U.S. patent application number 12/483180 was filed with the patent office on 2009-12-17 for formed in place corpectomy device.
Invention is credited to Samuel M. Shaolian, Michael C. Sherman.
Application Number | 20090312806 12/483180 |
Document ID | / |
Family ID | 37110193 |
Filed Date | 2009-12-17 |
United States Patent
Application |
20090312806 |
Kind Code |
A1 |
Sherman; Michael C. ; et
al. |
December 17, 2009 |
Formed in Place Corpectomy Device
Abstract
An inflatable corpectomy device comprises a balloon, which
defines a cavity for receiving a hardenable media. The device can
be inserted in an un-inflated form into a space formerly occupied
by a diseased or damaged vertebrae bone. When inflated with a
hardenable material, the device expands and fills the space.
Various bone anchors or plates can be used in combination with the
inflatable device to bridge the space and stabilize the spine while
the device hardens.
Inventors: |
Sherman; Michael C.;
(Memphis, TN) ; Shaolian; Samuel M.; (Newport
Beach, CA) |
Correspondence
Address: |
Medtronic;Attn: Noreen C. Johnson, IP Legal Department
2600 Sofamor Danek Drive
Memphis
TN
38132
US
|
Family ID: |
37110193 |
Appl. No.: |
12/483180 |
Filed: |
June 11, 2009 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
11145238 |
Jun 3, 2005 |
|
|
|
12483180 |
|
|
|
|
Current U.S.
Class: |
606/86R ;
606/191; 623/17.11 |
Current CPC
Class: |
A61F 2/4611 20130101;
A61F 2002/30583 20130101; A61F 2/441 20130101; A61F 2210/0085
20130101; A61F 2/44 20130101; A61F 2002/4627 20130101 |
Class at
Publication: |
606/86.R ;
623/17.11; 606/191 |
International
Class: |
A61B 17/58 20060101
A61B017/58; A61F 2/44 20060101 A61F002/44; A61M 29/00 20060101
A61M029/00 |
Claims
1-20. (canceled)
21. A kit for use in a minimally invasive corpectomy procedure, the
kit comprising: a bone graft sized for positioning in a space
between a first vertebra and a non-adjacent second vertebra, the
bone graft having outer surface, an opposing inner surface defining
a bore, and an opening extending between the outer surface and the
inner surface; a balloon having a deflated configuration sized for
minimally invasive insertion through the opening and into the bore
of the bone graft while the bone graft is positioned in the space
between the first and second vertebrae and an inflated
configuration sized to fill the bore; a hardenable media configured
to be injected into the balloon while the balloon is positioned
within the bore of the bone graft in order to inflate the balloon
from the deflated configuration to the inflated configuration; and
a deployment catheter configured to insert the balloon into the
bone graft and inject the hardenable media into the balloon.
22. The kit of claim 21, further comprising a stabilizing support
structure sized to extend between the first vertebra and the second
vertebra.
23. The kit of claim 22, further comprising a plurality of bone
engaging components for anchoring the stabilizing support structure
to the first and second vertebrae.
24. The kit of claim 21, wherein the hardenable media has a modulus
of elasticity between about 10-200 GPa after hardening.
25. The kit of claim 21, wherein the balloon has a height between
about 20-40 millimeters in the inflated configuration.
26. The kit of claim 25, wherein the balloon has a length between
about 20-40 millimeters in the inflated configuration.
27. The kit of claim 21, wherein the balloon comprises a
self-sealing valve for receiving the hardenable media.
28. The kit of claim 21, wherein the balloon comprises a
reinforcement element.
29. The kit of claim 28, wherein the reinforcement element
comprises a resistive heating element.
30. The kit of claim 21, wherein the balloon comprises a heating
element.
31. The kit of claim 30, wherein the balloon and heating element
are configured to heat the hardenable media received within the
balloon to a temperature of at least about 50.degree. C. while
maintaining an outer surface of the balloon at a temperature less
than about 45.degree. C.
32. A corpectomy prosthesis system, comprising: a bone graft sized
for positioning in a space between a first vertebra and a
non-adjacent second vertebra, the bone graft having outer surface,
an opposing inner surface defining a bore, and an opening extending
between the outer surface and the inner surface; a balloon having a
deflated configuration sized for minimally invasive insertion
through the opening and into the bore of the bone graft while the
bone graft is positioned in the space between the first and second
vertebrae and an inflated configuration sized to fill the bore; and
a hardenable media configured to be injected into the balloon while
the balloon is positioned within the bore of the bone graft in
order to inflate the balloon from the deflated configuration to the
inflated configuration.
33. The corpectomy prosthesis system of claim 32, further
comprising a stabilizing support structure sized to extend between
the first vertebra and the second vertebra.
34. The corpectomy prosthesis system of claim 33, further
comprising a plurality of bone engaging components for anchoring
the stabilizing support structure to the first and second
vertebrae.
35. The corpectomy prosthesis system of claim 32, wherein the
balloon has a height between about 20-40 millimeters in the
inflated configuration.
36. The corpectomy prosthesis system of claim 32, wherein the
balloon comprises a reinforcement element.
37. The corpectomy prosthesis system of claim 36, wherein the
reinforcement element comprises a resistive heating element.
38. The corpectomy prosthesis system of claim 37, wherein the
balloon and resistive heating element are configured to heat the
hardenable media received within the balloon to a temperature of at
least about 50.degree. C. while maintaining an outer surface of the
balloon at a temperature less than about 45.degree. C.
39. A kit for use in a minimally invasive corpectomy procedure, the
kit comprising: a balloon sized for positioning in a space between
a first vertebra and a non-adjacent second vertebra, the balloon
having a deflated configuration sized for minimally invasive
insertion into the space between the first and second vertebrae and
an inflated configuration sized to fill the space between the first
and second vertebrae; a hardenable media configured to be injected
into the balloon while the balloon is positioned within the space
between the first and second vertebrae in order to inflate the
balloon from the deflated configuration to the inflated
configuration; and a deployment catheter configured to minimally
invasively insert the balloon into the space and inject the
hardenable media into the balloon to inflate the balloon from the
deflated configuration to the inflated configuration.
40. The kit of claim 39, further comprising a heating element
disposed within the balloon for heating the hardenable media to a
temperature of at least about 50.degree. C.; and wherein the
balloon is formed of a material that provides insulation to
surrounding tissue such that an outer surface of the balloon is
maintained at a temperature less than about 45.degree. C. when the
hardenable media is heated to the temperature of at least about
50.degree. C.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] The present invention relates to medical devices and
techniques and, more particularly, to systems and methods for
treating injuries, deformities or diseases of the spine.
[0003] 2. Description of the Related Art
[0004] Corpectomy is a well-known procedure that is performed to
relive the pain caused by a diseased (e.g., with a tumor) or
damaged (e.g., fractured) vertebrae bone that blocks and pinches
the spinal cord. It can also be used as part of a strategy to
correct spinal column deformities.
[0005] Often, corpectomies involve making an incision into the
patient to expose the diseased or damaged portion of the vertebrae
bone. The diseased or damaged parts of the vertebrae bone are then
removed to relieve pressure from the spinal cord. The disc levels
below and above the removed vertebrae bone along with any diseased
fragments are also removed. The bone surfaces are then cleared and
prepared to receive a bone graft or a corpectomy device (see e.g.,
U.S. Pat. No. 6,866,682). Fixation devices (e.g., screws) are
inserted into the vertebrae below and above the gap. The fixation
devices are used to decompress the vertebrae space and/or correct
the spinal column curvature. The surgeon then inserts the bone
graft into the gap, closing the space between the upper and lower
vertebrae bones. A plate (e.g., a "Z-plate") bridges the gap filled
by the graft and is coupled to the fixation devices in the upper
and lower vertebrae bones. The plate secures the area while the
upper and lower vertebrae bones fuse to the bone graft to create
one solid bone segment.
[0006] While corpectomy is a proven procedure used to address
certain spinal diseases, injuries and defects; it does suffer from
several drawbacks. For example, it is associated with morbidity,
high costs, lengthy in-patient hospital stays and the pain
associated with open surgical procedures. Therefore, there is a
need for devices and methods for performing a corpectomy, which
cause less pain and potential complications. Preferably, the
devices and methods utilize minimally invasive procedures.
SUMMARY OF THE INVENTION
[0007] There is provided in accordance with one embodiment of the
present invention a method of treating the spine that includes
removing a damaged or diseased portion of the spine to create a
space at a treatment site. An inflatable balloon is positioned into
the space. A curable media is injected into the balloon, which
expands to at least partially fill the space. The curable media is
allowed to cure within the body.
[0008] Another embodiment of the present invention comprises a
corpectomy prosthesis that includes a balloon having an inflated
shape configured to fill a gap between a first vertebrae bone and a
second non-adjacent vertebrae bone that is created during a
corpectomy procedure. The prosthesis also includes a hardenable
media that is positioned within the balloon and is configured to
harden while the balloon is positioned within the body of a
patient.
[0009] Another embodiment of the present invention comprises a kit
for use in a corpectomy procedure. The kit includes a balloon
having an inflated shape configured to fill a gap in a vertebral
column created by the corpectomy procedure. A hardenable media for
injecting within the balloon. The media is configured to harden
while the balloon is positioned within the gap. The kit also
includes a deployment catheter configured to deliver the balloon
and hardenable media to the gap.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1 is a side elevation view of an exemplary embodiment
of an inflatable corpectomy device.
[0011] FIG. 2 is a cross-sectional view taken through line 2-2 of
FIG. 1.
[0012] FIG. 3 is a cross-sectional view taken through a bone graft
and a modified embodiment of an inflatable corpectomy device.
[0013] FIG. 4 is a side view of an exemplary embodiment of a
delivery catheter having an inflatable corpectomy device
thereon.
[0014] FIG. 4A is a side elevational cross section of a distal
portion of the delivery catheter of FIG. 4.
[0015] FIG. 4B is an enlarged view of the portion labeled 4B-4B in
FIG. 4A.
[0016] FIG. 5 is a cross-sectional view taken through line 5-5 of
FIG. 4.
[0017] FIG. 6 is an enlarged view of the proximal portion of the
delivery catheter shown in FIG. 4.
[0018] FIG. 7 is a side view of the inflatable corpectomy device of
FIG. 4.
[0019] FIG. 8 is a cross-sectional view through of the device of
FIG. 7 with the device in an expanded condition.
[0020] FIG. 9A is a schematic cross-sectional view of a valve of
the inflatable device of FIG. 7.
[0021] FIG. 9B is a schematic cross-sectional view of another
embodiment of a valve.
[0022] FIG. 9C is an end view of the valve of FIG. 9B.
[0023] FIG. 10 is a schematic side elevational view of the distal
end of a deployment catheter having a heated implant removably
positioned thereon.
[0024] FIG. 11 is a schematic side elevational view an implant with
a modified heating element.
[0025] FIG. 12 is a cross-sectional side view of the distal end of
a modified embodiment of a deployment catheter having an implant
thereon.
[0026] FIGS. 13-18 are partial cross-sectional midline sagittal
views of a portion of a vertebral column showing an implantation
method according to an embodiment of the present invention.
[0027] FIG. 19 is a side elevational view of a bone screw or
bolt.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0028] Although the application of the present invention will be
disclosed primarily in connection with a specific spinal fixation
procedure (i.e., corpectomy), the methods and devices disclosed
herein are intended for use in any of a wide variety of medical
applications where formation of an attachment, bulking, support,
fixation or other element in situ may be desirable.
[0029] One advantage of the in situ prosthesis formation described
herein is the ability to obtain access to a treatment site through
a minimally invasive access pathway, while enabling the formation
of a relatively larger implant at the treatment site. This allows
procedure morbidity to be minimized, since open surgical cutdowns
or other invasive access procedures may be avoided or minimized. In
addition, the in situ formation in accordance with the certain
embodiments described herein allows the formation of a corpectomy
device having any of a wide variety of customized or predetermined
shapes, due to the ability of the infusible hardenable media to
assume the shape of the cavity or flexible container into which it
is infused.
[0030] The methods and devices of certain embodiments described
herein additionally enable access to a treatment site within the
body along a curved and even tortuous pathway, through which a
preformed prosthesis would not fit or would not be navigable. The
inflatable corpectomy prosthesis of certain embodiments can be
removably coupled to the distal end of an elongate flexible tubular
catheter body, which can be dimensioned for percutaneous, surgical
or transluminal advancement and deployment of an inflatable or
otherwise curable in place prosthesis in any of a wide variety of
orthopedic applications, such as the spine as disclosed in greater
detail below, as well as long bones, short bones, and associated
ligaments and tendons. In addition, the deployment catheter and
prosthesis can be dimensioned for transluminal navigation
throughout the cardiovascular system, the gastrointestinal tract,
the biliary tract, the genitourinary tract, or the respiratory
tract (e.g. the tracheobronchial tree). The device may thus be
advanced through artificial access pathways as well as naturally
occurring lumens and hollow organs. Additional applications of the
in situ device formation technology disclosed herein will become
apparent to those of skill in the art in view of the disclosure
herein.
[0031] In connection with corpectomies, certain embodiments involve
the partial or total removal of a diseased or damaged vertebrae
bone. An implantable, inflatable orthopedic device is inserted
using an anterior, posterior or lateral approach and inflated into
the space formerly occupied by the removed vertebral bone or
removed portions of bone. The inflatable orthopedic device can be
inserted using open, minimally open or percutaneous techniques. In
one embodiment, the device is inserted into the space using a
transpedicle approach in which a deployment catheter is advanced
through a pedicle of an adjacent vertebrae bone. Various bone
anchors or plates can be used in combination with the inflatable
device to bridge the space and stabilize the spine while the device
or a graft fuses with the adjacent vertebrae bones. In a preferred
embodiment, a deployment system, comprising a delivery catheter
removably carrying the implantable device, is provided, such that
at least portions of the procedure may be conducted in a
percutaneous or minimally invasive manner to minimize procedure
trauma to the patient.
[0032] With reference now to the illustrated embodiment, FIGS. 1
and 2 are side and cross-sectional views of an embodiment of an
implantable orthopedic device 10, which can be used as an
inflatable or formed in place corpectomy device. As will be
explained below, the implantable device 10 can be removably carried
by the distal end of a deployment catheter. The inflatable device
10 can also be used with a bone graft as will be explained below
with reference to FIG. 3.
[0033] The implantable device 10 comprises a shell or balloon 14,
which is shown in an inflated position in FIGS. 1 and 2. The
balloon includes a proximal end 16, a distal end 18, and a flexible
wall 20, which defines a cavity 12. Between the proximal and distal
ends 16, 18, the balloon 14 has sides 17a, 17b, which, in the
illustrated embodiment, form the upper and lower ends 17a, 17b of
the device 10 when it is implanted into the patient as described
below.
[0034] The balloon 14 may be formed from any of a variety of
polymeric materials that are known in the balloon angioplasty arts.
These include, for example, complaint materials such as
polyethylene, polyethylene blends or nylon, and substantially
noncompliant materials such as polyethylene terephthalate. Any of a
wide variety of other biocompatible polymers may be utilized, as
will be apparent to those of skill in the art in view of the
disclosure herein.
[0035] The balloon 14 may comprise a single or multiple layers,
depending upon the desired physical properties. In one embodiment,
the balloon 14 comprises two layers, having a reinforcing structure
such as a stent or a plurality of axially extending support strips
sandwiched therebetween. In an alternate embodiment, the balloon 14
comprises a first, inner layer which restrains the hardenable
media. A second, outer layer is coaxially disposed about the first
layer, and is provided with a plurality of apertures or a
microporous structure. An infusion lumen is provided in the
delivery device for providing communication between a proximal
infusion port and the space in between the inner and outer balloon
layers. In this manner, fluids, which may contain any of a variety
of medications or agents (e.g., orthobiologics and/or bone matrix
material), can be infused into the tissue surrounding the treatment
site. Suitable structures and manufacturing considerations are
disclosed in U.S. Pat. No. 5,295,962 to Crocker et al., the
disclosure of which is incorporated in its entirety herein by
reference.
[0036] Although a generally cylindrical or disk-like configuration
for the balloon 14 is illustrated herein, any of a variety of
alternative cross sectional configurations may be utilized. The
overall length, diameter and wall thickness of the implantable
inflatable orthopedic device 10 can be varied, depending on the
particular treatment and access site. In one embodiment, device 10
has an inflated diameter (d) or height between about 20 mm and
about 30 mm and for positioning between two adjacent vertebrae. The
device 10 has an inflated length (l) of generally between about 20
mm and 40 mm.
[0037] The diameter (d) or height of the balloon 14 is based upon
the anticipated distance between the upper and lower vertebrae
bones that define the boundaries of the space created by the
corpectomy, or, in an embodiment in which only a portion of a
vertebral body is replaced, the anticipated size of the space to be
occupied by the device 10. For example, in an application a lumbar
vertebrae is replaced (e.g. L4), the space between the upper and
lower vertebrae will have distance within the range of from about
10 mm to about 15 mm. Preferably, the diameter of the balloon 14 is
sufficiently large enough to occupy this space.
[0038] In other embodiments, the device 10 is configured to occupy
the space of two or more adjacent replaced vertebrae. In such an
embodiment, a device 10 configured to replace two vertebrae has an
inflated diameter (d) or height between about 20 mm and about 40
mm, for positioning between two adjacent vertebrae. The device 10
has an inflated length (l) of generally between about 20 mm and
about 40 mm.
[0039] It should be appreciated that the diameter (d) and length
(l) of the device 10 described above are made with reference to an
embodiment in which a deployment system is connected to the
proximal end 14 of the device 10. However, it should be appreciated
that this configuration represents just one exemplary embodiment of
the device 10. It is anticipated that in modified embodiments the
proximal and distal ends 16, 18 can correspond to the upper and
lower ends 17a, 17b, when the device 10 is positioned within the
patient. In other embodiments, the connection between the device 10
and the deployment system can be made at an angle with respect to a
longitudinal axis of the spine.
[0040] The primary function of the balloon 14 is to influence or
control the shape of a hardenable media injected therein. The
implantable balloon 14 is not normally required to restrain
pressure over an extended period of time. Thus, greater design
flexibility may be permitted, compared to conventional angioplasty
or other dilatation balloons. For example, the balloon 14 may be
porous, either for drug delivery as has been discussed, or to
permit osteoincorporation and/or soft tissue ingrowth.
[0041] Certain hardenable media which may be utilized in connection
with the embodiments described herein, such as PMMA, have a
significantly greater viscosity in the precured form, compared to
conventional angioplasty balloon inflation media. In addition,
since the balloon 14 is not intended to contain significant
pressure, conventional high strength materials such as for high
pressure angioplasty may not be necessary. This allows the balloon
14 to be constructed in any of a variety of ways, including
techniques utilized for balloon angioplasty applications. In
addition, the balloon 14 (or balloon-like structure) may be made
out of any of a wide variety of woven or nonwoven fibers, fabrics,
metal mesh such as woven or braided wires, and carbon.
Biocompatible fabrics or sheet material such as ePTFE and
Dacron.RTM. may also be used.
[0042] The hardenable media is preferably a rapid setting, liquid
polymer or polymer precursor, such as polymethyl methacrylate
(PMMA). However, any of a variety of other materials which provide
the required stiffening or setting characteristics may be used,
including any of a variety of epoxies, polyurethane, polyester or
blends of polyurethane-silicone. Additional descriptions and
embodiments of such materials can be found in U.S. Pat. No.
6,875,212, the entire contents of which are hereby incorporated by
reference herein.
[0043] In the context of a rod or disc-shaped inflatable container,
for use in the spinal fixation procedures described herein, the
physical requirements of the hardenable media will depend upon the
length and diameter of the rod as well as the physical requirements
imposed by the implantation site. For certain embodiments,
polymethyl methacrylate, epoxy, polyurethane or other particular
material may or may not exhibit sufficient physical properties.
Physical properties of hardenable materials can be modified through
the addition of any of a variety of additives, such as carbon
fibers, Kevlar or Titanium Rods, woven or laser etched metallic
tubular stents, or other strength enhancers as will be understood
in the art. The selection of a particular hardenable media, as well
as the desirability of adding strength, flexibility, or other
physical property enhancers, can be optimized for any particular
implantation system through routine experimentation by those of
skill in the art in view of the disclosure herein.
[0044] Certain composite materials, such as carbon fibers embedded
in a bonding agent such as a two part epoxy, or two part
polyurethane have been found particularly useful in forming the
implant of the present invention. For example, graphite (carbon
fibers) having a diameter within the range of from about 0.003 to
about 0.007 inches are provided in bundles (tows) composed of from
about 3,000 to about 12,000 fibers. One typical fiber useful for
this purpose is manufactured by Hexcel Carbon Fibers, Salt Lake
City, Utah, Part No. HS/CP-5000/IM7-GP 12K. Preferably, the Tow
tensile strength is in the range of from about 5,000 to about 7,000
Mpa. Tow tensile modulus is within the range of from about 250 to
about 350 Gpa.
[0045] In general, the composite rods in accordance with embodiment
described herein will exhibit a static compression bending values
(per ASTM F1717) within the range of from about 100 to about 200
lbs., and, preferably greater than about 150 lbs. The composite
rods will exhibit a static torsion (per ASTM F1717) within the
range of from about 300 to about 500 inch pounds, and, generally in
excess of about 400 inch pounds. The rods will preferably reach at
least about 5 million cycles, at 5 Hz. Each of these parameters may
be measured in accordance with the protocols described in the
American Society for Testing and Materials (ASTM) designation F
1717-96.
[0046] Within the range of from about 30 to about 60 bundles of the
carbon fiber described above is packed in a deflated balloon,
optionally along with a Ni--Ti stent having an appropriate diameter
and appropriate length to fit within the deflated balloon. Although
any of a variety of stents may be utilized, one useful structure is
similar to the Smart Stent (Cordis), which helps keep the structure
intact and also adds structural strength to the implanted
structure.
[0047] A one or a two part epoxy having a viscosity in the range of
from about 100 to about 500 cps is then injected into the balloon
under pressure such as by using a pump and pressure within the
range of from about 4 ATM to about 10 ATM or more depending upon
viscosity, balloon strength and other design considerations. The
pump is run for a sufficient duration and under a sufficient
pressure to ensure that the epoxy wets all of the fibers. This may
range from about 10 minutes or more to about an hour, and, in one
application where the pump was run at about 5 ATM pressure,
requires at least about 1 hour. Specific method parameters may be
optimized depending upon the viscosity of the epoxy, infusion
pressure, infusion flow rate, density of the packed carbon fibers,
and other variables as will be apparent to those of skill in the
art in view of the disclosure herein.
[0048] In an alternate embodiment, carbon fibers having within the
range of from about 15 to about 45 degrees of braids are utilized.
The braid may be in the form of a plain weave, and may be obtained,
for example, from Composite Structures Technology (Tehachapi,
Calif.). A 0.5 inch diameter of 45 degrees braided carbon fiber
sleeve is positioned within the center of the balloon. This braided
sleeve conforms dimensionally to the inside diameter of the
balloon. A 0.3 inch diameter braided carbon sleeve (again
45.degree..times.45.degree. plain weave) may also be positioned
concentrically within the balloon, within the outer braided carbon
fiber sleeve. Unidirectional fibers are thereafter introduced
inside of the ID of the inner braided carbon sleeve. Unidirectional
fibers are also introduced into the annular gap between the two
braided sleeves. The volume of the fiber per volume of balloon is
generally within the range of from about 40% to about 55%. After
placement of the foregoing structure within the spine, the epoxy
mix having a viscosity within the range of from about 100 to about
500 cps is injected under 10 atmospheres pressure into the
balloon.
[0049] Although the foregoing composite structure was described
using a carbon fiber example, any of a variety of fibers may be
positioned within the balloon to enhance the physical properties of
the finished product. For example, Kevlar fibers, PEEK, and any of
a variety of alternatives may be used. In general, the fibers will
preferably provide a very high tensile strength and high modulus,
having a low diameter to enhance deliverability of the device.
[0050] The use of braided sleeves will produce higher structural
resistance to sheer stress as a result of torsional loads, plus the
ability to distribute unidirectional fibers in a homogenous manner
within the balloon at all times. This appears to improve the
performance of the implant.
[0051] Any of a variety of alternate constructions can be readily
utilized, in accordance with the teachings herein. For example,
three or more tubular support tubes may be utilized. The layering
sequence of the various components may be changed, and other
features added or deleted depending upon the desired performance of
the finished device. In addition, although the balloon 14 in one
embodiment comprises a nylon single layer balloon, other materials
may be utilized. In addition, multiple layer balloons may be
utilized, with or without support structures such as stents, wires,
or woven tubular support structures sandwiched therebetween.
[0052] In certain embodiments, it is desirable that the cured
device 10 exhibit a particular modulus of elasticity. Such an
embodiment advantageously provides for limited a degree of motion
(e.g., side-side movement, compression, extension, and/or torsion),
when the device is positioned within the patient. In this manner,
at least some degree of the natural motion of the spine can be
preserved after the device 10 fuses with the remaining portions of
the spine. In one embodiment, the cured device 10 has a modulus of
elasticity between about 10 to about 200 GPa.
[0053] Marker bands made of materials such as gold, platinum or
tantalum may also be positioned on the balloon, to facilitate
fluoroscopic visualization. Alternatively, a radio opaque material,
such as tantalum powder, may be sprinkled among the carbon fibers
prior to infusion of the epoxy or other hardenable media, to allow
visualization during placement.
[0054] The epoxy or the polyurethane material preferably has a
relatively fast cure rate at 37.degree. C. A low viscosity (no
greater than from about 100 to about 1000 CPS) facilitates rapid
transluminal introduction through the delivery catheter and wetting
of the relatively small interstitial spaces between adjacent carbon
fibers. In addition, the polymer is preferably radiopaque. The
polymerization is preferably minimally exothermic, to minimize or
prevent thermal damage to the surrounding tissue. One epoxy which
may be useful in the present invention is Epotek 301 available from
Epoxy Technologies. This epoxy reaches 50 to 60% of its strength
within about three to four hours following deployment, at
37.degree. C. Using a bonding agent having these approximate
characteristics, the patient can be restrained from rolling for an
initial cure period of approximately three or four hours to achieve
a partial cure (e.g., at least about 50% and preferably 60% or
more), and be maintained in bed for a secondary cure period such as
approximately the next eight to twelve hours or more to accommodate
a full cure. Other formulations of two part epoxies or
polyurethanes with faster cure times (preferably no more than about
one hour full cure) can be formulated by changing the ratios of
components and formulations for the catalysts. Cure time can also
be accelerated through the use of accelerators, such as catalysts
or the application of heat or other energy source as is discussed
in detail below.
[0055] Terms such as "hardenable" or "curable" media are used
interchangeably herein, and are intended to include any material
which can be transluminally introduced through the catheter body
into the cavity 12 while in a first, flowable form, and
transitionable into a second, hardened form. These terms are
intended to cover materials regardless of the mechanism of
hardening. As will be understood by those of skill in the art, a
variety of hardening mechanisms may exist, depending upon media
selection, including UV, other wavelength of electromagnetic
energy, or catalyst initiated polymerization, thermally initiated
polymerization, solvent volatilization, and the like. While the
media selection may affect catheter design in manners well
understood by those of skill in the art, such as to accommodate
outgasing of byproducts, application of heat, catalysts, or other
initiating or accelerating influences, these variations do not
depart from the concept of the invention of introducing a flowable
media into a shape and subsequently curing the media to the shape.
Two part medias, such as a two part epoxy or polyurethane, or a
monomer and an initiator may be introduced into the cavity 12
through separate lumen extending throughout the tubular body.
Expandable media may also be provided, such as a material which is
implantable in a first, reduced volume, and which is subsequently
enlargeable to a second, enlarged volume such as by the application
of water or heat, or the removal of a restraint.
[0056] Various safety features to minimize the risk of rupture or
leakage of the hardenable media may be utilized, depending upon
design preferences. For example, a two-layer or three-layer or more
balloon may be utilized to reduce the risk of rupture. In addition,
the material of the single or multiple layers of the balloon may be
selected to minimize escape of volatile components from the curable
media. In one embodiment, a double balloon is provided having a
nylon inner layer and a PET outer layer.
[0057] In addition, the inflation pressure of the curable media may
be affected by the nature of the balloon 14. For example, a
polyethylene balloon having a wall thickness of about 0.001'' may
have a burst pressure of about 7 to 8 atmospheres. In that
embodiment, an inflation pressure of no more than about 4 to 5
atmospheres may be desired. A slightly higher inflation pressure,
such as on the order of from about 5 to about 6 atmospheres, may be
utilized with a nylon balloon. Relatively noncompliant materials
such as PET have much higher burst pressures (range of 10-20
atmospheres), as is well understood in the balloon angioplasty
arts.
[0058] In addition, the balloon contains a proximal valve as will
be discussed in additional detail below. Multiple valves may be
utilized, in series along the flow path, to reduce the risk of
failure and escape of hardenable media. As a further safety
feature, the deployment catheter may be provided with an outer
spill sheath in the form of an elongate flexible tubular body which
surrounds the deployment catheter and at least a proximal portion
of the balloon. This spill sheath provides an additional removable
barrier between the junction of the catheter and the balloon, and
the patient. If a spill occurs during the filling process, the
spill sheath will retain any escaped hardenable media, and the
entire assembly can be proximally retracted from the patient.
Following a successful filling of the balloon, the spill sheath and
deployment catheter can be proximally retracted from the patient,
leaving the inflated formable orthopedic fixation structure in
place.
[0059] FIG. 3 is a cross-sectional midline sagittal view of a bone
graft 50 that can be used in combination with the inflatable device
10 described above. The graft 50 can comprise autograft bone (i.e.,
a patient's own bone) that is, for example, harvested from the
iliac crest (hip), an allograft bone (i.e., donor bone from a
cadaver), which eliminates the need to harvest the patient's own
bone or another type of artificial or natural rigid prosthesis
inserted into the space created by the corpectomy. The graft 50
includes an outer surface 52 which is sized and configured
generally to fit within the space created by the corpectomy as the
diseased or damaged vertebral body or portion thereof is removed.
In a modified embodiment, the graft 50 can be configured to fit
within a portion of a vertebrae bone that has been removed.
[0060] Within the outer surface, the graft 50 includes inner
surface 54, which is defines a bore configured to receive the
inflatable device 10 described above. A channel or opening 56 can
extend from the outer surface 52 to the inner surface 54 such that
a delivery catheter (as will be described in more detail below) can
be used to insert and inflate the device within the inner surface
54. The opening 56 can be preformed into the graft 50 or created in
situ. Once inflated, the device 10 occupies the cavity defined by
the inner space 54 providing the graft 50 with additional strength
and density.
[0061] In a modified embodiment, the graft 50 and inner surface 54
define a cavity configured to receive a hardenable or curable media
without the use of a balloon. That is, the graft itself constrains
the hardenable or curable media and the media is injected directly
into the graft 50. In yet another embodiment, the graft 50 and
device 10 are coupled and inserted together into the patient. An
injection device is then used to inflate the device 10.
[0062] The device 10 may be used in combination with various
medicines and agents. In particular, it can be advantageous to use
the device 10 in combination with an orthobiologic. Orthobiologics
refer generally to treatment agents that are used to replace,
repair, and/or regenerate damaged tissue and/or bones.
Orthobiologics include osteoinductives, also known as growth
factors, which are a type of orthobiologics that are configured for
regenerating bone. Examples of osteoinductives include proteins
that activate the formation of new bone. Another type of
orthobiologic is osteoconductive bone replacement materials
(resorbable or non-resorbable), which assist bone regeneration by
providing a scaffold that supports the ingrowth of capillaries and
provides a host bed for new cells.
[0063] The agent can be applied in a separate step during the
procedure or integrated into the device. For example, the balloon
14 can be coated with the agent or the agent can be embedded within
the balloon 14. The device 10 can also be configured to deliver the
agent as it is deployed. For example, as described above, in one
embodiment, the balloon 14 comprises a first, inner layer which
restrains the hardenable media. A second, outer layer is coaxially
disposed about the first layer, and is provided with a plurality of
apertures or a microporous structure. An infusion lumen is provided
in the delivery device for providing communication between a
proximal infusion port and the space in between the inner and outer
balloon layers. In this manner, suitable orthobiologics or bone
matrix material such as a hydroxyapatite preparation can be
injected into the central lumen and through the perforations to
promote bone in-growth and fusion with the adjacent spinal bone
material.
[0064] Delivery Device
[0065] With reference now to FIGS. 4-8, an exemplary embodiment of
a deployment system for deploying the inflatable corpectomy device
10 described above will now be described. As shown, the system
comprises a delivery catheter 100 which deploys the implantable
inflatable orthopedic device 10. The delivery catheter 100
preferably includes an elongate, flexible tubular body 104, having
a proximal end 106 and a distal end 108. For certain applications,
however, in which direct linear access is intended, the tubular
body 104 may be substantially rigid. The tubular body 104 includes
one or more passages or lumens extending axially through the body,
depending upon the desired functionality of the device.
[0066] The overall length and cross sectional dimensions of the
delivery catheter 100 may be varied, depending upon the intended
clinical application. In a device intended for inserting the device
10 in percutaneous or minimally invasive manner into a space
between an upper and lower vertebrae, for example, the tubular body
104 will generally have a length within the range of from about 15
cm to about 50 cm, and a diameter within the range of from about 2
mm to about 6 mm.
[0067] Percutaneous insertion of the delivery catheter 100 may be
facilitated by the provision of a removable elongate stiffening
wire 122, extending through a lumen such as inflation lumen 130
(see FIG. 5) from the proximal end 106 of tubular body 104, to the
distal end 108 of tubular body 104. Optionally, the stiffening wire
122 extends into, and even all the way to the distal end 18 of the
orthopedic device 10, to provide support and column strength to the
device 10, which may be desirable during tissue penetration. The
distal end of the stiffening wire 122 may be connected to a coil
approximately 8 cm in length to allow for a degree of
flexibility.
[0068] FIG. 5 shows a cross-sectional view through the elongate
body 104, showing (not to scale) an inner sleeve 110 and an outer
sleeve 112. The inner sleeve 110 defines a first, inflation lumen
130, while a second, venting lumen 132 is defined by the annular
space between the inner sleeve 110 and outer sleeve 112. The
inflation lumen 130 is adapted to receive the elongate stiffening
wire 122 in a sliding fashion through a proximal opening 127 on
inner sleeve 110, which in turn extends axially into the outer
sleeve 112 by way of port 126 in catheter manifold 124. Although
the illustrated embodiment has a dual lumen, concentric or coaxial
configuration, three or more lumen may alternatively be provided,
depending upon the desired capabilities of the catheter. A single
lumen catheter may also be provided, to accommodate a removable
stiffening wire, if utilized, and to facilitate inflation of the
implantable device. Alternatively, a two or more lumen catheter
shaft may be fabricated, extruded or otherwise formed with the
lumen in a side-by-side configuration.
[0069] With reference to FIGS. 4 and 6, the deployment device 100
further comprises a manifold 124, located at the proximal end 106
of the elongate tubular body 104. The catheter manifold 124
provides a maneuvering handle for the health care professional, and
supports an inflation port 126 and a vent port 128. Either or both
the inflation port 126 or the vent port 128 may be provided with a
coupling, such as a luer-lock fitting for connection to associated
devices as is known in the art. For example, a luer or other
connector on the inflation port 126 facilitates connection to a
source of pressurized inflation media in a conventional manner. The
vent port 128 may be connected to a syringe or other device to draw
a vacuum, to evacuate air from the balloon prior to infusion of the
hardenable media.
[0070] The manifold 124 may also include an injection port for
allowing injection of radiopaque contrast fluid to enable
visualization of the delivery device on a fluoroscope. The proximal
manifold 124 may be machined or injection molded of any of a
variety of known suitable materials such as PTFE, ABS, nylon,
polyethylene, polycarbonate, or others known in the art. A
precision gasket may also be provided, which seals securely around
the inner sleeve 110, prohibiting fluid loss.
[0071] Catheter manufacturing techniques are generally known in the
art, including extrusion and coextrusion, coating, adhesives, and
molding. The catheter of the present invention is preferably made
in a conventional manner. The elongate shaft of the catheter may be
extruded, using polymers such as Nylon, PEBAX, PEEK, PTFE, PE or
others known in the catheter arts, the stiffness of which may be
selected as appropriate. Material selection varies based on the
desired characteristics. The joints are preferably bonded.
Biocompatible adhesives or heat bonding may be used to bond the
joints. The balloon and stent are also made in a conventional
manner.
[0072] Referring to FIGS. 4A and 4B, the illustrated elongate
tubular body 104 comprises the outer sleeve 112 and the inner
sleeve 110 movably positioned within the outer sleeve 112. The
inflatable device 10 is removably carried by or near the distal end
108 of the outer sleeve 112. Alternatively, the inflatable device
10 may be removably carried by the inner sleeve 110. The inner
sleeve 110 may extend into the inflatable device 10, as
illustrated. The inflation lumen 130 is therefore in communication
with the interior cavity 12 of the inflatable device 10. The
inflation media can thus be infused through the inflation portion
126 (or opening 127) located at the manifold 124 to fill the cavity
12.
[0073] The balloon 14 may be removably attached to the tubular body
104 by a slip or friction fit on the distal end 108 of the outer
sleeve 112 or on the inner sleeve 110. A variety of alternative
releasable attachments may be used between the outer sleeve 112
and/or inner sleeve 110 and the proximal end 16 of the balloon 14,
such as threaded engagement, bayonet mounts, quick twist
engagements like a luer lock connector, and others known in the
art. In each of these embodiments, a first retention surface or
structure on the outer sleeve 112 and/or inner sleeve 110
releasably engages a complimentary surface or retention structure
on the proximal end 16 of the balloon 14 as will be apparent to
those of skill in the art.
[0074] The balloon 14 preferably comprises a self-sealing valve 160
which prevents the hardenable media from leaking once the delivery
catheter 100 is detached from the balloon 114. Valve 160 is
provided for closing the pathway between inflation lumen 130 and
inner cavity 146. Valve 160 may be located at the proximal end 16
of inflatable device 10. A variety of different valves may be used
as will be recognized by those of skill in the art, such as a slit
valve, check valve, duck-billed or flap valve. Alternatively, a
stopper may be provided which can be placed within the pathway to
prevent leakage.
[0075] Referring to FIG. 9A, a duck bill valve is schematically
illustrated. This valve includes at least a first, and preferably,
two or more coaptive leaflets 161 and 163, which incline towards
each other in the distal direction as will be understood by those
of skill in the art. Distal advancement of the inner sleeve 110
and/or pressurized media through the valve 160 forces the coaptive
leaflets 161 and 163 apart, to facilitate introduction of the
hardenable media. Upon removal of the inner sleeve 110, the
coaptive leaflets 161 and 163 return to a closed configuration to
inhibit or prevent the escape of hardenable media. A single leaflet
161 may be utilized, in the form of a flapper valve.
[0076] An alternate valve is illustrated in FIGS. 9B and 9C, and in
an assembled device in FIG. 4B. In this valve, a tubular support
structure 165 is provided with a closeable cap 167. The closeable
cap 167 may be formed from any of a variety of highly flexible
polymeric materials, such as silicone, neoprene, latex, or others
known in the art. Cap 167 may be formed such as by dip molding or
liquid injection molding, followed by the provision of a slit or
potential opening 169.
[0077] The valve 160 may be connected to or formed with the
inflatable device 10 in any of a variety of manners, as will be
appreciated in view of the disclosure herein. In the illustrated
embodiment, the balloon 14 is provided with a proximally extending
neck 15 which carries the valve 160 therein. The tubular body 165
having the cap 167 thereon is positioned concentrically within the
proximal neck 15, as illustrated in FIG. 4B. Alternatively, the
valve 160 may be positioned within the balloon 14, i.e., distally
of the proximal shoulder of the balloon 14.
[0078] Additional details of one detachable connection between the
delivery system and the implantable device is illustrated in FIG.
4B. As illustrated therein, a tube 161 extends distally from the
outer sleeve 112. Tube 161 may comprise any of a variety of
materials, which exhibit sufficient structural integrity for the
intended use. In one embodiment, tube 161 is a metal hypotube
having an inside diameter of about 0.085'' to about 0.086 and a
wall thickness of about 0.001'' to about 002''. The tube 161 in the
illustrative embodiment extends for a distance of about 0.50 mm to
about 0.75 mm beyond the distal end of the outer sleeve 112.
[0079] The tube 161 extends into a sliding fit with a tubular
support structure 163 which may be positioned in a proximal neck
portion 15 of the balloon 14. When positioned as illustrated, the
tube 161 ensures that the valve 160 is open, so that the inner
sleeve 110 may extend axially therethrough into the balloon 14.
[0080] In addition, the inside diameter of the tube 161 is
preferably sufficiently larger than the outside diameter of the
inner sleeve 110 to provide an annular passageway in communication
with the vent lumen 132. This structure ensures that the interior
12 of the balloon 14 remains in communication with the proximal
vent port by way of a vent lumen 132 extending throughout the
length of the assembly. In the illustrated embodiment, the outside
diameter of the inner sleeve 110 is about 0.082'' to about 0.084'',
and the inside diameter of the tube 161 is about 0.085'' to about
0.086''. Following infusion of the curable media into the balloon,
the inner tube 110 and tubular body 161 are both proximally
retracted from the balloon, thereby enabling the valve 160 to close
as is described elsewhere herein.
[0081] When fully inflated, as shown in FIG. 8, the balloon 14 has
an inflated profile with a cylindrical disk-type shape.
[0082] FIG. 10 illustrates the structure of an accelerator for
accelerating the curing of the curable media in one embodiment of
the invention. In this embodiment, the accelerator comprises a
heating coil 300 within the device 10 such as concentrically around
the distal end of the inner sleeve 110 of the elongate tubular body
104 of a delivery catheter 100. While the heating coil 300 is shown
coiled around the exterior surface of the distal end of the inner
sleeve 110, it can also be fitted inside the distal end of the
inner sleeve 110, or embedded within the distal end of the inner
sleeve 110. The distal portion of the sleeve 110 may be provided
with a detachable joint at the proximal end 116 of the balloon 114
such that it is left behind within the implantable device 102
following removal of the delivery catheter 100. A variety of
releasable attachments may be used, such as threaded engagements,
bayonet mounts, quick twist engagements like luer lock connectors,
or others known in the art.
[0083] It should be appreciated that the accelerator is not
necessary a part of the delivery catheter 100. FIG. 11
schematically illustrates another embodiment in which the
accelerator is built into the inflatable orthopedic device 10. As
disclosed above, a variety of structures may be provided such as a
reinforcement element 120 in the cavity 12 of the balloon 14, such
as carbon fibers, titanium rods, or tubular stents. If the
reinforcement element 120 is made from electrically conductive
materials, it can also function as a resistive heating element. In
FIG. 11, a metallic stent is illustrated. Titanium rods and carbon
fibers may also be used. Electrical contacts 310 and 312 for
conducting a current through the reinforcement element 120 are
incorporated into the releasable attachment, such as a concentric
sliding fit connection, used between the outer sleeve 112 and/or
inner sleeve 110 and the proximal end 16 of the balloon 14. These
electrical contacts engage complimentary contacts on the outer
sleeve 112 and/or inner sleeve 110 to complete an electric circuit
with a proximally located power supply for running the resistive
heating element.
[0084] In order to accomplish the objective of accelerating
polymerization of the epoxy or other hardenable media, the heating
element preferably elevates the temperature of the epoxy to a point
above normal body temperature. Temperatures at the heating element
of at least about 43.degree., preferably at least about 50.degree.,
and, under certain circumstances as high as 60.degree. C. or more
are desirable to produce an optimal cure rate. However, the outside
of the implant is preferably not heated to the extent that it
causes localized tissue necrosis. Tissue necrosis occurs at
approximately 45.degree. C. Thus, the heat source preferably sets
up a temperature differential between the surface of the implant
and the interior of the implant. This may be accomplished in
several ways, such as, for example, selecting materials and
thickness of the outer flexible wall 14 to provide thermal
insulation of the adjacent tissue from heat generated by the
heating element. As an alternative or in addition, heat sink
structures may be provided at or near the outer surface of the
orthopedic device 10. A flow path such as an annular space formed
within a double walled balloon may be utilized to circulate a
coolant such as saline or other circulating cooling fluid. Such
measures preferably permit the heating element to be heated as high
as 50.degree. C. or higher, while maintaining the outside surface
of the device 10 at a temperature of no more than about 45.degree.
C., and, preferably no more than about 43.degree. C.
[0085] Excessive temperature can also be reached transiently, such
as at the beginning of a heating cycle when the temperature may
temporarily overshoot the 45.degree. C. desired maximum. In certain
embodiments, the initial temperature overshoot can be eliminated or
reduced by appropriately driving the power to the heating element
as is discussed in detail below. The driver circuitry preferably
brings the heating element up to operating temperature rapidly,
while minimizing the risk of thermal overshoot beyond a
predetermined maximum. All of the foregoing measures preferably
allow a sufficient curing of the hardenable media to limit the
required period of immobility to no more than about 2 hours,
preferably no more than about 1 hour and, optimally no more than
about 45 minutes post implantation. Although a complete cure is not
required within this time window, a sufficient cure is desirable
that the patient need not be immobilized beyond the initial cure.
Thereafter, the hardenable media will continue to harden, such as
over the next few hours or even days, but with little or no
restriction on the patient's activities.
[0086] The resistive heating element, whether the heating coil 300,
the reinforcement element 120, or other structure, may be made from
material with either a positive or negative temperature coefficient
of resistance, e.g., electrical resistance either directly or
indirectly proportionate to temperature, respectively. The
temperature may be monitored by measuring the DC voltage across the
resistive heating element, for the voltage is directly proportional
to resistance for a given current, and the temperature coefficient
of resistance is known. Alternatively, by measuring the voltage,
current and phase of the drive system, the resistance of the
heating element and thus its temperature can be calculated by a
microprocessor or dedicated circuitry.
[0087] Alternatively a thermistor 314 may be used to monitor the
temperature of the inflatable orthopedic device 102. Thermistors
are well known in the art. Using one or more separate thermistors
314 would entail more electrical contacts (not shown) as another
electrical loop in addition to the one running the heating element
may be necessary. Other methods of measuring the temperature
include the use of an optical fiber in conjunction with a thermally
reactive material, a coaxial plunger in conjunction with a thermal
bulb, or a semiconductor temperature sensor or junction (such as a
diode) carried by the orthopedic implant. A bimetallic heating
element may function similarly to a circuit breaker and
self-regulate.
[0088] Additional details and embodiments of an accelerator for the
device 10 can be found in U.S. Pat. No. 6,875,212, which has been
incorporated by reference into this application.
[0089] In the embodiments described above, a valve and/or a
detachable connection is provided between the device 10 and the
deployment catheter 100. FIG. 12 illustrates an embodiment in which
the device 10 and inflation lumen 130 are semi-permanently or
permanently coupled together. In one embodiment, the inner sheath
110 is coupled to the proximal end 16 of the balloon 14 by a heat
bond or adhesive. In another embodiment, the balloon 14 is
shrink-fitted onto the sheath 110. This places inflation lumen 130
of the catheter 100 in fluid communication with the cavity 12 of
the balloon 14. In another embodiment, the balloon 14 is integrally
formed with at least a portion of the catheter 100 which defines
the inflation lumen 130. In such an embodiment, the device 10 is
detached from the catheter 100 by physically separating by cutting
or otherwise separating the balloon 14 from the catheter 100.
Preferably, this is done after the hardenable material is
sufficiently cured such that separation from the catheter will not
cause the balloon 14 to deflate.
[0090] Methods of Use
[0091] Although the application of the present invention will be
disclosed in connection with corpectomy, the methods and structures
disclosed herein are intended for various other spinal and
applications, as will be apparent to those of skill in the art in
view of the disclosure herein. In addition, although the method is
described in the context of a single level fusion procedure in
which a single vertebral body or portion thereof is removed, the
method can also be extended to multiple level fusion
procedures.
[0092] In one embodiment, the method generally involves accessing
the diseased or damaged parts of a vertebrae bone. The diseased or
damaged parts are then removed using techniques and tools that are
well known in the art. The removal step can utilize open, minimally
open or percutaneous techniques. An inflatable corpectomy device,
as described above, is then inserted, preferably percutaneously,
into the space formerly occupied by the removed or damaged
vertebrae bone or portions thereof. The corpectomy device
repositions or fixes the vertebrae below and above the replaced
vertebra, to a position within the vertebral column which is more
stable or which causes less morbidity.
[0093] Referring now to FIG. 13 through FIG. 18, there are shown a
series of drawings depicting various stages of an embodiment of a
method of replacing diseased or damaged vertebra or a portion
thereof. FIGS. 13-18 show partial cutaway, perspective, midline
sagittal views of a portion of a vertebral column undergoing the
method.
[0094] The method will now be disclosed and depicted with reference
to only one vertebrae, one of which is either diseased, damaged or
in need of replacement or repair. As shown in FIG. 13, the targeted
vertebrae bone 200 is positioned between two (upper and lower)
generally healthy vertebral bones, 202, 204. However, the method
can also be applied to two or more damaged vertebrae
simultaneously, as will be understood by those with skill in the
art with reference to this disclosure. Additionally, the method can
be used to replace the L5 vertebrae, using the cranial-ward portion
of the sacrum as the "vertebrae" with which L5 is anchored. It is
also possible to remove and replace only a portion of the damaged
vertebrae bone 200.
[0095] The present method comprises identifying a patient who is a
suitable candidate for undergoing the method. In connection with a
spinal application, a suitable candidate has one or more damaged or
diseased vertebrae. Further, the suitable candidate will normally
have either pain, loss of function or real or potential instability
which is likely due to the portions of the diseased or damaged
vertebrae that blocks or pinches the spinal cord. For example, a
suitable patient can have a disease or condition such as a tumor,
spondylosis, spondylolisthesis, vertebral instability, spinal
stenosis and degenerated, herniated, or degenerated and herniated
intervertebral discs, though actual indications require the
expertise of one of skill in the art as will be understood by those
with skill in the art with reference to this disclosure.
[0096] Next, the present method comprises making a stab incision in
the patient's skin overlying the patient's vertebral column at or
near the level of the vertebrae or portion of vertebrae to be
repositioned or fixed. In one embodiment, the incision is made
posteriorly at or near the level of the pedicle of the vertebra or
portion of vertebra to be replaced. The pedicle level is located
preferably by identifying the pedicle shadow using fluoroscopy.
While a posterior approached is described, those of skill of the
art will recognize an anterior, posterior and/or lateral approaches
or combinations thereof can also be used.
[0097] Then, as shown in FIG. 14, after the incision is made, the
diseased and damaged portions of the vertebrae bone are removed to
relieve pressure from the spinal cord. The removed bone forms a gap
203 positioned generally between the upper and lower vertebrae
bones 204, 202. Various techniques and devices (e.g., bone burrs
and cutters) can be used to remove the diseased and damaged bone
200 or portions thereof using either open, minimally open or
percutaneous techniques. In that corpectomy is a well-known
procedure, a detailed description of such devices and techniques is
not necessary.
[0098] As shown in FIG. 15, the disc levels below and above the
removed vertebral body can then be removed along with any vertebrae
fragments. The bone surfaces of the upper and lower vertebrae bones
202, 204 are then cleared and prepared to receive the inflatable
device. With continued reference to FIG. 15, bolts or screws 210
can be inserted into the upper and lower vertebrae bones 202, 204
to help surgeon maintain or manipulate the position of the upper
and lower vertebrae 202, 204 and the size of the gap 202.
[0099] With reference to FIG. 20, the screws or bone anchors 210
can be made a biocompatible material such as titanium or stainless
steel. Alternatively, bone anchors 210 may be made of a composite
material. Bone anchors 210 may also be made of a suitable medical
grade polymer.
[0100] The bone anchor 10 comprises a proximal portion 212 having a
proximal end 214 and a distal portion 216 having a distal end 218.
The proximal portion 212 typically comprises a head 320 for
engaging various gripping tools and plates. In a preferred
embodiment, the head 220 is also configured to mate with a driving
device, such as, tip of a screwdriver. The head 220 may comprise a
standard or Phillips slot for mating with the screwdriver. A
variety of slot configurations are also suitable, such as
hexagonal, Torx, rectangular, triangular, curved, or any other
suitable shape.
[0101] The distal portion 216 of bone anchor 210 typically
comprises threads 226 and a sharp tip 228. The bone anchor 210 can
include a central lumen (not shown) extending coaxially completely
through bone anchor 210 from proximal end 214 to distal end 218 and
configured to receive a guidewire. The bone anchor 210 may also
include at least one or more perforations to permits bone to grow
into bone anchor 210, stabilizing bone anchor 10 within the bone.
Additionally, bone matrix material such as a hydroxyapatite
preparation can be injected into the central lumen and through the
perforation to promote bone in-growth.
[0102] With reference now to FIG. 16, while the vertebral space 203
is open, the un-inflated or partially inflated device 10 is
positioned in the space 203 between the upper and lower vertebral
bodies 202, 205. In the illustrated embodiment, the device 10 is
inserted with the deployment catheter 100 using a posterior
approach. However, the catheter 100 and the device 10 can be
inserted using an anterior or lateral approach. In addition,
although percutaneous techniques are preferred, the device can also
be inserted using open on minimally open procedures. In one
embodiment, the device 10 is percutaneously inserted into the space
203 using a transpedicle approach in which a deployment catheter is
advanced through a pedicle 230 of adjacent vertebrae 202, 204.
[0103] If a percutaneous method is used, a guidewire can be
advanced through the patient's tissue or bone and into the space
203 between the upper and lower vertebral bodies 202, 204. Then,
the entire guidewire tract or portions thereof can be dilated using
a high pressure balloon or another type of expandable device and a
flexible introducer sheath may be passed over the guidewire along
the entire guidewire tract. The guidewire is removed after the
introducer sheath is placed. Alternatively, the device 10 is
advanced over the wire using the catheter 100 without the use of a
sheath.
[0104] Then, as shown in FIG. 17, the device is inflated with a
rapid setting, liquid polymer, or its equivalent, and the polymer
is allowed to fix the space formerly occupied by the damaged
vertebrae bone. In one embodiment, the liquid polymer is or
includes a two part epoxy or other hardenable media such as those
discussed elsewhere herein, and curing is accelerated by the
application of heat. Preferably, as the device is hardening, the
upper and lower vertebrae are maintained in the desired position by
the surgeon using the fixation devices 210. As mentioned above, the
device 10 can used in combination with the treatment agents that
are used to promote fusion, replace, repair, and/or regenerate
damaged tissue and/or bones.
[0105] FIG. 17A illustrates an embodiment in which the device 10 is
used in combination with a bone graft 50. In such an embodiment,
the bone graft 50 can be inserted into the space between the upper
and lower vertebrae bones 202, 204. The inflatable device 10 can
then be inserted through an opening 56, which is preformed or
formed in situ, and inflated to fill the bore 54 within the graft
50.
[0106] Finally, as shown FIG. 18, the delivery or pushing catheter
100 is separated from the device 10 by pulling on the catheter 100.
As mentioned above, the inflatable device 10 can comprise a
self-sealing valve which prevents the polymer from leaking once the
pushing catheter 100 is detached. In a modified embodiment, as
described above, with reference to FIG. 12, the device 10 does not
include a self sealing valve but is instead separated from the
balloon 14 by, for example, cutting the balloon 14 from the
inflation lumen 130, after the inflation material has sufficiently
cured.
[0107] As shown, in FIG. 18, the inflated device 10 closes the
vertebral space and is secured tightly between the upper and lower
vertebral bones 204, 202. FIG. 18 also illustrates the use of a
support structure 230 that bridges the upper and lower vertebral
bodies 204, 202, providing support while the device 10 or graft 50
fuses to the upper and lower vertebral bones 204, 202. In the
illustrated embodiment, a plate 232, often referred to as a
Z-plate, is provided between the upper and lower vertebral bodies
204, 202. The plate 232 generally includes an elongated rod 234
that bridges the two bodies and flanges 236 at the ends of the rod
234. The flanges 236 include openings 238 for receiving the
fixation devices 210 and additional anchoring elements if desired.
The plate 232 keeps the area secure while the area heals. Over
time, the bone graft 50 or device 10 will knit with the upper and
lower vertebral levels to create a solid bone segment.
[0108] With the procedure completed, the access incisions are
closed or sealed as necessary and routine postoperative care
administered.
[0109] In one embodiment, there is provided a kit for performing
methods of the present invention. The kit comprises a plurality of
bone screws and/or plates as described above for attachment to the
upper and lower vertebrae. The kit can also comprise other
components of a system according to one of the embodiments
described above, such as a guidewire, an inflatable corpectomy
device, the components of the polymer system to be mixed and
injected and/or a delivery catheter. In another preferred
embodiment, the kit also comprises inflatable corpectomy devices of
several sizes to accommodate different anatomies and patients.
[0110] Although the present invention has been described in terms
of certain preferred embodiments, other embodiments of the
invention including variations in dimensions, configuration and
materials will be apparent to those of skill in the art in view of
the disclosure herein. In addition, all features discussed in
connection with any one embodiment herein can be readily adapted
for use in other embodiments herein. The use of different terms or
reference numerals for similar features in different embodiments
does not imply differences other than those which may be expressly
set forth. Accordingly, the present invention is intended to be
described solely by reference to the appended claims, and not
limited to the preferred embodiments disclosed herein.
* * * * *