U.S. patent application number 14/631492 was filed with the patent office on 2016-08-25 for surgical instrument and method.
The applicant listed for this patent is Warsaw Orthopedic, Inc.. Invention is credited to Jason M. May, Joshua W. Simpson.
Application Number | 20160242825 14/631492 |
Document ID | / |
Family ID | 56690162 |
Filed Date | 2016-08-25 |
United States Patent
Application |
20160242825 |
Kind Code |
A1 |
Simpson; Joshua W. ; et
al. |
August 25, 2016 |
SURGICAL INSTRUMENT AND METHOD
Abstract
A surgical instrument comprises a first member including a
lateral projection having a locking surface that defines an
elongated cavity. The locking surface is engageable with a
longitudinal member to fix the longitudinal member with the first
member. A second member includes at least one mating element being
engageable with a spinal construct. The first member is axially
translatable relative to the second member in a first direction to
tension the longitudinal member and in a second direction to
release tension from the longitudinal member. Systems and methods
are disclosed.
Inventors: |
Simpson; Joshua W.;
(Collierville, TN) ; May; Jason M.; (Cordova,
TN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Warsaw Orthopedic, Inc. |
Warsaw |
IN |
US |
|
|
Family ID: |
56690162 |
Appl. No.: |
14/631492 |
Filed: |
February 25, 2015 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/842 20130101;
A61B 17/7053 20130101; A61B 17/7076 20130101; A61B 17/8869
20130101; A61B 2017/00004 20130101; A61B 17/7034 20130101 |
International
Class: |
A61B 17/70 20060101
A61B017/70 |
Claims
1. A surgical instrument comprising: a first member including a
lateral projection having a locking surface that defines an
elongated cavity, the locking surface being engageable with a
longitudinal member to fix the longitudinal member with the first
member; and a second member including at least one mating element
being engageable with a spinal construct, wherein the first member
is axially translatable relative to the second member in a first
direction to tension the longitudinal member and in a second
direction to release tension from the longitudinal member.
2. A surgical instrument as recited in claim 1, wherein the first
member includes an actuator configured to cause axial translation
of the first member relative to the second member.
3. A surgical instrument as recited in claim 1, wherein the first
member includes a rotatable actuator that axially translates the
first member relative to the second member.
4. A surgical instrument as recited in claim 1, wherein the first
member is threaded with the second member.
5. A surgical instrument as recited in claim 4, wherein the second
member includes a threaded shaft configured for engagement with the
first member to facilitate axial translation.
6. A surgical instrument as recited in claim 1, wherein the lateral
projection includes a flat profile.
7. A surgical instrument as recited in claim 1, wherein the lateral
projection includes a slot with a tapered portion configured to
receive the longitudinal member.
8. A surgical instrument as recited in claim 1, wherein the lateral
projection includes a flange.
9. A surgical instrument as recited in claim 1, wherein the second
member includes at least one arm having at least one mating element
configured to engage the spinal construct.
10. A surgical instrument as recited in claim 1, wherein the second
member includes a first arm and a second arm, the arms each
including a mating element configured to engage the spinal
construct.
11. A surgical instrument as recited in claim 10, wherein the first
arm is connected with the second arm via a pivot to facilitate
relative rotation of the arms.
12. A surgical instrument as recited in claim 1, wherein the second
member includes a first arm, a second arm and a lock to fix the
first arm relative to the second arm.
13. A surgical instrument as recited in claim 12, wherein the
second arm includes a notch configured to engage the lock.
14. A surgical instrument as recited in claim 12, wherein the
second arm includes a barb configured to limit movement of the
lock.
15. A method for treating a spine, the method comprising the steps
of: providing a connector configured for disposal of a spinal rod;
providing a surgical instrument being engageable with the connector
and including a projection having a locking surface; disposing a
tether with the connector; folding the tether about the projection;
engaging a portion of the tether with the locking surface to fix
the tether with the surgical instrument; and selectively
translating the projection to tension the tether.
16. A method for treating a spine as recited in claim 15, wherein
the projection extends laterally from the surgical instrument and
the step of folding includes wrapping the tether around the
projection.
17. A method for treating a spine as recited in claim 15, wherein
the locking surface defines an elongated cavity configured for
disposal of the portion.
18. A method for treating a spine as recited in claim 15, wherein
the step of selectively translating includes axially translating
the projection in a first direction to tension the tether and in a
second direction to release tension from the tether.
19. A method for treating a spine as recited in claim 15, wherein
the surgical instrument includes arms that are relatively movable
for engaging the connector between an open orientation and a closed
orientation for capturing the connector.
20. A surgical system comprising: a first member including a
lateral projection having a locking surface that defines an
elongated cavity, the locking surface and a second member including
at least one mating element being engageable with a spinal
construct; a flexible tether extending between a first end and a
second end configured for engagement with the lateral projection; a
connector configured for engagement with the first end of the
tether the at least one mating element; and a spinal rod configured
for disposal with the connector, wherein the first member is
axially translatable relative to the second member in a first
direction to tension the tether and in a second direction to
release tension from the tether.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims the benefits of U.S. Provisional
Patent Application Ser. No. 61/951,416 (Attorney Docket No.
C00007324.USP1) filed Mar. 11, 2014, the contents of which being
hereby incorporated in its entirety by reference.
TECHNICAL FIELD
[0002] The present disclosure generally relates to medical devices
for the treatment of musculoskeletal disorders, and more
particularly to a surgical system and method for correction of a
spine disorder.
BACKGROUND
[0003] Spinal pathologies and disorders such as scoliosis and other
curvature abnormalities, kyphosis, degenerative disc disease, disc
hemiation, 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.
[0004] 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 implants,
such as vertebral rods, bone screws and sub-laminar wire, for
stabilization of a treated section of a spine. This disclosure
describes an improvement over these prior art technologies.
SUMMARY
[0005] In one embodiment, a surgical instrument comprises a first
member including a lateral projection having a locking surface that
defines an elongated cavity. The locking surface is engageable with
a longitudinal member to fix the longitudinal member with the first
member. A second member includes at least one mating element being
engageable with a spinal construct. The first member is axially
translatable relative to the second member in a first direction to
tension the longitudinal member and in a second direction to
release tension from the longitudinal member. In some embodiments,
systems and methods are disclosed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] The present disclosure will become more readily apparent
from the specific description accompanied by the following
drawings, in which:
[0007] FIG. 1 is a perspective view of one embodiment of components
of a surgical system in accordance with the principles of the
present disclosure;
[0008] FIG. 2 is a side view of the components shown in FIG. 1;
[0009] FIG. 3 is a break away view of the components shown in FIG.
1;
[0010] FIG. 4 is a break away view of the components shown in FIG.
1;
[0011] FIG. 5 is a break away view of the components shown in FIG.
1;
[0012] FIG. 6 is a cross section view of the components shown in
FIG. 5;
[0013] FIG. 7 is a break away view of the components shown in FIG.
1;
[0014] FIG. 8 is a break away view of the components shown in FIG.
1;
[0015] FIG. 9 is a side view of the components shown in FIG. 1;
[0016] FIG. 10 is a perspective view of the components shown in
FIG. 1;
[0017] FIG. 11 is a side view of one embodiment of components of a
surgical system in accordance with the principles of the present
disclosure;
[0018] FIG. 12 is a side view of the components shown in FIG.
11;
[0019] FIG. 13 is a break away view of one embodiment of components
of a surgical system in accordance with the principles of the
present disclosure disposed with vertebrae;
[0020] FIG. 14 is a break away view of the components and vertebrae
shown in FIG. 13;
[0021] FIG. 15 is a break away view of the components and vertebrae
shown in FIG. 13; and
[0022] FIG. 16 is a perspective view of the components and
vertebrae shown in FIG. 13.
DETAILED DESCRIPTION
[0023] The exemplary embodiments of a surgical system and related
methods of use are discussed in terms of medical devices for the
treatment of musculoskeletal disorders and more particularly, in
terms of a surgical system and method for correction of a spine
disorder. In some embodiments, the surgical system may be employed
in applications for correction of deformities, such as scoliosis
and kyphosis.
[0024] In some embodiments, the surgical system includes a surgical
instrument configured to apply a tension to a sublaminar tether. In
some embodiments, the surgical system includes a tensioner
configured to apply a tension to a tether and/or a spinal
construct. In some embodiments, the tensioner is configured for
attachment with a spinal construct, such as, for example, a
connector. In some embodiments, the tensioner is configured for
attachment with the connector via mating surfaces. In some
embodiments, the mating surfaces include one or more slots. In one
embodiment, the tensioner includes a mating element for engagement
with slots disposed with the connector. In some embodiments, the
tensioner comprises an implant holder.
[0025] In some embodiments, the surgical system includes a tether
configured for engagement with the connector. In some embodiments,
the tether is passed through the connector and engaged with a
protrusion of a tensioning carriage disposed with the tensioner. In
one embodiment, the tether is wrapped around the protrusion on the
tensioning carriage. In some embodiments, an end of the tether is
disposed with a slot in an end of the protrusion to prevent the
tether from unwrapping. In some embodiments, a tension of the
tether fixes the tether with the protrusion.
[0026] In some embodiments, the surgical instrument includes a
threaded shaft to facilitate translation of a carriage in a
direction away from the connector by rotation along a threaded
shaft. In some embodiments, the surgical instrument includes a knob
to actuate translation and apply a tension to the tether.
[0027] In some embodiments, the surgical system is used with
surgical navigation, such as, for example, fluoroscope or image
guidance. In one embodiment, one or all of the components of the
surgical system are disposable, peel-pack, pre-packed sterile
devices. 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.
[0028] In one embodiment, the present disclosure may be employed to
treat spinal disorders such as, for example, degenerative disc
disease, disc hemiation, osteoporosis, spondylolisthesis, stenosis,
scoliosis and other curvature abnormalities, kyphosis, tumor and
fractures. In one embodiment, the present disclosure may be
employed with other osteal and bone related applications, including
those associated with diagnostics and therapeutics. In some
embodiments, the disclosed surgical system and methods may be
alternatively employed in a surgical treatment with a patient in a
prone, supine position, lateral and/or employ various surgical
approaches to the spine, including anterior, posterior, posterior
mid-line, direct lateral, 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, sacral 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.
[0029] The present disclosure may be understood more readily by
reference to the following detailed description of the embodiments
taken in connection with the accompanying drawing figures, which
form a part of this disclosure. It is to be understood that this
application 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. Also, in some embodiments, 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 dearly 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".
[0030] 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), employing implantable devices, and/or employing
instruments that treat the disease, such as, for example, micro
discectomy instruments used to remove portions bulging or herniated
discs and/or bone spurs, 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 indude
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.
[0031] 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 is made in
detail to exemplary embodiments of the present disclosure, which
are illustrated in the accompanying figures. Turning to FIGS. 1-12,
there are illustrated components of a surgical system, such as, for
example, a spinal correction system 10.
[0032] The components of spinal correction system 10 can be
fabricated from biologically acceptable materials suitable for
medical applications, including metals, synthetic polymers,
ceramics and bone material and/or their composites. For example,
the components of spinal correction system 10, 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 such
as hydroxyapatite (HA), corraline HA, biphasic calcium phosphate,
tricalcium phosphate, or fluorapatite, tricalcium phosphate (TCP),
HA-TCP, calcium sulfate, or other resorbable polymers such as
polyaetide, polyglycolide, polytyrosine carbonate, polycaroplaetohe
and their combinations, biocompatible ceramics, mineralized
collagen, bioactive glasses, porous metals, bone particles, bone
fibers, morselized bone chips, bone morphogenetic proteins (BMP),
such as BMP-2, BMP-4, BMP-7, rhBMP-2, or rhBMP-7, demineralized
bone matrix (DBM), transforming growth factors (TGF, e.g., TGF-3),
osteoblast cells, growth and differentiation factor (GDF),
insulin-like growth factor 1, platelet-derived growth factor,
fibroblast growth factor, or any combination thereof.
[0033] Various components of spinal correction system 10 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 spinal
correction system 10, 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
spinal correction system 10 may be monolithically formed,
integrally connected or include fastening elements and/or
instruments, as described herein.
[0034] Spinal correction system 10 comprises a surgical instrument,
such as, for example, a tensioner 12. Tensioner 12 extends between
an end 14 and an end 16. Tensioner 12 defines a longitudinal axis
X1. In some embodiments, tensioner 12 may comprise overall and/or
cross-section configurations, such as, for example, cylindrical,
round, oval, rectangular, polygonal, irregular, tapered, offset,
staggered, uniform and non-uniform. In some embodiments, one or
more of the surfaces of tensioner 12 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.
[0035] Tensioner 12 includes a member, such as, for example, a
carriage 18. Carriage 18 extends between an end 20 and an end 22.
Carriage 18 has a circular cross-sectional configuration. In some
embodiments, carriage 18 may have various configurations, for
example, cylindrical, square, oval, rectangular, polygonal,
irregular, tapered, offset, staggered and uniform. Carriage 18
includes an outer surface 24. Outer surface 24 has a smooth surface
configuration. In some embodiments, outer surface 24 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.
[0036] Carriage 18 includes a projection 30 extending laterally
from surface 24. Projection 30 includes a flat and/or even surface
profile and defines an axis X2 extending transverse to axis X1, as
shown in FIG. 2. Projection 30 includes a locking surface 32
configured for engagement with a longitudinal member, such as, for
example, a tether 130, as described herein. Locking surface 32
defines an elongated cavity, such as, for example, a slot 34. Slot
34 extends along an axis X3. In some embodiments, axis X3 is
parallel to axis X1. In some embodiments, axis X3 extends
transverse to axis X1. In one embodiment, as shown in FIG. 2, slot
34 includes a tapered portion 36 configured to receive tether 130
and provisionally fix tether 130 with projection 30. In some
embodiments, slot 34 may have various configurations, for example,
square, oval, rectangular, polygonal, irregular, offset, staggered,
uniform and non-uniform.
[0037] Projection 30 includes a flange 38 that extends along a
width of projection 30. Flange 38 is configured to form extensions
38a, 38b configured to prevent and/or limit lateral movement of
tether 130 along projection 30 to resist and/or prevent
disengagement and/or release of tether 130 from projection 30.
[0038] Carriage 18 includes an inner threaded surface 40, as shown
in FIG. 12. Surface 40 defines a translation cavity 42 that extends
through at least a portion of carriage 18. Cavity 42 extends along
longitudinal axis X1. Cavity 42 is configured for engagement and
axial translation along a threaded shaft 96 of an arm 54, as
described herein.
[0039] Carriage 18 is connected with an actuator, such as, for
example, a knob 44. In one embodiment, knob 44 is rotatable to
facilitate axial translation of carriage 18 relative to an
engagement member 50, as described herein. Knob 44 includes a
surface 46 configured to facilitate gripping and rotation. In some
embodiments, surface 46 may have alternate surface configurations,
such as, for example, grooved, rough, threaded for connection with
surgical instruments, arcuate, undulating, porous, semi-porous,
dimpled, polished and/or textured.
[0040] Tensioner 12 includes engagement member 50 connected with
carriage 18. Member 50 includes an arm 52 and an arm 54. Arm 52
extends between a proximal end 56 and a distal end 58. In some
embodiments, the cross-section of arm 52 may have various
configurations, such as, for example, round, oval, rectangular,
polygonal, irregular, tapered, offset, staggered, uniform and
non-uniform.
[0041] Arm 52 includes a surface 60 that defines a cavity 62
configured for disposal of a pin 64 of a lock 100, as described
herein. In one embodiment, cavity 62 is disposed at proximal end
56. Arms 52, 54 define an opening, such as, for example, a channel
66 configured for disposal of a hinge 68. Arm 52 is rotatable about
hinge 68 causing arm 52 to pivot relative to arm 54 to facilitate
release, capture and/or locking of a spinal construct, such as, for
example, a connector 140, as described herein, with engagement
member 50. Hinge 68 is centrally disposed on arms 52, 54 and
configured to facilitate rotation of arm 52 relative to arm 54. In
some embodiments, hinge 68 may be variously configured, such as,
for example, a pin, post, screw, living hinge, ratchet and/or
concentric parts.
[0042] Arm 52 includes a surface 70 that defines a capture element,
such as, for example, an elongated tab 72. Tab 72 is configured to
engage connector 140. Surface 70 defines a portion of an engagement
cavity 74 of tensioner 12. In some embodiments, surface 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.
[0043] Arm 54 extends between a proximal end 80 and a distal end
82. In some embodiments, the cross-section of arm 54 may have
various configurations, such as, for example, round, oval,
rectangular, polygonal, irregular, tapered, offset, staggered,
uniform and non-uniform.
[0044] Arm 54 includes a surface 84. Surface 84 defines an
engagement portion that includes a notch 86 and barbs 88. Notch 86
is configured for engagement with a pin 114 of lock 100 to fix arm
52 relative to arm 54, as described herein. Barbs 88 are disposed
distally from notch 86 and are configured to limit movement of lock
100 to prevent arms 52, 54 from pivoting beyond a selected distance
causing disengagement from connector 140. Pin 114 translates from
engagement with notch 86 along surface 84 to engage barbs 88 to
facilitate pivoting of arm 52 relative to arm 54. In some
embodiments, pin 114 translates from engagement with notch 86 along
surface 84 such that arm 52 and/or arm 54 bend and/or flex as pin
114 translates over rounded surface 85, as shown in FIG. 8. This
configuration provides a snap and/or over-center mechanism of lock
100.
[0045] Arm 54 includes a surface 92 that defines a capture element,
such as, for example, an elongated tab 94. Tab 94 is configured to
engage connector 140. Surface 92 defines a portion of engagement
cavity 74 of tensioner 12. In some embodiments, surface 92 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.
[0046] Arm 54 includes a threaded shaft 96 extending from end 80
configured for engagement with carriage 18 to facilitate
translation of carriage 18 relative to engagement member 50.
Translation of carriage 18 relative to engagement member 50 in a
direction opposite to connector 140 causes an increase in tension
and/or tensile force in tether 130, as described herein.
Translation of carriage 18 relative to engagement member 50 in a
direction towards connector 140 causes a release of and/or decrease
in tension and/or tensile force in tether 130.
[0047] Tensioner 12 includes lock 100. Lock 100 includes extensions
102, 104. Extensions 102, 104 form a cavity 106 for moveable
disposal of arms 52, 54. Extension 102 includes a surface 110 that
defines a cavity 112 configured for disposal of pin 64. Extension
104 defines a cavity (not shown), similar to cavity 112, configured
for disposal of pin 64. Pin 64 extends between extensions 102, 104
through cavity 62 of arm 52. Rotation of pin 64 facilitates
pivoting of arm 52 relative to arm 54.
[0048] Surface 110 defines a cavity 116 configured for disposal of
a pin 114. Extension 104 defines a cavity 120 configured for
disposal of pin 114. Pin 114 extends between extensions 102, 104
and is disposed within cavity 106. Translation of pin 114 along the
engagement portion of arm 54 causes lock 100 to move from notch 86
to barbs 88. This configuration facilitates movement of arms 52, 54
between an open orientation of tensioner 12, as shown in FIG. 10,
such that arms 52, 54 are configured to receive and/or release a
spinal construct, such as, for example, connector 140, and a dosed
orientation of tensioner 12, as shown in FIG. 9, such that arms 52,
54 capture connector 140. In the closed orientation, arms 52, 54
are releasably and/or provisionally fixed with connector 140, as
shown in FIG. 1. In some embodiments, arms 52, 54 are resiliently
biased to the open orientation via a biasing member, such as, for
example, a spring 53. In some embodiments, the biasing member can
include an elastic band, spring dip, telescoping shafts, resilient
hinge or living hinge. In some embodiments, arms 52, 54 are not
biased and manually manipulable to the orientations, as described
herein.
[0049] Lock 100 includes an actuator, such as, for example, a tab
122 configured to facilitate translation of lock 100 along the
engagement portion of arm 54 to dispose tensioner 12 between an
open orientation and a closed orientation, as described herein. In
some embodiments, the lock comprises a latch, and/or the arms
include mating elements for engagement and capture of an implant.
See also, the examples and disclosure of systems, surgical
instruments, latches, arms, mating elements and methods shown and
described in U.S. Provisional Patent Application No. Ser. No.
61/951,416 (Attorney Docket No. C00007324.USP1) filed Mar. 11,
2014, the contents of which being hereby incorporated in its
entirety by reference.
[0050] Spinal correction system 10 includes a longitudinal member,
such as, for example, a tether 130. Tether 130 is a flexible
longitudinal element that extends between an end 132 and an end
134. Tether 130 is configured for engagement with connector 140, as
described herein. In some embodiments, end 132 and end 134 form a
loop configured to surround all or a portion of tissue, such as,
for example, laminae and/or a spinal implant, such as, for example,
a spinal rod 170, as described herein. Tether 130 is configured for
tensioning about a targeted portion of an anatomy of a body for
attachment of tether 130 with the targeted portion of the anatomy,
as described herein. In some embodiments, the targeted portion of
the anatomy may include laminae, transverse process and/or pedicle
regions of a vertebral level. In some embodiments, spinal
correction system 10 may include one or a plurality of tethers 130,
each tether being configured for disposal about a single and
separate vertebral level. In some embodiments, a single vertebral
level may include one or a plurality of tethers 130.
[0051] Tether 130 has a flexible configuration and may be
fabricated from materials, such as, for example, fabric, silicone,
polyurethane, silicone-polyurethane copolymers, polymeric rubbers,
polyolefin rubbers, elastomers, rubbers, thermoplastic elastomers,
thermoset elastomers and elastomeric composites. In one embodiment,
the flexibility of tether 130 includes movement in a lateral or
side to side direction and prevents expanding and/or extension in
an axial direction upon tensioning and attachment with a targeted
portion of the anatomy. In some embodiments, all or only a portion
of tether 130 may have a semi-rigid, rigid or elastic
configuration, and/or have elastic properties, similar to the
material examples described above, such that tether 130 provides a
selective amount of expansion and/or extension in an axial
direction. In some embodiments, tether 130 may be compressible in
an axial direction. Tether 130 can include a plurality of
separately attachable or connectable portions or sections, such as
bands or loops, or may be monolithically formed as a single
continuous element.
[0052] Tether 130 can have a uniform thickness/diameter. In some
embodiments, tether 130 may have various surface configurations,
such as, for example, smooth and/or surface configurations to
enhance fixation, such as, for example, rough, arcuate, undulating,
porous, semi-porous, dimpled, polished and/or textured. In some
embodiments, the thickness defined by tether 130 may be uniformly
increasing or decreasing, or have alternate diameter dimensions
along its length. In some embodiments, tether 130 may have various
cross section configurations, such as, for example, oval, oblong,
triangular, rectangular, square, polygonal, irregular, uniform,
non-uniform, variable and/or tapered. In some embodiments, the
surface of tether 130 may include engaging structures, such as, for
example, barbs, raised elements and/or spikes to facilitate
engagement with tissue of the targeted anatomy.
[0053] In some embodiments, tether 130 may have various lengths. In
some embodiments, tether 130 may be braided, such as a rope, or
include a plurality elongated elements to provide a predetermined
force resistance. In some embodiments, tether 130 may be made from
autograft and/or allograft, and be configured for resorbable or
degradable applications. In one embodiment, tether 130 is a cadaver
tendon. In one embodiment, tether 130 is a tendon that may be
harvested, for example, from a patient or donor. In some
embodiments, a tendon harvested from a patient may be affixed in
remote locations with the patient's body.
[0054] Spinal correction system 10 includes connector 140.
Connector 140 includes a body 142 having a surface 144 that defines
a cavity, such as, for example, a passageway 146 configured for
disposal of tether 130. In some embodiments, passageway 146 may
have various cross section configurations, such as, for example,
oval, oblong, triangular, rectangular, square, polygonal,
irregular, uniform, non-uniform, variable and/or tapered. In some
embodiments, surface 144 may include gripping elements or surfaces,
such as, for example, rough, arcuate, undulating, mesh, porous,
semi-porous, dimpled and/or textured to facilitate engagement with
tether 130.
[0055] Body 142 includes a surface 148 defining a cavity 150
configured for disposal of tether 130. In some embodiments, cavity
150 is disposed in alignment, offset or staggered from passageway
146. In some embodiments, opening 150 may have various cross
section configurations, such as, for example, oval, oblong,
triangular, rectangular, square, polygonal, irregular, uniform,
non-uniform, variable and/or tapered. In some embodiments, surface
148 may include gripping elements or surfaces, such as, for
example, rough, arcuate, undulating, mesh, porous, semi-porous,
dimpled and/or textured to facilitate engagement with tether 130.
Body 142 includes a surface 152 that defines a cavity, such as, for
example, an opening 154. Opening 154 is configured for disposal of
a coupling member, such as, for example, a set screw 156 (FIG.
13).
[0056] Body 142 includes a surface 160 that defines a passageway
162. Passageway 162 has an oblong configuration and extends through
the body. In some embodiments, passageway 162 may have alternate
cross section configurations, such as, for example, oval,
cylindrical, triangular, square, polygonal, irregular, uniform,
non-uniform, offset, staggered, undulating, arcuate, variable
and/or tapered. Passageway 162 is configured for disposal of spinal
rod 170 such that connector 140 can be mounted with spinal rod 170,
as described herein.
[0057] Body 142 includes a mating surface 164 that defines
cavities, such as, for example, mating slots configured to mate
with tabs 72, 94 to facilitate connection of tensioner 12 with
connector 140, as described herein. In some embodiments, spinal
correction system 10 may include one or a plurality of implant
connectors spaced apart and disposed along a spinal implant, such
as, for example, spinal rod 170, which may be relatively disposed
in a side by side, irregular, uniform, non-uniform, offset and/or
staggered orientation or arrangement, along one or a plurality of
spinal rods. In some embodiments, spinal rod 170 extends along one
or a plurality of vertebra, as described herein. In some
embodiments, spinal correction system 10 may include one or a
plurality of spinal rods 170, which may be relatively disposed in a
side by side, irregular, uniform, non-uniform, offset and/or
staggered orientation or arrangement.
[0058] In assembly, operation and use, spinal correction system 10,
similar to the systems and methods described herein, is employed
with a surgical procedure, such as, for example, a correction
treatment of an affected portion of a spine, for example, a
correction treatment to treat adolescent idiopathic scoliosis
and/or Scheuermann's kyphosis of a spine. In some embodiments, one
or all of the components of spinal correction system 10 can be
delivered or implanted as a pre-assembled device or can be
assembled in situ. Spinal correction system 10 may be completely or
partially revised, removed or replaced.
[0059] In use, to treat a selected section of vertebrae V, as shown
in FIGS. 13-16, a medical practitioner obtains access to a surgical
site including vertebrae V in any appropriate manner, such as
through incision and retraction of tissues. In some embodiments,
spinal correction system 10 can be used in any existing surgical
method or technique including open surgery, mini-open surgery,
minimally invasive surgery and percutaneous surgical implantation,
whereby vertebrae V is accessed through a mini-incision, or a
sleeve that provides a protected passageway to the area. Once
access to the surgical site is obtained, the particular surgical
procedure can be performed for treating the spine disorder.
[0060] An incision is made in the body of a patient and a cutting
instrument (not shown) creates a surgical pathway for implantation
of components of spinal correction system 10. A preparation
instrument (not shown) can be employed to prepare tissue surfaces
of vertebrae V, as well as for aspiration and irrigation of a
surgical region.
[0061] Tether 130 is delivered along the surgical pathway to a
surgical site adjacent vertebrae V. Tether 130 is disposed with
vertebrae V. In one embodiment, as shown in FIGS. 13-16, a loop 136
of tether 130 is disposed about a transverse process of a vertebra
V2 by passing end 132 continuously about the transverse process.
This configuration fixes and/or attaches end 132 with the
transverse process and/or lamina.
[0062] Upon disposal of end 132 with vertebra V2, tether 130 is
disposed with connector 140. Tether 130 is threaded through cavity
150, passageway 162 and passageway 146. Spinal rod 170 is disposed
with passageway 162 and reduced with connector 140 to vertebrae V.
Set screw 156 is engaged with opening 154 to fix and/or
provisionally fix spinal rod 170 with connector 140 and tether
130.
[0063] Arms 52, 54 of tensioner 12 are disposed adjacent connector
140. Lock 100 is rotated from a dosed orientation, as described
herein, in the direction shown by arrow A in FIG. 10, such that
lock 100 translates along the engagement portion of arm 54 to
engage barbs 88. Rotation of lock 100 causes arm 52 to rotate
and/or pivot about hinge 68, in the direction shown by arrow B in
FIG. 10, relative to arm 54 to dispose tensioner 12 in an open
orientation, as described herein.
[0064] Mating tabs 72, 94 are aligned with the mating slots of
connector 140. Lock 100 is rotated, in the direction shown by arrow
C in FIG. 10, such that lock 100 translates from barbs 88 along the
engagement portion of arm 54 to engage notch 86. Tabs 72, 94 rotate
into engagement with the slots of connector 140 for releasable
fixation and/or provisional fixation of tensioner 12 with connector
140, as shown in FIGS. 1, 13-16. Tensioner 12 is disposed in a
dosed orientation with connector 140.
[0065] End 134 of tether 130 extends from passageway 146. End 134
is drawn towards projection 30 and folded and/or rotated about the
surface of projection 30 such that tether 130 is wound and/or
wrapped around projection 30, as shown in FIGS. 12 and 13-16. A
portion of end 134 is disposed with slot 34 to engage the surface
defining slot 34 such that tether 130 is attached with and/or
provisionally locked with tensioner 12. This configuration
facilitates fixation of tether 130 with projection 30 during
tensioning, which includes increasing and decreasing tension in
tether 130.
[0066] Extensions 38a, 38b prevent and/or limit lateral movement of
tether 130 to resist and/or prevent tether 130 from disengaging
and/or slipping from the surface of projection 30. In some
embodiments, the tension and/or tensile force applied to tether 130
and/or corrective forces applied to vertebrae V can be increased by
rotating knob 44, in a clockwise direction shown by arrow E in FIG.
12. As such, the threaded engagement of carriage 18 with shaft 96,
as described herein, causes axial translation of carriage 18 along
axis X1 and relative to shaft 96, in the direction shown by arrow F
in FIG. 12. Carriage 18 is translated relative to arms 52, 54 and
the spinal construct, which includes connector 140 and spinal rod
170. Carriage 18 draws tether 130 to apply a tensioning force to
tether 130. This configuration tensions tether 130 about vertebra
V2 and tensions the spinal construct for attachment with vertebrae
V and/or to apply corrective treatment to vertebrae V.
[0067] In some embodiments, the tension and/or tensile force
applied to tether 130 and/or corrective forces applied to vertebrae
V can be decreased by rotating knob 44, in a counter clockwise
direction shown by arrow G in FIG. 12, to release tension. Carriage
18 threadably engages shaft 96 such that carriage 18 axially
translates along axis X1 and relative to shaft 96, in the direction
shown by arrow H in FIG. 12. Carriage 18 is translated relative to
arms 52, 54 toward the spinal construct. This configuration
releases tension in tether 130 and/or to adjust corrective
treatment to vertebrae V.
[0068] In some embodiments, lock 100 is rotated from the dosed
orientation and locking of arms 52, 54 with connector 140 to the
open orientation, as described herein. Rotation of lock 100 causes
arms 52, 54 to relatively rotate and/or pivot about hinge 68 and
release tabs 72, 94 from the slots of connector 140. Connector 140
is released from tensioner 12.
[0069] In some embodiments, spinal correction system 10 includes a
second spinal rod (not shown) delivered along the surgical pathway
to the surgical site adjacent a contra-lateral side of vertebrae V.
The second spinal rod is connected with the contra-lateral side of
vertebrae V via one or more tethers 130, similar to spinal rod 170
described herein. Spinal rod 170 and the second spinal rod are
fixed with vertebrae V in a side by side orientation and/or
bi-lateral arrangement to stabilize vertebrae V and affect growth
for a correction treatment to treat spine pathologies, as described
herein.
[0070] Upon completion of the procedure, the surgical instruments,
assemblies and non-implanted components of spinal correction system
10 are removed from the surgical site and the incision is closed.
One or more of the components of spinal correction system 10 can be
made of radiolucent materials such as polymers. Radiomarkers may be
included for identification under x-ray, fluoroscopy, CT or other
imaging techniques. In some embodiments, the use of surgical
navigation, microsurgical and image guided technologies may be
employed to access, view and repair spinal deterioration or damage,
with the aid of spinal correction system 10.
[0071] In some embodiments, spinal correction system 10 includes an
agent, which may be disposed, packed, coated or layered within, on
or about the components and/or surfaces of spinal correction system
10. In some embodiments, the agent may indude bone growth promoting
material, such as, for example, bone graft to enhance fixation of
the bone fasteners with vertebrae. In some embodiments, the agent
may indude one or a plurality of therapeutic agents and/or
pharmacological agents for release, including sustained release, to
treat, for example, pain, inflammation and degeneration.
[0072] In some embodiments, the components of spinal correction
system 10 may be employed to treat progressive idiopathic scoliosis
with or without sagittal deformity in either infantile or juvenile
patients, including but not limited to prepubescent children,
adolescents from 10-12 years old with continued growth potential,
and/or older children whose growth spurt is late or who otherwise
retain growth potential. In some embodiments, the components of
spinal correction system 10 may be used to prevent or minimize
curve progression in individuals of various ages.
[0073] 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.
* * * * *