Systems, methods and garments for monitoring and controlling fluid pressure during compression therapy - Patents.com

Abstract

A compression system (100) for monitoring and controlling fluid pressure during compression therapy. The compression system comprises at least one inflatable or deflatable compression garment (120), an air pump (110) for regulating air pressure to the compression garment when connected to the air pump, an indicator unit (117) and a controller operatively connected to the air pump (110) for monitoring usage of the at least one compression garment (120), wherein the indicator unit (117) includes first display indicators (117a, 117c) associated with a monitored usage time of the at least one compression garment (120) in a first operating state of the compression system (100) when the compression garment (120) is applying compression to a patient and second display indicators (117b, 117d) associated with a monitored usage time of the compression garment in a second operating state of the compression system (100) when the compression garment is not applying compression to the patient, and wherein the indicator unit (117) is configured to automatically switch between the first and second display indicators associated with the operating states of the compression system (100).

Description

[Technical field]

[0001] The present invention relates to a compression system, method and garment for monitoring and controlling fluid pressure during compression therapy applied to a patient's limb or other anatomical structure. The present invention relates to medical compression systems, and in particular to pneumatic systems having an inflatable / deflateable article connected to a fluid source, such as a pump. Examples of uses for such compression systems include preventing venous thromboembolism (VTE) or providing treatment for other cardiovascular diseases including edema, ischemia and venous insufficiency. The present invention further relates to an indication of the duration of use of the compression system and connected compression garment. [Background technology]

[0002] Medical compression systems, particularly pneumatic systems, include an inflatable / deflatable article connected to a fluid source, such as a pump. Examples of uses for such compression systems include preventing venous thromboembolism (VTE) and providing treatment for other cardiovascular disorders including edema, ischemia, and venous insufficiency.

[0003] These systems typically consist of a pump or controller that acts as a fluid source and at least one patient-worn article or garment intended to apply compression to an anatomical region of the patient, such as an individual limb or portion thereof, such as the foot, calf, thigh, hand or arm.

[0004] Such systems are well known to have a coupling assembly that connects an article or garment to a fluid source, the coupling assembly comprising a first male insert connector and a cooperating second female receptacle for receiving the first male insert to form a mated condition. The male insert member and the female receptacle together define a path for fluid to flow through the garment when in a mated condition. The garment can be fitted with either a male or female connector. The garment connector is fitted with an identification component that can be measured, detected or read by the pump connector.

[0005] Garment connectors known in the prior art (e.g., US 7,398,803 to Newton) include an identification component that can be automatically detected by a compression pump when connected. The use of this component, and related approaches for automatically configuring a compression pump through the setting of preventative parameters, are also well established in the prior art (e.g., US 6,884,255 to Newton). Summary of the Invention

[0006] The present disclosure relates to systems, methods and garments for monitoring and controlling compression therapy on a patient's limbs or anatomical structures. With the above discussion in mind, it is an aspect of some embodiments of the present invention to increase monitoring and indication to the user regarding the extent of system usage, as well as to allow for proactive promotion to ensure increased preventative usage. The present invention seeks to mitigate, alleviate or eliminate one or more of the above-mentioned disadvantages in the prior art.

[0007] One aspect of the invention relates to a compression system provided for monitoring and controlling fluid pressure during compression therapy. The system includes at least one inflatable or deflatable compression garment, an air pump for regulating air pressure to the compression garment when connected to the air pump, an indicator unit, and a controller operatively connected to the air pump for monitoring usage of the at least one compression garment. The indicator unit includes a first display indicator associated with a monitored usage time of the at least one compression garment in a first operating state of the compression system when the compression garment is applying compression to a patient, and a second display indicator associated with a monitored usage time of the garment in a second operating state of the compression system when the compression garment is not applying compression to a patient. The indicator unit is configured to automatically switch between the first and second display indicators associated with the operating states of the compression system 1.

[0008] One aspect of the invention relates to a compression garment provided for attachment to a limb or part thereof of a human body, the duration of connected time being monitored by a system for monitoring and controlling fluid pressure during compression therapy, and the time in a first operating state being totalled and displayed on a user interface of an air pump of the compression system.

[0009] One aspect of the invention relates to a compression system provided for monitoring and controlling fluid pressure during compression therapy. The system includes at least one compression garment, an air source for regulating air pressure to the at least one compression garment when connected to the air source, a controller operatively connected to the air source and configured to monitor usage of the at least one compression garment, and a limb detection unit. The at least one compression garment includes a connection unit having an identification component, the identification component being made of ferrite, steel or brass. The limb detection unit is configured by the compression system based on the nature of the identification component of the compression garment.

[0010] One aspect of the invention provides a method for monitoring and controlling fluid pressure during compression therapy in a compression system, the system comprising a pump, at least one inflatable or deflatable compression garment, an indicator unit, and a control unit for monitoring usage of the at least one compression garment. The indicator unit comprises a first display indicator associated with a monitored usage time of the at least one compression garment in a first operational state of the compression system when the compression garment is applying compression to a patient, and a second display indicator associated with a monitored usage time of the garment in a second operational state of the compression system when the compression garment is not applying compression to the patient. The method includes activating the compression system, identifying a connected compression garment, initiating a preventive operation, detecting and displaying usage of the at least one compression garment of the compression system, and automatically switching between the first and second display indicators associated with the operational state of the compression system.

[0011] The features of the detailed embodiments and aspects may be combined in any combination. [Brief description of the drawings]

[0012] Further objects, features and advantages of the present invention will become apparent from the following detailed description of the invention in which the embodiments of the present invention are described in more detail with reference to the accompanying drawings. [Figure 1] FIG. 1 illustrates a compression system for fluid pressure control according to one embodiment of the present invention. [Diagram 2] FIG. 2 shows a control system diagram of a compression system according to one embodiment of the present invention. [Diagram 3] 3a to 3d show various embodiments of an indicator unit according to an embodiment of the present invention. [Figure 4] FIG. 4 illustrates a timing diagram of use and non-use of a compression system according to one embodiment of the present invention having functional aspects thereof. [Diagram 5] FIG. 5 illustrates a flow chart of one embodiment of a method for controlling fluid pressure in a compression system according to the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] Hereinafter, embodiments of the present invention will be described in more detail with reference to the accompanying drawings, in which embodiments of the present invention are shown. However, the present invention may be embodied in many different forms and should not be construed as being limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the present invention to those skilled in the art. Like reference characters refer to like elements throughout.

[0014] The present invention relates to medical compression systems, and in particular to pneumatic systems having an inflatable / deflatable garment connected to a fluid source, such as a pump. Examples of uses for such compression systems include preventing venous thromboembolism (VTE) or providing treatment for other cardiovascular disorders including edema, ischemia, and venous insufficiency.

[0015] The present invention further extends the use of the identification component to allow for the setting and selection of parameters relating to timing the connection of the garment to the pump and accurate means of detection of the patient's extremities within the garment.

[0016] The use of different identification component types, features, sizes and locations for each type of garment allows for the identification and selection of multiple parameters by the compression system that can provide useful information to the compression system, including a means for identifying the specific garment type, connected garment model or size, number of garments attached to the pump, and which specific sensing technique and parameter from among multiple possible parameters should be used to identify the presence of a patient's extremity within a specific connected garment. This approach allows for the selection of an optimal technique from multiple techniques to employ for detecting when a patient's extremity is within or enveloped by the compression garment.

[0017] A further aspect of the invention involves using the continuous and temporal presence of a particular identification component to monitor engagement of the connector, thereby measuring how long the connection has been successful, such that the pump can detect, measure and record the delivery of compression therapy through the connector to the garment and the limb therein.

[0018] The combination of confirmation of fluid connection of the garment and confirmation of use of the system by the patient's limb forms a total time value displayed to form a first display state on the user interface, thereby accurately measuring the duration of treatment / prophylaxis delivered to the patient and creating clinically usable information.

[0019] A further aspect includes timing the amount of time the garment connector is disconnected during intended use of the compression system, with the time value forming a second display state displayed on the user interface. This is particularly beneficial as it indicates to the clinician a lack of precautions by garment removal that could have very dangerous clinical consequences.

[0020] A further aspect of the present invention includes detection of cases where the garment is physically connected to the pump controller and receiving stimulation via a valid fluid connection, but the garment has actually been removed from the patient's limb or anatomy and is not providing the intended clinical effect.

[0021] This monitoring can employ a variety of sensing technologies, algorithms and calculations that can vary for each individual garment type and size, and an identification component present in the garment connector can be used to select the appropriate monitoring configuration.

[0022] This embodiment further includes combining both detection of the identification component to confirm fluid connection and use of the identification component to constitute a sensing means used to identify the presence, removal, re-donning, or lack of presence of the garment on the patient's anatomy. This detection is further timed to form part of an alternative second display state of the user interface. This situation may occur, for example, when a patient, caregiver, or clinician removes a compression garment and forgets to replace it, resulting in a similarly clinically dangerous situation for the patient. It is particularly beneficial for the clinician to be able to accurately and easily see the time that prophylaxis has not been applied so that appropriate clinical action can be taken. The second display state of the user interface can be formed from minutes, hours, or a combination of both.

[0023] Therefore, by integrating the above-described monitoring and identification process with the basic operation of the compression system, a more beneficial and effective compression solution is provided.

[0024] The above integration in the present invention also avoids the difficulties experienced when utilizing alternative clothing identification approaches that use only pressure-based sensing methods. Pressure measurement techniques can have variability due to many factors, such as how the garment is fitted, how tight it is around the limb, its size, and differences in limb size. These variability can affect the accuracy of the clothing identification detection method or the identification of the limb within the garment.

[0025] The present invention involves monitoring product usage in a clinical setting, which is based on the combination of the following individual aspects: - Time-based monitoring and recording of the total duration of pumping in the selected garment or garments, including recording the duration of pumping when the required number of limbs are identified as being present in the connected garment during garment inflation, in the form of a number of records in the form of start / stop time-based data records and incrementing elapsed time counters, providing a set of records having a time basis, which in combination with at least one of the key elements described below, allows the system to determine when, for how long and how effectively prophylaxis was or was not administered. - Displaying to the user (via user interfaces such as the pump LCD and external LED indicators) the overall elapsed time that prophylaxis has been successfully delivered to the patient's anatomy located within the connected garment while the pump is in operation. This elapsed time is accumulated over individual prophylaxis episodes and can be reset / cleared for a new patient, or at the start of each shift or day, or as needed. The reset process can be done automatically after a predefined period of inactivity or by manual intervention by the user via the interface. - Displaying to the user (via user interfaces such as the pump LCD and external LED indicators) the overall elapsed time during pump actuation during which prophylaxis has not been successfully delivered to the patient, either due to the absence of a sensed anatomical structure in the connected garment or because the garment is not connected, this time being shown as the current duration during which prophylaxis has not been delivered. -Any of the durations described above are visibly displayed on the user interface during normal controller / pump operation and do not require operator action to access the information via subsequent screens or menus. This immediately visible display allows the clinician / caregiver to see the usage information at a glance as they pass by the pump without requiring action, thereby reducing the clinician's workload in monitoring compression system usage.

[0026] It is known that many products, including compression pumps, incorporate simple timers related to usage history, such as, for example, simple elapsed time since a previous compression was initiated. A novel aspect of the present invention is the automatic change of display information between a first display state having accumulated usage data including previously delivered prophylactic timing information, and a second display state having current non-use timing information. The second display state specifically indicates the elapsed time associated with under-delivery to the patient when the compression system is active, which is presented in the form of a count-up time value initially shown in minutes. This display of time is also associated with a visual indicator using an LCD icon or LED indicator, or other user feedback means such as an optional audible announcement.

[0027] A specific embodiment of the invention includes flashing a leg graphic icon on the LCD to clearly highlight that a particular pump output garment is not providing protection to the limb (the issue is related to the absence of a limb within the garment, rather than a malfunction in the garment or pump operation). In one embodiment of the invention, protection continues to be applied to the garment even when the absence of a limb or anatomical structure is detected, thereby ensuring continued beneficial operation despite a detection failure.

[0028] A further aspect of the invention includes the user display automatically switching from the second display mode to the first display mode when the anatomical structure is sensed to have returned to the garment.

[0029] In a further aspect of the invention, the elapsed use timer is not specifically incremented when no anatomical structures are sensed as being present in association with the at least one garment.

[0030] It may incorporate one or more of the following elements: -The incorporation of a real-time clock (RTC) device into the compression system can provide useful details such as the actual date and time of system use. The daily care of the patient can affect or prevent use of the compression system (e.g. bathing / toileting / examination / diagnostic procedures / medication, etc.) and this time is often scheduled or otherwise known and therefore recorded in the patient's care record. The use of this system, including accurate timing of the start and stop of delivered prophylaxis, can improve nursing management, audit processes and clinical reporting of the effectiveness of VTE prophylaxis administered to patients. -The use of start / stop timestamp-based measurement techniques also enables the RTC to store time-stamped records in the controller memory in the form of a log of individual events of use and non-use events and durations. This includes times associated with clinician actions resulting in the pump not being used, such as removing clothing from the pump and physically powering the pump off. Thus, individual patient episodes of use are identified and recorded for later analysis and reporting to clinicians, as well as for inclusion in the patient's electronic medical record (EMR).

[0031] In one aspect of the invention, rather than simply recording the duration of an episode, both the start and stop timestamps are used. From this baseline data, it is possible to build a detailed and relevant time log of system usage and precautions taken.

[0032] Instead of a simple compliance timer as is well known in the prior art, a usage monitor and timer, based on detection of limb presence, identifies usage episodes from which prevention is provided. The timer attempts to identify individual compression periods and durations of use and non-use rather than relying on simple summation of time over a period of time. This approach provides a more useful clinical data function than compliance monitoring based on simple overall total time.

[0033] In an embodiment where the pump displays the time since the patient removed the garment from the limb, or the time since the garment and pump connector were unplugged, both of which can be done without accessing the pump controls. It is such patient-initiated erroneous behavior that the present invention monitors, and which is believed to be the primary cause of insufficient prophylaxis time. A practical example of such a situation would be when a patient removes the garment from the limb to go to the toilet, but does not re-apply the garment to the limb when they return.

[0034] In such an event, the compression system would switch from the first indicating state to a second indicating state to display the time since detachment occurred. This aspect allows a clinician to easily identify lack of use / adherence to prescribed care and make a clinical decision regarding safe and appropriate intervention for the patient.

[0035] 1 shows the general configuration of a compression system 100 for monitoring and controlling fluid pressure during compression therapy. In one embodiment, system 100 is a gas pressure compression system, such as a pneumatic compression system, or any type of fluid based suitable for application with an inflatable / non-inflatable article or garment 120.

[0036] System 100 comprises at least one inflatable / deflate garment 120 in the form of a compression garment, an air source 110, i.e., an air pump, and a controller 210 (not shown in FIG. 1 ) operably connected to pump 110. Controller 210 is operably connected to pump 110 for controlling pump 110. Pump 110 may be a pneumatic pump.

[0037] In one embodiment, the pump 110 is configured to control the flow of fluid to and from the inflatable / contractible garment 120. That is, the pump 110 is configured to inflate or deflate the inflatable / contractible article 120.

[0038] The system 100 further comprises a coupling assembly 300 for fluidly connecting the inflatable / deflatable garment 120 and the pump 110. The coupling assembly 300 includes a connector 330 and a connecting member 310.

[0039] The connector 330 is connectable to the connecting member 310 such that, upon engagement, a fluid passageway is formed through the connector 330 and the connecting member 310. That is, the connector 330 is connectable to the connecting member 310, thereby allowing fluid communication through the coupling assembly 300.

[0040] Coupling assembly 300 includes an identification component 390. The location, size and type of identification component 390 is provided on connector 330 or connecting member 310, and a sensing device (not shown in FIG. 1 ) is provided for sensing the position of the identification component 390 relative to the sensing device during engagement between connector 330 and connecting member 310.

[0041] Thus, misconnection or partial engagement between the connecting member 310 and the connector 330 can be detected by detecting the presence and monitoring the position of the identification component 390. Thus, through this monitoring and indication, the risk and impact of misconnection is reduced.

[0042] In this specification, engagement of the connector 330 and the connecting member 310 refers to a state in which the connector 330 and the connecting member 310 are in contact with each other. In this state, the connector and the connecting member may be connected, disconnected, or partially connected.

[0043] The compression system 100 shown in exemplary form in Figure 1 comprises a pump 110, a control system 200 as shown in Figure 2, a user interface 117 or indicator unit including visual and audio elements, and at least one compression garment 120 for attachment to a patient's limb, the compression garment being attachable to at least one connection means 114 via a connector arrangement 300 including separable physical connector parts 310, 330. The connector part on the garment 330 has a body 331 including an identification component 390, enabling the controller 221 of the pump 110 to detect the location, size and type of at least one connected garment from among a number of different types. The controller 221 of the pump 110 is configured to monitor the usage of the compression garment 120 by an individual patient, both in use and not in use, to provide a time-based indication and analysis of its status.

[0044] Figure 2 shows a logical organization of the components of the control system 200 of the compression system 100, including the controller 210, or main system microcontroller, disposed therein that provides the software-based functionality. In this Figure 2, the control surface organization is shown with individual functional and logical components. Although the components are shown as individual components for ease of explanation, it is within the scope of the invention that in some embodiments they may be physically combined.

[0045] In one embodiment, at least one garment type is provided for attachment to a patient's anatomy, e.g., an extremity such as the foot, calf, or thigh. The garment 120 provides compression directly within the patient's anatomy through its expansion. Each connected garment 120 is sensed via its identification component 390, which enables the main system microcontroller 210 to identify and set the required compression for each connected garment based on the sensed type.

[0046] The compression means 221, 222 provide feedback to the main system microcontroller 210 regarding the degree of engagement with the anatomical structures and the effectiveness of the compression. Compression is monitored by the main system microcontroller using a pressure measurement element 230, allowing real-time control and delivery of compression from the system 100 to the garment 120. Alternatively, feedback and reporting from the fluid source 110 (e.g., an air compressor) can be used to detect operating conditions and ensure consistent delivery of compression to the anatomical region.

[0047] The main system microcontroller 210 can provide visual feedback to the user regarding the status of the compression system 100 via a user interface 117, 117a-117d, which can consist of visual indicators such as an LCD display as shown in detail in FIG. 1 and FIG. 3a-3d, and / or other LED-based indicators disposed as part of the compression system. The user interface 117 can also provide audible feedback to the user using a speaker, piezoelectric sounder, or other form of audible device. The user interface 117 can also provide control of the compression system 100 through selection of system operations, operating modes, settings, and other user-selectable characteristics using buttons, keypads, and other forms of user input. FIGS. 3a-3d show an exemplary graphical user interface of a compression system known in the prior art in the form of an LCD panel with a full set of available graphic icons displayed. They provide an exemplary display of the various functions and operating states of the compression system during various operating modes and at various times.

[0048] A timing element 240 is provided that can be used to provide time-based information, such as timing periods, clock and calendar information, that can be used by the operating software and stored in system memory.

[0049] A storage memory element 250 is provided that allows the main system microcontroller 210 to store data and records relating to both periods of system use (i.e., intended and prescribed periods) as well as periods of non-use (i.e., periods contrary to intended or prescribed). The storage memory element also includes timing information provided by a timing element. This allows non-volatile storage of data relating to typical periods of patient care (e.g., periods lasting hours and days) and data relating to pump usage by multiple patients (e.g., over weeks and months). This data can be accessed and analyzed to provide information regarding the effectiveness of system usage by staff within a healthcare facility.

[0050] The main system microcontroller 210 can communicate this usage information from the storage memory 250 to an external device using a remote communication element 260 (e.g., a wireless connection using Bluetooth or Wi-Fi, or a wired connection such as USB).

[0051] 1, the system 100 further comprises a user interface, indicator unit 117. The indicator unit 117 is operatively connected to the main system microcontroller 210, i.e., controller. The indicator unit 117 is configured to provide an indication to a user based on the position signal.

[0052] In one embodiment, an indicator unit 117 is provided on the pump 110, i.e., the indicator unit 117 is attached to a casing of the pump 110. In one embodiment, the indicator unit may also be attached to the connecting member 310, so that a user is provided with instructions while operating the pump 110.

[0053] In one embodiment, the indicator unit 117 may be a display unit, such as an LCD display.

[0054] In one embodiment, the indicator unit includes an LED indicator, the illumination state of the LED being dependent on the LCD state of the first and second display states.

[0055] In a further aspect, an LED-based indicator unit changes from a constant lighting state to a blinking lighting state based on the state of the LCD.

[0056] In one embodiment, the indicator unit 117 is configured to provide an indication to a user in response to the distal portion 331 being in an intermediate position along the articulation axis CA between the coupled position and the uncoupled position.

[0057] In one embodiment, a controller 210 is provided on or within the pump 110 .

[0058] As shown in FIGS. 3 a - 3 d , the indicator unit 117 is shown in the form of a graphical LCD display having a full range of icons associated with various different functions related to the compression system 100 .

[0059] FIG. 3b highlights a particular icon in the panel shown in FIG. 3a that is used to display the usage status of the system when no garment is connected, i.e., before any use by the patient. This shows the display when the product is not being used for prophylaxis. The icon indicates the usage monitoring invention. Other icons are also present, but have been removed for clarity of illustration. The indicator unit 117 indicates that there is no connected garment currently detected as being connected to the pump. The total past usage of the system can be shown in the lower right corner 118 of the indicator unit 117 in the form of a three-digit digital elapsed time meter that can be used to indicate a period of time in hours and minutes. The display also includes multiple graphic icons of exemplary limb sections for each compression output of the compression system.

[0060] FIG. 3c shows an exemplary display of the compression system 100 when the system detects the connection of two garments intended for connection to the patient's legs, specifically the calves. A set of icons of the connected garments is displayed, and usage information is displayed in the form of a three-digit digital elapsed time meter in the lower right corner 118 of the display, which is associated with continued use of the garments. FIG. 3c shows only those icons from FIG. 3a that are relevant for displaying the first display state associated with monitoring usage by the patient. This includes icons associated with anatomical structures such as the limbs, including the feet, legs and calves, various garment icons attached to the limb regions, and a timing display including a three-digit seven-segment numeric display. The nature of the garment icons displayed depends on what is detected by the garment detection means. It is within the scope of the present invention to use different icons for different garment types. The timing information displayed in the timing display 118 is associated with the monitored usage of the connected garments.

[0061] Figure 3d shows an example of a second status display for a compression system operating with the same connected calf garments as detailed in Figure 3c, but without the patient's limbs present. The usage information displayed in the lower right corner 118 of the display can be in the form of a three digit elapsed time meter, with the timing information being changed to relate to the absence of use of the garments.

[0062] One aspect of the invention is that the indicator unit 117, when in the second display state, involves a flashing limb effect alternating between the limb icons circled in Figures 3c and 3d, with the alternating display of the icons being in the form of flashing or a change in display contrast level.

[0063] Thus, this condition is one in which the patient's limb is sensed as not being present and the compression system is not providing the intended treatment or prevention.The timing information displayed on the timing display is related to the monitored lack of use of the connected garment.

[0064] Figure 4 pictorially illustrates one example of a typical usage scenario for a patient using the compression system of Figure 1. The figure graphically illustrates periods of use and non-use and the effect on the first and second display states provided by the LCD seven-segment display.

[0065] This use scenario includes discrete periods of use (A, C, E) interspersed with periods of non-use (B, D), which may last from minutes to hours within typical patient care and are typical of those experienced in a hospital environment. Examples of use periods A, C, E include operation of the compression system while the patient is in a hospital bed, during surgery or while sleeping, and when the compression system is specifically needed and intended for use. Examples of typical non-use periods B, D include when the patient is undergoing a diagnostic procedure (e.g., x-ray) or during personal hygiene (bathing / toileting), when use of the compression system is not specifically intended.

[0066] A further important consideration is that periods of non-use may occur during the time that the system is intended to be in actual use. An example of this scenario would be when a garment is physically removed from a patient's limb for examination, and then the caregiver neglects to replace the garment. In this scenario, the patient is not receiving the prescribed treatment and is therefore at risk. This aspect is specifically monitored by the compression system 100.

[0067] The timing is described accordingly: a first use state A lasts from time T0 to T1, the period being T1-T0, and the LCD display provides a first display state in which the timed value increases between T0 and T1.

[0068] This is then followed by a non-use period B during which the second display state is shown, followed by a use period C during which the first display state is displayed, a further non-use period D during which the second display is performed, and a final use period E during which the first display is active.

[0069] Because the occurrence and duration of these individual periods of use and non-use will be unique to each patient, outcome metrics provided by the usage and performance monitoring features of the compression system can provide a means of quantifying this.

[0070] 4, the top view shows an example of the present invention of a compression system with two defined states of use and operation: a first state of use associated with intended normal operation by the patient and a second state of use associated with operation of the system in an unintended mode.

[0071] Several distinct episodes of use are depicted in the chronological sequence A, B, C, D, and E, where Episodes A, C, and E involve correct operation of the system to provide compression therapy to a patient as intended and prescribed. Episodes B and D depict use instances where compression is not applied as intended or prescribed. Many factors can lead to the situations depicted in Episodes B and D, including removal of the compression garment from a patient's limb, separation of the compression garment from the pump, or detection of a fault condition such as a leak.

[0072] Each episode is monitored and timed as shown in FIG.

[0073] During a first state of use, the compression system 100 provides a first type of display to the user. The first type of display includes an increasing elapsed time that is the cumulative duration of operation in the first state across multiple use episodes (e.g., A, C, E). This time is monitored and displayed in the form of delivered prophylaxis time, for example, initially in minutes only, changing to hours and minutes after 60 minutes.

[0074] During the second state of use, the compression system provides the user with a second, different type of display, the second display being in the form of an increasing time associated with the time spent in the second state of a particular episode of use, the time being initially displayed in minutes, and then later in hours and minutes.

[0075] In a further embodiment, a second period of time can be accumulated from each episode of non-use.

[0076] The advantage of using two displays is that only information relevant to the status of the compression system is presented to the user, which promotes ease of use and comprehension of the timing information provided.

[0077] When the usage status of the compression system changes from a first state to a second state, the display type of the first state is automatically erased, and instead, only the display type of the second state is displayed.

[0078] When the usage of the compression system changes from the second operating state to the first operating state, the compression system automatically reverts to providing only the display type of the first state.

[0079] The timing of the episodes is shown in FIG. 4 and Table 1, along with the formulas for the displayed values ​​relative to time for each display type based on the elapsed time 't' in FIG.

[0080] TIFF2024538733000002.tif106170

[0081] Table 1 above shows that the first indication state is obtained only when the pump is being used and the compression system is effectively providing prophylaxis to the patient, whereas the second indication state is provided only when the compression system is not providing prophylaxis.

[0082] In the first display state, the elapsed usage timing information increments during episode A, increments through episode C, and then increments again through episode E to provide a total value over the duration of patient care. The first display state is not available during non-use episodes where the elapsed timing value does not increment.

[0083] This situation is also illustrated in FIG.

[0084] FIG. 5 is a flow chart detailing an exemplary embodiment of the present invention that allows the compression system to determine which indication state to provide. In FIG. 5, the compression system can monitor each connected garment, control the inflation of the garment in real time, and detect the presence of a limb within each compression garment during each inflation. This is accomplished by analysis of measurements and parameters taken at various times during the inflation process. These measurements include at least one of the following: pressure within the connected tube 114, 112, pressure within the connected inflated garment 120, type of connected garment, and compressor parameters involved in actually providing the particular inflation state (e.g., compressor drive waveform amplitude, applied drive waveform frequency, current, voltage, etc.).

[0085] A measure of prophylactic delivery is created by combining the above parameters and compared to the expected measurement for that particular connected garment type and the measurement achieved in past inflations of that connected garment. The system looks for a significant difference between those two analysis points and uses that difference to determine the presence of a limb.

[0086] The compression system may alternate between a first indicating state and a second indicating state based on a measurement of the presence of a limb within the garment. The change in indicating state may occur with operation of only a single connected garment or with operation of two connected garments. The change in indicating state may occur when either one of the two connected garments is detected as not being used with the patient's limb.

[0087] It is within the scope of the present invention to add additional parameters to the algorithm and generate additional outputs with that algorithm.

[0088] When the compression system detects that it is not delivering prophylaxis to the patient, it can adapt its instructions to the user. User instructions include LCD-based instructions, LED-based instructions, and audio instructions from the pump. Thus, the priority and level of user instructions can be adapted as needed in the clinical setting. This includes graded and progressive instructions that are proportional or related to the duration of the non-use episode. Thus, when the period of lack of use is short, a low level of instructions can be provided to the user, but this can become stronger as the period increases and the situation becomes more severe.

[0089] In a preferred embodiment, in both the first and second indication states, a flashing green LED indication is provided at multiple locations on the compression system if a duration of 10 compression cycles is detected without delivery of correct prophylaxis. The use of multiple LED indications on the compression system allows for visibility from multiple directions, thereby allowing clinical staff to easily determine the operational status of the compression system and its use from various directions without having to approach or manipulate the compression system.

[0090] This LED indication can be given a higher priority as the time of non-use increases, for example by using a yellow alarm LED instead of a green LED, which would occur if the number of cycles without adequate protection reached, for example, 10 cycles.

[0091] It is also within the scope of the present invention that the display and timing data provided by the compression system usage monitoring display may be reproduced at other locations physically separate from the compression system.

[0092] The compression system may optionally include a means for communicating its status to a remote facility, such as a central monitoring unit, computer, tablet device, phone, or another device capable of displaying the status of at least one compression system. This communication means may utilize wireless technology (such as Bluetooth, ZigBee, or Wi-Fi) and / or a dedicated wired connection to another device that can display the information itself or provide onward communication, such as a hospital bed or other medical device, such as a support surface / mattress pump.

[0093] In one embodiment, a compression system 100 for monitoring and controlling fluid pressure during compression therapy is provided. The system includes at least one inflatable or deflatable compression garment 120, an air pump 110 for regulating air pressure to the compression garment when connected to the air pump, an indicator unit 117, and a controller 221 operatively connected to the air pump 110 for monitoring usage of the at least one compression garment 120. The indicator unit 117 includes a first display indicator 117a, 117c associated with a monitored usage time of the at least one compression garment 120 in a first operating state of the compression system 100 when the compression garment 120 is applying compression to a patient, and a second display indicator 117b, 117d associated with a monitored usage time of the garment in a second operating state of the compression system 100 when the compression garment is not applying compression to a patient. The indicator unit 117 is configured to automatically switch between the first and second display indicators associated with the operating states of the compression system 100.

[0094] In one embodiment, the compression system 100 includes an identification component 390 associated with a type of compression garment 120 and attached to a connector 330 of the compression garment 120. The air pump 110 is configured to adjust the air pressure to the compression garment 120 based on the type of compression garment. The system includes at least one pressure sensor for measuring the pressure present in at least one inflatable chamber of the connected compression garment 120 during compression therapy to generate a signal corresponding to the pressure in the inflatable chamber. The pressure sensor provides a signal including a characteristic corresponding to the presence of a human body limb or part thereof located within the at least one compression garment 120 during application of compression. The pressure sensor indicates that the compression level of the compression garment 120 has changed as a result of the human body limb or part thereof being removed from the compression garment (120) compared to the characteristic measured during a previous inflation. The total monitoring time when a human limb or part thereof is present within the connected compression garment 120 compared to the monitoring time when the limb or anatomical structure is currently detected as not being present within the connected compression garment 120 is monitored and provided by the controller 221 and visually presented to the user on the indicator unit 117.

[0095] In one embodiment, the identification component 390 is made from a ferrite, steel or brass material.

[0096] In one embodiment, the first display indicator 117a, 117c includes the total time associated with the delivery of the compressions in minutes or hours.

[0097] In one embodiment, the second display indicator 117b, 117d includes the duration of time, in minutes or hours, associated with the current compression deficit.

[0098] In one embodiment, a visual warning is provided when the second display indicator 117b, 117d is active and under-delivery of compressions exceeds a threshold, hi one embodiment, the visual warning includes activation of an LED or LCD unit.

[0099] In one aspect, the monitored usage time is configured to be reset by the user.

[0100] In one embodiment, a first operating state is associated with correct operation of the compression system 100 and a second operating state is associated with malfunctioning operation of the compression system 100 .

[0101] In one aspect, the fluid output is maintained in both the first and second operating conditions.

[0102] In one embodiment, the compression garment 120 is configured to be worn on a limb or portion thereof of a human body, and the period of non-connection time is monitored by the compression system 100 and displayed as a second operating state and shown as a current duration on the indicator unit 117.

[0103] In one embodiment, the compression garment 120 is configured to be worn on a limb or part of a human body and the period of time that it is removed from the limb is monitored by the control unit and displayed on the indicator unit 117 .

[0104] In one embodiment, the indicator unit 117 is an LCD display that includes a graphic icon of a limb or portion thereof, which flashes or otherwise alternates in contrast when the compression system 100 is in the second operational state.

[0105] In one embodiment, the indicator unit 117 is an LCD display that provides an indication of product non-use over time, initially in minutes.

[0106] In one embodiment, the indicator unit 117 is configured to provide an indication of non-use of the product over time and to provide a progressive response as monitored non-use increases over time.

[0107] In one aspect, a compression garment 120 is provided for attachment to a limb or portion thereof of a human body, and a system 100 for monitoring and controlling fluid pressure during compression therapy monitors the duration of time connected and totals the time in a first operating state for display on a user interface 117 of an air pump 110 of the compression system 100.

[0108] In one aspect, a compression system 100 for monitoring and controlling fluid pressure during compression therapy is provided. The system comprises at least one compression garment 120, an air source 110 for regulating air pressure to the at least one compression garment 120 when connected to the air source, a controller operatively connected to the air source 110 and configured to monitor usage of the at least one compression garment 120, and a limb detection unit. The at least one compression garment 120 comprises a connection unit 330 having an identification component 390, the identification component 390 being made of ferrite, steel or brass. The limb detection unit is configured by the compression system 100 based on the nature of the identification component 390 of the compression garment.

[0109] In one embodiment, the system includes an extremity detection algorithm that includes at least one parameter that is set by an identification component 390 of at least one compression garment 120 when connected to the compression system 100.

[0110] In one embodiment, the system includes two compression garment connection ports 310 and the limb detection algorithm is applied separately and independently to each compression garment connection port 310 based on the value of the identification component 390 when attached to each compression garment connection port 310.

[0111] In one aspect, a method is provided for monitoring and controlling fluid pressure during compression therapy in a compression system 100. The system 100 comprises a pump 110, at least one inflatable or deflatable compression garment 120, an indicator unit 117, and a control unit for monitoring usage of the at least one compression garment 120. The indicator unit 117 includes a first display indicator 117a, 117c associated with a monitored usage time of the at least one compression garment 120 in a first operating state of the compression system 100 when the compression garment 120 is applying compression to a patient, and a second display indicator 117b, 117d associated with a monitored usage time of the garment in a second operating state of the compression system 100 when the compression garment is not applying compression to a patient. The method includes step 1 of activating the compression system, step 2 of identifying a connected compression garment, step 4 of initiating preventive action, step 5 of detecting and displaying the usage status of at least one compression garment 120 of the compression system 100, and step 5 of automatically switching between first and second display indicators 117a, 117b, 117c, 117d associated with the operating status of the compression system 100.

[0112] In one embodiment, the method further comprises the step of detecting the presence of a human body limb or part thereof within the at least one compression garment 120, wherein the detecting and indicating step 5 comprises comparing a first set of detected data to a subsequent set of detected data, and a difference between the first and subsequent sets of detected data is compared to a threshold value established by the identification component 390 of the at least one compression garment 120.

[0113] The terms used herein are for the purpose of describing particular embodiments only and are not intended to be limiting of the present invention. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms unless the context clearly indicates otherwise. Furthermore, it is to be understood that as used herein, the terms "comprises", "comprising", "includes" and / or "including" specify the presence of stated features, wholes, steps, operations, elements and / or components, but do not exclude the presence or addition of one or more other features, wholes, steps, operations, elements, components and / or groups thereof.

[0114] Unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meaning as commonly understood by those skilled in the art to which the present invention belongs. Furthermore, it should be understood that the terms used herein should be interpreted as having a meaning consistent with the meaning in the context of the present specification and related art, and should not be interpreted in an idealized or overly formal sense unless expressly defined herein.

[0115] The principles, preferred embodiments and modes of operation of the present invention have been described above. However, the present invention is to be considered as illustrative rather than restrictive, and is not limited to the specific embodiments described. The various features of the various embodiments of the present invention can be combined in combinations other than those expressly described. It is therefore to be understood that changes can be made in those embodiments by those skilled in the art without departing from the scope of the invention, which is defined by the following claims.

Claims

1. A compression system (100) for monitoring and controlling fluid pressure during compression therapy, comprising: at least one inflatable or deflatable compression garment (120); an air pump (110) for adjusting the air pressure to said compression garment when connected to the air pump; an indicator unit (117); a controller operatively connected to the air pump (110) for monitoring the usage of the at least one compression garment (120); The indicator unit (117) a first display indicator (117a, 117c) associated with the monitored duration of use of the at least one compression garment (120) in a first operating state of the compression system (100) when the compression garment (120) is applying compression to a patient; a second display indicator (117b, 117d) associated with the monitored duration of use of the compression garment in a second operating state of the compression system (100) when the compression garment is not applying compression to the patient; The system, wherein the indicator unit (117) is configured to automatically switch between first and second display indicators associated with an operating state of the compression system (100).

2. 2. The system (100) of claim 1, an identification component (390) associated with the type of compression garment (120) and attached to a connector (330) of the compression garment (120); the air pump (110) is configured to adjust the air pressure to the compression garment (120) based on the type of compression garment; the system comprising at least one pressure sensor for measuring pressure present in at least one inflatable chamber of a connected compression garment (120) during compression therapy and generating a signal corresponding to the pressure in said inflatable chamber; the pressure sensor provides, during compression, a signal including a characteristic corresponding to the presence of a human limb or part thereof located within the at least one compression garment (120); the pressure sensor indicates that a limb or part thereof has been removed from the compression garment (120) resulting in a change in the compression level of the compression garment (120) compared to a characteristic measured during a previous inflation; The system is characterized in that the total monitored time when a human limb or part thereof is present within the connected compression garment (120) compared to the monitored time when no limb or anatomical structure is currently detected within the connected compression garment (120) is monitored and provided by the controller and visually presented to the user on the indicator unit (117).

3. 3. The system (100) of claim 2, The system, wherein the identification component (390) is made of a ferrite, steel, or brass material.

4. The system (100) according to any one of claims 1 to 3, The system wherein the first display indicator (117a, 117c) includes a total duration in minutes associated with the application of compressions.

5. The system (100) according to any one of claims 1 to 3, The system wherein the first display indicator (117a, 117c) includes a total duration in hours associated with the application of compressions.

6. The system (100) according to any one of claims 1 to 3, The system wherein the second display indicator (117b, 117d) includes a duration in minutes associated with no compressions currently being applied.

7. The system (100) according to any one of claims 1 to 3, The system wherein the second display indicator (117b, 117d) includes a duration in hours associated with no compressions currently being applied.

8. The system (100) according to any one of claims 1 to 3, A system wherein a visual warning is provided when the second display indicator (117b, 117d) is active and the lack of applied compression exceeds a threshold.

9. 9. The system (100) of claim 8, The system wherein the visual alert comprises activation of an LED or LCD unit.

10. The system (100) according to any one of claims 1 to 3 and 9, The system is configured such that the monitored usage time is reset by the user.

11. The system (100) according to any one of claims 1 to 3 and 9, The system, wherein the first operating state is associated with correct operation of the compression system (100) and the second operating state is associated with malfunctioning operation of the compression system (100).

12. The system (100) according to any one of claims 1 to 3 and 9, The system wherein fluid output is maintained in both said first and second operating conditions.

13. The system (100) according to any one of claims 1 to 3 and 9, The compression garment (120) is configured to fit over a limb or part thereof of the human body, and the duration of the disconnection time is monitored by the compression system (100), which time is displayed as the second operating state and shown as the current duration on the indicator unit (117).

14. The system (100) according to any one of claims 1 to 3 and 9, The compression garment (120) is configured to fit over a limb or part of a human body, and the duration of removal from the limb is monitored by the control unit and displayed on the indicator unit (117).

15. The system (100) according to any one of claims 1 to 3 and 9, The system wherein the indicator unit (117) is an LCD display including a graphic icon of a limb or portion thereof, the icon flashing or otherwise alternating in contrast when the compression system (100) is in the second operating state.

16. The system (100) according to any one of claims 1 to 3 and 9, The system is characterized in that the indicator unit (117) is an LCD display that provides an indication of product non-use over time, initially in minutes.

17. The system (100) according to any one of claims 1 to 3 and 9, The system, wherein the indicator unit (117) is configured to provide an indication of non-use of the product over time and to provide a progressive response as monitored non-use increases over time.

18. A compression garment (120) for application to a limb or part thereof of a human body, comprising: A compression garment characterized in that a system (100) for monitoring and controlling fluid pressure during compression therapy monitors the duration of connection, totals the time in the first operating state, and displays it on a user interface (117) of an air pump (110) of the compression system (100).

19. A compression system (100) for monitoring and controlling fluid pressure during compression therapy, comprising: at least one compression garment (120); an air source (110) for regulating air pressure to said at least one compression garment (120) when connected to said air source; a controller operably connected to said air source (110) and configured to monitor the usage of said at least one compression garment (120); a limb detection unit; said at least one compression garment (120) comprising a connection unit (330) having an identification component (390); said identification component (390) being made from ferrite, steel or brass; The system is characterized in that the limb detection unit is configured by the compression system (100) based on the nature of an identification component (390) of the compression garment.

20. 20. The system (100) of claim 19, 1. A system comprising a limb detection algorithm, the algorithm comprising at least one parameter, the parameter being set by an identification component (390) of the at least one compression garment (120) when connected to the compression system (100).

21. 21. The system (100) of claim 20, A system comprising two compression garment connection ports (310), wherein the limb detection algorithm is applied separately and independently to each compression garment connection port based on the value of the identification component (390) when attached to each compression garment connection port (310).

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