U.S. patent application number 11/760064 was filed with the patent office on 2007-10-04 for methods and devices for spinal fixation element placement.
This patent application is currently assigned to DEPUY SPINE, INC.. Invention is credited to David Greg Anderson, George Joseph Ross.
Application Number | 20070233097 11/760064 |
Document ID | / |
Family ID | 34654146 |
Filed Date | 2007-10-04 |
United States Patent
Application |
20070233097 |
Kind Code |
A1 |
Anderson; David Greg ; et
al. |
October 4, 2007 |
METHODS AND DEVICES FOR SPINAL FIXATION ELEMENT PLACEMENT
Abstract
Minimally invasive methods and devices are provided for
positioning a spinal fixation element in relation to adjacent
spinal anchors. In an exemplary embodiment, the device is a
percutaneous access device that can be coupled to a spinal anchor,
and the method includes the step of positioning a spinal fixation
element through at least one sidewall opening of at least two
percutaneous access devices such that the spinal fixation element
extends in a lengthwise orientation that is substantially
transverse to the longitudinal axis of each percutaneous access
device. The spinal fixation element can then be advanced in the
lengthwise orientation to seat the spinal fixation element in or
adjacent to the receiver heads of at least two adjacent spinal
anchors. A fastening element or other closure mechanism can then be
applied to each spinal anchor to engage the spinal fixation element
within the receiver heads of the adjacent anchors.
Inventors: |
Anderson; David Greg;
(Charlottesville, VA) ; Ross; George Joseph;
(Rehoboth, MA) |
Correspondence
Address: |
NUTTER MCCLENNEN & FISH LLP
WORLD TRADE CENTER WEST
155 SEAPORT BOULEVARD
BOSTON
MA
02210-2604
US
|
Assignee: |
DEPUY SPINE, INC.
325 Paramount Drive
Raynham
MA
02767-0350
|
Family ID: |
34654146 |
Appl. No.: |
11/760064 |
Filed: |
June 8, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10737537 |
Dec 16, 2003 |
|
|
|
11760064 |
Jun 8, 2007 |
|
|
|
Current U.S.
Class: |
606/86A |
Current CPC
Class: |
A61B 17/7079 20130101;
A61B 17/7082 20130101; A61B 17/7085 20130101; A61B 17/7002
20130101; A61B 17/7091 20130101 |
Class at
Publication: |
606/061 |
International
Class: |
A61B 17/58 20060101
A61B017/58 |
Claims
1-25. (canceled)
26. A tool set for implanting a spinal rod in a patient; said tool
set comprising: a) a pair of end guide tools; b) each of said end
guide tool being adapted to attach at a lower end thereof to a
respective spinal implant bone screw; and c) each of said end guide
tools including a longitudinal guide channel extending upwardly
from said lower end thereof; each of said channels being sized and
shaped to be adapted to receive opposite ends of the rod for
operably guiding the rod ends toward respective bone screws.
27. The tool set according to claim 26 wherein said tool set
further includes: a) at least one intermediate guide tool; b) each
of said intermediate guide tools including attachment structure
adapted for attachment to a respective bone screw; and c) each of
said intermediate guide tools including a longitudinal pass through
slot extending from a bottom thereof upward and being adapted to
receive therethrough and guide the rod to a bone screw attached to
a respective intermediate guide tool.
28. The tool set according to claim 26 wherein: a) said
longitudinal guide channel is part of an open pathway that extends
from near a bottom of a respective end guide tool to a top thereof;
said pathway opening radially outward along the entire length
thereof.
29. The tool set according to claim 28 wherein: a) each said end
guide tool has a cutout region between said longitudinal guide
channel and said guide tool lower end; said cutout being open in
the rear so as to define a pass through slot sized and shaped to be
adapted to allow passage therethrough of one end of the rod after
the rod has been guided to near a bone screw by said channel.
30. A bone screw and rod seating assembly comprising: a) a bone
screw having a shank for implanting in a bone and a head with a
channel adapted to receive a rod; b) said bone screw head including
a first attachment structure thereon; c) an elongate guide tool
having a radially outward facing channel extending parallel to an
axis thereof and upwardly from near a bottom of said guide tool;
said channel sized and shaped to receive a first end of a rod and
operably guide said rod first end to said bone screw head; said
guide tool being sized to partially extend above a patient's skin
so as to allow percutaneous manipulation of said guide tool by a
surgeon; and d) said guide tool bottom including a second
attachment structure thereon; said first and second attachment
structures being mateable to releaseably secure said guide tool to
said bone screw head.
31. A bone screw and rod seating assembly comprising: a) a bone
screw having a shank for implanting in a bone and a head with
channel adapted to receive a rod; b) said bone screw head including
a first attachment structure thereon; c) an elongate guide tool
having a radially pass through slot extending upwardly from near a
bottom thereof; said slot being sized and shaped to receive a rod
therethrough and operably guide said rod to said bone screw head;
said guide tool being sized to partially extend above a patient's
skin so as to allow percutaneous manipulation of said guide tool by
a surgeon; and d) said guide tool bottom including a second
attachment structure thereon; said first and second attachment
structures being mateable to releaseably secure said guide tool to
said bone screw head.
32. A tool set for implanting a spinal rod in a patient; said tool
set comprising: a) a pair of end guide tools; b) each of said end
guide tools being adapted to attach at a lower end thereof to a
respective spinal implant bone screw; and c) each of said end guide
tools including a longitudinal guide channel extending upwardly
from said lower end thereof; each of said channels being sized and
shaped to be adapted to receive opposite ends of the rod for
operably guiding the rod ends toward respective bone screws.
33. The tool set according to claim 32 wherein said tool set
further includes: a) at least one intermediate guide tool; b) each
of said intermediate guide tools including attachment structure
adapted for attachment to a respective bone screw; and c) each of
said intermediate guide tools including a longitudinal pass through
slot extending from a bottom thereof upward and being adapted to
receive therethrough and guide the rod to a bone screw attached to
a respective intermediate guide tool.
34. A bone screw and rod seating assembly comprising: a) a bone
screw having a shank for implanting in a bone and a head with a
channel adapted to receive a rod; b) said bone screw head including
a first attachment structure thereon; c) an elongate guide tool
having a radially outward facing channel extending parallel to an
axis thereof and upwardly from near a bottom of said guide tool;
said channel sized and shaped to receive a first end of a rod and
operably guide said rod first end to said bone screw head; said
guide tool being sized to partially extend above a patient's skin
so as to allow percutaneous manipulation of said guide tool by a
surgeon; and d) said guide tool bottom including a second
attachment structure thereon; said first and second attachment
structures being mateable to releaseably secure said guide tool to
said bone screw head.
35. A bone screw and rod seating assembly comprising: a) a bone
screw having a shank for implanting in a bone and a head with
channel adapted to receive a rod; b) said bone screw head including
a first attachment structure thereon; c) an elongate guide tool
having a radially pass through slot extending upwardly from near a
bottom thereof; said slot being sized and shaped to receive a rod
therethrough and operably guide said rod to said bone screw head;
said guide tool being sized to partially extend above a patient's
skin so as to allow percutaneous manipulation of said guide tool by
a surgeon; and d) said guide tool bottom including a second
attachment structure thereon; said first and second attachment
structures being mateable to releaseably secure said guide tool to
said bone screw head.
36. A tool for implanting spinal implants in a patient; said tool
comprising: a) said tool being adapted to attach at a lower end
thereof to a first spinal implant; and b) said tool including a
radially outwardly opening and longitudinal guide channel extending
the entire length thereof; said channel being sized and shaped to
be adapted to receive an end of a rod like second implant for
operably guiding the second implant toward said first implant.
37. The tool according to claim 36 including: a) a lower portion
that is sized and shaped to be located beneath a patient's skin
during use and an upper portion located outside of the patient
during use; and b) said lower portion having attachment structure
thereon adapted to removably attach said tool to said first
implant.
38. The tool according to claim 38 in combination with said first
implant.
39. The tool and implant combination according to claim 38 wherein:
a) said first implant is a bone screw.
40. The tool and implant according to claim 38 wherein: a) said
first implant is a hook.
41. The tool and implant combination according to claim 38 wherein:
a) said bone screw has an upper head with a rod receiving channel
therein; b) said attachment structure being configured to attach
said tool to said head such that said tool longitudinal channel
aligns with said head rod receiving channel, such that a rod
received in said tool channel is guided downwardly by said tool to
be received in said head tool receiving channel.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 10/737,537 filed on Dec. 16, 2003 and entitled
"Methods and Devices for Spinal Fixation Element Placement," which
is hereby incorporated by reference in its entirety.
FIELD OF THE INVENTION
[0002] This application relates to tools for use in spinal surgery,
and in particular to minimally invasive methods and devices for
introducing a spinal fixation element to one or more spinal anchor
sites within a patient's spine.
BACKGROUND OF THE INVENTION
[0003] For a number of known reasons, spinal fixation devices are
used in orthopedic surgery to align and/or fix a desired
relationship between adjacent vertebral bodies. Such devices
typically include a spinal fixation element, such as a relatively
rigid fixation rod, that is coupled to adjacent vertebrae by
attaching the element to various anchoring devices, such as hooks,
bolts, wires, or screws. The fixation elements can have a
predetermined contour that has been designed according to the
properties of the target implantation site, and once installed, the
instrument holds the vertebrae in a desired spatial relationship,
either until desired healing or spinal fusion has taken place, or
for some longer period of time.
[0004] Spinal fixation elements can be anchored to specific
portions of the vertebrae. Since each vertebra varies in shape and
size, a variety of anchoring devices have been developed to
facilitate engagement of a particular portion of the bone. Pedicle
screw assemblies, for example, have a shape and size that is
configured to engage pedicle bone. Such screws typically include a
threaded shank that is adapted to be threaded into a vertebra, and
a head portion having a rod-receiving element, usually in the form
of a U-shaped slot formed in the head. A set-screw, plug, or
similar type of fastening mechanism is used to lock the fixation
element, e.g., a spinal rod, into the rod-receiving head of the
pedicle screw. In use, the shank portion of each screw is threaded
into a vertebra, and once properly positioned, a rod is seated
through the rod-receiving member of each screw and the rod is
locked in place by tightening a cap or other fastener mechanism to
securely interconnect each screw and the fixation rod.
[0005] Recently, the trend in spinal surgery has been moving toward
providing minimally invasive devices and methods for implanting
spinal fixation devices. One such method, for example, is disclosed
in U.S. Pat. No. 6,530,929 of Justis et al. and it utilizes two
percutaneous access devices for implanting an anchoring device,
such as a spinal screw, into adjacent vertebrae. A spinal rod is
then introduced through a third incision a distance apart from the
percutaneous access sites, and the rod is transversely moved into
the rod-engaging portion of each spinal screw. The percutaneous
access devices can then be used to apply closure mechanisms to the
rod-engaging heads to lock the rod therein. While this procedure
offers advantages over prior art invasive techniques, the
transverse introduction of the rod can cause significant damage to
surrounding tissue and muscle. Moreover, the use of three separate
access sites can undesirably lengthen the surgical procedure, and
increase patient trauma and recovery time.
[0006] Accordingly, there remains a need for improved minimally
invasive devices and methods for introducing a spinal fixation
element into a patient's spine.
SUMMARY OF THE INVENTION
[0007] The present invention generally provides methods for
introducing a spinal fixation element into a receiver head of
adjacent spinal anchors. In one embodiment, the method utilizes at
least two percutaneous access devices, each of which has a proximal
end positioned outside a patient's body and a distal end coupled to
a spinal anchor. The access device preferably includes at least one
sidewall opening extending from the distal end through at least a
portion of the percutaneous access device. In use, a spinal
fixation element is positioned through the sidewall opening(s) in
at least two adjacent percutaneous access devices such that the
spinal fixation element extends in an orientation that is
substantially transverse to a longitudinal axis of each
percutaneous access device. The spinal fixation element is then
advanced in the substantially transverse orientation to seat the
spinal fixation element in or adjacent to the receiver head of at
least two spinal anchors that are preferably implanted within
adjacent vertebrae.
[0008] In an exemplary embodiment, each percutaneous access device
includes first and second opposed sidewall openings, and at least
one of the first and second sidewall openings extends from the
distal end and terminates at a position distal to the proximal end.
The percutaneous access devices can also optionally include a
cannula, sleeve, or similar device disposed therearound that is
effective to prevent removal of each percutaneous device from the
spinal anchor coupled thereto. The sleeve preferably includes at
least one sidewall opening formed therein that is adapted to align
with the at least one sidewall opening in the percutaneous access
device.
[0009] In another embodiment of the present invention, a
percutaneous access system for introducing a spinal fixation
element into a patient's body is provided. The system includes at
least two spinal anchors that are adapted to be disposed in bone,
at least one elongate, generally cylindrical hollow tube having at
least one sidewall opening extending from the distal end thereof
and terminating at a position distal to the proximal end, and a
spinal fixation element. The system can also include at least one
sleeve which is adapted to be slidably disposed around at least a
portion of one of the hollow tubes. The sleeve(s) preferably
includes at least one sidewall opening formed therein that is
adapted to align with the sidewall opening(s) formed in the hollow
tube. The system can also include a driver mechanism having a
proximal handle portion, and a distal end that is adapted to couple
to a spinal anchor such that rotation of the driver mechanism is
effective to thread the spinal anchor into bone. The driver
mechanism is preferably adapted to be disposed through the hollow
tube(s).
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1 is a perspective view of a percutaneous access device
coupled to a spinal anchor according to one embodiment of the
present invention;
[0011] FIG. 2 is a cross-sectional view taken along the
longitudinal axis L of the percutaneous access device shown in FIG.
1;
[0012] FIG. 3A is a posterior view of a midline incision formed in
the thoracolumbar fascia of a patient's back;
[0013] FIG. 3B is an end view showing a blunt dissection of the
muscles surrounding a patient's vertebra;
[0014] FIG. 4 is an end view of the vertebra shown in FIG. 3B
showing a technique for separating the muscles along the muscle
plane to gain access to the vertebra;
[0015] FIG. 5 is an end view of the vertebra shown in FIG. 4
showing placement of a k-wire through the incision and into the
patient's vertebra;
[0016] FIG. 6 is an end view of the vertebra shown in FIG. 5 having
an obturator and several dilators disposed over the k-wire to
dilate the tissue and muscles;
[0017] FIG. 7 is perspective view of a spinal anchor having a
percutaneous access device coupled thereto and extending through an
incision formed in the patient's tissue surface to implant the
spinal anchor in a vertebra;
[0018] FIG. 8 is a perspective view of two percutaneous access
devices attached to spinal anchors that are disposed within
adjacent vertebrae in a patient's spinal column;
[0019] FIG. 9 illustrates a method for introducing a spinal
fixation element through the percutaneous access devices shown in
FIG. 8;
[0020] FIG. 10 is a perspective view of the spinal fixation element
shown in FIG. 9 being advanced toward the spinal anchors using a
pusher device;
[0021] FIG. 11 is a perspective view of the spinal fixation element
shown in FIG. 10 after it is fully positioned within receiver heads
of the adjacent spinal anchors;
[0022] FIG. 12 is a perspective view of a compression tool
positioned around the percutaneous access devices shown in FIG. 11
and compressing the devices toward one another; and
[0023] FIG. 13 is a perspective view of a closure mechanism being
applied through one of the percutaneous access devices to lock the
spinal fixation element in relation to the spinal anchor.
DETAILED DESCRIPTION OF THE INVENTION
[0024] The present invention provides minimally invasive methods
and devices for introducing a spinal fixation element into a
surgical site in a patient's spinal column. In general, the method
involves positioning a spinal fixation element through openings
formed in at least two adjacent percutaneous access devices such
that the spinal fixation element extends between the at least two
adjacent percutaneous access devices in a lengthwise orientation.
The spinal fixation element can then be advanced in a distal
direction to seat the spinal fixation element in the receiver heads
of the adjacent spinal anchors, or to otherwise position the spinal
fixation element in relation to the adjacent spinal anchors. A
fastening element or other closure mechanism can optionally be
applied to each spinal anchor to engage the spinal fixation element
within the receiver heads of the adjacent anchors, or to otherwise
directly or indirectly connect the spinal fixation element to the
anchors.
[0025] While a variety of devices can be used to perform the
methods of the present invention, FIGS. 1 and 2 illustrate an
exemplary embodiment of a percutaneous access device 12 that is
mated to a spinal anchor 50 to form a spinal implant assembly 10.
The device 12 is in the form of a generally elongate, cylindrical
tube having an inner lumen 12c formed therein and defining a
longitudinal axis L that extends between proximal and distal ends
12a, 12b. The size of the access device 12 can vary depending on
the intended use, but it should have a length l that allows the
proximal end 12a of the access device 12 to be positioned outside
the patient's body, while the distal end 12b of the access device
12 is coupled to, or positioned adjacent to, a spinal anchor, e.g.,
anchor 50, that is disposed in a vertebra in a patient's spine. The
inner diameter d.sub.i of the access device 12 can also vary
depending on the intended use, but the inner diameter d.sub.i is
preferably sufficient to accommodate a diameter or width of a
spinal fixation element to be introduced therethrough.
[0026] The percutaneous access device 12 also preferably includes
at least one sidewall opening or slot 14, and more preferably two
opposed sidewall openings (only one opening 14 is shown), formed
therein and extending proximally from the distal end 12b thereof.
The openings 14 allow a spinal fixation element to be positioned
lengthwise between two adjacent devices 12 such that the spinal
fixation element extends in an orientation that is substantially
transverse to the longitudinal axis L of the access devices 12,
i.e., that crosses the longitudinal axis L of the access devices
12. The exact position of the spinal fixation element with respect
to the longitudinal axis L will of course vary depending on the
configuration of the spinal fixation element. The shape and size of
the openings 14 can also vary depending on the configuration of the
spinal fixation element, but the openings 14 preferably have a
generally elongate shape with a width w that is sufficient to
accommodate the diameter of the spinal fixation element. The
openings 14 preferably extend over about half of the length, or
more than half of the length, of the percutaneous access device 12.
This allows a proximal portion of each opening 14 to be positioned
outside a patient's body while the device 12 is in use, thus
allowing a spinal fixation element to be externally positioned
through the openings 14 and then moved distally to be implanted. A
person skilled in the art will appreciate that the percutaneous
access device 12 can include any number of sidewall openings having
any shape that is sufficient to allow a spinal fixation element to
be positioned therethrough.
[0027] Continuing to refer to FIG. 1, in use, the percutaneous
access device 12 is preferably adapted to attach to a spinal anchor
50, and more preferably to the receiver head 52 of a spinal anchor
50. Accordingly, the distal end 12c of the percutaneous access
device 12 can include one or more mating elements 18 formed thereon
or therein for engaging the spinal anchor 50. Suitable mating
elements include, for example, threads, a twist-lock engagement, a
snap-on engagement, or any other technique known in the art, and in
an exemplary embodiment the mating elements are formed on opposed
inner surfaces of the distal end 12b of the access device 12. A
sleeve (not shown) or other device, preferably having sidewall
openings that correspond with the sidewall openings 14 formed in
the percutaneous access device 12, can also be placed over the
percutaneous access device 12, and optionally over the anchor 50 as
well, to prevent disengagement of the access device 12 from the
anchor 50 during use. Exemplary techniques for mating the
percutaneous access device 12 to a spinal anchor are disclosed in a
patent application entitled "Percutaneous Access Devices and Bone
Anchor Assemblies," filed concurrently herewith. A person skilled
in the art will appreciate that a variety of other techniques can
be used to removably mate the percutaneous access device to a
spinal anchor.
[0028] Still referring to FIG. 1, an exemplary spinal anchor for
use with the methods and devices of the present invention is shown.
A person skilled in the art will appreciate that a variety of
implants can be used with the devices and methods of the present
invention, including, for example, spinal screws, hooks, bolts, and
wires. By way of non-limiting example, FIG. 1 illustrates a spinal
screw 50 that includes a distal, bone-engaging portion, e.g., a
threaded shank 54, and a proximal, U-shaped, receiver head 52 that
is adapted to seat a spinal fixation element, such as a spinal rod
(not shown). The threaded shank 54 can be fixedly attached to the
receiver head 52 to form a monoaxial screw, or alternatively the
shank 54 can be configured as a polyaxial screw, as shown, that is
rotatably disposed through an opening formed in the distal end of
the receiver head 52 to allow rotation of the shank 54 with respect
to the receiver head 52. A variety of techniques can be used to
allow rotation of the head 52 with respect to the shank 54.
[0029] FIGS. 3A-13 show a minimally invasive method of implanting a
spinal fixation element into the receiver heads of adjacent spinal
anchors. While the method is shown and described in connection with
the percutaneous access device 12 and spinal screw 50 disclosed
herein, a person skilled in the art will appreciate that the method
is not limited to use with such devices, and that a variety of
other devices known in the art can be used. Moreover, while only
two access devices 12, 12' and two implants 50, 50' are shown in
FIGS. 8-13, the method of the present invention can be performed
using any number of access devices and spinal anchors. The method
can also be performed using only some of the method steps disclosed
herein, and/or using other methods known in the art.
[0030] The procedure preferably begins by forming an incision
through the tissue located adjacent to the desired implant site.
While the location, shape, and size of the incision will depend on
the type and quantity of spinal anchors being implanted, FIG. 3A
illustrates a midline, blunt dissection incision 62 formed in the
thoracolumbar fascia in the patient's back along the muscle plane.
The length of the incision 62 is about 4-5 cm, however this can
vary depending on the procedure. Once the midline incision 62 is
formed, blunt finger dissection can be used, as shown in FIG. 4, to
separate the longissimus thoracis and multifidus muscles, thereby
exposing the facet and the junction of the transverse process and
superior articular process.
[0031] As shown in FIG. 5, a guide wire, e.g., a k-wire 64, can be
implanted, either prior to or after formation of the incision, at
each spinal anchor implant site. The k-wire 64 preferably extends
between the muscles and into the vertebra at the desired entry
point of the spinal anchor. Fluoroscopy is typically used to
facilitate proper placement of the k-wire 64.
[0032] The opposed ends of the incision can then be dilated to
provide a pathway for delivery of a spinal anchor to each implant
site. FIG. 6 illustrates dilation at one end of the incision 62
using an obturator 66a having several dilators 66b, 66c of
increasing size placed there over. The dilators 66b, 66c are
delivered over the obturator 66a and k-wire 64 to essentially
stretch the skin around the incision 62 and to expand the pathway
to the anchor site. While not illustrated, a person skilled in the
art will appreciate that the incision 62 can optionally be held
opening using a retractor or an expandable cannula.
[0033] Once the incision 62 is dilated to the proper size, an
anchor can be delivered to each anchor site, as shown in FIG. 7.
This procedure typically involves preparation of the vertebra 60
using one or more bone preparation instruments, such as drills,
taps, awls, burrs, probes, etc. While not always necessary, one or
more cannulae can be used to provide a pathway from the incision 62
to the anchor site for insertion of the bone preparation
instruments and/or the anchor. In an exemplary embodiment, a
relatively small cannula is used to introduce bone preparation
instruments into the surgical site. The incision 62 can then be
further dilated, and the small cannula can be replaced with a
larger cannula that is adapted to receive or mate to the
anchor.
[0034] Once the vertebra 60 is prepared, a spinal anchor can be
implanted at each implant site. An access device 12, 12' can be
mated to each anchor 50, 50' after insertion of the anchor 50, 50'
into bone 60, 60', but more preferably each percutaneous access
device 12, 12' is attached to the anchor 50, 50' prior to insertion
of the anchor 50, 50' into bone 60, 60' to provide a passageway for
a driver tool for driving the anchor 50 into bone 60, 60'. FIG. 7
illustrates anchor 50 implanted in a first vertebra 60 and having
access device 12 attached thereto. While not shown, the anchor 50
is preferably cannulated to allow the k-wire 64 to extend through
the anchor 50 and the access device 12 to guide the devices 50, 12
toward the implant site. FIG. 7 further illustrates a second anchor
50' having an access device 12' mated thereto. As shown, the screw
50' is about to be implanted in a second vertebra 60' that is
adjacent to the first vertebra 60. Once the screw 50' is positioned
adjacent to the vertebra 60', a driver tool 200 can be positioned
through the access device 12' and coupled to the receiver head 52'
of the screw 50' to drive the screw 50' into the vertebra 60'.
[0035] In another embodiment, a sleeve can be placed over each
access device 12, 12', either prior to or after the devices 12,
12', 50, 50' are implanted, to prevent the devices 12, 12' from
becoming disengaged from the anchors 50, 50' to which they are
attached. The sleeve 100, which is partially illustrated in FIG.
3B, is preferably in the form of a cannula that has substantially
the same configuration as each access device 12, 12'. The use of a
sleeve is particularly desirable where the access devices 12, 12'
utilize pin members that engage corresponding detents formed on an
outer surface of each screw head 52, 52', as the sleeve will
prevent the pin members from becoming disengaged from the detents.
The sleeve can also optionally serve as an access device, allowing
access devices 12, 12' to be detached and removed from the anchors
50, 50'.
[0036] After the anchors are implanted, as shown in FIG. 8, a
spinal fixation element is delivered to the anchor sites. As shown
in FIG. 9, the spinal fixation element 70 is positioned through the
openings 14, 14' in the adjacent devices 12, 12' such that the
spinal fixation element 70 extends in a lengthwise orientation
which is substantially transverse to the longitudinal axis L of the
access devices 12, 12'. The exact angle of the fixation element 70
with respect to the percutaneous access devices 12, 12' will vary
depending on the orientation of the access device 12, 12' with
respect to the patient's spinal column, and it is understood that
the orientation can vary during use since the percutaneous access
devices 12, 12' can be oriented at various angles throughout the
surgical procedure.
[0037] The spinal fixation element 70 is then moved distally toward
the distal end 12b, 12b' of the percutaneous access devices 12,
12'. As the spinal fixation element 70 moves distally, it will
advantageously pass between the muscles, thus eliminating the need
to cut or tear tissue. The method is also particularly advantageous
in that the percutaneous access devices 12, 12' direct the spinal
fixation element 70 into the receiver heads 52, 52' of the adjacent
spinal anchors 50, 50', thus allowing the spinal fixation element
to be properly positioned without the necessity for direct visual
access to the surgical site.
[0038] Movement of the spinal fixation element 70 in the distal
direction can be achieved using pusher shaft 80, as shown in FIGS.
10 and 11. The pusher shaft 80 can have a variety of
configurations, but it should be effective to allow controlled
movement of the spinal fixation element 70. A person skilled in the
art will appreciate that a variety of other techniques can be used
to advance the spinal fixation element 70 distally between the
percutaneous access devices 12, 12' to seat the spinal fixation
element 70 into the receiver heads 52, 52' of adjacent spinal
anchors 50, 50'. In the illustrated embodiment, the pusher shaft 80
includes a seating member 82 formed on a distal end thereof that is
adapted to seat the spinal fixation element 70. The seating member
82, which is similar to a receiver head of a spinal anchor, is
generally cylindrical and includes an open distal end with opposed
U-shaped cut-out portions formed therein for receiving the spinal
fixation element 70. In use, the seating member 82 is positioned
around the spinal fixation element 70 and a force is applied to the
pusher shaft 80 to move the spinal fixation element 70
distally.
[0039] Once the spinal fixation element 70 is fully seated in the
receiver heads 52, 52' of the adjacent spinal anchors 50, 50', as
shown in FIG. 11, the pusher shaft 80, if used, can then be removed
or detached from the spinal fixation element 70, and a closure
mechanism can be applied to one or both receiver heads 52, 52' to
retain the spinal fixation element 70 therein. In an exemplary
embodiment, however, a compression tool 100 is used to compress the
access devices 12, 12' toward one another prior to applying a
closure mechanism to each anchor 50, 50'. The closure mechanism(s)
can, however, be partially applied before compression.
[0040] An exemplary compression tool 100 is shown in FIG. 12, and
in general it includes opposed arms 102, 104 that are pivotally
coupled to one another at a substantial mid-point thereof such that
each arm 102, 104 includes a distal portion 102b, 104b that is
adapted to be disposed around a percutaneous access device 12, 12',
and a proximal, handle portion 102a, 104a. The device 100 can also
include a fulcrum (not shown) that is disposed between the arms
102, 104 to facilitate controlled movement of the arms 102, 104
with respect to one another. In use, the distal portion 102b, 104b
of each arm 102, 104 is placed around an access device 12, 12',
preferably around the distal end 12b, 12b' of each device 12, 12'
and/or around the head 52, 52' of each anchor 50, 50'. The
proximal, handle portions 102a, 104a are then brought toward one
another to move the access devices 12, 12' toward one another,
preferably while maintaining relative spacing therebetween, as
shown in FIG. 12.
[0041] Once properly positioned, a closure mechanism can be
applied, preferably via the access devices 12, 12', to each anchor
head 50, 50' to retain the spinal fixation element 70 within the
receiver heads 52, 52'. A variety of closure mechanisms and tools
for delivering closure mechanisms are known in the art and they can
be used with the present invention. By way of non-limiting example,
FIG. 13 illustrates a driver tool 90 disposed through access device
12 for applying a closure mechanism, such as a set screw, to the
receiver head 52 of the spinal anchor 50 to lock the spinal
fixation element 70 with respect to the spinal anchor 50. This step
can be repeated for the adjacent spinal anchor(s).
[0042] A person skilled in the art will appreciate that the spinal
fixation element 70 does not need to be directly attached to each
anchor 50, 50', and that it can be indirectly attached to the
anchors 50, 50' using, for example, a band clamp, or slotted or
offset connectors.
[0043] Once the fixation element 70 is secured in relation to the
implants 50, 50', the access devices 12, 12' can be removed (if
attached) from the implants 50, 50', leaving only a single,
relatively small incision in the patient where each access device
12, 12' and the spinal fixation element 70 was introduced. This is
particularly advantageous in that it reduces the amount of trauma
caused to the patient, and it minimizes the damage to muscle
surrounding the surgical site.
[0044] As previously stated, a person skilled in the art will
appreciate that the method can be performed in any sequence using
any of the steps. Moreover, the access devices of the present
invention can be used to deliver multiple spinal fixation elements
simultaneously or sequentially, and/or to perform a variety of
other surgical procedures not illustrated or described herein.
[0045] One skilled in the art will appreciate further features and
advantages of the invention based on the above-described
embodiments. Accordingly, the invention is not to be limited by
what has been particularly shown and described, except as indicated
by the appended claims. All publications and references cited
herein are expressly incorporated herein by reference in their
entirety.
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