U.S. patent number RE47,377 [Application Number 14/995,435] was granted by the patent office on 2019-05-07 for method and associated instrumentation for installation of spinal dynamic stabilization system.
This patent grant is currently assigned to Zimmer Spine, Inc.. The grantee listed for this patent is Zimmer Spine, Inc.. Invention is credited to Thomas J Gisel, Hugh D Hestad, Mark J Kroll, Mark W. Rice.
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United States Patent |
RE47,377 |
Rice , et al. |
May 7, 2019 |
Method and associated instrumentation for installation of spinal
dynamic stabilization system
Abstract
In one embodiment, a spinal stabilization apparatus includes a
vertebral anchor having a head portion and a bone attachment
portion. An elongate, flexible guide is removably coupled to the
head portion of the vertebral anchor and has a channel extending
longitudinally thereof and communicating with a slot in the head
portion of the anchor. An elongate cord may be received within the
channel to facilitate inserting and securing a spacer between pairs
of anchors installed into adjacent vertebrae of a person's
spine.
Inventors: |
Rice; Mark W. (Minneapolis,
MN), Gisel; Thomas J (Chaska, MN), Hestad; Hugh D
(Edina, MN), Kroll; Mark J (St. Paul, MN) |
Applicant: |
Name |
City |
State |
Country |
Type |
Zimmer Spine, Inc. |
Edina |
MN |
US |
|
|
Assignee: |
Zimmer Spine, Inc. (Edina,
MN)
|
Family
ID: |
39873026 |
Appl.
No.: |
14/995,435 |
Filed: |
January 14, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
11737151 |
Apr 19, 2007 |
7922725 |
|
|
Reissue of: |
13048447 |
Mar 15, 2011 |
8632572 |
Jan 21, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B
17/7085 (20130101); A61B 17/8869 (20130101); A61B
17/7083 (20130101); A61B 17/7031 (20130101); A61B
17/7085 (20130101); A61B 17/7008 (20130101) |
Current International
Class: |
A61B
17/70 (20060101) |
Field of
Search: |
;606/279,86A,263,270 |
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|
Primary Examiner: Flanagan; Beverly M
Attorney, Agent or Firm: Schwegman Lundberg & Woessner,
P.A.
Parent Case Text
REFERENCE TO RELATED APPLICATIONS
.[.This application.]. .Iadd.More than one application has been
filed for the reissue of U.S. Pat. No. 8,632,572. The reissue
applications are U.S. application Ser. No. 14/995,435 (the present
application) and U.S. application Ser. No. 15/619,948, filed on
Jun. 12, 2017, all of which are divisional reissues of U.S. Pat.
No. 8,632,572. The present application is a reissue of U.S.
application Ser. No. 13/048,447, filed on Mar. 15, 2011, now U.S.
Pat. No. 8,632,572, which .Iaddend.is a continuation of U.S. patent
application Ser. No. 11/737,151, filed Apr. 19, 2007, now U.S. Pat.
No. 7,922,725 B2, which is incorporated herein by reference.
Claims
What is claimed is:
1. A method of installing a spinal stabilization construct,
comprising: installing first and second vertebral anchors onto
first and second vertebrae, respectively, each vertebral anchor
having an upwardly open channel adapted to receive a flexible
connecting element extending between the first and second
vertebrae; mounting first and second access members onto the first
and second vertebral anchors, respectively, each access member
having a cannula to provide access to the channel of the respective
vertebral anchor; inserting the connecting element through a slot
in the first access member; advancing the flexible connecting
element from the slot in the first access member into the channel
of the first vertebral anchor; securing the flexible connecting
element .[.to.]. .Iadd.within .Iaddend.the channel of the first
vertebral anchor with a first fastener; positioning a spacer on the
connecting element adjacent the first vertebral anchor; inserting
the flexible connecting element through a slot in the second access
member; translating a tool along an exterior of the second access
member without rotation to advance the flexible connecting element
along the slot in the second access member into the channel in the
second vertebral anchor; positioning the spacer between the
vertebral anchors; and securing the flexible connecting element
.[.to.]. .Iadd.within .Iaddend.the channel of the second vertebral
anchor with a second fastener.
2. The method of claim 1, wherein positioning the spacer between
the vertebral anchors includes: pushing the spacer into position
between the vertebral anchors with the tool.
3. The method of claim 2, wherein the tool includes a lateral
portion extending transverse to a longitudinal axis of the tool for
contacting the spacer.
4. The method of claim 3, wherein the lateral portion is a flange
including an arcuate surface.
5. The method of claim 4, wherein the arcuate surface contacts an
outer surface of the spacer.
6. The method of claim 1, wherein the tool is a tubular member
slidably disposed around the second access member.
7. The method of claim 1, further comprising: tensioning the
connecting element after securing the flexible connecting element
to the channel of the first vertebral anchor and prior to securing
the flexible connecting element to the channel of the second
vertebral anchor.
8. The method of claim 1, further comprising: distracting the first
and second vertebrae during positioning of the spacer between the
vertebral anchors.
9. The method of claim 1, wherein securing the flexible connecting
element to the channel of the first vertebral anchor with the first
fastener includes passing the first fastener through the first
access member percutaneously to the first vertebral anchor, and
securing the flexible connecting element to the channel of the
second vertebral anchor with the second fastener includes passing
the second fastener through the second access member percutaneously
to the second vertebral anchor.
.Iadd.10. A method for performing spinal stabilization surgery,
comprising: creating at least one access opening in a patient;
implanting, through the at least one access opening, a plurality of
vertebral anchors into a plurality of corresponding vertebrae, each
vertebral anchor having an upwardly open channel defined between
upwardly directed arms, the channel configured to receive a
flexible cord in a top loading manner; top loading the cord into
the channel of a first vertebral anchor of the plurality of
vertebral anchors using a cord guide tool having a cord guide
feature and a vertebral anchor feature; securing a first end
portion of the cord to the first vertebral anchor; engaging a
second vertebral anchor of the plurality of vertebral anchors with
the cord guide tool through the at least one access opening; using
the cord guide tool to advance the cord distally into the channel
of the second vertebral anchor subsequent to engagement with the
second vertebral anchor and prior to fixation of the cord in the
second vertebral anchor; engaging a tensioning tool to the cord
guide tool; translating the second vertebral anchor implanted into
a second vertebra relative to the first vertebral anchor implanted
into a first vertebra using vertebral anchor feature of the cord
guide tool; applying a tension to the cord using the tensioning
tool; and securing the cord to the second vertebral anchor by
rotating a set screw into securement in the channel of the second
vertebral anchor with a driver; wherein the securing step is
performed while the cord guide tool is engaged with the second
vertebral anchor at the vertebral anchor feature after being slid
over an access tool coupled to the second vertebral
anchor..Iaddend.
.Iadd.11. The method of claim 10, further comprising: positioning
the driver through a lumen of the cord guide tool to rotate the set
screw..Iaddend.
.Iadd.12. The method of claim 11, wherein the tensioning tool is
engaged at a proximal end region of the cord guide tool and the
cord passes through an opening in the cord guide tool at least
partially defining the cord guide feature to reach the tensioning
tool..Iaddend.
.Iadd.13. The method of claim 12, wherein the driver is positioned
in the lumen of the cord guide tool while the tensioning tool is
engaged at a proximal end region of the cord guide
tool..Iaddend.
.Iadd.14. The method of claim 13, wherein the tensioning tool is
offset from the lumen of the cord guide..Iaddend.
.Iadd.15. The method of claim 10, wherein a portion of the cord
extends from the second vertebral anchor to the tensioning
tool..Iaddend.
.Iadd.16. A method for performing spinal stabilization surgery,
comprising: implanting first and second vertebral anchors into
first and second vertebral bodies, respectively, each vertebral
anchor having an upwardly open channel defined between upwardly
directed arms, the channel configured to receive a flexible cord in
a top loading manner; advancing the cord distally into the channel
the first vertebral anchor; securing a first end portion of the
cord to the first vertebral anchor; engaging the second vertebral
anchor with a cord guide tool; using the cord guide tool to both
advance the cord distally into the channel of the second vertebral
anchor with a cord guide feature and translate the second vertebral
anchor relative to the first vertebral anchor with a vertebral
anchor feature prior to fixation of the cord in the second
vertebral anchor, wherein translating the second vertebral anchor
involves application of force to the cord guide tool to manipulate
the position of the second vertebral body; engaging a tensioning
tool to a proximal end of the cord guide tool; applying a tension
to the cord using the tensioning tool; positioning a driver through
a lumen of the cord guide tool; and securing the cord to the second
vertebral anchor while the cord guide tool is engaged with the
second vertebral anchor at the vertebral anchor feature after being
slid over an access tool coupled to the second vertebral
anchor..Iaddend.
.Iadd.17. The method of claim 16, wherein the driver is positioned
in the lumen of the cord guide tool while the tensioning tool is
engaged with the cord guide tool..Iaddend.
.Iadd.18. The method of claim 17, wherein the tensioning tool is
offset from the lumen of the cord guide tool..Iaddend.
.Iadd.19. The method of claim 18, wherein a portion of the cord
extends from the second vertebral anchor to the tensioning
tool..Iaddend.
Description
TECHNICAL FIELD
This invention relates generally to spinal support devices, and
more particularly to methods and devices that facilitate installing
an implantable system for providing dynamic stability of a person's
spine.
BACKGROUND OF THE INVENTION
The treatment of acute and chronic spinal instabilities or
deformities of the thoracic, lumbar, and sacral spine has
traditionally involved the implantation of rigid rods to secure the
vertebrae of a patient. More recently, flexible materials have been
utilized in connection with securing elements, such as pedicle
screws, to provide a dynamic stabilization of the spine. Such
dynamic stabilization systems typically include a flexible spacer
positioned between pedicle screws installed in adjacent vertebrae
of a person's spine. Once the spacer is positioned between the
pedicle screws, a flexible cord is threaded through eyelets formed
in the pedicle screws and an aperture through the spacer. The
flexible cord retains the spacer between the pedicle screws while
cooperating with the spacer to permit mobility of the spine.
Traditional implantation of such dynamic stabilization systems may
require relatively large surgical sites to permit threading the
cord through the screws and spacer once the spacer has been
positioned between the screws.
While some dynamic stabilization systems have been proposed for
permitting the top loading of a spacer and cord between pedicle
screws, these systems also require added instrumentation and
procedures to distract the pedicle screws for placement of the
spacer.
A need therefore exists for a spinal dynamic stabilization system
and associated installation tools and techniques that overcome
these and other drawbacks of the prior art.
SUMMARY OF THE INVENTION
This invention overcomes the foregoing and other short-comings and
drawbacks of spinal stabilization systems heretofore known for use
in suitable various commercial and industrial environments. While
various embodiments will be described herein, the invention is not
limited to these embodiments. On the contrary, the invention
includes all alternatives, modifications and equivalents as may be
included within the spirit and scope of this invention.
In one embodiment, a system for stabilizing a patient's spine
includes a pair of vertebral anchors adapted to be anchored to
first and second vertebrae, respectively. Each vertebral anchor has
an upwardly open channel. A connecting element that may be in the
form of a flexible cord extends between the vertebral anchors and
is seated in the channels. An annular spacer is positioned between
the channels of the vertebral anchors with the connecting element
passing there through. A pair of fasteners is each mated with the
one of the channels of the vertebral anchors to secure the
connecting element thereto. A pair of access members in the form of
sleeves is mounted on the vertebral anchors and each sleeve has a
cannula to provide percutaneous access to the vertebral anchor when
mounted thereon.
A slot in each of the sleeves is in communication with the
associated channel when mounted on the vertebral anchor. The system
includes one tool having a tubular member with a cannula extending
there through and configured to fit over one of the sleeves when
mounted on the associated vertebral anchor. The tool is used by the
surgeon to advance the connecting member along the slot and into
the channel of one of the vertebral anchors and to position the
spacer between the vertebral anchors. In alternative embodiments,
the tool may have an arcuate flange on its distal end to cradle the
spacer for distraction during insertion between the vertebral
anchors.
The system may include another tool also having a tubular member
with a cannula extending there through and configured to fit over
one of the sleeves when mounted on the associated vertebral anchor.
This tool is adapted to advance the connecting member along the
slot and into the channel of the vertebral anchors. This tool may
include a mating feature proximate the distal end and complementary
to a mating feature on either the vertebral anchor or the sleeve to
thereby couple the tool thereto. The complementary mating features
may include a recess on the distal end of the tool, a recess on the
head of the pedicle screw, an outwardly directed protrusion
proximate a distal end of the sleeve, and an inwardly directed
protrusion proximate the distal end of the sleeve. The recesses are
configured to mate with the protrusions to releasably secure the
tool to the pedicle screw and allow the surgeon to use the tool to
screw the pedicle screws into the vertebrae.
Other embodiments of this invention involve the installation
procedures for a spinal stabilization construct and include
installing the vertebral anchors onto the vertebrae and mounting
access members, which in one embodiment are sleeves, onto the
vertebral anchors. Each sleeve has a cannula to provide
percutaneous access to the channel of the respective vertebral
anchor. The connecting element is inserted through a slot in one of
the sleeves and is advanced from the slot into the channel in the
associated vertebral anchor. The connecting element is secured to
the channel of the vertebral anchor with a fastener and an annular
spacer is positioned on the connecting element adjacent the
vertebral anchor.
The connecting element is inserted through a slot in the other
sleeve and advanced into the channel in the second vertebral
anchor. The spacer distracts against the first vertebral anchor and
positions the spacer between the vertebral anchors. The connecting
element is secured to the channel of the second vertebral anchor
with a second fastener. The connecting element may be a flexible
cord that is tensioned between the vertebral anchors. The
respective fasteners may be passed through the sleeves
percutaneously to the respective channels in conjunction with the
tensioning of the cord or connecting element.
These and other features, objects and advantages of the invention
will become more readily apparent to those skilled in the art in
view of the following detailed description, taken in conjunction
with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
The accompanying drawings, which are incorporated in and constitute
a part of this specification, illustrate embodiments of the
invention and, together with the general description of the
invention given above, and the detailed description given below,
serve to explain the principles of the invention.
FIG. 1 is a perspective view of a vertebral anchor in the form of a
pedicle screw and an associated fastener in the form of a set screw
according to one aspect of this invention;
FIG. 2 is a perspective view of the vertebral anchor of FIG. 1
being coupled to an access sleeve according to one aspect of this
invention;
FIG. 3 is a perspective view of the components of FIG. 2 being
coupled to a tool according to another aspect of this
invention;
FIG. 4 is a perspective view of the components of FIG. 3 being used
to screw a first vertebral anchor into a vertebra of a patient;
FIG. 5 is a perspective view of a connecting element of a dynamic
stabilization system being installed on the first vertebral anchor
of FIG. 4;
FIG. 6 is a perspective view of the components of the dynamic
stabilization system being installed relative to a pair of
vertebral anchors installed on respective vertebrae of the patient;
and
FIG. 7 is a perspective view of the connecting element of the
dynamic stabilization system being tensioned between the vertebral
anchors and the anchors being distracted during the tensioning
process.
DETAILED DESCRIPTION
FIGS. 1-2 and 6-7 depict some of the components of one embodiment
of a spinal stabilization system 10 according to this invention.
Specifically, vertebral anchors 12 are adapted to be installed into
adjacent vertebrae 14,16 of the spine using removable access
members 18 inserted through an incision formed through the
patient's skin. The incision may be sized for minimally invasive
percutaneous or retractor based techniques or may be used in open
procedures. In the embodiment shown, at least two anchors 12, shown
here in the form of pedicle screws, are fixedly installed into the
pedicle area of adjacent vertebrae 14,16 and a flexible spacer 20
is disposed there between to control motion of the spine, while
otherwise leaving the spinal segment mobile. Alternatively, the two
anchors can be placed in a patient in combination with a fusion
device located between the vertebral bodies.
The spacer 20 and pedicle screws 12 are coupled together by a
connecting element 22 which in one embodiment is a flexible member
coupled to or passed through the spacer 20 and secured to the heads
24 of the screws 12. Such spacers 20 and flexible members 22 may be
similar to those used in the Dynesys.RTM. Dynamic Stabilization
System available from Zimmer Spine of Minneapolis, Minn. In one
embodiment, the spacer 20 may be formed from polycarbonate urethane
and the flexible member 22 is a cord that may be formed from
polyethylene-terephthalate, although it will be recognized that
various other materials suitable for implantation within the human
body and for providing stabilization of the spine while maintaining
flexibility may be used.
In one embodiment, the anchor 12 is a pedicle screw having a
threaded shank 26 configured to be screwed into the pedicle area of
a vertebra 14,16. The head 24 of the screw is configured to receive
and secure the flexible member 22. In the embodiment shown, the
head 24 includes an upwardly open channel 28 formed between
upwardly directed arms 30 and extending generally transverse to the
longitudinal axis of the shank 26 and having an open end opposite
the shank 26 for receiving the flexible member 22 into the channel
28 of the head 24 in a top loading fashion. Accordingly, the
channel 28 alleviates the need to thread the flexible member 22
through an eyelet of the head 24 of the anchor 12 after the anchor
12 has been installed into the vertebral body 14, 16 of a patient's
spine. The head 24 may have a pair of spaced, generally flat faces
33 for juxtaposition to the spacer 20.
In this embodiment, the head 24 of the pedicle screw 12 has
receiving channels, such as recesses 32, provided on oppositely
disposed sides of the arms 30 of the head 24 to facilitate screwing
the anchor 12 into a vertebra 14,16 of a patient's spine using a
tool as described later herein. In one embodiment, the pedicle
screw 12 is formed from a titanium alloy, but it will be recognized
that various other materials suitable for implantation within the
human body and having sufficient strength to be securely attached
to the bone and to secure the flexible member 22 may be used. While
a uniaxial pedicle screw is shown and described herein, it will be
recognized that the anchor 12 may alternatively comprise a hook, a
polyaxial pedicle screw, or various other structure suitable to be
secured to a vertebral body.
An elongate access member 18 is removably secured to the head 24 of
the pedicle screw 12 and is formed substantially from a resilient,
flexible material that permits deformation or bending of the access
member 18 along its length without transmitting significant force
to the pedicle screw 12. For example, the access member 18 may be
formed from polymeric material such as nylon, polyethylene,
polyurethane, or various other polymeric materials that are
biocompatible and provide sufficient flexibility to permit the
guides to bend in flexure along their length without transmitting
significant force to the pedicle screw 12. In other exemplary
embodiments, the access members 18 may be configured as a rigid or
a composite structure, comprising a portion formed from a
substantially rigid material and a portion comprising a flexible
material or wholly of a rigid material.
In the embodiment shown in FIG. 2, the access member 18 includes a
pair of diametrically opposed, longitudinal slots 34 extending from
a first, distal end 36 toward a second, proximal end 38 of the
access member 18. Each slot 34 has an opening 40 at the first end
36 that is shaped to mate with the head 24 of the pedicle screw 12
such that the slot 34 communicates with the channel 28 formed in
the head 24 of the pedicle screw 12. In this arrangement, the
longitudinally extending slot 34 may be used to guide the flexible
member 22 from the slots 34 of the access member 18, along its
length, and into the channel 28 formed in the head 24 of the
pedicle screw 12.
In one embodiment, the access member 18 includes mating tabs 42 to
mate with the receiving channels or recesses 32 on the head 24 of
the pedicle screw 12. In the exemplary embodiment shown, the mating
tabs 42 are inwardly directed protrusions. Mating surfaces between
the pedicle screw and the access member 18 are configured to
provide a mechanical interlock that is sufficient to withstand
forces applied to the access member 18 during installation of the
pedicle screws 12 into the vertebrae 14,16 and installation of the
spacer 20 between adjacent pedicle screws 12. However, the access
members 18 may be removed from the heads 24 of the pedicle screws
12, for example, by application of an appropriate force or by
manipulating the access member 18 relative to the pedicle screw 12,
to cause the mating tabs 42 on the access member 18 to dislodge
from the recesses 32 on the head 24 of the pedicle screw 12. The
access member 18 may be formed in a molding process in the form of
a sleeve having a longitudinally extending cannula 44, and may
thereafter be joined to the head 24 of the pedicle screw 12 by
mechanically interlocking the sleeve 18 onto the head 24 of the
pedicle screw 12 with the mating tabs 42 and receiving channels or
recesses 32.
With continued reference to FIGS. 1-2, the sleeve 18 includes an
aperture 48 proximate the second end 38 for receiving various
components including a fastener 50, such as a set screw, for
securing the flexible member 22 to the head 24 of the pedicle screw
12, as will be described more fully below. The aperture 48 leads to
the cannula 44 of the access member 18 to provide percutaneous
access to the head 24 of the pedicle screw 12.
Longitudinally extending and laterally oriented threads 52 are
formed on the inwardly facing surfaces of the arms 30 in the
channel 28 of the head 24. The threads 52 are sized for engagement
with the fastener 50 when it is desired to secure the flexible
member 22 to the head 24 of the pedicle screw 12. In one
embodiment, a driver 54 (FIG. 7) or other tool suitable for
engaging a socket 56 in a top face of the fastener, or set screw,
50 may be inserted through the cannula 44.
While the fastener 50 has been shown and described herein as
comprising a set screw, it will be recognized that various other
types of securing members may alternatively be used to secure the
flexible member 22 to the head 24 of the anchor 12. Likewise, the
sleeve 18 may be configured to accommodate these various other
types of fasteners and to percutaneously provide access for them to
the anchor 12.
Referring now to FIG. 3, use of a tool 60 to install components of
the spinal stabilization system 10 to the vertebrae 14,16 of a
spine will now be described. Vertebral anchor 12 and sleeve 18
mated together have been inserted through a minimally invasive
incision formed in a patient's skin to be threadably secured into
the pedicle areas of a vertebra 14,16. The tool 60 in one
embodiment as shown includes a tubular member 62 extending
longitudinally and defines a central cannula 64 extending from a
distal end 66 of the tool 60. The tool 60 includes a handle 68 at
the proximal end 70 of the tubular member 62, and the handle 68 and
tubular member 62 in combination form a generally T-shaped
configuration according to one embodiment of the tool 60. In one
embodiment, the T-shaped handle configuration of handle 68 can be
incorporated into the sleeve 18. The proximal end 70 of the cannula
64 in the tubular member 62 is accessed through a port 72 in the
handle 68 as shown in FIGS. 3 and 4. The port 72 is sized to
receive a fastener 50. The handle 68 provides a convenient grip for
a surgeon to grasp the tool 60 for manipulation during installation
of the spinal stabilization system 10. The distal end 66 of the
tubular member 62 includes a pair of diametrically opposed fingers
74 projecting downwardly. Tool receiving channels, such as recesses
76, are formed on an inner face of each finger 74 and extend
longitudinally toward the body portion of the tubular member 62.
The cannula 64 and tubular member 62 are sized and configured to
fit over the access member 18 and pedicle screw 12 combination as
shown in FIG. 3.
Referring to FIG. 4, with the tool 60 installed onto and over the
access member 18 and pedicle screw 12 in a generally telescopic
arrangement, the recesses 76 at the distal end 66 of the tubular
member 62 mate with outwardly directed tool mating tabs 78 on the
distal end of the access member 18. As a result, the tool 60 is
mated with the vertebral anchor 12 and access member 18. The mating
interaction of the mating tabs 42, 78 and recesses 32, 76 allow the
T-shaped tool 60 to drive the pedicle screw 12 as well as act as an
anti-torque instrument. The surgeon rotates the tool 60 mated with
the vertebral anchor 12 and access member 18 to screw the vertebral
anchor 12 into the vertebra 14,16. The tool 60 can then be
uncoupled from the access member 18 by dislodging the tool mating
tabs 78 from the recess 76, thereby leaving the access member 18
mounted on the pedicle screw 12 installed on the vertebra
14,16.
The above-described description of the installation of the pedicle
screw 12 may be performed on each of the pedicle screws 12 utilized
in the stabilization system 10 as appropriate. In FIG. 5, the
attachment of the connecting member, such as the exemplary flexible
member 22 in the form of a flexible cord, to one of the pedicle
screws 12 is shown. The pedicle screw 12 installed in the vertebra
14 has the access member 18 mounted thereto as shown in FIG. 5. A
terminal end 22a of the connecting element 22 is inserted through
the slots 34 of the access member 18 and this is likely performed
at a portion of the slots 34 and access member 18 extending from
the patient's body and above the incision. A forceps 80 having a
pair of elongate handle members 82 pivotally coupled together can
be utilized to stabilize and maneuver the flexible member 22 in the
access member slots 34. The forceps 80 include cooperating jaws 84,
each of which has an arcuate portion 86 and a downwardly depending
leg 88 with a notch 90 proximate the distal end of the leg 88 as
shown in FIG. 5. In combination, the jaws 84 of the forceps 80
surround the access member 18 and the notches 90 clamp the end 22a
of the flexible member 22 projecting through the slot 34. Any
excess portion of the flexible member 22 that overhangs the notches
90 may be severed or trimmed as desired.
With the flexible member 22 clamped by the forceps 80 and
projecting through the slots 34 in the access member 18 as shown in
FIG. 5, the flexible member 22 may be passed through the slots 34
and down to the channel 28 of the pedicle screw 12. The forceps 80
clamped onto the flexible member 22 and around the access member 18
may be utilized to push the flexible member 22 from the slots 34
and into the channel 28. Alternatively, the tubular member 62 of
the tool 60 may be used in combination with the forceps 80 to
advance the flexible member 22 from the slots 34 downwardly and
into the upwardly open channel 28 of the pedicle screw 12 as shown
in FIG. 5.
With the flexible member 22 seated in the channel 28 and secured
therein by the forceps 80, the fastener or set screw 50 may be
percutaneously introduced through the cannula 44 of the access
member 18 for securing the flexible member 22 to the pedicle screw
12. A driver 54 or similar tool may be utilized to threadably
secure the set screw 50 to the head 24 of the pedicle screw 12
thereby securing the flexible member 22 to the pedicle screw 12.
The tubular member 62 and T-shaped tool 60 may continue to be
mounted telescopically on the access member 18 and pedicle screw 12
or removed for easier access and installation of the set screw
50.
Referring to FIGS. 6 and 7, the adjacent pedicle screw 12a has been
placed in the associated vertebra 14 with the procedure as
previously described. The spacer 20 is then put over the flexible
member 22 and slid into contact with the head 24 of the first
pedicle screw 12a as shown in FIG. 6. The tool 62 can be used to
create distraction between the vertebral anchors 12a, 12b to allow
for easier placement of the spacer 20 between the vertebral anchors
12a, 12b. Alternatively, a distractive force can be generated by
the placement of the spacer 20 between the vertebral anchors 12a,
12b. As the tool 62 shown in FIG. 6 is forced into engagement with
the spacer 20, the spacer 20 then generates a force against the
vertebral anchors 12a, 12b thus creating distraction of the
vertebrae.
The flexible member 22 is then inserted through the slots 34 of the
access member 18 on the second pedicle screw 12b and a connecting
element guide tool 92 can be slid over the access member 18 on the
second pedicle screw 12b as shown in FIGS. 6 and 7. The cord guide
tool 92 is similar to the T-shaped tool 60 previously described in
FIGS. 3 and 4 with like reference numerals identifying similar
features. The flexible member guide tool 92 also includes at least
one arcuate flange 94 projecting generally perpendicularly from the
axis of the tubular member 62. The arcuate flange 94 is sized and
configured to cradle a portion of the spacer 20 as the tool 92 is
pushed downwardly over the access member 18. The arcuate flange 94
contacts the end of the spacer 20 adjacent the second pedicle screw
12b and downward pressure on the tool 92 forces the spacer 20
downwardly and into position between the adjacent pedicle screw
heads 24. As the cord guide tool 92 slides downwardly over the
access member 18, the arcuate flange 94 translates the spacer 20
downward and outward to create distraction by reacting to the force
of the flexible member guide tool 92 and pushing against the access
member 18 on the second pedicle screw 12b and the head 24 of the
first pedicle screw 12a. Simultaneously, the flexible member 22
advances from the slots 34 of the access member 18 on the second
pedicle screw 12b and into the channel 28 of the head 24 of the
second pedicle screw 12b.
Advantageously, this invention utilizes the tools and spacer to
create distraction between the pedicle screw heads 24 and avoids
threading the flexible member 22 through an eyelet in the head of
the pedicle screw and any over distraction caused by the thickness
of the flexible member when pulled into position.
Once the spacer 20 is positioned between the pedicle screw heads 24
and the flexible member 22 is seated in the channel 28 of the
second pedicle screw 12b, the flexible member 22 may be tensioned
utilizing a tensioning tool 96 as shown in FIG. 7. After the
flexible member 22 is appropriately tensioned, the set screw 50 may
be passed through the port 70 in the handle 68 of the cord guide
tool 92 and seated in the channel 28 of the pedicle screw head 24.
The driver 54 is then utilized through the cannula 64 of the tool
92 and the access member 18 to mate with the set screw 50 and
rotate the set screw 50 into secure engagement in the channel 28
and thereby clamp the tensioned flexible member 22. The driver 54,
cord guide tool 92, access member 18 and tensioning tool 96 may
then be removed from the patient and the flexible member 22 trimmed
to length. Alternatively, if a multi-level spinal dynamic
stabilization system 10 is to be installed, the process is repeated
on subsequent vertebrae as appropriate and the incision closed to
complete the installation.
While this invention has been illustrated by the description of one
or more embodiments thereof, and while the embodiments have been
described in considerable detail, they are not intended to restrict
or in any way limit the scope of the appended claims to such
detail. Additional advantages and modifications will readily appear
to those skilled in the art. The invention in its broader aspects
is therefore not limited to the specific details, representative
apparatus and method and illustrative examples shown and described.
Accordingly, departures may be made from such details without
departing from the scope or spirit of the general inventive
concept.
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