Device for detecting a blood loss

Abstract

The present disclosure relates to a device for detecting blood loss, which device is suitable for detecting blood loss during hemodialysis, the device comprising: - a frame (2) comprising a bottom (20) and two raised edges (21, 22) that extend in parallel in a longitudinal direction; - a blood-permeable flexible strip (3) comprising two longitudinal edges (31, 32) that are respectively rigidly attached to the two raised edges by fastening means, the strip being configured to support an upper limb of a user while keeping it at a distance from, and above the bottom of, the frame; - a module for detecting blood loss, the module comprising an electrical circuit (4) arranged between the bottom (20) of the frame and the flexible strip (3) at a distance from the flexible strip (3), the electrical circuit (4) being configured to detect blood loss when the lost blood passes through the blood-permeable flexible strip and is transferred, under the effect of gravity, onto the tracks of the electrical circuit (4).

Description

Description Title: Blood loss detection device

[0001] The present disclosure relates to a blood loss detection device suitable for detecting blood loss during hemodialysis. Technical field

[0002] This disclosure relates to the field of control equipment during the implementation of hemodialysis, and will advantageously find application in the field of hemodialysis carried out at the level of arteriovenous access by means of arteriovenous fistulas or even by arteriovenous bypasses.

[0003] However, this particular application of the invention is not limiting and the invention may be used for dialysis at the level of veno-venous approaches.

[0004] The present invention relates to the monitoring of patients undergoing hemodialysis. To compensate for renal insufficiency, the patient's blood is filtered by extrarenal purification using an artificial kidney or hemodialyzer.

[0005] This operation, called hemodialysis, must be carried out frequently and, depending on the patient, around 2 to 3 times per week and lasts 3 to 5 hours each time.

[0006] Given the duration of the operations, the patient cannot be continuously monitored by medical staff. Generally, the patient is installed by a responsible nurse who checks both the hemodialysis machine and the patient's condition. The nurse then returns periodically, preferably every half hour, to check the patient's comfort as well as physiological parameters such as blood pressure, pulse, blood sugar, weight, and veno-venous access.

[0007] The constraints of these dialyses are considerable for the patient. One constraint in particular lies in the connection of the patient allowing the transfer of blood by suction to the hemodialyzer and then its return to the patient.

[0008] To facilitate the preparation of this connection, several routes are possible, a first route at the level of the arteriovenous approaches and a second route at the level of the veno-venous approaches.

[0009] The first approach is to create an arteriovenous fistula or an arteriovenous bypass. This approach, requiring a fistula, is most commonly used when the patient requires long-term dialysis. Typically, the fistula is created on the patient's arm between the radial artery and vein. Creating a fistula allows for dialysis to be performed several times a week and increases the flow of blood drawn.

[0010] The second approach involves inserting either a single-lumen catheter or a double-lumen catheter at the veno-venous access points. The single-lumen catheter, generally reserved for emergency cases, allows blood to be aspirated, then treated and finally reinjected, while the double-lumen catheter allows the phases of aspirating the blood to be treated and injecting the purified blood to be carried out simultaneously.

[0011] The risk of hemorrhage during dialysis is not negligible, particularly in the event of a problem with the veno-venous or arterio-venous access or in the event of rupture, poor placement or leakage of the catheter.

[0012] The consequences of hemorrhage can be very serious and lead to the death of the patient given the high blood loss rates. It is therefore imperative to reliably detect blood loss and alert medical personnel as quickly as possible.

[0013] To do this, the patient is sometimes equipped with an alarm bell, however the patient cannot always warn in the event of an emergency situation, for example when he is asleep or following a fainting spell. Prior art

[0014] Alarm devices integrated into the hemodialyzer are also known, however these are not suitable for leak detection but for monitoring the patient's physiological parameters.

[0015] Detection devices are also known that are placed directly on the patient and that can detect a fluid leak. These detection devices are positioned like a bandage on the patient's skin at the catheter and consist of a layer of absorbent material comprising an electrical circuit, the latter being connected to an alarm such that when the electrical circuit is in contact with a liquid, the alarm is triggered.

[0016] This latter type of detection device is relatively satisfactory, however it also has various disadvantages. Indeed, these devices can generate false alarms, particularly in the event of a slight leak when the catheter is inserted or contact between the device and a non-blood liquid on the arm, for example cream or sweat.

[0017] Furthermore, the surface area of ​​these devices is reduced and the structure of these devices does not allow a leak to be detected beyond this surface area.

[0018] These devices must also be positioned on the patient's skin in a very sensitive area given the punctures performed; removal after use can therefore be painful and damage the patient's skin. Furthermore, the pressure exerted by the device on the needle can damage the fistula and render it inoperative. Another disadvantage of this type of device is that it masks the surrounding area so that the nurse cannot monitor the appearance of blood clots in the patient's vein.

[0019] Finally, these devices cannot be reused either in terms of the absorbent layer or the electrical circuit itself.

[0020] However, the present inventor, in particular from document WO201 5075353 (A1), knows a device for detecting blood loss during hemodialysis, said device comprising a frame, a textile band and a detection module, the frame allowing on the one hand, at its upper part, the fixing of the textile band capable of supporting an upper limb of the patient and on the other hand, in its lower part, the reception of at least part of the detection module so that the blood fluid coming into contact with the textile strip is transferred to an electrical circuit of the detection device.

[0021] Such a detection device makes it possible to monitor blood loss, with the patient's upper limb resting on the surface of the textile strip, advantageously without masking the arteriovenous (or veno-venous) approaches, thus allowing medical personnel to monitor the appearance of clots.

[0022] However, and according to the inventor's findings, such a detection device can be improved, in particular from the point of view of its ergonomics for the comfort of the patient, and / or from the point of view of safety. Summary

[0023] This disclosure improves the situation.

[0024] There is provided a blood loss detection device suitable for detecting blood loss during hemodialysis, comprising: - a frame comprising a base and two raised edges, extending in parallel in a longitudinal direction, - a flexible, blood-permeable strip, comprising two longitudinal edges, secured to the two raised edges respectively by fixing means, configured to support an upper limb of a user, keeping it at a distance and above the bottom of the frame, - a blood loss detection module, comprising an electrical circuit, arranged between the bottom of the frame and the flexible strip, at a distance from the flexible strip, the electrical circuit configured to detect blood loss when the blood loss passes through the flexible strip, permeable to blood, and is transferred by gravity onto the tracks of the electrical circuit.

[0025] According to the present disclosure, the attachment means comprise: -- a first fixing means, configured to hold the longitudinal edges of the flexible strip on a first longitudinal portion of the flexible strip; -- a second fixing means, configured to hold the longitudinal edges of the flexible strip on a second longitudinal portion of the flexible strip, -- articulation means between the first fixing means and the second fixing means, configured to pass the flexible strip from a first position to a second, stable, folded position, and in which the longitudinal edges of the first longitudinal portion of the flexible strip are contained in a first plane, and the longitudinal edges of the second longitudinal portion of the flexible strip are contained in a second plane, the first plane and the second plane inclined relative to each other by an angle of inclination a which is greater in the second, folded position than the angle of inclination a which is possibly zero in the first position.

[0026] The features set out in the following paragraphs may optionally be implemented. They may be implemented independently of each other or in combination with each other:

[0027] According to one embodiment, the first stable position is a planar position for which the longitudinal edges of the first longitudinal portion of the flexible strip and the longitudinal edges of the second longitudinal portion of the flexible strip are coplanar.

[0028] According to one embodiment, the angle α in the second folded position is between 10° and 90°, for example between 30° and 60°, for example 45°.

[0029] According to one embodiment, the fixing means comprise two attachment grooves of the first fixing means and two attachment grooves of the second fixing means, and in which the two longitudinal edges of the flexible strip respectively comprise two beads, of a dimension greater than the groove entrance, the attachment grooves and the beads being configured to allow the flexible strip to be put in place, by threading the beads into the attachment grooves of the first fixing means and of the second fixing means, from two openings at the longitudinal ends of the attachment grooves.

[0030] According to one embodiment, the first fixing means comprises two fixing arms articulated respectively to the raised edges of the frame via a first pivot connection of the articulation means, fixing arms along which the longitudinal edges of the first portion of flexible strip are fixed, the arms able to pass from a stable retracted position, folded against the raised edges of the frame in the first flat position to a deployed position where the fixing arms are inclined relative to the raised edges of the frame in the second, folded, stable position, and / or the second fixing means comprises two fixing arms respectively, articulated to the raised edges of the frame via a second pivot connection of the articulation means, fixing arms along which the longitudinal edges of the second portion of flexible strip are fixed, the arms being able to pass from a stable retracted position folded against the raised edges of the frame in the first flat position to a deployed position, where the fixing arms are inclined relative to the raised edges of the frame in the second, folded, stable position.

[0031] According to one embodiment, the first fixing means comprises, in addition to the two fixing arms articulated along the first pivot connection, two support arms articulated along a pivot axis distinct from the axis of the first pivot connection, the support arms being configured to move from a retracted position, the support arms then interposed between the fixing arms then in a stable retracted position and the raised edges to a deployed position in which the support arms are raised, configured to support the fixing arms in their deployed position.and / or the second fixing means comprises, in addition to the two fixing arms articulated along the second pivot connection, two support arms articulated along a pivot axis distinct from the axis of the second pivot connection, the support arms being configured to move from a retracted position, interposed between the fixing arms then in a stable retracted position, on the one hand, and the raised edges, on the other hand, to a deployed position in which the support and locking arms are raised, configured to support the fixing arms in their deployed position.

[0032] According to one embodiment, the two fixing arms of the first fixing means are articulated respectively to the raised edges of the frame via the first pivot connection at the proximal ends of the arms, the two arms being adjoining each other via a bridge of flexible material extending transversely to the arms, in particular of curved profile, at the distal ends of the arms, the assembly comprising the two arms and the bridge of flexible material forming an elastically deformable element, and in which the first pivot connection of the articulation means comprises indexing means allowing locking according to different inclinations of the arms around the first pivot connection, the indexing means comprising at least one indexing stud secured to at least one of the arms, or even two studs respectively secured to the two arms, and several adjustment openings, distributed angularly around the first pivot connection on the frame, the indexing stud being configured to be inserted selectively into one of the adjustment openings,and wherein the indexing means are configured to allow a change in the inclination of the arms around the first pivot axis by separating the arms of the deformable element so as to allow the indexing stud or each indexing stud to escape the adjustment opening, then by pivoting said deformable element around the first pivot connection so as to change the inclination until the indexing stud becomes locked in another of the adjustment openings under the elastic force of the deformable element, and / or the two fixing arms of the second fixing means are articulated respectively to the raised edges of the frame via the second pivot connection at the proximal ends of the arms, the two arms being attached to each other via a bridge of flexible material extending transversely to the arms, in particular of curved profile, at the distal ends of the arms,the assembly comprising the two arms and the bridge of flexible material forming an elastically deformable element, and in which the second pivot connection of the articulation means comprises indexing means allowing locking according to different inclinations of the arms around the first pivot connection, the indexing means comprising at least one indexing stud secured to at least one of the arms, or even two studs respectively secured to the two arms, and several adjustment openings, distributed angularly around the second pivot connection on the frame, the indexing stud being configured to be inserted selectively, in one of the adjustment openings, and in which the indexing means are configured to allow a change in the inclination of the arms around the second pivot axis by separating the arms from the deformable element so as to allow the indexing stud or each indexing stud to escape the adjustment opening, then by pivoting said deformable element around the first pivot connection so as to change the inclination until the indexing stud becomes locked in another of the adjustment openings under the elastic force of the deformable element.

[0033] According to one embodiment, the first pivot connection of the first holding means comprises two pivot axes projecting from the arms, one towards the other, configured to be inserted into two openings of the frame, respectively arranged on the two raised edges, or vice versa, and in which said deformable element is configured to be assembled to the frame by insertion of the two pivot axes which have radial projections configured to be inserted respectively through the two openings of the first pivot connection when the radial projections are aligned with radial notches of the openings in a determined angular position of the deformable element relative to the frame, the pivot axes prevented from coming out of the openings by pivoting of the deformable element when the radial projections of the pivot axes are offset from the radial notches and constitute stops blocking the extraction of the pivot axes from the openings of the frame,and / or the second pivot connection of the second holding means comprises two pivot axes projecting from the arms towards each other, configured to be inserted into two openings of the frame, respectively arranged on the two raised edges, or vice versa, and in which said deformable element is configured to be assembled to the frame by inserting the two pivot axes which have radial projections configured to be inserted respectively through the two openings of the second pivot connection when the radial projections are aligned with radial notches of the openings in a determined angular position of the deformable element relative to the frame, the pivot axes prevented from coming out of the, pivoting openings of the deformable element when the radial projections of the pivot axes are offset from the radial notches and constitute stops blocking the extraction of the pivot axes from the openings of the frame.

[0034] According to one embodiment, the bottom and the raised edges of the gutter form a sealed gutter, and in which the electrical circuit of the detection module is flexible, pressed against the bottom and the raised edges of the frame.

[0035] According to one embodiment, the tracks of the electrical circuit comprise: - a first portion of circuit forming a first comb and, - a second circuit portion forming a second comb and in which the teeth of the first comb and the teeth of the second comb are intertwined and in which the detection module is configured to ensure the detection of blood loss when the blood in contact with the tracks ensures a short circuit between the teeth of the first and second comb, or when the blood above the tracks, possibly covered with an electrical insulator, modifies the capacitance of the circuit.

[0036] According to one embodiment, the blood loss device has a removable cover system comprising: - a first cover configured to be removably attached to the first attachment means configured to cover the first longitudinal portion of the flexible strip, as well as a first portion of the member supported by said first longitudinal portion, - a second cover configured to be removably attached to the second attachment means configured to cover the second longitudinal portion of the flexible strip, as well as a second portion of the member supported by said second longitudinal portion and in which said first cover and said second cover are configured to move relative to each other according to the movement permitted by the articulation means between the first attachment means and the second attachment means (6), when the flexible strip has passed from the first position to the second stable folded position.

[0037] According to one embodiment, the first cover has an inverted U-shaped section, along a plane perpendicular to a longitudinal direction of the first longitudinal portion and the second cover has an inverted U-shaped section along a plane perpendicular to a longitudinal direction of the second longitudinal portion.

[0038] According to one embodiment, the hood system comprises an intermediate hood portion extending the first hood and / or the second hood providing coverage between the first hood and the second hood, in particular at the elbow of the upper limb,

[0039] According to one embodiment, the intermediate cover is flexible and configured to deform when the flexible strip is moved from the first position to the second stable folded position.

[0040] According to one embodiment, the hood system, including the first hood, the second hood and the intermediate hood (are formed by two separate parts, with a first part comprising the first hood and a second part comprising the second hood, the flexible intermediate hood being an extension of either the first hood or the second hood.

[0041] According to another embodiment, the hood system, comprising the first hood, the second hood and the flexible intermediate hood, forms a single-piece hood system.

[0042] According to one embodiment: - the first cover comprises coupling parts, for example downwardly projecting tabs, configured to cooperate removably, by elastic interlocking, with complementary shaped parts of the two arms of the first fixing means, - the second cover comprises coupling parts, for example downwardly projecting tabs, configured to cooperate removably, by elastic interlocking, with complementary shaped parts of the two arms of the second fixing means. Brief description of the drawings

[0043] Other features, details and advantages will become apparent upon reading the detailed description below, and upon analyzing the attached drawings, in which: Fig. 1

[0044] [Fig. 1] is a perspective view of a blood loss detection device according to the present disclosure in a first, substantially planar, position of the flexible band. Fig. 2

[0045] [Fig. 2] is a view of Figure 1 when the flexible strip is removed. Fig. 3

[0046] [Fig. 3] is a sectional view, along a plane perpendicular to the longitudinal axis of the device, illustrating more particularly the hooking grooves configured to hold the longitudinal edges of the flexible strip Fig. 4

[0047] [Fig. 4] is a schematic view illustrating the retention of beads of the longitudinal edges of the flexible strip in the attachment grooves. Fig. 5

[0048] [Fig. 5] is a view of the device of Figure 1, in the second folded position, by raising two fixing arms around a pivot connection, to approximately 45, then raising two support arms supporting the two fixing arms in the raised position. Fig. 6

[0049] [Fig. 6] is a view of Fig. 5, when the flexible strip is removed. Fig. 7

[0050] [Fig. 7] is a sectional view, illustrating the angle of inclination between a first plane and a second plane in the second folded position of the fixing means, as well as a projection at the distal end of the support arm which penetrates a complementary cavity at the distant end of the fixing arm then in the raised position, to ensure stable support of the fixing arm by the holding arm. Fig. 8

[0051] [Fig. 8] is a diagram illustrating the operation of the detection device, and in particular a test mode, prior to the blood loss detection mode, configured to ensure the good integrity of the detection module, in order to monitor blood loss, in the detection mode. Fig. 9

[0052] [Fig. 9] illustrates a configuration of the electrical circuit allowing the implementation of a test of the integrity of the electrical circuit, whether in particular prior to the detection mode during the test mode, or in particular during the detection mode, in parallel with the detection of blood loss. Fig. 10

[0053] [Fig. 10] illustrates a perspective view of a blood loss detection device according to the present disclosure in a first, substantially planar position of the flexible strip and according to a second embodiment. Fig. 11

[0054] [Fig. 11] is a view of Figure 10, when the first fixing means is hidden, illustrating the openings of the first pivot connection on the raised edges of the frame, as well as the adjustment openings of the indexing means, distributed around the axis of the first pivot connection, allowing different inclinations of the arms of the first fixing means, relative to the frame. Fig. 12

[0055] [Fig. 12] illustrates, on the one hand, on the left a detailed view of the first fixing means which comprise two parallel arms linked by a bridge of flexible material, arched at the distal ends of the arms, the proximal ends of the arms comprising two pivot axes, each cylindrical, with radial projection, cooperating with openings in the frame, bearing radial notches, ensuring a bayonet attachment between the pivot pins and the openings, and on the other hand, on the right, a sectional diagram of the assembly between the pivot pin bearing the radial projection and the opening bearing the radial notch. Fig. 13

[0056] [Fig. 13] is an exploded view of the first fastening means illustrated in Figure 12, resulting from the assembly of three injection-molded parts illustrated in that figure. Fig. 14

[0057] [Fig. 14] is a schematic view of the detection mode according to another embodiment based on the measurement of an electrical capacitance on the detection circuit. FIG 15

[0058] [Fig. 15] is a perspective view of a blood loss detection device according to the present disclosure, in a planar position, of the flexible strip (not shown), and according to a third embodiment notably presenting a cover system, comprising a first cover removably fixed on the two arms of the first fixing means, and a second cover removably fixed on the two arms of the second fixing means, an intermediate, flexible cover, in extension of the second cover, covering the intermediate space between the first and the second cover. FIG 16

[0059] [Fig. 16] is a perspective view of the blood loss device, after tilting the two arms of the first fixing means by rotation of the arms around the first pivot connection, causing simultaneous movement of the first cover, and while the arms of the second fixing means and the second cover remain fixed, the flexible intermediate cover deforming under the engagement of the first cover. Description of the embodiments

[0060] The drawings and description below contain, for the most part, elements of a certain character. They may therefore not only serve to better understand this disclosure, but also contribute to its definition, if necessary.

[0061] Also, the present disclosure relates to a blood loss detection device suitable for detecting blood loss during hemodialysis.

[0062] The detection device comprising: - a frame 2 comprising a base 20 and two raised edges 21, 22, extending in parallel in a longitudinal direction, - a flexible strip 3, such as a textile strip, permeable to blood, comprising two longitudinal edges 31, 32, secured to the two raised edges respectively by fixing means, the flexible strip being configured to support an upper limb of a user such as the arm and / or the forearm, keeping it at a distance and above the bottom of the frame, - a blood loss detection module, comprising an electrical circuit 4, arranged between the bottom 20 of the frame and the flexible strip 3, at a distance from the flexible strip 3, the electrical circuit 4 configured to detect blood loss when the blood loss passes through the flexible strip, permeable to blood, and is transferred in particular by gravity onto the tracks of the electrical circuit 4.

[0063] The detection device according to the present disclosure makes it possible to monitor the blood loss of a patient, the upper limb supported from below, while the hemodialysis puncture point, located on top, is left free, not masked by the flexible band, advantageously allowing monitoring by medical personnel of the arteriovenous accesses (or the veno-venous accesses).

[0064] According to a claimed embodiment, the fixing means comprise: - a first fixing means 5, configured to hold the longitudinal edges 31, 32 of the flexible strip 3 on a first longitudinal portion P31 of the flexible strip; - a second fixing means 6, configured to hold the longitudinal edges of the flexible strip on a second longitudinal portion P32 of the flexible strip, - articulation means 7 between the first fixing means 5 and the second fixing means 6, configured to pass the flexible strip 3 from a first position P1 to a second stable folded position P2, distinct from the first position.

[0065] According to such an embodiment, the longitudinal edges 31, 32 of the first longitudinal portion P31 of the flexible strip are contained in a first plane PL1 and the edges and the longitudinal edges 31, 32 of the second longitudinal portion P32 of the flexible strip are contained in a second plane PL2, the first plane PL1 and the second plane PL2 inclined relative to each other by an angle of inclination a which is greater in the second position P2 than the angle of inclination a which is possibly zero in the first position P1.

[0066] Thus, figure 2 illustrates the first position P1 of the flexible strip for which the angle a can be zero, namely that the first stable position P1 can possibly be a flat position for which the longitudinal edges 31, 32 of the first longitudinal portion P31 of the flexible strip 3 and the longitudinal edges of the second longitudinal portion P32 of the flexible strip 3 are coplanar, as illustrated for information purposes in figure 1.

[0067] Figure 5 illustrates the detection device in its second folded position P2, inclined by said angle of inclination a which is greater than that of the first position P1. The angle a in the second folded position P2 is between 10° and 90°, for example between 30° and 60°, for example 45°, such as for example 30°, 60° and 90°.

[0068] The articulation means 7, thus configured to move the flexible band 3 from the first position P1 to the second folded position P2, improve the ergonomics compared to the teaching of the state of the art according to WO2015075353 (A1) by making it possible to adapt the support of the flexible band to the bend of the elbow of the upper limb.

[0069] In particular, and in the second folded position P2 of the flexible band, the forearm and the arm of the user's upper limb can be respectively supported by the first longitudinal portion P31 of the band flexible (supporting for example the forearm) and the second longitudinal portion P32 of the flexible band (supporting for example the arm), and even when the elbow is bent, as encountered in particular in a sitting position of the patient.

[0070] The first flat position P1 can, on the contrary, be adapted in other configurations of support of the upper limb, and for example when the patient's upper limb is fully unfolded, as encountered in particular in a lying position of the patient.

[0071] According to one embodiment, the fixing means comprise two hooking grooves 51, 52 of the first fixing means 5 and two hooking grooves 61, 62 of the second fixing means 6.

[0072] The two longitudinal edges 31, 32 of the flexible strip 3 respectively comprise two beads BR, of a dimension greater than the groove entrance. The attachment grooves 51, 52; 61, 62 and the beads BR are then configured to allow the flexible strip to be put in place, by threading the beads BR into the attachment grooves 51, 52; 61, 62 of the first fixing means 5 and of the second fixing means 6, from two openings at the longitudinal ends of the attachment grooves. The flexible strip is removed by extracting the beads from the attachment grooves.

[0073] According to one embodiment, the first fixing means 5 comprises two fixing arms 53, 54 articulated respectively to the raised edges 21, 22 of the frame via a first pivot connection 70 of the articulation means 7, fixing arms 53, 54 along which the longitudinal edges of the first portion P31 of flexible strip are fixed in particular via a hooking groove 51 of the first arm 53 and via a hooking groove 52 of the second arm 54.

[0074] The arms 53,54 are configured to move from a stable retracted position, folded against the raised edges 21,22 of the frame in the first position P1, possibly flat, to a deployed position where the arms 53,54 are inclined relative to the raised edges of the frame 2 in the second position P2, folded, stable, in particular said angle of inclination a.

[0075] Alternatively or additionally, the second fixing means 6 comprises two fixing arms 63, 64 respectively, articulated to the raised edges 21, 22 of the frame via a pivot connection, in particular a second pivot connection 71 of the articulation means 7, fixing arms 63, 34 along which the longitudinal edges of the second portion P32 of flexible strip are fixed, in particular via a hooking groove 61 of the first arm 63 and via a hooking groove 62 of the second arm 64.

[0076] The arms 63, 44 are configured to move from a stable retracted position folded against the raised edges 21, 22 of the frame in the first position P1, possibly flat, to a deployed position, where the arms 63, 64 are inclined relative to the raised edges 21, 22 of the frame in the second position P2, folded, stable, in particular said angle of inclination a.

[0077] According to one embodiment, the first fixing means 5 comprises the two articulated fixing arms 53, 54, and the second fixing means comprises the two articulated fixing arms 63, 64, which advantageously makes it possible to use the detection device, on the right or left, of the patient, indifferently.

[0078] The two fixing arms 53, 54 of the first fixing means 5 can be raised into the second position P2, while the two fixing arms 63, 64 of the second fixing means 6 are folded, and as illustrated in FIG. 5, in particular when the detection device is used on the patient's right upper limb, and according to FIG. 5, while maintaining a human machine interface (HMI) oriented outwards, to the right of the patient.

[0079] Conversely, the two fixing arms 53, 54 of the first fixing means 5 can be folded, in the second position P2, while the two fixing arms 63, 64 of the second fixing means 6 are raised (not illustrated) when the detection device is used on the patient's left upper limb, and always keeping the human machine interface (HMI) oriented outwards, to the left of the patient.

[0080] The detection device can be used on either the left or right upper limb, always maintaining a good orientation of the human machine interface (HMI) towards the outside.

[0081] According to a first embodiment illustrated in Figures 1 to 8, the first fixing means 5 comprises, in addition to the two fixing arms 53, 54, articulated along the first pivot connection 70, two support arms 55, 56 articulated along a pivot axis 72 distinct from the axis of the first pivot connection 70.

[0082] These support arms 55,56 are configured to move from a retracted position, the support arms 55,56 then interposed between, on the one hand, the fixing arms 53,54, then in a stable retracted position, and on the other hand, the raised edges 21,22 and as illustrated in FIG. 2 to a deployed position in which the support arms 55,56 are raised configured to support the fixing arms 53,54 in their deployed position.

[0083] Additionally or alternatively, the second fixing means 6 comprises, in addition to the two fixing arms 63, 64, articulated along the second pivot connection 71, two support arms 65, 66, articulated along a pivot axis 73 distinct from the axis of the second pivot connection 71.

[0084] The support arms 65,66 are configured to move from a retracted position, interposed, on the one hand, between the fixing arms 63,64 then in a stable retracted position and on the other hand, the raised edges 21,22 to a deployed position in which the support arms 65,66 are raised configured to support the fixing arms 63,64 in their deployed position.

[0085] In Figure 7, and in general, it is noted that the support arms 55, 56; 65, 66 are articulated respectively along the pivot axis 72; 73 at one longitudinal end of the arms, called the proximal end EP; the other longitudinal end, called the distal end ED, comprising a projection S configured to come into a complementary cavity of the fixing arm 53, 54; 63, 64, at one end of the fixing arm which is located opposite the end of the fixing arm articulated by the pivot connection, namely the first pivot connection 70 or second pivot connection 71 in the inclined position of the fixing arms.

[0086] Conversely, the projection may be provided on the fixing arm 53,54; 63,64 and the complementary cavity at the distal end of the support arm 55,56; 65,66 for an identical result, namely that the insertion of the projection S into the cavity allows the support arm to support the fixing arm in a stable inclined position.

[0087] To release the fixing arm 53,54; 63,64 then thus supported in the raised position by the support arm 55,56; 65,66, it is necessary to raise the fixing arm further, in order to release the projection from the cavity, then to lower the support arm, then successively the fixing arm.

[0088] According to a second embodiment illustrated for information purposes in Figures 10 to 13, the two fixing arms 53, 54 of the first fixing means 5 can be articulated respectively to the raised edges 21, 22 of the frame 2 via the first pivot connection 70 at the proximal ends EP of the arms, the two arms being attached to each other via a bridge of flexible material 57 extending transversely to the arms, at the distal ends ED of the arms. The bridge of flexible material 57 takes in particular a concave arcuate shape, so as not to constitute an obstacle for the arm or forearm of the patient supported by the flexible band.

[0089] The assembly comprising the two arms 53, 54 of the first fixing means 5 and the flexible material bridge 57 forms an elastically deformable element allowing the two arms to move apart, by elastic deformation of the flexible material bridge 57.

[0090] The first pivot connection 70 of the articulation means 7 also comprises indexing means allowing locking according to different inclinations of the arms 53, 54 around the first pivot connection 70, the indexing means comprising at least one indexing stud 58 secured to at least one of the arms 53, 54 or even two studs 58 respectively secured to the two arms 53, 54 projecting inwards, and several adjustment openings Oi distributed angularly around the first pivot connection 70 on the frame 2.

[0091] The indexing stud 58 is configured to be selectively inserted into one of the adjustment openings Oi to allow several tilt adjustments, for example to the values ​​0°, 30°, 60° and 90°.

[0092] The indexing means are configured to allow a change in the inclination of the arms 53, 54 around the first pivot axis 70 by separating the arms 53, 54 from the deformable element so as to allow the indexing stud or each indexing stud 58 to escape the adjustment opening Oi, then by pivoting said deformable element around the first pivot connection 70 so as to change the inclination until the indexing stud becomes blocked in another of the adjustment openings under the elastic force of the deformable element.

[0093] Alternatively or additionally, the two fixing arms 63, 64 of the second fixing means 6 can be articulated respectively to the raised edges 21, 22 of the frame 2 via the second pivot connection 71 at the proximal ends EP of the arms, the two arms being attached to each other via a bridge of flexible material 67 extending transversely to the arms 63, 64, in particular of curved profile, at the distal ends ED of the arms. The bridge of flexible material 67 takes in particular a concave arcuate shape, so as not to constitute an obstacle for the patient's arm supported by the flexible band.

[0094] The assembly comprising the two arms 63, 64 and the flexible material bridge 67 forms an elastically deformable element allowing the two arms to move apart, by elastic deformation of the flexible material bridge 67.

[0095] The second pivot connection 71 of the articulation means 7 comprises indexing means allowing locking according to different inclinations of the arms 63, 64 around the first pivot connection 71, the indexing means comprising at least one indexing stud (not illustrated) secured to at least one of the arms 63, 64, or even two studs respectively secured to the two arms 63, 64, and several adjustment openings Oi distributed angularly around the second pivot connection 71 on the frame 2.

[0096] The indexing stud is configured to be selectively inserted into one of the adjustment openings Oi, to allow several inclinations of the arms 63, 64, for example to the values ​​0°, 30°, 60° and 90°.

[0097] The indexing means are advantageously configured to allow a change in inclination of the arms 63,64 around the second pivot axis 71 by spacing the arms 63,64 away from the deformable element so as to allow the stud indexing or each indexing stud 58 to escape the adjustment opening Oi, then by pivoting said deformable element around the second pivot connection 71 so as to change the inclination until the indexing stud comes to lock in another of the adjustment openings under the elastic force of the deformable element.

[0098] According to this second embodiment, the first pivot connection 70 of the first holding means 5 may comprise two pivot axes Ap projecting from the arms 53, 54, one towards the other, configured to be inserted into two openings Op of the frame 2, respectively arranged on the two raised edges, or vice versa, namely that the openings are on the arms 53, 54 and the pivot axes on the frame 2.

[0099] Said deformable element is configured to be assembled to the frame 2 by inserting the two pivot axes Ap which have radial projections configured to be inserted respectively through the two openings Op of the first pivot connection 70 when the radial projections are aligned with radial notches of the openings Op in a determined angular position of the deformable element relative to the frame 2 around the first pivot connection 70, the pivot axes being prevented from leaving the openings Op by pivoting of the deformable element when the radial projections Sr of the pivot axes Ap are offset from the radial notches Er, constituting stops blocking the extraction of the pivot axes from the openings Op of the frame.

[0100] To allow the insertion of the pivot axes Ap into the openings Op of the frame, the deformable element is slightly deformed by moving the distal ends EP of the arms apart, by elastic deformation of the flexible material bridge 57.

[0101] For the determined angular position, an angular position will be chosen which does not correspond to a position of use, or even of adjustment of the arms 53, 54, for example at 120°.

[0102] Alternatively or additionally, the second pivot connection 71 of the second fixing means 6 may comprise two pivot axes Ap projecting from the arms 63, 64, one towards the other, configured to be inserted into two openings Op of the frame, respectively arranged on the two raised edges, or vice versa, at know that the openings are on arms 63, 64 and the pivot axes on frame 2.

[0103] Said deformable element is configured to be assembled to the frame 2 by inserting the two pivot axes Ap which have radial projections configured to be inserted respectively through the two openings Op of the second pivot connection 71 when the radial projections are aligned with radial notches of the openings Op in a determined angular position of the deformable element relative to the frame 2, the pivot axes prevented from coming out of the openings Op by pivoting of the deformable element when the radial projections Sr of the pivot axes Ap are offset from the radial notches Er and constitute stops blocking the extraction of the pivot axes Ap from the openings Op of the frame.

[0104] To allow the insertion of the pivot axes Ap into the openings Op of the frame, the deformable element is slightly deformed by moving the distal ends EP of the arms apart, by elastic deformation of the flexible material bridge 67.

[0105] For the determined angular position, an angular position will be chosen which does not correspond to a position of use, or even of adjustment of the arms 63, 64, for example at 120°.

[0106] For manufacturing reasons, it is noted as illustrated in figure 13 that the deformable element (of the first fixing means 5 or of the second fixing means 6) can result from the assembly of three parts typically injection molded, and not from a single molded part due to the undercuts formed in particular by the design of the attachment grooves, and which prevents demolding.

[0107] A first injection-molded part forms the flexible material bridge 57, a first half 530 of the arm 53 and a second half of the arm 54, as well as the proximal ends Ep forming the pivot axes Ap and indexing stud 58, and a second part 531 forming the other half of the arm 53 (left) and a third part 541 forming the other half of the arm 54 (right). The hooking groove 51 is obtained by joining the first part and the second part 531, formed for half, according to a plane of symmetry passing through the axis of the groove 51 on the first part and the second part. The hooking groove 52 is obtained by joining the first part and the third part 541, formed for half, according to a plane of symmetry passing through the axis of the groove 52 on the first part and the second part. A similar construction in three injection-molded parts can be obtained for the second fixing means 6. The different parts can have complementary shapes to ensure assembly by interlocking and / or by gluing.

[0108] It is also noted that, in general, the fixing arms 53, 54 of the first fixing means 5 may have openings O forming loops for a strap (not illustrated) intended to pass over the upper limb, holding it against the first longitudinal portion P31 of the flexible band.

[0109] Similarly, the fixing arms 63, 64 of the second fixing means 6 may have openings O forming loops for a strap (not shown) intended to pass over the upper limb, holding it against the second longitudinal portion P32 of the flexible band.

[0110] According to one embodiment, the bottom 20 and the raised edges 21, 22 of the gutter form a fluid-tight gutter. The electrical circuit of the detection module is flexible, for example pressed against the bottom 20 and the raised edges 21, 22 of the frame. The electrical circuit extends lengthwise below the flexible strip 3, and preferably over its entire length, and possibly also over its entire width.

[0111] According to one embodiment, illustrated in Figure 9 or another embodiment illustrated in Figure 14, the tracks of the electrical circuit comprise: - a first portion of circuit forming a first comb Pg1 and, - a second circuit portion forming a second comb Pg2 and in which the teeth of the first comb Pg1 and the teeth of the second comb are intertwined.

[0112] According to the embodiment illustrated in Figure 9, an electrical resistor R1 may preferably connect the first comb Pg1 and the second comb Pg2. The detection module may be configured to ensure the detection of blood loss when the blood in contact with the tracks provides a short circuit between the teeth of the first and second comb, in parallel with the electrical resistance R1. The teeth of the combs (first and second Pg1 and Pg2) are preferably oriented along a longitudinal axis of the armature 2.

[0113] In particular, the first portion of the circuit forming the first comb Pg1 is subjected to an electrical potential V (which is 5 Volts for information purposes in Figure 9) and the second portion of the circuit forming the second comb Pg2 is connected to ground via a second electrical resistor R2, at which the detection module reads the voltage llref.

[0114] The detection module is configured to trigger an audible and / or visual alarm indicating blood loss, at least in the detection mode of the device, when the voltage reading Uref across the terminals of the second resistor is strictly greater than a low threshold value which is equal to R2*VZ (R1 +R2) + p, for example equal to the electrical potential V

[0115] Advantageously, such a circuit allows the implementation of a fault detection of the electrical circuit: for this purpose the detection module is configured to trigger an audible and / or visual alarm indicating a fault in the detection module when the voltage reading Uref across the terminals of the second resistor R2 is strictly lower than a low threshold value equal to R2*V / (R1+R2)-s. Such fault detection makes it possible to signal, for example, a break in the tracks of the electrical circuit.

[0116] According to one embodiment, the detection device comprises a power supply for the detection module, the detection module comprising instructions recorded in a memory of a microcontroller implementing a mode for testing the integrity of the detection module, and said mode for detecting blood loss.

[0117] The integrity test mode is implemented, each time the mains is switched on, the integrity test mode including: - a reading of voltage Uref by the microcontroller at the terminals of the second resistor R2, - a switch authorized by the microcontroller from the integrity test mode to the blood loss detection mode when the voltage reading Uref at the terminals of the second resistance is between a low threshold value, equal to R2*V / (R1 +R2) - si and a high threshold value equal to R2*V / (R1 +R2) + s2 .

[0118] The functional diagram in Figure 8 illustrates such operation.

[0119] When the detection device is powered up, the detection device is in MN mode, allowing in particular the cleaning of the electrical circuit tracks, and without the risk of triggering an alarm, whether an alarm indicating the detection of blood loss, or a sensor fault indicator alarm.

[0120] The tracks can be cleaned by an operator. Then pressing a BP button on a human machine interface HMI allows switching to an MT test mode where the microcontroller checks that the voltage reading Uref across the second resistor R2 is between a low threshold value, equal to R2*V / (R1 +R2) - si and a high threshold value or equal to R2*V / (R1 +R2) + s2, indicating good integrity of the electrical circuit.

[0121] The success of the test can be signaled by an indicator (light and / or sound) on the human-machine interface, when the reading is between the low threshold value and the high threshold value. On the contrary, the failure of the test, when the reading goes outside this range, can be signaled by a visual and / or sound alarm. In the event of failure, the microcontroller prohibits switching to blood loss detection mode.

[0122] In the event of a successful test, a subsequent press on the BP button allows the transition to the MD detection mode. In the DS detection step, cyclic, implemented periodically by the microcontroller, a voltage reading Uref at the terminals of the second resistor R2 strictly greater than the low threshold value which is equal to R2*V / (R1 +R2) + |3, indicates detection of blood loss, the microcontroller triggering an audible and / or visual alarm AL “blood loss detection”.

[0123] In the absence of blood loss detection, the detection step is repeated in cycles, periodically, as long as blood loss is not detected by the microcontroller, with implementation, at each reading cycle, of a verification that the voltage reading across the second resistor R2 is between the low threshold value, equal to R2*V / (R1 +R2) - si and the high threshold value greater than R2*V / (R1 +R2) + s2, indicating good integrity of the electrical circuit, namely when the voltage reading llref at the DS detection step is not in a value greater than R2*V / (R1 +R2) + [3 indicating blood loss at the DC fault detection step.

[0124] If the reading goes outside the low and high threshold range, indicating a fault in the detection module, the blood loss detection mode is stopped; a “detection module fault” alarm is triggered.

[0125] According to the other embodiment illustrated in Figure 14, the detection of the fluid can be carried out by measuring the capacitance of the circuit between the two combs Pg1 and Pg2 when a fluid covers the tracks. This mode is advantageous compared to that of Figure 9, in that it does not require contact between the conductive tracks of the circuit and the fluid (for example blood). This advantageously makes it possible to cover the tracks (the first comb Pg1 and the second comb Pg2) with a protective film protecting them in particular from corrosion.

[0126] Detection is carried out by an MC sensor module which makes it possible to distinguish a first capacity, indicating a dry environment for example 50 pF and a second capacity of a humid environment for example 150 pF.

[0127] The sensor module MC may include a phase comparator which provides a phase comparison between a signal S1 generated by a microcontroller supplying the first comb Pg1 and a signal S2 received on the second comb Pg2. The measured capacitance is compared to a reference capacitance and generates a potential difference when a deviation is detected.

[0128] The sensor module also includes a voltage comparator, which amplifies the potential difference, followed by a peak detector, which allows all the peaks on the previous stages to be summed, which can then be followed by an isolation stage.

[0129] An MT test mode is possible obtained by adding a Cref capacitance to the circuit, by closing the switch It during the test. This Cref capacitance simulates the presence of a fluid and allows to check the correct functioning of the sensor module. This embodiment with sensor module can also obey the functional diagram of figure 8.

[0130] When the detection device is powered up, the detection device is in MN mode, allowing in particular the cleaning of the electrical circuit tracks, and without the risk of triggering an alarm, whether an alarm indicating the detection of blood loss, or a sensor fault indicator alarm.

[0131] The tracks can be cleaned by an operator. Then pressing a BP button on a human machine interface (HMI) allows switching to an MT test mode where the microcontroller checks that the reading of the Cref capacitance is detected by the sensor module with a signal at the sensor output indicating fluid detection.

[0132] The success of the test can be signaled by an indicator (light and / or sound) on the human-machine interface. Conversely, the failure of the test can be signaled by a visual and / or sound alarm. In the event of a failure, the microcontroller prohibits switching to blood loss detection mode.

[0133] In the event of a successful test, a subsequent press on the BP button allows the transition to the MD detection mode. In the DS detection stage, cyclic, implemented periodically by the microcontroller, a reading by the sensor module of a capacity greater than a reference indicates blood loss, with detection of an audible and / or visual alarm /

[0134] In the absence of detection of blood loss, the detection step is renewed in cycles, periodically, as long as blood loss is not detected by the microcontroller, preferably with implementation, at each reading cycle, of a verification of the correct functioning of the sensor module, by closing the switch It and implementing the aforementioned test.

[0135] In the event of a detection module fault, the blood loss detection mode is stopped: a “detection module fault” alarm is triggered.

[0136] Generally speaking; the device may also include, as an accessory, a controlled clamp (not shown), typically offset from the frame 2 of the device which is normally open. This clamp is actuated upon closing, typically electrically by the detection module, in the case of blood loss detection, to clamp the flexible hemodialysis tube.

[0137] The clamped tube then prevents the internal circulation of fluid, and thus hemodialysis. This clamp advantageously makes it possible to immediately stop the hemorrhage as soon as blood loss is detected by the detection module.

[0138] According to one embodiment, the blood loss detection device may comprise a removable cover system comprising: - a first cover CP1 configured to be removably fixed on the first fixing means 5 configured to cover the first longitudinal portion P31 of the flexible strip, as well as a first portion of the upper limb (for example the arm or the forearm) supported by said first longitudinal portion P31, - a second cover CP2 configured to be removably attached to the second attachment means 6 configured to cover the second longitudinal portion P32 of the flexible band, as well as a second portion of the upper limb (for example the forearm or the arm) supported by said second longitudinal portion P32, and preferably covering the hemodialysis puncture point and the hemodialysis equipment at this level, in particular the catheter or the fistula.

[0139] The first cover CP1 and said second cover CP2 are advantageously configured to move relative to each other according to the movement permitted by the articulation means 7 between the first fixing means 5 and the second fixing means 6, when the flexible strip 3 has passed from the first position P1 to the second, folded, stable position P2.

[0140] Such a hood system advantageously makes it possible to cover the area of ​​the upper limb at the level of the hemodialysis puncture point, and thus in particular to protect this area by avoiding or at least greatly limiting the risk of tearing of the material at this level, which could trigger blood loss.

[0141] For example, in the case of long-term hemodialysis, a textile blanket can be placed over the patient during hemodialysis to keep them warm. The hood system then prevents the hemodialysis equipment from catching on the blanket, causing a risk of tearing, and therefore blood loss, when the blanket is handled.

[0142] Furthermore, the hood system prevents a disoriented patient from gaining access to the puncture area and tearing off the hemodialysis equipment at this point.

[0143] Generally, the first cover CP1 has an inverted U-shaped section, along a plane perpendicular to a longitudinal direction of the first longitudinal portion P3 and the second cover CP2 has an inverted U-shaped section along a plane perpendicular to a longitudinal direction of the second longitudinal portion P32.

[0144] According to one embodiment, the hood system may comprise an intermediate hood portion CPI extending the first hood CP1 and / or the second hood CP2 providing coverage between the first hood CP1 and the second hood CP2, in particular at the elbow of the upper limb. The intermediate hood portion CPI covers the connection zone between the two longitudinal portions P31, P32, at which the elbow is located.

[0145] The intermediate cover CPI is typically flexible, configured to deform when the flexible strip 3 has passed from the first position P1 to the second position P2, the stable folded intermediate cover CPI then being constrained by the two covers CP1, CP2 coming together, during its compression, or conversely by deployment, during an inverse movement, by the two covers CP1, CP3 moving apart.

[0146] According to an embodiment illustrated in figures 15 and 16, the hood system, including the first hood, the second hood and the intermediate hood CPI are formed by two separate parts, with a first part comprising the first hood CP1 and a second part comprising the second hood, the flexible intermediate hood CPI being an extension of either the first hood or the second cover CP2, by a first edge of the intermediate cover, the opposite edge being free.

[0147] According to another embodiment (not illustrated) the hood system, comprising the first hood, the second hood and the flexible intermediate hood CPI forms a single-piece hood system, namely that the flexible intermediate hood is secured by a first edge to the first hood CP1, and is secured by a second edge to the second hood CP2. The flexible intermediate hood may be made of elastomer and in particular have folds forming accordion-like bellows over at least a portion of the length.

[0148] According to one embodiment, the blood loss device comprises the two fixing arms 53, 54 of the first fixing means 5 and the two fixing arms 63, 64 of the second fixing means 6, and then: - the first cover CP1 comprises coupling parts FC1, for example downwardly projecting tabs as illustrated in figures 15 and 16, configured to cooperate in a removable manner, by elastic interlocking, with parts of complementary shape of the two arms 53, 54 of the first fixing means 5, - the second cover CP2 comprises coupling parts FC2, for example downwardly projecting tabs, configured to cooperate in a removable manner, by elastic interlocking, with parts of complementary shape of the two arms 63, 64 of the second fixing means 6.

[0149] The coupling parts FC1 of the covers CP1 and CP2 may for example have male reliefs, typically arranged in pairs, configured to cooperate by elastic interlocking with female reliefs on the external sides of the arms 53, 34 or 63, 64. The two coupling parts of the same pair extend as an extension respectively of the two vertical wings of the inverted U-shaped section.

[0150] The fixing of the first cover CP1 on the two arms 53, 54 is then carried out by elastically separating the coupling parts FC1 of the same pair, by an elastic deformation tending to open the U-shaped section of the cover CP1, until the male parts are placed opposite the female parts on the outside of the arms 53, 34, causing the male and female parts to hook together under the elastic constraint of the hood, which tends to elastically bring together the two parts of the FC1 coupling part of the pair.

[0151] Similarly, the fixing of the first cover CP2 on the two arms 63, 64 is then carried out by elastically separating the coupling parts FC2 of the same pair, by an elastic deformation tending to open the U-shaped section of the cover CP2, until the male parts are placed opposite the female parts on the outside of the arms 63, 64, causing the male and female parts to hook together, under the elastic stress of the cover, which tends to elastically bring the two coupling parts FC2 of the pair together.

[0152] Such fixing is easy, requiring no removable fixing device which could create a risk of loss. Nomenclature

[0153] 1. Blood loss detection device, 2. Frame, 20. Background, 21, 22. Raised edges, 3. Flexible band, 31, 32. Longitudinal edges of the flexible strip, BR. Beads P31, P32. Respectively first longitudinal portion and second longitudinal portion of the flexible strip, 4. Electrical circuit, 5. First means of fixing, 51, 52. Hanging grooves (5 First means of fixing), 53, 54. Fixing arm (5 First means of fixing), 55,56. Support arm, 57. Flexible material bridge, 58. Indexing plot, PL1 .Foreground (5 First means of fixing), 6. Second means of fixing, 61, 62. Hanging grooves (6 Second means of fixing), 63, 64. Fixing arm (6 Second means of fixing), 65,66. Support arm, 67. Flexible material bridge, PL2. Second plan (6 Second means of fixing), 7. Means of articulation, 70. First pivot connection (fixing arm 53,54), 71. Second pivot link (fixing arm 63,64), 72. Pivot link (Support arm 55,56), 73 Pivot link (Support arm 65,66), S. Saillie, P1. First position, notably flat, P2. Second bent position, O. Openings (of the fixing arms for the straps), TE. Power on, BP. Button, MN. Cleaning mode, MT. Test mode, MD. Detection mode, DS. Blood detection step, DC. Fault detection stage (detection module), AL. Blood loss detection alarm, Ap. Op. Pivot axis and opening (first and second pivot link), Sr. Er. Radial protrusion and radial notch, Oi. Adjustment openings (indexing means)

Claims

Claims

1. A blood loss detection device suitable for detecting blood loss during hemodialysis, comprising: - a frame (2) comprising a base (20) and two raised edges (21, 22), extending in parallel in a longitudinal direction, - a flexible band (3), permeable to blood, comprising two longitudinal edges (31.32), secured to the two raised edges respectively by fixing means, configured to support an upper limb of a user, keeping it at a distance and above the bottom (20) of the frame (2), - a blood loss detection module, comprising an electrical circuit (4), arranged between the bottom (20) of the frame and the flexible strip (3), at a distance from the flexible strip (3), the electrical circuit (4) configured to detect blood loss when the blood loss passes through the flexible strip (3), permeable to blood, and is transferred by gravity onto the tracks of the electrical circuit (4), characterized in that the fixing means comprise: - a first fixing means (5), configured to hold the longitudinal edges (31.32) of the flexible strip (3) on a first longitudinal portion (P31) of the flexible strip; -- a second fixing means (6), configured to hold the longitudinal edges of the flexible strip on a second longitudinal portion (P32) of the flexible strip, -- articulation means (7) between the first fixing means (5) and the second fixing means (6), configured to pass the flexible strip (3) from a first position (P1) to a second stable folded position (P2), and in which the longitudinal edges (31, 32) of the first longitudinal portion (P31) of the flexible strip are contained in a first plane (PL1), and the longitudinal edges (31, 32) of the second longitudinal portion (P32) of the flexible strip are contained in a second plane (PL2), the first plane (PL1) and the second plane (PL2) inclined relative to each other by an angle of inclination a which is greater in the second folded position (P2) than the angle of inclination a which is possibly zero in the first position (P1).

2. A blood loss detection device according to claim 1, wherein in the first stable position (P1) is a planar position for which the longitudinal edges of the first longitudinal portion (P31) of the flexible strip and the longitudinal edges of the second longitudinal portion (P32) of the flexible strip are coplanar.

3. A blood loss detection device according to claim 1 or 2, wherein the angle a in the second folded position (P2) is between 10° and 90°, for example between 30° and 60°, for example 45°.

4. Blood loss detection device according to one of claims 1 to 3, in which the fixing means comprise two hooking grooves (51, 52) of the first fixing means (5) and two hooking grooves (61, 62) of the second fixing means (6), and in which the two longitudinal edges (31, 32) of the flexible strip (3) respectively comprise two beads (BR), of a dimension greater than the groove entrance, the hooking grooves (51, 52; 61, 62) and the beads (BR) being configured to allow the flexible strip (3) to be put in place, by threading the beads (BR) into the hooking grooves (51, 52), of the first fixing means (5) and the hooking grooves (61, 62) of the second fixing means (6), from two mouths at the ends longitudinal of the hanging grooves.

5. Blood loss detection device according to one of claims 1 to 4, wherein the first fixing means (5) comprises two fixing arms (53, 54) articulated respectively to the raised edges (21, 22) of the frame via a first pivot connection (70) of the articulation means (7), fixing arms (53, 54) along which the longitudinal edges of the first portion (P31) of flexible strip are fixed, the arms (53, 54) being able to pass from a stable retracted position, folded against the raised edges (21, 22) of the frame in the first flat position (P1) to a deployed position where the fixing arms (53, 54) are inclined relative to the raised edges of the frame in the second position (P2), folded, stable, and / or the second fixing means (6) comprises two fixing arms (63, 64) respectively, articulated to the raised edges (21, 22) of the frame via a second pivot connection (71) of the articulation means (7), fixing arms (63, 34) along which the longitudinal edges of the second portion (P32) of flexible strip are fixed, the arms (63, 44) being able to pass from a stable retracted position folded against the raised edges (21, 22) of the frame in the first flat position (P1) to a deployed position, where the fixing arms (63, 64) are inclined relative to the raised edges of the frame in the second position (P2), folded, stable.

6. A blood loss detection device according to claim 5, wherein the first fixing means (5) comprises, in addition to the two fixing arms (53, 54) articulated along the first pivot connection (70), two support arms (55, 56) articulated along a pivot axis (72) distinct from the axis of the first pivot connection (70), the support arms (55, 56) being configured to move from a retracted position, the support arms (55, 56) then interposed between the fixing arms (53, 54) then in a stable retracted position and the raised edges (21, 22) to a deployed position in which the support arms (54, 56) are raised configured to support the fixing arms (53, 54) in their deployed position, and / or the second fixing means (6) comprises, in addition to the two fixing arms (63, 64) articulated along the second pivot connection (71), two support arms (65,66) articulated along a pivot axis (73) distinct from the axis of the second pivot connection (71), the support arms (65,66) being configured to move from a retracted position, interposed between the fixing arms (63,64) then in a stable retracted position and the raised edges (21,22) to a deployed position in which the support arms (65,66) are raised configured to support the fixing arms (63,64) in their deployed position.,

7. Device according to claim 5, in which the two fixing arms (53, 54) of the first fixing means (5) are articulated respectively to the raised edges (21, 22) of the frame (2) via the first pivot connection (70) at the proximal ends (EP) of the arms, the two arms being adjoining each other. to the other via a bridge of flexible material (57) extending transversely to the arms, in particular of curved profile, at the distal ends (ED) of the arms, the assembly comprising the two arms (53,54) and the bridge of flexible material (57) forming an elastically deformable element, and in which the first pivot connection (70) of the articulation means (7) comprises indexing means allowing locking according to different inclinations of the arms (53,54) around the first pivot connection (70), the indexing means comprising at least one indexing stud (58) secured to at least one of the arms (53,54) or even two studs (58) respectively secured to the two arms (53,54), and several adjustment openings (Oi), distributed angularly around the first pivot connection (70) on the frame (2), the indexing stud (58) being configured to be inserted selectively into one of the openings of setting (Oi),and wherein the indexing means are configured to allow a change in the inclination of the arms (53,54) around the first pivot axis (70) by separating the arms (53,54) from the deformable element so as to allow the indexing stud or each indexing stud (58) to escape the adjustment opening (Oi), then by pivoting said deformable element around the first pivot connection (70) so as to change the inclination until the indexing stud becomes locked in another of the adjustment openings under the elastic force of the deformable element, and / or the two fixing arms (63,64) of the second fixing means (6) are articulated respectively to the raised edges (21,22) of the frame (2) via the second pivot connection (71) at the proximal ends (EP) of the arms, the two arms being adjoining each other via a bridge of flexible material (67) extending transversely to the arms, in particular of curved profile,at the distal ends (ED) of the arms, the assembly comprising the two arms (63,64) and the bridge of flexible material (67) forming an elastically deformable element, and in which the second pivot connection (71) of the articulation means (7) comprises indexing means allowing locking according to different inclinations of the arms (63,64) around the first pivot connection (71), the indexing means comprising at least one indexing stud secured to at least one of the arms (63,64), or two indexing studs respectively secured to the two arms (63,64), and several adjustment openings (Oi), distributed angularly around the second pivot connection (71) on the frame (2), the indexing stud being configured to be inserted selectively into one of the adjustment openings (Oi), and in which the indexing means are configured to allow a change in inclination of the arms (63,64) around the second pivot axis (71) by separating the arms (63,64) from the deformable element so as to allow the indexing stud or each indexing stud (58) to escape the adjustment opening (Oi), then by pivoting said deformable element around the first pivot connection (70) so as to change the inclination until the indexing stud comes to lock in another of the adjustment openings under the elastic force of the deformable element.

8. Device according to claim 7, wherein the first pivot connection (70) of the first holding means (5) comprises two pivot axes (Ap) projecting from the arms (53, 54), one towards the other, configured to be inserted into two openings (Op) of the frame, respectively arranged on the two raised edges, or vice versa, and wherein said deformable element is configured to be assembled to the frame (2) by insertion of the two pivot axes (Ap) which have radial projections configured to be inserted respectively through the two openings (Op) of the first pivot connection (70) when the radial projections (Sr) are aligned with radial notches (Er) of the openings (Op) in a determined angular position of the deformable element relative to the frame (2),the pivot axes prevented from coming out of the openings (Op) by pivoting the deformable element when the radial projections (Sr) of the pivot axes (Ap) are offset from the radial notches (Er) and constitute stops blocking the extraction of the pivot axes from the openings (Op) of the frame, and / or the second pivot connection (71) of the second holding means (6) comprises two pivot axes (Ap) projecting from the arms (63,64), one towards the other, configured to be inserted into two openings (Op) of the frame, respectively arranged on the two raised edges, or vice versa, and wherein said deformable element is configured to be assembled to the frame (2) by inserting the two pivot axes (Ap) which have radial projections configured to be inserted respectively through the two openings (Op) of the second pivot connection (71) when the radial projections (Sr) are aligned with radial notches (Er) of the openings (Op) in a determined angular position of the deformable element relative to the frame (2), the pivot axes prevented from coming out of the openings (Op) by pivoting of the deformable element when the radial projections (Sr) of the pivot axes (Ap) are offset from the radial notches (Er) and constitute stops blocking the extraction of the pivot axes from the openings (Op) of the frame.

9. Device according to one of claims 1 to 8, in which the bottom (20) and the raised edges (21, 22) of the gutter form a sealed gutter, and in which the electrical circuit (4) of the detection module is flexible, pressed against the bottom (20) and the raised edges (21, 22) of the frame.

10. Device according to one of claims 1 to 9, in which the tracks of the electrical circuit comprise: - a first portion of circuit forming a first comb (Pg1) and, - a second circuit portion forming a second comb (Pg2) and in which the teeth of the first comb (Pg1) and the teeth of the second comb (Pg2) are intertwined and in which the detection module is configured to ensure the detection of blood loss when the blood in contact with the tracks ensures a short circuit between the teeth of the first and second comb, or when the blood above the tracks, possibly covered with an electrical insulator, modifies the capacitance of the circuit.

11. Device according to one of claims 1 to 10, comprising a removable cover system, comprising: - a first cover (CP1) configured to be removably attached to the first attachment means (5) configured to cover the first longitudinal portion (P31) of the flexible strip, as well as a first portion of the member supported by said first longitudinal portion (P31), - a second cover (CP2) configured to be removably attached to the second attachment means (6) configured to cover the second longitudinal portion (P32) of the flexible strip, as well as a second portion of the member supported by said second longitudinal portion (P32) and in which said first cover (CP1) and said second cover (CP2) are configured to move relative to each other according to the movement permitted by the articulation means (7) between the first attachment means (5) and the second attachment means (6), when the flexible strip (3) has passed from the first position (P1) to the second stable folded position (P2).

12. Device according to claim 11 in which the first cover (CP1) has an inverted U-shaped section, along a plane perpendicular to a longitudinal direction of the first longitudinal portion (P31) and the second cover (CP2) has an inverted U-shaped section along a plane perpendicular to a longitudinal direction of the second longitudinal portion (P32).

13. Device according to claim 11 or 12, in which the hood system comprises an intermediate hood portion (CPI) extending from the first hood (CP1) and / or the second hood (CP2) providing coverage between the first hood (CP1) and the second hood (CP2) in particular at the elbow of the upper limb.

14. Device according to claim 13, in which the intermediate cover (CPI) is flexible, configured to deform when the flexible strip (3) has passed from the first position (P1) to the second stable folded position (P2).

15. Device according to claim 13 or 14 in which the hood system, including the first hood, the second hood and the intermediate hood (CPI) are formed by two separate parts, with a first part comprising the first hood (CP1) and a second part comprising the second hood, the flexible intermediate hood (CPI) being an extension of either the first hood or the second hood (CP2).

16. Device according to claim 14, wherein the hood system, comprising the first hood, the second hood and the flexible intermediate hood, (CPI) is formed by a single-piece component.

17. Device according to one of claims 5 to 8 comprising the two fixing arms (53, 54) of the first fixing means (5) and the two fixing arms (63, 64) of the second fixing means (6), in combination with one of claims 11 to 16, having the cover system comprising the first cover (CP1) and the second cover (CP2) and in which: - the first cover (CP1) comprises coupling parts (FC1), for example downwardly projecting tabs, configured to cooperate in a removable manner, by elastic interlocking, with parts of complementary shape of the two arms (53, 54) of the first fixing means (5), - the second cover (CP2) comprises coupling parts (FC2), for example downwardly projecting tabs, configured to cooperate in a removable manner, by elastic interlocking, with parts of complementary shape of the two arms (63, 64) of the first fixing means (6).

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