Pump for applying negative pressure to a wound through a wound treatment device

Description

Pump for applying negative pressure to a wound through a wound treatment device. Separated from BR112023010028-3, filed on November 24, 2021. FIELD OF THE INVENTION

[0001] This invention relates to a system for treating a wound and, in particular, a system for removing fluid from a wound, and a system for supplying fluid and for removing fluid from a wound, and related components for such systems. BACKGROUND

[0002] The technique of applying negative pressure to manage wound exudate and accelerate the healing of various wounds has been used for some time. Applying negative pressure to an external wound to effect a therapeutic benefit is commonly referred to as negative pressure wound therapy or NPWT. This therapy can accelerate the formation of granulation tissue in open external wounds, such as diabetic foot ulcers, surgical wounds with dehiscence, and various acute and chronic wounds to support secondary and tertiary intention healing. A variety of special topical dressing systems are applied to these wounds to deliver negative pressure from a negative pressure source to a wound (Figure 1). Internal closed surgical wounds have also been treated by applying suction (a vacuum) to a surgical site through a drain or device placed internally to remove wound fluids after surgery.

[0003] The applied negative pressure reduces the free volume of the wound care space to draw exudate from the wound toward the negative pressure source, where the exudate is discharged into a collection reservoir or dressing that is typically located in Petition 870260060944, dated 06 / 22 / 2026, page 10 / 266 2 / 102 between the injury and the source of negative pressure.

[0004] Negative pressure is supplied to a wound care space by a vacuum unit or vacuum device. Vacuum devices for wound care face several design challenges. Vacuum devices are either disposable or reusable and ideally need to be readily portable, therefore the components must be lightweight, energy-efficient, and preferably low-cost.

[0005] Existing systems may be susceptible to blockage by clotted blood, fibrin, adipose tissue, loose tissue debris, and wound exudate. Mechanical vacuum pumps for use in negative pressure treatment systems may also be susceptible to blockage, particularly where vacuum systems are small in size. Furthermore, vacuum systems are typically located remotely from the wound where accurate pressure measurement and regulation directly at the target site may be difficult to achieve, due to the potential for blockages to occur within the mechanical vacuum pump assembly or elsewhere in the system, and the volume change within the fluid collection reservoirs.

[0006] Some prior art systems comprise a pressure relief valve to control negative pressure in a wound, for example, as described in US patent. 2007 / 0179460. A pressure relief valve operates to introduce air into the system to prevent the applied vacuum pressure from rising above an upper limit pressure, or to return the system to ambient pressure. Such systems can result in a loss of negative pressure at the wound treatment site and may negatively impact the wound healing process.

[0007] Once a system has reached a pressure ne Petition 870260060944, dated 06 / 22 / 2026, page 11 / 266 3 / 102 The desired negative pressure system typically remains sealed or closed off from the environment, with the only input being exudate produced at the wound site. A system can reach a state of equilibrium, resulting in the wound fluid retained in the system becoming static or stagnant even when additional exudate is produced at the wound site. This static or stagnant fluid can further exacerbate blood clotting, tissue debris sedimentation, and fibrin formation, which can lead to an increased risk of blockage and failure to apply negative pressure to the wound. Furthermore, stagnation of excess wound exudate can increase the risk of infection, edema, and can also lead to biofilm formation and subsequent interrupted healing.

[0008] An additional difficulty with administering negative pressure therapy is often a difference in height at the wound site, for example, when the patient is upright or in a standing position. A height differential at the wound can result in preferential fluid flow from upper portions of the wound, with the fluid remaining static in a lower portion of the wound.

[0009] In addition to applying negative pressure to a wound for therapeutic pressure treatment, the ability to introduce fluid along the wound site can be useful for administering wound cleansing fluids, saline solution, pain medications, cell suspensions, treatment solutions, and other liquid medications to suppress bacteria or to purge a wound.

[0010] Existing vacuum devices that can also introduce treatment fluids have the same design limitations as standard non-administration variants. They are typically large in size due to the integrated rigid waste collection containers being positioned between the vacuum pump. Petition 870260060944, dated 06 / 22 / 2026, page 12 / 266 4 / 102 cuo and the injury, and / or require a large amount of energy to power the pumping components within the device, which can add to the size and complexity of the system.

[0011] Treatment fluid is typically applied to the wound through a fluid supply line that is subjected to positive pressure to ensure complete saturation of the wound site, resulting in the wound site remaining at an ambient or positive pressure level. These systems then subsequently apply a vacuum to the wound site to draw treatment fluid and exudate away from the wound site by reducing the free volume of the treatment space in response to the applied negative pressure, which is subsequently collected in the reservoir or attached collection container. The positive pressure applied to the wound treatment site can have unintended consequences, such as inducing leakage of the dressing into the wound, typically between the perimeter and a covering dressing.Loss of vacuum pressure can also cause various elements of topical wound dressings to shift, such as the foam carrier layer / wound interface or the fluid supply and exudate fluid conduits, which can lead to a short circuit in the fluid flow path through the wound. This short circuit can result in zero treatment fluid delivery to the wound.

[0012] It is an object of the present invention to address one or more of the disadvantages mentioned above and / or at least to provide the public with a useful alternative.

[0013] In this descriptive report, where reference has been made to patent descriptive reports, other external documents, or other sources of information, the objective is generally to provide context for discussing features of the invention. Unless specifically stated otherwise. Petition 870260060944, dated 06 / 22 / 2026, page 13 / 266 5 / 102 otherwise stated, reference to such documents or external sources of information should not be interpreted as an admission that such documents or sources of information, in any jurisdiction, are prior art or form part of the common general knowledge in the art. SUMMARY OF THE INVENTION

[0014] In a first aspect, the present invention provides a system for treating a wound comprising: a fluid inlet and a fluid outlet for connection to a wound treatment device located at the wound, wherein the fluid inlet is adapted to be fluidly connected to an upstream side of the wound treatment device and the fluid outlet is adapted to be fluidly connected to a downstream side of the wound treatment device; an air inlet valve upstream of the fluid outlet; an actuator to operate the air inlet valve between an open and a closed position; a pump downstream of the fluid inlet; A motor to drive the pump to provide negative pressure to the wound treatment device; and a controller in communication with the actuator and the motor to operate the air inlet valve and the pump; the controller being configured to: i) Open the air inlet valve and operate the pump to maintain an initial vacuum pressure in the wound treatment device and introduce air into the wound treatment device; ii) Close the air inlet valve and operate the pump to maintain a second vacuum pressure in the wound treatment device and remove air and fluid from the wound treatment device; Petition 870260060944, dated 06 / 22 / 2026, page 14 / 266 6 / 102 where the first vacuum pressure is less than or equal to the second vacuum pressure.

[0015] In a second aspect, the present invention provides a system for treating a wound comprising: a fluid inlet and a fluid outlet for connection to a wound treatment device located at the wound, wherein the fluid inlet is adapted to be fluidly connected to an upstream side of the wound treatment device and the fluid outlet is adapted to be fluidly connected to a downstream side of the wound treatment device; an air inlet valve upstream of the fluid outlet and an actuator to operate the air inlet valve between an open and a closed position; A treatment fluid inlet upstream of the fluid outlet to connect a treatment fluid supply; a treatment fluid valve between the treatment fluid inlet and the fluid outlet, and an actuator to operate the fluid inlet valve between an open and a closed position; a pump downstream of the fluid inlet; A motor to drive the pump to provide negative pressure to the wound treatment device; and a controller in communication with the air inlet valve actuator, the fluid valve actuator, and the motor to operate the air inlet valve, the fluid valve, and the pump; the controller being configured to: i) Open the air inlet valve and operate the pump to maintain an initial vacuum pressure in the wound treatment device and introduce air into the wound treatment device; ii) Close the air inlet valve and operate the pump to Petition 870260060944, dated 06 / 22 / 2026, page 15 / 266 7 / 102 Maintain a second vacuum pressure in the wound treatment device and remove air and fluid from the wound treatment device, wherein the first vacuum pressure is less than or equal to the second vacuum pressure; and in a fluid supply state and with the air inlet valve closed: iii) Open the fluid inlet valve and operate the pump to maintain a vacuum pressure in the wound treatment device and introduce the treatment fluid into the wound treatment device; iv) . close the fluid inlet valve and operate the pump to maintain a vacuum pressure in the wound treatment device and remove fluid from the wound treatment device.

[0016] The first or second aspect of the invention may include any one or more of the features described in relation to the third, fourth and fifth aspects of the invention.

[0017] In a third aspect, the present invention provides a pump for applying negative pressure to a wound through a wound treatment device, the pump comprising: an actuation mechanism; at least one flexible chamber, the drive mechanism configured to actuate the chamber to compress and expand the chamber; a pair of one-way valves in fluid communication with the chamber, the pair of one-way valves comprising an inlet valve for fluid flow into the chamber, and an outlet valve for fluid flow out of the chamber; a pump inlet in fluid communication with at least one inlet valve; and a pump outlet in fluid communication with at least one inlet valve. Petition 870260060944, dated 06 / 22 / 2026, page 16 / 266 8 / 102 minus one outlet valve; The compression of the chamber causes fluid to flow out of the chamber, through the outlet valve and the pump outlet, and the subsequent expansion of the chamber draws fluid from the pump inlet through the inlet valve and into the chamber; and the one-way inlet and outlet valves each have a single orifice in only one fluid flow path through the pump from the pump inlet to the pump outlet through the inlet valve, the chamber and the outlet valve to allow fluid and tissue debris to pass through the valves when open.

[0018] In a fourth aspect, the present invention provides a wound treatment device for applying negative pressure to an external wound, the device comprising: a portable component to be received in an external wound cavity and substantially fill a wound treatment space; a layer of dressing to cover the wound; a fluid supply conduit, and the fluid supply conduit has one or more supply conduit outlets; a fluid removal conduit, the fluid removal conduit having one or more removal conduit inlets; The supply and removal conduits are placed in the treatment space with the inlet(s) of the removal conduit and the outlet(s) of the supply conduit in fluid communication with the portability component and with the outlet(s) spaced from the inlet(s), so that the fluid flow from the outlet(s) to the inlet(s) is through a substantial portion of the portability component and the treatment space. Petition 870260060944, dated 06 / 22 / 2026, p. 17 / 266 9 / 102

[0019] In a fifth aspect, the present invention provides a portable vacuum unit for a wound treatment system to provide negative pressure treatment to a wound, the vacuum unit comprising: an air inlet valve; an actuator to operate the air inlet valve between an open and a closed position; a pump comprising a pump inlet and a pump outlet; a motor to drive the pump; and a controller in communication with the actuator and the motor to operate the air inlet valve and the pump to apply negative pressure treatment to a wound, and an interface manifold comprising: A first fluid flow path with a first inlet and first outlet, the first inlet connected to the air inlet valve and the first outlet providing a vacuum unit fluid outlet for connection to an upstream side of the treatment device, and a second fluid flow path with a second fluid inlet and a second fluid outlet, the second outlet being connected to the pump inlet and the second inlet providing a vacuum unit fluid inlet for connection to a downstream side of the treatment device, an enclosure to house the air inlet valve, actuator, pump, motor, controller and interface manifold, the interface manifold being a separate assembly within the enclosure, providing an interface between the air inlet valve and the upstream side of the wound treatment device and an interface between the pump inlet and the downstream side. Petition 870260060944, dated 06 / 22 / 2026, p. 18 / 266 10 / 102 of the wound care device.

[0020] Additional features of the above aspects of the invention are set forth in the appended claims. Definitions

[0021] In this descriptive report and claims, unless the context indicates otherwise, the term exudate is intended to mean any fluid removed from a patient's wound site. Exudate may include exudate produced by the patient, and / or fluid applied to the wound site by a system, including air or treatment fluid, such as saline solution, or fluid delivering medication, etc., or through a surgical intervention that may have introduced or administered treatment fluids to the wound site via a separate route; such as injection.

[0022] In this descriptive report and in the claims, unless the context indicates otherwise, the terms fluid and treatment fluid are intended to mean liquid fluids and liquid treatment fluids, such as wound irrigation solutions. Thus, unless the context suggests otherwise, the terms fluid and liquid may be used interchangeably.

[0023] In this descriptive report and claims, the terms negative pressure and vacuum pressure may be used interchangeably to mean a gauge pressure lower than ambient pressure and an absolute pressure lower than atmospheric pressure, which may also be referred to as subatmospheric pressure or suction pressure. For example, a negative pressure or vacuum pressure of 100 mmHg is a gauge pressure of -100 mmHg or approximately 660 mmHg absolute pressure. The terms high or other similar terms, when used in relation to negative or vacuum pressure, are intended to mean higher or increasing negative pressure, for example, a gauge pressure of -150 mmHg. Petition 870260060944, dated 06 / 22 / 2026, page 19 / 266 11 / 102 (610 mmHg absolute) can be described as being higher than a gauge pressure of -100 mmHg (660 mmHg absolute). Similarly, with respect to the terms low, decrease, or other similar terms, when used in relation to negative pressure or vacuum, a gauge pressure of -100 mmHg can be described as being lower than a gauge pressure of -150 mmHg.

[0024] In this descriptive report and claims, unless the context indicates otherwise, the term NPT is intended to mean negative pressure treatment which refers to a system or apparatus that is configured to administer negative pressure or vacuum pressure to provide treatment to any internal or external wound. For clarity, a system that is configured to administer negative pressure wound therapy to an external wound is considered a type of negative pressure treatment system, given that it is a system that is configured to administer suction to an internal closed surgical site.

[0025] It can also be said, broadly, that the invention consists of the parts, elements and features referred to or indicated in the descriptive report of the application, individually or collectively, and any or all combinations of two or more of said parts, elements or features. When specific whole numbers are mentioned herein that have known equivalents in the art to which this invention relates, such known equivalents are considered to be incorporated herein as if described individually.

[0026] The term "comprising," as used in this descriptive report and claims, means that it consists at least in part of. In interpreting statements in this descriptive report and claims that include the term "comprising," features other than those preceded by this term may also be implied. Petition 870260060944, dated 06 / 22 / 2026, page 20 / 266 12 / 102 you feel. Related terms, such as comprehend and understood, should be interpreted in a similar way.

[0027] It is intended that the reference to a range of numbers disclosed herein (for example, 1 to 10) also incorporates reference to all rational numbers within that range and any range of rational numbers within that range (for example, 1 to 6, 1.5 to 5.5 and 3.1 to 10). Therefore, all subranges of all ranges expressly disclosed in this document are expressly disclosed in this document.

[0028] As used here, the term(s) after a noun signifies the plural and / or singular form of that noun. As used here, the term and / or signifies and or or, or where the context permits, both. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] The present invention will now be described by way of example only and with reference to the accompanying drawings, in which:

[0030] Figure 1 is a schematic of a negative pressure treatment system of the prior art, which is configured to treat an external wound;

[0031] Figure 2 provides a high-level schematic representation of a negative pressure treatment (NPT) system according to at least one embodiment described herein;

[0032] Figure 3 illustrates the system of Figure 2 applied to an external wound;

[0033] Figure 4 illustrates the system of Figure 2 applied to an internal injury;

[0034] Figure 5(i) is a schematic representation of a vacuum unit of the system in Figure 2. Figures 5(ii) and 5(iii) are schematic cross-sectional views of a double-lumen duct made through planes A and B of Figure 5(i); Petition 870260060944, dated 06 / 22 / 2026, page 21 / 266 13 / 102

[0035] Figure 6 is a schematic representation of the system of Figure 2;

[0036] Figure 7 is an additional schematic representation of the system in Figure 2 and is equivalent to the diagram in Figure 6, but additionally illustrating additional components of the vacuum unit of the system;

[0037] Figure 8 is a schematic representation of an alternative embodiment of an NPT system that comprises features of the system in Figure 2 and additionally includes a treatment fluid reservoir;

[0038] Figure 9 is a schematic representation of the system of Figure 8;

[0039] Figure 10 is a further schematic representation of the system in Figure 8 and is equivalent to the scheme in Figure 9, but additionally illustrating additional components of a vacuum unit of the system;

[0040] Figure 11 is a schematic representation of an additional alternative embodiment of an NPT system;

[0041] Figure 12 is an additional schematic representation equivalent to the diagram in Figure 11, but additionally illustrating additional components of a vacuum unit of the system;

[0042] Figure 13 provides two views of a pump for use in an NPT system, such as those systems described herein;

[0043] Figure 14 is a cross-sectional view of the pump of Figure 13;

[0044] Figure 15 is an exploded view of the bomb in Figure 13;

[0045] Figure 16 is another exploded view of the bomb in Figure 13;

[0046] Figure 17 illustrates the pump of Figure 13 together with an interface manifold removablely attached to a pump inlet, corresponding to the system of Figures 11 and 12. The manifold Petition 870260060944, dated 06 / 22 / 2026, page 22 / 266 14 / 102 can also be adapted for use with the system shown in Figures 9 and 10;

[0047] Figure 18 illustrates the pump and interface manifold of Figure 17 with the interface manifold separated from the pump;

[0048] Figure 19 illustrates the interface collector of Figures 17 and 18;

[0049] Figure 20 provides two views of an interface collector identical to the interface collector shown in Figures 17 to 19;

[0050] Figure 21 is a cross-sectional view of the collector of Figure 20 with the section through the collector indicated in the end views shown in the Figure;

[0051] Figure 22 is another cross-sectional view of the collector of Figure 20 with the section through the collector indicated in the end views shown in the Figure;

[0052] Figure 23 is an exploded view of the collector in Figure 20;

[0053] Figure 24 illustrates an alternative interface collector corresponding to the system shown in Figures 6 and 7;

[0054] Figure 25 is an exploded view of the collector in Figure 24;

[0055] Figure 26 is a cross-sectional view of the collector of Figure 24 with the section through the collector indicated in the end views shown in the Figure;

[0056] Figure 27 illustrates a reciprocating pump together with a motor to drive the pump;

[0057] Figure 28 is an exploded view of the bomb in Figure 27;

[0058] Figure 29 is an end view of a duckbill valve that can be incorporated into the pump assemblies described herein;

[0059] Figure 30 is a cross-sectional view through the duckbill valve of Figure 29;

[0060] Figure 31 shows a cross-section of a conduit. Petition 870260060944, dated 06 / 22 / 2026, page 23 / 266 15 / 102 dual lumen;

[0061] Figure 32 shows a cross-section of an alternating double lumen conduit;

[0062] Figure 33 provides a front view and side views of a portable vacuum unit for the system of Figures 5 to 7;

[0063] Figure 34 provides a partially exploded view of the vacuum unit of Figure 33 to reveal the interface collector of Figure 24;

[0064] Figure 35 provides an exploded view of the vacuum unit in Figure 33;

[0065] Figure 36 shows the vacuum unit of Figure 33 with a top cover of a unit enclosure or cabinet removed to reveal unit components mounted inside the enclosure, with wiring and tubing connections omitted for clarity;

[0066] Figure 37 provides a front view, a side view and a rear view of a portable vacuum unit for the system of Figures 11 and 12;

[0067] Figure 38 provides a rear view and a partially exploded view of the unit of Figure 37 with a rear cover of a unit enclosure or housing removed to reveal the interface manifold of Figure 19;

[0068] Figure 39 is a schematic representation of the system in Figures 8 to 12, including an external device for wound treatment;

[0069] Figure 40 is a cross-sectional view of the wound treatment device illustrated in Figure 39;

[0070] Figure 41 shows a supply and removal conduit arrangement to be provided together with a portability component in an external device for wound treatment, as shown in Figure 40; Petition 870260060944, dated 06 / 22 / 2026, page 24 / 266 16 / 102

[0071] Figure 42 shows an alternative supply and removal conduit arrangement to be provided together with a portability component in an external wound care device, as shown in Figure 40;

[0072] Figure 43 illustrates several flow characteristics with entrained air in a liquid flow;

[0073] Figure 44 shows a system architecture for various modes of an NPT system described herein;

[0074] Figure 45 shows a hardware architecture for various modes of an NPT system described here;

[0075] Figure 46 provides a high-level control flow diagram for various modes of an NPT system described herein;

[0076] Figure 47 provides a control flow diagram for an airflow state from the control flow diagrams in Figures 46 and 51;

[0077] Figure 48 provides a control flow diagram for a pressurized state of the control flow diagrams in Figures 46 and 51;

[0078] Figure 49 provides a control flow diagram for a holding pressure state of the control flow diagram in Figure 46;

[0079] Figure 50 provides a control flow diagram for a time-limit state of the control flow diagrams in Figures 46 and 51;

[0080] Figure 51 provides a high-level control flow diagram for various modes of an NPWT system described herein;

[0081] Figure 52 provides a control flow diagram for a holding pressure state of the flow diagram Petition 870260060944, dated 06 / 22 / 2026, page 25 / 266 17 / 102 to control of Figure 51;

[0082] Figure 53 provides a control flow diagram for a fluid flow state from the control flow diagram in Figure 51;

[0083] Figure 54 provides a control flow diagram for a rinsing cycle of the fluid flow state of Figure 53;

[0084] Figure 55 provides a graph showing the system performance of a test configuration of the treatment system;

[0085] Figure 56 is a schematic representation of another treatment system that includes both an internal wound treatment device and an external wound treatment device;

[0086] Figure 57 is a schematic representation of the system in Figure 56;

[0087] Figure 58 provides a high-level control flow diagram for various modes of an NPT system from Figures 56 and 57;

[0088] Figure 59 provides a control flow diagram for a pressurization state of the control flow diagram of Figure 46 or 58;

[0089] Figure 60 provides a control flow diagram for a holding state of the control flow diagram of Figure 46 or 58;

[0090] Figure 61 provides a control flow diagram for an airflow state of the control flow diagram in Figure 46 or 58;

[0091] Figure 62 provides a control flow diagram for a time-limit state of the control flow diagram of Figure 46 or 58; and Petition 870260060944, dated 06 / 22 / 2026, page 26 / 266 18 / 102

[0092] Figure 63 provides a control flow diagram for a dressing pressurization state from the control flow diagram of Figures 46 or 58. DETAILED DESCRIPTION OF A PREFERRED MODALITY

[0093] In the figures, similar reference numbers are used for different modalities to indicate similar features.

[0094] Figures 2 to 12, Figure 39 and Figures 56 and 57 show exemplary embodiments of negative pressure treatment systems (treatment systems, in this document) for removing fluid from a wound or for supplying treatment fluid to a wound and removing fluid from a wound.

[0095] With reference to Figure 2, at a general level, the treatment system 100 comprises a wound treatment device 3 to be situated at a wound treatment site (wound) 4, a vacuum pressure unit 2 comprising a vacuum pump assembly (e.g., pump assembly 15 in Figure 5) to apply negative pressure to the wound 4 through the treatment device 3, and a fluid collection reservoir 6 to collect the fluid returned from the wound 4.

[0096] The vacuum pressure unit (or vacuum unit) 2 is configured to position the pump assembly 15 upstream of the fluid collection reservoir 6 and downstream of the wound treatment device 3. The wound treatment device 3 may comprise a topically applied wound dressing (Figure 39), an implanted treatment device, or a combination of both in a coupled configuration (Figure 56). The fluid collection reservoir 6 is configured to include one or more air-permeable filters or air outlets 6a to maintain the fluid collection reservoir 6 and the connected conduit 5c at an ambient pressure level. Petition 870260060944, dated 06 / 22 / 2026, page 27 / 266 19 / 102

[0097] The vacuum unit 2 is fluidly coupled to the wound treatment device 3 via at least one conduit. The conduit from the vacuum unit 2 to the wound treatment device 3 may comprise a two-part conduit, with a first conduit 5b extending from the vacuum unit 2, and a second conduit 5a extending from the wound treatment device 3. The second conduit may be part of the wound treatment device 3 or may be connected to the treatment device 3 by a connector (not shown). A connector 7 is provided for fluidly coupling the first and second conduits 5a, 5b. Alternatively, a continuous conduit may extend between the vacuum unit 2 and the treatment device 3.

[0098] Topically applied dressings for use in negative pressure wound therapy applications include a substantially airtight and liquid-impermeable occlusive layer that is adhered over the wound or incision to seal the wound site for the application of negative pressure. Typically, the conduit 5a extends from the dressing, but alternatively, the dressing may have a connector to receive a conduit from the vacuum unit 2, or the occlusive layer may simply adhere and seal over the conduit.

[0099] Connector 7 may comprise a one-way valve oriented to allow fluid flow in one direction from wound 4 towards vacuum unit 2 and to prevent backflow of fluid from the pump to the wound. In alternative embodiments, a one-way valve may instead be provided within vacuum unit 2, elsewhere in conduit 5a, 5b, or as part of treatment device 3. In another alternative, treatment system 100 may be without a one-way valve between treatment device 3 and vacuum unit. Petition 870260060944, dated 06 / 22 / 2026, page 28 / 266 20 / 102

[0100] In some embodiments, the conduit(s) between the vacuum unit 2 and the treatment device 3 may comprise a double-lumen conduit with a primary lumen for the passage of fluid flowing from the wound to the pump assembly 15 and a secondary lumen. The secondary lumen may allow pressure measurement at the wound site. The secondary lumen provides the release of air and / or treatment fluids to the wound 4. However, in alternative embodiments, multiple conduits may be provided between the vacuum unit 2 and the treatment device 3, each with a single lumen.

[0101] An additional conduit 5c is provided between the vacuum unit 2 and the reservoir 6 to fluidly couple the pump assembly 15 to the reservoir 6. A connector 8 may be provided to fluidly couple the conduit 5c to the reservoir 6.

[0102] In preferred embodiments, vacuum unit 2 is a portable unit. Vacuum unit 2 may be a single-use unit intended for use on a single patient. In an alternative embodiment, vacuum unit 2 could be configured for use with multiple patients. Vacuum unit 2 comprises a (plastic) enclosure or housing to accommodate the pump assembly 15 and other components. Vacuum unit 2 comprises a user interface 14 for operating vacuum unit 2. The user interface may include controls for switching the pump assembly 15 on and off from the system 100 and may allow an operator to control parameters of a pressure treatment being applied to the wound 4, such as the level of vacuum pressure being applied or the length, size, and frequency of pressure oscillations between the upper and lower set points.

[0103] In alternative embodiments, the user interface 14 may also include controls for remotely connecting a device. Petition 870260060944, dated 06 / 22 / 2026, page 29 / 266 21 / 102 monitoring of the vacuum unit to enable data transmission to a system operator or user to assist in monitoring the treatment.

[0104] Figure 3 illustrates system 100 of Figure 2 used with an external dressing or wound treatment device 30 for an open leg wound. However, system 100 is also suitable for use on internal wound sites, as illustrated in Figure 4. Figure 4 illustrates an internal wound site located in a patient's thoracic area; however, the system can be used to treat internal wounds located in other sites, for example, to treat an abdominal wound.

[0105] With reference now to Figures 5(i) to 5(iii), together with Figure 2, the vacuum unit 2 comprises a cabinet or enclosure housing a vacuum pump assembly 15 described in more detail below, batteries (16 in Figure 7) or other power source, a vacuum unit connector 9 in fluid communication with conduit(s) 5b, 5a for supplying and receiving fluid from the wound treatment site 4, and a vacuum unit outlet connector 10 in fluid communication with conduit 5c to reservoir 6, for fluid flow from the pump assembly 15 to reservoir 6. The connectors 9, 10 are configured to couple to the ends of the respective conduits 5b, 5c and may be of any form, for example, they may comprise luer-type connectors.

[0106] In one embodiment, the vacuum unit connector 9 may comprise two one-way valves such that one one-way valve within the secondary connector 9b is oriented to allow the flow of fluids from an upstream source, such as ambient air that has been passed through a sterile filter (filter 19 in Figure 6) or from a treatment fluid reservoir (reservoir 26 in Figure 6). Petition 870260060944, dated 06 / 22 / 2026, p. 30 / 266 22 / 102 Figure 8), for wound 4. The corresponding one-way valve within the primary connector 9a is oriented to allow fluid flow in one direction from wound 4 towards vacuum unit 2. In some embodiments, the one-way valves within the primary connector 9a and connector 9b may be configured to be closed when the vacuum unit connector 9 is disconnected from vacuum unit 2. These valves are then subsequently opened to allow fluid passage when the connected vacuum unit 9 is reconnected to vacuum unit 2. Examples of known prior art connectors possessing such characteristics include needleless connectors for use within IV applications, such as the BD® MaxPlus™ needleless connectors, which allow only one fluid passage once engaged with an appropriate leur-lock connector.

[0107] The conduit 5b for fluid flow into and out of the vacuum unit connector 9 is a double-lumen conduit with a primary lumen 11 and a secondary lumen 12. The connector 9 includes a primary connector 9a that provides a fluid inlet to connect to the primary lumen 11, and a secondary connector 9b that provides a fluid outlet to connect to the secondary lumen 12 while keeping the flow from these lumens separate. The larger primary lumen 11 allows fluid to flow from the wound, through the primary connector, to the vacuum pump assembly 15. The secondary or supply connector 9b can be separated from the primary or outlet connector 9a.

[0108] The primary and secondary lumens 11, 12 are preferably provided as adjacent passages in a single body / duct along most of its length, as illustrated in the cross-sectional view of Figure 5(iii) taken at section line B in Figure 5(i). Meanwhile, adjacent to vacuum unit 2 Petition 870260060944, dated 06 / 22 / 2026, p. 31 / 266 23 / 102 and / or adjacent to the wound treatment device 3, the double lumen conduit 5a, 5b may be divided or separated into two separate members or conduits, a supply conduit comprising the secondary lumen 12 and a removal or exudate conduit comprising the primary lumen 11, as shown in the cross-sectional view of Figure 5, taken at the cut line in Figure 5(i), to facilitate coupling to the vacuum unit 2 and / or to allow the supply conduit to enter the wound or wound treatment device 3 at a different location to the removal conduit. The primary or removal lumen and conduit may be referred to interchangeably and referenced by reference number 11, and the secondary or supply lumen or conduit may be referred to interchangeably and referenced by reference number 12.

[0109] Supply conduit 12 is in fluid communication with a pressure sensor Pv to allow pressure measurement on an upstream side of the wound treatment device 3.

[0110] The vacuum unit 2 comprises an air inlet valve 18 in fluid communication with the supply conduit 12. The air inlet valve 18 is controlled so as to introduce air into the treatment system 100 to assist in lifting the fluid from the wound site 4, as described in more detail below.

[0111] As shown in Figure 5(i), the air inlet valve 18 may have an inlet to drain ambient air into the system from outside the vacuum unit enclosure 2. Alternatively, the inlet to the air inlet valve may draw air from inside the vacuum unit compartment / enclosure.

[0112] A sterile filter 19 is provided to prevent the entry of bioburden and non-sterile air into the system 100 and the wound site 4. In Figure 5(i) the filter 19 is provided at an inlet of the inlet valve. Petition 870260060944, dated 06 / 22 / 2026, p. 32 / 266 24 / 102 air 18, however, a filter may be placed elsewhere between the air inlet valve 18 and the vacuum unit fluid supply connector 9b, or between the air inlet valve 18 and the wound site 4.

[0113] Figure 6 illustrates the treatment system 100 schematically in more detail. The outer contour or casing of vacuum unit 2 is illustrated by the dashed line in Figure 6. On an upstream side of the treatment device 3, vacuum unit 2 comprises the air inlet valve 18, optionally the pressure sensor Pv and the sterile filter 19, and on a downstream side of the treatment device 3, vacuum unit 2 comprises the pump assembly 15 and, optionally, a pressure sensor Pp between the pump assembly 15 and the treatment device 3. Vacuum unit 2 may also comprise a connection manifold 20 that provides a connection interface between the conduit 5a, 5b and the treatment device 3 and vacuum unit 2. The connection manifold 20 is illustrated by the dotted line in Figure 6 and the dashed line in Figure 7 and replaces connector 9 shown in Figure 5. The manifold is described in more detail below.

[0114] Figure 7 provides a further schematic representation of the treatment system 100 equivalent to Figure 6, but additionally illustrates the vacuum unit 2 comprising a power supply (in the form of a battery or battery pack 16), the user interface 14, a controller 17 and a drive motor 13 to drive the pump assembly 15. The motor, the pressure sensors Pv, Pp and an actuator (not shown) to drive the air inlet valve 18 are in electrical communication with the controller 17. In this embodiment, the pump controller 17 includes a shortwave or longwave wireless transmission form via suitable electronic components, which are known to those skilled in the art. Petition 870260060944, dated 06 / 22 / 2026, page 33 / 266 25 / 102 technical.

[0115] Figures 8 to 12 illustrate additional embodiments of a treatment system for delivering fluid and removing fluid from a wound. The embodiments in Figures 8 to 12 include features equal to or similar to the system 100 described above with reference to Figures 2 to 7, however, they are additionally configured to deliver a treatment fluid to the wound treatment device 3.

[0116] With reference to Figures 9 to 12, the vacuum unit 2 may comprise one or more ports 25 for receiving therapeutic fluids for delivery to the wound site. The port 25 is preferably configured to be nominally closed until the passage of fluids, when disconnected from the treatment fluid reservoir 26, which subsequently opens when engaged with a luer connector. The B. Braun Medical® CARESITE™ needle-free connector provides an example of such a port.

[0117] A therapeutic agent in the form of a treatment fluid may be selectively applied to the wound treatment device 3 via the supply conduit 12. A fluid source or treatment fluid reservoir 26 may be coupled to the fluid port 25 of the vacuum unit 2, for example, via a conduit or a connection to an intravenous (IV) fluid delivery set, such as a Baxter® EMC 9608 Admin Set, B. Braun Medical® Single Chamber IV Infusion Set, similar sterile IV infusion therapy set. The treatment fluid reservoir is preferably at atmospheric pressure while connected to the treatment system.This can be achieved by using a non-vented IV infusion therapy set in combination with a flexible fluid bag, such as Baxter® Sodium Lactate (Hartmanns or sodium lactate compound) IV Bag or similar, or it can also be achieved by connecting a vented IV infusion therapy set to a rigid container. Petition 870260060944, dated 06 / 22 / 2026, page 34 / 266 26 / 102 or semi-rigid treatment fluid, such as Prontosan® Wound Irrigation Solution by B. Braun Medical®.

[0118] Exemplary therapeutic fluids include, but are not limited to, sodium lactate compound, physiological saline solution (0.9% NaCl - sodium chloride) and 0.45% normal saline solution (0.45 NaCl). Antimicrobial agents and solutions may also be applied for the treatment of infections and may contain agents such as polyhexanide (PHMB), silver nitrate, hypochlorous acid (HOCl), sodium hypochlorite, betaine, sodium hypochlorite, superoxidized water with neutral pH or any other antimicrobial solutions for wound irrigation.

[0119] Other treatment fluids may also include cell suspensions and cell-based fluids to promote wound healing. The fluid may comprise flowing gels derived from ECM and mixed with water for injections, hyaluronic acid, growth factors to aid healing, analgesic drugs such as fentanyl or morphine for pain relief, and anti-inflammatory drugs such as ketorolac or diclofenac, for example, although other fluids are contemplated and will be apparent to one skilled in the art.

[0120] Instillation of autologous or allogeneic cell-based therapies containing platelet-rich plasma, stem cells, stromal cells, keratinocytes, lymphocytes, bone marrow aspirate, serum cells, and dendritic cells may aid in wound repair and healing.

[0121] Instillation of chemotherapeutic drugs could also assist in the localized treatment of cancerous cells that may be inoperable, or could be used as a general treatment plan after excision of cancerous tissue.

[0122] With reference to modality 200 of Figures 9 and 10, a Petition 870260060944, dated 06 / 22 / 2026, page 35 / 266 The treatment fluid inlet valve 22 is selectively operable to allow fluid to flow from the treatment fluid reservoir 26 into the supply conduit 12, leading to the wound. The fluid reservoir is at atmospheric pressure. When the treatment fluid inlet valve 22 is selectively opened, the negative pressure from the pump assembly 15 applied to the wound 4 through the removal conduit 11 acts to draw fluid from the treatment fluid reservoir 26 towards the dressing or wound treatment device 3. Upon activation of the treatment fluid inlet valve 22, the controller (not shown in this figure) within the vacuum unit 2 detects a subsequent drop in vacuum pressure level at the pressure sensor(s) Pv and / or Pp and activates the pump assembly 15 to maintain vacuum pressure at a target vacuum pressure level. A control algorithm is described in more detail below.In the illustrated embodiment, the air inlet valve 18 and the sterile filter 19 are provided upstream of the therapeutic fluid valve 22.

[0123] In embodiment 300 of Figures 11 and 12, the system is without a treatment fluid inlet valve 22. System 300 may include an orifice or other flow restriction to control the amount of treatment fluid introduced into the system during negative pressure treatment. In one embodiment, the administration of treatment fluids is controlled through the use of an intravenous (IV) fluid delivery set, such as a Baxter® EMC 9608 Admin Set, B. Braun Medical® Single Chamber IV Infusion Set, or a similar sterile IV infusion therapy set that is connected to unit 2 via the fluid port 25. The flow rate of treatment fluid being introduced into the supply conduit 12 is controlled by a roller clamp on the set, which is adjusted to vary the flow restriction. Petition 870260060944, dated 06 / 22 / 2026, p. 36 / 266 28 / 102 ment within the tubing section that interfaces with the flow regulator component. In this embodiment, the fluid instillation rate can be visually verified through the drip chamber of the IV infusion set when the chamber is oriented vertically, with any additional flow adjustments made through the flow regulator adjustment. This embodiment provides a manual means of introducing a treatment fluid into the wound 4 through the wound treatment device 3.

[0124] In an alternative embodiment, the vacuum unit 2 can be connected to an infusion pump via the fluid port 25 to allow fluids to be supplied to the wound care device 3 in a selectable and controllable manner. Such infusion pump systems could include the B. Braun Medical® Vista® basic large-volume infusion pump or the BD® Alaris® Syringe Module, for example, which can controllably deliver from 0.1 ml / hour to 1,200 ml / hour of treatment fluid on an intermittent or constant fluid release basis. These systems typically offer the means to select the amount, flow rate, and frequency at which the treatment fluid is dispensed. When treatment fluid is introduced into the vacuum unit 2, the system detects the subsequent drop in the vacuum pressure level set on the Pv and / or Pp pressure sensor(s) and activates the pump assembly 15 to maintain the target system level of vacuum pressure.A control algorithm is described in more detail below.

[0125] In the embodiments of Figures 8 to 12, the vacuum unit 2 comprises a connection manifold 21 that provides a connection interface between the conduit 5a, 5b and the treatment device 3 and the vacuum unit 2 and between the vacuum unit 2 and the treatment fluid reservoir 26 through the fluid port 25. The connection manifold 21 is illustrated by the dashed line in Figures 9 to 12 and replaces Petition 870260060944, dated 06 / 22 / 2026, page 37 / 266 29 / 102 tui the connector 9 shown in Figure 8. The collector is described in more detail below.

[0126] In the 300 system embodiment of Figures 11 and 12, the vacuum unit 2 additionally includes a color sensor 24 which is electronically connected to the vacuum unit controller 17. In this 300 embodiment, the color sensor 24 is positioned along the fluid flow path between the pump outlet 15 and the outlet connector 10. However, the color sensor could alternatively be positioned along the fluid path at any suitable position upstream of the pump inlet 15.

[0127] The color sensor 24 can be beneficial for detecting a color change in the wound exudate fluid flowing through the treatment device system 3 at the wound site 4. For example, the natural color change from a first blood-rich wound exudate immediately after surgery, to a pink color of serosanguineous drainage (blood and serum) and / or to a clear serous drainage (serum only). This operation of the color sensor 24 can be enhanced by supplying filtered air upstream of the treatment device 3. The filtered air displaces the fluid to produce a readable fluid sample within this short time, similar to that of a direct aspiration of fluid from the treatment site 4 through a needle.

[0128] The inclusion of a color sensor within various modality systems that deliver treatment fluid to, and remove treatment fluid from, the wound can offer additional benefits. For example, color sensor 24 could be configured to detect the passage of treatment fluid being delivered from the treatment fluid reservoir 26 and passing through the upstream fluid path, the removal conduit 11, the wound treatment device 3, and the supply conduit 12, to the Petition 870260060944, dated 06 / 22 / 2026, page 38 / 266 30 / 102 vacuum unit 2, denoting complete saturation of treatment fluid through the connected system. In other embodiments, the treatment fluid may be combined with a color-based indicator for detecting changes in the wound in response to the presence of infection, biofilm, or other wound-based pathologies.

[0129] The modality 400 treatment system of Figures 56 and 57 is similar to modality 100 of Figure 6, but includes an additional control valve 29 for coupling to a secondary device for wound treatment. The control valve 29 is coupled to and in fluid communication with the pump inlet 15. In the configuration shown in Figure 57, an external wound care device 30 is connected to the vacuum unit 2 via an additional fluid conduit 32 to the primary lumen 11, coupling the primary wound care device 3 to the pump outlet 15 via the manifold 20. In embodiment 400, the vacuum unit 2 includes a dressing port 31 for connecting the external wound care device 30 to the pump inlet 15 via a conduit 32. The application of vacuum pressure to the external wound care device 30 is controlled by means of an actuator of the dressing pressure control valve 29.

[0130] In the 400 embodiment shown in Figure 57, the system controller is connected to the dressing pressure sensor Pd, which is positioned upstream of pump 15 and dressing pressure control valve 29 and downstream of dressing port 31, with the controller configured to supply vacuum pressure to the wound care device 30 from pump 15. The controller for this embodiment is described in more detail below.

[0131] Various components of treatment systems 100, 200, 300, 400 are now described. Reservoir Petition 870260060944, dated 06 / 22 / 2026, page 39 / 266 31 / 102

[0132] As described, the 100, 200, 300 treatment system, 400 comprises a reservoir 6 for collecting fluids removed from the wound site 4, for example, wound exudate. In a preferred embodiment, the reservoir 6 is positioned furthest from the wound and is therefore downstream of the pump assembly 15, to collect fluids removed from the wound after they have passed through the pump assembly 15.

[0133] In the embodiments shown, reservoir 6 comprises a flexible bag. Alternatively, a rigid reservoir may be provided.

[0134] Reservoir 6 comprises one or more air-permeable filters or vents 6a arranged in a reservoir wall, for example, a hydrophobic vent membrane provided over an opening in the impermeable membrane. The air-permeable filters or vents allow for the venting of gases and thus prevent pressure buildup in the reservoir, hindering effective pumping. An exemplary reservoir has eight vents 6a, each having a diameter of 8 mm and a pore size of 3 microns to support a high level of airflow passing through the system.

[0135] Blood clots, fibrin, and other solidified fluids or tissue debris can block the ventilation membranes, causing the bag to inflate with air introduced into the fluid path. This inflation can cause the bag to shift and leak fluid or can prevent the pump from generating the necessary vacuum pressure, forcing the outlet valves to open under excessive positive pressure.

[0136] To avoid these problems, a high-salt compatible poly(sodium acrylate) polymer, or other blood-equivalent superabsorbent polymers, may be added to the reservoir. Petition 870260060944, dated 06 / 22 / 2026, page 40 / 266 32 / 102 tory to solidify blood and wound fluid in the bag. These polymers are available in the form of loose particles, particles suspended within a dissolvable PVA film bag, or polymers suspended in a fabric / mesh-like medium. In the embodiment shown in Figure 56, the reservoir 6 is shown comprising two absorbent polymer bags 33.

[0137] The use of this polymer in tandem with one or more air outlets in the bag prevents inflation of the bag and allows the fluid path in the treatment system to accommodate much more air as it is introduced into the system. Pump Assembly

[0138] The vacuum pump assembly 15 will now be described with reference to Figures 13 to 16. The pump assembly 15 is driven by the motor 13, as illustrated in Figures 7, 10 and 12. The pump assembly 15 comprises an oscillating plate 52, a plurality of flexible chambers 53 (diaphragms), a plurality of pairs of flexible valves 54, 55, each pair of valves being in fluid communication with a respective flexible chamber 53, and an inlet 56 and an outlet 57 of the pump. Pump cover / inlet / outlet

[0139] The pump inlet 56 and outlet 57 are arranged on a pump cover 58. In the embodiment shown, the inlet 56 and outlet 57 are provided side by side on the pump cover 58, with the inlet 56 situated closer to an edge of the pump cover 58 and the outlet 57 positioned closer to the center of the pump cover 58.

[0140] Each of the inlet and outlet 56, 57 comprises an opening extending through the pump cover for the passage of fluid into and out of the pump, respectively. With reference to the exploded view of Figure 16, the lower side of the pump cover 58 comprises two channels - an inlet (external) channel. Petition 870260060944, dated 06 / 22 / 2026, page 41 / 266 33 / 102 61, which surrounds an (internal) outlet channel 62. The opening from the inlet 56 opens into the inlet channel 61 so that the fluid flowing into the pump through the inlet 56 flows into the inlet channel 61. The outlet opening 57 opens into the outlet channel 62 so that the fluid flowing out of the pump flows into the outlet channel 62 and out through the outlet 57.

[0141] Inlet channel 61 and outlet channel 62 are distinct and fluidly separated so that fluid cannot flow directly from one channel to the other. Valves

[0142] With reference to Figures 14 to 16, the pump comprises two pairs of valves, each pair of valves corresponding to and aligned with a respective chamber 53. Each pair of valves consists of an inlet valve 54 and an outlet valve 55. The valve support component positions the inlet valves 54 to be aligned with the inlet channel 61, so that the fluid from the inlet channel is in fluid communication with the inlet valves 54. The outlet valves 55 are each positioned to be aligned with and in fluid communication with the outlet channel 62, so that the fluid from the outlet valves 55 flows into the outlet channel 62.

[0143] Valves 54 and 55 are one-way valves to allow fluid through the valve in one direction and to prevent fluid from flowing through the valve in the opposite direction. In each pair of valves, the inlet valve and the outlet valve 54, 55 are oriented in opposite directions, so that fluid can only flow into the corresponding chamber 53 through the respective inlet valve 54 and out of the chamber 53 through the respective outlet valve 55. Petition 870260060944, dated 06 / 22 / 2026, p. 42 / 266 34 / 102

[0144] Valves 54, 55 each comprise a resilient duckbill type valve. These duckbill valves each have two opposing inclined walls, with a single slit-type opening at the apex of the two walls. Under fluid pressure between the two walls, the slit is forced open by the two moving walls, to allow fluid to flow through the valve.

[0145] With reference to Figures 29 and 30, in some embodiments, each flexible valve 54, 55 may comprise a plurality of reinforcing ribs 59 on the downstream surface of the inclined walls. These ribs 59 help to maintain the valve shape under backpressure, to reduce the chance of collapse, bending or inversion of the valve under backpressure, since a thin-walled flexible valve may otherwise be susceptible to the same. The ribs 59 provide rigidity to the walls without inhibiting the bending and opening of the valve under flow. In the embodiment shown, the ribs are substantially triangular in cross-section, but in alternative embodiments they may have other shapes. The reinforcing ribs may also stiffen the valve to reduce the occurrence of backflow in the valve direction.

[0146] With reference to Figures 13 to 16, valves 54 and 55 are supported in a valve housing 63. The valve housing comprises two parts 64, 65. The two parts are fastened together with the valves 54, 55 retained between the two parts 64, 65. Each part of the valve housing can be described as a valve support component. A flanged portion of the valves 54, 55 is compressed between the two parts of the valve housing 64, 65 to provide a seal and prevent leaks. The valve housing 63 supports the valves 54, 55 so that the inlet valves 54 are in fluid communication with the inlet channel 61, and the outlet valves 55 are in fluid communication with the outlet channel 62 and with the Petition 870260060944, dated 06 / 22 / 2026, page 43 / 266 35 / 102 valves 54 and 55 arranged in pairs to correspond to a single chamber 53, as described above.

[0147] The valve housing 63 is attached to the pump cover 58 to be fluidly sealed with the pump cover and to separate the inner and outer channels 61 and 62 and thus the inlet 56 and outlet 57 of the pump. For example, a part 64 of the valve housing 63 is ultrasonically welded to the pump cover 58. The entire pump assembly 15 is then attached to the assembly using screws to secure the valves 54, 55 inside the valve housing 63.

[0148] The pump assembly 15 comprises a fluid flow path through the pump from the pump inlet 56 to the pump outlet 57 through the inlet valves 54, chambers 53 and outlet valves 55. In the illustrated embodiments, the inlet and outlet valves 54, 55 each have a single orifice in a flow path when open.

[0149] As described above, in a preferred embodiment, the exudate reservoir 6 is downstream of the pump assembly 15. This means that wound fluid passes through the pump assembly 15. A valve 54, 55 featuring a single orifice reduces the risk of blockages in the pump assembly 15 caused by debris such as tissue debris, fibrin, blood clots, loose connective tissue, and adipose tissue (fat) returned from the wound 4 passing through and blocking the vacuum pump assembly. Other valve types, such as conical valves, comprise a plurality of smaller openings and are therefore more prone to developing valve blockages.

[0150] The single orifice of each valve 54, 55 has an area when the valve is open similar to or greater than a minimum area of ​​the fluid flow path between the pump inlet 56 and the pump outlet 57. Preferably, the open area of ​​the single orifice of each Petition 870260060944, dated 06 / 22 / 2026, page 44 / 266 36 / 102 valve 54, 55 is equal to or greater than the pump inlet area 56. Therefore, if a blockage occurs in the pump assembly, it would occur at the pump inlet 56, not at a point within the pump assembly. Preferably, the open area of ​​a single orifice is greater than the cross-sectional area of ​​the supply conduit lumen 11.

[0151] The illustrated embodiment includes duckbill valves 54, 55. However, other valves featuring a single large orifice for the pump flow path may be possible, such as a hinge valve, sling valve, check valve, cross-slot valve, and a dome valve. However, a valve consisting of a single unitary flexible element is preferred. The valves are preferably molded from liquid silicone rubber (LSR) to reduce the likelihood of a wound protein, such as fibrin, binding to the valve.

[0152] In the illustrated embodiment, the valve housing 63 comprises a through port 66 with opposing strong points for securing hoses in order to conveniently secure a fluid lumen separate from a fluid flow path through the pump assembly 15. The through port 66 and the ends may be provided in another location on the pump assembly, for example, as part of the pump cover 58, or the pump assembly may be without the through hole and the ends. The illustrated embodiment includes a port 71 for connecting a pressure sensor (Pp), for example, through a tube, to measure the pressure in the pump inlet channel indicative of the system pressure downstream of the treatment device.

[0153] In other embodiments, port 71 can be configured to connect a control valve, for example, dressing control valve 29 in embodiment 400 of Figures 56 and 57, to the pump inlet, to provide vacuum pressure to a secondary device. Petition 870260060944, dated 06 / 22 / 2026, p. 45 / 266 37 / 102 river for wound treatment 30. Alternatively or additionally, the pump cover 58 could include one or more additional ports 71 to facilitate connection with a pressure sensor and a valve. Cylinder / Piston Swivel Plate

[0154] Each pair of valves 54, 55 is in fluid communication with a respective flexible chamber 53. The embodiment shown comprises two chambers 53, corresponding to the two pairs of valves 54, 55. However, alternative embodiments may have a single chamber or more than two chambers. Preferably, the pump assembly 15 comprises two or more chambers 53 and associated pairs of valves 54, 55 so that there is always one chamber compressing and one chamber expanding.

[0155] In the illustrated embodiment, the chambers 53 are supplied integrally as a single component. The component comprises a flexible, resilient, and airtight material, such as silicone. A chamber compartment 67 supports and houses the chamber component and attaches to the valve support compartment 63 to keep the chambers 53 in alignment with their respective valves 54, 55.

[0156] The flexible chambers 53 are substantially cylindrical. Each chamber comprises an associated connector 68 projecting from a lower side of the chamber 53, which is axially movable (along the axis of the cylinder), to compress and extend the chamber 53.

[0157] In the illustrated embodiment, the connectors 68 connect to a swing plate 52, which has fastening features for attaching to the connectors of the camera 68.

[0158] The oscillating plate 52 is driven by the motor 13 (not shown in these figures) via a rotary coupler 51. The coupler 51 is fixed to a drive shaft of the motor 13 so that the coupler 51 rotates together with the drive shaft around a drive shaft. The coupler 51 has a mounting opening. Petition 870260060944, dated 06 / 22 / 2026, page 46 / 266 38 / 102 gem 70 offset from the axis of rotation of coupler 51.

[0159] With reference to Figures 15 and 16, the sway plate 52 has a central tip 69 that is received by the offset opening 70 in the coupler 51. This causes the sway plate 52 to tilt as the lateral movement of the sway plate 52 is restricted by the connections with the chambers 53 and the chamber housing 67.

[0160] The tip 69 is pivotally mounted within the offset opening 70 of the coupler 51, so that the coupler 51 can rotate relative to the sway plate 69. As the coupler 51 is driven to rotate by the drive shaft of the motor 13, the tip end 69 mounted on the coupler 51 moves in a circle around the drive shaft, causing the sway plate 52 to tilt cyclically and axially in a pendulum effect.

[0161] As the oscillating plate 52 tilts cyclically, it compresses each chamber 53 in turn, and subsequently expands each chamber 53 in turn. The compression of a chamber 53 causes the fluid present in chamber 53 to be expelled through its respective outlet valve 55, into the outlet channel 62, and through the pump outlet 57. The subsequent expansion of chamber 53 creates a vacuum within chamber 53, drawing fluid from the pump inlet 56 through the inlet channel 61 and its respective inlet valve 54 and into chamber 53. This process repeats cyclically to pump fluid from the pump inlet 56 to the pump outlet 57.

[0162] The motor 13, the coupler 51 and the swashplate 52 form a drive mechanism for actuating the expansion and compression of the chambers 53. The swashplate 52 and the coupler 51 conceal the rotary motion of the motor 13 in axial motion to expand and compress the chambers 53. Other drive mechanisms are possible, for example, a crank arm fixed to the motor shaft and a connecting rod between the chamber and the crank arm. Petition 870260060944, dated 06 / 22 / 2026, page 47 / 266 39 / 102 However, when there are two or more chambers, a motor with a coupler and swashplate is a preferred drive mechanism. In the embodiment illustrated in Figures 13 to 16, the swashplate 52 and the coupler 51 are housed in a drive mechanism housing 77. The motor 13 can be mounted in the drive mechanism housing 77 (for example, as shown in the embodiment in Figure 27).

[0163] Figures 27 and 28 show an alternative pump arrangement comprising three chambers 53 and three associated pairs of inlet and outlet valves 54, 55. The plurality of flexible valve pairs 54, 55 is provided integrally by a valve component 72. The valve component 72 comprises a flexible resilient material, such as silicone, and is mounted in a substantially rigid valve holder 73. The valve holder 73 comprises a recess having a shape corresponding to the valve component 72 for locating and receiving the valve component 72. The valve holder 73 further comprises a plurality of opening pairs 74, 75, corresponding to each pair of valves 54, 55. The two openings 74, 75 in each pair are separated by a sealing bar 76.As shown in Figure 28, the valve component 72 is located between the pump cover 58 and the valve support component 73 and is seated in the valve support 73 with the inlet valves 54 projecting into the corresponding opening 74 in the valve support 73. The valve component 72 may comprise a locating flange shape and is positioned to be contiguous with the edge of the respective opening to help locate the valve 54, 55 and prevent leaks through the assembly during operation.

[0164] Sealing bars 76 are positioned between the respective inlet and outlet valves 54, 55. Sealing bars 76 Petition 870260060944, dated 06 / 22 / 2026, page 48 / 266 40 / 102 align with a portion of the pump cover that separates the inlet channel 61 and the outlet channel 62 from the pump cover 58. When the components are assembled, the sealing bars 76 rest against the valve component between the two valves 54, 55, compressing the valve component at that moment to form a seal and prevent the fluid from bypassing the valves 54, 55 and flowing directly between the inlet and outlet channels 61, 62.

[0165] In the embodiment of Figures 27 and 28, the oscillating plate 52 has a Y shape with three arms to connect the three respective compressible chambers 53. This Y shape provides an ideal clearance in this embodiment between the oscillating plate and the other components; however, the oscillating plate may have an alternative shape depending on the number of connectors it is actuating, or it may have a substantially round shape.

[0166] The preferred pump configurations described above, with reference to Figures 13 to 16 and 27 and 28, achieve a high flow capacity at low power use, making the pump particularly useful for an NPT system and, in particular, portable NPT systems.

[0167] For example, the pump described with reference to Figures a 16 comprising two chambers has the pump characteristics as set out in Table 1. For comparison, the characteristics of a peristaltic pump are given in Table 2 below. The pump described here has a much higher flow capacity for a given power consumption. For example, at 6 V, the pump described has a flow rate of 220 ml / min at a power consumption of 0.33 W, while the peristaltic pump has a flow rate of 38 ml / min at a power consumption of 0.9 W. Table 1 - Pump described above with reference to Figures 13 to 16: Petition 870260060944, dated 06 / 22 / 2026, page 49 / 266 41 / 102 Voltage (V) l / min Current (mA) Power (W) 3.3 0.11 45.6 0.15 5 0.19 53.3 0.27 6 0.22 54.5 0.33 7.5 0.27 56.6 0.42 Table 2 - Peristaltic pump: Voltage (V) l / min Current (mA) Power (W) 3 0.015 45.6 0.48 6 0.038 53.3 0.9 12 0.033 54.5 3

[168] The pump assembly 15 is particularly beneficial in a Preferred NPT system 100, 200, 300, 400 in which the air inlet valve 18 is opened to introduce air while continuing to maintain negative pressure in the wound 4, as described in more detail below. Such system operation requires a high-capacity pump 15 to maintain negative pressure while introducing significant volumes of air into the treatment system 100, 200, 300, 400 with the air inlet valve 18 open for a significant portion of a valve open-close cycle time. Furthermore, the pump assembly 15 is particularly useful in a treatment system comprising a treatment device 3 configured to introduce filtered air to a large portion of the total volume of the treatment site 4. A preferred treatment device 3 is described below with reference to Figures 39 and 40.A high-capacity pump assembly 15 is required to move the increased amount of air and lift the fluid from wound 4 to the exudate reservoir 6 while continuing to maintain negative pressure in wound 4 at an effective negative treatment pressure level.

[0169] Prior art NPT systems configured with a vacuum pump assembly upstream of the collection reservoir Petition 870260060944, dated 06 / 22 / 2026, page 50 / 266 42 / 102 fluid and downstream wound care devices typically use peristaltic pumps, as they can handle tissue debris and provide the benefit of a closed system with fluid separated from direct contact with moving parts of the pump. However, a peristaltic pump provides insufficient capacity at a practical size and power to achieve the required negative treatment pressure and flow rates in a preferred system configuration.

[0170] A peristaltic pump that provides an adequate flow rate for the preferred system described herein would be unsuitable for portable systems due to its size and power requirements. The pump assembly described 15 allows for enhanced capacity (increased flow rate) at lower power compared to prior art pumps, while allowing biological matter such as blood, adipose tissue, fibrin, lysed cells and large biological particles (2 mm in size) to pass through the pump assembly 15 without causing obstructions.

[0171] The pump assembly 15 described may be useful in other applications requiring a pump with high output capacity for relatively low power input. For example, the pump described may be particularly suitable for use in a portable dialysis device or any other portable device where large volume movements are required, particularly in applications requiring the movement of large volumes at a pressure level above or below ambient levels. Sterile filter

[0172] The sterile air inlet filter 19 may comprise a PTFE membrane, for example, PTFE syringe-type filters available from Steriltech™. In one example, the filter 19 comprises a filter membrane pore size of approximately 0.2 µm. Petition 870260060944, dated 06 / 22 / 2026, p. 51 / 266 43 / 102 cron. The filter membrane may have an area of ​​approximately 1 cm2. The filter may comprise a filter assembly that includes an enclosure to enclose a membrane or filter element and with an inlet and outlet (e.g., filter assembly 19 in Figure 25 comprising enclosure 19a with inlet 19b and outlet 19c). A suitable filter is filter part number PT021350 supplied by Steriltech™.

[0173] Filter 19 preferably additionally provides a predetermined pressure drop between the ambient pressure outside the treatment system 100, 200, 300, 400 and the pressure in the treatment system 100, 200, 300, 400 on the upstream side of the treatment device 3. The pressure drop may be provided by a filter membrane and / or an orifice in a flow path through a filter assembly. For example, the filter is chosen to provide a pressure drop of about 20 to 130 mmHg. In an exemplary embodiment, the filter provides a pressure drop of about 100 mmHg. Alternatively, a pressure drop between the environment and an upstream side of the wound treatment device may be provided by another component, such as an orifice plate or other inlet restriction situated in the system upstream of the wound treatment device.When the air inlet valve is open, the inlet restriction determines the pressure at the wound along with the control of the pump assembly on the downstream side of the treatment device 3.

[0174] In specific embodiments where the secondary conduit 12 or the supply path of the vacuum pressure unit 2 includes a common connection between the air inlet valve 18 and the treatment fluid reservoir 26, as shown in the embodiments of Figures 8 to 12, the filter / filter element is preferably hydrophobic, to prevent clogging of the filter 19 after contact with the fluid. Petition 870260060944, dated 06 / 22 / 2026, page 52 / 266 44 / 102 treatment from treatment reservoir 26. Otherwise, any suitable type of filter media can be used.

[0175] The air filter 19 can be provided in an air inlet for the treatment system 100, 200, 300, 400 or within an air flow path of the treatment system. For example, the vacuum pressure unit enclosure can be hermetically sealed to prevent unwanted fluid entry (such as shower water or rain, etc.) into the vacuum unit 2 and provide a passage for the air inlet valve 18 through an external opening in the enclosure. In this case, a sterile filter membrane can be welded or otherwise attached to a port in the compartment to ensure that the air path to the wound is sterile and biocompatible. The disadvantage of this is that all fluid contact parts of the system, including the air inlet valve 18, need to be sterilized.

[0176] In a preferred embodiment, the filter 19 is situated between the air inlet valve 18 and the wound site, as shown in Figures 6, 7, 9 to 12, and Figure 57. This allows a non-sterile air inlet valve assembly 18 to be incorporated into the system 100, 200, 300, 400 within the vacuum unit housing and to drain ambient air to the valve 18 from the surrounding environment. When an upstream pressure sensor Pv is provided, this is preferably upstream of the filter 19 so that the sensor also does not require sterilization. Air inlet valve and fluid inlet valve

[0177] The air inlet valve 18 includes an actuator such as a solenoid in electrical communication with the controller to actuate the valve between the open and closed positions. An example of a valve suitable for use as the air inlet valve 18 is a mini-solenoid valve supplied by Koge™, part number Petition 870260060944, dated 06 / 22 / 2026, page 53 / 266 45 / 102 KSV2WM-5A. This specific solenoid valve has a central ferromagnetic piston component that remains nominally closed against an internal rubber seal through the force provided by an internal spring. This valve is opened by applying an electric current to generate a magnetic field that opens the piston against the spring force. This valve has the advantage of automatically closing upon loss of electrical current to preserve the vacuum pressure level within the treatment device 3, which is advantageous when electrical power is unexpectedly lost, for example, when the battery is discharged. The disadvantage of this valve is the total amount of energy required to keep the valve open for extended periods.

[0178] Another example of a suitable air inlet valve is the NLV-2-MFF solenoid diaphragm isolation valve supplied by Takasago Fluidic Systems (Takasago Electric, Inc.). This solenoid valve uses permanent magnets to hold the valve in the open or closed position. Supplying electrical current to the solenoid in a first direction will move the valve from an open to a closed state, while supplying electrical current in a second, reverse direction will move the valve from a closed to an open state. This latching solenoid valve requires only electrical power to change the open / closed state of the valve and therefore does not require power to maintain the valve position, unlike the KOGE™ example provided above.The lower energy demand of this valve is particularly advantageous for the 100, 200, 300, 400 treatment system described herein, where long valve timing durations can be applied by the controller. However, the energy saving advantage of this solenoid valve also presents the risk of total vacuum pressure loss in the wound treatment device 3. Petition 870260060944, dated 06 / 22 / 2026, page 54 / 266 46 / 102 in the event that energy is lost to the vacuum pressure unit 2, which can be mitigated by including a capacitor component within the electrical circuit that connects to the solenoid valve.

[0179] The air inlet valve 18 does not operate as a pressure relief valve, i.e., the air inlet valve is not controlled to open suddenly to limit pressure on the wound. The air inlet valve is opened and closed based on a predetermined time period, i.e., the control of the air inlet valve is temporal control, not pressure control, as explained in more detail below.

[0180] The fluid inlet valve 22 includes an actuator such as a solenoid in electrical communication with the controller to actuate the valve between the open and closed positions. The KOGE™ solenoid and the Takasago Fluid Communication System locking solenoid valves described above can be used for this purpose. Both valves contain moving parts that come into direct contact with the treatment fluid flowing from the treatment fluid reservoir 26 to the wound treatment device 3 through the secondary conduit 12. To be suitable for human use, it would be necessary for the fluid contact components to be manufactured from biocompatible materials while also being supplied sterilized.

[0181] In this case, the use of a throttling valve or similar non-fluid contact fluid control valve, such as the nominally closed ASCO® 390NO12330 2-way throttling valve, is desired. These throttling valves have an open channel or receptacle to receive a tube that is connected to a treatment fluid reservoir 26 such as an IV bag. An example would be the small tube contained in the Braun Medical® Single Chamber IV Infusion Set, where the throttling valve would replace the com Petition 870260060944, dated 06 / 22 / 2026, p. 55 / 266 47 / 102 Flow regulator component within the IV infusion set. In the embodiment illustrated in Figures 9 and 10, a solenoid-operated throttling valve can be applied to a tube extending between the fluid port 25 and the connecting manifold 21. A solenoid-operated throttling valve has an internal spring that ensures a ferromagnetic plunger component pinches the tube closed when the tube is inserted into the valve. The controller supplies an electrical current to an internal coil of the solenoid where the resulting magnetic force retracts the plunger against the force supplied by the spring to an open position to release the tube, thus allowing the treatment fluid to flow through the tube. The controller continues to supply electrical current to the solenoid when fluid supply is required.When the supply of treatment fluid from reservoir 26 is no longer needed, the controller stops supplying electrical current to the solenoid, which results in the piston returning to the closed position through the force applied by the internal spring. Dressing control valve

[0182] Dressing control valve 31 includes an actuator such as a solenoid in electrical communication with the controller to actuate the valve between the open and closed positions. Any suitable actuator, such as the KOGE™ solenoid and the Takasago Fluid Communication System locking solenoid valves described above, can be used for this purpose. Piping

[0183] Figures 31 and 32 show cross-sections for two double-lumen conduits for connection between vacuum unit 2 and treatment device 3. The conduit shown in Figure 31 has a circular outer wall. This conduit is preferred for wound treatments where the conduit must be subsequently... Petition 870260060944, dated 06 / 22 / 2026, page 56 / 266 48 / 102 removed without opening the wound, for example, internal wound treatment. The round or circular outer wall allows the conduit to be rotated after removal to gently release tissue adhered to the side of the conduit that may cause discomfort to the patient.

[0184] To provide a circular outer wall, the primary and secondary lumens 11, 12 are provided side by side. The secondary or supply lumen 12 has a circular cross-section, and the primary or removal lumen 11 has a crescent-shaped cross-section to partially or completely enclose the secondary lumen 12. The primary lumen 11 has a larger cross-sectional area than the secondary lumen 12.

[0185] The conduit cross-section of Figure 32 is preferred for use with or as part of a wound treatment device for treating an external wound, as described below, with reference to Figures 39 to 42. The conduit comprises a primary or removal lumen 11 and a secondary or supply lumen 12 side by side with an inner wall W separating the two lumens, and with the two lumens comprising a circular cross-section.

[0186] For example, the supply lumen may have a cross-sectional area of ​​about 1.7 mm2 and the removal lumen may have a cross-sectional area of ​​about 9 mm2. A typical tubing length between the vacuum unit and the treatment device is about 1,000 mm. In other embodiments, the cross-sectional area of ​​the supply lumen could range from approximately 0.7 mm2 to 3 mm2, with the primary lumen ranging from approximately 2 mm2 to approximately 30 mm2, with the supplied tubing length at any point from approximately 200 mm to approximately 1,500 mm. Petition 870260060944, dated 06 / 22 / 2026, page 57 / 266 49 / 102 Wound treatment device

[0187] An example of treatment device 3 for use in internal wounds is shown in Figure 7, which is similar to the treatment device shown schematically in Figure 6 comprising a single tubular flow path at the wound treatment site. Treatment device 3 provides a fluid flow path through the wound treatment site 4. Treatment device 3 includes a perforated conduit 3a having an upstream end 3b and a downstream end 3c. Fluid, for example, air, is supplied to the treatment device and the wound site through the upstream end 3b of treatment device 3. Fluid, for example, air and exudate, is removed from the wound and treatment device 3 through the downstream end 3c of treatment device 3.In the illustrated embodiment, treatment device 3 provides a single flow path through the treatment device; that is, the treatment device conduit does not include branches. In such an arrangement, where portions of the treatment device conduit are close together, a DC short-circuit path can exist, so that flow preferentially occurs between two portions of the treatment device conduit 3a that are close together. This can prevent fluid flow from reaching other areas of the treatment site, preventing flow to and from those areas.

[0188] In some embodiments, a treatment system may comprise an external wound treatment device to deliver treatment fluids and / or air and provide subsequent removal of fluids from a wound while maintaining a subatmospheric (negative) pressure environment.

[0189] Figure 39 shows a treatment system comprising an external wound treatment device 40. The uni Petition 870260060944, dated 06 / 22 / 2026, page 58 / 266 The 50 / 102 vacuum system 2 is connected to a therapeutic fluid source 26 and a wound exudate reservoir 6 via conduits and to the treatment device 40 via a double-lumen conduit 5, as previously described for embodiments 200 and 300 of Figures 8 to 12. However, the wound treatment system may be without a therapeutic fluid supply, as described for embodiment 100 of Figures 6 and 7.

[0190] Figure 40 is an illustrative cross-sectional view of the external wound treatment device 40 shown in Figure 39, where the cutaway view corresponds to the line denoted with an x ​​in Figure 39.

[0191] The external wound treatment device 40 comprises a portability component or layer 41 (wound filler), a covering dressing or layer 42, a supply conduit 12, and a removal (separate) conduit 11. The portability component 41 is shown as being placed within a wound cavity to fill a wound treatment space. The covering dressing is adhered to an area of ​​intact, uncompromised skin surrounding the wound (also known as the peri-wound). The dressing covering 42 is produced from materials that allow adhesion to the peri-wound while providing a hermetic seal, such as polyurethane film containing a pressure-sensitive acrylic adhesive layer, to allow maintenance of vacuum pressure within the wound site. Such materials are known in the art.

[0192] The treatment device 40 comprises two separate conduits 11, 12 within the wound treatment space. The conduits 11, 12 may be terminal portions of the supply conduit 12 and the removal conduit 11 extending between the treatment device 40 and the vacuum unit 2 described above. Petition 870260060944, dated 06 / 22 / 2026, page 59 / 266 51 / 102 In the example of a double-lumen duct, a terminal portion of the double-lumen duct may divide into two separate members, a removal or exudate member (the removal duct) and a supply member (supply duct).

[0193] As discussed above, the supply conduit 12 provides the supply of air, or air and fluids, to the wound, including treatment and therapeutic agents and the supply of sterile air. The removal conduit 11 provides removal of exudate fluid from the wound.

[0194] In Figure 39, both conduits 11, 12 have perforations or openings 11a, 12a of equal or different sizes to allow fluid exchange to the target treatment site. The terminal ends of the conduits may be occluded / scalded so that flow out of and into the respective conduits is through perforations along their lengths. Alternatively, the terminal ends also have an outlet and an inlet for the supply and removal conduits, respectively.The perforations are spaced along the conduit and may be placed at repeated or variable distances along the conduit to reduce a potential pressure loss that may occur along the length of the conduit. The perforations or openings 11a, 12a provide an outlet or outlets from the supply conduit 12 and an inlet or inlets to the exudate conduit 11.

[0195] The portability component or portability layer 41 may be formed from any suitable biocompatible material that can facilitate fluid flow through or around the gate layer 41, including but not limited to polyurethane foams, polyvinyl alcohol foams, nonwoven fabrics, spacer fabrics, filters, cross-linked foams, plastic mesh materials or elastomeric components constructed from silicone, thermoplastic elastomer or polyurethane that provide interpetição 870260060944, dated 06 / 22 / 2026, page 60 / 266 52 / 102 sufficient structural grit to prevent collapse of the wound dressing material under applied vacuum pressure.

[0196] A wound contact component may also be additionally placed between the wound and the carrier component to promote wound healing and may comprise extracellular matrix (ECM) graft materials such as decellularized human or animal tissues isolated from various organs and a variety of animal connective tissues and basement membrane sources. Other possible wound contact components include natural polymeric materials such as a protein, polysaccharide, glycoprotein, proteoglycan, or glycosaminoglycan. Examples may include collagen, alginate, chitosan, and silk.Alternatively, or additionally, the wound contact components may comprise synthetic polymeric materials such as polypropylene, polytetrafluoroethylene, polysiloxanes (silicone), polyglycolic acid, polylactic acid, polylecaprone-25, or polyester. The wound contact component may comprise a combination of multiple layers of one or more of the above materials.

[0197] The wound treatment space shown in the Figure is defined by the covering dressing 42 and the wound treatment surfaces of the external (open) wound. The treatment device 40 is applied to the wound treatment space to facilitate fluid supply and fluid removal from the treatment space. The treatment space contains the fluid supply conduit 12, the exudate fluid removal conduit 11, and the portability component or layer 41.

[0198] A fluid flow from the supply conduit 12 through the portability component 41 and out of the exudate fluid removal conduit 11 is indicated by the arrows in Figure 40. The portability component 41 ensures that the therapeutic fluid Petition 870260060944, dated 06 / 22 / 2026, page 61 / 266 53 / 102 and / or the supplied air are distributed to the treatment surfaces within the wound, while a negative pressure level is maintained within the wound treatment space.

[0199] As shown in Figures 39 and 40, the fluid supply conduit 12 and the exudate or removal conduit 12 are arranged to avoid or prevent a short-circuit flow path between the two conduits and through the wound treatment space. The arrangement improves fluid flow through a substantial portion of the treatment space and, preferably, substantially the entire treatment space. A short circuit can result in preferential fluid flow only to portions of the treatment space instead of fluid supply to substantially the entire treatment space.

[0200] To avoid a short-circuit path through the wound treatment space, in preferred embodiments, the two conduits 11, 12 are positioned at opposite locations in the portability layer, i.e., in adjacent perimeter portions of the portability layer and / or the wound treatment area. In Figures 39 and 40, the two conduits are placed in opposite or adjacent perimeter portions of the portability or wound treatment space. The supply and removal conduits 12, 11 are preferably positioned at a maximum distance from each other in the wound treatment space.

[0201] In the illustrated embodiment, the supply and removal conduits are placed on one side of the portability layer. However, in other embodiments, the conduits may be arranged on opposite sides of the portability layer or may be incorporated into the portability layer. When placed on a lateral surface of the portability layer (e.g., the outermost surface, the surface furthest from the wound), preferably the conduits Petition 870260060944, dated 06 / 22 / 2026, page 62 / 266 54 / 102 supply and removal ducts are provided to the portability layer so that the inlet openings 11a and the outlet openings 12a face or are placed against the surface of the portability layer 41.

[0202] In Figure 39, the supply and removal conduits 12, 11 are arranged so that there is a constant distance between the outlets 12a and inlets 11a of the respective conduits. A minimum distance between inlets 11a and outlets 12a is many times greater than a maximum distance between adjacent outlets 12a along the length of the supply conduit 12. The minimum distance between inlets 11a and outlets 12a is many times greater than a maximum distance between adjacent inlets 11a along the length of the exudate conduit 11. For example, the minimum distance between inlets and outlets may be 5, 6, 7, 8, 9, 10 times greater than the maximum distance between adjacent inlets and / or adjacent outlets.

[0203] In some embodiments, the perforations / openings 12a may be provided only in the supply conduit 12, without perforations or openings along the removal conduit 11. With reference to Figures 41 and 42, the supply conduit 12 is provided with outlets 12a along its length, as described above, and the removal conduit 11 is without inlets along its length. Fluid flow from the supply conduit 12 to the removal conduit 11 is from the outlets 12a spaced along the supply conduit 12 and an open end of the supply conduit 11, and through the portability layer 41 to the end of the removal conduit 11, as indicated by the dashed lines in Figures 41 and 42. The open end of the removal conduit 11 provides an inlet opening 11a.

[0204] Alternatively, the perforations / openings 11a may be provided in the removal conduit 11 only, without perforations or Petition 870260060944, dated 06 / 22 / 2026, page 63 / 266 55 / 102 openings along the supply conduit 12, in which case an open end of the removal conduit 12 provides an inlet opening 12a.

[0205] In a preferred embodiment, the treatment device 40 comprises a double-lumen conduit 5 comprising a supply lumen and a removal lumen. An end portion of the conduit 5 is split along its length to separate the conduit into a supply conduit portion 12 comprising the supply lumen, and a removal conduit portion 11 comprising the removal lumen. For example, the conduit shown in Figure 32 is split along its length through the inner wall W separating the two lumens without breaking at either lumen. To create openings in the side wall of the supply conduit, or the outlet conduit, cuts may be provided along the length of the conduit. For example, as shown in Figure 41, spaced notches are made through the conduit wall to break at the lumen and create an opening through the conduit wall.In the illustrated embodiment, cuts or notches are made through the inner wall W of the conduit. In Figure 42, a spiral cut is made along the length of the conduit 12 to provide a flow path along the length of the conduit. In some embodiments, given that the inner wall W of the double-lumen conduit has been separated between the two members, the inner wall may have a thinner cross-section than a portion of the outer wall of the conduit, so that the spiral cut fully penetrates the inner wall portion of the conduit without fully penetrating the outer wall portion of the conduit, to present spaced openings 12a along the length of the conduit. The embodiments of Figures 41 and 42 provide a convenient low-cost method for providing supply and removal conduits to a Petition 870260060944, dated 06 / 22 / 2026, page 64 / 266 56 / 102 wound treatment device and avoids the need for connectors. Each notch or cut preferably provides a small opening through the conduit wall, for example, for the supply conduit, an opening with a diameter of about 0.6 mm or less.

[0206] As shown in Figures 41 and 42, the treatment device may include a bridge component 43 through which the double-lumen conduit 5 passes, as described in US provisional patent application 62 / 568,914, the contents of which are incorporated herein by reference. The bridge component 43 is attached to the patient's skin and facilitates a seal between the upper cover 42 of the treatment device and the patient's skin. Collectors

[0207] As described with reference to Figures 3, 6, 7, 9 and 10, in some embodiments, the vacuum unit 2 comprises a connection manifold or interface 20, 21 for connecting the wound treatment device 3, 30, 40 to the vacuum pressure unit 2, and in the embodiments of Figures 9 to 12 and in Figure 39, for connecting the treatment fluid reservoir 26 to the fluid supply path of the vacuum unit 2.

[0208] Figures 24 to 26 illustrate the interface manifold 20 for use in the embodiment of Figures 6 and 7. The manifold 20 comprises a first fluid flow path 201 with a first inlet 202 and a first outlet 203, and a second fluid flow path 204 with a second fluid inlet 205 and a second fluid outlet 206. The first inlet 202 connects to the air inlet valve 18 and the first outlet 203 connects to the supply conduit 12 from the vacuum unit 2 to the treatment device 3. The second inlet 205 connects to the removal conduit 11 from the treatment device 3 to the vacuum unit 2, and the... Petition 870260060944, dated 06 / 22 / 2026, page 65 / 266 57 / 102 second outlet 206 connects to pump inlet 56. The first outlet 203 and the second inlet 205 provide a fluid outlet to the treatment device 3 and a fluid inlet from the treatment device 3. In the illustrated embodiment, the manifold comprises a sterile filter 19 in the first fluid path 201. In this embodiment, the sterile filter is provided as a separate assembly comprising a housing 19a and an internal filtration element with the filter housing 19a received in the first flow path 201 of the manifold 20 (omitted in Figure 26). In this way, the connecting manifold 20 provides a convenient connection interface between the system inlets and outlets in relation to the treatment device 3 while also ensuring a sterile interface for the air inlet to the treatment system 100.The illustrated embodiment also includes a one-way valve 207 in the second flow path 204 to prevent further flow in the pump's removal conduit to the treatment device.

[0209] Figures 20 to 23 illustrate the interface manifold 21 for use in the embodiments of Figures 9 to 12. The manifold 21 comprises a first fluid flow path 201 with an air inlet 202 and a treatment fluid inlet 208 in fluid communication with a first outlet 203, and a second fluid flow path 204 with a second fluid inlet 205 and a second fluid outlet 206. The air inlet 202 connects to the air inlet valve 18 and the treatment fluid inlet 208 connects to the treatment fluid reservoir 26. The first outlet 203 connects to the supply conduit 12 from the vacuum unit 2 to the treatment device 3. The second inlet 205 connects to the removal conduit 11 from the treatment device 3 to the vacuum unit 2, and the second outlet 206 connects to the pump inlet. 56. The first output 203 and the second input 205 provide an output of Petition 870260060944, dated 06 / 22 / 2026, page 66 / 266 58 / 102 fluid to treatment device 3 and a fluid inlet from treatment device 3.

[0210] In the illustrated embodiment, the manifold 21 comprises a sterile filter 19 in the first fluid path. The sterile filter 19 comprises a filter membrane received in the first fluid flow path 201. Thus, the connection manifold 21 provides a convenient connection interface between the system inlets and outlets relative to the treatment device 3 while ensuring a sterile interface for air intake to the system 200, 300. In a preferred embodiment, the manifold comprises a one-way valve 207 in the second flow path 204 to prevent backflow in the pump outlet conduit to the treatment device. The connection manifold 21 may comprise an additional one-way valve 33 in the first flow path, positioned adjacent to the sterile filter 19, to prevent the entry of treatment fluid, which would damage the sterile filter 19.

[0211] Figure 19 illustrates a collector 21a very similar to collector 21 of Figures 20 to 23. Collector 21a has the same internal features as collector 21 described above. Collector 21a is connected to a connection port 25 via a tube 27 to connect to the treatment fluid reservoir 26 external to the vacuum unit 2. Collector 21a (or 21), tube 27 and connection port 25 are preferably provided as a single sterile connection assembly for the pump unit 2. In this way, the connection assembly provides a convenient connection interface between the system inlets and outlets relative to the treatment device 3 while ensuring a sterile interface for the air inlet and treatment fluid inlet to the system 200, 300.

[0212] A pipe clamp 28 may be supplied to pipe 27 to provide a means for securing pipe 27 closed, once the Petition 870260060944, dated 06 / 22 / 2026, page 67 / 266 59 / 102 treatment fluid is no longer required. In an alternative embodiment, the pipe clamp 28 can be partially closed to provide a means of controlling a treatment fluid flow in the system, or it can be replaced by a flow regulator to provide a means of controlling a treatment fluid flow in the system. Additionally or alternatively, an orifice can be included, for example, within the pipe 27 or in the manifold 21a, to enable the Pv sensor to measure the resulting pressure drop across the orifice when the treatment fluid is flowing. The pressure measured at the Pv pressure sensor will allow the treatment fluid flow rate from the reservoir 26 to be calculated by applying Bernoulli's equation.In an alternative embodiment, the pipe clamp 28 can be replaced by an electrically actuated valve in electrical communication with the controller, for example, valve 22, as previously described with reference to Figures 9 and 10. For example, valve 22 could be a solenoid-operated valve, for example, a solenoid-operated choke-type valve, which operates a plunger inclined to a closed position by a spring. The controller 17 operates the solenoid to retract the plunger against the spring inclination to open the valve. The valve can choke the closed pipe line 27 to create a vacuum-tight seal. In some embodiments, as illustrated in Figures 11 and 12, the system may be without a controller-controlled treatment fluid valve.

[0213] Figures 17 and 18 show the manifold 21a of Figure 19 connected to the pump assembly 15, with the pump inlet 56 connected directly to the second outlet 206 of the second flow path 204 of the manifold, and the air inlet 202 of the manifold connected directly to the through spring 66 of the pump assembly 15 for connection to the air inlet valve 18. Petition 870260060944, dated 06 / 22 / 2026, page 68 / 266 60 / 102

[0214] The one-way valve 207 is preferably a resilient / flexible valve, for example, duckbill valves, as described above in relation to the one-way valves incorporated in the pump assembly 15.

[0215] The connection manifolds 20, 21, 21a preferably comprise molded parts welded or otherwise assembled together to form a fluid- and airtight assembly. The manifolds 20, 21, 21a provide connectors for fluid connection to other parts of the system, for example, tips or receptacles to be received into or to receive coupling pipe / conduits or valve / pump. The valves are preferably molded from liquid silicone rubber. Overall set

[0216] Figures 33 to 36 show general assembly drawings for vacuum unit 7 for the embodiment of Figures 6 and 7.

[0217] As previously described, the vacuum unit 2 comprises an enclosure to house the various components of the unit including the pump assembly 15 with motor 13, user interface 14, battery 16 and controller 17, air inlet valve 18 with actuator, pressure sensors Pv, Pp and sterile filter 19. In this embodiment, the vacuum unit 2 comprises the connection manifold 20 described above with reference to Figures 24 to 26. The connector 10 for communication with the collection reservoir 6 is also shown in the Figures; however, the connecting hoses or tubes / conduits between the manifold 20 and the air inlet valve 18, and between the connector 10 and the pump outlet 57, and the conduit from the manifold 20 to the treatment device 3, have been omitted for clarity. The electrical wiring is also omitted for clarity.

[0218] Figures 37 and 38 show general assembly drawings for vacuum unit 2 for the embodiment of Figures 11 and Petition 870260060944, dated 06 / 22 / 2026, page 69 / 266 61 / 102 12, including additionally the pipe clamp 28 on pipe 27 connecting the manifold 21 / 21a to the treatment fluid reservoir 26, as described above with reference to Figure 19. The illustrated embodiment is similar to the embodiment of Figures 33 to 36, however, it is additionally provided with the alternative interface manifold 21, 21a together with pipe 27, the pipe clamp 28 and the associated connection port 25 for connecting the treatment fluid reservoir 26, with the housing incorporating an opening to receive the connection port 25.

[0219] It can be seen from the two modalities of Figures 38 that the vacuum unit can be easily configured between the two modalities by choosing the appropriate interface manifold 20, 21 and an enclosure with or without an opening for the treatment fluid reservoir connection port 25. The controller for each vacuum unit modal may include a switch to configure it for the air-only modal or the modal which also includes the treatment fluid supply option. System operation

[0220] The operation of the treatment system 100 described above with reference to Figures 6 and 7 is now described with reference to Figures 44 to 50. Initially with reference to Figures 44 and 45, the system comprises the user interface 14 to allow a user to operate the system. The user interface can provide visual (e.g., LEDs) and audio indication to the user of the system settings and allows inputs, for example, one or more buttons 23 (Figure 56), for example, to turn the unit on / off, operate the pump, or select operating modes. The controller 17 provides system logic and control algorithms in electrical communication with the air valve actuator (18a in Figures 35 and 36), pump motor Petition 870260060944, dated 06 / 22 / 2026, page 70 / 266 62 / 102 and pressure sensor(s) Pv, Pp to control the air inlet valve 18 and the pump assembly 15. The controller can also communicate with the power management and sensor circuits to manage the power supply 16, for example, to provide a battery charge indication to the user through the user interface.

[0221] The controller is configured to operate the pump assembly 15 to maintain negative pressure at the wound 4 through the wound treatment device 3 while opening and closing the air inlet valve. The air inlet valve 18 is opened to introduce air into the wound site while the pump assembly continues to run to maintain negative pressure at the wound.

[0222] Negative pressure treatment can result in a stagnant system, even when the wound continues to produce exudate. In a stagnant system, the system is effectively sealed off from the environment and no fluid transfer or drainage is achieved from the wound to the exudate reservoir 6. This can exacerbate system blockages due to coagulation of blood, fibrin, etc. at the wound and / or elsewhere in the system. A blockage ultimately results in failure to achieve negative pressure at the wound, preventing negative pressure treatment.

[0223] To avoid a stagnant system, the controller opens and closes the air inlet valve 18 while continuing to run the pump assembly 15 to maintain negative pressure in the wound.

[0224] For example, the treatment system 100 is configured to open the air inlet valve 18 to introduce air into the wound site while maintaining a vacuum pressure (a first vacuum pressure) at the wound site 4 / wound treatment device 3 of at least 40 mmHg, and preferably at least 50 mmHg. In an exemplary embodiment, the treatment system Petition 870260060944, dated 06 / 22 / 2026, page 71 / 266 The 63 / 102 is capable of maintaining a vacuum pressure at the wound site / wound treatment device of approximately 50 mmHg to 100 mmHg, or approximately 60 mmHg to 100 mmHg, or 70 mmHg to 100 mmHg, or 80 mmHg to 100 mmHg, with the air inlet valve open, introducing air into the wound. When the controller closes the air inlet valve, the pump continues to operate to maintain negative pressure at the wound. With the air valve closed, the vacuum pressure at the wound site can be approximately 100 mmHg to 150 mmHg (a second vacuum pressure).

[0225] Preferably, the vacuum pressure maintained in the wound treatment device when the air inlet valve is open is at least a substantial portion of the vacuum pressure maintained in the wound when the air inlet valve is closed, or it may be equal to the vacuum pressure maintained in the wound when the air inlet valve is closed. For example, the vacuum pressure maintained in the wound with the air valve open may be approximately 30% to 100% of the vacuum pressure maintained in the wound with the air valve closed, or approximately 50% to 100%, or 70% to 100%, or approximately 80% of the vacuum pressure maintained in the wound with the air valve closed.

[0226] With the air inlet valve closed, the vacuum pressure at the wound may be about 20 to 50 mmHg higher than the vacuum pressure at the wound when the air inlet valve is open, or it may be equal to the vacuum pressure at the wound when the air inlet valve is open.

[0227] In a preferred embodiment, the system is configured to cycle the air inlet valve between the open and closed positions while continuing to maintain negative pressure on the wound. When the air inlet valve is closed, the system rapidly reverts to a stagnant state. To avoid remaining in Petition 870260060944, dated 06 / 22 / 2026, page 72 / 266 64 / 102 In a stagnant state that could lead to blockages forming, the controller is configured to reopen the air inlet valve while maintaining negative pressure at the wound, and then close the air inlet valve again. The opening and closing of the air valve continues. Introducing air into the system while maintaining negative pressure at the wound promotes fluid movement from the wound to the reservoir and reduces the risk of blockages. In some embodiments, the treatment system may be configured to continuously open and close the air inlet valve to achieve continuous pump operation to maintain fluid flow and prevent remaining in a non-flow or stagnant state for an extended period.

[0228] In a preferred embodiment, the system is configured so that, with the air inlet valve 18 open, the system reaches an equilibrium state, with an air flow rate in the treatment system through the air inlet valve 18 equal to a fluid (e.g., exudate) and air flow rate through the pump. In an equilibrium state, the vacuum pressure in the wound treatment device 3 is maintained at or reaches a constant vacuum pressure level or static state (the first vacuum pressure). The system can reach the constant vacuum pressure level after a short duration, for example, several seconds or less, for example, 5 seconds or less.In some embodiments, with the air valve open and in a state of equilibrium, the pressure drop across the treatment device is substantially zero, with substantially all the pressure drop between the system vacuum pressure and the ambient pressure occurring across the inlet restriction, provided, for example, by the air inlet filter. In some embodiments, with the air inlet valve open and in a state of equilibrium, the pressure drop across the treatment device is constant. (Introduction) Petition 870260060944, dated 06 / 22 / 2026, p. 73 / 266 65 / 102 Air induction in the wound can create a pressure drop across the entire wound site - between an upstream side of the treatment device and a downstream side of the treatment device - allowing fluid transfer from the wound 4 to the reservoir 6, thereby reducing the risk of clotting and system blockage.

[0229] With the air valve closed, the pump is controlled to maintain a negative pressure in the wound, and the flow rate from the wound to the pump is proportional to the patient's wound response; that is, the flow rate is proportional to the exudate produced in the wound. With the air inlet valve closed, the pump is controlled to maintain the vacuum pressure in the wound treatment device at a constant vacuum pressure level or static state (the second vacuum pressure). Again, the system can reach the constant vacuum pressure level after a very short duration, for example, several seconds or less, for example, 5 seconds or less. As described above, the first vacuum pressure is less than or equal to the second vacuum pressure.

[0230] The static vacuum pressure in the wound treatment device 3 with the air inlet valve 18 open may be lower than the static vacuum pressure in the wound treatment device with the air inlet valve closed. However, the vacuum pressure in the wound treatment device 3 with the air inlet valve open is sufficient for effective negative pressure treatment. As described above, the first vacuum pressure is at least a substantial portion of the second vacuum pressure and may be equal to the second vacuum pressure. Thus, the cyclical opening and closing of the air inlet valve while the pump moves to continuously achieve a negative treatment pressure not only improves exudate removal and reduces the risk of system blockages, but also Petition 870260060944, dated 06 / 22 / 2026, page 74 / 266 66 / 102 also maintains a negative pressure environment at the wound site for effective wound treatment.

[0231] Cycling the air inlet valve open and closed while maintaining negative pressure at the wound achieves a reduced fluid density at the wound site by introducing air. Often, there is a height differential at the wound site, for example, when the patient is upright or in a standing position. A height differential at the wound can result in fluid remaining static at a lower site in the wound, with drainage only in upper portions of the wound. By introducing air through the wound site, the air reaching the lower portions of the wound can lift fluid from lower portions and improve fluid movement along the wound. The introduction of air allows the system to operate much like an air pump to allow the lower density fluid to move upward or against gravity.A preferred treatment device for providing fluid flow to avoid areas of reduced or zero flow in some portions of the wound is described above, with reference to Figures 39 to 42.

[0232] The inventors have further identified a preferred mode of operation in which the air valve is operated between the open and closed positions while maintaining a negative pressure at the wound to introduce an air flow rate into the system that achieves either bubbling flow or flow in portions from the wound site to the reservoir. Figure 43 illustrates a range of flow types in a fluid comprising liquid and gaseous states. Introducing too much air due to leaving the air inlet valve open for too long can result in annular flow with exudate flowing along the inner wall of the conduit and airflow through the conduit medium. Petition 870260060944, dated 06 / 22 / 2026, page 75 / 266 67 / 102 to. This can cause the exudate to become stagnant on the conduit wall, which can lead to solidification of the fluid. A layer of solidified fluid can increase over time, leading to a blockage. By cycling the air inlet valve between open and closed, the liquid exudate can reform into a uniform column within the system's flow path when the air valve is closed, wherein the subsequent opening of the air inlet valve to introduce air results in bubbles or portions of air passing through the exudate. The air valve is closed again before an annular flow is obtained. The inventors believe this results in improved exudate removal and reduced blockages.

[0233] An example of implementing the air inlet valve cycling between open and closed during NPT is now described with reference to Figures 46 to 50. As illustrated in Figure 46, the controller is configured to implement an airflow mode or state in which the air inlet valve is open and the pump is operated to achieve a negative pressure at the wound, and a no-airflow mode or state in which the air inlet valve is closed and the pump is operated to achieve a negative pressure at the wound. In the illustrated embodiment, the no-airflow state comprises a pressurization state, a holding state, and a time-limit state.

[0234] With reference to Figure 47, in the airflow state, the controller opens the air inlet valve to allow air to enter the system on the upstream side of the treatment device and runs the pump to reach a pressure limit. For example, if the pressure detected by the pressure sensor Pp on the downstream side of the treatment device is less than a pressure limit, the controller runs the pump (turns on the pump). In other words, if the Petition 870260060944, dated 06 / 22 / 2026, p. 76 / 266 If the pressure in Pp is greater than or equal to the limit pressure, the controller shuts off the pump.

[0235] In the illustrated embodiment, the pressure limit on the downstream side of the treatment device (Pp) is a portion of a pressure limit on the upstream side of the treatment device (Pv) when the air inlet valve is closed. In the illustrated embodiment, the pressure limit on the downstream side of the treatment device (Pp) is 80% of a pressure limit on the upstream side of the treatment device (Pv) when the air inlet valve is closed. For example, when the air inlet valve is closed, the pressure limit on the upstream side of the treatment device at Pv is 100 mmHg, and in the airflow state with the air inlet valve open, the pressure limit at Pp is 80 mmHg.

[0236] The pump can switch on and off repeatedly, for example, under PID control by the controller, to maintain vacuum pressure on the downstream side of the wound treatment device with the air inlet valve open. Preferably, the system is configured to reach the limit pressure on the downstream side of the treatment device at Pp in a very short period of time, i.e., within several seconds or less, for example, 5 seconds or less. The air inlet valve remains in the open position for a period of time. When the air inlet valve is open, the pressure at the wound is kept constant. In the illustrated embodiment, the air inlet valve remains in the open position for 14 seconds. Once 14 seconds have elapsed, the controller closes the air inlet valve and the controller moves to the pressurization state from the non-airflow state.

[0237] The airflow state parameters described above are provided by way of example. In some embodiments, the system may be without the Pp pressure sensor on the downstream side of the Petition 870260060944, dated 06 / 22 / 2026, page 77 / 266 69 / 102 treatment device. The pump may be fitted with an adequate capacity so that the pump runs at a predetermined rate corresponding to a specific system performance to obtain a known or acceptable pressure level in the wound treatment device (the first vacuum pressure) with the air inlet valve open. Additionally or alternatively, the system may include a pressure relief valve to introduce air into the system at the pump inlet to ensure that the vacuum pressure generated by the pump does not increase excessively. However, in the preferred embodiment, the system includes a pressure sensor Pp and the controller operates the pump so that the pressure does not increase beyond a predetermined pressure limit, being 80 mmHg in the example above. Other pressure limits are possible depending on a desired treatment regime.Ideally, the controller implements PID control to achieve precise pump control and therefore vacuum pressure control at the wound. The controller can use either pulse width modulation (PWM) or pulse duration modulation to control the pump motor.

[0238] As shown in Figures 6, 7, 9 to 12 and 57, in the exemplary embodiments, the pressure sensor Pv is on the ambient side of the filter. The sterile filter 19 has a known pressure drop to prevent the vacuum pressure in the treatment device from retracting to ambient pressure when the air inlet valve is open. With the pressure sensor Pv on the ambient side of the filter, the sensor Pv essentially measures the ambient pressure when the air inlet valve is open. Thus, when the air inlet valve is open, the pressure detected by the sensor Pv is not used in pump control; the pump will run until the pressure detected by Pp rises above the pressure limit. In some embodiments, the pressure at Pp will not reach the pressure limit. Petition 870260060944, dated 06 / 22 / 2026, page 78 / 266 70 / 102 refers to when the valve is open. The pump can run continuously when the air inlet valve is open, however, this is less preferable.

[0239] With reference to Figure 48, in a pressurization state, the air inlet valve is closed, and the controller runs the pump to reach a pressure limit to achieve a known or acceptable vacuum pressure in the wound treatment device (the second vacuum pressure). With the air valve closed, the vacuum pressure in the wound treatment device can be increased compared to the vacuum pressure achieved in airflow mode. In the illustrated embodiment, if the pressure detected by the pressure sensor Pv on the upstream side of the treatment device is less than 100 mmHg, and the pressure detected by the pressure sensor Pp on the downstream side of the treatment device is less than 150 mmHg, the controller runs the pump. In other words, if the pressure Pv is greater than or equal to 100 mmHg or the pressure Pp is greater than or equal to 150 mmHg, the controller turns off the pump.

[0240] The system can be configured to reach the limit pressure after a very short duration of closing or opening of the air inlet valve, i.e., within several seconds or less, for example, 5 seconds or less. With the air valve closed, once the system is closed or sealed, the system reaches a stagnant condition or no-flow condition very quickly with zero pressure drop across the treatment device and therefore with the pressure at Pv = the pressure at Pp. In the illustrated embodiment, since the pressure limit at Pv is less than the pressure limit at Pp, the controller controls the pump based on the upstream pressure sensor Pv, at the lower of the two pressure limits. However, a pressure drop across the system po Petition 870260060944, dated 06 / 22 / 2026, page 79 / 266 71 / 102 of this may occur when debris and / or tissue solidification materials, such as fibrin, accumulate within the treatment device and / or pump, in which case a pressure differential may develop between the upstream and downstream sides of the treatment device as measured by the Pv and Pp sensors. System constraints may cause the system pressure to reach the upper limit on the downstream side of the treatment device before the lower limit is reached on the upstream side of the treatment device, in which case the pump is controlled based on the downstream pressure sensor Pp until the upper pressure limit at Pp is reached.

[0241] When the pressure limit has been reached, the controller shuts off the pump and moves to a holding state. The pressurization state includes a time check so that if the pump has not reached the pressure limit (e.g., at Pp) within 120 seconds, the motor is switched off and the controller moves to a time-limit state. This can occur, for example, due to a blockage within the system or another failure mode, such as a leak.

[0242] With reference to Figure 49, in a holding state, the controller keeps the air inlet valve in the closed position and continues to operate the pump to maintain the desired or acceptable vacuum pressure in the wound treatment device, switching the pump on and off, for example, under PID control, to achieve a desired pressure limit at Pv or Pp. The controller maintains the vacuum pressure with the air inlet valve closed for a period of time. In the illustrated embodiment, the air inlet valve is closed for 20 seconds. Once the 20 seconds have elapsed, the controller returns to airflow mode and the opening and closing cycle of the air inlet valve is repeated. The opening and closing of the air inlet valve can be continuously cycled. Petition 870260060944, dated 06 / 22 / 2026, page 80 / 266 72 / 102 clados to achieve the benefits described above.

[0243] The example implementation above provides an air inlet valve opening time of 14 seconds and an air inlet valve closing time of 20 seconds. These time periods are for example purposes only, and alternative time periods may be implemented. However, it should be noted that the air inlet valve is open for a substantial portion of a total opening / closing cycle. In this embodiment, the total opening / closing cycle, or cycle step, is 34 seconds, with the air inlet valve open for 14 seconds of the 34-second period, or about 40% of the total cycle. In some embodiments, the air inlet valve is open for at least 10% of the cycle duration, or at least 20% of the cycle duration, or at least 30% of the cycle duration, or at least 40% of the cycle duration.For example, the opening time of the air inlet valve may be around the same as the closing time (50% of the cycle step). In some embodiments, the air inlet valve may be open for more than 50% of the total cycle.

[0244] The system configuration exemplified above provides a cycle time of 34 seconds. However, longer or shorter cycle times are possible. As described above, it is ideal that the air inlet valve opens and closes as needed to achieve a flow in bubbles or portions from the wound site to the reservoir while maintaining negative pressure at the wound. A maximum valve cycle time can be 1 minute or several minutes. However, the air inlet valve should be open for at least approximately 10 seconds at the above pressures to ensure sufficient air is introduced into the system. The air inlet valve can remain open for 10 to 40 seconds on each air inlet valve with the cycle of Petition 870260060944, dated 06 / 22 / 2026, p. 81 / 266 73 / 102 opening / closing.

[0245] The time periods during which the air inlet valve is open and closed depend on the restriction of air inlet flow, the pump capacity, the configuration of the treatment device, and the length and diameter of the supply and exudate conduit. The system components and control parameters described above are provided by way of example. However, the inventors believe that the system parameters should be selected to allow the air inlet valve to be open for a significant duration while maintaining negative pressure in the wound at a level useful in the negative pressure treatment of a wound.

[0246] With reference to Figure 50, the exemplary embodiment includes a time-limit state to safely manage a situation in which the system is unable to reach an intended negative pressure level. As described above with reference to Figure 48, if the system cannot pressurize when the air inlet valve is closed after a predetermined time period (e.g., 2 minutes), the controller enters the time-limit state. The controller pauses pump operation for 30 seconds and increments a time-limit counter. If the time-limit counter is less than a predetermined countdown limit, the controller returns to the pressurization state to attempt to pressurize the wound treatment site. If the time-limit counter is reached, the controller returns to the air-flow state. As described above, introducing air can reduce blockages. The system may have failed to pressurize due to a blockage.Again, with reference to the airflow state, a blockage can be removed before returning to the pressurized state.

[0247] In some modalities, the treatment system may Petition 870260060944, dated 06 / 22 / 2026, page 82 / 266 74 / 102 implement other control parameters not shown in Figures 46 to 50. For example, in some embodiments, the system comprises the pressure sensor Pv on the upstream side of the treatment device and the pressure sensor Pp on the downstream side of the treatment device. The controller can operate the pump and / or the air inlet valve based on a pressure differential measured between the two pressure sensors. For example, the controller can open the air inlet valve when the pressure differential increases above an upper limit or is above an upper limit for a predetermined period of time. A system pressure differential can be indicative of a blockage in the system, especially when the air inlet valve is closed. With the air valve closed and the system in a stagnant state, the pressure on the upstream and downstream sides of the treatment device should be substantially equal.The controller can close the air valve when the pressure differential decreases below a lower limit or remains below a lower limit for a predetermined period of time. The controller can stop the pump and / or the air flow state when the pressure differential increases above an upper or maximum limit.

[0248] As described above, with reference to Figures 8 to 12, in some embodiments, the system is configured to introduce a treatment fluid into the wound. For the system in Figures 9 and 10, the controller can be configured to operate the treatment fluid inlet control valve 22 to introduce treatment fluid in a manner similar to the operation of the air inlet valve 18. The treatment fluid reservoir 26 is preferably at ambient pressure.

[0249] The controller opens the fluid inlet valve 22 while operating the pump to maintain a negative pressure in the device. Petition 870260060944, dated 06 / 22 / 2026, p. 83 / 266 75 / 102 wound treatment device to extract treatment fluid into the treatment device. In a preferred embodiment, the system is configured so that, with the fluid inlet valve 22 open, the system reaches an equilibrium state, with a flow rate of treatment fluid into the treatment system from the treatment fluid reservoir 26 being equal to a flow rate of fluid (e.g., exudate and treatment fluid) through the pump. In an equilibrium state, the vacuum pressure in the wound treatment device is maintained at or reaches a static state or a constant vacuum pressure level (i.e., a third vacuum pressure). The system can reach the constant vacuum pressure level after a very short duration, e.g., several seconds, or less, e.g., 5 seconds or less.In a preferred embodiment, with the fluid inlet valve open and in a state of equilibrium, the pressure across the treatment device is substantially zero.

[0250] When the fluid inlet valve is open, the controller can operate the pump to achieve the same pressure in the treatment device that the treatment system achieves when the air inlet valve is open.

[0251] With the fluid inlet valve closed, the pump is controlled to maintain negative pressure at the wound. With the fluid inlet valve closed, the pump can be controlled to maintain the vacuum pressure in the wound treatment device at a static state or a constant vacuum pressure level (a fourth vacuum pressure). Again, the system can reach the constant vacuum pressure level after a very short duration, for example, several seconds or less, for example, 5 seconds or less. When the fluid inlet valve is closed, the controller can operate the pump to achieve the same pressure at the device. Petition 870260060944, dated 06 / 22 / 2026, page 84 / 266 76 / 102 positive treatment that the treatment system achieves when the air inlet valve is closed.

[0252] The static vacuum pressure in the wound treatment device with the fluid inlet valve open may be lower than the static vacuum pressure in the wound treatment device with the fluid inlet valve closed. However, the vacuum pressure in the wound treatment device with the fluid inlet valve open is sufficient for effective negative pressure treatment. The treatment fluid is not introduced under positive pressure. Thus, opening and closing the fluid inlet valve during pump operation to continuously achieve a negative treatment pressure not only maintains the negative pressure environment in the wound for effective treatment but also provides treatment fluid delivery to improve treatment, exudate removal, and reduce the risk of system blockages.

[0253] The amount of treatment fluid administered to the system can be controlled based on the time the fluid inlet valve is open. A flow restriction (such as a limiting orifice) can be placed between the treatment fluid reservoir 26 and the pressure sensor Pv positioned upstream of the wound treatment device. The resulting pressure drop across this restriction can allow the fluid rate to be determined from the resulting pressure drop measured by the sensor Pv and the total amount of treatment fluid administered to be calculated. Alternatively, the treatment fluid inlet valve can be opened until a differential pressure limit is reached, or reached for a period of time, or the valve can be open for a predetermined period of time. The inlet valve for treatment fluids is preferably open when the valve of Petition 870260060944, dated 06 / 22 / 2026, p. 85 / 266 77 / 102 air intake is closed.

[0254] With reference to the embodiment of Figures 11 and 12, the system is without a controller-controlled treatment fluid inlet valve. The system administers the treatment fluid during negative treatment pressure, as the vacuum pressure in the wound draws ambient treatment fluid into the system. When the air valve is open, air flows into the treatment device, and the airflow into the system tends to interrupt the flow of fluid from the treatment fluid reservoir due to the much lower density of air compared to the density of the treatment fluid. When the air inlet valve is closed, the negative pressure in the wound draws fluid from the treatment fluid reservoir into the system and floods the wound. The treatment fluid passes through the treatment device and the wound and through the pump to the reservoir as the pump maintains a vacuum pressure in the wound.Reopening the air valve again interrupts the flow of treatment fluid and causes a pressure differential to move the fluid comprising the treatment fluid and exudate away from the wound. In this way, cycling the air inlet valve can also achieve the addition and removal of treatment fluid to and from the wound in a cyclical manner. The amount of treatment fluid added depends on how long or how much air was introduced. The amount of treatment fluid introduced into the system can be proportional to the amount of air introduced into the system.

[0255] An example of the implementation of the system in Figures 9 is now described with reference to Figures 51 to 54. As illustrated in Figure 51, the controller is configured to implement a fluid supply mode or state in addition to the airflow state described above. The controller implements a non-fluid supply mode. Petition 870260060944, dated 06 / 22 / 2026, page 86 / 266 78 / 102 Air supply / no-flow in which the air inlet valve and the treatment fluid valve are closed and the pump is operated to achieve a negative pressure at the wound. In the illustrated embodiment, the no-flow state comprises a pressurization state, a holding state, and a time-limit state.

[0256] The airflow state and the pressurization state of Figure 51 are as described above with reference to Figures 47 and 48. Once the airflow state and the pressurization state of Figures 47 and 48 have been executed, the controller implements the fluid supply hold state of Figure 52.

[0257] With reference to Figure 52, in the holding state, the controller keeps the air inlet valve in the closed position and continues to operate the pump to maintain the desired or acceptable vacuum pressure in the wound treatment device, switching the pump on and off, for example, under PID control, to achieve a desired pressure limit (in Pp and / or Pv). The controller maintains the vacuum pressure with the air inlet valve closed for a period of time, for example, 20 seconds. Once 20 seconds have elapsed, the controller switches off the pump and checks if fluid supply is required. If fluid supply is not required, the controller returns to airflow mode and the opening and closing cycle of the air inlet valve is repeated as described above with reference to Figure 46.The controller implements the fluid supply state if no treatment fluid supply has been provided for a predetermined period of time, for example, 8 hours, or a user-defined fluid supply cycle time is triggered, or if a user manually requests a fluid supply, for example, by pressing a button on the vacuum unit's user interface. Petition 870260060944, dated 06 / 22 / 2026, page 87 / 266 79 / 102

[0258] The time period between activation of the fluid supply state is much longer than the cycle time of the air inlet valve opening and closing. For example, the cycle time of the air inlet valve may be less than 1 minute and the time period between fluid supply states may be greater than 1 hour.

[0259] With reference to Figure 53, in the fluid supply state, the controller opens the fluid valve to allow treatment fluid to flow from the treatment fluid reservoir to the upstream side of the treatment device and runs the pump to reach a pressure limit. If the pressure detected by the pressure sensor Pv on the upstream side of the treatment device is less than 100 mmHg, and the pressure detected by the pressure sensor Pp on the downstream side of the treatment device is less than 150 mmHg, the controller runs the pump. Pump control when the treatment fluid valve is open may be the same as or similar to pump control when the air inlet valve is open as described above. In the illustrated example, the controller keeps the fluid valve open for 10 seconds; however, other time periods are possible.The controller closes the fluid valve and can allow a fluid dwell time to allow the fluid introduced into the wound to flood in or remain at the wound site for a defined period of time. The controller can allow user-entered information to define the dwell time between 0 minutes and 10 minutes or another time period. After the delay to allow fluid contact within the wound, the controller enters a rinsing cycle to rinse the wound treatment fluid. In the illustrated embodiment, the controller repeats the rinsing cycle three times; however, the controller can execute the rinsing cycle once, twice, or more than three times. Petition 870260060944, dated 06 / 22 / 2026, p. 88 / 266 In the illustrated 80 / 102 mode, the controller repeats the fluid supply state three times before returning to the pressurization state; however, the controller can perform the fluid supply state once, twice, or more than three times.

[0260] With reference to Figure 54, in the rinsing cycle, the controller goes through the pressurization state, holding state, and airflow state as described above, with reference to Figures 48 and 49, before continuing with the fluid supply state to repeat the fluid feed state to open the fluid valve again, if necessary, as shown in Figure 53. Upon completion of the fluid feed state, the controller returns to the pressurization state of Figure 48. The system continues to pressurize, hold pressure, and cycle the air inlet valve between opening and closing, as described above.

[0261] In the illustrated embodiment, the fluid inlet valve is opened for 10 seconds and closed for 102 seconds in each fluid inlet valve opening and closing cycle. The closing time depends on the dwell time and the combined rinse cycle execution time. In the illustrated embodiment, the fluid supply state includes three rinse cycles. With each rinse cycle requiring 34 seconds and, for example, a dwell time of zero, in the illustrated example, the fluid supply valve is closed for a total of 102 seconds. In the illustrated example, the fluid inlet valve is open for approximately 10% of the cycle duration. The fluid inlet valve may be open for at least 5% of the cycle duration, or at least 10% of the cycle duration, or at least 20% of the cycle duration.

[0262] The fluid supply and rinsing states provide a treatment fluid to the wound while maintaining negative pressure and release the treatment fluid from the wound using the Petition 870260060944, dated 06 / 22 / 2026, page 89 / 266 81 / 102 Introduction of air to remove fluid and exudate from the wound. As described above, multiple flows of treatment fluid can be provided. This procedure reduces stagnant fluid in the wound, thus reducing blockages in the system, and ensures that negative pressure is continuously applied to the wound site.

[0263] An exemplary implementation of the 400 system of Figures 56 and 57 will now be described with reference to Figures 58 to 63. System 400 comprises a first connection via a sterile interface collector connector 20 and connected conduit 5 to an implanted wound care device 3 positioned within an internal wound care site 4; and a second connection to an external wound care device 30 for positioning over a closed surgical incision 4a. Suitable external wound care devices 30 may include those well known in the art, which are configured to apply negative pressure topically across the wound 4a. This topically applied negative pressure may act to unload fixation along the primary part of the incision, for example, fixation provided by various mechanical means such as sutures, staples and / or straps.The external wound treatment device 30 is fluidly coupled to the vacuum unit 2 via a dressing port 31 through a conduit 32.

[0264] The operation of the 400 system is via the user interface 14, which allows the user to selectively operate the system. The user interface may provide visual (e.g., LEDs) and / or audio indication to the user to communicate system settings. As illustrated in Figure 56, in the 400 system, the user interface 14 includes several buttons 23 to start or stop the supply of negative pressure to the connected external wound care device 30, turn the unit power on or off, and silence the alarm. Petition 870260060944, dated 06 / 22 / 2026, page 90 / 266 82 / 102 audible and / or connect the device to a remote wireless receiving device to transmit data regarding the operation or status of the system.

[0265] Controller 17 provides system logic and control algorithms in electrical communication with the actuator for the air valve 18, the actuator for the dressing control valve 29, the pump motor 15, and the pressure sensors Pv, Pp, Pd. Controller 17 is configured to control the air inlet valve 18, the dressing control valve 29, and the pump assembly 15 based on readings from the pressure sensors Pv, Pp, Pd. The controller can also communicate with the power management and sensor circuits to manage the power supply 16 or provide a battery level warning alarm.

[0266] The controller 17 is configured to operate the pump assembly 15 to maintain negative pressure on the internal wound 4 through the implanted wound treatment device 3 while opening and closing the air inlet valve 18. The air inlet valve 18 is opened to introduce air into the wound site while the pump assembly continues to run to maintain negative pressure on the wound as described elsewhere within this descriptive report. Additionally, the controller 17 is configured to open the dressing control valve 29 for negative port pressure generated by the pump assembly 15 to the fluidically connected external wound treatment device 30 positioned over the external wound 4a.

[0267] As described herein, in relation to other system modalities, negative pressure treatment can result in a stagnant system that can exacerbate system blockages due to blood clotting, fibrin, etc., at the wound and / or other site in the system. A blockage ultimately results in failure to achieve Petition 870260060944, dated 06 / 22 / 2026, page 91 / 266 83 / 102 negative pressure on the wound, reducing the effectiveness of negative pressure therapy.

[0268] As illustrated in Figure 58, the controller 17 for the system 400 comprises a first control system for the implanted primary wound treatment device 3, and a secondary control system for the secondary external wound treatment device 30.

[0269] In an illustrative embodiment of the 400 system, the controller 17 is configured to operate the pump assembly 15 to achieve a vacuum pressure level of 100 mmHg at the valve pressure sensor Pv in the pressurization state when the system is first switched on. This vacuum pressure level is also called the target pressure level 1 at the Pv pressure sensor (see Figure 59). Once the 400 system reaches the target vacuum pressure, the system switches to the holding state illustrated in Figure 60. In the holding state, negative pressure can continue to be applied to the external wound treatment device 30, depending on the operating mode specified by a user.

[0270] With reference to Figure 63, the dressing pressurization state is configured to operate the dressing valve 29 to ensure that a vacuum pressure between 70 mmHg and 95 mmHg is supplied to the external wound site 4a, as measured by the dressing pressure sensor (Pd) between the dressing control valve 29 and the dressing connection port 31. This state continues to operate simultaneously while the primary control of the wound care device is in the hold state.

[0271] As illustrated in Figure 60, the retention state is configured to maintain the internal wound care device 3 at the primary target pressure, in this example, the target of 100 mmHg when measured in Pv, ​​with a maximum pressure of 150 Petition 870260060944, dated 06 / 22 / 2026, page 92 / 266 84 / 102 mmHg being supplied at the pump pressure sensor Pp. System 400 is held in the holding state for a predefined period, in this example, a duration of 120 seconds. After the predefined period, the system advances to the airflow state illustrated in Figure 61, unless the vacuum pressure level of Pv is below 60 mmHg.

[0272] The airflow illustrated in Figure 61 is similar to the process illustrated in Figure 47. In this example, the controller is configured so that the pump pressure Pp is directed to a vacuum pressure level of 80 mmHg when the air inlet valve is open. As for the other embodiments described above, the air valve is configured to be held open for 14 seconds, after which the air inlet valve is closed when the system changes to the pressurization state. Furthermore, as described in relation to other embodiments, the air inlet valve may be open for 10 to 40 seconds in each air inlet valve opening / closing cycle, or may otherwise vary in opening time durations or be configured to detect the equivalent length of duct that is connected to the device.

[0273] In this mode, the controller is configured to adapt to anticipated changes that may occur in response to changes occurring at the wound treatment site 4 and the implanted treatment device 3. As the primary treatment device undergoes repeated cycles through pressurization, retention, and airflow states, a pressure differential between the Pv and Pp pressure sensors has been found to occur in response to changes at the treatment site 4 and / or the implanted wound treatment device 3 as a result of tissue growth, accumulation of wound debris, and many other factors. Petition 870260060944, dated 06 / 22 / 2026, page 93 / 266 85 / 102 other factors.

[0274] In response to these dynamic changes, the system adjusts the target pressure level being applied to the Pv pressure sensor during the pressure site to compensate for changes in the treatment device 3. For example, if the motor has stopped as a result of the Pp pressure sensor being above 150 mmHg, the system will decrease the target vacuum pressure level from target pressure 1 (100 mmHg) being applied to the Pv pressure sensor by a factor of 10 mmHg to a target pressure 2 of 90 mmHg before proceeding to the holding state. If the pressure drop across the implanted treatment device 3 increases again, the system will continue to decrease the target level by a whole number until the Pv pressure level reaches a pressure below 60 mmHg (target 5).Once the pressure level measured by the Pv pressure sensor reaches this level, the system will interrupt the transition from the holding state to the airflow state, reverting the system to a continuous vacuum pressure level system.

[0275] If the vacuum pressure level at Pv returns to 90 mmHg (target 2), after a drop below 60 mmHg (target 5) during the holding state, the system will continue advancing to the airflow state where the cycle between holding, airflow and pressurization will be resumed.

[0276] The time-limit state as described in Figure 62 is largely similar to that in Figure 50, except that the system is paused for 120 seconds before the state is advanced to the pressurized or air-flow state. Specific system operation for an external wound care device.

[0277] Again with reference to Figures 9 to 12 and 39, in which vacuum unit 2 is connected to a therapeutic fluid source Petition 870260060944, dated 06 / 22 / 2026, p. 94 / 266 86 / 102 tico 26 and a wound exudate reservoir 6 through the respective conduits, and a treatment device 3 through a double lumen conduit 5. In some embodiments, the wound treatment device 3 may be an external wound dressing 40 (Figure 39), and the wound treatment system 200, 300 may not include a therapeutic fluid supply 6 (as also described for embodiment 100 of Figures 2, 3, 6 and 7).

[0278] Such systems can be configured to periodically open the air inlet valve 18 to introduce filtered air into the external wound treatment device to achieve an initial vacuum pressure level in the absence of a therapeutic fluid supply. The user interface 14 of the vacuum unit 2 can optionally be configured to provide a means of adjustment, such as a button and / or other suitable user input, and a corresponding indicator such as a graphic scale and / or LED indicator light that allows the user to adjust the opening time of the air inlet valve to compensate for the level of exudate produced for any given wound and corresponding dressing size.

[0279] The exudate produced, and therefore the opening times for the air inlet valve 18, may vary depending on the size of the wound, the type or the progress of healing. For example, a small wound requiring a 10 cm x 10 cm dressing to cover the wound area with a low amount of exudate may be expected to produce approximately 30 ml of wound exudate in a day1.

[0280] In an exemplary embodiment of the system, a 100 cm length of double lumen conduit 5 with a supply conduit 12 having an internal diameter of 1 / 16 (ID of 01.6 mm) and an exhaust conduit 11 having an internal diameter of 3 / 16 (04.8 mm) will contribute 20 cm3 of volume to the total free volume occupied Petition 870260060944, dated 06 / 22 / 2026, page 95 / 266 87 / 102 padded by the system. The total free volume is defined as the volume occupied by the internal conduits and the volume occupied by the wound treatment device 40. If a low-profile non-adherent dressing system, such as those disclosed in applicant US application no. 63 / 280787, is applied to the wound with a total dressing height of 5 mm, the volume occupied by the portability layer 41 of the treatment device 40 will be approximately 50 milliliters (50 ml), yielding a total system volume of 70 ml for this example.

[0281] In one embodiment, vacuum unit 2 is configured to supply pump assembly 15, 3.3 V. This produces a free flow rate of 178 ml / min of air, and an air inlet valve cycle time of at least 23.6 seconds is required to supply the 70 ml or 70 cm3 required volume of filtered air calculated for the example above, to displace the system fluid during a single cycle through the air flow state.

[0282] In an alternative embodiment, the dressing utilizes an open-cell cross-linked polyurethane foam component (such as Granufoam®) for the portability layer to treat the 10 cm x 10 cm wound described above, the volume occupied by the portability layer of the treatment device will be approximately 98.7 cm3 for the same size wound (composed of 78.7 cm3 of foam + 20 cm3 of the conduit). The Granufoam™ PU foam material was found to contract from 100 mm x 104 mm x 25 mm to 82 mm x 96 mm x 10 mm when the wound treatment space is subjected to -150 mmHg vacuum pressure. This would require a valve opening time of approximately 33.3 seconds (~about 10 seconds longer).

[0283] In a further example, it can be expected that a larger wound requiring a 25 cm x 25 cm dressing to cover the Petition 870260060944, dated 06 / 22 / 2026, page 96 / 266 88 / 102 wound and with a high amount of exudate produces approximately 1,750 ml in a day1. If the same vacuum unit 2 of the system and apparatus embodiment for wound treatment, as described above, is applied to the wound, a total system volume of 332.5 ml requires an air inlet valve cycle time of at least 112 seconds to deliver the 332 cm3 (332 ml) of filtered air volume needed to displace the fluid during a single cycle through the air flow state.

[0284] In this example, it may also be advantageous to provide a user interface 14 that gives the user an option to increase the frequency of airflow cycles on a given day to manage the high level of exudate in the wound, where this example would require at least 6 cycles within a 24-hour period to handle 1,750 milliliters of exudate produced.

[0285] In some systems where the primary dressing is an external wound dressing, the vacuum unit 2 may be connected to a therapeutic fluid source 26 as described previously for modalities 200 and 300 of Figures 8 to 12. In such modalities, the user interface 14 may provide input means to enable a user to adjust the volume of fluid dispensed to compensate for the total system volume of the wound care system 40.

[0286] In such an embodiment, the user interface 14 of the vacuum unit 2 could provide a means for adjusting the dressing volume in a separate adjustment from that of the exudate level produced in the wound. The user interface 14 may include a button that allows a user to set the free volume of the system, for example, by pressing and holding a button to draw fluid through the system at an adjusted vacuum pressure level, such as 30 mmHg. The vacuum pressure level set to introduce and maintain the fluid inside Petition 870260060944, dated 06 / 22 / 2026, page 97 / 266 The 89 / 102 system can be set anywhere from 10 mmHg to 200 mmHg, but is most preferably between 10 mmHg and 125 mmHg.

[0287] The user interface 14 of vacuum unit 2 may additionally provide a means for adjusting the dwell time for any instilled fluid to be held within the treatment device 40. The dwell time may be specified as any period of time, but the maximum preference is a duration between 1 minute and 30 minutes. The pump unit 2 may additionally include a means for oscillating the vacuum pressure level from the first fluid instillation pressure level to a second pressure level, including the duration of time spent at a first pressure level and a second pressure level.

[0288] Other variables that may be useful to adjust via the vacuum unit user interface 14 include the pump switching operating mode between an oscillating pressure mode to a supplied continuous vacuum pressure mode, or adjusting the elapsed time at each vacuum pressure level.

[0289] Other variables that may be useful for adjustment will be known to those skilled in the art. Example modality

[0290] The effectiveness of a treatment system for removing fluid from a wound according to the present invention is illustrated by an exemplary system configuration now described.

[0291] The bomb described above (with reference to Figures 13 to 16) comprising two chambers was connected to a 1 l container. The pump was driven by a 12 V DC motor at a maximum current of 0.25 Amp to apply a vacuum pressure to the container, and the vacuum pressure in the container was measured to obtain fluid and pressure-related properties for the pump. Petition 870260060944, dated 06 / 22 / 2026, page 98 / 266 90 / 102

[0292] The characteristics of the pump in this test are summarized in Table 1 below: Table 1: Pump characteristics Approximate drive motor voltage and RPM at no load. Average pressurization rate from 40 mmHg to 100 mmHg - container filled with water: 3.3 V 1,100 0.9 mmHg / s; 6 V 1,900 1.4 mmHg / s; 9 V 2,800 1.6 mmHg / s Table 1: continued- Average pressurization rate of 40 mmHg to 100 mmHg - container filled with air. Water flow rate: 0.7 mmHg / s 110 ml / min 178 ml / min; Air flow rate: 1.3 mmHg / s 220 ml / min 347 ml / min; 1.8 mmHg / s 330 ml / min 519 ml / min

[0293] System components: • 0.22 micron filter with a filtration area of ​​58 mm² (Steriltech part PT021350) • Air inlet valve - Mini Solenoid Valve (KOGE part no. KSV2WM-5A) - nominal voltage = 4.5 V DC, maximum current 225 mA • Effective inner diameter of wound treatment device = 3.7 mm • Effective tube length of wound treatment device = 470 mm • Internal volume of wound treatment device = 5.1 ml • Tube perforations of wound treatment device = two parallel rows of perforations arranged along the effective length of the tube, 1.5 mm between adjacent perforations and 2 mm between the two parallel rows, each perforation 0.5 mm in diameter ± 0.2 mm Petition 870260060944, dated 06 / 22 / 2026, page 99 / 266 91 / 102 • Effective internal diameter of removal duct = 3.4 mm • Length of removal duct = 1,000 mm • Internal volume of removal duct = 9.1 ml • Internal diameter of air supply duct = 1.45 mm • Length of air supply duct = 1,000 mm • Internal volume of air supply duct = 1.7 ml • Total system volume (volume of treatment device, volume of removal duct and volume of supply duct) = 16 ml. • Duct between the pump collection tank and the exudate ID = 3.2 mm • Duct length between the pump collection tank and the exudate = 300 mm • Air outlets from the tank = eight of 0.45 micron each with passages of ~8 mm in diameter.

[0294] The components of the above system were configured according to the system configuration of Figures 6 and 7, with the wound treatment device supplied in a flexible bag containing 20 ml of fluid to represent a wound treatment space. The system performed 3 cycles of opening and closing the air inlet valve. Three cycles were repeated at different times of opening and closing cycles of the air inlet valves.

[0295] In the airflow state with the air inlet valve open, a pressure of 50 mm to 90 mmHg was maintained in the treatment device, with a pump pressure of 80 mmHg to 90 mmHg. In the holding state with the air inlet valve closed, a pressure of 100 mmHg was maintained in the treatment device and in the Petition 870260060944, dated 06 / 22 / 2026, pp. 100 / 266 92 / 102 pump.

[0296] The amount of fluid remaining in the container was measured after three cycles of opening and closing the air inlet valve. The system was then left running for 15 minutes with the air inlet valve continuing to be opened and closed, and the fluid remaining in the container was measured again. The test results are presented in Table 2 below. Table 2: Test results Air flow time (air valve open) [s] Retention time (air valve closed) [s] Percentage of air inlet valve open cycle Remaining fluid after 3 cycles [g] Remaining fluid after 15 minutes [g] 2 120 1.6% 5.1 3.6 2 10 17% 5.1 1.5 14 10 58% 2.2 ,2

[0297] A significant benefit of the system illustrated by the test is the effective removal rate of substantially all the fluid from the system through cycling the air inlet valve open and closed and with the air inlet valve open for a significant portion of the cycle time. In this test, effective fluid removal was greater when the air inlet valve was open for a significant portion (58%) of the cycle time period. Further testing indicated that further increases in the air inlet valve opening time did not result in further improvements in the system's effectiveness in removing fluid.

[0298] It is assumed that an important factor in the effectiveness of the system for removing fluid from the wound is a ratio between the volume of air introduced into the system in each cycle of the air inlet valve and the volume of the system, while continuing to cycle the air inlet valve open and closed and maintaining vacuum pressure in the wound at effective negative pressure treatment levels. The volume of air li Petition 870260060944, dated 06 / 22 / 2026, page 101 / 266 93 / 102 flow through the system in each valve cycle must be at least a substantial portion of the treatment system volume. The treatment system volume is defined as the combined internal volume of the supply line, the treatment device, and the return line, for example, the system volume from the inlet restriction (the inlet filter) to the pump inlet.

[0299] To determine the volume of air added to the system during an inlet valve cycle, the same test setup described above was used, but with an inlet filter area of ​​12.5 mm2 and a 4.8 mm diameter tube of 1.5 m length representing the supply conduit, the treatment device and the return conduit, presenting a system volume of 27 ml. The system performance is illustrated by the graph presented in Figure 55.

[0300] With reference to Figure 55, with the air inlet valve closed, the volumetric air flow rate during the Hold State is 0 l / min. As the air inlet valve opens to transition the system to the Air Flow State, the pressure at the upstream pressure sensor (Pv) drops to approximately 0 mmHg, or ambient pressure levels. The pump is controlled to maintain 80 mmHg at the downstream pressure sensor (Pp) during the Air Flow State. The Air Flow State is operated for a duration of 14 seconds. Following the Air Flow State, the air inlet valve is closed and the system changes to the Pressurization State where the volumetric air flow rate rapidly decreases to 0 LPM with the pump controlled to reach 100 mmHg at the Pv pressure sensor. The cycle continues with an additional Hold State.

[0301] During the Air Flow State, the volumetric air flow rate reaches an equilibrium of approximately 0.111 LPM, or 111 ml / min, after approximately 3.7 seconds of opening. Petition 870260060944, dated 06 / 22 / 2026, page 102 / 266 94 / 102 of the air inlet valve. Over the total duration of the 14-second Air Flow State, the system achieves an average air flow rate of 106 ml / min, which equates to 25 ml of air being released through the system. The system has a volume of 27 ml. Therefore, the volume of air released through the system in a single 14-second air flow cycle is approximately 75% of the internal volume of the treatment system. Increasing the air inlet valve opening time from 14 seconds to 16 seconds would deliver approximately 28 ml of air through the treatment system, which equates to approximately 100% of the internal volume of the treatment system.

[0302] With regard to the example configuration above comprising a total internal volume of 16 ml, it is expected that, for the same system operation, a similar air flow rate would be achieved during the valve open duration of 14 seconds, resulting in a total volume of approximately 25 ml of air being released through the system. This air volume is equivalent to approximately 150% of the treatment system volume. It is suggested that the air volume supplied to the system should be at least 50% of the total system volume, or at least 60%, or at least 70%, or at least 80%, or at least 90%, or at least 100% of the total system volume. However, testing shows that several air flow cycles are required to remove ~99% of the fluid contained in the treatment site, as indicated by the results presented in Table 2 above. It should be noted that the inlet valve needs to be opened and closed.If the air inlet valve remains open continuously, or is open for an excessive period of time, an annular flow may result. Furthermore, having the air inlet valve open continuously can result in continuous pumping, which is undesirable for a portable system. It is suggested that the volume... Petition 870260060944, dated 06 / 22 / 2026, p. 103 / 266 95 / 102 The maximum air released through the system in one valve cycle is less than 200% of the total system volume, or is less than 300% of the total system volume, or is less than 400% of the total system volume. Simulated Blocking Test

[0303] A series of experiments were carried out to compare the blocking characteristics of several commercially available medium to large-sized diaphragm pumps, in comparison with the pump described below and with reference to Figures 13 to 16. The test pump device comprised an inlet 56 with an outer diameter of 06.8 mm and an inner diameter of 03 mm, and a pump outlet 57 with an outer diameter of 04.6 mm and an inner diameter of 03 mm. The pump inlet channel 61 was connected to two fluid-connected inlet valves 54 with two separate chambers 53 with the outlet flow path comprising two fluid-connected outlet valves 55 with the outlet channel 62 and the pump outlet 57.The two inlet valves 54 and two outlet valves 55 comprise duckbill valves molded from liquid silicone rubber (LSR) with a total height of 5 mm and an internal opening of 2.8 mm, leading to a tapered valve opening at the valve apex, positioned at the furthest distance from the valve inlet opening. The overall valve assembly is comparable to the cutaway view shown in Figure 14.

[0304] The table below describes the performance characteristics of the three commercially available diaphragm pumps that were tested. Petition 870260060944, dated 06 / 22 / 2026, page 104 / 266 96 / 102 Table 1: Commercially available diaphragm pumps Manufacturer Model Rated Voltage (V) Rated Current (mA) Free Water Flow Rate (l / min) Inlet Outer Diameter (mm) Approx. Inner Inlet Diameter* (mm) Kamoer® Fluid Tech (Shanghai) CO. LTD. KLC-A DC 12 <220 > 1.0 06.5 05.1* Xiamen AJK™ Technology CO. LTD. AJK- B2713 DC 12 <400 > 1.0 06.1 ±0.3 04.4* Xiamen AJK™ Technology CO. LTD. AJK- B3204 DC 12 < 500 > 1.8 08 ±0.3 06.6* * Assumes an inlet overhang wall thickness of 0.7 mm

[0305] The test medium was prepared by combining and stirring 30 grams of chia seeds with 300 grams of water (300 ml) and leaving it to thicken for at least 12 hours, allowing the chia seeds to soak and soften.

[0306] Chia seeds are typically small, ellipsoidal-shaped seeds that measure 2.15 mm x 1.40 mm x 0.83 mm on average when dry2 and absorb significant amounts of liquid to produce a polysaccharide-based gel3 that appears to form a sticky, gelatin-like substance that shows similarities to a fibrin or fibrinogen blockage when passed through a system.

[0307] For each test, a suitable tube connected one inlet of each diaphragm pump to a glass beaker filled with chia seed gel with a suitable outlet tube returning the chia seeds to the same glass beaker. The chia seed gel was pulled through the pump for several minutes where the absence Petition 870260060944, dated 06 / 22 / 2026, page 105 / 266 97 / 102 of chia seeds passing through the outlet was observed as a blockage. Each of the three commercially available diaphragm pump devices is blocked in less than one minute of testing, as shown in the table below. Table 2: Blockage test results for the three commercial diaphragm pump devices Manufacturer Model Simulated Blockage Test Result Kamoer® Fluid Tech (Shanghai) CO. LTD. KLC-A Blocked (FAILED) Xiamen AJK™ Technology CO. LTD. AJK-B2713 Blocked (FAILED) Xiamen AJK™ Technology CO. LTD. AJK-B3204 Blocked (FAILED)

[0308] The test pump described here continues to release the chia seed gel into the test beaker for several minutes during the test, indicating a PASS result. Studies in Animals

[0309] A series of animal studies was conducted to compare the effect of various valve cycle times on clinical outcomes for seroma prevention within a model of unilateral ovine external abdominal oblique dead space seroma.

[0310] Animal studies used an implanted wound treatment device 3 similar in shape to that illustrated in Figure 56. The implanted wound treatment device 3 comprised a perforated central conduit 3a approximately 260 mm long comprising a repeating row of four perforations sized 0.5 mm ± 0.2 mm spaced approximately 2 mm apart along a central conduit 3a with an approximate internal conduit area of ​​18 mm2 (inner tube diameter of 0.48 mm). The implanted wound treatment device had an outer diameter of approx. Petition 870260060944, dated 06 / 22 / 2026, page 106 / 266 98 / 102 approximately 120 mm with an inner diameter of approximately 60 mm.

[0311] A removal conduit 11 of approximately 1,000 mm in length with an internal diameter of 3 / 16 (ID 04.8 mm) was connected to a downstream end 3c of the perforated central conduit 3a, with a supply conduit 12 of approximately 1,000 mm in length with an internal diameter of 1 / 16 (ID 01.6 mm) connected to an upstream end 3b of the central conduit 3a.

[0312] Each implanted wound treatment device was connected to an externally mounted vacuum device 2 constructed to reflect the modality treatment system 100 represented in Figures 6 and 7, with the treatment algorithm as described above in relation to Figures 46 to 50.

[0313] The external vacuum pump device 2 connected to this implant 3 was configured to open the air inlet valve for 14 seconds, with the closed duration time varying to evaluate the difference in clinical outcomes associated with varying retention lengths. Tests were performed with a valve closure time of 20 seconds, 120 seconds, 240 seconds, and 360 seconds in the RETENTION STATE.

[0314] The system was maintained at a vacuum pressure level of mmHg during the instillation of filtered air during the AIR FLOW STATE with the system returning to a second equilibrium pressure of 100 mmHg during the PRESSURIZATION STATE. This cycle operated in a continuous pattern with the vacuum pressure level along the fluid removal conduit 11 capped at 150 mmHg as a safety mechanism.

[0315] The tests were carried out on five sheep, with each animal receiving a single wound treatment device. Petition 870260060944, dated 06 / 22 / 2026, page 107 / 266 99 / 102 implanted 3. A damage site of approximately 110 cm2 in the area was created by removing approximately 60 grams of external abdominal oblique muscle from a weakened area above the muscle. The implant device was positioned on the most inferior ventral aspect of the damage site and was fixed to the treatment site using a series of passed sutures that were tied to secure the implant in place. The removal conduit 11 and the feeding conduit 12 both exit the wound on the most ventral superior and cranial aspect of the wound, with the conduits held in place in the skin portal using fixation sutures. Once the treatment site was closed, the implant device was connected to the externally mounted vacuum pump device 2 to operate as programmed.

[0316] An ultrasound assessment was performed 7 days after surgery to evaluate the size of any seroma formation at the site of the injury, where the volume of any seroma measured at the site of the injury was calculated using the formula to determine the volume of an ellipsoid.

[0317] The volume of wound exudate collected within the device reservoir was measured daily to determine the total amount of fluid collected over the 7 days following surgery. All animals were sacrificed 14 days post-surgery to perform a crude assessment of the treatment site; except for Animal ID 5, which was sacrificed 7 days post-surgery. The results of the animal study are shown in the table below. Petition 870260060944, dated 06 / 22 / 2026, page 108 / 266 100 / 102 Table 1: Results of the animal study. Animal ID Valve Closed Time (seconds) Animal Weight (kg) Resected Muscle Weight (grams) Seroma Volume on Ultrasound 7 Days After Surgery (ml) Total Exudate Collected After 7 Days (ml) Seroma Observed After Euthanasia 1 20 62 71.0 0 369.9 No 2 20 60 61.8 0 280.3 No 3 120 61 63.5 0 188.9 No 4 360 63 58.9 156.2 736.2 Yes, Large 5 240 59 57.8 4.6 306.2 *Yes, Small * Euthanasia performed 7 days after surgery.

[0318] There was no sign of any seroma or wound fluid at the site of injury for animals ID 1, 2 and 3 after euthanasia 14 days after surgery, with the implanted wound treatment device 3 found to be completely integrated into the surrounding tissue.

[0319] There were moderate signs of a seroma at the site of injury for Animal 5, which was sacrificed 7 days after surgery, with the result also consistent with the ultrasound assessment at the same time.

[0320] The injury site of Animal ID 4 was found to have a large seroma 14 days after surgery, which was consistent with ultrasound findings 7 days after surgery with virtually zero signs of any integration of the separate tissue planes at the injury site.

[0321] The results of this animal study support the conclusion that an air inlet valve closure time of 120 seconds or less is more likely to lead to complete closure. Petition 870260060944, dated 06 / 22 / 2026, p. 109 / 266 101 / 102 of the dead space and the prevention of seroma formation at the site of injury with an animal.

[0322] A system in accordance with the modalities described herein provides significant benefits, including, but not limited to, one or more of the following: • Enhanced fluid removal from the wound site, providing enhanced healing benefits such as reduced edema by removing excess exudate; • Reduced risk of blockages forming in the system; • Maintaining effective negative pressure on the wound even during air application to ensure effective treatment; • Removal of exudate from a lower portion of a wound where there is a height difference in the wound; • Low power consumption suitable for use in portable wound care systems; • Applying treatment fluids to the wound while maintaining effective negative pressure on the wound to ensure effective treatment; • Providing negative pressure to a larger portion of a treatment space to improve treatment throughout the treatment space; • Ability to configure the system with and without the provision of a treatment fluid supply for the wound; • ease in providing a sterile interface between an air inlet and a wound site. Referências 1. Malmsjo, M., Huddleston, E., & Martin, R. (2014). Biological effects of a disposable, canisterless negative pressure wound therapy system. Eplasty, 14. 2. Ixtaina, V. Y., Nolasco, S. M., & Tomas, M. C. (2008). Petição 870260060944, de 22 / 06 / 2026, pág. 110 / 266 102 / 102 Physical properties of chia (Salvia hispanica L.) seeds. Industrial crops and products, 28(3), 286 a 293. 3. Coorey, R., Tjoe, A., & Jayasena, V. (2014). Gelling properties of chia seed and flour. Journal of food science, 79(5), E859 a E866.

Claims

1. Pump for applying negative pressure to a wound via a wound treatment device (3), the pump characterized in that it comprises: a drive mechanism; at least one flexible chamber (53), the drive mechanism configured to actuate the chamber (53) to compress and expand the chamber (53); a pair of one-way valves (54, 55) in fluid communication with the chamber (53), the pair of one-way valves (54, 55) comprising an inlet valve (54) for fluid flow into the chamber (53), and an outlet valve (55) for fluid flow out of the chamber (53); a pump inlet (56) in fluid communication with at least one inlet valve (55); and a pump outlet (57) in fluid communication with at least one outlet valve (55);wherein compression of chamber (53) causes fluid to flow from chamber (53), through the outlet valve (54) and pump outlet (57), and subsequent expansion of chamber (53) draws fluid from pump inlet (56) through the inlet valve (54) and into chamber (53); and wherein the one-way inlet and outlet valves (54, 55) each have a single orifice only in one fluid flow path through the pump from pump inlet (56) to pump outlet (57) through the inlet valve (54), chamber (53) and outlet valve (55) to allow fluid and tissue debris to pass through the valves (54, 55) when open.

2. Pump, according to claim 1, characterized Petition 870260060944, dated 06 / 22 / 2026, page 112 / 266 2 / 2 by the fact that the single orifice has an area when the valve is open that is equal to or greater than a minimum area of ​​the fluid flow path between the pump inlet (56) and the pump outlet (57).

3. Pump, according to claim 1 or 2, characterized in that the single orifice has an area similar to or greater than an area of ​​the pump inlet (56).

4. Pump, according to any one of claims 1 to 3, characterized in that each inlet and outlet valve (54, 55) comprises a unitary flexible valve member.

5. Pump, according to any one of claims 1 to 4, characterized in that each one-way inlet and outlet valve (54, 55) comprises a duckbill valve.

6. Pump, according to any one of claims 1 to 5, characterized in that the drive mechanism comprises a motor (13) and a swashplate (52), the rotation of the swashplate (52) is driven by the motor (13), to at least one chamber (53) connected to the swashplate (52) to compress and expand with the rotation of the swashplate (52).

7. Pump, according to claim 6, characterized in that each chamber (53) comprises an associated connector (68), the connector (68) being fixed to the chamber (53) and to the oscillating plate (52) so that it moves axially to effect compression and expansion of the respective reservoir (26) with movement of the oscillating plate (52).

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