U.S. patent application number 12/462766 was filed with the patent office on 2010-01-21 for upload shank swivel head bone screw spinal implant.
Invention is credited to Roger P. Jackson.
Application Number | 20100016904 12/462766 |
Document ID | / |
Family ID | 40130019 |
Filed Date | 2010-01-21 |
United States Patent
Application |
20100016904 |
Kind Code |
A1 |
Jackson; Roger P. |
January 21, 2010 |
Upload shank swivel head bone screw spinal implant
Abstract
A polyaxial bone screw having a bone implantable shank, a head
and a retaining ring. The retaining ring includes an outer partial
hemispherical surface and an inner bore with radially extending
channels and partial capture recesses. The shank includes a bone
implantable body with an external helical wound thread and an
upwardly extending capture structure. The capture structure
includes at least one spline which extends radially outward and has
a wedged surface that faces radially outward therefrom. The capture
structure operably passes through a central bore of the retaining
ring while the spline passes through a suitably shaped channel so
that the spline becomes positioned above the head at which time the
shank is rotated appropriately and the shank is drawn back
downwardly so that the spline engages and seats in the capture
recess. The head includes an internal cavity having a spherical
shaped surface that mates with the ring surface and has a lower
restrictive neck that prevents passage of the ring once the ring is
seated in the cavity.
Inventors: |
Jackson; Roger P.; (Prairie
Village, KS) |
Correspondence
Address: |
John C. McMahon
PO Box 30069
Kansas City
MO
64112
US
|
Family ID: |
40130019 |
Appl. No.: |
12/462766 |
Filed: |
August 7, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10818554 |
Apr 5, 2004 |
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12462766 |
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10464633 |
Jun 18, 2003 |
6716214 |
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10818554 |
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10651003 |
Aug 28, 2003 |
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10464633 |
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Current U.S.
Class: |
606/304 ;
606/305; 606/309 |
Current CPC
Class: |
A61B 17/7037 20130101;
A61B 17/7032 20130101 |
Class at
Publication: |
606/304 ;
606/305; 606/309 |
International
Class: |
A61B 17/86 20060101
A61B017/86 |
Claims
1. A polyaxial bone screw comprising: a) a head having a channel
adapted to receive an elongate longitudinal member and having a
lower restrictive neck; b) a shank having a lower portion adapted
to be implanted in a bone of a patient and an upper portion; said
shank upper portion being sized and shaped to be positioned in said
head so as to extend through said lower restrictive neck; c) a
retainer ring separate from said shank and received in said head;
said retainer ring mating with and non-pivotably coupled to said
shank upper portion to form a subassembly; said subassembly being
polyaxially rotatable relative to said head prior to locking of the
position of said shank relative to said head, said retainer ring
width being larger than a width of said head lower restrictive neck
so as to hold said shank upper portion in said head while allowing
polyaxial movement of said subassembly relative to said head during
positioning; and d) said shank upper portion being sized, shaped
and positioned so as to directly receive a downward force from said
longitudinal member after said longitudinal member is received in
said head channel, so as to lock the position of the shank relative
to the head.
2. The bone screw according to claim 1 wherein: a) the shank having
an upper end; and b) said retaining ring engages said shank upper
portion substantially below said shank upper end, such that between
the shank and the retainer ring only said shank receives said
direct downward force.
3. The bone screw according to claim 1 wherein: a) said shank is
cannulated.
4. The bone screw according to claim 1 wherein: a) said shank upper
portion includes an engagement end positioned and shaped so as to
be adapted to abut against a longitudinal member placed in said
channel.
5. The bone screw according to claim 4 wherein: a) said engagement
end is convex.
6. The bone screw according to claim 1 wherein: a) said shank upper
portion is sized and shaped to extend into said head channel when
the bone screw is fully assembled.
7. The bone screw according to claim 1 including: a) a closure
having mating structure for mating with said head and closing said
channel so as to be adapted to capture said rod in said
channel.
8. The bone screw according to claim 7 wherein: a) said closure
having a helically wound mating guide and advancement structure and
said head including a complimentary guide and advancement structure
sized and shaped to allow said closure to be rotated into and
torqued in said head.
9. The bone screw according to claim 8 in combination with: a) an
elongate member.
10. The bone screw according to claim 9 wherein: a) said shank
upper portion is shaped and positioned such that upon assembly of
said bone screw and said elongate member, said shank upper portion
has an engagement region that directly and frictionally engages
said elongate member so as to secure said shank in a selected fixed
angular configuration relative to said head.
11. In a polyaxial bone screw assembly having a shank and a head
with an upward opening receiving channel wherein the channel is
sized and shaped to receive a rod located above the shank during
use and having a lower restrictive neck; the improvement
comprising: a) said shank being sized and shaped to be loaded
upwardly through said head lower restrictive neck and thereafter
being captured in said head by a separate retainer ring secured to
said shank such that said shank and said retainer ring together
pivot relative to said head while said shank is in said head and
during positioning of the head relative to the shank, said shank
being sized, shaped and positioned in said head so as to receive a
downward force from above when a rod is placed in said channel so
as to lock the position of the shank and head relative to each
other.
12. The screw according to claim 11 wherein: a) said shank includes
an upper portion that extends into said channel when said shank is
loaded into said head.
13. The bone screw according to claim 12 wherein: a) said retainer
ring engages said shank substantially below said upper portion,
such that only said shank receives said direct downward force from
above.
14. The bone screw according to claim 12 wherein: a) said retainer
ring is sized and shaped to be uploaded into said head through said
lower restrictive neck.
15. The bone screw according to claim 12 wherein: a) said retainer
ring is sized and shaped to be downloaded into said head through
said channel.
16. The bone screw according to claim 15 wherein: a) said retainer
ring has a radiused surface adapted to pivotally mate with a
radiused mating surface in a chamber in said head.
17. In a polyaxial bone screw assembly having a shank and a head
with a channel sized and shaped to receive a rod; the improvement
comprising: a) said shank being sized and shaped to allow uploading
of said shank into said head such that said shank is positioned
directly beneath and receives a downward force from a rod located
in said channel; b) a retaining ring that is non-integral with said
head and said shank for capturing said shank in said head; said
ring being secured to said shank while in said head and pivoting
together with said shank during positioning of said shank relative
to said head, wherein said ring receives downward force from said
shank for frictionally securing said ring against said head in a
locked configuration.
18. In a polyaxial bone screw having a shank and a head wherein
said head includes a rod receiving channel; the improvement
comprising: a) said shank being sized and shaped to allow for said
shank to be uploaded into said head; b) said shank having an upper
engagement region sized and shaped to project sufficiently into
said channel after said shank is loaded into said head so as to
directly engage a rod received in said channel and to be biased
into locking engagement against said head due to application of
force to such a rod on a side of said rod opposite said shank; and
c) a retaining ring that is non-integral with the shank; the
retaining ring being joined with the shank in the head and
thereafter pivoting with said shank relative to said head.
19. The bone screw according to claim 18 wherein: a) said retaining
ring engages said shank substantially below said upper engagement
region, such that only said shank receives a direct force from
above.
20. The bone screw according to claim 18 in combination with a rod
and a closure operably closing said channel and biasing against
said rod opposite said shank and wherein said closure is rotatably
joinable to said head by flangeforms.
21. A polyaxial bone screw and rod assembly comprising: a) a head
having a channel adapted to receive a rod and having a lower bore;
b) a shank having a threaded lower portion adapted to be implanted
in a bone and an upper portion with a capture structure; c) said
shank upper portion being sized and shaped to be uploaded through
said head lower bore and thereafter extend into said channel so as
to engage a rod in said channel; d) a retaining structure having a
retainer ring that mates with and secures to said capture structure
to form a subassembly inside said head; said retainer ring being
non-integral with said shank; said retainer ring being downloaded
from a top of the said head; said subassembly polyaxially rotating
relative to said head during positioning of said shank relative to
said head; e) a rod that is sized and shaped to be received in said
channel; and f) said shank upper portion further including an upper
convex surface sized, shaped and positioned such that when said
bone screw is fully assembled and said rod is located in said
channel, said convex surface engages said rod to urge said
subassembly into a non-moveable configuration relative to said
head.
22. The bone screw according to claim 21 wherein: a) said retainer
ring engages said shank upper portion substantially below said
upper convex surface, such that only said shank receives a direct
downward force.
23. The bone screw according to claim 21 wherein: a) said retaining
ring is a continuous ring.
24. The bone screw according to claim 21 wherein: a) said retaining
ring is a discontinuous ring.
25. A polyaxial bone screw and rod assembly comprising: a) an
elongate rod; b) a head having a rod receiving channel for operably
receiving said rod; said channel being positioned between a pair of
upstanding and spaced arms with each arm having a first of a guide
and advancement structure thereon; said head having a lower bore
and a chamber located between said channel and said bore; c) a
shank having a lower portion adapted to be secured to a bone and an
upper capture portion sized and shaped to extend through said bore
and be polyaxially rotatably held within said head chamber during
positioning of said head relative to said shank; d) a non-integral
retainer sized and shaped to secure to said shank upper capture
portion of said shank so as to polyaxially rotate with said shank
relative to said head during positioning; e) said shank having an
integral upper rod engaging structure that is sized and shaped to
project into said channel and be engaged by said rod when said rod
is in said channel; and f) a closure for closing between said arms
and having second guide and advancement structure thereon that
rotatably mates with said first guide and advancement structure;
said closure upon advancement operably biasing said rod against
said shank so as to lock said shank in position relative to said
head.
26. The assembly according to claim 25 wherein: a) said first and
second guide and advancement structures are selected from a group
consisting of reverse angle threads, buttress threads and
flangeforms.
27. The assembly according to claim 25 wherein: a) said first and
second guide and advancement structures are flangeforms.
28. The assembly according to claim 25 wherein a) said shank is
cannulated along the entire length thereof.
29. The assembly according to claim 25 wherein: a) said retainer
having a first radiused surface such that said retainer rotates
with said shank during positioning of said shank relative to said
head; and b) said head chamber having a second radiused surface
operably receiving said first radiused surface and allowing
polyaxial rotation between said shank and said head during
positioning.
30. The bone screw according to claim 25 wherein: a) said capture
structure engages said shank upper capture portion substantially
below said integral upper rod engaging structure, such that only
said shank receives a direct downward force when said rod is biased
against said shank.
31. In an implant assembly including a bone screw and a rod wherein
said bone screw has a head with a rod receiving channel and a shank
with an integral lower portion adapted to be secured to a bone and
an integral upper portion pivotally received in said head during
positioning, the improvement comprising wherein: a) said shank is
uploaded into said head and said shank upper portion extends
substantially into said channel when said shank upper portion is
received in said head and directly engages said rod so that biasing
of said rod downward against said shank operably locks said shank
in position relative to said head before said rod fully seats in a
bottom of said channel and such that said shank first receives a
downward force thereon upon downward biasing of said rod and then
transfers the downward force from the shank to lock the shank in a
fixed position relative to the head; and b) a capture ring sized
and shaped to mate with said shank upper portion and pivoting with
said shank upper portion during polyaxial rotation of said shank
relative to said head.
32. The assembly according to claim 31 wherein: a) said shank is
cannulated along the entire length thereof.
33. In an implant assembly including a bone screw and a rod wherein
said bone screw has a head with a rod receiving channel and a shank
with a lower portion adapted to be secured to a bone and an upper
portion pivotally received in said head during positioning, the
improvement comprising wherein: a) said shank is cannulated along
the entire length thereof; and b) said shank upper portion projects
into said channel so as to directly engage said rod when said rod
is located in said channel and said shank is biased by said rod
when fully lowered in said channel so as to lock said shank in a
fixed position relative to said head; and c) a capture ring sized
and shaped to mate with said shank upper portion and pivoting with
said shank upper portion during polyaxial rotation of said shank
relative to said head.
34. The assembly according to claim 35 including a) a closure that
is rotatably mated with said head so as to bias against said rod
when rotated, such that said rod biases against said shank and
locks said shank in position relative to said head.
35. The assembly according to claim 33 wherein: a) only said shank
receives a downward force thereon upon downward biasing of said
rod.
36. A polyaxial bone screw comprising: a) a head having a channel
adapted to receive an elongate rod and having a lower bore; b) a
shank having a lower portion adapted to be implanted in a bone of a
patient and an upper portion; said shank being sized and shaped to
be loaded into said head and through said bore; c) a retainer ring
separate from said shank and received in said head; said retainer
ring cooperating with said shank upper portion so as to polyaxially
rotate with said shank relative to said head during positioning of
said shank relative to said head prior to locking of the position
of said shank relative to said head, said retainer ring presenting
a head engaging surface diameter larger than said head lower bore
so as to hold said shank in said head while allowing polyaxial
movement of said shank relative to said head during positioning; d)
said shank upper portion being sized and shaped so as to extend
into said channel after said shank is received in said head; and e)
said shank upper portion includes an engagement end positioned and
shaped so as to be adapted to abut against a rod placed in said
channel.
37. The bone screw according to claim 36 wherein: a) said
engagement end is convex.
38. The assembly according to claim 36 wherein: a) only said shank
receives a downward force thereon upon downward biasing of said
rod.
39. A polyaxial bone screw assembly comprising: a) an elongate rod;
b) a head having a channel receiving said rod during use and having
a lower bore and a lower opening; c) a shank having a lower portion
adapted to be implanted in a bone of a patient and an upper
portion; said shank upper portion being sized and shaped to be
loaded into said head and through said lower opening; d) a retainer
ring separate from said shank and received in said head; said
retainer ring mating with and secured to said shank upper portion
so as to rotate together with said shank relative to said head
during positioning and so as to form a subassembly prior to locking
of the position of said shank relative to said head, said
subassembly presenting a head engaging surface diameter larger than
said head lower bore so as to hold said shank in said head while
allowing polyaxial movement of said shank relative to said head
during positioning; e) said shank upper portion being sized, shaped
and positioned so as to receive a downward force transferred
through a rod placed into said channel after said shank is received
in said head; f) a closure including a mating structure for mating
with said head and closing said channel so as to be adapted to
capture said rod in said channel; g) said closure is positioned in
said head and engages said head; and wherein h) said shank upper
portion is shaped and positioned such that upon assembly of said
bone screw and said rod, said shank upper portion directly receives
said force, said force being generated by said closure that causes
frictional engagement of said ring with said head so as to secure
said shank in a selected fixed angular configuration relative to
said head.
40. The polyaxial bone screw assembly according to claim 39
wherein: a) said shank being sized, shaped and positioned in said
head so as to directly receive said downward force from above when
a rod is placed in said channel.
41. The polyaxial bone screw assembly according to claim 39
wherein: a) said ring engaging said shank upper portion
substantially below a top surface thereof; wherein only said shank
receives said downward force.
42. In a polyaxial bone screw having a shank and a head having an
inner chamber with an internal curvate surface and also having a
lower opening; the improvement comprising: a) said chamber internal
surface having a larger dimension than said opening; b) said shank
having an upper portion that has a smaller width than said opening
to allow said shank to be uploaded through said opening; c) a rod
receiving channel located above said chamber; said shank extending
into said channel so as to engage a rod in said channel during use;
and d) a retaining structure that loads separately from said shank
into said chamber and captures said shank in said chamber; said
retaining structure being secured to and rotating with said shank
relative to said head and having a lower surface sized and shaped
to slidingly mate and rotate with said chamber internal surface
during positioning.
43. In a polyaxial bone screw having a shank and a head; the
improvement comprising: a) said head having a lower aperture and
said shank being sized and shaped so as to allow uploading of an
upper portion of said shank through said aperture into said head;
and b) retaining structure that is non-integral with said shank and
loaded into said head separately from said shank; said retaining
structure mating with and being secured to said shank so as to
capture and pivot with said shank upper portion in said head so as
to allow polyaxial movement of said shank relative to said
head.
44. A polyaxial bone screw assembly comprising: a) a head having a
channel adapted to receive an elongate longitudinal member and
having a lower restrictive neck; b) a shank having a lower portion
adapted to be implanted in a bone of a patient and an upper
portion; said shank upper portion being sized and shaped to be
positioned in said head so as to extend through said lower
restrictive neck; c) a retainer ring separate from said shank and
received in said head; said retainer ring mating with and
non-pivotably coupled to said shank upper portion said shank and
said retainer ring when coupled being polyaxially rotatable
together relative to said head prior to locking of the position of
said shank relative to said head, said retainer ring width being
larger than a width of said head lower restrictive neck so as to
hold said shank upper portion in said head while allowing polyaxial
movement of said shank relative to said head during positioning;
and d) said shank upper portion being sized, shaped and positioned
so as to receive a downward force from said longitudinal member
after said longitudinal member is received in said head channel, so
as to lock the position of the shank relative to the head channel
thereby locking the position of the shank and head relative to each
other.
45. A polyaxial bone screw assembly comprising: a) an elongate
member; b) a head having a channel to receive the elongate
longitudinal member and having a lower restrictive neck; c) a shank
having a lower portion adapted to be implanted in a bone of a
patient and an upper portion; said shank upper portion being sized
and shaped to be positioned in said head so as to extend through
said lower restrictive neck; d) a retainer ring separate from said
shank and received in said head; said retainer ring mating with and
non-pivotably coupled to said shank upper portion; said upper shank
and said retainer ring when coupled being polyaxially rotatable
together relative to said head prior to locking of the position of
said shank relative to said head, said retainer ring width being
larger than a width of said head lower restrictive opening so as to
hold said shank upper portion in said head while allowing polyaxial
movement of said shank relative to said head during positioning;
and e) the upper portion being sized and shaped to extend upward
and so as to be located beneath the elongate member, when the
elongate member is received in the channel; when the assembly is
fully assembled, the elongate member operably transferring a
downward force to the shank upper portion, so as to urge the
coupled shank and retainer ring into frictional contact with head
and so as to lock the configuration of the shank with respect to
the head.
46. In a polyaxial bone screw having a shank and a head with a
channel sized and shaped to receive a rod; the improvement
comprising: a) said shank being sized and shaped to allow uploading
of said shank into said head such that said shank is positioned
directly beneath and receives a downward force from a rod located
in said channel; a retaining ring that is non-integral with said
head and said shank for capturing said shank in said head; said
ring being secured to said shank while in said head and pivoting
together with said shank during positioning of said shank relative
to said head, wherein said ring only engages said shank and said
head.
Description
RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 10/818,554, filed Apr. 5, 2004, now U.S. Pat.
No. ______, which is a continuation of U.S. patent application Ser.
No. 10/464,663, filed Jun. 18, 2003, now U.S. Pat. No. 6,716,214,
and a continuation-in-part of U.S. patent application Ser. No.
10/651,003, filed Aug. 28, 2003, now U.S. Pat. No. ______, each of
which is incorporated herein in its entirety by reference.
BACKGROUND OF THE INVENTION
[0002] The present invention is directed to a polyaxial bone screw
for use in spinal surgery and the like and especially to such a
screw adapted to receive a rod member and secure the rod member to
a vertebra or the like.
[0003] Many spinal surgery procedures require securing various
implants to bone and especially to vertebrae along the spine. For
example, elongate rods are often required that extend along the
spine to provide support to vertebrae that have been damaged or
weakened due to injury, disease or the like. Such rods must be
supported by certain vertebra and support other vertebra. The most
common mechanism for providing such structure is to implant bone
screws into certain bones which then in turn support the rod or are
supported by the rod. Bone screws of this type may have a fixed
head relative to a shank thereof. In the fixed bone screws, the
head cannot be moved relative to the shank and the rod must be
favorably positioned in order for it to be placed within the head.
This is sometimes very difficult or impossible to do so polyaxial
bone screws are commonly used. The polyaxial bone screws allow
rotation of the head about the shank until a desired rotational
position is achieved for the head relative to the shank after which
the rod can be inserted and the position of the head eventually
locked with respect to movement relative to the shank.
[0004] The present invention is directed to such swivel head type
bone screws and, in particular, to swivel head bone screws having
an open head that allows placement of the rod member within the
head and then subsequent closure by use of a closure top, plug or
the like to capture the rod in the head of the screw.
[0005] Because such implants are for placement within the human
body, it is always desirable for the implant to have as little
effect on the body as possible. Consequently, it is quite desirable
for the implants to have a relatively small profile both in height
and width. It is also desirable that the implants be
lightweight.
[0006] Furthermore, it is desirable that the swivel head implants
be unlikely to unintentionally disassemble within the body. It is
very undesirable for pieces of the implant to be free to move
around within the body after surgery is completed and it also
assures that the implant retains an ability to correct the
structural problem for which it was implanted. Furthermore, if the
implant should slip or become loose for some reason, it is still
desirable for all of the parts to remain together and not
separate.
[0007] Consequently, it is desirable for there to be a lightweight,
low profile polyaxial bone screw which assembles in such a manner
that each subsequent piece locks proceeding pieces within the
overall structure, so that there is less likelihood that the
various pieces of the structure will undesirably disassemble.
SUMMARY OF THE INVENTION
[0008] The present invention is directed to a polyaxial bone screw
or structure that comprises a shank, a head and a retainer ring
that operably cooperate with each other. The bone screw is designed
to allow the shank to be locked or secured in a selected angular
configuration with respect to the head, while the head receives a
rod member and while the shank is implanted in a bone, such as a
vertebra or vertebral body.
[0009] The shank has an implant body which includes an external
helically wound thread that is in turn attached by a neck to a
capture end with a capture or connector type structure. The capture
structure is positioned outside the bone in use and has a radiused
and cylindrically shaped radially outer surface that has at least
one radially outwardly extending non helically wound projection or
spline thereon. The capture structure also has an upper axially
aligned and radiused dome that protrudes above the remainder of the
shank and above the ring during use to manipulate the shank and to
contact the rod. Further, in some embodiments the shank includes
off axis apertures, grooves, side slots or the like for use by an
installation tool with a mating configured head for driving and
rotating the shank into the bone.
[0010] The head has a generally cylindrical shaped profile with an
upwardly open U-shaped channel formed therein so as to effectively
produce a lower base with two upstanding and spaced arms. The inner
surfaces of the arms have a threadform thereon or another suitable
guide and advancement structure such as a helically wound
flangeform for use in closing the upper part of the channel.
Located in the interior of the base and coaxially aligned with the
head is a chamber having an interiorly facing partial spherical
shaped surface. The chamber further opens onto a bottom surface of
the head through a head lower wall bore forming a constricted or
restrictive neck sized and shaped to allow passage of the capture
structure therethrough.
[0011] The retainer ring includes an external partial spherical or
hemispherical surface that is sized and shaped to be seated in and
slidably engage the partial spherical surface within the head, both
having approximately the same radius of generation. The ring also
has an internal, centrally located and axially extending ring bore
sized and shaped to receive the capture structure of the shank
therethrough. Further, the ring has a series of axially extending
channels positioned about and opening into the central bore that
are sized and shaped to allow sliding passage of the shank splines
entirely through the ring so that the shank can be inserted through
the ring while the ring is positioned within the chamber in the
head. The channels are not helically wound about the bore and
preferably extend vertically or parallel to the axis of the ring.
The ring further includes a set of recesses that are
circumferentially spaced from the channels and that open onto the
upper part of the ring and into the bore, but do not pass entirely
through the ring and that can be entered by the splines by drawing
the shank with the splines thereon axially downwardly with respect
to the ring. In this manner, the splines can be passed upwardly or
uploaded through the ring by sliding through the channels in
conjunction with the remainder of the shank capture and after
sliding completely through the bore, the shank is then rotated a
certain number of degrees relative to the head, and then drawn back
downwardly or downloaded so that the splines encounter and engage
the recesses wherein the splines are captured by the ring. The
splines preferably have a wedge-shaped surface thereon which pushes
not only downwardly, but radially outward against the retainer or
capture ring when force is applied to the top of the shank.
[0012] During assembly, the ring is placed through the U-shaped
channel into the chamber having the partial spherical surface and
then rotated so that the ring hemispherical surface mates with and
slidably engages the head partial spherical surface. Subsequently,
the shank capture structure is uploaded into and extended through
the ring central bore, while the splines pass through the channels.
The shank is then rotated relative to the ring and then the shank
is moved in an axially reverse direction opposed to uploading while
the splines are positioned over the recesses so as to be aligned
with the recesses and not aligned with the channels and so that the
splines then enter the recesses. The ring with connected shank
effectively thereafter form a ball and socket joint with the head
and allow free rotation to a selected angular configuration until
later locked in the selected configuration. The shank, head and
ring are then placed in a bone by screwing the shank body into the
bone using the apertures on the top of the shank or alternative
structure such as grooves or faceted surfaces on the outside of the
portion of the shank extending above the ring.
[0013] Thereafter, a rod is placed in the U-shaped channel and
captured therein by closing the channel by use of a closure top or
plug having a threadform or other external guide and advancement
structure that mates with and advances along mating guide and
advancement structure of the arms of the head, when the closure top
is rotated. Preferably, the closure top also includes a break-off
head that provides purchase for a tool for rotation and torquing of
the closure top to a preselected torque and that such torque is
transferred and applied as pressure against the rod received in the
head. Once the preselected torque is achieved, the break-off head
breaks away from the closure top. Under pressure from the closure
top, the rod pushes against the dome of the shank that extends
above the ring and thereby urges the splines downwardly. Because of
the wedge shaped structure of the splines, the splines push both
downwardly and outwardly upon the retainer or capture ring, when
force is applied to the dome, so as to frictionally engage and
positively seat the retaining ring in the cavity and prevent
further rotation in conjunction with the shank dome frictionally
engaging the rod under pressure. In particular, the hemispherical
surface of the ring abuttingly and frictionally mates with the
integral hemispherical interior facing surface of the head, while
the dome frictionally mates with the rod under pressure from the
rod so as to lock the shank and ring in a selected angular
configuration relative to the head. The shank, in this manner, can
be locked in a configuration selected from an infinite number of
angular configurations with respect to the head. Once fully
assembled in this manner, unless a part breaks into pieces, the
shank cannot disengage from the capture ring and the head without
disassembly of the device by reversing the process or breaking the
parts.
OBJECTS AND ADVANTAGES OF THE INVENTION
[0014] Therefore, the objects in the present invention are: to
provide a polyaxial bone screw having a bone implantable shank that
can be locked in a fixed position relative to a head of the bone
screw; to provide such a bone screw having a capture or retaining
ring having a partial external hemispherical surface that seats
within a partial internal spherical shaped chamber surface within
and integrally formed with a head of the bone screw to form a ball
and socket joint and wherein the shank is securable to the
retaining ring; to provide such a bone screw wherein the shank has
at least one spline that extends radially outward from a capture
end thereof and wherein the retaining ring has a central bore that
receives the capture end while a channel opening into the bore
allows the spline to slide through the ring so as to pass above the
ring, at which time the shank can be rotated a select number of
degrees and further wherein the retaining ring has a capture recess
that receives the spline on further downward or reverse movement
along the axis of the shank relative to the retainer ring; to
provide such a bone screw wherein the shank has an upwardly
protruding radiused dome which has a radius that in one embodiment
is substantially less than the radius of the external hemispherical
surface on the retainer ring and that extends upwardly within the
head chamber so as to reduce height of the screw head and further,
is operably positioned so as to engage a rod member received in the
head so as to receive downward pressure from the rod during
assembly; to provide such a bone screw wherein a closure top is
used to close a channel in the bone screw head after receiving the
rod and to apply pressure to the rod member that in turn, exerts
pressure on the dome of the shank so as to urge each spline into an
abutting and tight relationship with the retaining ring and to urge
the retaining ring both downwardly and radially outwardly, so that
the external hemispherical surface on the retaining ring more
completely contacts and frictionally engages the internal spherical
surface within the chamber of the head thereby providing improved
mechanical fixation to prevent further rotation of the shank
relative to the head; to provide such a bone screw which has a
comparatively low profile and which is comparatively light in
weight; to provide such a bone screw that resists disassembly
thereof except by removal of the closure top; to provide such a
bone screw wherein the closure top can be removed by the surgeon
should disassembly be desired at which time the entire structure
can be easily and quickly disassembled and removed from the bone,
if necessary; to provide such a bone screw wherein the shank is
locked in position relative to the head during usage in a locked or
fixed configuration; to provide such a bone screw wherein the shank
cannot disassemble from the head and the retaining ring once the
screw is fully assembled except if the closure top is removed and
the device is disassembled by the surgeon; to provide such a bone
screw which is easy to use and extremely effective for the intended
usage thereof.
[0015] Other objects and advantages of this invention will become
apparent from the following description taken in conjunction with
the accompanying drawings wherein are set forth, by way of
illustration and example, certain embodiments of this
invention.
[0016] The drawings constitute a part of this specification and
include exemplary embodiments of the present invention and
illustrate various objects and features thereof.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] FIG. 1 is an exploded perspective view of three elements of
a polyaxial bone screw in accordance with the present invention,
including a shank, a head, and a retaining ring.
[0018] FIG. 2 is an enlarged top plan view of the retaining
ring.
[0019] FIG. 3 is an enlarged perspective view of the retaining
ring.
[0020] FIG. 4 is an enlarged side elevational view of the retaining
ring.
[0021] FIG. 5 is an enlarged bottom plan view of the retaining
ring.
[0022] FIG. 6 is an enlarged cross-sectional view of the head,
taken along line 6-6 of FIG. 1, illustrating the retaining ring
being inserted into the head.
[0023] FIG. 7 is an enlarged cross-sectional view of the head
similar to FIG. 6, showing the retaining ring seated in the
head.
[0024] FIG. 8 is a cross-sectional view of a vertebra illustrating
the shank implanted therein.
[0025] FIG. 9 is an enlarged and fragmentary perspective view of
the shank, head and retainer ring during assembly and just prior to
the retainer ring being placed over the shank.
[0026] FIG. 10 is an enlarged, fragmentary and perspective
cross-sectional view of the head similar to FIG. 6, illustrating
splines on a capture end of the shank that have been inserted
through channels in the retainer ring and are positioned upwardly
in the head above the retainer ring.
[0027] FIG. 11 is a cross-sectional view of the head, similar to
FIG. 10, showing the upper capture end of the shank with the
splines lowered into receiving recesses in the ring and positioned
therein.
[0028] FIG. 12 is a cross sectional view of the head and a top plan
view of the shank and ring corresponding to the positioning shown
in FIG. 10.
[0029] FIG. 13 is a cross sectional view of the head and a top plan
view of the shank and ring corresponding to the positioning shown
in FIG. 11.
[0030] FIG. 14 is a side elevational view of the head, ring and
shank, illustrating the shank swinging or rotating from one
position shown in solid lines to a second position shown in phantom
lines.
[0031] FIG. 15 is a fragmentary and partially exploded view of a
complete polyaxial bone screw assembly, prior to final assembly and
illustrating a rod received in the head and a closure top with a
break-off head, prior to the closure top being rotatably inserted
into the head
[0032] FIG. 16 is a fragmentary and enlarged front elevational view
of the bone screw assembly fully assembled and illustrating the
head with the rod received therein and with the closure top fully
inserted and biasing against the rod that in turn biases against
the top of the shank.
[0033] FIG. 17 is an enlarged and fragmentary cross-sectional view
of the bone screw assembly with rod inserted therein, taken along
line 17-17 of FIG. 16.
[0034] FIG. 18 is an enlarged cross-sectional view of the vertebra,
head, rod and closure top, taken along line 18-18 of FIG. 17
showing the shank implanted in the vertebra and with the bone screw
assembly in a completely assembled and operational configuration
with the shank locked in an angled orientation with respect to the
head.
[0035] FIG. 19 is a perspective view of a modified retainer ring of
a first modified embodiment in accordance with the present
invention
[0036] FIG. 20 is a perspective view of a second modified
embodiment of the present invention illustrating a cannulated shank
having four splines and a hex tool engageable head for manipulating
the shank.
[0037] FIG. 21 is a perspective view of a ring for use in
accordance with the second modified embodiment of the invention and
the shank of FIG. 20.
DETAILED DESCRIPTION OF THE INVENTION
[0038] As required, detailed embodiments of the present invention
are disclosed herein; however, it is to be understood that the
disclosed embodiments are merely exemplary of the invention, which
may be embodied in various forms. Therefore, specific structural
and functional details disclosed herein are not to be interpreted
as limiting, but merely as a basis for the claims and as a
representative basis for teaching one skilled in the art to
variously employ the present invention in virtually any
appropriately detailed structure.
[0039] The reference number 1 generally represents a polyaxial bone
screw apparatus or assembly in accordance with the present
invention operably utilized by implantation into a vertebra 2 and
in conjunction with a longitudinal member or rod 3 so as to
operably secure the rod 3 in a fixed position relative with respect
to the vertebra 2.
[0040] The fully assembled bone screw assembly 1 comprises a shank
6, a head 7, a retainer ring 8 and a closure top 9. The shank 6 is
perhaps best seen in FIGS. 1 and 8. The shank 6 is elongate and has
a lower body 15 ending in a tip 16. The shank body 15 has a
helically wound bone implantable thread 17 extending from near the
tip 16 to near the top 18 of the body 15 and extending radially
outward therefrom. During use, the body 15 utilizing the thread 17
is implanted into the vertebra 2, as is seen in FIG. 18. The shank
6 has an elongated axis of rotation generally identified by the
reference letter A. It is noted that the reference to the words top
and bottom as used herein refers to the alignment shown in the
various drawings, as well as the normal connotations applied to
such devices, and is not intended to restrict positioning of the
assembly 1 in actual use.
[0041] Axially extending outward and upward from the shank body 15
is a neck 20 of reduced radius as compared to the adjacent top 18
of the body 15. Further extending axially and outwardly from the
neck 20 is a capture end or structure 21 operably providing a
connective or capture structure free from the bone or vertebra 2
for joining with the head 7. The capture structure 21 has a
radially outer cylindrical surface 22. The cylindrical surface 22
has at least one non-helically wound and radially outward extending
projection or spline 24 that extends beyond the surface 22. In the
embodiment shown in FIGS. 1 through 18, the capture structure 21
has three such splines 24. The splines 24 are located near an upper
end 25 of the shank 6 and are equally circumferentially centered
and spaced thereabout so as to be centered at approximately 120
degree intervals relative to each other. Each of the splines 24 has
a triangular shaped profile and a front wedge forming face 27 that
slopes downwardly and radially inwardly from near the upper end 25
of the shank 6. Also located on the shank upper end 25 is a
centrally located, axially extending and upwardly directed
projection or dome 29 that is centrally radiused so as to have a
first radius.
[0042] The shank upper end 25 still further includes at least one
tool engagement aperture for engagement by a tool driving head (not
shown) that is sized and shaped to fit into the apertures for both
driving and rotating the shank 6 into the vertebra 2. In the
illustrated embodiment, a pair of apertures 31 located in spaced
relationship to each other, the dome 29 and the shank axis of
rotation A are located on the shank upper end 25. The apertures 31
extend into the shank capture structure 21 parallel to the axis A.
It is foreseen that various numbers of apertures, slots or the like
may be utilized in accordance with the invention for engaging the
driving tool of suitable and similar mating shape, or that the
outer surface of the upper axial projection can be grooved or
formed with a faceted surface that can be driven by a mating tool
that goes over the surface.
[0043] The head 7 has a generally cylindrical shaped profile, as is
seen in FIG. 1, although the head 7 is not a solid cylinder. The
head 7 has a base 33 with a pair of upstanding arms 34 and 35
forming a U-shaped channel 38 between the arms 34 and 35 with a
lower seat 39 having substantially the same radius as the rod 3 for
operably snugly receiving the rod 3. Each of the arms 34 and 35 has
an interior surface 41 that includes a partial helically wound
guide and advancement structure 42. In the illustrated embodiment,
the guide and advancement structure 42 is a partial helically wound
flangeform which will mate under rotation with a similar structure
on the closure top 9, as described below. However, it is foreseen
that the guide and advancement structure 42 could alternatively be
a V-shaped thread, a buttress thread, a reverse angle thread or
other thread like or non-thread like helically wound advancement
structures for operably guiding under rotation and advancing the
closure top between the arms 34 and 35. Tool engaging apertures 44
are formed on the outsides of the arms 34 and 35 for holding the
head 7 during assembly.
[0044] A chamber or cavity 47 is located within the head base 33
that opens upwardly into the U-shaped channel 38. The cavity 47
includes a partial spherical shaped surface 48, at least a portion
of which forms a partial internal hemispherical seat 49 for the
ring 8, as is described further below. A bore 52 further
communicates between the cavity 47 and the bottom exterior of the
base 33 and is coaxial with a rotational axis B of the head 7. The
bore 52 at least partially defines a restrictive neck 54 that has a
radius which is smaller than the radius of the ring 8, as will be
discussed further below, so as to form a restrictive constriction
at the location of the neck 54 relative to the retainer ring 8 to
prevent the ring 8 from passing between the cavity 47 and the lower
exterior of the head 7. A bevel 55 extends between the neck 54 and
the bottom exterior of the base 33. The hemispherical shaped
surface 48 has a second radius associated therewith.
[0045] The retainer ring 8 which is best seen in FIGS. 2 through 5
has an operational central axis which is the same as the elongate
axis A associated with the shank 6, but when the ring 8 is
separated from the shank 2, the axis of rotation is identified as
axis C, such as in FIG. 4. The retainer ring 8 has a central bore
57 that passes entirely through the retainer ring 8 from a top
surface 58 to a bottom surface 59 thereof. The bore 57 is sized and
shaped to fit snugly but slidably over the shank capture structure
cylindrical surface 22 in such a manner as to allow sliding axial
movement therebetween under certain conditions, as described below.
Three axially aligned channels 60 are spaced from the axis C and
extend radially outward from the bore 57 and into the wall of the
retainer ring 8 so as to form three top to bottom grooves or slots
therein. Backs 61 of the channels 60 are the same radial distance
from the axis C as the distance the outermost portion of the
splines 24 extend from the axis A of the shank 6. The channels 60
are also circumferentially angularly spaced equivalent to and have
a width that corresponds with the splines 24. In this manner, the
shank capture structure 21 can be uploaded into the ring 8 by
axially sliding the capture structure 21 through the ring central
bore 57 whenever the splines 24 are aligned with the channels 60 or
are in an aligned configuration, as seen in FIG. 12.
[0046] The retainer ring 8 also has three capture partial slots,
receivers or recesses 62 which extend radially outward from the
upper part the bore 57 and that do not extend the entire length
from top to bottom of the retainer ring 8, but rather only open on
the top surface 59 and extend partly along the height of the ring 8
thereof. The recesses 62 are sized and positioned and shaped to
receive the splines 24 from above when the splines 24 are in a
non-aligned configuration relative to the channels 60. That is,
each of the recesses 62 has a width that approximates the width of
the splines 24 and has a mating wedge engaging surface 64 that is
shaped similar to the spline wedge forming faces 27, so that the
splines 24 can be slidably received into the recesses 62 from above
by axially translating or moving the shank 6 downward relative to
the ring 8 when the splines 24 are positioned above the recesses 62
in a recess aligned configuration.
[0047] In some embodiments, the wedge engaging faces 64 slope
slightly greater than the wedge forming faces 27 on the splines 24
so that there is additional outward wedging that takes place when
the splines 24 are urged downwardly into the recesses 62, as
further discussed below.
[0048] In this manner the shank capture structure 21 can be
uploaded or pushed upwardly through the retainer ring central bore
57 so as to clear the top 58 of the retainer ring 8, rotated
approximately 60 degrees and then downloaded or brought downwardly
so that the splines 24 become located and captured in the recesses
62. Once the splines 24 are seated in the recesses 62 the shank 6
cannot move further axially downward relative to the ring 8.
Preferably, the retainer ring 8 is constructed of a metal or other
material having sufficient resilience and elasticity as to allow
the ring 8 to radially expand slightly outward by downward pressure
of the splines 24 on the recesses 62 under pressure from structure
above, as will be discussed further below. This produces a slight
outward radial expansion in the ring 8 at the location of the
recesses 62.
[0049] The ring 8 has a radially outer partial hemispherical shaped
surface 65 sized and shaped to mate with the partial spherical
shaped surface 48 and having a third radius approximately equal to
the second radius associated with the surface 48. The ring third
radius is substantially larger than the first radius associated
with the dome 29 and also substantially larger than the radius of
the neck 54.
[0050] The longitudinal member or elongate rod 3 can be any of many
different types of implants utilized in reconstructive spinal
surgery and the like, but is normally a cylindrical elongate
structure having a cylindrical surface 66 of uniform diameter. The
rod 3 is preferably sized and shaped to snugly seat near the bottom
of the U-shaped channel 38 and, during normal operation, will be
positioned slightly above the bottom of the channel 38. In
particular, the rod 3 normally engages the shank dome 29, as is
seen in FIG. 16 and urges the dome 29 and, consequently, the shank
6 downwardly when the entire assembly 1 is fully assembled.
[0051] The closure top 9 can be any of the variety of different
types of closure tops for use in conjunction with the present
invention with suitable mating structure on the upstanding arms 34
and 35. The illustrated closure top 9 has a generally cylindrical
shaped base 67 with an upwardly extending break-off head 68. The
base 67 includes a helically wound guide and advancement structure
71 that is sized, shaped and positioned so as to engage the guide
and advancement structure 42 on the arms 34 and 35 to allow the
closure top 9 to be rotated into the head 7 and, in particular, to
close the top of the U-shaped channel 38 to capture the rod 3, see
FIG. 16, preferably without splaying of the arms 34 and 35. The
closure top 9 also operably biases against the rod 3 by advancement
and applying pressure to the rod 7 under torquing, so that the rod
3 is urged downwardly against the shank dome 29. Downward biasing
of the shank dome 29 operably produces a frictional engagement
between the rod 3 and dome 29 and also urges the splines 24
downwardly to both bias downwardly and radially outwardly against
the retainer ring 8, so as to snugly and frictionally seat the
retainer ring external hemispherical surface 65 into and quite
tightly against the partial internal spherical surface 48 of the
head 7 and further so as to lock the shank 6 and retainer ring 8 in
a fixed position relative to the head 7.
[0052] The closure top break-off head 68 is secured to the base 67
at a neck 73 that is sized and shaped so as to break away at a
preselected torque that is designed to properly seat the retainer
ring 8 in the head 7. The break-off head 68 includes an external
faceted surface 75 that is sized and shaped to receive a
conventional socket head of a driving tool (not shown) to rotate
and torque the closure top 9. The break-off head 68 also includes a
central bore 77 and grooves 78 for operably receiving the
manipulating tools.
[0053] The closure top 9 also includes removal structure comprising
a pair of off axis pass through apertures 81 that extend from top
to bottom of the base 67. The apertures 81 are located parallel to
an axis of rotation axis D of the closure top 9, but are radially
spaced away therefrom. The apertures 81 become accessible from the
top of the base 67 after the break-off head 68 breaks away from the
base 67, as is seen in FIG. 18. The apertures 81 are designed to
receive a tool having a face that mates with and is insertable into
the apertures 81 for rotating the closure top base 67 subsequent to
installation so as to provide for removal, if necessary.
[0054] While the embodiment illustrated in FIGS. 1 through 18
includes three splines 3, it is foreseen that a shank 6 with a
single spline would be operable within the scope of the invention.
However, in some embodiments additional splines 3 may provide a
more even distribution of force upon the ring 8 and reduce the
likelihood of failure because of hoop strain or the like. Paired
and opposed splines in certain embodiments may provide a more even
distribution of forces. While any number of splines are foreseen as
possible for use under the present invention, the requirement that
the splines must get smaller as their number gets larger, limits
the maximum number at some point. However, the concept appears
viable until that point is reached. It is also noted that
additional channels and recesses allow the ring to be more elastic
in certain embodiments.
[0055] When the polyaxial bone screw assembly 1 is placed in use in
accordance with the invention the retainer ring 8 is normally first
slid through the head U-shaped channel 38, as is shown in FIG. 6,
and into and seated in the chamber 47, as is seen in FIG. 6.
Thereafter, the retainer ring 8 is rotated 90 degrees so as to be
coaxial with the head 7 and so that the retainer ring outer surface
65 snugly but slidably mates with the head interior spherical
shaped surface 48, as is seen in FIG. 7.
[0056] With reference to FIGS. 9, 10, and 12 the ring 8 in the head
7 is slid over the shank capture structure 21 so that the splines
24 slide upwardly through and above respective channels 60 so that
the splines 24 are then located, at least partially, in the
U-shaped channel 38 and chamber 47 above the retainer ring 8, as is
shown in FIG. 10. The shank 6 is then rotated 60 degrees relative
to the head about the axis A and the translational direction of the
shank 6 is reversed so that it goes downwardly or axially with
respect to the head 7, as is seen in FIGS. 11 and 13 and the
splines 24 enter the recesses 62. At this point there is no
substantial outward or downward pressure on the retainer ring 8 and
so the retainer ring 8 is easily rotatable along with the shank 6
within the chamber 47 and such rotation is of a ball and socket
type limited by engagement of the shank neck 20 with the ring
restrictive neck 54. Rotation is shown in FIG. 14 where it is
illustrated that the shank 6 can be rotated through a substantial
angular rotation relative to head 7, both from side to side and
from front to rear so as to substantially provide a universal or
ball joint wherein the angle of rotation is only restricted by
engagement of the neck 20 with the neck 54 on the head 7.
[0057] The assembly 1 is then normally screwed into a bone, such as
vertebra 2, by rotation of the shank 6 using a suitable driving
tool (not shown) that operably drives and rotates the shank 6 by
engagement thereof at the apertures 31. The relative position of
the shank 6 is shown in FIG. 8 with a phantom vertebra 2. Normally,
the head 7 and ring 8 are assembled on the shank 6 before placing
the shank 6 in the vertebra 2, but in certain circumstances, the
shank 6 can be first implanted with the capture structure 21
extending proud to allow assembly and then the shank 6 can be
further driven into the vertebra 2.
[0058] A rod 3 is eventually positioned within the head U-shaped
channel 38, as is seen in FIG. 15, and the closure top 9 is then
inserted into and advanced between the arms 34 and 35 so as to bias
or push against the rod 3. The break-off head 68 of the closure top
9 is torqued to a preselected torque, for example 90 inch pounds,
to urge the rod 3 downwardly. The shank dome 29, because it is
radiused and sized to extend upwardly into the U-shaped channel 38,
is engaged by the rod 3 and pushed downwardly when the closure top
9 pushes downwardly on the rod 3, as is seen in FIG. 16. The
downward pressure on the shank 6 in turn urges the splines 24
downwardly which exerts both a downward and outward thrust on the
retainer ring 8, as is seen in the configuration shown in FIG. 17.
The polyaxial bone screw assembly 1 including rod 3 and shown
positioned in a vertebra 2 is illustrated in FIG. 18. The axis A of
the bone screw shank 6 is illustrated as not being coaxial with the
axis B of the head 7 and the shank 6 is locked in this angular
locked configuration. Other angular configurations can be achieved,
as required during installation surgery due to positioning of the
rod 3 or the like.
[0059] If removal of the assembly 1 is necessary, the assembly 1
can be disassembled by using a driving tool mating with the closure
top apertures 81 to rotate the base 67 and reverse the advancement
thereof in the head 7 and then disassembly of the remainder of the
assembly 1 in reverse mode in comparison to the procedure described
above for assembly.
[0060] Illustrated in FIG. 19 is a second embodiment of a retainer
ring 88 in accordance with the present invention. The retainer ring
88 is quite similar to the retainer ring 8 of the previous
embodiment except that it is noncontinuous and has a radially
extending space or gap 90 from top to bottom along one side
thereof. The gap 90 allows for expansion without requiring
stretching of the material of construction of the ring 88, as is
the case with the previous embodiment. The ring 88 includes a
central bore 92, spline channels 93 and spline receivers 94 which
are all similar to the similar structures described for the
previous embodiment. The retainer ring 88 also has a partial
hemispherical shaped surface 95 on the outer side thereof.
[0061] Illustrated in FIGS. 20 and 21 are elements of a third
embodiment of the present invention including a shank 106 and a
capture ring 107 which are used otherwise in the same manner as has
been described in the first embodiment and, in particular, with a
head such as head 7 which is not further described herein. The
shank 106 is similar to the shank 6 in that it has a body 110 with
a helically round thread 111 thereon and a capture structure 114
joined to the body 110 by a neck 115. The principle differences
between the present embodiment and the first embodiment is that the
capture structure 114 includes four splines 120 that are similar in
shape to the splines 24 of the first embodiment, but the splines
120 are centered and located at 90 degrees from one another such
that there is a pairing of opposed splines 120 and the dome of the
prior embodiment is replaced with an axial extension 122. Each of
the splines 120 includes a wedge face 121. The extension 122 has a
faceted surface 123 that extends parallel to the axis of the shank
106 and that is sized and shaped to receive a hex head driving tool
(not shown) for driving the shank 106 into bone. The extension 123
also has a radiused upper surface 124. The shank 106 also has an
axial extending cannulation or bore 125 that extends entirely
through the length of the shank 106.
[0062] The capture ring 107, shown in FIG. 21, is otherwise similar
to the retainer ring 8 except that it includes a set of four
channels 126 and four recesses 127 that are sized shaped and
positioned so as with respect to the channels 126 to allow the
splines 120 to slidingly pass upwardly through and with respect to
the recesses 127 to capture and receive the splines 120, as they
move axially downwardly. The ring 107 has a partial hemispherical
outer surface 129 that mates with the corresponding surface in the
head 7 in the manner described for the first embodiment.
[0063] It is to be understood that while certain forms of the
present invention have been illustrated and described herein, it is
not to be limited to the specific forms or arrangement of parts
described and shown.
* * * * *