A system for monitoring the appropriate use of negative pressure injury treatment.

Abstract

To provide a system, a method and a device for monitoring compliant usage of a negative pressure wound therapy.SOLUTION: In a therapy network 100, a therapy system 102 includes: a bandage 106 that includes a cover 108, and a tissue interface 110; and a therapy unit 104 that has a negative pressure source 114, and a communication device 116. The communication device is coupled to the negative pressure source, and transmits operation data on the negative pressure source to a remote monitor center 120 for monitoring usage of the therapy system via a network 118.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present disclosure generally relates to medical systems for treating tissue sites and monitoring the use of such systems. More specifically, without limitation, the present disclosure relates to a system for monitoring compliance utilization of a negative-pressure wound therapy system.

Background Art

[0002] Clinical studies and medical practice have shown that reducing pressure in the vicinity of a tissue site can increase and accelerate the growth of new tissue at the tissue site. Although the uses of this phenomenon are innumerable, it has proven to be particularly advantageous for treating wounds. Regardless of the cause of the wound (whether due to trauma, surgery or another cause), proper care of the wound is important for the outcome. Treatment of wounds by reducing pressure is sometimes commonly referred to as "negative-pressure wound therapy", but is also known by other names including, for example, "negative-pressure wound treatment", "reduced-pressure wound treatment", "vacuum treatment", and "vacuum-assisted closure". Negative-pressure wound therapy can provide many benefits including movement of epithelial and subcutaneous tissue at the wound site, improved blood flow, and microscopic deformation of tissue. Along with these, these benefits can increase the growth of granulation tissue and reduce healing time.

[0003] Although the clinical benefits of reduced-pressure treatment are well known, the development and operation of reduced-pressure systems, components and processes continue to present significant challenges to manufacturers, healthcare providers and patients.

[0004] If a patient receiving negative-pressure wound treatment does not use the negative-pressure system in accordance with a prescribed treatment plan, the results of the treatment may not be as effective as desired. Currently, there is a lack of real-time methods for collecting such usage data to monitor compliance with treatment protocols.

Summary of the Invention

[0005] According to an exemplary embodiment, a system for monitoring the treatment of a tissue site may include a bandage, a negative pressure source, and a communication device. The bandage may be placed over the tissue site. The negative pressure source may be fluidly connected to the bandage. The communication device may be coupled to the negative pressure source and configured to transmit operational data of the negative pressure source.

[0006] According to another exemplary embodiment, an apparatus for treating a tissue site may include a negative pressure source and a communication device. The negative pressure source may be fluidly connected to the tissue site. The communication device may be coupled to the negative pressure source and may be configured to transmit operational data of the negative pressure source.

[0007] In yet another exemplary embodiment, a method for treating a tissue site may include the steps of applying a bandage to the tissue site, attaching a negative pressure source to the bandage, applying negative pressure to the bandage, and transmitting operational data related to the application of negative pressure.

[0008] Other objects, features, and advantages of the embodiments described herein will become apparent by reference to the following accompanying drawings and detailed description. [Brief explanation of the drawing]

[0009] [Figure 1] Figure 1 shows an example of a treatment network according to an exemplary embodiment. [Figure 2] Figure 2 is a perspective view showing additional details that may relate to several exemplary embodiments of the treatment units within the treatment network in Figure 1. [Figure 3] Figure 3 shows a screenshot of the graphic user interface (GUI) of the treatment unit electronic display according to an exemplary embodiment. [Figure 4] Figure 4 shows a screenshot of the graphical user interface (GUI) of usage monitoring software for operation on an electronic device, according to an exemplary embodiment. [Figure 5] Figure 5 is an illustrative flowchart of the process for monitoring the use of the wound healing system. [Modes for carrying out the invention]

[0010] The following detailed description of non-limiting exemplary embodiments refers to the accompanying drawings which form part of this specification. Other embodiments may be utilized and logical, structural, mechanical, electrical, and chemical modifications may be made without departing from the scope of the appended claims. In order to avoid detailed descriptions which are not necessary for a person skilled in the art to carry out the embodiments described herein, the description may omit some information which is known to a person skilled in the art. The following detailed description is non-limiting and the scope of exemplary embodiments is defined by the appended claims. As used herein, unless otherwise noted, “or” does not require mutual exclusivity.

[0011] Exemplary embodiments may also be described herein by reference to spatial relationships between various elements or spatial orientations of various elements depicted in the accompanying drawings. Generally, such relationships or orientations assume a reference frame that is consistent with or relative to the patient at the treatment site. However, as should be recognized by those skilled in the art, this reference frame is merely an explanatory expedient rather than a strict definition.

[0012] Figure 1 is a schematic diagram of an exemplary embodiment of a treatment network 100 that can provide monitoring of wound healing according to this specification. The treatment network 100 may include a treatment system 102 which may include a treatment unit 104 and a bandage 106. The bandage 106 may include a cover 108 and a tissue interface 110. As shown in Figure 1, the bandage 106 may be fluidly connected to a negative pressure source 114. The treatment unit 104 may also include an exudate container, such as a container 112, which is fluidly connected to the bandage 106 and the negative pressure source 114.

[0013] The treatment system 102 may also include a communication device 116. For example, the communication device 116 may be electrically coupled to the treatment unit 104, or in some embodiments may be part of the treatment unit 104. The communication device 116 may be connected to the treatment unit 104 by wire or wireless. The communication device 116 of the treatment system 102 may include a transmitter and be configured to communicate with one or more networks 118 of the treatment network 100. In one preferred embodiment, the communication device 116 may include a cellular modem and be configured to communicate with network 118 via a cellular connection. In other embodiments, the communication device 116 may include a Bluetooth® radio, a ZigBee® radio, or another wireless radio for communicating with network 118 via a personal area network (PAN) or wide personal area network (WPAN). The communication device 116 may be configured to transmit data relating to the operation of the treatment system 102, which may occur at the patient's home or at a treatment center such as a hospital or a doctor's office.

[0014] In some embodiments, the communication device 116 may be integrated into the housing of the negative pressure source 114 of the treatment unit 104. In other embodiments, the communication device may be separately mounted on the exterior of the negative pressure source 114 and may include a receiver configured to receive data related to the operation of the negative pressure source 114. In one embodiment, the communication device 116 may be mounted on the exterior of the negative pressure source 114 and connected to the negative pressure source 114 via a serial communication interface.

[0015] In some embodiments, the communication device 116 may include a processor configured with algorithms for processing data related to the operation of the treatment system 102 (specifically, the negative pressure source 114). The processor algorithm may be programmed to calculate utilization statistics based on the usage time and status of the negative pressure source 114. For example, the processor may calculate the total operating time and the average daily operating time of the negative pressure source 114 since a given patient started treatment. The processor may be configured to calculate how the average daily operating time compares to a prescribed treatment protocol and to calculate the level of compliance with the corresponding prescribed treatment protocol. Additionally, the processor may be configured to generate a warning signal based on the level of compliance with the prescribed treatment protocol, which can be transmitted via a network such as network 118 by a transmitter in the communication device 116.

[0016] The treatment network 100 may also include a remote monitoring center 120 that can communicate with the treatment system 102 via network 118. For example, a communication device 116 of the treatment system 102 may be configured to transmit data to the remote monitoring center 120 via network 118. The remote monitoring center 120 may include an automated monitoring center 122. The automated monitoring center 122 may include a communication center 124 as well as an alert center 126. The communication center 124 may be designed to monitor the communication link between the treatment system, such as the treatment system 102, and the remote monitoring center 120. In some embodiments, the communication center 124 may include a receiving unit configured to receive data relating to the operation of the treatment system 102 (more specifically, the treatment unit 104 and the negative pressure source 114). The receiving unit may include a processing unit loaded with software algorithms for processing the data relating to the operation of the treatment system 102 and for providing output calculations of how to compare the data relating to the operation of the treatment system 102 with one or more thresholds. For example, in some embodiments, the threshold may correspond to a treatment protocol that prescribes a specific minimum dose of the treatment unit 104.

[0017] The warning center 126 of the automated monitoring center 122 may be configured to receive warning notifications transmitted not only from the communication center 124 but also from treatment systems such as the treatment system 102. In some cases, the communication center 124 and / or the warning center 126 may be operated by one or more automated computers. The remote monitoring center 120 may also include a compliance team center 128. The compliance team center 128 may not only transmit warning notifications that may be reported from the warning center 126 but may also function as a service center for compliance staff, clinicians or other personnel to monitor patient use of treatment systems such as the treatment system 102.

[0018] The treatment network 100 may also include other entities that can communicate with the treatment system and the remote monitoring center via the network 118. For example, the treatment network 100 may include a third party 130, which could be an insurer. In one embodiment, the third party 130 may communicate with the remote monitoring center 120 via the network 118 to obtain usage data related to the treatment system 102. In another embodiment, the third party 130 may be able to receive usage data directly from the treatment system via the network 118 without needing to communicate with the treatment system.

[0019] Generally, the components of the treatment system 102 may be connected directly or indirectly, and in some cases, they may be connected in a separable manner. For example, the negative pressure source 114 may be directly connected to the container 112, or indirectly connected to the bandage 106 via the container 112. Components may be fluidically connected to each other to provide a pathway for supplying fluid (i.e., liquid and / or gas) between them.

[0020] In some embodiments, for example, components may be fluidly connected to a tube. As used herein, “tube” broadly refers to a tube, pipe, hose, conduit, or other structure having one or more lumens designed to carry fluid between its ends. Typically, a tube is an elongated cylindrical structure with some flexibility, although its geometric shape and rigidity can vary. In some embodiments, components may be joined together additionally or instead due to physical proximity, integrated into a single structure, or formed from the same material. Joints may also include mechanical, thermal, electrical, and chemical bonds (such as chemical bonds) in some contexts.

[0021] During operation, the tissue interface 110 may be positioned within, above, on, or in close proximity to the tissue site. The cover 108 may be positioned above the tissue interface 110 and sealed to the tissue near the tissue site. For example, the cover 108 may be sealed to the intact epidermis surrounding the tissue site. Thus, the bandage 106 may provide a sealed therapeutic environment in close proximity to the tissue site, substantially isolated from the external environment, and the negative pressure source 114 may reduce the pressure within the sealed therapeutic environment. The negative pressure applied to the tissue site through the tissue interface 110 within the sealed therapeutic environment may not only remove exudate and other fluids from the tissue site, which can be collected in the container 112 and properly disposed of, but may also induce macroscopic and microscopic strain on the tissue site.

[0022] The fluid dynamics of using a negative pressure source to reduce pressure in or at a location within another component, such as in a sealed therapeutic environment, can be mathematically complex. However, the basic principles of fluid dynamics applicable to negative pressure injury therapy are generally known to those skilled in the art.

[0023] Generally, leachates and other fluids flow in a low-pressure direction along a fluid path. Thus, the term "downstream" typically means something within a fluid path that is relatively close to a negative pressure source or further away from a positive pressure source, and conversely, the term "upstream" means something relatively far from a negative pressure source or closer to a positive pressure source. Similarly, it may be convenient to describe some features in the sense of a fluid "inlet" or "outlet" in such a reference system, and a process for reducing pressure may be illustratively described herein as, for example, "supplying", "distributing", or "generating" a reduced pressure. This orientation is typically assumed for the purpose of describing various features and components herein.

[0024] The term "tissue site" in this context broadly refers to an injury or defect on or within a tissue such as, without limitation, bone tissue, adipose tissue, muscle tissue, nerve tissue, encapsulated tissue, vascular tissue, connective tissue, cartilage, tendon, or ligament. Injuries can include, for example, chronic, acute, traumatic, subacute, lacerated, intermediate thermal, ulcers (such as diabetic ulcers, bedsores, or venous insufficiency ulcers), skin flaps, and grafts. The term "tissue site" can also refer to any tissue region that does not necessarily have an injury or defect, but instead may refer to a region where it may be desirable to increase or promote the growth of additional tissue. For example, negative pressure can be used within some tissue regions to grow additional tissue that can be excised and transplanted to another tissue location.

[0025] "Negative pressure" typically refers to a pressure less than a local ambient pressure such as the ambient pressure within a local environment outside of a sealed treatment environment provided by the dressing 106. In many cases, the local ambient pressure can also be the atmospheric pressure where the patient is located. Otherwise, the local ambient pressure can be less than the hydrostatic pressure associated with the tissue at the tissue site. Unless otherwise noted, 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.

[0026] The negative pressure source, such as negative pressure source 114, may be a storage unit of negatively pressurized air, or a manual or electric device capable of reducing pressure within a sealed volume (e.g., a vacuum pump, suction pump, wall suction port available in many healthcare facilities, or a micropump). The negative pressure source may be housed within or used in conjunction with other components such as sensors, processing units, alarm indicators, memory, databases, software, display devices, or user interfaces that further facilitate decompression therapy. The amount and nature of the negative pressure applied to the tissue site may vary depending on the treatment requirements, but the pressure is typically in the range of -5 mmHg (-667 Pa) to -500 mmHg (-66.7 kPa). The general treatment range is -75 mmHg (-9.9 kPa) to -300 mmHg (-39.9 kPa).

[0027] The tissue interface 110 can typically be made to be in contact with a tissue site. The tissue interface 110 may be in partial or complete contact with the tissue site. If the tissue site is a wound, for example, the tissue interface 110 may partially or completely fill the wound or be placed over the wound. The tissue interface 110 can take many forms and may have many dimensions, shapes or thicknesses depending on various factors such as the type of treatment being performed or the nature and dimensions of the tissue site. For example, the dimensions and shape of the tissue interface 110 may be adapted to the contour of a deeply and irregularly formed tissue site.

[0028] In some embodiments, the tissue interface 110 may be a manifold. In this context, “manifold” typically includes any substance or structure that provides multiple pathways for collecting fluid or distributing it throughout a tissue site. For example, a manifold may receive negative pressure from a negative pressure source and distribute the negative pressure throughout the tissue site through multiple openings, and may have the effect of collecting fluid from the tissue site and drawing it in the direction of the negative pressure. However, in some embodiments, the manifold may also facilitate the supply of fluid to the tissue site, for example, if the fluid pathway is reversed or a second fluid pathway is provided.

[0029] In some exemplary embodiments, pathways may be interconnected to improve the distribution or collection of fluids supplied or removed from tissue sites. For example, cellular foams, open-cell foams, porous tissue populations, and other porous materials such as gauze or felt mats typically include structural elements arranged to form channels. Liquids, gels, and other foams may also include or be cured to include channels.

[0030] In some exemplary embodiments, the manifold may be a porous foam material having interconnecting cells or pores that distribute negative pressure throughout the tissue site. The foam material may be either hydrophobic or hydrophilic. In one non-limiting example, the tissue interface 110 may be an open-cell, reticulated polyurethane foam, such as GranuFoam® bandages available from Kinetic Concepts, Inc., San Antonio, Texas, USA.

[0031] In examples where the tissue interface 110 is composed of a hydrophilic material, the tissue interface 110 can also discharge fluid from the tissue site while continuously supplying negative pressure to the tissue site. The discharge characteristics of the tissue interface 110 allow fluid to be drawn out of the tissue site by capillary flow or other discharge mechanisms. An example of a hydrophilic foam is a polyvinyl alcohol open-cell foam, such as VACWhiteFoam® bandages, available from Kinetic Concepts, Inc. in San Antonio, Texas, USA. Other hydrophilic foams may be made of polyethers. Other foams that can exhibit hydrophilic properties may be hydrophobic foams that have been treated or coated to provide hydrophilicity.

[0032] The tissue interface 110 further promotes granulation at the tissue site when the pressure within the sealed therapeutic environment is reduced. For example, any or all surfaces of the tissue interface 110 may have an irregular, rough, jagged profile that can induce micro-strains and strains at the tissue site when negative pressure is applied to the entire tissue interface 110.

[0033] In some embodiments, the tissue interface 110 may be constructed from a bioresorbable material. Suitable bioresorbable materials include, but are not limited to, polymer blends of polylactic acid (PLA) and polyglycolic acid (PGA). Other polymer blends include, but are not limited to, polycarbonates, polyfumarates, and capralactones. The tissue interface 110 may further function as a scaffold for new cell proliferation, or a scaffold material may be used in cooperation with the tissue interface 110 to promote cell proliferation. A scaffold is typically a substance or structure used to enhance or promote cell proliferation or tissue formation, such as a three-dimensional porous tissue that provides a prototype for cell proliferation. Exemplary examples of scaffold materials include calcium phosphate, collagen, PLA / PGA, coral hydroxyapatite, carbonates, or treated allograft materials.

[0034] In some embodiments, the cover 108 may provide a bacterial barrier and protection from physical trauma. The cover 108 may also be constructed of a material that can reduce evaporation loss and provide a fluid seal between two parts or between two environments, such as between a therapeutic environment and a local external environment. The cover 108 may be, for example, an impermeable or semi-permeable elastomer material that can provide a suitable seal to maintain negative pressure at a tissue site of a given negative pressure source. In some exemplary embodiments, the cover 108 may be a polymer drape, such as a polyurethane membrane that is permeable to water vapor but impermeable to liquids. Such drapes typically have a thickness in the range of 25 to 50 micrometers. With respect to permeable materials, the permeability should usually be low enough so that the desired negative pressure can be maintained.

[0035] To attach cover 108 to the mounting surface, mounting devices such as undamaged skin, gaskets, or other covers may be used. Mounting devices can take many forms. For example, a mounting device may be a medically acceptable pressure-sensitive adhesive stretched around cover 108, part of it, or all of it. In some embodiments, for example, part or all of cover 108 may be coated with an acrylic adhesive having a coating weight of 25 to 65 grams (gsm) per square meter. Thicker adhesives or combinations of adhesives may be applied in some embodiments to improve sealing and reduce leakage. Other exemplary embodiments of mounting devices may include double-sided tape, paste, hydrophilic colloid, hydrogel, silicone gel, or organic gel.

[0036] Container 112 represents a container, canister, pouch, or other storage component that may be used to manage exudate and other fluids drawn from a tissue site. In many environments, rigid containers may be preferred or necessary for the collection, storage, and disposal of fluids. In other environments, fluids may be properly disposed of without being stored in rigid containers, and reusable containers may reduce waste or costs associated with negative pressure injury treatment.

[0037] Referring to Figure 2, an exemplary example of a treatment unit 204 according to one embodiment is depicted, which may be another embodiment of the treatment unit 104. The treatment unit 204 is suitable for use as a component of the treatment system 102. The treatment unit 204 may include a housing 205 that can enclose a negative pressure source 214 and a communication device 216. The treatment unit may also include an electronic display 217 for interface with the user. The container 212 may be configured to be mounted to the housing 205 of the treatment unit 204.

[0038] Referring to Figure 3, an exemplary embodiment of the electronic display 217 of the treatment unit 204 is shown. The electronic display 217 may be configured to display a graphic user interface (GUI) 300. The GUI 300 may include many selectable graphic elements, including a “Settings” soft button 306, a “Treatment Protocol” soft button 308, a “Usage Data” soft button 310, and a “Communication” soft button 312, along with soft buttons that can be assigned to any other features related to the treatment of the tissue site. The user may select any of these features (i.e., settings, wound type, treatment protocol, usage data, communication) to have the electronic display 217 present the user with a different graphic user interface for performing the selected function. In addition, an “Exit” soft button 314 may be available to the user to exit the current GUI 300. It should be understood that the GUI 300 is exemplary and that other and / or other functions and selectable elements may be provided to the user.

[0039] The information area 316 on the GUI 300 may include selectable graphic elements and display other information of interest to the user. For example, a "Help" soft button 318 may be displayed to allow the user to obtain assistance regarding the treatment unit 204 or a specific function currently displayed on the GUI 300. A "Send" soft button 320 may allow the user to selectively activate or deactivate the communication device 216 of the treatment system 102 to begin or stop sending usage data to the network 118. An "On / Off" soft button 322 may allow the user to selectively turn the treatment unit 204 on or off. The information status area 324 may inform the user of the current status of the treatment unit 204. For example, the information status area 324 may indicate that the treatment unit 204 is (i) currently on, (ii) operating in accordance with a specially selected treatment protocol, and (iii) transmitting operational data to a remote receiver. The information status area 324 may also indicate that the communication device 216 is (i) currently activated, (ii) currently deactivated, (iii) currently transmitting data, and (iv) currently receiving data. The information status area 324 may also provide a visual indicator of the patient's compliance level with the treatment system 102 through the prescribed treatment protocol.

[0040] In some embodiments, the treatment system 102 may be configured to display availability compliance information on the user's information status area 324, or to notify caregivers or other service providers that a user, such as a patient, is complying with the prescribed treatment protocol. For example, availability compliance information may include information or data regarding whether negative pressure wound treatment is being applied to a tissue site over time. Availability compliance information may also include information or data regarding treatment event log tracking (e.g., whether the treatment system 102 is turned on or off over time). Additional compliance analysis may include information or data regarding whether the treatment system 102 is being used in accordance with the prescribed treatment protocol (e.g., a protocol defining various pressures and / or flow rates over time). Compliance analysis may also include information or data regarding the progress of wound healing over time. Additional compliance output information may include output data and information such as information that provides an audible or visual warning when non-compliance reaches an unacceptable level or threshold. Such compliance output information can also provide feedback to users, such as patients, before providing such information to others, such as clinicians, and as a result, users have the opportunity and motivation to correct non-compliant situations before they reach unacceptable levels or thresholds. Additional compliance input information may include input data and information such as information about settings or caregiver inputs entered into the treatment system 102. Such compliance input information may include data such as treatment pressure settings, maximum and minimum target pressures, flow rate settings, intensity and / or duration of any supplemental treatment such as fluid infusion, and whether negative pressure treatment is applied in continuous or intermittent operating mode.

[0041] The information status area 324 may also be configured to display messages transmitted from an indirect party to the user. For example, a clinician at the remote monitoring center 120 may send a message to the treatment system 102 via the network 118 for display to the patient. Such a message may include instructions for the treatment system 102 to be turned on and kept in use. In addition, such a message may include instructions for troubleshooting one or more problems presented to the treatment system 102. Troubleshooting instructions may include instructions for emptying or replacing the exudate container or for recharging or replacing the batteries of the treatment system 102.

[0042] Figure 4 shows a screenshot of an exemplary GUI 400 or another embodiment of GUI 300 or a portion of GUI 300 of an exemplary embodiment of usage monitoring software for use on an electronic device such as a computer having an electronic display which may be an electronic display 217 including GUI 300. This exemplary embodiment of GUI 400 provides a patient summary view 402 which includes usage compliance information embodied in a usage report display 404, a compliance analysis display 406, and compliance output information embodied in a warning management display 408. The usage report display 404 may correspond to usage data relating to the patient's treatment system, such as a treatment system 102. The patient summary view 402 may display information based on data from the treatment system's device log data. The device log data is interpreted and manipulated by the usage monitoring software in preparation for display. The usage monitoring software may analyze date and time stamped data to calculate potential non-compliant usage statistics.

[0043] The usage report display 404 may include a daily usage summary 410 that can show the user the total amount of time the treatment system is in operation per day. The usage report display 404 may also include a healing measurement results display 412. The healing measurement results display 412 may provide data for tracking the healing progress of one or more wounds in a patient. For example, the healing measurement results display 412 may display data corresponding to the percentage of healing received by a particular wound. Additionally or instead, the healing measurement results display 412 may display data relating to physical measurements of one or more wounds (such as length, width, depth, circumference, etc.).

[0044] The compliance analysis display 406 may display data and analyses relating to patient use of a treatment system, such as the treatment system 102, and how this use conforms to one or more treatment protocols. For example, compliance diagram 414 may display a comparison of “the amount of time the patient uses the treatment system daily” versus “the amount of time prescribed according to the treatment protocol.” The compliance analysis display 406 may also include a healing analysis diagram 416 that can compare the healing rate of one or more of a patient's wounds to the average healing time of similar wounds. Alternatively, the compliance analysis display 406 may display analyses relating to specific time slots during the day or night in which the treatment system is used. The compliance analysis display 406 may also display statistics relating to any other aspect of patient use of the treatment system or the healing of one or more wounds, otherwise.

[0045] The warning management display 408 may display information related to various types of warnings or alarms associated with the use of a treatment system, such as the treatment system 102. For example, the warning management display 408 may include an alarm window 418 and a communication window 420. The alarm window 418 may include one or more indicators related to various features or functions of the treatment system. For example, the alarm window 418 may include a leak detection indicator 422 that can signal to the user that a fluid leak has been detected on the patient's treatment system. The alarm window 418 may also include an obstruction detection indicator 424 that can warn the user that a fluid obstruction has been detected by the treatment system. A container fullness indicator 426 may also be included to indicate whether a container for collecting wound exudate is present or nearing full. In addition, a low battery indicator 428 may be included to signal that one or more batteries in the treatment system are nearing depletion. Furthermore, the warning management display 408 may allow for remote troubleshooting of problems with the treatment system 102.

[0046] The communication window 420 of the warning management display 408 may not only display warnings to the user regarding the connection status with one or more treatment systems, but may also provide a user interface for viewing or changing settings related to communication with the treatment systems. For example, the communication window 420 may include an uplink failure indicator 430 that can signal to the user that the communication link with the monitored treatment system has been interrupted. Configuration buttons 432 may also be included that allow the user to access menus for configuring communication and / or network settings for setting and maintaining remote monitoring capabilities of the treatment systems.

[0047] While the exemplary GUI400 in Figure 4 focuses on individual patient data, other exemplary GUIs may include reports that focus on broader patient overview data. For example, an overview of a given patient population may be provided, which could provide efficient identification of anomalous patients who may require intervention. Such an overview may involve viewing patient data at a macro level by grouping patient data by, for example, patient statistical data, payer group, injury type, or comorbidities. Providing an overview view of one or more patient populations can enable better insights into patient care at a broader scale.

[0048] In a typical home care setting, patients receiving wound treatment are visited once every 2-3 days for bandage changes, at which time the clinician can assess patient adherence to the prescribed treatment protocol. The clinician may use GUI404 and the above features of the treatment system 102 and / or additionally visually inspect the tissue site to make such an assessment. However, visiting the patient once every 2-3 days is not the optimal timing to determine whether the patient has used the negative pressure wound treatment system as prescribed (e.g., for the recommended number of treatment hours per day). Often, providers and insurers expect patients to use the negative pressure wound treatment system 24 hours a day, but actual use by some patients may be much less. Since there is no way to collect this usage data, the extent of adherence issues is largely unknown. Today, it is understood that non-adherence below certain thresholds can affect patient healing.

[0049] As disclosed herein, the treatment network 100 improves the operation of negative pressure injury treatment. For example, by providing a system for remotely monitoring compliance with the use of the negative pressure injury treatment system, non-compliant use can be detected more quickly so that caregivers and patients can be advised more quickly to use the treatment system as prescribed. As a result, improved compliance with the treatment protocol may be achieved, and faster healing of the tissue site may be achieved. For example, a clinical care team or home nurse may be able to contact the monitored patient to provide instructions for compliance with a given prescribed treatment.

[0050] During operation, the treatment network 100 and its various components and features may be utilized according to exemplary embodiments of the monitoring method 500 shown in Figure 5. For example, operation of the treatment network 100 may be initiated by starting the operation of a treatment system, such as a treatment system 102. A bandage, such as a bandage 106 of the treatment system 102, may be applied to a tissue site as shown in step 502. Next, negative pressure may be applied to the bandage and the tissue site by fluidly connecting a negative pressure source, such as a negative pressure source 114, to the bandage and then activating the negative pressure source, as shown in step 504. Step 506 provides a step of activating the communication capabilities of the treatment system and establishing communication with one or more remote monitoring centers to begin transmitting data, such as utilization data.

[0051] Once the treatment system begins transmitting data, the usage data can be received and analyzed at a remote location, such as a remote monitoring center, as shown in step 508. A user at the remote location (e.g., a clinician or compliance team member) can examine the usage data transmitted from the treatment system related to a specific patient via a GUI. In some cases, the GUI may be viewed on a computer device such as a desktop terminal. In other cases, the GUI may be viewed on a personal wireless device such as a smartphone using a custom-developed software application.

[0052] In some preferred embodiments, such usage data, particularly usage compliance information, may include when a treatment unit, such as a treatment unit 204, was turned on or off. In other embodiments, such usage compliance information may further include whether a communication device, such as a communication device 216, was activated or deactivated during a given period, and / or, if activated, whether the communication device 216 transmitted data to a remote receiver. In addition, the received usage compliance information may be analyzed to determine whether it conforms to desired usage data to be transmitted.

[0053] By reviewing such usage compliance information, the user can determine, as shown in step 510, whether the patient's use of the treatment system complies with one or more predetermined protocols. In some embodiments, automated monitoring capabilities may be employed, and this compliance determination may be made automatically. If the compliance assessment determines that the patient's treatment system is being used according to a given predetermined protocol, step 508 may be repeated according to a routine that monitors the schedule. Alternatively, if the compliance assessment performed in step 510 indicates that "the patient's treatment system is not being used in accordance with the prescribed treatment protocol," a warning may be signaled at the remote monitoring center, as shown in step 512.

[0054] For example, if a patient prescribed 24 hours / day negative pressure wound therapy for a wound is only using the negative pressure therapy system for approximately 14 hours / day, a remote monitoring center can detect this discrepancy between prescribed and actual treatment. In some preferred embodiments, threshold warnings may be issued when the utilization of negative pressure wound therapy falls below 16 to 20 hours / day, depending on other treatment factors and the wound condition. For example, the input compliance threshold may be set at 18 hours / day if the compliance team determines that the current treatment is generating a large amount of exudate from the wound and may be interfering with the healing process. In another example, the input compliance threshold may be set at 16 hours / day to adapt to the management of fluid infusion therapy. In any of the embodiments, the warning threshold limit may be adjusted to address other factors that may affect the management of negative pressure wound therapy.

[0055] While it is often preferable for patients to receive negative pressure wound therapy for as long as possible, ideally 24 hours / day, the utilization reference thresholds discussed above can be set based on experimental data demonstrating that utilization time is crucial for wound healing progress. Wound healing progress can be measured by the percentage of wound volume reduction per day (i.e., wound volume reduction). Studies that have generated experimental data have shown that "wound volume reduction can be accelerated by the percentage of 24 hours per day during which negative pressure wound therapy is administered (i.e., utilization percentage)." Furthermore, there can be significant differences in wound volume reduction between several utilization percentage values, indicating which utilization percentage values ​​or ranges should be the target thresholds for utilization reference.

[0056] As can be seen from the data in Table 1, one critical threshold can exist within the 60-69% utilization percentage range (approximately 14.5-16.5 hours per day) and the 70-79% utilization percentage range (approximately 17-19 hours per day). Therefore, based on this data, in order to achieve a desired daily wound volume reduction of more than approximately 1.5%, users should adhere to a negative pressure wound treatment compliance threshold of at least approximately 70% (i.e., approximately 17 hours per day), thereby avoiding warnings of non-compliance. TIFF0007888642000001.tif78161

[0057] In addition to warnings signaled at the remote monitoring center, automated user messages may be initiated by the remote monitoring center and sent to the treatment system, as shown in step 514. For example, user messages received by the treatment system may be automatically displayed on the treatment system's GUI. In some embodiments, chimes or other forms of warnings may be accompanied by the display of a message to attract the user's attention. In other embodiments, user messages may be sent to the user via the network by other means from the remote monitoring center. Some examples of other message formats for communication include sending text messages to a specific user's recorded telephone number. Similarly, emails may be sent to an address in the user's file. In another embodiment, automated telephone messages may be delivered to the user's recorded telephone number.

[0058] Following such messages delivered to users, usage monitoring may follow, as shown in step 516, to detect indicators of improvement in compliance with the treatment protocol. Step 518 indicates that: Usage data may be analyzed again, similar to the type of data analysis performed in step 510, to determine whether the patient has improved their compliance with the treatment system in accordance with a given treatment protocol (e.g., whether a specified usage threshold, such as 20 hours / day, is met). In some cases, the determination of whether a specified usage threshold is met or exceeded may be evaluated on a daily basis or as an average value over a multi-day period. For example, the daily wound volume percentage reduction shown in Table 1 may be determined by averaging the wound volume percentage reduction over a period of several days. In addition, the specified usage threshold may change over time, such as increasing or decreasing from one week to another. For example, if a particular tissue site shows significant healing progress, the threshold may be decreased. On the other hand, if healing progress is less than desired, perhaps due to a lack of compliance with a given treatment protocol, the specified usage threshold may be increased for a certain period.

[0059] In one embodiment, a warning is issued if the usage per day falls below 14 hours. In another embodiment, a warning is issued if the usage per day falls below 16 or 18 hours, or if the usage per day falls within the range of 14 to 22 hours. Alternatively or additionally, a warning may be issued if the average usage over a multi-day period falls below 14, 16, or 18 hours, or if the average usage falls within the range of 14 to 22 hours. For example, if the usage averages below 15 hours over three days, or below 17 hours over three days.

[0060] The threshold for issuing a warning can be adjusted over time. In one embodiment, the threshold is set to a first higher range, for example, 18 to 22 hours. Subsequently, the threshold can be set to a lower range, for example, 14 to 16 hours. Alternatively, the threshold can be adjusted based on signals received by the user or caregiver. For example, if the system receives signals indicating a high-risk patient, such as a patient who has just started treatment, a patient with an infectious wound, or a patient with one or more comorbidities, the system will utilize a higher utilization threshold. If the system receives different signals from the user or patient, the system may set a lower utilization threshold. Low-risk patient signals may be received for patients who have complied, patients with healing or fully healed wounds, or patients who are frequently visited by caregivers.

[0061] For example, if a signal indicating improved compliance is received, or if the system determines that compliance has improved, a routine monitoring the treatment system usage schedule may be restarted, as shown in step 508. If analyzed usage data indicates that compliance with a given treatment protocol has not improved, a clinician or other compliance team member may be alerted, as shown in step 520. For example, in some embodiments, an alert may be triggered at an alert center 126 in an automated monitoring center 122 and then transmitted to a compliance team center 128 in a remote monitoring center 120. Upon reviewing the alert, a clinician or other compliance team member may contact the patient to attempt to improve compliance with the treatment protocol, as shown in step 522. Furthermore, patients monitored by or assigned to a given clinician may be prioritized based on the severity of their non-compliance.

[0062] As used herein, “use” refers to the time when a medical device is turned on. Otherwise, “use” may mean the time when a treatment is provided. In another embodiment, “use” may be measured by the time when the device is providing a targeted treatment. For example, signals received by the system may indicate use by a sensor transmitting a message that the device has been turned on or off or that the pump has been turned on or off. The medical device may store data on use and then transmit signals to the system indicating use hourly, daily, or over a multi-day period.

[0063] Following such contact by a clinician or other compliance team member, compliance use monitoring may continue as shown in step 524. Similarly, step 526 indicates that use data may continue to be analyzed in the same manner as the data analysis performed in steps 510 and 518. Again, if compliance is determined to have improved, the routine of monitoring treatment system use may be resumed in accordance with step 508. If compliance with the prescribing treatment protocol does not improve, a warning regarding non-compliance may be raised within the compliance monitoring team as shown in step 528, and as a result, other actions may be taken to improve patient care.

[0064] The systems and methods described herein may offer significant advantages, some of which have already been mentioned. For example, current methods for monitoring patient compliance require the patient to personally review device event logs at the patient's bedside. Manual calculations and analyses are required to determine the amount of non-compliant time. In some cases, clinicians may spend up to 10 minutes performing calculations and analyses to determine 2-3 days of device use, which is impractical in modern healthcare environments. As a solution, a telemedicine network, as described above, provides clinicians with immediate access to patient compliance information wherever the internet is available (desktop computers, smartphones, smart tablets, etc.). The treatment network 100 may provide analysis of data output to provide caregiver information in a meaningful format. No calculations are required, and clinicians can be alerted to provide feedback to the patient to improve compliance, if necessary. Based on the data studied, it is expected that the present invention will improve wound healing compared to standard standalone negative pressure wound treatment.

[0065] The treatment network 100 can provide improved patient monitoring. For example, device log data can be viewed remotely by numerous stakeholders, which can increase the frequency of interaction with a given patient. As a result, providers can adjust treatment protocols more quickly, which can lead to reduced tissue healing time and lower overall treatment costs.

[0066] While several descriptive, non-limiting, and exemplary embodiments have been presented, various modifications, substitutions, reordering, and alternatives may be made without departing from the scope of the appended claims. Any feature described in relation to any one exemplary embodiment may also be applicable to any other exemplary embodiment.

[0067] Furthermore, the steps of the methods described herein may be performed in any preferred order, or, where appropriate, simultaneously.

Claims

1. A system for monitoring negative pressure therapy, It is a treatment unit, A negative pressure source configured to be fluidly connected to the bandage, A communication device capable of transmitting operational data of the aforementioned treatment unit, A treatment unit including, A receiving unit configured to receive operational data from the aforementioned treatment unit, A processor configured to process operational data received by the receiving unit and provide an output determination indicating whether the usage time of the treatment unit meets a threshold of a first range, wherein the processor is further configured to update the first range to a second range based on a desired wound volume reduction. Includes, The system is characterized in that the threshold corresponds to the conformal use of the treatment unit configured to achieve the desired wound volume reduction.

2. The system according to claim 1, characterized in that the threshold is 16 hours / day to 19 hours / day.

3. The system according to claim 1, characterized in that the threshold is 17 hours / day to 18 hours / day.

4. The system according to claim 1, characterized in that the threshold is 17 hours / day.

5. The system according to claim 1, characterized in that the threshold is 18 hours / day.

6. In the system described in claim 1, The system is characterized in that, in response to a determination that the usage time of the treatment unit does not meet the threshold, the processor is configured to initiate an automatic user message to the communication device.

7. In the system described in claim 1, The system is characterized in that, in response to a determination that the usage time of the treatment unit does not meet the threshold, the processor is configured to initiate a text message to the telephone number associated with the user of the treatment unit.

8. In the system described in claim 1, The system is characterized in that, in response to a determination that the usage time of the treatment unit does not meet the threshold, the processor is configured to initiate an email to the email address associated with the user of the treatment unit.

9. In the system described in claim 1, The system is characterized in that, in response to a determination that the usage time of the treatment unit does not meet the threshold, the processor is configured to initiate a telephone message to the telephone number associated with the user of the treatment unit.

10. A receiving unit for monitoring negative pressure therapy, It includes a processor, and the processor is Receive operational data transmitted from the communication device associated with the treatment unit. The system processes operational data and provides an output determination to determine whether the usage time of the treatment unit meets a threshold within a first range. Based on the desired reduction in wound volume, the first range is updated to the second range. It is configured in such a way, The receiving unit is characterized in that the threshold corresponds to the conformal use of the treatment unit configured to achieve the desired wound volume reduction.

11. A receiving unit according to claim 10, In response to the fact that the usage time of the treatment unit is less than the threshold, the processor: Automatic user message to the aforementioned communication device, A text message to the phone number in the user record of the aforementioned treatment unit, An email to the email address associated with the user, or, Phone message to the aforementioned phone number A receiving unit characterized by being configured to initiate

12. A system for monitoring negative pressure therapy, It is a treatment unit, A negative pressure source configured to be fluidly connected to the bandage, A communication device capable of transmitting operational data of the aforementioned treatment unit, A treatment unit including, A receiving unit configured to receive operational data from the aforementioned treatment unit, A processor configured to process operational data received by the receiving unit and calculate a first usage statistic for at least a first period and a second usage statistic for a second period after the first period, A remote monitoring center configured to send an alarm signal if compliance with a predetermined protocol does not improve in the second usage statistics compared to the first usage statistics, A system characterized by including

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