Body part thermal regulation and compression system

Abstract

The invention relates to a thermal regulation (10) and compression system for a part of a user's body (11), the system comprising: - a flexible pouch (12) intended to be applied to the user's body part, - a heat transfer circuit (14) connected to the flexible pouch (12) to supply the flexible pouch with a heat transfer fluid, - a supply unit (16) in fluid communication with the flexible pouch through the heat transfer circuit, said supply unit comprising a thermal generator configured to regulate the temperature of the heat transfer fluid and a pump configured to move and pressurize the heat transfer fluid in the heat transfer circuit, - a controller (28), characterized in that the controller is configured to control the pump so as to generate intermittent compression of the body part in contact with the flexible pouch. Figure for the abstract: Figure 3

Description

Title of the invention: Thermal regulation and compression system for a body part technical field

[0001] The present invention relates to a thermal regulation and compression system for a part of a user's body. Technological background

[0002] There are systems for regulating a user's body temperature by applying cold to a limb, such as a leg or arm, to improve recovery after physical activity. These systems generally include a fabric sleeve into which a pocket is inserted. This pocket is usually connected to a heat transfer fluid circuit cooled by a cold source, typically a reservoir into which the user places ice cubes.

[0003] These systems are simple to use and inexpensive because they only involve an external cold source, ice cubes, and generally do not regulate the temperature or do so with low precision.

[0004] These systems therefore do not allow for fine temperature regulation.

[0005] It is known that applying a cold compress to a limb, or more generally to a part of a user's body, following a medical procedure minimizes the use of analgesics and accelerates the user's recovery. Existing systems are not suitable for this post-operative application because thermal regulation is neither sufficiently reliable nor efficient for use in such a high-risk situation.

[0006] Moreover, these systems cannot generally be used in a hospital setting considering the safety constraints and compliance with the required regulatory standards.

[0007] There is therefore a need for a thermal regulation and compression system for a part of a user's body that allows for greater reliability and efficiency, while being compatible with post-operative use in a hospital setting. Summary of the invention

[0008] To this end, the invention proposes a thermal regulation and compression system for a part of a user's body, the system comprising: - a flexible pouch designed to be applied to the user's body, - a heat transfer circuit connected to the flexible pouch to supply the flexible pouch with a heat transfer fluid, - a fluid communication supply unit with the flexible pouch through the heat transfer circuit, said supply unit comprising a thermal generator configured to regulate the temperature of the heat transfer fluid and a pump configured to move and pressurize the heat transfer fluid in the heat transfer circuit, - a controller to control the operation of the thermal generator and the pump, characterized in that the controller is configured to control the pump in such a way as to generate intermittent compression of the part of the body in contact with the flexible pouch.

[0009] The thermal regulation and compression system combines a thermal regulation function on the user's body part, notably by cooling it, with an intermittent compression function to improve the user's healing. These functions are controlled by a controller that allows for guided regulation and compression, thus making it more reliable.

[0010] Intermittent compression means applying an intermittent compression force to the part of the user's body located inside the flexible pouch.

[0011] The term "intermittent" refers to the fact that the compression applied to the user is controlled to be discontinuous. Thus, a compression force is applied at a predetermined pressure value for a predetermined compression time. The regulation and compression system is therefore configured to alternate cycles of compression and decompression of the part of the user's body located in the flexible pouch.

[0012] "Decompression" means that, during a decompression cycle, the value of the compression force applied by the bag on the user's body part is less than the value of the compression force applied by the bag on the user's body part during a compression cycle. The value of the compression force during a decompression cycle may be zero.

[0013] Intermittent compression is a technique used mainly in the medical field, particularly for the treatment of circulatory disorders such as venous insufficiency, lymphedema, and to prevent the formation of deep vein thrombosis (DVT).

[0014] Intermittent compression consists of applying controlled and cyclical pressure to a part of the body, generally the lower limbs, using deformable devices such as inflatable sleeves, in this case a flexible pouch. These deformable devices are connected to a pump that controls inflation and deflation, thus creating pressure that is released in cycles.

[0015] During the compression phase, the pump inflates the flexible pouch, which exerts pressure on the limbs. This pressure helps force blood or lymph back towards the heart, thus improving blood or lymphatic circulation.

[0016] During the decompression phase, the pressure is released after a predetermined time, allowing blood to flow back into the blood vessels naturally. This alternation between compression and decompression stimulates circulation.

[0017] Intermittent compression is generally used for the following applications: - Prevention of deep vein thrombosis (DVT): In hospital settings, particularly after surgery or for bedridden patients, intermittent compression is used to prevent the formation of blood clots. - Treatment of edema and lymphedema: By increasing lymphatic flow, it helps reduce fluid accumulation in tissues and relieves edema. - Chronic venous insufficiency: For all patients suffering from varicose veins or venous insufficiency, this technique helps improve venous return and reduce symptoms such as pain, fatigue, and swelling. - Improved recovery: In the field of sports, intermittent compression is used to aid muscle recovery by increasing blood flow and eliminating metabolic waste more quickly after intense physical exertion.

[0018] Intermittent compression has the advantage of being non-invasive and simple because it does not involve surgery. Furthermore, it greatly improves user comfort because it provides rapid relief from symptoms related to poor blood circulation, such as edema and pain.

[0019] Providing a system that enables intermittent compression in combination with thermal regulation improves the effectiveness of the healing process. Furthermore, the system controller allows for reliable and safe thermal regulation and controlled compression.

[0020] The heat transfer circuit includes, for example, a supply line for the flexible bag containing the heat transfer fluid. This supply line extends from the supply unit to the flexible bag. The heat transfer circuit also preferably includes a discharge line for the heat transfer fluid from the flexible bag. This discharge line extends from the flexible bag to the supply unit.

[0021] The supply and discharge lines are connected respectively to the flexible bag and the supply unit by means of fluid connectors, preferably removable to facilitate transport and installation of the system.

[0022] The heat transfer circuit, together with the flexible pouch and the power supply unit, forms a closed thermal regulation loop. The pump sets the heat transfer fluid in motion within the heat transfer circuit, and thus within this closed loop. The heat generator regulates the temperature of the heat transfer fluid and therefore the temperature of the part of the body placed within the flexible pouch.

[0023] The thermal generator preferably comprises a module using the Peltier effect. The generator may also include a watercooling system.

[0024] The controller preferably includes a pump speed regulation module.

[0025] The controller is preferably configured to control at least three levels of intermittent compression: light pressure, moderate pressure and high pressure.

[0026] Light pressure corresponds to a user's body pressure range of 30 to 40 mmHg. This mode is generally used for the prevention of deep vein thrombosis in low-risk users or for the mild relief of edema.

[0027] Moderate pressure corresponds to a user's body pressure range of 40 to 60 mmHg. This mode is generally used for users with moderate venous insufficiency or more pronounced edema.

[0028] High pressure corresponds to a user's body pressure range of 60 to 80 mmHg. This mode is generally used in more serious cases, such as severe lymphedema or specific post-operative situations. High pressure is applied with caution to avoid complications.

[0029] Before prescribing intermittent compression, several clinical factors must be evaluated, including: - the patient's medical condition: the nature of the pathology (e.g., deep vein thrombosis, lymphedema, venous insufficiency) will influence the level of compression required; - Anatomy and vascular condition: the condition of the blood vessels, the presence of varicose veins or other vascular abnormalities, as well as the condition of the skin, are important factors; - the size and circumference of the affected body part: measuring the affected limbs or body parts is essential to choosing the correct size device and to adjust the pressure.

[0030] The controller is configured to selectively perform thermal regulation and / or compression. The controller is thus configured to control the thermal regulation and compression functions independently of each other.

[0031] According to one embodiment of the thermal regulation and compression system, the controller is configured to determine at least one operating parameter of the pump from among: a heat transfer fluid pressure value, a compression cycle duration, a decompression cycle duration, a compression and decompression cycle frequency, and a compression mode, and to control the pump so as to generate intermittent compression according to said at least one operating parameter. It is thus possible to regulate the intermittent compression performed by the system.

[0032] A compression cycle duration can be set between 30 seconds and 2 minutes. The decompression phase preferably follows the compression phase. The durations of the compression and decompression cycles can be adjusted together to maximize venous return without causing discomfort or pain.

[0033] According to one embodiment of the thermal control and compression system, the controller is configured to determine at least two operating parameters of the pump and control the pump to generate intermittent compression according to said at least two operating parameters. This allows for finer and more detailed control of the intermittent compression by the system. Said at least two operating parameters are preferably the heat transfer fluid pressure value and the compression cycle time.

[0034] According to one embodiment of the thermal regulation and compression system, the flexible pouch is arranged to form a plurality of elementary cavities, separated from each other by at least one wall and being in fluid communication with each other to allow circulation of the heat transfer fluid through the flexible pouch from a fluid inlet to a fluid outlet, the fluid inlet and outlet being in fluid communication with the heat transfer circuit.

[0035] The plurality of cavities defines a heat transfer fluid receiving volume. Fluid connectors are formed on either side of the cavity network to supply the receiving volume with heat transfer fluid or to drain the heat transfer fluid from this receiving volume.

[0036] According to one embodiment of the thermal regulation and compression system, the elementary cavities are arranged so as to repeat periodically. Thus, the spatial distribution of the heat transfer fluid is more homogeneous, resulting in more homogeneous heat exchange with the user's body. Furthermore, the periodic repetition of the cavities simplifies the manufacturing of the pouch.

[0037] The flexible pouch preferably forms a two-dimensional or three-dimensional network of cavities.

[0038] When the network is two-dimensional, the plurality of cavities extends in the same cavity plane when the pouch is laid flat against a flat support. Thus, the cavities are in fluid communication with one or more adjacent cavities in this same cavity plane. The cavities are preferably aligned along a first and a second direction perpendicular to each other and contained within the cavity plane.

[0039] When the network is three-dimensional, the plurality of cavities extends in the same cavity plane as well as in an additional direction extending perpendicularly to the cavity plane. The cavities are preferably aligned along a first, a second, and a third direction perpendicular to each other and contained within the cavity plane. The third direction corresponds to the additional direction.

[0040] According to a preferred embodiment, the cavities form a three-dimensional, triply periodic gyroid network. This arrangement of the flexible pouch provides excellent diffusion of the heat transfer fluid within the flexible pouch and intermittent compression that is easily controlled by choosing the dimensions of the gyroid patterns.

[0041] The flexible pouch preferably has the general shape of a sleeve, i.e., a hollow cylinder. The flexible pouch is preferably open lengthwise so as to allow insertion of the user's body part, for example, a lower limb, into the flexible pouch. The system may further include a device for holding the flexible pouch in the closed position to improve the pouch's fit on the user and thus to enhance the efficiency of heat exchange and intermittent compression. The holding device may be an elastic strap to be placed around the flexible pouch. The holding device may be in the form of a harness for body parts such as the shoulder or head.

[0042] The flexible pouch is preferably of a shape complementary to a part of the user's body. This part of the user's body can be one of the following: a lower limb, an upper limb, a portion of the torso, a shoulder, the skull.

[0043] According to one embodiment of the thermal regulation and compression system, the flexible pouch is made of an elastic material that allows the pouch to undergo elastic deformation when supplied with pressurized heat transfer fluid, thereby generating intermittent compression of the body part to which the flexible pouch is applied. This elasticity allows the flexible pouch to conform in shape to the user's body part when the pouch is in contact with the user, thus improving heat exchange.

[0044] According to one embodiment of the thermal regulation and compression system, the elastic material is a silicone. In particular, the elastic material is a silicone compatible with additive manufacturing, i.e., three-dimensional printing.

[0045] The flexible pouch is preferably one piece, i.e. made of material.

[0046] According to one embodiment of the thermal regulation and compression system, the flexible pouch is obtained by additive manufacturing.

[0047] According to one embodiment of the thermal regulation and compression system, it further comprises a control interface configured to receive a setpoint signal from a user and transmit to the controller a control signal based on said setpoint signal to modify at least one operating parameter of the thermal generator and / or the pump.

[0048] The control interface includes, for example, one or more of a screen, one or more control buttons, a communication module configured to receive said control signal from a device external to the system such as a telephone.

[0049] According to one embodiment of the thermal regulation and compression system, the power unit comprises a housing containing the thermal generator, the pump, and the controller. The power unit further comprises a start button for the thermal generator, the pump, and the controller, formed on an external wall of the housing and accessible by a user from outside the housing. The control interface is located inside the housing and is inaccessible to a user from outside the housing. This arrangement allows the system to be configured only at the factory, i.e., during a manufacturing or adjustment phase separate from the operating phase.

[0050] The system is therefore preferably configured prior to its use to ensure that the regulation and / or compression parameters remain unchanged for improved safety. The system can thus be configured for post-operative or sports applications. More specifically, the system can be configured according to the type of surgery the user has undergone, for example, surgery on a lower limb, an upper limb, the torso, or even the head.

[0051] According to one embodiment of the thermal regulation and compression system, the flexible pouch comprises a body in which the elementary cavities are formed, as well as a first and a second fluidic connectors forming respectively the inlet and outlet of fluid, the first and second fluidic connectors being integrally formed with the body.

[0052] The invention further proposes a method of thermal regulation and compression of a part of a user's body by means of the thermal regulation and compression system described above.

[0053] The process comprises the following steps: - determine at least one operating parameter of the pump, - determine at least one thermal regulation parameter, - control the thermal generator and the pump according to said at least one pump operating parameter and said at least one thermal regulation parameter. Brief description of the figures

[0054] The following description, with reference to the accompanying drawings, given by way of non-limiting examples, will clearly explain what the invention consists of and how it can be implemented. In the accompanying figures:

[0055] [Fig-1] Fig. 1 represents a first embodiment of a thermal regulation and compression system for a part of a user's body, in which a flexible pouch is arranged around one of the user's shoulders;

[0056] [Fig.2] Fig.2 represents a second embodiment of the thermal regulation and compression system for a part of a user's body, in which the flexible pouch is arranged around a lower limb of the user;

[0057] [Fig.3] Fig.3 represents a schematic view of the second embodiment of the system in which a power unit includes a pump, a thermal generator and a controller;

[0058] [Fig.4] Fig.4 represents a detailed schematic view of the flexible pouch comprising a plurality of cavities arranged in a network;

[0059] [Fig.5] The [Fig.5] represents an embodiment of the flexible pouch arranged in a gyroidal manner;

[0060] [Fig. 6] [Fig. 6] shows a view of a user wearing a first, second, and third different arrangement of the flexible pouch. Description of embodiment(s)

[0061] For the sake of clarity, the same references designating the same elements according to the state of the art and according to the invention are used for all figures.

[0062] The concept of the invention is described more fully below with reference to the accompanying drawings, in which embodiments of the concept of the invention are shown. In the drawings, the size and relative sizes of the elements may be exaggerated for clarity. Similar numbers refer to similar elements in all drawings. However, this concept of the invention can be implemented in many different forms and should not be interpreted as being limited to the embodiments set forth herein. Instead, these embodiments are proposed so that this description is complete and communicates the scope of the concept of the invention to those skilled in the art.

[0063] A reference throughout the specification to "an embodiment" means that a particular feature, structure, or characteristic described in relation to an embodiment is included in at least one embodiment of the present invention. Thus, the appearance of the phrase "in an embodiment" in various places throughout the specification does not necessarily refer to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Moreover, the term "including" does not exclude other elements or steps.

[0064] With reference to [Fig.1], the thermal regulation and compression system 10 for a part of a user's body 11 comprises a flexible pouch 12, a heat transfer circuit 14 and a power supply unit 16.

[0065] The flexible pouch 12 here has a complementary shape to a shoulder of the user 11. The flexible pouch 12 has a bent sleeve shape.

[0066] The flexible pouch 12 in [Fig. 2] has a shape complementary to a lower portion of a lower limb. The flexible pouch 12 has a cylindrical sleeve shape. A strap 18 is arranged around the flexible pouch 12 to hold it in position.

[0067] The heat transfer circuit 14 includes a supply line 20 and a discharge line 22 for the circulation of the heat transfer fluid between the supply unit 16 and the flexible bag 12.

[0068] With reference to [Fig.3], the power unit 16 includes a thermal generator 24, for example of the Peltier type, to regulate the temperature of the heat transfer fluid and a pump 26 to move and pressurize the heat transfer fluid in the heat transfer circuit 14.

[0069] The power supply unit 16 further includes a controller 28 for controlling the operation of the thermal generator and the pump.

[0070] With reference to [Fig. 4], an example of a flexible pouch is shown in a flat position. In other words, the flexible pouch has been flattened against a flat surface.

[0071] The flexible pouch 12 comprises a plurality of cavities 30 in fluid communication with each other to define a heat transfer fluid receiving volume. Fluid connectors 32 are formed on either side of the network of cavities to supply the receiving volume with heat transfer fluid or to drain the heat transfer fluid from this receiving volume.

[0072] Figure 5 illustrates an arrangement of the flexible pocket in the form of a three-dimensional gyroidal network. The cavities 30 are thus formed by a periodically repeated gyroidal pattern.

[0073] With reference to [Fig.5], three different arrangements of the flexible pouch 12 are illustrated: a first arrangement in complementary shape with a lower limb, a second arrangement in complementary shape with a shoulder and a third arrangement in complementary shape with the user's skull.

Claims

Demands

1. A thermal regulation (10) and compression system for a part of a user's body (11), the system comprising: - a flexible pouch (12) intended to be applied to the user's body part (11), - a heat transfer circuit (14) connected to the flexible pouch (12) to supply the flexible pouch (12) with a heat transfer fluid, - a supply unit (16) in fluid communication with the flexible pouch (12) through the heat transfer circuit, said supply unit (16) comprising a thermal generator (24) configured to regulate the temperature of the heat transfer fluid and a pump (26) configured to move and pressurize the heat transfer fluid in the heat transfer circuit (14), - a controller (28) for controlling the operation of the thermal generator (24) and the pump (26),characterized in that the controller is configured to control the pump (26) so as to generate intermittent compression of the part of the body in contact with the flexible pouch (12).

2. Thermal and compression control system (10) according to claim 1, wherein the controller (28) is configured to determine at least one operating parameter of the pump (26) from among: a heat transfer fluid pressure value, a compression cycle time, a decompression cycle time, a compression and decompression cycle frequency and a compression mode, and to control the pump (26) so as to generate intermittent compression according to said at least one operating parameter.

3. Thermal and compression regulation system (10) according to claim 2, wherein the controller (28) is configured to determine at least two operating parameters of the pump (26) and control the pump (26) so as to generate intermittent compression according to said at least two operating parameters.

4. A thermal regulation and compression system (10) according to any one of the preceding claims, wherein the flexible pouch (12) is arranged to form a plurality of elementary cavities (30), separated from each other by at least one wall and being in fluid communication with each other to allow circulation of the heat transfer fluid through the flexible pouch (12) from a fluid inlet to a fluid outlet, the fluid inlet and outlet being in fluid communication with the heat transfer circuit (14).

5. Thermal regulation and compression system (10) according to any one of the preceding claims, wherein the flexible pouch (12) is formed in an elastic material enabling the pouch to exhibit elastic deformation when the flexible pouch (12) is supplied with the pressurized heat transfer fluid so as to generate intermittent compression of the part of the body on which the flexible pouch is applied.

6. Thermal regulation (10) and compression system according to claim 5, wherein the elastic material is a silicone.

7. Thermal regulation and compression system (10) according to any one of the preceding claims, wherein the flexible pouch (12) is obtained by additive manufacturing.

8. Thermal regulation and compression system (10) according to any one of the preceding claims in combination with claim 4, wherein the elementary cavities (30) are arranged so as to repeat periodically to form a two-dimensional or three-dimensional lattice, preferably in the form of a triply periodic gyroid elementary pattern.

9. Thermal and compression control system (10) according to any one of the preceding claims, further comprising a control interface configured to receive a setpoint signal from a user and transmit to the controller (28) a control signal based on said setpoint signal to modify at least one operating parameter of the thermal generator (24) and / or the pump (26).

10. Thermal regulation and compression system (10) according to claim 9, wherein the power unit (16) comprises a housing receiving the thermal generator (24), the pump (26) and the controller (28), the power unit (16) further comprising a start-up button for the thermal generator (24), the pump (26) and the controller (28) formed on an external wall of the housing to be accessible by a user from outside the housing, the control interface being located inside the case so as to be inaccessible to a user from outside the case.

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