U.S. patent application number 13/046140 was filed with the patent office on 2011-07-07 for spine implant insertion device and method.
This patent application is currently assigned to G&L Consulting. Invention is credited to Nicholas Gately.
Application Number | 20110166654 13/046140 |
Document ID | / |
Family ID | 37188055 |
Filed Date | 2011-07-07 |
United States Patent
Application |
20110166654 |
Kind Code |
A1 |
Gately; Nicholas |
July 7, 2011 |
SPINE IMPLANT INSERTION DEVICE AND METHOD
Abstract
A spinal implant include a top, wherein at least a portion of
the top is configured to contact a first vertebra, a bottom,
wherein at least a portion of the bottom is configured to contact a
second vertebra, a side having a releasable attachment to receive
an insertion device and a cam surface to engage a cam on the
insertion device
Inventors: |
Gately; Nicholas;
(Lambertville, NJ) |
Assignee: |
G&L Consulting
New York
NY
|
Family ID: |
37188055 |
Appl. No.: |
13/046140 |
Filed: |
March 11, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11278552 |
Apr 4, 2006 |
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13046140 |
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60669356 |
Apr 8, 2005 |
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Current U.S.
Class: |
623/17.11 |
Current CPC
Class: |
A61F 2002/2835 20130101;
A61F 2230/0015 20130101; A61F 2220/0025 20130101; A61F 2002/30495
20130101; A61F 2310/00796 20130101; A61F 2/4611 20130101; A61F
2002/30904 20130101; A61F 2002/4629 20130101; A61F 2002/4627
20130101; A61F 2002/30538 20130101; A61F 2/4465 20130101; A61F
2310/00359 20130101; A61F 2310/00179 20130101; A61F 2002/30906
20130101; A61F 2002/30601 20130101; A61F 2310/00011 20130101; A61F
2002/30593 20130101; A61F 2250/0006 20130101; A61F 2002/30133
20130101; A61F 2310/00407 20130101; A61F 2/28 20130101 |
Class at
Publication: |
623/17.11 |
International
Class: |
A61F 2/44 20060101
A61F002/44 |
Claims
1. A method to surgically insert a spinal implant between vertebra
in a mammalian patient using an insertion tool, the method
comprising: releasebly attaching the spinal implant to a distal
portion of the insertion tool; inserting the spinal implant between
the vertebra while the spinal implant is attached to the distal
portion; while the spinal implant is between the vertebra,
manipulating a proximal region of the insertion tool to force the
spinal implant to make a yaw movement with respect to an axis of
the distal portion, and after making the yaw movement, releasing
the distal portion from the spinal implant and removing the
insertion tool from the patient while the spinal implant remains
between the vertebra.
2. The method as in claim 1 wherein the manipulation of the
proximal region includes turning a tube about a rod coaxial to the
tube, wherein the step of releasably attaching includes attaching a
distal end of the rod to the spinal implant and the yaw movement is
made by turning a distal end of the tube against the implant.
3. The method of claim 1 further comprising locking the implant at
a first angle relative to the shaft of the instrument prior to the
insertion of the implant.
4. The method of claim 3 wherein the implant such that a
longitudinal axis of the implant is generally aligned with a
longitudinal axis of the insertion tool.
5. The method of claim 1 wherein turning the shaft rotates a cam
fixed to the shaft across a cam surface on the implant.
6. The method of claim 5 wherein the cam surface is slanted and the
movement of the cam across the cam surface pivots the implant.
7. The method of claim 1 wherein the manipulation of the proximal
end of the tool is performed without tilting a shaft between the
proximal region and distal region.
8. The method of claim 7 wherein during the steps of the insertion,
the manipulation and the removal, a shaft between the proximal
region and the distal portions remains aligned along a single
line.
9. The method of claim 1 wherein the yaw movement is within a plane
parallel to a shaft between the proximal region and the distal
portion.
10. A method comprising: inserting an implant into a patient;
loosening the implant relative to the shaft; turning the shaft
about an axis of the shaft to pivot the implant relative to the
shaft, and releasing the implant from the instrument so that the
implant is in position between the bone.
11. The method of claim 10 further comprising locking the implant
at a first angle relative to the shaft of the instrument prior to
the insertion of the implant.
12. The method of claim 10 wherein turning the shaft rotates a cam
fixed to the shaft across a cam surface on the implant.
13. The method of claim 10 wherein the cam surface is slanted and
the movement of the cam across the cam surface pivots the
implant.
14. An assembly of a spinal implant and an insertion tool to insert
the spinal implant between vertebras wherein the insertion tool
comprising: a shaft assembly including a hollow tube concentric
with a rod; a distal portion of the rod including a coupling for
releasably attaching to the spinal implant; a distal portion of the
hollow tube having a cam surface adapted to engage an opposing cam
surface on the spinal implant, and a proximal region of the shaft
assembly including a first grip to rotate the hollow tube about the
rod and a second grip to rotate the rod within the hollow tube, and
the spinal implant comprising: a pivoting pin within a housing on
the implant, the pivoting pin adapted to couple to the coupling of
the distal portion of the rod, wherein the pivoting pin is
perpendicular to a longitudinal axis of the shaft assembly, and the
opposing cam surface is adjacent the housing.
15. The assembly in claim 14 wherein the opposing cam surface is
aligned with a line extending through a longitudinal axis of the
pin.
16. The assembly in claim 14 wherein the housing has a
hemispherical outer surface and the opposing cam surface is
adjacent the hemispherical outer surface.
17. The assembly in claim 14 wherein the cam surface is a planer
surface.
18. The assembly in claim 14 wherein the pin includes a threaded
aperture to receive a threaded tip at the distal portion of the
rod.
19. The assembly in claim 14 wherein the housing and opposing cam
surface are on a side of the spinal implant.
20. The assembly as in claim 19 where the spinal implant includes
an upper surface and a lower surface each adapted to engage one of
the vertebras, and wherein the side extends from the upper surface
to the lower surface.
21. The assembly as in claim 14 wherein the implant includes at
least one of allograft bone, xenograft bone and autograft bone.
22. A method to surgically insert a spinal implant between vertebra
in a mammalian patient using an insertion tool, the method
comprising: releasebly attaching the spinal implant to a distal
portion of a shaft of the insertion tool; inserting the spinal
implant between the vertebra while the spinal implant is attached
to the distal portion of the shaft; while the spinal implant is
between the vertebra, manipulating a proximal region of the
insertion tool to force the spinal implant to make a yaw movement
with respect to an axis of the distal portion while the shaft
remains substantially aligned with respect to a stationary straight
line extending from between the vertebra, and after making the yaw
movement, releasing the distal portion from the spinal implant and
removing the insertion tool from the patient while the spinal
implant remains between the vertebra.
23. A method to insert a spinal implant between vertebra of a
mammalian patient, the method comprising: forming a space for the
spinal implant between adjacent vertebra; attaching the spinal
implant to an end of a center shaft of an insertion tool, wherein
the insertion tool includes a tubular shaft coaxial to the center
shaft; aligning the spinal implant with an axis of the shaft before
inserting the spinal implant into the patient and while the spinal
implant is positioned in or proximate to the space between the
adjacent vertebra; after positioning the spinal implant in or
proximate to the space between the adjacent vertebra, rotating the
tubular shaft about the center shaft to pivot the spinal implant
relative to the center shaft, and releasing the spinal implant from
the center shaft so that the implant remains between the vertebra
and the insertion tool may be removed from the patient.
24. The method of claim 23 further comprising locking the spinal
implant into the alignment with the axis of the shaft while the
implant and center shaft are inserted into the patient and
releasing the locking to rotate the tubular shaft and pivot the
spinal implant.
26. The method of claim 24 wherein pivoting the spinal implant
includes moving the spinal implant in a yaw direction with respect
to the center shaft and holding the center shaft stationary while
the spinal implant moves in the yaw direction.
Description
[0001] This application is a continuation of U.S. Non-Provisional
Utility application Ser. No. 11/278,552, filed Apr. 4, 2006, and
claims the benefit of U.S. Provisional Patent Application Ser. No.
60/669,356 filed Apr. 8, 2005, both of which applications are
incorporated by reference.
BACKGROUND OF THE INVENTION
[0002] The present invention generally relates to the field of
medical devices. Some embodiments of the invention relate to spinal
implants inserted in the spine of a patient during surgical
procedures and to instruments used to insert the implants. Other
embodiments of the invention relate to methods for positioning,
rotating and advancing an implant during a surgical procedure.
[0003] A spinal implant may be used to stabilize a portion of a
spine. The implant may promote bone growth between adjacent
vertebra that fuses the vertebra together. The implant may include
a spherical protrusion, a threaded pin and an angled surface to
facilitate remote adjustment of the implant position using an
insertion instrument.
[0004] The insertion instrument may include, but is not limited to,
a threaded rod, an actuator and a lock knob. The insertion
instrument can be attached and detached to the implant, rotate the
implant by transferring torque from the actuator to the implant.
The actuator can be used to lock the implant in relation to the
instrument. The rod can be used to apply force to the implant and
advance it. The implant and instruments may be supplied in an
instrument kit.
[0005] An intervertebral disc may degenerate. Degeneration may be
caused by trauma, disease, and/or aging. An intervertebral disc
that becomes degenerated may have to be partially or fully removed
from a spinal column. Partial or full removal of an intervertebral
disc may destabilize the spinal column. Destabilization of a spinal
column may result in alteration of a natural separation distance
between adjacent vertebra. Maintaining the natural separation
between vertebra may prevent pressure from being applied to nerves
that pass between vertebral bodies. Excessive pressure applied to
the nerves may cause pain and nerve damage.
[0006] During a spinal fixation procedure, a spinal implant may be
inserted in a space created by the removal or partial removal of an
intervertebral disc between adjacent vertebra. The spinal implant
may maintain the height of the spine and restore stability to the
spine. Bone growth may fuse the implant to adjacent vertebra.
[0007] A spinal implant may be inserted during a spinal fixation
procedure using an anterior, lateral, posterior, or transverse
spinal approach. A discectomy may be performed to remove or
partially remove a defective or damaged intervertebral disc. The
discectomy may create a space for a spinal implant. The amount of
removed disc material may correspond to the size and type of spinal
implant to be inserted.
[0008] Spinal implants are described in U.S. Pat. No. 5,653,763 to
Errico et al.; U.S. Pat. No. 5,713,899 to Marney et al.; U.S. Pat.
No. 6,143,033 to Paul et al.; U.S. Pat. No. 6,245,108 to Biscup;
and U.S. Pat. No. 5,609,635 to Michelson, United States Patent
Application 20050027360 to Webb.
BRIEF DESCRIPTION OF THE INVENTION
[0009] A spinal implant is disclosed comprising: a top, wherein at
least a portion of the top is configured to contact a first
vertebra; a bottom, wherein at least a portion of the bottom is
configured to contact a second vertebra and a side having a
releasable attachment to receive an insertion device and a cam
surface to engage a cam on the insertion device. The spinal implant
may include a hemispherical mount and a pin mounted within the
spinal implant, wherein the insertion device attaches to the pin
that serves as an axis of rotation and pivots around the pin with
respect to the hemispherical housing.
[0010] A method is disclose comprising: inserting an implant
between portions of bone, wherein the implant locked at a first
angle relative to a shaft of the instrument; loosening the implant
relative to the shaft; turning the shaft to pivot the implant
relative to the shaft, and releasing the implant from the
instrument so that the implant is in position between the bone.
Turning the shaft rotates a cam fixed to the shaft across a cam
surface on the implant, wherein the cam surface is slanted and the
movement of the cam across the cam surface pivots the implant.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 is a top-side perspective view of a spinal implant
attached to an insertion instrument.
[0012] FIG. 2 is an exploded view showing the spinal implant
separate from the insertion instrument.
[0013] FIG. 3 is a perspective view of the FIG. 3 illustrates the
interaction between the Actuator 202 of the instrument and the
implant 100.
[0014] FIG. 4 is a perspective view of the implant releasably
attached to the insertion instrument and positioned over a
vertebra.
DETAILED DESCRIPTION OF THE INVENTION
[0015] FIG. 1 shows the spinal implant 100 releasably attached to
an insertion instrument 200. The implant 100 may be made by made of
PEEK plastic commonly used in spinal implants. The implant includes
a hemispherical mount 105 and slanted cam surface 106 from which
the mount protrudes. The tip of rod 201 pivotably attaches to the
mount such that the implant may pivot with respect to the axis of
the instrument. The pivoting of the implant is controlled by the a
knob on the instrument that rotates the cam wings 205 about the
hemispherical surface. The rotation of the cam, slides the front
edges of the cam wings across the and cam surface 106 and thereby
forces the implant to pivot with respect to the axis of the
instrument.
[0016] A knob (e.g. actuator wings) 206 on the on the proximal end
of the instrument enables a surgeon to rotate the cam and thereby
adjust the angle between the implant and the axis of the
instrument. Pivoting of the implant is caused as the actuator
pushers 205 (e.g., cam) act on the slanted surface 106 of the
implant 100. As the cammed actuator 202 rotate and slide across the
slanted surface 106, the implant makes a yaw movement with respect
to the axis of the instrument. Actuator 202 is equipped with the
actuator wings 206 used to rotate pushers 205 (cam) from outside of
the patient's body.
[0017] Locking knob 207 may be tightened to bind the actuator
against the implant effectively locking the implant with respect to
the instrument. When locked, axial force and torque can be applied
to the handle 204 to advance the implant into the spinal space and
position the implant in the space. Turning the locking knob 207
that is threaded inside and engages threads on the proximal end of
the rod causes the actuator 202 that is hollow to slide axially
forward over the threaded rod 201 and thereby loosen or tighten the
actuator against the implant.
[0018] FIG. 2 shows the details of the attachment of the implant
100 to the instrument 200. Threaded pin 102 is inserted into the
channel 107 in the spherical protrusion (mount) 105 and retained
there by a snap ring 103. A threaded hollow shaft 108 in the
threaded pin 102 is aligned with the slot opening 109 of the
implant so that the treaded rod 201 can be threaded into the shaft
108 of the pin 102. Slot opening allows pivoting of the implant by
accommodating the pendulum motion of the rod 201. Pin 104 is made
of a material that enhances X-ray imaging. Making the pin visible
assists the physician in the positioning of the implant while
viewing a real-time x-ray image of the implant and vertebra.
[0019] The actuator 202 may be a hollow tube that is coaxial with
the rod 201. The pushers are fixed to the distal end of the
actuator. The pushers 205 include cams that engage a cam surface
106 on the implant. The proximal end of the tube has a knob (e.g.
actuator wings) 206 to turn the tube and thereby move the cams
against the cam surface. The angle of the implant with respect to
the implant is adjusted by moving the cam against the cam surface.
Adjusting the angle may allow the surgeon to properly place the
implant in the spine area.
[0020] FIG. 3 illustrates the interaction between the Actuator 202
of the instrument and the implant 100. The actuator 202 is rotated
around the axis of the threaded rod 201 that is engaged in the
threaded pin 102. As the cammed pushers 205 rotate, they push
against the surface 106. As a result the implant 100 turns around
the axis of the pin 102. It can be envisioned as if the implant is
performing a "dog wagging its tail" motion with respect to the
insert instrument 200.
[0021] If the locking knob 207 (FIG. 1) is rotated, the actuator
202 is pushed against the implant 100. Both pushers are advanced
towards the surface 106 to bind the actuator against the implant so
as to lock the implant with respect to the instrument. When locked,
the assembly of the implant and instrument can be advanced while
retaining the desired angle of the implant 100 in relation to the
insertion instrument 200.
[0022] FIG. 4 shows the implant 100 with the insertion instrument
200 attached and in position on a patient vertebra 401. Rotation of
the actuator 202 in relation to the axis of the threaded rod 201
results in the rotation of the implant 100 around the axis of the
pin 102. Rotation of the knob 207 pushes the actuator 202 into the
implant locking the assembly. When the assembly is locked hammer
tapping can be applied to the handle 204 to advance the assembly
forward.
[0023] A spinal implant may be used to stabilize a portion of a
spine. The implant may promote bone growth between adjacent
vertebra that fuses the vertebra together. An implant may include
an opening through a height of a body of the implant. The body of
the implant may include curved sides. A top and/or a bottom of the
implant may include protrusions that contact and/or engage
vertebral surfaces to prevent backout of the implant from the disc
space.
[0024] A spinal implant may be used to provide stability and
promote fusion of adjacent vertebra. The implant may be used in
conjunction with a spinal stabilization device such as a bone plate
or rod-and-fastener stabilization system. The implant may establish
a desired separation distance between vertebra. The implant may
promote bone growth between adjacent vertebra that fuses the
vertebra together. Instrument at is necessary for insertion of an
implant in a patient and alignment of the implant in the space.
[0025] A discectomy may be performed to establish a disc space
between vertebra. The disc space may be prepared for implant
insertion by distraction of adjacent vertebra, rasping and filing
of the bone to achieve the desired spacing.
[0026] It is desired to perform insertion of the implant and
positioning of the implant using minimum number of inserted
instruments and thought the smallest possible insertion channel in
the body.
[0027] Implants may be constructed of biocompatible materials
sufficiently strong to maintain spinal distraction. Implants may
include, but are not limited to, allograft bone, xenograft bone,
autograft bone, metals, ceramics, inorganic compositions, polymers
such as PEEK, or combinations thereof. If the implant is not made
of bone, surfaces of the implant that contact bone may be treated
to promote fusion of the implant to the bone. Treatment may
include, but is not limited to, applying a hydroxyapatite coating
on contact surfaces, spraying a titanium plasma on contact
surfaces, and/or texturing the contact surfaces by scoring,
peening, implanting particles in the surfaces, or otherwise
roughening the surfaces.
[0028] In some embodiments, an implant may include an opening that
extends through a body of the implant. The opening may have a
regular shape or an irregular shape. Bone graft may be placed in
the opening. The bone graft may be autogenic bone graft, allogenic
bone graft, xenogenic bone graft, and/or synthetic bone graft. Some
implant embodiments may be constructed from allogenic bone, such as
cortical bone from a femur, tibia, or other large bone. In some
embodiments, an implant may be formed from one or more pieces of
allograft bone cut to a desired shape.
[0029] In certain embodiments, sides of an implant may be shaped to
increase contact between an implant and adjacent vertebra with
notches, ribs and other similar features. Increasing contact of an
implant with adjacent vertebra may inhibit movement of the implant
after insertion. An increased contact area between an implant and
adjacent vertebra may promote bone growth between adjacent
vertebra.
[0030] In some embodiments, one or more sides of an implant may be
curved. One or more curved sides of an implant may allow the
implant to be maneuvered in a disc space during insertion of the
implant. The curvature of a side may approximate a curvature of an
anterior side of a vertebra adjacent to which the implant is
inserted.
[0031] Instruments may be used to prepare a space for an implant
between adjacent vertebra. An instrument may be used to insert an
implant in a prepared space. Instruments may be supplied to a
surgeon or surgical team in an instrument set. An instrument set
may include one or more implants for use during an insertion
procedure. An instrument set may include implants of various sizes
and/or lordotic angles to allow selection of an implant to suit a
patient during surgery. Instrument is attached to the implant
before the insertion into the body. When the desired position of
the implant is achieved, instrument is disengaged from the implant
and can be extracted from the body.
[0032] An instrument acts as an implant inserter. The implant
inserter may be used to push the implant and to rotate the implant.
After insertion of the implant, the implant may be released from
the inserter without the application of significant repositioning
forces to the implant. It can be imagined that the insertion
instrument can be screwed into the implant using threads or use
other techniques such as a tightening collet, jamming or grabbing.
In the disclosed embodiment the implant turns around the axis of
the implant pin as a result of the rotation of cam pushers. It can
be imagined that other mechanisms can be used to rotate the implant
such as ratchets or threaded push rods. The implant inserter may
have a low profile that allows for visualization of the implant and
surrounding area during insertion of the implant. Implant is
equipped to couple and uncouple from the instrument.
[0033] While the invention has been described in connection with
what is presently considered to be the most practical and preferred
embodiment, it is to be understood that the invention is not to be
limited to the disclosed embodiment, but on the contrary, is
intended to cover various modifications and equivalent arrangements
included within the spirit and scope of the appended claims.
* * * * *