IMPLANTABLE ELECTRIC MULTI-POLE CONNECTION STRUCTURE
The invention relates to an implantable electric multi-pole connection between an electric implant and an electric feed and discharge structure. The invention is characterised in that a flexible, film-like, electrically non-conductive, strip-shaped surface element is arranged between the implant and the feed and discharge structure. The surface element comprises at least one first surface, on which a number of electrodes n greater than of equal to two is arranged, which are respectively connected to the electric implant by means of electric connection conductors extending at least in parts inside the surface element. The electric feed and discharge structure comprises at least n lines which are electrically insulated from each other and which are electrically connected to one of the n electrodes. The strip-shaped surface element is wound around a winding axis, which adopts the shape of a helix, along a cover surface of a virtual cylinder provided with a cylinder axis which is straight or curved at least in sections.
- 1-9. -9. (canceled)
- 10. An implantable electrical multi-pole connection for connection between an electrical implant and an electrical feed and discharge, comprising:
a flexible electrically non-conductive surface element formed in a step for connection between the implant and the feed and discharge structure, the surface element having at least one surface on which at least two electrodes are located, each element being connected to the electrical implant via electrical conductors, running at least partially inside the surface element; the electrical feed and discharge structure comprising wires, electrically insulated from each other and each being electrically connected to one of the electrodes; and the surface element is wound around a helical winding axis, after winding around the axis and which is straight or curved at least in sections when the connection is attached between the electrical implant, the electrical feed and discharge.
- View Dependent Claims (11, 12, 13, 14, 15, 16, 17, 18)
Reference is made to PCT/EP2017/079593 filed Nov. 17, 2017, and German Application No. 10 2016 222 712.2 filed Nov. 18, 2016, which are incorporated herein by reference in their entirety.
The invention relates to an implantable electric, multi-pole connection between an electric implant and an electric feed and discharge structure.
Electronic implants suitable for permanent or at least long-term retention in the body are typically used to influence organ functions therapeutically. Examples of known art are cardiac or brain pacemakers. Depending on the application purpose and complexity of the therapeutic objective, generic implants have a large number of electrical feed and discharge lines, which supply the implant in question with electrical control and regulatory signals as well as electrical power. The number of electrical feed and discharge lines for electronically complex implants may well include twenty or more electrical lines assembled into a flexible cable, by which the implant is connected to a control unit, which is usually combined with a power source. The intra-corporeal positioning of the control unit and the power source is usually performed subcutaneously in a part of the body, such as the chest region or near the clavicle, where the external and internal stresses caused by movement are as small as possible for the person, and ease of surgical access is possible.
As a rule, the electrical feed and discharge lines between the implant and the control unit or power source are not integratively designed, but are implemented via at least one interface in the form of an intra-corporeal plug connection, or a detachable or non-detachable electrical connection, such as a bonded or soldered connection. On the one hand, this raises problems related to the installation space required for the interface, and on the other hand it is necessary to make the interface region moisture-resistant on account of the moist intra-corporeal environment.
Using the example of an implantable cuff electrode arrangement to be supplied via a multi-pole feed and discharge structure, the problems existing up to the present time of an implantable electrical multi-pole connection structure known per se will be explained in more detail with reference to the illustrations to be found in
For the purpose of making electrical contact with the microflex structures 5, a ceramic adapter plate 6 is used in a manner known per se, on which, in accordance with the number and arrangement of the microflex structures 5, so-called microflex contacts or microflex pads 7 are attached; these are brought into contact with the microflex structures 5 and are in each case connected individually in an electrically conductive manner to the electrode surfaces 8 attached to the surface of the ceramic adapter plate 6. Individual electric wires 10 of an electric cable 11 are connected to the individual electrode surfaces 8 formed as solder pads via soldered or bonded connections 9. Needless to say, the entire electric connection arrangement shown in
It is obvious that the installation space required for the electrical connection structure of known art increases with the increasing complexity and multi-polarity of the unit to be implanted, as a result of which patient stress and irritation also increases in the same manner.
U.S. Pat. No. 5,324,322 discloses an implantable electrode arrangement with a winding electrode component in a type of cuff electrode, which is connected via a connecting section to a multi-pole connection structure of planar design, onto which a number of electric contact surfaces are applied. In one example of an embodiment, the planar connection structure is wound around an axis, in a manner similar to the winding electrode component. In the wound state, the connection structure takes the form of a hollow cylinder, which has a rigid structure and for the purpose of intra-corporeal location is placed section-by-section around a nerve fiber strand.
The invention is a design of an implantable, electric, multi-pole connection structure between an electric implant and an electrical feed and discharge structure, for example in the form of a multi-pole cable, so that the stress on the patient is significantly reduced, compared to generic connection structures of known art, despite the large number of individual electrical feed lines with which contact is to be made on the implant side. The measures required for this should make it possible to connect an arbitrarily scalable number of electrical feed lines to an implant via a multi-pole connection structure, without requiring any appreciable additional installation space for this purpose.
The implantable electrical, multi-pole connection structure in accordance with the invention is a flexible, film-like, electrically non-conductive, strip-shaped surface element arranged between the implant and the feed and discharge structure, with at least a first surface of the surface element, on which a number of electrodes n≥2 is arranged. Each of the n electrodes is connected to an electrical connection conductor, which is connected to the electrical implant for purposes of at least one of signal control and power supply. The at least n electric connection conductors run at least in parts inside the surface element.
The electrical feed and discharge structure comprises at least n wires, electrically insulated from each other, which are electrically connected at their ends to one of the n electrodes, for example by way of a bonded or soldered connection. In addition, the strip-shaped surface element, along the at least first surface of which the n electrodes are arranged, and in each case are connected to one of the n wires, is wound around a winding axis, which adopts the shape of a helix, along a cover surface of a virtual cylinder provided with a cylinder axis, which is straight or curved at least in sections.
As a result of the winding of the strip-shaped surface element, in accordance with the invention, around a cylinder axis, which is straight or curved at least in sections, along which the electrical feed and discharge structure preferably extends in the form of a bundle of wires, which are assembled as a cable, no additional installation space is required other than that which is already required for the feed and discharge structure. By virtue of the flexibility of the film-like, electrically non-conductive surface element, the patient does not experience any appreciable irritating sensations, as would otherwise arise from a ceramic adapter plate made of rigid material. Instead, the multi-pole, elastic connection structure designed in accordance with the invention is able to adapt individually to the intra-corporeal spatial conditions in question.
A particularly preferred embodiment provides for an integrative design and connection of the implant with the flexible, film-like, electrically non-conductive surface element, in which the number of electric connection conductors n is completely enclosed and integrated, and the ends with which contact is to be made terminate in each case on an electrode on at least a first surface of the surface element. The integrative design of implant and surface element on the one hand makes an electrical contact arrangement between implant and electrical connection structure as the surface element superfluous, and on the other hand, an almost arbitrarily scalable number of electrical connection conductors and their contact electrodes can be implemented with a high degree of integration in the region of the surface element using microsystems process technology.
For reasons of a uniform and procedurally simplest possible feasibility of the electrical contacts between the electrodes provided on the upper surface of the surface element and the individual wires, electrically insulated from each other, of the electrical feed and discharge structure, in what follows is referred to simply as the cable, all n electrodes are arranged on a common surface of the surface element. This also has the additional advantage that after the surface element has been appropriately wound, all wires connected to the surface element are uniformly connected to the electrodes on the surface of the surface element either facing towards or away from the winding axis. The surface element is preferably wound in such a way that the surface of the surface element provided with electrodes is facing radially towards the winding axis or cylinder axis, so that the wires connected to the individual electrodes are radially surrounded at least in parts by the surface element in the wound state.
In order to provide as large a number of electrodes as possible on the surface element, one embodiment envisages populating both opposing surfaces of the surface element with a corresponding number of electrodes, which in each case are connected to the electrical implant via an electrical connection conductor running at least in parts inside the surface element. The number of electrodes n on the first surface of the surface element does not necessarily have to correspond to the number of electrodes m on the opposing second surface of the surface element.
The electrical connection of the individual wires of the cable to the respective electrodes on the at least first surface of the surface element is preferably made by soldering, welding or bonding.
In order to protect the electrical contacts on the electrodes along the wound surface element, together with the wires leading away from the individual electrodes, from the moist intra-corporeal environment, a preferred embodiment provides for a sheath of an electrically insulating, biocompatible material, which preferably fully surrounds at least the region of the surface element. The sheath can be in the form of a tubular potting compound, or in the form of an impermeable shrinkable tube. A person skilled in the art has all the known potting and sheathing techniques necessary to meet all medical product-specific requirements.
The strip-shaped design of the surface element, that is the fact that the surface element is characterised by a longitudinal extent that is much larger than the width that can be assigned to the surface element, enables a helical winding of the strip-shaped surface element along a cover surface of a virtual cylinder. By virtue of the helical winding shape, the strip-shaped surface element in the wound state has a high deformability, or elasticity, transverse to the winding axis, so that a spatial shape of the connection structure is enabled that can be adapted at will to the individual spatial, intra-corporeal conditions, whereby patient stress can also be minimized, in particular in cases in which the connection structure has a large number of electrical contacts. The large number of electrodes n are preferably arranged along the upper surface of the strip oriented radially inwards. In this manner, the numerous n wires leading away from the individual electrodes are radially surrounded by the spiral or helical, strip-shaped surface element.
In order to prevent the electrical contact points of all wires from forming electrical short-circuits with each other after the surface element has been appropriately wound, the contact points are accordingly mutually insulated with a potting compound or an additional coating. In a preferred embodiment, the cylindrical volume, which surrounds the surface element wound around the winding axis and located radially inside, is filled with an elastic, electrically insulating, biocompatible material.
The compliant multi-pole connection structure of the invention, in the form of the flexible, film-like, electrically non-conductive surface element, is not necessarily possible to be connected to the implant. It is also possible that only the electric connection conductors running at least in parts inside the surface element are connected directly or indirectly to the implant and lead into the surface element that is separate from the implant.
The invention'"'"'s compliant implantable electric multi-pole connection structure is particularly suitable for electrical signal and power transmission between an implant designed as a cuff electrode arrangement and an intra- or extra-corporeal electrical control and power unit.
A cuff electrode arrangement known per se has already been described with reference to
The integrative design of the supporting substrate with the invention'"'"'s compliant design of the surface element is particularly suitable, because both the supporting substrate and the surface element are of a film-like design and are a flexible, electrically non-conductive material, which preferably is a polymer and most preferably a polyimide. In the same way as the supporting substrate region, which lies in a cuff around the nerve fiber bundle, and which is able to wind or roll itself up by an implantation of a mechanical pre-stress by use of process and material; the surface element, which has the n-electrodes and is preferably a strip, is also embodied with a mechanical pre-stress for the purpose of an independent winding. Further details on the compliant implantable electric multi-pole connection structure of the invention can be found with reference to the following figures.
The invention will be described below in an exemplary manner by way of embodiments with reference to the figures, without any limitation of the general inventive concept. Here:
The supporting substrate 4 has an elongated supporting substrate section 15, which extends along an axis A. The axis A defines the winding axis around which the strip-shaped surface element 12 is wound, forming a helical wound structure.
Before or after the winding process, the individual electrodes 14, which are distributed along the strip-shaped surface element 12, are connected to the ends of electrical wires 18, for example by way of a soldering or bonding process. See
After appropriate shrinking of the silicon tube and, if necessary, additional internal filling of the tube volume with a suitable material, preferably PDMS, an impermeable protection of all internal electrical contact surfaces is achieved, see
In contrast to the connection technique of known art described above, the compliant implantable electrical multi-pole connection structure has a high degree of flexibility and requires only one single electrical connection per wire, which can be produced by way of a bonding, welding or soldering process. Furthermore, the number of electrodes and thus the multi-polarity of the connection structure can be scaled to almost any extent. Thus, in this context, the strip-shaped surface element 12 can be appropriately extended on the one hand, and populated with electrodes on both surfaces of the surface element on the other hand, that is in addition to the n electrodes 14 on the first surface 13 of the surface element, a number of electrodes (14′) m, greater than or equal to two, are attached to a second surface (13′) of the surface element, which is oriented away from the first surface (13) of the surface element. See
- 1 Cuff electrode arrangement
- 2 Nerve fibre bundle
- 3 Electric lines
- 4 Biocompatible supporting substrate
- 5 Microflex structures
- 6 Ceramic adaptor plate
- 7 Microflex contacts, microflex pads
- 8 Electrode surfaces
- 9 Solder point
- 10 Electric supply wire
- 11 Cable
- 12 Strip-shaped surface element
- 13 First surface of the surface element
- 13′ Second surface of the surface element
- 14, 14′ Electrode
- 15 Supporting substrate section
- 16 Helix
- 17 Auxiliary body
- 18 Wires
- 19 Sheath
- A Winding axis