U.S. patent application number 12/467109 was filed with the patent office on 2010-11-18 for spinal marker system and methods of use.
Invention is credited to Daniel Nehls.
Application Number | 20100292693 12/467109 |
Document ID | / |
Family ID | 43069125 |
Filed Date | 2010-11-18 |
United States Patent
Application |
20100292693 |
Kind Code |
A1 |
Nehls; Daniel |
November 18, 2010 |
Spinal Marker System and Methods of Use
Abstract
Temporary, radiographically opaque, bone markers having first
and second penetration members that are concentric with one another
and are configured to pierce bone are provided herein. Bone markers
can non-exclusively be used to help verify the correct surgical
site along the vertebrae, locate the vertical midline, and as a
fixed point for aligning surgical instruments. Insertion and
extraction devices for use with the bone markers are also provided
herein.
Inventors: |
Nehls; Daniel; (Tacoma,
WA) |
Correspondence
Address: |
BAUMGARTNER PATENT LAW
3439 NE Sandy Blvd, Suite 285
PORTLAND
OR
97232
US
|
Family ID: |
43069125 |
Appl. No.: |
12/467109 |
Filed: |
May 15, 2009 |
Current U.S.
Class: |
606/53 |
Current CPC
Class: |
A61B 17/1757
20130101 |
Class at
Publication: |
606/53 |
International
Class: |
A61F 5/56 20060101
A61F005/56 |
Claims
1. A temporary surgical marker comprising: a first penetration
member having an apex configured to pierce bone, and a base that is
concentric and operably coupled to an apex of a second penetration
member configured to pierce bone, wherein the second penetration
member comprises a larger cross-sectional body than the first
penetration member.
2. The surgical marker of claim 1, wherein the marker comprises a
radiographically opaque material.
3. The surgical marker of claim 1, wherein the second penetration
member comprises a base operably coupled to a guard having a larger
cross-section than the base.
4. The surgical marker of claim 3, further comprising a groove
positioned between the guard and an upper section of the
marker.
5. The surgical marker of claim 4, wherein where the groove is an
annular groove.
6. The surgical marker of claim 1, wherein neither the first nor
the second penetration member comprises a cannula.
7. The surgical marker of claim 1, wherein the marker is configured
to align the placement of a surgical instrument when the second
penetration member is embedded in bone.
8. A kit for temporarily marking a bone comprising: a temporary
surgical marker comprising a first penetration member having a main
body, an apex configured to pierce bone, and a base that is
concentric and operably coupled to an apex of a second penetration
member configured to pierce bone, wherein the second penetration
member comprises a larger cross-sectional body than the first
penetration member; and an insertion device comprising means for
releasably housing said surgical marker such that said first and
second penetration members are exposed.
9. The kit of claim 8, wherein said means for releasably housing
the surgical marker comprise a release lever having a latch
configured to operably couple to the groove.
10. The kit of claim 7, wherein said insertion device further
comprises means for extracting the marker when its first or second
penetration member is embedded into bone.
11. The kit of claim 10, wherein said means for extracting the
marker comprise a flange configured to operably couple to the
groove.
12. The kit of claim 7, wherein neither the first nor the second
penetration member comprises a cannula.
Description
FIELD OF THE INVENTION
[0001] The embodiments herein relate to systems and methods useful
in the medical field and are directed to temporarily marking the
vertebrae in a patient in need. The assemblies and methods herein
have many applicable uses including the ability to allow a surgeon
to radiographically determine the location of a particular
vertebral body. Additionally, the teachings herein can be used to
locate a patient's vertebral midline, which is a useful
determination for a variety of surgical procedures, non-exclusively
including corpectomies and disectomies, for example.
BACKGROUND
[0002] When removing a disc from the spinal column, it is common
practice for a surgeon to place a radiographically opaque needle
into the exposed, potentially damaged disc and then view the needle
via X-ray to ensure that the marked disc's location signifies that
it is actually the damaged disc that is intended to be removed.
Determining the location is often done by counting the vertebral
bodies until the medical provider reaches the needled disc.
[0003] Unfortunately there are many problems associated with this
practice. One such problem is that surgeons often puncture the
wrong disc with the needle. This is understandably a common problem
as the reason for using the needle is to verify whether the needled
disc is in fact the damaged disc as opposed to a nearby healthy
disc. Puncturing a healthy disc is undesirable in itself, but even
more so when the needle pierces too far into the disc. While some
have attempted to prevent over-piercing by using guards (See U.S.
Pat. No. 5,195,526 to Michelson, hereinafter "Michelson I", for
example) the art does not appear to recognize that inserting
marking devices into a healthy disc area is deleterious in itself,
whether or not there is "over penetration." Accordingly, there is a
need to provide a system and method for radiographically
determining the position of a damaged disc without potentially
puncturing a healthy disc.
[0004] In addition to determining the position of an unhealthy
disc, it is often also advantageous to use a marking system in
order to determine the vertebral midline for proper graft, cage,
and/or artificial disc implantation. Unfortunately, current systems
and methods for determining the vertebral midline often involve
piercing the disc space. See U.S. Pat. No. 6,224,607 to Michelson,
hereinafter "Michelson II", for example. This is disadvantageous
for the same reasons as discussed above.
[0005] Marking systems used to determine the alignment of the
vertebral midline or to ascertain whether a penetrated disc is
damaged also overly rely on dyes for injecting into the disc space.
The use of dye requires unnecessary steps in spinal marking that
are more expensive, time consuming, requires a cannulated marker,
and allows for more human error in the marking procedure.
[0006] A further disadvantage of current marking systems is that
they are only used to mark the disc area, not to created
additional, larger holes for other instruments used in spinal
surgery.
[0007] Based on the above described problems, an objective of the
teachings herein is to provide improved systems and methods for
spinal marking that allow the operating surgeon to both identify
the position of the damaged disc targeted for removal and to
ascertain the position of the vertebral midline to allow for
aligned implantation after removal of the damaged disc, or portions
thereof. It is a further objective of the embodiments herein to
provide a spinal marking system that does not rely on dyes or
cannulated marking systems. Further objectives of the markers
provided herein are to act as a designated point upon which a
surgical instrument, such as a drill guide, can operably couple
with to obtain proper alignment.
SUMMARY OF THE INVENTION
[0008] Embodiments herein are directed to temporary surgical
markers having a first penetration member having an apex configured
to pierce bone, and a base that is concentric and operably coupled
to an apex of a second penetration member configured to pierce
bone, and having a larger cross-sectional body than the first
penetration member. Preferred markers are made entirely or in part
of a radiographically opaque material. If the markers are not
entirely made of a radiographically opaque material, it is
preferred that at least the first penetration member is. More
specifically, the first penetration member can be radiographically
opaque and the remaining marker can be radiographically lucent.
[0009] Preferably, the second penetration member includes a base
operably coupled to a guard having a larger cross-section than the
base. Preferred markers include a groove, such as an annular
groove, positioned between the guard and an upper section of the
marker. Advantageously neither the first nor the second penetration
member include a cannula and are not suitable to transmit dye to
the spine area. Preferred markers are configured to align the
placement of a surgical instrument when embedded in bone.
[0010] Preferred embodiments are also directed to kits for marking
a bone that include a temporary surgical marker comprising a first
penetration member having a main body, an apex configured to pierce
bone, and a base that is concentric and operably coupled to an apex
of a second penetration member configured to pierce bone and having
a larger cross-sectional body than the first penetration member;
and an insertion device comprising means for releasably housing
said surgical marker such that said first and second penetration
members are exposed.
[0011] Preferably, the means for releasably housing the surgical
marker comprise a release lever having a latch configured to
operably couple to the groove. Advantageous insertion devices can
further comprise means for extracting the marker when its first or
second penetration member is embedded into bone. Said means for
extracting the marker can include a flange configured to operably
couple to the groove. Preferably, neither the first nor the second
penetration member comprises a cannula.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] It will be appreciated that the drawings are not necessarily
to scale, with emphasis instead being placed on illustrating the
various aspects and features of embodiments of the invention, in
which:
[0013] FIG. 1 is a perspective view of a marker
[0014] FIG. 2 is a perspective view of marker insertion device
[0015] FIG. 3 is a perspective view of the insertion device
releasably coupled to a marker for insertion into a vertebral
body
[0016] FIG. 4 is a perspective view of the marker being partially
inserted into a vertebral body
[0017] FIG. 5 is a perspective view of the marker partially
inserted into a vertebral body.
[0018] FIG. 6 is a perspective view of the marker being removed
from the vertebral body
[0019] FIG. 7 is a perspective view of the marker being fully
inserted into the vertebral body
[0020] FIG. 8 is a perspective view of the fully inserted marker
being extracted from the vertebral body
[0021] FIG. 9 is a perspective view of the larger hole in the
vertebral body created after the fully inserted marker is
removed.
[0022] FIG. 10 is a perspective view of a drill guide.
[0023] FIG. 11 is a perspective view of the inserted marker being
used to align the drill guide.
[0024] FIG. 12 is a perspective view of an alternative marker
shape.
[0025] FIG. 13 is a perspective view of an alternative insertion
device with a release lever in the open position.
[0026] FIG. 14 is a perspective view of an alternative insertion
device with a release lever in the closed, natural position.
DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS
[0027] Embodiments of the present invention are described below. It
is, however, expressly noted that the present invention is not
limited to these embodiments, but rather the intention is that
modifications that are apparent to the person skilled in the art
and equivalents thereof are also included.
[0028] FIG. 1 depicts an example of a marker 2 that can be used
with the systems and methods herein. The bottom portion of the
marker 2 preferably includes a first penetrating member 4 that
includes a downward facing sharp point, or apex, configured to
pierce a patient's vertebral body 30. The first penetrating member
4 is preferably in the shape of a needle or a narrow, inverted
cone. Advantageously, the apex of the first penetrating member 4 is
configured to make a small test hole 36 in the vertebral body 30
when pressed in. Preferably, the first penetrating member 4
includes a base positioned at the opposite end of the apex that is
coupled to or traverses through the apex of a second penetrating
member 6. According to even more preferred embodiments, the first
and second penetrating members 4 and 6 are concentric with respect
to each other.
[0029] Preferably the second penetrating member 6 is in the shape
of an inverted wide cone, frustum, or pyramid and has a larger
diameter than the first penetrating member 4, or is otherwise
configured to make a larger hole 38 in the vertebral body 30,
compared to the hole 36 made by the first penetrating member 4.
More preferably the second penetrating member 6 is a right circular
cone. While the second penetration member 6 can have a smooth outer
surface, or substantially so, in other embodiments the second
penetrating member 6 can include grooves and/or protrusions (not
shown). These grooves or protrusions can traverse the slant height
of the second penetrating member 6, or be otherwise positioned to
make distinct indentations in the vertebral body 30. These grooves
and/or protrusions and their corresponding indentations in the
vertebral body 30 can be customized for various instruments or
implants designed to be inserted into the hole left by the second
penetrating member 6. Such surgical instruments or implants can
include, distractor/retractor pins, and pins for aligning fusion
plates or templates, for example. The first and second penetrating
members 4 and 6 are each preferably between 2-3.5 mm in length, or
2.5-3 mm in length, or 2.79 mm, or approximately so, in length.
[0030] According to more specific embodiments, preferred markers 2
can include a guard 8 positioned above and operably coupled to the
base of the second penetrating member 6. Advantageously the guard 8
prevents the second penetrating member 6 from inadvertently
penetrating too deep into the vertebral body 30. Preferred guards 8
can be a variety of shapes (e.g., cylindrical, tapered, spherical,
disc) and configurations, but include a larger cross-section (e.g.,
diameter) than the base of the second penetrating member 6.
Preferred guards 8 are relatively thick to prevent bending by the
marker 2. Guards 8 can advantageously be between 1-2 mm thick, or
between 1.25-1.75 mm thick, or 1.55 mm thick, or substantially
so.
[0031] Preferably, the markers 2 provided herein also include a
groove 12 positioned above the guard 8 and below an upper section
10. More preferably, the groove 12 can be an annular groove, or
semi-annular, or partially annular. The groove 12 can be used with
a corresponding tool to facilitate the extraction and/or
implantation of the marker 2 from or into the vertebral body 30. In
certain embodiments, grooves can have heights between 1.5-2.5 mm,
1.75 and 2.25 mm, or 2.01 mm, or substantially so. The upper
section 10 is positioned above the groove 12 and has a larger
diameter than the groove 12. The diameter of the upper section 10
can be the same or similar size as the diameter of the guard 8, and
can be configured to a variety of suitable shapes (e.g.,
cylindrical, tapered, spherical, or disc). The upper section 10 can
include a top side 14 surface that can be readily detected by a
viewer after anterior/posterior imaging (e.g., X-ray). The height
of the upper section 10 can be between 1.75-3.25 mm, 2-3 mm, or
2.55 mm or substantially so.
[0032] A second embodiment of marker 2a is depicted in FIG. 12 and
is essentially the same as the first marker 2, depicted in FIG. 1
and described above, with the exception of having a rounded top
side 16 instead of a substantially planar top side 14. The usage of
the term "marker" herein, regardless of the reference number
associated with the term, is expressly contemplated to include both
embodiments of markers 2 and 2a.
[0033] Preferred markers 2 are low profile and have heights from
the tip of the first penetrating member to the top of the marker
that can be less than the following values: 2 cm, 1.5 cm, or 1 cm.
Preferred markers have a height range between 0.5-1.5 cm, or
between 0.8-1.3 cm, or a total height of 11.69 mm, or approximately
so. The low profile is an advantageous design as it prevents the
bending of the marker 2. Additional embodiments are directed to
markers 2 that are not cannulated, and thus do not rely on guide
wires or dyes. More specifically, according to these embodiments,
neither the first nor second penetrating members 4 and 6 require a
centrally located cannula that traverses to the apex of the first
penetrating member, as they do not rely on syringes, inserting dyes
into the disc space, or guide wires for insertion.
[0034] According to preferred embodiments, the markers 2 provided
herein are entirely or partially radiographically opaque and are
preferably made of metal, such as stainless steel, or titanium, for
example. If the marker is partially radiographically opaque, it is
preferred that at least the first penetrating member is
radiographically opaque. The remaining part of the marker can be
radiolucent.
[0035] A first embodiment insertion device 20 is shown in FIG. 2.
Preferably, the inserter 20 includes means for inserting the marker
2. One example of a means for inserting the marker 2 is a cavity 24
positioned within the bottom end of the inserter 20 and that is
configured to house the guard 8, groove 12, and upper section 10 of
the marker 2 while leaving the first and second penetrating members
4 and 6 exposed for piercing the vertebrae 30. Alternatively, the
cavity can additionally be opened on the lateral side of the
insertion device such that the guard 8, groove 12 and upper section
10 of the marker 2 are partially exposed. While the cavity 24 can
be cylindrical in shape, alternative shapes of cavities can be used
depending on the specific shape of the marker used. For example,
FIG. 13 depicts a second embodiment of insertion device 20a having
a rounded cavity 24a (e.g., pill shaped or semi-pill shaped) to
house a marker 2a having a rounded top 16.
[0036] The means for inserting the marker 2 allow the operating
surgeon to apply downward pressure onto the insertion device 20
coupled to the marker 2 such as to be able to push said first
penetrating member 4 or second penetrating member 6 into the
vertebrae 30. More specifically, when the surgeon applies a first
amount of pressure, the first penetrating member 6 will pierce the
vertebrae 30 and create a small test hole 36. If the surgeon then
applies a second amount of pressure, greater than the first, the
second penetrating member 8 can pierce the vertebral body 30 and
create a larger hole 38.
[0037] Preferred markers 2 can be configured to allow the first
penetration member 4 to be relatively easily pushed into the
vertebral body 30 while the second penetration member 6 can be
configured to require more force to penetrate the vertebrae 30 as
it is not as sharp as the first penetration member 4. Preferably,
the cross-sectional perimeter of the second penetration member 6 is
larger than the cross-sectional perimeter of the first penetration
member 4, and shaped such that it gradually increases from its
bottom end to top end. Because of the larger perimeter, the second
penetration member 6 will require additional force to insert it
into the vertebral body 30 beyond that required for insertion of
the first penetration member 4. By controlling the downward
pressure on the marker 2, the surgeon can choose whether the second
penetration member 6 is pressed into the vertebrae 30 and the
amount of penetration.
[0038] The marker 2 can be held in its' cavity 24 by a light magnet
or through any suitable release lever. One example of a release
lever 50 is depicted in FIGS. 13 and 14. The release lever 50
preferably includes a release button 54 that when pushed releases a
latch 52 configured to fit within the groove 12 of the marker 2a
(FIG. 13). Preferably, when the release button 54 is in its natural
state (FIG. 14), the latch 52 holds the marker 2a within the cavity
24a of the insertion device 20a. In other embodiments, the release
lever 50 can also be used to extract the marker 2a when imbedded in
the vertebrae 30. Advantageously, a second release lever (not
shown) can be used with a first release lever such that two latches
grip the groove 12 of the embedded marker 2a. Alternatively, the
second insertion device 20a can include a flange (e.g., annular or
semi-annular) on its end opposite from the insertion cavity 24a
configured to fit within the groove 12 for extracting an embedded
marker 2a.
[0039] Other insertion means for the markers 2 provided herein
non-exclusively include screwdrivers, electric screwdrivers,
mallets, or wrenches for markers with corresponding modified heads
(e.g., Phillips, hex, or flat).
[0040] Preferred insertion devices 20 can preferably include means
for removing the marker 2 from the vertebral body 30. Referring to
FIG. 2, the top end of the inserter 20 includes means for removing
a marker 2 having either its first or second penetration member 4
or 6 imbedded into the vertebral body 30. The means for removal can
be any suitable means that couple to the marker 2 and allow the
surgeon to pull the first or second penetrating member 4 or 6 out
from the vertebral body 30. FIG. 2. depicts a means for removal
that includes an elevated member 22 supporting a flange 26 in the
shape of a semi-circle (or is otherwise arched) and is configured
for coupling to the groove 12 on the marker 2. Once coupled to the
groove 12, the flange 26 catches against the upper section 10 of
the marker 2 and allows the surgeon to lift out either the first or
second penetrating members 4 or 6 from the vertebrae 30. Another
non-exclusive means for extracting the embedded marker 2 can
include a cavity that opens on the lateral side of the insertion
device that include one or more flanges configured to couple to the
groove 12.
[0041] Other non-exclusive means for removing an embedded marker 2
can include one or more of the following members: clamp,
retractable flange, or pliers, for example. These means can be
separate from the insertion device 20 or alternatively coupled to
it.
[0042] Preferred methods of using the markers 2 described herein
are also contemplated. One preferred method is to use the markers 2
to test and verify which particular vertebral body or bodies (e.g.,
C5, C6, and C7) are exposed at the surgical site. Before exposing
the vertebral area targeted to be operated on, the surgeon
typically estimates externally where the targeted site on the
patient is. Once the opening cut has been made and the spinal area
is exposed, a surgeon should verify that the exposed site is indeed
the targeted site for surgery.
[0043] As shown in FIGS. 3-9, the first penetrating member 4 can be
used to make a first, test hole 36 in an exposed vertebral body 30
and the second penetrating member 6 can be used to make a final
hole 38 in the vertebral body 30.
[0044] As exemplified in FIGS. 3 and 4, a surgeon can embed a
marker's first penetration member 4 into the exposed vertebrae 30.
After embedding the first penetration member 4 into the vertebral
body 30, the insertion device 20 is disengaged from the marker 2 as
shown in FIG. 5. The position of the marker 2 with the embedded
first penetration member 4 can then be verified using an X-ray, or
other available imaging tools. For example, an anterior/posterior
and/or lateral X-ray can be taken showing the marker 2 embedded in
the vertebral body 30 and more preferably, one or more unmarked
vertebral bodies (e.g., such as the adjacent vertebral body 32) in
the patient's spine. Reviewing the X-ray, the surgeon can determine
which specific vertebral body 30 is marked by counting vertebral
bodies from a known vertebral body to verify that the correct
surgical site in the spine is marked. The Cl vertebral body on the
X-ray, for example, can be used as a starting point for counting to
the marked vertebral body 30. Additionally, the surgeon can review
the anterior/posterior X-ray to verify that the marker 2 is
positioned along the vertebral midline 40 if so desired.
[0045] If the X-rayed marker's 2 test position is in the incorrect
vertebral body or in the wrong position on the correct vertebral
body (e.g., not along the vertebral midline 40), the marker 2 can
be removed using means for extraction as shown in FIG. 6, and a new
test hole at another location on the same vertebral body 30 or into
a different vertebral body 32 can be made. The position of the
second and subsequent test positions can again be verified by
X-ray. Once the desired location has been obtained with the first
penetrating member 4, the marker 2 can be pressed further into the
vertebral body 30 such that the second penetrating member 6 makes a
larger hole 38 in the vertebral body 30. The embedding of the
second penetration member 6 is exemplified in FIG. 7. Determining
whether the first penetration member 4 of the marker 2 is pressed
into the correct location before pressing the second penetrating
member 6 into the vertebrae 30 can be ascertained in a variety of
ways, non-exclusively including, directly viewing the site, a
lateral X-ray view, or anterior/posterior X-ray view, for
example.
[0046] According to preferred embodiments, the larger hole 38 can
be used either as a better target and/or a location to position
other surgical instrumentation, such as distraction pins, for
example. Advantageously, the systems and methods provided herein
allow the surgeon to first create smaller test holes 36 in the
vertebral body until the desired position is obtained, and then a
larger hole 38 can be made. According to certain embodiments, the
second penetrating member 6 does not include an entirely smooth
outer surface, but can includes protrusions or indentations that
are configured to make specialized holes in the vertebral body 30
to accommodate various instruments or implants, such as
distractor/retractor pins, or drill guides, for example. According
to the teachings herein, it is highly advantageous to have a single
marker 2 configured to have the ability to make both a smaller test
hole(s) 36 and larger hole(s) 38 in a vertebral body 30.
[0047] Additional embodiments are directed to methods of using the
markers 2 herein as fixed points for aligning surgical
instrumentation. One example of these methods is exemplified in
FIGS. 10 and 11. FIG. 10 depicts a drill guide 42 that can be
aligned with the marker 2 embedded in the vertebrae 30. In this
example, the drill guide 42 includes a handle 44 operably coupled
to upper frame 45 comprising aiming ports 47 and a lower alignment
guide 46 comprising a pair of parallel bars. The drill guide 42 is
configured to be held in place by anchoring spikes 48 facing the
patient's spine.
[0048] With reference to FIG. 11, the embedded mark 2 is configured
to be straddled by the parallel bars of the alignment guide 46 and
the anchoring spikes 48 pierce the disc space. Thus, the marker 2
can ensure the drill guide 42, or another surgical instrument, is
aligned how the surgeon desires, such as along the vertebral
midline 40, for example. Once the drill guide 42 is aligned and
anchored, a surgeon can drill in the unmarked vertebrae 32 through
one of the aiming ports 47, and between the parallel bars of the
alignment guide 46. Additionally, the marker 2 can be extracted and
the surgeon can guide a drill through one of the aiming ports 47
into the larger hole 38 created by the second penetration member 6.
The drilled holes are preferably configured to set a distractor pin
for separating the disc space between the vertebral bodies 30 and
32. The fixed distractor pins can in turn, be used to align a
fusion plate or template. Alternatively, the distractor pins, or
other types of instruments, can be secured directly (e.g., screwed)
into the one or more larger holes 38 made in the vertebrae without
a drill.
[0049] In other embodiments a second marker (not shown) can be
placed in the same or the adjacent vertebrae 32 such that there are
two fixed points for the alignment guide 46 bars to straddle and/or
two holes for instruments to be secured into.
[0050] The invention may be embodied in other specific forms
besides and beyond those described herein. The foregoing
embodiments are therefore to be considered in all respects
illustrative rather than limiting, and the scope of the invention
is defined and limited only by the appended claims and their
equivalents, rather than by the foregoing description. All
references provided herein are expressly incorporated by reference
in their entireties.
* * * * *