U.S. patent application number 14/873514 was filed with the patent office on 2016-01-28 for spinal rod system and method.
The applicant listed for this patent is Warsaw Orthopedic, Inc.. Invention is credited to Jason May, William Alan Rezach.
Application Number | 20160022328 14/873514 |
Document ID | / |
Family ID | 47506796 |
Filed Date | 2016-01-28 |
United States Patent
Application |
20160022328 |
Kind Code |
A1 |
Rezach; William Alan ; et
al. |
January 28, 2016 |
SPINAL ROD SYSTEM AND METHOD
Abstract
A spinal rod system includes a first instrument extending
between a proximal portion and a distal portion along a
longitudinal axis thereof. The proximal portion defines an inner
cavity extending along the longitudinal axis. The first instrument
includes a first arm extending along the longitudinal axis. The
first arm defines a portion of a vertebral construct cavity
disposed in communication with the inner cavity and includes a
distal end being configured to engage a bone fastener. Methods of
use are disclosed.
Inventors: |
Rezach; William Alan;
(Atoka, TN) ; May; Jason; (Cordova, TN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Warsaw Orthopedic, Inc. |
Warsaw |
IN |
US |
|
|
Family ID: |
47506796 |
Appl. No.: |
14/873514 |
Filed: |
October 2, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13182149 |
Jul 13, 2011 |
9204909 |
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14873514 |
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Current U.S.
Class: |
606/265 ;
606/86A |
Current CPC
Class: |
A61B 17/7032 20130101;
A61B 17/7085 20130101; A61B 17/7076 20130101; A61B 17/7086
20130101 |
International
Class: |
A61B 17/70 20060101
A61B017/70 |
Claims
1-17. (canceled)
18. A spinal rod system comprising: at least one first instrument
extending along a longitudinal axis thereof and including a tubular
proximal portion that defines an inner cavity and a distal portion
that includes a first arm extending along the longitudinal axis and
defining at least a portion of a vertebral construct cavity
disposed in communication with the inner cavity, the first arm
extending distally from the proximal portion and including a first
movable leg extension defining a distal engagement part and a
second movable leg extension defining a distal engagement part, the
leg extensions defining an axial arm cavity, the at least one first
instrument further including a first actuator arm movable within
the axial arm cavity along the longitudinal axis, the actuator arm
being engageable with the leg extensions to cause the distal
engagement parts to move in a direction transverse to the
longitudinal axis between an open position and a closed position
such that the distal engagement parts releasably capture a bone
fastener, at least one second instrument extending between a
proximal end and a distal end thereof, the at least one second
instrument being disposable in the inner cavity such that the
distal end of the at least one second instrument engages a bone
fastener in a configuration to support the bone fastener with the
distal engagement parts; and at least one third instrument
extending between a proximal end and a distal end thereof, the at
least one third instrument being disposable in the inner cavity
such that the distal end of the at least one third instrument is
engageable with a vertebral construct disposed in the vertebral
construct cavity in a configuration to move the vertebral construct
into engagement with a bone fastener.
19. (canceled)
20. A spinal rod system comprising: at least one bone fastener; an
extender disposed along a longitudinal axis thereof and including a
cylindrical proximal portion that defines an inner cavity having an
inner surface and a distal portion that includes an arm extending
along the longitudinal axis and defining at least a portion of a
vertebral construct cavity disposed in communication with the inner
cavity, the arm extending distally from the proximal portion and
including a first movable leg extension defining a distal
engagement part and a second movable leg extension defining a
distal engagement part, the leg extensions extending in a
cantilevered configuration from the proximal portion and being
oriented to define an axial arm cavity therebetween, the extender
further including an actuator arm axially movable within the axial
arm cavity and a handle, connected with the actuator arm, which
includes a grip surface configured to facilitate axial movement of
the actuator arm, the actuator arm being engageable with the leg
extensions to cause the distal engagement parts to move in a
direction transverse to the longitudinal axis between an open
position and a closed position such that the distal engagement
parts releasably capture a bone fastener, an inserter extending
between a proximal end and a distal end thereof, the inserter being
slidably disposable in the inner cavity and along the inner surface
such that the distal end of the inserter engages the at least one
bone fastener in a configuration to support the at least one bone
fastener with the distal engagement parts; and a reducer extending
between a proximal end and a distal end thereof, the reducer being
disposable in the inner cavity and defining an outer threaded
surface, the outer threaded surface engaging the inner surface of
the proximal portion of the extender to facilitate axial movement
of the reducer relative to the extender such that the distal end of
the reducer includes a pusher that is engageable with a vertebral
construct disposed in the vertebral construct cavity in a
configuration to move the vertebral construct into engagement with
a bone fastener, wherein the pusher is rotatable relative to the
reducer and configured to engage the first arm to prevent rotation
of the pusher relative to the at least one first arm.
21. A spinal rod system as recited in claim 18, wherein the
actuator arm comprises a distal head that tapers distally to an
increased width such that moving the actuator arm proximally along
the longitudinal axis causes the distal engagement parts to move
from the closed position to the open position.
22. A spinal rod system as recited in claim 18, wherein the
actuator arm is coupled to a handle, the handle being configured to
move proximally along the longitudinal axis to cause the distal
engagement parts to move from the closed position to the open
position.
23. A spinal rod system as recited in claim 22, wherein the distal
engagement parts are biased to the closed position such that moving
the handle distally along the longitudinal axis causes the distal
engagement parts to move from the open position to the closed
position.
24. A spinal rod system as recited in claim 22, wherein the handle
comprises an aperture, the tubular proximal portion extending
through the aperture such that the handle is able to translate in
opposite directions along the longitudinal axis.
25. A spinal rod system as recited in claim 18, further comprising
the bone fastener, the bone fastener comprising a first extension
and a second extension that is spaced apart from the first
extension, the extensions defining a U-shaped cavity therebetween,
the distal engagement parts being configured to engage the first
extension such that the at least one first instrument being spaced
apart from the second extension when the distal engagement parts
engage the first extension.
26. A spinal rod system as recited in claim 18, wherein the first
actuator arm comprises a slot that extends transverse to the
longitudinal axis, the slot comprising a slide disposed therein,
the slide having a first end disposed in a tapered slot of the
first movable leg extension and a second end disposed in a tapered
slot of the second movable leg extension such that translation of
the slide along the longitudinal axis in opposite directions moves
the distal engagement parts between the open and closed
positions.
27. A spinal rod system as recited in claim 26, wherein the tapered
slots are configured to allow and limit movement of the first
actuator arm and facilitate retention of the distal engagement
parts in the open and closed positions.
28. A spinal rod system as recited in claim 18, wherein the inner
cavity is coaxial with the longitudinal axis and the first arm is
offset from the longitudinal axis.
29. A spinal rod system as recited in claim 18, wherein the at
least one second instrument defines an outer surface having an
enlarged portion configured to friction fit with an inner surface
of the proximal portion of the at least one first instrument.
30. A spinal rod system as recited in claim 29, wherein the inner
surface of the proximal portion of the at least one first
instrument is a non-threaded portion of the inner surface of the
proximal portion.
31. A spinal rod system as recited in claim 30, wherein the
non-threaded portion is positioned between threaded portions of the
inner surface of the proximal portion.
32. A spinal rod system as recited in claim 18, wherein the at
least one second instrument comprises an elongated body that is
defined by side walls and end walls, the side walls having a
greater dimension than the end walls such that the elongated body
has a flattened bar configuration.
33. A spinal rod system as recited in claim 32, further comprising
the bone fastener, the bone fastener comprising a first extension
and a second extension that is spaced apart from the first
extension, the extensions defining a U-shaped cavity therebetween,
wherein the end walls are positioned within the U-shaped cavity
when the at least one second instrument is disposed in the inner
cavity.
34. A spinal rod system as recited in claim 32, wherein the side
walls defining an axial slot such that the elongated body includes
a second arm and a third arm, wherein the axial slot provides the
second and third arms with a spring force and flexibility to
facilitate to releasable engagement with a non-threaded portion of
the inner cavity, the end walls including a bulge, wherein upon
disposal of the at least one second instrument within the inner
cavity, the bulges are releasably engaged with the non-threaded
portion the bulge, under an outward bias provided by the second and
third arms is configured to interfere with the non-threaded portion
to create a friction fit between the at least one first instrument
and the at least one second instrument.
35. A spinal rod system as recited in claim 18, wherein the at
least one third instrument defines a threaded outer surface
engageable with an inner surface of the proximal portion of the at
least one first instrument in a configuration to facilitate axial
movement of the at least one third instrument relative to the at
least one first instrument.
36. A spinal rod system as recited in claim 18, further comprising
the vertebral construct, wherein the vertebral construct is a
spinal rod and the distal end of the at least one third instrument
includes a pusher configured to engage the spinal rod, the pusher
being engageable with the first arm to prevent rotation of the
pusher relative to the first arm.
37. A spinal rod system as recited in claim 18, wherein the pusher
comprises a flange and spaced apart legs that extend from the
flange, the legs each comprising arcuate end surfaces that define a
channel configured for disposal of the spinal rod.
38. A spinal rod system as recited in claim 18, wherein the at
least one third instrument comprises a shaft having a threaded
proximal end and a non-threaded distal end, the at least one third
instrument comprising a pusher coupled to the distal end of the
shaft such that the pusher is rotatable relative to the shaft.
Description
TECHNICAL FIELD
[0001] The present disclosure generally relates to medical devices
for the treatment of musculoskeletal disorders, and more
particularly to a surgical system for implant delivery to a
surgical site and a method for treating a spine.
BACKGROUND
[0002] Spinal pathologies and disorders such as scoliosis and other
curvature abnormalities, kyphosis, degenerative disc disease, disc
herniation, osteoporosis, spondylolisthesis, stenosis, tumor, and
fracture may result from factors including trauma, disease and
degenerative conditions caused by injury and aging. Spinal
disorders typically result in symptoms including deformity, pain,
nerve damage, and partial or complete loss of mobility.
[0003] Non-surgical treatments, such as medication, rehabilitation
and exercise can be effective, however, may fail to relieve the
symptoms associated with these disorders. Surgical treatment of
these spinal disorders includes correction, fusion, fixation,
discectomy, laminectomy and implantable prosthetics. Correction
treatments used for positioning and alignment may employ rods and
fasteners that are manipulated for engagement. This disclosure
describes an improvement over these prior art technologies.
SUMMARY OF THE INVENTION
[0004] Accordingly, a surgical system is provided for implant
delivery to a surgical site and a method for treating a spine. It
is contemplated, for example, such delivery can include attachment
of a vertebral rod to a bone anchor and reduction of the rod. It is
further contemplated that the surgical system and method may be
employed for scoliosis and kyphosis treatment.
[0005] In one particular embodiment, in accordance with the
principles of the present disclosure, a spinal rod system is
provided. The spinal rod system includes at least one first
instrument extending between a proximal portion and a distal
portion along a longitudinal axis thereof. The proximal portion
defines an inner cavity extending along the longitudinal axis. The
at least one first instrument includes at least one first arm
extending along the longitudinal axis. The at least one first arm
defines at least a portion of a vertebral construct cavity disposed
in communication with the inner cavity and includes a distal end
being configured to engage a bone fastener.
[0006] In one embodiment, the spinal rod system includes at least
one first instrument extending along a longitudinal axis thereof
and including a tubular proximal portion that defines an inner
cavity and a distal portion that includes a first arm extending
along the longitudinal axis and defining at least a portion of a
vertebral construct cavity disposed in communication with the inner
cavity. The first arm extends distally from the proximal portion
and includes a first movable leg extension defining a distal
engagement part and a second movable leg extension defining a
distal engagement part. The leg extensions define an axial arm
cavity. The at least one first instrument further includes a first
actuator arm movable within the axial arm cavity along the
longitudinal axis. The actuator arm is engageable with the leg
extensions to cause the distal engagement parts to move in a
direction transverse to the longitudinal axis between an open
position and a closed position such that the distal engagement
parts releasably capture a bone fastener. At least one second
instrument extends between a proximal end and a distal end thereof.
The at least one second instrument is disposable in the inner
cavity such that the distal end of the at least one second
instrument engages a bone fastener in a configuration to support
the bone fastener with the distal engagement parts. At least one
third instrument extends between a proximal end and a distal end
thereof. The at least one third instrument is disposable in the
inner cavity such that the distal end of the at least one third
instrument is engageable with a vertebral construct disposed in the
vertebral construct cavity in a configuration to move the vertebral
construct into engagement with a bone fastener.
[0007] In one embodiment, the spinal rod system includes at least
one bone fastener. An extender is disposed along a longitudinal
axis thereof and includes a cylindrical proximal portion that
defines an inner cavity having an inner surface and a distal
portion that includes an arm extending along the longitudinal axis
and defining at least a portion of a vertebral construct cavity
disposed in communication with the inner cavity. The arm extends
distally from the proximal portion and includes a first movable leg
extension defining a distal engagement part and a second movable
leg extension defining a distal engagement part. The leg extensions
extend in a cantilevered configuration from the proximal portion
and are oriented to define an axial arm cavity therebetween. The
extender further includes an actuator arm axially movable within
the axial arm cavity and a handle, connected with the actuator arm,
which includes a grip surface configured to facilitate axial
movement of the actuator arm. The actuator arm is engageable with
the leg extensions to cause the distal engagement parts to move in
a direction transverse to the longitudinal axis between an open
position and a closed position such that the distal engagement
parts releasably capture a bone fastener. An inserter extends
between a proximal end and a distal end thereof. The inserter is
slidably disposable in the inner cavity and along the inner surface
such that the distal end of the inserter engages the at least one
bone fastener in a configuration to support the at least one bone
fastener with the distal engagement parts. A reducer extends
between a proximal end and a distal end thereof. The reducer is
disposable in the inner cavity and defines an outer threaded
surface. The outer threaded surface engages the inner surface of
the proximal portion of the extender to facilitate axial movement
of the reducer relative to the extender such that the distal end of
the reducer includes a pusher that is engageable with a vertebral
construct disposed in the vertebral construct cavity in a
configuration to move the vertebral construct into engagement with
a bone fastener. The pusher is rotatable relative to the reducer
and configured to engage the first arm to prevent rotation of the
pusher relative to the at least one first arm.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] The present disclosure will become more readily apparent
from the specific description accompanied by the following
drawings, in which:
[0009] FIG. 1 is a perspective view of one particular embodiment of
a first instrument of a system in accordance with the principles of
the present disclosure;
[0010] FIG. 2 is a perspective view of the first instrument shown
in FIG. 1 with parts separated;
[0011] FIG. 3 is a side view of the first instrument shown in FIG.
1;
[0012] FIG. 4 is a front view of the first instrument shown in FIG.
1;
[0013] FIG. 5 is a side view of the first instrument shown in FIG.
1;
[0014] FIG. 6 is a side view of the first instrument shown in FIG.
1;
[0015] FIG. 7 is a front view of the first instrument shown in FIG.
1;
[0016] FIG. 8 is a section view of the first instrument shown along
lines XIII-XIII of FIG. 7;
[0017] FIG. 9 is a perspective view of the first instrument shown
in FIG. 1 engaged with a fastener;
[0018] FIG. 10 is a side view of one embodiment of a second
instrument of a system in accordance with the principles of the
present disclosure;
[0019] FIG. 11 is a front view of the second instrument shown in
FIG. 10;
[0020] FIG. 12 is an end view of the second instrument shown in
FIG. 10;
[0021] FIG. 13 is a perspective view of the first instrument shown
in FIG. 1 engaged with the second instrument shown in FIG. 10 and a
fastener;
[0022] FIG. 14 is a perspective view of one embodiment of a third
instrument of a system in accordance with the principles of the
present disclosure;
[0023] FIG. 15 is a perspective view of the third instrument shown
in FIG. 14 with parts separated;
[0024] FIG. 16 is an axial view of a spine and a side view of a
plurality of the first instrument shown in FIG. 1 and fasteners,
and a plurality of the second instrument shown in FIG. 10;
[0025] FIG. 17 is an oblique view of a section of the spine shown
in FIG. 16 and a side view of a plurality of the first instrument
shown in FIG. 1 and fasteners, and a plurality of the third
instrument shown in FIG. 14 engaging a rod in phantom;
[0026] FIG. 18 is a perspective view of one embodiment of the first
instrument shown in FIG. 1;
[0027] FIG. 19 is a perspective view of the first instrument shown
in FIG. 18 with parts separated;
[0028] FIG. 20 is a perspective view of one embodiment of the first
instrument shown in FIG. 1;
[0029] FIG. 21 is a perspective view of the first instrument shown
in FIG. 20 engaged with a fastener;
[0030] FIG. 22 is a perspective view of a first arm of the first
instrument shown in FIG. 20;
[0031] FIG. 23 is a front view of the first arm shown in FIG.
22;
[0032] FIG. 24 is an end view of the first arm shown in FIG.
22;
[0033] FIG. 25 is a side view of the first arm taken along lines
XXV-XXV shown in FIG. 23;
[0034] FIG. 26 is a back view of a second arm of the first
instrument shown in FIG. 20;
[0035] FIG. 27 is an end view of the second arm shown in FIG.
26;
[0036] FIG. 28 is a front view of the second arm shown in FIG.
26;
[0037] FIG. 29 is a side view of the second arm shown in FIG.
26;
[0038] FIG. 30 is a perspective view of the second arm shown in
FIG. 26;
[0039] FIG. 31 is an enlarged detail view of the detail of the
second arm shown in FIG. 30;
[0040] FIG. 32 is a perspective view of one embodiment of the third
instrument shown in FIG. 14;
[0041] FIG. 33 is a perspective view of the third instrument shown
in FIG. 32 with parts separated;
[0042] FIG. 34 is a side view of the third instrument shown in FIG.
32;
[0043] FIG. 35 is an end view of the third instrument shown in FIG.
32;
[0044] FIG. 36 is a section view of the third instrument shown
along lines XXXVI-XXXVI of FIG. 34;
[0045] FIG. 37 is an enlarged detail view of the detail of the
third instrument shown in FIG. 36;
[0046] FIG. 38 is a perspective view of the first instrument shown
in FIG. 21 and the third instrument shown in FIG. 32 engaging a
vertebral construct;
[0047] FIG. 39 is a perspective view of one embodiment of the first
instrument shown in FIG. 20;
[0048] FIG. 40 is a perspective view of the first instrument shown
in FIG. 39 engaging a fastener;
[0049] FIG. 41 is a perspective view of the first instrument shown
in FIG. 39 engaging a fastener and the third instrument shown in
FIG. 32 engaging a vertebral construct;
[0050] FIG. 42 is a perspective view of the first instrument shown
in FIG. 39 engaging a fastener and one embodiment of a handle;
[0051] FIG. 43 is a front view of the system shown in FIG. 38
including one embodiment of a quick release locking system engaging
a fastener and a vertebral construct;
[0052] FIG. 44 is an end section view of the system shown along
lines XLIV-XLIV of FIG. 43;
[0053] FIG. 45 is a perspective view of a locking element shown in
FIG. 43;
[0054] FIG. 46 is a front view of the system shown in FIG. 43;
and
[0055] FIG. 47 is an end section view of the system shown along
lines XLVII-XLVII of FIG. 46.
[0056] Like reference numerals indicate similar parts throughout
the figures.
DETAILED DESCRIPTION OF THE INVENTION
[0057] The exemplary embodiments of the surgical system and related
methods of use disclosed are discussed in terms of medical devices
for the treatment of musculoskeletal disorders and more
particularly, in terms of a surgical system for implant delivery to
a surgical site and a method for treating a spine. It is envisioned
that the surgical system can include an instrument system having
extenders, reducers and translators, which can be used to introduce
a vertebral construct such as a rod to a bone fastener such as a
bone anchor or bone screw. For example, an extender can include
bone anchor attachment features on one or both sides of the
instrument. It is contemplated that the system may be used with a
reducer assembly to introduce a rod into a bone fastener.
[0058] It is envisioned that the system may include instruments
that are connected or attach to an extender(s) such as, for
example, a lateral translation handle or derotaton instruments. It
is further envisioned that the system may have an extender with a
quick release mechanism to allow a reducer to slide into engagement
with a rod. It is contemplated that the system can include an
extender having features that prevent a rod and/or reducer assembly
from rotating. In one embodiment, one or all of the components of
the surgical system are disposable, peel-pack, pre-packed sterile
devices used with an implant. One or all of the components of the
surgical system may be reusable. The surgical system may be
configured as a kit with multiple sized and configured
components.
[0059] It is envisioned that the present disclosure may be employed
to treat spinal disorders such as, for example, degenerative disc
disease, disc herniation, osteoporosis, spondylolisthesis,
stenosis, scoliosis and other curvature abnormalities, kyphosis,
tumor and fractures. It is contemplated that the present disclosure
may be employed with other osteal and bone related applications,
including those associated with diagnostics and therapeutics. It is
further contemplated that the disclosed surgical system and methods
may be alternatively employed in a surgical treatment with a
patient in a prone or supine position, and/or employ various
surgical approaches to the spine, including anterior, posterior,
posterior mid-line, postero-lateral, and/or antero-lateral
approaches, and in other body regions. The present disclosure may
also be alternatively employed with procedures for treating the
lumbar, cervical, thoracic and pelvic regions of a spinal column.
The system and methods of the present disclosure may also be used
on animals, bone models and other non-living substrates, such as,
for example, in training, testing and demonstration.
[0060] The present invention may be understood more readily by
reference to the following detailed description of the invention
taken in connection with the accompanying drawing figures, which
form a part of this disclosure. It is to be understood that this
invention is not limited to the specific devices, methods,
conditions or parameters described and/or shown herein, and that
the terminology used herein is for the purpose of describing
particular embodiments by way of example only and is not intended
to be limiting of the claimed invention. Also, as used in the
specification and including the appended claims, the singular forms
"a," "an," and "the" include the plural, and reference to a
particular numerical value includes at least that particular value,
unless the context clearly dictates otherwise. Ranges may be
expressed herein as from "about" or "approximately" one particular
value and/or to "about" or "approximately" another particular
value. When such a range is expressed, another embodiment includes
from the one particular value and/or to the other particular value.
Similarly, when values are expressed as approximations, by use of
the antecedent "about," it will be understood that the particular
value forms another embodiment. It is also understood that all
spatial references, such as, for example, horizontal, vertical,
top, upper, lower, bottom, left and right, are for illustrative
purposes only and can be varied within the scope of the disclosure.
For example, the references "upper" and "lower" are relative and
used only in the context to the other, and are not necessarily
"superior" and "inferior".
[0061] Further, as used in the specification and including the
appended claims, "treating" or "treatment" of a disease or
condition refers to performing a procedure that may include
administering one or more drugs to a patient (human, normal or
otherwise or other mammal), in an effort to alleviate signs or
symptoms of the disease or condition. Alleviation can occur prior
to signs or symptoms of the disease or condition appearing, as well
as after their appearance. Thus, treating or treatment includes
preventing or prevention of disease or undesirable condition (e.g.,
preventing the disease from occurring in a patient, who may be
predisposed to the disease but has not yet been diagnosed as having
it). In addition, treating or treatment does not require complete
alleviation of signs or symptoms, does not require a cure, and
specifically includes procedures that have only a marginal effect
on the patient. Treatment can include inhibiting the disease, e.g.,
arresting its development, or relieving the disease, e.g., causing
regression of the disease. For example, treatment can include
reducing acute or chronic inflammation; alleviating pain and
mitigating and inducing re-growth of new ligament, bone and other
tissues; as an adjunct in surgery; and/or any repair procedure.
Also, as used in the specification and including the appended
claims, the term "tissue" includes soft tissue, ligaments, tendons,
cartilage and/or bone unless specifically referred to
otherwise.
[0062] The following discussion includes a description of a
surgical system and related methods of employing the surgical
system in accordance with the principles of the present disclosure.
Alternate embodiments are also disclosed. Reference will now be
made in detail to the exemplary embodiments of the present
disclosure, which are illustrated in the accompanying figures.
Turning now to FIGS. 1-8, there is illustrated components of a
surgical system, such as, for example, a spinal rod system in
accordance with the principles of the present disclosure.
[0063] The components of the spinal rod system can be fabricated
from biologically acceptable materials suitable for medical
applications, including metals, synthetic polymers, ceramics and
bone material and/or their composites, depending on the particular
application and/or preference of a medical practitioner. For
example, the components of the spinal rod system, individually or
collectively, can be fabricated from materials such as stainless
steel alloys, commercially pure titanium, titanium alloys, Grade 5
titanium, super-elastic titanium alloys, cobalt-chrome alloys,
stainless steel alloys, superelastic metallic alloys (e.g.,
Nitinol, super elasto-plastic metals, such as GUM METAL.RTM.
manufactured by Toyota Material Incorporated of Japan), ceramics
and composites thereof such as calcium phosphate (e.g., SKELITE.TM.
manufactured by Biologix Inc.), thermoplastics such as
polyaryletherketone (PAEK) including polyetheretherketone (PEEK),
polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK
composites, PEEK-BaSO.sub.4 polymeric rubbers, polyethylene
terephthalate (PET), fabric, silicone, polyurethane,
silicone-polyurethane copolymers, polymeric rubbers, polyolefin
rubbers, hydrogels, semi-rigid and rigid materials, elastomers,
rubbers, thermoplastic elastomers, thermoset elastomers,
elastomeric composites, rigid polymers including polyphenylene,
polyamide, polyimide, polyetherimide, polyethylene, epoxy, bone
material including autograft, allograft, xenograft or transgenic
cortical and/or corticocancellous bone, and tissue growth or
differentiation factors, partially resorbable materials, such as,
for example, composites of metals and calcium-based ceramics,
composites of PEEK and calcium based ceramics, composites of PEEK
with resorbable polymers, totally resorbable materials, such as,
for example, calcium based ceramics such as calcium phosphate,
tri-calcium phosphate (TCP), hydroxyapatite (HA)-TCP, calcium
sulfate, or other resorbable polymers such as polyaetide,
polyglycolide, polytyrosine carbonate, polycaroplaetohe and their
combinations. Various components of the spinal rod system may have
material composites, including the above materials, to achieve
various desired characteristics such as strength, rigidity,
elasticity, compliance, biomechanical performance, durability and
radiolucency or imaging preference. The components of the spinal
rod system, individually or collectively, may also be fabricated
from a heterogeneous material such as a combination of two or more
of the above-described materials. The components of the spinal rod
system may be monolithically formed, integrally connected or
include fastening elements and/or instruments, as described
herein.
[0064] The spinal rod system is employed, for example, with an open
or mini-open surgical technique to deliver and introduce an
implant, such as, for example, a vertebral construct such as a rod
to an implant, such as, for example, a bone fastener, at a surgical
site within a body of a patient, for example, a section of a spine.
In one embodiment, the components of the spinal rod system are
configured to position the vertebral rod into engagement with the
bone fastener for a correction treatment to treat various spine
pathologies, such as, for example, adolescent idiopathic scoliosis
and Scheuermann's kyphosis.
[0065] The spinal rod system includes a first instrument, such as,
for example, an extender 52 that extends along a longitudinal axis
a between a proximal portion 54 and a distal portion 56. Proximal
portion 54 includes a tubular body 58 having a cylindrical
cross-section configuration and a proximal opening 60. Body 58
extends axially from opening 60. It is contemplated that body 58
may extend from opening 60 in alternate configurations such as, for
example, having a radius of curvature, offset and/or staggered. It
is further contemplated that body 58 may extend at transverse
orientations from opening 60, relative to longitudinal axis a, for
example, perpendicular and/or other angular orientations such as
acute or obtuse, co-axial and/or parallel.
[0066] Tubular body 58 includes an inner surface 62 that defines an
inner cavity, such as, for example, a passageway 64. Inner surface
62 includes a threaded portion 66 and a smooth, non-threaded
portion 68. Portions 66, 68 are each particularly configured for
engagement with a particular instrument, as will be described. Body
58 is configured for disposal of surgical instruments to deliver
one or more implants to a surgical site, as will be described. Body
58 includes an outer surface 70. Body 58 also includes a splined
surface 72 and a retainer 74 that can be utilized for attachment of
other instruments.
[0067] It is contemplated that the thickness defined by surfaces
62, 70 may be uniformly increasing or decreasing, or have alternate
diameter dimensions along longitudinal axis a. It is further
contemplated that all or only a portion of surfaces 62, 70 may have
alternate surface configurations, such as, for example, rough,
threaded for connection with surgical instruments, arcuate,
undulating, porous, semi-porous, dimpled, polished and/or textured
according to the requirements of a particular application. It is
envisioned that body 58 may have alternate cross section
configurations, such as, for example, oval, oblong, triangular,
rectangular, square, polygonal, irregular, uniform, non-uniform,
variable and/or tapered. It is further envisioned that body 58 may
include fastening elements such as anchors, detents and/or openings
for connection to surgical instruments.
[0068] Distal portion 56 includes an arm 76 extending along
longitudinal axis a and defining at least a portion of a vertebral
construct cavity, such as, for example, a rod slot 78 disposed in
communication with passageway 64. Arm 76 extends distally in a
linear orientation from body 58. It is contemplated that arm 76 may
extend from body 58 in alternate configurations such as, for
example, those alternatives described herein. It is further
contemplated that arm 76 may extend at transverse orientations
relative to longitudinal axis a, for example, perpendicular and/or
other angular orientations such as acute or obtuse, co-axial and/or
parallel.
[0069] Arm 76 includes a first movable leg extension 79 that
defines a distal engagement part 80 and a second movable leg
extension 82 that defines a distal engagement part 83. Leg
extensions 79, 82 extend in a cantilevered configuration from body
58 and are flexible to facilitate movement relative to proximal
portion 54 between a first position, such as, for example, an open
position (FIG. 3) and a second position, such as, for example, a
closed position (FIG. 5) such that parts 80, 83 engage a bone
fastener, as will be described. The moving flexibility of leg
extensions 79, 82 provide a resilient configuration such that
extensions 79, 82 are biased to the closed position. It is
contemplated that arm 76 may include one or a plurality of leg
extensions. It is further contemplated that one or both of leg
extensions 79, 82 may extend in alternate configurations and
orientations, such as, for example, those alternatives described
herein. It is envisioned that leg extensions 79, 82 may be
pivotally movable.
[0070] Leg extensions 79, 82 include walls 84, 86, respectively,
that are oriented to define an axial arm cavity 88 therebetween.
Arm cavity 88 includes a proximal section 90 and a distal section
92. Arm cavity 88 is elongated and configured according to the
configuration of walls 84, 86 and orientation of extensions 79, 82,
as will be described.
[0071] Extender 52 includes an actuator arm 94 configured for
slidable disposal within arm cavity 88. Actuator arm 94 is axially
movable within arm cavity 88 to move leg extensions 79, 82 between
the open and the closed positions. Actuator arm 94 has an elongated
portion 96 and a distal head 98. Elongated portion 96 includes
walls 100 that have a generally uniform configuration for slidable
engagement with walls 84, 86. Distal head 98 is enlarged relative
to elongated portion 96 and tapers distally to an increased
width.
[0072] It is contemplated that the thickness of actuator arm 94 may
be uniformly increasing or decreasing, or have alternate diameter
dimensions along longitudinal axis a. It is further contemplated
that all or only a portion of surfaces of actuator arm 94 may have
alternate surface configurations, such as, for example, those
alternatives described herein. It is envisioned that actuator arm
94 may have alternate cross section configurations, such as, for
example, oval, oblong, triangular, rectangular, square, polygonal,
irregular, uniform, non-uniform, variable and/or tapered.
[0073] Elongated portion 96 includes an aperture 102 that receives
a pin 104 for connecting actuator arm 94 with a handle, such as,
for example, an instrument release 106. Instrument release 106 has
a grip surface 108 that is manipulable to facilitate axial movement
of actuator arm 94 and thereby cause leg extensions 79, 82 to move.
It is contemplated that all or only a portion of the surfaces of
instrument release 106 may have alternate surface configurations,
such as, for example, those alternatives described herein.
[0074] Walls 84, 86 define a distal surface 110 having a tapered
configuration for engaging distal head 98, as shown in FIG. 8. As
the tapered configuration of distal head 98 slides along surface
110, engagement of their respective surfaces causes reciprocal and
complimentary motion in leg extensions 79, 82 such that distal
engagement parts 80, 83 move in a direction transverse to
longitudinal axis a between the closed position and the opened
position such that distal engagement parts 80, 83 are in an open
state. In the closed state, the engagement parts 80, 83 releasably
capture a bone fastener (FIG. 9).
[0075] Distal head 98 includes an aperture 112 that receives a pin
114 for connecting actuator arm 94 with leg extensions 79, 82. Pin
114 engages a slide 116, disposed in a slot of distal head 94,
having a dogbone configuration with enlarged end portions 117.
Enlarged end portions 117 are tapered and are configured to
slidably engage tapered slots 118 of leg extensions 79, 82. Tapered
slots 118 each include a tapered track surface 120 configured to
engage enlarged end portions 117. Due to the described connection
of distal head 98 with slide 116, enlarged end portions 117 slide
along tapered track surfaces 120 such that engagement of their
respective surfaces causes reciprocal and complimentary motion in
leg extensions 79, 82 and distal engagement parts 80, 83. As such,
slots 118 are configured to allow and limit movement of arm 94 and
facilitate retention of distal engagement parts 80, 83 in the open
and closed positions.
[0076] Distal engagement part 80 includes an engagement surface 121
for engaging and capturing a bone fastener, as shown in FIG. 6.
Engagement surface 121 includes an arcuate surface 122 configured
to contour and conform to a bone faster to facilitate attachment
thereto. Engagement surface 121 includes a tab 124 that engages and
is received by a complimentary cavity of a bone fastener to
facilitate releasable fixation of extender 52 with a bone
fastener.
[0077] Distal engagement part 83 includes an engagement surface 123
for engaging and capturing a bone fastener. Engagement surface 123
includes an arcuate surface 126 configured to contour and conform
to a bone faster to facilitate attachment thereto. Engagement
surface 123 includes a tab 128 that engages and is received by a
complimentary cavity of a bone fastener to facilitate releasable
fixation of extender 52 with a bone fastener. This configuration of
extender 52 provides a single sided engagement with a bone
fastener, as will be described. It is contemplated that all or only
a portion of the engagement surfaces of distal engagement parts 80,
83 may have alternate surface configurations, such as, for example,
those alternatives described herein. It is contemplated that the
spinal rod system may include an extender that engages a bone
fastener from one or a plurality of sides.
[0078] In operation of the spinal rod system, extender 52 is
oriented for manipulation. Grip surface 108 is engaged and
instrument release 106 is manipulated, in the direction shown by
arrow A in FIG. 4, such that actuator arm 94 is slid proximally
along longitudinal axis a. Distal head 98 slides along surface 110
proximally such that engagement of their respective surfaces causes
reciprocal and complimentary motion in leg extensions 79, 82 in an
outward direction transverse to longitudinal axis a, as shown by
arrows B in FIG. 3, against the inward bias of leg extensions 79,
82.
[0079] Slots 118 guide proximal movement of actuator arm 94 via
engagement with slide 116. A proximal end of each of slots 118
provide a proximal movement limit for arm 94 as slide 116 engages
such proximal end. Slide 116 is releasably fixed at the proximal
movement limit due to the engagement of enlarged ends 117 with the
configuration of track surface 120 adjacent the proximal end of
slot 118. Distal engagement parts 80, 83 move outwardly and are
disposed in the open position, as shown in FIG. 3.
[0080] Extender 52 is manipulated such that distal engagement parts
80, 83 are brought into close proximity with a head 132 of a bone
fastener 130, as shown in FIG. 9. Engagement surfaces 121, 123 are
aligned with a first extension 131 of head 132. Tabs 124, 128 are
aligned with corresponding receiving cavities 134 of first
extension 131 to provide a single sided engagement.
[0081] Grip surface 108 is engaged and instrument release 106 is
manipulated, in the direction shown by arrow C in FIG. 7, such that
actuator arm 94 is slid distally along longitudinal axis a. Distal
head 98 slides along surface 110 distally such that engagement of
their respective surfaces causes reciprocal and complimentary
motion in leg extensions 79, 82 in an inward direction transverse
to longitudinal axis a, as shown by arrows D in FIG. 5, via the
inward bias of leg extensions 79, 82.
[0082] Slots 118 guide distal movement of actuator arm 94 via
engagement with slide 116. Distal engagement parts 80, 83 move
inwardly. A distal end of slots 118 provide a distal movement limit
for actuator arm 94 as slide 116 engages such distal end. Tabs 124,
128 are received by cavities 134 of first extension 131 to capture
bone fastener 130 in releasable fixation. Slide 116 is releasably
fixed at the distal movement limit due to the engagement of
enlarged ends 117 with the configuration of track surface 120
adjacent the distal end of slot 118. Distal engagement parts 80, 83
are disposed in the closed position, as shown in FIG. 5.
[0083] The spinal rod system includes a second instrument, such as,
for example, an inserter 136, as shown in FIGS. 10-13, configured
to align bone fastener 130 with arm 76. Inserter 136 extends
between a proximal end 138 and a distal end 140. Inserter 136 is
disposable in passageway 64 such that distal end 140 engages bone
fastener 130 in a configuration to align bone fastener 130 with
distal engagement parts 80, 83.
[0084] Proximal end 138 includes a handle, such as, for example, a
removal knob 142 having a grip surface 144 configured to facilitate
axial movement of inserter 136 within passageway 64 along
longitudinal axis a. Removal knob 142 is manipulable to dispose
inserter 136 within passageway 64.
[0085] Inserter 136 has an elongated body 146 defined by side walls
148 and end walls 150. Side walls 148 have a greater dimension than
end walls 150 such that body 146 has a flattened bar configuration.
Side walls 148 define an axial slot 152 such that body 146 includes
a first arm 154 and a second arm 156. Slot 152 provides arms 154,
156 with a spring force and flexibility to facilitate to releasable
engagement with non-threaded portion 68 of surface 62. End walls
150 include an enlarged portion, such as, for example, a bulge 158.
Upon disposal of inserter 136 within passageway 64, bulge 158 is
releasably engaged with non-threaded portion 68. Bulge 158, under
the outward bias provided by arms 154, 156, is configured to
interfere with non-threaded portion 68 to create a friction fit
between extender 52 and inserter 136. It is contemplated that all
or only a portion of body 146 may have various geometric
configurations, such as, for example, those described herein.
[0086] Distal end 140 defines a profile configured to mate with a
U-shaped channel 160 (FIG. 9) of bone fastener 130, as shown in
FIG. 12. Upon capture of bone fastener 130 with distal engagement
parts 80, 83, described above, inserter 136 is employed to secure
bone fastener 130 with extender 52 for manipulation thereof at a
surgical site.
[0087] Distal end 140 includes an enlarged portion 162 configured
to engage the minor diameter of the threads in head 132 in a
configuration to align bone fastener 130 with distal engagement
parts 80, 83. Enlarged portion 162 forces first extension 131 into
securement with distal engagement parts 80, 83 to grasp and hold
bone fastener 130 for manipulation at a surgical site. Upon
positioning and disposal of bone fastener 130, according to the
requirements of an application, grip surface 144 of handle 142 is
engaged to remove inserter 136 from passageway 64. As inserter 136
is drawn axially from passageway 64, the flexibility of arms 154,
156 allows bulge 158 to flex inwardly so that bulge 158 is released
from the frictional fit engagement with non-threaded portion
68.
[0088] The spinal rod system includes a third instrument, such as,
for example, a reducer 164, as shown in FIGS. 14-15. Reducer 164
extends between a proximal end 166 and a distal end 168. Proximal
end 166 includes a handle 172 having a grip surface 174. Handle 172
is manipulable to align reducer 164 with passageway 64. Reducer 164
is disposable in passageway 64 and defines an outer threaded
surface 176. Handle 172 is rotated such that surface 176 engages
threaded portion 66 of surface 62 to facilitate axial translation
of reducer 164 relative to extender 52 along longitudinal axis
a.
[0089] Distal end 168 includes a pusher 173 that is engageable with
a vertebral construct, such as, for example, a vertebral rod (not
shown) configured for fixation with bone fastener 130 within
U-shaped channel 160. Pusher 173 includes a cylindrical flange 174
that defines an aperture 176. Aperture 176 receives a reduced
diameter portion 178 for mounting flange 174 with a non-threaded
surface 180 of reducer 164. Flange 174 is freely slidable about
portion 178 such that pusher 173 is rotatable relative to surface
180. A retainer 182 is fixed with portion 178 to retain pusher 173
in the relatively rotatable configuration. Pusher 173 includes legs
184 having arcuate end surfaces 186 configured to engage the
vertebral rod.
[0090] Upon positioning and fixation of bone fastener 130 within
tissue at a surgical site, according to the requirements of an
application, threaded surface 176 is aligned with threaded portion
66. Handle 172 is rotated, in the direction shown by arrows E in
FIG. 14, to translate reducer 164 distally along longitudinal axis
a relative to extender 52. Reducer 164 is translated such that
arcuate end surfaces 186 engage the vertebral rod disposed in rod
slot 78 in a configuration to move the vertebral rod distally into
engagement with bone fastener 130.
[0091] Reducer 164 is further translated distally to drive the
vertebral rod into U-shaped channel 160. As reducer 164 is rotated
and translates axially, end surfaces 186 maintain alignment with
U-shaped channel 160 and reducer 164 continues to rotate relative
to pusher 173. As such, end surfaces 186 support the vertebral rod
in a guided alignment with U-shaped channel 160. Although pusher
173 is rotatable relative to reducer 164, pusher 173 is configured
to engage arm 76 to prevent rotation of pusher 173, and the
vertebral rod, relative to arm 76. This configuration maintains
alignment of the vertebral rod with U-shaped channel 160.
[0092] Handle 172 is manipulated to translate reducer 164 and drive
the vertebral rod into U-shaped channel 160 for fixation with bone
fastener 130, according to the requirements of a particular
application. Handle 172 is rotatable, in the direction shown by
arrows F in FIG. 14, to translate reducer 164 proximally such that
reducer 164 is removed from extender 52. The vertebral rod can be
fixedly secured with bone fastener 130 via a set screw (not shown)
or similar securement. It is envisioned that the spinal rod system
may include one or a plurality of extenders, inserters, reducers,
bone fasteners and/or vertebral constructs, which may be
alternately sized and dimensioned, and arranged as a kit, according
to the requirements of a particular application.
[0093] In assembly, operation and use, the spinal rod system is
employed with a surgical procedure, in accordance with the
principles of the present disclosure, for treatment of a spinal
disorder affecting a section of a spine of a patient, as discussed
herein. The spinal rod system is employed with a surgical procedure
for treatment of a condition or injury of an affected section of
the spine including vertebrae V, as shown in FIGS. 16-17, to
provide support and maximize stabilization of vertebrae V.
[0094] In use, to treat the affected section of the spine, a
medical practitioner obtains access to a surgical site including
vertebra V in any appropriate manner, such as through incision and
retraction of tissues in an open or mini-open surgical technique.
It is envisioned that the spinal rod system may be used in any
existing surgical method or technique including open surgery,
mini-open surgery and minimally invasive surgery, whereby vertebrae
V is accessed through a micro-incision, or sleeve that provides a
protected passageway to the area. Once access to the surgical site
is obtained, the particular surgical procedure is performed for
treating the spinal disorder.
[0095] The spinal rod system, described with regard to FIGS. 1-15,
including extender 52, inserter 136, reducer 164, bone fastener 130
and/or a vertebral rod 190 is then employed to augment the surgical
treatment. For example, in one embodiment, the spinal rod system
delivers and introduces implants, such as, for example, bone
fastener 130 and vertebral rod 190 at the surgical site including
vertebra V. In one embodiment, the components of the spinal rod
system are configured to position vertebral rod 190 into engagement
with bone fastener 130 for a correction treatment to treat
adolescent idiopathic scoliosis and/or Scheuennann's kyphosis. It
is contemplated that one or all of the components of the spinal rod
system can be delivered or implanted as a pre-assembled device or
can be assembled in situ. The spinal rod system may be completely
or partially revised, removed or replaced.
[0096] Pilot holes (not shown) are made bilaterally in vertebrae V1
of vertebrae V for receiving bone fasteners 130. Extenders 52 are
oriented for manipulation, alignment and capture of bone fasteners
130. Instrument release 106 of each extender 52 is manipulated
(FIG. 4) to move leg extensions 79, 82 in an outward direction
transverse to longitudinal axis a, (FIG. 3) such that distal
engagement parts 80, 83 move outwardly and are disposed in the open
position, as described above. Distal engagement parts 80, 83 are
brought into close proximity with head 132 (FIG. 9) to align tabs
124, 128 with receiving cavities 134 of first extension 131 to
provide a single sided engagement.
[0097] Instrument release 106 is manipulated such that leg
extensions 79, 82 are moved inwardly (FIG. 7) and distal engagement
parts 80, 83 are disposed in the closed position (FIG. 5). Tabs
124, 128 are received by cavities 134 of first extension 131 to
capture bone fastener 130 in releasable fixation. As described
above with regard to FIGS. 10-13, inserter 136 is disposed in
passageway 64 such that distal end 140 engages bone fastener 130 in
a configuration to support bone fastener 130 with distal engagement
parts 80, 83, as shown in FIG. 16.
[0098] Distal end 140 mates with a U-shaped channel 160. Upon
capture of bone fastener 130 with distal engagement parts 80, 83,
described above, the assembled configuration of extender 52 and
inserter 136 is employed to secure bone fastener 130 with extender
52 for manipulation thereof at a surgical site. Each assembled
configuration of extender 52 and inserter 136 is manipulated to
position bone fastener 130 with a respective pilot hole in
vertebrae V1 at the surgical site. Thereafter, handle 142 is
engaged to remove inserter 136 from passageway 64, as
described.
[0099] Threaded bone engaging portion 192 of each bone fastener 130
is inserted, drilled or otherwise fixed to vertebrae V1. Handle 172
is manipulable to align reducer 164 with passageway 64, as
described above with regard to FIGS. 14 and 15, and rotated to
translate reducer 164 distally relative to extender 52. Reducer 164
is translated such that end surfaces 186 engage vertebral rod 190
disposed in rod slot 78 in a configuration to move vertebral rod
190 distally to drive vertebral rod 190 into U-shaped channel 160.
As reducer 164 is rotated and translates axially, end surfaces 186
maintain alignment with U-shaped channel 160 and reducer 164
continues to rotate relative to pusher 173. As such, end surfaces
186 support vertebral rod 190 in a guided alignment with U-shaped
channel 160. Handle 172 is manipulated to translate reducer 164 and
drive vertebral rod 190 into U-shaped channel 160 for fixation with
bone fastener 130.
[0100] Reducer 164 is translated proximally for removal from
extender 52. Vertebral rod 190 is fixedly secured with bone
fastener 130 via a set screw (not shown) torqued onto to head 132.
Upon completion of the procedure, the surgical instruments and
assemblies are removed and the incision is closed. It is envisioned
that bone fastener 130 may be employed as a bone screw, pedicle
screw or multi-axial screw (MAS) used in spinal surgery.
[0101] In one embodiment, the spinal rod system may include
fastening elements, which may include locking structure, for
assembling, attaching or connecting the instruments. It is
envisioned that locking structure may include fastening elements
such as, for example, clips, hooks, adhesives and/or flanges. The
components of the spinal rod system can be made of radiolucent
materials such as polymers. Radiomarkers may be included for
identification under x-ray, fluoroscopy, CT or other imaging
techniques. It is envisioned that the use of microsurgical and
image guided technologies may be employed to access, view and
repair spinal deterioration or damage, with the aid of the spinal
rod system.
[0102] It is envisioned that bone fasteners 130, vertebral rod 190
and/or other implants of the spinal rod system may be coated with
biocompatible materials such as an osteoconductive material such as
(HA)-TCP and/or osteoinductive agent such as a bone morphogenic
protein (BMP) for enhanced bony fixation. It is envisioned that the
biocompatible material and/or an agent employed with an implant of
the spinal rod system may include one or more therapeutic agent(s)
disposed in one or more layers or homogenously throughout it. For
example, an implant of the spinal rod system may include at least
one agent including biocompatible materials, such as, for example,
biocompatible metals and/or rigid polymers, such as, titanium
elements, metal powders of titanium or titanium compositions,
sterile bone materials, such as allograft or xenograft materials,
synthetic bone materials such as coral and calcium compositions,
such as (HA)-TCP, calcium phosphate and calcium sulfite. It is
further envisioned that such an implant may include biologically
active agents, for example, biologically active agents coated onto
the exterior of the implant and/or applied thereto for gradual
release such as by blending in a bioresorbable polymer that
releases the biologically active agent or agents in an appropriate
time dependent fashion as the polymer degrades within the
patient.
[0103] In one embodiment, as shown in FIGS. 18 and 19, the spinal
rod system, described above, includes a pair of opposing arms 76,
each arm 76 being described in structure and operation with regard
to FIGS. 1-17. Opposing arms 76 extend uniformly and in parallel,
along longitudinal axis a. Opposing arms 76 extend distally in a
linear orientation from body 58 to define rod slot 78. Each of arms
76 includes distal engagement parts 80, 83, described above. The
engagement surfaces of distal engagement parts 80, 83 for each of
arms 76 are aligned with first extension 131 and a second extension
231 of head 132 (FIG. 9) in a configuration for disposal
circumferentially about bone fastener 130. Tabs 124, 128 are
aligned with corresponding receiving cavities 134 of extensions
131, 231 to provide a dual sided engagement. Tabs 124 are received
by cavities 134 of extensions 131, 231 such that extender 52
surrounds and captures bone fastener 130 in a releasable fixation.
It is envisioned that extender 52 may include one or a plurality of
arms 76 extending therefrom, variously disposed about longitudinal
axis a.
[0104] In one embodiment, as shown in FIGS. 20-38, the spinal rod
system, similar to that described above, includes a first
instrument, such as, for example, an extender 252 that extends
along a longitudinal axis a between a proximal portion 254 and a
distal portion 256. Proximal portion 254 includes a tubular body
258 having a cylindrical cross-section configuration and a proximal
opening 260. Body 258 extends axially from opening 260. It is
contemplated that body 258 may extend from opening 260 in alternate
configurations such as, for example, those alternatives described
herein. It is further contemplated that body 258 may extend at
transverse orientations from opening 260, relative to longitudinal
axis a, for example, perpendicular and/or other angular
orientations such as acute or obtuse, co-axial and/or parallel.
[0105] Tubular body 258 includes an inner surface 262 that defines
an inner cavity, such as, for example, a passageway 264. Inner
surface 262 includes a smooth bore 266 and a groove 268. Body 258
is configured for disposal of surgical instruments to deliver one
or more implants to a surgical site, as will be described. Body 258
includes an outer surface 270. A quick release handle 272 is
mounted to outer surface 270 for engaging and releasing a reducer
264, described below. Quick release handle 272 allows for selective
engagement and disengagement of reducer 264. With quick release
handle 272 disengaged, reducer 264 is slidable proximally and
distally. With quick release handle 272 engaged, reducer 264 is
threaded to provide mechanical advantage to reduce a rod into a
bone screw head. Quick release handle 272 can be spring loaded to
allow for automatic engagement with the thread, but when depressed
it disengages the thread allowing for sliding of the reducer.
Threads of reducer 464 engage quick release handle 272 to
facilitate translation of reducer 464 relative to extender 252, as
will be described. Handle 272 includes a button 273 that extends
through an opening 275 defined in body 258 and into passageway 264.
Button 273 is depressed to adjust position of reducer 464 and
disengage reducer 464 from the threads of reducer 464. Actuation of
handle 272 allows reducer 464 to slide freely into engagement with
a vertebral construct. Inner surface 262 includes a relief 261,
configured as a cutout or interruption in inner surface 262, that
facilitates loading of reducer 464 through opening 260.
[0106] It is contemplated that the thickness defined by surfaces
262, 270 may be uniformly increasing or decreasing, or have
alternate diameter dimensions along longitudinal axis a. It is
further contemplated that all or only a portion of surfaces 262,
270 may have alternate surface configurations, such as, for
example, those alternatives described herein. It is envisioned that
body 258 may have alternate cross section configurations, such as,
for example, those alternatives described herein. It is further
envisioned that body 258 may include fastening elements such as
anchors, detents and/or openings for connection to surgical
instruments.
[0107] Distal portion 256 includes a first arm, such as, for
example a stationary arm 276 extending along longitudinal axis a
and defining at least a portion of a rod slot 278 disposed in
communication with passageway 264. Stationary arm 276 extends
distally in a linear orientation from body 258. It is contemplated
that stationary arm 276 may extend from body 258 in alternate
configurations such as, for example, those alternatives described
herein. It is further contemplated that stationary arm 276 may
extend at transverse orientations relative to longitudinal axis a,
for example, perpendicular and/or other angular orientations such
as acute or obtuse, co-axial and/or parallel.
[0108] Stationary arm 276 includes a first leg extension 279 that
extends to a hinge connection portion 380 and defines a distal
engagement part 280. Stationary arm 276 includes a second leg
extension 282 that extends a hinge connection portion 382 and
defines a distal engagement part 283. It is contemplated that leg
extensions 279, 282 may be flexible, jointed and/or
articulating.
[0109] Stationary arm 276 defines a recess 384 configured for
movable disposal of a second arm, such as, for example, a pivoting
arm 386 of extender 252. Pivoting arm 386 includes a first leg
extension 388 that extends to a hinge connection portion 390 and
defines a distal engagement part 392. Pivoting arm 386 includes a
second leg extension 394 that extends to a hinge connection portion
396 and defines a distal engagement part 398. It is contemplated
that leg extensions 388, 394 may be flexible, jointed and/or
articulating.
[0110] Stationary arm 276 is attached to pivoting arm 386 at hinge
connection portions 390, 396. Pivoting arm 386 is pivotable
relative to stationary arm 276 such that pivoting arm 386 rotates
to surround and capture bone fastener 130 with stationary arm 276
in a releasable fixation to provide a dual sided engagement.
Pivoting arm 386 is pivotable to a closed position (FIG. 21) such
that leg extensions 388, 394 and distal engagement parts 392, 398
rotate in the direction shown by arrows AA in FIG. 21. Leg
extensions 388, 394 and distal engagement parts 392, 398, rotate
about hinge connection portions 390, 396 and relative to stationary
arm 276 such that distal engagement parts 392, 398 surround and
capture bone fastener 130 with distal engagement parts 280, 283 in
a releasable fixation to provide a dual sided engagement.
[0111] Pivoting arm 386 is pivotable to an open position (FIG. 20)
such that leg extensions 388, 394 and distal engagement parts 392,
398, rotate in the direction shown by arrows BB in FIG. 20. Leg
extensions 388, 394 and distal engagement parts 392, 398, rotate
about hinge connection portions 390, 396 and relative to stationary
arm 276 such that distal engagement parts 392, 398 and 280, 283
release bone fastener 130.
[0112] To facilitate pivotal movement of pivoting arm 386 and
rotation of pivoting arm 386 relative to stationary arm 276,
stationary arm 276 includes retaining bores 284 and pivoting arm
386 includes retaining bores 286 that receive retainers 288.
Retainers 288 connect stationary arm 276 with pivoting arm 284 to
prevent pivoting of pivoting arm 386 relative to stationary arm
276. Retainers 288 include biasing members, such as, for example,
springs for a spring loaded configuration with an instrument
release 406. Instrument release 406 is manipulable axially to
dispose stationary arm 276 and pivoting arm 284 in the open and
closed positions. Grooves 407 facilitate access to and manipulation
of instrument release 406 between the open and closed
positions.
[0113] To facilitate pivotal movement of pivoting arm 386 and
rotation of pivoting arm 386 relative to stationary arm 276,
stationary arm 276 includes spring bores 408 and pivoting arm 386
includes spring bores 410 that support biasing members, such as,
for example, springs (not shown). The springs are configured to
facilitate rotation of pivoting arm 386 via engagement therewith.
Pivoting arm 386 includes grooves 412 and stationary arm 276
includes grooves 414 that are manipulable to dispose stationary arm
276 and pivoting arm 386 in the closed position. As grooves 412,
414 are manipulated to close pivoting arm 386, retainers 288 engage
cam surfaces 416 of pivoting arm 386 to actuate retainers 288 and
the springs disposed in bores 408, 410. Pivoting arm 386 includes a
sterilization and cleaning port 418. Pivoting arm 386 includes a
relief 420 that facilitates loading of reducer 264, similar to
relief 261 described above.
[0114] Distal engagement part 280 includes an engagement surface
421 for engaging and capturing bone fastener 130, as shown in FIG.
21. Engagement surface 421 includes an arcuate surface 422
configured to contour and conform to bone faster 130 to facilitate
attachment thereto. Engagement surface 421 includes a tab 424 that
engages and is received by cavity 134 (FIG. 9) of bone fastener 130
to facilitate releasable fixation of extender 252 with bone
fastener 130.
[0115] Distal engagement part 283 includes an engagement surface
423 for engaging and capturing bone fastener 130. Engagement
surface 423 includes an arcuate surface 426 configured to contour
and conform to bone faster 130 to facilitate attachment thereto.
Engagement surface 423 includes a tab 428 that engages and is
received by cavity 134 of bone fastener 130 to facilitate
releasable fixation of extender 252 with bone fastener 130.
[0116] Distal engagement part 392 includes an engagement surface
430 for engaging and capturing bone fastener 130. Engagement
surface 430 includes an arcuate surface 432 configured to contour
and conform to bone faster 130 to facilitate attachment thereto.
Engagement surface 430 includes a tab 434 that engages and is
received by cavity 134 of bone fastener 130 to facilitate
releasable fixation of extender 252 with bone fastener 130.
[0117] Distal engagement part 398 includes an engagement surface
436 for engaging and capturing bone fastener 130. Engagement
surface 436 includes an arcuate surface 438 configured to contour
and conform to bone faster 130 to facilitate attachment thereto.
Engagement surface 436 includes a tab 440 that engages and is
received by cavity 134 of bone fastener 130 to facilitate
releasable fixation of extender 252 with bone fastener 130. This
configuration of extender 252 provides a dual sided engagement with
bone fastener 130.
[0118] In operation of the spinal rod system, extender 252 is
oriented for manipulation such that distal engagement parts 392,
398 and 280, 283 are brought into close proximity with a head 132
(FIG. 9) of a bone fastener 130. Engagement surfaces 421, 423, 430,
436 are aligned with extensions 131, 231 of head 132. Tabs 424,
428, 434, 440 are aligned with corresponding receiving cavities 134
of extensions 131, 231 to provide a dual sided engagement.
[0119] Instrument release 406 is biased distally by springs on bore
284. It is contemplated that instrument release 406 is permanently
connected, such as, for example, by welding, to retainers 288,
which are biased by springs in the closed position so instrument
release 406 is automatically biased to the closed position. From
the open position, grooves 412, 414 are manipulated to move arm 386
to the closed position. The springs are compressed such that
retainers 288 engage and move along cam surface 416. Retainers 288
move into retainer bores 286 under spring load. Pivoting arm 386 is
pivoted to the closed position and releasably fixed therein such
that tabs 424, 428, 434, 440 are received by cavities 134. Distal
engagement parts 392, 398 and 280, 283 are disposed in the closed
position, as shown in FIG. 21, such that extender 252 surrounds and
captures bone fastener 130 in a releasable fixation. To move arm
386 to the open position, instrument release 406 is engaged and
manipulated, in the direction shown by arrow CC in FIG. 21, to
disengage bone fastener 130.
[0120] The spinal rod system includes a second instrument, such as,
for example, such as, for example, a reducer 464, as shown in FIGS.
32-37. Reducer 464 extends between a proximal end 466 and a distal
end 468. Proximal end 466 includes a handle 472 having a grip
surface 474. Handle 472 is manipulable to align reducer 464 with
passageway 264. Handle 472 includes a socket cavity 471 for
engagement with a tool for rotation thereof. Reducer 464 is
disposable in passageway 464 and defines an outer threaded surface
476. Handle 472 is rotated such that surface 476 engages threaded
portion 266 of surface 262 to facilitate axial translation of
reducer 464 relative to extender 252 along longitudinal axis a.
[0121] Distal end 468 includes a pusher 473 that is engageable with
a vertebral construct, such as, for example, vertebral rod 490
(FIG. 38) configured for fixation with bone fastener 130 within
U-shaped channel 160. Pusher 473 includes a cylindrical flange 474
that defines an aperture 476. Aperture 476 receives a reduced
diameter portion 478 for mounting flange 474 with a non-threaded
surface 480 of reducer 464. Flange 474 is freely slidable about
portion 478 such that pusher 473 is rotatable relative to surface
480. A retainer 482 is fixed with portion 478 to retain pusher 473
in the relatively rotatable configuration. Pusher 473 includes legs
484 having arcuate end surfaces 486 configured to engage vertebral
rod 490.
[0122] Upon positioning and fixation of bone fastener 130 within
tissue at a surgical site, according to the requirements of an
application, threaded surface 476 is aligned with threaded portion
266. Handle 472 is rotated, in the direction shown by arrows DD in
FIG. 38, to translate reducer 464 distally along longitudinal axis
a relative to extender 252. Reducer 464 is translated such that
arcuate end surfaces 486 engage vertebral rod 490 disposed in rod
slot 278 in a configuration to move vertebral rod 490 distally into
engagement with bone fastener 130.
[0123] Reducer 464 is further translated distally to drive
vertebral rod 490 into U-shaped channel 160 (FIG. 9). As reducer
464 is rotated and translates axially, end surfaces 486 maintain
alignment with U-shaped channel 160 and reducer 464 continues to
rotate relative to pusher 473. As such, end surfaces 486 support
vertebral rod 490 in a guided alignment with U-shaped channel 160.
Although pusher 473 is rotatable relative to reducer 464, pusher
473 is configured to engage arms 276, 386 to prevent rotation of
pusher 473, and vertebral rod 490, relative to arms 276, 386. This
configuration maintains alignment of vertebral rod 490 with
U-shaped channel 160.
[0124] Handle 472 is manipulated to translate reducer 464 and drive
vertebral rod 490 into U-shaped channel 160 for fixation with bone
fastener 130, according to the requirements of a particular
application. Handle 472 is rotatable, in the direction shown by
arrows EE in FIG. 38, to translate reducer 464 proximally such that
reducer 464 is removed from extender 252. Vertebral rod 490 can be
fixedly secured with bone fastener 130 via a set screw (not shown)
or similar securement. It is envisioned that the spinal rod system
employing extender 252 may include one or a plurality of extenders,
inserters, reducers, bone fasteners and/or vertebral constructs,
which may be alternately sized and dimensioned, and arranged as a
kit, according to the requirements of a particular application. It
is further envisioned that the spinal rod system employing extender
252 may be used with various surgical procedures, such as, for
example, those described herein.
[0125] In one embodiment, as shown in FIGS. 39-41, the spinal rod
system, similar to that described with regard to FIGS. 20-38,
includes a first instrument, such as, for example, an extender 552
that extends along a longitudinal axis a between a proximal portion
554 and a distal portion 556. Proximal portion 554 includes a
tubular body 558 having a cylindrical cross-section configuration
and a proximal opening 560. Tubular body 558 includes an inner
surface 562, similar to extender 252 described above, which defines
a passageway 564 and includes a quick release handle 572.
[0126] Distal portion 556 includes a stationary arm 576 extending
along longitudinal axis a and defining at least a portion of a rod
slot 578 (FIG. 41) disposed in communication with passageway 564.
Stationary arm 576 includes a single leg extension 579 that extends
to a hinge connection portion and defines a distal engagement part
580. It is contemplated that leg extension 579 may be flexible,
jointed and/or articulating.
[0127] Stationary arm 576 defines a recess 584 configured for
movable disposal of a second arm, such as, for example, a pivoting
arm 586 of extender 552. Pivoting arm 586 includes a single leg
extension 588 that extends to a hinge connection portion and
defines a distal engagement part 592. It is contemplated that leg
extension 588 may be flexible, jointed and/or articulating.
[0128] Stationary arm 576 is attached to pivoting arm 586 at the
hinge connection portions of leg extensions 579, 588. Pivoting arm
586 is pivotable relative to stationary arm 576 such that pivoting
arm 586 rotates to capture bone fastener 130 with stationary arm
576 in a releasable fixation to provide a single sided engagement.
Pivoting arm 586 is pivotable to a closed position (FIG. 40) such
that leg extension 588 and distal engagement part 592 rotate in the
direction shown by arrows AAA in FIG. 39. Leg extension 588 and
distal engagement part 592 rotate about the hinge connection
portions and relative to stationary arm 576 such that distal
engagement part 592 captures bone fastener 130 with distal
engagement part 580 in a releasable fixation to provide a single
sided engagement.
[0129] Pivoting arm 586 is pivotable to an open position (FIG. 39)
such that leg extension 588 and distal engagement part 592 rotate
in the direction shown by arrows BBB in FIG. 39. Leg extension 588
and distal engagement part 592 rotate about the hinge connection
portions and relative to stationary arm 576 such that distal
engagement parts 592, 580 release bone fastener 130. Pivotal
movement of pivoting arm 586 and rotation of pivoting arm 586
relative to stationary arm 576 is configured for single sided
capture and facilitated by biasing members, retainers and
instrument release components, similar to the structure and
operation described with regard to extender 252 described with
regard to FIGS. 20-38.
[0130] In operation of the spinal rod system, extender 552 is
oriented for manipulation such that distal engagement parts 592,
580, similar to the distal engagement parts described above, are
brought into close proximity and aligned with head 132 of bone
fastener 130. The tabs of distal engagement parts 592, 580 are
aligned with corresponding receiving cavities 134 of first
extension 131 to provide a single sided engagement.
[0131] Instrument release 506 is automatically biased to the closed
position, and arms 576, 586 are manipulated such that pivoting arm
586 is moved to the closed position, similar to that described with
regard to FIGS. 20-38, such that the tabs of distal engagement
parts 592, 580 are received by cavities 134. Distal engagement
parts 592, 580 are disposed in the closed position, as shown in
FIG. 40, such that extender 552 captures bone fastener 130 in a
releasable fixation. To move arm 586 to the open position,
instrument release 506 is engaged and manipulated, in the direction
shown by arrow CCC in FIG. 41, to disengage bone fastener 130.
[0132] Reducer 464, as described with regard to FIGS. 32-37, is
aligned with passageway 564. Handle 472 is rotated to translate
reducer 464 distally along longitudinal axis a relative to extender
552, as shown in FIG. 41. Reducer 464 is translated such that
arcuate end surfaces 486 engage vertebral rod 490 disposed in rod
slot 578 in a configuration to move vertebral rod 490 distally into
engagement with bone fastener 130.
[0133] Reducer 464 is further translated distally to drive
vertebral rod 490 into U-shaped channel 160. As reducer 464 is
rotated and translates axially, end surfaces 486 maintain alignment
with U-shaped channel 160 and reducer 464 continues to rotate
relative to pusher 473. As such, end surfaces 486 support vertebral
rod 490 in a guided alignment with U-shaped channel 160. Although
pusher 473 is rotatable relative to reducer 464, pusher 473 is
configured to engage arms 576, 586 to prevent rotation of pusher
473 and vertebral rod 490, relative to arms 576, 586. This
configuration maintains alignment of vertebral rod 490 with
U-shaped channel 160.
[0134] Handle 472 is manipulated to translate reducer 464 and drive
vertebral rod 490 into U-shaped channel 160 for fixation with bone
fastener 130, according to the requirements of a particular
application. Handle 472 is rotatable to translate reducer 464
proximally such that reducer 464 is removed from extender 552.
Vertebral rod 490 can be fixedly secured with bone fastener 130 via
a set screw (not shown) or similar securement. It is envisioned
that the spinal rod system employing extender 552 may include one
or a plurality of extenders, inserters, reducers, bone fasteners
and/or vertebral constructs, which may be alternately sized and
dimensioned, and arranged as a kit, according to the requirements
of a particular application. It is further envisioned that the
spinal rod system employing extender 552 may be used with various
surgical procedures, such as, for example, those described
herein.
[0135] In one embodiment, as shown in FIG. 42, the spinal rod
system, similar to that described above, includes a lateral
translation handle 602 mounted with extender 552, as described with
regard to FIGS. 39-41. Handle 602 is pivotally attached with body
558 and has a grip surface 604 for manipulation thereof. Handle 602
extends to an engagement member 606 configured to capture vertebral
rod 490. Grip surface 604 is manipulable to rotate engagement
member 606, in the direction shown by arrows Z, to engage and
capture vertebral rod 490. Engagement member 606 guides vertebral
rod 490 into rod slot 578.
[0136] In one embodiment, as shown in FIGS. 43-47, the spinal rod
system, similar to that described above, includes a quick release
locking system 702, similar the quick release handle described with
regard to FIGS. 20-38. Quick release locking system 702 includes a
locking element 704, which is mounted with an outer surface of
extender 252 (FIGS. 20-38) for engaging and releasing a reducer 264
(FIGS. 32-37). The inner surface of extender 252, for the purposes
of this embodiment, is non-threaded and the threads of reducer 264
do not engage such inner surface to facilitate axial translation
thereof.
[0137] Locking element 704, as shown in FIG. 45, includes enlarged
end portions 706 configured to engage the outer surface of extender
252 for mounting therewith. End portions 706 are connected by a
cylindrical shaft 708 that defines a circumferential outer surface
710. Outer surface 710 defines a centrally disposed notch 712
extending about only a quadrant of the entire circumferential outer
surface 710. Notch 712 has a concave configuration such that the
remaining portion of surface 710 is arcuate. Notch 712 provides an
interruption within the uniformity of outer surface 710.
[0138] Locking element 704 is rotatable between a disengaged
position of quick release locking system 702 (FIGS. 43-44) and an
engaged position of quick release locking system 702 (FIGS. 46-47).
In the disengaged position, notch 712 is aligned with the threads
of reducer 464 such that reducer 464 is not disposed in a mating,
threaded engagement shaft 708. Reducer 464 can slide freely into
engagement with vertebral rod 490. In the engaged position, end
portions 706 are manipulated and rotated relative to extender 252,
such that shaft 708 is rotated a quarter turn and notch 712 is
rotated out of alignment with the threads of reducer 464. At least
a portion of the remaining circumferential portion of surface 710
is aligned with the threads of reducer 464. As such, the threads of
reducer 464 are disposed in a mating, threaded engagement shaft
708. Rotation of reducer 464 facilitates translation of reducer 464
relative to extender 252, as described.
[0139] It will be understood that various modifications may be made
to the embodiments disclosed herein. Therefore, the above
description should not be construed as limiting, but merely as
exemplification of the various embodiments. Those skilled in the
art will envision other modifications within the scope and spirit
of the claims appended hereto.
* * * * *