Systems devices and methods for combined compression and negative pressure therapy

Abstract

Provided herein are systems and devices for providing a combined compression and negative pressure therapy. Further provided are methods of using the systems and methods for applying a combined compression and negative pressure therapy to a body part of a subject in need thereof.

Description

[0001] SYSTEMS DEVICES AND METHODS FOR COMBINED COMPRESSION AND NEGATIVE PRESSURE THERAPY

[0002] FIELD OF THE INVENTION

[0003] Disclosed herein are systems, devices and methods for providing a combined compression and negative pressure therapy.

[0004] BACKGROUND

[0005] Compression therapy is used to apply controlled pressure to body parts, for example, to improve blood flow, prevent or reduce blood clots formation, and the like. Compression therapy may be applied, for example, by utilizing pneumatic compression therapy. This form of treatment is performed using a compression device, which feeds compressed air to a garment or sleeve containing one or more cells which inflate and deflate, alternately applying and releasing pressure to the extremities of the patient.

[0006] Negative pressure therapy (Vacuum therapy) creates suction and negative pressure by mechanical means and is used to stretch the skin and the tissue underneath, loosen adhesions and lift connective tissues creating more space for blood and Lymph flow. The vacuum technique produces a “separation” in tissue layers enabling water absorption and renewed blood flow to the tissue.

[0007] Both the compression and negative pressure therapy are used for helping to move excess fluid from an impaired body part to healthy regions of the body, where fluid can be absorbed and processed naturally by the body. This operation helps to treat medical conditions of Lymphedema (Primary and Secondary), Chronic venous insufficiency, Venous stasis ulcers, Edema (Post mastectomy edema, Edema following trauma and sports issues etc.), Lipedema, Reduction of wound healing time, Reduction of pain and swelling after injury and surgery and the like.

[0008] Although patients benefit from combining both compression and negative pressure therapy, each treatment is provided separately using a separate dedicated device. This fact brings to a cumbersome use of two devices which takes up a lot of space and causes high costs. There is therefore a need in the art to combine both the compression therapy and negative pressure therapy to be provided by a single system and / or device, in a manner that is efficient, saves space and is cost effective.

[0009] SUMMARY

[0010] Aspects of the invention, in some embodiments thereof, relate to systems, devices and methods for providing a combined compression and negative pressure therapy.

[0011] According to some embodiments, presented herein are systems combining three functions of: compression therapy, negative pressure decompressing an attached compression sleeve and negative pressure (vacuum) therapy.

[0012] Advantageously, according to some embodiments, all three functions share the same compression pump (or pumps), same control unit (processing circuitry / processor) and same air electric valves (solenoid valves) making the system cost efficient and compact in size.

[0013] According to some embodiments, the system includes one or more compression pumps with positive and negative air outlets.

[0014] According to some embodiments, the system includes internal air valves configured to direct negative pressure created by the one or more compression pumps towards an air hose connecting an external application unit used for negative pressure.

[0015] Advantageously, according to some embodiments, the disclosed air valves configuration allows using minimal number of pumps, valves and air paths, yet providing the unique features of:

[0016] Compression therapy, using positive pressure compressing an attached compression sleeve .

[0017] - Decompression of the attached compression sleeve using negative pressure generated from the pumps (active deflation).

[0018] - Negative pressure treatment using an attached negative pressure applicator.

[0019] Series of air valves connected to the compression sleeve, allowing compression and decompression of the compression sleeve using one air connection from each valve to the compression sleeve. According to some embodiments, there is provided a system for combined compression and negative pressure therapy. The system comprises: one or more compression pumps comprising positive and negative air outlets, connected to one or more positive pressure and one or more negative pressure air pipes; a detachable compression sleeve configured to inflate and deflate, thereby providing compression therapy, when placed on a body portion of a subject; a connectable negative pressure applicator configured for providing a negative pressure therapy; three or more internal air valves, each valve with three outlets and two operation states, configured to direct negative pressure created by the one or more pumps through at least one of the negative pressure air pipes connecting the negative pressure applicator, thereby allowing negative pressure therapy, or towards the compression sleeve to thereby allow deflation of the connectable compression sleeve; one or more inflation air valves configured to direct positive pressure created by the one or more compression pumps through the one or more positive pressure air pipes to the compression sleeve to thereby allow inflation of the connectable compression sleeve; and a processing circuitry configured to: receive a user-selection therapy, selected from: a negative pressure therapy, or inflation, passive deflation or active deflation of the compression sleeve as part of the compression therapy; and control powering on and off the one or more compression pumps, each of the one or more inflation air valves and each one of the first, second and third internal air valves, to provide said user-selection therapy.

[0020] According to some embodiments, the system further comprises a negative pressure sensor.

[0021] According to some embodiments, for negative pressure therapy, the processing circuitry is configured to power on the first and second internal air valves and the one or more compression pumps and after the negative pressure sensor reads a pressure that is lower than a first predefined threshold, the processing circuitry is configured to power off the one or more compression pumps. According to some embodiments, the system further comprises a positive pressure sensor.

[0022] According to some embodiments, for inflation of the attached compression sleeve, the processing circuitry is configured to power on one inflation air valve and after the positive pressure sensor reads a pressure that is higher than a second threshold, or alternatively the processing circuitry is configured to power on one or more subsequent inflation air valves according to a predetermined inflation sequence.

[0023] According to some embodiments, for inflation of the attached compression sleeve, the processing circuitry is configured to power on the one or more inflation air valves according to a predetermined inflation sequence.

[0024] According to some embodiments, for passive deflation of the attached compression sleeve, the processing circuitry is configured to power off the one or more compression pumps, all of the three or more internal air valves and all of the one or more inflation air valves.

[0025] According to some embodiments, for active deflation of the attached compression sleeve, the processing circuitry is configured to power on the first and third internal air valves and the one or more compression pumps, and after given period of time, the processing circuitry is configured to power off the one or more compression pumps.

[0026] According to some embodiments, the system further comprises an additional negative pressure sensor wherein for active deflation of the attached compression sleeve, the processing circuitry is configured to power on the one or more inflation air valves, the first and third internal air valves and the one or more compression pumps, and after the additional negative pressure sensor reads a pressure that is lower than a third predefined threshold, the processing circuitry is configured to power off the one or more compression pumps.

[0027] According to some embodiments, the negative pressure therapy and the compression therapy are used to treat or at least partially ameliorate symptoms associated with one or more of the following medical conditions: Primary Lymphedema and Secondary Lymphedema, chronic venous insufficiency, venous stasis ulcers, Edema, Lipedema, reduction of wound healing time, reduction of pain and / or swelling after injuries and surgeries, and the like, or any combinations thereof. Each possibility is a separate embodiment.

[0028] According to some embodiments, the attached compression sleeve comprises one or more bladders, configured to inflate or deflate, to thereby provide compression therapy.

[0029] According to some embodiments, the body part comprises a limb.

[0030] According to some embodiments, the system is configured for home use.

[0031] According to some embodiments, the system is configured for use in a careproviding facility.

[0032] According to some embodiments, the system is configured to be operated by a nonprofessional operator or a professional care giver.

[0033] According to some embodiments, there is provided a method for a combined compression and negative pressure therapy, using the system and / or device disclosed herein. The method may include the steps of: receiving a user-selection therapy, selected from: a negative pressure therapy, and a compression therapy comprising inflation and deflation of a compression sleeve; and controlling, by the processing circuitry, powering on and off the one or more compression pumps, each of the one or more inflation air valves and each one of the internal air valves, providing one of said user-selection therapy.

[0034] According to some embodiments, for negative pressure therapy, the method comprises powering on the first and second internal air valves and the one or more compression pumps and after a negative pressure sensor reads a pressure that is lower than a first predefined threshold, powering off the one or more compression pumps.

[0035] According to some embodiments, for inflation of the compression sleeve, the method comprises powering on one inflation air valves and after a positive pressure sensor reads a pressure that is higher than a second threshold, powering on one or more subsequent inflation air valves according to a predetermined inflation sequence. According to some embodiments, for inflation of the compression sleeve, the method comprises powering on the one or more inflation air valves according to a predetermined inflation sequence.

[0036] According to some embodiments, for passive deflation, the method comprises powering off the one or more compression pumps, all of the three or more internal air valves and all of the one or more inflation air valves.

[0037] According to some embodiments, for active deflation, the method comprises powering on the one or more inflation air valves, the first and third internal air valves and the one or more compression pumps, and after a positive pressure sensor reads a pressure that is lower than a third predefined threshold, powering off the one or more compression pumps.

[0038] According to some embodiments, there is provided a device for combined compression and negative pressure therapy. The device comprises: one or more compression pumps comprising positive and negative air outlets, connected to one or more positive pressure and one or more negative pressure air pipes; three or more internal air valves configured to direct negative pressure created by the one or more pumps through at least one of the negative pressure air pipes, which are configured to connect to a negative pressure applicator, thereby allowing negative pressure therapy, or towards a connectable compression sleeve to thereby allow deflation of the connectable compression sleeve; one or more inflation air valves configured to direct positive pressure created by the one or more compression pumps through the one or more positive pressure air pipes configured to connect to a connectable compression sleeve to thereby allow inflation of the connectable compression sleeve; and a processing circuitry configured to: receive a user-selection therapy, selected from: a negative pressure therapy, or inflation, passive deflation or active deflation of the compression sleeve as part of the compression therapy; and control powering on and off the one or more compression pumps, each of the one or more inflation air valves and each one of the three or more internal air valves, to provide said user-selection therapy.

[0039] According to some embodiments, the systems and methods disclosed herein may be used for applying compression and / or negative pressure, to thereby provide therapy to a subject in need thereof.

[0040] Certain embodiments of the present invention may include some, all, or none of the above advantages. Further advantages may be readily apparent to those skilled in the art from the figures, descriptions, and claims included herein. Aspects and embodiments of the invention are further described in the specification hereinbelow and in the appended claims.

[0041] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. In case of conflict, the patent specification, including definitions, governs. As used herein, the indefinite articles “a” and “an” mean “at least one” or “one or more” unless the context clearly dictates otherwise.

[0042] BRIEF DESCRIPTION OF THE FIGURES

[0043] Some embodiments of the invention are described herein with reference to the accompanying figures. The description, together with the figures, makes apparent to a person having ordinary skill in the art how some embodiments may be practiced. The figures are for the purpose of illustrative description and no attempt is made to show structural details of an embodiment in more detail than is necessary for a fundamental understanding of the invention. For the sake of clarity, some objects depicted in the figures are not to scale.

[0044] In the Figures:

[0045] FIG. 1 schematically shows a diagram of a system for combined compression and negative pressure therapy, according to some embodiments;

[0046] FIG. 2 schematically shows a flow chart of a method for combined compression and negative pressure therapy, according to some embodiments; FIG. 3A schematically shows a flow chart of a method for providing a negative pressure therapy treatment, using the system presented in FIG. 1, according to some;

[0047] FIG. 3B schematically shows a flow chart of a method for providing inflation as part of the compression therapy using the system presented in FIG. 1, according to some embodiments;

[0048] FIG. 3C schematically shows a flow chart of a method for providing passive deflation as part of the compression therapy using the system presented in FIG. 1, according to some embodiments;

[0049] FIG. 3D schematically shows a flow chart of a method for providing active deflation as part of the compression therapy using the system presented in FIG. 1, according to some embodiments;

[0050] FIG. 4A schematically shows an example of a device 400 for combined compression and negative pressure therapy, according to some embodiments;

[0051] FIG. 4B schematically shows device 400 of FIG. 4A connected to a detachable compression sleeve 405 and connected to a negative pressure applicator 406, according to some embodiments;

[0052] FIG. 5A schematically shows an example of a Sequential inflation cycle, according to some embodiments; and

[0053] FIG. 5B schematically shows an example of a Peristaltic (wave form) inflation cycle, according to some embodiments.

[0054] DETAILED DESCRIPTION

[0055] The principles, uses and implementations of the teachings herein may be better understood with reference to the accompanying description and figures. Upon perusal of the description and figures present herein, one skilled in the art will be able to implement the teachings herein without undue effort or experimentation. In the figures, same reference numerals refer to same parts throughout. In the description and claims of the application, each of the words “comprise” “include” and “have,” and forms thereof, are not necessarily limited to members in a list with which the words may be associated.

[0056] As used herein, the term "subject" and "patient" may interchangeably be used.

[0057] As used herein, the term "health care provider", "user", "physician" relate to a provider of therapy to a subject in need thereof.

[0058] As used herein, the term “about” is used to specify a value of a quantity or parameter (e.g., the length of an element) to within a continuous range of values in the neighbourhood of (and including) a given (stated) value. According to some embodiments, “about” specifies the value of a parameter to be between 80 % and 120 % of the given value. For example, the statement “the length of the element is equal to about 1 m” is equivalent to the statement “the length of the element is between 0.8 m and 1.2 m”. According to some embodiments, “about” specifies the value of a parameter to be between 90 % and 110 % of the given value . According to some embodiments, “about” specifies the value of a parameter to be between 95 % and 105 % of the given value.

[0059] According to some embodiments, there are provided advantageous device, system and method for a combined compression and negative pressure therapy. The system and the device include one or more compression pumps including positive and negative air outlets, connected to one or more positive pressure and one or more negative pressure air pipes. The positive pressure air pips are connectable to a detachable compression sleeve configured to inflate and deflate, thereby providing compression therapy, when placed on a body portion of a subject. The negative pressure air pips are connectable to a connectable negative pressure applicator configured for providing a negative pressure therapy. Three or more internal air valves, each with three outlets and two operation states are configured to direct negative pressure created by the one or more pumps through at least one of the negative pressure air pipes connecting the negative pressure applicator or towards the compression sleeve. One or more inflation air valves are configured to direct positive pressure created by the one or more compression pumps through the one or more positive pressure air pipes to the compression sleeve to thereby allow inflation of the connectable compression sleeve. According to some embodiments, a processing circuitry is configured to receive a user-selection therapy, selected from: a negative pressure therapy, or inflation, passive deflation or active deflation of the compression sleeve as part of the compression therapy, and control powering on and off the one or more compression pumps, each of the one or more inflation air valves and each one of the first, second and third internal air valves, to provide said user-selection therapy.

[0060] Reference is now made to FIG. 1 which schematically shows a diagram of a system 100 for combined compression and negative pressure therapy, according to some embodiments. System 100 includes one or more compression pumps such as compression pump 110, three internal air valves 101,102,103, four inflation air valves 111, 112, 113, 114, a detachable compression sleeve 105, a connectable negative pressure applicator 106 and a processing circuitry 107. Compression pump 110 includes positive and negative air outlets 122, 123 respectively. The positive pressure outlet 122 is connected to one or more positive pressure air pipes 124 and the negative pressure outlet 123 is connected to one or more negative pressure air pipes 125. Inflation air valves 111, 112, 113 and 114 are configured to direct positive pressure created by compression pump 110 through positive pressure air pipes 124 to compression sleeve 105 to thereby allow inflation of compression sleeve 105. Compression sleeve 105 is configured to inflate and deflate, and to thereby provide compression therapy, when placed on a body portion of a subject. The compression therapy includes inflation and deflation, where the deflation may be passive deflation or active deflation. Negative pressure applicator 106 is configured for providing a negative pressure therapy. According to some embodiments, each of the internal air valves 101, 102 and 103 has three outlets and two operation states (i.e., on or off), and is configured to direct negative pressure created by compression pump 110 through at least one of negative pressure air pipes 125 connecting negative pressure applicator 106, thereby allowing negative pressure therapy or towards compression sleeve 105 to thereby allow deflation of connectable compression sleeve 105. According to some embodiments, internal air valve 101 is configured to be off when positive pressure created by compression pump 110 is directed to compression sleeve 105. According to some embodiments, internal air valve 101 is configured to be on when the positive pressure is directed to the atmosphere and not to the compression sleeve. According to some embodiments, internal air valve 102 is configured to be on when negative pressure generated by compression pump 110 is directed to negative pressure applicator 106. According to some embodiments, internal air valve 102 is configured to be off when directing the negative pressure to internal valve 103 and not to negative pressure applicator 106. According to some embodiments, internal air valve 103 is configured to be on when directing negative pressure generated by compression pump 110 (which passes through internal air valve 102) to compression sleeve 105. According to some embodiments, internal air valve 103 is configured to be off when directing negative pressure generated by compression pump 110 to the atmosphere and not to compression sleeve 105. This configuration of internal air valve 103 being connected through internal air valve 102, advantageously enables having only one path from negative pressure outlet of compression pump 110 to the free atmosphere. Actually, according to some embodiments, connecting internal air valve 102 through internal air valve 103 creates a valve having four outlets (connection to compression pump 110, connection to negative pressure applicator 106, connection to compression sleeve 105 and connection to the free atmosphere) and three operation states of negative pressure therapy, active deflation or directing the negative pressure to the free atmosphere).

[0061] According to some embodiments, inflation air valves 111, 112, 113 and 114 are configured to be on when directing positive pressure generated by compression pump 110 to compression sleeve 105. According to some embodiments, inflation air valves 111, 112, 113 and 114 are configured to be off, when allowing one of two states, depending on the state of internal air valve 103. The first state is directing negative pressure generated by compression pump 110 to compression sleeve 105 allowing active deflation of compression sleeve 105, this happens when internal air internal air valve 103 is on. The second state is allowing air accumulated in compression sleeve 105 to deflate and be directed to the atmosphere. This happens when internal air valve 103 is off.

[0062] According to some embodiments, processing circuitry 107 is configured to receive a user-selection therapy, selected from: a negative pressure therapy, or inflation, passive deflation or active deflation of the compression sleeve as part of the compression therapy, and control powering on and off compression pump 110, each of inflation air valves 111, 112, 113, 114 and each one of the three internal air valves, 101, 102, 103 to provide said user-selection therapy.

[0063] According to some embodiments, system 100 may include one or more compression pumps such as compression pump 110. For example, two, three, four or more compression pumps for allowing more (or less) air flow. Each of the one or more compression pumps is controlled by processing circuitry 107.

[0064] According to some embodiments, system 100 may include three or more internal air valves. According to some embodiments system 100 may include one or more inflation air valves for pressurizing one or more air zones in the detachable compression sleeve 105. For example, and as shown in FIG. 1, system 100 includes four inflation air valves 111, 112, 113 and 114 for pressurizing four air zones in the detachable compression sleeve 105. Each of the inflation air valves and the internal air valves is controlled by processing circuitry 107. According to some embodiments system 100 includes a negative pressure sensor 127 and a positive pressure sensor 128.

[0065] According to some embodiments, for negative pressure therapy, processing circuitry 107 is configured to power on first and second internal air valves 101 and 102 and the compression pump 110. After negative pressure sensor 127 reads a pressure that is lower than a first predefined threshold, processing circuitry 107 is configured to power off the compression pump 110.

[0066] According to some embodiments, for inflation of attached compression sleeve 105 (as part of the compression therapy), processing circuitry 107 is configured to power on one inflation air valve out of air valves 111, 112, 113 and 114. The powered inflation air valve is a first inflation air valve out of a sequence of inflation determined by the user in order to pressurize different air zones in detachable compression sleeve inflation. After positive pressure sensor 128 reads a pressure that is higher than a second threshold, i.e., once the positive pressure has reached a predefined threshold, processing circuitry 107 is configured to power on one or more subsequent inflation air valves 111, 112, 113 and 114 (i.e., the rest of the inflation sequence) according to the predetermined inflation sequence.

[0067] According to some embodiments, for passive deflation of attached compression sleeve 105 as part of the compression therapy, processing circuitry 107 is configured to power off compression pump 110, and to power off all internal air valves and all inflation air valves 111, 112, 113, 114, according to the predetermined inflation sequence.

[0068] According to some embodiments, for active deflation of attached compression sleeve 105 as part of the compression therapy, processing circuitry 107 is configured to power on inflation air valves 111, 112, 113 and 114, first and third internal air valves 101 and 103 and compression pump 110. After a given period of time (predetermined), processing circuitry 107 is configured to power off compression pump 110. Alternatively, according to some embodiments, processing circuitry 107 may be configured to power off compression pump 110 when an additional negative pressure sensor located online between internal air valve 103 to inflation air valves 111, 112, 113 and 114, (not shown) reads a pressure that is lower than a third predefined threshold. According to some embodiments, a method is presented herein for a combined compression and negative pressure therapy in a single device which is compact modular and easy to use. FIG. 2 schematically shows a flow -chart of a method for combined compression and negative pressure therapy, using system 100, according to some embodiments. At step 202, a user-selection therapy is received. The user-selected therapy is selected from: a negative pressure therapy, and a compression therapy comprising inflation and deflation of compression sleeve 105. At step 204, powering on and off compression pump 110, each of the inflation air valves 111, 112, 113 and 114 and each one of the internal air valves 101, 102 and 103, is controlled by processing circuitry 110 to provide one of said user-selection therapy.

[0069] FIG. 3A schematically shows a flow chart of a method for providing a negative pressure therapy treatment, using system 100 presented in FIG. 1, according to some embodiments. At step 301, according to some embodiments, first and second internal air valves 101 and 102 are powered on by processing circuitry 107. At step 302 compression pump 110 is powered on by processing circuitry 107. At step 303, it is checked if negative pressure sensor

[0070] 127 reads a pressure that is lower than a first predefined threshold. At step 304 once negative pressure sensor 127 reads a pressure that is lower than a first predefined threshold, compression pump 110 is powered off, to stop the negative pressure therapy.

[0071] FIG. 3B schematically shows a flow-chart of a method for providing inflation as part of the compression therapy using the system presented in FIG. 1, according to some embodiments. At step 311, for inflation of attached compression sleeve 105, one inflation air valve out of air valves 111, 112, 113 and 114 is configured to be powered on by processing circuitry 107. According to some embodiments, the powered inflation air valve is a first inflation air valve out of a sequence of inflation determined by the user in order to pressurize different air zones in detachable compression sleeve 105. At step 312 compression pump 110 is powered on by processing circuitry 107. At step 313, it is checked if positive pressure sensor

[0072] 128 reads a pressure that is higher than a second threshold, i.e., when the positive pressure reaches a predefined threshold. At step 314, after positive pressure sensor 128 reads a pressure that is higher than a second threshold, one or more subsequent inflation air valves 111, 112, 113 and 114 which are the rest of the inflation sequence are configured to be powered on by processing circuitry 107, according to the predetermined inflation sequence.

[0073] FIG. 3C schematically shows a flow chart of a method for providing passive deflation as part of a compression therapy using the system presented in FIG. 1, according to some embodiments. In this case, at step 321 compression pump 110 is configured to be powered off by processing circuitry 107, and at step 322, all internal air valves and all inflation air valves 111, 112, 113, 114, are configured to be powered off by processing circuitry 107, according to the predetermined inflation sequence.

[0074] FIG. 3D schematically shows a flow chart of a method for providing an active deflation of the attached compression sleeve 105 as part of the compression therapy, using the system presented in FIG. 1, according to some embodiments. At step 331, internal air valves 101 and 103 are configured to be powered on. At step 332, compression pump 110 is configured to be powered on by processing circuitry 107. At step 333, it is checked when a given period of time (predetermined) has passed, or if additional negative pressure sensor reads a pressure that is lower than a third predefined threshold. At step 334, once the predetermined time period has passed or once the additional negative pressure sensor reads a pressure that is lower than a third predefined threshold, compression pump 110 is powered off by processing circuitry 107.

[0075] Table 1 schematically presents states of internal air valves 101, 102 and 103 and the inflation air valves 111-114, of system 100, for each therapy provided, according to some embodiments.

[0076] Table 1:

[0077] According to some embodiments, a device for combined compression and negative pressure therapy is presented herein. According to some embodiments, the device includes one or more compression pumps such as compression pump 110, having positive and negative air outlets, connected to one or more positive pressure and one or more negative pressure air pipes. According to some embodiments, the device includes three or more internal air valves such as internal air valves 101, 102 and 103 configured to direct negative pressure created by the one or more pumps through at least one of the negative pressure air pipes, which are configured to connect to a negative pressure applicator such as 106, thereby allowing negative pressure therapy, or towards a connectable compression sleeve such as 105 to thereby allow deflation of the connectable compression sleeve.

[0078] According to some embodiments, the device includes one or more inflation air valves such as inflation air valves 111, 112, 113 and 114 configured to direct positive pressure created by the one or more compression pumps through the one or more positive pressure air pipes configured to connect to a connectable compression sleeve to thereby allow inflation of the connectable compression sleeve, and the device also includes a processing circuitry configured to receive a user-selection therapy, selected from: a negative pressure therapy, or inflation, passive deflation or active deflation of the compression sleeve as part of the compression therapy, and control powering on and off the one or more compression pumps, each of the one or more inflation air valves and each one of the first, second and third internal air valves, to provide said user-selection therapy.

[0079] FIG. 4A schematically shows an example of a device for combined compression and negative pressure therapy, according to some embodiments. Device 400 includes a user interface front panel with buttons 402a, 402b, 402c, 402d and 402e, a display 403, outlets 414, outlet 415 and handle 416. Button 402a is the on / off button of device 400. When it is turned on the user presses button 402b for presenting the modes of operation on display 403. The mode of operations are selected from negative pressure therapy or compression therapy which includes inflation, passive deflation or active deflation. Button 402c is used to scroll up, button 402d is used to scroll down and button 402e is used to select the mode of operation. In addition, when an inflation mode is selected (as part of the compression therapy) a list of possible air zones to be pressurized are presented to the user on display 403. The user selects a sequence of zones according to which the inflation air valves will be pressurized.

[0080] According to some embodiments outlets 414 are configured to be connectable to a detachable compression sleeve such as compression sleeve 105, and outlet 415 is configured to be connectable to a negative pressure applicator 406 which is shown in FIG. 4A while not being connected. Handle 416 is configured for placing the negative pressure applicator when said applicator is connected to device 400. FIG. 4B schematically shows device 400 connected to a detachable compression sleeve 405 and connected to the negative pressure applicator 406, according to some embodiments. The attached compression sleeve 406 includes one or more bladders, configured to inflate or deflate, to thereby provide compression therapy. The term “bladders” relates to one or more cells capable of being inflated, deflated, or maintain fluid therein. In some embodiments, the bladders disclosed herein may be linearly arranged in a compression sleeve. The bladders may be separate from one another or may have some overlap therebetween. In some embodiments, the bladders may be at least partially fluidly connected thereto.

[0081] According to some embodiments negative pressure applicator 406 includes a cup which is attached to a subject’s skin in a desired body part, to direct the negative pressure to said body part. Negative pressure applicator 406 is shown placed on handle 416.

[0082] According to some embodiments, various compression sleeves may be attached to device 400, for treating different parts of the body, such as legs, arms, torso and the like. According to some embodiments, the body part may be a limb. According to some embodiments, the various compression sleeves may be in different sizes and shapes to make them appropriate for people with different dimensions and different conditions.

[0083] According to some embodiments, both compression (positive pressure) and negative pressure (vacuum) treatments are designed for helping to move excess fluid from an impaired body part to healthy regions of the body, where fluid can be absorbed and processed naturally by the body. Therefore, both treatments of compression and negative pressure therapy are used to treat one or more of the following medical conditions: Primary Lymphedema and Secondary Lymphedema, chronic venous insufficiency, venous stasis ulcers, Edema, Lipedema, reduction of wound healing time and reduction of pain and swelling after injuries and surgeries.

[0084] According to some embodiments, the system is configured for home use or for use in a care-providing facility (such as hospitals, clinics and the like).

[0085] According to some embodiments, the system is configured to be operated by patients which treat themselves, or by a non-professional operator, for example a family member or a friend. Alternatively, the system is configured to be operated by a professional care giver.

[0086] According to some embodiments, both compression and negative pressure modalities provide several treatment configuration options that may be configured by the user for customizing the treatment. There are several options for treatment configuration which may be done by the user. A first option is to use the device (such as device 400) front panel buttons and display, such as buttons 402a-402e and display 403 presented in FIG. 4A. A second option is to use a dedicated mobile application communicating with device 400, via Bluetooth or other wireless communication means. A third option is to use a computer, which is connected to the device via USB interface.

[0087] According to some embodiments, the compression therapy is dynamic, i.e., comprised of sequence of inflation and deflation of the attached compression sleeve 405, each zone or zones of compression sleeve 405 are inflated and / or deflated separately creating a dynamic sequence squeezing the treated limb.

[0088] According to some embodiments, the negative pressure (vacuum) treatment applies an accurate vacuum to a precise part of the body where applicator 406 is placed on the body. Vacuum is built and released according to the user configuration or when applicator 406 is placed and removed from the body.

[0089] Below are several treatment parameters for compression (positive pressure) therapy and negative pressure (vacuum) therapy.

[0090] According to some embodiments, compression (positive pressure) treatment parameters may be for example: pressure level (for example: 50 mmHg, 100 mmHg etc.), wherein pressure can be set to be for all pressure zones or specific, separate pressure for each zone (or zones), treatment duration (minutes or hours), treatment inflation sequence - may be Sequential and Peristaltic (wave like) inflation cycles, rest time between inflation cycles allowing the pressure on the body to be reduced, before beginning subsequent inflation cycle, and active pressure zones (all attached compression sleeve will inflate or only part of the limb should be treated).

[0091] FIG. 5A schematically shows an example of a Sequential inflation cycle, according to some embodiments. The sequence in FIG. 5A includes 12 pressure zones. The sequence starts with pressurizing a first zone and each time a subsequent zone is pressurized in addition to the pressurized zones. Eventually, all 12 pressure zones are pressurized.

[0092] FIG. 5B schematically shows an example of a Peristaltic (wave form) inflation cycle, according to some embodiments. The sequence in this case also includes 12 pressure zones. However, in this case at the beginning zone 501 is first pressurized then, zones 502 and 503 are sequentially added. Then, zones 502, 503 and 504 are pressurized, and afterwards, zones 503, 504 and 505 are pressurized, and so on until zones 508, 509, 510 are pressurized. The next pressurized zones are 510, 511 and 512, then, zones only two zones are pressurized - 511 and 512 and eventually only zone 512 is pressurized.

[0093] According to some embodiments, pressure therapy treatment configuration may be for example, sequential inflation sequence for 60 minutes at pressure of 40 mmHg with 20 seconds rest time between inflation cycles. All pressure zones are active (inflated). Another example is a peristaltic inflation sequence for 30 minutes at pressure of 80 mmHg with 40 seconds rest time between inflation cycles. All pressure zones are active except zone above the knee which is not inflated (avoiding wound above the knee or because of any other reason).

[0094] According to some embodiments, negative pressure (vacuum) treatment parameters may be for example, negative pressure level (such as: -100 mmHg, -200 mmHg and the like), treatment duration (minutes or hours) and continuous negative pressure or in interval manner (i.e., negative pressure is kept in the configured level continuously or negative pressure is built and released in intervals). According to some embodiments, when interval manner is selected, the user may configure the frequency of the intervals (pressure released one per second, one per a few seconds and the like).

[0095] According to some embodiments, negative pressure (vacuum) treatment configuration may be for example, applying a continuous negative pressure of -150 mmHg for 5 minutes or applying negative pressure at a level of -250 mmHg in intervals: 1 second negative pressure, 2 seconds rest time and so on.

[0096] According to some embodiments, the controller unit includes a processing unit or module. According to some embodiments, terms such as “processing”, “computing”, “calculating”, “determining”, “estimating”, “assessing”, “gauging” or the like, may refer to the action and / or processes of a computer or computing system, or similar electronic computing device, that manipulate and / or transform data, represented as physical (e.g. electronic) quantities within the computing system’s registers and / or memories, into other data similarly represented as physical quantities within the computing system’s memories, registers or other such information storage, transmission or display devices. Embodiments of the present disclosure may include apparatuses for performing the operations herein. The apparatuses may be specially constructed for the desired purposes or may include a general -purpose computer(s) selectively activated or reconfigured by a computer program stored in the computer. Such a computer program may be stored in a computer readable storage medium, such as, but not limited to, any type of disk including floppy disks, optical disks, CD-ROMs, magnetic-optical disks, read-only memories (ROMs), random access memories (RAMs), electrically programmable read-only memories (EPROMs), electrically erasable and programmable read only memories (EEPROMs), magnetic or optical cards, or any other type of media suitable for storing electronic instructions, and capable of being coupled to a computer system bus. The processes and displays presented are not inherently related to any particular computer or other apparatus. Various general -purpose systems may be used with programs in accordance with the teachings herein, or it may prove convenient to construct a more specialized apparatus to perform the desired method(s). In addition, embodiments of the present disclosure are not described with reference to any particular programming language. It will be appreciated that a variety of programming languages may be used to implement the teachings of the present disclosure as described herein.

[0097] Aspects of the disclosure may be described in the general context of computerexecutable instructions, such as program modules, being executed by a computer. Or processing unit. Generally, program modules include routines, programs, objects, components, data structures, and so forth, which perform particular tasks or implement particular abstract data types. Disclosed embodiments may also be practiced in distributed computing environments where tasks are performed by remote processing devices that are linked through a communications network. In a distributed computing environment, program modules may be located in both local and remote computer storage media including memory storage devices.

[0098] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. No feature described in the context of an embodiment is to be considered an essential feature of that embodiment, unless explicitly specified as such.

[0099] Although steps of methods according to some embodiments may be described in a specific sequence, methods of the invention may comprise some or all of the described steps carried out in a different order. A method of the invention may comprise all of the steps described or only a few of the described steps. No particular step in a disclosed method is to be considered an essential step of that method, unless explicitly specified as such. Although the invention is described in conjunction with specific embodiments thereof, it is evident that numerous alternatives, modifications and variations that are apparent to those skilled in the art may exist. Accordingly, the invention embraces all such alternatives, modifications and variations that fall within the scope of the appended claims. It is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and / or methods set forth herein. Other embodiments may be practiced, and an embodiment may be carried out in various ways.

[0100] The phraseology and terminology employed herein are for descriptive purpose and should not be regarded as limiting. Citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the invention. Section headings are used herein to ease understanding of the specification and should not be construed as necessarily limiting.

Claims

Claims1. A system for combined compression and negative pressure therapy, comprising: one or more compression pumps comprising positive and negative air outlets, connected to one or more positive pressure and one or more negative pressure air pipes; a detachable compression sleeve configured to inflate and deflate, thereby providing compression therapy, when placed on a body portion of a subject; a connectable negative pressure applicator configured for providing a negative pressure therapy; three or more internal air valves, each valve with three outlets and two operation states, configured to direct negative pressure created by the one or more pumps through at least one of the negative pressure air pipes connecting the negative pressure applicator, thereby allowing negative pressure therapy, or towards the compression sleeve to thereby allow deflation of the connectable compression sleeve; one or more inflation air valves configured to direct positive pressure created by the one or more compression pumps through the one or more positive pressure air pipes to the compression sleeve to thereby allow inflation of the connectable compression sleeve; and a processing circuitry configured to: receive a user-selection therapy, selected from: a negative pressure therapy, or inflation, passive deflation or active deflation of the compression sleeve as part of the compression therapy; and control powering on and off the one or more compression pumps, each of the one or more inflation air valves and each one of the first, second and third internal air valves, to provide said user-selection therapy.

2. The system of claim 1, further comprising a negative pressure sensor.

3. The system of claim 1 or claim 2, wherein for negative pressure therapy, the processing circuitry is configured to power on the first and second internal air valves and the one or more compression pumps and after the negative pressure sensor reads a pressure that is lower than a first predefined threshold, the processing circuitry is configured to power off the one or more compression pumps.

4. The system of any one of claims 1-3, further comprising a positive pressure sensor.

5. The system of claim 4, wherein for inflation of the attached compression sleeve, the processing circuitry is configured to power on one inflation air valve and after the positive pressure sensor reads a pressure that is higher than a second threshold, the processing circuitry is configured to power on one or more subsequent inflation air valves according to a predetermined inflation sequence.

6. The system of any one of claims 1-5, wherein for inflation of the attached compression sleeve, the processing circuitry is configured to power on the one or more inflation air valves according to a predetermined inflation sequence.

7. The system of any one of claims 1-6, wherein for passive deflation of the attached compression sleeve, the processing circuitry is configured to power off the one or more compression pumps, all of the three or more of internal air valves and all of the one or more inflation air valves.

8. The system of claim 4, wherein for active deflation of the attached compression sleeve, the processing circuitry is configured to power on the first and third internal air valves and the one or more compression pumps, and after given period of time, the processing circuitry is configured to power off the one or more compression pumps.

9. The system of claim 8, further comprising an additional negative pressure sensor wherein for active deflation of the attached compression sleeve, the processing circuitry is configured to power on the one or more inflation air valves, the first and third internal air valves and the one or more compression pumps, and after the additional negative pressure sensor reads a pressure that is lower than a third predefined threshold, the processing circuitry is configured to power off the one or more compression pumps.

10. The system of any one of claims 1-9, wherein the negative pressure therapy and the compression therapy are used to treat one or more of the following medical conditions: Primary Lymphedema and Secondary Lymphedema, chronic venous insufficiency, venous stasis ulcers, Edema, Lipedema, reduction of wound healing time and reduction of pain and swelling after injuries and surgeries.

11. The system of any one of claims 1-10, wherein the attached compression sleeve comprises one or more bladders, configured to inflate or deflate, to thereby provide compression therapy.

12. The system of any one of claims 1-11, wherein the body part comprises a limb.

13. The system of any one of claims 1-12, wherein the system is configured for home use.

14. The system of any one of claims 1-13, wherein the system is configured for use in a care-providing facility.

15. The system of any one of claims 1-14, wherein the system is configured to be operated by a non-professional operator or a professional care giver.

16. A method for a combined compression and negative pressure therapy, using the system of any one of claims 1-15, comprising the steps of: receiving a user-selection therapy, selected from: a negative pressure therapy, and a compression therapy comprising inflation and deflation of a compression sleeve; and controlling, by the processing circuitry, powering on and off the one or more compression pumps, each of the one or more inflation air valves and each one of the internal air valves, providing one of said user-selection therapy.

17. The method of claim 16, wherein for negative pressure therapy, the method comprising powering on the first and second internal air valves and the one or more compression pumps and after a negative pressure sensor reads a pressure that is lower than a first predefined threshold, powering off the one or more compression pumps.

18. The method of claim 16 or 17, wherein for inflation of the compression sleeve, the method comprising powering on one inflation air valves and after a positive pressure sensor reads a pressure that is higher than a second threshold, powering on one or more subsequent inflation air valves according to a predetermined inflation sequence.

19. The method of any one of claims 16-18, wherein for inflation of the compression sleeve, the method comprises powering on the one or more inflation air valves according to a predetermined inflation sequence.

20. The method of any one of claims 16-19, wherein for passive deflation, the method comprises powering off the one or more compression pumps, all of the three or more internal air valves and all of the one or more inflation air valves.

21. The method any one of claims 16-20, wherein for active deflation, the method comprising powering on the one or more inflation air valves, the first and third internal air valves and the one or more compression pumps, and after a positive pressure sensorreads a pressure that is lower than a third predefined threshold, powering off the one or more compression pumps.

22. The method of any one of claims 16-21, wherein the negative pressure therapy and the compression therapy are used to treat one or more of the following medical conditions: primary lymphedema, secondary lymphedema, chronic venous insufficiency, Venous stasis ulcers, edema, lipedema, reduction of wound healing time and / or reduction of swelling after injury or surgery.

23. A device for combined compression and negative pressure therapy, comprising: one or more compression pumps comprising positive and negative air outlets, connected to one or more positive pressure and one or more negative pressure air pipes; three or more internal air valves configured to direct negative pressure created by the one or more pumps through at least one of the negative pressure air pipes, which are configured to connect to a negative pressure applicator, thereby allowing negative pressure therapy, or towards a connectable compression sleeve to thereby allow deflation of the connectable compression sleeve; one or more inflation air valves configured to direct positive pressure created by the one or more compression pumps through the one or more positive pressure air pipes configured to connect to a connectable compression sleeve to thereby allow inflation of the connectable compression sleeve; and a processing circuitry configured to: receive a user-selection therapy, selected from: a negative pressure therapy, or inflation, passive deflation or active deflation of the compression sleeve as part of the compression therapy; and control powering on and off the one or more compression pumps, each of the one or more inflation air valves and each one of the first, second and third internal air valves, to provide said user-selection therapy.

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