U.S. patent application number 16/446285 was filed with the patent office on 2019-10-31 for method and apparatus for minimally invasive posterolateral spinal fusion.
The applicant listed for this patent is Quandary Medical, LLC. Invention is credited to Ryan Alexander Arce, Brandon B. Arthurs, David C. Eyvazzadeh, Leighton Joseph LaPierre, Scott Noble, Yuta Okkotsu, Gerald R. Schell, Jeffrey R. Schell.
Application Number | 20190328405 16/446285 |
Document ID | / |
Family ID | 60482490 |
Filed Date | 2019-10-31 |
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United States Patent
Application |
20190328405 |
Kind Code |
A1 |
LaPierre; Leighton Joseph ;
et al. |
October 31, 2019 |
METHOD AND APPARATUS FOR MINIMALLY INVASIVE POSTEROLATERAL SPINAL
FUSION
Abstract
Certain embodiments of the invention relate to a surgical
procedure resulting in the fusion of transverse processes. The
disclosure herein presents novel approaches for accessing
transverse processes of the spine, novel methods for the delivery
of fusion material for the fusion of said transverse processes, and
novel tools to facilitate the procedure. Certain embodiments of the
invention include a graft delivery assembly, which has a delivery
shaft, delivery sheath, and at least one curved rod. Bony material
is position with a graft delivery assembly, in which retraction of
the delivery shaft or sheath places the bone fusion material to the
fusion site. The graft delivery assembly further includes features
to decorticate and prepare the bone surface for fusion.
Inventors: |
LaPierre; Leighton Joseph;
(Thornton, CO) ; Noble; Scott; (Denver, CO)
; Arce; Ryan Alexander; (Denver, CO) ; Schell;
Jeffrey R.; (Denver, CO) ; Okkotsu; Yuta;
(Aurora, CO) ; Eyvazzadeh; David C.; (Denver,
CO) ; Arthurs; Brandon B.; (Wilmington, NC) ;
Schell; Gerald R.; (Bay City, MI) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Quandary Medical, LLC |
Denver |
CO |
US |
|
|
Family ID: |
60482490 |
Appl. No.: |
16/446285 |
Filed: |
June 19, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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15612781 |
Jun 2, 2017 |
10368881 |
|
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16446285 |
|
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62345667 |
Jun 3, 2016 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/1671 20130101;
A61B 17/1635 20130101; A61B 17/7061 20130101; A61B 2017/32006
20130101; A61B 2017/320052 20130101; A61B 17/3421 20130101; A61B
17/1757 20130101; A61B 17/7089 20130101 |
International
Class: |
A61B 17/16 20060101
A61B017/16; A61B 17/70 20060101 A61B017/70; A61B 17/17 20060101
A61B017/17; A61B 17/34 20060101 A61B017/34 |
Claims
1. A medical device assembly for delivering bone graft, comprising:
a delivery shaft, said delivery shaft having a tool insertion end
and a graft delivery end, said delivery shaft aligned with a
central axis, said central axis defining a shaft pathway extending
between said tool insertion end and said graft delivery end, said
delivery shaft further comprising a handle, said delivery shaft
further comprising a retention lock; and a first element having a
first end, a second end, and an exterior surface, said first
element aligned with said central axis, said first element being
axially slidable through said shaft pathway, said first element
further comprising a handle, wherein said delivery shaft retention
lock is adapted to retain said first element from sliding.
2. The assembly of claim 1, said delivery shaft further comprising
a slot, said slot in communication with said delivery shaft
pathway, and wherein said first element handle is a jut protruding
from said first element exterior surface, said jut correspondingly
passing through said slot and extending past the delivery shaft
exterior surface.
3. The assembly of claim 2, wherein said slot further comprises a
slot end.
4. The assembly of claim 1 further comprising a second element;
said first element further comprising a pathway extending between
said first end and said second end, and defining a hollow form with
an interior surface; said second element having a first end, a
second end, and an exterior surface, said second element being
axially slidable through said first element pathway; and said
delivery shaft further comprising a second retention lock adapted
to retain said second element from sliding.
5. The assembly of claim 4, said second element comprising a mating
feature, said mating feature engageable with said second retention
lock.
6. The assembly of claim 4, said second element further comprising
an abrading surface.
7. The assembly of claim 4, said second element second end further
comprising a beveled end configured to create a pathway through
tissue.
8. The assembly in claim 1, said retention lock further comprising
a retention latch defined by a collar portion rotatable about said
shaft central axis, and a latch portion being able to restrict the
slideable movement of said first element.
9. The assembly of claim 1, said first element further comprising
an abrading surface.
10. The assembly of claim 1, said first element second end further
comprising a beveled end configured to create a pathway through
tissue.
11. A medical device assembly for delivering bone graft,
comprising: a delivery shaft, said delivery shaft having a tool
insertion end and a graft delivery end, said delivery shaft aligned
with a central axis, said central axis defining a shaft pathway
extending between said tool insertion end and said graft delivery
end, said delivery shaft further comprising a handle; a first
element having a first end, a second end, and an exterior surface,
said first element aligned with said central axis, said first
element being axially slidable through said shaft pathway, said
first element further comprising a pathway extending between said
first end and said second end, and defining a hollow form with an
interior surface; said first element further comprising a handle;
and a second element having a first end, a second end, and an
exterior surface, said second element being axially slidable
through said first element pathway.
12. The assembly of claim 11, wherein said delivery shaft further
comprises a retention lock, wherein said delivery shaft retention
lock prevents said first element from sliding.
13. The assembly in claim 12, wherein said retention lock comprises
a retention latch defined by a collar portion rotatable about said
delivery shaft central axis, and a latch portion restricting
slideable movement of said first element when said retention latch
is positioned in a locking position.
14. The assembly in claim 12, wherein said delivery shaft further
comprises a second retention lock wherein said delivery shaft
second retention lock prevents said second element from
sliding.
15. The assembly of claim 11, said delivery shaft further
comprising a slot, said slot in communication with said delivery
shaft pathway, and wherein said first element handle is a jut
protruding from said first element exterior surface, said jut
correspondingly passing through said slot and extending past the
delivery shaft exterior surface.
16. A method of placing bony material between adjacent transverse
processes, comprising: making an incision in the skin on the
posterior side of a patient offset from the medial plane and in
proximity to a transverse process; creating a pathway to a first
transverse process through said incision with an assembly, the
assembly comprising: a delivery shaft, said delivery shaft having a
tool insertion end and a graft delivery end, said delivery shaft
aligned with a central axis, said central axis defining a shaft
pathway extending between said tool insertion end and said graft
delivery end, said delivery shaft further comprising a handle, said
delivery shaft further comprising a retention lock; and a first
element having a first end, a second end, and an exterior surface,
said first element aligned with said central axis, said first
element being axially slidable through said shaft pathway, said
first element further comprising a handle, wherein said delivery
shaft retention lock is adapted to retain said first element from
sliding; extending said pathway to at least a second transverse
process adjacent to said first transverse process with said
assembly; and dispensing bony material through said pathway
depositing bony material between said first transverse process and
said second transverse process.
17. The method in claim 16, further comprising: decorticating the
posterior surface of said first transverse process and said at
least second transverse process through said pathway, wherein said
assembly further comprises an ablating surface configured for
decorticating said transverse processes.
18. The method in claim 16, further comprising: pre-loading said
assembly with bony material and dispensing said bony material
between said first transverse process and said at least second
transverse process.
19. The method of claim 16, said delivery shaft further comprising
a slot, said slot in communication with said delivery shaft
pathway, and wherein said first element handle is a jut protruding
from said first element exterior surface, said jut correspondingly
passing through said slot and extending past the delivery shaft
exterior surface.
20. The method of claim 16 wherein the assembly further comprises a
second element having a first end, a second end, and an exterior
surface, said second element being axially slidable through said
first element pathway, said first element further comprising a
pathway extending between said first end and said second end, and
defining a hollow form with an interior surface, and said delivery
shaft further comprising a second retention lock adapted to retain
said second element from sliding.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation application of U.S.
patent application Ser. 15/612,781, filed on Jun. 2, 2017, which
claims the benefit of U.S. Provisional Patent Application
62/345,667, filed on Jun. 3, 2016, which is hereby incorporated by
reference.
BACKGROUND OF THE INVENTION
[0002] For the thoracic vertebrae and lumbar vertebrae, a portion
of the transverse processes, lamina, pedicles, and vertebral body
form a structure called the spinal canal, which protects the spinal
nerve. Instability in the spine, such as in the case of
spondylolisthesis, can cause nerve irritation and lead to back
pain, leg pain, and motor defects. Pain associated with instability
in the spine is commonly treated with fusion of adjacent vertebrae.
Since the early descriptions of spinal fusions in the early
20.sup.th century, advances in spine surgery techniques and devices
have allowed more targeted, and less invasive approaches (Albee.
1911. Transplantation of a portion of the tibia into the spine for
Pott's disease. A preliminary report. JAMA. 57:885; and Hibbs.
1912. A further consideration of an operation for Pott's disease of
the spine: with report of cases from the service of the New York
orthopaedic hospital. Ann. Surg. 55:682.).
[0003] Each vertebra has two laterally located structures called
transverse processes. A transverse process serves as an attachment
point for a number of ligaments and muscle fibers, including, for
example, the longissimus muscles, multifidus muscles, rotatores
muscles, and levatores costarum muscles. Transverse processes found
at the thoracic vertebrae further contain articular facets that are
connected to, and serve as attachment points to tubercles of ribs.
Using adjacently located transverse processes to place bony
material has been described previously.
[0004] Traditional lateral intertransverse process fusion, or more
commonly referred to as posterolateral fusion procedures or gutter
fusion, commonly involves placing bony material along two or more
transverse processes of adjacently located vertebrae. There are
potential benefits of fusing adjacently located transverse
processes to stabilize the spine. Typically, after a period of 6 to
12 months post-surgery, patients undergoing intertransverse process
fusion have higher rates of fusion than patients whose spine are
secured with screws and rods alone. Such fusion process has been
described to consistently have higher fusion rates compared to some
other interbody fusion approaches, such as posterior lumbar
interbody fusion (PLIF) (Inamdar, et al. 2006. Posterior lumbar
interbody fusion versus intertransverse fusion in the treatment of
lumbar spondylolisthesis. J. Ortho. Surg. 14:21). A typical problem
associated with gutter fusions known in the prior art is that such
techniques require new or existing (as combined with other surgical
procedures) large incisions to perform, incisions which surgeons
trained in newer, minimally invasive techniques typically seek to
avoid. An unmet need therefore exists to develop instrumentation
and tools to allow for a less invasive posterolateral gutter fusion
procedure.
[0005] Traditional posterolateral fusion procedures, while
generally efficacious, have several disadvantages. For instance, in
traditional posterolateral fusion procedures, it is common to make
a relatively large incision in the posterior region of a patient's
back to access and place bony material on and/or between adjacently
located transverse processes. Such typical posterolateral fusion
procedures can cause great trauma to surrounding tissue and muscle,
as such a procedure as known in the prior art involves creating a
relatively wide incision to allow access to the transverse process
for the placement of bony material. Often, access to transverse
processes involves creating a relatively large incision that is
approximately 6 inches (15 cm) to 12 inches (30 cm) or more. During
creation of such opening to access adjacently located transverse
processes, muscle fibers in the vicinity are pulled, split, and
tucked. In some cases, muscle fibers are unintentionally, or
unavoidably cut. There is also a possibility that blood vessels are
cut during such typical posterolateral fusion procedures, leading
to the undesirable consequences of interrupted blood supply,
possibly slower healing, and a high level of blood loss. The
vascularity of the operative area makes traditional posterolateral
fusion procedures a procedure associated with a potentially high
level of complications (Truchly and Thompson. 1962. Posterolateral
Fusion of the Lumbosacral Spine. J. Bone and Joint Surg. 44-A:505).
In some cases, there is a risk of injury to nerves with such large
incisions, resulting in nerve damage, decreased sensation during
and after surgery, and high levels of post-surgical pain.
[0006] In typical posterolateral fusion procedures, once bony
material is laid between transverse processes, there is difficulty
in keeping bony material in the correct place. Due to the large
incision to access the transverse processes, during healing, such
bony material may shift or move to other unintended areas. Further,
bony material may be placed further anterior, beyond the transverse
processes due to, for example, surgeon error and suboptimal
surgical technique and instrumentation.
BRIEF SUMMARY OF CERTAIN EMBODIMENTS OF THE INVENTION
[0007] Certain embodiments of the invention relate to a minimally
invasive surgical procedure to facilitate the fusion of transverse
processes. The disclosure herein presents novel approaches for
accessing transverse processes of the spine, novel methods for the
delivery of fusion material to aid the fusion of said transverse
processes, and novel tools to facilitate the procedure in a
minimally invasive manner. Certain embodiments of the invention
incorporate improved methods for access and treatment, providing a
generally less invasive and more efficient procedure than existing
surgical methods for fusion of two or more spinal vertebrae at or
near the transverse processes. It will be appreciated to those
skilled in the art that surgical procedures providing methods that
are intended to minimize collateral trauma to tissue and systems of
the patient, are generally referred to as "minimally invasive"
procedures.
[0008] It will be appreciated that embodiments of the invention are
performed through a relatively small incision. Access to the
transverse process through a small incision allows the surgeon to
cause less trauma during the approach. Such access is less invasive
and reduces potential damage to muscles or nerves in the vicinity
of the spine. Certain embodiments of the invention relate to
methods for adding bony material along two or more transverse
processes of adjacent vertebrae. In certain embodiments, the
methods and apparatuses related to the placement of such bony
material in a minimally invasive fashion are novel improvements
upon previously known posterolateral fusion procedures.
[0009] Certain embodiments are designed for use in conjunction with
other spinal fusion procedures. The present inventors have
recognized that placement of bony material on the posterior side of
the transverse processes often results in better fusion of the
vertebrae when combined, for example, with screw and rod systems
and/or interbody implants. Certain embodiments include a system,
method, or apparatus that facilitate the placement of bony material
for fusion of transverse processes. Due to the minimally invasive
nature of embodiments of the system and instruments described
herein, the procedures can be performed through the same incision
or incisions similar to those used for other minimally invasive
procedures, such as for example the incision used for the placement
of a posterior fixation system, such as a minimally invasive
pedicle screw and rod construct. It will be appreciated by those
skilled in the art that the fusion of two or more adjacent
transverse processes is referred to as an intertransverse process
spinal fusion.
[0010] Certain embodiments of the invention include access to one
or more transverse processes through a posterior-lateral approach,
decortication of the one or more transverse processes, further
expansion of the path between the one or more transverse processes,
and closure of the incision. Certain embodiments include access to
the transverse process using an instrument comprising a curved end
to access a portion of one or more transverse processes. Certain
embodiments include features for decorticating the transverse
processes. Additionally, certain embodiments include features for
delivery of the bony material.
[0011] In certain embodiment of the invention, a graft delivery
assembly or tool includes a decorticating surface to decorticate
one or more transverse processes in a minimally invasive manner. In
certain embodiments, graft delivery assembly is used for
decorticating a surface that is perpendicular or near perpendicular
to the path of entry. Certain embodiments include a curved element
having an abrading surface deployed against a transverse process,
where a back-forth motion or rotation of the assembly along its
central axis allows bone decortication.
[0012] In certain embodiments, a decortication feature accesses and
decorticates a surface of a transverse process at an approach angle
that is substantially perpendicular. In certain embodiments, an
angled tool assembly is used to decorticate a transverse process
through an approach path that is not perpendicular (i.e.,
90.degree. or less).
[0013] Certain embodiments include using a distending feature to
place bony material in the space between the transverse processes.
In certain embodiments, one end of a distending device associated
with the invention is filled with bony material. In such a device,
the distending device subsequently deposits bony material between
at least a first transverse process and a second transverse process
during the associated surgical procedure.
[0014] In certain embodiments, the surgical approach to accomplish
placement of bony material across and between adjacent transverse
processes is accomplished through a generally curved pathway. In
certain embodiments, the space between transverse processes is
first accessed with a curved needle. In other embodiments of the
invention, the apparatuses allow for the procedure to take place
without first placing a needle to define the path. In certain
embodiments dilators matching the diameter of such curved needle
expand a pathway to the transverse processes.
[0015] Certain embodiments incorporate steps to define an access
portal by way of associated instrumentation. A user may generally
insert instruments, devices, tools, bony material, and the like
through an access portal or a dilator. In certain embodiments,
decortication tools, including, but not limited to a cutter
assembly, rasps, files, and drills are used to decorticate the
surface of the transverse processes through an access portal or a
dilator. Furthermore, in certain embodiments, bony material is
deposited between transverse processes through a generally curved
pathway.
[0016] In certain embodiments, bony material is delivered to at
least a first transverse process, an intertransverse space, and a
second transverse process using a graft delivery assembly or tool.
In certain embodiments, a graft delivery assembly or tool itself is
used to create a path to the transverse process through an
incision. In certain embodiments, a graft delivery assembly or tool
is used to deliver bony material on at least one transverse process
surface. In certain embodiments, a graft delivery assembly or tool
incorporates a rasp-like feature on the side intended to directly
contact the transverse process to decorticate the bone surface of
one or more transverse processes. Certain embodiments use a graft
delivery tool to open a path and deliver bony material to a
surgical site. Certain embodiments of a graft delivery tool include
a handle, a first segment, and a second segment. In certain
embodiments, a graft delivery tool having a solid profile may be
used by a practitioner to create a pathway from the exterior of the
body to the transverse processes through an incision of the skin.
In certain use cases, a graft delivery tool having a solid profile
may be inserted to create a pathway to the intertransverse space
after performing a pedicle screw/rod fixation procedure, optionally
through the same incision used for the pedicle screw/rod fixation
procedure. Certain embodiments allow placement of bony material
across two or more transverse processes. In certain embodiments, a
graft delivery tool has an abrading surface that allows
decortication of a bone surface.
[0017] In certain embodiments, a graft delivery assembly or tool
may have pre-loaded bony material. Pre-loaded bony material may be
placed within the graft delivery assembly or tool prior to the step
utilizing the graft delivery tool during the surgical procedure.
The graft delivery assembly or tool containing pre-loaded bony
material may be subsequently inserted through a minimally invasive
incision and then along a path that allows for placement of the
pre-loaded bony material in proximity or in contact with two or
more adjacent transverses processes. In an embodiment of the graft
delivery assembly tool, a shaft or sheath may be retracted back
through the pathway while the plunger of the embodiment forces the
bony material outward, depositing the bony material across and
between the at least two transverse processes as the graft delivery
assembly or tool retracts. In embodiments of the graft delivery
assembly or a plunger stays in a generally stationary position
while the user of the embodiment retracts the shaft or sheath using
a trigger-like handle over the plunger to deposit the bony
material. In certain embodiments, a graft delivery assembly or tool
with a hollow profile has a ratcheting device. In certain
embodiments, a graft delivery tool with hollow profile comprises a
thumb-wheel device further comprising a thumb-wheel. A user may
rotate the thumb-wheel in a first direction to extend a plunger
head in a distal direction to dispense loaded bony material in a
second direction to retract the plunger head in a proximal
direction. In certain embodiments, a graft delivery tool with a
hollow profile incorporates an outer sleeve that is connected to a
sleeve handle, which a surgeon may utilize to pull back the outer
sleeve and thereby deposit bony material after retraction. The
retraction of the plunger head may be desired to allow a
practitioner to load bony material into the graft delivery tool for
successive bony material depositions.
[0018] Certain embodiments of the invention include a graft
delivery assembly, which further includes a graft delivery shaft
and a curved element. A curved element may come in the form of a
sheath or a rod. Certain embodiments of the invention include a
graft delivery assembly, which further includes a delivery shaft,
delivery sheath, and at least one curved rod. Certain embodiments
of a delivery shaft have a tool insertion end and a graft delivery
end. A delivery shaft generally follows a central axis, and further
has a shaft pathway that follows the central axis, and is
communicably connects the tool insertion end and a graft delivery
end. In certain embodiments, a central axis includes a curvature,
where generally, the curvature closely aligns with the lordotic
curvature of certain regions of the spine. The shaft pathway
generally allows passage of other instruments, such as curved
elements including a delivery sheath and a curved rod, bony
material, or other objects described herein or elsewhere relevant
to surgical procedures.
[0019] Certain embodiments of a graft delivery shaft include a
small longitudinal opening that communicates with the shaft
pathway. Such small longitudinal opening slideably guides a
protrusion or a jut (such jut being able to work as a handle) of a
delivery sheath or a curved rod. Certain embodiments of a delivery
shaft also include a handle for easier handling. Certain
embodiments of a delivery shaft also include ventilation holes
allowing sterilization of the assembly. In certain embodiments, a
delivery shaft is a unibody assembly, or two-mating pieces
assembled and optionally fastened with fasteners to allow easier
assembly.
[0020] In certain embodiments, a delivery shaft includes a
retention lock that restricts movement of either a delivery sheath
or a curved rod relative to the delivery shaft. In certain
embodiments, a retention lock has a mechanism to restrict movement
of an instrument (including delivery sheath, curved rod, or other
instruments) from sliding through a shaft pathway. In certain
embodiments, a retention lock includes a 90.degree., radially
actuated retention latch.
[0021] In certain embodiments, a graft delivery assembly includes a
curved element, such as a sheath. An embodiment of a sheath has a
first end and second end, with a sheath pathway generally following
the central axis and being in communication with the first end and
second end. The sheath pathway generally allows passage of other
instruments, curved elements, and the like, such as curved rod,
bony material, or other objects described herein or elsewhere
relevant to surgical procedures. In certain embodiments, the sheath
pathway further defines an exterior surface and an interior
surface. The delivery sheath exterior surface has a protrusion or
jut in certain embodiments. When installed in a delivery shaft, the
delivery sheath slides through the shaft pathway.
[0022] Embodiments of a graft delivery assembly also include a
curved element such as a curved rod. In certain embodiments, a
curved rod is further defined as a decorticating rod and/or as a
plunging rod. A curved rod is generally aligned with a central
axis, and is further defined by a first end and a second end.
Certain embodiments of a decorticating rod have an abrading surface
allowing decortication of bone surfaces. Certain embodiments of a
curved rod have beveled end, allowing separation of tissue in an
atraumatic fashion as the assembly is inserted into the body. In
certain embodiments, a plunging rod has a surface that allows
pushing bone graft to the surgical site. In one example, a curved
rod has a blunt end. Together, by controlling the timing of the
locking and unlocking of the retention locks, the graft delivery
assembly in certain embodiments allows for targeted delivery of
graft material to the transverse processes.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] FIG. 1. A flow diagram of steps to fuse adjacently located
vertebrae in certain embodiments of the invention.
[0024] FIG. 2A. A flow diagram of specific exemplary steps to fuse
adjacently located vertebrae in certain embodiments of the
invention.
[0025] FIG. 2B. A flow diagram of specific exemplary steps to fuse
adjacently located vertebrae in certain embodiments of the
invention.
[0026] FIG. 3. A lateral view of an exemplary spine.
[0027] FIG. 4. A posterior view of an exemplary spine, including
the lumbar vertebrae and sacrum.
[0028] FIG. 5. Superior-Posterolateral view of an exemplary spine,
including the lumbar vertebrae and sacrum.
[0029] FIG. 6A. A lateral view of an exemplary spine.
[0030] FIG. 6B. A lateral view of an exemplary spine showing an
approach path for fusion of a right transverse process of L3 and
right transverse process of L4 in certain embodiments of the
invention.
[0031] FIG. 7A. A lateral view of an exemplary spine showing an
approach path for fusion of a right transverse process of L2 and
right transverse process of L3 in certain embodiments of the
invention.
[0032] FIG. 7B. A lateral view of an exemplary spine showing an
approach path for fusion of a right transverse process of L4 and
right transverse process of L5 in certain embodiments of the
invention.
[0033] FIG. 8. A lateral, perspective view of a patient with a
portion of a spine shown to demonstrate a radio-dense object placed
on an exterior surface of a patient's spine, and predicting a
straight line from such radio-dense object to a transverse process,
in steps in certain embodiments of the invention.
[0034] FIG. 9. A perspective view of a patient with incisions
corresponding to steps in certain embodiments of the invention.
[0035] FIG. 10. A lateral, perspective view of a needle insertion,
corresponding to certain steps in embodiments of the invention.
[0036] FIG. 11. A lateral, perspective view of a patient with a
portion of a spine shown, to demonstrate a needle advanced towards
a transverse process, in steps in certain embodiments of the
invention.
[0037] FIG. 12. A lateral, perspective view of a patient with a
portion of a spine shown, to demonstrate a guide wire advanced
through a needle, in steps in certain embodiments of the
invention.
[0038] FIG. 13A. A lateral, perspective view of a patient with a
portion of a spine shown, to demonstrate a dilator following a
guide wire, in steps in certain embodiments of the invention.
[0039] FIG. 13B. A lateral, perspective view of a patient with a
portion of a spine shown, to demonstrate a dilator advanced, in
steps in certain embodiments of the invention.
[0040] FIG. 14. A cutter assembly in certain embodiments of the
invention.
[0041] FIG. 15. A cutter blade in certain embodiments of the
invention.
[0042] FIG. 16. An angled tool assembly in certain embodiments of
the invention.
[0043] FIG. 17. An inner assembly in certain embodiments of the
invention.
[0044] FIG. 18. A cutter tool in certain embodiments of the
invention.
[0045] FIG. 19. A side view of a spine showing an embodiment of an
angled tool assembly.
[0046] FIG. 20A. A side view of an angled tool assembly in certain
embodiments.
[0047] FIG. 20B. A side view of an angled tool assembly with an
inner assembly in certain embodiments.
[0048] FIG. 20C. A side view of an angled tool assembly with an
inner assembly and a cutter tool in certain embodiments.
[0049] FIG. 21. A lateral view of a spine showing a guide wire
placed on a transverse process, and a cannula comprising a cutter
placed on an inferior transverse process.
[0050] FIG. 22. A side view showing a guide wire placed on a
transverse process, and a cannula incorporating a cutter placed on
an inferior transverse process.
[0051] FIG. 23A. A side view showing an approach path on an
inferior transverse process, and an angled tool assembly on a
superior transverse process.
[0052] FIG. 23B. A side view showing an approach path on an
inferior transverse process, and an angled tool assembly on a
superior transverse process, where a guide wire is advanced.
[0053] FIG. 23C. A side view showing an approach path on an
inferior transverse process, and an angled tool assembly on a
superior transverse process, where a flexible dilator is placed
over such guide wire.
[0054] FIG. 23D. A side view showing an approach path on an
inferior transverse process, and an angled tool assembly on a
superior transverse process, and bony material is placed in an
intertransverse process space through the flexible dilator.
[0055] FIG. 24A. A distending device is shown with a sheath closed
tightly around the tool.
[0056] FIG. 24B. A distending device is shown with dilated sheath,
allowing the passage of bony material through the sheath.
[0057] FIG. 25. A distending device is shown in an example position
as it may be used during a spinal fusion procedure, acting to
facilitate the passage of bony material to the fusion site.
[0058] FIG. 26. A distending device is shown in an example position
as it may relate to second guide wire 702b.
[0059] FIG. 27. Embodiments of a curved needle shown in relation to
a portion of a spine.
[0060] FIG. 28A. A curved needle in certain embodiments.
[0061] FIG. 28B. A curved needle and a dilator in certain
embodiments.
[0062] FIG. 28C. A curved needle and dilators in certain
embodiments.
[0063] FIG. 28D. A curved needle and dilators in certain
embodiments.
[0064] FIG. 29. A dilator in certain embodiments shown in relation
to a portion of a spine.
[0065] FIG. 30A. Top perspective view of an access portal
comprising a small longitudinal opening in certain embodiments.
[0066] FIG. 30B. Cross-sectional view of an access portal
comprising a small longitudinal opening in certain embodiments.
[0067] FIG. 31A. Cross-sectional view of a patient's back showing
an access portal and a curved needle, in certain embodiments.
[0068] FIG. 31B. Placement of a cannulated needle through an access
portal in a cross-sectional view of a patient's back, in certain
embodiments.
[0069] FIG. 31C. Placement of a guide wire through an access portal
in a cross-sectional view of a patient's back, in certain
embodiments.
[0070] FIG. 32A. Embodiments of a step where a curved needle and
guide wires are placed through a curved path, shown in a
cross-sectional view of a patient's back.
[0071] FIG. 32B. Embodiment of a step where dilators are placed
through a curved path, shown in a cross-sectional view of a
patient's back.
[0072] FIG. 33A. Embodiment of a step where a dilator is used to
deposit a bony material, shown in a cross-sectional view of a
patient's back.
[0073] FIG. 33B. Embodiment of a step where a plunger dispenses
bony material from a dilator, shown in a cross-sectional view of a
patient's back.
[0074] FIG. 33C. Embodiment of a step showing bony material being
deposited in an intervertebral space, shown in a cross-sectional
view of a patient's back.
[0075] FIG. 33D. Embodiment of a step showing bony material
deposited in an intervertebral space, shown in a cross-sectional
view of a patient's back.
[0076] FIG. 34A. Side view of an embodiment of a graft delivery
tool.
[0077] FIG. 34B. Side view of embodiments of a graft delivery tool
comprising a surface to facilitate decortication.
[0078] FIG. 34C. Side view of an embodiment of a graft delivery
tool.
[0079] FIG. 34D. A lateral view of an exemplary spine showing an
approach path for fusion of a right transverse process of L3 and
right transverse process of L4, in certain embodiments of the
invention.
[0080] FIG. 34E. A lateral view of an exemplary spine showing a
graft delivery tool spanning two adjacent transverse processes.
[0081] FIG. 34F. A lateral view of an exemplary spine showing a
graft delivery tool spanning three adjacent transverse
processes.
[0082] FIG. 35. Side view of an embodiment of a graft delivery tool
comprising a plunger.
[0083] FIG. 36A. An embodiment of a cross-section found on a graft
delivery tool.
[0084] FIG. 36B. An embodiment of a cross-section found on a graft
delivery tool.
[0085] FIG. 36C. An embodiment of a cross-section found on a graft
delivery tool.
[0086] FIG. 36D. An embodiment of a cross-section found on a graft
delivery tool.
[0087] FIG. 36E. An embodiment of a cross-section found on a graft
delivery tool.
[0088] FIG. 36F. An embodiment of a cross-section found on a graft
delivery tool.
[0089] FIG. 37A. A pointed tip found on a graft delivery tool, in
certain embodiments.
[0090] FIG. 37B. A round tip found on a graft delivery tool, in
certain embodiments.
[0091] FIG. 37C. A blunt tip found on a graft delivery tool, in
certain embodiments.
[0092] FIG. 38A. An embodiment of a graft delivery tool comprising
a surface with knurling.
[0093] FIG. 38B. An embodiment of a graft delivery tool comprising
surfaces with knurling
[0094] FIG. 38C. An embodiment of a graft delivery tool comprising
surfaces with splines.
[0095] FIG. 38D. An embodiment of a graft delivery tool comprising
knurling and splines.
[0096] FIG. 39. An embodiment of notches, in certain embodiments of
the invention.
[0097] FIG. 40. An embodiment of a graft delivery tool.
[0098] FIG. 41A. An embodiment of a graft delivery tool.
[0099] FIG. 41B. A sectional view of a graft delivery tool
embodiment.
[0100] FIG. 42. A graft delivery tool comprising a curved dilator
in certain embodiments.
[0101] FIG. 43A. A graft delivery assembly in certain
embodiments.
[0102] FIG. 43B. A graft delivery assembly in certain
embodiments.
[0103] FIG. 44A. Side view of a delivery shaft in certain
embodiments.
[0104] FIG. 44B. Perspective view of a delivery shaft in certain
embodiments.
[0105] FIG. 44C. Perspective view of a delivery shaft in certain
embodiments.
[0106] FIG. 44D. Sectional view of a delivery shaft in certain
embodiments.
[0107] FIG. 45A. Side view of a retention latch embodiment.
[0108] FIG. 45B. Perspective view of a retention latch
embodiment.
[0109] FIG. 46. Perspective view of a delivery shaft with a
retention latch hidden in certain embodiments.
[0110] FIG. 47A. Side view of a delivery sheath in certain
embodiments.
[0111] FIG. 47B. Cross-sectional view of a delivery shaft in
certain embodiments.
[0112] FIG. 48. Perspective view of a delivery sheath inside a
delivery shaft in certain embodiments.
[0113] FIG. 49A. Side view of a decorticating rod in certain
embodiments.
[0114] FIG. 49B. Side view of a plunging rod in certain
embodiments.
[0115] FIG. 49C. Perspective view of a plunging rod in certain
embodiments.
[0116] FIG. 50A. Representative view of a graft delivery assembly
in use.
[0117] FIG. 50B. Representative view of a graft delivery assembly
in use.
[0118] FIG. 50C. Representative view of a graft delivery assembly
in use.
[0119] FIG. 50D. Representative view of a graft delivery assembly
in use.
[0120] FIG. 50E. Representative view of a graft delivery assembly
in use.
[0121] FIG. 50F. Representative view of a graft delivery assembly
in use.
[0122] FIG. 51A. A graft delivery assembly in certain
embodiments.
[0123] FIG. 51B. A graft delivery assembly, decorticating rod in
certain embodiments.
[0124] FIG. 52A. A plunging rod in certain embodiments.
[0125] FIG. 52B. A plunging rod in certain embodiments.
[0126] FIG. 53A. A graft delivery sheath in certain
embodiments.
[0127] FIG. 53B. A graft delivery sheath in certain
embodiments.
[0128] FIG. 53C. A graft delivery sheath in certain
embodiments.
[0129] FIG. 53D. A graft delivery sheath in certain
embodiments.
DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS
[0130] Disclosed herein are embodiments of a surgical method and
apparatuses associated with a minimally invasive approach for the
percutaneous placement of bone graft material over and between the
transverse processes in association with surgical procedures
involving the spine. There are a number of advantages associated
with the minimally invasive approach to fusing transverse
processes, as described below and defined herein. Included in such
certain embodiments are tools, tool assemblies, and components to
facilitate such surgical approach. Other systems, methods,
features, and advantages of the invention will be or will become
apparent to one with skill in the art upon examination of the
figures incorporated herein, and detailed description. It is
intended that all such additional systems, methods, features, and
advantages included within this description be within the scope of
the invention and be protected by the accompanying claims. It will
be appreciated that certain steps are designed to place bony
material in contact with at least two or more transverse processes
and the intertransverse process space in a less invasive or
minimally invasive way. Less invasive or minimally invasive, as
referred to herein, typically describes performing surgery that may
be accomplished percutaneously and/or through small incisions and
that results in decreased complications, blood loss, scarring, and
the like.
[0131] In general, certain embodiments of the invention are
performed by a medical practitioner, where such medical
practitioner may include any of a number of entities related to a
surgical procedure, including but not limited to surgeons,
physician's assistants, nurses, technicians, neurodiagnostic
technicians, surgical robots and/or anesthesiologists. Certain
embodiments of the invention are performed in conjunction with a
number of instruments, including, but not limited to imaging or
scanning devices such as, for example, biplanar fluoroscopes (also
referred to as C-Arm fluoroscopes). Such imaging or scanning
devices captures images of a patient through various views,
including but not limited to a lateral view, an oblique view, a
posterior and anterior-posterior (AP) view, superior view, and
distal views of the patient. Such imaging or scanning devices are
used in portions of, or throughout the entirety of, surgical
procedures described in certain embodiments of the invention. The
present inventors contemplate that such imaging and scanning
devices may assist medical practitioners in the proper placement
and intended use of the embodiments of the apparatuses and methods
described herein.
[0132] In general, the surgical approaches associated with certain
embodiments of the invention occur after a patient undergoes local
or general anesthesia, disinfection, and other standard procedures
and practices related to surgery and/or spinal surgeries known to
persons having ordinary skill in the art. In certain embodiments of
the invention, a patient is optionally placed under general
anesthesia, remains conscious, and/or otherwise is placed under a
general or local analgesic for the duration of the methods and
procedures described. In certain embodiments, the surgical approach
is performed on a patient placed in a prone position. The inventors
have recognized that an advantage associated with embodiments of
the methods and apparatuses associated with the invention is that
in certain circumstances, local anesthesia may be used which
generally presents less risk to the patient than general
anesthesia.
[0133] Certain embodiments of the invention relate to methods for
adding bony material along two or more transverse processes of
adjacent vertebrae. The methods and apparatuses associated with the
embodiments described herein related to the placement of bony
material in proximity to and directly upon one or more transverse
processes are novel improvements upon common posterolateral fusion
procedures that solve previously unsolved problems.
[0134] As used herein, the term "bony material" may refer to
morselized autograft, allograft bone, and/or bone matter such as
demineralized bone matrix (DMB). The term "bony material" may also
refer to substitutes such as bone glues, materials organic,
inorganic, synthetic, and natural, as well as bone morphogenetic
proteins, stem cells, amniotic membrane, collagen and collagen
derivative preparations, and other compounds and materials
promoting bone growth such as bone morphogenic protein (BMP) in
certain embodiments. In certain embodiments, the term "bony
material" may refer to allograft bone material that is preformed to
facilitate its insertion into the body. In certain embodiments, the
term "bony material" may refer to other materials that may be
implanted in association with generally known spinal fusion
procedures including those other than procedures described herein,
which may include metals, including, but not limited to,
biocompatible metals and alloys, such as titanium, tantalum,
stainless steels, gold, silver, cobalt, chromium, platinum,
ruthenium, rhodium, rhenium, and other alloys thereof, combinations
thereof, and/or other equivalent material intended to bridge two or
more transverse processes through utilization of the method steps
and apparatuses disclosed herein. In certain embodiments, the term
"bony material" may refer to polymers, including, but not limited
to polymethyl methacrylate (PMMA), polyetheretherketone (PEEK),
polymethymethacrylate (PMMA), polyglycolic acid and/or polylactic
acid compounds, polystyrene (PS), polyesters (PET, polycaprolacton,
polyglycolied, poylactide, poly-p-dixanone, poly-hydroxy-butylate),
polyvinylchloride (PVC), polyethylene (PE, HDPE, UHMWPE, etc.),
polyamides (Nylons, aromatic polyamides), polypropylene (PP),
fluorocarbon polymers (PTFE, PTFCE, PVF, FEP) and/or other
biocompatible materials.
[0135] Referring to a flow chart on FIG. 1 describing steps found
in certain embodiments, the surgical procedures that are performed
using instruments, implants, devices, and bony material include but
are not limited to one or more of: (1) posterior-lateral access to
the spine, step 101; (2) decorticate bone surface, step 102; (3)
insert bony material in intertransverse space, step 103; and (4)
close incision, step 104.
[0136] In certain embodiments, fusion of the intertransverse
process further includes specific steps as shown in FIG. 2A-B.
Referring to FIG. 2A, such surgical procedures that are performed
during certain embodiments include: (1) make an incision, step 201;
(2) insert cannulated needle, step 202; (3) insert guide wire, step
203; (4) insert dilator, step 204; (5) insert larger dilators and
dilate path, step 205; (6) insert decortication tool, step 206; (7)
decorticate transverse processes step 207; (8) insert bony material
into intertransverse process path, step 208; and (9) suture
incision, step 209. In the preferred embodiment of the invention,
the steps associated with inserting dilators and guide wires are
further streamlined by the design of a graft delivery assembly, as
shown for example in FIGS. 43-53. Such streamlined steps may
include: (1) make an incision, step 211; (2) insert a graft
delivery assembly, step 212; (3) decorticate transverse process,
step 213; (4) insert bony material into intertransverse space, step
214; and (5) suture incision, step 215. In certain embodiments, a
graft delivery assembly provides an all-in-one solution to perform
steps 212, 213, 214.
[0137] The general anatomical structures that are considered during
the surgical procedures of certain embodiments include, but are not
limited to, the transverse processes. In certain embodiments, a
fusion of transverse processes can be accomplished between
transverse processes in the lumbar vertebrae. It can be appreciated
by those skilled in the art that fusion of such transverse
processes is not limited to the lumbar vertebrae, as vertebrae in
other regions of the spine, for instance, the thoracic vertebrae
302, or cervical vertebrae 301, as shown in FIG. 3, may be fused
with certain embodiments of the invention. The present inventors
contemplate that size variations of the apparatuses described
herein, including related to the radius of the curvature of the
bone graft inserter and/or the diameter of the associated sheath,
may be necessary to specifically accommodate the various dimensions
of the different regions of the spine. Referring to FIG. 3, and
further shown for example in FIG. 4, FIG. 5, FIG. 6A, FIG. 6B, FIG.
7A, FIG. 7B, and FIG. 8, the lumbar vertebrae 303, the sacrum 304
and coccyx 305 are shown as reference to better understand certain
embodiments. In order to better understand certain embodiments of
the invention, certain figures including but not limited to FIG. 4,
FIG. 5, FIG. 6A, FIG. 6B, FIG. 7A, FIG. 7B, FIG. 8, FIG. 11, FIG.
12, FIG. 13A, FIG. 13B, FIG. 19, FIG. 21, FIG. 27, and FIG. 29, may
show the following structures: left 410 and right 411 transverse
processes of the L1 vertebra; left 420 and right 421 transverse
processes of the L2 vertebra; left 430 and right 431 transverse
processes of the L3 vertebra; left 440 and right 441 transverse
processes of the L4 vertebra; left 450 and right 451 transverse
processes of the L5 vertebra; the L1 spinous process 412; L2
spinous process 422; L3 spinous process 432; L4 spinous process
442; L5 spinous process 452; and sacrum 304.
[0138] Referring to FIG. 6B, in certain embodiments, access to the
transverse processes is accomplished with an approach path 601 that
is generally from a superior and posterior position, in a direction
that is generally caudal and anterior. Still referring to FIG. 6B,
such approach path 601 allows access to the L3 right transverse
processes 431, and the L4 right transverse process 441 in certain
embodiments. In certain embodiments, other approach paths that are
further superior or inferior may be used to target other transverse
processes. For example, as shown in FIG. 7A, an approach path 602
allows access to the L2 right transverse processes 421 and the L3
right transverse process 431. In another example, referring to FIG.
7B, in certain embodiments, two approach paths are used for fusing
two adjacent transverse processes, where an superior-posterior
approach path 603 allows access to the L4 right transverse
processes 441 and the L5 right transverse process 451, and
posterior approach path 604 accesses the right L5 transverse
process 451. In certain embodiments, fusion of two or more adjacent
transverse processes involves one approach path 602, as shown in an
embodiment in FIG. 7A. In certain embodiments, fusion of two or
more adjacent transverse processes involves two unique approach
paths 603, 604, as shown in an embodiment in FIG. 7B. It will be
appreciated that approach paths can be established at different
vertebral designated levels along the posterior of the patient to
access transverse processes. In certain embodiments, approach paths
can be created on both sides of the spine to allow for placement of
bony material over and between adjacent transverse processes
located on both hemispheres of the spine. It will also be
appreciated that in varying embodiments of the invention, the
placement of bony material over and between adjacent transverse
processes fusion of transverse processes is not limited to fusion
of transverse processes of only two vertebrae and may be applied in
alternate situations where the fusion of adjacent bone structures
is desired. In certain embodiments more than two transverse
processes may be fused.
[0139] Once a medical practitioner diagnoses and determines the
vertebrae requiring fusion, a patient 801 (for example, shown in
FIG. 8) and the devices are readied for the surgical procedure. In
certain embodiments, the make an incision step 201, 211 shown in
FIG. 2A-B includes the preparation for marking, and creating an
incision in the patient providing access to the spine. Prior to
making an incision, a medical practitioner may place a long
radio-dense object 805, such as a wire, on an exterior surface of
the skin. A medical practitioner may reference images from a
bone-imaging device such as a C-Arm Fluoroscope to provide views
such as a lateral view of a patient laying in a prone position, as
shown in FIG. 8. The images generated by the bone-imaging device
allow a medical practitioner to envision a predicted trajectory 806
to certain regions of the spine. If a predicted trajectory does not
allow access to the desired transverse processes requiring fusion,
the angle or the location of a radio-dense object may be adjusted
and reassessed with a bone-imaging device, until an appropriate
angle or path prediction is achieved prior to marking the point of
incision on the patient's skin. In certain embodiments, a predicted
trajectory 806 of a radio-dense object 805 predicts a transverse
process 421 of L2 as shown in FIG. 8. Still referring to FIG. 8, in
certain embodiments, another angle or path is established. A
medical practitioner may place a second oblong radio-dense object
807 on an exterior surface of the skin. A predicted trajectory 808
of such radio-dense object 807 predicts a path reaching an adjacent
transverse process 431 of L3. In this example, the approach paths
allow fusion of transverse process of L2 421 and L3 431. It will be
appreciated that depending on the transverse processes that require
fusion, a medical practitioner may adjust the mark on the skin of
the patient 801 more rostral or more caudal in reference to the
spine, or either to the left or to the right of a midline 803 of a
patient's spine.
[0140] Referring again to FIG. 8, once an appropriate angle or path
is determined, a medical practitioner may refer to the tip of a
radio-dense object 805, 807 that is in contact with the skin
surface of the patient 801 to mark a region on a patient's back.
Such a mark, made with a pen, marker, or other marking tool, gives
a medical practitioner a reference region to create an initial
incision on a patient's back. It will be appreciated that
embodiments of the invention are performed through a relatively
small incision, as to perform a minimally invasive surgery. In
certain embodiments, as shown in FIG. 9, FIG. 10, FIG. 11, FIG. 12,
FIG. 13A, and FIG. 13B, an incision 804, 809 to the right of a
midline 803 (and/or to the left of a midline in an embodiment of
fusion where appropriate) is created with an incision tool such as
a scalpel. As shown in FIG. 9, and FIG. 10, a patient's buttocks
802 are shown as a reference point. An incision allows access by
instruments, and/or devices that are related to certain embodiments
into the soft tissue and muscle of the patient 801 providing access
to the spinal structure. It will be appreciated that a number of
the following steps described herein may be performed through both
incisions 804 and 809 during certain embodiments of the surgical
procedure. In certain embodiments, it is advantageous to access a
pair of transverse processes from separate approach paths. Through
these separate approach paths, the steps of (1) posterior access to
the spine, step 101; (2) decorticate bone surface, step 102; and
(3) insert bony material in intertransverse space, step 103; shown
in FIG. 1 are performed.
[0141] Decortication of such surfaces is not limited to the
instruments as shown in the examples provided, as other instruments
may be used in embodiments of the surgical procedure described. The
decorticate bone surface, step 102, as shown in FIG. 1, may include
further preparation of the bone surfaces for bone fusion, such as
shaping such surfaces with a bone rasp. Removal of biological
material from surfaces may be accomplished through the use of
instruments including, curettes, dissectors, rasps, probes, burrs,
rongeurs, or forceps through a dilator. In the preferred embodiment
of the invention, the surface of the graft delivery tool most
proximal to the transverse processes incorporates an abrading
surface, as depicted in FIG. 43B.
[0142] In certain embodiments, a target transverse process is
accessed using minimally invasive techniques. For example, the step
of inserting a cannulated needle 202, shown in FIG. 2 includes
guiding a needle to the target transverse process. Referring to
FIG. 10 and FIG. 11, a needle 701, such as a cannulated needle, is
inserted into a patient 801 to a portion of spine, targeting the
transverse process to be fused. In certain embodiments, a needle
701 is linear, sharp at its tip, and preferably has a radio-dense
property. A needle 701 may be in the form of a needle or cannula of
various gauges made of metal, for example Jamshidi.RTM. needles or
cannulated needles. A needle 701 may further include a small
diameter, for example, less than 5 mm, such that penetration of the
needle into the skin or other cellular features of the patient
causes less damage to said skin or other cellular features as
compared to larger diameter needles. The use of a small diameter
needle, as compared to a larger diameter needle, allows the medical
practitioner to more easily adjust the path of the needle 701 if it
is determined that the path is inaccurate with less damage to soft
tissue. The radio-dense property of a needle 701 allows a medical
practitioner to view the approach angle of such needle from the
surface to the correct endpoint using images from a bone-imaging
device to help maintain an accurate path to the targeted transverse
process.
[0143] In certain embodiments, the optional insert guide wire step
203 shown in FIG. 2, involves placing a guide wire through an
incision made in a previous step. In certain embodiments of the
invention, a guide wire 702 is inserted after the insert cannulated
needle step 202. In certain embodiments, as shown in FIG. 12, a
guide wire 702 is placed through the cannula 703 of a needle 701,
and further inserted through the shaft 706 of such needle 701 until
it reaches a surgical site. Subsequently, a needle 701 is removed,
leaving a guide wire 702 in its place. It will be appreciated by
those skilled in the art that access to a surgical can be achieved
using a non-cannulated needle, and further placing a series of
dilators over the non-cannulated needle.
[0144] In certain embodiments, insert dilator step 204, and insert
larger dilators and dilate path step 205 (FIG. 2) optionally
includes the method of placing a series of dilators over a guide
wire in sequence. In one example, a first dilator 707 includes an
opening to slide over a guide wire 702, as shown in FIG. 13A, or in
another example, a second dilator 708 includes an opening to slide
over a first dilator 707, as shown in FIG. 13B. A series of
sequentially larger diameter dilators can be used to widen the path
to a transverse process. A path established through a dilator or
through a cannulated instrument used in certain embodiments of the
invention allows insertion of instruments to the desired location
within the patient 801. Furthermore, a dilator functions as a
pathway for a user to guide instruments, devices, and bony material
such as those described here to the surgical site. In certain
embodiments of the invention, the graft delivery tool incorporates
beveled end 926 as depicted in FIG. 50A, such that the optional
insert guide wire step is rendered unnecessary.
[0145] It will be appreciated by those skilled in the art that the
steps of inserting a cannulated needle 202 followed by the step of
inserting a guide wire 203, may be accomplished by inserting a
first guide wire, then inserting a cannulated device over the guide
wire, removing the first guide wire leaving the cannulated device
in place, and using a dilating devices over the cannulated device
prior to the removal of the cannulated device to establish a
pathway.
[0146] Certain embodiments of the invention further include the
steps of insert decortication tool, step 206; and decorticate
transverse processes step 207; as shown in FIG. 2A. It can be
appreciated that an all-in-one assembly, such as a graft delivery
assembly shown in FIGS. 43-53 can be performed in step 212,
followed by a decorticate transverse processes step 213 (shown in
FIG. 2B). In certain embodiments, the insert decortication tool
step 206 includes placing a decortication tool through a dilator or
a cannulated instrument. In other embodiments, the decortication
tool incorporates a beveled end placed percutaneously over the
transverse processes, and allows an insert decortication tool step
206 to be completed simultaneously with steps 202-204. Scraping of
a bone surface, particularly the cortical bone, causes bleeding,
which advantageously promotes bone healing and/or osteogenesis.
Certain embodiments of decortication tools, allow a medical
practitioner to prepare bone surfaces for advantageous bone growth
when bony material is placed on such decorticated bone surface or
surfaces. In the certain embodiments of the invention, the graft
delivery tool or assembly incorporates an abrading surface 736 as
depicted in FIG. 43B, such that the graft delivery tool or assembly
performs the same intended function as a standalone decortication
tool. In certain embodiments, therefore, the insert decortication
tool step is accomplished by utilizing the graft delivery assembly
or tool itself as the decortication tool.
[0147] In certain embodiments, a decortication tool or the graft
delivery tool incorporating a decorticating surface is used to
decorticate one or more transverse processes. In certain
embodiments, a configuration of a decortication tool, such as the
cutter assembly 709 shown in FIG. 14 includes a cutter sheath 1403,
handle 1401, trigger 1405, a distal end 1402, and a cutter blade
1404. A cutter assembly 709 is used for decorticating a surface
that is perpendicular or near perpendicular to the path of entry,
for example, through an approach path 604 shown in FIG. 7B.
[0148] Referring to FIG. 14, a cutter assembly has a trigger 1405
attached to a collar 1417 with a first pivot 1415. A collar 1417 is
attached to a cutter sheath 1403. A trigger 1405 is also attached
to a second pivot 1414. A second end 1411 of a cutter blade 1404 is
attached to a cutter shaft 1418. The cutter shaft 1418 is secured
to a handle 1401, such cutter shaft 1418 extending internally of a
cutter sheath 1403. Pulling or pushing of a trigger 1405 allows
deployment and retraction of a cutter blade 1404 relative to a
cutter sheath 1403. In certain embodiments, a cutter assembly 709
is passed through a dilator 712, shown for example in FIG. 19. When
a cutter blade 1404 is deployed against a transverse process, it
will be appreciated that rotation of such cutter assembly 709 about
its longitudinal axis allows the cutter to decorticate bone.
[0149] An embodiment of a deployed cutter blade 1404 is shown in
FIG. 15. A cutter blade 1404 begins from a first end 1406, extends
distally and then laterally outward to form a distal segment 1407.
The cutter blade then doubles back at a juncture 1409, extends
laterally inward, further extending proximally and ending at a
second end 1411 to form a proximal segment 1410. The location of a
junction 1409 defines the cutting radius, when a cutter blade 1404
is rotated. Still referring to FIG. 15, such cutter blade has a
cutter edge 1408 on a distal segment 1407 and a proximal segment
1410 has a blunt edge 1412 that, when rotated against a bone
surface (such as that of a transverse process), decorticates the
bone. A distal segment 1407 has an opening 1413 that accommodates a
peg located in a cutter shaft 1418, allowing the distal segment
1407 to be guided as it slides up and down when the cutter is
deployed or retracted.
[0150] In certain embodiments, as seen in FIG. 21, the cutter
assembly 709 may be passed through a dilator 712. Referring to FIG.
22, surface decortication of the transverse process is achieved by
inserting a cutter assembly 709, and by rotating the cutter blade
1404 a longitudinal axis 2201. The angle of decortication suing
such a cutter assembly 709 may range from 65.degree. to 90.degree..
While in the examples shown in FIG. 21 and FIG. 22, a cutter
assembly 709 decorticates the right transverse process of L3 431,
it will be appreciated by those skilled in the art that other
transverse processes may be decorticated using a cutter
assembly.
[0151] In certain embodiments, a decortication tool accesses and
decorticates a surface of a transverse process at an approach angle
other than perpendicular. In certain embodiments, the decortication
tool generally includes, for example, a graft delivery tool 730
(e.g., FIG. 34B), or a decorticating rod 903a, 952 of a graft
delivery assembly 900, 950 featuring an abrading surface 736. In
certain embodiments, an angled tool assembly 710 as shown in FIG.
16 is used to decorticate a transverse process through an approach
path that is 90.degree. or less. For example, an angled tool
assembly 710 may be used to pass through an approach path 602 as
shown in FIG. 7A. In certain embodiments, a decortication tool
accesses a surface of a transverse process through a curvature, as
shown for example in FIGS. 27-33 and FIGS. 42-53.
[0152] In certain embodiments, as shown in FIG. 16, a configuration
of an angled tool assembly 710 includes a handle 1601, an outer
sheath 1603, a head 1602, and a tongue 1604 disposed at an angle.
In certain embodiments, an angled tool assembly further comprises
an inner assembly 704, also shown in FIG. 17. Referring to FIG. 17,
an inner assembly 704 has a handle 1605, a shaft 1606, and an
opening 1608, extending the length from a distal end 1609 to a
proximal end 1610. In certain embodiments, an angled tool assembly
710 further includes a cutter tool 711, as further shown for
example in FIG. 18.
[0153] In certain embodiments, a cutter tool 711 (as shown in FIG.
18) is inserted through an opening 1608 of an inner assembly 704
(as shown in FIG. 17), where such opening extends the length from a
distal end 1609 to a proximal end 1610 of the inner assembly.
Referring to FIG. 18, a cutter tool 711 has, in certain
embodiments, a shaft 1612, a flexible region 1613, a distal end
1614, an abrading surface 736, and a cutter edge 1615. An abrading
surface 1617 (for example, a rasp) has a surface that can
decorticate a surface of a bone. A cutter edge 1615 has a sharpened
edge that can decorticate a surface of a bone. A cutter tool 711
slides back and forth within an opening 1608 of an inner assembly
704. A cutter edge 1615 can protrude out of a distal end 1609 of an
inner assembly 704 as referred to in FIG. 17. Referring to FIG. 18,
a cutter tool 1711 further bends at a flexible region 1613.
Referring to FIG. 16, FIG. 17, and FIG. 18, a cutter tool 711 is
placed through an inner assembly 704, which is then placed through
a sheath 1603 of an angled tool assembly 710. A user, for example
may slide the cutter tool 711 in a back and forth movement within
an inner assembly 704. It will be appreciated that the
decortication of a transverse process may include manipulation of
the tool in a side-to-side action or twisting action. When a cutter
tool is pushed further in, the distal end 1614 of a cutter tool 711
to press against a curved feature 1607 of an angled tool assembly
710 head 1602. The present inventors have recognized that the back
and forth movement, the side-to-side action, and twisting actions a
user may employ during use of a cutter tool, or a decortication
tool functions to accomplish decortication of one or more
transverse processes in a minimally invasive manner.
[0154] Referring to FIG. 19, and FIG. 20A, as an example, an angled
tool assembly 710 is disposed at a right transverse process of L2
421 through a dilator 712. A tongue 1604 is positioned near the
right transverse process of L2 421. Further referring to, FIG. 20B,
an inner assembly 704 is placed within an outer sheath 1603 of an
angled tool assembly 710. Further referring to FIG. 20C, the cutter
tool 711 is placed through the shaft 1606 of an inner assembly 704,
where a handle 1605 in certain embodiments has an opening to
accommodate such cutter tool 711. The cutter tool 711 having a
flexible region 1613 (as shown in FIG. 18) bends and follows the
contour of a curved feature 1607 of a tongue 1604. Through a back
and forth movement, a cutter tool 711 cutter edge 1615 and/or an
abrading surface 736 decorticates a surface of the right transverse
process of L2 421.
[0155] It will also be appreciated that in certain other
embodiments, a cutter tool 711 shaft 1612 is affixed to the inner
assembly 704, whereby the flexible region 1613 and the distal end
1614 protrude from a distal end 1609 of the inner assembly 704. In
such embodiment, a user may slide the inner assembly 704 and cutter
tool 711 simultaneously within an angled tool assembly 710.
[0156] It will be appreciated that in alternative embodiments a
tongue 1604, as shown in FIG. 16, may be provided with differing
lengths, as to more accurately guide an instrument such as a guide
wire or a cutter tool. It will further be appreciated that certain
forms of an angled tool assembly 710 have a curved feature 1607
having an angle ranging from 0.degree. to 90.degree..
[0157] In certain embodiments, a guide wire may be placed through
an angled tool assembly. In such cases, a guide wire may help to
establish a path between two transverse processes. Furthermore, a
flexible dilator may be inserted in such path to deposit bony
material. Referring to FIG. 23A, and FIG. 23B, in certain
embodiments, a guide wire 702a is used to create a path from a
first transverse process to a second transverse process. A guide
wire 702a is placed inside an angled tool assembly 710, and further
inserted from a proximal end 1610 to a distal end 1609 of an inner
assembly 704. As seen in FIG. 23A and FIG. 23B, the path of a guide
wire 702a is initially directed to a first transverse process (for
example, the right transverse process of L2) 421, changing its
trajectory towards second adjacent transverse (for example, the
right transverse process of L3) 431 with the aid of a curved
feature 1607.
[0158] After a guide wire 702a spans from the right transverse
process of L2 421 to the right transverse process of L3 431, an
inner assembly 704 may be removed. A flexible dilator 712a is
inserted through the angled tool assembly 710 by following the
guide wire 702a as shown in FIG. 23C. The flexible dilator 712a may
further be placed between the transverse processes of L2 421 and L3
431. Once placed, the guide wire 702a is removed.
[0159] Referring to the flow diagram in FIG. 2A, the insert bony
material into intertransverse process path step 208 includes
procedures to place bony material in contact with and substantially
between at least two adjacent transverse processes. In one example,
as shown in FIG. 23D, bony material 2406 is inserted through the
flexible dilator 712a, thereby allowing the bony material 2406 to
be placed between the transverse processes of L2 421 and L3 431. In
another embodiment, bone graft is placed by positioning the graft
delivery assembly or tool (for example, an assembly 900, 950 shown
in FIGS. 43A and 51A) over the targeted one or more transverse
processes, and retracting a delivery sheath (for example, sheath
902 shown in FIG. 43A and shaft 951 shown in FIG. 51A) over a
plunger (for example, plunger 903b, 953 shown in FIGS. 49C and 51A)
to force the bony material out of the sheath in proximity to the
transverse processes as the sheath is retracted. Once bony material
is in position, the associated placement apparatuses, which may
include any or the entire graft delivery tool, flexible dilator,
and/or guide wire may be removed. Referring to FIG. 1 and FIG.
2A-B, in certain embodiments, these steps are followed with a step
involving the closing or suturing of the incision 104, 209,
215.
[0160] The present inventors contemplate that in preferred
embodiments of the invention that bony material is placed in the
intertransverse process space after the surfaces of the one or more
transverse processes are decorticated. As shown for example in FIG.
23A, FIG. 23B, FIG. 23C, and FIG. 23D an approach path 604 may
serve as the delivery path of the apparatuses to decorticate the
transverse process of L3 431.
[0161] In certain embodiments, portions of a cutter assembly 709
shown in FIG. 14 or a cutter tool 711 shown in FIG. 18 are made of
materials suitable for decortication and bending. One known
suitable material that approximates the preferred biomechanical
specification for a cutter blade 1404 (seen in FIG. 15), cutter
edge 1615 (seen in FIG. 18), curved feature 1607 (seen in FIG. 16),
a distal end 1614 (seen in FIG. 18), but not limited to such parts,
is an alloy of nickel and titanium (e.g. Ni56-Ti45 and other
alloying elements by weight), such as for example, Nitinol strip
material #SE508, available from Nitinol Devices and Components Inc.
in Fremont, Calif. The material exhibits substantially full shape
recovery (i.e. recovered flexion when strained from 6% to 10%,
which is a factor often better than the recovered flexion at the
strain levels of stainless steel).
[0162] Referring to FIG. 2A, certain embodiments of the insert bony
material into intertransverse process path step 208, includes using
a distending device to place bony material in the space between the
transverse processes. Referring to FIG. 24A and FIG. 24B, an
embodiment of an distending device 713 has a bendable rod 2303,
having a sheath 2302, a portion of such sheath 2302 having an
attachment point 2305 proximal to a distal end 2300 of a bendable
rod 2303. The expansion of the sheath 2302 creates a space 2306
between the sheath 2302 and bendable rod 2303 as shown in FIG. 24B.
An opening 2304 of the sheath 2302, located near the proximal end
2301 of the bendable shaft 2303, allows a medical practitioner to
place material into the opening 2304 to deliver bony material in
the space 2306.
[0163] Referring to FIG. 25, in certain embodiments, a distending
device 713 is placed between the transverse processes of L2 421 and
L3 431. In one example, the distending device 713 is guided using
an angled tool assembly 710. Bony material 2406 is inserted through
an opening 2304 of a sheath 2302 of a distending device 713. A
distal end of a distending device 713 is filled with bony material
2406 in an area between the transverse process of L2 421 and the
transverse process of L3 431.
[0164] Referring to FIG. 1, certain embodiments of the insert bony
material in intertransverse space step 103, includes steps to open
a distal end of a distending device previously filled with bony
material, removing the distending device, and leaving a deposit of
bony material between a first transverse process and a second
transverse process. A dilator 712 or access portal placed in a
desired path directed to the transverse process of L3 431 as shown
in FIG. 26, allows access with various medical instruments, such as
a surgical scissor to cut, open, or otherwise distribute contents
of the distending device 713. In one example, a cutting device,
such as a surgical scissor, is used to cut a distal portion of the
sheath 2302 of the distending device 713. The contents of a
distending device 713 (e.g., bony material 2406) are released into
the intertransverse process space as the distending device 713 is
removed. In certain embodiments, once the bony material is in
position, the dilator 712 and guide wire are removed.
[0165] In certain embodiments, the surgical procedure to accomplish
fusion of adjacent transverse processes is accomplished through a
generally curved pathway. Referring to FIG. 1, an embodiment of
such a procedure includes the following steps: (1)
posterior-lateral access to the spine, step 101; (2) decorticate
bone surface, step 102; (3) insert bony material in intertransverse
space, step 103; and (4) close incision, step 104 are accomplished
through a generally curved pathway. An example of such a curved
pathway is established, for example, with assemblies and tools
shown in FIGS. 27-33 and 42-53.
[0166] Referring to FIG. 27, in certain embodiments of an invention
for the fusion of adjacent transverse processes, the space between
the transverse processes of L2 421 and L3 431 is accessed with a
curved needle 714. In certain embodiments, a curved needle 714 is
cannulated. As shown, for example, in FIG. 27, a curved needle 714
is inserted through the tissue located posterior to the target
transverse processes from a posterior approach. For example, a
curved needle is 714 passed through the tissue of a patient from a
posterior approach, posterior to a right transverse process 431 of
L3, and a right transverse process 421 of L2. Referring to FIG.
28A, a curved needle 714 has a tip 2801. In certain embodiments,
the arc of the curved needle 714 has a diameter typically between
75 mm and 200 mm, allowing access to two adjacent transverse
processes. It will be appreciated that the arc of a curved needle
714 can vary depending on the level that the transverse process
targets.
[0167] Referring to FIG. 28B, in an embodiment, a dilator 715 is
cannulated, and is inserted over a curved needle 714. Further
referring to FIG. 28C, and FIG. 28D, a series of dilators 716, and
717 are inserted over each successive dilator (e.g., dilator 716
slides over dilator 715) to expand the pathway towards the
transverse processes. In certain embodiments, dilators have a
curved form generally matching the curvature of the arc of a curved
needle. It will also be appreciated that dilators can refer to
surgical instruments having a straight form.
[0168] In an embodiment, an access portal 718 as shown in FIG. 29
is further slid over a dilator 715, 716, 717 or a needle 714 as
shown in FIG. 28A, FIG. 28B, FIG. 28C, and FIG. 28D. A user may
generally insert instruments, devices, tools, bony material, and
the like through an access portal or a dilator. Referring to FIG.
30A and FIG. 30B, in certain embodiments of an access portal 718,
there is an opening 3002 running longitudinally.
[0169] In an embodiment, an access portal 718 may be placed in the
vicinity of two transverse processes (L2 transverse process 421,
and L3 transverse process 431, for example), as seen in FIG. 29. In
certain embodiments, as shown for example in FIG. 31A, a proximal
end 3103 is passed through a first incision 3101, and a distal end
3104 is passed through a second incision 3102. It will be
appreciated that in varying embodiments, the instruments, including
curved needles, dilators, and access portals may not necessarily
pass through a second incision 3102. It will also be appreciated
that a first incision 3101 may originate either superior or
inferior to the surgical site (i.e. the location of the fusion). It
will also be appreciated that the pathway to the surgical site may
be directed in an inferior to superior direction, or a superior to
inferior direction.
[0170] Referring to FIG. 30B, certain embodiments of an access
portal 718 have a small longitudinal opening 3001 that allows
passage of certain instruments. A small longitudinal opening 3001
in those embodiments runs longitudinally along the body of the
access portal. In certain embodiments, a small longitudinal opening
3001 is located on the exterior curved surface of an access portal
718. Referring to FIG. 31B, one or more needles 701, such as
Jamshidi.RTM. needles, are passed through an access portal 718 to
transverse processes through a small longitudinal opening 3001. In
certain embodiments, as further shown in FIG. 31B, a guide wire 702
is placed through a cannula 703 of the needle 701 and advanced
through a shaft 706 of the needle 701 until it reaches the
transverse process. Subsequently, the needle 701 is removed,
leaving the guide wire 702 in place, as shown for example in FIG.
31C. Once one or more guide wires 702 are in place, a curved needle
714 may take the place of the access portal to preserve the curved
path 3201, as shown in the diagram in FIG. 32A.
[0171] In certain embodiments, using the guide wires 702 as guides,
a medical practitioner may insert one or more dilators 719 to the
transverse processes 421 and 431, as shown in FIG. 32B. In certain
embodiments, a medical practitioner uses decortication tools,
including, but not limited to a cutter assembly 709 seen in FIG.
14, rasps, files, and drills to decorticate the surface of the
transverse processes through a dilator.
[0172] Referring to FIG. 33A, in certain embodiments, bony material
2406 is inserted into an end of a dilator 717. A plunger 720 is
further inserted to deposit bony material 2406, as shown in FIG.
33B. Referring to FIG. 33C, a plunger is used to push bony material
2406 into the intertransverse space while a dilator 717 is pulled
out, which leaves the bony material 2406 in place as further shown
in FIG. 33D.
[0173] In certain embodiments, bony material is delivered to an
intertransverse space using a graft delivery tool. In certain
embodiments, a graft delivery tool is used to open a path to the
transverse process after an initial incision is made on the skin of
a patient. In certain embodiments, a graft delivery tool is used to
deliver bony material on at least one transverse process surface.
In certain embodiments, a graft delivery tool incorporates features
to decorticate the bone surface of one or more transverse
processes. In certain embodiments, the graft delivery tool may
operate independently from any guide wires or dilators, and act to
define the path through the soft tissue itself with the aid of a
beveled end.
[0174] A graft delivery tool 730, as shown in embodiment in FIG.
34A, FIG. 34B, and FIG. 34C, includes a handle 731, a first segment
732, and a second segment 733. In certain embodiments, a first
segment 732 and a second segment 733 are connected with a segment
with a bend 737. A distal end of a second segment 733 has a distal
end 735. Referring to FIG. 34C, certain embodiments of a graft
delivery tool 730 comprises a first segment 732 has a curvature. In
certain embodiments, a graft delivery tool comprises a plurality of
individual interconnected segments further comprising a first
segment 732 and a second segment 733 and a segment comprising a
bend 737. In alternate embodiments a graft delivery tool 730
comprises a single piece further comprising a bend 737, a first
segment 732, and a second segment 733. In certain embodiments as
shown in FIG. 35, a first segment 732, a bend 737, and a second
segment 733 each having a hollow profile creating a duct 741,
allowing the depositing of bony material or other materials. In
certain embodiments, a first segment 732, a bend 737, and a second
segment 733 each having a solid profile. As shown in FIG. 34D, it
will be appreciated that a graft delivery tool 730, of solid
profile or hollow profile, may be used to establish a pathway 3402,
for the subsequent delivery of bony material between adjacent
transverse processes.
[0175] In certain embodiments, a graft delivery tool 730 having a
solid profile may be used by a practitioner to create a pathway
3402 from the exterior of the body to the transverse processes
through an incision 3404 of the skin 3403, for example, as shown in
FIG. 34D. In certain use cases, graft delivery tool 730 having a
solid profile may be inserted to create a pathway to the
intertransverse space after performing a pedicle screw/rod fixation
procedure. In an embodiment, using an incision created while
performing a pedicle screw/rod surgery, the graft delivery tool 730
having a solid profile may be inserted through an incision to
create a pathway 3402 in proximity or direct contact with adjacent
transverse processes and spanning therebetween, as shown in FIG.
34D.
[0176] In an embodiment, referring to FIG. 34A, variations in the
length 3401 of a second segment 733 allow a practitioner to span
across two or more transverse processes. For example, in an
embodiment, a second segment 733a having a length of approximately
45 mm to 55 mm is appropriate for delivering bony material between
two adjacent transverse processes of the lumbar spine, as seen in
FIG. 34E. In certain embodiments, a second segment 733b having a
length of approximately 75 mm to 85 mm is appropriate for
delivering bony material between three adjacent transverse
processes of the lumbar spine, as seen in FIG. 34F. In other areas
of the spine, for instance thoracic spine and the cervical spine,
the lengths of the first and second segments in certain embodiments
may vary in relation to the distance between the adjacent
transverse processes. Therefore, a user may choose a graft delivery
tool 730 having a second segment 733 of appropriate length 3401
spans between the transverse processes intended to be fused.
[0177] Referring to FIG. 34B, certain embodiments of a graft
delivery tool 730 incorporate an abrading surface 736 that features
texturing allowing for decortication of a bone surface. In varying
embodiments of the invention, the terms "abrading surface" and
"decorticating surface" may be used interchangeably. In certain
embodiments of the invention, the abrading surface 736 is on a
graft delivery assembly as depicted in FIG. 43B. The abrading
surface 736 may have features or patterns on the graft delivery
tool including, but not limited to single cut, double cut, curved
tooth, rasps, rifflers, and knurling. In certain embodiments, an
abrading surface 736 includes one or more surface modifications
that facilitate decortication of bone. In such embodiments, once a
graft delivery tool or assembly is inserted into the patient to the
desired area proximal or in contact with at least one transverse
process, the user may apply force to the graft delivery tool or
assembly (for example, a graft delivery tool 730), applying
pressure on one of the desired transverse processes and manipulate
the graft delivery tool or assembly to abrade the posterior surface
of the targeted transverse processes. In one example, the graft
delivery tool 730 may be manipulated in a variety of manners
including back and forth in a lateral direction, back and forth in
a superior to inferior direction, rotatively around an axis of the
second segment 733 or a combination thereof. Such manipulations may
take place percutaneously and without making further incisions in
the preferred embodiment of the invention. In certain embodiments,
a graft delivery tool 730 further comprising an abrading surface
736, as exemplified in FIG. 34B, may be inserted into a pathway
3402 (shown in FIG. 34D) to decorticate the surfaces of the right
L3 transverse process 431 and the L4 transverse process 441. In
certain embodiments, an abrading surface 736 is found on an outer
surface of a tool or element, including but not limited to a
decorticating rod 903a (FIG. 49A), 952 (FIG. 51B), and a delivery
shaft 951 (FIG. 53A).
[0178] In certain embodiments, as shown in FIG. 35, a graft
delivery tool 730 with hollow profile comprises a plunger head 740
located inside a second segment 733. The plunger head 740 is
interconnected with a plunger 738 that is located at a proximal end
of a first segment 732. The plunger head 740 and plunger 738 are
interconnected by a connector 739, where the connector 739
traverses through the hollow profile of the first segment 732, a
bend 737 and at least a portion of the second segment 733.
Depressing the plunger 738 advances the plunger head 740, allowing
a user to control the dispensation of loaded bony material
delivered through a duct 741. In certain embodiments, a connector
739 comprises a flexible material. A connector 739 may comprise a
material make-up including, but not limited to nickel-titanium
alloys such as Nitinol, stainless steel and titanium. In alternate
embodiments, a connector may comprise a plastic or polymeric
material.
[0179] In certain embodiments a graft delivery tool 730 may house
bony material 2406 loaded in the duct 741 of the second segment 733
on the distal side of the plunger head 740. It will be appreciated
that as the bony material is loaded in the duct 741 of the second
segment 733, the bony material pushes the plunger head 740, away
from the distal end of the second segment. The graft delivery tool
730, with loaded bony material 2406 may be inserted through an
pathway 3402, placing the second segment 733 in proximity or in
contact with two or more adjacent transverses processes. A
practitioner may then retract the graft delivery tool 730 back
through the pathway 3402 while depressing the plunger 738 to
deposit the bony material spanning between the transverse
processes.
[0180] Referring to FIG. 36A, a cross-section A-A of the second
segment 733 of a graft delivery tool 730 is designed with a number
of profiles in certain embodiments. As shown in FIG. 36B, in
certain embodiments, a cross-section 733a is substantially
circular. Referring to FIG. 36C, in certain embodiments, a second
segment 733 has a cross-section 733b with a rounded form 733d
inter-spaced with a straight form 733c. Referring to FIG. 36D, in
certain embodiments, a second segment 733 has a cross-section 733e
comprising a rounded form 733f with a first radius and a second
rounded form 733g with second radius. Referring to FIG. 36E, in
certain embodiments, a second segment 733 has a triangular
cross-section 733h with legs of straight or curved form. Referring
to FIG. 36F, certain embodiments have a second segment 733 with a
generally rectangular cross-section 733i. It will be appreciated
that the cross-section of a second segment 733, a bend 737, and/or
a first segment 732 may comprise any shape, including, but not
limited to polygons, ovals, rhomboids, and fabiforms. It will be
appreciated that the cross-section of a graft delivery tool 730 may
be a solid body, or have a hollow profile creating a duct to hold
bony material. It will also be appreciated that in certain
embodiments, the cross sections 733a-733i and other cross sections
may be applied to other instrumentation disclosed herein (for
example, a delivery shaft 901, 951, a graft delivery sheath 902, a
curved rod 903, a decorticating rod 903a, 952, a plunging rod 903b,
953 and other instruments, tools, and assemblies disclosed
herein).
[0181] Referring to FIG. 37A, FIG. 37B, and FIG. 37C, showing a top
view of a second segment 733, certain embodiments may include a
distal end 735 of shapes including, but not limited to, a pointed
tip 735a, a rounded tip 735b, a blunt tip 735c, and a hemispherical
tip. It will be appreciated that in certain embodiments, a distal
end 735 may have a beveled end to allow separating tissue.
[0182] Referring to FIG. 38A showing a bottom view of a second
segment, an abrading surface having knurling 736a allows
decortication of bone. Certain embodiments include spacers 736b
between surfaces 736a, as shown in FIG. 38B. Certain embodiments
have an abrading surface comprising splines 736c, as shown in FIG.
38C. Further referring to FIG. 38D, certain embodiments comprise a
splined surface 736c located between a knurling surface 736a.
[0183] Referring to FIG. 39, in certain embodiments, a second
segment 733 comprises gradations that can be viewed under
radiography, such as notches 742. In certain embodiments notches
742 allow a user to observe the location and placement of a graft
delivery tool 730 when viewed under a radiograph. It will be
appreciated that notches 742 may be found on other tools disclosed
herein, including, but not limited to, for example a curved needle
714, dilators 715, 716, 717, and an access portal 718, as shown in
FIG. 28D.
[0184] In certain embodiments, a graft delivery tool 730 with a
hollow profile has a ratcheting device 757 as shown in FIG. 40. The
ratcheting device 757 further comprises a plunger 738, an inner
shaft 743, and a pawl 744. A spring 747 displaced over the inner
shaft 743 interfaces with a medial step feature 748 of the inner
shaft. When placed within a handle 731, the spring interfaces
between a stop 749 and the medial step feature 748 maintaining a
sprung offset between the medial step feature 748 and the stop 749.
The pawl 744 interfaces with teeth 745 located on the proximal end
of a connector 739. The teeth 745 only allow the movement of the
connector 739 through the interface with the pawl 744 in a distal
direction, extending the connector and a connected plunger head 740
toward the distal end of the graft delivery device 730. When the
plunger 738 is depressed, the pawl 744, engaged with the teeth 745,
advances the connector 739 distally. Upon release of the plunger
738, the spring 747 retracts the inner shaft 743 and the pawl 744,
disengaged from the teeth 745 leaves the connector 739 and plunger
head 740 in place. A user may successively advance the plunger head
740 and any loaded bony material 2406 through repeated depression
of the plunger head 738.
[0185] In certain embodiments, a graft delivery tool 730 with
hollow profile comprises a thumb-wheel device 758 further
comprising a thumb-wheel 750 as shown in FIG. 41A. A thumb-wheel
750 is attached to a tab 756 extending from a handle 731. A pin 754
secures the thumb-wheel 750 to tab 756.
[0186] In certain embodiments, referring to FIG. 41B, a graft
delivery tool 730 comprising a thumb-wheel device 758 further
comprises a thumb-wheel 750 secured to a handle 731 with a pin 754
further comprises a pinion 753 that engages with a rack 751
comprising teeth 745, disposed within the handle 731. The proximal
end of the rack 751 is attached to a plunger 738 and the distal end
of the rack is connected to the distal end of a connector 739. The
distal end of the connector 739 is further attached to a plunger
head 740. A user may rotate the thumb-wheel 750 in a first
direction to extend the plunger head 740 in a distal direction to
dispense loaded bony material in a second direction to retract the
plunger head 740 in a proximal direction. The retraction of the
plunger head 740 may be desired to allow a practitioner to load
bony material into the graft delivery tool 730 for successive bony
material depositions.
[0187] It will be appreciated that in certain embodiments, a graft
delivery tool with a hollow profile uses a curved first segment
with the various embodiments of the handles disclosed. Referring to
FIG. 42, for example, a graft delivery tool 730 comprises a first
segment 732 and second segment 733 having a continuous curved
profile attached to a handle 731 and further comprising a
thumb-wheel device 758. It will be appreciated that the length and
arc radius of a first segment 732 may be modified to accommodate
the spanning the intertransverse space between two or more
transverse processes.
[0188] Referring to, for example, FIG. 43A-B, certain embodiments
of the invention include a graft delivery assembly 900, further
including a delivery shaft 901, delivery sheath 902, and at least
one curved rod 903. As shown in FIG. 44A-D, certain embodiments of
a delivery shaft 901 have a tool insertion end 904 and a graft
delivery end 905. Referring to FIG. 44D, a delivery shaft 901
follows a central axis 911, whereby a shaft pathway 907 is a
pathway following a central axis 911 and allows communication
between the tool insertion end 904 and a graft delivery end 905. In
certain embodiments, a central axis 911, 960, or a portion thereof
may generally follow a curved line. For example, as shown in FIG.
44D, a central axis may be defined by an arc having a radius
912.
[0189] In certain embodiments, a central axis curvature has a
radius of between 10.14 cm (4 inches) and 20.32 cm (8 inches),
preferably with a radius of 15 cm (6 inches). However, other radii
may be used in certain embodiments. Generally, a central axis
closely aligns with the lordotic curvature of certain regions of
the spine. It can be appreciated that a central axis may also
follow an arc with a logarithmic spiral, an arc comprising more
than one radius, or other path having a portion or all of such path
having a curvature. The shaft pathway is a pathway generally allows
passage of other instruments, including a delivery sheath 902, a
curved rod 903, bony material, and other objects described herein
and elsewhere relevant to surgical procedures. It will be
appreciated that a delivery sheath 902 and a curved rod 903 may
also be referred to as a curved element.
[0190] Referring to FIG. 44B-D, a delivery shaft 901 includes a
slit or a slot 906 that communicates with the shaft pathway 907. A
slot 906 typically runs along the length of a delivery shaft. In
certain embodiments, more than one slot 906 may be found on a
delivery shaft 901. Such slot 906 guides a protrusion or a jut of a
delivery sheath 902 or a curved rod 903, shown for example in FIGS.
50B, 50D, and 50F.
[0191] Certain embodiments of a delivery shaft 901 also include a
handle 908. It will be appreciated that a handle may be found in
any number of sizes or shapes that allow gripping or handling of
the delivery shaft. In one example, as shown in FIGS. 44A-D, a
handle is located proximal to the tool insertion end 904, although
a handle may be found closer to the graft delivery end 905 and/or
between the tool insertion end 904 and the graft delivery end 905.
In certain examples, a handle may be defined by having a handle
axis 913, as shown in FIG. 44D. In certain embodiments, a handle
axis may include a curvature aligned with the central axis 911. In
yet another embodiment, a handle axis may be generally 90.degree.
to the central axis 911, in yet other embodiments as shown in FIG.
44D a handle axis may be oblique to the central axis 911, and in
yet other embodiments, a handle axis is generally in a direction
that is radial from the central axis 911. In certain embodiments, a
handle axis is perpendicular to a tangent of the central axis.
[0192] Certain embodiments of a delivery shaft 901 also include
ventilation holes 910 allowing sterilization of the assembly. It
will be appreciated that ventilation holes 910 may be found in
other instruments, assemblies, and components as described herein.
In certain embodiments, a delivery shaft 901 is a unibody assembly,
and in other embodiments a delivery shaft 901 includes at least two
pieces.
[0193] In certain embodiments, a delivery shaft includes a
retention lock that restricts movement of a curved element relative
to the delivery shaft. In certain embodiments, as shown in FIGS.
44A-44D and FIG. 45A-B, a retention latch 909 is a type of
retention lock. Embodiments of a retention latch 909 have a collar
portion 914 and a latch portion 915. A collar portion 915 wraps
around a delivery shaft 901. In certain embodiments, a collar
portion 914 has a cutout 916 that permits sliding of a delivery
sheath or a curved rod through the cutout 916 when the retention
latch is in an unlocked position, and restricts sliding when in a
locked position. In certain embodiments, a delivery shaft 901
includes a radial surface feature 917 allowing a retention latch
909 to be rotatably restricted. A radial surface feature 917 may
include, for example, a radial groove (shown in FIG. 46), radial
tongue, radial protrusion, and other such features that
correspondingly mates with a retention latch 909 or other retention
lock, as to restricts certain movements about the delivery shaft
901. In certain embodiments, a retention latch 909 is rotatably
restricted to a certain angle, for example, restricted to a
90.degree. rotation.
[0194] It will be appreciated that a retention lock includes any
number of mechanisms to restrict movement of an instrument
(including delivery sheath, curved rod, or other instruments) from
sliding through a shaft pathway. For example, a retention lock
includes, but is not limited to, a compression latch, clamp, tube
clamp, pin, threaded members threading orthogonally to a central
axis (e.g. a wing-nut), a spring-loaded ball detent, and fastener,
and any other mechanical fastening structure appreciated by those
skilled in the art to temporarily restricts movement of such
instrument.
[0195] As seen in FIG. 47A and FIG. 47B, a delivery sheath 902
includes a first end 918 and second end 919, where a sheath pathway
920 is a pathway generally following the central axis 911 and
communicating the first end 918 and second end 919. The sheath
pathway is a pathway generally allows passage of other instruments,
such as curved element, a curved rod 903, bony material, and other
objects described herein or elsewhere relevant to surgical
procedures.
[0196] Still referring to FIG. 47A and FIG. 47B the sheath pathway
920 further defines an exterior surface 922 and an interior surface
923. The delivery sheath exterior surface 922 has a protrusion or
jut 921, which can act as a handle. When installed in a delivery
shaft 901, the delivery sheath 902 slides through the shaft pathway
907, and the jut 921 slides or passes through the slot 906, as
shown in FIG. 48. Still referring to FIG. 48, it can be seen that a
jut 921 can extend beyond the exterior surface 932 of the delivery
shaft 901. As seen, for example, in FIG. 47B, a jut in certain
embodiments generally follows an axis 934. The jut may be an
additional handle, having a length to accommodate one to two
fingers, and other examples, the jut may extend further to
accommodate gripping with more than one finger. A user can, for
example, hold the assembly 900 by the handle 908 and pull in (or
push apart) on a jut 921 (being an additional handle in this
example) using a finger or multiple fingers, a thumb, or a second
hand relative to a handle 908. In certain embodiments, a jut axis
934 and handle axis 913 are co-planar with said central axis 911,
resembling a trigger. In certain embodiments, a handle axis and jut
axis are coplanar to each other.
[0197] Referring to FIG. 48, embodiments of a delivery shaft 901
optionally has a slot end 906a, 906b that further restricts sliding
or passing movement of the delivery sheath 902 past a certain
point. A slot end 906a, 906b, for example, defines the slot being
located within the body of delivery shaft 901, although it would be
appreciated that in other embodiments, a slot communicates with a
shaft end. Referring to FIG. 47A, a delivery sheath 902 optionally
includes an o-ring 930 to create frictional resistance between a
delivery sheath and delivery shaft interior surface 933 (FIG. 46).
Also shown in FIG. 48, a retention latch 909 is in an open position
as to allow slidable movement of the delivery sheath 902.
[0198] In certain embodiments, a delivery sheath outer diameter is
between 10 mm and 20 mm, with preferred embodiments having a 12 mm
to 13 mm outer diameter. A delivery sheath inner diameter is
between 5 mm and 19 mm, with preferred embodiments further having
an 11 mm inner diameter, although some embodiments may have inner
and outer diameters outside of these ranges.
[0199] Referring to FIGS. 49A-C, embodiments of a curved rod are
shown. In certain embodiments, a curved rod is further defined as a
decorticating rod 903a as shown in FIG. 49A, and as a plunging rod
903b as shown in FIG. 49B-C. Referring to FIG. 49A-B, a curved rod
is generally aligned with a central axis 911, and is further
defined by a first end 924 and a second end 925. Certain
embodiments of a decorticating rod 903a have an abrading surface
736 allowing decortication of bone surfaces.
[0200] Certain embodiments of a curved rod have a beveled end 926
as shown in FIG. 49A, allowing separation of tissue as the assembly
is inserted into the body. It will be appreciated that a second end
of a curved rod may have a frustoconical, conical, hemispherical,
ellipsoidal, torispherical, or other type of beveled end allowing
separation or cutting of tissue. In certain embodiments, a graft
delivery end 905 of a curved shaft 901 has a beveled edge to match
the second end of a curved rod. In certain embodiments, a plunging
rod 903b has a second end 925 with a surface that allows pushing
bone graft to the surgical site. In one example, a curved rod has a
blunt end 927, as shown in FIG. 49B-C, although other types of ends
may be used. In certain embodiments, a plunging rod 903b has a
second end 925 terminating within a sheath pathway, leaving a space
between a plunging rod second end 925 and a delivery sheath second
end 919, where such space can be filled with bony material. It will
also be appreciated that in certain embodiments, a plunging rod
903b has an abrading surface. In yet other embodiments, a curved
rod has an inner pathway aligning with the central axis and
communicating with a first end and a second end. In such
embodiment, instruments, implants, or bony material may be inserted
through such pathway.
[0201] It will be appreciated that in certain embodiments, the arc
length of an assembly's elements may vary. In certain embodiments,
a plunging rod 903b, has an arc length shorter than a delivery
sheath's 902 arc length. This difference allows bony material to be
temporarily stored in a delivery sheath pathway 920, between a
delivery sheath second end 919 and a plunging rod second end 925.
It can be appreciated that in certain embodiments, a first curved
element may have a different arc length than a second curved
element, allowing temporary storage of bony material.
[0202] Referring to FIG. 49C, certain embodiments of a curved rod
have volume markers 931. When inserting a curved rod (e.g.,
plunging rod) through the assembly 900, the volume markers 931
allow one to determine the volume of bony material being inserted.
It will be appreciated that volume markers may be placed on other
components described herein, including, but not limited to the
delivery sheath. Still referring to FIG. 49C, a curved rod (e.g.
plunging rod) optionally has an o-ring 930 to create frictional
resistance between a delivery sheath and curved rod.
[0203] In certain embodiments, a curved rod includes a protrusion
or a jut from an external surface of such curved rod. In certain
embodiments, a mating feature is understood to be a type of jut. In
certain embodiments, a mating feature mates with a retention lock.
Referring to FIGS. 49A-C, an embodiment of a mating feature 928,
can mate with a retention latch 909 to restrict movement of a
curved rod relative to the delivery shaft. It will be appreciated
that a retention lock interacting with a mating features includes,
but is not limited to, a retention latch, compression latch, clamp,
tube clamp, pin, threaded members threading orthogonally to a
central axis (e.g., a wing-nut), a spring-loaded ball detent, and
fastener, and any other mechanical fastening structure appreciated
by those skilled in the art to temporarily restricts movement of a
curved rod.
[0204] Referring now to FIG. 51A-B, other embodiments of the
invention include a graft delivery assembly 950 that includes a
graft delivery shaft 951, and a curved element. In FIG. 51A-B, a
curved element, such as a decorticating rod 952, and a plunging rod
953 are shown.
[0205] Certain embodiments of a delivery shaft 951, shown for
example in FIG. 51A and FIGS. 53A-D, have a tool insertion end 958
and a graft delivery end 959. Referring to FIG. 53A, a delivery
shaft 951 follows a central axis 960, whereby a shaft pathway 961
follows the central axis 960 and communicates the tool insertion
end 958 and the graft delivery end 959. In certain embodiments, a
graft delivery end 959 has a beveled end to separate tissue while
advancing such instrument. It can be appreciated that certain
embodiments of a graft delivery end includes a tip that allows
cutting through tissue. As seen in FIG. 53A, certain embodiments of
a delivery shaft include an abrading surface 736. Still referring
to FIG. 53A, delivery shaft 951 has a handle 954 and a shaft
segment 962.
[0206] In certain embodiments, handles having certain
configurations are used. Generally, some of these handle
configurations allow for simultaneous gripping of a graft delivery
shaft 951, and decorticating rod 952 or plunging rod 953. In one
example, a handle 954b (referring to FIG. 53B) is generally
oriented along the central axis 960. In another example, a handle
954, 954a (referring to FIG. 53A) includes a grip 964a following a
handle axis 965a, where a handle axis 965a is perpendicular to a
tangent of the central axis 960. It will be appreciated that a
handle axis 965a, 965b is not limited to such orientation, and may
be located generally oblique to a central axis 960. In yet other
embodiments, a handle 954, 955, 956 (seen in FIGS. 51B, 52A, 53A-D)
further includes a syringe handle 954b (referring to FIG. 53C). In
yet another example, a handle 954, 955, 956 includes a thumb tab
954c (referring to FIG. 53D). It will also be appreciated that
other handles disclosed herein have these handle variations in
certain embodiments.
[0207] Furthermore, still referring to FIG. 51A and FIGS. 53A-D, a
delivery shaft 951, includes a retention lock, such as a retention
fastener 957. A retention fastener 957, having a threaded end,
engages with a threaded opening (not shown) in communication with
the sheath pathway. Tightening or loosening of the retention
fastener 957 therefore regulates the passage of the decorticating
rod 952, and the plunging rod 953.
[0208] Referring to FIG. 51A-B and 53A, a decorticating rod 952 and
plunging rod 953 is aligned with a central axis 960, being able to
pass through the shaft pathway 961 of the graft delivery shaft 951.
Embodiments of a decorticating rod 952 have an abrading surface
736. In certain embodiments, an end 963 of a decorticating rod 952
has a beveled end to separate tissue. In certain embodiments, an
end 963 of a decorticating rod 952 has a blunt end. Certain
embodiments of a decorticating rod 952 and plunging rod 953 include
a handle 955, 956.
[0209] Referring to FIG. 52A-B, in certain embodiments, a handle of
a plunging rod 953a, 953b (or a decorticating rod in some
embodiments) has a grip 964b aligned with a handle axis 965b, where
a handle axis 965b is perpendicular to a tangent of the central
axis 960. A plunging rod 953 has volume markers 931 to indicate the
volume of bony graft dispensed from the assembly tip.
EXAMPLE 1
[0210] In certain embodiments, the following exemplary steps are
employed to access the intertransverse process area for
decortication of the transverse processes and delivery of bony
material. In preferred embodiments, the following steps are
performed following surgical procedures involving placement of
percutaneous pedicle screws, although in other embodiments, these
steps may be performed prior to or during such procedure.
[0211] 1. Assemble instruments by placing the delivery sheath 902
through the delivery shaft 901.
[0212] 2. Lock the delivery sheath 902 in place by rotating the
lower retention latch 909 to a lock position.
[0213] 3. Lock the decorticating rod 903a within the delivery shaft
901 by rotating the upper retention latch 909 to engage with the
decorticating rod mating feature 928.
[0214] 4. If an adequate incision has not already been created,
create a 1-2 cm incision 929 approximately two to three levels
cephalad or caudal from the vertebral level requiring graft
delivery (in some cases, approximately 5 cm laterally from the
spinous process) (see, for example, FIG. 50A). In certain
embodiments, medical practitioners may use a variety of instruments
(such as Jamshidi.RTM. needles, probes) to target the intended
levels.
[0215] 5. Insert an embodiment of the assembly 900 (also described
in Example 1, steps 1-3) through the skin incision, maneuvering the
instruments to create a pathway to the surgical site. In certain
embodiments, the assembly 900 has a beveled end 926 separating
tissue to create a pathway to a first transverse process, and
subsequently to a second transverse process (or more). If
percutaneous pedicle screws have already been placed, position the
end to roughly align with the most inferior/superior pedicle screw,
lateral to the pedicle screw or pedicle screw tower. The concavity
of the instruments should be directed out of the patient's skin
(see, for example, FIG. 50A).
[0216] 6. Observe fluoroscope from a lateral view to confirm
trajectory and placement of the instruments to the desired
vertebral level of interest. The delivery sheath should be located
directly between the two transverse processes at the level of
interest.
[0217] 7. Rotate the delivery sheath lower retention latch 909a to
the unlocked position, and pull back the delivery sheath 902 by
handling the delivery sheath jut 921 to reveal the decorticating
rod 903a (see, for example, FIG. 50B). In certain embodiments, a
user may grasp the handle 908, and the jut 921 with a finger (e.g.
index, fifth digit, thumb) or multiple fingers.
[0218] 8. While holding the handle 908 on the delivery shaft,
maneuver the assembly along the bony region of interest using an
axially rotating motion, as well as a push-pull motion along the
axis of the spine such that the abrading surface 736 decorticates
the transverse processes (see, for example, FIG. 50C).
[0219] 9. Once decorticated, re-deploy the delivery sheath 902, and
rotate the retention latch 909 to lock the delivery sheath. Check
fluoroscopy for location of the instruments and possible movement
(see, for example, FIG. 50D).
[0220] 10. Disengage the retention latch 909b from the
decorticating rod mating feature 928, and remove the decorticating
rod 903a from the assembly (see, for example, FIG. 50D).
[0221] 11. Insert desired biologic and/or bony material 2406 into
the delivery shaft tool insertion end 904 (see, for example, FIG.
50E).
[0222] 12. Insert the plunging rod 903b through the delivery shaft
901, plunging the biologic towards the second end of the delivery
shaft 902 (see, for example, FIG. 50E).
[0223] 13. Once the plunging rod 903b is fully inserted, rotate the
upper retention latch 909b to engage it with the plunging rod
mating feature 928 (see, for example, FIG. 50F).
[0224] 14. Rotate the lower retention latch to unlock the delivery
sheath. Check fluoroscopy for delivery sheath position.
[0225] 15. Wrapping one's hand around the handle 908, and grasping
or handling the jut 921 on the delivery sheath. Pull and retract
the delivery sheath, leaving the biologic 2406 behind (see, for
example, FIG. 50F). Ensure the delivery shaft remains fixed in
space by pulling the jut 921/delivery sheath 902 relative to the
delivery shaft 901. The goal of this step is to ensure the delivery
shaft and biologic remain in the desired location as confirmed by
fluoroscopy, while the delivery sheath is moved out of the way.
[0226] This step differs from a method of using an instrument to
"push" the biologic out of the delivery sheath, and into an
unwanted location.
[0227] 16. Fluoroscopy confirmation step, ensure that the end of
the delivery sheath has moved from the most inferior/superior
pedicle screw to the most superior, or vice versa if access made
from the caudal approach. The delivery sheath should not be seen in
the same position as when the instrument was inserted.
[0228] 17. Remove assembly, and suture incision, if
appropriate.
EXAMPLE 2
[0229] In certain examples, the following exemplary steps are used
to access the intertransverse process area. In preferred
embodiments, the following steps are performed following surgical
procedures involving placement of percutaneous pedicle screws,
although in other embodiments, these steps may be performed prior
to or during such procedure. These steps are performed with certain
embodiments of a graft delivery assembly (e.g., FIGS. 51-53)
[0230] 1. Assemble instruments by placing a decorticating rod 952
through a graft delivery shaft 951, leaving space for preferred
biologic at the graft delivery end 959 of the graft delivery shaft,
choosing the desired volume using the volume markers 931.
[0231] 2. Place the retention lock or retention fastener 957 in a
locking position on the graft delivery shaft 951, to prevent
accidental expulsion of biologic
[0232] 3. Pack the graft delivery end 959 of graft delivery shaft
951 with preferred biologic, creating a tightly packed space.
[0233] 4. If an adequate incision has not already been created,
create a 1-2 cm incision approximately two to three levels cephalad
or caudal from the vertebral level requiring graft delivery (in
some cases, approximately 5 cm laterally from the spinous process).
In certain embodiments, medical practitioners may use a variety of
instruments (such as Jamshidi.RTM. needles, probes) to target the
intended levels.
[0234] 5. Insert an embodiment of the assembly 950 through the skin
incision, maneuvering the instruments so that the beveled end is
roughly aligned with the most inferior/superior pedicle screw,
lateral to pedicle screw or tower. The concavity of the instruments
should be directed out of the patient's skin.
[0235] 6. Observe fluoroscope from a lateral view to confirm
trajectory and placement of the instruments to the desired
vertebral level of interest.
[0236] 7. While handling the graft delivery shaft handle 954 and/or
grip 964a, and a decorticating rod handle 955 or plunging rod
handle 956, maneuver the instrument along the bony region of
interest in a rocking motion and a push-pull motion along the axis
of the spine to decorticate the bone. Once satisfied, unlock or
loosen the retention lock or retention fastener 957.
[0237] 8. While holding a handle 955, 956 and/or grip 964b in a
fixed position in space, grasp the shaft handle 954 and/or grip
964a and firmly pull the graft delivery shaft 951 upwards toward.
Ensure the decorticating rod or plunging rod handle remains fixed
in space by pulling the graft delivery shaft relative to the rod.
The goal of this step is to ensure the biologic remain in the
desired location as confirmed by fluoroscopy, while the delivery
shaft is moved out of the way.
[0238] 9. Fluoroscopy confirmation step, ensure that the end of the
delivery shaft has moved from the most inferior/superior pedicle
screw to the most superior, or vice versa if access made from the
caudal approach. The delivery shaft should not be seen in the same
position as when the instrument was inserted.
[0239] Remove assembly, and suture incision, if appropriate.
[0240] In certain embodiments, instruments, assemblies, parts,
portions, fasteners, and other features described herein may be
made of materials metallic, including, but not limited to,
biocompatible metals and alloys, such as titanium, tantalum,
stainless steels, gold, silver, cobalt, chromium, platinum,
ruthenium, rhodium, rhenium, and other alloys thereof, combinations
thereof, or other equivalent material intended to bridge one or
more transverse processes through utilization of the method steps
and apparatuses disclosed herein. Instruments, assemblies, parts,
portions, fasteners, and other features described herein may
describe polymers, including, but not limited to polymethyl
methacrylate (PMMA), polyetheretherketone (PEEK),
polymethymethacrylate (PMMA), polyglycolic acid and/or polylactic
acid compounds, polystyrene (PS), polyesters (PET, polycaprolacton,
polyglycolied, poylactide, poly-p-dixanone, poly-hydroxy-butylate),
polyvinylchloride (PVC), polyethylene (PE, HDPE, UHMWPE, etc.),
polyamides (Nylons, aromatic polyamides), polypropylene (PP),
fluorocarbon polymers (PTFE, PTFCE, PVF, FEP), polyphenylsulfones
(PPSU, e.g. Radel.RTM.), acetal copolymers, and other biocompatible
materials.
[0241] Certain embodiments of the invention are designed for use
with other spinal surgery procedures. It is appreciated that
embodiments of the inventions mentioned herein can be used before
or after other orthopedic procedures. For example, these orthopedic
procedures may include, but are not limited to: pedicle screw
placement, minimally invasive pedicle screw placement, minimally
invasive screw/rod systems, multi-level screw/rod systems,
scoliosis correction, posterior lumbar interbody fusion, anterior
lumbar interbody fusion, posterior lumbar interbdoy fusion,
transforaminal lumbar interbody fusion, oblique lumbar interbody
fusion, eXtreme Lateral Interbody Fusion.RTM., axial lumbar
interbody fusion, anterior cervical discectomy and fusion,
kyphoplasty, laminoplasty, laminotomy, sacroiliac fusion, and
others.
[0242] Due to the minimally invasive nature of the system and
instruments described, the procedures can be performed through the
same or similar openings used for other minimally invasive
procedures. In one use case, certain embodiments described herein
are used in conjunction with a minimally invasive pedicle screw/rod
system. A minimally invasive pedicle screw/rod system, as it is
commonly known, includes creating at least one incision to access
the pedicles of two or more adjacent vertebrae. It will be
appreciated that in certain embodiments, the instrumentation
described herein allows for depositing bony material through the
same incision as that of a minimally invasive pedicel screw/rod
system. In general, the present inventors have contemplated that by
minimizing the size of the required incisions for posterolateral
spinal fusion through use of the apparatuses and methods disclosed
herein, less trauma is introduced to the tissue, leading to, for
example, faster recovery and less complications.
[0243] The illustrations of arrangements described herein are
intended to provide a general understanding of the structure of
various embodiments, and they are not intended to serve as a
complete description of all the elements and features of apparatus
and systems that might make use of the structures described herein.
Many other arrangements will be apparent to those of skill in the
art upon reviewing the above description. Other arrangements may be
utilized and derived therefrom, such that structural and logical
substitutions and changes may be made without departing from the
scope of this disclosure. Figures are also merely representational
and may not be drawn to scale. Certain proportions thereof may be
exaggerated, while others may be minimized. Accordingly, the
specification and drawings are to be regarded in an illustrative
rather than a restrictive sense.
[0244] The preceding description has been presented with reference
to various embodiments. Persons skilled in the art and technology
to which this application pertains will appreciate that alterations
and changes in the described structures and methods of operation
can be practiced without meaningfully departing from the principle,
spirit and scope.
[0245] The present systems, methods, means, and enablement are not
limited to the particular systems and methodologies described, as
there can be multiple possible embodiments, which are not expressly
illustrated in the present disclosures. It is also to be understood
that the terminology used in the description is for the purpose of
describing the particular versions or embodiments only, and is not
intended to limit the scope of the present application.
[0246] Some embodiments, illustrating its features, will now be
discussed in detail. The words "comprising," "having,"
"containing," and "including," and other forms thereof, are
intended to be equivalent in meaning and be open ended in that an
item or items following any one of these words is not meant to be
an exhaustive listing of such item or items, or meant to be limited
to only the listed item or items. It must also be noted that as
used herein and in the appended claims, the singular forms "a,"
"an," and "the" include plural references unless the context
clearly dictates otherwise. The disclosed embodiments are merely
exemplary.
* * * * *