Feedthrough Of A Medical Electronic Device, Method For Producing Same, And Medical Electronic Device

Abstract

A feedthrough of a medical electronic device, which in particular is implantable and has a device housing in which electronic and/or electrical function units are housed and which has a housing opening closed by the feedthrough, wherein the feedthrough has an insulating body, a feedthrough flange surrounding the insulating body and fixed to the housing opening, and at least one connection element penetrating through the insulating body for the external connection of at least one component of the device, wherein the connection element or at least one connection element consists at least in part, in particular substantially fully, of a shape-memory alloy.

Claims

1. A feedthrough of a medical electronic device, which is implantable and has a device housing in which electronic and/or electrical function units are housed and which has a housing opening closed by the feedthrough, wherein the feedthrough has an insulating body, a feedthrough flange surrounding the insulating body and fixed to the housing opening, and at least one connection element penetrating through the insulating body for the external connection of at least one component of the device, wherein the connection element or at least one connection element consists at least in part, in particular substantially fully, of a shape-memory alloy.

2. The feedthrough according to claim 1, wherein the connection element or at least one connection element consists at least in part of a shape-memory alloy demonstrating a one-way shape-memory effect.

3. The feedthrough according to claim 1, wherein the connection element or at least one connection element consists at least in part of a shape-memory alloy demonstrating a two-way shape-memory effect.

4. The feedthrough according to claim 1, wherein the connection element or at least one connection element is joined from at least two parts and at least one of the parts consists fully of a shape-memory alloy.

5. The feedthrough according to claim 4, wherein the connection element or at least one connection element has an outer tube and a core, and the core consists of a shape-memory alloy.

6. The feedthrough according to claim 1, wherein the connection element or at least one connection element consisting fully of a shape-memory alloy has a thin coating, or a portion of the connection element or at least one connection element consisting of a shape-memory alloy has a thin coating.

7. The feedthrough according to claim 1, wherein the shape-memory alloy or at least one shape-memory alloy has super-elastic properties in order to form a connection element or part thereof.

8. The feedthrough according to claim 1, which has a grounding pin, which is formed at least in part from a shape-memory alloy, in particular one that demonstrates super-elastic behavior.

9. A medical electronic device having a feedthrough according to claim 1, in particular formed as a cardiac pacemaker, implantable cardioverter or cochlear implant.

10. A method for producing a device according to claim 9, wherein the finished, assembled feedthrough is heated prior to the assembly of the device to a temperature above the characteristic phase-transition temperature of the shape-memory alloy, in particular in a climatic chamber or by resistance heating or via thermal conduction from an applied heating element.

11. The method according to claim 10, wherein a grounding pin in thermal contact with the feedthrough flange is heated by inductive heating of the feedthrough flange.

12. A plug part of a medical electronic modular unit, which has an insulating body and at least one connection element penetrating through the insulating body for the external connection of an electrical line of the modular unit, wherein the connection element or at least one connection element consists at least in part, in particular substantially fully, of a shape-memory alloy.

13. The plug part according to claim 12, wherein the connection element or at least one connection element consists at least in part of a shape-memory alloy demonstrating a one-way shape-memory effect or demonstrating a two-way shape-memory effect, and/or the connection element or at least one connection element is joined from at least two parts and at least one of the parts consists fully of a shape-memory alloy.

14. A medical electronic modular unit having a plug part according to claim 12, in particular formed as an implantable electrode line.

15. A method for producing a modular unit according to claim 14, wherein the finished plug part is heated prior to the assembly of the modular unit to a temperature above the characteristic phase-transition temperature of the shape-memory alloy, in particular in a climatic chamber or by resistance heating or via thermal conduction from an applied heating element.

Description

DESCRIPTION OF THE DRAWINGS

[0035] Advantages and expedient features of the present invention will become clear incidentally from the description of exemplary embodiments with reference to the drawings, in which:

[0036] FIG. 1 shows a schematic, partly cut-away illustration of an implantable medical electronic device,

[0037] FIG. 2 shows a schematic illustration (sectional view) of a feedthrough flange of conventional design,

[0038] FIGS. 3A-3C show sketched illustrations in order to explain a first variant of the present invention,

[0039] FIGS. 4A-4D show sketched illustrations in order to explain a second variant of the present invention,

[0040] FIG. 5 shows a schematic perspective view of an embodiment of the plug part according to the present invention, and

[0041] FIG. 6 shows a schematic longitudinal sectional view of an embodiment of a feedthrough according to the present invention.

DETAILED DESCRIPTION

[0042] FIG. 1 shows a cardiac pacemaker 1 having a pacemaker housing 3 and a head part (header) 5, in the interior of which there is arranged a printed circuit board (PCB) 7 in addition to other electronic components, there also being an electrode line 9 connected to the line connection (not shown) arranged in the header 5 of said pacemaker 1. A feedthrough 11 provided between the device housing 3 and header 5 comprises a multiplicity of connection pins 13. The connection pins 13 are plugged at one end through a corresponding bore in the printed circuit board 7 and are soft-soldered thereto. The soldering can be performed at a soldering temperature of 230 C., for example.

[0043] FIG. 2 shows, in a sectional illustration along a central plane of section, a feedthrough 11 of conventional design, which comprises a ceramic insulating body 11a' and a feedthrough flange 11b milled from solid material, which surrounds the insulating body 11a. A solder ring 11c is placed in a recess, annularly surrounding the insulating body 11a, at the lower end of the feedthrough flange 11b; the insulating body 11a is connected there to the feedthrough flange in a hermetically sealed manner by means of a hard-soldering method. Long and short connection pins 13a, 13b penetrate through the insulating body 11a, and a grounding pin 13c is welded on outside to the feedthrough flange 15. A peripheral flange edge at the feedthrough flange 15 serves as a welding edge when the flange is inserted into a clearance or bore of a device housing (not shown) and is welded there.

[0044] FIGS. 3A-3C and 4A-4D each show, in a sketched manner, various states of a cylindrical pin serving as connection element and made of a shape-memory alloy (for example NiTi or nitinol, NiTiCu, CuZnAl, CuAlNi, FeMnSi, FeNiCoTi), which can be used in a feedthrough or a plug part designed in accordance with the present invention. The illustrations serves to show the form or dimensional changes and mechanical behavior of said pin, irrespective of the specific installation situation in a feedthrough or a plug part and without consideration of influences of the installation situation on the dimensional changes and mechanical behavior.

[0045] In FIG. 3A, the pin is in the delivered state and is processed for a feedthrough. During the joining process, the originally set temperature of the shape-memory wire is shifted upwardly by a few degrees. As symbolized in FIG. 3B, the soldered pin may be damaged on account of bending or deformation. The feedthrough with pin will be classed as a rejection at the time of inspection of the observance of position/form tolerances, since the contact element does not meet the specifications and cannot be reliably connected to the contacts in the subsequent processes.

[0046] As symbolized in FIG. 3C, the deformed pin can be returned to its original form by heating by use of the one-way shape-memory effect, and therefore the position of its end to be connected lying within the tolerance range can be re-established. The heat treatment is performed in a convection oven or in a climatic chamber. It is advantageous to couple the heat treatment with a subsequent process (heat treatment by pre-heating in a reflow process, plasma cleaning or plasma activation prior to the further processing).

[0047] FIG. 4A also shows the pin in the delivered state, as it can be processed for a feedthrough or a plug part. The modified form/end face position of the pin is trained into the material in accordance with FIG. 4B (heat treatment). The pin is then deformed for assembly and is inserted into the feedthrough or the plug part in the state shown in FIG. 4C. A joining process is then performed, for example, at approximately 800 C. During the joining, the originally set temperature of the shape-memory wire is shifted upwardly by a few degrees.

[0048] As a result of the two-way shape-memory effect, the pin transfers, as it cools, into the defined form/position previously trained. The trained dimensional change can be used repeatedly to retrieve pins from equipping devices. Once demolded, the pins are transferred into their end form by means of a heat-treatment process.

[0049] FIG. 5 shows a perspective view of a plug part 11, for example, as a component of an electrode line, which comprises an insulating body 11a, a plug flange 11b surrounding the insulating body, and a connection pin 13 penetrating through the insulating body centrally and made of a shape-memory alloy.

[0050] FIG. 6, in a schematic longitudinal sectional illustration, shows a feedthrough 11 which comprises an insulating body 11a, a feedthrough flange 11b surrounding the insulating body 11a, and a connection pin 13 penetrating through the insulating body 11a centrally. The connection pin 13 is constructed in two parts from a core 13.1 made of a shape-memory alloy and an outer tube 13.2 made of a conventional conductive metal.

[0051] The present invention can also be carried out in a large number of modifications of the examples presented here and aspects of the present invention detailed further above.

[0052] 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.

[0053] Additionally, the disclosure of a range of values is a disclosure of every numerical value within that range.