CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to United Kingdom Patent Application No. GB 1909551.2, filed on Jul. 3, 2019, and United Kingdom Patent Application No. GB 1916553.9, filed on Nov. 14, 2019, the disclosure of each of which is incorporated by reference in its entirety.

FIELD

Aspects of the present disclosure relate to apparatuses, systems, and methods for the treatment of wounds via negative pressure wound therapy. In some aspects, the present disclosure relates generally to reducing human error in the treatment of wounds with negative pressure wound therapy.

BACKGROUND

Many different types of wound dressings are known for aiding in the healing process of a human or animal. These different types of wound dressings include many different types of materials and layers, for example, pads such as gauze pads or foam pads. Topical negative pressure (“TNP”) therapy, sometimes referred to as vacuum assisted closure, negative pressure wound therapy, or reduced pressure wound therapy, is widely recognized as a beneficial mechanism for improving the healing rate of a wound. Such therapy is applicable to a broad range of wounds such as incisional wounds, open wounds and abdominal wounds or the like.

TNP therapy assists in the closure and healing of wounds by reducing tissue edema; encouraging blood flow; stimulating the formation of granulation tissue; removing excess exudates, and may reduce bacterial load and thus reduce the potential for infection of the wound. Furthermore, TNP therapy permits less outside disturbance of the wound and promotes more rapid healing. A medical device (e.g., a TNP therapy device) can include a user interface that allows a user to set or control the operation of the medical device. The user interface can be complex, making it difficult for a user to select the correct settings for the operation of the medical device as well as for determining if TNP therapy is delivered correctly. A need exists for simplifying the process by which a user sets or controls the operation of a medical device. A further need exists for reliable detection of the status of TNP therapy.

SUMMARY

Embodiments of the present disclosure relate to apparatuses and methods for wound treatment. Some of the wound treatment apparatuses described herein comprise a pump system or assembly for providing negative pressure to a wound site. The pump assembly can include a source of negative pressure. Wound treatment apparatuses may also comprise wound dressings that may be used in combination with the pump assemblies described herein, and connectors for connecting the wound dressings to the pump assemblies.

Some aspects of the present disclosure are directed to a negative pressure wound therapy system. A negative pressure wound therapy system can include a plurality of wound dressings configured to cover a plurality of wounds. The system can include a plurality of pressure sensors configured to be positioned in a plurality of fluid flow paths fluidically connecting the plurality of wound dressings to a negative pressure wound therapy device. The negative pressure wound therapy device can include a negative pressure source configured to be fluidically connected to the plurality of wound dressings via the plurality of fluid flow paths. The negative pressure source can be configured to aspirate fluid from the plurality of wounds. The negative pressure wound therapy device can include a controller configured to pair with the plurality of pressure sensors. The controller can be configured to provide a first indication of loss of negative pressure in a first wound of the plurality of wounds in response to a determination that a first pressure signal received from a first pressure sensor positioned in a first fluid flow path fluidically connecting the first wound to the negative pressure wound therapy device satisfies a first pressure threshold indicative of a minimum negative pressure level at the first wound.

The system of any of the preceding paragraphs and/or any of the systems disclosed herein can include one or more of the following features. The system can include a plurality of conduits configured to fluidically connect the plurality of wound dressings to the negative wound therapy device. At least one or all pressure sensors of the plurality of pressure sensors can be configured to be positioned on or within a respective conduit of the plurality of conduits. At least one or all conduits of the plurality of conduits can be made from substantially non-rigid material. The controller can be configured to provide a second indication of loss of negative pressure in a second wound of the plurality of wounds in response to a determination that a second pressure signal received from a second pressure sensor positioned in a second fluid flow path fluidically connecting the second wound to the negative pressure wound therapy device satisfies a second pressure threshold indicative of minimum negative pressure level at the second wound. The second wound can be different than the first wound. The second indication can be different than the first indication. The first and second pressure thresholds can be the same.

The system of any of the preceding paragraphs and/or any of the systems disclosed herein can include one or more of the following features. One or more of the first or second indications can include one or more of a visual alarm, audible alarm, tactile alarm, or communication of data to a remote computing device. The system can include a plurality of indicators associated with the plurality of wounds. First indication can include activation of a first indicator of the plurality of indicators to indicate loss of negative pressure in the first wound. First indicator can be associated with the first wound. First indicator can be positioned in a first conduit associated with the first wound dressing. First indicator can be configured to generate a visual indication. First indicator can be positioned at least partially within the first conduit and be at least partially covered by a substantially translucent material. The indicators can be integrated into the pressure sensors.

The system of any of the preceding paragraphs and/or any of the systems disclosed herein can include one or more of the following features. Negative pressure wound therapy device can include an inlet in fluidic communication with the negative pressure source and an additional pressure sensor configured to measure pressure in the inlet. The system can include a connector with a first branch configured to be connected to the inlet and a plurality of second branches configured to be connected to the plurality of fluid flow paths. At least one or all pressure sensors of the plurality of pressure sensors can be configured to wirelessly communicate with the controller. At least one or all indicators if the plurality of indicators can be configured to wirelessly communicate with the controller.

A negative pressure wound therapy system can include a wound dressing, a pump assembly, and a conduit configured to fluidically connect the wound dressing to the pump assembly. The wound dressing can include a sensor. The pump assembly can include a controller and optionally an alarm system. The sensor can be configured to wirelessly communicate a dressing identifier and/or other wound dressing information to the controller. The controller can be configured to automatically adjust one or more operational parameters of the pump based on the dressing identifier and/or the other wound dressing information wirelessly communicated.

The system of any of the preceding paragraphs and/or any of the systems disclosed herein can include one or more of the following features. The sensor can be a pressure sensor. The controller can be configured to automatically adjust an alarm threshold on the alarm system based on the dressing identifier and/or the other wound dressing information wirelessly communicated. The sensor can be adapted to transmit a temperature reading to the controller. The dressing identifier and other wound dressing information can inform the controller of at least one of the pieces of information selected from the group consisting of: a mode of operation of the pump, a size of the dressing, a leak rate of a controlled leak path of the dressing, a contact layer type of the dressing, an optimum negative pressure to apply to the dressing. The sensor can be adapted to inform the controller of a duration that the dressing has been active, or an average pressure, or a flow rate. The dressing can include a controlled leak path. The controller can be configured to lockout operation of the pump assembly based on the dressing identifier and other wound dressing information and on whether the pump assembly detects a canister connected to the pump assembly. The controller can be configured to lockout operation of the pump assembly based on the dressing identifier and other wound dressing information informing the controller that the dressing has been in use for an intended duration of use.

Embodiments or arrangements of the present disclosure are described for illustrative purposes in the context of methods and systems for treating a wound with topical negative pressure (TNP) therapy. However, the present disclosure is not limited to medical devices that are used for TNP therapy and can be applied to medical devices other than medical devices that are used for TNP therapy. The present disclosure can be implemented, for example, in the context of blood glucose monitoring devices, dialysis machines, or other medical devices.

A negative pressure wound therapy system can include at least one wound dressing configured to be positioned over a wound. The at least one wound dressing can include electronic circuitry. The system can include a negative pressure wound therapy device. The device can include a negative pressure source configured to provide negative pressure to the wound. The device can include a controller configured to operate the negative pressure source. The electronic circuitry can be configured to monitor a time duration during which the at least one wound dressing has been in use and communicate to the controller dressing usage information. The controller can be configured to automatically adjust one or more operational parameters of the negative pressure wound therapy device based the dressing usage information.

The system of any of the preceding paragraphs and/or any of the systems disclosed herein can include one or more of the following features. The controller can be configured to, responsive to an indication from the electronic circuitry that the time duration during which the at least one wound dressing has been in use satisfies an operational lifetime of the at least one wound dressing, at least one of disable operation of the negative pressure source or provide a dressing change indication. The electronic circuitry can include a pressure sensor configured to monitor pressure proximal to the wound. The electronic circuitry can be configured to initiate monitoring of the time duration during which the at least one wound dressing has been in use responsive to a determination of at least one of initial activation of the negative pressure source or initial attainment of a threshold negative pressure level proximal to the wound. The determination of the initial attainment of the threshold negative pressure level can be made based on one or more readings of the pressure sensor. The electronic circuitry can be configured to pause monitoring the time duration during which the at least one wound dressing has been in use responsive to receiving an indication from the controller that provision of negative pressure by the negative pressure source has been interrupted. The electronic circuitry can be configured to resume monitoring the time duration during which the at least one wound dressing has been in use responsive to receiving an indication from the controller that provision of negative pressure by the negative pressure source has been resumed.

The system of any of the preceding paragraphs and/or any of the systems disclosed herein can include one or more of the following features. The electronic circuitry can be configured to provide an indication of the time duration during which the at least one wound dressing has been in use. The indication can include at least one of auditory, visual, or tactile indication. The electronic circuitry is configured to provide the indication responsive to a determination that the time duration during which the at least one wound dressing has been in use satisfies a duration threshold, the duration threshold being shorter than an operational lifetime of the at least one wound dressing. The indication can be provided via at least one of the negative pressure wound therapy device or the at least one wound dressing. The electronic circuitry can be configured to communicate to the controller a dressing identifier. The dressing identifier can include at least one of: a mode of operation of the negative pressure source, a size of the at least one wound dressing, a leak rate of a controlled leak of the at least one wound dressing, a wound contact layer type of the at least one wound dressing, an optimum negative pressure to apply to the wound, or an operational lifetime of the at least one wound dressing. The electronic circuitry can include memory configured to store the dressing identifier. The controller can be configured to automatically adjust an alarm threshold based on the dressing identifier. The controller can be configured to disable operation of the negative pressure source based on at least one of: the dressing identifier indicating canisterless operation and responsive to a detection of a canister being fluidically connected to the negative pressure source or the dressing identifier indicating operation with the canister and responsive to a detection of the canister not being fluidically connected to the negative pressure source.

The system of any of the preceding paragraphs and/or any of the systems disclosed herein can include one or more of the following features. The electronic circuitry can be configured to communicate to the controller at least one of an average pressure or a flow rate. The controller can be configured to automatically adjust the one or more operational parameters of the negative pressure wound therapy device based on the at least one of the average pressure or the flow rate. The electronic circuitry can be configured to wirelessly communicate with the controller. The at least one wound dressing can include a plurality of wound dressings. Each wound dressing of the plurality of wound dressings can include the electronic circuitry. The controller can be configured to at least one of: automatically adjust one or more operational parameters of the negative pressure wound therapy device based on one or more time durations during which the plurality of wound dressings have been in used or generate an indication responsive to a determination that therapy settings associated with at least some wound dressings of the plurality of wound dressings are incompatible.

A method of operating a negative pressure wound therapy system can include, by electronic circuitry of at least one wound dressing configured to be positioned over a wound and connected to a negative pressure source configured to provide negative pressure to the wound, monitoring a time duration during which the at least one wound dressing has been in use and communicating dressing usage information to a controller of a negative pressure wound therapy device. The method can include, by the controller of the negative pressure wound therapy device, automatically adjusting one or more operational parameters of a negative pressure wound therapy device based the dressing usage information.

The method of any of the preceding paragraphs and/or any of the methods disclosed herein can include one or more of the following features. The method can include, by the controller, responsive to an indication from the electronic circuitry that the time duration during which the at least one wound dressing has been in use satisfies an operational lifetime of the at least one wound dressing, performing at least one of: disabling operation of the negative pressure source or providing a dressing change indication. The electronic circuitry can be configured to monitor pressure proximal to the wound. The method can include, by the electronic circuitry, initiating monitoring of the time duration during which the at least one wound dressing has been in use responsive to determining at least one of: initial activation of the negative pressure source or initial attainment of a threshold negative pressure level proximal to the wound. The method can include, by the electronic circuitry, pausing monitoring the time duration during which the at least one wound dressing has been in use responsive to receiving an indication from the controller that provision of negative pressure by the negative pressure source has been interrupted. The method can include, by the electronic circuitry, resuming monitoring the time duration during which the at least one wound dressing has been in use responsive to receiving an indication from the controller that provision of negative pressure by the negative pressure source has been resumed.

The method of any of the preceding paragraphs and/or any of the methods disclosed herein can include one or more of the following features. The method can include, by the electronic circuitry, providing an indication of the time duration during which the at least one wound dressing has been in use responsive to determining that the time duration during which the at least one wound dressing has been in use satisfies a duration threshold, the duration threshold being shorter than an operational lifetime of the at least one wound dressing. The at least one wound dressing can include a plurality of wound dressings. Each wound dressing of the plurality of wound dressings can include the electronic circuitry. The method can include, by the controller, performing at least one of: automatically adjusting one or more operational parameters of the negative pressure wound therapy device based on one or more time durations during which the plurality of wound dressings have been in used or generating an indication responsive to determining that therapy settings associated with at least some wound dressings of the plurality of wound dressings are incompatible.

Any of the features, components, or details of any of the arrangements or embodiments disclosed in this application, including without limitation any of the pump embodiments and any of the negative pressure wound therapy embodiments disclosed below, are interchangeably combinable with any other features, components, or details of any of the arrangements or embodiments disclosed herein to form new arrangements and embodiments.

