U.S. patent application number 12/211096 was filed with the patent office on 2009-03-19 for medical electrical lead.
This patent application is currently assigned to Medtronic, Inc.. Invention is credited to Gregory A. Boser, Kevin R. Seifert.
Application Number | 20090071687 12/211096 |
Document ID | / |
Family ID | 40242603 |
Filed Date | 2009-03-19 |
United States Patent
Application |
20090071687 |
Kind Code |
A1 |
Boser; Gregory A. ; et
al. |
March 19, 2009 |
MEDICAL ELECTRICAL LEAD
Abstract
A medical device lead is presented. The lead includes one or
more jacketed conductive elements. The jacket comprises one or more
covers. A first cover of expanded polytetrafluoroethylene (ePTFE)
is in direct contact with the at least one conductive element. At
least one conductive element and a ePTFE cover are coiled. The
coiled conductive element can substantially retain its original
coiled shape.
Inventors: |
Boser; Gregory A.;
(Richfield, MN) ; Seifert; Kevin R.; (Forest Lake,
MN) |
Correspondence
Address: |
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis
MN
55432
US
|
Assignee: |
Medtronic, Inc.
|
Family ID: |
40242603 |
Appl. No.: |
12/211096 |
Filed: |
September 15, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60972114 |
Sep 13, 2007 |
|
|
|
60973479 |
Sep 19, 2007 |
|
|
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Current U.S.
Class: |
174/110R ;
29/828 |
Current CPC
Class: |
Y10T 29/49204 20150115;
Y10T 29/49123 20150115; A61N 1/0563 20130101; A61N 1/05
20130101 |
Class at
Publication: |
174/110.R ;
29/828 |
International
Class: |
H01B 7/00 20060101
H01B007/00; H01B 13/20 20060101 H01B013/20 |
Claims
1 . A medical electrical lead comprising: a lead body that
comprises one or more insulated conductive elements; wherein at
least one conductive element includes a profiled longitudinal
element of polyether ketone (PEEK), the profiled longitudinal
element includes at least one protruding end, wherein the profiled
longitudinal element being coupled to a cover of ePTFE.
2. The medical electrical lead of claim 1 wherein the profiled
longitudinal element includes a plurality of protruding ends.
3. The medical electrical lead of claim 1 wherein the at least one
protruding end exhibits a flare about less than 90 degrees.
4. The medical electrical lead of claim 1 wherein the at least one
protruding end exhibits a flare about less than 60 degrees.
5. The medical electrical lead of claim 1 wherein the at least one
protruding end exhibits a flare about less than 45 degrees.
6. The medical electrical lead of claim 2 wherein the plurality of
protruding ends includes a first flared protruding end and a second
flared protruding end.
7. The medical electrical lead of claim 2 wherein the first
protruding end and a second protruding end form a first channel to
receive a first conductive element.
8. The medical electrical lead of claim 1 further comprising: a
second cover of polymeric material coupled to the first
longitudinal element, the second longitudinal element comprises one
of PEEK and ethylene-tetrafluoroethylene (ETFE).
9. The medical electrical lead of claim 1 further comprising: a
third longitudinal element of polymeric material coupled to the
first longitudinal element, the third longitudinal element
comprises one of PEEK and ETFE.
10. A method of forming a medical electrical lead comprising:
extruding PEEK over a mandrel to form at least one profiled
longitudinal element, the longitudinal element includes a first
protruding end and a second protruding end; cooling the at least
one longitudinal element; and placing at least one conductive
element between the first and the second protruding ends.
11. The method of claim 9, further comprising forming a second
longitudinal element comprising one of PEEK, and ETFE.
12. The method of claim 10 wherein the profiled longitudinal
element includes a plurality of flared protruding ends.
13. The method of claim 10 wherein the at least one flared
protruding end exhibits a flare about less than 90 degrees.
14. The method of claim 10 wherein the at least one flared
protruding end exhibits a flare about less than 60 degrees.
15. The method of claim 10 wherein the at least one flared
protruding end exhibits a flare about less than 45 degrees.
16. A medical electrical lead comprising: a lead body that
comprises one or more insulated conductive elements, wherein at
least one conductive element includes a profiled longitudinal
element of PEEK and ePTFE, the profiled longitudinal element
possessing a substantially elliptical cross-section.
17. The medical electrical lead of claim 16 wherein the profiled
longitudinal element comprises one or more channels formed by a set
of protruding ends.
18. The medical electrical lead of claim 16 wherein the profiled
longitudinal element comprises one or more channels formed by a set
of protruding ends.
19. A medical electrical lead comprising: a lead body that
comprises one or more insulated conductive elements, wherein at
least one conductive element includes a profiled longitudinal
element of ePTFE, the profiled longitudinal element possessing a
first, second, and third channel for receiving a first, second and
third conductive elements.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] The present application claims priority and other benefits
from U.S. Provisional Patent Application Ser. No. 60/973,479 filed
Sep. 19, 2007.
[0002] The present application also claims priority and other
benefits from U.S. Provisional Patent Application Ser. No.
60/972,114 filed Sep. 13, 2007.
TECHNICAL FIELD
[0003] The disclosure relates to implantable medical devices and,
more particularly, to implantable medical leads.
BACKGROUND
[0004] The human anatomy includes many types of tissues that can
either voluntarily or involuntarily, perform certain functions.
After disease, injury, or natural defects, certain tissues may no
longer operate within general anatomical norms. For example, after
disease, injury, time, or combinations thereof, the heart muscle
may begin to experience certain failures or deficiencies. Certain
failures or deficiencies can be corrected or treated with
implantable medical devices (IMDs), such as implantable pacemakers,
implantable cardioverter defibrillator (ICD) devices, cardiac
resynchronization therapy defibrillator devices, or combinations
thereof.
[0005] IMDs detect and deliver therapy for a variety of medical
conditions in patients. IMDs include implantable pulse generators
(IPGs) or implantable cardioverter-defibrillators (ICDs) that
deliver electrical stimuli to tissue of a patient. ICDs typically
comprise, inter alia, a control module, a capacitor, and a battery
that are housed in a hermetically sealed container with a lead
extending therefrom. It is generally known that the hermetically
sealed container can be implanted in a selected portion of the
anatomical structure, such as in a chest or abdominal wall, and the
lead can be inserted through various venous portions so that the
tip portion can be positioned at the selected position near or in
the muscle group. When therapy is required by a patient, the
control module signals the battery to charge the capacitor, which
in turn discharges electrical stimuli to tissue of a patient
through via electrodes disposed on the lead, e.g., typically near
the distal end of the lead. Typically, a medical electrical lead
includes a flexible elongated body with one or more insulated
elongated conductors. Each conductor electrically couples a sensing
and/or a stimulation electrode of the lead to the control module
through a connector module. It is desirable to develop implantable
medical electrical leads with new lead body subassemblies.
BRIEF DESCRIPTION OF DRAWINGS
[0006] Aspects and features of the present invention will be
appreciated as the same becomes better understood by reference to
the following detailed description of the embodiments of the
invention when considered in connection with the accompanying
drawings, wherein:
[0007] FIG. 1 is a conceptual schematic view of an implantable
medical device in which a medical electrical lead extends
therefrom;
[0008] FIG. 2 is a schematic view of a medical electrical lead;
[0009] FIG. 3A is a schematic view of a distal end of the medical
electrical lead;
[0010] FIG. 3B is a cross-sectional view taken along plane A-A of
the distal end of the medical electrical lead depicted in FIG.
3A;
[0011] FIG. 4A is a schematic view of a jacket that surrounds one
or more conductive elements in a medical electrical lead;
[0012] FIG. 4B is a schematic sectional view of the jacket depicted
in FIG. 4A;
[0013] FIG. 5A is a schematic view of an exemplary insulated
conductive element;
[0014] FIG. 5B is a cross-sectional view of the insulated
conductive element depicted in FIG. 5A;
[0015] FIG. 6A is a schematic view of an exemplary insulated
multi-conductor element;
[0016] FIG. 6B is a schematic cross-sectional view of an exemplary
insulated multi-conductor element depicted in FIG. 6A;
[0017] FIG. 7A is a schematic view of another exemplary insulated
multi-conductor element;
[0018] FIG. 7B is a schematic cross-sectional view of an exemplary
insulated multi-conductor element depicted in FIG. 7A;
[0019] FIG. 8A is a schematic view of an exemplary insulated
multi-conductor element before its stretched;
[0020] FIG. 8B is a schematic view of an exemplary insulated
multi-conductor element being stretched;
[0021] FIG. 8C is an exemplary insulated multi-conductor element in
a relaxed position and returning to its original coiled shape;
[0022] FIG. 9 is a schematic view of an exemplary insulated
multi-conductor element wrapped around a tubular insulative element
or a coil liner;
[0023] FIG. 10A is a schematic view of yet another exemplary
insulated multi-conductor element wrapped around a mandrel;
[0024] FIG. 10B is a cross-sectional view of the insulated
conductive element depicted in FIG. 10A;
[0025] FIG. 11 is a flow diagram for forming a coiled jacketed
conductive element;
[0026] FIG. 12A depicts a schematic oblique view of a portion of a
lead body that includes at least one profile-shaped longitudinal
element with channels for placement of one or more elongate
conductive elements;
[0027] FIG. 12B is a cross-sectional view of the portion of a lead
body depicted in FIG. 12A;
[0028] FIG. 13A depicts a schematic oblique view of a portion of a
lead body that includes at least one profile-shaped longitudinal
element with channels for placement of one or more elongate
conductive elements;
[0029] FIG. 13B is a side view of a longitudinal protruding end,
depicted in FIG. 13A, used to form longitudinal channels for
placement of one or more elongate conductive elements; and
[0030] FIG. 13B is a side view of another longitudinal protruding
end, depicted in FIG. 13A, used to form longitudinal channels for
placement of one or more elongate conductive elements.
DETAILED DESCRIPTION
[0031] The present disclosure relates to a medical electrical lead
that includes a lead body. The lead body comprises one or more
insulated conductive elements. At least one conductive element
includes a profiled longitudinal element of comprising polyether
ketone (PEEK). The profiled longitudinal element includes at least
one protruding end. The profiled longitudinal element is coupled to
a cover of ePTFE.
[0032] The principles described herein are applicable to all types
of medical electrical leads. For example, the disclosure applies to
cardiovascular leads (e.g. high voltage leads, low voltage leads
etc.), neurological leads, or other suitable applications.
[0033] FIG. 1 depicts a medical device system 100. A medical device
system 100 includes a medical device housing 102 having a connector
module 104 (e.g. international standard (IS)-1, defibrillation
(DF)-1, IS-4 etc.) that electrically couples various internal
electrical components housed in medical device housing 102 to a
proximal end 105 of a medical electrical lead 106. A medical device
system 100 may comprise any of a wide variety of medical devices
that include one or more medical lead(s) 106 and circuitry coupled
to the medical electrical lead(s) 106. An exemplary medical device
system 100 can take the form of an implantable cardiac pacemaker,
an implantable cardioverter, an implantable defibrillator, an
implantable cardiac pacemaker-cardioverter-defibrillator (PCD), a
neurostimulator, a tissue and/or muscle stimulator. IMDs are
implanted in a patient in an appropriate location. Exemplary IMDs
are commercially available as including one generally known to
those skilled in the art, such as the Medtronic CONCERTO.TM.,
SENSIA.TM., VIRTUOSO.TM., RESTORE.TM., RESTORE ULTRA.TM., sold by
Medtronic, Inc. of Minnesota. Non-implantable medical devices or
other types of devices may also utilize batteries such as external
drug pumps, hearing aids and patient monitoring devices or other
suitable devices. Medical device system 100 may deliver, for
example, pacing, cardioversion or defibrillation pulses to a
patient via electrodes 108 disposed on distal end 107 of one or
more lead(s) 106. Specifically, lead 106 may position one or more
electrodes 108 with respect to various cardiac locations so that
medical device system 100 can deliver electrical stimuli to the
appropriate locations.
[0034] FIG. 2 depicts lead 106. Lead 106 includes a lead body 117
that extends from proximal end 105 to a distal end 107. Lead body
117 can include one or more connectors 101, and one or more
jacketed conductive elements 112a-d. A jacket (also referred to as
a liner, longitudinal element, coating) extends along and
longitudinally around the conductive elements 112a-d and can serve
to contain or mechanically constrain one or more conductive
elements 112a-d. A jacket can also insulate one or more conductive
elements 112a-d. Connector module 104 can contain connectors 122,
such as set screws, serve to electrically and mechanically connect
conductive elements 112a-d to ports (not shown) of connector module
104. Conductive element 112c (also referred to as a "conductor
coil," torque coil", "distal tip conductor") can extend to the
distal end 107 and can optionally be coupled to a retractable
and/or extendable helical tip. One or more conductive elements
112a,b serve as, or are connected to, defibrillation coils 103a,b
that deliver electrical stimuli, when necessary, to tissue of a
patient. Lead 106 can also include a conductive element 112d that
extends from the proximal end 105 to ring electrode 118 while
another conductive element 112c extends from proximal end 105 to
tip electrode 120.
[0035] Electrically conductive elements 112a-d can include coils,
wires, coil wound around a filament, cables, conductors or other
suitable members. Conductive elements 112a-d can comprise platinum,
platinum alloys, titanium, titanium alloys, tantalum, tantalum
alloys, cobalt alloys (e.g. MP35N, a nickel-cobalt alloy etc.),
copper alloys, silver alloys, gold, silver, stainless steel,
magnesium-nickel alloys, palladium, palladium alloys or other
suitable materials. Electrically conductive element 112a-d is
covered, or substantially covered, longitudinally with a jacket 130
(also referred to as a liner, a longitudinal element, a
longitudinal member, a coating, a tubular element, a tube or a
cylindrical element). In yet another embodiment, each conductive
element 112a-d is surrounded by a tubular element, which can
possess a circular or a non-circular cross-section. An outercover
or outerjacket in a lead body 117 can exhibit a non-circular
cross-section.
[0036] Typically, the outer surface of electrodes 108 such as the
ring electrode 118, the tip electrode 120, and the defibrillation
coils 103a,b are exposed or not covered by a jacket 130 or liner so
that electrodes 108 can sense and/or deliver electrical stimuli to
tissue of a patient. A sharpened distal tip (not shown) of tip
electrode 120 facilitates fixation of the distal end of helically
shaped tip electrode 120 into tissue of a patient.
[0037] Referring to FIGS. 3A-3B, and 4A-4B, lead body 117 can
include one or more jackets 130 and one or more conductive elements
112a,b,d. In one embodiment, lead body 117 comprises one or more
jackets 130 disposed in another jacket 130. In still yet another
embodiment, lead body 117 comprises one or more jackets 130 with an
outer cover 140 that surrounds the one or more jackets 130.
[0038] Each jacket 130 can include one or more covers, as depicted
in FIGS. 4A-4B with cross-sectional segment 128. Each cover 146,
148, 150, and 152 can comprise one or more layers of polymeric
compounds. Numerous embodiments of jacket 130 or liner are
summarized in Table 1 and described in greater detail below. The
first embodiment listed in Table 1 relates to a jacket 130 formed
of a first, second and third covers 144, 146, 148. First cover 144
of PEEK can possess a thickness that ranges from about 0.0005
inches to about 0.0015 inches of extruded PEEK. In another
embodiment, first cover 144 can possess a thickness that ranges
from about 0.00020 inches to about 0.001 inches. First cover 144 of
PEEK is formed by extruding the PEEK over a conductive element
112a,b,d. After the first cover 144 of PEEK has been formed, a
second cover 146 of ePTFE (tape-wrapped, porous), commercially
available from Zeus located in Orangeburg, S.C. or C. R. Bard
located in Tempe, Ariz., is introduced over the first cover 144.
Porous ePTFE possesses a density of less than 2.2 grams/cubic
centimeters. Second cover 146 can possess a thickness that ranges
from about 0.00020 inches to about 0.001 inches. A third cover 148
of PEEK is introduced over the second cover 146 in which the third
cover 148 can possess a thickness that ranges from about 0.00020
inches to about 0.001 inches. A composite structure is composed of
the first, second, and third covers 144, 146, 148 respectively,
over the conductive element 112a,b,d. The composite structure is
formed into a coil shape and then mechanically constrained, as
previously described.
[0039] The composite structure then undergoes thermal annealing or
stress relieving in a chamber. The temperature in the chamber is
about 130.degree. C. to about 210.degree. C. for about 30 seconds
to about 30 minutes to allow the polymeric material to form jacket
130 around conductive element 112a,b,d. Thereafter, the mechanical
constraint is removed.
[0040] The second embodiment listed in Table 1 relates to a jacket
130 formed of a first, second and third covers 144, 146, 148. First
cover 144 of PEEK can possess a thickness that ranges from about
0.0005 inches to about 0.0015 inches of extruded PEEK. In another
embodiment, first cover 144 can possess a thickness that ranges
from about 0.00020 inches to about 0.001 inches. First cover 144 of
PEEK is formed by extruding the PEEK over a conductive element
112a,b,d. After the first cover 144 of PEEK has been formed, a
second cover 146 of ePTFE (tape-wrapped, porous) is introduced over
the first cover 144. Second cover 146 can possess a thickness that
ranges from about 0.00020 inches to about 0.001 inches. A third
cover 148 of ETFE is introduced over the second cover 146 in which
the third cover 148 can possess a thickness that ranges from about
0.00020 inches to about 0.001 inches. A composite structure is
composed of the first, second, and third covers 144, 146, 148
respectively, over the conductive element 112a,b,d. The composite
structure is formed into a coil shape and then mechanically
constrained, as previously described.
[0041] The composite structure then undergoes thermal annealing or
stress relieving in a chamber. The temperature in the chamber is
about 130.degree. C. to about 210.degree. C. for about 30 seconds
to about 30 minutes to allow the polymeric material to form jacket
130 around conductive element 112a,b,d. Thereafter, the mechanical
constraint is removed.
[0042] The third embodiment listed in Table 1 relates to a jacket
130 formed of a first, second covers 144, 146. First cover 144 of
PEEK can possess a thickness that ranges from about 0.0005 inches
to about 0.0015 inches of extruded PEEK. In another embodiment,
first cover 144 can possess a thickness that ranges from about
0.00020 inches to about 0.001 inches. First cover 144 of PEEK is
formed by extruding the PEEK over a conductive element 112a,b,d.
After the first cover 144 of PEEK has been formed, a second cover
146 of ePTFE (tape-wrapped, porous) is introduced over the first
cover 144. Second cover 146 can possess a thickness that ranges
from about 0.00020 inches to about 0.001 inches. A third cover 148
of PEEK is introduced over the second cover 146 in which the third
cover 148 can possess a thickness that ranges from about 0.00020
inches to about 0.001 inches. A composite structure is composed of
the first, and second covers 144, 146, 148 respectively, over the
conductive element 112a,b,d. The composite structure is formed into
a coil shape and then mechanically constrained, as previously
described.
[0043] The composite structure then undergoes thermal annealing or
stress relieving in a chamber. The temperature in the chamber is
about 130.degree. C. to about 210.degree. C. for about 30 seconds
to about 30 minutes to allow the polymeric material to form jacket
130 around conductive element 112a,b,d. Thereafter, the mechanical
constraint is removed.
[0044] The fourth embodiment listed in Table 1 relates to a jacket
130 formed of a first, second and third covers 144, 146, 148. First
cover 144 of PEEK can possess a thickness that ranges from about
0.0005 inches to about 0.0015 inches of extruded PEEK. In another
embodiment, first cover 144 can possess a thickness that ranges
from about 0.00020 inches to about 0.001 inches. First cover 144 of
PEEK is formed by extruding the PEEK over a conductive element
112a,b,d. After the first cover 144 of PEEK has been formed, a
second cover 146 of ePTFE (tape-wrapped, nonporous) is introduced
over the first cover 144. Nonporous ePTFE possesses a density of
about 2.2 grams/cubic centimeters. Second cover 146 can possess a
thickness that ranges from about 0.00020 inches to about 0.001
inches. A third cover 148 of PEEK is introduced over the second
cover 146 in which the third cover 148 can possess a thickness that
ranges from about 0.00020 inches to about 0.001 inches. A composite
structure is composed of the first, second, and third covers 144,
146, 148 respectively, over the conductive element 112a,b,d. The
composite structure is formed into a coil shape and then
mechanically constrained, as previously described.
[0045] The composite structure then undergoes thermal annealing or
stress relieving in a chamber. The temperature in the chamber is
about 130.degree. C. to about 210.degree. C. for about 30 seconds
to about 30 minutes to allow the polymeric material to form jacket
130 around conductive element 112a,b,d. Thereafter, the mechanical
constraint is removed.
[0046] The fifth embodiment listed in Table 1 relates to a jacket
130 formed of a first, second and third covers 144, 146, 148. First
cover 144 of PEEK can possess a thickness that ranges from about
0.0005 inches to about 0.0015 inches of extruded PEEK. In another
embodiment, first cover 144 can possess a thickness that ranges
from about 0.00020 inches to about 0.001 inches. First cover 144 of
PEEK is formed by extruding the PEEK over a conductive element
112a,b,d. After the first cover 144 of PEEK has been formed, a
second cover 146 of ePTFE (tape-wrapped, nonporous) is introduced
over the first cover 144. Second cover 146 can possess a thickness
that ranges from about 0.00020 inches to about 0.001 inches. A
third cover 148 of ETFE is introduced over the second cover 146 in
which the third cover 148 can possess a thickness that ranges from
about 0.00020 inches to about 0.001 inches. A composite structure
is composed of the first, second, and third covers 144, 146, 148
respectively, over the conductive element 112a,b,d. The composite
structure is formed into a coil shape and then mechanically
constrained, as previously described.
[0047] The composite structure then undergoes thermal annealing or
stress relieving in a chamber. The temperature in the chamber is
about 130.degree. C. to about 210.degree. C. for about 30 seconds
to about 30 minutes to allow the polymeric material to form jacket
130 around conductive element 112a,b,d. Thereafter, the mechanical
constraint is removed.
[0048] The sixth embodiment listed in Table 1 relates to a jacket
130 formed of a first, second and third covers 144, 146, 148. First
cover 144 of PEEK can possess a thickness that ranges from about
0.0005 inches to about 0.0015 inches of extruded PEEK. In another
embodiment, first cover 144 can possess a thickness that ranges
from about 0.00020 inches to about 0.001 inches. First cover 144 of
PEEK is formed by extruding the PEEK over a conductive element
112a,b,d. After the first cover 144 of PEEK has been formed, a
second cover 146 of ePTFE (tape-wrapped, nonporous) is introduced
over the first cover 144. Second cover 146 can possess a thickness
that ranges from about 0.00020 inches to about 0.001 inches. A
third cover 148 of EFEP is introduced over the second cover 146 in
which the third cover 148 can possess a thickness that ranges from
about 0.00020 inches to about 0.001 inches. A composite structure
is composed of the first, second, and third covers 144, 146, 148
respectively, over the conductive element 112a,b,d. The composite
structure is formed into a coil shape and then mechanically
constrained, as previously described.
[0049] The composite structure then undergoes thermal annealing or
stress relieving in a chamber. The temperature in the chamber is
about 130.degree. C. to about 210.degree. C. for about 30 seconds
to about 30 minutes to allow the polymeric material to form jacket
130 around conductive element 112a,b,d. Thereafter, the mechanical
constraint is removed.
[0050] The seventh embodiment listed in Table 1 relates to a jacket
130 formed of a first, second covers 144, 146. First cover 144 of
PEEK can possess a thickness that ranges from about 0.0005 inches
to about 0.0015 inches of extruded PEEK. In another embodiment,
first cover 144 can possess a thickness that ranges from about
0.00020 inches to about 0.001 inches. First cover 144 of PEEK is
formed by extruding the PEEK over a conductive element 112a,b,d.
After the first cover 144 of PEEK has been formed, a second cover
146 of ePTFE-FEP layered composite is introduced over the first
cover 144. Second cover 146 can possess a thickness that ranges
from about 0.00020 inches to about 0.001 inches. A third cover 148
of PEEK is introduced over the second cover 146 in which the third
cover 148 can possess a thickness that ranges from about 0.00020
inches to about 0.001 inches. A composite structure is composed of
the first, and second covers 144, 146, 148 respectively, over the
conductive element 112a,b,d. The composite structure is formed into
a coil shape and then mechanically constrained, as previously
described.
[0051] The composite structure then undergoes thermal annealing or
stress relieving in a chamber. The temperature in the chamber is
about 130.degree. C. to about 210.degree. C. for about 30 seconds
to about 30 minutes to allow the polymeric material to form jacket
130 around conductive element 112a,b,d. Thereafter, the mechanical
constraint is removed.
[0052] The eighth embodiment listed in Table 1 relates to a jacket
130 formed of a first, second and third covers 144, 146, 148. First
cover 144 of PEEK can possess a thickness that ranges from about
0.0005 inches to about 0.0015 inches of extruded PEEK. In another
embodiment, first cover 144 can possess a thickness that ranges
from about 0.00020 inches to about 0.001 inches. First cover 144 of
PEEK is formed by extruding the PEEK over a conductive element
112a,b,d. After the first cover 144 of PEEK has been formed, a
second cover 146 of ePTFE-FEP layered composite is introduced over
the first cover 144. Second cover 146 can possess a thickness that
ranges from about 0.00020 inches to about 0.001 inches. A third
cover 148 of ETFE is introduced over the second cover 146 in which
the third cover 148 can possess a thickness that ranges from about
0.00020 inches to about 0.001 inches. A composite structure is
composed of the first, second, and third covers 144, 146, 148
respectively, over the conductive element 112a,b,d. The composite
structure is formed into a coil shape and then mechanically
constrained, as previously described.
[0053] The composite structure then undergoes thermal annealing or
stress relieving in a chamber. The temperature in the chamber is
about 130.degree. C. to about 210.degree. C. for about 30 seconds
to about 30 minutes to allow the polymeric material to form jacket
130 around conductive element 112a,b,d. Thereafter, the mechanical
constraint is removed.
[0054] The ninth embodiment listed in Table 1 relates to a jacket
130 formed of a first, second and third covers 144,146,148. First
cover 144 of PEEK can possess a thickness that ranges from about
0.0005 inches to about 0.0015 inches of extruded PEEK. In another
embodiment, first cover 144 can possess a thickness that ranges
from about 0.00020 inches to about 0.001 inches. First cover 144 of
PEEK is formed by extruding the PEEK over a conductive element
112a,b,d. After the first cover 144 of PEEK has been formed, a
second cover 146 of ePTFE-FEP layered composite is introduced over
the first cover 144. Second cover 146 can possess a thickness that
ranges from about 0.00020 inches to about 0.001 inches. A third
cover 148 of EFEP is introduced over the second cover 146 in which
the third cover 148 can possess a thickness that ranges from about
0.00020 inches to about 0.001 inches. A composite structure is
composed of the first, second, and third covers 144, 146, 148
respectively, over the conductive element 112a,b,d. The composite
structure is formed into a coil shape and then mechanically
constrained, as previously described.
[0055] The composite structure then undergoes thermal annealing or
stress relieving in a chamber. The temperature in the chamber is
about 130.degree. C. to about 210.degree. C. for about 30 seconds
to about 30 minutes to allow the polymeric material to form jacket
130 around conductive element 112a,b,d. Thereafter, the mechanical
constraint is removed.
[0056] Table 1, presented below, summarizes the various embodiments
of jacket 130.
TABLE-US-00001 TABLE 1 Embodiments of jacket 130 that comprise one
or more polymeric compounds No. First Cover Second Cover Third
Cover N Cover 1 PEEK ePTFE (tape-wrapped, PEEK porous) 2 PEEK ePTFE
(tape-wrapped, ETFE porous) 3 PEEK ePTFE (tape-wrapped, nonporous)
4 PEEK ePTFE (tape-wrapped, PEEK nonporous) 5 PEEK ePTFE
(tape-wrapped, ETFE nonporous) 6 PEEK ePTFE (tape-wrapped, EFEP
nonporous) 7 PEEK ePTFE-FEP layered composite 8 PEEK ePTFE-FEP
layered ETFE composite 9 PEEK ePTFE-FEP layered EFEP composite
[0057] The insulated conductive element formed through jacket 130
over conductive element 112a,b,d can be helically wrapped around a
mandrel (not shown). After winding the insulated cable onto the
mandrel and mechanically restraining this composite structure, the
polymeric material over the conductive element (e.g. cable etc.)
can be annealed to minimize springback and allow the conductive
element (e.g. cable etc.) to retain its coiled shape. After being
removed from the mandrel, the conductive element (e.g. cable etc.)
retains its coiled shape.
[0058] Insulated conductive element 200 is depicted in FIGS. 5A-5B.
Insulated conductive element 200 includes a conductive element
112a,b,d (i.e. cable, coiled cable etc.) with a thin polymeric
material 204 or cover that has been thermally processed (e.g.
annealed etc.) to conductive element 112a,b,d. Polymeric material
204 comprises a first and second covers 124a,124b. Conductive
element 112a,b,d has an outer diameter of about 0.09 inches or
less. In one embodiment, conductive element 112a,b,d can be a
1.times.19 cable construction with filaments composed of MP35N/Ag
core.
[0059] Referring to FIGS. 6A-6B, an insulated conductive element
300 is depicted that comprises a set of conductors 302a-c (i.e.
three conductors) and an insulative layer or cover 304. Conductive
element 300 such as a 1.times.19 cable MP35N/Ag core and has an
outer diameter of about 0.055 inches. Insulative layer 304
comprises a layer of PEEK and a layer of ePTFE.
[0060] Referring to FIG. 7A-7B, insulated conductive element 400
comprises a set of conductors 402a-e (i.e. five conductors) and an
insulative layer or cover 404. Conductive element 400 has an outer
diameter of about 0.060 inches and is a 1.times.19 cable.
Insulative layer 404 comprises a layer of PEEK and a layer of
ePTFE.
[0061] Referring to FIGS. 8A-8C, jacketed conductive element 500 is
shown as retaining its coiled shape despite being stretched.
Conductive element 500 comprises a 1.times.19 cable construction
with filaments composed of MP35N/Ag core with an insulative or
jacketed layer, coating or cover. The insulative layer comprises a
layer of PEEK and a layer of ePTFE. In one embodiment, each layer
of PEEK and ePTFE is about 0.0008 inches or less. In one
embodiment, each layer of PEEK and ePTFE is about 0.002 inches or
less. Referring to FIG. 8A, insulated conductive element 500 is
depicted in a relaxed position (FIG. 8A) over a mandrel. While over
the mandrel, conductive element 500 is thermally annealed.
Referring to FIG. 8B, insulated conductive element 500 is depicted
in a stretched position. Thereafter, insulated conductive element
500 moves to a relaxed position after being stretched (FIG. 8C).
The insulated conductive element 500 retains 99% or more of its
original coiled shape. In another embodiment, insulated conductive
element 500 comprises 95% or more of its original coiled shape.
[0062] Referring to FIG. 9, insulated conductive element 600 is
helically wrapped around a coil liner 130. Insulated conductive
element 600 comprises a set of jacketed conductors 602 (i.e. five
conductors cable-coil). Referring to FIG. 10A-10B, insulated
conductive element 700 is helically wrapped around a mandrel 702.
Insulated conductive element 700 comprises a set of conductors 702
(i.e. five conductors) and an insulative layer or cover.
[0063] FIG. 11 is a flow diagram of an exemplary
computer-implemented method or a manual process to form at least
one cover of PEEK over the conductive element. At block 800, a
counter, x, is initiated to 1 in order to count the number polymer
covers formed over a conductive element. At block 810, a polymer is
extruded (also referred to as introduced) over the conductive
element. Polymers with high elastic modulus (i.e. stiffness) such
as PEEK are preferred since PEEK can be annealed or stress relieved
to increase crystallinity and set the coil shape in conductive
element 112a-c. At block 820, the polymer cover can undergo an
optional thermal process.
[0064] At block 830, the counter, X, is incremented by adding 1 to
the previous value of X. At block 840, a determination is made as
to whether a sufficient number of polymer covers have been formed
over the conductive element. In this embodiment, a determination is
made as to whether X=N where N equals the number of pre-selected
covers to be added to the conductive element. If X does not equal
N, the process control returns to block 810 to extrude the same or
different polymer over the previous polymer cover. If x does equal
N, then the process goes to block 850, where the jacketed
conductive element undergoes coiling, as previously described. If x
does not equal N, the process returns to introducing another
polymeric cover over the conductive element 112a-d. If x does equal
N, no additional polymer covers are introduced over the conductive
element 112a-d. At block 850, the jacketed conductive element is
formed into a coil. At block 860, the coiled jacketed conductive
element can undergo an optional thermal process. If the method is
implemented on a computer, the number of polymeric covers formed
over the conductive element and/or the types of polymeric material
used for each cover can be displayed on a graphical user interface
of a computer. The computer-implemented instructions are executed
on a processor of a computer.
[0065] FIG. 12 depicts a distal portion of another lead body 900
that includes at least one profile-shaped longitudinal element,
which provides channels for placement of one or more elongate
conductive elements, and maintains physical and electrical
isolation of each elongate conductive element. If the
profile-shaped longitudinal element is bonded to the outer
insulative tubular longitudinal element at the top of the profile
features such as at each rib or protruding end, the resulting lead
body 900 is effectively a multilumen construction which can possess
a reduced diameter compared to lead bodies utilizing extruded
multilumen tubing. The profile-shaped longitudinal element in lead
body 900 can also provide enhanced kink resistance and flexibility
compared with lead bodies utilizing non-profiled shaped
longitudinal elements.
[0066] Lead body 900 can include an elongated longitudinal element
930 and one or more elongated conductive elements 112a-f (e.g.
cable, coil etc.). Conductive elements 112a-f, also referred to as
first, second, third, fourth, and a Nth conductive elements, where
N is a whole number, can be individually disposed in polymeric
longitudinal elements 930.
[0067] A longitudinal element 930, which extends along and
longitudinally around the conductive elements 112a-f, can serve to
contain or mechanically constrain one or more conductive elements
112a-f. Longitudinal element 930 can also insulate one or more
conductive elements 112a-f. Longitudinal element 930 (also referred
to as a liner, jacket, coating etc.) can comprise at least one
profiled-shaped longitudinal element 904c formed from an extrusion
process. In another embodiment, as depicted, longitudinal element
930 can include at least one profiled longitudinal element 904c
along with one or more other covers 904a,b,d.
[0068] Longitudinal element 930 can be formed by extruding a
polymeric material, selected from Table 1, such as PEEK, over a
mandrel. For example, after the polymeric material is heated in the
barrel of the extruder until it attains or exceeds its melt
temperature, the polymeric material is simultaneously extruded
through a die of the extruder over the mandrel while the mandrel
continues to move away from the extruder and/or the mandrel moves
radially. The polymeric material then forms into a first cover 904b
(also referred to as first longitudinal element) over the mandrel.
After formation of first cover 904b, the polymeric material is
allowed to cool. There are numerous ways to cool the polymeric
material. For example, the first cover 904b can be air cooled,
which is a slow cooling process. Alternatively, the first cover
904b can be placed in a cool water bath. In yet another embodiment,
the first cover 904b and the mandrel can be placed into a cooler
such as a refrigeration unit to quickly cool the polymeric
material.
[0069] After the first cover 904b has cooled, a second cover 904c
is formed through a second extrusion process. The polymeric
material is extruded through another die over the first cover 904b.
The second cover 904c (also referred to as a second longitudinal
element) is allowed to cool in a manner, as previously described.
As depicted, in one embodiment, second cover 904c can comprise a
longitudinal tube 908 with a set of elongated protruding ends 907
or ribs extending from the longitudinal tube. Second cover 904c,
comprising longitudinal tube 908 with a set of elongated protruding
ends 907, is a single extruded piece or element. Recessed regions
910 are located between each protruding end 907. In one embodiment,
recessed regions 910 extend from the proximal to the distal end of
the lead body.
[0070] In one embodiment, protruding ends 907 are substantially
rounded. In another embodiment, protruding ends 907 are depicted as
being substantially cylindrically shaped with rounded ends.
[0071] After second cover 904c has cooled, a set of lined or
insulated conductive elements 112a-f, are helically served or wound
within recessed areas 912 disposed between protruding ends 907.
Serving or winding insulated conductive elements 112a-f into
recessed areas 912 can be performed manually or automatically
through a winding machine while optionally simultaneously
introducing third cover 904d (also referred to as third
longitudinal element, outer cover or overlay). In one embodiment,
third cover 904d is extruded over insulated conductive elements
112a-f. Third cover 904d is then allowed to cool in a manner as
previously described. In another embodiment, third cover 904d is
produced or formed separately via extrusion and slid over insulated
conductive elements 112a-f. In yet another embodiment, the
polymeric material, selected from Table 1, is wrapped or served
over insulated conductive elements 112a-f. The mandrel is then
removed from jacket 930, which leaves a longitudinal lumen 905 in
lead body 900 that can extend from the proximal to the distal ends
of the lead body 900. Lumen 905 can remain empty or employed to
house a coil or a delivery device.
[0072] A variety of different profile-shaped longitudinal elements
can be formed through the principles described herein, as
exemplified by lead body 1000 depicted in FIGS. 13A-13B. Lead body
1000 can include longitudinal elements 1114, 1116, and 1118, (also
referred to as liners, tubular elements, etc.) one or more
insulated conductive elements 1004a, with lumen 1120 extending the
length of lead body 1000. Profile-shaped longitudinal element 1114
or cover, formed through the extrusion process previously
described, comprises a tubular body with a plurality of flared
protruding ends 1006 that extend seamlessly therefrom.
Profile-shaped longitudinal element 1114 can possess an diameter D1
that can range from about 0.04 inches to about 0.060 inches, D2
that can range from about 0.030 inches to about 0.050 inches, and
inner diameter, D3, can range from about 0.020 inches to about
0.040 inches.
[0073] Protruding ends 1006, formed as part of profile-shaped
longitudinal element 1114, serve to separate elongated insulated
conductive elements 112a-f from each other. Protruding ends 1006
extend from a proximal position 1008 to a distal position 1010 from
longitudinal element 1114. Protruding end 1006 can possess a height
that ranges from about 0.005 inches to about 0.015 inches. In one
embodiment, the flared protruding ends 1006 can possess a distal
end that can extend 2.alpha. between first and second sides 1012,
1014, respectively, which is about 90 degrees or less. In another
embodiment, the flared protruding ends 1006 can possess a distal
end that can extend 2.alpha. between first and second sides 1012,
1014, respectively, which is about 60 degrees or less. In still yet
another embodiment, the flared protruding ends 1006 can possess a
distal end that can extend 2.alpha. between first and second sides
1012, 1014, respectively, which is about 45 degrees or less. In
another embodiment, longitudinal element 1114 can include one or
more protruding ends 1106, depicted in FIG. 13C. Protruding ends
1106 can possess a distal end that can extend 2a between first and
second sides 1112, 1114, respectively, which is about 90 degrees or
less.
[0074] In this embodiment, the profiled-shaped cover is extruded
over either a mandrel or a conductive element 112a-f. In this
embodiment, the profiled-shaped cover is extruded over a mandrel.
Thereafter, insulated conductive elements 112a-f are served between
the recessed regions between each flared protruding ends 1006.
Thereafter two additional covers are formed over profiled-shaped
cover through, for example, extrusion, wrapping or other suitable
means.
[0075] The description of the invention is merely exemplary in
nature and, thus, variations that do not depart from the gist of
the invention are intended to be within the scope of the invention.
Such variations are not to be regarded as a departure from the
spirit and scope of the invention.
* * * * *