EP4626500A1

EP4626500A1 - Device and system for negative pressure wound therapy

Info

Publication number: EP4626500A1
Application number: EP23821019.9A
Authority: EP
Inventors: Benjamin A. Pratt; James Seddon; Michele A. Waldner; Jeffrey G. Zinn
Original assignee: Solventum Intellectual Properties Co
Current assignee: Solventum Intellectual Properties Co
Priority date: 2022-12-01
Filing date: 2023-12-01
Publication date: 2025-10-08
Also published as: WO2024116144A1

Abstract

The present disclosure provides a device for a therapy unit configured to apply a negative pressure at a wound site and a canister configured to receive a fluid removed from the wound site in response to the negative pressure applied to the wound site. The device includes a housing adapted to be removably coupled with the therapy unit. The housing includes at least one device airflow channel extending therethrough. The at least one device airflow channel is disposed in fluid communication with the canister when the housing is removably coupled with the therapy unit. The device further includes an airflow unit configured to provide an airflow through the at least one device airflow channel, such that the airflow is directed through the canister.

Description

DEVICE AND SYSTEM FOR NEGATIVE PRESSURE WOUND THERAPY

Cross-Reference to Related Applications

This application claims the benefit of priority to U.S. Provisional Application No. 63/429,183, filed on December 1, 2022, which is incorporated herein by reference in its entirety.

Technical Field

The present disclosure generally relates to a device and a system including the device. In particular, the present disclosure generally relates to a device and a system for negative pressure wound therapy.

Background

Caring for wounds is important in a healing process. Wounds generally produce fluids, e.g., an exudate, such as, slough, necrotic tissue, and microbial load (e.g., bacteria and biofilms). Medical dressings are generally used at a wound site to address the production and removal of the fluids from the wound. If not properly addressed, the fluids at the wound can lead to infection or maceration of the wound site.

Negative pressure wound therapy (NPWT) systems are embodied as sealed wound-care systems particularly indicated for wounds, such as, chronic persistent wounds and/or complicated wounds. Specifically, for promoting wound healing, a pressure that is reduced relative to the surroundings (commonly referred to as “negative pressure”) is applied to the wound. The negative pressure causes mechanical contraction of the wound and removal of the exudates from the wound, thus promoting formation of granulation tissues and accelerating wound healing. The NPWT system typically includes a therapy unit that is in fluid communication with the wound.

The exudates are generally collected in a canister for disposal or analysis. Typically, the canisters are sized to obviate the need for frequent replacement even when used in the treatment of patients with wounds generating a high volume of exudate.

Summary

Generally, the present disclosure relates to a device and a system including the device for negative pressure wound therapy.

In a first aspect, the present disclosure provides a device for a therapy unit configured to apply a negative pressure at a wound site and a canister configured to receive a fluid removed from the wound site in response to the negative pressure applied to the wound site. The device includes a housing adapted to be removably coupled with the therapy unit. The housing includes at least one device airflow channel extending therethrough. The at least one device airflow channel is disposed in fluid communication with the canister when the housing is removably coupled with the therapy unit. The device further includes an airflow unit configured to provide an airflow through the at least one device airflow channel, such that the airflow is directed through the canister.

In a second aspect, the present disclosure provides a system. The system includes a therapy unit including a negative pressure source fluidly communicating with a wound site and configured to apply a negative pressure at the wound site. The system further includes a canister fluidly communicating with the wound site and configured to receive a fluid removed from the wound site in response to the negative pressure applied to the wound site. The canister is configured to be removably coupled with the therapy unit. The canister includes at least one canister airflow channel extending therethrough. The system further includes a device for the therapy unit. The device includes a housing adapted to be removably coupled with the therapy unit. The housing includes at least one device airflow channel extending therethrough. The device further includes an airflow unit configured to provide an airflow through the at least one device airflow channel. When the housing is removably coupled with the therapy unit, the at least one device airflow channel is in fluid communication with the at least one canister airflow channel of the canister, such that the airflow is directed through the at least one canister airflow channel.

The details of one or more examples of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the disclosure will be apparent from the description and drawings, and from the claims.

Brief Description of the Drawings

Exemplary embodiments disclosed herein may be more completely understood in consideration of the following detailed description in connection with the following figures. The figures are not necessarily drawn to scale. Like numbers used in the figures refer to like components. However, it will be understood that the use of a number to refer to a component in a given figure is not intended to limit the component in another figure labeled with the same number.

FIG. 1 A is a schematic front view illustrating a system including a therapy unit, a canister, and a device detached from the therapy unit, according to an embodiment of the present disclosure;

FIG. IB is a schematic top view illustrating the system, according to an embodiment of the present disclosure;

FIG. 2A is a schematic front view illustrating the therapy unit and the canister removably coupled to the device, according to an embodiment of the present disclosure;

FIG. 2B is a schematic top view of the system of FIG. 2A, according to an embodiment of the present disclosure;

FIGS. 3A and 3B are schematic bottom views of the device in non-operational and operational modes, respectively, according to an embodiment of the present disclosure;

FIG. 3C is a schematic front view of the device, according to an embodiment of the present disclosure; FIG. 3D is a schematic front view of the device, according to another embodiment of the present disclosure;

FIG. 4A is a schematic view of a canister, according to an embodiment of the present disclosure;

FIG. 4B is a schematic exploded view of the canister, according to an embodiment of the present disclosure;

FIG. 5 is a schematic front view of the system, according to another embodiment of the present disclosure;

FIG. 6 is a bar graph depicting an effect of environmental conditions on a rate of evaporation of a fluid in the system, according to an embodiment of the present disclosure; and

FIG. 7 is a bar graph depicting a performance of the system and a performance of a passive evaporation system, according to an embodiment of the present disclosure.

Detailed Description

In the following description, reference is made to the accompanying figures that form a part thereof and in which various embodiments are shown by way of illustration. It is to be understood that other embodiments are contemplated and may be made without departing from the scope or spirit of the present disclosure. The following detailed description, therefore, is not to be taken in a limiting sense.

In the following disclosure, the following definitions are adopted.

As used herein, all numbers should be considered modified by the term “about”. As used herein, “a,” “an,” “the,” “at least one,” and “one or more” are used interchangeably.

The term “about”, unless otherwise specifically defined, means to a high degree of approximation (e.g., within +/- 5% for quantifiable properties) but again without requiring absolute precision or a perfect match.

As used herein as a modifier to a property or attribute, the term “generally”, unless otherwise specifically defined, means that the property or attribute would be readily recognizable by a person of ordinary skill but without requiring absolute precision or a perfect match (e.g., within +/- 20 % for quantifiable properties).

The term “substantially”, unless otherwise specifically defined, means to a high degree of approximation (e.g., within +/- 10% for quantifiable properties) but again without requiring absolute precision or a perfect match.

Terms such as same, equal, uniform, constant, strictly, and the like, are understood to be within the usual tolerances or measuring error applicable to the particular circumstance rather than requiring absolute precision or a perfect match.

As used herein, the terms “first” and “second” are used as identifiers. Therefore, such terms should not be construed as limiting of this disclosure. The terms “first” and “second” when used in conjunction with a feature or an element can be interchanged throughout the embodiments of this disclosure. As used herein, “at least one of A and B” should be understood to mean “only A, only B, or both A and B”.

The term “coupled”, or “connected” may include direct physical connections between two or more components, or indirect physical connections between two or more components that are connected together by one or more additional components. For example, a first component may be coupled to a second component by being directly connected together or by being connected by a third component.

As used herein, the term “configured to” and like is at least as restrictive as the term “adapted to” and requires actual design intention to perform the specified function rather than mere physical capability of performing such a function.

As used herein, the term “communicably coupled to” refers to direct coupling between components and/or indirect coupling between components via one or more intervening components. Such components and intervening components may comprise, but are not limited to, junctions, communication paths, components, circuit elements, circuits, functional blocks, and/or devices. As an example of indirect coupling, a signal conveyed from a first component to a second component may be modified by one or more intervening components by modifying the form, nature, or format of information in a signal, while one or more elements of the information in the signal are nevertheless conveyed in a manner than can be recognized by the second component.

As used herein, the term “signal,” includes, but is not limited to, one or more electrical signals, optical signals, electromagnetic signals, analog and/or digital signals, one or more computer instructions, a bit and/or bit stream, or the like.

As used herein, the term “airflow rate” may refer to a volume or mass of air passing through a device in a given time.

As used herein, the terms “layer,” “sheet,” and “dressing,” or variations thereof, are used to describe an article having a thickness that is small relative to its length and width.

As used herein, the term “negative pressure” broadly refers to a pressure lower than a local pressure in a local environment outside of a sealed treatment environment provided by a dressing. In many cases, the local ambient pressure can also be the atmospheric pressure at which a wound site is located. Alternatively, the pressure can be less than a hydrostatic pressure associated with a tissue at the wound site. Unless otherwise specified, the pressure values described herein are gauge pressures. Similarly, a reference to an increase in negative pressure typically refers to a decrease in absolute pressure, while a decrease in negative pressure typically refers to an increase in absolute pressure.

As used herein, the term “wounds” may include, for example, chronic, acute, traumatic, subacute, closed surgical wounds or dehiscence wounds, partially thick bums, ulcers (such as, diabetic, compressive, or venous insufficiency ulcers), flaps, and grafts. The wound may also include an open abdomen area of a patient.

As used herein, the term “wound site” may include a tissue site, such as, bone tissue, adipose tissue, muscle tissue, nerve tissue, skin tissue, vascular tissue, connective tissue, cartilage, tendons, or ligaments. The term “wound site” may also refer to an area of a tissue that is not necessarily a wound or a defect but may be desired to add or promote additional tissue growth. For example, negative pressure therapy can be used in a particular tissue area to grow additional tissue that can be harvested or transplanted to another tissue site. The wound site may also include an area wherein a surgical incision has been previously performed.

NPWT systems are often used to promote wound healing. In order to heal a wound, a preset volume of instillation fluid is delivered at a wound site along with an application of a negative pressure. Since the NPWT system fluidly communicates with the wound site, the NPWT system removes a fluid, e.g., an exudate from the wound site by applying the negative pressure on a medical dressing attached to the wound site and collects the fluid in a canister for disposal or analysis. For example, the exudate may include slough, necrotic tissue, and microbial load (e.g., bacteria and biofilms). The canister of the NPWT system can only store a specific volume of fluid which when filled must be removed and an empty canister must be installed.

Management of the exudate and the instillation fluids during the application of the negative pressure may impact a size of the NPWT system. Specifically, management of the exudate and the instillation fluids during the application of the negative pressure may impact a size of the canisters which may, in turn, impact a portability of the NPWT system. The canisters are typically sized to obviate the need for frequent replacement even when used in the treatment of patients with wounds generating a high volume of exudate. However, an increase in the size of the canisters may negatively impact the portability of the NPWT system. The increase in the size of the canisters may further increase a weight of the NPWT system, further reducing the portability of the NPWT system. On the other hand, a decrease in the size of the canisters may enhance the portability of the NPWT system.

Therefore, there exists a need for a NPWT system that may manage greater volumes of the fluids without increasing the size of the canister which may otherwise negatively impact the portability of the NPWT system.

The present disclosure relates to a device and a system for negative pressure wound therapy (NPWT) including the device.

The system includes a therapy unit including a negative pressure source fluidly communicating with a wound site and configured to apply a negative pressure at the wound site. The system further includes a canister fluidly communicating with the wound site and configured to receive a fluid removed from the wound site in response to the negative pressure applied to the wound site. The canister is configured to be removably coupled with the therapy unit. The canister includes at least one canister airflow channel extending therethrough. The system further includes a device for the therapy unit. The device includes a housing adapted to be removably coupled with the therapy unit. The housing includes at least one device airflow channel extending therethrough. The device further includes an airflow unit configured to provide an airflow through the at least one device airflow channel. When the housing is removably coupled with the therapy unit, the at least one device airflow channel is in fluid communication with the at least one canister airflow channel of the canister, such that the airflow is directed through the at least one canister airflow channel.

The airflow unit configured to provide the airflow may therefore actively enhance evaporation of the fluid removed from the wound site and stored in the canister. Due to the evaporation of the fluid from the canister, a volume of the fluid in the canister may be kept below a maximum capacity of the canister for a significantly longer time duration. In other words, a greater volume of the fluid can be received and stored by the same canister without a requirement to replace the canister for the significantly longer time duration. Therefore, an effective evaporation of the fluid from the canister may increase the time over which the system can be used without a need to empty or replace the canister. In some examples, the airflow unit may further be configured to provide the evaporation to prevent the fluid in the canister from attaining the maximum capacity during a typical duration for treatment of the wound site. The airflow unit may therefore provide enhanced evaporation of the fluid from the canister to extend per usage time of the canister. In some cases, the size of the canister may be reduced to further increase the portability of the system. Thus, a smaller canister may manage the greater volume of the fluid. This may also lead to a reduction in a size of the therapy unit, and thereby, a size and a weight of the overall system.

The evaporation of the fluid stored in the canister by the airflow may maintain the volume of the fluid inside the canister below the maximum capacity of the canister, such that a larger volume of the fluid may be removed from the wound site without increasing the size of the canister or reducing the portability of the system. In other words, due to the effective evaporation via the airflow unit of the device, an ability of the system to manage an increase in the volume of the fluid removed from the wound site may be substantially independent of the size of the canister and thus may improve the portability of the system.

FIG. 1A is a schematic front view illustrating a system 100, according to an embodiment of the present disclosure. The system 100 includes a therapy unit 102. The therapy unit 102 includes a negative pressure source 104 fluidly communicating with a wound site 106 and configured to apply a negative pressure at the wound site 106. In some examples, the negative pressure source 104 may include a peristaltic pump, a diaphragmatic pump, or any other suitable mechanism. In some other examples, the negative pressure source 104 may be a miniature pump or micropump that may be adapted to maintain or draw adequate and therapeutic negative pressure levels. Particularly, the system 100 is embodied as a negative pressure wound therapy (NPWT) system herein. Alternatively, the system 100 may be embodied as a wound therapy system for treating wounds, conventionally known in the art.

The system 100 further includes a canister 108 fluidly communicating with the wound site 106 and configured to receive a fluid 110 removed from the wound site 106 in response to the negative pressure applied to the wound site 106. The canister 108 may be configured to receive the fluid 110 removed from the wound site 106 in response to the negative pressure applied to the wound site 106 by the negative pressure source 104. Therefore, the canister 108 is configured to store the fluid 110, such as exudates, which may tend to harbor bacteria in the wound site 106.

Further, the canister 108 is configured to be removably coupled with the therapy unit 102. In the illustrated embodiment of FIG. 1A, the canister 108 is shown removably coupled with the therapy unit 102. In some examples, the therapy unit 102 may include a keyway recess (not shown) that may receive a latch (not shown) of the canister 108 to removably couple the canister 108 with the therapy unit 102. In some other examples, the therapy unit 102 and the canister 108 may include any other attachment mechanism to removably couple the canister 108 with the therapy unit 102. The canister further includes at least one canister airflow channel 112 extending therethrough.

In some examples, the canister 108 may be formed of any type of material that is suitable for containing the fluid 110. In some examples, the canister 108 may be in a form of a semi-rigid plastic bottle, a flexible polymeric pouch, or other hollow container. In some examples, at least a portion of the canister 108 may be transparent or semi-transparent, e.g., to permit a visual assessment of the fluid 110 received from the wound site 106.

The system 100 further includes a device 114 for the therapy unit 102. The device 114 includes a housing 116 adapted to be removably coupled with the therapy unit 102. In the illustrated embodiment of FIG. 1A, the housing 116 of the device 114 is shown detached from the therapy unit 102. The housing 116 includes at least one device airflow channel 118 extending therethrough. In some examples, the device 114 may determine if the canister 108 is removably coupled to the therapy unit 102 via an optical QR code, an optical Barcode, an optical unique element, a non-contact near field communication (NFC), a non-contact RFID tag, or manual user settings.

FIG. IB is a schematic top view illustrating the system 100, according to an embodiment of the present disclosure. In the illustrated embodiment of FIG. IB, the housing 116 of the device 114 is shown detached from the therapy unit 102 of the system 100. Further, the housing 116 is illustrated as having a rectangular cross-section with rounded ends. In some other embodiments, the housing 116 may have a rectangular, a square, a circular, or a polygonal cross-sectional configuration.

FIG. 2A is a schematic front view illustrating the system 100, according to an embodiment of the present disclosure. In the illustrated embodiment of FIG. 2A, the housing 116 of the device 114 is shown removably coupled to the therapy unit 102 of the system 100. In some examples, the housing 116 of the device 114 may be removably coupled to the therapy unit 102 of the system 100 by any suitable attachment mechanism, such as mechanical or magnetic means. As shown schematically in FIG. 2A, the at least one device airflow channel 118 of the housing 116 is disposed in fluid communication with the canister 108. Particularly, the at least one device airflow channel 118 is disposed in fluid communication with the canister 108 when the when the housing 116 is removably coupled with the therapy unit 102. Further, the at least one device airflow channel 118 aligns with the at least one canister airflow channel 112 when the therapy unit 102 is removably coupled to the device 114. In the illustrated embodiment of FIG. 2A, dimensions of at least one device airflow channel 118 are illustrated similar to corresponding dimensions of at least one canister airflow channel 112, such that when the housing 116 is removably coupled with the therapy unit 102, the at least one device airflow channel 118 may fully align with the at least one canister airflow channel 112. In some other embodiments, the dimensions of the at least one device airflow channel 118 may be different from the corresponding dimensions of the at least one canister airflow channel 112. However, the at least one device airflow channel 118 may at least partially align with the at least one canister airflow channel 112 of the canister 108.

FIG. 2B is a schematic top view illustrating the housing 116 removably coupled to the therapy unit 102, according to an embodiment of the present disclosure.

With reference to FIGS. 1A to 2B, the device 114 includes an airflow unit 126. In the illustrated embodiment, the airflow unit 126 is disposed within the housing 116 of the device 114. However, in some other embodiments, the airflow unit 126 may be disposed external to the housing 116 of the device 114. The airflow unit 126 is configured to provide an airflow 120 through the at least one device airflow channel 118. Specifically, the airflow unit 126 is configured to provide the airflow 120 through the at least one device airflow channel 118, such that the airflow 120 is directed through the canister 108. More specifically, when the housing 116 is removably coupled with the therapy unit 102, the at least one device airflow channel 118 is in fluid communication with the at least one canister airflow channel 112 of the canister 108, such that the airflow 120 is directed through the at least one canister airflow channel 112. Disposing the airflow unit 126 in a device, i.e., the device 114 separate from the therapy unit 102, may ensure that the therapy unit 102 is smaller and in size lighter in weight. Further, the device 114 separate from the therapy unit 102 may include a separate power source and power supply. Therefore, power requirements of the airflow unit 126 may not negatively impact power requirements of the therapy unit 102.

As shown in FIGS. 1A and 2A, the at least one device airflow channel 118 may extend between an inlet 122 and an outlet 124 (shown in FIG. 1A). The outlet 124 may direct the airflow 120 to the at least one canister airflow channel 112.

In some embodiments, the device 114 further includes a controller 128 communicably coupled to the airflow unit 126. The controller 128 may include one or more processors and one or more memories. It should be noted that the one or more processors may embody a single microprocessor or multiple microprocessors for receiving various input signals. Numerous commercially available microprocessors may be configured to perform the functions of the one or more processors. Each processor may further include a general processor, a central processing unit, an application specific integrated circuit (ASIC), a digital signal processor, a field programmable gate array (FPGA), a digital circuit, an analog circuit, a controller, a microcontroller, any other type of processor, or any combination thereof. Each processor may include one or more components that may be operable to execute computer executable instructions or computer code that may be stored and retrieved from the one or more memories. In some embodiments, the controller 128 is configured to control the airflow unit 126 based on an airflow rate of the airflow 120 through the at least one device airflow channel 118. In some examples, the airflow rate may be based on manual user settings.

Further, in some embodiments, the device 114 includes a detection sensor 130 configured to generate a detection signal 131 when the device 114 is removably coupled with the therapy unit 102. The detection sensor 130 is communicably coupled to the controller 128. In some embodiments, the controller 128 is configured to control the airflow unit 126 upon receiving the detection signal 131.

In some embodiments, at least one of the device 114 and the canister 108 includes at least one sensor 132 configured to generate at least one signal 134. In some embodiments, the at least one sensor 132 includes at least one of a temperature sensor, a pressure sensor, a humidity sensor, a fluid level sensor, and a weight sensor. Particularly, the temperature sensor may be configured to generate a temperature signal based on a temperature of the ambient air. The pressure sensor may be configured to generate a pressure signal based on atmospheric pressure. The humidity sensor may be configured to generate a humidity signal based on the humidity present in the ambient air. The fluid level sensor may be configured to generate a fluid level signal based on a level of the fluid 110 in the canister 108 removed from the wound site 106. The weight sensor may be configured to generate a weight signal based on a weight of the fluid 110 in the canister 108 removed from the wound site 106. In some embodiments, the at least one sensor may include a combination of the temperature sensor, the pressure sensor, the humidity sensor, the fluid level sensor, and the weight sensor.

The at least one sensor 132 is communicably coupled to the controller 128. Specifically, at least one of the temperature sensor, the pressure sensor, the humidity sensor, the fluid level sensor, and the weight sensor may be communicably coupled to the controller 128. In some embodiments, the controller 128 is configured to determine the airflow rate based on the at least one signal 134. In some embodiments, the controller 128 may control the airflow unit 126 based on the at least one signal 134 generated by the at least one sensor 132. Specifically, the controller 128 may control the airflow unit 126 based on the at least one signal 134, such that the airflow unit 126 provides the airflow rate. Since the fluid level signal generated by the fluid level sensor and/or the weight signal generated by the weight sensor may be indicative of a volume VI of fluid in the canister 108, the controller 128 may be configured to control the airflow unit 126 based on the volume VI of the fluid 110 in the canister 108.

In some embodiments, the system 100 further includes an alarm unit 136 communicably coupled to the controller 128. In some embodiments, the device 114 includes the alarm unit 136. In some embodiments, the canister 108 includes the alarm unit 136. The alarm unit 136 is configured to generate an alarm 138 when the volume V 1 of the fluid 110 in the canister 108 crosses a predetermined volume threshold. In some examples, the alarm unit 136 may be powered by a battery (not shown) associated with the system 100. In some examples, the alarm 138 may include at least one of a visual alert, an audio alert, a haptic alert, and a text message. In some other examples, the alarm 138 may include an email notification. In some examples, the alarm unit 136 may include at least one of a speaker, a vibration device, a light emitting diode, a buzzer, and a message generator. In some examples, the alarm 138 generated by the alarm unit 136 may be used to notify an operator (for example, a nurse or a doctor) to provide quick assistance. In some alternative examples, the alarm unit 136 may include a switch configured to be actuated by a patient based on the visual assessment through at least the portion of the canister 108 that may be transparent or semi-transparent. The operator or the patient may activate the airflow unit 126, modify settings of the airflow unit 126, or replace the canister 108 with an empty canister upon receiving the alarm 138.

The airflow unit 126 configured to provide the airflow 120 may actively enhance evaporation ofthe fluid 110 removed from the wound site 106 and stored in the canister 108. Due to this evaporation of the fluid 110 from the canister 108, the volume VI of the fluid 110 in the canister 108 may be kept below a maximum capacity of the canister 108 for a significantly longer time. In other words, a greater volume of the fluid 110 can be received and stored by the canister 108 without a requirement to replace the canister for the significantly longer time duration. Therefore, an effective evaporation of the fluid 110 from the canister 108 may increase the time over which the system 100 can be used without a need to empty or replace the canister 108. In some examples, the airflow unit 126 may further be configured to provide the evaporation to prevent the fluid 110 in the canister 108 from attaining the maximum capacity during a typical duration for treatment of the wound site 106. The airflow unit 126 may therefore provide enhanced evaporation of the fluid 110 from the canister 108 to extend per usage time of the canister 108. In some cases, a size of the canister 108 may be reduced to further increase portability of the system 100. Thus, a smaller canister may manage the greater volume of the fluid 110. This may also lead to reduction in a size of the therapy unit 102, and thereby, a size and a weight of the system 100.

The evaporation of the fluid 110 stored in the canister 108 by the airflow 120 may maintain the volume VI of the fluid 110 inside the canister 108 below the maximum capacity of the canister 108, such that a larger amount of fluid 110 may be removed from the wound site 106 without increasing the size of the canister 108 or reducing the portability of the system 100. In other words, due to the effective evaporation via the airflow unit 126 of the device 114, an ability of the system 100 to manage an increase in the volume VI of the fluid 110 removed from the wound site 106 may be substantially independent of the size of the canister 108 and thus may improve the portability of the system 100.

FIGS. 3A and 3B illustrate schematic bottom views of the device 114, according to an embodiment of the present disclosure. Specifically, FIG. 3 A illustrates the schematic bottom view of the device 114 when the airflow unit 126 is in a non-operational mode. FIG. 3B illustrates the schematic bottom view of the device 114 when the airflow unit 126 is in an operational mode. FIG. 3C illustrates a schematic front view of the device 114 when the airflow unit 126 is in the operational mode.

The airflow unit 126 ofthe device 114 of FIGS. 3A and 3B includes a plurality of modules 140. As illustrated in the embodiments of FIGS. 3A and 3B, the plurality of modules 140 is disposed linearly along a length of the housing 116 of the device 114. In some embodiments, one or more modules 140 of the plurality of modules 140 are removably disposed in the at least one device airflow channel 118. Further, in some embodiments, the airflow unit 126 includes at least one of a blower 142, a heater 144, and a dehumidifier 146. Particularly, each of the plurality of modules 140 may include the blower 142, the heater 144, and/or the dehumidifier 146. The airflow unit 126 of the device 114 of FIGS. 3A to 3C includes the blower 142, the heater 144, and the dehumidifier 146 as separate modules 140. Specifically, three modules 140 include the blower 142, the heater 144, and the humidifier 146. The blower 142, the heater 144, and/or the dehumidifier 146 may be disposed linearly along the length of the housing 116 in any order, as per desired application attributes.

In some examples, the dehumidifier 146 may reduce and maintain a desired level of humidity in the airflow 120 (shown in FIG. 3B) flowing through the at least one device airflow channel 118. The dehumidifier 146 may further extract water from the airflow 120, such that the at least one canister airflow channel 112 may receive a dehumidified airflow 120. The dehumidified airflow 120 provided by the dehumidifier 146 may enhance evaporation of the fluid 110 inside the canister 108. The dehumidifier 146 may further extract water from the airflow 120 that may otherwise produce odor and/or growth of fungus in the fluid 110 in the canister 108. The dehumidifier 146 may be powered by the battery of the system 100.

In some examples, the heater 144 may heat the airflow 120 (shown in FIG. 3B) directed through the canister 108 via the at least one device airflow channel 118 to a desired temperature. Specifically, when the housing 116 is removably coupled with the therapy unit 102, the heater 144 may heat the airflow 120 flowing through the at least one device airflow channel 118, such that the at least one canister airflow channel 112 may receive the heated airflow 120. The heated airflow 120 provided by the heater 144 may enhance evaporation of the fluid 110 inside the canister 108. The heater 144 may be powered by the battery of the system 100. In some embodiments, the heater 144 may be an infrared heater or an electric heater. In some other embodiments, the heater 144 may include any other heating means, such as a heating mat to heat the airflow 120.

In some examples, the blower 142 may be configured to pull air from the inlet 122 and push the ambient air towards the at least one canister airflow channel 112 through the outlet 124 to provide a faster airflow 120. The faster airflow 120 provided by the blower 142 may enhance evaporation of the fluid 110 inside the canister 108. In some other examples, the blower 142 may be an axial fan (not shown) driven by an electric motor (not shown). The electric motor may be powered by the battery of the system 100.

FIG. 3D illustrates a schematic front view of the device 114, according to another embodiment of the present disclosure. In the illustrated embodiment of FIG. 3D, the airflow unit 126 of the device 114 includes the plurality of modules 140 disposed in a vertical stack i.e., in a staggered arrangement along a height of the housing 116 instead of being disposed linearly along the length of the housing 116 of the device 114 (as shown in FIGS. 3A and 3B). The blower 142, the heater 144, and/or the dehumidifier 146 may be disposed in the vertical staggered arrangement in any order, as per desired application attributes.

Referring to FIGS. 3A-3D, in some embodiments, the controller 128 may control the functioning of any one of the blower 142, the heater 144, and/or the dehumidifier 146 based on the at least one signal 134 generated by the at least one sensor 132 (e.g., the temperature sensor, the pressure sensor, and the humidity sensor) to facilitate evaporation of the fluid 110 in the canister 108. In some other examples, the controller 128 may control the functioning of any one of the blower 142, the heater 144, and/or the dehumidifier 146 based on the detection signal 131 generated by the detection sensor 130. In some other examples, the alarm unit 136 may further generate the alarm 138 in case of malfunctioning of any one of the blower 142, the heater 144, and/or the dehumidifier 146. In some examples, the controller 128 may create variations in the airflow rate of the airflow 120 which may further enhance evaporation of the fluid 110.

FIG. 4A illustrates a schematic view of the canister 108, according to an embodiment of the present disclosure. FIG. 4B illustrates a schematic exploded view of the canister 108, according to an embodiment of the present disclosure.

With reference to FIGS. 4A and 4B, the canister 108 includes a canister body 148 configured to store the fluid 110 (shown in FIG. 1) removed from the wound site 106 (shown in FIG. 1). In some examples, the canister body 148 may be made of a glass, a metallic material, a polymeric material, a ceramic material, or combination thereof. In some other examples, the canister body 148 may be made of a material that is water resistant and corrosion resistant.

The canister 108 further includes a canister lid 150 removably coupled to the canister body 148. The canister lid 150 may prevent a spillage of the fluid 110 stored in the canister 108. In some examples, the canister lid 150 may be made of a material similar to the material of the canister body 148. In some other examples, the canister lid 150 may prevent foreign particles (such as dust and dirt particles) from contacting the fluid 110 stored in the canister 108. Such foreign particles can otherwise contaminate the fluid 110 stored in the canister 108 and increase bacterial growth and odor in the canister body 148. The canister lid 150 may be removed from the canister body 148 to empty the canister 108.

The canister 108 further includes a membrane carrier 152. In the illustrated embodiment of FIG. 4A, the canister 108 includes a pair of membrane carriers 152 disposed opposite to each other in the canister body 148. The membrane carrier 152 includes a plurality of through-holes 154 disposed in fluid communication with the canister body 148. The membrane carrier 152 includes the at least one canister airflow channel 112 disposed in fluid communication with the plurality of through-holes 154.

The canister 108 further includes at least one membrane 156 disposed at least on the plurality of through-holes 154 of the membrane carrier 152. In some embodiments, the at least one membrane 156 is vapor permeable and liquid impermeable. In some examples, the at least one membrane 156 may include a membrane having a high moisture vapor transmission rate (MVTR). In some examples, the at least one membrane 156 may include foams, such as polyurethane foam, Libeltex TDL2, Libeltex TL4, Baltex 3DXD spacer fabrics, Baltex 4DXD spacer fabrics, or the like.

In the illustrated embodiment of FIG. 4A, the canister 108 includes a pair of membranes 156 corresponding to the pair of membrane carriers 152. Specifically, each membrane carrier 152 from the pair of membrane carriers 152 is configured to receive the membrane 156 from the pair of membranes 156. The membrane carrier 152 allows the airflow 120 to contact with the fluid 110 removed from the wound site 106 and stored in the canister 108 through the plurality of through-holes 154, such that the airflow 120 may evaporate the fluid 110 stored in the canister 108. Further, the at least one membrane 156 may not allow a flow of the fluid 110 inside the at least one canister airflow channel 112. In some examples, a rate of evaporation of fluid 110 may depend on a number of through-holes 154 of the membrane carrier 152. In other words, an increase in the number of through-holes 154 may increase the rate of evaporation of the fluid 110 stored in the canister 108. The number of through-holes 154 may be based on desired application attributes.

In some alternative embodiments, the canister 108 may include a rigid porous membrane. In such cases, the membrane carrier 152 may not be required. In some examples, the plurality of modules 140 (shown in FIG. 3 A) of the airflow unit 126 (shown in FIG. 1) may enhance the rate of evaporation through the plurality of through-holes 154 of the membrane carrier 152.

FIG. 5 illustrates a schematic front view of the system 100, according to another embodiment of the present disclosure. In the illustrated embodiment of FIG. 5, the system 100 further includes a secondary canister 508. The secondary canister 508 includes at least one secondary canister airflow channel 512 extending therethrough. In some examples, the secondary canister 508 may be substantially similar and functionally equivalent to the canister 108.

The housing 116 of the device 114 is further adapted to be removably coupled with the secondary canister 508. In some examples, the housing 116 may include a keyway recess (not shown) that may receive a latch (not shown) of the secondary canister 508 to removably couple the secondary canister 508 with the housing 116. In some other embodiments, the secondary canister 508 may be removably coupled to the therapy unit 102.

In the illustrated embodiment of FIG. 5, the housing 116 further includes at least one additional device airflow channel 518 disposed in fluid communication with the at least one device airflow channel 118. Further, the at least one additional device airflow channel 518 is in fluid communication with the at least one secondary canister airflow channel 512, such that at least a portion of the airflow 120 is directed through the at least one secondary canister airflow channel 512. Particularly, the at least one additional device airflow channel 518 may substantially align with the at least one secondary canister airflow channel 512. In the illustrated embodiment of FIG. 5, dimensions of the at least one additional device airflow channel 518 are shown as similar to corresponding dimensions of the at least one secondary canister airflow channel 512, such that when the secondary canister 508 is removably coupled with the housing 116, the at least one additional device airflow channel 518 may fully align with the at least one secondary canister airflow channel 512. In some other embodiments, the dimensions of the at least one additional device airflow channel 518 may be different from the corresponding dimensions of the at least one secondary canister airflow channel 512. However, the at least one additional device airflow channel 518 may at least partially align with the at least one secondary canister airflow channel 512 of the secondary canister 508.

The airflow unit 126 may therefore be configured to provide the airflow 120 which may enhance evaporation of the fluid 110 from the canister 108 and the secondary canister 508 simultaneously.

TESTS

Test 1

A test was conducted to determine an effect of different environmental conditions (such as an ambient temperature and a relative humidity (RH) of ambient air) on a rate of evaporation of a fluid (e.g., the fluid 110) in the system 100. In this test, the environmental conditions, for example, the ambient temperature and the relative humidity were varied to determine an average moisture vapor transmission rate (MVTR) of the system 100 based on a worst case environmental condition, an expected environmental condition, and a best case environmental condition for an effective evaporation in the system 100. Further, in this test, the negative pressure was maintained at around -125 millimeters of mercury (mmHg) and the fluid used was ionized water.

During the test, the system 100 was operated at the worst case environmental conditions, the expected environmental conditions, and the best case environmental conditions and the average MVTR was measured. During the best case environmental conditions, the ambient temperature was maintained at 38 degrees Celsius (°C)/100 degrees Fahrenheit (°F) and the relative humidity was maintained at 10%. Further, during the worst case environmental conditions, the ambient temperature was maintained at 18°C/64°F and the relative humidity was maintained at 90%. Furthermore, during the expected environmental conditions, the ambient temperature was maintained at 18°C/64°F and the relative humidity was maintained at 60%.

The average MVTR was measured in gram per square meter per 24 hours (g/m²/24h). The measured values of the average MVTR are summarized in Table 1 provided below.

Table 1 The data of Table 1 demonstrates that when the system 100 was operated at the best case environmental conditions i.e., at a low humidity and a high temperature (i.e., 38°C and 10% RH), the average MVTR recorded was 14828 g/m²/24hrs. Further, when the system 100 was operated at the worst case environmental conditions i.e., at a high humidity and an average indoor room temperature (i.e., 18°C and 90% RH), the average MVTR recorded was 2210 g/m²/24hrs. The data demonstrates that the average MVTR improved when the system 100 was operated at the best case environmental conditions compared to when the system 100 was operated at the worst case environmental conditions. Specifically, the average MVTR was almost 7 times more effective when the system 100 was operated at the best case environmental conditions than when the system 100 was operated at the worst case environmental conditions. Moreover, when the system 100 was operated at the expected environmental condition (i.e., 18°C and 60% RH), the average MVTR recorded was 7212 g/m²/24hrs. Therefore, the high humidity of the worst case environmental conditions negatively impacted the average MVTR. Since, the average MVTR was highest for the best case environmental conditions having the low humidity and the high temperature, the low humidity and the high temperature enhanced the evaporation rate of the system 100.

FIG. 6 shows an exemplary bar graph 600 depicting the effect of the different environmental conditions on the rate of evaporation of the system 100 discussed above. Particularly, the bar graph 600 depicts the results of the Test 1 conducted to determine the effect of environmental conditions on the rate of evaporation in the system 100. The bar graph 600 depicts the average MVTR on the ordinate (Y -axis), and the reference numbers 602, 604, 606 representing the best case environmental condition, the worst case environmental condition, and the expected environmental condition, respectively, on the abscissa (X-axis).

The bar graph 600 includes a first bar 608 depicting the average MVTR of the best case environmental condition. As is apparent from the bar graph 600, the first bar 608 has the average MVTR equal to about 14828 g/m²/24hrs. The bar graph 600 further includes a second bar 610 depicting the average MVTR of the worst case environmental condition. As is apparent from the bar graph 600, the second bar 610 has the average MVTR equal to about 2210 g/m²/24hrs. The bar graph 600 further includes a third bar 612 depicting the average MVTR of the expected environmental condition. As is apparent from the bar graph 600, the third bar 612 has the average MVTR equal to about 7212 g/m²/24hrs.

Test 2

A test was conducted to compare a performance of the system 100 (shown in FIG. 1) and a performance of a passive evaporation system in the best case environmental conditions and the worst case environmental conditions.

The measured values of the average MVTR for the system 100 and the passive evaporation system during the best environmental conditions and the worst case environmental conditions are summarized in Table 2 provided below. Table 2

At the best case environmental condition, i.e., 38°C and 10% RH, the average MVTR recorded was equal to about 14828 g/m²/24hrs for the system 100 and was equal to about 5108 g/m²/24hrs for the passive evaporation system. Further, at the worst case environmental conditions i.e., 18°C and 90% RH, the average MVTR recorded was equal to about 2210 g/m²/24hrs for the system 100 and was equal to about 251 g/m²/24hrs for the passive evaporation system.

The data of Table 2 demonstrates that the system 100 provides a greater average MVTR and therefore a higher rate of evaporation at both the best case environmental conditions and the worst case environmental conditions than the passive evaporation system. Further, in the worst case environmental conditions, the system 100 is 9 times more effective than the passive evaporation system.

FIG. 7 shows an exemplary bar graph 700 depicting a performance of the system 100 (shown in FIG. 1) and a performance of the passive evaporation system. Particularly, the bar graph 700 depicts the results of the Test 2 conducted to compare the performance of forced air evaporation system and passive evaporation system in the best case environmental conditions and worst case environmental conditions. The bar graph 700 depicts the average MVTR on the ordinate (Y -axis), and the reference numbers 702, 704, 706, 708 representing the system 100 at the best case environmental condition, the passive evaporation system at the best case environmental condition, the system 100 at the worst case environmental condition, and the passive evaporation system at the worst case environmental condition, respectively, on the abscissa (X-axis).

The bar graph 700 includes a first bar 710 depicts the forced air evaporation system (i.e., the system 100) at the best case environmental condition. As is apparent from the bar graph 700, the first bar 710 has the average MVTR equal to about 14828 g/m²/24hrs. The bar graph 700 further includes a second bar 712 depicting the passive evaporation system at the best case environmental condition. As is apparent from the bar graph 700, the second bar 712 has the average MVTR equal to about 5108 g/m²/24hrs. The bar graph 700 further includes a third bar 714 depicts the forced air evaporation system (i.e., the system 100) at the worst case environmental condition. As is apparent from the bar graph 700, the third bar 710 has the average MVTR equal to about 2210 g/m²/24hrs. The bar graph 700 further includes a fourth bar 716 depicting the passive evaporation system at the worst case environmental condition. As is apparent from the bar graph 700, the fourth bar 716 has the average MVTR equal to about 251 g/m²/24hrs.

Unless otherwise indicated, all numbers expressing feature sizes, amounts, and physical properties used in the specification and claims are to be understood as being modified by the term “about”. Accordingly, unless indicated to the contrary, the numerical parameters set forth in the foregoing specification and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by those skilled in the art utilizing the teachings disclosed herein.

As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” encompass embodiments having plural referents, unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.

Spatially related terms, including but not limited to, “proximate,” “distal,” “lower,” “upper,” “beneath,” “below,” “above,” and “on top,” if used herein, are utilized for ease of description to describe spatial relationships of an element(s) to another. Such spatially related terms encompass different orientations of the device in use or operation in addition to the particular orientations depicted in the figures and described herein. For example, if an object depicted in the figures is turned over or flipped over, portions previously described as below, or beneath other elements would then be above or on top of those other elements.

As used herein, when an element, component, or layer for example is described as forming a “coincident interface” with, or being “on,” “connected to,” “coupled with,” “stacked on” or “in contact with” another element, component, or layer, it can be directly on, directly connected to, directly coupled with, directly stacked on, in direct contact with, or intervening elements, components or layers may be on, connected, coupled or in contact with the particular element, component, or layer, for example. When an element, component, or layer for example is referred to as being “directly on,” “directly connected to,” “directly coupled with,” or “directly in contact with” another element, there are no intervening elements, components or layers for example.

Various examples have been described. These and other examples are within the scope of the following claims.

Claims

1. A device for a therapy unit configured to apply a negative pressure at a wound site and a canister configured to receive a fluid removed from the wound site in response to the negative pressure applied to the wound site, the device comprising: a housing adapted to be removably coupled with the therapy unit, the housing comprising at least one device airflow channel extending therethrough, wherein the at least one device airflow channel is disposed in fluid communication with the canister when the housing is removably coupled with the therapy unit; and an airflow unit configured to provide an airflow through the at least one device airflow channel, such that the airflow is directed through the canister.

2. The device of claim 1, wherein the airflow unit comprises at least one of a blower, a heater, and a dehumidifier.

3. The device of claim 1, wherein the airflow unit is disposed within the housing of the device.

4. The device of claim 1, wherein the airflow unit comprises a plurality of modules, and wherein one or more modules of the plurality of modules are removably disposed in the at least one device airflow channel.

5. The device of claim 1, further comprising a controller communicably coupled to the airflow unit, wherein the controller is configured to control the airflow unit based on an airflow rate of the airflow through the at least one device airflow channel.

6. The device of claim 5, further comprising at least one sensor configured to generate at least one signal, wherein the at least one sensor is communicably coupled to the controller, and wherein the controller is configured to determine the airflow rate based on the at least one signal.

7. The device of claim 6, wherein the at least one sensor comprises at least one of a temperature sensor, a pressure sensor, a humidity sensor, a fluid level sensor, and a weight sensor.

8. The device of claim 5, further comprising a detection sensor configured to generate a detection signal when the device is removably coupled with the therapy unit, wherein the detection sensor is communicably coupled to the controller, and wherein the controller is configured to control the airflow unit upon receiving the detection signal.

9. A system comprising: a therapy unit comprising a negative pressure source fluidly communicating with a wound site and configured to apply a negative pressure at the wound site; a canister fluidly communicating with the wound site and configured to receive a fluid removed from the wound site in response to the negative pressure applied to the wound site, wherein the canister is configured to be removably coupled with the therapy unit, and wherein the canister comprises at least one canister airflow channel extending therethrough; and a device for the therapy unit, the device comprising: a housing adapted to be removably coupled with the therapy unit, the housing comprising at least one device airflow channel extending therethrough; and an airflow unit configured to provide an airflow through the at least one device airflow channel; wherein, when the housing is removably coupled with the therapy unit, the at least one device airflow channel is in fluid communication with the at least one canister airflow channel of the canister, such that the airflow is directed through the at least one canister airflow channel.

10. The system of claim 9, wherein the airflow unit comprises at least one of a blower, a heater, and a dehumidifier.

11. The system of claim 9, wherein the airflow unit is disposed within the housing of the device.

12. The system of claim 9, wherein the airflow unit comprises a plurality of modules, and wherein one or more modules of the plurality of modules are removably disposed in the at least one device airflow channel.

13. The system of claim 9, wherein the device further comprises a controller communicably coupled to the airflow unit, and wherein the controller is configured to control the airflow unit based on an airflow rate of the airflow through the at least one device airflow channel.

14. The system of claim 13, wherein at least one of the device and the canister further comprises at least one sensor configured to generate at least one signal, wherein the at least one sensor is communicably coupled to the controller, and wherein the controller is configured to determine the airflow rate based on the at least one signal.

15. The system of claim 14, wherein the at least one sensor comprises at least one of a temperature sensor, a pressure sensor, a humidity sensor, a fluid level sensor, and a weight sensor.

16. The system of claim 13, wherein the device further comprises a detection sensor configured to generate a detection signal when the device is removably coupled with the therapy unit, wherein the detection sensor is communicably coupled to the controller, and wherein the controller is configured to control the airflow unit upon receiving the detection signal.

17. The system of claim 13, further comprising an alarm unit communicably coupled to the controller, wherein the alarm unit is configured to generate an alarm when a volume of the fluid in the canister crosses a predetermined volume threshold.

18. The system of claim 9, wherein the canister comprises: a canister body configured to store the fluid removed from the wound site; a membrane carrier comprising a plurality of through-holes disposed in fluid communication with the canister body, wherein the membrane carrier comprises the at least one canister airflow channel disposed in fluid communication with the plurality of through- holes; and at least one membrane disposed at least on the plurality of through-holes of the membrane carrier. The system of claim 18, wherein the at least one membrane is vapor permeable and liquid impermeable. The system of claim 9, further comprising a secondary canister comprising at least one secondary canister airflow channel extending therethrough, wherein the housing of the device is further adapted to be removably coupled with the secondary canister, wherein the housing further comprises at least one additional device airflow channel disposed in fluid communication with the at least one device airflow channel, and wherein when the housing is removably coupled with the secondary canister, the at least one additional device airflow channel is in fluid communication with the at least one secondary canister airflow channel, such that at least a portion of the airflow is directed through the at least one secondary canister airflow channel.