U.S. patent application number 12/182437 was filed with the patent office on 2009-08-06 for medical implants and methods.
Invention is credited to Christopher U. PHAN.
Application Number | 20090198338 12/182437 |
Document ID | / |
Family ID | 42359514 |
Filed Date | 2009-08-06 |
United States Patent
Application |
20090198338 |
Kind Code |
A1 |
PHAN; Christopher U. |
August 6, 2009 |
MEDICAL IMPLANTS AND METHODS
Abstract
An apparatus includes a spacer and an actuator. The spacer has a
first spacer member configured to engage an endplate of a first
vertebra and a second spacer member configured to engage an
endplate of a second vertebra. The actuator has a first actuator
member and a second actuator member coupled to the first actuator
member. Each of the first actuator member and the second actuator
member is matingly and movably coupled to the first spacer member
and the second spacer member. The actuator is configured to move
the spacer between a first configuration and a second
configuration. The first spacer member is in contact with the
second spacer member when the spacer is in the first configuration.
The first spacer member is spaced apart from the second spacer
member by a non-zero distance when the spacer is in the second
configuration.
Inventors: |
PHAN; Christopher U.; (San
Leandro, CA) |
Correspondence
Address: |
MEDTRONIC;Attn: Noreen Johnson - IP Legal Department
2600 Sofamor Danek Drive
Memphis
TN
38132
US
|
Family ID: |
42359514 |
Appl. No.: |
12/182437 |
Filed: |
July 30, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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61025991 |
Feb 4, 2008 |
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Current U.S.
Class: |
623/17.16 ;
623/17.15 |
Current CPC
Class: |
A61F 2002/30579
20130101; A61F 2220/0025 20130101; A61B 90/06 20160201; A61F
2002/3055 20130101; A61F 2002/4658 20130101; A61B 2017/0256
20130101; A61B 2090/061 20160201; A61F 2/4455 20130101; A61F 2/4611
20130101; A61F 2002/30556 20130101; A61F 2250/0009 20130101; A61F
2002/30507 20130101; A61B 17/7065 20130101; A61F 2/4657
20130101 |
Class at
Publication: |
623/17.16 ;
623/17.15 |
International
Class: |
A61F 2/44 20060101
A61F002/44 |
Claims
1. An apparatus, comprising: a spacer having a first spacer member
configured to engage an endplate of a first vertebra and a second
spacer member configured to engage an endplate of a second
vertebra, the second vertebra adjacent the first vertebra; and an
actuator having a first actuator member and a second actuator
member coupled to the first actuator member, the first actuator
member being matingly and movably coupled to the first spacer
member, the first actuator being matingly and movably coupled to
the second spacer member, the second actuator member being matingly
and movably coupled to the first spacer member, the second actuator
member being matingly and movably coupled to the second spacer
member, the actuator configured to move the spacer between a first
configuration and a second configuration, the first spacer member
being in contact with the second spacer member when the spacer is
in the first configuration, the first spacer member being spaced
apart from the second spacer member by a non-zero distance when the
spacer is in the second configuration.
2. The apparatus of claim 1, wherein: the first spacer member has a
first surface and a second surface, the second spacer member having
a first surface and a second surface; a first surface of the first
actuator member is matingly and movably coupled to the first
surface of the first spacer member, a second surface of the first
actuator is matingly and movably coupled to the first surface of
the second spacer member; and a first surface of the second
actuator member is matingly and movably coupled to the second
surface of the first spacer member, a second surface of the second
actuator member is matingly and movably coupled to the second
surface of the second spacer member.
3. The apparatus of claim 1, wherein the first spacer member and
the second spacer member collectively define an opening when the
spacer is in the second configuration.
4. The apparatus of claim 1, wherein a first surface of the first
actuator member is matingly and movably coupled to a first surface
of the first spacer member such that the first actuator member
remains in sliding contact with the first spacer member over a
range of motion.
5. The apparatus of claim 1, wherein a first surface of the first
actuator member is matingly and movably coupled to a first surface
of the first spacer member such that movement of the first spacer
member relative to first actuator member in direction substantially
normal to the first surface of the first actuator member is
limited.
6. The apparatus of claim 1, wherein: a first surface of the first
spacer member defines a groove having a trapezoidal cross-sectional
shape; and a first surface of the first actuator member includes a
protrusion having a trapezoidal cross-sectional shape, the
protrusion configured to be matingly received within the groove
such that the first surface of the first actuator member is
matingly and movably coupled to the first surface of the first
spacer member.
7. The apparatus of claim 1, wherein: a first surface of the first
spacer member defines a first groove, a second surface of the first
spacer member defines a second groove; a first surface of the first
actuator member has a protrusion configured to be matingly received
within the first groove, the first groove and the protrusion of the
first surface of the first actuator member collectively configured
to limit movement of the first spacer member relative to the first
actuator member in a direction substantially normal to the first
surface of the first actuator member; and a first surface of the
second actuator member has a protrusion configured to be matingly
received within the second groove, the second groove and the
protrusion of the first surface of the second actuator member
collectively configured to limit movement of the first spacer
member relative to the second actuator member in a direction
substantially normal to the first surface of the second actuator
member.
8. The apparatus of claim 1, wherein: a first surface of the first
spacer member defines a groove, a second surface of the first
spacer member defines a groove; a first surface of the second
spacer member defines a groove, a second surface of the second
spacer member defines a groove; a first surface of the first
actuator member has a protrusion configured to be matingly received
within the groove of the first surface of the first spacer member,
the groove of the first surface of the first spacer member and the
protrusion of the first surface of the first actuator member
collectively configured to maintain the first actuator member in
sliding contact with the first spacer member; a first surface of
the second actuator member has a protrusion configured to be
matingly received within the groove of the second surface of the
first spacer member, the groove of the second surface of the first
spacer member and the protrusion of the first surface of the second
actuator member collectively configured to maintain the second
actuator member in sliding contact with the first spacer member; a
second surface of the first actuator member has a protrusion
configured to be matingly received within the groove of the first
surface of the second spacer member, the groove of the first
surface of the second spacer member and the protrusion of the
second surface of the first actuator member collectively configured
to maintain the first actuator member in sliding contact with the
second spacer member; and a second surface of the second actuator
member has a protrusion configured to be matingly received within
the groove of the second surface of the second spacer member, the
groove of the second surface of the second spacer member and the
protrusion of the second surface of the second actuator member
collectively configured to maintain the second actuator member in
sliding contact with the second spacer member.
9. The apparatus of claim 1, wherein: the first spacer member has a
first surface and a second surface, an axis within a plane defined
by the first surface of the first spacer member is non-parallel to
and non-normal to a longitudinal axis of the spacer, an axis within
a plane defined by the second surface of the first spacer member is
non-parallel to and non-normal to the longitudinal axis; a first
surface of the first actuator member is matingly and movably
coupled to the first surface of the first spacer member; and a
first surface of the second actuator member is matingly and movably
coupled to the second surface of the first spacer member.
10. The apparatus of claim 1, wherein the first spacer member is
configured to translate relative to the second spacer member in a
direction substantially normal to a longitudinal axis of the spacer
when the spacer is moved from the first configuration to the second
configuration.
11. The apparatus of claim 1, wherein: the spacer has a first size
along a first axis substantially normal to a longitudinal axis of
the spacer and a second size along a second axis substantially
normal to the longitudinal axis and substantially normal to the
first axis, the first size when the spacer is in the second
configuration being greater than the first size when the spacer is
in the first configuration, the second size when the spacer is in
the second configuration being substantially equal to the second
size when the spacer is in the first configuration.
12. An apparatus, comprising: a spacer defining a longitudinal axis
and having a first spacer member and a second spacer member, the
first spacer member configured to engage an endplate of a first
vertebra, the first spacer member having a first surface and a
second surface, an axis within a plane defined by the first surface
of the first spacer member being non-parallel to and non-normal to
the longitudinal axis, an axis within a plane defined by the second
surface of the first spacer member being non-parallel to and
non-normal to the longitudinal axis, the second spacer member
configured to engage an endplate of a second vertebra, the second
vertebra adjacent the first vertebra, the second spacer member
having a first surface and a second surface, an axis within a plane
defined by the first surface of the second spacer member being
non-parallel to and non-normal to the longitudinal axis, an axis
within a plane defined by the second surface of the second spacer
member being non-parallel to and non-normal to the longitudinal
axis; and an actuator having a first actuator member and a second
actuator member movably coupled to the first actuator member, a
first surface of the first actuator member in contact with and
substantially parallel to the first surface of the first spacer
member, a second surface of the first actuator member in contact
with and substantially parallel to the first surface of the second
spacer member, a first surface of the second actuator member in
contact with and substantially parallel to the second surface of
the first spacer member, a second surface of the second actuator
member in contact with and substantially parallel to the second
surface of the second spacer member, the actuator configured to
move the spacer between a first configuration and a second
configuration, the first spacer member being in contact with the
second spacer member when the spacer is in the first configuration,
the first spacer member being spaced apart from the second spacer
member by a non-zero distance when the spacer is in the second
configuration.
13. The apparatus of claim 12, wherein the first spacer member and
the second spacer member collectively define an opening when the
spacer is in the second configuration.
14. The apparatus of claim 12, wherein the first surface of the
first actuator member is matingly coupled to the first surface of
the first spacer member.
15. The apparatus of claim 12, wherein the first surface of the
first actuator member is matingly coupled to the first surface of
the first spacer member such that the first actuator member remains
in sliding contact with the first spacer member over a range of
motion.
16. The apparatus of claim 12, wherein: the first surface of the
first spacer member defines a groove having a trapezoidal
cross-sectional shape; and the first surface of the first actuator
member includes a protrusion having a trapezoidal cross-sectional
shape, the protrusion configured to be matingly received within the
groove.
17. The apparatus of claim 12, wherein the first spacer member
translates relative to second spacer member in a direction
substantially normal to the longitudinal axis when the spacer is
moved from the first configuration to the second configuration.
18. The apparatus of claim 12, wherein: the spacer has a first size
along a first axis substantially normal to the longitudinal axis
and a second size along a second axis substantially normal to the
longitudinal axis and substantially normal to the first axis, the
first size when the spacer is in the second configuration being
greater than the first size when the spacer is in the first
configuration, the second size when the spacer is in the second
configuration being substantially equal to the second size when the
spacer is in the first configuration.
19. The apparatus of claim 12, wherein the first spacer member and
the second spacer member are collectively configured to distract
the endplate of the first vertebra and the endplate of the second
vertebra a distance of between approximately 8 millimeters and
approximately 16 millimeters.
20. The apparatus of claim 12, wherein the actuator is configured
to move the spacer between a plurality of configurations such that
the first spacer member can be spaced apart from the second spacer
member by a plurality of distances within between approximately 0
millimeters and approximately 4 millimeters.
21. An apparatus, comprising: a spacer defining a longitudinal axis
and having a first spacer member configured to engage an endplate
of a first vertebra and a second spacer member configured to engage
an endplate of a second vertebra, the second vertebra adjacent the
first vertebra, the first spacer member having a first surface and
a second surface, the second spacer member having a first surface
and a second surface; and an actuator having a first actuator
member and a second actuator member movably coupled to the first
actuator member, a first surface of the first actuator member being
matingly and movably coupled to the first surface of the first
spacer member, a second surface of the first actuator being
matingly and movably coupled to the first surface of the second
spacer member, a first surface of the second actuator member being
matingly and movably coupled to the second surface of the first
spacer member, a second surface of the second actuator member being
matingly and movably coupled to the second surface of the second
spacer member, the actuator configured to move the spacer between a
first configuration and a second configuration, the spacer having a
first size along a first axis substantially normal to the
longitudinal axis and a second size along a second axis
substantially normal to the longitudinal axis and substantially
normal to the first axis, the first size when the spacer is in the
second configuration being greater than the first size when the
spacer is in the first configuration, the second size when the
spacer is in the second configuration being substantially equal to
the second size when the spacer is in the first configuration.
22. The apparatus of claim 21, wherein the first spacer member and
the second spacer member collectively define an opening when the
spacer is in the second configuration.
23. The apparatus of claim 21, wherein the first surface of the
first actuator member is matingly and movably coupled to the first
surface of the first spacer member such that the first actuator
member remains in sliding contact with the first spacer member over
a range of motion.
24. The apparatus of claim 21, wherein: the first surface of the
first spacer member defines a groove having a trapezoidal
cross-sectional shape; and the first surface of the first actuator
member includes a protrusion having a trapezoidal cross-sectional
shape, the protrusion configured to be matingly received within the
groove.
25. The apparatus of claim 21, wherein the first spacer member is
configured to translate relative to second spacer member in a
direction substantially normal to the longitudinal axis when the
spacer is moved from the first configuration to the second
configuration.
26. The apparatus of claim 21, wherein: the first surface of the
first spacer member defines a groove, the second surface of the
first spacer member defines a groove; the first surface of the
second spacer member defines a groove, the second surface of the
second spacer member defines a groove; the first surface of the
first actuator member has a protrusion configured to be matingly
received within the groove of the first surface of the first spacer
member, the groove the first surface of the first spacer member and
the protrusion of the first surface of the first actuator member
collectively configured to maintain the first actuator member in
sliding contact with the first spacer member; the first surface of
the second actuator member has a protrusion configured to be
matingly received within the groove of the second surface of the
first spacer member, the groove of the second surface of the first
spacer member and the protrusion of the first surface of the second
actuator member collectively configured to maintain the second
actuator member in sliding contact with the first spacer member;
the second surface of the first actuator member has a protrusion
configured to be matingly received within the groove of the first
surface of the second spacer member, the groove of the first
surface of the second spacer member and the protrusion of the
second surface of the first actuator member collectively configured
to maintain the first actuator member in sliding contact with the
second spacer member; and the second surface of the second actuator
member has a protrusion configured to be matingly received within
the groove of the second surface of the second spacer member, the
groove of the second surface of the second spacer member and the
protrusion of the second surface of the second actuator member
collectively configured to maintain the second actuator member in
sliding contact with the second spacer member.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional
Application Ser. No. 61/025,991, entitled "Medical Implants and
Methods," filed Feb. 4, 2008, which is incorporated herein by
reference in its entirety.
[0002] This application is related to U.S. patent application
Attorney Docket No. KYPH-040/02US 305363-2271, entitled "Tools and
Methods for Insertion and Removal of Medical Implants,"
KYPH-040/03US 305363-2270, entitled "Medical Implants and Methods,"
and KYPH-040/04US 305363-2272, entitled "Spine Distraction Tools
and Methods of Use," each of which is filed herewith, and each of
which is incorporated herein by reference in its entirety.
BACKGROUND
[0003] The invention relates generally to the treatment of spinal
conditions, and more particularly, to the treatment of spinal
compression using percutaneous spinal implants for implantation
between adjacent spinous processes and/or percutaneous spinal
implants for implantation in a space associated with an
intervertebral disc.
[0004] Minimally-invasive procedures have been developed to provide
access to the space between adjacent spinous processes such that
major surgery is not required. Such known procedures, however, may
not be suitable in conditions where the spinous processes are
severely compressed. Moreover, such procedures typically involve
large or multiple incisions. Further, some of the known implants
configured to be inserted into a space associated with an
intervertebral disc are non-expandable and involve an invasive open
procedure.
[0005] Thus, a need exists for improvements in spinal implants for
implantation between adjacent spinous processes. Additionally, a
need exists for improvements in spinal implants for implantation in
a space associated with an intervertebral disc. A further need
exists for improvements in the tools used in placing spinal
implants.
SUMMARY
[0006] Spinal implants and methods are described herein. In some
embodiments, an apparatus includes a spacer and an actuator. The
spacer has a first spacer member configured to engage an endplate
of a first vertebra and a second spacer member configured to engage
an endplate of a second vertebra. The second vertebra can be
adjacent the first vertebra. The actuator has a first actuator
member and a second actuator member coupled to the first actuator
member. The first actuator member is matingly and movably coupled
to the first spacer member. Similarly, the first actuator is
matingly and movably coupled to the second spacer member. The
second actuator member is matingly and movably coupled to the first
spacer member. Similarly, the second actuator member is matingly
and movably coupled to the second spacer member. The actuator is
configured to move the spacer between a first configuration and a
second configuration. The first spacer member is in contact with
the second spacer member when the spacer is in the first
configuration. The first spacer member is spaced apart from the
second spacer member by a non-zero distance when the spacer is in
the second configuration.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] FIGS. 1 and 2 are schematic illustrations of an implant,
according to an embodiment in a first configuration and a second
configuration, respectively.
[0008] FIGS. 3 and 4 are schematic illustrations of an implant,
according to an embodiment in a first configuration and a second
configuration, respectively.
[0009] FIGS. 5 and 6 are schematic illustrations of an implant,
according to an embodiment in a first configuration and a second
configuration, respectively.
[0010] FIGS. 7 and 8 are perspective views of an implant, according
to an embodiment in a first configuration and a second
configuration, respectively.
[0011] FIG. 9 is a side view of the implant shown in FIG. 8 in the
second configuration.
[0012] FIG. 10 is a top view of the implant shown in FIG. 7 in the
first configuration.
[0013] FIG. 11 is a bottom view of the implant shown in FIG. 7 in
the first configuration.
[0014] FIG. 12 is a cross-sectional view of the implant shown in
FIGS. 7, 10 and 11 in the first configuration, taken along line X-X
in FIG. 10.
[0015] FIG. 13 is a cross-sectional view of the implant shown in
FIG. 12 in the second configuration.
[0016] FIG. 14 is a top perspective view of an implant according to
an embodiment, in a first configuration.
[0017] FIG. 15 is a side perspective view of the implant shown in
FIG. 14 in the first configuration.
[0018] FIG. 16 is a cross-sectional view of the implant shown in
FIGS. 14 and 15, taken along line X-X in FIG. 14.
[0019] FIG. 17 is a top perspective view of the implant shown in
FIG. 14 in a second configuration.
[0020] FIG. 18 is a side perspective view of the implant shown in
FIG. 14 in the second configuration.
[0021] FIG. 19 is a cross-sectional view of the implant shown in
FIGS. 17 and 18 in the second configuration.
[0022] FIGS. 20 and 21 are exploded views of the implant
illustrated in FIGS. 14-19.
[0023] FIG. 22 is a perspective view of an implant according to an
embodiment, in a first configuration.
[0024] FIG. 23 is a cross-sectional view of the implant shown in
FIG. 22 coupled to an insertion tool.
[0025] FIGS. 24 and 25 are perspective views of an implant,
according to an embodiment in a first configuration and a second
configuration, respectively.
[0026] FIG. 26 is a side view of the implant shown in FIG. 25 in
the second configuration.
[0027] FIG. 27 is a top view of the implant shown in FIG. 24 in the
first configuration.
[0028] FIG. 28 is a cross-sectional view of the implant shown in
FIG. 24, taken along line X-X in FIG. 24.
[0029] FIG. 29 is a cross-sectional view of the implant shown in
FIG. 27, taken along line X-X in FIG. 27.
[0030] FIG. 30 is a cross-sectional view of the implant shown in
FIG. 29 in the second configuration.
[0031] FIGS. 31 and 32 are perspective views of an implant,
according to an embodiment in a first configuration and a second
configuration, respectively.
[0032] FIG. 33 is a cross-sectional view of the implant shown in
FIG. 32 in the second configuration, taken along line X-X in FIG.
32.
[0033] FIG. 34 is a top view of the implant shown in FIG. 31 in the
first configuration.
[0034] FIG. 35 is a side view of the implant shown in FIG. 31 in
the first configuration.
[0035] FIG. 36 is a side view of the implant shown in FIG. 32 in
the second configuration.
[0036] FIG. 37 is a cross-sectional view of the implant shown in
FIG. 35, taken along line Y-Y in FIG. 35.
[0037] FIG. 38 is a cross-sectional view of the implant shown in
FIG. 34 in the first configuration, taken along line X-X in FIG.
34.
[0038] FIG. 39 is a cross-sectional view of the implant shown in
FIG. 38 in the second configuration.
[0039] FIG. 40 is a perspective view of an insertion member of the
implant shown in FIG. 31.
[0040] FIG. 41 is a perspective view of a support member of the
implant shown in FIG. 31.
[0041] FIG. 42 is a perspective view of a retention member of the
implant shown in FIG. 31.
[0042] FIG. 43 is a perspective view of a tool engagement member of
the implant shown in FIG. 31.
[0043] FIG. 44 is a perspective view of a cap of the implant shown
in FIG. 31.
[0044] FIGS. 45 and 46 are schematic illustrations of an implant,
according to an embodiment in a first configuration and a second
configuration, respectively.
[0045] FIGS. 47 and 48 are perspective views of an implant,
according to an embodiment in a first configuration and a second
configuration, respectively.
[0046] FIGS. 49 and 50 are perspective views of the implant shown
in FIG. 47 in a first configuration and a second configuration,
respectively.
[0047] FIG. 51 is a side view of the implant shown in FIG. 47 in
the first configuration.
[0048] FIG. 52 is a side view of the implant shown in FIG. 48 in
the second configuration.
[0049] FIG. 53 is a top view of the implant shown in FIG. 47 in the
first configuration.
[0050] FIG. 54 is a cross-sectional view of the implant shown in
FIG. 53 in the first configuration, taken along line X-X in FIG.
53.
[0051] FIG. 55 is a cross-sectional view of the implant shown in
FIG. 54 in the second configuration.
[0052] FIG. 56 is a cross-sectional view of the implant shown in
FIG. 51 in the first configuration, taken along line X-X in FIG.
51.
[0053] FIG. 57 is a perspective view of an insertion member of the
implant shown in FIG. 47.
[0054] FIG. 58 is a perspective view of a tool engagement member of
the implant shown in FIG. 47.
[0055] FIG. 59 is a perspective view of an intermediate member of
the implant shown in FIG. 47.
[0056] FIG. 60 is a perspective view of a central support member of
the implant shown in FIG. 47.
[0057] FIGS. 61-63 show various views of an implant according to an
embodiment.
[0058] FIG. 64 shows a connection portion of an implant according
to an embodiment.
[0059] FIG. 65 shows a connection portion of an implant according
to an embodiment.
[0060] FIG. 66 shows a connection portion of an implant according
to an embodiment.
DETAILED DESCRIPTION
[0061] In some embodiments, an apparatus includes a spacer, a
proximal retention member, a distal retention member, and an
actuator. The spacer defines a longitudinal axis and includes a
proximal surface and a distal surface opposite the proximal
surface. The spacer is configured to engage a first spinous process
and a second spinous process. The proximal retention member is
coupled to the spacer such that a portion of the proximal retention
member is in contact with the proximal surface of the spacer. The
distal retention member includes a first surface and a second
surface. The distal retention member is movably coupled to the
spacer such that the second surface is in contact with the distal
surface of the spacer. An axis within a plane defined by the first
surface of the distal retention member is non-parallel to and
non-normal to the longitudinal axis defined by the spacer. The
actuator is movably coupled to the spacer and is configured to move
relative to the spacer along the longitudinal axis defined by the
spacer. The actuator includes an actuation surface that is slidably
coupled to and substantially parallel to the first surface of the
distal retention member.
[0062] In some embodiments, an apparatus includes an interspinous
process implant. The interspinous process implant includes a
central body, a proximal retention member, and a distal retention
member, and defines a longitudinal axis. The central body includes
a proximal surface, a distal surface and an outer surface. The
proximal retention member has an engagement surface and an outer
surface. The proximal retention member is movably coupled to the
central body such that the engagement surface of the proximal
retention member is slidably coupled to the proximal surface of the
central body. The distal retention member has an engagement surface
and an outer surface. The distal retention member is movably
coupled to the central body such that the engagement surface of the
distal retention member is slidably coupled to the distal surface
of the central body. The interspinous process implant can be moved
between a first configuration and a second configuration. The outer
surface of the central body, the outer surface of the proximal
retention member and the outer surface of the distal retention
member are substantially aligned when the interspinous process
implant is in the first configuration. The outer surface of the
central body, a portion of the engagement surface of the proximal
retention member and a portion of the engagement surface of the
distal retention member collectively form a saddle when the
interspinous process implant is in the second configuration. The
saddle is configured to receive a spinous process.
[0063] In some embodiments, an apparatus includes a spacer, a
proximal retention member, a distal retention member, and an
actuator. The spacer has a proximal surface and a distal surface
opposite the proximal surface, and defines a longitudinal axis. The
spacer is configured to engage a spinous process. The proximal
retention member is coupled to the spacer such that a portion of
the proximal retention member is in contact with the proximal
surface of the spacer. The distal retention member includes a
surface that defines a dovetail groove. The distal retention member
is movably coupled to the spacer such that a portion of the distal
retention member is in contact with the distal surface of the
spacer. The actuator is movably coupled to the spacer and has an
actuation surface having a dovetail protrusion. The dovetail
protrusion of the actuation surface of the actuator is configured
to be matingly received within the dovetail groove defined by the
surface of the distal retention member.
[0064] In some embodiments, an apparatus includes a spacer, a first
retention member, a second retention member and an actuator. The
spacer includes a surface and defines a longitudinal axis. The
spacer is configured to engage a spinous process. The first
retention member has a first surface and a second surface. The
first retention member is movably coupled to the spacer such that
the second surface of the first retention member is slidably
coupled to the surface of the spacer. An axis within a plane
defined by the first surface of the first retention member is
non-parallel to and non-normal to the longitudinal axis defined by
the spacer. The second retention member includes a first surface
and a second surface. The second retention member is movably
coupled to the spacer such that the second surface of the second
retention member is slidably coupled to the surface of the spacer.
The actuator is movably coupled to the spacer and includes a
tapered portion having a first actuation surface and a second
actuation surface. The first actuation surface is slidably coupled
to and substantially parallel to the first surface of the first
retention member. The second actuation surface is slidably coupled
to and substantially parallel to the first surface of the second
retention member.
[0065] In some embodiments, an apparatus includes a spacer, a
retention assembly and an actuator. The spacer is configured to
engage adjacent spinous processes. The spacer has a first size
along an axis normal to a longitudinal axis of the spacer when in a
first configuration and a second size along the axis normal to the
longitudinal axis when in a second configuration. The second size
of the spacer is greater than the first size of the spacer. The
retention assembly includes a first surface and a second surface.
The retention assembly has a first size along the axis normal to
the longitudinal axis of the spacer when in a first configuration
and a second size along the axis normal to the longitudinal axis
when in a second configuration. The second size of the retention
assembly is greater than the first size of the retention assembly.
The retention assembly is movably coupled to the spacer such that
the second surface of the retention assembly is in contact with a
surface of the spacer. An axis within a plane defined by the first
surface of the retention assembly is non-parallel to and non-normal
to the longitudinal axis of the spacer. The actuator is movably
coupled to the spacer and includes an actuation surface slidably
coupled to and substantially parallel to the first surface of the
retention assembly. The actuator is configured to move the
retention assembly between its first configuration and its second
configuration. Further, the actuator is configured to move the
spacer between its first configuration and its second
configuration.
[0066] As used in this specification and the appended claims, the
singular forms "a," "an" and "the" include plural referents unless
the context clearly dictates otherwise. Thus, for example, the term
"a member" is intended to mean a single member or a combination of
members, "a material" is intended to mean one or more materials, or
a combination thereof. Furthermore, the words "proximal" and
"distal" refer to direction closer to and away from, respectively,
an operator (e.g., surgeon, physician, nurse, technician, etc.) who
would insert the medical device into the patient, with the tip-end
(i.e., distal end) of the device inserted inside a patient's body
first. Thus, for example, the implant end first inserted inside the
patient's body would be the distal end of the implant, while the
implant end to last enter the patient's body would be the proximal
end of the implant.
[0067] The term "parallel" is used herein to describe a
relationship between two geometric constructions (e.g., two lines,
two planes, a line and a plane, two curved surfaces, a line and a
curved surface or the like) in which the two geometric
constructions are substantially non-intersecting as they extend
substantially to infinity. For example, as used herein, a line is
said to be parallel to a curved surface when the line and the
curved surface do not intersect as they extend to infinity.
Similarly, when a planar surface (i.e., a two-dimensional surface)
is said to be parallel to a line, every point along the line is
spaced apart from the nearest portion of the surface by a
substantially equal distance. Two geometric constructions are
described herein as being "parallel" or "substantially parallel" to
each other when they are nominally parallel to each other, such as
for example, when they are parallel to each other within a
tolerance. Such tolerances can include, for example, manufacturing
tolerances, measurement tolerances or the like.
[0068] The term "normal" is used herein to describe a relationship
between two geometric constructions (e.g., two lines, two planes, a
line and a plane, two curved surfaces, a line and a curved surface
or the like) in which the two geometric constructions intersect at
an angle of approximately 90 degrees within at least one plane. For
example, as used herein, a line is said to be normal to a curved
surface when the line and an axis tangent to the curved surface
intersect at an angle of approximately 90 degrees within a plane.
Two geometric constructions are described herein as being "normal"
or "substantially normal" to each other when they are nominally
normal to each other, such as for example, when they are normal to
each other within a tolerance. Such tolerances can include, for
example, manufacturing tolerances, measurement tolerances or the
like.
[0069] It should be understood that the references to geometric
constructions are for purposes of discussion and illustration. The
actual structures may differ from geometric ideal due to tolerances
and/or other minor deviations from the geometric ideal.
[0070] FIGS. 1 and 2 are schematic illustrations of an implant 100,
according to an embodiment, in a first configuration and a second
configuration, respectively. Implant 100 includes a spacer 140, a
proximal retention member 160, a distal retention member 120, and
an actuator 111. The spacer 140 of the implant 100 includes a
proximal surface 142, a distal surface 143, and an outer surface
141, and defines a longitudinal axis A.sub.L. At least a portion of
the implant 100 is configured to be disposed in a space between a
first spinous process SP1 and a second spinous process SP2 such
that the spacer 140 of the implant 100 engages the first spinous
process SP1 and the second spinous process SP2 during spinal
extension, either directly or through surrounding tissue. Said
another way, at least during spinal extension, the outer surface
141 of the spacer 140 is configured to directly engage and/or
contact the spinous processes SP1, SP2 and/or the bodily tissue
surrounding the spinous processes SP1, SP2 without any intervening
structure associated with the implant 100. In some embodiments, for
example, a portion of the spacer 140 is disposed within an opening
defined in the interspinous ligament (not shown). In this manner,
the spacer 140 can contact the spinous processes SP1, SP2 through
the interspinous ligament. For purposes of clarity, however, the
tissue surrounding the spinous processes SP1, SP2 is not
illustrated.
[0071] The proximal retention member 160 of the implant 100 is
coupled to the spacer 140 such that at least a portion of the
proximal retention member 160 is adjacent the proximal surface 142
of the spacer 140. In some embodiments, a portion of the proximal
retention member 160 can be in contact with the proximal surface
142 of the spacer 140. In other embodiments, the proximal retention
member 160 can be spaced apart from the proximal surface 142 of the
spacer 140. In some embodiments, the proximal retention member 160
can be movably coupled to the spacer 140. In other embodiments, the
proximal retention member 160 can be removably coupled to the
spacer 140.
[0072] The distal retention member 120 of the implant 100 is
movably coupled to the spacer 140, and includes a first surface
122, a second surface 123, and an outer surface 121. An axis
A.sub.p within a plane defined by the first surface 122 of the
distal retention member 120 is non-parallel to and non-normal to
the longitudinal axis A.sub.L. Said another way, the first surface
122 of the distal retention member 120 is angularly offset from the
longitudinal axis A.sub.L by an angle .theta..sub.1. The angle
.theta..sub.1, which is defined by the first surface 122 of the
distal retention member 120 and the longitudinal axis A.sub.L, is
supplementary to the angle .theta..sub.2, which is defined by the
actuation surface 116 of the actuator 111 and the longitudinal axis
A.sub.L, as further described herein. Moreover, the first surface
122 of the distal retention member 120 is substantially parallel to
the actuation surface 116 of the actuator 111.
[0073] The distal retention member 120 is coupled to the spacer 140
such that the second surface 123 of the distal retention member 120
is in contact with the distal surface 143 of the spacer 140. As
shown in FIGS. 1 and 2, the second surface 123 of the distal
retention member 120 is substantially normal to the longitudinal
axis A.sub.L. Moreover, the second surface 123 of the distal
retention member 120 is substantially parallel to the distal
surface 143 of the spacer 140. Said another way, the second surface
123 of the distal retention member 120 defines an angle with
respect to the longitudinal axis A.sub.L that is supplementary to
an angle defined by the distal surface 143 of the spacer 140 with
respect to the longitudinal axis A.sub.L.
[0074] The actuator 111 of the implant 100 is movably coupled to
the spacer 140, and includes an actuation surface 116. The
actuation surface 116 is slidably coupled to and substantially
parallel to the first surface 122 of the distal retention member
120. Said another way, the axis A'.sub.P is within a plane defined
by the actuation surface 116 of the actuator 111. As shown in FIG.
1, the actuation surface 116 of the actuator 111 is angularly
offset from the longitudinal axis A.sub.L by an angle
.theta..sub.2. The angle .theta..sub.2, which is defined by the
actuation surface 116 of the actuator 111 and the longitudinal axis
A.sub.L, is supplementary to the angle .theta..sub.1, as described
above.
[0075] As shown in FIGS. 1 and 2, the implant 100 is movable
between a first configuration (FIG. 1) and a second configuration
(FIG. 2). When the implant 100 is in the first configuration, the
actuator 111 is spaced apart from the distal surface 143 of the
spacer 140 along the longitudinal axis A.sub.L by a non-zero
distance D1. When the implant 100 is in the first configuration,
the outer surface 121 of the distal retention member 120 is
substantially aligned with the outer surface 141 of the spacer 140.
Said another way, the outer surface 121 of the distal retention
member 140 and the outer surface 141 of the spacer 140 form a
substantially continuous surface. Said yet another way, the outer
surface 121 of the distal retention member 120 is substantially
flush with the outer surface 141 of the spacer 140. Said still
another way, the second surface 123 of the distal retention member
120 and the distal surface 143 of the spacer 140 are aligned.
[0076] To move the implant 100 to the second configuration, the
actuator 111 is moved along the longitudinal axis A.sub.L in the
direction shown by the arrow AAA in FIG. 2. Movement of the
actuator 111 causes the actuation surface 116 of the actuator 111
to exert an axial force on the first surface 122 of the distal
retention member 120. Because the actuation surface 116 of the
actuator 111 is at an angle .theta..sub.2 with respect to the
longitudinal axis A.sub.L, a component of the axial force
transmitted via the actuation surface 116 to the first surface 122
of the distal retention member 120 has a direction as shown by the
arrow BBB in FIG. 2. Said another way, a component of the force
exerted by the actuator 111 on the distal retention member 120 has
a direction that is substantially normal to the longitudinal axis
A.sub.L. Accordingly, the force exerted by the actuator 111 on the
distal retention member 120 causes the first surface 122 of the
distal retention member 120 to slide on the actuation surface 116
of the actuator 111, and causes the distal retention member 120 to
move in the direction shown by the arrow BBB in FIG. 2.
[0077] As shown in FIG. 2, when the implant 100 is in the second
configuration, the actuator 111 is spaced apart from the distal
surface 143 of the spacer 140 along the longitudinal axis A.sub.L
by a non-zero distance D2, which is less than the distance D1.
Although shown in FIG. 2 as being spaced apart by the distance D2,
in other embodiments, the actuator 111 can be in contact with the
distal surface 143 of the spacer 140 when the implant 100 is in the
second configuration. In such embodiments, after the actuator 111
moves a predetermined distance along the longitudinal axis A.sub.L,
the actuator 111 can contact the distal surface 143 of the spacer
140, limiting the range of motion of the actuator 111 relative to
the spacer 140.
[0078] When the implant 100 is in the second configuration, the
distal retention member 120 is offset from the spacer 140 in a
direction substantially normal to the longitudinal axis A.sub.L, as
shown by the arrow BBB in FIG. 2. Said another way, the outer
surface 121 of the distal retention member 120 is not aligned with
the outer surface 141 of the spacer 140 and is discontinuous with
the outer surface 141 of the spacer 140. Said yet another way, the
outer surface 121 of the distal retention member 120 is spaced
apart from the outer surface 141 of the spacer 140 by a non-zero
distance D3. In this manner, the distal retention member 120, the
proximal retention member 160 and the spacer 140 form a saddle, as
further described herein.
[0079] The angle .theta..sub.1 of the first surface 122 of the
distal retention member 120 and the angle .theta..sub.2 of the
actuation surface 116 of the actuator 120 can be any suitable
angle. The value of the angles .theta..sub.1 and .theta..sub.2 can
influence the force to move the implant 100 from the first
configuration to the second configuration and/or the axial distance
through which the actuator 111 travels when the implant 100 is
moved from the first configuration to the second configuration.
More particularly, if the angle .theta..sub.1 is close to 180
degrees (e.g., between 165 and 180 degrees) and the angle
.theta..sub.2 is close to 0 degrees (e.g., between 0 and 15
degrees), the force to move the implant 100 from the first
configuration to the second configuration will be less than the
force needed if the angle .theta..sub.1 and the angle .theta..sub.2
are both close to 90 degrees. Said another way, when the first
surface 122 of the distal retention member 120 and the actuation
surface 116 of the actuator 111 are close to being parallel to the
longitudinal axis A.sub.L, less force is needed to move the implant
100 to the second configuration than when the first surface 122 of
the distal retention member 120 and the actuation surface 116 of
the actuator 111 are close to being normal to the longitudinal
axis. If the angle .theta..sub.1 is close to 180 degrees and the
angle .theta..sub.2 is close to 0 degrees, however, the distance
the actuator 111 travels along the longitudinal axis A.sub.L to
move the implant 100 from the first configuration to the second
configuration to achieve the desired offset of the retention member
120 (e.g., D3), will be greater than the distance the actuator 111
travels if the angle .theta..sub.1 and the angle .theta..sub.2 are
both close to 90 degrees.
[0080] In use, the implant 100 can be inserted between a first
spinous process SP1 and a second spinous process SP2 when the
implant 100 is in the first configuration (see e.g., FIG. 1). For
example, a medical practitioner can insert the implant 100
percutaneously into a body of a patient. In some embodiments, the
implant 100 can be inserted percutaneously via a cannula. In some
embodiments, a tool, such as those described in U.S. patent
application Attorney Docket No. KYPH-040/02US 305363-2272 entitled
"Tools and Methods for Insertion and Removal of Medical Implants,"
which is incorporated herein by reference in its entirety, can be
used to insert the implant 100 into a body of a patient.
[0081] After the implant 100 is between the first spinous process
SP1 and the second spinous process SP2, the implant 100 can be
moved from the first configuration to the second configuration (see
e.g., FIG. 2). In some embodiments, the implant 100 can be actuated
using a tool (not shown) configured to move the actuator 111
relative to the spacer 140 when the implant is within the body.
Such tools can include, for example, those tools described in U.S.
patent application Attorney Docket No. KYPH-040/02US 305363-2272
entitled "Tools and Methods for Insertion and Removal of Medical
Implants," which is incorporated herein by reference in its
entirety. As stated above, when the implant 100 is in the second
configuration, the distal retention member 120, the proximal
retention member 160 and the spacer 140 form a saddle, within which
the first spinous process SP1 is disposed. In this manner, when the
implant 100 is in the second configuration, the distal retention
member 120 and the proximal retention member 160 can collectively
limit movement of the spacer 140 with respect to the first spinous
process SP1 along the longitudinal axis A.sub.L.
[0082] A medical practitioner can remove the implant 100 from
and/or reposition the implant 100 within the body. To remove from
and/or reposition the implant 100 within the body, the implant 100
can be moved from the second configuration to the first
configuration. This can be done by moving the actuator 111 in a
direction opposite the direction shown by the arrow AAA in FIG. 2.
This causes the implant 100 to return to the first configuration.
After the implant 100 is in the first configuration, the medical
practitioner can remove the implant 100 from and/or reposition the
implant 100 within the body.
[0083] Although the distal surface 143 of the spacer 140 is shown
and described as being substantially normal to the longitudinal
axis A.sub.L, in some embodiments, the distal surface 143 of the
spacer 140 can be angularly offset from the longitudinal axis
A.sub.L. Said another way, in some embodiments, the proximal
surface 142 of the spacer 140 and/or the distal surface 143 of the
spacer 140 can define an angle with respect to the longitudinal
axis A.sub.L that is not ninety degrees. For example, in some
embodiments, the distal surface 143 of the spacer 140 can define an
obtuse angle with respect to the longitudinal axis A.sub.L, and the
second surface 123 of the distal retention member 120 can define a
supplementary acute angle with respect to the longitudinal axis
A.sub.L. In other embodiments, the distal surface 143 of the spacer
140 can define an acute angle with respect to the longitudinal axis
A.sub.L, and the second surface 123 of the distal retention member
120 can define a supplementary obtuse angle with respect to the
longitudinal axis A.sub.L. Such a non-normal arrangement of angles
causes the distal retention member 120 to move in a direction
substantially parallel to the distal surface 143 of the spacer 140
when the implant 100 is moved from the first configuration to the
second configuration. Thus, the angle of the distal surface 143 of
the spacer 140 affects the direction of movement of the distal
retention member 120 when the implant 100 moves from the first
configuration to the second configuration. In this manner, the
distal retention member 120 can be configured to move in a
direction non-normal to the longitudinal axis A.sub.L. For example,
in some embodiments, the distal retention member 120 can move
distally (i.e., away from the spinous process SP1) relative to the
spacer 111 when the implant 100 moves from the first configuration
to the second configuration. In other embodiments, the distal
retention member 120 can move proximally (i.e., towards the spinous
process SP1) relative to the spacer 111 when the implant 100 moves
from the first configuration to the second configuration. The
proximal movement of the distal retention member 120 can be used,
for example, to cause the distal retention member 120 to contact
the spinous process SP1 when in the second configuration.
[0084] Although the outer surface 121 of the distal retention
member 120 is shown and described as being substantially aligned
with the outer surface 141 of the spacer 140 when the implant 100
is in the first configuration, in some embodiments, the outer
surface 121 of the distal retention member 120 can be offset from
the outer surface 141 of the spacer when the implant 100 is in the
first configuration. Said another way, in some embodiments, the
outer surface 121 of the distal retention member 120 can be
discontinuous with the outer surface 141 of the spacer 140 when the
implant 100 is in the first configuration. Said yet another way, in
some embodiments, the outer surface 121 of the distal retention
member 120 can be spaced apart from the outer surface 141 of the
spacer 140 by a distance different than distance D3 (the distance
the outer surface 121 of the distal retention member 120 is spaced
apart from the outer surface 141 of the spacer 140 when the implant
100 is in the second configuration) when the implant 100 is in the
first configuration.
[0085] FIGS. 3 and 4 are schematic illustrations of an implant 200,
according to an embodiment. The implant 200 includes a central body
240, a proximal retention member 260, and a distal retention member
220, and defines a longitudinal axis A.sub.L. The central body 240
includes a proximal surface 242, a distal surface 243 and an outer
surface 241. At least a portion of the central body 240 of implant
200 is configured to be disposed in a space between a first spinous
process SP1 and a second spinous process SP2 such that the outer
surface 241 of the central body 240 can engage a first spinous
process SP1 and a second spinous process SP2, either directly or
through surrounding tissue. Said another way, at least during
spinal extension, the outer surface 241 of the central body 240 is
configured to directly engage and/or contact the spinous processes
SP1, SP2 and/or the bodily tissue surrounding the spinous processes
SP1, SP2 without any intervening structure associated with the
implant 200. In some embodiments, for example, a portion of the
central body 240 is disposed within an opening defined in the
interspinous ligament (not shown). In this manner, the central body
240 can contact the spinous processes SP1, SP2 through the
interspinous ligament. For purposes of clarity, however, the tissue
surrounding the spinous processes SP1, SP2 is not illustrated.
[0086] The proximal retention member 260 of the implant 200
includes an outer surface 261 and an engagement surface 263. The
engagement surface 263 is substantially normal to the longitudinal
axis A.sub.L and is slidably coupled to the proximal surface 242 of
the central body 240. Accordingly, the proximal retention member
260 can translate relative to the central body 240 between a first
position and a second position corresponding to a first
configuration of the implant 200 and a second configuration of the
implant 200, respectively, as described in further detail herein.
The engagement surface 263 of the proximal retention member 260 is
substantially parallel to the proximal surface 242 of the central
body 240. Said another way, the angle that the engagement surface
263 defines with respect to the longitudinal axis A.sub.L is
supplementary to the angle defined by the proximal surface 242 of
the central body 240 with respect to the longitudinal axis
A.sub.L.
[0087] The distal retention member 220 of the implant 200 includes
an outer surface 221 and an engagement surface 223. The engagement
surface 223 is substantially normal to the longitudinal axis
A.sub.L and is slidably coupled to the distal surface 243 of the
central body 240. Accordingly, the distal retention member 220 can
translate relative to the central body 240 between a first position
and a second position corresponding to the first configuration of
the implant 200 and the second configuration of the implant 200,
respectively, as described in further detail herein. The engagement
surface 223 of the distal retention member 220 is substantially
parallel to the distal surface 243 of the central body 240. Said
another way, the angle that the engagement surface 223 defines with
respect to the longitudinal axis A.sub.L is supplementary to the
angle defined by the distal surface 243 of the central body 240
with respect to the longitudinal axis A.sub.L.
[0088] As shown in FIGS. 3 and 4, the implant 200 is movable
between a first configuration (FIG. 3) and a second configuration
(FIG. 4). When the implant 200 is in the first configuration, the
outer surface 221 of the distal retention member 220, the outer
surface 261 of the proximal retention member 260 and the outer
surface 241 of the central body 240 are substantially aligned. Said
another way, the outer surface 221 of the distal retention member
220, the outer surface 261 of the proximal retention member 260 and
the outer surface 241 of the central body 240 form a substantially
continuous surface. Said yet another way, the outer surface 221 of
the distal retention member 220 and the outer surface 261 of the
proximal retention member 260 are flush with the outer surface 241
of the central body 240.
[0089] To move the implant 200 to the second configuration, the
proximal retention member 260 and the distal retention member 220
are moved from their first positions to their second positions by
moving them in the direction shown by the arrow CCC in FIG. 4. More
particularly, the proximal retention member 260 and the distal
retention member 220 translate relative to the central body 240.
Said another way, the proximal retention member 260 and the distal
retention member 220 move in a direction substantially normal to
the longitudinal axis A.sub.L. Said yet another way, the proximal
retention member 260 and the distal retention member 220 slide
along the proximal surface 242 of the central body 240 and the
distal surface 243 of the central body 240, respectively. In some
embodiments, the proximal retention member 260 and the distal
retention member 220 can be moved, for example, by a tool
configured to engage the proximal retention member 260 and/or the
distal retention member 220. In some embodiments, the implant 200
can include actuators, similar to actuator 111 of the implant 100,
to move the proximal retention member 260 and the distal retention
member 220 between their respective first positions and their
second positions.
[0090] When the implant 200 is in the second configuration, the
distal retention member 220 and the proximal retention member 260
are offset from the central body 240 in a direction normal to the
longitudinal axis A.sub.L. Said another way, at least a portion of
the outer surface 221 of the distal retention member 220 and at
least a portion of the outer surface 261 of the proximal retention
member 260 are spaced apart from the outer surface 241 of the
central body 240 by a distance D4. In this manner, the distal
retention member 220, the proximal retention member 260 and the
central member 240 form a saddle, as further described herein.
[0091] In use, the implant 200 can be inserted between a first
spinous process SP1 and a second spinous process SP2 when the
implant 200 is in the first configuration (see e.g., FIG. 3). For
example, a medical practitioner can insert the implant 200
percutaneously (e.g., through a cannula, over a guide wire, or the
like) into a body of a patient. In some embodiments, a tool, such
as those described in U.S. patent application Attorney Docket No.
KYPH-040/02US 305363-2272 entitled "Tools and Methods for insertion
and Removal of Medical Implants," which is incorporated herein by
reference in its entirety, can be used to insert the implant 200
into a body of a patient.
[0092] After the implant 200 is between the first spinous process
SP1 and the second spinous process SP2, the implant 200 can be
moved from the first configuration to the second configuration (see
e.g., FIG. 4). In some embodiments, the implant 200 can be actuated
using a tool (not shown) configured to move the distal retention
member 220 and the proximal retention member 260 relative to the
central body 240 when the implant 200 is within the body. Such
tools can be configured to maintain the central body 240 in a fixed
position while exerting a force on the distal retention member 220
and/or the proximal retention member 260. Such tools can include,
for example, those tools described in U.S. patent application
Attorney Docket No. KYPH-040/02US 305363-2272 entitled "Tools and
Methods for Insertion and Removal of Medical Implants," which is
incorporated herein by reference in its entirety. As stated above,
when the implant 200 is in the second configuration, the distal
retention member 220, the proximal retention member 260 and the
central body 240 form a saddle, within which the first spinous
process SP1 is disposed. In this manner, when the implant 200 is in
the second configuration the distal retention member 220 and the
proximal retention member 260 can collectively limit movement of
the central body 240 with respect to the first spinous process
SP1.
[0093] A medical practitioner can remove from and/or reposition the
implant 200 within the body multiple times. To remove from and/or
reposition the implant 200 within the body, the implant 200 can be
moved from the second configuration to the first configuration.
This can be done by moving the distal retention member 220 and the
proximal retention member 260 to their first positions and thus the
implant 200 to its first configuration. After the implant 200 is in
the first configuration, the medical practitioner can remove from
and/or reposition the implant 200 within the body.
[0094] In some embodiments, the distal retention member 220 can
include a tapered portion to facilitate insertion of the implant
200 into the body. More particularly, the tapered portion can
distract, dilate and/or pierce a bodily tissue. In some
embodiments, for example, the tapered portion can pierce a bodily
tissue, such as the interspinous ligament, when the implant 200 is
inserted into the body. In some embodiments, the tapered portion
can dilate a bodily tissue, such as the interspinous ligament, when
the implant 200 is inserted into the body. In some embodiments, the
tapered portion can distract a space between adjacent spinous
processes when the implant 200 is inserted into the body.
[0095] FIGS. 5 and 6 are schematic illustrations of an implant 300,
according to an embodiment, in a first configuration and a second
configuration, respectively. The implant 300 includes a spacer 340,
a first retention member 320, a second retention member 330 and an
actuator 311. The spacer 340 includes a side surface 343, an outer
surface 341, and defines a longitudinal axis A.sub.L. At least a
portion of the spacer 340 of implant 300 is configured to be
disposed in a space between a first spinous process SP1 and a
second spinous process SP2 such that the outer surface 341 of the
spacer 340 can engage a first spinous process SP1 and a second
spinous process SP2, either directly or through surrounding tissue.
Said another way, at least during spinal extension, the outer
surface 341 of the spacer 340 is configured to directly engage
and/or contact the spinous processes SP1, SP2 and/or the bodily
tissue surrounding the spinous processes SP1, SP2 without any
intervening structure associated with the implant 300. In some
embodiments, for example, a portion of the spacer 340 is disposed
within an opening defined in the interspinous ligament (not shown).
In this manner, the spacer 340 can contact the spinous processes
SP1, SP2 through the interspinous ligament. For purposes of
clarity, however, the tissue surrounding the spinous processes SP1,
SP2 is not illustrated.
[0096] The first retention member 320 of the implant 300 includes a
first surface 322, a second surface 323, and an outer surface 321.
The second surface 323 of the first retention member 320 is
slidably coupled to the side surface 343 of the spacer 340. In this
manner, the first retention member 320 can move with respect to the
spacer 340. The second surface 323 of the first retention member
320 is substantially normal to the longitudinal axis A.sub.L and is
substantially parallel to the side surface 343 of the spacer 340.
Said another way, the second surface 323 of the first retention
member 320 has an angle with respect to the longitudinal axis
A.sub.L that is supplementary to the angle defined by the side
surface 343 of the spacer 340 and the longitudinal axis
A.sub.L.
[0097] The first surface 322 of the first retention member 320 is
substantially parallel to the first actuation surface 316 of the
actuator 311. An axis A.sub.P1 defined by a plane within the first
surface 322 of the first retention member 320 is non-parallel to
and non-normal to the longitudinal axis A.sub.L. Said another way,
the first surface 322 of the first retention member 320 is
angularly offset from the longitudinal axis A.sub.L by an angle
.theta..sub.3. The angle .theta..sub.3, which is defined by the
first surface 322 of the first retention member 320 and the
longitudinal axis A.sub.L, is supplementary to the angle
.theta..sub.4 defined by the first actuation surface 316 of the
actuator 311 and the longitudinal axis A.sub.L.
[0098] The second retention member 330 of the implant 300 includes
a first surface 332, a second surface 333, and an outer surface
331. The second surface 333 of the second retention member 330 is
slidably coupled to the side surface 343 of the spacer 340. In this
manner, the second retention member 330 can move with respect to
the spacer 340. The second surface 333 of the second retention
member 330 is substantially normal to the longitudinal axis A.sub.L
and is substantially parallel to the side surface 343 of the spacer
340. Said another way, the second surface 333 of the second
retention member 330 has an angle with respect to the longitudinal
axis A.sub.L that is supplementary to the angle defined by the side
surface 343 of the spacer 340 and the longitudinal axis
A.sub.L.
[0099] The first surface 332 of the second retention member 330 is
substantially parallel to the second actuation surface 317 of the
actuator 311. An axis A.sub.P2 within a plane defined by the first
surface 332 of the second retention member 330 is non-parallel to
and non-normal to the longitudinal axis A.sub.L. Said another way,
the first surface 332 of the second retention member 330 is
angularly offset from the longitudinal axis A.sub.L by an angle
.theta..sub.5. The angle .theta..sub.5, which is defined by the
first surface 332 of the second retention member 330 and the
longitudinal axis A.sub.L, is supplementary to the angle
.theta..sub.6 defined by the second actuation surface 317 of the
actuator 311 and the longitudinal axis A.sub.L.
[0100] The actuator 311 of the implant 300 includes a tapered
portion 305 having a first actuation surface 316 and a second
actuation surface 317. As stated above, the first actuation surface
316 is substantially parallel to the first surface 322 of the first
retention member 320. Similarly, the second actuation surface 317
is substantially parallel to the first surface 332 of the second
retention member 330. As described above, the angle .theta..sub.4,
which is defined by the first actuation surface 316 of the actuator
311 and the longitudinal axis A.sub.L, is supplementary to the
angle .theta..sub.3, which is defined by the first surface 322 of
the first retention member 320 and the longitudinal axis A.sub.L.
Similarly, the angle .theta..sub.6, which is defined by the second
actuation surface 317 of the actuator 311 and the longitudinal axis
A.sub.L, is supplementary to the angle .theta..sub.5, which is
defined by the first surface 332 of the second retention member 330
and the longitudinal axis A.sub.L.
[0101] As shown in FIGS. 5 and 6, the implant 300 is movable
between a first configuration (FIG. 5) and a second configuration
(FIG. 6). When the implant 300 is in the first configuration, the
actuator 311 is spaced apart from the side surface 343 of the
spacer 340 along the longitudinal axis A.sub.L by a distance D5.
When the implant 300 is in the first configuration, the outer
surface 321 of the first retention member 320 and the outer surface
331 of the second retention member 330 are substantially aligned
with the outer surface 341 of the spacer 340. Said another way, the
outer surface 321 of the first retention member 320 and the outer
surface 341 of the spacer 340 form a substantially continuous
surface. Similarly, the outer surface 331 of the second retention
member 330 and the outer surface 341 of the spacer 340 form a
substantially continuous surface. Said yet another way, the outer
surface 321 of the first retention member 320 is substantially
flush with the outer surface 341 of the spacer 340. Similarly, the
outer surface 331 of the second retention member 330 is
substantially flush with the outer surface 341 of the spacer 340.
Said still another way, the second surface 323 of the first
retention member 320 and the second surface 333 of the second
retention member 330 are aligned with the side surface 343 of the
spacer 340.
[0102] To move the implant 300 to the second configuration, the
actuator 311 is moved along the longitudinal axis A.sub.L in the
direction shown by the arrow DDD in FIG. 6. Movement of the
actuator 311 causes the first actuation surface 316 of the actuator
311 to exert an axial force on the first surface 322 of the first
retention member 320. As described above, because the first
actuation surface 316 of the actuator 311 is at an angle
.theta..sub.4 with respect to the longitudinal axis A.sub.L, a
component of the axial force transmitted via the first actuation
surface 316 to the first surface 322 of the first retention member
320 has a direction as shown by the arrow EEE in FIG. 6.
Accordingly, the force exerted by the actuator 311 on the first
retention member 320 causes the first surface 322 of the first
retention member 320 to slide on the first actuation surface 316 of
the actuator 311, and causes the first retention member 320 to move
in the direction shown by the arrow EEE in FIG. 6.
[0103] Similarly, movement of the actuator 311 in the direction
shown by the arrow DDD in FIG. 6 causes the second actuation
surface 317 of the actuator to exert an axial force on the first
surface 332 of the second retention member 330. Because the second
actuation surface 317 of the actuator 311 is at an acute angle
.theta..sub.6 with respect to the longitudinal axis A.sub.L, a
component of the axial force transmitted via the second actuation
surface 317 to the first surface 332 of the second retention member
330 has a direction as shown by the arrow FFF in FIG. 6.
Accordingly, the force exerted by the actuator 311 on the second
retention member 330 causes the first surface 332 of the second
retention member 330 to slide on the second actuation surface 317
of the actuator 311, and causes the second retention member 330 to
move in the direction shown by the arrow FFF in FIG. 6. Similar to
implant 100 described above, the values of the angles
.theta..sub.3, .theta..sub.4, .theta..sub.5, .theta..sub.6,
influence the force to move the implant 300 from the first
configuration to the second configuration and the distance the
actuator 311 travels to move the implant 300 from the first
configuration to the second configuration.
[0104] As shown in FIG. 6, when the implant 300 is in the second
configuration, the actuator 311 is spaced apart from the side
surface 343 of the spacer 340 along the longitudinal axis A.sub.L
by a distance D6, which is less than D5. Although shown in FIG. 6
as being spaced apart by the distance D6, in other embodiments, the
actuator 311 can be in contact with the side surface 343 of the
spacer 340 when the implant 300 is in the second configuration. In
such embodiments, after the actuator 311 moves a predetermined
distance along the longitudinal axis A.sub.L, the actuator 311 can
contact the spacer 340, limiting the range of motion of the
actuator 311 relative to the spacer 340.
[0105] When the implant 300 is in the second configuration, the
first retention member 320 is offset from the spacer 340 in a
direction substantially normal to the longitudinal axis A.sub.L, as
shown by arrow EEE in FIG. 6. Said another way, the outer surface
321 of the first retention member 320 is spaced apart from the
outer surface 341 of the spacer 340 by a distance D7. Similarly,
the second retention member 330 is offset from the spacer 340 in a
direction normal to the longitudinal axis A.sub.L, as shown by
arrow FFF in FIG. 6. Said another way, the outer surface 331 of the
second retention member 330 is spaced apart from the outer surface
341 of the spacer 340 by a distance D8. Said yet another way, the
outer surface 321 of the first retention member 320 and the outer
surface 331 of the second retention member 330 are not aligned with
the outer surface 341 of the spacer 340 and are discontinuous with
the outer surface 341 of the spacer 340.
[0106] In use, the implant 300 can be inserted between a first
spinous process SP1 and a second spinous process SP2 when the
implant 300 is in the first configuration (see e.g., FIG. 5). For
example, a medical practitioner can insert the implant 300
percutaneously (e.g., through a cannula, over a guide wire, or the
like) into a body of a patient. In some embodiments, a tool, such
as those described in U.S. patent application Attorney Docket No.
KYPH-040/02US 305363-2272 entitled "Tools and Methods for insertion
and Removal of Medical Implants," which is incorporated herein by
reference in its entirety, can be used to insert the implant 300
into a body of a patient.
[0107] After the implant 300 is between the first spinous process
SP1 and the second spinous process SP2, the implant 300 can be
moved from the first configuration to the second configuration (see
e.g., FIG. 6). In some embodiments, the implant 300 can be actuated
using a tool (not shown) configured to move the actuator 311
relative to the spacer 340 when the implant 300 is within the body.
Such tools can be configured to maintain the spacer 340 in a fixed
position while exerting a force on the actuator 311. Such tools can
include, for example, those tools described in U.S. patent
application Attorney Docket No. KYPH-040/02US 305363-2272 entitled
"Tools and Methods for Insertion and Removal of Medical Implants,"
which is incorporated herein by reference in its entirety. When the
implant 300 is in the second configuration, the first retention
member 320 and the second retention member 330 limit the movement
of the implant 300 in the direction shown by arrow DDD in FIG. 6,
with respect to the first spinous process SP1 and the second
spinous process SP2.
[0108] A medical practitioner can remove from and/or reposition the
implant 300 within the body multiple times. To remove from and/or
reposition the implant 300 within the body, the implant 300 is
moved from the second configuration to the first configuration.
This can be done by moving the first retention member 320 and the
second retention member 360 to their first positions and thus the
implant 300 to its first configuration. After the implant 300 is in
the first configuration, the medical practitioner can remove from
and/or reposition the implant 300 within the body.
[0109] In some embodiments, the actuator can have a second tapered
portion to facilitate insertion of the implant 300 into the body.
More particularly, the second tapered portion can distract, dilate
and/or pierce bodily tissue. In some embodiments, for example, the
second tapered portion can pierce a bodily tissue, such as an
interspinous ligament, when the implant 300 is inserted into the
body. In some embodiments, the second tapered portion can dilate a
bodily tissue, such as the interspinous ligament, when the implant
300 is inserted into the body. In some embodiments, the second
tapered portion can distract a space between adjacent spinous
processes when the implant 300 is inserted into the body.
[0110] In some embodiments, angle .theta..sub.3 does not equal
angle .theta..sub.5. In such an embodiment, when the implant 300 is
in the second configuration, the outer surface 321 of the first
retention member 320 and the outer surface 331 of the second
retention member 330 are spaced apart from the outer surface 341 by
unequal distances. Accordingly, if angle .theta..sub.3 is greater
than angle .theta..sub.5, the outer surface 331 of the second
retention member 330 will be spaced further apart from the outer
surface 341 of the spacer 340 than the outer surface 321 of the
first retention member 320. Said another way, distance D8 is
greater than distance D7.
[0111] FIGS. 7-13 show an implant 1100, according to an embodiment.
Implant 1100 includes a distal end portion 1110, a central portion
1140 and a proximal end portion 1180. At least a portion of the
central portion 1140 is disposed between the distal end portion
1110 and the proximal end portion 1180. The implant 1100 defines a
lumen 1146 and includes a drive screw 1183 disposed within the
lumen 1146. Drive screw 1183 has a tool head 1184 configured to
mate with and/or receive an actuator of an insertion tool for
rotating the drive screw 1183, as described in U.S. patent
application Attorney Docket No. KYPH-040/02US 305363-2272 entitled
"Tools and Methods for insertion and Removal of Medical Implants,"
which is incorporated herein by reference in its entirety.
[0112] Distal end portion 1110 of implant 1100 includes an actuator
1111 and a distal retention member 1120. Actuator 1111 includes a
tapered surface 1112, a threaded portion 1114 (see FIG. 12), an
engagement surface 1116, and a protrusion 1118. The threaded
portion 1114 is disposed fixedly within the lumen 1146 and is
configured to receive the drive screw 1183. In other embodiments,
the actuator 1111 can include a captive nut configured to receive
the drive screw 1183.
[0113] The engagement surface 1116 of the actuator 1111 is
angularly offset from the longitudinal axis A.sub.L of the implant
1100 by an angle between 0 degrees and 90 degrees. Said another
way, the engagement surface 1116 of the actuator 1111 is angularly
offset from the longitudinal axis A.sub.L of the implant 1100 by an
acute angle. As described above, the angular offset of the
engagement surface 1116 is associated with moving the implant 1100
between a first configuration (FIG. 7) and a second configuration
(FIG. 8).
[0114] The protrusion 1118 of the engagement surface 1116 has an
undercut such that the distal retention member 1120 is slidably
coupled to the actuator 1111. More particularly, the protrusion
1118 has a trapezoidal cross-sectional shape. In this embodiment,
the protrusion 1118 is a dovetail protrusion.
[0115] Distal retention member 1120 includes an outer surface 1121,
a first engagement surface 1122, and a second engagement surface
1123 opposite the first engagement surface 1122. The distal
retention member 1120 defines a notch 1128 (see FIG. 11) configured
to allow the drive screw 1183 to pass through the distal retention
member 1120 when the implant 1100 is in the first configuration.
Said another way, when the implant 1100 is in the first
configuration, the notch 1128 is aligned with the lumen 1146.
[0116] The first engagement surface 1122 of the distal retention
member 1120 defines a plane that is angularly offset from the
longitudinal axis A.sub.L of the implant 1100 by an angle between
90 degrees and 180 degrees. Said another way, the first engagement
surface 1122 of the distal retention member 1120 defines a plane
that is angularly offset from the longitudinal axis A.sub.L by an
obtuse angle. Moreover, the first engagement surface 1122 of the
distal retention member 1120 is substantially parallel to the
engagement surface 1116 of the actuator 1111. Said another way, the
angular offset of the first engagement surface 1122 of the distal
retention member 1120 is supplementary with the angular offset of
the engagement surface 1116 of the actuator 1111. Accordingly, the
distal retention member 1120 is slidably disposed against actuator
1111.
[0117] The first engagement surface 1122 of the distal retention
member 1120 defines a first groove 1124 having a trapezoidal
cross-sectional shape. In this embodiment, the first groove 1124
has a dovetail shape that corresponds to the shape of the
protrusion 1118 of the actuator 1111. The first groove 1124 is
configured to slidingly receive the protrusion 1118 of the actuator
1111. The undercut of the protrusion 1118 of the actuator 1111
slidably maintains the protrusion 1118 of the actuator 1111 within
the first groove 1124. The first groove 1124 of the first
engagement surface 1122 and the protrusion 1118 of the actuator
1111 collectively allow movement of the distal retention member
1120, with respect to the actuator 1111, in a direction
substantially parallel to the first engagement surface 1122 of the
distal retention member 1120. Moreover, the first groove 1124 of
the first engagement surface 1122 and the protrusion 1118 of the
actuator 1111 collectively limit movement of the distal retention
member 1120, with respect to the actuator 1111, in a direction
substantially normal to the first engagement surface 1122 of the
distal retention member 1120. The first engagement surface 1122 of
the distal retention member 1120 contacts and is configured to
slide along the engagement surface 1116 of the actuator 1111 when
the first groove 1124 slides about the protrusion 1118 of the
actuator 1111. In this manner, the first groove 1124 and the
protrusion 1118 collectively maintain the actuator 1111 in sliding
contact with the distal retention member 1120.
[0118] The second engagement surface 1123 of the distal retention
member 1120 is substantially parallel to the distal engagement
surface 1143 of the central portion 1140 and defines a plane
substantially normal to the longitudinal axis A.sub.L of the
implant 1100. The second engagement surface 1123 of the distal
retention member 1120 defines a second groove 1126. The second
groove 1126 has a shape that corresponds to the shape of the distal
protrusion 1145 of the central portion 1140. The second engagement
surface 1123 of the distal retention member 1120 is slidably
disposed against and/or coupled to the central portion 1140 of the
implant 1100, as described in more detail herein.
[0119] Proximal end portion 1180 of implant 1100 includes a tool
engagement member 1182 and a proximal retention member 1160. Tool
engagement member 1182 is configured to mate with and/or receive an
insertion tool, as described in more detail below. Tool engagement
member 1182 includes an engagement surface 1186 and a protrusion
1188. The engagement surface 1186 of the tool engagement member
1182 is angularly offset from the longitudinal axis A.sub.L of the
implant 1100 by an angle between 0 degrees and 90 degrees. Said
another way, the engagement surface 1186 of the tool engagement
member 1182 is angularly offset from the longitudinal axis A.sub.L
of the implant 1100 by an acute angle. As described above, the
angular offset of the engagement surface 1186 is associated with
moving the implant 1100 between a first configuration (FIG. 7) and
a second configuration (FIG. 8).
[0120] The protrusion 1188 of the engagement surface 1186 has an
undercut such that the proximal retention member 1160 can be
slidably coupled to the tool engagement member 1182. More
particularly, the protrusion 1188 has a trapezoidal cross-sectional
shape. In some embodiments, the protrusion 1188 is a dovetail
protrusion.
[0121] Proximal retention member 1160 includes an outer surface
1161, a first engagement surface 1162, and a second engagement
surface 1163 opposite the first engagement surface 1162. The
proximal retention member 1160 defines a notch 1168 (see FIG. 11)
configured to allow the drive screw 1183 to pass through the
proximal retention member 1160 when the implant 1100 is in the
first configuration. Said another way, when the implant 1100 is in
the first configuration, the notch 1168 is aligned with the lumen
1146.
[0122] The first engagement surface 1162 of the proximal retention
member 1160 defines a plane that is angularly offset from the
longitudinal axis A.sub.L of the implant 1160 by an angle between
90 degrees and 180 degrees. The first engagement surface 1162 of
the proximal retention member 1160 is substantially parallel to the
engagement surface 1186 of the tool engagement member 1182. Said
another way, the angular offset of the first engagement surface
1162 of the proximal retention member 1160 is supplementary with
the angular offset of the engagement surface 1186 of the tool
engagement member 1182. Accordingly, the proximal retention member
1160 is slidably disposed against the tool engagement member
1182.
[0123] Moreover, the first engagement surface 1162 of the proximal
retention member 1160 defines a first groove 1164 having a
trapezoidal cross-sectional shape. In this embodiment, the first
groove 1164 has a dovetail shape that corresponds to the shape of
the protrusion 1188 of the tool engagement member 1182. The first
groove 1164 is configured to slidably receive the protrusion 1188
of the tool engagement member 1182. The undercut of the protrusion
1188 of the tool engagement member 1182 maintains the protrusion
1188 of the tool engagement member 1182 within the first groove
1164. The first groove 1164 of the first engagement surface 1162
and the protrusion 1188 of the tool engagement member 1182
collectively allow movement of the proximal retention member 1160,
with respect to the tool engagement member 1182, in a direction
substantially parallel to the second engagement surface 1163 of the
proximal retention member 1160. Moreover, the first groove 1164 of
the first engagement surface 1162 and the protrusion 1188 of the
tool engagement member 1182 collectively limit movement of the
proximal retention member 1160, with respect to the tool engagement
member 1182, in a direction substantially normal to the second
engagement surface 1163 of the proximal retention member 1160. The
first engagement surface 1162 of the proximal retention member 1160
contacts and is configured to slide along the engagement surface
1186 of the tool engagement member 1182 when the first groove 1164
of the proximal retention member 1160 slides along the protrusion
1188 of the tool engagement member 1182. In this manner, the first
groove 1164 and the protrusion 1188 collectively maintain the tool
engagement member 1182 in sliding contact with the proximal
retention member 1160.
[0124] The second engagement surface 1163 of the proximal retention
member 1160 is substantially parallel to the proximal engagement
surface 1142 of the central portion 1140 and defines a plane
substantially normal to the longitudinal axis A.sub.L of the
implant 1100. In other embodiments, however, the plane defined by
the second engagement surface 1163 of the proximal retention member
1160 can be angularly offset from the longitudinal axis A.sub.L of
the implant 1100 by an angle other than 90 degrees. Moreover, the
second engagement surface 1163 of the proximal retention member
1160 defines a second groove 1166. The second groove 1166 has a
shape that corresponds to the shape of the proximal protrusion 1144
of the central portion 1140. The second engagement surface 1163 of
the proximal retention member 1160 is slidably disposed against
and/or coupled to the central portion 1140 of the implant 1100, as
described in more detail herein.
[0125] The central portion 1140 of implant 1100 includes a proximal
engagement surface 1142, a distal engagement surface 1143, a
proximal protrusion 1144, a distal protrusion 1145 and an outer
surface 1141. The distal retention member 1120 is slidably coupled
to the central portion 1140. More particularly, the second groove
1126 of the distal retention member 1120 is configured to slidingly
receive the distal protrusion 1145 of the central portion 1140. The
second engagement surface 1123 of the distal retention member 1120
contacts and is configured to slide along the distal engagement
surface 1143 of the central portion 1140 when the second groove
1126 of the distal retention member 1120 slides along the distal
protrusion 1145 of the central portion 1140.
[0126] Similarly, the proximal retention member 1160 is slidably
coupled to the central portion 1140. The second groove 1166 of the
proximal retention member 1160 is configured to slidingly receive
the proximal protrusion 1144 of the central portion 1140. The
proximal protrusion 1144 of the central portion 1140 is slidably
maintained within the second groove 1166 of the proximal retention
member 1160. The second engagement surface 1163 of the proximal
retention member 1160 contacts and is configured to slide along the
proximal engagement surface 1142 of the central portion 1140 when
the second groove 1166 of the proximal retention member 1160 slides
along the proximal protrusion 1144 of the central portion 1140.
[0127] Implant 1100 has a first configuration (FIG. 7) and a second
configuration (FIG. 8). As shown in FIG. 7, when the implant 1100
is in the first configuration, the proximal end portion 1180, the
distal end portion 1110 and the central portion 1140 are
substantially coaxial (i.e., substantially share a common
longitudinal axis). Said another way, when the implant 1100 is in
the first configuration, the outer surface 1121 of the distal
retention member 1120 and the outer surface 1161 of the proximal
retention member 1160 are substantially aligned with the outer
surface 1141 of the central portion 1140. Said another way, the
outer surface 1121 of the distal retention member 1120, the outer
surface 1161 of the proximal retention member 1160, and the outer
surface 1141 of the central portion 1140 form a substantially
continuous surface. Said yet another way, the outer surface 1121 of
the distal retention member 1120 and the outer surface 1161 of the
proximal retention member 1160 are flush with the outer surface
1141 of the central portion 1140.
[0128] The implant 1100 can be moved between the first
configuration and the second configuration as illustrated in FIG.
8. To move the implant 1100 from the first configuration to the
second configuration, the drive screw 1183 is rotated as indicated
by the arrow CC in FIG. 7. When the drive screw 1183 is rotated,
the drive screw 1183 moves the actuator 1111 and the tool
engagement member 1182 toward the central portion 1140. More
particularly, when the drive screw 1183 is rotated, the engagement
surface 1116 of the actuator 1111 exerts an axial force on the
first engagement surface 1122 of the distal retention member 1120.
Because the engagement surface 1116 of the actuator 1111 is at an
acute angle with respect to the longitudinal axis A.sub.L, a
component of the axial force transmitted via the engagement surface
1116 to the first engagement surface 1122 of the distal retention
member 1120 has a direction as shown by the arrow AA in FIG. 8.
Said another way, a component of the force exerted by the actuator
1111 on the distal retention member 1120 has a direction that is
substantially normal to the longitudinal axis A.sub.L. This force
causes the distal retention member 1120 to slide on the engagement
surface 1116 of the actuator 1111 causing the distal retention
member 1120 to move in the direction AA and into the second
configuration. Once the distal retention member 1120 slides on the
engagement surface 1116 of the actuator 1111 a predetermined
distance, a portion of the engagement surface 1116 of the actuator
1111 contacts a portion of the distal engagement surface 1143 of
the central portion 1140 (see e.g., FIG. 9) preventing the distal
retention member 1120 from sliding further.
[0129] Similarly, when the drive screw 1183 is rotated as indicated
by the arrow CC in FIG. 7, the engagement surface 1186 of the tool
engagement member 1182 exerts an axial force on the first
engagement surface 1162 of the proximal retention member 1160.
Because the engagement surface 1186 of the tool engagement member
1182 is at an acute angle with respect to the longitudinal axis
A.sub.L, a component of the axial force transmitted via the
engagement surface 1186 to the first engagement surface 1162 of the
proximal retention member 1160 has a direction as shown by the
arrow AA in FIG. 8. Said another way, a component of the force
exerted by the tool engagement member 1182 on the proximal
retention member 1160 has a direction that is substantially normal
to the longitudinal axis A.sub.L. This force causes the proximal
retention member 1160 to slide on the engagement surface 1186 of
the tool engagement member 1182 causing the proximal retention
member 1160 to move in the direction AA and into the second
configuration. Once the proximal retention member 1160 slides on
the engagement surface 1186 of the tool engagement member 1182 a
predetermined distance, a portion of the engagement surface 1186 of
the tool engagement member 1182 contacts the proximal engagement
surface 1142 of the central portion 1140 preventing the proximal
retention member 1160 from sliding further.
[0130] When the implant 1100 is in the second configuration the
distal retention member 1120 and/or the proximal retention member
1160 are offset from the central portion 1140 in a direction
substantially normal to the longitudinal axis A.sub.L. Said another
way, the outer surface 1121 of the distal retention member 1120
and/or the outer surface 1161 of the proximal retention member 1160
are not aligned with the outer surface 1141 of the central portion
1140 and are discontinuous with the outer surface 1141 of the
central portion 1140.
[0131] In use, implant 1100 in the first configuration, is inserted
percutaneously between a pair of adjacent spinous processes (not
shown in FIGS. 7-13). For example, a medical practitioner can
insert the implant 1100 percutaneously (e.g., through a cannula,
over a guide wire, or the like) into a body of a patient. In some
embodiments, an insertion tool such as those described in U.S.
patent application Attorney Docket No. KYPH-040/02US 305363-2272
entitled "Tools and Methods for insertion and Removal of Medical
Implants," which is incorporated herein by reference in its
entirety, can be used to insert the implant 1100 into a body of a
patient. The insertion tool can be configured to be removably
coupled to the tool engagement member 1182 such that rotation of
the tool engagement member 1182 relative to the insertion tool
about the longitudinal axis A.sub.L is limited. In some
embodiments, the insertion tool can be configured to be removably
coupled to the tool engagement member 1182 such that axial movement
of the tool engagement member 1182 relative to the insertion tool
is limited. In some embodiments, for example, the insertion tool
can be coupled to an outer surface of the tool engagement member
1182. In such embodiments, the outer surface of the tool engagement
member 1182 can be configured to facilitate the docking of the
insertion tool (not shown) to the implant 1100. For example, in
some embodiments, the outer surface of the tool engagement member
1182 can include a lead-in chamfer, a tapered portion and/or a
beveled edge to facilitate the docking of the insertion tool onto
the tool engagement member 1182 of the implant 1100. In other
embodiments, the insertion tool can be matingly coupled to a
protrusion and/or a recess of the tool engagement member. The
insertion tool can include an actuator configured to be inserted
into the tool head 1184 of the drive screw 1183 to rotate the drive
screw 1183 about the longitudinal axis A.sub.L. This arrangement
allows the drive screw 1183 to be rotated without rotating the
other portions of the implant 1100.
[0132] When inserting the implant 1100 into a body of a patient,
the distal end portion 1110 of the implant 1100 is inserted first
and is moved past the spinous processes until at least a portion of
the central portion 1140 is positioned within a space between the
spinous processes. In this manner, the central portion 1140 of the
implant 1100 can distract and/or maintain a minimal spacing between
the adjacent spinous processes. The distance between the top
portion and the bottom portion of the outer surface 1141 of the
central portion 1140 can be slightly smaller than the space between
the spinous processes to account for surrounding ligaments and
tissue. Similar to the central portion 140 of implant 100, in some
embodiments, the central portion 1140 in the first configuration
directly contacts the spinous processes between which it is
positioned. In some embodiments, the central portion 1140 of
implant 1100 is a relatively fixed size and is not substantially
compressible or expandable.
[0133] Once between the spinous processes, the implant 1100 can be
moved from the first configuration to the second configuration. As
described above, the implant 1100 can be moved between the first
configuration and the second configuration in situ using an
insertion tool. In the second configuration, the proximal retention
member 1160 and the distal retention member 1120 are offset from
the central portion 1140 and positioned to limit lateral movement
of the implant 1100 with respect to the spinous processes. The
proximal retention member 1160 and the distal retention member 1120
are configured to engage the superior spinous process (i.e., either
directly or through surrounding tissue) and/or be adjacent to the
superior spinous process when in the second configuration. Said
another way, the distal retention member 1120, the proximal
retention member 1160 and the spacer 1140 form a saddle, within
which a spinous process can be disposed. Once the implant 1100 is
in the second configuration, the implant 1100 can be released from
the insertion tool and the insertion tool can be removed from the
patient's body. Although described as engaging the superior spinous
process, in other embodiments, the implant 1100 can be oriented
within the body such that the proximal retention member 1160 and
the distal retention member 1120 engage the inferior spinous
process when actuated.
[0134] To remove from and/or reposition the implant 1100 within the
body, the drive screw 1183 is rotated as indicated by the arrow DD
in FIG. 7, by for example, a removal tool (may be similar to an
insertion tool). Rotating the drive screw in direction DD causes
the dovetail configuration of the protrusion 1118 of the actuator
1111 and/or the dovetail configuration of the protrusion 1188 of
the tool engagement member 1182 to pull the distal retention member
1120 and the proximal retention member 1160 back into the first
configuration. After the implant 1100 is in the first
configuration, a medical practitioner can remove the implant 1100
from and/or reposition the implant 1100 within the body.
[0135] FIGS. 14-21 show an implant 2100, according to an
embodiment. Implant 2100 includes a distal end portion 2110, a
central portion 2140 and a proximal end portion 2180. At least a
portion of the central portion 2140 is disposed between the distal
end portion 2110 and the proximal end portion 2180. The implant
2100 defines a lumen 2146 (see e.g., FIGS. 20 and 21) and includes
a drive screw 2183 disposed within the lumen 2146. Drive screw 2183
has a tool head 2184 configured to mate with and/or receive a tool
for rotating the drive screw 2183, as further described herein.
[0136] The distal end portion 2110 of implant 2100 includes an
actuator 2111 and a distal retention member 2120. Actuator 2111
includes a tapered surface 2112, a threaded portion 2114 (see FIG.
16), and an engagement surface 2116. The threaded portion 2114 is
disposed fixedly within the lumen 2146 and is configured to receive
the drive screw 2183, as described above. The engagement surface
2116 of the actuator 2111 is angularly offset from the longitudinal
axis A.sub.L of the implant 2100 by an angle between 0 degrees and
90 degrees. As described in more detail herein, the angular offset
of the engagement surface 2116 is associated with moving the
implant 2100 between a first configuration (FIG. 14) and a second
configuration (FIG. 17). The engagement surface 2116 includes a
protrusion 2118 having an undercut such that the distal retention
member 2120 can be coupled to the actuator 2111. More particularly,
the protrusion 2118 has a trapezoidal cross-sectional shape. In
some embodiments, the protrusion 2118 is a dovetail protrusion.
[0137] Distal retention member 2120 includes an outer surface 2121,
a first engagement surface 2122, and a second engagement surface
2123 opposite the first engagement surface 2122. The distal
retention member 2120 defines a notch 2128 (see FIG. 19) configured
to allow the drive screw 2183 to pass through the distal retention
member 2120 when the implant 2100 is in the first configuration.
The first engagement surface 2122 of the distal retention member
2120 defines a plane that is angularly offset from the longitudinal
axis A.sub.L of the implant 2100 by an angle between 90 degrees and
180 degrees. Moreover, the first engagement surface 2122 of the
distal retention member 2120 is substantially parallel to the
engagement surface 2116 of the actuator 2111. Accordingly, the
distal retention member 2120 is slidably disposed against actuator
2111.
[0138] The first engagement surface 2122 of the distal retention
member 2120 defines a first groove 2124 having a trapezoidal
cross-sectional shape. In this embodiment, the first groove 2124
has a dovetail shape that corresponds to the shape of the
protrusion 2118 of the actuator 2111. The first groove 2124 of the
first engagement surface 2122 and the protrusion 2118 of the
actuator 2111 collectively allow movement of the distal retention
member 2120, with respect to the actuator 2111, in a direction
substantially parallel to the second engagement surface 2123 of the
distal retention member 2120. Moreover, the first groove 2124 of
the first engagement surface 2122 and the protrusion 2118 of the
actuator 2111 collectively limit movement of the distal retention
member 2120, with respect to the actuator 2111, in a direction
substantially normal to the second engagement surface 2123 of the
distal retention member 2120. The first engagement surface 2122 of
the distal retention member 2120 contacts and is configured to
slide along the engagement surface 2116 of the actuator 2111 when
the first groove 2124 slides along the protrusion 2118 of the
actuator 2111.
[0139] The second engagement surface 2123 of the distal retention
member 2120 is substantially parallel to the distal engagement
surface 2143 of the central portion 2140 and defines a plane
substantially normal to the longitudinal axis A.sub.L of the
implant 2100. The second engagement surface 2123 of the distal
retention member 2120 defines a second groove 2126 having a
trapezoidal cross-sectional shape. In this embodiment, the second
groove 2126 has a dovetail shape that corresponds to the shape of
the distal protrusion 2145 of the central portion 2140. The second
groove 2126 of the second engagement surface 2123 and the distal
protrusion 2145 of the central body 2140 collectively limit
movement of the distal retention member 2120, with respect to the
central portion 2140, in a direction substantially normal to the
second engagement surface 2123 of the distal retention member 2120.
The second engagement surface 2123 of the distal retention member
2120 is slidably disposed against and/or coupled to the central
portion 2140 of the implant 2100, as described in more detail
herein.
[0140] As shown in FIGS. 18-19, the first engagement surface 2122
of the distal retention member 2120 is non-parallel to the second
engagement surface 2123 of the distal retention member 2120. The
mating protrusion and grooves, as discussed above, and the
non-parallel arrangement of the first engagement surface 2122 and
the second engagement surface 2123 collectively lock the distal
retention member 2120 between the actuator 2111 and the central
body 2140. Said another way, because the first groove 2124 and the
protrusion 2118 of the actuator 2111 collectively limit movement of
the distal retention member 2120, with respect to the actuator
2111, in a direction substantially normal to the second engagement
surface 2123 and the second groove 2126 and the distal protrusion
2145 of the central body 2140 collectively limit movement of the
distal retention member 2120, with respect to the central portion
2140, in a direction substantially normal to the second engagement
surface 2123, the distal retention member 2120 cannot move unless
the actuator 2111 is moved. This arrangement prevents the distal
retention member 2120 from becoming inadvertently decoupled from
the actuator 2111 and/or the central body 2140.
[0141] Proximal end portion 2180 of implant 2100 includes a tool
engagement member 2182 and a proximal retention member 2160. Tool
engagement member 2182 is configured to mate with and/or receive an
insertion tool. Tool engagement member 2182 includes an engagement
surface 2186 and a hex portion 2185. The hex portion 2185 includes
a hexagonal shaped outer surface configured to be matingly received
within a portion of an insertion tool. In this manner, the hex
portion 2185 of the tool engagement member 2182 can limit
rotational motion of the implant 2100 about the longitudinal axis
A.sub.L, when the implant 2100 is coupled to an insertion tool. In
some embodiments, the hexagonal shaped outer surface of the hex
portion 2185 can be configured to facilitate the docking of the
insertion tool (not shown) onto the hex portion 2185 of the implant
2100. For example, in some embodiments, the outer surface of the
hex portion 2185 can include a lead-in chamfer, a tapered portion
and/or a beveled edge to facilitate the docking of the insertion
tool onto the hex portion 2185 of the implant 2100.
[0142] The hex portion 2185 defines a threaded portion 2190
configured to mate with and/or receive a corresponding threaded
portion of an insertion tool (not shown). In some embodiments, for
example, the threaded portion 2190 can receive a portion of the
threaded intermediate shaft 1430 of the tool shown and described in
U.S. patent application Attorney Docket No. KYPH-040/02US
305363-2272 entitled "Tools and Methods for insertion and Removal
of Medical Implants," which is incorporated herein by reference in
its entirety. In this manner, the threaded portion 2190 can limit
axial movement of the implant 2100 with respect to the insertion
tool when the implant 2100 is inserted into a body of a patient, as
described in further detail below. Moreover, when the shaft of the
insertion tool is coupled within the threaded portion 2190,
movement of the drive screw 2183 along the longitudinal axis
relative to the tool engagement member 2182 is limited. In this
manner, the coupling of an insertion tool within the threaded
portion 2190 can prevent the drive screw 2183 from moving, thereby
maintaining the implant 2100 in the first configuration. In other
embodiments, the threaded portion 2190 can include a retainer
(e.g., a snap ring, an E-ring or the like) to prevent translation
of the drive screw 2183 relative to the tool engagement member
2182.
[0143] Similar to the engagement surface 1186 of the tool
engagement member 1182, the engagement surface 2186 of the tool
engagement member 2182 is angularly offset from the longitudinal
axis A.sub.L of the implant 2100 by an angle between 0 degrees and
90 degrees. The engagement surface 2186 includes a protrusion 2188
having an undercut such that the proximal retention member 2160 can
be coupled to the tool engagement member 2182. More particularly,
the protrusion 2188 has a trapezoidal cross-sectional shape. In
this embodiment, the protrusion 2188 is a dovetail protrusion.
[0144] Proximal retention member 2160 includes an outer surface
2161, a first engagement surface 2162, and a second engagement
surface 2163 opposite the first engagement surface 2162. The
proximal retention member 2160 defines a notch 2168 (see FIG. 21)
configured to allow the drive screw 2183 to pass through the
proximal retention member 2160 when the implant 2100 is in the
first configuration. The first engagement surface 2162 of the
proximal retention member 2160 defines a plane that is angularly
offset from the longitudinal axis A.sub.L of the implant 2160 by an
angle between 90 degrees and 180 degrees. Moreover, the first
engagement surface 2162 of the proximal retention member 2160 is
substantially parallel to the engagement surface 2186 of the tool
engagement member 2182. Accordingly, the proximal retention member
2160 is slidably disposed against the tool engagement member
2182.
[0145] The first engagement surface 2162 of the proximal retention
member 2160 defines a first groove 2164 having a trapezoidal
cross-sectional shape. In this embodiment, the first groove 2164
has a dovetail shape that corresponds to the shape of the
protrusion 2188 of the tool engagement member 2182. The undercut of
the protrusion 2188 of the tool engagement member 2182 slidably
maintains the protrusion 2188 of the tool engagement member 2182
within the first groove 2164. More particularly, the first groove
2164 of the first engagement surface 2162 and the protrusion 2188
of the tool engagement member 2182 collectively allow movement of
the proximal retention member 2160, with respect to the tool
engagement member 2182, in a direction substantially parallel to
the second engagement surface 2163 of the proximal retention member
2160. Moreover, the first groove 2164 of the first engagement
surface 2162 and the protrusion 2188 of the tool engagement member
2182 collectively limit movement of the proximal retention member
2160, with respect to the tool engagement member 2182, in a
direction substantially normal to the second engagement surface
2163 of the proximal retention member 2160. The first engagement
surface 2162 of the proximal retention member 2160 contacts and is
configured to slide along the engagement surface 2186 of the tool
engagement member 2182 when the first groove 2164 of the proximal
retention member 2160 slides along the protrusion 2188 of the tool
engagement member 2182.
[0146] The second engagement surface 2163 of the proximal retention
member 2160 is substantially parallel to the proximal engagement
surface 2142 of the central portion 2140 and defines a plane
substantially normal to the longitudinal axis A.sub.L of the
implant 2100. The second engagement surface 2163 of the proximal
retention member 2160 defines a second groove 2166 having a
trapezoidal cross-sectional shape. In this embodiment, the second
groove 2166 has a dovetail shape that corresponds to the shape of
the proximal protrusion 2144 of the central portion 2140. The
second groove 2166 of the second engagement surface 2163 and the
proximal protrusion 2144 of the central portion 2140 collectively
limit movement of the proximal retention member 2160, with respect
to the central body 2140, in a direction substantially normal to
the second engagement surface 2163 of the proximal retention member
2160. The second engagement surface 2163 of the proximal retention
member 2160 is slidably disposed against and/or coupled to the
central portion 2140 of the implant 2100, as described in more
detail herein.
[0147] As shown in FIGS. 18-19, the first engagement surface 2162
of the proximal retention member 2160 is non-parallel to the second
engagement surface 2163 of the proximal retention member 2160. The
mating protrusion and grooves, as discussed above, and the
non-parallel arrangement of the first engagement surface 2162 and
the second engagement surface 2163 collectively lock the proximal
retention member 2160 between the tool engagement member 2182 and
the central body 2140. Said another way, because the first groove
2164 and the protrusion 2188 of the tool engagement member 2182
collectively limit movement of the proximal retention member 2160,
with respect to the tool engagement member 2182, in a direction
substantially normal to the first engagement surface 2162 and the
second groove 2166 and the proximal protrusion 2144 of the central
body 2140 collectively limit movement of the proximal retention
member 2160, with respect to the central portion 2140, in a
direction substantially normal to the second engagement surface
2163, the proximal retention member 2160 cannot move unless the
tool engagement member 2182 is moved. This arrangement prevents the
proximal retention member 2160 from becoming inadvertently
decoupled from the tool engagement member 2182 and/or the central
body 2140.
[0148] The central portion 2140 of implant 2100 includes a proximal
engagement surface 2142, a distal engagement surface 2143, a
proximal protrusion 2144, a distal protrusion 2145 and an outer
surface 2141. The distal retention member 2120 is slidably coupled
to the central portion 2140. The second groove 2126 of the distal
retention member 2120 is configured to slidingly receive the distal
protrusion 2145 of the central portion 2140. The distal protrusion
2145 of the central portion 2140 has a dovetail shape slidably
maintaining it within the second groove 2126 of the distal
retention member 2120. The second engagement surface 2123 of the
distal retention member 2120 contacts and is configured to slide
along the distal engagement surface 2143 of the central portion
2140 when the second groove 2126 of the distal retention member
2120 slides along the distal protrusion 2145 of the central portion
2140.
[0149] Similarly, the proximal retention member 2160 is slidably
coupled to the central portion 2140. The second groove 2166 of the
proximal retention member 2160 is configured to slidingly receive
the proximal protrusion 2144 of the central portion 2140. The
proximal protrusion 2144 of the central portion 2140 has a dovetail
shape slidably maintaining it within the second groove 2166 of the
proximal retention member 2160. The second engagement surface 2163
of the proximal retention member 2160 contacts and is configured to
slide along the proximal engagement surface 2142 of the central
portion 2140 when the second groove 2166 of the proximal retention
member 2160 slides along the proximal protrusion 2144 of the
central portion 2140.
[0150] The implant 2100 has a first configuration (FIG. 14) and a
second configuration (FIG. 18). When the implant 2100 is in the
first configuration, the proximal end portion 2180, the distal end
portion 2110 and the central portion 2140 are substantially coaxial
(i.e., substantially share a common longitudinal axis). As
described above, the implant 2100 can be moved between the first
configuration and the second configuration by rotating the drive
screw 2183. When the drive screw 2183 is rotated as indicated by
the arrow CC in FIG. 15, the drive screw 2183 moves the actuator
2111 and the tool engagement member 2182 toward the central portion
2140. The engagement surface 2116 of the actuator 2111 exerts an
axial force on the first engagement surface 2122 of the distal
retention member 2120. Because the engagement surface 2116 of the
actuator 2111 is at an acute angle with respect to the longitudinal
axis A.sub.L, a component of the axial force transmitted via the
engagement surface 2116 to the first engagement surface 2122 of the
distal retention member 2120 has a direction as shown by the arrow
AA in FIG. 18. Said another way, a component of the force exerted
by the actuator 2111 on the distal retention member 2120 has a
direction that is substantially normal to the longitudinal axis
A.sub.L. This force causes the distal retention member 2120 to
slide on the engagement surface 2116 of the actuator 2111 causing
the distal retention member 2120 to move in the direction AA and
into the second configuration. Once the distal retention member
2120 slides on the engagement surface 2116 of the actuator 2111 a
predetermined distance, a portion of the engagement surface 2116 of
the actuator 2111 contacts a portion of the distal engagement
surface 2143 of the central portion 2140 preventing the distal
retention member 2120 from sliding further.
[0151] Similarly, when the drive screw 2183 is rotated as indicated
by the arrow CC in FIG. 15, the engagement surface 2186 of the tool
engagement member 2182 exerts an axial force on the first
engagement surface 2162 of the proximal retention member 2160.
Because the engagement surface 2186 of the tool engagement member
2182 is at an acute angle with respect to the longitudinal axis
A.sub.L, a component of the axial force transmitted via the
engagement surface 2186 to the first engagement surface 2162 of the
proximal retention member 2160 has a direction as shown by the
arrow AA in FIG. 18. Said another way, a component of the force
exerted by the tool engagement member 2182 on the proximal
retention member 2160 has a direction that is substantially normal
to the longitudinal axis A.sub.L. This force causes the proximal
retention member 2160 to slide on the engagement surface 2186 of
the tool engagement member 2182 causing the proximal retention
member 2160 to move in the direction AA and into the second
configuration. Once the proximal retention member 2160 slides on
the engagement surface 2186 of the tool engagement member 2180 a
predetermined distance, a portion of the engagement surface 2186 of
the tool engagement member 2180 contacts the proximal engagement
surface 2142 of the central portion 2140 preventing the proximal
retention member 2160 from sliding further. Similar to implant
1100, when the implant 2100 is in the second configuration the
distal retention member 2120 and/or the proximal retention member
2160 are offset from the central portion 2140 in a direction
substantially normal to the longitudinal axis A.sub.L.
[0152] In use, implant 2100 in the first configuration, is inserted
percutaneously between a pair of adjacent spinous processes (not
shown in FIGS. 14-21). For example, a medical practitioner can
insert the implant 2100 percutaneously (e.g., through a cannula,
over a guide wire, or the like) into a body of a patient. In some
embodiments, an insertion tool such as those described in U.S.
patent application Attorney Docket No. KYPH-040/02US 305363-2272
entitled "Tools and Methods for insertion and Removal of Medical
Implants," which is incorporated herein by reference in its
entirety, can be used to insert the implant 2100 into a body of a
patient. The insertion tool can be configured to be removably
coupled to the tool engagement member 2182 such that rotation of
the tool engagement member 2182 relative to the insertion tool
about the longitudinal axis A.sub.L is limited. More particularly,
a portion of the insertion tool can be disposed about the hex
portion 2185 of the tool engagement member 2182 such that
rotational motion about the longitudinal axis A.sub.L is limited.
Additionally, the insertion tool can include a threaded portion
configured to be threadedly coupled within the threaded portion
2190 of the hex portion 2185. In this manner, the insertion tool
can be removably coupled to the tool engagement member 2182 such
that axial movement of the tool engagement member 2182 relative to
the insertion tool is limited.
[0153] The insertion tool can include actuator configured to be
inserted into the tool head 2184 of the drive screw 2183 to rotate
the drive screw 2183 about the longitudinal axis A.sub.L. This
arrangement allows the drive screw 2183 to be rotated without
rotating the other portions of the implant 2100. Accordingly, the
implant 2100 can be inserted into, repositioned within and/or
removed from a body, as described above.
[0154] Once between the spinous processes, the implant 2100 can be
moved from the first configuration to the second configuration. In
the second configuration, the proximal retention member 2160 and
the distal retention member 2120 are offset from the central
portion 2140 and positioned to limit lateral movement of the
implant 2100 with respect to the spinous processes. The proximal
retention member 2160 and the distal retention member 2120 are
configured to engage a spinous process (i.e., either directly or
through surrounding tissue) and/or be adjacent to a spinous process
when in the second configuration. Said another way, the distal
retention member 2120, the proximal retention member 2160 and the
central portion 2140 form a saddle, within which a spinous process
can be disposed.
[0155] FIGS. 22-23 show an implant 3100, according to an
embodiment. As shown in FIG. 22, the implant 3100 includes an
actuator 3111, a distal retention member 3120, a central portion
3140, a proximal retention member 3160, and a tool engagement
member 3182. The structure and operation of the actuator 3111,
distal retention member 3120, central portion 3140, and proximal
retention member 3160 are similar to the structure and operation of
the actuator 2111, distal retention member 2120, central portion
2140, and proximal retention member 2160, respectively.
Accordingly, only the tool engagement member 3182 is described in
detail below.
[0156] Tool engagement member 3182 includes an engagement surface
3186 and a coupling protrusion 3185. The engagement surface 3186
includes a dovetail protrusion 3188, which is similar to the
structure and operation of the engagement surface 2186 and the
protrusion 2188 of implant 2100, respectively. As such, the
engagement surface 3186 and the dovetail protrusion 3188 are not
described in detail.
[0157] The tool coupling protrusion 3185 is configured to be
removably coupled to an insertion tool 3195. Details of the
insertion tool 3195 are described in more detail in copending U.S.
patent application Attorney Docket No. KYPH-040/02US 305363-2272
entitled "Tools and Methods for insertion and Removal of Medical
Implants," which is incorporated herein by reference in its
entirety. Specifically, the tool coupling protrusion 3185 is
configured receive a shaft 3197 of the insertion tool 3195. The end
of the shaft 3197 is configured to engage a tool head 3184 of a
drive screw 3183. In use, the shaft 3197 can rotate the drive screw
3183 to move the implant 3100 between a first configuration and a
second configuration, as described above.
[0158] Moreover, the tool coupling protrusion 3185 includes a
groove 3190 configured to receive a snap-ring 3196 of the insertion
tool 3195. The snap-ring 3196 can be, for example, spring coil. In
this manner, the insertion tool 3195 can retain the implant 3100,
when the implant 3100 is inserted into a body of a patient. More
particularly, the snap-ring 3196 and the groove 3190 can
collectively form an interference fit such both axial and rotation
movement of the implant 3100 relative to the insertion tool 3195 is
limited.
[0159] The tool coupling protrusion 3185 includes a lead-in chamfer
3181 to facilitate the docking of the insertion tool 3195 to the
implant 3100. Although not shown in FIG. 23, in some embodiments,
the lumen defined by the coupling protrusion 3185 can also include
a lead-in chamfer, a tapered portion and/or a beveled edge to
facilitate the insertion of the shaft 3197 the insertion tool 3195
into the coupling protrusion 3185. Said another way, in some
embodiments, the coupling protrusion 3185 can include an
inner-diameter chamfer.
[0160] FIGS. 24-30 show an implant 4100, according to an
embodiment. Implant 4100 includes a distal end portion 4110, a
central portion 4140 and a proximal end portion 4180. At least a
portion of the central portion 4140 is between the distal end
portion 4110 and the proximal end portion 4180. The implant 4100
defines a lumen 4146 and includes a drive screw 4183 disposed
within the lumen 4146. The drive screw 4183 has a tool head 4184
configured to mate with and/or receive a tool for rotating the
drive screw 4183, as further described herein.
[0161] Distal end portion 4110 of implant 4100 includes an actuator
4111, a first distal retention member 4120 and a second distal
retention member 4130. Actuator 4111 includes a tapered surface
4112, a threaded portion 4114 (see FIG. 28), a first engagement
surface 4116, a second engagement surface 4117, a first protrusion
4118, a second protrusion 4119, a first stabilizing pin 4113 and a
second stabilizing pin 4115 (see FIG. 28). The threaded portion
4114 is disposed fixedly within the lumen 4146 and is configured to
receive the drive screw 4183. In other embodiments, the insertion
member can include a captive nut configured to receive the drive
screw. The first stabilizing pin 4113 and the second stabilizing
pin 4115 of the actuator 4111 are elongated members configured to
slidably couple the actuator 4111 to the central portion 4140 to
prevent independent rotational movement of the actuator 4111 with
respect to the central portion 4140.
[0162] The first engagement surface 4116 of the actuator 4111 is
angularly offset from the longitudinal axis A.sub.L of the implant
4100 by an angle between 0 degrees and 90 degrees. As described in
more detail herein, the angular offset of the first engagement
surface 4116 is associated with moving the implant 4100 between a
first configuration (FIG. 24) and a second configuration (FIG.
25).
[0163] The first engagement surface 4116 includes a first
protrusion 4118 having an undercut. More particularly, the first
protrusion 4118 has a trapezoidal cross-sectional shape. In this
embodiment, the first protrusion 4118 is a dovetail protrusion. The
first protrusion 4118 is configured to engage a groove 4124 of the
first distal retention member 4120. Similarly, the second
engagement surface 4117 includes a second protrusion 4119 having an
undercut. More particularly, the second protrusion 4119 has a
trapezoidal cross-sectional shape. In this embodiment, the second
protrusion 4119 is a dovetail protrusion. The second protrusion
4119 is configured to engage a groove 4134 of the second distal
retention member 4130.
[0164] The first distal retention member 4120 includes an outer
surface 4121, a first engagement surface 4122, and a second
engagement surface 4123, opposite the first engagement surface
4122. The first distal retention member 4120 defines a notch 4128
configured to allow the drive screw 4183 to pass therethrough when
the implant 4100 is in the first configuration. Said another way,
when the implant 4100 is in the first configuration, the notch 4128
is aligned with the lumen 4146.
[0165] The first engagement surface 4122 of the first distal
retention member 4120 defines a plane that is angularly offset from
the longitudinal axis A.sub.L of the implant 4100 by an angle
between 90 degrees and 180 degrees. Said another way, the first
engagement surface 4122 of the first distal retention member 4120
defines a plane that is angularly offset from the longitudinal axis
A.sub.L by an obtuse angle. Moreover, the first engagement surface
4122 of the first distal retention member 4120 is substantially
parallel to the first engagement surface 4116 of the actuator 4111.
Said another way, the angular offset of the first engagement
surface 4122 of the distal retention member 4120 is supplementary
to the angular offset of the first engagement surface 4116 of the
actuator 4111. Accordingly, the first distal retention member 4120
is slidably disposed against actuator 4111.
[0166] Moreover, the first engagement surface 4122 of the first
distal retention member 4120 defines a groove 4124. The groove 4124
has a trapezoidal cross-sectional shape. In this embodiment, the
groove 4124 has a dovetail shape that corresponds to the shape of
the first protrusion 4118 of the actuator 4111. The groove 4124 is
configured to slidingly receive the first protrusion 4118 of the
actuator 4111. The undercut of the first protrusion 4118 of the
actuator 4111 slidably maintains the first protrusion 4118 of the
actuator 4111 within the groove 4124. The groove 4124 of the first
engagement surface 4122 and the protrusion 4118 of the actuator
4111 collectively allow movement of the first distal retention
member 4120, with respect to the actuator 4111, in a direction
substantially parallel to the first engagement surface 4122 of the
first distal retention member 4120. Moreover, the groove 4124 of
the first engagement surface 4122 and the protrusion 4118 of the
actuator 4111 collectively limit movement of the first distal
retention member 4120, with respect to the actuator 4111, in a
direction substantially normal to the first engagement surface 4122
of the distal retention member 4120. The first engagement surface
4122 of the first distal retention member 4120 contacts and is
configured to slide along the first engagement surface 4116 of the
actuator 4111 when the groove 4124 slides along the first
protrusion 4118 of the actuator 4111.
[0167] The second engagement surface 4123 of the first distal
retention member 4120 is substantially parallel to the distal
engagement surface 4143 of the central portion 4140 and defines a
plane substantially normal to the longitudinal axis A.sub.L of the
implant 4100. The second engagement surface 4123 of the first
distal retention member 4120 can be slidably disposed against
and/or coupled to the central portion 4140 of the implant 4100.
[0168] The second distal retention member 4130 includes an outer
surface 4131, a first engagement surface 4132, and a second
engagement surface 4133, opposite the first engagement surface
4132. The second distal retention member 4130 defines a notch 4138
configured to allow the drive screw 4183 to pass therethrough when
the implant 4100 is in the first configuration. Moreover, the first
engagement surface 4132 of the second distal retention member 4130
defines a groove 4134. The structure and function of second distal
retention member 4130 is similar to that of the first distal
retention member 4120, and is therefore not described in
detail.
[0169] Proximal end portion 4180 of implant 4100 includes a tool
engagement member 4182, a first proximal retention member 4160 and
a second proximal retention member 4170. Tool engagement member
4182 is configured to mate with and/or receive an insertion tool,
such as those described in copending U.S. patent application
Attorney Docket No. KYPH-040/02US 305363-2272 entitled "Tools and
Methods for insertion and Removal of Medical Implants," which is
incorporated herein by reference in its entirety. In some
embodiments, for example, an insertion tool (not shown) can be
coupled to an outer surface of the tool engagement member 4182. In
such embodiments, the outer surface of the tool engagement member
4182 can be configured to facilitate the docking of the insertion
tool (not shown) to the implant 4100. For example, in some
embodiments, the outer surface of the tool engagement member 4182
can include a lead-in chamfer, a tapered portion and/or a beveled
edge to facilitate the docking of the insertion tool onto the tool
engagement member 4182 of the implant 4100.
[0170] Tool engagement member 4182 includes a first engagement
surface 4186, a second engagement surface 4187, a first stabilizing
pin 4181 and a second stabilizing pin 4185 (see FIG. 28). The first
stabilizing pin 4181 and the second stabilizing pin 4185 of the
tool engagement member 4182 are elongated members configured to
slidably couple the tool engagement member 4182 to the central
portion 4140 to prevent independent rotational movement of the tool
engagement member 4182 with respect to the central portion
4140.
[0171] The first engagement surface 4186 of the tool engagement
member 4182 is angularly offset from the longitudinal axis A.sub.L
of the implant 4100 by an angle between 0 degrees and 90 degrees.
As described in more detail herein, the angular offset of the first
engagement surface 4186 is associated with moving the implant 4100
between a first configuration (FIG. 24) and a second configuration
(FIG. 25).
[0172] The first engagement surface 4186 includes a first
protrusion 4188 having an undercut. More particularly, the first
protrusion 4188 has a trapezoidal cross-sectional shape. In this
embodiment, the first protrusion 4188 is a dovetail protrusion. The
first protrusion 4188 is configured to engage a groove 4164 of the
first proximal retention member 4160. Similarly, the second
engagement surface 4187 of the tool engagement member 4182 includes
a second protrusion 4189 having an undercut. More particularly, the
second protrusion 4189 has a trapezoidal cross-sectional shape. In
this embodiment, the second protrusion 4189 is a dovetail
protrusion. The second protrusion 4189 is configured to engage a
groove 4174 of the second proximal retention member 4170.
[0173] The first proximal retention member 4160 includes an outer
surface 4161, a first engagement surface 4162, and a second
engagement surface 4163, opposite the first engagement surface
4162. The first proximal retention member 4160 defines a notch 4168
configured to allow the drive screw 4183 to pass therethrough when
the implant 4100 is in the first configuration. Said another way,
when the implant 4100 is in the first configuration, the notch 4168
is aligned with the lumen 4146.
[0174] The first engagement surface 4162 of the first proximal
retention member 4160 defines a plane that is angularly offset from
the longitudinal axis A.sub.L of the implant 4100 by an angle
between 90 degrees and 180 degrees. Moreover, the first engagement
surface 4162 of the first proximal retention member 4120 is
substantially parallel to the first engagement surface 4186 of the
tool engagement member 4182. Said another way, the angular offset
of the first engagement surface 4162 of the first proximal
retention member 4160 is supplementary with the angular offset of
the first engagement surface 4186 of the tool engagement member
4182. Accordingly, the first proximal retention member 4160 is
slidably disposed against the tool engagement member 4182.
[0175] The first engagement surface 4162 of the first proximal
retention member 4160 defines a groove 4164. The groove 4164 has a
trapezoidal cross-sectional shape. In this embodiment, the groove
4164 has a dovetail shape that corresponds to the shape of the
first protrusion 4188 of the tool engagement member 4182. The
groove 4164 is configured to slidingly receive the first protrusion
4188 of the tool engagement member 4182. The undercut of the first
protrusion 4188 of the tool engagement member 4182 slidably
maintains the first protrusion 4188 of the tool engagement member
4182 within the first groove 1124. The groove 4164 of the first
engagement surface 4162 and the first protrusion 4188 of the tool
engagement member 4182 collectively allow movement of the first
proximal retention member 4160, with respect to the tool engagement
member 4182, in a direction substantially parallel to the second
engagement surface 4163 of first the proximal retention member
4160. Moreover, the groove 4164 of the first engagement surface
4162 and the first protrusion 4188 of the tool engagement member
4182 collectively limit movement of the first proximal retention
member 4160, with respect to the tool engagement member 4182, in a
direction substantially normal to the first engagement surface 4162
of the first proximal retention member 4160. The first engagement
surface 4162 of the first proximal retention member 4160 contacts
and is configured to slide along the first engagement surface 4186
of the tool engagement member 4182 when the groove 4164 slides
along the first protrusion 4188 of the tool engagement member
4182.
[0176] The second engagement surface 4163 of the first proximal
retention member 4160 is substantially parallel to the proximal
engagement surface 4142 of the central portion 4140 and defines a
plane substantially normal to the longitudinal axis A.sub.L of the
implant 4100. In other embodiments, the plane defined by the second
engagement surface 4163 of the first proximal retention member 4160
can be angularly offset from the longitudinal axis A.sub.L of the
implant 4100 by an angle other than 90 degrees. The second
engagement surface 4163 of the first proximal retention member 4160
can be slidably disposed against and/or coupled to the central
portion 4140 of the implant 4100.
[0177] The second proximal retention member 4170 includes an outer
surface 4171, a first engagement surface 4172, and a second
engagement surface 4173, opposite the first engagement surface
4172. The second proximal retention member 4170 defines a notch
4178 configured to allow the drive screw 4183 to pass through the
second proximal retention member 4170 when the implant 4100 is in
the first configuration. Moreover, the first engagement surface
4172 of the second proximal retention member 4170 defines a groove
4174. The second proximal retention member 4170 is configured
similar to the first proximal retention member 4160, and is
therefore not discussed in detail below.
[0178] The central portion 4140 of implant 4100 includes an outer
surface 4141, a proximal engagement surface 4142 and a distal
engagement surface 4143. The central portion 4140 also defines a
first proximal stabilizing groove 4144, a second proximal
stabilizing groove (not shown in FIG. 28), a first distal
stabilizing groove (not shown in FIG. 28) and a second distal
stabilizing groove 1149 (see FIG. 28).
[0179] The second engagement surface 4163 of the first proximal
retention member 4160 and the second engagement surface 4173 of the
second proximal retention member 4170 are both configured to slide
along the proximal engagement surface 4142 of the central portion
4140. Likewise, the second engagement surface 4123 of the first
distal retention member 4120 and the second engagement surface 4133
of the second distal retention member 4130 are both configured to
slide along the distal engagement surface 4143 of the central
portion 4140.
[0180] FIG. 28 is a cross-sectional view of the implant illustrated
in FIG. 24, taken along line X-X in FIG. 24. The first distal
stabilizing groove (not shown in FIG. 28) and the second distal
stabilizing groove 4149 of the central portion 4140 are configured
to receive the first stabilization pin 4113 and the second
stabilization pin 4115 of the actuator 4111 respectively. Likewise,
the first proximal stabilizing groove 4144 and the second proximal
stabilizing groove (not shown in FIG. 28) of the central portion
4140 are configured to receive the first stabilization pin 4181 and
the second stabilization pin 4185 of the tool engagement member
4182 respectively. This configuration prevents the proximal end
portion 4180 and the distal end portion 4110 from rotating with
respect to the central portion 4140.
[0181] Implant 4100 has a first configuration and a second
configuration. FIG. 24 shows the implant 4100 in a first
configuration. When the implant 4100 is in the first configuration,
the proximal end portion 4180, the distal end portion 4110 and the
central portion 4140 are substantially coaxial (i.e., substantially
share a common longitudinal axis). Said another way, when the
implant 4100 is in the first configuration, the outer surface 4121
of the first distal retention member 4120 and the outer surface
4161 of the first proximal retention member 4160 are substantially
aligned with the outer surface 4141 of the central portion 4140.
Said another way, the outer surface 4121 of the first distal
retention member 4120, the outer surface 4161 of the first proximal
retention member 4160, and the outer surface 4141 of the central
portion 4140 form a substantially continuous surface. Similarly,
the outer surface 4131 of the second distal retention member 4130
and the outer surface 4171 of the second proximal retention member
4170 are similarly aligned with the outer surface 4141 of the
central portion 4140 when the implant 4100 is in the first
configuration.
[0182] The implant 4100 can be moved between the first
configuration and the second configuration as illustrated in FIG.
25. To move the implant 4100 from the first configuration to the
second configuration, the drive screw 4183 is rotated. When the
drive screw 4183 is rotated as indicated by the arrow CC in FIG.
24, the drive screw 4183 pulls the actuator 4111 and the tool
engagement member 4182 toward the central portion 4140. The first
engagement surface 4116 of the actuator 4111 exerts an axial force
on the first engagement surface 4122 of the first distal retention
member 4120 and the second engagement surface 4117 of the actuator
4111 exerts an axial force on the first engagement surface 4132 of
the second distal retention member 4130. Because the first
engagement surface 4116 of the actuator 4111 is at an acute angle
with respect to the longitudinal axis A.sub.L, a component of the
axial force transmitted via the first engagement surface 4116 of
the actuator 4111 to the first engagement surface 4122 of the first
distal retention member 4120 has a direction as shown by the arrow
AA in FIG. 25. Similarly, because the second engagement surface
4117 of the actuator 4111 is at an acute angle with respect to the
longitudinal axis A.sub.L, a component of the axial force
transmitted via the second engagement surface 4117 of the actuator
4111 to the first engagement surface 4132 of the second distal
retention member 4130 has a direction as shown by the arrow BB in
FIG. 25. Said another way, a component of the forces exerted by the
actuator 4111 on the first distal retention member 4120 and the
second distal retention member 4130 has a direction that is
substantially normal to the longitudinal axis A.sub.L. These forces
cause the first distal retention member 4120 to slide on the first
engagement surface 4116 of the actuator 4111 causing the first
distal retention member 4120 to move in the direction AA and the
second distal retention member 4130 to slide on the second
engagement surface 4117 of the actuator 4111 causing the second
distal retention member 4130 to move in the direction BB.
[0183] Similarly, when the drive screw 4183 is rotated as indicated
by the arrow CC in FIG. 24, the first engagement surface 4186 of
the tool engagement member 4182 exerts an axial force on the first
engagement surface 4182 of the first proximal retention member 4160
and the second engagement surface 4187 of the tool engagement
member 4182 exerts an axial force on the first engagement surface
4172 of the second proximal retention member 4170. Because the
first engagement surface 4186 of the tool engagement member 4182 is
at an acute angle with respect to the longitudinal axis A.sub.L, a
component of the axial force transmitted via the first engagement
surface 4186 of the tool engagement member 4182 to the first
engagement surface 4162 of the first proximal retention member 4160
has a direction as shown by the arrow AA in FIG. 25. Similarly,
because the second engagement surface 4187 of the tool engagement
member 4182 is at an acute angle with respect to the longitudinal
axis A.sub.L, a component of the axial force transmitted via the
second engagement surface 4187 of the tool engagement member 4182
to the first engagement surface 4172 of the second proximal
retention member 4170 has a direction as shown by the arrow BB in
FIG. 25. Said another way, a component of the forces exerted by the
tool engagement member 4182 on the first proximal retention member
4160 and the second proximal retention member 4170 has a direction
that is substantially normal to the longitudinal axis A.sub.L.
These forces cause the first proximal retention member 4160 to
slide on the first engagement surface 4186 of the tool engagement
member 4182 causing the first proximal retention member 4160 to
move in the direction AA and the second proximal retention member
4170 to slide on the second engagement surface 4187 of the tool
engagement member 4182 causing the second proximal retention member
4170 to move in the direction BB. The dovetail configuration of the
grooves 4124, 4134, 4164, 4174 of the retention members 4120, 4130,
4160, 4170 prevents the retention members 4120, 4130, 4160, 4170
from sliding past the second configuration.
[0184] When the implant 4100 is in the second configuration the
first distal retention member 4120, the second distal retention
member 4130, the first proximal retention member 4160 and/or the
second proximal retention member 4170 are offset from the central
portion 4140 in a direction substantially normal to the
longitudinal axis A.sub.L. Said another way, the outer surface 4121
of the first distal retention member 4120 and/or the outer surface
4161 of the first proximal retention member 4160 are not aligned
with the outer surface 4141 of the central portion 4140 and are
discontinuous with the outer surface 4141 of the central portion
4140. Similarly, the outer surface 4131 of the second distal
retention member 4130 and the outer surface 4171 of the second
proximal retention member 4170 are similarly situated with respect
to the outer surface 4141 of the central portion 4140 when the
implant 4100 is in the second configuration.
[0185] As described above, when the implant 4100 is positioned
between the spinous processes, the implant 4100 can be moved from
the first configuration to the second configuration. In the second
configuration, the first distal retention member 4120 and the first
proximal retention member 4160 are offset from the central portion
4140 to limit lateral movement of the implant 4100 with respect to
the spinous processes. Said another way, the first distal retention
member 4120, the first proximal retention member 4160 and the
central portion 4140 form a saddle, within which a first spinous
process can be disposed. Similarly, in the second configuration,
the second distal retention member 4130 and the second proximal
retention member 4170 are offset from the central portion 4140 to
limit lateral movement of the implant 4100 with respect to the
spinous processes. Said another way, the second distal retention
member 4130, the second proximal retention member 4170 and the
central portion 4140 form a saddle, within which a second spinous
process can be disposed.
[0186] FIGS. 31-44 show an implant 5100, according to an
embodiment. Implant 5100 includes a distal end portion 5110, a
central portion 5140 and a proximal end portion 5180. The central
portion 5140 is coupled between the distal end portion 5110 and the
proximal end portion 5180. The implant 5100 defines a lumen 5146
and includes a drive screw 5183 disposed within the lumen 5146 (see
FIG. 37). The drive screw 5183 has a tool head 5184 configured to
mate with and/or receive a tool for rotating the drive screw 5183,
as further described herein.
[0187] Distal end portion 5110 of implant 5100 includes an actuator
5111, a first distal retention member 5120 and a second distal
retention member 5130. Actuator 5111 includes a tapered surface
5112, a threaded portion 5114 (see FIG. 37), a first engagement
surface 5116, a second engagement surface 5117, a first protrusion
5118 and a second protrusion 5119. The threaded portion 5114 is
disposed fixedly within the lumen 5146 and is configured to receive
the drive screw 5183. In other embodiments, the actuator 5111 can
include a captive nut configured to receive the drive screw
5183.
[0188] The first engagement surface 5116 of the actuator 5111 is
angularly offset from the longitudinal axis A.sub.L of the implant
5100 by an angle between 0 degrees and 90 degrees. The first
engagement surface 5116 includes a first protrusion 5118 having a
trapezoidal cross-sectional shape. In this embodiment, the first
protrusion 5118 is a dovetail protrusion. As described in more
detail below, the first distal retention member 5120 is maintained
in sliding contact with the actuator 5111 via the first protrusion
5118.
[0189] The second engagement surface 5117 of the actuator 5111 is
angularly offset from the longitudinal axis A.sub.L of the implant
5100 by an angle between 0 degrees and 90 degrees. The second
engagement surface 5117 includes a second protrusion 5119 having a
trapezoidal cross-sectional shape. In this embodiment, the second
protrusion 5119 is a dovetail protrusion. As described in more
detail below, the second distal retention member 5130 is maintained
in sliding contact with the actuator 5111 via the second protrusion
5119.
[0190] The first distal retention member 5120 includes an outer
surface 5121, a first engagement surface 5122, a second engagement
surface 5123 opposite the first engagement surface 5122, and a
protrusion 5126. The first distal retention member 5120 defines a
notch 5128 (see FIG. 42) configured to allow the drive screw 5183
to pass through the first distal retention member 5120 when the
implant 5100 is in the first configuration. Said another way, when
the implant 5100 is in the first configuration, the notch 5128 is
aligned with the lumen 5146.
[0191] The protrusion 5126 has a trapezoidal cross-sectional shape
and is configured to be received within a groove of the first
support member 5141. In this embodiment, the second protrusion 5126
is a dovetail protrusion. In this manner, the first distal
retention member 5120 is maintained in sliding contact with the
first support member 5141 via the protrusion 5126. Additionally,
the protrusion 5126 of the first distal retention member 5120 is
configured to engage a portion of the first support member 5141
(see e.g., FIG. 33) to limit movement of the first distal retention
member 5120 relative to the first support member 5141 and/or move
the first support member 5141 in a direction normal to the
longitudinal axis A.sub.L.
[0192] The first engagement surface 5122 of the first distal
retention member 5120 defines a plane that is angularly offset from
the longitudinal axis A.sub.L of the implant 5100 by an angle
between 90 degrees and 180 degrees. Moreover, the first engagement
surface 5122 of the first distal retention member 5120 is
substantially parallel to the first engagement surface 5116 of the
actuator 5111. Accordingly, the first distal retention member 5120
is slidably disposed against the actuator 5111.
[0193] The first engagement surface 5122 of the first distal
retention member 5120 defines a groove 5124. The groove 5124 has a
trapezoidal cross-sectional shape. In this embodiment, the groove
5124 has a dovetail shape that corresponds to the shape of the
first protrusion 5118 of the actuator 5111. The groove 5124 is
configured to slidingly receive the first protrusion 5118 of the
actuator 5111. The undercut of the first protrusion 5118 of the
actuator 5111 slidably maintains the first protrusion 5118 of the
actuator 5111 within the groove 5124. The groove 5124 of the first
engagement surface 5122 and the first protrusion 5118 of the
actuator 5111 collectively allow movement of the first distal
retention member 5120, with respect to the actuator 5111, in a
direction substantially parallel to the first engagement surface
5122 of the first distal retention member 5120. Moreover, the
groove 5124 of the first engagement surface 5122 and the first
protrusion 5118 of the actuator 5111 collectively limit movement of
the first distal retention member 5120, with respect to the
actuator 5111, in a direction substantially normal to the first
engagement surface 5122 of the first distal retention member 5120.
The first engagement surface 5122 of the first distal retention
member 5120 contacts and is configured to slide along the first
engagement surface 5116 of the actuator 5111 when the groove 5124
slides along the first protrusion 5118 of the actuator 5111.
[0194] The second engagement surface 5123 of the first distal
retention member 5120 is substantially parallel to the distal
engagement surface 5143 of the first support member 5141 of the
central portion 5140, and defines a plane that is angularly offset
from the longitudinal axis A.sub.L of the implant 5100 by an angle
between 0 degrees and 90 degrees. Moreover, the angular offset of
the second engagement surface 5123 of the first distal retention
member 5120 is different than the angular offset of the first
engagement surface 5122 of the first distal retention member 5120.
Accordingly, the first distal retention member 5120 is slidably
disposed against the first support member 5141 of the central
portion 5140.
[0195] The second distal retention member 5130 includes an outer
surface 5131, a first engagement surface 5132, a second engagement
surface 5133 opposite the first engagement surface 5132, and a
protrusion 5136. The second distal retention member 5130 defines a
notch 5138 configured to allow the drive screw 5183 to pass the
second distal retention member 5130 when the implant 5100 is in the
first configuration. Moreover, the first engagement surface 5132 of
the second distal retention member 5130 defines a groove 5134. The
second distal retention member 5130 is configured similar to the
first distal retention member 5120, and is therefore not described
in detail.
[0196] The proximal end portion 5180 of implant 5100 includes a
tool engagement member 5182, a first proximal retention member 5160
and a second proximal retention member 5170. Tool engagement member
5182 is configured to mate with and/or receive an insertion tool,
such as those described in U.S. patent application Attorney Docket
No. KYPH-040/02US 305363-2272 entitled "Tools and Methods for
insertion and Removal of Medical Implants," which is incorporated
herein by reference in its entirety. In some embodiments, for
example, an insertion tool can be coupled to an outer surface of
the tool engagement member 5182. In such embodiments, the outer
surface of the tool engagement member 5182 can be configured to
facilitate the docking of the insertion tool (not shown) to the
implant 5100. For example, in some embodiments, the outer surface
of the tool engagement member 5182 can include a lead-in chamfer, a
tapered portion and/or a beveled edge to facilitate the docking of
the insertion tool onto the tool engagement member 5182 of the
implant 5100. Tool engagement member 5182 includes a first
engagement surface 5186, a second engagement surface 5187, a first
protrusion 5188, a second protrusion 5189 and a cap 5185. The cap
5185 is configured to hold the drive screw 5183 in place,
preventing axial movement of the drive screw 5183.
[0197] The first engagement surface 5186 of the tool engagement
member 5182 is angularly offset from the longitudinal axis A.sub.L
of the implant 5100 by an angle between 0 degrees and 90 degrees.
Said another way, the first engagement surface 5186 of the tool
engagement member 5182 is angularly offset from the longitudinal
axis A.sub.L of the implant 5100 by an acute angle. As described in
more detail herein, the angular offset of the first engagement
surface 5186 is associated with moving the implant 5100 between a
first configuration (FIG. 31) and a second configuration (FIG.
32).
[0198] The first protrusion 5188 of the tool engagement member 5182
has an undercut such that the first proximal retention member 5160
can be slidably coupled to the tool engagement member 5182. The
first protrusion 5188 has a trapezoidal cross-sectional shape. In
this embodiment, the first protrusion 5188 is a dovetail
protrusion.
[0199] The second engagement surface 5187 of the tool engagement
member 5182 is similar to the first engagement surface 5186 of the
tool engagement member 5182. The second protrusion 5189 of the tool
engagement member 5182 has an undercut such that the second
proximal retention member 5170 can be slidably coupled to the tool
engagement member 5182. The second protrusion 5189 has a
trapezoidal cross-sectional shape. In this embodiment, the second
protrusion 5189 is a dovetail protrusion.
[0200] The first proximal retention member 5160 includes an outer
surface 4161, a first engagement surface 5162, a second engagement
surface 5163 opposite the first engagement surface 5162, and a
protrusion 5166. The protrusion 5166 of the first proximal
retention member 5160 has an undercut such that the first support
member 5141 of the central portion 5140 can be slidably coupled to
the first proximal retention member 5160. The protrusion 5166 has a
trapezoidal cross-sectional shape. In this embodiment, the
protrusion 5166 is a dovetail protrusion. The first proximal
retention member 5160 defines a notch 5168 configured to allow the
drive screw 5183 to pass through the first proximal retention
member 5160 when the implant 5100 is in the first configuration.
Said another way, when the implant 5100 is in the first
configuration, the notch 5168 is aligned with the lumen 5146.
[0201] The first engagement surface 5162 of the first proximal
retention member 5160 defines a plane that is angularly offset from
the longitudinal axis A.sub.L of the implant 5100 by an angle
between 90 degrees and 180 degrees. Said another way, the first
engagement surface 5162 of the first proximal retention member 5160
defines a plane that is angularly offset from the longitudinal axis
A.sub.L by an obtuse angle. Moreover, the first engagement surface
5162 of the first proximal retention member 5120 is substantially
parallel to the first engagement surface 5186 of the tool
engagement member 5182. Said another way, the angular offset of the
first engagement surface 5162 of the first proximal retention
member 5160 is supplementary with the angular offset of the first
engagement surface 5186 of the tool engagement member 5182.
Accordingly, the first proximal retention member 5160 is slidably
disposed against the tool engagement member 5182.
[0202] Moreover, the first engagement surface 5162 of the first
proximal retention member 5160 defines a groove 5164. The groove
5164 has a trapezoidal cross-sectional shape. In this embodiment,
the groove 5164 has a dovetail shape that corresponds to the shape
of the first protrusion 5188 of the tool engagement member 5182.
The groove 5164 is configured to slidingly receive the first
protrusion 5188 of the tool engagement member 5182. The undercut of
the first protrusion 5188 of the tool engagement member 5182
slidably maintains the first protrusion 5188 of the tool engagement
member 5182 within the groove 5164. The groove 5164 of the first
engagement surface 5162 and the first protrusion 5188 of the tool
engagement member 5182 collectively allow movement of the first
proximal retention member 5160, with respect to the central portion
5140, in a direction substantially parallel to the second
engagement surface 5163 of the first proximal retention member
5160. Moreover, the groove 5164 of the first engagement surface
5162 and the first protrusion 5188 of the tool engagement member
5182 collectively limit movement of the first proximal retention
member 5160, with respect to the central portion 5140, in a
direction substantially normal to the second engagement surface
5163 of the first proximal retention member 5160. The first
engagement surface 5162 of the first proximal retention member 5160
contacts and is configured to slide along the first engagement
surface 5186 of the tool engagement member 5182 when the groove
5164 slides along the first protrusion 5188 of the tool engagement
member 5182.
[0203] The second engagement surface 5163 of the first proximal
retention member 5160 is substantially parallel to the proximal
engagement surface 5142 of the first support member 5141 of the
central portion 5140, and defines a plane that is angularly offset
from the longitudinal axis A.sub.L of the implant 5100 by an angle
between 0 degrees and 90 degrees. Moreover, the angular offset of
the second engagement surface 5163 of the first proximal retention
member 5160 is supplementary with the angular offset of the
proximal engagement surface 5142 of the first support member 5141
of the central portion 5140. Accordingly, the first proximal
retention member 5160 is slidably disposed against the first
support member 5141 of the central portion 5140. In other
embodiments, the plane defined by the second engagement surface
5163 of the first proximal retention member 5160 can be normal to
the longitudinal axis A.sub.L of the implant 5100.
[0204] The second proximal retention member 5170 includes an outer
surface 4171, a first engagement surface 5172, a second engagement
surface 5173 opposite the first engagement surface 5172, and a
protrusion 5176. The protrusion 5176 of the second proximal
retention member 5170 has an undercut such that the second support
member 5151 of the central portion 5140 can be slidably coupled to
the second proximal retention member 5170. The protrusion 5176 has
a trapezoidal cross-sectional shape. In this embodiment, the
protrusion 5176 is a dovetail protrusion. Additionally, the second
proximal retention member 5170 defines a notch 5178 configured to
allow the drive screw 5183 to pass through the second proximal
retention member 5170 when the implant 5100 is in the first
configuration. Moreover, the first engagement surface 5172 of the
second proximal retention member 5170 defines a groove 5174. The
second proximal retention member 5170 is configured similar to the
first proximal retention member 5160.
[0205] The central portion 5140 of implant 5100 includes a first
support member 5141 and a second support member 5151. The first
support member 5141 includes an outer surface 5149, a proximal
engagement surface 5142, and a distal engagement surface 5143. The
first support member 5141 defines a notch 5148 (see FIG. 41)
configured to allow the drive screw 5183 to pass through the first
support member 5141 when the implant 5100 is in the first
configuration. Said another way, when the implant 5100 is in the
first configuration, the notch 5148 is aligned with the lumen
5146.
[0206] The distal engagement surface 5143 of the first support
member 5141 defines a plane that is angularly offset from the
longitudinal axis A.sub.L of the implant 5100 by an angle between
90 degrees and 180 degrees. Moreover, the angular offset of the
distal engagement surface 5143 of the first support member 5141 is
supplementary with the angular offset of the second engagement
surface 5123 of the first distal retention member 5120.
Accordingly, the first support member 5141 is slidably disposed
against the first distal retention member 5120.
[0207] Moreover, the distal engagement surface 5143 of the first
support member 5141 defines a distal groove 5145. The distal groove
5145 is configured to slidingly receive the protrusion 5126 of the
first distal retention member 5120. The undercut of the protrusion
5126 of the first distal retention member 5120 slidably maintains
the protrusion 5126 of the first distal retention member 5120
within the distal groove 5145. The distal engagement surface 5143
of the first support member 5141 contacts and is configured to
slide along the second engagement surface 5123 of the first distal
retention member 5120 when the distal groove 5145 slides along the
protrusion 5126 of the first distal retention member 5120.
[0208] The proximal engagement surface 5142 of the first support
member 5141 defines a plane that is angularly offset from the
longitudinal axis A.sub.L of the implant 5100 by an angle between
90 degrees and 180 degrees. Moreover, the angular offset of the
proximal engagement surface 5142 of the first support member 5141
is supplementary with the angular offset of the second engagement
surface 5163 of the first proximal retention member 5160.
Accordingly, the first support member 5141 is slidably disposed
against the first proximal retention member 5160.
[0209] Moreover, the proximal engagement surface 5142 of the first
support member 5141 defines a proximal groove 5144. The proximal
groove 5144 is configured to slidingly receive the protrusion 5166
of the first proximal retention member 5160. The undercut of the
protrusion 5166 of the first proximal retention member 5160
slidably maintains the protrusion 5166 of the first proximal
retention member 5160 within the proximal groove 5144. The proximal
engagement surface 5142 of the first support member 5141 contacts
and is configured to slide along the second engagement surface 5163
of the first proximal retention member 5160 when the proximal
groove 5144 slides along the protrusion 5166 of the first proximal
retention member 5160.
[0210] Likewise, the second support member 5151 of the central
portion 5140 includes an outer surface 5159, a proximal engagement
surface 5152, and a distal engagement surface 5153. The second
support member 5151 defines a notch 5156 configured to allow the
drive screw 5183 to pass through the second support member 5151
when the implant 5100 is in the first configuration. The proximal
engagement surface 5152 defines a proximal groove 5154 and the
distal engagement surface 5153 defines a distal groove 5155. The
second support member 5151 is configured similar to the first
support member 5141.
[0211] Implant 5100 has a first configuration and a second
configuration. FIG. 31 shows the implant 5100 in a first
configuration. When the implant 5100 is in the first configuration,
the proximal end portion 5180, the distal end portion 5110 and the
central portion 5140 are substantially coaxial (i.e., substantially
share a common longitudinal axis). Said another way, when the
implant 5100 is in the first configuration, the outer surface 5121
of the first distal retention member 5120 and the outer surface
5161 of the first proximal retention member 5160 are substantially
aligned with the outer surface 5149 of the first support member
5141 of the central portion 5140. Said another way, the outer
surface 5121 of the first distal retention member 5120, the outer
surface 5161 of the first proximal retention member 5160, and the
outer surface 5149 of the first support member 5141 of the central
portion 5140 form a substantially continuous surface. Said yet
another way, the outer surface 5121 of the first distal retention
member 5120 and the outer surface 5161 of the first proximal
retention member 5160 are flush with the outer surface 5149 of the
first support member 5141 of the central portion 5140. Similarly,
the outer surface 5131 of the second distal retention member 5130
and the outer surface 5171 of the second proximal retention member
5170 are similarly aligned with the outer surface 5159 of the
second support member 5151 of the central portion 5140 when the
implant 5100 is in the first configuration.
[0212] The implant 5100 can be moved between the first
configuration and the second configuration as illustrated in FIG.
32. To move the implant 5100 from the first configuration to the
second configuration, the drive screw 5183 is rotated. When the
drive screw 5183 is rotated as indicated by the arrow CC in FIG.
31, the drive screw 5183 pulls the actuator 5111 and the tool
engagement member 5182 toward the central portion 5140. The first
engagement surface 5116 of the actuator 5111 exerts an axial force
on the first engagement surface 5122 of the first distal retention
member 5120 and the second engagement surface 5117 of the actuator
5111 exerts an axial force on the first engagement surface 5132 of
the second distal retention member 5130. Because the first
engagement surface 5116 of the actuator 5111 is at an acute angle
with respect to the longitudinal axis A.sub.L, a component of the
axial force transmitted via the first engagement surface 5116 of
the actuator 5111 to the first engagement surface 5122 of the first
distal retention member 5120 has a direction as shown by the arrow
AA in FIG. 31. Similarly, because the second engagement surface
5117 of the actuator 5111 is at an acute angle with respect to the
longitudinal axis A.sub.L, a component of the axial force
transmitted via the second engagement surface 5117 of the actuator
5111 to the first engagement surface 5132 of the second distal
retention member 5130 has a direction as shown by the arrow BB in
FIG. 31. Said another way, a component of the forces exerted by the
actuator 5111 on the first distal retention member 5120 and the
second distal retention member 5130 has a direction that is
substantially normal to the longitudinal axis A.sub.L. These forces
cause the first distal retention member 5120 to slide on the first
engagement surface 5116 of the actuator 5111 causing the first
distal retention member 5120 to move in the direction AA and the
second distal retention member 5130 to slide on the second
engagement surface 5117 of the actuator 5111 causing the second
distal retention member 5130 to move in the direction BB.
[0213] Similarly, when the drive screw 5183 is rotated as indicated
by the arrow CC in FIG. 31, the first engagement surface 5186 of
the tool engagement member 5182 exerts an axial force on the first
engagement surface 5182 of the first proximal retention member 5160
and the second engagement surface 5187 of the tool engagement
member 5182 exerts an axial force on the first engagement surface
5172 of the second proximal retention member 5170. Because the
first engagement surface 5186 of the tool engagement member 5182 is
at an acute angle with respect to the longitudinal axis A.sub.L, a
component of the axial force transmitted via the first engagement
surface 5186 of the tool engagement member 5182 to the first
engagement surface 5162 of the first proximal retention member 5160
has a direction as shown by the arrow AA in FIG. 31. Similarly,
because the second engagement surface 5187 of the tool engagement
member 5182 is at an acute angle with respect to the longitudinal
axis A.sub.L, a component of the axial force transmitted via the
second engagement surface 5187 of the tool engagement member 5182
to the first engagement surface 5172 of the second proximal
retention member 5170 has a direction as shown by the arrow BB in
FIG. 31. Said another way, a component of the forces exerted by the
tool engagement member 5182 on the first proximal retention member
5160 and the second proximal retention member 5170 has a direction
that is substantially normal to the longitudinal axis A.sub.L.
These forces cause the first proximal retention member 5160 to
slide on the first engagement surface 5186 of the tool engagement
member 5182 causing the first proximal retention member 5160 to
move in the direction AA and the second proximal retention member
5170 to slide on the second engagement surface 5187 of the tool
engagement member 5182 causing the second proximal retention member
5170 to move in the direction BB.
[0214] As the first proximal retention member 5160 and the first
distal retention member 5120 move in direction AA, the protrusions
5166, 5126 of the first proximal retention member 5160 and the
first distal retention member 5120, respectively, contact the upper
surface of the proximal groove 5144 and the distal groove 5145 of
the first support member 5141 respectively, causing the first
support member 5141 to move in the direction AA. In the second
configuration, as seen in FIG. 33, the first support member 5141 is
displaced from its position in the first configuration in the
direction AA. Likewise, as the second proximal retention member
5170 and the second distal retention member 5130 move in direction
BB, the protrusions 5176, 5136 of the second proximal retention
member 5170 and the second distal retention member 5130,
respectively, contact the upper surface of the proximal groove 5154
and the distal groove 5155 of the second support member 5151
respectively, causing the second support member 5151 to move in the
direction BB. In the second configuration, as seen in FIG. 33, the
second support member 5151 is displaced from its position in the
first configuration in the direction BB. In this manner, the first
support member 5141 and the second support member 5151 can distract
the adjacent spinous processes.
[0215] When the implant 5100 is in the second configuration the
first distal retention member 5120, the second distal retention
member 5130, the first proximal retention member 5160 and/or the
second proximal retention member 5170 are offset from the central
portion 5140. Said another way, the outer surface 5121 of the first
distal retention member 5120 and/or the outer surface 5161 of the
first proximal retention member 4160 are not aligned with the outer
surface 5149 of the first support member 5141 of the central
portion 5140 and are discontinuous with the outer surface 5149 of
the first support member 5141 of the central portion 5140.
Similarly, the outer surface 5131 of the second distal retention
member 5130 and the outer surface 5171 of the second proximal
retention member 5170 are similarly situated with respect to the
outer surface 5159 of the second support member 5151 of the central
portion 5140 when the implant 5100 is in the second configuration.
Moreover, when the implant is in the second configuration, the
first support member 5141 of the central portion 5140 and the
second support member 5151 of the central portion 5140 are offset
from the longitudinal axis A.sub.L in a direction substantially
normal to the longitudinal axis A.sub.L.
[0216] In use, implant 5100 is inserted percutaneously between a
pair of adjacent spinous processes (not shown in FIGS. 31-44), in
the first configuration. For example, a medical practitioner can
insert the implant 5100 percutaneously (e.g., through a cannula,
over a guide wire, or the like) into a body of a patient. An
insertion tool, such as those described in U.S. patent application
Attorney Docket No. KYPH-040/02US 305363-2272 entitled "Tools and
Methods for insertion and Removal of Medical Implants," which is
incorporated herein by reference in its entirety, can be used to
insert the implant 5100 into a body of a patient. The insertion
tool is configured to be removably coupled to the tool engagement
member 5182. In this manner, the insertion tool retains the implant
5100. Said another way, the insertion tool limits the rotational
movement of the implant 5100, with respect to the insertion tool,
about the longitudinal axis A.sub.L and limits the axial movement
of the implant 5100, with respect to the insertion tool, about the
longitudinal axis A.sub.L. The insertion tool has an actuator
configured to be inserted into the tool head 5184 of the drive
screw 5183. The actuator of the insertion tool is configured to
rotate the drive screw 5183 about the longitudinal axis A.sub.L,
without rotating the other components of the implant 5100. Said
another way, the insertion tool limits rotational movement of the
tool engagement member 5182 while rotating the drive screw 5183
about the longitudinal axis A.sub.L.
[0217] When inserting the implant 5100 into a body of a patient,
the distal end portion 5110 is inserted first and is moved past the
spinous processes until the central portion 5140 is positioned
between the spinous processes. In this manner, the central portion
5140 of the implant 5100 can distract and/or maintain a minimal
spacing between the adjacent spinous processes. The distance
between the top surface and the bottom surface of the central
portion 5140 can be slightly smaller than the space between the
spinous processes to account for surrounding ligaments and tissue.
Similar to implant 100, in some embodiments, the central portion
5140 in its first configuration directly contacts the spinous
processes between which it is positioned.
[0218] Once between the spinous processes, the implant 5100 can be
moved from the first configuration to the second configuration. In
the second configuration, the first and second proximal retention
members 5160, 5170 and the first and second distal retention
members 5120, 5130 are offset from the actuator 5111 and the tool
engagement member 5182, and positioned to limit lateral movement of
the implant 5100 with respect to the spinous processes. Said
another way, the first distal retention member 5120, the first
proximal retention member 5160 and the central portion 5140 form a
saddle, within which a first spinous process can be disposed.
Similarly, the second distal retention member 5130, the second
proximal retention member 5170 and the central portion 5140 form a
saddle, within which a second spinous process can be disposed. The
first and second proximal retention members 5160, 5170 and the
first and second distal retention members 5120, 5130 can also
further distract the spinous processes. The proximal retention
member 5160 and the distal retention member 5120 are configured to
engage the superior spinous processes (i.e., either directly or
through surrounding tissue) and the second proximal retention
member 5170 and the second distal retention member 5130 are
configured to engage the inferior spinous process (i.e., either
directly or through surrounding tissue) in the second
configuration. Additionally, in the second configuration, the first
support member 5141 of the central portion 5140 and the second
support member 5151 of the central portion are offset from the
actuator 5111 and the tool engagement member 5182 and positioned to
distract the spinous processes. Once in the second configuration,
the implant 5100 can be released from the insertion tool and the
insertion tool can be removed from the patient's body.
[0219] To remove from and/or reposition the implant 5100 within the
body, the drive screw 5183 is rotated as indicated by the arrow DD
in FIG. 31, by for example, a removal tool (may be similar to an
insertion tool). Rotating the drive screw in direction DD, causes
the dovetail configuration of the protrusions 5118, 5119 of the
insertion member 1111 and the dovetail configurations of the
protrusions 5188, 5189 of the tool engagement member 5182 to pull
the distal retention members 5120, 5130 and the proximal retention
members 5160, 5170 back into the first configuration. This causes
the dovetail configurations of the protrusions 5126, 5136 of the
distal retention members 5120, 5130 and the dovetail configurations
of the protrusions 5166, 5176 of the proximal retention members
5160, 5170 to pull the support members 5141, 5151 back into the
first configuration. After the implant 5100 is in the first
configuration, a medical practitioner can remove from and/or
reposition the implant 5100 within the body.
[0220] Although the implant 5100 is shown is being movable between
a first configuration (FIG. 31) and a second configuration (FIG.
32), the implant 5100 can be maintained in any number of different
configurations. For example, the implant 5100 can be maintained in
any suitable configuration between the first configuration and the
second configuration. Said another way, the implant 5100 can be
placed in an infinite number of different configurations between
the first configuration and the second configuration. Thus, the
spinous processes can be distracted by the first support member
5141 and the second support member 5151 by any desired amount
within a predetermined range. In this manner, a single implant 5100
can be used to treat a wide range of conditions and/or locations
within the body requiring different amounts of distraction.
Moreover, this arrangement allows the amount of distraction to be
varied in situ over time.
[0221] For example, in some embodiments, the amount of distraction
can be varied within a range of approximately 10 mm to 16 mm.
Within this range, the size of the central portion 5140 can be
adjusted to any desired amount by rotating the drive screw 5183 a
predetermined amount, as described above. In other embodiments, the
range of distraction can be approximately 3 mm (e.g., a range from
10 mm to 13 mm, a range from 12 mm to 15 mm, or the like). In yet
other embodiments, the range of distraction can be approximately 2
mm (e.g., a range from 10 mm to 12 mm, a range from 12 mm to 14 mm,
or the like).
[0222] Although the implants shown and described above are
configured to be disposed within a space between adjacent spinous
processes, in other embodiments an implant can be configured to be
disposed within a spinal disc space, for example, to stabilize
and/or distract a spinal segment after disc material is removed
from the disc space. In some embodiments, for example, an apparatus
includes a spacer and an actuator. The spacer has a first spacer
member configured to engage an endplate of a first vertebra and a
second spacer member configured to engage an endplate of a second
vertebra. The second vertebra can be adjacent the first vertebra.
The actuator has a first actuator member and a second actuator
member coupled to the first actuator member. The first actuator
member is matingly and movably coupled to the first spacer member.
Similarly, the first actuator is matingly and movably coupled to
the second spacer member. The second actuator member is matingly
and movably coupled to the first spacer member. Similarly, the
second actuator member is matingly and movably coupled to the
second spacer member. The actuator is configured to move the spacer
between a first configuration and a second configuration. The first
spacer member is in contact with the second spacer member when the
spacer is in the first configuration. The first spacer member is
spaced apart from the second spacer member by a non-zero distance
when the spacer is in the second configuration. This arrangement
can, for example, allow for the insertion of bone material and/or
bone growth enhancing substances between the first spacer member
and the second spacer member.
[0223] In some embodiments, a disc implant can include one or more
components having mating surfaces that are non-parallel to and
non-normal to a longitudinal axis of the implant. For example, in
some embodiments, a disc implant can include a spacer and an
actuator. The spacer defines a longitudinal axis and has a first
spacer member and a second spacer member. The first spacer member
is configured to engage an endplate of a first vertebra, and has a
first surface and a second surface. An axis within a plane defined
by the first surface of the first spacer member is non-parallel to
and non-normal to the longitudinal axis. An axis within a plane
defined by the second surface of the first spacer member is
non-parallel to and non-normal to the longitudinal axis. The second
spacer member is configured to engage an endplate of a second
vertebra, the second vertebra being adjacent the first vertebra.
The second spacer member has a first surface and a second surface.
An axis within a plane defined by the first surface of the second
spacer member is non-parallel to and non-normal to the longitudinal
axis. An axis within a plane defined by the second surface of the
second spacer member is non-parallel to and non-normal to the
longitudinal axis. The actuator has a first actuator member and a
second actuator member movably coupled to the first actuator
member. A first surface of the first actuator member is in contact
with and substantially parallel to the first surface of the first
spacer member. A second surface of the first actuator member is in
contact with and substantially parallel to the first surface of the
second spacer member. A first surface of the second actuator member
is in contact with and substantially parallel to the second surface
of the first spacer member. A second surface of the second actuator
member is in contact with and substantially parallel to the second
surface of the second spacer member. The actuator is configured to
move the spacer between a first configuration and a second
configuration. The first spacer member is in contact with the
second spacer member when the spacer is in the first configuration.
The first spacer member is spaced apart from the second spacer
member by a non-zero distance when the spacer is in the second
configuration.
[0224] In some embodiments, an apparatus includes a spacer and an
actuator. The spacer defines a longitudinal axis and has a first
spacer member configured to engage an endplate of a first vertebra,
and a second spacer member configured to engage an endplate of a
second vertebra. The first spacer member has a first surface and a
second surface. The second spacer member has a first surface and a
second surface. The actuator has a first actuator member and a
second actuator member movably coupled to the first actuator
member. A first surface of the first actuator member is matingly
and movably coupled to the first surface of the first spacer
member. A second surface of the first actuator is matingly and
movably coupled to the first surface of the second spacer member. A
first surface of the second actuator member is matingly and movably
coupled to the second surface of the first spacer member. A second
surface of the second actuator member is matingly and movably
coupled to the second surface of the second spacer member. The
actuator is configured to move the spacer between a first
configuration and a second configuration. The spacer has a first
size along a first axis substantially normal to the longitudinal
axis and a second size along a second axis substantially normal to
the longitudinal axis and substantially normal to the first axis.
The first size when the spacer is in the second configuration is
greater than the first size when the spacer is in the first
configuration. The second size when the spacer is in the second
configuration is substantially equal to the second size when the
spacer is in the first configuration.
[0225] FIGS. 45 and 46 are schematic illustrations of an implant
400 according to an embodiment, in a first configuration and a
second configuration, respectively. As shown, the implant 400 is
configured to be disposed within a disc space DS. The disc space DS
is bounded by a first endplate EP1, a second endplate EP2, and an
annulus fibrosis AF of the disc (shown by the dashed lines in FIGS.
45 and 46). The implant 400 includes a spacer 440 and an actuator
405. The spacer 440 has a first spacer member 441 and a second
spacer member 451, and defines a center line C.sub.L. The center
line C.sub.L can be, for example, parallel to a longitudinal axis
of the spacer 440. As shown in FIG. 46, the first spacer member 441
is configured to engage the first endplate EP1. Similarly, the
second spacer member 551 is configured to engage the second
endplate EP2.
[0226] The actuator 405 has a first actuator member 411 and a
second actuator member 482 coupled to the first actuator member
411. As shown in FIGS. 45 and 46, the first actuator member 411 is
matingly and movably coupled to the first spacer member 441 and the
second spacer member 451. Similarly, the second actuator member 482
is matingly and movably coupled to the first spacer member 441 and
the second spacer member 451. The first actuator member 411 and/or
the second actuator member 482 can be matingly coupled to the first
spacer member 441 and/or the second spacer member 451 in any
suitable manner. For example, in some embodiments, the first
actuator member 411 and/or the second actuator member 482 can
include a dovetail protrusion and/or dovetail groove, of the types
shown and described above, configured to matingly engage a dovetail
protrusion and/or dovetail groove of the first spacer member 441
and/or the second spacer member 451. In this manner, the first
spacer member 441 and/or the second spacer member 451 can be
maintained in movable contact with the first actuator member 411
and/or the second actuator member 482. Similarly stated, such an
arrangement allows the first spacer member 441 and/or the second
spacer member 451 to remain in sliding contact with the first
actuator member 411 and/or the second actuator member 482 over a
range of motion. Said another way, such an arrangement prevents
movement of the first spacer member 441 and/or the second spacer
member 451 in a first direction relative to the first actuator
member 411 and/or the second actuator member 482 while allowing
movement of the first spacer member 441 and/or the second spacer
member 451 in a second direction relative to the first actuator
member 411 and/or the second actuator member 482.
[0227] The actuator 405 is configured to move the spacer 440
between a first configuration (FIG. 45) and a second configuration
(FIG. 46). The actuator 405 can move the spacer 440 between the
first configuration and the second configuration by any suitable
mechanism. For example, in some embodiments, the actuator 405 can
include a biasing member configured to move the spacer 440 between
the first configuration and the second configuration. In other
embodiments, the actuator 405 can move between a first position and
a second position (not shown in FIGS. 45 and 46) to move the spacer
440 between the first configuration and the second configuration.
In yet other embodiments, the first actuator member 411 can be
configured to move relative to the second actuator member 482 to
move the spacer 440 between the first configuration and the second
configuration.
[0228] As shown in FIG. 45, the first spacer member 441 is in
contact with the second spacer member 451 when the spacer 440 is in
the first configuration. More particularly, a surface 447 of the
first spacer member 441 is in contact with a surface 457 of the
second spacer member 451 when the spacer 440 is in the first
configuration. Moreover, the spacer 440 has a first size S1 along
an axis substantially normal to the center line C.sub.L (e.g., a
vertical axis as shown in FIG. 45) when the spacer 440 is in the
first configuration.
[0229] When the actuator 405 moves the spacer 440 from the first
configuration to the second configuration, the first spacer member
441 moves relative to the second spacer member 451 in a direction
substantially normal to the center line C.sub.L, as shown by the
arrow GGG in FIG. 46. Similarly stated, when the actuator 405 moves
the spacer 440 from the first configuration to the second
configuration, the second spacer member 451 moves relative to the
first spacer member 441 in a direction substantially normal to the
center line C.sub.L, as shown by the arrow HHH in FIG. 46. Said
another way, when the actuator 405 moves the spacer 440 from the
first configuration to the second configuration, the first spacer
member 441 is moved apart from the second spacer member 451.
[0230] Accordingly, when the spacer 440 is in the second
configuration, the first spacer member 441 is spaced apart from the
second spacer member 451 by a non-zero distance. Said another way,
a lower portion of the surface 447 of the first spacer member 441
is spaced apart from an upper portion of the surface 457 of the
second spacer member 451 by a non-zero distance d when the spacer
440 is in the second configuration. Said yet another way, the first
spacer member 441 and the second spacer member 451 collectively
define an opening 450 when the spacer 440 is in the second
configuration. In this manner, bone material and/or bone growth
enhancing substances can be disposed between the first spacer
member 441 and the second spacer member 451 (e.g., within the
opening 450) when the spacer 440 is in the second configuration.
Also, bone growth can occur through the opening 450, promoting
better fusion between the end plate EP1 and the end plate EP2.
[0231] Moreover, the spacer 440 has a second size S2 along the axis
substantially normal to the center line C.sub.L, greater than the
size S1, when the spacer 440 is in the second configuration.
Similarly stated, the size of the spacer 440 along at least one
axis is increased when the spacer 440 is moved from the first
configuration to the second configuration. Accordingly, in use, the
implant 400 can be inserted into the disc space DS when the implant
400 is in the first configuration (see e.g., FIG. 45). For example,
a user can insert the implant 400 percutaneously (e.g., through a
cannula, over a guide wire, or the like) into a body of a patient.
In some embodiments, a tool, such as those described in U.S. patent
application Attorney Docket No. KYPH-040/02US 305363-2272 entitled
"Tools and Methods for insertion and Removal of Medical Implants,"
which is incorporated herein by reference in its entirety can be
used to insert the implant 400 into a body of a patient and/or
actuate the implant 400, as described above.
[0232] In some embodiments, the spacer 440 can be repeatedly moved
between the first configuration and the second configuration. In
this manner, a user can remove the implant 400 from and/or
reposition the implant 400 within the body in a minimally-invasive
manner.
[0233] In use, implant 400 can be inserted percutaneously into a
disc space (not shown). In this manner, the implant 400 can be
used, for example, as a fusion cage. The implant 400 can be
inserted when in the first configuration, by, for example, an
insertion tool as shown and described in U.S. patent application
Attorney Docket No. KYPH-040/02US 305363-2272 entitled "Tools and
Methods for insertion and Removal of Medical Implants," which is
incorporated herein by reference in its entirety. Once in the disc
space, the implant 400 can be moved from the first configuration to
the second configuration. In this manner, the first spacer member
441 and the second spacer member 451 can distract and/or maintain a
minimal spacing of the disc space. More particularly, the first
spacer member 441 and the second spacer member 451 can contact the
vertebral endplates to stabilize the spinal segment within which
the implant 400 is disposed.
[0234] FIGS. 47-60 show an implant 1200, according to an
embodiment. Implant 1200 includes a distal end portion 1210, a
central portion 1240 and a proximal end portion 1280. The central
portion 1240 is disposed between the distal end portion 1210 and
the proximal end portion 1280. The implant 1200 defines a lumen
1246 (see FIG. 54) and includes a drive screw 1283 disposed within
the lumen 1246. The drive screw 1283 has a tool head 1284
configured to mate with and/or receive a tool for rotating the
drive screw 1283, as described in U.S. patent application Attorney
Docket No. KYPH-040/02US 305363-2272 entitled "Tools and Methods
for insertion and Removal of Medical Implants," which is
incorporated herein by reference in its entirety.
[0235] The distal end portion 1210 of implant 1200 includes an
actuator 1211, a first distal intermediate member 1220 and a second
distal intermediate member 1230. Actuator 1211 includes a tapered
surface 1212, a threaded portion 1214 (see FIG. 55), a first
engagement surface 1216, a second engagement surface 1217, a first
protrusion 1218 and a second protrusion 1219. The threaded portion
1214 is disposed fixedly within the lumen 1246 and is configured to
receive the drive screw 1283. In other embodiments, the insertion
member can include a captive nut configured to receive the drive
screw 1283.
[0236] The first engagement surface 1216 of the actuator 1211 is
angularly offset from the longitudinal axis A.sub.L of the implant
1200 by an angle between 0 degrees and 90 degrees. Similarly, the
second engagement surface 1217 of the actuator 1211 is angularly
offset from the longitudinal axis A.sub.L of the implant 1200 by an
angle between 0 degrees and 90 degrees. As described above, the
angular offset of the engagement surfaces 1216 and 1217 are
associated with moving the implant 1200 between a first
configuration (FIG. 47) and a second configuration (FIG. 48). More
particularly, the angular offsets of the engagement surfaces 1216
and 1217 are associated with the force to move the implant 1200
between the first configuration and the second configuration. The
angular offsets of the of the engagement surfaces 1216 and 1217 are
also associated with the distance through which various components
of the implant 1200 are moved when the implant 1200 is moved
between the first configuration and the second configuration.
Although the engagement surfaces 1216 and 1217 are shown and
described as being non-parallel to and non-normal to the
longitudinal axis A.sub.L of the implant 1200, in other
embodiments, the engagement surfaces 1216 and 1217 can be
substantially parallel to or substantially normal to the
longitudinal axis A.sub.L of the implant 1200.
[0237] As shown in FIG. 57, the first protrusion 1218 of the
actuator 1211 has an undercut such that the first distal
intermediate member 1220 can be slidably coupled to the actuator
1211. More particularly, the first protrusion 1218 has a
trapezoidal cross-sectional shape. In this embodiment, the first
protrusion 1218 is a dovetail protrusion. Similarly, the second
protrusion 1219 of the actuator 1211 has an undercut such that the
second distal intermediate member 1230 can be slidably coupled to
the actuator 1211. More particularly, the second protrusion 1219
has a trapezoidal cross-sectional shape. In this embodiment, the
second protrusion 1219 is a dovetail protrusion.
[0238] The first distal intermediate member 1220 includes a first
engagement surface 1222, a second engagement surface 1223 opposite
the first engagement surface 1222 and a protrusion 1226. The first
distal intermediate member 1220 defines a notch 1228 (see FIG. 59)
configured to allow the drive screw 1283 to pass through the first
distal intermediate member 1220 when the implant 1200 is in the
first configuration. Said another way, when the implant 1200 is in
the first configuration, the notch 1228 is aligned with the lumen
1246.
[0239] The protrusion 1226 of the first distal intermediate member
1220 extends from the second engagement surface 1223 and has a
trapezoidal cross-sectional shape. In this embodiment, the
protrusion 1226 is a dovetail protrusion configured to matingly and
movably couple the first central support member 1241 of the central
portion 1240 to the first distal intermediate member 1220.
[0240] The first engagement surface 1222 of the first distal
intermediate member 1220 defines a plane that is angularly offset
from the longitudinal axis A.sub.L of the implant 1200 by an angle
between 90 degrees and 180 degrees. Moreover, the first engagement
surface 1222 of the first distal intermediate member 1220 is
substantially parallel to the engagement surface 1216 of the
actuator 1211. Said another way, the angular offset of the first
engagement surface 1222 of the distal retention member 1220 is
supplementary with the angular offset of the engagement surface
1216 of the actuator 1211.
[0241] The first engagement surface 1222 of the first distal
intermediate member 1220 defines a groove 1224 having a trapezoidal
cross-sectional shape. In this embodiment, the groove 1224 has a
dovetail shape that corresponds to the shape of the first
protrusion 1218 of the actuator 1211. Accordingly, the first distal
intermediate member 1220 and the actuator 1211 are matingly and
movably coupled by the groove 1224 and the first protrusion 1218.
Similarly stated, the groove 1224 and the first protrusion 1218 are
collectively configured to limit movement of the first distal
intermediate member 1220 relative to the actuator 1211 in a
direction substantially normal to the first engagement surface 1222
of the first distal intermediate member 1220. Moreover, the groove
1224 and the first protrusion 1218 of the actuator 1211
collectively allow movement of the first distal intermediate member
1220 relative to the actuator 1211 in a direction substantially
parallel to the first engagement surface 1222 of the first distal
intermediate member 1220.
[0242] The second engagement surface 1223 of the first distal
intermediate member 1220 defines a plane that is angularly offset
from the longitudinal axis A.sub.L of the implant 1200 by an angle
between 0 degrees and 90 degrees. Accordingly, the first distal
intermediate member 1220 is slidably disposed against the first
central support member 1241 of the central portion 1240.
[0243] The second distal intermediate member 1230 includes a first
engagement surface 1232, a second engagement surface 1233 opposite
the first engagement surface 1232, and a protrusion 1236. The
protrusion 1236 of the second distal intermediate member 1230
extends from the second engagement surface 1233 and has a
trapezoidal cross-sectional shape. In this embodiment, the
protrusion 1236 is a dovetail protrusion configured to matingly and
movably couple the second central support member 1251 of the
central portion 1240 to the second distal intermediate member
1230.
[0244] Additionally, the second distal intermediate member 1230
defines a notch 1238 configured to allow the drive screw 1283 to
pass through the second distal intermediate member 1230 when the
implant 1200 is in the first configuration. Moreover, the first
engagement surface 1232 of the second distal intermediate member
1230 defines a groove 1234. The second distal intermediate member
1230 is configured similar to the first distal intermediate member
1220, and is therefore not described in detail herein.
[0245] Proximal end portion 1280 of implant 1200 includes a tool
engagement member 1282, a first proximal intermediate member 1260
and a second proximal intermediate member 1270. Tool engagement
member 1282 is configured to mate with and/or receive an insertion
tool, such as those described herein. Tool engagement member 1282
includes a first engagement surface 1286, a second engagement
surface 1287, a first protrusion 1288 and a second protrusion
1289.
[0246] The first engagement surface 1286 of the tool engagement
member 1282 is angularly offset from the longitudinal axis A.sub.L
of the implant 1200 by an angle between 0 degrees and 90 degrees.
Similarly, the second engagement surface 1287 of the tool
engagement member 1282 is angularly offset from the longitudinal
axis A.sub.L of the implant 1200 by an angle between 0 degrees and
90 degrees.
[0247] The first protrusion 1288 of the tool engagement member 1282
has an undercut such that the first proximal intermediate member
1260 can be slidably coupled to the tool engagement member 1282.
More particularly, the first protrusion 1288 has a trapezoidal
cross-sectional shape. In this embodiment, the first protrusion
1288 is a dovetail protrusion. Similarly, the second protrusion
1289 of the tool engagement member 1282 has an undercut such that
the second proximal intermediate member 1270 can be slidably
coupled to the tool engagement member 1282.
[0248] The first proximal intermediate member 1260 includes a first
engagement surface 1262, a second engagement surface 1263 opposite
the first engagement surface 1262 and a protrusion 1266. The first
proximal intermediate member 1260 defines a notch 1268 configured
to allow the drive screw 1283 to pass through the first proximal
intermediate member 1260 when the implant 1200 is in the first
configuration. Said another way, when the implant 1200 is in the
first configuration, the notch 1268 is aligned with the lumen
1246.
[0249] The protrusion 1266 of the first proximal intermediate
member 1260 extends from the second engagement surface 1263 and has
a trapezoidal cross-sectional shape. In this embodiment, the
protrusion 1266 is a dovetail protrusion configured to matingly and
movably couple the first central support member 1241 of the central
portion 1240 to the first proximal intermediate member 1260.
[0250] The first engagement surface 1262 of the first proximal
intermediate member 1260 defines a plane that is angularly offset
from the longitudinal axis A.sub.L of the implant 1200 by an angle
between 90 degrees and 180 degrees. Moreover, the first engagement
surface 1262 of the first proximal intermediate member 1260 is
substantially parallel to the first engagement surface 1286 of the
tool engagement member 1282.
[0251] The first engagement surface 1262 of the first proximal
intermediate member 1260 defines a groove 1264 having a trapezoidal
cross-sectional shape. In this embodiment, the groove 1264 has a
dovetail shape that corresponds to the shape of the first
protrusion 1288 of the tool engagement member 1282. Accordingly,
the first proximal intermediate member 1260 and the tool engagement
member 1282 are matingly and movably coupled by the groove 1264 and
the first protrusion 1288. Similarly stated, the groove 1264 and
the first protrusion 1288 are collectively configured to limit
movement of the first proximal intermediate member 1260 relative to
the tool engagement member 1282 in a direction substantially normal
to the first engagement surface 1262 of the first proximal
intermediate member 1260. Moreover, the groove 1264 and the first
protrusion 1288 of the tool engagement member 1282 collectively
allow movement of the first proximal intermediate member 1260
relative to the tool engagement member 1282 in a direction
substantially parallel to the first engagement surface 1262 of the
first proximal intermediate member 1260.
[0252] The second engagement surface 1263 of the first proximal
intermediate member 1260 defines a plane that is angularly offset
from the longitudinal axis A.sub.L of the implant 1200 by an angle
between 0 degrees and 90 degrees. Accordingly, the first proximal
intermediate member 1260 is slidably disposed against the first
central support member 1241 of the central portion 1240.
[0253] The second proximal intermediate member 1270 includes a
first engagement surface 1272, a second engagement surface 1273
opposite the first engagement surface 1272, and a protrusion 1276.
The protrusion 1276 of the second proximal intermediate member 1270
extends from the second engagement surface 1273 and has a
trapezoidal cross-sectional shape. In this embodiment, the
protrusion 1276 is a dovetail protrusion configured to matingly and
movably couple the second central support member 1251 of the
central portion 1240 to the second proximal intermediate member
1270.
[0254] Additionally, the second proximal intermediate member 1270
defines a notch configured to allow the drive screw 1283 to pass
through the second proximal intermediate member 1270 when the
implant 1200 is in the first configuration. Moreover, the first
engagement surface 1272 of the second proximal intermediate member
1270 defines a groove. The second proximal intermediate member 1270
is configured similar to the first proximal intermediate member
1260, and is therefore not described in detail herein.
[0255] The central portion 1240 of implant 1200 includes a first
central support member 1241 and a second central support member
1251. The first central support member 1241 includes a proximal
engagement surface 1242 and a distal engagement surface 1243. The
first central support member 1241 defines a notch 1246 configured
to allow the drive screw 1283 to pass through the first central
support member 1241 when the implant 1200 is in the first
configuration. Said another way, when the implant 1200 is in the
first configuration, the notch 1246 is aligned with the lumen
1246.
[0256] The distal engagement surface 1243 of the first central
support member 1241 defines a plane that is angularly offset from
the longitudinal axis A.sub.L of the implant 1200 by an angle
between 90 degrees and 180 degrees. Moreover, the angular offset of
the distal engagement surface 1243 of the first central support
member 1241 is supplementary with the angular offset of the second
engagement surface 1223 of the first distal intermediate member
1220. Accordingly, the first central support member 1241 is
slidably disposed against the first distal intermediate member
1220.
[0257] Moreover, the distal engagement surface 1243 of the first
central support member 1241 defines a distal groove 1245. The
distal groove 1245 is configured to receive and to slide along the
protrusion 1226 of the first distal intermediate member 1220. The
trapezoidal cross-section of the protrusion 1226 of the first
distal intermediate member 1220 slidably maintains the protrusion
1226 of the first distal intermediate member 1220 within the distal
groove 1245. The distal engagement surface 1243 of the first
central support member 1241 contacts and is configured to slide
along the second engagement surface 1223 of the first distal
intermediate member 1220 when the distal groove 1245 slides along
the protrusion 1226 of the first distal intermediate member
1220.
[0258] The proximal engagement surface 1242 of the first central
support member 1241 defines a plane that is angularly offset from
the longitudinal axis A.sub.L of the implant 1200 by an angle
between 90 degrees and 180 degrees. Moreover, the angular offset of
the proximal engagement surface 1242 of the first central support
member 1241 is supplementary with the angular offset of the second
engagement surface 1263 of the first proximal intermediate member
1260. Accordingly, the first central support member 1241 is
slidably disposed against the first proximal intermediate member
1260.
[0259] Moreover, the proximal engagement surface 1242 of the first
central support member 1241 defines a proximal groove 1244. The
proximal groove 1244 is configured to receive and to slide along
the protrusion 1266 of the first proximal intermediate member 1260.
The trapezoidal cross-section of the protrusion 1266 of the first
proximal intermediate member 1260 slidably maintains the protrusion
1266 of the first proximal intermediate member 1260 within the
proximal groove 1244. The proximal engagement surface 1242 of the
first central support member 1241 contacts and is configured to
slide along the second engagement surface 1263 of the first
proximal intermediate member 1260 when the proximal groove 1244
slides along the protrusion 1266 of the first proximal intermediate
member 1260.
[0260] Likewise, the second central support member 1251 of the
central portion 1240 includes a proximal engagement surface 1252
and a distal engagement surface 1253. The second central support
member 1251 defines a notch 1256 configured to allow the drive
screw 1283 to pass through the second central support member 1251
when the implant 1200 is in the first configuration. The proximal
engagement surface 1252 defines a proximal groove 1254 and the
distal engagement surface 1253 defines a distal groove 1255. The
second central support member 1251 is configured similar to the
first central support member 1241 described above.
[0261] Implant 1200 has multiple configurations. FIG. 47 shows the
implant 1200 in a first configuration. In the first configuration,
the proximal end portion 1280, the distal end portion 1210 and the
central portion 1240 are substantially coaxial (i.e., substantially
share a common longitudinal axis). Moreover, the first central
support member 1241 is in contact with the second central support
member 1251.
[0262] The implant 1200 can be moved from the first configuration
to a second configuration as illustrated in FIG. 48. In the second
configuration the first distal intermediate member 1220, the second
distal intermediate member 1230, the first proximal intermediate
member 1260, the second proximal intermediate member 1270, the
first central support member 1241 and/or the second central support
member 1251 can be offset from the actuator 1211 and the tool
engagement member 1282.
[0263] In use, implant 1200 can be inserted percutaneously into a
disc space (not shown in FIGS. 47-60). In this manner, the implant
1200 can be used, for example, as a fusion cage. Accordingly, in
some embodiments, various portions of the implant 1200 (e.g., the
outer surfaces of the central element 1240) can include features to
enhance its biomechanical performance. Such features can include,
for example, holes and/or textured surfaces within which bone
material and/or bone growth enhancing substances can be
disposed.
[0264] The implant 1200 can be inserted when in the first
configuration, by, for example, an insertion tool as shown herein.
The distal end portion 1210 can be inserted first and is moved past
the center of the disc space until at least the central portion
1240 is positioned within the disc space. Once in the disc space,
the implant 1200 can be moved from the first configuration to the
second configuration. In the second configuration, the first and
second proximal intermediate members 1260, 1270 and the first and
second distal intermediate members 1220, 1230 can be offset from
the actuator 1211 and the tool engagement member 1282. This causes
the first central support member 1241 of the central portion 1240
and the second central support member 1251 of the central portion
1240 to move in relation to the actuator 1211 and the tool
engagement member 1282 as further described herein. In this manner,
the first central support member 1241 and the second central
support member 1251 can distract and/or maintain a minimal spacing
of the disc space. More particularly, the first central support
member 1241 and the second central support member 1251 can contact
the vertebral endplates to stabilize the spinal segment within
which the implant 1200 is disposed.
[0265] To move the implant 1200 from the first configuration to the
second configuration, the drive screw 1283 is rotated within the
actuator 1211. In some embodiments, the drive screw 1283 can be
rotated by an insertion tool such as those described in U.S. patent
application Attorney Docket No. KYPH-040/02US 305363-2272 entitled
"Tools and Methods for insertion and Removal of Medical Implants,"
which is incorporated herein by reference in its entirety. The
insertion tool (not shown) can be configured to be removably
coupled to the tool engagement member 1282 such that rotation of
the tool engagement member 1282 relative to the insertion tool
about the longitudinal axis A.sub.L is limited. In some
embodiments, the insertion tool can be configured to be removably
coupled to the tool engagement member 1282 such that axial movement
of the tool engagement member 1282 relative to the insertion tool
is limited. In some embodiments, for example, the insertion tool
can be coupled to an outer surface of the tool engagement member
1282. In such embodiments, the outer surface of the tool engagement
member 1282 can be configured to facilitate the docking of the
insertion tool (not shown) to the implant 1200. For example, in
some embodiments, the outer surface of the tool engagement member
1282 can include a lead-in chamfer, a tapered portion and/or a
beveled edge to facilitate the docking of the insertion to onto the
tool engagement member 1282 of the implant 1200. In other
embodiments, the insertion tool can be matingly coupled to a
protrusion and/or a recess of the tool engagement member 1282. The
insertion tool can include an actuator configured to be inserted
into the tool head 1284 of the drive screw 1283 to rotate the drive
screw 1283 about the longitudinal axis A.sub.L. This arrangement
allows the drive screw 1283 to be rotated without rotating the
other portions of the implant 1200.
[0266] When the drive screw 1283 is rotated as indicated by the
arrow CC in FIG. 49, the drive screw 1283 moves the actuator 1211
relative to the tool engagement member 1282, and towards the
central portion 1240. Accordingly, the first engagement surface
1216 of the actuator 1211 exerts a force on the first engagement
surface 1222 of the first distal intermediate member 1220, and the
second engagement surface 1217 of the actuator 1211 exerts a force
on the first engagement surface 1232 of the second distal
intermediate member 1230. These forces cause the first distal
intermediate member 1220 to slide on the first engagement surface
1216 of the actuator 1211 causing the first distal intermediate
member 1220 to move in the direction AA (see FIG. 50), and the
second distal intermediate member 1230 to slide on the second
engagement surface 1217 of the actuator 1211 causing the second
distal intermediate member 1230 to move in the direction BB.
[0267] Similarly, when the drive screw 1283 is rotated as indicated
by the arrow CC in FIG. 49, the first engagement surface 1286 of
the tool engagement member 1282 exerts a force on the first
engagement surface 1262 of the first proximal intermediate member
1260 and the second engagement surface 1287 of the tool engagement
member 1282 exerts a force on the first engagement surface 1272 of
the second proximal intermediate member 1270. These forces cause
the first proximal intermediate member 1260 to slide on the first
engagement surface 1286 of the tool engagement member 1282 causing
the first proximal intermediate member 1260 to move in the
direction AA, and the second proximal intermediate member 1270 to
slide on the second engagement surface 1287 of the tool engagement
member 1282 causing the second proximal intermediate member 1270 to
move in the direction BB.
[0268] As the first distal intermediate member 1220 slides on the
first engagement surface 1216 of the actuator 1211, the second
engagement surface 1223 of the first distal intermediate member
1220 exerts a force on the distal engagement surface 1243 of the
first central support member 1241 of the central portion 1240.
Likewise, as the first proximal intermediate member 1260 slides on
the first engagement surface 1286 of the tool engagement portion
1282, the second engagement surface 1263 of the first distal
intermediate member 1260 exerts a force on the proximal engagement
surface 1242 of the first central support member 1241 of the
central portion 1240. The force exerted on the distal engagement
surface 1243 of the first central support member 1241 and the force
exerted on the proximal engagement surface 1242 of the first
central support member 1241 cause the first central support member
1241 to move in the direction AA.
[0269] Furthermore, as the second distal intermediate member 1230
slides on the second engagement surface 1217 of the actuator 1211,
the second engagement surface 1233 of the second distal
intermediate member 1230 exerts a force on the distal engagement
surface 1253 of the second central support member 1251 of the
central portion 1240. Likewise, as the second proximal intermediate
member 1270 slides on the second engagement surface 1287 of the
tool engagement portion 1282, the second engagement surface 1273 of
the second distal intermediate member 1270 exerts a force on the
proximal engagement surface 1252 of the second central support
member 1251 of the central portion 1240. The force exerted on the
distal engagement surface 1253 of the second central support member
1251 and the force exerted on the proximal engagement surface 1252
of the second central support member 1251 causes the second central
support member 1251 to move in the direction AA.
[0270] To remove and/or reposition the implant 1200, the drive
screw 1283 is rotated as indicated by the arrow DD in FIG. 49, by
for example, a removal tool (may be similar to an insertion tool).
Rotating the drive screw 1283 in direction DD, causes the dovetail
configuration of the protrusions 1218, 1219 of the actuator 1211
and the dovetail configurations of the protrusions 1288, 1289 of
the tool engagement member 1282 to pull the distal intermediate
members 1220, 1230 and the proximal intermediate members 1260, 1270
back into the first configuration. This causes the dovetail
configurations of the protrusions 1226, 1236 of the distal
intermediate members 1220, 1230 and the dovetail configurations of
the protrusions 1266, 1276 of the proximal intermediate members
1260, 1270 to pull the support members 1241, 1251 back into the
first configuration.
[0271] Although the implant 1200 is shown is being movable between
a first configuration (FIG. 49) and a second configuration (FIG.
50), the implant 1200 can be maintained in any number of different
configurations. For example, the implant 1200 can be maintained in
any suitable configuration between the first configuration and the
second configuration. Said another way, the implant 1200 can be
placed in an infinite number of different configurations between
the first configuration and the second configuration. Thus, the
disc space can be distracted by the first central support member
1241 and the second central support member 1251 by any desired
amount within a predetermined range. In this manner, a single
implant 1200 can be used to treat a wide range of conditions and/or
locations within the body requiring different amounts of
distraction. Moreover, this arrangement allows the amount of
distraction to be varied in situ over time.
[0272] For example, in some embodiments, the amount of distraction
can be varied within a range of approximately 8 mm to 16 mm. Within
this range, the size of the central portion 1240 can be adjusted to
any desired amount by rotating the drive screw 1283 a predetermined
amount, as described above. In other embodiments, the range of
distraction can be approximately 4 mm (e.g., a range from 5 mm to 9
mm, a range from 12 mm to 16 mm, or the like). In yet other
embodiments, the range of distraction can be approximately 3 mm
(e.g., a range from 10 mm to 13 mm, a range from 12 mm to 15 mm, or
the like).
[0273] FIGS. 61-63 show an implant 2200 according to an embodiment.
The implant 2200 is structured like and functions similar to the
implant 1220 without intermediate members 2220, 2230, 2260 and
2270, but with a single central support member. FIG. 61 shows
various views of the implant 2200 in a first configuration and a
second configuration. FIGS. 62 and 63 show exploded views of the
implant 2200. In use, implant 2200 is inserted percutaneously into
a disc space (not shown in FIGS. 61-63), in the first
configuration, by, for example, an insertion tool as described in
U.S. patent application Attorney Docket No. KYPH-040/02US
305363-2272 entitled "Tools and Methods for insertion and Removal
of Medical Implants," which is incorporated herein by reference in
its entirety. The implant 2200 can then be moved into the second
configuration to maintain a minimal spacing of the disc space. The
implant 2200 may also be used as a distraction tool; in such a use,
the implant 2200 can be moved into the second configuration to move
the spinous processes.
[0274] The various implants, deployment/insertion tools, and guide
members described herein can be constructed with various
biocompatible materials such as, for example, titanium, titanium
alloyed, surgical steel, biocompatible metal alloys, stainless
steel, plastic, polyetheretherketone (PEEK), carbon fiber,
ultra-high molecular weight (UHMW) polyethylene, biocompatible
polymeric materials, etc. The material of a central portion of the
implant can have, for example, a compressive strength similar to or
higher than that of bone. In one embodiment, the central portion of
the implant, which is placed between the two adjacent spinous
processes, is configured with a material having an elastic modulus
higher than the elastic modulus of the bone, which forms the
spinous processes. In another embodiment, the central portion of
the implant is configured with a material having a higher elastic
modulus than the materials used to configure the distal and
proximal portions of the implant. For example, the central portion
of the implant may have an elastic modulus higher than bone, while
the proximal and distal portions have a lower elastic modulus than
bone. In yet another embodiment, the implant is configured with an
outer shell and an inner core. The outer shell can be configured
with material having a higher elastic modulus than the inner core
(e.g., outer shell is made with titanium alloyed, while the inner
core is made with a polymeric material). Alternatively, the outer
shell can be configured with a material having a lower elastic
modulus than the inner core (e.g., the outer shell is made with a
polymeric material while the inner core is made with a titanium
alloyed material).
[0275] While various embodiments have been described above, it
should be understood that they have been presented by way of
example only, and not limitation. Where methods described above
indicate certain events occurring in certain order, the ordering of
certain events may be modified. Additionally, certain of the events
may be performed concurrently in a parallel process when possible,
as well as performed sequentially as described above.
[0276] Although the interspinous process implant 1100 and the disc
implant 1200 are shown and described as including protrusions and
grooves configured to matingly couple various components thereof,
in other embodiments, an interspinous process implant and/or a disc
implant need not include components that are matingly coupled. For
example, in some embodiments, a disc implant can include an
actuator configured to actuate a spacer that is devoid of mating
protrusions and/or grooves. Similarly, in some embodiments, an
interspinous process implant can include an actuator configured to
actuate a retention member that is devoid of mating protrusions
and/or grooves. For example, in such embodiments, a retention
member can be magnetically coupled to the actuator.
[0277] Although the engagement surfaces are shown and described
above as being planar, in some embodiments, an implant can include
an engagement surface that is curved.
[0278] In some embodiments, the implants shown and described can be
biased in the first configuration or the second configuration. For
example in some embodiments, an implant can include a spring and/or
the like to bias a portion of the implant as desired. Additionally,
in some embodiments an implant can include a locking member to
temporally maintain the implant in a particular configuration.
Similarly stated, in some embodiments an implant can include a
locking member configured to temporally maintain the implant in the
first configuration if the implant is biased to be in the second
configuration, and vise versa. For example, a locking member can be
disposed within a retention member such that an end portion of the
locking member is received within a recess of a central body to
temporarily maintain the implant in a first and/or a second
configuration. In other embodiments, an implant can include a first
locking member or detent to temporarily maintain the implant in a
first configuration and/or a second locking member or detent to
temporarily maintain the implant in a second configuration.
[0279] As discussed herein, the implants shown and described above
can be inserted into the body percutaneously and/or in a
minimally-invasive manner. For example, in some embodiments, an
implant of the types shown and described above can be inserted
through a skin incision of less than 20 mm in length. In other
embodiments, an implant of the types shown and described above can
be inserted through a skin incision of less than 15 mm in length.
In yet other embodiments, an implant of the types shown and
described above can be inserted through a skin incision of less
than 10 mm in length.
[0280] Although many of the implants shown and described above
include components (e.g., an actuator) having a dovetail protrusion
configured to be matingly and movably coupled to other components
(e.g., a retention member or spacer) having a dovetail groove, it
should be understood that either component can include the
protrusion and/or the groove. Moreover, although the protrusions
and/or grooves are described above as being dovetail protrusions
and/or grooves, in other embodiments, an implant can include
components that are matingly and movably coupled together by any
suitable type of protrusion and groove. For example, FIGS. 64-66
show examples of protrusions and grooves that can be used to
matingly and movably couple components of any of the implants
described herein. FIG. 64 shows a first implant component 10
matingly and movably coupled to a second implant component 20. The
first implant component 10 has a protrusion 12 having an undercut
14. The second implant 20 defines a groove 22 having an undercut
24. The protrusion 12 is disposed within the groove 22 such that
the first implant component 10 can move relative to the second
implant component 20 (e.g., in a direction normal to the plane
shown in FIG. 64), while remaining coupled together.
[0281] FIG. 65 shows a first implant component 10' matingly and
movably coupled to a second implant component 20'. The first
implant component 10' has a curved protrusion 12' having an
undercut 14'. The second implant 20' defines a groove 22' having a
curved shape and having an undercut 24'. The protrusion 12' is
disposed within the groove 22' such that the first implant
component 10' can move relative to the second implant component 20'
(e.g., in a direction normal to the plane shown in FIG. 65), while
remaining coupled together.
[0282] FIG. 66 shows a first implant component 10'' matingly and
movably coupled to a second implant component 20''. The first
implant component 10'' has a circular protrusion 12'' having an
undercut 14''. The protrusion 12'' can also be a substantially
spherical protrusion. The second implant 20'' defines a groove 22''
having a circular (or substantially spherical) shape and having an
undercut 24''. The protrusion 12'' is disposed within the groove
22'' such that the first implant component 10'' can move relative
to the second implant component 20'' (e.g., in a direction normal
to the plane shown in FIG. 66), while remaining coupled
together.
[0283] Although various embodiments have been described as having
particular features and/or combinations of components, other
embodiments are possible having a combination of any features
and/or components from any of embodiments where appropriate. For
example, in some embodiments, a disc implant similar to the implant
1200 can include a tool engagement portion similar to the tool
engagement portion of the implant 3100.
* * * * *