U.S. patent application number 12/026250 was filed with the patent office on 2008-06-05 for lead having composite insulative coating.
This patent application is currently assigned to Cardiac Pacemakers, Inc.. Invention is credited to Jon Schell.
Application Number | 20080132984 12/026250 |
Document ID | / |
Family ID | 25355235 |
Filed Date | 2008-06-05 |
United States Patent
Application |
20080132984 |
Kind Code |
A1 |
Schell; Jon |
June 5, 2008 |
LEAD HAVING COMPOSITE INSULATIVE COATING
Abstract
A lead assembly includes a flexible lead body which extends from
a proximal end to a distal end, the lead body includes one or more
conductors. The lead assembly further includes an electrode
assembly, and at least one coating of insulative material coated
directly on at least one conductor.
Inventors: |
Schell; Jon; (Brooklyn Park,
MN) |
Correspondence
Address: |
SCHWEGMAN, LUNDBERG & WOESSNER, P.A.
P.O. BOX 2938
MINNEAPOLIS
MN
55402
US
|
Assignee: |
Cardiac Pacemakers, Inc.
|
Family ID: |
25355235 |
Appl. No.: |
12/026250 |
Filed: |
February 5, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10717978 |
Nov 20, 2003 |
7337009 |
|
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12026250 |
|
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|
|
09870369 |
May 30, 2001 |
6701191 |
|
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10717978 |
|
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Current U.S.
Class: |
607/121 ;
29/592.1 |
Current CPC
Class: |
Y10T 29/49002 20150115;
A61N 1/056 20130101 |
Class at
Publication: |
607/121 ;
29/592.1 |
International
Class: |
A61N 1/00 20060101
A61N001/00 |
Claims
1. A method for making a lead assembly comprising: coupling at
least one electrode with one of a first conductor and a second
conductor; positioning the first conductor within the second
conductor; spraying a first composite insulative coating on a first
conductor outer surface, the first composite insulative coating
between the first conductor and the second conductor; and spraying
a second composite insulative coating on a second conductor outer
surface.
2. The method for making the lead assembly of claim 1, further
comprising: masking at least one of the first conductor and the
second conductor prior to spraying the first or second composite
insulative coatings; removing the masking to expose an uninsulated
conductor portion of at least one of the first conductor and the
second conductor after spraying the first or second composite
insulative coating; and coupling an electrode with the uninsulated
conductor portion.
3. The method for making the lead assembly of claim 1, wherein
positioning the first conductor within the second conductor
includes movably positioning the first conductor within the second
conductor, and the first conductor is movable relative to the
second conductor.
4. The method for making the lead assembly of claim 3, wherein
movably positioning the first conductor within the second conductor
includes rotatably positioning the first conductor within the
second conductor, and rotation of the first conductor relative to
the second conductor moves the first conductor along a longitudinal
axis of the second conductor.
5. The method for making the lead assembly of claim 1, wherein at
least one of spraying the first composite insulative coating and
spraying the second composite insulative coating includes applying
a plurality of composite insulative coating layers, and a first
composite insulative coating layer includes a first insulative
material and a second composite insulative coating layer includes a
second insulative material different from the first insulative
material.
6. The method for making the lead assembly of claim 1, wherein at
least one of spraying the first composite insulative coating and
spraying the second composite insulative coating includes applying
a composite insulative coating having a plurality of different
insulative materials.
7. The method for making the lead assembly of claim 1, wherein
positioning the first conductor within the second conductor
includes positioning a first braided conductor within a second
braided conductor.
8. A method for making a lead assembly comprising: coupling at
least one electrode with one of a first annular conductor and a
second annular conductor, the first annular conductor having a
first outer surface and a first inner surface, and the second
annular conductor having a second outer surface and a second inner
surface; disposing the first annular conductor within the second
annular conductor; dipping the first outer surface in a first
composite insulative coating material; forming a first composite
insulative layer on the first outer surface with the first
composite insulative coating material; dipping the second outer
surface in a second composite insulative coating material; and
forming a second composite insulative layer on the second outer
surface with the second composite insulative coating material.
9. The method for making the lead assembly of claim 8, wherein
disposing the first annular conductor within the second annular
conductor includes disposing a first coiled conductor within a
second braided conductor.
10. The method for making the lead assembly of claim 8, wherein at
least one of forming the first composite insulative layer on the
first outer surface and forming the second composite insulative
layer on the second outer surface includes solidifying at least one
of the first composite insulative coating material and the second
composite insulative coating material.
11. The method for making the lead assembly of claim 8, further
comprising: masking at least one of the first outer surface and the
second outer surface prior to dipping the at least one of the first
outer surface and the second outer surface; removing the masking to
expose an uninsulated conductor portion of at least one of the
first outer surface and the second outer surface after dipping the
at least one of the first outer surface and the second outer
surface; and coupling an electrode with the uninsulated conductor
portion.
12. The method for making the lead assembly of claim 8, wherein
disposing the first annular conductor within the second annular
conductor includes movably coupling the first annular conductor
with the second annular conductor.
13. The method for making the lead assembly of claim 12, wherein
movably coupling the first annular conductor with the second
annular conductor includes rotatably coupling the first annular
conductor with the second annular conductor, and rotation of the
first annular conductor relative to the second annular conductor
moves the first annular conductor along a longitudinal axis of the
second annular conductor.
14. The method for making the lead assembly of claim 8, wherein at
least one of dipping the first outer surface in the first composite
insulative coating material and dipping the second outer surface in
the second composite insulative coating material includes applying
a plurality of insulative coatings, and a first insulative coating
includes a first insulative material and a second insulative
coating includes a second insulative material different from the
first insulative material.
15. The method for making the lead assembly of claim 8, wherein at
least one of dipping the first outer surface in the first composite
insulative coating material and dipping the second outer surface in
the second composite insulative coating material includes applying
a composite coating material having a plurality of different
insulative materials.
16. A lead assembly comprising: a lead body; a first conductor
extending through the lead body, the first conductor including a
first conductor outer surface; a second conductor annularly
extending through the lead body, the second conductor positioned
around the first conductor, the second conductor including a second
conductor outer surface; at least one electrode coupled with one of
the first conductor and the second conductor; and means for
insulating the first conductor outer surface and the second
conductor outer surface.
17. The lead assembly of claim 16, wherein the means for insulating
the first conductor outer surface and the second conductor outer
surface includes a composite insulative coating sprayed on the
first conductor outer surface and the second conductive outer
surface.
18. The lead assembly of claim 17, wherein the composite insulative
coating includes a first composite insulative layer having a first
insulative material and a second composite insulative layer having
a second insulative material different from the first insulative
material, the second composite insulative layer on the first
composite insulative layer.
19. The lead assembly of claim 17, wherein the composite insulative
coating includes a first insulative material mixed with a second
insulative material.
20. The lead assembly of claim 16, wherein the first conductor
includes a braided conductor extending annularly through the lead
body.
21. The lead assembly of claim 20, wherein the braided conductor is
rotatable relative to the second conductor, the braided conductor
is coupled with an active fixation device, and rotation of the
braided conductor correspondingly moves the active fixation device
relative to the lead body along a lead body longitudinal axis.
22. The lead assembly of claim 16, wherein at least one of a first
conductor inner surface and a second conductor inner surface are
uninsulated.
Description
RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 10/717,978, filed on Nov. 20, 2003, which is a
continuation of U.S. patent application Ser. No. 09/870,369, filed
on May 30, 2001, the specifications of which are incorporated
herein by reference.
[0002] This application is related to U.S. patent application Ser.
No. 09/870,126, filed on May 30, 2001, now issued as U.S. Pat. No.
6,606,522 and to U.S. patent application Ser. No. 09/292,715, filed
on Apr. 15, 1999, now issued as U.S. Pat. No. 6,445,958, each of
which are incorporated by reference herein.
TECHNICAL FIELD
[0003] The present invention relates generally to leads for
stimulating or monitoring tissue. More particularly, it pertains to
a lead having composite tubing.
BACKGROUND
[0004] Leads implanted in or about the heart have been used to
reverse certain life threatening arrhythmias, or to stimulate
contraction of the heart. Electrical energy is applied to the heart
via the leads to return the heart to normal rhythm. Leads have also
been used to sense in the atrium or ventricle of the heart and to
deliver pacing pulses to the atrium or ventricle.
[0005] Cardiac pacing may be performed by the transvenous method or
by leads implanted directly onto the epicardium. Permanent
transvenous pacing is performed using a lead positioned within one
or more chambers of the heart. One or more leads may be positioned
in the ventricle or in the atrium through a subclavian vein, and
the lead terminal pins are attached to a pacemaker which is
implanted subcutaneously.
[0006] The lead includes a conductor, such as a coiled conductor,
to conduct energy from the pacemaker to the heart, and also signals
received from the heart. The lead further includes outer insulation
to insulate the conductor. Currently, providing the lead with
insulation is done by stringing silicone tubing over the lead.
Stringing involves the use of chemicals which swell the silicone
tubing, so that the coiled conductor can be pulled through the
tubing. As the chemicals evaporate, the tubing contracts around the
conductor. Stringing is a complicated manufacturing process which
also can result in axial gaps between the conductor and the
insulative tubing. The gaps contribute to the outer diameter of the
lead.
[0007] Accordingly, there is a need for a lead which allows for a
less complex manufacturing process and improved insulation. What is
also needed is a lead having a smaller outer diameter.
SUMMARY OF THE INVENTION
[0008] A lead assembly includes a flexible lead body which extends
from a proximal end to a distal end, the lead body includes one or
more conductors. The lead body includes an outer coating of
composite insulative material. The lead assembly further includes
an electrode assembly, and the outer coating of composite material
is coated directly on at least one conductor.
[0009] Several options for the lead assembly are as follows. For
instance, in one option, one or more conductors include a first
conductor and a second conductor, and at least one coating is
coated between the first conductor and the second conductor. In
another option, at least one of the conductors comprises a braided
conductor. In yet another option, the conductor extends from a
first end to a second end and has an intermediate section
therebetween, and a portion of the intermediate section has an
exposed, non-coated area. The lead assembly, in another option,
further includes one or more electrodes electrically coupled with
the exposed non-coated area. In another option, the composite
coating comprises a first coating and a second coating coated over
the first coating.
[0010] In another embodiment, a lead assembly includes a flexible
lead body which extends from a proximal end to a distal end, the
lead body includes one or more conductors, for instance a first
conductor and a second conductor. The flexible lead body comprises
a first coating disposed directly on a first conductor. The lead
assembly further includes an electrode assembly. In addition, at
least one second coating of insulative material is coated directly
on a second conductor, where the second coating is coated between
the first conductor and the second conductor.
[0011] Several options for the lead assembly are as follows. For
instance, the first conductor, in one option, comprises a braided
conductor. In another option, the first conductor extends from a
first end to a second end and has an intermediate section
therebetween, and a portion of the intermediate section has an
exposed, non-coated area, and optionally one or more electrodes are
mechanically coupled with the exposed non-coated area. In yet
another option, the first conductor comprises a means for extending
and retracting the electrode assembly. The lead assembly includes,
in another option, a third coating of insulative material coated
directly on the first coating of insulative material.
[0012] In another embodiment, a lead assembly includes a flexible
lead body which extends from a proximal end to a distal end, the
lead body includes one or more conductors, where at least one
conductor comprises a braided conductor configured to conduct
electrical signals. The lead assembly further includes at least one
electrode electrically coupled with at least one conductor, and at
least one coating of insulation coated directly on the braided
conductor.
[0013] Several options for the lead assembly are as follows. For
instance, in one option, a portion of the at least one coating is
removed from the braided conductor to reveal an exposed portion of
the braided conductor, and at least one electrode is electrically
and mechanically coupled with the exposed portion of the braided
conductor. In another option, the braided conductor is rotatable to
extend and/or retract at least one electrode. In yet another
option, the lead assembly further includes a second coating of
insulation coated between the braided conductor and a second
conductor, and the second coating is coated directly on the second
conductor. Alternatively, the lead assembly further includes an
outer coating of composite insulative coating, for example a first
coating and a second coating coated directly on the first
coating.
[0014] In another embodiment, a method comprises providing a first
conductor, forming an outer composite lead body over the first
conductor, which includes coating composite insulative material
directly on a first conductor. The method further includes coupling
at least one electrode with the first conductor.
[0015] Several options for the method are as follows. For instance,
in one option, the method further includes braiding multiple
conductors to form the first conductor, and optionally includes
rotating the first braided conductor, and extending the at least
one electrode. In another option, the method further includes
stripping insulative material from a portion of the first
conductor, and exposing a portion of the first conductor, and
optionally further mechanically and electrically coupling an
electrode to the exposed portion of the first conductor.
Alternatively, in another option, the method further includes
providing a second conductor, and coating a second coating directly
on the second conductor.
[0016] In another embodiment, a method comprises providing a first
conductor for a lead, the first conductor extending from a proximal
end to a distal end and having an inner diameter surface and an
outer diameter surface. The method further includes coating the
outer diameter surface of the first conductor with an insulative
coating, including leaving the inner diameter surface uncoated. A
second conductor is provided which is coaxial with the first
conductor, where the first conductor has a different outer diameter
than the second conductor. The method further includes coupling at
least one electrode with the first conductor, and coupling the
proximal end of the first conductor with an energy source
configured to stimulate tissue.
[0017] Several options for the method are as follows. For instance,
in one option, the method further includes rotating the conductor,
and extending the at least one electrode away from the lead. In
another option, the method further includes stripping insulative
material from a portion of the first conductor, and exposing a
portion of the first conductor, and optionally further mechanically
and electrically coupling an electrode to the exposed portion of
the first conductor. Alternatively, in another option, coating the
first conductor includes forming an outer lead body of composite
insulative material. In yet another option, the method further
includes coating an outer diameter of the second conductor with
insulative material.
[0018] The lead provides for a smaller lead body diameter due to
the elimination of gaps, and tolerance stack-up of the assembly.
The lead allows for the ability to start and stop tubing to allow
for transition areas of the outer insulation, allowing for the
device to have an isodiametric shape. Furthermore, the braided
conductors have multiple intersections which offer improved flex
fatigue properties. A further benefit is that the anode and cathode
are not co-radial, the cathode is suitable for use as a driving
mechanism for an extendable or retractable positive fixation
lead.
[0019] These and other embodiments, aspects, advantages, and
features of the present invention will be set forth in part in the
description which follows, and in part will become apparent to
those skilled in the art by reference to the following description
of the invention and referenced drawings or by practice of the
invention. The aspects, advantages, and features of the invention
are realized and attained by means of the instrumentalities,
procedures, and combinations particularly pointed out in the
appended claims and their equivalents.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] FIG. 1 illustrates a system for monitoring and stimulating
the heart constructed in accordance with one embodiment.
[0021] FIG. 2 is a perspective view of a portion of a lead assembly
constructed in accordance with one embodiment.
[0022] FIG. 3 is a cross-section of a portion of a lead assembly
constructed in accordance with one embodiment.
[0023] FIG. 4 is a cross-section of a lead assembly constructed in
accordance with another embodiment.
[0024] FIG. 5 is a cross-section of a lead assembly constructed in
accordance with another embodiment.
[0025] FIG. 6 is a block diagram illustrating a method in
accordance with another embodiment.
DESCRIPTION OF THE EMBODIMENTS
[0026] In the following detailed description, reference is made to
the accompanying drawings which form a part hereof, and in which is
shown by way of illustration specific embodiments in which the
invention may be practiced. These embodiments are described in
sufficient detail to enable those skilled in the art to practice
the invention, and it is to be understood that other embodiments
may be utilized and that structural changes may be made without
departing from the scope of the present invention. Therefore, the
following detailed description is not to be taken in a limiting
sense, and the scope of the present invention is defined by the
appended claims and their equivalents.
[0027] FIG. 1 illustrates a system 200 for delivering electrical
pulses to stimulate a heart 101 and/or for receiving electrical
pulses to monitor the heart 101. The system 200 includes a pulse
generator and signal sensor 109 and a lead 100. The lead 100
extends from a distal end 102 to a proximal end 104, and has an
intermediate portion 106 therebetween. The distal end 102 is
adapted for implantation within the heart of a patient and the
proximal end 104 has a terminal connector which electrically
connects the various electrodes and conductors within the lead body
115 to a pulse generator and signal sensor 109. The pulse generator
and signal sensor 109 contains electronics to sense various
electrical signals of the heart and also produce current pulses for
delivery to the heart 101. The pulse generator and signal sensor
109 is implanted pectorally, abdominally, or elsewhere within the
patient.
[0028] The lead 100 includes a lead body 115, for instance a
flexible lead body 115, at least one elongate conductor 150 (FIGS.
2 and 3) contained within the lead body 115, and at least one
electrode 120 (FIG. 4) coupled with the lead 100. The lead body
115, as further described below, includes an elongate body formed
of, for example, at least one polymer such as a medical grade
silicone rubber for translumenal insertion and access within a
living organism such as a patient. In one option, the lead body 115
is tubular and has an outer diameter that is small enough for
translumenal insertion into the coronary sinus 103 and/or great
cardiac vein 105.
[0029] The at least one electrode 120 is electrically coupled with
the elongate conductor 150 (FIGS. 2 and 3). Optionally, the
elongate conductor 150 comprises a coiled conductor and defines a
lumen therein and thereby is adapted to receive a stiffening stylet
that extends through the length of the lead 100.
[0030] The stylet is used to stiffen the lead 100, and is
manipulated to facilitate the insertion of the lead 100 into and
through a vein and through an intracardiac valve to advance the
distal end 102 of the lead 100 into, for example, the ventricle of
the heart 101. Optionally, a stylet knob is coupled with the stylet
for rotating the stylet, advancing the conductor into tissue of the
heart, and for manipulating the lead 100. Alternatively, the
elongate conductor 150 comprises other forms of conductors, such as
a cable conductor, or a braided conductor as further discussed
below.
[0031] FIG. 2 illustrates a portion of the lead shown in FIG. 1,
including the lead 100, and/or the lead 100 and the pulse generator
and signal sensor 109 (FIG. 1). The lead 100, in one option, is
used to chronically stimulate the heart 101 (FIG. 1), such that the
lead 100 is implanted on or about the heart 101 (FIG. 1) for long
periods of time. As mentioned above, the lead body 115 includes a
covering of insulation, and includes at least one elongate
conductor 150. In one option, the elongate conductor 150 extends
substantially along the entire length between the distal end 102
(FIG. 1) and the proximal end 104 (FIG. 1) of the lead 100. The
elongate conductor 150, in one option, includes a first inner
conductor 152 and a second conductor 154. In another option, the
first inner conductor 152 comprises a cathode of the system 200
(FIG. 1), and the second conductor 154 comprises an anode of the
system 200 (FIG. 1).
[0032] The first inner conductor 152, in one option, is co-axial
but not co-radial with the second conductor 154. For example, the
first inner conductor 152 is disposed within the second conductor
154. The first inner conductor 152 and/or the second conductor 154
comprises braided material, as further discussed below. An inner
layer of insulation 172 is disposed between the first inner
conductor and the second conductor 154. The inner layer of
insulation 172 is in addition to the lead body 115 which includes
at least one outer layer of insulation 170. Optionally, a second
inner layer of insulation 175 is disposed within the first inner
conductor 152.
[0033] The outer layer of insulation 170, in one option, is
disposed adjacent to the second conductor 154. The second conductor
154 is defined in part by an inner surface 156 and an outer surface
158. In one option, the outer layer of insulation 170 is disposed
directly on the outer surface 158 of the second conductor 154. For
instance, the outer layer of insulation 170 is coated directly on
the outer surface 158 of the second conductor 154 to form a
coating. Examples of coating process include, but are not limited
to, spray coating, dipping, brush coating. The coating, in one
option, comprises a composite coating 174 formed of two or more
insulative materials. It should be noted that more than two layers
of insulative materials could be utilized. In one example, as shown
in FIG. 3, the composite coating 174 comprises a first outer
coating 176 and a second outer coating 178 of material. In another
option, the second outer coating 178 is coated directly on the
first outer coating 176. In one option, one of the coatings
comprises PTFE, and the other coating comprises polyurethane. Other
suitable materials for use with the composite coating 174 include,
but are not limited to, silicone or elastomeric material.
[0034] Referring again to FIG. 2, the inner layer of insulation 172
is disposed directly on the first inner conductor 152. It should be
noted that more than one inner layer of insulation could be
incorporated into the lead. The first inner conductor 152 is
defined in part by an inner surface 151 and an outer surface 153.
As shown in FIG. 2, the inner layer of insulation 172 is disposed
directly on the outer surface 153 of the first inner conductor 152.
For instance, the inner layer of insulation 172 is coated directly
on the outer surface 153 of the first inner conductor 152.
Optionally, the inner layer of insulation 172 comprises a composite
coating. Suitable materials for the inner layer of insulation 172
include, but are not limited to, PTFE, ETFE, or polyimide.
[0035] In one example of the lead 100, the inner layer of
insulation 172 comprises a layer which is a minimum of 2 mm
thickness, for example, of PTFE. The second conductor 154 comprises
a braided conductor, for example having a 3 mm thickness. The first
outer coating 176 comprises a layer which is a minimum of 2 mm
thickness, for example, of PTFE, and the second outer coating 178
comprises polyurethane.
[0036] Referring to FIG. 4, the lead 100 is shown with a composite
outer coating 174 coated directly on the conductor 154. Optionally,
a portion 190 of the coating 174 is removed at an intermediate
section of the lead 100, and the conductor 154 is exposed. For
example, the portion 190 is removed by mechanical stripping, laser
stripping, or masking during the coating process. In yet another
option, one or more electrodes 192 are electrically and optionally
mechanically coupled with the exposed portion 190. For example, the
one or more electrodes 192 is welded or swaged with the conductor
154. In another example, the one or more electrodes 192 is crimped
or bonded with the conductor 154. The exposed portion 190 allows
for the outer body of the lead 100 to be made isodiametrically,
which allows for the lead 100 to be more easily inserted into a
patient.
[0037] FIG. 5 illustrates a distal end 102' of one option of the
lead 100'. The lead 100' includes an active fixation device 194
which allows for the distal end 102' of the lead 100' to be fixated
with tissue. In one option, the active fixation device 194
comprises a sharpened helical tip. In one option, the active
fixation device 194 is mechanically coupled directly or indirectly
with the conductor 150' such that rotating the conductor 150'
rotates the active fixation device 194. In one option, the
conductor 150' comprises a braided conductor, as discussed above.
In another option, the conductor 150' comprises a coated braided
conductor, as discussed above. The conductor 150' is, in one
example, welded or crimped with the active fixation device 194. The
conductor 150' comprises a non-coiled conductor of sufficient
rigidity to transmit torque provided at the proximal end of the
lead to the active fixation device 194 at the distal end of the
lead.
[0038] Referring to FIG. 6, a block diagram is shown illustrating a
method which includes coating a first conductor with a first
insulative layer, providing a second conductor over the first
insulative layer, and coating the second conductor with composite
insulative material. In one option, the second conductor is
provided directly on the first insulative layer, and/or the first
conductor is slidably received within the second conductor. The
method optionally includes coupling an active fixation device with
the second conductor, and rotating the second conductor and
rotating the active fixation device.
[0039] In another embodiment, a method comprises providing a first
conductor, forming an outer composite lead body over the first
conductor, which includes coating composite insulative material
directly on a first conductor. The method further includes coupling
at least one electrode with the first conductor. For example, a
ring electrode is slipped over the conductor and is electrically
and optionally mechanically coupled with the conductor.
[0040] Several options for the method are as follows. For instance,
in one option, the method further includes braiding multiple
conductors to form the first conductor, and optionally includes
rotating the first braided conductor, and extending the at least
one electrode. In another option, the method further includes
stripping insulative material from a portion of the first
conductor, and exposing a portion of the first conductor, and
optionally further mechanically and electrically coupling an
electrode to the exposed portion of the first conductor.
Alternatively, in another option, the method further includes
providing a second conductor, and coating a second coating directly
on the second conductor.
[0041] In another embodiment, a method comprises providing a first
conductor for a lead, the first conductor extending from a proximal
end to a distal end and having an inner diameter surface and an
outer diameter surface. The method further includes coating the
outer diameter surface of the first conductor with an insulative
coating, including leaving the inner diameter surface uncoated. A
second conductor is provided which is coaxial with the first
conductor, where the first conductor has a different outer diameter
than the second conductor. The method further includes coupling at
least one electrode with the first conductor, and coupling the
proximal end of the first conductor with an energy source
configured to stimulate tissue.
[0042] Several options for the method are as follows. For instance,
in one option, the method further includes rotating the conductor,
and extending the at least one electrode away from the lead. In
another option, the method further includes stripping insulative
material from a portion of the first conductor, and exposing a
portion of the first conductor, and optionally further mechanically
and electrically coupling an electrode to the exposed portion of
the first conductor. Alternatively, in another option, coating the
first conductor includes forming an outer lead body of composite
insulative material. In yet another option, the method further
includes coating an outer diameter of the second conductor with
insulative material.
[0043] Advantageously, the above described lead provides for a
smaller lead body diameter due to the elimination of gaps, and
tolerance stack-up of the assembly. Since the insulative material
is coated, rather than formed of tubing, the outer dimension of the
lead can be made smaller, and the lead can be made more cost
effectively. Furthermore, the coating of insulative material does
not involve the complex manufacturing processes involved with
tubing insulation. In addition, the above described device allows
for the ability to start and stop tubing to allow for transition
areas of the outer insulation, allowing for the device to have an
isodiametric shape. Furthermore, the braided conductors have
multiple intersections which offer improved flex fatigue
properties. A further benefit is that the anode and cathode are not
co-radial, the cathode is suitable for use as a driving mechanism
for an extendable or retractable positive fixation lead.
[0044] It is to be understood that the above description is
intended to be illustrative, and not restrictive. For instance, the
leads described above include, but are not limited to, tachy,
brady, or coronary sinus leads. It should be noted that features of
the various above-described embodiments may be interchanged to form
additional combinations. Many other embodiments will be apparent to
those of skill in the art upon reviewing the above description. The
scope of the invention should, therefore, be determined with
reference to the appended claims, along with the full scope of
equivalents to which such claims are entitled.
* * * * *