U.S. patent application number 14/958970 was filed with the patent office on 2016-03-24 for implantable electrode lead.
The applicant listed for this patent is BIOTRONIK SE & Co. KG. Invention is credited to Klaus Bartels, Gernot Kolberg, Jochen Palm.
Application Number | 20160081568 14/958970 |
Document ID | / |
Family ID | 45440213 |
Filed Date | 2016-03-24 |
United States Patent
Application |
20160081568 |
Kind Code |
A1 |
Kolberg; Gernot ; et
al. |
March 24, 2016 |
Implantable Electrode Lead
Abstract
An implantable electrode lead for transmitting electrical
impulses to excitable bodily tissue and/or for transmitting
electrical signals tapped at bodily tissue to a detection unit. The
electrode lead including a distal electrode, a proximal electrode
connector, and an electrode supply lead which connects the
electrode, or each electrode, to the electrode connector, or each
electrode connector, and extends in a lead body, wherein the lead
body includes a hinged alignment of hard elements.
Inventors: |
Kolberg; Gernot; (Berlin,
DE) ; Palm; Jochen; (Mahlow, DE) ; Bartels;
Klaus; (Berlin, DE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
BIOTRONIK SE & Co. KG |
Berlin |
|
DE |
|
|
Family ID: |
45440213 |
Appl. No.: |
14/958970 |
Filed: |
December 4, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13338433 |
Dec 28, 2011 |
|
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14958970 |
|
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61432212 |
Jan 13, 2011 |
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Current U.S.
Class: |
600/373 ;
607/116 |
Current CPC
Class: |
A61N 1/05 20130101; A61B
5/04 20130101; A61B 5/6846 20130101; A61B 2562/187 20130101; A61B
2562/222 20130101 |
International
Class: |
A61B 5/04 20060101
A61B005/04; A61N 1/05 20060101 A61N001/05; A61B 5/00 20060101
A61B005/00 |
Claims
1-24. (canceled)
25. An implantable electrode lead for transmitting electrical
impulses to excitable bodily tissue or electrical signals tapped at
bodily tissue to a detection unit or combinations thereof, the
electrode lead comprising: a distal electrode; a proximal electrode
connector; a lead body; and an electrode supply lead which connects
the distal electrode, or each electrode, to the electrode
connector, or each electrode connector, and/or is used to transmit
electrical shocks and/or to control sensors, and which extends in
the lead body, wherein the lead body comprises a hinged alignment
of closely interspaced hard elements configured and spaced for
protecting the lead body and the electrode supply lead from
radially acting forces, wherein the distal electrode comprises a
ring electrode situated as a ring around an outer circumference of
one of the hard elements, wherein at least the one hard element
includes a radial recess into which the electrode supply lead is
accommodated, the radial recess sized smaller than the electrode
supply lead such that the electrode supply lead accommodated
therein is forced into mechanical and electrical connection with an
inner wall of the ring electrode.
26. The electrode lead according to claim 25, wherein sections
which are compressible or bendable in a flexibly yielding or
flexurally resilient manner are inserted into the hinged alignment
of hard elements.
27. The electrode lead according to claim 25, wherein sections
which are compressible and bendable in a flexibly yielding or
flexurally resilient manner are inserted into the hinged alignment
of hard elements.
28. The electrode lead according to claim 25, wherein the hinged
alignment of hard elements is enclosed by a flexibly yielding
material, at least in sections.
29. The electrode lead according to claim 25, wherein a flexible
tube is drawn over the alignment of hard elements, at least in
sections.
30. The electrode lead according to claim 25, wherein the hard
elements contain at least one of the following materials: a metal,
a ceramic, a glass, and a plastic.
31. The electrode lead according to claim 30, wherein: the metal
comprises platinum, tantalum, iridium, palladium, stainless steel,
gold, or MP35N, the ceramic comprises Al2O3, ZrO2, TiO2, MgO, ZnO,
Al2O3+TiO2, BaO+TiO2, SiC, BeO, AlN, HfC, TaC, TiN, BN, B4C, WC or
Si3N4, and the plastic comprises PEEK, silicone, a copolymer, a
polyimide, PA, high-density polyethylene or polysulphone, or
variants of the aforementioned plastics filled with fibers or
nanoparticles.
32. The electrode lead according to claim 25, wherein at least a
few of the hard elements are directly adjacent to one another and
include end faces that face one another, wherein the end faces are
shaped in a manner such that tilting about a longitudinal axis of
the electrode lead, which is limited relative to a minimal bending
radius, is possible.
33. The electrode lead according to claim 25, wherein at least a
few of the hard elements are directly adjacent to one another and
are directly interconnected to each other in a tension-resistant
manner using joint sections.
34. The electrode lead according to claim 25, wherein first and
second hard elements which are differently shaped and additionally,
or alternatively, differently sized, are enmeshed in a hinged
manner.
35. The electrode lead according to claim 25, further comprising
soft elements, wherein the hard and soft elements are enmeshed in a
hinged manner and provided in alternating alignment.
36. The electrode lead according to claim 35, wherein the hard and
soft elements are formed as an integral tube, wherein the hard
elements are formed by rigid sections of the tube, between which
the soft elements present which are defined by recesses formed in a
wall of the tube.
37. The electrode lead according to claim 36, wherein the recesses
comprise spiral extending recesses.
38. The electrode lead according to claim 25, wherein at least one
of the hard elements comprises a fixation element for mechanically
fixing the electrode lead in an implanted state.
39. The electrode lead according to claim 25, wherein the hard
elements include at least one central or one off-center lumen, or
combinations thereof, for receiving additional electrode supply
lines.
40. The electrode lead according to claim 25, wherein at least one
of the hard elements contains an electrical or electronic component
in a cavity provided therein configured to electrically and
mechanically connect to the electrode supply lead.
41. The electrode lead according to claim 40, wherein the
electrical or electronic component comprises an electrode, a coil,
a sensor element, a capacitor, or an active electronic component or
an electronic circuit.
42. An implantable electrode lead for transmitting electrical
impulses to excitable bodily tissue or electrical signals tapped at
bodily tissue to a detection unit or combinations thereof, the
electrode lead comprising: a lead body comprising a hinged
alignment of closely interspaced hard elements; a ring electrode
situated as a ring around an outer circumference of one of the hard
elements; a proximal electrode connector; an electrode supply lead
which connects the ring electrode to the proximal electrode
connector and/or is used to transmit electrical shocks and/or to
control sensors, and which extends in the lead body, wherein at
least the one hard element includes a radial recess into which the
electrode supply lead is accommodated, the radial recess sized
smaller than the electrode supply lead such that the electrode
supply lead accommodated therein is forced into mechanical and
electrical connection with an inner wall of the ring electrode.
43. The electrode lead according to claim 42, wherein at least a
few of the hard elements are directly adjacent to one another and
include end faces that face one another, wherein the end faces are
shaped in a manner such that tilting about a longitudinal axis of
the electrode lead, which is limited relative to a minimal bending
radius, is possible.
44. The electrode lead according to claim 42, wherein the hard
elements include at least one central or one off-center recess or
lumen, or combinations thereof, for receiving additional electrode
supply lines.
Description
RELATED APPLICATION
[0001] This patent application claims the benefit of co-pending
U.S. Provisional Patent Application No. 61/432,212, filed on Jan.
13, 2011, which is hereby incorporated by reference in its
entirety.
TECHNICAL FIELD
[0002] The present disclosure relates to an implantable electrode
lead for transmitting electrical impulses to excitable bodily
tissue and/or for transmitting electrical signals tapped at bodily
tissue to a detection unit. The implantable electrode lead
generally includes a distal electrode, a proximal electrode
connector, and an electrode lead which connects the electrode or
each electrode, or is used to transmit electrical shocks or to
control sensors, and which extends in a lead body.
BACKGROUND
[0003] Such electrode leads, which are used to transmit (e.g.,
stimulation impulses from cardiac pacemakers to the heart, or
possibly action potentials that occur at the heart to the cardiac
pacemaker, or the shock impulses of an implanted cardioverter to
the heart, and possibly action potentials tapped at the heart to
the cardioverter, or which are used to stimulate regions of the
brain or nerves, or to transmit electrical signals tapped at the
brain/nerve regions to a detection and evaluation device, are used
on a large scale for clinical applications.
[0004] Of the numerous fields of application for electrode leads,
there are a few in which they are exposed, at least in subsections,
to high mechanical loads which can impair the functionality or even
disable the electrode lead entirely during long-term use. Examples
thereof include, but are not limited to, cardiac pacemaker
electrode leads, one or more supply leads between an implanted
control device and one or more implantable sensors, and ICD
electrodes that have one or more very large areas for the
application of very high current pulses into the tissue over a
large surface area.
[0005] First, excess length of the electrode is enclosed in the
pacemaker pocket. A tenacious connective-tissue membrane grows
around the structure. At the points at which the electrode comes in
contact with the housing or intersects other electrode sections,
high pressure loads can be placed on the lead body since the
connective tissue growing around it does not allow the electrode to
yield. Proceeding there from, the electrode extends generally
through the region between the clavicle and the first costal arch.
If the electrode is in an unfavorable position, it can become
pinched.
[0006] Extensive developmental work in the past resulted in various
possible solutions to this problem. Electrode leads are designed to
be highly flexible. The hard materials, such as, for example,
metal, that are used for the supply leads are configured to be
highly flexible. Wires are wound into coils or are woven very
thinly to form ropes. Plastics that are soft and as elastic as
possible are used as insulators that offer the least possible
resistance to the movements of the electrode.
[0007] The known solutions have not proven to be entirely
satisfactory in practice. For example, if radial pressure is
applied, the insulation material yields in a manner such that the
pressure ultimately acts on the supply leads. Moreover, the
pinching of the insulation material stresses the plastic. The
stress can cause the material to degrade or directly cause it to
yield mechanically. The insulation wears off, bursts, or degrades.
Initially, the insulation is breached. Bodily fluid can penetrate
the electrode and close electrolyte bridges between the leads.
Shunts or short circuits can negatively affect therapy. In the
worst case, however, the supply leads break and therapy fails.
Furthermore, it can not be ruled out that a broken electrode body
will cause further damage.
[0008] The problems addressed by the present description are
therefore that of providing an improved electrode lead which is
more resistant to substantially radially acting forces and
friction, at least in certain sections in particular, while
remaining as flexible as necessary.
[0009] The present inventive disclosure is directed toward
overcoming one or more of the above-identified problems.
SUMMARY
[0010] One or more problems are solved by an electrode lead having
the features of the independent claim(s). Further advantageous
developments are the subject matter of the dependent claims.
[0011] In this context, the term "hard elements" refers to separate
elements or even delimitable sections in the longitudinal extension
of a lead body, which are extremely resistant ("hard") to forces
that act radially or obliquely to the longitudinal axis of the
electrode lead and are short relative to the total length of the
electrode lead. According to the present disclosure, at least those
sections in the longitudinal extension of an electrode lead that
are typically exposed to strong mechanical loads of that type are
designed to be particularly resistant.
[0012] An electrode lead designed on the basis of the solution
according to the present description is substantially more stable
against mechanical loads to which it is exposed in practical
application. The radial compression and flexing forces being
applied are absorbed here by an additional shield, namely, the hard
elements. The functional components, i.e., the supply lead, which
is comprised of rope or coil or combinations thereof, and the
insulators, which are comprised of plastic, are limited in terms of
their actual function (namely, to conduct or insulate). In
conventional electrodes, due to the radial forces acting thereon,
these functional elements had to withstand various loads, such as,
for example, torsional moments, tensile forces, flexing forces, and
friction. An optimal embodiment of the solution according to the
present description also provides permanent protection against
unwanted movements of the electrode body. For example, relative
motions between the supply lead and the insulation can be
minimized.
[0013] Further aspects of embodiments of the present description
are the following, which represents a non-exhaustive list: [0014]
1. Materials for at least a portion of the hard elements can
be:
[0015] Metal: Platinum, tantalum, iridium, palladium, steel, MP35N,
gold, etc. [0016] Ceramic: Al2O3, ZrO2, TiO2, MgO, ZnO, aluminum
titanate (Al2O3+TiO2), barium titanate (BaO+TiO2), silicon carbide
(SiC), beryllium oxide (BeO), aluminum nitride (AlN), hafnium
carbide (HfC), tantalum carbide (TaC), titanium nitride (TiN),
boron nitride (BN), boron carbide (B4C), tungsten carbide (WC),
silicon nitride (Si3N4), etc. [0017] Glass: [0018] Plastic: PEEK,
silicone, various copolymers, polyimide, PA, high-density
polyethylene, polysulphone, or variants of the aforementioned
plastics filled with fibers or nanoparticles, etc. [0019] 2. The
hard elements alternate with elastic elements (sections). [0020] 3.
The quality of the elements changes along the extension of the
electrode. [0021] 4. The hard elements of the chain are
interconnected by an elastic material. [0022] 5. The elastic
material is applied by extrusion or coating or injection molding of
the chain. [0023] 6. The elements of the chain are enclosed in an
elastic material. [0024] 7. The supply lead body is enclosed in an
abrasion-resistant tube. [0025] 8. At least one coil or one
reinforcing wire extends in the core of the chain, e.g., in a lumen
[0026] 9. At least one rope extends in the core of the chain.
[0027] 10. The coil(s) or the rope(s) or combinations thereof are
insulated from one another and/or from the chain. [0028] 11. The
openings are asymmetrical (a core lumen need not be provided).
[0029] 12. The elements of the chain are insulators. [0030] 13. The
elements of the chain are semiconductors. [0031] 14. The elements
of the chain are conductive. [0032] 15. The shape of the elements
changes depending on the function. [0033] 16. Individual elements
have different lengths. [0034] 17. Individual elements have
different diameters. [0035] 18. Individuals elements of the chain
are designed as a ring electrode or can accommodate a ring
electrode. [0036] 19. Individuals elements of the chain are
designed as sensors or can accommodate sensors. [0037] 20.
Individuals elements of the chain are designed as coils or can
accommodate coils. [0038] 21. Individuals elements of the chain are
designed as capacitors or can accommodate capacitors. [0039] 22.
Individual elements of the chain contain electronic components,
analog or digital circuits or combinations thereof, accumulators,
batteries, antenna, transmitters, or receivers or combinations
thereof. [0040] 23. Individual elements of the chain are designed
as fixation elements or can accommodate fixation elements, which
are used to affix the electrode at the intended location thereof.
[0041] 24. The elements have openings for the eccentrically
extending supply leads, which define the path in which they extend.
[0042] 25. The eccentrically extending supply leads are disposed in
parallel to the axis of the electrode body. [0043] 26. The
eccentrically extending supply leads are coiled around the axis of
the electrode body. [0044] 27. The eccentrically extending supply
leads are coiled around the axis of the electrode lead, wherein the
slope of the coil changes along the electrode length, reverses
(winds in the opposite direction), or approaches infinity, i.e.,
extends in parallel. [0045] 28. The end faces (contact surfaces) of
the elements to the adjacent elements are designed in a manner
(e.g., flattened) such that the chain is easier to bend. [0046] 29.
The contact surfaces of the elements are designed in a manner such
that, if bent, the minimum bending radius of the chain is limited.
[0047] 30. The elements are designed in a manner such that the
degree of freedom of motion toward the adjacent elements is
limited. Elements perform joint functions (i.e., the chain no
longer bends in all directions at this transition of the chain
elements), wherein the elements designed as joints are designed
such that they can absorb tensile forces (a so-called "reaching
behind"). [0048] 31. The plane of motion toward the subsequent
element is rotated by an angle, e.g., of approximately 90.degree..
[0049] 32. The eccentrically extending supply leads are guided in
the joint plane from one element to the next (thereby minimizing
the motion of the lead relative to the element). [0050] 33. The
elements are injection molded onto a tube or are extruded thereon.
[0051] 34. The above-described elements are separated from each
other by special elements which function as joints. [0052] 35. The
elements are interconnected by integrated joints. [0053] 36. The
elements are made from a tube. [0054] 37. The elements are aligned
in a row, e.g., overlapped in a shingled formation. [0055] 38. The
sections of the tube are interconnected. [0056] 39. The tube is
made from one continuous piece, in particular, using, for example,
laser-beam cutting. [0057] 40. The type of chain changes along the
extension of the electrode. Segments of the electrode body are
designed as chains and others use traditional design principles of
the electrode body. [0058] Various other objects, aspects and
advantages of the present inventive disclosure can be obtained from
a study of the specification, the drawings, and the appended
claims.
DESCRIPTION OF DRAWINGS
[0059] Advantages and useful features of the present description
also result from the descriptive examples that follow, with
reference to the figures. They show:
[0060] FIG. 1 is a schematic representation of a conventional
implantable electrode lead.
[0061] FIG. 2 shows, in a perspective sectional view, an example of
a highly developed electrode lead comprising a plurality of supply
leads accommodated in one lead body.
[0062] FIG. 3 shows, in a perspective sectional view, a further
highly developed electrode lead comprising a plurality of supply
leads in a coaxial arrangement.
[0063] FIGS. 4A-4B and FIGS. 5A-5B each show schematic depictions
of an electrode lead designed according to the present description,
in a side view.
[0064] FIGS. 6A-6C each show, in schematic perspective sectional
views, a hard element of an embodiment of the electrode lead
according to the present description.
[0065] FIG. 7 is a schematic side view of a section of a further
electrode lead according to the present description.
[0066] FIG. 8 are perspective depictions of three hard elements of
an embodiment of the electrode lead shown in FIG. 7.
[0067] FIG. 9 is a perspective depiction of adjacently disposed,
hard elements of a further electrode lead according to the present
description.
[0068] FIG. 10 is a schematic side view of a further embodiment of
the present description.
[0069] FIG. 11 is a schematic perspective depiction of a section of
a further electrode lead according to the present description.
[0070] FIG. 12 is a schematic longitudinal sectional view of a
further embodiment of the present description, in which a hard
element also performs an electrical function.
[0071] FIG. 13 is a perspective view of a further embodiment of the
present description.
[0072] FIGS. 14A-14B are side views of a section of the electrode
body of a further electrode lead according to the present
description.
[0073] FIGS. 15A-15B are sketches of further embodiments of the
electrode lead according to the present description.
[0074] FIG. 16 is a sketch of a further embodiment of the present
description.
DETAILED DESCRIPTION
[0075] In the description of the various Figures that follow,
similar reference numerals are used for identical or
identically-acting parts or sections, and previous descriptions are
not repeated for subsequent Figures provided they refer to such
parts and no special circumstances exist. Embodiments of the
present disclosure are illustrated by way of example, and not by
way of limitation, in the Figures.
[0076] FIG. 1 is a schematic depiction of a bipolar electrode lead
1, on the distal end of which a point electrode 3a and a ring
electrode 3b are disposed. Two corresponding electrode contacts 5a
and 5b are provided on the proximal end thereof, each being
connected to the respective associated electrode 3a, 3b by a first
and a second supply lead 7a, 7b, respectively. The electrodes, 3a,
3b, electrode contacts, 5a, 5b, and supply leads 7a, 7b are
accommodated on or in a lead body 9, which typically comprises
multiple layers.
[0077] FIG. 2 shows, in a perspective sectional view having various
cutting planes, an electrode lead 201, in the case of which three
lumina 208a having a smaller diameter and an additional lumen 208b
having a larger diameter are provided in an inner tube 209a, which
is the core of a supply lead body 209. Each of the smaller lumina
208a contains an electrode supply lead 207a having a rope structure
which is provided with an insulating jacket comprised of, e.g.,
PTFE, ETFE or PI, and which is not labeled separately. A supply
lead coil 207b, which can accommodate a guide wire during
implantation to reinforce the electrode lead, extends in larger
lumen 208b. To improve the sliding and wear properties of lead body
209, it is provided with an outer shell 209b which positively
influences these properties.
[0078] FIG. 3 shows a further embodiment of an implantable
electrode lead, in the case of which an inner coil 307a, which
comprises a plurality of wound individual wires, is disposed, as
the first electrode supply lead (or the first group of supply
leads), coaxially to an outer coil 307b, which likewise comprises a
plurality of wound individual wires (and which can likewise form a
group of electrode supply leads). A silicone tube 309a is provided
between the inner coil 307a and the outer coil 307b, and the outer
coil 307b is enclosed by a further insulating tube 309b which can
likewise be comprised of, for example, silicone or a polyurethane
or a copolymer. A combination of a plurality of tubes can also be
used here.
[0079] FIGS. 4A and 4B show, schematically in a side view, a
section of an electrode lead 401 designed according to the present
description, in which a group of disk-shaped, hard, closely
interspaced elements 402 is disposed, as protection against strong
mechanical loads, on a lead body 409 which contains an electrode
supply lead 407. The elements 402 are spaced such that the
electrode lead 401 can bend in the stated section (see FIG. 4B).
The minimal bending radius is generally determined by the spaced
distance of the hard elements 402. FIGS. 5A and 5B show a similar
electrode lead 501 which differs from that shown in FIGS. 4A-4B
only by the tight alignment of protective hard elements 502 on lead
body 509, and by the shape of these elements 502. Both end faces of
the elements 502 are conical (and therefore the overall shape is
approximately disk-shaped), thereby enabling the electrode lead 501
to bend in the stated section (see FIG. 5B) despite the tight
alignment. The minimal bending radius is determined by the cone
angle of the end faces of hard elements 502.
[0080] FIGS. 6A-6C show perspective depictions of various shaped
hard elements 602.1, 602.2 and 602.3. All embodiments have the main
shape of a cylinder or a disk, and a central lumen 608a for a first
electrode supply lead, which is not depicted. Hard element 602.1,
as shown in FIG. 6A, also comprises two radial recesses 608b and
608c, in which further electrode supply leads can be placed. In the
case of hard element 602.2, shown in FIG. 6B, and 602.3, shown in
FIG. 6C, a second inner lumen 608b' is provided in place of one
radially open recess 608b. Moreover, in the case of hard element
602.3, shown in FIG. 6C, remaining recess 608c' is curved, as, for
example, a section of a coil, and so when a plurality of similarly
shaped elements are disposed in a row, a coiled extension of this
recess or groove results and can be used to determine an identical
coiled extension of an electrode supply lead placed therein.
[0081] In the case of hard elements 602.1, 602.2, 602.3 shown in
FIGS. 6A-6C, central lumen 608a can accommodate, for example, a
guide wire, a tube, a coiled electrode supply lead, or a rope-like
electrode supply lead. Supply leads that are rope-like and extend
separately or are designed as thin coils can be accommodated in the
recesses, which are accessible from the outside, or in further
lumina. The recesses, which are accessible from the outside, can be
formed subsequently in the electrode lead. This is not an option,
however, when disposed in smaller lumen 608b', but the rope-shaped
or coiled supply lead extending therein is better insulated against
the surroundings. Structures formed in this manner provide a
certain amount of protection for the supply lead if they are
intended to be guided under a ring electrode or a shock coil.
[0082] FIG. 7 shows, in a schematic side view, as another
embodiment of the present description, an electrode lead 701 in a
bent state. The electrode lead 701 likewise comprises hard elements
702 aligned in a section which is exposed to special mechanical
loads. The main shape of the hard elements 702 is cylindrical,
having the one end face of which has a triangularly notched cross
section, and the other end face of which has a projecting contour
that matches the shape of the aforementioned triangular notch.
Similar to the embodiment shown in FIGS. 5A and 5B, this shape of
the hard elements also enables the electrode lead to bend with a
predetermined minimum radius.
[0083] FIG. 8 shows, as an embodiment of the design shown in FIG.
7, three hard elements 802 which are adjacent to one another and
are detached from the actual lead body, in the case of which a
central lumen 808a as well as a laterally offset, smaller lumen
808b are provided in each hard element 802. The second lumen 808b
is situated close to a plane of symmetry of the hard elements 802,
which simultaneously determines the plane--which is orthogonal
thereto--in which the electrode lead provided with such elements
802 can bend, thereby ensuring that the rope extending there
through is neither substantially stretched nor substantially
compressed when the electrode lead bends. As a result, relative
movements between the electrode supply lead accommodated in the
lumen and the protective elements are largely prevented.
[0084] Another embodiment of the design principle depicted in
sketches in FIGS. 7 and 8 is shown in FIG. 9 in the form of a group
of hard elements 902a, 902b, 902c. In addition to a central lumen
908a, these elements each comprise two radial grooves 908b and 908c
which do not extend parallel to the central lumen 908a (and
therefore in the longitudinal direction of the particular element),
but rather obliquely thereto. According to this embodiment, a group
of hard elements is shaped--being coordinated with one
another--such that the plane of symmetry of the notch on an end
face is oriented orthogonally to the orientation of the notch on
the other end face, simultaneously ensuring a continuous, coiled
extension of radial grooves 908b, 908c over all elements in the
row. Thus, the electrode body can bend in any direction even if
only three chain elements are aligned.
[0085] FIG. 10 shows, schematically, as another embodiment of the
present description, a group of three hard elements 1002 which are
to be applied onto or in an electrode lead body. The hard elements
1002 are characterized by a spherical or circular disk-shaped
projection 1002.1 on the one end face, which is otherwise, for
example, conical in shape, and a matching ball socket 1002.2 on the
other end face which has a shallower slope and is likewise conical
in shape. In the installed state, the balls or circular disks
1002.1 and ball sockets and circular disk sockets 1002.2 form a
rotationally symmetrical joint connection between the hard elements
1002, thereby enabling an electrode lead equipped therewith to bend
in any direction.
[0086] As an alternative to the joint connection sketched in FIG.
10, FIG. 11 shows another solution for ensuring high bendability in
the form of an electrode lead 1101. Lead 1101 comprises a lead body
1109 which typically is comprised of an elastic plastic material,
and the internal components (special supply leads) of which are not
depicted here. First hard elements 1102a and second hard elements
1102b are slid onto lead body 1109 in alternation. The depiction in
FIG. 11 is purely schematic, although it illustrates how first hard
elements 1102a have a cylindrical to barrel-type main shape and
both of their end faces have a concave shape, while second hard
elements 1102b have an approximately spherical main shape and
engage the first hard elements 1102a in the concave end faces. This
engagement also results in the formation of a type of ball joint,
thereby enabling the electrode lead 1101 to bend in all planes.
[0087] FIG. 12 shows, in a schematic longitudinal cross-sectional
view, another electrode lead 1201 according to the present
description, which comprises an electrode supply lead 1207, a group
of first hard elements 1202a which protect the supply lead 1207,
and a lead body 1209 which is situated on the outside in this case
and encloses supply lead 1207 with hard elements 1202a placed
thereon. A unique feature of the embodiment shown in FIG. 12 is
that an individual hard element 1202b of a second type is inserted
between disk-shaped, hard elements 1202a. This different element
1202b is generally drum-shaped and contains in the interior thereof
a coil 1206 which is an additional electrical component and is
connected mechanically and electrically to central electrode supply
lead 1207. This connection can be configured as an electrical
series circuit, thereby increasing the inductance of the electrode
supply lead 1207. The drum-shaped housing of hard element 1202b is
rotatably supported on the electrode supply lead 1207, thereby
enabling the lead body 1209 to rotate relative to the electrode
supply lead 1207 with the coil 1206 securely placed thereon and
preventing torsional stresses from forming during use of the
electrode lead 1201.
[0088] FIG. 13 shows, as another embodiment of the present
description, an electrode lead 1301 which is protected by hard
elements 1302a, the design of which is similar to the embodiment
depicted in FIG. 6A. Electrode lead 1301 comprises a ring electrode
1310 which is situated as a ring around the outer circumference of
a different hard element 1302b. In the case of element 1302b,
second radial recess 1308c is reduced in size such that a supply
lead 1307c accommodated therein is forced into mechanical and
electrical contact with the inner wall of ring electrode 1310,
which is thereby connected electrically to supply lead 1307c. The
connection can also be fixed using a welding point or other known
means.
[0089] FIGS. 14A and 14B show two fundamentally different
embodiments of "hard elements" for protecting an electrode lead. In
both embodiments, a tube 1400 or 1400' is machined (e.g., using a
laser cutting procedure or other known means) in a manner such that
non-machined and therefore rigid ("hard") sections 1402 and 1402'
alternate with ("soft") machined sections 1404 and 1404', which are
deformed relatively easily due to the recesses created by the
machining. In the embodiment depicted in FIG. 14A, soft sections
1404 are created using a strip-type incision that extends in a
spiral. In the embodiment depicted in FIG. 14B, soft sections 1404'
are created using circular incisions applied such that they
alternate by approximately 90.degree., thereby ensuring that the
electrode lead protected by the protective tube 1400, 1400' can
bend in at least two planes.
[0090] To illustrate another embodiment of the present description,
FIG. 15A shows a lead body 1509 having a central lumen 1508 for
receiving electrode supply leads (not depicted), which is formed by
enclosing relatively greatly interspaced hard elements 1502 in a
coating of an elastic mass applied by injection molding. By
applying the coating via injection molding at a relatively great
distance, "soft", i.e., flexurally resilient and flexibly yielding,
lead body sections 1504 are formed between each of the hard
elements 1502 and ensure that the final electrode lead is
sufficiently flexible. FIG. 15B shows, as an alternative design
having a comparable function, a lead body 1509' which is formed by
pressing rounded, disk-shaped (lenticular), hard elements 1502'
onto a tube 1509a comprised of a flexurally resilient and
compressible material disposed at a predetermined distance from one
another. In this case as well, distance ranges 1504 between hard
elements 1502' are deformed relatively easily and therefore
represent a type of hinged connection between the "hard"
sections.
[0091] FIG. 16 shows, in a sketch of another embodiment of the
present description, a distal section of an electrode lead 1601. In
the electrode lead 1601, first hard elements 1602a, which are used
exclusively for protection against mechanical stress, are provided,
as well as an element 1602b comprising a securing hook 1611 which
can be extended after implantation. The securing hook 1611 (shown
extended in FIG. 16) is controlled using a guide wire (not shown)
for securing the electrode lead 1601 in the patient's bodily
tissue. Element 1602b, comprising the securing hook 1611, is
situated close to a distal electrode 1603 of lead 1609.
[0092] The embodiment of the present description is not limited to
the above-described examples and emphasized aspects, but rather is
possible in a large number of modifications that lie within the
scope of a person skilled in the art. Those of skill in the art
will readily appreciate that embodiments in accordance with the
present invention may be implemented in a very wide variety of
ways. This application is intended to cover any and all adaptations
and/or variations of the embodiments discussed herein.
[0093] The terms and expressions which have been employed in the
foregoing specification are used therein as terms of description
and not of limitation, and there is no intention, in the use of
such terms and expressions, to exclude equivalents of the features
shown and/or described or portions thereof, it being recognized
that the scope of the invention is defined and limited only by the
claims that follow.
[0094] 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.
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