Subcutaneous implant and method of mounting such a subcutaneous implant.

Abstract

Title of the invention: Subcutaneous implant and method for mounting such a subcutaneous implant. The present invention relates to a subcutaneous implant (2) comprising a housing (4) including 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 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, including 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 contribute to the electrical isolation of at least some of the electronic components from the housing (4). (Figure 1)

Description

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

[0001] The present invention relates to the field of implantable medical devices. More particularly, the present invention relates to a subcutaneous implant intended to collect information to prevent the occurrence of an episode of decompensated heart failure.

[0002] Episodes of decompensated heart failure are often accompanied by emergency hospitalization of patients suffering from this cardiac condition. Indeed, episodes of decompensated heart failure often appear asymptomatic in their early stages and are not detected early enough. As the episode of decompensated heart failure progresses, the patient begins to experience the first symptoms, such as fatigue or shortness of breath. With the onset of these symptoms, the patient has a high probability of requiring emergency hospitalization to stabilize their condition.

[0003] Decompensation of heart failure can be detected before the onset of symptoms through a thorough analysis of various subclinical cardiac parameters, and more specifically hemodynamic parameters. Such detection of decompensation of heart failure in the patient allows for 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 patient's cardiac or respiratory function using subcutaneous implants. However, the architecture of prior art subcutaneous implants does not allow for optimal collection and communication of said information in combination with a compact subcutaneous implant.

[0005] The present invention falls within this context and aims 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 including 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 is housed an electrical energy storage means, 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 with respect to the first zone and / or with respect to the third zone and to participate in the electrical isolation of at least some of the electronic components from the housing.

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

[0007] The subcutaneous implant comprises three zones arranged side by side. The support is an element housed in the second zone of the subcutaneous implant, which allows the printed circuit board to be held and correctly positioned, particularly in relation to the first and / or third zones. Indeed, the first zone includes measurement and / or communication equipment intended to be electrically connected to the printed circuit board, so that the positioning of the printed circuit board relative to this first zone allows all the equipment in the first zone to be pre-assembled and connected 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 casing. This proximity necessitates isolating these electronic components from the casing. The support performs this function by incorporating walls and / or ribs, in particular, which are interposed between the electronic components and the casing wall, thus eliminating the need for a specific element to perform this function. It is understood that the support performs multiple functions, thereby limiting the number of components in the subcutaneous implant and increasing its compactness.

[0010] According to one feature of the invention, the support is formed of a semi-crystalline thermoplastic material. The support may be formed of polyetheretherketone, better known by the English designation "PEEK" for PolyEtherEtherKetone.

[0011] According to one feature of the invention, the second zone comprises an adhesive means that embeds at least some of the electronic components. This adhesive means extends partially into the second zone. More precisely, it extends from the junction between the first and second zones towards the third zone. This adhesive means makes it possible, in particular, to secure the accelerometer to the subcutaneous implant housing in such a way that the movements of the subcutaneous implant are directly captured by the accelerometer, thereby improving the quality of the information collected by the accelerometer. The adhesive means is a non-conductive adhesive that isolates the components from one another. Furthermore, the adhesive means prevents the components from moving within the subcutaneous implant, thus limiting the risk of short circuits. In addition, the adhesive means keeps the printed circuit board securely attached to the substrate.For this purpose, the bonding agent may consist of a silicone or a fully polymerized resin.

[0012] According to one feature of the invention, the support includes laterally guide edges configured to hold the printed circuit board. These guide edges hold the printed circuit board in such a way that, when the printed circuit board is housed in the support, its movements relative to the support are restricted. It is understood that by limiting the movements of the printed circuit board within the support, the positioning of the printed circuit board relative to the first and / or third zone is improved, and the position of the accelerometer embedded on the printed circuit board is more reliable.

[0013] According to one feature 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.

[0014] According to one feature of the invention, the measurement and / or communication equipment includes connection pins extending at least partially into the second zone, the printed circuit board comprising notches for receiving said connection pins. It is understood that the support is configured to allow the insertion of said connection pins of the measurement and communication equipment into the notches of the printed circuit board.

[0015] According to one feature of the invention, the first zone and the second zone are separated from each other by a compartmentalizing wall, the compartmentalizing wall being electrically connected to the housing and comprising holes for through which extend connection pins for measurement and / or communication equipment.

[0016] According to one feature of the invention, the measuring equipment includes at least one electrode and the communication equipment includes at least one communication antenna.

[0017] According to one feature of the invention, the printed circuit board comprises at least one microcontroller powered 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 feature is particularly advantageous when the converter is a buck converter in which at least some components, and in particular the inductive components, have dimensions, particularly in height along a direction perpendicular to the printed circuit board, that are larger than the other electronic components present on the printed circuit board, the bonding means ensuring the isolation of this converter from the housing.

[0018] According to one 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 adhesive. As mentioned previously, this feature allows the accelerometer to be secured to the housing in such a way that the information collected by the accelerometer is more accurate.

[0019] According to one feature of the invention, the support comprises at least one partition wall extending perpendicularly to the printed circuit board between the accelerometer and the housing, the partition wall being configured to contribute to the electrical isolation of the accelerometer from the housing. Due, in particular, to the compactness of the subcutaneous implant, the accelerometer is relatively close to the housing. Thus, the support provides electrical isolation of the accelerometer from the housing by means of the partition wall extending between the accelerometer and the housing.

[0020] According to one feature of the invention, the partition wall comprises a slot located directly above the accelerometer, the bonding means extending between the accelerometer and the housing through the slot. This slot in the partition wall allows the accelerometer to be secured to the housing by means of the bonding means.

[0021] According to one feature of the invention, the partition wall is located between 0.05 mm and 1 mm from the accelerometer. This small distance between the accelerometer and the partition wall allows, by means of bonding, to disperse by capillary action between the accelerometer and the partition wall. It is understandable that the accelerometer is more securely attached to the housing when it is also glued to the support by means of adhesive.

[0022] According to a feature of the invention, the partition wall is at a distance from the accelerometer of a distance between 0.1 mm and 0.5 mm.

[0023] According to one feature of the invention, the electrical energy storage means comprises connecting tabs extending at least partly into 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 separating element disposed between the connecting tabs and the housing, the at least one separating element being configured to participate in the electrical insulation of the connecting tabs from the housing.

[0024] The support allows the printed circuit board to be positioned relative to these connection tabs in such a way that the connection tabs are adjacent to connection areas provided for this purpose on the printed circuit board.

[0025] According to one feature of the invention, the connecting tabs have a convex shape. The convex shape of the connecting tabs increases the distance along the connecting tabs between the portion of said connecting tabs attached to the printed circuit board and the electrical energy storage means. Indeed, attaching the connecting tabs to the printed circuit board generates heat that can damage the electrical energy storage means. By increasing the heat conduction distance between the area of ​​the printed circuit board attached to the connecting tabs and the electrical energy storage means, the risk of damaging the electrical energy storage means is reduced.

[0026] It should be noted that the convex shape of the connecting tabs results in a portion of the connecting tabs being brought closer to the wall of the housing covering the printed circuit board. The support, by means of the separating element, electrically isolates the connecting tabs from the housing, and more specifically the portion of the connecting tabs closest to the housing.

[0027] According to one feature of the invention, the second zone comprises a first portion including the adhesive means and a second portion lacking the adhesive means and distinct from the first portion, the connecting tabs being provided in the second portion of the second zone. It is understood that the second portion lacks the adhesive means in order to secure the connecting tabs to the printed circuit board.

[0028] According to another feature of the invention, the second zone is completely filled by the adhesive. This filling of the second zone by the adhesive is carried out after the connecting tabs of the electrical energy storage means are attached to the printed circuit board. The filling of the second zone by the adhesive can be carried out simultaneously with the filling of the first zone by the adhesive or be carried out once the adhesive of the first zone has cured.

[0029] According to one feature of the invention, the first portion extends from the first zone and the second portion extends from the third zone.

[0030] According to one feature of the invention, the second zone comprises an opening covered by a hood, the opening being provided in the second portion. More precisely, the opening is provided opposite connection zones to which the connection tabs of the electrical energy storage means are attached to the printed circuit board.

[0031] According to one feature of the invention, the hood includes leak-testing means. These leak-testing means consist, in particular, of an orifice formed in the hood, which allows gas to be injected once the subcutaneous implant has been assembled and verifies whether gas escapes from the implant through any point other than the orifice, the orifice being blocked once the leak test has been performed. This blocking of the orifice can, for example, be achieved by laser beam.

[0032] According to one feature of the invention, the cover comprises an inner face disposed opposite the printed circuit board and an outer face opposite the inner face. A shield is attached to the inner face of the cover. The inner face includes a recess configured to create a space between the shield and the cover, opposite the leak testing means. The shield is pressed against the cover and arranged so that on one side it faces the opening and on the other side it faces at least one electronic component of the printed circuit board, the second side being opposite the first side. The cover includes a recess that creates a space between the cover and the shield when the latter is pressed against the cover. This space allows, in particular, for a leak test of the subcutaneous implant.

[0033] According to one feature of the invention, the housing is formed of three parts, each part being associated with a unique zone.

[0034] According to one feature of the invention, the electrical energy storage means is surrounded in the third zone of the housing by at least silicone and / or kapton.

[0035] The present invention also relates to a method for mounting a subcutaneous implant conforming to any one of the aforementioned characteristics, the mounting method implementing: - at least one initial 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 by pressing against the first zone, - at least a third step during which part of the second zone is embedded in the bonding medium.

[0036] During the second step the support comes to rest against a compartmentalization wall forming the junction between the first zone and the second zone.

[0037] According to one feature of the invention, during the second step the connection pins of the measurement and / or communication equipment are soldered at the slots of the printed circuit board to a track provided on the printed circuit board.

[0038] According to one feature 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.

[0039] According to one feature of the invention, the assembly method implements at least a fourth step in which the part of the housing delimiting the second zone is joined to the part of the housing delimiting the third zone.

[0040] According to one feature of the invention, the assembly method implements a fifth step in which the connection tabs of the electrical energy storage means are secured to the printed circuit board.

[0041] According to one feature of the invention, the assembly method implements at least a sixth step during which a check of the tightness of the subcutaneous implant is carried out and during which at least the second zone is filled with a neutral gas.

[0042] Other features, details and advantages of the invention will become clearer upon reading the following description on the one hand, and the illustrative and non-limiting examples of embodiments given with reference to the accompanying schematic drawings on the other hand, in which:

[0043] [Fig-1] represents a general view of a subcutaneous implant according to the present invention;

[0044] [Fig.2] represents an exploded view of the subcutaneous implant visible in [Fig.1];

[0045] [Fig.3] represents a support in which a printed circuit board is housed, the support being in contact with a first area of ​​the subcutaneous implant;

[0046] [Fig.4] represents a local cross-sectional view of the visible subcutaneous implant showing a connection tab of an electrical energy storage means attached to a connection area of ​​a printed circuit board;

[0047] [Fig.5] represents a cross-sectional view of the subcutaneous implant along a cross-sectional plane perpendicular to the cutting plane of [Fig.4], this cutting plane allows us to highlight the presence of a means of bonding in a second area of ​​the subcutaneous implant;

[0048] [Fig. 6] shows a cross-sectional view of the subcutaneous implant allowing for the placement highlighting the presence of sealing control means at the level of the second zone of the subcutaneous implant.

[0049] The features, variants, and different embodiments of the invention can be combined in various ways, provided they are not incompatible or mutually exclusive. In particular, variants of the invention may be conceived comprising only a selection of features, described hereafter in isolation from the other described features, if this selection of features is sufficient to confer a technical advantage or to differentiate the invention from the prior art.

[0050] In the figures, the elements common to several figures retain the same reference.

[0051] In the description that follows, reference will be made to an orientation as a function of the Longitudinal, Vertical and Transverse axes as arbitrarily defined by the trihedron L, V, T represented in figures 1 to 6.

[0052] Figure 1 represents a subcutaneous implant 2 according to an embodiment of the invention. This subcutaneous implant 2 is intended to be inserted 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 patient's cardiac and / or respiratory function and transmitting 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 an episode of decompensated heart failure.

[0053] As seen in [Fig. 1], the subcutaneous implant 2 comprises a titanium housing 4 including a first zone 6, a second zone 8 and a third zone 10. The second zone 8 is located 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.

[0054] The subcutaneous implant 2 extends along a main longitudinal elongation direction, i.e. parallel to the axis L. The first zone 6 extends parallel to the main longitudinal 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 main longitudinal 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.

[0055] 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.

[0056] The first electrode 16 cooperates with a second electrode, which will be described in more detail in the description that follows, to collect information relating at least to the cardiac activity of the patient, and for example to allow the recovery of electrical data enabling the preparation of an electrocardiogram.

[0057] The communication antenna 18 is here a loop antenna comprising two connection points, although this embodiment is not limiting of the invention, provided that the antenna allows the transmission of 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 disposed on the surface of this epoxy resin. To hold the first electrode 6 in the epoxy resin, the first electrode includes anchors 17, visible in more detail in [Fig. 2].

[0058] 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 along a main transverse elongation direction, i.e. parallel to the axis T, this elongation direction of the compartmentalization wall 20 being substantially perpendicular to the elongation direction of the subcutaneous implant 2.

[0059] 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 includes holes through which extend connection pins 22 of the measuring and / or communication equipment.

[0060] More specifically, in [Fig. 1], three connection pins 22 are shown. One of the connection pins 22 allows the first electrode 16 to be connected to a printed circuit board 30 housed in the part of the housing 4 delimiting the second zone 8 and visible in [Fig. 2]. Two other connection pins 22 allow the communication antenna 18 to be connected to the printed circuit board 30. understands that these 22 connection pins extend from the first zone 6 at least partly into the second zone 8.

[0061] It should be noted that these connecting pins 22 are fixed to the compartment wall 20, in particular by welding the pins to the compartment wall 20 at the level of said holes. Once the connecting pins 22 are fixed to the compartment wall 20, the holes are hermetically sealed.

[0062] The part of the housing 4 delimiting the second zone 8 includes an opening 26, visible on the [Fig.6], obstructed by a cover 28 comprising sealing control means 31 which will be described in more detail in connection with this [Fig.6].

[0063] Furthermore, the third zone 10 comprises an electrical energy storage means 32, visible in [Fig. 2]. More specifically, the portion 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 joined together so as to define an internal compartment in which the electrical energy storage means 32 is housed.

[0064] More specifically, the first half-shell 34 and the second half-shell 36 have complementary shapes and dimensions allowing the edges of one half-shell 34, 36 to be joined 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 joined together, for example by laser welding, once the electrical energy storage means 32 has been placed between the half-shells 34, 36.

[0065] The electrical energy storage means 32 is held stably, that is, in such a way as to prevent the electrical energy storage means 32 from moving within the internal housing defined by the half-shells 34, 36, by means of silicone. Furthermore, the electrical energy storage means 32 is electrically insulated from the half-shells 34, 36 by an insulating material, for example Kapton.

[0066] 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.

[0067] 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.

[0068] More specifically, the subcutaneous implant 2 comprises, in the illustrated embodiment, 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 portion devoid of parylene can be centered on the same axis parallel to the principal longitudinal elongation direction of the subcutaneous implant 2.

[0069] Figure 2 shows an exploded view of the subcutaneous implant 2 visible on the [Fig.1]. This [Fig.2] highlights the previously mentioned printed circuit board 30 and a support 38 in which the printed circuit board 30 is housed.

[0070] The printed circuit board 30 comprises a plurality of electronic components involved 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 powered by the electrical energy storage device 32, which is connected to these electronic components by connection traces, not shown here.

[0071] The converter 42 allows the microcontroller 40 to be supplied with an electrical voltage lower than the electrical voltage supplied by the electrical energy storage means 32. It is understood that the electrical voltage entering the converter 42 is greater than the electrical voltage leaving the converter 42.

[0072] Furthermore, the printed circuit board 30 includes a plurality of slots 44 for receiving the aforementioned connection pins 22. As shown in [Fig. 2], the printed circuit board 30 includes five slots 44. Three of these slots 44 are for receiving the connection pin 22 of the first electrode 16 and the two connection pins 22 of the communication antenna 18, one of which connects the communication antenna to ground and two of which are for receiving connection pins 22 for grounding at least the housing 4.

[0073] The grounded connection pins 22 are in contact with the compartment wall 20. It is understood that these grounded connection pins 22 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 isolated from the compartment wall 20.

[0074] The support 38 is configured to fit into the part of the housing 4 that defines the second zone 8. The support 38 has dimensions and a shape that complements those of the housing 4, allowing the support to fit into the rectangular tubular shape of the housing 4 that defines the second zone 8. This configuration of the support 38 prevents movement of the support 38 within the housing 4.

[0075] More specifically, the support 38 extends along a main longitudinal elongation direction and has, in a section plane perpendicular to this longitudinal direction, a U-shaped form, 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.

[0076] Furthermore, the support 38 includes laterally guide edges 46 projecting from the lateral end edges towards the interior of the support. These guide edges 46 are configured to hold the printed circuit board 30 within the support 38. More specifically, the guide edges 46 help to define a guide rail 48 at each lateral end of the support 38. These guide rails 48 allow the printed circuit board 30 to be inserted into the support 38 by sliding the printed circuit board 30 into place.

[0077] This sliding of the printed circuit board 30 in the support 38 allows, once the subcutaneous implant 2 is assembled, the printed circuit board 30 to be precisely positioned in relation to the first zone 6 and in relation to the third zone 10. This positioning of the printed circuit board 30 allows in particular the connection pins 22 to fit into the associated notches 44.

[0078] As seen in [Fig.2], the third zone 10, delimited by the half-shells 34, 36, includes the electrical energy storage means 32 comprising connection tabs 50 allowing the electrical energy storage means 32 to be electrically connected to the printed circuit board 30.

[0079] In connection with Figures 2 and 3, it is noteworthy that the printed circuit board 30 includes, on a face opposite the face on which the microcontroller 40 and the converter 42 are located, an accelerometer 52, visible in [Fig. 3]. This accelerometer 52 helps to collect information relating to cardiac and / or respiratory function.

[0080] 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.

[0081] 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.

[0082] The accelerometer 52 comprises a first face fixed to the printed circuit board and a second, opposite face, at least partially metallic, which is turned towards a wall of the housing 4. The partition wall 54 extends, as previously described, between the housing 4 and the accelerometer 52, more particularly between the housing and the second face of the accelerometer, extending to 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 previously mentioned, this partition wall 54 of the support 38, interposed between the accelerometer 52 and the housing, ensures electrical isolation of the accelerometer 52 from the housing 4.

[0083] In addition, the partition wall 54 includes a light 56, which is located at least partly 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 ​​extends into a window 58, wider than the light 56, provided opposite the opening 26 which will be described in more detail in connection with [Fig. 6].

[0084] Fig. 3 shows the arrangement of the light 56 ​​and the window 58 with respect to the printed circuit board 30 when the latter is housed in the support 38. In particular, this Fig. 3 shows that the window 58 is located opposite two connection areas 62 present on the printed circuit board 30.

[0085] The connection tabs 50 of the electrical energy storage means 32 are intended to be soldered to the connection areas 62 so that the electrical energy storage means 32 can electrically supply the various electronic components arranged on the printed circuit board 30.

[0086] The presence of the window 58 in the partition wall forms a separation element 60 provided at a longitudinal end of the proximal support 38 of 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 connecting tabs 50 and the housing 4. This separation element 60 is configured to participate in the electrical insulation of the connecting tabs 50 with respect to the housing 4.

[0087] At the level of the first zone 6, the housing 4 includes a fixing hole 64 vertically through the subcutaneous implant 2. This fixing hole 64 allows the subcutaneous implant 2 to be secured, for example by means of a wire, in an implantation site of the patient.

[0088] Figure 4 makes the separating element 60, which has just been described, and its role in electrical insulation more particularly visible. More specifically, Figure 4 shows a local cross-sectional view of the subcutaneous implant 2 along a plane of a cut extending longitudinally and vertically, that is to say parallel to the L and V axes.

[0089] As seen in [Fig.4], a connecting 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 connecting tab 50, like the other connecting tab 50, has a domed shape between the connection zone 62 and the electrical energy storage means 32.

[0090] 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 part welded to the connection zone 62. The connecting tab 50 has another portion extending between the electrical energy storage means 32 and the planar portion which has a curvature contributing to generating the domed shape of the connecting tab 50.

[0091] This domed shape of the connecting tab 50 makes it possible to increase the conduction distance of the heat generated by the weld between the connection area 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 weld.

[0092] This convex shape of the connecting tab 50 results, as seen in [Fig.4], in a close proximity between the curvature of the connecting tab 50 and the housing 4. The separating element 60 of the support 3 is disposed between the connecting tab and the housing 4, and more particularly between the curvature of the connecting 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 connecting tab 50 from the housing 4, in particular when the electrical energy storage means 32 is assembled with respect to the housing 4 and when, for this purpose, during assembly, it takes an inclined position which tends to bring the convex shape of the connecting tab 50 closer to a part of the housing.

[0093] It is noteworthy that the portion of the housing 4 delimiting the second zone 8 is joined to the portion of the housing 4 delimiting the third zone 10 at the level of joining zones 65. At the level of these joining 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.

[0094] 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 joining of 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 soldering means to achieve the joining of the connection tabs 50 to the printed circuit board 30. In the embodiment shown, this soldering of the connection tabs 50 to the printed circuit board 30 is carried out by brazing.

[0095] Figure 5 shows a feature such that, when the subcutaneous implant is assembled, the second zone 8 includes an adhesive means 66 that at least partially embeds the printed circuit board and electronic components. More specifically, the adhesive means 66 extends partially into the second zone 8, embedding only a portion of the printed circuit board. In other words, the second zone 8 comprises a first portion containing the adhesive means 66 and a second portion lacking the adhesive means 66, these two portions following each other longitudinally.

[0096] 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.

[0097] 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 partially overlapping the accelerometer 52.

[0098] The bonding means 66 is in particular an adhesive disposed in liquid form in the first portion of the second zone 8 and then solidified by polymerization, in particular by heating, to fix its position in this first portion. This pouring of the bonding means 66 is carried out in particular with the subcutaneous implant without the third zone, to allow the introduction of the adhesive 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 liquid form towards the compartmentalization wall 20, the bonding means being injected in a defined quantity to fill the entire first portion and at least partially submerge certain electronic components, and in particular the microcontroller. 40, the converter 42 and at least partly the accelerometer 52, without spilling over into the second portion of the second zone.

[0099] The bonding means 66 fills the entire first portion, both along its longitudinal dimension to extend to the second portion, and also along its 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 between the accelerometer 52 and the housing 4 through the opening 56 in the support 38, between the accelerometer 52 and the partition wall 54, and between the partition wall 54 and the housing 4.

[0100] Figure 5 shows more clearly the demarcation between the first and second portions of the second zone, with the end face of the adhesive means 66. It is noteworthy here that this end face of the adhesive means is offset longitudinally relative to the accelerometer, so that a tiny portion of the accelerometer is devoid of the adhesive means 66 and thus lies within the second portion of the second zone. This portion of the accelerometer may be devoid of the adhesive means 66 to prevent the latter from extending onto the connection areas 62 during the soldering of the connecting tabs 50 of the electrical energy storage means 32 to the printed circuit board 30.

[0101] It is noteworthy that the dimension of the space between the accelerometer 52 and the partition wall 54 allows the adhesive 66 to spread by capillary action between the partition wall 54 and the accelerometer 52. This capillary propagation, which allows the adhesive to be on 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 adhesive must spread by capillary action, the adhesive 66 spreading transversely between the partition wall 54 and the accelerometer 52 from this light in particular.

[0102] It should be noted that when the third zone 10 is brought onto the second zone 8, the connecting tabs 50 extend, like the connecting 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 adhesive means 66 to allow the connecting tabs 50 of the electrical energy storage means 32 to the connecting zone 62 to be joined.

[0103] Fig. 6 represents a cross-sectional view of the subcutaneous implant 2 along a cross-sectional plane extending vertically and transversely, i.e. parallel to the V-axis and the T-axis. This Fig. 6 makes it possible in particular to highlight the sealing control means 31 mentioned previously.

[0104] As can be seen in this [Fig. 6], the cover 28 is positioned at the opening 26 provided in the part of the housing 4 delimiting the second zone 8 and arranged opposite connection zones 62. It is understood that the opening 26 is provided 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.

[0105] The hood 28 includes an inner face 70 arranged opposite the printed circuit board 30, when the subcutaneous implant 2 is assembled, and an outer face 72 opposite the inner face 70. The hood includes an orifice 68 forming part of the sealing control means 31 and passing through the hood from the inner face 70 to the outer face 72.

[0106] The sealing control means 31 further include a shield 74 attached to the inner face 70 of the cover 28. In addition, the inner face 70 of the cover 28 includes a material clearance 76 formed around the orifice 68. This material clearance 76 is such that a space is formed between a portion of the shield 74 and the cover 28, and it is dimensioned such that the shield 74 does not completely cover the material clearance, for example, in a longitudinal direction, perpendicular to the principal elongation direction of the shield, which is visible in [Fig. 6]. Thus, fluid communication is permitted between the inside of the housing and the outside of the housing, bypassing the shield 74, via the material clearance 76 and the orifice 68 when the latter is not blocked.

[0107] More specifically, these leak-testing means 31 allow a leak test to be performed, once the implant is fully assembled, by circulating a neutral gas through the orifice 68. It is necessary to ensure that the gas does not escape through any other opening in the housing than the orifice 68. Once this leak test has been carried out, the orifice is sealed by a laser beam. The shield 74 ensures that the laser beam does not damage the electronic components located on the printed circuit board directly opposite the orifice 68.

[0108] Prior to this sealing test and the closure of the orifice by laser firing, the assembly of the subcutaneous implant 2 is carried out by following a succession of steps allowing the different zones to be joined together while allowing the first portion of the second zone to be embedded in the bonding means 66. For this purpose, according to the invention, the subcutaneous implant is assembled according to a particular assembly method.

[0109] In the description of the assembly process that follows, with reference to the various figures, each area of ​​the housing is formed of a specific part, the different parts being welded together during the process.

[0110] This assembly method involves a first step in which the printed circuit board 30 is housed in the support 38. In particular, the board of Printed circuit boards are slid inside the holder using the guide rails formed laterally in the holder.

[0111] In a second step, the support 38 comprising the printed circuit board 30 is partially housed in the part of the housing 4 forming the second zone 8, and this sub-assembly is brought against the first zone 6 and more particularly against the compartmentalization wall 20. The support 38 is said to be partially housed insofar as it is important that the notches 44 of the printed circuit board, intended to receive the various connection pins 22, protrude from the housing to allow the connection pins 22 of the measurement and communication equipment, as well as the connection pins 22 connected to ground, to be secured to the printed circuit board 30. To this end, the support 38 is pressed against the compartmentalization wall 20 so that the connection pins 22 fit into the associated notches.

[0112] 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 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.

[0113] The assembly process implements a third step, occurring after the second step and the second additional step, during which a part 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 sub-assembly formed by the first zone 6 and the second zone 8 is arranged vertically, to allow the liquid adhesive to flow by gravity towards the compartment wall, the adhesive being injected through the open side of the sub-assembly, opposite the first zone.

[0114] The adhesive is injected in an appropriate quantity to completely fill the first portion of the second zone, i.e., to completely encase the microcontroller 40 and the converter 42, and to at least partially encase the accelerometer. This third step also includes a drying time for the adhesive.

[0115] Once the first portion of the second zone 8 is embedded in the adhesive and the latter has hardened and made the accelerometer and the housing vibrationally fixed, the assembly process implements a fourth step in which the portion of the housing 4 delimiting the third zone 10 is fixed to the portion of the housing delimiting the second zone 8. The adhesive having hardened, the sub- The unit formed by the first zone 6 and the second zone 8 can be shifted into a more favorable position for the integration operation of this fourth stage. This integration between the second zone 8 and the third zone 10 is carried out in accordance with what was described previously in relation to the integration zones 65.

[0116] When the third zone 10 of the housing 4 has been joined to the second zone 8 of the housing 4, the connecting tabs 50 of the electrical energy storage means 32 are joined to the printed circuit board 30. This joining is achieved by soldering the connecting tabs 50 to the joining zones 65 through the opening 26.

[0117] In the final stages of the process, once the connecting tabs 50 are secured to the printed circuit board 30, the cover 28 is positioned to obstruct the opening 26 and the previously described sealing check is carried out.

[0118] The connection pins 22 are first secured to the printed circuit board 30 and then to the associated measurement and communication equipment. More specifically, 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.

[0119] Indeed, to perform the leak test, the subcutaneous implant 2 is placed in a chamber, and a gas, in this case a neutral gas, is injected under pressure into the chamber. The presence of the connection pins attached to the printed circuit board ensures the airtightness of the second zone at this point. 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 the leak test has been performed.

[0120] The present invention achieves its objective by proposing a subcutaneous implant whose information collection and communication are particularly efficient while optimizing the compactness of said subcutaneous implant.

Claims

Demands

1. A 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 with respect to the first zone (6) and / or with respect to the third zone (10) and to participate in the electrical isolation of at least some of the electronic components with respect to the housing (4), the second zone (8) comprising an adhesive means (66) embedding at least some of the electronic components.

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

3. 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 extend connection pins (22) of the measuring and / or communication equipment.

4. Subcutaneous implant (2) according to any one of the preceding claims, 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).

5. Subcutaneous implant (2) according to any one of the preceding claims, wherein the support (38) comprises at least one partition wall (54) extending perpendicularly 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 isolation of the accelerometer (52) from the housing (4).

6. Subcutaneous implant (2) according to any one of the preceding claims, wherein the electrical energy storage means (32) comprises connecting tabs (50) extending at least partly into 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 separating element (60) disposed between the connecting tabs (50) and the housing (4), the at least one separating element (60) being configured to participate in the electrical insulation of the connecting tabs (50) from the housing (4).

7. Subcutaneous implant (2) according to the preceding claim, wherein the second zone (8) comprises a first portion including the bonding means (66) and a second portion devoid of the bonding means (66) and distinct from the first portion, the connecting tabs (50) being provided in the second portion of the second zone (8).

8. Subcutaneous implant (2) according to the preceding claim, wherein the second zone (8) comprises an opening (26) obstructed by a hood (28), the opening (26) being provided at the level of the second portion.

9. Subcutaneous implant (2) according to the preceding claim, wherein the hood (28) includes sealing control means (31), an inner face (70) disposed opposite the printed circuit board (30) and an outer face (72) opposite the inner face (70), a shield (74) being attached to the inner face (70) of the hood (28), the inner face (70) including a material clearance (76) configured to generate a space between the shield (74) and the hood (28), opposite sealing control means (31).

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

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

12. Assembly method according to the preceding claim in combination with claim 3, wherein in the second step the connection pins (22) of the measuring and / or communication equipment are soldered at the level of notches (44) of the printed circuit board to a track provided on the printed circuit board (30).

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