DE202023106883U1 - Implantable medical device - Google Patents

Abstract

Implantable medical device (1), in particular in the form of a pacemaker, for electrical stimulation of tissue and/or for measuring signals, (1), comprising: - an electrode body (2) with at least one electrode contact (20, 21) and a plug connector (23) at a proximal end (2b) of the electrode body (2), and - an active implant (3) having a circuit (30) for generating the electrical stimulation and/or for measuring signals and a battery (31) for supplying energy of the circuit (30), wherein the active implant (3) has a non-metallic housing (32) which extends along a longitudinal axis (x) and which encloses the circuit (30) and the battery (31), on the housing (32) a plug connector (33) is arranged for plug connection with the plug connector (23) of the electrode body (2), and wherein the housing (32) - based on a state in which the active implant (3) via the plug connector ( 33, 23) is connected to the electrode body (2) - has a cross-sectional area (Q2) perpendicular to the longitudinal axis (x), which is not more than 50% larger than a cross-sectional area (Q1) of the electrode line (2) perpendicular to the longitudinal axis (x ).

Description

The present invention relates to an implantable medical device, in particular a pacemaker (e.g. cardiac pacemaker) or a monitoring device.

Pacemakers are known from the prior art, which allow the connection of electrode lines via a plug-in connection via a header which is applied to a comparatively large titanium housing of the pacemaker.

Furthermore, relatively small intracardiac pacemakers are known which do not have a separate electrode line, but rather an electrode integrated into the pacemaker housing. Such pacemakers are therefore also referred to as “leadless pacemakers”.

Known leadless pacemaker solutions are currently only suitable for single-chamber pacing cases. Furthermore, both implantation (e.g. perforation of the aorta) and explantation pose a challenge with corresponding risk potential. In addition to the metal housing, a non-metal area is needed to accommodate the antenna. The aforementioned classic pacemaker uses a metal housing with a header and additional electrodes. For the implantation of the metal housing including the header, a correspondingly large incision is required in the patient's chest area. The pacemaker can be felt; due to the large area, there is a certain risk of inflammation of the pocket. Replacing the classic pacemaker requires a correspondingly large incision in the chest area. The Leadless Pacemaker features a design intended solely for cardiac stimulation.

Based on this, the present invention is based on the object of providing an implantable medical device or system, in particular in the form of a pacemaker and at least one associated electrode body, which combines the advantages of the devices mentioned at the outset.

This object is achieved by an implantable medical device for electrical stimulation of tissue and/or for measuring signals according to claim 1. Advantageous embodiments and further aspects of the invention are described herein.

• - einen Elektrodenkörper mit zumindest einem Elektrodenkontakt sowie einem Steckverbinder an einem proximalen Ende des Elektrodenkörpers, und
• - ein aktives Implantat aufweisend einen Schaltkreis zur Erzeugung der elektrischen Stimulation und/oder zur Messung von Signalen sowie eine Batterie zur Energieversorgung des Schaltkreises, wobei das aktive Implantat ein nicht-metallisches Gehäuse aufweist, das sich entlang einer Längsachse erstreckt und das den Schaltkreis und die Batterie umschließt, wobei am Gehäuse (insbesondere an einem Ende des Gehäuses) ein Steckverbinder angeordnet ist zur Steckverbindung mit dem Steckverbinder des Elektrodenkörpers, wobei das Gehäuse - bezogen auf einen Zustand, in dem das Gehäuse über die Steckverbinder mit dem Elektrodenkörper bestimmungsgemäß verbunden ist - eine Querschnittsfläche senkrecht zur Längsachse aufweist, die nicht mehr als 50% größer ist als eine senkrecht zur Längsachse erstreckte Querschnittsfläche des Elektrodenkörpers.

According to claim 1, the implantable medical device has:

• - an electrode body with at least one electrode contact and a plug connector at a proximal end of the electrode body, and
• - an active implant comprising a circuit for generating the electrical stimulation and/or for measuring signals and a battery for supplying energy to the circuit, the active implant having a non-metallic housing which extends along a longitudinal axis and which contains the circuit and the Battery encloses, a plug connector being arranged on the housing (in particular at one end of the housing) for plug connection to the plug connector of the electrode body, the housing - based on a state in which the housing is properly connected to the electrode body via the plug connectors - a Has a cross-sectional area perpendicular to the longitudinal axis, which is no more than 50% larger than a cross-sectional area of the electrode body extending perpendicular to the longitudinal axis.

According to one embodiment of the invention, said cross-sectional area of the housing is not more than 30% larger than said cross-sectional area of the electrode body, preferably not more than 20%, preferably not more than 10%, preferably not more than 5%. In particular, the cross-sectional area of the housing is smaller or equal to the cross-sectional area of the electrode body.

In particular, said cross-sectional area of the electrode body is the maximum cross-sectional area perpendicular to a longitudinal axis of the electrode body or insertion direction of the plug connector. Furthermore, said cross-sectional area of the housing of the active implant is the maximum cross-sectional area of the active implant or housing perpendicular to the longitudinal axis of the housing.

According to one embodiment, the device is a pacemaker, in particular a cardiac pacemaker. The electrode body can then be designed as an elongated flexible electrode line which extends along the longitudinal axis of the housing when the electrode line is connected to the housing via the connectors on both sides. The electrode line can have the at least one electrode contact at a distal end section of the electrode line (i.e. away from the housing). Furthermore, the active implant in this embodiment forms a pulse generator for generating electrical pulses.

The solution according to the invention therefore represents a comparatively small step maker ready, which has the advantages of the currently existing electrode leads and, in combination with other active implants or pulse generators, allows two- and three-chamber pacing without having to implant a “large” device or classic pacemaker (see above). . Furthermore, the invention enables an exchange of the active implant that can be implanted outside the heart (without simultaneous explantation of the electrode lead). In particular, the device can have a transparent or non-metallic housing and can therefore integrate components (antenna, sensors (especially light-sensitive ones), RFID chip). If a classic pacemaker is replaced, the operation is minimally invasive and takes place at the same time as the electrode lead is inserted.

The replacement of the device is particularly minimally invasive. Furthermore, body data in particular can be recorded by built-in sensors. The invention also extends to devices capable of stimulating other areas (brain, bladder, nerves) and are relatively small.

According to a particularly preferred embodiment of the invention, said cross-sectional area of the housing is less than or equal to said cross-sectional area of the electrode line. The diameter of the attached pacemaker is therefore particularly preferably only slightly larger or equal to the diameter of the electrode line. The pacemaker is, so to speak, part of the electrode line or the electrode body. This geometry can also be used to advantageously implement a monitoring device for measuring signals/body functions of a patient.

Accordingly, according to a further embodiment, it is provided that the electrode body is not a longitudinally extended flexible electrode line, but rather a rigid (pluggable) electrode body which, in particular in the direction of the longitudinal axis, has a length which is smaller than the length of the housing of the active implant in the direction of the longitudinal axis. In this embodiment it is further provided that the housing has a further electrode contact at an end that is opposite the electrode body when it is connected to the housing as intended.

According to one embodiment of the invention it is further provided that the active implant has an antenna. The antenna can be set up and provided for communication with an external device (e.g. for programming the active implant), in particular via RF communication in the MICS band. Furthermore, the antenna or another antenna, in particular an RFID chip, can be provided for communication of the active implant (in particular pulse generator) with another active implant (in particular pulse generator). In this way, a system can be set up for two- or three-chamber stimulation of a patient's heart. The two or three pulse generators can then communicate with each other via their antennas or RFID chips in order to synchronize the stimulations accordingly.

According to a further aspect of the invention, a system is disclosed, comprising at least two (or three) devices according to the invention with electrode lines and active implants (pulse generators), each active implant having an antenna/device arranged in the housing of the implant in order to communicate with the other active ones communicate with implants.

• 1 eine schematische Darstellung einer Ausführungsform eines erfindungsgemäßen implantierbaren medizinischen Geräts mit flexibler Elektrodenleitung und aktivem Implantat;
• 2 eine schematische Darstellung des aktiven Implantats gemäß 1,
• 3 eine weitere schematische Darstellung einer Ausführungsform eines erfindungsgemäßen implantierbaren medizinischen Geräts,
• 4 eine schematische Darstellung einer Ausführungsform eines erfindungsgemäßen Systems aufweisend mehrere erfindungsgemäße implantierbare medizinischen Geräte zur Mehrkammer-Stimulation eines Herzens, und
• 5 eine Ausführungsform eines erfindungsgemäßen medizinischen Geräts in Form eines Monitoring-Geräts.

Embodiments as well as further features and advantages of the invention will be explained below with reference to the figures. Show it:

• 1 a schematic representation of an embodiment of an implantable medical device according to the invention with a flexible electrode line and active implant;
• 2 a schematic representation of the active implant according to 1 ,
• 3 a further schematic representation of an embodiment of an implantable medical device according to the invention,
• 4 a schematic representation of an embodiment of a system according to the invention having several implantable medical devices according to the invention for multi-chamber stimulation of a heart, and
• 5 an embodiment of a medical device according to the invention in the form of a monitoring device.

1 shows in connection with 2 a schematic representation of an embodiment of an implantable medical device 1 according to the invention for electrical stimulation of tissue, here for example in the form of a pacemaker.

The device 1 points accordingly 3 a flexible electrode line 2 that extends or can be arranged longitudinally along a longitudinal axis cross-section surface Q1 perpendicular to the longitudinal axis x. Furthermore, the device 1 has an implantable active implant 3, with a circuit 30 for generating the electrical stimulation or pulses and with at least one or more batteries 31 for supplying energy to the circuit 30, the respective battery 31 being able to be charged via a coil 36 . Furthermore, the active implant 3 has a non-metallic, in particular transparent, housing 32, which encloses the circuit 30 and the at least one battery 31, a plug connector 33 being arranged on the housing 32 for plug connection to the plug connector 23 of the electrode line 2, wherein the housing 32 - based on a state in which the housing 32 is electrically conductively connected to the electrode line 2 via the plug connectors 23, 33 as intended (cf. 1 or 3 ) - has a cross-sectional area Q2 perpendicular to the longitudinal axis x of the electrode line 2 or the housing 32, which is not more than 50%, preferably not more than 30%, preferably not more than 20%, preferably not more than 10%, preferably not more is greater than 5% than the cross-sectional area Q1 of the electrode line 2 perpendicular to the longitudinal axis x. Particularly preferably, said cross section Q2 of the housing 32 is smaller or equal to the cross section Q1 of the electrode line 2.

The device 1 or the active implant 3 has in particular one or more narrow batteries 31 and a particularly folded circuit 30. The housing 32 preferably consists of a transparent biocompatible material such as a resin, silicone, glass, ceramic, TPU, PSU or PMMA. An antenna 34, an RFID chip 35, a coil 36 and at least one sensor 37 can optionally and in any combination be integrated into this particularly transparent housing 32. In order to achieve the required battery capacity without achieving a significantly larger diameter than the electrode line 2, narrow, cylindrical batteries 31 can be used and, if necessary, connected in series. The hybrid circuit 30 is preferably shielded to prevent interference radiation. For this purpose, a cap can be placed around the hybrid circuit 30.

4 shows the use of the implant 3 according to 1 in a system for three-chamber stimulation of the heart (two-chamber stimulation can also be achieved by using only two electrode lines 2 and two active implants/pulse generators 3), the active implants 3 having corresponding devices (e.g. RFID 35) of the active implants 3 to be able to communicate with each other.

The present invention advantageously allows the provision of extremely small, minimally invasively replaceable, possibly rechargeable pacemakers, which are integrated into the electrode or correspond to its cross-sectional dimension. This simplifies implantation and reduces the likelihood of inflammation. At the same time, the wearing comfort for the implant recipient improves. Furthermore, the pacemaker no longer needs a header, which previously housed the feedthrough, external wiring, antenna and the electrode plug-in area. The non-metallic and in particular transparent housing 32 allows the antenna 34, RFID chip 35 and sensors 37 to be attached therein. The external wiring is not even needed. Such pacemakers can still be used in combination for two- and three-chamber pacing (cf. 2 ), in that the active implants 3 communicate with each other (for example by using RFID technology). The device 1 can also be reconfigured into a monitoring device without a long electrode line 2 with, in particular, two additional components.

The 5 shows a corresponding embodiment. Here, instead of the long electrode line, 2 is used 3 a short rigid electrode body 2 is provided, which can be connected to the active implant 3 via the plug connectors 23, 33 on both sides. The active implant 3 has a further electrode contact 22 at the opposite end.

Furthermore, the device according to the invention can also be used for other stimulation purposes (brain, bladder, nerves) because its small size means it can be placed there in an advantageous manner.

Claims (1)

Implantable medical device (1), in particular in the form of a pacemaker, for electrical stimulation of tissue and/or for measuring signals, (1), comprising: - an electrode body (2) with at least one electrode contact (20, 21) and a plug connector (23) at a proximal end (2b) of the electrode body (2), and - an active implant (3) having a circuit (30) for generating the electrical stimulation and/or for measuring signals and a battery (31) for supplying energy of the circuit (30), wherein the active implant (3) has a non-metallic housing (32) which extends along a longitudinal axis (x) and which encloses the circuit (30) and the battery (31), on the housing (32) a plug connector (33) is arranged for plug connection with the plug connector (23) of the electrode body (2), and wherein the housing (32) - based on a State in which the active implant (3) is connected to the electrode body (2) via the connectors (33, 23) - has a cross-sectional area (Q2) perpendicular to the longitudinal axis (x), which is no more than 50% larger than one Cross-sectional area (Q1) of the electrode line (2) perpendicular to the longitudinal axis (x).

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