FIELD OF THE INVENTION
[0001] This invention relates generally to securement devices and, more particularly, to
a device capable of flexibly securing vertebrae together.
BACKGROUND OF THE INVENTION
[0002] The lumbar spine absorbs a remarkable amount of stress and motion during normal activity.
For the majority of the population, the healing response of the body is able to stay
ahead of the cumulative effects of injury, wear, and aging, and yet still maintain
stability with reasonable function. In some cases, however, the trauma or stress exceeds
the ability of the body to heal, leading to local breakdown and excessive wear, and
frequently also leads to local instability. Accordingly, degenerative change with
age superimposed on baseline anatomy in the lumbar spine leads to problems including
instability, pain and neurologic compromise in some patients. In some cases, the local
anatomy may not provide the same protection to the motion segment, thereby aggravating
this breakdown. Although rehabilitation, conditioning, the limitation of stress, and
time to recover are effective treatments for most patients, there is a significant
failure rate with persistent pain, disability and potential neurologic deficit.
[0003] Referring now to Figs. 1, and 2, two side views of a pair of adjacent vertebral bodies
are shown. Figure 1 illustrates two vertebra V
1 and V
2 of the spine in a neutral position. As shown in Fig. 2, when a person leans forwards,
the spine undergoes flexion. The anterior portion of the spine comprises a set of
generally cylindrically shaped bones which are stacked one on top of the other. These
portions of the vertebrae are referred to as the vertebral bodies VB, and VB
2, and are each separated from the other by the intervertebral discs D. The pedicles
P
1 and P
2 comprise bone bridges which couple the anterior vertebral body VB to the posterior
portion of each vertebra. At each intervertebral joint or disc D, flexion involves
a combination of anterior sagittal rotation and a small amplitude anterior translation.
[0004] The intervertebral joint is a complex structure comprising an intervertebral disk
anteriorly, and paired zygapophyseal joints posteriorly. The disk functions as an
elastic support and connection between the vertebra, and allows for flexion and extension
of the spine, as well as limited rotation and translation. The zygapophyseal joints
and associated anatomy allow for significant flexion and extension while providing
constraints in translation and rotation.
[0005] The primary bending motion in the lumbar spine is flexion and extension in an anterior/posterior
plane. This occurs in the range approximating 10-15 degrees of flexion and extension.
In a young or normal lumbar spine, this motion occurs about an axis in the mid to
posterior portion of the disk. This is associated with a distraction or subluxation
of the facet joints or posterior elements of 10-15 mm. This occurs not about a pure
axis, but about a neutral zone, or a centroid of rotation associated with the lumbar
disk. The normal elasticity of the disk, joints and ligaments, and the degree of play
or freedom associated with these joints, as well as the nature of the loads applied
to the spine contribute to the size of this region of rotation. In some cases, the
recurrent loads and motion on the disk and associated trauma to disk and motion segment
exceed the natural rate of healing or repair of the body. In this situation, there
is breakdown in the motion segment associated with loss of the normal axis of rotation.
As increasing subluxation occurs with segmental motion, there is a dramatic shift
in the axis of rotation with displacement occurring within the disk space or frequently
to some point outside of the disk. Therefore, in the situation of a failing motion
segment, there is breakdown in the centroid of rotation with associated translation
of the vertebral segments. This translation is allowed by both breakdown occurring
in the disk and instability associated with both wear and degeneration of the zygapophyseal
joints. The underlying anatomy of the motion segment and joints allows for significantly
greater stress on the disc and contributes to degeneration both in the disk and joints.
[0006] Traditionally, surgical treatment has been directed at treating neural compromise,
or if the pain, instability, or risk of instability is considered sufficient, a segmental
fusion has been considered. More recently, stabilization procedures have been tried
over the past several years including artificial disks and ligaments and elastomeric
constructs to protect the spine. Arthroplasty techniques to maximize function and
reduce the dynamic effects on adjacent segments are a more recent approach with less
follow-up as to long-term results. A challenge in designing such a system is constraining
motion in a normal physiologic range.
[0007] Spinal fusion surgery is a method of fusing at least two mobile segments of the spine
to knit them together as one unit and eliminate motion between the segments. Current
spinal fixation systems offer several drawbacks. Rigid fusion constructs do not allow
relative movement between the vertebrae that are fused using a construct comprising
a pedicle screw, connector mechanism, and rigid rod. Furthermore, rigid implants are
known to create significant amounts of stress on the components of the construct,
including the pedicle screws and the rod, as well as the bone structure itself. These
stresses may even cause the rigid rod to break. In addition, the stresses transferred
to the pedicle screws may cause the screws to loosen or even dislodge from the vertebrae,
thereby causing additional bone damage.
[0008] Artificial disks may replace a failing disk and approximate a normal centroid or
axis of rotation; however, placement of such a device is technically demanding and
replaces the normal disk with a mechanical replacement with uncertain long-term results.
The artificial disk will be subject to wear without the healing potential of the body
to heal itself.
[0009] It is also desirable with some patients to have a spinal implant system that allows
the vertebral column to settle naturally under the weight of the human body. Human
bone heals more readily under some pressure. In a rigid spinal implant system, the
patient's spinal column may be unnaturally held apart by the structure of the implant.
It is possible that this stretching of the vertebrae, in relation to one another,
results in delayed or incomplete healing of the bone.
[0010] Posterior devices placed with pedicle fixation may provide some stabilization, however,
the natural motion of such devices does not necessarily act to mimic normal physiology.
In a healthy lumbar spine the axis of rotation or neutral area for motion is situated
near the inferior posterior third of the lumbar disk. A desirable artificial system
would closely approximate physiologic motion. However, to date, posterior systems
have failed to address these concerns.
[0011] Several existing patents disclose fusion devices. For example,
U.S. Patent No. 5,415,661 discloses a device that includes a curvilinear rod such that the implant supposedly
restores normal biomechanical function to the vertebrae of the spine receiving the
implant. However, the '661 patent does not disclose a device having structure other
than a curvilinear shape that has a radius of curvature of between 0 to 180 degrees.
In addition, the '661 patent does not disclose the concept of providing an anteriorly
projected pivot point that models the natural articulation of the subject vertebrae
by using a structure that provides a virtual rotation zone substantially identical
to the rotation zone provided by the patient's vertebrae. In addition, as seen in
Fig. 3 of the '661 patent, the device disclosed in the '661 patent utilizes a body
4 having a central section 10 having an anteriorly oriented position relative to its
ends 6a, 6b.
[0012] U.S. Patent No. 6,293,949 also discloses a spinal stabilization device intended for use along the cervical
vertebrae, and intended to be installed along the anterior side of the vertebrae.
[0013] U.S. Patent No. 6,440,169 discloses a device that attaches to the spinous processes of two vertebrae and has
a leaf spring that allows the device to compress and then recover spontaneously after
the stress has ceased. However, they '169 patent does not address a construct that
includes an anteriorly projected pivot point that allows the vertebrae to articulate
when the spine undergoes flexion.
[0014] US 2004002708 A1 discloses a dynamic fixation device that allows the vertebrae to which it is attached
to move in flexion within the normal physiological limits of motion, while also providing
structural support that limits the amount of translation motion beyond normal physiological
limits. The present invention includes a flexible portion and two ends that are adapted
for connection to pedicle screws. In at least one embodiment of the present invention,
the normal axis of rotation of the vertebrae is substantially duplicated by the dynamic
fixation device. The flexible portion of the dynamic fixation device can include a
geometric shape and/or a hinge portion.
[0015] In view of the above, there is a long felt but unsolved need for a method and system
that avoids the above-mentioned deficiencies of the prior art and that provides an
effective system that is relatively simple to employ and requires minimal displacement
or removal of bodily tissue.
[0016] The solution of this object is achieved by the features of the independent claims.
The dependent claims contain further preferred developments of the invention.
SUMMARY OF THE INVENTION
[0017] The present invention provides a device according to claim 1 that can be implanted
and that provides for a specified amount of forward bending motion, thereby allowing
anterior sagittal rotation between the vertebrae that receive the implant. Reference
is hereby made for the incorporation of the conventional descriptive terms of motion
and other content presented in
Clinical Anatomy of the Lumbar Spine and Sacrum by Nikolai Bogduk, third edition,
published by Churchill Livingstone, 1999. Although anterior sagittal rotation or flexion between vertebrae is normal, significant
anterior sagittal translation or sliding motion between vertebrae is not. Thus, by
allowing some amount of rotational motion while protecting against translation, the
patient's condition or injury can be protected, thus promoting the healing process,
while subsequently providing some ability to rotate one vertebra relative to an adjacent
vertebra, thereby allowing for improved spinal motion following surgery and recovery.
Accordingly, as described herein, various implants, including a number of rod configurations
having flexible portions are presented that provide a device having the ability to
elongate and bend. Thus, it is a first aspect of the present invention to provide
a device that elongates, and a second aspect of the present invention to provide a
device that bends. More particularly, the present invention is a dynamic fixation
device that includes a flexible rod portion, wherein the flexible rod portion can
include a geometric shape and/or a hinge portion. These dynamic fixation devices are
constructed of a material of an appropriate size, geometry, and having mechanical
properties such that they bend, thus allowing the vertebrae associated with the implant
to rotate relative to one another, similar to the movement of a natural spine.
[0018] A dynamic fixation device is a quasi-flexible, semi-rigid fixation construct that
allows some measure of motion between the vertebrae attached to the dynamic fixation
device. Dynamic fixation of the lumbar spine provides means of protecting lumbar structures
and allows for healing without proceeding to a lumbar arthrodesis. The constraints
on such a system are in some ways different than for a rigid or near rigid construct,
such as that used for fusion.
[0019] At the present time, pedicle fixation is an accepted method of fixing to the spine.
In the situation of a lumbar fusion, a relatively rigid construct is appropriate to
stabilize the spine and allow healing of the bony structures. In the situation of
providing protection to the lumbar structures, a flexible system is appropriate to
limit but not stop the motion of lumbar elements. The flexible elements in such a
system need to accomplish several objectives. The primary objective is to allow physiologic
motion of the spine, while protecting against excessive or non-physiologic movement.
A secondary consideration is to protect the pedicle fixation from undue stress that
could loosen the fixation at its bony interface.
[0020] The normal instantaneous axis of rotation of the lumbar spine occurs typically near
the lower posterior third of the disk. Conventional pedicle fixation of the spine
typically places the fixation rod or plate at the dorsal aspect of the apophyseal
joint or posterior to the joint. Therefore, it is appropriate to consider a construct
that effectively shifts this rotation point anteriorly toward the physiologic axis.
[0021] A group of geometries exist, which if applied to a posterior device, will constrain
the i subluxation of the segment and maintain the rotation in or close to the normal
zone or axis of rotation. The indication for use is to constrain the stresses and
motion within a range which will allow the body's normal healing response to maintain
adequate competence in the motion segment to avoid development of instability or neurologic
deficit and minimize pain or arthritis. The important features allow for maintenance
of physiologic motion without the abnormal subluxation or translation that are associated
with a degenerating disk and contribute to further degeneration. Thus, it is a separate
aspect of the invention to provide a construct that limits excessive subluxation or
translation.
[0022] Although the motion is complex related to the range of stresses which may be applied,
it is nonetheless possible to provide a device so that while in compression, movement
is axial or accompanied by slight dorsal translation, and that while in flexion allows
both separation of posterior elements and slight ventral translation allowing rotation
about the posterior portion of the disk.
[0023] Accordingly, it is an aspect of the present invention to provide a device that allows
for some limited motion, thereby decreasing the stresses placed on the various component
parts of the implant, as well as the affected vertebrae. It is a further aspect of
the present invention to provide a device whose motion is designed to model the bending
motion of the spine. Several separate embodiments of the present invention accomplish
such tasks.
[0024] It is a separate aspect of the present invention to provide a construct that geometrically
accommodates the human spinal anatomy, while providing a structural member that provides
an anteriorly projected zone of rotation.
[0025] In a first device not falling within the scope of the claims, an implantable elastomeric
material may be used, or a surgically implantable alloy can be used that includes
a geometric shape having a plurality of arms (e.g., four arms) with an interior open
region between the arms. In one example of this device, the geometric shape is rectangular,
such that the arms of the geometric shape are situated at 90 degree angles relative
to each other. Upon deformation due to flexion of the spine, the geometric shape deforms,
and the 90 degree angles between the arms change such that the geometric shape expands
and becomes a parallelogram. In a separate aspect the convergence segments of the
arms include partially circular corners. Alternatively, the partially circular corners
may be of a different shape, such as partially triangular. In a separate aspect, the
inside surface of the interior sidewalls of the arms of the geometric shape have an
interior surface that is at an angle of 90 degrees relative to a planar surface of
the geometric shape. Attached to the exterior of the geometric shape near two opposing
corners are two rod arms. The rod arms allow the device to be connected to connectors,
which interconnect the device to pedicle screws. In a separate aspect, each rod arm
may be situated at different angles and locations along the geometric shape, thereby
influencing the location of the projected pivot point in the plane of the geometric
shape upon flexion of the spine.
[0026] In yet a separate device, a dynamic fixation device utilizes at least two adjacent
geometric shapes that act in an accordion manner; however, this embodiment serves
to project the effective pivot point anterior relative to the device. Therefore, the
projected pivot point mimics the natural rotational axis of the vertebrae to which
the device is attached. In a modification, more than two adjacent geometric shapes
are combined to form the flexible portion of the device. One aspect and its modification
is that smaller geometric shapes may be used with the addition of more geometric shapes.
Consequently, a smaller profile dynamic fixation device can be provided, while at
the same time having an effective pivot point that is projected anteriorly a sufficient
distance to mimic the natural rotational axis of the vertebrae to which the device
is attached.
[0027] In yet a separate device, a dynamic fixation device is provided that includes a modified
geometric shape that serves as the flexible portion of the device. The modified geometric
shape incorporates an opening or void space that allows the device to elongate and
deform to accommodate flexion of the spine.
[0028] The dynamic fusion device can include a geometric shape with an interior hollow region,
preferably having sloped interior sidewalls. This feature allows the device to bend
in a direction transverse to the plane of the geometric shape. The angle of the interior
sidewalls can vary depending upon the desired amount of projection of the pivot point,
which acts as a virtual axis of rotation for the device.
[0029] The device of the invention includes flexible anterior-posterior segment, an anterior-posterior
segment bounded by one or more zones with joints in the rod portions.
[0030] While the dynamic fixation devices described herein act to naturally control the
axis or region of rotation within the device, it is also advantageous to consider
the disk as part of the construct. If the disk is assumed to be competent as regards
axial loads as opposed to translational loads, this competence can be used to control
the disk height and concomitantly, the anterior portion of the implant and vertebral
construct. Thus, this allows a posterior construct having a rotatable anterior-posterior
segment to effectively control translation within a specific range of motion of the
segmental construct. Although there is a slight translation allowed, this is well
within the natural region of rotation. This device preferably includes a hinged portion
having pin. If anterior-posterior segment or hinged arm is considered to be an elastomeric
segment, its function depends on the translational forces being less than required
to cause buckling of this segment. Controlling the shape of cross-section of this
segment can allow forward bending of the spine while still maintaining competence
in compression in the range of forces encountered in the implanted situation.
[0031] For the above described devices, first and second rod arms are attached to either
end of the flexible construct, with the other end of the rod arms attached to connectors,
which in turn are connected to pedicle screws that are inserted into vertebrae of
the spine. During flexion and extension each vertebra exhibits an arcuate motion in
relation to the vertebra below. The center of the arc lies below the moving vertebra.
The dynamic fusion device provides a device for allowing movement of the vertebrae,
with a forwardly or anteriorly projected pivot location that models and substantially
aligns with the actual pivot point of rotation for the vertebrae to which the device
is attached. Accordingly, the dynamic fusion device of the present invention provides
a bendable rod for fusion that mimics the movement of the vertebrae of the spine.
[0032] The dynamic portions of the present invention lengthen as they are elongated and
shorten as they compressed. This characteristic allows the devices to be implanted
in the spine with a pedicle screw system, and while the actual construct is positioned
well dorsal in the spine, it allows the spine to function as though there were a flexible
construct in the anterior column of the spine.
[0033] In use, a problematic spinal disc is initially identified by a physician. During
surgery, an incision is made through the skin and muscle overlying the implant location
of the spine. Then a first pedicle screw is inserted into a first vertebra and a second
pedicle screw is inserted into a second vertebra. The surgeon then attaches the dynamic
fixation device to the pedicle screws using either an adjustable connector or an end
connector that is integrally formed as a part of the dynamic fixation device.
[0034] Various devices have been described in this summary of the invention but such devices
are by no means to be deemed limiting to the "present invention" and the detailed
description, the figures and the claims should be referred to in there totality to
appreciate the true scope and breath of the present invention. It should be understood
that this Summary of the Invention may not contain all of the aspects of the present
invention, is not meant to be limiting or restrictive in any manner, and that the
invention as disclosed herein is and will be understood by those of ordinary skill
in the art to encompass obvious improvements and modifications thereto.
[0035] Additional advantages of the present invention will become readily apparent from
the following discussion, particularly when taken together with the accompanying drawings.
Only the device of figures 12a-12d falls within the scope of the claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0036]
Fig. 1 is a side perspective view of two vertebra in a neutral position;
Fig. 2 is a side perspective view of the two vertebra shown in Fig. 1 in a condition
of flexion;
Fig. 3a is a side elevation view of a dynamic fixation device used in conjunction
with pedicle screws;
Fig. 3b is a side perspective view of the device shown in Fig. 3a attached to two
vertebra in a neutral position;
Fig. 3c is a side perspective view of the device shown in Fig. 3a attached to two
vertebra in a flexed position;
Fig. 4a is a side elevation view of a separate dynamic fixation device used in conjunction
with pedicle screws;
Fig. 4b is a side perspective view of the device shown in Fig. 4a attached to two
vertebra in a neutral position;
Fig. 4c is a side perspective view of the device shown in Fig. 4a attached to two
vertebra in a flexed position;
Fig. 5a is a side elevation view of a modification of the dynamic fixation device
shown in Fig. 4a used in conjunction with pedicle screws;
Fig. 6a is a front perspective view of a separate dynamic fixation device;
Fig. 6b is a front elevation view of the device shown in Fig. 6a;
Fig. 6c is a rear elevation view of the device shown in Fig. 6a;
Fig 6d is a side elevation view of the device shown in Fig. 6a;
Fig. 6e is a side perspective view of the device shown in Fig. 6a attached to two
vertebra in a neutral position;
Fig. 6f is a side perspective view of the device shown in Fig. 6a attached to two
vertebra in a flexed position;
Fig.7a is a side elevation view of a separate dynamic fixation device used in conjunction
with pedicle screws;
Fig. 7b is a side perspective view of the device shown in Fig. 7a attached to two
vertebra in a neutral position;
Fig. 7c is a side perspective view of the device shown in Fig. 7a attached to two
vertebra in a flexed position;
Fig. 8a is a side elevation view of a separate dynamic fixation device used in conjunction
with pedicle screws;
Fig. 9a is a side elevation view of a separate dynamic fixation device used in conjunction
with pedicle screws;
Fig. 9b is a side perspective view of the device shown in Fig. 9a attached to two
vertebra in a neutral position;
Fig. 9c is a side perspective view of the device shown in Fig. 9a attached to two
vertebra in a flexed position;
Fig. 10a is a side elevation view of a separate dynamic fixation device used in conjunction
with pedicle screws;
Fig. 10b is a side elevation view of a portion of the device shown in Fig. 10a;
Fig. 10c is a side perspective view of the device shown in Fig. 10a attached to two
vertebra in a neutral position;
Fig. 10d is a side perspective view of the device shown in Fig. 10a attached to two
vertebra in a flexed position;
Figs. 11a-11d show another device not in accordance with the claims of the present
invention;
Figs. 12a-12d show a device in accordance with the claims of the present invention;
Figs. 13a and 13d show another device not in accordance with the present invention;
Figs. 14a-14d show another device not in accordance with the present invention; and
Figs. 15a-15c show another device not in accordance with the present invention.
[0037] The above listed drawings are not necessarily to scale. In addition, the drawings
also may be exaggerated to illustrate motion of the devices and/or to illustrate structural
detail.
DETAILED DESCRIPTION OF THE INVENTION
[0038] While the present invention will be described more fully hereinafter with reference
to the figures 12a-12d in which particular embodiments are shown, 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 this invention. Accordingly, the descriptions
which follow are to be understood as illustrative and exemplary of specific structures,
aspects and features within the broad scope of the present invention and not as limiting
of such broad scope.
[0039] As noted above, at each intervertebral joint or disc D, flexion involves a combination
of anterior sagittal rotation and a small amplitude anterior translation. The various
embodiments of the present invention allow for controlled rotation while limiting
translation within an acceptable, normal physiological range.
[0040] Referring now to Fig. 3a, a side elevation view of a first dynamic fixation device
10 is illustrated. The dynamic fixation device 10 includes a geometric shape 12 connected
to a first rod end 14 and a second rod end 16. First rod end 14 and second rod end
16 are preferably connected to connectors 18a and 18b that, in turn, are connected
to pedicle screws 20. Pedicle screws 20 are inserted into the pedicles of vertebrae
when the device is attached to the vertebrae of a patient. Connectors 18a and 18b
can be of the type that are integrally formed as part of first rod end 14 and second
rod end 16, respectively. Alternately, one or both of the connectors can be a separate
type of connector that can be selectively positioned along the length of first rod
end 14 or second rod end 16, respectively, such that first rod end 14 and second rod
end 16 are adjustable (e.g., slidably) within the connectors prior to tightening the
connectors to fixedly interconnect the device 10 to the pedicle screws 20.
[0041] Still referring to Fig. 3a, dynamic fixation device 10 is shown in a neutral position.
As noted, the dynamic fixation device 10 includes a geometric shape 12 between first
rod end 14 and second rod end 16. More specifically, dynamic fixation device 10 may
include a substantially rectangular or substantially diamond-shaped geometric shape
12 that has four arms 22a, 22b, 22c and 22d. To the interior of arms 22a, 22b, 22c,
and 22d is hollow region or opening 24. In lieu of an open space opening 24 can be
formed of and/or covered by a flexible or an elastic-type webbing material (not shown).
[0042] In a separate aspect dynamic fixation device 10, the centerline of geometric shape
12 is offset relative to the longitudinal axis of dynamic fixation device 10. More
particularly, as shown in Fig. 3a, dynamic fixation device 10 has a longitudinal axis
L-L that passes through the centerline of first rod end 14 and second rod end 16.
However, the centerline CL-CL of geometric shape 12 is offset posteriorly to the longitudinal
axis L-L of dynamic fixation device 10. This offset provides a preference for the
dynamic fixation device 10 to bend in flexion, but resist bending in extension.
[0043] It is an aspect of this device that the arms 22a, 22b, 22c, and 22d of geometric
shape 12 are situated desired angles (e.g., at approximately 90 degree angles) relative
to each other when device 10 is in the neutral position. For example, arm 22a is situated
at an angle of about 90 degrees relative to arm 22b and arm 22d. Likewise, arm 22c
is situated at an angle of about 90 degrees relative to arm 22b and arm 22d. Upon
deformation of geometric shape 12 due to flexion of the spine, geometric shape 12
deforms and the angles between the arms will change.
[0044] Still referring to Fig. 3a, in yet a separate aspect of dynamic fixation device 10
the convergence segments 26 between the arms includes reduced dimensions. More particularly,
the dimensions of arms 22a and 22b are smaller in the vicinity where arm 22a joins
arm 22b. Likewise, the dimension of arms 22b and 22c are also smaller in the vicinity
where arm 22b joins arm 22c. This is also the case for the convergence segments between
arms 22c and 22d, and between arms 22d and 22a. The decreased dimensions of the arms
22a, 22b, 22c and 22d at the convergence segments 26 allow additional flexibility
between the arms. As shown in Fig. 3a, the convergence segments 26 include partially
circular corners between the arms. Alternatively, the partially circular corners may
be of a different shape, such as partially triangular (not shown). Thus, dynamic fixation
device 10 preferably includes narrowing or thinning of the arms in the vicinity of
the convergence segments 26. It is to be further noted that convergence segments 26
serve as elastomeric hinges for geometric shape 12.
[0045] As shown in the example illustrated in Figs. 3b and 3c, first rod end 14 is shown
to remain essentially immobile. Second rod end 16 moves between a neutral or first
position 28, as shown in Fig. 3b, and a flexed or second position 30, as shown in
Fig. 3c. In moving between first position 28 and second position 30 dynamic fixation
device 10 elongates and it also rotates about an effective pivot point 32. The geometric
shape 12 provides an effective pivot point 32 that is forward or anterior of the longitudinal
axis L-L of first rod end 14 and second rod end 16. During movement between first
position 28 and second position 30, dynamic fixation device 10 experiences deformation,
whereby it bends and it elongates.
[0046] In use, a surgeon first makes an incision and then inserts pedicle screws 20. Subsequently,
first rod end 14 and second rod end 16 of dynamic fixation device 10 are preferably
interconnected using connectors 18a and 18b to pedicle screws 20 that are inserted
into vertebrae V
1 and V
2 of the spine. During flexion and extension, each vertebra exhibits an arcuate motion
in relation to the vertebra below. The center of the arc lies below the moving vertebra.
Dynamic fixation device 10 provides a device for allowing movement of the upper vertebra
V
1 to a flexed or second position 30, with a forwardly or anteriorly projected pivot
location 32, as compared to the location of the longitudinal axis L-L of the device
10 when it is in the neutral position.
[0047] In a modification of the device shown in Figs. 3a, the geometric shape 12 can be
subdivided into four smaller rectangles (not shown) as opposed to one large rectangle.
This modification of using four smaller rectangles to form a geometric shape still
acts as a larger rectangle in terms of its effective pivot point. In yet an alternate
modification of this device, geometric shape 12 can take the form of a rhomboid (not
shown). In this modification, an effective pivot point would be projected forward
(or anterior) some distance of the dynamic fixation device. Accordingly, depending
upon its construction, the geometric shape 12 allows the pivot point to extend beyond
the limits of the device. When the dynamic fixation device 10 is implanted posterior
the spinal vertebrae, the device nonetheless allows for a rotation point substantially
anterior the device. Thus, depending upon the geometry of the dynamic fixation device,
and more particularly, the geometry of geometric shape 12, the present device allows
an effective pivot point 32 to be created that substantially corresponds to the natural
pivot point of the patient's spine.
[0048] Referring now to Fig. 4a, a side elevation view of a separate dynamic fixation device
34 is shown. The dynamic fixation device 34 of Fig. 4a utilizes two adjacent but connected
substantially geometric shapes 36a and 36b. Substantially geometric shapes 36a and
36b act as two accordion shapes that expand and flexibly bend forward as dynamic fixation
device 34 is elongated and rotated during bending of the spine. Arrow A depicts the
general direction of motion of second rod end 16 during rotation and elongation of
the dynamic fixation device 34.
[0049] Still referring to Fig. 4a, in one preferred embodiment, substantially geometric
shapes 36a and 36b include a plurality of arms. Substantially geometric shape 36a
includes an anterior arm 38a and a posterior arm 40a. Similarly, substantially geometric
shape 36b includes an anterior arm 38b and a posterior arm 40b. Preferably, anterior
arm 38a interconnects to posterior arm 40b by crossing arm 42. Similarly, anterior
arm 38b interconnects to posterior arm 40a by crossing arm 44. Although not required,
crossing arm 42 can be hingedly connected to crossing arm 44 using a pin 46 positioned
along crossing arm 42 and crossing arm 44. As with dynamic fixation device 10 described
above, narrowing or thinning of the arms in the vicinity of the convergence segments
26 is preferred. An opening 24a exists between crossing arm 42, anterior arm 38a and
posterior arm 40a of substantially geometric shape 36a, and another opening 24b exists
between crossing arm 44, anterior arm 38b and posterior arm 40b. In lieu of an open
space, openings 24a and 24b can be formed of a flexible or an elastic-type webbing
material (not shown).
[0050] Figs. 4b and 4c show dynamic fixation device 34 in its neutral and flexed positions,
respectively. The effect of the substantially geometric shapes 36a and 36b is to produce
an anteriorly projected effective pivot point 32 that substantially matches the rotational
point of the vertebrae to which it is attached. Thus, the device of Fig. 4a-4c substantially
limits translational displacement of the vertebrae to which it is attached, while
still allowing some amount of flexion. In general, the bending occurring with flexion
is equal to the angle change between anterior arm 38a and anterior arm 38b as the
construct elongates. Preferably, there is a rigid connection between first rod end
14 and anterior arm 38a, as well as a rigid connection between second rod arm 16 and
anterior arm 38b.
[0051] In a separate aspect dynamic fixation device 34, the centerline of substantially
geometric shapes 36a and 36b is offset posteriorly relative to the longitudinal axis
of dynamic fixation device 34. More particularly, as shown in Fig. 4a, dynamic fixation
device 34 has a longitudinal axis L-L that passes through the centerline of first
rod end 14 and second rod end 16. However, the centerline CL-CL of substantially geometric
shape 36a and 36b is offset posteriorly to the longitudinal axis L-L of dynamic fixation
device 34. This offset provides a natural fixation for the first rod end 14 to be
a continuation of anterior arm 38a, and for second rod end 16 to be a continuation
of anterior arm 38b.
[0052] Referring now to Fig. 5a, in a modification of the device shown in Fig. 4a, more
than two substantially geometric shapes may be incorporated into a dynamic fixation
device 34'. More particularly, the dynamic fixation device 34 having substantially
geometric shapes 36a and 36b may be modified to include a third, fourth, fifth, or
any number of additional substantially geometric shapes. For example, substantially
geometric shapes 36a and 36b of the device shown in Figs. 4a illustrate two substantially
diamond shaped features, respectively. However, as shown in Fig. 5a, a third substantially
diamond shape 36c may be added to geometric shape 36a and 36b. Optional pins 46 may
be used between the various substantially geometric shapes. Alternatively, four (not
shown), five (not shown) or more geometric shapes may be grouped together to form
a dynamic fixation device. Multiple substantially geometric shapes may differ in size
and/or overall shaped configuration, which may be desirous depending upon the number
used. For example, where three substantially geometric shapes 36a, 36b and 36c are
used, as in dynamic fixation device 34', the overall size of each geometric shape
is preferably smaller than the two substantially geometric shapes 36a and 36b illustrated
in dynamic fixation device 34, as shown in Fig. 4a. The, addition of added substantially
geometric shapes projects the pivot pint 32 proportionally forward for the number
of substantially geometric shapes used.
[0053] Referring now to Figs. 6a-6f, in yet a separate device, a dynamic fixation device
50 includes geometric shape 12 with an interior hollow region 24, wherein device 50
bends in a direction transverse to the planar surface 52 of geometric shape 12. The
interior hollow region 24 preferably includes sloped interior surface 54. That is,
the interior sidewalls 56 have an interior surface 54 that is at an angle θ with the
planar surface 52 of geometric shape 12. Angle θ of interior surface 54 can be one
constant value, or it can vary within the device. By way of a non-limiting example,
θ can be 60 degrees at the top of device 50, and vary to about 90 degrees at the bottom
of device 50.
[0054] Referring now to Figs. 6a-6c, interior hollow region 24 preferably includes four
partially circular corners or convergence segments 26. Attached to two opposing partially
circular corners or convergence segments 26 are first rod end 14 and second rod end
16. Each rod end 14 and 16 is situated at an angle of about 135 degrees from each
adjacent side of the geometric shape 12. However, in an alternate aspect of this device,
the rod ends 14 and 16 may be situated at different angles relative to the arms of
the geometric shape 12. As with device 10, partially circular corners or convergence
segments 26 may be of a different shape, such as partially triangular. Equivalently,
a mechanical hinge rather than an elastomeric hinge may be incorporated at convergence
segments 26.
[0055] As shown in Fig. 6d, pedicle screws 20 are orientated perpendicular to the planar
surface 52 of geometric shape 12. Connectors 18a and 18b are used to attach the pedicle
screws 20 to first and second rod ends 14 and 16 of dynamic fixation device 50. The
connectors 18a, 18b may be formed as an integral part of dynamic fixation device 50,
or the connectors 18a, 18b may be a separate device, as is known to those knowledgeable
in the art. In use, the dynamic fixation device 50 expands as it rotates and/or bends
when attached to two vertebra that undergo flexion.
[0056] Referring now to Figs. 7a-7c, yet a separate dynamic fixation device is shown. Dynamic
fixation device 58 includes four substantially straight and rigid arm segments. These
consist of lower arm 60a, first middle arm 60b, second middle arm 60c, and upper arm
60d. Lower arm 60a and upper arm 60d connect to connectors 18a and 18b, respectively,
which are then connected to pedicle screws 20. Using pins 46, lower arm 60a is hingedly
connected to one end of middle arms 60b and 60c. Upper arm 60d is hingedly connected
using pins 46 to the opposite end of middle arms 60b and 60c. Between the four hinge
points is an opening 24 that is a quadrilateral shape. During flexion, upper arm 60d
moves upward and forward, thereby forcing middle arms 60b and 60c to rotate downward.
Thus, the hinged connection of middle arms 60b and 60c to upper arm 60d allows it
to move forward, while the connection of middle arms 60b and 60c to lower arm 60a
prevents excessive translation or over-rotation. Dynamic fixation device 58 allows
for the upper vertebra to move up and forward, yet resists excessive translation of
the vertebrae to which it is attached.
[0057] Referring now to Fig. 8a, yet a separate dynamic fixation device is shown. The dynamic
fixation device 62 shown in Fig. 8a is a dynamic fixation device that features an
anterior-posterior segment 64. The dynamic fixation device 62 includes a first rod
end 14 having a rod arm 65 that extends at an angle α toward an anterior-posterior
segment 64. Angle α is fixed in relation to pedicle screw 20 by the rigid connection
between rod arm 65 and lower pedicle screw 20. Similarly, rod arm 73 is fixed by a
rigid connection to the upper pedicle screw 20. Rod arm 65 of first rod end 14 is
connected to anterior-posterior segment 64 at bend 66. More particularly, bend 66
forming the connection between rod arm 65 and anterior-posterior segment 64 can be
a continuous structural piece such that rod arm 65 and anterior-posterior segment
64 are essentially a contiguous solid piece including bend 66. Alternatively, bend
66 may be a hinged connection with a pin that interconnects rod arm 65 to anterior-posterior
segment 64. Anterior-posterior segment 64 is separated from rod arm 65 by angle β.
[0058] Still referring to Fig. 8a, at bend 66, anterior-posterior segment 64 extends posteriorly
to bend 68. Middle rod segment 70 extends from bend 68 at the posterior end of anterior-posterior
segment 64 to bend 72 that forms the connection to rod arm 73 of second rod end 16.
Bend 72 forms the intersection and the connection between middle rod segment 70 and
rod arm 73. Bend 72 can be a continuous structural piece such that middle rod segment
70 and rod arm 73 are essentially a contiguous solid piece including bend 72, or bend
72 can be a connection that interconnects middle rod segment 70 and rod arm 73. The
middle rod segment 70 is separated from the anterior-posterior segment 64 by angle
φ.
[0059] First rod end 14 and second rod end 16 preferably are interconnected to pedicle screws
20 using connectors 18a and 18b, respectively. Connectors 18a and 18b can be formed
as an integral part of the end of dynamic fixation device 62, or they can be separate
devices, as is known to those knowledgeable in the art.
[0060] Still referring to the device shown in Fig. 8a, dynamic fixation device 62 also has
a longitudinal axis L-L that is defined by the center of connectors 18a and 18b. Rod
arm 65 generally lies anterior of longitudinal axis L-L, and middle rod segment 70
generally lies posterior of longitudinal axis L-L, with anterior-posterior segment
64 having portions both on the anterior and posterior sides of longitudinal axis L-L.
[0061] It is an aspect of the present device that bend 68 preferably acts as a hinge and
is able to move down if the vertebrae to which the dynamic fixation device 62 is attached
is placed in compression. In addition, bend 68 can move up to accommodate flexion
of the vertebrae. This motion of bend 68 and the anterior-posterior segment 64 closely
approximates the normal arc of motion of human vertebra. When in compression, bend
68 moves down along a lower arc path 74. Lower arc path 74 is caused when dynamic
fixation device 62 is placed in compression and anterior-posterior segment 64 moves
toward rod arm 65, thereby decreasing the angle β. In a typical human patient, angle
β may decrease up to 30 degrees as bend 68 passes along lower arc path 74. To achieve
this motion, bend 68 of dynamic fixation device 62 preferably includes a structure
to allow it to act as a hinge. Accordingly, bend 68 may include a pin 75. As illustrated
in Fig. 8a, pin 75 is shown in the neutral position. However, in the compressed position,
pin 75' is shown in its lower position. When the vertebrae undergo flexion, bend 68
moves up along an upper arc path 76. Upper arc path 76 is caused when dynamic fixation
device 62 elongates and anterior-posterior segment 64 moves upward, thereby increasing
the angle β. In a typical human implant, angle β may increase up to 30 degrees as
bend 68 passes along upper arc path 76. For at least some patients, the neutral position
for anterior-posterior segment 64 will be slanted downward from horizontal, with bend
68 positioned lower than bend 66. Thus, angle β would have a lesser amount of allowable
compression over flexion extension. In the elongation condition, pin 75" is shown
in its upper position. In compression, angle φ will decrease, and when the dynamic
fixation device elongates during flexion, angle φ will increase.
[0062] The various devices described herein allow a slight amount of translational motion
of the vertebrae, but the amount of translational motion allowed is within the physiological
limits of normal motion of the human vertebrae. For example, for the device shown
in Fig. 8a, as pin 75 moves forward along lower arc path 74 and upper arc path 76,
the vertebrae will undergo a slight amount of translational movement, as is evidenced
by the position of pin 75' and 75", which are moved slightly anterior or forward from
the neutral position.
[0063] Referring now to Fig. 9a-9c, yet a separate embodiment of a dynamic fixation device
is shown. Dynamic fixation device 78 includes three substantially straight arm segments.
These consist of lower arm 80a, first middle arm 80b, and upper arm 80c. Lower arm
80a and upper arm 80c connect to connectors 18a and 18b, respectively, which are then
connected to pedicle screws 20. Using a pin 46, lower arm 80a is hingedly connected
to one end of middle arm 80b. The opposite end of middle arm 80b is hingedly connected
(e.g., by a pin 46) to upper arm 80c. During flexion, upper arm 80c moves upward and
forward, thereby forcing middle arm 80b to rotate downward. Thus, the hinged connection
of middle arm 80b to upper arm 80c allow it to upward with forward rotation, while
the connection between middle arm 80b and lower arm 80a prevents excessive translation
or over-rotation. Similar to function of the anterior-posterior segment 64 in device
62, middle arm 80b acts as an anterior-posterior segment that allows a range of motion
in flexion, yet prevents the vertebrae from experiencing excessive translation. Thus,
dynamic fixation device 78 allows for the upper vertebra to move up and slightly forward,
yet resists excessive translation of the vertebrae to which it is attached.
[0064] Referring now to Figs. 10a, yet a separate dynamic fixation device is illustrated.
Dynamic fixation device 82 includes a first rod member 84 connected to a first rod
end 14 and a second rod member 86 connected to a second rod end 16, wherein the first
rod end 14 and the second rod end 16 are interconnected to pedicle screws 20 using
connectors 18a and 18b, respectively. First rod member 84 and second rod member 86
anteriorly and posteriorly confine a spring 88. In addition, rails 90 confine spring
88 on the lateral sides, and rails 90 also serve to interconnect first rod member
84 to second rod member 86. The structure of dynamic fixation device 82 provides for
an articulated device that can also elongate, thus accommodating the natural physiologic
motion of two adjacent vertebra when undergoing flexion. The structure and function
of these components will be described in detail below.
[0065] Still referring to Fig. 10a, first rod member 84 preferably includes a concave surface
92 along its posterior side, wherein the concave surface 92 of first rod member 84
assists in providing anterior confinement of spring 88. Second rod member 86 preferably
includes a concave surface 94 along its anterior side, wherein the concave surface
94 of second rod member 86 assists in providing posterior confinement of spring 88.
[0066] As noted above, rails 90 (shown in dashed lines) interconnect the first rod member
84 to second rod member 86. Preferably, rails 90 comprise a plate 96 with hinge pins
46 situated through both ends of the plate 96. Plate 96 is shown in Fig. 10b. In one
preferred device, first rod member 84 includes a first notch 98 for receiving a first
hinge pin 46. Similarly, second rod member 86 includes a second notch 98 receiving
a second hinge pin 46. Plates 96 span the confinement zone 100 of spring 88 and interconnect
first rod member 84 and second rod member 86 while laterally containing spring 88
between rod members 84 and 86 and preventing the spring 88 for moving outside of the
confinement zone 100. In a separate aspect, rails 90 may be formed using a single
piece. That is, the plate 96 and hinge pin 46 construction may be machined or otherwise
constructed of a single piece.
[0067] By way of example and not limitation, preferably spring 88 is a cylindrical shaped
spring having a proper spring constant for the dynamic fixation device 82. In addition,
spring 88 may also take the form of a resilient material, such as a properly sized
silicone insert shaped, for example, as a disc or a sphere. During flexion motion
of the spine, second rod member 86 moves up and forward. During this movement, the
spring 88 rolls between the first rod member 84 and the second rod member 86. Since
the spring 88 rolls, friction between first rod member 84 and second rod member 86
is minimal. Thus, the ability of the spring to roll can be modified by adjusting the
shape of the spring and the shape and texture of the interior walls of the confinement
zone 100. More particularly, the shape and surface texture of concave surfaces 92
and 94 of the first and second rod members 84 and 86, respectively, can be modified
to adjust the magnitude and ease of motion in elongation of the second rod member
86 relative to the first rod member 84. Since the spring 88 is cable of being compressed,
it deforms, thereby allowing bending. The amount of compression is controlled by the
spring characteristics, such as the spring material type, diameter and wall thickness,
as well as the shape of the confinement zone 100 and the texture of the concave surfaces
92 and 94. With regard to the shape of the confinement zone 100, the concave surfaces
92 and 94 serve as the compression surfaces of the confinement zone 100 for spring
88. The shape of the curves of the concave surfaces 92 and 94 can be altered to control
the degree of spring compression as the construct elongates. For example, referring
to Fig. 10a, the curvature of concave surfaces 92 and 94 can be flattened, thereby
influencing the reaction of the spring 88 within the confinement zone 100 during flexion
extension.
[0068] Referring now to Figs. 10c and 10d, dynamic fixation device 82 is shown both in its
neutral position and it the flexed position, respectively. For purposes of clarity,
the rails 90 are dashed in Figs. 10c and 10d. As compared to the neutral position
shown in Fig. 10c, the elongated position of Fig.10d illustrates that spring 88 has
rolled up and is also slightly compressed. The characteristics of the spring 88 are
chosen such that some desired amount of compression of the spring is allowed during
flexion; however, the spring 88 is stiff enough such that unwanted amounts of translation
of the vertebrae are resisted.
[0069] Dynamic fixation device 82 is allowed to elongate because second rod member 86 is
hingedly attached to first rod member 84, thereby allowing vertical motion of second
rod member 86 relative to first rod member 84. Thus, the structure of dynamic fixation
device 82 provides for an articulated device that can elongate, thus accommodating
the natural physiologic motion of the spine.
[0070] Dynamic fixation device 82 has application to providing segmentally applied motion
control of the spine because each motion segment designated to receive an implant
can have a dynamic fixation device implant customized through its dimensions and spring
constant, thereby giving the patient controlled motion within a desired normal physiologic
range.
[0071] In a typical use to span two vertebra, the total length of the dynamic fixation devices
10, 34, 34', 50, 58, 62, 78, and 82 may be approximately 15 to 35mm. The geometric
shape portions or hinge structures of the dynamic fixation devices, preferably occupy
the central region of the implant that bridges two vertebra. That is, the geometric
shapes or hinge structures occupy only a portion of the implant, thereby allowing
first rod end 14 and second rod end 16 to be solid rod segments that can be interconnected
to a pedicle screw using a connector device. For those devices comprising a geometric
shape or hinged structure, these structures will typically occupy approximately 15
to 20mm of the total length.
[0072] Referring now to Figs. 11a-11d, a dynamic fixation device 102 is shown. The device
includes an anterior-posterior segment 104 containing a contoured shape 106 aligned
transverse to the spine and/or substantially in an anterior-posterior orientation
relative to the spine. The anterior-posterior segment 104 can bend relatively easier
in one direction (flexion) than the other (extension). Additionally; the anterior-posterior
segment 104 resists motion in the plane of the segment, which corresponds to resisting
translational movement. Thus, the dynamic fixation device 102 accommodates at least
some rotation of the vertebrae in flexion, while also resisting translation of the
vertebrae.
[0073] The anterior-posterior segment 104 may have an anterior-posterior dimension of about
20mm and a lateral width of about 10mm; however, dimensions of the anterior-posterior
segment are anticipated to vary depending upon a number of factors, including the
amount of desired movement, the size of the patient that is the recipient of the implant,
and the dimensions and material types used to the construct the device. The dynamic
fixation device 102 provides on the order of approximately ten degrees of rotation
in flexion and on the order of approximately negative two degrees of rotation in the
extension.
[0074] Referring now to Fig. 11a, a dynamic fixation device 102 featuring an anterior-posterior
segment 104 containing a contoured shape 106 is generally shown. The contoured shape
106 allows the dynamic fixation device 102 to rotate around the effective pivot point
32 when the device 102 is elongated in flexion. The dynamic fixation device 102 includes
a first rod member 108 connected to or integral with a first rod end 14 and a second
rod member 110 connected to or integral with a second rod end 16, wherein the first
rod end 14 and the second rod end 16 are interconnected to pedicle screws 20 using
connectors 18a and 18b, respectively. The first rod member 108 and second rod member
110 anteriorly and posteriorly attach to or are integral with the anterior-posterior
segment 104. The attachments, interconnections or joining portions between the anterior-posterior
segment 104 and the rod members 108 and 110 may comprise a flexible connection, such
as a living hinge or a pinned connection.
[0075] At least portions of the dynamic fixation device 102 may be made from one or more
materials that possess the appropriate strength characteristics necessary to withstand
loading from the human body when used in medical applications. In addition, the materials
may be chosen to provide desired flexibility characteristics. Examples of materials
that may be used to make at least portions of the dynamic fixation device 102 include,
but are not necessarily limited to, polyether ether plastics, such as ketone (PEEK),
polyether ketone ketone (PEKK), ultra high molecular weight polyethylene (UHMWPE),
and polymethylmethacrylate (PMMA); metals, such as titanium and stainless steel; composites;
as well as other tissue compatible materials.
[0076] Still referring to the example of Fig. 11a, dynamic fixation device 102 also has
a longitudinal axis L-L that is defined by the center of connectors 18a and 18b. Rod
member 108 generally lies anterior of longitudinal axis L-L, and rod member 110 generally
lies substantially at or posterior of longitudinal axis L-L. The anterior-posterior
segment 104 has portions on both the anterior and posterior sides of longitudinal
axis L-L. Additionally, the body of the patient in which the dynamic fixation device
102 is to be implanted defines a superior and inferior direction. More particularly,
upwards or toward the patient's head is defined as the superior direction and downwards
or toward the patient's feet is described as the inferior direction. The rod member
108 is oriented in the inferior direction, and the rod member 110 is oriented in the
superior direction.
[0077] Referring now to Fig. 11b, an enlarged view of the anterior-posterior segment is
shown. The anterior-posterior segment 104 includes a contoured shape 106 to assist
in allowing motion in one direction versus the other, wherein the contours may comprise
shapes such as one or more dimples 112. In the device shown in Fig. 11b, the anterior-posterior
segment 104 features a first dimple 112a that lies substantially posterior of longitudinal
axis L-L, or at least posterior of a second dimple 112b. In addition, in the device
shown in Fig. 11b, the second dimple 112b lies substantially anterior of longitudinal
axis L-L. The first dimple 112a comprises a concave surface oriented such that the
concavity faces in the inferior direction. The second dimple 112b comprises a concave
surface oriented such that the concavity faces in the superior direction. Alternatively,
the interior-posterior segment 104 may comprise shapes other than dimples 112. For
example, contoured shape 106 may comprise oval-shaped features having concavity in
a plurality of orientations, such as the superior and inferior directions. Other shaped
anterior-posterior segments 104 are also possible. The anterior-posterior segment
104 including dimples 112 are made from a material that allows a desired amount of
bending. The countered shape 106 with its dimples allows bending at specific locations
to occur preferentially in one direction rather than another. In particular, the dimples
112 have a low resistance to bending toward the curve and a high resistance to bending
against the curve. As shown in the example illustrated in Figs. 11c and 11d, first
rod end 14 is shown to remain essentially immobile. Second rod end 16 moves between
a neutral or first position 114, as shown in Fig. 11c, and a flexed or second position
116, as shown in Fig. 11d. In moving between first position 114 and second position
116, dynamic fixation device 102 elongates or accommodates elongation, and it also
rotates about a physiologic zone of rotation or an effective pivot point 32. The countered
shape 106 thus provides an effective pivot point 32 that is forward or anterior of
the longitudinal axis L-L. During movement between first position 114 and second position
116, dynamic fixation device 102 experiences deformation, whereby it bends and it
elongates to accommodate at least some motion in flexion of the vertebrae to which
it is attached. The effective pivot point 32 is provided by the geometry of the device
102, including the motion of the countered shape 106 during both flexion and extension
of the spine. The motion of the spine shown in Fig. 11d is toward the curvature of
dimple 112b and against the curvature of dimple 112a. Accordingly, dimple 112b provides
a lower resistance to the motion and dimple 112a provides a higher resistance to the
motion. This response of the contoured shape 106 allows a point, located approximately
at the center of the anterior-posterior segment 104 to approximately travel along
the path 113 shown in Fig. 11a and to rotate about the effective pivot point 32. A
similar movement occurs during extension of the spine, wherein the dynamic fixation
device 102 becomes compressed slightly. This motion is against the curvature of dimple
112b and towards the curvature of dimple 112a. Accordingly, dimple 112b provides a
higher resistance to the motion and dimple 112a provides a lower resistance to the
motion. This motion of the anterior-posterior 104 segment allows the dynamic fixation
device 102 to move in a way that closely approximates the normal physiologic motion
ofthe human vertebrae. Referring now to Figs. 12a-12d, a dynamic fixation device 118
in accordance with the present invention is shown. The device includes flexible rod
members 120 and 122, and an anterior-posterior segment 124 aligned transverse to the
spine and/or substantially in an anterior-posterior orientation relative to the spine.
The dynamic fixation device 118 can bend relatively easier in one direction (flexion)
than the other (extension). Additionally, the dynamic fixation device 118 resists
motion in the plane of the segment, which corresponds to resisting translational movement.
Thus, the dynamic fixation device 118 accommodates at least some rotation of the vertebrae
in flexion, while also resisting translation of the vertebrae.
[0078] The anterior-posterior segment 124 may have an anterior-posterior dimension of about
20mm and a lateral width of about 10mm; however, dimensions of the anterior-posterior
segment are anticipated to vary depending upon a number of factors, including the
amount of desired movement, the size of the patient that is the recipient of the implant,
and the dimensions and material types used to the construct the device. In accordance
with embodiments of the present invention, the dynamic fixation device 118 provides
on the order of approximately ten degrees of rotation in flexion and on the order
of approximately negative two degrees of rotation in the extension.
[0079] Referring now to Fig. 12a, a dynamic fixation device 118 featuring a first flexible
rod member 120, a second flexible rod member 122 and an anterior-posterior segment
124 is generally shown. The flexible rod members 120 and 122 allow the dynamic fixation
device 118 to rotate around the effective pivot point 32 when the device 118 is extended
in flexion. The first flexible rod member 120 is connected to a first rod end 14 which,
in turn, is connected to pedicle screw 20 by means of connector 18a. The second flexible
rod member 122 is connected to a second rod end 16 which, in turn, is connected to
pedicle screw 20 by means of connecter 18b. The first rod member 120 and the second
rod member 122, respectively, attach anteriorly and posteriorly to the anterior-posterior
segment 124. In accordance with at least one embodiment of the invention, the attachments,
interconnections or joining portions between the anterior-posterior segment 124 and
the rod members 120 and 122 may comprise a flexible connection, such as a living hinge
or a pinned connection.
[0080] At least portions of the dynamic fixation device 118 may be made from one or more
materials that possess the appropriate strength characteristics necessary to withstand
loading from the human body when used in medical applications. In addition, the materials
may be chosen to provide desired flexibility characteristics. In accordance with embodiments
of the present invention, examples of materials that may be used to make at least
portions of the dynamic fixation device 118 include, but are not necessarily limited
to, polyether ether plastics, such as ketone (PEEK), polyether ketone ketone (PEKK),
ultra high molecular weight polyethylene (UHMWPE), and polymethylmethacrylate (PMMA);
metals, such as titanium and stainless steel; composites; as well as other tissue
compatible materials.
[0081] Still referring to the example of the present embodiment shown in Fig. 12a, dynamic
fixation device 118 also has a longitudinal axis L-L that is defined by the center
of connectors 18a and 18b. Rod member 120 generally lies anterior of longitudinal
axis L-L, and rod member 122 generally lies substantially at or posterior of longitudinal
axis L-L. In accordance with at least one embodiment of the present invention, the
anterior-posterior segment 124 has portions on both the anterior and posterior sides
of longitudinal axis L-L. Flexible rod members 120 and 122 are provided with joints
that allow the rod members to bend. Fig. 12a shows joint 126a of rod member 120, as
well as joint 126b of rod member 122. In order to more clearly explain the function
of the joints, the following discussion refers to joint 126a of rod member 120. As
can be appreciated, joint 126b of rod member 122 functions in a similar manner. Joint
126a connects inferior flexible rod portion 120a and superior flexible rod portion
120b. Joint 126a allows bending of the flexible rod member 120 through the angle λ,
which is defined between the inferior flexible rod portion 120a and the anterior-posterior
segment 124. Similarly angle µ defines a range of motion for joint 126b.
[0082] Fig. 12b shows a detailed view of the joint 126a of the flexible rod member 120.
In accordance with at least one embodiment of the present invention, joint 126a is
comprised of segment 128 axially bordered by two segments 130. The segments 130 comprise
a series of recessed portions 132. In accordance with at least one embodiment of the
present invention, the recessed portions 132 are oriented with respect to either the
anterior side of the rod member 120 or with respect to the posterior side of the of
the rod member 120. Thus, the modified segment 130 comprises a series of recessed
portions 132 that alternate between posteriorly oriented recessed portions 132a and
anteriorly oriented recessed portions 132b. The recessed portions 132 can be made
using techniques known in the art, such as by use of example, removal of material,
making cuts in the rod or forming the recessed portions 132 by injection molding.
In addition, other structures for providing flexibility at joints 126a and 126b are
within the scope of the invention, such as thinned sections, crescent-shaped segments,
etc.
[0083] As shown in the example illustrated in Figs. 12c and 12d, first rod end 14 is shown
to remain essentially immobile. Second rod end 16 moves between a neutral or first
position 134, as shown in Fig. 12c, and a flexed or second position 136, as shown
in Fig. 12d. In moving between first position 134 and second position 136, dynamic
fixation device 118 elongates and it also rotates about a physiologic zone of rotation
or an effective pivot point 32. The flexible rod members 120 and 122 with one or more
joints 126a and 126b, together with the anterior-posterior segment 124 provide an
effective pivot point 32 that is forward or anterior of the longitudinal axis L-L.
During movement between first position 134 and second position 136, dynamic fixation
device 118 experiences deformation, whereby it bends and it elongates to accommodate
at least some motion in flexion of the vertebrae to which it is attached. The effective
pivot point 32 is provided by the geometry of the device 118, including the bending
of joints 126a and 126b. As the dynamic fixation device 118 elongates, joint 126a
bends such that the angle λ is increased. Likewise j oint 126b bends such that the
angle µ is increased. This allows the device to bend as shown in Fig. 12d. As the
joints 126a and 126b bend, the dynamic fixation 118 device is allowed to rotate about
the effective pivot point 32. This motion allows the dynamic fixation device 118 to
move in way that closely approximates the normal motion of the human vertebrae.
[0084] Referring now to Figs. 13a-13d, a dynamic fixation device 136 is shown. The device
includes a partially folded rod segment 138. The partially folded segment 138 can
bend relatively easier in one direction (flexion) than the other (extension). Additionally,
partially folded segment 138 resists motion in the plane of the segment, which corresponds
to resisting translational movement. Thus, the dynamic fixation device 136 accommodates
at least some rotation of the vertebrae in flexion, while also resisting translation
of the vertebrae.
[0085] The partially folded segment 138 may have an anterior-posterior dimension of about
20mm; however, dimensions of the partially folded segment 138 are anticipated to vary
depending upon a number of factors, including the amount of desired movement, the
size of the patient that is the recipient of the implant, and the dimensions and material
types used to the construct the device. The dynamic fixation device 136 provides on
the order of approximately ten degrees of rotation in flexion and on the order of
approximately negative two degrees of rotation in the extension.
[0086] Referring now to Fig. 13a, a dynamic fixation device 136 featuring a partially folded
segment 138 is generally shown. The partially folded segment 138 allows dynamic fixation
device 136 to rotate around the effective pivot point 32 when the device 136 is elongated
in flexion. This folded segment is attached to a first rod end 14 and a second rod
end 16. The first and second rod ends 14 and 16 are, in turn, connected to pedicle
screws 20 by means of connecters 18a and 18b, respectively. The dynamic fixation device
136 also has a longitudinal axis L-L that is defined by the center of connectors 18a
and 18b.
[0087] At least portions of the dynamic fixation device 136 may be made from one or more
materials that possess the appropriate strength characteristics necessary to withstand
loading from the human body when used in medical applications. In addition, the materials
may be chosen to provide desired flexibility characteristics. In accordance with embodiments
ofthe present invention, examples of materials that may be used to make at least portions
of the dynamic fixation device 136 include, but are not necessarily limited to, polyether
ether plastics, such as polyether ether ketone (PEEK), polyether ketone ketone (PEKK),
ultra high molecular weight polyethylene (UHMWPE), and polymethylmethacrylate (PMMA);
metals, such as titanium and stainless steel; composites; as well as other tissue
compatible materials.
[0088] Still referring to the example of Fig. 13a, the partially folded segment 138 comprises
a series of substantially planar segments 140. The partially folded segment 138 may
be made of interconnected elements or, alternatively, machined out of a single piece
of material. Flexible joints, such as living hinges 141, connect adjacent planar segments
140. The planar segments 140 have a quadrilateral shape. Each planar segment has two
sides 142a and 142b oriented substantially in an anterior-posterior direction and
two sides 144a and 144b oriented substantially in a superior-inferior direction. The
length of side 144a, located posterior of longitudinal axis L-L, is longer than the
length of side 144b, located anterior of longitudinal axis L-L. This difference in
length allows the folded segment 138 to unfold in a manner resembling that of a Japanese
fan. Fig.13b shows close-up view of the folded segment 138 viewed from in the posterior
to anterior direction.
[0089] As shown in the example illustrated in Figs. 13c and 13d, first rod end 14 is shown
to remain essentially immobile. Second rod end 16 moves between a neutral or first
position 146, as shown in Fig. 13c, and a flexed or second position 148, as shown
in Fig. 13d. In moving between first position 146 and second position 148, dynamic
fixation device 136 elongates or accommodates elongation, and it also rotates about
a physiologic zone of rotation or an effective pivot point 32. The partially folded
segment 138 thus provides an effective pivot point 32 that is forward or anterior
of the longitudinal axis L-L. During movement between first position 146 and second
position 148, dynamic fixation device 136 experiences deformation, whereby it bends
and it elongates to accommodate at least some motion in flexion of the vertebrae to
which it is attached.
[0090] The folded segment 138 allows the dynamic fixation device 136 to elongate and rotate
about an effective pivot point 32. As shown in Fig. 13a and 13b, the planar segments
140 are all angled in a direction towards the spine. In particular, the planar segments
140 are all oriented on lines that converge at a point anterior of the dynamic fixation
device 136. This point provides the approximate location of the effective pivot point
of the dynamic fixation device 136. As the dynamic fixation device 136 elongates,
folded segment 138 unfolds enabling rotation about the effective pivot point 32. This
allow the device to bend as shown in Fig. 13d. This motion allows the dynamic fixation
device 118 to move in way that closely approximates the normal motion of the human
vertebrae in flexion, while also resisting physiologically abnormal amounts of movement
in translation.
[0091] Referring now to Figs. 14a-14d, a dynamic fixation device 150 is shown. The device
includes a partially folded rod segment 152. The partially folded segment 152 can
bend relatively easier in one direction (flexion) than the other (extension). Additionally,
partially folded segment 152 resists motion in the plane of the segment, which corresponds
to resisting translational movement. Thus, the dynamic fixation device 150 accommodates
at least some rotation of the vertebrae in flexion, while also resisting translation
of the vertebrae.
[0092] The partially folded segment 152 may have an anterior-posterior dimension of about
20mm; however, dimensions of the partially folded segment 152 are anticipated to vary
depending upon a number of factors, including the amount of desired movement, the
size of the patient that is the recipient of the implant, and the dimensions and material
types used to the construct the device. The dynamic fixation device 150 provides on
the order of approximately ten degrees of rotation in flexion and on the order of
approximately negative two degrees of rotation in the extension.
[0093] Referring now to Fig. 14a, a dynamic fixation device 150 featuring a partially folded
segment 152 is generally shown. The partially folded segment 152 allows dynamic fixation
device 150 to rotate around the effective pivot point 32 when the device 150 is elongated
in flexion. The partially folded segment 152 is attached to a first rod end 14 and
a second rod end 16. The first and second rod ends 14 and 16 are, in turn, connected
to pedicle screws 20 by means of connecters 18a and 18b, respectively.
[0094] At least portions of the dynamic fixation device 150 may be made from one or more
materials that possesses the appropriate strength characteristics necessary to withstand
loading from the human body when used in medical applications. In addition, the materials
may be chosen to provide desired flexibility characteristics. Examples of materials
that may be used to make at least portions of the dynamic fixation device 150 include,
but are not necessarily limited to, polyether ether plastics, such as ketone (PEEK),
polyether ketone ketone (PEKK), ultra high molecular weight polyethylene (UHMWPE),
and polymethylmethacrylate (PMMA); metals, such as titanium and stainless steel; composites;
as well as other tissue compatible materials.
[0095] The partially folded segment 152 comprises a series of planar segments 154. Flexible
joints, such as living hinges 156, connect adjacent planar segments 154. The partially
folded segment 152 may be made of interconnected elements or, alternatively, machined
out of a single piece of material. The planar segments 154 have a rectangular shape.
Each planar segment 154 has two sides 156a and 156b oriented substantially in an anterior-posterior
direction and two sides 158a and 158b oriented substantially in a superior-inferior
direction. As shown in Fig.14a, the dynamic fixation device 150 also has a longitudinal
axis L-L that is defined by the center of connectors 18a and 18b. The length of side
158a, located posterior of longitudinal axis L- L, is same as the length of side 158b,
located anterior of longitudinal axis L- L. Although the sides of the planar segments
154 are of similar length, if the partially folded segment 154 is made of a sufficiently
elastic material, it will accommodate rotation of the dynamic fixation device 150.
Fig. 14b shows a close-up view of the folded segment 152 viewed from the posterior
to anterior direction.
[0096] As shown in the example illustrated in Figs.14c and 14d, first rod end 14 is shown
to remain essentially immobile. Second rod end 16 moves between a neutral or first
position 160, as shown in Fig. 14c, and a flexed or second position 162, as shown
in Fig. 14d. In moving between first position 160 and second position 162, dynamic
fixation device 150 elongates or accommodates elongation, and it also rotates about
a physiologic zone of rotation or an effective pivot point 32. The partially folded
segment 138 provides an effective pivot point 32 that is forward or anterior of the
longitudinal axis L-L. During movement between first position 160 and second position
162, dynamic fixation device 160 experiences deformation, whereby it bends and it
elongates to accommodate at least some motion in flexion of the vertebrae to which
it is attached.
[0097] The folded segment 152 allows the dynamic fixation device 150 to elongate and rotate
about an effective pivot point 32. As the spine moves from the neutral position illustrated
in Fig. 14c to the flexed position depicted in Fig. 14d, the dynamic fixation device
150 undergoes an elongation. This elongation causes the folded segment 150 to unfold.
This allow the device to bend as shown in Fig. 14d. The rotation about the effective
pivot point 32 is due to the planar segments and the flexible joint of the partially
folded segment being made from a material of sufficient strength and flexibility to
allow for the described movement. Such materials may include, but are not limited
to PEEK and PEKK. This motion allows the dynamic fixation device 150 to move in way
that closely approximates the normal motion of the human vertebrae.
[0098] Referring now to Figs. 15a-15c, a dynamic fixation device 170 is shown. The device
includes a plurality of segments 172 connected by hinges 174. The plurality of hinged
segments 172 can bend relatively easier in one direction (flexion) than the other
(extension). Additionally, the plurality of hinged segments 172 resists motion in
the plane of the segment, which corresponds to resisting translational movement. Thus
the dynamic fixation device 170 accommodates at least some rotation at the vertebrae
in flexion, while also resisting translation of the vertebrae.
[0099] Referring now to Figs. 15a, a dynamic fixation device 170 featuring a plurality of
hinged segments 172 is shown. The hinges 174 contain pins 176 that are directed forwardly
or anteriorly of the dynamic fixation device 170. This orientation of the pins 176
of the hinges 174 provides a forwardly or anteriorly projected pivot point 32 that
is similar to the natural pivot point of a first vertebra relative to the second vertebra
when the spine undergoes flexion. The dynamic fixation device 170 features an inferior
hinged segment 172a, a superior hinged segment 172b, and a interior hinged segment
172c. The inferior and superior hinged segments 172a and 172b each have a hinged connection
to connectors 18a and 18b, respectively. The interior hinged segment 172c is disposed
between and has a hinged connection to the inferior and superior hinged segments 172a
and 172b. Connectors 18a and 18b each attach to a pedicle screw 20. The hinges 174
that connect both ends of the superior hinged segment 172b are shown separated in
Fig. 15a in order to illustrate their structure.
[0100] The dynamic fixation device 170 may be made from one or more materials that possess
the appropriate strength characteristics necessary to withstand loading from the human
body when used in medical applications. In addition, the materials may be chosen to
provide desired flexibility characteristics. Examples of materials that may be used
to make at least a portion of the dynamic fixation device 170 include, but are not
limited to: plastics, such as polyether ether ketone (PEEK), polyether ketone ketone
(PEKK), ultra high molecular weight polyethylene (UHMWPE), polymethylmethacrylate
(PMMA); and more preferably, metals, such as titanium and stainless steel. In addition,
the device 170 may be made of a combination of materials, of composites, as well as
other tissue compatible materials.
[0101] Still referring to the example of Fig. 15a, dynamic fixation device 170 also has
a longitudinal axis L-L that is defined by the center of connectors 18a and 18b. Inferior
hinged segment 172a, superior hinged segment 172b, and interior hinged segment 172c
generally lie in a plane perpendicular to the pedicle screws 20 and at an acute angle
with respect to the longitudinal axis L-L.
[0102] The functionality of the dynamic fixation device 170 is illustrated in Figs. 15b
and 15c. Fig. 15b illustrates the dynamic fixation device 170 in neutral position
182, wherein the spine is neither flexed nor extended. The pedicle screw 20 connected
to connecter 18a is attached to a lower vertebra. The pedicle screw 20 connected to
connector 18b is attached to an upper vertebra. Fig. 15c illustrates the dynamic fixation
device 170 in a flexed position 184. In moving between first position 182 and second
position 184, dynamic fixation device 170 elongates and it also rotates about an effective
pivot point 32. During this flexion movement, the plurality of hinged segments 172
rotate in a more superior-inferior alignment, such that at least the segments 172
and 172b become increasingly aligned parallel with respect to longitudinal axis L-L,
thereby providing lengthening to the dynamic fixation device 170 and allowing the
upper vertebra to rotate forward relative to the lower vertebra. In addition, the
relatively rigid materials used to form the construct resist movement in the anterior-posterior
direction, thereby resisting translational motion of the two interconnected vertebrae.
This motion of the hinged segments 172 allows the dynamic fixation device 170 to move
in a way that closely approximates the normal physiological motion of the-human vertebrae.
The dynamic fixation device 170 provides on the order of approximately ten degrees
of rotation in flexion and on the order of approximately negative two degrees of rotation
in the extension.
[0103] For a dynamic fixation device 170 spanning one joint, it will expand up to approximately
5 to 10mm in length, and will rotate forward up to between 5 to 10 degrees to accommodate
flexion of the spine. Obviously, different size dynamic fixation devices 170 may be
used to accommodate the specific needs of each individual patient. More particularly,
a relatively large dynamic fixation device may be needed for a large man, while a
relatively small dynamic fixation device may be needed for a smaller patient, such
as child or a petite woman. However, a limited number of sizes may provide adequate
coverage for the majority of the patient population. For any given device, a potential
elongation of the dynamic fixation device consistent with the desired flexion of the
vetebral motion segment and associated distraction of the plane of the fixation device
is anticipated.
[0104] The hinges as described herein may not comprise a pin. In particular, the devices
illustrated in Fig. 3a, 4a, 5a, 6a, 7a, 8a, 9a, 11a, 12a, 13a, and 14a may contain
flexible elements such as a living hinge.
[0105] The dynamic fixation devices can be used to flexibly secure a plurality of vertebra.
Alternatively, the dynamic fixation devices can be located at specific points where
bending of the spine is desired, while a rigid rod may be used at other locations
desired by the physician. Where used, rigid rod portions may be curved, thereby influencing
the implanted location of the geometric shape hinged structures, and thus the effective
pivot point.
[0106] The structures are made from one or more materials that possesses the appropriate
strength characteristics necessary to withstand loading from the human body when used
in medical applications. In addition, the materials are compatible with the human
body. Preferably, materials include ceramics, plastics, metals, or carbon fiber composites.
More preferably, the materials are made from titanium, a titanium alloy, or stainless
steel.
[0107] The structures are made from one or more materials that possesses the appropriate
strength characteristics necessary to withstand loading from the human body when used
in medical applications. In addition, the materials are compatible with the human
body. Preferably, materials include ceramics, plastics, metals, or carbon fiber composites.
More preferably, the materials are made from titanium, a titanium alloy, or stainless
steel.
[0108] Examples of plastic materials include polyether ether ketone (PEEK), polyether ketone
ketone (PEKK), any material chosen from the polyaryl ether ketone (PAEK) family, ultra
high molecular weight polyethylene (UHMWPE), polymethylmethacrylate (PMMA), polyethlene
terephthalate (PET), fluorinated ethylene propylene (FEP), polyuretheance (PU), polyimide
(PI), polybutylene terephthalate (PBT) polyurethane rubber (PUR). Additionaly, silicon
and silicon rubber are useable, as well as polysulfone, polyimide , epoxy, and polycyanate.
[0109] Elements of the fixation device may be made from a radiolucent polymer, allowing
the device, once implanted in a patient, to be seen by radiographic methods. Examples
of such radiolucent materials include polyether ether ketone and polyether ketone
ketone.
[0110] Materials chosen for compatibility with the human body should be resistant to organic
and inorganic chemicals, have desirable strength and rigidity properties, be resistance
to impact over a wide range of temperatures and be resistant to hydrolysis and corrosion.
[0111] Elements of the dynamic fixation device that are implanted into bone can be made
from bone graft material. Such material can be allographic meaning grown from an organism
of the same species, or xenographic, meaning grown from an organism of a different
species.
[0112] The above described alternative configurations offer different bending characteristics.
The dimensions will vary depending upon the specific design necessary for a specific
patient. More particularly, the dimensions of geometric shapes and hinged devices
will likely be bigger for a large heavy man, as opposed to that needed for a small
petite woman. Furthermore, the type of material used to construct the dynamic fixation
devices described herein will also impact the required dimensions of the devices.
Dynamic fixation devices described herein may be made of a variety of materials, preferably
metals or materials demonstrating resilient characteristics, and more preferably,
a titanium alloy or surgical stainless steel. Since different materials have different
strength and resilient properties, the type of material used will, in part, dictate
the dimensions of the rod portion required to achieve a certain function in a specific
patient.
[0113] Devices disclosed herein can also be made of thermal memory materials or materials
that possess different elastic properties at varying temperatures. The subject component(s)
may be heated or cooled to a desired temperature, implanted, then subsequently allowed
to cool or warm to the temperature of the ambient conditions that will exist during
the usage period for the subject device, namely, normal body temperature.
[0114] The foregoing discussion of the invention has been presented for purposes of illustration
and description. The foregoing is not intended to limit the invention to the form
or forms disclosed herein. In the foregoing Detailed Description Of The Invention
for example, various features of the invention are grouped together in one or more
embodiments for the purpose of streamlining the disclosure. This method of disclosure
is not to be interpreted as reflecting an intention that the claimed invention requires
more features than are expressly recited in each claim. Rather, as the following claims
reflect, inventive aspects lie in less than all features of a single foregoing disclosed
embodiment. Thus, the following claims are hereby incorporated into this Detailed
Description Of The Invention, with each claim standing on its own as a separate preferred
embodiment of the invention.
[0115] While various embodiments of the present invention have been described in detail,
it is apparent that modifications and adaptations of those embodiments will occur
to those skilled in the art.