Compression system and method for treating endometriosis or adenomyosis

Abstract

Provided herein is a compression system for providing compression therapy to a subject afflicted with endometriosis or adenomyosis, the system includes a compression garment having a plurality of inflatable bladders and a controller device configured to control the pressure in the inflatable chambers, according to a spatial-temporal pattern, to provide a compression therapy to the body region and to at least partially alleviate symptoms associated with endometriosis or adenomyosis.

Description

[0001] COMPRESSION SYSTEM AND METHOD FOR TREATING ENDOMETRIOSIS OR ADENOMYOSIS

[0002] FIELD OF THE INVENTION

[0003] Provided herein are system, device and method for providing compression therapy for alleviating symptoms associated with endometriosis or adenomyosis.

[0004] BACKGROUND

[0005] Endometriosis is a medical condition where tissue similar to the lining of the uterus grows outside the uterus. It often affects the ovaries, fallopian tubes and the tissue lining the pelvis. Adenomyosis is a similar condition where the endometrial tissue grows into the muscular wall of the uterus, thickening the wall. In normal condition endometriosis tissue acts as the lining inside the uterus would - it thickens, breaks down and bleeds with each menstrual cycle. However, when it grows in abnormal regions it does not leave the body. When endometriosis involves the ovaries, cysts called endometriomas may form. Surrounding tissue can become irritated and form scar tissue. Bands of fibrous tissue called adhesions also may form. These can cause pelvic tissues and organs to stick to each other.

[0006] While there is no cure for endometriosis or adenomyosis, there are various treatment options available to manage symptoms and improve the quality of life for individuals with this condition. Treatment plans may vary depending on the severity of symptoms, the extent of the disease, and individual preferences. Some common methods of treating endometriosis include pain medications, hormonal therapy, non-hormonal medications, ablation, laproscopic surgery, laparotomy, and other alternative therapies such as acupuncture, medical cannabis, herbal supplements, dietary changes and the like.

[0007] 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. Other types of compression therapy utilize 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 body parts of a subject. There remains a need in the art for effective systems and methods for alleviating pain and symptoms associated with endometriosis or adenomyosis, by providing targeted compression therapy, in an accurate, safe, adjustable and cost-effective manner.

[0008] SUMMARY

[0009] Aspects of the invention, in some embodiments thereof, relate to systems, devices and methods for providing compression therapy to a subject in need thereof, for the treatment (i.e., manage symptoms) associated with endometriosis and / or adenomyosis.

[0010] According to some embodiments, there are provided herein advantageous inflatable compression systems, for example, in the form of a belt or garment having a plurality of compression / inflatable chambers, each of the chambers may include one or more inflatable bladders / pockets, capable of providing efficient pneumatic compression therapy to a body region (such as, abdomen) of a subject suffering from endometriosis or adenomyosis, wherein the compression device is adjustable to conform to the body region, so as to facilitate efficient alleviation of at least some of the symptoms associated with these conditions.

[0011] Advantageously, the compression systems disclosed herein provide a customized compression therapy, allowing the ordered dispersion of adjustable amount of pressure, at a desired spatial-temporal pattern, to selected body regions, to thereby allow improvement of blood circulation is the treated area, to facilitate endometriosis and / or adenomyosis treatment and optionally enhance / improve fertility.

[0012] According to some embodiments, there are provided herein pneumatic compression system and method, for applying compression / pressure to a woman abdomen, buttock, lower back, groins and / or hips in order to encourage blood circulation, separate tissues and organs that may adhere thereto and stimulate the nerve system to reduce pain level associated with endometriosis, adenomyosis or similar conditions.

[0013] According to some embodiments, there is provided a compression system for providing compression therapy to a body region of a subject afflicted with endometriosis or adenomyosis, the compression system includes: a wearable compression garment configured to be placed on or around the body region of the subject, said garment includes a plurality of inflatable chambers, the chambers configured to face and be engageable with the body region of the subject; and a controller device, configured to control operation of the inflatable chambers, according to a spatial-temporal pattern, to thereby provide compression therapy to the body region, to at least partially alleviate symptoms associated with endometriosis or adenomyosis.

[0014] According to some embodiments, the system further includes a fluid compression unit configured to inflate and / or deflate each of the chambers. According to some embodiments, the compression unit is connected via a fluid distribution unit and corresponding conduits to each of the chambers.

[0015] According to some embodiments, at least some of the chambers may include at least two inflatable pockets, arranged horizontally or vertically within the chamber.

[0016] According to some embodiments, the spatial-temporal pattern includes: order of operation of the chambers, time length of operation of each chamber; target pressure in each of the chambers at inflation and / or deflation, pause length between operations, number of repeats of operations, or any combinations thereof. Each possibility is a separate embodiment.

[0017] According to some embodiments, the order of operation includes sequential or concomitant operation of a single chamber, of a group of chambers, and / or of individual inflatable pockets within a chamber. Each possibility is a separate embodiment.

[0018] According to some embodiments, the length of operation of each chamber includes: time length to inflate the chamber to a target pressure, time length to deflate the chamber, time length over which the chamber is inflated (hold time); time length between operation of sequential chambers, or any combination thereof. Each possibility is a separate embodiment. According to some embodiments, the pressure includes: target pressure of an inflated chamber, target pressure of inflated pockets with a chamber, and / or pressure of a deflated chamber. Each possibility is a separate embodiment.

[0019] According to some embodiments, the target pressure is in the range of about 10 to 300 mmHg.

[0020] According to some embodiments, the spatial-temporal pattern is predetermined.

[0021] According to some embodiments, the spatial-temporal pattern is customized, in accordance with the subject condition.

[0022] According to some embodiments, the spatial-temporal pattern is adjustable in real time, by a user.

[0023] According to some embodiments, the spatial-temporal pattern is customized or adjustable, based on input received from the subject.

[0024] According to some embodiments, the system may further include one or more valves and one or more pressure sensors.

[0025] According to some embodiments, the system may further include a communication unit and / or a user interface.

[0026] According to some embodiments, the garment may further include one or more heating elements configured to provide localized heat to the body region.

[0027] According to some embodiments, the heating elements are embedded with or associated with the garment.

[0028] According to some embodiments, the heating elements may include: LED heating element(s), heating coil(s), infra-red heating element(s), or any combination thereof.

[0029] According to some embodiments, the garment may include fasteners configured to secure the garment to the body of the subject.

[0030] According to some embodiments, walls of the inflatable chambers are made of sheets of PE, EVA, PVC and / or TPU. According to some embodiments, the wearable garment is flexible.

[0031] According to some embodiments, the body region may include: abdomen, lower back, buttocks, groins and / or hips.

[0032] According to some embodiments, the body region is abdomen and the garment includes six groups of inflatable chambers.

[0033] According to some embodiments, the garment is configured to be positioned over the abdomen region of the subject such that: a first group of inflatable chamber(s) is configured to be placed essentially above (superior to) naval region; a second and a third group of inflatable chamber(s), located on opposing lateral sides of the first group and configured to be placed essentially over left and right upper quadrants of the abdomen; a fourth group of inflatable chamber(s) configured to be placed essentially below (inferior to) naval region and superiorly to groin region of the subject; and a fifth and a sixth group of inflatable chamber(s), located on opposing lateral sides of the fourth group and configured to be placed essentially over left and right lower quadrants of the abdomen.

[0034] According to some embodiments, the symptoms are selected from: pain, tissue adherence, organ adherence, cysts, or any combination thereof.

[0035] According to some embodiments, the system may be used for enhancing blood circulation in abdomen body region, to thereby enhance condition and / or function of reproductive organs of the subject.

[0036] According to some embodiments, there is provided a method for providing a compression therapy to a body region of a subject afflicted with a condition selected from endometriosis or adenomyosis, the method includes: placing the wearable garment of the compression system as disclosed herein, on the subject, such that the inflatable chambers of the compression sleeve are at least partially engageable with a body region of the subject; and controlling the pressure in the inflatable compression chambers, according to a spatial -temporal pattern, to provide a compression therapy to the body region and thereby at least partially alleviate symptoms associated with the condition.

[0037] According to some embodiments, controlling the pressure is facilitated using the control unit.

[0038] According to some embodiments, the method may further include fastening or securing the wearable garment to the subject.

[0039] According to some embodiments, the method may further include activating heating elements of the compression device, to thereby provide heat therapy to the subject.

[0040] According to some embodiments, the method may further include receiving, from the subject, user specific information, to thereby allow adjustment of the compression therapy.

[0041] According to some embodiments, the method is configured to at least partially enhance localized or systemic blood circulation, facilitate separation of tissue and / or organ adherence thereto, stimulate nerve system and / or reduce localized or systemic pain levels of the subject. Each possibility is a separate embodiment.

[0042] According to some embodiments, the condition is endometriosis, and the body region is abdomen.

[0043] According to some embodiments, the method may facilitate enhancing blood circulation in abdomen body region, to thereby enhance condition and / or function of reproductive organs of the subject. 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.

[0044] 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.

[0045] BRIEF DESCRIPTION OF THE FIGURES

[0046] 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.

[0047] In the Figures:

[0048] Fig. 1 - a schematic illustration of a compression system, according to some embodiments;

[0049] Fig. 2 - a schematic electromechanical scheme of a compression system, according to some embodiments;

[0050] Fig. 3A - a schematic illustration of a front view of the front (internal) face of a compression garment, according to some embodiments;

[0051] Fig. 3B - a schematic illustration of a front view of the back (external) face of a compression garment, according to some embodiments; Fig. 4A - a schematic perspective view of a compression garment, according to some embodiments;

[0052] Fig. 4B - a schematic perspective view of a compression garment placed on a subject body, according to some embodiments;

[0053] Fig. 5- a schematic illustration of a front face of a compression garment having heating elements, according to some embodiments;

[0054] Fig. 6 - a schematic illustration of an exemplary chamber having a plurality of pockets, according to some embodiments; and

[0055] Fig. 7 - a schematic illustration of an exemplary compression garment positioned on abdomen body region of a subject, according to some embodiments.

[0056] DETAILED DESCRIPTION

[0057] 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.

[0058] 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.

[0059] As used herein, “right” and “left” refer to the right and left directions from the center of body of a subject. In some embodiments, left and right are determined by the sagittal plane (longitudinal, anteroposterior), which is parallel to the sagittal suture. In some embodiments, the terms "left" and "left hand side" may interchangeably be used. In some embodiments, the terms "right" and "right hand side" may interchangeably be used. In some embodiments, the term “lateral” relates to being on sideways (e.g., left or right to) of another object. As used herein, the terms "top" and "bottom" refer to top and bottom directions of a subject body. In some embodiments, "top" (interchangeable with “superior”) is relatively closer to the head region and "lower" (interchangeably with “inferior”) is relatively closer to the leg region. In some embodiments, top and bottom are relative to the transverse plane (axial or horizontal plane), which divides the body into cranial and caudal (head and tail) portions.

[0060] As used herein, the term “chamber” relates to a cell capable of being inflated, deflated, or maintain fluid therein. In some embodiments, a chamber may include a single internal inflatable space, or may include two or more “pockets” (also referred to as “bladders”), each functions as a cell capable of being inflated, deflated, or maintain fluid therein, wherein such a group of pockets may be fluidly connected thereto. In some embodiments, In some embodiments, the pockets may be linearly (horizontally or vertically) arranged in a chamber. The bladders may be separate from one another or may have some overlap therebetween.

[0061] As used herein, the terms "subject" and "patient" may interchangeably be used. The term relates to a female subject afflicted with or having symptoms of endometriosis, or Adenomyosis.

[0062] As used herein, the term "treating" relates to application of compression therapy to a subject in need thereof. In some embodiments, the treatment can at least partially ameliorate one or more symptoms associated with or related to the endometriosis, and / or adenomyosis, including, for example, but not limited to: reducing pain, enhancing blood circulation (localized or systemic), reducing tissue adherence, reducing internal organ adherence, and the like, or any combinations thereof. Each possibility is a separate embodiment. In some embodiments, the treating further relates to enhancement of blood circulation to reproductive organs (such as ovary and uterus), to thereby affect their physiological condition and / or biological activity. In some embodiments, such enhancement may affect fertility of the subject.

[0063] As used herein, the terms "health care provider", "user", "physician" relate to a provider of therapy to a subject in need thereof. 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 neighborhood 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.

[0064] According to some embodiments, there is provided an compression system that includes a wearable garment which is configured to be placed on or around a selected body region of the subject (such as, for example, abdomen, hips, groin, etc.), wherein the garment includes a plurality of inflatable chambers, positioned according to a predetermined pattern, wherein each of the chambers configured to face and be engageable with the body region; and a controller device which is configured to control operation of the inflatable chambers according to a spatial-temporal pattern to thereby provide compression therapy to the body region, to at least partially alleviate symptoms associated with endometriosis or adenomyosis.

[0065] Reference is now made to Fig. 1, which schematically shows a diagram of a system for compression therapy for endometriosis or adenomyosis subjects, according to some embodiments. As shown in Fig. 1, system 100 includes a controller device 120, which is configured to control operation of inflatable chambers of garment 130, by, for example, controlling the operation of one or more fluid compressors (shown as compressor 106), configured to provide fluid, such as, air, to the inflatable chambers of garment 130. The compressor may be of any suitable type and is configured to provide any suitable amount / pressure of fluids to the inflatable chambers. The passage of fluid to / from the chambers, is facilitated via fluid tubes 112, which are configured to connect fluid distribution system 108 (connected to compressor 106 via fluid tubes 110) and the chambers of garment 130. Fluid distribution system 108 includes one or more pressure sensors and one or more valves. The valves may be of any type, and in some exemplary embodiments, the valves may be electrical solenoid valves. In some embodiments, each chamber may be associated with or connected to a sperate valve. In some embodiments, one or more chambers may be associated with or connected to a common valve. The operation of the units of controller device are controlled by controller unit 102 of the device. Controller unit 102 includes one or more one or more processors, control boards, memory modules, and the like, or combinations thereof. In addition, control device 120 may further include a user interface unit (UI). The User interface unit may include one or more of: keyboard, display, tracking device, touch screen, or any combination thereof, allowing a user (such as a health care provider) to interact with the controller device. Interacting with the controller device may include, for example, determining operating parameters, reviewing operating parameters, monitoring operation, and the like. Controller device 120 may further optionally include a communication unit. In some embodiments, the communication unit may include wired and / or wireless communication modalities. In some embodiments, the communication unit may include Bluetooth communication modality, Wi-Fi communication modality, Near field communication modality (NFC), USB, HDMI, ethemet, or combinations thereof. The communication unit may be used to convey information to and from the controller device. Controller device 120 further includes a power supply 104 configured to provide electrical power to components of the compression system. Compression garment 130 is configured to be placed on a subject body 150, at a designated body region (for example, abdomen), such that the inflatable chambers of garment 130 face and engage the body region, such that compression therapy (e.g., by spatio-temporal pattern of inflation / deflation of the chambers) is provided to the body region.

[0066] According to some embodiments, the controller device may be comprised in a suitable housing. In some embodiments, the controller device may be in the form of a console, which may be stationary or portable.

[0067] Reference is now made to Fig. 2, which shows an exemplary schematic electromechanical scheme of a compression system, according to some embodiments. As shown in Fig. 2, controller device 220 of compression system 200, is fluidly connected to compression garment 230, via fluid conduits (represented by solid lines). The fluid flow to / from fluid conduits are controllable by valves, such as valves 206a-d, which can be, for example, solenoid valves. The operation of the valves (open / close) can be controlled electrically by controller unit 202 of controller device 220. The operation of the valves may be determined, at least partially based on information received from a pressure sensor, such as pressure sensor 212. In some embodiments, as in the example shown in Fig. 2, the controller device may further include non-retum valves (shown as valves 208a-d) and / or pressure relief valves, (shown as exemplary valve 209). As further shown in Fig. 2, chambers (such as chambers 222 a-d) of garment 230, are fluidly connected to the fluid compressor 204, via fluid conduits (represented by solid lines), wherein the inflation / deflation of each chamber is capable of being controlled by the respective valve. For example, valve 206a is associated with chamber 222a. Each of the chambers may have in opening (inlet), allowing the insertion / removal of fluid from the internal volume thereof.

[0068] Reference is now made to Fig. 3A, which shows a schematic illustration of a front view of the front (internal) face of a compression garment, according to some embodiments. Shown in Fig. 3A, is a front view of the front face of garment 330, which is configured to face (and engage) the body region of the subject. As shown in Fig. 3A, compression garment 320 includes a body 326, which is made of a suitable flexible material, such as, fabric, and a plurality of compression chambers, shown as exemplary chambers 322A-F. The chambers may be arranged / positioned in groups, such that they can conform to a designated body region of a subject. For example, garment 330 can conform to abdomen body region of a subject. The chambers may be arranged in groups, such that some of the chambers are positioned, for example, above the naval line of the subject, and some are below. In some embodiments, as further detailed herein below, one or more of the chambers may include at least two individual pockets that collectively define a chamber. In the example shown in Fig. 3 A, each of the chambers 322A-322F, is comprised of two pockets (322A’-322F’ and 322A”-322F”). As further detailed herein below, based on a designated spatio-temporal pattern of operation, the different chambers (or chamber groups) may be inflated / deflated, according to a desired order, timing and / or amount of pressure. By enabling a desired and effective spatial temporal operation of inflation / deflation of the various chambers, an efficient treatment is facilitated. The treatment may be adjusted to the specific user (for example, by controlling the pattern of operation of the chambers, the timing of operation, the length of operation, the target pressure, and the like). According to some embodiments, the chambers may be constructed of any suitable material. For example, walls of the chambers may be made of such materials as, but not limited to: polyethylene (PE), ethylene-vinyl acetate (EVA), or polyvinyl chloride (PVC), thermoplastic polyurethane (TPU), and the like or combinations thereof.

[0069] In some embodiments, the chambers are integrally formed with the garment. In some embodiments, the chambers are associated / attached to the garment, as specific locations on the body of the garment.

[0070] According to some embodiments, ventilation openings of the chambers (not shown in Fig. 3) are configured to allow for the pumping / insertion of fluid (such as, air) into the chamber, and the outflow of fluid (for example by passive or active deflation) from the chamber, thereby inflating and deflating the chambers. According to some embodiments, the ventilation openings may be in the form of a female connector (for example, in the form of a socketed member), or in the form of a male connector (for example, in the form of tubular spouts). Apart from the fluid connectivity provided by the ventilation openings (fluidly connecting the inside of each of the bladders to the outside), the chambers may be fluidly sealed (i.e., airtight). In some embodiments, the ventilation openings may each be connected to a separate fluid tube / hose / valve. In some embodiments, at least some of the ventilation openings may be connected to a common fluid tube / hose / valve.

[0071] According to some embodiments, the pressure in each of the chambers may independently be in the range of about 1-300 mmHg. According to some embodiments, the pressure in each of the chambers may independently be in the range of about 10-300 mmHg. According to some embodiments, the pressure in each of the chambers may independently be in the range of about 10-200 mmHg. According to some embodiments, the pressure in each of the chambers may independently be in the range of about 10-150 mmHg. In some embodiments, each of the chambers may be configured to inflate, deflate or maintain similar or different pressures.

[0072] Reference is now made to Fig. 3B, which shows a schematic illustration of a front view of the back (external) face of a compression garment, according to some embodiments. As shown in Fig. 3B, garment 330, includes at the back face thereof (i.e., the external side that faces away from the subject body), one or more fasteners or buckles (shown as fasteners 340A-D), allowing the placing and securing (for example, by strapping) the garment to / around the subject body. By using such fasteners, the garment can be effectively and adjustably be positioned on the subject body, while enabling correct position of the inflatable chambers on the front face of the garment. As further shown in Fig. 3B, body 326 of the garment 330 may be made of two or more, at least partially separate portions of fabric, that can be combined together at will, for example by aid of securing means, such as, exemplary fastener Velcro attachment 342. By such a setting, further customize fitting of the garment to the subject body is enabled. Attachment 342 may include any type of attachment, including, for example, Zipper. It is noted that the form and structure of the body 326 of garment 330 may be adjusted to the body region. In some embodiments, the garment may be in the form of a belt, configured to be secured around the body (for example, around the waist of the subject, around the groin, etc.).

[0073] Reference is now made to Fig. 4A, showing a schematic perspective view of a compression garment according to some embodiments. As shown in Fig. 4A, garment 430, is in the form of a belt, configured to fit over a subject body, such that body 426 of the garment is configured to be located over a desired body region of interest, such that the internal front face 420 thereof (including the inflatable chambers (not shown)) is facing and engaging the body region to which compression therapy is applied. To this aim, straps 442A-B, are configured to surroundingly engage the subject body, and be connected via fasteners 440A-B, respectively, which are located on the external face of the garment, to thereby secure the garment to the body of the subject. In some embodiments, the straps are integrally formed with the body of the garment. In some embodiments, the straps are reversibly connected to the body of the garment. In some embodiments, the straps are made of the same or similar material as the body of the garment. Shown in Fig. 4B is garment 430, when placed on abdomen region (e.g., above the groin) of subject 450.

[0074] According to some embodiments, the compression system disclosed herein may further include one or more heating elements, which are configured to provide a direct or indirect heating of a target body region area. According to some embodiments, such heating elements may be included with the garment. In some embodiments, the heating elements may be embedded in the garment. In some embodiments, the heating elements may be attached to or associate with the garment. In some embodiments, the heating elements are positioned between, next to, around at least some of the chambers. In some embodiments, the heating elements may receive power from the controller device, that may control their operation, including, for example, the emitted heat energy, length of operation, pattern of operation, timing of operation, and the like. In some embodiments, the heating elements are positioned on the front face of the garment (i.e., the side facing the subject body). In some embodiments, the heating element may include, for example, but not limited to: LED heating elements, coils, infrared (IR), and the like, or any combinations thereof.

[0075] Reference is now made to Fig. 5, which schematically shows a front face of a garment having heating elements, according to some embodiments. As shown in Fig. 5, garment 530, includes a plurality of groups of inflatable chambers (shown as chamber groups 522A-F) on body 526 of the garment, Further shown are exemplary heating elements 524A-F, which are positioned, around an in between groups of chambers. The heating elements may be embedded with the garment, or be attached thereto, and may be dispersed symmetrically, or non-symmetrically on the front face of the garment.

[0076] According to some embodiments, as detailed above herein, one or more of the chamber groups may include two or more inflatable pockets. Such a setting allows increased control and sensitivity over the compression treatment. In some embodiments, each of the pockets of a chamber may be controlled independently. In some embodiments, the pockets of a chamber may be identical or similar with respect of size, structure or composition. In some embodiments, the pockets of the chamber may be different from one another with respect of: size, structure and / or composition. In some embodiments, the pockets may be operated simultaneously (i.e., all the pockets of a chamber inflate / deflate together). In some embodiments, the pockets may operate sequentially. In some embodiments, only some of the pockets may be operated. In some embodiments, the pockets may be arranged horizontally or vertically, within a chamber. In some embodiments, at least some of the pockets may at least partially overlap. In oms embodiments, each of the pockets may have a fluid inlet. Reference is now made to Fig. 6, which schematically shows an exemplary chamber having a plurality of pockets, according to some embodiments. As shown in Fig. 6, chamber 620 includes a plurality of pockets (shown as three distinct pockets, 644A- C). As shown in Fig. 6, the pockets are arranged vertically. The pockets are different in size and shape, such that, in the example shown in Fig. 6, the central pocket 644B, is larger than top and bottom pockets 644A and C. As detailed herein, each of the pockets may be operated independently of the other pockets of the chamber. In some embodiments, each of the pockets is fluidly sealed, and the passage of fluid to / from the pocket is via a dedicated fluid inlet port. In some embodiments, a space between the external walls of the pockets is formed. In some embodiments, no external space is formed between the external walls of the pockets.

[0077] According to some embodiments, the disclosed system can be adjusted to a selected body region of the subject, and to a selected operation spatial -temporal pattern.

[0078] In some embodiments, the selected spatial-temporal pattern may be determined by a user, by a subject, or predetermined. In some embodiments, the spatial -temporal pattern may include, for example, but not limited to: the order of operation of chambers (and / or of internal pockets, if present), the timing of operation of the chambers, the length of operation, the amount of pressure in the chambers, and the like.

[0079] According to some embodiments, the parameters of the operation cycles (spatial- temporal pattern) can be set by a user, for example, via the user interface (prior to or during treatment session), via a remote application (such as, for example a mobile application) capable of interacting with the device via the communication unit of the compression device, and / or may be selected from predetermined settings. In some embodiments, such parameters may include, for example, but not limited to: “Target pressure”, which is the pressure to be reached in each inflated chamber; “Hold time”, which is the time period (for example, in seconds or minutes) for maintaining pressure in a chamber(s) after target pressure is reached and before deflating air from the chamber(s); “Pause time”, which is the time length between successive operation cycles (i.e., time to stop when all chambers are deflated); “Repeat”, which is the number of repetitions of each cycle; and the like, or any combinations thereof. In some embodiments, the compression system may be used with an associated mobile application allowing the subject to provide further information related to the treatment method. Such information may include, for example, menstrual cycle dates, level of pain and the like.

[0080] According to some embodiments, the treatment pattern and / or the garment arrangement may be adjusted based on the body region

[0081] Reference is now made to Fig. 7, which shows a schematic illustration of exemplary garment positioned on abdomen body region of a subject, according to some embodiments. As shown in Fig. 7, wearable garment 730, which includes in this example six chambers, 722A-F, is positioned over abdomen body region 750, such that the chambers face the subject body. As shown in Fig. 7, the garment is positioned such that at least some of the chambers (namely chambers 722A-C) are positioned above (superior to) the naval line 752 of the subject, and at least some of the chambers (namely 722D-F) are positioned below (inferior to) the naval line 752. As further shown in Fig. 7, the chambers are arranged such that a middle / center pocket (namely pockets 722A and 722D) are positioned essentially vertically to the naval, while the other pockets are arranged on either side thereof (i.e., to the left and to the right of the central chambers). Thus, such as arrangement of chambers allows for the positioning of chamber 722A above the naval, thereby covering the top of the stomach up to the diaphragm, chambers 722B-C on both sides of chamber 722A, covering left and right upper quadrants of the abdomen; positioning of chamber 722A in center low region of the abdomen below the naval and above the groin and chambers 722B-C covering left and right lower quadrants of the abdomen. Such an arrangement is configured to provide enhanced compression therapy to the abdomen body region of an endometriosis or adenomyosis subject. Example 1 below provides an exemplary operation pattern for such an exemplary garment.

[0082] According to some embodiments, the compression system, or portions thereof may be disposable. According to some embodiments, the garment may washable and reusable.

[0083] According to some embodiments, the operation / control of operation of the compression device may be utilized using one or more suitable controllers, allowing the inflation / deflation of the inflatable bladders, in order to provide compression therapy to the subject.

[0084] According to some embodiments, the compression therapy system may be utilized continuously or intermittently over any desired period of time beneficial for the subject. In some embodiments, the treatment may be provided is sessions. In some embodiments, the treatment session may be repeated at least once, 2, 4, 6 or more times a day, at any desired time interval therebetween. In some embodiments, each two consecutive treatment sessions may be identical, similar or different therefrom. In some embodiments, the length of a treatment session may be in the range of about 2 minutes to about 6 hours. In some embodiments, the length of a treatment session may be in the range of about 5 minutes to about 1 hour. In some embodiments, the length of a treatment session may be in the range of about 10 minutes to about 2 hours. In some embodiments, the length of a treatment session may be in the range of about 10 minutes to about 30 minutes. In some embodiments, the length of a treatment session may be in the range of about 30 minutes to about 90 minutes.

[0085] According to some embodiments, the compression therapy may enhance or increase localized or systemic blood circulation. In some embodiments, such enhanced blood circulation can affect fertility of the subject, for example, by enhancing blood circulation to organs of the fertility system, including ovaries and / or uterus. In some embodiments, the compression therapy may enhance ovary functioning or health, including, for example, supporting follicular development, supporting ovulation, and the like.

[0086] According to some embodiments, there is provided a method for providing or applying a compression therapy to a subject afflicted with endometriosis or adenomyosis utilizing the advantageous compression system as disclosed herein. According to some embodiments, the compression treatment may include inflating / deflating and / or maintaining pressure in one or more of the chambers of the garment.

[0087] According to some embodiments, controlling the pressure in the compression device may include reducing, maintaining, or increasing the pressure in one or more chambers. In some embodiments, the pressure in each chamber may be similar. In some embodiments, the pressure may change individually in each chamber.

[0088] According to some embodiments, the compression cycles / sessions may be sequential, peristaltic or intermittent, and may be adjusted based on the treatment regime and / or the specific subject. The compression cycle may be adjusted according to the order of inflation / deflation of the various chambers, length of the deflation / inflation, and the like. For example, peristaltic compression may be facilitated by keeping any number of chambers inflated in a given time.

[0089] According to some embodiments, various compression cycles / sessions at desired spatial-temporal patterns may be utilized, in accordance with various parameters, including, for example, but not limited to: characteristics of the subject (age, weight, pain level, menstrual cycle, medical history, and the like), the severity of the condition, the type of condition (endometriosis, adenomyosis), and the like.

[0090] 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.

[0091] 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.

[0092] 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 sub-combination 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.

[0093] 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.

[0094] 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.

[0095] EXAMPLES

[0096] Example 1 - Application of compression therapy to abdomen of a subject

[0097] The device for compression therapy is utilized to provide compression therapy to abdomen of a subject in need thereof. Various compression cycles, at various spatial- temporal patterns may be utilized, in accordance with various parameters, including, for example, but not limited to: age, weight, pain level, menstrual cycle status of the subject, and the like.

[0098] After the garment is placed on the abdomen of the subject, such that the compression chambers are located over their respective body position, the device may be secured, using connected straps to the body of the subject. The compression therapy may then be initiated.

[0099] Listed below are details of exemplary compression therapy patterns, whereby the order, timing and length of operation of the inflation / deflation of the compression chambers are adjusted according to the treatment session / cycle. The compression chambers are numbered, as shown for example, in Fig. 7.

[0100] Compression cycles may be sequential, peristaltic or intermittent as exemplified below:

[0101] The following are the main parameters of the operation cycles. All parameters can be set by a user via the user interface (prior to or during treatment session), or via a dedicated remote application, interacting with the device via the communication unit of the compression device.

[0102] ‘Target pressure’ - pressure to be reached in each inflated chamber - set by the user in a range of between 10 to 300 mmHg.

[0103] ‘Hold time’ - X time period (in seconds) for cycle to stop after target pressure is reached and before deflating air from the chamber(s).

[0104] ‘Pause time’ - time for cycle to stop when all chambers are deflated.

[0105] ‘Repeat’ - number (N) of repetitions of each treatment stage.

[0106] 1. Inflate chamber group # 1 until reaching target pressure,

[0107] 2. Wait for X ‘hold time’.

[0108] 3. Release air from chamber group # 1

[0109] 4. Repeat steps above for ‘Repeat’ N number of times.

[0110] 5. Repeat steps 1-4 above with chamber group #2

[0111] 6. Repeat steps 1-4 above with chamber group #3

[0112] 7. Repeat steps 1-4 above with chamber groups #4

[0113] 8. Repeat steps 1-4 above with chamber groups #5

[0114] 9. Repeat steps 1-4 above with chamber groups #6

[0115] 8. Inflate chamber group #1 until reaching target pressure,

[0116] 9. Inflate chamber group #2 until reaching target pressure,

[0117] 10. Inflate chamber group #5 until reaching target pressure release air (deflate) from chamber group # 1.

[0118] 11. Inflate chamber group #4 until reaching target pressure release air (deflate) from chamber group #2.

[0119] 12. Inflate chamber group #6 until reaching target pressure release air

[0120] (deflate) from chamber group #5. 13. Inflate chamber group #3 until reaching target pressure, release air

[0121] (deflate) from chamber group #4.

[0122] 14. Inflate chamber group #1 until reaching target pressure, release air

[0123] (deflate) from chamber group #6.

[0124] 15. Inflate chamber group #2 until reaching target pressure, release air

[0125] (deflate) from chamber group #3.

[0126] 16. Repeat steps 10-15 for ‘Repeat’ N number of times.

[0127] 17. Release air (deflate) from all chambers In cases where a chamber group includes more than one pocket / bladder (as shown in Fig. 6), inflation of the pockets within a chamber is performed sequentially as follows:

[0128] 1 - inflate pocket # 1 to target pressure

[0129] 2 - inflate pocket #2 to target pressure 3. - inflate pocket #3 to target pressure

[0130] At desired timing (in accordance with the treatment session) deflate all pockets of a chamber sequentially or simultaneously.

Claims

CLAIMSWhat is claimed is:

1. A compression system for providing compression therapy to a body region of a subject afflicted with endometriosis or adenomyosis, the compression system comprising: a wearable compression garment configured to be placed on or around the body region of the subject, said garment comprising a plurality of inflatable chambers configured to face and be engageable with the body region of the subject; and a controller device, configured to control operation of the inflatable chambers, according to a spatial-temporal pattern, to thereby provide compression therapy to the body region, to at least partially alleviate symptoms associated with endometriosis or adenomyosis.

2. The compression system according to claim 1, further comprising a fluid compression unit configured to inflate and / or deflate each of the chambers.

3. The compression system according to claim 2, wherein the compression unit is connected via a fluid distribution unit and corresponding conduits to each of the chambers.

4. The compression system according to any one of claims 1-3, wherein at least some of the chambers comprise at least two inflatable pockets, arranged horizontally or vertically within the chamber.

5. The compression system according to any one of claims 1-4, wherein the spatial -temporal pattern comprises: order of operation of the chambers, time length of operation of each chamber; target pressure in each of the chambers at inflation and / or deflation, pause length between operations, number of repeats of operations.

6. The compression system according to claim 5, wherein the order of operation comprises sequential or concomitant operation of a single chamber, of a group of chambers, and / or of individual inflatable pockets within a chamber.

7. The compression system according to any one of claims 5-6, wherein the length of operation of each chamber comprises: time length to inflate the chamber to a target pressure, time length to deflate the chamber, time length over which the chamber is inflated, time length between operation of sequential chambers, or any combination thereof.

8. The compression system according to any one of claims 5-7, wherein pressure comprises: target pressure of an inflated chamber, target pressure of inflated pockets with a chamber, and / or pressure of a deflated chamber.

9. The compression system according to any one of claims 5-8, wherein the target pressure is in the range of about 10 to 300 mmHg.

10. The compression system according to any one of claims 1-9, wherein the spatial-temporal pattern is predetermined.

11. The compression system according to any one of claims 1-9, wherein the spatial -temporal pattern is customized, in accordance with the subject condition.

12. The compression system according to any one of claims 1-11, wherein the spatial-temporal pattern is adjustable in real time, by a user.

13. The compression system according to any one of claims 11-12, wherein the spatial-temporal pattern is customized or adjustable, based on input received from the subject.

14. The compression system according to any one of claims 1-13, further comprising one or more valves and one or more pressure sensors.

15. The compression system according to any one of claims 1-14, further comprising a communication unit and / or a user interface.

16. The compression system according to any one of claims 1-15, wherein the garment further comprises one or more heating elements configured to provide localized heat to the body region.

17. The compression system according to claim 16, wherein the heating elements are embedded with or associated with the garment.

18. The compression system according to any one of claims 16-17, wherein the heating elements comprise: LED heating element(s), heating coil(s), infra-red heating element(s), or any combination thereof.

19. The compression system according to any one of claims 1-18, wherein the garment comprises fasteners configured to secure the garment to the body of the subject.

20. The compression system according to any one of claims 1-19, wherein walls of the inflatable chambers are made of sheets of PE, EVA, PVC and / or TPU.

21. The compression system according to any one of claims 1-20, wherein the wearable garment is flexible.

22. The compression system according to any one of claims 1-21, wherein the body region comprises: abdomen, lower back, buttocks, groins and / or hips.

23. The compression system according to any one of claims 1-22, wherein the body region is abdomen and the garment comprises six groups of inflatable chambers.

24. The compression system according to claim 23, wherein the garment is configured to be positioned over the abdomen region of the subject such that: a first group of inflatable chamber(s) is configured to be placed essentially above (superior to) naval region; a second and a third group of inflatable chamber(s), located on opposing lateral sides of the first group and configured to be placed essentially over left and right upper quadrants of the abdomen; a fourth group of inflatablechamber(s) configured to be placed essentially below (inferior to) naval region and superiorly to groin region of the subject; and a fifth and a sixth group of inflatable chamber(s), located on opposing lateral sides of the fourth group and configured to be placed essentially over left and right lower quadrants of the abdomen.

25. The compression system according to any one of claims 1-24, wherein the symptoms are selected from: pain, tissue adherence, organ adherence, cysts, or any combination thereof.

26. The compression system according to any one of claims 1-25, for enhancing blood circulation in abdomen body region to thereby enhance condition and / or functionally of reproductive organs of the subject.

27. A method for providing a compression therapy to a body region of a subject afflicted with a condition selected from endometriosis or adenomyosis, the method comprising: placing the wearable garment of the compression system according to any one of claims 1-26, on the subject, such that the inflatable chambers of the compression sleeve are at least partially engageable with a body region of the subject; and controlling the pressure in the inflatable compression chambers, according to a spatial -temporal pattern, to provide a compression therapy to the body region and thereby at least partially alleviate symptoms associated with the condition.

28. The method according to claim 27, wherein controlling the pressure is facilitated using the control unit.

29. The method according to any one of claims 27-28, further comprising fastening or securing the wearable garment to the subject.

30. The method according to any one of claims 27-29, further comprising activating heating elements of the compression device, to thereby further provide heat therapy to the subject.

31. The method according to any one of claims 27-30, further comprising receiving, from the subject, user specific information, to thereby allow adjustment of the compression therapy.

32. The method according to any one of claims 27-31, wherein the compression therapy is configured to enhance localized or systemic blood circulation, facilitate separation of tissue and / or organ adherence thereto, stimulate nerve system and / or reduce localized or systemic pain levels of the subject.

33. The method according to any one of claims 27-32, wherein the condition is endometriosis, and the body region is abdomen.

34. The method according to any one of claims 27-33, for enhancing blood circulation in abdomen body region, to thereby enhance condition and / or function of reproductive organs of the subject.

Images