Implant packaging, packaging system for a medical implant, and method for packaging a medical implant comprising a contact element for testing the function of an electrode in the packaged state

Abstract

The invention relates to a packaging body for a medical implant, in particular a pacemaker and / or a neurostimulator, having a housing and a wire electrode connected to the housing, having a contact electrode arranged in a distal end region of the wire electrode, comprising packaging material which comprises closure means running along a sealing contour of the packaging material, wherein at least part of the packaging material and the closure means delimit a sterile and / or sterilisable interior of the packaging body, in which the implant is accommodated in a sterilely packaged state, wherein the packaging body, in particular in the interior, comprises electrically conductive contact means which are arranged such that, in the sterilely packaged state, the contact electrode of the implant, which is spaced apart from the housing of the implant by the wire electrode and is simultaneously electrically, and preferably mechanically, connected to the implant via the wire electrode, comes into contact, or can be brought into contact, with the contact means.

Description

[0001] POV-P-04608-WP2 - 1 - 04 / 02 / 2025

[0002] Implant packaging, packaging system for a medical implant and method for packaging a medical implant comprising a contact element for functional testing of an electrode in the packaged state

[0003] A variety of medical implants, particularly pacemakers and / or neurostimulators, are known from the prior art. These are routinely implanted into a patient's body and deliver electrical currents or impulses to the patient's tissue via one or more electrifiable electrodes. The electrodes are typically located directly on or attached to the surface of the implant, pacemaker, or neurostimulator housing.

[0004] Alternatively – preferably to allow for greater flexibility in choosing the implantation site and the electrode delivery or stimulation site – the implant can include a housing that incorporates an interface or connection for electrical and / or mechanical contact with an electrode wire or wire electrode. In this case, the contact electrode(s) are located or formed at the opposite or distal end of the wire electrode, through which the electrical impulses and / or currents are delivered. The wire electrode typically serves to transmit the electrical signals and is therefore electrically insulated from the outside, away from the contact electrode.

[0005] For known implants, especially pacemakers, neurostimulators, or similar devices, a common implantation routine is organized such that the electrode wire or wire electrode is only connected to the rest of the implant, especially the pacemaker or neurostimulator, and / or housing in the operating room, or possibly even only after it has been implanted in the patient's body. This also means that only in POV-P-04608-WP2 - 2 - 02.04.2025

[0006] During the implantation procedure, or possibly even quite late in the process or shortly before its completion, a functional test, particularly of the contact electrode, especially an electrode wire, can be performed. For this purpose, specialists, such as those from the implant manufacturer, are now required in the operating room for implantations or related surgeries. These specialists are necessary in addition to the implanting surgeon and their surgical team to ensure that the implant's contact electrodes are fully functional and can be controlled by the implant as planned and intended.

[0007] This leads to very complex and costly implantation procedures because the surgical team must include another highly qualified specialist. Furthermore, this has the disadvantage that malfunctions can only be detected very late, for example, only after the patient has undergone a complex and sometimes risky operation. In addition to the effort and risk associated with the operation, the established procedure also leads to potentially very costly "waste." If it is only discovered during or at the end of the operation / implantation that the implant and / or contact electrodes are not fully functional, these items have at least been removed from their sterile packaging and may even have already come into contact with human tissue.Such devices or equipment cannot usually be refurbished or reused, which not only leads to a waste of resources but also further increases the costs of a corresponding implantation.

[0008] Approaches already exist to create a contact electrode or contact surface of a pacemaker that is directly on the housing of a POV-P-04608-WP2 - 3 - 02.04.2025

[0009] The prior art does not provide a means of testing a pacemaker designed or intended to be tested within its packaging. This is described, for example, in US 2011 / 0004265 A1. In this case, contact electrodes are attached to the surface of the implant housing with an electrically conductive structure within the packaging. If a wire electrode, including its end-contact electrode, is to be attached or connected to such a pacemaker to deliver a pulse output of an electrical signal or a stimulation pulse to a location away from or at a distance from the housing, as described above, the prior art does not offer a means of testing the functionality of the implant, including the housing and the wire electrode with its end-contact electrode. The user / surgeon is still required to assemble and / or test the entire system before or during implantation.This still leads to the disadvantageous situation outlined above.

[0010] Against this background, the object of the present invention is to propose a packaging body, a packaging system and a method for packaging a medical implant which overcome the disadvantages in the prior art and in particular enable a functional test of the total implant comprising a housing and a wire electrode with a contact electrode in a sterile packaged state of the total implant in a packaging body.

[0011] This problem is solved with regard to the packaging body according to the invention, having the features of claim 1. With regard to the packaging system, this problem is solved with a system according to claim 11. The problem of the invention is solved with regard to the method for packaging an implant, having the features of claim 14. POV-P-04608-WP2 - 4 - 02.04.2025

[0012] Advantageous embodiments of the present invention are the subject of the following description, the description of the figures, the figures and the dependent claims.

[0013] To avoid unnecessary repetition, all features described and disclosed in the device below shall also be deemed to be disclosed and claimable in the corresponding process, and vice versa.

[0014] The packaging body according to the invention for a medical implant, in particular a pacemaker and / or a neurostimulator, comprising a housing and a wire electrode connected to the housing, with a contact electrode arranged in a distal end region of the wire electrode, which is particularly designed for transmitting electrical signals, preferably to living tissue, comprises packaging material which includes closure means extending along a sealing contour of the packaging material, wherein at least a part of the packaging material and the closure means define a sterile and / or sterilizable interior of the packaging body in which the implant is received in a sterile packaged state.

[0015] According to the invention, the packaging body, particularly in its interior, has electrically conductive contact means arranged such that the contact electrode of the implant, which is spaced apart from the implant housing via the wire electrode and simultaneously electrically, and preferably mechanically, connected to the implant via the wire electrode, comes into contact with or can be brought into contact with these means in the sterile packaged state. This enables the entire implant, or at least the assembly of housing and wire electrode together with the contact electrode, to be used in a state in which it will later be implanted, i.e., in particular without subsequent POV-P-04608-WP2 - 5 - 02.04.2025

[0016] Assembly or connection steps can be subjected to a functional test in a sterile packaged state because, through a permanent or manufacturable electrically conductive contact between the contact electrode and the contact means of the packaging body, in particular the interior, the transmission or emission of electrical signals from the contact electrode and thus the functionality of the contact electrode and also of the entire implant including the wire electrode and the electrical / electronic components located in the housing of the implant can be verified.

[0017] This achieves a particularly advantageous way in which the functionality of the contact electrode, its interaction with the implant, the functionality of the wire electrode, and the functionality of the electronics and electrical components within the implant housing can be verified while the implant is in its sterile packaging. This allows, for example, at the end of the packaging process and at other critical points before final implantation into a patient's body, the functionality of the entire implant, including the wire electrode, to be checked without having to break the sterile packaging, for example, by opening the seal or any other part of the packaging material, and without having to perform any assembly or connection steps of the implant components.

[0018] For example, multi-layer plastic film, such as a multi-layer laminate, can be used as packaging material. Other easily sterilizable packaging materials can also be used. The sealing methods for creating the seal can also vary. These can include welding the packaging material to itself or to other materials. Adhesive bonding using a POV-P-04608-WP2 - 6 - 02.04.2025 is also possible.

[0019] Bonding agent or adhesive can be used to form the sealing material and the seal contour, provided that these are suitable and / or approved for a sterilization process of the sealed or closed interior - including the implant.

[0020] As already mentioned, the implant housing can contain the electrical and / or electronic components necessary for generating and outputting electrical pulses via the wire electrode and its contact electrode. Advantageously, an energy storage device, such as a battery or accumulator, can also be integrated into the housing. Furthermore, it is advantageous to include an antenna and communication electronics within the housing to wirelessly receive electrical energy and to facilitate communication, particularly data exchange, with an external electrical device.

[0021] It is particularly advantageous to have several contact electrodes, for example 2, 3 or 4 contact electrodes, at the distal end of the wire electrode.

[0022] The contact element of the packaging body according to the invention, particularly in the interior of the space sealed by the closure means, can be designed, for example, such that a portion of the contact electrode or of several contact electrodes, or a complete surface of the contact electrode or of the several contact electrodes, rests against the contact element or can be brought into contact with it. The spacing of the contact electrodes from the implant housing via the wire electrode also creates a distance between the contact elements and the environment of the housing within the interior of the packaging body. This initially makes the packaging body larger than if the wire electrode and housing were packaged separately and / or in an electrically and / or mechanically decoupled state, which is counterintuitive in itself (PQV-P-04608-WP2 - 7 - 02.04.2025).For the first time, this offers the possibility of performing a functional test of the entire implant system, including the wire electrode and / or housing, which would otherwise not be possible, especially not in its sterile, packaged state. The contact elements can have different shapes and be made of different materials. Advantageous embodiments will be discussed further below. However, without anticipating this, it should be mentioned that the contact elements can advantageously be designed as a film, a disc, a gel volume, a porous body, or the like.

[0023] According to an advantageous embodiment of the invention, the contact means can be designed and / or arranged such that the at least one contact electrode, in the sterile packaged state, is in direct or immediate and permanent contact with the contact means. This embodiment represents a particularly simple implementation of the invention, since it can be ensured relatively easily and reliably during packaging that the at least one contact electrode is in contact with the contact means and that this contact is maintained or remains in place even when the interior is closed or sealed. The greatest challenge here is then to coordinate the interaction between the contact electrode and the contact means during the packaging process with the lifespan or durability of the sterile packaging.

[0024] It must be ensured that, during the shelf life of the sterile packaging of the implant, no mechanical, chemical, and / or electrochemical interactions occur between the contact electrode and the contact medium within the packaging body that could adversely affect the functionality, quality, or safety of the contact electrode—particularly with regard to its long-term residence in a living body and thus its biocompatibility. This requirement can be ensured or met through the appropriate selection of materials for both the contact electrode and the contact medium.For example, appropriately inert or insensitive materials or at least surfaces can be used on the side of the contact means and the contact electrode, which can be in direct and immediate contact with each other for a relatively long time without any corresponding change or influence.

[0025] In an alternative embodiment, it can also be advantageously provided that the contact means are movably arranged in the interior and can be brought or transferred into a contact position in which the contact electrode rests against the contact means without having to undo the sterile packaged state, in particular without having to open the sealing contour of the closure means.

[0026] In this context, it can be particularly advantageous for the contact means to be brought into the contact position from the outside, preferably without contact, through the packaging material. For example, this transition could be magnetic. In an advantageous embodiment, the contact means could be metallic and / or magnetic, and a permanent magnet and / or electromagnet brought from outside into close proximity to the contact means could be used to transmit a force to the contact means and thus effect the transition into the contact position.

[0027] For example, a guide may be provided on the outside of the packaging body, in particular on the outside of the packaging material – for example by a protruding material rib or several protruding material ribs – which guides the external POV-P-04608-WP2 - 9 - 02.04.2025

[0028] Magnets provide a guide and thus facilitate or ensure that the contact elements inside the packaging body are moved into the contact position without having to undo the sterile packaged state of the packaging body.

[0029] If necessary, it may also be provided in the interior that guiding means or guiding contours project inwards into the interior of the packaging body, which provide or accomplish the guiding of the contact means.

[0030] As an alternative to magnetically induced transfer of the contact elements into the contact position, an alternative design can also be implemented. For example, it is possible to design the packaging or packaging body in such a way that it is deformable, e.g., bendable or flexible, without thereby compromising its sterile state, whereby the aforementioned deformation, e.g., bending, of the packaging body simultaneously causes the contact elements to be forcibly transferred into the contact position inside or within the packaging body.

[0031] In a further, particularly advantageous embodiment, it can be provided that a removable separating or protective layer is arranged between the contact electrode and the contact means, and that is designed in such a way that removal and the resulting contact means can be attached to the contact electrode without having to undo the sterile packaged state.

[0032] The movable design of the contact means, as well as the alternative or additional provision of a removable separating or protective layer between the contact means and the contact electrode, has the advantage (POV-P-04608-WP2 - 10 - 02.04.2025) that a permanent or continuous contact between the contact electrode and the contact means is not required, which entails the challenges described above. At the same time, a key challenge of this embodiment is establishing contact between the contact means and the contact electrode without compromising or opening the sterile state of the packaging body. The advantageous separating or protective layer can also be advantageously arranged in such a way that external deformation, e.g.,Folding or bending of the packaging body is possible, which, on the one hand, removes the separating or protective layer between the contact elements and the contact electrode, but at the same time maintains the sterility or sterile state of the packaging body. The separating or protective layer can, for example, be designed as an electrically insulating flap, made of plastic, which is attached to the packaging material on one side, so that localized deformation of the packaging material causes the separating or protective layer inside to also shift or move.

[0033] In a further, particularly advantageous embodiment of the packaging body, it can be provided that the packaging body has guiding elements, in particular guiding contours, which define the position and orientation of the implant and / or the position of the wire electrode, especially including the contact electrode, in the packaged state. Preferably, the guiding contours can define the position of a housing for the implant and the wire electrode including the contact electrode. This ensures that the contact electrode can be contacted securely and reliably for testing and functional verification purposes. Furthermore, it enables visual inspection of the entire implant system, including the housing and wire electrode, in the assembled or connected state. POV-P-04608-WP2 - 11 - 02.04.2025

[0034] Furthermore, this ensures that the implant, and in particular the wire electrode, advantageously including the contact electrode, assumes well-defined states and / or positions in its sterilely packaged state. This allows the corresponding arrangement, positioning, and / or movement of the contact elements to be precisely and reliably aligned and / or tailored to the contact electrode, thus ensuring reliable electrical contact via the system. Additionally, this prevents unwanted or excessive forces from acting on the connection between the housing and the wire electrode, such as tensile forces or forces resulting from bending of the wire electrode. This not only makes the connection verifiable and testable but also protects and preserves it.

[0035] The guiding elements or guide contours are preferably formed in the interior of the packaging body. For example, the guiding elements can be designed as a contoured insert or as structures connected to the packaging material or formed or shaped from the packaging material, in particular monolithically.

[0036] In a further, particularly advantageous embodiment of the packaging body, pressure-forming elements can be provided which, in the sterile packaged state, exert force on the wire electrode, preferably together with the contact electrode, in the direction of the contact elements. These pressure-forming elements can also be designed, for example, as an insert, as a molded part connected to the other packaging material, or as a monolithic component of the packaging material. The pressure-forming elements can be particularly advantageously adapted to the closure means and / or the sealing contour so that, when the sealing contour is formed, a pressure-forming effect on the contact electrode in the direction of the contact elements is generated. The pressure force can be POV-P-04608-WP2 - 12 - 02.04.The 2025 standard will be advantageously tailored to whether there is a permanent or temporary, immediate and direct connection between the contacting means and the contact electrode. For example, a protruding platform of the packaging material can serve as a contact element.

[0037] Another particularly desirable design of the packaging body involves the contact elements comprising metallic material. As mentioned above, the presence of metallic material on the contact elements allows for magnetically induced displacement or movement of the contact element. Furthermore, the at least partially metallic construction of the contact elements enables electrical contacting of the contact electrode and thus allows for external functional testing of the contact electrode while the packaging is sterile.

[0038] The contact elements can be, for example, a metallic plate or a metallic disc. A plastic element with a metallic coating can also be advantageously used. For instance, a part of the packaging material itself coated with a metallic material can also form or provide the contact elements.

[0039] As an alternative to a metallic or metal-containing material, other electrically conductive materials can also be used. For example, gels, pastes, fibrous materials, porous materials, or the like could be used, provided they exhibit a certain degree of electrical conductivity. These can also be plate-shaped, in which case—even with a metallic design—the contact electrode is advantageously positioned on a surface. Alternatively, a solid form, for example, as a gel, cuboid, or the like, can be provided, in which case the contact electrode preferably projects into or is inserted into the volume of the contact material.

[0040] In a particularly advantageous further development, it can be provided that the contact materials have a conductivity that corresponds to, or at least substantially corresponds to, that of living, especially human, tissue. This allows, to a particularly advantageous extent, a condition to be provided during the functional testing of the contact electrode that corresponds as closely as possible to the finally implanted state of the contact electrode.

[0041] For example, the conductivity can be adjusted or specified accordingly via the composition of the surface of the contact medium or the material composition of the contact medium.

[0042] In a further development of the packaging body, it can be particularly advantageous to include, in particular optical, conductivity indicators in the contact elements, which indicate or make detectable any deviation from a predetermined or original conductivity value of the contact elements. This ensures that, at the time of functional testing of the contact electrode, it is apparent whether and, if so, to what extent the original or predetermined conductivity value of the contact elements is still present or maintained. The conductivity indicators can be provided or implemented, for example, by coloring or discoloring the contact elements. Dyes can be used for this purpose, for instance, which cause a discoloration or color change depending on humidity or electrical resistance. POV-P-04608-WP2 - 14 - 02.04.2025

[0043] Furthermore, as already indicated above, the contact means can be designed such that several, in particular all, individual electrodes of the contact electrode are in contact with the contact means or can be brought into contact with them in the sterile packaged state. This ensures that all individual electrodes of the contact electrode can be tested for functionality.

[0044] The aforementioned problem is also solved by a packaging system for the sterile packaging of a medical implant comprising the medical implant, in particular a pacemaker and / or a neurostimulator, with a housing and a wire electrode connected to the housing, wherein a contact electrode, in particular for transmitting electrical signals, preferably to living tissue, is arranged in a distal end region of the wire electrode, wherein, according to the invention, a packaging body according to one of the previously disclosed embodiments is provided. In the sterile packaged state, the implant together with the contact electrode is then located in the interior of the packaging body, wherein, in the sterile packaged state, the contact electrode, which is spaced apart from the housing of the implant via the wire electrode, is electrically, and preferably mechanically, connected to the housing via the wire electrode (14).

[0045] Due to the appropriate arrangement of the contact elements in relation to the contact electrode, the contact elements and the contact electrode are either permanently and consistently in direct contact with each other, or can be brought into contact with each other as described in detail above, without having to break or remove the sterile packaging or the sterile packaged state. Thus, with the packaging system according to the invention, the functionality of the contact electrode and the entire implant, comprising POV-P-04608-WP2 - 15 - 02.04.2025 the housing and the wire electrode electrically connected to the housing, can be checked both after completion of the packaging process and sterilization of the packaging body, and before the operation for implantation of the implant, without having to break or remove the sterility of the packaging body.

[0046] This allows, in particular, that if a defect or incomplete, limited, or non-existent functionality of the contact electrode and / or wire electrode is detected, it can be replaced along with the rest of the implant, especially the attached housing, within the still sterile, sealed packaging, and, if necessary, returned to the manufacturer. In other words, this means that the functional test, performed before the sterile condition is broken, covers the entire implant and not just the housing or the wire electrode separately.In the event of a detected error or defect, for example, a replacement implant, also in a suitable sterile packaging or packaging body, can be used for implantation after the functionality of the entire system consisting of housing and wire electrode – again advantageously in its still sterile packaged state – has been tested, ensured and / or confirmed for this replacement implant.

[0047] It is particularly advantageous that, in the sterile packaged state, the contact electrode is electrically conductive and, in particular, mechanically connected, especially in a functional state, to the rest of the implant, preferably the housing, via the wire electrode. This advantageously allows not only the functionality of the contact electrode to be verified, but also, advantageously, the entire functionality of the implant, including the function of the connected POV-P-04608-WP2 - 16 - 02.04.2025

[0048] The wire electrode and the electrical and / or electronic components within the housing can be inspected. This allows for a particularly advantageous, comprehensive inspection of the medical implant while it is still in its sterile, packaged state. Furthermore, this has the significant advantage that the additional specialist required for implantation, as described in the introduction above, may be completely eliminated or become unnecessary.

[0049] Because of a prior mechanical and / or electrical, in particular functional, connection of the implant and wire electrode, preferably including the contact electrode, and the associated functional test while still packaged, the manufacturer and / or packer of the implant can, in turn, independently of the implantation process, test the functionality of the implant and wire electrode and ensure it before shipping or delivery.The implantation or surgical team, in particular the surgeon, can then either proceed with the implantation without further inspection or, before irrevocably removing the sterile packaging from the packaging, ensure once again that the implant as a whole, and thus the components within the housing and the wire electrode including its connection to the housing, as well as the function and interaction of the contact electrode with the other components, are fully functional. This inspection can be carried out particularly advantageously by ensuring that, on the one hand, the implant is functionally connected to the contact electrode and, on the other hand, that the functionality of the contact electrode can be verified in the sterile packaging by its contact with the contact elements located inside the packaging.

[0050] In a further advantageous embodiment of the packaging system, it includes a control device with wireless communication POV-P-04608-WP2 - 17 - 02.04.2025

[0051] An interface is provided for establishing a communication link with the implant, preferably via a wireless communication interface of the implant. This advantageously allows the functionality of the implant and / or contact electrode to be verified at various stages of the manufacturing and use process, particularly after the sterile packaging has been prepared, without compromising the sterility of the implant and / or contact electrode. This significantly increases the reliability that only functional implants and contact electrodes reach the operating rooms for implantation and that implantation or a corresponding operation is only performed when the surgical team or surgeon is certain that the implant, including the contact electrode, is functional.

[0052] Wireless communication interfaces on both the control unit and the implant can be implemented using standardized transmission frequencies and protocols, such as NFC, Bluetooth, WLAN, LTE, 5G, or similar technologies. Alternatively, a proprietary wireless communication protocol and associated hardware can be used.

[0053] According to a further, particularly advantageous embodiment of the packaging system, it can be provided that the control device for functional testing of the implant, including functional testing of the contact electrode, is set up when a communication connection with the implant exists.

[0054] The aforementioned problem is also solved by a method for the sterile or sterilizable packaging of an implant, in which, in a process step, the implant, in particular a pacemaker and / or a neurostimulator, with a contact electrode for transmitting electrical signals, preferably to living tissue, is arranged in a packaging material. In a further process step, a sealing contour is formed in the packaging material by means of closure means, whereby at least a part of the packaging material and the closure means define a sterile or sterilizable interior of the packaging body in which the implant, in particular together with the contact electrode, is received.

[0055] According to the invention, it is provided that when arranging the implant in the packaging material, a housing of the implant is already electrically, and preferably mechanically, connected to a contact electrode via a wire electrode, and the contact electrode is spaced from the housing via the wire electrode, is arranged in a distal end region of the wire electrode, and the contact electrode of the implant is arranged and / or aligned with respect to the packaging body, in particular in the interior, such that in a sterile packaged state the packaging body brings an electrically conductive contact element of the packaging body into contact with the contact electrode or can be brought into contact with it.

[0056] Regarding the advantages and beneficial effects of the process, reference is made to the packaging system and packaging body described above.

[0057] According to an advantageous embodiment of the method, the wire electrode, particularly together with the contact electrode, can be electrically and, more preferably, mechanically connected to the housing before the sealing contour is formed via the closure means. This ensures that, in the sterile packaged state, not only the functionality of the contact electrode but also of the entire implant including the contact electrode can be verified, which can advantageously be carried out wirelessly and from the outside.

[0058] For the sake of completeness, it should be noted that, within the scope of the present invention, the electrical connection between the housing and the wire electrode is to be understood as establishing an electrical connection between the wire electrode and electronic or electrical components of the implant located inside the housing. A conductive connection with the surface of the housing is neither provided nor advantageous. Rather, the wire electrode is connected to the electrical components inside the housing but is electrically insulated from the housing material itself.

[0059] Accordingly, a further, particularly desirable embodiment of the method provides that, in the sterile packaged state, a functional test of the implant, including a functional test of the wire electrode and / or the contact electrode and / or a functional test of the electrical and / or mechanical connection of the housing to the wire electrode, is carried out by means of a control device wirelessly connected to the implant. This functional test can preferably be carried out several times before opening the packaging and ending the sterile packaged state, on various occasions, for example, upon completion of the packaging, and at least in preparation for implantation.Particularly preferably, the control device may be designed in such a way that an essentially fully automatic functional check is carried out or performed, so that even less trained personnel, for example a member of the operating team or the surgeon himself, can perform the functional test of the implant together with the contact electrode immediately before POV-P-04608-WP2 - 20 - 02.04.2025.

[0060] implantation and removal of the sterile packaged state can be performed.

[0061] The present invention is described below with reference to drawings showing only schematic, advantageous embodiments.

[0062] It shows:

[0063] Fig. 1: a packaging body according to the invention in an unsealed state;

[0064] Fig. 2: a packaging system consisting of a packaging body and an implant including a contact electrode in a sterile packaged state according to a first embodiment;

[0065] Fig. 3: a packaging system consisting of a packaging body and an implant including a contact electrode in a sterile packaged state according to a second embodiment;

[0066] Fig. 4: a packaging system consisting of a packaging body and an implant including a contact electrode in a sterile packaged state according to a third embodiment;

[0067] Fig. 5: an exemplary process flow for carrying out the method according to the invention.

[0068] Fig. 1 shows a packaging body 01 for an implant, in particular a pacemaker or a neurostimulator, in which, in the packaged state, a wire electrode of the implant is already connected to a housing of the implant. Only the packaging body POV-P-04608-WP2 - 21 - 02.04.2025 is shown in Fig. 1.

[0069] Figure 01 shows the implant, but not the packaging system. Reference is made to Figures 2 to 4 for the packaging system shown.

[0070] The packaging body 01 can, for example, comprise a film-like packaging material 02, which includes closure means 03 to form a seal contour. Since Fig. 1 shows an open or unsealed state of the packaging body 01, the closure means 03 are not yet connected to form the seal contour or closed.

[0071] In the example shown in Fig. 1, the packaging body can comprise a bottom part 04 and a lid part 05, which are preferably connected to each other in a transition area 06. The transition area 06 can also be a monolithic part of the packaging material 02 formed with the bottom part 04 and the lid part 05. For example, the bottom part 04 can be provided with a guide element 07, either as a separate insert, as material connected with the packaging material 02, or as a monolithic element formed from the packaging material 02. This guide element 07 determines the position and arrangement of an implant and a contact electrode in the packaged and / or sterile state of the packaging body. The guide elements 07 can be implemented as continuous or interrupted webs projecting inwards. The guide elements are particularly preferably used to guide the housing of the implant and to guide the wire electrode of the implant, which is connected to the housing in the packaged state.Furthermore, it is provided that, for example, contact means 08 are implemented in the base part 04, which, in the sterile packaged state of the packaging body 01, ensure that a contact electrode of the implant's wire electrode is permanently and directly in contact with the contact means 08, or can be brought into contact with them, as described in detail with reference to Figures 2 to 4, while simultaneously being spaced apart from the implant housing. POV-P-04608-WP2 - 22 - 02.04.2025.

[0072] The lid part 05 of the packaging body 01 also incorporates pressure elements 09, which are positioned and aligned such that, when the packaging body 01 is closed and a sealing contour is formed along the closure elements 03, a contact electrode of the wire electrode is subjected to force in the direction of the contact elements 08. In the example shown in Fig. 1, the closure and the formation of the sealing contour along the closure elements 03 can be achieved, for example, by pivoting or folding the bottom part 04 and the lid part 05 relative to each other, so that the closure elements 03 come into contact with each other in a substantially congruent manner. The pressure elements can, for example, be designed as foam bodies.Alternatively, another body that is at least partially elastically deformable and can exert a pressing force on the contact electrode in its sterile packaged state may be used, provided that it is suitable for sterilization and does not cause any harmful interactions through contact with or on the contact electrode.

[0073] Fig. 2 shows the closed and sealed packaging body 01 of the embodiment of Fig. 1 in a transparent top view. It can be seen that the bottom part 04 and the lid part 05 are essentially congruent and that a sealing contour 10 has been formed by the closure means 03, enclosing an interior space 11. An implant 12 is arranged in the interior space 11, which has a housing 13 and a wire electrode 14, with a contact electrode 15 formed at the distal end of the wire electrode 14, which can, for example, comprise several individual electrodes 16. In the top view of Fig. 2, it can be seen that the contact means 08 and the pressure means 09 are arranged essentially congruently with each other. The implant 12, in particular the housing 13 and the wire electrode 14, is / are defined or positioned in its / their position and orientation by the guide means 07.The closure means 03 and the sealing contour 10 are advantageously matched to the contact means 08, the pressure means 09 and the contact electrode 15 in such a way that a permanent and direct or immediately electrically conductive contact is created between the contact electrode 15 and the contact means 08 in the closed or sealed state of the packaging body 01.

[0074] As shown in Fig. 2, the packaging system 17 can advantageously be designed so that the contact electrode 15 is electrically conductive and, in particular, mechanically connected, especially preferably in a functional state, to the rest of the implant 12, particularly to the housing 13. This allows the functionality of the wire electrode 14, together with the contact electrode 15 and the rest of the implant 12, especially any electrical components or electronics arranged inside the housing 13, to be checked with an external control device 18 when the packaging body 01 is closed and the implant 12 is thus in a sterile or sterilizable packaging state. This means that the entire implant system, comprising the wire electrode 14 and the housing 13, as well as the interaction of said components, including their connection, can be tested.Consequently, the implant 12 can be tested in the state in which it will ultimately be used in the body to be implanted. For this purpose, communication can take place via a wireless communication interface 19 on both the control unit 18 and the implant 12. This interface prompts or stimulates the implant 12—i.e., the contact electrode 15 itself, the connection between the wire electrode 14 and the housing 13, as well as any electrical and / or electronic components inside the housing 13 and their interaction with the wire electrode 14 and / or contact electrode 15—to perform a test mode. Upon completion of the test mode, corresponding control data regarding functionality is transmitted back to the control unit 18. The required electrical energy can be supplied to the packaged implant 12 either by POV-P-04608-WP2 - 24 - 02.04.2025 will be provided by a battery or accumulator provided in the implant or alternatively will be transmitted wirelessly from the control unit 18 to the implant 12 via the wireless communication interface 19.

[0075] Fig. 3 shows a section of an alternative embodiment of a packaging system 17 according to the invention, comprising a packaging body 01. In this embodiment, the contact means 08 are designed to be movable and only come into contact with the contact electrode 15 of the implant after a movement, for example, along the direction arrow A. To perform a test of the entire implant 12, the wire electrode 14 is again connected to the housing (not shown). The displacement or movement of the contact means 08 can be induced externally, preferably without opening the sealing contour 10 of the closure means 03 and thus without disturbing the sterile packaged state. The displacement or movement of the contact means 08 can be achieved externally, for example, via a magnetic interaction with a permanent magnet or electromagnet.

[0076] To limit or define the movement of the contact means 08, further guide contours 20 can be provided in the interior 11 of the packaging body 01. In this embodiment, the contact between the contact electrode 15 and the contact means 08 is advantageously only temporary and can, for example, be explicitly established or brought about at times when the functional test, as sketched with reference to Fig. 2, is carried out. Corresponding guide contours, which define the movement of the magnet, can also be formed on the outside of the packaging body 01. These are not shown in Fig. 3. POV-P-04608-WP2 - 25 - 02.04.2025

[0077] Figure 4 shows an embodiment in which a separating or protective layer is arranged between the contact electrode 15 and the contact means 08 in a sterile packaged state and without any externally induced, intentional deformation of the packaging body 01. In this embodiment as well, an electrical and / or mechanical connection between the wire electrode 14 and the housing 13 is provided in the part of the packaging system not shown, so that testing of the entire implant, and not just the wire electrode 14, can be carried out via the contact means 08. The separating or protective layer 21 can, for example, be designed as a thin flap or film and be connected, for instance, to the packaging material 02 or the sealing contour 10.The packaging body 01 can have a target deformation line 22, which is recognizable to the user, for example, by optical markings and / or is formed by corresponding material changes or structural changes in the material of the packaging body 01 and which allows the packaging body 01 to be deformed without removing or impairing the sterile packaged state.

[0078] However, as outlined in Fig. 4, a deformation relative to the target deformation line 22 can ensure that the separating or protective layer 21 between contact electrode 15 and the contact means 08 is removed, thus creating contact between contact electrode 15 and contact means 08, resulting in an electrically conductive connection between contact means 08 and contact electrode 15, which allows for another functional test of the implant 12 together with contact electrode 15.

[0079] Figure 5 illustrates an exemplary process for packaging an implant according to the present invention. In a first process step S1, an unsealed package, essentially comprising a packaging body according to the invention, POV-P-04608-WP2 - 26 - 02.04.2025, can be provided. In a subsequent process step S2, an implant can be provided. In a sub-process step S2.1, it can be provided that an electrically conductive and / or mechanical, in particular functional, connection is established between the wire electrode and the rest of the implant, for example, by connecting the wire electrode together with the contact electrode to a housing of the implant. In a subsequent process step S3, the implant with the connected contact electrode can be arranged in the still open or unsealed packaging body.For example, the housing, the electrode wire and the contact electrode can be positioned and / or aligned using guides.

[0080] In a further process step S4, it can be provided that the packaging body is closed by the closing means along the sealing contour in such a way that a sterile or sterilizable interior is created in which the implant, together with the connected wire electrode and its contact electrode, is arranged. The closing or sealing of the packaging body can be designed in such a way that a permanent or subsequent contact between contact electrode 15 and the contact means 08, as already described above, is established or can be established.

[0081] In a subsequent process step S5, for example, the sterilization of the packaging body together with the enclosed implant can take place.

[0082] In a further process step S6, for example, a functional test of the entire implant, including the wire electrode and its contact electrode, can be performed via an external control device using appropriate wireless communication interfaces. The functional test can preferably be repeated as often as necessary and can be carried out, in particular, by the manufacturer / packer and additionally by the surgical team or surgeon before or immediately before the implantation is to take place and the packaging or packaging body is to be opened and the sterile packaging removed.

[0083] POV-P-04608-WP2 - 28 - 04 / 02 / 2025

[0084] Reference symbol list:

[0085] 01 Packaging body

[0086] 02 Packaging material

[0087] 03 Sealing agents

[0088] 04 Base section

[0089] 05 Lid part

[0090] 06 Transition area

[0091] 07 Management tools

[0092] 08 Contact materials

[0093] 09 Contact material

[0094] 10 Seal contour

[0095] 11 Interior

[0096] 12 implants

[0097] 13 cases

[0098] 14 wire electrode

[0099] 15 Contact electrode

[0100] 16 individual electrodes

[0101] 17 Packaging system

[0102] 18 Control device

[0103] 19 Wireless communication interface

[0104] 20 leadership contours

[0105] 21 Separating or protective layer

[0106] 22 Deformation line

[0107] S1-S6 Process step

Claims

POV-P-04608-WP2 - 1 - 02.04.2025 Patentansprüche 1. Packaging body for a medical implant (12), in particular a pacemaker and / or a neurostimulator, comprising a housing and a wire electrode (14) connected to the housing, with a contact electrode (15) arranged in a distal end region of the wire electrode (14), comprising packaging material (02) which includes closure means (03) extending along a sealing contour (10) of the packaging material (02), wherein at least a part of the packaging material (02) and the closure means (03) define a sterile and / or sterilizable interior space (11) of the packaging body (01) in which the implant (12) is received in a sterile packaged state, characterized in that the packaging body (01), in particular in the interior space (11), has electrically conductive contact means (08) which are arranged such that the contact electrode (15), which is spaced apart from the housing of the implant via the wire electrode (14) and simultaneously electrically connected to the housing,and preferably mechanically connected to the wire electrode (14) of the implant (12) in the sterile packaged state, the contact electrode (15) is attached to it or can be attached to it.

2. Packaging body according to claim 1, characterized in that the contact means (08) are designed and / or arranged such that the contact electrode (15) is in direct and permanent contact with the contact means (08) in the sterile packaged state.

3. Packaging body according to claim 1 , POV-P-04608-WP2 - 2 - 02.04.2025 characterized in that the contact means (08) are movably arranged in the interior (11) and can be brought into a contact position in which the contact electrode (15) is in contact without having to remove the sterile packaged state.

4. Packaging body according to claim 1 or 3, characterized in that it is characterized by a removable separating or protective layer (21) which is arranged between the contact electrode (15) and the contact means (08) and which is designed in such a way that removal and a resulting contact of the contact means (08) on the contact electrode (15) is possible without having to undo the sterile packaged state.

5. Packaging body according to one of the preceding claims, characterized by Guiding means (07), in particular guiding contours, in the interior (11) which define the position and orientation of the implant (12) and / or the position of the wire electrode (14), in particular including the contact electrode (15), in the packaged state.

6. Packaging body according to one of the preceding claims, characterized by Contact means (09) which, in the sterile packaged state, apply force to the wire electrode (14), preferably together with the contact electrode (15), in the direction of the contact means (08).

7. Packaging body according to one of the preceding claims, characterized in that the contact means (08) comprise metallic material. POV-P-04608-WP2 - 3 - 04 / 02 / 2025 8. Packaging body according to one of the preceding claims, characterized in that the contact means (08) have a conductivity corresponding to that of living, in particular human, tissue.

9. Packaging body according to one of the preceding claims, characterized in that the contact means (08), in particular optical, comprise conductivity indicator means which indicate a deviation from a predetermined or original conductivity value.

10. Packaging body according to one of the preceding claims, characterized in that the contact means (08) are designed such that several, in particular all, individual electrodes (16) of the contact electrode (15) are in contact with the contact means (08) in the sterile packaged state or can be brought into contact with them.

11. Packaging system for the sterile packaging of a medical implant, comprising the implant (12), in particular a pacemaker and / or a neurostimulator, with a housing and a wire electrode (14) connected to the housing, wherein a contact electrode (15) is arranged in a distal end region of the wire electrode (14), characterized by a packaging body (01) according to one of claims 1 to 10, in which the implant (12) is received, wherein in the sterile packaged state the contact electrode (15), which is spaced apart from the housing (13) of the implant via the wire electrode (14), is electrically, and preferably mechanically, connected to the housing via the wire electrode (14). POV-P-04608-WP2 - 4 - 04 / 02 / 2025 12. Packaging system according to claim 11 or 12 characterized by a control device (18) with a wireless communication interface (19) which is configured to establish a communication connection with the implant (12), preferably via a wireless communication interface (19) of the implant (12).

13. Packaging system according to claim 13, characterized in that the control device (18) is set up for functional testing of the implant (12) including functional testing of the contact electrode (15) and / or the electrical and / or mechanical connection between the housing (13) of the implant and the wire electrode (14) when a communication connection with the implant (12) is in place.

14. Method for sterile or sterilizable packaging of an implant comprising the following process steps: - Arranging an implant (12), in particular a pacemaker and / or a neurostimulator, with a contact electrode (15) in a packaging material (02); - Forming a sealing contour (10) in the packaging material (02) via closure means (03), whereby at least a part of the packaging material (02) and the closure means (03) define a sterile and / or sterilizable interior (11) of a packaging body (01) in which the implant (12) is contained. POV-P-04608-WP2 - 5 - 02.04.2025 characterized in that, when arranging the implant in the packaging material, a housing (13) of the implant is already electrically, and preferably mechanically, connected to a contact electrode (15) via a wire electrode (14), and the contact electrode (15) is spaced from the housing via the wire electrode (14) and is arranged in a distal end region of the wire electrode (14), and the contact electrode (15) of the implant (12) is arranged and / or aligned with respect to the packaging body (01), in particular in the interior (11), such that in a sterile packaged state, an electrically conductive contact means (08) of the packaging body (01) comes into contact with or can be brought into contact with the contact electrode (15).

15. Method according to claim 15, characterized in that the wire electrode (14), in particular together with the contact electrode (15), is electrically conductively connected to the implant (12), and in particular mechanically, especially preferably in a functionally ready manner, connected to the housing (13) of the implant (12), before the sealing contour (10) is formed via the closure means (03).

16. Method according to claim 15 or 16, characterized in that, in the sterile packaged state, a functional test of the implant (12) including a functional test of the contact electrode (15) and / or a functional test of the electrical and / or mechanical connection of the housing (13) with the wire electrode (14) is carried out by means of a control device (18) wirelessly connected to the implant (12).

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