WO2025237657A1

WO2025237657A1 - Safe design of a plastic tube for implantable electrodes through a functional geometry for the alignment of electrical connector contacts, as well as a safe assembly and alignment of electrical connector contacts

Info

Publication number: WO2025237657A1
Application number: PCT/EP2025/061472
Authority: WO
Inventors: Denny JACOB; Lars HANNIG; Carsten Fründt; Toni KAMENZ
Original assignee: Biotronik SE and Co KG
Current assignee: Biotronik SE and Co KG
Priority date: 2024-05-16
Filing date: 2025-04-28
Publication date: 2025-11-20
Anticipated expiration: 2026-11-16

Abstract

The present invention, inter alia, relates to a method, a method for manufacturing an implantable connector, comprising a) providing a cylindrical element, b) removing a first portion of the cylindrical element to form a longitudinal recess on an outer surface of the cylindrical element and c) removing a second portion of the cylindrical element to form a circumferential recess on the outer surface of the cylindrical element such that a distal and a proximal protrusion is formed on respective edges of the circumferential recess.

Description

Applicant: BIOTRONIK SE & Co. KG

Date: 28.04.2025

Our Reference: 22.054P-WO

Safe design of a plastic tube for implantable electrodes through a functional geometry for the alignment of electrical connector contacts, as well as a safe assembly and alignment of electrical connector contacts

The present disclosure relates to a method for manufacturing an implantable connector, a computer program for executing the method and an implantable connector.

Patients suffering from an Alzheimer disease (e.g., leading to a pronounced tremor) or a chronical pain syndrome may be burdened with severe symptoms and respective undesired constraints on the life of these patients. Ever since the discovery of these diseases, extensive research has been conducted to understand the origin of these diseases with the goal of developing therapies to either cure the patients or to at least partially suppress the syndromes and thus to reduce the psychological stress for the patients accompanied with such a disease.

Besides the therapies which rely on medications (e.g., pills) that may be administered to counter the symptoms of these diseases, further therapy concepts have been developed which rely on providing certain areas of, e.g., the human brain and/or the spine, in which certain undesired symptoms are supposed to arise, with electrically stimulating pulses. In particular, based on the latter therapy concept, a significant improvement of the life quality of affected patients has been observed.

These stimuli may often be generated by dedicated (implantable) devices, such as neurostimulators, e.g., spinal cord stimulators (SCS).

These devices may, e.g., be connected to implantable electrodes by means of respective connectors. Particularly, such implantable electrodes are also referred to as implantable electrode leads. It appears apparent that stringent demands may be set to these (lead) connectors as they may have to be rather small which may make them rather fragile. This may generally lead to fragile (lead) connectors and an associated rather complicated manufacturing process.

Typically, a (lead) connector may be provided with one or more electrical contacts. These electrical contacts need to be located at certain predefined locations at the connector which can be cumbersome and error prone.

Moreover, in a conventional manufacturing process there is a certain risk that a rupturing of the electrical contacts and/or the wires and/or an attachment point of the electrical contacts and wires occurs during the manufacturing process of a connector (e.g., due to mechanical stress acting onto the contacts/wires). Moreover, it may be difficult in conventional connector manufacturing processes to attach the wires to the electrical contact due to a lack of fixation of the wires, preferably in a stress-relieving manner, which may lead to an overall increased manufacturing time.

Due to these disadvantages, there is a need to improve the manufacturing process of connectors as they are used for implantable devices, such as neurostimulators or SCS devices and also of connectors in general.

These drawbacks may at least partially be overcome by a first aspect of the present invention, which relates to a method for manufacturing an implantable (lead) connector. The method may comprise a) providing a cylindrical element and may comprise b) removing a first portion of the cylindrical element to form a longitudinal recess on an outer surface of the cylindrical element and may comprise c) removing a second portion of the cylindrical element to form a circumferential or radial recess on the outer surface of the cylindrical element such that a distal and a proximal protrusion is formed on respective edges of the circumferential or radial recess.

Based thereon, the cylindrical element (e.g., a hose blank) may be provided with a functional structure, notably by providing the cylindrical element with the longitudinal recess and the circumferential or radial recess which may act as a holding structure for additional components of the implantable connector. This may ensure, at an early stage of the manufacturing process, that potential guiding means may be foreseen in the holding structure that may support a simplified arrangement of electrical contacts and/or wires attached thereto. These guiding means may allow a definition of potential locations and/or orientations of subsequently added components of the connector (e.g., in a form- and/or force-fitting manner).

For example, a longitudinal element (e.g., wire) may be arranged within the longitudinal recess, such that it can slide along the cylindrical element. At the same time, an annular shaped element (e.g., forming an electrical contact surface of the final connector) connected to the longitudinal element may be placed at its designated position, namely a protrusion formed on an edge of the circumferential or radial recess. Providing the circumferential or radial recess in such a way that it forms protrusions at proximal and distal sides, enables the provision of a multitude of such recesses along a longitudinal axis of the cylindrical element, such that a plurality of such annular elements (each corresponding to an electrode) may be safely positioned while the cylindrical element may maintain, on average a constant crosssection such that its stability may not be compromised. Also, by using both protrusions, annular-shaped elements may be kept in placed both distally and proximally.

This may generally facilitate the process of arranging the electrical contacts at the right positions with respect to their co-axial, rotational and/or longitudinal orientation compared to prior art approaches which only provide cylindrical connector geometries with very little guiding and/or instability at their end. Moreover, there is no need that further components of the implantable connector are pre-manufactured (e.g., to a certain) length nor that these components need to be at least temporarily attached to the holding structure (e.g., by clamps) until a final assembly step occurs. Therefore, potential sources for errors, which may arise from a wrong location and/or orientation of the components of the implantable connector, may efficiently be suppressed. Moreover, the risk that a positioned component (e.g. wire or annular element, etc.) may unintendedly be displaced, e.g., moved to another (wrong) position, may be reduced. This may specifically be of importance, if the implantable connector is covered in a resin which may potentially lead to a displacement of components placed in the recesses (e.g., due to a floating of the respective components in the presence of the resin).

Furthermore, the guiding and positioning means provided by the recesses explicitly allow that components added to holding structure may be added in a non-stretched state (i.e., without mechanical stress acting onto the respective components, e.g., wires). This, in turn, may advantageously contribute to a suppression of a rupturing of the respective components and/or an undesired spatial shift of the components due to, e.g., mechanical stress.

Particularly, the method according to the invention may be part of a manufacturing of an implantable electrode lead. Such electrode lead may comprise a lead body having a first end portion and a second end portion, wherein particularly the implantable (lead) connector according to the invention may be formed on the first end portion. On the second end portion of the lead body an electrode arrangement may be formed, the electrode arrangement comprising a plurality of electrode bodies, e.g., eight or sixteen electrode bodies, wherein the electrode bodies are configured to delivery therapeutic electrical pulses to adjacent bodily tissue, e.g., nerve tissue, when being implanted. Particularly, each of the electrode body may be connected to an annular element via a longitudinal element as described above.

In some cases, the method may additionally comprise the step of providing the cylindrical element with visual and/or haptic guiding means. The visual guiding means may, e.g., be adapted such that they indicate (e.g., as dots, lines, pictograms, etc.) a reference axis and/or a reference location (e.g., a top and/or a bottom position) that may allow a manufacturer of the implantable (lead) connector to distinctively derive the potential locations for subsequently added components of the implantable (lead) connector.

In some examples, also a method for manufacturing an implantable connector may be provided which comprises: a) providing a cylindrical element and b) removing at least a portion of the cylindrical element, such as the first portion and/or the second portion as described herein; wherein c) the removing is performed by laser ablation. In some examples, the methods and aspects described herein may also be used for other types of connectors.

The circumferential or radial recess may, in some examples, not be rotationally symmetric. For example, the circumferential or radial recess may be provided such that a cross-sectional view onto the cylindrical element placed at a certain orientation may differ from a cross- sectional view onto the cylindrical element when rotated by, e.g., 45° about a longitudinal axis of the cylindrical element. In other words, the circumferential or radial recess may not be uniform when revolving the cylindrical element (e.g., the circumferential or radial recess may not be provided with a constant depth or width, i.e., the depth and/or width of the circumferential or radial recess may be varied as it evolves on the surface of the cylindrical element) or it may only extend along a portion of the circumference of the cylindrical element (e.g. less than 360°, less than 270°, less than 180° or less than 90° or less than 45°).

By providing the circumferential or radial recess such that it is not rotationally symmetric, the implantable (lead) connector may be provided with a preferred axis such that a certain rotational state of the implantable (lead) connector may be distinguishable from another rotational state of the implantable (lead) connector relative to the longitudinal axis of the cylindrical element. This may advantageously contribute to a suppression of a manufacturing of the implantable (lead) connector in a wrong rotational state, in which components of the implantable (lead) connector may erroneously be placed at a position of the connector which is not foreseen for the respective components of the implantable (lead) connector. Therefore, manufacturing errors may efficiently be suppressed at an early stage of proceedings.

Particularly, the circumferential or radial recess is configured as a mounting or alignment mark for mounting or receiving an annular element as described above. Particularly, the implantable (lead) connector according to the invention comprises a plurality of circumferential or radial recesses configured to receive a respective plurality of annular element, wherein particularly each of the recesses is arranged at a different position along the circumference of the cylindrical element, and each of the recesses is assigned to a distinct annular element. The longitudinal recess may be provided with an at least partially circular cross-section and/or the circumferential recess may be provided with a rectangular cross-section.

In this context, the cross-section may be understood as a view onto the cylindrical element when cut transverse to its longitudinal direction.

By providing the longitudinal recess with a partially circular, e.g. semi-circular, crosssection, optimized guiding means for a longitudinally extending and circularly shaped (as seen in a cross-section transverse to a longitudinal direction of the circular element) electrically conducting element, may be provided.

In case the circumferential or radial recess is provided with a rectangular cross-section, distinct protrusions may be formed at a distal side of the circumferential or radial recess and on a proximal side of the circumferential or radial recess. These formed edges may be used to precisely arrange, e.g., components of the implantable (lead) connector therebetween such that an undesired movement of said components, e.g., along a longitudinal direction of the implantable (lead) connector (e.g., towards a proximal end of the implantable connector) is avoided during the manufacturing process.

The removing of the first portion of the cylindrical element may be performed such that the longitudinal recess is shorter than the cylindrical element. That is, the longitudinal recess may, e.g., originate from a distal-most portion of the cylindrical element, may extend along the longitudinal direction of the cylindrical element and may end in a proximal portion of the cylindrical element without extending to a proximal-most portion. In other words, the proximal-most portion of the cylindrical element may be separated from the proximal-most portion of the longitudinal recess by 0.5 cm to 10 cm, preferably by 1 cm to 8 cm, more preferably by 2 cm to 6 cm and most preferably by 3 cm to 5 cm or by any other suitable distance. Particularly, the cylindrical element may form a lead body of an implantable electrode lead.

The removing of the second portion of the cylindrical element may be performed such that the circumferential or radial recess at least partially overlaps with the longitudinal recess. In some examples, the circumferential or radial recess may be located such that it overlaps with the longitudinal recess at a distal portion (but not necessarily a distal end) of the cylindrical element.

This may allow an improved positioning of the components of the implantable connector and may advantageously contribute to an improved (form-) fitting of the respective components of the implantable connector at their intended locations.

Providing the cylindrical element may comprise providing the cylindrical element with at least one non-centered lumen extending along a longitudinal direction of the cylindrical element. In some cases, the at least one non-centered lumen may comprise two lumina, three lumina, four lumina, six lumina, seven lumina, eight lumina or even more than eight lumina.

By providing the cylindrical element with at least one non-centered lumen, additional guiding means for the components of the implantable (lead) connector may be provided such that a precise and simplified manufacturing process of the implantable connector may be facilitated.

The removing of a first portion of the cylindrical element may be performed such that an opening of the at least one non-centered lumen may be formed at the proximal protrusion. This may allow an easier placement and arrangement of the components of the implantable connector, in particular, of those components which need to be arranged in the non-centered lumen. More specifically, a wire may slide along the longitudinal recess formed by removing the first portion until it reaches the proximal protrusion wherein it may then slide into the opening, there.

Additionally or alternatively, an opening of the at least one non-centered lumen may be provided at a proximal end of a longitudinal recess. That is, the second portion may be removed such that the resulting longitudinal recess may end at an opening of the noncentered lumen. For example, in a proximal -most portion of the cylindrical element, in which the longitudinal recess may not be formed, the non-centered lumen may serve as a feedthrough. Based thereon, a distinct termination of the implantable connector may be formed in its proximal-most portion in which, conducting elements (such as wires) may be safely arranged within one or more lumina.

In some examples, the cylindrical element may additionally or alternatively be provided as a tubular element comprising a centered lumen.

The method may further comprise removing at least one, preferably seven, additional first portions of the cylindrical element to form respective additional longitudinal recesses on the outer surface of the cylindrical element. The method may further comprise removing at least one, preferably seven, additional second portions of the cylindrical element to form respective additional circumferential or radial recesses in the outer surface of the cylindrical element such that additional distal and proximal protrusions are formed on respective edges of the additional circumferential recesses. Each of the additional longitudinal recesses may overlap with at least one respective additional circumferential or radial recess in a distal region of the cylindrical element.

This may allow that wires and/or electrodes may be received in a defined manner in each pair of longitudinal and circumferential or radial recess. Moreover, pre-defined separations between at least two adjacent longitudinal recesses and at least two circumferential or radial recesses may be provided. Therefore, the respective locations for subsequently added components of the implantable connector may be predefined and do not need to be determined (e.g., by measuring) by a member of a production facility. This may further advantageously contribute to an improved and faster manufacturing of the implantable connector and may additionally allow the formation of a repeatedly occurring functional structure (e.g., circumferential-recess-wise) to support the manufacturing of a more versatile implantable (lead) connector.

The method may further comprise providing an electrically conducting annular element comprising an electrically conducting longitudinal element attached thereto. Moreover, the method may comprise arranging the conducting longitudinal element in the longitudinal recess and arranging the annular element in or at the circumferential or radial recess, particularly by sliding the annular element over the cylindrical element until it abuts the proximal protrusion.

The electrically conducting longitudinal element may comprise at least one wire. In some cases, the electrically conducting longitudinal element may comprise at least two, at least three, at least four, at least five, at least six, at least seven, at least eight, at least nine or at least ten wires. In some cases, if the electrically conducting longitudinal element may comprise at least two wires, the at least two wires may be twisted. In some cases, the electrically conducting longitudinal element may comprise a rigid electrically conducting element (e.g., a copper rod).

Placing the electrically conducting longitudinal element in the longitudinal recess may support a precise and stable alignment of the conducting longitudinal element against rotational displacement. By sliding the annular element over the cylindrical element until it abuts the proximal protrusion, a detent of the annular element against a further (undesired) movement in a proximal direction may be achieved.

The electrically conducting annular element may act as an electric contact, e.g., as a contact pad that may allow an electrically conducting connection to a respective pole of the implantable connector, e.g., if the implantable (lead) connector is inserted into a corresponding jack or socket. Particularly, the annular element forms the respectively pole of the implantable (lead connector), i.e., the annular element is configured to electrically contact a respective counter contact in the above-mentioned jack or socket.

In an example, the longitudinal recess is provided as a straight recess, i.e., a recess that oriented in parallel relative to a longitudinal axis of the cylindrical element. This may advantageously support a simplified manufacturing process and may be helpful to avoid an unintended twisting of components of the implantable plug placed therein.

Each of the longitudinal and/or circumferential or radial recesses may be provided with a same width (measured transverse relative to a longitudinal extension of each of the recesses). In some cases, the width of the recesses may not be the equal for at least two of the longitudinal recesses and the circumferential or radial recesses, respectively. This may allow that electrically conducting longitudinal elements with a different thickness (e.g., with a different diameter) may be insertable into the respective recesses. This may advantageously contribute to a more versatile implantable plug.

Each of the longitudinal recesses may be provided with a same cross-sectional shape. Alternatively, at least two of the longitudinal recesses may be provided with a cross-sectional shape that differs from each other. Some of the longitudinal recesses may be adapted to form a symmetric cross-section (e.g., a semi-circular and/or circular cross-section). In some alternative examples, the longitudinal recesses may be provided with an eccentric cross- sectional shape. That is, a circular-cross sectional shape may additionally be provided with a protrusion such that a cross-section of the longitudinal recesses is not rotationally symmetric (relative to a rotation axis that extends along a longitudinal direction of a respective longitudinal recess and in parallel to the longitudinal axis of the cylindrical element).

The method may further comprise providing at least one additional electrically conducting annular element, each comprising an electrically conducting longitudinal element attached thereto. Moreover, the method may comprise arranging the electrically conducting longitudinal element of the at least one additional electrically conducting annular element in the at least one additional longitudinal recess and the method may comprise arranging the at least one additional annular element in or at the at least one additional circumferential or radial recess, particularly sliding the at least one additional annular element over the cylindrical element until it abuts the at least one additional proximal protrusion.

Each of the electrically conducting annular elements may act as an electrical contact to establish an electrically conducting connection between the implantable connector and a corresponding jack into which the implantable connector may be inserted.

The aspects described with respect to the first electrically conducting annular element and with respect to the first electrically conducting longitudinal element may equally apply to the at least one additional electrically conducting annular element and the at least one additional electrically conducting longitudinal element.

Providing at least one additional electrically conducting annular element and at least one additional electrically conducting longitudinal element may allow providing the implantable (lead) connector with at least a second electrical contact. This may contribute to the manufacturing of a versatile implantable connector.

The at least one additional electrically conducting annular elements may comprise at least two additional electrically conducting annular elements, wherein the removing the respective second portions of the cylindrical element may be carried out such that the annular elements are arranged equidistantly from each other along a longitudinal direction of the cylindrical element.

By arranging the annular elements in an equidistant manner, a simplified implantable connector design may be facilitated.

The removing may comprise ablating, preferably laser ablation.

The ablation process may in some cases be combined with a milling process and/or a grinding process and/or any other suitable method for providing the circular element with respective recesses as discussed herein.

Manufacturing tolerances may typically be better than 4 French (Fr). That is, a maximum deviation from a desired measure may typically be less than 4 Fr. In some examples, the manufacturing tolerance may be better than 3 Fr or even better than 2 Fr.

By providing the removing such that it comprises laser ablation, a precise, minimally invasive and cost-effective method for providing a circular element with respective recesses may be provided. Therefore, a tailored, fast and precise manufacturing process for an implantable connector may be provided. A second aspect of the present invention relates to a computer program comprising code for performing any of the aforementioned methods.

The functions described herein may be implemented in hardware, software executed by a processor, firmware, or any combination thereof. If implemented in software executed by a processor, the functions may be stored on or transmitted over as one or more instructions or code on a computer-readable medium. Other examples and implementations are within the scope of the disclosure and appended claims. For example, due to the nature of software, functions described herein can be implemented using software executed by a processor, hardware, firmware, hardwiring, or combinations of any of these. Features implementing functions may also be physically located at various positions, including being distributed such that portions of functions are implemented at different physical locations.

A third aspect of the present invention relates to an implantable (lead) connector. The implantable (lead) connector may comprise a cylindrical element and may further comprise a longitudinal recess on an outer surface of the cylindrical element. Moreover, the implantable connector may comprise a circumferential or radial recess on the outer surface of the cylindrical element that forms a distal and a proximal protrusion on respective edges of the circumferential or radial recess.

The cylindrical element, the longitudinal recess and/or the circumferential or radial recess may be provided as outlined above.

Moreover, the implantable (lead) connector may be provided with visual and/or haptic means to indicate an orientation of the implantable (lead) connector, which may facilitate the manufacturing of the implantable (lead) connector and may simplify the insertion of the implantable connector into, e.g., a jack.

The implantable connector may further comprise an annular conducting element arranged in or at the circumferential or radial recess, and particularly abutting the proximal protrusion or the distal protrusion, and a conducting longitudinal element arranged in the longitudinal recess. The conducting longitudinal element may be conductively attached to the annular conducting element.

This may allow a simplified configuration of an implantable (lead) connector as the annular conducting element may facilitate a rotationally symmetric implantable (lead) connector which may simplify an establishing of an electric connection between the connector and a jack as no preferred orientation of the implantable connector may need to be taken into consideration. This may advantageously simplify the handling of the implantable (lead) connector.

A fourth aspect relates to an implantable electrode lead. The electrode lead comprises lead body having first end portion comprising the implantable connector and an electrode end at a second end portion of the lead body opposite the first end portion, wherein the electrode end comprises an electrode arrangement comprising a plurality of electrode bodies configured to provide therapeutic pulses to bodily tissue, e.g., nerve tissue. Particularly, each of the electrode bodies is connected to one electrically conducting annular element via one electrically conducting longitudinal element of the connector according to the invention.

In one embodiment, the electrode arrangement comprises eight electrodes. In one embodiment, the electrode end is designed in a cylindrical shape and electrode arrangement is formed by a plurality, particularly, eight, annular electrode bodies. In another embodiment, the electrode end is designed as a flattened electrode end, e.g., designed in form of a paddle, wherein the plurality of the electrodes is arranged on side of the flattened electrode end or the paddle. In one embodiment, the flattened electrode end comprises a carrier element configured to support the electrodes of the electrode arrangement.

A fifth aspect relates to an implantable lead system. The implantable lead system comprises a first lead according to the above aspect and a second lead according to the above aspect. In one embodiment, the electrode end of the first lead and second lead is designed as in a cylindrical shape and the electrode arrangement is formed by a plurality (e.g., eight) annular electrode bodies, respectively. In another embodiment, the fist lead and the second lead are joined to a common flattened electrode end (e.g., a paddle), wherein flattened electrode end comprises a plurality of electrode bodies (e.g., sixteen) arranged on one side of the flattened electrode end, wherein a fraction of the plurality of electrode bodies (e.g., eight) is connected to one electrically conducting annular element via one electrically conducting longitudinal element of the connector of the first lead, respectively, and another fraction of the plurality of electrode bodies (e.g., eight) is to one electrically conducting annular element via one electrically conducting longitudinal element of the connector of the first second lead.

It is further emphasized, that the aspects outlined above with respect to an implantable connector are not exclusively limited to implantable connectors only. In some cases, the aspects described above may equally be applied to non-implantable connectors.

It is noted that all aspects described herein may be implemented as a corresponding functionality (means) of the device described herein, as a corresponding step of the methods outlined herein and/or as a corresponding instruction of the computer programs outlined herein. Even if described with reference to an apparatus, method and/or computer program, the aspects outlined herein may be applied to the respective other of an apparatus, method and/or computer program

Possible embodiments of the present invention will be described in more detail in the subsequent detailed description with reference to the following Figures:

Fig. 1 : Illustration of a conventional connector,

Figs. 2A-2B: Exemplary manufacturing process of an implantable connector according to aspects of the present invention;

Fig. 3A-5B: Exemplary embodiments of an implantable connector according to aspects of the present invention.

Possible embodiments of the present invention will be described in the following. For brevity, only a few embodiments can be described. The skilled person will recognize that the specific features described with reference to these embodiments may be modified and combined differently and that individual features may also be omitted if they are not essential. The general explanations in the sections above will also be valid for the following more detailed explanations.

Fig. 1 shows an exemplary illustration of a conventional (implantable) connector 100. The implantable connector 100 comprises a cylindrical element 110 (rotationally symmetric) which is provided as a tubular element, i.e., the cylindrical element 110 possesses a (centered) lumen 120.

The cylindrical element 110 is provided with several longitudinal recesses 130 that are embedded in the cylindrical element 110. In the depicted example, the longitudinal recesses 130 extend from a distal portion D of the cylindrical element 110 to a proximal portion P of the cylindrical element 110.

Moreover, the distal portion D of the cylindrical element is provided with a circumferential or radial recess 140 such that the distal portion D of the cylindrical element 110 is provided with a smaller diameter as the proximal portion P of the cylindrical element 110. At the distal end of the circumferential or radial recess 140 no protrusion is formed. The circumferential or radial recess 140 is further rotationally symmetric. The various longitudinal recesses 130 have equal properties and cannot be distinguished from one another.

The cylindrical element 110 may further be enclosed by a sleeve 150, preferably provided with an inner diameter that exceeds an outer diameter of the cylindrical element 110. This allows that the sleeve 150 may slide over the cylindrical element 110.

Figs. 2A and 2B show exemplary method steps of a manufacturing process 200 of an implantable connector according to aspects of the present invention.

In Figs. 2A and 2B, the respective manufacturing steps, as further described below, are illustrated in three different views: in a skewed view onto a proximal end P of the respective component of the implantable connector (left column), in a side view onto the respective component (center column) and as seen from a skewed view onto a distal portion D of the implantable connector.

The first step 200A of the exemplary method 200 for manufacturing an implantable connector may be initiated with providing a cylindrical element 210. The cylindrical element may be provided with a centered lumen 220 (i.e., the cylindrical element 210 may be provided as a tubular element). The cylindrical element 210 may further be provided with at least one non-centered lumen 240 (preferably eight). In some exemplary cases, the cylindrical element 210 may be made from a rigid material (such that the cylindrical element 210 may not be bendable). In alternative cases, the cylindrical element may be made from a flexible material (e.g., a plastic material, a polymer, a rubber material, etc.) that may allow that the cylindrical element 210 may at least partially be bent.

Afterwards, in step 200B, the cylindrical element 210 may be provided with at least one longitudinal recess 230, preferably with eight longitudinal recesses 230 and may further be provided with eight circumferential or radial recesses 250. The formation of a circumferential or radial recess 250 may lead to the formation of a respective distal edge 230 A and of a proximal edge 230B abutting to a respectively formed circumferential recess 250. At these edges the remaining diameter of the cylindrical element 210 increases, such that respective protrusions form, there.

In some exemplary cases, at least a proximal portion P, more specifically a proximal-most portion P2, of the cylindrical element 210 may not be affected by the manufacturing step of providing the cylindrical element 210 with respective longitudinal 230 and respective circumferential or radial 250 recesses. That is, the respective portion of the cylindrical element 210 may remain unchanged and unaffected by the manufacturing method.

In some cases, a diameter of the proximal -most portion P2 of the cylindrical element 210 may be equal to an initial diameter of the cylindrical element 210. In some cases, a diameter of the cylindrical element 210 at a more distal portion D of the cylindrical element 210 may be provided with a diameter (or average diameter) that is smaller than the diameter of the initial cylindrical element 210. In step 200C, an electrically conducting annular element 260 may be provided. In some cases, the electrically conducting annular element 260 may be provided as an electrically conducting ring. In step 200C, also an electrically conducting longitudinal element 265 may be provided. The electrically conducting element 265 may be provided as discussed above and may be attached to the electrically conducting annular element 260. The connection between the electrically conducting annular element 260 and the electrically conducting longitudinal element 265 may be provided in an electrically conducting manner. In some cases, the electrically conducting longitudinal element 265 may be attached to the electrically conducting annular element 260 on an inner side the electrically conducting annular element 260. In some cases, the electrically conducting longitudinal element 265 may additionally or alternatively be attached to an outer side of the electrically conducting annular element 260 (not shown in Fig. 2A).

The attachment between the electrically conducting annular element 260 and the electrically conducting longitudinal element 265 may be provided in an electrically conducting manner, e.g., by soldering the electrically conducting longitudinal element 265 to the electrically conducting annular element 360 and/or by crimping the electrically conducting annular element 260 and the electrically conducting longitudinal element 265 together.

In some examples, the electrically conducting annular element 260 may be provided with a protrusion 260A, which may preferably be adapted as an eyelet adapted, in turn, to receive the electrically conducting longitudinal element 265. The protrusion 260 A may be adapted to simplify and support the attachment of the electrically conducting longitudinal element 265 to the electrically conducting annular element 260 by means of, e.g., a crimped connection.

In some examples a cross-section of the protrusion 260A may be configured to match a cross-section of a longitudinal recess 230 (as seen when cutting the cylindrical element transverse to its longitudinal axis). In step 200D, at least two (as an example) of the electrically conducting annular elements 260 are slid over the cylindrical element 210 (from the distal portion D of the cylindrical element 210 towards the proximal portion P of the cylindrical element 210).

In some cases, an undesired sliding of the electrically conducting annular element 260 towards the proximal portion P of the cylindrical element 210 may be avoided by providing the circumferential recess 250 with at least a proximal edge (not separately indicated in Figs. 2A and 2B but further described with reference to Figs. 3 A and 3B, below) that may act as a stopper counteracting an undesired sliding movement of the electrically conducting annular element 260 in the proximal direction P beyond a certain point that is defined by the location of the stopper.

This may effectively suppress errors during the manufacturing of the implantable connector as an electrically conducting annular element 260 may only be placed at a certain intended location.

In step 200E, additional electrically conducting annular elements 260 may be provided and slid over the cylindrical element 210 from the distal portion D of the cylindrical element 210 towards the proximal portion P of the cylindrical element 210. In the exemplary manufacturing step 200E, a total of nine electrically conducting annular elements 260 are slid over the cylindrical element.

In step 200F, the interstitial volumes 270 between two adjacent electrically conducting annular elements 260 may be filled with a substance (e.g., a resin and/or any other suitable substance) that may suppress an undesired displacement of the electrically conducting annular elements 260 (e.g., in a proximal and/or a distal direction) after they have been slid to a desired location on the cylindrical element 210. Moreover, the substance allows a filling of the interstitial volumes 270 such that the implantable connector may be provided with a uniform outer shape (e.g., with a constant outer diameter along at least a portion of the connector between the distal portion D and the proximal portion P. As can be seen in steps 200D, E and F, the electrically conducting longitudinal elements 265 may slide through longitudinal recesses and, as they reach the proximal edge of the most proximal circumferential recess, may enter the corresponding non-centered lumen there. They may further slide through the lumen until they exit the proximal end of the cylindrical element 210.

Figs. 3 A and 3B and Figs. 4A and B show examples of an implantable connector according to aspects of the present invention.

More specifically, Fig. 3A shows a first exemplary configuration for an implantable connector 300A. The implantable connector 300A may comprise a cylindrical element 310. The cylindrical element 310 may comprise a centered lumen 320 (that is, the cylindrical element 310 may be provided as a tubular element). Moreover, the cylindrical element 310 may comprise one or more non-centered lumina 340 (e.g., preferably eight) that surround the centered lumen 320. The non-centered lumina 340 are preferably arranged equidistant to each other along a circumferential direction.

The cylindrical element 310 may additionally be provided with one or more longitudinal recesses 350 (preferably eight recesses), e.g., by removing respective first portions of the cylindrical element 310 as outlined above. In some cases, the longitudinal recesses 350 may extend from a distal portion D of the cylindrical element 310 to a proximal portion P of the cylindrical element 310.

The cylindrical element 310 may be provided with one or more circumferential recesses 330 (e.g., preferably eight). The cylindrical element 310 may be provided with the one or more recesses by removing second portions of the cylindrical element 310 as outlined above. The one or more circumferential or recesses 330 may entirely revolve around the center lumen 320 (e.g., by 360° as seen in a cross-sectional view taken transverse to a longitudinal direction of the cylindrical element 310).

In some cases, the circumferential recesses 330 may only revolve the cylindrical element

310 by a fraction of 360° (e.g., as shown in Fig. 3 A for the circumferential element 330 which is adapted as a pad-like element). The circumferential recess 330 forms a distal edge 330A and a proximal edge 330B. In some alternative cases, not shown in Figs. 3A and 3B, at least some of the circumferential recesses 330 may revolve the outer surface of the cylindrical element 310 by 360°.

Additionally or alternatively, the rotational symmetry may be broken by other means, e.g. a varying width, depth, and/or cross-sectional shape.

In some examples, the connector structure depicted in Fig. 3A may be understood as a holding structure based on which a manufacturing process for an implantable connector may be performed.

As depicted in Fig. 3 A, the longitudinal recesses 350 may be arranged relative to the circumferential recesses at a 90° angle.

That is, e.g., an electrically conducting annular element (not shown in Fig. 3A, however, discussed with reference to Figs. 2A and 2B, above) may be provided which may be adapted with, e.g., at least one protrusion on an inner side of the electrically conducting element. The at least one protrusion may be adapted to establish an electrically conducting connection to an electrically conducting longitudinal element (e.g., the electrically conducting longitudinal element 265 as described with reference to Figs. 2A and 2B, above). The at least one protrusion may, e.g., be adapted as a guiding means for the manufacturing process of the implantable connector. During the manufacturing process, when sliding the electrically conducting annular element over the cylindrical element 310, the at least one protrusion may be adapted to be fed into one of the longitudinal recesses 350 from the distal portion D of the cylindrical element 310 and may be guided towards the proximal portion P of the cylindrical element 310 in a respective longitudinal recess 350. The electrically conducting longitudinal element potentially attached thereto may follow the sliding movement.

When the at least one protrusion arrives at the circumferential recess 330, the at least one protrusion may be moved over the distal edge 330A of the circumferential recess 330 but may be prevented by the proximal edge 330B from a further sliding movement towards the proximal portion P of the cylindrical element 310. Moreover, the at least one protrusion may also be prevented from a sliding movement back to the distal portion D of the cylindrical element 310 due to the presence of the distal edge 330A.

In a preferred implementation, the circumferential recess 330 may be provided with a certain base surface, e.g. a rectangular shaped (e.g., square-shaped), such that the at least one protrusion may also be prevented from a movement in a circumferential direction. Therefore, according to an aspect of the present invention, an electrically conducting annular element may be attached to the connector blank in a rotationally and/or longitudinally stable manner.

Moreover, further circumferential recesses 330C and 330D may exemplarily be provided, aligned with respective different longitudinal recesses 350 to support the manufacturing of an implantable connector with multiple electrical connectors arranged along a longitudinal direction of the implantable connector.

Fig. 3B shows another exemplary implementation of an implantable connector according to an aspect of the present invention.

Reference numerals 310, 320, 330A-D, 340, 350 of Fig. 3B correspond to the reference numerals 310, 320, 330A-D, 340 and 350 as described with reference to Fig. 3 A, above.

Fig. 3B depicts another potential arrangement of the circumferential recesses 330 as compared to the locations of the circumferential recesses 330 described with reference to Fig. 3 A, above. That is, the location(s) at which the cylindrical element 310 may be provided with a circumferential recess 330 (or more than one circumferential recess 330) is not fixed but may be varied according to the situational needs. Therefore, an aspect of the present invention may allow a versatile arrangement of potential electrical contacts at various positions of the cylindrical element 310 (with respect to a rotational and/or longitudinal orientation).

Figs. 4A to 4C shows an example of an implantable connector according to aspects of the present invention being particularly essential identical to the example of Figs. 3A and 3B. Fig. 4A and 4B show perspective views of the connector, wherein Fig. 4B shows a 180° turned (around the longitudinal axis) view of Fig. 4A. Fig. 4A shows a side view of the connector of Fig. 4A and 4B, and a plurality of cut-views of the connector at each circumferential or radial recess 430.

Like the example of Fig. 3, the connector comprises a cylindrical element having a centered lumen 420 and one or more non-centered lumina 440 (e.g., preferably eight) that surround the centered lumen 420, wherein the non-centered lumina 440 preferably are arranged equidistant to each other along a circumferential direction. The connector further comprises one or more (preferably eight) longitudinal recesses 450, wherein particularly the one or more longitudinal recesses 450 are at least partly formed by the one or more non-centered lumen 440 after removing portions of the cylindrical element 310 as outlined above. Furthermore, the connector comprises one or more circumferential or radial recesses 430, wherein one or more circumferential or radial recesses 430, particularly each of the circumferential or radial recesses 450, are delimited by a distal edge 330A and a proximal edge 330B.

Particularly, the circumferential or radial recesses 430 are configured as alignment mark for each of the electrically conducting annular elements 260 (not shown in Fig. 4A to 4C), wherein particularly each circumferential or radial recess 430 is designated to receive a distinct electrically conducting annular element 260. Particularly shown in Fig. 4C, the circumferential or radial recesses 430 are preferably arranged such at connector that two adjacent recesses 430 are arranged on opposite sides of the connector, respectively.

A comparison between the exemplary implementations depicted in Figs. 3A, 3B and Figs. 4A to 4C show that the functional structure formed by the circumferential or radial recesses 330, 430 and the longitudinal recesses 350, 450 is not limited to a single embodiment. Instead, a large variety of different implantable connector geometries may be formed in dependence on the location of the circumferential or radial recesses 330, 430 and their position relative to the longitudinal recesses 350, 450 accounting for various situational requirements. Therefore, aspects of the present invention may facilitate the manufacturing of an implantable connector for a large variety of applications.

Claims

1. A method for manufacturing an implantable connector, comprising: a) providing a cylindrical element (210; 310; 410); b) removing a first portion of the cylindrical element to form a longitudinal recess (250; 350; 450) on an outer surface of the cylindrical element (210; 310; 410); c) removing a second portion of the cylindrical element (210; 310; 410) to form a circumferential recess (230; 330; 430) on the outer surface of the cylindrical element (210; 310; 410) such that a distal (330A; 430A) and a proximal protrusion (330B; 430B) is formed on respective edges of the circumferential recess (230; 330; 430).

2. The method according to claim 1, wherein the circumferential recess (230; 330; 430) is not rotationally symmetric.

3. The method according to any one of the preceding claims, wherein the longitudinal recess (250; 350; 450) is provided with an at least partially circular cross-section and/or wherein the circumferential recess (230; 330; 430) is provided with a rectangular cross-section.

4. The method according to any of the preceding claims, wherein the removing of the first portion of the cylindrical element (210; 310; 410) is performed such that the longitudinal recess (250; 350; 450) is shorter than the cylindrical element (210; 310; 410).

5. The method according to any of the preceding claims, wherein the removing of the second portion of the cylindrical element (210; 310; 410) is performed such that the circumferential recess (230; 330; 430) at least partially overlaps with the longitudinal recess (250; 350; 450).

6. The method according to any of the preceding claims, wherein providing the cylindrical element (210; 310; 410) comprises: providing the cylindrical element (210; 310; 410) with at least one non-centered lumen (240; 340; 440) extending along a longitudinal direction of the cylindrical element (210; 310; 410).

7. The method according to any of the preceding claims, wherein the removing of the first portion or the second portion of the cylindrical element (210; 310; 410) is performed such that an opening of the at least one non-centered lumen (240; 340; 340) is formed at the proximal protrusion (330B).

8. The method according to any of the preceding claims, further comprising: removing at least one, preferably seven, additional first portions of the cylindrical element (210; 310; 410) to form respective additional longitudinal recesses (250; 350; 450) on the outer surface of the cylindrical element (210; 310; 410); removing at least one, preferably seven, additional second portions of the cylindrical element (210; 310; 410) to form respective additional circumferential recesses (230; 330; 430) in the outer surface of the cylindrical element (210; 310; 410) such that additional distal (330A; 430A) and proximal protrusions (330B; 430B) are formed on respective edges of the additional circumferential recesses (230; 330; 430); wherein each of the additional longitudinal recesses (250; 350; 450) overlaps with at least one respective additional circumferential recess (230; 330; 430) in a distal region of the cylindrical element (210; 310; 410).

9. The method according to any of the preceding claims, further comprising: providing an electrically conducting annular element (260) comprising an electrically conducting longitudinal element (265) attached thereto; arranging the electrically conducting longitudinal element (260) in the longitudinal recess (250; 350); and arranging the annular element (260) in or at the least circumferential recess (230; 330; 430), particularly by sliding the annular element (26) the cylindrical element (210; 310; 410) until it abuts the proximal protrusion (330B; 430B).

10. The method according to claims 8 and 9, further comprising: providing at least one additional electrically conducting annular element (260), each comprising an electrically conducting longitudinal element (265) attached thereto; arranging the electrically conducting longitudinal element (265) of the at least one additional electrically conducting annular element (260) in the at least one additional longitudinal recess (250; 350; 450); and arranging the at least one additional annular element (260) at at least one additional circumferential recess, particularly by sliding the at least one additional annular element (260) over the cylindrical element (210; 310) until it abuts the at least one additional proximal protrusion (330B; 430B).

11. The method according to claim 10, wherein the at least one additional electrically conducting annular element (260) comprises at least two additional electrically conducting annular elements (260); wherein the removing the respective second portions of the cylindrical element (210; 310) is carried out such that the annular elements (260) are arranged equidistantly from each other along a longitudinal direction of the cylindrical element (210; 310; 410).

12. The method according to any of the preceding claims, wherein the removing comprises ablating, preferably by laser ablation.

13. A computer program comprising code for performing the method of any of claims 1- 12.

14. An implantable connector, comprising: a cylindrical element (210; 310; 410); a longitudinal recess (250; 350; 450) on an outer surface of the cylindrical element (210; 310; 450); a circumferential recess (230; 330; 430) on the outer surface of the cylindrical element (210; 310) that forms a distal (330A; 430A) and a proximal (330B; 430B) protrusion on respective edges of the circumferential recess (230; 330; 430).

15. The implantable connector according to claim 14, further comprising: an annular electrically conducting element (260) arranged at the circumferential recess

(230; 330; 430), particularly abutting the proximal protrusion (330B; 430B) or the distal protrusion (330A; 430A); an electrically conducting longitudinal element (265) arranged in the longitudinal recess (250; 350; 450); wherein the electrically conducting longitudinal element (265) is attached to the annular conducting element (260).