Isolation / stiffening component with integrated X-ray detection for an active implant

Abstract

Arrangement (2) for an implantable medical device (1), comprising: - an electrically conductive structure (12), in particular in the form of an antenna, - a stiffening element (10) for stiffening the electrically conductive structure (12), wherein the stiffening element (10) is electrically insulating and is preferably an injection-molded part, and - an X-ray marker (11), in particular made of tungsten, which is connected to the stiffening element (10), wherein the X-ray marker (11) is preferably integrated into the stiffening element.

Description

[0001] The present invention relates to an arrangement for an implantable medical device, in particular for an active implantable medical device.

[0002] Implantable medical devices typically have an X-ray identifier, e.g. in the form of an X-ray marker, which produces a recognizable contrast on an X-ray image.

[0003] X-ray markers are used with implantable medical devices to ensure reliable detection and localization of the implant in X-ray imaging. Furthermore, X-ray markers can provide information about the implant, such as its type, orientation, or position, thereby facilitating identification and monitoring of the implant during and after implantation. In particular, information about the implant, such as the manufacturer, can be provided. A user (e.g., a physician) can then use this manufacturer information to select appropriate accessories for the implant, such as a compatible programmer.

[0004] In some known solutions, X-ray detection is integrated into the wiring or the electrically conductive structure. However, this only works with metals that are easily visible under X-rays, such as niobium.

[0005] If a change of material is desired, e.g. to unalloyed titanium (titanium group 4), the detectability of such integrated X-ray detection is no longer given.

[0006] In this regard, there are therefore approaches in the prior art to place an X-ray detection element made of tungsten inside the housing in an unshielded area or to weld it to an anchor in an outer area of ​​the implant header.

[0007] However, this presents the problem that there is usually no unshielded space in the aforementioned inner housing area. Furthermore, the variant where the tungsten X-ray detection element is welded to the outer armature has the disadvantage that it cannot be implemented in a semi-automated manufacturing process.

[0008] The present invention is based on the objective of providing an arrangement that makes it possible to efficiently enable X-ray detection in an implantable (especially active) medical device.

[0009] This problem is solved by an arrangement with the features of claim 1. Advantageous embodiments are described below.

[0010] According to claim 1, an arrangement for an implantable medical device (preferably for an active implantable medical device) is disclosed, comprising: - an electrically conductive structure, especially in the form of an antenna, - a stiffening element for stiffening the electrically conductive structure, wherein the stiffening element is electrically insulating and is preferably an injection-molded part, and - an X-ray marker, in particular made of tungsten, which is connected to the stiffening element, wherein the X-ray marker is preferably integrated into the stiffening element.

[0011] According to a preferred embodiment, the X-ray marker is overmolded by the material of the stiffening element and is at least partially, and in particular completely, surrounded by the material of the stiffening element.

[0012] According to another aspect of the invention, an implantable (in particular active) medical device is disclosed which has an arrangement according to the invention.

[0013] The arrangement is integrated, in particular, into a header of the device. An electrode lead, for example, can be connected to the device via the header. An active implantable medical device is defined as an implantable medical device whose intended function is powered by electrical energy from an electrical power source.

[0014] The implantable medical device may be one of the following: an implantable pacemaker, an implantable cardioverter-defibrillator, or a neurostimulator.

[0015] In the following, embodiments of the invention, as well as further features and advantages of the invention, will be explained with reference to the figures. The figures show: Fig. 1 a partial view of an implantable medical device with an embodiment of an arrangement according to the invention, and Fig. 2 a view of the arrangement according to Fig. 1.

[0016] Fig. Figure 1 shows an active implantable medical device 1, which has an arrangement 2 according to the invention, which is arranged in particular in a header 3 of the device 1. The header 3 serves in particular to connect an electrode lead to the device 1. The header 3 has a receiving device 4, which is designed to receive a connector of an electrode lead, and a contact socket 5, which is designed to receive and electrically contact the electrode lead connector, wherein the contact socket 5 is arranged in the receiving device 4 and has a plurality of electrical contact elements 55, in particular annular contact elements 55.

[0017] The arrangement 2 has an electrically conductive structure 12, which here functions as an antenna and can serve for communication between the device 1 and other devices, for example, an external patient device or an external programmer. The antenna is designed as a wire strip and is therefore stiffened or stabilized by a stiffening element. The stiffening element can also electrically isolate the antenna 12 from other components of the device 1, in particular from the contact socket 5 or the electrical contact elements 55 in the header 1. The stiffening element is preferably made of plastic and can, for example, be an injection-molded part.

[0018] To enable X-ray detection of the device 1, an X-ray marker 11, in particular made of tungsten, is connected to the stiffening element 10, wherein the X-ray marker 11 is preferably integrated into the stiffening element 10, in particular is at least partially or completely enclosed by the stiffening element 10, in particular by overmolding the X-ray marker 11 with the material of the stiffening element 10.

[0019] In particular, the invention can use an existing insulation / stabilization part 10 for the antenna 12 to integrate the X-ray detection therein.

[0020] By means of the arrangement of the X-ray marker 11 according to the invention, in particular by the overmolding, the X-ray detection is also isolated from the housing of the device 1 and from other conductors in the header 3. The tungsten material is very clearly visible in the X-ray image. If a stiffening part of the device already present for the antenna is used, the X-ray detection according to the invention does not require an additional component in the header.

[0021] The integrated X-ray detection is advantageously placed in a defined position both during the casting process and in the subsequent header, where there is no shielding by other header components.

Claims

[1] Arrangement (2) for an implantable medical device (1), comprising: - an electrically conductive structure (12), in particular in the form of an antenna, - a stiffening element (10) for stiffening the electrically conductive structure (12), wherein the stiffening element (10) is electrically insulating and is preferably an injection-molded part, and - an X-ray marker (11), in particular made of tungsten, which is connected to the stiffening element (10), wherein the X-ray marker (11) is preferably integrated into the stiffening element.

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