U.S. patent application number 15/618566 was filed with the patent office on 2017-09-28 for intervertebral spacer device having recessed notch pairs for manipulation using a surgical tool.
The applicant listed for this patent is SpineCore, Inc.. Invention is credited to Michael W. Dudasik, Joseph P. Errico, Rafail Zubok.
Application Number | 20170273805 15/618566 |
Document ID | / |
Family ID | 46332119 |
Filed Date | 2017-09-28 |
United States Patent
Application |
20170273805 |
Kind Code |
A1 |
Errico; Joseph P. ; et
al. |
September 28, 2017 |
INTERVERTEBRAL SPACER DEVICE HAVING RECESSED NOTCH PAIRS FOR
MANIPULATION USING A SURGICAL TOOL
Abstract
Instrumentation for implanting an artificial intervertebral disc
includes static trials and a dynamic trial for determining the
appropriate size of disc to be implanted, static trial holders for
manipulating the static trials, inserter/impactors for inserting
and removing the static trials and for inserting the artificial
intervertebral discs, repositioners/extractors for repositioning
and extracting the static trials or the artificial intervertebral
discs, and a leveler for setting the proper position of the
artificial intervertebral disc. Methods for using the same are also
disclosed. Features for artificial intervertebral discs and
intervertebral spacer devices useful for manipulation by the
instrumentation are also disclosed.
Inventors: |
Errico; Joseph P.; (Warren,
NJ) ; Dudasik; Michael W.; (Nutley, NJ) ;
Zubok; Rafail; (Midland Park, NJ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
SpineCore, Inc. |
Allendale |
NJ |
US |
|
|
Family ID: |
46332119 |
Appl. No.: |
15/618566 |
Filed: |
June 9, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15014803 |
Feb 3, 2016 |
9700429 |
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15618566 |
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14340091 |
Jul 24, 2014 |
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15014803 |
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12321562 |
Jan 22, 2009 |
8940047 |
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14340091 |
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11716360 |
Mar 9, 2007 |
8303659 |
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12321562 |
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10663492 |
Sep 16, 2003 |
7223291 |
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11716360 |
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10425267 |
Apr 29, 2003 |
7235081 |
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10663492 |
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10282356 |
Oct 29, 2002 |
7169182 |
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10425267 |
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10256160 |
Sep 26, 2002 |
6989032 |
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10282356 |
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10175417 |
Jun 19, 2002 |
7563285 |
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10256160 |
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10151280 |
May 20, 2002 |
7604664 |
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10175417 |
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10140153 |
May 7, 2002 |
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10151280 |
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Apr 23, 2002 |
6863689 |
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10140153 |
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09982148 |
Oct 18, 2001 |
6673113 |
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10128619 |
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09906119 |
Jul 16, 2001 |
6607559 |
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09982148 |
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09970479 |
Oct 4, 2001 |
6669730 |
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10140153 |
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09968046 |
Oct 1, 2001 |
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09970479 |
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09970479 |
Oct 4, 2001 |
6669730 |
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10151280 |
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10309585 |
Dec 4, 2002 |
7115132 |
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10663492 |
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10282356 |
Oct 29, 2002 |
7169182 |
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10309585 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/4684 20130101;
A61F 2230/0065 20130101; A61B 2017/0256 20130101; A61F 2002/30565
20130101; A61F 2310/00365 20130101; A61F 2002/30365 20130101; A61F
2002/443 20130101; A61F 2002/30594 20130101; A61F 2220/0058
20130101; A61F 2002/30769 20130101; A61F 2002/30563 20130101; A61F
2002/30774 20130101; A61F 2002/302 20130101; A61F 2220/0033
20130101; A61F 2/30767 20130101; A61F 2220/0041 20130101; A61F
2002/3092 20130101; A61F 2/4611 20130101; A61B 17/025 20130101;
A61F 2002/4627 20130101; A61F 2/446 20130101; A61F 2220/0025
20130101; A61F 2002/30571 20130101; A61F 2310/00017 20130101; A61F
2002/30187 20130101; A61F 2002/30528 20130101; A61F 2002/30538
20130101; A61F 2002/30975 20130101; A61F 2002/30433 20130101; A61F
2002/4628 20130101; A61F 2/30742 20130101; A61F 2002/305 20130101;
A61F 2002/30841 20130101; A61F 2002/4619 20130101; A61F 2250/0006
20130101; A61F 2310/00023 20130101; A61F 2230/005 20130101; A61F
2230/0034 20130101; A61F 2002/30772 20130101; A61F 2002/30331
20130101; A61F 2002/30507 20130101; A61F 2002/30378 20130101; A61F
2002/30604 20130101; A61F 2002/30785 20130101; A61F 2002/30451
20130101; A61F 2002/30649 20130101; A61F 2002/30171 20130101; A61F
2/4425 20130101; A61F 2002/30518 20130101; A61F 2002/30909
20130101; A61F 2/442 20130101; A61F 2002/30492 20130101 |
International
Class: |
A61F 2/44 20060101
A61F002/44; A61B 17/02 20060101 A61B017/02; A61F 2/46 20060101
A61F002/46 |
Claims
1. A spinal implant system comprising: a spinal implant including
first and second baseplates capable of articulating relative to
each other, wherein the first and second baseplates each has a
first surface adapted to contact bone, an opposing second surface,
and an angled perimeter surface arranged between the first and
second surfaces, the angled perimeter surface defining a plurality
of flat surfaces angled relative to each other, wherein a first
recess is associated with a first of the plurality of flat surfaces
of at least the first baseplate, and a second recess is associated
with a second of the plurality of flat surfaces of at least the
first baseplate; and an instrument including a handle and a distal
portion adapted to engage the spinal implant, the distal portion
having at least one extension member projecting outwardly
therefrom, the extension member being engageable with the recesses,
wherein engaging the extension member with the first recess orients
the spinal implant at a first angled orientation relative to a
longitudinal axis of the insertion instrument, whereas engaging the
extension member with the second recess orients the spinal implant
at a second angled orientation relative to the longitudinal axis,
the first and second angled orientations corresponding to different
surgical approaches for the spinal implant during use.
2. A system according to claim 1, wherein the second surface of the
second baseplate includes a spherical articulating member, and the
second surface of the first baseplate includes a pocket adapted to
receive the spherical articulating member to allow articulation of
the first and second baseplates relative to each other.
3. A system according to claim 1, wherein the angled perimeter
surface of each of the first and second baseplates includes at
least three flat surfaces angled relative to each other, a first of
the flat surfaces converging with a second of the flat surfaces to
form a first protruding corner, the first of the flat surfaces also
converging with a third of the flat surfaces to form a second
protruding corner.
4. A system according to claim 3, wherein the instrument is an
insertion instrument that includes a flat surface at its distal
portion for confronting at least one of the first through third
flat surfaces of the implant, and opposing projections extending
past the flat surface of the insertion instrument.
5. A system according to claim 4, wherein when the flat surface of
the insertion instrument confronts at least one of the first
through third flat surfaces of the implant, the projections of the
insertion instrument confront other surfaces of the implant to
prevent relative rotation between the instrument and the implant
during use.
6. A system according to claim 1, wherein a third recess is
associated with a third of the plurality of flat surfaces of at
least the first baseplate, and engaging the extension member of the
instrument with the third recess orients the implant at a third
angled orientation relative to the longitudinal axis of the
instrument.
7. A system according to claim 6, wherein the first angled
orientation corresponds to an anterior midline approach for
implantation, repositioning, or extraction of the implant, and the
second and third angled orientations correspond to opposing
antero-lateral approaches for implantation, repositioning, or
extraction of the implant.
8. A system according to claim 1, wherein the instrument includes a
plurality of extension members projecting from its distal portion,
and a third recess is associated with a third of the plurality of
flat surfaces of at least the first baseplate, the plurality of
extension members being simultaneously engageable with at least the
first and second or second and third recesses.
9. A system according to claim 8, wherein engaging the plurality of
extension members with the first and second recesses orients the
implant into the first angled orientation and engaging the
plurality of extension members with the second and third recesses
orients the implant into the second angled orientation.
10. A system according to claim 9, wherein the first and second
angled orientations correspond to opposing antero-lateral
approaches for use of the instrument.
11. A spinal implant system comprising: a spinal implant including
first and second baseplates each having a first surface adapted to
contact bone, an opposing second surface, and a perimeter surface
arranged between the first and second surfaces, wherein first and
second recesses are associated with the perimeter surface of at
least the first baseplate; and an instrument including a handle and
a distal portion adapted to engage the spinal implant, the distal
portion having at least one extension member projecting therefrom,
the extension member being engageable with the recesses, wherein
engaging the extension member with the first recess orients the
spinal implant at a first angled orientation relative to a
longitudinal axis of the insertion instrument, whereas engaging the
extension member with the second recess orients the spinal implant
at a second angled orientation relative to the longitudinal axis,
the first and second angled orientations corresponding to different
surgical approaches for the spinal implant during use.
12. A system according to claim 1, wherein the second surface of
the second baseplate includes a spherical articulating member, and
the second surface of the first baseplate includes a pocket adapted
to receive the spherical articulating member to allow articulation
of the first and second baseplates relative to each other.
13. A system according to claim 1, wherein the perimeter surface is
defined by a plurality of flat surfaces angled relative to each
other, and wherein the first and second recesses are associated
with at least a first and second of the plurality of flat
surfaces.
14. A system according to claim 1, wherein a plurality of recesses
are associated with the perimeter surface of each of the first and
second baseplates, and the extension member of the instrument is
engageable with the recesses.
15. A system according to claim 4, wherein engaging the extension
member with different recesses orients the implant at different
angled orientations relative to the longitudinal axis of the
instrument.
16. A system according to claim 5, wherein each different angled
orientation for the implant corresponds to a particular
implantation, repositioning, or extraction approach for the spinal
implant during use.
17. A system according to claim 1, wherein the perimeter surface of
each of the first and second baseplates includes at least three
flat surfaces angled relative to each other, a first of the flat
surfaces converging with a second of the flat surfaces to form a
first protruding corner, the first of the flat surfaces also
converging with a third of the flat surfaces to form a second
protruding corner.
18. A system according to claim 7, wherein the instrument is an
insertion instrument that includes a flat surface at its distal
portion for confronting at least one of the first through third
flat surfaces of the implant, and opposing projections extending
past the flat surface of the insertion instrument.
19. A system according to claim 8, wherein when the flat surface of
the insertion instrument confronts at least one of the first
through third flat surfaces of the implant, the projections of the
insertion instrument confront other surfaces of the implant to
prevent relative rotation between the instrument and the implant
during use.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a divisional of U.S. application
Ser. No. 15/014,803, filed Feb. 3, 2016, which is a continuation of
U.S. patent application Ser. No. 14/340,091, filed Jul. 24, 2014,
which is a continuation of U.S. patent application Ser. No.
12/321,562, filed Jan. 22, 2009, now U.S. Pat. No. 8,940,047 ("the
'047 patent") which is a continutation of U.S. patent application
Ser. No. 11/716,360, filed Mar. 9, 2007, now U.S. Pat. No.
8,303,659 ("the '659 patent") which is a continuation application
of U.S. patent application Ser. No. 10/663,492, filed Sep. 16,
2003, now U.S. Pat. No. 7,223,291 ("the '291 patent"), which is a
continuation-in-part of U.S. patent application Ser. No.
10/282,356, filed Oct. 29, 2002, now U.S. Pat. No. 7,169,182 ("the
'182 patent") and a continuation-in-part of U.S. patent application
Ser. No. 10/309,585, filed Dec. 4, 2002, now U.S. Pat. No.
7,115,132 ("the '132 patent") and a continuation-in-part of U.S.
patent application Ser. No. 10/425,267, filed Apr. 29, 2003, now
U.S. Pat. No. 7,235,081 ("the '081 patent"), which is a
continuation-in-part of the '182 patent. The '182 patent is a
continuation-in-part of U.S. patent application Ser. No.
10/256,160, filed Sep. 26, 2002, now U.S. Pat. No. 6,989,032 ("the
'032 patent"), which is a continuation-in-part of U.S. patent
application Ser. No. 10/175,417, filed Jun. 19, 2002, now U.S. Pat.
No. 7,563,285 ("the '285 patent"), which is a continuation-in-part
of U.S. patent application Ser. No. 10/151,280, filed May 20, 2002,
now U.S. Pat. No. 7,604,664 ("the '664 patent"), which is a
continuation-in-part of U.S. patent application Ser. No.
09/970,479, filed Oct. 4, 2001, now U.S. Pat. No. 6,669,730 ("the
'730 patent"), and a continuation-in-part of U.S. patent
application Ser. No. 10/140,153, filed May 7, 2002, ("the '153
application"), now abandoned. The '132 patent (detailed above) is a
continuation-in-part of the '182 patent, and the '730 patent is a
continuation-in-part of U.S. patent application Ser. No.
09/968,046, filed Oct. 1, 2001, ("the '046 application"), now
abandoned, and the '153 application is a continuation-in-part of
the '730 patent (detailed above) as well as U.S. patent application
Ser. No. 10/128,619, filed Apr. 23, 2002, now U.S. Pat. No.
6,863,689 ("the '689 patent"), which is a continuation-in-part of
both U.S. patent application Ser. No. 09/906,119, filed Jul. 16,
2001, now U.S. Pat. No. 6,607,559 ("the '559 patent"), as well as
U.S. patent application Ser. No. 09/982,148, filed Oct. 18, 2001,
now U.S. Pat. No. 6,673,113 ("the '113 patent"). All of the above
mentioned applications are hereby incorporated by reference herein
in their respective entireties.
FIELD OF THE INVENTION
[0002] This invention relates generally to systems and methods for
use in spine arthroplasty, and more specifically to instruments for
distracting an intervertebral space, inserting and removing trial
artificial intervertebral discs, and inserting, impacting,
repositioning, leveling and extracting artificial intervertebral
discs, and methods of use thereof, and also more specifically to
intervertebral spacer devices and artificial intervertebral discs
having features rendering them suitable for manipulation
thereby.
BACKGROUND OF THE INVENTION
[0003] The bones and connective tissue of an adult human spinal
column consists of more than twenty discrete bones coupled
sequentially to one another by a tri-joint complex that consists of
an anterior disc and the two posterior facet joints, the anterior
discs of adjacent bones being cushioned by cartilage spacers
referred to as intervertebral discs. These more than twenty bones
are anatomically categorized as being members of one of four
classifications: cervical, thoracic, lumbar, or sacral. The
cervical portion of the spine, which comprises the top of the
spine, up to the base of the skull, includes the first seven
vertebrae. The intermediate twelve bones are the thoracic
vertebrae, and connect to the lower spine comprising the five
lumbar vertebrae. The base of the spine is the sacral bones
(including the coccyx). The component bones of the cervical spine
are generally smaller than those of the thoracic spine, which are
in turn smaller than those of the lumbar region. The sacral region
connects laterally to the pelvis. While the sacral region is an
integral part of the spine, for the purposes of fusion surgeries
and for this disclosure, the word spine shall refer only to the
cervical, thoracic, and lumbar regions.
[0004] The spinal column is highly complex in that it includes
these more than twenty bones coupled to one another, housing and
protecting critical elements of the nervous system having
innumerable peripheral nerves and circulatory bodies in close
proximity. In spite of these complications, the spine is a highly
flexible structure, capable of a high degree of curvature and twist
in nearly every direction.
[0005] Genetic or developmental irregularities, trauma, chronic
stress, tumors, and degenerative wear are a few of the causes that
can result in spinal pathologies for which surgical intervention
may be necessary. With respect to the failure of the intervertebral
disc, and the insertion of implants and/or height restorative
devices, several methods and devices have been disclosed in the
prior art that achieve immobilization and/or fusion of adjacent
bones by implanting artificial assemblies in or on the spinal
column. More recently, the development of non-fusion implant
devices, which purport to permit continued natural movement in the
tri-joint complex, have provided great promise as a preferably
alternative to fusion devices. The region of the back that needs to
be corrected, as well as the individual variations in anatomy,
determine the appropriate surgical protocol and implantation
assembly. Generally, the preparation of the intervertebral space
for the receipt of fusion or non-fusion devices involves removing
the damaged disc material and thereafter distracting the adjacent
vertebral bones to their appropriate distance apart. Once the
proper height of the intervertebral space is restored, the fusion
or non-fusion device can be implanted.
[0006] It is an object of the invention to provide artificial
intervertebral disc and intervertebral spacer device features, as
well as instrumentation and methods, that enable surgeons to more
accurately, easily, and efficiently prepare the intervertebral
space and implant fusion or non-fusion devices. Other objects of
the invention not explicitly stated will be set forth and will be
more clearly understood in conjunction with the descriptions of the
preferred embodiments disclosed hereafter.
BRIEF SUMMARY OF THE INVENTION
[0007] The preceding objects are achieved by the invention, which
includes artificial intervertebral disc and intervertebral spacer
device features suitable for manipulation thereof by surgical
instrumentation, and further includes static trial artificial
intervertebral discs (sometimes referred to herein as a "static
trial"), static trial artificial intervertebral disc holders
(sometimes referred to herein as "static trial holders"), a dynamic
trial artificial intervertebral disc (sometimes referred to herein
as a "dynamic trial"), artificial intervertebral disc
inserter/impactors (sometimes referred to herein as
"inserter/impactors"), an artificial intervertebral disc
repositioner/extractor (sometimes referred to herein as a
"repositioner/extractor"), and an artificial intervertebral disc
leveler (sometimes referred to herein as a "leveler").
[0008] More particularly, the features, systems, and methods
disclosed herein are intended for use in spine arthroplasty
procedures, and specifically for use with the features, systems,
and methods described herein in conjunction with the features,
systems, and methods described in the '182, '132, '081 and '032
patents and U.S. Pat. No. 7,160,327 ("the '327 patent"), as well as
those described in U.S. patent application Ser. No. 09/906,127
(filed Jul. 16, 2001) entitled "Insertion Tool For Use With
Intervertebral Spacers" ("the '127 application"), now abandoned,
which is hereby incorporated by reference herein. However, it
should be understood that the features, systems, and methods
described herein are also suitable for use with other features,
systems, and methods without departing from the scope of the
invention.
[0009] For example, while the static trials described herein are
primarily intended for use in determining the appropriate size of
particular embodiments of the artificial intervertebral disc
implants described in the '032 and '327 patents to be implanted (or
whether a particular size can be implanted) into the distracted
intervertebral space, they can also be used for determining the
appropriate size of any other suitably configured orthopedic
implant or trial to be implanted (or whether a particular size can
be implanted) into the distracted intervertebral space. They can
also be used to distract an intervertebral space (e.g., in the same
manner in which the trial spacers in the '127 application are used
as described in the '127 application).
[0010] And, for example, while the static trial holders described
herein are primarily intended for use in holding, inserting,
removing, and otherwise manipulating the static trials described
herein, they can also be used for manipulating any embodiment of
the trial spacers described in the '127 application (also referred
to therein and herein as distraction spacers), and can also be used
for manipulating any other suitably configured orthopedic
device.
[0011] And, for example, while the dynamic trial described herein
is primarily intended for use in distracting an intervertebral
space according to the procedures described herein and/or for
determining the appropriate size of particular embodiments
artificial intervertebral disc implants described in the '032 and
'327 patents to be implanted (or whether a particular size can be
implanted) into the distracted intervertebral space, it can also be
used for distracting an intervertebral space according to other
procedures and/or for determining the appropriate size of any other
suitably configured orthopedic implant or trial to be implanted (or
whether a particular size can be implanted) into the distracted
intervertebral space.
[0012] And, for example, while the inserter/impactors described
herein are primarily intended for use in holding, inserting,
removing, impacting, extracting, and otherwise manipulating
particular embodiments of the artificial intervertebral disc
implants described in the '032 and '327 patents, they can also be
used for manipulating any other suitably configured orthopedic
implant or trial.
[0013] And, for example, while the repositioners/extractors
described herein are primarily intended for use in repositioning
and/or extracting and/or otherwise manipulating particular
embodiments of the artificial intervertebral disc implants
described in the '032 and '327 patents, they can also be used for
manipulating any other suitably configured orthopedic implant or
trial.
[0014] And, for example, while the leveler described herein is
primarily intended for use in setting the proper position of,
and/or otherwise manipulating, particular embodiments of the
artificial intervertebral disc implants described in the '032 and
'327 patents, it can also be used for manipulating any other
suitably configured orthopedic implant or trial.
[0015] While the instrumentation described herein (e.g., the static
trials, static trial holders, dynamic trial, inserter/impactors,
repositioners/extractors, and leveler) will be discussed for use
with the artificial intervertebral disc of FIGS. 13-20, such
discussions are merely by way of example and not intended to be
limiting of their uses. Thus, it should be understood that the
tools can be used with any of the artificial intervertebral discs
disclosed in the '032 and '327 patents, or any other artificial
intervertebral disc having (or being modifiable or modified to
have) suitable features therefor. Moreover, it is anticipated that
the features of the artificial intervertebral disc (e.g., the
angled flat surfaces and accompanying holes and inwardly facing
baseplate surfaces) and/or the static trials (e.g., the cylindrical
trunks and angled flat surfaces and opposing notches and
accompanying holes) that are used by the tools discussed herein to
hold and/or manipulate these devices (such features, it should be
noted, were first shown and disclosed in the '182, '132, '081, '032
and '327 patents) can be applied, individually or collectively or
in various combinations, to other trials, spacers, artificial
intervertebral discs or other orthopedic devices as stand-alone
innovative features for enabling such trials, spacers, artificial
intervertebral discs, or other orthopedic devices to be more
efficiently and more effectively held and/or manipulated by the
tools described herein or by other tools having suitable features.
In addition, it should be understood that the invention encompasses
artificial intervertebral discs, spacers, trials (static or
dynamic), and/or other orthopedic devices, that have one or more of
the features disclosed herein, in any combination, and that the
invention is therefore not limited to artificial intervertebral
discs, spacers, trials, and/or other orthopedic devices having all
of the features simultaneously.
[0016] More particularly with regard to the static trials described
herein, a plurality of static trials are provided primarily for use
in determining the appropriate size of an artificial intervertebral
disc to be implanted (or whether a particular size of the
artificial intervertebral disc can be implanted) into the
distracted intervertebral space (e.g., the artificial
intervertebral disc 160 of FIGS. 13-20). Preferably, for each
artificial intervertebral disc to be implanted, a plurality of
sizes of the artificial intervertebral disc would be available.
That is, preferably, a plurality of the same type of artificial
intervertebral disc would be available, each of the plurality
having a respective width and depth dimension combination that
allows it to fit within a correspondingly dimensioned
intervertebral space. For example, the plurality of artificial
intervertebral discs could include artificial intervertebral discs
having widths being either 35 mm or 40 mm, and depths ranging from
14 mm to 18 mm in 1 mm increments, for a total of 10 discs.
Accordingly, preferably, each of the plurality of static trials for
use with a particular plurality of differently sized artificial
intervertebral discs would have a respective width and depth
dimension set corresponding to the width and depth of a respective
one of the plurality of differently sized artificial intervertebral
discs. For example, the plurality of static trials for use with the
set of artificial intervertebral discs described for example could
include static trials having widths being either 35 mm or 40 mm,
and depths ranging from 14 mm to 18 mm in 1 mm increments, for a
total of 10 static trials. It should be understood that the
artificial intervertebral discs and/or the static trials can be
offered in a variety of dimensions without departing from the scope
of the invention, and that the dimensions specifically identified
and quantified herein are merely exemplary. Moreover, it should be
understood that the set of static trials need not include the same
number of trials for each artificial intervertebral disc in the set
of artificial intervertebral discs, but rather, none, one, or more
than one trial can be included in the trial set for any particular
artificial intervertebral disc in the set.
[0017] Each of the plurality of static trials preferably further
includes features that can be used by the static trial holders
(described below), the inserter/impactors (described below), and
the repositioners/extractors (described below). With regard to a
feature that can be used by the static trial holder, each static
trial preferably includes a recess that can be engaged by the
opposing semicircular extents of the static trial holder.
Preferably, this recess forms a perimetrical groove (a groove that
extends around at least a portion of the perimeter of the static
trial, e.g., an annular groove) that establishes a trunk (e.g., a
cylindrical trunk) between the baseplates of the static trial, such
that the baseplates extend as flanges from either end of the trunk.
Accordingly, preferably, the opposing semicircular extents each
have a thickness smaller than the width of the annular groove, and
as such fit into the annular groove to grip the cylindrical trunk
between them.
[0018] Additional features that can be used by the static trial
holders include (on any static trial surface that faces the desired
engagement approach direction of the static trial holder, e.g., on
each of the anteriorly facing and anterior-laterally facing flat
surfaces of the static trial as described below) opposing recesses,
preferably formed as upper and lower notches, an upper notch in the
upper baseplates and a lower notch in the lower baseplate.
Preferably, the notches are sized so that the opposing notches of
each pair form a volume that is dimensioned to closely accommodate
the dimensions of the static trial holder's prongs' cross-section.
That is, as described below, the body of each prong is thicker than
the semicircular extent that extends from the body, and as such,
whereas the semicircular extents fit into the annular groove, the
prongs do not because their thickness is greater than the width of
the annular groove opening. Each notch pair accommodates this
greater thickness, and as such, as the opposing semicircular
extents of the static trial holder are placed into the annular
groove, the bodies of the prongs of the static trial holder pass
into the notches so that the semicircular extents can continue into
the annular groove and be seated around the cylindrical trunk. Once
the prongs are fitted within the notch pair, interference between
the prongs and the notch walls limits or prevents rotation of the
static trial about a longitudinal axis (e.g., an axis parallel to
the longitudinal axis of the cylindrical trunk) with respect to the
static trial holder.
[0019] With regard to features that can be used by the
inserter/impactors, each static trial (and each artificial
intervertebral disc that the trials approximate) preferably
includes an anteriorly facing flat surface, flanked by two
anteriolaterally facing flat surfaces (one on each side of the
anteriorly facing flat surface), and, to provide for holding of the
static trial or disc for an anterior insertion approach, a hole
spaced from the anteriorly facing flat surface, the hole having a
longitudinal axis parallel to the anteriorly facing flat surface.
The holding pin of the inserter/impactor fits within the hole, and
the angled flat surfaces of the static trial or disc fit against
the correspondingly angled flat surfaces of the inserter/impactor,
and operation of the inserter/impactor pulls the holding pin toward
the flat surface of the inserter/impactor opposite the pin, to
rigidly hold the static trial or disc by the baseplate.
[0020] In some embodiments of the inserter/impactor having a wedge
plate, the holding pin protrudes from a wedge-shaped extended
surface of the distal end of the inserter/impactor and is
restricted from upward movement with respect to the distal head by
the presence of the wedge-shaped extended surface of the distal end
of the inserter/impactor. More particularly, with any attempted
upward movement of the holding pin, the pin encounters the upper
surface of the channel in which the pin travels, preventing any
such upward movement.) When the static trial or artificial disc is
held in this manner, rotation of the static trial or disc about a
longitudinal axis (e.g., in the case of the trials, an axis
parallel to the longitudinal axis of the cylindrical trunk)
relative to the inserter/impactor is prevented by interference of
the corners of the static trial's or disc's flat surfaces and the
corners of the inserter/impactor's flat surfaces, similar to the
manner in which a wrench holding a nut prevents rotation of the nut
relative to the wrench. Further, the holding of the static trial or
disc in this manner allows for some repositioning of the static
trial or disc in the intervertebral space via rotation of the
static trial or disc in either direction about the longitudinal
axis of the intervertebral space.
[0021] Further, in some embodiments of the inserter/impactor having
a wedge plate, when the trial or disc is held in this manner,
rotation of the trial or disc about a lateral axis of the trial or
disc relative to the inserter/impactor is prevented by interference
of the inwardly facing surface of the first baseplate (e.g., upper
baseplate) of the trial or disc and the corresponding surface
(e.g., upper surface) of the wedge on the distal end, and by
interference of the inwardly facing surface of the second baseplate
(e.g., lower baseplate) of the trial or disc and the corresponding
surface (e.g., lower surface) of the wedge on the distal end. With
regard to artificial discs, it is preferable that the wedge on the
inserter/impactor will interfere between the first and second
baseplates (e.g., upper and lower) so that the surfaces of the
first and second baseplates align at a preferred 15 degrees angle
of lordosis when the disc is held by the inserter/impactor.
[0022] Preferably, both of the baseplates of the static trial or
disc have similarly configured flat surfaces, and both baseplates'
flat surfaces fit against the angled flat surfaces of the
inserter/impactor to provide for a more secure holding of the
static trial or disc by the inserter/impactor. Also preferably, in
order to provide for a holding of the static trial or disc for two
additional (here, anteriolateral) insertion approaches, each static
trial or disc also includes two additional holes, one spaced apart
from one of the anteriolaterally facing flat surfaces, and the
other spaced apart from the other of the anteriolaterally facing
flat surfaces. Accordingly, operation of the inserter/impactor can
fit the holding pin into either of these two additional holes, and
hold the anteriolaterally facing flat surface (the one associated
with the hole into which the pin is fit) of the static trial or
disc against the flat surface of the inserter/impactor opposite the
pin. It should be understood that preferably, in order to
facilitate these two additional approaches, the angle separating
the anteriorly facing flat surface of the static trial or disc and
one of the anteriolaterally facing flat surfaces of the static
trial or disc is equal to the angle separating the anteriorly
facing flat surface and the other of the anteriolaterally facing
flat surfaces.
[0023] With regard to features that can be used by the
repositioners/extractors, each static trial (and each artificial
intervertebral disc that the trials approximate) preferably
includes at least two holes extending longitudinally into one of
the baseplates of the trial or disc from the inwardly facing
surface of the baseplate. More than two holes can be used to
provide for multiple repositioning/extracting approaches.
Preferably, in order for the same repositioning/extracting tool to
be used for multiple approaches on the same trial or artificial
intervertebral disc, adjacent holes should be separated by the same
distance separating other adjacent holes.
[0024] As discussed in greater detail below with regard to the
repositioners/extractors, in order to engage two of the holes, each
repositioner/extractor has two pins extending in parallel from a
central shaft, perpendicular to the longitudinal axis of the
central shaft. The pins can be inserted into the holes, and pulling
or pushing on the central shaft along its longitudinal axis when
the holes are engaged pulls or pushes the static trial or
artificial intervertebral disc in the intervertebral space.
Further, because two holes are engaged, the static trial or
artificial intervertebral disc can be rotated in either direction
about a longitudinal axis passing through the intervertebral space,
by rotating of the central shaft of the repositioner/extractor
about its distal end, about an axis parallel to the longitudinal
axes of the pins.
[0025] On each repositioner/extractor, the pins are formed on
prongs that extend laterally from the central shaft. The direction
of the prongs, and the location of the pins relative to the central
shaft, determine the angle or angles of surgical approach for which
a particular repositioner/extractor can be used. Further, the
number and location of holes further determine the angle or angles
of surgical approach for which a particular repositioner/extractor
can be used. Accordingly, the present invention contemplates a
variety of repositioner/extractors, and a variety of holes
configurations, to provide the surgeon with a variety of possible
surgical approach angles.
[0026] As described in greater detail below, three
repositioner/extractors are illustrated and described (symmetric,
offset left, and offset right) for example, and, for example, two
hole configurations are illustrated and described. A first hole
configuration includes the hole configuration described above, that
is, three holes on one of the baseplates (e.g., the lower
baseplate), the holes being configured so that a first hole is
located in the anterior-posterior plane, and the adjacent (second
and third) holes are located in respective opposing anteriolateral
planes on either side of the first hole. A second hole
configuration includes four holes on one of the baseplates (e.g.,
the upper baseplate), the holes being configured so that first and
second holes straddle the anterior-posterior plane, a third hole is
located so that the third hole and the first hole straddle one of
the opposing anteriolateral planes, and a fourth hole is located so
that the fourth hole and the second hole straddle the other of the
opposing anteriolateral planes.
[0027] With regard to the static trial holders described herein,
the static trial holders are provided primarily for use in holding,
inserting, removing, and otherwise manipulating the static trials
described herein. Preferably, the static trial holder has (in some
embodiments, at an end of an extension of the static trial holder)
a pair of opposing prongs that open away from one another and close
toward one another. Each of the prongs has a semicircular extent
and the semicircular extents face one another to define a circular
holding enclosure that is useful for capturing the cylindrical
trunk of the static trial between them. The prongs are spring
biased toward a neutral position such that the holding enclosure is
spring biased to a receptive state in which the cylindrical trunk
can be snapped into (or out of) the holding enclosure by
temporarily placing the holding enclosure in an expanded state (by
forcing the cylindrical trunk against the mouth of the enclosure)
that allows passage of the cylindrical trunk through the mouth of
the enclosure.
[0028] Once the cylindrical trunk is in the enclosure, the holding
enclosure can be placed in a contracted state, or locked, where the
trial is more securely held, so that the trial will not escape the
holding enclosure as it is experiencing greater forces while being
inserted and removed from the intervertebral space. This locking is
effected by rotating a sleeve that surrounds the prongs. The bore
of the sleeve is configured to press the prongs together when the
sleeve is rotated a quarter turn (ninety degrees), and to allow
them to separate when the sleeve is again (or in some embodiments,
reverse) rotated a quarter turn (in either direction). (In some
embodiments, either quarter turn is in either direction; e.g., in
certain embodiments illustrated herein, the quarter turn that
separates the prongs is a reverse rotation of the quarter turn that
presses them together). In some embodiments, the sleeve is biased
toward stopping its rotation at either the "locked" or "unlocked"
states of the holding enclosure, by the cooperation of recesses on
the extension's outer surface and corresponding spring plungers
radially disposed to project from the sleeve's inner surface. In
other embodiments, the sleeve stops its rotation at either the
"locked" or "unlocked" states of the holding enclosure, due to
radially inwardly directed screw heads on the sleeve's inner
surface that ride in ninety-degree arc grooves on the extension's
outer surface and that stop when the end of the groove is
reached.
[0029] Further, the sleeve of the static trial holder preferably
has on its exterior surface at least one stop protrusion that is
positioned and dimensioned to extend dorsally or ventrally from the
exterior surface when the holding enclosure is in its "locked"
state, so that when the surgeon inserts the static trial into the
intervertebral space, the stop protrusions prevent the static trial
from being inserted too far into the space (that is, so that the
stop protrusions hit against the lips of the adjacent vertebral
body endplates before the static trial is inserted too far).
[0030] It should be understood that when a static trial is being
held (either when the holding enclosure is in its receptive state
or in its contracted state), because the semicylindrical extents
fit within the annular groove of the static trial, the static trial
will not escape from the enclosure along the longitudinal axis of
the cylindrical trunk. While the static trial holders are discussed
herein as primarily used for manipulating the static trials, they
are preferably is also useful for manipulating the distraction
spacers described in the '127 application, in that the semicircular
extents of the pincers preferably also interact with the annular
grooves and cylindrical trunks of those distraction spacers in the
same manner as described herein.
[0031] With regard to the dynamic trial described herein, the
dynamic trial is provided primarily for distracting an
intervertebral space according to the procedures described herein
and/or for determining the appropriate size of an artificial
intervertebral disc to be implanted (or whether a particular size
can be implanted) into the distracted intervertebral space. While
the distraction systems and methods described in the '127
application are also useful for distracting an intervertebral
space, the dynamic trial is provided as an additional or alternate
distraction tool. Further, while the static trials described herein
as useful for determining the appropriate size of an artificial
intervertebral disc to be implanted (or whether a particular size
can be implanted), the dynamic trial is provided as an additional
or alternate sizing tool.
[0032] The dynamic trial preferably includes a shaft having a
bifurcated trial at a distal end. Each half of the bifurcated trial
preferably has on its outwardly facing surface a convex dome that
is shaped like the convex dome of the corresponding baseplate of
the artificial intervertebral disc that the dynamic trial
approximates. The shaft includes an inner shaft portion that
centrally divides into upper and lower distal extensions that, from
the point of division to their distal ends, are each biased toward
positions in which they converge toward one another. The lower
distal extension is connected to the lower half of the bifurcated
trial, and the upper distal extension is connected to the upper
half of the bifurcated trial. Preferably, the upper half is
adjustably connected to the upper distal extension by a pivot pin
that allows the upper half to rotate about a lateral axis that
passes through the longitudinal and lateral center of the
bifurcated trial. This axis of rotation allows the upper half, when
separating from the lower half, to adjust to the orientation of the
upper vertebral bone without causing the bone to hinge relative to
the lower vertebral bone. In order to effect the separation of the
upper and lower halves, the shaft further includes an outer shaft
potion that is translatable adjacent the inner shaft portion, the
outer shaft portion having a pin that passes between the distal
extensions.
[0033] The outer shaft portion is preferably translatable distally
by the forward movement of a control knob near the proximal end of
the shaft, and translatable proximally by backward movement of the
control knob. As the outer shaft portion is pushed distally, the
pin is pushed distally to overcome the bias of the divided
extensions to separate them and correspondingly separate the halves
of the bifurcated trial. Preferably, markings are provided on the
inner shaft portion to quantify the depth (to which the bifurcated
trial has been expanded) corresponding to the distance that the
outer shaft portion has been translated with respect to the inner
shaft portion. It is anticipated that the pushing force required to
separate the halves will increase as they separate, due to the
compression of the spine seeking to close the intervertebral space
and the annulus seeking to prevent the adjacent vertebral discs
from separating beyond a certain point. Therefore, to provide a
mechanical advantage to the operator in the event that greater
distraction is required, but the operator cannot push the control
knob farther with unaided human effort, an fine control knob is
provided. The fine control knob is preferably threaded onto the
proximal end of the inner shaft portion, proximal to the control
knob. Thus, rotation of the fine control knob about the
longitudinal axis of the inner shaft portion will cause the body of
the fine control knob to press against the control knob to move it
farther distally. The interference of the threads of the fine
control knob-inner shaft portion interface prevents the fine
control knob from backing up proximally unless the fine control
knob is reverse rotated to effect that result. Finally, the
proximal end of the shaft is preferably flanged to serve as a slap
hammer for impaction, if necessary for proper positioning of the
bifurcated trial, and/or forced extraction of the bifurcated
trial.
[0034] With further regard to the inserter/impactors described
herein, the inserter/impactors are provided primarily for holding,
inserting, repositioning, removing, impacting, extracting, and
otherwise manipulating an artificial intervertebral disc (or static
trial) having features suitable for being manipulated by the
inserter/impactors. Exemplary suitable artificial intervertebral
discs are described in the '032 and '327 patents with regard to
FIGS. 8a-z, 9a-u, 10a-u, 11a-k, and 12a-p thereof and by the
accompanying descriptions therefor (e.g., embodiments identified as
the first, second, third, fourth, and fifth preferred embodiments
of the fourth embodiment family, etc.). Regarding the features
suitable for being manipulated by the inserter/impactors, such
features include those discussed above as being suitable features
on the static trials and artificial intervertebral disc, namely, an
anteriorly facing flat surface on the second (e.g., lower)
baseplate of the trial or disc, flanked by two anteriolaterally
facing flat surfaces (one on each side of the anteriorly facing
flat surface), and, to provide for holding of the trial or disc for
an anterior insertion approach, a hole spaced from the anteriorly
facing flat surface, the hole having a longitudinal axis parallel
to the anteriorly facing flat surface.
[0035] The inserter/impactors include a shaft having a distal end
that has angled flat surfaces corresponding to and fittable against
the angled flat surfaces of the static trial or artificial
intervertebral disc, and a holding pin that extends from the center
flat surface along a longitudinal axis of the shaft, the pin having
a distal end that bends downward. The holding pin is spring loaded
in a central channel of the shaft, so that it is biased toward and
against a central flat surface (preferably, the bent end of the pin
prevents it from entering the central channel). A flange,
mechanically connected to the pin and translating adjacent the
shaft, can be pushed distally to overcome the bias of the spring to
space the pin away from the central flat surface. In this position,
the pin can be inserted in the hole in the baseplate of the
artificial intervertebral disc. Releasing the knob allows the
spring to pull the pin back, causing the anteriorly facing surface
of the baseplate to be held against the central flat surface of the
inserter/impactor and the anteriolaterally facing flat surfaces of
the artificial intervertebral disc to be held against the other
corresponding flat surfaces of the inserter/impactor. A knob on the
inserter/impactor can be rotated about the longitudinal axis of the
shaft to pull the pin tighter and lock its position to more
securely hold the baseplate, and reverse rotated to unlock and
loosen the pin. (In some embodiments of the inserter/impactor
having a wedge plate, the holding pin protrudes from a wedge-shaped
extended surface of the distal end of the inserter/impactor and is
restricted from upward movement with respect to the distal head by
the presence of the wedge-shaped extended surface of the distal end
of the inserter/impactor. More particularly, with any attempted
upward movement of the holding pin, the pin encounters the upper
surface of the channel in which the pin travels, preventing any
such upward movement.)
[0036] When the static trial or artificial intervertebral disc is
held in this manner, rotation of the trial or disc about its
longitudinal axis relative to the inserter/impactor is prevented by
interference of the corners of the trial's or disc's flat surfaces
and the corners of the inserter/impactor's flat surfaces, similar
to the manner in which a wrench holding a nut prevents rotation of
the nut relative to the wrench. Further, the holding of the trial
or disc in this manner allows for some repositioning of the trial
or disc in the intervertebral space via rotation of the trial or
disc in either direction about the longitudinal axis of the
intervertebral space. Further, in some embodiments of the
inserter/impactor having a wedge plate, when the trial or disc is
held in this manner, rotation of the trial or disc about a lateral
axis of the trial or disc relative to the inserter/impactor is
prevented by interference of the inwardly facing surface of the
first baseplate (e.g., upper baseplate) of the trial or disc and
the corresponding surface (e.g., upper surface) of the wedge on the
distal end, and by interference of the inwardly facing surface of
the second baseplate (e.g., lower baseplate) of the trial or disc
and the corresponding surface (e.g., lower surface) of the wedge on
the distal end. With regard to artificial discs, it is preferable
that the wedge on the inserter/impactor will interfere between the
first and second baseplates (e.g., upper and lower) so that the
surfaces of the first and second baseplates align at a preferred 15
degrees angle of lordosis when the disc is held by the
inserter/impactor.
[0037] Preferably, both of the baseplates of the static trial or
disc have similarly configured flat surfaces, and both baseplates'
flat surfaces fit against the angled flat surfaces of the
inserter/impactor to provide for a more secure holding of the
static trial or disc by the inserter/impactor. Also preferably, in
order to provide for a holding of the static trial or disc for two
additional (here, anteriolateral) insertion approaches, each static
trial or disc also includes two additional holes, one spaced apart
from one of the anteriolaterally facing flat surfaces, and the
other spaced apart from the other of the anteriolaterally facing
flat surfaces. Accordingly, operation of the inserter/impactor can
fit the holding pin into either of these two additional holes, and
hold the anteriolaterally facing flat surface (the one associated
with the hole into which the pin is fit) of the static trial or
disc against the flat surface of the inserter/impactor opposite the
pin. It should be understood that preferably, in order to
facilitate these two additional approaches, the angle separating
the anteriorly facing flat surface of the static trial or disc and
one of the anteriolaterally facing flat surfaces of the static
trial or disc is equal to the angle separating the anteriorly
facing flat surface and the other of the anteriolaterally facing
flat surfaces.
[0038] Also preferably, as shown, the baseplates of each of the
plurality of static trials are appropriately lordotically angled
relative to one another to ease insertion of the static trial into
the intervertebral space and to mimic how the artificial
intervertebral disc will typically be oriented as it is being
inserted. In some embodiments, the inserter/impactor holds the
artificial intervertebral disc by the lower baseplate such that the
upper baseplate is permitted to adjust its degree of lordosis
relative to the lower baseplate during insertion, as described in
greater detail below. In other embodiments, the inserter/impactor
holds the baseplates in a fixed degree of lordosis relative to one
another, as described in greater detail below.
[0039] With further regard to the repositioners/extractors
described herein, each repositioner/extractor is provided primarily
for repositioning and/or extracting a static trial or artificial
intervertebral disc having features suitable for being manipulated
by the repositioner/extractor. Exemplary suitable artificial
intervertebral discs are described in the '032 and '327 patents
with regard to FIGS. 8a-z, 9a-u, 10a-u, 11a-k, and 12a-p thereof
and by the accompanying descriptions therefor (e.g., embodiments
identified as the first, second, third, fourth, and fifth preferred
embodiments of the fourth embodiment family, etc.). Regarding the
features suitable for being manipulated by each
repositioner/extractor, such features include at least two holes
extending longitudinally into one of the baseplates of the static
trial or artificial intervertebral disc from the inwardly facing
surface of the baseplate. More than two holes can be used to
provide for multiple repositioning/extracting approaches.
Preferably, in order for the same repositioning/extracting tool to
be used for multiple approaches on the same trial or artificial
intervertebral disc, adjacent holes should be separated by the same
distance separating other adjacent holes.
[0040] In order to engage the two holes, each
repositioner/extractor has two pins extending in parallel from a
central shaft, perpendicular to the longitudinal axis of the
central shaft. The pins are spaced to engage the two holes
simultaneously, and each pin has a diameter smaller than the
diameter of the hole it is to engage. Therefore, the pins can be
inserted into the holes, and pulling or pushing on the central
shaft along its longitudinal axis when the holes are engaged pulls
or pushes the static trial or artificial intervertebral disc in the
intervertebral space. Further, because two holes are engaged, the
static trial or artificial intervertebral disc can be rotated in
either direction about a longitudinal axis passing through the
intervertebral space, by rotating of the central shaft of the
repositioner/extractor about its distal end, about an axis parallel
to the longitudinal axes of the pins. A handle at a proximal end of
the central shaft is useful for pushing or pulling on the shaft. A
flange adjacent the proximal end of the shaft is useful for
impaction (either with a distally directed force or a proximally
directed force), if necessary to manipulate the shaft.
[0041] On each repositioner/extractor, the pins are formed on
prongs that extend laterally from the central shaft. The direction
of the prongs, and the location of the pins relative to the central
shaft, determine the angle or angles of surgical approach for which
a particular repositioner/extractor can be used. Further, the
number and location of holes further determine the angle or angles
of surgical approach for which a particular repositioner/extractor
can be used. Accordingly, the present invention contemplates a
variety of repositioner/extractors, and a variety of holes
configurations, to provide the surgeon with a variety of possible
surgical approach angles.
[0042] With further regard to the leveler described herein, the
leveler is provided primarily for establishing a parallel
orientation of the baseplates (relative to one another), and/or
securing the purchase of the stabilizing spikes, of an artificial
intervertebral disc having features suitable for being manipulated
by the leveler. Exemplary suitable artificial intervertebral discs
are described in the '032 and '327 patents with regard to FIGS.
8a-z, 9a-u, 10a-u, 11a-k, and 12a-p thereof and by the accompanying
descriptions therefor (e.g., embodiments identified as the first,
second, third, fourth, and fifth preferred embodiments of the
fourth embodiment family, etc.). Regarding the features suitable
for being manipulated by the leveler, such features include
suitably formed inwardly facing surfaces of the baseplates of the
artificial intervertebral disc.
[0043] More particularly, the leveler includes a shaft having a
forked distal end formed by two opposing tongs that are symmetric
to one another about a longitudinal axis of the shaft. Each of the
tongs has an extent that initially curves laterally outward away
from the shaft and from the other tong's extent, to define a
central pocket forward of the shaft between the tongs' extents.
Each tong's extent then resumes a distal direction to become
parallel to the shaft and to the other tong's extent.
[0044] Each tong's extent has an upper surface and a lower surface.
The upper surface is preferably shaped to conform against the
inwardly facing surface of a first (e.g., upper) baseplate of an
artificial intervertebral disc, and the lower surface is preferably
shaped to conform against the inwardly facing surface of a second
(e.g., lower) baseplate of the artificial intervertebral disc, so
that insertion of the forked distal end of the leveler between the
baseplates, with the central pocket of the distal end avoiding the
central portion of the artificial intervertebral disc, and with the
upper and lower surfaces so engaging the inwardly facing surfaces
of the baseplates, causes the baseplates to be placed in parallel
orientation with respect to one another. A handle is provided at a
proximal end of the shaft for pushing, pulling, and otherwise
manipulating the leveler as needed.
[0045] When the artificial intervertebral disc is inserted into the
intervertebral space, its baseplates will typically be lordotically
angled with respect to one another. The leveler can be applied to
the artificial intervertebral disc to bring the baseplates parallel
to one another. The forked distal end of the leveler is inserted so
that the tongs' extents are placed between the inwardly facing
surfaces of the baseplates, and so that the central pocket of the
leveler avoids that portion of the artificial intervertebral disc
that joins the baseplates. As the leveler is inserted, the tongs
act as wedges to force the posterior portions of the baseplates
away from one another. Accordingly, as the posterior portions are
being separated, the stabilizing spikes on the outwardly facing
surfaces of the baseplates find or secure their purchase in the
hard bone of the outer ring of the vertebral body endplates. When
the forked distal end is fully seated, the extents of the tongs
hold the baseplates parallel to one another, and so that the spikes
are fully engaged in the endplates.
BRIEF DESCRIPTION OF THE DRAWINGS
[0046] FIGS. 1-6 show front (FIG. 1), side (FIG. 2), perspective
(FIG. 3), top (FIG. 4), bottom cutaway (FIG. 5) and top cutaway
(FIG. 6) views of a static trial of the present invention. FIGS.
7-12 show front (FIG. 7), side (FIG. 8), perspective (FIG. 9), top
(FIG. 10), bottom cutaway (FIG. 11), and top cutaway (FIG. 12)
views of an alternate static trial of the present invention.
[0047] FIGS. 13-20 show front (FIG. 13), side cutaway (FIG. 14),
top (FIG. 15), side cutaway (FIG. 16), bottom cutaway (FIG. 17),
top cutaway (FIG. 18), bottom perspective (FIG. 19), and top
perspective (FIG. 20) views of an exemplary artificial
intervertebral disc of the present invention.
[0048] FIGS. 21-31 show top (FIG. 21), side (FIG. 22), perspective
(FIG. 23), disassembly (FIGS. 24-30), and side cutaway (FIG. 31)
views of a static trial holder of the present invention.
[0049] FIGS. 32-34 and 44 show side (FIG. 32), top (FIG. 33),
perspective (FIG. 34), and side cutaway (FIG. 44) views of an
alternate static trial holder 2000 of the present invention.
[0050] FIGS. 35, 36, 37, and 38-39 show a sleeve of the alternate
static trial holder 2000 in side (FIG. 35), top (FIG. 36), side
cutaway (FIG. 37), front (FIG. 38), and back (with partial cutaway)
(FIG. 39) views.
[0051] FIGS. 40-42 show an extension of the alternate static trial
holder 2000 in top (FIG. 40), proximal cutaway (FIG. 41), side
(FIG. 42), and distal cutaway (FIG. 43) views.
[0052] FIGS. 45-47 show top (FIG. 45), side (FIG. 46), and
perspective (FIG. 47) views of the alternate static trial holder of
FIGS. 32-44 holding an alternate static trial of FIGS. 7-12 from an
anterior approach hold.
[0053] FIGS. 48-49 show top views of the alternate static trial
holder of FIGS. 32-44 holding an alternate static trial of FIGS.
7-12 from two anterior-lateral approach holds.
[0054] FIG. 50 shows a perspective view of the alternate static
trial holder of FIGS. 32-44 holding an alternate static trial of
FIGS. 7-12 from the anterior-lateral approach hold of FIG. 49.
[0055] FIGS. 51-54 show side (FIG. 51), top (FIG. 52), side cutaway
(FIG. 53), and perspective (FIG. 54) views of a dynamic trial of
the present invention.
[0056] FIGS. 55-58 show side (FIG. 55), top (FIG. 56), side cutaway
(FIG. 57), and perspective (FIG. 58) views of an inserter/impactor
of the present invention.
[0057] FIGS. 59-62 show side (FIG. 59), top (FIG. 60), side cutaway
(FIG. 61), and perspective (FIG. 62) views of an inserter/impactor
of the present invention holding a static trial of the present
invention.
[0058] FIGS. 63-64 show top views of an inserter/impactor of the
present invention holding a static trial of the present invention
in two alternative ways.
[0059] FIGS. 65-68 show side (FIG. 65), top (FIG. 66), side cutaway
(FIG. 67), and perspective (FIG. 68) views of an inserter/impactor
of the present invention holding an exemplary artificial
intervertebral disc of the present invention.
[0060] FIGS. 69-70 show top views of an inserter/impactor of the
present invention holding an exemplary artificial intervertebral
disc of the present invention in two alternative ways.
[0061] FIGS. 71-73 show side (FIG. 71), perspective (FIG. 72), and
close-up perspective (FIG. 73) views of a wedge plate
inserter/impactor of the present invention.
[0062] FIGS. 74-77 show bottom (FIG. 74), side (FIG. 75), top (FIG.
76), and side cutaway (FIG. 77) views of a distal end of a wedge
plate inserter/impactor of the present invention.
[0063] FIGS. 78-79 show top (FIG. 78) and side (FIG. 79) views of a
wedge plate inserter/impactor of the present invention holding an
exemplary artificial intervertebral disc.
[0064] FIGS. 80-82 show top (FIG. 80), side (FIG. 81), and side
cutaway (FIG. 82) views of a distal end of a wedge plate
inserter/impactor of the present invention holding an exemplary
artificial intervertebral disc.
[0065] FIGS. 83-85 show side (FIG. 83), top (FIG. 84), and
perspective (FIG. 85) views of a symmetric repositioner/extractor
of the present invention.
[0066] FIGS. 86-88 show side (FIG. 86), top (FIG. 87), and
perspective (FIG. 88) views of an offset left
repositioner/extractor of the present invention.
[0067] FIGS. 89-91 show side (FIG. 89), top (FIG. 90), and
perspective (FIG. 91) views of an offset right
repositioner/extractor of the present invention.
[0068] FIGS. 92-94 show side (FIG. 92), top (FIG. 93), and
perspective (FIG. 94) views of an alternative offset left
repositioner/extractor of the present invention.
[0069] FIGS. 95-97 show side (FIG. 95), top (FIG. 96), and
perspective (FIG. 97) views of an alternative offset right
repositioner/extractor of the present invention.
[0070] FIGS. 98-103 show exemplary various possible
repositioner/extractor approach angles with a three hole
configuration of the present invention.
[0071] FIGS. 104-112 show exemplary various possible
repositioner/extractor approach angles with a four hole
configuration of the present invention.
[0072] FIGS. 113-117 show bottom (FIG. 113), side (FIG. 114), front
(FIG. 115), top partial perspective (FIG. 116), and bottom partial
perspective (FIG. 117) views of a leveler of the present
invention.
DETAILED DESCRIPTION
[0073] While the invention will be described more fully hereinafter
with reference to the accompanying drawings, it is to be understood
at the outset that persons skilled in the art may modify the
invention herein described while achieving the functions and
results of the invention. Accordingly, the descriptions that follow
are to be understood as illustrative and exemplary of specific
structures, aspects and features within the broad scope of the
invention and not as limiting of such broad scope. Like numbers
refer to similar features of like elements throughout.
[0074] Preferred embodiment of static trials of the present
invention, and a preferred embodiment of an artificial
intervertebral disc of the present invention, both for use with the
instrumentation of the present invention, will now be
described.
[0075] Referring now to FIGS. 1-6, a static trial of the present
invention is shown in front (FIG. 1), side (FIG. 2), perspective
(FIG. 3), top (FIG. 4), bottom cutaway (FIG. 5) and top cutaway
(FIG. 6) views. Referring now to FIGS. 7-12, an alternate static
trial of the present invention is shown in front (FIG. 7), side
(FIG. 8), perspective (FIG. 9), top (FIG. 10), bottom cutaway (FIG.
11) and top cutaway (FIG. 12) views. Referring now to FIGS. 13-20,
an artificial intervertebral disc of the present invention is shown
in front (FIG. 13), side cutaway (FIG. 14), top (FIG. 15), side
cutaway (FIG. 16), bottom cutaway (FIG. 17), top cutaway (FIG. 18),
bottom perspective (FIG. 19), and top perspective (FIG. 20)
views.
[0076] It should be understood that the illustration and reference
herein to the artificial intervertebral disc shown in FIGS. 13-20
is merely to show an example of one type of artificial
intervertebral disc that is contemplated by, encompassed by, and
suitable for use with, the present invention, and that such
illustration and reference herein is not meant to limit the scope
of the present invention or limit the uses of the present
invention. Rather, any other artificial intervertebral disc (or any
other orthopedic device) having suitable features for being used
with the instrumentation and methods described herein are
contemplated by the present invention. Indeed, the features
suitable for manipulation (e.g., the angled flat surfaces and
adjacent holes and inwardly facing surfaces) are encompassed by the
present invention, regardless of to what orthopedic device they may
be applied. Other exemplary suitable artificial intervertebral
discs include, but are not limited to, the artificial
intervertebral discs described in the '032 and '327 patents with
regard to FIGS. 8a-z, 9a-u, 10a-u, 11a-k, and 12a-p thereof and by
the accompanying descriptions therefor (e.g., embodiments
identified as the first, second, third, fourth, and fifth preferred
embodiments of the fourth embodiment family, etc.). It should be
noted that, as can be seen from FIGS. 13-20, that the artificial
intervertebral disc shown in FIGS. 13-20 has features similar to
those of these other suitable artificial intervertebral discs of
the '032 and '327 patents, and it should be understood that such
similar features are structurally and functionally as described in
the '032 and '327 patents. Such similar features include an
inwardly facing surface 164a of the upper baseplate 164a, and a
convex structure 162 on the lower baseplate 168b, the convex
structure 162 having an inwardly facing surface 164b.
[0077] And, while the instrumentation described herein (e.g., the
static trials, static trial holders, dynamic trial,
inserter/impactors, repositioners/extractors, and leveler) will be
discussed for use with the artificial intervertebral disc of FIGS.
13-20, such discussions are merely by way of example and not
intended to be limiting of their uses. Thus, it should be
understood that the tools can be used with any of the artificial
intervertebral discs disclosed in the '032 and '327 patents, or any
other artificial intervertebral disc having (or being modifiable or
modified to have) suitable features therefor. Moreover, it is
anticipated that the features of the artificial intervertebral disc
(e.g., the angled flat surfaces and accompanying holes and inwardly
facing baseplate surfaces) and/or the static trials (e.g., the
cylindrical trunks and angled flat surfaces and accompanying holes
and/or engagement notches) that are used by the tools discussed
herein to hold and/or manipulate these devices (such features, it
should be noted, were first shown and disclosed in the'182, '132,
'081, '032 and '327 patents) can be applied, individually or
collectively or in various combinations, to other trials, spacers,
artificial intervertebral discs or other orthopedic devices as
stand-alone innovative features for enabling such trials, spacers,
artificial intervertebral discs, or other orthopedic devices to be
more efficiently and more effectively held and/or manipulated by
the tools described herein or by other tools having suitable
features. In addition, it should be understood that the invention
encompasses artificial intervertebral discs, spacers, trials
(static or dynamic), and/or other orthopedic devices, that have one
or more of the features disclosed herein, in any combination, and
that the invention is therefore not limited to artificial
intervertebral discs, spacers, trials, and/or other orthopedic
devices having all of the features simultaneously.
[0078] Referring to FIGS. 1-6 and 7-12, a plurality of static
trials 100,1000 are provided primarily for use in determining the
appropriate size of an artificial intervertebral disc to be
implanted (or whether a particular size of the artificial
intervertebral disc can be implanted) into the distracted
intervertebral space (e.g., the artificial intervertebral disc 160
of FIGS. 13-20). Preferably, for each artificial intervertebral
disc to be implanted, a plurality of sizes of the artificial
intervertebral disc would be available. That is, preferably, a
plurality of the same type of artificial intervertebral disc would
be available, each of the plurality having a respective width and
depth dimension combination that allows it to fit within a
correspondingly dimensioned intervertebral space. For example, the
plurality of artificial intervertebral discs could include
artificial intervertebral discs having widths being either 35 mm or
40 mm, and depths ranging from 14 mm to 18 mm in 1 mm increments,
for a total of 10 discs. Accordingly, preferably, each of the
plurality of static trials 100,1000 for use with a particular
plurality of differently sized artificial intervertebral discs
would have a respective width and depth dimension set corresponding
to the width and depth of a respective one of the plurality of
differently sized artificial intervertebral discs. For example, the
plurality of static trials 100,1000 for use with the set of
artificial intervertebral discs described for example could include
static trials having widths being either 35 mm or 40 mm, and depths
ranging from 14 mm to 18 mm in 1 mm increments, for a total of 10
static trials. It should be understood that the artificial
intervertebral discs and/or the static trials 100,1000 can be
offered in a variety of dimensions without departing from the scope
of the invention, and that the dimensions specifically identified
and quantified herein are merely exemplary. Moreover, it should be
understood that the set of static trials 100,1000 need not include
the same number of trials for each artificial intervertebral disc
in the set of artificial intervertebral discs, but rather, none,
one, or more than one trial can be included in the trial set for
any particular artificial intervertebral disc in the set.
[0079] Each of the static trials 100,1000 shown is exemplary for
all of the static trials in the plurality of static trials;
preferably the static trials in the plurality differ from one
another only with regard to overall dimensions as described above)
includes at least one feature that can be engaged by a tool.
Suitable tools include, but are not limited to, the static trial
holders described below, the inserter/impactors described below,
and the repositioners/extractors described below.
[0080] Specifically, the static trial 100,1000 includes a recess
102,1020 that can be engaged by the opposing semicircular extents
216a-b,2160a-b of the static trial holder 200,2000. Preferably,
this recess 102,1020 forms an annular groove 104,1040 that
establishes a cylindrical trunk 106,1060 between the upper and
lower baseplates 108a-b,1080a-b of the static trial 100,1000, such
that the baseplates 108a-b,1080a-b extend as flanges 110a-b,110a-b
from either end of the cylindrical trunk 106,1060. Accordingly,
preferably, the opposing semicircular extents 216a-b,2160a-b each
have a thickness smaller than the width of the annular groove
104,1040, and as such fit into the annular groove 104,1040 to grip
the cylindrical trunk 106,1060 between them. (Importantly, with
regard to the alternate static trials 1000 being engaged by the
alternate static trial holder 2000, as discussed in greater detail
below, the body of the prongs 2140a-b (from which the semicircular
extents 2160a-b extend) has a thickness greater than the width of
the annular groove 1040 (and as such does not fit within the
annular groove) but small enough to be accommodated by the opposing
notches 1320a-b of the alternate static trial 1000 as described
below.)
[0081] In some embodiments, while not shown in FIGS. 1-6 or FIGS.
7-12, it is also preferable that the annular groove 104,1040
radially widen outwardly, such that the walls 112,1120 of the
annular groove 104,1040 are tapered toward one another with the
increasing depth of the groove 104,1040, such that the floor
114,1140 of the groove 104,1040 is more narrow than the opening
116,1160 of the groove 104,1040. Accordingly, preferably, in such
embodiments, each semicircular extent 216a-b,2160a-b
correspondingly radially widens outwardly, such that the thinner
portion of the extent 216a-b,2160a-b fits closer to the floor
114,1140 of the annular groove 104,1040, so that the tapered
surfaces of the extents 216a-b,2160a-b compress against the tapered
walls 112,1120 of the annular groove 104,1040 when the static trial
100,1000 is engaged by the static trial holder 200,2000. This taper
locking provides for a secure grip so that the static trial
100,1000 can be manipulated accurately and efficiently.
[0082] In some embodiments, while not shown in FIGS. 1-6 or FIGS.
7-12, it is also preferable that the floor of the annular groove
104,1040 of the cylindrical trunk 106,1060 be ridged (e.g., have
ridges that run parallel to the longitudinal axis of the
cylindrical trunk), and the surfaces of the semicircular extents
216a-b,2160a-b of the static trial holder 200,2000 that compress
against the floor of the annular groove 104,1040 when the static
trial holder 200,2000 grips the static trial 100,1000 be
correspondingly provided with ridges. The interlocking of the
ridges of the static trial 100,1000 with the ridges of the static
trial holder 200,2000 when the static trial 100,1000 is engaged
prevents rotation of the static trial 100,1000 about the
longitudinal axis of the cylindrical trunk 106,1060 with respect to
the static trial holder 200,2000.
[0083] Preferably, as shown in FIGS. 7-12, each alternate static
trial 1000 includes (on any alternate static trial surface that
faces the desired engagement approach direction of the alternate
static trial holder 2000) opposing recesses, preferably formed as
upper and lower notches, an upper notch in the upper baseplate and
a lower notch in the lower baseplate. For example, opposing notches
1320b and 1320e are on each of the anteriorly facing flat surfaces
of the upper 1080a and lower 1080b baseplates. And, for example,
opposing notches 1320a and 1320d are on one of the
anterior-laterally facing flat surfaces of the upper 1080a and
lower 1080b baseplates. And, for example, opposing notches 1320c
and 1320f are on the other of the anterior-laterally facing flat
surfaces of the upper 1080a and lower 1080b baseplates. Preferably,
the notches 1320a-f are sized so that the opposing notches of each
pair (1320a,d, 1320b,e, and 1320c,f) form a volume that closely
accommodates the dimensions of the alternate static trial holder's
2000 prongs' 2140a-b cross-section. That is, as described below,
the body of each prong 2140a-b is thicker than the semicircular
extent 2160a-b that extends from the body, and as such, whereas the
semicircular extents 2160a-b fit into the annular groove 1040, the
prongs 2140a-b do not because the depth 2260 of their cross-section
(described below) is greater than the width of the annular groove
opening 1160. However, each notch pair (1320a,d, 1320b,e, and
1320c,f) accommodates this greater thickness, in that each notch
1320a-f has a depth 1340, and, when the two notch depths 1340 of
the opposing notches of the notch pair are taken together with the
width of the annular groove 1040, the combined distance
accommodates the depth 2260 of the static trial holder's 2000
prongs' 2140a-b cross-section. Further, each notch 1320a-f has a
width 1360 that accommodates the width 2240 of the alternate static
trial holder's 2000 prongs' 2140a-b cross-section. (It should be
noted that the width 1360 accommodates the width 2240 of the
alternate static trial holder's 2000 prongs' 2140a-b cross-section
even when the prongs 2140a-b are separated to place the holding
enclosure 2100 in an expanded state as described below. This
enables the notches 1320a-f to accommodate the width 2240 of the
prongs' cross-section as the cylindrical trunk 1060 of the static
trial 1000 is being snapped into the holding enclosure 2100 as
described below.) As such, as the opposing semicircular extents
2160a-b of the alternate static trial holder 2000 are placed into
the annular groove 1040, the bodies of the prongs 2140a-b pass into
the notches of the pair so that the semicircular extents 2160a-b
can continue into the annular groove 1040 and be seated around the
cylindrical trunk 1060. More specifically, the prongs 2140a-b of
the alternate static trial holder 2000 fit into the notches above
and below it (e.g., 1320b and 1320e for an anterior approach; 1320a
and 1320d for an anterior-lateral approach; and 1320c and 1320f for
another anterior-lateral approach). Once the prongs 2140a-b are
fitted within the notch pair, interference between the prongs
2140a-b and the notch walls limits or prevents rotation of the
alternate static trial 1000 about a longitudinal axis (e.g., an
axis parallel to the longitudinal axis of the cylindrical trunk
1060) with respect to the alternate static trial holder 2000.
[0084] It should be understood that configurations having more or
fewer notches, and in a variety of locations, are contemplated by
the invention, and the detailed descriptions of only one type of
notch configuration is not meant to limit the invention to only
this configuration. Importantly, the invention encompasses using a
single notch in a baseplate, a single notch pair, or any number of
notches or notch pairs, formed in any suitable manner with any
suitable dimensions, in any number of locations on a spacer, a
trial or an artificial intervertebral disc (not limited to
locations on the baseplates), for purposes of enabling the spacer,
trial, or disc to be engaged by a manipulation instrument (not
limited to a static trial holder) that engages the notch, for the
purpose of limiting rotation of the spacer, trial, or disc (or
other orthopedic implant) with respect to the instrument or for any
other purpose, and/or to enable the surgeon to work from a variety
of approaches. For example, the notch configuration described
herein, in cooperation with the alternate static trial holder,
provides the surgeon with the ability to work from a directly
anterior approach, as well as two anteriolateral approaches. It
should be understood that additional notch configurations can
enable the surgeon to work from a directly posterior approach,
posteriolateral approaches, directly lateral approaches, or
anteriolateral approaches that are different than those
illustrated. For example, the placement of one or more suitably
spaced notches (or the addition of one or more notches) on the
posterior edge, and/or one or both of the lateral edges of one or
both of the baseplates, would enable the surgeon to use the
alternate static trial holder of the present invention to achieve
such approaches.
[0085] Additionally with regard to features that can be engaged by
a tool, each of the static trials 100,1000 includes at least one
feature that can be engaged by a tool that preferably is also used
to engage the artificial intervertebral disc that the trial
approximates. Suitable tools that can engage both the trials and
the artificial intervertebral disc include, but are not limited to,
the inserter/impactors described below. Specifically, for being
engaged by the inserter/impactors 400,4000, each static trial
100,1000 and artificial intervertebral disc 160 includes an
anteriorly facing flat surface 120b,1200b,180b, flanked by two
anteriolaterally facing flat surfaces 120a,1200a,180a and
120c,1200c,180c (one on each side of the anteriorly facing flat
surface 120b,1200b,180b), and, to provide for holding of the static
trial 100,1000 or disc 160 for an anterior insertion approach, a
hole 122b,1220b,182b spaced from the anteriorly facing flat surface
120b,1200b,180b, the hole 122b,1220b,182b having a longitudinal
axis parallel to the anteriorly facing flat surface
120b,1200b,180b.
[0086] The holding pin 408,4080 of the inserter/impactor 400,4000
fits within the hole 122b,1220b,182b, and the angled flat surfaces
120a-c,1200a-c,180a-c of the static trial 100,1000 or disc 160 fit
against the correspondingly angled flat surfaces 420a-c,4200a-c of
the inserter/impactor 400,4000, and operation of the
inserter/impactor 400,4000 pulls the holding pin 408,4080 toward
the flat surface 120b,1200b,180b of the inserter/impactor 400,4000
opposite the pin 408,4080, to rigidly hold the static trial
100,1000 or disc 160 by the structure of the static trial 100,1000
or disc 160 having the hole 122b,1220b,182b (e.g., the baseplate
108b,1080b,168b).
[0087] When the static trial 100,1000 or disc 160 is held in this
manner, rotation of the static trial 100,1000 or disc 160 about a
longitudinal axis (of the static trial 100,1000 or disc 160)
relative to the inserter/impactor 400,4000 is prevented by
interference of the corners of the static trial's 100,1000 or
disc's 160 flat surfaces 120a-c,1200a-c,180a-c and the corners of
the inserter/impactor's 400,4000 flat surfaces 420a-c,4200a-c,
similar to the manner in which a wrench holding a nut prevents
rotation of the nut relative to the wrench. Further, the holding of
the static trial 100,1000 or disc 160 in this manner allows for
some repositioning of the static trial 100,1000 or disc 160 in the
intervertebral space via rotation of the static trial 100,1000 or
disc 160 in either direction about the longitudinal axis of the
intervertebral space.
[0088] Further, with regard to the wedge plate inserter/impactor
4000, when the static trial 100,1000 or disc 160 is held in this
manner, rotation of the static trial 100,1000 or disc 160 about a
lateral axis (of the static trial 100,1000 or disc 160) relative to
the inserter/impactor 4000 is prevented by interference of the
inwardly facing surface (e.g., 164a) of the first baseplate (e.g.,
upper baseplate) of the static trial 100,1000 or disc 160 and the
upper surface 4200g of the wedge on the distal end 4040, and by
interference of the inwardly facing surface (e.g., 164b) of the
second baseplate (e.g., lower baseplate) of the static trial
100,1000 or disc 160 and the lower surface 4200h of the wedge on
the distal end 4040. Accordingly, the holding of the static trial
100,1000 or disc 160 in this manner allows for some repositioning
of the static trial 100,1000 or disc 160 in the intervertebral
space via rotation of the static trial 100,1000 or disc 160 in
either direction about the longitudinal or latitudinal axis of the
intervertebral space.
[0089] Preferably, both of the baseplates of the static trial
100,1000 or disc 160 have similarly configured flat surfaces. For
example, the lower baseplate's 108b,1080b,168b flat surfaces
120a-c,1200a-c,180a-c have similarly configured and similarly
oriented counterpart flat surfaces 120d-f,1200d-f,180d-f on the
upper baseplate 108a,1080a,168a. Further preferably, both
baseplates' 108a-b,1080a,168a-b flat surfaces 120a-f,1200a-f,180a-f
face the angled flat surfaces 420a-c,4200a-f of the
inserter/impactor 400,4000 when the static trial 100,1000 or disc
160 is held by the inserter/impactor 400,4000. For example, in an
anterior approach for the trial 100,1000 (as shown in FIGS. 59-62,
showing the trial 100 being held by the inserter/impactor 400 as an
example for of how either trial 100,1000 can be held by either
inserter/impactor 400,4000), 120a,1200a and 120d,1200d facing 420a
(or 4200a and 4200d), 120b,1200b and 120e,1200e facing 420b (or
4200b and 4200e), and 120c,1200c and 120f,1200f facing 420c (or
4200c and 4200f), and in an anterior approach for the disc 160 (as
shown in FIGS. 65-68, showing the disc 160 being held by the
inserter/impactor 400 as an example for of how the disc 160 can be
held by either inserter/impactor 400,4000), 180a and 180d facing
420a (or 4200a and 4200d), 180b and 180e facing 420b (or 4200b and
4200e), and 180c and 180f facing 420c (or 4200c and 4200f).
[0090] It should be noted that preferably, when the static trial
100,1000 is held by the inserter/impactor 400,4000, the flat
surfaces 120a-c,1200a-c and the counterpart flat surfaces
120d-f,1200d-f are tightly held against the angled flat surfaces
420a-c,4200a-f of the inserter/impactor 400,4000 as described
above. It is also preferable that the baseplates 108a-b,1080a-b of
each of the plurality of static trials 100,1000 be appropriately
lordotically angled relative to one another to ease insertion of
the static trial 100,1000 into the intervertebral space and to
mimic how the artificial intervertebral disc 160 will typically be
oriented as it is being inserted using the inserter/impactor
400,4000. While not shown in FIGS. 1-6 or FIGS. 7-12, in some
embodiments, when the static trials 100,1000 are formed in such a
lordotically oriented configuration, it is preferable that the flat
surfaces 120d-f,1200d-f on the first (e.g., upper) baseplate
108a,1080a be parallel to the flat surfaces 120a-c,1200a-c of the
second (e.g., lower) baseplate 108b,1080b in the static trial's
100,1000 appropriately lordotically oriented configuration, so that
when the static trial 100,1000 is held tightly by the
inserter/impactor 400,4000, the flat surfaces 120a-f,1200a-f are
flush with the flat surfaces 420a-c,4200a-f of the
inserter/impactor 400,4000 even though the baseplates
108a-b,1080a-b are lordotically angled with respect to one
another.
[0091] With regard to the inserter/impactor 400, by contrast,
preferably, when the artificial intervertebral disc 160 is held by
the inserter/impactor 400, the flat surfaces 180a-c are tightly
held against the angled flat surfaces 420a-c of the
inserter/impactor 400 as described above, but the counterpart flat
surfaces 180d-f are loosely held against the angled flat surfaces
420a-c of the inserter/impactor 400. As such, the structure of the
artificial intervertebral disc 160 having the counterpart flat
surfaces 180d-f (e.g., the upper baseplate 168a) is able to
angulate and rotate to a limited extent relative to the structure
of the artificial intervertebral disc 160 having the flat surfaces
180a-c. This permits the artificial intervertebral disc 160 to
adjust to the intervertebral space (e.g., to the angulation of the
adjacent vertebral endplates, defining the intervertebral space,
relative to one another) as it is being inserted thereinto. That
is, typically, the adjacent vertebral endplates will be
lordotically angled with respect to one another as a result of the
intervertebral space being prepared and distracted. As the
artificial intervertebral disc 160 is then inserted into the
intervertebral space using the inserter/impactor 400, then, the
baseplates 168a-b will be permitted to lordotically angle with
respect to one another to squeeze into the intervertebral
space.
[0092] With regard to the wedge plate inserter/impactor 4000, when
the artificial intervertebral disc 160 is held by the
inserter/impactor 4000, the wedge surfaces of the distal end 4040
protrude from a distance midway with respect to the top and bottom
of the distal end 4040 and span (e.g., right to left or vice-versa)
the entire distal face of the distal end 4040, and the surfaces
4200d-f above the wedge on the distal end 4040 are respectively
perpendicular to the wedge's upper surface 4200g such that each is
disposed in parallel with its respective corresponding surface of
the disc 160 when the disc 160 is held by the inserter/impactor
4000 at the appropriate lordosis angle. (And, accordingly, are
angled approximately 15 degrees with respect to the surfaces below
the wedge 4200a-c.)
[0093] Preferably, for an anterior approach, the wedge-shaped
extension 4042 is designed and shaped to fit with its
antero-lateral confronting surfaces (4200d,f and 4200a,c) tightly
against the correspondingly antero-laterally facing surfaces
(180d,f and 180a,c) of the disc 160, but such that its anterior
confronting surfaces (4200e and 4200b) are slightly spaced from the
anteriorly facing surfaces (180d and 180b) of the disc 160, when
the disc is held by the inserter/impactor 4000. This is primarily
to address manufacturing issues (in some instances, tolerances may
not be adequately defined to ensure that all of those surfaces fit
tightly against their corresponding surfaces), so that if there are
manufacturing anomalies, any slight tolerance differences that may
exist are nevertheless still adequate to ensure at least the tight
fitting of the antero-lateral confronting surfaces, so that
manipulation of the disc 160 is possible (e.g., in the manner of a
wrench against an angled nut). This can be achieved, e.g., by
designing the anterior confronting surfaces (4200e and 4200b) to
each be slightly greater in length than the corresponding
anteriorly facing surfaces (180e and 180b) of the disc baseplates,
while still being angled with respect to the antero-lateral
confronting surfaces (4200d,f and 4200a,c) at the same angle the
antero-laterally facing surfaces (180d,f and 180a,c) of the disc
baseplates are angled with respect to the anteriorly facing
surfaces (180e and 180b) of the disc. The increased length of the
anterior confronting surfaces on the wedge extension results in the
slight clearance between the anteriorly facing surfaces (180e and
180b) of the disc and the corresponding anterior confronting
surface (4200e and 4200b) of the wedged distal end, thereby
ensuring that the disc will be fully seated against the
antero-lateral confronting surfaces of the distal end despite
possible manufacturing, material or other inevitable variations in
tolerances of the artificial intervertebral disc or the
inserter/impactor. As noted above, similar in this regard to the
manner in which a wrench engages a nut, this fitting increases the
mechanical advantage toward repositioning the disc in the
intervertebral space. It should be noted, inasmuch as the
inserter/impactor 4000 described herein can engage the disc from
the antero-lateral angles as well, the anterior confronting
surfaces (4200e and 4200b) should also be longer than the
antero-laterally facing surfaces (180d,f and 180a,c) of the disc,
so that a similar fitting occurs when the disc is held from the
antero-lateral angles. Stated broadly, the primary confronting
surfaces (e.g., the anterior confronting surfaces) of the
inserter/impactor are preferably slightly longer than the primary
confronted surfaces (e.g., anteriorly facing surfaces) of the disc
for any given holding orientation.
[0094] In order to provide for a holding of the static trial
100,1000 or disc 160 for two additional (here, anteriolateral)
insertion approaches, each static trial 100,1000 or disc 160 also
preferably includes two additional holes 122a,1220a,182a and
122c,1220c,182c, one (e.g., 122a,1220a,182a) spaced apart from one
of the anteriolaterally facing flat surfaces (e.g.,
120a,1200a,180a), and the other (e.g., 122c,1220c,182c) spaced
apart from the other of the anteriolaterally facing flat surfaces
(e.g., 120c,1200c,180c). Accordingly, operation of the
inserter/impactor 400,4000 can fit the holding pin 408,4080 into
either of these two additional holes 122a,1220a,182a or
122c,1220c,182c, and hold the associated anteriolaterally facing
flat surface (the one associated with the hole into which the pin
408,4080 is fit) of the static trial 100,1000 or disc 160 against
the flat surface of the inserter/impactor 400,4000 opposite the pin
408,4080. For example, in a first anteriolateral approach for the
trial 100,1000 (as shown in FIG. 63 as an example of how either
trial 100,1000 can be engaged by either inserter/impactor
400,4000), 120a,1200a and 120d,1200d not confronted, 120b,1200b and
120e,1200e facing 420a (or 4200a and 4200d), and 120c,1200c and
120f,1200f facing 420b (or 4200b and 4200e), and a first
anteriolateral approach for the disc 160 (as shown in FIG. 69 as an
example of the how the disc 160 can be engaged by either
inserter/impactor 400,4000), 180a and 180d not confronted, 180b and
180e facing 420a (or 4200a and 4200d), and 180c and 180f facing
420b (or 4200b and 4200e). And, for example, in a second
anteriolateral approach for the trial 100 (as shown in FIG. 64 as
an example of how either trial 100,1000 can be engaged by either
inserter/impactor 400,4000), 120a,1200a and 120d,1200d facing 420b
(or 4200b and 4200e), 120b,1200b and 120e,1200e facing 420c (or
4200c and 4200f), and 120c,1200c and 120f,1200f not confronted, and
a second anteriolateral approach for the disc 160 (as shown in FIG.
70 as an example of how the disc 160 can be engaged by either
inserter/impactor 400,4000), 180a and 180d facing 420b (or 4200b
and 4200e), 180b and 180e facing 420c (or 4200c and 4200f), and
180c and 180f not confronted.
[0095] It should be understood that preferably, in order to
facilitate these additional approaches, the angle separating the
anteriorly facing flat surface of the static trial 100,1000 or disc
160 and one of the anteriolaterally facing flat surfaces of the
static trial 100,1000 or disc 160 is equal to the angle separating
the anteriorly facing flat surface and the other of the
anteriolaterally facing flat surfaces. Preferably, the surfaces are
angled with respect to one another at an angle of 33.4 degrees.
[0096] It should also be understood that the inclusion of
additional adjacent angulated surfaces and/or additional notches
(or placing the angulated surfaces or notches in other locations on
the trial or disc), and/or including corresponding holes adjacent
to such angulated surfaces or notches, can provide the surgeon with
additional approaches, e.g., other anteriolateral approaches,
directly lateral approaches, posteriolateral approaches, and/or
directly posterior approaches. For example, a trial or disc can
have angled surfaces (and corresponding holes) along the entire
perimeter of one or both of the baseplates, and thus enable the
surgeon to engage the trial or disc from a number of angles,
including anterior, posterior, lateral, anteriolateral, and
posteriolateral angles. Or, for example, a trial (or disc) can have
notches located on directly laterally facing surfaces or posterior
surfaces or posterior-laterally facing surfaces, and thus enable
the surgeon to engage the trial (or disc) with a static trial
holder from a number of angles, including anterior, posterior,
lateral, anteriolateral, and posteriolateral angles. (It should be
noted that, while the opposing notches of the alternate static
trials are shown formed in conjunction with the angulated surfaces
of the baseplates, neither the number nor the placement of the
opposing notches need coincide or be related to the number or
placement of the angulated surfaces of the baseplates. For example,
the notches can be applied to a trial or disc having curved
approach surfaces.)
[0097] Additionally with regard to features that can be engaged by
a tool, each of the static trials 100,1000 includes at least one
feature that can be engaged by a tool that preferably is also used
to engage the artificial intervertebral disc that the trial
approximates. Suitable tools that can engage both the trial and the
artificial intervertebral disc include, but are not limited to, the
repositioners/extractors 500,510,520,530,540 described below.
Specifically, for being engaged by the repositioners/extractors,
each static trial 100,1000 and artificial intervertebral disc 160
includes at least two holes extending longitudinally into one of
the baseplates of the static trial 100,1000 or artificial
intervertebral disc 160 from the inwardly facing surface of the
baseplate. More than two holes can be used to provide for multiple
repositioning/extracting approaches. Preferably, in order for the
same repositioning/extracting tool to be used for multiple
approaches on the same trial or artificial intervertebral disc,
adjacent holes should be separated by the same distance separating
other adjacent holes.
[0098] As discussed in greater detail below with regard to the
repositioners/extractors 500,510,520,530,540, in order to engage
two of the holes, each repositioner/extractor has two pins
extending in parallel from a central shaft, perpendicular to the
longitudinal axis of the central shaft. The pins are spaced to
engage the two holes simultaneously, and each pin has a diameter
smaller than the diameter of the hole it is to engage. Therefore,
the pins can be inserted into the holes, and pulling or pushing on
the central shaft along its longitudinal axis when the holes are
engaged pulls or pushes the static trial or artificial
intervertebral disc in the intervertebral space. Further, because
two holes are engaged, the static trial or artificial
intervertebral disc can be rotated in either direction about a
longitudinal axis passing through the intervertebral space, by
rotating the central shaft of the repositioner/extractor about its
distal end, about an axis parallel to the longitudinal axes of the
pins. A handle at a proximal end of the central shaft is useful for
pushing or pulling on the shaft. A flange adjacent the proximal end
of the shaft is useful for impaction (either with a distally
directed force or a proximally directed force), if necessary to
manipulate the shaft.
[0099] On each repositioner/extractor, the pins are formed on
prongs that extend laterally from the central shaft. The direction
of the prongs, and the location of the pins relative to the central
shaft, determine the angle or angles of surgical approach for which
a particular repositioner/extractor can be used. Further, the
number and location of holes further determine the angle or angles
of surgical approach for which a particular repositioner/extractor
can be used. Accordingly, the present invention contemplates a
variety of repositioner/extractors, and a variety of holes
configurations, to provide the surgeon with a variety of possible
surgical approach angles.
[0100] As described in greater detail below, three
repositioner/extractors are illustrated and described (symmetric,
offset left, and offset right) for example, and, for example, two
hole configurations are illustrated and described. Referring again
to FIGS. 1-20 and FIGS. 7-12, a first hole configuration includes
the hole configuration described above, that is, three holes on one
of the baseplates (e.g., the lower baseplate 108b,1080b,168b), the
holes being configured so that a first hole 122b,1220b,182b is
located in the anterior-posterior plane, and the adjacent (second
122a,1220a,182a and third 122c,1220c,182c) holes are located in
respective opposing anteriolateral planes on either side of the
first hole 122b,1220b,182b. (This hole configuration is also shown
in FIGS. 98-103, each of which shows a top cutaway view of the
artificial intervertebral disc 160 of FIGS. 13-20, showing its
lower baseplate 168b, having the first hole configuration, engaged
by one of the repositioners/extractors 500,510,520. Each view of
the lower baseplate 168b shows the first hole 182b, the second hole
182a, and the third hole 182c of the first hole configuration.)
[0101] Referring again to FIGS. 1-20, a second hole configuration
includes four holes on one of the baseplates (e.g., the upper
baseplate 108a,168a), the holes being configured so that first
(e.g., 130c,190c) and second (e.g., 130b,190b) holes straddle the
anterior-posterior plane, a third hole (e.g., 130d,190d) is located
so that the third hole and the first hole straddle one of the
opposing anteriolateral planes, and a fourth hole (e.g., 130a,190a)
is located so that the fourth hole and the second hole straddle the
other of the opposing anteriolateral planes. While this second hole
configuration is not illustrated with regard to the static trials
1000, it should be understood that the static trials 1000 can be
configured with such second hole configuration, or any other hole
configuration, without departing from the scope of the present
invention. (It should be noted that, while the opposing notches of
the static trials 1000 are shown formed in conjunction with the
holes in the baseplates, neither the number nor the placement of
the opposing notches need coincide or be related to the number or
placement of the holes in the baseplates.) (This second hole
configuration is also shown in FIGS. 104-112, each of which shows a
bottom cutaway view of the artificial intervertebral disc of FIGS.
1-20, showing its upper baseplate 168a, having the second hole
configuration, engaged by one of the repositioners/extractors
500,510,520. Each view of the upper baseplate shows the first hole
190c, the second hole 190b, the third hole 190d, and the fourth
hole 190a, of the second hole configuration.)
[0102] It should be understood that configurations having more or
fewer holes, and in a variety of locations, are contemplated by the
invention, and the detailed descriptions of only two hole
configurations is not meant to limit the invention to only these
two configurations. Importantly, the invention encompasses using a
hole or any number of holes, bored at any suitable angle, whether
parallel to other holes or not, in any number of locations on a
spacer, a trial or an artificial intervertebral disc (not limited
to locations on the baseplates), for purposes of enabling the
spacer, trial, or disc to be engaged by a manipulation instrument
(not limited to a repositioner/extractor) that engages the hole,
and/or to enable the surgeon to work from a variety of approaches.
For example, as described in more detail below, the first and
second hole configurations described herein, in cooperation with
the repositioner/extractors, provide the surgeon with the ability
to work from a directly anterior approach, as well as several
anteriolateral approaches. It should be understood that additional
hole configurations can enable the surgeon to work from a directly
posterior approach, posteriolateral approaches, directly lateral
approaches, or anteriolateral approaches that are different that
those illustrated. For example, the placement of one or more
suitably spaced holes (or the addition of one or more holes) on the
posterior edge, and/or one or both of the lateral edges of one or
both of the baseplates, would enable the surgeon to use the
repositioner/extractors of the present invention to achieve such
approaches.
[0103] Thus, it can be seen that each of the
repositioner/extractors can be used in more than one manner
depending on the tool desired and the approach desired. These
manners are described in greater detail below and illustrated in
FIGS. 98-112 with regard to the detailed description of the
repositioners/extractors.
[0104] Also preferably, the baseplates 108a-b,1080a-b of each of
the plurality of static trials 100,1000 preferably has a convex
dome 124a-b,1240a-b on its outwardly facing surface 126a-b,1260a-b
that is shaped like the convex dome 184a-b on the outwardly facing
surface 186a-b of the corresponding baseplate 168a-b of the
artificial intervertebral disc 160 that the static trial 100,1000
approximates. Preferably, each convex dome 124a-b,1240a-b is
smooth, rather than having a porous coating that is preferred for
the convex domes 184a-b of the artificial intervertebral disc 160,
and each outwardly facing surface 126a-b,1260a-b does not have
stabilizing spikes such as the stabilizing spikes 188a-b on the
outwardly facing surfaces 186a-b of the artificial intervertebral
disc 160. The omission of these device stabilizing and bone
ingrowth encouraging structures and surfaces on the static trials
100,1000 enables the surgeon to test the size of the artificial
intervertebral disc 160 to be implanted without traumatically
engaging the vertebral body endplates.
[0105] Accordingly, the surgeon can prepare and distract the
intervertebral space, and then insert and remove at least one of
the static trials (or more, as necessary) to find the size that is
most appropriate for the intervertebral space.
[0106] Preferred embodiments of static trial holders of the present
invention will now be described.
[0107] Referring to FIGS. 21-23 and 31, a static trial holder 200
of the present invention is shown in side (FIG. 21), top (FIG. 22),
perspective (FIG. 23), and side cutaway (FIG. 31) views. In
addition, referring to FIGS. 24-26, a sleeve of the static trial
holder is shown in side cutaway (FIG. 24), front (FIG. 25), and
back (with partial cutaway) (FIG. 26) views. In addition, referring
to FIGS. 27-29, an extension of the static trial holder is shown in
top (FIG. 27), proximal cutaway (FIG. 28), side (FIG. 29), and
distal cutaway (FIG. 30) views.
[0108] Referring to FIGS. 32-34 and 44, an alternate static trial
holder 2000 of the present invention is shown in side (FIG. 32),
top (FIG. 33), perspective (FIG. 34), and side cutaway (FIG. 44)
views. In addition, referring to FIGS. 35, 36, 37, and 38-39, a
sleeve of the alternate static trial holder 2000 is shown in side
(FIG. 35), top (FIG. 36), side cutaway (FIG. 37), front (FIG. 38),
and back (with partial cutaway) (FIG. 39) views. In addition,
referring to FIGS. 40-42, an extension of the alternate static
trial holder 2000 is shown in top (FIG. 40), proximal cutaway (FIG.
41), side (FIG. 42), and distal cutaway (FIG. 43) views.
[0109] The static trial holders 200,2000 are provided primarily for
use in holding, inserting and removing the static trials 100,1000
described herein, or distraction spacers having suitable features
therefor, such as the distraction spacers disclosed in the '127
application.
[0110] More specifically, each static trial holder 200,2000
includes a handle 202,2020, an extension 204,2040, and a sleeve
206,2060. As shown in FIGS. 31 and 44, the handle 202,2020 and the
extension 204,2040 are fixed to one another (preferably by the
distal end of the handle 202,2020 being fixed to the proximal end
of the extension 204,2040) to form a shaft 208,2080. The sleeve
206,2060 surrounds the extension 204,2040 and is rotatable with
respect to the handle 202,2040 and the extension 204,2040 about the
longitudinal axis of the shaft 208,2080. The handle 202,2020
preferably has an flange 232,2320 at its proximal end for use in
applying a distally or proximally directed force to position the
static trial 100,1000 (or distraction spacer) into or out of the
intervertebral space, and/or for use in helping the surgeon rotate
the sleeve 206,2060 with respect to the extension 204,2040 (by
engaging the flange 232,2320 and the control knob 219,2190
described below).
[0111] The distal end of the extension 204,2040 forms a
contractable and expandable holding enclosure 210,2100 in that the
distal end is divided at a fulcrum 212,2120 into two prongs
214a-b,2140a-b, each of which terminates in a semicircular extent
216a-b,2160a-b, each of which has a tapered end 215a-b,2150a-b. The
extents 216a-b,2160a-b are oriented such that the tapered ends
215a-b,2150a-b face one another to define a radially inwardly
tapering mouth 213,2130, and such that the semicircular openings
oppose one another to define the holding enclosure 210,2100. The
prongs 214a-b,2140a-b are spring biased toward a neutral position
(preferably by the formation of the fulcrum 212,2120 in combination
with the strength of the material of which the extension 204,2040
is made) such that the holding enclosure 210,2100 is spring biased
to a receptive state (described below), but the prongs
214a-b,2140a-b can be brought together to contract the holding
enclosure 210,2100 to a contracted state, (described below) or the
prongs 214a-b,2140a-b can be further separated to expand the
holding enclosure 210,2100 to an expanded state (described
below).
[0112] When the holding enclosure 210,2100 is in the receptive
state, the width of the mouth 213,2130 of the holding enclosure
210,2100 does not accommodate the diameter of the cylindrical trunk
106,1060 of the static trial 100,1000 (or distraction spacer) for
passage therethrough. However, from this receptive state, the mouth
213,2130 can be temporarily widened (placing the holding enclosure
210,2100 in its expanded state) to accommodate the diameter (for
passage of the cylindrical trunk 106,1060 through the mouth
213,2130), if a sufficient force is applied to overcome the neutral
position bias of the prongs 214a-b,2140a-b and thus widen the mouth
213,2130. (Preferably, there is enough space between the outer
surfaces of the prongs 214a-b,2140a-b and the inner surface of the
bore 218,2180 of the sleeve, when the prongs 214a-b,2140a-b are in
their neutral position, so that the prongs 214a-b,2140a-b can be
separated without interference.) The sufficient force can be
applied by pressing the cylindrical trunk 106,1060 against the
tapered ends 215a-b,2150a-b of the mouth 213,2130, in that the
separating force component of the radially inward force of the
pressing will be applied to the semicircular extents 216a-b,2160a-b
by the taper of the tapered ends 215a-b,2150a-b. Because the
holding enclosure 210,2100 is biased toward the receptive state,
after the cylindrical trunk 106,1060 is passed through the mouth
213,2130 and into the holding enclosure 210,2100, the holding
enclosure 210,2100 will return to its receptive state in which the
width of the mouth 213,2130 does not allow passage of the
cylindrical trunk 106,1060 without the sufficient force.
Preferably, the force required to widen the mouth 213,2130 is
greater than gravity and/or the greatest force that will be
experienced by moving the static trial holder 200,2000 prior to
placing the holding enclosure 210,2100 in the contracted state.
Therefore, once the cylindrical trunk 106,1060 is in the holding
enclosure 210,2100, even before the holding enclosure 210,2100 is
placed in its contracted state, the cylindrical trunk 106,1060 will
not escape the holding enclosure 210,2100 as the static trial
holder 200,2000 is oriented with the holding enclosure 210,2100
downward, or is moved about.
[0113] It should be understood that when the static trial 100,1000
(or distraction spacer) is being held (either when the holding
enclosure 210,2100 is in its receptive state or in its contracted
state discussed below), because the semicylindrical extents
216a-b,2160a-b fit within the annular groove 104,1040 of the static
trial 100,1000 (or distraction spacer), the static trial 100,1000
(or distraction spacer) will not escape from the enclosure along
the longitudinal axis of the cylindrical trunk 106,1060. That is,
as noted above, the recess 102,1020 of each static trial 100,1000
(or distraction spacer) forms an annular groove 104,1040 that
establishes the cylindrical trunk 106,1060 between the baseplates
of the static trial (or distraction spacer), such that the
baseplates extend as flanges from either end of the cylindrical
trunk 106,1060. Accordingly, preferably, the opposing semicircular
extents each have a thickness smaller than the width of the annular
groove 104,1040, and as such fit into the annular groove 104,1040
to engage the cylindrical trunk 106,1060 between them.
[0114] In some embodiments, while not shown in FIGS. 1-6 or FIGS.
7-12 or FIGS. 21-31 or FIGS. 32-44, it is preferable that the
annular groove 104,1040 radially widen outwardly, such that the
walls of the annular groove 104,1040 taper toward one another with
the increasing depth of the groove, such that the floor of the
groove is more narrow than the opening 116,1160 of the groove.
Accordingly, preferably, in such embodiments, each semicircular
extent 216a-b,2160a-b correspondingly radially widens outwardly,
such that the thinner portion of the extent 216a-b,2160a-b fits
closer to the floor of the annular groove 104,1040, so that the
tapered surfaces 215a-b,2150a-b of the extents 216a-b,2160a-b
compress against the tapered walls of the annular groove 104,1040
when the static trial 100,1000 is engaged by the static trial
holder 200,2000. This taper locking provides for a secure grip so
that the static trial 100,1000 can be manipulated accurately and
efficiently.
[0115] In some embodiments, while not shown in FIGS. 1-6 or FIGS.
7-12 or FIGS. 21-31 or FIGS. 32-44, it is also preferable that the
floor of the annular groove 104,1040 of the cylindrical trunk
106,1060 be ridged (e.g., have ridges that run parallel to the
longitudinal axis of the cylindrical trunk), and the surfaces of
the semicircular extents 216a-b,2160a-b of the static trial holder
200,2000 that compress against the floor of the annular groove
104,1040 when the static trial holder 200,2000 engages the static
trial 100,1000 be correspondingly provided with ridges. The
interlocking of the ridges of the static trial 100,1000 with the
ridges of the static trial holder 200,2000 when the static trial
100,1000 is engaged prevents rotation of the static trial 100,1000
about the longitudinal axis of the cylindrical trunk 106,1060 with
respect to the static trial holder 200,2000.
[0116] In order to more tightly hold the static trial 100,1000 (or
distraction spacer) for manipulation of the static trial 100,1000
(or distraction spacer) during surgical procedures in which greater
forces will be experienced by the static trial 100,1000 (or
distraction spacer) and the static trial holder 200,2000, the
holding enclosure 210,2100 can be placed in a contracted state. The
holding enclosure 210,2100 can be considered "unlocked" in its
receptive or expanded states, and "locked" in its contracted state,
with respect to the nature of the hold that the static trial holder
200,2000 potentially can have or has on the cylindrical trunk
106,1060. Preferably, when the holding enclosure 210,2100 is
locked, a force greater than that which is applicable by an unaided
surgeon or nurse (i.e., that which can be applied to remove the
cylindrical trunk 106,1060 from the holding enclosure 210,2100 when
the holding enclosure 210,2100 is in its receptive state), and
greater than that which will be experienced by the static trial
100,1000 (or distraction spacer) and the static trial holder
200,2000 during surgical procedures) would be required to pull the
cylindrical trunk 106,1060 out of the holding enclosure 210,2100.
The placement of the holding enclosure 210,2100 in its locked state
or unlocked state is effected by operation of a holding assembly
that includes the extension 204,2040 and the sleeve 206,2060 and
the manner in which they are configured and interact.
[0117] More particularly, the prongs 214a-b,2140a-b can be brought
together (or brought closer to one another; it should be understood
that they need not touch to be encompassed by the present
invention), to lock the holding enclosure 210,2100, by a rotation
of the sleeve 206,2060 with respect to the handle 202,2020 and the
extension 204,2040 about the longitudinal axis of the shaft
208,2080. A rotation control knob 219,2190 is provided to ease the
rotation of the sleeve 206,2060. As shown in FIGS. 27 and 29-30 in
view of FIGS. 24-25 and FIGS. 40 and 42-43 in view of FIGS. 35-38,
the bore 218,2180 of the sleeve 206,2060 (shown in cutaway in FIGS.
25 and 38) defines a cross-section that has a width 220,2200 that
is greater than its depth 222,2220. Further as shown in those
figures, the prongs 214a-b,2140a-b when separated (shown in cutaway
in FIGS. 30 and 43) define a cross-section having a width 224,2240
that is greater than its depth 226,2260, the width 224,2240 and
depth 226,2260 of the prongs' cross-section being closely
accommodated by the width 220,2200 and depth 222,2220 of the bore's
cross-section. When the prongs 214a-b,2140a-b are together, the
width of prongs' cross-section is closely accommodated by the depth
222,2220 of the bore's cross-section. Thus, when the sleeve
206,2060 is rotated with respect to the extension 204,2040, the
sides of the bore defining the depth 222,2220 of its cross-section
bear against the sides of the prongs 214a-b,2140a-b defining the
width of their cross-section.
[0118] It should be noted that in order to ease the rotation of the
sleeve 206,2060 so that the side of the bore 218,2180 can bear
against the sides of the prongs 214a-b,2140a-b, the corners of the
bore 218,2180 are radiused, and at least the sides (that face away
from one another) of the prongs 214a-b,2140a-b are curved.
Preferably, as shown, the prongs 214a-b,2140a-b when separated
define a partial cylindrical cross-section. The effect of the
bearing (of the sides of the bore 218,2180 against the sides of the
prongs 214a-b,2140a-b) is borne by the space between the prongs
214a-b,2140a-b, so that the space narrows and the prongs
214a-b,2140a-b are brought toward one another until they are
accommodated within the bore's depth 222,2220. The bringing
together of the prongs 214a-b,2140a-b brings the semicircular
extents 216a-b,2160a-b together to place the holding enclosure
210,2100 into its contracted state, locking it.
[0119] Preferably, with regard to the static trial holder 200, the
sleeve 206 is biased toward establishing the holding enclosure 210
in either an unlocked position or a locked position. Stated
alternatively, when the holding enclosure 210 is unlocked (or
locked), the force required to begin rotation of the sleeve 206 is
greater than the force required to continue rotating the sleeve 206
once rotation has begun. And, as the sleeve 206 is rotated toward a
position that will unlock (or lock), the holding enclosure 210, it
is biased toward stopping its rotation at that upcoming position.
Stated alternatively, as the sleeve 206 is being rotated, the force
required to rotate the sleeve 206 past that upcoming position is
greater than the force that is required to rotate it prior to
reaching that upcoming position.
[0120] This biasing of the sleeve 206 of the static trial holder
200 toward positions that will either unlock or lock the holding
enclosure 210 is effected by the inclusion of at least one spaced
recess 228 on the outer surface of the extension 204, and at least
one radial bore 230 through the wall of the sleeve 206 (preferably
through the rotation control knob 219 as shown), which bores 230
each have secured therein a spring plunger (not shown) (it should
be understood that functionally equivalent devices can also be used
in place of a spring plunger). Preferably, each recess 228 is
associated with a respective cooperating bore 230 and spring
plunger. When a given bore 230 (and spring plunger) is aligned with
its associated recess 228, the sleeve 206 is in a position at which
the holding enclosure 210 is either unlocked or locked. Each of the
spring plungers is biased radially inwardly from the inner surface
of the sleeve 206, and as such presses against the outer surface of
the extension 204 as the sleeve 206 is being rotated. Thus, when a
recess 230 is presented to the spring plunger, it plunges into the
recess 230, stopping the rotation of the sleeve 206. In order to
restart (or continue) rotation of the sleeve 206, the bias of the
spring plunger must be overcome when the restarting (or continuing)
rotational force is applied. In order to lower the overcoming force
required to restart or continue the rotation, the end of the spring
plunger is preferably convexly curvate, and the recess is concavely
curvate. Preferably, four recesses 228 and bores 230 (and spring
plungers) are provided, each pair representing one of four
quarter-turn rotated positions of the sleeve 206. At each position
of the sleeve 206, all four plungers plunge into the recesses 228,
securing the sleeve 206 at that position until a sufficient force
is applied to overcome their plunging bias.
[0121] Preferably, with regard to the alternate static trial holder
2000, the movement of the sleeve 2060 toward positions that will
either unlock or lock the holding enclosure 2100, and the stopping
of the sleeve 2060 at such positions, is effected by the inclusion
of at least one groove 2280 that extends in a 90 degree arc on the
outer surface of the extension 2040, and at least one radial bore
2300 through the wall of the sleeve 2060 (preferably through the
rotation control knob 2190 as shown), which bores 2300 each have
secured therein a dog headed screw (not shown) so that a head of
the screw protrudes into interior of the sleeve (it should be
understood that functionally equivalent devices can also be used in
place of a dog headed screw). Preferably, each groove 2280 is
associated with a respective cooperating bore 2300 and dog headed
screw. When a given bore 2300 (and dog headed screw) is aligned
with an end of its associated groove 2280, the sleeve 2060 is in a
position at which the holding enclosure 2100 is either unlocked or
locked (unlocked when the head of the screw is positioned at one
end of the groove, locked when it is positioned at the other end of
the groove). The head of the dog headed screw protrudes into the
interior of the sleeve and into the groove 2280 and rides therein
as the sleeve 2060 is rotated. When an end of the groove 2280 is
reached by the head of the screw, the head of the screw stops
against the wall of the groove 2280 at the end of the groove 2280,
stopping the rotation of the sleeve 2060, and setting the holding
enclosure 2100 to either the unlocked or locked position. In order
to set the holding enclosure 2100 to the alternative position, the
sleeve 2060 is reverse rotated, causing the head of the screw to
ride in the groove 2280 in the opposite direction toward the other
end of the groove 2280. When the head of the screw reaches the
other end of the groove 2280, the head of the screw stops against
the wall of the groove 2280 at that end of the groove 2280,
stopping the rotation of the sleeve 2060, and setting the holding
enclosure 2100 to the alternative position.
[0122] Further, with regard to the alternate static trial holder
2000, the sleeve 2060 preferably has on its exterior surface at
least one stop protrusion 1380 that is positioned and dimensioned
to extend dorsally or ventrally from the exterior surface when the
holding enclosure is in its "locked" state (see FIGS. 45-50), so
that when the surgeon inserts the static trial 100,1000 into the
intervertebral space, the stop protrusions 1380 prevent the static
trial 100,1000 from being inserted too far into the space (that is,
so that the stop protrusions 1380 hit against the lips of the
adjacent vertebral body endplates before the static trial 100,1000
is inserted too far). It should be understood that stop protrusions
can be applied to the static trial holder 200 without departing
from the scope of the invention.
[0123] Accordingly, the static trials 100,1000 of the invention (or
distraction spacers such as those disclosed in the '127
application) can be held and manipulated with either static trial
holder 200,2000, and from a variety of approach angles. Holding the
handle 202,2020 of the static trial holder 200,2000 in one hand, an
operator can push the cylindrical trunk 106,1060 of the static
trial 100,1000 (or the distraction spacer) against the mouth
213,2130 of the holding enclosure 210,2100 with enough force to
temporarily expand the mouth 213,2130 to a width that will
accommodate the diameter of the cylindrical trunk 106,1060 for
passage through the mouth 213,2130. The radially inward tapering of
the sides of the mouth 213,2130 (the facing ends 215a-b,2150a-b of
the semicircular extents 216a-b,2160a-b of the prongs
214a-b,2140a-b) facilitates this insertion. It should be noted
that, with regard to the alternate static trial holder 2000, as
shown in FIGS. 45-50 with reference to FIGS. 7 and 43, the depth
2260 of the prongs' cross-section is closely accommodated by the
depth of the opening establishing by the width of the annular
groove 1020 of the alternate static trial 1000 and the depths 1340
of the notches in the pair of opposing notches (1320a,d, 1320b,d,
or 1320c,f), and the width 2240 of the prongs' cross-section is
accommodated by the width 1360 of the notches in the pair of
opposing notches (1320a,d, 1320b,d, or 1320c,f), so that the
prongs' cross-section fits into the opposing notches as, and when,
the cylindrical trunk 1060 is surrounded by the semicircular
extents 2160a-b. (That is, that the width 1360 of the notch pair
accommodates the width 2240 of the static trial holder's 2000
prongs' 2140a-b cross-section even when the prongs 2140a-b are
separated to place the holding enclosure 2100 in an expanded state
as described below. This enables the notch pair to accommodate the
width 2240 of the prongs' cross-section as the cylindrical trunk
1060 of the static trial 1000 is being snapped into the holding
enclosure 2100.)
[0124] Once the cylindrical trunk 106,1060 has passed into the
holding enclosure 210,2100, the operator can let go of the static
trial 100,1000 (or distraction spacer) because the prongs
214a-b,2140a-b will be overcome by their bias toward their neutral
state and thus hold the static trial 100,1000 in the holding
enclosure 210,2100 to prevent the static trial 100,1000 from
falling out or slipping out as the static trial holder 200,2000 is
moved with the static trial 100,1000 prior to closing (e.g.,
locking) the holding enclosure 210,2100. (When the static trial
100,1000 (or distraction spacer) is being held in this manner, and
the holding enclosure 210,2100 is unlocked, the static trial
100,1000 can be removed from the holding enclosure 210,2100 by a
pulling of the static trial 100,1000 through the mouth 213,2130 of
the holding enclosure 210,2100 with a force required to again
temporarily overcome the bias of the prongs 214a-b,2140a-b toward
their neutral state, to separate them and make the width of the
mouth 213,2130 accommodate the diameter of the cylindrical trunk
106,1060.)
[0125] With regard to the static trial holder 200, once the
operator is ready to lock the holding enclosure 210, while still
gripping the handle 202 of the static trial holder 200, he rotates
the rotation control knob 219 either clockwise or counterclockwise
to move the sleeve 206 to the next quarter-turn position. If the
rotation control knob 219 is rotated with enough force to cause the
spring plungers in the bores 230 to back out of the recesses 228,
the sleeve 206 will rotate as desired. Once the sleeve 206 has
reached the next quarter-turn position, the spring plungers will
find the recesses 228 associated with that position, and plunge
into the recesses 228 to snap the sleeve 206 into the proper
position. As the sleeve 206 rotates, the sides of the sleeve's
bore's inner surface bear against the curved outer surfaces of the
prongs 214a-b to push the prongs 214a-b together so that they are
accommodated by the depth 222 of the bore 218. When the prongs
214a-b are pressed against one another and held in that closed
position by the maintenance of the sleeve 206 in the new position
(maintained by the spring plungers in the recesses 228), the
semicircular extents 216a-b move toward one another and are
correspondingly maintained together about the cylindrical trunk
106,1060. When the prongs 214a-b are held in this manner, the
cylindrical trunk 106,1060 cannot be removed through the mouth 213
of the now-tighter (e.g., locked) holding enclosure 210 without the
application of forces preferably greater than will be encountered
when inserting and removing the static trial 100,1000 from the
intervertebral space during the surgical procedures. Once the
static trial 100,1000 has been inserted and removed from the
intervertebral space (or the distraction spacer has been inserted
and removed from the intervertebral space after being used to
distract the space), the operator can lock the holding enclosure
210 by rotating the sleeve 206 another quarter turn (in either the
clockwise or the counterclockwise direction). Again, if the
rotation control knob 219 is rotated with enough force to cause the
spring plungers to back out of the recesses 228, the sleeve 206
will rotate as desired. Once the sleeve 206 has reached the next
quarter-turn position, the spring plungers will find the recesses
228 associated with that position, and plunge into the recesses 228
to snap the sleeve 206 into the proper position. As the sleeve 206
rotates, the sides of the sleeve's bore's inner surface move away
from the curved outer surfaces of the prongs 214a-b and allow the
prongs 214a-b to separate (under their own bias toward the neutral
position) as they are accommodated by the width 220 of the bore
218. When the prongs 214a-b are separated and allowed to remain in
that position by the maintenance of the sleeve 206 in the new
position (maintained by the spring plungers in the recesses 228),
the semicircular extents 216a-b are separated from one another and
hold the cylindrical trunk 106,1060 against falling or slipping
out. That is, the cylindrical trunk 106,1060 can be removed by the
operator if the operator applies a sufficient force to widen the
mouth 213 of the holding enclosure 210 enough to let the
cylindrical trunk 106,1060 pass through the mouth 213. Once the
static trial 100,1000 (or distraction spacer) is removed, another
one can be inserted and manipulated if required.
[0126] With regard to the static trial holder 2000, once the
operator is ready to lock the holding enclosure 2100, while still
gripping the handle 2020 of the static trial holder 2000, he
rotates the rotation control knob 2190 clockwise (or
counterclockwise depending on how the grooves 2280 are configured;
that is, they are illustrated as being configured to enable a
locking with a clockwise rotation, and an unlocking with a
subsequent counterclockwise rotation, although other embodiments
can enable a locking with a counterclockwise rotation, and an
unlocking with a clockwise rotation, to accommodate left-handed
persons or right-handed persons or for other reasons) to rotate the
sleeve 2060 ninety degrees to the next position. As the sleeve 2060
rotates, the head of the dog headed screw rides freely in the
groove 2280, and the sides of the sleeve's bore's inner surface
bear against the curved outer surfaces of the prongs 2140a-b to
push the prongs 2140a-b together so that they are accommodated by
the depth 2220 of the bore 2180. As the dog headed screw reaches
the end of the groove 2280, the prongs 2140a-b are pressed against
one another and the semicircular extents 2160a-b move toward one
another. The prongs 2140a-b are held in and biased toward the
closed position, and the semicircular extents 2160a-b are
correspondingly maintained together about the cylindrical trunk
106,1060, by the fitting of the bore's surfaces against the prongs'
surfaces. When the prongs 2140a-b are held in this manner, the
cylindrical trunk 106,1060 cannot be removed through the mouth 2130
of the now-tighter (e.g., locked) holding enclosure 2100 without
the application of forces preferably greater than will be
encountered when inserting and removing the static trial 100,1000
from the intervertebral space during the surgical procedures.
[0127] Further with regard to the static trial holder 2000 engaging
the static trials 1000, the interference between the prongs 2140a-b
and the opposing notches in the notch pair in which the prongs
2140a-b are disposed prevents rotation of the static trial 1000
about a longitudinal axis (e.g., an axis parallel to the
longitudinal axis of the cylindrical trunk 1060) with respect to
the static trial holder 2000. That is, if the static trial 1000 is
encouraged, by forces encountered during manipulation of the static
trial 1000, to rotate about such an axis with respect to the static
trial holder 2000, the side walls of the notches will be confronted
by the prong 2140a-b bodies and such rotational movement of the
static trial 1000 will be stopped. (As can be seen in FIGS. 46-47,
the prongs 2140a-b are too deep to fit into the annular groove 1060
without the notch pair accommodating their depth.) The same will
happen if a reverse rotation about such an axis is attempted.
[0128] Further with regard to the static trial holder 2000, once
the static trial 100,1000 has been inserted and removed from the
intervertebral space (or the distraction spacer has been inserted
and removed from the intervertebral space after being used to
distract the space), the operator can unlock the holding enclosure
2100 by reverse rotating the sleeve 2060 (with enough initial force
to overcome the biasing of the fitting of the bore's and the
prongs' surfaces) ninety degrees. Again, as the sleeve 2060
rotates, the sides of the sleeve's bore's inner surface move away
from the curved outer surfaces of the prongs 2140a-b and allow the
prongs 2140a-b to separate (under their own bias toward the neutral
position) as they are accommodated by the width 2200 of the bore
2180. When the prongs 2140a-b are separated and allowed to remain
in that position by the maintenance of the sleeve 2060 in the new
position (with the head of the dog headed screw against the wall of
the groove 2280 at the other end of the groove 2280), the
semicircular extents 2160a-b are separated from one another and
hold the cylindrical trunk 106,1060 against falling or slipping
out. That is, the cylindrical trunk 106,1060 can be removed by the
operator if the operator applies a sufficient force to widen the
mouth 2130 of the holding enclosure 2100 enough to let the
cylindrical trunk 106,1060 pass through the mouth 2130. Once the
static trial 100,1000 (or distraction spacer) is removed, another
one can be inserted and manipulated if required. As shown in FIGS.
48-50, in addition to the anterior approach angle shown in FIGS.
45-47, the illustrated notch configuration accommodates two
anterior-lateral approach angles as well.
[0129] Accordingly, the static trial holder 200,2000 can be used to
insert and remove the distraction spacers of the '127 application
to distract the intervertebral space as described in the '127, and
thereafter (or during the distraction) hold to insert and remove
the static trials 100,1000 to find the appropriate size of
artificial intervertebral disc to be implanted.
[0130] A preferred embodiment of a dynamic trial of the present
invention will now be described.
[0131] Referring now to FIGS. 51-54, a dynamic trial of the present
invention is shown in top (FIG. 51), side (FIG. 52), side cutaway
(FIG. 53) and perspective (FIG. 54) views.
[0132] The dynamic trial 300 is provided primarily for distracting
an intervertebral space according to the procedures described
herein and/or for determining the appropriate size of an artificial
intervertebral disc to be implanted (or whether a particular size
can be implanted) into the distracted intervertebral space. While
the distraction systems and methods described in the '127
application, as well as the static trials described herein (e.g.,
when used in the manner that the distraction spacers of the '127
application are used), are also useful for distracting an
intervertebral space, the dynamic trial 300 is provided as an
additional or alternate distraction tool. Further, while the static
trials described herein are useful for determining the appropriate
size of an artificial intervertebral disc to be implanted (or
whether a particular size can be implanted), the dynamic trial 300
is provided as an additional or alternate sizing tool.
[0133] More specifically, the dynamic trial 300 includes a shaft
302 having a bifurcated trial 304 at a distal end of the shaft 302.
The trial 304 has an exterior that is preferably formed like the
artificial intervertebral disc that it is meant to approximate.
Accordingly, each half 306a-b of the bifurcated trial 304 has on
its outwardly facing surface a convex dome 308a-b that is shaped
like the convex dome of the corresponding baseplate of the
artificial intervertebral disc that the dynamic trial 300
approximates (e.g., the convex domes 184a-b of the baseplates
168a-b of the artificial intervertebral disc 160 of FIGS. 13-20).
Preferably, each convex dome 308a-b is smooth, rather than having a
porous coating that is preferred for the convex domes 184a-b of the
artificial intervertebral disc 160, and each half 306a-b does not
have stabilizing spikes such as the stabilizing spikes 188a-b on
the outwardly facing surfaces 186a-b of the artificial
intervertebral disc 160. The omission of these device stabilizing
and bone ingrowth encouraging structures and surfaces on the
dynamic trial 300 enables the surgeon to test the size of the
artificial intervertebral disc 160 to be implanted without invading
the vertebral body endplates. The shaft 302 includes an inner shaft
portion 310 that centrally divides at a fulcrum 311 into upper and
lower distal extensions 312a-b. The lower distal extension 312b is
fixed to the upper distal extension 312a at the fulcrum 311,
preferably by screws 313a-b that are plug welded in place.
Preferably, as shown, at least the most proximal screw 313b extends
above the top surface of the upper distal extension 312a to serve
as a backup stop to prevent extreme forward movement of the control
knob 318 that is operated to separate the distal extensions 312a-b
(described below).
[0134] From the point of division to their distal ends, each of the
upper and lower distal extensions 312a-b are spring biased
(preferably by the formation of the fulcrum 311 in combination with
the strength of the material of which the extensions 312a-b are
made, although the use of other types of springs is contemplated by
the present invention) toward positions in which they converge
toward one another (in the figures, the extensions 312a-b are shown
in these positions). The lower distal extension 312b is connected
(preferably fixed as shown) to the lower half 306b of the
bifurcated trial 304, and the upper distal extension 312a is
connected to the upper half 306a of the bifurcated trial 304.
Preferably, as shown, the upper half 306a is adjustably connected
to the upper distal extension 312a by a pivot pin 315 that allows
the upper half 306a to rotate about a lateral axis that passes
through the longitudinal and lateral center of the bifurcated trial
304. This axis of rotation allows the upper half 306a, when
separating from the lower half 306b, to adjust to the orientation
of the upper (adjacent) vertebral bone without causing the bone to
hinge relative to the lower vertebral bone (the bone adjacent the
lower half 306b).
[0135] In order to effect the separation of the upper and lower
halves 306a-b, the shaft 302 further includes an outer shaft potion
314 that is longitudinally translatable adjacent the inner shaft
portion 310. The outer shaft portion 314 preferably straddles the
inner shaft portion 310 as shown, and includes a pin 316 that
passes between the distal extensions 312a-b. The outer shaft
portion 314 is preferably translatable distally by the forward
movement of a control knob 318 near the proximal end of the shaft
302, and translatable proximally by backward movement of the
control knob 318. That is, when the control knob 318 is pushed
distally, the outer shaft portion 314 is moves distally, and
accordingly the pin 316 moves distally. If the pushing force is
great enough to overcome the bias of the divided extensions 312a-b
(their bias toward one another), the divided extensions 312a-b will
separate as the pin 316 moves between them (to make room for the
pin 316). The separation of the extensions 312a-b will
correspondingly separate the halves 306a-b of the bifurcated trial
304. It should be understood that preferably, if the control knob
318 is released, the bias of the divided extensions 312a-b will
press against the pin 316, causing the pin 316 (and correspondingly
the outer shaft portion 314 and the control knob 318) to move
proximally to allow the divided extensions 312a-b to return to
their biased position, which will bring the halves 306a-b of the
trial 304 back together so they can be removed from the
intervertebral space. Preferably, markings 320 are provided on the
inner shaft portion 310 (preferably on its top surface so that the
surgeon can more easily see the markings 320) to quantify the depth
(to which the bifurcated trial 304 is expanded) corresponding to
the distance that the outer shaft portion 314 is translated with
respect to the inner shaft portion 310.
[0136] It is anticipated that the pushing force required to
separate the halves 306a-b will increase as they separate, due to
the compression of the spine seeking to close the intervertebral
space and the annulus seeking to prevent the adjacent vertebral
discs from separating beyond a certain point. Therefore, to provide
a mechanical advantage to the operator in the event that greater
distraction is required, but the operator cannot push the control
knob 318 farther with unaided human effort, an fine control knob
322 is provided. The fine control knob 322 is preferably threaded
onto the proximal end of the inner shaft portion 310, proximal to
the control knob 318. Thus, rotation of the fine control knob 322
about the longitudinal axis of the inner shaft portion 310 will
cause the body of the fine control knob 322 to press against the
control knob 318 to move it farther distally. The interference of
the threads of the fine control knob-inner shaft portion interface
prevents the fine control knob 322 from backing up proximally
unless the fine control knob 322 is reverse rotated to effect that
result.
[0137] Preferably, as shown, the proximal end 324 of the shaft 302
is preferably flanged to serve as a slap hammer for impaction (by
hitting the proximal end 324 with a mallet with a distally directed
force, e.g.), if necessary for proper positioning of the bifurcated
trial 304, and/or forced extraction of the bifurcated trial 304 (by
hitting the flange of the proximal end 324 with a mallet with a
proximally directed force, e.g.).
[0138] Accordingly, the dynamic trial 300 can be used as an
additional or alternative distracting tool (e.g., to the
distraction spacers), and/or as an alternative or additional sizing
tool (e.g., to the static trials). As an example of a use for the
dynamic trial 300 as an alternative or additional distraction tool
and an alterative sizing tool, once the intervertebral space is
distracted to (or, without distraction, is at) a depth that is at
least equal to the depth of the closed bifurcated trial 304, the
bifurcated trial 304 of the dynamic trial 300 can be inserted into
the intervertebral space. (If the intervertebral space must be
distracted initially because it starts out more shallow than the
depth of the closed bifurcated trial 304, the distraction spacers
of the '127 application and the methods disclosed therein can be
used, e.g.) The control knob 318 and/or fine control knob 322 can
be operated to separate the halves 306a-b of the bifurcated trial
304 to distract the space as clinically appropriate. Because the
bifurcated trial 304 is shaped externally to approximate the
artificial intervertebral disc to be implanted (e.g., the
artificial intervertebral disc 160), and because the pivoting of
the upper half 306a of the bifurcated trial 304 allows the halves
306a-b to appropriately lordotically orient themselves, when the
surgeon determines the intervertebral space to be distracted to its
proper dimension (based on how much compression is being
experienced on the dynamic trial 300 and how tight the annulus is),
he can read the markings 320 on the shaft 302 to determine what
size of artificial intervertebral disc 160 is suitable for the
dimensioned intervertebral space. A subsequent bringing together of
the halves 306a-b and a removal of the dynamic trial 300 can then
be followed by insertion of the appropriately sized artificial
intervertebral disc 160 (e.g., in manners described below with
regard to the inserter/impactors).
[0139] As an example of a use for the dynamic trial 300 as an
alternative distraction tool and an additional sizing tool, after
the surgeon has initially distracted the intervertebral space
(preferably with the distraction spacers of the '127 application or
the static trials described herein), and applied one or more of the
static trials 100,1000 to the intervertebral space to determine the
appropriate size of the artificial intervertebral disc to be
implanted (e.g., the artificial intervertebral disc 160), the
surgeon can apply the dynamic trial 300, expand it to the size of
the static trial 100,1000 that was determined to be the appropriate
size for the intervertebral space, and then further open the
dynamic trial 300 for a final sizing. An example of a final sizing
that would be useful would be to test the amount of farther
distraction that is clinically possible, without having to remove
and replace static trials 100,1000 when the compression force of
the spine and the tension force of the annulus are at their higher
levels. Also, the surgeon may wish to distract the space slightly
more than the size of the appropriately sized static trial 100,1000
or artificial intervertebral disc 160, so that the artificial
intervertebral disc 160 can be more easily inserted after removal
of the static 100,1000 or dynamic trial 300 results in a
compressive settling of the intervertebral space. The surgeon may
also wish to distract the space slightly more than the size of the
appropriately sized static trial 100,1000 or artificial
intervertebral disc 160, to prepare it for easy insertion of the
artificial intervertebral disc 160 to be implanted, with
consideration for the height of the stabilizing spikes 188a-b on
the outwardly facing surfaces 186a-b of the baseplates 168a-b of
the artificial intervertebral disc 160. While the artificial
intervertebral disc 160 having the spikes 188a-b can be implanted
without the additional distraction, some surgeons may find such
additional distraction useful or desirable for a particular
case.
[0140] Preferred embodiments of inserter/impactors of the present
invention will now be described.
[0141] Referring now to FIGS. 55-58, an inserter/impactor of the
present invention is shown in side (FIG. 55), top (FIG. 56), side
cutaway (FIG. 57) and perspective (FIG. 58) views. FIGS. 59-62 show
side (FIG. 59), top (FIG. 60), side cutaway (FIG. 61), and
perspective (FIG. 62) views of an inserter/impactor of the present
invention holding a static trial of the present invention. FIGS.
63-64 show top views of an inserter/impactor of the present
invention holding a static trial of the present invention in two
alternative ways. FIGS. 65-68 show side (FIG. 65), top (FIG. 66),
side cutaway (FIG. 67), and perspective (FIG. 68) views of an
inserter/impactor of the present invention holding an exemplary
artificial intervertebral disc of the present invention. FIGS.
69-70 show top views of an inserter/impactor of the present
invention holding an exemplary artificial intervertebral disc of
the present invention in two alternative ways.
[0142] Referring now to FIGS. 71-82 side (FIG. 71), perspective
(FIG. 72), and close-up perspective (FIG. 73) views of a wedge
plate inserter/impactor of the present invention. FIGS. 74-77 show
bottom (FIG. 74), side (FIG. 75), top (FIG. 76), and side cutaway
(FIG. 77) views of a distal end of a wedge plate inserter/impactor
of the present invention. FIGS. 78-79 show top (FIG. 78) and side
(FIG. 79) views of a wedge plate inserter/impactor of the present
invention holding an exemplary artificial intervertebral disc.
FIGS. 80-82 show top (FIG. 80), side (FIG. 81), and side cutaway
(FIG. 82) views of a distal end of a wedge plate inserter/impactor
of the present invention holding an exemplary artificial
intervertebral disc.
[0143] Each inserter/impactor 400,4000 is provided primarily for
holding, inserting, repositioning, removing, impacting, extracting,
and otherwise manipulating an artificial intervertebral disc having
features suitable for being manipulated by the inserter/impactor.
(However, they can also be used to hold, insert, reposition,
remove, impact, extract, and otherwise manipulate the static trials
100,1000 as described above, as well as any other orthopedic device
having suitable features therefor. For example, it should be
understood that distraction of an intervertebral space can be
accomplished in conjunction with a cooperating tool or spacer that
can be gripped by the inserter/impactor.) Exemplary suitable
artificial intervertebral discs include, but are not limited to,
the artificial intervertebral disc 160 described herein and the
artificial intervertebral discs described in the '032 and '327
patents with regard to FIGS. 8a-z, 9a-u, 10a-u, 11a-k, and 12a-p
thereof and by the accompanying descriptions therefor (e.g.,
embodiments identified as the first, second, third, fourth, and
fifth preferred embodiments of the fourth embodiment family, etc.).
Regarding the features suitable for being manipulated by the
inserter/impactor 400,4000, such features include those discussed
above as being suitable features on the static trials 100,1000 and
disc 160, namely, an anteriorly facing flat surface on the second
(e.g., lower) baseplate of the trial or disc, flanked by two
anteriolaterally facing flat surfaces (one on each side of the
anteriorly facing flat surface), and, to provide for holding of the
trial or disc for an anterior insertion approach, a hole spaced
from the anteriorly facing flat surface, the hole having a
longitudinal axis parallel to the anteriorly facing flat surface.
Further regarding the features suitable for being manipulated by
the wedge plate inserter/impactor 4000, such features further
include the inwardly facing surfaces of the baseplates of the trial
or disc.
[0144] More particularly, the inserter/impactor 400,4000 includes a
shaft 402,4020 having a distal end 404,4040 that has angled flat
surfaces 420a-c,4200a-f corresponding to and fittable against
angled flat surfaces of the static trial (e.g., the surfaces
120a-f,1200a-f of the static trial 100,1000) or artificial
intervertebral disc (e.g., the surfaces 180a-f of the artificial
intervertebral disc 160) to be implanted. For example, in an
anterior approach for the trial 100,1000 (as shown in FIGS. 59-62
as an example of how either static trial 100,10000 can be engaged
by either inserter/impactor 400,4000), 120a,1200a and 120d,1200d
facing 420a (or 4200a and 4200d), 120b,1200b and 120e,1200e facing
420b (or 4200b and 4200e), and 120c,1200c and 120f,1200f facing
420c (or 4200c and 42000, and in an anterior approach for the disc
160 (as shown in FIGS. 65-68 as an example of how the disc 160 can
be engaged by either inserter/impactor 400,4000), 180a and 180d
facing 420a (or 4200a and 4200d), 180b and 180e facing 420b (or
4200b and 4200e), and 180c and 180f facing 420c (4200c and 4200f).
Additionally with regard to the wedge plate inserter/impactor 4000,
the distal end 4040 has a wedge-shaped extension 4042 including
upper 4200g and lower 4200h wedge surfaces corresponding to and
fittable against the inwardly facing surfaces of the artificial
intervertebral disc (e.g., the lower surface 164a of the upper
baseplate 168a of the disc 160, and the upper surface 164b of the
lower baseplate 168b of the disc 160, respectively) to be
implanted, causing the baseplates to be angled at a 15 degree
lordosis angle, with the lower surface 164a of the upper baseplate
168a held against the upper surface 4200g, and the upper surface of
the shield being held against the lower surface 4200h, as best
shown in FIGS. 78-82.
[0145] In particular with regard to the wedge plate
inserter/impactor 4000, the inserter/impactor 4000 holds the disc
160 in a preferred position with respect to the inserter/impactor
4000. (It should be understood that the surfaces of the
wedge-shaped extension 4042 can be modified within the scope of the
present invention to hold the disc 160 (or another orthopedic
device) at positions other than those illustrated herein.) In the
illustrated embodiment of the inserter/impactor 4000 in use with
the disc 160, the preferred position is with the baseplates 168a,b
of the disc 160 angle at 15 degrees of lordosis with respect to one
another. More particularly, as best shown in FIGS. 78-82,
preferably, the upper and lower surfaces (e.g., 4200g and 4200h) of
the wedge-shaped extension 4042 protrude from the distal end 4040
and are formed to hold the baseplates 168a,b such that they are
angled at 15 degrees of lordosis with respect to one another. A
surface (e.g., lower surface 4200h) of the wedge-shape extension
4042 that mates with an inwardly facing surface of a baseplate
(e.g., the lower baseplate 168b) of a disc (e.g., 160) may be
correspondingly shaped (e.g., curved or flat) for interaction or
mating with the disc baseplate (e.g., the lower surface 4200h of
the wedge-shaped extension as illustrated is curved to accommodate
the surface of the shield of the disc). Preferably, the forward
surface 4200i of the wedge-shaped extension 4042 has a concave
curvature towards the shaft 4020 of the inserter/impactor 4000,
also for accommodating the curvature of the surface of the shield
of the disc.
[0146] Also preferably with regard to the wedge plate
inserter/impactor 4000 and this preferred positioning, the wedge
surfaces of the distal end 4040 protrude from a distance midway
with respect to the top and bottom of the distal end 4040 and span
(e.g., right to left or vice-versa) the entire distal face of the
distal end 4040, and the surfaces 4200d-f above the wedge on the
distal end 4040 are respectively perpendicular to the wedge's upper
surface 4200g such that each is disposed in parallel with its
respective corresponding surface of the disc 160 when the disc 160
is held by the inserter/impactor 4000 at the appropriate lordosis
angle. (And, accordingly, are angled approximately 15 degrees with
respect to the surfaces below the wedge 4200a-c.) Preferably, for
an anterior approach, the wedge-shaped extension 4042 is designed
and shaped to fit with its antero-lateral confronting surfaces
(4200d,f and 4200a,c) tightly against the correspondingly
antero-laterally facing surfaces (180d,f and 180a,c) of the disc
160, but such that its anterior confronting surfaces (4200e and
4200b) are slightly spaced from the anteriorly facing surfaces
(180d and 180b) of the disc 160, when the disc is held by the
inserter/impactor 4000. This is primarily to address manufacturing
issues (in some instances, tolerances may not be adequately defined
to ensure that all of those surfaces fit tightly against their
corresponding surfaces), so that if there are manufacturing
anomalies, any slight tolerance differences that may exist are
nevertheless still adequate to ensure at least the tight fitting of
the antero-lateral confronting surfaces, so that manipulation of
the disc 160 is possible (e.g., in the manner of a wrench against
an angled nut). This can be achieved, e.g., by designing the
anterior confronting surfaces (4200e and 4200b) to each be slightly
greater in length than the corresponding anteriorly facing surfaces
(180e and 180b) of the disc baseplates, while still being angled
with respect to the antero-lateral confronting surfaces (4200d,f
and 4200a,c) at the same angle the antero-laterally facing surfaces
(180d,f and 180a,c) of the disc baseplates are angled with respect
to the anteriorly facing surfaces (180e and 180b) of the disc. The
increased length of the anterior confronting surfaces on the wedge
extension results in the slight clearance between the anteriorly
facing surfaces (180e and 180b) of the disc and the corresponding
anterior confronting surface (4200e and 4200b) of the wedged distal
end, thereby ensuring that the disc will be fully seated against
the antero-lateral confronting surfaces of the distal end despite
possible manufacturing, material or other inevitable variations in
tolerances of the artificial intervertebral disc or the
inserter/impactor. As noted above, similar in this regard to the
manner in which a wrench engages a nut, this fitting increases the
mechanical advantage toward repositioning the disc in the
intervertebral space. It should be noted, inasmuch as the
inserter/impactor 4000 described herein can engage the disc from
the antero-lateral angles as well, the anterior confronting
surfaces (4200e and 4200b) should also be longer than the
antero-laterally facing surfaces (180d,f and 180a,c) of the disc,
so that a similar fitting occurs when the disc is held from the
antero-lateral angles. Stated broadly, the primary confronting
surfaces (e.g., the anterior confronting surfaces) of the
inserter/impactor are preferably slightly longer than the primary
confronted surfaces (e.g., anteriorly facing surfaces) of the disc
for any given holding orientation.
[0147] Each inserter/impactor 400,4000 includes a holding pin
408,4080 that extends from the center flat surface 420b,4200b along
a longitudinal axis of the shaft 402,4020, the pin 408,4080 having
a distal end 410,4100 that is bent downwardly. The holding pin
408,4080 is spring loaded (by a spring 409,4090) in a central
channel of the shaft 402,4020, so that it is biased toward and
against the shaft 402,4020 (preferably, the bent end 410,4100 of
the pin 408,4080 prevents it from entering the central channel).
With regard to the wedge plate inserter/impactor 4000, the holding
pin 4080 is restricted from upwardly lateral movement with respect
to the distal end of the inserter/impactor 4000 by the presence of
the wedge-shaped extension 4042 of the distal end 4040 of the
inserter/impactor 4000. More particularly, with any attempted
upward movement of the holding pin 4080, the pin encounters the
upper surface of the channel in which the pin 4080 travels,
preventing any such upward movement. On both inserter/impactors
400,4000, the holding pin 408,4080 is preferably heat treated
(e.g., cold formed) to increase material quality (e.g.,
strength).
[0148] A flange 411,4160, mechanically connected to the pin
408,4080 and translating adjacent the shaft 402,4020, can be pushed
distally to overcome the bias of the spring 409,4090 to space the
pin 408,4080 away from the central flat surface 420b,4200b. (An
alternative configuration is one in which the flange 411,4160 and
the pin 408,4080 are formed from a single piece, rather than being
mechanically connected.) In this extended position, the pin
408,4080 can be inserted in the hole 122b,1220b,182b in the
baseplate 108b,1080b,168b of the static trial 100,1000 or
artificial intervertebral disc 160. Releasing the flange 411,4160
allows the spring 409,4090 to pull the pin 408,4080 back, causing
the anteriorly facing surface 120b,1200b,180b of the baseplate
108b,1080b,168b to be held against the central flat surface 420b of
the inserter/impactor 400 (or against the lower central flat
surface 4200b of the inserter/impactor 4000) and the
anterioloaterally facing flat surfaces 120a,c,1200a,c,180a,c of the
static trial 100,1000 or artificial intervertebral disc 160 to be
held against the other corresponding flat surfaces 420a,c of the
inserter/impactor 400 (or against the other corresponding flat
surfaces 4200a,c of the inserter/impactor 4000). Further and
simultaneously, with regard to the wedge plate inserter/impactor
4000, the anteriorly facing surface 180e of the baseplate 168a is
pulled against the upper central flat surface 4200e of the
inserter/impactor 4000 and the anterioloaterally facing flat
surfaces 180d,f of the artificial intervertebral disc 160 is pulled
against the other corresponding flat surfaces 4200d,f of the
inserter/impactor 4000. Additionally with regard to the wedge plate
inserter/impactor 4000, as noted above, the upper and lower wedge
surfaces (4200g,h) interfere between the inwardly facing surfaces
164a,b of the disc baseplates, causing the baseplates to be angled
at a 15 degree lordosis angle, with the lower surface 164a of the
upper baseplate 168a held against the upper surface 4200g, and the
upper surface of the shield being held against the lower surface
4200h, as best shown in FIGS. 78-82.
[0149] A knob 412,4120, threaded on the shaft 402,4020, can be
rotated about the longitudinal axis of the shaft 402,4020 to push
the flange 411,4160 farther proximally, to pull the pin 409,4090
tighter and therefore lock its position (the interference of the
threads of the knob-shaft interface prevents the knob 412,4120 from
moving distally unless the knob 412,4120 is reverse rotated to
effect that result) to more securely hold the baseplate
108b,1080b,168b, and reverse rotated to unlock and loosen the pin
409,4090.
[0150] When the static trial 100,1000 or disc 160 is held in this
manner, rotation of the static trial 100,1000 or disc 160 about a
longitudinal axis (of the static trial 100,1000 or disc 160)
relative to the inserter/impactor 400,4000 is prevented by
interference of the corners of the static trial's 100,1000 or
disc's 160 flat surfaces 120a-c,1200a-c,180a-c and the corners of
the inserter/impactor's 400,4000 flat surfaces 420a-c,4200a-f,
similar to the manner in which a wrench holding a nut prevents
rotation of the nut relative to the wrench. Further, the holding of
the static trial 100,1000 or disc 160 in this manner allows for
some repositioning of the static trial 100,1000 or disc 160 in the
intervertebral space via rotation of the static trial 100,1000 or
disc 160 in either direction about the longitudinal axis of the
intervertebral space.
[0151] Further, with regard to the wedge plate inserter/impactor
4000, when the static trial 100,1000 or disc 160 is held in this
manner, rotation of the static trial 100,1000 or disc 160 about a
lateral axis (of the static trial 100,1000 or disc 160) relative to
the inserter/impactor 4000 is prevented by interference of the
inwardly facing surface (e.g., 164a) of the first baseplate (e.g.,
upper baseplate) of the static trial 100,1000 or disc 160 and the
upper surface 4200g of the wedge on the distal end 4040, and by
interference of the inwardly facing surface (e.g., 164b) of the
second baseplate (e.g., lower baseplate) of the static trial
100,1000 or disc 160 and the lower surface 4200h of the wedge on
the distal end 4040. Accordingly, the holding of the static trial
100,1000 or disc 160 in this manner allows for some repositioning
of the static trial 100,1000 or disc 160 in the intervertebral
space via rotation of the static trial 100,1000 or disc 160 in
either direction about the longitudinal or latitudinal axis of the
intervertebral space.
[0152] In some embodiments of the wedge plate inserter/impactor
4000, when the artificial intervertebral disc 160 is held by the
inserter/impactor 4000, the flat surfaces 180a-c are more closely
confronted by the angled flat surfaces 4200a-c of the
inserter/impactor 4000, compared with the flat surfaces 180d-f
being less closely confronted by the angled flat surfaces 4200d-f
of the inserter/impactor 4000. As such, the structure of the
artificial intervertebral disc 160 having the flat surfaces 180d-f
(e.g., the upper baseplate 168a) has slightly more rotation and
angulation freedom relative to the inserter/impactor 4000 when
being held, compared to the structure of the artificial
intervertebral disc 160 having the flat surfaces 180a-c (e.g., the
lower baseplate 168b). This permits the artificial intervertebral
disc 160 to adjust to the intervertebral space (e.g., to the
angulation of the adjacent vertebral endplates, defining the
intervertebral space, relative to one another) as it is being
inserted thereinto. That is, typically, the adjacent vertebral
endplates will be lordotically angled with respect to one another
as a result of the intervertebral space being prepared and
distracted.
[0153] Preferably, both of the baseplates of the static trial
100,1000 or disc 160 have similarly configured flat surfaces. For
example, the lower baseplate's 108b,1080b,168b flat surfaces
120a-c,1200a-c,180a-c have similarly configured and similarly
oriented counterpart flat surfaces 120d-f,1200d-f,180d-f on the
upper baseplate 108a,1080a,168a. Further preferably, both
baseplates' 108a-b,1080a-b,168a-b flat surfaces
120a-f,1200a-f,180a-f face the angled flat surfaces 420a-c,4200a-f
of the inserter/impactor 400,4000 when the static trial 100,1000 or
disc 160 is held by the inserter/impactor 400,4000. For example, in
an anterior approach for the trial 100,1000 (as shown in FIGS.
59-62 as an example of how either trial 100,1000 can be held by
either inserter/impactor 400,4000), 120a,1200a and 120d,1200d
facing 420a (or 4200a and 4200d), 120b,1200b and 120e,1200e facing
420b (or 4200b and 4200e), and 120c,1200c and 120f,1200f facing
420c (or 4200c and 4200f), and in an anterior approach for the disc
160 (as shown in FIGS. 65-68), 180a and 180d facing 420a (or 4200a
and 4200d), 180b and 180e facing 420b (or 4200b and 4200e), and
180c and 180f facing 420c (or 4200c and 4200f).
[0154] It should be noted that preferably, when the static trial
100,1000 is held by the inserter/impactor 400,4000, the flat
surfaces 120a-c,1200a-c and the counterpart flat surfaces
120d-f,1200d-f are tightly held against the angled flat surfaces
420a-c,4200a-f of the inserter/impactor 400,4000 as described
above. It is also preferable that the baseplates 108a-b,1080a-b of
each of the plurality of static trials 100,1000 be appropriately
lordotically angled relative to one another to ease insertion of
the static trial 100,1000 into the intervertebral space and to
mimic how the artificial intervertebral disc 160 will typically be
oriented as it is being inserted using the inserter/impactor
400,4000. While not shown in FIGS. 1-6 or FIGS. 7-12, in some
embodiments, when the static trials 100,1000 are formed in such a
lordotically oriented configuration, it is preferable that the flat
surfaces 120d-f,1200d-f on the first (e.g., upper) baseplate
108a,1080a be parallel to the flat surfaces 120a-c,1200a-c of the
second (e.g., lower) baseplate 108b,1080b in the static trial's
100,1000 appropriately lordotically oriented configuration, so that
when the static trial 100,1000 is held tightly by the
inserter/impactor 400,4000, the flat surfaces 120a-f,1200a-f are
flush with the flat surfaces 420a-c,4200a-f of the
inserter/impactor 400,4000 even though the baseplates
108a-b,1080a-b are lordotically oriented configuration, it is
preferable that the flat surfaces 120d-f,1200d-f on the first
(e.g., upper) baseplate 108a,1080a be parallel to the flat surfaces
120a-c,1200a-c of the second (e.g., lower) baseplate 108b,1080b in
the static trial's 100,1000 appropriately lordotically oriented
configuration, so that when the static trial 100,1000 is held
tightly by the inserter/impactor 400,4000, the flat surfaces
120a-f,1200a-f are flush with the flat surfaces 420a-c,4200a-f of
the inserter/impactor 400,4000 even though the baseplates
108a-b,1080a-b are lordotically angled with respect to one
another.
[0155] With regard to the inserter/impactor 400, by contrast,
preferably, when the artificial intervertebral disc 160 is held by
the inserter/impactor 400, the flat surfaces 180a-c are tightly
held against the angled flat surfaces 420a-c of the
inserter/impactor 400 as described above, but the counterpart flat
surfaces 180d-f are loosely held against the angled flat surfaces
420a-c of the inserter/impactor 400. As such, the structure of the
artificial intervertebral disc 160 having the counterpart flat
surfaces 180d-f (e.g., the upper baseplate 168a) is able to
angulate and rotate to a limited extent relative to the structure
of the artificial intervertebral disc 160 having the flat surfaces
180a-c. This permits the artificial intervertebral disc 160 to
adjust to the intervertebral space (e.g., to the angulation of the
adjacent vertebral endplates, defining the intervertebral space,
relative to one another) as it is being inserted thereinto. That
is, typically, the adjacent vertebral endplates will be
lordotically angled with respect to one another as a result of the
intervertebral space being prepared and distracted. As the
artificial intervertebral disc 160 is then inserted into the
intervertebral space using the inserter/impactor 400, then, the
baseplates 168a-b will be permitted to lordotically angle with
respect to one another to squeeze into the intervertebral
space.
[0156] With regard to the wedge plate inserter/impactor 4000, when
the artificial intervertebral disc 160 is held by the
inserter/impactor 4000, the wedge surfaces of the distal end 4040
protrude from a distance midway with respect to the top and bottom
of the distal end 4040 and span (e.g., right to left or vice-versa)
the entire distal face of the distal end 4040, and the surfaces
4200d-f above the wedge on the distal end 4040 are respectively
perpendicular to the wedge's upper surface 4200g such that each is
disposed in parallel with its respective corresponding surface of
the disc 160 when the disc 160 is held by the inserter/impactor
4000 at the appropriate lordosis angle. (And, accordingly, are
angled approximately 15 degrees with respect to the surfaces below
the wedge 4200a-c.) Preferably, for an anterior approach, the
wedge-shaped extension 4042 is designed and shaped to fit with its
antero-lateral confronting surfaces (4200d,f and 4200a,c) tightly
against the correspondingly antero-laterally facing surfaces
(180d,f and 180a,c) of the disc 160, but such that its anterior
confronting surfaces (4200e and 4200b) are slightly spaced from the
anteriorly facing surfaces (180d and 180b) of the disc 160, when
the disc is held by the inserter/impactor 4000. This is primarily
to address manufacturing issues (in some instances, tolerances may
not be adequately defined to ensure that all of those surfaces fit
tightly against their corresponding surfaces), so that if there are
manufacturing anomalies, any slight tolerance differences that may
exist are nevertheless still adequate to ensure at least the tight
fitting of the antero-lateral confronting surfaces, so that
manipulation of the disc 160 is possible (e.g., in the manner of a
wrench against an angled nut). This can be achieved, e.g., by
designing the anterior confronting surfaces (4200e and 4200b) to
each be slightly greater in length than the corresponding
anteriorly facing surfaces (180e and 180b) of the disc baseplates,
while still being angled with respect to the antero-lateral
confronting surfaces (4200d,f and 4200a,c) at the same angle the
antero-laterally facing surfaces (180d,f and 180a,c) of the disc
baseplates are angled with respect to the anteriorly facing
surfaces (180e and 180b) of the disc. The increased length of the
anterior confronting surfaces on the wedge extension results in the
slight clearance between the anteriorly facing surfaces (180e and
180b) of the disc and the corresponding anterior confronting
surface (4200e and 4200b) of the wedged distal end, thereby
ensuring that the disc will be fully seated against the
antero-lateral confronting surfaces of the distal end despite
possible manufacturing, material or other inevitable variations in
tolerances of the artificial intervertebral disc or the
inserter/impactor. As noted above, similar in this regard to the
manner in which a wrench engages a nut, this fitting increases the
mechanical advantage toward repositioning the disc in the
intervertebral space. It should be noted, inasmuch as the
inserter/impactor 4000 described herein can engage the disc from
the antero-lateral angles as well, the anterior confronting
surfaces (4200e and 4200b) should also be longer than the
antero-laterally facing surfaces (180d,f and 180a,c) of the disc,
so that a similar fitting occurs when the disc is held from the
antero-lateral angles. Stated broadly, the primary confronting
surfaces (e.g., the anterior confronting surfaces) of the
inserter/impactor are preferably slightly longer than the primary
confronted surfaces (e.g., anteriorly facing surfaces) of the disc
for any given holding orientation.
[0157] Also preferably, in order to provide for a holding of the
static trial 100,1000 or disc 160 for two additional (here,
anteriolateral) insertion approaches, each static trial 100,1000 or
disc 160 also includes two additional holes 122a,1220a,182a and
122c,1220c,182c, one (e.g., 122a,1220a,182a) spaced apart from one
of the anteriolaterally facing flat surfaces (e.g.,
120a,1200a,180a), and the other (e.g., 122c,1220c,182c) spaced
apart from the other of the anteriolaterally facing flat surfaces
(e.g., 120c,1200c,180c). Accordingly, operation of the
inserter/impactor 400,4000 can fit the holding pin 408,4080 into
either of these two additional holes 122a,1220a,182a or
122c,1220c,182c, and hold the associated anteriolaterally facing
flat surface (the one associated with the hole into which the pin
408,4080 is fit) of the static trial 100,1000 or disc 160 against
the flat surface of the inserter/impactor 400,4000 opposite the pin
408,4080. For example, in a first anteriolateral approach for the
trial 100,1000 (as shown in FIG. 63 as an example of how either
trial 100,1000 can be engaged by either inserter/impactor
400,4000), 120a,1200a and 120d,1200d not confronted, 120b,1200b and
120e,1200e facing 420a (or 4200a and 4200d), and 120c,1200c and
120f,1200f facing 420b (or 4200b and 4200e), and a first
anteriolateral approach for the disc 160 (as shown in FIG. 69 as an
example of the how the disc 160 can be engaged by either
inserter/impactor 400,4000), 180a and 180d not confronted, 180b and
180e facing 420a (or 4200a and 4200d), and 180c and 180f facing
420b (or 4200b and 4200e). And, for example, in a second
anteriolateral approach for the trial 100 (as shown in FIG. 64 as
an example of how either trial 100,1000 can be engaged by either
inserter/impactor 400,4000), 120a,1200a and 120d,1200d facing 420b
(or 4200b and 4200e), 120b,1200b and 120e,1200e facing 420c (or
4200c and 4200f), and 120c,1200c and 120f,1200f not confronted, and
a second anteriolateral approach for the disc 160 (as shown in FIG.
70 as an example of how the disc 160 can be engaged by either
inserter/impactor 400,4000), 180a and 180d facing 420b (or 4200b
and 4200e), 180b and 180e facing 420c (or 4200c and 4200f), and
180c and 180f not confronted.
[0158] It should be understood that preferably, in order to
facilitate these additional approaches, the angle separating the
anteriorly facing flat surface of the static trial 100,1000 or disc
160 and one of the anteriolaterally facing flat surfaces of the
static trial 100,1000 or disc 160 is equal to the angle separating
the anteriorly facing flat surface and the other of the
anteriolaterally facing flat surfaces. Preferably, the surfaces are
angled with respect to one another at an angle of 33.4 degrees.
[0159] It should also be understood that the inclusion of
additional adjacent angulated surfaces (or placing the angulated
surfaces in other locations on the trial or disc or other
orthopedic device), and/or including corresponding holes adjacent
to such surfaces, can provide the surgeon with additional
approaches, e.g., other anteriolateral approaches, directly lateral
approaches, posteriolateral approaches, and/or directly posterior
approaches. For example, a trial or disc can have angled surfaces
(and corresponding holes) along the entire perimeter of one or both
of the baseplates, and thus enable the surgeon to engage the trial
or disc from a number of angles, including anterior, posterior,
lateral, anteriolateral, and posteriolateral angles.
[0160] The inserter/impactor 400,4000 further includes at a
proximal end a cap 414,4140 for use as an impact surface if the
trial 100,1000 or disc 160 must be impacted further into the
intervertebral space after insertion, or forcibly extracted from
the intervertebral space. A mallet can be used to strike the cap
414,4140 (in a distal direction for impaction, or in a proximal
direction (using the flange of the cap 414,4140) for extraction).
It should be noted a striking of the cap 414,4140 will translate
the striking force to the baseplates through the shaft 402,4020 and
the flat surfaces, but will not damage the holding pin 408,4080
because the holding pin 408,4080 is spring loaded in the central
channel and thus buffered from the striking force thereby. The
distal end 404,4040 of the inserter/impactor 400,4000 further
preferably includes at least one vertebral body stop (e.g., 4202)
that protrudes longitudinally with respect to the shaft 402,4020,
from the surfaces of the distal end. The stops help prevent the
inserter/impactor from being used to insert the disc (or other
orthopedic device) too far into the intervertebral space.
[0161] Accordingly, the inserter/impactor 400,4000 can be used to
grip either the static trials or the artificial intervertebral disc
to be implanted, and hold the same during insertion and/or removal
of the same, and is useful for a variety of surgical approach
angles.
[0162] Preferred embodiments of a repositioner/extractor of the
present invention will now be described.
[0163] Referring now to FIGS. 83-85, a symmetric
repositioner/extractor of the present invention is shown in side
(FIG. 83), top (FIG. 84), and perspective (FIG. 85) views. And
referring now to FIGS. 86-88, an offset left repositioner/extractor
of the present invention is shown in side (FIG. 86), top (FIG. 87),
and perspective (FIG. 88) views. And referring now to FIGS. 89-91,
an offset right repositioner/extractor of the present invention is
shown in side (FIG. 89), top (FIG. 90), and perspective (FIG. 91)
views. And referring now to FIG. 92-94, an alternative offset left
repositioner/extractor of the present invention is shown in side
(FIG. 92), top (FIG. 93), and perspective (FIG. 94) views. And
referring now to FIGS. 95-97, an alternative offset right
repositioner/extractor of the present invention is shown in side
(FIG. 95), top (FIG. 96), and perspective (FIG. 97) views.
[0164] Each repositioner/extractor is provided primarily for
repositioning and/or extracting a static trial or artificial
intervertebral disc having features suitable for being manipulated
by the repositioner/extractor. Exemplary suitable artificial
intervertebral discs are described in the '032 and '327 patents
with regard to FIGS. 8a-z, 9a-u, 10a-u, 11a-k, and 12a-p thereof
and by the accompanying descriptions therefor (e.g., embodiments
identified as the first, second, third, fourth, and fifth preferred
embodiments of the fourth embodiment family, etc.). Regarding the
features suitable for being manipulated by each
repositioner/extractor, such features include at least two holes
extending longitudinally into one of the baseplates of the static
trial or artificial intervertebral disc from the inwardly facing
surface of the baseplate. More than two holes can be used to
provide for multiple repositioning/extracting approaches.
Preferably, in order for the same repositioning/extracting tool to
be used for multiple approaches on the same trial or artificial
intervertebral disc, adjacent holes should be separated by the same
distance separating other adjacent holes.
[0165] In order to engage the two holes, each
repositioner/extractor has two pins extending in parallel from a
central shaft, perpendicular to the longitudinal axis of the
central shaft. The pins are spaced to engage the two holes
simultaneously, and each pin has a diameter smaller than the
diameter of the hole it is to engage. Therefore, the pins can be
inserted into the holes, and pulling or pushing on the central
shaft along its longitudinal axis when the holes are engaged pulls
or pushes the static trial or artificial intervertebral disc in the
intervertebral space. Further, because two holes are engaged, the
static trial or artificial intervertebral disc can be rotated in
either direction about a longitudinal axis passing through the
intervertebral space, by rotating of the central shaft of the
repositioner/extractor about its distal end, about an axis parallel
to the longitudinal axes of the pins. A handle at a proximal end of
the central shaft is useful for pushing or pulling on the shaft. A
flange adjacent the proximal end of the shaft is useful for
impaction (either with a distally directed force or a proximally
directed force), if necessary to manipulate the shaft.
[0166] On each repositioner/extractor, the pins are formed on
prongs that extend laterally from the central shaft. The direction
of the prongs, and the location of the pins relative to the central
shaft, determine the angle or angles of surgical approach for which
a particular repositioner/extractor can be used. Further, the
number and location of holes further determine the angle or angles
of surgical approach for which a particular repositioner/extractor
can be used. Accordingly, the present invention contemplates a
variety of repositioner/extractors, and a variety of holes
configurations, to provide the surgeon with a variety of possible
surgical approach angles.
[0167] For example, three repositioner/extractors are illustrated,
and, for example, two hole configurations are illustrated.
[0168] The first, symmetric, repositioner/extractor 500, shown in
FIGS. 83-85, includes a shaft 502 having a distal end that is
symmetrically divided into two prongs 504a-b, each of the prongs
having a pin 506a-b extending upwardly and parallel to the pin on
the other prong. The second and third, left offset and right
offset, repositioners/extractors 510,520, shown in FIGS. 86-88 and
89-91, respectively, each include a shaft 512,522 having a distal
end that bends diagonally laterally, the left offset distal end 514
bending in one direction (e.g., to the left), the right offset
distal end 524 bending in an opposite direction (e.g., to the
right). The distal end of each of the second and third
repositioners/extractors 510,520 has two pins 516a-b,526a-b
serially spaced on the bent portion, and each of the pins extends
upwardly and parallel to the other pin. (As shown in FIGS. 92-94
and 95-97, alternative embodiments 530,540 of the second and third,
left offset and right offset, repositioners/extractors each include
a shaft 532,542 having a distal end that has a straight prong
534a,544a and a curved lateral prong 534b,544b, where the curved
lateral prong 534b extends in one direction (e.g., left) for the
alternative left offset repositioner/extractor 530, and where the
curved lateral prong 544b extends in an opposite direction (e.g.,
right) for the alternative right offset repositioner/extractor 540.
Each of the prongs 534a-b,544a-b has a pin 536a-b,546a-b extending
upwardly and parallel to the pin on the other prong. The
alternative repositioners/extractors 530,540, each having a space
between the pins 536a,b,546a,b, provides for avoidance of any
structures on the static trial or artificial intervertebral disc
that may be present between the holes.) On each of the
repositioners/extractors 500,510,520,530,540, the pins are spaced
so that they simultaneously each fit into a respective one of the
two adjacent holes in the baseplate of the static trial or
artificial intervertebral disc. Each of the
repositioners/extractors 500,510,520,530,540 has a handle
508,518,528,538,548 at a proximal end of the central shaft which is
useful for pushing or pulling on the shaft, and a flange
509,519,529,539,549 adjacent the proximal end of the shaft that is
useful for impaction (either with a distally directed force or a
proximally directed force), if necessary to manipulate the
shaft.
[0169] As noted above, the repositioner/extractor that is
appropriate or desired for a given case depends at least in part on
the configuration of the holes in the baseplates. Two hole
configurations are disclosed, as examples of suitable
configurations, although other configurations are possible and
contemplated by the present invention. A first hole configuration
includes three holes on one of the baseplates, the holes being
configured so that a first hole is located in the
anterior-posterior plane, and the adjacent (second and third) holes
are located in respective opposing anteriolateral planes on either
side of the first hole. This hole configuration is shown in FIGS.
98-103, each of which shows a top cutaway view of the artificial
intervertebral disc of FIGS. 13-20, showing its lower baseplate,
having the first hole configuration, engaged by one of the
repositioners/extractors 500,510,520. Each view of the lower
baseplate shows the first hole 550, the second hole 552, and the
third hole 554 of the first hole configuration.
[0170] A second hole configuration includes four holes on one of
the baseplates, the holes being configured so that first and second
holes straddle the anterior-posterior plane, a third hole is
located so that the third hole and the first hole straddle one of
the opposing anteriolateral planes, and a fourth hole is located so
that the fourth hole and the second hole straddle the other of the
opposing anteriolateral planes. This hole configuration is shown in
FIGS. 104-112, each of which shows a bottom cutaway view of the
artificial intervertebral disc of FIGS. 13-20, showing its upper
baseplate, having the second hole configuration, engaged by one of
the repositioners/extractors 500,510,520. Each view of the upper
baseplate shows the first hole 560, the second hole 562, the third
hole 564, and the fourth hole 566, of the second hole
configuration.
[0171] It should be understood that configurations having more or
fewer holes, and in a variety of locations, are contemplated by the
invention, and the detailed descriptions of only two hole
configurations is not meant to limit the invention to only these
two configurations. Importantly, the invention encompasses using a
hole or any number of holes, bored at any suitable angle, whether
parallel to other holes or not, in any number of locations on a
spacer, a trial or an artificial intervertebral disc (not limited
to locations on the baseplates), for purposes of enabling the
spacer, trial, or disc to be engaged by a manipulation instrument
(not limited to a repositioner/extractor) that engages the hole,
and/or to enable the surgeon to work from a variety of approaches.
For example, as described in more detail below, the first and
second hole configurations described herein, in cooperation with
the repositioner/extractors, provide the surgeon with the ability
to work from a directly anterior approach, as well as several
anteriolateral approaches. It should be understood that additional
hole configurations can enable the surgeon to work from a directly
posterior approach, posteriolateral approaches, directly lateral
approaches, or anteriolateral approaches that are different that
those illustrated. For example, the placement of one or more
suitably spaced holes (or the addition of one or more holes) on the
posterior edge, and/or one or both of the lateral edges of one or
both of the baseplates, would enable the surgeon to use the
repositioner/extractors of the present invention to achieve such
approaches.
[0172] As noted above, and referring now to FIGS. 98-112, it can be
seen that each of the repositioner/extractors can be used in more
than one manner depending on the tool desired and the approach
desired. For example, with reference to FIGS. 98-99, regarding the
first hole configuration (three holes in one of the baseplates),
the symmetric repositioner/extractor 500 can be used in either of
two anteriolateral approaches (see FIGS. 98-99). That is, the
symmetric repositioner/extractor's shaft 502 can be inserted into
the wound from either of the two anteriolateral approaches, and the
pins 506a-b can be inserted into the first 550 and second 552 holes
(for one of the two anteriolateral approaches) (FIG. 98) or the
first 550 and third 552 holes (for the other of the two
anteriolateral approaches) (FIG. 99) of the first hole
configuration.
[0173] Also, for example, with reference to FIGS. 100-103,
regarding the first hole configuration, each of the left offset
repositioner/extractor 510 and the right offset
repositioner/extractor 520 can be used in either a directly
anterior approach (FIGS. 100,102) or a respective anteriolateral
approach (FIGS. 101,103). That is, the right offset
repositioner/extractor's shaft 522 can be inserted into the wound
from a direct anterior approach, and the right offset
repositioner/extractor' s pins 526a-b can then be placed into the
first 550 and second 552 holes of the first hole configuration
(FIG. 100). And, the right offset repositioner/extractor's shaft
522 can be inserted into the wound from an anteriolateral approach,
and the right offset repositioner/extractor's pins 526a-b can then
be placed into the first 550 and third 554 holes of the first hole
configuration (FIG. 101). And, the left offset
repositioner/extractor's shaft 512 can be inserted into the wound
from a direct anterior approach, and the left offset
repositioner/extractor's pins 516a-b can then be placed into the
first 550 and third 554 holes of the first hole configuration (FIG.
102). And, the left offset repositioner/extractor's shaft 512 can
be inserted into the wound from an anteriolateral approach, and the
left offset repositioner/extractor's pins 516a-b can then be placed
into the first 550 and second 552 holes of the first hole
configuration (FIG. 103). It should be noted that the alternate
left offset 530 and alternate right offset 540
repositioners/extractors can also fit into the holes of the first
hole configuration in the same manner as described here with regard
to the left offset 510 and right offset 520
repositioners/extractors.
[0174] Also, for example, with reference to FIGS. 104-112,
regarding the second hole configuration (four holes in one of the
baseplates), the symmetric repositioner/extractor 500 can be used
in a directly anterior approach (FIG. 104), and either of two
anteriolateral approaches (FIGS. 105-106). That is, the symmetric
repositioner/extractor's shaft 502 can be inserted into the wound
from a directly anterior approach, and the pins 506a-b can be
inserted into the first 560 and second 562 holes of the second hole
configuration (FIG. 104). And, the symmetric
repositioner/extractor's shaft 502 can be inserted into the wound
from either of the two anteriolateral approaches, and the pins
506a-b can be inserted into the first 560 and third 564 holes (for
one of the two anteriolateral approaches) (FIG. 105) or the second
562 and fourth 566 holes (for the other of the two anteriolateral
approaches) (FIG. 106) of the second hole configuration.
[0175] Also, for example, with reference to FIGS. 107-112,
regarding the second hole configuration, each of the left offset
repositioner/extractor 510 and the right offset
repositioner/extractor 520 can be used in any of three respective
anteriolateral approaches. That is, the right offset
repositioner/extractor's shaft 522 can be inserted into the wound
from any of its three possible anteriolateral approaches, and the
right offset repositioner/extractor's pins 526a-b can then be
placed into the first 560 and second 562 holes (FIG. 107) (for a
first of the three anteriolateral approaches), the first 560 and
third 564 holes (FIG. 108) (for a second of the three
anteriolateral approaches), or the second 562 and fourth 566 holes
(FIG. 109) (for a third of the three anteriolateral approaches).
And, the left offset repositioner/extractor's shaft 512 can be
inserted into the wound from any of its three possible
anteriolateral approaches, and the left offset
repositioner/extractor's pins 516a-b can then be placed into the
first 560 and second 562 holes (FIG. 110) (for a first of the three
anteriolateral approaches), the first 560 and third 564 holes (FIG.
111) (for a second of the three anteriolateral approaches), or the
second 562 and fourth 566 holes (FIG. 112) (for a third of the
three anteriolateral approaches). It should be noted that the
alternate left offset 530 and alternate right offset 540
repositioners/extractors can also fit into the holes of the second
hole configuration in the same manner as described here with regard
to the left offset 510 and right offset 520
repositioners/extractors.
[0176] It should be noted from the illustrations in FIGS. 98-112
that the anteriolateral approaches are at a variety of angles
relative to the anterior-posterior plane, and further that the
illustrated angles are merely exemplary. That is, the invention
encompasses additional approach angles, in that such additional
approach angles are possible by (as described above) adding or
deleting holes, and/or changing the location of holes, and/or
changing the spacing between holes (in conjunction with changing
the spacing between pins), and/or changing the angle at which the
offset repositioner/extractors' pins are placed relative to one
another and to the shaft of such repositioner/extractors.
[0177] As discussed above, once the pins are established in the two
adjacent holes, manipulating the shaft of the
repositioner/extractor will reposition the static trial or
artificial intervertebral disc in the intervertebral space and/or
extract it from the intervertebral space. The use of more than one
pin (versus one pin) enables the static trial or artificial
intervertebral disc to be rotated in either direction about a
longitudinal axis passing through the intervertebral space.
[0178] A preferred embodiment of a leveler of the present invention
will now be described.
[0179] Referring now to FIGS. 113-117, a leveler of the present
invention is shown in bottom (FIG. 113), side (FIG. 114), front
(FIG. 115), top partial perspective (FIG. 116), and bottom partial
perspective (FIG. 117) views. More particularly, FIG. 116 shows a
top perspective view of the distal end of the leveler, and FIG. 117
shows a bottom perspective view of the distal end of the
leveler.
[0180] The leveler is provided primarily for establishing a
parallel orientation of the baseplates (relative to one another),
and/or securing the purchase of the stabilizing spikes, of an
artificial intervertebral disc having features suitable for being
manipulated by the leveler. Exemplary suitable artificial
intervertebral discs are described in the '032 and '327 patents
with regard to FIGS. 8a-z, 9a-u, 10a-u, 11a-k, and 12a-p thereof
and by the accompanying descriptions therefor (e.g., embodiments
identified as the first, second, third, fourth, and fifth preferred
embodiments of the fourth embodiment family, etc.). Regarding the
features suitable for being manipulated by the leveler, such
features include suitably formed inwardly facing surfaces of the
baseplates of the artificial intervertebral disc.
[0181] More particularly, the leveler 600 includes a shaft 602
having a forked distal end formed by two opposing tongs 604a-b that
are symmetric to one another about a longitudinal axis of the shaft
602. Each of the tongs 604a-b has an extent that initially curves
laterally outward away from the shaft 602 and from the other tong's
extent, to define a central pocket 606 forward of the shaft 602
between the tongs' extents. Each tong's extent then resumes a
distal direction to become parallel to the shaft 602 and to the
other tong's extent.
[0182] Each tong's extent has an upper surface 608a-b and a lower
surface 610a-b. The upper surface 608a-b is preferably shaped to
conform against the inwardly facing surface of a first (e.g.,
upper) baseplate of an artificial intervertebral disc, and the
lower surface 610a-b is preferably shaped to conform against the
inwardly facing surface of a second (e.g., lower) baseplate of the
artificial intervertebral disc, so that insertion of the forked
distal end of the leveler 600 between the baseplates, with the
central pocket 606 of the distal end avoiding the central portion
of the artificial intervertebral disc, and with the upper 608a-b
and lower surfaces 610a-b so engaging the inwardly facing surfaces
of the baseplates, causes the baseplates to be placed in parallel
orientation with respect to one another.
[0183] More particularly, for example for use with the exemplary
artificial intervertebral disc of FIGS. 13-20, the upper surface
608a-b of each extent is flat, except for a tapered section 612a-b
at the distal tip of the extent, which tapered section narrows the
tip, and the lower surface 610a-b of each extent is curved to form
opposing concave contours 614a-b that are cooperatingly shaped to
conform against the inwardly facing surface of the convex structure
of the artificial intervertebral disc.
[0184] The preferred use of the leveler 600 is as follows. As
discussed above, once the intervertebral space has been prepared
and distracted to a dimension that will accept the artificial
intervertebral disc to be implanted, the artificial intervertebral
disc 160 is engaged at its lower baseplate 168b by the
inserter/impactor 400,4000 discussed above. During insertion (and,
if necessary, impaction) of the artificial intervertebral disc 160
into the intervertebral space, the upper baseplate 168a remains
free to angulate with respect to the lower baseplate 168b, so that
the angulation of the baseplates conforms to the angulation of the
intervertebral space as the artificial intervertebral disc is being
inserted thereinto. Typically, the endplates of the prepared and
distracted intervertebral space will be lordotically angled with
respect to one another, due to the use of the static trials
100,1000 as described above, which are formed to have a lordotic
taper as discussed above. Thus, when the artificial intervertebral
disc is inserted into the intervertebral space, its baseplates will
be lordotically angled with respect to one another. Once the
artificial intervertebral disc 160 is inserted, the
inserter/impactor 400,4000 can be disengaged, and the
repositioner/extractors 500,510,520,530,540 discussed above can be
applied to the artificial intervertebral disc, if necessary to
achieve a more optimal positioning.
[0185] Once the positioning is established, the leveler 600 is
preferably applied to the artificial intervertebral disc 160. The
forked distal end of the leveler 600 is inserted so that the
extents 604a-b are placed between the inwardly facing surface 164a
of the upper baseplate 168a and the inwardly facing surface 164b of
the convex structure 162 on the lower baseplate 168b, and so that
the central pocket 606 of the leveler 600 avoids the
ball-and-socket joint of the artificial intervertebral disc 160. If
the baseplates are lordotically angled with respect to one another,
the tapered sections 612a-b of the upper surfaces 608a-b of the
forked distal end will be approximately parallel to, and will first
encounter, the angled inwardly facing surface 164a of the upper
baseplate 168a. At the same time, the concave contours 614a-b of
the lower surfaces 610a-b will accommodate the inwardly facing
surface 164b of the convex structure 162 on the lower baseplate
168b. As the tapered sections 612a-b press against the inwardly
facing surface 164a of the upper baseplate 168a, and the concave
contours 614a-b slip into place against the inwardly facing surface
164b of the convex structure 162 on the lower baseplate 168b, the
tapers 612a-b will function as wedges to force the posterior
portion of the upper baseplate 168a away from the posterior portion
of the lower baseplate 168b. Accordingly, as the posterior portions
are being separated, the stabilizing spikes 188a-b on the outwardly
facing surfaces 186a-b of the baseplates 168a-b find or secure
their purchase in the hard bone of the outer ring of the vertebral
body endplates. When the forked distal end is fully seated (stops
616a-b are provided to butt up against the anterior portions of the
baseplates 168a-b to prevent the forked distal end from being
inserted too far), the extents of the tongs 604a-b hold the
baseplates 168a-b parallel to one another, and so that the spikes
188a-b are fully engaged in the endplates. The surgeon then slips
the leveler 600 out from between the baseplates 168a-b, and out
from the wound and completes the procedure. A handle 618 is
provided at a proximal end of the shaft 602 for pushing, pulling,
and otherwise manipulating the leveler 600 as needed.
[0186] Although the invention herein has been described with
reference to particular embodiments, it is to be understood that
these embodiments are merely illustrative of the principles and
applications of the present invention. It is therefore to be
understood that numerous modifications may be made to the
illustrative embodiments and that other arrangements may be devised
without departing from the spirit and scope of the present
invention as defined by the appended claims.
* * * * *