Negative Pressure Wound Therapy Device
Patent Information
- Application Number
- JP2023553200
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2021-11-15
- Filing Date
- 2022-03-23
- Publication Date
- 2025-02-21
- Estimated Expiration
- 2042-03-23
AI Technical Summary
Existing negative pressure wound therapy systems face challenges in efficiently managing canister attachment and detachment, noise reduction, and odor control, which can disrupt patient comfort and wound healing.
The system incorporates a one-handed canister release mechanism, dual noise reduction chambers, and an integrated odor filter within the canister to address these issues, enhancing user convenience and therapeutic efficacy.
The improved design facilitates easy canister replacement, reduces operational noise, and minimizes odor, thereby promoting patient comfort and effective wound healing.
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Abstract
Description
[Technical field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to UK Provisional Patent Application No. 2104021.7, filed March 23, 2021, and UK Provisional Patent Application No. 2116401.7, filed November 15, 2021, each of which is incorporated by reference in its entirety as if fully set forth herein. The benefit of priority may be claimed under any appropriate legal basis, including, but not limited to, 35 U.S.C. § 119(e).
[0002] The arrangements described herein relate to devices, systems, and methods for the treatment of wounds, for example devices, systems, and methods that include a negative pressure source for use with negative pressure wound therapy dressings. [Background technology]
[0003] 2. Description of Related Art Many different kinds of wound dressings are known to aid in the healing process of humans or animals. These different types of wound dressings include different types of materials and layers, such as gauze, pads, foam pads, or multi-layer wound dressings. Topical negative pressure (TNP) therapy, sometimes referred to as vacuum-assisted closure therapy, negative pressure wound therapy, or reduced pressure wound therapy, is widely recognized as a beneficial mechanism for improving wound healing rates. Such therapy is applicable to a wide range of wounds, such as surgical wounds, open wounds, and abdominal wounds. TNP therapy can reduce tissue edema, promote blood flow, stimulate the formation of granulation tissue, and aid in wound closure and healing by removing excess exudate, and reduce bacterial load. Thus, reducing infection in the wound. Moreover, TNP therapy reduces external disturbances to the wound, promoting faster healing.
[0004] Overview of some example configurations The systems, methods, and devices of the present disclosure each have several innovative aspects, implementations, or aspects, no single one of which is solely responsible for the desirable attributes disclosed herein.
[0005] Disclosed herein are arrangements of negative pressure wound therapy systems that may include one or more of a pump assembly including 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 drawn from the wound as a result of negative pressure being provided to the wound by the negative pressure source, and a canister release mechanism coupled to the pump assembly and including an actuator coupled to one or more movable latches, the canister release mechanism configured to cause the pump assembly to disengage the canister from the pump assembly. 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 pressed.
[0006] Any of the arrangements of the negative pressure wound therapy devices, systems, and methods of using the negative pressure wound therapy devices and components of the negative pressure wound therapy devices disclosed herein, in any combination with any of the other steps, functions, components, and / or details of the other arrangements disclosed herein, may include one or more of the following steps, features, components, and / or details in additional arrangements: a cap connectable with the opening on the canister; a filter positioned within or supported by the cap; the cap includes a shield configured to overlap at least a portion of the filter to inhibit exudate within the canister from splashing onto at least a portion of the filter; the shield overlaps at least 40% of a surface area of a first major surface of the filter; one or more latches configured to engage the cap connected with the canister in a first position and release the cap connected with the canister in a second position; a canister release mechanism for connecting the canister to the pump assembly; a canister release mechanism configured to release the canister from the pump assembly with only a push of a single button, the single button being supported by an exterior surface of a housing of the pump assembly, the canister release mechanism configured to release the canister from the pump assembly with only a one handed operation, the canister release mechanism including a button, and an actuator configured to move the one or more latches from a first position to a second position when the button is pressed, the button being supported by an exterior surface of a housing of the device, the canister release mechanism configured to move the canister away from the pump assembly when the canister release mechanism is activated, the canister release mechanism including at least one protrusion configured to push the canister away from the pump assembly when the canister release mechanism is activated, the pump assembly being operable without removing or opening the housing such that the power socket and / or power cord may be replaced by replacing a panel that may be removed from outside the housing of the pump assembly,a power cord electrically connected to a panel that can be removed from the exterior of the housing of the pump assembly, and a user interface for the pump assembly is located on a top surface of the pump apparatus that is oriented at an angle of no more than 35° of the horizontal, and / or the pump apparatus has one or more tube supports that are removably coupled to the housing of the pump apparatus, the tubes of the pump apparatus extending through enclosed openings in the one or more tube supports, the one or more tube supports having at least one additional opening in which the tubes can be removably supported;
[0007] Also disclosed herein are arrangements of a negative pressure wound therapy system that may include one or more of the devices including a negative pressure pump operated by a pump motor, a battery, a display, a lower core assembly, and an upper support within a housing, a canister that is connectable with the device and configured to collect fluid drawn from the wound as a result of the negative pressure being provided by the negative pressure pump to the wound covered by the wound dressing, and a cap that connects with an opening on the canister. In any arrangement 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 connected to the lower core assembly, and the upper support extends over the lower core assembly. Further, in some arrangements, the upper support may be configured to receive and support at least the display of the pump assembly, and the display may be removed from the pump assembly by removing the housing and removing the upper support from the pump assembly.
[0008] Arrangements of negative pressure wound therapy systems and methods of using the negative pressure wound therapy systems and components of negative pressure wound therapy systems disclosed herein, in any combination with any of the other steps, functions, components and / or details of other arrangements disclosed herein, may include one or more of the following steps, features, components and / or details in additional arrangements: further including a filter coupled to or supported by the cap, the filter including a carbon filter, and further including a hydrophobic filter coupled to or supported by the cap; the cap including a shield configured to overlap at least a portion of the filter to inhibit exudate in 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 a surface area of a first major surface of the filter; and further including a canister release mechanism, the canister release mechanism including 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.
[0009] Disclosed herein are arrangements 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, configured to provide negative pressure to a wound covered by a wound dressing via a fluid flow path to draw fluid from the wound, a first noise reduction chamber positioned in the fluid flow path downstream of the negative pressure source and capable of fluid communication with the outlet of the negative pressure source, and a second noise reduction chamber downstream of the negative pressure source and in fluid communication with the 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 a level of pressure pulses in a 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 a level of pressure pulses in a 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.
[0010] Also disclosed herein are arrangements of negative pressure wound therapy devices. In some arrangements, the negative pressure wound therapy device can 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 to draw fluid from the wound via a fluid flow path. The negative pressure wound therapy device can include a first noise reduction chamber positioned in the fluid flow path downstream of the negative pressure source and can be in fluid communication with an outlet of the negative pressure source. The first noise reduction chamber can include an inlet and an outlet and can be configured to reduce noise generated as a result of the drawing of fluid from the wound. The negative pressure wound therapy device can also 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 can include an inlet and an outlet and can be configured to reduce noise generated as a result of the drawing of fluid from the wound. In some arrangements, the second noise reduction chamber can be spaced apart from the first noise reduction chamber and can be different from the first noise reduction chamber. Additionally, a second noise reduction chamber can be positioned in series with and downstream of the first noise reduction chamber, and in some arrangements the second noise reduction chamber can be closer to the exhaust of the apparatus than the first noise reduction chamber.
[0011] The negative pressure wound therapy device arrangements, systems, and methods of using the negative pressure wound therapy devices and components of the 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 of the other steps, functions, components, and / or details of the other arrangements disclosed herein, in additional arrangements, where the negative pressure wound therapy device further includes a foam positioned in at least one of the first and second noise reduction chambers, the first noise reduction chamber includes an inner wall extending across a majority of the distance between the first and second walls of the first noise reduction chamber positioned adjacent to or 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 is configured to form a passageway between an inlet and an outlet of the first noise reduction chamber that requires fluid passing through the first noise reduction chamber to pass through an opening formed between an end of the inner wall segment and the second wall, and the interior volumes of the first and second noise reduction chambers are a flow module including one or more pressure sensors, the flow module including a flow manifold ...or a hydrophobic filter supported thereon.
[0012] In some arrangements, the 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 the 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 electrodes positioned on a support extending into an interior of the canister housing, the electrodes configured to be in fluid communication with fluid aspirated from the wound. The support may include a flange configured to prevent fluid from splashing onto the electrodes 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 electrodes. The fluid level sensor may be configured to detect a full condition of the canister when the electrical circuit is completed. The canister may include electronic circuitry configured to communicate (eg, wirelessly) a condition of the canister detected by the fluid level sensor.
[0013] Also disclosed are method arrangements of operating any of the devices of the preceding paragraphs, and / or any arrangement of the systems or devices disclosed herein, as well as kit arrangements including the devices of any of the preceding claims, and wound dressings.
[0014] Any feature, component, or detail of the arrangement or any of the arrangements disclosed in the present application, including but not limited to any of the device arrangements and any of the negative pressure wound therapy arrangements disclosed herein, may be interchangeably combined with any other feature, component, or detail of the arrangement or any of the arrangements disclosed herein to form new arrangements and configurations. [Brief description of the drawings]
[0015] [Figure 1A] FIG. 1A illustrates a negative pressure wound therapy system. [Figure 1B] FIG. 1B illustrates another negative pressure wound therapy system. [Figure 2A] FIG. 2A is an isometric view of a negative pressure wound therapy device having a pump assembly and a canister. [Figure 2B] FIG. 2B is a front view of the negative pressure wound therapy device shown in FIG. 2A. [Figure 2C] FIG. 2C is a rear view of the negative pressure wound therapy device shown in FIG. 2A. [Figure 2D] FIG. 2D is a side view of the negative pressure wound therapy device shown in FIG. 2A. [Figure 2E] FIG. 2E is a rear and bottom isometric view of the negative pressure wound therapy device shown in FIG. 2A. [Figure 2F] FIG. 2F is a top view of the negative pressure wound therapy device shown in FIG. 2A. [Figure 2G] FIG. 2G is a cross-sectional view of the negative pressure wound therapy device shown in FIG. 2A taken through line 2G-2G of FIG. 2F. [Figure 2H] FIG. 2H is an isometric view of the negative pressure wound therapy device shown in FIG. 2A, showing the canister removed from the pump assembly. [Figure 2I] FIG. 2I shows the top surface of the negative pressure wound therapy device shown in FIG. 2A, illustrating the user interface. [Figure 3A] FIG. 3A shows an exploded view of the pump assembly of the negative pressure wound therapy device shown in FIG. 2A. [Figure 3B]FIG. 3B shows the canister of the negative pressure wound therapy device shown in FIG. 2A. [Figure 3C] 3C, 3D, 3E, and 3F show partially exploded views of a portion of the pump assembly shown in FIG. 3A. [Figure 3D] Same as above. [Figure 3E] Same as above. [Figure 3F] Ibid. Figures 3G, 3H, 3I, 3J, and 3K show a portion of an alternative configuration of the pump assembly. [Figure 4A] 4A, 4B, 4C, 4D, 4E, 4F, 4G, and 4H show the lower core assembly of the pump assembly shown in FIG. 3A. [Figure 4B] Same as above. [Figure 4C] Same as above. [Figure 4D] Same as above. [Figure 4E] Same as above. [Figure 4F] Same as above. [Figure 4G] Same as above. [Figure 4H] Same as above. [Figure 5A] Figures 5A, 5B, 5C, 5D and 5E show a cap assembly for the canister shown in Figure 3B. [Figure 5B] Same as above. [Figure 5C] Same as above. [Figure 5D] Same as above. [Figure 5E] Same as above. [Figure 6A] 6A, 6B, 6C, 6D, 6E, and 6F show filter variations that can be used with any of the negative pressure wound therapy devices disclosed herein. [Figure 6B] Same as above. [Figure 6C] Same as above. [Figure 6D] Same as above. [Figure 6E] Same as above. [Figure 6F] Same as above. [Figure 7A]FIG. 7A shows a tube support for the negative pressure wound therapy device shown in FIG. 2A. [Figure 7B] FIG. 7B shows a portion of the pump assembly shown in FIG. 2A. [Figure 8A] 8A, 8B, 8C, and 8D show variations of handles that can be used with any of the negative pressure wound therapy devices disclosed herein. [Figure 8B] Same as above. [Figure 8C] Same as above. [Figure 8D] Same as above. [Figure 9] FIG. 9 illustrates a schematic diagram of a control system for a negative pressure wound therapy device. [Figure 10] FIG. 10 illustrates another negative pressure wound therapy system. [Figure 11A] 11A, 11B, 11C, and 11D show canister assembly configurations that can be used with any of the pump assembly configurations disclosed herein. [Figure 11B] Same as above. [Figure 11C] Same as above. [Figure 11D] Same as above. [Figure 12A] 12A, 12B, 12C, and 12D show alternative arrangements of a canister assembly that can be used with any of the pump assembly arrangements disclosed herein. [Figure 12B] Same as above. [Figure 12C] Same as above. [Figure 12D] Same as above. [Figure 13A] 13A and 13B show another arrangement of a canister assembly that can be used with any of the pump assembly arrangements disclosed herein. [Figure 13B] Same as above. [Figure 14A] 14A, 14B, 14C, and 14D show alternative arrangements of a canister assembly that can be used with any of the pump assembly arrangements disclosed herein. [Figure 14B]Same as above. [Figure 14C] Same as above. [Figure 14D] Same as above. [Figure 15A] FIG. 15A is a top, front, and left side perspective view of an arrangement of devices for applying negative pressure to a wound. [Figure 15B] FIG. 15B is a front view of the device arrangement of FIG. 15A. [Figure 15C] FIG. 15C is a rear view of the device arrangement of FIG. 15A. [Figure 15D] FIG. 15D is a right side view of the device arrangement of FIG. 15A. [Figure 15E] FIG. 15E is a left side view of the device arrangement of FIG. 15A. [Figure 15F] FIG. 15F is a top view of the device arrangement of FIG. 15A. [Figure 15G] FIG. 15G is a bottom view of the device arrangement of FIG. 15A. [Figure 16A] FIG. 16A is a top, front, and left side perspective view of another arrangement of an apparatus for applying negative pressure to a wound. [Figure 16B] FIG. 16B is a front view of the device arrangement of FIG. 16A. [Figure 16C] FIG. 16C is a rear view of the device arrangement of FIG. 16A. [Figure 16D] FIG. 16D is a right side view of the device arrangement of FIG. 16A. [Figure 16E] FIG. 16E is a left side view of the device arrangement of FIG. 16A. [Figure 16F] FIG. 16F is a top view of the device arrangement of FIG. 16A. [Figure 16G] FIG. 16G is a bottom view of the device arrangement of FIG. 16A. [Figure 17A] FIG. 17A is a top, front, and left side perspective view of another arrangement of an apparatus for applying negative pressure to a wound. [Figure 17B] FIG. 17B is a front view of the device arrangement of FIG. 17A. [Figure 17C] FIG. 17C is a rear view of the device arrangement of FIG. 17A. [Figure 17D] FIG. 17D is a right side view of the device arrangement of FIG. 17A. [Figure 17E] FIG. 17E is a left side view of the device arrangement of FIG. 17A. [Figure 17F] FIG. 17F is a top view of the device arrangement of FIG. 17A. [Figure 17G] FIG. 17G is a bottom view of the device arrangement of FIG. 17A. [Figure 18A] FIG. 18A is a top, front, and left side perspective view of another arrangement of an apparatus for applying negative pressure to a wound. [Figure 18B] FIG. 18B is a front view of the device arrangement of FIG. 18A. [Figure 18C] FIG. 18C is a rear view of the device arrangement of FIG. 18A. [Figure 18D] FIG. 18D is a right side view of the device arrangement of FIG. 18A. [Figure 18E] FIG. 18E is a left side view of the device arrangement of FIG. 18A. [Figure 18F] FIG. 18F is a top view of the device arrangement of FIG. 18A. [Figure 18G] FIG. 18G is a bottom view of the device arrangement of FIG. 18A. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0016] Configurations disclosed herein relate to systems and methods for treating and / or monitoring wounds. Some configurations of the negative pressure wound therapy devices disclosed herein may include a negative pressure source connected and / or fluidly coupled via a fluid flow path to a wound covered by a wound dressing and configured to provide negative pressure to the wound.
[0017] Throughout this specification, reference is made to wounds. The term wound is broadly interpreted to include open and closed wounds where the skin is torn, incised, or perforated, or where trauma causes bruising, or any other surface or other pathology or incompleteness in the skin of a patient, or others that would benefit from reduced pressure treatment. Thus, a wound is broadly defined as any damaged area of tissue where fluid may or may not be produced. Examples of such wounds include, but are not limited to, abdominal wounds or other large wounds or incisions, abdominal wounds with open viscera, abdominal compartment syndrome, burns, partial thickness burns resulting from any of surgery, trauma, sternotomy, fasciotomy, or other conditions, dehiscence wounds, acute wounds, subacute wounds, chronic wounds, subacute and dehiscence wounds, traumatic wounds, skin flaps and skin grafts, lacerations, abrasions, contusions, bruises, diabetic ulcers, bedsores, stomas, surgical wounds, trauma, and venous ulcers.
[0018] The configurations of the systems and methods disclosed herein can be used with topical negative pressure ("TNP") or reduced pressure therapy systems. Simply put, negative pressure wound therapy can assist in the closure and healing of many forms of "hard to heal" wounds by reducing tissue edema, encouraging blood flow and granular tissue formation, and removing excess exudate, reducing bacterial load (and therefore infection risk). Furthermore, this therapy can lead to less wound injury and more rapid healing. TNP therapy systems can also assist in the healing of surgically closed wounds by removing fluids. TNP therapy can help stabilize tissues in opposition to closure. Further beneficial uses of TNP therapy can be found in grafts and flaps, where removing excess fluid is important and grafts are required to be in close proximity to tissue to ensure tissue viability.
[0019] As used herein, a reduced pressure or negative pressure level, such as -XmmHg, represents a pressure level relative to normal ambient atmospheric pressure, which may correspond to 760mmHg (or 1 atm, 29.93 inHg, 101.325 kPa, 14.696 psi, etc.). Thus, a negative pressure value of -XmmHg reflects a pressure that is XmmHg lower than 760mmHg, or in other words, a pressure of (760-X)mmHg. Additionally, a negative pressure that is "lower" or "less" than XmmHg corresponds to a pressure that is closer to atmospheric pressure (e.g., -40mmHg is lower than -60mmHg). A negative pressure that is "higher" or "greater" than -XmmHg corresponds to a pressure that is further from atmospheric pressure (e.g., -80mmHg is higher than -60mmHg). In some cases, the local ambient atmospheric pressure is used as a reference point, and such local atmospheric pressure may not necessarily be, for example, 760 mmHg.
[0020] The systems and methods disclosed herein may be used in addition to or in place of other types of treatments, such as irrigation, removal of irrigation fluids, reduced pressure therapy, such as ultrasound, heating or cooling, neurostimulation, or 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 with dressings, including compression dressings, reduced pressure dressings, or the like.
[0021] A medical professional, such as a doctor, nurse, or the like, can provide a TNP prescription that specifies, for example, pressure levels or application times. However, the healing process varies from patient to patient, and the prescription may affect the healing process in ways that the clinician or medical provider did not anticipate when devising the prescription. The medical provider may attempt to adjust the prescription as the wound heals (or does not heal), but such a process may require various appointments that may be time-consuming and repetitive. The arrangements disclosed herein provide a system, device, or method for efficiently adjusting the TNP prescription and delivering an effective TNP therapy.
[0022] Wound Therapy Systems Any implementation 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 assembly may include a printed circuit board assembly (PCBA), which may be an electronic assembly that may include two system microcontrollers. The PCBA may include a main controller that may control one or more operations of the user interface, communication interface, and alarm generation. The PCBA may include a motor controller (sometimes referred to as a pump controller), which may control one or more operations of the pump or monitor other signals such as temperature, pump voltage / current, etc. Any implementation of the system disclosed herein may have two microcontrollers that provide some redundancy to the system. In this arrangement, if one controller fails, the other controller can respond and ensure that the system has safely failed. The two microcontrollers may share periodic communication to ensure that the other is still functioning. In any arrangement, the core assembly may include a display, which may be one or more of a color display or a touch screen.
[0023] Any implementation of the core assembly may include a flow module (or flow manifold). In some arrangements, the flow module may include a two-piece housing that forms the internal passageway when assembled. The flow module may be constructed to integrate the canister connection, pressure sensor, self-test solenoid valve, and check valve with minimal external tubing. This reduces the chance of the internal tubing 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 valve of the flow module. The pressure sensors may allow for airflow measurement by measuring the pressure drop across the solenoid valve. A check valve may be used to stop any rear leakage due to wear of the motor barre.
[0024] In some arrangements, plastic moldings are used for the core module or core assembly construction. Each module in the pump assembly may be supported by a separate plastic molding such that each module may be supported entirely on a separate plastic molding.
[0025] 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-loaded mechanism that can selectively engage or secure to a canister cap that may be threaded with the canister or otherwise coupled with the canister (e.g., welded, glued, etc.). A canister release button may be used to unlock the locking mechanism and remove the canister. Some arrangements of the canister lock / unlock mechanism may be configured for one-handed operation to aid a user with only one hand or one strong hand in removing the canister from the pump assembly. For example, and without limitation, the canister locking mechanism is unlocked so that the canister may be removed from the pump assembly by pressing the canister release button. The negative pressure wound treatment system 100 may be configured to unlock the canister locking mechanism, which in some arrangements causes the pump assembly to apply a force to the canister, physically separating the canister from the pump assembly. In other arrangements, the negative pressure wound treatment system 100 may be configured to allow the user to remove the canister from the pump assembly using only one hand (i.e., one-handed operation). Again, some arrangements of the negative pressure wound treatment 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 one finger. In some arrangements, the use of this locking mechanism is beneficial because, while making the pump unit slightly more complex, the locking mechanism allows for a simpler canister design (no separate clip) and provides a good user experience. The lower core assembly or support may provide support for the battery, pump, and flow module. The core upper component may support the PCBA and display.
[0026] FIG. 1A illustrates a schematic of a negative pressure wound treatment system 100 (also referred to as a reduced pressure or negative pressure wound therapy system, TNP system, or wound treatment system). Although not required in any implementation disclosed herein, the negative pressure wound treatment system 100 may include a wound packing 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 wound packing 102 in combination with the 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 to a wound therapy device 110 (which may be referred to in whole or in part as a "pump assembly") configured to provide reduced pressure or negative pressure. The conduit 108 may be a single inner lumen tube or a multi-lumen tube. A connector 112 may be used to removably and selectively connect the conduit or tube 142 to the conduit 108.
[0027] In any of the systems disclosed herein, the wound therapy device may be canister-less, for example and without limitation, wound exudate is collected in a wound dressing or transferred via a conduit for collection elsewhere, however, any of the wound therapy devices disclosed herein may include or support a canister.
[0028] Additionally, in any of the wound therapy systems disclosed herein, any of the wound therapy devices may be attached to or supported by a wound dressing or adjacent to a wound dressing. The wound filler 102 may be of any suitable type, such as hydrophilic or hydrophobic foam, gauze, an inflatable bag, or the like. The wound filler 102 may be conformable to the wound 104 such that the wound filler 102 substantially fills the cavity of the wound 104. The wound cover 106 may provide a substantially fluid-impermeable seal over the wound 104. The wound cover 106 may have a top side and a bottom side. The bottom side may be adhesively (or in any other suitable manner) sealed to the wound 104, for example, by sealing with the skin around the wound 104. The conduit 108 or any other conduit disclosed herein may be formed from polyurethane, PVC, nylon, polyethylene, silicone, or any other suitable material.
[0029] The wound cover 106 may have a port (not shown) configured to receive an end of the conduit 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 to maintain a desired level of reduced pressure within the wound 104. The conduit 108 may be any suitable article configured to provide at least a substantially sealed fluid flow path or passage between the wound therapy device 110 and the wound cover 106 to supply reduced pressure provided by the wound therapy device 110 to the wound 104.
[0030] The wound cover 106 and wound packing 102 may be provided as a single item or integral single unit. In some cases, no wound packing is provided and the wound cover itself may be considered the wound dressing. The wound dressing may then be connected to a negative pressure source of the wound therapy device 110 via a conduit 108. In some cases, although not required, the wound therapy device 110 may be miniaturized and portable, although a larger conventional negative pressure source (or pump) may also be used.
[0031] The wound cover 106 may be placed over the wound site to be treated. The wound cover 106 may form a substantially sealed cavity or enclosed space over the wound. The wound cover 106 may have a film with high water vapor permeability to allow evaporation of excess fluids, and may have a superabsorbent material contained therein to safely absorb wound exudate. In some cases, the components of the TNP system described herein may be particularly suitable for incisional wounds that exude a small amount of wound exudate.
[0032] The wound therapy device 110 can be operated with or without the use of an exudate canister. In some cases, as illustrated, the wound therapy device 110 may include an exudate canister. In some cases, configuring the wound therapy device 110 and the conduit 108 such that the conduit 108 can be quickly and easily removed from the wound therapy device 110 can facilitate or improve the process of changing wound dressings or pumps, if necessary. Any of the pump assemblies disclosed herein may have any suitable connection between the conduit 108 and the pump.
[0033] The wound therapy device 110 may deliver a negative pressure of approximately -80 mmHg, or between about -20 mmHg and -200 mmHg. Note that these pressures are relative to normal ambient atmospheric pressure, i.e., -200 mmHg may actually be about 560 mmHg. In some cases, the pressure range may be between about -40 mmHg and -150 mmHg. Alternatively, a pressure range of -75 mmHg or less, -80 mmHg or less, or greater than -80 mmHg may be used. Also, in some cases, a pressure range below -75 mmHg may be used. Alternatively, a pressure range of approximately -100 mmHg, or even greater than -150 mmHg may be provided by the wound therapy device 110.
[0034] As described in more 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'. The connection 332' may be wired or wireless (such as Bluetooth, Bluetooth Low Energy (BLE), Near Field Communication (NFC), WiFi, or cellular). The remote computing device 334' may be a smartphone, tablet, laptop or another standalone computer, a server (such as a cloud server), another pump device, or the like.
[0035] FIG. 1B illustrates another negative pressure wound treatment system 100. The negative pressure wound treatment system 100 may have any of the components, features, or other details of any of the other negative pressure wound treatment systems disclosed herein, including but not limited to the negative pressure wound treatment system 100′ shown in FIG. 1A or the negative pressure wound treatment 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 treatment system 100′ shown in FIG. 1B and / or described herein. The negative pressure wound treatment system 100 may have a wound cover 106 over the wound 104 that may seal the wound 104. A conduit 108, such as a single lumen or multi-lumen tubing, may be used to connect the wound cover 106 with a wound therapy device 110 (sometimes referred to as a “pump assembly” in whole or in part) configured to deliver reduced pressure or negative pressure. The wound cover 106 may be in fluid communication with the wound 104.
[0036] 1B, the conduit 108 may have a bridge portion 130, which may have a proximal end and a distal end (the distal end being closer to the wound 104 than the proximal end), and an applicator 132 at the distal end of the bridge portion 130, which forms a flexible suction adapter (or conduit) 108. A connector 134 may be disposed at the proximal end of the bridge portion 130 to extend along the length of the bridge portion 130 of the conduit 108 shown in FIG. 1B and connect to at least one of the channels. A cap 140 may be coupled to a portion of the conduit 108, and in some cases may be attached to the connector 134, as illustrated. The cap 140 may be useful in preventing fluid from leaking out the proximal end of the bridge portion 130. The conduit 108 may be a Soft Port manufactured by Smith & Nephew. As mentioned above, the negative pressure wound treatment system 100 may include a negative pressure source, such as device 110, capable of supplying negative pressure to the wound 104 through conduit 108. Although not required, the canister or device 110 may also include other containers for storing wound exudate and other fluids that may be removed from the wound.
[0037] 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 a suitably prepared wound or an opening formed in the cover 106 placed over the wound 104. With the wound therapy device 110 connected to the connector 134 via the tube 142, the wound therapy device 110 may then be operated to provide negative pressure to the wound. The application of negative pressure may be applied until a desired level of healing of the wound is achieved.
[0038] The bridge portion 130 may include an upper channel material or layer positioned between the upper and middle layers, with a lower channel material or layer positioned between the middle and bottom layers. The upper, middle, and lower layers may have elongated portions extending between the proximal and distal ends and may include a fluid impermeable material, e.g., a polymer such as polyurethane. Of course, it will be understood that the upper, middle, and lower layers may each be constructed from 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 instances, the upper and lower layers may be curved, rounded, or outwardly convex over a majority of the length of the upper and lower layers.
[0039] The upper and lower channel layers may be elongated layers extending from the proximal end to the distal end of the bridge 130, and each may preferably comprise a porous material including an open cell foam such as, for example, polyethylene or polyurethane. In some cases, one or more of the upper and lower channel layers may be comprised of, for example, a knitted or woven spacer fabric (such as a knitted polyester 3D fabric, Baltex 7970.RTM., or Gehring 879.RTM.), or a nonwoven material, or a terry or loop pile material. The fabric is not necessarily woven and may include felt and floppy fabric materials (including materials such as Flotex.RTM.). The material selected is preferably positioned to direct wound exudate away from the wound and transmit negative pressure or evacuated air to the wound site, and may also provide the channel layer with some degree of kink or occlusion resistance. In one example, the upper channel layer may include an open cell foam such as polyurethane, and the lower channel layer may include a fabric. In another example, the upper channel layer is optional and the system may instead include 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.
[0040] The fabric or material of any component of the bridge 130 may have a three-dimensional (3D) structure, with one or more types of fibers forming a structure in which the fibers extend in all three dimensions. Such fabrics may aid in wicking, fluid transport, or negative pressure transmission in some cases. In some cases, the fabric or material of the channel may include several layers of material stacked or layered on top of each other, which may be useful in some cases in preventing the channel from collapsing under the application of negative pressure. The materials used in some implementations of the conduit 108 may be conformable and flexible, which may help in some cases to avoid bed sores and other complications that may arise from a wound treatment system pressed against a patient's skin.
[0041] The distal ends of the top, middle and bottom layers, as well as the channel layer, may be expanded at the distal ends of the layers (placed over the wound site) to form a "teardrop" or other expanded shape. At least the distal ends of the top, middle and bottom layers, as well as the channel layer, may also include at least one aperture therethrough. This aperture may be useful during manufacture of the device, as it may be used to properly align the respective layers, as well as to drain wound exudate and apply negative pressure to the wound.
[0042] In some implementations, a controlled gas leak 146 (which may also be referred to as a gas leak, air leak, or controlled air leak) may be disposed on the bridge portion 130, for example, at a proximal end of the bridge portion 130. This air leak 146 may include an opening or channel extending through an upper layer of the bridge portion 130 such that the air leak 146 is in fluid communication with the upper channel of the bridge portion 130. Upon application of suction to the conduit 108, gas (such as air) may enter through the gas leak 146 and travel 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. Gas may then be drawn into the lower channel of the bridge portion 130 by passing the opening through the upper layer, the middle layer, and the distal end of the lower layer.
[0043] The air leak 146 may include a filter. Preferably, the air leak 146 is located at the proximal end of the bridge portion 130 to minimize the possibility of wound exudate or other fluids contacting the air leak 146 or filter and blocking or impeding the air leak 146 or filter. In some instances, the filter may be a microporous membrane that may be capable of excluding microorganisms and bacteria and filtering particles larger than 45 μm. Preferably, the filter may be capable of filtering out particles larger than 1.0 μm, and more preferably, particles larger than 0.2 μm. Advantageously, some implementations may provide a filter that is at least partially chemically resistant, for example, to water, common household liquids such as shampoo, and other surfactants. In some cases, reapplication of vacuum to the suction adapter or wiping the exposed outer portion of the filter may be sufficient to clear out any foreign matter that blocks the filter. The filter may be constructed of a suitably resistant polymer, such as acrylic, polyethersulfone, or polytetrafluoroethylene, and may be oil-based or hydrophobic. In some cases, the gas leak 146 may provide a relatively constant gas flow that does not increase appreciably when additional negative pressure is applied to the conduit 108. In instances of negative pressure wound treatment systems 100 where the gas flow through the gas leak 146 increases when additional negative pressure is applied, preferably this increased gas flow will be minimized and will not increase proportionately to the negative pressure applied thereto. Further description of such bridges, conduits, air leaks, and other components, features, and details that may be used in any implementation of the negative pressure wound treatment system disclosed herein may be found in U.S. Patent No. 8,801,685, the entirety of which is incorporated by reference herein as if fully set forth herein.
[0044] Any of the wound therapy devices disclosed herein (such as device 110 or 110') may provide continuous or intermittent negative pressure therapy. Continuous therapy may be delivered above 0 mmHg, -25 mmHg, -40 mmHg, -50 mmHg, -60 mmHg, -70 mmHg, -80 mmHg, -90 mmHg, -100 mmHg, -120 mmHg, -125 mmHg, -140 mmHg, -160 mmHg, -180 mmHg, -200 mmHg, or below -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 setpoint can be set above 0 mmHg, -25 mmHg, -40 mmHg, -50 mmHg, -60 mmHg, -70 mmHg, -80 mmHg, -90 mmHg, -100 mmHg, -120 mmHg, -140 mmHg, -160 mmHg, -180 mmHg, or below -180 mmHg. The high setpoint can be set above -25 mmHg, -40 mmHg, -50 mmHg, -60 mmHg, -70 mmHg, -80 mmHg, -90 mmHg, -100 mmHg, -120 mmHg, -125 mmHg, -140 mmHg, -160 mmHg, -180 mmHg, -200 mmHg, or below -200 mmHg. During intermittent therapy, negative pressure at a low setting can be delivered for a first period of time, and at the end of the first period of time, negative pressure at a high setting can be delivered for a second period of time. At the end of the second period of time, negative pressure at the low setting can be delivered. The first and second periods of time can be the same or different values.
[0045] In operation, the wound packing 102 may be inserted into the cavity of the wound 104 and the wound cover 106 may be placed to seal the wound 104. The wound therapy device 110 may provide negative pressure to the wound cover 106, which may be transferred to the wound 104 via the wound packing 102. Fluid (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 packing 102 or one or more absorbent layers (not shown).
[0046] Wound dressings that may be used with the pump assemblies and systems of the present application may include Renasys-F, Renasys-G, Renasys AB, and Pico dressings available from Smith & Nephew. Further descriptions of such wound dressings and other components of the negative pressure wound therapy system that may be used with the pump assemblies and systems of the present application may be found in U.S. Patent Publications WO2012 / 0116334, 2011 / 0213287, 2011 / 0282309, 2012 / 0136325, and U.S. Patent No. 9,084,845, each of which is incorporated by reference in its entirety. In some cases, other suitable wound dressings may be used.
[0047] 2A, 2B, 2C, 2D, 2E, 2F, 2G, 2H, and 2I show configurations of a negative pressure wound therapy apparatus 110. In some configurations, as described, the negative pressure wound therapy apparatus 110 may have a pump assembly 160 that has a modular design, in that many of the subcomponents of the pump assembly 160 are grouped and designed to be in a module. This modular arrangement of the various components of the pump assembly 160 may make the removal and replacement of defective components of the pump assembly 160 easier and quicker.
[0048] As shown, the pump assembly 160 and canister 162 may be connected, thereby forming the wound therapy device 110. The pump assembly 160 may include a user interface, a communication interface, negative pressure generation and control, and alarm generation. Some arrangements of the pump assembly 160 may include a housing, the primary function of which is to enclose or house the electronics and other components. The housing may provide patient safety, isolation from the device interior, protect the pump device from impact damage, and provide aesthetic appeal. The housing may also provide a transparent window so that the user can view the display. The main housing may be easily removed without disturbing the rest of the device and component connections (i.e., it may be removed without having to remove electrical connectors), allowing for easier repairs.
[0049] The pump assembly 160 may also include a core assembly, also referred to as a core module (such as core assembly 212). Some arrangements of the core assembly may include all or nearly all of the electrical and mechanical components and features required for the 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 to be an easily extractable part from the pump assembly for easier and faster service and repair.
[0050] The core assembly can be easily separated into separate components for ease of service, cleaning, and assembly. The pump assembly 160 can also include a rear trim panel that can provide a USB interface, a charger port, and a speaker. The rear trim panel can be easily removed (e.g., by removing two screws and an associated screw cover plate) to allow for quick repair of the charger connector, which can be broken with misuse of the device. The pump assembly 160 can also include a handle or carrying strap, allowing for easy portability of the device.
[0051] 2C, the pump assembly 160 may 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 start and pause therapy button 180 or an alarm / alarm mute button 182. Some arrangements of the display lenses may be made from polycarbonate with a hard coat layer or from polymethylmethacrylate. 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 therapy, operate and monitor the operation of the pump assembly 160, scroll through menus displayed on the display 172, or control or perform other functions. In some cases, the command buttons 184 may be programmable and may be made from a tactile, soft rubber.
[0052] In some arrangements, the interface panel 170 may be generally flat, or may be angled slightly relative to the horizontal toward the forward surface of the pump assembly 160. For example, and without limitation, some arrangements of the interface panel 170 may be angled forward relative to the horizontal by 20° (or approximately 20°), or between 15° (or approximately 10°, or less than 10°) and 30° (or approximately 30°, or more than 30°), or any angle within the aforementioned ranges.
[0053] Additionally, the interface panel 170 may have a visual indicator 186 that may indicate which of the one or more buttons 184 are active. The interface panel 170 may also have a lock / unlock control or button 188 that may be configured to selectively lock or unlock the functionality of the various buttons (e.g., buttons 184) or display 172. In some arrangements, when the lock / unlock button 188 is in a locked state, pressing one or more of the various other buttons or displays will not cause the pump assembly 160 to change any display or performance functions of the device. In this manner, the interface panel 170 will protect the various buttons or displays from being accidentally bumped or touched. In some arrangements, the interface panel 170 may be configured such that one or more buttons on the interface panel 170 can be used while the device and / or interface panel 170 is in a locked state, but adjustments to therapy settings of the device are locked or prevented in the locked state. The interface panel 170 may be located on an upper portion of the pump assembly 160 , for example and without limitation, on an upwardly facing surface of the pump assembly 160 .
[0054] A display 172, which may be a screen such as an LCD screen, may be mounted in a middle portion of the interface panel 170. The display 172 may be a touch screen display. The display 172 supports the playback of audiovisual (AV) content, such as instructional videos, and can render a number of screens or graphical user interfaces (GUIs) for configuring, controlling, and monitoring the operation of the pump assembly 160.
[0055] 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 pump status. For example, and without limitation, the one or more indicators 174 may be configured to provide a visual indication of the status of the pump assembly 160 or other components of the negative pressure wound therapy system 100, including, but not limited to, the conduit 108 or wound cover 106 (e.g., providing an indication of normal operation, low battery, leak, canister full, blockage, overpressure, etc.). For example, and without limitation, the one or more indicators 174 may indicate various operating conditions or fault conditions of the pump assembly 160 to a user (e.g., patient, healthcare provider, etc.), including alerting the user of a normal or proper operating condition, a pump failure, a failure of the power or source supplied to the pump, detection of a leak in the wound cover or flow path (sometimes referred to as a fluid flow path), a clogged suction of the flow path, a canister full, overpressure, and / or other similar or suitable conditions, or combinations thereof. For example, and without limitation, one or more indicators 174 may indicate a system OK status, the status of the battery's level charge or that the battery is actively charging, and / or a warning or alarm condition to a user (e.g., a patient, a healthcare provider, etc.) Any suitable indicator or indicators may additionally or alternatively be used, such as visual, audible, tactile indicators, etc.
[0056] 2C illustrates a rear or back view of the wound therapy device 110 shown in FIG. 2A. As shown, the pump assembly 160 may include a speaker 192 for generating audio. For example, and without limitation, the speaker 192 may generate an audio alarm in response to deviations in therapy delivery, non-compliance with therapy delivery, or any other similar or suitable medical condition, or combinations thereof. The speaker 192 may provide audio to accompany one or more instructional videos that may be displayed on the display 172.
[0057] The pump assembly 160 may be configured to provide easy access (such as an access door on the casing of the pump assembly) to one or more filters of the pump assembly 160, such as an antibacterial filter. This allows a user (such as a medical professional or a patient) to more easily access, inspect, or replace such filters. The pump assembly 160 may also include a power jack assembly 196 (which may include a power cord) for powering the pump assembly 160 or for charging and recharging an internal power source (such as a battery). Some implementations of the pump assembly 160 may include a disposable or renewable power source, such as one or more batteries, such that a power jack is not required. The pump assembly 160 may have a recess 198 formed therein to facilitate gripping the pump assembly 160.
[0058] The canister 162 may hold fluid aspirated from the wound 104. For example, the canister 162 may have a canister body 346 with a capacity of 800 mL (or approximately 800 mL), or a capacity of 300 mL or less to 1000 mL or more, or any capacity level within this range. The canister 162 may include tubing to connect the canister body 346 to the conduit 108 to form a fluid flow path. The canister 162 may be replaced with another canister, such as when the canister 162 is filled with fluid or when the user has completed treatment.
[0059] In some arrangements, the canister 162 may comprise a low-cost disposable assembly that stores exudate extracted from a wound. The canister 162 may be non-sterile and designed for one-time use that may be disposed of after collection of exudate from a single user. The canister 162 collects wound exudate and may be available with or without a solidifying agent. The solidifying agent may solidify the exudate collected in the canister. The canister 162 may be secured under the pump assembly 160 using the locking mechanism described.
[0060] 2F, the wound therapy device 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 to a dressing port connector 144 that can be used to connect with the conduit 108.
[0061] The canister 162 may be selectively connectable and removable to the pump assembly 160. With reference to FIG. 2H, in some cases, a canister release button 202 may be pressed to selectively release the canister 162 from the pump assembly 160. With reference to FIG. 2C, the canister 162 may have one or more fill lines or graduations 204 to indicate to a user and to indicate the amount of fluid or exudate stored within the canister 162.
[0062] The wound therapy device 110 may have a handle 208 that can be used to lift or carry the wound therapy device 110. The handle 208 may be coupled to the pump assembly 160 and may be rotatable relative to the wound therapy device 110 so that the handle can be rotated upwards for lifting or carrying the wound therapy device 110 or pump assembly 160, or rotated to a lower profile for a more compact position when the handle is not in use. In some cases, the handle 208 may be coupled to the pump assembly 160 in a fixed position. The handle 208 may be coupled to an upper portion of the pump assembly 160 or may be detachable from the wound therapy device 110.
[0063] 3A is an exploded view of the pump assembly 160. Some arrangements of the pump assembly 160 are designed to facilitate the ease with which components and sub-components of the pump assembly 160 may be removed from the pump assembly 160 for cleaning, service, replacement, or otherwise. As will be described, some arrangements of the pump assembly 160 are designed such that the various components and sub-assemblies are arranged and assembled within the pump assembly 160 in a modular manner to facilitate removal, cleaning, and / or service of the various components and sub-assemblies. In some arrangements, the pump assembly 160 may have a housing 210 sized and configured to enclose at least the core assembly 212. The housing 210 may be made of acrylonitrile butadiene styrene, or any other desired or suitable material.
[0064] A core base seal 214 may be used to seal the collection canister 162 to the bottom of the pump assembly 160. A number of screws or other fasteners 215 may be used to couple the core assembly 212 to the housing 210. A rear trim assembly 216 may be coupled to the housing 210 using one or more fasteners 217, which may have one or more screw or fastener covers 219. Some configurations of the rear trim assembly 216 may have a USB port 199 or other wired connection port coupled to a printed circuit board 201 that may be included in the rear trim assembly 216. The rear trim assembly 216 may include a speaker 192 and may have other components or connectors, buttons, switches, or inputs. A USB cover 221 may be removably coupled to the USB port.
[0065] In some arrangements, the power cord 196 may be part of a power jack assembly and / or may be connected directly 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 with the electrical components of the rear trim assembly 216 and / or other components of the pump assembly 160. In some arrangements, the power jack assembly, which may include the power cord 196, may be connected to the rear trim assembly 216. The power jack assembly and pump device 160 may be configured such that in some arrangements the power cord 196 is easier to remove and replace compared to models in which the power cord is connected directly to internal electronics within the pump, which may require a service technician to disassemble the pump to replace the power cord, possibly removing it and making a new soldered connection or the like. In some arrangements of the pump assembly 160, the service technician simply removes the power jack assembly from the rear trim assembly 216 and installs a new power jack assembly and replaces the power cord 196, or, in some arrangements, removes and replaces the rear trim assembly 216 so that the power jack assembly and / or power cord 196 are installed and the power cord 196 is replaced.
[0066] The handle 208 may be coupled to a post 209 of the housing 210 that is configured to pivot relative to the housing 210. In some arrangements, the handle may be made from a thermoplastic elastomer or any other suitable or desired material. In some arrangements, the handle may be configured to simply clip 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 to the post 209 of the housing 210 or to cover a recess or recess 213 in the handle 208. The canister release button 202 may extend through an opening 203 in the housing 210.
[0067] 3C, the core assembly 212 can include an upper core assembly 226 that can be coupled to the core assembly 212 using one or more, or two or more fasteners 227, which can be screws. The upper core assembly 226 can include a display assembly 228 that can have a 2.8 inch TFT display, or a 3 inch display, or any other suitable display. The upper core assembly 226 can include a foam spacer 229 between the display assembly 228 and a printed circuit board 230 that can include a processor, memory devices, and other electronic components for operating the display assembly 228 and the pump assembly 160. One or more cable connectors can 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 can be electronically and / or physically coupled to 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), which may be coupled to other components of the core assembly 212 using fasteners 227 such that the components of the upper core assembly 226 and the display-related components of the pump assembly 160 may be removed from the other components of the core assembly 212 by removing the support base 232 and, in some arrangements, cable connectors associated with the components of the upper core assembly 226.
[0068] 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 canister 162. For example, and without limitation, the flow module 236 may have an opening 233 or port that may align with the opening 235 of the lower support 264 of the lower core assembly 254 and / or the connector interface 372 of the collection canister 162 such that air / fluid drawn through an opening 373 extending through a connector interface 372 may be drawn through the opening 233 of 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 tube connector 247 (e.g., first tube connector 247a) of the pump module 248. In any of the arrangements disclosed herein, the tube may have an inner diameter of 1 / 8 inch.
[0069] In some arrangements, the flow module 236 may be coupled to other components of the core assembly 212 using one or more fasteners 237 (three shown). The flow module 236 may be electronically coupled to other components of the core assembly 212 using flow module wire strips 238. 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 the canister or other components, as described above and below. Some arrangements of the flow module 236 may include a pressure sensor, or multiple pressure sensors. In some arrangements, a flow check valve 242 may be used to prevent the flow of air from the pump to the canister. In some arrangements, the check valve 242 may have a barbed connector for connecting with the tube and may be made from any suitable material or materials, including but not limited to acrylic and silicone.
[0070] The check valve 242 may be coupled to a tube or conduit 240 (e.g., first conduit 240a) that is coupled to a tube connector 247 (e.g., second tube connector 247b) of the pump module 248. The second conduit 240b may be coupled to a downstream connector or side of the check valve 242 to communicate air / fluid passing through the check valve 242 to an exhaust chamber 250 (also referred to herein as a noise reduction chamber or a first noise reduction chamber), as described in more detail below. For example, and without limitation, the second conduit 240b may be coupled to an inlet or opening 255 of the exhaust chamber 250 to communicate air / fluid advanced through the check valve 242 to the exhaust chamber 250, as described in more detail below. A tube clip 244 may be used to hold one or more tubes 240 to the core assembly 212.
[0071] 3E, the core assembly 212 may include a battery module 246 and a pump module 248. A cover 249 may cover one or more sides of the pump module 248. For example, and without limitation, the 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 tubing connectors 247 (which may include an inlet tubing connector and an outlet tubing connector) to which tubing may be connected.
[0072] The pump may be a diaphragm pump or any other desired or suitable type of pump, including a rotary pump, a peristaltic pump, a piezoelectric pump, or others. Some arrangements of diaphragm pumps are well suited to the required flow rates and pressures, have a long maintenance-free service life, and are relatively efficient and quiet.
[0073] In any arrangement disclosed herein, the pump module 248 may be oil-less, may be characterized by low power consumption and low sound levels, and may have a compact and lightweight design. The pump module 248 may have a 12V or 24V motor, may have a maximum flow rate rating of 4 liters / min, approximately 4 liters / min, 3 liters / min, or approximately 3 liters / min, 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.
[0074] The battery module 246 may be any suitable battery pack and may include single use and rechargeable batteries such as lithium ion batteries. Some arrangements of batteries may include lithium ion 18650 cells, or any other type of battery that does not require any of these features or characteristics, but has an adequate or abundant power source, has good power density for its size, and / or is lightweight. The battery module may include carefully designed charging circuitry with full redundancy 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 pump module 248 may be coupled to or supported by the lower core assembly 254. One or more fasteners 249 and / or cable ties may be used to couple the pump module 248 to other components of the core assembly 212.
[0075] 3F, the core assembly 212 may include an exhaust chamber 250 configured to reduce the sound level or noise generated by the pump module 248. In some arrangements, a cover plate 251 may be secured to the exhaust chamber 250 using one or more fasteners 252 (two shown). A foam element 253 may be positioned within the exhaust 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 air 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 exhaust chamber 250, and in some arrangements, the foam element 253 may have a shape similar to or the same as the shape of the space within the exhaust chamber 250 and a larger size (e.g., 10% larger in volume or dimension, or 5%-20% larger in volume or dimension) compared to the exhaust chamber 250. 3F and 3J, the exhaust chamber 250 may have an inlet 255 and an outlet 257. The inlet may include a nipple or port for receiving a tube or conduit component. The outlet 257 may essentially allow exhaust gases from the pump module 248 to exit the pump assembly 110.
[0076] Some arrangements of the pump assembly can have a noise reduction element in the exhaust flow in addition to the exhaust chamber 250 or without the exhaust chamber 250. In some arrangements, the noise reduction element can be or include an air pulse reduction chamber 460 (also referred to herein as a noise reduction chamber) downstream of the pump module 248, as shown in Figures 3G, 3H, 3I, 3J, and 3K. With reference to Figures 3G, 3H, 3I, 3J, and 3K, the noise reduction chamber 460 can be coupled with a tube or conduit 462 to the tubing connector 247 (e.g., second tubing connector 247b) of the pump module 248 such that air / fluid exhausted from the pump module 248 then passes through the noise reduction chamber 460 before exiting the pump assembly 160. The conduit 462 can be coupled with an inlet or port 464 of the air pulse reduction chamber 460. A second tube or conduit 466 may be coupled to an outlet opening or port 468 of the air pulse reduction chamber 460 such that air / fluid enters the inlet 464 of the air pulse reduction chamber 460 and exits the air pulse reduction chamber 460 through an outlet opening 468 of the air pulse reduction chamber 460. In some arrangements, the air / fluid exiting the air pulse reduction chamber 460 may then be communicated through the tube 466 through a check valve 470. In some arrangements, the check valve 470 may be the same as or similar to the check valve 242, or vice versa. The tube or conduit 472 may be coupled to the tube or conduit 476 using a connector 474 (barbed) to communicate the air / fluid from the check valve 470 to the exhaust chamber 250.
[0077] 3H and 3K, the air pulse reduction chamber 460 may have a body 480 having ports 464, 468, a cover or plate 482 coupled with an open side of the body 480, and a foam layer 484. The foam layer 484 is optional as some arrangements do not have the 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 cover 482 is not required (e.g., the body 480 and the cover 482 are integrally formed, such as by blow molding, 3D printing, or other suitable manufacturing methods). The foam layer 484 may be configured to damp sound pulses from air (or more broadly, gas) moving through the air pulse reduction chamber 460 and / or vibrations within 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 .
[0078] 3K, some configurations of the body 480 of the air pulse reduction chamber 460 may have a first inner wall segment 490 that may be positioned adjacent to the inlet opening 464. The first inner wall segment 490 may have a height equal to or similar to the height of the perimeter 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 that air / fluid entering the inlet opening 464 must pass through an opening / passage 492 between the end of the first inner wall segment 490 and the perimeter wall 483 before passing through the outlet opening 468. The first inner wall segment 490 thus acts like a flow deflector or diverter, or the fin of a baffle, attenuating the magnitude of the pulse of air from the pump module 248 (which may have a diaphragm pump) flowing through the air pulse reduction chamber 460. Some configurations of the body 480 of the air pulse reduction chamber 460 may have a recess 494 that can add additional volume to the body 480 of the air pulse reduction chamber 460 to further reduce the magnitude of the pulse of air flowing through the air pulse reduction chamber 460. Damping the magnitude of the pulse of air flowing through the air pulse reduction chamber 460 can reduce the magnitude of the air pulse imparted to the check valve 470 downstream of the air pulse reduction chamber 460 and silence the check valve 470 during operation of the pump assembly 160. Some configurations of the body 480 may have a second inner wall segment (not shown), or three or more inner wall segments, sized and positioned to block or deflect the passage of air through the air pulse reduction chamber 460.
[0079] In some arrangements, the pump module 248 may be configured to exhaust the air drawn through the collection canister 162 through an exhaust port (such as exhaust outlet or port 257), or through one or more exhaust ports. In some arrangements, such as the illustrated arrangement, the pump module 248 may be configured to exhaust the air drawn through the collection canister 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 exhaust port on the exterior of the housing 210. This may be accomplished in some arrangements because the canister 162 may have an odor filter integrated therein such that any substances or vapors that may be in the exhaust air are filtered and removed, or substantially removed, by the odor filter in the canister before the exhaust air reaches the intake of the pump assembly 160.
[0080] Further details relating to the exhaust or exhaust of the pump assembly that can be used with any arrangement of the negative pressure wound treatment system 100 disclosed herein are described in International Application WO2019 / 211732, published November 7, 2019, which is incorporated by reference herein as if fully set forth herein.
[0081] 4A, 4B, 4C, 4D, 4E, 4F, 4G, and 4H show the 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 to or integrally formed with the actuator 262. 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 can selectively couple the canister 162 with the pump assembly 160.
[0082] One or more fasteners 270 (four shown) can be used to couple the second support 264 to the base support 216. The actuator 262 can be positioned between the base support 260 and the second support 264 and is 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 can move along a first axis A1 between the first position and the second position. The first axis A1 can be generally parallel to an axial centerline of the button 202 and / or the spring 272. In the first position, the actuator 262 can 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 (shown in FIG. 3B) of the canister 162, such that the canister 162 is securely engaged with the lower core assembly 254 of the pump assembly 160 when the actuator 262 is in the first position. A first position of the actuator 262 is shown, for example and without limitation, in Figures 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, i.e., the pump assembly 160. The second position of the actuator 262 is shown, for example and without limitation, in Figure 4G.
[0083] The actuator 262 may be moved from a first position to a second position to press or move the canister release button 202 towards the second support 264. A spring or other resilient member 272 may be positioned between a portion of the actuator 262 (for example, and without limitation adjacent the canister release button 202) and the second support 264 to bias the actuator 262 towards the first position. In this configuration, upon release of the canister release button 202, the spring 272 automatically moves the actuator 262 from the second position to the first position if the actuator 262 is in the second position.
[0084] Some arrangements of the actuator 262 may have a base 263 and an opening 280 extending through and generally perpendicular to the base 263 that is large enough to receive the neck portion 274 of the canister 162 (for example, and without limitation, when the actuator 262 is in the second position). 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 to move between a first position and a second position as the latch 282 moves between the first position and the second position. The button 202 may extend away from the 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 generally perpendicular to the axial centerline A2 of the opening 280 of the actuator 262. 4C , the canister release button 202 may extend away from the opening 280 through an opening 281 formed in a tab portion of a flange 283 that projects away from a base 298 of the base support 260. Further, the actuator 262 may be configured such that the actuator 262 moves between a first position to a second position in a direction generally perpendicular to an axial centerline A2 of the opening 280.
[0085] The actuator 262 may have a first set of slots 290 disposed generally in a direction generally parallel to the first axis A1. The actuator 262 may have a second set of slots 292 disposed at an angle relative to the direction of the first axis A1, for example, at an angle of approximately 45° relative to the first axis AI, or between 40° and 50°, or between 30° and 60° relative to the first axis A1. The slots 290 may be configured to receive first and second protrusions 296, 297 extending from a base 298 of the base support 260. The length of the slots 290 may be long enough to permit movement of the actuator 262 between a first position and a second position before the protrusions 296, 297 inhibit movement of the actuator 262.
[0086] 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 protrusion 296 extending from the base support 260. The opening 269 may extend through the first locking arm 266 in a direction generally 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, with the first protrusion 296 extending through the opening 269 of 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.
[0087] Similarly, the second locking arm 268 can have an opening 273 extending through a body portion 275 of the second locking arm 268 that can be configured to receive a second one of the protrusions 296 extending from the base support 260. The opening 273 can extend through the second locking arm 268 in a direction generally parallel to an axial centerline A2 of the opening 280 extending through the actuator 262. The second locking arm 268 can be configured to rotate about the second protrusion 297. For example, with the second protrusion 297 extending through the opening 273 of the second locking arm 268, the opening 273 can rotate about the second protrusion 297 as the second locking arm 268 rotates about the second protrusion 297.
[0088] The second set of slots 292 may be configured to receive protrusions 300, 302 extending from the body portions 271, 275 of the first locking arm 266 and the second locking arm 268, respectively. The length of the slots 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 slots 292 may also limit the range of movement of the first and second locking arms 266, 268 as they rotate about the first and second protrusions 296, 297. The second set of slots 292 may be angled and configured to apply a force to the protrusions 300 of the first and second locking arms 266, 268 when the actuator 262 moves from the first position to the second position of the actuator 262, thereby rotating the first and second locking arms 266, 268 radially outward from the first position to the second position of the first and second locking arms 266, 268.
[0089] The first and second locking arms 266, 268 may be configured to move or rotate between a first position and a second position. In the first position, the projection or latch 304 of the first locking arm 266 and the projection or latch 306 of the second locking arm 268 may overlap and engage with the flange or neck portion 274 of the canister 162 or cap assembly 360 (as shown in Figures 4D and 4E). That is, they may overlap with a radially extending surface 375 of the flange or neck portion 274 of the canister of the cap assembly 360. In the second position, 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, as shown in Figures 4D and 4G.
[0090] Some arrangements of the base support 260 may have a slot 320 formed in the base portion 298 of the base support 260. The slot 320 may be configured to receive a second protrusion 322 extending away from the second surface of the first and second locking arms 266, 268. The protrusion 322 extending away from the second surface of the first and second locking arms 266, 268 may extend in an opposite direction to the direction in which the protrusion 300 extends from the first and second locking arms 266, 268. The slot 320 may be configured to allow the protrusion 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. Additionally, the base support 260 may have an opening 321 formed through the base 298 of the base support 260, the opening 321 extending generally in a direction parallel to the axial centerline A2 of the opening 280 of the actuator 262. The opening 321 may be large enough to receive the flange or neck portion 274 of the canister 162 therein.
[0091] In some cases, the spring 272 can be axially positioned relative to a support surface 330 formed on a portion of the second support 264. A central protrusion 332 can also extend away from the support surface 330 to limit movement of an end of the spring member 272 relative to the surface of the support surface 330. A recess 334 can be formed in a flange portion 336 formed about the support surface 330. The recess 334 can be configured to receive a tab portion or flange 284 of the actuator 262 as the actuator 262 moves from the first position to the second position.
[0092] Some arrangements of the canister 162 can have a canister body 346 with one or more angled protrusions 348 formed on the top surface 349 of the canister body 346. The actuator 262 can have a first protrusion or tab 350 and a second protrusion or tab 352 that can extend through openings 354, 356, respectively, formed through the base 298 of the base support 260. The first and second protrusions 350, 352 can extend in a direction generally parallel to an axial centerline A2 that extends through an opening 280 formed in the actuator 262. The protrusions can move from a first position to a second position when the actuator 262 moves from the first position to the second position of the actuator 262. The first and second protrusions 350, 352 can interact with angled or inclined surfaces of one or more angled protrusions 348 formed on the top surface 349 of the canister 162. In some arrangements, as the first and second protrusions 350, 352 move along the angled surface of the angled protrusion 348, the first and second protrusions 350, 352 may exert a force on the angled protrusion 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.
[0093] In the other arrangement, a protrusion 348 formed on an upper surface 349 of the canister 162 can be used to facilitate one-handed removal of the canister 162 from the pump assembly 160, but without pushing the canister 162 away from the pump assembly 160, as described with respect to the other arrangements above. The protrusion 348 formed on the upper surface 349 of the canister 162 engages with the first and second protrusions 350, 352 to hold the first and second protrusions 350, 352 in an open position, thereby allowing a user to remove the canister 162 from the pump assembly 160 without having to hold the first and second protrusions 350, 352 in an open position. For example, as described above, when the canister release button 202 is pressed, the first and second protrusions 350, 352 of the actuator 262 move across the inclined surface of the protrusion 348 formed on the top surface 349 of the canister 162 until the first and second protrusions 350, 352 move past the protrusion 348. In this position, the orthogonal surface of the protrusion 348 on the canister 162 prevents the first and second protrusions 350, 352, and therefore the actuator 262, from returning to an initial or locked position, such that a user can remove the canister 162 from the pump body 160 without continuing to press the canister release button 202. In this arrangement, a user can remove the canister 162 from the pump assembly 160 in a one-handed operation (i.e., with one hand).
[0094] The canister 162 may be configured to include all of the disposable or usable items typically associated with the use of a canister (including, for example and without limitation, a sealing ring or gasket for sealing the canister, and an odor filter) as part of the canister, or a removable canister component, such that the sealing ring and odor filter are removed with the canister when the canister 162 is removed from the pump assembly 160. This may improve the efficiency and ease of installing a new canister onto the pump assembly 160 such that "between-patient" servicing can be streamlined. In some arrangements, "between-patient" servicing may include, or in some arrangements may only include, the following steps: removal of a used or partially filled canister 162, cleaning at least the exterior surfaces of the pump assembly 160 with a disinfectant cleaner, installing a new canister 162, and performing a self-test of the pump assembly 160 via the user interface of the pump assembly 160. Again, this can greatly simplify service procedures and make capital purchase and rental supply modes easier for some deployments of the negative pressure wound therapy system 100.
[0095] In some arrangements, the canister 162 may include a canister body 346. The canister body 346 in some arrangements may include a blow molded one-piece design made from a clear polymer that allows the exudate to be viewed, or a translucent polymer that allows the level of exudate to be determined. The canister body 346 may be made from a naturally translucent material, such as polypropylene or high density polyethylene, which are low cost and non-toxic.
[0096] Some arrangements of the canister 162 may have a cap assembly 360 that may be configured to removably couple (for example, and without limitation, threadedly couple) with an opening in the canister body 346. Figures 5A, 5B, 5C, 5D, and 5E show arrangements of the cap assembly 360 that may be included in any of the canisters 162 disclosed herein. With reference to Figures 5A, 5B, 5C, 5D, and 5E, some arrangements of the cap assembly 360 may include a cover 362 having a flange 274 (which may be an annular flange) and an opening 363 axially through a central portion of the first cap member 362.
[0097] The cap assembly 360 may also have a cap body 370 having a connector interface 372 that projects axially from a first major surface 371 of the 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 passageway for air and / or other gases within the canister body 346 to pass through and exit the canister body 346. The connector interface 372 may also have an annular groove 374 configured to receive and support a sealing ring 376 therein. The sealing ring 376 may be a rubber O-ring, or an O-ring made of silicone or another suitable material.
[0098] The 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 bacteria from the air flowing through the filter 390. The hydrophobic filter 386 may be used to prevent any liquid from leaking from the canister body 346 through the opening 373 in the cap body 370 and may be positioned on one or both sides of the odor filter 390. The odor filter 390 may include any suitable filter membrane or material, including carbon. For example, and without limitation, some configurations of the odor filter 390 may include compressed carbon.
[0099] Conventional negative pressure wound therapy pumps often receive complaints about bad odors. Because odor filters are typically located on the exhaust of the device, over time odors tend to build up in the internal tubing and pump motor. The arrangement of the present disclosure prevents or at least inhibits any bacteria or other odor-causing substances from exiting the canister 162 by providing a filter (e.g., filter 390) in the canister 162 to prevent such bacteria and other odor-causing substances from passing through the cap assembly 360 and into the pump assembly 160. This arrangement also has the benefit of preventing bacteria buildup and other odor-causing substances from contaminating the pump assembly 160, thereby allowing for reuse of the pump assembly 360 without requiring substantial cleaning of the air passages through the pump assembly 360.
[0100] In some arrangements, the 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 within the canister. The carbon element may have a variety of shapes and sizes depending on the canister. The carbon element is the first part of the filtration system, followed by a hydrophobic membrane. This ensures that in some arrangements, odors are the first to be filtered as air is drawn from the canister to the pump. As shown, this filtration system may be attached to or form part of the canister cap assembly 360. Additionally, including an odor filter within the canister may eliminate the costly and more difficult task of replacing an odor filter within the inside of the pump assembly.
[0101] Different sizes and shapes of carbon filters can be used to increase its effectiveness for different canister shapes. Nevertheless, the premise of having a filtration system remains the same for each of these different sizes and shapes of carbon filter element and cap assembly 360, where the air must pass through the carbon disk and then the hydrophobic membrane. For any arrangement, a spacer may be placed between the carbon filter and the hydrophobic filter. This may be needed to support the membrane and hold the carbon filter in the desired position.
[0102] The cap assembly 360 may also include a base cap support 392 that may be configured to provide a support surface for the filter 390 and / or other components of the 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 to inhibit or prevent liquid or exudate within the canister 346 from splashing onto at least a portion of the filter 390 and / or the hydrophobic filter 386. For example, and without limitation, the shield 393 may overlap at least 40% of the surface area of the first major surface of the filter 390, or at least 50% of the surface area of the first major surface of the filter 390, or between at least 40% and at least 60% of the surface area of the first major surface of the filter 390.
[0103] The shield 393 can have openings 394 therein through which air and / or other gases can pass as the air and / or other gases are drawn through the cap assembly 360 when the pump is operating. In some arrangements, the shield 393 can block a majority, or 60% or approximately 60% of the surface of the filter 390 from exposure to exudate in the canister 346. In other words, in some arrangements, the openings 394 extending through the base cap support 392 can be reduced by 60% or approximately 60% or more in the shield 393 compared to the openings through the base cap support 392 without the shield 393. In some arrangements, the openings 394 extending through the base cap support 392 can be reduced by 40% (or approximately 40% or less) to 80% (or approximately 80% or more), or 50% (or approximately 50%) to 70% (or approximately 70%) compared to the openings through the base cap support 392 without the shield 393.
[0104] The base cap support 392 may have a bottom support or standoff 396 that may support the filter 390. One or more fluid passages 395 may be formed through the bottom support or standoff 396. The passages may communicate with a recess 399 formed in the base cap support 392 such that air passing through the passage 395 may pass through or fill the recess 399. In some arrangements, the recess 399 may be sized and configured to receive and support the filter membrane 390 therein. The recess 399 may be configured such that all, or substantially all, of the air or gas coming from the canister body 346 must pass through the filter 390 before passing through the opening 373 of the cap assembly 360. The base cap support 392 may also have an annular flange or lip 402 thereon.
[0105] 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 during operation, one or more protrusions 400 (two shown) extend into the interior space of the canister body 346.
[0106] 6A, 6B, 6C, 6D, 6E, and 6F show other arrangements of the filter 600 and filter support 602 that can be used in place of or in addition to other filters described herein for any of the arrangements of the negative pressure wound therapy system 100 disclosed herein, as well as for other arrangements of the negative pressure wound therapy system 100. For example, as shown in FIG. 6A, some arrangements of the filter 600 and filter support 602 shown therein can filter odors, bacteria, and other substances or materials from air drawn from a collection canister (such as canister 162). A hydrophobic filter 604 can be positioned on one or both sides of the filter 600. Air can flow through a first opening 606 in the filter support 602 and then be forced through the filter 600 and hydrophobic filter 604 before entering a pump assembly (such as pump assembly 160). In the variation shown in FIG. 6B, the air may pass through a number of openings 616 in the filter support 612 before passing through the filter 610 and the hydrophobic filter 614 .
[0107] In a variation of filter 610 shown in FIG. 6B, filter 610 may have a disk-shaped portion 610a and a tapered or cone-shaped portion 610b that extends downward toward the inside of the canister, for example, with the filter narrowing as it extends away from the disk-shaped portion of the filter. Filter support 612 may have a shape that complements the shape of filter 610. Opening 616 may pass through the cone-shaped or tapered portion of filter support 612. This arrangement may increase the flow path of air through filter 610 to increase filtration of air exiting the canister, and may increase the surface area of the cover over filter 610 to reduce the amount of filter 610 that may be exposed to splashing or sloshing of exudate within the canister.
[0108] 6C may have a tapered shape that increases in size toward the lower end of filter 620 and is narrowest at its upper end. Hydrophobic filter 624 may be spaced from filter 620 by spacer member 623. Filter support 622 may have a shape that complements the shapes of filter 620, spacer member 623, and hydrophobic filter 624. Openings 626 in the bottom surface of filter support 622 may provide a fluid passageway for air through filter 620.
[0109] 6D, 6E, and 6F show additional variations in the shapes of filters 630, 640, 650 and filter supports 632, 642, 652 that can be used in any of the configurations of the negative pressure wound therapy system 100 disclosed herein. A hydrophobic filter 634, 644, 654 may be positioned on or adjacent to any of the filters 630, 640, 650, and one or more openings 636, 646, 656 may permit airflow through the filter supports 632, 642, 652.
[0110] In some arrangements, the negative pressure wound therapy system 100 can have an odor filter that filters the exhaust flow exiting the pump module 248. The odor filter that filters the exhaust flow exiting the pump module 248 can be located inside the housing 210 or outside the housing 210, which can provide easier access for servicing and / or replacement of the odor filter (i.e., when located outside the housing 210). In some arrangements, the filter can be attached to the top of the canister 162.
[0111] In some arrangements, the operation of such filters can be described as follows: A pump can pull negative pressure on the canister contents through a first port, thereby drawing air and exudate from the dressing. The exudate can be separated within the canister and air can be drawn through the pump unit and exhausted to a second port. A carbon filter can be attached to the exterior of the canister, and when the canister is properly installed in the device, the filter is forced up against the second port. The exhaust air can be forced through a filter (which can be a carbon filter or any other suitable odor and / or bacterial type filter). The filter can remove bacterial by-products before exhausting the exhaust air to the atmosphere.
[0112] The filter arrangements disclosed herein may use simple and low-cost filter technology, such as, and not limited to, foam with carbon impregnation. The filter may be placed on or within the canister to ensure filter replacement when the canister is changed. Additionally, the filter may provide exhaust muffling. In some arrangements, the filter may be a wet-side filter located inside the canister. Additionally, in some arrangements, one or more additives may be added to the canister to reduce bacterial count or growth. Additionally, in some arrangements, the dry filter may be located within the canister cap, but not at the pump inlet, but in a separate compartment accessible only by the exhaust of the pump unit. This may include two ports, an inlet port and an outlet port on the canister cap, in some arrangements.
[0113] Conventional NPWT pumps generate noise during operation. The noise comes from the mechanical movement of components within the pump (commonly the pump head) that tend to form air being drawn in and expelled by the pump. This noise can be a nuisance to patients and can be directly linked to treatment outcomes as patients tend to turn off the pump to stop the noise. These treatment interruptions slow the wound healing process.
[0114] Some arrangements of the pump assembly 160 disclosed herein may include an in-line filter connected to tubing in the pump housing, as well as a baffle box to reduce noise from the pump motor. Some arrangements of the pump assembly 160 may include a filter membrane on the exhaust port on the pump assembly 160. The filter membrane may include a Porex PTFE membrane vent, a Pall Verspor (for example, and not limited to, a Pall Verspor 1200 filter) vent, or any sheet type membrane that can be attached to the housing of the pump assembly 160 at the exhaust port. In some arrangements, the filter may have a disk shape and may be glued to the housing of the pump assembly 160. In some arrangements, the filter may be enclosed in a housing, cover, or a fastening lid that can be attached to the outer surface of the housing of the pump assembly 160. The filter may also include a paper filter sheet. Additionally, some arrangements of the filter may be configured to create an impermeable barrier that prevents fluid from entering the enclosure if the device is placed upside down or tilted. Additionally, such filters may also be configured to provide additional filtration against odors emitted from the pump motor.
[0115] In some arrangements, the tube 142 connected to the canister 162 may have a length sufficient to connect to a dressing or port that is at least 2 feet, or at least 3 feet, or 1 to 3 feet or more away from the canister 162. The tube 142 may be coupled to a connector 440 that extends away from a surface of the canister 162. The connector 440 may be in fluid communication with an interior space within the canister body 346 and may be configured to couple with an end of the tube 142. All or a portion of the tube 142 may be wrapped around the canister 162 if all or a portion of the tube 142 is not needed.
[0116] Some arrangements of the negative pressure wound treatment system 100 may be configured to support the tube 142 on or within the pump assembly 160 and / or the canister 162 to manage the tube 142. The tubes (such as the tube 142) are reported by patients as being invasive during daily life. Because wounds may be on different parts of the body, some arrangements of the negative pressure wound treatment system 100 may be provided with a length of the tube 142 to accommodate the most remotely located wounds. Configuring the negative pressure wound treatment system 100 to manage any excess tubes may be beneficial in terms of preventing tripping hazards, preventing fall hazards, and keeping the negative pressure wound treatment system 100 more orderly. Accordingly, some arrangements of the negative pressure wound treatment system 100 disclosed herein may have one or more clips that are removably or non-removably attached to the exudate tube 142 and that can be used to secure the excess tubes to the negative pressure wound treatment system 100. In some arrangements, the tubing may be wrapped around the pump assembly 160 and / or the canister 162, minimizing the profile of the tubing and allowing the user to control the length of the tubing that extends away from the negative pressure wound treatment system 100.
[0117] 7A and 7B, in some arrangements, one or more tube supports 444 (also referred to as clips) may be coupled or attached to the housing 210 or canister body 346 (not shown) of the pump assembly 160 (shown) and may be configured to selectively support the tube 142. Some arrangements of the tube supports 444 may be removably attached to or coupled with the canister body 346. Additionally, the tube support 444 may have an enclosed opening 446 through which the tube 142 may pass, a first open support 448 to which a portion of the tube may be removably secured or held, and / or an optional second open support 450 to which a portion of the tube may be removably secured or held. The enclosed opening 446 may be used to non-removably attach the tube 146 to the tube support 444. The tube support 444 may also have a retaining portion 454 that can be used to secure the tube support 444 to a receiving portion 456 of the housing 210 of the pump assembly 160. The tube support 444 fits into and out of a slot 456 to selectively secure the tube support 444 to the pump assembly 160 (shown) or the canister body 346 (not shown).
[0118] In some implementations, the tube support 444 may be secured to the housing 210 using slots or other attachment elements on the housing 210 or the canister body 346. In this implementation, the tube is then wrapped around the housing 210 and the tube support 444 secures an additional loop of tube around and through the housing 210. The tube support 444 may also be configured to slide onto the tube such that the tube support is at approximately the midpoint of the tube (e.g., the tube may pass through an enclosed opening 446 in the tube support 444). The tube may then be formed into a coil that may be removably secured to the tube support 444.
[0119] As shown, some configurations of the negative pressure wound treatment system 100 may have two or more tube supports 444, i.e., one on each of two side portions of the negative pressure wound treatment system 100. In other configurations, the negative pressure wound treatment system 100 may have only one tube support 444, or three or more tube supports 444, depending on the length of the tubes 142. Additionally, the tube supports 444 may be positioned on any desired portion of the pump assembly 160 and / or canister 162.
[0120] The tube support 444 may have any desired shape or features. For example, some implementations of the tube support 444 may be configured to have a strap around an opening or retaining portion to hold the tube 142 to the tube support 444. In other arrangements, the tube 142 may be supported within an interior space or cavity within the pump assembly 160 and / or canister 162 where the tube can be rolled up. In this arrangement, the user can pull the required or desired length of the tube from the interior space and then activate a locking mechanism to secure the remaining portion of the tube within the interior space. In other arrangements, the tube may be supported within a pouch or cavity that is attached to the exterior of the pump assembly 160 and / or canister 162. In some arrangements, the tube may be fused such that the user must separate the portion of the tube that is to be used, and the remaining portion of the tube is secured or held in the negative pressure wound therapy system 100.
[0121] In some arrangements, the pump assembly 160 may be configured such that the center of gravity is much lower than conventional pump assemblies. This may improve the stability of the pump assembly 160 and the negative pressure wound therapy system 100 and reduce instances of inadvertent tipping of the negative pressure wound therapy system 100. For example, and without limitation, the center of gravity may be approximately 40% of the total height of the pump assembly 160 (not including the handle 208), or 35% (or approximately 35%) of the total height of the pump assembly 160 (not including the handle 208) to 50% (or approximately 50%) of the total height of the pump assembly 160 (not including the handle 208). Additionally, as shown, the buttons and other inputs of the interface panel 170 may be on a top surface of the pump assembly 160 such that input forces applied to the pump assembly 160 when a user provides physical input to the pump are in a generally downward direction. This may reduce the likelihood of the pump assembly 160 inadvertently tipping over when a user provides input to the pump assembly 160.
[0122] 9 shows a schematic diagram of a control system 1300 that can be used with any of the wound therapy devices described herein, such as wound therapy device 110′ and / or wound therapy device 110. The control system 1300 can be similar to the electronic assemblies described herein. The electrical components can operate to accept user input, provide output to a user, operate a pressure source, provide connections, etc. A first processor (such as main controller 1310) can be responsible for user activity, and a second processor (such as pump controller 1370) can be responsible for controlling another device, such as a pump 1390.
[0123] An input / output (I / O) module 1320 can be used to control input and / or output to another component or device, such as a pump 1390, one or more sensors (e.g., one or more pressure sensors 1325 configured to monitor pressure at one or more locations in the fluid flow path), etc. For example, the I / O module can receive data from one or more sensors via one or more ports, such as serial (e.g., I2C), parallel, hybrid ports, and the like. Any of the pressure sensors can be part of the wound therapy device or the canister. In some cases, any of the pressure sensors 1325 can be remote to the wound therapy device, such as positioned at or near the wound (e.g., in a dressing or a conduit connecting the dressing to the wound therapy device). In such implementations, any of the remote pressure sensors can communicate with the I / O module via a wired connection or with one or more transceivers 1340 via a wireless connection.
[0124] The main controller 1310 can receive and provide data to and from one or more expansion modules 1360, such as one or more USB ports, SD ports, compact disc (CD) drives, DVD drives, FireWire ports, Thunderbolt ports, PCI Express ports, etc. The main controller 1310, along with other controllers or processors, can store data in memory 1350 (e.g., one or more memory modules), which can 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), etc.
[0125] The main controller 1310 may be a general-purpose controller, such as a low-power processor or an application-specific processor. The main controller 1310 may be configured as the "central" processor within the electronic architecture of the control system 1300, and the main controller 1310 may coordinate the activities of other processors, such as a pump controller 1370, one or more communication controllers 1330, and one or more additional processors 1380. The main controller 1310 may run a suitable operating system, such as Linux, Windows CE, VxWorks, etc.
[0126] The pump controller 1370 can control the operation of a pump 1390 that can generate negative pressure or reduced pressure. The pump 1390 can be a suitable pump, such as a diaphragm pump, a peristaltic pump, a rotary pump, a rotary vane pump, a scroll pump, a screw pump, a liquid ring pump, a membrane pump operated by a piezoelectric transducer, a voice coil pump, and the like. The pump controller 1370 can measure the pressure in the fluid flow path, calculate the fluid flow rate, and control the pump using data received from the one or more pressure sensors 1325. The pump controller 1370 can control a pump actuator (such as a motor) such that a desired level of negative pressure is achieved in the wound 104. The desired level of negative pressure can be selected by a pressure setting or a user. The pump controller 1370 can control the pump (e.g., a pump motor) using pulse width modulation (PWM) or pulse control. The control signal for driving the pump can be a 0-100% duty cycle PWM signal. The pump controller 1370 can perform flow rate calculations and detect alarms. The pump controller 1370 can communicate information to the main controller 1310. The pump controller 1370 can be a low power processor.
[0127] Any of the one or more communication controllers 1330 may provide a connection (such as a wired or wireless connection 1332). The one or more communication controllers 1330 may utilize one or more transceivers 1340 to transmit and receive data. 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, etc. Any of the one or more transceivers 340 may function as a communication controller. In such cases, the one or more 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 communication. The one or more communication controllers 1330 may provide one or more of the following types of connections: Global Positioning System (GPS), cellular connectivity (e.g., 2G, 3G, LTE, 4G, 5G, etc.), NFC, Bluetooth connectivity (or BLE), radio frequency identification (RFID), wireless local area network (WLAN), wireless personal area network (WPAN), WiFi connectivity, internet connectivity, optical connectivity (e.g., using infrared, barcodes such as QR codes, etc.), acoustic connectivity, ultrasonic connectivity, etc. The connectivity may be used for a variety of activities such as pump assembly location tracking, asset tracking, compliance monitoring, remote selection, uploading logs, alarms, and other operational data, as well as adjusting therapy settings, software or firmware upgrades, pairing, etc.
[0128] 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. The one or more communication controllers 1330 may communicate information to the main controller 1310. Any of the one or more communication controllers 1330 may include internal memory or may utilize memory 1350. Any of the one or more communication controllers 1330 may be a low power processor.
[0129] The control system 1300 can store data such as GPS data, therapy data, device data, and event data. This data can be stored, for example, in memory 1350. This data can include patient data collected by one or more sensors. The control system 1300 can track and log therapy and other operational data. Such data can be stored, for example, in memory 1350.
[0130] Using connections provided by one or more communications controllers 1330, the control system 1300 can upload any of the data stored, maintained, or tracked by the control system 1300 to a remote computing device, such as device 1334. The control system 1300 can also download (e.g., via connections to device 1334) various operational data, such as therapy selections, parameters, firmware and software patches and upgrades. One or more additional processors 1380 can be utilized, such as a processor for controlling one or more user interfaces (such as one or more displays). In some cases, any of the illustrated or described components of the control system 1300 can be omitted depending on the deployment of the wound monitoring or treatment system in which the control system 1300 is used.
[0131] Any of the negative pressure wound therapy devices described herein may include one or more features disclosed in U.S. Patent No. 9,737,649 or U.S. Patent Publication WO 2017 / 0216501, each of which is incorporated by reference in its entirety.
[0132] Multiple dressing negative wound therapy FIG. 10 illustrates another negative pressure wound treatment system 1400. The system 1400 may include a wound therapy device capable of providing negative pressure to a wound site(s), such as wound therapy device 110. The wound therapy device 110 may be in fluid communication with one or more wound dressings 1406a, 1406b (collectively referred to as 1406) to provide negative pressure to one or more wounds, such as wounds 104a and 104b. The fluid connection between the wound dressings 1406 and the wound therapy device 110 may be referred to as a fluid flow path (e.g., a path along which fluid drawn from the wound flows via negative pressure). A first fluid flow path may include components that provide a fluid connection from the wound therapy device 110 to the first wound dressing 1406a. As non-limiting examples, the first fluid flow path may include a passage from the wound dressing 1406a to the wound therapy device 110 in fluid connection with the wound therapy device 110, or a passage from the first wound dressing 1406a to the inlet 1446 of the branch attachment (or connector) 1444. Similarly, the second fluid flow path may include components that provide a fluid connection from the wound therapy device 110 to the second wound dressing 1406b.
[0133] System 1400 may be similar to system 100, except that multiple wounds 104a and 140b are treated by system 1400. System 1400 may include any one or more of the components of system 100 (wounds 104a and 104b, covers 106a and 106b, etc.) shown in FIG. 4 with the letter "a" or "b" added to distinguish the first wound from the second wound. As illustrated, system 1400 may include multiple wound dressings 1406a, 1406b (and corresponding fluid flow paths) in fluid communication with wound therapy device 110 via multiple suction adapters, such as adapter 108. The suction adapter may include any one or more of the components of adapter 108 (such as bridge portions 130a and 130b, connectors 134a and 134b, and caps 140a and 140b) shown in FIG. 4 with the letter "a" or "b" added to distinguish between the first and second wounds.
[0134] Without limitation, the suction adapter for systems 1400a and 1400b may include a controlled leakage channel fluidly separated from the suction channel. The wound dressing and fluid flow path may each include various features or elements that match or are similar to features or elements of another wound dressing or fluid flow path in the system. For ease of reference, one or more corresponding features or elements may be collectively referred to using a corresponding non-alphabetical reference number. 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 collectively referred to elements may not be identical and may have different features or attributes.
[0135] In some arrangements, the dressings 1406a, 1406b may be placed over an opening or aperture formed in each of the drapes or wound covers 106a, 106b, which may be filled with a wound packing material, such as foam or gauze, in some cases, placed over the suitably prepared wounds 1430a, 1430b. The wound therapy device 110 may be fluidly coupled to the inlet 1446 of the connector 1444 via the tube 142. The connector 1444 may be fluidly coupled to the connectors 134a, 134b, which may be fluidly coupled to the tubes or conduits 130a, 130b via the branches 1445a, 1445b and the tubes or conduits 1442a, 1442b. The tubes or conduits 130a, 130b may be fluidly coupled to the dressings 1406a, 1406b. Once all of the conduit and dressing components are connected and operatively positioned, the wound therapy device 110 can be operated to provide negative pressure to the wounds 1430a, 1430b via the fluid flow paths. The application of negative pressure can be applied until a desired level of healing of the wound 1430 is achieved. Although two wounds and wound dressings are shown in FIG. 4, some implementations of the wound therapy device 110 can provide treatment to a single wound (e.g., by closing an unused branch 1445a or 1445b of the connector 1444) or to three or more wounds (e.g., by adding branches to the connector 1444).
[0136] In any of the configurations disclosed herein, the inlet manifold branch attachment 1444 or conduit may include one or more valves, clamps, caps, air leaks, or other flow control mechanisms that may be configured to allow fluid to enter the fluid flow path or to block or restrict the flow or passage of fluid through the fluid flow path. In some arrangements, the valves, air leaks, or other flow control mechanisms of the inlet manifold branch attachment 1444 may be electronically opened or closed. For example, the controller of the wound therapy device 110 may be in communication with the valves, air leaks, etc. to open or close each individually or as a unit. This communication may be wired or wireless.
[0137] In some arrangements, the system 1400 can apply negative pressure to one or more wounds. The level of negative pressure in the one or more wounds (e.g., under one or more wound dressings) can be sufficiently close to the level of negative pressure in the negative pressure source. For example, an acceptable level of pressure maintained in the wound can be within ±1 mmHg, ±5 mmHg, ±10 mmHg, ±25 mmHg, etc. of the negative pressure set point. In some arrangements, this pressure can be maintained at this level within 95% (or another suitable percentage) of the time that the system 1400 applies negative pressure. In some arrangements, acceptable pressure levels can include a pressure range of -40 to -120 mmHg. However, other pressure levels can be used as described herein.
[0138] One or more air leaks, such as air leaks in one or more fluid flow paths, can be utilized to determine one or more operating conditions within the system. For example, the air leak can be a controlled air leak that allows a relatively constant flow of air, gas, or other fluid into the fluid flow path. In some arrangements, the flow from the air leak to the fluid flow path can be configured and / or controlled to not increase appreciably as additional negative pressure is applied to the system. However, the presence of an air leak in the system can maintain a substantially constant baseline flow through the system when a steady state is achieved (e.g., when a negative pressure set point is reached). The presence of an air leak can require further activation of the negative pressure source to maintain a desired negative pressure level at the wound. Thus, the system can determine the presence of one or more operating conditions (blockage, leak, full canister, misalignment of suction adapter, etc.) by monitoring the flow through the fluid flow path, which can be measured directly or indirectly, for example, based on monitoring the activity of the negative pressure source.
[0139] In some arrangements, each fluid flow path can include an air leak, and each air leak in each fluid flow path can allow a different flow rate of air, gas, or other fluid into the system. In other words, each air leak in the system can have a different leak rate. For example, the leak rate of an air leak can 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 or filter, the level of blockage of the air leak or filter, etc. Fluid entering a fluid flow path increases the flow rate of that fluid flow path.
[0140] 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., the aggregate of the flows to each wound dressing) may be monitored, calculated, or determined and then used to determine the operating conditions of the system 1400. The operating conditions may include, for example, a "no flow" condition (e.g., all flow paths are blocked), a blocked condition in one or more flow paths (e.g., a blocked condition exists in a first fluid flow path, a blocked condition exists in a second fluid flow path, etc.), a canister full condition, a normal condition (e.g., no blockage exists in any of the fluid flow paths), etc.
[0141] The system 1400 may include one or more features disclosed in U.S. Patent Publication No. WO2020 / 0069850 or International Publication No. WO2018 / 167199, each of which is incorporated by reference in its entirety.
[0142] In some arrangements, the system 1400 may provide an indication, such as an alarm, to communicate to a user the operating status of the system 1400 based on a comparison of the determined total flow rate to one or more flow thresholds. In some arrangements, the flow thresholds may be pre-determined to correspond to the operating conditions of the system 1400. In some arrangements, the flow thresholds are based at least in part on dynamic measurements or calculations of the system 1400, such as flow rates or pressures, during a particular mode of the system (e.g., a calibration mode).
[0143] handle 8A, 8B, 8C, and 8D show alternative arrangements of the handle 1208 that may be used with any implementation of the pump device disclosed herein (including, for example and without limitation, any arrangement of the pump device 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 more rigid or have a more solid feel in the second state than in the second state. In some arrangements, the handle 1208 may be configured to be changeable between the first state to the second state by flipping the handle 1208. For example, referring to FIGS. 8A and 8B, an implementation of the handle 1208 is shown in a first state in which the handle is more flexible. The same handle 1208 is shown in FIGS. 8C, 8D in a second state in which the handle is more rigid or has a more solid feel.
[0144] 8A, 8B, 8C, and 8D, the handle 1208 may have a base 1210 with a first opening 1212 and a second opening 1212 through the end of the base 1210. The first and second openings 1212 may be used to couple the handle 1208 to the pump device using any suitable fastener. However, in other arrangements, the handle 1208 may be coupled to the pump device using any suitable feature, including a reversible locking mechanism similar to a cable tie, a latch mechanism, or other quick release connector. For example, the pump device may have a depressible feature that may be used to selectively release the end of the handle 1208 so that the handle may be removed and changed from a first state to a second state, or replaced with a second handle that is more rigid or more flexible. As a further example, some configurations of pump assembly 160 may have lobes on the pump housing 210 that correspond to complementary features on the handle 208 such that the handle 208 can be removed and / or attached only when the handle 208 is in a fully forward position. When the handle 208 is pulled straight back or extended to a fully rearward position, the lobes may be configured to engage with rings inside the handle mounting bosses that keep the handle 208 coupled with the lobes while allowing the handle 208 to freely rotate relative to the housing 210.
[0145] The handle 1208 may also have a number of compression elements 1216 that protrude away from a first surface 1218 of the base 1210. When the handle 1208 is in the first or flexible state, the first surface 1218 may extend or face generally outward, as shown in FIG. 8A, and the compression elements 1216 also face generally outward (in some arrangements, radially outward). The compression elements 1216 may have a generally trapezoidal or tapered shape in some arrangements, and may have spaces 1220 between each of the compression elements 1216, at least when the handle 1208 is in the first or flexible state. The curvature of the base 1210 allows the spaces 1220 to expand or open, such that the ends of the compression elements 1216 do not contact each other when the compression elements 1216 face outward in the first state, as shown in FIG. 8A. When the compression elements 1216 are facing inward, such as in the second state as shown in FIG. 8C, the curvature of the base 1210 causes the ends of the compression elements 1216 to eliminate the space between the compression elements 1216 and contact and / or compress against each other, thereby causing the compression elements 1216 to increase the stiffness or hardness of the handle 1208 and inhibit the flexibility of the handle 1208.
[0146] In other arrangements, the base 1210 may be made of a stretch fabric with compression elements (also referred to herein as studs), each preferably having a trapezoidal or suitable shape that protrudes away from one of the major surfaces of the base, which provides more flexibility and a strap-like feel in the flexible orientation, but retains stiffness in the orientation where the trapezoidal studs meet. In any arrangement disclosed herein, the compression elements can have any desired shape and are not limited to a trapezoidal shape. For example, and without limitation, the compression elements 1216 may have any suitable or desired shape with tapered surfaces between each element that allows the handle to be flexible when there is a space between each of the compression elements 1216 and more rigid when each of the compression elements 1216 is in contact with an adjacent compression element 1216.
[0147] Figures 11A, 11B, 11C, and 11D show a canister assembly 1600 arrangement that may be used with any of the pump assembly arrangements disclosed herein, including any of the pump assembly 160 arrangements disclosed herein. Figure 11D is a cross-sectional view of the canister assembly 1600 through line 11D-11D shown in Figure 11C. Any of the canister assembly 1600 arrangements disclosed herein may have any of the components, features, or other details of any other canister assembly arrangements disclosed herein, including, but not limited to, any of the canister 162 arrangements described above, in any combination with any of the components, features, or details of the canister assembly 1600 disclosed below. Similarly, any component, feature, or other detail of any of the other canister or canister assembly arrangements disclosed herein may have any of the components, features, or other details of any arrangement of canister assembly 1600 disclosed herein, in any combination with any of the components, features, or details of the canister or canister assembly.
[0148] In any of the arrangements disclosed herein, the canister assembly 1600 may have a canister body 1602, a conduit or tube 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 body 1600. The canister body 1602 may have one or more, or a plurality of flanges 1627 (three shown) configured to engage with or be engaged by a latch, protrusion, or other selectively or non-selectively securable tab or other feature of the pump assembly (such as, but not limited to, latches 304, 306, and / or latch 282 of locking arms 266, 268 described above). The canister body 1600 may have a first or upper portion 1602a and a second or lower portion 1602b and may be of any desired size, including at or about 300 mL, or at or about 200 mL to at or about 400 mL. The first portion 1602a may be coupled to the second portion 1602b. For example, and without limitation, the first portion 1602a may be welded, glued, or otherwise secured to the second portion 1602b. In other arrangements, the first portion 1602a may be integrally formed with the second portion 1602b. The components of the canister body 1602 may be injection molded or formed by any other suitable method. A sealing 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 1602a. A removable cap 1612 for the tubing connector 1608 may be coupled to the tubing 1606 near the tubing connector 1608.
[0149] 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 body 1602 configured to increase the thickness or viscosity of 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 1602a. For example, the gelling agent 1622 may be sandwiched between the first protrusion 1630 and the second protrusion 1632. In this arrangement, the first and second protrusions 1630, 1632 may be used to prevent the gelling agent 1622 from migrating around the interior space 1624 of the canister body 1602.
[0150] 11D, the filter assembly 1620 may be used to filter air passing from the interior space 1624 of the canister body 1602 through the opening or passageway 1621 of the connector interface 1618 to the pump assembly and may include a hydrophobic filter 1640, an odor filter 1642, and a dust filter 1644 that may be used to block (e.g., prevent) dust or other particles from passing through the pump assembly. The odor filter 1642 may also be configured to filter bacteria from the air flowing through the filter assembly 1620. The hydrophobic filter 1640 may be used to prevent any liquid from leaking out of the canister body 1602 and contacting the odor filter 1642. The odor filter 1642 may include any suitable filter membrane or material, including carbon. For example, and without limitation, some configurations of the odor filter 1642 may include compressed carbon. The filter assembly 1620 is also shown in Figures 12C and 12D. The first body portion 1602 may have one or more protrusions or standoffs formed on an inner surface of the first body portion 1602 similar to or identical to the protrusions 1765 formed or positioned on the first body portion 1702 of the canister assembly 1700 shown in Figure 12D. The protrusions may be used to space the dust filter 1644 away from a planar surface within the first body portion 1602a, 1702a to allow for greater flow of air through the dust filter 1644.
[0151] In some arrangements, the filter 1642 may include a carbon activated foam material. In some arrangements, the filter 1642 may include compressed carbon elements as part of a filtration system within the canister. The carbon elements may have various shapes and sizes depending on the canister. Different sizes and shapes of the carbon filter may be used to increase its effectiveness for different canister shapes. The filter assembly 1620 may be optionally positioned within a recess formed in the first body portion 1602a, such as recess 1767 formed in the first body portion 1702a, as shown in FIG. 12D.
[0152] The filter assembly 1620 may be supported at a lower or inner end by a base support 1650, which may be configured to provide a support surface for the hydrophobic filter 1640 and / or other components of the filter assembly 1620. The base support 1650 may have one or more openings 1652 through its main surface 1653 through which air and / or other gases can pass as the air and / or other gases are drawn by a pump through the filter assembly 1620.
[0153] Some arrangements of the base support 1650 may optionally be configured to support a sensor or sensors and / or other electronic components. With reference to FIG. 12C, some arrangements of the base support 1650 may have a support surface 1654 configured to support a sensor 1658 and / or other electronic components. For example, and without limitation, the base support 1650 may have a support surface that is approximately parallel to the top surface of the canister assembly 1600. In some arrangements, the base support 1650 may also have one or more support tabs 1655 (two shown) to provide additional support for the sensor or 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 when the canister is fully responsive to detection of a current conducted between the electrodes through a liquid (e.g., wound exudate) aspirated into the canister. The support tab 1655 may support a pair of electrodes that may be positioned on an outwardly facing side of the support tab 1655.
[0154] The support tabs 1655 may extend away from the support surface 1654 towards the bottom of the canister. The support tabs 1655 may have a flange or shield 1657 at a distal end of each of the support tabs 1655 to prevent liquids (e.g., wound exudate) within the canister from splashing onto the support tabs 1655 and / or the electronic components 1658 (such as electrodes) and exposing the gel packets 1622 or gelling agent mounds. In some arrangements, the flanges 1657 may each extend at an angle (e.g., a perpendicular angle) away from the support tabs 1655. In other arrangements, the flanges 1657 may extend at an angle that is greater than or less than 90 degrees relative to the support tabs 1655.
[0155] In some arrangements, the electronic component 1658 may optionally be a fill level sensor or a canister full sensor. The fill level sensor may have a wireless transmitter (which may optionally be a short range communication transmitter) that may be configured to communicate status information (such as the detected fill level or whether the canister is full) to the pump assembly or other wireless receiver, or may have a wired connection through the canister that communicates with the pump assembly.
[0156] The base support 1650 may have an annular flange 1660 about its periphery and a recess 1662 that may be configured to receive and support at least the hydrophobic filter 1640. The base support 1650 may optionally be welded, glued, or otherwise coupled within an inner surface of the first body portion 1602a of the body 1602 of the canister assembly 1600 before the first and second portions 1602a, 1602b of the body 1602 are coupled together.
[0157] 12A, 12B, 12C, and 12D show another arrangement of a canister assembly 1700 that may be used with any of the pump assembly arrangements disclosed herein, including any of the arrangements of the pump assembly 160 disclosed herein. Any arrangement of the canister assembly 1700 disclosed herein may have any of the components, features, or other details of any other canister assembly arrangement disclosed herein, including, but not limited to, any of the arrangements of the canister 162 and / or canister assembly 1600 described above, in any combination with any of the components, features, or details of the canister assembly 1700 disclosed below. Similarly, any component, feature, or other detail of any of the other canisters or canister assembly arrangements disclosed herein may have any of the components, features, or other details of any arrangement of the canister assembly 1700 disclosed herein, in any combination with any of the components, features, or details of the canister or canister assembly.
[0158] In any of the arrangements disclosed herein, the canister assembly 1700 may have a canister body 1702, a conduit or tube 1606 having a connector 1608 at its distal end, a connector interface 1618, and a filter assembly 1620 housed within the canister body 1700, as described above. The canister body 1700 may have a first or upper portion 1702a and a second or lower portion 1702b, and may be of any desired size, including at or about 800 mL, or at or about 600 mL to at or about 1000 mL. In any of the arrangements disclosed herein, the canister assembly 1700 may also have a gelling agent 1622 (which may be in a package or bag) positioned within an interior space 1724 of the canister body 1702.
[0159] 12D , the filter assembly 1620 of the canister assembly 1600, 1700 arrangement may include a hydrophobic filter 1640, an odor filter 1642 which may optionally be upstream of the hydrophobic filter 1640, and a dust filter 1644 which may optionally be upstream of the odor filter 1642 and may be used to block (e.g., prevent) dust or other particles from passing through the pump assembly. The filter assembly 1620 may be supported at a lower or inner end by a base support 1650 which may be configured to provide a support surface for the hydrophobic filter 1640 and / or other components of the filter assembly 1620. The base support 1650 may optionally be welded, glued, or otherwise coupled within an inner surface of the first body portion 1702a of the body 1702 of the canister assembly 1700 before the first and second portions 1702a, 1702b of the body 1702 are coupled together.
[0160] Figures 13A and 13B show another arrangement of a canister assembly 1800 that may be used with any of the pump assembly arrangements disclosed herein, including any of the pump assembly 160 arrangements disclosed herein. Figures 14A and 14B show another arrangement of a canister assembly 1900 that may be used with any of the pump assembly arrangements disclosed herein, including any of the pump assembly 160 arrangements disclosed herein.
[0161] In any arrangement disclosed herein, any component, feature, or other detail of canister assembly 1800 or canister assembly 1900 may have any of the components, features, or other details of any other canister assembly arrangement disclosed herein, including, but not limited to, any of the above-mentioned canister 182 and canister assembly 1600, 1700 arrangements, in any combination with any of the components, features, or details of canister assemblies 1800, 1900 disclosed below. Similarly, any component, feature, or other detail of any other canister or canister assembly arrangement disclosed herein may have any of the components, features, or other details of any of the canister or canister assembly arrangements disclosed herein, in any combination with any of the components, features, or details of the canister or canister assembly.
[0162] Some configurations of the canister assembly 1900 may be identical to the canister assembly 1800, except for the size or volume of the canister assembly. The canister body 1800 may have any desired size or capacity, including at or about 300 mL, or from at or about 200 mL to at or about 400 mL. The canister body 1900 may have any desired size or capacity, including at or about 800 mL, or from at or about 600 mL to at or about 1000 mL.
[0163] In any of the arrangements disclosed herein, the canister assemblies 1800, 1900 may each have a canister body 1802, 1902, a conduit or tube 1606 having a clip 1607 and connector 1608 at its distal end, a connector interface 1818, and a cap assembly 1820 that may be coupled to the canister body 1800. The tube 1606 may be coupled to a tube connector 1609 that may be secured to the canister body 1802, 1902. The canister body 1802 may be blow molded or formed by any desired or suitable method. The canister assemblies 1800, 1900 may have a cap assembly 1820 that may have any of the components, features, or other details of any other cap assembly arrangement disclosed herein, including, but not limited to, any of the cap assembly 360 arrangements 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 of the other cap assembly arrangements disclosed herein may have any of the components, features, or other details of any of the arrangements of cap assembly 1820 disclosed herein, in any combination with any of the cap assembly components, features, or details.
[0164] In some arrangements, the cap assembly 1820 may be configured to be removably coupled (for example, and without limitation, threadedly coupled) with an opening (such as 1903 shown in FIG. 14C ) of the canister body 1802, 1902. In some arrangements, the cap assembly 1820 may be welded to the canister body 1802, 1902 or otherwise non-removably coupled to the canister body. 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 project axially away from a 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 passageway for air and / or other gases within the canister body 1802, 1902 to pass through and exit the canister body 1802, 1902.
[0165] The cap assembly 1820 may include a top filter 1826 and an odor filter 1828. The top filter 1826 may be a hydrophobic filter and / or a dust filter. The odor filter 1828 may also be configured to filter bacteria from the air flowing through the filter 1828. The top filter 1826 may be used to prevent any liquids from leaking out of the canister body 1802, 1902 through the opening 1824 of the first cap member 1822 and may be positioned on one or both sides of the odor filter 1828. The odor filter 1828 may include any suitable filter membrane or material, including carbon. For example, and without limitation, some configurations of the odor filter 1828 may include compressed carbon.
[0166] The cap assembly 1820 may also include a base cap support 1830 that 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 insulate or shield the one or more filters 1826, 1828 from exudates and / or other liquids in 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 to inhibit or prevent liquids or exudates in the canister 1802, 1902 from splashing onto at least a portion of the odor filter 1828 and / or top 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 approximately 60%-90% or approximately 90% of the surface area of the first major surface of filter 1828.
[0167] The base cap support 1830 may have one or more openings 1844 formed therein through which air and / or other gases may pass as the air and / or other gases are drawn through the cap assembly 1820 when the pump is operating. The cap assembly 1820 may be configured such that all, or substantially all, of the air or gas coming from the canister body 1802, 1902 must pass through the filter 1828 before passing through the openings 1844 in the cap assembly 1820. In some arrangements, there may be three or more, or four or more, or five or more openings 1844 formed in the base cap support 1830. The openings 1844 may be formed in a wall perpendicular to the upper major surface of the canister body 1802, 1902 such that exudate is less likely to splash or pass through the openings 1844, for example, the openings 1844 may be formed in a vertical wall of the base cap support 1830.
[0168] In any of the arrangements 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 body 1802, 1902 that is configured to increase the thickness or viscosity of liquid, which may include wound exudate, within the interior space of the canister.
[0169] FIG. 15A is a top, front, and left side perspective view of an arrangement of device 2000 for applying negative pressure to a wound.
[0170] FIG. 15B is a front view of the arrangement of device 2000 of FIG. 15A.
[0171] FIG. 15C is a rear view of the arrangement of device 2000 of FIG. 15A.
[0172] FIG. 15D is a right side view of the arrangement of device 2000 of FIG. 15A.
[0173] FIG. 15E is a left side view of the arrangement of device 2000 of FIG. 15A.
[0174] FIG. 15F is a top view of the arrangement of device 2000 of FIG. 15A.
[0175] FIG. 15G is a bottom view of the arrangement of device 2000 of FIG. 15A.
[0176] FIG. 16A is a top, front, and left side perspective view of another arrangement of an apparatus 2100 for applying negative pressure to a wound.
[0177] FIG. 16B is a front view of the arrangement of device 2100 of FIG. 16A.
[0178] FIG. 16C is a rear view of the arrangement of device 2100 of FIG. 16A.
[0179] FIG. 16D is a right side view of the arrangement of device 2100 of FIG. 16A.
[0180] FIG. 16E is a left side view of the arrangement of device 2100 of FIG. 16A.
[0181] FIG. 16F is a top view of the arrangement of device 2100 of FIG. 16A.
[0182] FIG. 16G is a bottom view of the arrangement of device 2100 of FIG. 16A.
[0183] FIG. 17A is a top, front, and left side perspective view of another arrangement of an apparatus 2200 for applying negative pressure to a wound.
[0184] FIG. 17B is a front view of the arrangement of device 2200 of FIG. 17A.
[0185] FIG. 17C is a rear view of the arrangement of device 2200 of FIG. 17A.
[0186] FIG. 17D is a right side view of the arrangement of device 2200 of FIG. 17A.
[0187] FIG. 17E is a left side view of the arrangement of device 2200 of FIG. 17A.
[0188] FIG. 17F is a top view of the arrangement of device 2200 of FIG. 17A.
[0189] FIG. 17G is a bottom view of the arrangement of device 2200 of FIG. 17A.
[0190] FIG. 18A is a top, front, and left side perspective view of another arrangement of an apparatus 2300 for applying negative pressure to a wound.
[0191] FIG. 18B is a front view of the arrangement of device 2300 of FIG. 18A.
[0192] FIG. 18C is a rear view of the arrangement of device 2300 of FIG. 18A.
[0193] FIG. 18D is a right side view of the arrangement of device 2300 of FIG. 18A.
[0194] FIG. 18E is a left side view of the arrangement of device 2300 of FIG. 18A.
[0195] FIG. 18F is a top view of the arrangement of device 2300 of FIG. 18A.
[0196] FIG. 18G is a bottom view of the arrangement of device 2300 of FIG. 18A.
[0197] In any of the arrangements 2000, 2100, 2200, 2300 shown and described herein, any of the solid lines in such arrangements may be dashed lines used to indicate features that are not part of the claimed ornamental design. The scope of the present disclosure includes all lines shown, whether dashed or solid.
[0198] Other Variations Although some configurations describe negative pressure wound therapy, the systems, devices, and / or methods disclosed herein may be applied to other types of therapy that can be used standalone or in addition to TNP therapy. The systems, devices, and / or methods disclosed herein may be extended to any medical device, particularly 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, neurostimulation, microwave therapy, activators, antibiotics, antimicrobials, or the like. Such devices may further provide TNP therapy. The systems and methods disclosed herein are not limited to medical devices and may be utilized by any electronic device.
[0199] Any transmission of data described herein may be performed securely, for example utilizing one or more of encryption, https protocol, secure VPN connection, error checking, delivery confirmation, or the like.
[0200] Any values of thresholds, limits, periods, etc. provided herein are not intended to be absolute values and may therefore be approximate values. In addition, any thresholds, limits, periods, etc. provided herein may be fixed or changed automatically or by a user. Furthermore, as used herein, terms expressing a relative degree, such as exceeding, over, or under, in relation to a reference value, are intended to encompass equality to the reference value. For example, exceeding a positive reference value can encompass being equal to or greater than the reference value. Additionally, as used herein, terms expressing a relative degree, such as exceeding, over, or under, in relation to a reference value, are intended to encompass the inverse of the disclosed relationship, such as under, under, or over, in relation to a reference value.
[0201] It should be understood that features, materials, properties, or groups described in connection with a particular aspect, arrangement, or embodiment are applicable to any other aspect, arrangement, or embodiment described herein, unless inconsistent 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, except combinations in which at least some of such features and / or steps are mutually exclusive. Protection is not limited to the details of the foregoing arrangements. Protection extends to any novel, or any novel combination, of features disclosed in this specification (including any accompanying claims, abstract, and drawings), or any novel, or any novel combination of steps of any method or process similarly disclosed.
[0202] Although specific configurations have been described, these configurations are presented as examples 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. Additionally, various omissions, substitutions, and changes may be made in the form of the methods and systems described herein. Those skilled in the art will recognize that in some arrangements, the actual steps performed in the illustrated or disclosed processes may differ from those shown in the figures. Depending on the configuration, some of the above steps may be removed or other steps may be added. For example, the actual steps and / or order of steps performed in the disclosed processes may differ from those shown in the figures. Depending on the configuration, some of the above steps may be removed or other steps may be added. For example, various components illustrated in the figures or disclosed 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. The instructions may be executed by a processor, controller, ASIC, FPGA, or dedicated hardware. Hardware components may include logic circuitry, such as controllers, processors, ASICs, FPGAs, and the like. Additionally, the features and characteristics of the specific arrangements disclosed above may be combined in various ways to form additional arrangements, all of which would fall within the scope of the present disclosure.
[0203] 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 screens may include additional and / or alternative information. The components may be arranged, grouped, and displayed in any suitable order.
[0204] In particular, conditional language such as "can," "could," "might," "may," "for example," and the like, are generally intended to convey that certain configurations include certain features, elements, and / or conditions while other configurations do not, unless specifically stated otherwise or understood within the context in which they are used. As such, such conditional language is not necessarily intended to suggest that features, elements, and / or conditions are in any way required in one or more configurations, or that one or more configurations necessarily include logic for determining whether those features, elements, and / or conditions are included in or should be implemented in any particular configuration, with or without author input or instruction. Terms such as "include," "comprise," and "having" are synonymous and are used in an inclusive, open-ended manner and do not exclude additional elements, features, acts, operations, and the like. Also, the term "or" is used in an inclusive sense (not an exclusive sense), e.g., when used to join a list of elements, it means one, some, or all of the elements in the list. Additionally, the term "each" as used herein, in addition to having its ordinary meaning, can also refer to any subset of the set of elements to which the term "each" applies. Furthermore, as used herein, the words "herein," "above," "below," and similar words, when used in this application, are meant to refer to the specification as a whole and not to specific portions of the specification.
[0205] Unless otherwise indicated, conjugated language such as the phrase "at least one of X, Y, and Z" should be understood in the context in which it is used to generally convey that an item, term, etc. can be either X, Y, or Z, or combinations thereof. Thus, such conjugated language is not generally intended to suggest that a particular configuration requires that at least one of X, at least one of Y, and at least one of Z, each be present.
[0206] As used herein, degree-descriptive phrases, such as the terms "approximately," "about," "generally," and "substantially," refer to values, amounts, or characteristics that are close to a given value, amount, or characteristic that still performs a desired function or produces a desired result. For example, the terms "approximately," "about," "generally," and "substantially" can refer to an amount that is within 10%, 5%, 1%, 0.1%, and 0.01% of a given amount. As another example, in a particular arrangement, the terms "approximately parallel" and "substantially parallel" refer to a value, amount, or characteristic that deviates from exactly parallel by 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, or 0.1 degrees or less.
[0207] Unless expressly stated otherwise, articles such as "a" or "an" should generally be construed to include one or more of the listed items. Thus, phrases such as "an apparatus configured to" are intended to include one or more of the listed apparatus. Such one or more listed apparatuses may also be collectively configured to perform the stated enumeration.
[0208] Although the present disclosure includes specific configurations, embodiments, and applications, it will be understood by those skilled in the art that the disclosure extends beyond the specifically disclosed configurations to other alternative configurations and / or uses and obvious modifications thereof and their equivalents, including configurations that do not provide all of the features and advantages described herein. Thus, the scope of the present disclosure is not intended to be limited by the specific disclosure of preferred configurations herein, but may be defined by the claims presented herein or hereafter.
Claims
1. 1. A negative pressure wound therapy device comprising: a negative pressure source including an inlet and an outlet, the negative pressure source configured to provide negative pressure to a wound covered with a wound dressing via a fluid flow path to draw fluid from the wound; a first noise reduction chamber positioned within the fluid flow path downstream of the negative pressure source and in fluid communication with the 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 reduce the level of pressure pulses in the fluid advancing through the negative pressure source, the first noise reduction chamber including an inlet and an outlet; a second noise reduction chamber positioned within 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 the level of pressure pulses in the fluid advancing through the negative pressure source and the first noise reduction chamber, the second noise reduction chamber including an inlet and an outlet; a check valve positioned within the fluid flow path and configured to prevent fluid from flowing in a reverse direction toward the negative pressure source; Including, the second noise reduction chamber is spaced from the first noise reduction chamber; the second noise reduction chamber is different from the first noise reduction chamber; A negative pressure wound therapy device, wherein the first noise reduction chamber is configured to reduce the level of pressure pulses in the fluid advancing through the negative pressure source to reduce noise generated by the check valve.
2. 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 reduce the level of pressure pulses within the fluid advancing through the negative pressure source.
3. 3. The apparatus of claim 1 or 2, 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.
4. 4. The apparatus of claim 1, wherein the second noise reduction chamber is positioned in series with and downstream of the first noise reduction chamber.
5. The apparatus of claim 2 , wherein the second noise-reduction chamber is closer to the exhaust of the apparatus than the first noise-reduction chamber.
6. The apparatus of any one of claims 1 to 5, further comprising foam positioned in at least one of the first and second noise reducing chambers.
7. 7. The apparatus of claim 1, wherein the first noise reduction chamber includes an inner wall extending across a majority of the distance between the first wall and the second wall of the first noise reduction chamber positioned adjacent to or opposite the first wall such that an opening is formed between an end of the inner wall and the second wall, and the first noise reduction chamber is configured to form a passage between the inlet and the 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 the inner wall segment and the second wall.
8. 8. The apparatus of claim 1, wherein an internal volume of the first noise reduction chamber and the second noise reduction chamber is greater than a volume in 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 a volume in 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.
9. The apparatus of any one of claims 1 to 8, further comprising a flow module including one or more pressure sensors and solenoid valves.
10. The apparatus of any one of claims 1 to 9, wherein the negative pressure source comprises a motor, the apparatus further comprising a power source configured to power the motor.
11. 11. An apparatus according to any one of claims 1 to 10, comprising a canister connectable to the apparatus and configured to collect fluid drawn from the wound as a result of negative pressure being provided to the wound by the negative pressure source, and a cap connectable with an opening on the canister.
12. 12. The device of claim 11, further comprising a filter coupled to or supported by the cap.
13. The device of claim 12 , wherein the filter comprises a carbon filter.
14. The device of any one of claims 11 to 13, further comprising a hydrophobic filter associated with or supported by the cap.