U.S. patent application number 17/078648 was filed with the patent office on 2022-04-28 for surgical instrument and method.
The applicant listed for this patent is Warsaw Othopedic, Inc.. Invention is credited to Brian A. Butler, William Alan Rezach.
Application Number | 20220125488 17/078648 |
Document ID | / |
Family ID | 1000005220860 |
Filed Date | 2022-04-28 |
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United States Patent
Application |
20220125488 |
Kind Code |
A1 |
Rezach; William Alan ; et
al. |
April 28, 2022 |
SURGICAL INSTRUMENT AND METHOD
Abstract
A surgical instrument includes a first member being engageable
to an inner surface of a spinal implant. An actuator is connected
to a second member such that the second member is translatable
relative to the first member for connecting the spinal implant to a
bone fixation device. Systems, spinal constructs, implants and
methods are disclosed.
Inventors: |
Rezach; William Alan;
(Covington, TN) ; Butler; Brian A.; (Millington,
TN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Warsaw Othopedic, Inc. |
Warsaw |
IN |
US |
|
|
Family ID: |
1000005220860 |
Appl. No.: |
17/078648 |
Filed: |
October 23, 2020 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/7082 20130101;
A61B 17/00234 20130101 |
International
Class: |
A61B 17/70 20060101
A61B017/70; A61B 17/00 20060101 A61B017/00 |
Claims
1. A surgical instrument comprising: an outer sleeve having a
distal portion, the distal portion including at least one
expandable projection being engageable to an inner groove of a
spinal rod receiver of a bone fastener; an inner shaft having a
distal portion; and an actuator connected to the outer sleeve and
the inner shaft such that the distal portion of the inner shaft is
engageable to the distal portion of the outer sleeve to expand the
at least one projection into the inner groove to capture the spinal
rod receiver.
2. (canceled)
3. A surgical instrument as recited in claim 1, wherein the outer
sleeve includes at least one spring tab having the at least one
projection, the at least one spring tab biased radially inward and
expandable to engage the inner groove and capture the spinal rod
receiver.
4. A surgical instrument as recited in claim 1, wherein the distal
portion of the inner shaft expands the distal portion of the outer
sleeve to engage the inner groove and capture of the spinal rod
receiver to snap fit the spinal rod receiver to a bone fixation
device.
5. A surgical instrument as recited in claim 1, wherein the spinal
rod receiver includes a crown and the distal portion of the inner
shaft engages the crown for snap fit assembly to a bone fixation
device.
6. (canceled)
7. A surgical instrument as recited in claim 1, wherein the at
least one projection of the outer sleeve is biased radially
inward.
8. (canceled)
9. A surgical instrument as recited in claim 1, wherein the outer
sleeve includes opposing spring tabs including the projections, the
spring tabs bias radially inward and expand to engage the inner
surface and capture the receiver.
10. (canceled)
11. A surgical instrument as recited in claim 1, wherein the
actuator includes a pair of lever handles being rotatable relative
to the outer sleeve.
12. A surgical instrument as recited in claim 1, wherein the
actuator includes a handle being rotatable relative to the outer
sleeve and disposable in at least one non-locked orientation such
that the handle is movable relative to the outer sleeve and a
locked orientation such that the handle is fixed relative to the
outer sleeve.
13. (canceled)
14. A surgical instrument comprising: an outer sleeve including a
distal portion having at least one projection biased radially
inward; an inner shaft including a distal portion; and a handle
connected to the outer sleeve and the inner shaft such that the
distal portion of the inner shaft is engageable to the distal
portion of the outer sleeve to expand the at least one projection
into an inner groove of a spinal rod receiver of a bone fastener to
capture the spinal rod receiver.
15. A surgical instrument as recited in claim 14, wherein the
distal portion of the inner shaft expands the distal portion of the
outer sleeve to engage the inner groove capture the spinal rod
receiver to snap fit the spinal rod receiver to a bone fixation
device.
16. A surgical instrument as recited in claim 14, wherein the
distal portion of the outer sleeve includes opposing spring tabs,
including the projections.
17. (canceled)
18. A surgical instrument as recited in claim 14, wherein the
handle is rotatable relative to the outer sleeve and disposable in
at least one non-locked orientation such that the handle is movable
relative to the outer sleeve and a locked orientation such that the
handle is fixed relative to the outer sleeve.
19. A surgical instrument as recited in claim 14, wherein the
handle includes a pair of lever handles.
20. A surgical system comprising: a bone fastener shaft configured
for fixation to vertebral tissue; a spinal rod receiver including
an inner groove; and a surgical instrument including an outer
sleeve having a distal portion, the distal portion including at
least one expandable projection being engageable to the inner
groove and an inner shaft having a distal portion, the surgical
instrument further including an actuator connected to the outer
sleeve and the inner shaft such that the distal portion of the
inner shaft is engageable to the distal portion of the outer sleeve
to expand the at least one projection into the inner groove to
capture the spinal rod receiver.
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 and a method for treating a
spine.
BACKGROUND
[0002] Spinal disorders such as degenerative disc disease, disc
herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis,
kyphosis and other curvature abnormalities, 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 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. As part of
these surgical treatments, spinal constructs, which include
implants such as bone fasteners, connectors, plates and vertebral
rods are often used to provide stability to a treated region. These
implants can redirect stresses away from a damaged or defective
region while healing takes place to restore proper alignment and
generally support the vertebral members. Surgical instruments are
employed, for example, to engage the fasteners for attachment of
implants to the exterior of two or more vertebral members. This
disclosure describes an improvement over these prior
technologies.
SUMMARY
[0004] In one embodiment, a surgical instrument is provided. The
surgical instrument includes a first member being engageable to an
inner surface of a spinal implant. An actuator is connected to a
second member such that the second member is translatable relative
to the first member for connecting the spinal implant to a bone
fixation device. In some embodiments, systems, spinal constructs,
implants and methods are disclosed.
[0005] In one embodiment, the surgical instrument includes an outer
sleeve including a distal portion having at least one spring tab
biased radially inward and expandable for engagement to an inner
surface of a spinal implant. An inner shaft includes a distal
portion and a handle is connected to the inner shaft such that the
distal portion of the inner shaft is translatable relative to the
distal portion of the outer sleeve for connecting the spinal
implant to a bone fastener shaft.
[0006] In one embodiment, a surgical system is provided. The
surgical system includes a bone fastener shaft configured for
fixation to vertebral tissue. A spinal implant receiver is
configured for connection to the bone fastener shaft. A surgical
instrument includes a first member that is engageable to an inner
surface of the spinal implant receiver and a second member. The
surgical instrument further includes an actuator connected to the
second member such that the second member is translatable relative
to the first member for connecting the spinal implant receiver to
the bone fastener shaft.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] The present disclosure will become more readily apparent
from the specific description accompanied by the following
drawings, in which:
[0008] FIG. 1 is a perspective view of components of one embodiment
of a surgical system in accordance with the principles of the
present disclosure;
[0009] FIG. 2 is a side cross section view of the components shown
in FIG. 1;
[0010] FIG. 3 is a break away view of components of one embodiment
of a surgical system in accordance with the principles of the
present disclosure;
[0011] FIG. 4 is a break away cross section view of components of
one embodiment of a surgical system in accordance with the
principles of the present disclosure;
[0012] FIG. 5 is a perspective view of the components shown in FIG.
1;
[0013] FIG. 6 is a side cross section view of the components shown
in FIG. 1;
[0014] FIG. 7 is a break away view of components of one embodiment
of a surgical system in accordance with the principles of the
present disclosure;
[0015] FIG. 8 is a cross section view of the components shown in
FIG. 7;
[0016] FIG. 9 is a side cross section view of the components shown
in FIG. 1;
[0017] FIG. 10 is a perspective view of the components shown in
FIG. 1;
[0018] FIG. 11 is a cross section view of the components shown in
FIG. 10;
[0019] FIG. 12 is a break away view of components of one embodiment
of a surgical system in accordance with the principles of the
present disclosure;
[0020] FIG. 13 is a cross section view of the components shown in
FIG. 12;
[0021] FIG. 14 is a perspective view of components of one
embodiment of a surgical system in accordance with the principles
of the present disclosure;
[0022] FIG. 15 is a perspective view of components of one
embodiment of a surgical system in accordance with the principles
of the present disclosure;
[0023] FIG. 16 is a perspective view of the components shown in
FIG. 15;
[0024] FIG. 17 is a break away view of components of one embodiment
of a surgical system in accordance with the principles of the
present disclosure;
[0025] FIG. 18 is a cross section view of the components shown in
FIG. 17;
[0026] FIG. 19 is an enlarged break away view of the components
shown in FIG. 15;
[0027] FIG. 20 is a cross section view of the components shown in
FIG. 17;
[0028] FIG. 21 is a cross section view of the components shown in
FIG. 17; and
[0029] FIG. 22 is a cross section view of the components shown in
FIG. 17.
DETAILED DESCRIPTION
[0030] The exemplary embodiments of a surgical system are discussed
in terms of medical devices for the treatment of musculoskeletal
disorders and more particularly, in terms of a surgical system and
a method for treating a spine. In some embodiments, the present
surgical system includes a surgical instrument, for example, an
inserter engageable to a spinal implant, for example, a receiver.
In some embodiments, the present surgical system includes an
inserter having an end engageable to an inner surface of a spinal
implant to capture and connect the spinal implant to a bone
fixation device, including a bone fastener shaft.
[0031] In some embodiments, the present surgical system includes a
surgical instrument, for example, an inserter configured to connect
a spinal implant to a bone fixation device, including a bone
fastener shaft. In some embodiments, the inserter includes an outer
sleeve, an inner shaft and an actuator. In some embodiments, the
actuator is connected to the inner shaft such that the inner shaft
is translatable relative to the outer sleeve for connecting the
spinal implant to the bone fastener shaft. In some embodiments, the
inserter is configured to connect a spinal implant to bone fixation
devices, including bone screws, hooks and/or plates.
[0032] In some embodiments, the present surgical system includes a
surgical instrument, for example, an inserter configured for
utilization with a modular screw platform. In some embodiments, the
modular screw platform includes a plurality of spinal implants, for
example, a plurality of receivers having a plurality of heights
and/or a plurality of external geometries. In some embodiments, an
end of the inserter is configured to engage to the plurality of
receivers. In some embodiments, the end of the inserter engages
rocker holes of the receiver via an inner surface of the receiver
to secure the receiver to the end of the inserter.
[0033] In some embodiments, the present surgical system includes a
surgical instrument, for example, an inserter having an outer
sleeve and an inner shaft with a low profile configuration. In some
embodiments, the low profile configuration includes an end of the
inserter configured to fit within a profile of a spinal implant,
for example, a receiver to secure the receiver to the end of the
inserter. In some embodiments, a profile of the spinal implant
includes an interior surface that defines an internal groove. In
some embodiments, the internal groove is disposed proximal to a
receiver crown. In some embodiments, the outer sleeve engages the
internal groove to secure the inserter to the receiver.
[0034] In some embodiments, the present surgical system includes a
surgical inserter configured for securement to a spinal implant
receiver. In some embodiments, the inserter includes an outer
sleeve, an inner shaft and an actuator. In some embodiments, the
outer sleeve includes an end including spring tabs that are biased
radially inward and are expandable to engage to an inner surface of
the receiver. In some embodiments, to secure the inserter to the
receiver, the receiver is loaded to the distal end of the inserter.
In some embodiments, the spring tabs are bent inwardly to enable
the inserter to pass through the receiver. In some embodiments, the
spring tabs are bent inwardly to enable the inserter to pass
through a minor diameter of a thread of the inner surface of the
receiver. In some embodiments, the spring tabs are heat treated in
a bent position to bias the spring tabs inwardly into a closed
position. In some embodiments, the receiver is secured to the
inserter. In some embodiments, the inner shaft is translated toward
the distal end of the inserter to deploy the spring tabs in an
outward direction. In some embodiments, deployment of the spring
tabs in the outward direction engages the spring tabs to the inner
surface of the receiver to secure the receiver to the inserter. In
some embodiments, the receiver is locked to the inserter. In some
embodiments, the inner shaft is translatable through the spring
tabs to push a crown of the spinal implant in a downward direction
to engage a head of a screw shaft.
[0035] In some embodiments, the present surgical system includes a
surgical inserter configured for securement to a spinal implant
receiver. In some embodiments, the inserter includes a first member
and a second member. In some embodiments, the first member includes
an outer sleeve and the second member includes an inner shaft. In
some embodiments, the inserter includes an actuator, for example, a
pair of handles. In some embodiments, the actuator is connected to
the inner shaft such that the inner shaft is translatable relative
to the outer sleeve for securing the receiver to a bone fixation
device, including a bone fastener shaft. In some embodiments, the
inserter includes a latch, for example, a locking mechanism
including a finger engagement surface. In some embodiments, the
latch is connected to the actuator in at least one non-locked
orientation such that the actuator is movable relative to the inner
shaft and a locked orientation such that the actuator is fixed
relative to the inner shaft. In some embodiments, the actuator is
movable between positions such that the inserter can be secured and
unsecured to the inserter. In some embodiments, the actuator is
movable between an open position including the non-locked
orientation, an intermediate position including the locked
orientation and a closed position including the non-locked
orientation. In some embodiments, the actuator translates the inner
shaft relative to the outer sleeve via a threaded engagement.
[0036] In some embodiments, the actuator is oriented in the open
position. In some embodiments, in the open position, the receiver
is loaded into the distal end. In some embodiments, in the open
position, the receiver can be loaded and/or removed from the distal
end of the inserter. In some embodiments, in the open position,
spring tabs of the outer sleeve are in a flexed inward state such
that the spring tabs can be inserted into the interior features of
the receiver. In some embodiments, in the open position, the spring
tabs are in a collapsed inward state to slide through a minor
diameter of an interior of the receiver.
[0037] In some embodiments, the actuator is oriented in the
intermediate position. In some embodiments, in the intermediate
position, the actuator is locked until the latch is manually
depressed by a user. In some embodiments, the latch locks onto a
pin that is centrally disposed on a shaft of the member to prevent
the actuator from opening or closing. In some embodiments, in the
intermediate position, the receiver is secured to the end of the
inserter. In some embodiments, in the intermediate position, the
outer sleeve remains fixed and the inner shaft translates in a
direction, for example, axially. In some embodiments, the inner
shaft translates a distance of, for example 2.0 to 3.0 mm. In some
embodiments, the actuator is released to disconnect the receiver
from the distal end. In some embodiments, the spring tabs are
forced in an outward orientation by translation of the inner shaft
to engage to the interior features of the receiver.
[0038] In some embodiments, the actuator is oriented in the closed
position. In some embodiments, the latch is depressed and the
actuator is compressed to position the inserter in the locking
orientation to lock the receiver to the distal end. In some
embodiments, in the closed position, the actuator is released when
the actuator is compressed. In some embodiments, in the closed
position, the outer sleeve remains fixed and the inner shaft
translates in a direction, for example, axially. In some
embodiments, the inner shaft translates a distance of 6.0 mm. In
some embodiments, in the closed position, the receiver is secured
to the end of the inserter via the spring tabs that remain in the
outward orientation as the inner shaft translates axially beyond
the spring tabs. In some embodiments, a tip of the inner shaft
pushes an implant crown in a downward direction and into the
receiver.
[0039] In some embodiments, the present surgical system includes a
surgical inserter employed with a method for connecting a spinal
implant receiver to a bone fixation device, including a bone
fastener shaft. In some embodiments, the method includes the step
of introducing an inserter. In some embodiments, the inserter
includes a proximal end and a distal end. In some embodiments, the
inserter includes an outer sleeve, an inner shaft, a latch and an
actuator. In some embodiments, the method includes the step of
disposing the inserter in an initial open position to load an
implant, for example, a receiver to the distal end. In some
embodiments, in the open position, the receiver is loaded into the
distal end. In some embodiments, the method includes the step of
disposing the inserter in an intermediate position to secure the
receiver to the distal end. In some embodiments, in the
intermediate position, the actuator is locked until the latch is
manually depressed by a user. In some embodiments, the method
includes the step of disposing the inserter into a closed position
to lock the receiver to the distal end. In some embodiments, in the
closed position, the actuator is released when the actuator is
compressed.
[0040] In some embodiments, the system of the present disclosure
may be employed to treat spinal disorders, for example,
degenerative disc disease, disc herniation, osteoporosis,
spondylolisthesis, stenosis, scoliosis and other curvature
abnormalities, kyphosis, tumor and fractures. In some embodiments,
the system of 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 system 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, direct lateral,
postero-lateral, and/or antero-lateral approaches, and in other
body regions. The system of 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 of the present disclosure may also be used on animals,
bone models and other non-living substrates, for example, in
training, testing and demonstration.
[0041] The system of 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. 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 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, 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".
[0042] 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, for example, microdiscectomy
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 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.
[0043] The following discussion includes a description of a
surgical system including a surgical instrument, related components
and 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 the exemplary
embodiments of the present disclosure, which are illustrated in the
accompanying figures. Turning to FIGS. 1-13, there are illustrated
components of a surgical system 10.
[0044] The components of surgical 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 surgical system 10, individually or collectively, can be
fabricated from materials such as stainless steel alloys, aluminum,
commercially pure titanium, titanium alloys, Grade 5 titanium,
super-elastic titanium alloys, cobalt-chrome alloys, superelastic
metallic alloys (e.g., Nitinol, super elasto-plastic metals, such
as GUM METAL.RTM.), ceramics and composites thereof such as calcium
phosphate (e.g., SKELITE.TM.), 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, 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, 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.
[0045] The components of surgical 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 surgical system 10 may be
monolithically formed, integrally connected or include fastening
elements and/or instruments, as described herein.
[0046] Surgical system 10 can be employed, for example, with a
minimally invasive procedure, including percutaneous techniques,
mini-open and open surgical techniques to deliver and introduce
instrumentation and/or components of spinal constructs at a
surgical site within a body of a patient, for example, a section of
a spine. In some embodiments, one or more of the components of
surgical system 10 are configured for engagement with existing
spinal constructs, which may include spinal implants such as one or
more rods, fasteners, plates and connectors. In some embodiments,
the spinal constructs can be attached with vertebrae in a revision
surgery to manipulate tissue and/or correct a spinal disorder, as
described herein.
[0047] Surgical system 10 includes a surgical instrument, for
example inserter 12. Inserter 12 is configured for engagement to a
spinal implant, for example, a receiver 14 of a bone fastener 16,
as shown in FIG. 3. Inserter 12 is configured to secure receiver 14
to a bone fixation device, including shaft 18 of bone fastener 16
that has been implanted into a surgical site, for example,
vertebral tissue, as described herein. Inserter 12 is configured
for utilization with a modular screw platform such that inserter 12
can be implemented with various embodiments of receiver 14.
[0048] Inserter 12 includes a proximal end 20 and a distal end 22,
as shown in FIG. 1. Inserter 12 extends along and defines a
longitudinal axis X1, as shown in FIG. 2. In some embodiments,
inserter 12 may have various cross-section configurations, for
example, oval, oblong, triangular, rectangular, square, polygonal,
irregular, uniform, non-uniform, variable, tubular and/or
tapered.
[0049] Inserter 12 includes a member having an outer sleeve 26 and
a member having an inner shaft 30, as shown in FIGS. 3 and 4.
Sleeve 26 and shaft 30 are configured for engagement to receiver
14. Sleeve 26 is configured for engagement to an inner surface of
receiver 14, as described herein. Sleeve 26 includes an end 32 and
an end 34, as shown in FIG. 5. In some embodiments, sleeve 26 may
have various cross-section configurations, for example, oval,
oblong, triangular, rectangular, square, polygonal, irregular,
uniform, non-uniform, variable, tubular and/or tapered.
[0050] End 32 is configured for engagement to an actuator 36, as
shown in FIG. 1. An outer shaft 38 is disposed at end 32 and is
configured for engagement to actuator 36 and a latch 40, as shown
in FIG. 2 and described herein. Latch 40 is connected to actuator
36 such that actuator 36 is movable relative to sleeve 26. See
also, for example, the embodiments and disclosure of an inserter
and method for surgically treating a spine, shown and described in
commonly owned and assigned U.S. patent application Ser. No. ______
filed ______, 2020 (docket no. A0003739US01), and published as U.S.
Pat. No. ______, on ______, the entire contents of which being
incorporated herein by reference. In some embodiments, shaft 38 may
have various cross-section configurations, for example, oval,
oblong, triangular, rectangular, square, polygonal, irregular,
uniform, non-uniform, variable, tubular and/or tapered.
[0051] End 34 is configured for engagement to an inner surface of
receiver 14, as shown in FIGS. 3, 4, 7, 8, 12 and 13. End 34 is
expandable to engage the inner surface of receiver 14 to secure
receiver 14 to inserter 12. End 34 includes a spring tab 42 and a
spring tab 44. Tab 42 opposes tab 44. Tabs 42 and 44 are flexible,
biased radially inward and are expandable to engage the inner
surface of receiver 14 and to secure receiver 14 to inserter 12.
Tab 42 includes an outer surface that defines a projection 46 and
tab 44 includes an outer surface that defines a projection 48, as
shown in FIG. 4. The inner surface of receiver 14 defines a groove
50 configured for engagement to projections 46 and 48, as shown in
FIG. 4. In some embodiments, sleeve 26 includes one or more spring
tabs.
[0052] Shaft 30 includes an end 52 and an end 54, as shown in FIG.
2. Shaft 30 is in co-axial alignment relative to sleeve 26 and
extends along longitudinal axis X1, as shown in FIG. 2. Shaft 30
translates relative to sleeve 26 to secure receiver 14 to shaft 18,
as described herein. Shaft 30 is configured to expand sleeve 26
into engagement to the inner surface of receiver 14 to secure
receiver 14. In some embodiments, shaft 30 may have various
cross-section configurations, for example, oval, oblong,
triangular, rectangular, square, polygonal, irregular, uniform,
non-uniform, variable, tubular and/or tapered.
[0053] End 52 is configured for engagement to an end 56 of shaft
38, as shown in FIG. 6. End 52 includes a threaded portion 58 that
is configured for disposal into a threaded recess 60 of end 56, as
shown in FIG. 6. Shaft 30 is fixed to shaft 38 and shaft 30 is
movable relative to sleeve 26, as shown in FIGS. 6, 9 and 11. A
biasing member, for example, a spring 62 is configured for disposal
about end 56, as shown in FIG. 9 and is configured to provide
energy in an axial direction to facilitate movement of shaft 30
when actuator 36 is released, as described herein.
[0054] End 54 is configured for engagement to a crown 64 disposed
within a cavity 66, as shown in FIG. 4, of receiver 14, as shown in
FIGS. 3, 7 and 12. Crown 64 is configured for locking receiver 14
to shaft 18 in a snap fit assembly, as described herein. In some
embodiments, end 54 may have various cross-section configurations,
for example, oval, oblong, triangular, rectangular, square,
polygonal, irregular, uniform, non-uniform, variable, tubular
and/or tapered.
[0055] End 20 of inserter 12 includes actuator 36, as shown in FIG.
1. Actuator 36 is connected to shaft 30 such that shaft 30
translates relative to sleeve 26 for connecting receiver 14 to
shaft 18. Actuator 36 is rotatable relative to sleeve 26 and is
disposable between an open position including a non-locked
orientation such that actuator 36 is movable relative to sleeve 26
(FIGS. 1 and 2), an intermediate position including a locked
orientation such that actuator 36 is fixed relative to sleeve 26
(FIGS. 5 and 6) and a closed position including a non-locked
orientation such that actuator 36 is movable relative to sleeve 26
(FIGS. 10 and 11), as described herein. In a natural state,
actuator 36 is biased to the open position and is automatically
movable from the closed position to the open position.
[0056] Actuator 36 includes a pair of lever handles 68, 70, as
shown in FIG. 2 that are rotatable relative to sleeve 26. In some
embodiments, handles 68, 70 may have various cross-section
configurations, for example, oval, oblong, triangular, rectangular,
square, polygonal, irregular, uniform, non-uniform, variable,
tubular and/or tapered. In some embodiments, an outer surface of
handles 68, 70 has one or more of various surface configurations,
for example, rough, threaded, arcuate, undulating, porous,
semi-porous, dimpled, polished and/or textured. In some
embodiments, actuator 36 includes one or more handles.
[0057] Handle 68 includes a bar linkage 72 that is rotatably
engaged to sleeve 26, as shown in FIG. 2. Linkage 72 includes an
end 74 and an end 76. End 74 includes a surface that defines an
opening 78. A surface of handle 68 defines an opening 80. End 74
engages handle 68 via a pin 82 that is disposed within openings 78
and 80. End 76 includes a surface that defines an opening 84. A
surface of sleeve 26 defines an opening 86. End 76 engages sleeve
26 via a pin 88 that is disposed within openings 84 and 86.
Engagement between end 74 of linkage 72 and handle 68 creates a
pivot point P1, as shown in FIG. 6. Engagement between end 76 of
linkage 72 and sleeve 26 creates a pivot point P2, as shown in FIG.
6.
[0058] Handle 70 includes a bar linkage 90 rotatably engaged to
sleeve 26, as shown in FIG. 2. Linkage 90 includes an end 92 and an
end 94. End 92 includes a surface that defines an opening 96. A
surface of handle 70 defines an opening 98. End 92 engages handle
70 via a pin 100 that is disposed within openings 96 and 98. End 94
includes a surface that defines an opening 102. A surface of sleeve
26 defines an opening 104. End 94 engages sleeve 26 via a pin 106
that is disposed within openings 102 and 104. Engagement between
end 92 of linkage 90 and handle 70 creates a pivot point P3, as
shown in FIG. 6. Engagement between end 94 of linkage 90 and sleeve
26 creates a pivot point P4, as shown in FIG. 6.
[0059] Latch 40 is connected to actuator 36 in a non-locked
orientation (FIGS. 1-2 and 10-11) such that actuator 36 is movable
relative to sleeve 26 in the open position and the closed position,
and a locked orientation (FIGS. 5 and 6) such that actuator 36 is
fixed relative to sleeve 26 in the intermediate position. Latch 40
is connected to actuator 36 via handle 68, as shown in FIG. 2. A
surface of handle 68 defines an opening 108 and a surface of latch
40 defines an opening 110, as shown in FIG. 9. A pin 112 is
configured for disposal within openings 108 and 110 to rotatably
engage latch 40 with handle 68. Engagement between handle 68 and
latch 40 creates a pivot point P5, as shown in FIG. 6. A biasing
member, for example, a torsion spring 114 is configured for
disposal with pin 112 and engagement to latch 40, as shown in FIG.
9. Spring 114 is configured to provide torque to latch 40 when
pivoted into a non-locked and/or a locked orientation. An end 116
of spring 114 is configured for engagement to an indent 118 of
latch 40 and an end 120 of spring 114 is configured for engagement
to a pin 122, as shown in FIG. 9.
[0060] Latch 40 includes an outer surface that defines a trigger
124 including a finger engagement surface, as shown in FIG. 2.
Trigger 124 is configured for engagement with a user such that
latch 40 can be manually depressed to rotatably translate latch 40
into a selected orientation, as described herein. In some
embodiments, the finger engagement surface can have one or more
various surface configurations, for example, rough, threaded,
arcuate, undulating, porous, semi-porous, dimpled, polished and/or
textured.
[0061] Latch 40 includes a surface that defines a slot 126
configured for engagement to a pin 128 disposed in a cavity 130 of
shaft 38. Latch 40 is rotatable relative to actuator 36 for capture
of shaft 30 in the intermediate position such that pin 128 is
disposed in slot 126 in a locked orientation, as shown in FIG. 6
and described herein. In some embodiments, slot 126 includes a
C-groove configuration. In some embodiments, slot 126 may have
various cross-section configurations, for example, oval, oblong,
triangular, rectangular, square, polygonal, irregular, uniform,
non-uniform, variable, tubular and/or tapered. In some embodiments,
slot 126 has one or more of various surface configurations, for
example, rough, threaded, arcuate, undulating, porous, semi-porous,
dimpled, polished and/or textured.
[0062] Shaft 38 includes a surface that defines an opening 132, as
shown in FIG. 1 that is configured for movable disposal of latch 40
such that latch 40 can translate through shaft 38 to engage pin
128. In some embodiments, opening 132 may have various
cross-section configurations, for example, oval, oblong,
triangular, rectangular, square, polygonal, irregular, uniform,
non-uniform, variable, tubular and/or tapered.
[0063] Latch 40 defines a ramp 134 and a ramp 136 disposed at a
selected angular orientation a relative to ramp 134, as shown in
FIGS. 2, 6, 9 and 11. Ramps 134, 136 are configured for slidable
engagement with pin 128 to facilitate movement of actuator 36
relative to shaft 30 between the positions, as described herein.
Slidable engagement between ramps 134, 136 and pin 128 is actuated
via spring 114. In some embodiments, ramps 134, 136 enable actuator
36 to fully return to the open position from the closed position
without actuator 36 becoming disposed in the intermediate position.
Spring 62 provides the energy to return actuator 36 to the open
position. In some embodiments, ramps 134, 136 are configured to
enable inserter 12 to automatically return to the open position
from the closed position. In some embodiments, ramps 134, 136 are
configured to prevent inserter 12 from capture in the intermediate
position via engagement between pin 128 and slot 126, as described
herein. Ramps 134, 136 are relatively oriented to form angle
.alpha., as shown in FIG. 11. In some embodiments, angle .alpha. is
in a range from greater than 0 to 90 degrees.
[0064] In the open position, as shown by arrows J in FIG. 1, latch
40 is oriented with actuator 36 in the non-locked orientation where
pin 128 engages an end surface 138 of latch 40, as shown in FIG. 2.
In the intermediate position, as shown by arrows C in FIG. 5,
actuator 36 is manually compressed and slot 126 translates relative
to pin 128 such that a surface of slot 126 engages pin 128 to
orient latch 40 into the locked orientation, as shown in FIG. 6.
Latch 40 is depressed, as shown by arrow F in FIG. 9, and spring
114 is biased and pin 128 engages ramp 136, as shown in FIG. 9. In
the closed position, as shown by arrows G in FIG. 10, actuator 36
is manually compressed and pin 128 translates from ramp 136 to ramp
134 such that latch 40 is oriented into the non-locked orientation,
as shown in FIG. 11.
[0065] Ramps 134, 136 enable inserter 12 to automatically return to
an open position from the closed position and prevents inserter 12
from capture in the intermediate position. When actuator 36 is
further compressed and released, inserter 12 automatically returns
to the open position from the closed position. In some embodiments,
actuator 36 is further compressed from the closed position and
rapidly released to automatically return to the open position. In
some embodiments, actuator 36 is further compressed from the closed
position and slowly released such that actuator 36 returns to the
intermediate position and latch 40 is depressible to return
actuator 36 to the open position.
[0066] Latch 40 includes a slot 138, as shown in FIG. 6. Slot 138
includes an end, for example, a rotatable limit 140 and an end, for
example a rotatable limit 142. Limits 140, 142 are configured to
limit the rotation of latch 40 relative to actuator 36. Handle 68
includes an opening 144, as shown in FIG. 5. A pin 146 is
configured for disposal within slot 138 and opening 144 such that
when latch 40 rotates, pin 146 abuts limits 140, 142. When actuator
36 is in the open position and latch 40 is in the non-locked
orientation, pin 146 abuts with limit 142. In the intermediate
position, latch 40 is disposed in the locked orientation such that
pin 146 abuts limit 142. In the non-locked orientation, latch 40 is
depressed via trigger 124 and pin 146 is disposed within an
intermediate section 148, as shown in FIG. 9. In the closed
position, latch 40 is disposed in the non-locked orientation, and
pin 146 abuts limit 140, as shown in FIG. 11.
[0067] In operation, handles 68, 70 are movable to the open
position, as shown by arrows J in FIG. 1, and latch 40 is disposed
with actuator 36 in the non-locked orientation, as shown in FIG. 2.
Receiver 14 is loaded into end 22 of inserter 12. In the open
position, tabs 42, 44 are in a biased radially inward direction, as
shown by arrows B in FIG. 4, and tabs 42, 44 do not engage groove
50 of receiver 14.
[0068] Handles 68, 70 of actuator 36 are movable to the
intermediate position, as shown by arrows C in FIG. 5, and latch 40
is disposed in the locked orientation, as shown in FIG. 6. Latch 40
locks with pin 128 via slot 126 to prevent handles 68, 70 from
opening or closing. In the intermediate position, receiver 14 is
secured to end 22 of inserter 12, as shown in FIG. 7. Shaft 30
translates in a direction, for example, axially, as shown by arrow
E in FIG. 7 and engages an inner surface of tabs 42, 44 of sleeve
26 to expand tabs 42, 44 to engage groove 50 of receiver 14.
[0069] Trigger 124 is depressed, as shown by arrow F in FIG. 9 and
handles 68, 70 are compressed, for example, in an inward direction
as shown by arrows G in FIG. 10, such that shaft 30 translates
axially, as shown by arrow H in FIG. 12 and sleeve 26 remains
engaged to groove 50. Handles 68, 70 are movable to the closed
position, as shown by arrows G in FIG. 10, and latch 40 is
disposable in the non-locked orientation, as shown in FIG. 11. End
54 of shaft 30 drives crown 64 axially, as shown by arrow I in FIG.
13. Handles 68, 70 are further compressed from the closed position
and rapidly released to automatically return to the open position,
and receiver 14 is released from end 22.
[0070] In assembly, operation and use, surgical system 10, is
employed with a surgical procedure, for example, a surgical
treatment of an applicable condition or injury of an affected
section of a spinal column and adjacent areas within a body. In
some embodiments, surgical system 10 can be used in any surgical
method or technique including open surgery, mini-open surgery,
minimally invasive surgery and percutaneous surgical implantation,
whereby vertebrae V is accessed, such as through a mini-incision,
and possibly also via a sleeve (not shown) that provides a
protected passageway to vertebrae V. Once access to the surgical
site is obtained, the particular surgical procedure can be
performed for treating the spine disorder.
[0071] An incision is made in the body of a patient and a cutting
instrument (not shown) creates a surgical pathway. A preparation
instrument (not shown) can be employed to prepare tissue surfaces
of or surrounding vertebrae V, as well as for aspiration and
irrigation of a surgical region. Pilot hole(s) (not shown) are made
with the selected areas of bone, for example vertebrae for
receiving shaft 18.
[0072] Handles 68, 70, as described herein, are movable to the open
position, as shown by arrows J in FIG. 1, and latch 40 is disposed
with actuator 36 in the non-locked orientation, as shown in FIG. 2.
Receiver 14 is loaded to end 22 of inserter 12, as described
herein, in a direction shown by arrow A in FIG. 3. Handles 68, 70
of actuator 36 are movable to the intermediate position, as shown
by arrows C in FIG. 5, and latch 40 is disposed in the locked
orientation, as shown in FIG. 6. In the intermediate position,
receiver 14 is secured to end 22 of inserter 12, as shown in FIG.
7. Shaft 30 translates axially, as shown by arrow E in FIG. 7 and
engages an inner surface of tabs 42, 44 of sleeve 26 to expand tabs
42, 44 to engage groove 50 of receiver 14.
[0073] Handles 68, 70 are movable to the closed position, as shown
by arrows G in FIG. 10, and latch 40 is disposable in the
non-locked orientation, as shown in FIG. 11. Trigger 124 is
depressed, as shown by arrow F in FIG. 9 and handles 68, 70 are
compressed in an inward direction as shown by arrows G in FIG. 10,
such that shaft 30 translates axially, as shown by arrow H in FIG.
12 and sleeve 26 remains engaged to groove 50. In the closed
position, end 54 of shaft 30 drives crown 64 axially, as shown by
arrow I in FIG. 13. Handles 68, 70 are further compressed from the
closed position and rapidly released to automatically return to the
open position, and receiver 14 is released from end 22.
[0074] Upon completion of a procedure, inserter 12, surgical
instruments and/or tools, assemblies and non-implanted components
of surgical system 10 are removed and the incision(s) are closed.
One or more of the components of surgical 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 surgical system 10.
[0075] In some embodiments, surgical system 10 may include one or a
plurality of bone fixation devices, including plates, connectors,
spinal rods and/or bone fasteners for use with a single vertebral
level or a plurality of vertebral levels. In some embodiments, one
or more of bone fixation devices may be engaged with tissue in
various orientations, for example, series, parallel, offset,
staggered and/or alternate vertebral levels. In some embodiments,
one or more bone fixation devices may comprise multi-axial screws,
sagittal angulation screws, pedicle screws, mono-axial screws,
uni-planar screws, facet screws, fixed screws, tissue penetrating
screws, conventional screws, expanding screws, wedges, anchors,
buttons, clips, snaps, friction fittings, compressive fittings,
expanding rivets, staples, nails, adhesives, posts, fixation plates
and/or posts.
[0076] In some embodiments, surgical system 10 includes an agent,
which may be disposed, packed, coated or layered within, on or
about the components and/or surfaces of surgical system 10. In some
embodiments, the agent may include bone growth promoting material,
for example, bone graft to enhance fixation of the fixation
elements with vertebrae. In some embodiments, the agent may be HA
coating. In some embodiments, the agent may include one or a
plurality of therapeutic agents and/or pharmacological agents for
release, including sustained release, to treat, for example, pain,
inflammation and degeneration.
[0077] In some embodiments, as shown in FIG. 14, surgical system 10
includes an implant support, for example, an extender 160 that
includes a spinal rod reducer 162. Extender 160 and reducer 162 are
configured for use with inserter 12. In some embodiments, extender
160 is oriented for manipulation, alignment and/or capture of
receiver 14 and reducer 162 is configured to dispose a spinal rod
(not shown) with receiver 14. Reducer 162 includes an inner surface
that defines a passageway 163 that is configured for disposal of
sleeve 26 of inserter 12. An outer surface 164 is threaded to an
inner surface of extender 160 that defines a passageway 166.
Reducer 162 is rotated to translate reducer 162 axially, in a
proximal or distal direction relative to inserter 12 and/or
extender 160. Reducer 162 is translated such that an end surface
168 engages the spinal rod in a configuration to move the spinal
rod relative to receiver 14 to drive and/or reduce the spinal rod
into receiver 14.
[0078] In some embodiments, as shown in FIGS. 15-22, surgical
system 10, includes an inserter 212, similar to inserter 12
described herein, configured for use with receiver 14, as shown in
FIG. 17. Inserter 212 includes a proximal end 220 and a distal end
222, as shown in FIG. 15. Inserter 212 extends along and defines a
longitudinal axis X2, as shown in FIG. 16.
[0079] Inserter 212 includes an outer sleeve 226 and an inner shaft
230, as shown in FIG. 18. Sleeve 226 and shaft 230 are configured
for engagement to receiver 14. Sleeve 226 includes an end 232 and
an end 234. In some embodiments, sleeve 226 may have various
cross-section configurations, for example, oval, oblong,
triangular, rectangular, square, polygonal, irregular, uniform,
non-uniform, variable, tubular and/or tapered.
[0080] End 232 is configured for engagement to an actuator 236,
similar to actuator 36, as shown in FIG. 18. Actuator 236 is
movable relative to sleeve 226, as described herein. An outer shaft
238 is disposed at end 232 and is configured for engagement to
actuator 236 and a latch 240, similar to latch 40 described herein,
as shown in FIG. 16. In some embodiments, shaft 238 may have
various cross-section configurations, for example, oval, oblong,
triangular, rectangular, square, polygonal, irregular, uniform,
non-uniform, variable, tubular and/or tapered.
[0081] End 234 is configured for engagement to an inner surface of
receiver 14, as shown in FIG. 17. End 234 is expandable to engage
the inner surface of receiver 14 to secure receiver 14 to inserter
12, as shown in FIG. 17. End 234 includes a spring tab 242 and a
spring tab 244. Tab 242 opposes tab 244. Tabs 242 and 244 are
flexible, biased radially inward and are expandable to engage the
inner surface of receiver 14 and to secure receiver 14 to inserter
212. Tab 242 includes an outer surface that defines a projection
246 and tab 244 includes an outer surface that defines a projection
248, as shown in FIG. 18. Groove 50 of receiver 14 is configured
for engagement to projections 246 and 248, as shown in FIG. 18. In
some embodiments, sleeve 226 includes one or more spring tabs.
[0082] End 234 includes an inner surface that defines a groove 245
and a groove 247, as shown in FIG. 19. Grooves 245, 247 are
configured for engagement to an end 254 of shaft 230 to facilitate
engagement of crown 64, as described herein.
[0083] Shaft 230 includes an end 252 and end 254, as shown in FIGS.
16 and 18. Shaft 230 is in co-axial alignment relative to sleeve
226 and extends along longitudinal axis X2, as shown in FIG. 16.
Shaft 230 translates relative to sleeve 226 to secure receiver 14
to shaft 18, as described herein. Shaft 230 is configured to expand
sleeve 226 into engagement to the inner surface of receiver 14 to
secure receiver 14. In some embodiments, shaft 230 may have various
cross-section configurations, for example, oval, oblong,
triangular, rectangular, square, polygonal, irregular, uniform,
non-uniform, variable, tubular and/or tapered.
[0084] End 252 is configured for engagement to an end 256 of shaft
238, as shown in FIG. 16, similar to end 52 engagement to end 56 of
shaft 38, as described above with regard to inserter 12. Shaft 230
is fixed to shaft 238 and shaft 230 is movable relative to sleeve
226. A biasing member, for example, a spring 262 is configured for
disposal about end 256, as shown in FIG. 16 and is configured to
provide energy in an axial direction to facilitate return movement
of shaft 230 when actuator 236 is released, as described
herein.
[0085] End 254 is configured for engagement to crown 64 disposed
within cavity 66 of receiver 14, as shown in FIG. 18. Crown 64 is
configured for locking receiver 14 to shaft 18, as described
herein. In some embodiments, end 254 may have various cross-section
configurations, for example, oval, oblong, triangular, rectangular,
square, polygonal, irregular, uniform, non-uniform, variable,
tubular and/or tapered.
[0086] End 220 of inserter 212 includes actuator 236, as shown in
FIG. 15. Actuator 236 is rotatable relative to sleeve 26 and is
disposable between an open position including a non-locked
orientation, an intermediate position including a locked
orientation and a closed position including a non-locked
orientation, as described herein. Actuator 236 includes a pair of
lever handles 268, 270, as shown in FIG. 15 that are rotatable
relative to sleeve 226.
[0087] Latch 240 is connected to actuator 236 in a non-locked
orientation such that actuator 236 is movable relative to sleeve
226 in the open position and closed position, and a locked
orientation such that actuator 236 is fixed relative to sleeve in
the intermediate position. Latch 240 is connected to actuator 236
via handle 268, in the same manner as latch 40 is connected to
actuator 36, described above with regard to FIGS. 1-13.
[0088] In operation, handles 268, 270 are movable to the open
position, and latch 240 is disposed with actuator 236 in the
non-locked orientation. Receiver 14 is loaded into end 222 of
inserter 212. In the open position, tabs 242, 244 are in a biased
radially inward direction, as shown by arrows K in FIG. 18, and
tabs 242, 244 do not engage groove 50 of receiver 14.
[0089] Handles 268, 270 of actuator 236 are movable to the
intermediate position, and latch 240 is disposed in the locked
orientation. In the intermediate position, receiver 14 is secured
to end 222 of inserter 212, as shown in FIG. 21. Shaft 230
translates in a direction, for example, axially, as shown by arrow
M in FIG. 21 and end 254 engages grooves 245, 247 and inner
surfaces of tabs 242, 244 of sleeve 226 to expand tabs 242, 244 to
engage groove 50 of receiver 14.
[0090] Handles 268, 270 are movable to the closed position, and
latch 240 is disposable in the non-locked orientation. A trigger
264 of latch 240 is depressed and handles 268, 270 are compressed,
for example, in an inward direction, such that shaft 230 translates
axially, as shown by arrow N in FIG. 22 and sleeve 226 remains
engaged groove 50. End 254 of shaft 230 drives crown 64 axially, as
shown by arrow N in FIG. 22. Handles 268, 270 are further
compressed from the closed position and rapidly released to
automatically return to the open position, and receiver 14 is
released from end 222.
[0091] 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.
* * * * *