U.S. patent application number 17/101773 was filed with the patent office on 2021-04-01 for systems, devices and methods for implantable neuromodulation stimulation.
The applicant listed for this patent is SynerFuse, Inc.. Invention is credited to Kyle R. Grube, Kathleen W. Hill, Matthew A. Hunt, Beth A. Lindborg, Gregory F. Molnar, Michael C. Park, Nazmi Peyman, Justin D. Zenanko.
Application Number | 20210093875 17/101773 |
Document ID | / |
Family ID | 1000005264045 |
Filed Date | 2021-04-01 |
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United States Patent
Application |
20210093875 |
Kind Code |
A1 |
Molnar; Gregory F. ; et
al. |
April 1, 2021 |
SYSTEMS, DEVICES AND METHODS FOR IMPLANTABLE NEUROMODULATION
STIMULATION
Abstract
The present invention comprises implantable neuromodulation
systems and methods comprising a protective pouch that at least
partially encases an implantable pulse generator prior to
implanting in a patient and is adapted to be secured within the
surgical site. The pouch may be secured to a pedicle screw and/or a
fixation rod, or to a vertebral body.
Inventors: |
Molnar; Gregory F.; (Blaine,
MN) ; Peyman; Nazmi; (Glen Allen, VA) ;
Zenanko; Justin D.; (Minnetrista, MN) ; Lindborg;
Beth A.; (St. Paul, MN) ; Hill; Kathleen W.;
(St. Paul, MN) ; Grube; Kyle R.; (Minneapolis,
MN) ; Park; Michael C.; (Excelsior, MN) ;
Hunt; Matthew A.; (Minneapolis, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
SynerFuse, Inc. |
Minneapolis |
MN |
US |
|
|
Family ID: |
1000005264045 |
Appl. No.: |
17/101773 |
Filed: |
November 23, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16665525 |
Oct 28, 2019 |
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17101773 |
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62752223 |
Oct 29, 2018 |
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62793319 |
Jan 16, 2019 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 1/0551 20130101;
A61N 1/37518 20170801; A61B 2017/564 20130101; A61B 17/7001
20130101; A61N 1/36071 20130101; A61N 1/36062 20170801 |
International
Class: |
A61N 1/375 20060101
A61N001/375; A61N 1/05 20060101 A61N001/05; A61N 1/36 20060101
A61N001/36; A61B 17/70 20060101 A61B017/70 |
Claims
1. A pouch for at least partially encasing an implantable pulse
generator ("IPG") for implantation within a surgical site, the
pouch comprising: opposing first and second major surface walls;
wherein the opposing first and second major surface walls define an
interior plenum that is configured to receive and at least
partially enclose the IPG therein, wherein the pouch is adapted to
be secured within the surgical site; one or more apertures or
discontinuities in the pouch sized and adapted to allow at least
one electrical lead operatively connected to the IPG to pass
through the pouch; and an attachment surface extending from the
pouch, the attachment surface adapted for attaching the pouch to a
pedical screw disposed within the surgical site.
2. The pouch of claim 2, wherein the pedicle screw comprises a
pedicle screw head defining at least one receiving wall, and
wherein the attachment surface comprises at least one side wall
adapted to engage a corresponding receiving wall of the pedicle
screw head.
3. The pouch of claim 2, wherein the IPG is at least partially
encased within the pouch and wherein the attachment surface is
adapted to maintain the IPG and the pouch in a fixed relationship
with respect to the pedicle screw.
4. The pouch of claim 3, further comprising a connecting element
configured to engage a portion of a fixation rod.
5. The pouch of claim 4, wherein the portion of the connecting
element that engages a portion of the fixation rod further
comprises a contoured end wall.
6. The pouch of claim 1, further comprising at least one additional
wall disposed between the first and second major surface walls.
7. The pouch of claim 1, wherein the pouch is coated or impregnated
with at least one material having one or more of the properties of
the group consisting of antimicrobial, antifungal, antibiotic,
anti-infection, analgesic properties, drug-eluting, tissue growth
inhibiting, and tissue growth enhancing.
8. A pouch for at least partially encasing an implantable pulse
generator ("IPG") for implantation within a surgical site, the
pouch comprising: opposing first and second major surface walls;
wherein the opposing first and second major surface walls define an
interior plenum that is configured to receive and at least
partially enclose the IPG therein, wherein the pouch is adapted to
be secured within the surgical site; one or more apertures or
discontinuities in the pouch sized and adapted to allow at least
one electrical lead operatively connected to the IPG to pass
through the pouch; and an attachment member extending from a
portion of the pouch adapted to engage a fixation rod.
9. The pouch of claim 8, further comprising an outwardly extending
connecting element adapted to engage the fixation rod.
10. The pouch of claim 9, wherein the outwardly extending
connecting element comprises a contoured engagement surface for
engaging the outer surface of the fixation rod.
11. The pouch of claim 10, wherein the contoured engagement surface
comprises a complementary shape with respect to the outer surface
of the fixation rod.
12. The pouch of claim 8, wherein the attachment member is adapted
to maintain the pouch in a fixed relationship with the fixation
rod.
13. The pouch of claim 8, wherein the pouch is coated or
impregnated with at least one material having one or more of the
properties of the group consisting of antimicrobial, antifungal,
antibiotic, anti-infection, analgesic properties, drug-eluting,
tissue growth inhibiting, and tissue growth enhancing.
14. A method for treating pain generated by a patient's spinal
column in a combined procedure using vertebral stabilization and
neuromodulation stimulation, comprising: identifying two or more
targeted vertebral levels for vertebral stabilization; identifying
one or more targeted spinal levels for neuromodulation stimulation,
including at least one targeted dorsal root ganglion; creating an
open access into the resulting spinal treatment site to provide
direct visual access to the identified targeted vertebral levels
and the at least one identified targeted spinal level and the at
least one targeted dorsal root ganglion; stabilizing the identified
vertebral levels; and placing a neuromodulation system comprising:
an implantable pulse generator, wherein the implantable pulse
generator is at least partially enclosed within a biocompatible
pouch, wherein the biocompatible pouch is secured within the spinal
treatment site, at least one electrical lead in operative
electrical communication with the implantable pulse generator,
wherein the at least one electrical lead is routed from the
implantable pulse generator through at least one aperture in the
biocompatible pouch to a location within therapeutic proximity of
the at least one targeted dorsal root ganglion at each of the one
or more target spinal levels, and at least one electrode disposed
at a distal end of the at least one electrical lead, wherein the at
least one electrode is placed in therapeutic proximity with each of
the at least one targeted dorsal root ganglion at each of the one
or more target spinal levels; and closing the open access.
15. The method of claim 13, wherein the stabilizing of the
identified vertebral levels comprises securing the identified
vertebral levels with two bilaterally spaced apart fixation rods,
wherein each fixation rod is secured to vertebral bone with two or
more pedicle screws; and securing the biocompatible pouch to at
least one of the group consisting of: a pedicle screw, a fixation
rod, and a vertebral body.
16. A method for treating pain generated by a patient's spinal
column in a combined procedure using neuromodulation stimulation,
comprising: identifying one or more targeted spinal levels for
neuromodulation stimulation, including at least one targeted dorsal
root ganglion; creating an open access into the resulting spinal
treatment site to provide direct visual access to the at least one
identified targeted spinal level and the at least one targeted
dorsal root ganglion; placing a neuromodulation system comprising:
an implantable pulse generator, wherein the implantable pulse
generator is at least partially enclosed within a biocompatible
pouch, wherein the biocompatible pouch is secured within the spinal
treatment site, at least one electrical lead in operative
electrical communication with the implantable pulse generator,
wherein the at least one electrical lead is routed from the
implantable pulse generator through at least one aperture in the
biocompatible pouch to a location within therapeutic proximity of
the at least one targeted dorsal root ganglion at each of the one
or more target spinal levels, and at least one electrode disposed
at a distal end of the at least one electrical lead, wherein the at
least one electrode is placed in therapeutic proximity with each of
the at least one targeted dorsal root ganglion at each of the one
or more target spinal levels; and closing the open access.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This is a divisional of U.S. Non-Provisional patent
application Ser. No. 16/665,525, filed Oct. 28, 2019 and claims
priority to U.S. Provisional Patent Application No. 62/752,223,
filed Oct. 29, 2018 and titled IMPLANTABLE NEUROMODULATION SYSTEM
AND KIT and U.S. Provisional Patent Application No. 62/793,319,
filed Jan. 16, 2019 and titled NEUROMODULATION THERAPIES AND
IMPROVED NEUROMODULATION SYSTEMS, the contents of which are hereby
incorporated by reference in their entirety.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
[0002] Not Applicable
BACKGROUND OF THE INVENTION
Field of the Invention
[0003] The invention relates to a system and/or method for treating
chronic spinal pain comprising a surgical procedure combining a
spinal procedure such as vertebral fusion with implantation of a
neuromodulation device, wherein the surgical procedure is conducted
with open physical and visual access to the region of the spine
undergoing treatment.
Description of the Related Art
[0004] A neuromodulation procedure in accordance with the present
invention is performed at a spinal treatment site. The
neuromodulation procedure includes the placement of one or more
neurostimulation leads at one or more target spinal levels, and
more specifically, at the dorsal root ganglia at each of the target
spinal levels.
[0005] The neurostimulation leads include a distal portion having
one or more electrodes positioned at the distal portion, the
neurostimulation leads further having a proximal portion capable of
coupling to an implantable pulse generator. The neurostimulation
lead further includes one or more electrically conductive wires
capable of receiving an electrical signal in a distal portion, when
electrically coupled to a pulse generator. The neurostimulation
leads, when coupled to an implantable pulse generator, are then
capable of delivering an electrical signal via the electrodes to a
target site, such as a target dorsal root ganglia.
[0006] The procedure for placing of the neurostimulation leads may
include placing the distal segment of one or more neurostimulation
leads at the corresponding one or more target dorsal root ganglia
such that the one or more electrodes of the neurostimulation lead
is in therapeutic proximity to the target dorsal root ganglia such
that when the neurostimulation lead is coupled to an implantable
pulse generator and an electrical signal is delivered to the target
dorsal root ganglia via the implantable pulse generator such
electrical signal results in neuromodulation of the target dorsal
root ganglia.
[0007] The neuromodulation procedure may further include routing of
the proximal portion of the neurostimulation lead to the
implantable pulse generator. The implantable pulse generator may be
placed during the spinal procedure in an anatomical location that
is dependent upon the particular treatment procedure performed or
dependent upon physician preference or dependent upon patient
preference or some combination thereof.
[0008] Once the implantable pulse generator has been electrically
coupled to the leads, the pulse generator can be activated to
deliver, via the one or more neurostimulation leads, a
neuromodulation therapy to the spinal treatment site.
[0009] Anchoring and/or securing the implantable pulse generator
within the surgical site would be advantageous.
[0010] Anchoring and/or securing the electrical lead(s) along at
least part of their length would be advantageous.
[0011] Providing an electrical lead placement tool to facilitate
translation and placement of the electrode at the site of interest,
e.g., in therapeutic proximity to a dorsal root ganglion, would be
advantageous.
[0012] The Figures and the Detailed Description which follow more
particularly exemplify these and other embodiments of the
invention.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0013] FIG. 1A is a view of one embodiment of the present
invention.
[0014] FIG. 1B is a view of the embodiment of FIG. 1A implanted
into a patient's anatomy.
[0015] FIG. 1C is a view of the embodiment of FIG. 1A implanted
into a patient's anatomy.
[0016] FIG. 1D is a view of the embodiment of FIG. 1A implanted
into a patient's anatomy.
[0017] FIG. 1E is a perspective view of one embodiment of the
present invention.
[0018] FIG. 2 is a top view of one embodiment of the present
invention.
[0019] FIG. 3A is a top view of one embodiment of the present
invention.
[0020] FIG. 3B is a top view of one embodiment of the present
invention.
[0021] FIG. 4 is a top view of one embodiment of the present
invention.
[0022] FIG. 5A is a top view of one embodiment of the present
invention.
[0023] FIG. 5B is a side view of the embodiment of FIG. 5A.
[0024] FIG. 6A is a top view of one embodiment of the present
invention.
[0025] FIG. 6B is a side view of the embodiment of FIG. 6A.
[0026] FIG. 7A is a side view of one embodiment of the present
invention.
[0027] FIG. 7B is a top view of the embodiment of FIG. 7A.
[0028] FIG. 7C is a side view of one embodiment of the present
invention.
[0029] FIG. 7D is a perspective view of one embodiment of the
present invention.
[0030] FIG. 7E is a side view of one embodiment of the present
invention.
[0031] FIG. 7F is a perspective view of one embodiment of the
present invention.
[0032] FIG. 7G is a perspective view of one embodiment of the
present invention.
[0033] FIG. 8 is a side view of one embodiment of the present
invention.
[0034] FIG. 9A is a top view of one embodiment of the present
invention.
[0035] FIG. 9B is a top view of one embodiment of the present
invention.
[0036] FIG. 10A is a fluoroscopic image of one embodiment of the
present invention.
[0037] FIG. 10B is a fluoroscopic image of one embodiment of the
present invention.
[0038] FIG. 11 is a top view of one embodiment of the present
invention.
DETAILED DESCRIPTION OF THE INVENTION
[0039] The present invention provides a system and kit for
improving and enhancing the implantation of a neuromodulation
device alone or in combination with a spinal fixation or other
spinal treatment procedure. The present invention further provides
a system and kit for placing and anchoring the implantable pulse
generator and leads at a spinal treatment site. The present
invention provides embodiments for a pouch for encasing an
implantable pulse generator. The pouch having one or more
attachment members for anchoring, tethering or fixating the pouch
to a target anchor site. The pouch encasing the implantable pulse
generator is adapted to be secured within the surgical site. The
pouch may be secured to a pedicle screw and/or a fixation rod, or
to a vertebral body.
[0040] Various embodiments of the present invention may be
implemented with implantation of a neuromodulation device or
system, either alone or in combination with a spinal fixation or
other spinal treatment procedure within a surgical site.
[0041] FIG. 1A illustrates an implantable pulse generator (IPG) 2
with electrical leads 6 attached thereto. The IPG is at least
partially enclosed in a pouch 100 and the leads 6 extend through
the pouch 100 to the site of interest. The pouch 100 includes pouch
walls W1, W2, W3 and/or W4, and/or W5, and/or W6 that may be
defined relative to the implantable pulse generator 2. The pouch
100 includes first and second opposing walls W1 and W2,
respectively, corresponding to the two major surfaces of the
implantable pulse generator 2. The pouch 100 further includes one
or more side-walls including any of walls W3-W6 extending between
the two major surfaces and connecting the two opposing major
surfaces W1 and W2 to each other. FIG. 1E provides an exemplary
embodiment for pouch 100.
[0042] The pouch 100 walls W1-W6 may enclose all or only a portion
of the corresponding side of the implantable pulse generator. As
the skilled artisan will readily recognize, one or more of the side
walls W3-W6 may be eliminated, wherein the major surface walls W1
and W2 are connected or integrated with each other directly. In the
most extreme embodiment, Walls W1 and W2 are the only surfaces
required. A sealable opening may be provided along one of the walls
W1-W6 to allow insertion of the IPG 2 into the pouches interior
defined by walls and then the opening may be sealed closed with the
IPG 2 sealed inside.
[0043] One or more of pouch walls W1-W6 may further include one or
more apertures A or discontinuities, including an aperture for
allowing leads to extend through the pouch 100 wall and couple to
the implantable pulse generator 2. Additional apertures A and
discontinuities may be defined by the pouch wall in accordance with
design preferences, functional benefits and application
requirements. For example, without limitation, one or more
apertures A or discontinuities may be incorporated into one or more
pouch walls in order to allow tissue to anchor to the pouch when
implanted in a patient's anatomy.
[0044] Alternatively, a continuous planar surface may be
intentionally used on at least a portion of the pouch 100 to
minimize tissue growth into, on or near that section of the pouch
1. As yet another alternative, one or more wall may be defined only
by a narrow strip of pouch 100 material extending across a larger
corresponding surface of the implantable pulse generator 2.
[0045] The pouch 100 has an interior space I defined by the pouch
100 walls W1, W2 and/or W3-W6, whether or not such pouch walls
include one or more apertures A or discontinuities. The interior
space defines a plenum for receiving an implantable pulse
generator.
[0046] The interior space I may be dimensioned such that each wall
W1, W2 and/or W3-W6 of the pouch 100 is in direct contact with a
corresponding surface the implantable pulse generator 2 providing a
snug fit around the IPG 2. Alternatively, only one or less then all
of the interior surfaces of walls W1, W2 and/or W3-W6 of the pouch
100 may be in direct contact with the corresponding nearest surface
of the implantable pulse generator 2, or such that only a portion
of a given interior wall surface of the pouch 100 is in contact
with a corresponding surface of the implantable pulse generator 2
to provide a loose fit.
[0047] The pouch 100 is made of a biocompatible material, such as
medical grade silicone or other medical grade thermoplastic
polymers capable of being implanted in a human anatomy. The
properties of the pouch 100 may include a flexible, rubber-like
attribute such that it is slightly to moderately deformable yet
sufficiently rigid to maintain its general pouch shape. Suitable
materials may include, but are not limited to, silicone rubber
manufactured by Simtec at 9658 Premier Parkway, Miramar, Fla.
[0048] The pouch 100 may further be coated or impregnated with one
or more chemicals or materials having additional biological and/or
physiological activities or characteristics. Such attributes may
include but are not limited to: antimicrobial, antifungal,
antibiotic, anti-infection, analgesic properties, drug-eluting,
tissue growth inhibiting, tissue growth enhancing, and combinations
thereof.
[0049] The pouch 100, in accordance with the present invention, may
be manufactured in various dimensions in order to define an
interior surface capable of receiving an implantable pulse
generator 2 having complimentary dimensions. There are many
implantable pulse generators with varying dimensions and as such a
pouch 100 may be dimensioned to the specific dimensions of a
specific implantable pulse generator 2 or the pouch 100 may be
dimensioned to approximately enclose a wide range of implantable
pulse generators. Alternatively, the pouch 100 may be adjustable
along one or more dimensions in order to accommodate implantable
pulse generators of different dimensions.
[0050] As shown in FIGS. 1B-1D, the pouch 100 may be used in
conjunction with an implantable pulse generator 2 implanted to
provide a neuromodulation therapy to one or more target dorsal root
ganglia. Such an implantable pulse generator 2 may be substantially
smaller in size than implantable pulse generators traditionally
used in spinal cord stimulation. Specifically, the implantable
pulse generator 2 shown in FIGS. 1B-1D may have a volume of 11
cubic centimeters, or between 3 cubic centimeters and 10 cubic
centimeters, or between 1 cubic centimeters and 3 cubic
centimeters, or less than 1 cubic centimeter. As such, the pouch
100 may be dimensioned such that an interior surface defines a
shape and volume corresponding to that of the implantable pulse
generator 2.
[0051] As shown in FIG. 1B, an implantable pulse generator 2 may be
received within a pouch 100 and the combination results in a
pouch-encased implantable pulse generator 2, or at least partially
encased or enclosed within the pouch 100. The pouch-encased
implantable pulse generator 2 may be implanted in the tissue of the
patient anatomy located at the flank as generally shown in FIG. 1B.
As described, the implantable pulse generator 2 may be completely
or partially enclosed or encased within pouch 100.
[0052] As shown in FIG. 1C, a pouch-encased implantable pulse
generator 2 may be implanted along the spine 7 of a patient
anatomy. The pouch-encased implantable pulse generator 2 may be
implanted at a section of the patient anatomy where bone has been
removed from the spinal treatment site, or it may be implanted next
to, at, or near an existing spinal process of the patient
anatomy.
[0053] As shown in FIG. 1D, a pouch 100 encased implantable pulse
generator 2 may be implanted remotely from a spinal treatment site.
A junction box 8 may, in some embodiments, be implanted at or near
the spinal treatment site and leads extend from the junction box 8
to the remotely positioned pouch 100 encased implantable pulse
generator 2. Alternatively, junction box 8 may be operatively
electrically connected with IPG 2 with leads 6 extending from
junction box 8 to the site of interest, e.g., a dorsal root
ganglion.
[0054] The pouch-encased implantable pulse generator 2 may be
implanted by a variety of methods and sequences. The pouch-encased
implantable pulse generator 2 may be implanted during and in
combination with an open back spinal fixation, or other spinal,
procedure, prior to or after such spinal procedure has been
completed, as a procedure independent of a spinal procedure, as a
minimally invasive procedure and/or as part of a revision
procedure.
[0055] FIG. 2 shows an implantable pulse generator 2 encased in a
pouch 100 as described above and implanted over the spine 7 of a
patient anatomy at a spinal treatment site. The implantable pulse
generator 2 is dimensioned such that it is positioned at a spinal
treatment site between a pair of spinal fixation rods 4 for fixing
relative motion between affected vertebrae. The implantable pulse
generator 2 may be positioned between two existing spinous
processes or in the bone removed portion of a spinal treatment
site.
[0056] The pouch 100 at least partially encasing the implantable
pulse generator 2 may include one or more attachment elements for
anchoring the pouch 100 to a corresponding one or more spinal
fixation rods 4. The attachment elements in the present embodiment
may comprise non-rigid looped attachment members 3 that extend from
the pouch 100 to a remotely positioned pedicle screw 5. The
non-rigid looped attachment members 3 comprise a flexible medical
grade material having elastic rubber-band like properties such that
the attachment members provide a releasable tension that allows for
connecting of the pouch 100 to the pedicle screw 5 by looping a
portion of the attachment member around the pedicle screw 5.
[0057] When the non-rigid looped attachment members 3 are
operatively connected to and/or looped around the pedicle screw 5,
the pouch 100 is maintained in a tethered relationship to the
pedicle screw 5 by the tension in the portion of the non-rigid
looped attachment member 3 extending from the pedicle screw 5 to
the pouch 100. The pouch 100 may be attached to two separate
pedicle screws 5 via separate attachment members 3 or separate
portions of a single tension member such that it is maintained in
relative position to the spinal fixation rods 4.
[0058] FIGS. 3A and 3B show an implantable pulse generator 2 at
least partially encased in a pouch 100 as described above and
positioned between a pair of spinal fixation rods 4. The pouch may
include one or more attachment elements or tethers 9 extending from
a first end, or a wall W1-W6 as shown in FIG. 1E, at the pouch 100
to a second end, or a wall W1-W6, coupled to a spinal fixation rod
4. The second end of the attachment element or tether 9 may be
coupled to the spinal fixation rod 4 with a grip 10 for maintaining
a connection between the second end of the attachment element or
tether 9 and the corresponding spinal fixation rod 4.
[0059] In FIG. 3A a first single grip 10 is shown attached to a
single corresponding first fixation rod 4, two attachment members
or tethers 9 extend from a first end at the pouch 100 to a second
end at the first single grip 10 to tether the pouch 100 to the
first fixation rod 4.
[0060] A second single grip 10 is shown attached to a single
corresponding second fixation rod 4. Two attachment members or
tethers 9 extend from a first end at the pouch 100 to a second end
at the second single grip to tether the pouch 100 to the second
fixation rod 4.
[0061] In FIG. 3B, four separate attachment members or tethers 9
are shown, each extending from a first end at the pouch 100 to a
second end at a corresponding grip 10 to couple the pouch 100 to
the corresponding first and second fixation rods 4 in a generally
X-type relationship.
[0062] The attachment elements or tethers 9 in FIGS. 3A and 3B may
be flexible and elastic in performance so as to maintain a tension
between the first and second end of the attachment member or tether
9 when extending between the pouch 100 and grips 10.
[0063] Alternatively, the attachment members or tethers 9 may be
non-flexible or minimally flexible and merely tether the pouch 100
to the fixation rod 4 without providing tension therebetween.
[0064] Whether the attachment elements or tethers 9 are
flexible/elastic or non to minimally flexible, the pouch 100, and
encased implantable pulse generator 2, will be anchored between the
fixation rods 4 but will be able to float within a predetermined
volume of space to a greater or lesser extend depending upon the
flexibility and slack of the attachment elements or tethers 9.
[0065] FIG. 4 illustrates an implantable pulse generator 2 encased
in a pouch 100 as described above. The pouch-encased implantable
pulse generator 2 may be positionable next to the vertebral body of
a spinal treatment site as shown, or between adjacent vertebral
bodies of a spinal treatment site. One or more attachment elements
or tethers 9 as described above are shown having a first end
extending from the pouch 100 and a second end extending to a grip
10, also as described above. However, in this embodiment, the
attachment elements or tethers 9 provide a tethered fixation of the
pouch 100 to a portion of a vertebral body, instead of a fixation
rod 4, by grip 10 coupled to the second end of the attachment
element 9. The attachment elements or tethers 9, when engaged with
a vertebral body by corresponding grips 10, maintain the pouch 100
encased implantable pulse generator 2 in a tethered relationship
with respect to the vertebral body. This feature also allows our
implantable pulse generator device to be implanted and fixated by a
surgeon independent of any spinal fixation components. This could
also be delivered and fixated by way of a minimally invasive spinal
surgical approach.
[0066] FIGS. 5A-5B illustrate a pouch 100 encased implantable pulse
generator 2 wherein the pouch 100 includes an attachment surface 18
extending from a portion of the pouch 100 for attaching the pouch
100 to a pedicle screw 5. The attachment surface 18 may comprise
one or more contoured side walls configured to mate with a
corresponding receiving wall of the pedicle screw 5 head. The
connecting element further includes a contoured end wall configured
to engage a portion of a fixation rod 4. The attachment surface 18
shown in FIGS. 5A and 5B maintains the pouch 100 encased
implantable pulse generator 2 in a fixed relationship with respect
to the pedicle screw 5 to which it is attached.
[0067] FIGS. 6A-6B illustrate a pouch 100 encased implantable pulse
generator 2 wherein the pouch 100 includes an attachment member 20
extending from a portion of the pouch body for attaching the pouch
to a fixation rod. The attachment member 20 includes an outwardly
extending connecting element having a contoured and/or
complementary engagement surface for engaging the outer surface of
a fixation rod 4. The attachment member 20 shown in FIGS. 6A and 6B
maintains the pouch 100 encased implantable pulse generator 2 in a
fixed relationship with respect to the fixation rod 4 to which it
is attached.
[0068] FIGS. 1A through 6B relate to implantation and fixation of
the implantable pulse generator 2 using a pouch 100 for encasing
the implantable pulse generator 2 and one or more attachment
elements or surfaces for fixating the pouch 100 encased implantable
pulse generator 2 within a patient's anatomy.
[0069] FIGS. 7-9 relate to lead placement and fixation in a patient
anatomy.
[0070] FIGS. 7A-7C illustrate a lead placement tool 200. The lead
placement tool 200 comprises first and second end regions, 202, 204
and a central region 206 extending therebetween, and a top surface
T and a bottom surface B extending along first and second regions
202, 204 and central region 206. The first end region 202 of the
lead placement tool 11 may have an angle .alpha., as shown about a
90-degree bend, with respect to the central portion 206 of the tool
200. The first end region 202 of the lead placement tool 200 may
comprise a portion that is curved to create a groove or channel 208
that is open for slideably receiving a lead 6 therein. The first
end 202 of the lead placement tool 200 further has a bottom surface
B for slideably advancing and retracting the lead placement tool
200 against a bone or other anatomical space. FIG. 7C shows an
exemplary groove or channel 208 with electrical lead received
therein. As will be discussed below, first or second regions 202,
204 may be straight, without a bend relative to the central region
106.
[0071] As shown, and in all embodiments, the first and second
regions, 202, 204 and the central region 206 of the lead placement
tool 200 all extend along a common longitudinal plane, whether
angles exist or not. In other words, the first and second regions
202, 204 and the central region 206 are collinear and coplanar.
[0072] The groove or channel 208 may be provided alone one or both
of first and second end regions 202, 204. Further, the groove or
channel 208 may be disposed so that is it open along the top
surface of one or both of first and second end regions 202, 204
and/or open along the bottom surface of one or both of first and
second end regions 202, 204.
[0073] As shown in more detail in FIG. 7B, the first end region 202
of the lead placement tool 202 is positioned in an anatomical space
such that the bottom surface B of the lead placement tool 200
interfaces with the bone and the top surface of the first end
region of the tool 200 provides the open groove or channel 208 for
slideably advancing the lead 6 for placement at an anatomical site
such as the dorsal root ganglia or in therapeutic proximity to the
dorsal root ganglia or other nerve target. Once the lead 6 has been
placed in therapeutic proximity to the dorsal root ganglia or other
nerve target, the lead placement tool 200 can then be slideably
retracted, leaving the lead 6 in place.
[0074] The second end region of the lead placement tool 11, as
shown in FIG. 7A, may have an angle .beta. with respect to the axis
of the central region 206 of the tool 200, creating an exemplary
angle of about 45 degrees between the second end region 204 and the
central region 206. The second end region of the tool 11 may have a
curved open portion creating a groove or channel 208 similar to
that of the first end region 202. The groove or channel 208 when
present in either first or second end regions 202, 204 may be
formed along the top surface T of tool 200, the bottom surface B of
tool 200. The first end region 202 may comprise the groove or
channel 208 along its top surface T or its bottom surface B and the
second end region 204 may comprise the groove or channel 208 along
its top surface or its bottom surface B.
[0075] In all cases, the surface of the tool 200 that is opposite
of the open groove or channel 208 is curved, closed and relatively
smooth to allow that portion of the tool 200 to slide along bone or
other anatomical structure.
[0076] In some cases only a single angle and groove or channel 208
may be provided. In other embodiments, two angles and two grooves
or channels 208 are provided.
[0077] The second end region 204 of the tool 200 functions in the
same manner as described above with respect to the first end of the
tool 200. The angles .alpha. and .beta. may be the same or they may
differ. Depending on patient anatomy and/or the preference of the
physician performing the lead placement procedure, the first end
region 202 or the second end region 204 of the tool 200 may be the
more preferable and/or more effective guide for lead placement in a
given procedure or procedure step.
[0078] It is intended that the 90-degree bend and 45-degree bend
described with respect to the first end region 202 and second end
region 204, respectively, are merely exemplary, and that many
different bend angles are contemplated in accordance with the
present invention even extending as far as a straight tool with a
zero-degree bend, and including a shallow bend tool 200 with at
least one end region having a less than 45-degree bend with respect
to the axis of the central region 206 of the tool 200
[0079] FIGS. 7D-7G illustrate an alternative embodiment of a lead
placement tool 200. The tool 11 has opposing first and second end
regions 202, 204 and a central region 206 extending therebetween.
The first end region 202 of the lead placement tool 200 comprises
angle .alpha. that is shown about a 90-degree bend with respect to
the central region 200 of the tool 200.
[0080] The first and second end regions 202, 204 of the lead
placement tool 200 has top surface T curved to create a groove or
open channel 208 for slideably receiving a lead 6 therein. As
noted, alternative embodiments may comprise groove or open channel
208 formed along the bottom surface B of tool 200.
[0081] As best shown in FIGS. 7E-7G, open channel 208 may extend
beyond either the first end or second end regions 202, 204 and may
extend along a top T or bottom B surface of the central region 206
in certain embodiments.
[0082] Returning to FIGS. 7D-7G, once the lead 6 has been placed in
therapeutic proximity to the dorsal root ganglia or other nerve
target, the lead placement tool 200 can then be slideably
retracted, leaving the lead 6 in place at or near the nerve
target.
[0083] Depending on patient anatomy and/or the preference of the
physician performing the lead placement procedure, the first end or
the second end regions 202, 204 of the lead placement tool 200 may
be the more preferable and/or more effective guide for lead
placement in a given procedure or procedure step. It is intended
that the illustrated 90-degree bend and 45-degree bend for angles
.alpha. and/or .beta. are merely exemplary, and that many different
bend angles are contemplated in accordance with the present
invention even extending as far as a straight tool 200 with a
zero-degree angle between the first or second end region and the
central region, and further includes a shallow angle embodiment
with at least one of the first or second regions having a less than
45-degree bend with respect to central region of the tool 200.
[0084] FIG. 8 illustrates a lead harness 300 having a first side
for receiving one a portion of one or more leads 6 thereon. The
lead harness 300 is flexibly foldable such that the first side
forms a channel for slideably maintaining the portion of the leads
6 therein. The second side of the lead harness 12 forms a
protective cover over the portion of the leads 6 maintained within
the channel formed by the first side.
[0085] The harness 300 further includes an attachment member 9
having a first end connected to and extending from the harness 300
and a second end extending to and connectable to an anchor
location. The anchor location may be a fixation rod 4 as shown in
FIG. 8 or may be a bone or tissue or a pedicle screw 5 or any other
element that would be sufficient to maintain position of the
attachment member 9. The attachment member 9 may be a flexible
material such that it forms a tethered relationship between the
anchor location and the harness 300, providing some degree of
movement to the harness 300 but only within a tethered area defined
by the attachment element 9.
[0086] The second end of the attachment member 9 may be connected
to the fixation rod 4 by wrapping the second end of the attachment
member 9 around the fixation rod 4 and/or tying the second end to
the fixation rod 4. Any number of attachment mechanisms may be used
in combination with the attachment member 9 to connect the
attachment member 9 to an anchor site include a suture, a twist
tie, a gripper, a coil and other such attachment mechanisms.
[0087] The harness 300 provides the advantage of maintaining the
placement and positioning of the leads 6 with respect to each other
without providing a gripping force that could be damaging to the
lead body and that could potentially lead to loss of performance or
functionality of the lead 6.
[0088] The harness 300 and harness attachment member 9 in
combination with the pouch 100 and pouch attachment member 9, and
the various embodiments of these, provide a means for maintaining
the positioning of the implantable pulse generator 2 and the leads
6 in anatomical positions that allow for the ongoing delivery of
neuromodulation therapy.
[0089] FIGS. 9A and 9B provide example embodiments of the lead
placement and lead harness 12 of a neuromodulation system implanted
in a patient anatomy in accordance with the present invention.
[0090] FIG. 9A shows a series of leads 6 placed such that a distal
end of each lead is positioned in therapeutic proximity to a
corresponding dorsal root ganglion, each lead 6 at a different
nerve level. The proximal end of each lead 6 converges such that
the proximal end of each lead 6 is received in the lead harness 300
resulting in a unilateral arrangement of the leads 6 and lead
harness 300.
[0091] FIG. 9B illustrates a bilateral arrangement of leads 6 and
corresponding lead harnesses 300. A first set of leads 6 each have
distal ends on a single side of a patient spine 7, each lead 6
being placed at a different nerve level in therapeutic proximity to
a corresponding dorsal root ganglia. The proximal portions of the
first set of leads 6 cross the spinal axis and converge to enter a
lead harness 300 on the opposite side of the spinal axis A. A
second set of leads 6 is in a mirrored relationship to the first
set of leads 6, each of the second set of leads 6 having a distal
end positioned at a different nerve level, placed in therapeutic
proximity to a corresponding dorsal root ganglia. The proximal end
of each of the second set of leads 6 crossing the spinal axis A and
converging to enter a lead harness 300 on the opposite side of the
spinal axis A. This bilateral arrangement of lead placement with
respect to lead harness 300 positioning may provide additional lead
placement stability by minimizing the bending forces on the distal
ends of the lead 6 while the harness 300 provides additional lead
fixation support.
[0092] Both FIGS. 9A and 9B provide the lead placement and a spinal
fixation device with fixation rods 4 and pedicle screws 5.
[0093] FIGS. 10A-10B are fluoroscopic images of leads 200 implanted
at a spinal treatment site in combination with a spinal fixation
implant. FIG. 10A shows a spinal treatment site where the spinous
process bones have been removed during implant of the spinal
fixation device. The leads 6 were delivered from a medial (over the
spinal cord dura) to lateral pathway approach through to the spinal
foramen and the treatment site at the DRG. As shown, the leads 6
enter medially and then flare out to opposing first or second
lateral sides, loop around a portion of the spinal fixation device
and extend to a neuromodulation target at an opposite first or
second lateral side of the treatment site such that each lead 6 is
in therapeutic proximity to a corresponding dorsal root ganglia. By
way of example, lead enters medially and extends to a first lateral
side L1, loops around a portion of the spinal fixation device on
the first lateral side L1 and then crosses to the opposing second
lateral side L2 for placement in therapeutic proximity to the
target dorsal root ganglia.
[0094] FIG. 10B shows a spinal treatment site where the bone has
been removed during implant of the spinal fixation device. The
leads extend from a single unilateral approach at a spinal level
below the fixation device. The leads are then placed along a
pathway 301, 302, 303 such that leads placed on unilateral approach
side are curved around an opposing lateral side of the fixation
device and back across the spinal treatment site to a corresponding
target dorsal root ganglia. The leads placed on the opposing
lateral side are curved around a portion of the fixation device on
the unilateral approach side before extending laterally to the
opposing lateral side via pathway 401, 402.
[0095] The lead placement tool 200 described herein can be used, by
way of example, for placement and anchoring of leads in accordance
with the lead pathways shown in FIGS. 10A-10B and with any other
such lead pathway as determined by such factors that may include
but are not limited to patient anatomy, bone structure, whether
bone has been removed, physician preference, lead properties,
position of the implantable pulse generator and other
considerations.
[0096] The lead harness 300 can be used, by way of example, at the
location where a single lead may require anchoring to ensure that a
therapeutic relationship is maintained between the lead and the
target nerve. The lead harness 300 may additionally be used, by way
of example but not limiting other uses, at a location where two or
more leads converge such as shown in FIGS. 10A-10B.
[0097] FIG. 11 illustrates an embodiment of a neuromodulation
system including an implantable pulse generator 2 and one or more
neurostimulation leads 6 coupled to the implantable pulse generator
2. The neuromodulation system 13 is implanted at a spinal treatment
site where a spinal procedure has been performed including a
decompression procedure and/or including a spinal fixation
procedure. As shown in FIG. 11, the neuromodulation system is
implantable in combination with a spinal fixation procedure
including one or more spinal fixation rods 4 secured to the spinal
treatment site by pedicle screws 5. The implantable pulse generator
2 and leads of the neuromodulation system 13 may incorporate any of
the previously described features and elements, or variations
thereof, as described above, including but not limited to a pouch
100, various attachment elements coupled to the pouch 100 to anchor
or secure the pouch-enclosed IPG, and may incorporate a lead
harness 300.
[0098] As shown in FIG. 11, the lead 6 is positioned along the
spinal cord to provide a neurostimulation signal to the spinal
cord. The lead 6 extends from the spinal treatment site at a
portion of the spinal treatment site where the spinal cord was
exposed during a spinal treatment procedure. The lead 6 is
positioned along a lead pathway that extends to at least a portion
of the thoracic spine, under the intact spinous process of the
portion of the thoracic spine. The lead 6 may be incorporate a
spinal cord stimulation paddle lead design having one or more
programmable electrodes for optimization of spinal cord
stimulation.
[0099] Although not shown in FIG. 11, one or more leads 6 may
additionally extend from the implantable pulse generator 2 to one
or more target dorsal root ganglia in accordance with the various
lead pathways previously described above.
[0100] Another method for implanting a neuromodulation system
incorporated herein is a lateral approach to neurostimulation.
Neuromodulation and delivering electrical or other forms of energy
have been typically performed from the dorsal aspect of the spinal
cord. Another approach has been through the neuroforamena and the
dorsal root ganglion.
[0101] There are many pathways including but not limited to
spinothalamic tract that run in the anterolateral and anterior part
of the spinal cord. These nerve fibers and tracts carry a variety
of information including pain signals to more central locations and
the brain. Performing spinal cord stimulation from a lateral and/or
anterolateral and anterior approach has been anatomically and
practically challenging. Current lead designs and placement
techniques may also cause sensation of pain by the patient.
[0102] The improved method for lateral placement of a lead 6
incorporates a lead 6 that will be placed in the lateral and/or
anterolateral and/or anterior part of the epidural space in the
thoracic and/or lumbar and/or cervical region to deliver electrical
energy using a variety of frequencies including but not limited to
high frequencies and a variety of complex stimulation patterns.
[0103] Other modes of neuro-modulation including pulsed
radiofrequency, cooling or gentle heat may also be applied with
this approach. The electrode/electrodes may also collect a variety
of data and biometrics as well as delivering energy. For example
cordotomy has been used in extreme refractory cases of cancer pain
in the past. It includes lesioning the spinothalamic tract which
produces pain relief with significant side effects, namely
dysesthesias, apnoea and urinary retention. Placing an anterior
lead could be an attempt to modulate and not destroy these nerve
fibers and achieve the relief without these serious side
effects.
[0104] The description of the invention and is as set forth herein
is illustrative and is not intended to limit the scope of the
invention. Features of various embodiments may be combined with
other embodiments within the contemplation of this invention.
Variations and modifications of the embodiments disclosed herein
are possible and practical alternatives to and equivalents of the
various elements of the embodiments would be understood to those of
ordinary skill in the art upon study of this patent document. These
and other variations and modifications of the embodiments disclosed
herein may be made without departing from the scope and spirit of
the invention.
* * * * *