System for monitoring compliance with use of negative pressure wound therapy

Abstract

The present application relates to systems for monitoring compliant use of negative pressure wound therapy. Systems, methods, and devices for treating a tissue site are described. In some embodiments, the system can include a dressing, a negative pressure source, and a communication device. The communication device can be coupled to the negative pressure source and configured to transmit operational data of the negative pressure source to a remote location for monitoring use of the system.

Description

[0001] This application is a divisional application of the application filed on October 13, 2015, with application number 201580055376.5 and invention title "System for Monitoring Compliance Use of Negative Pressure Wound Therapy". Technical Field

[0002] This disclosure generally relates to medical treatment systems for treating tissue sites and to monitoring the use of such systems. More specifically, but not limitingly, this disclosure relates to a system for monitoring the compliant use of negative pressure wound therapy systems. Technical Background

[0003] Clinical research and practice have shown that reducing pressure near a tissue site can promote and accelerate the growth of new tissue at that site. This phenomenon has many applications, but it has proven particularly beneficial for wound treatment. Regardless of whether the wound is caused by trauma, surgery, or other factors, proper wound care is crucial for outcome. Wound treatment using decompression techniques is often called "negative pressure therapy," but it is also known by other names such as "negative pressure wound therapy," "decompression wound therapy," "vacuum therapy," and "closed negative pressure drainage." Negative pressure therapy can provide many benefits, including epithelial and subcutaneous tissue migration, improved blood flow, and micro-deformation of tissue at the wound site. These benefits can collectively increase granulation tissue development and reduce healing time.

[0004] Although the clinical benefits of decompression therapy are widely known, the development and operation of decompression systems, components, and processes have always presented significant challenges for manufacturers, healthcare providers, and patients.

[0005] If patients undergoing negative pressure wound therapy do not use the negative pressure system according to the prescribed treatment plan, the treatment outcome may not be as effective as expected. Currently, there is a lack of real-time methods for collecting such usage data to monitor compliance with treatment protocols.

[0006] Brief Overview

[0007] According to an illustrative embodiment, a system for monitoring treatment of a tissue site may include a dressing, a negative pressure source, and a communication device. The dressing may be adapted for placement on the tissue site. The negative pressure source may be fluidly coupled to the dressing. The communication device may be coupled to the negative pressure source and configured to transmit operational data of the negative pressure source.

[0008] According to another illustrative embodiment, an apparatus for treating a tissue site may include a negative pressure source and a communication device. The negative pressure source may be adapted for fluid communication with the tissue site. The communication device may be coupled to the negative pressure source and configured to transmit operational data of the negative pressure source.

[0009] According to yet another illustrative embodiment, a method for treating a tissue site may include: applying a dressing to the tissue site, connecting a negative pressure source to the dressing, applying negative pressure to the dressing, and transmitting operational data related to the application of the negative pressure.

[0010] Other objects, features, and advantages of the embodiments described herein will become apparent from the following accompanying drawings and detailed description.

[0011] This application also relates to the following.

[0012] 1) A system for monitoring negative pressure therapy on tissue sites, comprising:

[0013] Negative pressure source;

[0014] A dressing, fluidly connected to the negative pressure source and adapted for placement on the tissue site to distribute negative pressure; and

[0015] A communication device, which is connected to the negative pressure source and configured to transmit operating data of the negative pressure source.

[0016] 2) The system as described in 1), wherein the communication device is enclosed within the negative pressure source.

[0017] 3) The system as described in 1) further includes a container fluidly connected to the negative pressure source and the dressing and configured to collect fluid.

[0018] 4) The system as described in 1) further includes a connection interface configured to fluidly connect the negative pressure source to the dressing.

[0019] 5) The system as described in 1), wherein the dressing comprises:

[0020] Tissue interface, the tissue interface being adapted for placement adjacent to the tissue site; and

[0021] A cover, which is adapted to be placed above the tissue interface.

[0022] 6) The system as described in 1), wherein the communication device further comprises:

[0023] A receiver configured to receive operating data from the negative pressure source;

[0024] A processor configured to process the runtime data to calculate one or more usage statistics; and

[0025] A transmitter configured to transmit one or more usage statistics to a remote receiver to provide a warning signal indicating the degree of compliance with a prescribed protocol.

[0026] 7) The system as described in 6), wherein one or more usage statistics indicate whether the usage time of the negative pressure source meets a threshold.

[0027] 8) The system as described in 7), wherein the threshold is in the range of approximately 14 hours / day to 22 hours / day.

[0028] 9) The system as described in 8), wherein the threshold is approximately 14 hours / day.

[0029] 10) The system as described in 8), wherein the threshold is approximately 16 hours / day.

[0030] 11) The system as described in 8), wherein the threshold is approximately 18 hours / day.

[0031] 12) The system as described in 6), wherein the communication device is further configured to receive data from the remote receiver.

[0032] 13) The system as described in 6), wherein the operating data is the on and off state of the negative pressure source.

[0033] 14) A negative pressure device for treating tissue sites, comprising:

[0034] A negative pressure source, adapted for fluid communication with the tissue site; and

[0035] A communication device connected to the negative pressure source and configured to transmit operating data of the negative pressure source, wherein the operating data indicates whether the usage time of the negative pressure device meets a threshold.

[0036] 15) The negative pressure device as described in 14) further includes an electronic display configured to display the operating data.

[0037] 16) The negative pressure device as described in 15), wherein the electronic display is a touch screen display, the touch screen display being configured to allow a user to control the transmission of the operating data.

[0038] 17) The negative pressure device as described in 14), wherein the electronic display is further configured to display a warning indicator.

[0039] 18) The negative pressure device as described in 17), wherein the warning indicator is linked to the usage time of the negative pressure device.

[0040] 19) The negative pressure device as described in 17), wherein the warning indicator is associated with at least one of the following: battery level, fluid blockage, or container fill level.

[0041] 20) The negative pressure device as described in 14), wherein the communication device includes a cellular modem.

[0042] 21) The negative pressure device as described in 14), wherein the communication device includes a wireless device configured for communication on a personal area network.

[0043] 22) The negative pressure device as described in 14), wherein the threshold is set based on a signal received from the patient or caregiver.

[0044] 23) The negative pressure device as described in 14), wherein the threshold is in the range of about 14 hours / day to 22 hours / day.

[0045] 24) The negative pressure device as described in 23), wherein the threshold is approximately 15 hours / day.

[0046] 25) The negative pressure device as described in 23), wherein the threshold is approximately 17 hours / day.

[0047] 26) The negative pressure device as described in 23), wherein the threshold is approximately 19 hours / day.

[0048] 27) A method for treating a tissue site, the method comprising:

[0049] Apply the dressing to the tissue site;

[0050] Connect the negative pressure source to the dressing;

[0051] Apply negative pressure to the dressing; and

[0052] Transmit operational data related to the application of the negative pressure.

[0053] 28) The method as described in 27) further includes receiving the transmitted operational data at a remote receiver.

[0054] 29) The method as described in 28), wherein the received operating data includes the usage data of the negative pressure source.

[0055] 30) The method as described in 27), wherein the operating data is transmitted when the negative pressure is applied to the dressing.

[0056] 31) The method as described in 27), wherein the operating data is collected and transmitted while negative pressure is applied until the dressing is completed.

[0057] 32) The method as described in 28) further includes receiving data from a remote receiver.

[0058] 33) The method as described in 27), wherein the operating data indicates whether the usage time of the negative pressure source meets a threshold.

[0059] 34) The method as described in 33), wherein the threshold is in the range of approximately 14 hours / day to 22 hours / day.

[0060] 35) The method as described in 34), wherein the threshold is approximately 17 hours / day.

[0061] 36) The method as described in 33), wherein the threshold represents an average value over a multi-day period.

[0062] 37) The method as described in 27) further includes: remotely troubleshooting one or more identified tissues using a treatment system based on the transmitted operational data.

[0063] 38) The method as described in 33) further includes: generating a warning if the usage time of the negative pressure source is less than the threshold.

[0064] 39) The method as described in 27), wherein the operating data includes an indication that one or more operating parameters are outside the expected range.

[0065] 40) The method as described in 39), wherein the operating parameters include negative pressure measurement results.

[0066] 41) The method as described in 39), wherein the operating parameters include leak detection measurement results.

[0067] 42) The method as described in 39) further includes signaling a warning based on the indication.

[0068] 43) A method for treating a tissue site, the method comprising:

[0069] Activate a negative pressure source configured to provide negative pressure to the tissue site;

[0070] Transmit data related to the usage time of the negative pressure source;

[0071] It is determined that the usage time is less than the threshold.

[0072] A warning is generated to signal that the usage time is less than the threshold.

[0073] 44) The method as described in 43), wherein the threshold is in the range of approximately 14 hours / day to 22 hours / day.

[0074] 45) The method as described in 44), wherein the threshold is approximately 17 hours / day.

[0075] 46) The method as described in 43), wherein the usage time is an average of hours per day from two or more days.

[0076] 47) A method for treating a tissue site, the method comprising:

[0077] Activate the negative pressure source;

[0078] Data related to the usage time of the negative pressure source is transmitted to a remote user; and

[0079] A threshold is generated based on the data related to the usage time.

[0080] 48) The method as described in 47), wherein the threshold is the number of hours per day greater than the usage time.

[0081] 49) The method as described in 47), wherein the threshold is the number of hours per day less than the usage time.

[0082] 50) A system for monitoring negative pressure therapy, comprising:

[0083] Negative pressure therapy unit;

[0084] A dressing, which is fluidly connected to the negative pressure therapy unit;

[0085] A communication device, connected to the negative pressure therapy unit and configured to transmit operating data of the negative pressure therapy unit; and

[0086] A receiving unit configured to receive operating data transmitted from the communication device, wherein the receiving unit includes a processor configured to process the operating data to provide an output determination of whether the usage time of the negative pressure therapy unit meets a threshold.

[0087] 51) The system as described in 50), wherein the threshold is in the range of approximately 14 hours / day to 22 hours / day.

[0088] 52) The system as described in 51), wherein the threshold is approximately 16 hours / day.

[0089] 53) The system as described in 51), wherein the threshold is approximately 18 hours / day.

[0090] 54) Systems, apparatus and methods are substantially as described herein. Brief description of the attached diagram

[0091] Figure 1 This is a demonstration of a treatment network according to an exemplary embodiment;

[0092] Figure 2 It's a perspective view, showing what can be compared to... Figure 1 Additional details associated with some example embodiments of treatment units in the treatment network;

[0093] Figure 3 Screenshots of the graphical user interface (GUI) of the electronic display of the treatment unit are shown according to an exemplary embodiment;

[0094] Figure 4 Screenshots of a graphical user interface (GUI) for usage monitoring software running on an electronic device are shown according to an exemplary embodiment; and

[0095] Figure 5 This is a flowchart of an exemplary process for monitoring the use of a wound treatment system.

[0096] Detailed Description of Illustrative Examples

[0097] In the following detailed description of non-limiting, illustrative embodiments, reference is made to the accompanying drawings, which form a part of this detailed description. Other embodiments may be utilized, and logical, structural, mechanical, electrical, and chemical changes may be made without departing from the scope of the appended claims. To avoid details unnecessary for enabling those skilled in the art to practice the embodiments described herein, certain information known to those skilled in the art may be omitted. The following detailed description is non-limiting, and the scope of these illustrative embodiments is defined by the appended claims. As used herein, unless otherwise specified, "or" does not need to exclude each other.

[0098] These exemplary embodiments can also be described with reference to the spatial relationships between the different elements or to the spatial orientation of the different elements depicted in these figures. Generally, such relationships or orientations assume a frame of reference that is consistent with or relative to the patient to be treated. However, as those skilled in the art should recognize, this frame of reference is merely a descriptive provision and not a strict specification.

[0099] Figure 1 This specification provides schematic diagrams of example embodiments of a treatment network 100 for monitored wound treatment. The treatment network 100 may include a treatment system 102, which may include a treatment unit 104 and a dressing 106. The dressing 106 may include a cover 108 and a tissue interface 110. The dressing 106 may be fluidly connected to a negative pressure source 114, such as... Figure 1As shown, the treatment unit 104 may also include an exudate container, such as container 112, fluidly coupled to the dressing 106 and the negative pressure source 114.

[0100] 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 via wired or wireless means. The communication device 116 of the treatment system 102 may be configured to communicate with one or more networks 118 of the treatment network 100, and may include a transmitter. In a preferred embodiment, the communication device 116 may include a cellular modem and may be configured to communicate with the networks(s)118(s) via a cellular connection. In other embodiments, the communication device 116 may include… Wireless equipment Wireless equipment, or other radio technologies used for communicating with (multiple) networks 118 via a Personal Area Network (PAN) or Wide Area Network (WPAN). Communication device 116 can be configured to transmit data related to the operation of treatment system 102, which can occur in a patient's home or treatment center, such as a hospital or doctor's office.

[0101] In some embodiments, the communication device 116 may be integrated within the housing of the negative pressure source 114 of the treatment unit 104. In other embodiments, the communication device may be separately attached to the outer surface 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 attached to the outer surface of the negative pressure source 114 and may be connected to the negative pressure source 114 via a serial communication interface.

[0102] 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, and more specifically, the negative pressure source 114. Multiple processor algorithms may be programmed to calculate usage statistics based on the usage time and conditions of the negative pressure source 114. For example, the processor may calculate the total runtime of the negative pressure source 114 since a given patient began treatment, and calculate multiple average daily runtimes. The processor may be configured to calculate how the average daily runtime compares to prescribed treatment protocols and to calculate compliance with the corresponding prescribed treatment protocols. Additionally, the processor may be configured to generate warning signals based on compliance with prescribed treatment protocols, which may be communicated via a network (e.g., network 118) from a transmitter of the communication device 116.

[0103] The treatment network 100 may further include a remote monitoring center 120, which can communicate with the treatment system 102 via multiple networks 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 multiple networks 118. The remote monitoring center 120 may include an automated monitoring center 122. The automated monitoring center 122 may include a communication center 124 and an alert center 126. The communication center 124 may be designed to monitor the communication link between the treatment system (e.g., 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 related to the operation of the treatment system 102, and more specifically, treatment unit 104 and negative pressure source 114. The receiving unit may include a processing device loaded with software algorithms for processing the data related to the operation of the treatment system 102 and for providing output calculation results to calculate how the data related to the operation of the treatment system 102 compares to one or more thresholds. For example, in some embodiments, the threshold may correspond to a treatment protocol that specifies a minimum amount of treatment unit 104 to be used.

[0104] The warning center 126 of the automated monitoring center 122 can be configured to receive warning notifications from the treatment system (such as treatment system 102) and from the communication center 124. 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 also serves as a service center for compliance staff, clinicians, or other personnel monitoring patient use of the treatment system (such as treatment system 102), and sends escalable warning notifications from the warning center 126.

[0105] The treatment network 100 may also include other entities that can communicate with the treatment system and the remote monitoring center via networks(s)118. For example, the treatment network 100 may include a third party 130. For example, the third party 130 may be an insurance company. In one embodiment, the third party 130 may communicate with the remote monitoring center 120 via networks(s)118 to obtain usage data related to the treatment system 102. In other embodiments, the third party 130 may be able to receive usage data directly from the treatment system via networks(s)118 without needing to communicate with the treatment system.

[0106] Generally, the components of the treatment system 102 can be directly or indirectly connected, and in some cases can be detachably connected. For example, the negative pressure source 114 can be directly connected to the container 112 and indirectly connected to the dressing 106 via the container 112. The components can be fluidly connected to each other to provide a path for the transfer of fluids (i.e., liquids and / or gases) between these components.

[0107] In some embodiments, a component may be fluidly coupled, for example, to a pipe. As used herein, "pipe" broadly refers to a tube, conduit, hose, duct, or other structure having one or more lumens adapted for conveying fluid between two ends. Typically, a pipe is an elongated cylindrical structure with a degree of flexibility, but its geometry and rigidity can vary. In some embodiments, components may additionally or alternatively be coupled by physical proximity, integrated into a single structure, or formed from a single piece of material. In some cases, the coupling may also include mechanical, thermal, electrical, or chemical couplings (such as chemical bonds).

[0108] During operation, the tissue interface 110 may be placed within, above, over, or otherwise adjacent to the tissue site. A cover 108 may be placed above the tissue interface 110 and sealed to tissue near the tissue site. For example, the cover 108 may be sealed to undamaged epidermis surrounding the tissue site. Thus, the dressing 106 provides a sealed treatment environment adjacent to a tissue site substantially isolated from the external environment, and the negative pressure source 114 reduces pressure within the sealed treatment environment. The negative pressure applied to the tissue site within the sealed treatment environment through the tissue interface 110 induces macro- and micro-strains in the tissue site and removes exudates and other fluids from the tissue site, which can be collected in container 112 and appropriately treated.

[0109] The fluid dynamics of using a negative pressure source to reduce pressure in another component or location (such as within a sealed treatment environment) can be mathematically complex. However, the basic principles of fluid dynamics applicable to negative pressure therapy are generally well known to those skilled in the art.

[0110] Generally, exudates and other fluids flow along the fluid path toward lower pressure. Therefore, the term "downstream" typically refers to something relatively closer to a negative pressure source or further away from a positive pressure source in the fluid path; conversely, the term "upstream" refers to something relatively further away from a negative pressure source or closer to a positive pressure source. Similarly, certain characteristics of a fluid "inlet" or "outlet" can be conveniently described in such a frame of reference, and the process of reducing pressure can be illustratively described here as, for example, "delivery," "distribution," or "generation" of pressure reduction. This orientation is generally assumed for the purpose of describing the different features and components herein.

[0111] In this context, the term "tissue site" broadly refers to a wound or defect located on or within tissue, including but not limited to bone, adipose tissue, muscle tissue, nerve tissue, skin tissue, vascular tissue, connective tissue, cartilage, tendons, or ligaments. Wounds can include, for example, chronic, acute, traumatic, subacute, and laceration wounds; partial skin burns; ulcers (such as diabetic ulcers, pressure ulcers, or venous insufficiency ulcers); skin flaps; and grafts. The term "tissue site" can also refer to any area of ​​tissue that is not necessarily injured or defective, but rather to an area in which it may be desirable to increase or promote the growth of additional tissue. For example, negative pressure can be used in certain tissue areas to grow additional tissue that can be harvested and transplanted to another tissue location.

[0112] "Negative pressure" generally refers to pressure less than the local ambient pressure, such as the ambient pressure in the local environment outside the sealed treatment environment provided by dressing 106. In many cases, the local ambient pressure can also be atmospheric pressure at the patient's location. Alternatively, the pressure can be less than the hydrostatic pressure associated with the tissue at the site of treatment. Unless otherwise stated, all pressure values ​​stated herein are gauge pressures. Similarly, references to an increase in negative pressure typically refer to a decrease in absolute pressure, while a decrease in negative pressure typically refers to an increase in absolute pressure.

[0113] A negative pressure source, such as negative pressure source 114, can be an air reservoir under negative pressure, or a manually or electrically driven device that reduces pressure within a sealed volume, such as a vacuum pump, suction pump, wall suction port used in many healthcare facilities, or a micropump. The negative pressure source can 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. Although the amount and nature of the negative pressure applied to a tissue site varies depending on the treatment requirements, the pressure typically ranges from -5 mm Hg (-667 Pa) to -500 mm Hg (-66.7 kPa). Common treatment ranges are between -75 mm Hg (-9.9 kPa) and -300 mm Hg (-39.9 kPa).

[0114] The tissue interface 110 can be generally adapted to contact a tissue site. The tissue interface 110 can be in partial or complete contact with the tissue site. If the tissue site is, for example, a wound, the tissue interface 110 can partially or completely fill the wound, or it can be positioned above the wound. The tissue interface 110 can take many forms and can have various sizes, shapes, or thicknesses, depending on various factors such as the type of treatment being performed or the nature and size of the tissue site. For example, the size and shape of the tissue interface 110 can be adapted for the contours of deep and irregularly shaped tissue sites.

[0115] In some embodiments, the tissue interface 110 may be a manifold. In this case, a "manifold" generally includes any material or structure that provides multiple paths adapted to collect or distribute fluid throughout the tissue site. For example, a manifold may be adapted to receive negative pressure from a source and distribute negative pressure throughout the tissue site through multiple orifices, which can have the effect of collecting fluid from the entire tissue site and drawing fluid toward said source. However, in some embodiments, the manifold may also facilitate the delivery of fluid to the tissue site if, for example, the fluid paths are reversed or a second fluid path is provided.

[0116] In some illustrative embodiments, these pathways may be interconnected to improve the distribution or collection of fluids supplied to or removed from tissue sites. For example, honeycomb foams, open-cell foams, porous tissue aggregates, and other porous materials such as gauze or felt pads typically include structural elements arranged to form flow channels. Liquids, gels, and other foams may also include or be solidified to include multiple flow channels.

[0117] In some illustrative embodiments, the manifold may be a porous foam material with interconnected cells or pores adapted to distribute negative pressure throughout the tissue site. The foam material may be hydrophobic or hydrophilic. In a non-limiting example, the tissue interface 110 may be an open-cell mesh polyurethane foam, such as those available from Kinetic Concepts, Inc., San Antonio, Texas. Dressing.

[0118] In an example where the tissue interface 110 can be made of a hydrophilic material, the tissue interface 110 can also wick fluid away from the tissue site while continuing to distribute negative pressure to the tissue site. The wicking properties of the tissue interface 110 can draw fluid away from the tissue site through capillary flow or other wicking mechanisms. An example of a hydrophilic foam is a polyvinyl alcohol open-cell foam, such as those available from Dynamic Concepts, Inc., San Antonio, Texas. Dressings. Other hydrophilic foams may include those made of polyether. Other foams that may exhibit hydrophilic characteristics include hydrophobic foams that have been treated or coated to provide hydrophilicity.

[0119] When the pressure within the sealed treatment environment is reduced, the tissue interface 110 can further promote granulation tissue formation at the tissue site. For example, any or all surfaces of the tissue interface 110 may have an uneven, rough, or serrated profile, which can induce microstrain and stress at the tissue site if negative pressure is applied through the tissue interface 110.

[0120] In some embodiments, the tissue interface 110 may be composed of a bioresorbable material. Suitable bioresorbable materials may include, but are not limited to, polymeric blends of polylactic acid (PLA) and polyglycolic acid (PGA). The polymeric blends may also include, but are not limited to, polycarbonate, polyfuric acid ester, and caprolactone. The tissue interface 110 may further serve as a scaffold for new cell growth, or scaffold materials may be used in conjunction with the tissue interface 110 to promote cell growth. Scaffolds are generally a substance or structure used to enhance or promote cell growth or tissue formation, such as a three-dimensional porous structure that provides a template for cell growth. Illustrative examples of scaffold materials include calcium phosphate, collagen, PLA / PGA, coral hydroxyapatite, carbonates, or processed allogeneic transplant materials.

[0121] In some embodiments, the cover 108 can provide a bacterial barrier and protection against physical trauma. The cover 108 can also be made of a material that reduces evaporation loss and provides a fluid seal between two components or two environments, such as between a therapeutic environment and a local external environment. The cover 108 can be, for example, an impermeable or semi-permeable elastomeric material that provides a seal sufficient to maintain negative pressure at the tissue site for a given source of negative pressure. In some example embodiments, the cover 108 can be a water vapor-permeable but liquid-impermeable polymeric cover, such as a polyurethane film. Such covers typically have a thickness in the range of 25 to 50 micrometers. For permeable materials, the permeability should be generally low enough to maintain the desired negative pressure.

[0122] An attachment device can be used to attach the cover 108 to an attachment surface, such as an undamaged epidermis, liner, or another cover. The attachment device can take many forms. For example, the attachment device can be a medically acceptable pressure-sensitive adhesive that extends around the periphery of the sealing member, a portion of the sealing member, or the entire cover 108. In some embodiments, for example, some or all of the cover 108 can be coated with an acrylic adhesive having a coating weight between 25 and 65 grams per square meter (gsm). In some embodiments, a thicker adhesive or combination of adhesives can be applied to improve sealing and reduce leakage. Other exemplary embodiments of the attachment device may include double-sided tape, paste, hydrocolloid, hydrogel, silicone gel, or organic gel.

[0123] Container 112 represents a container, canister, bag, or other storage component that can be used to manage exudates and other fluids aspirated from tissue sites. In many environments, rigid containers may be preferred or necessary for the collection, storage, and treatment of fluids. In other environments, fluids can be properly treated without the need for rigid container storage, and a reusable container can reduce waste and costs associated with negative pressure therapy.

[0124] Reference Figure 2 The illustration depicted according to one embodiment is an illustrative example of treatment unit 204, and may be another embodiment of treatment unit 104. Treatment unit 204 is suitable for use as a component of treatment system 102. Treatment unit 204 may include housing 205, which may enclose negative pressure source 214 and communication device 216. Treatment unit may also include electronic display 217 for connection to a user interface. Container 212 may be configured for attachment to housing 205 of treatment unit 204.

[0125] Reference Figure 3An example embodiment of the electronic display 217 of the treatment unit 204 is shown. The electronic display 217 can be configured to display a graphical user interface (GUI) 300. The GUI 300 may include a number of selectable graphical 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 a plurality of soft buttons designated for any other features related to treatment of the tissue site. The user can select any of these functions (i.e., settings, wound type, treatment protocol, usage data, communication) so that the electronic display 217 presents the user with another graphical 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 other and / or alternative functions and selection elements may be provided to the user.

[0126] Information area 316 on GUI 300 may include selectable graphical elements and display other information that the user may be interested in. For example, a "Help" soft button 318 may be displayed to provide the user with assistance regarding treatment unit 204 or the specific functions currently displayed on GUI 300. A "Transmit" soft button 320 allows the user to selectively activate or deactivate communication device 216 of treatment system 102 to start or stop the transmission of usage data to network(s)118. A "Switch" soft button 322 allows the user to selectively turn treatment unit 204 on and off. Information status area 324 may inform the user of the current status of treatment unit 204. For example, information status area 324 may indicate that treatment unit 204 is: (i) currently on, (ii) operating according to a specially selected treatment protocol, and (iii) transmitting operating data to a remote receiver. Information status area 324 may also indicate whether communication device 216 is: (i) currently activated, (ii) currently deactivated, (iii) currently transmitting data, and (iv) currently receiving data. The information status area 324 can also provide visual indications of the patient's use of the treatment system 102 and the degree of compliance with prescribed treatment protocols.

[0127] In some embodiments, the treatment system 102 may be configured to display usage compliance information to a user on an information status area 324, or to notify caregivers or other service providers that the user (e.g., a patient) is complying with prescribed treatment protocols. For example, usage compliance information may include information or data about whether negative pressure therapy is applied to the tissue site over time. Usage compliance information may also include information or data about 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 about whether the treatment system 102 is being used in accordance with prescribed treatment protocols (e.g., protocols that limit different pressures and / or flow rates over time). Compliance analysis may also include information or data about the progress of wound healing over time. Additional compliance output information may include output data and information, such as providing audible or visual warnings when non-compliance reaches an unacceptable level or threshold. This output compliance information may also provide feedback to the user (e.g., the patient) before providing this information to others (e.g., a clinician), thereby giving the user the opportunity and incentive to correct non-compliance before it reaches an unacceptable level or threshold. Additional compliance input information may include input data and information, such as information about the settings of the treatment system 102 or information entered by the caregiver. Such compliance input information may include, for example, treatment pressure settings, maximum and minimum target pressures, flow rate settings, the intensity and / or duration of any supplemental treatments (such as fluid perfusion), and data indicating whether negative pressure therapy is applied in a continuous or intermittent operating mode.

[0128] Information status area 324 can also be configured to display messages communicated to the user from a remote location. For example, a clinician at a remote monitoring center 120 may send messages to treatment system 102 via network(s)118 for display to the patient. Such messages may include instructions to keep treatment system 102 powered on and available. Additionally, such messages may include instructions to troubleshoot one or more problems present in treatment system 102. Troubleshooting instructions may include instructions to empty or change the exudate container or to recharge or replace the battery of treatment system 102.

[0129] Figure 4Screenshots of an illustrative GUI 400, or another embodiment of GUI 300, or a portion thereof, for exemplary embodiments of usage monitoring software on an electronic device (such as a computer with an electronic display), are shown. The electronic display may be electronic display 217 including GUI 300. This exemplary embodiment of GUI 400 provides a patient profile view 402, including 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 regarding a patient's treatment system (such as treatment system 102). The patient profile view 402 may display data information based on device log data from the treatment system. This device log data is interpreted and manipulated by the usage monitoring software prepared for display. The usage monitoring software may parse the date-stamped and times-stamped data to calculate potential non-compliant usage statistics.

[0130] The report display 404 may include a daily usage summary 410, which can display to the user the total amount of time the treatment system has been running each day. The report display 404 may also include a healing measurement results display 412. The healing measurement results display 412 can provide data for tracking the healing progress of one or more wounds on a patient. For example, the healing measurement results 412 may display data corresponding to the percentage of healing already experienced by a particular wound. Alternatively, the healing measurement results display 412 may display data on physical measurements of one or more wounds, such as length, width, depth, circumference, and others.

[0131] The compliance analysis display 406 can display data and analysis related to a patient's use of a treatment system (such as treatment system 102), and the degree of compliance of this use with one or more treatment protocols. For example, a compliance chart 414 can show a comparison of the amount of time a patient uses the treatment system each day relative to the amount of time specified according to the treatment protocol. The compliance analysis display 406 may also include a healing analysis chart 416, which can compare the healing rate of one or more wounds of a patient with the average healing time of (multiple) similar wounds. Alternatively, the compliance analysis display 406 can display analysis related to (multiple) specific time frames within a day or night of treatment system use. The compliance analysis display 406 may also, or alternatively, display statistics related to any other aspect of the patient's use of the treatment system or the healing of one or more wounds.

[0132] The warning management display 408 can display information about different types of warnings or alarms associated with the use of the treatment system (such as treatment system 102). For example, the warning management display 408 may include a warning window 418 and a communication window 420. The warning window 418 may include one or more indicators related to different features or functions of the treatment system. For example, the warning window 418 may include a leak direction indicator 422, which can signal to the user that a fluid leak has been detected on the patient's treatment system. The warning window 418 may also include a blockage direction indicator 424, which can warn the user that a fluid blockage has been detected in the treatment system. A container full indicator 426 may also be included, indicating that a container used to collect wound exudate is full or nearly full. Additionally, a low battery indicator 428 may be included to signal that one or more batteries in the treatment system are approximately depleted. Furthermore, the warning management display 408 can allow for remote troubleshooting of problems with the treatment system 102.

[0133] The communication window 420 of the warning management display 408 can display warnings to the user regarding the connection status with one or more treatment systems and provides a user interface for browsing and changing settings related to communication with the treatment systems(s). For example, the communication window 420 may include an uplink failure indicator 430, which can signal to the user that the communication link with the monitored treatment system has been interrupted. It may also include a configuration button 432 for allowing the user to access a menu for configuring communication and / or network settings to establish and maintain remote monitoring capabilities of the treatment systems.

[0134] Although Figure 4 While the illustrative GUI 400 focuses on individual patient data, other illustrative GUIs may include reports focusing on profile data for a broad patient base. For example, an overview of a given patient population could be provided, which could offer efficient identification of patient outliers that may require remediation. Such overviews could include browsing patient data at a macro level, such as by grouping patient data according to patient demographics, payment groups, wound type, or comorbidities. Providing a profile view of one or more patient populations can allow for better insights into patient care on a broader scale.

[0135] In a typical home care setting, patients undergoing wound treatment are visited every 2 to 3 days for dressing changes. During this time, clinicians can assess patient compliance with prescribed treatment protocols. Clinicians can use the GUI 404 of the treatment system 102 and its features described above, and / or additionally visually examine tissue sites to make this assessment. However, visiting patients every 2 to 3 days is not the optimal time to determine whether a patient is consistently using the negative pressure therapy system as prescribed (e.g., within the recommended daily treatment hours). In many cases, providers and insurers expect patients to use the negative pressure therapy system 24 hours a day; however, actual usage by some patients may be lower. Since there is no way to collect this usage data, the extent of compliance issues is largely unknown. Non-compliance below certain thresholds is now understood to affect patient healing.

[0136] As disclosed herein, Treatment Network 100 improves the management of negative pressure wound therapy. For example, by providing a system for remotely monitoring the compliance of negative pressure therapy system use, non-compliant use can be detected more quickly, allowing caregivers and patients to be advised more rapidly to use the treatment system as prescribed. As a result, improved adherence to treatment protocols can be achieved, and faster tissue healing can be achieved. For example, clinical nursing teams or home healthcare providers can be able to contact the monitored patient to provide instructions to become compliant with given prescribed treatment.

[0137] At runtime, it can be based on Figure 5 An exemplary embodiment of the monitoring method 500 shown herein utilizes a treatment network 100 and its various components and features. For example, operation of the treatment network 100 may begin with the activation of a treatment system (e.g., treatment system 102). A dressing (e.g., dressing 106 of treatment system 102) may be applied to a tissue site, as shown in step 502. Negative pressure may then be applied to the dressing and tissue site by fluidly connecting a negative pressure source (e.g., negative pressure source 114) to the dressing and then activating the negative pressure source, as shown in step 504. Step 506 provides the following process: activating the communication capabilities of the treatment system and establishing communication with one or more remote monitoring centers to begin data transmission (e.g., data usage).

[0138] Once the treatment system has begun transmitting data, the usage data can be received and analyzed at a remote location (such as a remote monitoring center), as indicated in step 508. Users at the remote location (such as clinicians or compliance team members) can review the usage data transmitted from the treatment system related to a specific patient using a GUI. In some cases, the GUI can be viewed on a computing device (such as a desktop terminal). In other cases, the GUI can be viewed using a proprietary software application on a personal wireless device (such as a smartphone).

[0139] In some preferred embodiments, this usage data and (specifically) usage compliance information may include when a treatment unit (e.g., treatment unit 204) is turned on or off. In other embodiments, this usage compliance information may further include whether a communication device (e.g., communication device 216) is activated or deactivated within a given time period, and / or, when activated, whether communication device 216 is transmitting data to a remote receiver. Additionally, the received usage compliance information may be analyzed to determine whether it conforms to the expected usage data to be transmitted.

[0140] When reviewing this compliance information, the user can determine whether the patient's use of the treatment system complies with one or more prescribed protocols, as shown in step 510. In some embodiments, automated monitoring capabilities can be employed, and this compliance determination can be performed automatically. If the compliance assessment determines that the patient's treatment system is being used in accordance with the given prescribed protocols, step 508 can be repeated according to a routine monitoring plan. 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 protocols, a warning can be signaled at a remote monitoring center, as shown in step 512.

[0141] For example, if a patient prescribed 24-hour negative pressure wound therapy (NPWT) only uses the system for approximately 14 hours per day, a remote monitoring center can detect this discrepancy between the prescribed and actual treatment. In some preferred embodiments, threshold warnings can be set to address when compliance with NPWT use depends on other treatment factors and wound conditions falling below a certain amount of time between 16 and 20 hours per day. For instance, if the compliance team determines that the current treatment is generating a large volume of wound exudate (potentially hindering the healing process), the input compliance threshold can be set to 18 hours per day. In another example, the input compliance threshold could be set to 16 hours per day to accommodate the management of fluid perfusion therapy. In any embodiment, the warning threshold limit can be adjusted to account for other factors that may affect the management of NPWT.

[0142] While it is often preferred to administer negative pressure wound therapy (NPWT) to patients as close to 24 hours / day as possible, compliance thresholds (such as those discussed above) can be established based on empirical data indicating the critical impact of usage time on wound healing progress. Wound healing progress can be measured by the percentage reduction in wound volume per day (i.e., wound volume reduction). Studies generating empirical data have shown that the percentage of NPWT administered over a 24-hour period (i.e., usage percentage) can enhance wound volume reduction. Furthermore, significant differences in wound volume reduction exist between certain usage percentage values, indicating which usage percentage values ​​or ranges represent target thresholds for compliance.

[0143] As can be seen from the data in Table 1, there may be a critical threshold between the 60-69% usage percentage range (approximately 14.5 to 16.5 hours per day) and the 70-79% usage percentage range (approximately 17 to 19 hours per day). Therefore, based on this data, in order to achieve a greater than approximately 1.5% reduction in wound volume per day, users should adhere to at least approximately 70% (or approximately 17 hours per day) of negative pressure therapy compliance threshold to avoid non-compliance warning alerts.

[0144] Table 1

[0145]

[0146] In addition to signaling warnings at the remote monitoring center, automated user messages can 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 can be automatically displayed on the treatment system's GUI. In some embodiments, a sound or other form of warning can accompany the message display to attract the user's attention. In other embodiments, user messages can be sent to the user via a network by the remote monitoring center using other means. Some examples of other messaging forms of communication may include sending text messages to a specific user's registered phone number. Similarly, emails can be sent to a user's archived address. In another embodiment, automated telephone messages can be delivered to a user's registered phone number.

[0147] After this message is delivered to the user, usage monitoring can continue, as shown in step 516, specifically to detect signs of improved compliance with the treatment protocol. Step 518 demonstrates that usage data can be analyzed again, similar to the type of data analysis performed in step 510, to determine whether the patient has improved their compliance with a given treatment protocol when using the treatment system, such as meeting a specified usage threshold, such as 20 hours / day. In some cases, the determination of whether the specified usage threshold is met or exceeded can be assessed daily or as an average over a multi-day period. For example, the daily percentage reduction in wound volume shown in Table 1 can be determined by averaging the percentage reduction in wound volume over several days. Furthermore, the specified usage threshold can change over time, such as increasing or decreasing from one week to the next. For example, the threshold can be decreased when significant healing progress has been shown at a specific tissue site. However, on the other hand, the specified usage threshold can be increased over a period of time when healing progress is slower than expected (possibly due to non-compliance with the given treatment protocol).

[0148] In one embodiment, a warning is generated if daily usage falls below 14 hours. In another embodiment, a warning is generated if daily usage falls below 16 or 18 hours, or if daily usage falls between 14 and 22 hours. Alternatively or additionally, a warning may be generated if average usage over a multi-day period falls below 14, 16, or 18 hours, or if average usage falls between 14 and 22 hours. For example, if usage falls below an average of 15 hours over a three-day period, or if usage falls below an average of 17 hours over a three-day period.

[0149] The threshold used to generate warnings can be adjusted over time. In one embodiment, the threshold is set within a first, higher range, such as 18 to 22 hours. Subsequently, the threshold can be set within a lower range, such as 14 to 16 hours. Alternatively, the threshold can be adjusted based on signals received from the user or caregiver. For example, if the system receives signals indicating a higher-risk patient, such as a patient starting treatment for the first time, a patient with an infected wound, or a patient with one or more comorbidities, the system will utilize a higher usage threshold. The system can set lower usage thresholds when it receives different signals from the user or patient. Low-risk patient signals can be received for compliant patients, patients with healing or fully healed wounds, or patients frequently visited by caregivers.

[0150] For example, if a signal indicating improved compliance is received, or the system determines that compliance has improved, routine monitoring of the treatment system's use can be resumed, 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 can be alerted, as shown in step 520. For example, in some embodiments, the alert can be triggered in an alert center 126 of automated monitoring center 122 and then communicated to a compliance team center 128 of remote monitoring center 120. Upon reviewing the alert, the clinician or other compliance team member can contact the patient, as shown in step 522, to work towards improving compliance with the treatment protocol. Furthermore, patients monitored by or assigned to a given clinician can be prioritized based on the severity of non-compliance.

[0151] As used herein, usage refers to the time the medical device is turned on. Alternatively, usage may refer to the time during which treatment is delivered. On the other hand, usage can be measured by the time the device delivers the target treatment. For example, the system can indicate usage by receiving signals from sensors indicating that the device has been turned on or off, or that the pump has been turned on or off. The medical device can store data about usage and then send signals to the system indicating usage over time periods of hour, day, or multiple days.

[0152] Following this contact with the clinician or other compliance team member, compliance use monitoring can continue as shown in step 524. Similarly, step 526 shows that usage data can continue to be analyzed, similar to the type of data analysis performed in steps 510 and 518. Again, if it is determined that compliance needs to be improved, routine monitoring of the use of the treatment system can be resumed according to step 508. If compliance with prescribed treatment protocols does not improve, as shown in step 528, warnings about non-compliance can be escalated within the compliance monitoring team, allowing for further action to improve patient care.

[0153] The systems and methods described herein offer significant advantages, some of which have already been mentioned. For example, current methods of monitoring patient compliance require patients to personally review device event logs at the patient's side. Manual calculations and analysis are needed to determine the amount of time spent in non-compliance. In some cases, clinicians can spend up to ten minutes performing calculations and analysis to determine two to three days of device usage, which is impractical in the contemporary healthcare environment. As a solution, teletherapy networks, as described above, provide rapid access to patient compliance information from wherever the internet is available (desktop computers, smartphones, tablets, etc.). Therapy network 100 can provide analysis of the data output to provide caregivers with information in a meaningful format. No calculations are necessary, and clinicians can be alerted to provide feedback to patients to improve compliance where necessary. Based on the data studied, it is expected that this invention will improve wound care in standard stand-alone negative pressure wound therapy.

[0154] Treatment Network 100 can provide improved patient monitoring. For example, device log data can be viewed remotely by many 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 healing time at tissue sites and reduced overall treatment costs.

[0155] While certain illustrative and non-limiting exemplary embodiments have been presented, various changes, substitutions, arrangements, and alterations may be made without departing from the scope of the appended claims. Any feature described in connection with any exemplary embodiment may also be applied to any other exemplary embodiment.

[0156] Furthermore, the steps described herein can be performed in any suitable order, or simultaneously where appropriate.

Claims

1. A system for monitoring negative pressure therapy to a tissue site, comprising: a negative pressure source; a dressing fluidly coupled to the negative pressure source and adapted for placement at the tissue site for the distribution of negative pressure; and a communication device operably coupled to the negative pressure source and configured to transmit operational data of the negative pressure source, the communication device comprising: a receiver configured to receive operational data from the negative pressure source, a processor configured to process the operational data to provide an output determination indicating whether a usage time of the negative pressure source meets a threshold value within a first range, the processor further configured to update the first range to a second range based on a desired wound volume reduction, and a transmitter configured to transmit the operational data to a remote receiver for indicating a degree of compliance to a prescribed protocol; wherein, in response to receiving operational data indicating that the usage time of the negative pressure source is less than the threshold value, the remote receiver is configured to initiate: an automated user message to the communication device, a text message to a recorded phone number of a user of the negative pressure source, an email to an email address associated with the user, or a phone message to the phone number. the negative pressure source is encased in a negative pressure therapy unit.

2. The system of claim 1, wherein, the communication device is encased in a negative pressure therapy unit.

3. The system of claim 1, wherein, 4. The system of claim 2, further comprising a container fluidly coupled to the negative pressure source and configured to collect fluid from the dressing. the container is coupled to the negative pressure therapy unit.

5. The system of claim 4, wherein, the dressing comprises:

6. The system of claim 1, wherein, a tissue interface adapted for placement proximate the tissue site; and a cover adapted for placement over the tissue interface. the processor is configured to process the operational data to calculate one or more usage statistics.

7. The system of claim 1, wherein, the transmitter is configured to transmit the one or more usage statistics to the remote receiver for providing a warning signal.

8. The system of claim 7, wherein, the phone message comprises an automated text message.

9. The system of claim 1, wherein, the phone message comprises a phone call.

10. The system of claim 1, wherein, the phone message comprises a text message.

11. The system of claim 1, wherein, the threshold value is a predetermined hourly value in a range of 16 hours / day to 19 hours / day.

12. The system of claim 1, wherein, ​

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