IMPLANTABLE MEDICAL DEVICE COMPRISING AN ENERGY STORAGE DEVICE

Abstract

An implantable medical device comprises a housing, a circuit board structure arranged within in the housing and comprising at least one flexible section, an electronic module comprising at least one electronic component arranged on the circuit board structure, and an energy storage device for providing electrical energy for operation of the implantable medical device. The energy storage device is a solid-state battery mounted on the circuit board structure. An energy generation device connected to the energy storage device is a secondary cell, wherein the energy generation device is configured to convert patient energy to electrical energy for charging the energy storage device.

Claims

1. An implantable medical device, comprising: a housing; a circuit board structure arranged within in the housing and comprising at least one flexible section; an electronic module comprising at least one electronic component arranged on the circuit board structure; and an energy storage device for providing electrical energy for operation of the implantable medical device; wherein the energy storage device is a solid-state battery mounted on the circuit board structure, wherein an energy generation device connected to the energy storage device being a secondary cell, wherein the energy generation device is configured to convert patient energy to electrical energy for charging the energy storage device.

2. The implantable medical device of claim 1, wherein the housing is hermetically sealed such that a chamber within the housing is sealed against an entry of fluid, and wherein the housing is hermetically sealed by a hermitically tight, biocompatible sealing layer.

3. The implantable medical device of claim 1, wherein the at least one electronic component and the energy storage device are mounted on the circuit board structure using the same mounting technology.

4. The implantable medical device of claim 1, wherein the at least one electronic component and the energy storage device are mounted on the circuit board structure as surface-mount devices using a surface-mount technology.

5. The implantable medical device of claim 1, wherein the energy storage device is a primary cell or a secondary cell.

6. The implantable medical device of claim 1, further comprising a coupling interface connected to the energy storage device being a secondary cell, wherein the coupling interface is configured to couple to an external device for wirelessly receiving electrical energy from the external device for charging the energy storage device.

7. The implantable medical device of claim 1, further comprising a further energy storage device for providing electrical energy for operation of the implantable medical device.

8. The implantable medical device of claim 1, wherein the housing has an oblong shape extending along a longitudinal axis, wherein the circuit board structure comprises a mounting plate extending along a plane oriented perpendicularly to the longitudinal axis, the energy storage device being fastened to the mounting plate.

9. The implantable medical device of claim 1, wherein the circuit board structure comprises at least two mounting plates extend along different planes.

10. The implantable medical device of claim 9, wherein the at least one flexible section connects two neighboring mounting plates with each other.

11. The implantable medical device of claim 9, wherein the circuit board structure forms a zig-zag shape in that a first mounting plate is connected via a first flexible section at a first side to a second mounting plate, and the second mounting plate is connected via a second flexible section at a second side opposite the first side to a third mounting plate.

12. A method for producing an implantable medical device, comprising: providing a housing; providing a circuit board structure to be received in the housing, the circuit board structure comprising at least one flexible section; providing an electronic module by mounting at least one electronic component on the circuit board structure; providing an energy storage device for providing electrical energy for operation of the implantable medical device; mounting the energy storage device, which is a solid-state battery, on the circuit board structure, and connecting an energy generation device to the energy storage device being a secondary cell, wherein the energy generation device is configured to convert patient energy to electrical energy for charging the energy storage device.

13. The method of claim 12, wherein the at least one electronic component and the energy storage device are mounted on the circuit board structure as surface-mount devices in a reflow process.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0041] Various features and advantages of the present invention may be more readily understood with reference to the following detailed description and the embodiments shown in the drawings. Herein,

[0042] FIG. 1 shows a schematic illustration of an implantable medical device;

[0043] FIG. 2 shows a view of an embodiment of an implantable medical device;

[0044] FIG. 3 shows a view of an embodiment of a folded circuit board; and

[0045] FIG. 4 shows a schematic drawing of an embodiment of an implantable medical device.

DETAILED DESCRIPTION

[0046] Subsequently, embodiments of the present invention shall be described in detail with reference to the drawings. In the drawings, like reference numerals shall designate functionally similar structural elements, if appropriate.

[0047] It is to be noted that the embodiments are not limiting for the present invention, but merely represent illustrative examples.

[0048] FIG. 1 shows a schematic illustration of an implantable medical device 1, for example, in the shape of an intra-cardiac pacing system (also denoted as implantable leadless pacemaker). The implantable medical device 1 comprises a housing 10 which encompasses an energy storage device 15, an electronic module 16, and a coupling interface 17. The housing 10 may comprise titanium or may be made of titanium.

[0049] As visible from FIG. 1, the housing 10 of the implantable medical device 1 has a generally oblong, for example, cylindrical shape extending along a longitudinal axis L.

[0050] At a distal end of the housing 10, a first electrode 13 (also called pacing electrode) is disposed. In a proximal region of the housing 10, a second electrode 11 (also called sensing electrode) is arranged. The second electrode 11 may be formed as a ring electrode.

[0051] The implantable medical device 1 may be fixed to cardiac tissue by a fixation device 12. The fixation device 12 may be formed by tines comprising Nitinol or being made of Nitinol. In one embodiment, four tines made of Nitinol may be formed at the distal end of the housing 10.

[0052] The energy storage device 15 is configured to provide electrical energy to the components of the implantable medical device 1, in particular to the electronic module 16, the coupling interface 17, and the electrode arrangement of the first electrode 13 and the second electrode 11.

[0053] The electronic module 16 may be configured to perform the functions of a pacemaker, including sensing cardiac events and providing pacing pulses. The electronic module 16 may comprise a processor and memory.

[0054] The coupling interface 17 may be configured for communication with an external device (e.g., a programmer wand). The coupling interface 17 may be configured to inductively couple to an external communication coil for providing for a communication.

[0055] In an implanted state, the implantable medical device 1, at its distal end, is placed on tissue, for example, cardiac tissue of a patient's heart, such that the tines of the fixation device 12 engage with the tissue and the electrode 13 comes to rest on tissue such that it electrically contacts with the tissue. By means of the electrode arrangement formed by the electrodes 11, 13, hence, electrical energy may be injected into the tissue for providing a stimulation, for example, a pacing action or a defibrillation.

[0056] Referring now to FIG. 2, an implantable medical device 1 in the shape of a leadless pacemaker comprises a housing 10, at a distal end of which a fixation device 12 having tines for fixing the device to cardiac tissue is arranged and an electrode 13 is disposed. The implantable medical device 1 may further comprise some or all components as described above in the context of FIG. 1.

[0057] Similarly to the embodiment of FIG. 1, in the embodiment of FIG. 2, the implantable medical device 1 has an oblong shape, the housing 10 of the implantable medical device 1 extending along a longitudinal axis L. The implantable medical device 1 may, for example, have the shape of a cylindrical capsule, the housing 10 having a length as measured along the longitudinal axis L substantially exceeding the diameter of the housing 10 as measured in a plane perpendicular to the longitudinal axis L.

[0058] In the embodiment of FIG. 2, the implantable medical device 1 comprises a circuit board structure 14 comprising a flex-circuit printed circuit board (PCB) folded into a zig-zag (“accordion”) shape, as illustrated in another view in FIG. 3. The circuit board structure 14 comprises multiple mounting plates 140A-140D which extend along parallel planes perpendicular to the longitudinal axis L and hence are offset with respect to each other along the longitudinal axis L. Neighboring mounting plates 140A-140D herein are connected to each other by flexible sections 141A-141C such that an interlinked circuit is board structure 14 is formed carrying electrical and electronic components of the implantable medical device 1.

[0059] Within the circuit board structure 14, the zig-zag shape is formed in that the mounting plates 140A-140D are connected to each other by means of the flexible sections 141A-141C in an alternating fashion at diametrically opposite sides with respect to the longitudinal axis L. In particular, a first mounting plate 140A carrying components 160 of an electronic module 16 is connected to a neighboring, second mounting plate 140B by means of a flexible section 141A on a first side of the longitudinal axis L, as this is visible in FIG. 3. The mounting plate 140B is connected to a neighboring, third mounting plate 140C by means of an flexible section 141B, the flexible section 141B being formed at a side diametrically opposite, with respect to the longitudinal axis L, to the flexible section 141A. The mounting plate 140C in turn by means of a flexible section 141C is connected to another, fourth mounting plate 140D, the flexible section 141C again being located at a side of the longitudinal axis L diametrically opposite to the flexible section 141B, as visible from FIG. 3.

[0060] The flexible sections 141A-141C may be formed by so-called flex-bands mechanically interconnecting the mounting plates 140A-140D. Conduction paths herein may be formed on the flexible sections 141A-141C such that via the flexible sections 141A-141C also an electrical interconnection in between the mounting plates 140A-140D is established.

[0061] The mounting plates 140A-140D each have a substantially circular shape, when viewed in an associated plane perpendicular to the longitudinal axis L of the implantable medical device 1. The circuit board structure 14 herein is received within a chamber 100 formed by the housing 10 and confined by an inner, cylindrical wall 101 surrounding the chamber 100. The shape of each mounting plate 140A-140D substantially conforms to the circular cross-sectional shape of the chamber 100, such that the circuit board structure 14 is arranged within the housing 10 in a space-efficient manner.

[0062] Because multiple mounting plates 140A-140D are stacked and displaced with respect to each other along the longitudinal axis L, electrical and electronic components may be arranged within the housing 10 in a space-efficient, stacked manner, allowing to design a compact implantable medical device 1 having reduced space requirements and an increased packing density.

[0063] Electronic components 160 received on the mounting plate 140A may, for example, comprise a processor and a memory, for example, in the shape of integrated circuits (ICs).

[0064] The implantable medical device 1 comprises an energy storage device 15 in the shape of a solid-state battery arranged on the mounting plate 140C, the energy storage device 15 being mechanically connected and electrically contacted to the mounting plate 140C. The energy storage device 15 herein, in the embodiment of FIGS. 2 and 3, is received in between two neighboring mounting plates 140C, 140D.

[0065] By providing an energy storage device 15 in the shape of a solid-state battery, which together with electronic components 160 is arranged on the circuit board structure 14, an easy assembly of the implantable medical device 1 may be achieved, in that the energy storage device 15 and the electronic module 16 form a combined module which may be placed as such in the housing 10, hence avoiding the need for a separate assembly of an energy storage device 15 in the shape of a battery in the housing 10. In addition, because the energy storage device 15 is arranged on the circuit board structure 14 and hence is electrically connected to the conduction paths of the circuit board structure 14 and via the conduction paths to the circuitry of the electronic module 16, no need for an additional electrical connection in between a (separate) energy storage device and the electronic module 16 is required, hence facilitating production of the medical device 1.

[0066] A solid-state battery employs a battery technology that uses solid electrodes and a solid electrolyte. Materials useable as solid electrolytes in solid-state batteries may, for example, include ceramics (e.g., oxides, sulfides or phosphates), and solid polymers.

[0067] By receiving the energy storage device 15 in between mounting plates 140C, 140D, which are interlinked by a flexible section 141C, the energy storage device 15 is arranged within the housing 10 in a space-efficient manner.

[0068] Referring now to FIG. 4, an electronic module 16 may comprise multiple electronic components 160, including, for example, processor devices and memory devices. The electronic components 160 are placed on a circuit board structure 14, which at least partially is flexible such that it may be flexibly deformed for placing it within the housing 10 of the implantable medical devices 1 during assembly.

[0069] Together with the electronic components 160, an energy storage device 15 in the shape of a solid-state battery is placed on the circuit board structure 14, the electronic components 160 and the energy storage device 15 being mounted to the circuit board structure 14, for example, using the same mounting technology, in particular a surface-mount technology (SMT), such that the electronic components 160 as well as the energy storage device 15 are surface-mount devices (SMD).

[0070] For manufacturing the electronic module 16, the electronic components 160 as well as the energy storage device 15 is placed on the circuit board structure 14, wherein soldering connections in between the circuit board structure 14 and electronic components 160, respectively, the energy storage device 15 are established in a common process, such as a common reflow process by placing the circuit board structure 14 with the electronic components 160 and the energy storage device 15 arranged thereon in a reflow soldering oven in order to establish soldering connections using a reflow process.

[0071] The energy storage device 15 in the shape of the solid-state battery, as shown in FIG. 4, may, in particular, be a secondary cell, which is rechargeable. A recharging herein, for example, may take place by means of a coupling interface 17, which, for example, is configured to inductively couple to an external device 2. Hence, using the coupling interface 17, a recharging of the energy storage device 15 may be achieved in an implanted state of the medical device 1 by coupling the external device 2, which is placed outside of the patient, inductively to the coupling interface 17 and to in this way transfer electrical energy towards the medical device 1 for recharging the energy storage device 15.

[0072] Alternatively or in addition, the medical device 1 may comprise an energy generation device 18, which is configured to convert patient energy, i.e., energy originating from the patient, to electrical energy for charging the energy storage device 15. The energy generation device 18 may, for example, convert kinetic energy stemming from the patient, for example, flow energy of a blood flow or kinetic energy of the patient's heart, to electrical energy and may feed a current generated in this way to the energy storage device 15.

[0073] The energy generation device 18 may, for example, comprise a movable element which may be moved by a blood flow or by cardiac movement.

[0074] Alternatively or in addition, the energy generation device 18 may, for example, comprise an arrangement of piezo elements which may convert mechanic energy to electrical energy.

[0075] In one embodiment, the medical device 1 comprises an additional, further energy storage device 19, which may be a solid-state battery or another type of battery, such as a lithium-based battery. The additional, further energy storage device 19 may be placed on the circuit board structure 14 or may be separate from the circuit board structure 14. The further energy storage device 19 may be a non-rechargeable primary cell or a rechargeable secondary cell and may, in particular, supplement an energy supply for operation of the medical device 1.

[0076] In one embodiment, the housing 10 of the medical device 1 is hermetically sealed by a sealing layer 102, formed, for example, from a polymer coating material, such as a parylene coating. By means of the sealing layer 102, the housing 10 is enclosed and hence sealed towards the outside, such that no fluid may enter into the housing 10. Due to the coating by the sealing layer 102, requirements for a biocompatibility of the housing 10 itself, in particular the material of the housing 10, and for a fluid tightness of the housing 10 itself may be reduced.

[0077] By using a solid-state battery as an energy storage device in combination with a flexible circuit board, a miniaturization of a medical device becomes possible, which, in particular, allows a design of small-sized stimulation devices or sensing devices, such as a leadless pacemaker device or an implantable sensor, for example, in implantable pressure sensor.

[0078] It will be apparent to those skilled in the art that numerous modifications and variations of the described examples and embodiments are possible in light of the above teachings of the disclosure. The disclosed examples and embodiments are presented for purposes of illustration only. Other alternate embodiments may include some or all of the features disclosed herein. Therefore, it is the intent to cover all such modifications and alternate embodiments as may come within the true scope of this invention, which is to be given the full breadth thereof. Additionally, the disclosure of a range of values is a disclosure of every numerical value within that range, including the end points.

LIST OF REFERENCE NUMERALS

[0079] 1 Implantable medical device (pacemaker device) [0080] 10 Housing [0081] 100 Chamber [0082] 101 Inner wall [0083] 102 Sealing layer [0084] 11 Electrode [0085] 12 Fixation device [0086] 13 Electrode [0087] 14 Circuit board structure [0088] 140A-140D Mounting plate [0089] 141A-141C Flexible section [0090] 15 Energy storage device [0091] 16 Electronic module [0092] 160 Electronic components [0093] 17 Coupling interface [0094] 18 Energy generation device [0095] 19 Further energy storage device [0096] 2 External device [0097] B Body [0098] C Chest [0099] D Height [0100] L Longitudinal axis [0101] M Magnetic field [0102] R Back [0103] T Transverse direction [0104] W Width