HEADER FOR A MEDICAL IMPLANT DEVICE, PARTICULARLY FOR A PACEMAKER

Abstract

A header for a medical implant device is configured to provide an electrical connection to a circuit within the housing of the medical implant device. The header includes at least one circuit board; a header housing enclosing the circuit board and configured to be connected to the housing of the medical implant device; and a sensor system on the circuit board.

Claims

1. A header (1) for a medical implant device (2), the medical implant device (2) having a housing (4) with a device circuit (40) therein, wherein: a. the header (1) includes: (1) a header housing (10) configured to be connected to the housing (4) of the medical implant device (2), (2) a circuit board (20) enclosed within the header housing (10), the circuit board (20) having a sensor system (30) thereon, b. the header (1) is configured to provide an electrical connection between the circuit board (20) and the device circuit (40) of the medical implant device (2).

2. The header (1) of claim 1 wherein the sensor system (30) is configured to measure at least one of the following quantities: a. a quantity related to patient health status, b. blood glucose concentration, c. blood pressure, d. blood oxygen concentration, e. temperature, f. acceleration, g. patient posture, h. respiration, i. sound, j. magnetic field characteristics, k. electromagnetic field characteristics.

3. The header (1) of claim 1 further including at least one antenna (28): a. configured to receive or transmit signals, and b. provided on the circuit board (20).

4. The header (1) of claim 3 wherein the antenna (28) is defined by layers spaced at different locations across a thickness of the circuit board (20).

5. The header (1) of claim 1 further including a connector (50a, 50b): a. connected to the circuit board (20), and b. configured to electrically connect a lead to the circuit board (20).

6. The header (1) of claim 5 wherein the connector (50a, 50b) is defined by one of: a. a DF-4 connector (50b), b. an IS-4 connector, c. a DF-1 connector, and d. an IS-1 connector (50a).

7. The header (1) of claim 5 further including a connector contact member (51, 53) electrically connecting the connector (50a, 50b) to the circuit board (20).

8. The header (1) of claim 7 wherein the connector contact member (51, 53) extends from the circuit board (20) along a plane at least substantially parallel to or coincident with a board plane in which a major portion of the circuit board (20) is situated.

9. The header (1) of claim 8 wherein: a. an aperture (203) is defined within the circuit board (20), and b. the connector contact member (51) extends from the circuit board (20) across the aperture (203).

10. The header (1) of claim 8 wherein: a. the circuit board (20) is bounded by a board perimeter in the board plane, b. the connector contact member (53): (1) extends from the board perimeter, and (2) connects to the connector (50a) at a location spaced from the board perimeter.

11. The header (1) of claim 8 wherein the circuit board (20): a. extends along the board plane between opposing first and second board ends (21, 22), b. includes contact pads (27) situated at or adjacent the first board end (21), the contact pads (2) being electrically connected to the circuit board (20), c. the connector (50a) is connected to the circuit board (20) at or adjacent the second board end (22).

12. The header (1) of claim 11 wherein: a. an aperture (203) is defined within the circuit board (20) between the first and second board ends (21, 22), and b. a second connector (50b) is: (1) situated within or adjacent the aperture (203), and (2) connected to the circuit board (20)

13. The header (1) of claim 5 wherein the circuit board (20) has indicia defined on a discrete subsection of the circuit board (20), the indicia identifying a characteristic of the connector (50a, 50b).

14. The header (1) of claim 1 wherein the circuit board (20) includes an x-ray marker (26) configured to generate a defined contrast in an x-ray image of the header (1).

15. The header (1) of claim 1 wherein the circuit board (20) includes a filter configured to reduce electromagnetic interference in electrical signals traveling within the circuit board (20).

16. The header (1) of claim 1 further including a converter configured to convert MRI energy received by header (1) into photonic energy.

17. The header (1) of claim 1 wherein casted material (205) encapsulates the circuit board (20) within the header housing (10).

18. The header (1) of claim 1 further including a medical implant device (2) having a housing (4) with a device circuit (40) therein, wherein the header housing (10) is connected to the housing (4) of the medical implant device (2).

19. The header (1) of claim 16 wherein: a. the circuit board (20) has a header circuit (210) thereon configured to control the medical implant device (2), and b. the device circuit (40) in the housing (4) includes at least one of: (1) a battery configured to power stimulation pulses, and (2) a capacitor configured to generate stimulation pulses.

20. A combination medical implant device (2) and header (1) including: a. a medical implant device (2) having a housing (4) with a device circuit (40) therein, the device circuit (40) including at least one of: (1) a battery configured to power stimulation pulses, and (2) a capacitor configured to generate stimulation pulses, b. a header (1) for the medical implant device (2), the header (1) including: (1) a header housing (10) configured to connect to the housing (4) of the medical implant device (2), and (2) a circuit board (20) enclosed within the header housing (10), the circuit board (20) having a header circuit (210) thereon configured to control the device circuit (40) of the medical implant device (2), wherein the header (1) provides an electrical connection between the header circuit (210) and the device circuit (40) of the medical implant device (2) when the header housing (10) is connected to the housing (4) of the medical implant device (2).

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0040] In the accompanying drawings:

[0041] FIG. 1 shows an version of a header of a medical implant device in the form of a pace maker, wherein the header is connected to a housing of the medical implant device;

[0042] FIG. 2 shows the header according to FIG. 1 without its header housing;

[0043] FIG. 3 shows a circuit board of the header;

[0044] FIG. 4 shows a further illustration of the circuit board of FIG. 3;

[0045] FIG. 5 shows the header according to FIGS. 1 to 4 connected to a feedthrough assembly of the medical implant device;

[0046] FIG. 6 shows a further version of a header/medical implant device according to the invention, wherein the header is integrally formed with the housing of the medical implant device which optionally merely houses the energy source of the device;

[0047] FIG. 7 shows a close up of an version of a circuit board according to the invention with a multiple layer structure.

DETAILED DESCRIPTION OF EXEMPLARY VERSIONS OF THE INVENTION

[0048] FIGS. 1-5 shows a header 1 and a medical implant device 2 exemplifying the invention. The header 1 is configured to provide an electrical connection of at least one electrode 3 (FIG. 6) to a circuit 40 (which is not shown in detail) situated in a hermetically sealed housing 4 of the medical implant device 2. The header 1 includes at least one circuit board 20, and a preferably transparent and electrically insulating header housing 10 which encloses the circuit board 20 and is configured to be connected to the housing 4 of the medical implant device 2. A sensor system 30 (FIGS. 3-4) provided on the circuit board 20 is adapted to measure at least one of the following quantities: a quantity related to patient health status; blood glucose concentration; blood pressure; blood oxygen concentration; temperature; acceleration; patient posture; respiration; sound; and magnetic and/or electromagnetic field strength (or other field characteristics)

[0049] As seen in FIGS. 1-5, the circuit board 20 is flat, and is preferably formed as a circumferential frame defining a central aperture 203 (see particularly FIGS. 2-4). The circuit board 20 includes opposing first and second frame regions 21 and 22 integrally connected to each other by opposing third and fourth lateral frame regions 23, 24, with these frame regions surrounding the central aperture 203 of the circuit board 20. The circuit board 20 is preferably formed out of a low temperature cofired ceramics (LTCC) material.

[0050] FIG. 2 depicts two connection assemblies 50a, 50b that may form a pre-mounted or integrally formed connection assembly 50, and that provide (for example) a DF-4 connector 50b and an IS-1 connector 50a for connecting at least one electrode line. The circuit board 20 includes a corresponding number of connector contact members 51, 53 (FIGS. 2-5) in the form of elongated metal contact strips. To connect the circuit board 20 to the connection assembly (DF-4 connector) 50b, four of these connector contact members 51 extend from the first frame region 21 to the second frame region 22 across the aperture 203, and are welded, soldered, or otherwise connected to contacts 52 provided on the DF-4 connector 50b. The connector contact members 51 are attached to first and second frame regions 21, 22 of the circuit board 20 by means of projections 206 (FIG. 3) which hold the members 51 in place. To connect the circuit board 20 to the connection assembly (IS-1 connector) 50a, two further connector contact members 53 protrude from the second frame member 22 outwardly away from the central aperture 203, and are welded, soldered, or otherwise connected to corresponding contacts 54 (FIGS. 2, 5) of the IS-1 connector.

[0051] For fixing and/or positioning of the connector assembly 50 to the circuit board 20, the circuit board 20 includes a through-hole 204 (FIGS. 2-5) on the second frame region 22, which preferably includes a circular boundary section joined by a straight boundary section.

[0052] As seen in FIG. 5, the circuit board 20 includes an antenna 28 for receiving or transmitting signals. The antenna 28 extends in a meandering path around the central aperture 203 in multiple layers of the circuit board 20. FIG. 7 shows a close-up view of an exemplary version of the circuit board 20, showing the layer structure including three layers 71, 72 and 73. Shown is a first top layer 71, where an exemplary conductor trace is depicted. The deeper layers 72 and 73 are pointed out in FIG. 7 from on the side edge of circuit board 20.

[0053] Looking to FIG. 4, the circuit board includes indicia such as color and/or symbolic markers 29, 31 for identifying the aforementioned connectors 50a, 50b of the header 1. Here the symbolic markers are implemented as alphanumeric text 31, and the color markers are implemented as light-emitting diodes 29, wherein diodes in different colors can indicate different contact states of the connectors 50a, 50b. For example, a red diode might glow when an improper contact is detected, and a green diode might glow when a proper contact has been established.

[0054] As seen in FIGS. 2, 3 and 5, the circuit board preferably includes an x-ray marker 26 for generating a defined contrast in an x-ray image of the header 1.

[0055] The header 1 preferably includes a filter on the circuit board 20 for reducing electromagnetic interference. To further improve MRI compatibility of the medical implant device 2, the header's circuit board 20 preferably also includes a converter for converting energy induced by MRI into photonic energy. The circuit board 20/converter may include a diode array for this purpose. The filter and the converter may be located at any suitable place on the circuit board 20, or may be implemented as separate components. In FIGS. 3-4, the filter and the converter are included in the sensor system 30.

[0056] As shown in FIGS. 2, 3 and 5, the circuit board 20 preferably includes optical markers 25 for use in an automated mounting and/or welding process. Here, the markers can be used to determine the position and orientation of the circuit board 20.

[0057] To electrically connect the circuit board 20 to the circuit 40 of the medical implant device 2, the circuit board 20 preferably includes contact pads 27 (FIGS. 2-4), preferably on the first frame region 21. The contact pads 27 may be connected to the connector contact members 51, preferably via internal multi-layer or single layer wiring 207 (FIG. 3) within the circuit board 20. As seen in FIG. 2, the contact pads 27 may be welded or soldered to (e.g., straight) pins 61 of a feedthrough 60 of the hermetically sealed housing 4 of the medical implant device 2, wherein the pins 61 protrude out of the housing 2 and are aligned with the contact pads 27.

[0058] As an alternative way of connecting the circuit board 20 to the circuit 40 of the medical implant device 2 in housing 4, FIG. 5 shows a version that uses a feedthrough assembly 60 as described in U.S. Pat. No. 8,920,198. The feedthrough assembly 60 includes a carrier body 62 which bears an insulating body 63, e.g., with the insulating body 63 inserted within an opening of the carrier body 62, though the carrier body 62 and insulating body 63 could be integrally or differently formed. The carrier body 62, which may be connected to a wall of the housing 4 in a sealed fashion, has a top side facing the circuit board 20 and a bottom side facing away from the top side and the circuit board 20. The insulating body 63 can be formed of a ceramic material, or alternatively a plastic or other non-conductive material.

[0059] The insulating body 63 preferably extends through the carrier body 62, protrudes above and over the carrier body top side, and also preferably projects slightly beyond the bottom side to better electrically insulate the circuit board 20 from the medical implant device (not shown). However, the bottom of the insulating body 63 could instead be aligned with the bottom side of the carrier body 62, or could extend into the opening of the carrier body 62 by a distance less than the thickness of the carrier body 62. A positioning unit 68, shown in FIG. 5 as a pin, is oriented in a direction normal to the carrier body 62 and guided through an opening in the carrier body 62. The insulating body 63 includes receptacles arranged at regular intervals along the insulating body 63 for receiving contact bodies 65. The contact bodies 65 extend towards the contact pads 27 of the circuit board 20 through the carrier body 62 and the insulating body 63. Each contact body 65 includes a first limb 66 for contacting intermediate contact members 209 (e.g., metal strips) which are in turn welded, soldered, or otherwise attached to the contact pads 27 on the circuit board 20. Further, each contact body 66 includes an integrally-connected second limb 67, wherein the second limbs 67 are used to make contact with a circuit 40 (FIG. 1, e.g., a circuit board) in the housing 4 of the medical implant device 2.

[0060] FIG. 6 shows another version of the header 1 and medical implant device 2, wherein here an integrated circuit 210 that controls the medical implant device 2 is transferred into the header housing 10. The header housing 10 is integrally formed with the housing 4 of the medical implant device 2, which now merely houses a battery 40 for supplying the device 2 with electrical energy. The circuit board 20 of the header 1, which is embedded in the header housing 10 in a casted material 205 cast around the circuit board 20, may be connected to the battery 40 via contact pads and metal strips extending therefrom. The electrode 3 is integrated into the header housing 10 so that the electrode lines extend within the header housing 10. Such an arrangement can be used as a so-called leadless pacemaker and/or biomonitor.

[0061] The foregoing versions of the invention are exemplary, and are presented for purposes of illustration only. Alternative versions may include some or all of the features described herein. The invention is not limited to the foregoing versions, and rather is limited only by the claims set out below, with the invention encompassing all different versions that fall literally or equivalently within the scope of these claims.