U.S. patent application number 10/804955 was filed with the patent office on 2004-10-28 for method and apparatus for treating a vertebral body.
Invention is credited to Hektner, Thomas R., Hochschuler, Stephen, Johnson, Wesley, Lipschultz, Tyler, Nickels, Kevin L., Wales, Larry.
Application Number | 20040215344 10/804955 |
Document ID | / |
Family ID | 27539133 |
Filed Date | 2004-10-28 |
United States Patent
Application |
20040215344 |
Kind Code |
A1 |
Hochschuler, Stephen ; et
al. |
October 28, 2004 |
Method and apparatus for treating a vertebral body
Abstract
An implantable container is used to stabilize or restore height
in a vertebral body. After insertion the container is filled with a
bone filler material such as bone cement.
Inventors: |
Hochschuler, Stephen;
(Dallas, TX) ; Johnson, Wesley; (Eden Prairie,
MN) ; Nickels, Kevin L.; (Bloomington, MN) ;
Hektner, Thomas R.; (Medina, MN) ; Wales, Larry;
(Maplewood, MN) ; Lipschultz, Tyler; (New Canaan,
CT) |
Correspondence
Address: |
Michael D. Beck
Suite 3000
111 Monument Circle
Indianapolis
IN
46204-5115
US
|
Family ID: |
27539133 |
Appl. No.: |
10/804955 |
Filed: |
March 19, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10804955 |
Mar 19, 2004 |
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09794873 |
Feb 27, 2001 |
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6740093 |
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60185323 |
Feb 28, 2000 |
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60220303 |
Jul 24, 2000 |
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60239216 |
Oct 10, 2000 |
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60239217 |
Oct 10, 2000 |
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Current U.S.
Class: |
623/17.12 |
Current CPC
Class: |
A61F 2/4601 20130101;
A61F 2002/30112 20130101; A61F 2230/0013 20130101; A61F 2002/30787
20130101; A61F 2002/30131 20130101; A61F 2230/0023 20130101; A61F
2310/00023 20130101; A61F 2002/30586 20130101; A61F 2/44 20130101;
A61F 2002/2835 20130101; A61F 2310/00017 20130101; A61B 17/7098
20130101; A61B 17/7097 20130101; A61F 2230/0004 20130101; A61F
2310/00293 20130101; A61F 2310/00353 20130101; A61F 2002/2817
20130101; A61F 2002/30156 20130101 |
Class at
Publication: |
623/017.12 |
International
Class: |
A61F 002/44 |
Claims
1. An implantable device for insertion into a cavity in a vertebral
body comprising: a container having a wall membrane; said wall
membrane defining an interior and an exterior of said container and
at least one hole connecting the interior with the exterior; and a
fill tube coupled to said container at a location proximate an edge
of said container for injecting a flowable bone filler material
into said container such that said bone filler leaves said interior
and enters said vertebral body.
2. The device of claim 1 wherein said container is substantially
tubular in shape.
3. The device of claim 1 wherein said wall membrane is elastic.
4. The device of claim 1 wherein said wall membrane is
inelastic.
5. The device of claim 1 wherein at least one of said wall
membranes is woven.
6. The device of claim 1 wherein said wall membrane is porous.
7. The device of claim 1 wherein said wall membrane is not
porous.
8. The device of claim 1 further comprising a septum located
adjacent said container and in fluid communication with said
interior for permitting the sealing entry of a filling device.
9. The device of claim 1 wherein said membrane is radiopaque.
10. The device of claim 1 wherein said membrane is
radio-translucent.
11. The device of claim 1 further comprising a delivery tube,
wherein said container is everted within said delivery tube.
12. An implantable device for insertion into a cavity in a
vertebral body comprising: an upper wall member; a lower wall
member; a circumferential wall member connecting said upper wall
member and said lower wall member; and a set of ribs extending
between said upper wall member and said lower wall member, forming
a set of compartments therebetween.
13. The device of claim 12 wherein said upper and lower wall
members have a substantially horseshoe shape.
14. The device of claim 12 wherein said upper and lower wall
members have a substantially triangular shape.
15. The device of claim 12 wherein said upper, lower and
circumferential wall members define a container that is
substantially cylindrical in shape.
16. The device of claim 12 wherein at least said circumferential
wall member is elastic.
17. The device of claim 12 wherein at least said circumferential
wall member is inelastic.
18. The device of claim 12 wherein at least one of said upper,
lower and circumferential walls is woven.
19. The device of claim 12 wherein at least one of said upper,
lower and circumferential walls is porous.
20-24 (cancelled)
25. An implantable device for insertion into a cavity in a
vertebral body comprising an expandable container including an
upper wall member, a lower wall member, and a circumferential wall
member, said wall members together defining a single chamber.
26. The device of claim 25 wherein said upper and lower wall
members have a substantially horseshoe shape.
27. The device of claim 25 wherein said upper and lower wall
members have a substantially triangular shape.
28. The device of claim 1, wherein said container is expandable
under pressure from the flowable bone filler injected into said
container.
29. The device of claim 28, wherein said container is expandable
from a first configuration sized for percutaneous introduction
through a cannula to a larger second configuration sized to fill
the cavity in the vertebral body.
30. The device of claim 1, wherein said fill tube is removably
coupled to said container.
31. The device of claim 30, wherein said fill tube includes an area
of weakness adjacent said container adapted to break to remove said
fill tube from said container.
32. The device of claim 6, wherein said wall defines a plurality of
holes symmetrically disposed about said container.
33. The device of claim 6, wherein said wall defines a plurality of
holes asymmetrically disposed about said container.
Description
CROSS-REFERENCE TO RELATED CASES
[0001] The present case claims the benefit of the following
Provisional Applications: "Cavity Sealing Barrier", Ser. No.
60/185,323, filed Feb. 28, 2000; "Implant for Hard Bones", Ser. No.
60/220,303, filed Jul. 24, 2000; "Vertebral Body Sealing Device and
Method", Ser. No. 60/239,216, filed Oct. 10, 2000; "Hydraulic
Distraction with Permeable Membrane", Ser. No. 60/239,217, filed
Oct. 10, 2000 and incorporates each of these by reference in their
entirety.
FIELD OF THE INVENTION
[0002] The present invention relates generally to the treatment of
bones and more particularly to the treatment of the vertebral
bodies found in the human spine.
BACKGROUND OF THE INVENTION
[0003] The human spine consists of a complex set of interrelated
anatomic elements including a set of bones called vertebral bodies.
Intervertebral discs separate most vertebral bodies. These discs
includes a "spongy" nucleus pulpous surrounded by an annulus
fibrosis "membrane". The annulus fibrosis connects the opposed
endplates of adjacent vertebral bodies. All of these structures
together with muscles act to provide motion, stability and
protection for the spine. When healthy, these structures
effectively protect the spinal cord and allow for normal
motion.
[0004] However there are many disease states and aging processes
that impact the patient. Osteoporosis and metastatic disease reduce
the structural integrity of the vertebral bodies, predisposing them
to fracture. Vertebral fractures can lead to loss of vertebral
height which can exacerbate existing neurological condition or it
can predispose the spine to other symptoms. Back pain often results
from these conditions. Vertebroplasty is an effort to stabilize
these fractures and to alleviate this source of pain.
[0005] Generally, fractures and loss of height if not treated
results in a cascade of injury which is undesirable. For this
reason various efforts have been directed at stabilizing and
restoring the natural vertebral bodies of the back. Efforts have
also been directed to replacing the vertebral bodies. condition or
it can predispose the spine to other symptoms. Back pain often
results from these conditions. Vertebroplasty is an effort to
stabilize these fractures and to alleviate this source of pain.
[0006] Generally, fractures and loss of height if not treated
results in a cascade of injury which is undesirable. For this
reason various efforts have been directed at stabilizing and
restoring the natural vertebral bodies of the back. Efforts have
also been directed to replacing the vertebral bodies.
[0007] U.S. Pat. No. 5,108,404 to Scholten et al among others
teaches a technique for height restoration that uses a bone cement
product introduced into a cavity after a cavity has been made with
an inflatable device. One problem with this system is the
extravasation of bone cement to sensitive areas. Another problem is
the difficulty of obtaining consistent control of height
restoration with the Scholten system.
SUMMARY
[0008] In contrast to the prior art, the present invention involves
both a container device that is permanently implanted and a method
of using the container to stabilize the vertebral body or to
restore height to the vertebral body.
[0009] In one embodiment the container is porous to the bone filler
material. In another embodiment the container is impermeable to the
bone filler material. In each embodiment the container controls and
regulates the delivery of bone filler material into the vertebral
body.
[0010] In one embodiment the container is flexible and conformal to
the cavity. In another embodiment the container has a fixed shape
which conforms to the cavity shape when deployed.
[0011] In one embodiment of the method, the bone filler is injected
until the cavity is completely filled stabilizing the vertebral
body. In another embodiment of the method the bone filler is
injected and displaces the endplates of the vertebral body
"restoring height" through a hydraulic jacking effect and
stabilizing their vertebral body.
[0012] There are numerous bone filler materials which can be used
to fill the container including bone cement and other materials.
However it is a general property of the bone fillers that they must
be injectable in a fluid state and that they harden.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] Throughout the several views of the drawings there are shown
illustrative embodiments of the inventions in which like reference
numerals indicate equivalent or identical structure, wherein:
[0014] FIG. 1 is a sectional view of a vertebral body;
[0015] FIG. 2 is a view of a vertebral body in elevation;
[0016] FIG. 3 is a view of a vertebral body in elevation;
[0017] FIG. 4 is a view of a vertebral body with items shown in
phantom view;
[0018] FIG. 5 is a view of a vertebral body with items shown in
phantom view
[0019] FIG. 6 is a view of a vertebral body with items shown in
phantom view
[0020] FIG. 7 is a view of a vertebral body with items shown in
phantom view
[0021] FIG. 8 is a view of a vertebral body with items shown in
phantom view
[0022] FIG. 9 is a view of a vertebral body with items shown in
phantom view
[0023] FIG. 10 is a view of a vertebral body with items shown in
phantom view;
[0024] FIG. 11 is a view of a vertebral body with items shown in
phantom view;
[0025] FIG. 12 is a view of an embodiment of a porous container in
use;
[0026] FIG. 13 is a view of an embodiment of a porous
container;
[0027] FIG. 14 is a view of a porous container in a cutaway
vertebral body;
[0028] FIG. 15 is a view of a container in isolation;
[0029] FIG. 16 is a view of a container in isolation;
[0030] FIG. 17 is a perspective view of a container in a vertebral
body;
[0031] FIG. 18 is a perspective view of a container in a vertebral
body;
[0032] FIG. 19 is a perspective view of a container in a vertebral
body;
[0033] FIG. 20 is a perspective view of a container in a vertebral
body;
[0034] FIG. 21 is a perspective view of a container in a vertebral
body
[0035] FIG. 22 is a perspective view of a container in a vertebral
body
[0036] FIG. 23 is a view of a tubular container;
[0037] FIG. 24 is a view of a tubular container in use;
[0038] FIG. 25 is a view of a fill tube construction;
[0039] FIG. 26 is a view of a fill tube construction;
[0040] FIG. 27 is a view of a fill tube construction; and,
[0041] FIG. 28 is a view of an alternate porous container
embodiment.
DETAILED DESCRIPTION
[0042] The various container devices and the methods for using the
container devices are disclosed in the context of the treatment of
vertebral bodies. It should be recognized that the inventions may
be used in other bones which present the same or similar
pathologies, including but not limited to tibial plateaus, distal
radius fractures, calcaneous fractures.
[0043] FIG. 1, FIG. 2 and FIG. 3 taken together are intended to
show a cavity creation process that precedes treatment with the
devices and methods of the invention. In general cavity creation
techniques are well known and they may include the creation of a
cavity with a balloon device as is known in the art.
[0044] FIG. 1 shows a vertebral body 10 in partial cross section.
The exterior portion of the vertebra is dense cortical bone and the
interior is porous cancellous bone which is labeled 12 in the
figure. The cavity 14 is depicted by the dashed outline in the
drawing and it is formed in the porous bone. The shape of the
cavity depends on the technique used to form it. This cavity is
made in a conventional way. For example a tool may be introduced
through extra-pedicular access tube 16 or transpedicular access
tube 18 and operated in the vertebral body. As seen in the drawing
the extrapedicular access tube 16 may have a larger diameter and
will be preferred by some surgeons. In general, the access approach
for cavity creation will also be used for the introduction of the
devices of the invention. These approaches will be used for the
methods of the invention.
[0045] FIG. 2 shows a collapsed vertebral body 10 in elevation with
a compression fracture and associated loss of height. The superior
endplate 20 has moved due to a fracture and normal loading. The
nominal height of the cavity formed in this vertebral body is
labeled "h1" in the figure. As the end plate moves the angle formed
between the superior endplate 20 and the inferior endplate 21
becomes acute which is undesirable. In the extreme case both sides
of the endplates fall to form a severely compressed rectangular
shaped vertebral body.
[0046] FIG. 3 shows a fractured vertebral body that requires
intervention. In this vertebral body the height of the cavity 14 is
indicated by the nominal height of the vertebral body labeled as
"h2" in the figure.
[0047] Taken together the FIGS. 1, 2 and 3 represent the formation
of a cavity 14 prior to treatment with device of the present
invention.
[0048] Taken together FIG. 4 FIG. 5 and FIG. 6 represent steps in a
method to stabilize a fractured vertebral body.
[0049] FIG. 4 shows a step in the method. In this drawing the
container 22 is coupled to a fill tube 24 shown in phantom view. In
this embodiment the container 22 is located at the distal end of a
fill tube 24. The container 22 and fill tube 24 are carried
together with the delivery tube 26. The motion arrow 28 indicates
that the delivery tube 26 and fill tube 24 are being moved together
into the surgically prepared cavity 14. The delivery tube 26 may be
the same device that is used to deliver the cavity tools as
discussed with reference to FIG. 1. Or the tube 26 may be a
separate device inserted through an alternate access aperture.
[0050] FIG. 5 shows the deployment process step where the delivery
tube 26 is retracted as indicated by motion arrow 30 while the fill
tube 24 and the attached container 22 remain stationary in the
vertebral body 10 cavity 14.
[0051] FIG. 6 shows the expansion of the container 22 within the
cavity 14. The bone filler material 36 seen in phantom view has
been loaded into the manually operated syringe 32 and the physician
is injecting the material through the fill tube 24 into the
container 22. The container 22 has unfurled and conformed to the
shape of the cavity 14. The unconstrained shape of this container
is generally cylindrical with spherical ends. This figure shows the
deployment of the container in to a cavity which is substantially
the same volume as the cavity 14. In this illustrative example the
volume of the container is larger than the volume of the cavity and
there is no stretching force applied to the impermeable container
membrane.
[0052] The coupling 34 between the fill tube and the syringe 32 may
be a conventional luer lock or other attachment device. Although a
syringe is an effective filler delivery tool it is expected that
physicians will use an alternative delivery system such as a an
extruder rod inserted directly into the fill tube to displace bone
filler into the container.
[0053] FIG. 7 depicts the preliminary preparation of a cavity 14 in
a collapsed vertebral body 10.
[0054] FIG. 8 shows an introduction step in the hydraulic jacking
process. In this illustration the container 22 and its attached
fill tube 24 are inserted into the vertebral body 10 together with
the delivery tube 26. The assembly is positioned in the cavity 14
proximate the end of the cavity. In this step care must be taken to
prevent pressurizing the device within the pedicle.
[0055] FIG. 9 shows a deployment step in the process. In this
illustration the container is fully deployed in the cavity 14 by
withdrawing the delivery tube (not shown) from the fill tube
leaving the container 22 exposed in the cavity 14.
[0056] FIG. 10 shows an injection step in the process. The
container 22 is filled through the fill tube 24 with a bone filler
materials 36. The manual syringe 32 or other injection device
injects the material at a sufficient pressure to create distraction
forces shown in the figure a superior force 40 and inferior force
42. These forces are sufficient to move the endplate 20 and end
plate 21 apart restoring height and angulation.
[0057] FIG. 11 shows a step of the process where an end point of
the method is reached. Here the container 22 is completely filled
and the original height of the vertebral body is restored. This end
point can be determined in any of several ways. For example an
inelastic fixed volume container can be used and the injecting
process stopped when resistance is felt through the hydraulic
connection with the container. An alternate approach is the
injection of a fixed volume of bone filler into an oversized
elastic or porous container 22. Also the physician may follow the
injection under fluoroscopy and limit injection through observation
of a real time image in combination with medical judgement. In this
instance the container can be inelastic or elastic. The final step
in the typical method will be to remove the fill tube 24 from the
container 22. This step will typically be performed after the bone
filler 36 material is "step up" and no longer in a low viscosity
state.
[0058] These initial figures depict the stabilization method and
the hydraulic jacking method performed with substantially
cylindrical containers. The membranes in the examples have all been
impermeable to the bone filler. In these process the container may
be elastic or inelastic as may be desired by the physician.
[0059] The stabilization method may be performed with all of the
container devices shown.
[0060] The hydraulic jacking method can be performed with the all
of the container devices with the exception of FIG. 13 and FIG.
14.
[0061] FIG. 12 shows an alternate container 22 with a membrane
perforated by a series of holes typified by hole 44. When placed in
a vertebral body the bone filler 36 extrudes from the holes and
interdigitates with the cancellous bone 12 inside the vertebral
body 10. It is difficult to illustrate this process but the cavity
14 has a wall that is porous so the bone filler interdigitates with
the cancellous bone matrix.
[0062] FIG. 13 shows a tubular fixed diameter form of the container
22 which can be used to control the delivery of bone filler to the
cavity. The container 22 approximates the size and shape of the
cavity, prior to bone filler injection. The holes in the device
distribute the bone filler to locations next to the holes.
[0063] FIG. 14 shows the container of FIG. 13 in operation in a
vertebral body 10.
[0064] One preferred method of use which can be performed with
porous containers involves the injection of a first volume of
relatively less viscous bone filler to promote interdigitation of
the cancellous bone. Next a second injection of bone filler
material with a different mechanical strength or chemical
composition is injected and it "pushes" against the initial or
primary injected material. This technique produces a gradient of
strength and elasticity through the repaired bone which mimics the
mechanical characteristics of the natural bone. The relatively
small diameter of this device allow the set of apertures to
distribute the various bone filler materials without moving the
device during injection.
[0065] Another preferred method involves the same two stage
injection process with a non-porous or impermeable container. In
this instance there is negligible interdigitation but the gradient
remains.
[0066] FIG. 15 is a container with an asymmetrical distribution of
holes so that the extrusion of bone filler occurs on one side of
the container. This construction may allow the container to be
moved within the vertebral body during injection of bone
filler.
[0067] FIG. 16 shows an asymmetrical container 22 where hole size
and distribution vary over the surface of the membrane. For example
hole 44 is larger than holes 45 which lie along the axis of the
fill tube 24. This asymmetry provides physician control of the
distribution and the flow of the bone filler materials into
specific regions of the vertebral body.
[0068] FIG. 17, FIG. 18 and FIG. 19 should be considered together.
This group of drawings depicts an alternate "horseshoe" shape for
the construction for the container 22. In each instance the fill
tube has been eliminated from the figure to improve clarity.
However it should be understood that at least one fill tube is used
with each container in these figures. All of the container devices
depicted in FIG. 17 through FIG. 20 can be made of porous or
non-porous membrane materials.
[0069] FIG. 17 is single chamber fixed volume device 22 which may
expand to a nominal height in the vertebral body 10.
[0070] FIG. 18 is a segmented horseshoe shaped container 22 device
with a horizontal rib 70 that divides the container into two
separate structures. The inner of the membrane 71 may be continuous
with this rib 70 or weep holes may be provided to facilitate flow
of bone filler within the device. The exterior surface of the
membrane 73 may be porous or impermeable to bone filler. In this
embodiment the rib 70 will effectively limit the height achieved in
the vertebral body.
[0071] FIG. 19 is multi-chambered device with several lateral
compartments created by ribs typified by rib 74. In this embodiment
the chambers typified by chamber 75 limit the horizontal extent of
the growth of the container during the hydraulic jacking
process.
[0072] FIG. 20 is single chamber fixed volume device 22 with a
triangular "footprint".
[0073] FIG. 21 is a segmented triangular device with a horizontal
rib 76 defining two chambers.
[0074] FIG. 22 is multi-chambered device with several lateral
compartments created by ribs typified by rib 77.
[0075] FIG. 23 shows an alternate tubular embodiment of a single
chamber container 22 with a stylet 92 coupled to the most distal
end of the container 22. This elongate tubular container is
deployed by advancing the stylet 92 wire out of the delivery tube,
which drags the container membrane out of the delivery tube 26 or
the fill tube 24. In this device the container may be folded and
placed entirely everted in the fill tube. This construction will
allow the device to be safely delivered without the use of a
delivery tube thereby maximizing the inner diameter of the fill
tube.
[0076] FIG. 24 shows the alternate tubular embodiment of the
container in its partially filled configuration. In this
illustration the vertebral body 10 has had an oval cavity 14 formed
in the cancellous bone. The stylet 92 is used to force the
container 22 along the outer wall path of the cavity 14 and it is
then removed. Next bone filler material is injected through the
fill tube and the annular ring tubular container is filled.
[0077] FIG. 25 shows a simple slip fit between the fill tube 24 and
a complementary structure on the container 22. In this construction
a septum 82 is used to fill the container 22 though a fill needle
84. One advantage of this construction is the septum seals the
container and allows the container to seal while the bone filler
hardens.
[0078] FIG. 26 shows are area or zone of weakness 83 in the fill
tube 24 that preferentially breaks off to remove the fill tube from
the container.
[0079] FIG. 27 the toothed member 85 circulates around the axis of
the fill tube 24 and cuts of the fill tube away from the container
after the bone filler has hardened.
[0080] FIG. 28 shows the container formed as a porous woven
membrane 90. In use the bone filler 36 will exude from the area
between the woven fibers to permeate the cancellous bone. The woven
mesh will produce the same effect as an elastic membrane.
[0081] Various materials may be used to make the container
including, polyethylene Teflon, Gore-Tex, polybutylene
terephathlate, polyethylene terephathalate glycol, urethane and
urethane coated materials. The material or the construction can
give rise to elastic or inelastic structures both of which are
operable in the methods of the invention. The woven embodiments of
the porous container may also be made from metal meshes or screens
including titanium, elgiloy MP35 nitinol, stainless steel, or other
bio-compatible metals.
[0082] Various bone fillers contemplated within the scope of this
invention. Bone fillers are defined for this disclosure as any
substance used to stabilize the bone and includes but is not
limited to bone cement, human bone graft (allograft autograft),
synthetic derived bone substitutes such as calcium phosphate and
hydroxylapatite. Bone fillers may be supplemented with other
biologically active materials including but not limited to collagen
osteoinductive agents including bone morphogenic proteins. Other
known ceramic based materials can be used as well. Other known
bioresorbable polymers may be used as well.
[0083] Illustrative embodiments of the invention have been shown
but numerous modifications may be made without departing from the
scope of the invention which is defined by the appended claims.
* * * * *