressure levels may include a pressure range between-40 and-120 mmHg. However, other pressure levels may be used as described herein.
One or more air leaks, such as in one or more of the fluid flow paths, may be used to determine one or more operating conditions within the system. For example, the air leak may be a controlled air leak that may allow a relatively constant flow of air, gas, or other fluid into the fluid flow path. In some arrangements, the flow from the air leak into the fluid flow path may be configured and/or controlled so as not to increase significantly as additional negative pressure is applied to the system. However, when steady state has been reached (e.g., when the negative pressure set point has been reached), the presence of an air leak in the system may maintain a substantially constant baseline flow through the system. In turn, the presence of the air leak may require the negative pressure source to work harder to maintain the desired negative pressure level at the wound(s). Thus, the system may determine the presence of one or more operational states (such as a blockage, a leak, a tank full, a suction adapter misalignment, etc.) by monitoring the flow through the fluid flow path(s), which may be measured directly or indirectly based on, for example, monitoring the activity of the negative pressure source.
In some arrangements, each fluid flow path may include an air leak, and each air leak of the respective fluid flow path may allow a different flow rate of air, gas, or other fluid into the system. In other words, each air leak of the system may have a different leak rate. For example, the leak rate of the air leak may be based at least in part on the size or shape of the air leak, whether the air leak includes a filter, the size or porosity level of the filter, the blockage level of the air leak or filter, and so forth. Fluid admitted into the fluid flow path may increase the flow rate of the fluid flow path.
Thus, each fluid flow path of the system 1400 may have a different flow rate. The Total Flow Rate (TFR) of the system 1400 (e.g., an aggregate of flows to each wound dressing) may be monitored, calculated, or determined and then used to determine the operational status of the system 1400. The operational states may include, for example, a "no flow" state (e.g., all flow paths are blocked), a blocked state of one or more flow paths (e.g., a blocked state exists in a first fluid flow path, a blocked state exists in a second fluid flow path, etc.), a tank full state, normal operation (e.g., no blocking exists in any fluid flow path), and so forth.
The system 1400 may include one or more features disclosed in U.S. patent publication No. 2020/0069850 or international publication No. WO2018/167199, each of which is incorporated by reference in its entirety.
In some arrangements, the system 1400 may be able to provide an indication, such as an alarm, to communicate the operational status of the system 1400 to the user based on a comparison of the determined total flow rate to one or more flow thresholds. In some arrangements, a flow threshold corresponding to the operational state of the system 1400 may be predetermined. In some arrangements, the flow threshold may be based at least in part on dynamic measurements or calculations of the system 1400 (such as flow rate or pressure) during a particular mode of the system (e.g., calibration mode).
Handle
Fig. 8A-8D illustrate another arrangement of handles 1208 that may be used with any of the embodiments of pump devices disclosed herein, including, for example, but not limited to, any arrangement of pump devices 160. In some arrangements, the handle 1208 may be configured to selectively change between at least a first state and a second state. Some arrangements of the handle 1208 may be more flexible in the first state than in the second state and/or may be stiffer or have a more firm feel in the second state than in the second state. In some arrangements, the handle 1208 may be configured to be changeable between a first state and a second state by flipping the handle 1208 over. For example, referring to fig. 8A-8B, an embodiment of the handle 1208 is shown in a first state in which the handle is more flexible. The same handle 1208 is shown in a second state in fig. 8C-8D, wherein the handle is stiffer or has a more firm feel.
Referring to fig. 8A-8D, the handle 1208 can have a base portion 1210 with a first opening 1212 and a second opening 1212 through end portions of the base portion 1210. The first and second openings 1212 may be used to couple the handle 1208 to the pump device using any suitable fasteners. However, in other arrangements, the handle 1208 may be coupled with the pump device using any suitable feature, including a reversible locking feature similar to a zipper strap, ratchet mechanism, or other quick-release connector. For example, the pump device may have a recessed feature that may be used to selectively release an end portion of the handle 1208 such that the handle may be removed and changed from a first state to a second state, or may be replaced with a second handle that is either more rigid or more flexible. As another example, some arrangements of the pump assembly 160 may have protrusions on the pump housing 210 that correspond to complementary features in the handle 208 such that the handle 208 may be separated and/or attached only when the handle 208 is in the fully forward position. When handle 208 is pulled out upright or extended to a fully rearward position, the protrusions may be configured to engage loops inside the handle attachment boss, which loops couple handle 208 with the protrusions while allowing handle 208 to freely rotate relative to housing 210.
The handle 1208 may also have a plurality of compression elements 1216 protruding away from the first surface 1218 of the base portion 1210. When the handle 1208 is in the first or flexible state, as shown in fig. 8A, the first surface 1218 can extend or face generally outwardly, and the compression element 1216 will also face generally outwardly (which can be radially outwardly in some arrangements). The compression elements 1216 may have a generally trapezoidal or tapered shape in some arrangements, and there may be spaces 1220 between each of the compression elements 1216, at least when the handle 1208 is in the first or flexible state. When the compression element 1216 is facing outward, as in the first state shown in fig. 8A, the curvature of the base portion 1210 may cause the space 1220 to expand or open such that the end portions of the compression element 1216 do not contact each other. When the compression elements 1216 face inwardly, as in the second state shown in fig. 8C, the curvature of the base portion 1210 may cause the end portions of the compression elements 1216 to eliminate the space between the compression elements 1216 and to contact and/or compress against each other, thereby causing the compression elements 1216 to increase the stiffness or rigidity of the handle 1208 and inhibit the flexibility of the handle 1208.
In other arrangements, the base portion 1210 may be made of stretchable fabric with compression elements (also referred to herein as spikes) each having a trapezoid or suitable shape protruding away from one of the major surfaces of the base portion, preferably wherein this would give the feel of a more flexible and strap-like strip in a flexible orientation, but remain rigid in the orientation where the trapezoid spikes meet. In any of the arrangements disclosed herein, the compression element may have any desired shape and is not limited to a trapezoidal shape. For example, but not limited to, the compression elements 1216 may have any suitable or desired shape with tapered surfaces between each element that allow the handle to be flexible when there is space between each of the compression elements 1216 and allow each of the compression elements 1216 to be more rigid when in contact with an adjacent compression element 1216.
Fig. 11A-11D illustrate an arrangement of a tank assembly 1600 that may be used with any of the pump assembly arrangements disclosed herein, including any of the pump assembly 160 disclosed herein. FIG. 11D is a cross-sectional view of tank assembly 1600 taken through line 11D-11D shown in FIG. 11C. Any arrangement of tank assemblies 1600 disclosed herein may have any component, feature, or other detail of any other tank assembly arrangement disclosed herein, including, but not limited to, any arrangement of the above-described tanks 162 in any combination with any component, feature, or detail of tank assemblies 1600 disclosed below. Similarly, any component, feature, or other detail of any other tank or tank assembly arrangement disclosed herein may have any component, feature, or other detail of any arrangement of tank assembly 1600 disclosed herein in any combination with any component, feature, or detail of a tank or tank assembly.
In any arrangement disclosed herein, the canister assembly 1600 may have a canister 1602, a conduit or tubing 1606 having a clip 1607 and connector 1608 at its distal end, a connector interface 1618, and a filter assembly 1620 housed within the canister 1600. The canister 1602 may have one or more, or a plurality of flanges 1627 (three flanges shown) configured to engage with or be engaged by latches, protrusions, or other selectively or non-selectively securable tabs or other features of the pump assembly (e.g., without limitation, latches 304, 306 and/or latch 282 of locking arms 266, 268 described above). The canister 1600 may have a first or upper portion 1602a and a second or lower portion 1602b, and may be any desired size, including 300mL (or about 300 mL), or 200mL (or about 200 mL) to 400mL (or about 400 mL). The first portion 1602a may be coupled with the second portion 1602 b. For example, but not limited to, the first portion 1602a may be welded, adhered, or otherwise secured with the second portion 1602 b. In other arrangements, the first portion 1602a may be integrally formed with the second portion 1602 b. The components of the can 1602 may be injection molded or formed by any other suitable method. The seal ring 1636 may be positioned around an outer surface of the connector interface 1618 (e.g., within an annular groove 1619 formed in the connector interface 1618). In some arrangements, the connector interface 1618 may be integrally formed with the first body portion 1602 a. A removable cap 1612 for the line connector 1608 may be tethered to the line 1606 near the line connector 1608.
In any arrangement disclosed herein, the canister assembly 1600 may also have a gelling agent 1622 (which may be in a package or bag) positioned within the interior space 1624 of the canister 1602, the gelling agent configured to increase the thickness or viscosity of a liquid within the interior space 1624, which may include wound exudate. In some arrangements, the gelling agent 1622 may be secured between a first protrusion 1630 extending away from the inner wall of the first portion 1602a toward the second portion 1602b and a second protrusion 1632 extending away from the inner wall of the second portion 1602b toward the first portion 1602 a. For example, the gelling agent 1622 may be pinched between the first and second protrusions 1630, 1632. In this arrangement, the first and second protrusions 1630, 1632 may be used to prevent movement of the gelling agent 1622 around the interior space 1624 of the canister 1602.
Referring to fig. 11D, the filter assembly 1620 may be used to filter out air that is transferred from the interior space 1624 of the canister 1602 to the pump assembly through the opening or passageway 1621 in the connector interface 1618, and may include a hydrophobic filter 1640, an odor filter 1642, and a dust collection filter 1644 that may be used to inhibit (e.g., prevent) dust or other particulates from passing through the pump assembly. The odor filter 1642 may also be configured to filter bacteria from air flowing through the filter assembly 1620. The hydrophobic filter 1640 may be used to prevent any liquid from escaping from the canister 1602 and contacting the odor filter 1642. The odor filter 1642 may comprise any suitable filter membrane or material, including carbon. For example, and without limitation, some arrangements of the odor filter 1642 may include compressed carbon. The filter assembly 1620 is also shown in fig. 12C and 12D. The first body portion 1602 may have one or more protrusions or brackets formed on an inner surface of the first body portion 1602 that are similar or identical to the protrusions 1765 formed on or positioned on the first body portion 1702 of the tank assembly 1700 shown in fig. 12D. The protrusions may serve to space the dust collection filter 1644 away from the planar surface inside the first body portion 1602a, 1702a and allow for greater air flow through the dust collection filter 1644.
In some arrangements, the filter 1642 may comprise a carbon activated foam material. In some arrangements, the filter 1642 may include a compressed carbon element as part of a filtration system in the canister. The carbon element may have various shapes and sizes depending on the canister. Carbon filters of different sizes and shapes may be employed to increase their effectiveness for different tank shapes. The filter assembly 1620 may optionally be positioned within a recess formed in the first body portion 1602a, such as a recess 1767 formed in the first body portion 1702a, as shown in fig. 12D.
The filter assembly 1620 may be supported at a lower or inner end by a base support 1650 that may be configured to provide a support surface for the hydrophobic filter 1640 and/or other components of the filter assembly 1620. Base support 1650 may have one or more openings 1652 through its major surface 1653 through which air and/or other gases may pass as they are pumped through filter assembly 1620 by the pump.
Some arrangements of the base support 1650 may optionally be configured to support one or more sensors and/or other electronic components. Referring to fig. 12C, some arrangements of base supports 1650 can have support surfaces 1654 configured to support sensors 1658 and/or other electronic components. For example, and without limitation, base support 1650 may have a support surface that is substantially parallel to a top surface of tank assembly 1600. In some arrangements, the base support 1650 may also have one or more support tabs 1655 (two shown) to provide additional support to one or more sensors and/or other electronic components. For example, the sensor may include a pair of electrodes configured to determine the fill level of the canister or detect whether the canister is fully responsive to detection of an electrical current between the electrodes via liquid (e.g., wound exudate) drawn into the canister. The support tab 1655 may support a pair of electrodes, which may be positioned on an outward facing side of the support tab 1655.
The support tab 1655 may extend away from the support surface 1654 toward the bottom of the can. The support tabs 1655 may have a flange or shield 1657 at the distal end of each of the support tabs 1655 to inhibit liquid (e.g., wound exudate) within the canister from splashing onto the support tabs 1655 and/or the electronic component 1658 (e.g., electrodes) and exposing to the gel pack 1622 or a stack of gelling agents. In some arrangements, the flanges 1657 may each extend at an angle away from the support tab 1655 (e.g., at a perpendicular angle). In other arrangements, the flange 1657 may extend at an angle greater than or less than 90 degrees relative to the support tab 1655.
In some arrangements, the electronic component 1658 may optionally be a fill level sensor or a canister fill sensor. The fill level sensor may have a wireless transmitter thereon (which may optionally be a near field communication transmitter) that may be configured to transmit status information (such as a detected fill level or whether the canister is full) to a wireless receiver or other in the pump assembly, or may have a wired connection through the canister in communication with the pump assembly.
The base support 1650 may have an annular flange 1660 around its perimeter and a recess 1662 that may be configured to receive and support at least the hydrophobic filter 1640. Optionally, the base support 1650 may be welded, adhered, or otherwise coupled within an inner surface of the first body portion 1602a of the body 1602 of the tank assembly 1600 prior to the first and second portions 1602a, 1602b of the body 1602 being coupled together.
Fig. 12A-12D illustrate another arrangement of tank assembly 160 that may be used with any of the pump assembly arrangements disclosed herein, including any of the pump assembly 1700 disclosed herein. Any arrangement of the tank assemblies 1700 disclosed herein may have any component, feature, or other detail of any other tank assembly arrangement disclosed herein, including, but not limited to, any arrangement of the above-described tanks 162 and/or tank assemblies 1600 in any combination with any component, feature, or detail of the tank assemblies 1700 disclosed below. Similarly, any component, feature, or other detail of any other tank or tank assembly arrangement disclosed herein may have any component, feature, or other detail of any arrangement of tank assembly 1700 disclosed herein in any combination with any component, feature, or detail of a tank or tank assembly.
As described above, in any arrangement disclosed herein, the canister assembly 1700 may have a canister 1702, a conduit or tubing 1606 having a connector 1608 at its distal end, a connector interface 1618, and a filter assembly 1620 housed within the canister 1700. The canister 1700 may have a first or upper portion 1702a and a second or lower portion 1702b, and may be any desired size, including 800mL (or about 800 mL), or 600mL (or about 600 mL) to 1000mL (or about 1000 mL). In any of the arrangements disclosed herein, the tank assembly 1700 may also have a gelling agent 1622 (which may be in a package or bag) positioned within the interior space 1724 of the tank 1702.
Referring to fig. 12D, the filter assembly 1620 of the arrangement of canister assemblies 1600, 1700 may include a hydrophobic filter 1640, an odor filter 1642 that may optionally be upstream of the hydrophobic filter 1640, and a dust collection filter 1644 that may optionally be upstream of the odor filter 1642 and may be used to inhibit (e.g., prevent) dust or other particulates from passing through the pump assembly. The filter assembly 1620 may be supported at a lower or inner end by a base support 1650 that may be configured to provide a support surface for the hydrophobic filter 1640 and/or other components of the filter assembly 1620. Optionally, base support 1650 may be welded, adhered, or otherwise coupled within an inner surface of first body portion 1702a of body 1702 of tank assembly 1700 before first and second portions 1702a, 1702b of body 1702 are coupled together.
Fig. 13A-13B illustrate another arrangement of a tank assembly 160 that may be used with any of the pump assembly arrangements disclosed herein, including any of the pump assembly 1800 disclosed herein. Fig. 14A-14B illustrate another arrangement of a tank assembly 160 that may be used with any of the pump assembly arrangements disclosed herein, including any of the pump assembly 1900 disclosed herein.
In any of the arrangements disclosed herein, any component, feature, or other detail of the tank assembly 1800 or 1900 may have any component, feature, or other detail of any other tank assembly arrangement disclosed herein, including, but not limited to, any arrangement of the tank 182 and tank assemblies 1600, 1700 described above in any combination with any component, feature, or detail of the tank assemblies 1800, 1900 disclosed below. Similarly, any component, feature, or other detail of any other tank or tank assembly arrangement disclosed herein may have any component, feature, or other detail of any arrangement of tank assemblies 1800, 1900 disclosed herein in any combination with any component, feature, or detail of a tank or tank assembly.
Some arrangements of the tank assembly 1900 may be identical to the tank assembly 1800, except for the size or volume of the tank assembly. The canister 1800 may have any desired size or volume, including 300mL (or about 300 mL), or 200mL (or about 200 mL) to 400mL (or about 400 mL). The tank 1900 may have any desired size or volume, including 800mL (or about 800 mL), or 600mL (or about 600 mL) to 1000mL (or about 1000 mL).
In any arrangement disclosed herein, the tank assemblies 1800, 1900 may have tanks 1802, 1902, respectively, a conduit or tubing 1606 having a clip 1607 and connector 1608 at a distal end thereof, a connector interface 1818, and a cap assembly 1820 that may be coupled with the tank 1800. The line 1606 may be coupled with a line connector 1609, which may be secured to the tanks 1802, 1902. The canister 1802 may be blow molded or formed by any desired or suitable method. The can assemblies 1800, 1900 may have a cap assembly 1820 that may have any of the components, features, or other details of any of the other cap assembly arrangements disclosed herein, including, but not limited to, any arrangement of the cap assemblies 360 described above in any combination with any of the components, features, or details of the cap assembly 1820 disclosed below. Similarly, any component, feature, or other detail of any other cap assembly arrangement disclosed herein may have any component, feature, or other detail of any arrangement of cap assembly 1820 disclosed herein in any combination with any component, feature, or detail of the cap assembly.
In some arrangements, the cap assembly 1820 may be configured to removably couple (e.g., without limitation, threadably couple) with an opening of the canister 1802, 1902 (such as 1903 shown in fig. 14C). In some arrangements, the cap assembly 1820 may be welded to the canister 1802, 1902 or otherwise non-removably coupled to the canister. Some arrangements of the cap assembly 1820 may include a cover or first cap member 1822 having a connector interface 1823 that may have an opening 1824 extending axially through a central portion of the first cap member 1822. The connector interface 1823 may protrude axially away from the first major surface of the first cap member 1822. The connector interface 1823 may have a generally cylindrical shape and an annular flange formed thereon that may be configured to receive a seal, such as an O-ring 1825. The opening 1824 may be configured to provide a fluid pathway for air and/or other gases within the canister 1802, 1902 to pass through and exit through the canister 1802, 1902.
The cap assembly 1820 may include an upper filter 1826 and an odor filter 1828. The upper filter 1826 may be a hydrophobic filter and/or a dust collection filter. Odor filter 1828 may also be configured to filter out bacteria from air flowing through filter 1828. The upper filter 1826 may be used to prevent any liquid from escaping from the canister 1802, 1902 through the opening 1824 in the first cap member 1822, and may be positioned on either or both sides of the odor filter 1828. Odor filter 1828 may include any suitable filter membrane or material, including carbon. For example, and without limitation, some arrangements of odor filter 1828 may include compressed carbon.
The cap assembly 1820 may also include a base cap support 1830, which may be configured to provide a support surface for one or more of the filters 1826, 1828 and/or other components of the cap assembly 1820. The base cap support 1830 is configured to block or shield the one or more filters 1826, 1828 from exudates and/or other liquids within the canister. In some arrangements, the base cap support 1830 may have a major surface 1840 that may overlap or cover at least a portion of the filter 1828 in order to inhibit or prevent liquid or exudates within the canister 1802, 1902 from splashing onto at least a portion of the odor filter 1828 and/or the upper filter 1826. For example, and without limitation, major surface 1840 may overlap at least 80% of the surface area of the lower major surface of odor filter 1828, or at least 90% of the surface area of the lower major surface of filter 1828, or at least 60% (or about 60%) to 90% (or about 90%) of the surface area of the first major surface of filter 1828.
The base cap support 1830 may have one or more openings 1844 formed therein through which air and/or other gases may pass as they are drawn through the cap assembly 1820 when the pump is in operation. The cap assembly 1820 may be configured such that all or substantially all of the air or gas from the canister 1802, 1902 must pass through the filter 1828 before passing through the opening 1844 in the cap assembly 1820. In some arrangements, there may be 3 or more, 4 or more, 5 or more openings 1844 formed in the base cap support 1830. The opening 1844 may be formed in a wall perpendicular to the top major surface of the canister 1802, 1902 such that exudates are less likely to splash or otherwise pass through the opening 1844, e.g., the opening 1844 may be formed in a vertical wall of the base cap support 1830.
In any arrangement disclosed herein, the canister assembly 1800, 1900 may also have a gelling agent (which may be in a package or bag) positioned within the interior space of the canister 1802, 1902, the gelling agent configured to increase the thickness or viscosity of a liquid within the interior space of the canister, which may include wound exudate.
Fig. 15A is a top, front and left perspective view of an arrangement of a device 2000 for applying negative pressure to a wound.
Fig. 15B is a front view of the arrangement of the device 2000 of fig. 15A.
Fig. 15C is a rear view of the arrangement of the device 2000 of fig. 15A.
Fig. 15D is a right side view of the arrangement of the device 2000 of fig. 15A.
Fig. 15E is a left side view of the arrangement of the device 2000 of fig. 15A.
Fig. 15F is a top view of the arrangement of the device 2000 of fig. 15A.
Fig. 15G is a bottom view of the arrangement of the device 2000 of fig. 15A.
Fig. 16A is a top, front and left perspective view of another arrangement of a device 2100 for applying negative pressure to a wound.
Fig. 16B is a front view of the arrangement of the device 2100 of fig. 16A.
Fig. 16C is a rear view of the arrangement of the device 2100 of fig. 16A.
Fig. 16D is a right side view of the arrangement of the device 2100 of fig. 16A.
Fig. 16E is a left side view of the arrangement of the device 2100 of fig. 16A.
Fig. 16F is a top view of the arrangement of the device 2100 of fig. 16A.
Fig. 16G is a bottom view of the arrangement of the device 2100 of fig. 16A.
Fig. 17A is a top, front and left perspective view of another arrangement of a device 2200 for applying negative pressure to a wound.
Fig. 17B is a front view of the arrangement of the device 2200 of fig. 17A.
Fig. 17C is a rear view of the arrangement of the device 2200 of fig. 17A.
Fig. 17D is a right side view of the arrangement of the device 2200 of fig. 17A.
Fig. 17E is a left side view of the arrangement of the device 2200 of fig. 17A.
Fig. 17F is a top view of an arrangement of the device 2200 of fig. 17A.
Fig. 17G is a bottom view of the arrangement of the device 2200 of fig. 17A.
Fig. 18A is a top, front and left perspective view of another arrangement of a device 2300 for applying negative pressure to a wound.
Fig. 18B is a front view of an arrangement of the device 2300 of fig. 18A.
Fig. 18C is a rear view of the arrangement of device 2300 of fig. 18A.
Fig. 18D is a right side view of the arrangement of device 2300 of fig. 18A.
Fig. 18E is a left side view of the arrangement of device 2300 of fig. 18A.
Fig. 18F is a top view of an arrangement of the device 2300 of fig. 18A.
Fig. 18G is a bottom view of the arrangement of device 2300 of fig. 18A.
In any of the arrangements 2000, 2100, 2200, 2300 shown and described herein, any solid line of such an arrangement may be a dashed line for representing features that are not part of the desired ornamental design. The scope of the present disclosure encompasses all lines illustrated, whether dashed or solid.
Other variants
Although some arrangements describe negative pressure wound therapy, the systems, devices, and/or methods disclosed herein may be applied to other types of therapy that may be used alone or in addition to TNP therapy. The systems, devices, and/or methods disclosed herein may be extended to any medical device, and in particular, to any wound treatment device. For example, the systems, devices, and/or methods disclosed herein may be used with devices that provide one or more of ultrasound therapy, oxygen therapy, nerve stimulation, microwave therapy, active agents, antibiotics, antimicrobial agents, and the like. In addition, such devices may provide TNP therapy. The systems and methods disclosed herein are not limited to medical devices and may be utilized by any electronic device.
Any of the data transmissions described herein may be securely performed. For example, one or more of encryption, https protocols, secure VPN connections, error checking, delivery acknowledgements, etc. may be utilized.
Any values of threshold, limit, duration, etc. provided herein are not intended to be absolute, and thus may be approximate. Additionally, any of the thresholds, limits, durations, etc. provided herein may be fixed or varied automatically or by a user. Moreover, relative terms such as above, greater than, less than, etc. as used herein with respect to a reference value are intended to also encompass equality to the reference value. For example, exceeding a positive reference value may encompass being equal to or greater than the reference value. In addition, relative terms such as above, greater than, less than, etc. as used herein with respect to a reference value are also intended to encompass the inverse of the disclosed relationship, such as lower than, less than, greater than, etc. with respect to the reference value.
Features, materials, characteristics, or groups described in connection with a particular aspect, arrangement, or example should be understood to apply to any other aspect, arrangement, or example described herein unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, unless at least some of such features and/or steps are mutually exclusive. The protection is not limited to the details of any of the foregoing arrangements. Protection extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.
Although certain arrangements have been described, these arrangements are presented by way of example only and are not intended to limit the scope of protection. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms. Moreover, various omissions, substitutions, and changes in the form of the methods and systems described herein may be made. Those skilled in the art will appreciate that in some arrangements, the actual steps taken in the illustrated and/or disclosed process may differ from those shown in the figures. Depending on the arrangement, some of the steps described above may be removed, and other steps may be added. For example, the actual steps taken in the disclosed processes and/or the order of steps may differ from those shown in the figures. Depending on the arrangement, some of the steps described above may be removed, and other steps may be added. For example, various components shown in the figures or described herein may be implemented as software and/or firmware on a processor, controller, ASIC, FPGA, and/or dedicated hardware. The software or firmware may include instructions stored in a non-transitory computer-readable memory. These instructions may be executed by a processor, controller, ASIC, FPGA, or dedicated hardware. Hardware components such as controllers, processors, ASICs, FPGAs, and the like may include logic circuitry. Moreover, the features and attributes of the specific arrangements disclosed above may be combined in different ways to form additional arrangements, all of which are within the scope of the present disclosure.
The user interface screens illustrated and described herein may include additional and/or alternative components. These components may include menus, lists, buttons, text boxes, labels, radio buttons, scroll bars, sliders, check boxes, combo boxes, status bars, dialog boxes, windows, and the like. The user interface screen may include additional and/or alternative information. The components may be arranged, grouped, and displayed in any suitable order.
Unless specifically stated otherwise, or otherwise understood in the context of use, conditional language such as "capable," "may," "might," "could," "for example," etc., as used herein is generally intended to convey that certain arrangements include certain features, elements and/or states, while other arrangements do not include certain features, elements and/or states. Thus, such conditional language is not generally intended to imply that features, elements and/or states are in any way required for one or more arrangements or that one or more arrangements must include logic for deciding, with or without author input or prompting, whether these features, elements and/or states are included in or are to be performed in any particular arrangement. The terms "comprising," "including," "having," and the like are synonymous and are used in an open-ended fashion, and do not exclude additional elements, features, acts, operations, etc. In addition, the term "or" is used in its inclusive sense (rather than its exclusive sense) such that, when used, for example, to connect a list of elements, the term "or" means one, some, or all of the elements in the list. Furthermore, the term "each" as used herein may refer to any subset of the set of elements to which the term "each" applies, except as may be otherwise indicated. In addition, as used in this disclosure, the words "herein," "above," "below," and words of similar import refer to this disclosure as a whole and not to any particular portions of this disclosure.
Unless specifically stated otherwise, a connection language such as the phrase "at least one of X, Y and Z" should be understood along with the commonly used context to express that an item, term, etc. may be X, Y or Z or a combination thereof. Thus, such connection language is not generally intended to imply that certain arrangements require at least one of X, at least one of Y, and at least one of Z to each be present.
The terms "about," "substantially," and "essentially" as used herein mean a value, quantity, or characteristic that is close to the specified value, quantity, or characteristic, yet still perform the desired function or achieve the desired result. For example, the terms "about," "substantially," and "substantially" may refer to amounts within less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of a specified amount. As another example, in certain arrangements, the terms "substantially parallel" and "substantially parallel" refer to a value, amount, or feature that deviates from exact parallelism by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, or 0.1 degrees.
Articles such as "a" or "an" should generally be construed to include one or more of the described items unless specifically stated otherwise. Thus, a phrase such as "a device configured as …" is intended to include one or more of the recited devices. Such one or more stated devices may also be collectively configured to perform the stated description.
Although the disclosure includes certain arrangements, examples, and applications, those skilled in the art will understand that the disclosure extends beyond the specifically disclosed arrangements to other alternative arrangements and/or uses and obvious modifications and equivalents thereof, including arrangements which do not provide all of the features and advantages set forth herein. Accordingly, the scope of the present disclosure is not intended to be limited by the specific disclosure of the preferred arrangements herein, and may be defined by the claims presented herein or set forth in the future.

Claims (41)

1. A negative pressure wound therapy device, comprising:
a negative pressure source comprising an inlet and an outlet, the negative pressure source configured to provide negative pressure to a wound covered by a wound dressing via a fluid flow path to aspirate fluid from the wound;
a first noise reduction chamber positioned in the fluid flow path downstream of the negative pressure source and in fluid communication with an outlet of the negative pressure source, the first noise reduction chamber configured to reduce noise generated as a result of aspirating fluid from the wound and/or to reduce pressure pulse levels in the fluid advancing through the negative pressure source, the first noise reduction chamber comprising an inlet and an outlet;
A second noise reduction chamber positioned in the fluid flow path downstream of the negative pressure source and in fluid communication with the outlet of the first noise reduction chamber, the second noise reduction chamber configured to reduce noise generated as a result of aspiration of fluid from the wound and/or to reduce pressure pulse levels in the fluid advancing through the negative pressure source and the first noise reduction chamber, the second noise reduction chamber comprising an inlet and an outlet;
wherein:
the second noise reduction chamber is spaced apart from the first noise reduction chamber; and is also provided with
The second noise reduction chamber is different from the first noise reduction chamber.
2. The apparatus of claim 1, wherein the first noise reduction chamber is configured to reduce noise generated by the negative pressure source and/or to reduce a pressure pulse level in the fluid advancing through the negative pressure source.
3. The device of any one of the preceding claims, further comprising a check valve positioned in the fluid flow path and configured to prevent fluid from flowing back in a reverse direction toward the negative pressure source.
4. The apparatus of claim 3, wherein the first noise reduction chamber is configured to reduce a pressure pulse level in the fluid advancing through the negative pressure source to reduce noise generated by the check valve.
5. The apparatus of any of claims 3-4, wherein the first noise reduction chamber is positioned upstream of the check valve and the second noise reduction chamber is positioned downstream of the check valve.
6. The apparatus of any of the preceding claims, wherein the second noise reduction chamber is positioned in series with and downstream of the first noise reduction chamber.
7. The apparatus of claim 2, wherein the second noise reduction chamber is closer to an exhaust of the apparatus than the first noise reduction chamber.
8. The apparatus of any of the preceding claims, further comprising foam positioned in at least one of the first noise reduction chamber and the second noise reduction chamber.
9. The device of any of the preceding claims, wherein the first noise reduction chamber comprises an inner wall that extends across a majority of a distance between a first wall of the first noise reduction chamber and a second wall adjacent or positioned opposite the first wall such that an opening is formed between an end of the inner wall and the second wall, the first noise reduction chamber configured to create a passageway between an inlet and an outlet of the first noise reduction chamber that requires the fluid passing through the first noise reduction chamber to pass through the opening formed between the end of an inner wall section and the second wall.
10. The device of any of the preceding claims, wherein the internal volume in the first noise reduction chamber and the second noise reduction chamber is greater than the volume within a first conduit in fluid communication with an inlet of at least one of the first noise reduction chamber or the second noise reduction chamber and greater than the volume within a second conduit in fluid communication with an outlet of at least one of the first noise reduction chamber or the second noise reduction chamber.
11. The apparatus of any one of the preceding claims, further comprising a flow module comprising one or more pressure sensors and solenoids.
12. The apparatus of any one of the preceding claims, wherein the negative pressure source comprises an electric motor, and wherein the apparatus further comprises a power source configured to power the electric motor.
13. The device of any one of the preceding claims, comprising a canister couplable with the device and configured to collect fluid aspirated from the wound as a result of negative pressure provided to the wound by the negative pressure source; and a cap coupled with the opening on the canister.
14. The device of claim 13, further comprising a filter coupled to or supported by the cap.
15. The apparatus of claim 14, wherein the filter comprises a carbon filter.
16. The device of any one of claims 13-15, further comprising a hydrophobic filter coupled to or supported by the cap.
17. A negative pressure wound therapy system, comprising:
a pump device comprising a negative pressure source configured to be fluidly connected to a wound covered by a wound dressing;
a canister coupleable with the pump device and configured to collect fluid aspirated from a wound as a result of negative pressure provided to the wound by the negative pressure source; and
a canister release mechanism coupled with the pump device and including an actuator coupled with one or more movable latches, the canister release mechanism configured to disengage the pump device from the canister when the actuator is depressed;
wherein:
one or more latches are configured to move between a first position in which they secure the canister to the pump device and a second position in which they release the canister from the pump device when the actuator is depressed.
18. The system of claim 17, comprising a cap coupleable with an opening on the canister.
19. The system of any one of claims 18-19, comprising a filter positioned within or supported by the cap.
20. The system of claim 19, wherein the cap comprises a surface configured to overlap at least a portion of the filter so as to inhibit exudate within the canister from splashing onto at least a portion of the filter, the shield overlapping at least 80% of a surface area of the first major surface of the filter.
21. The system of any of claims 17-20, wherein the one or more latches are configured to engage a cap coupled with the canister in the first position and release the cap coupled with the canister in the second position.
22. The system of any of claims 17-21, wherein the canister release mechanism is configured to release the canister from the pump device by pressing only a single button.
23. The system of claim 22, wherein the single button is supported by an outer surface of a housing of the pump device.
24. The system of any of claims 17-23, wherein the canister release mechanism is configured to release the canister from the pump device with only one-handed operation.
25. The system of any of claims 17-24, wherein the canister release mechanism comprises a button, and wherein the actuator is configured to move the one or more latches from the first position to the second position when the button is pressed.
26. The system of claim 25, wherein the button is supported by an outer surface of a housing of the device.
27. The system of any of claims 17-26, wherein the canister release mechanism is configured to move the canister away from the pump assembly when the canister release mechanism is actuated.
28. The system of any of claims 17-27, wherein the canister release mechanism includes at least one tab configured to push the canister away from the pump device when the canister release mechanism is actuated.
29. The system of any one of claims 17-28, wherein the pump device comprises a power cord electrically connected to a panel, the panel being removable from the exterior of the housing of the pump device without removing or opening the housing, such that the power cord can be replaced by replacing the panel that is removable from the exterior of the housing of the pump device.
30. The system of any of claims 17-29, wherein the user interface of the pump device is located on an upper surface of the pump device, the upper surface oriented at an angle within 35 ° from horizontal.
31. The system of any one of claims 17-30, wherein the pump device has one or more conduit supports removably coupled with a housing of the pump device, wherein a conduit of the pump device extends through a closed opening of the one or more conduit supports, and the one or more conduit supports have at least one additional opening in which the conduit is removably supportable.
32. A negative pressure wound therapy system, comprising:
a device comprising a negative pressure pump actuated by a pump motor, a battery, a display, a lower core assembly, and an upper support within a housing;
a canister coupleable with the device and configured to collect fluid aspirated from a wound covered by a wound dressing as a result of negative pressure provided by the negative pressure pump to the wound; and
a cap coupled with an opening on the canister;
wherein:
the lower core assembly is configured to receive and support at least the pump motor and the battery;
The upper support is coupled with the lower core assembly, the upper support extending above the lower core assembly;
the upper support is configured to receive and support at least a display of the pump assembly; and is also provided with
The display can be removed from the pump assembly by removing the housing and by removing the upper support from the pump assembly.
33. The system of claim 32, comprising a filter coupled to or supported by the cap.
34. The apparatus of claim 33, wherein the filter comprises a carbon filter.
35. The system of any one of claims 32-34, further comprising a hydrophobic filter coupled to or supported by the cap.
36. The system of any of claims 32-35, wherein the cap further comprises a shield configured to overlap at least a portion of the filter so as to inhibit exudate within the canister from splashing onto at least a portion of the filter, the shield overlapping at least 40% of a surface area of the first major surface of the filter.
37. The system of any of claims 32-36, further comprising a canister release mechanism.
38. The system of any of claims 32-37, wherein the canister release mechanism comprises one or more latches configured to move between a first position in which the one or more latches secure the canister to the device and a second position in which the one or more latches release the canister from the device.
39. A kit comprising a device according to any one of the preceding claims, and a wound dressing.
40. A method of operating any of the apparatus of any of the preceding claims.
41. An apparatus, system and/or method as shown and/or described.
CN202280016895.0A 2021-03-23 2022-03-23 Negative pressure wound treatment device Pending CN116981489A (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
GB2104021.7 2021-03-23
GBGB2116401.7A GB202116401D0 (en) 2021-11-15 2021-11-15 Negative pressure wound therapy devices
GB2116401.7 2021-11-15
PCT/EP2022/057668 WO2022200453A1 (en) 2021-03-23 2022-03-23 Negative pressure wound therapy devices

Publications (1)

Publication Number Publication Date
CN116981489A true CN116981489A (en) 2023-10-31

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Application Number Title Priority Date Filing Date
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GB (1) GB202116401D0 (en)

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