IMPLANTABLE ELECTRODE DEVICE

Abstract

An implantable electrode device, in particular an ICD electrode device, comprises an electrode main body and at least one electrode situated thereon, the electrode including a wire material forming undercuts and/or intermediate spaces between its wires, such as a wire braid or an open wire coil. A medication depot filling is introduced into the under-cuts and/or intermediate spaces.

Description

Further features, advantages, and details of the present invention result from the following description of exemplary embodiments on the basis of the attached drawing.

FIG. 1 shows a detail side view of an ICD electrode device,

FIG. 2 shows a cross-section of the electrode device along section line A-A in FIG. 1,

FIG. 3 shows a detail top view of a planar defibrillation electrode, and

FIG. 4 shows a section along section line B-B in FIG. 3 of the defibrillation electrode.

FIGS. 1 and 2 show an ICD electrode device, which is implantable in the heart, having an elongate, tubular electrode body 1. This has a carrier tube 2 as a core, in which multiple lumens 3 run for the passage of the electric supply lines 4 for the shock and stimulation electrodes of the ICD electrode device, which are not shown in greater detail in FIGS. 1 and 2.

An open wire coil 6 is wound between two outer tube sections 5 on the carrier tube 2, which comprises externally concavely bulging flat wire material 7. Helical intermediate spaces 8 are left open between the individual turns of the wire coil 6, which are completely filled up by a medication depot filling 9. Therefore, there are no undercuts on the surface of the electrode body in the area of the shock electrode 10, though the crowned exteriors of the flat wire material 7 may protrude somewhat.

As shown in FIG. 2, the carrier tube 2 has longitudinally axially running hollow grooves 11 in the area of the shock electrode 10, into which the medication depot filling 9 extends.

The latter comprises—as already noted above—a biocompatible polymer matrix material, such as silicone, in which a medicinal active ingredient, such as heparin, is embedded. The active ingredient may escape from the plastic material when impinged by bodily fluid and—in the case of heparin—provide an anticoagulant effect.

The medication depot filling 9 may be formed, for example, by mixing the medicinal active ingredient into the liquid silicone carrier material and then introducing this filling material into the intermediate spaces 8 and the undercuts formed by the hollow grooves 11 and then curing the filling material.

As an alternative to this, the medication depot filling 9 may be produced by introducing the liquid carrier material into the intermediate spaces 8 and hollow grooves 11, curing this material, and introducing the medicinal active ingredient into openings of the cured filling material. The latter may be formed already during the curing by appropriate shaping, by mechanical processing, or by dissolving out a soluble foreign material distributed in the filling material. The medicinal active ingredient may be introduced by immersing the shock electrode 10 having the cured filling material into a medication solution or suspension, or by inserting particles or threads containing active ingredient into the openings produced.

The embodiment shown in FIGS. 3 and 4 represents a planar defibrillation electrode 12, in which a wire braid 14 is fixed over the medication depot filling 9′ on a flexible, leaf-shaped carrier 13. The wire braid 14 is made of woven around wire material 15. The intermediate spaces 8 between the crossing wires and the undercut areas 16 lying under the wires are closed by the medication depot filling 9′. The wire braid 14 is embedded on its rear side in the medication depot filling 9′ in such a way that the latter produces the fixing of the wire braid 14 on the carrier 13.

The statements made in connection with FIGS. 1 and 2 apply for the production and build up of the medication depot filling 9′ of FIGS. 3 and 4, so that further explanations are unnecessary.

Claims

1. An implantable electrode device comprising an electrode main body having: a. at least one electrode situated on the electrode main body, the electrode including one or more leads with at least one of (1) undercuts about the leads, and(2) intermediate spaces between the leads,b. a medication depot filling in the undercuts and/or intermediate spaces, wherein the medication depot filling contains a releasable medicinal active ingredient.

2. The electrode device of claim 1 wherein the medication depot filling includes a flexible plastic carrier material wherein the medicinal active ingredient is distributed.

3. The electrode device of claim 1 wherein the medication depot filling at least partially surrounds the leads to prevent the definition of any concavities between each lead and the medication depot filling.

4. The electrode device of claim 1 wherein the leads are at least partially embedded within the medication depot filling.

5. The electrode device of claim 1 wherein the leads are defined by a braid.

6. The electrode device of claim 1 wherein the leads are defined by a coil.

7. The electrode device of claim 1 wherein the medication depot filling is a biocompatible polymer matrix material.

8. The electrode device of claim 7 wherein the medication depot filling includes one or more of a. silicone andb. polyurethane.

9. The electrode device of claim 1 wherein the medicinal active ingredient in the medication depot filling includes at least one of: a. an antiinflammatory agent,b. an anticoagulant agent, and/orc. an antiproliferative agent.

10. The electrode device of claim 1 wherein the medication depot filling contains a biodegradable component.

11. The electrode device of claim 1 wherein the medication depot filling is formed by the steps of: a. mixing a medicinal active ingredient into a liquid carrier material;b. introducing the mixture into the undercuts and/or intermediate spaces; andc. curing the mixture.

12. The electrode device of claim 1 wherein the medication depot filling is formed by the steps of: a. introducing a liquid carrier material into the undercuts and/or intermediate spaces;b. curing the carrier material into an at least semi-solid state; andc. introducing the medicinal active ingredient into the cured carrier material.

13. The electrode device of claim 12 wherein the cured carrier material has openings defined therein, the openings being formed by at least one of the steps of: a. shaping the openings into the carrier material during curing;b. forming the openings into the cured carrier material; andc. dissolving matter distributed within the carrier material.

14. The electrode device of claim 12 wherein the medicinal active ingredient is introduced into the cured carrier material by at least one of the steps of: a. immersing the filling material in a medication solution or suspension; andb. inserting particles or threads containing active ingredient into openings in the cured carrier material.

15. An implantable electrode device having an electrode main body with: a. a medication depot filling on a surface of the electrode main body, wherein the medication depot filling includes a medicinal active ingredient;b. an electrical lead at least partially situated on the surface of the electrode main body, wherein: (1) at least a portion of the electrical lead abuts the medication depot filling, and(2) less than half of the surface area of the electrical lead is exposed on the surface of the electrode main body.

16. The implantable electrode device of claim 15 wherein the electrical lead is at least substantially embedded within the surface of the electrode main body, wherein less of the electrical lead extends above the surface of the electrode main body than below the electrode main body.

17. The implantable electrode device of claim 15 wherein an angle defined by the adjoining surfaces of the electrical lead and the medication depot filling is greater than 90 degrees at all areas wherein the electrical lead abuts the medication depot filling.

18. An implantable electrode device having an electrode main body with: a. a surface at least partially defined by a medication depot filling, wherein the medication depot filling includes a medicinal active ingredient;b. an electrical lead substantially embedded within the surface of the electrode main body, wherein less of the electrical lead extends above the surface of the electrode main body than below the electrode main body.

19. The implantable electrode device of claim 18 wherein less than half of the surface area of the electrical lead is exposed on the surface of the electrode main body.

20. The implantable electrode device of claim 18 wherein an angle defined by any adjoining surfaces of the electrical lead and the medication depot filling is greater than 90 degrees at all areas wherein the electrical lead extends above the surface of the electrode main body.