U.S. patent application number 15/683580 was filed with the patent office on 2017-12-07 for expandable support device and method of use.
The applicant listed for this patent is E. Skott GREENHALGH, Michael P. IGOE, Robert A. KIEFER, John-Paul ROMANO. Invention is credited to E. Skott GREENHALGH, Michael P. IGOE, Robert A. KIEFER, John-Paul ROMANO.
Application Number | 20170348115 15/683580 |
Document ID | / |
Family ID | 37638007 |
Filed Date | 2017-12-07 |
United States Patent
Application |
20170348115 |
Kind Code |
A1 |
GREENHALGH; E. Skott ; et
al. |
December 7, 2017 |
EXPANDABLE SUPPORT DEVICE AND METHOD OF USE
Abstract
An expandable support device for tissue repair is disclosed. The
device can be used to repair hard or soft tissue, such as bone or
vertebral discs. The device can have multiple flat sides that
remain flat during expansi A method of repairing tissue is also
disclosed. Devices and methods for adjusting (e.g., removing,
repositioning, resizing) deployed orthopedic expandable support
devices are also disclosed. The expandable support devices can be
engaged by an engagement device. The engagement device can
longitudinally expand the expandable support device. The expandable
support device can be longitudinally expanded until the expandable
support device is substantially in a pre-deployed configuration.
The expandable support device can be then be physically translated
and/or rotated.
Inventors: |
GREENHALGH; E. Skott;
(Gladwyne, PA) ; ROMANO; John-Paul; (Chalfont,
PA) ; IGOE; Michael P.; (Windham, NH) ;
KIEFER; Robert A.; (Quakertown, PA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
GREENHALGH; E. Skott
ROMANO; John-Paul
IGOE; Michael P.
KIEFER; Robert A. |
Gladwyne
Chalfont
Windham
Quakertown |
PA
PA
NH
PA |
US
US
US
US |
|
|
Family ID: |
37638007 |
Appl. No.: |
15/683580 |
Filed: |
August 22, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12014006 |
Jan 14, 2008 |
9770339 |
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15683580 |
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PCT/US2006/027601 |
Jul 14, 2006 |
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12014006 |
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60699576 |
Jul 14, 2005 |
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60752183 |
Dec 19, 2005 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2310/00137
20130101; A61F 2230/0054 20130101; A61B 17/8858 20130101; A61F
2/442 20130101; A61F 2002/30176 20130101; A61F 2002/30677 20130101;
A61F 2310/00029 20130101; A61F 2/4611 20130101; A61F 2230/0056
20130101; A61F 2002/30579 20130101; A61F 2310/00952 20130101; A61F
2002/30787 20130101; A61F 2002/30092 20130101; A61F 2002/4627
20130101; A61F 2/4455 20130101; A61F 2002/30978 20130101; A61F
2002/30136 20130101; A61F 2230/0028 20130101; A61F 2002/30593
20130101; A61F 2002/4629 20130101; A61F 2002/30177 20130101; A61B
17/7098 20130101; A61F 2230/0004 20130101; A61B 2017/00004
20130101; A61F 2310/00017 20130101; A61F 2002/3097 20130101; A61F
2002/30166 20130101; A61F 2310/00023 20130101; A61F 2210/0014
20130101 |
International
Class: |
A61F 2/44 20060101
A61F002/44; A61B 17/88 20060101 A61B017/88; A61F 2/46 20060101
A61F002/46 |
Claims
1. A method for adjusting an expandable support device deployed in
an orthopedic treatment site, the method comprising: engaging the
expandable support device with an engagement device; delivering a
force through the engagement device to the expandable support
device; and contracting the expandable support device.
2. The method of claim 1, further comprising withdrawing the
expandable support device from the orthopedic treatment site.
3. The method of claim 1, further comprising reshaping the
expandable support device within the orthopedic treatment site.
4. The method of claim 1, further comprising repositioning the
expandable support device within the orthopedic treatment site.
5. The method of claim 1, wherein contracting comprises radially
contracting.
6. The method of claim 1, wherein the force comprises a
longitudinally tensile force applied to the expandable support
device.
7. The method of claim 1, further comprising detaching the
engagement device from the expandable support device.
8. A method for removing an expandable support device deployed in
an orthopedic treatment site, the method comprising: applying a
longitudinal tension to the expandable support device; radially
contracting the expandable support device; and withdrawing the
expandable support device from the orthopedic treatment site.
9. The method of claim 8, further comprising engaging the
expandable support device with an engagement device.
10. The method of claim 8, wherein the applying a longitudinal
tension to the expandable support device comprises delivering a
force through the engagement device to the expandable support
device.
11. The method of claim 8, wherein the longitudinal tensioning
causes the radially contracting.
12. The method of claim 8, further comprising longitudinally
expanding the expandable support device.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of U.S. patent application
Ser. No. 12/014,006, filed Jan. 14, 2008, which is a continuation
of PCT Application No. PCT/US2006/027601, filed Jul. 14, 2006,
which claims the benefit to U.S. Provisional Application Nos.
60/699,576 filed Jul. 14, 2005, and 60/752,183 filed Dec. 19, 2005,
which are all herein incorporated by reference in their
entireties.
BACKGROUND OF THE INVENTION
[0002] This invention relates to devices for providing support for
biological tissue, for example to repair spinal compression
fractures, and methods of using the same.
[0003] Vertebroplasty is an image-guided, minimally invasive,
nonsurgical therapy used to strengthen a broken vertebra that has
been weakened by disease, such as osteoporosis or cancer.
Vertebroplasty is often used to treat compression fractures, such
as those caused by osteoporosis, cancer, or stress.
[0004] Vertebroplasty is often performed on patients too elderly or
frail to tolerate open spinal surgery, or with bones too weak for
surgical spinal repair. Patients with vertebral damage due to a
malignant tumor may sometimes benefit from vertebroplasty. The
procedure can also be used in younger patients whose osteoporosis
is caused by long-term steroid treatment or a metabolic
disorder.
[0005] Vertebroplasty can increase the patient's functional
abilities, allow a return to the previous level of activity, and
prevent further vertebral collapse. Vertebroplasty attempts to also
alleviate the pain caused by a compression fracture.
[0006] Vertebroplasty is often accomplished by injecting an
orthopedic cement mixture through a needle into the fractured bone.
The cement mixture can leak from the bone, potentially entering a
dangerous location such as the spinal canal. The cement mixture,
which is naturally viscous, is difficult to inject through small
diameter needles, and thus many practitioners choose to "thin out"
the cement mixture to improve cement injection, which ultimately
exacerbates the leakage problems. The flow of the cement liquid
also naturally follows the path of least resistance once it enters
the bone--naturally along the cracks formed during the compression
fracture. This further exacerbates the leakage.
[0007] The mixture also fills or substantially fills the cavity of
the compression fracture and is limited to certain chemical
composition, thereby limiting the amount of otherwise beneficial
compounds that can be added to the fracture zone to improve
healing. Further, a balloon must first be inserted in the
compression fracture and the vertebra must be expanded before the
cement is injected into the newly formed space.
[0008] A vertebroplasty device and method that eliminates or
reduces the risks and complexity of the existing art is desired. A
vertebroplasty device and method that is not based on injecting a
liquid directly into the compression fracture zone is desired.
BRIEF SUMMARY OF THE INVENTION
[0009] An expandable support device for performing completely
implantable spinal repair is disclosed. The device may include a
near end portion and a far end portion with a number of backbone
struts extending therebetween. The near and far end portions may be
closed or have passage openings. In one variation of the invention
the end portions can be non-expandable and can cause the implant to
form a tapered profile when expanded. Adjacent backbone struts in
the implant can be connected by a number of deformable support
struts. The adjacent backbone struts can be affixed together or
integral (e.g., when laser cut from a tube or other extrusion type
piece).
[0010] The structure of the implant device can permit expansion in
a number of directions. Variations of the implant can assume
different cross-sectional shapes , where such shapes include a
square, rectangular, triangular, or any such type of polygon where
the sides are defined by the adjacent backbone struts and
associated connecting support struts. Furthermore, the shapes may
also be rounded, tapered, rectangular (e.g., where the aspect ratio
may not be 1 to 1.)
[0011] An expandable support device for placement within or between
spinal vertebral bodies is disclosed. The device can have a
radially non-expandable near end portion, a radially non-expandable
far end portion and a longitudinal axis extending therebetween. The
device can have backbone struts parallel to the longitudinal axis.
The backbone struts can each have a near end integral with the near
end portion and a far end integral with the far end portion. The
device can have deformable support struts located between each
adjacent backbone strut. The support struts can have a support
strut width perpendicular to the longitudinal axis. The support
struts can have a support strut thickness parallel to the
longitudinal axis. The support strut width can be greater than the
support strut thickness. Each support strut can be deformable such
that, upon longitudinal expansion of the expandable support device
from a radially expanded configuration, the adjacent backbone
struts approach each other while the support struts deform. One or
more of the support struts can have a bend when the device is in a
radially contracted configuration. The bend can define an edge
having a surface that is coincidental with the outer surface of the
expandable support device. When the device is in a radially
contracted configuration a first length of the backbone struts can
be the same shape as the first length of the backbone struts when
the device is in a radially expanded configuration. When the device
is in a radially expanded configuration, the device can have a
lumen along the longitudinal axis. The lumen can be at least
partially filled with a filler. An outer cross section of the
device perpendicular to the longitudinal axis when the device is in
a radially expanded configuration can be quadrilateral. Lengths of
at least two backbone struts can be parallel with each other when
the device is in a radially expanded configuration.
[0012] An expandable support device for placement within or between
spinal vertebral bodies is disclosed. The device can have a
radially non-expandable near end portion, a radially non-expandable
far end portion and a longitudinal axis extending therebetween. The
device can have backbone struts parallel to the longitudinal axis.
The backbone struts can each have a near end integral with the near
end portion and a far end integral with the far end portion. The
device can have deformable support struts located between each
adjacent backbone strut. Each support strut can be deformable such
that, upon longitudinal expansion of the expandable support device
from a radially expanded configuration, the adjacent backbone
struts approach each other while the support struts deform. When
the device is in a radially expanded configuration, the device can
have a lumen along the longitudinal axis. The lumen can be at least
partially filled with a filler. An outer cross section of the
device perpendicular to the longitudinal axis when the device is in
a radially expanded configuration can be quadrilateral. At least
one support strut can have a bend when the device is in a radially
contracted configuration. The bend can defines an edge having a
surface that is coincidental with the outer surface of the
expandable support device.
[0013] An expandable support device for placement within or between
spinal vertebral bodies is disclosed. The device can have a
radially non-expandable near end portion, a radially non-expandable
far end portion and a longitudinal axis extending therebetween. The
device can have backbone struts parallel to the longitudinal axis.
The backbone struts can each have a near end integral with the near
end portion and a far end integral with the far end portion. The
device can have deformable support struts located between each
adjacent backbone strut. At least a first support strut and a
second support strut located between an adjacent pair of backbone
struts can be flat when the device is in a radially expanded
configuration. Each support strut can be deformable such that, upon
longitudinal expansion of the expandable support device from a
radially expanded configuration, the adjacent backbone struts
approach each other while the support struts deform. When the
device is in a radially contracted configuration a first length of
the backbone struts can be the same shape as the first length of
the backbone struts when the device is in a radially expanded
configuration. When the device is in a radially expandable
configuration, the device can have a lumen along the longitudinal
axis. The lumen can be at least partially filled with a filler. An
outer cross section of the device perpendicular to the longitudinal
axis when the device is in a radially expanded configuration can be
quadrilateral. At least one support strut can have a bend when the
device is in a radially contracted configuration. The bend can
define an edge having a surface that is coincidental with the outer
surface of the expandable support device. A flat plane can be
defined by the outer surfaces of the support struts between a first
backbone strut and a second backbone strut adjacent to the first
backbone strut.
[0014] A method for repairing a damaged section of a spine is also
disclosed. The method can include expanding an expandable support
device in a treatment site such as a damaged section of bone (e.g.,
vertebra) or soft tissue (e.g., vertebral disc). The expandable
support device can be loaded on a balloon during the expanding. The
expansion of the device may be accomplished as described herein.
For example, the expansion may include can include inflation of a
balloon-type expansion device. Inflating the balloon can include
inflating the balloon equal to or greater than about 5,000 kPa of
internal pressure, or equal to or greater than about 10,000 kPa of
internal pressure.
[0015] Expandable support devices for orthopedic applications,
deployment tools and methods for using that same that can be
deployed in a minimally invasive procedure are disclosed. For
example, the expandable support devices can be deployed through
0.25 in. to 0.5 in. incisions. The expandable support devices can
be, for example, metal and/or polymer self-assembling, self-forming
structures. Imaging modalities can be used to maneuver the
expandable support device inside the patient.
[0016] Further, expandable support devices, deployment tools and
methods are disclosed for removing, resizing, and repositioning the
expandable support devices are disclosed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] FIG. 1 illustrates a perspective view of a variation of the
implant in an unexpanded configuration.
[0018] FIG. 2 illustrates a perspective view of the variation of
the implant of FIG. 1 in an expanded configuration.
[0019] FIG. 3 illustrates a side view of the variation of the
implant of FIG. 1.
[0020] FIG. 4 shows a variation of the view along line 4-4 in FIG.
3.
[0021] FIG. 5 illustrates a side view of the variation of the
implant of FIG. 1 in an expanded configuration.
[0022] FIG. 6 shows a variation of the view along line 6-6 in FIG.
4
[0023] FIGS. 7 and 8 illustrate a variation of a method for using a
delivery system for the expandable support element.
[0024] FIGS. 9 through 11 illustrate a variation of a method for
accessing a treatment site in the vertebra.
[0025] FIG. 12 illustrates various variations of methods for
deploying the expandable support device to the vertebral
column.
[0026] FIGS. 13 through 15 illustrate a variation of a method for
deploying the expandable support device into the treatment site in
the vertebra.
[0027] FIGS. 16 and 17 illustrate a variation of a method for
deploying the expandable support device into the treatment site in
the vertebra.
[0028] FIGS. 18 and 19 illustrate a variation of a method for
deploying one or more expandable support devices into one or more
treatment sites in the vertebra.
[0029] FIG. 20 illustrates a variation of a method for deploying
the expandable support device into the treatment site in the
vertebra.
[0030] FIG. 21 illustrates a variation of a method for deploying
the expandable support device into the treatment site in the
vertebra.
[0031] FIG. 22 illustrates a variation of a method for deploying
multiple expandable support devices into one or more treatment
sites in the vertebra.
[0032] FIGS. 23 and 24 illustrate a variation of a method for
deploying the expandable support device into the treatment site in
the vertebra.
[0033] FIGS. 25 and 26 illustrate a variation of a method for
deploying the expandable support device between vertebral
bodies.
[0034] FIGS. 27 through 29 illustrate a variation of a method for
adjusting and/or retracting the expandable support device with an
engagement device.
[0035] FIGS. 30 through 32 illustrate a variation of a method for
adjusting and/or retracting the expandable support device with an
engagement device.
[0036] FIGS. 33 and 35 illustrate a variation of a method for
splitting the expandable support device with an engagement
device.
[0037] FIG. 34 illustrates a variation of the engagement device
having a cutting blade.
[0038] FIGS. 36a and 36b illustrate variations of a first portion
and second portion, respectively, of the expandable support device
that has been slit.
[0039] FIG. 37 illustrates a variation of a method for adjusting
and/or retracting the expandable support device.
[0040] FIG. 38 illustrates a cross-sectional view of a method for
deploying the expandable support device in a bone.
[0041] FIGS. 39 through 41 illustrate a variation of a method for
overdeploying the expandable support device.
[0042] FIGS. 42 through 46 illustrate a method for deploying the
expandable support device.
DETAILED DESCRIPTION
[0043] FIGS. 1 and 2 illustrate a biocompatible implant used for
tissue repair, including, but not limited to repair of bone
fractures such as spinal compression fractures, and/or repairing
soft tissue damage, such as herniated/diseased vertebral discs. The
impant can be used to perform vertebroplasty, and/or the implant
can be used as a partial and/or complete vertebra and/or vertebral
disc replacement, and/or for vertebral fixation. The implant can be
an expandable support device 2, for example a stent. The expandable
support device 2 can have a longitudinal axis 4.
[0044] The expandable support devices 2 can be used to provide
structural reinforcement from inside one or more bones, as a
replacement for one or more bones, or between bones. The expandable
support devices can be used for a variety of orthopedic locations,
such as in the vertebral column, for example, to treat compression
fractures. Examples of expandable support devices and methods for
use of expandable support devices, as well as devices for deploying
the expandable support devices include those disclosed in the
following applications which are all incorporated herein in their
entireties: PCT Application Nos. US2005/034115, filed 21 Sep. 2005;
US2005/034742, filed 26 Sep. 2005; US2005/034728, filed 26 Sep.
2005; US2005/037126, filed 12 Oct. 2005; U.S. Provisional
Application Nos. 60/675,543, filed 27 Apr. 2005; 60/723,309, filed
4 Oct. 2005; 60/675,512, filed 27 Apr. 2005; 60/699,577, filed 14
Jul. 2005; 60/699,576, filed 14 Jul. 2005; and 60/752,183 filed 19
Dec. 2005.
[0045] The expandable support device 2 can have a plurality of
backbone struts 12. The backbone struts 12 can connect a near end
portion 13 and a far end portion 14. The backbone struts 12 can
each have a near end and a far end affixed to the respective end
portions 13 and 14. The expandable support device 2 can be
constructed of separate structures that are fixed, integrated or
otherwise joined together. The expandable support device 2 can be
fabricated from a uniform stock of material (e.g., via laser
cutting or electrical discharge machining (EDM)). Adjacent backbone
struts can be joined by a number of deformable support struts 10.
The support struts 10 can have a thinner cross sectional thickness
than most of the remainder of the stent. This feature allows for
pre-determined deformation of the stent 2 to take place.
[0046] The support struts 10 may also serve to distribute load
across the backbone strut. In such cases, the number of support
struts will determine the degree to which the backbone struts are
supported.
[0047] The expansion ratio of the expandable support device 2 can
be, for example, about 3 or about 4 times the initial diameter of
the expandable support device 2. The expansion ratio can be
selected as required for the particular procedure. For example, in
the pre-expanded configuration the expandable support device 2 can
have an initial diameter of about 6.3 mm (0.25 in.), while in the
expanded configuration, the diameter can be about 9.5 mm (0.37
in.). In a further example, the expandable support device 2 can
have an initial diameter of about 5 mm (0.2 in.), while in the
expanded configuration, the diameter can be about 20 mm (0.8
in.).
[0048] In the pre-expanded configuration, the cross-sectional shape
of the expandable support device 2 can be circular, triangular,
oval, rectangular, square, or any type of polygon and/or rounded,
and/or tapered shape. Upon expansion, the expandable support device
2 can form a polygon-type shape, or other shape as discussed
herein.
[0049] FIG. 2 illustrates that the expandable support device 2 can
expand such that the backbone struts 12 can expand away from the
longitudinal axis 4. The backbone struts 12 can remain
substantially parallel to the axis 4. The support struts 10 can be
configured to limit the expansion of the backbone struts 12. The
backbone struts 12 can be configured to prevent the backbone struts
12 from buckling.
[0050] The adjacent backbone struts 12 and accompanying support
struts 10 can form a side of the implant. Although the variation
illustrated in FIGS. 1 through 6 shows four backbone struts 12, and
four support strutsl0 per adjacent backbone struts 12 (and
therefore four faces), the inventive device can have three or more
sides, for example with the requisite number of backbone supports.
The cross sectional areas of the expandable support device, can
include triangular shapes, square shapes, rectangular shapes, and
any type of polygon-shaped structure, for example when the
expandable support device 2 is in an expanded configuration. The
longitudinal length of each side of the expandable support device 2
can be equal to the other sides or sides of the expandable support
device 2. The longitudinal length of each side of the expandable
support device 2 can be substantially different than the other
sides or sides of the expandable support device 2.
[0051] Any portion of the expandable support device 2 can have one
or more ingrowth ports (not shown). The ingrowth ports can be
configured to encourage biological tissue ingrowth therethrough
during use. The ingrowth ports can be configured to releasably
and/or fixedly attach to a deployment tool or other tool. The
ingrowth ports can be configured to increase, and/or decrease,
and/or focus pressure against the surrounding biological tissue
during use. The ingrowth ports can be configured to increase and/or
decrease the stiffness of either the backbone or support
struts.
[0052] The expandable support device 2 can have any number of
support struts 10. The support struts 10 can have a substantially
"V"-like shape that deforms or expands as the implant expands, such
as shown in FIG. 2. The shape of the support struts 10 can be
shapes other than the substantially "V"-like shape. The struts 10
can be configured as any shape to accommodate the expansion of the
implant 2. Such shapes can include a substantially "U"-like shape,
a substantially "W"-like configuration, an substantially "S"-like
configuration. The struts can have a combination of configurations
in the same expandable support device 2, for example, to time the
expansion of portions of the implant or otherwise control the
profile of the implant during expansion.
[0053] The expandable support device 2 can have a wall thickness
from about 0.25 mm (0.098 in.) to about 5 mm (0.2 in.), for example
about 1 mm (0.04 in.). The expandable support device 2 can have an
inner diameter (e.g., between farthest opposing backbone
structures). The inner diameter can be from about 1 mm (0.04 in.)
to about 30 mm (1.2 in.), for example about 6 mm (0.2 in.). The
wall thickness and/or the inner diameter can vary with respect to
the length along the longitudinal axis 4. The wall thickness and/or
the inner diameter can vary with respect to the angle formed with a
plane parallel to the longitudinal axis 4. The wall thickness can
be reduced at points where deformation is desired. For example, the
wall thickness of the support struts 10 can be reduced where the
backbone structure meets the end portions.
[0054] FIG. 3 illustrates that the implant 2 can have near and far
end portions 13 and 14. The near and far end portions 13 and 14 can
be attached to each backbone strut via a near and far end of the
backbone strut 12.
[0055] FIG. 4 illustrates a front view of the implant 2 taken along
the line 4-4 of FIG. 3. The end portions of the expandable support
device 2 can have openings 16. The opening 16 can be threaded to
accommodate a threaded member. One or both of the end portions can
be solid which allows for filling of the expandable support device
2 with materials described herein. The end portions can be
expandable. The end portions can be non-expandable (i.e.,
rigid).
[0056] FIG. 5 illustrates that after expansion the backbone struts
18 can remain parallel to the longitudinal axis 4 and the ends of
the backbone struts can form a taper with the near and far end
portions 13 and 14.
[0057] FIG. 6 illustrates a front view taken along the line 6-6 of
FIG. 5 of the expandable support device 2. The expandable support
device 2 can have a square cross sectional shape as the backbone
struts 12 remain parallel to the longitudinal axis 4.
[0058] The expandable support device 2 can have one or more
protrusions on the surface of the expandable support device 2. The
protrusions can have features such as tissue hooks, and/or barbs,
and/or cleats. The protrusions can be integral with and/or fixedly
or removably attached to the expandable support device 2. The
expandable support device 2 can be configured (e.g., on the support
struts 10 or other parts of the implant) to burrow into soft bone
(e.g., cancellous or diseased), for example, until the device fully
expands, or until the device hits the harder vertebral
endplates.
[0059] Any or all elements of the expandable support device 2
and/or other devices or apparatuses described herein (e.g.,
including all deployment tools and their elements described below)
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.), 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 ketone (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.
[0060] Any or all elements of the expandable support device 2
and/or other devices or apparatuses described herein (e.g.,
including all deployment tools and their elements described below),
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.), polypropylene, PTFE, ePTFE, nylon, extruded
collagen, silicone or combinations thereof.
[0061] The expandable support device 2 and/or elements of the
expandable support device 2 and/or other devices or apparatuses
described herein (e.g., including all deployment tools and their
elements described below) 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.
[0062] 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.
[0063] 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.
Method of Use
[0064] FIG. 7 illustrates that the expandable support device 2 can
be loaded in a collapsed (i.e., contracted) configuration onto a
deployment tool 38. The deployment tool 38 can have an expandable
balloon catheter as known to those having an ordinary level of
skill in the art. The deployment tool 38 can have a catheter 40.
The catheter 40 can have a fluid conduit 42. The fluid conduit 42
can be in fluid communication with a balloon 44. The balloon 44 and
the deployment tool 38 can be the balloon 44 and deployment tool 38
as described by PCT Application No. US2005/033965 filed 21 Sep.
2005, which is herein incorporated by reference in its entirety.
The balloon 44 can be configured to receive a fluid pressure of at
least about 5,000 kPa (50 atm), more narrowly at least about 10,000
kPa (100 atm), for example at least about 14,000 kPa (140 atm).
[0065] The expandable support device 2 can be deployed and/or
expanded with a force from a mechanical actuation device (e.g., as
opposed to the balloon expansion). For example, the ends of the
expandable support device 2 can move, or be moved, together to
expand the backbone struts outward. The expandable support device 2
can be configured to be self-expand upon the removal of a restraint
(e.g., when the expandable support device 2 is constructed from a
resilient or super-elastic material). The expandable support device
2 can be made from a shape memory alloy that can have a
pre-determined transition temperature such that expansion takes
place due to temperature changes passively (e.g., from the
patient's body heat) or actively (e.g., from thermal and/or
electrical energy delivered to the expandable support device 2 from
outside the patient) created during or after implantation.
[0066] The expandable support device 2 can be locked into the
expanded configured with a locking structure (e.g., a center strut,
ratchet type mechanism, screw, locking arm, combinations thereof)
that can be integral with or separate from the remainder of the
expandable support device 2. The expandable support device 2 can be
"locked" into the expanded position by filing the expandable
support device 2 with cement, filler (bone chips, calcium sulfate,
coralline hydroxyapatite, Biocoral, tricalcium phosphate, calcium
phosphate, PMMA, bone morphogenic proteins, other materials
described herein, or combinations thereof.
[0067] The deployment tool 38 can be a pair of wedges, an
expandable jack, other expansion tools, or combinations thereof
[0068] FIG. 8 illustrates that the fluid pressure in the fluid
conduit 42 and balloon can increase, thereby inflating the balloon
44, as shown by arrows. The expandable support device 2 can expand,
for example, due to pressure from the balloon 44.
[0069] FIGS. 9 (side view) and 10 (top view) illustrates a group of
bones, such as vertebral column 46, that can have one or more
bones, such as vertebra 48, separated from the other vertebra 48 by
soft tissue, such as vertebral discs 50. The vertebra 48 can have a
target or damage site 52, for example a compression fracture.
[0070] An access tool 54 can be used to gain access to the damage
site 52 and or increase the size of the damage site 52 to allow
deployment of the expandable support device 2. The access tool 54
can be a rotating or vibrating drill 56 that can have a handle 58.
The drill 56 can be operating, as shown by arrows 60. The drill 56
can then be translated, as shown by arrow 62, toward and into the
vertebra 48 so as to pass into the damage site 52.
[0071] FIG. 11 illustrates that the access tool 54 can be
translated, as shown by arrow, to remove tissue at the damage site
52. The access tool 54 can create an access port 64 at the surface
of the vertebra 48. The access port 64 can open to the damage site
52. The access tool 54 can then be removed from the vertebra
48.
[0072] FIG. 12 illustrates that a first deployment tool 38a can
enter through the subject's back. The first deployment tool 38a can
enter through a first incision 66a in skin 68 on the posterior side
of the subject near the vertebral column 46. The first deployment
tool 38a can be translated, as shown by arrow 70, to position a
first expandable support device 2a into a first damage site 52a.
The first access port 64a can be on the posterior side of the
vertebra 48.
[0073] A second deployment tool 38b can enter through a second
incision 66b (as shown) in the skin 68 on the posterior or the
first incision 66a. The second deployment tool 38b can be
translated through muscle (not shown), around nerves 72, and
anterior of the vertebral column 46. The second deployment tool 38b
can be steerable. The second deployment tool 38b can be steered, as
shown by arrow 74, to align the distal tip of the second expandable
support device 2b with a second access port 64b on a second damage
site 52b. The second access port 64b can face anteriorly. The
second deployment tool 38b can translate, as shown by arrow 76, to
position the second expandable support device 2 in the second
damage site 52b.
[0074] The vertebra 48 can have multiple damage sites 52 and
expandable support devices 2 deployed therein. The expandable
support devices 2 can be deployed from the anterior, posterior,
either or both lateral, superior, inferior, any angle, or
combinations of the directions thereof.
[0075] FIGS. 13 and 14 illustrate translating, as shown by arrow,
the deployment tool 38 loaded with the expandable support device 2
through the access port 64. FIG. 15 illustrates locating the
expandable support device 2 on the deployment tool 38 in the damage
site 52.
[0076] FIGS. 16 and 17 illustrate that the deployment tool 38 can
be deployed from the posterior side of the vertebral column 46. The
deployment tool 38 can be deployed off-center, for example, when
approaching the posterior side of the vertebral column 46.
[0077] FIGS. 18 and 19 illustrate that first and second deployment
tools 38a and 38b can position and deploy first and second
expandable support devices 2a and 2b simultaneously, and/or in the
same vertebra 48 and into the same or different damage sites 52a
and 52b.
[0078] FIG. 20 illustrates that the fluid pressure in the fluid
conduit 42 and the balloon 44 can increase, thereby inflating the
balloon 44, as shown by arrows. The expandable support device 2 can
expand, for example, due to pressure from the balloon 44. The
balloon 44 can be expanded until the expandable support device 2 is
substantially fixed to the vertebra 48. The balloon 44 and/or the
expandable support device 2 can reshape the vertebral column 46 to
a more natural configuration during expansion of the balloon
44.
[0079] FIG. 21 illustrates that the access port 64 can be made
close to the disc 50, for example when the damage site 52 is close
to the disc 50. The deployment tool 38 can be inserted through the
access port 64 and the expandable support device 2 can be deployed
as described supra.
[0080] FIG. 22, a front view of the vertebral column, illustrates
that more than one expandable support device 2 can be deployed into
a single vertebra 48. For example, a first expandable support
device (not shown) can be inserted through a first access port 64a
and deployed in a first damage site 52a, and a second expandable
support device (not shown) can be inserted through a first access
port 64a and deployed in a second damage site 52b.
[0081] The first access port 64a can be substantially centered with
respect to the first damage site 52a. The first expandable support
device (not shown) can expand, as shown by arrows 78, substantially
equidirectionally, aligned with the center of the first access port
64a. The second access port 64b can be substantially not centered
with respect to the second damage site 52b. The second expandable
support device (not shown) can substantially anchor to a side of
the damage site 52 and/or the surface of the disc 50, and then
expand, as shown by arrows 80, substantially directionally away
from the disc 50.
[0082] FIG. 23 illustrates that the fluid pressure can be released
from the balloon 44, and the balloon 44 can return to a
pre-deployment configuration, leaving the expandable support
element substantially fixed to the vertebra 48 at the damage site
52.
[0083] The access port 64 can have an access port diameter 82. The
access port diameter 82 can be from about 1.5 mm (0.060 in.) to
about 40 mm (2 in.), for example about 8 mm (0.3 in.). The access
port diameter 82 can be a result of the size of the access tool 54.
After the expandable support device 2 is deployed, the damage site
52 can have a deployed diameter 84. The deployed diameter 84 can be
from about 1.5 mm (0.060 in.) to about 120 mm (4.7 in.), for
example about 20 mm (0.8 in.). The deployed diameter 84 can be
greater than, equal to, or less than the access port diameter
82.
[0084] FIG. 24 illustrates that the deployment tool 38 can be
removed, as shown by arrow, from the vertebra 48 after the
expandable support device 2 is deployed.
[0085] FIGS. 25 and 26 illustrate the expandable support device 2
can be placed between the vertebral bodies into a defect 52 of the
vertebral disc. FIG. 25 illustrates an anterior approach to
inserting the expandable support member between vertebral bodies.
FIG. 26 illustrates a posterior approach to inserting the
expandable support member. The expandable support member can also
be inserted from a lateral approach.
[0086] The expandable support device 2 can be configured to create
a cavity or otherwise displaces bone and/or tissue to form a space
within the target sites during deployment (e.g., during radial
expansion). For example, the struts of the expandable support
device 2 can be configured so the radial expansion of the
expandable support device 2 can move and/or compact bone/tissue.
The struts can be configured to be narrow such that, on expansion,
the struts move a relatively smaller amount of bone and/or tissue
such that the struts do not compact the tissue.
[0087] After the expandable support device 2 has been initially
deployed (i.e., inserted, and/or radially expanded) into the
treatment site, the expandable support device 2 can be retracted,
removed, resized, repositioned, and combinations thereof. The
expandable support device 2 can be retracted and/or removed, and/or
resized, and/or repositioned, for example, about 0 to about 2
months after initial deployment and/or the latest removal, and/or
resizing, and/or repositioning.
[0088] FIG. 27 illustrates that the deployment tool 38, such as an
engagement device, can be configured to attach to the implanted
expandable support device. The engagement device can have one or
more engagement elements 100, such as first and second engagement
elements 100a and 100b. The engagement elements 100 can be on the
radial inside and/or radial outside of the engagement device. For
example, the engagement elements can be on an inner rod 102 that
can be translatably and/or rotationally slidably attached to an
outer handle 104. The engagement elements 100 can be a screw
thread, a keyed slot, a toggle, ball and socket, an interference
fit, a clip, a ratchet, a magnet, glue, an expanding anchor clip,
an abutment, a hook, or combinations thereof. The engagement device
can be the deployment device (e.g., the deployment tool or other
device originally used to deploy the expandable support device
2).
[0089] FIG. 27 illustrates that the engagement device 38 can attach
to the expandable support device 2. The expandable support device 2
can be configured to releasably attach to the engagement elements
100 at discrete locations (e.g., along discrete lengths of the
inner diameter of the expandable support device 2).
[0090] The first engagement element 100a can attach to the proximal
end of the expandable support device 2. The first engagement
element 100a can be an abutment. The second engagement element 100b
can attach to the distal end of the expandable support device 2.
The second engagement element 100b can be a threaded outer surface.
The expandable support device 2 can have a threaded inner radius,
for example, that can be configured to engage the threaded outer
surface of the second engagement element 100b.
[0091] FIG. 28 illustrates that a tensile force, as shown by arrows
106, can be applied to the ends of the expandable support device 2,
for example, via the engagement device 38 and the first and second
engagement elements 100a and 100b. For example, the inner rod 102
can be pushed distally while the outer handle 104 can be
concurrently pulled proximally. The radius of the expandable
support device 2 can contract, as shown by arrows 108.
[0092] FIG. 29 illustrates that the tensile force, shown by arrows
106, can longitudinally expand the expandable support device. The
expandable support device can radially contract, for example, until
the expandable support device 2 is in a configuration completely or
substantially equivalent to the configuration of the expandable
support device 2 before the original deployment of the expandable
support device to the treatment site. For example, the expandable
support device 2 can have a maximum outer radius that is equal to
or smaller than the inner radius of the portion (e.g., the outer
handle 104) of the deployment tool 38 into which the expandable
support device 2 can be configured to retract.
[0093] The expandable support device 2 can be withdrawn from the
target site, and/or retracted into the engagement device 38.
[0094] FIG. 30 illustrates that the outer handle 104 can be a
sheath and/or a sheath can be radially outside or inside of the
outer handle 104. The sheath can have a sheath entry 110. The
sheath entry 110 can be at the distal end of the sheath. The sheath
entry 110 can have a hard material edge, and/or a slippery polymer
edge, and/or a tapered edge, and/or an expanding slotted tube front
edge, and/or a sacrificial (e.g., breakaway) edge.
[0095] FIG. 31 illustrates that the sheath can be forced over the
expandable support device 2, and/or the expandable support device 2
can be drawn, as shown by arrow 112, into the sheath.
[0096] FIG. 31 illustrates that the expandable support device 2 can
radially contract, as shown by arrows 114, as the expandable
support device 2 is completely or partially translated (e.g.,
withdrawn, retracted), as shown by arrow 112, into the sheath. The
radial contraction of the expandable support device 2 can be
resilient or forced deformation.
[0097] FIG. 32 illustrates that the expandable support device 2 can
be completely withdrawn or retracted into the sheath. In a radially
contracted configuration, the outer radius of the expandable
support device 2 can be about equal to and/or smaller than the
inner radius of the sheath. The deployment tool 38 and expandable
support device 2 can be removed from the target site.
[0098] FIG. 33 illustrates a side view of the engagement device 38
deployed through the expandable support device 2. The engagement
device 38 can be deployed extending through the expandable support
device 2, for example through a center channel or port.
[0099] FIG. 34 illustrates that the engagement device 38 can have
an engagement element 100 that can be configured to unbuckle, tear,
split, destroy, separate, cut, break or combinations thereof, the
struts 10. The engagement element 100 can be a cutter saw 116,
and/or otherwise have a bladed or sharp proximal side.
[0100] FIG. 35 illustrates that the engagement device 38 can be
longitudinally translated, as shown by arrow, for example, drawing
the engagement element 100 through the struts 10. The engagement
element 100 can unbuckle, tear, split, destroy, separate, cut,
break or combinations thereof, the struts 10. The engagement
element 100 can partially or completely collapse or buckle the
expandable support device 2, for example within the target or
treatment site (e.g., bone cavity).
[0101] FIGS. 36a and 36b illustrate that the expandable support
device 2 can be separated into two or more expandable support
device pieces 118. The expandable support device pieces 118 can be
removed and/or repositioned and/or resized individually and/or
together from the target site.
[0102] FIG. 37 illustrates a cross-sectional view of a method of
adjusting the expandable support device similar to the method
illustrated in FIGS. 27 through 29. The first engagement element
100a can be threading on the radial inside of the outer handle. The
first engagement element 100a can be forced toward the second
engagement element 100b (e.g., by pushing the outer handle 104
distally and pulling the inner rod 102 proximally), for example to
radially expand and longitudinally contract the expandable support
device 2. The first engagement element 100a can be forced away from
the second engagement element 100b (e.g., by pulling the outer
handle 104 proximally and pushing the inner rod 102 distally), for
example to radially contract and longitudinally expand the
expandable support device 2
[0103] The deployment tool 38 can be rotatably attached to and
detached from the expandable support device 2. The outer handle 104
can contact the expandable support device 2 by completely
encircling the first engagement element 100a, and/or by discretely
contacting the first engagement element 100a, for example with a
set of individual radially translatable arms that can be detached
from the first engagement element 100a by translating the arms
radially outward (or inward if necessary) from the first engagement
element 100a.
[0104] The outer handle 104 and inner rod 102 can be detached
and/or reattached in any combination to the expandable support
device 2. For example, the expandable support device 2 can be
positioned in the target site. The expandable support device 2 can
then be radially expanded (e.g., by applying a longitudinally
compressive force). The inner rod 102 can then be detached from the
expandable support device 2. The expandable support device 2 can be
repositioned by manipulating the expandable support device 2 with
the outer handle 104. The outer handle 104 can then be detached
from the expandable support device 2 and the deployment tool can be
withdrawn from the target site and/or the inner rod 102 can be
reattached to the expandable support device 2 and the expandable
support device can be radially expanded, and/or radially
contracted, and/or repositioned within the target site, and/or
removed from the target site.
[0105] FIG. 38 illustrates a cross section of the expandable
support device 2 implanted at a treatment site 52 in a bone 48. The
expandable support device 2 can have one or more markers, such as a
first marker 120a and/or a second marker 120b, attach to and/or be
integral with the expandable support device 2. Any number of
markers 120 can extend out of the bone 52. The markers 120 can be
radiopaque and/or echogenic. The markers 120 can be used, for
example, to locate the expandable support device 2 (e.g., once the
bone 48 has regrown around the treatment site 52).
[0106] The expandable support device 2 can be configured to
radially contract when a rotational (e.g., twisting) force is
applied to the expandable support device 2. The expandable support
device 2 can have a completely or partially coiled or otherwise
spiral configuration. The expandable support device 2 can have a
radius or height reduction based on a twisting effect.
[0107] The expandable support device 2 can be configured to be
overdeployable. When the expandable support device 2 is
overdeployed, the expandable support device 2 can return to a
substantially pre-deployment configuration (e.g., having a
pre-deployment radius, but in a different configuration
otherwise).
[0108] FIGS. 39 through 41 illustrate that the configuration of the
struts 10 can cause the expandable support device 2 to have an
overdeployment radius substantially equivalent to a pre-deployment
radius 122. FIG. 39 illustrates the expandable support device 2 in
a pre-deployment configuration. A longitudinally compressive force,
as shown by arrows 124, can be applied. Radial expansion, as shown
by arrows 126, can begin, for example due to the longitudinally
compressive force.
[0109] FIG. 40 illustrates that when the expandable support device
2 is fully deployed, the expandable support device 2 has no radial
expansion. The longitudinally compressive forces, as shown by
arrows 124, can begin to force the struts longitudinally inward,
for example beyond a configuration at the maximum radial expansion
of the expandable support device 2. This overdeployment can cause a
decrease in the radius of the expandable support device 2.
[0110] FIG. 41 illustrates that when the expandable support device
2 is overdeployed, the expandable support device 2 can radially
contract, as shown by arrows 128. The expandable support device 2
can have an overdeployment radius 130 substantially equivalent to,
or less than, or greater than the pre-deployment radius 122.
[0111] FIG. 42 illustrates that the expandable support device 2 can
have a control element, such as internal control shaft 132. The
internal control shaft 132 can be removably attached to the inner
rod 102. The remainder of the expandable support element 2 can be
removably and/or rotatably attached to the interenal control shaft
132.
[0112] The internal control shaft 132 can have the first and second
engagement elements 100a and 100b. The expandable support element 2
can have discrete first and second receivers 136a and 136b
configured to removably attach to the first and second engagement
elements 100a and 100b, respectively. For example, the first and
second receivers 136a and 136b can be threaded.
[0113] The first engagement element 100a can have a stop or brake
thread 140, for example configured to interference fit the first
receiver 136a.
[0114] In an undeployed or pre-deployed (e.g., radially contracted)
configuration, the second engagement element 100b can be attached
to the second receiver 136b. The first engagement element 100a can
be unattached to the first receiver 136a.
[0115] FIG. 43 illustrates that a compression force, shown by
arrows 142, can be applied to the expandable support device 2. For
example, the sliding rod 102 can be pulled proximally and the
outside handle 104 can be pushed distally. The expandable support
device 2 can be attached to the sliding rod 102 via the second
engagement element 100b and the second receiver 136b. The
expandable support device 2 can be attached to the outside handle
104 via abutting or otherwise engaging at the first receiver 136a
or other element. The compression force can produce radial
expansion, as shown by arrows 144, in the expandable support device
2.
[0116] FIG. 44 illustrates that once the expandable support device
2 is substantially radial expanded, the inner rod can be rotated,
as shown by arrow 146, with respect to the expandable support
device 2 with the exception of the inner control shaft 148. (The
expandable support device can be held rotationally stationary by
the target site and/or by engagement between the outside handle and
the expandable support device 2.) The inner control shaft 132 can
rotate as shown by arrow 148. The rotation of the second engagement
element 100b with respect to the second receiver 136b can force the
control shaft 132 to translate, as shown by arrow 150, with respect
to the expandable support device 2. The expandable support device 2
can radially expand during the translation shown by the arrow
150.
[0117] FIG. 45 illustrates that during the translation shown by
arrow 150 in FIG. 44, the first engagement element 100a can engage
the first receiver 136a. The second engagement element 100b can
remain engaged to the second receiver 136b. The inner rod 102,
control shaft 132, and first engagement element 136a can rotate
with respect to the remainder of the expandable support device 2,
for example until a safety element, such as the brake thread 140,
stops the rotation. The brake thread 140 can interference fit with
the first receiver 136a. The brake thread 140 can provide
sufficient resistance to friction fit with the first receiver 136a.
The safety element (e.g., stop or brake thread) can be on the first
and/or second engagement elements 100a and/or 100b and/or first
and/or second receivers 136a and/or 136b.
[0118] FIG. 46 illustrates that the inner control shaft 132 can be
detached from the inner rod 102, for example at a coupling point
152. The coupling point 152 can include one or more detachable
attachment elements, such as hooks, pegs and holes, thread knots
and holes, radially translatable arms, teeth, threads, or
combinations thereof. The inner control shaft 132 can have
corresponding detachable attachment elements, such as threads 154.
The threads can be in the same direction (e.g., with higher
coefficients of friction) as the threads of the first and second
engagement elements 100a and 100b, or counter-threaded with respect
to the threads of the first and second engagement elements 100a and
100b. The coupling point 152 can be detached by deactivating or
otherwise detaching the detachable attachment elements. For
example, the inner rod 102 can be rotated or counter rotated as
necessary, as shown by arrow. The inner control shaft 132 can
remain rotationally fixed because, for example, the target site has
substantially fixed the expandable support device and the brake
thread 140 can fix the inner control shaft 132 to the expandable
support device 2.
[0119] The deployment tool 38 can be removed from the target site.
The expandable support device 2 can remain in the target site, for
example, fixed in the deployed configuration (e.g., unable to
substantially radially or longitudinally expand or contract) and/or
bolstered by the inner control shaft 132. The deployment tool 38
can re-engage the expandable support device 2 and the above steps
can be reversed to radially contract and retract, reposition,
and/or remove the expandable support device 2 in or from the target
site.
[0120] The expandable support device 2 can have a mechanical key or
locking bar that can fix the expandable support device 2 in an
expanded or otherwise deployed configuration. When the key or
locking bar is removed from the expandable support device 2, the
expandable support device 2 can be repositioned, and/or removed
and/or resized (e.g., deconstructed), for example, automatically,
resiliently radially compressed.
[0121] The expandable support device can be subject to fatigue, for
example, to increase material brittleness resulting in fracture.
The fractured pieces of the expandable support device can be
removed, for example, by suction and irrigation. The engagement
element can be a small grabber or gripper. The engagement element
can induce oscillating motion in the struts. The oscillating motion
can cause strut fatigue and failure, for example in the struts
and/or in the joints. The oscillating motion can be ultrasonic,
mechanical, hydraulic, pneumatic, or combinations thereof.
[0122] The expandable support device 2 can have receiving elements
to engage the engagement elements. For example, the receiving
elements can be hooks, barbs, threads, flanges, wedge shaped slots,
dovetails, hinges, key holes, or combinations thereof.
[0123] The expandable support device 2 can have a leader. The
leader can be a heavy wire. The leader can guide the engagement
device into and/or over the implant. The engagement device 38 can
radially contract the implant, for example, using a method
described herein. The engagement device 38 and/or another tool can
drill or otherwise destroy bone and/or other tissue to access the
expandable support device 2.
[0124] The tissue surrounding the expandable support device 2 can
be destroyed (e.g., chemically and/or electrically and/or
thermally, such as by cauterization or electro-cauterization). The
expandable support device 2 can be removed and/or repositioned
and/or resized once the surrounding tissue is completely or
substantially destroyed.
[0125] The expandable support device 2 can be mechanically
destroyed. For example, the expandable support device can be
mechanically compressed, for example by applying external radially
and/or axially (i.e., longitudinally) contracting jaws. A snipper
and/or microgrinder and/or saw can mechanically destroy the
expandable support device.
[0126] The expandable support device 2 can be chemically destroyed
using RF energy. For example UV energy can be delivered to dissolve
a plastic expandable support device.
[0127] The expandable support device 2 can be biodegradable. The
expandable support device 2 can be made from biodegradable
materials known to those having ordinary skill in the art. The
expandable support device 2 can be made from a magnesium based
alloy that can degrade or a biodegrading polymer for example, PGA,
PLA, PLLA, PCL.
[0128] The expandable support device 2 can be configured to device
designed to dissolve when exposed to selected materials (e.g., in
solution). For example, acetone can be applied to the expandable
support device (e.g., made from PMMA). The surrounding tissues can
be protected and/or the expandable support device can be fluidly
contained before the dissolving solution is applied.
[0129] The expandable support device 2 can be dissolved, for
example, by exposing the expandable support device to an
electrolyte and electricity.
[0130] Imaging methods can be used in combination with the methods
for deploying the expandable support device described herein. For
example, imaging methods can be used to guide the expandable
support device during deployment. The expandable support device 2
can have imaging markers (e.g., echogenic, radiopaque), for example
to signal the three-dimensinal orientation and location of the
expandable support device during use of an imaging modality.
Imaging modalities include ultrasound, magnetic resonance imaging
(MRI, fMRI), computer tomography (CT scans) and computed axial
tomography (CAT scans), radiographs (x-rays), fluoroscopy, diffuse
optical tomography, elastography, electrical impedance tomography,
optoacoustic imaging, positron emission tomography, and
combinations thereof.
[0131] It is apparent to one skilled in the art that various
changes and modifications can be made to this disclosure, and
equivalents employed, without departing from the spirit and scope
of the invention. Elements expressed herein as singular or plural
can be used in the alternative (i.e., singular as plural and plural
as singular). Elements shown with any embodiment are exemplary for
the specific embodiment and can be used in combination on or with
other embodiments within this disclosure.
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