CONTROL UNIT, SYSTEM AND METHOD FOR ANALYZING COMPRESSION THERAPY USE - Patent application

Abstract

A control unit, system and method for analyzing the application of compression therapy to a patient's limb or anatomical structure using at least one inflatable compression garment that includes at least one inflatable chamber.

Description

[Technical field]

[0001] The present invention relates to a control unit (i.e., controller), system and method for analyzing the application of compression therapy to a patient's limb or anatomical structure. In particular, the present invention relates to the operation and analysis of a compression therapy system for use with a patient, the compression therapy system including a coupling assembly for fluidly connecting at least one inflatable / deflatable garment to a hydraulic control system. The present invention further relates to a system and method for analyzing the degree of compression therapy applied to a patient's limb or anatomical structure over time and identifying and selecting options for improving the prophylaxis applied. [Background technology]

[0002] The present invention relates to pneumatic systems, and in particular to pneumatic systems having an inflatable / deflatable article, e.g., a compression garment, connected to a fluid source, e.g., a pump. It is known that use of such systems often involves multiple separate periods of patient use separated by periods of non-use. These periods may occur multiple times a day, and may also occur across multiple nursing shifts or days during which the patient uses the system.

[0003] In view of the above, there is a need for a system and method that addresses and mitigates the risk of misuse associated with compression systems when the patient's limb is not physically located within the garment when the user connects the garment and initiates system operation to provide protection, resulting in the condition not being detected for some time without the intended protection being provided. Another related example is when the system is properly connected and set up, but then the patient removes the garment when the clinician is not present. Summary of the Invention

[0004] The present disclosure relates to systems and methods for analyzing and facilitating the clinical use of compression therapy on a patient's limbs or anatomical structures.

[0005] Usage data relating to operation of the compression system is recorded. It is an aspect of some embodiments of the present invention to provide users with monitoring and indications of the extent of usage with the intent of encouraging increased usage, and to provide indications to clinicians based on this monitored usage to assist in managing broader aspects of a patient's VTE prevention regimen, thereby seeking to mitigate, alleviate or eliminate, singly or in any combination, one or more of the above-mentioned deficiencies and shortcomings in the art.

[0006] One aspect of the present invention relates to a system, method and control unit for controlling compression therapy to a patient's limbs or anatomical structures, including application individually or in combination to areas such as the foot, calf, thigh or arm.

[0007] One aspect of the invention relates to a control unit for analyzing the application of compression therapy to a patient's limb or anatomical structure using at least one inflatable compression garment including at least one inflatable chamber. The control unit includes an identification component for detecting a type of at least one compression garment used during compression therapy and disposed within a connector of the at least one compression garment, an air pump for adjusting air pressure to the at least one compression garment based on the detected type, and at least one pressure sensor for measuring pressure present in at least one of the inflatable chambers of the at least one connected compression garment during compression therapy to generate a signal corresponding to the pressure in the chamber. Further, the pressure sensor provides a signal during application of compression, the signal including a characteristic indicative of the presence of the limb or anatomical structure within the at least one compression garment. Further, the pressure sensor indicates a change in the compression level of the at least one compression garment as a result of removal of the limb or anatomical structure from the at least one compression garment, compared to a characteristic of the signal during a previous compression. Further, a visual indication is provided by the system to the user based on the monitored time when the limb or anatomical structure is present within the at least one connected garment, and a visual indication is provided by the system to the user based on the monitored time when the limb or anatomical structure is detected as not being present within the at least one connected garment.

[0008] One aspect of the present invention relates to a compression system for analyzing usage of compression therapy using at least one compression garment, the compression system including a user interface including a first display indicator associated with usage of the at least one compression garment when the compression system is in a first operational state and a second display indicator associated with usage of the at least one compression garment when the compression system is in a second operational state.

[0009] One aspect of the invention relates to a method for analyzing usage of compression therapy using at least one compression garment of a compression system with a user interface, the user interface including a first display indicator associated with usage of the compression garment when the compression system is in a first operational state and a second display indicator associated with usage of the compression garment when the compression system is in a second operational state, the method including monitoring the time the compression garment is in each operational state.

[0010] The features of the embodiments described above may be combined in any combination. [Brief description of the drawings]

[0011] 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 according to one embodiment of the present invention. [Diagram 2] FIG. 2 shows a flow chart of a compression system according to one embodiment of the present invention. [Diagram 3] 3a-3d illustrate one embodiment of a graphical user interface according to one embodiment of the present invention. [Figure 4] FIG. 4 illustrates a timing diagram of the 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 compression system according to one embodiment of the present invention. [Figure 6] FIG. 6 shows a system diagram of a logical overview of the algorithms used to provide usage monitoring functionality of a compression system according to one embodiment of the present invention. [Figure 7] FIG. 7 shows a graph visualizing the operation of the usage monitoring feature of a compression system according to one embodiment of the present invention, illustrating a case where usage is greater than a preferred target. [Figure 8] FIG. 8 is a graph visualizing the operation of the usage monitoring feature of a compression system according to one embodiment of the present invention, illustrating a case where the calculated usage is less than the preferred target. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] 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.

[0013] Within the field and scope of compression systems intended for venous thromboembolism (VTE) prevention, it is known that such systems are used at different times and for different durations throughout the day. As a result, they are used by different staff members throughout the day and responsibility is transferred from shift to shift. It would therefore be beneficial if the preventive or therapeutic activities of one nursing shift could be verified by a subsequent nursing shift. This is particularly useful in busy acute care facilities where the overall preventive or therapeutic operation of the compression system relative to an individual patient can be easily verified by any clinician at any time on the compression system.

[0014] In one aspect of the invention, the system can use monitoring of past usage to provide recommendations regarding changes in behavior, automatically correct settings, or provide the clinician with a progress indication regarding adherence to predetermined goals.

[0015] A further aspect of potential misuse associated with compression systems is when a user connects a garment to initiate system operation for protection, but the patient's limb does not physically fit within the garment. As a result, the intended protection is not provided and the condition may go undetected for some time. Another related example is when the system is properly connected and set up, but the patient subsequently removes the garment when the clinician is not present. The present invention aims to monitor both such types of instances, record the timing associated with these events, and indicate the status to the clinician through usage-monitored displays and alerts.

[0016] The present invention involves and combines two distinct and separate elements: usage monitoring and performance monitoring.

[0017] Usage monitoring covers the actual usage of a product in clinical practice and is based on a combination of the following aspects: - Detection of one or more types of garments attached to a compression pump of a compression system, enabling identification and automatic validation of one or more types and variations of compression garments connected to the pump and the associated compression monitoring parameters that best suit the connected garments. - Time-based monitoring and recording of the duration of pumping in the selected garment or garments, including monitoring a recording of the duration of pumping when the required number of limbs are identified as being present in the garment during inflation, in the form of multiple data records in the form of elapsed time measurements of start / stop times and an incrementing elapsed time counter, thereby providing multiple data records with a time basis, thereby enabling the system to determine when, for how long and how effectively prophylaxis was or was not administered.

[0018] This is combined with the following elements: -Algorithm-based, multi-parameter analysis of delivered compression therapy based on data collected over time by usage monitoring, which is compared to pre-defined performance targets that are clinically relevant for each individual patient.

[0019] Simple timers associated with recording elapsed pump usage are known to be built into many products that contain compression pumps. A novel aspect of the present invention is the analysis of both the individual durations during which each patient used the compression system and the individual durations during which the system was not used.

[0020] This analysis is used to calculate a number of metrics related to the actual degree of past performance of the compression system.

[0021] In a further embodiment, at least one calculated indicator is provided to the user by an LCD screen of the compression system. The displayed indicators can be provided in numerical form, such as values, scores, percentages, or in graphical form, such as bar graphs, icons, or other non-numerical image formats. In one embodiment of the invention, the set of indicators is continuously updated so that changes in the degree of use or non-use of the compression system are reflected in the indicators and the associated visual display. In at least one embodiment of the indicators, the relative proportions of recent use time and recent non-use time are compared to comparable proportions in previous periods. This allows early identification of deviations from long-term usage in the event of positive or negative effects on product usage.

[0022] In addition, one or more of the following elements may be incorporated: -Incorporating a real-time clock (RTC) timing device can provide temporal details such as actual time of system operation. That information can be correlated with the daily timing of other aspects of the patient care experience that may affect or prevent use of the VTE system (e.g. bathing / toileting / examination / diagnostic procedures / medication, etc.) and whose times are typically scheduled or otherwise known and thus recorded in the patient's care record. Displaying indicators of prophylaxis performed to date allows for improved care management, auditing and reporting of VTE prophylaxis for individual patients. -RTC's start / stop timestamp based approach also allows for the storage of time-stamped records in digital memory in the form of a log of individual events of use and non-use, including the clear recording of time and duration of activities associated with clinician actions resulting in the pump not being used, such as removing clothing from the pump and / or physically powering the pump off. Thus, individual episodes of use are identified and recorded for later analysis and reporting to the clinician, as well as for inclusion in the patient's electronic medical record (EMR).

[0023] In one aspect of the invention, rather than recording only the duration of each episode, both the start and stop timestamps of the event are used. From this base data, it is possible to build a detailed and relevant timed log of system usage and precautions taken. Further records can be included in the log, such as system warnings and pump operational settings.

[0024] Performance monitoring can extend and build upon the usage monitoring data described above to identify and generate a number of parameters and behavioral indicators related to the effectiveness of the prophylaxis administered to the patient over time. This provides the user with feedback on the amount of prophylaxis delivered over time using an algorithm-based score based on the monitored usage and other additionally sensed and recorded parameters. Time of day is important as an additional criterion and data point when analyzing product usage, since the state of the human body changes significantly between a patient's sleep and wakefulness states, and certain treatments (e.g., medicines) applied at specific times or periods can affect the effectiveness of the administered compression.

[0025] The present invention may also utilize a proprietary algorithm to provide visual recommendations to the user in the event of insufficient usage compared to a predefined or recommended overall threshold or target. This threshold or target may be associated with or selected or configured by an identification component associated with each connected garment type, or may be more generally set by the control system (e.g., using a portion of the user interface located on the pump) based on clinical input. In one aspect of the present invention, an automatic setting procedure upon connection of the garment to the pump may set different thresholds for each garment type based on an aspect of the identification component located on the connector of the particular garment type attached to the pump. This allows for garment-specific settings to be created among multiple settings for the target or threshold. In a further aspect of the present invention, the threshold setting may be set to a first value when the garment is newly manufactured and unused, and changed or adapted to a second value when the same garment is inserted into a compatible approved pump for initial use. This aspect allows the pump to easily distinguish between a new, unused garment being worn by a patient and a previously used garment that may require different behavior in terms of the compression parameters or monitoring algorithms employed.

[0026] This same embodiment and process is equally applicable when a garment undergoes reprocessing, including cleaning or sterilization, after a first patient use and before a second patient use, thereby providing a means for indicating to the clinician that a garment with a limited operational life is identified as not being brand new. This embodiment combines the benefits of the thresholding of the present invention with a secondary benefit associated with performance monitoring of the garment's operation. As a compression garment ages, depending on the materials used for each type, its material properties may change, thus affecting its function or reliability. This result may occur either through the effects of repeated inflations from continued use on a single patient, through multiple reprocessing cleaning and testing cycles, or through use by multiple patients. To provide optimal operation, the present invention may utilize an identification component to assist the algorithm in measuring the operation of the compression garment when in use.

[0027] A further aspect of the present invention includes the use of multiple identification components (size, material, location) located on the garment connector to enable the pump control system to uniquely identify each type or family of compression garment among multiple types of compression garments whose operation is being monitored.

[0028] The use of algorithms to provide usage indicators and sensed compliance during actual use is known in the prior art of intermittent pneumatic compression (IPC) therapy (e.g., Wright, US 9,889,063). The present invention differs in that it combines various indicators related to VTE prevention, a garment identification component within each attached garment connector, and monitoring of usage of each garment and pump during operation to provide prevention / therapy or when the pump is not in active pneumatic operation, as well as making associated recommendations and decisions to assist in clinical decision making for both current and future use.

[0029] The compression system may include one or more of the following aspects. - identifying a particular garment type fluidly connected to the pump by an identification component disposed on the garment connector and sensed by the compression system, wherein at least one generated parameter in the form of an indicator based on an analysis of recent system usage is related to the degree of prophylaxis delivered over a defined time frame for the garment type associated with the identification component. At least one parameter has a weighting and forms part of a decision algorithm executed by software in the controller of the compression system. The pump automatically switches on or otherwise changes its user interface in response to connection of the aforementioned garment connector. -The pump will automatically start applying the treatment / prophylaxis based on the connection of the garment connector as described above. -The time frame of the analysis is associated with or based on actual elapsed time (e.g., clock / calendar time as monitored by RTC or equivalent) and is associated with at least one of the following: connection of said garment connector, removal of said garment connector from the pump, or use of the pump's element user interface. The time period for the analysis is further selectable from among a plurality of time periods via the pump control system, a sensed identification component, or user selection, and encompasses a variety of different selectable options, such as between specific selectable dates / times or a timed period. Alternatively, the time period may more simply include a period including the last few hours or days, or a longer period of time total of an individual patient's system usage. The generated parameters in the form of calculated indicators are related to recent monitored usage of the compression system compared to a recent monitored lack of usage of the compression system, defined as a time when the compression system is not intentionally operating (e.g. when it is switched off or when prophylaxis is not in place). The generated parameters in the form of calculated indicators are correlated to monitored usage of the system compared to recent monitored usage when it is detected that the compression system is being used intentionally but the garment is not on the limb or has been removed from the limb. - Generated parameters in the form of calculated indicators are associated with recent system usage associated with each available system operating mode or prevention type. The range of operating modes / prevention types is selectable within the control system. -The generated parameters in the form of calculated indicators are associated with the recent system usage and the type of connected garment. The generated parameters in the form of indicators are associated with recent system usage and with the alert status of the system and associated connected garments. -The generated parameters in the form of indicators are associated with recent system usage and measurements of sensed parameters (e.g. measured from the limbs) are associated with applied prevention. - The generated parameters in the form of at least one calculated metric are associated with recent usage of the system and at least one clinical parameter is associated with a patient using the system. The clinical parameter is measured by the compression system as a function separate from compression or, alternatively, provided by an external patient monitoring device. A variety of clinical parameters may be utilized, such as vital signs (pulse rate, temperature, respiratory rate, blood pressure) and other relevant clinical measurements (e.g., oxygen saturation levels, risk factors and mobility). -The generated parameters in the form of calculated indices are linked to recent system usage and the variables are linked to the patient's VTE risk factors, general condition and care plan. An algorithm operating within the compression system uses at least one weighted parameter to provide a calculated metric for use by the compression system in its operation and / or communication to a clinician.

[0030] The above aspects and parameters can be used to provide patient-specific aspects to the analysis of system usage. Additionally, the above aspects and parameters can also be used to provide compression system specific aspects to the analysis of compression system usage when used by multiple patients.

[0031] Calculation of the parameters and indices described above is performed within the compression system using software running on a microcontroller within the compression system, and the indices are periodically calculated and updated for use as parameters within the algorithms.

[0032] The parameters and indicators are used in the present invention using a proprietary algorithm to provide an estimate of the effectiveness of current system use along with a prediction of future utilization and expected preventative performance against targets, thresholds or required usage. The results of the algorithm can be displayed to the user to recommend manual changes in use or operation, or alternatively can be used to automatically initiate changes in system operation with the goal of encouraging improved compression system usage and / or effectiveness. The algorithm results can be communicated locally via a visual display and / or communicated more broadly by the system for recording in individual patient records or other facility management systems. Visual display to the user can be via a user interface, for example, as shown in the compression system of Figures 1 and 3a-3d.

[0033] In one aspect of the invention, these monitored and calculated individual usage and efficacy parameters are stored and can be recalled for further analysis as part of individual patient records and facility management, and as part of enhanced system operation.

[0034] Each parameter is given a weighting, which allows the relative effect and importance of each of the various parameters to be taken into account in the algorithm calculations.

[0035] It is within the scope of the present invention that the weighting of those individual parameters can be adaptively changed by a user or by the algorithm itself. The individual parameters and indices are individually associated with the specific garment type being used, as indicated by an identification component associated with the connected compression garment.

[0036] In a further aspect of the present invention, the compression system includes the use of artificial intelligence techniques to update its internal algorithmic operation, such as the use of machine-based learning approaches. This includes a variety of software-based techniques, including multi-parameter analysis, predictive analytics, statistical optimization and heuristics, to further enhance the algorithm over extended periods of use. The compression system is inherently adaptive and can refine the algorithm, including elements of its operation, form or structure, based on results obtained from multiple patient usage episodes. Thus, the algorithm can improve its function and operation based on data collected from experience gained in actual system use. In conjunction with this machine learning aspect of the compression system's operation, the algorithm can provide additional indicators regarding its learning state, evolution and enhancement for subsequent interpretation and evaluation.

[0037] The compression system can also modify its function with respect to its operational compression parameters, such as pressure level, cycle time, inflation rate, deflation duration and other characteristics, based on the results of the algorithm, its parameters and indicators, and the type of compression garment attached to the system, as defined by an identification component located on one or more connectors of the attached garment or garments. This approach provides an alternative means of operation and allows for enhanced compression system operation compared to the fixed and defined operation available in the prior art. This enhancement is made possible by algorithmic analysis of data associated with the system monitored usage combined with detection of the specific garment type connected.

[0038] Output from the algorithm and individual parameters may be reported to a user (e.g., via an interface), communicated remotely (e.g., via wireless communication), or utilized by the compression system in selecting or altering operating parameters of the compression system.

[0039] As a result of this communication capability, in another aspect of the invention, the compression system can automatically change its current mode of operation based on an analysis of its past use and performance. This allows for automatic changes in the prophylaxis delivered based on the extent of use, as well as allowing for adaptive modes of operation, improving both system operation and associated patient care, for example after a period of suboptimal use. Aspects of this adaptive change in the prophylaxis action provided include modifications of typical compression parameters such as pressure waveforms, garment pressure levels, cycle times, etc.

[0040] The algorithm can be configured to provide the user with an advisory indication of recent system usage compared to long-term trends in actual usage. This approach can verify whether the clinical usage of the product for the patient is consistent with that clinically prescribed.

[0041] This functionality can be further expanded to include an optional indication of whether trends are likely to reach selectable usage thresholds. Examples of this include comparing actual usage over time to usage required to achieve a prescribed usage associated with a clinical policy or recommendation. This is illustrated in Figures 7 and 8, which show various use cases.

[0042] Figure 7 shows the time from the start (t=0) to a future time (t period) over time, the timing of which is shown on the x-axis and can be a selectable time period from hours to days. During this time period, it can be expected that a certain target usage of the compression system will be required, as shown as target usage on the y-axis. This target can be set to a value that is within the intended operating time (t), such as 75% of each 24-hour period. period ) in the form of a selectable value or percentage. The actual usage is measured (denoted in the figure as the maximum achievable value) and accumulated and displayed on the Y-axis. According to this, the first display type shows the time during active usage (t0~t1) and (t2~t period It can be seen that t increases in value while t does not increase during the period of non-use from t to t. In this example, the compression system can monitor usage and calculate a prediction that with a short period of non-use (t-t), it will be possible to achieve its target usage (shown as Max Achievable > Target). As a result, no warning is provided to the user related to the lack of protection, but instead a positive indication is provided.

[0043] FIG. 8 shows an alternative example scenario of the same compression system usage compared to FIG. 7, where the non-use period (T3-t1) is longer. As a result of this longer period, the remaining period under analysis (t period ) it is no longer possible to achieve the target amount of prophylaxis. As a result of this reduced use, a shortfall is calculated and the control system can identify that it is not possible to use the compression system sufficiently to achieve the target level in the remaining time (i.e., target value > maximum achievable). The compression system can perform predictive analysis so that it can determine at an earlier stage, (t=t shortfallThis future situation of system use / non-use (denoted as ) can be detected, thereby providing early guidance to the clinician / user. This indication allows alternative steps to be taken in the use of the compression system and in the care of the patient for the patient's clinical benefit. In a further aspect, the compression system can be configured to adapt its operation based on this identified condition, such that use and / or performance is further increased over the remaining life of the product. This increased use is accomplished by prompting with an altered indication on the user interface 117, and increased compression performance is possible through automatic changes to compression operating parameters (e.g., pressure or cycle time).

[0044] It will be apparent to one skilled in the art that the present invention, as illustrated through the examples shown in Figures 7 and 8, can beneficially highlight underuse at an earlier stage in patient care. This helps to avoid situations where a poorly prevented condition has developed and progressed, and thus helps to increase compression system usage before the condition becomes irremediable. The predictive and proactive approach of a monitored compression system can improve patient outcomes and provide an improvement over the prior art. The combination of monitoring prior usage and required target usage can provide clinicians with more information to help improve clinical outcomes with compression system usage.

[0045] It will be apparent to one skilled in the art that both the example periods of use and non-use shown in Figures 7 and 8 may be formed from many individual smaller periods. The compression system may treat those multiple periods in the same manner through an aggregate analysis approach that operates on all episodes of monitored use. Additionally, the algorithm may provide an indication in the form of a score that may be recorded in the patient record based on the nature of use along with the level and type of prophylaxis provided.

[0046] Other aspects of performance monitoring included in the present invention include monitoring the tightness of the garment worn on the patient's limb or other anatomical area using measurements taken by the compression system during inflation and deflation of the compression garment. This forms part of the present invention and provides a further means of assessing the effectiveness of the protection provided, thereby providing another aspect of usage and performance monitoring. This can be used to detect whether an individual compression garment is being worn properly by the clinician or patient and to provide control adjustments or instructions to the user. This aspect of the present invention allows the effectiveness of compression to be determined in terms of direct feedback measurements included in the algorithms described herein.

[0047] Instead of a simple compliance timer based on pump activation time, as is well known in the prior art, the monitoring system can also be used as a compliance timer that analyzes and measures the cumulative effect of multiple individual use episodes based on detection of the presence of the limb in the compression garment, thereby providing a measure of the protection actually provided to the limb. This approach seeks to identify, aggregate and analyze individual aspects of each of the patient's compression use and non-use periods and durations, rather than relying on a simple total of activation times. This approach therefore provides a more useful clinical function than traditional compliance monitoring based on a simple overall total timekeeping. The present invention provides monitoring and indication of periods during which protection is currently being applied to the patient's limb and / or periods during which protection is not being applied to the limb.

[0048] In one embodiment, the pump can monitor and display the time since the garment has been removed from the patient's limb or the time since the garment has been unplugged from the pump connector, both without accessing the pump controls. It is these uncontrollable patient activities or behaviors that the present invention monitors, as they are believed to be the main cause of inadequate prophylaxis in clinical practice. A practical example of such a situation would be if the patient removed the garment from the limb or pump connector to go to the toilet, but did not reattach the garment to the limb or pump when they returned. In such a case, the compression system would switch from a first display state to a second display state, displaying the time since the removal occurred. This embodiment allows the clinician to easily grasp such periods of underuse and the resulting lack of compliance with the prescribed care. The clinician can then make an informed decision regarding safe and appropriate intervention for the patient in terms of reapplying the garment and resuming prophylaxis.

[0049] 1 shows a general configuration of a fluid pressure control system 100, i.e. a compression system, known in the prior art and in which the present invention may be embodied. In one embodiment, the fluid pressure control system 100 is a pneumatic pressure control system, such as an air pressure control system, or is based on any type of fluid suitable for application with either a removable or integrated inflatable / deflatable article, such as a compression garment.

[0050] In an alternative embodiment, the control system and the compression garment are physically integrated with one another, with the control system mounted on the compression garment, and this integrated construction is within the scope of the present invention, as such construction also enables other aspects of the invention described herein, including usage monitoring aspects.

[0051] The fluid pressure control system 100 comprises an inflatable / deflate article 120, a pump 110, and a controller (not shown in FIG. 1) operably connected to the pump 110. The controller is operably connected to the pump 110 for controlling the pump 110. The pump 110 may be a pneumatic pump. The controller monitors usage of the pump under various conditions including a first operating state in which compression is applied to the patient's anatomy, a second operating state in which compression is applied but the patient's anatomy is not present, and a third non-compression state, such as an inactive / idle state or switched off. The time for each state is recorded and analyzed independently, and the display is configured to visually distinguish each state such that the time spent in each individual state is provided.

[0052] In one embodiment, the pump 110 is configured to control the flow of fluid to and from the inflatable / contractible article 120. The pump 110 is thus configured to inflate or deflate the inflatable / contractible article 120. In one embodiment, the control of the inflation characteristics is selected from among a number of available characteristics (e.g., compression pressure, rise time, cycle time, etc.) via a user interface of the pump. In a preferred embodiment, the inflation characteristics are selected by means of automatically detecting the connected garment type, thus reducing the need for user interaction in selecting and setting the appropriate characteristics for the connected garment type. In a preferred embodiment, the automatic detection of the garment type is performed by use of an identification component located on the garment connector that is unique to each garment type. In a further embodiment, an identification component located on the connector of each connected garment is used to select the monitoring means, algorithms and parameters for each individual connected garment type.

[0053] The fluid pressure control system 100 further comprises a coupling assembly 300 for fluidly connecting the inflatable / deflatable article 120 (eg, a compression garment) and the pump 110. The coupling assembly 300 includes a connector 330 and a connecting member 310.

[0054] 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. Thus, the connector 330 is connectable to the connecting member 310, thereby allowing fluid communication through the coupling assembly 300. In one embodiment, the fluid flows through the identification component 390, the identification component being, for example, in the form of a ferrite or brass material formed into a cylindrical or core shape, and mounted within the garment connector 330 such that the identification component 390 substantially surrounds the flow of fluid within the garment connector 330.

[0055] The compression system 100 shown in FIG. 1 in an exemplary form including a controller / pump 110 includes a microcontroller 210 disposed therein providing software-based functionality, a user interface 117 including visual and audio elements, and at least one means 114 for connecting a patient-wearable compression element to the system 100. The compression element is shown in the exemplary form of at least one compression garment 120 for attachment to a patient's limb or anatomical structure, which is attachable 300 to the connection means 114 via a connector arrangement CA including separable physical connector parts 310, 330. The garment connector part 330 has a body 331 and includes an identification component 390, which enables the controller / pump to detect the type of garment connected from among a number of different types and a number of parameters associated with monitoring the type of garment connected. The controller / pump 110 is configured to monitor the usage of the compression element / garment 120 during and without use by an individual patient to provide an indication and analysis of its status. Additionally, the system can monitor its extent of usage over time and by multiple patients within a healthcare facility, for example, to identify information and trends related to its usage.

[0056] FIG. 2 shows a logical organization of the elements of the control system 200 found in the compression system 100. In FIG. 2, the organization of the control aspects is shown with individual functional and logical elements. While the elements are shown as individual elements for ease of explanation, it is within the scope of the invention that they may be physically combined in some embodiments. One aspect of the invention includes the provision of a unique algorithm intended to monitor the usage of the compression system over time to estimate its effectiveness as a preventative or therapeutic medical device.

[0057] 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 provides compression to the patient's anatomy either directly through its features (e.g., inflation) or by providing attachment and positioning features for alternative compression means such as inflatable chambers or other devices. Each connected garment is sensed by a garment detection element 222, which enables the main system controller 210 to identify and configure the compression required for each connected garment based on the detected garment type.

[0058] Compression is provided by each garment 120 connected via a compression means 221 which provides and removes compression to the garment (e.g. by inflating areas of the garment using air pressure via an air source and vent valve arrangement, or by other means of applying a compression force directly to the patient's anatomy). This compression means 221 may be shared across multiple garments or may be independent for each garment.

[0059] The compression means 221 provides feedback to the main system microcontroller 210 on the degree of engagement with the anatomical structures and the effectiveness of the compression. As is well known, compression pressure within the inflatable garment is readily monitored by the main system microcontroller 210 using a pressure measurement element 230 (e.g., a pressure transducer). This allows for accurate and real-time control and delivery of compression to the garment 120, as well as detection of leaks and error conditions. Additional feedback from the compression means 221, such as other non-pressure measurements, can be used to ensure detection, accurate and consistent delivery of compression to the anatomical region.

[0060] 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 consisting of visual indicators such as an LCD display as shown in detail in FIG. 1 and FIG. 3a, 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. FIG. 3a shows an exemplary graphical user interface 117 of a compression system 100 known in the prior art in the form of an LCD panel with a full set of available graphic icons displayed. Only certain graphic icons are displayed at different times and in different operating modes. They provide an indication of the various functions and operating states of the compression system during different operating modes and at different times.

[0061] In operation and in one aspect of the invention, pressure is displayed (e.g., in convenient units such as mmHg) along with the detected garment being monitored for use. The displayed pressure is an indication of the delivered pressure to the garment and the patient's anatomy, with the range of pressure being associated with the connected garment type, identified by an identification component located within the garment connector. In one exemplary embodiment including a preferred target pressure for a first garment type intended for use on the legs, the target pressure is <65 mmHg, and the duration of application and the actual delivered pressure are monitored and recorded by the control system. In a further exemplary embodiment including a preferred target pressure for a second garment type intended for use on the feet, the target pressure is <140 mmHg, and the duration of application and the actual delivered pressure are monitored and recorded by the control system.

[0062] A timing element 240 may be provided, for example, in the form of a real-time clock (RTC) and is used to provide time-based information, such as timing periods, clock and calendar information, which may be stored in system memory 280 and used by operating software executing on the software main system controller.

[0063] A storage memory element 250 is provided that allows the main system microcontroller 210 to store data and records related to both periods of system use (i.e., intended and prescribed periods) as well as periods of non-use (i.e., operation or operation contrary to intended or prescribed). The storage memory element also includes timing information provided by the timing element 240. This allows for non-volatile storage of data related to typical periods of patient care (e.g., periods lasting hours and days) as well as data related 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 medical facility. In one aspect of the invention, the compression system memory 280 is appropriately sized to retain multiple activity records of use and non-use covering periods of at least three months to allow for quarterly based analysis and reporting. In a further embodiment, the storage memory 250 is sized to store multiple activity records of use and non-use covering periods of at least six months, allowing for additional data archiving and retrieval benefits.

[0064] 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).

[0065] 1, the fluid pressure control system 100 further includes a user interface, a display device 117. The display device 117 is operably connected to the controller. The display device 117 is configured to provide a user with an indication based on the garment's identity and / or an indication based on the usage status.

[0066] In one embodiment, the display device 117 is provided on the pump 110, i.e., the display device 117 is attached to the casing of the pump 110. In one embodiment, the display device may also be attached to the connection member 310, so that the user is provided with instructions regarding connection and use during the operation of the connection to the pump 110.

[0067] In one embodiment, a display device 117 is attached to the compression garment 120 to provide the user with an indication of the anatomical pressure points, the purpose of which is to indicate a usage signal and status once physically applied to the anatomical site, thereby visually influencing the removal process and encouraging increased usage.

[0068] In one embodiment, the display device 117 is a display unit such as an LCD display. In one embodiment, the LCD display uses a graphical icon associated with the type of connected garment as indicated by an identification component of each connected garment.

[0069] In one embodiment, the controller is provided on or in the pump 110. In another embodiment, the controller is provided on or in the garment 120.

[0070] As shown in FIG. 3a, a display device 117 in the form of a graphical LCD display is shown with a full range of icons associated with various different functions related to the compression system.

[0071] FIG. 3b highlights a particular icon in the panel shown in FIG. 3a that is used to display the usage state of the system when no garment is connected, i.e., before patient use. This element shows the display when the product is not being used for prophylaxis. The display shows that there is no connected garment currently detected as connected to the pump. The total past usage of the system can be shown in the lower right corner 118 of the display in the form of a multi-digit digital elapsed time meter that can be used to show a period in hours and minutes (e.g., 888 hours). The display also includes multiple graphic icons in the exemplary limb 117b section for each compression output of the compression system.

[0072] FIG. 3c shows an exemplary display of the compression system when the system detects the connection of two garments available for monitoring, intended for connection to the patient's legs, specifically the calves. A set of icons of the connected garments is visually displayed in 117c, and usage information is displayed in the form of a multi-digit digital elapsed time meter in the lower right corner 118 of the display, which is associated with total and continued usage of the compression system, and optionally with the type of garment connected. FIG. 3c shows only those icons of FIG. 3a that are relevant for displaying the first display state 117a, 117c associated with monitoring usage by the patient. This includes icons associated with anatomical structures such as the limbs with the feet, legs and calves, various garment icons attached to the limb regions, and a timing display 118 including a multi-digit seven-segment numeric display. The nature of the garment icons displayed depends on those 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 on the timing display is associated with the monitored usage of the connected garments.

[0073] Figure 3d shows an example of a second status indicator 117d for a compression system operating with the same connected calf garment detailed in Figure 3c, but without the patient's limb present. The usage information displayed in the lower right corner 118 of the indicator 117 can be in the form of a multi-digit elapsed time meter, with the timing information being changed to correlate with the non-use of the garments. This monitored timing information is initially displayed in minutes, and then in hours and minutes depending on the monitored elapsed time value.

[0074] The indicated condition is associated with a condition in which the patient's limb is sensed to be absent and the compression system is not providing the intended treatment or prophylaxis. The timing information displayed on the timing display is associated with a monitored lack of use of the connected garment.

[0075] Figure 4 illustrates pictorially one example of a typical usage scenario of the compression system of Figure 1 by a patient, graphically illustrating periods of use and non-use and the effect on first and second display states provided by the user display.

[0076] This use scenario includes individual periods of use A, C, E interspersed with periods of non-use B, D. These periods can 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 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.

[0077] 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 includes when clothing is physically removed from a patient's limb for examination and then the caregiver neglects to replace the clothing. In this scenario, the patient is not receiving the prescribed treatment and is therefore at risk. This aspect is specifically monitored by the present invention.

[0078] The timing is described accordingly: a first use state A lasts from time T0 to time T1, the period being T1-T0, and the LCD display provides a first display state with an increasing timing value between T0 and T1.

[0079] 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 state is visible, and a final use period E during which the first display is active.

[0080] 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.

[0081] 4, an example of the present invention of a compression system is shown with two defined states of use. The first state of use is associated with intended normal operation by the patient and the second state of use is associated with operation of the system in an unintended mode that results in a lack of prophylaxis being administered. The system is capable of monitoring and interpreting the results of these states over multiple separate episodes.

[0082] Several separate 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 delivered 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.

[0083] Figure 5 is a flow chart detailing an exemplary embodiment of the present invention that allows the monitoring system to determine which indications to provide to the compression system as a result of the monitoring system. In Figure 5, the system is able to monitor each connected garment, control its inflation in real time, and detect the presence of a limb within each compression garment during each inflation. This is achieved by analysis of measurements and multiple parameters taken at various times during the inflation process. These measurements include the pressure in the connected tube, the pressure in the connected inflated garment, the type of connected garment, the compressor parameters required for each connected garment type, and signals related to the compression means (compressor drive waveform amplitude, applied drive waveform frequency, current, voltage, etc.).

[0084] A measure of preventative 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 significant differences between those two analysis points and uses the differences to determine the effectiveness of compression.

[0085] 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. This indication change may occur with operation of only a single connected garment or with operation of two connected garments. The indication change may occur when either one of two connected garments is detected as not being used with the patient's limb.

[0086] A further embodiment involves the use of a proprietary algorithm, shown diagrammatically in Figure 6, via a generic algorithm structure that can be used to provide the usage monitoring function of the compression system. Each parameter is calculated by the compression system and individual parameter weightings are provided and applied as inputs to the algorithm.

[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] The output of the algorithm is displayed and correlated with the results of interpretations of the use and non-use of the compression system for an individual patient. Some illustrative output examples are described below. - A patient-specific compliance score 610 based on an individual patient's monitored usage. This can be in the form of a percentage or ratio of time of use to time of non-use, calculated over a defined period of time. - Patient Compliance History 620. This includes multiple individual measures of usage over time, such as daily scores indicating compliance with required protocols. - System utilization data 630, which indicates utilization of the compression system, such as how long the compression pump is in use over time compared to when the compression pump is not in use. - A system-specific compliance score 640, which indicates how the compression system was used compared to target utilization against established thresholds or goals.

[0089] When the compression system detects that it is not delivering prophylaxis to the patient, it can adapt its instructions to the user. User instructions can include LCD-based instructions, LED-based instructions, and audio instructions from the pump. Thus, the level of instructions can be adapted as needed in the clinical setting. This can include graduated and progressive instructions that are proportional to or related to the duration of the usage event. Thus, when the period of lack of use is short, a low level of instructions or priority can be provided to the user, but this can become stronger as the period becomes longer and the conditions related to the lack of use become more critical.

[0090] In a preferred embodiment, a flashing green LED indication is provided at multiple locations on the compression system, similar to the first and second indications, if a duration of 10 compression cycles is detected without proper prophylaxis being delivered. The use of multiple LED indications on the compression system allows for visibility from multiple directions, thereby allowing clinical staff to easily determine the status of the compression system and its use from various directions without having to approach or operate the compression system.

[0091] 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, 20 cycles.

[0092] 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.

[0093] The compression system may optionally include a means for communicating its status and data 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 or more compression systems. This communication means may utilize wireless technology (Bluetooth, ZigBee, Wi-Fi, etc.) and / or a dedicated wired connection to another device that may display the information itself or provide onward communication, such as another medical device, such as a hospital bed or support surface pump.

[0094] FIG. 7 illustrates the operation of the usage monitoring feature of the compression system and how it works when the system is used effectively over an extended period of time and usage exceeds a set or calculated threshold or target value. The detected usage is shown as an increment plotted against the y-axis and the monitored usage time (in hours), including only a short period t1-t2 where no usage occurs. The required target threshold (shown in dashed lines) is shown to be increasing over time. As usage is above the target value, usage of the compression system is considered to be sufficient and appropriate positive messages and feedback are provided to the user. A score is calculated from the algorithm and this score can be recorded against a target indicating a satisfactory situation.

[0095] FIG. 8 illustrates the operation of the compression system usage monitoring function when the system is not being used effectively as shown in FIG. 7, for example due to a long period of non-use t1-T3. As a result, usage is below a set or calculated threshold or target value. As usage is below the target value, usage of the compression system is considered to be insufficient and appropriate negative messages and feedback are provided to the user. A score is calculated from the algorithm and this score can be recorded against the target indicating an unsatisfactory situation.

[0096] A further aspect of the invention includes analyzing compression system usage data to determine whether a calculated threshold associated with a selected compression regime, such as the CHEST guidelines published by the American College of Chest Surgeons, recommends the use of mechanical prophylaxis for at least 18 hours every 24 hours.

[0097] In one embodiment, a control unit or controller is provided for controlling compression therapy to a patient's limb or anatomical structure using at least one inflatable compression garment including at least one inflatable chamber, the control unit comprising means for detecting the type of compression garment connected using measurement of an identification component disposed as part of the connector of the compression garment, the identification component being made of a ferrite, steel or brass material.

[0098] The compression system is - a connector / outlet port of the compression system in fluid communication with at least one garment, the outlet port being capable of detecting which garment type is connected among a plurality of possible garment types; an air pump for supplying and regulating air pressure to the compression garment based on the detected type, the manner in which the compression is delivered being dependent on the identification components sensed from the connected garment; and at least one pressure sensor for measuring pressure present in at least one of the inflatable chambers of the connected garment during compression therapy and for generating a signal corresponding to the pressure in the chamber; - the pressure sensor provides a signal during application of compression, the signal including a feature indicative of the presence of a limb or anatomical structure within at least one compression garment; - the pressure sensor indicates that the limb or anatomical structure has been removed from the compression garment resulting in a change in the compression garment's level of compression compared to its previous inflation characteristics; A visual indication is provided to the user by the control unit based on the monitored time when the limb or anatomical structure is present within the connected garment compared to the monitored time when the limb is detected not to be present within the connected garment.

[0099] In one embodiment, a control unit is provided for controlling compression therapy to a patient's limb or anatomical structure using at least one inflatable compression garment, the control unit configured to correlate measurements obtained from a pressure transducer connected to a pump outlet with a type of connected compression garment to form a detectable signature related to the presence of a limb or anatomical structure surrounded by the at least one inflatable compression garment.

[0100] In one aspect, a control unit is provided for controlling and monitoring the operation and delivery of prophylactic impulses to a patient's limb or anatomical structure, the control unit measuring a parameter forming a detectable characteristic of the presence of the limb or anatomical structure in contact with the compression garment.

[0101] In one embodiment, a control unit is provided for controlling and monitoring the operation and delivery of compression therapy using at least one inflatable garment. The control unit is in electronic communication with a separate remote sensor attached to the patient. The sensor measures patient-specific parameters and determines among the following characteristics: the control unit carrying out an analysis of one or more signals received from the sensor; the control unit detecting correlations between changes in the patient sensor and operation of the control unit, such that changes in blood movement within the anatomical structure are detected as a result of operation of the control unit; the control unit providing an indication to a user that communication with the remote sensor has been established; - the control unit monitors the patient's usage of the garment over time based on signals of the remote sensor; Includes at least one of the following.

[0102] In one embodiment, the patient-specific parameter is related to the circulatory status of a patient connected to a remote sensor.

[0103] In one aspect, the sensed parameter is related to a measured change in blood flow within a patient anatomy connected to a remote sensor.

[0104] In one embodiment, changes in circulation of the patient's anatomy are linked to operation of the control unit.

[0105] In one embodiment, sensing is performed by the control unit only during compression of the limb.

[0106] In one embodiment, the detectable patient characteristics include at least two measurable parameters of the type of garment connected, the detected tightness of the garment against the limb, the measured volume of the garment, the temperature of the limb, the detectable arterial pulsation of the limb, the pressure response to a pressure impulse applied within the garment, the rate of chamber pressure rise during inflation, the change in pressure during compression, the rate of chamber pressure fall during deflation, compressor settings, and patient parameters communicated from an external device.

[0107] In one embodiment, the presence of an extremity within a garment is defined and confirmed by a combination of at least two different measured parameters.

[0108] In one embodiment, a visual indication is displayed on the control unit indicating the presence of the patient's extremity in at least one of the connected garments.

[0109] In one embodiment, a visual indication is shown on the control unit indicating that a detected extremity is absent or detached on at least one of the connected garments.

[0110] In one aspect, the visual indication is in the form of a graphical extremity image.

[0111] In one aspect, an indication of the presence of an extremity within the garment is also remotely provided to another monitoring device located remotely from the control unit.

[0112] In one aspect, the inflatable chamber of the garment is located at the most distal position of multiple inflatable chambers within the garment.

[0113] In some embodiments, the values ​​of the measured parameters vary between different garment types.

[0114] In some embodiments, the value of the measured parameter depends on the presence of clothing on the limb.

[0115] In one embodiment, the value of the measured parameter depends on the effect of the garment on the compressed limb.

[0116] In one embodiment, the value of the measured parameter is correlated with the detected connected garment type, thereby providing confirmation of the presence of the limb in a particular connected garment type.

[0117] In one aspect, the air temperature measured within the connected garment will be higher when an extremity is present within the garment compared to the air temperature within the garment without the extremity present.

[0118] In some aspects, the applied treatment parameters are altered in response to the measured parameters.

[0119] In one embodiment, the pressure level applied to the garment is altered as a result of the measured parameter.

[0120] In some embodiments, the cycle time of the garment is altered as a result of the measured parameters.

[0121] In one aspect, the inflation time of the garment is altered as a result of the measured parameters.

[0122] In one embodiment, movements associated with the limbs present in at least one of the garments are recorded in a memory, such as a digital memory.

[0123] In one embodiment, the duration of the movement is recorded in digital memory.

[0124] In one embodiment, the date and time of limb detection is recorded in memory.

[0125] In one embodiment, the duration of a movement associated with a limb present in at least one of the garments is recorded.

[0126] In one embodiment, the dates and times when no limbs were detected are stored in memory.

[0127] In one aspect, the control unit may record the duration of time when it is not in use.

[0128] In some aspects, the control unit is capable of recording the dates and times when the control unit is not in use by the patient.

[0129] In one embodiment, the data is paired to construct start / stop patient episodes for usage detection, monitoring and analysis.

[0130] In one aspect, the control unit combines the start and stop of limb detection via data pairing to form a record of a patient use episode corresponding to use of the control unit.

[0131] In one aspect, when there are gaps between episodes of patient use, the control unit combines stopping and starting limb detection via data pairing to form episodes of non-use corresponding to times when there is no use of the control unit by the patient.

[0132] In some aspects, details of paired episodes are recorded in a memory, such as a digital memory.

[0133] In one embodiment, the contents of the digital memory associated with each episode of limb detection in at least one garment can be communicated to an external device.

[0134] In one embodiment, the contents of the digital memory associated with each episode of limb detection in at least one garment are displayed on the control unit.

[0135] In one embodiment, a control unit is provided for providing monitoring of the cumulative duration of detected limb detection episodes when an indication of sufficient / insufficient prophylaxis is made against a defined target threshold.

[0136] In one aspect, an indication is provided to the user when the cumulative duration of limb detection episodes exceeds a goal threshold over a defined elapsed period.

[0137] In one aspect, an indication is provided to the user when the cumulative duration of limb detection episodes falls below a target threshold for a defined elapsed period.

[0138] In one aspect, a control unit is provided in which a particular progress indicator is provided, the monitored duration being displayed as a percentage of a target threshold.

[0139] In one aspect, the duration is indicated as a visual portion of a graphic icon representing the target threshold.

[0140] In one aspect, if the usage conditions are changing, a trend indication indicator is calculated that indicates either improving or worsening usage. A control unit is provided that provides a trend indication to a user if the monitored usage conditions are changing over time. The monitored usage conditions correspond to a threshold value, the threshold value being defined by an identification component associated with the garment detector.

[0141] In one aspect, an indication is provided to the user when monitored usage is decreasing over time.

[0142] In one aspect, an indication is provided to the user when monitored usage is increasing over time.

[0143] In one aspect, a target threshold is provided, the target threshold being user adjustable at the control unit.

[0144] In one aspect, the target threshold is associated with a defined elapsed time.

[0145] In one aspect, the defined period of elapsed time is user adjustable in the control unit.

[0146] In one aspect, target thresholds are provided and associated with each connected garment type, the target thresholds being associated with the particular garment type attached to the control unit, and the target thresholds being stored in the control unit.

[0147] In some aspects it may be necessary or beneficial to set different targets based on the patient's needs. A control unit is provided, where target thresholds stored in the control unit are updated by measurements of parameters from connected garment types.

[0148] In some aspects, the target thresholds may be adjustable by the user as required based on the clinical condition of a particular patient.

[0149] In some aspects, the user can select the desired target threshold value from among a number of pre-set values.

[0150] In some aspects, the user may select the desired target thresholds based on the clinical policy of the individual medical facility using the control unit.

[0151] In one embodiment, the control unit monitors the clinical requirements of the CHEST guidelines, with a required target threshold of 18 hours of use every 24 hours.

[0152] In one aspect, an adaptive threshold based on detected usage is added, and if the system monitors usage that is less than the required threshold, the threshold is adjusted and increased for the next period of usage. A control unit is provided that features a target threshold that automatically changes based on monitored usage during a monitoring period.

[0153] In one embodiment, a risk value is calculated using known clinical assessment methods, such as Caprini, Padua, Rogers, Potter, and the risk value is used as a basis for selecting a threshold value. A control unit is provided that allows a user to adjust the threshold value of use based on a clinically accepted risk scoring system.

[0154] In one embodiment, the individual target thresholds equate to a risk scoring system with multiple levels of selectable thresholds.

[0155] In one embodiment, a communication link to the patient record is added (to report on compliance with thresholds and also allow for threshold setting).

[0156] A control unit is provided whereby data regarding compliance with goals / thresholds and individual patient usage episodes is transmitted electronically and stored in the patient's electronic medical record. Examples of electronic communication include the use of wireless means such as Bluetooth, WiFi, Zigbee, or a wired connection such as USB.

[0157] In one aspect, the control unit can receive the target thresholds from the patient's electronic medical record via electronic communication, and the operation of the compression system can be adapted to indicate or otherwise recommend predetermined usage targets based on a clinical prescription, which targets are translated into usage thresholds associated with each garment type as identified by the garment identification component.

[0158] In some aspects, the compression system includes the ability to adaptively modify or otherwise change target thresholds based on time or temporal data such as elapsed time (e.g., different thresholds can be employed based on time of day to compensate for large differences in usage such as between nighttime sleep and daytime clinical activity). A control unit is provided in which the required thresholds are automatically modified depending on the time of day to provide varying thresholds.

[0159] In a further aspect, different thresholds can be used depending on the duration of monitored use, for example, target thresholds that are higher at the beginning of a patient's use, such as before surgery or during an initial hospital stay, and then gradually lowered as the patient recovers and mobilizes.

[0160] In one aspect, a fluid pressure control system or compression system is provided that includes a pump, at least one inflatable / deflatable article, such as a compression garment, a display device, such as a user display, and a monitoring system or control unit for detecting usage of the at least one compression garment. The user display includes a first display indicator associated with a first state of operation of the compression system, e.g., use of the compression garment in a first prophylactic state or a first operating state. The user display includes a second display indicator associated with a second state of operation of the compression system, e.g., use of the garment in a second non-prophylactic state or a second operating state.

[0161] In one embodiment, a first operating state is associated with the presence of a patient's extremity within the garment and a second operating state is associated with the absence of a patient's extremity within the compression garment.

[0162] In one aspect, the monitoring system is configured to monitor when the compression garment is in each of the operating conditions.

[0163] In one embodiment, the first operating state is a state in which the prophylaxis is administered and the second operating state is a state in which the prophylaxis is not administered.

[0164] In some applications, the monitoring system is configured to monitor the effectiveness of delivery of prophylaxis to the compression garment.

[0165] In one embodiment, the presence of the connected garment and the patient's extremity is monitored over time by a monitoring system to provide an indication of system usage.

[0166] In one aspect, a metric formed from usage times over monitored time is compared to a target usage threshold.

[0167] In one aspect, the compression system includes a remotely located patient sensor that is coupled to the patient's anatomy and in electronic communication with a control unit for control and monitoring of compression to the patient.

[0168] In one aspect, a compression system is provided comprising and includes the aforementioned means and methods for detecting usage of at least one compression garment of the compression system, the compression system including a user display, the user display including a first display indicator associated with usage of the compression garment in a first operating state of the compression system, and a second display indicator associated with usage of the garment in a second operating state of the compression system.

[0169] In one embodiment, the compression system has a first operating state associated with the presence of a patient's extremity within the compression garment and a second operating state associated with the absence of the patient's extremity within the compression garment.

[0170] In a related aspect, the method includes monitoring when the compression garment is in each operating state.

[0171] In one embodiment, the first operating state is a prophylactic state and the second operating state is a non-prophylactic state.

[0172] In some aspects, the methods include monitoring the effectiveness of the prophylaxis provided.

[0173] In one aspect, the method includes monitoring the presence of the connected garment and the patient's extremity over time with a monitoring system to provide an indication of system usage.

[0174] In one aspect, the method includes comparing the monitored usage over time to a target usage threshold.

[0175] 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.

[0176] 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.

[0177] 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. 1. A control unit (200) for analyzing the application of compression therapy to a patient's limb or anatomical structure using at least one inflatable compression garment (120) including at least one inflatable chamber, comprising: The control unit (200) an identification component (390) for detecting the type of at least one compression garment (120) used during compression therapy and placed within the connector of said at least one compression garment; an air pump (110) for adjusting the air pressure to said at least one compression garment (120) based on the detected type; at least one pressure sensor for measuring the pressure present in at least one inflatable chamber of at least one connected compression garment (120) during compression therapy and generating a signal corresponding to the pressure in said chamber; the pressure sensor provides a signal during application of compression, the signal including a feature indicative of the presence of a limb or anatomical structure within the at least one compression garment (120); the pressure sensor indicates that a compression level of the at least one compression garment (120) has changed as a result of a limb or anatomical structure being removed from the at least one compression garment (120) compared to a signal characteristic during a previous compression; a visual indication (117a, 117c, 118) is provided to the user by the system (100) based on the monitored time when the limb or anatomical structure was present within the at least one connected garment (120); and a control unit, wherein a visual indication (117b, 117d, 118) is provided by the system to the user based on the monitored time when the absence of a limb or anatomical structure is detected within said at least one connected garment (120).

2. 2. The control unit according to claim 1, 10. A control unit configured to correlate measurements obtained from a pressure transducer connected to the pump outlet with the type of compression garment connected to form a detectable signature associated with the presence of a limb or anatomical structure surrounded by the at least one inflatable compression garment (120).

3. 2. The control unit according to claim 1, The control unit - monitoring the operation and delivery of prophylactic impulses to the patient's limbs or anatomical structures; a control unit, characterized in that it is adapted to measure parameters forming a detectable characteristic of the presence of a limb or anatomical structure in contact with the compression garment.

4. 2. The control unit according to claim 1, The control unit is in electronic communication with a separate remote sensor attached to the patient, the sensor configured to measure a patient-specific parameter, and has one of the following features: said control unit carrying out an analysis of one or more signals received from said sensors; - the control unit detecting correlations between changes in the patient's sensors and operation of the control unit, such that changes in blood movement within the anatomical structure are detected as a result of operation of the control unit; - the control unit providing an indication to a user that communication with the remote sensor has been established; - said control unit monitors the use of the garment by the patient over time based on signals from said remote sensors; A control unit comprising at least one of the following:

5. The control unit according to any one of claims 1 to 4, A control unit characterized in that the identification component (390) is made of ferrite, steel or brass material.

6. A compression system (120) for analyzing the use of compression therapy using at least one compression garment (120), comprising: A user interface (117), the user interface (117) comprising: a first display indicator (117a, 117c) associated with the usage of the at least one compression garment (120) when the compression system (100) is in a first operating state; and a second display indicator (117b, 117d) associated with the usage status of the at least one compression garment (120) when the compression system (100) is in a second operating state.

7. 7. The system of claim 6, 1. A system comprising: a control unit configured to monitor the operation and delivery of prophylactic impulses to a patient's limb or anatomical structure and to measure compression parameters forming a detectable signature of the presence of a limb or anatomical structure in contact with said compression garment.

8. 8. The compression system of claim 7, A compression system wherein said compression parameters are adaptive and changeable depending on the extent of previous use based on records maintained in a memory storage device.

9. 9. The compression system of claim 8, A compression system, wherein the alterable compression parameters are based on a sensed identification component (390) in the garment connector (330).

10. 10. The compression system of claim 8 or 9, A compression system in which compression pressure is adjusted based on an analysis of a record of previous use of the compression system stored in a storage memory (250) of the compression system.

11. 10. The compression system of claim 8 or 9, A compression system, wherein the cycle time of the compression system is adjusted based on an analysis of a record of previous usage of the compression system stored in a storage memory (250) of the compression system.

12. The compression system according to any one of claims 1 to 4 and 6 to 9, A compression system, characterized in that the detection of the presence of a limb within said at least one compression garment (120) occurs only during inflation of said at least one compression garment (120).

13. The compression system according to any one of claims 1 to 4 and 6 to 9, 1. A compression system, wherein the detection of the presence of a limb is based on at least one parameter from the list consisting of a pressure transducer, a compressor drive parameter, a garment connector type, an identification component type, or an analysis of a record of previous use of the compression system stored in a storage memory (250) of the compression system.

14. A compression system (100), comprising: a connector (310) of the compression system in fluid communication with at least one compression garment (120), the connector being capable of detecting which garment type is connected among a plurality of possible garment types; an air pump (110) for supplying and adjusting the air pressure to said at least one compression garment (120) based on the type detected; - at least one pressure sensor for measuring the pressure present in at least one inflatable chamber of at least one connected compression garment (120) during compression therapy and for generating a signal corresponding to the pressure in said at least one inflatable chamber; - said pressure sensor provides, during compression, a signal comprising a feature indicative of the presence of a limb or anatomical structure within said at least one compression garment (120); - said pressure sensor indicates that the compression level of said at least one compression garment (120) has changed compared to its previous inflation characteristics as a result of a limb or anatomical structure being removed from said at least one compression garment (120); - A compression system characterized in that a visual indication is provided to a user by a control unit (200) of the compression system (100) based on the monitored time when a limb or anatomical structure is present within the at least one connected garment (120) compared to the monitored time when no limb is detected within the at least one connected garment (120).

15. 1. A method for analyzing compression therapy usage using at least one compression garment (120) of a compression system (100) having a user interface (117), the method comprising: - a first display indicator (117a, 117c) associated with the use of the compression garment when said compression system is in a first operating state; - second display indicators (117b, 117d) associated with the use of the compression garment when the compression system is in a second operating state, the method comprising the step of monitoring the time the compression garment is in each operating state.

16. 16. The method of claim 15, The method further comprising the step of monitoring the effectiveness of the prophylaxis provided.

17. 16. The method of claim 15, monitoring, via a monitoring system of the compression system (100), the presence of at least one connected compression garment (120) and the patient's limb over time to provide an indication of system usage.

18. 16. The method of claim 15, A method comprising comparing usage conditions over a monitoring period to a target usage threshold.

Images