Patent Application
20130217992
The present invention generally relates to electrode devices and, in particular, to an electrode device for cardiovascular application with at least the features specified in claim 1.
Such electrode devices as they are known, for example, from U.S. Pat. No. 7,238,883, U.S. Publication No. 2007/0225784 and/or U.S. Pat. No. 7,395,116, are known to have an elongated electrode body made from an insulating material, one or a plurality of electrodes for detecting cardiological signals and/or for outputting electrocardiological stimulus signals, as well as supply lines serving for the electrical connection of the electrodes. The supply lines are, in each case, guided in adequate lumina in the electrode body.
Such electrode devices which are used, for example, as pacemakers, defibrillators and other multi-electrode systems, are utilized for diagnostic and therapeutic purposes. As supply lines, more and more often, non-elastic electrical conductors are employed such as, for example, cables and strands.
Due to the eccentric arrangement of a plurality of conductors of this non-elastic type in multi-lumen constructions, as well as in lumenless arrangements, a relative movement between these conductors and the electrode insulation in a multi-lumen arrangement, or among the insulated supply lines in a lumenless construct, is generally unavoidable. Naturally, in the case of one or a plurality of cables which show little play in their guiding lumina of the insulating electrode body and which, furthermore, with regard to their cross-section, are arranged radially on the outside or asymmetrically about a lumen guiding a central coil conductor and, therefore, do not lie in the neutral phase of the electrode body, this, depending on the stress state, results in friction between the involved components which, in particular in the case of extensive bending movements within an electrode body, can be significant compared to a conventional coaxial structure consisting of, in each case, elastic inner and outer conductors in the form of coils.
In order to optimize the manufacturing process, electrode devices with a plurality of individual electrodes, as they are used for stimulating and sensing heart action potentials, for defibrillation or for connecting sensors or actuators, often consist of prefabricated subassemblies which have to be assembled during the course of the manufacture. In this connection, it is known for conventional electrode devices to establish such connections by means of adhesively bonding a transfer sleeve, which serves as a connection coupling and acts as a kind of “bandage”, around the joint between the prefabricated sub-components. For example, a shock electrode subassembly of a defibrillator electrode device can be assembled with the actual elongated electrode body in the aforementioned manner. The transitions with transfer sleeves can represent interference points in the form of sudden diameter changes in the otherwise isodiametric shape of the electrode body, which interference points, after an implantation of the electrode device, can be the cause of increased tissue growth which can affect the function of the system.
From the prior art, it is known through prior public use to solve the problem of non-elastic cables and strands as a conductor by twisting the cables. However, this measure is known only directly at the connection of the cable or the strand to a plug connector and serves there exclusively for increasing the bending fatigue strength at the transition between conductor cable and plug connector.
Another known solution is the transfer of the conductor cable into an elastic coil. The problem here is the fact that by this transition between a cable and a wire coil in the high voltage path of an electrode device, the electrical properties of the electrode device are significantly diminished. In this respect, this prior art is not feasible.
The present invention is directed toward overcoming one or more of the above-identified problems.
Proceeding from the above-described problems of the prior art, it is an object of the present invention to refine an electrode device in such a manner that movements of the supply lines, in particular if they are configured as non-elastic cables or strands, relative to the insulating electrode body are minimized, and that for the implementation, connection couplings or transfer sleeves are avoided by suitably designing the electrode device.
At least the above object is achieved by the features disclosed in the independent claim(s). According to that, a compensating hose section inserted in a parting point in the electrode body is provided, wherein the compensating hose section has a maximum diameter that corresponds to the electrode body. Helically shaped receptacles for each supply line are incorporated in this compensating hose section. Furthermore, with its joining sides facing toward the electrode body, the compensating hose section is connected to the latter in a hermetically sealed manner.
By laying the supply lines in a helically shaped configuration in the region of the compensating hose section, the electrode body can be subjected to bending influences in the region of said compensating hose section without any problems because tensile loads acting on the line section situated on the outer side of the bend are compensated by the compaction of this supply line on the inner side of the bend within the compensating hose section. In this respect, the electrode body is therefore particularly flexible in the region of this compensating hose section without significant internal friction forces being generated. Advantageously, due to the increased flexibility in the region of the compensating hose sections, such electrode devices are physiologically more compatible. With regard to product safety, electrode devices with multi-lumen structures become more reliable because they are less sensitive to bending load alternations. This is also facilitated by the reduced friction between the conductors in the adjacent lumen in the case of a multi-lumen structure, or between adjacent insulated conductors in the case of a lumenless construction.
By connecting the compensating hose sections to the adjacent electrode body via a hermetically sealed connection at their joining sides toward the electrode body, furthermore, transfer sleeves and the corresponding work steps to attach the same can be eliminated. Also, with the sleeveless construction, sudden diameter changes are avoided and an isodiametric structure of the electrode device is ensured.
According to a preferred embodiment of the electrode device, the receptacles for the supply lines in the compensating hose section can be formed as helically shaped lumina or as helically shaped grooves which are open on the outer side.
In the latter case, the compensating hose section with its grooves receiving the supply lines is preferably enclosed on the outside with a cover sleeve. In contrast to the prior art, however, this is unproblematic with regard to an isodiametric structure of the electrode device because, in this case, the compensating hose section has a radius that is reduced by the wall thickness of the cover sleeve.
A particularly preferred embodiment of the present invention is obtained when using an electrode device which comprises at least one shock coil on the electrode body. The shock coil is usually formed from a conductive helically wound coil wire. Particularly preferred in this case is the arrangement of the compensating hose section at least partially underneath this shock coil, wherein at least one joining side of the compensating hose section that faces toward the electrode body lies underneath the shock coil. Via a step with a reduced diameter, the electrode coil then engages in the shock coil up to the joining side of the compensating hose section.
Thereby, the parting point between the electrode body and the compensating hose section is placed in an advantageous manner underneath the shock coil, which is beneficial for forming an ideally homogenous, isodiametric electrode device. The diameter-reduced steps of the electrode body can be machined, fir example, by milling, but also by grinding, laser ablation, and the like.
The transfer point between the compensating hose section and the electrode body is particularly protected if the gaps between the hose section and the shock coil are filled, for example, with a grouting agent.
If the electrode device comprises a centrally guided, elastic supply line and, in particular, a coiled line, it is provided as a further preferred embodiment that the compensating hose section includes a central, straight and continuous lumen for this elastic supply line. Thus, the compensating hose section can be widely used for a multiplicity of different supply line configurations.
Further preferred embodiments relate to the material selection and corresponding provision of the compensating hose section which can consist of, for example, silicone rubber. Manufacturing can be carried out by, for example, extrusion or injection molding of liquid silicone rubber.
When using a cover sleeve for the parting point, it is advantageous in terms of the material to produce the compensating hose section from silicone rubber or silicone polyurethane copolymer and to produce the cover sleeve from the last mentioned material or from polyurethane. The last mentioned materials show a good abrasion resistance which is in particular relevant for the outer cover sleeve. Of course, other materials having similar properties are contemplated.
Finally, a pitch of the helically shaped receptacles in the compensating hose section which corresponds to the 3- to 5-fold of the outer diameter of the compensating hose section has been found to be advantageous with regard to a compensation of the bending loads and a corresponding reduction of the internal friction. Thereby, the extent of the elongation of the supply lines in the region of the compensating section is limited to an acceptable level.
Further features, aspects, objects, advantages, and possible applications of the present invention will become apparent from a study of the exemplary embodiments and examples described below, in combination with the figures, and the appended claims.
Further features, details and advantages of the present invention arise from the following description of exemplary embodiments based on the attached drawings. In the figures:
As is apparent from
The other supply lines 2, which are only indicated in
In the parting point T between the two sections 1.1, 1.2 of the electrode body 1, a compensating hose section 7 is inserted which has receptacles 8 in the form of lumina corresponding to the lumina 3. As not explicitly illustrated in
Apart from that,
Between the two shock coils 4, 5 remains an intermediate space 15 in which a cover sleeve 16, illustrated with a dashed line in
Corresponding to the three lumina 3 in the electrode body 1, the compensating hose section 7 also has three groove-shaped receptacles 8 which each have a pitch H that corresponds approximately to the 4-fold of the outer diameter DA of the compensating hose section 7 in
It will be apparent to those skilled in the art that numerous modifications and variations of the described examples and embodiments are possible in light of the above teachings of the disclosure. The disclosed examples and embodiments are presented for purposes of illustration only. Other alternate embodiments may include some or all of the features disclosed herein. Therefore, it is the intent to cover all such modifications and alternate embodiments as may come within the true scope of this invention, which is to be given the full breadth thereof. Additionally, the disclosure of a range of values is a disclosure of every numerical value within that range.
This patent application claims the benefit of co-pending U.S. Provisional Patent Application No. 61/599,429, filed on Feb. 16, 2012, which is hereby incorporated by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 61599429 | Feb 2012 | US |
