U.S. patent application number 14/855253 was filed with the patent office on 2016-04-21 for implantable electrical line.
This patent application is currently assigned to Biotronik SE & Co. KG. The applicant listed for this patent is Biotronik SE & Co. KG. Invention is credited to Michael FRIEDRICH, Jens RUMP, Pierre WEITZIG.
Application Number | 20160106973 14/855253 |
Document ID | / |
Family ID | 54106251 |
Filed Date | 2016-04-21 |
United States Patent
Application |
20160106973 |
Kind Code |
A1 |
WEITZIG; Pierre ; et
al. |
April 21, 2016 |
IMPLANTABLE ELECTRICAL LINE
Abstract
Embodiments include an implantable electrical line with at least
one helically wound electrical conductor, an electrically
conductive sleeve electrically connected to the electrical
conductor, and an electrical filter. The electrical filter is
arranged between a proximal and a distal longitudinal portion of a
helix formed by the at least one helically wound electrical
conductor as viewed in a longitudinal direction of the implantable
electrical line, and is also arranged within the electrically
conductive sleeve as viewed in a radial direction of the
implantable electrical line.
Inventors: |
WEITZIG; Pierre; (Irrel,
DE) ; FRIEDRICH; Michael; (Kleinmachnow, DE) ;
RUMP; Jens; (Berlin, DE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Biotronik SE & Co. KG |
Berlin |
|
DE |
|
|
Assignee: |
Biotronik SE & Co. KG
Berlin
DE
|
Family ID: |
54106251 |
Appl. No.: |
14/855253 |
Filed: |
September 15, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62064486 |
Oct 16, 2014 |
|
|
|
Current U.S.
Class: |
607/122 ;
29/855 |
Current CPC
Class: |
A61N 1/056 20130101;
A61N 1/086 20170801 |
International
Class: |
A61N 1/05 20060101
A61N001/05; A61N 1/08 20060101 A61N001/08 |
Claims
1. An implantable electrical line comprising: at least one
helically wound electrical conductor; at least one electrically
conductive sleeve electrically connected to the at least one
helically wound electrical conductor; and, at least one electrical
filter; wherein the at least one electrical filter is arranged
between a proximal longitudinal portion and a distal longitudinal
portion of a helix formed by the at least one helically wound
electrical conductor in a longitudinal direction of the implantable
electrical line, and wherein the at least one electrical filter is
further arranged within the at least one electrically conductive
sleeve in a radial direction of the implantable electrical
line.
2. The implantable electrical line as claimed in claim 1, wherein
the implantable electrical line is a multi-pole electrode line,
wherein the at least one electrically conductive sleeve comprises a
plurality of electrically conductive sleeves as electrode poles,
wherein the at least one helically wound electrical conductor
comprises a plurality of helically wound electrical conductors,
wherein each of the plurality of electrically conductive sleeves
are electrically connected to an electrical conductor of the
plurality of helically wound electrical conductors, and wherein the
plurality of helically wound electrical conductors form a co-radial
line coil.
3. The implantable electrical line as claimed in claim 1, further
comprising a proximal electrode pole located at a most proximal
portion of the implantable electrical line, wherein the at least
one electrical filter comprises an electrical filter associated
with the proximal electrode pole and associated with an
electrically conductive sleeve of the at least one electrically
conductive sleeve, and wherein the electrical filter is arranged
proximally to the associated electrically conductive sleeve.
4. The implantable electrical line as claimed in claim 1, further
comprising a distal electrode pole located at a most distal portion
of the implantable electrical line, wherein the at least one
electrical filter comprises an electrical filter associated with
the distal electrode pole, and wherein the electrical filter
associated with the distal electrode pole is arranged distally to
the distal electrode pole.
5. The implantable electrical line as claimed in claim 1, wherein
the at least one electrical conductive sleeve forms an electrode
pole, wherein the at least one electrical filter is associated with
the electrode pole, and wherein the at least one electrical filter
is arranged within the at least one electrically conductive sleeve
that forms the electrode pole.
6. The implantable electrical line as claimed in claim 1, wherein
each of the at least one electrically conductive sleeve forms a
ring electrode or an electrode line.
7. The implantable electrical line as claimed in claim 1, wherein
the at least one electrical filter comprises a coil made of
insulated wire, wherein said coil is wound with an odd number of
layers around a hollow cylindrical core in a helical manner.
8. The implantable electrical line as claimed in claim 1, wherein
the at least one electrical filter comprises a coil made of
insulated wire, wherein said coil is wound with an even number of
layers around a hollow cylindrical core in a helical manner.
9. The implantable electrical line as claimed in claim 1, wherein
the at least one electrical filter comprises a non-insulated or
insulated wire wound in a single layer and a capacitive
element.
10. The implantable electrical line as claimed in claim 1, wherein
the at least one electrical filter comprises a coil, wherein the
coil is wound in a spiraled manner around a hollow cylindrical core
and wherein the coil comprises a film metalized on one side of the
coil.
11. The implantable electrical line as claimed in claim 10, wherein
the film is a plastic film.
12. The implantable electrical line as claimed in claim 1, wherein
the at least one electrical filter comprises a band-stop filter or
a low-pass filter.
13. The implantable electrical line as claimed in claim 1, wherein
the at least one helically wound electrical conductor comprises a
plurality of helically wound electrical conductors that form a
co-radial coil feed line, wherein the plurality of helically wound
electrical conductors comprise a cut conductor with cut line ends
and at least one other conductor that is not cut, wherein the at
least one electrical filter is electrically connected to the cut
line ends of the conductor of the co-radial coil feed line, and
wherein the at least one other conductor of the co-radial coil feed
line that is not cut is passed by the at least one electrical
filter in an interrupted manner.
14. A method of producing an electrode line with at least one
electrode pole and at least one electrical filter, wherein the
method comprises: untwisting a co-radial coil feed line at a
location of the at least one electrode pole, cutting a conductor of
the co-radial coil feed line, such that cut line ends are produced,
freeing the cut line ends from insulation, inserting at least one
electrical filter where the co-radial coil feed line is untwisted,
electrically contacting the at least one electrical filter with the
cut line ends of the cut conductor freed from insulation, sliding
on at least one electrically conductive sleeve forming a subsequent
electrode pole, such that the at least one electrical filter is
located within the at least one electrically conductive sleeve,
contacting the at least one electrically conductive sleeve, and,
insulating exposed wires and contact points in the region of the at
least one electrode pole.
Description
[0001] This application claims the benefit of U.S. Provisional
Patent Application 62/064,486 filed on 16 Oct. 2014, the
specification of which is hereby incorporated herein by
reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] Embodiments of the invention generally relate to a
permanently or temporarily implantable medical device that includes
an elongate electrical conductor, specifically an implantable
electrical line with an electrical filter to avoid radio
frequency-induced heating.
[0004] 2. Description of the Related Art
[0005] Such devices, for example electrode lines for
electrostimulation, generally have the disadvantage that their
electrical conductor may heat up in a magnetic resonance imaging
(MRI) scanner because the alternating magnetic fields prevailing in
the MRI scanner induce electrical currents in the electrical
conductor that are significant. Therefore, typically, cardiac
pacemaker patients nowadays cannot generally be examined in an MRI
scanner or may only be examined in this way to a limited
extent.
[0006] Specifically, at least one stimulation electrode line is
typically connected to implantable cardiac pacemakers or
defibrillators. Generally, at its proximal end intended for
connection to the cardiac pacemaker or defibrillator, the at least
one stimulation electrode line includes a standardized electrical
terminal, and, at its distal end intended for placement in the
heart, includes one or more electrode poles. Such an electrode pole
is typically used to deliver electrical pulses to the tissue
(myocardium) of the heart or to sense electrical fields in order to
sense cardiac activity, also referred to as sensing. For this
purpose, electrode poles typically form electrically conductive
surface portions of an electrode line. Electrode poles are
typically provided as ring electrodes in the form of a ring around
the electrode line or in the form of a point electrode or tip
electrode at the distal end of the electrode line. The electrode
poles are generally electrically conductively connected via one or
more electrical conductors to contacts of the electrical terminal
of the electrode line at the proximal end thereof. One or more
electrical conductors, which electrically connect one or more of
the electrode poles to one or more of the contacts, thus typically
run between the contacts of the electrical terminal of the
electrode lines at the proximal ends thereof and the electrode
poles at the distal end of the electrode line. These electrical
conductors, generally, may be used on the one hand for transmission
of stimulation pulses to the electrode poles and on the other hand
for transmission of electrical signals, received by means of the
electrode poles, to the proximal end of the electrode line, also be
referred to herein as a function line. Such function lines are
typically electrical conductors necessary for the functions of the
respective electrode line and as such are exposed to the risk that
electrical currents are induced therein as a result of external
alternating magnetic fields. The electrical currents for example
may typically lead to an undesirable heating of the function lines
or of the electrode poles connected thereto, or may lead to the
delivery of corresponding currents via the electrode poles to
surrounding tissue and therefore to a heating of the surrounding
tissue.
[0007] Implantable lines, generally, as are used inter alia as
electrode lines for cardiac pacemakers, act similarly to an antenna
when exposed to irradiation of electromagnetic waves and may
convert the absorbed energy into heat. Typically, the heating
occurs preferably at line ends, which may lead to tissue damage. By
means of a band-stop filter (or other electrical filter) connected
electrically in series to the electrode pole and mechanically
located either proximally or distally in relation thereto,
electrical waves in the radiofrequency range are generally
reflected and the heating of the tissue at the electrode pole is
thus typically reduced.
[0008] Generally, for electrode lines with coaxial coils, in which
the functional conductors each form an individual helix each having
a different diameter, it is known to provide a capacitively coupled
shunt or in each case a band-stop filter proximally in relation to
the electrode.
[0009] For multi-pole electrode lines which have a number of
electrode poles which are each connected to a dedicated functional
conductor with corresponding contacts of the electrical terminal of
the electrode line, a line construction is typically additionally
used and is also referred to as a co-radial line. Generally, the
individual functional conductors are insulated from one another and
are wound to form a multi-turn helix, in which the individual
conductors form helices congruent with one another with identical
diameter and identical pitch. Typically, the helices engage with
one another such that the turns of the individual helices follow
one another periodically in the longitudinal direction of the
helix, similarly to thread turns of a multi-turn screw, and thus
form a co-radial line coil. In particular for co-radial electrode
lines, such as electrode lines with a co-radial line coil, there is
no known previous satisfactory solution for producing band-stop
filters.
BRIEF SUMMARY OF THE INVENTION
[0010] One or more embodiments of the invention include an improved
implantable line with an electrical filter.
[0011] At least one embodiment of the invention includes an
implantable electrical line having at least one helically wound
electrical conductor, an electrically conductive sleeve
electrically connected to the electrical conductor, and an
electrical filter. In one or more embodiments, the electrical
filter may be arranged between a proximal and a distal longitudinal
portion of a helix formed by the at least one helically wound
electrical conductor, as viewed, in a longitudinal direction of the
electrical line. In at least one embodiment, the electrical filter
may be arranged within the electrically conductive sleeve, as
viewed, in a radial direction of the electrical line.
[0012] By way of one or more embodiments, the implantable
electrical line may be a multi-pole electrode line with a plurality
of electrically conductive sleeves as electrode poles. In at least
one embodiment, each of the plurality of electrically conductive
sleeves may be electrically connected to an electrical conductor,
and wherein the electrical conductors may form a co-radial line
coil.
[0013] At least one embodiment of the invention is based on the
finding that one of the most effective measures against MRI heating
is a band-stop filter, for example an element electrically
connected between the feed line and the associated electrode pole.
However, with a co-radial electrode line, there may be a lack of
space, for example radially, to accommodate such a filter. For
example, with a co-radial electrode line, there may be a lack of
space mechanically, such as immediately proximal to the respective
electrode pole, to accommodate such a filter. In addition, a filter
may be required for each of the electrode poles, for example for
one or more of four electrode poles. At least one embodiment of the
invention may include the respective electrical filters, such as
band-stop filters, provided in an axially shifted position at
points that provide more space without impairing the flexibility or
other functional properties of the electrode. One or more
embodiments may include an electrical filter as the respective
filter, for example a low-pass filter.
[0014] At least one embodiment of the invention includes a
multi-pole electrode line which includes at least one electrode
pole arranged furthest distally, or most distal, on the electrode
line, a different electrode pole arranged furthest proximally, or
most proximal, on the electrode line, and at least one middle
electrode pole arranged therebetween. One or more embodiments may
include a respective electrical filter, for the at least one middle
electrode pole and/or the at least one most distal electrode pole,
that is arranged within the electrically conductive sleeve forming
the respective adjacent, next-proximal electrode pole. In at least
one embodiment, a respective electrical filter for a respective
electrode pole, such as at least the middle electrode pole, may not
be arranged within the associated electrically conductive sleeve,
but within a nearest adjacent electrically conductive sleeve. As
such, in one or more embodiments, contact of a filter for an
electrode pole and the associated electrically conductive sleeve is
facilitated.
[0015] In at least one embodiment of the invention, the electrical
filter of the most proximal electrode pole may be arranged
proximally to the associated electrically conductive sleeve, such
as in an area of the electrode line that may be more rigid and/or
may have a greater diameter than the distal region, without
impairing the other functions of the electrode line.
[0016] In one or more embodiments, the electrical filter for the
most distal electrode pole may be arranged distally in relation to
the distal electrode pole, for example in a flexible tip region of
the electrode line.
[0017] In at least one embodiment, a respective electrically
conductive sleeve may form a ring electrode of the electrode
line.
[0018] At least one embodiment of the invention includes a
multi-pole electrode line with a co-radial feed line structure that
may include the following arrangement of the electrical filters:
[0019] the filter may be located beneath the associated ring
electrode, [0020] or [0021] the filters for the middle electrode
poles and/or most distal ring electrodes may be located beneath the
adjacent, in each case next-proximal, ring electrode, [0022] the
filter for the most proximal ring electrode may be located
proximally in relation thereto, in a region of the electrode that
may be more rigid and/or may be of greater diameter than the distal
region, without impairing the other functions of the electrode, and
[0023] the filter for the most distal electrode pole may be located
distally in relation to the most distal electrode pole, in a
flexible tip region of the electrode line.
[0024] In at least one embodiment, the respective electrical filter
may include one or more of the following variants: [0025] the
filter may include a coil made of insulated wire, which is wound
with an odd number of layers around a hollow cylindrical core in a
helical manner, [0026] the filter may include a coil made of
insulated wire, which is wound with an even number of layers around
a hollow cylindrical core in a helical manner, [0027] the filter
may include a bare or insulated wire wound in a single layer, and
optionally an additional capacitive element, [0028] the filter may
include a coil, which is wound in a spiraled manner around a hollow
cylindrical core and which is made of a film metalized on one side,
and wherein the film may include a plastic film, and [0029] the
electrical filter may include or may be a band-stop filter or a
low-pass filter.
[0030] By way of at least one embodiment, a respective electrical
filter may be electrically connected to cut line ends of a cut
conductor of a co-radial coil feed line, and wherein other
conductors of the co-radial coil feed line may not be cut in the
region of the electrical filter, but are passed by the electrical
filter without interruption.
[0031] One or more embodiments may include a method of producing an
electrode line with at least one electrode pole and an electrical
filter, wherein the method may include one or more of the following
steps: [0032] untwisting the co-radial coil feed line at the
location of the electrode pole, [0033] cutting a conductor of the
co-radial coil feed line, such that cut line ends are produced,
[0034] freeing the cut line ends from insulation, [0035] inserting
an electrical filter where the co-radial coil feed line is
unraveled, [0036] electrically contacting the electrical filter
with the ends of the cut conductor freed from insulation, [0037]
sliding on an electrically conductive sleeve forming a subsequent
electrode pole, such that the electrical filter is ultimately
located within the electrically conductive sleeve, [0038]
contacting the electrically conductive sleeve, and [0039]
insulating exposed wires and contact points in the region of the
electrode pole.
[0040] In at least one embodiment of the invention, advantages may
be attained with an electrode line as discussed herein.
[0041] For example, in one or more embodiments, an advantage may
include wherein space is created to accommodate and include a
band-stop filter whilst maintaining the favorable flexibility in
other portions of the electrode body.
[0042] For example, in at least one embodiment, an advantage may
include placement of a distal electrical filter in the distal end
of the electrode line, wherein a flexible distal end without
electrode poles may be required to avoid phrenic nerve stimulation,
which may occur otherwise if the ring electrodes are positioned too
far distally.
BRIEF DESCRIPTION OF THE DRAWINGS
[0043] The above and other aspects, features and advantages of at
least one embodiment of the invention will be more apparent from
the following more particular description thereof, presented in
conjunction with the following drawings, wherein:
[0044] FIG. 1 shows, as implantable medical devices, an implantable
heart stimulator and an implantable electrode line connected
thereto.
[0045] FIG. 2 shows details of a co-radial coil feed line prior to
installation of a filter.
[0046] FIG. 3 shows details of a co-radial coil feed line following
installation of the filter.
[0047] FIG. 4 shows a distal end of a co-radial coil feed line.
[0048] FIG. 5 shows a distal end of a co-radial coil feed line.
[0049] FIG. 6 shows a detail of a co-radial coil feed line.
[0050] FIG. 7 shows a distal end of a two-pole electrode line.
[0051] FIG. 8 shows details of a co-radial coil feed line prior to
installation of the filter.
[0052] FIG. 9 shows details of a co-radial coil feed line following
installation of the filter.
[0053] FIG. 10 shows a co-radial coil feed line with a fitted
insulating sleeve.
[0054] FIG. 11 shows details of a co-radial coil feed line prior to
installation of the filter.
[0055] FIG. 12 shows details of a co-radial coil feed line
following installation of the filter.
[0056] FIG. 13 shows a co-radial coil feed line with a slid-on
electrically conductive sleeve.
[0057] FIG. 14 shows a detail of a finished co-radial coil feed
line.
DETAILED DESCRIPTION OF THE INVENTION
[0058] The following description is of the best mode presently
contemplated for carrying out at least one embodiment of the
invention. This description is not to be taken in a limiting sense,
but is made merely for the purpose of describing the general
principles of the invention. The scope of the invention should be
determined with reference to the claims.
[0059] FIG. 1 shows, as implantable medical devices, an implantable
heart stimulator 10 and an implantable electrode line 20 connected
thereto, according to one or more embodiments of the invention.
FIG. 2 shows details of a co-radial coil feed line prior to
installation of a filter, according to one or more embodiments of
the invention. As shown in FIG. 1, in at least one embodiment, the
implantable heart stimulator 10 may be a cardiac pacemaker or a
cardioverter/defibrillator (ICD). In at least one embodiment, the
heart stimulator 10 may be a ventricular cardiac pacemaker and
defibrillator. In one or more embodiments, the heart stimulator 10
may include dual-chamber cardiac pacemakers to stimulate the right
atrium and the right ventricle, or biventricular cardiac
pacemakers, which may also stimulate the left ventricle in addition
to the right ventricle.
[0060] By way of at least one embodiment, the heart stimulator 10
may include a housing 12, which may include metal, which may be
electrically conductive and which may serve as a large-area
electrode pole. In one or more embodiments, a terminal housing 14
may be fastened to the outer face of the housing 12, also referred
to herein as a header. In at least one embodiment, such a header
may include contact sockets that receive plug contacts. In one or
more embodiments, the contact sockets may include electrical
contacts 16, which may be connected via corresponding conductors to
an electronics unit arranged in the housing 12 of the heart
stimulator 10.
[0061] By way of one or more embodiments, the electrode line 20 may
constitute an implantable medical device in general and an
implantable electrical line in particular. In at least one
embodiment, electrode poles in the form of a point or tip electrode
22 and a ring electrode 24 arranged in the vicinity thereof may be
arranged at the distal end of the electrode line 20. In one or more
embodiments, the electrode poles 22 and 24 may be used, depending
on the function of a heart stimulator to which the electrode line
20 is connected, to sense electrical potentials of the heart
tissue, or myocardium, or to deliver electrical signals, for
example to deliver stimulation pulses to the surrounding heart
tissue. FIG. 1 shows how the electrode poles, such as the tip
electrode 22 and the ring electrode 24, in the event of use of the
electrode line 20, may be located in the apex of the right
ventricle of a heart, according to one or more embodiments of the
invention. In at least one embodiment of the invention, the
electrode line 20 may include an electrically insulating sleeve
50.
[0062] In at least one embodiment, both the tip electrode 22 and
the ring electrode 24 may be electrically connected in each case
via at least one electrical conductor 26.1 and 26.2, and/or 26.3,
to a plug contact 28 at the proximal end of the electrode line 20.
In one or more embodiments, the electrical conductors together may
form a co-radial coil feed line 26. In at least one embodiment, the
plug contact 28 may include electrical contacts that correspond to
the electrical contacts 16 of the contact socket in the terminal
housing 14 of the implantable heart stimulator 10. In one or more
embodiments, the electrical conductors 26 in the electrode line 20
may be formed as approximately elongate cable conductors or as
helically coiled conductors. In at least one embodiment, such
conductors, which electrically conductively connect the functional
electrode poles to electrical contacts of the plug contact at the
proximal end of the electrode line 20, will also be referred to
herein as function conductors. In one or more embodiments, for
example, the function conductors may transmit electrical signals,
used to provide therapy, from the plug contact to the respective
electrode pole, or may guide sensed signals representing electrical
potentials from the respective electrode pole to the plug contact,
and as such may be used during the basic function of the medical
device.
[0063] By way of at least one embodiment, the electrical conductors
26, which connect the electrode poles 22 and 24 to the electrical
contacts of the plug 28 of the electrode line 20, may be surrounded
over the majority of their length by an insulating sleeve, such
that electrical contact with the tissue of the heart is produced
selectively via the electrode poles 22 and 24.
[0064] In one or more embodiments, besides the electrode poles 22
and 24, which may be used to stimulate the heart tissue, such as by
ventricular stimulation, the electrode line 20 may include two
electrode poles 30 and 32. In at least one embodiment, the two
electrode poles 30 and 32 may have a greater area than the
electrode poles 22 and 24, may be used as defibrillation
electrodes, and may be formed by at least one bare helically wound
wire.
[0065] It should be noted wherein one or more embodiments are
explained within the scope of this invention on the basis of a
right-ventricular cardiac pacemaker and defibrillator. However, at
least one embodiment of the invention may include an ablation
electrode line, for example, as the medical device, wherein the
ablation electrode line, in the event of use, may protrude into the
heart of a patient, and may be controlled by a device arranged
outside of the patient and be connected thereto.
[0066] FIG. 1 shows an electrode line 20 with two electrode poles
22 and 24, of which the electrode pole 24 is a ring electrode,
according to one or more embodiments of the invention. At least one
embodiment of the invention may include electrode lines that have a
plurality of electrode poles in the form of ring electrodes.
[0067] In order to avoid the problems as described in the
Description of the Related Art above, for example in order to avoid
a heating of the electrode poles, one or more embodiments of the
invention include an electrical filter 40 that may be associated
with each electrode pole, and may include or may be a band-stop
filter or a low-pass filter. FIGS. 2 to 14, in at least one
embodiment, show how, for example with co-radial electrode lines,
the electrical filters 40 may be arranged and electrically
connected to a respective electrode pole.
[0068] As discussed above, in at least one embodiment, the
respective electrical filter may include one or more of the
variants. In one or more embodiments, an electrical filter may
include a metallic wire or a metallic film, which is wound such
that a resultant inductance and a capacitance, such as a parasitic
capacitance, form a band-stop filter or a low-pass filter. In at
least one embodiment, the resonance frequency or stop frequency of
the band-stop filter or the low-pass filter may be close to the
frequency of an anticipated interfering electromagnetic field, such
as at the frequency of the electrical fields generated by a
magnetic resonance imaging (MRI) device. In one or more
embodiments, the electrical filter 40 may include a coil made of a
film metalized on one side, which is wound around a hollow
cylindrical core in a spiraled manner, wherein an additional
capacitive element may be included and may be electrically
connected in parallel to the inductor, if the parasitic capacitance
through the capacitor formed by the metalized film is insufficient
to attain a desired resonance frequency.
[0069] One or more embodiments of the electrical filter may include
a central lumen, though which a stylet or guide wire may be slid.
In at least one embodiment, a respective electrical filter may be
installed in an electrode body of the electrode line such that the
electrical filter is protected against additional load, for example
against cyclical bending.
[0070] In order to install an electrical filter 40 in an electrode
line, for example a co-radial electrode line, such that the
diameter and rigidity thereof do not suffer and the electrical
filter is simultaneously protected, one or more embodiments of the
invention may include a respective electrical filter 40 arranged
beneath an electrically conductive sleeve, for example to form a
ring electrode pole 24. As such, in at least one embodiment, as
illustrated in FIG. 2, a co-radial coil feed line 26 may be
untwisted at a location at which an electrical filter 40 may be
mounted, such that initially the helix shape of the co-radial coil
feed line is interrupted at the location, without severing the
electrical conductors themselves.
[0071] As shown in FIG. 2, at least one embodiment may include a
co-radial coil feed line, in which two double lines, a light line
and a dark line, are connected to form a co-radial coil. In one or
more embodiments, with the co-radial coil feed line, the two dark
conductors 26a may contact a first electrode pole, and the two
light conductors 26b may contact a second electrode pole. In at
least one embodiment of the invention, one of the two electrode
poles 24 may be located in the finished state of the electrode line
at the location illustrated in FIG. 2, at which the helix shape of
the co-radial coil feed line is interrupted. It is noted wherein
FIG. 2 does not show an image of the finished electrode line
20.
[0072] FIG. 3 shows details of a co-radial coil feed line following
installation of the filter, according to one or more embodiments of
the invention. FIG. 3 shows how, in at least one embodiment, after
untwisting the co-radial coil feed line, an electrical filter 40
may be arranged in the untwisted portion of the co-radial coil feed
line. By way of one or more embodiments, in order to contact the
electrical filter 40, one of the conductors 26, shown as a dark
conductor in FIG. 3, may be interrupted and a stripped end of the
conductor may be connected to a proximal connection sleeve 42 of
the electrical filter 40, for example by welding. At least one
embodiment of the invention may include a further wire 44, wherein
a second connection sleeve 46 at the other end of the electrical
filter 40 may be connected to an electrically conductive sleeve
forming an electrode pole. In one or more embodiments, the
electrically conductive sleeve may be slid over the electrical
filter 40 illustrated in FIG. 3, and may be electrically connected
to the wire 44. In at least one embodiment, the electrical filter
40 may be located within the electrically conductive sleeve forming
the electrode pole with which the electrical filter 40 is
associated.
[0073] To insert the electrical filter 40, by way of at least one
embodiment, an auxiliary element 48, for example a plastic tube
that may be made of polyimide, may be introduced into the central
lumen of the co-radial coil feed line and of the electrical filter
40, to hold the electrical filter 40 in place and to stabilize the
electrical filter until the electrode line 20 is finished. In at
least one embodiment, the plastic tube 48 may then remain in place
or may be removed.
[0074] For example, the connection of an electrically conductive
sleeve to an accordingly short wire, such as the wire 44, within
the electrically conductive sleeve may be difficult. As such, at
least one embodiment may include a respective electrically
conductive filter 40 provided within an adjacent electrically
conductive sleeve, for example not beneath the electrically
conductive sleeve forming the electrode pole with which the
electrical filter 40 is associated. In one or more embodiments, the
respective electrical filter 40 may be electrically connected to
the conductor 26 leading to an adjacent electrically conductive
sleeve and not the electrically conductive sleeve within which the
electrical filter 40 is arranged. The method of producing an
electrode line, as discussed herein, will be described in greater
detail below regarding FIGS. 7 to 14.
[0075] As discussed above, at least one embodiment of the invention
may include a respective electrical filter 40 for a proximal
electrode pole that may be arranged proximally to the electrode
pole, wherein alternative stiffening support elements that
stabilize the filter may also be arranged in the region of an
electrode line.
[0076] By way of one or more embodiments, with a most distal ring
electrode pole 24, the associated electrical filter 40 may be
attached not within the electrically conductive sleeve forming the
most distal ring electrode pole, but at a further distally arranged
location of the electrode line 20. In at least one embodiment, a
corresponding conductor 26 which, in the case of an electrode line,
may directly contact the electrical sleeve of the distal ring
electrode pole, may be continued a few millimeters, and may be
contacted with a connection sleeve 42, such as a proximal
connection sleeve, of the corresponding electrical filter 40. In
one or more embodiments, the corresponding distal connection sleeve
46 of the electrical filter 40 may be connected to the electrically
conductive sleeve via a wire 44' returned to the electrical sleeve,
for example via a loosely coiled cable; as shown in FIG. 4.
[0077] FIG. 4 shows a distal end of a co-radial coil feed line,
according to one or more embodiments of the invention. As shown in
FIG. 4, in at least one embodiment, the electrical filter 40 may
include a wire 52, which is wound in a single layer, and a coil
such that an inductance of the electrical filter 40 is formed. When
the wire forming the coil and therefore the inductance of the
electrical filter is not wound in a single layer or with an odd
number of layers, but with an even number of layers, in one or more
embodiments of the invention, both connection sleeves of the
electrical filter may be provided for example at the proximal end
thereof. As such, the wire 44' may only be returned over a shorter
distance; as shown in FIG. 5.
[0078] In at least one embodiment of the invention, with a two-pole
electrode line, in which the two electrode poles are each formed by
ring electrodes, an electrical filter for the then distal electrode
pole may be arranged as shown in FIG. 4 or 5. As shown in FIG. 4,
the electrode line may include a proximal ring electrode pole 24p
and a distal ring electrode pole 24d. In one or more embodiments,
the electrical filter for the proximal electrode pole may be
arranged proximally thereof, as discussed above. In at least one
embodiment, no electrical filter may be arranged within an
electrically conductive sleeve.
[0079] In one or more embodiments, individual conductors may be
unscrewed from the co-radial coil feed line where necessary and
stripped of their insulation. In at least one embodiment, winding
gaps may be produced in the remaining co-radial coil feed line. In
order to guide non-insulated conductors further axially along the
co-radial coil feed line, in one or more embodiments, the initially
remaining co-radial coil feed line with the winding gaps thereof
may be coated with an insulating layer, for example a silicone
tube, and the non-insulated conductors may then be wound into the
winding gaps, as illustrated in FIG. 6. FIG. 6 shows a detail of a
co-radial coil feed line, according to one or more embodiments of
the invention.
[0080] At least one embodiment of the invention may include an
additional protective tube, for example made of polyimide, which
may be fitted inside the co-radial coil feed line. One or more
embodiments may include a mechanically loadable and yet flexible
co-radial coil feed line, which may be adapted in a versatile
manner. For example, in at least one embodiment, the co-radial coil
feed line may be used to contact a distally arranged electrical
filter, as illustrated in FIGS. 4 and 5.
[0081] FIGS. 7 to 14 illustrate how an electrode line in accordance
with at least one embodiment of the invention may be produced. In
one or more embodiments, a respective electrical filter may be
arranged within an electrically conductive sleeve, which is
adjacent to the electrically conductive sleeve forming the
electrode pole with which the electrical filter is associated, and
in which the electrical filter for the most proximal electrode pole
may be arranged proximally thereof.
[0082] FIG. 7 shows a distal end of a two-pole electrode line
according to one or more embodiments of the invention, and shows a
portion of the finished electrode line 20 from the outside. As
shown in FIG. 7, in at least one embodiment, the electrode line may
include a proximal ring electrode pole 24p and a distal ring
electrode pole 24d. In one or more embodiments, both the proximal
ring electrode 24p and the distal ring electrode 24d may be formed
by or may include a respective electrically conductive sleeve, for
example a metal sleeve. In at least one embodiment, the electrode
line 20 between the electrode poles and either side of the
electrode poles may carry an electrically insulating sleeve 50,
which may be formed by or may include a silicone tube. One or more
embodiments of the invention may include a co-radial coil feed line
26, which may include or may be formed by four electrical
conductors 26.1, 26.2, 26.3 and 26.4, also shown in FIG. 8, that
extend within the sleeve 50 and within the electrically insulating
sleeves of 24p and 24d. In at least one embodiment, the associated
electrical filter 40p may be arranged proximally to the proximal
electrode pole 24p. In one or more embodiments, the electrical
filter 40d for the distal electrode pole 24d may be arranged within
the electrically conductive sleeve of the proximal electrode pole
24p.
[0083] By way of one or more embodiments, shown in FIGS. 8 to 13,
one of the four conductors 26.1, 26.2, 26.3 and 26.4 of the
co-radial coil feed line 26 is illustrated as dark, whereas the
other three conductors are illustrated as light.
[0084] FIG. 8 shows details of a co-radial coil feed line prior to
installation of the filter and FIG. 9 shows details of a co-radial
coil feed line following installation of the filter, according to
one or more embodiments of the invention. FIGS. 8 and 9, in at
least one embodiment, depict the installation of the proximal
filter 40p. In one or more embodiments, the co-radial coil feed
line 26 may first be untwisted where the proximal electrical filter
40p is to be arranged, and the electrical conductor 26.1 associated
with the proximal electrode pole 24p may be cut. In at least one
embodiment, the other electrical conductors 26.2, 26.3 and 26.4 may
not be cut and may remain insulated. In one or more embodiments,
the cut ends of the conductor 26.1 may be freed from the insulation
thereof; as shown in FIG. 8.
[0085] In at least one embodiment, the electrical filter 40p may
then be inserted at the location that has become free due to the
untwisting of the windings. As such, in one or more embodiments,
the electrical filter 40p may first be inserted into the space and
a polyimide tube 48 may then be guided through the lumen of the
co-radial coil feed line 26 and the electrical filter 40p in order
to hold the electrical filter 40p in place in a reliable and stable
manner. In at least one embodiment, the free wire ends of the cut
conductor 26.1 freed from the insulation may then be welded to the
proximal connection sleeve 42 and the distal connection sleeve 46
of the electrical filter 40p and may be electrically connected as
such; as shown in FIG. 9.
[0086] In one or more embodiments, the electrically insulating
sleeve 50 may then be slid in the form of a silicone tube over the
assembly thus produced.
[0087] According to at least one embodiment, to install the distal
electrical filter 40d, the co-radial coil feed line 26 may be
untwisted at the location of the proximal electrode pole 24p, a
further conductor 26.2 of the co-radial coil feed line 26 may be
cut, and the cut ends may be freed from the insulation thereof. At
the location of the proximal electrode pole 24p, by way of one or
more embodiments, two of the conductors of the co-radial coil feed
line may run without separation, whereas the conductor 26.1 that
contacts the electrically conductive sleeve of the proximal
electrode pole 24p may be provided with a non-insulated end, and
the conductor 26.2 that contacts the distal electrode pole 24d in
the region of the proximal electrode pole may include two separate
line ends freed from insulation; as shown in FIG. 11.
[0088] As discussed above regarding the proximal electrical filter
40p, in one or more embodiments, the distal electrical filter 40d
may be inserted into the space created by untwisting the co-radial
coil feed line 26, and the connection sleeves 42 and 46 of said
filter may be electrically connected by welding to the free, cut
ends of the conductor 26.2 freed from insulation; as shown in FIG.
12.
[0089] In at least one embodiment, the electrically conductive
sleeve forming the proximal electrode pole 24p may then be slid
onto the co-radial coil feed line 26 until directly above the
electrical filter 40d; as shown in FIGS. 12 and 13. In one or more
embodiments, the free end of the conductor 26.1, the dark
conductor, freed from insulation may be connected to the
corresponding electrically conductive sleeve 24p; as shown in FIG.
12.
[0090] In at least one embodiment, the part of the conductor 26.1,
of the dark conductor in the Figures, extending distally of the
proximal electrode pole 24p may not be further electrically
contacted and may be used exclusively such that no winding gaps are
created in the further co-radial coil feed line 26.
[0091] In order to avoid electrical short circuits, in one or more
embodiments of the invention, all non-insulated wire portions and
exposed contacts in the region of the electrically conductive
sleeve of the proximal electrode pole 24p may be insulated from one
another, for example by a corresponding parylene coating, a
spray-on coating or by squirting the region with silicone. In at
least one embodiment, further parts of the electrically insulating
outer sleeve 50 may then be fitted or slipped on in order to thus
finish the electrode line 20, as illustrated in FIG. 14.
[0092] 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 teaching. 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.
LIST OF REFERENCE SIGNS
[0093] 10--implantable heart stimulator [0094] 12--housing [0095]
14--terminal housing [0096] 16--contacts [0097] 20--electrode line
[0098] 22--point or tip electrode [0099] 24--ring electrode [0100]
22, 24--electrode poles [0101] 26.1, 26.2, 26.3, 26.4--electrical
conductors [0102] 26--co-radial coil feed line [0103] 28--plug
contact [0104] 40--electrical filter [0105] 42--proximal connection
sleeve [0106] 44--wire [0107] 46--distal connection sleeve [0108]
48--auxiliary element [0109] 50--electrically insulating sleeve
[0110] 52--wire
* * * * *