Subcutaneous implants and methods for assembling such subcutaneous implants

Abstract

The present invention relates to a subcutaneous implant (2) comprising a housing (4) having at least a first zone (6) housing measuring instruments and / or communication equipment, a second zone (8) housing at least one printed circuit board, and a third zone (10) housing electrical energy storage means, wherein the printed circuit board comprises a plurality of electronic components including at least one accelerometer, and the printed circuit board is housed in a support configured to position the printed circuit board relative to at least the first zone (6) and / or the third zone (10) and to participate in the electrical insulation of at least some of the electronic components from the housing (4). (Figure 1)

Description

Technical Field

[0001] The present invention relates to the field of implantable medical devices. More particularly, the present invention relates to a subcutaneous implant aimed at collecting information that enables the prevention of the onset of decompensation episodes in heart failure.

Background Art

[0002] The onset of decompensation in heart failure often involves emergency hospitalization of patients suffering from this heart disease. In fact, the onset of decompensation in heart failure often appears asymptomatic in the early stages and is not detected early enough. The onset of decompensation in heart failure progresses, and patients begin to experience initial symptoms such as decompensation in heart failure, fatigue, or shortness of breath. When these symptoms appear, the likelihood of emergency hospitalization of the patient increases to stabilize the patient's condition.

[0003] Decompensation in heart failure can be detected by thoroughly analyzing various asymptomatic cardiac parameters, more particularly hemodynamic parameters, before the symptoms appear. Such detection of decompensation in heart failure in patients enables intervention in the patients and the administration of treatment, thereby making it possible to stabilize the cardiac function of the patients and eliminating the need for hospitalization of the patients.

[0004] It is known that information regarding the cardiac function or respiratory function of a patient can be collected by a subcutaneous implant. Nevertheless, in the architecture of prior art subcutaneous implants, it is impossible to combine and relate the optimal collection of the information and the communication of this information with the compactness of the subcutaneous implant.

Summary of the Invention

Means for Solving the Problems

[0005] The present invention is suited to such circumstances and aims to provide a subcutaneous implant, the combination of which is optimized by a subcutaneous implant for introduction under the skin of a living organism and for collecting information relating to the cardiac and / or respiratory activity of the living organism, comprising a housing comprising at least one first zone housing measuring and / or communication equipment, a second zone housing at least one printed circuit board, and a third zone housing electrical energy storage means, wherein the printed circuit board comprises a plurality of electronic components including at least one accelerometer, and the printed circuit board is housed in a support configured to position the printed circuit board relative to at least the first and / or third zones and to participate in the electrical insulation of at least some of the electronic components from the housing.

[0006] Subcutaneous implants are devices designed to be placed under the patient's skin, allowing for the collection of information about the patient's cardiac and / or respiratory function. This information is collected by measuring instruments embedded within the subcutaneous implant, including accelerometers. The information collected by the subcutaneous implant is transmitted to a device located outside the patient's body, particularly by a communication device equipped with a communication antenna. For example, this information can be used by healthcare professionals to determine the risk of developing an uncompensated episode of heart failure.

[0007] The subcutaneous implant comprises three adjacent zones. The support is an element housed within the second zone of the subcutaneous implant, which holds the printed circuit board and allows for proper positioning, particularly with respect to the first and / or third zones. In fact, since the first zone contains measuring and / or communication equipment intended to be electrically connected to the printed circuit board, positioning the printed circuit board relative to the first zone allows for the pre-assembly of all the equipment in the first zone and its connection to the printed circuit board.

[0008] Similar to the equipment housed within the first zone, the electrical energy storage means is also required to 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, the compactness of the subcutaneous implant means that the electronic components connected to the printed circuit board are in close proximity to the housing. This proximity necessitates insulating the electronic components from the housing. This function is ensured by the support, particularly by the provision of walls and / or ribs interposed between the electronic components and the housing walls, thereby avoiding the need for specific elements to ensure this function. Naturally, the support ensures multiple functions, thereby limiting the number of elements in the subcutaneous implant and improving its compactness.

[0010] In other words, the support is a mechanical part configured to house a printed circuit board, thereby enabling, firstly, effective positioning of the board and the electronic components it supports, and secondly, electrical insulation of the components from the walls of the housing surrounding the support. In this respect, the support of the present invention can be distinguished from a fixed stud on which the printed circuit board is positioned. In the context of the present invention, the printed circuit board may be positioned and, if necessary, slid into a housing provided inside the support for sliding.

[0011] According to one feature of the present invention, the support is formed from a semi-crystalline thermoplastic material. The support may be formed from polyetheretherketone, which is better known by the English name "PEEK" for polyetheretherketone.

[0012] According to one feature of the present invention, the second zone comprises adhesive means for embedding at least some of the electronic components. This adhesive means partially extends within the second zone. More specifically, the adhesive means extends from the junction between the first and second zones toward the third zone. In particular, the adhesive means makes it possible to fix the accelerometer to the housing of the subcutaneous implant, thereby allowing the movement of the subcutaneous implant to be directly detected by the accelerometer, thereby improving the quality of the information collected by the accelerometer. The adhesive means is a non-conductive adhesive that enables the components to be insulated from one another. Furthermore, the adhesive means makes it possible to prevent the movement of components within the subcutaneous implant, thereby limiting the risk of short circuits. Furthermore, the adhesive means makes it possible to fix and hold the printed circuit board to the support. For this purpose, the adhesive means may consist of silicone or a fully polymerized resin. It should be noted that the adhesive means is a supplementary positioning and insulating means, which, if necessary, is further achieved by the support housing the printed circuit board. This support is a mechanical means separate from the adhesive means. In other words, the plate is held in position and protected by the support, and in the second step, the assembly formed by the support and the plate is embedded by adhesive.

[0013] According to one feature of the present invention, the support comprises laterally configured support edges for holding a printed circuit board. These support edges make it possible to hold the printed circuit board such that its movement relative to the support is restricted when the printed circuit board is housed within the support. Naturally, restricting the movement of the printed circuit board within the support improves the positioning of the printed circuit board relative to the first and / or third zones, and makes the positioning of the embedded accelerometer relative to the printed circuit board more reliable.

[0014] According to one feature of the present invention, the support edge of the support is configured to form a guide rail that allows a printed circuit board to be inserted into the support.

[0015] According to one feature of the present invention, the measuring instrument and / or communication device comprises a connecting pin that extends at least partially within a second zone, and the printed circuit board comprises a notch intended to accommodate the connecting pin. Naturally, the support is configured to allow the insertion of the connecting pin of the measuring instrument and communication device into the notch of the printed circuit board.

[0016] According to one feature of the present invention, the first zone and the second zone are separated from each other by a partition wall, which is electrically connected to the housing and has holes through which connection pins for measuring instruments and / or communication instruments pass.

[0017] According to one feature of the present invention, the measuring instrument comprises at least one electrode, and the communication instrument comprises at least one communication antenna.

[0018] According to one feature of the present invention, the printed circuit board comprises at least one microcontroller supplied with electrical energy by an electrical energy storage means, and the printed circuit board comprises at least one transducer configured to supply a voltage lower than the voltage supplied by the electrical energy storage means to the microcontroller, the transducer being embedded within an adhesive means. This feature is particularly advantageous if the transducer is a step-down type transducer, and some components of the transducer, in particular the inductive components, are larger in dimensions than other electronic components present on the printed circuit board, especially in height in a direction perpendicular to the printed circuit board, and the adhesive means can ensure the transducer is insulated from the housing.

[0019] According to the features of the present invention, the accelerometer is fixed to and electrically connected to a printed circuit board and at least partially embedded within an adhesive means. As described above, these features make it possible to fix the accelerometer to the housing, thereby making the information collected by the accelerometer more accurate.

[0020] According to one feature of the present 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 provide electrical insulation of the accelerometer from the housing. In particular, due to the compactness of the subcutaneous implant, the accelerometer is relatively close to the housing. Therefore, the support ensures electrical insulation of the accelerometer from the housing by the partition wall extending between the accelerometer and the housing.

[0021] According to one feature of the present invention, the partition wall has a gap that is aligned vertically with the accelerometer, and the adhesive means extends through the gap between the accelerometer and the housing. The gap provided in the partition wall makes it possible to fix the accelerometer to the housing via the adhesive means.

[0022] According to one feature of the present invention, the partition wall is set back from the accelerometer by a distance between 0.05 mm and 1 mm. This short distance between the accelerometer and the partition wall allows the adhesive means to spread between the accelerometer and the partition wall by capillary action. Naturally, the accelerometer is more securely fixed to the housing when it is also bonded to the support by the adhesive means.

[0023] According to one feature of the present invention, the partition wall is located at a distance from the accelerometer that falls within the range of 0.1 mm to 0.5 mm.

[0024] According to one feature of the invention, the electrical energy storage means comprises connection tabs which extend at least partially within the second zone and are intended to be fixed to at least one connection conductor path of the printed circuit board, the support comprises at least one separation element arranged between the connection tabs and the housing, and this at least one separation element is configured to participate in the electrical insulation of the connection tabs with respect to the housing.

[0025] The support makes it possible to position the printed circuit board relative to the connection tabs such that the connection tabs are adjacent to a connection zone provided on the printed circuit board for the purpose of adjacency.

[0026] According to one feature of the invention, the connection tabs have a bent shape. The bent shape of the connection tabs makes it possible to increase the distance along the connection tabs between the part of the connection tabs fixed to the printed circuit board and the electrical energy storage means. In fact, fixing the connection tabs to the printed circuit board generates heat which may damage the electrical energy storage means. By increasing the thermal conduction distance between the zone of the printed circuit board to which the connection tabs are fixed and the electrical energy storage means, the risk of damaging the electrical energy storage means is limited.

[0027] It should be noted that as a result of the bent shape of the connection tabs, a part of the connection tabs is brought closer to the wall of the housing covering the printed circuit board. The support enables the separation element to electrically insulate the connection tabs, more particularly the part of the connection tabs closest to the housing, with respect to the housing.

[0028] According to one feature of the invention, the second zone comprises a first part provided with adhering means and a second part separate from the first part and not provided with adhering means, and the connection tabs are formed within the second part of the second zone. Of course, this second part is not provided with adhering means so that the connection tabs can be fixed to the printed circuit board.

[0029] According to another feature of the present invention, the second zone is completely filled with an adhesive means. Filling the second zone with the adhesive means is performed after fixing the connection tab of the electrical energy storage means to the printed circuit board. Filling the second zone with the adhesive means may be performed in parallel with filling the first zone with the adhesive means, or may be performed after the adhesive means of the first zone is crosslinked.

[0030] According to one feature of the present invention, the first part extends from the first zone, and the second part extends from the third zone.

[0031] According to one feature of the present invention, the second zone comprises an opening closed by a cap.

[0032] According to one feature of the present invention, the opening is formed in the second part. More specifically, the opening is formed facing a connection zone for fixing the connection tab of the electrical energy storage means to the printed circuit board.

[0033] According to one feature of the present invention, the cap comprises sealing control means. In particular, this sealing control means is formed by an orifice originally formed in the cap, and by this orifice, after the subcutaneous implant is assembled, it is possible to inject gas and verify whether the gas is flowing out of the implant at a position other than the orifice. After the sealing control is completed, the orifice is closed. For example, this closing of the orifice may be performed by a laser shot.

[0034] According to one feature of the present invention, the cap comprises an inner surface positioned facing a printed circuit board and an outer surface opposite to this inner surface, the shield being fixed to the inner surface of the cap, the inner surface comprising a material recess configured to form a space between the shield and the cap facing a sealing control means. The shield is pressed against the cap and positioned such that it faces an orifice on a first side and faces at least one electronic component of the printed circuit board on a second side, the second side being opposite to the first side. The cap comprises a material recess that allows a space to be formed between the cap and the shield when the shield is pressed against the cap. In particular, this space makes it possible to perform sealing tests on a subcutaneous implant.

[0035] According to one feature of the present invention, the housing is formed by three parts, each assigned to a single zone.

[0036] According to one feature of the present invention, the electrical energy storage means is surrounded by at least silicone and / or Kapton within a third zone of the housing.

[0037] The present invention also provides a method for assembling a subcutaneous implant according to any one of the features described above, - At least one first step of housing a printed circuit board within a support, - At least one second step of housing the support in the first zone, at least partially within the second zone of the housing, - At least one third step of embedding a portion of the second zone within the adhesive means This also concerns the methods used to implement it.

[0038] During the second step, the support is supported by a partition wall that forms a junction between the first zone and the second zone.

[0039] According to one feature of the present invention, in a second step, the connection pins of the measuring instrument and / or communication instrument are soldered to the conductive path formed in the printed circuit board at the notch of the printed circuit board.

[0040] According to one feature of the present invention, the assembly method includes an additional second step, which is performed prior to the third step, in which the second zone is slid along the support to bring it into contact with the first zone.

[0041] According to one feature of the present invention, the assembly method includes performing at least one fourth step of fixing the portion of the housing defining the second zone to the portion of the housing defining the third zone.

[0042] According to one feature of the present invention, the assembly method involves a fifth step of fixing the connection tabs of the electrical energy storage means to the printed circuit board.

[0043] According to one feature of the present invention, the assembly method includes controlling the sealing of the subcutaneous implant and performing at least one sixth step of filling at least a second zone with neutral gas.

[0044] Further features, details, and advantages of the present invention will become clearer, on the one hand, by reviewing the following description, and on the other hand, by referring to the embodiments described for illustrative and non-limiting purposes with reference to the accompanying schematic drawings. [Brief explanation of the drawing]

[0045] [Figure 1] This is an overall diagram of the subcutaneous implant according to the present invention. [Figure 2] Figure 1 is an exploded view of a subcutaneous implant. [Figure 3] This figure shows a support structure that holds the first zone of a subcutaneous implant, which houses a printed circuit board. [Figure 4]This is a visible local cross-sectional view of a subcutaneous implant revealing the connection tabs of an electrical energy storage device fixed to the connection zone of a printed circuit board. [Figure 5] This is a cross-sectional view of a subcutaneous implant, taken from a cross-sectional plane perpendicular to the cross-sectional plane of Figure 4, revealing the presence of adhesive means in the second zone of the subcutaneous implant. [Figure 6] This is a cross-sectional view of a subcutaneous implant that makes it possible to reveal the presence of sealing control means in the second zone of the subcutaneous implant. [Figure 7] This figure shows the sealing control means involved in the formation of the subcutaneous implant, as viewed from the inside. [Modes for carrying out the invention]

[0046] The features, variations, and different embodiments of the present invention may be related to each other in various combinations, provided that they are not contradictory or mutually exclusive. In particular, it is possible to envision variations of the present invention in which some of the features described below are selected from other features, provided that such selections of features provide a technical advantage or are sufficient to distinguish the present invention from the prior art.

[0047] In the diagrams, elements common to multiple drawings are given the same reference numerals.

[0048] In the following description, the orientation will be explained using the longitudinal axis, vertical axis, and transverse axis arbitrarily defined by the three hemispheres L, V, and T shown in Figures 1 to 6.

[0049] Figure 1 shows a subcutaneous implant 2 according to an embodiment of the present invention. This subcutaneous implant 2 is intended to be placed under the skin of a living organism, more specifically, under the skin of a patient suffering from heart failure. The subcutaneous implant 2 may collect information about the patient's cardiac and / or respiratory function and transmit it to an external collection device. This information can then be analyzed, for example, by a healthcare professional to identify the risk of developing an uncompensated episode of heart failure.

[0050] As shown in Figure 1, the subcutaneous implant 2 comprises a titanium housing 4 having 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 illustrated embodiment, the housing 4 is formed by three distinct parts, each of which is assigned to a single zone 6, 8, or 10 distinct from the other zones 6, 8, or 10.

[0051] The subcutaneous implant 2 extends along its principal longitudinal extension direction, that is, parallel to the axis L. The first zone 6 extends from the first longitudinal end 12 of the subcutaneous implant 2 parallel to the principal longitudinal extension direction of the subcutaneous implant 2. The third zone 10 extends from the second longitudinal end 14, which is opposite to the first longitudinal end 12, parallel to the principal longitudinal extension direction of the subcutaneous implant 2.

[0052] In the illustrated embodiment, the first zone 6 of the subcutaneous implant 2 comprises a measuring instrument and a communication instrument. More specifically, the measuring instrument comprises at least one first electrode 16, and the communication instrument comprises at least one communication antenna 18.

[0053] The first electrode 16 works in conjunction with the second electrode, which will be described in more detail below, to collect at least information about the patient's cardiac activity, enabling the collection of electrical data that, for example, allows for the creation of an electrocardiogram.

[0054] The communication antenna 18 is a loop antenna having two connection points as described herein, but this embodiment does not limit the invention, and the antenna is not limited to this insofar as it enables the transmission of information collected by the measuring instrument to a collection device located outside the patient's body. In the illustrated embodiment, it should be noted that the first electrode 16 and the communication antenna 18 are embedded in epoxy resin, and the first electrode is positioned on the surface of the epoxy resin. To hold the first electrode 6 in place within the epoxy resin, the first electrode is provided with an anchor 17, which can be seen in more detail in Figure 2.

[0055] The first zone 6 and the second zone 8 are separated from each other by a partition wall 20 electrically connected to the housing 4. This partition wall 20 extends in a primary lateral extension direction, that is, parallel to the axis T, and this extension direction of the partition wall 20 is substantially perpendicular to the extension direction of the subcutaneous implant 2.

[0056] The partition wall 20 forms an airtight wall between the portion of the housing 4 defining the first zone 6 and the portion of the housing 4 defining the second zone 8. Furthermore, the partition wall 20 is provided with holes through which connection pins 22 of measuring instruments and / or communication equipment pass.

[0057] More specifically, Figure 1 shows three connection pins 22. One of these connection pins 22 allows the first electrode 16 to be connected to the printed circuit board 30, which can be seen in Figure 2, housed in the portion of the housing 4 that defines the second zone 8. The other two connection pins 22 allow the communication antenna 18 to be connected to the printed circuit board 30. Naturally, these connection pins 22 extend at least partially from the first zone 6 into the second zone 8.

[0058] It should be noted that the connecting pin 22 is fixed to the partition wall 20 by soldering the pin to the partition wall 20 at the hole. After the connecting pin 22 is fixed to the partition wall 20, the hole is sealed airtight.

[0059] The portion of the housing 4 defining the second zone 8 has an opening 26, as can be seen in Figure 6, which is closed by a cap 28 equipped with sealing control means 31, which will be described in more detail with reference to Figure 6.

[0060] Furthermore, the third zone 10 includes an electrical energy storage means 32, which can be seen in Figure 2. More specifically, in the illustrated embodiment, the portion of the housing 4 defining the third zone 10 is formed by a first half shell 34 and a second half shell 36. These two half shells 34, 36 are fixed to each other to define an inner housing in which the electrical energy storage means 32 is housed.

[0061] More specifically, the first split shell 34 and the second split shell 36 have complementary shapes and dimensions that allow the edges of the split shells 34,36 to be joined to the edge of the other split shell 34,36 to form an inner housing for the electrical energy storage means 32. The split shells 34,36 are fixed to each other, for example, by laser soldering, after the electrical energy storage means 32 is placed between the split shells 34,36.

[0062] The electrical energy storage means 32 is held in a stable position by silicone to prevent it from moving within the inner housing defined by the split shells 34 and 36. Furthermore, the electrical energy storage means 32 is electrically insulated from the split shells 34 and 36 by an insulating material, such as Kapton.

[0063] It should be noted that in an alternative embodiment of the present invention, the portion of the housing 4 defining the third zone 10 may be directly formed by the electrical energy storage means 32. In other words, in this alternative embodiment, the subcutaneous implant 2 does not have a split shell 34, 36, and the outer case of the electrical energy storage means 32 directly forms the portion of the housing 4 defining the third zone 10.

[0064] Furthermore, the portion of the housing 4 that defines the third zone 10, that is, the portion of the housing 4 formed by the split shells 34 and 36, forms a second electrode that works in conjunction with the first electrode 16 for collecting information about the patient's cardiac activity.

[0065] More specifically, in the illustrated embodiment, the subcutaneous implant 2 includes a parylene coating surrounding the housing 4 and extending from the partition wall 20 to the second longitudinal end 14 of the subcutaneous implant 2. Only a portion of the split shell 34,36 does not contain parylene, in which case this portion forms the second electrode. Advantageously, the parylene-free portion is on the same side of the subcutaneous implant 2 as the first electrode 16, but as far away from the first electrode 16 as possible. Furthermore, the first electrode 16 and the parylene-free portion may be centered on the same axis parallel to the main longitudinal extension direction of the subcutaneous implant 2.

[0066] Figure 2 shows an exploded view of the subcutaneous implant 2, which can be seen in Figure 1. Figure 2 makes it possible to highlight the printed circuit board 30 and the support 38 in which the printed circuit board 30 is housed.

[0067] The printed circuit board 30 comprises several electronic components involved in the operation of the subcutaneous implant 2. Among these electronic components, which can be seen in Figure 2, are a microcontroller 40, components of a transducer 42, and inductive elements in the illustrated configuration. These electronic components are supplied with electrical energy by an electrical energy storage means 32 connected to these electronic components by connecting conductor paths (not shown).

[0068] The converter 42 makes it possible to supply the microcontroller 40 with a voltage lower than the voltage supplied by the electrical energy storage means 32. Naturally, the voltage input to the converter 42 is higher than the voltage output by the converter 42.

[0069] Furthermore, the printed circuit board 30 is provided with a number of notches 44 intended to accommodate the aforementioned connection pins 22. As shown in Figure 2, the printed circuit board 30 has five notches 44. Three of these notches 44 are intended to accommodate the connection pins 22 of the first electrode 16 and two connection pins 22 of the communication antenna 18, including one pin that allows the communication antenna to be connected to ground, and two notches 44 are intended to accommodate connection pins 22 that allow at least the housing 4 to be connected to ground.

[0070] The connection pin 22 connected to ground is in contact with the partition wall 20. Naturally, the connection pin 22 connected to ground is electrically connected to the housing 4. It should be noted that the connection pin 22 of the first electrode 16 and the connection pin 22 of the communication antenna 18 are electrically insulated from the partition wall 20.

[0071] The support 38 is configured to be housed in the portion of the housing 4 that defines the second zone 8. The support 38 has dimensions and a shape complementary to the dimensions and shape of the housing 4, thereby enabling the support to be housed within the rectangular tubular housing 4 that defines the second zone 8. This configuration of the support 38 prevents the support 38 from moving within the housing 4.

[0072] More specifically, the support 38 extends in the longitudinal direction and has a U-shape in a cross-sectional plane perpendicular to the longitudinal direction, comprising a base formed by a partition wall 54 and branch portions arranged on both sides of the partition wall and formed by lateral edge portions 55.

[0073] Furthermore, the support 38 is provided with support edges 46 that project inward from the lateral edges of the support. These support edges 46 are configured to hold the printed circuit board 30 inside the support 38. More specifically, the support edges 46 are involved in defining guide rails 48 at each lateral end of the support 38. These guide rails 48 allow the printed circuit board 30 to be housed inside the support 38 by sliding.

[0074] Such sliding of the printed circuit board 30 within the support 38 allows for precise positioning of the printed circuit board 30 relative to the first zone 6 and the third zone 10 after the subcutaneous implant 2 has been assembled. In particular, such positioning of the printed circuit board 30 allows the connecting pins 22 to be housed within the assigned notches 44.

[0075] As shown in Figure 2, the third zone 10 defined by the split shells 34 and 36 comprises an electrical energy storage means 32, which includes a connection tab 50 that allows the electrical energy storage means 32 to be electrically connected to the printed circuit board 30.

[0076] Referring to Figures 2 and 3, it is noteworthy that the printed circuit board 30 has an accelerometer 52, as can be seen in Figure 3, on the side opposite to the side where the microcontroller 40 and the transducer 42 are located. This accelerometer 52 is involved in collecting information about cardiac and / or respiratory function.

[0077] Since the support 38 is made of a non-conductive plastic material, inserting the support between the electronic component and the titanium housing ensures that short circuits are impossible.

[0078] The partition wall 54 extends between the accelerometer 52 and the housing 4 in a direction parallel to the printed circuit board 30 when the subcutaneous implant 2 is assembled.

[0079] The accelerometer 52 comprises a first surface fixed to the printed circuit board and a second opposite surface that is at least partially metallic and faces the wall of the housing 4. The partition wall 54 extends between the housing 4 and the accelerometer 52, more specifically between the housing and the second surface of the accelerometer, as described above, but at a distance equal to 0.05 mm to 1 mm, preferably 0.1 mm to 0.5 mm, more preferably 0.2 mm, from the housing and the accelerometer. As described above, the partition wall 54 of the support 38 inserted between the accelerometer 52 and the housing makes it possible to ensure electrical insulation of the accelerometer 52 from the housing 4.

[0080] Furthermore, the partition wall 54 includes a gap 56 that is at least partially vertically aligned with the accelerometer 52 when the printed circuit board 30 is housed within the support 38. In the illustrated embodiment, this gap 56 extends parallel to the longitudinal principal extension direction of the support 38. The gap 56 is extended by a larger window 58 formed on the opposite side of the opening 26, which will be described in more detail with reference to Figure 6.

[0081] Figure 3 shows the arrangement of the gap 56 and window 58 relative to the printed circuit board 30 when the printed circuit board 30 is housed within the support 38. In particular, Figure 3 shows that the window 58 is positioned facing two connection zones 62 present on the printed circuit board 30.

[0082] The connection tabs 50 of the electrical energy storage means 32 are intended to be soldered to the connection zone 62 so that the electrical energy storage means 32 can supply power to various electronic components arranged on the printed circuit board 30.

[0083] The presence of a window 58 in the partition wall creates a separation element 60 formed at the longitudinal end of the support 38 proximal to the third zone 10. This separation element 60 extends laterally from one lateral edge to the opposite lateral edge of the support 38 between the connecting tab 50 and the housing 4. The separation element 60 is configured to contribute to the electrical insulation of the connecting tab 50 from the housing 4.

[0084] In the first zone 6, the housing 4 is provided with a fixation hole 64 that penetrates vertically through the subcutaneous implant 2. This fixation hole 64 allows the subcutaneous implant 2 to be fixed to the patient's implantation site, for example, by a wire.

[0085] Figure 4 makes it possible to highlight in more detail the separation element 60 described above and the role of this separation element 60 in electrical insulation. More specifically, Figure 4 shows a local cross-sectional view of the subcutaneous implant 2 with cross-sectional planes extending in the longitudinal and vertical directions, that is, parallel to the axes L and V.

[0086] As shown in Figure 4, the connection tab 50 of the electrical energy storage means 32 extends partially into the second zone 8 and is connected to the connection zone 62 by solder. Like the other connection tab 50, this connection tab 50 has a curved shape between the connection zone 62 and the electrical energy storage means 32.

[0087] More specifically, the connecting tab 50 has a portion that extends in a plane parallel to the longitudinal principal elongation direction of the subcutaneous implant 2, and this portion of the connecting tab 50 forms the soldering portion to the connection zone 62. The connecting tab 50 has another portion that extends between the electrical energy storage means 32 and a flat portion having a curved portion that is involved in forming the curved shape of the connecting tab 50.

[0088] The curved shape of the connection tab 50 makes it possible to increase the heat conduction distance between the connection zone 62 and the electrical energy storage means 32. This increase in conduction distance makes it possible to protect the electrical energy storage means 32 from the risk of degradation due to the heat released by the solder.

[0089] As shown in Figure 4, the curvature of the connecting tab 50 results in the curved portion of the connecting tab 50 being brought significantly closer to the housing 4. The isolation element 60 of the support 3 is positioned between the connecting tab and the housing 4, more specifically between the curved portion of the connecting tab 50 and the housing 4. This position of the isolation element 60 allows the support 38 to participate in the electrical insulation of the connecting tab 50 from the housing 4, particularly when the electrical energy storage means 32 is assembled to the housing 4 and, for this reason, takes an inclined position during assembly in which the curvature of the connecting tab 50 tends to approach the portion of the housing.

[0090] It should be noted that the portion of housing 4 defining the second zone 8 is fixed to the portion of housing 4 defining the third zone 10 by a fixed zone 65. In this fixed zone 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 facing the second zone 8. In the illustrated embodiment, the longitudinal edge of the second zone 8 facing the third zone 10 has a shoulder that cooperates with the longitudinal edge of the third zone 10.

[0091] It should be noted that the portion of the housing 4 defining the third zone 10 is fixed to the portion of the housing 4 defining the second zone 8, which has an opening 26 provided in the second zone 8 and is not yet covered by the cap 28, before the connection tab 50 is fixed to the printed circuit board 30. Naturally, the opening 26 formed in the housing 4 defining the second zone 8 and the window 58 formed in the support 38 allow the passage of soldering means for fixing the connection tab 50 to the printed circuit board 30. In the illustrated embodiment, such soldering of the connection tab 50 to the printed circuit board 30 is performed by brazing.

[0092] Figure 5 shows one feature such that, when the subcutaneous implant is assembled, the second zone 8 includes adhesive means 66 that at least partially embed the printed circuit board and electronic components. More specifically, the adhesive means 66 partially extends within the second zone 8 while embedding only a portion of the printed circuit board. In other words, the second zone 8 comprises a first portion with adhesive means 66 and a second portion without adhesive means 66, and these two portions are continuous with each other in the longitudinal direction.

[0093] The first portion of the second zone 8 extends from the first zone 6 to the third zone 10, and the second portion of the second zone 8 extends from the third zone 10 to the first zone 6. Naturally, the first and second portions of the second zone 8 extend continuously in the longitudinal direction within the second zone 8 from the first zone 6 to the third zone 10.

[0094] By positioning the adhesive means 66 within the first portion, elements present within the first portion of the second zone 8 are embedded within the adhesive means 66. More specifically, the adhesive means 66 extends at least partially over the accelerometer 52, as shown in Figure 5.

[0095] In particular, the adhesive means 66 is an adhesive that is placed in a liquid state within the first portion of the second zone 8, and then solidified by polymerization, particularly by heating, to fix its position within the first portion. In particular, such infusion of the adhesive means 66 is carried out by a subcutaneous implant without a third zone, which allows the adhesive to be introduced into the second portion of the second zone on the side opposite to the first zone, and if the implant is in a vertical position, the liquid adhesive means can be flowed toward the partition wall 20, and the adhesive means is injected in a specified amount without overflowing beyond the second portion of the second zone, thereby filling the entire first portion, and several electronic components, particularly the microcontroller 40, the transducer 42 and at least partially the accelerometer 52, are at least partially embedded.

[0096] The adhesive means 66 fills the entirety of the first portion, extending longitudinally to the second portion, and extending transversely and vertically from one wall of the housing to the opposite wall. Thus, the adhesive means 66 extends through the gap 56 of the support 38 between the accelerometer 52 and the housing 4, between the accelerometer 52 and the partition wall 54, and between the partition wall 54 and the housing 4.

[0097] Figure 5 shows in more detail the boundary between the first and second parts of the second zone, along with the end face of the adhesive means 66. Notably, the end face of this adhesive means is offset longitudinally with respect to the accelerometer, so that a small portion of the accelerometer does not have the adhesive means 66 and thus fits into the second part of the second zone. This portion of the accelerometer does not have the adhesive means 66, thereby preventing the adhesive means 66 from overflowing into the connection zone 62 while soldering the connection tab 50 of the electrical energy storage means 32 to the printed circuit board 30.

[0098] Of particular note is that the dimensions of the space between the accelerometer 52 and the partition wall 54 allow the adhesive means 66 to spread between the partition wall 54 and the accelerometer 52 by capillary action. Such capillary propagation, which enables the adhesive to be present across the entire surface of the accelerometer, is facilitated by the presence of the gap 56, which limits the area of ​​the surface over which the adhesive is to be propagated by capillary action, and the adhesive means 66 spreads laterally between the partition wall 54 and the accelerometer 52, particularly starting from this gap.

[0099] When the third zone 10 is attached to the second zone 8, it should be noted that the connecting tab 50 extends strictly within the second portion of the second zone 8, as well as the connecting zone 62. Naturally, the second portion of the second zone 8 does not have adhesive means 66, which allows the connecting tab 50 of the electrical energy storage means 32 to be fixed to the connecting zone 62.

[0100] Figure 6 shows a cross-sectional view of the subcutaneous implant 2 with cross-sectional planes extending vertically and transversely, that is, parallel to the V-axis and T-axis. Figures 6 and 7, which show the cap 28 in more detail, make it possible to highlight the sealing control means 31 mentioned above.

[0101] As shown in Figure 6, the cap 28 is positioned in an opening 26 formed in the portion of the housing 4 that defines the second zone 8, facing the connection zone 62. Naturally, this opening 26 is formed in the second portion, which allows the connection tab 50 to be connected to the connection zone 62. The cap 28 is attached to close the opening 26 after the connection tab 50 has been soldered to the connection zone 62.

[0102] The cap 28 comprises an inner surface 70 positioned facing the printed circuit board 30 when the subcutaneous implant 2 is assembled, and an outer surface 72 opposite to the inner surface 70. The cap includes an orifice 68 that forms part of the sealing control means 31 and penetrates the cap from the inner surface 70 to the outer surface 72.

[0103] Furthermore, the sealing control means 31 includes a shield 74 fixed to the inner surface 70 of the cap 28. The inner surface 70 of the cap 28 also includes a material recess 76 formed to surround the orifice 68. This material recess 76 is such that it forms a space between a portion of the shield 74 and the cap 28, and the shield 74 is sized such that it does not completely cover the material recess in the longitudinal direction perpendicular to the main extension direction of the shield, as can be seen in Figure 6, for example. For example, as can be seen in Figure 7, where the shield 74 is shown with a dotted line to clearly illustrate the material recess 76 partially covered by the shield 74, the material recess may be circular, the shield 74 may be rectangular, and the diameter of the material recess 76 is greater than the width of the shield 74 and less than the length of the shield 74. Thus, in order to properly complete the sealing test, the shield 74 can be soldered to the inner surface 70 of the cap without covering the zone of the material recess through which the control gas injected through the opening 68 may pass, prior to closing the opening 68 by, for example, a laser shot. In other words, when the orifice 68 is not sealed, fluid communication is possible between the inside and outside of the housing via the material recess 76 and the orifice 68, bypassing the shield 74.

[0104] More specifically, after the implant is fully assembled, the sealing control means 31 allows for sealing control by circulating a neutral gas through the orifice 68. It is required to ensure that the gas does not leak out through any opening in the housing other than the orifice 68. After the sealing test is completed, the orifice is sealed by a laser shot. The shield 74 ensures that the laser shot does not damage any electronic components located on the printed circuit board directly facing the orifice 68. Figure 6 shows the housing in part, and it should be understood that the orifice 68 is shown in a configuration where it has not yet been sealed by the laser shot, so that its presence can be recognized.

[0105] Therefore, the sealing control means is configured such that, during the sealing control step, the orifice 68 allows for the introduction of a sealing control gas, and then, when the orifice is closed by a laser shot, the shield 74 protects the electronic components, and the material recess 76 allows for the passage of gas next to the shield 74.

[0106] Prior to the sealing test and the closure of the orifice by laser shot, the subcutaneous implant 2 is assembled in a series of steps, allowing the first portion of the second zone to be embedded in the adhesive means 66 while enabling the different zones to be fixed to each other. For this purpose, according to the present invention, the subcutaneous implant is assembled by a specific assembly method.

[0107] In the following description of the assembly method, each zone of the housing is formed by specific parts, and these different parts are soldered to each other during the process, with each referring to a different drawing.

[0108] The assembly method involves a first step of housing the printed circuit board 30 within the support 38. In particular, the printed circuit board is slid inside the support using guide rails formed laterally within the support.

[0109] In the second step, a support 38 comprising a printed circuit board 30 is partially housed within a portion of the housing 4 that forms a second zone 8, and this subassembly is pressed against the first zone 6, more specifically, the partition wall 20. The support 38 is said to be partially housed insofar as it is important that the notches 44 in the printed circuit board, which are intended to accommodate various connection pins 22, protrude beyond the housing so that not only the connection pins 22 of measuring and communication equipment, but also the connection pins 22 connected to ground, can be fixed to the printed circuit board 30. To this end, the support 38 is pressed against the partition wall 20 so that the connection pins 22 are housed within their assigned notches.

[0110] The assembly method involves, after the connecting pins 22 are fixed to the printed circuit board 30, sliding the portion of the housing that forms the second zone 8 along the support 38, and then performing an additional second step in which the portion of the housing that forms the first zone 6, more specifically, is brought into contact with the partition wall 20. Subsequently, the portion of the housing 4 defining the second zone 8 is fixed to the portion of the housing 4 defining the first zone 6, particularly by soldering.

[0111] The assembly method involves a third step, performed after the second step and an additional second step, in which a portion of the second zone 8 is embedded within the adhesive means 66. Naturally, as described above, during this third step, the first portion of the second zone 8 is embedded within the adhesive means 66. To this end, the subassembly formed by the first zone 6 and the second zone 8 is positioned vertically, thereby ensuring that the liquid adhesive is carried by gravity toward the partition wall and injected through the open side of the subassembly opposite the first zone.

[0112] The adhesive is injected in an appropriate amount to adequately fill the first portion of the second zone, that is, to embed the microcontroller 40 and the transducer 42 in particular, and to at least partially embed the accelerometer. Furthermore, the third step includes time for the adhesive means to dry.

[0113] The assembly method, after the first portion of the second zone 8 is embedded in the adhesive means and the adhesive means has cured and fixed the accelerometer and housing against vibration, involves performing a fourth step in which the portion of the housing 4 defining the third zone 10 is fixed to the portion of the housing defining the second zone 8. After the adhesive means has cured, the subassembly formed by the first zone 6 and the second zone 8 may be brought to another position more suitable by the fixing work of the fourth step. The fixing between the second zone 8 and the third zone 10 is performed in accordance with what has been described above with respect to the fixing zone 65.

[0114] When the third zone 10 of the housing 4 is fixed to the second zone 8 of the housing 4, the connection tab 50 of the electrical energy storage means 32 is fixed to the printed circuit board 30. This fixing is done by soldering the connection tab 50 through the opening 26 into the fixing zone 65.

[0115] In the final step of the method, after the connecting tab 50 is secured to the printed circuit board 30, the cap 28 is positioned to close the opening 26, thereby controlling the sealing as described above.

[0116] The connection pins 22 are fixed to the printed circuit board 30 in the first step, and to the assigned measuring and communication equipment in the second step. More specifically, the step of fixing the connection pins 22 to the printed circuit board 30 is performed before sealing control, while the step of fixing the connection pins 22 to the measuring and communication equipment is performed after sealing control.

[0117] In fact, to perform sealing control, the subcutaneous implant 2 is placed inside the enclosure, and a gas, in this case a neutral gas, is injected into the enclosure under pressure. The presence of connection pins fixed to the printed circuit board makes it possible to ensure the airtightness of the second zone at this point. Since epoxy resin is not suitable for such testing, after sealing control, the first electrode 6 and the communication antenna 18 are embedded in epoxy resin.

[0118] In fact, the present invention achieves its objectives by providing a subcutaneous implant in which the collection and transmission of information are particularly effective while optimizing the compactness of the subcutaneous implant.

Claims

1. A subcutaneous implant (2) for introduction under the skin of a living organism to collect information relating to the cardiac and / or respiratory activity of the living organism, comprising a housing (4) having at least one first zone (6) housing measuring instruments and / or communication instruments, a second zone (8) housing at least one printed circuit board (30), and a third zone (10) housing electrical energy storage means (32), wherein the printed circuit board (30) comprises a plurality of electronic components including at least one accelerometer (52), and the printed circuit board (30) is housed in a support (38) configured to position the printed circuit board (30) at least with respect to the first zone (6) and / or the third zone (10) and to participate in the electrical insulation of at least some of the electronic components from the housing (4).

2. The subcutaneous implant (2) according to claim 1, wherein the second zone (8) comprises adhesive means (66) for embedding at least some of the electronic components.

3. The subcutaneous implant (2) according to claim 1 or 2, wherein the support (38) is provided laterally with a support edge (46) configured to hold the printed circuit board (30).

4. The subcutaneous implant (2) according to any one of claims 1 to 3, wherein the first zone (6) and the second zone (8) are separated from each other by a partitioning wall (20), the partitioning wall (20) is electrically connected to the housing (4) and has holes through which the connection pins (22) of the measuring instrument and / or communication instrument pass.

5. The subcutaneous implant (2) according to claim 3 or 4, referencing claim 2, wherein the accelerometer (52) is fixed to and electrically connected to the printed circuit board (30) and at least partially embedded within the adhesive means (66).

6. The subcutaneous implant (2) according to any one of claims 1 to 5, 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 contribute to the electrical insulation of the accelerometer (52) from the housing (4).

7. The subcutaneous implant (2) according to any one of claims 1 to 6, wherein the electrical energy storage means (32) comprises a connection tab (50) that extends at least partially within the second zone (8) and is intended to be fixed to at least one connection conductor path of the printed circuit board (30), and the support (38) comprises at least one isolation element (60) positioned between the connection tab (50) and the housing (4), the at least one isolation element (60) being configured to be involved in the electrical insulation of the connection tab (50) from the housing (4).

8. The subcutaneous implant (2) according to claim 7, referencing claim 2, wherein the second zone (8) comprises a first portion having the adhesive means (66) and a second portion separate from the first portion and not having the adhesive means (66), and the connecting tab (50) is formed within the second portion of the second zone (8).

9. The subcutaneous implant (2) according to any one of claims 1 to 8, wherein the second zone (8) comprises an opening (26) that is closed by a cap (28).

10. The subcutaneous implant (2) according to claims 8 and 9, wherein the opening (26) is formed in the second portion.

11. The subcutaneous implant (2) according to claim 9 or 10, wherein the cap (28) comprises a sealing control means (31), an inner surface (70) positioned facing the printed circuit board (30), and an outer surface (72) opposite to the inner surface (70), a shield (74) fixed to the inner surface (70) of the cap (28), and the inner surface (70) comprises a material recess (76) configured to form a space between the shield (74) and the cap (28) facing the sealing control means (31).

12. The subcutaneous implant (2) according to any one of claims 1 to 11, wherein the housing (4) is formed by three parts, each assigned to a single zone (6, 8, 10).

13. A method for assembling a subcutaneous implant (2) according to any one of claims 1 to 12, referencing claim 2, - At least one first step of housing the printed circuit board (30) within the support (38), - At least one second step of housing the support (38) at least partially within the second zone (8) of the housing (4) and supporting it in the first zone (6), - At least one third step of embedding a portion of the second zone (8) within the adhesive means (66) The method of carrying out or assembling something.

14. The assembly method according to claim 13, referencing claim 4, wherein in the second step, the connecting pins (22) of the measuring instrument and / or communication instrument are soldered to the conductive paths formed in the printed circuit board (30) at the notches (44) of the printed circuit board.

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