U.S. patent number RE48,907 [Application Number 17/004,577] was granted by the patent office on 2022-02-01 for systems and methods for making and using improved leads for electrical stimulation systems.
This patent grant is currently assigned to Boston Scientific Neuromodulation Corporation. The grantee listed for this patent is Boston Scientific Neuromodulation Corporation. Invention is credited to Andrew DiGiore, Thomas Lopez.
United States Patent |
RE48,907 |
DiGiore , et al. |
February 1, 2022 |
Systems and methods for making and using improved leads for
electrical stimulation systems
Abstract
A method for manufacturing a lead includes forming an elongated
multi-lumen conductor guide defining a central stylet lumen and a
plurality of conductor lumens arranged around the stylet lumen. The
multi-lumen conductor guide is twisted to form at least one helical
section where the plurality of conductor lumens each forms a
helical pathway around the stylet lumen. Each of the helical
pathways of the at least one helical section has a pitch that is no
less than 0.04 turns per centimeter.
Inventors: |
DiGiore; Andrew (San Francisco,
CA), Lopez; Thomas (Sunland, CA) |
Applicant: |
Name |
City |
State |
Country |
Type |
Boston Scientific Neuromodulation Corporation |
Valencia |
CA |
US |
|
|
Assignee: |
Boston Scientific Neuromodulation
Corporation (Valencia, CA)
|
Family
ID: |
1000005926740 |
Appl.
No.: |
17/004,577 |
Filed: |
August 27, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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16165477 |
Oct 19, 2018 |
RE48235 |
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13490310 |
Jan 27, 2015 |
8942810 |
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61494247 |
Jun 7, 2011 |
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Reissue of: |
14605781 |
Jan 26, 2015 |
9474895 |
Oct 25, 2016 |
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Reissue of: |
14605781 |
Jan 26, 2015 |
9474895 |
Oct 25, 2016 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N
1/0534 (20130101); Y10T 29/49117 (20150115); H01B
13/0016 (20130101) |
Current International
Class: |
A61N
1/05 (20060101); A61N 1/08 (20060101); H01B
13/00 (20060101) |
Field of
Search: |
;607/115,116,122 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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2010055421 |
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May 2010 |
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WO |
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2010055453 |
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May 2010 |
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WO |
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Other References
The International Search Report dated Aug. 16, 2012 in
corresponding International Application No. PCT/US2012/041133.
cited by applicant .
Official Communication for U.S. Appl. No. 13/490,310 dated Apr. 4,
2014. cited by applicant .
Official Communication for U.S. Appl. No. 14/605,781 dated Sep. 21,
2015. cited by applicant .
Official Communication for U.S. Appl. No. 14/605,781 dated Feb. 25,
2016. cited by applicant .
Official Communication for U.S. Appl. No. 16/165,477 dated May 16,
2019. cited by applicant .
Official Communication for U.S. Appl. No. 16/165,477 dated Oct. 3,
2019. cited by applicant .
Official Communication for U.S. Appl. No. 16/165,477 dated Jan. 17,
2020. cited by applicant .
The International Search Report issued on Aug. 16, 2012 in
corresponding International Application No. PCT/US2012/041133.
cited by applicant.
|
Primary Examiner: Flanagan; Beverly M
Attorney, Agent or Firm: Branch Partners PLLC Black; Bruce
E.
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation of U.S. patent application Ser.
No. 13/490,310 filed Jun. 6, 2012 and issued as U.S. Pat. No.
8,942,810 on Jan. 27, 2015, which claims the benefit under 35
U.S.C. .sctn. 119(e) of U.S. Provisional Patent Application Ser.
No. 61/494,247 filed on Jun. 7, 2011, both of which are
incorporated herein by reference.
Claims
What is claimed as new and desired to be protected by Letters
Patent of the United States is:
.[.1. A lead for providing deep brain stimulation the lead
comprising: a lead body having a distal end, a proximal end, and a
longitudinal length, the lead body comprising a multi-lumen
conductor guide having an outer surface and defining a central
stylet lumen configured and arranged for receiving a stylet and a
plurality of conductor lumens disposed around the central stylet
lumen in a ring, each conductor lumen configured and arranged to
receive at least one conductor, wherein the plurality of conductor
lumens are completely inset from the outer surface of the
multi-lumen conductor guide, wherein at least a portion of the
multi-lumen conductor guide is twisted such that the multi-lumen
conductor guide forms at least a first helical section and a second
helical section where each of the plurality of conductor lumens
forms a helical pathway around the stylet lumen, wherein each of
the helical pathways of the first and second helical sections has a
pitch that is no less than 0.04 turns per centimeter, wherein the
multi-lumen conductor guide further forms a first straight section
disposed between the first helical section and the second helical
section; a plurality of electrodes disposed on the distal end of
the lead body; a plurality of lead terminals disposed on the
proximal end of the lead body; and a plurality of conductors
electrically coupling the plurality of electrodes to the plurality
of lead terminals, wherein the plurality of conductors extend along
the longitudinal length of the leady body within the plurality of
conductor lumens, wherein the multi-lumen conductor guide extends
the entire longitudinal length of the lead body from the electrodes
to the terminals..].
.[.2. The lead of claim 1, wherein each of the plurality of
conductor lumens is configured and arranged to receive a different
single conductor of the plurality of conductors..].
.[.3. The lead of claim 1, wherein each of the plurality of
conductor lumens is configured and arranged to receive a plurality
of conductors of the plurality of conductors..].
.[.4. The lead of claim 1, wherein the first helical section and
the second helical section are twisted in opposite directions from
one another along the longitudinal length of the lead body..].
.[.5. The lead of claim 1, wherein the first helical section has a
constant pitch..].
.[.6. The lead of claim 1, wherein the first helical section has a
variable pitch..].
.[.7. An electrical stimulation system comprising: the lead of
claim 1; and a control unit coupleable to lead, the control unit
configured and arranged for providing stimulation to the plurality
of electrodes of the lead..].
.[.8. A method for manufacturing the lead of claim 1, the method
comprising: forming the multi-lumen conductor guide defining the
central stylet lumen and the plurality of conductor lumens arranged
around the stylet lumen; and twisting the multi-lumen conductor
guide to form the first helical section wherein the first helical
section has the pitch that is no less than 0.04 turns per
centimeter..].
.[.9. The method of claim 8, further comprising applying heat to
the multi-lumen conductor guide to set the first helical
section..].
.[.10. The method of claim 9, further comprising inserting at least
one of the plurality of conductors into at least one of the
plurality of conductor lumens..].
.[.11. The method of claim 10, further comprising inserting at
least one mandrel into each of the plurality of conductor lumens
prior to applying heat to the multi-lumen conductor guide..].
.[.12. The method of claim 11, further comprising removing the at
least one mandrel from each of the plurality of conductor lumens
prior to inserting the at least one conductor into each of the
plurality of conductor lumens..].
.[.13. The method of claim 8, wherein twisting the multi-lumen
conductor guide comprises twisting the multi-lumen conductor guide
to form helical pathways each having a pitch that is no greater
than 0.8 turns per centimeter..].
.[.14. The method of claim 8, wherein forming an elongated
multi-lumen conductor guide comprising extruding the multi-lumen
conductor guide and wherein twisting the multi-lumen conductor
guide comprises twisting the multi-lumen conductor guide while
extruding the multi-lumen conductor guide..].
.[.15. A lead for providing deep brain stimulation, the lead
comprising: a lead body having a distal end, a proximal end, and a
longitudinal length, the lead body comprising a multi-lumen
conductor guide having an outer surface and defining a central
stylet lumen configured and arranged for receiving a stylet and a
plurality of conductor lumens disposed around the central stylet
lumen in a ring, each conductor lumen configured and arranged to
receive at least one conductor, wherein the plurality of conductor
lumens are completely inset from the outer surface of the
multi-lumen conductor guide, wherein at least a portion of the
multi-lumen conductor guide is twisted such that the multi-lumen
conductor guide forms at least a first helical section and a second
helical section where each of the plurality of conductor lumens
forms a helical pathway around the stylet lumen, wherein each of
the helical pathways of the first and second helical sections has a
pitch that is no less than 0.04 turns per centimeter, wherein the
first and second helical sections are axially separate from each
other and the first helical section and the second helical section
are twisted in opposite directions from one another along the
longitudinal length of the lead body; a plurality of electrodes
disposed on the distal end of the lead body; a plurality of lead
terminals disposed on the proximal end of the lead body; and a
plurality of conductors electrically coupling the plurality of
electrodes to the plurality of lead terminals, wherein the
plurality of conductors extend along the longitudinal length of the
leady body within the plurality of conductor lumens, wherein the
multi-lumen conductor guide extends the entire longitudinal length
of the lead body from the electrodes to the terminals..].
.[.16. The lead of claim 15, wherein each of the plurality of
conductor lumens is configured and arranged to receive a different
single conductor of the plurality of conductors..].
.[.17. The lead of claim 15, wherein each of the plurality of
conductor lumens is configured and arranged to receive a plurality
of conductors of the plurality of conductors..].
.[.18. The lead of claim 15, wherein the first helical section has
a constant pitch..].
.[.19. The lead of claim 15, wherein the first helical section has
a variable pitch..].
.[.20. An electrical stimulation system comprising: the lead of
claim 15; and a control unit coupleable to lead, the control unit
configured and arranged for providing stimulation to the plurality
of electrodes of the lead..].
.Iadd.21. A lead, comprising: a lead body having a distal end, a
proximal end, and a longitudinal length, the lead body comprising a
multi-lumen conductor guide having an outer surface and defining a
central stylet lumen and a plurality of conductor lumens extending
along the multi-lumen conductor guide and disposed around the
central stylet lumen in a ring, each conductor lumen configured and
arranged to receive at least one conductor, wherein the plurality
of conductor lumens are completely inset from the outer surface of
the multi-lumen conductor guide, wherein at least a portion of the
multi-lumen conductor guide is twisted such that the multi-lumen
conductor guide forms at least one helical section where each of
the plurality of conductor lumens forms a helical pathway along the
at least one helical section of the multi-lumen conductor guide,
wherein each of the helical pathways of the at least one helical
section has a pitch that is no less than 0.04 turns per centimeter,
the lead body further comprising at least one outer coating of
material disposed over the outer surface of the multi-lumen
conductor guide; a plurality of electrodes disposed on the distal
end of the lead body; a plurality of lead terminals disposed on the
proximal end of the lead body; and a plurality of conductors
electrically coupling the plurality of electrodes to the plurality
of lead terminals, wherein the plurality of conductors extend along
the longitudinal length of the lead body within the plurality of
conductor lumens, wherein the multi-lumen conductor guide extends
the entire longitudinal length of the lead body from the electrodes
to the terminals..Iaddend.
.Iadd.22. The lead of claim 21, wherein the multi-lumen conductor
guide further forms at least one straight section adjacent at least
one of the at least one helical section..Iaddend.
.Iadd.23. The lead of claim 21, wherein at least one of the at
least one helical section has a pitch that is no more than 0.8
turns per centimeter..Iaddend.
.Iadd.24. The lead of claim 21, wherein each of the at least one
helical section has a pitch that is no more than 0.8 turns per
centimeter..Iaddend.
.Iadd.25. An electrical stimulation system comprising: the lead of
claim 21; and a control unit coupleable to lead, the control unit
configured and arranged for providing stimulation to the plurality
of electrodes of the lead..Iaddend.
.Iadd.26. A method for manufacturing the lead of claim 21, the
method comprising: forming the multi-lumen conductor guide defining
the plurality of conductor lumens; and twisting the multi-lumen
conductor guide to form the at least one helical
section..Iaddend.
.Iadd.27. The method of claim 26, further comprising applying heat
to the multi-lumen conductor guide to set the at least one helical
section..Iaddend.
.Iadd.28. The method of claim 26, wherein twisting the multi-lumen
conductor guide comprises twisting the multi-lumen conductor guide
to form helical pathways each having a pitch that is no more than
0.8 turns per centimeter..Iaddend.
.Iadd.29. The method of claim 26, wherein forming an elongated
multi-lumen conductor guide comprising extruding the multi-lumen
conductor guide and wherein twisting the multi-lumen conductor
guide comprises twisting the multi-lumen conductor guide while
extruding the multi-lumen conductor guide..Iaddend.
.Iadd.30. A lead, comprising: a lead body having a distal end, a
proximal end, and a longitudinal length, the lead body comprising a
multi-lumen conductor guide having an outer surface and defining a
central stylet lumen and a plurality of conductor lumens extending
along the multi-lumen conductor guide and disposed around the
central stylet lumen in a ring, each conductor lumen configured and
arranged to receive at least one conductor, wherein the plurality
of conductor lumens are completely inset from the outer surface of
the multi-lumen conductor guide, wherein at least a portion of the
multi-lumen conductor guide is twisted such that the multi-lumen
conductor guide comprises a first straight section, a helical
section where each of the plurality of conductor lumens forms a
helical pathway along the helical section of the multi-lumen
conductor guide, and a second straight section, wherein the helical
section is disposed between the first straight section and the
second straight section and has a pitch that is no less than 0.04
turns per centimeter; a plurality of electrodes disposed on the
distal end of the lead body; a plurality of lead terminals disposed
on the proximal end of the lead body; and a plurality of conductors
electrically coupling the plurality of electrodes to the plurality
of lead terminals, wherein the plurality of conductors extend along
the longitudinal length of the lead body within the plurality of
conductor lumens, wherein the multi-lumen conductor guide extends
at least from the electrodes to the terminals..Iaddend.
.Iadd.31. The lead of claim 30, wherein the helical section has a
pitch that is no more than 0.8 turns per centimeter..Iaddend.
.Iadd.32. The lead of claim 30, wherein the helical section has a
constant pitch..Iaddend.
.Iadd.33. The lead of claim 30, wherein the helical section has a
variable pitch..Iaddend.
.Iadd.34. The lead of claim 30, wherein each of the plurality of
conductor lumens is configured and arranged to receive a different
single conductor of the plurality of conductors..Iaddend.
.Iadd.35. The lead of claim 30, wherein each of the plurality of
conductor lumens is configured and arranged to receive a plurality
of conductors of the plurality of conductors..Iaddend.
.Iadd.36. A method for manufacturing the lead of claim 30, the
method comprising: forming the multi-lumen conductor guide defining
the plurality of conductor lumens; and twisting a portion of the
multi-lumen conductor guide to form the helical
section..Iaddend.
.Iadd.37. The method of claim 36, wherein the helical section has
the pitch that is no more than 0.8 turns per
centimeter..Iaddend.
.Iadd.38. The method of claim 36, further comprising applying heat
to the multi-lumen conductor guide to set the helical
section..Iaddend.
.Iadd.39. The method of claim 36, wherein twisting the multi-lumen
conductor guide comprises twisting the multi-lumen conductor guide
to form helical pathways each having a pitch that is no greater
than 0.08 turns per centimeter..Iaddend.
.Iadd.40. The method of claim 36, wherein forming an elongated
multi-lumen conductor guide comprising extruding the multi-lumen
conductor guide and wherein twisting the multi-lumen conductor
guide comprises twisting the multi-lumen conductor guide while
extruding the multi-lumen conductor guide..Iaddend.
Description
FIELD
The invention is directed to the area of electrical stimulation
systems and methods of making and using the systems. The present
invention is also directed to electrical stimulation leads having
leads with improved flexibility and strain relief, as well as
methods of making and using the leads and electrical stimulation
systems.
BACKGROUND
Electrical Stimulation can be useful for treating a variety of
conditions. 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.
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
In one embodiment, a method for manufacturing a lead includes
forming an elongated multi-lumen conductor guide defining a central
stylet lumen and a plurality of conductor lumens arranged around
the stylet lumen. The multi-lumen conductor guide is twisted to
form at least one helical section where the plurality of conductor
lumens each forms a helical pathway around the stylet lumen. Each
of the helical pathways of the at least one helical section has a
pitch that is no less than 0.04 turns per centimeter. Optionally,
heat is applied to the multi-lumen conductor guide to set the at
least one helical section. Optionally, at least one conductor is
inserted into at least one of the plurality of conductor
lumens.
In another embodiment, a lead for providing deep brain stimulation
includes a lead body having a distal end, a proximal end, and a
longitudinal length. The lead body includes a multi-lumen conductor
guide extending from the proximal end of the lead body to the
distal end of the lead body. The multi-lumen conductor guide has an
outer surface and defines a central stylet lumen configured and
arranged for receiving a stylet and a plurality of conductor lumens
disposed around the central stylet lumen. Each conductor lumen is
configured and arranged to receive at least one conductor. The
plurality of conductor lumens are completely inset from the outer
surface of the multi-lumen conductor guide. At least a portion of
the multi-lumen conductor guide is twisted such that the
multi-lumen conductor guide forms at least one helical section
where the plurality of conductor lumens form helical pathways
around the stylet lumen. Each of the helical pathways of the at
least one helical section has a pitch that is no less than 0.04
turns per centimeter. A plurality of electrodes are disposed on the
distal end of the lead body. A plurality of lead terminals are
disposed on the proximal end of the lead body. A plurality of
conductors electrically couple at least one of the plurality of
electrodes to at least one of the plurality of lead terminals. The
plurality of conductors extend along the longitudinal length of the
leady body within the plurality of conductor lumens.
BRIEF DESCRIPTION OF THE DRAWINGS
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.
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:
FIG. 1 is a schematic side view of one embodiment of a brain
stimulation system that includes a lead, a lead extension, and a
control unit, according to the invention;
FIG. 2A is a schematic side view of one embodiment of a middle
portion of a lead being held in position by a retaining
feature;
FIG. 2B is a schematic side view of one embodiment of a middle
portion of the lead of FIG. 2A being held in position by the
retaining feature of FIG. 2A and a proximal end of the lead being
bent in a first direction, the bending of the proximal end causing
a corresponding deflection of an opposing distal end of the lead in
a second direction, opposite from the first direction;
FIG. 3 is a schematic side view of one embodiment of a middle
portion of the lead of FIG. 1 held in position by the retaining
feature of FIG. 2A and a proximal end of the lead being bent in a
first direction, the bending of the proximal end not causing any
corresponding deflections of an opposing distal end of the lead,
according to the invention;
FIG. 4A is a transverse cross-sectional view of one embodiment of
the lead of FIG. 1A, the lead including a multi-lumen conductor
guide that defines a central stylet lumen and a plurality of
conductor lumens arranged around the stylet lumen, according to the
invention;
FIG. 4B is a transverse cross-sectional view of one embodiment of
conductors disposed in each of a plurality of conductor lumens of
the multi-lumen conductor guide of FIG. 4A such that a different
single conductor is disposed in each of the conductor lumens,
according to the invention;
FIG. 5A is a transverse cross-sectional view of another embodiment
of the multi-lumen conductor guide of FIG. 4A, the multi-lumen
conductor guide defining a plurality of conductor lumens, each of
the plurality of conductor lumens receiving a plurality of
conductors, according to the invention;
FIG. 5B is a transverse cross-sectional view of yet another
embodiment of the multi-lumen conductor guide of FIG. 4A, the
multi-lumen conductor guide defining a plurality of conductor
lumens, each of the plurality of conductor lumens receiving a
plurality of conductors, according to the invention;
FIG. 5C is a transverse cross-sectional view of another embodiment
of the multi-lumen conductor guide of FIG. 4A, the multi-lumen
conductor guide defining a plurality of conductor lumens, each of
the plurality of conductor lumens receiving a plurality of
conductors, according to the invention;
FIG. 6A is a schematic side view of one embodiment of a helical
section of the multi-lumen conductor guide of FIG. 4A, the helical
section defining a plurality of conductor lumens each defining a
clockwise helical pathway around at least a portion of a stylet
lumen, according to the invention;
FIG. 6B is a schematic side view of another embodiment of a helical
section of the multi-lumen conductor guide of FIG. 4A, the helical
section defining a plurality of conductor lumens each defining a
counter-clockwise helical pathway around at least a portion of a
stylet lumen, according to the invention;
FIG. 7A is a schematic side view of one embodiment of a portion of
the multi-lumen conductor guide of FIG. 4A, the portion of the
multi-lumen conductor guide defining the discrete helical section
of either FIG. 6A or FIG. 6B, according to the invention;
FIG. 7B is a schematic side view of one embodiment of a portion of
the multi-lumen conductor guide of FIG. 4A, the portion of the
multi-lumen conductor guide defining a plurality of the discrete
helical sections of either FIG. 6A or FIG. 6B each separated from
one another by substantially-straight sections, according to the
invention;
FIG. 7C is a schematic side view of one embodiment of a portion of
the multi-lumen conductor guide of FIG. 4A, the portion of the
multi-lumen conductor guide defining a plurality of the discrete
helical sections of FIG. 6A and FIG. 6B abutting one another,
according to the invention;
FIG. 7D is a schematic side view of one embodiment of a portion of
the multi-lumen conductor guide of FIG. 4A, the portion of the
multi-lumen conductor guide defining a plurality of the discrete
helical sections of FIG. 6A and FIG. 6B with alternating winding
geometries, the helical sections each separated from one another by
substantially-straight sections, according to the invention;
and
FIG. 7E is a schematic side view of one embodiment of a portion of
the multi-lumen conductor guide of FIG. 4A, the portion of the
multi-lumen conductor guide defining a plurality of the discrete
helical sections of FIG. 6A and FIG. 6B, some of the helical
sections abutting one another and some of the helical sections
separated from one another by a substantially-straight section,
according to the invention.
DETAILED DESCRIPTION
The invention is directed to the area of electrical stimulation
systems and methods of making and using the systems. The present
invention is also directed to electrical stimulation leads having
leads with improved flexibility and strain relief, as well as
methods of making and using the leads and electrical stimulation
systems.
A lead for deep brain stimulation may include stimulation
electrodes, recording electrodes, or a combination of both. A
practitioner may determine the position of the target neurons using
the recording electrode(s) and then position the stimulation
electrode(s) accordingly without removal of a recording lead and
insertion of a stimulation lead. In some embodiments, the same
electrodes can be used for both recording and stimulation. In some
embodiments, separate leads can be used; one with recording
electrodes which identify target neurons, and a second lead with
stimulation electrodes that replaces the first after target neuron
identification. A lead may include recording electrodes spaced
around the circumference of the lead to more precisely determine
the position of the target neurons. In at least some embodiments,
the lead is rotatable so that the stimulation electrodes can be
aligned with the target neurons after the neurons have been located
using the recording electrodes.
Deep brain stimulation devices and leads are described in the art.
See, for instance, U.S. Patent Application Publication No.
2006/0149335 A1 ("Devices and Methods For Brain Stimulation"), U.S.
patent application Ser. No. 12/237,888 ("Leads With
Non-Circular-Shaped Distal Ends For Brain Stimulation Systems and
Methods of Making and Using"), U.S. Patent Application Publication
2007/0150036 A1 ("Stimulator Leads and Methods For Lead
Fabrication"), U.S. patent application Ser. No. 12/177,823 ("Lead
With Transition and Methods of Manufacture and Use"), U.S. patent
application Ser. No. 12/427,935 ("Electrodes For Stimulation Leads
and Methods of Manufacture and Use"), U.S. patent application Ser.
No. 61/170,037 ("Deep Brain Stimulation Current Steering with Split
Electrodes"), U.S. patent application Ser. No. 61/022,953, U.S.
patent application Ser. No. 61/316,759, and U.S. patent application
Ser. No. 12/356,480. Each of these references is incorporated
herein by reference in its respective entirety.
FIG. 1 illustrates one embodiment of an electrical stimulation
system 100 for brain stimulation. The electrical stimulation system
100 includes a lead 110, a plurality of electrodes 125 disposed at
least partially about a circumference of the lead 110, a plurality
of terminals 135, a lead extension 130 for connection of the
electrodes 125 to a control unit 160, and a stylet 140 for
assisting in insertion and positioning of the lead 110 in the
patient's brain. It may be advantageous to include the lead
extensions 130 to prevent having to remove or replace the lead 110
if the proximal end of the lead 110 fails due to fatigue (e.g.,
from flexing of the patient's neck, or the like).
The stylet 140 can be made of a rigid material. Examples of
suitable materials include tungsten, stainless steel, or plastic.
The stylet 140 may have a handle 150 to assist insertion into the
lead 110, as well as rotation of the stylet 140 and lead 110. The
lead extension 130 includes a connector 170 that fits over a
proximal end of the lead 110, preferably after removal of the
stylet 140.
The control unit 160 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 eight
stimulation channels which may be independently programmable to
control the magnitude of the current stimulus from each channel. In
some cases, the pulse generator may have more than eight
stimulation channels (e.g., 16-, 32-, or more stimulation
channels). The control unit 160 may have one, two, three, four, or
more connector ports, for receiving the plurality of terminals 135
at the proximal end of the lead 110.
In one example of operation, access to the desired stimulation
location 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" or "bur"), and coagulating and incising the dura
mater, or brain covering. The lead 110 can be inserted into the
cranium and brain tissue with the assistance of the stylet 140. The
lead 110 can be guided to the target stimulation location within
the brain using, for example, a stereotactic frame and a microdrive
motor system. In some embodiments, the microdrive motor system can
be 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 110, retract the lead 110, or
rotate the lead 110.
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 may observe the muscle and
provide feedback.
The lead 110 for deep brain stimulation can include stimulation
electrodes, recording electrodes, or both. In at least some
embodiments, the lead 110 has a cross-sectional diameter of no more
than 1.5 mm and may be in the range of 1 to 1.5 mm. In at least
some embodiments, the lead 110 is rotatable so that the stimulation
electrodes can be aligned with the target neurons after the neurons
have been located using the recording electrodes. Stimulation
electrodes may be disposed on the circumference of the lead 110 to
stimulate the target neurons. Stimulation electrodes may be
ring-shaped or segmented.
The lead extension 130 typically couples the electrodes 125 to the
control unit 160 (which typically houses a pulse generator that
supplies electrical signals to the electrodes 125). Connectors of
conventional lead extensions are typically disposed within patient
tissue such that the connectors are disposed over the patient's
skull and beneath or within the patient's scalp above one of the
patient's ear.
It may be desirable for a lead to be flexible. As discussed above,
during implantation a distal end of the lead is typically inserted
into a burr hole in the patient's scalp and positioned such that
the electrodes are disposed at a target stimulation location (e.g.,
the sub thalamic nucleus, the globus pallidus interna, the ventral
intermediate nucleus, or the like). A proximal end of the lead is
typically coupled to a connector of a lead extension, disposed
between the patient's skull and skin. In which case, the lead may
make an approximately 90.degree. bend in proximity to an outer
portion of the burr hole through which the distal end of the lead
is extended. Consequently, it may be desirable for the lead to be
flexible enough to be able to make such a bend.
Bending one portion of the lead, however, might cause a
corresponding undesired deflection at another portion of the lead.
For example, bending in a proximal portion or a middle portion of
the lead may cause a corresponding undesired deflection at a distal
end of the lead. Such a deflection may be caused, at least in part,
by one or more conductors of the lead being held in tension, while
one or more other conductors of the lead are held in compression.
FIG. 2A is a schematic side view of one embodiment of a lead 202
having a proximal end 204, a distal end 206, and a middle portion
208. The middle portion 208 of the lead 202 is held in position by
a retaining feature 210 (e.g., a burr hole plug or cap, bone
cement, one or more mini-plates, or the like). An axis 212 is shown
passing through the portion of the lead 202 extending through the
retaining feature 210. In FIG. 2A, the lead 202 is shown in a
straight configuration, such that the entire lead 202 extends along
the axis 212.
FIG. 2B is a schematic side view of one embodiment of the proximal
end 204 of the lead 202 bent in a first direction, away from the
axis 212, as shown by arrow 214. As shown in FIG. 2B, bending of
the proximal end 204 of the lead 202 in a first direction causes a
corresponding deflection of the distal end 206 of the lead 202 in a
second direction (opposite to the first direction), away from the
axis 212, as shown by arrow 216.
Accordingly, it may be desirable for the lead to include a strain
relief that prevents the bending of the lead proximal to a
retaining feature (e.g., a burr hole plug or cap, bone cement, one
or more mini-plates, or the like) from causing a corresponding
deflection of the lead distal to the retaining feature. As herein
described, the lead includes a lead body with an elongated
multi-lumen conductor guide configured and arranged to improve
flexibility from conventional lead bodies and to provide a strain
relief that prevents bending of a first end of the lead from
causing a corresponding deflection of an opposing end of the
lead.
FIG. 3 is a schematic side view of one embodiment of the lead 110.
The lead 110 has a proximal end 302, a middle portion 304, and a
distal end 306. The middle portion 304 is held in a relatively
stationary position by the retaining feature 210 (e.g., a burr hole
plug or cap, bone cement, one or more mini-plates, or the like). An
axis 312 is shown passing through the portion of the lead 110
extending through the retaining feature 210.
In FIG. 3, a portion of the lead 110 is shown bent in a first
direction from the axis 312, as shown by arrow 514. It will be
understood that the bend may occur at any suitable location along
the length of the lead 110. For example, in some cases the bend may
occur distal to the terminals and proximal to the electrodes. As
shown in FIG. 3, bending of a portion of the lead 110 in a first
direction does not cause a corresponding deflection of the distal
end 306 of the lead 110.
The multi-lumen conductor guide described herein includes multiple
conductor lumens arranged about a central stylet lumen. In at least
some cases, the conductor lumens are arranged about the central
stylet lumen such that there are no other lumens extending along
the multi-lumen conductor guide between the central stylet lumen
and each of the multiple conductor lumens. The conductor lumens
include at least one helical section forming an enclosed pathway
around at least a portion of the stylet lumen. In some cases, the
conductor lumens are each configured and arranged to receive a
single conductor. In other cases, at least one of the conductor
lumens is configured and arranged to receive multiple
conductors.
FIG. 4A is a transverse cross-sectional view of one embodiment of
the lead 110. The lead 110 includes an elongated multi-lumen
conductor guide 402. The multi-lumen conductor guide 402 may extend
an entire longitudinal length of the lead 110 from the electrodes
125 to the terminals 135. As shown in FIG. 4A, the multi-lumen
conductor guide 402 defines a central stylet lumen 404 and a
plurality of conductor lumens, such as conductor lumen 406. The
conductor lumens can have any suitable cross-sectional shape (e.g.,
round, oval, rectangular, triangular, or the like). In preferred
embodiments, the conductor lumens have round cross-sectional
shapes.
In at least some embodiments, the plurality of conductor lumens 406
are encapsulated by the multi-lumen conductor guide 402 such that
the conductor lumens 406 do not extend to an outer surface 408 of
the multi-lumen conductor guide 402. In which case, when conductors
(420 in FIG. 4B) are disposed in the conductor lumens 406, the
conductors are not exposed along the outer surface 408 of the
multi-lumen conductor guide 402. The stylet lumen 404 and the
plurality of conductor lumens 406 can be arranged in any suitable
manner. In preferred embodiments, the conductor lumens 406 are
disposed in the multi-lumen conductor guide 402 such that the
conductor lumens 406 are peripheral to the stylet lumen 404. In at
least some cases, the lead 110 may include one or more outer
coatings of material 410 disposed over the outer surface 408 of
multi-lumen conductor guide 402.
The stylet lumen 404 is configured and arranged to receive the
stylet 140. As discussed above, the stylet 140 can be used for
assisting in insertion and positioning of the lead 110 in the
patient's brain. The plurality of conductor lumens 406 are
configured and arranged to receive conductors, which electrically
couple the electrodes 125 to the terminals 135. FIG. 4B is a
transverse cross-sectional view of one embodiment of conductors,
such as conductor 420, disposed in the conductor lumens 406. In at
least some cases, insulation 422 is disposed around the conductors
420 to prevent short-circuiting of the conductors 420.
In some cases, two or more conductors 420 can be disposed in one or
more of the conductor lumens 406. In at least some cases, the
multi-lumen conductor guide 402 defines more than one conductor
lumen 406, yet includes fewer conductor lumens 406 than conductors
420. FIG. 5A-5C are transverse cross-sectional views of three other
embodiments of the multi-lumen conductor guide 402 defining the
stylet lumen 404 and a plurality of conductor lumens, such as
conductor lumen 406, where the number of conductor lumens 406 is
less than the number of conductors 420. Any suitable such
configuration can be implemented. In FIGS. 5A-5C, the multi-lumen
conductor guide 402 includes four conductor lumens 406 and eight
conductors 420. Each of the conductor lumens shown in FIG. 5A-5C
are configured and arranged to receive two conductors 420. In other
embodiments, at least one of the conductor lumens 406 can be
configured and arranged to receive a different number of conductors
than at least one other of the conductor lumens 406.
When the conductor lumens 406 are configured and arranged to
receive a plurality of conductors, the conductor lumens 406 can be
arranged in any suitable configuration. In FIGS. 5A-5C, the
conductor lumens 406 each have a major axis 502 and a minor axis
504 that is perpendicular to the major axis 502. In FIG. 5A, the
conductor lumens 406 are configured and arranged such that the
major axes 502 of the conductor lumens 406 extends radially outward
from the stylet lumen 404. In FIG. 5B, the conductor lumens 406 are
configured and arranged such that the minor axes 504 of the
conductor lumens 406 extends radially outward from the stylet lumen
404. In FIG. 5C, the conductor lumens 406 are configured and
arranged such that neither the major axes 502 nor the minor axis
504 of the conductor lumens 406 extend radially outward from the
stylet lumen 404.
FIGS. 6A and 6B are schematic side views of two embodiments of a
helical section 602 of the multi-lumen conductor guide 402. The
helical section 602 can extend an entire length of the multi-lumen
conductor guide 402, or one or more portions thereof. The
multi-lumen conductor guide 402 defines a plurality of conductor
lumens, such as conductor lumen 406, twisted such that the
individual conductor lumens 406 form helical pathways around the
stylet lumen 404. The conductor lumens 406 can extend in either
clockwise or counter-clockwise directions. In FIG. 6A, the
conductor lumens 406 are shown extending in a clockwise direction
around to the stylet lumen 404 (e.g., the conductor lumens 406 wrap
around the stylet lumen in a clockwise direction when the
multi-lumen conductor guide 402 is viewed from the distal end). In
FIG. 6B, the conductor lumens 406 are shown extending in a
counter-clockwise direction around to the stylet lumen 404 (e.g.,
the conductor lumens 406 wrap around the stylet lumen in a
counter-clockwise direction when the multi-lumen conductor guide
402 is viewed from the distal end). It should be understood that
the twisted lead embodiments of FIGS. 6A and 6B may have
transverse, cross-sections that are shown in FIGS. 4A, 4B, 5A, 5B
and 5C.
The conductor lumens 406 of the helical section 602 can be any
suitable pitch. The pitch can be either constant or variable. In
some cases, the pitch may be no less than 0.04 turns (i.e., 0.04
revolutions around a circumference of the stylet lumen 404) per cm.
In some cases, the pitch may be no less than 0.1 turns per cm. In
some cases, the pitch may be no less than 0.2 turns per cm. In some
cases, the pitch may be no less than 0.25 turns per cm. In some
cases, the pitch may be no greater than 0.8 turns per cm.
In some cases, the pitch may be no less than 0.04 turns per cm and
no greater than 0.8 turns per cm. In some cases, the pitch may be
no less than 0.1 turns per cm and no greater than 0.6 turns per cm.
In some cases, the pitch may be no less than 0.1 turns per cm and
no greater than 0.4 turns per cm. In some cases, the pitch may be
no less than 0.2 turns per cm and no greater than 0.4 turns per cm.
In some cases, the pitch may be approximately 0.3 turns per cm.
In some cases, for a 40 cm section of the multi-lumen conductor
guide 402, each conductor lumen 406 of the helical section 602
forms at least 2, 3, 4, or 5 turns. In some cases, for a 40 cm
section of the multi-lumen conductor guide 402, each conductor
lumen 406 of the helical section 602 forms no more than 25
turns.
In some cases, for a 40 cm section of the multi-lumen conductor
guide 402, each conductor lumen 406 of the helical section 602
forms no less than 2 turns and no more than 15 turns. In some
cases, for a 40 cm section of the multi-lumen conductor guide 402,
each conductor lumen 406 of the helical section 602 forms no less
than 3 turns and no more than 15 turns. In some cases, for a 40 cm
section of the multi-lumen conductor guide 402, each conductor
lumen 406 of the helical section 602 forms no less than 4 turns and
no more than 15 turns. In some cases, for a 40 cm section of the
multi-lumen conductor guide 402, each conductor lumen 406 of the
helical section 602 forms no less than 5 turns and no more than 15
turns.
The conductor lumens 406 of the helical section 602 can be
configured into any suitable arrangement (see e.g., FIGS. 4A-5C).
The helical section 602 may include a single layer of conductor
lumens 406 disposed over the stylet lumen 404. The conductor lumens
406 may be disposed over a single stylet lumen 404. In some cases,
a single layer of conductor lumens 406 is disposed over a single
stylet lumen 404.
In some cases, the helical section 602 extends along an entire
length of the lead 110 between the electrodes (125 in FIG. 1) and
the terminals (135 in FIG. 1). In other cases, the helical section
602 extends along one or more discrete sections of the lead 110.
When the helical section 602 extends along one or more discrete
sections of the lead 110, the discrete helical section 602 can be
any suitable length. In some cases, the discrete helical section
602 is at least 1 cm, 2 cm, 3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9
cm, 10 cm, 15 cm, 20 cm, 25 cm, 30 cm, or longer.
Turning to FIG. 7A, when the helical section 602 extends along a
discrete section of the multi-lumen conductor guide 402, the
discrete helical section 602 can be disposed at any suitable
location along the length of the lead 110. In some cases, the
discrete helical section 110 may abut the electrodes (125 in FIG.
1), the terminals (135 in FIG. 1), or both. In other cases, the
discrete helical section 602 can be disposed somewhere along the
length of the lead 110 between the electrodes (125 in FIG. 1) and
the terminals (135 in FIG. 1). When the discrete helical section
602 is disposed somewhere along the length of the lead 110 between
the electrodes (125 in FIG. 1) and the terminals (135 in FIG. 1),
the remaining portions of the conductor lumens 406 can be arranged
into one or more other configurations, such as a
substantially-straight configuration (e.g., the conductor lumens
406 extend less than one revolution about a circumference of the
stylet lumen 404 along a 20 cm length of the multi-lumen conductor
guide 402).
FIG. 7A is a schematic side view of one embodiment of a portion of
the multi-lumen conductor guide 402. The portion of the multi-lumen
conductor guide 402 defines a discrete helical section 702 where
each of a plurality of conductor lumens defines a helical pathway
around at least a portion of a circumference of a stylet lumen. In
FIG. 7A, substantially-straight sections 704 of the conductor
lumens extend along the multi-lumen conductor guide 402 on either
end of the discrete helical section 702. The helical section 702
and the flanking substantially-straight sections 704 can be any
suitable lengths relative to one another.
Turning to FIG. 7B, in some cases the multi-lumen conductor guide
includes a plurality of helical sections. When the lead includes a
plurality of helical sections, the conductor lumens of the helical
sections can extend around the stylet lumen in either: a clockwise
direction; a counter-clockwise direction; or a combination of both,
where at least one conductor lumen extends clockwise and at least
one conductor lumen that extends counter-clockwise around the
circumference of the stylet lumen. In some cases, when the
multi-lumen conductor guide includes a plurality of helical
sections, the helical sections each have equal lengths. In other
cases, when the lead includes a plurality of helical sections, at
least one of the helical sections has a length that is different
from at least one other of the plurality of helical sections.
FIG. 7B is a schematic side view of one embodiment of a portion of
the multi-lumen conductor guide 402. The portion of the multi-lumen
conductor guide 402 defines a plurality of the discrete helical
sections 702. In FIG. 7B, a substantially-straight section 704 is
disposed between the discrete helical sections 702.
Turning to FIG. 7C, in some cases the multi-lumen conductor
includes two abutting discrete helical sections with conductors
winding in opposite directions. FIG. 7C is a schematic side view of
one embodiment of a portion of the multi-lumen conductor guide 402.
The portion of the multi-lumen conductor guide 402 defines a
plurality of the discrete helical sections abutting one another. At
least one of the helical sections 702a includes conductor lumens
arranged in a clockwise configuration, and at least one of the
helical sections 702b includes conductor lumens arranged in a
counter-clockwise configuration.
Turning to FIG. 7D, in some cases the multi-lumen conductor
includes multiple discrete helical sections with conductors winding
in opposite directions, where the discrete helical sections are
separated from one another by substantially-straight sections. FIG.
7D is a schematic side view of one embodiment of a portion of the
multi-lumen conductor guide 402. The portion of the multi-lumen
conductor guide 402 defines a plurality of discrete helical
sections 702a and 702b. The helical sections alternate between
helical sections 702a having conductor lumens arranged in a
clockwise configuration, and helical sections 702b having conductor
lumens arranged in a counter-clockwise configuration. A
substantially-straight section 704 separates each of the
alternating helical sections 702a and 702b from one another.
FIG. 7E is a schematic side view of one embodiment of a portion of
the multi-lumen conductor guide 402. The portion of the multi-lumen
conductor guide 402 defines a plurality of discrete helical
sections. At least some of the helical sections, such as helical
sections 702a and 702b.sub.1, abut one another. At least some of
the helical sections, such as helical sections 702a and 702b.sub.2,
are separated from one another by a substantially-straight section
704. Additionally, at least one of the helical sections, such as
helical section 702a includes conductor lumens arranged in a
clockwise configuration, and at least one of the helical sections,
such as helical sections 702b.sub.1 and 702b.sub.2, include
conductor lumens arranged in a counter-clockwise configuration.
The multi-lumen conductor guide 402 can be formed as a single-piece
component or as a multi-piece component. The multi-lumen conductor
guide 402 can be formed from any suitable material(s). For example,
the multi-lumen conductor guide 402 can be formed from one or more
thermoset polymers, thermoplastic polymers (e.g., polyurethane, or
the like), silicone, or the like or combinations thereof.
The multi-lumen conductor guide 402 can be formed in any suitable
manner. For example, the multi-lumen conductor guide 402 can be
extruded. In some cases, the multi-lumen conductor guide 402 can be
twisted as the multi-lumen conductor guide 402 is being extruded,
or after extrusion.
The multi-lumen conductor guide 402 can be formed such that the
conductor lumens are in substantially-straight configurations. In
some cases, the multi-lumen conductor guide 402 (or one or more
portions thereof) with the substantially-straight conductor-lumen
configurations can be twisted, as desired, to form one or more
helical sections. Once the twisting is complete, the twisted
multi-lumen conductor guide can be heated to set the helical
section(s). In other cases, the multi-lumen conductor guide can be
heated prior to twisting. In yet other cases, the multi-lumen
conductor guide can be heated while being twisted. The heating can
be performed using at least one of: one or more transverse heating
elements which heat one or more particular portions of the
multi-lumen conductor guide at a time, or an elongated heating
element that heats the entire multi-lumen conductor guide at once.
In some cases, the lead can be heated from the inside out, for
example, by using one or more heating elements disposed in the
stylet lumen.
In some cases, the conductors can be disposed in the conductor
lumens prior to heating. In other cases, the conductor lumens can
be empty during heating. In preferred embodiments, one or more
mandrels are disposed in at least some of the conductor lumens. It
may be advantageous to dispose mandrels in the conductor lumens
prior to heating of the multi-lumen conductor guide to prevent the
conductor lumens from collapsing during heating.
In at least some cases, a different mandrel is disposed in each of
the conductor lumens during the heating process and then removed
for insertion of the conductors. Optionally, a mandrel can be
disposed in the stylet lumen. The mandrels disposed in the
conductor lumens can have any suitable diameter. In at least some
cases, the mandrels have diameters that are smaller than diameters
of the conductor lumens, yet larger than diameters of the
conductors. It may be advantageous to use mandrels with diameters
that are smaller than diameters of the conductor lumens, yet larger
than diameters of the conductors so that, during the heating
process, the conductor lumens do not shrink to a size that prevents
(or makes difficult) insertion of the conductors into the conductor
lumens after the multi-lumen conductor guide is twisted and heated,
and the mandrels are removed.
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.
* * * * *