ELECTRODE HEAD AND ELECTRODE LINE

Abstract

An electrode head of an implantable electrode line, including an elongate housing which has a longitudinal axis and includes at least two housing parts, which are cylinder-segment-shaped at least in portions and are fixedly joined together.

Claims

1-16. (canceled)

17. An electrode head of an implantable electrode line, comprising: an elongate head housing which has a longitudinal axis and comprises two shell parts, the first shell part comprises a cylindrical outer contour in the proximal region and a half-cylindrical outer contour in the distal region, the second shell part has a half-cylindrical outer contour, and a dividing plane parallel to the longitudinal axis, the first and the second shell parts are fixedly joined together, wherein the elongate head housing has a plurality of chambers delimited by transverse wall pieces, each transverse wall piece shaped in a form of a segment of a circle, each transverse wall piece extending from at least one inner surface of the two shell parts and having a central aperture when the two shell parts are fixedly joined together so that the chambers are separated from one another by the transverse wall pieces.

18. The electrode head as claimed in claim 17, wherein the two shell parts of the head housing are welded or adhesively bonded to one another.

19. The electrode head as claimed in claim 17, wherein the two shell parts of the head housing are held together by one or two rings which can be slid over the cylinder parts without welding or adhesively bonding the two shell parts to one another

20. The electrode head as claimed in claim 17, wherein at least a portion of the housing comprises metal stamped parts.

21. The electrode head as claimed in claim 17, wherein at least a portion of the housing comprises injection molded parts made of PEEK.

22. The electrode head as claimed in claim 17, wherein at least a portion of the housing has a stepped outer diameter, such that in a proximal portion an outer diameter is smaller than in a portion arranged distally in relation to the proximal portion.

23. The electrode head as claimed in claim 17, wherein the elongate head housing further comprises an open distal and/or proximal end.

24. The electrode head as claimed in claim 17, further comprising a drug storage region in a portion of an outer surface of the elongate head housing.

25. The electrode head as claimed in claim 24, wherein the drug storage region is annular and outer surfaces of the two shell parts joined together have a return corresponding to the dimensions of the annular drug storage region.

26. An electrode line comprising: an elongate flexible electrode line body; and an electrode head as claimed in claim 17 attached distally to the electrode line body.

27. The electrode line as claimed in claim 26, wherein the electrode head is attached by means of at least one resilient connection tube piece to the electrode line body.

28. The electrode line as claimed in claim 26, further comprising an active fixing element which is received in a distally arranged first chamber of the electrode head.

29. The electrode line as claimed in claim 28, wherein the fixing element is formed as a rotatable and displaceable helical coil.

30. The electrode line as claimed in claim 28, further comprising a ring seal which is arranged in at least one second chamber of the electrode head arranged proximally in relation to the first chamber.

31. The electrode line as claimed in claim 28, further comprising an X-ray contrast ring which is arranged in at least one second chamber of the electrode head arranged proximally in relation to the first chamber.

32. The electrode head as claimed in claim 17, wherein the plurality of chambers comprises three chambers.

Description

DESCRIPTION OF THE DRAWINGS

[0022] Advantages and expedient features of the present invention will also emerge from the following description of an exemplary embodiment(s) with reference to the drawings, in which:

[0023] FIG. 1 shows a perspective external view of an electrode head according to an embodiment of the invention;

[0024] FIGS. 2A-2B show, respectively, a perspective view of the internal design (FIG. 2A) and of the inner wall of a half-shell of the electrode head from FIG. 1; and

[0025] FIG. 3 shows a longitudinal section of the design of an electrode line provided with the electrode head according to FIGS. 1-2B (distal part).

[0026] FIGS. 4A (closed shell) and 4B (open shell) show perspective illustrations of an alternate screw electrode head according to an additional embodiment of the present invention.

[0027] FIG. 5 shows a cross-section view of the alternate screw electrode head shown in FIG. 4A.

[0028] FIG. 6 shows an interior view of the shell part of the alternate screw electrode head shown in FIG. 4B.

[0029] FIG. 7 shows a cross-sectional view of the alternate screw electrode head according to FIG. 5, with the shell part removed.

DETAILED DESCRIPTION

[0030] FIG. 1 shows a perspective illustration of a screw electrode head 1, which has a basic cylindrical shape, of an implantable pacemaker electrode line (see FIG. 3), of which the construction is shown in greater detail in FIGS. 2A-2B. At the distal end, the electrode head 1 has a rounded flange portion 1a of a first diameter, which is adjoined (in this order) by a first longer cylinder portion 1b of smaller diameter, a second longer cylinder portion 1c of larger diameter (which can be bigger, smaller or equal to the first diameter), and lastly a third longer cylinder portion 1d, again of reduced diameter again and also below the diameter of the first cylinder portion 1b. In addition, it can be seen that the electrode head 1 has an open distal end 1e, in which the distal end of a helical coil 3 can be seen. Furthermore, a continuous weld seam 1f can be seen and fixedly interconnects prefabricated half-shells 1.1 and 1.2 (not denoted separately here) of the electrode head 1 in an integrally bonded manner.

[0031] FIG. 2A shows the inner design of the electrode head 1, together with the first half-shell 1.1 of the head housing, and FIG. 2B shows the second half-shell 1.2 of the head housing, in each case again in a perspective illustration. For the sake of improved clarity, the above-referenced portions 1a to 1e of the outer contour of the head housing are not denoted again in FIGS. 2A-2B. It can be seen, however, that both half-shells 1.1, 1.2 have a division (naturally likewise in a half-shell-like manner) into three chamber segments 1.1A, 1.1B and 1.1C and 1.2A, 1.2B and 1.2C, respectively, adjoining one another in the longitudinal direction. The mentioned chamber segments are separated from one another by partition walls shaped primarily in the form of segments of a circle and having a central aperture, of which merely the more distal partition wall 1.1D of the first half-shell 1.1 can be seen in FIG. 2A, although both partition walls 1.2D and 1.2E can be seen in FIG. 2B.

[0032] When comparing the two drawings, it can be easily seen that the half-shells 1.1, 1.2 are not identical, but have different projections and returns or stops and centering means, both in the region of the distal flange and of two of the three stepped cylindrical regions and lastly also in the region of the partition walls. Inter alia, it is thus ensured that there are overlap regions of sufficient size in the wall of the head housing between the first and second half-shell so as to ensure high mechanical stability and tightness of the rear region of the head housing.

[0033] It can be seen from FIG. 2A how the helical coil 3 fills the distal chamber 1A of the electrode head 1 in the retracted state in its entire length and surrounds, via its proximal end, a ram 5a of a fixing screw actuation shaft 5, to which it is fastened (not visible here) in an integrally bonded manner (for example, by means of welding). In the second chamber 1B, the fixing screw actuation shaft 5 is surrounded by a ring seal 7 and an X-ray contrast ring 9 in such a way that the periphery of the chamber 1B is largely filled. In the third chamber 1C, a contact sleeve 11 for electrically contacting the conductor coil (not shown here) of the electrode line body with the ram 5a or the helical coil 3 can be seen.

[0034] FIG. 3 shows a longitudinal sectional illustration of the distal end region of an electrode line 10 provided with the electrode head 1 according to FIGS. 1-2B. Besides the electrode head 1, of which the outer shape and design are shown in FIGS. 1-2B and are described further above, the electrode line 10 comprises an outer line body (not shown here) or outer tube, an outer conductor coil (likewise not illustrated here) for contacting a ring electrode 13, and an inner conductor coil 17 arranged within an inner tube 15. The fixing screw actuation shaft 5, already mentioned above, is in turn placed in the interior of said coil, and the contact sleeve 11, likewise already mentioned further above, is attached to the end of said shaft.

[0035] The mechanical connection and simultaneous seal between the electrode head 1 and the line body of the line 10 distally in relation to the ring electrode 13 is produced by an inner PTFE (polyetrafluoroethylene—Teflon) tube 19.1 and a substantially likewise tubular outer silicone connection piece 19.2. Whereas the PTFE tube 19.1 is arranged within the proximal chamber 1C of the electrode head 1 and extends beyond a distal region of the inner conductor coil 17, the silicone connection piece 19.2 surrounds a distal end portion of the ring electrode 13 as well as the outer wall of the proximal chamber 1C (or, on the basis of the external view, the proximal cylinder portion 1d) of the electrode head 1 and interconnects these. Suitably shaped fixing ring portions, or locking portions, in the inner wall of the silicone connection piece 19.2 or the outer wall of the PTFE tube 19.1, and optionally additional fixing rings or other fixing means, contribute to secure fixing of the interconnected parts in the longitudinal direction of the electrode line in a manner known per se.

[0036] Specific attention should be paid in FIG. 3 to the complete illustration of the ring seal 7, of which only a distal end-face portion can be seen in FIG. 2A. It can be seen that the outer contour of the ring seal 7 is stepped or chamfered a number of times. Furthermore, a hollow-cylindrical drug storage region 21 is illustrated here in the region of the distal cylinder portion 1B of the electrode head 1 and (again in a manner known per se) serves to store and continuously dispense, in an ongoing manner, an anti-inflammatory steroid when the electrode line is implanted. When the half-shells are already fixedly connected to the cylindrical electrode head 1, the drug store in the form of a hollow cylinder 21 is slid over and fastened in the distal region.

[0037] In the shown embodiment, the electrode head 1 is preferably manufactured from PEEK half-shells, however PU half-shells or housing parts formed from another polymer that can be used in implanted parts can also be manufactured alternatively. In principle, the manufacture from a biocompatible metal, such as, for example, titanium or a titanium alloy or high-grade steel, is also considered, wherein special design provisions have to be made, however, in order to ensure the radiopacity of the length by which the helical coil is screwed out, and specific spring ranges, which are not provided in the above-described embodiment, would possibly have to be provided.

[0038] The embodiment of the present invention is not limited to the above-described examples and high-lighted aspects, but the present invention can also be implemented in a large number of modifications within the capabilities of a person skilled in the art.

[0039] FIGS. 4A (closed shell) and 4B (open shell) show a perspective illustration of an alternative screw electrode head 101, which has a basic cylindrical shape of an implantable pacemaker electrode line, of which the construction is shown in greater detail in FIGS. 5-6. At the distal end, the electrode head 101 has a rounded flange portion 101a of a first diameter, which is adjoined (in this order) by a first longer cylinder portion 101b of smaller diameter, a second longer cylinder portion 101c of larger diameter (which can be bigger, smaller or equal to the first diameter), and lastly a third longer cylinder portion 101d, again of reduced diameter and also below the diameter of the first cylinder portion 101a. The second longer cylinder portion 101c of larger diameter can consist of three cylinder portions 101c′, 101c″ and 101c′″, where the diameter of the cylinder portions 101c′ and 101c′″ is smaller or equal compared to the diameter of the cylinder portion 101c″, but the diameter of the cylinder portion 101c′ is bigger than the diameter of the rounded flange portion 101a and also bigger than the diameter of the cylinder portion 101b. The diameter of the cylinder portion 101c′″ is bigger than the diameter of the cylinder portion 101d. In addition, it can be seen that the electrode head 101 has an open distal end 101e, in which the distal end of a helical coil 3 can be seen. Furthermore, a continuous interface 101f, i.e., a weld seam or groove, can be seen where the prefabricated first shell part 101.1 and the second shell part 101.2 of the electrode head 101 are put together.

[0040] FIG. 5 shows the inner design of the electrode head 101, together with the first shell part 101.1 and the second shell part 101.2 of the head housing, and FIG. 6 shows the second shell part 101.2 of the head housing, in each case again in a perspective illustration. For the sake of improved clarity, the above-referenced portions 101a to 101e of the outer contour of the head housing are not denoted again in FIGS. 5-6. It can be seen in FIG. 5, however, that the housing of the head 101, formed out of the shell parts 101.1, 101.2, has a division (naturally likewise in a half-shell-like manner) into three chamber segments 101A, 101B and 101C, adjoining one another in the longitudinal direction. The mentioned chamber segments are separated from one another by partition walls shaped primarily in the form of segments of a circle or a ring and having at least a central aperture, of which both partition walls 101D and 101E can be seen in FIG. 5. In FIG. 6, merely the more distal partition wall 101D can be seen, because it is connected to the second shell part 101.2. The two shell parts 101.1 and 101.2 can be held together by one or two rings which can be slid over the cylinder parts 101c′ and 101c′″. The rings can preferably manufactured from PEEK, PU or from another polymer that can be used in implanted parts. In principle, the manufacture from a biocompatible metal, such as, for example, titanium or a titanium alloy such as Platinum/iridium or high grade steel, is also considered. In addition, at least one of the rings can be an X-ray contrast ring, consisting at least in parts of a radiopaque material such as, i.e., Platinum/iridium. In addition or alternatively, the housing parts, in particular, the first and second shell parts 101.1 and 101.2, of the head housing are expediently welded or adhesively bonded together.

[0041] When comparing the two drawings, it can be easily seen that the half-shells 101.1, 101.2 are not identical, but have different projections and returns or stops and centering means, both in the region of the distal flange and of two of the three stepped cylindrical regions and lastly also in the region of the partition walls. Inter alia, it is thus ensured that there are overlap regions of sufficient size in the wall of the head housing between the first and second half-shell so as to ensure high mechanical stability and tightness of the rear region of the head housing. Due to the asymmetric form of the two shell parts 101.1 and 101.2, it is sufficient if the two shell parts 101.1 and 101.2 are held together by one or two rings which can be slid over the cylinder parts 101c′ and 101c′″. In this case the housing parts, in particular, the first and second shell part 101.1 and 101.2, of the head housing do not necessarily need to be welded or adhesively bonded together. It can be seen from FIG. 6, that the second shell part has a pin 12 so that the helical coil acting as a fixation screw can be rotated out from the head housing in distal direction.

[0042] It can be seen from FIGS. 5 and 7 how the helical coil 3 fills the distal chamber 101A of the electrode head 101 in the retracted state in its entire length and surrounds, via its proximal end, a ram 5a of a fixing screw actuation shaft 5, to which it is fastened (not visible here) in an integrally bonded manner (for example, by means of welding). In the second chamber 101B, the fixing screw actuation shaft 5 is surrounded by a ring seal 7 in such a way that the periphery of the chamber 101B is largely filled. In the third chamber 101C, a contact sleeve 11 for electrically contacting the conductor coil (not shown here) of the electrode line body with the ram 5a or the helical coil 3 can be seen.

[0043] One or more of the helical coil 3, the fixing screw actuation shaft 5 and the ram 5a of the fixing screw actuation shaft 5 can consist at least in part of a radiopaque material. In case both rings are made as X-ray contrast rings and at least the ram 5a of the fixing screw actuation shaft 5 consists at least in part of a radiopaque material, it is possible to inspect how far the helical coil acting as a fixation screw has been rotated out from the head housing in distal direction.

[0044] 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.