ELECTRICALLY CONDUCTIVE CONNECTION ELEMENT FOR A TEMPORARY ELECTRICALLY CONDUCTIVE CONNECTION TO AN ELECTRICAL CONSUMER

Abstract

An electrically conductive connection element for a temporary electrically conductive connection to an electrical consumer, in particular an external pacemaker, which is implanted in the living tissue of a patient, may have at least one biocompatible and bioresorbable electrical conductor strand in the form of an individual wire or a multifilament formed by multiple wires. The at least one electrical conductor strand is surrounded by at least one biocompatible and bioresorbable polymer or is embedded in a matrix formed by the polymer.

Claims

1-14. (canceled)

15. An electrically conductive connection element for a temporary electrically conductive connection to an electrical consumer comprising an external pacemaker, implanted in the living tissue of a patient and consisting of at least one biocompatible and bioresorbable electrical conductor strand in the form of a single wire or of a multifilament formed from a plurality of wires, wherein the at least one electrical conductor strand is surrounded by at least one biocompatible and bioresorbable polymer or is embedded therein in a matrix formed by the polymer.

16. The connection element in accordance with claim 15, wherein the at least one electrical conductor strand is formed from molybdenum, tungsten, or an Mo or W based alloy.

17. The connection element in accordance with claim 15, wherein the at least one electrical conductor strand is formed from a Mo base alloy having at least 50 atomic weight % Mo and at least one of the alloy elements selected from W, Re, V, Nb, Ta, Hf, Mn and Fe; or in that the at least one electrical conductor strand is formed from a W base alloy having at least 50 atomic weight % W and at least one of the alloy elements selected from Mo, Re, V, Nb, Ta, Hf, Mn and Fe.

18. The connection element in accordance with claim 15, wherein the diameter of single wires with which the at least one electrical conductor strand is formed is in the range between 3 .Math.m and 50 .Math.m, preferably in the range between 10 .Math.m and 30 .Math.m.

19. The connection element in accordance with claim 15, wherein the diameter of single wires with which the at least one electrical conductor strand is formed is in the range between 10 .Math.m and 30 .Math.m.

20. The connection element in accordance with claim 15, wherein the at least one biocompatible and bioresorbable polymer is formed on the basis of polylactide, polyglycolide, poly(lactide-co-glycolide) or polycaprolactone.

21. The connection element in accordance with claim 15, wherein the at least one biocompatible and bioresorbable polymer is used as a homopolymer or as a copolymer or as a mixture of different ones of these polymers.

22. The connection element in accordance claim 15, wherein the at least one electrical conductor strand is surrounded by or embedded in a first inner layer formed by a polymer A and is surrounded by a second outer layer formed by a polymer B.

23. The connection element in accordance with claim 22, wherein the polymer B is degraded over a longer time period than the polymer A or has a delayed start of the degradation in comparison with polymer A.

24. The connection element in accordance with claim 22, wherein at least one electrical conductor strand is wound around a central core formed from polymer A and the first inner layer is formed on the surface of the core of polymer A provided with the electrical conductor strand and the first inner layer is in turn surrounded by an outer layer of polymer B.

25. The connection element in accordance with claim 22, wherein at least one further electrical conductor strand is wound on an outer surface of the first inner layer and at least one second inner layer having the polymer A is formed on the surface of the first inner layer having the at least one further electrical conductor strand and is in turn surrounded by the outer layer of the polymer B.

26. The connection element in accordance with claim 22, wherein a respective layer of polymer B is formed between the at least two inner layers that each surround at least one electrical conductor strand and are formed from polymer A.

27. The connection element in accordance with claim 15, wherein at least two electrical conductor strands having different functions are arranged coaxially or cordially with one another in at least one inner layer that is formed by polymer A.

28. The connection element in accordance with claim 27, wherein at least two electrical conductor strands are anodic and cathodic electrical conductors or are measurement, stimulation, and defibrillation probes.

29. The connection element in accordance with claim 15, wherein regions of the connection element that are provided for electrical contact with the living tissue are modified at their surfaces; and in that at least a portion of the at least one electrical conductor strand is kept free of polymer in these regions.

30. The connection element in accordance with claim 29, wherein at least the polymer-free regions of the at least one electrical conductor strand of an Mo or W base material are provided with a coating of a second Mo or W base material or from a bioresorbable conductive oxide, nitride, or carbide on a Mo or W base.

Description

[0026] There are shown:

[0027] FIG. 1 in a schematic form, a connection line with a connected externally arranged consumer;

[0028] FIG. 2 a sectional representation through an example of a connection element;

[0029] FIG. 3 a sectional representation through a second example of a connection element; and

[0030] FIG. 4 a perspective representation of a third example of a connection element.

[0031] FIG. 1 shows a schematic representation of the arrangement for a temporary supply of a patient with a pacemaker as an external consumer 4. The electrically conductive connection element 1 consists of a line 2 and a polymer-free electrode region 3 and establishes a temporary electrically conductive connection to the electrical consumer 4 that is in particular an external pacemaker. In the case of application in accordance with the invention, the connection element 1 has been partially implanted in a patient so that at least the polymer-free electrode region is in contact with the heart tissue of the patient. The electrical consumer 4 is outside the body of the patient.

[0032] An example of a unipolar electrically conductive connection element 1 to be atrially anchored is shown in FIG. 2.

[0033] FIG. 2 shows a schematic sectional representation through an electrically conductive connection element 1 in a preferred embodiment for this purpose. This embodiment consists of metallic conductor strands 6 being wound around a core 5 that is formed from a polymer A that can be degraded in a short time. The conductor strands 6 are embedded in a first inner layer 7. The first inner layer 7 consists of the bioresorbable polymer A from which the core 5 is also formed. An outer layer 8 that is formed from a polymer B that is degradable more slowly in comparison with polymer A or from a polymer B that has a delayed start of the degradation in comparison with polymer A completely externally surrounds the first inner layer 7. The kind and design of the outer layer 8 of polymer B is selected such that the metallic conductor strand 6 is electrically insulated toward the surrounding body tissue for the intended time period of the connection to an eternal consumer 4 of a few days up to some weeks. The outer layer 8 of polymer B is subsequently degraded and exposes the first inner layer 7. The first inner layer 7, the conductor strands 6, and the core 5 dissolve in the body within a short time due to the higher degradation rate of polymer A and due to the preferred design of the conductor strands as very thin wires.

[0034] The metallic conductor strands 6 are formed from molybdenum wires having a circular cross-section and a diameter of 20 .Math.m. The production of the wires takes place by wire drawing. 18 to 20 of these wires are wound around a central monofilament as a core 5 having a diameter of 100 .Math.m. The central monofilament is formed from polylactide (PLA) having a molecular mass of 10,000 Da and reaches a high degradation rate under physiological conditions, designated as polymer A. This arrangement is coated with a first inner layer 7 having a thickness of 30 .Math.m and composed of the same polymer A so that the molybdenum wires are completely surrounded by polymer A. This arrangement is subsequently coated with an outer layer 8 of 20 .Math.m thickness and composed of polylactide having a molecular mass of 20,000 Da and a smaller degradation rate (polymer B). The outer layer 8 formed from polymer B surrounds the polymer A disposed thereunder and the conductor strands 6 over all sides and over the total length of the line 2. The electrode region 3 in which the metallic conductor strands 6 are exposed and that is provided for direct contact with the heart tissue is excluded from this.

[0035] The total outer diameter of this electrically conductive connection element 1 amounts to approximately 200 .Math.m.

[0036] A premature contact of the conductor strands 6 with the surrounding tissue and an accompanying loss of function or a loss of the security of the connection element 1 is prevented by the outer layer 8 of polymer B that degrades over a longer time period.

[0037] As soon as the polymer B has degraded, the polymer A disposed thereunder swiftly dissolves. The very thin, now isolated molybdenum wires are likewise degraded very fast due to corrosion procedures.

[0038] A bipolar coaxially wound electrically conductive connection element 1 is shown in an embodiment in FIG. 3.

[0039] The metallic conductor strands 6 and 9 are formed from molybdenum wires having a circular cross-section and a diameter of 20 .Math.m. The production of the wires takes place by wire drawing. 18 to 20 of these wires are wound around a central monofilament having a diameter of 50 .Math.m and form the anodic conductor. The central monofilament is formed as a core 5 from polylactide (PLA) having a molecular mass of 10,000 Da and a high degradation rate under physiological conditions, designated as polymer A. This winding is coated with a first inner layer 7 having a thickness of 50 .Math.m and composed of the same polymer A so that the molybdenum wires are completely surrounded by polymer A. A further 18 - 20 molybdenum wires having diameters of 20 .Math.m are wound onto this arrangement as second metallic conductor strands 9 and form the cathodic conductor. A second inner layer 10 of polymer A of a thickness of 30 .Math.m is applied to this second winding. This arrangement is subsequently coated with an outer layer 8 of 20 .Math.m thickness and composed of polylactide having a molecular mass of 20,000 Da and a smaller degradation rate (polymer B). The total outer diameter of this electrically conductive connection element 1 amounts to approximately 250 .Math.m.

[0040] A premature contact of the conductor strands 6 and 9 with the surrounding tissue and an accompanying loss of function or a loss of the security of the pacemaker line is prevented by the outer layer 8 of polymer B that degrades over a longer time period.

[0041] As soon as the polymer B has degraded, the polymer A disposed thereunder swiftly dissolves. The very thin, now isolated molybdenum wires are likewise degraded very fast due to corrosion procedures.

[0042] FIG. 4 shows a schematic representation of a connection element 1 having a modified polymer-free electrode region 3.

[0043] Reference numerals 5, 6, 7, and 8 refer to the same components of the connection line as are shown in FIG. 2. The coating 11 of the conductor strands 6 consists of a biocompatible, likewise bioresorbable and in this respect less oxidation sensitive metallic connection on a Mo or W base than the conductor strands 6 themselves. Possible application methods are inter alia a galvanic coating, chemical vapor deposition, plasma coating, and diffusion annealing. In a further embodiment, the coating 11 can be formed from bioresorbable, conductive oxides, nitrides, or carbides of the material of the conductor strands 6. These oxides, nitrides, or carbides can e.g. be obtained by a heat treatment of the electrical conductor strands 6 or also 9 by high temperature oxidation, nitration, or carbonization in an atmosphere rich in oxygen, nitrogen, or carbon.