Subcutaneous implant and method for mounting such a subcutaneous implant

Abstract

The present invention relates to a subcutaneous implant (2) comprising a housing (4) comprising at least a first zone (6) in which measurement and / or communication equipment is housed, a second zone (8) in which at least one printed circuit board is housed, and a third zone (10) in which an electrical energy storage means is housed, the printed circuit board comprising a plurality of electronic components, among which at least one accelerometer, the printed circuit board being housed in a support configured to position the printed circuit board at least with respect to the first zone (6) and / or with respect to the third zone (10) and to participate in the electrical insulation of at least some of the electronic components relative to the housing (4).

Description

DESCRIPTION Title of the invention: Subcutaneous implant and method of mounting such a subcutaneous implant.

[0001] The present invention relates to the field of implantable medical devices. The present invention relates more particularly to a subcutaneous implant intended to collect information making it possible to prevent the occurrence of an episode of decompensation of heart failure.

[0002] Heart failure decompensation episodes are often accompanied by emergency hospitalization for the patient suffering from this heart condition. Indeed, heart failure decompensation episodes often appear asymptomatic at the beginning and are not detected sufficiently early. The heart failure decompensation episode evolves and the patient begins to feel the first symptoms of heart failure decompensation, fatigue or even shortness of breath. With the appearance of these symptoms, the patient is highly likely to be hospitalized urgently to stabilize their condition.

[0003] Heart failure decompensations can be detected before the onset of symptoms by a thorough analysis of various subclinical cardiac parameters, and more specifically hemodynamic parameters. Such detection of heart failure decompensation in the patient allows intervention by prescribing therapeutic treatment to stabilize the patient's cardiac function without requiring hospitalization.

[0004] It is known to collect information relating to the cardiac function or the respiratory function of the patient by subcutaneous implants. However, the architecture of the subcutaneous implants of the prior art does not allow for the optimal collection of said information and communication of this information in combination with the compactness of said subcutaneous implant.

[0005] The present invention falls within this context and proposes to provide a subcutaneous implant in which the combination of these characteristics is optimized by means of a subcutaneous implant intended to be introduced under the skin of a living being, the subcutaneous implant being intended to collect information relating to the cardiac and / or respiratory activity of said living being, the subcutaneous implant comprising a housing comprising at least a first zone in which measuring and / or communication equipment is housed, a second zone in which at least one printed circuit board is housed and a third zone in which an electrical energy storage means is housed, the printed circuit board comprising a plurality of electronic components including at least one accelerometer,the printed circuit board being housed in a support configured to position the printed circuit board at least relative to the first zone and / or relative to the third zone and to participate in the electrical insulation of at least some of the electronic components relative to the housing.,

[0006] The subcutaneous implant is a device intended to be inserted under the skin of a patient in order to collect information relating to the patient's cardiac function and / or respiratory function. This information is collected by measuring equipment embedded in the subcutaneous implant, including the accelerometer. The information collected by the subcutaneous implant is transmitted to a device located outside the patient's body by communication equipment, including a communication antenna. This information allows, for example, a practitioner to define the risk of occurrence of an episode of decompensation of heart failure.

[0007] The subcutaneous implant comprises three zones arranged next to each other. The support is an element housed in the second zone of the subcutaneous implant which makes it possible to hold and correctly position the printed circuit board in particular in relation to the first zone and / or the third zone. Indeed, the first zone comprises measuring and / or communication equipment intended to be electrically connected to the printed circuit board so that the positioning of the printed circuit board printed circuits in relation to this first zone allows all the equipment in the first zone to be pre-assembled and connected together to the printed circuit board.

[0008] Like the equipment housed in the first zone, the electrical energy storage means must be connected to the printed circuit board and the support allows the printed circuit board to be positioned relative to the electrical energy storage means.

[0009] Furthermore, due to the compactness of the subcutaneous implant, the electronic components connected to the printed circuit board are close to the housing. This proximity requires isolating said electronic components from the housing. The support ensures this function by comprising walls and / or ribs in particular which are interposed between the electronic components and the wall of the housing, which makes it possible to avoid providing a specific element to perform this function. It is understood that the support ensures a plurality of functions which makes it possible to limit the number of elements in the subcutaneous implant and to increase the compactness of the latter.

[0010] In other words, the support is a mechanical part that is configured to receive the printed circuit board within it, to allow on the one hand an efficient positioning of this card and the electronic components that it carries and to allow on the other hand an electrical insulation of these components with respect to the wall of the housing surrounding said support. In this, the support of the invention can be distinguished from fixing barrels on which the printed circuit board would be positioned. In the context of the invention, the printed circuit board can be positioned, if necessary slid, in a housing provided for this purpose within the support.

[0011] According to a characteristic of the invention, the support is formed from a semi-crystalline thermoplastic material. The support may be formed from polyetheretherketone, better known by the English designation “PEEK” for PolyEtherEtherKetone.

[0012] According to a characteristic of the invention, the second zone comprises a bonding means embedding at least some of the electronic components. This bonding means extends partially in the second zone. More precisely, it extends from the junction between the first zone and the second zone towards the third zone. This bonding means makes it possible in particular to secure the accelerometer to the housing of the subcutaneous implant in such a way that the movements of the subcutaneous implant are directly taken up by the accelerometer, which improves the quality of the information collected by the accelerometer. The bonding means is a non-conductive glue that isolates the components from each other. In addition, the bonding means prevents the components from moving within the subcutaneous implant, which limits the risk of short circuits. In addition, the bonding means keeps the printed circuit board secured to the support. For this purpose, the bonding means may consist of a silicone or a fully polymerized resin.It should be noted here that the bonding means is a positioning and insulation means which complements, where appropriate, what is otherwise achieved by the support in which the printed circuit board is housed. The support is a mechanical means distinct from the bonding means. In other words, the board is held in position and protected by the support, with the bonding subsequently embedding the assembly formed by the support and the board.

[0013] According to a feature of the invention, the support laterally comprises return edges configured to hold the printed circuit board. These return edges make it possible to hold the printed circuit board in such a way that when the printed circuit board is housed in the support, the movements of the latter relative to the support are restricted. It is understood that by limiting the movements of the printed circuit board in the support, the positioning of the printed circuit board relative to the first zone and / or the third zone is improved, and the position of the accelerometer embedded on the printed circuit board is more reliable.

[0014] According to a characteristic of the invention, the return edges of the support form guide rails configured to allow the insertion of the printed circuit board into the support.

[0015] According to a characteristic of the invention, the measuring and / or communication equipment comprises connection pins extending at least partly into the second zone, the printed circuit board comprising notches intended to accommodate said connection pins. It is understood that the support is configured to allow the insertion of said connection pins of the measuring equipment and the communication equipment into the notches of the printed circuit board.

[0016] According to a characteristic of the invention, the first zone and the second zone are separated from each other by a compartmentalization wall, the compartmentalization wall being electrically connected to the housing and comprising holes through which connection pins of the measuring and / or communication equipment extend.

[0017] According to one characteristic of the invention, the measuring equipment comprises at least one electrode and the communication equipment comprises at least one communication antenna.

[0018] According to a characteristic of the invention, the printed circuit board comprises at least one microcontroller supplied with electrical energy by the electrical energy storage means, the printed circuit board comprising at least one converter configured to deliver to the microcontroller an electrical voltage lower than the electrical voltage supplied by the electrical energy storage means, the converter being embedded in the bonding means. This characteristic is particularly advantageous when the converter is a buck-type converter of which at least certain components and in particular the inductive components have dimensions, in particular in height in a direction perpendicular to the printed circuit board, greater than the other electronic components present on the printed circuit board, the bonding means making it possible to ensure the insulation of this converter with respect to the housing.

[0019] According to a feature of the invention, the accelerometer is secured and electrically connected to the printed circuit board, the accelerometer being at least partially embedded in the bonding means. As mentioned above, such a feature allows the accelerometer to be attached to the housing so that the information collected by the accelerometer is more precise.

[0020] According to a feature of the invention, the support comprises at least one partition wall extending, perpendicular to the printed circuit board, between the accelerometer and the housing, the partition wall being configured to participate in the electrical insulation of the accelerometer relative to the housing. Due, in particular, to the compactness of the subcutaneous implant, the accelerometer is relatively close to the housing. Thus, the support ensures the electrical insulation of the accelerometer relative to the housing by means of the partition wall extending between the accelerometer and the housing.

[0021] According to a feature of the invention, the partition wall comprises a light located directly above the accelerometer, the bonding means extending between the accelerometer and the housing through the light. This light in the partition wall allows the accelerometer to be made integral, by means of the bonding means, with the housing.

[0022] According to a characteristic of the invention, the partition wall is distant from the accelerometer by a distance of between 0.05 mm and 1 mm. This small distance between the accelerometer and the partition wall allows the bonding means to disperse by capillarity between the accelerometer and the partition wall. It is understood that the accelerometer is all the better secured to the housing when it is also bonded to the support by the bonding means.

[0023] According to a characteristic of the invention, the partition wall is separated from the accelerometer by a distance of between 0.1 mm and 0.5 mm.

[0024] According to a characteristic of the invention, the electrical energy storage means comprises connection tabs extending at least partly in the second zone and intended to be secured to at least one connection track of the printed circuit board, the support comprising at least one separation element arranged between the connection tabs and the housing, the at least one separation element being configured to participate in the electrical insulation of the connection tabs relative to the housing.

[0025] The holder allows the printed circuit board to be positioned relative to these connection tabs in such a way that the connection tabs adjoin connection areas provided for this purpose on the printed circuit board.

[0026] According to a feature of the invention, the connection tabs have a curved shape. The curved shape of the connection tabs makes it possible to increase the distance along the connection tabs between the portion of said connection tabs secured to the printed circuit board and the electrical energy storage means. Indeed, the securing of the connection tabs to the printed circuit board generates heat which can damage the electrical energy storage means. By increasing the heat conduction distance between the area of ​​the printed circuit board secured to the connection tabs and the electrical energy storage means, the risk of damaging the electrical energy storage means is limited.

[0027] It should be noted that the curved shape of the connection tabs leads to a bringing together of a part of the connection tabs in relation to the wall of the housing covering the printed circuit board. The support makes it possible, by means of the separating element, to electrically insulate the connection tabs in relation to the housing, and more particularly the part of the connection tabs closest to the housing.

[0028] According to a characteristic of the invention, the second zone comprises a first portion comprising the bonding means and a second portion devoid of the bonding means and distinct from the first portion, the connection tabs being provided in the second portion of the second zone. It is understood that the second portion is devoid of the bonding means in order to be able to secure the connection tabs to the printed circuit board.

[0029] According to another characteristic of the invention, the second zone is completely filled by the bonding means. This filling of the second zone by the bonding means is carried out after the connection tabs of the electrical energy storage means are secured to the printed circuit board. The filling of the second zone by the bonding means can be carried out simultaneously with the filling of the first zone. by the bonding means or be carried out once the bonding means of the first zone has crosslinked.

[0030] According to a characteristic of the invention, the first portion extends from the first zone and the second portion extends from the third zone.

[0031] According to a characteristic of the invention, the second zone comprises an opening obstructed by a cover.

[0032] According to a characteristic of the invention, the opening is provided at the level of the second portion. The opening is more precisely provided opposite connection zones on which the connection tabs of the electrical energy storage means are secured to the printed circuit board.

[0033] According to a characteristic of the invention, the cover comprises leak-proofing control means. These leak-proofing control means are formed, in particular, of an orifice originally provided in the cover, which makes it possible to inject a gas once the subcutaneous implant is assembled and to check whether gas is escaping from the implant through a location other than the orifice, the orifice being obstructed once the leak-proofing control has been carried out. This obstruction of the orifice can, for example, be carried out by a laser shot.

[0034] According to a characteristic of the invention, the cover comprises an internal face arranged opposite the printed circuit board and an external face opposite the internal face, a shield being secured to the internal face of the cover, the internal face comprising a clearance of material configured to generate a space between the shield and the cover, opposite the sealing control means. The shield is pressed against the cover and arranged so that on a first side it is opposite the orifice and on a second side it is opposite at least one electronic component of the printed circuit board, the second side being opposite the first side. The cover comprises a clearance of material making it possible to generate a space between the cover and the shield when the latter is pressed against the cover. This space makes it possible in particular to carry out a sealing test of the subcutaneous implant.

[0035] According to a characteristic of the invention, the housing is formed of three parts, each part being associated with a single zone.

[0036] According to a characteristic of the invention, the electrical energy storage means is surrounded in the third zone of the housing by at least silicone and / or kapton.

[0037] The present invention also relates to a method of mounting a subcutaneous implant conforming to any one of the aforementioned characteristics, the mounting method implementing: - at least a first step during which the printed circuit board is housed in the support, - at least a second step during which the support is housed at least partly in the second zone of the housing, coming to bear against the first zone, - at least a third step during which part of the second zone is embedded in the bonding means.

[0038] During the second stage, the support rests against a compartmentalization wall forming the junction between the first zone and the second zone.

[0039] According to a characteristic of the invention, during the second step the connection pins of the measuring and / or communication equipment are soldered at the notches of the printed circuit board to a track provided on the printed circuit board.

[0040] According to a characteristic of the invention, the assembly method implements a second additional step occurring before the third step during which the second zone is slid along the support until it comes into contact with the first zone.

[0041] According to a characteristic of the invention, the assembly method implements at least a fourth step during which the part of the housing delimiting the second zone is secured to the part of the housing delimiting the third zone.

[0042] According to a characteristic of the invention, the assembly method implements a fifth step during which the connection tabs of the electrical energy storage means are secured to the printed circuit board.

[0043] According to a characteristic of the invention, the assembly method implements at least a sixth step during which a check of the sealing of the subcutaneous implant is carried out and during which at least the second zone is filled with a neutral gas.

[0044] Other characteristics, details and advantages of the invention will emerge more clearly on reading the description which follows on the one hand, and examples of embodiment given for informational and non-limiting purposes with reference to the attached schematic drawings on the other hand, in which:

[0045] [Fig.1] represents a general view of a subcutaneous implant according to the present invention;

[0046] [Fig.2] represents an exploded view of the subcutaneous implant visible in Figure 1;

[0047] [Fig.3] represents a support in which a printed circuit board is housed, the support bearing against a first zone of the subcutaneous implant;

[0048] [Fig.4] represents a local sectional view of the visible subcutaneous implant revealing a connection tab of an electrical energy storage means secured to a connection zone of a printed circuit board;

[0049] [Fig.5] represents a sectional view of the subcutaneous implant along a sectional plane perpendicular to the sectional plane of figure 4, this sectional plane making it possible to highlight the presence of a bonding means in a second zone of the subcutaneous implant;

[0050] [Fig.6] represents a sectional view of the subcutaneous implant making it possible to highlight the presence of leak control means at the level of the second zone of the subcutaneous implant;

[0051] [Fig-7] represents a view of said sealing control means, seen from inside the subcutaneous implant which they help to form.

[0052] The features, variants and different embodiments of the invention may be combined with each other in various combinations, provided that they are not incompatible or mutually exclusive. In particular, variants of the invention may be conceived comprising only a selection of features described below in isolation from the other features described, if this selection of features is sufficient to confer a technical advantage or to differentiate the invention from the state of the art.

[0053] In the figures, elements common to several figures retain the same reference.

[0054] In the following description, we will refer to an orientation according to the Longitudinal, Vertical and Transverse axes as they are arbitrarily defined by the trihedron L, V, T represented in figures 1 to 6.

[0055] Figure 1 represents a subcutaneous implant 2 according to one embodiment of the invention. This subcutaneous implant 2 is intended to be introduced under the skin of a living being, and more specifically of a patient suffering from heart failure. The subcutaneous implant 2 is capable of collecting information relating to the cardiac and / or respiratory function of the patient and communicating it to a collection device located outside the patient. This information can then be analyzed, for example by a practitioner, to determine the risk of occurrence of an episode of decompensation of heart failure.

[0056] As seen in Figure 1, the subcutaneous implant 2 comprises a titanium housing 4 comprising a first zone 6, a second zone 8 and a third zone 10. The second zone 8 is between the first zone 6 and the third zone 10. In the embodiment shown, the housing 4 is formed of three parts distinct from each other, each of these parts being associated with a single zone 6, 8, 10 distinct from the other zones 6, 8, 10.

[0057] The subcutaneous implant 2 extends in a longitudinal main elongation direction, i.e. parallel to the axis L. The first zone 6 extends parallel to the longitudinal main elongation direction of the subcutaneous implant 2 from a first longitudinal end 12 of the subcutaneous implant 2. The third zone 10 extends parallel to the longitudinal main elongation direction of the subcutaneous implant 2 from a second longitudinal end 14, the second longitudinal end 14 being opposite the first longitudinal end 12.

[0058] In the embodiment shown, the first zone 6 of the subcutaneous implant 2 comprises measuring equipment and communication equipment. More specifically, the measuring equipment comprises at least one first electrode 16 and the communication equipment comprises at least one communication antenna 18.

[0059] The first electrode 16 cooperates with a second electrode, which will be described in more detail in the following description, to collect information relating at least to the cardiac activity of the patient, and for example to allow the recovery of electrical data allowing the development of an electrocardiogram.

[0060] The communication antenna 18 is here a loop antenna comprising two connection points, without this embodiment being limiting of the invention, since the antenna makes it possible to transmit the information collected by the measuring equipment to a collection device located outside the patient's body. It should be noted that the first electrode 16 and the communication antenna 18 are, in the embodiment shown, embedded in an epoxy resin, the first electrode being arranged on the surface of this epoxy resin. To maintain the first electrode 6 in the epoxy resin, the first electrode comprises anchors 17, visible in more detail in FIG. 2.

[0061] The first zone 6 and the second zone 8 are separated from each other by a compartmentalization wall 20 electrically connected to the housing 4. The compartmentalization wall 20 extends in a transverse main elongation direction, i.e. parallel to the axis T, this direction of elongation of the compartmentalization wall 20 being substantially perpendicular to the direction of elongation of the subcutaneous implant 2.

[0062] The compartmentalization wall 20 forms a hermetic wall between the part of the housing 4 delimiting the first zone 6 and the part of the housing 4 delimiting the second zone 8. In addition, this compartmentalization wall 20 comprises holes through which connection pins 22 of the measuring and / or communication equipment extend.

[0063] More specifically, in Figure 1, three connection pins 22 are shown. One of the connection pins 22 makes it possible to connect the first electrode 16 to a printed circuit board 30 housed in the part of the housing 4 delimiting the second zone 8 and visible in Figure 2. Two other connection pins 22 make it possible to connect the communication antenna 18 to the printed circuit board 30. It is understood that these connection pins 22 extend from the first zone 6 at least partly into the second zone 8.

[0064] It should be noted that these connection pins 22 are secured to the compartmentalization wall 20, in particular by welding the pins onto the compartmentalization wall 20 at the level of said holes. Once the connection pins 22 are secured to the compartmentalization wall 20, the holes are hermetically sealed.

[0065] The part of the housing 4 delimiting the second zone 8 comprises an opening 26, visible in figure 6, obstructed by a cover 28 comprising sealing control means 31 which will be described in more detail in connection with this figure 6.

[0066] Furthermore, the third zone 10 comprises an electrical energy storage means 32, visible in FIG. 2. More precisely, the part of the housing 4 delimiting the third zone 10 is, in the embodiment shown, formed of a first half-shell 34 and a second half-shell 36. These two half-shells 34, 36 are secured to each other so as to delimit an internal housing in which the electrical energy storage means 32 is housed.

[0067] More specifically, the first half-shell 34 and the second half-shell 36 have complementary shapes and dimensions making it possible to join the edges of one half-shell 34, 36 to the edges of the other half-shell 34, 36 to form the internal housing for the electrical energy storage means 32. The half-shells 34, 36 are secured to each other, for example by laser welding, once the electrical energy storage means 32 is placed between the half-shells 34, 36.

[0068] The electrical energy storage means 32 is held in a stable manner, that is to say in a manner to prevent the electrical energy storage means 32 from moving in the internal housing defined by the half-shells 34, 36, by means of silicone. In addition, the electrical energy storage means 32 is electrically insulated from the half-shells 34, 36 by an insulating material, for example Kapton.

[0069] It should be noted that in an alternative embodiment of the invention, the part of the housing 4 delimiting the third zone 10 can be directly formed by the electrical energy storage means 32. In other words, in this alternative embodiment, the subcutaneous implant 2 is devoid of the half-shells 34, 36 and an external envelope of the electrical energy storage means 32 directly forms the part of the housing 4 delimiting the third zone 10.

[0070] Furthermore, the part of the housing 4 delimiting the third zone 10, that is to say the part of the housing 4 formed of the half-shells 34, 36, forms the second electrode cooperating with the first electrode 16 to collect information relating at least to the cardiac activity of the patient.

[0071] More specifically, the subcutaneous implant 2 comprises, in the embodiment shown, a parylene coating surrounding the housing 4 and extending from the compartmentalization wall 20 to the second longitudinal end 14 of the subcutaneous implant 2. Only a portion of the half-shells 34, 36 is devoid of parylene, this portion then forming the second electrode. Advantageously, the portion devoid of parylene is on the same side of the subcutaneous implant 2 as the first electrode 16, being as far away as possible from said first electrode 16. Furthermore, the first electrode 16 and the part devoid of parylene can be centered on the same axis parallel to the main longitudinal elongation direction of the subcutaneous implant 2.

[0072] Figure 2 represents an exploded view of the subcutaneous implant 2 visible in Figure 1. This Figure 2 makes it possible to highlight the printed circuit board 30 previously mentioned and a support 38 in which the printed circuit board 30 is housed.

[0073] The printed circuit board 30 comprises a plurality of electronic components participating in the operation of the subcutaneous implant 2. Among these electronic components visible in FIG. 2 are a microcontroller 40 and a component of a converter 42, here an inductive element. These electronic components are supplied with electrical energy by the electrical energy storage means 32 which is connected to these electronic components by connection tracks, not shown here.

[0074] The converter 42 makes it possible to deliver to the microcontroller 40 an electrical voltage lower than the electrical voltage delivered by the electrical energy storage means 32. It is understood that the electrical voltage entering the converter 42 is higher than the electrical voltage leaving the converter 42.

[0075] Furthermore, the printed circuit board 30 comprises a plurality of notches 44 intended to accommodate the connection pins 22 previously mentioned. As visible in FIG. 2, the printed circuit board 30 comprises five notches 44. Three of these notches 44 are intended to accommodate the connection pin 22 of the first electrode 16 and the two connection pins 22 of the communication antenna 18, among which one pin makes it possible to connect the communication antenna to ground and two notches 44 are intended to accommodate connection pins 22 making it possible to connect at least the housing 4 to ground.

[0076] The connection pins 22 connected to ground are in contact with the compartmentalization wall 20. It is understood that these connection pins 22 connected to ground are electrically connected to the housing 4. It should be noted that the connection pins 22 of the first electrode 16 and of the communication antenna 18 are electrically insulated from the compartmentalization wall 20.

[0077] The support 38 is configured to be housed in the part of the housing 4 delimiting the second zone 8. The support 38 has dimensions and a shape complementary to those of the housing 4, allowing the support to be housed in the rectangular tubular shape of the housing 4 delimiting the second zone 8. Such a configuration of the support 38 makes it possible to block the movements of the support 38 within the housing 4.

[0078] More specifically, the support 38 extends in a longitudinal main elongation direction and has, in a section plane perpendicular to this longitudinal direction, a U shape, with a base formed by a partition wall 54 and branches arranged on either side of this partition wall and formed by lateral end edges 55.

[0079] In addition, the support 38 laterally comprises return edges 46 projecting from the lateral end edges towards the inside of the support. These return edges 46 are configured to hold the printed circuit board 30 within the support 38. More specifically, the return edges 46 participate in delimiting a guide rail 48 at each lateral end of the support 38. These guide rails 48 make it possible to house the printed circuit board 30 in the support 38 by sliding the printed circuit board 30.

[0080] This sliding of the printed circuit board 30 in the support 38 allows, once the subcutaneous implant 2 is assembled, to precisely position the printed circuit board 30 relative to the first zone 6 and relative to the third zone 10. This positioning of the printed circuit board 30 allows in particular the connection pins 22 to be housed in the associated notches 44.

[0081] As seen in Figure 2, the third zone 10, delimited by the half-shells 34, 36, comprises the electrical energy storage means 32 comprising connection tabs 50 making it possible to electrically connect the electrical energy storage means 32 to the printed circuit board 30.

[0082] In connection with figures 2 and 3, it is noteworthy that the printed circuit board 30 comprises, on a face opposite the face on which the microcontroller 40 and the converter 42 are arranged, an accelerometer 52, visible in figure 3. This accelerometer 52 participates in collecting information relating to the cardiac and / or respiratory function.

[0083] The support 38 is made of a plastic material, which is not electrically conductive, so that the interposition of this support between the electronic components and the titanium housing helps to ensure that no short circuit is possible.

[0084] The partition wall 54 extends, in a direction parallel to the printed circuit board 30, between the accelerometer 52 and the housing 4 when the subcutaneous implant 2 is assembled.

[0085] The accelerometer 52 comprises a first face fixed on the printed circuit board and a second opposite face, at least partly metallic, which is turned towards a wall of the housing 4. The partition wall 54 extends in accordance with what was mentioned previously between the housing 4 and the accelerometer 52, more particularly between the housing and the second face of the accelerometer, extending at a distance from the housing and the accelerometer of between 0.05 mm and 1 mm, preferably between 0.1 mm and 0.5 mm, more preferably equal to 0.2 mm. As mentioned previously, this partition wall 54 of the support 38, interposed between the accelerometer 52 and the housing, makes it possible to ensure the electrical insulation of the accelerometer 52 with respect to the housing 4.

[0086] Furthermore, the partition wall 54 comprises a light 56, which is located at least partly directly above the accelerometer 52 when the printed circuit board 30 is housed in the support 38. In the embodiment shown, this light 56 ​​extends parallel to the main longitudinal elongation direction of the support 38. The light 56 ​​is extended by a window 58, wider than the light 56, arranged opposite the opening 26 which will be described in more detail in connection with FIG. 6.

[0087] Figure 3 shows the arrangement of the light 56 ​​and the window 58 relative to the printed circuit board 30 when the latter is housed in the support 38. In particular, This figure 3 shows that the window 58 is located opposite two connection zones 62 present on the printed circuit board 30.

[0088] The connection tabs 50 of the electrical energy storage means 32 are intended to be soldered to the connection zones 62 so that the electrical energy storage means 32 can electrically supply the various electronic components arranged on the printed circuit board 30.

[0089] The presence of the window 58 in the partition wall forms a separation element 60 arranged at a longitudinal end of the support 38 proximal to the third zone 10. This separation element 60 extends transversely from one lateral edge to the opposite lateral edge of the support 38 between the connection tabs 50 and the housing 4. This separation element 60 is configured to participate in the electrical insulation of the connection tabs 50 relative to the housing 4.

[0090] At the level of the first zone 6, the housing 4 comprises a fixing hole 64 passing vertically through the subcutaneous implant 2. This fixing hole 64 makes it possible to secure, for example by means of a wire, the subcutaneous implant 2 in an implantation site of the patient.

[0091] Figure 4 makes it possible to make more particularly visible the separation element 60 which has just been described and its role in electrical insulation. More specifically, Figure 4 represents a local sectional view of the subcutaneous implant 2 along a sectional plane extending longitudinally and vertically, that is to say parallel to the axes L and V.

[0092] As seen in Figure 4, a connection tab 50 of the electrical energy storage means 32 extends partly into the second zone 8 and is connected by means of a weld to a connection zone 62. This connection tab 50, like the other connection tab 50, has a curved shape between the connection zone 62 and the electrical energy storage means 32.

[0093] More specifically, the connecting tab 50 has a portion extending in a plane parallel to the main longitudinal elongation direction of the subcutaneous implant 2, this portion of the connecting tab 50 forming the portion welded to the area of connection 62. The connection tab 50 has another part extending between the electrical energy storage means 32 and the flat part which has a curvature participating in generating the curved shape of the connection tab 50.

[0094] This curved shape of the connection tab 50 makes it possible to increase the conduction distance of the heat generated by the soldering between the connection zone 62 and the electrical energy storage means 32. Such an increase in the conduction distance makes it possible to protect the electrical energy storage means 32 from a risk of degradation by the heat emitted by the soldering.

[0095] This curved shape of the connection tab 50 results, as visible in FIG. 4, in a strong proximity between the curvature of the connection tab 50 and the housing 4. The separating element 60 of the support 3 is arranged between the connection tab and the housing 4, and more particularly between the curvature of the connection tab 50 and the housing 4. This position of the separating element 60 allows the support 38 to participate in the electrical insulation of the connection tab 50 relative to the housing 4, in particular when the electrical energy storage means 32 is assembled relative to the housing 4 and for this purpose, during assembly, it takes an inclined position which tends to bring the curved shape of the connection tab 50 closer to a part of the housing.

[0096] It is noteworthy that the part of the housing 4 delimiting the second zone 8 is secured to the part of the housing 4 delimiting the third zone 10 at the level of securing zones 65. At the level of these securing zones 65, the shape of the longitudinal edge of the second zone 8 cooperates with the shape of the longitudinal edge of the third zone 10 opposite the second zone 8. In the embodiment shown, the longitudinal edge of the second zone 8 opposite the third zone 10 has a shoulder with which the longitudinal edge of the third zone 10 cooperates.

[0097] It should be noted that the joining of the part of the housing 4 delimiting the third zone 10 with the part of the housing 4 delimiting the second zone 8, with the opening 26 in the second zone 8 which is not yet covered by the cover 28, is carried out before the securing the connection tabs 50 to the printed circuit board 30. It is understood that the opening 26 provided in the housing 4 delimiting the second zone 8 and the window 58 provided in the support 38 allow the passage of welding means to secure the connection tabs 50 to the printed circuit board 30. In the embodiment shown, this welding of the connection tabs 50 to the printed circuit board 30 is carried out by soldering.

[0098] Figure 5 shows a feature such that, when the subcutaneous implant is assembled, the second zone 8 comprises a bonding means 66 which at least partially embeds the printed circuit board and electronic components. More particularly, the bonding means 66 extends partially into the second zone 8 by embedding only a part of the printed circuit board. In other words, the second zone 8 comprises a first portion comprising the bonding means 66 and a second portion devoid of the bonding means 66, these two portions succeeding each other longitudinally.

[0099] The first portion of the second zone 8 extends from the first zone 6 towards the third zone 10 and the second portion of the second zone 8 extends from the third zone 10 towards the first zone 6. It is understood that the first and second portions of the second zone 8 extend successively in the second zone 8 in the longitudinal direction, from the first zone 6 to the third zone 10.

[0100] The arrangement of the bonding means 66 in the first portion is such that the elements present in the first portion of the second zone 8 are embedded in the bonding means 66. More precisely, the bonding means 66 extends, as shown in FIG. 5, at least partly covering the accelerometer 52.

[0101] The bonding means 66 is in particular a glue placed in the liquid state in the first portion of the second zone 8 then made solid by polymerization, in particular by heating, to fix its position in this first portion. This casting of the bonding means 66 is in particular carried out with the subcutaneous implant without the third zone, for allow the introduction of the glue on the side of the second portion of the second zone, opposite the first zone, and with this implant in a vertical position to allow the flow of the bonding means in the liquid state towards the compartmentalization wall 20, the bonding means being injected in a defined quantity to fill the whole of the first portion and at least partially drown certain electronic components, and in particular the microcontroller 40, the converter 42 and at least partly the accelerometer 52, without overflowing onto the second portion of the second zone.

[0102] The bonding means 66 fills the entire first portion, both along the longitudinal dimension to extend to the second portion, but also along the transverse and vertical dimensions so that it extends from one wall of the housing to the opposite wall. In this way, the bonding means 66 extends both between the accelerometer 52 and the housing 4 through the light 56 ​​of the support 38, between the accelerometer 52 and the partition wall 54 and between the partition wall 54 and the housing 4.

[0103] Figure 5 makes more particularly visible the demarcation between the first portion and the second portion of the second zone, with the end face of the bonding means 66. It is notable here that this end face of the bonding means is offset longitudinally relative to the accelerometer, so that a tiny part of the accelerometer is devoid of the bonding means 66 and is thus inscribed in the second portion of the second zone. This part of the accelerometer can be devoid of the bonding means 66 to prevent the latter from overflowing onto the connection zones 62 when soldering the connection tabs 50 of the electrical energy storage means 32 to the printed circuit board 30.

[0104] It is notable that the dimension of the space between the accelerometer 52 and the partition wall 54 allows the bonding means 66 to spread by capillarity between the partition wall 54 and the accelerometer 52. This propagation by capillarity, which allows glue to be applied over the entire surface of the accelerometer, is facilitated by the presence of the light 56 ​​which limits the extent of the surface along which the glue must spread by capillarity, the bonding means 66 spreading transversely between the partition wall 54 and the accelerometer 52 from this light in particular.

[0105] It should be noted that when the third zone 10 is attached to the second zone 8, the connection tabs 50 extend, like the connection zones 62, strictly in the second portion of the second zone 8. It is understood that the second portion of the second zone 8 is devoid of the bonding means 66 to allow the connection tabs 50 of the electrical energy storage means 32 to be secured to the connection zone 62.

[0106] Figure 6 represents a sectional view of the subcutaneous implant 2 along a sectional plane extending vertically and transversely, that is to say parallel to the axis V and to the axis T. This figure 6, as well as figure 7 illustrating the cover 28 in more detail, makes it possible in particular to highlight the sealing control means 31 mentioned previously.

[0107] As seen in this figure 6, the cover 28 is arranged at the level of the opening 26 provided in the part of the housing 4 delimiting the second zone 8 and arranged opposite the connection zones 62. It is understood that the opening 26 is arranged at the level of the second portion to allow the connection tabs 50 to be connected to the connection zones 62. The cover 28 is added to close the opening 26 once the connection tabs 50 have been welded to the connection zones 62.

[0108] The cover 28 comprises an internal face 70 arranged opposite the printed circuit board 30, when the subcutaneous implant 2 is assembled, and an external face 72 opposite the internal face 70. The cover comprises an orifice 68 forming part of the sealing control means 31 and passing through the cover from the internal face 70 to the external face 72.

[0109] The sealing control means 31 further comprise a shield 74 secured to the internal face 70 of the cover 28. In addition, the internal face 70 of the cover 28 comprises a clearance of material 76 formed around the orifice 68. This clearance of material 76 is such that a space is formed between a part of the shield 74 and the cover 28. and it is dimensioned such that the shield 74 does not completely cover the clearance of material, for example in a longitudinal direction here, perpendicular to the main elongation direction of the shield which is visible in Figure 6. By way of example, notably visible in Figure 7, in which the shield 74 has been made transparent and shown in dotted lines to clearly show the clearance of material 76 that the shield 74 partially covers, the clearance of material can take a circular shape and the shield 74 can take a rectangular shape, with the diameter of the clearance of material 76 which is of a value greater than the width of the shield 74 and less than the length of this shield 74.In this way, the shield 74 can be welded to the inner face 70 of the cover while leaving an area not covered by the release of material through which the control gas injected through the opening 68 can pass for the proper conduct of the leak test, prior to the closing of the opening 68, for example by laser firing. In other words, fluid communication is allowed between the inside of the housing and the outside of the housing, avoiding the shield 74, via the release of material 76 and the orifice 68 when the latter is not blocked.

[0110] More specifically, these leak testing means 31 make it possible to carry out a leak test, once the implant is completely assembled, by circulating a neutral gas through the orifice 68. It is necessary to ensure that the gas does not exit through any other opening in the housing than the orifice 68. Once this leak test has been carried out, the orifice is blocked by a laser shot. The shield 74 makes it possible to ensure that the laser shot does not damage the electronic components located on the printed circuit board directly opposite the orifice 68. It is understood that FIG. 6 partially illustrates the housing, and in a configuration where the orifice 68 has not been blocked by a laser shot, to make the existence of this orifice visible. [or i] The leak testing means are thus provided in such a way that the orifice 68 allows the introduction of gas for leak testing, the plug 74 allows the electronic components to be protected when an operation of closing this orifice is subsequently carried out by a laser shot, and the release of material 76 allows the passage of gas next to the plug 74 during the leak testing step.

[0112] Prior to this leak test and the closing of the orifice by laser firing, the assembly of the subcutaneous implant 2 is carried out by following a succession of steps making it possible to secure the different zones to each other while making it possible to embed the first portion of the second zone in the bonding means 66. To this end, according to the invention, the subcutaneous implant is assembled according to a particular assembly method.

[0113] In the following description of the assembly process, with reference to the various figures, each area of ​​the housing is formed from a specific part, the different parts being welded to each other during the process.

[0114] This mounting method implements a first step during which the printed circuit board 30 is housed in the support 38. In particular, the printed circuit board is slid inside the support using the guide rails formed laterally in the support.

[0115] In a second step, the support 38 comprising the printed circuit board 30 is housed partly in the part of the housing 4 forming the second zone 8, and this subassembly is brought against the first zone 6 and more particularly against the compartmentalization wall 20. The support 38 is said to be housed partly insofar as it is important that the notches 44 of the printed circuit board, intended to receive the different connection pins 22, protrude from the housing to allow the connection pins 22 of the measurement equipment and the communication equipment, but also the connection pins 22 connected to ground, to be secured to the printed circuit board 30. For this purpose, the support 38 is pressed against the compartmentalization wall 20 so that the connection pins 22 are housed in the associated notches.

[0116] The assembly method implements a second additional step, once the connection pins 22 are secured to the printed circuit board 30, during which the part of the housing forming the second zone 8 is slid along the support 38 until it comes into contact with the part of the housing forming the first zone 6 and more particularly into contact with the compartmentalization wall 20. The part of the housing 4 delimiting the second zone 8 is then secured to the part of the housing 4 delimiting the first zone 6, in particular by a welding operation.

[0117] The assembly method implements a third step, occurring after the second step and the second additional step, during which a portion of the second zone 8 is embedded in the bonding means 66. It is understood in accordance with what has been described previously that during this third step, the first portion of the second zone 8 is embedded in the bonding means 66. For this purpose, it is ensured that the subassembly formed by the first zone 6 and the second zone 8 is arranged vertically, to allow the glue in the liquid state to flow by gravity towards the compartmentalization wall, the glue being injected through the open side of the subassembly, opposite the first zone.

[0118] The glue is injected in an appropriate quantity to completely fill the first portion of the second zone, that is to say to drown in particular the microcontroller 40 and the converter 42 and to drown at least partially the accelerometer. This third step also includes a drying time for the bonding means.

[0119] Once the first portion of the second zone 8 is embedded in the bonding means and the latter has hardened and made the accelerometer and the housing vibrationally integral, the assembly method implements a fourth step during which the part of the housing 4 delimiting the third zone 10 is secured to the part of the housing delimiting the second zone 8. The bonding means having hardened, the subassembly formed by the first zone 6 and the second zone 8 can be tilted into another position more favorable to the securing operation of this fourth step. This securing between the second zone 8 and the third zone 10 is carried out in accordance with what has been described previously in connection with the securing zones 65.

[0120] When the third zone 10 of the housing 4 has been secured to the second zone 8 of the housing 4, the connection tabs 50 of the electrical energy storage means 32 are secured to the printed circuit board 30. This securing is carried out by a welding the connection tabs 50 to the joining zones 65 through the opening 26.

[0121] In the final steps of the method, once the connection tabs 50 have been secured to the printed circuit board 30, the cover 28 is positioned to obstruct the opening 26 and the previously described leaktightness check is carried out.

[0122] The connection pins 22 are first secured to the printed circuit board 30 and secondly secured to the associated measurement and communication equipment. More particularly, the step of securing the connection pins 22 to the printed circuit board 30 takes place before the leak test while the step of securing the connection pins 22 to the measurement and communication equipment is carried out after the leak test.

[0123] Indeed, to carry out the leak test, the subcutaneous implant 2 is placed in a box and a gas, in this case a neutral gas, is injected under pressure into the box. The presence of the connection pins secured to the printed circuit board makes it possible at this moment to ensure the hermeticity of the second zone. Since epoxy resin is not suitable for such a test, the first electrode 6 and the communication antenna 18 are embedded in the epoxy resin after carrying out the leak test.

[0124] The present invention achieves the goal it set for itself by proposing a subcutaneous implant whose collection of information and communication of this information are particularly effective while optimizing the compactness of said subcutaneous implant.

Claims

CLAIMS 1. Subcutaneous implant (2) intended to be introduced under the skin of a living being, the subcutaneous implant (2) being intended to collect information relating to the cardiac and / or respiratory activity of said living being, the subcutaneous implant (2) comprising a housing (4) comprising at least a first zone (6) in which measuring and / or communication equipment is housed, a second zone (8) in which at least one printed circuit board (30) is housed and a third zone (10) in which an electrical energy storage means (32) is housed, the printed circuit board (30) comprising a plurality of electronic components including at least one accelerometer (52),the printed circuit board (30) being housed in a support (38) configured to position the printed circuit board (30) at least relative to the first zone (6) and / or relative to the third zone (10) and to participate in the electrical insulation of at least some of the electronic components relative to the housing (4)., 2. Subcutaneous implant (2) according to the preceding claim, in which the second zone (8) comprises a bonding means (66) embedding at least some of the electronic components.

3. Subcutaneous implant (2) according to any one of the preceding claims, wherein the support (38) laterally comprises return edges (46) configured to hold the printed circuit board (30).

4. Subcutaneous implant (2) according to any one of the preceding claims, wherein the first zone (6) and the second zone (8) are separated from each other by a compartmentalization wall (20), the compartmentalization wall (20) being electrically connected to the housing (4) and comprising holes through which connection pins (22) of the measuring and / or communication equipment extend.

5. Subcutaneous implant (2) according to any one of the preceding claims in combination with claim 2, wherein the accelerometer (52) is secured and electrically connected to the printed circuit board (30), the accelerometer (52) being at least partially embedded in the bonding means (66).

6. Subcutaneous implant (2) according to any one of the preceding claims, wherein the support (38) comprises at least one partition wall (54) extending, perpendicular to the printed circuit board (30), between the accelerometer (52) and the housing (4), the partition wall (54) being configured to participate in the electrical insulation of the accelerometer (52) relative to the housing (4).

7. Subcutaneous implant (2) according to any one of the preceding claims, in which the electrical energy storage means (32) comprises connection tabs (50) extending at least partly in the second zone (8) and intended to be secured to at least one connection track of the printed circuit board (30), the support (38) comprising at least one separation element (60) arranged between the connection tabs (50) and the housing (4), the at least one separation element (60) being configured to participate in the electrical insulation of the connection tabs (50) relative to the housing (4).

8. Subcutaneous implant (2) according to the preceding claim, in combination with claim 2, in which the second zone (8) comprises a first portion comprising the bonding means (66) and a second portion devoid of the bonding means (66) and distinct from the first portion, the connection tabs (50) being provided in the second portion of the second zone (8).

9. Subcutaneous implant (2) according to one of the preceding claims, in which the second zone (8) comprises an opening (26) obstructed by a cover (28).

10. Subcutaneous implant (2) according to claims 8 and 9, wherein the opening (26) is provided at the second portion.

11. Subcutaneous implant (2) according to claim 9 or 10, wherein the cover (28) comprises sealing control means (31), an internal face (70) arranged opposite the printed circuit board (30) and an external face (72) opposite the internal face (70), a shield (74) being secured to the internal face (70) of the cover (28), the internal face (70) comprising a clearance of material (76) configured to generate a space between the shield (74) and the cover (28), opposite the sealing control means (31).

12. Subcutaneous implant (2) according to any one of the preceding claims, in which the housing (4) is formed of three parts, each part being associated with a single zone (6, 8, 10).

13. Method for mounting a subcutaneous implant (2) according to any one of the preceding claims, in combination with claim 2, the mounting method implementing: - at least a first step during which the printed circuit board (30) is housed in the support (38), - at least a second step during which the support (38) is housed at least partly in the second zone (8) of the housing (4) while coming to bear against the first zone (6), - at least a third step during which a part of the second zone (8) is embedded in the bonding means (66).

14. Mounting method according to the preceding claim in combination with claim 4, wherein during the second step the connection pins (22) of the measuring and / or communication equipment are soldered at the notches (44) of the printed circuit board to a track provided on the printed circuit board (30).

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