IMPLANTABLE MEDICAL DEVICE COMPRISING A METAL/CERAMICS COMPOSITE HOUSING

Abstract

The implantable medical device comprises an elongated composite tubular body comprising a tubular part made of a biocompatible and RF wave permeable dielectric material and a tubular part made of a biocompatible metallic material. The dielectric tubular part and the metallic tubular part are arranged end-to-end at their interface against the respective planar end faces thereof, without being fit into each other. The interface comprises a planar brazing sealing to each other the two opposite respective planar end faces of the dielectric material tubular part and of the metallic material tubular part. With a dielectric material that is a high-purity alumina ceramic and a metallic material that is titanium, the brazing is obtained by gold brazing on a TiNb primer metallization layer deposited on the planar end face of the dielectric material tubular part.

Claims

1. An implantable medical device comprising an elongated composite tubular body including at least one tubular part made of a biocompatible and RF wave permeable dielectric material, and at least one tubular part made of a biocompatible metallic material, wherein, at an interface between the dielectric material tubular part and the metallic material tubular part, the dielectric material tubular part and the metallic material tubular part are arranged end-to-end against respective planar end faces thereof without being fit into each other, and wherein the interface comprises a planar brazing sealing to each other the two opposite respective planar end faces of the dielectric material tubular part and of the metallic material tubular part.

2. The device of claim 1, wherein the interface comprises no overlapping and no fitting of the dielectric material tubular part with the metallic material tubular part.

3. The device of claim 1, wherein the elongated tubular body has an isodiametric outer surface, the dielectric material tubular part and the metallic material tubular part having a same outer diameter on either side of the interface.

4. The device of claim 1, wherein the elongated tubular body has an isodiametric inner surface, the dielectric material tubular part and the metallic material tubular part having a same inner diameter on either side of the interface.

5. The device of claim 4, comprising a central tubular support part housed inside the elongated tubular body, the central support tubular part having an outer diameter adjusted to the inner diameter of the dielectric material tubular part and of the metallic material tubular part.

6. The device of claim 1, wherein the dielectric material is a ceramic of the group comprising alumina and zirconia, and the metallic material is titanium.

7. The device of claim 6, wherein the dielectric material is an alumina ceramic of purity 99.5%.

8. The device of claim 6, wherein the brazing is a brazing obtained by gold brazing on a TiNb primer metallization layer deposited on the planar end face of the tubular part made of dielectric material.

9. The device of claim 1, wherein the dielectric material tubular part and the metallic material tubular part extend in the peripheral direction over the whole circumference of the tubular body.

10. The device of claim 1, wherein the composite elongated tubular body further houses at least one RF antenna, and wherein the dielectric material tubular part is located axially and circumferentially in alignment with the at least one RF antenna.

11. The device of claim 1, wherein the elongated tubular body comprises a central dielectric material tubular element, open at its two ends, and two lateral metallic material tubular elements arranged on either side of the central dielectric material tubular element.

12. The device of claim 11, wherein the two lateral metallic material tubular elements are electrically isolated from each other by the central dielectric material tubular element and form between the two distal and proximal ends of the device body a dipole coupled to detection and/or stimulation circuits of the device, for the detection and/or stimulation of an organ with which the device is in contact.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0035] The foregoing and other objects, aspects and advantages of the invention will be better understood from the following detailed description of a preferred embodiment of the invention with reference to the appended drawings, in which the same numerals refer to identical or functionally similar features over the different figures.

[0036] FIG. 1 illustrates medical devices of the leadless capsule type in their environment, with various examples of implantation sites in, on, or near the heart of a patient.

[0037] FIG. 2 is a longitudinal overall view of a leadless capsule.

[0038] FIG. 3 shows, as a block diagram, the main internal constitutive elements of the leadless capsule.

[0039] FIG. 4 is a longitudinal cross-section of the central tubular part of the leadless capsule of FIG. 2, showing the mechanical configuration of the different elements located inside the tubular body.

[0040] FIG. 5 is a cross-sectional view of the tubular body of the capsule of FIG. 4, separately shown before the positioning of the internal elements.

[0041] FIGS. 6a to 6f are detailed views, corresponding to mark VI in FIG. 5, illustrating various ways for assembling the two constitutive elements of the composite tube of FIG. 5.

DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT OF THE INVENTION

[0042] An exemplary embodiment of a device implementing the teachings of the invention will now be described, with reference to the drawings.

[0043] In FIG. 1 are shown various possibilities of implantation sites for a device of the leadless type, in a cardiac stimulation application. To this respect, capsule 10 is implanted into a cavity of the myocardium (endocavitary implant), for example at the apex of the right ventricle. As a variant, the capsule may also be implanted on the right interventricular septum, as at 10, or also on an atrial wall, as at 10. The device may also be an epicardial capsule placed on an external region of the myocardium, as at 10.

[0044] In any case, the leadless capsule is fixed to the cardiac wall by means of a protruding anchoring system penetrating the cardiac tissue for holding it to the implantation site. Other anchoring systems can be used, and do not modify in any way the implementation of the present invention.

[0045] The leadless capsules are provided with wireless transmitter/receiver means for the communication with a remote equipment 100, implanted into or external to the patient for the transmission of signals from the capsule 10 to the equipment 100 and, conversely, from the equipment 100 to the capsule 10. In the case several leadless capsules are implanted at the same time, RF communication may also take place directly from one capsule to another capsule, for example between capsules 10 and 10 of FIG. 1 in the case of a dual-chamber, atrial and ventricular detection/stimulation system.

[0046] FIG. 2 is a longitudinal overall view of a leadless capsule 10 in external form of a cylindrical tubular implant body 12 enclosing the various electronic and power supply circuits of the capsule.

[0047] The typical dimensions of such a capsule are a diameter of the order of 6 mm and a length of about 25-40 mm.

[0048] The elongated tubular body 12 is closed at its distal end by an element 14 carrying a helical screw 16 for anchoring the capsule to a wall of a cardiac cavity, as illustrated hereinabove with respect to FIG. 1 (the anchoring mode being of course in no way limitative). A detection/stimulation electrode 18, in contact with the cardiac tissue at the implantation side, operates to collect cardiac depolarization potentials and/or to apply stimulation pulses (in certain embodiments, the function of electrode 18 is performed by the anchoring screw 16, which is accordingly an active, electrically conductive screw connected to the detection/stimulation circuit of the capsule). The electrode 18 in contact with the tissues is generally a cathode, and it is associated with an anode whose function is fulfilled by a second, distinct electrode, most often an annular electrode such as at 20.

[0049] At the opposite, proximal end, the elongated tubular body is closed by an element 22 having an atraumatic rounded shape and provided with suitable gripping means 24, for the temporary connection of the capsule 10 to a guide-catheter or another accessory usable at the time of implantation or explanation of the capsule.

[0050] FIG. 3 is a synoptic of the various electric and electronic circuits built in to capsule, shown as functional blocks. These circuits are advantageously made as an ASIC or a combination of ASICs.

[0051] Block 26 denotes a heart depolarization wave detection circuit, connected to electrode 18 in contact with the cardiac tissue and to the opposite electrode 20. This detection block 26 comprises filters and means for analog and/or digital processing of the collected signal. The processed signal is applied to the input of a computer 28 associated to a memory 30. The electronic unit also includes a stimulation circuit 32 operating under the control of computer 28 to issue as necessary myocardium stimulation pulses to the electrode system 18, 20. The capsule may also include built-in sensors such as an accelerometer (G-sensor) 34 coupled to the computer 28.

[0052] The capsule 10 further includes a radiofrequency (RF) module 36 associated to one or several transmission/reception antennas 38, 38. In the illustrated example, the RF module is a transmitter/receiver module for wireless communication with a remote equipment 100 (FIG. 1) or with other implanted capsules (for example, in the configuration of a dual-chamber ventricular and atrial detection/stimulation system). The RF module, in another case, may be used for other purposes than the communication of data, in particular it may serve to wirelessly couple the capsule to an external device for inductive charging of the battery, i.e. mainly from the magnetic component of the electromagnetic RF wave.

[0053] The capsule 10 further includes, for the power supply thereof, an energy harvesting module typically comprising an energy harvester 40 comprising an inertial unit that oscillates inside the capsule under the effect of the multiple external stresses to which is subjected the capsule, and performs a function of mechanical-electrical transducer to convert these mechanical stresses into electrical charges, so as to produce a variable electrical signal S that is sent to an energy harvesting circuit 42. Circuit 42 rectifies and regulates the signal S so as to output a stabilized direct voltage or current for powering all the electronic circuits of the capsule, as well as for charging a built-in energy storage component 44, for example a rechargeable battery or a high-performance capacitor.

[0054] FIG. 4 is a schematic cross-sectional view of the capsule of FIG. 2 showing the different elements arranged inside the elongated tubular body 12.

[0055] The inertial unit of the energy harvester module, comprising a piezoelectric beam 46 clamped at one of its end 48 and whose opposite, free end, is coupled to an inertial mobile mass 50, is particularly illustrated in this figure. The piezoelectric beam 46 is an elastically deformable flexible beam that constitutes, with the inertial mass 28, a pendular system of the mass-spring type that, due to the inertia of the mass 50, oscillates as soon as the elastic beam 46 is deflected from its stable rest position. The piezoelectric beam 46 further performs a function of mechanical-electrical transducer for converting into electrical charges the mechanical stress that is applied to it when it is bent under the effect of the inertia of the mass 50. These electrical charges are collected by electrodes formed at the surface of the beam 46 to produce the electrical signal S that, after rectification, stabilization and filtering, will power the various electronic circuits of the capsule.

[0056] The elongated tubular body 12 further houses an inner part 52 serving both as a support for the piezoelectric beam 46 at its clamping point 48, and as a support for printed circuit boards (PCBs) such as 54 and 54. Indeed, in order to optimize as far as possible the available space inside the capsule, all built-in electronics are made as electronic circuits advantageously mounted on printed circuit boards 54, 54 located near the inner wall of the elongated tubular body (so as to clear up the central space for the oscillating beam 46), the two circuits 54, 54 being connected to each other by a flexible conductor ribbon.

[0057] In addition to the various integrated circuits and discrete components of the electronic unit, the PCBs 54, 54 support the antennas 38, 38, wherein these latter can be made as added discrete components, or as tracks etched on the PCBs.

[0058] The presence of two antennas 38, 38 arranged opposite to each other makes it possible to widen the whole radiation diagram of the capsule, making the latter almost omnidirectional, each of the two antennas 38 or 38 covering a substantially hemispherical sector of the radiation diagram. The two-antenna embodiment is however not limitative in any way, and the system may include for example three antennas arranged at 120, four antennas at 90, etc., providing an almost omnidirectional radiation pattern. In order for the RF waves to be able to pass through the body 12, the latter is made as a composite tube with, in alignment with the antennas RF 38, 38, an RF wave permeable part, the rest of the composite tube being made of titanium, i.e. in the areas that do not need to let an RF radiation through.

[0059] In FIG. 5 is illustrated separately such a composite tube, constituting the elongated tubular body 12 of the capsule 10.

[0060] The latter comprises a central part 60, preferably fully tubular, made of an RF wave permeable dielectric material in the region located in alignment with the antennas 38, 38 carried by the PCBs 54, 54.

[0061] On either side of the central tubular part 60 made of a dielectric material, the tube is formed by two metallic tubular elements 62, 64 extending in the regions located away from the antennas 38, 38 and that will hence have no or little incidence on the whole radiation diagram of the system of antennas 38, 38.

[0062] It will be noted that, in this configuration, from the electrical point of view, the two distal 62 and proximal 64 tubular elements are isolated by the central tubular part 60 made of dielectric material, interposed between them. This electrical isolation, which is a direct consequence of the composite design of the tubular body, may be advantageous for example when it is desired to create a dipole between the two distal and proximal ends of the capsule body. Such a dipole may in particular serves for the detection and/or the stimulation of the organ with which it is in contact.

[0063] The dielectric material of the tubular central part 60 is advantageously a ceramic, for example of the zirconia or alumina type.

[0064] Very preferentially, the chosen material is alumina rather than zirconia, although the latter is usually the material the most used in the particular applications considered herein (implants, in particular endocavitary cardiac implants).

[0065] Zirconia has indeed excellent mechanical properties, better that alumina, and that is the reason of its preferential choice in the state of the art, as disclosed in particular in above-mentioned WO 2004/002572 A1 and U.S. Pat. No. 7,771,838 B1.

[0066] However, very long term strength tests that have been performed have shown a risk of progressive degradation over time of these mechanical properties, due to a possible change of phase, under the only effect of ageing, of a tetragonal crystallographic structure into a monoclinic structure, which may be unstable: this evolution may introduce a progressive loss of the good initial mechanical properties of the material, which, in the worst case, could make it friable.

[0067] Due to the compelling need to preserve all the initial properties of the implant, including of course the mechanical robustness of its housing, over the whole expected life duration after implantation (i.e. for at least 10 years), this risk cannot be incurred in any way. That is why, in the case of the composite structure of the invention, the preferred dielectric material is alumina, in particular an alumina having a very high purity grade, higher than or equal to 99.5%.

[0068] The thickness of the dielectric material of the central tubular part 60 is typically 0.1 to 0.6 mm. The shape of the central tubular part 60 is preferably that of a through tube, open at its two ends.

[0069] As a variant, the part of the housing that is made of dielectric material could however be made as a blind tube, this dielectric part then continuing up to one of the ends of the envelope housing of the device.

[0070] For the metallic material of the lateral tubular parts 62, 64, titanium is advantageously chosen. The thickness of the titanium tube in these regions 62, 64 is typically of the order of 0.15 to 0.1 mm.

[0071] An essential characteristic common to the dielectric material of the central tubular part 60 and to the metallic material of the lateral tubular parts 62, 64 is that they are perfectly biocompatible and biostable. They hence do not need to be coated with a protective isolating layer, and may be in direct and permanent contact with body fluids, in particular with blood in the case of an implanted endocavitary capsule.

[0072] The tube 60 made of dielectric material and the tubes 62, 64 made of metallic material are sealed to each other through a brazing directly performed along the whole periphery of the regions in contact of the tubes respectively butted to each other.

[0073] Characteristically of the invention, this brazing is a planar brazing, i.e. the brazing is performed between the two end faces formed by the planar, annular edges of the two cylindrical parts located opposite to each other, the filler metal being brought between the two faces butted to each other.

[0074] In so far as the two tubes are not fit into each other, nor brought together with interposition of an intermediate part (as in the case of above-mentioned WO 2004/002572 A1) or of an intermediate layer of different nature (as in the case of above-mentioned U.S. Pat. No. 7,771,838 B1), it becomes possible to obtain a brazed, composite tube having in axial direction no discontinuity of its inner surface (i.e. the outer surface of the envelope tube of the device being accordingly uniform and having a constant diameter) and/or of its outer surface (i.e. the inner surface of the composite tube being accordingly uniform and having a constant diameter).

[0075] First, an external isodiametry of the composite tube provides an homogeneous and smooth outer surface over the whole length of the housing of the implant, providing the latter with an excellent surface atraumaticity. The metal/ceramic composite outer surface may from then on be kept as such (it will then be in direct contact with the body fluids and tissues), or possibly coated over all or part of its extent with a layer of a suitable coating material, for example parylene, a material used in particular for its hydrophobic and low friction coefficient properties.

[0076] Second, an internal isodiametry of the composite tube facilitates the mounting of the internal elements of the device, by allowing in particular the use of a multifunctional central part as the one described in copending application U.S. Ser. No. 16/393,924 of Apr. 24, 2019, assigned to the present applicant and incorporated herein by way of reference. This application discloses a tubular part made of plastic material, acting in particular as a support for the different components and mechanical and electrical sub-assemblies of the capsule: these elements are beforehand mounted and interconnected on the tubular support part, then the latter, so equipped, is inserted into the envelope tube of the capsule through an end opening, by simple axial translation over the whole length of the tube. The particular geometry of the support part and a suitable choice of the plastic material make it possible to provide self-centering during this operation and, at the end of the displacement, securing of the support part to the envelope tube with a tight fit.

[0077] The implementation of this specific support part and of the simplified assembly process thus allowed requires to be able to introduce it and to push it over the whole length of the envelope tube, which precisely is possible thanks to the internal isodiametry of the tube.

[0078] The brazing technique used is very preferentially a technique that only implements fully biocompatible materials. For the assembly of an alumina tube to a titanium tube, the process may for example comprise two successive steps, with a deposition of a metallization on the surface to be brazed on the alumina side by a metallic layer such as a titanium/niobium alloy, followed with a brazing of the two parts to each other with molten gold as a filler metal.

[0079] This way to proceed avoids the drawbacks of the technique disclosed by the above-mentioned WO 2004/002572 A1, in particular it avoids the use of a non-biocompatible metal (nickel) in the nickel-titanium alloy used for an active brazing, whereby the nickel-titanium alloy plays a double role of a primer metallization on the zirconia and of a filler metal between the two parts to be brazed.

[0080] The implemented brazing process parameters (temperature, operating mode, etc.) are per se conventional, they only need to be adapted to the geometry (planar and annular surfaces) and dimensions of the brazing interface. The techniques used and the respective advantages will depend in particular on the thicknesses of the tubes and on their respective conformation. In this respect, it will be noted that, due to the planar brazing between the butted surfaces of the dielectric tube 60 and of the metallic tube 62, the wall thickness of the tubes has a direct incidence on the brazing surface. Concretely, for the assembly to keep satisfying mechanical properties, it seems desirable to limit this thickness to a minimum wall value of 0.4 mm.

[0081] FIGS. 6a to 6f illustrate various tube configurations at the interface between the dielectric material tube 60 and the metallic material tube 62.

[0082] FIGS. 6a, 6b, 6e and 6f illustrate an example of assembly with an internal isodiametry, and FIGS. 6c, 6d and 6e an example of assembly with an external isodiametry.

[0083] To increase the surface of contact at the interface 66 between the two metallic and ceramic tubes, it may be advantageous to machine the metallic part 62 so as to form a flange 68 (FIGS. 6b and 6c) allowing making up for the thickness difference between the thinner, metallic tube, and the thicker, ceramic tube. In a reverse configuration, it is possible to provide a thicker metallic tube, machined with a counterbore 70 into which the ceramic tube 60 will be housed (FIG. 6f).

[0084] Advantageously, in the case of an external discontinuity between the two tubes (FIGS. 6a, 6b and 6f), a meniscus of glue 72 can be added to eliminate the sharp edge and increase the atraumaticity of the outer surfaces of the capsule.

[0085] In all these configurations, the brazing is performed at the planar interface 66 between the respectively butted contact regions. The presence of a flange or a shoulder is only intended essentially to make up for the different thicknesses or to facilitate a respective centering of the two tubes but essentially it does not participate to the brazing process.