Pressure garment

文档序号:883351 发布日期:2021-03-19 浏览:8次 中文

阅读说明:本技术 施压服 (Pressure garment ) 是由 卡琳·博赛特 于 2019-05-29 设计创作,主要内容包括:一种施压服(1)包括三个活动部件(3、4、5),所述三个活动部件是旨在围绕受试者的腹部的一个腹部活动部件(3)和均旨在围绕受试者的下肢之一的两个下部活动部件(4、5),活动部件(3、4、5)中的每个包括至少一个可填充有流体的囊(31、41、51),以便获得通过所述活动部件施加的到受试者的腹部和下肢之间的所有相应身体部位的均匀正压力。施压服(1)包括:-对于每个活动部件(3、4、5),至少一个界面压力传感器(2),其被配置为在定位于所述活动部件与受试者的相应身体部位之间时测量在所述活动部件与受试者的相应身体部位之间的界面处的压力;-控制单元,其包括接收模块,其被配置为从每个活动部件(3、4、5)的一个或更多个界面压力传感器(2)接收界面压力测量结果;以及驱动模块,其被配置为基于接收模块针对每个活动部件所接收的界面压力测量结果来控制用于将流体注入到所述活动部件的一个或更多个可填充的囊(31、41、51)中的至少一个注入装置,以便保持所述活动部件的预定界面压力值。(An compression garment (1) comprising three active components (3, 4, 5), being one abdominal active component (3) intended to surround the abdomen of a subject and two lower active components (4, 5) each intended to surround one of the lower limbs of the subject, each of the active components (3, 4, 5) comprising at least one fluid-fillable bladder (31, 41, 51) in order to obtain a uniform positive pressure applied by said active components to all the respective body parts between the abdomen and the lower limbs of the subject. The compression garment (1) comprises: -for each active component (3, 4, 5), at least one interface pressure sensor (2) configured to measure a pressure at an interface between the active component and a respective body part of a subject when positioned between the active component and the respective body part of the subject; -a control unit comprising a receiving module configured to receive interface pressure measurements from one or more interface pressure sensors (2) of each movable part (3, 4, 5); and a drive module configured to control at least one injection means for injecting a fluid into one or more fillable bladders (31, 41, 51) of the mobile component based on the interface pressure measurements received by the receiving module for each mobile component so as to maintain a predetermined interface pressure value of the mobile component.)

1. Pressure garment (1) for applying pressure to a subject's body, comprising three movable parts (3, 4, 5), said three movable parts being one abdominal movable part (3) intended to surround a subject's abdomen (A) and one of the lower limbs (L) each intended to surround a subject1、L2) Each of said movable parts (3, 4, 5) comprising at least one fluid-fillable bladder (31, 41, 51) so as to obtain an application to the abdomen (A) and lower limbs (L) of the subject through said movable part(s)1、L2) In the direction of the pressure, said pressure garment (1) comprising:

-for each active component (3, 4, 5), at least one interface pressure sensor (2) configured to measure a pressure at an interface between the active component (3, 4, 5) and a respective body part of a subject when positioned between the active component (3, 4, 5) and the respective body part of the subject,

-a control unit (7) comprising: a receiving module (70) configured to receive interfacial pressure measurements from one or more interfacial pressure sensors (2) of each movable part (3, 4, 5); and a driving module (71) configured to drive at least one injection means (63, 64, 65) for injecting a fluid into one or more fillable bladders (31, 41, 51) of each mobile component, based on the interface pressure measurements received by the receiving module for said mobile component, so as to maintain a predetermined interface pressure value of each mobile component, the predetermined interface pressure value of the abdominal mobile component (3) being strictly lower than the predetermined interface pressure value of each lower mobile component (4, 5).

2. The pressure garment according to claim 1, wherein the control unit (7) is configured to maintain:

-a first predetermined interface pressure value of 10 to 20mmHg for said abdominal mobility component (3); and

-for each of said two lower movable parts (4, 5), a second predetermined interface pressure value is comprised between 20 and 40 mmHg.

3. The compression garment of claim 1 or claim 2, wherein the control unit (7) is configured to receive measurements representative of the subject's blood pressure and to control the or each injection means (64, 65) for injecting fluid into one or more fillable bladders of the lower active component (4, 5) so as to maintain the subject's blood pressure value (SBP, DBP) below a predetermined threshold.

4. The compression garment of any one of the preceding claims, wherein the control unit (7) is configured to receive measurements representative of the intracerebral blood flow of the subject, in particular measurements obtained by transcranial doppler, and to correlate changes in the measurements representative of the intracerebral blood flow with the body part (A, L) applied to the subject by means of the compression garment (1)1、L2) Are correlated.

5. Garment according to any one of the preceding claims, wherein, for each fillable bladder (31, 41, 51), the volume (V) for containing the fluid is delimited by a flexible layer (32-34, 42-44, 52-54) impermeable to the fluid, in particular having a substrate of textile and/or plastic material.

6. Garment according to any of the preceding claims, wherein each interface pressure sensor (2) is firmly fixed to a wall (33, 43, 53) of the movable part (3, 4, 5), said wall being intended to be directed towards a body part of the subject.

7. The compression garment of any one of the preceding claims, comprising, for each fillable bladder (31, 41, 51): at least one fill pressure sensor (60) for sensing a pressure of the fluid-filled bladder; and automatic servo control means between one or more filling pressure sensors (60) and one or more interface pressure sensors (2) of each movable part (3, 4, 5).

8. Garment according to any one of the preceding claims, wherein each interface pressure sensor (2) is a pneumatic sensor connected in a sealed manner to a measuring module (72), in particular by means of a flexible tube.

9. The compression garment of any one of the preceding claims, wherein each movable part (3, 4, 5) comprises adjustment means (37, 38, 39, 47, 48, 49, 57, 58, 59) for adjusting the movable part around the respective body part of the subject, the adjustment means comprising a pattern element (39, 49, 59) of the movable part which is capable of pressing the movable part against the respective body part of the subject when the or each fillable pocket (31, 41, 51) of the movable part is filled.

10. Pressure garment according to any of the preceding claims, wherein each movable part (3, 4, 5) comprises adjustment means (37, 38, 39, 47, 48, 49, 57, 58, 59) for adjusting the movable part around the respective body part of the subject, said adjustment means comprising a closing element (37 (), 38 (), 47 (), 48 (), 57 (), 58 ()) of the movable part (3, 4, 5) allowing to adjust the circumference of the movable part around the respective body part of the subject.

11. The pressure garment according to any one of the preceding claims, wherein at least one of the lower movable parts (4) comprises an internal tightening element (40) when the movable part (4) is around the lower limb (L) of the subject1) In position, the internal cinching member (40) is capable of surrounding and applying cinching force to a thigh of a subject.

12. Garment according to any one of the preceding claims, comprising a protective fabric (8), the protective fabric (8) being replaceable each time the garment is used, the protective fabric being removably fixed to a wall (33, 43, 53) of the or each movable part (3, 4, 5), the wall being intended to face a body part of the subject.

13. A method for placing an applicator according to any preceding claim on a subject, the method comprising the steps of:

-facing each active element (3, 4, 5) of the pressure garment in the deployed configuration towards a respective body part (A, L) of the subject1、L2) Positioning;

-placing each active component (3, 4, 5) of the pressure garment in the deployed configuration into an adjusted configuration in which it surrounds a respective body part (A, L) of the subject1、L2) Adjusting the movable part;

-filling each fillable bladder (31, 41, 51) of the pressure suit with a fluid until obtaining, for each movable part (3, 4, 5), a measurement from each interface pressure sensor (2) of the movable part substantially equal to a predetermined interface pressure value of said movable part.

14. A method for applying pressure to a subject's body according to a predetermined protocol, comprising: applying a first predetermined pressure value to the subject's abdomen (A) and a second predetermined pressure value to each lower limb (L) of the subject for a predetermined duration using a pressure garment (1)1、L2) Said compression garment comprising three active parts (3, 4, 5), said three active parts being one abdominal active part (3) intended to surround the abdomen (A) of the subject and the lower limbs (L) each intended to surround the subject1、L2) Two lower active parts (4, 5) of one, each of said active parts (3, 4, 5) comprising at least one fluid-fillable bladder (31, 41, 51) in order to obtain a uniform positive pressure applied by said active part to all respective body parts between the abdomen and the lower limbs of the subject; for each movable part (3, 4, 5), the compression garment (1) comprises at least one interface pressure sensor (2) configured to measure the pressure at the interface between the movable part and the respective body part of the subject when positioned between the movable part and the respective body part of the subject, the method comprising the steps of:

-facing each active element (3, 4, 5) of the pressure garment in the deployed configuration towards a respective body part (A, L) of the subject1、L2) Positioning;

-placing each active component (3, 4, 5) of the pressure garment in the deployed configuration into an adjusted configuration in which it surrounds a respective body part (A, L) of the subject1、L2) Adjusting the movable part;

-filling each fillable bladder (31, 41, 51) of the application garment with a fluid until obtaining, for each active component (3, 4, 5), a measurement from each interface pressure sensor (2) of the active component substantially equal to a predetermined pressure value to be applied to the body part of the subject corresponding to said active component;

-using, for each movable part (3, 4, 5), the interface pressure measurements received for each movable part as a basis for driving at least one injection means (63, 64, 65) of one or more fillable bladders (31, 41, 51) for injecting fluid into the movable part, during a predetermined duration, so as to maintain a measurement from each interface pressure sensor (2) of the movable part that is substantially equal to a predetermined pressure value to be applied to the body part of the subject corresponding to said movable part.

15. Method for applying pressure according to claim 14, wherein the or each fluid injection device (63, 64, 65) is automatically controlled using a control unit (7).

16. The method for applying pressure according to claim 14 or 15, wherein the predetermined protocol is LBPP treatment, wherein:

-a first predetermined pressure value to be applied to the abdomen (A) of the subject of between 10 and 20mmHg, preferably equal to about 10mmHg,

-to be applied to each lower extremity (L) of the subject1、L2) Is between 20 and 40mmHg, preferably approximately equal to 20mmHg,

-the first predetermined pressure value of the abdominal mobility component is strictly lower than the second predetermined pressure value of each lower mobility component,

the predetermined duration is approximately equal to 90 minutes.

17. The method for applying pressure according to any one of claims 14 to 16, comprising, before the step of filling each fillable bladder (31, 41, 51) of the pressure suit with a fluid to apply a predetermined pressure value to a body part of a subject: the step of measuring mobilized blood volume comprising applying a venous occlusion to one of the lower limbs of a subject and measuring by plethysmography the change in volume of said lower limb resulting from said occlusion and release thereof.

18. Method for applying pressure according to claim 17, wherein the venous occlusion is applied to the lower extremity of the subject by means of an internal tightening element (40) of one of the lower movable parts (4, 5) of the pressure garment (1), when the lower movable part (4, 5) surrounds the respective lower extremity (L) of the subject1、L2) In position, the internal cinching element (40) is configured to surround a thigh of the subject and to apply a cinching force to the thigh.

19. The method for applying pressure according to claim 17 or claim 18, wherein the lower extremity (L) caused by the occlusion and the release thereof is measured by aeroplethysmography by measuring the change of air pressure in the lower movable part (4, 5) of the compression garment (1) forming an inflatable cuff around the lower extremity of the subject1、L2) The volume of (c) is changed.

20. Method for applying pressure according to any one of claims 17 to 19, wherein, when the measured regulable blood volume is smaller than a predetermined threshold value, the predetermined pressure value is applied to a body part (A, L) of a subject by means of a compression garment (1)1、L2) Previously, saline was injected into the venous network of the subject.

Technical Field

The present invention relates to a compression garment for applying pressure to the body of a subject, the garment being intended to apply pressure to the abdomen of the subject and to the lower limbs of the subject. In particular, the present invention relates to a compression garment for applying pressure to the body of a subject according to the principle of "positive lower body pressure" (LBPP), so as to be able to re-establish the blood vessels of the brain by mobilizing the blood contained in the lower body of the subject. The invention also relates to a method for placing such a pressure suit on a subject, and to a method for applying pressure to the body of a subject.

Background

The "positive lower pressure" (LBPP) principle involves applying a constant low pressure level, in particular 10 to 40mmHg, to the abdomen of the subject and to the lower limbs of the subject, wherein the pressure applied to the abdomen is strictly less than the pressure applied to the lower limbs. This concept was originally developed to ensure adequate volume distribution in the sub-aortic and upper regions, particularly for microgravity flight. LBPP has been shown to transfer blood from the lower body to the upper body, thereby increasing central cardiopulmonary blood volume.

WO2008104861a1 discloses the use of LBPP for treating individuals suffering from vascular deficiencies affecting the upper part of the body, in particular cerebrovascular deficiencies or ocular diseases. This document describes the use of antigravity pants or medical anti-shock pants (MAST) to apply LBPP, such as those sold by LIFE SUPPORT PRODUCTS INC of St.Louis, Mo. This medical anti-shock pants comprises three independent air chambers that allow positive pressure to be applied to the abdomen and two lower limbs of the subject, respectively. The air chambers are each connected to a pneumatic tip and are manually inflated using a pump, with an instantaneous pressure value being provided by a pressure gauge at each air chamber.

A pair of medical anti-shock pants has a stiff structure, which complicates the placement of the pants for bedridden subjects or subjects suffering from quadriplegia, such as subjects who have suffered from a stroke or a cerebrovascular accident (CVA). Moreover, medical anti-shock pants are typically provided in only one size, which is not suitable for all configurations. However, if the subject's morphology is not compatible with the size of medical anti-shock pants, there is a risk that the pressure value indicated by the manometer does not correspond to the pressure effectively applied to the subject's body part. This makes the application of pressure to the subject's body unreliable. In addition, implementing LBPP with medical anti-shock pants also requires manual adjustment and monitoring of pressure over time to ensure that the pressure applied to the subject remains constant at every part of the body, which is time consuming.

More specifically, the present invention aims to overcome these drawbacks by proposing an applicator garment that allows to apply a uniform and constant pressure level to a body part of a subject in an automatic, reliable and precise manner.

Disclosure of Invention

To this end, the invention relates to a compression garment for applying pressure to the body of a subject, the garment comprising three movable parts, one abdominal movable part intended to surround the abdomen of the subject and two lower movable parts each intended to surround one of the lower limbs of the subject, each of the movable parts comprising at least one fluid-fillable bladder, in order to obtain a uniform positive pressure applied by the movable parts to all respective body parts between the abdomen and the lower limbs of the subject, wherein the garment comprises:

for each movable part, at least one interface pressure sensor configured to measure a surface pressure at an interface between the movable part and a respective body part of the subject when positioned between the movable part and the respective body part of the subject,

-a control unit comprising: a receiving module configured to receive interfacial pressure measurements from one or more interfacial pressure sensors of each movable component; and a driving module configured to drive at least one injection device for injecting a fluid into one or more fillable bladders of the mobile component so as to maintain a predetermined interface pressure value of each mobile component, based on the interface pressure measurements received by the receiving module for each mobile component, the predetermined interface pressure value of the abdominal mobile component being strictly lower than the predetermined interface pressure value of each lower mobile component.

The contribution of the invention is that the interface pressure considered by the control unit for each movable part represents the pressure actually applied by the movable part to the respective body part of the subject, measured by means of at least one interface pressure sensor positioned between the movable part and the respective body part of the subject, which allows for an automatic, reliable and accurate application of the pressure by means of the compression garment according to the invention. In contrast, if the pressure considered by the control unit for each movable part is only the filling pressure of each bladder of the movable part, in particular the pressure measured using a manometer installed in the connecting tube between the bladder and the injection means for injecting the fluid into the bladder, the control of the applied pressure is not reliable, since the filling pressure of the bladder cannot systematically represent the pressure actually applied by the bladder to the respective body part of the subject, which depends on the degree of adjustment of the garment surrounding the subject's body.

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

-for an abdominal mobility element, a first predetermined interface pressure value comprised between 10 and 20mmHg, preferably equal to about 10mmHg,

-for each of the two lower active parts, the second predetermined interface pressure value is comprised between 20 and 40mmHg, preferably equal to about 20mmHg,

the first predetermined interface pressure value of the abdominal mobility component is strictly less than the second predetermined interface pressure value of each lower mobility component.

The compression suit according to the invention is therefore configured to automatically apply pressure to the body of the subject according to the principle of "positive lower body pressure" (LBPP), so as to generate a pressure gradient between the abdomen on the one hand and the lower limbs on the other hand, so as to revascularize the brain by mobilizing the blood contained in the lower body of the subject. More specifically, the compression garment according to the invention allows revascularization of the brain in a passive manner by increasing the circulating plasma volume. The control unit allows for automatic control of the interface pressure based on the interface pressure measurements and the interface pressure set points, and servo control of the injection of fluid into the one or more bladders of each movable component, thereby ensuring that a constant pressure is applied for the duration of the treatment session without manual intervention.

It should be noted that the therapeutic passband for applying the LBPP regimen on the lower extremities must be 20 to 40mmHg and must not exceed 40 mmHg. More specifically, it has been found that above 40mmHg, the increase in cardiac preload (or the filling pressure of the heart) is so great as to stimulate the sympathetic nervous system, which has a reflex effect on the vascular tone of the main aorta, which leads to vasodilation and a reduction in arterial blood pressure. For subjects suffering from stroke, the autoregulation of the brain has ceased due to the stroke, which leads in particular to reduced brain perfusion. It is therefore detrimental to apply pressure values in excess of 40mmHg to the lower limb. Under these conditions, the pressing garment according to the invention is configured to maintain a second predetermined interface pressure value less than or equal to 40mmHg for each of the two lower movable parts.

According to one feature, the control unit is configured to receive measurements representative of the blood pressure of the subject, in particular acquisitions made continuously during a treatment session, and to control the or each infusion device for infusing a fluid into one or more of the inflatable bladders of the lower active component so as to maintain the blood pressure value of the subject below a predetermined threshold, in particular so as to bring 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 measurements obtained by transcranial doppler, and to correlate changes in the measurements representative of the intracerebral blood flow with pressure gradients applied to a body part of the subject by means of the compression garment. Such a configuration advantageously allows the practitioner to select a therapeutic target, for example, to target an average 30% increase in cerebral blood flow as compared to the beginning of the therapeutic session. Thus, an alarm can be generated when the therapeutic goal has been reached, whereby the practitioner decides whether to continue the course of treatment or not, depending on the functional result obtained.

The provision of interface pressure sensors for each of the three movable components allows the amount of pressure effectively applied to the abdomen and lower extremities of the subject to be controlled, with each interface pressure sensor being positioned directly between the movable component and a respective body part of the subject. In particular, in the case of LBPP, the pressure value applied to the abdomen is advantageously comprised between 10 and 20mmHg, preferably approximately equal to 10mmHg, and the pressure value applied to each lower limb is advantageously comprised between 20 and 40mmHg, preferably approximately equal to 20 mmHg. The control using the interface pressure sensor also ensures that the pressure applied to each body part of the subject remains constant for the duration of the entire pressure application session, especially for about 90 minutes in the case of LBPP.

Preferably, each movable part of the compression garment comprises a single fillable bladder to simplify the design of the garment. The number and arrangement of interface pressure sensors is adapted to provide pressure measurements representative of pressure effectively applied to a body part of the subject for each movable part, while in particular avoiding positioning the sensors on bone parts.

By way of example, in one particular embodiment:

the abdominal activity part of the pressure garment comprises three interface pressure sensors, including one front central sensor intended to be positioned in front of the center of the abdomen, and two lateral sensors intended to be positioned on the sides of the abdomen.

Each lower active part of the pressure garment comprises three to five interface pressure sensors, including one or two rear sensors intended to be positioned on the lower leg, in particular a rear lower sensor located on the rear surface of the lower leg, and possibly also a medial lower sensor on the medial side of the lower leg, two or three upper sensors intended to be positioned on the thigh, in particular a rear upper sensor on the rear surface of the thigh, a medial upper sensor on the medial side of the medial thigh, and possibly also a medial anterior upper sensor on the anterior medial side of the thigh.

The dimensions of each interfacial pressure sensor, and more particularly the measurement surface area, can be different from sensor to sensor, particularly depending on their location. Thus, for example, for an abdominal activity component, the measurement surface area of the front central sensor can be selected to be larger than the measurement surface area of the lateral sensors.

According to an aspect of the invention, for each fillable bladder, the volume for containing the fluid is delimited by a flexible layer impermeable to said fluid, in particular having a substrate of textile and/or plastic material. Preferably, the material of the impermeable layer has elastic properties, which can be obtained, for example, by incorporating elastic fibres into the material of the layer or, in the case of a layer comprising a woven fabric, by weaving the fabric. Advantageously, the material of the impermeable layer is chosen so as to enable washing on its outer surface, i.e. the outward surface of the capsule.

In one embodiment, the fluid filling each bladder is air, whereby the flexible layer defining the volume of each bladder is airtight within a given pressure range, compatible with the air pressure to be applied in the bladder, to apply the required positive pressure to the body of the subject. Such a gastight layer can in particular be a layer of plastic material that is self-supporting or deposited on the substrate. In particular, the airtight layer can comprise the superposition of a woven or non-woven fabric layer, in particular with a substrate of nylon, polypropylene, polyester, polyamide or cotton, and a coating, in particular with a substrate of polyurethane, silicone, polyvinyl chloride (PVC) or other plastic material. Preferably, the fabric layer has a weight per unit area of 150 to 250g/m2. One example of a material that can be used to form an air barrier within the scope of the present invention includes a knitted nylon layer coated on one side with a polyurethane coating. Due to the air tightness of the flexible layer forming each capsuleNo air chamber is required because the bladder itself acts as an air chamber. This results in a flexible structure of each inflatable bladder which improves the wearing comfort of the compression garment and facilitates its placement on a subject, including bedridden or paralyzed subjects.

Advantageously, each movable part is a flexible part that is transitionable between a deployed configuration that allows it to be placed around a respective body part of the subject and an adjusted configuration in which it is adjusted around the respective body part of the subject. In the adjustment configuration, the movable member has a tubular shape and the inwardly facing wall is capable of applying a positive pressure to a body part of the subject.

According to one embodiment, each movable part is a part having a base of fabric and/or plastic material comprising a first portion and a second portion superposed on each other and impermeable to said fluid, the first portion and the second portion defining between them a volume for containing the fluid of each fillable bladder. In the adjusted configuration of the movable member on the respective body part of the subject, the first portion is directed inwardly and the second portion is directed outwardly. The first and second portions are advantageously connected to each other by a peripheral seam impermeable to said fluid or by any other peripheral connecting means impermeable to said fluid.

According to an advantageous feature, each interface pressure sensor is firmly fixed to the inner wall of the mobile part, i.e. the wall intended to be directed towards the corresponding body part of the subject. In particular, the interface pressure sensor can be housed in a barrier layer provided for this purpose on the inner wall of the movable part. Alternatively, the interface pressure sensor can be fixedly secured to the inner wall of the movable part by any other suitable means, in particular by stitching or adhesive bonding or the like.

Advantageously, each fillable bladder of the compression garment comprises at least one filling end piece designed to be connected to a fluid injection means. For each fillable bladder, the compression garment is further provided with at least one fill pressure sensor, such as a pressure gauge, for sensing the pressure of the fluid-filled bladder. In particular, for each fillable bladder, the filling pressure sensor can be mounted in a connecting tube between a filling end piece of the bladder and the respective fluid injection means. Advantageously, the compression garment comprises automatic servo control means between one or more filling pressure sensors and one or more interface pressure sensors of each movable part. In particular, one or more filling pressure sensors of each movable part can be connected to the control unit, so that an automatic servo-control system can be established between the filling pressure sensor and the interface pressure sensor of each movable part in order to obtain a constant, controlled pressure applied to each body part of the subject for the duration of the entire pressure application session. In the case of LBPP, this principle involves mobilization of the blood of the lower body, which must be kept constant, controlled and automatically regulated to compensate for the loss, while not being too high to prevent harmful effects. This constant and controlled mobilization of the blood requires the application of a constant, controlled and automatically regulated pressure to each body part of the subject for the duration of the treatment session.

Within the scope of the present invention, the injection means for injecting the fluid into the one or more fillable bladders of each movable part of the compression garment can be a pump or a compressed air supply system, for example available in hospitals. In an advantageous embodiment, the injection means for injecting the fluid into the one or more fillable bladders of each movable part of the compression garment is a portable device that allows the compression garment to be used during transport of the subject. In one embodiment, the injection means for injecting fluid into the one or more fillable bladders of each movable part of the compression garment is a portable pump incorporated into the garment.

According to an advantageous embodiment, each interface pressure sensor is a pneumatic sensor, which is connected to the measurement module in a sealed manner, in particular by means of a flexible tube. The use of such pneumatic sensors has the advantage of limiting the electronics that must be embedded directly in the moving parts of the compression garment. In particular, the pneumatic sensor can be a sensor as disclosed in patent document WO2009072011a1, which comprises a cushion with a flexible polymeric sheath, for example made of silicone, which is able to contain in its internal volume a predetermined volume of injected air corresponding to a known positive pressure. The measurement module includes a pressure gauge and an air injection piston in fluid communication with each other and with the pneumatic sensor. The measurement module of each sensor is configured to transmit the interfacial pressure measurement to the receiving module of the control unit. Such transmission of data can be by any means, in particular by wired connection means or by wireless means such as bluetooth or WiFi. Advantageously, the measuring module of each pressure sensor is integrated into the housing of the control unit.

Alternatively, each interface pressure sensor can be an electronic sensor, in particular a sensor that measures the force exerted on a surface at the interface between the active site and the respective body part of the subject, by which sensor the interface pressure is calculated. Each electronic sensor is configured to transmit the interface pressure value to a receiving module of the control unit. Such transmission of data is preferably performed by wireless connection means such as bluetooth or WiFi.

According to one aspect of the invention, each movable part comprises adjustment means for adjusting the movable part around the respective body part of the subject in order to assume the shape of the respective body part of the subject as much as possible and to obtain the most efficient and uniform pressure application possible to the respective body part of the subject.

According to one feature, for each movable part, the adjustment means comprise a pattern element of the movable part which is capable of pressing the movable part against the respective body part of the subject when the or each fillable bladder of the movable part is filled.

The pattern elements of each movable component allow patterning of the movable component in the filled state so as to press it against and apply a controlled and predictable surface pressure to a corresponding body part of a subject. This therefore prevents any "floating" effect in which the movable parts inflate without applying a controlled and uniform pressure to the body part of the subject when filling each movable part.

In the particular example of LBPP, the particular pattern of the pressure garment according to the invention allows to apply in a reliable and controlled manner the desired pressure values, i.e. the pressure applied to the abdomen is advantageously of a value comprised between 10 and 20mmHg, preferably approximately equal to 10mmHg, and the pressure value applied to each lower limb is advantageously comprised between 20 and 40mmHg, preferably approximately equal to 20 mmHg.

In case each movable part of the compression garment comprises a single fillable pocket, the presence of the pattern elements of each movable part is even more important in order to assume the shape of the corresponding body part of the subject and to obtain a uniform pressure application when filling the fillable pockets of the movable parts, especially for lower movable parts having a larger filling volume.

According to one feature, for each movable part of the compression garment, the pattern element comprises at least one sculpted line, in particular a seam, of the layer delimiting the fluid containing volume of each fillable bladder of the movable part, which sculpted line is required to shape the movable part in the filled state to assume the shape of the corresponding body part of the subject. In general, the pattern element includes a raised pattern structure of the active component that is capable of applying or pressing the active component against the respective body part of the subject when filling the or each fillable bladder of the active component. The raised pattern can be a sculpted seam or a thermal fuse of a fabric-based and/or plastic-based flexible layer forming one or more bladders of the movable component.

The adjustment means are designed for adjusting each of the movable parts of the compression garment around the respective body part of the subject in order to assume the shape of the respective body part of the subject as much as possible and to obtain the most efficient and uniform pressure application possible. In the adjustment configuration, the movable member has a generally tubular shape.

According to one feature, the adjustment means comprise a closing element of the mobile part, allowing the perimeter of the mobile part around the respective body part of the subject to be adjusted, preferably in an adaptive manner over the entire length of the tubular mobile part. According to a particular embodiment, the closing element comprises at least one pair of entrainment bands comprising a first band provided with hooks and a second band provided with loops, the first and second bands extending over the length of the mobile element. Alternatively or in combination therewith, the closure element can comprise a plurality of lacing tapes distributed over the length of the movable part and a clip system.

According to one feature, the lower active component of the compression garment is connected to the abdominal active component to facilitate placement of the garment on the subject's body. According to one feature of the invention, each lower active component comprises, at its end opposite the abdominal active component, a plurality of segments which can be folded back on each other to adapt the length of the lower active component to the length of the corresponding lower limb of the subject. Similarly, the abdominal mobility component comprises a plurality of segments at one end that are capable of being folded back upon each other to adapt the length of the abdominal mobility component to the length of the subject's abdomen. Preferably, for each movable part, in the state in which the segments are folded back on each other, the portion of the fillable bladder corresponding to the folded segment is not filled with fluid. To further improve the adaptability of the compression garment to the morphology of each subject, the segments present that can be folded or rolled can be combined with different garment sizes (e.g. S, M, L, XL) provided.

According to one aspect of the invention, at least one of the lower movable parts of the compression garment comprises an internal tightening element which is able to surround the thigh of the subject and to apply a tightening force thereto, when the lower movable part is in place around the lower limb of the subject. The internal cinching member can thus act as a tourniquet, resulting in vein occlusion on the thigh of the subject. Preferably, the internal lacing element is a cuff intended to be inflated to a standard pressure (50 mmHg). It is advantageous to combine the use of an internal constricting element to apply a venous occlusion at the thigh of a subject with the measurement of the change in volume of the lower limb caused by the venous occlusion and its release to assess mobilized blood volume (or "venous bed").

In case the estimate of the mobilizable blood volume is zero or less than a predetermined value, a fluid, in particular 500mL of physiological saline, can be injected into the venous network before the pressure application session using the compression garment according to the invention.

The volume change of the lower limb, in particular air plethysmography, can be measured using different plethysmography techniques, for example by measuring the air pressure change in the lower movable part of an inflatable cuff forming the lower limb surrounding the subject of an compression garment. More specifically, the implementation principle is as follows: the constricting element surrounding an interior of a thigh of the subject is inflated to cause vein occlusion at the thigh of the subject; thus, the lower limb of the subject swells due to obstruction of venous return; the femoral tourniquet is then released and the subject's lower limb resumes its original volume as venous return resumes normal flow. Lower limb volume changes provide an estimate of the mobilized fluid volume including lymph and venous blood. Advantageously, the compression garment according to the invention not only allows venous occlusion to be obtained by means of the internal constricting element of the lower movable part, but also allows the difference between the volume of the lower limb at rest and the volume of the lower limb a few minutes after the application of the venous occlusion to be measured by air plethysmography by directly using the lower movable part of the compression garment forming a cuff around the lower limb of the subject and by measuring the amount of air in this cuff before and after the application of the venous occlusion.

According to an advantageous feature, the compression garment comprises a protective fabric which can be replaced each time the garment is used, which is removably fixed to the inner wall of the or each active part of the garment, i.e. the wall on which the active part faces the inside in a configuration in which the active part is adjusted around the respective body part of the subject. The protective fabric acts as a "second skin" to prevent irritation of the subject's skin due to contact with the movable member. The protective fabric also prevents soiling of the moving parts. Preferably, the protective fabric is disposed on the inner wall of each movable member when tensioned, and is held in tension by any suitable means, such as a strap or other means. More specifically, it is important to avoid protection within the scope of the pressure application session, in particular within the scope of LBPPFolds in the fabric. An example of a fabric suitable for use as a protective fabric is a fabric having a weight per unit area of 40 to 170g/m2The microfiber fabric of (1).

The invention also relates to a method for placing an applicator as described above on a subject, said method comprising the steps of:

-positioning each movable part of the compression garment in the deployed configuration facing a respective body part of the subject.

-placing each movable part of the pressure garment in the deployed configuration into an adjustment configuration in which the movable part is adjusted around the respective body part of the subject.

-filling each fillable bladder of the pressure garment with a fluid until obtaining, for each movable part, a measurement from each interface pressure sensor of the movable part substantially equal to a predetermined interface pressure value of said movable part.

In the case of a subject who can only place the compression garment while the subject is in a lying position, the method of placing the compression garment as described above comprises the steps of:

-placing the compression garment on the bed with each of the movable parts in the deployed configuration;

-placing each body part of the subject on a respective movable part of the garment while placing the back of the subject on the compression garment;

-each movable part of the compression garment in the deployed configuration is placed in an adjustment configuration in which the movable part is adjusted around a respective body part of the subject;

-filling each fillable bladder of the pressure garment with a fluid until obtaining, for each movable part, a measurement from each interface pressure sensor of the movable part substantially equal to a predetermined interface pressure value of said movable part.

The invention also relates to a method of applying pressure to a body of a subject according to a predetermined protocol, the method comprising: applying a first predetermined pressure value to the subject's abdomen and a second predetermined pressure value to each of the subject's lower limbs for a predetermined duration using a compression garment comprising three active components, one abdominal active component intended to surround the subject's abdomen and two lower active components each intended to surround each of the subject's lower limbs, each of the active components comprising at least one fluid-fillable bladder, so as to obtain a uniform positive pressure applied by the active components to all respective body parts between the subject's abdomen and lower limbs; for each movable component, the compression garment includes at least one interface pressure sensor configured to measure pressure at an interface between the movable component and a respective body part of the subject when positioned between the movable component and the respective body part of the subject, the method including the steps of:

-positioning each movable part of the compression garment in the deployed configuration facing a respective body part of the subject;

-placing each movable part of the compression garment in the deployed configuration into an adjustment configuration in which the movable part is adjusted around a respective body part of the subject;

-filling each fillable bladder of the compression garment with a fluid until obtaining, for each movable part, a measurement from each interface pressure sensor of the movable part substantially equal to a predetermined pressure value to be applied to the body part of the subject corresponding to said movable part;

-for each movable part, using the interface pressure measurements received for each movable part as a basis for actuating at least one injection means for injecting fluid into one or more fillable bladders of the movable part, thereby injecting fluid into the one or more fillable bladders of the movable part, maintaining a measurement from each interface pressure sensor of the movable part substantially equal to a predetermined pressure value to be applied to the body part of the subject corresponding to said movable part, during a predetermined duration.

According to one embodiment of the method for applying pressure, the or each fluid injection device is automatically driven using a control unit.

According to one embodiment of the method for applying pressure, the predetermined protocol is an LBPP treatment, wherein:

a first predetermined pressure value to be applied to the abdomen of the subject of between 10 and 20mmHg, preferably equal to about 10mmHg,

-a second predetermined pressure value to be applied to each lower extremity of the subject is comprised between 20 and 40mmHg, preferably approximately equal to 20mmHg,

-the first predetermined pressure value of the abdominal mobility component is strictly lower than the second predetermined pressure value of each lower mobility component,

the predetermined duration is approximately equal to 90 minutes.

According to one embodiment, a method for applying pressure, prior to the step of filling each fillable bladder of a pressure suit with a fluid to apply a predetermined pressure value to a body part of a subject, comprises: the step of measuring mobilized blood volume comprising applying a venous occlusion to one of the lower limbs of a subject and measuring by plethysmography the change in volume of said lower limb resulting from said occlusion and release thereof.

According to one feature, the venous occlusion is applied to the lower limb of the subject by means of an internal tightening element of one of the lower movable parts of the compression garment, said internal tightening element being able to surround the thigh of the subject and to apply a tightening force thereto when the lower movable part is in position around the respective lower limb of the subject.

According to one feature, the volume change of the lower limb caused by occlusion and release thereof is measured by air plethysmography by measuring the air pressure change in the lower moving part of the compression garment forming an inflatable cuff around the lower limb of the subject.

According to one feature, when the measured mobilized blood volume is less than the predetermined threshold, saline is injected into the venous network of the subject to increase the mobilized blood volume before the predetermined pressure value is applied to the body part of the subject by means of the compression garment.

Drawings

The features and advantages of the invention will become apparent from the following description of an embodiment of the pressure garment and method for applying pressure according to the invention, which is provided by way of example only and with reference to the accompanying drawings, in which:

figure 1 is a front view of a pressure garment according to a first embodiment of the invention;

figure 2 is a rear view of the compression garment of figure 1;

FIG. 3 is a front view of the pressure garment of FIG. 1 with the movable parts in a deployed configuration;

figure 4 is a section on an enlarged scale along the plane IV-IV of figure 3;

FIG. 5 is a front view of the compression garment of FIG. 1 placed on the subject and connected to the air injection means;

FIG. 6 is a view similar to FIG. 1 of a compression garment according to a second embodiment of the invention;

fig. 7 is a view similar to fig. 5 of a pressure suit according to a third embodiment of the invention, from which the air injection means have been omitted for better visibility; and

figure 8 is a rear view of the pressure garment of figure 7.

Detailed Description

As shown in fig. 1 to 5, the pressure suit 1 of the first embodiment includes three movable parts, namely: an abdominal activity component 3 intended to surround the abdomen a of the subject; and two lower mobile parts 4, 5, each of which is intended to surround one leg or lower extremity L of the subject1,L2. Each of the movable parts 3, 4, 5 of the pressure garment 1 is a flexible textile part made of an airtight material. In particular, in this example, the airtight material of each mobile element 3, 4, 5 comprises a knitted nylon fabric layer coated on one side with a polyurethane coating. For easy placement of the pressure garment 1 on the subject's body, the two lower active components 4, 5 are connected to the abdominal active component 3 by means of joining elements 9, the joining elements 9 being in particular elastic fabric strips. Each movable part 3, 4, 5 is capable of assuming a substantially flat unfolded configuration as shown in fig. 3 (allowing it to be placed around the respective body of the subjectBody part placement) and a tubular configuration as shown in fig. 1, 2, 5, wherein the components are adjustable around and about a respective body part of the subject.

As shown for the movable part 5 in the sectional view of fig. 4 (it is understood that the section of the movable parts 3 and 4 is similar to that of the movable part 5), each movable part 3, 4, 5 of the compression garment 1 comprises a superposition of an inner textile part 33, 43, 53 intended to face the body of the subject and an outer textile part 34, 44, 54 intended to face the outside, both made of airtight material as described above. For each movable element 3, 4, 5, the inner 33, 43, 53 and outer 34, 44, 54 textile elements made of airtight material are joined together by a peripheral seam 32, 42, 52, which is also airtight. Thus, for each movable part 3, 4, 5 of the compression garment 1, an airtight bladder 31, 41, 51 is defined between the inner textile element 33, 43, 53 and the outer textile element 34, 44, 54, the inner volume V of the bladder 31, 41, 51 being fillable with air.

In this example, each movable part 3, 4, 5 comprises a single inflatable bladder 31, 41, 51 which has the advantage of simplifying the design of the compression garment 1. Alternatively, however, each movable part 3, 4, 5 can comprise a plurality of fillable bladders. Each of the inflatable bladders 31, 41, 51 of the compression garment 1 is intended to be air-filled such that the inner textile element 33, 43, 53 exerts a positive pressure on the respective body part of the subject in the adjusted configuration of the active elements 3, 4, 5 on the respective body part of the subject.

Each fillable bladder 31, 41, 51 of the compression garment 1 comprises a plurality of filling end pieces 36, 46, 56 distributed over the bladder surface to optimize filling of the bladder. As shown in fig. 5, the filling end pieces 36, 46, 56 of the movable parts 3, 4, 5 are adapted to be connected to air injection means 63, 64, 65. Different types of air injection means can be used within the scope of the invention. In particular, each air injection device 63, 64, 65 can be a portable pump integrated into the garment 1, or can be a compressed air supply in a hospital. Each fillable bladder 31, 41, 51 is provided with at least one pressure gauge 60 for measuring the pressure of the air filled in the bladder. Preferably, in order to measure the filling pressure in the different zones of each fillable bladder 31, 41, 51, a pressure gauge 60 is installed in each connecting tube between the filling end piece 36, 46, 56 of the bladder and the respective air injection means 63, 64, 65.

For controlling the effective application of the abdominal mobility member 3 to the subject's abdomen A and of the lower extremities L of the subject by the lower mobility members 4, 51,L2The garment 1 comprises an interfacial pressure sensor 2 mounted on the inner textile element 33, 43, 53 of each movable element 3, 4, 5. Each sensor 2 is intended to measure the pressure at the interface between the movable part 3, 4, 5 to which it is attached and the respective body part of the subject. Each sensor 2 can, for example, be sewn into a spacer layer provided for this purpose in the respective inner textile part 33, 43, 53. Alternatively, each sensor 2 can be firmly fixed to the respective inner textile element 33, 43, 53 by any other suitable means, in particular by stitching or gluing, etc.

In an exemplary embodiment, each interface pressure sensor 2 can be a pneumatic sensor as disclosed in patent document WO2009072011a1, comprising a flexible polymer mat capable of containing in its internal volume a predetermined amount of injected air corresponding to a known positive pressure, the mat being connected in a sealed manner to the measurement module 72 by a flexible tube (not shown). The measuring module 72 of each sensor 2 comprises in particular a pressure gauge 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 avoids the need for electronic components on the movable parts 3, 4, 5 of the press garment 1, so that the electronic components are offset in the measuring module 72 outside the textile part. These pneumatic sensors also have the advantage of being compatible with the relatively low interface pressure levels sought by LBPP, which are in particular between 10 and 40 mmHg. It goes without saying that the compression suit 1 can alternatively comprise electronic interface pressure sensors, as long as the sensitivity of these electronic sensors is compatible with the sought level of interface pressure.

For each movable part 3, 4, 5, the number and arrangement of interface pressure sensors 2 is adapted to provide a pressure measurement representative of the pressure effectively applied to the body part of the subject. By way of non-limiting example, in this embodiment, the abdominal activity part 3 of the compression suit 1 comprises three interface pressure sensors 2, namely a front central sensor 2 intended to be positioned in front of the center of the subject's abdomen, and two lateral sensors 2 intended to be positioned at the sides of the abdomen. Each lower active part 4, 5 of the compression garment 1 comprises five interface pressure sensors 2, namely one rear lower sensor 2 intended to be positioned at the rear of the subject's calf, one medial lower sensor 2 intended to be positioned at the medial side of the calf, one rear upper sensor 2 intended to be positioned at the rear of the subject's thigh, one medial upper sensor 2 intended to be positioned at the medial side of the thigh, and one front medial upper sensor 2 intended to be positioned at the front medial side of the thigh.

The pressure applying suit 1 comprises a control unit 7 as shown in fig. 5, which can take the form of a housing that can be attached to the surface of the fabric part of the pressure applying suit 1 or to an element of the furniture, such as a bed or the like, on which the pressure applying session is performed using the suit 1. In the case of an interface pressure sensor 2 of the pneumatic type, the measurement module 72 associated with each pneumatic interface pressure sensor of the presser suit 1 is advantageously integrated into the casing of the control unit 7, which also comprises a receiving module 70 configured to receive the interface pressure measurements from the measurement module 72 of each pneumatic interface pressure sensor. Thus, the connection between each measurement module 72 and the receiving module 70 can be wired or wireless. In the case of interface pressure sensors 2 of the electronic type, each electronic interface pressure sensor is configured to transmit the interface pressure measurement directly to the receiving module 70 of the control unit 7, in particular by wireless connection means. One or more fill pressure gauges 60 of each fillable bladder 31, 41, 51 are also connected to the receiving module 70 of the control unit 7. Thus, an automatic servo system can be generated between the filling pressure sensor 60 and the interface pressure sensor 2 of each movable part 3, 4, 5.

As shown in fig. 5, the receiving module 70 of the control unit 7 is further configured to receive:

measurements obtained, in particular continuously obtained, using a tensiometer 67 comprising a cuff positioned on the arm of the subject representing the blood pressure of the subject during the course of the treatment; in particular, measurements indicative of the subject's blood pressure include Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), mean arterial blood pressure;

measurements representative of the blood flow in the brain of the subject during a treatment session obtained, in particular continuously, by using a transcranial doppler apparatus of the device 68 comprising a probe, typically a 2MHz doppler probe, associated with a calculation unit, positioned on the head of the subject; in particular, measurements indicative of blood flow in the brain of a subject include Peak Systolic Velocity (PSV), End Diastolic Velocity (EDV), electrical resistance index, area under the curve.

The control unit 7 further comprises a driving module 71 configured to drive one or more air injection devices 63, 64, 65 according to:

-receiving, by means of the receiving module 70, the interface pressure measurement for each movable part 3, 4, 5, in order to maintain a predetermined interface pressure set-point for said movable part;

receiving, by means of the receiving module 70, measurements representative of the subject's blood pressure in order to keep the subject's blood pressure value below a predetermined threshold, in particular to keep the Systolic Blood Pressure (SBP) strictly below 220 and the Diastolic Blood Pressure (DBP) strictly below 120:

receiving the measurement representative of the intracerebral blood flow of the subject by means of the receiving module 70, in order to correlate the variation of the measurement representative of the intracerebral blood flow of the subject with the pressure gradient applied to the body part of the subject by means of the compression garment, and/or to correlate the measurement representative of the intracerebral blood flow of the subject with a therapeutic target, for example an increase of 30% in the mean value of the intracerebral blood flow compared to the beginning of the course of treatment, and possibly to issue an alarm when said therapeutic target has been reached, whereby the practitioner decides whether or not to continue the treatment depending on the functional result obtained.

The control unit 7 provides automatic control of the interface pressure on the basis of the interface pressure measurements from the sensor 2 and the predetermined interface pressure set-points for each movable part, and provides servo control of the air injection in the bladder 31, 41, 51 of each movable part 3, 4, 5, so that a constant and controlled pressure can be applied to each body part of the subject in an automatic manner without manual intervention for the entire duration of the pressure application session using the compression garment 1.

In particular, according to one example, for the application of LBPP using the compression garment 1, the predetermined interface pressure set-point for the abdominal activity component 3 is 10mmHg and the predetermined interface pressure set-point for each lower activity component 4, 5 is 20mmHg, whereby the garment 1 is advantageously configured to maintain the predetermined interface pressure set-point for each activity component 3, 4, 5 for a duration of about 90 minutes.

In order to better adapt the shape of each body part of the subject and to obtain the most efficient and uniform pressure application possible to each part of the body, each movable part 3, 4, 5 of the pressure application suit 1 comprises adjustment means to adjust the movable part 3, 4, 5 around the respective body part of the subject. In the example shown in fig. 1-5, these adjustment means comprise a pair of straps on each of the movable members 3, 4, 5, allowing the movable members to surround the respective body part A, L of the subject in an adjusted configuration1、L2To close.

More specifically, in the example shown, each mobile part 3, 4, 5 comprises, over its entire length in the axial direction of the tubular configuration: a first strap 37, 47, 57 provided with hooks, located at a first longitudinal end of the mobile element, on the side of the outer fabric portion 34, 44, 54; and a second clip strap 38, 48, 58 provided with a loop at the second longitudinal end of the movable element and on the side of the inner fabric portion 33, 43, 53. The entrainment 37, 38, 47, 48, 57, 58 allows to surround the respective body part A, L of the subject in a suitable manner over the entire length1、L2To adjust the circumference of the movable parts 3, 4, 5.

Each of the two lower active parts 4, 5, opposite the abdominal active part 3, also comprises a part 45, 55 which can be rolled up with the aim of adapting the length of the lower active part 4, 5 to the lower limb L of the subject1、L2To the lower extremities L in a most targeted manner1、L2A positive pressure is applied. As shown in fig. 1 and 5, each rolling member 45, 55 is formed of a plurality of segments S configured to be folded back on each other. Preferably, in the state in which the segments S are folded back on each other, the portions of the fillable bladders 41, 51 corresponding to the folded segments S cannot be filled with air.

As shown in fig. 3, intended to cover the right leg or lower right limb L of the subject1The lower active part 4 of the compression suit 1 comprises an internal cuff 40, surrounding the right lower extremity L of the subject at the lower active part 41In place, the inner cuff can surround and apply a tightening force to the right thigh of the subject. The tightening cuff 40 can be in particular an inflatable cuff comprising an entrainment to allow the cuff to be held in position around the thigh of the subject and intended to be filled with air at a standard pressure of about 50 mmHg. The cinching cuff 40 is intended to allow assessment of the mobilized blood volume (or "venous bed") of a subject prior to a pressure application session, particularly LBPP, using the compression garment 1.

The procedure for assessing mobilizable blood volume can advantageously include: applying vein occlusion on the subject's right thigh using a cinching cuff 40, and measuring the pressure applied to the compression garment around the subject's right lower limb L1The change in the air pressure in the lower mobile part 4 forming the inflatable cuff, in particular the change in volume L of the right lower limb caused by the occlusion and its release, is measured by gas plethysmography1

In the case of LBPP, since this modulated blood volume determines the effectiveness of LBPP treatment for a subject, it is important to evaluate the modulated blood volume prior to applying a course of therapy with LBPP differential pressure of the compression garment 1. In particular, when the mobilized blood volume of the lower body of the subject is low, there is a risk that blood will be transferred to the upper body of the subject due to LBPP application, and thus cerebral blood vessels cannot be effectively reformed. In this case, it is advantageous to "fill" the venous network of the subject with a fluid, in particular with physiological saline, before applying the LBPP with the compression garment 1, in order to increase the mobilized blood volume. It is believed that when the mobilized blood volume of a subject assessed as described above is zero or less than a predetermined value, it is advantageously possible to inject 500mL of saline into the venous network of the subject prior to the LBPP procedure using compression garment 1.

Preferably, as shown in fig. 5, when placed on a subject, the compression garment 1 comprises a disposable protective fabric 8 located between the subject's body and each movable part 3, 4, 5. The protective fabric 8, for example with a weight per unit area of 40 to 170g/m, acts as a "second skin" to prevent irritation of the subject's skin due to contact with the movable parts 3, 4, 52The microfiber fabric of (1). Advantageously, the protective fabric 8 is applied in a removable manner on each of the internal fabric parts 33, 43, 53 with the mobile parts 3, 4, 5, while being kept taut by any suitable means, for example using entrainment, so as to prevent the appearance of folds that could irritate the skin of the subject. The protective fabric also prevents soiling of the movable parts 3, 4, 5, so that the pressure application suit 1 can be reused for different pressure application sessions without hygiene problems, as long as the protective fabric 8 used during a session is removed at the end of the session and replaced with a new protective fabric 8 in a later session.

Using the compression garment 1 as described above, the subject's abdomen A and lower extremities L are subjected to the "Positive lower body pressure" (LBPP) principle1、L2One example of a method of applying pressure includes the steps as described below.

First, the compression garment 1 is preferably placed on the subject in a non-inflated state of the compression garment, i.e. in a state in which each of the inflatable bladders 31, 41, 51 of the garment is not filled with air or is filled with very little air.

For this purpose, as shown in fig. 3, each of the movable parts 3, 4, 5 of the compression garment 1 is unfolded therewithThe configuration is positioned and the protective fabric 8 is applied to the inner fabric part 33, 43, 53 of each movable part 3, 4, 5. The abdominal activity part 3 of the pressure garment 1 is then placed at the position of the subject's abdomen a and the two lower activity parts 4, 5 are placed respectively at the lower limbs L of the subject1,L2At the location of (a). Each movable member 3, 4, 5 is then closed, moved from the deployed configuration into a tubular configuration around the respective body part of the subject, and adjusted around the respective body part of the subject using the entrainment strips 37, 38, 47, 48, 57, 58.

In the case of a bedridden subject or a subject suffering from quadriplegia, the design of the compression garment 1 allows it to be placed on a subject in a lying position. In this case, the compression garment 1 is positioned on the bed with each of its active parts 3, 4, 5 in the unfolded configuration and provided with the protective fabric 8, then the subject's back is placed on the compression garment 1, the subject's abdomen A is positioned at the position of the abdominal active part 3, the subject's lower limbs L are positioned1,L2Is positioned at the location of the respective lower movable part 4, 5 of the press garment. Each movable part 3, 4, 5 is then closed by moving from its deployed configuration into a tubular configuration around the respective body part of the lying subject and is adjusted around the respective body part of the subject using an entrainment strap 37, 38, 47, 48, 57, 58 which has been provided for this purpose at the front of the compression garment.

Then, a tuneable blood volume measurement can be performed on the subject equipped with the compression garment 1. For this purpose, a venous occlusion is applied at the base of the right thigh of the subject using a tightening cuff 40, and the right lower limb L resulting from this occlusion and its release is measured by plethysmography1The volume of (c) is changed. This can be, for example, an air plethysmography, which measures the air pressure variations in the lower movable part 4, which forms the right lower limb L around the subject1The inflatable oversleeve. Based on the value of mobilized blood volume thus assessed, saline can be injected into the venous network of the subject to increase mobilized blood volume and to initiate hemorrhagic shockThe effect of LBPP is improved at venous bed events.

Each bladder 31, 41, 51 of the presser suit 1 is then filled with air injection means 63, 64, 65 connected to the filling end pieces 36, 46, 56 until a measurement substantially equal to a predetermined interface pressure set value of each movable part is obtained by each interface pressure sensor 2 of said movable part for each movable part 3, 4, 5. In particular, according to one advantageous example of applying LBPP using the pressure garment 1, the predetermined interfacial pressure setting for the abdominal activity component 3 is 10mmHg, while the predetermined interfacial pressure setting for each lower activity component 4, 5 is 20 mmHg. The control unit 7 of the pressure garment 1 can be configured to fill the pockets 31, 41, 51 of the garment in an automatic manner.

The compression garment 1 is then controlled by means of the control unit 7 of the garment, automatically applying a constant and uniform pressure of 10mmHg to the abdomen A of the subject for a determined duration (for example a duration of 90 minutes), for each lower extremity L of the subject1、L2Applying a constant and uniform pressure of 20mmHg, the control unit of the garment is configured to selectively actuate the air injection means 63, 64, 65 as a function of the interface pressure measurements from the sensors 2, so as to maintain, for a determined duration, the interface pressure value measured by each sensor 2 equal to a predetermined interface pressure setpoint of the movable part 3, 4, 5 to which said sensor 2 is attached.

In the second embodiment shown in fig. 6, elements similar to those of the first embodiment are denoted by the same reference numerals. The compression garment 1 of the second embodiment differs from the compression garment of the first embodiment in that the adjustment means of the movable parts 3, 4, 5 on the subject's body are formed by a closed system of a plurality of tightening straps 37', 47', 57' and corresponding clips 38', 48', 58' used instead of the entrainment straps 37, 38, 47, 48, 57, 58. As shown in fig. 6, for each movable part 3, 4, 5, the closure system using the tightening straps 37', 47', 57 'and the clips 38', 48', 58' is distributed over the entire length of the movable part in the axial direction of the tubular configuration, so as to allow to adjust the encircling in a suitable manner over the entire length of the movable partSubject's corresponding body part A, L1、L2The perimeter of the movable parts 3, 4, 5.

In the third embodiment shown in fig. 7 and 8, elements similar to those of the first embodiment are denoted by the same reference numerals. The compression garment 1 of the third embodiment differs from the compression garment of the first embodiment in that the adjustment means of the movable parts 3, 4, 5 on the subject's body are not limited to longitudinally closed entrainment bands 37, 38, 47, 48, 57, 58. In this third embodiment, the adjustment device also comprises a sculpted seam 39, 49, 59 of the fabric of each movable element 3, 4, 5. The seam 39, 49, 59 of each movable part 3, 4, 5 is configured to utilize the shape of the movable part 3, 4, 5 to apply the movable part to the respective body part A, L of the subject during filling of the inflatable bladder 31, 41, 51 of the movable part with air1、L2. The seams 39, 49, 59 of each movable element 3, 4, 5 allow the movable element to better assume the shape of the corresponding body part of the subject. Further, as shown in fig. 8, the pressure applying garment 1 of the third embodiment surrounds the buttocks of the subject. The means covering the subject's buttocks can be an inflatable means, which can be filled with air, and in particular can correspond to an inflatable bladder, which is also useful as long as a constant and controlled pressure is also applied to the subject's buttocks to expel blood from the area. Alternatively, the component covering the subject's buttocks can be non-fillable.

As shown in the previous examples, the compression garment according to the present invention, which includes the interface pressure sensor on the inner wall of each of the movable parts of the garment, can automatically apply uniform and constant pressure to the abdomen and lower limbs of the subject. In particular, the compression garment according to the invention is well suited for applying pressure according to the "positive lower body pressure" (LBPP) principle, which involves a pressure difference applied to the abdomen and lower limbs of a subject. Due to the air tightness and flexibility of the fabric in each of the movable parts forming the compression garment, each movable part is able to act as an air chamber while maintaining a flexible structure, which brings a high degree of wearing comfort and ease of placing it on a subject, including bedridden or paralyzed subjects. The present invention provides the possibility of different sizes of the pressure garment, for example S, M, L, XL, and the presence of adjustment means for adjusting the pressure garment on each part of the body, also allowing the garment to adapt to the morphology of each subject, in order to contribute to the effect of the garment on the treatment by applying pressure, in particular according to the LBPP principle.

The invention is not limited to the examples described and shown. In particular, in the preceding example, each active part 3, 4, 5 of the presser garment comprises a single fillable bladder 31, 41, 51. Alternatively, the active parts of the garment according to the invention can each comprise any number of fillable bladders. Preferably, each fillable bladder of each movable part is therefore equipped with at least one interface pressure sensor. Furthermore, the number and arrangement of interface pressure sensors on each movable part of the pressure suit according to the invention can be different from what is described in the previous examples. The interface pressure sensors used can also have different dimensions to suit their location and can be of different types, in particular pneumatic sensors, electronic sensors or a combination of pneumatic and electronic sensors, etc. Finally, the compression garment of the present invention has been described above with respect to the application of pressure corresponding to the "positive lower body pressure" (LBPP) principle. Alternatively, it can be used to apply all types of pressure automatically to the abdomen and/or lower limbs of the subject, for example pressure varying over time, which can be automatically controlled by the control unit of the compression garment.

Applying "positive lower body pressure" (LBPP) by means of the compression garment according to the invention includes the following treatments, but is not limited to:

improving cerebrovascular recovery in different clinical situations

1-cerebral perfusion disorders regardless of the mechanisms that lead to the acute phase of cerebral ischemia:

ischemic stroke

-vasospasm.

2-subacute phase of cerebral ischemia resulting from persistent disturbance of cerebral perfusion to improve functional recovery:

ischemic stroke.

3-chronic cerebral ischemia caused by chronic disorders of cerebral perfusion:

vascular dementia.

4-improvement of ocular revascularization in different clinical situations:

acute phase of carotid occlusion

Anterior Ischemic Optic Neuropathy (AION)

Retinal artery occlusion

Chronic disorders of choroidal perfusion

Age-related macular degeneration (AMD).

5-use of LBPP to aid or increase delivery in a therapeutic agent for cerebral hypoperfusion in a blood perfusion zone, said therapeutic agent selected from the group comprising anticoagulants, fibrinolytic agents, radical traps, NO donors.

6-use of LBPP to assist or increase the delivery of therapeutic agents for ocular diseases in the perfusion zone of the blood stream, selected from the group comprising antioxidants, anti-inflammatory agents, trophic factors, apoptosis inhibitors and statins.

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