U.S. patent application number 09/944662 was filed with the patent office on 2002-03-14 for multi-angle bone screw assembly using shape-memory technology.
Invention is credited to Drewry, Troy, Sherman, Michael C..
Application Number | 20020032443 09/944662 |
Document ID | / |
Family ID | 24992586 |
Filed Date | 2002-03-14 |
United States Patent
Application |
20020032443 |
Kind Code |
A1 |
Sherman, Michael C. ; et
al. |
March 14, 2002 |
Multi-angle bone screw assembly using shape-memory technology
Abstract
In one embodiment, a spinal fixation assembly includes an
elongated member, such as a spinal rod, configured for placement
adjacent the spine and a bone engaging fastener, such as a bone
screw having a lower portion configured for engaging a vertebra and
a head that is at least partially spherical. The assembly further
includes a receiver member defining a bore therethrough from a top
end to a bottom end, a recess for receiving the head of the bone
screwing fastener therein, and a lower opening at said bottom end
of the receiver member through which the bone screw extends. The
recess is configured to at permit pivoting of the bone screw within
the receiver member until the head is fixed within the recess. The
receiver member also includes a channel communicating with the bore
and having an upper opening at the top end of the receiver member
for insertion of the spinal rod into the channel. In one
embodiment, two compression members are provided, each being formed
of a temperature responsive material and having a first
configuration at a first temperature and a different second
configuration at a different second temperature in which the
compression member contracts about a portion of the receiver member
to thereby compress the receiver member about both the head of the
bone screw within the recess and the spinal rod within the
channel.
Inventors: |
Sherman, Michael C.;
(Memphis, TN) ; Drewry, Troy; (Memphis,
TN) |
Correspondence
Address: |
Brad A. Schepers
Woodard, Emhardt, Naughton, Moriarty and McNett
Bank One Center/Tower
111 Monument Circle, Suite 3700
Indianapolis
IN
46204-5137
US
|
Family ID: |
24992586 |
Appl. No.: |
09/944662 |
Filed: |
August 31, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09944662 |
Aug 31, 2001 |
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09595047 |
Jun 12, 2000 |
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6287311 |
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09595047 |
Jun 12, 2000 |
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09313842 |
May 17, 1999 |
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6132434 |
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09313842 |
May 17, 1999 |
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09042911 |
Mar 17, 1998 |
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5954725 |
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09042911 |
Mar 17, 1998 |
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08744403 |
Nov 7, 1996 |
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5728098 |
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Current U.S.
Class: |
606/278 ;
606/264; 606/911 |
Current CPC
Class: |
A61B 17/7038 20130101;
A61B 2017/00867 20130101; A61B 17/7032 20130101; Y10S 606/911
20130101; A61B 17/7037 20130101; Y10S 411/909 20130101 |
Class at
Publication: |
606/61 |
International
Class: |
A61B 017/56 |
Claims
What is claimed:
1. A spinal fixation assembly, comprising: an elongated member
configured for placement adjacent the spine; a bone engaging
fastener, said fastener having a lower portion configured for
engaging a vertebra and a head, said head being at least partially
spherical in configuration; a receiver member having a top end and
an opposite bottom end, said member defining a recess for receiving
said head of said bone engaging fastener therein, said recess
having a lower opening at said bottom end of said receiver member
through which said lower portion of said fastener extends, said
member also including a channel having an upper opening at said top
end of said receiver member, said channel being configured to
receive said elongated member therein; and a compression member
disposed around a portion of said receiver member, said compression
member being formed of a temperature responsive material and having
a first configuration at a first temperature and a different second
configuration at a different second temperature in which said
compression member contracts about said portion of said receiver
member to thereby compress said receiver member about said head of
said bone engaging fastener within said recess.
2. The spinal fixation assembly according to claim 1, wherein said
head of said bone engaging fastener includes a truncated upper
surface, and defines a tool receiving recess through said upper
surface.
3. The spinal fixation assembly according to claim 1, wherein: said
recess is disposed within said receiver member adjacent said bottom
end thereof; and said receiver member defines a outer annular lower
groove adjacent said bottom end, said groove configured to receive
said compression member when said compression member is in said
first configuration.
4. The spinal fixation assembly according to claim 3, wherein: said
receiver member includes an outer annular upper groove adjacent
said top end thereof; and said assembly includes a second
compression member configured to be received within said upper
groove.
5. The spinal fixation assembly according to claim 4, wherein said
second compression member is formed of a temperature responsive
material having a first configuration to be received within said
upper groove at substantially said first temperature and a
different second configuration at substantially said different
second temperature in which said second compression member
contracts about said receiver member.
6. The spinal fixation assembly according to claim 1, wherein: said
recess is disposed within said receiver member adjacent said bottom
end thereof; and said receiver member defines an outer annular
upper groove adjacent said top end, said groove configured to
receive said compression member when said compression member is in
said first configuration.
7. The spinal fixation assembly according to claim 1, wherein: said
recess is disposed adjacent said bottom end of said receiver
member; and said channel is disposed adjacent said top end of said
receiver member and is disposed apart from said recess so that said
head of said bone engaging fastener does not intersect said channel
when said head is disposed within said recess.
8. The spinal fixation assembly according to claim 7, wherein: said
assembly further including a second compression member formed of a
temperature responsive material having a first configuration at
substantially said first temperature and a different second
configuration at substantially said different second temperature in
which said second compression member contracts about said receiver
member; and said receiver member defines an outer annular upper
groove adjacent said top end thereof, said upper groove configured
to receive said second compression member therein when said second
compression member is in said first configuration, whereby said
second compression member contracts about said receiver member in
said different second configuration to compress said receiver
member about said elongated member disposed within said
channel.
9. The spinal fixation assembly according to claim 1, wherein said
receiver member includes opposite first side side walls defining
said channel and opposite second side walls intermediate said first
side walls.
10. The spinal fixation assembly according to claim 9, wherein said
receiver member includes a first slot defined in each of said
opposite second side walls, each said first slot extending from
said bottom end toward said top end of said receiver member.
11. The spinal fixation assembly according to claim 10, wherein
each said first slot intersects said recess.
12. The spinal fixation assembly according to claim 11, wherein
said first slot terminates at said recess.
13. The spinal fixation assembly according to claim 10, wherein
said receiver member includes a second slot defined in each of said
opposite first side walls, each said second slot extending from
said channel toward said bottom end of said receiver member.
14. The spinal fixation assembly according to claim 12, wherein
each said second slot intersects said recess.
15. The spinal fixation assembly according to claim 14, wherein
said second slot terminates at said recess.
16. The spinal fixation assembly according to claim 12, wherein
each said first slot intersects said recess.
17. The spinal fixation assembly according to claim 16, wherein
said first slot terminates at said recess.
18. The spinal fixation assembly according to claim 10, wherein
said receiver member includes a second slot defined in each of said
opposite first side walls, each said second slot extending from
said bottom end toward said top end of said receiver member.
19. The spinal fixation assembly according to claim 18, wherein
each said second slot intersects said recess.
20. The spinal fixation assembly according to claim 19, wherein
said second slot terminates between said recess and said top end of
said receiver member.
21. The spinal fixation assembly according to claim 20, wherein
said second slot terminates adjacent said channel.
22. The spinal fixation assembly according to claim 9, wherein said
receiver member includes a second slot defined in each of said
opposite first side walls, each said second slot extending from
said channel toward said bottom end of said receiver member.
23. The spinal fixation assembly according to claim 21, wherein
each said second slot intersects said recess.
24. The spinal fixation assembly according to claim 9, wherein said
receiver member includes a second slot defined in each of said
opposite first side wails, each said second slot extending from
said bottom end toward said top end of said receiver member.
25. The spinal fixation assembly according to claim 24, wherein
each said second slot intersects said recess.
26. The spinal fixation assembly according to claim 25, wherein
said second slot terminates between said recess and said top end of
said receiver member.
27. The spinal fixation assembly according to claim 26, wherein
said second slot terminates adjacent said channel.
28. The spinal fixation assembly according to claim 9, wherein said
opposite first side walls are substantially flat and said opposite
second walls are curved.
29. The spinal fixation assembly according to claim 1, wherein:
said elongated member is a rod having a rod diameter; and said
channel has a channel diameter substantially equal to said rod
diameter.
30. The spinal fixation assembly according to claim 29, wherein
said upper opening of said channel has a width that is less than
said rod diameter.
31. The spinal fixation assembly according to claim 29, wherein
said upper opening of said channel has a width that is
approximately equal to said rod diameter.
32. The spinal fixation assembly according to claim 1, wherein said
receiver member further defines a flared opening from said recess
to said bottom end of said member.
33. The spinal fixation assembly according to claim 1, wherein said
receiver member further defines a bore extending from said top end
of said receiver and communicating with said recess, said bore
intersecting said channel and having a bore diameter.
34. The spinal fixation assembly according to claim 33, wherein:
said elongated member is a rod having a rod diameter; and said
channel has a channel diameter substantially equal to said rod
diameter.
35. The spinal fixation assembly according to claim 34, wherein
said bore of said receiver member said bore diameter is greater
than said channel diameter.
36. The spinal fixation assembly according to claim 34, wherein
said bore of said receiver member said bore diameter is
approximately equal to said channel diameter.
37. The spinal fixation assembly according to claim 33;wherein said
receiver member further defines a flared opening from said recess
to said bottom end of said member.
38. The spinal fixation assembly according to claim 37, wherein
said flared opening intersects said recess at a lower diameter
greater than said bore diameter.
39. The spinal fixation assembly according to claim 37, wherein
said flared opening intersects said recess at a lower diameter
substantially equal to said bore diameter.
40. The spinal fixation assembly according to claim 1, wherein a
portion of said upper opening of said channel is angled outwardly
from said channel.
41. The spinal fixation assembly according to claim 1, wherein:
said receiver member defines a groove; and said compression member
is a ring sized to fit within said groove.
42. The spinal fixation assembly according to claim 41, wherein: a
portion of said groove is flat and a remaining portion of said
groove is curved; and said ring includes flat and curved portions
substantially corresponding to said flat and curved portions of
said lower groove.
43. The spinal fixation assembly according to claim 42, wherein
said ring is a closed ring that entirely encircles said receiver
member at said groove.
44. An assembly for engaging a bone engaging fastener having a head
to an elongated member, said assembly comprising: a receiver member
having a top end and an opposite bottom end, said member defining a
recess for receiving the head of the bone engaging fastener
therein, said recess having a lower opening at said bottom end of
said receiver member through which a lower portion of the fastener
extends, said member also including a channel having an upper
opening at said top end of said receiver member, said channel being
configured to receive the elongated member therein; and a
compression member disposed around a portion of said receiver
member, said compression member being formed of a temperature
responsive material and having a first configuration at a first
temperature and a different second configuration at a different
second temperature in which said compression member contracts about
said portion of said receiver member to thereby compress said
receiver member about the head of the bone engaging fastener within
said recess.
45. The spinal fixation assembly according to claim 44, wherein:
said recess is disposed within said receiver member adjacent said
bottom end thereof; and said receiver member defines a outer
annular lower groove adjacent said bottom end, said groove
configured to receive said compression member when said compression
member is in said fist configuration.
46. The spinal fixation assembly according to claim 42, wherein:
said receiver member includes an outer annular upper groove
adjacent said top end thereof; and said assembly includes a second
compression member configured to be received within said upper
groove.
47. The spinal fixation assembly according to claim 46, wherein
said second compression member is formed of a temperature
responsive material having a first configuration to be received
within said upper groove at substantially said first temperature
and a different second configuration at substantially said
different second temperature in which said second compression
member contracts about said receiver member.
48. The spinal fixation assembly according to claim 44, wherein:
said recess is disposed within said receiver member adjacent said
bottom end thereof; and said receiver member defines an outer
annular upper groove adjacent said top end, said groove configured
to receive said compression member when said compression member is
in said first configuration.
49. The spinal fixation assembly according to claim 44, wherein:
said recess is disposed adjacent said bottom end of said receiver
member; and said channel is disposed adjacent said top end of said
receiver member and is disposed apart from said recess so that the
head of the bone engaging fastener does not intersect said channel
when the head is disposed within said recess.
50. The spinal fixation assembly according to claim 49, wherein:
said assembly further including a second compression member formed
of a temperature responsive material having a first configuration
at substantially said first temperature and a different second
configuration at substantially said different second temperature in
which said second compression member contracts about said receiver
member; and said receiver member defines an outer annular upper
groove adjacent said top end thereof, said upper groove configured
to receive said second compression member therein when said second
compression member is in said first configuration, whereby said
second compression member contracts about said receiver member in
said different second configuration to compress said receiver
member about the elongated member disposed within said channel.
51. The spinal fixation assembly according to claim 44, wherein
said receiver member includes opposite first side side walls
defining said channel and opposite second side walls intermediate
said first side walls.
52. The spinal fixation assembly according to claim 51, wherein
said receiver member includes a first slot defined in each of said
opposite second side walls, each said first slot extending from
said bottom end toward said top end of said receiver member.
53. The spinal fixation assembly according to claim 52, wherein
each said first slot intersects said recess.
54. The spinal fixation assembly according to claim 53, wherein
said first slot terminates at said recess.
55. The spinal fixation assembly according to claim 54, wherein
said receiver member includes a second slot defined in each of said
opposite first side walls, each said second slot extending from
said channel toward said bottom end of said receiver member.
56. The spinal fixation assembly according to claim 55, wherein
each said second slot intersects said recess.
57. The spinal fixation assembly according to claim 56, wherein
said second slot terminates at said recess.
58. The spinal fixation assembly according to claim 56, wherein
each said first slot intersects said recess.
59. The spinal fixation assembly according to claim 58, wherein
said first slot terminates at said recess.
60. The spinal fixation assembly according to claim 52, wherein
said receiver member includes a second slot defined in each of said
opposite first side walls, each said second slot extending from
said bottom end toward said top end of said receiver member.
61. The spinal fixation assembly according to claim 60, wherein
each said second slot intersects said recess.
62. The spinal fixation assembly according to claim 61, wherein
said second slot terminates between said recess and said top end of
said receiver member.
63. The spinal fixation assembly according to claim 62, wherein
said second slot terminates adjacent said channel.
64. The spinal fixation assembly according to claim 51, wherein
said receiver member includes a second slot defined in each of said
opposite first side walls, each said second slot extending from
said channel toward said bottom end of said receiver member.
65. The spinal fixation assembly according to claim 63, wherein
each said second slot intersects said recess.
66. The spinal fixation assembly according to claim 9, wherein said
receiver member includes a second slot defined in each of said
opposite first side walls, each said second slot extending from
said bottom end toward said top end of said receiver member.
67. The spinal fixation assembly according to claim 66, wherein
each said second slot intersects said recess.
68. The spinal fixation assembly according to claim 67, wherein
said second slot terminates between said recess and said top end of
said receiver member.
69. The spinal fixation assembly according to claim 68, wherein id
second slot terminates adjacent said channel.
70. The spinal fixation assembly according to claim 51, wherein
said opposite first side walls are substantially flat and said
opposite second walls are curved.
71. The spinal fixation assembly according to claim 44, in which
the elongated member is a rod having a rod diameter, wherein said
channel has a channel diameter substantially equal to said rod
diameter.
72. The spinal fixation assembly according to claim 71, wherein
said upper opening of said channel has a width that is less than
the rod diameter.
73. The spinal fixation assembly according to claim 71, wherein
said upper opening of said channel has a width that is
approximately equal to said rod diameter.
74. The spinal fixation assembly according to claim 44, wherein
said receiver member further defines a flared opening from said
recess to said bottom end of said member.
75. The spinal fixation assembly according to claim 44, wherein
said receiver member further defines a bore extending from said top
end of said receiver and communicating with said recess, said bore
intersecting said channel and having a bore diameter.
76. The spinal fixation assembly according to claim 75, in which
the elongated member is a rod having a rod diameter, wherein said
channel has a channel diameter substantially equal to the rod
diameter.
77. The spinal fixation assembly according to claim 76, wherein
said bore of said receiver member said bore diameter is greater
than said channel diameter.
78. The spinal fixation assembly according to claim 76, wherein
said bore of said receiver member said bore diameter is
approximately equal to said channel diameter.
79. The spinal fixation assembly according to claim 75, wherein
said receiver member further defines a flared opening from said
recess to said bottom end of said member.
80. The spinal fixation assembly according to claim 79, wherein
said flared opening intersects said recess at a lower diameter
greater than said bore diameter.
81. The spinal fixation assembly according to claim 79, wherein
said flared opening intersects said recess at a lower diameter
substantially equal to said bore diameter.
82. The spinal fixation assembly according to claim 44, wherein a
portion of said upper opening of said channel is angled outwardly
from said channel.
83. The spinal fixation assembly according to claim 44, wherein:
said receiver member defines a groove; and said compression member
is a ring sized to fit within said groove.
84. The spinal fixation assembly according to claim 83, wherein: a
portion of said groove is flat and a remaining portion of said
groove is curved; and said ring includes flat and curved portions
substantially corresponding to said flat and curved portions of
said lower grove.
85. The spinal fixation assembly according to claim 84, wherein
said ring is a closed ring that entire encircles said receiver
member at said groove.
Description
BACKGROUND OF THE INVENTION
[0001] The present invention concerns a bone screw assembly, and
particularly an assembly useful for engagement in the vertebrae of
the spine. The invention contemplates an assembly that is capable
of supporting a bone engaging fastener at multiple angular
orientations with respect to an elongated member extending along
the spine.
[0002] Several techniques and systems have been developed for
correcting and stabilizing the spine and for facilitating fusion at
various levels of the spine. In one type of system, a bendable rod
is disposed longitudinally along the length of the spine or
vertebral column. The rod is preferably bent to correspond to the
normal curvature of the spine in the particular region being
instrumented. For example, the rod can be bent to form a normal
kyphotic curvature for the thoracic region of the spine, or a
lordotic curvature for the lumbar region. In accordance with such a
system, the rod is engaged to various vertebrae along the length of
the spinal column by way of a number of fixation elements. A
variety of fixation elements can be provided which are configured
to engage specific portions of the vertebra. For instance, one such
fixation element is a hook that is configured to engage the laminae
of the vertebra. Another very prevalent fixation element is a
spinal screw which can be threaded into various aspects of the
vertebral bone.
[0003] In one typical procedure utilizing a bendable rod, the rod
is situated on opposite sides of the spine or spinous processes. A
plurality of bone screws are threaded into a portion of several
vertebral bodies, very frequently into the pedicles of these
vertebrae. The rods are affixed to these plurality of bone screws
to apply corrective and stabilizing forces to the spine.
[0004] One example of a rod-type spinal fixation system is the
TSRH.RTM. Spinal System sold by Danek Medical, Inc. The TSRH.RTM.
System includes elongated rods and a variety of hooks, screws and
bolts all configured to create a segmental construct throughout the
spine. In one aspect of the TSRH.RTM. System, the spinal rod is
connected to the various vertebral fixation elements by way of an
eyebolt. In this configuration, the fixation elements are engaged
to the spinal rod laterally adjacent to the rod. In another aspect
of the TSRH.RTM. System, a variable angle screw is engaged to the
spinal rod by way of an eyebolt. The variable angle screw allows
pivoting of the bone screw in a single plane that is parallel to
the plane of the spinal rod. Details of this variable angle screw
can be found in U.S. Pat. No. 5,261,909 to Sutterlin et al., owned
by the Assignee of the present invention. One goal achieved by the
TSRH.RTM. System is that the surgeon can apply vertebral fixation
elements, such as a spinal hook or a bone screw, to the spine in
appropriate anatomic positions. The TSRH.RTM. System also allows
the surgeon to easily engage a bent spinal rod to each of the
fixation elements for final tightening.
[0005] Another rod-type fixation system is the Cotrel-Dubosset/CD
Spinal System sold by Sofamor Danek Group, Inc. Like the TSRH.RTM.
System, the CD.RTM. System provides a variety of fixation elements
for engagement between an elongated rod and the spine. In one
aspect of the CD.RTM. System, the fixation elements themselves
include a body that defines a slot within which the spinal rod is
received. The slot includes a threaded bore into which a threaded
plug is engaged to clamp the rod within the body of the fixation
element. The CD.RTM. System includes hooks and bone screws with
this "open-back" configuration. Details of this technology can be
found in U.S. Pat. No. 5,005,562 to Dr. Cotrel. One benefit of this
feature of the CD.RTM. System is that the fixation element is
positioned directly beneath the elongated rod. This helps reduce
the overall bulkiness of the implant construct and minimizes the
trauma to surrounding tissue.
[0006] On the other hand, these fixation elements of the CD.RTM.
System are capable only of pivoting about the spinal rod to achieve
variable angular positions relative to the rod. While this limited
range of relative angular positioning is acceptable for many spinal
pathologies, many other cases require more creative orientation of
a bone screw, for instance, relative to a spinal rod. Certain
aspects of this problem are addressed by the variable angle screw
of the TSRH.RTM. System, as discussed in the '909 Patent. However,
there is a need for a bone screw that is capable of angular
orientation in multiple planes relative to the spinal rod.
Preferably, the bone screw is capable of various three-dimensional
orientations with respect to the spinal rod. Screws of this type
have been referred to as poly-axial or multi-axial bone screws.
[0007] Others have approached the solution to this problem with
various poly-axial screw designs. For example, in U.S. Pat. No.
5,466,237 to Byrd et al., a bone screw is described which includes
a spherical projection on the top of the bone screw. An externally
threaded receiver member supports the bone screw and a spinal rod
on top of the spherical projection. An outer nut is tightened onto
the receiver member to press the spinal rod against the spherical
projection to accommodate various angular orientations of the bone
screw relative to the rod. While this particular approach utilizes
a minimum of components, the security of the fixation of the bone
screw to the rod is lacking. In other words, the engagement or
fixation between the small spherical projection on the bone screw
and the spinal rod is readily disrupted when the instrnmentation is
subjected to the high loads of the spine, particularly in the
lumbar region.
[0008] The same inventors implemented a somewhat different approach
in U.S. Pat. No. 5,474,555. In this patent, an anchor receives a
smei-spherical head of a bone screw within a recess. The anchor
includes a rod channel transverse to the screw recess. The anchor
is externally threaded to receive an internally threaded nut. In
one embodiment, the nut is threaded directly down onto the spinal
rod to clamp the rod within the channel. In another embodiment, a
cap is provided between the rod and nut. In both embodiments,
neither the rod nor the external not impart any clamping force onto
the head of the bone screw.
[0009] In another approach shown in U.S. Pat. No. 4,946,458 to
Harms et al., a spherical headed bone screw is supported within
separate halves of a receiver member. The bottom of the halves are
held together by a retaining ring. The top of the receiver halves
are compressed about the bone screw by nuts threaded onto a
threaded spinal rod. In another approach taken by Harms et al., in
U.S. Pat. No. 5,207,678, a receiver member is flexibly connected
about a partially spherical head of a bone screw. Conical nuts on
opposite sides of the receiver member are threaded onto a threaded
rod passing through the receiver. As the conical nuts are threaded
toward each other, the receiver member flexibly compresses around
the head of the bone screw to clamp the bone screw in its variable
angular position. One detriment of the systems in the two Harms et
al patents is that the spinal rod must be threaded in order to
accept the compression nuts. It is known that threaded rods can
tend to weaken the rods in the face of severe spinal loads.
Moreover, the design of the bone screws in the '458 and '678
Patents require a multiplicity of parts and are fairly complicated
to achieve complete fixation of the bone screw.
[0010] Two patents to Errico et al., U.S Pat. Nos. 5,549,608 and
5,554,157, depict two alternative approaches to multi-angle bone
screw apparatus. The '608 Patent describes a complicated array of
components that includes a tapered lower portion defining a
spherical recess to receive the head of a bone screw. The lower
portion is slotted so that the lower portion can be compressed
about the bone screw head by operation of a ring pushed down the
tapered lower portion. A hollow cylindrical rod securing sleeve
fits over an upper portion of the coupling element that is operable
to clamp the rod within the coupling element as the sleeve is
pushed down onto the ring. The coupling element includes a threaded
post onto which a nut is threaded that is operable to push the
sleeve down onto the rod and onto the ring to compress the lower
portion against the bone screw head. Like the Harms devices
described above, the approach in the '608 Patent involves a
multiplicity of parts and excessive "fiddle factor" for use in a
spinal surgery.
[0011] The second alternative in the Errico '157 Patent is similar
to the approach taken in the Puno '555 Patent, except that the rod
contacts the spherical head of the bone screw in the '157 Patent.
An external nut is threaded directly down onto the spinal rod which
then bears directly on the bone screw head to clamp the head within
a spherical recess. While this design offers much greater
simplicity than the Errico '608 Patent it suffers from the point
contact between the rod and the spherical head of the bone screw.
It is uncertain whether this clamping mechanism is sufficient to
maintain the relative position between bone screw and spinal rod
under severe spinal loads.
[0012] In recent years, a special material known as "shape-memory
alloy" has found its way into the field of medical devices. These
materials are alloys of known metals, such as copper and zinc,
nickel and titanium, silver and cadmium, and others, that are known
to exhibit a "shape-memory" in which a particular component formed
of a shape-memory alloy (SMA) will change shape upon changes in
temperature.
[0013] The shape-memory characteristics of SMAs occur when the
alloy changes from a martensitic crystal phase to an austenitic
crystal phase. In the martensitic stage, the SMA is relatively weak
and pliable. As the temperature of the SMA component is increased
above a transformation temperature range, the SMA transforms to its
austenitic phase in which the material is relatively strong with
super-elastic properties. Generally, the strength and super-elastic
characteristics of an SMA tend to increase toward the high
temperature end of the transformation temperature range and
decrease toward the low temperature end.
[0014] In use, an object made of an SMA is formed into a particular
shape at a temperature that is either above or below the
transformation temperature range. The object will then change shape
as its temperature increases or decreases through that
transformation temperature range. In the field of medical devices,
a device is formed into its in situ shape at the high temperature,
or the temperature above the transformation temperature range. The
device is then cooled to be provided to the surgeon for
implantation. One known application of SMA technology in the
medical field is a vena cava filter that assumes a smaller shape at
its low temperature, and then expands to its larger shape within a
blood vessel when heated to body temperature.
[0015] While there are many alloys that exhibit shape memory
characteristics, one of the more common SMAs in the medical field
is an alloy of nickel and titanium. One such well known alloy is
Nitinol.RTM., which has proven highly effective for devices placed
within the human body because its transformation temperature range
falls between room temperature and normal human body temperature.
Shape-memory technology has also found its way into the field of
orthodontics, as described in U.S. Pat. No. 5,551,871 to Besselink
et al. This patent describes face bow head gear used for aligning
teeth of a patient in which an SMA wire is used to align and hold
the teeth of a patient. The '871 Patent also discloses devices for
use in treating scoliosis including a transverse connector and bone
engaging fasteners that clamp to an elongated rod by way of
shape-memory characteristics. While the '871 Patent shows one use
of SMA technology for spinal hooks and screws, the hooks and screws
are only capable of pivoting about the axis of the rod. In this
regard, the devices shown in the '871 Patent are similar to the
components of the CD.RTM. System discussed above.
[0016] There is a need remaining in the industry for a multi-axial
or poly-axial bone screw that can be readily and securely engaged
to an elongated spinal rod. Preferably, the spinal rod can be of
any configuration--i.e., smooth, roughened, knurled or even
threaded.
[0017] This need also encompasses the goal of minimizing the
profile and bulk of any of the components used to engage the bone
screw to the spinal rod in a variety of angular orientations.
Moreover, it is desirable to reduce the number of components of the
system that must be manipulated by the surgeon during a surgical
procedure.
DESCRIPTION OF THE FIGURES
[0018] FIG. 1 is a side elevational view of a multi-axial screw
assembly according to one embodiment of the present invention.
[0019] FIG. 2 is a side cross-sectional view of the screw assembly
depicted in FIG. 1.
[0020] FIG. 3 is a side elevational view of the screw assembly
shown in FIG. 1, with a spinal rod engaged within the assembly.
[0021] FIG. 4 is a side elevational view of the assembly as shown
in FIG. 3, with the assembly rotated 90.degree. go to show the rod
extending through the multi-axial screw assembly.
[0022] FIG. 5 is a side elevational view of a bone screw adapted
for use with the multi-axial screw assembly shown in FIG. 1.
[0023] FIG. 6 is a top perspective view of a receiver member used
with the multi-axial screw assembly shown in FIG. 1.
[0024] FIG. 7 is a side elevational view of the receiver member
shown in FIG. 6.
[0025] FIG. 8 is an end elevational view of the receiver member
shown in FIG. 6.
[0026] FIG. 9 is a top elevational view of a locking ring used with
the multi-axial screw assembly shown in FIG. 1.
[0027] FIG. 10 is a top perspective view of the receiver member
depicted in FIG. 10.
[0028] FIG. 11 is a cross sectional view of a receiver member
according to an additional embodiment of the present invention.
[0029] FIG. 12 is a side elevational view of the receiver member
shown in FIG. 11, with a spinal rod and SMA ring depicted in
phantom lines engaged to the receiver member.
[0030] FIG. 13 is an end elevational view of the receiver member
shown in FIG. 10.
SUMMARY OF THE INVENTION
[0031] The deficiencies of prior bone screws are addressed by
several aspects of the present invention. In one embodiment of the
invention, a spinal fixation assembly is provided which includes a
bone engaging fastener, such as a bone screw, and an elongated
member, such as a spinal rod. The fixation assembly includes a
multi-axial screw assembly that permits fixation of the bone screw
to the spinal rod at any of a plurality of angles in
three-dimensional space relative to the rod. In other words, the
bone screw can pivot relative to the rod about a cone directly
beneath the spinal rod. In one aspect of the invention, the bone
screw includes a head that is at least partially spherical. The
head is preferably truncated to form a flat upper surface within
which a tool engaging recess is defined.
[0032] The multi-axial screw assembly further includes a receiver
member defining a bore therethrough from its top end to its bottom
end. The bore further includes a recess for receiving the head of
the bone screw, with a lower opening at the bottom end of the
receiver member through which a lower portion of the bone screw
extends to engage the spine. The receiver member also includes a
channel transverse to the bore and communicating with the bore to
receive the spinal rod. Both the bone screw and the spinal rod can
be inserted into the receiver member through an upper opening.
[0033] In a further aspect of the invention, a locking ring is
provided at the bottom of the receiver member. The locking ring is
configured to closely fit around the perimeter of the receiver
member and particularly overlapping the recess within which the
head of the bone screw resides. In accordance with the invention,
the locking ring is formed of a shape-memory alloy (SMA) configured
so that the locking ring has a first diameter that is larger than a
second diameter, and in which the locking ring transforms from the
first diameter to the second diameter when heated to the body
temperature of the patient. In other words, the locking ring
contracts with increasing temperature so that the ring presses the
receiver member against the head of the bone screw, thereby
clamping the bone screw within the multi-axial screw assembly.
[0034] In a further feature of the invention, the receiver member
includes thin slots on opposite sides of the receiver to facilitate
compression of the receiver member about the head of the bone
screw. In another aspect, opposite slots are provided in the
receiver member that are offset by 90.degree. from the other slots.
These slots extend into the channel within which the spinal rod is
received. A second SMA locking ring is disposed over the top of the
receiver member to apply a clamping force from the top of the
receiver member. In this manner, the spinal rod can be engaged by
the receiver member as the upper SMA locking ring transforms to its
austenitic shape.
[0035] In another embodiment, the receiver member is modified to
permit entry of the bone screw head from the bottom of the receiver
member. In this embodiment, the receiver member is provided with a
plurality of slots emanating from the bottom of the member. The
recess within the member is enlarged adjacent the bottom of the
receiver member to accept the bone screw head by expansion of the
receiver member at the slots. The slots terminate adjacent the rod
channel so that transformation of the lower SMA ring will provide
some clamping force to the spinal rod. In addition, the upper
portion of the receiver member will provide further clamping force
upon temperature transformation of the upper SMA ring.
[0036] The present invention provides an assembly that permits
fixation of a bone engaging fastener to an elongated member at a
plurality of three-dimensional angular orientations relative to the
elongated member. The preferred embodiments of the inventive
multi-axial screw assembly provides the advantage of a solid
fixation between a spinal rod and a bone screw, regardless of the
angle between the two components.
[0037] A further benefit of the present invention resides in the
minimum number of components necessary to effect this solid
fixation. Yet another benefit is achieved by the use of
shape-memory technology to eliminate the need for extra mechanical
fasteners and engagement instruments that are prevalent with prior
devices.
[0038] It is one object of the invention to provide an assembly
that allows for solid fixation of a fastener at a wide range of
three-dimensional angles relative to an elongated component.
Another object is to provide such an assembly that has minimum
prominence and minimum bulk, and that readily supports the bone
engaging fastener directly beneath the elongated member. Other
objects and benefits of the inventions will become apparently upon
consideration of the following written description and accompanying
figures illustrating one embodiment of the invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0039] For the purposes of promoting an understanding of the
principles of the invention, reference will now be made to the
embodiments illustrated in the drawings and specific language will
be used to describe the same. It will nevertheless be understood
that no limitation of the scope of the invention is thereby
intended, such alterations and further modifications in the
illustrated device, and such further applications of the principles
of the invention as illustrated therein being contemplated as would
normally occur to one skilled in the art to which the invention
relates.
[0040] In one aspect of the invention, a spinal fixation assembly
includes an elongated member, such as the spinal rod, and a
multi-axial screw assembly, such as the assembly 10 shown in FIGS.
1 and 2. The spinal fixation assembly can use a multi-axial screw
assembly 10 at one or more locations along the length of the spine.
The spinal fixation assembly can be used in a variety of
applications within the spine to address a wide range of spinal
pathologies. For example, a fixation assembly can be limited to the
lumbar region for fixation following a diskectomy. Alternatively, a
spinal fixation assembly can extend substantially along the entire
length of the spine, such as along the thoracic and lumbar regions,
to correct a deformity, such as scoliosis.
[0041] In other applications, a spinal fixation assembly
implementing the present invention can provide for fixation and
stabilization of the cervical spine, such as might occur following
a fracture or dislocation. It is of course understood by a person
of skill in this art that the components of the spinal fixation
system will vary depending upon the region of the spine, and the
treatment to be administered. In certain applications, a number of
hooks will engage aspects of several vertebrae. In another fixation
assembly, bone screws can be threaded into portions of the
vertebrae, as all operating as an anchor for an elongated member,
such as a spinal rod.
[0042] In accordance with the present invention, engagement between
the elongated member and one or more vertebrae may require
orientation of a fixation member at a wide range of three
dimensional angles relative to the elongated member. In some
circumstances, it is difficult to situate the elongated member,
such as a spinal rod, in an optimum location relative to the
vertebrae. In this instance, engagement of a fixation member to the
spine may require that the fixation member assume various angles
relative to the spinal rod, and certainly angles that may not be
achieved by prior devices and systems.
[0043] Referring now to FIGS. 1 and 2, a multi-axial screw assembly
10 according to one embodiment of the invention is illustrated. The
assembly 10 includes a bone screw 11 that is mounted within a
receiver member 12. In the preferred embodiment, a pair of
shape-memory alloy (SMA) locking rings are provided to clamp the
receiver member 12 about at least the bone screw 11. A use of the
screw assembly 10 as part of a spinal fixation system is depicted
in FIGS. 3 and 4. In this particular spinal fixation system or
assembly, the elongated member is a spinal rod R that extends
through the receiver member 12. As shown specifically in FIG. 3,
the bone screw 11 is capable of assuming a range of angles up to an
angle A relative to the spinal rod. It is understood that the bone
screw can sweep through a cone defined at the angle A, although the
angle is only depicted in the plane of the paper in the figure.
[0044] Details of the bone screw 11 are shown in FIG. 5. In
particular, the bone screw 11 includes a threaded shank 15 that
carries threads configured to engage the bone of a vertebra. In one
specific embodiment, the threads can be cancellous threads that are
configured to engage the vertebral body. The bone screw 11 also
includes a head 16 that is preferably at least partially
spherically shaped. In one specific embodiment, the head 16
includes a flat surface 16a within which is defined a tool
receiving recess 17. The tool receiving recess 17 can be configured
to accept any type of known driving tool. In the specific
embodiment, the tool receiving recess 17 is a hex recess to receive
the hex end of a driving tool. The tool receiving recess 17 allows
for insertion of the bone screw 11 into the vertebra.
[0045] The head 16 of bone screw 11 is preferably substantially
spherically shaped to include a spherical surface 18. The spherical
surface 18 provides for bearing contact with the receiver member 12
so that the bone screw can be arranged at a variety of angular
orientations relative to the receiver member, with and without the
spinal rod R extending therethrough. In a further aspect of the
bone screw 11, an annular relief 19 is provided between the
spherical head 16 and the threaded shank 15. Referring back to
FIGS. 1 and 2, it can be seen that that annular relief 19 allows
the bone screw 11 to have a wider range of movement within the
receiver member 12 and helps avoid contact between the shank of the
bone screw and the bottom of the receiver member.
[0046] Details of the receiver member 12 can be discerned from
FIGS. 6-8. In one specific embodiment, the receiver member 12
defines a spherical recess 26 adjacent the bottom end of the
member. The recess is preferably at least partially spherical, as
shown more clearly in FIG. 2. In the specific embodiment, the
spherical recess 26 has a diameter that is substantially equal to
the diameter of the spherical surface 18 of the head of the bone
screw 11. In addition, in the specific embodiment, the spherical
recess 26 contacts only a portion of the spherical surface 18 of
the bone screw 11. In the illustrated embodiment, this contact
amounts to about one-third of the spherical surface 18.
[0047] Returning to FIGS. 6-8, it can be seen that the receiver
member 12 includes a flared opening 27 at the bottom of the member.
Again looking back to FIG. 2, this flared opening 27 can be seen as
providing for an enhanced range of movement of the bone screw 11 as
the spherical head 16 pivots within the spherical recess 26. In
accordance with the preferred embodiment, the flared opening 27
communicates with the spherical recess 26 at a diameter that is
less than the largest diameter of the spherical head 16 of the bone
screw 11. In this manner, the bone screw 11 will not pass through
the bottom of receiver member 12.
[0048] In one embodiment, the receiver member further defines a
central bore 25 extending from the top of the member to the recess
26. In this specific embodiment, the central bore 25 has a diameter
that is approximately equal to the diameter of the spherical recess
26, or more particularly the diameter of the head 16 of the bone
screw 11. The bone screw can be inserted into the receiver member
12 through an upper opening 28. The screw 11 passes through the
bore 25 so that the head 16 of the bone screw can be pressed into
the spherical recess 26 at the base of bore 25. As also shown in
FIG. 2, the bore 25 can also allow access for a driving tool to
engage the tool receiving recess 17 of the bone screw 11. In this
manner, the bone screw can be threaded into a vertebra with the
screw provisionally retained within the receiver member 12.
[0049] Looking again at FIGS. 6-8, it can be seen that the receiver
member 12 has the general configuration of a cylinder having
truncated side walls. In the preferred embodiment, the receiver
member 12 includes opposite curved side walls 30 separated by
opposing flat side walls 32. The flat side walls 32 define a rod
channel 33 that extends transversely across bore 25 in the receiver
member 12. An angled guide wall 35 can be formed on top of each of
the curved side walls 30 to guide a spinal rod R (FIG. 3) through
the upper opening 28 and into the rod channel 33. In accordance
with a specific embodiment, the rod channel 33 is substantially
circular and has a diameter that is substantially equal to the
outer diameter of the spinal rod R to be disposed within the
channel. The flat side walls 32 also define a linear channel 35
communicating between the rod channel 33 and the upper opening 28.
Preferably, the linear channel 35 defines a width that is slightly
smaller than the diameter of the rod channel 33 and than the
largest diameter of the spinal rod R to be disposed within the rod
channel 33. In this manner, the spinal rod can be at least
provisionally held within the rod channel 33 prior to tightening of
the locking rings 13 about the receiver member 12. In a specific
embodiment, the width of the linear channel 35 is less than the
diameter of the bore 25.
[0050] The preferred embodiment contemplates a receiver member 12
that is split at a pair of opposite upper slots 36 and a pair of
opposite lower slots 37. In one embodiment, the upper slots 36 are
defined from the base of the rod channel 33. The upper slots 36
permit slight contraction of the upper portion of the receiver
member 12 about a spinal rod R disposed within the rod channel 33.
Moreover, the upper slots 36 also permit slight expansion of the
receiver member and particular the bore 25 during insertion of the
bone screw 11 and linear channel 35 during insertion of the rod R
from the upper opening 28.
[0051] In the present embodiment, the lower slots 37 are disposed
at the bottom of the receiver member 12 and intersect the flared
opening 27 and the spherical recess 26, in accordance with the
preferred embodiment. The lower slots 37 allow contraction of the
lower portion of the receiver member 12 about the head 16 of the
bone screw 11. As shown in FIGS. 6-8, the upper slots 36 are offset
by 90.degree. relative to the lower slots 37. More particularly,
the upper slots 36 are defined in the flat side walls 32, while the
lower slots 37 are defined in the curved side walls 30.
[0052] In the preferred embodiment, the receiver member 12 defines
features for supporting the pair of SMA locking rings 13. In one
specific embodiment, an upper engagement groove 39 is defined
within the curved side walls 30 at the top of the receiver member
12. A lower engagement groove 40 is also defined in the curved side
walls 30 at the bottom of the receiver member 12. Preferably, the
upper and lower grooves 39, 40 are configured to closely receive a
corresponding locking ring 13 thereabout. An upper lip 41 is
provided at the upper end of the engagement groove 39 to retain a
locking ring 13 at the top of receiver member 12. Likewise, a lower
lip 42 helps retain a locking ring 13 at the bottom of the receiver
member 12.
[0053] In the specific embodiment of the invention, the lower
engagement groove 40 is situated within the same plane as the
spherical recess 26. In this manner, when the locking ring 13 at
the bottom of the receiver member 12 contracts, the greatest amount
of force will be applied directly from the receiver member 12
through the recess 26 to the spherical head 16 of the bone screw
11. Again in the specific embodiment, the upper engagement groove
39 is situated as close to the top of the receiver member 12 as
possible so that upon contraction of the upper locking ring 13, the
receiver member 12 wraps slightly around the spinal rod R to clamp
the rod within the rod channel 33.
[0054] In one feature of the present invention, each of the locking
rings 13 has a substantially similar configuration. As shown in
FIG. 9, the locking rings 13 are substantially rectangular with
curved end walls to substantially conform to the truncated
cylindrical configuration of the receiver member 12. In other
words, each of the locking rings 13 includes opposite curved walls
45 separated by opposite flat walls 46. Preferably, the locking
rings 13 define an opening 47 between the walls 45, 46 that
conforms to the upper engagement groove 39 and lower engagement
groove 40. Also preferably, the ring 13 has an effective diameter
between the curved walls 45 that is substantially equal to the
diameter of the engagement grooves 39, 40 when the SMA locking ring
13 is in its martensitic or room temperature state.
[0055] When the locking ring 13, and particularly the screw
assembly 10, is placed within the patient, the body temperature of
the patient will increase the temperature of the locking rings 13.
As the temperature increases past the transformation temperature
range, the locking rings 13 move from their martensitic to their
austenitic phases. In the austenitic phase at the higher
temperature, the locking rings 13 deform to a smaller size, as
reflected by the curved walls 45' and flat walls 46'. The locking
13 in the upper groove 39 can be formed so that only the flat walls
46 shorten, while locking ring for the lower groove 40 can be
formed so that only the curved walls 45 shorten. In this manner,
the curved walls 45 of the upper locking ring can press the curved
side walls 30 of the receiver member 12 toward each other and about
the spinal rod R as the flat walls shorten. Likewise, the
shortening of the curved walls 46 of the lower locking ring can
cause the side walls 46 of the ring to press the side walls 32 of
the receiver member 12 together about the screw head.
[0056] In accordance with the present invention, the multi-axial
screw assembly 10 is initially provided with the spherical head 16
of the bone screw 11 disposed within the spherical recess 26 of the
receiver member 12. In addition, a locking ring 13 is situated
within the lower engagement groove 40 to loosely retain the bone
screw within the receiver member. This initially assembled
arrangement can be introduced to the surgical site and the bone
screw 11 threaded into the vertebra according to the protocol for
the particular spinal procedure. As indicated above, a driving tool
can pass through the bore 25 of the receiver member 12, with the
bore being substantially aligned with the tool receiving recess 17
in the head of the bone screw. Preferably, the bone screw 11 is
driven into the vertebra to a recommended depth for adequate
fixation, but preferably not so deep that the bottom of the
receiver member 12 will contact or press against the vertebral
bone. In order for the multi-axial capability of the assembly 10 to
be realized, the receiver member 12 must be free to pivot in three
dimensions about the head 16 of the bone screw 11.
[0057] Once the bone screw has been adequately fixed within the
vertebra, the spinal rod R can be introduced into the rod channel
33, as shown in FIG. 3. It should be noted that the receiver member
12 is configured so that the spinal rod R does not contact the bone
screw 11, regardless of the relative angle between the rod,
receiver member 12 and bone screw head 16. Instead, the rod R is
supported in the rod channel 33 by the flat side walls 32. With the
rod properly positioned, the second locking ring 13 can be disposed
on the receiver member 12, and particularly in the upper engagement
groove 39.
[0058] It is understood that the locking rings 13 are at least
initially at or below room temperature. Once the first locking ring
13 is situated within the patient upon insertion of the bone screw
11, the temperature of the locking ring 13 and the lower engagement
groove 40 will increase. Once that temperature increases beyond the
transformation temperature range of the SMA, the locking ring 13
will contract to the shape shown in FIG. 9 as indicated by curved
walls 45' and flat walls 46'. At this point, the spherical head 16
of the bone screw 11 will be firmly clamped within the spherical
recess 26 of the receiver member 12.
[0059] Substantially concurrently, the locking ring 13 in the upper
engagement groove 39 will also contract as its temperature
increases above the transformation temperature range. At that
point, then, the receiver member 12 will be contracted about the
spinal rod R to firmly clamp the spinal rod within the rod channel
33. Once both SMA locking rings 13 have moved to their austenitic
phase, the multi-axial screw assembly 10 is firmly clamped and the
bone screw 11 is solidly fixed to the spinal rod R. It can be seen
that the present invention provides a screw assembly 10 that offers
a low profile and minimum prominence. In particular, the bone screw
is attached to the spinal rod directly beneath the rod, or in line
between the rod and the vertebra. The overall bulk or prominence of
the present invention is minimized by the use of the SMA locking
rings 13, which is in contrast to the prior devices which require
some form of external cap or nut threaded onto the top of a
receiver member.
[0060] The present invention provides a screw assembly that can be
tightened from the top, meaning that the bone screw 11 can be
threaded onto the vertebra from the top. In addition, the spinal
rod is loaded from the top, which can greatly simplify a spinal
surgical procedure. In accordance with one feature of the
invention, the rod does not need to be preloaded into the receiver
member 12. Moreover, the multi-axial capability allows a bone screw
to be connected with a spinal rod with minimal contouring of the
rod being necessary.
[0061] In one specific embodiment of the invention, the bone screw
11 is configured for engagement in the lumbar spine and has an
overall length of about 2.126 inches. The spherical head 16 and
particularly the spherical surface 18 of the bone screw has an
outer diameter of about 0.315 inches, while the annular relief 19
has a diameter of about 0.236 inches.
[0062] Further in accordance with a specific embodiment, the
receiver member 12 has an overall height of about 0.609 inches. The
receiver member defines a bore 25 having a diameter of about 0.295
inches, which is slightly smaller than the outer diameter of the
spherical head 16 of the bone screw 11. On the other band, the
spherical recess 26 has a diameter of approximately 0.315 inches to
correspond to the outer diameter of the head of the bone screw 11.
The flared opening 27 of the receiver member 12 increases to an
opening diameter of 0.400 inches, in the specific embodiment. Also
in the specific embodiment, the receiver member 12 has a width
between the flat side walls 32 of 0.354 inches. This corresponds to
the room temperature distance between the flat walls 46 of the
locking rings 13. Similarly, the receiver member 12 has a maximum
dimension between the curved side walls 30 of 0.462 inches at the
upper and lower engagement grooves 39, 40. This dimension is
substantially the same as the maximum distance between the curved
walls 45 of the locking rings 13 in their room temperature
configuration.
[0063] In the preferred embodiment, the upper slots 36 and lower
slots 37 have a width of about 0.020 inches, which means that the
receiver member 12 can contract over that distance at the
respective slots. Thus, in order for the receiver member 12 to
contract at the slots 36, 37 extent, the flat walls 46 of the
locking rings 13 must shrink by about 0.020 inches. This change in
length amounts to about a 4% reduction in the overall length of
each of the flat walls 46. This percentage reduction is typical for
many medical grade-SMAs; however, other SMAs could be used having
different transformation capabilities. In the specific embodiment,
the locking rings 13 are formed of Nitinol.RTM..
[0064] In an alternative embodiment of the invention, a modified
receiver member 52 is provided as shown in FIGS. 10-13. In this
embodiment, the receiver member 52 includes a bore 55 extending
through a small portion of the center of the receiver member. The
bore opens into a spherical recess 56 that is configured so that
the recess has a maximum diameter that is larger than the maximum
diameter of the bore 55. In one specific embodiment, the recess has
a diameter of about 0.320 in. to accomodate a similarly sized bone
screw head, while the bore 55 has a diameter of about 0.250 in.
[0065] The recess 56 is only partially spherical, meaning that it
does not extend entirely around the spherical head of a bone screw
disposed within the recess. The recess 56 opens to the bottom of
the receiver member at a flared opening 57. In the present
embodiment, the recess contacts about half of the surface area of
the bone screw, with the greater amount of contact at the upper
hemisphere of the recess. In one specific embodiment, the recess 56
intersects the bore 55 at the bore's diameter of 0.250 in. At the
lower end of the recess, the recess 56 intersects the flared
opening 57 at a diameter that is greater than the diameter of the
bore, namely about 0.305 in.
[0066] An upper opening 58 is provided at the top end of the
receiver member, in one specific embodiment, preferably to permit
insertion of the spinal rod. In this alternative embodiment, the
bone screw, which can be the bone screw 11 described above, is
loaded into the receiver member 52 from the bottom of the member.
Thus, the upper opening 58 need not be provided for insertion of
the bone screw, as in the embodiment of FIGS. 1-9. Likewise, the
bore 55 may be eliminated unless it is needed for access by a screw
insertion tool.
[0067] In accordance with this alternative embodiment, the receiver
member 52 includes curved side walls 60 and flat side walls 62
similar to the receiver member 12. Likewise, the member 52 includes
a rod channel 63 defined in the side walls that intersects a
portion of the bore 55. The rod channel 63 opens to a linear
channel 65 that incorporates angled guide walls 64 at the top end
of the receiver member. In this embodiment, the linear channel 65
has a width that is substantially equal to the diameter of the bore
55 and rod channel 63.
[0068] As in the previous embodiment, the receiver member 52 is
adapted to receive SMA locking rings at the top and bottom of the
member. Thus, the receiver member 52 includes upper and lower
engagement grooves 69, 70 defined by upper and lower lips 71, 72.
An SMA locking ring 13 fits into each of the grooves 69, 70 and
operates in the thermally responsive manner described above to
contract about the receiver member.
[0069] In a further modification from the prior embodiment, the
receiver member 52 includes short slots 66 defined in the flat side
walls 62, and long slots extending from the bottom of the receiver
in the curved side walls 60. In accordance with the present
embodiment, the one short slot is provided in each flat side wall
62 that emanates from the bottom of the receiver member and that
terminates generally in the middle of the spherical recess 56. On
the other hand, the three long slots are provided in the curved
side walls 60. The long slots extend from the bottom of the
receiver member and terminate adjacent the level of the bottom of
the rod channel 63.
[0070] The receiver member 52 of the embodiment in FIGS. 10-13
permits bottom loading of the bone screw by brief expansion of the
spherical recess 56 and flared opening 57 at the slots 66 and 67.
The lower SMA locking ring 13 can be added once the bone screw head
is situated within the recess 56 by slightly compressing the
receiver member at the slots 66, 67. Contraction of the lower SMA
locking ring 13 due to temperature change again operates to
compress the receiver member at the lower engagement groove 70 by
closing the slots. In one specific embodiment, only the short slots
66 in the flat side walls 62 will close to clamp the bone screw
head within the spherical recess 56. In another embodiment, the
long slots 67 will also collapse upon a size reduction of the SMA
locking ring.
[0071] Fixation of a spinal rod within the receiver member of this
embodiment can be accomplished in many ways. First, referring to
FIG. 12, it can be seen that an SMA locking ring 13' disposed in
the upper engagement groove 69 will directly abut the rod R'
disposed within the rod channel 63. In this respect, the upper
groove 69 and locking ring 13' is situated closer to the rod
channel 63, and consequently the spinal rod R', than with the
previous embodiment. Fixation of the rod R' within the rod channel
63 can also be effected by compression of the upper portion of the
receiver member, and particularly the upper portion of the curved
side walls 60, by SMA contraction of the upper locking ring 13'.
Finally, additional compression of the receiver member 52 can be
accomplished by contraction of the SMA locking ring in the lower
engagement groove which contract the slots 66 and 67.
[0072] While the invention has been illustrated and described in
detail in the drawings and foregoing description, the same is to be
considered as illustrative and not restrictive in character, it
being understood that only the preferred embodiments have been
shown and described and that all changes and modifications that
come within the spirit of the invention are desired to be
protected.
[0073] For example, while the preferred embodiment contemplates a
bone screw, such as screw 11, other bone engaging fasteners are
contemplated. The multi-axial capabilities can be equally
applicable to a vertebral hook, for example. Further, the
components of the multi-axial screw assembly 10 can be sized
according to the portion of the spine within which the assembly is
to be used. In the illustrated embodiment, the components are
dimensioned for use in the lumbar spine. It is understood that
smaller components would be required in the thoracic and cervical
spine, while the multi-axial movement capabilities can be equally
well suited throughout the entire length of the spine. Further,
while the invention is described for engagement to an elongated
cylindrical rod, other elongated members are contemplated.
* * * * *