U.S. patent application number 15/232492 was filed with the patent office on 2016-12-01 for systems and methods for making and using connector assemblies for implantable medical device systems.
The applicant listed for this patent is Boston Scientific Neuromodulation Corporation. Invention is credited to James Robert Black.
Application Number | 20160346553 15/232492 |
Document ID | / |
Family ID | 53678075 |
Filed Date | 2016-12-01 |
United States Patent
Application |
20160346553 |
Kind Code |
A1 |
Black; James Robert |
December 1, 2016 |
SYSTEMS AND METHODS FOR MAKING AND USING CONNECTOR ASSEMBLIES FOR
IMPLANTABLE MEDICAL DEVICE SYSTEMS
Abstract
A lead extension for an electrical stimulation system includes a
lead-extension body, terminals, and a connector. The connector
includes a contact housing and a gasket housing. Multiple connector
contacts are disposed in the contact housing and are coupled to the
terminals. A retention member is disposed along one end of the
contact housing and is receivable by a retention socket defined in
the gasket housing. A deformable gasket is disposed in the
retention socket. A lumen extends through the connector and is
suitable for receiving an electrical stimulation lead. The received
lead is retained in the lumen by using the retention member to
compress the gasket along a longitudinal length of the connector.
The longitudinal compression of the gasket causes a corresponding
radial expansion of the gasket, which retains the electrical
stimulation lead within the lumen.
Inventors: |
Black; James Robert;
(Medina, OH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Boston Scientific Neuromodulation Corporation |
Valencia |
CA |
US |
|
|
Family ID: |
53678075 |
Appl. No.: |
15/232492 |
Filed: |
August 9, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14604299 |
Jan 23, 2015 |
9440066 |
|
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15232492 |
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61932074 |
Jan 27, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 1/3752 20130101;
A61N 1/0558 20130101; H01R 13/5224 20130101; H01R 2201/12 20130101;
A61N 1/0551 20130101; A61N 2001/0582 20130101; H01R 24/58
20130101 |
International
Class: |
A61N 1/375 20060101
A61N001/375; H01R 24/58 20060101 H01R024/58; H01R 13/52 20060101
H01R013/52; A61N 1/05 20060101 A61N001/05 |
Claims
1. A control module for an electrical stimulation system, the
control module comprising: an electronics housing; an electronic
subassembly disposed in the electronics housing; and a connector
coupled to the electronics housing, the connector configured and
arranged for receiving an electrical stimulation lead, the
connector comprising a contact housing having a first end portion,
an opposing second end portion, and an exterior surface, the
contact housing defining a contact-housing lumen and comprising a
plurality of connector contacts disposed in the contact housing and
exposed to the contact-housing lumen, the plurality of connector
contacts electrically coupled to the electronic subassembly, a
retention member disposed along the second end portion of the
contact housing, the retention member defining a retention-member
lumen extending along an entire length of the retention member, a
gasket housing coupled to the second end portion of the contact
housing, the gasket housing having a first end, an opposing second
end, and an exterior surface, a retention socket defined along the
first end of the gasket housing, the retention socket comprising a
rear wall and a side wall, the retention socket configured and
arranged for receiving the retention member, a gasket-housing lumen
extending between the exterior surface of the gasket housing and
the rear wall of the retention socket, and a deformable gasket
disposed in the retention socket and defining a gasket lumen,
wherein the retention-member lumen, the contact-housing lumen, the
gasket-housing lumen, and the gasket lumen collectively form a lead
lumen configured and arranged for receiving a portion of an
electrical stimulation lead, wherein the gasket housing is
configured and arranged to tighten toward the contact housing by
advancing the retention member into the retention socket and
compressing the deformable gasket along the longitudinal length of
the connector, the longitudinal compression of the gasket causing a
corresponding radial expansion of the gasket into the lead lumen,
the radial expansion of the gasket retaining a portion of the
electrical stimulation lead within the lead lumen when the
electrical stimulation lead is received by the lead lumen.
2. The control module of claim 1, wherein the side wall of the
retention socket comprises a threaded portion.
3. The control module of claim 2, wherein at least one thread is
disposed along an exterior surface of the retention member, the at
least one thread configured and arranged to mate with the threaded
portion of the side wall of the retention socket.
4. The control module of claim 1, wherein the gasket is configured
to form a watertight seal against the electrical stimulation lead
when the gasket is radially expanded toward a portion of the
electrical stimulation lead.
5. The control module of claim 1, wherein the gasket is disposed in
a pocket defined in the retention socket.
6. The control module of claim 1, wherein the connector further
comprises a biasing member disposed in the retention socket.
7. The control module of claim 1, wherein the retention member
comprises a protrusion extending from an exterior surface of the
retention member.
8. The control module of claim 7, wherein the side wall of the
retention socket defines a passageway configured and arranged for
receiving the protrusion.
9. The control module of claim 1, wherein the lead lumen is a first
lead lumen configured and arranged for receiving a portion of the
electrical stimulation lead, and wherein the connector defines a
second lead lumen configured and arranged for receiving a portion
of a second electrical stimulation lead.
10. A lead anchor for an implantable electrical stimulation system,
the lead anchor comprising: an anchor body having a longitudinal
length and an exterior surface, the anchor body comprising a
retention-member housing and a gasket housing, the retention-member
housing having a first end portion, an opposing second end portion,
and an exterior surface, the retention-member housing defining an
retention-member-housing lumen, the gasket housing coupled to the
second end portion of the retention-member housing, the gasket
housing having a first end, an opposing second end, and an exterior
surface; at least one anchoring unit disposed along the exterior
surface of the anchor body; a retention member disposed along the
second end portion of the retention-member housing, the retention
member defining a retention-member lumen extending along an entire
length of the retention member; a retention socket defined along
the first end of the gasket housing, the retention socket
configured and arranged for receiving the retention member, the
gasket housing comprising a rear wall and a side wall, a
gasket-housing lumen extending between the exterior surface of the
gasket housing and the rear wall of the retention socket, a
deformable gasket disposed in the gasket housing and defining a
gasket lumen; wherein the retention-member-housing lumen, the
retention-member lumen, the gasket-housing lumen, and the gasket
lumen collectively form a lead lumen configured and arranged for
receiving a portion of an electrical stimulation lead; wherein the
gasket housing is configured and arranged to tighten toward the
retention-member housing by advancing the retention member into the
retention socket and compressing the deformable gasket along the
longitudinal length of the anchor body, the longitudinal
compression of the gasket causing a corresponding radial expansion
of the gasket into the lead lumen, the radial expansion of the
gasket retaining a portion of the electrical stimulation lead
within the lead lumen when the electrical stimulation lead is
received by the lead lumen.
11. The lead anchor of claim 10, wherein the at least one anchoring
unit is disposed along the exterior surface of the retention-member
housing.
12. The lead anchor of claim 10, wherein the at least one anchoring
unit is disposed along the exterior surface of the gasket
housing.
13. The lead anchor of claim 10, wherein the side wall of the
retention socket comprises a threaded portion.
14. The lead anchor of claim 13, wherein at least one thread is
disposed along an exterior surface of the retention member, the at
least one thread configured and arranged to mate with the threaded
portion of the side wall of the retention socket.
15. The lead anchor of claim 10, wherein the gasket is configured
to form a watertight seal against the electrical stimulation lead
when the gasket is radially expanded toward a portion of the
electrical stimulation lead.
16. The lead anchor of claim 10, wherein the at least one anchoring
unit comprises an anchoring aperture defined in an anchor tab
extending outwardly from the anchor body.
17. The lead anchor of claim 10, wherein the gasket is disposed in
a pocket defined in the retention socket.
18. The lead anchor of claim 10, wherein the anchor body further
comprises a biasing member disposed in the retention socket.
19. The lead anchor of claim 10, wherein the retention member
comprises a protrusion extending from an exterior surface of the
retention member and the side wall of the retention socket defines
a passageway configured and arranged for receiving the
protrusion.
20. The lead anchor of claim 10, wherein the lead lumen is a first
lead lumen configured and arranged for receiving a portion of the
electrical stimulation lead, and wherein the anchor body defines a
second lead lumen configured and arranged for receiving a portion
of a second electrical stimulation lead.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of U.S. patent application
Ser. No. 14/604,299 filed Jan. 23, 2015 which claims the benefit
under 35 U.S.C. .sctn.119(e) of U.S. Provisional Patent Application
Ser. No. 61/932,074, filed Jan. 27, 2014, both of which are
incorporated herein by reference.
FIELD
[0002] The present invention is directed to the area of implantable
medical device systems and methods of making and using the systems.
The present invention is also directed to connector assemblies for
devices of the systems, as well as methods of making and using the
connector assemblies and implantable medical device systems.
BACKGROUND
[0003] Implantable medical device systems, such as electrical
stimulation systems, have proven therapeutic in a variety of
diseases and disorders. For example, spinal cord stimulation
systems have been used as a therapeutic modality for the treatment
of chronic pain syndromes. Peripheral nerve stimulation has been
used to treat chronic pain syndrome and incontinence, with a number
of other applications under investigation. Functional electrical
stimulation systems have been applied to restore some functionality
to paralyzed extremities in spinal cord injury patients.
[0004] Stimulators have been developed to provide therapy for a
variety of treatments. A stimulator can include a control module
(with a pulse generator), one or more leads, and an array of
stimulator electrodes on each lead. The stimulator electrodes are
in contact with or near the nerves, muscles, or other tissue to be
stimulated. The pulse generator in the control module generates
electrical pulses that are delivered by the electrodes to body
tissue.
[0005] Implantable electrical stimulation systems can also be used
for providing other types of stimulation including, for example,
deep brain stimulation. Deep brain stimulation can be useful for
treating, for example, Parkinson's disease, dystonia, essential
tremor, chronic pain, Huntington's disease, levodopa-induced
dyskinesias and rigidity, bradykinesia, epilepsy and seizures,
eating disorders, and mood disorders. Typically, a lead with a
stimulating electrode at or near a tip of the lead provides the
stimulation to target neurons in the brain. Magnetic resonance
imaging ("MRI") or computerized tomography ("CT") scans can provide
a starting point for determining where the stimulating electrode
should be positioned to provide the desired stimulus to the target
neurons.
[0006] After the lead is implanted into a patient's brain,
electrical stimulus current can be delivered through selected
electrodes on the lead to stimulate target neurons in the brain.
Typically, the electrodes are formed into rings disposed on a
distal portion of the lead. The stimulus current projects from the
ring electrodes equally in every direction. Because of the ring
shape of these electrodes, the stimulus current cannot be directed
to one or more specific positions around the ring electrode (e.g.,
on one or more sides, or points, around the lead). Consequently,
undirected stimulation may result in unwanted stimulation of
neighboring neural tissue, potentially resulting in undesired side
effects.
BRIEF SUMMARY
[0007] In one embodiment, a lead extension for an electrical
stimulation system includes a lead extension body having a distal
end portion and a proximal end portion, and a plurality of
terminals disposed along the proximal end portion of the lead
extension body. In addition, the electrical stimulation system
includes a connector disposed along the distal end portion of the
lead extension body. The connector has an exterior surface and a
longitudinal length. The connector includes a contact housing
having a first end portion, an opposing second end portion, and an
exterior surface. The contact housing defines a contact-housing
lumen and includes a plurality of connector contacts disposed in
the contact housing and exposed to the contact-housing lumen. In
addition, the connector includes a retention member disposed along
the second end portion of the contact housing. The retention member
defines a retention-member lumen extending along an entire length
of the retention member. Further, the connector includes a gasket
housing coupled to the second end portion of the contact housing.
The gasket housing has a first end, an opposing second end, and an
exterior surface. Furthermore, the connector includes a retention
socket defined along the first end of the gasket housing. The
retention socket includes a rear wall and a side wall. The
retention socket is configured and arranged for receiving the
retention member. A gasket-housing lumen extends between the
exterior surface of the gasket housing and the rear wall of the
retention socket. In addition, a deformable gasket is disposed in
the retention socket and defines a gasket lumen. The
retention-member lumen, the contact-housing lumen, the
gasket-housing lumen, and the gasket lumen are
longitudinally-aligned with one another along the longitudinal
length of the connector and collectively form a lead lumen
configured and arranged for receiving a portion of an electrical
stimulation lead. The gasket housing is configured and arranged to
tighten toward the contact housing by advancing the retention
member into the retention socket and compressing the deformable
gasket along the longitudinal length of the connector. The
longitudinal compression of the gasket causes a corresponding
radial expansion of the gasket into the lead lumen. The radial
expansion of the gasket retains a portion of an electrical
stimulation lead within the lead lumen when the electrical
stimulation lead is received by the lead lumen. Further, a
plurality of conductors electrically couples the plurality of
terminals to the plurality of connector contacts.
[0008] In another embodiment, a control module for an electrical
stimulation system includes an electronics housing, an electronic
subassembly disposed in the electronics housing, and a connector
coupled to the electronics housing. The connector is configured and
arranged for receiving an electrical stimulation lead. The
connector includes a contact housing having a first end portion, an
opposing second end portion, and an exterior surface. The contact
housing defines a contact-housing lumen and includes a plurality of
connector contacts disposed in the contact housing and exposed to
the contact-housing lumen. The plurality of connector contacts are
electrically coupled to the electronic subassembly. The contact
housing also includes a retention member disposed along the second
end portion of the contact housing. The retention member defines a
retention-member lumen extending along an entire length of the
retention member. The contact housing further includes a gasket
housing coupled to the second end portion of the contact housing.
The gasket housing has a first end, an opposing second end, and an
exterior surface. Furthermore, the contact housing includes a
retention socket defined along the first end of the gasket housing.
The retention socket includes a rear wall and a side wall. The
retention socket is configured and arranged for receiving the
retention member. The contact housing also includes a
gasket-housing lumen extending between the exterior surface of the
gasket housing and the rear wall of the retention socket, and a
deformable gasket disposed in the retention socket and defining a
gasket lumen. The retention-member lumen, the contact-housing
lumen, the gasket-housing lumen, and the gasket lumen are
longitudinally-aligned with one another along the longitudinal
length of the connector and collectively form a lead lumen
configured and arranged for receiving a portion of an electrical
stimulation lead. The gasket housing is configured and arranged to
tighten toward the contact housing by advancing the retention
member into the retention socket and compressing the deformable
gasket along the longitudinal length of the connector. The
longitudinal compression of the gasket causes a corresponding
radial expansion of the gasket into the lead lumen. The radial
expansion of the gasket retains a portion of an electrical
stimulation lead within the lead lumen when the electrical
stimulation lead is received by the lead lumen.
[0009] In yet another embodiment, a lead anchor for an implantable
electrical stimulation system includes an anchor body having a
longitudinal length and an exterior surface. The anchor body
includes a retention-member housing and a gasket housing. The
retention-member housing has a first end portion, an opposing
second end portion, and an exterior surface. The retention-member
housing defines a retention-member-housing lumen. The gasket
housing is coupled to the second end portion of the
retention-member housing. The gasket housing includes a first end,
an opposing second end, and an exterior surface. At least one
anchoring unit is disposed along the exterior surface of the anchor
body. A retention member is disposed along the second end portion
of the retention-member housing. The retention member defines a
retention-member lumen extending along an entire length of the
retention member. A retention socket is defined along the first end
of the gasket housing. The retention socket is configured and
arranged for receiving the retention member. The gasket housing
includes a rear wall and a side wall. A gasket-housing lumen
extends between the exterior surface of the gasket housing and the
rear wall of the retention socket. Additionally, a deformable
gasket is disposed in the gasket housing and defines a gasket
lumen. The retention-member-housing lumen, the retention-member
lumen, the gasket-housing lumen, and the gasket lumen are
longitudinally-aligned with one another along the longitudinal
length of the anchor body and collectively form a lead lumen
configured and arranged for receiving a portion of an electrical
stimulation lead. The gasket housing is configured and arranged to
tighten toward the retention-member housing by advancing the
retention member into the retention socket and compressing the
deformable gasket along the longitudinal length of the anchor body.
The longitudinal compression of the gasket causes a corresponding
radial expansion of the gasket into the lead lumen. The radial
expansion of the gasket retains a portion of an electrical
stimulation lead within the lead lumen when the electrical
stimulation lead is received by the lead lumen.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] Non-limiting and non-exhaustive embodiments of the present
invention are described with reference to the following drawings.
In the drawings, like reference numerals refer to like parts
throughout the various figures unless otherwise specified.
[0011] For a better understanding of the present invention,
reference will be made to the following Detailed Description, which
is to be read in association with the accompanying drawings,
wherein:
[0012] FIG. 1 is a schematic view of one embodiment of an
electrical stimulation system that includes a paddle lead
electrically coupled to a control module, according to the
invention;
[0013] FIG. 2 is a schematic view of one embodiment of an
electrical stimulation system that includes a percutaneous lead
electrically coupled to a control module, according to the
invention;
[0014] FIG. 3 is a schematic view of one embodiment of the control
module of FIG. 1 configured and arranged to electrically couple to
an elongated device, according to the invention;
[0015] FIG. 4 is a schematic view of one embodiment of a lead
extension configured and arranged to electrically couple the
elongated device of FIG. 2 to the control module of FIG. 1 via a
connector that includes a gasket housing coupled to a contact
housing, according to the invention;
[0016] FIG. 5 is a schematic side view of one embodiment of a
device for brain stimulation, according to the invention;
[0017] FIG. 6A is a perspective view of an embodiment of a portion
of a lead having a plurality of segmented electrodes, according to
the invention;
[0018] FIG. 6B is a perspective view of a second embodiment of a
portion of a lead having a plurality of segmented electrodes,
according to the invention;
[0019] FIG. 6C is a perspective view of a third embodiment of a
portion of a lead having a plurality of segmented electrodes,
according to the invention;
[0020] FIG. 6D is a perspective view of a fourth embodiment of a
portion of a lead having a plurality of segmented electrodes,
according to the invention;
[0021] FIG. 6E is a perspective view of a fifth embodiment of a
portion of a lead having a plurality of segmented electrodes,
according to the invention;
[0022] FIG. 7A is a schematic side view of one embodiment of the
contact housing of the connector of FIG. 4, the contact housing
including a retention member and a lead lumen extending through the
retention member and into the contact housing, according to the
invention;
[0023] FIG. 7B includes a schematic longitudinal cross-sectional
view of one embodiment of the gasket housing of the connector of
FIG. 4 and a gasket suitable for insertion into the gasket housing,
as well as schematic end views of the gasket housing and the
gasket, the gasket and gasket housing both defining lead lumens
extending therethrough, according to the invention;
[0024] FIG. 7C is a schematic longitudinal cross-sectional view of
one embodiment of the contact housing of FIG. 7A partially coupled
to the gasket housing of FIG. 7B via the retention member of the
contact housing and the retention socket of the gasket housing to
form the connector of FIG. 4, the contact housing and the gasket
housing collectively forming a lead lumen extending through the
gasket housing, the retention member, and at least a portion of the
contact housing, according to the invention;
[0025] FIG. 7D is a schematic end view of one embodiment of the
connector of FIG. 7C, according to the invention;
[0026] FIG. 8A is a schematic longitudinal cross-sectional view of
one embodiment of a lead body partially inserted into the lead
lumen of the connector of FIG. 7C, according to the invention;
[0027] FIG. 8B is a schematic longitudinal cross-sectional view of
one embodiment of the lead body of FIG. 8A fully inserted into the
lead lumen of the connector of FIG. 7C, according to the
invention;
[0028] FIG. 8C is a schematic longitudinal cross-sectional view of
one embodiment of the lead body of FIG. 8A fully inserted into the
lead lumen of the connector of FIG. 7C and with the contact housing
tightened toward the gasket housing such that the retention member
compresses the gasket along a length of the connector, the
compression of the gasket causing the gasket to expand radially
into the lead lumen, thereby compressing toward a portion of the
lead body disposed within the lumen, according to the
invention;
[0029] FIG. 8D is a schematic longitudinal cross-sectional view of
one embodiment of the lead body of FIG. 8A fully inserted into the
lead lumen of the connector of FIG. 7C and with the contact housing
tightened toward the gasket housing such that the retention member
squeezes the gasket along a length of the connector, the
compression of the gasket causing the gasket to expand radially
into the lead lumen, thereby compressing against a retention sleeve
disposed along the lead body, according to the invention;
[0030] FIG. 8E is a schematic end view of one embodiment of the
connector housing and gasket housing of FIG. 8C or 8D without the
lead body of FIG. 8A inserted into the lead lumen of the connector
housing and the gasket housing, the gasket expanding radially into
the lumen as the retention member is longitudinally compressed,
according to the invention;
[0031] FIG. 9 is a schematic side view of one embodiment of the
connector of FIG. 7C and a lead body suitable for insertion into a
lead lumen of the connector, the connector including anchoring
units disposed along exterior surfaces of the connector, according
to the invention;
[0032] FIG. 10 is a schematic side view of one embodiment of a
connector housing suitable for receiving multiple lead bodies,
according to the invention;
[0033] FIG. 11 is a schematic side view of one embodiment of a
connector suitable for receiving a lead body, the connector
disposed on a control module, according to the invention;
[0034] FIG. 12 is a schematic side view of one embodiment of a lead
body inserted into a lead anchor, the lead anchor including a
retention member that is disposed along a retention-member housing
and that couples with a gasket disposed in a retention socket of a
gasket housing, according to the invention;
[0035] FIG. 13A is a schematic longitudinal cross-sectional view of
another embodiment of a retention member suitable for inserting
into a retention socket of a gasket housing, the gasket housing
including a gasket and a biasing member disposed in the retention
socket, according to the invention;
[0036] FIG. 13B is a schematic longitudinal cross-sectional view of
one embodiment of the lead body of FIG. 13A inserted into retention
member and gasket housing of FIG. 13A with the gasket of the gasket
housing tightened around a portion of the lead body to retain the
lead body within a lead lumen extending through the retention
member and gasket housing, according to the invention;
[0037] FIG. 14A is a schematic side view of one embodiment of the
retention member and the gasket housing of FIG. 13A, the gasket
housing defining a passageway along a side wall of the retention
socket of the gasket housing, the passageway suitable for receiving
a protrusion disposed along the retention member, according to the
invention;
[0038] FIG. 14B is a schematic side view of one embodiment of the
retention member and the gasket housing of FIG. 14A, with the
protrusion of the retention member received by the passageway of
the gasket housing, according to the invention; and
[0039] FIG. 15 is a schematic overview of one embodiment of
components of a stimulation system, including an electronic
subassembly disposed within a control module, according to the
invention.
DETAILED DESCRIPTION
[0040] The present invention is directed to the area of implantable
medical device systems and methods of making and using the systems.
The present invention is also directed to connector assemblies for
devices of the systems, as well as methods of making and using the
connector assemblies and implantable medical device systems.
[0041] Suitable implantable electrical stimulation systems include,
but are not limited to, a lead with one or more electrodes disposed
along a distal end of the lead and one or more terminals disposed
along the one or more proximal ends of the lead. Leads include, for
example, percutaneous leads, paddle leads, and cuff leads. Examples
of electrical stimulation systems with leads are found in, for
example, U.S. Pat. Nos. 6,181,969; 6,516,227; 6,609,029; 6,609,032;
6,741,892; 7,949,395; 7,244,150; 7,672,734; 7,761,165; 7,974,706;
8,175,710; 8,224,450; and 8,364,278; and U.S. Patent Application
Publication No. 2007/0150036, all of which are incorporated by
reference.
[0042] FIG. 1 illustrates schematically one embodiment of an
electrical stimulation system 100. The electrical stimulation
system includes a control module (e.g., a stimulator or pulse
generator) 102 and a lead 103 coupleable to the control module 102.
The lead 103 includes a paddle body 104 and one or more lead bodies
106. In FIG. 1, the lead 103 is shown having two lead bodies 106.
It will be understood that the lead 103 can include any suitable
number of lead bodies including, for example, one, two, three,
four, five, six, seven, eight, or more lead bodies 106. An array
133 of electrodes, such as electrode 134, is disposed on the paddle
body 104, and an array of terminals (e.g., 310 in FIG. 3) is
disposed along each of the one or more lead bodies 106.
[0043] It will be understood that the electrical stimulation system
can include more, fewer, or different components and can have a
variety of different configurations including those configurations
disclosed in the electrical stimulation system references cited
herein. For example, instead of a paddle body, the electrodes can
be disposed in an array at or near the distal end of a lead body
forming a percutaneous lead.
[0044] FIG. 2 illustrates schematically another embodiment of the
electrical stimulation system 100, where the lead 103 is a
percutaneous lead. In FIG. 2, the electrodes 134 are shown disposed
along the one or more lead bodies 106. In at least some
embodiments, the lead 103 is isodiametric along a longitudinal
length of the lead body 106.
[0045] The lead 103 can be coupled to the control module 102 in any
suitable manner. In FIG. 1, the lead 103 is shown coupling directly
to the control module 102. In at least some other embodiments, the
lead 103 couples to the control module 102 via one or more
intermediate devices. For example, in at least some embodiments one
or more lead extensions (402 in FIG. 4 and in other figures) can be
disposed between the lead 103 and the control module 102 to extend
the distance between the lead 103 and the control module 102. Other
intermediate devices may be used in addition to, or in lieu of, one
or more lead extensions including, for example, a splitter, an
adaptor, or the like or combinations thereof. It will be understood
that, in the case where the electrical stimulation system 100
includes multiple elongated devices disposed between the lead 103
and the control module 102, the intermediate devices may be
configured into any suitable arrangement.
[0046] In FIG. 2, the electrical stimulation system 100 is shown
having a splitter 107 suitable for facilitating coupling of the
lead 103 to the control module 102. The splitter 107 includes a
splitter connector 108 for coupling to a proximal end of the lead
103, and one or more splitter tails 109a and 109b for coupling to
the control module 102 (or another splitter, a lead extension, an
adaptor, or the like).
[0047] With reference to FIGS. 1 and 2, the control module 102
typically includes a connector housing 112 and a sealed electronics
housing 114. An electronic subassembly 110 and an optional power
source 120 are disposed in the electronics housing 114. A control
module connector 144 is disposed in the connector housing 112. The
control module connector 144 is configured and arranged to make an
electrical connection between the lead 103 and the electronic
subassembly 110 of the control module 102.
[0048] The electrical stimulation system or components of the
electrical stimulation system, including the paddle body 104, the
one or more of the lead bodies 106, and the control module 102, are
typically implanted into the body of a patient. The electrical
stimulation system can be used for a variety of applications
including, but not limited to deep brain stimulation, neural
stimulation, spinal cord stimulation, muscle stimulation, and the
like.
[0049] The electrodes 134 can be formed using any conductive,
biocompatible material. Examples of suitable materials include
metals, alloys, conductive polymers, conductive carbon, and the
like, as well as combinations thereof. In at least some
embodiments, one or more of the electrodes 134 are formed from one
or more of: platinum, platinum iridium, palladium, palladium
rhodium, or titanium.
[0050] Any suitable number of electrodes 134 can be disposed on the
lead including, for example, four, five, six, seven, eight, nine,
ten, eleven, twelve, fourteen, sixteen, twenty-four, thirty-two, or
more electrodes 134. In the case of paddle leads, the electrodes
134 can be disposed on the paddle body 104 in any suitable
arrangement. In FIG. 1, the electrodes 134 are arranged into two
columns, where each column has eight electrodes 134.
[0051] The electrodes of the paddle body 104 (or one or more lead
bodies 106) are typically disposed in, or separated by, a
non-conductive, biocompatible material such as, for example,
silicone, polyurethane, polyetheretherketone ("PEEK"), epoxy, and
the like or combinations thereof. The one or more lead bodies 106
and, if applicable, the paddle body 104 may be formed in the
desired shape by any process including, for example, molding
(including injection molding), casting, and the like. The
non-conductive material typically extends from the distal ends of
the one or more lead bodies 106 to the proximal end of each of the
one or more lead bodies 106.
[0052] In the case of paddle leads, the non-conductive material
typically extends from the paddle body 104 to the proximal end of
each of the one or more lead bodies 106. Additionally, the
non-conductive, biocompatible material of the paddle body 104 and
the one or more lead bodies 106 may be the same or different.
Moreover, the paddle body 104 and the one or more lead bodies 106
may be a unitary structure or can be formed as two separate
structures that are permanently, or detachably, coupled
together.
[0053] Terminals (e.g., 310 in FIG. 3) are typically disposed along
the proximal end of the one or more lead bodies 106 of the
electrical stimulation system 100 (as well as any splitters, lead
extensions, adaptors, or the like) for electrical connection to
corresponding connector contacts (e.g., 314 in FIG. 3). The
connector contacts are disposed in connectors (e.g., 144 in FIGS.
1-4; 420 in FIGS. 4, 7D-8D, and 9; 1020 in FIG. 10; and 1120 in
FIG. 11) which, in turn, are disposed on, for example, the control
module 102 (or a lead extension, a splitter, an adaptor, or the
like). Electrically conductive wires, cables, or the like (not
shown) extend from the terminals to the electrodes 134. Typically,
one or more electrodes 134 are electrically coupled to each
terminal. In at least some embodiments, each terminal is only
connected to one electrode 134.
[0054] The electrically conductive wires ("conductors") may be
embedded in the non-conductive material of the lead body 106 or can
be disposed in one or more lumens (not shown) extending along the
lead body 106. In some embodiments, there is an individual lumen
for each conductor. In other embodiments, two or more conductors
extend through a lumen. There may also be one or more lumens (not
shown) that open at, or near, the proximal end of the one or more
lead bodies 106, for example, for inserting a stylet to facilitate
placement of the one or more lead bodies 106 within a body of a
patient. Additionally, there may be one or more lumens (not shown)
that open at, or near, the distal end of the one or more lead
bodies 106, for example, for infusion of drugs or medication into
the site of implantation of the one or more lead bodies 106. In at
least one embodiment, the one or more lumens are flushed
continually, or on a regular basis, with saline, epidural fluid, or
the like. In at least some embodiments, the one or more lumens are
permanently or removably sealable at the distal end.
[0055] FIG. 3 illustrates one embodiment of a proximal end of one
or more elongated devices 300 configured and arranged for coupling
to one embodiment of the control module connector 144. The one or
more elongated devices may include, for example, one or more of the
lead bodies (106 in FIG. 1), one or more intermediate devices
(e.g., a splitter, the lead extension (402 in FIG. 4), an adaptor,
or the like or combinations thereof), or a combination thereof.
[0056] The control module connector 144 defines at least one port
into which a proximal end of the elongated device 300 can be
inserted, as shown by directional arrows 312a and 312b. In FIG. 3
(and in other figures), the connector housing 112 is shown having
two ports 304a and 304b. The connector housing 112 can define any
suitable number of ports including, for example, one, two, three,
four, five, six, seven, eight, or more ports.
[0057] The control module connector 144 also includes a plurality
of connector contacts, such as connector contact 314, disposed
within each port 304a and 304b. When the elongated device 300 is
inserted into the ports 304a and 304b, the connector contacts 314
can be aligned with a plurality of terminals 310 disposed along the
proximal end(s) of the elongated device(s) 300 to electrically
couple the control module 102 to the electrodes (134 in FIG. 1)
disposed on the paddle body 104 of the lead 103. Examples of
connectors in control modules are found in, for example, U.S. Pat.
Nos. 7,244,150 and 8,224,450, which are incorporated by
reference.
[0058] In at least some embodiments, the elongated device 300
(e.g., one of the lead bodies 106 of FIGS. 1 and 2, the splitter
207, an adaptor, another lead extension, or the like or
combinations thereof) is coupled to the control module 102 via a
lead extension. FIG. 4 illustrates one embodiment of a lead
extension 402 coupled to the control module 102 via a port 404
defined in the control module connector 144. The lead extension 402
is suitable for receiving one or more elongated devices 300. In
FIG. 4, the lead extension 402 is shown being suitable for
receiving a single elongated device 300.
[0059] The lead extension 402 has a body 406 with a proximal end
portion 408 and a distal end portion 410. As will be discussed in
more detail below (see e.g., FIGS. 7A-14B), a connector 420 is
disposed along the distal end portion 410 of the lead extension
402. The connector 420 includes a contact housing 430 coupleable to
a gasket housing 440. A plurality of connector contacts, such as
connector contact 424, is disposed in the contact housing 430. The
connector contacts 424 are suitable for coupling with terminals,
such as terminal 310, of the elongated device 300 when the proximal
end portion of the elongated device 300 is inserted into the
connector 420. The gasket housing 440 facilitates retention of the
elongated device 300 when the elongated device 300 is received by
the connector 420.
[0060] In at least some embodiments, the proximal end portion 408
of the lead extension 402 is similarly configured and arranged as a
proximal end portion of the lead 103 (or other elongated device
300). The lead extension 402 may include a plurality of
electrically conductive wires (not shown) that electrically couple
the connector contacts 424 to the proximal end portion 408 of the
lead extension 402.
[0061] In at least some embodiments, the conductive wires disposed
in the lead extension 402 can be electrically coupled to a
plurality of terminals (not shown) disposed along the proximal end
portion 408 of the lead extension 402. In at least some
embodiments, the proximal end portion 408 of the lead extension 402
is configured and arranged for insertion into a connector disposed
in another lead extension (or another intermediate device). In
other embodiments (and as shown in FIG. 4), the proximal end
portion 408 of the lead extension 402 is configured and arranged
for insertion into the control module connector 144.
[0062] Turning to FIGS. 5-6E, in some embodiments leads (e.g.,
percutaneous leads) are used in electrical stimulation systems
designed for brain stimulation. FIG. 5 illustrates one embodiment
of a device 500 for brain stimulation. The device includes a lead
510, a plurality of electrodes 525 disposed at least partially
about a circumference of the lead 510, a plurality of terminals
535, a connector 532 for connection of the electrodes to a control
unit, and a stylet 540 for assisting in insertion and positioning
of the lead in the patient's brain. The stylet 540 can be made of a
rigid material. Examples of suitable materials for the stylet
include, but are not limited to, tungsten, stainless steel, and
plastic. The stylet 540 may have a handle 550 to assist insertion
into the lead 510, as well as rotation of the stylet 540 and lead
510. The connector 532 fits over a proximal end of the lead 510,
preferably after removal of the stylet 540.
[0063] The control unit (not shown) is typically an implantable
pulse generator that can be implanted into a patient's body, for
example, below the patient's clavicle area. The pulse generator can
have, for example, eight stimulation channels that may be
independently programmable to control the magnitude of the current
stimulus from each channel. In some cases, the pulse generator can
have more or fewer than eight stimulation channels (e.g., 4-, 6-,
16-, 32-, or more stimulation channels). The control unit can have
one, two, three, four, or more connector ports, for receiving the
plurality of terminals 535 at the proximal end of the lead 510.
[0064] In one example of operation, access to the desired position
in the brain can be accomplished by drilling a hole in the
patient's skull or cranium with a cranial drill (commonly referred
to as a burr), and coagulating and incising the dura mater, or
brain covering. The lead 510 can be inserted into the cranium and
brain tissue with the assistance of the stylet 540. The lead 510
can be guided to the target location within the brain using, for
example, a stereotactic frame and a microdrive motor system. In
some embodiments, the microdrive motor system is fully or partially
automatic. The microdrive motor system may be configured to perform
one or more the following actions (alone or in combination): insert
the lead 510, retract the lead 510, or rotate the lead 510.
[0065] In some embodiments, measurement devices coupled to the
muscles or other tissues stimulated by the target neurons, or a
unit responsive to the patient or clinician, can be coupled to the
control unit or microdrive motor system. The measurement device,
user, or clinician can indicate a response by the target muscles or
other tissues to the stimulation or recording electrode(s) to
further identify the target neurons and facilitate positioning of
the stimulation electrode(s). For example, if the target neurons
are directed to a muscle experiencing tremors, a measurement device
can be used to observe the muscle and indicate changes in tremor
frequency or amplitude in response to stimulation of neurons.
Alternatively, the patient or clinician can observe the muscle and
provide feedback.
[0066] The lead 510 for deep brain stimulation can include
stimulation electrodes, recording electrodes, or both. In at least
some embodiments, the lead 510 is rotatable so that the stimulation
electrodes can be aligned with the target neurons after the neurons
have been located using the recording electrodes.
[0067] Stimulation electrodes may be disposed on the circumference
of the lead 510 to stimulate the target neurons. Stimulation
electrodes may be ring-shaped so that current projects from each
electrode equally in every direction from the position of the
electrode along a length of the lead 510. Ring electrodes typically
do not enable stimulus current to be directed from only a limited
angular range around of the lead. Segmented electrodes, however,
can be used to direct stimulus current to a selected angular range
around the lead. When segmented electrodes are used in conjunction
with an implantable pulse generator that delivers constant current
stimulus, current steering can be achieved to more precisely
deliver the stimulus to a position around an axis of the lead
(i.e., radial positioning around the axis of the lead).
[0068] To achieve current steering, segmented electrodes can be
utilized in addition to, or as an alternative to, ring electrodes.
Though the following description discusses stimulation electrodes,
it will be understood that all configurations of the stimulation
electrodes discussed may be utilized in arranging recording
electrodes as well.
[0069] The lead 500 includes a lead body 510, one or more optional
ring electrodes 520, and a plurality of sets of segmented
electrodes 530. The lead body 510 can be formed of a biocompatible,
non-conducting material such as, for example, a polymeric material.
Suitable polymeric materials include, but are not limited to,
silicone, polyurethane, polyurea, polyurethane-urea, polyethylene,
or the like. Once implanted in the body, the lead 500 may be in
contact with body tissue for extended periods of time. In at least
some embodiments, the lead 500 has a cross-sectional diameter of no
more than 1.5 mm and may be in the range of 0.5 to 1.5 mm. In at
least some embodiments, the lead 500 has a length of at least 10 cm
and the length of the lead 500 may be in the range of 10 to 70
cm.
[0070] The electrodes can be made using a metal, alloy, conductive
oxide, or any other suitable conductive biocompatible material.
Examples of suitable materials include, but are not limited to,
platinum, platinum iridium alloy, iridium, titanium, tungsten,
palladium, palladium rhodium, or the like. Preferably, the
electrodes are made of a material that is biocompatible and does
not substantially corrode under expected operating conditions in
the operating environment for the expected duration of use.
[0071] Each of the electrodes can either be used or unused (OFF).
When the electrode is used, the electrode can be used as an anode
or cathode and carry anodic or cathodic current. In some instances,
an electrode might be an anode for a period of time and a cathode
for a period of time.
[0072] Stimulation electrodes in the form of ring electrodes 520
can be disposed on any part of the lead body 510, usually along a
distal end portion of the lead 500. In FIG. 5, the lead 500
includes two ring electrodes 520. Any number of ring electrodes 520
can be disposed along the length of the lead body 510 including,
for example, one, two three, four, five, six, seven, eight, nine,
ten, eleven, twelve, thirteen, fourteen, fifteen, sixteen, or more
ring electrodes 520. It will be understood that any number of ring
electrodes can be disposed along the length of the lead body 510.
In some embodiments, the ring electrodes 520 are substantially
cylindrical and wrap around the entire circumference of the lead
body 510. In some embodiments, the outer diameters of the ring
electrodes 520 are substantially equal to the outer diameter of the
lead body 510. The length of the ring electrodes 520 may vary
according to the desired treatment and the location of the target
neurons. In some embodiments the length of the ring electrodes 520
are less than or equal to the diameters of the ring electrodes 520.
In other embodiments, the lengths of the ring electrodes 520 are
greater than the diameters of the ring electrodes 520. As discussed
in more detail below, the distal-most ring electrode 520 may be a
tip electrode (see e.g., tip electrode 620a of FIG. 6E) which
covers most, or all, of the distal tip of the lead.
[0073] Deep brain stimulation leads may include one or more sets of
segmented electrodes. Segmented electrodes may provide for superior
current steering than ring electrodes because target structures in
deep brain stimulation are not typically symmetric about the axis
of the distal electrode array. Instead, a target may be located on
one side of a plane running through the axis of the lead. Through
the use of a radially segmented electrode array ("RSEA"), current
steering can be performed not only along a length of the lead but
also around a circumference of the lead. This provides precise
three-dimensional targeting and delivery of the current stimulus to
neural target tissue, while potentially avoiding stimulation of
other tissue. Examples of leads with segmented electrodes include
U.S. Patent Application Publication Nos. 2010/0268298;
2011/0005069; 2011/0130803; 2011/0130816; 2011/0130817;
2011/0130818; 2011/0078900; 2011/0238129; 2012/0016378;
2012/0046710; 2012/0071949; 2012/0165911; 2012/197375;
2012/0203316; 2012/0203320; 2012/0203321, all of which are
incorporated herein by reference.
[0074] The lead 500 is shown having a plurality of segmented
electrodes 530. Any number of segmented electrodes 530 may be
disposed on the lead body 510 including, for example, one, two
three, four, five, six, seven, eight, nine, ten, eleven, twelve,
thirteen, fourteen, fifteen, sixteen, or more segmented electrodes
530. It will be understood that any number of segmented electrodes
530 may be disposed along the length of the lead body 510. A
segmented electrode 530 typically extends only 75%, 67%, 60%, 50%,
40%, 33%, 25%, 20%, 17%, 15%, or less around the circumference of
the lead.
[0075] The segmented electrodes 530 may be grouped into sets of
segmented electrodes, where each set is disposed around a
circumference of the lead 500 at a particular longitudinal portion
of the lead 500. The lead 500 may have any number segmented
electrodes 530 in a given set of segmented electrodes. The lead 500
may have one, two, three, four, five, six, seven, eight, or more
segmented electrodes 530 in a given set. In at least some
embodiments, each set of segmented electrodes 530 of the lead 500
contains the same number of segmented electrodes 530. The segmented
electrodes 530 disposed on the lead 500 may include a different
number of electrodes than at least one other set of segmented
electrodes 530 disposed on the lead 500.
[0076] The segmented electrodes 530 may vary in size and shape. In
some embodiments, the segmented electrodes 530 are all of the same
size, shape, diameter, width, or area or any combination thereof.
In some embodiments, the segmented electrodes 530 of each
circumferential set (or even all segmented electrodes disposed on
the lead 500) may be identical in size and shape.
[0077] Each set of segmented electrodes 530 may be disposed around
the circumference of the lead body 510 to form a substantially
cylindrical shape around the lead body 510. The spacing between
individual electrodes of a given set of the segmented electrodes
may be the same, or different from, the spacing between individual
electrodes of another set of segmented electrodes on the lead 500.
In at least some embodiments, equal spaces, gaps, or cutouts are
disposed between each segmented electrode 530 around the
circumference of the lead body 510. In other embodiments, the
spaces, gaps, or cutouts between the segmented electrodes 530 may
differ in size or shape. In other embodiments, the spaces, gaps, or
cutouts between segmented electrodes 530 may be uniform for a
particular set of the segmented electrodes 530, or for all sets of
the segmented electrodes 530. The sets of segmented electrodes 530
may be positioned in irregular or regular intervals along a length
the lead body 510.
[0078] Conductor wires that attach to the ring electrodes 520 or
segmented electrodes 530 extend along the lead body 510. These
conductor wires may extend through the material of the lead 500 or
along one or more lumens defined by the lead 500, or both. The
conductor wires are presented at a connector (via terminals) for
coupling of the electrodes 520, 530 to a control unit (not
shown).
[0079] When the lead 500 includes both ring electrodes 520 and
segmented electrodes 530, the ring electrodes 520 and the segmented
electrodes 530 may be arranged in any suitable configuration. For
example, when the lead 500 includes two sets of ring electrodes 520
and two sets of segmented electrodes 530, the ring electrodes 520
can flank the two sets of segmented electrodes 530 (see e.g., FIG.
5). Alternately, the two sets of ring electrodes 520 can be
disposed proximal to the two sets of segmented electrodes 530 (see
e.g., FIG. 6C), or the two sets of ring electrodes 520 can be
disposed distal to the two sets of segmented electrodes 530 (see
e.g., FIG. 6D). One of the ring electrodes can be a tip electrode
(see, tip electrode 620a of FIG. 6E). It will be understood that
other configurations are possible as well (e.g., alternating ring
and segmented electrodes, or the like).
[0080] By varying the location of the segmented electrodes 530,
different coverage of the target neurons may be selected. For
example, the electrode arrangement of FIG. 6C may be useful if the
physician anticipates that the neural target will be closer to a
distal tip of the lead body 510, while the electrode arrangement of
FIG. 6D may be useful if the physician anticipates that the neural
target will be closer to a proximal end of the lead body 510.
[0081] Any combination of ring electrodes 520 and segmented
electrodes 530 may be disposed on the lead 500. For example, the
lead may include a first ring electrode 520, two sets of segmented
electrodes; each set formed of four segmented electrodes 530, and a
final ring electrode 520 at the end of the lead. This configuration
may simply be referred to as a 1-4-4-1 configuration (FIGS. 6A and
6E). It may be useful to refer to the electrodes with this
shorthand notation. Thus, the embodiment of FIG. 6C may be referred
to as a 1-1-4-4 configuration, while the embodiment of FIG. 6D may
be referred to as a 4-4-1-1 configuration. Other electrode
configurations include, for example, a 2-2-2-2 configuration, where
four sets of segmented electrodes are disposed on the lead, and a
4-4 configuration, where two sets of segmented electrodes, each
having four segmented electrodes 530 are disposed on the lead.
Another electrode configuration is a 1-3-3-1 configuration with two
sets of segmented electrodes, each set containing three electrodes
disposed around the circumference of the lead, flanked by two ring
electrodes or a ring electrode and a tip electrode. In some
embodiments, the lead includes 16 electrodes. Possible
configurations for a 16-electrode lead include, but are not limited
to 4-4-4-4; 8-8; 3-3-3-3-3-1 (and all rearrangements of this
configuration); and 2-2-2-2-2-2-2-2.
[0082] In some embodiments, measurement devices coupled to the
muscles or other tissues stimulated by the target neurons or a unit
responsive to the patient or clinician can be coupled to the
control unit or microdrive motor system. The measurement device,
user, or clinician can indicate a response by the target muscles or
other tissues to the stimulation or recording electrodes to further
identify the target neurons and facilitate positioning of the
stimulation electrodes. For example, if the target neurons are
directed to a muscle experiencing tremors, a measurement device can
be used to observe the muscle and indicate changes in tremor
frequency or amplitude in response to stimulation of neurons.
Alternatively, the patient or clinician may observe the muscle and
provide feedback.
[0083] The reliability and durability of the lead will depend
heavily on the design and method of manufacture. Fabrication
techniques discussed below provide methods that can produce
manufacturable and reliable leads.
[0084] When the lead 500 includes a plurality of sets of segmented
electrodes 530, it may be desirable to form the lead 500 such that
corresponding electrodes of different sets of segmented electrodes
530 are longitudinally aligned with one another along the length of
the lead 500 (see e.g., the segmented electrodes 530 shown in FIG.
5). Longitudinal alignment between corresponding electrodes of
different sets of segmented electrodes 530 along the length of the
lead 500 may reduce uncertainty as to the location or orientation
between corresponding segmented electrodes of different sets of
segmented electrodes. Accordingly, it may be beneficial to form
electrode arrays such that corresponding electrodes of different
sets of segmented electrodes along the length of the lead 500 are
longitudinally aligned with one another and do not
circumferentially shift in relation to one another during
manufacturing of the lead 500.
[0085] In other embodiments, individual electrodes in the two sets
of segmented electrodes 530 are staggered (see, FIG. 6B) relative
to one another along the length of the lead body 510. In some
cases, the staggered positioning of corresponding electrodes of
different sets of segmented electrodes along the length of the lead
500 may be designed for a specific application.
[0086] FIGS. 6A-6E illustrate leads 600 with segmented electrodes
630, optional ring electrodes 620 or tip electrodes 620a, and a
lead body 610. The sets of segmented electrodes 630 include either
two (FIG. 6B) or four (FIGS. 6A, 6C, and 6D) or any other number of
segmented electrodes including, for example, three, five, six, or
more.
[0087] Any other suitable arrangements of segmented electrodes can
be used. As an example, arrangements in which segmented electrodes
are arranged helically with respect to each other. One embodiment
includes a double helix.
[0088] As mentioned above (FIG. 6E), a tip electrode can be used in
combination with one or more circumferential electrodes (e.g., one
or more ring electrodes, one or more segmented electrodes, or any
combination of one or more ring electrodes and one or more
segmented electrodes). In at least some embodiments, a tip
electrode may be selected to have the same, or substantially the
same, surface area as one or more ring electrodes of the lead.
[0089] Turning to FIGS. 7A-14B, at least some connectors include
retention assemblies for retaining a portion of a lead or lead
extension in the connector. Retention assemblies may enlarge the
circumference of the connector. For example, at least some known
retention assemblies may include a threaded aperture that extends
along a plane that is transverse to a longitudinal length of the
connector and that receives a fastener that presses against a
received lead or lead extension. Enlarging the circumference of the
connector may be undesirable because it may be uncomfortable to the
patient and may limit the locations where the connector can be
implanted. Additionally, at least some known retention assemblies
are formed from stainless steel and are covered by a septum to
prevent fluid ingress into the connector. In which case, current
leakage may occur if the septum is damaged.
[0090] As herein described, an improved connector (see e.g., 420 of
FIG. 4) includes a retention assembly that includes a deformable
gasket that retains a device (such as a lead or lead extension)
within the connector by longitudinally compressing the gasket. The
longitudinal compression of the gasket causes a corresponding
radial expansion of the gasket towards the device within the
connector. In at least some embodiments, the radial expansion of
the gasket retains the device within the connector. In at least
some embodiments, the radial expansion forms a watertight seal
between the connector and the retained device. In a least some
embodiments, the connector has a smaller circumference than a
conventional connector having a retention assembly that includes a
transverse threaded aperture.
[0091] The connector can be disposed along any suitable implantable
medical device including, for example, a lead extension, a control
module, a lead anchor, or the like. In some embodiments, the
disclosed connector can be used for coupling an electrical
stimulation lead to a lead extension. For example, the connector
420, shown in FIG. 4, is suitable for connecting the elongate
device 300 to the lead extension body 406.
[0092] FIGS. 7A-7D illustrate one embodiment of the connector 420
disposed along a distal end portion of the lead extension 402. FIG.
7A illustrates, in side view, one embodiment of the contact housing
430 of the connector 420. The contact housing 430 is an elongate
member having a first end portion 706, an opposing second end
portion 708, and an exterior surface 732. The contact housing 430
defines a contact-housing lumen 792a suitable for receiving a
portion of an elongated device, such as a lead or a lead extension,
within the contact housing 430.
[0093] In some embodiments, the contact housing 430 is a tubular
structure having an outer diameter larger than the outer diameter
of the lead extension body 406. In some other embodiments, the
contact housing 430 is isodiametric with the lead extension body
406. The contact housing 430 and the lead extension body 406 may be
a unitary structure or can be formed as two separate structures
that are permanently, or detachably, coupled together.
[0094] The contact housing 430 has a length and an inner diameter
suitable for receiving a portion of an elongated device, such as
the elongated device 300, in the contact-housing lumen 792a.
Connector contacts 424 are exposed to contact-housing lumen 792a.
In at least some embodiments, the connector contacts 424 are
suitable for electrically coupling to terminals disposed along an
elongated device when the elongated device is received by the
contact-housing lumen 792a.
[0095] A retention member 710 is disposed along the second end
portion 708 of the contact housing 430. The retention member 710
defines a retention-member lumen 792b extending along the entire
length of the retention member 710. The retention-member lumen 792b
opens to, and is aligned with, the contact-housing lumen 792a. The
contact housing 430 can form a unitary structure with the retention
member 710, or can be formed as two separate structures that are
permanently, or detachably, coupled to one another.
[0096] In some embodiments, the retention member 710 is a tubular
structure extending outwardly from the second end portion 708 in a
direction that is parallel to the longitudinal length of the
contact housing 430. In at least some embodiments, the retention
member 710 has an outer diameter that is smaller than an outer
diameter of the contact housing 430. In some embodiments, a thread
712 is disposed along an exterior surface of the retention member
710.
[0097] FIG. 7B illustrates, in longitudinal cross-sectional view,
one embodiment of the gasket housing 440 suitable for coupling with
the contact housing 430. In at least some embodiments, the gasket
housing 440 is an elongate member having a first end portion 736
and an opposing second end portion 738. The gasket housing 440 has
an exterior surface 742 and a gasket-housing lumen 792c extending
between the first end portion 736 and the second end portion 738.
The contact housing 430 and the gasket housing 440 can be either
permanently coupled to one another or completely separable from one
another. In at least some embodiments, the gasket housing 440 and
the contact housing 430 are isodiametric with one another.
[0098] The gasket housing 440 includes a retention socket 744
defined along the first end portion 736 of the gasket housing 440.
The retention socket 744 is suitable for receiving the retention
member 710. The retention socket 744 includes a rear wall 746 and a
side wall 748. In at least some embodiments, the rear wall 746 is
disposed along the second end portion 738 of the gasket housing
440. In some embodiments, the side wall 748 includes a threaded
portion 750 having a thread suitable to mate with the thread 712 of
the retention member 710. In at least some embodiments, the
gasket-housing lumen 792c extends through the rear wall 746 of the
retention socket 744.
[0099] A gasket 760 is disposed in the gasket housing 440. In at
least some embodiments, the gasket 760 is disposed in the retention
socket 744. In some embodiments, the gasket 760 is disposed in a
pocket 752 defined in the retention socket 744 along the rear wall
746. The gasket 760 can be of any suitable shape to dispose within
the gasket housing 440. The gasket 760 defines a gasket lumen 792d
extending through the length of the gasket 760. In FIG. 7B, the
gasket 760 is shown as being torus-shaped. The gasket 760 is
deformable and can change shape under compression and can regain
its original shape when such compression is released.
[0100] The gasket 760 has a length suitable for expanding radially
when compressed longitudinally. In addition, the material of the
gasket 760 may be chosen such that longitudinal compression of the
gasket 760 causes radial expansion of the gasket 760. Some example
of such materials includes flexible polymers, rubber, silicone, or
the like or their combinations thereof. In some embodiments, the
material of the gasket 760 is chosen to form a watertight seal when
tightened against an outer surface of a received elongated
device.
[0101] FIG. 7C illustrates, in longitudinal cross-sectional view,
one embodiment of the contact housing 430 partially coupled to the
gasket housing 440 to form the connector 420. FIG. 7D illustrates,
in end view, one embodiment of the connector 420. The contact
housing 430 and the gasket housing 440 are partially coupled to one
another by inserting the retention member 710 into the retention
socket 744. The partial coupling of the gasket housing 440 and the
contact housing 430 aligns the contact-housing lumen 792a, the
retention-member lumen 792b, the gasket-housing lumen 792c, and the
gasket lumen 792d along the longitudinal length of the connector
420 to collectively form a lead lumen 792. The lead lumen 792 is
suitable for receiving an elongated device, such as an electrical
stimulation lead, a lead extension, a splitter, an adaptor, or the
like.
[0102] The contact housing 430 can tighten against the gasket
housing 440 by advancing the gasket housing 440 along the retention
member 710 in a direction shown by directional arrow 754. In FIG.
7C (and in other figures), the contact housing 430 advances against
the gasket housing 440 via the threads 712 of the retention member
710 and the threaded portion 750 of the side wall 748 of the
retention socket 744. In at least some embodiments, the retention
member 710 can be advanced within the retention socket 744 by
rotating the gasket housing 440 relative to the retention member
710, like a nut over a screw. It will be understood that other
mating techniques are contemplated including, for example, the
mechanism described with reference to FIGS. 13A-14B.
[0103] When the retention member 710 advances far enough into the
retention socket 744, the retention member 710 contacts, and then
compresses, a portion of the gasket 760 along the longitudinal
length of the connector 420 between a distal tip of the retention
member 710 and the rear wall 746 of the retention socket 744. In at
least some embodiments, the contact housing 430, the retention
member 710, and the gasket housing 440 are made of materials that
are harder than the gasket 760 such that the gasket 760 compresses
when the retention member 710 and the gasket housing 440 are
tightened against each other.
[0104] Turning to FIGS. 8A-8E, the compression of the gasket 760
along the longitudinal length of the connector 420 causes a
corresponding radial expansion of the gasket 760 into the lumen
792. In at least some embodiments, the radial expansion of the
gasket 760 constricts the portion of the lead lumen 792 extending
along the gasket (the gasket lumen 792d). When an elongated device
is received by the lead lumen 792, the radial expansion of the lead
lumen 792 may retain the received elongated device. In at least
some embodiments, radial expansion of the gasket 760 causes a
watertight seal to be formed with the received elongated
device.
[0105] FIG. 8A illustrates, in longitudinal cross-sectional view,
one embodiment of a proximal end portion 812 of a body 806 of a
lead partially inserted into the lead lumen 792 of the connector
420. The lead includes a plurality of terminals 810 disposed along
the proximal end portion 812 of the lead. The gasket housing 440 is
partially coupled to the contact housing 430 such that the
retention member 710 is not in contact with the gasket 760.
[0106] FIG. 8B depicts the lead fully inserted into the lead lumen
792 of the connector 420 with the terminals 810 of the lead aligned
with the connector contacts 424 in the contact housing 430, thereby
coupling the terminals 810 to the connector contacts 424. In at
least some embodiments, the coupling of the connector contacts 424
to the terminals 810 enables transmission of electrical signals
from an electronic subassembly coupled to the connector contacts
424 to electrodes coupled to the terminals 810.
[0107] FIG. 8C depicts the gasket housing 440 tightened against the
contact housing 430. The retention member 710 compresses the gasket
760 in the retention socket 744 along the longitudinal length of
the connector 420. The longitudinal compression of the gasket 760
causes the gasket 760 to expand radially into the lead lumen 792.
In FIG. 8C, the radial expansion of the gasket 760 causes the
gasket 760 to press against a portion of the lead disposed within
the lead lumen 792. The radially-expanded gasket 760 grips and
retains the lead within the connector 420. In some embodiments, a
watertight seal is formed between the lead and the connector
420.
[0108] In at least some embodiments, as shown in FIG. 8D, a
retention sleeve 814 is disposed along the proximal end portion of
the lead 806. The retention sleeve 814 is a structure (for example,
a band) that is either disposed over or within a portion of the
lead. The retention sleeve 814 can be made of any suitable rigid
material with such as stainless steel, polyvinyl chloride (PVC) or
the like. The retention sleeve 814 provides a lead surface along
which the gasket 760 can be compressed without compressing the lead
body 806. In some embodiments, the retention sleeve 814 has a rough
outer surface to increase friction at the location where the
retention sleeve 814 mates with the gasket 760. The increased
friction between the retention sleeve 814 and the gasket 760 can
further improve the retention of the lead in the connector 420.
[0109] FIG. 8E illustrates, in transverse cross-sectional view, one
embodiment of the contact housing 430 tightened against the gasket
housing 440 without the lead inserted into the lead lumen 792. As
shown in FIG. 8E, the gasket 760 is expanded radially into the lead
lumen 792 and narrows the lead lumen 792 along the portion 792c of
the lead lumen extending through the gasket 760.
[0110] Turning to FIG. 9, in at least some embodiments the
connector is suitable for anchoring to patient tissue. Anchoring
the connector to patient tissue may reduce, or even prevent,
undesired movement of the connector relative to the patient
subsequent to an implantation procedure. Any suitable type of
anchoring mechanisms may be used including, for example, suture
sleeve, clips, or the like or combinations thereof.
[0111] FIG. 9 illustrates, in side view, one embodiment of the
connector 420 and a proximal end portion of the body 906 of a lead
suitable for insertion into a lead lumen 792 of the connector 420.
The connector 420 includes anchoring units 970 disposed along the
exterior surface 732 of the connector 420. The anchoring units 970
can be disposed along the contact housing 430, or the gasket
housing 440, or both.
[0112] In some embodiments, the anchoring units 970 include
anchoring tabs 972 extending outwardly from the exterior surface of
the connector 420. Each anchoring tab 972 includes at least one
anchoring aperture 974 that can be used to anchor (e.g., suture,
staple, or the like or combinations thereof) the connector 420 to
patient tissue. It will be understood that the connector 420 can
include any suitable number of anchoring units 970 including, for
example, one, two, three, four, five, six, seven, eight, or more
anchoring units 970. The anchoring units 970 may be a formed as a
part of the connector 420. Alternately, the anchoring units 970 may
be formed along another component, such as a sleeve, that can be
disposed over the connector 420.
[0113] Turning to FIG. 10, in some embodiments a connector may be
suitable for receiving multiple electrical stimulation lead bodies.
The multiple lead bodies can be from the same lead or from
different leads. FIG. 10 illustrates, in side view, one embodiment
of a connector 1020 suitable for receiving portions of two bodies
1006a and 1006b of one or more leads. In at least some embodiments,
the connector 1020 includes a contact housing 1030 formed by
attaching two contact housings 1030a and 1030b as a unitary
structure or as two separate structures that are permanently, or
detachably, coupled together. In FIG. 10, the contact housings
1030a and 1030b are shown in a side-by-side configuration. Other
configurations are contemplated. In FIG. 10, two contact housings
are shown. In at least some embodiments, the connector 1020
includes more than two contact housings.
[0114] The connector housings 1030a and 1030b define lead lumens
1092a and 1092b, respectively, and two pluralities of connector
contacts: first connector contacts 1024a, and second connector
contacts 1024b, open to the lead lumens 1092a and 1092b,
respectively. In some embodiments, the connector contacts 1024a and
1024b each include eight connector contacts.
[0115] A gasket housing 1040a couples with connector housing 1030a
via a retention member 1010a. A deformable gasket 1060a is disposed
in the gasket housing 1040a. The lead lumen 1092a, which is
suitable for receiving and retaining the lead body 1006a, extends
through each of: the gasket housing 1040a, the retention member
1010a, and the contact housing 1030a.
[0116] Similarly, a gasket housing 1040b couples with connector
housing 1030b via a retention member 1010b. A deformable gasket
1060b is disposed in the gasket housing 1040b. The lead lumen
1092b, which is suitable for receiving and retaining the lead body
1006b, extends through each of: the gasket housing 1040b, the
retention member 1010b, and the contact housing 1030b.
[0117] Optionally, the connector 1020 includes one or more
anchoring units 1070 suitable for anchoring the connector 1020 to
patient tissue. The one or more anchoring units 1070 can be
disposed along the contact housing 103, or the gasket housing
1040a, or the gasket housing 1040b, or some combination
thereof.
[0118] Turning to FIG. 11, in at least some embodiments the
connector is disposed along a control module. FIG. 11 illustrates,
in side view, one embodiment of a control module connector 1120
suitable for receiving a proximal end portion of a body 1106 of a
lead. The connector 1120 is disposed along an outer surface of a
control module 1102. In at least some embodiments, the
non-connector portions of the control module 1102 are similar in
structure and function as the control module 102 (shown in FIG. 1
and other figures). The connector 1120 is similar in structure and
function to connector 420 (shown in FIG. 4 and other figures), and
includes a lumen 1192 extending through a connector housing 1130
with connector contacts, a gasket housing 1140, a deformable gasket
1160, and a retention member 1110.
[0119] Turning to FIG. 12, in at least some embodiments the
connector can be used with an implantable medical device that does
not include connector contacts for making an electrical connection
with a received elongated member, such as a lead anchor. FIG. 12
illustrates, in side view, one embodiment of a portion of a body
1206 of a lead retained by a lead anchor 1202. The lead anchor 1202
includes a retention member 1210 disposed along a retention member
housing 1230, a gasket 1260 disposed in a gasket housing 1240, and
a lead lumen that is suitable for receiving the lead body 1206 and
that extends entirely through each of: the retention member 1210,
the retention member housing 1230, the gasket 1260, and the gasket
housing 1240. In at least some embodiments, the gasket housing 1240
is suitable for tightening against the retention member housing
1230 and longitudinally compressing the gasket 1260, as described
above, with reference to FIGS. 7A-8E.
[0120] The lead anchor 1202 includes one or more anchoring units,
such as anchoring unit 1270 (similar to the anchoring units 970
shown in FIG. 9), disposed along the external surface of the lead
anchor 1202. The one or more anchoring units 1270 are suitable for
anchoring the lead anchor 1202 to patient tissue.
[0121] In some embodiments, to anchor the lead body 1206 to patient
tissue, the lead body 1206 is extended through the lead anchor
1202. The lead anchor 1202 is positioned at a desired location
along the lead body 1206 and the gasket housing 1240 is tightened
against the retention member housing 1230 to retain the lead body
1206 within the lead anchor 1202. The lead anchor 1202 can be
sutured or stapled to patient tissue using the anchoring units 1270
either before or after the lead body is retained in the lead anchor
1202.
[0122] Turning to FIGS. 13A-14B, a number of different mechanisms
can be used for mating a housing, such as the contact housing or
the retention member housing, to the gasket housing. In FIG. 7C,
the retention member 710 and the retention socket 744 are shown
having threads that mate with each other. As shown in FIG. 7C, the
gasket housing 440 is rotatable along the retention member 710,
like a nut over a screw, to couple the contact housing 430 and the
gasket housing 440.
[0123] Alternately, in some embodiments a retention mechanism
includes one or more biasing members, a passageway, and a
protrusion. The passageway and the protrusion may form a mechanism
for advancing the gasket housing relative to the retention member.
The biasing member may bias the retention member along the
longitudinal length of the connector to releasably lock the gasket
housing in a tightened position with the retention member.
[0124] FIG. 13A illustrates, in longitudinal cross-sectional view,
one embodiment of a retention member 1310 suitable for inserting
into a retention socket 1344 of a gasket housing 1340. The
retention member can be attached to a housing (not shown), such as
a connector housing, or a retention member housing, or the like.
The gasket housing 1340 includes a gasket 1360 and a biasing member
1376 disposed in the retention socket 1344. The biasing member 1376
is disposed in the retention socket 1344 adjacent to the gasket
1360. In at least some embodiments, the biasing member 1376 is
disposed concentrically outwards from the gasket 1360.
[0125] The retention member 1310 can be advanced towards the gasket
1360 in the retention socket 1344 to mate the retention member 1310
with the gasket housing 1340 and retain a portion of the lead body
1306 within the gasket housing 1340. FIG. 13B shows the gasket
housing 1340 in a tightened position against the retention member
1310 such that a portion the lead body 1306 is retained by the
gasket 1360 within the gasket housing 1330. The retention member
1310 is shown longitudinally compressing the gasket 1360. As the
retention member 1310 is advanced towards the gasket 1360, the
biasing member 1376 biases the retention member 1310 along the
longitudinal axis of the gasket housing 1340 in a direction shown
by directional arrow 1377. As shown in FIG. 13B, advancement of the
retention member 1310 into the retention socket 1344 is performed
against the biasing force of the biasing member 1376. The biasing
member 1376 can include a spring, elastic band, flexible arms, or
the like that pushes the retention member 1310 away from the gasket
1360.
[0126] FIGS. 14A-14B illustrates a locking mechanism that can be
used to lock the retention member 1310 in the tightened position
against the gasket housing 1340. FIG. 14A illustrates, in side
view, one embodiment of the retention member 1310 and the gasket
housing 1340 in a partially coupled configuration (i.e., the
retention member is not physically touching the gasket), such as is
depicted in FIG. 13A. FIG. 14B illustrates, in side view, one
embodiment of the retention member 1310 and the gasket housing 1340
in a tightened position (i.e., the retention member is compressing
the gasket), such as is depicted in FIG. 13B.
[0127] The gasket housing 1340 defines a passageway 1482 formed
along a side wall of the retention socket 1344 of the gasket
housing 1340. The passageway 1482 is suitable for receiving a
protrusion 1480 disposed along an outer surface of the retention
member 1310. To move the retention member 1310 into the retention
socket 1344, a user can move the gasket housing 1340 toward the
retention member 1310 while slightly rotating the gasket housing
1340 as the protrusion 1480 moves along the passageway 1482.
[0128] The biasing member 1376 biases the retention member 1310
along the longitudinal axis in a direction that maintains the
position of the protrusion 1480 at a terminus 1484 of the
passageway 1482 (as shown in FIG. 14B). When the protrusion 1480 is
positioned at the terminus 1484 of the passageway 1482, the gasket
housing 1340 is tightened against the retention member 1310 and an
inserted lead body, such as the lead body 1306, is retained within
the gasket housing 1340, as shown in FIG. 13B.
[0129] In at least some embodiments, moving the gasket housing 1340
inward (against the biasing force of the biasing member 1376) while
rotating the gasket housing 1340 removes the protrusion 1480 from
the terminus 1484 of the passageway 1482, enabling the protrusion
1480 to follow the passageway 1482 away from the terminus, thereby
uncoupling the gasket housing 1340 from the retention member 1310
(as shown in FIG. 13A) and enabling the inserted lead body to be
released from the gasket housing. It will be understood that,
alternately, the protrusion can be disposed along the gasket
housing and the passageway can be formed along the retention
member.
[0130] FIG. 15 is a schematic overview of one embodiment of
components of an electrical stimulation system 1500 including an
electronic subassembly 1510 disposed within a control module. It
will be understood that the electrical stimulation system can
include more, fewer, or different components and can have a variety
of different configurations including those configurations
disclosed in the stimulator references cited herein.
[0131] Some of the components (for example, a power source 1512, an
antenna 1518, a receiver 1502, and a processor 1504) of the
electrical stimulation system can be positioned on one or more
circuit boards or similar carriers within a sealed housing of an
implantable pulse generator, if desired. Any power source 1512 can
be used including, for example, a battery such as a primary battery
or a rechargeable battery. Examples of other power sources include
super capacitors, nuclear or atomic batteries, mechanical
resonators, infrared collectors, thermally-powered energy sources,
flexural powered energy sources, bioenergy power sources, fuel
cells, bioelectric cells, osmotic pressure pumps, and the like
including the power sources described in U.S. Pat. No. 7,437,193,
incorporated herein by reference.
[0132] As another alternative, power can be supplied by an external
power source through inductive coupling via the optional antenna
1518 or a secondary antenna. The external power source can be in a
device that is mounted on the skin of the user or in a unit that is
provided near the user on a permanent or periodic basis.
[0133] If the power source 1512 is a rechargeable battery, the
battery may be recharged using the optional antenna 1518, if
desired. Power can be provided to the battery for recharging by
inductively coupling the battery through the antenna 1518 to a
recharging unit 1516 external to the user. Examples of such
arrangements can be found in the references identified above.
[0134] In one embodiment, electrical current is emitted by the
electrodes 134 on the paddle or lead body to stimulate nerve
fibers, muscle fibers, or other body tissues near the electrical
stimulation system. The processor 1504 is generally included to
control the timing and electrical characteristics of the electrical
stimulation system. For example, the processor 1504 can, if
desired, control one or more of the timing, frequency, strength,
duration, and waveform of the pulses. In addition, the processor
1504 can select which electrodes can be used to provide
stimulation, if desired. In some embodiments, the processor 1504
selects which electrode(s) are cathodes and which electrode(s) are
anodes. In some embodiments, the processor 1504 is used to identify
which electrodes provide the most useful stimulation of the desired
tissue.
[0135] Any processor can be used and can be as simple as an
electronic device that, for example, produces pulses at a regular
interval or the processor can be capable of receiving and
interpreting instructions from an external programming unit 1508
that, for example, allows modification of pulse characteristics. In
the illustrated embodiment, the processor 1504 is coupled to a
receiver 1502 which, in turn, is coupled to the optional antenna
1518. This allows the processor 1504 to receive instructions from
an external source to, for example, direct the pulse
characteristics and the selection of electrodes, if desired.
[0136] In one embodiment, the antenna 1518 is capable of receiving
signals (e.g., RF signals) from an external telemetry unit 1506
which is programmed by the programming unit 1508. The programming
unit 1508 can be external to, or part of, the telemetry unit 1506.
The telemetry unit 1506 can be a device that is worn on the skin of
the user or can be carried by the user and can have a form similar
to a pager, cellular phone, or remote control, if desired. As
another alternative, the telemetry unit 1506 may not be worn or
carried by the user but may only be available at a home station or
at a clinician's office. The programming unit 1508 can be any unit
that can provide information to the telemetry unit 1506 for
transmission to the electrical stimulation system 1500. The
programming unit 1508 can be part of the telemetry unit 1506 or can
provide signals or information to the telemetry unit 1506 via a
wireless or wired connection. One example of a suitable programming
unit is a computer operated by the user or clinician to send
signals to the telemetry unit 1506.
[0137] The signals sent to the processor 1504 via the antenna 1518
and the receiver 1502 can be used to modify or otherwise direct the
operation of the electrical stimulation system. For example, the
signals may be used to modify the pulses of the electrical
stimulation system such as modifying one or more of pulse duration,
pulse frequency, pulse waveform, and pulse strength. The signals
may also direct the electrical stimulation system 1500 to cease
operation, to start operation, to start charging the battery, or to
stop charging the battery. In other embodiments, the stimulation
system does not include the antenna 1518 or receiver 1502 and the
processor 1504 operates as programmed.
[0138] Optionally, the electrical stimulation system 1500 may
include a transmitter (not shown) coupled to the processor 1504 and
the antenna 1518 for transmitting signals back to the telemetry
unit 1506 or another unit capable of receiving the signals. For
example, the electrical stimulation system 1500 may transmit
signals indicating whether the electrical stimulation system 1500
is operating properly or not or indicating when the battery needs
to be charged or the level of charge remaining in the battery. The
processor 1504 may also be capable of transmitting information
about the pulse characteristics so that a user or clinician can
determine or verify the characteristics.
[0139] The above specification, examples and data provide a
description of the manufacture and use of the composition of the
invention. Since many embodiments of the invention can be made
without departing from the spirit and scope of the invention, the
invention also resides in the claims hereinafter appended.
* * * * *