U.S. patent application number 12/556820 was filed with the patent office on 2010-01-21 for expandable attachment device and method.
This patent application is currently assigned to Stout Medical Group, L.P.. Invention is credited to E. Skott GREENHALGH, Michael Paul IGOE, Robert A. KIEFER, John-Paul ROMANO, Wade Kevin TREXLER.
Application Number | 20100016905 12/556820 |
Document ID | / |
Family ID | 39759872 |
Filed Date | 2010-01-21 |
United States Patent
Application |
20100016905 |
Kind Code |
A1 |
GREENHALGH; E. Skott ; et
al. |
January 21, 2010 |
EXPANDABLE ATTACHMENT DEVICE AND METHOD
Abstract
An attachment device with a radially expandable section is
disclosed. The attachment device can have helical threads, for
example, to facilitate screwing the attachment device into a bone.
Methods of using the same are also disclosed. The attachment device
can be positioned to radially expand the expandable section in
cancellous bone substantially surrounded by cortical bone.
Inventors: |
GREENHALGH; E. Skott; (Lower
Gwynedd, PA) ; ROMANO; John-Paul; (Chalfont, PA)
; IGOE; Michael Paul; (Seabrook, TX) ; KIEFER;
Robert A.; (Quakertown, PA) ; TREXLER; Wade
Kevin; (Coopersburg, PA) |
Correspondence
Address: |
LEVINE BAGADE HAN LLP
2400 GENG ROAD, SUITE 120
PALO ALTO
CA
94303
US
|
Assignee: |
Stout Medical Group, L.P.
Perkasie
PA
|
Family ID: |
39759872 |
Appl. No.: |
12/556820 |
Filed: |
September 10, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
PCT/US2008/003421 |
Mar 12, 2007 |
|
|
|
12556820 |
|
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|
60906791 |
Mar 12, 2007 |
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Current U.S.
Class: |
606/313 |
Current CPC
Class: |
A61B 2017/00004
20130101; A61B 17/8685 20130101; A61B 17/8875 20130101; A61C 8/0033
20130101; A61B 17/744 20130101; A61B 17/861 20130101; A61B 17/7291
20130101; A61B 17/863 20130101; A61B 17/8872 20130101; A61B 17/866
20130101; A61B 17/7258 20130101; A61B 17/8858 20130101; A61B
17/7098 20130101 |
Class at
Publication: |
606/313 |
International
Class: |
A61B 17/86 20060101
A61B017/86 |
Claims
1. An attachment device having a longitudinal axis comprising: a
radially expandable length comprising a deformable frame, and
wherein the frame comprises a plurality of struts, and wherein the
plurality of struts defines a plurality of open cells, and a length
configured to attach to a separate device.
2. The device of claim 1, wherein the radially expandable length is
configured to radially expand when the radially expandable length
is longitudinally contracted.
3. The device of claim 1, wherein the radially expandable length is
configured to radially expand when the radially expandable length
is rotated.
4. The device of claim 1, wherein the radially expandable length is
configured to radially expand when a wedge is translated into the
radially expandable length.
5. The device of claim 1, wherein the attachment device further
comprises a radially unexpandable length.
6. The device of claim 1, wherein the radially expandable length
comprises a cam.
7. The device of claim 1, wherein the radially expandable length
comprises a ramp configuration.
8. The device of claim 1, further comprises a threaded length.
9. The device of claim 8, wherein the threaded length is on the
opposite side of the radially expandable length from the length
configured to attach to a separate device.
10. The device of claim 9, wherein the threaded length is radially
unexpandable.
11. The device of claim 1, wherein the length configured to attach
to a separate device has a substantially spherical
configuration.
12. The device of claim 1, wherein the length configured to attach
to a separate device has an interface configured to attach to a
removable deployment tool.
13. A method for deploying an attachment device having a
longitudinal axis in a bone comprising: inserting the attachment
device of claim 1 into the bone, radially expanding a radially
expandable length of the attachment device.
14. The method of claim 13, wherein radially expanding comprises
radially expanding a radially expandable length of the attachment
device in a cancellous portion of the bone.
15. The method of claim 13, wherein inserting comprises inserting
into a vertebral body.
16. The method of claim 13, wherein radially expanding comprises
longitudinal compressing the attachment device.
17. The method of claim 13, wherein radially expanding comprises
rotating the attachment device.
18. The method of claim 13, wherein radially expanding comprises
inserting a leverage element into the attachment device.
19. The method of claim 18, wherein the leverage element comprises
a wedge.
20. The method of claim 13, wherein the attachment device comprises
a resilient section, and wherein radially expanding comprises
releasing a mechanical constraint from the resilient section.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The application is a continuation of PCT Application No.
PCT/US2008/003421, filed Mar. 12, 2008, which claims priority to
U.S. Provisional Application No. 60/906,791, filed Mar. 12, 2007,
both of which are incorporated by reference herein in their
entireties.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates generally to a device and
method for attaching to bones.
[0004] 2. Description of Related Art
[0005] Broken bones, such as compression fractures of one or more
vertebrae in the spine, may be treated with internal fixation. Any
indication needed spinal stability can also be treated by internal
fixation. Examples include scoliosis, kyphosis, spondylothisthesis
and rotation, segmental instability, such as disc degeneration and
fracture caused by disease and trauma and congenital defects, and
degeneration caused by tumors.
[0006] As shown by FIG. 1, internal fixation in the spine is often
accomplished by first screwing fixation screws into the pedicles
and vertebral bodies of the vertebrae 10. FIG. 2 shows that the
fixation screws are then typically attached to a rigid fixation rod
or plate that provide support between one or more weakened vertebra
10. This support often immobilizes the vertebra 10 to which the
fixation screws have been inserted.
[0007] FIG. 3 illustrates that existing fixation systems often have
the fixation rod 14 or plate 220, through which a number of
fixation screws 12 are deployed. The screw head 18 prevents the
fixation rod 14 from separating from the fixation screw 12. The
fixation screw 12 also has a screw body 16 which has a screw
longitudinal axis 20 often static relative to the fixation rod
14.
[0008] FIG. 4 illustrates that in some existing fixation systems,
the fixation screws 12 can be polyaxial screws: attached to the
fixation rod 14 or plate 220 in a manner so that the screw
longitudinal axis 20 can rotate, as shown by arrows, with respect
to the fixation rod 14.
[0009] Backing out or loosening of the fixation screws 12 can cause
a reduction of the fixation, up to complete failure or even
resulting in additional complications.
[0010] Furthermore, the bones are often weak and under heavy loads,
the bones can fail and the fixation screws 12 can be ripped from
the bone resulting in complete failure and additional damage to the
bone.
[0011] Therefore, a fixation screw that can substantially eliminate
the risk of backout, and can provide a higher anchoring force is
desired. A fixation screw that can also minimize bone failure is
desired.
SUMMARY OF THE INVENTION
[0012] An expandable attachment device and methods for using the
same are disclosed. The expandable attachment device can have a
radially expandable section and a distal end. The distal end can be
configured to be attached to a separate device, such as a fixation
rod or plate. The device can have an unexpandable section.
[0013] Also disclosed is an expandable attachment device that can
have a radially expandable section and an unexpandable section. The
unexpandable section and/or the radially expandable section can
have external threads.
[0014] The devices described herein can be used as substitutes for
fixation screws in existing fixation systems. The devices can be
used to treat broken bones, scoliosis, kyphosis, spondylothisthesis
and rotation, segmental instability, such as disc degeneration and
fracture caused by disease and trauma and congenital defects, and
degeneration caused by tumors.
[0015] The devices can be configured to be used in systems with
fixed screw longitudinal axis or polyaxial configurations.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] FIG. 1 is a partially see-through top view of a vertebra
with fixation screws therethrough.
[0017] FIG. 2 is a partially see-through lateral view of a section
of the spine with fixation screws and a fixation rod.
[0018] FIGS. 3 and 4 illustrate simplified variations of existing
fixation systems.
[0019] FIG. 5 illustrates a variation of the expandable attachment
device in a radially contracted configuration.
[0020] FIG. 6 illustrates the variation of the expandable
attachment device in a radially expanded configuration.
[0021] FIG. 7 illustrates a variation of the expandable attachment
device in a radially contracted configuration.
[0022] FIGS. 8 and 9 illustrate a variation of the expandable
attachment device and a method for radially expanding the
device.
[0023] FIGS. 10 and 11 illustrate a variation of the expandable
attachment device and a method for radially expanding the
device.
[0024] FIGS. 12 and 13 illustrate a variation of the expandable
attachment device and a method for radially expanding the
device.
[0025] FIGS. 14 and 15 illustrate a variation of the expandable
attachment device and a method for radially expanding the
device.
[0026] FIGS. 16 and 17 illustrate a variation of the expandable
attachment device and a method for radially expanding the
device.
[0027] FIG. 18 illustrates a variation of the expandable attachment
device in a contracted configuration.
[0028] FIGS. 19 and 20 illustrate variations of the expandable
attachment device of FIG. 18 and methods for radially expanding the
device.
[0029] FIG. 21 illustrates a variation of the expandable section in
a radially contracted configuration.
[0030] FIG. 22 illustrates the expandable section of FIG. 21 in a
radially expanded configuration.
[0031] FIG. 23 illustrates a variation of the expandable section in
a radially contracted configuration on the expandable attachment
device.
[0032] FIG. 24 illustrates a variation of the expandable section in
a radially expanded configuration on the expandable attachment
device.
[0033] FIG. 25a through FIG. 25e illustrate variations of the
expandable section.
[0034] FIGS. 26 and 27 illustrate a variation of the expandable
attachment device and a method for radially expanding the
device.
[0035] FIGS. 28 and 29 illustrate a variation of the expandable
attachment device and a method for radially expanding the
device.
[0036] FIGS. 30 and 31 illustrate variations of the expandable
attachment device.
[0037] FIGS. 32 and 33 are side and end perspective views,
respectively, of a variation of the expandable attachment
device.
[0038] FIG. 34 is a side view of a variation of the expandable
attachment device.
[0039] FIGS. 35a and 35b illustrate a variation of the expandable
section.
[0040] FIG. 36 is a side view of the expandable section of FIGS.
35a and 35b.
[0041] FIG. 37 is a variation of a close-up view of section A-A of
FIG. 36.
[0042] FIG. 38 is a flattened view of a variation of the expandable
section.
[0043] FIG. 39 is a variation of a close-up view of section B-B of
FIG. 38.
[0044] FIGS. 40a and 40b are flattened views of variations of the
expandable section.
[0045] FIG. 41 illustrates a variation of the unexpandable section
integral with the central shaft and distal end of the expandable
attachment device.
[0046] FIG. 42 illustrates a variation of cross-section C-C of FIG.
41.
[0047] FIG. 43 illustrates a variation of cross-section D-D of FIG.
41.
[0048] FIG. 44 is a variation of a close-up E-E of FIG. 42.
[0049] FIG. 45 is a distal end view of a variation of the
unexpandable section integral with the central shaft and distal end
of the expandable attachment device of FIG. 41.
[0050] FIG. 46 illustrates a variation of the center shaft integral
with the unexpandable section and the distal end.
[0051] FIGS. 47a and 47b are various perspective views of a
variation of the distal end cap.
[0052] FIG. 48 is a side view of a variation of the distal end
cap.
[0053] FIG. 49 is a distal end view of a variation of the distal
end cap.
[0054] FIG. 50 illustrates a variation of cross-section Z-Z of FIG.
47a.
[0055] FIG. 51 illustrates a variation of cross-section Y-Y of FIG.
47b.
[0056] FIG. 52 illustrates a variation of the expandable attachment
device attached to a variation of the deployment tool.
[0057] FIGS. 53 and 54 illustrate a variation of the expandable
attachment device in unassembled and assemble configurations,
respectively, and a method for assembling the expandable attachment
device.
[0058] FIG. 55 illustrates a variation of the deployment tool in an
unassembled configuration.
[0059] FIG. 56 is a close-up perspective view of the end of the
deployment tool in an assembled configuration.
[0060] FIG. 57 illustrate variations of the expandable attachment
device in radially expanded configurations, and measurements
thereof.
[0061] FIGS. 58 and 59 illustrate a variation of the expandable
attachment device and a method for radially expanding the
device.
[0062] FIGS. 60 and 61 illustrate a variation of the expandable
attachment device and a method for radially expanding the
device.
[0063] FIG. 62 illustrates a variation of the expandable attachment
device and a method for radially expanding the device.
[0064] FIGS. 63 and 64 illustrate a variation of the expandable
attachment device and a method for radially expanding the
device.
[0065] FIG. 65 illustrates a variation of cross-section F-F of FIG.
64.
[0066] FIG. 66 is a perspective view of a variation of the
expandable section in a radially contracted configuration.
[0067] FIG. 67 is an end view of the variation of the expandable
section of FIG. 66 in a radially contracted configuration.
[0068] FIG. 68 is an end view of the variation of the expandable
section of FIG. 66 in a radially expanded configuration.
[0069] FIGS. 69 and 70 are perspective views of variations of the
expandable section.
[0070] FIG. 71 illustrates a variation of the expandable section
with the deployment rod.
[0071] FIGS. 72 and 73 illustrate variations of cross-section W-W
of FIG. 71.
[0072] FIGS. 74 and 75 illustrate variations of cross-section W-W
of FIG. 72.
[0073] FIGS. 76 and 77 illustrate a variation of the expandable
section of FIG. 70 with a wedge, and a method for using the
same.
[0074] FIG. 78 illustrates a variation of cross-section V-V of FIG.
77.
[0075] FIGS. 79a, 79b, 79c, and 79d illustrate perspective, top,
side, and rear views of a variation of the manipulation tool.
[0076] FIGS. 80 through 82 illustrate a variation of the expandable
section and a method for radially expanding the same.
[0077] FIGS. 83 and 84 illustrate variations of the expandable
section.
[0078] FIGS. 85 and 86 illustrate various perspective views of a
variation of the expandable attachment device in a radially
contracted configuration.
[0079] FIG. 87 illustrates a variation of cross-section G-G of FIG.
86.
[0080] FIGS. 88 and 89 illustrate various perspective views of the
variation of the expandable attachment device of FIGS. 85 through
87 in a radially expanded configuration.
[0081] FIGS. 90 and 91 illustrate a variation of the expandable
attachment device and a method for radially expanding the
device.
[0082] FIGS. 92 and 93 illustrate a variation of the expandable
attachment device and a method for radially expanding the
device.
[0083] FIG. 94 illustrates a variation of the expandable attachment
device and a method for radially expanding the device.
[0084] FIGS. 95 and 96 illustrate proximal end views of variations
of the expandable attachment device.
[0085] FIGS. 97 and 98 illustrate a variation of a the expandable
section in radially contracted and expanded configurations,
respectively.
[0086] FIGS. 99 and 100 are side and proximal end views,
respectively, of a variation of the expandable section with the
center shaft.
[0087] FIGS. 101 and 102 are side and proximal end views,
respectively, of a variation of the expandable section.
[0088] FIGS. 103 and 104 are front and side perspective views,
respectively, of a variation of the expandable element.
[0089] FIGS. 105 through 107 illustrate variations of the
expandable element.
[0090] FIGS. 108 and 109 illustrate a variation of the expandable
section and distal end and a method for radially expanding the
device.
[0091] FIGS. 110 and 111 illustrate variations of the expandable
section.
[0092] FIGS. 112 and 113 illustrate a variation of the expandable
attachment device and a method for radially expanding the
device.
[0093] FIG. 114 illustrates a variation of the expandable element
of FIGS. 112 and 113.
[0094] FIG. 115 illustrates a variation of cross-section K-K of
FIG. 114.
[0095] FIGS. 116 and 117 illustrate cross-sections H-H and J-J,
respectively, of FIGS. 112 and 113, respectively.
[0096] FIGS. 118 and 119 illustrate a variation of the expandable
attachment device and a method for radially expanding the
device.
[0097] FIG. 120a illustrates a variation of multiple expandable
elements.
[0098] FIG. 120b is an end view of a variation of the expandable
section in a contracted configuration.
[0099] FIG. 120c is an end view of a variation of the expandable
section in a radially expanded configuration and a method for
radially expanding the expandable section.
[0100] FIGS. 121, 122, 123 and 124 are side, perspective, distal
end, and proximal end views, respectively, of a variation of the
expandable attachment device in a radially contracted
configuration.
[0101] FIGS. 125, 126, and 127 are distal end, proximal end, and
side views, respectively, of a variation of the expandable
attachment device of FIGS. 121 through 124 in a radially expanded
configuration.
[0102] FIGS. 128 and 129 are front and perspective views,
respectively, of a variation of the expandable section in a
radially contracted configuration.
[0103] FIGS. 130 and 131 are front and perspective views,
respectively, of the variation of the expandable section of FIGS.
128 and 129 in a radially expanded configuration.
[0104] FIGS. 132 and 133 are front and perspective views,
respectively, of the variation of the expandable section of FIGS.
128 and 129 in a radially expanded configuration.
[0105] FIGS. 134 and 135 are perspective and side views,
respectively, of a variation of the center shaft.
[0106] FIG. 136 is an end view of a variation of the expandable
section in a radially contracted configuration.
[0107] FIG. 137 is an end view of the expandable section of FIG.
136 in a radially expanded configuration.
[0108] FIG. 138 is a perspective view of the first expandable
element and the second expandable element of FIG. 137.
[0109] FIG. 139 is a perspective view of the expandable section of
FIG. 137.
[0110] FIGS. 140 through 142 illustrate variations of the
expandable section in radially contracted configurations.
[0111] FIG. 143 illustrates a variation of the expandable
attachment device with the expandable section of FIG. 141.
[0112] FIG. 144 illustrates an unassembled expandable attachment
device of FIG. 143.
[0113] FIG. 145 illustrates a variation of cross-section L-L of
FIG. 143 during use.
[0114] FIG. 146 illustrates a variation of the expandable
attachment device.
[0115] FIGS. 147, 148 and 149 illustrate variations of the
expandable attachment device with the expandable section of FIGS.
140, 141 and 142, respectively.
[0116] FIGS. 150 and 151 illustrate side and perspective views,
respectively, of a variation of the expandable section in a
radially contracted configuration.
[0117] FIGS. 152 and 153 illustrate variations of the expandable
section in radially expanded configurations.
[0118] FIG. 154 is a lateral view of the spine.
[0119] FIG. 155 illustrates cross-section M-M of FIG. 154.
[0120] FIG. 156 illustrates cross-section M-M of FIG. 154 with an
expandable attachment device delivered into the pedicle and/or
vertebral body.
[0121] FIG. 157 is a partial see-through lateral view of the spine
with a variation of the expandable attachment device delivered to,
and radially expanded in, the pedicle and/or vertebral body.
[0122] FIG. 158 illustrates cross-section M-M of FIG. 157.
[0123] FIG. 159 illustrates a variation of a method for using a
variation of the expandable attachment device to treat a broken
bone.
[0124] FIG. 160 illustrates a variation of a method for using two
variations of the expandable attachment devices to treat a broken
bone.
[0125] FIGS. 161 and 162 illustrate a variation of a method for
attaching an end attachment to the remainder of a variation of the
expandable attachment device.
[0126] FIG. 163 illustrates a variation of method for using a
variation of the expandable attachment devices with a fixation rod
in the spine.
[0127] FIG. 164 illustrates a variation of a method for using a
variation of the expandable attachment devices with end attachments
in the spine.
[0128] FIGS. 165 through 167 illustrate a variation of a method for
expanding first and second expandable sections on a variation of
the expandable attachment device.
[0129] FIGS. 168 and 169 illustrate variations of methods for using
a variation of the expandable support device in the spine.
[0130] FIG. 170 is an anterior view of a variation of a method for
using the expandable attachment device in a spine with a fixation
plate.
[0131] FIGS. 171 and 172 are sagittal cross-sections of a variation
of a method for using the expandable attachment device in a spine
with a fixation plate.
[0132] FIG. 173 illustrates a variation of the deployment tool.
[0133] FIGS. 174 through 178 illustrate a variation of a method for
implanting a variation of the expandable attachment device for use
as a tooth anchor.
[0134] FIGS. 179 and 180 illustrate a variation of a method for
implanting a variation of the expandable attachment device for use
as a tooth anchor.
[0135] FIG. 181 illustrates a variation of the expandable
attachment device.
[0136] FIG. 182 is a close-up view of the expandable attachment
device of FIG. 181.
[0137] FIG. 183 illustrates cross-section S-S of the expandable
attachment device of FIG. 181.
[0138] FIG. 184 illustrates a variation of close-up section T-T of
the expandable attachment device of FIG. 183
[0139] FIG. 185 is a close-up view of a variation of the expandable
attachment device.
[0140] FIG. 186 is an expanded view of the expandable attachment
device of FIG. 185.
[0141] FIG. 187 illustrates a variation of cross-section U-U of
FIG. 186.
DETAILED DESCRIPTION OF THE INVENTION
[0142] FIG. 5 illustrates that the expandable attachment device 22
can have an unexpandable section 28 at a proximal end, an
expandable section 24 at a medial length along the expandable
attachment device 22, and a distal end 34. In other variations of
the expandable attachment device, the unexpandable section 28 can
be distal to the expandable section 24, and/or the expandable
attachment device 22 can have more than one expandable section 24
and/or unexpandable section 28 that can be interspersed with each
other.
[0143] The expandable attachment device 22 can have an expandable
attachment device axis 26. The expandable device axis 26 can be
substantially straight or curved.
[0144] The proximal end of the expandable attachment device can
have a tip 32. The tip 32 can be sharpened or otherwise configured
to seat the expandable attachment device in bone (e.g., having
cutting teeth). The unexpandable section 28 can have unexpandable
thread 30, for example, configured to screw the expandable
attachment device 22 into bone.
[0145] FIG. 5 shows that the expandable attachment device 22 can
have a radially contracted configuration. FIG. 6 illustrates that
the expandable attachment device 22 can have a radially expanded
configuration. For example, the expandable section can be radially
expanded, as shown by arrows.
[0146] The expandable section 24 can be resiliently and/or
deformably expandable. The expandable sections 24 can be radially
expanded by axial compression (e.g., see FIGS. 8-11), rotation
(e.g., see FIGS. 26-29), use of a lever such as a wedge, ramp or
jack (e.g., see FIGS. 58-64), or combinations thereof.
[0147] The expandable section 24 can be biased to resiliently
radially expand. For example, the expandable section 24 can be
self-expandable or releasable spring. The expandable section 24 can
be resiliently radially expandable and can be additionally
deformably radially expandable to a larger radius than achieved by
resilient expansion alone.
[0148] The expandable section 24 can have one or more anchors
extending radially therefrom when the expandable section is in the
radially expanded configuration. The anchors can be brads, hooks,
pins, teeth, fasteners, pegs, screws, skewers, spikes, stakes, or
combinations thereof.
[0149] FIG. 7 illustrates that the expandable attachment device
axis 26 can be curved. The expandable attachment device axis 26 can
have curved and straight lengths. For example, the expandable
attachment device axis 26 can have a substantially straight length
along the unexpandable section 28 and the distal end 34, and a
curved length along the expandable section 24.
[0150] FIGS. 8 and 9 illustrates that the expandable attachment
device 22 can be radially expanded by applying a
proximally-directed force to the distal end 34 as shown by arrows
of FIG. 8. The proximally-directed force can be substantially
parallel to the expandable attachment device axis 26. The proximal
force can be opposed by a distal force applied, for example, by the
bone and/or a deployment tool. The expandable section can then
radially expand, as shown by arrows in FIG. 9.
[0151] FIGS. 10 and 11 illustrate that the expandable attachment
device 22 can have expandable thread 66 on the expandable section
and unexpandable thread 30 on the unexpandable section. The
expandable thread can radially expand with the remainder of the
expandable section. The expandable attachment device shown in FIGS.
10 and 11 can be radially expanded by the method as shown in FIGS.
8 and 9.
[0152] FIGS. 12 and 13 illustrate that the expandable attachment
device can be radially expanded by applying a distally-directed
force to the distal end as shown by arrow. The distally-directed
force can be substantially parallel to the expandable attachment
device axis. The distal force can be opposed by a proximal force
applied, for example, by the bone and/or a deployment tool. The
expandable section can then radially expand, as shown by arrows in
FIG. 13.
[0153] FIGS. 14 and 15 illustrate that the expandable attachment
device can have expandable thread on the expandable section and
unexpandable thread on the unexpandable section. The expandable
thread can radially expand with the remainder of the expandable
section. The expandable attachment device shown in FIGS. 14 and 15
can be radially expanded by the method as shown in FIGS. 12 and
13.
[0154] FIG. 16 illustrate that substantially the entire length of
the expandable attachment device can be the expandable section. The
distal end can extend distally from the expandable section. FIG. 17
illustrates that the entire expandable section can radially expand.
FIGS. 16 and 17 illustrate that the expandable section can have
expandable thread. FIGS. 18 and 19 illustrate the variation of the
expandable attachment device of FIGS. 16 and 17, respectively,
without expandable thread.
[0155] FIG. 20 illustrates that the expandable attachment device
can have, from distal to proximal, a first expandable section, a
third expandable section, and a second expandable section. The
first, second and third expandable sections can radially expand at
different rates (e.g., under different deployment loads, for
example one or more are resiliently and one or more are deformably
expandable). For example, the first and second expandable sections
can radially expand at the same rate, and the third expandable
section can radially expand at a lesser rate.
[0156] FIG. 21 illustrates that the expandable section 24 can have
a number of struts 38 attached to each other at joints 40. When the
expandable section 24 is in a radially contracted configuration,
the struts 38 can be configured to form diamond-shaped ports 42.
The expandable section 24 can have a distal hoop 36b at the distal
end and/or a proximal hoop 36a at the proximal end. The hoops 36
can attach to all of the struts 38 at the respective end. The hoops
36 and struts 38 can all be integral with and/or attached to each
other.
[0157] FIG. 22 illustrates that longitudinal compressive force 44
can be applied to the expandable section, for example resulting in
radial expansion 46. In a radially expanded configuration, the
struts can deform near the joints. The hoops can remain
substantially static.
[0158] FIGS. 23 and 24 illustrates that the expandable section can
be radially expanded by longitudinally compressing the expandable
section. For example, the deployment tool 60 (or expandable
attachment device 22) can have an anvil 142 and a deployment cap
47. The anvil 142 can be the distal end and/or the unexpandable
section. The deployment cap 47 can be part of or attached to the
unexpandable section and/or the distal end, for example, the
opposite of the anvil 142. The expandable section can be compressed
between the anvil 142 and the deployment cap 47.
[0159] The deployment tool 60 (or expandable attachment device 22)
can have a deployment rod 128, for example to transmit the
compressive force to the deployment cap 47. The deployment rod 128
can be releasably attached to the deployment cap 47, for example
via a releasable deployment anchor 49. The releasable deployment
achor can be released and the deployment rod can be removed after
the expandable section is radially expanded.
[0160] FIGS. 25a-e illustrate variations of the expandable
section's strut, port and joint configuration. FIG. 25a illustrates
that the ports can be larger near a central region 54 near the
longitudinal median of the expandable section than in end regions
52. The lengths of the expandable section with larger ports can
radially expand during longitudinal compression before the lengths
of the expandable section with smaller ports. The expandable
section can have thread 50 and/or another releasable attachment
configuration at one or both ends. The expandable section can have
a tool port 48 configured to receive a deployment tool (e.g., a
deployment rod) through the proximal end of the expandable
section.
[0161] FIG. 25b illustrates that the struts and ports can be
substantially identical along the entire length of the expandable
section. FIG. 25c can have main struts 56 and smaller folded
cross-struts 58 that attach to multiple main struts 56. FIG. 25d
illustrates that the struts and ports can be substantially
identical along the entire length of the expandable section and
that the ports can be longer in the longitudinal direction that in
the angular direction, with respect to the expandable section. FIG.
25e that the struts and ports can be substantially identical along
the entire length of the expandable section and that the ports can
be longer in the longitudinal direction that in the angular
direction, with respect to the expandable section, and smaller and
more numerous than as shown in FIG. 25d.
[0162] FIGS. 26 and 27 illustrate that when the distal end and/or
expandable section is rotated, as shown by arrow in FIG. 26, that
the expandable section can radially expand, as shown by arrows in
FIG. 27. FIGS. 26 and 27 illustrate that the expandable section can
be distal to the unexpandable section.
[0163] FIGS. 28 and 29 illustrate that when the distal end and/or
expandable section is rotated, as shown by arrow in FIG. 28, that
the expandable section can radially expand, as shown by arrows in
FIG. 29. FIGS. 28 and 29 illustrate that the unexpandable section
can be distal to the expandable section.
[0164] FIG. 30 illustrates that the expandable section can have a
slot 62 radially through the expandable section. The slot 62 can
have a helical configuration along the expandable section. The
distal end can be threaded. The expandable attachment device can be
detachably attached to a deployment tool 60.
[0165] FIG. 31 illustrates that the expandable section can have a
textured surface. The expandable attachment device can have a
distal end cap 64 at the distal end. The distal end cap can have a
substantially spherical configuration.
[0166] FIG. 32 illustrates that the expandable section can have a
helical slot 62 and an expandable thread 66. The expandable thread
66 can be helical at substantially the opposite angle of the
helical slot 62. The expandable thread can be helical at a positive
or negative angle with respect to a plane perpendicular to the
expandable attachment device axis. The helical slot can be helical
at the opposite-signed (i.e., positive or negative) angle to the
expandable thread.
[0167] FIG. 32 illustrates that the distal end of the distal end
cap can have cap deployment tool attachments 68, for example
cross-notches on the head of the cap 64. The cross-notches can be
utilized to engage the distal end cap 64 with an engagement
tool.
[0168] The distal end of the center shaft can have a shaft
deployment tool attachment 70, for example, an allen or hexagonal
or septagonal socket.
[0169] FIG. 34 illustrates that when the expandable section is in a
radially contracted configuration, the expandable thread 66 can
protrude to about the same radius at the unexpandable thread with
respect to the expandable attachment device axis.
[0170] FIGS. 35a and 35 illustrate that the expandable section can
be separate to the remainder of the expandable attachment device.
FIG. 35b illustrates that the helical slot can extend through the
thickness of the wall of the expandable section. FIGS. 36 through
39 illustrate additional details of the expandable section.
[0171] FIG. 38 illustrates that the expandable section can have an
expandable section wall 72 can have numerous helical slots in a
slotted wall section 74. The expandable section wall can have one
or more unslotted wall sections 76, for example at the distal and
proximal ends of the expandable section. The slots can have joints
at one both ends of the slots.
[0172] FIG. 39 illustrates that the joints can be circular. The
joints can have a larger, smaller or equal diameter to the width of
the slot.
[0173] FIG. 40 illustrates that the expandable section wall can
have one or more retrograde slot sections 76, for example at each
end of the slotted wall section 74. The retrograde slot section 76
can have slots 62 in the substantially opposite direction of the
slots 62 in the remainder of the slotted wall section 74. The
primary (i.e., non-retrograde) slots can be helical at a positive
or negative angle with respect to a plane perpendicular to the
expandable attachment device axis. The retrograde slots can be
helical at the opposite-signed (i.e., positive or negative) angle
to the primary slots.
[0174] The retrograde slot section 76 can, for example, act as a
shock absorber. The retrograde slot section 76 can increase maximum
radial expansion of the expandable section. The slots 62 can be
sinusoidal along the length of the expandable section.
[0175] FIG. 40b illustrates that the ends of the slots 62 can be
placed at different lengths from the ends of the expandable
section. For example, varying the lengths of adjacent slots can
diffuse strain on the expandable section.
[0176] FIGS. 41 through 45 illustrate dimensions of the expandable
section (dimensions are shown on attachment B).
[0177] FIG. 41 illustrates that the unexpandable section can be
integral with a center shaft and the distal end.
[0178] FIG. 43 illustrates that the distal end can have the shaft
deployment tool attachment therethrough.
[0179] FIG. 46 illustrates a close up of the distal end of the
unexpandable section, center shaft and distal end.
[0180] FIGS. 47a and 47b illustrate that the distal cap end can
have a cap ball and a cap sleeve. The cap ball and/or cap sleeve
can have internal cap thread along all or part of the length.
[0181] FIGS. 48 through 51 illustrate dimensions of the expandable
section (dimensions are shown on attachment C).
[0182] FIG. 52 illustrates that the expandable attachment device
can be releasably attached to the deployment tool. The deployment
tool can have deployment engagement teeth that can align and
intersect with the distal end cap, for example at the cap
deployment tool attachments.
[0183] FIG. 53 illustrates that the expandable attachment device
can be dissembled in separate elements. For example, the
unexpandable section can be integral with the center shaft. The
center shaft, for example at the distal end, can have shaft cap
attachments that can attach to the distal end cap.
[0184] FIG. 54 illustrates that the expandable attachment device
can be assembled by translating the expandable section over the
center shaft, as shown by arrow. The distal end cap can then be
rotated, as shown by arrow, onto the shaft cap attachments.
[0185] FIGS. 55 and 56 illustrate that the deployment tool can have
a post tool and a tooth tool. The tooth tool can be separate,
attached, or integral with the post tool.
[0186] The post tool can have a post tool hand. The post tool
handle can be attached to or integral with a deployment engagement
post. The post tool can have a deployment tool suspension. The
deployment engagement post can be configured to attach to the shaft
deployment tool attachment.
[0187] The tooth tool can have deployment engagement teeth. The
deployment engagement teeth can be configured to attach to the cap
deployment tool attachment. The tooth tool can have a tooth tool
handle, for example extending radially from the remainder of the
tooth tool.
[0188] The deployment tool suspension can resiliently separate the
tooth tool and the post tool. The deployment tool suspension can
suspend the deployment engagement post from the post tool
handle.
[0189] FIG. 57 illustrates the expandable section in a radially
expanded configuration can have an outer diameter 104 from about 7
mm (0.3 in.) to about 15 mm (0.59 in.), for example about 9.99 mm
(0.393 in.) or about 9.31 mm (0.367 in.).
[0190] FIGS. 58 and 59 illustrate that an external wedge can be
inserted, as shown by arrow in FIG. 58, into the expandable
section. The expandable section can then radially expand, as shown
by arrows in FIG. 59. The external wedge can be left in the
expandable section or removed from the expandable section. The
wedge can have a transverse cross section that is square, round
(e.g., a conical wedge), rectangular, oval, or combinations
thereof.
[0191] FIG. 60 illustrates that the expandable attachment device
can have a first external wedge and a second external wedge. The
second external wedge can be attached to or integral with the
unexpanded section and/or otherwise positioned between the
expandable section and the unexpanded section when the expandable
section is in a radially contracted configuration. The second
external wedge can be pointing narrow end-first toward the distal
end of the expandable attachment device.
[0192] A proximally-directed force can be applied, as shown by
arrow, to the first external wedge and/or the distal end. The
expandable section can then radially expand, as shown by arrows in
FIG. 61, as the wedges are pushed into a channel in the expandable
section.
[0193] FIG. 62 illustrates that the expandable attachment device
can have a first expandable section, second expandable section, and
third expandable section. The expandable sections can each have one
or two external wedges entering into an inner hollow or channel, as
shown in FIGS. 58 through 61.
[0194] FIG. 63 illustrates that the expandable section can have one
or more expansion elements configured to radially expand. The
expandable section can have one, two or more internal wedges. The
expansion elements can have ramps configured to slidably engage the
internal wedge when the internal wedge is compressed into the
expansion elements.
[0195] FIG. 64 illustrates that the internal wedges can be
compressed, as shown by arrows, into the expansion elements. The
expansion elements can then radially expand, as shown by
arrows.
[0196] FIG. 65 illustrates that the internal wedges can
interference fit with the ramps. As the internal wedges are further
compressed, the internal wedges can cause a deformation or other
translation of the expansion elements.
[0197] FIGS. 66 and 67 illustrates that the expandable section can
have a top wall and a bottom wall connected by two side walls. The
top wall and bottom wall can have expandable thread. The side wall
can have expandable thread. The top wall and/or bottom wall can
have one or more ramps extending inwardly into the longitudinal
channel of the expandable section.
[0198] FIG. 68 illustrates that in a radially expanded
configuration, the top wall and bottom wall can translate radially
outward, as shown by arrows. The side walls can deform and/or
translate radially inward.
[0199] FIG. 69 illustrates that the top wall and/or bottom wall can
have a manipulation channel passing completely or partially
therethrough in a substantially longitudinal direction. The
manipulation channels can be, for example, cylindrical.
[0200] FIG. 70 illustrates that the top wall and/or the bottom wall
can have longitudinal guide slots 124. The guide slots 124 can be
in fluid communication with the longitudinal channel. The guide
slots 124 can be parallel with the ramps.
[0201] FIGS. 71 and 72 illustrate that a first wedge and a second
wedge can be inserted into the longitudinal channel of the
expandable section. The second wedge and/or first wedge can be
integral with the deployment rod. The first wedge can have a
longitudinal wedge channel. The deployment rod can slidably attach
to the first wedge through the wedge channel. The first wedge and
second wedge can have configurations that substantially match the
respective ramps.
[0202] FIG. 73 illustrates that the opposing compressive first and
second translational forces can be applied to the first wedge and
the deployment rod, respectively. The first and second wedges can
be deformably translated into the expandable section.
[0203] FIG. 74 illustrates that the expandable section can radially
expand, for example near the ends of the expandable section and/or
to the length the wedges are inserted.
[0204] FIG. 75 illustrates that the expandable section and wedges
can be configured to radially expand on only one side. For example,
the wedges can have angled slopes on one side of the wedge and flat
sides on the opposing side of the angled slopes. The expandable
section can have a wall with tapered thickness on the side to be
radially expanded, and a constant thickness wall, and/or a thicker
wall than the tapered wall, on the side opposite the tapered
wall.
[0205] FIG. 76 illustrates that the wedge can have a wedge rail.
The wedge rail can align with and insert into the guide slot 124.
FIGS. 77 and 78 illustrate that the wedge rail can slidably attach
to the guide slot 124.
[0206] FIGS. 79a through 79d illustrate that a manipulation tool
can have a base, a first leg extending from the base, and a second
leg extending from the base. The legs can be configured to fit into
the manipulation channels of the expandable section. The legs can
be used to insert into the manipulation channels and manipulate
(e.g., translation, rotation, deformation) the expandable section.
Legs can articulate with respect to the base. The leg articulation
can be controlled by controls (not shown) on the base, such as a
handle or trigger.
[0207] FIG. 80 illustrates that a cone or mandrel can be translated
into the longitudinal channel of an expandable section having
struts and joints. The expandable section can have no hoops. The
expandable section can have an anvil at the opposite end of the
cone.
[0208] FIG. 81 illustrates that the cone can be forced toward the
anvil, and/or the anvil can be forced toward the cone, resulting in
longitudinal translation of the cone towards the anvil, through the
longitudinal channel. The expandable section over the cone, for
example at the distal end, can radially expand, as shown by
arrows.
[0209] FIG. 82 illustrates that the cone can be longitudinally
translated along the entire length of the expandable section. The
cone can be received in the anvil. The entire length of the
expandable section can radially expand, as shown by arrows. The
expansion can be resilient and/or deformable. The cone can be
removed or left in place.
[0210] FIG. 83 illustrates that the expandable section can have
plates that can be integral with or attached to the joints and/or
struts. The plates can be configured to be flexibly attached to or
integral with the remainder of the expandable section. Each plate
can be configured to substantially cover each port.
[0211] FIG. 84 illustrates that a first plate and a second plate
can cover a port. The first plate can extend from a first joint
adjacent to the port. The second plate can extend from a joint
opposite to the first plate.
[0212] FIGS. 85 through 87 illustrate an expandable attachment
device that can have an expandable section that can have a first
expandable element directly or indirectly slidably attached to a
second expandable element. For example, the first expandable
element can be slidably attached to the center shaft to translate
up when the center shaft is translated distally, and the second
expandable element can be slidably attached to the center shaft to
translate down when the center shaft is translated distally. When
the expandable attachment device is in a radially contracted
configuration, the center shaft can be substantially inside the
expandable element. When the expandable attachment device is in a
radially expanded configuration, the center shaft can be
substantially outside the expandable element.
[0213] The first expandable element can have the tip. The tip can
be pointed and/or flat. The first expandable element can have
thread on a top side. The first expandable element can have a peg
(shown in FIG. 87) that can extend radially inward. The peg can be
configured to slide in a first track on the side of the central
shaft. The first track can extend from being low distally to high
proximally.
[0214] The second expandable element can have thread on a bottom
side. The first expandable element can have a peg that can extend
radially inward similar to that of the first expandable element.
The peg can be configured to slide in a second track on the side of
the central shaft opposite the side of the first track. The first
track can extend from being high distally to low proximally.
[0215] FIG. 88 illustrates that when the expandable attachment
device is in a radially expanded configuration, the first
expandable element can be separated from the second element.
[0216] As the central shaft is withdrawn from the expandable
section, the peg of the first expandable element can be forced
upward, forcing the first expandable element upward. As the central
shaft is withdrawn from the expandable section, the peg of the
first expandable element can be forced upward, as shown by arrow in
FIG. 88, forcing the second expandable element downward.
[0217] As the central shaft is withdrawn from the expandable
section, the peg of the second expandable element can be forced
downward, forcing the second expandable element upward, as shown by
arrow in FIG. 88.
[0218] FIG. 94 illustrates that the expandable element devices can
be substantially triangular from a lateral perspective. The
expandable elements can be slidably attached to each other. The
expandable attachment device can have multiple expandable elements.
A compressive force, for example including a proximally directed
force applied to the distal end (as shown by arrow) and/or the
distal expandable element, can force the expandable elements to
radially expand, as shown by arrows.
[0219] FIG. 95 illustrates that the distal end of the expandable
attachment device, for example the tip, can have a transverse
cross-section that can be round, circular, oval, square,
rectangular, triangular, or combinations thereof. The expandable
section can have a transverse cross-section that can be round,
circular, oval, square, rectangular, triangular, or combinations
thereof FIG. 96 illustrates a variation of the expandable
section.
[0220] FIG. 97 illustrates that the expandable section in the
radially contracted configuration can have a straight expandable
section axes. FIG. 98 illustrates that the expandable section in a
radially expanded configuration can have a straight or curved
expandable section axis, and/or that the expandable section axis
can be at an angle with respect to the expandable section axis in
the radially contracted configuration.
[0221] FIGS. 99 and 100 illustrates that the expandable section can
have a series of expandable elements having a slidably attached
center shaft therethrough. The center shaft can have a center shaft
anchor. The center shaft anchor can have a larger diameter than the
diameter of the longitudinal channel. Teeth can radially extend
from the expandable elements, for example from at least opposite
sides of alternating expandable elements, as shown.
[0222] FIGS. 101 and 102 illustrate that the expandable elements
can have guide rails. The guide rails can slidably attach to
receiving elements on adjacent expandable elements. The
longitudinal channel in at least every other expandable element can
be elongated in the transverse direction.
[0223] FIGS. 103 and 104 illustrate that the expanding element can
have one or two guide rails on each surface adjacent to another
expanding element when assembles. The cross-section of the
longitudinal channel in an individual expanding element can be, for
example, circular, oval, square, rectangular, or combinations
thereof.
[0224] FIG. 105 illustrates that the expandable element can have
one, two or more guide grooves on each surface adjacent to another
expanding element when assembled. The guide grooves can be
configured to slidably attach to the guide rails.
[0225] FIG. 106 illustrates that the expandable element can have
one or more contouring channels. The contouring channels can be a
defined, substantially closed volume within the expandable element.
The contouring channels can deform, for example, due to force
applied against the teeth during use. When deformed, the contouring
channel can, for example, reduce the stress applied on the
neighboring tissue when implanted compared to the expandable
element in a non-deformed configuration.
[0226] FIG. 107 illustrates an expandable element having a number
of contouring channel extending radially away from the expandable
element channel. The contouring channels can be configured as slots
open to the outside of the expandable element.
[0227] FIG. 108 illustrates that the distal end cap can be distal
to the most distal expandable element. For example, the distal end
cap can be, or be attached to, the center shaft anchor.
[0228] FIG. 109 illustrates that a longitudinally compressive
force, as shown by arrow, can be delivered through the distal end
cap. The expandable elements can then radially expand, as shown by
arrows.
[0229] FIGS. 110 and 111 illustrate the expandable section having
nine and five expandable elements, respectively.
[0230] FIGS. 112 and 113 illustrates that the center shaft can be
configured to have one or more alternately oppositely facing
integral wedges. The expandable section can have one or more
expandable elements. The expandable elements can have guide rails
on the proximal ends and guide grooves on the distal ends. The
guide grooves and guide rails can constrain relative motion between
the expandable elements to a single degree of freedom (e.g.,
lateral motion). The internal surfaces of the expandable elements
can have alternately oppositely facing internal ramps that can be
configured to abut the integral wedges.
[0231] FIG. 113 illustrates that the center shaft can be translated
relative to the expandable section, for example with the center
shaft being translated out of the expandable section. The
expandable elements can then radial expand in opposite directions
as the adjacent expandable elements, as shown by arrows.
[0232] FIG. 114 illustrates that the expandable element can have
one or two guide grooves in the distal end of the expandable
element. The guide grooves can be notches in the wall around the
longitudinal channel. The expandable element can have one or two
guide rails at the proximal end of the expandable element. The
guide rails can be configured to slidably attach to the guide
grooves when one expandable element in stacked on another
expandable element.
[0233] FIG. 115 illustrates that the internal ramp can be a slope
on the internal surface of the longitudinal channel. The thread can
be oil a single side of the expandable element.
[0234] FIGS. 116 and 117 illustrate that when the integral wedges
of the center shaft press into the internal ramps of the expandable
elements, as shown by arrows in FIG. 117, the expandable elements
can be pushed radially outward by the integral wedges, as shown by
arrows.
[0235] FIG. 118 illustrates that the expandable section can have
first, second, third and more expandable elements that can be cams
or other offset-rotation elements. FIG. 119 illustrates that the
distal end can be rotated, as shown by arrow. The expandable
elements can then radially translate or expand, as shown by arrows.
The expandable elements can translate at different timings, so that
the
[0236] FIG. 120a illustrates that the expandable elements can have
a center shaft extending through the expandable elements. The
center shaft can be offset from the center of area of the
expandable element in the plane transverse to the expandable
attachment device axis.
[0237] FIG. 120b illustrates that the expandable section in a
radially contracted configuration can have all of the expandable
elements substantially aligned along the expandable attachment
device axis.
[0238] FIG. 120c illustrates that the expandable section can be
radially expanded by rotating the center shaft and/or rotating the
expandable elements around the center shaft. The cam expandable
elements can splay and radially expand.
[0239] FIG. 121 illustrates that the expandable attachment device
can have multiple expandable elements eccentrically attached to a
center shaft, and/or with lobed configurations.
[0240] FIGS. 122 through 124 illustrate that the expandable
attachment device can have one through four expandable elements
eccentrically attached to a center shaft (not shown). The
expandable elements can have teeth radially extending from the
expandable elements.
[0241] FIGS. 125 through 127 illustrate the expandable attachment
device with eccentrically attached expandable elements in a
radially expanded configuration.
[0242] FIGS. 128 and 129 illustrate that the expandable section can
have a first, second and third expandable element. The expandable
elements can be slidably attached by interlocking rails and tracks.
The rails and tracks can constrain relative motion between adjacent
expandable elements to one degree of freedom (e.g., vertical
relative motion).
[0243] The expandable elements can have longitudinal channels
configured, for example as shown, to receive a multi-lobed center
shaft and be controllable as shown in FIGS. 128 through 133. The
configuration of the longitudinal channel in each expandable
element can be the same or different as the other expandable
elements. For example, the first expandable element and the third
expandable element can have substantially identically configured
longitudinal channels. The second expandable element can have a
longitudinal channel configured to be a horizontally reversed
configuration of the longitudinal channel of the first expandable
element. The second expandable element can have a longitudinal
channel configured to be-about a 180.degree. rotation of the
longitudinal channel of the first expandable element. The center
shaft can have a first lobe and a second lobe.
[0244] FIGS. 130 and 131 illustrate that the center shaft can be
rotated, as shown by arrow. When the center shaft is rotated, the
lobes can exert forces against the expandable elements. The
expandable elements can be translated in a direction substantially
perpendicular to the longitudinal axis of the center shaft. For
example, the first and third expandable elements can translate
toward the up, as shown by arrows. The second expandable element
can translate down, as shown by arrows.
[0245] FIGS. 132 and 133 illustrates that the center shaft can be
rotated in the opposite direction as shown in FIGS. 130 and 131.
The expandable elements can translate in the opposite direction as
shown from FIG. 131.
[0246] FIGS. 134 and 135 illustrate a center shaft that can have
alternating first lobes and second lobes along the length of the
center shaft. The first lobes can have a first lobe axis. The
second lobes can have a second lobe axis. When viewed in the same
plane, the angle between the first lobe axis and the second lobe
axis can be a lobe angle. The lobe angle can be from about
90.degree. to about 180.degree.. The first lobes can be actuated in
an opposite rotational direction than the second lobes.
[0247] FIG. 136 illustrates an expandable section that can have a
first expandable element that can translate in the opposite
direction of the second expandable element when the center shaft is
rotated. The first expandable element can have first element teeth.
The second expandable element can have second element teeth. The
element teeth can extend radially inward in the longitudinal
channel. The first element teeth can be on the opposite side of the
longitudinal channel as the second element teeth. The center shaft
can have gear teeth extending radially outward. The gear teeth can
engage the first element teeth can the second element teeth.
[0248] FIGS. 137 through 139 illustrate that when the center shaft
is rotated, the first expandable element can translate up at the
same rate that the second expandable element can translate
down.
[0249] FIG. 140 illustrates an expandable section that can have
thread or teeth on one, two, three or more spines extending
radially from the wall of the expandable section. In a radially
contracted configuration, the wall can have multiple folds, for
example two folds between each two adjacent spines. The folds can
be unevenly spaced between the adjacent spines.
[0250] FIG. 141 illustrates that the wall can have two folds
between each two adjacent spines. The folds can be evenly spaced
between the adjacent spines.
[0251] FIG. 142 illustrates that the walls can have one fold
between adjacent spines. The spines can extend radially inward
and/or outward from the wall.
[0252] FIGS. 143 and 144 illustrate that the expandable section
(shown for exemplary purposes as the expandable section of FIG.
141) can be loaded on the center shaft of an expandable attachment
device. The expandable section can be placed between a first cone
and a second cone on the expandable attachment device. The
expandable attachment device can have a mandrel. The second cone
can be part of the mandrel.
[0253] FIG. 145 illustrates that the mandrel can be pushed, as
shown by arrow, toward the expandable section. The expandable
section can radially expand as shown by arrow.
[0254] The distal end can be configured to attach to a separate
device, such as a fixation rod or plate. The distal end can be
threaded.
[0255] FIG. 146 illustrates that the expandable attachment device
can have a first expandable section and a second expandable
section. Each expandable section can be between a first cone and a
second cone, and can be radially expanded as described herein,
including as shown in FIG. 145.
[0256] FIGS. 147 through 149 illustrate the expandable sections of
FIGS. 140 through 142, respectively, loaded on the center shaft of
the expandable attachment device.
[0257] FIGS. 150 and 153 illustrate that the expandable section can
have about four angled ports. Each port can have a joint. Between
two adjacent ports can be an individual expandable segment, for
example the first expandable segment and the second expandable
segment, as shown.
[0258] FIG. 152 illustrates that a longitudinally compressive
force, as shown by arrows, can be applied to the expandable
section. The expandable segments can rotate, as shown by arrows,
around the adjacent joints. The ports can close. In the radially
expanded configuration, the expandable section can have a distal
end shifted laterally from the proximal end.
[0259] FIG. 153 illustrates that the expandable section can have
larger ports and/or the expandable section cali be over compressed,
causing deformation after the ports have closed. The distal end and
the proximal end of the expandable section can be laterally
aligned.
[0260] FIG. 154 illustrates a side view of a spine. FIG. 155
illustrates that harder, cortical bone surrounds softer, cancellous
bone in the vertebra.
[0261] FIG. 156 illustrates that the expandable attachment device
can be translated and/or rotated into the pedicle and/or into the
vertebral body. The expanded section can be positioned in the
cortical bone.
[0262] FIGS. 157 and 158 illustrate that the expandable section can
be radially expanded, for example in the cancellous bone of the
pedicle and/or the vertebral body. The radius of the radially
expanded section can be larger than the entry hole created to
insert the attachment device into the vertebra.
[0263] The distal end can extend from the bone. A separate device,
such as a fixation rod or plate, can be attached to the distal
end.
[0264] FIG. 159 illustrates that an expandable attachment device
can be used to treat a long bone break, such as in the femur or
humerus. The expandable attachment device can be inserted into the
cancellous and/or cortical part of the bone. The expandable
attachment device can be positioned to have a first expandable
section on a first side of the bone fracture. The expandable
attachment device can be positioned to have a second expandable
section on a second side of the bone fracture. The expandable
attachment device can have an unexpandable section between the
first and second expandable sections. The unexpandable section can
be positioned across the bone fracture.
[0265] FIG. 160 illustrates that a first expandable attachment
device 22a can be placed in a first section of the bone (e.g., the
femur head). A second expandable attachment device 22b can be
placed in a second section of the bone. The second expandable
attachment device 22b can have a collar configured to fixedly
receive the unexpandable section of the first expandable attachment
device. The unexpandable section of the first expandable attachment
device 22a can be fixedly attached to the collar.
[0266] FIGS. 161 and 162 illustrates that the expandable attachment
device can have an end attachment configured to be attached, as
shown by arrow, to the distal end. For example, the expandable
attachment device can be positioned in a bone and radially
expanded. The end attachment can be attached to the distal end, as
shown in FIG. 164. The end attachment can be configured to attach
to a separate device, such as a fixation rod or plate, as shown in
FIG. 163.
[0267] FIG. 165 through 166 illustrates that the expandable
attachment device can be deployed by radially expanding the first
expandable section at a first end, and concurrently or
subsequently, radially expanding, the second expandable section at
a second end.
[0268] FIGS. 168 and 169 illustrate that the expandable attachment
device can be positioned so the first expandable section can be
radially expanded in the pedicle or vertebral body. The second
expandable section can be radially expanded in the pedicle,
vertebral body, or outside the bone, for example in the soft tissue
or in a virtual space. A separate device, such as a fixation rod or
plate can be attached to the second expandable section.
[0269] FIGS. 170 through 172 illustrate that a fixation plate can
be attached to the anterior side of the spine. FIG. 171 illustrates
that the expandable attachment devices can be attached to the
fixation plate and the first expandable section can be radially
expanded. FIG. 172 illustrates that the second expandable sections
of the expandable attachment devices can be positioned in the
cancellous bone. The second expandable sections can be radially
expanded, as shown by arrows, in the cancellous bone, for example
in the vertebral body.
[0270] FIG. 173 illustrates that the deployment tool can have a
first handle rotatably attached to a second handle. Rotating the
first handle and the second handle towards each other, as shown by
arrows, can result in longitudinal compression of the expandable
section of the expandable attachment device. See the incorporated
applications for additional elements of the deployment tool. The
expandable attachment device can be removably attached to the
deployment head.
[0271] FIG. 174 illustrates that an oral space can have a missing
tooth. The missing tooth can be surrounded on one side, both sides
or neither side, by teeth. The gum, bone, and teeth roots are also
shown.
[0272] FIG. 175 illustrates that the expandable attachment device
can be screwed (e.g., rotation and translation), as shown by
arrows, into the missing tooth space in the bone. The unexpandable
thread can compact or cut bone as the expandable attachment device
is inserted into the missing tooth space in the bone. FIG. 176
illustrates that the expandable support device can be fully
inserted into the bone. The distal end can extend above the
gum.
[0273] FIG. 177 illustrates that the expandable section can be
radially expanded, as shown by arrows, for example with the
expandable support device fully inserted into the bone.
[0274] FIG. 178 illustrates that a replacement tooth can be fixedly
or removably attached to the distal end. The distal end can be
configured to attach to the replacement tooth (e.g., thread, one or
more latches, clasps, locks). The replacement tooth can be
positioned between the adjacent teeth. The space between the
replacement tooth and the gum can be partially or completely filled
by a filler, for example a biocompatible cement (e.g., a bone
cement).
[0275] FIG. 179 illustrates that the expandable attachment device
can have unidirectional and/or one-way teeth along all or part of
the length of the expandable section. The expandable section can be
along substantially the entire length of the expandable attachment
device, for example, except for the distal end configured to attach
to the replacement tooth.
[0276] FIG. 180 illustrates that the expandable section can be
radially expanded, as shown by arrows. The replacement tooth can
then be attached as shown in FIG. 178.
[0277] FIGS. 181 and 182 illustrate that the expandable section can
have expandable threads around one or more sections of the
expandable section (e.g., for example on opposite sides of the
expandable section, as shown). The distal wedge and/or the proximal
wedge can have threads on the internal diameter or be threadless on
the internal diameter. The internal threads can engage the proximal
length of the center shaft (e.g., the proximal length of the center
shaft have a smaller, larger or the same diameter as compared to
the diameter of the distal length of the center shaft). The
proximal wedge can have an internal diameter that can be larger
than the threads on the center shaft so the proximal wedge can
slide freely over the distal length of the center shaft and/or the
proximal length of the center shaft.
[0278] FIGS. 183 and 184 illustrate that the outer diameter of the
unexpandable section can be substantially equivalent to the outer
diameters of the expandable section (e.g., in a radially contracted
configuration) and/or the wedges. The outer diameter of the
expandable section (e.g., in a radially contracted configuration)
can be slightly larger than, smaller than, or substantially
equivalent to the outer diameter of the unexpandable section.
[0279] The internal diameter of the expandable section and the
internal diameter of one or more of the wedges (e.g., shown as only
the proximal wedge in FIGS. 183 and 184) can have internal threads
and/or teeth, for example, configured to engage threads and/or
teeth on the center shaft.
[0280] The center shaft can have a reduced diameter (as shown) at a
length near the longitudinal middle of the center shaft. The
internal threads or teeth (e.g., on the inner diameter of the
expandable section) might not engage the center shaft along the
length having the reduced diameter, for example because of no
geometric overlap and/or the absence of teeth or threads along the
outer diameter of the center shaft along the length having the
reduced diameter.
[0281] FIGS. 185, 186 and 187 illustrate that the wedges can be
segmented. For example, the proximal wedge can have adjacent and/or
attached proximal wedge first and second segments. The distal wedge
can have adjacent and/or attached distal wedge first and second
segments.
[0282] The wedge segments can be configured to individually or
jointedly fixedly (e.g., via ratcheting on the center shaft and/or
wedge) or releasably attach to the center shaft and/or expandable
section. For example, the expandable section and/or center shaft
can have one or more male or female configurations (e.g., guide
slots 124, such as T-slots, as shown) and the wedge segment can
have one or more corresponding female or male segments (e.g., wedge
rails, such as T-extensions, as shown). When the proximal wedge is
forced distally and/or the distal wedge is forced proximally, one
or both wedges can force the expandable section to radially expand.
When the proximal wedge is forced proximally and/or the distal
wedge is forced distally, one or both wedges can force the
expandable section to radially contract.
[0283] Any or all elements of the expandable attachment device
and/or other devices or apparatuses described herein can be made
from, for example, a single or multiple stainless steel alloys,
nickel titanium alloys (e.g., Nitinol), cobalt-chrome alloys (e.g.,
ELGILOY.RTM. from Elgin Specialty Metals, Elgin, Ill.;
CONICHROME.RTM. from Carpenter Metals Corp., Wyomissing, Pa.),
nickel-cobalt alloys (e.g., MP35N.RTM. from Magellan Industrial
Trading Company, Inc., Westport, Conn.), molybdenum alloys (e.g.,
molybdenum TZM alloy, for example as disclosed in International
Pub. No. WO 03/082363 A2, published 9 Oct. 2003, which is herein
incorporated by reference in its entirety), tungsten-rhenium
alloys, for example, as disclosed in International Pub. No. WO
03/082363, polymers such as polyethylene teraphathalate (PET),
polyester (e.g., DACRON.RTM. from E. I. Du Pont de Nemours and
Company, Wilmington, Del.), poly ester amide (PEA), polypropylene,
aromatic polyesters, such as liquid crystal polymers (e.g.,
Vectran, from Kuraray Co., Ltd., Tokyo, Japan), ultra high
molecular weight polyethylene (i.e., extended chain, high-modulus
or high-performance polyethylene) fiber and/or yarn (e.g.,
SPECTRA.RTM. Fiber and SPECTRA.RTM. Guard, from Honeywell
International, Inc., Morris Township, N.J., or DYNEEMA.RTM. from
Royal DSM N.V., Heerlen, the Netherlands), polytetrafluoroethylene
(PTFE), expanded PTFE (ePTFE), polyether ketone (PEK), polyether
ether ketone (PEEK), poly ether ketone ketone8 (PEKK) (also poly
aryl ether ketone ketone), nylon, polyether-block co-polyamide
polymers (e.g., PEBAX.RTM. from ATOFINA, Paris, France), aliphatic
polyether polyurethanes (e.g., TECOFLEX.RTM. from Thermedics
Polymer Products, Wilmington, Mass.), polyvinyl chloride (PVC),
polyurethane, thermoplastic, fluorinated ethylene propylene (FEP),
absorbable or resorbable polymers such as polyglycolic acid (PGA),
poly-L-glycolic acid (PLGA), polylactic acid (PLA), poly-L-lactic
acid (PLLA), polycaprolactone (PCL), polyethyl acrylate (PEA),
polydioxanone (PDS), and pseudo-polyamino tyrosine-based acids,
extruded collagen, silicone, zinc, echogenic, radioactive,
radiopaque materials, a biomaterial (e.g., cadaver tissue,
collagen, allograft, autograft, xenograft, bone cement, morselized
bone, osteogenic powder, beads of bone) any of the other materials
listed herein or combinations thereof. Examples of radiopaque
materials are barium sulfate, zinc oxide, titanium, stainless
steel, nickel-titanium alloys, tantalum and gold.
[0284] Any or all elements of the expandable attachment device
and/or other devices or apparatuses described herein, can be, have,
and/or be completely or partially coated with agents and/or a
matrix a matrix for cell ingrowth or used with a fabric, for
example a covering (not shown) that acts as a matrix for cell
ingrowth. The matrix and/or fabric can be, for example, polyester
(e.g., DACRON.RTM. from E. I. Du Pont de Nemours and Company,
Wilmington, Del.), poly ester amide (PEA), polypropylene, PTFE,
ePTFE, nylon, extruded collagen, silicone, any other material
disclosed herein, or combinations thereof.
[0285] The expandable attachment device and/or elements of the
expandable attachment device and/or other devices or apparatuses
described herein and/or the fabric can be filled, coated, layered
and/or otherwise made with and/or from cements, fillers, glues,
and/or an agent delivery matrix known to one having ordinary skill
in the art and/or a therapeutic and/or diagnostic agent. Any of
these cements and/or fillers and/or glues can be osteogenic and
osteoinductive growth factors.
[0286] Examples of such cements and/or fillers includes bone chips,
demineralized bone matrix (DBM), calcium sulfate, coralline
hydroxyapatite, biocoral, tricalcium phosphate, calcium phosphate,
polymethyl methacrylate (PMMA), biodegradable ceramics, bioactive
glasses, hyaluronic acid, lactoferrin, bone morphogenic proteins
(BMPs) such as recombinant human bone morphogenetic proteins
(rhBMPs), other materials described herein, or combinations
thereof.
[0287] The agents within these matrices can include any agent
disclosed herein or combinations thereof, including radioactive
materials; radiopaque materials; cytogenic agents; cytotoxic
agents; cytostatic agents; thrombogenic agents, for example
polyurethane, cellulose acetate polymer mixed with bismuth
trioxide, and ethylene vinyl alcohol; lubricious, hydrophilic
materials; phosphor cholene; anti-inflammatory agents, for example
non-steroidal anti-inflammatories (NSAIDs) such as cyclooxygenase-1
(COX-1) inhibitors (e.g., acetylsalicylic acid, for example
ASPIRIN.RTM. from Bayer AG, Leverkusen, Germany; ibuprofen, for
example ADVIL.RTM. from Wyeth, Collegeville, Pa.; indomethacin;
mefenamic acid), COX-2 inhibitors (e.g., VIOXX.RTM. from Merck
& Co., Inc., Whitehouse Station, N.J.; CELEBREX.RTM. from
Pharmacia Corp., Peapack, N.J.; COX-1 inhibitors);
immunosuppressive agents, for example Sirolimus (RAPAMUNE.RTM.,
from Wyeth, Collegeville, Pa.), or matrix metalloproteinase (MMP)
inhibitors (e.g., tetracycline and tetracycline derivatives) that
act early within the pathways of an inflammatory response. Examples
of other agents are provided in Walton et al, Inhibition of
Prostoglandin E.sub.2 Synthesis in Abdominal Aortic Aneurysms,
Circulation, Jul. 6, 1999, 48-54; Tambiah et al, Provocation of
Experimental Aortic Inflammation Mediators and Chlamydia
Pneumoniae, Brit. J. Surgery 88 (7), 935-940; Franklin et al,
Uptake of Tetracycline by Aortic Aneurysm Wall and Its Effect on
Inflammation and Proteolysis, Brit. J. Surgery 86 (6), 771-775; Xu
et al, Sp1 Increases Expression of Cyclooxygenase-2 in Hypoxic
Vascular Endothelium, J. Biological Chemistry 275 (32) 24583-24589;
and Pyo et al, Targeted Gene Disruption of Matrix
Metalloproteinase-9 (Gelatinase B) Suppresses Development of
Experimental Abdominal Aortic Aneurysms, J. Clinical Investigation
105 (11), 1641-1649 which are all incorporated by reference in
their entireties.
[0288] Other examples of fractures types that can be treated with
the disclosed device and method include Greenstick fractures,
transverse fractures, fractures across growth plates, simple
fractures, wedge fractures, complex fractures, compound fractures,
complete fractures, incomplete fractures, linear fractures, spiral
fractures, transverse fractures, oblique fractures, comminuted
fractures, impacted fractures, and soft tissue tears, separations
(e.g., avulsion fracture), sprains, and combinations thereof.
Plastic deformations of bones can also be treated with the
disclosed device and method.
[0289] Other examples of bones that can be treated with the
disclosed device and method include the fingers (e.g., phalanges),
hands (e.g., metacarpals, carpus), toes (e.g., tarsals), feet
(metatarsals, tarsus), legs (e.g., femur, tibia, fibula), arms
(e.g., humerus, radius, ulna), scapula, coccyx, pelvis, clavicle,
scapula, patella, sternum, ribs, or combinations thereof.
[0290] Devices, elements and configurations disclosed as expandable
support devices in the following applications can be used for the
expandable section in the present application, and the following
applications are incorporated by reference herein in their
entireties: PCT Application No. 2005/034115 filed 21 Sep. 2005, PCT
Application No. 2006/016553 filed 27 Apr. 2006, PCT Application No.
2005/034742 filed 26 Sep. 2005, PCT Application No. 2005/034728
filed 26 Sep. 2005, PCT Application 2005/037126 filed 12 Oct. 2005,
PCT Application No. 2006/62333 filed 19 Dec. 2006, PCT Application
No. 2006/038920 filed 4 Oct. 2006, PCT Application No. 06/027601
filed 14 Jul. 2006, PCT Application No. 2006/62201 filed 15 Dec.
2006, PCT Application No. 2006/62339 filed 19 Dec. 2006, PCT
Application No. 2006/48667 filed 19 Dec. 2006, and U.S. patent
application Ser. No. 11/457,772 filed 14 Jul. 2006.
[0291] All dimensions shown herein are exemplary. The dimensions
shown herein can at least be expanded to ranges from about 50% to
about 150% of the exemplary dimension shown herein, more narrowly
from about 75% to about 125% of the exemplary dimension shown
herein.
[0292] The use of the term "radial expansion" herein refers to both
a volumetric increase of an element, or an increase in the radial
dimension of the element itself, or the increase in the maximum
radius of the element as measured from the expandable attachment
device axis.
[0293] Any elements described herein as singular can be pluralized
(i.e., anything described as "one" can be more than one). Any
species element of a genus element can have the characteristics or
elements of any other species element of that genus. The
above-described configurations, elements or complete assemblies and
methods and their elements for carrying out the invention, and
variations of aspects of the invention can be combined and modified
with each other in any combination.
* * * * *