ES2956796T3 - Pressure application garment - Google Patents

Abstract

This pressure application garment (1) comprises three active parts (3, 4, 5), which are an abdominal active part (3) intended to surround the abdomen of the subject and two lower active parts (4, 5) each intended to to surround one of the lower extremities of the subject, each of the active parts (3, 4, 5) comprising at least one bladder (31, 41, 51) refillable with a fluid to obtain a homogeneous positive pressure applied by the active part to the entire corresponding body part of the subject between the abdomen and lower extremities. The pressure applying garment (1) comprises: - for each active part (3, 4, 5), at least one interface pressure sensor (2) configured to measure a pressure at the interface between the active part and the of the corresponding body of the subject while positioned between the active part and the corresponding body part of the subject, - a control unit comprising a receiver module configured to receive interface pressure measurements from one or more interface pressure sensors (2) of each active part (3, 4, 5), and a drive module configured to control, based on the interface pressure measurements received by the receiver module for each active part, at least one injection device to inject fluid in the one or more refillable bladders (31, 41, 51) of the active part, to maintain a predefined interface pressure value for said active part. (Automatic translation with Google Translate, without legal value)

Description

DESCRIPTION

Pressure application garment

field of invention

The invention relates to a pressure applying garment for applying pressure to the body of a subject, intended to apply pressure to the abdomen of the subject as well as the lower extremities of the subject. In particular, the invention relates to a pressure applying garment for applying pressure to the body of a subject in accordance with the principle of "lower body positive pressure" (LBPP), in order to allow revascularization of the brain by mobilizing the blood contained in the lower part of the subject's body. The present specification further describes a method, not forming part of the invention, for placing said pressure applying garment on a subject, and also a method, not forming part of the invention, for applying pressure to the body of a subject.

Background of the invention

The principle of “lower body positive pressure” (LBPP) involves applying constant low levels of pressure, which in particular are in the range of 10 to 40 mmHg, to both the abdomen and lower extremities of the subject, whereby the pressure applied to the abdomen is strictly less than the pressure applied to the lower extremities. This concept was initially developed to ensure adequate volume distribution in the infra- and supra-aortic zones, particularly for microgravity flights. LBPP has been documented to shift blood from the lower part of the body to the upper part, thereby increasing central cardiopulmonary blood volume.

WO2008104861A1 discloses the use of LBPP to treat individuals suffering from a vascular deficiency affecting the upper body, in particular a cerebral vascular deficiency or an eye disorder. This document describes the application of LBPP using anti-gravity pants or medical anti-shock pants (MAST), such as those sold by LIFE SUPPORT PRODUCTS INC, Saint Louis, Missouri, United States. These anti-shock medical pants comprise three independent air chambers that allow positive pressure to be applied respectively to the abdomen and the two lower extremities of a subject. Each of the air chambers is connected to a pneumatic end and is manually inflated using a pump, so a pressure gauge is provided in each air chamber to provide instantaneous pressure values.

US9554964 B1 discloses a differential pressure body suit with external support against body suit migration. Such a body suit may comprise a multi-layered suit fitted against the skin of a mammal to contain differential pressure, or a looser suit that flexes at the mammal's joints with minimal force. External support means include fixed or movable mechanical supports attached to the body suit, extraordinary levels of air pressure to rigidify the body suit. A cyclic control system can selectively activate and deactivate the differential pressure condition within the body suit to adapt to the movement of the mammal's legs.

An anti-shock medical pant has a rigid structure, which complicates its donning for bedridden subjects or for subjects suffering from paralysis of extremities, such as subjects who have suffered a stroke or cerebrovascular accident (CVA). In addition, anti-shock medical pants are usually available in one size, which does not suit all body shapes. However, if the morphology of a subject is not compatible with the size of the anti-shock medical pants, there is a risk that the pressure values indicated by the manometers do not correspond to the pressures actually applied to the parts of the subject's body. This makes the application of pressure to a subject's body unreliable. Implementation of LBPP with anti-shock medical pants further requires manual adjustment and monitoring of pressures over time in order to ensure that the pressures applied to the subject remain constant at each part of the body, which is time-consuming.

The more particular objective of the invention is to overcome these drawbacks by proposing a pressure application garment that allows homogeneous and constant pressure levels to be applied automatically, reliably and precisely, to the body parts of a subject.

Summary

To this end, the invention relates to a pressure application garment for applying pressure to the body of a subject, which comprises three active parts which are an abdominal active part intended to surround the abdomen of the subject and two lower active parts intended each one to surround one of the lower extremities of the subject, each of the active parts comprising at least one bladder refillable with a fluid to obtain a homogeneous positive pressure applied by the active part to the entire corresponding body part of the subject between the abdomen and the lower extremities, where the pressure application garment comprises:

- for each active part, at least one interface pressure sensor configured to measure a surface pressure at the interface between the active part and the corresponding body part of the subject while positioned between the active part and the body part corresponding to the subject,

- a control unit comprising a receiving module configured to receive interface pressure measurements from one or more interface pressure sensors of each active part, and a drive module configured to drive, based on the measurements of interface pressure received by the receiving module for each active part, at least one injection device for injecting fluid into one or more refillable bladders of the active part, to maintain a predefined interface pressure value for each active part, the value being predefined interface pressure value for the abdominal active part strictly less than the predefined interface pressure value for each lower active part.

A contribution of the invention is that the interface pressure taken into account by the control unit for each active part, which is measured by at least one interface pressure sensor placed between the active part and the corresponding body part of the subject , is representative of the pressure actually applied by the active part to the corresponding body part of the subject, which allows an automatic, reliable and precise application of pressure by the pressure applying garment according to the invention. On the contrary, if the pressure taken into account by the control unit for each active part is only the filling pressure of each bladder of an active part, measured in particular by means of a pressure gauge installed in a connecting tube between the bladder and a injection device for injecting liquid into the bladder, control of the applied pressure is unreliable because the filling pressure of a bladder is not systematically representative of the pressure actually applied by the bladder on the corresponding part of the subject's body, which It depends on the degree of fit of the garment around the subject's body.

According to one characteristic, the control unit is configured to maintain:

- for the abdominal active part, a first predefined interface pressure value that is in the range of 10 to 20 mmHg, preferably equal to about 10 mmHg,

- for each of the two lower active parts, a second predefined interface pressure value that is in the range of 20 to 40 mmHg, preferably equal to approximately 20 mmHg,

the first predefined interface pressure value for the abdominal active part being strictly less than the second predefined interface pressure value for each lower active part.

The pressure applying garment according to the invention is thus configured to automatically apply pressure to the body of a subject in accordance with the principle of "lower body positive pressure" (LBPP), creating a pressure gradient between the abdomen on the one hand and the lower extremities on the other hand, in order to allow revascularization of the brain by mobilizing the blood contained in the lower part of the subject's body. More specifically, the pressure applying garment according to the invention allows the brain to be passively revascularized by increasing the volume of circulating plasma. The control unit allows automatic control of the interface pressure and servo control of fluid injection into one or more bladders of each active part based on the interface pressure measurements and the interface pressure set point, ensuring the application constant pressure throughout the session, without manual intervention.

It should be noted that the therapeutic step band for the application of the LBPP regimen should be in the range of 20 to 40 mmHg in the lower extremities, without exceeding 40 mmHg. More specifically, it has been seen that above 40 mmHg, the increase in cardiac preload (or filling pressure of the heart) is so great that it stimulates the sympathetic nervous system, which has a reflex action on the vascular tone of the pathways. large arteries, which produces vasodilation and reduction in blood pressure. This produces, in particular, in subjects who have suffered a stroke, reduced cerebral perfusion, since cerebral autoregulation has ceased as a consequence of the stroke. Therefore, applying a pressure value greater than 40 mmHg to the lower extremities is harmful. Under these conditions, the pressure applying garment according to the invention is configured to maintain a second predefined interface pressure value less than or equal to 40 mmHg for each of the two lower active parts.

According to one feature, the control unit is configured to receive representative measurements of the subject's blood pressure, in particular taken continuously during the treatment session, and to control the or each injection device to inject fluid into the one or more refillable bladders of the active lower parts to maintain the blood pressure values of the subject below predefined thresholds, in particular to maintain the systolic blood pressure (SBP) strictly below 220 and the diastolic blood pressure (DBP) strictly below 120.

According to one feature, the control unit is configured to receive measurements representative of the intracerebral blood flow of the subject, in particular obtained by transcranial Doppler, and to correlate the change in the representative measurements of the intracerebral blood flow with the pressure gradient applied to the body parts of the subject using the pressure applying garment. This configuration advantageously allows a clinician to select a therapeutic goal, for example, aiming for an average 30% increase in intracerebral blood flow compared to that at the start of the treatment session. In this way, an alert can be created when said therapeutic objective has been reached, through which the practitioner decides whether or not to continue the session based on the functional results obtained.

The provision of interface pressure sensors for each of the three active parts allows control of the pressure values effectively applied to the abdomen and lower extremities of the subject, whereby each interface pressure sensor is placed directly between the active part and the corresponding body part of the subject. In particular, in the case of LBPP, the pressure applied to the abdomen advantageously has a value between 10 and 20 mmHg, preferably equal to approximately 10 mmHg, and the pressure applied to each lower extremity advantageously has a value that is in the range of 20 to 40 mmHg, preferably equal to about 20 mmHg. Control by interface pressure sensors further ensures that the applied pressures remain constant on each part of the subject's body throughout the entire pressure application session, which in particular lasts approximately 90 minutes in the case of LBPP.

Preferably, each active part of the pressure applying garment comprises a single refillable bladder in order to simplify the design of the garment. For each active part, the number and arrangement of interface pressure sensors are adequate to provide pressure measurements representative of the pressure actually applied to the subject's body part, in particular preventing the positioning of sensors on bony parts.

By way of example, in a specific embodiment:

- the active abdominal part of the pressure application garment comprises three interface pressure sensors, comprising an anterior central sensor intended to be placed in front of the center of the abdomen, and two lateral sensors intended to be placed on the sides of the abdomen;

- each lower active part of the pressure applying garment comprises three to five interface pressure sensors, comprising one or two lower sensors intended to be placed on the calf, in particular a rear lower sensor on the back side of the calf and possibly a lower medial sensor on the medial aspect of the calf, and two or three upper sensors intended to be placed on the thigh, in particular an upper posterior sensor on the posterior aspect of the thigh, an upper medial sensor on the medial aspect of the thigh and eventually a superior anteromedial sensor on the anteromedial aspect of the thigh.

The size, and more particularly the measuring surface, of each interface pressure sensor may differ from one sensor to another, in particular depending on its location. Thus, as an example, for the abdominal active part, the anterior central sensor can be chosen to have a measuring surface area that is larger than the measuring surface area of the lateral sensors.

According to one aspect of the invention, for each refillable bladder, the volume intended to receive fluid is delimited by a flexible layer impermeable to said fluid, which in particular has a base of textile and/or plastic material. Preferably, the waterproof layer material has elasticity properties which can be obtained, for example, by incorporating elastane into the layer material or, in the case of a layer comprising a woven textile, by weaving the textile. Advantageously, the material of the waterproof layer is selected in such a way that it can be washed on the outer surface thereof, that is, the surface of the bladder facing outwards.

In one embodiment, the fluid filling each bladder is air, whereby the flexible layer delimiting the volume of each bladder is thus airtight in a given pressure range, compatible with the air pressures that will be imposed on the bladder with the in order to exert the required positive pressure on the subject's body. Such a hermetic layer may in particular be a layer of plastic material, either self-supporting or deposited on a substrate. In particular, the airtight layer may comprise the superimposition of a woven or non-woven textile layer, in particular having a nylon, polypropylene, polyester, polyamide or cotton base, and a covering layer, in particular having a polyurethane base. , silicone, polyvinyl chloride (PVC) or other plastic material base. Preferably, the weight per unit area of the textile layer is in the range of 150 to 250 g/m2. An example of a material that can be used to form the airtight layer within the scope of the invention comprises a woven nylon layer, one side of which is coated with a polyurethane coating layer. Thanks to the tightness of the flexible layer that forms each of the bladders, no air chamber is necessary, since the bladder itself acts as an air chamber. This results in a flexible structure of each refillable bladder, which improves the wearing comfort of the pressure applying garment and facilitates its placement on a subject, including a bedridden or paralyzed subject.

Advantageously, each active part is a flexible part that can transition between a deployed configuration, allowing its placement around the corresponding body part of the subject, and a fitted configuration where it fits around the corresponding body part of the subject. In the fitted configuration, the active part is tubular in shape and the inward facing wall is capable of applying positive pressure to the subject's body part.

According to one embodiment, each active part is a part that has a base of textile and/or plastic material that comprises a first portion and a second portion superimposed on each other and impermeable to said fluid, which define between them the volume to receive the fluid from each refillable bladder. In the adjusted configuration of the active part on the corresponding part of the subject's body, the first portion is directed inward, while the second portion is directed outward. Advantageously, the first and second portions are connected between yes by means of a peripheral seam that is impermeable to said fluid, or by any other peripheral connection means that is impermeable to said fluid.

According to an advantageous feature, each interface pressure sensor is rigidly fixed to the inner wall of the active part, that is, to the wall that is intended to be directed towards the corresponding body part of the subject. In particular, the interface pressure sensor can be housed in a compartment provided for this purpose in the inner wall of the active part. Alternatively, the interface pressure sensor may be rigidly fixed to the inner wall of the active part by any other appropriate means, in particular by sewing or bonding, etc.

Advantageously, each refillable bladder of the pressure applying garment comprises at least one filling end piece designed to connect to a fluid injection device. For each refillable bladder, the pressure applying garment is further provided with at least one fill pressure sensor to detect the pressure at which the bladder is filled with fluid, such as a pressure gauge. In particular, for each refillable bladder, said fill pressure sensor may be installed in a connecting tube between a filling end piece of the bladder and the corresponding fluid injection device. Advantageously, the pressure applying garment comprises automatic servo control means between one or more filling pressure sensors and one or more interface pressure sensors of each active part. In particular, one or more filling pressure sensors of each active part can be connected to the control unit in such a way that an automatic servo control system can be configured between the filling pressure sensors and the interface pressure sensors. each active part in order to obtain a constant and controlled pressure applied to each part of the subject's body during the duration of a pressure application session. In the case of LBPP, the principle involves the mobilization of blood in the lower part of the body, which must be constant, controlled and self-regulated in order to compensate for losses, without being too high in order to prevent harmful effects. This constant and controlled mobilization of blood requires the application of constant, controlled and self-regulated pressure to each part of the subject's body throughout the session.

Within the scope of the invention, the injection device for injecting fluid into one or more refillable bladders of each active part of the pressure applying garment may be a pump, or a compressed air delivery system such as those available in the invention. hospitals. In an advantageous embodiment, the injection device for injecting fluid into one or more refillable bladders of each active part of the pressure application garment is a portable device, which allows the pressure application garment to be used during the transport of a subject. . In one embodiment, the injection device for injecting fluid into one or more refillable bladders of each active portion of the pressure applying garment is a portable pump incorporated into the garment.

According to an advantageous embodiment, each interface pressure sensor is a pneumatic sensor connected in a sealed manner to a measurement module, in particular by means of a flexible tube. The use of such a pneumatic sensor has the advantage of limiting the electronics that must be integrated directly into the active parts of the pressure applying garment. In particular, the pneumatic sensor may be a sensor as disclosed in patent document WO2009072011A1, which comprises a cushion having a flexible polymer shell, for example silicone, capable of receiving, in its interior volume, a predetermined volume of injected air corresponding to a known positive pressure. The measurement module comprises a pressure gauge and an air injection piston, which are in fluid communication with each other and with the pneumatic sensor. The measurement module of each sensor is configured to transmit pressure measurements from the interface to the receiving module of the control unit. This data transmission can be carried out by any means, in particular by wired connection means or by wireless means such as Bluetooth or WiFi. Advantageously, the measurement module of each pressure sensor is integrated into a control unit housing.

Alternatively, each interface pressure sensor may be an electronic sensor, in particular a sensor that measures a force applied to a surface at the interface between the active part and the corresponding body part of the subject, from which a pressure is calculated. of interface. Each electronic sensor is configured to transmit pressure values from the interface to the receiving module of the control unit. This data transmission is preferably carried out through wireless connection means such as Bluetooth or WiFi.

According to one aspect of the invention, each active part comprises adjustment means for adjusting the active part around the corresponding body part of the subject, to adopt, as best as possible, the shape of the corresponding body part of the subject and obtain the most effective and homogeneous application of pressure possible to the subject's corresponding body part.

According to one feature, for each active part, the adjusting means comprises shaping elements of the active part, capable of applying the active part against the corresponding body part of the subject when filling the or each refillable bladder of the active part.

The shaping elements of each active part allow the active part to be shaped in the filled state in such a way that it is pressed against the corresponding body part of the subject and a controlled and predictable surface pressure is applied thereto. This thus prevents any “buoyant” effect when filling each active part, so the active part is inflated without applying controlled and uniform pressure to the subject's body part.

In the particular example of LBPP, the specific modeling of the pressure application garment according to the invention allows the required pressure values to be applied in a reliable and controlled manner, that is, a pressure applied to the abdomen that has an advantageously understood value. in the range 10 to 20 mmHg, preferably equal to approximately 10 mmHg, and a pressure applied to each lower extremity having a value advantageously within the range of 20 to 40 mmHg, preferably equal to approximately 20 mmHg.

In the case where each active part of the pressure applying garment comprises a single refillable bladder, the presence of the shaping elements of each active part is even more important, in order to adopt the shape of the corresponding body part. of the subject when the refillable bladder of the active part is filled, and to obtain a homogeneous application of pressure, in particular for the lower active parts which have a large filling volume.

According to one characteristic, for each active part of the pressure applying garment, the modeling elements comprise at least one sculptural line of the layer that delimits the fluid receiving volume of each refillable bladder of the active part, in particular a sewing, which requires shaping the active part in the filled state in order to adopt the shape of the corresponding body part of the subject. Collectively, the shaping elements comprise raised shapes of the active part, capable of applying or pressing the active part against the corresponding part of the subject's body when filling the or each refillable bladder of the active part. The relief modeling can be sculptural seams or thermofusion of the flexible layer based on textile and/or plastic material that forms one or more bladders of the active part.

The adjustment means are designed to adjust each active part of the pressure applying garment around the corresponding body part of the subject, in order to adopt, as best as possible, the shape of the corresponding body part of the subject and obtain the most effective way and the most homogeneous application of pressure possible. In the adjusted configuration, the active part generally has a tubular shape.

According to one characteristic, the adjustment means comprise closing elements of the active part, which allow the adjustment of the circumference of the active part around the corresponding body part of the subject, preferably in an adapted manner along the length. of the tubular active part. According to a specific embodiment, the closure elements comprise at least one pair of gripping strips, comprising a first strip provided with hooks and a second strip provided with loops, which extend along the active part. Alternatively, or in combination with them, the closure elements may comprise various tensioning tape and clip systems distributed along the active part.

According to one feature, the lower active portions of the pressure applying garment are connected to the abdominal active portion to facilitate placement of the garment on the subject's body. According to a characteristic of the invention, each lower active part comprises, at its end opposite to the abdominal active part, a plurality of segments capable of folding one over another in order to adapt the length of the lower active part to the length of the corresponding lower extremity of the subject. Similarly, the abdominal active part may comprise, at one end, a plurality of segments capable of being folded on top of each other in order to adapt the length of the abdominal active part to the length of the subject's abdomen. Preferably, for each active part, in the state where the segments are folded on top of each other, the portion of the refillable bladder corresponding to the folded segments is not filled with fluid. In order to further increase the adaptability of the pressure application garment to the morphology of each subject, the presence of segments that can be folded or rolled can be combined with the provision of different garment sizes, for example S, M , L, XL.

According to one aspect of the invention, at least one of the lower active parts of the pressure applying garment comprises an inner tensioning element which, when the lower active part is positioned around the lower extremity of the subject, is capable of surround the subject's thigh and apply a tensing force. The inner tensioning element can thus act as a tourniquet, causing venous occlusion in the subject's thigh. Preferably, the internal adjustment element is a cuff intended to be inflated to a standardized pressure (50 mmHg). The application of a venous occlusion in the thigh of the subject using the internal tensioning element is advantageously combined with a measurement of the variations in the volume of the lower extremity as a result of this occlusion and its release, in order to evaluate the volume of mobilizable blood (or “venous bed”).

In the event that the estimate of the volume of mobilizable blood is zero or less than a predefined value, an injection of fluid into the venous network, in particular 500 mL of normal saline, can be performed before the application session. pressure using the pressure applying garment according to the invention.

Different plethysmography techniques can be used to measure variations in lower extremity volume, in particular aerial plethysmography, for example by measuring variations in air pressure in the lower active part of the pressure-applying garment that forms a sleeve. filled with air around the subject's lower extremity. More specifically, the implementation principle is as follows: the inner tension member surrounding the subject's thigh is inflated to achieve venous occlusion in the subject's thigh; the subject's lower extremity is thus distended as a result of the blockage of venous return; The thigh tourniquet is then released, and the subject's lower extremity recovers its initial volume as the venous return resumes normal flow. The variation in the volume of the lower extremity provides an estimate of the volume of mobilizable fluid, which includes the lymph and venous blood. Advantageously, the pressure application garment according to the invention not only allows obtaining venous occlusion by means of the internal tensioning element of the lower active part, but also the measurement, by means of aerial plethysmography, of the difference between the volume of the lower extremity at rest and the volume of the lower extremity a few minutes after the application of venous occlusion, directly using the lower active part of the pressure application garment, which forms a sleeve around the subject's lower extremity, and measuring the volume of air in this sleeve before and after application of venous occlusion.

According to an advantageous feature, the pressure-applied garment comprises a protective fabric, capable of being replaced with each use of the garment, which is removably attached to the inner wall of one or each active part of the garment. , that is, the wall of the active part that faces inward in the configuration in which the active part fits around the corresponding body part of the subject. The protective fabric acts as a “second skin”, preventing irritation of the subject's skin as a result of contact with the active part. The protective fabric also prevents the active part from getting dirty. Preferably, the protective fabric is provided on the inner wall of each active part, while being tensioned, and is kept tensioned by any appropriate means, such as gripping strips or other means. More specifically, it is important to prevent possible folds in the protective tissue during a pressure application session, in particular LBPP. Examples of textiles suitable for use as a protective fabric are microfiber textiles having a weight per unit area in the range of 40 to 170 g/m2.

The pressure applying garment as described herein above allows the implementation of a method, which is not part of the invention, for placing it on a subject, said method comprising steps in which:

- each active part of the pressure applying garment in the deployed configuration is placed in front of the corresponding body part of the subject;

- each active part of the pressure applying garment in the deployed configuration is placed in a tight configuration in which it fits around the corresponding body part of the subject;

- each refillable bladder of the pressure applying garment is filled with fluid until a measurement is obtained, for each active part, from each interface pressure sensor of the active part that is substantially equal to a predefined interface pressure value for said active part.

In the case of a subject for whom donning the pressure applying garment can only occur with the subject in a reclining position, the method of donning the pressure applying garment, as described above, comprises steps in which:

- the pressure applying garment is placed on a bed with each of the active parts in the deployed configuration;

- the subject lies face up on the pressure applying garment, while each part of the subject's body is placed on the corresponding active part of the garment;

- each active part of the pressure applying garment in the deployed configuration is placed in a tight configuration in which it fits around the corresponding body part of the subject;

- each refillable bladder of the pressure applying garment is filled with fluid until a measurement is obtained, for each active part, from each interface pressure sensor of the active part that is substantially equal to a predefined interface pressure value for said active part.

The pressure applying garment further allows the implementation of a method, which is not part of the invention, for applying pressure to the body of a subject according to a predetermined protocol, which includes a first predefined pressure value to be applied to the abdomen. of the subject and a second predefined pressure value to be applied to each of the lower extremities of the subject for a predefined time, using a pressure applying garment comprising three active parts, which are an abdominal active part intended to surround the abdomen of the subject and two lower active parts, each intended to surround one of the lower extremities of the subject, each of the active parts comprising at least one bladder refillable with a fluid to obtain a homogeneous positive pressure applied by the active part to the the entirety of the corresponding part of the subject's body between the abdomen and the lower extremities, the pressure applying garment comprising, for each active part, at least one interface pressure sensor configured to measure a pressure at the interface between the active part and the corresponding part of the subject's body, while being placed between the active part and the corresponding part of the subject's body, said method comprising steps in which:

- each active part of the pressure applying garment in the deployed configuration is placed in front of the corresponding body part of the subject;

- each active part of the pressure applying garment in the deployed configuration is placed in a tight configuration in which it fits around the corresponding body part of the subject;

- each refillable bladder of the pressure applying garment is filled with fluid until a measurement is obtained, for each active part, from each interface pressure sensor of the active part that is substantially equal to the predefined pressure value to be applied to the part of the subject's body that corresponds to said active part;

- during the predefined duration, for each active part, the interface pressure measurements received for each active part are used as a basis to drive at least one injection device to inject fluid into one or more refillable bladders of the active part, to maintain a measurement of each interface pressure sensor of the active part that is substantially equal to the predefined pressure value to be applied to the part of the subject's body that corresponds to said active part.

According to one version of the above-described method of applying pressure, the or each fluid injection device is automatically actuated by a control unit.

According to another version of the method of applying pressure described above, the default protocol is a LBPP treatment, where:

- the first predefined pressure value to be applied to the abdomen of the subject is in the range of 10 to 20 mmHg and is preferably equal to approximately 10 mmHg,

- the second predefined pressure value to be applied to each of the lower extremities of the subject is in the range of 20 to 40 mmHg and is preferably equal to approximately 20 mmHg,

- the first predefined pressure value for the abdominal active part is strictly less than the second predefined pressure value for each lower active part,

- the predefined duration is equal to about 90 minutes.

According to another version, the method of applying pressure described above comprises, prior to the step of filling each refillable bladder of the pressure applying garment with fluid to apply predefined pressure values to the body parts of the subject, a step of measuring the volume of mobilizable blood, which includes the application of a venous occlusion in one of the lower extremities of the subject and measuring, by means of plethysmography, the variations in the volume of said lower extremity as a result of said occlusion and the release thereof .

According to one characteristic, the venous occlusion is applied to the lower extremity of the subject through an interior tensioning element of one of the lower active parts of the pressure application garment, said interior tensioning element being, when the lower active part is in place around the subject's corresponding lower extremity, capable of encircling the subject's thigh and applying a tensioning force thereto.

According to one characteristic, the measurement of the volume variations of the lower extremity as a consequence of the occlusion and its release is carried out by means of aerial plethysmography, measuring the air pressure variations in the lower active part of the application garment. of pressure that forms an air-filled sleeve around the subject's lower extremity.

According to a feature, when the measured mobilizable blood volume is less than a predefined threshold, an injection of normal saline is carried out into the venous network of the subject, before applying the predefined pressure values to the body parts. of the subject through the pressure application garment, in order to increase the volume of mobilizable blood.

Description of the drawings

The features and advantages of the invention will become apparent from the following description of embodiments of a pressure applying garment, given merely by way of example and with reference to the accompanying drawings in which:

- Figure 1 is a front view of a pressure application garment according to a first embodiment of the invention;

- Figure 2 is a rear view of the pressure application garment of Figure 1;

- Figure 3 is a front view of the pressure application garment of Figure 1 with the active parts thereof in a deployed configuration;

- Figure 4 is a larger scale section view along plane IV-IV of Figure 3;

- Figure 5 is a front view of the pressure application garment of Figure 1 placed on a subject and connected to air injection devices;

- Figure 6 is a view similar to that of Figure 1 of a pressure-applied garment according to a second embodiment of the invention;

- Figure 7 is a view similar to that of Figure 5 for a pressure application garment according to a third embodiment of the invention, from which the air injection devices have been omitted for better visibility; and

- Figure 8 is a rear view of the pressure application garment of Figure 7.

Illustrative embodiments of the invention

As shown in Figures 1 to 5, the pressure applying garment 1 of the first embodiment comprises three active parts, that is, an abdominal active part 3, intended to surround the abdomen A of a subject, and two parts 4, 5 active lower ones, each one of which is intended to surround a leg, or lower limb L ₁ , L ₂ , of the subject. Each of the active parts 3, 4, 5 of the pressure applying garment 1 is a flexible textile part made of an airtight material. In particular, in this example, the sealing material of each active part 3, 4, 5 comprises a woven nylon textile layer coated, on one side, with a polyurethane coating layer. In order to facilitate the placement of the pressure-applying garment 1 on the body of the subject, the two lower active parts 4, 5 are connected to the abdominal active part 3 by connecting elements 9, which are, in particular, strips elastic textiles. Each active part 3, 4, 5 can be deformed between a substantially flat deployed configuration, shown in Figure 3, allowing its placement around the corresponding body part of the subject, and a tubular configuration, shown in the Figures 1, 2 or 5, where it is able to surround the corresponding body part of the subject and fit around it.

As shown for the active part 5 in the section view of Figure 4 (with the understanding that the active parts 3 and 4 have similar sections to those of the active part 5), each active part 3, 4, 5 of the garment 1 of pressure application comprises the superposition of an inner textile portion 33, 43, 53, intended to be oriented towards the body of the subject, and an outer textile portion 34, 44, 54, intended to be oriented outwards, both being made of a material airtight as described above. For each active part 3, 4, 5, the inner textile portion 33, 43, 53 and the outer textile portion 34, 44, 54 made of an airtight material are connected to each other by a peripheral seam 32, 42, 52, which It is also airtight. Thus, for each active part 3, 4, 5 of the pressure applying garment 1, an airtight bladder 31, 41, 51 is delimited between the inner textile portion 33, 43, 53 and the outer textile portion 34, 44, 54. , so the interior volume V of the bladder 31, 41, 51 is capable of being filled with air.

In this example, each active part 3, 4, 5 comprises a single refillable bladder 31, 41, 51, which has the advantage of simplifying the design of the pressure applying garment 1. However, alternatively, each active part 3, 4, 5 may comprise a plurality of refillable bladders. Each refillable bladder 31,41, 51 of the pressure applying garment 1 is intended to be filled with air in such a way that, in the adjusted configuration of the active part 3, 4, 5 on the corresponding body part of the subject, the portion 33, 43, 53 inner textile applies positive pressure.

Each refillable bladder 31, 41, 51 of the pressure applying garment 1 comprises a plurality of filling end pieces 36, 46, 56 distributed over the surface of the bladder in order to optimize filling thereof. As shown schematically in Figure 5, the filling end parts 36, 46, 56 of the active parts 3, 4, 5 are suitable for connecting to air injection devices 63, 64, 65. Different types of air injection devices can be used within the scope of the invention. In particular, each air injection device 63, 64, 65 may be a portable pump integrated into the garment 1, or a compressed air supply in a hospital. Each refillable bladder 31, 41, 51 is equipped with at least one pressure gauge 60 to measure the pressure at which the bladder is filled with air. Preferably, in order to measure the filling pressure in the different areas of each refillable bladder 31, 41, 51, a pressure gauge 60 is installed in each connecting tube between a filling end piece 36, 46, 56 of the bladder and the corresponding air injection device 63, 64, 65.

In order to control the pressure actually applied to the abdomen A of the subject by the abdominal active part 3 and to the lower extremities L ¹ , L ² of the subject by the lower active parts 4, 5, the garment 1 comprises interface pressure sensors 2 mounted on the inner textile portion 33, 43, 53 of each active part 3, 4, 5. Each sensor 2 is intended to measure a pressure at the interface between the active part 3, 4, 5 to which it is attached and the corresponding body part of the subject. Each sensor 2 can be sewn, for example, in a compartment provided for this in the corresponding interior textile portion 33, 43, 53. Alternatively, each sensor 2 may be rigidly fixed to the corresponding inner textile portion 33, 43, 53 by any other appropriate means, in particular by sewing or bonding, etc.

In an example embodiment, each interface pressure sensor 2 may be a pneumatic sensor as disclosed in patent document WO2009072011A1, comprising a flexible polymer cushion capable of receiving, in its interior volume, a predetermined volume of injected air. corresponding to a known positive pressure, the cushion being hermetically connected by a flexible tube (not shown) to a measurement module 72. The measurement module 72 of each sensor 2 comprises in particular a manometer and an air injection piston, which are in fluid communication with each other and with the pneumatic sensor 2. The use of such pneumatic sensors obviates the need for electronic components in the active parts 3, 4, 5 of the pressure applying garment 1, so the electronics are displaced in the measurement module 72 external to the textile parts. These pneumatic sensors also have the advantage of being compatible with the relatively low interface pressure levels sought in LBPP, which are in particular in the range of 10 to 40 mmHg. It goes without saying that, alternatively, the pressure applying garment 1 may comprise electronic interface pressure sensors, provided that the sensitivity of these electronic sensors is compatible with the interface pressure levels sought.

For each active part 3, 4, 5, the number and arrangement of the interface pressure sensors 2 are adequate to provide pressure measurements representative of the pressure actually applied to the subject's body part. By way of non-limiting example, in this embodiment, the abdominal active part 3 of the pressure applying garment 1 comprises three interface pressure sensors 2, that is, an anterior central sensor 2 intended to be placed in front of the center of the abdomen of the subject, and two lateral sensors 2 intended to be placed on the sides of the abdomen. Each lower active part 4, 5 of the pressure applying garment 1 comprises five interface pressure sensors 2, that is, a posterior lower sensor 2 intended to be placed on the back of the subject's calf, a medial lower sensor 2 intended to be placed on the medial aspect of the calf, an upper posterior sensor 2 intended to be placed on the posterior aspect of the subject's thigh, an upper medial sensor 2 intended to be placed on the medial aspect of the thigh, and an upper anteromedial sensor 2 intended to be placed on the anteromedial aspect of the thigh.

The pressure applying garment 1 comprises a control unit 7, shown in Figure 5, which may take the form of a casing capable of being attached to the surface of a textile part of the pressure applying garment 1, or to an element of furniture, such as a bed on which the pressure application session is carried out using the garment 1. In the case of pneumatic interface pressure sensors 2, the measurement module 72 associated with each The pneumatic interface pressure sensor of the pressure application garment 1 is advantageously integrated into the housing of the control unit 7, which further comprises a receiver module 70 configured to receive interface pressure measurements from the interface pressure module 72. measurement of each pneumatic interface pressure sensor. The connection between each measurement module 72 and the receiver module 70 may thus be wired or wireless. In the case of electronic type interface pressure sensors 2, each electronic interface pressure sensor is configured to transmit the interface pressure measurements directly to the receiving module 70 of the control unit 7, in particular by means of wireless connection means. . The one or more filling pressure gauges 60 of each refillable bladder 31, 41, 51 are also connected to the receiving module 70 of the control unit 7. In this way, an automatic servo system can be produced between the filling pressure sensors 60 and the interface pressure sensors 2 of each active part 3, 4, 5.

As shown in Figure 5, the receiving module 70 of the control unit 7 is also configured to receive:

- representative measurements of the blood pressure of the subject during the treatment session obtained, in particular continuously, using a blood pressure monitor 67 comprising a cuff placed on an arm of the subject; In particular, representative measurements of the subject's blood pressure include systolic blood pressure (SBP), diastolic blood pressure ( ^p A ^d ), mean arterial pressure;

- representative measurements of the intracerebral blood flow of the subject during the treatment session obtained, in particular continuously, by transcranial Doppler using a device 68 comprising a probe placed on the head of the subject, typically a 2 MHz Doppler probe, associated with a computing unit; In particular, representative measurements of the subject's intracerebral blood flow include peak systolic velocity (PSV), end diastolic velocity (EDV), resistance index, and area under the curve.

The control unit 7 further comprises a drive module 71, which is configured to drive one or more air injection devices 63, 64, 65 depending on:

- the interface pressure measurements received by the receiving module 70 for each active part 3, 4, 5, to maintain a predefined interface pressure set point for said active part;

- the representative blood pressure measurements of the subject received by the receiving module 70, to maintain the blood pressure values of the subject below predefined thresholds, in particular to maintain the systolic blood pressure (SBP) strictly below 220 and the diastolic blood pressure (DBP) strictly below 120:

- the representative intracerebral blood flow measurements of the subject received by the receiver module 70, to correlate the change in the representative intracerebral blood flow measurements of the subject with the pressure gradient applied to the body parts of the subject through the garment of application of pressure and/or associating representative measurements of the subject's intracerebral blood flow with a therapeutic objective, for example an average increase of 30% in intracerebral blood flow compared to that at the beginning of the treatment session, with the possibility of create an alert when said therapeutic objective has been reached, through which the practitioner decides whether or not to continue the session based on the functional results obtained.

The control unit 7 provides automatic control of the interface pressure, and servo control of the injection of air into the bladder 31, 41, 51 of each active part 3, 4, 5 as a function of the interface pressure measurements of sensors 2 and the predefined interface pressure set point for each active part. Therefore, it is possible to apply, in an automated manner, a constant and controlled pressure to each part of the subject's body during the entire duration of a pressure application session using the pressure application garment 1, without manual intervention.

In particular, according to an example, for the application of LBPP using the pressure applying garment 1, the predefined interface pressure set point for the abdominal active part 3 is 10 mmHg, and the pressure set point of predefined interface for each active part 4, 5 lower is 20 mmHg, whereby the garment 1 is advantageously configured to maintain the predefined interface pressure set point for each active part 3, 4, 5 for a duration of approximately 90 minutes .

In order to better adopt the shape of each part of the subject's body and obtain the most effective and homogeneous application of pressure possible to each part of the body, each active part 3, 4, 5 of the pressure applying garment 1 comprises means Adjustment button to adjust the active part 3, 4, 5 around the corresponding body part of the subject. In the example shown in Figures 1 to 5, these adjustment means comprise a pair of gripping strips on each active part 3, 4, 5, allowing the active part to close in the adjusted configuration around the part of the corresponding body A, L ₁ , L ₂ of the subject.

More specifically, in the example shown, each active part 3, 4, 5 comprises, along its entire length in the axial direction in the tubular configuration, a first grip strip 37, 47, 57 provided with hooks, which is located at a first longitudinal end of the active part, on the side of the outer textile portion 34, 44, 54, and a second grip strip 38, 48, 58 provided with loops, which is located at the second longitudinal end of the active part, this time on the side of the inner textile portion 33, 43, 53. The gripping strips 37, 38, 47, 48, 57, 58 allow the circumference of the active part 3, 4, 5 to be adjusted around the corresponding body part A, L ¹ , L ² of the subject in an adapted way along of the entire active part.

Each of the two lower active parts 4, 5 further comprises, opposite the abdominal active part 3, a rollable portion 45, 55, intended to adapt the length of the lower active part 4, 5 to the length of the limbs L ¹ , L ² lower of the subject and thus apply positive pressure to the lower L ¹ , L ² extremities in the most specific way possible. As shown in Figures 1 and 5, each rollable portion 45, 55 is formed by a plurality of segments S configured to fold on top of each other. Preferably, in the state where the segments S are folded on top of each other, the portion of the refillable bladder 41, 51 corresponding to the folded segments S cannot be filled with air.

As shown in Figure 3, the lower active part 4 of the pressure applying garment 1, which is intended to cover the right leg or lower right limb L ¹ of the subject, comprises an inner sleeve 40 which, when The lower active part 4 is in place around the right lower limb L ¹ of the subject, is capable of surrounding the right thigh of the subject and applying a tensioning force thereto. The tension cuff 40 may in particular be an inflatable cuff, comprising gripping strips in order to allow the cuff to be held in place around the thigh of the subject, and intended to be filled with air at a standardized pressure of approximately 50 mmHg. . The tension cuff 40 is intended to allow the subject's mobilizable blood volume (or "venous bed") to be assessed prior to performing a pressure application session, in particular LBPP, using the pressure application garment 1.

The procedure for evaluating the volume of mobilizable blood may advantageously comprise applying a venous occlusion to the right thigh of the subject using the tension cuff 40, and measuring the variations in the volume of the right lower extremity as a result of this occlusion and the release thereof, in particular by means of aerial plethysmography, measuring the air pressure variations in the lower active part 4 that forms a sleeve filled with air around the right lower limb L ¹ of the subject.

In the case of LBPP, the evaluation of the volume of mobilizable blood before a session of applying differential pressure of the LBPP using the pressure application garment 1 is important, since this volume determines the effectiveness of the LBPP treatment for the subject. In particular, when the volume of mobilizable blood in the lower part of the subject's body is low, there is a risk that the transfer of blood to the upper part of the subject's body as a result of the application of LBPP will not allow effective revascularization of the subject. brain. In such a case, it is advantageous to "fill" the venous network of the subject with a liquid, in particular with normal saline before the application of LBPP using the pressure application garment 1, in order to increase the volume of mobilizable blood. It is considered that, when the subject's mobilizable blood volume, evaluated as stipulated above, is zero or less than a predefined value, an injection of 500 mL of normal saline solution can advantageously be performed into the subject's venous network before of a LBPP session using pressure application garment 1.

Preferably, as shown in Figure 5, when placed on a subject, the pressure applying garment 1 comprises a disposable protective fabric 8 between the body of the subject and each of the active parts 3, 4, 5. The protective fabric 8, which is, for example, a microfiber fabric having a weight per unit area in the range of 40 to 170 g/m2, acts as a "second skin", preventing irritation of the skin of the subject as a result of contact with the active parts 3, 4, 5. Advantageously, the protective fabric 8 is applied in a manner removable on the inner textile portion 33, 43, 53 of each active part 3, 4, 5, while being kept tensioned by any appropriate means, for example using grip strips, to prevent the presence of folds that may irritate the skin of the subject. The protective fabric also prevents soiling of the active parts 3, 4, 5 in such a way that the pressure application garment 1 can be reused for different pressure application sessions without hygiene problems to the extent that the protective fabric 8 worn during a session is removed at the end of the session and replaced with a new protective fabric 8 for a subsequent session.

An example of a method of applying pressure according to the principle of “lower body positive pressure” (LBPP), on the abdomen A and lower extremities L ₁ , L ₂ of a subject, using garment 1 of applying pressure as described above, comprises steps as described below.

First, the pressure applying garment 1 is placed on the subject, preferably in a non-inflated state of the pressure applying garment, that is, a state in which each of the refillable bladders 31, 41, 51 of the garment is not filled with air or filled with very little air.

For this purpose, each active part 3, 4, 5 of the pressure applying garment 1 is placed in the deployed configuration thereof, as shown in Figure 3, and the protective textile 8 is applied over the portion 33, 43, 53 interior textile of each active part 3, 4, 5. The abdominal active part 3 of the pressure applying garment 1 is then placed at the level of the abdomen A of the subject, and the two lower active parts 4, 5 are each placed at the level of a lower limb L ¹ , L ² of the subject . Each active part 3, 4, 5 is then closed from its unfolded configuration to a tubular configuration around the corresponding body part of the subject, and tightened around the corresponding body part of the subject using strips 37, 38, 47. , 48, 57, 58 grip.

In the case of a bedridden subject or a subject suffering from paralysis of a limb, the design of the pressure application garment 1 allows it to be placed on the subject in a reclined position. In such a case, the pressure applying garment 1 is placed on a bed, with each of the active parts 3, 4, 5 thereof in the deployed configuration and provided with the protective fabric 8, then the subject is placed face up. above the pressure application garment 1, while the abdomen A of the subject is positioned at the level of the active abdominal part 3 and each of the lower extremities L ¹ , L ² of the subject at the level of the corresponding part 4 , 5 active lower garment pressure application. Then, each active part 3, 4, 5 is closed by moving from its deployed configuration to a tubular configuration around the corresponding body part of the lying subject, and is adjusted around the corresponding body part of the subject using the strips 37 , 38, 47, 48, 57, 58, gripping which have been provided in the front part of the pressure application garment for this purpose.

The measurement of the mobilizable blood volume can then be carried out for the subject equipped with the pressure application garment 1. To do this, a venous occlusion is applied to the root of the subject's right thigh using the tension cuff 40, and the variations in the volume of the right lower extremity L ¹ as a result of this occlusion and its release are measured by plethysmography. This may be, for example, aerial plethysmography, measuring variations in air pressure in the lower active part 4 which forms an air-filled sleeve around the right lower limb L ¹ of the subject. Depending on the value of the mobilizable blood volume thus evaluated, an injection of normal saline solution can be performed in the venous network of the subject in order to increase the volume of mobilizable blood and improve the effect of LBPP in case of hypovolemic venous bed. .

Each bladder 31, 41, 51 of the pressure applying garment 1 is then filled using air injection devices 63, 64, 65 connected to the filling end pieces 36, 46, 56 until a measurement is obtained for each active part 3, 4, 5 for each interface pressure sensor 2 of the active part that is substantially equal to the predefined interface pressure set point for said active part. In particular, according to an advantageous example of the application of LBPP using the pressure applying garment 1, the predefined interface pressure set point for the abdominal active part 3 is 10 mmHg, and the pressure set point of Predefined interface for each active lower part 4, 5 is 20 mmHg. The control unit 7 of the pressure applying garment 1 can be configured to fill the bladders 31, 41, 51 of the garment automatically.

The application of a constant and homogeneous pressure of 10 mmHg to the abdomen A of the subject and 20 mmHg to each of the lower extremities L ¹ , L ² of the subject for a given period, for example for a duration of 90 minutes, is performed then automatically by the pressure application garment 1 thanks to the garment control unit 7, which is configured to selectively operate the air injection devices 63, 64, 65 based on the interface pressure measurements of the sensors 2 to maintain, for the given duration, an interface pressure value measured by each sensor 2 that is equal to the predefined interface pressure set point for the active part 3, 4, 5 to which said sensor 2 is attached .

In the second embodiment shown in Figure 6, elements similar to those of the first embodiment are indicated with the same references. The pressure application garment 1 of this second embodiment differs from that of the first embodiment in that the adjustment means of the active parts 3, 4, 5 on the body of a subject are formed by a plurality of closure systems that use tensioning straps 37', 47', 57' and corresponding clips 38', 48', 58', instead of the gripping strips 37, 38, 47, 48, 57, 58. As shown in Figure 6, for each active part 3, 4, 5, the closure systems using tensioning straps 37', 47', 57' and clips 38', 48', 58' are distributed along the entire length of the active part in the axial direction in the tubular configuration, to allow adjustment of the circumference of the part 3, 4, 5 activates around the corresponding body part A, L ₁ , L ₂ of the subject in an adapted way along the entire active part.

In the third embodiment shown in Figures 7 and 8, elements similar to those of the first embodiment are indicated with the same references. The pressure applying garment 1 of this third embodiment differs from that of the first embodiment in that the adjustment means of the active parts 3, 4, 5 on the body of a subject are not limited to the strips 37, 38, 47 , 48, 57, 58 grip that close longitudinally. In this third embodiment, the adjustment means further comprise sculptural seams 39, 49, 59 of the textile of each active part 3, 4, 5. The seams 39, 49, 59 of each active part 3, 4, 5 are configured to impose a shape of the active part 3, 4, 5 that applies the active part against the corresponding body part A, L ₁ , L ₂ of the subject during filling of the refillable bladder 31, 41, 51 of the active part with air. The seams 39, 49, 59 of each active part 3, 4, 5 allow the active part to better adopt the shape of the corresponding body part of the subject. Furthermore, as shown in Figure 8, the pressure applying garment 1 of this third embodiment encompasses the buttocks of the subject. The part covering the buttocks of the subject may be a refillable part, capable of being filled with air, and in particular may correspond to a refillable bladder, to the extent that it may also be useful to apply constant and controlled pressure to the buttocks of the subject. to expel blood from this area. Alternatively, the part covering the subject's buttocks may not be fillable.

As shown in the previous examples, a pressure application garment according to the invention, comprising interface pressure sensors on the inner wall of each of the active parts thereof, allows homogeneous and constant pressures to be applied in a manner automatic in the abdomen and lower extremities of a subject. In particular, the pressure application garment according to the invention is well suited for the application of pressures according to the principle of "lower body positive pressure" (LBPP), which involves differential pressures applied to the abdomen and the lower extremities of a subject. Thanks to the tightness and flexibility of the textile that forms each of the active parts of the pressure application garment, each active part can act as an air chamber, while maintaining a flexible structure, which provides high comfort. use and facilitates its placement on a subject, including a bedridden or paralyzed subject. The possibility of providing the pressure applying garment of the invention in different sizes, for example S, M, L, XL and the presence of adjustment means to adjust the pressure applying garment to each part of the body further allow the garment adapts to the morphology of each subject, which contributes to the effectiveness of the garment for treatments using pressure application, in particular in accordance with the LBPP principle.

The invention is not limited to the examples described and illustrated. In particular, in the above examples, each active part 3, 4, 5 of the pressure applying garment comprises a single refillable bladder 31, 41, 51. Alternatively, the active parts of a garment according to the invention may each comprise any number of refillable bladders. Preferably, each refillable bladder of each active part is thus equipped with at least one interface pressure sensor. Furthermore, the number and arrangement of interface pressure sensors in each active part of a pressure applying garment according to the invention may be different from those described in the previous examples. The interface pressure sensors used can also be of different sizes, adapted to their location, and of different types, in particular pneumatic sensors, electronic sensors, or combinations of pneumatic and electronic sensors, etc. Finally the invention has been described above for the application of pressure corresponding to the principle of “lower body positive pressure” (LBPP). Alternatively, it can be used for the automatic application of all types of pressures to the abdomen and/or lower extremities of a subject, for example time-varying pressures, which can thus be automatically controlled by the pressure control unit. the pressure application garment.

The application of “Lower Body Positive Pressure” (LBPP) using a pressure applying garment according to the invention comprises the following treatments, without limitation:

Improvement of cerebral vascular recruitment in different clinical situations.

1- Acute phase of cerebral ischemia due to alteration of cerebral perfusion whatever the mechanism:

- Ischemic stroke

- Vasospasm.

2- Subacute phase of cerebral ischemia due to persistent deterioration of cerebral perfusion to improve functional recovery

- Ischemic stroke.

3- Chronic cerebral ischemia due to chronic alteration of cerebral perfusion

- In vascular dementia.

4- Improvement of ocular vascular recruitment in different clinical situations

- Acute phase of carotid occlusion.

- Anterior ischemic optic neuropathy (AION)

- Retinal artery occlusion

- Chronic impairment of choroidal perfusion.

- Age-related macular degeneration (AMD).

5- Use of LBPP to assist or increase the administration of a therapeutic agent for cerebral vascular deficiency selected from a group that includes anticoagulant agents, fibrinolytics, free radical scavenging agents, NO donors, in hypoperfused body areas.

6- Use of LBPP to assist or increase the administration of a therapeutic agent for ocular disorders selected from a group that includes antioxidants, anti-inflammatory agents, trophic factors, inhibitors of apoptosis and statins, in hypoperfused body areas.

Claims (12)

1. Pressure application garment (1) for applying pressure to the body of a subject, comprising three active parts (3, 4, 5), which are an abdominal active part (3) intended to surround the abdomen (A) of the subject. subject and two lower active parts (4, 5), each intended to surround one of the lower extremities (L ₁ , L ₂ ) of the subject, each of the active parts (3, 4, 5) comprising at least one bladder ( 31, 41, 51) refillable with a fluid to obtain a homogeneous positive pressure applied by the active part to the entire corresponding body part of the subject between the abdomen (A) and the lower extremities (L ¹ , L ² ), comprising the pressure application garment (1): - for each active part (3, 4, 5), at least one interface pressure sensor (2) configured to measure a pressure at the interface between the active part (3, 4, 5) and the corresponding body part of the subject while being positioned between the active part (3, 4, 5) and the corresponding body part of the subject, - a control unit (7) comprising a receiver module (70) configured to receive interface pressure measurements from one or more interface pressure sensors (2) of each active part (3, 4, 5). , and a drive module (71) configured to drive, based on the interface pressure measurements received by the receiving module for each active part, at least one injection device (63, 64, 65) to inject fluid into a or more refillable bladders (31, 41, 51) of the active part, to maintain a predefined interface pressure value for each active part, the predefined interface pressure value for the abdominal active part (3) being strictly less than the predefined interface pressure value for each lower active part (4, 5). 2. Pressure application garment according to claim 1, wherein the control unit (7) is configured to maintain: - for the abdominal active part (3), a first predefined interface pressure value that is in the range of 10 to 20 mmHg; and - for each of the two lower active parts (4, 5), a second predefined interface pressure value that is in the range of 20 to 40 mmHg. 3. Pressure application garment according to any one of claim 1 or claim 2, wherein the control unit (7) is configured to receive measurements representative of the blood pressure of the subject, and to control the or each device ( 64, 65) for injecting fluid into the one or more refillable bladders of the lower active parts (4, 5), to maintain the subject's blood pressure values (SBP, DBP) below predefined thresholds. 4. Pressure application garment according to any one of the preceding claims, wherein the control unit (7) is configured to receive representative measurements of the intracerebral blood flow of the subject, in particular obtained by transcranial Doppler, and to correlate the change in representative measurements. of the intracerebral blood flow with the pressure gradient applied to the parts of the subject's body (A, L ¹ , L ² ) through the pressure application garment (1). 5. Pressure application garment according to any one of the preceding claims, wherein, for each refillable bladder (31, 41, 51), the volume (V) to receive fluid is delimited by a layer (32-34, 42-44, 52 54) flexible that is impermeable to said fluid, in particular that has a base of textile and/or plastic material. 6. Pressure application garment according to any one of the preceding claims, wherein each interface pressure sensor (2) is rigidly fixed to the wall (33, 43, 53) of the part (3, 4, 5 ) active that is intended to be directed toward the subject's body part. 7. Pressure application garment according to any one of the preceding claims comprising, for each refillable bladder (31, 41, 51), at least one filling pressure sensor (60) to detect the pressure at which it is fills the bladder with fluid, and automatic servo control means between the one or more filling pressure sensors (60) and the one or more interface pressure sensors (2) of each active part (3, 4, 5). 8. Pressure application garment according to one of the preceding claims, wherein each interface pressure sensor (2) is a pneumatic sensor hermetically connected, in particular by a flexible tube, to a pressure module (72). measurement. 9. Pressure application garment according to any one of the preceding claims, wherein each active part (3, 4, 5) comprises means (37, 38, 39, 47, 48, 49, 57, 58, 59) adjustment means for adjusting the active part around the corresponding body part of the subject, the adjustment means comprising modeling elements (39, 49, 59) of the active part, capable of applying the active part against the corresponding body part of the subject. subject to filling the or each refillable bladder (31, 41, 51) of the active part. 10. Pressure application garment according to any one of the preceding claims, wherein each active part (3, 4, 5) comprises means (37, 38, 39, 47, 48, 49, 57, 58, 59) adjustment means for adjusting the active part around the corresponding body part of the subject, the adjustment means comprising elements (37('), 38('), 47('), 48('), 57('), 58(')) for closing the active part (3, 4, 5), allowing the adjustment of the circumference of the active part around of the subject's corresponding body part. 11. Pressure application garment according to any one of the preceding claims, wherein at least one of the lower active parts (4) comprises an internal tensioning element (40) which, when the active part (4) is in its place around the subject's lower extremity (L ¹ ), it is capable of surrounding the subject's thigh and applying a tensing force to it. 12. Pressure application garment according to any one of the preceding claims, comprising a protective fabric (8), capable of being replaced with each use of the pressure application garment, which is removably fixed to the wall (33, 43, 53) of one or each active part (3, 4, 5) intended to be oriented to the part of the subject's body.