Note: Descriptions are shown in the official language in which they were submitted.
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SP1NE DISTRACTION IMPLANT
Background of the Invention:
As the present society ages, it is anticipated that there will be
an increase in adverse spinal conditions which are characteristic of
older people. By way of example, with aging comes increases in spinal
stenosis (including but not limited to central canal and lateral stenosis),
the thickening of the bones which make up the spinal column and
facet arthropathy. Spinal stenosis is characterized by a reduction in
the available space for the passage of blood vessels and nerves. Pain
associated with such stenosis can be relieved by medication and/or
surgery. Of course, it is desirable to eliminate the need for major
surgery for all individuals and in particular for the elderly.
Accordingly, there needs to be developed procedures and
implants for alleviating such condition which are minimally invasive,
can be tolerated by the elderly and can be performed preferably on an
outpatient basis.
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Summary of the Invention:
The present invention is directed to providing a minimally
invasive implant and method for alleviating discomfort associated with
the spinal column.
The present invention provides for apparatus and method for
reiieving pain by relieving the pressure and restrictions on the
aforementioned blood vessels and nerves. Such alleviation of pressure
is accomplished in the present invention through the use of an implant
and method which distract the spinous process of adjacent vertebra in
order to alleviate the problems caused by spinal stenosis and facet
arthropathy and the like. While the implant and method particularly
address the needs of the elderly, the invention can be used with
individuals of all ages and sizes where distraction of the spinous
process would be beneficial.
In one aspect of the invention, an implant is provided for
relieving pain comprising a device positioned between a first spinous
process and a second spinous process. The device includes a spinal
column extension stop and a spinal column flexion non-inhibitor.
In another aspect of the invention, the implant is positioned
between the first spinous process and the second spinous process and
includes a distraction wedge that can distract the first and second
spinous processes as the implant is positioned between the spinous
processes.
In yet another aspect of the present invention, the implant
includes a device which is adapted to increasing the volume of the
spinal canal and/or the neural foramen as the device is positioned
between adjacent spinous processes.
In yet a further aspect of the present invention, a method is
presented for relieving pain due to the development of, by way of
example only, spinal stenosis and facet arthropathy. The method is
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comprised of the steps of accessing adjacent first and second spinal
processes of the spinal column and distracting the processes a
sufficient amount in order to increase the volume of the spinal canal
in order to relieve pain. The method further includes implanting a
device in order to maintain the amount of distraction required to relieve
such pain.
In yet a further aspect of the invention, the method includes
implanting a device in order to achieve the desired distraction and to
maintain that distraction.
in yet a further aspect of the invention, the implant includes a
first portion and a second portion. The portions are urged together in
order to achieve the desired distraction.
In still a further aspect of the invention, the implant includes a
distracting unit and a retaining unit. The distracting unit includes a
body which can be urged between adjacent spinous processes. The
body includes a slot. After the distracting unit is positioned, the
retaining unit can fit into the slot of the retaining unit and be secured
thereto.
In yet a further aspect of the invention, the implant includes a
first unit with a central body. A sleeve is provided over the central
body and is at least partially spaced from the central body in order to
allow for deflection toward the central body.
In a further aspect of the invention, the implant includes a first
unit having a central body with a guide and a first wing, with the first
wing located at first end of the body. The guide extends from a
second end of the body located distally from the first wing. The
implant further includes a sleeve provided over said central body. The
sleeve is at least partially spaced from the central body in order to
allow for deflection of the sleeve toward the central body. The implant
further includes a second wing and a device for securing the second
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wing to the first unit, wherein the sleeve is located between the first
and second wings.
In yet another aspect of the invention, an implant system
includes a cylindrical sleeve which is inwardly deflectable. The system
further includes an insertion tool which includes an insertion guide, a
central body, a stop and a handle. The guide and the stop extend
from opposite sides of the central body and the handle extend from the
stop. A sleeve fits over the guide and against the stop preparatory to
being positioned between the two adjacent vertebrae with the insertion
tool.
In yet a further aspect of the invention, the impiant includes
central body and first and second wings and a means for selectively
positioning one of the first and second wings relative to the other in
order to accommodate spinous processes of different sizes.
In yet still a further aspect of the invention, the implant includes
a sleeve which is rotatable relative to the wings of the implant in order
to be able to accommodate the anatomical structure of spinous
processes.
In yet still a further aspect of the invention, the sleeve is formed
from bar stock comprised of a super-elastic material.
Other implants and methods within the spirit and scope of the
invention can be used to increase the volume of the spinal canal
thereby alleviating restrictions on vessels and nerves associated
therewith, and pain.
Brief Description of the Figures
Figs. 1 and 2 depict an embodiment of an implant of the
invention which is adjustable in order to select the amount of
distraction required. Fig. 1 depicts the implant in a more extended
configuration than does Fig. 2.
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Figs. 3a and 3b depict side and end views of a first forked and
of the embodiment of Fig. 1.
Figs. 4a and 4b depict side sectioned and end views of an
interbody piece of the implant of Fig. 1.
Figs. 5a and 5b depict side and end views of a second forked
end of the embodiment of Fig. 1.
Figs. 6, 7, 8, 9 and 10 depict apparatus and method for another
embodiment of the present invention for creating distraction between
adjacent spinous processes.
Figs. 11, 12 and 13 depict yet a further embodiment of the
invention for creating distraction between adjacent spinous processes.
Figs. 14 and 15 depict a further apparatus and method of an
embodiment of the invention for creating distraction.
Figs. 16, 16a, and 17 depict yet another embodiment of the
present invention.
Figs. 18, 19 and 20 depict yet a further apparatus and method
of the present embodiment.
Figs. 21 and 22 depict still a further embodiment of the present
invention.
Figs. 23, 24 and 25 depict another embodiment of the present
invention.
Figs. 26, 27 and 28 depict another embodiment of the
invention.
Figs. 29 and 30 depict side elevational views of differently
shaped implants of embodiments of the present invention.
Figs. 31, 32 and 33 depict various implant positions of an
apparatus of the present invention.
Figs. 34 and 35 depict yet another apparatus and method of the
present invention.
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Figs. 36,'37 and 38 depict three different embodiments of the
present invention.
Figs. 39 and 40 depict yet another apparatus and method of an
embodiment of the present invention.
Figs. 41, 42 and 43 depict yet further embodiments of an
apparatus and method of the present invention.
Fig. 44 is still a further embodiment of an implant of the
invention.
Fig. 45 is yet another depiction of an apparatus and method of
the invention.
Figs. 46 and 47 depict still a further apparatus and method of
an embodiment of the invention.
Figs. 48, 49, 50 and 51 depict yet a further apparatus and
method of the invention.
Figs. 52, 53, 54, 55a and 55b depict another apparatus and
method of the invention.
Figs. 56, 57 and 58 depict yet a further apparatus and method
of the invention.
Figs. 59 and 60 depict still a further embodiment of the
invention.
Fig. 61 depict another embodiment of the invention.
Figs. 62 and 63 depict yet another embodiment of the present
invention.
Figs. 64 and 65 depict still a further embodiment of the present
invention.
Fig. 66 depicts another embodiment of the invention.
Figs. 67 and 68 depict yet another embodiment of the present
invention.
Figs. 69, 70, 71 and 71a depict a further embodiment of the
present invention.
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Figs. 72 and 73 depict still another embodiment of the
invention.
Figs. 74, 75, 76, 77, and 78 depict still other embodiments of
the invention.
Figs. 79, 80, 80a, 81, 82, 83, 83a, 84, 85, 86 and 87 depict
still a further embodiment of the present invention.
Figs. 88, 89, 90 and 91 depict yet another embodiment of the
present invention.
Figs. 92, 92a, 92b, 93, 93a, 93b, 93c, 93d, 94, 94a, 94b, 95,
95a, and 96, depict still a further embodiment of the present invention
wherein a sleeve is provided which is capable of deflecting response
to relative motion between the spinous processes.
Fig. 97 depicts still another embodiment of the present
invention.
Fig. 98 depicts yet a further embodiment of the present
invention.
Figs. 99 and 100 depict still another embodiment of the present
invention including an insertion tool.
Figs. 101, 102, 102a, 103, 104, 105, 106, and 107 depict still
a further embodiment of the present invention.
Figs. 108, 109, and 110 depict still another embodiment of the
present invention.
Figs. 111, 112, 113, 114, 115, 116, and 117 depict yet
another embodiment of the present invention.
Fig. 118 depicts a graph showing characteristics of a preferred
material usable with several of the embodiments of the present
invention.
Figs. 11 9a and 11 9b depict side and plan views of still a further
embodiment of the present invention.
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Figs. 120a and 120b depict side and plan views of the second
wing which can be used in conjunction with the embodiment of the
invention of Figs. 119a and 119b.
Figs. 121 a and 121 b depict side and plan views of the first wing
and central body of the embodiment of the invention depicted in Figs.
119a and 119b.
Figs. 122a, 122b, and 122c depict top, side and end views of
a guide which is a portion of the embodiment of the invention of Figs.
119a and 119b.
Figs. 123a and 123b depict an end view and a cross-sectioned
view respectfully of the sleeve of the embodiment of the invention of
Figs. 119a and 119b.
Figs. 124a, 124b and 124c depict a view of the embodiment of
the invention of Figs. 11 9a and 1 19b taken through line 124-124 in
Fig. 11 9b shown in with the sleeve in various positions relative to a
first wing.
Fig. 125 depicts an alternative embodiment of the invention as
depicted in Figs. 119a and 119b.
Fig. 126 depicts yet a further alternative embodiment of the
invention depicted in Figs. 119a and 119b.
Fig. 127 depicts yet a further embodiment of the invention as
depicted in Figs. 119a and 119b.
Fig. 128 is still a further embodiment of the invention as
depicted in Fig. 93a.
Fig. 129 depicts still a further embodiment of the invention as
depicted in Figs. 119a and 119b.
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Detailed Description of the Preferred Embodiment
Embodiment of Figs. 1-5a, 5b
A first embodiment of the invention is shown in Figs. 1-5a, 5b.
Implant 20 includes first and second forked ends 22 and 24, each
defining a saddle 26, 28 respectively. The forked ends 22, 24 are
mated using an interbody piece 30. As can be seen in Figs. 3a, 3b,
the first forked end 22 includes a threaded shaft 32 which projects
rearwardly from the saddle 26. The threaded shaft 32 fits into the
threaded bore 34 (Fig. 4a) of the interbody piece 30.
The second forked end 24 (Figs. 5a, 5b) includes a smooth
cylindrical shaft 36 which can fit into the smooth bore 38 of the
interbody piece 30.
Fig. 1 shows the implant 20 in a fully extended position, while
Fig. 2 shows the implant in an unextended position. In the unextended
position, it can be seen that the threaded shaft 32 of the first forked
end 22 fits inside the hollow cylindrical shaft 36 of the second forked
end 24.
For purposes of implantation between adjacent first and second
spinous processes of the spinal column, the implant 20 is configured
as shown in Fig. 2. The first and second spinous processes are
exposed using appropriate surgical techniques and thereafter, the
implant 20 is positioned so that saddle 26 engages the first spinous
process, and saddle 28 engages the second spinous process. At this
point, the interbody piece 30 can be rotated by placing an appropriate
tool or pin into the cross holes 40 and upon rotation, the saddle 26
is moved relative to the saddle 28. Such rotation spreads apart or
distracts the spinous processes with the resultant and beneficial effect
of enlarging the volume of the spinal canal in order to alleviate any
restrictions on blood vessels and nerves.
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It is noted that this implant as well as the several other implants
described herein act as an extension stop. That means that as the
back is bent backwardly and thereby placed in extension the spacing
between adjacent spinous processes cannot be reduced to a distance
less than the distance between the lowest point of saddle 26 and the
lowest point of saddle 28. This implant, however, does not inhibit or
in any way limit the flexion of the spinal column, wherein the spinal
column is bent forward.
Preferably, such a device provides for distraction in the range of
about 5 mm to about 15 mm. However, devices which can distract up
to and above 22 mm may be used depending on the characteristics of
the individual patient.
With all the ligaments (such as the superspinous ligament) and
tissues associated with the spinous processes left intact, the implant
20 can be implanted essentially floating in position in order to gain the
benefits of the aforementioned extension stop and flexion non-
inhibitor. If desired, one of the saddles 26 can be laterally pinned with
pin 29 to one of the spinous processes and the other saddle can be
loosely associated with the other spinous processes by using a tether
31 which either pierces or surrounds the other spinous process and
then is attached to the saddle in order to position the saddle relative
to the spinous process. Alternatively, both saddles can be loosely
tethered to the adjacent spinous process in order to allow the saddles
to move relative to the spinous processes.
The shape of the saddles, being concave, gives the advantage
of distributing the forces between the saddle and the respective
spinous process. This ensures that the bone is not resorbed due to the
placement of the implant 20 and that the structural integrity of the
bone is maintained.
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The implant 20 in this embodiment can be made of a number of
materials, including but not limited to, stainless steel, titanium,
ceramics, plastics, elastics, composite materials or any combination of
the above. In addition, the modulus of elasticity of the implant can be
matched to that of bone, so that the implant 20 is not too rigid. The
flexibiiity of the implant can further be enhanced by providing
additional apertures or perforations throughout the implant in addition
to the holes 40 which also have the above stated purpose of allowing
the interbody piece 30 to be rotated in order to expand the distance
between the saddles 26, 28.
In the present embodiment, it is understood that the spinous
processes can be accessed and distracted initially using appropriate
instrumentation, and that the implant 20 can be inserted and adjusted
in order to maintain and achieve the desired distraction. Alternatively,
the spinous process can be accessed and the implant 20 appropriately
positioned. Once positioned, the length of the implant can be adjusted
in order to distract the spinous processes or extend the distraction of
already distracted spinous processes. Thus, the implant can be used
to create a distraction or to maintain a distraction which has already
been created.
The placement of implants such as implant 20 relative to the
spinous process will be discussed hereinbelow with other
embodiments. However, it is to be noted that ideally, the implant 20
would be placed close to the instantaneous axis of rotation of the
spinal column so that the forces placed on the implant 20 and the
forces that the- implant 20 places on the spinal column are minimized.
Further, it is noted that during the actual process of installing or
implanting the implant 20, that 'the method uses the approach of
extending the length of the implant 20 a first amount and then
allowing the spine to creep or adjust to this distraction. Thereafter,
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implant 20 would be lengthened another amount, followed by a period
where the spine is allowed to creep or adjust to this new level of
distraction. This process could be repeated until the desired amount
of distraction has been accompiished. This same method can be used
with insertion tools prior to the installation of an implant. The tools
can be used to obtain the desired distraction using a series of spinal
distraction and spine creep periods before an implant is installed.
Embodiment of Figs. 6. 7, 8. 9 and 10
The embodiment of the invention shown in the above Figs. 6,
7, 8, 9 and 10 includes distraction or spreader tool 50 which has first
and second arms 52, 54. Arms 52, 54 are pivotal about pivot point
56 and releaseable from pivot point 56 in order to effect the
implantation of implant 58. As can be seen in Fig. 6, in cross-section,
the arms 52, 54 are somewhat concave in order to cradle and securely
hold the first spinous process 60 relative to arm 52 and the second
spinous process 62 relative to arm 54. The distraction tool 50 can be
inserted through a small incision in the back of the patient in order to
address the space between the first spinous process 60 and the
second spinous process 62. Once the tool 50 is appropriately
positioned, the arms 52, 54 can be spread apart in order to distract
the spinous processes. After this has occurred, an implant 58 as
shown in Figs. 8 and 9, or of a design shown in other of the
embodiments of this invention, can be urged between the arms 52, 54
and into position between the spinous processes. After this occurs,
the arms 52, 54 can be withdrawn from the spinous processes leaving
the implant 58 in place. The implant 58 is urged into place using a
tool 64 which can be secured to the implant 58 through a threaded
bore 66 in the back of the implant. As can be seen in Fig. 10, the
implant 58 includes saddles 89' and 70 which cradle the upper and
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lower spinous processes 60, 62 in much the same manner as the
above first embodiment and also in much the same manner as the
individual arms of the tool 50. The saddles as described above tend
to distribute the load between the implant and the spinous processes
and also assure that the spinous process is stably seated at the lowest
point of the respective saddles.
Embodiment of Figs. 11, 12 and 13
Another embodiment of the apparatus and method of the
invention is shown in Figs. 11, 12 and 13. In this embodiment, the
spreader or distraction tool 80 includes first and second arms 82, 84
which are permanently pivoted at pivot point 86. The arms inciude L-
shaped ends 88, 90. Through a small incision, the L-shaped ends 88,
90 can be inserted between the first and second spinous processes
92, 94. Once positioned, the arms 82, 84 can be spread apart in
order to distract the spinous processes. The implant 96 can then be
urged between the spinous processes in order to maintain the
distraction. It is noted that implant 96 includes wedged surfaces or
ramps 98, 100. As the implant 96 is being urged between the spinous
processes, the ramps further cause the spinous processes to be
distracted. Once the implant 96 is fully implanted, the full distraction
is maintained by the planar surfaces 99, 101 located rearwardly of the
ramps. It is to be understood that the cross-section of the implant 96
can be similar to that shown for implant 58 or similar to other implants
in order to gain the advantages of load distribution and stability.
Embodiments of Figs. 14, 15, 16, 16a, and 17
In Figs. 14 and 15, yet another embodiment of the invention is
depicted. In this embodiment, the implant 110 includes first and
second conically shaped members 112, 114. Member 112 includes a
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male snap connector 116 and member 114 includes a female snap
connector 118. With male snap connector 116 urged into female snap
connector 118, the first member 112 is locked to the second member
114. In this embodiment, a distraction or spreader tool 80 could be
used. Once the spinous process has been spread apart, an
implantation tool 120 can be used to position and snap together the
implant 110. The first member 112 of implant 110 is mounted on one
arm and second member 114 is mounted on the other arm of tool 120.
The member 112, 114 are placed on opposite sides of the space
between adjacent spinous processes. The members 112, 114 are
urged together so that the implant 110 is locked in place between the
spinous processes as shown in Fig. 15. It is to be noted that the
implant 110 can also be made more self-distracting by causing the
cyiindrical surface 122 to be more conical, much as surface 124 is
conical, in order to hold implant 110 in place relative to the spinous
processes and also to create additional distraction.
An alternative embodiment of the implant can be seen in Figs.
16 and 17. This implant 130 includes first and second members 132,
134. In this particular embodiment, the implants are held together
using a screw (not shown) which is inserted through countersunk bore
136 and engages a threaded bore 138 of the second member 134.
Surfaces 139 are flattened (Fig. 17) in order to carry and spread the
load applied thereto by the spinous processes.
The embodiment of implant 130 is not circular in overall outside
appearance, as is the embodiment 110 of Figs. 14 and 15. In
particular, with respect to the embodiment of implant 130 of Figs. 16
and 17, this embodiment is truncated so that the lateral side 140, 142
are flattened with the upper and lower sides 144, 146 being elongated
in order to capture and create a saddle for the upper and lower spinous
processes. The upper and lower sides, 144, 146 are rounded to
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provide a more anatomical implant which is compatible with the
spinous processes.
If it is desired, and in order to assure that the first member 132
and the second member 134 are aligned, key 148 and keyway 150 are
designed to mate in a particular manner. Key 148 includes at least
one flattened surface, such as flattened surface 152, which mates to
an appropriately flattened surface 154 of the keyway 150. In this
manner, the first member is appropriately mated to the second member
in order to form appropriate upper and lower saddles holding the
implant 130 relative to the upper and lower spinous processes.
Fig. 16a depicts second member 134 in combination with a
rounded nose lead-in plug 135. Lead-in plug 135 includes a bore 137
which can fit snugly over key 148. In this configuration, the lead-in
plug 135 can be used to assist in the placement of the second member
134 between spinous processes. Once the second member 134 is
appropriately positioned, the lead-in plug 135 can be removed. It is to
be understood that the lead-in plug 135 can have other shapes such
as pyramids and cones to assist in urging apart the spinous processes
and soft tissues in order to position the second member 134.
Embodiment of Figs. 18, 19 and 20
The implant 330 as shown in Fig. 18 is comprised of first and
second mating wedges 332 and 334. in order to implant these
wedges 332, 334, the spinous processes are accessed from both sides
and then a tool is used to push the wedges towards each other. As
the wedges are urged towards each other, the wedges move relative
to each other so that the combined dimension of the implant 330
located between the upper and lower spinous processes 336, 338
(Fig. 20), increases, thereby distracting the spinous processes. It is
noted that the wedges 332, 334 include saddle 340, 342, which
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receiving the spinous processes 336, 338. These saddles have the
advantages as described hereinabove.
The first or second wedges 332, 334 have a mating
arrangement which includes a channel 344 and a projection of 346
which can be urged into the channel in order to lock the wedges 332,
334 together. The channel 334 is undercut in order to keep the
projection from separating therefrom . Further, as in other devices
described herein, a detent can be located in one of the channel and the
projection, with a complimentary recess in the other of the channel
and the projection. - Once these two snap together, the wedges are
prevented from sliding relative to the other in the channel 344.
While the above embodiment was described with. respect to
wedges, the wedges could also have been designed substantially as
cones with all the same features and advantages.
Embodiments of Figs. 21 and 22
The implant 370 is comprised of first and second distraction
cone 372, 374. These cones are made of a flexible material. The
cones are positioned on either side of the spinous processes 376, 378
' as shown in Fig. 21. Using appropriate tool as shown hereinabove,
the distraction cones 372, 374 are urged together. As they are urged
together, the cones distract the spinous processes as shown in Fig.
22. Once this has occurred, an appropriate screw or other type of
fastening mechanism (not shown) can be used to maintain the position of the
distraction cones 372, 374. The advantage of this arrangement is that
the implant 370 is self-distracting and also that the implant, being
flexible, molds about the spinous processes as shown in Fig. 22.
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Embodiments of Fig. 23, 24 and 25
In Figs. 23 and 24, another embodiment of the implant 170 is
depicted. This implant is guided in place using an L-shaped guide 172
which can have a concave cross-section such as the cross-section 52
of retraction tool 50 in Fig. 6 in order to cradle and guide the implant
170 in position. Preferably a small incision would be made into the
back of the patient and the L-shaped guide tool 172 inserted between
the adjacent spinous processes. The implant 170 would be mounted
on the end of insertion tool 174 and urged into position between the
spinous processes. The act of urging the implant into position could
cause the spinous processes to be further distracted if that is required.
Prior to the insertion of the L-shaped guide tool 172, a distraction tool
such as shown in Fig. 13 could be used to initially distract the spinous
processes.
Implant 170 can be made of a deformable material so that it can
be urged into place and so that it can somewhat conform to the shape
of the upper and lower spinous processes. This deformable material
would be preferably an elastic material. The advantage of such a
material would be that the load forces between the implant and the
spinous processes would be distributed over a much broader surface
area. Further, the implant would mold itself to an irregular spinous
process shape in order to locate the implant relative to spinous
processes.
With respect to Fig. 25, this implant 176 can be inserted over
a guide wire, guide tool or stylet 178. Initially, the guide wire 178 is
positioned through a small incision to the back of the patient to a
position between the adjacent spinous processes. After this has
occurred, the implant is threaded over the guide wire 178 and urged
into position between the spinous processes. This urging can further
distract the spinous processes if further distraction is required. Once
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the implant is in place, the guide tool 178 is removed and the incision
closed. The insertion tools of Figs. 23 and 24 can also be used if
desired.
Embodiment of Figs. 26, 27 and 28
The embodiment shown in Figs. 26, 27 and 28 uses an implant
similar to that depicted in Figs. 8 and 9 with different insertion tools.
As can be seen in Fig. 26, an L-shaped distraction tool 190 is similar
to L-shaped distraction tool 80 (Fig. 12), is used to distract the first
and second spinous processes 192, 194. After this has occurred, an
insertion tool 196 is placed between the spinous processes 192, 194.
Insertion tool 196 includes a handle 198 to which is mounted a
square-shaped ring 200.
The distraction tool 190 can be inserted through a small incision
in the back in order to spread apart the spinous processes. Through
the same incision which has been slightly enlarged laterally, an upper
end 202 of ring 200 can be initially inserted followed by the remainder
of the ring 200. Once the ring is inserted, the ring can be rotated
slightly by moving handle 198 downwardiy in order to further wedge
the spinous processes apart. Once this has been accomplished, an
implant such as implant 204 can be inserted through the ring and
properly positioned using implant handle 206. Thereafter, the implant
handle 206 and the insertion tool 196 can be removed.
Embodiments of Figs. 29. 30. 31, 32 and 33
As can be seen in Figs. 29 and 30, the implants 210, 212, can
have different shapes when viewed from the side. These implants are
similar to the above-referenced implants 58 (Fig. 8) and 204 (Fig. 28).
These implants have cross-sections similar to that shown in Fig. 10
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which includes saddles in order to receive and hold the adjacent
spinous processes.
As can be seen in Figs. 31, 32 and 33, these implants can be
placed in different positions with respect to the spinous process 214.
Preferably as shown in Fig. 33, the implant 210 is placed closest to
the lamina 216. Being so positioned, the implant 210 is close to the
instantaneous axis of rotation 218 of the spinal column, and the
implant would experience least forces caused by movement of the
spine. Thus, theoretically, this is the optimal location for the implant.
As can be seen in Figs. 31 and 32, the implant can be placed
midway along the spinous process (Fig. 32) and towards the posterior
aspect of the spinous process (Fig. 31). As positioned shown in Fig.
31, the greatest force would be placed on the implant 210 due to a
combination of compression and extension of the spinal column.
Embodiment of Figs. 34 and 35
Another embodiment of the invention is shown in Figs. 34 and
35. In these figures, implant 220 is comprised of a plurality of
individual leaves 222 which are substantially V-shaped. The leaves
include interlocking indentations or detents 224. That is, each leaf
includes an indentation with a corresponding protrusion such that a
protrusion of one leaf mates with an indentation of an adjacent leaf.
Also associated with this embodiment is an insertion tool 226 which
has a blunt end 228 which conforms to the shape of an individual leaf
222. For insertion of this implant into the space between the spinous
processes as shown in Fig. 29, the insertion tool 226 first insert a
single leaf 220. After that has occurred, the insertion tool then inserts
a second leaf with the protrusion 224 of the second leaf snapping into
corresponding indentation made by the protrusion 224 of the first leaf.
This process would reoccur with third and subsequent leaves until the
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appropriate spacing between the spinous processes was built up. As
can be seen in Fig. 29, the lateral edges 229 of the individual leaves
222 are slightly curved upwardly in order to form a saddle for receiving
the upper and lower spinous processes.
Embodiments of Figs. 36. 37 and 38
The embodiments of Figs. 36, 37 and 38 which include implants
230, 232, and 234 respectively, are designed in such a manner so the
implant locks itself into position once it is properly positioned between
the spinous processes. Implant 230 is essentially a series of truncated
cones and includes a plurality.of ever expanding steps 236. These
steps are formed by the conical bodies starting with the nose body
238 followed there behind by conical body 240. Essentially, the
implant 230 looks like a fir tree placed on its side.
The implant 230 is inserted laterally throughout the opening
between upper and lower spinous processes. The first body 238
causes the initial distraction. Each successive conical body distracts
the spinous processes a further incremental amount. When the
desired distraction has been reached, the spinous processes are locked
inta position by steps 236. At this point, if desired, the initial nose
body 238 of the implant and other bodies 240 can be broken, snapped
or sawed off if desired in order to minimize the size of the implant 230.
In order for a portion of the implant 230 to be broken or snapped off,
the intersection between bodies such as body 238 and 240, which is
intersection line 242, would be somewhat weaken with the appropriate
removal of material. It is noted that only the intersection lines of the
initial conical bodies need to be so weakened. Thus, intersection line
244 between the bodies which remain between the spinous processes
would not need to be weaker, as there would be no intention that the
implant would be broken off at this point.
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Fig. 37 shows implant 232 positioned between upper and lower
spinous processes. This implant is wedge-shaped or triangular shaped
in cross-sectioned and includes bore pluralities 245 and 246. Through
these bores can be placed locking pins 248 and 250. The triangular
or wedged-shaped implant can be urged laterally between and thus
distract the upper and lower spinous processes. Once the appropriate
distraction is reached, pins 248, 250 can be inserted through the
appropriate bores of the bore pluralities 245 and 246 in order to lock
the spinous processes in a V-shaped valley formed by pins 248, 250
on the one hand and the ramped surface 233, 235 on the other hand.
Turning to Fig. 38, the implant 234 has a triangular-shaped or
wedge-shaped body similar to that shown in Fig. 32. in this
embodiment,tabs 252, 254 are pivotally mounted to the triangular
shaped body. Once the implant 234 is appropriately positioned
in order to distract the spinous processes to the desired amount, the
tabs 252, 254 rotate into position in order to hold the implant 234 in
the appropriate position.
Embodiment of Figs. 39 and 40
In the embodiment of Figs. 39 and 40, cannula 258 is inserted
through a small incision to a position between upper and lower spinous
processes. Once the cannula is properly inserted, an implant 260 is
pushed through the cannula 258 using an insertion tool 262. The
implant 260 includes a plurality of ribs or indentation 264 that assist
in positioning the implant 260 relative to the upper and lower spinal
processes. Once the implant 260 is in position, the cannula 258 is
withdrawn so that the implant 260 comes in contact with and wedges
between the spinous processes. The cannula 258 is somewhat conical
in shape with the nose end 266 being somewhat smaller than the
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distal end 268 in order to effect the insertion of the cannula into the
space between the spinous processes.
Further, a plurality of cannula can be used instead of one, with
each cannula being slightly bigger than one before. In the method of
the invention, the first smaller cannula would be inserted followed by
successively larger cannula being placed over the previous smaller
cannula. The smaller cannula would then be withdrawn from the
center of the larger cannula. Once the largest cannula is in place, and
the opening of the skin accordingly expanded, the implant, which is
accommodated by only the larger cannula, is inserted through the
larger cannula and into position.
Embodiments of Figs. 41, 42 and 43
The precurved implant 270 in Figs. 41 and 42, and precurved
implant 272 in Fig. 43 have common introduction techniques which
includes a guide wire, guide tool, or stylet 274. For both
embodiments, the guide wire 274 is appropriately positioned through
the skin of the patient and into the space between the spinous
processes. After this is accomplished, the implant is directed over the
guide wire and into position between the spinous processes. The
precurved nature of the implant assist in (1) positioning the implant
through a first small incision in the patient's skin on one side of the
space between two spinous processes and (2) guiding the implant
toward a second small incision in the patient's skin on the other side
of the space between the two spinous processes. With respect to the
implant 270, the implant includes a conical introduction nose 276 and
a distal portion 278. As the nose 276 is inserted between the spinous
processes, this causes distraction of the spinous processes. Break
lines 280, 282 are established at opposite sides of the implant 270.
Once the implant is properly positioned over the guide wire between
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the spinous processes, the nose portion 276 and the distal portion 278
can be broken off along the break lines, through the above two
incisions, in order to leave the implant 270 in position.
Although only two break lines 280, 282 are depicted, multiple
break lines can be provided on implant 270 so that the implant can
continue to be fed over the guide wire 274 until the appropriate width
of the implant 270 creates the desired amount of distraction. As
described hereinabove, the break lines can be created by perforating
or otherwise weakening the implant 270 so that the appropriate
portions can be snapped or sawed off.
With respect to the precurved implant 272, this implant is similar
in design to the implant 230 shown in Fig. 36. This implant 272 in
Fig. 47, however, is precurved and inserted over a guide wire 274 to
a position between the spinous processes. As with implant 230 in Fig.
43-, once the appropriate level of this distraction has been reached and
if desired, sections of the implant 272 can be broken, snapped or
sawed off as described hereinabove in order to leave a portion of the
implant wedged between the upper and lower spinous processes.
Embodiment of Fig. 44
A further embodiment of the invention is shown in Fig. 44. This
embodiment includes a combination insertion tool and implant 290.
The insertion tool and implant 290 is in the shape of a ring which is
hinged at point 292. The ring is formed by a first elongated and
conically shaped member 294 and a second elongated and conically
shaped member 296. Members 294 and 296 terminate in points and
through the use of hinge 292 are aligned and meet. Through similar
incisions on both sides of the spinous processes, first member and
second member are inserted through the skins of the patient and are
mated together between the spinous processes. After this has
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occurred, the implant 290 is rotated, for example clockwise, so that
increasingly widening portions 293 of the first member 294 are used to
distract the first and second spinous processes. When the appropriate
level of distraction has occurred, the remainder of the ring before and
after the section which is located between the spinous processes can
be broken off as taught hereinabove in order to maintain the desired
distraction. Alternatively, with a small enough ring, the entire ring can
be left in place with the spinous processes distracted.
Embodiment of Fig. 45
In Fig. 45, the implant 300 is comprised of a plurality of rods or
stylets 302 which are inserted between the upper and lower spinous
processes. The rods are designed much as described hereinabove so
that they may be broken, snapped or cut off. Once these are inserted
and the appropriate distraction has been reached, the stylets are broken off
and a segment of each stylet remains in order to maintain
distraction of the spinous process.
Embodiment of Fi4s. 46 and 47
implant 310 of Figs. 46 and 47 is comprised of a shape memory
material which coils upon being released. The material -is straightened
out in a delivery tool 312. The delivery tool is in position between
upper and lower spinous processes 314, 316. The material is then
pushed through the delivery tool. As it is released from the deiivery
end 318 of the delivery tool, the material coils, distracting the spinous
processes to the desired amount. Once this distraction has been
achieved, the material is cut and the delivery tool removed.
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Embodiments of Figs. 48, 49, 50 and 51
As can be seen in Fig. 48, the impiant 320 is delivered between
upper and lower spinous processes 322 and 324, by delivery tool 326.
Once the implant 320 is in place between the spinous processes, the
delivery tool is given a 90 twist so that the implant goes from the
orientation as shown in Fig. 49, with longest dimension substantially
perpendicular to the spinous processes, to the orientation shown in
Fig. 50 where the longest dimension is in line with and parallel to the
spinous processes. This rotation causes the desired distraction
between the spinous processes. Implant 320 includes opposed
recesses 325 and 323 located at the ends thereof. Rotation of the
implant 320 causes the spinous processes to become lodged in these
recesses.
Alternatively, the insertion tool 326 can be used to insert
multiple implants 320, 321 into the space between the spinous
processes 322, 324 (Fig. 51). Multiple impiants 320, 321 can be
inserted until the appropriate amount of distraction is built up. It is to
be understood in this situation that one implant would lock to another
implant by use of, for example, a channel arrangement wherein a
projection from one of the implants would be received into and locked
into a channel of the other implant. Such a channel arrangement is
depicted with respect to the other embodiment.
Embodiment of Figs. 52 53, 54, 55a and 55b
The embodiment of Figs. 52 through 55b is comprised of a fluid-
filled. dynamic distraction implant 350. This implant includes a
membmne 352 which is placed over pre-bent insertion rod 354 and
then inserted through an incision on one side of the spinous process
356. The bent insertion rod, with the implant 350 thereover, is guided
between appropriate spinous processes. After this occurs, the
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insertion rod 354 is removed leaving the flexible implant in place. The
implant 350 is then connected to a source of fluid (gas, liquid, gel and
the like) and the fluid is forced into the implant causing it to expand as
shown in Fig. 54, distracting the spinal processes to the desired
amount. Once the desired amount of distraction has occurred, the
implant 350 is closed off as is shown in Fig. 55a. The implant 350
being flexible, can mold to the spinous processes which may be of
irregular shape, thus assuring positioning. Further, implant 350 acts
as a shock absorber, damping forces and stresses between the implant
and the spinous processes.
A variety of materials can be used to make the implant and the
fluid which is forced into the implant. By way of example only,
viscoelastic substances such as methylcellulose, or hyaluronic acid can
be used to fill the implant. Further, materials which are initially a fluid,
but later solidify, can be inserted in order to cause the necessary
distraction. As the materials solidify, they mold into a custom shape
about the spinous processes and accordingly are held in position at
least with respect to one of two adjacent spinous processes. Thus, it
can be appreciated that using this embodiment and appropriate
insertion tools the implant can be formed about one spinous process
in such a manner that the implant stays positioned with respect to that
spinous process (Fig. 55b). With such an embodiment, a single
implant can be used as an extension stop for spinous process located
on either side, without restricting flexion of the spinal column.
It is to be understood that many of the other implants disclosed
herein can be modified so that they receive a fluid in order to establish
and maintain a desired distraction much in the manner as implant 350
receives a fluid.
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Embodiment of Figs. 56, 57 and 58
The implant 360 as shown in Fig. 56 is comprised of a shape
memory material such as a plastic or a metal. A curved introductory
tool 362 is positioned between the appropriate spinous processes as
described hereinabove. Once this has occurred, bore 364 of the
implant is received over the tool. This act can cause the implant to
straighten out. The implant is then urged into position and thereby
distracts the spinous processes. When this has occurred, the insertion
tool 362 is removed, allowing the implant to assume its pre-
straightened configuration and is thereby secured about one of the
spinous processes. Such an arrangement allows for an implant that is
an extension stop and does not inhibit flexion of the spinous column.
Alternatively, the implant can be temperature sensitive. That is to say
that the implant would be more straightened initially, but become more
curved when it was warmed by the temperature of the patient's body.
Embodiments of Figs. 59 and 60
In this embodiment, the implant 380 is comprised of a plurality
of interlocking leaves 382. Initially, a first leaf is positioned between
opposed spinous processes 384, 386. Then subsequently, leafs 382
are interposed between the spinous processes until the desired
distraction has been built up. The leaves are somewhat spring-like in
order to absorb the shock and can somewhat conform to the spinous
processes.
Embodiment of Fig. 61
l"he implant 390 of Fig. 61 includes the placement of shields
392, 394 over adjacent spinous processes 396, 398. The shields are
used to prevent damage to the spinous processes. These shields
include apertures which receives a self-tapping screw 400, 402. tn
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practice, the shields are affixed to the spinous processes and the
spinous processes are distracted in the appropriate amount. Once this
has occurred, a rod 404 is used to hold the distracted position by
being screwed into each of the spihous processes through the aperture
in the shields using the screws as depicted in Fig. 61.
Embodiment of Figs. 62 and 63
Implant 410 of Figs. 62, 63 is comprised of first and second
members 412, 414 which can be mated together using an appropriate
screw and threaded bore arrangement to form the implant 410. Main
member 412 and mating member 414 form implant 410. Accordingly,
the implant 410 would have a plurality of members 414 for use with
a standardized first member 412. Figs. 62 and 64 show different
types of mating members 414. In Fig. 62, the mating member 414
includes projections 416 and 418 which act like shims. These
projections are used to project into the space of saddles 420, 422 of
the first member 412. These projections 416, 418 can be of varying
lengths in order to accommodate different sizes of spinous processes.
A groove 424 is placed between the projections 416, 418 and mates
with an extension 426 of the first member 412.
As shown in Fig. 63, the projections of the embodiment shown
in Fig. 62 are removed and recesses 428, 430 are substituted therefor.
These recesses expand the area of the saddles 420, 422 in order to
accommodate larger spinous processes.
Embodiment of Figs. 64, 65 and 66
The embodiments of Figs. 64, 65 and 66 are similar in design
and concept to the embodiment of Figs. 62 and 63. In Fig. 64, the
implant 500 includes the first and second members 502, 504. These
members can be secured together with appropriate screws or other
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fastening means as taught in other embodiments. Implant 500
includes first and second saddles 506, 508 which are formed between
the ends of first and second members 502, 504. These saddles 506,
508 are used to receive and cradle the adjacent spinous processes.
As can be seen in Fig. 64, each saddle 506, 508 is defined by a single
projection or leg 510, 512, which extends from the appropriate first
and second members 502, 504. Unlike the embodiment found in Figs.
62 and 63, each of the saddles is defined by only a single leg as the
ligaments and other tissues associated with the spinous processes can
be used to ensure that the implant is held in an appropriate position.
With the configuration of Fig. 64, it is easier to position the implant
relative to the spinous processes as each saddle is defined by only a
single ieg and thus the first and second members can be more easily
worked into position between the various tissues.
In the embodiment of Fig. 65, the implant 520 is comprised of
a single piece having saddles 522 and 524. The saddles are defined
by a single leg 526, 528 respectively. In order for this implant 520 to
be positioned between the spinous processes, an incision is made
between lateral sides of adjacent spinous processes. The single leg
526 is directed through the incision to a position adjacent to an
opposite lateral side of the spinous process with the spinous process
cradled in the saddie 522. The spinous processes are then urged apart
until saddle 524 can be pivoted into position into engagement with the
other spinous process in order to maintain the distraction between the
two adjacent spinous processes.
The embodiment of Fig. 66 is similar to that of Fig. 65 with an
implant 530 and first and second saddles 532 and 534. Associated
with each saddle is a tether 536, 538 respectively. The tethers are
made of flexible materials known in the trade and industry and are
positioned through bores in the implant 530. Once appropriately
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positioned, the tethers can be tied off. It is to be understood that the
tethers are not meant to be used to immobilize one spinous process
relative to the other, but are used to guide motion of the spinous
processes relative to each other so that the implant 530 can be used
as an extension stop and a flexion non-inhibitor. In other words, the
saddles 532, 534 are used to stop spinal column backward bending
and extension. However, the tethers do not inhibit forward bending
and spinal column flexion.
Embodiments of Figs. 67, 68
The implant 550 is Z-shaped and includes a central body 552
and first and second arms 554, 556, extending in opposite directions
therefrom. The central body 552 of the implant 550 includes first and
second saddles 558 and 560. The first and second saddles 558 and
560 would receive upper and lower spinous processes 562, 568. The
arms 554, 556 are accordingly located adjacent the distal end 566
(Fig. 68) of the central body 552. The first and second arms 554,
556, act to inhibit forward movement, migration or. slippage of the
implant 550 toward the spinal canal and keep the implant in place
relative to the first and second spinal processes. This prevents the
implant from pressing down on the ligamentum flavum and the dura.
In a preferred embodiment, the central body would have a height of
about 10mm with each of the arms 554, 556 have a height of also
about 10mm. Depending on the patient, the height of the body could
vary from about less than 10 mm to about greater than 24mm. As
can be seen in Figs. 67 and 68, the first and second arms 554, 556
are additionally contoured in order to accept the upper and lower
spinous processes 562, 568. !n particular, the arms 554, 556 as can
be seen with respect to arm 554 have a slightly outwardly bowed
portion 568 (Fig. 68) with a distal end 570 which is slightly inwardly
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bowed. This configuration allows the arm to fit about the spinous
process with the distal end 570 somewhat urged against the spinous
process in order to guide the motion of the spinous process relative to
the implant. These arms 554, 556 could if desired to be made more
flexible than the centrai body 552 by making arms 554, 556 thin
and/or with perforations, and/or other material different than that of
the central body 552. As with the last embodiment, this embodiment
can be urged into position between adjacent spinous processes by
directing an arm into a lateral incision so that the central body 552 can
be finally positioned between spinous processes.
Embodiment of Figs. 69, 70, 71 and 71 a
Figs. 69, 70 and 71 are perspective front, end, and side views
of implant 580 of the invention. This implant includes a central body
582 which has first and second saddles 584, 586 for receiving
adjacent spinous processes. Additionally, the implant 580 includes
first and second arms 588 and 590. - The arms, as with the past
embodiment, prevent forward migration or slippage of the implant
toward the spinal canal. First arm 588 projects outwardly from the
first saddle 584 and second arm 590 projects outwardly from the
second saddle 586. In a preferred embodiment, the first arm 588 is
located adjacent to the distal end 600 of the central body 582 and
proceeds only partly along the length of the central body 582. The
first arm 588 is substantially perpendicular to the central body as
shown in Fig. 70. Further, the first arm 588, as well as the second
arm 590, is anatomically rounded.
The second arm 590, projecting from second saddle 586, is
iocated somewhat rearward of the distal end 600., and extends
partially along the length of the central body 582. The second arm
590 projects at a compound angle from the central body 582. As can
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be seen in Figs. 70 and 71, the second arm 590 is shown to be at
about an angle of 45 from the saddie 586 (Fig. 70). Additionally, the
second arm 590 is at an angle of about 45 relative to the length of
the central body 582 as shown in Fig. 71. It is to be understood that
other compound angles are within the spirit and scope of the invention
as claimed.
In a preferred embodiment, the first and second arms 588, 590
have a length which is about the same as the width of the central
body 582. Preferably, the length of each arm is about 10mm and the
width of the central body is about 10mm. However, the bodies with
the widths of 24mm and greater are within the spirit and scope of the
invention, along with first and second arms ranging from about 10mm
to greater than about 24mm. Further, it is contemplated that the
embodiment could include a central body having a width of about or
greater than 24mm with arms being at about 10mm.
It is to be understood that the embodiment of Figs. 69, 70 and
71 as well as the embodiment of Figs. 67 and 68 are designed to
preferably be positioned between the L4-L5 and the - L5-S 1 vertebral
pairs. The embodiment of Figs. 69, 70, 71 is particularly designed for
the L5-S1 position with the arms being designed to conform to the
sloping surfaces found therebetween. The first and second arms are
thus contoured so that they lie flat against the lamina of the vertebra
which has a slight angle.
The embodiment of Fig. 69, 70, and 71 as with the embodiment
of Figs. 67 and 68 is Z-shaped in configuration so that it may be
inserted from one lateral side to a position between adjacent spinous
processes. A first arm, followed by the central body, is guided
through the space between the spinous processes. Such an
arrangement only requires that a incision on one side of the spinous
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process be made in order to successfully implant the device between
the two spinous processes.
The implant 610 of Fig. 71 a is similar to that immediately above
with the first arm 612 located on the same side of the implant as the
second arm 614. The first and second saddle 616, 618 are slightly
modified in that distal portion 620, 622 are somewhat flattened from
the normal saddle shape in order to allow the implant to be positioned
between the spinous processes from one side. Once in position, the
ligaments and tissues associated with the spinous processes would
hold the implant into position. Tethers also could be used if desired.
Embodiment of Figs. 72, 73
Implant 630 is also designed so that it can be inserted from one
side of adjacent spinous processes.This implant 630 includes a central
body 632 with the first and second arms 634, 636 extending on either
side thereof. As can be seen in Fig. 72, a plunger. 638 is positioned
to extend from an end of the central body 632. As shown in Fig. 72,
the plunger 638 is fully extended and as shown in Fig. 73, the plunger
638 is received within the central body 632 of the implant 630. With
the plunger 638 received into the implant 630, the third and fourth arms or
hooks 640, 642 can extend outwardly from the central body 632. The
third and fourth arms or hooks 640, 642 can be comprised of a variety
of materials, such as for example, shape memory metal materials or
materials which have a springy quality.
For purposes of positioning the implant 630 between adjacent
spinous processes, the plunger 638 is pulled outwardly as shown in
Fig. 72. The central body 632 is then positioned between adjacent
spinous processes and the plunger 638 is allowed to move to the
position of Fig. 73 so that the third and fourth arms 640, 642 can
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project outwardly from the central body 632 in order to hold the
implant 630 in position between the spinous processes.
Plunger 638 can be spring biased to the position as shown in
Fig. 73 or can include detents or other mechanisms which lock it into
that position. Further, the third and fourth arms themselves, as
deployed, can keep the plunger in the position as shown in Fig. 73.
Embodiments of Figs. 74, 75, 76. 77, and 78
Other embodiments of the invention are shown in Figs. 74
through 78. Figs. 74, 75 and 76 disclose implant 700. Implant 700
is particularly suited for implantation between the L4-L5 and L5-S1
vertebra. As can be seen in Fig. 74, the implant 700 includes a central
body 702 which has a bore 704 provided therein. Bore 704 is used
in order to adjust the modulus of elasticity of the implant so that it is
preferably approximately two times the anatomical load placed on the
vertebra in extension. In other words, the implant 700 is
approximately two times stiffer than the normal load placed on the
implant. Such an arrangement is made in order to ensure that the
implant is somewhat flexible in order to reduce potential resorption of
the bone adjacent to the implant. Other modulus vaiues can be used
and be within the spirit of the invention.
Implant 700 includes first and second saddle 706, 708 which
are used to receive and spread the load from the upper and lower
spinous processes. The saddle 706 is defined by first and second
arms 710 and 712. The second saddle 708 is defined by third and
fourth arms 714 and 716. As can be seen in Fig. 74, the first arm
710, in a preferred embodiment, is approximateiy two times the length
of the body 702 with the second arm being approximately less than a
quarter length of the body. Third arm 714 is approximateiy one times
the length of the body 702 with the fourth arm 716 being, in this
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preferred embodiment, approximately one and a half times the length
of the body 702. The arms are designed in such a way that the
implant (1) can be easily and conveniently inserted between the
adjacent spinous processes, (2) will not migrate forwardly toward the
spinal canal, and (3) will hold its position through flexion and extension
as well as lateral bending of the spinal column.
First arm 710 is in addition designed to accommodate the shape
of the vertebra. As can be seen in Fig. 74, the first arm 710 becomes
narrower as it extends away from the body 702. The first arm 710
includes a sloping portion 718 followed by a small recess 720 ending
in a rounded portion 722 adjacent to the end 724. This design is
provided to accommodate the anatomical form of for example the L4
vertebra. It is to be understood that these vertebra have a number of
surfaces at roughly 30 angles and that the sloping surfaces of thi's
embodiment and the embodiments shown in Figs. 77 and 78 are
designed to accommodate these surfaces. These embodiments can be
further modified in order to accommodate other angles and shapes.
The second arm 712 is small so that it is easy to insert between
the spinous processes, yet still define the saddle 706. The fourth arm
716 is larger than the third arm 714, both of which are smaller than
the first arm 710. The third and fourth arms are designed so that they
define the saddle 706, guide the spinous processes relative to the
implant 700 during movement of the spinal column, and yet are of a
size which makes the impiant easy to position between the spinous
processes.
The procedure, by way of example only, for implanting the
implant 700 can be to make an incision laterally between two spinous
processes and then initially insert first arm 710 between the spinous
processes. The implant and/or appropriate tools would be used to
distract the spinous processes allowing the third leg 714 and the
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central body 702 to fit through the space between the spinous
processes. The third leg 714 would then come to rest adjacent the
lower spinous processes on the opposite side with the spinous
processes resting in the first and second saddie 706, 708. The longer
fourth leg 716 would then assist in the positioning of the implant 700.
Fig. 77 includes an implant 740 which is similar to implant 700
and thus have similar numbering. The saddle 706, 708 of implant 740
have been cantered or sloped in order to accommodate the bone
structure between, by way of example, the L4-L5 and the L5-S1
vertebra. As indicated above, the vertebra in this area have a number
of sloping surfaces in the range of about 30 . Accordingly, saddle
706 is sloped at less than 30 and preferably about 20 while saddle
708 is sloped at about 30 and preferabiy more than 30 .
The implant 760 as shown in Fig. 78 is similar to implant 700
in Fig. 74 and is similarly numbered. Implant 760 includes third and
fourth legs 714, 716 which have sloping portions 762, 764 which
slope toward ends 766, 768 of third and fourth arm 714, 716
respectively. The sloping portions accommodate the form of the lower
vertebra against which they are positioned. In the preferred
embodiment, the sloping portions are of about 30 . However, it is to
be understood that sloping portions which are substantially greater and
substantially less than 30 can be included and be within the spirit and
scope of the invention.
Embodiment of Fig. 79, 80 80a 81 82, 83, 83a, 84, 85, 86
and 87
Another embodiment of the invention is shown in Figs. 79-87
and includes implant 800a(Fig. 86): Implant 800 includes a distracting
unit 802a which is shown in left side, plan, and right side views of Figs.
79, 80 and 81. A perspective view of the distraction unit is shown in
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Fig. 84. The distracting unit 802a as can be seen in Fig. 80 includes a
distracting body 804, with longitudinal axis 805, which body 804 has
a groove 806 and a rounded or bulbous end 808 which assist in the
placement of the distracting body 804 between adjacent spinous process;
so that an appropriate amount of distraction can be accomplished.
Extending from the distracting body 804 is a first wing 810 which in
Fig. 80 is substantially perpendicular to the distracting body 804.
Such wings which are not perpendicular to the distracting body 804 are within
the
spirit and scope of the invention. First wing 810 includes a upper
portion 812 and a lower portion 814. The upper portion 812 (Fig=.
80) includes a rounded end 816 and a small recess 818. The rounded
end 816 and the small recess 818 in the preferred embodiment are
designed to accommodate the anatomical form or contour of the L4
(for a L4-L5 placement) or L5 (for a L5-S1 placement) superior lamina
of the vertebra. It is to be understood that the same shape or
variations of this shape can be used to accommodate other lamina of
any vertebra. The lower portion 814 is also rounded in order to
accommodate in the preferred embodiment in order to accommodate
the vertebrae. The di$tracting unit 802a further includes a threaded bore
820 which in this embodiment accepts a set screw 822 (Fig. 86) in
order to hold a second wing 824 (Figs. 82, 83) in position as will be
discussed hereinbelow.
The threaded bore 820 in this e,mbodiment slopes at
approximately 45 angle and intersects the slot 806. With the second
wing 824 in position, the set screw 822 when it is positioned in the
threaded bore 820 can engage and hold the second wing 824 in
position in the slot 806.
Turning to Figs. 82, 83 and 85, left side, plan and perspective
views of the second wing 824 are depicted. The second wing 824 is
similar in design to the first wing. The second wing includes an upper
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portion 826 and a lower portion 828. The upper portion includes a
rounded end 830 and a small recess 832. In addition, the second
wing 824 includes a slot 834 which mates with the slot 806 of the
distracting unit 802. The second wing 824 is the retaining unit of the
present embodiment.
As can be seen in Fig. 83 and 86, the second wing or retaining
unit 824 includes the upper portion 826 having a first width "a" and
the lower portion 828 having a second width "b". In the preferred
embodiment, the second width "b" is larger than first width "a" due
to the anatomical form or contour of the L4-L5 or L5-S1 laminae. As
can be seen in Fig. 83a in second wing or retaining unit 824, the
widths "a" and "b" would be increased in order to, as described
hereinbelow, accommodate spinous processes and other anatomical
forms or contours which are of different dimensions. Further, as
appropriate, width "a" can be larger than width "b". Thus, as will be
described more fully hereinbelow, the implant can include a universally-
shaped distracting unit 802 with a plurality of retaining units 824, with
each of the retaining units having different widths "a" and "b". During
surgery, the appropriately sized retaining unit 824, width with the
appropriate dimensions "a" and "b" can be selected to match to the
anatomical form of the patient.
Fig. 86 depicts an assembled implant 800 positioned adjacent
to upper and lower laminae 836, 838 (which are shown in dotted lines)
of the upper and lower vertebrae. The vertebrae 836, 838 are
essentially below the implant 800 as shown in Fig. 86. Extending
upwardly from the vertebrae 836, 838, and between the first and
second wings 810, 824, are the upper and lower spinous processes
840, 842. It is to be understood that in a preferred embodiment, the
fit of the implant between the spinous processes can be such that the
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wings do not touch the spinous processes, as shown in Fig. 86, and
be within the spirit and scope of the invention.
The implant 800 includes, as assembled, an upper saddle 844
and the lower saddle 846. The upper saddle 844 has an upper width
identified by the dimension "UW". The lower saddle 846 has a lower
width identified by the dimension "LW". In a preferred embodiment,
the upper width is greater than the lower width. In other
embodiments, the "UW" can be smaller than the "LW" depending on
the anatomical requirements. The height between the upper and lower
saddles 844, 846 is identified by the letter "h". These dimensions are
carried over into Fig. 87 which is a schematic representation of the
substantially trapezoidal shape which is formed between the upper and
lower saddles. The table below gives sets of dimensions for the upper
width, fower width, and height as shown in Fig. 87. This table
includes dimensions for some variations of this embodiment.
TABLE
Variation 1 2 3
Upper Width 8 7 6
Lower Width 7 6 5
Height 10 9 8
For the above table, all dimensions are given in millimeters.
For purposes of surgical implantation of the implant 800 into a
patient, the patient is preferably positioned on his side (arrow 841
points up from an operating table) and placed in a flexed (tucked)
positioii in order to distract the upper and lower vertebrae.
In a preferred procedure, a small incision is made on the midline
of the spinous processes. The spinous processes are spread apart or
distracted with a spreader. The incision is spread downwardly toward
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the table, and the distracting unit 802 is preferably inserted upwardly
between the spinous processes 840 and 842 in a manner that
maintains the distraction of spinous processes. The distracting unit
802 is urged upwardly until the distracting or bulbous end 808 and the
slot 806 are visible on the other wide of the spinous process. Once
this is visible, the incision is spread upwardly away from the table and
the retaining unit or second wing 824 is inserted into the slot 806 and
the screw 822 is used to secure the second wing in position. After
this had occurred, the incisions can be closed.
An alternative surgical approach requires that small incisions be
made on either side of the space located between the spinous
processes. The spinous processes are spread apart or distracted using
a spreader placed through the upper incision. From the lower incision,
the distracting unit 802 is preferably inserted upwardly between the
spinous processes 840 and 842 in a manner that urges the spinous
processes apart. The distracting unit 802 is urged upwardly until the
distracting or bulbous end 808 and the slot 806 are visible through the
second small incision in the patient's back. Once this is visible, the
retaining unit or second wing 824 is inserted into the slot 806 and the
screw 822 is used to secure the second wing in position. After this
has occurred, the incisions can be closed.
The advantage of either of the above present surgical
procedures is that a surgeon is able to observe the entire operation,
where he can look directly down onto the spinous processes as
opposed to having to view the procedure from positions which are to
the right and to the left of the spinous processes. Generally, the
incision is as small as possible and the surgeon is working in a bloody
and slippery environment. Thus, an implant that can be positioned
directly in front of a surgeon is easier to insert and assemble than an
impiant which requires the surgeon to shift from side to side.
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Accordingly, a top-down approach, as an approach along a position to
anterior line is preferred so that all aspects of the implantation
procedure are fully visible to the surgeon at all times. This aides in the
efficient location of (i) the distracting unit between the spinous
processes, (ii) the retaining unit in the distracting unit, and (iii) finally
the set screw in the distracting unit.
Fig. 80a shows an alternative embodiment of the distracting unit
802a. This distracting unit 802a is similar to distracting unit 802 in
Fig. 80 with the exception that the bulbous end 808a is removable
from the rest of the distracting body 804a as it is screwed into the
threaded bore 809. The bulbous end 808a is removed once the
distracting unit 802a is positioned in the patient in accordance with the
description associated with Fig. 86. The bulbous end 808a can extend
past the threaded bore 820 by about 1 cm in a preferred embodiment.
Embodiment of Figs. 88, 89, 90 and 91
Another embodiment of the invention is shown in Figs. 88, 89,
90 and 91. In this embodiment, the implant is identified by the
number 900. Other elements of implant 900 which are simiiar to
implant 800 are similarly numbered but in the 900 series (for example elements
910,
912, 914, and 916 of the first wing correspond to elements 810, 812, 814, and
816 of
the previous embodiment, and elements 930 and 932 of the second wing
correspond to
elements 830 and 832 of the previous embodiment). For example, the distracting
unit is
identified by the number 902 and this is in parallel with the distracting unit
802 of the
implant 800. The distracting body is identified by the number 904 in parallel
with the
distracting body 804 of implant 800. Focusing on Fig. 90, the distracting unit
902 is
depicted in a perspective view. The distracting unit includes slot 906 which
is wider at
the top than at the bottom. The reason for this is that the wider upper
portion of the slot
906, which is wider than the second wing 924 (Fig. 89), is used to allow the
surgeon to
easily place the second wing 924 into the slot 906 and allow the wedge-shaped
slot 906
to guide the second wing 924 to its
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final resting position. As can be see in Fig. 91, in the final resting
position, the largest portion of the slot 906 is not completely filled by
the second wing 924.
The end 908 of implant 900 is different in that it is more
pointed, having sides 909 and 911 which are provided at about 45
angles (other angles, such as by way of example only, from about 30
to about 60 are within the spirit of the invention), with a small flat tip
913 so that the body 904 can be more easily urged between the
spinous processes.
. The distracting unit 902 further includes a tongue-shaped recess
919 which extends from the slot 906. Located in the tongue-shaped
recess is a threaded bore 920.
As can be seen in Fig. 89, a second wing. 924 includes a tongue
948 which extends substantially perpendicular thereto and between
the upper and lower portions 926, 928. The tab 948 includes a bore
950. With the second wing 924 positioned in the slot 906 of the
distracting unit 902 and tab 948 positioned in recess 919, a threaded
set screw 922 can be positioned through the bore 950 and engage the
threaded bore 920 in order to secure the second wing or retaining unit
924 to the distracting unit 902. The embodiment 900 is implanted in
the same manner as embodiment 800 previously described. In
addition, as the bore 920 is substantially perpendicular to the
distracting body 904 (and not provided at an acute angle thereto), the
surgeon can even more easily secure the screw in place from a
position directly behind the spinous processes.
Embodimerit of Figs. 92 92a 92b, 93, 93a, 93b, 93c, 93d, 94,
94a, 94b, 95, 95a, and 96
Still a further embodiment of the invention is depicted in Figs.
92, and 92a. In this embodiment, the implant 1000 as can be seen in
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Fig. 92a includes a central elongated body 1002 which has positioned
at one end thereof a first wing 1004. Wing 1004 is similar to the first
wing previously described with respect to the embodiment of Fig. 88.
Bolt 1006 secures wing 1004 to body 1002 in this embodiment. Bolt
1006 is received in a bore of the body 1002 which is along the
longitudinal axis 1008 of body. It is to be understood that in this
embodiment, the first unit is defined by the central body 1002, the
first wing 1004, and the guide 1010.
Alternatively, the first wing can be secured to the central body
with a press fit and detent arrangement as seen in Fig. 93c. In this
arrangement, the first wing has a protrusion 1040 extending preferably
about perpendicularly from the first wing, with a flexible catch 1042.
The protrusion and flexible catch are press fit into a bore 1044 of the
central body with the catch received in a detent 1046.
In yet another alternative embodiment, the first wing can be
designed as shown in Fig. 93d with the protrusion directed
substantially parallel to the first wirig from a member that joins the first
wing to the protrusion. Thus in this embodiment, the first wing is
inserted into the body along the same direction as the second wing is
inserted.
Positioned at the other end of the central body 1002 is a guide
1010. In this particular embodiment, guide 1010 is essentially
triangularly-shaped so as to be a pointed and arrow-shaped guide.
Alternatively, guide 1010 could be in the shape of a cone with lateral
truncated sides along the longitudinal axis 1008. Guide 1010 includes
a recess 1012 having a threaded bore 1014. Recess 1012 is for
receiving a second wing 1032 as will be described hereinbelow.
Additionally, it is also to be understood that the guide 1010 can
be bulbous, cone-shaped, pointed, arrow-shaped, and the like, in order
to assist in the insertion of the implant 1000 between adjacent spinous
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processes. It is advantageous that the insertion technique disturb as
little of the bone and surrounding tissue or ligam.ents as possible in
order to (1) reduce trauma to the site and facilitate early healing, and
(2) not destabilize the normal anatomy. It is to be noted that with the
present embodiment, there is no requirement to remove any of the
bone of the spinous processes and depending on the anatomy of the
patient, there may be no requirement to remove or sever ligaments and
tissues immediately associated with the spinous processes.
The implant 1000 further includes a sleeve 1016 which fits
around and is at least partially spaced from the central body 1002. As
will be explained in greater detail below, while the implant may be
comprised of a bio-compatible material such as titanium, the sleeve is
comprised preferably of a super-elastic material which is by way of
example only, a nickel titanium material (NiTi), which has properties
which allow it to withstand repeated deflection without fatigue, while
returning to its original shape. The sleeve could be made of other
materials, such as for example titanium, but these materials do not
have the advantages of a super-elastic material.
Fig. 93a is a cross-section through the implant 1000 depicting
the central body 1002 and the sleeve 1016. As can be seen from the
cross-section of Fig. 93a in a preferred embodiment, both the central
body 1002 and the sleeve 1016 are substantially cylindrical and oval
or ecliptically-shaped. An oval or elliptical shape allows more of the
spinous process to be supported by the sleeve, thereby distributing the
load between the bone and the sleeve more evenly. This reduces the
possibility of fracture to the bone or bone resorption. Additionally, an
oval or elliptical shape enhances the flexibility of the sleeve as the
major axis of the sleeve, as described below, is parallel to the
longitudinal direction of the spinous process. However, other shapes
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such as round cross-sections can come within the spirit and scope of
the invention.
In this particular embodiment, the central body 1002 includes
elongated grooves 1018, along axis 1008, which receives elongated
spokes 1020 extending from the internal surface of the cylinder 1016.
In a preferred embodiment, both the cross-section of the central
body and the sleeve have a major dimension along axis 1022 and a
minor dimensional along axis 1024 (Fig. 93a). The spokes 1020 are
along the major dimension so that along the minor dimension, the
sleeve 1016 can have its maximum inflection relative to the central
body 1002. It is to be understood that the central body along the
minor dimension 1024 can have multiple sizes and can, for example,
be reduced in thickness in order to increase the ability of the sleeve
1016 to be deflected in the direction of the central body 1002.
Alternatively as can be seen in Fig. 93b, the central body 1002
can include the spokes 1020 and the sleeve 1016 can be designed to
include the grooves 1018 in order to appropriately space the sleeve
1016 from the central body 1002.
In other embodiments, the sleeve can have minor and major
dimensions as follows:
Minor Dimension Major Dimension
6 mm 10 mm
8mm 10.75 mm
12 mm 14 mm
6 mm 12.5 mm
8 mm 12.5 mm
10mm 12.5mm
In one preferred embodiment, said sleeve has a cross-section
with a major dimension and a minor dimension and said major
dimension is greater than said minor dimension and less than about
two times said minor dimension. In said embodiment, said guide has
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a cross-section which is adjacent to said sleeve with a guide major
dimension about equal to said sleeve major dimension and a guide
minor dimension about equal to said sleeve minor dimension. Further
in said embodiment, said guide extends from said central body with a
cross-section which reduces in size in a direction away from said
central body.
In another preferred embodiment, said guide is cone-shaped with
a base located adjacent to said sleeve. Further, said guide has a base
cross-section about the same as the oval cross-section of said sleeve.
Thus, from the above, it is evident that preferably a major
dimension of the sleeve correspond with a major dimension of the
central body and a minor dimension of the sieeve corresponds with a
minor dimension of the central body. Additionally, it is evident that
the major dimension of the sleeve 1016 is substantially perpendicular
to a major dimension of the first wing 1004 along longitudinal axis
1030 (Fig. 92a). This is so that as discussed above, when the implant
1000 is properly positioned between the spinous processes, a major
portion of the sleeve comes in contact with both the upper and lower
spinous processes in order to distribute the load of the spinous
processes on the sleeve 1016 during spinal column extension.
As indicated above, the preferred material for the sleeve 1016
is a super-elastic material and more preferably one comprised of an
alloy of nickel and titanium. Such materials are available under the
trademark Nitinol. Other super-elastic materials can be used as long
as they are bio-compatible and have the same general characteristics
of super-elastic materials. In this particular embodiment, a preferred
super-elastic material is made up of the following composition of
nickel, titanium, carbon, and other materials as follows:
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Nickel 55.80% by weight
Titanium 44.07% by weight
Carbon <0.5% by weight
Oxygen < 0. 5% by weight
In particular, this composition of materials is able to absorb
about 8% recoverable strain. Of course, other materials which can
absorb greater and less than 8% can come within the spirit and scope
of the invention. This material can be repeatably deflected toward the
central body and returned to about its original shape without fatigue.
Preferably and additionally, this material can withstand the threshold
stress with only a small amount of initial deforming strain and above
the threshold stress exhibit substantial and about instantaneous
deformation strain which is many times the small amount of initial
deforming strain. Such a characteristic is demonstrated in Fig. 118
where it is shown that above a certain threshold stress level,
deformation strain is substantially instantaneous up to about 8%. Fig.
118 shows a loading and unloading curve between stress and
deformation strain for a typical type of super-elastic material as
described above.
Preferably, the above super-elastic material is selected to allow
deformation of up to about, by way of example only, 8%, at about 20
lbs. to 50 lbs. force applied between a spinous processes. This would
cause a sleeve to deflect toward the central body absorbing a
substantial amount of the force of the spinous processes in extension.
Ideally, the sleeves are designed to absorb 20 lbs. to 100 lbs. before
exhibiting the super-elastic effect (threshold stress level) described
above. Further, it is possible, depending on the application of the
sleeve and the anatomy of the spinal column and the pairs of spinous
processes for a particular individual, that the sleeve can be designed
for a preferable range of 20 lbs. to 500 lbs. of force before the
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threshold stress level is reached. Experimental results indicate that
with spinous processes of an older individual, that at about 400
pounds force, the spinous process may fracture. Further, such
experimental results also indicate that with at least 100 pounds force,
the spinous process may experience some compression. Accordingly,
ideally the super-elastic material is designed to deform or flex at less
than 100 pounds force.
In a preferred embodiment, the wall thickness of the sleeve is
about 1 mm or 40/1000 of an inch (.040 in.). Preferably the sleeve is
designed to experience a combined 1 mm deflection. The combined
1 mm deflection means that there is 1/2 mm of deflection at the top of
the minor dimension and a'/h mm deflection at the bottom of the minor
dimension. Both deflections are toward the central body.
In a particular embodiment where the sleeve is more circular in
cross-section, with an outer dimension of 0.622 in. and a wall
thickness of 0.034 in., a 20 lb. load causes a 0.005 in. deflection and
a 60 lb. load causes a 0.020 in. deflection (approximately 1/2 mm). A
100 lb. load would cause a deflection of about 0.04 in. or
approximately 1 mm.
Thus in summary, the above preferred super-elastic material
means that the sleeve can be repeatedly deflected and returned to
about its original shape without showing fatigue. The sleeve can
withstand a threshold stress with a small amount of deforming strain
and at about said threshold stress exhibit about substantiaiiy
instantaneous deformation strain which is many times the small
amount of the forming strain. In other words, such super-elastic
qualities mean that the material experiences a plateau stress where the
material supports a constant force (stress) over very large strain range
as exhibited in Fig. 118.
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It is to be understood that for this particular embodiment, bar
stock of the super-elastic material is machined into the appropriate
form and then heat treated to a final temperature to set the shape of
the material by increasing the temperature of the material to 932
Fahrenheit and holding that temperature for five (5) minutes and then
quickly quenching the sleeve in water. It is also to be understood that
preferably the present nickel titanium super-elastic alloy is selected to
have a transition temperature Af of about 59 Fahrenheit (15 C).
Generally for such devices the transition temperature can be between
15 C to 65 C (59 F to 149 F), and more preferably 10 C to 40 C
(50 F to 104 F). Preferably, the material is maintained in the body
above the transition temperature in order to exhibit optimal elasticity
qualities.
Alternatively, and preferably, the sleeve can be fabricated by
wire Electrical Discharge Machining (EDM) rather than machined.
Additionally, the sleeve can be finished using a shot blast technique in
order to increase the surface strength and elasticity of the sleeve.
Top and side views of the second wing 1032 are shown in Figs.
94 and 95. Second wing 1032 as in several past embodiments
includes a tab 1034 with a bore 1036 which aligns with the bore 1014
of the guide 1010. In this particular embodiment, the second wing
1032 includes a cut-out 1038 which is sized to fit over the guide
1010, with the tab 1034 resting in the recess 1012 of the guide 1010.
An alternative configuration of the second wing 1032 is
depicted in Fig. 94a. In this configuration, the second wing 1032 is
held at acute angle with respect to the tab 1034. This is different
from tt-e situation in the embodiment of Figs. 94 and 95 where the
second wing is substantially perpendicular to the tab. For the
embodiment of the second wing in Fig. 94a, such embodiment will be
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utilized as appropriate depending on the shape of the spinous
processes.
With respect to the alternative second wing 1032 depicted in
Figs. 94b and 95a, elongated tab 1034 has a plurality of closely
positioned bores 1036. The bores, so positioned, appear to form a
scallop shape. Each individual scallop portion of the bore 1036 can
selectively hold the bolt in order to effectively position the second
wing 1032 in three different positions relative to the first wing 1004.
The cut-out 1038 (Fig. 95a of this alternative embodiment) is enlarged
over that of Fig. 95 as in a position closest to the first wing 1004, the
second wing 1032 is immediately adjacent and must conform to the
shape of the sleeve 1016.
Embodiment of Fig. 97
Implant 1050 of Fig. 97 is similar to the implant 1000 in Fig. 92
with the major difference being that a second wing is not required.
The implant 1050 includes a central body as does implant 1000. The
central body is surrounded by a sleeve 1016 which extends between
a first wing 1004 and a guide 1010. The guide 1010 in this
embodiment is substantially cone-shaped without any flats and with no
bore as there is no need to receive a second wing. The sleeve and the
central body as well as the first wing and guide act in a manner similar
to those parts of the implant 1000 in Fig. 92. It is to be understood
a cross-section of this implant 1050 through sleeve 1016 can
preferably be like Fig. 93a. This particular embodiment would be
utilized in a situation where it was deemed impractical or unnecessary
to use a second wing. This embodiment has the significant
advantages of the sleeve being comprised of super-elastic alloy
materials as well as the guide being utilized to guide the implant
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between spinous processes while minimizing damage to the ligament
and tissue structures found around the spinous processes.
Embodiment of Fig. 98
Implant 1060 is depicted in Fig. 98. This implant is similar to
the implants 1000 of Fig. 92 and the implant 1050 of Fig. 97, except
that this implant does not have either first or second wings. Implant
1060 includes a sleeve 1016 which surrounds a central body just as
central body 1002 of implant 1000 in Fig. 93. It is to be understood
that a cross-section of this implant 1060 through sleeve 1016 can
preferably be like Fig. 93a. Implant 1060 includes a guide 1010 which
in this preferred embodiment is cone-shaped. Guide 1010 is located
at one end of the central body. At the other end is a stop 1062. Stop
1062 is used to contain the other end of the sleeve 1016 relative to
the central body. This embodiment is held together with a bolt such
as bolt 1006 of Fig. 93 that is used for the immediate above two
implants. For the implant 1060 of Fig. 98, such a device would be
appropriate where the anatomy between the spinous processes was
such that it would be undesirable to use either a first or second wing.
However, this embodiment affords all the advantageous described
hereinabove (Figs. 92 and 97) with respect to the guide and also with
respect to the dynamics of the sleeve.
Embodiment of Figs. 99 and 100
Figs. 99 and 100 depict an implant system 1070. Implant
system 1070 inciudes a sleeve 1072 which is similar to and has the
advantageous of sleeve 1016 of the embodiment in Fig. 92. Sleeve
1072 does not, however, have any spokes. Additionally, implant
system 1070 includes an insertion tool 1074. Insertion tool 1074
includes a guide 1076 which in a preferred embodiment is substantially
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cone-shaped. Guide 1076 guides the insertion of the sleeve 1072 and
the insertion tool 1074 between adjacent spinous processes. The
insertion tool 1074 further includes a central body 1078, a stop 1080,
and a handle 1082. The guide 1076 at its base has dimensions which
are slightly less than the internal dimensions of the sleeve '1072 . so
that the sleeve can fit over the guide 1076 and rest against the stop
1080. The tool 1074 with the guide 1076 is used to separate tissues
and ligaments and to urge the sleeve 1072 in the space between the
spinous processes. Once positioned, the guide insertion tool 1074 can
be removed leaving the sleeve 1072 in place. If desired, after the
sleeve is positioned, position maintaining mechanisms such as springy
wires 1084 made out of appropriate material such as the super-elastic
alloys and other materials including titanium, can be inserted using a
cannula through the center of the sleeve 1072. Once inserted, the
ends of the retaining wires 1084 (Fig. 99) extend out of both ends of
the sleeve 1072, and due to this springy nature, bent at an angle with
respect to the longitudinal axis of the sleeve 1072. These wires help
maintain the position of the sleeve relative to the spinous processes.
Embodiment of Figs. 101, 102, 102a 103, 104, 105, 106, and
107
Another embodiment of the invention can be seen in Fig. 101
which includes implant 1100. Implant 1100 has many similar features
that are exhibited with respect to implant 1000 in Fig. 92.
Accordingly, elements with similar features and functions would be
similarly numbered. Additionally, features that are different from
implant 1100 can be, if desired, imported into and become a part of
the implant 1000 of Fig. 92.
As with implant 1000, implant 1100 includes a central body
1002 (Fig. 102) with a first wing 1004 and a bolt 1006 which holds
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the first wing and the central body together. In this particular
embodiment, the central body is made in two portions. The first
portion 1102 is in the shape of a truncated cone with an oval or
elliptical base and a second portion 1104 includes a cylindrical central
portion with a distal end in the shape of a truncated cone 1103 with
an oval or elliptical base. In addition, in this particular embodiment,
formed with the central body is the guide 1010 which has an oval or
elliptical base. Bolt 1006 is used to secure the first wing through the
second portion 1104 with the first portion 1102 held in-between. In
this particular embodiment, the guide 1010 in addition to including
recess 1012 and bore 1014 includes a groove 1106 which receives a
portion of the second wing 1032.
In this particular embodiment, the sleeve 1016 is preferably oval
or elliptical in shape as can be seen in Fig. 102a. The central body can
be oval, elliptical or circular in cross-section, although other shapes are
within the spirit and scope of the invention. The sleeve 1016 held in
position due to the fact that the truncated conical portion 1 102 and
the corresponding truncated conical portion 1103 each have a base
that is elliptical or oval in shape. Thus, the sleeve is held in position
so that preferably the major dimension of the elliptical sleeve is
substantially perpendicular to the major dimension of the first wing.
It is to be understood that if the first wing is meant to be put beside
the vertebrae so that the first wing is set at an angle other than
perpendicular with respect to the vertebrae and that the sleeve may be
held in a position so that the major dimension of the sleeve is at an
angle other than perpendicular to the major dimension of the first wing
and be within the spirit and scope of the invention. This could be
accomplished by tightening bolt 1006 with the first wing 1004 and
sleeve 1016 so positioned. In such a configuration, the major
dimension of the sleeve would be preferably positioned so that it is
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essentially parallel to the length of the adjacent spinous processes. So
configured, the elliptical or oval shape sleeve would bear and distribute
the load more evenly over more of its surface.
It is to be understood that the sleeve in this embodiment has all
the characteristics and advantages described hereinabove with respect
to the above-referenced super-elastic sleeves.
The second wing as discussed above, can come in a variety of
shapes in order to provide for variations in the anatomical form of the
spinous processes. Such shapes are depicted in Figs. 103, 104, 105,
106, and 107. In each configuration, the second wing 1032 has a
upper portion 1108 and a lower portion 1110. In Fig. 104, the lower
portion is thicker than the upper portion in order to accommodate the
spinous process, where the lower spinous process is thinner than the
upper spinous process. In Fig. 105, both the upper and lower portions
are enlarged over the upper and lower portions of Fig. 103 to
accommodate both the upper and lower spinous processes being
smaller. That is to say that the space between the upper and lower
portions of the first and second wings are reduced due to the enlarged
upper and lower portions of the second wing.
Alternative embodiments of second wings, as shown in Figs.
104 and 105, are depicted in Figs. 106 and 107. In these Figs. 106
and 107, the second wing 1032 accommodates the same anatomical
shape and size of the spinous processes as does the second wing in
Figs. 104 and 105 respectively. However, in the embodiments of the
second wing 1032 of Figs. 106 and 107, substantial masses have
been removed from the wings. The upper and lower portions 1108
and 1110 are essentially formed or bent in order to extend from the
central portion 1112 of the second wing 1032.
It is to be understood that in this embodiment, if desired, the
second wing may not have to be used, depending on the anatomy of
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the spinal column of the body, and this embodiment still has the
significant advantages attributable to the guide 1010 and the
functionality of the sieeve 1016.
Embodiment of Figs. 108, 109, and 110
The implant 1120 as shown in Figs. 108 and 109, is similar to
implant 1100 which is in turn similar to implant 1000. Such similar
details have aiready been described above and reference here is made
to the unique orientation of the first and second wings 1122 and
1124. These wings have longitudinal axis 1126 and 1128
respectfully. As can be seen in these figures, the first and second
wings 1122, 1124 have been rotated so that they both slope inwardly
and if they were to continue out of the page of the drawing of Fig.
108, they would meet to form an A-frame structure as is evident from
the end view of Fig. 109. In this particular embodiment, as can be
seen in Figs. 109 and 110, the tab 1034 is provided an acute angle to
the remainder of the second wing 1124. Further, the groove 1018
formed in the implant is sloped in order to accept the second wing
1124. Accordingly, this present implant 1120 is particularly suited for
an application where the spinous process is wider adjacent to the
vertebral body and then narrows in size at ieast some distance distally
from the vertebral body. It is to be understood that a cross-section of
this implant 1120 through sleeve 1016 can preferably be like Fig. 93a.
Embodiment of Figs. 111, 112, 113, 114, 115, 116, and 117
An additional embodiment of the implant 1150 is shown in Fig.
111. Implant 1150 has features similar to those described with
respect to Fig. 94b.
Implant 1150 includes a central body 1152 with a first wing
1154, where central body 1152 includes elongated groove 1156
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which extends to the guide 1158. A screw 1160 is received in a
threaded bore located in the elongated groove 1156.
The second wing 1162 includes a central body 1164 which is
substantially perpendicular to the second wing 1162.
The central body 1164 includes a plurality of bores 1166
provided therein. These bores are formed adjacent to each other in
order to define a plurality of scallops, each scallop capable of retaining
bolt 1160 therein. As can be seen in Fig. 114, the second wing
includes a cut-out 1 168 such that with the central body 1164 of the
second wing received in the groove 1156 of the central body
associated with the first wing, the remainder of the second wing is
received over the central body 1152 of the implant 1150. With this
implant 1150, the distance between the first and second wings can be
adjusted by selectively placing the bolt 1 160 through one of the five
specified bores defined by the scalloped plurality of bores 1166.
Accordingly, Fig. 112 depicts the implant where the first and second
wings are widest apart in order to accommodate spinous processes of
greater thickness. Fig. 111 shows the middle position between the
first and second wings in order to accommodate average size spinous
processes.
It is to be understood that preferably during the surgical
process, the central body 1 152 is urged between spinous processes.
After this has occurred, the second wing is guided by the other sides
of the spinous processes from a path which causes the plane of the
second wing to move substantially parallel to the plane of the first
wing until the central body 1164 associated with the second wing
1162 is received in the groove of 1156 of the central body 1152
associated with the first wing 1154. After this has occurred, the bolt
1160 is positioned through aligned bores associated with the second
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wing 1162 and the central body 1152 in order to secure the second
wing to the central body.
While embodiment 1150 does not depict a sleeve such as sleeve
1016, such a sleeve 1016 could be placed over body 1152 and be
within the spirit of the invention.
Embodiments of Figs. 119a, 119b, 120a, 120b, 121a, 121 b,
122a, 122b, 122c 123a, 123b, 124a, 124b, and 124c
Implant 1200 of the invention is depicted in Figs. 119a and
11 9b. This implant includes the first wing 1202 and sleeve 1204 and
a guide 1206. An alternative to this embodiment further includes, as
required, second wing 1208 as depicted in Figs. 120a and 120b.
As can be seen in Fig. 121a and 121b, the first wing 1202
includes a bore which receives a central body 1210. Preferably, the
central body is pressed fit through the bore of the first wing although
it is to be understood that other securing mechanisms such as through
the use of threads and still other mechanisms can be used to
accomplish this task. Additionally, in this particular embodiment first
and second pins 1212 extend from the first wing 1202, each along an
axis which is substantially parallel to the longitudinal axis 1214 of the
central body 1210. In this particular embodiment, the distal end 1216
of the central body 1210 is threaded in order to be coupled to the
guide 1206.
As can be seen in Figs. 122a, 122b and 122c, the guide 1206
in this particular embodiment is pointed in order to allow the implant
to be inserted between, and if necessary distract, adjacent spinous
processes. The guide 206 includes a threaded bore 1218 which is
designed to accept the threaded end 1216 of the central body 1210
in order to secure the guide to the central body and additionally for
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purposes of retaining the sleeve between the guide 1206 and the first
wing 1202.
As can be seen in Fig. 123a the sleeve 1204 is preferably
cylindrical, and oval or elliptical in shape in cross-section. It is to be
understood that sleeve 1204 can have other shapes as described
throughout the specification and be within the spirit and scope of the
invention. In this particular embodiment, sleeve 1204 has at least one
major diameter and one minor diameter in cross-section. Sleeve 1204
includes a central bore 1220 which extends the length of sleeve 1204
and curve grooves 1222 which are formed about central bore 1220
and extend only part way into the body of the sleeve. In this particular
embodiment, the curved grooves 1222 describe an arc of about 60 .
It is to be understood that in other embodiment, this arc can be less
than 600 and extend past 120 .
The sleeve 1204 is received over the central body 1210 of the
implant 1200 and can rotate thereon about the longitudinal axis 1214
of the central body 1210. When this particular embodiment is
assembled, the grooves 1222 have received therein the pins 1212 that
extend from-the first wing 1202. Accordingly, the pins inserted in the
grooves 1222 assist in the positioning of the sleeve relative to the
remainder of the implant 1200. With the pins 1212 received in the
curved grooves 1222, the pins limit the extent of the rotation of the
sleeve about the central body and relative to the first wing.
As can be seen in Figs. 124a, 124b, and 124c, the sleeve is
free to rotate relative to the longitudinal axis of the central body 1210
and thus relative to the first wing 1202 of the embodiment shown in
Figs. 11 9a and 11 9b. The sleeve can rotate relative to a second wing
1208, when the second wing is utilized in conjunction with the
embodiment of Figs. 11 9a and 11 9b. The pins limit the rotation of the
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sleeve. In an alternative embodiment, the pins are eliminated so that
the sleeve can rotate to any position relative to the first wing.
It is to be understood that the sleeve can be comprised of
biologically acceptable material such as titanium. Additionally, it can
be comprised of super-elastic material such as an alloy of nickel and
titanium, much as described hereinabove with respect to other
embodiments.
The great advantage of the use of the sleeve 1204 as depicted
in the embodiment of Figs. 11 9a and 1 19b is that the sleeve can be
rotated and repositioned with respect to the first wing 1202, and/or
the second wing 1208 should the second wing be used in the
embodiment, in order to more optimally position the implant 1200
between spinous processes. It is to be understood that the cortical
bone or the outer shell of the spinous processes is stronger at an
anterior position adjacent to the vertebral bodies of the vertebra that
at a posterior position distally located from the vertebral bodies.
Accordingly, there is some advantage of having the implant 1200
placed as close to the vertebral bodies as is possible. In order to
facilitate this and to accommodate the anatomical form of the bone
structures, as the implant is inserted between the vertebral bodies and
urged toward the vertebral bodies, the sleeve 1204 can be rotated
relative to the wings, such as wing 1202, so that the sieeve is
optimally positioned between the spinous processes, and the wing
1202 is optimally positioned relative to the spinous processes.
Without this capability, depending on the anatomical form of the
bones, it is possible for the wings to become somewhat less than
optimally positioned relative to the spinous processes.
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Embodiments of Figs. 125, 126, and 127
Figs. 125, 126 and 127 depict three alternative embodiments of
the invention as can be seen through a line parallel to line 124-124 of
Fig. 119b.
In Fig. 125, the sleeve 1204 is rotatable about central body
1210. In this embodiment, however, the sleeve 1204 design does not
include the grooves 1222 as previously depicted in the embodiment
shown in Fig. 123a. Thus, without pins, the sleeve is completely free
to rotate about the central body 1210.
An alternative embodiment is shown in Fig. 126. In this
embodiment, the sleeve 1204 is essentially a thin wall cylinder which
is spaced from the central body 1210. Sleeve 1204 is free to move
relative to central body 1210. Sleeve 1204 can rotate relative to
central body 1210. In addition, sleeve 1204 can take a somewhat
cocked or skewed position relative to central body 1210.
A further embodiment, it is shown in Fig. 127. This
embodiment is somewhat similar to the embodiment shown in Fig. 126
except that in this case, several pins project from the first wing in
order to somewhat limit and restrict the motion of the sleeve 1204.
As shown in Fig. 127, four pins are depicted. It is to be understood
however that such an embodiment can include one, two, three, four
or more pins and be within the spirit and scope of the invention. It is
to be understood that if the embodiment is used with a second wing,
that similar pins can extend from the second wing. However, in the
embodiment using a second wing, the pins would preferably be
somewhat flexible so that they could snap into the inside of the sleeve
1204 as the second wing is inserted relative to the central body and
secured in place. In the embodiment shown in Fig. 127, the sleeve
1204 is free to rotate about the longitudinal axis of the central body
1210 and is somewhat restricted in this motion and its ability to
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become skewed relative to the longitudinal axis of the central body by
the pins.
Embodiments of Figs. 128 and 129
The embodiments of Fig. 128 is an advantageous alternative to
that of Fig. 93a. in this embodiment, the central body 1002 is similar
to that as shown in Fig. 93a. The sleeve 116 is comprised of two
sleeve portions 1016a and 1016b. The sleeve portions are preferably
formed from flat stock material which is substantially easier to form
than having the sleeve formed or machined from solid bar stock
material. A further advantage of the sleeve 1016, if formed of super-
elastic material, is that the sleeve can be formed in a manner which
optimizes the super-elastic characteristics of such material in order to
enhance its ability to repeatedly deflect under load. In this particular
embodiment, the sleeve portions 1016a and 1016b are somewhat C-
shaped and then after being formed, are snapped into the grooves of
the central body 1002.
An alternative embodiment of the invention is shown in Fig.
128. This embodiment is most favorably used with the embodiment
of Fig. 11 9a and 11 9b. In this particular embodiment, the sleeve 1204
is designed to rotate about the central body 1210. Sleeve 1204
includes a central member 1230 which includes a bore that receives
the central body 1210. The centrai member 1230 is rotatable about
the central body 1210 of the implant 1200. The central member 1230
includes first and second grooves 1232 and 1234. These grooves can
receive C-shaped sleeve members 1204a and 1204b. These C-shaped
sleeve members are similar in construction and design to the C-shaped
sleeve members shown above with respect to Fig. 128. These sleeve
members can be snapped into position relative to the central member
1230 of the sleeve 1204. It is to be understood that other
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mechanisrns can be used to secure the C-shaped sleeve member
relative to the central member of the sleeve and be within the spirit
and scope of the invention. Further, it is to be understood that the
sleeve members 1204a and 1204b can be formed from a single flat
stock material such that one of the grooves 1232 and 1234 receives
continuous piece of flat material which has been appropriately bent
and the other grooves receives two ends of the sleeve.
Industrial AQplicability
From the above, it is evident that the present invention can be
used to relieve pain caused by spinal stenosis in the form of, by way
of example only, central canal stenosis or foraminal (lateral) stenosis.
These implants have the ability to flatten the natural curvature of the
spine and open the neural foramen and the spacing between adjacent
vertebra to relieve problems associated with the above-mentioned
lateral and central stenosis. Additionally, the invention can be used to
relieve pain associated with facet arthropathy. The present invention
is minimally invasive and can be used on an outpatient basis.
Additional aspects, objects and advantages of the invention can
be obtained through a review of the appendant claims and figures.
It is to be understood that other embodiments can be fabricated
and come within the spirit and scope of the claims.
