U.S. patent application number 11/282910 was filed with the patent office on 2006-07-06 for expandable porous mesh bag device and methods of use for reduction, filling, fixation and supporting of bone.
This patent application is currently assigned to Spineology, Inc.. Invention is credited to John E. Kuslich, Stephen D. Kuslich.
Application Number | 20060149379 11/282910 |
Document ID | / |
Family ID | 37434183 |
Filed Date | 2006-07-06 |
United States Patent
Application |
20060149379 |
Kind Code |
A1 |
Kuslich; Stephen D. ; et
al. |
July 6, 2006 |
Expandable porous mesh bag device and methods of use for reduction,
filling, fixation and supporting of bone
Abstract
The invention provides a method of correcting numerous bone
abnormalities including bone tumors and cysts, avascular necrosis
of the femoral head, tibial plateau fractures and compression
fractures of the spine. The abnormality may be corrected by first
accessing and boring into the damaged tissue or bone and reaming
out the damaged and/or diseased area using any of the presently
accepted procedures or the damaged area may be prepared by
expanding a bag within the damaged bone to compact cancellous bone.
After removal and/or compaction of the damaged tissue the bone must
be stabilized.
Inventors: |
Kuslich; Stephen D.;
(Stillwater, MN) ; Kuslich; John E.; (Phoenix,
AZ) |
Correspondence
Address: |
PATTERSON, THUENTE, SKAAR & CHRISTENSEN, P.A.
4800 IDS CENTER
80 SOUTH 8TH STREET
MINNEAPOLIS
MN
55402-2100
US
|
Assignee: |
Spineology, Inc.
|
Family ID: |
37434183 |
Appl. No.: |
11/282910 |
Filed: |
November 18, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10440036 |
May 16, 2003 |
|
|
|
11282910 |
Nov 18, 2005 |
|
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|
Current U.S.
Class: |
623/17.12 |
Current CPC
Class: |
A61B 17/742 20130101;
A61F 2002/30448 20130101; A61F 2/44 20130101; A61F 2/4611 20130101;
A61F 2230/0071 20130101; A61F 2/461 20130101; A61F 2002/30069
20130101; A61F 2230/0082 20130101; A61B 2017/00004 20130101; A61F
2002/2832 20130101; A61F 2002/30593 20130101; A61F 2002/30261
20130101; A61F 2002/2892 20130101; A61B 2017/00557 20130101; A61F
2310/00353 20130101; A61F 2220/0058 20130101; A61B 17/68 20130101;
A61B 17/32002 20130101; A61B 17/1671 20130101; A61F 2002/2835
20130101; A61F 2/4601 20130101; A61B 17/1617 20130101; A61F
2002/30242 20130101; A61F 2002/448 20130101; A61F 2002/30451
20130101; A61F 2310/00293 20130101; A61B 17/3472 20130101; A61F
2/441 20130101; A61F 2002/30032 20130101; A61F 2002/30718 20130101;
A61B 17/1675 20130101; A61F 2002/30581 20130101; A61B 17/1668
20130101; A61F 2002/4635 20130101; A61B 17/8855 20130101; A61B
17/8805 20130101; A61F 2/0095 20130101; A61F 2/4607 20130101; A61F
2220/005 20130101; A61F 2250/0031 20130101; A61B 17/00234 20130101;
A61B 17/7098 20130101; A61B 2017/00261 20130101; A61F 2/34
20130101; A61F 2002/2817 20130101; A61F 2002/2828 20130101 |
Class at
Publication: |
623/017.12 |
International
Class: |
A61F 2/44 20060101
A61F002/44 |
Claims
1. A method of treating an vertebral body having a superior
endplate and an inferior endplate, comprising the steps of:
inserting a container into an vertebral body; deploying said
container within said vertebral body; injecting a bone filler
material into said container under pressure; whereby said pressure
supplies a distraction force to move said superior and inferior
endplates apart; and ending injection after said endplates have
moved apart.
2. A method of treating a vertebral body having a superior endplate
and an inferior endplate, comprising the steps of: inserting a
container into the vertebral body; deploying said container within
said vertebral body; injecting a bone filler material into said
container under pressure; whereby said pressure fills the container
to an expanded state to reach a degree of correction required for
the vertebral body; and ending injection after said degree of
correction is achieved.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional application of U.S. patent
Ser. No. 10/440,036, filed May 16, 2003, which claims priority to
U.S. patent application Ser. No. 09/909,667, filed Jul. 20, 2001,
which claims priority to U.S. Provisional Application No.
60/219,853 filed Jul. 21, 2000, the entirety of which is
incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] This invention relates to methods and devices for correcting
bone abnormalities and involves the use of a surgical mesh bag
which is inserted into a prepared cavity in bone. The bag is
inflated using bone replacement material to expand and fill the
cavity.
[0003] U.S. Pat. Nos. 5,549,679 and 5,571,189 to Kuslich, describe
a device and method for stabilizing the spinal segment with an
expandable, porous fabric implant for insertion into the interior
of a reamed out disc which is packed with material to facilitate
bony fusion. In the present invention, a similar bag is used to
correct bone abnormalities including, but not limited to, bone
tumors and cysts, tibial plateau fractures, avascular necrosis of
the femoral head and compression fractures of the spine.
[0004] U.S. Pat. Nos. 5,108,404 and 4,969,888 to Scholten et al.,
describe a system for fixing osteoporotic bone using an inflatable
balloon which compacts the bone to form a cavity into which bone
cement is injected after the balloon is withdrawn. The invention
requires the use of fluoroscopy to monitor the injection and to
help guard against cement leakage through fissures in bone.
Unfortunately, such leakage is known to occur in spite of these
precautions. Since such leakage may cause serious injury, including
paralysis, an improved device and method is needed.
[0005] U.S. Pat. No. 5,972,015 to Scribner et al., describes a
system of deploying a catheter tube into the interior of a vertebra
and expanding a specially configured nonporous balloon therewithin
to compact cancellous bone to form a cavity. The Scribner patent
approach utilizes a non-porous balloon which is inflated within the
bone to cause compression. The cavity thus formed, may then be
filled with bone cement. Unfortunately, the bag used by Scribner
may be ruptured during expansion to compact cancellous bone due to
sharp projections found within the cavity to be expanded. Filling
the cavity eventually formed could allow leakage of bone cement out
of the bone against vessels or nerves which may cause undesirable
complications.
[0006] The present invention involves an improvement of all of the
previous techniques and avoids complications that could occur with
the system of U.S. Pat. No. 5,972,015.
[0007] All U.S. patents, applications and all other published
documents mentioned anywhere in this application are incorporated
herein by reference in their entirety.
[0008] The art described in this section is not intended to
constitute an admission that any patent, publication or other
information referred to herein is "prior art" with respect to this
invention, unless specifically designated as such. In addition,
this section should not be construed to mean that a search has been
made or that no other pertinent information as defined in 37 C.F.R.
.sctn. 1.56(a) exists.
SUMMARY OF THE INVENTION
[0009] The invention provides a method of correcting numerous bone
abnormalities including bone tumors and cysts, avascular necrosis
of the femoral head, tibial plateau fractures and compression
fractures of the spine. The abnormality may be corrected by first
accessing and boring into the damaged tissue or bone and reaming
out the damaged and/or diseased area using any of the presently
accepted procedures, or the damaged area may be prepared by
expanding a bag within the damaged bone to compact cancellous bone.
After removal and/or compaction of the damaged tissue the bone must
be stabilized.
[0010] In cases in which the bone is to be compacted, the methods
and devices of this invention employ a catheter tube attached to an
inflatable porous fabric bag as described in U.S. Pat. Nos.
5,549,679 and 5,571,189 to Kuslich, the disclosures of which are
incorporated herein by reference. Those bags may be inflated with
less fear of puncture and leakage of the inflation medium than thin
walled rubber balloons. They may also be used over a Scribner
balloon to protect the balloon from breakage and eventually
seepage.
[0011] The devices of U.S. Pat. Nos. 5,549,679 and 5,571,189 to
Kuslich, additionally provide the surgeon with the advantage of
safely skipping the first balloon inflation steps of Scribner and
Scholten, by expanding the bag through introduction of fill
material, such as a bone repair medium thereby correcting the bony
defect and deformity and stabilizing it in one step of the
procedure.
[0012] As indicated above, the damaged bone may be removed by any
conventional reamer. Examples of reamers are described in U.S. Pat.
No. 5,015,255; U.S. patent application Ser. No. 09/782,176, to
Kuslich et al., entitled "Expandable Reamer" and filed Feb. 13,
2001; and U.S. patent application Ser. No. 09/827,202 to Peterson
et al., entitled "Circumferential Resecting Reamer Tool," filed
Apr. 5, 2001. Other examples of reamers are known and may be used.
After the damaged bone or tissue has been removed, bone repair
medium may then be inserted into the cavity thus formed, via a
catheter and expandable fabric bag as described in U.S. Pat. Nos.
5,549,679 and 5,571,189.
[0013] Alternatively, either a smaller than desired cavity may be
formed into the bone to be enlarged by compaction or the cavity may
be formed only by compaction through introduction of fill material
into the bag. In either case, the bag may be positioned over the
inflation balloon which is then inflated within the bone site to
provide the degree of compaction required. The bag may then be
filled with fill material, such as bone repair medium while the
balloon remains in place within the bag. Alternatively, the balloon
may be removed from the bag prior to filing the bag.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] A detailed description of the invention is hereafter
described with specific reference being made to the drawings in
which:
[0015] FIG. 1 is a side elevational view of a vertebra that is
fractured and in need of repair;
[0016] FIG. 2 is a side view of the vertebra of FIG. 1 being reamed
out with a reaming tool from the anterior approach;
[0017] FIG. 3 is a top view of the vertebra of FIG. 1 showing the
reamer forming a pair of cavities within the vertebra from the
anterior approach;
[0018] FIG. 4 is a side elevational view of the vertebra of FIG. 2
showing placement of an expandable fabric bag of the invention;
[0019] FIG. 5 is a top elevational view of the vertebra of FIG. 3
showing a second of two expandable fabric bags of the invention
being positioned;
[0020] FIG. 6 is a side view of a vertebra being reamed from a
posterior approach;
[0021] FIG. 7 is a top view of the vertebra of FIG. 6 with a bag in
place and a second cavity being reamed;
[0022] FIG. 8 is a side elevational view of the vertebra of FIG. 6
with an expandable fabric bag of the invention in place;
[0023] FIG. 9 is a top view of the vertebra of FIG. 7 with one bag
inflated and the second bag being deployed;
[0024] FIG. 10 is a side elevational view showing the vertebra
cavity being expanded with an expandable fabric bag about an
inflation device in cross-section;
[0025] FIG. 11 shows the bag system of FIG. 10 with the vertebra in
phantom to show the bag system;
[0026] FIG. 12 is a view similar to FIG. 10 showing a different
approach to the interior of the vertebra;
[0027] FIG. 13 is a view similar to FIG. 11 showing the approach of
FIG. 12;
[0028] FIG. 14 shows the bag of FIG. 12 in a closed, filled and
expanded position;
[0029] FIG. 15 is a top view of the bag system of FIG. 12 being
inflated through a catheter tube;
[0030] FIG. 16 shows a femoral head with avascular necrosis;
[0031] FIG. 17 shows the femoral head of FIG. 16 being reamed
out;
[0032] FIG. 18 shows placement of a bag system of the invention
within the cavity in the femoral head;
[0033] FIG. 19 is a side elevational view of a tibial plateau
fracture;
[0034] FIG. 20 is a side view of the fracture of FIG. 19 with a
cavity being formed with a reamer; and
[0035] FIG. 21 shows the tibial plateau fracture repaired with an
expanded inflatable fabric bag in place.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0036] In the following detailed description, similar reference
numerals are used to depict like elements in the various
figures.
[0037] FIG. 1 shows a typical vertebra 10 having compression
fractures 12 that is in need of repair. As indicated above the
damaged portion of the vertebra 10 may be reamed out, compacted, or
otherwise repaired. For example, FIG. 2 shows a reamer 14 entering
the vertebra 10 anteriorly to make an opening 15 and cavity 16.
Alternatively, multiple cavities 16 may be formed such as is shown
in FIG. 3.
[0038] As previously mentioned, the damaged portion of the vertebra
10 may be compacted in addition to or instead of being reamed out.
In FIG. 4, a delivery tube or catheter 20 is seen in the process of
delivering an expandable fabric bag 22 into the vertebra 10 or into
a cavity 16 present therein. As indicated, the cavity 16 may have
been created through reaming, compaction by the bag 22 or other
device, or by other means. Once the bag 22 is positioned within the
vertebra 10, the bag 22 may be inflated or expanded to the limits
of the cavity 16 thus formed through insertion or injection of fill
material 19 into the interior 21 of the bag 22.
[0039] FIG. 5 shows a single filled expandable fabric bag 22 in
place with a second expandable bag which is being inserted and
expanded within the cavity 16.
[0040] FIGS. 6-9 illustrate a procedure in which the opening 15 and
cavity 16 are created posteriorly. Regardless of the direction
through which the vertebra 10 is operated on, in all forms, the
cavity 16 which is formed is then filled with acceptable bone
replacement material.
[0041] Bone replacement material 19 may be one or more of the
following, or any other biocompatible material judged to have the
desired physiologic response:
[0042] A) Demineralized bone material, morselized bone graft,
cortical, cancellous, or cortico-cancellous, including autograft,
allograft, or xenograft;
[0043] B) Any bone graft substitute or combination of bone graft
substitutes, or combinations of bone graft and bone graft
substitutes, or bone inducing substances, including but not limited
to: Tricalcium phosphates, Tricalcium sulfates, Tricalcium
carbonates, hydroxyapatite, bone morphogenic protein, calcified
and/or decalcified bone derivative; and
[0044] C) Bone cements, such as ceramic and polymethylmethacrylate
bone cements.
[0045] The bone replacement material is inserted into the bag 22
via a needle, catheter 20 or other type of fill tool. The bone
replacement material expands the bag to the limits of the cavity
16.
[0046] The inventive bag 22 may be a small fabric bag, from about
one to about four cm in diameter, being roughly spherical in shape,
although other elliptical shapes and other geometric shapes may be
used. The bag is pliable and malleable before its interior space 21
is filled with the contents to be described. The material of the
bag 22 may be configured to take on the shape of the cavity in
which the bag is placed. While in this initial condition, the bag
may be passed, uninflated, through a relatively small tube or
portal, perhaps about three mm to about one cm in diameter.
[0047] The bag 22, such as may best be seen in FIG. 9, is
constructed in a special and novel way. The bag 22 may be
constructed of a fabric 23. Fabric 23 may be woven, knitted,
braided or form-molded to a density that will allow ingress and
egress of fluids and solutions and will allow the ingrowth and
through-growth of blood vessels and fibrous tissue and bony
trabeculae, but the fabric porosity is tight enough to retain small
particles of enclosed material, such as ground up bone graft, or
bone graft substitute such as hydroxyapatite or other
osteoconductive biocompatible materials known to promote bone
formation. The fabric 23 defines a plurality of pores 25.
Generally, the pores 25 of the fabric 23 will have a diameter of
about 0.25 mm or less to about 5.0 mm. The size is selected to
allow tissue ingrowth while containing the material packed into the
bag. If bone cement or other material is used which will not
experience bone ingrowth, the pores 25 may be much tighter to
prevent egress of the media from within the bag 22 out into the
cavity 16. This prevents leakage that could impinge upon nerves,
blood vessels or the like if allowed to exit the bone.
[0048] One or more of the pores 25 may be used as a fill opening
27, wherein the fabric 23 may be manipulated to enlarge a pore to a
diameter potentially greater than 5 mm but no more than about 1 cm.
Preferably, the fill opening 27 is less than about 5 mm in
diameter. Such a pore/fill opening 27 is sufficiently large to
allow a catheter, needle, fill tube or other device for inserting
or injecting fill material to pass through the fabric 23 and into
the interior 21 of the bag 22 without damaging the integrity of the
bag 22.
[0049] When the bag 22 is fully filled with fill material, the bag
will form a self-retaining shape which substantially fills the
cavity 16. Once sufficiently full, the fill tool used to place fill
material into the bag interior 21 is removed from the opening 27.
Where the opening 27 is not a pore 25 but rather a separate and
distinct opening in the bag 22, the opening 27 may have a set
diameter which requires sealing such as by tying, fastening,
welding, gluing or other means of closing the opening 27 after the
bag has been filled. Where the opening 27 is a pore 25, upon
removal of the catheter or fill tool from the opening 27 the fabric
23 will contract to reduce the diameter of the opening 27 to be
substantially similar to that of the other pores 25.
[0050] The size and density of the pores determine the ease or
difficulty with which materials may pass through the mesh. For
instance, very small pores (<0.5 mm) would prohibit passage of
all but the smallest particles and liquids. The pore size and
density could be controlled in the manufacturing process, such that
the final product would be matched to the needs of the surgeon. For
example, if methylmethacrylate bone cement were to be used, the
pore size would need to be very small, such as about less than 0.5
mm to about 1.0 mm, whereas, when bone graft or biocompatible
ceramic granules are used, pore sizes ranging from about 1.0 mm to
about 5.0 mm or more may be allowed. The fact that the fabric 23 is
properly porous would allow it to restrict potentially dangerous
flow of the fill material outside the confines of the bag.
[0051] The fabric is light, biocompatible, flexible and easily
handled, and has very good tensile strength, and thus is unlikely
to rip or tear during insertion and inflation. When the device is
inflated, the device expands to fill a previously excavated cavity
16.
[0052] The use of the term "fabric" herein is meant to include the
usual definition of that term and to include any material that
functions like a fabric, that is, the "fabric" of the invention
must have a plurality of pores 25 through which material and fluid
flow is allowed under the terms as described, and the "fabric" must
be flexible enough to allow it to be collapsed and inserted into an
opening smaller than the inflated bag size.
[0053] The bag 22 need not be woven and may be molded or otherwise
formed as is well known in the art. The preferred material may
provide the ability to tailor bioabsorbance rates. Any suture-type
material used medically may be used to form the bag 22. The bag may
be formed of plastic or even metal. In at least one embodiment, bag
22 is formed using a combination of resorbable and/or nonresorbable
thread. Bag 22 may include a fill opening 27 which may be a bushing
that could be a bioabsorbable and/or nonbioabsorbable plastic,
ceramic or metal. The opening 27 may also be hydroxyapatite, or it
could be plastic or metal. The opening 27 may also be characterized
as a pore 25, wherein a pore 25 of the fabric 23 has been expanded
to allow a catheter 20 or other fill device to pass into the
interior 21 of the bag 22. The bag 22 could be formed from a solid
material to which perforations are added. The bag 22 may be
partially or totally absorbable, metal, plastic, woven, solid, film
or an extruded balloon.
[0054] In embodiments of the present invention a damaged tissue of
a body, such as a vertebra 10 may be treated in accordance with the
following procedures such as are depicted in FIGS. 1-9:
[0055] Initially, the vertebra 10 needing repair is surgically
exposed by forming at least one cavity 16. The cavity or cavities
16 may be formed by several different means such as by reaming.
Reaming may be accomplished by several means such as including the
use of a reamer 14 such as, for example, the Kuslich Expandable
Reamer, U.S. Pat. No. 5,015,255, the entire content of which is
incorporated herein by reference. Next, the unexpanded mesh bag or
Expandable Fabric Bag Device (EFBD) 22 is inserted into the cavity
or cavities via catheter 20 or other means. At some point, the fill
material 19 is prepared for insertion or injection into the EFBD
22. Following preparation of the fill material 19, the material is
injected or otherwise inserted into the bag 22 using sufficient
pressure to fill the bag 22 to its expanded state, thus producing
rigidity and tension within the cavity or cavities 16 to reach the
degree of correction required by virtue of the compression
fractures. Finally, the fill opening 27 is closed to prevent egress
of inflation material 19.
[0056] FIGS. 10-15 show a form of the invention in which a balloon
30 and catheter tube 32 is employed. The balloon 30 is surrounded
by an expandable fabric bag 22 to protect the balloon 30 from being
punctured during the inflation steps and to remain in place to
prevent undesired egress of material injected into the cavity
formed in the bone. Balloon 30 may be any medical-grade elastomeric
balloon. The balloon 30 may be constructed from latex, urethanes,
thermoplasic elastomers or other substances suitable for use as an
expandable member. Examples of suitable balloons include, but are
not limited to: balloons utilized with the FOGARTY..RTM.. occlusion
catheter manufactured by Baxter Healthcare Corporation of Santa
Ana, Calif.; balloons of the type described in U.S. Pat. No.
5,972,015 to Scribner et al., and others. The methods involve
placement of the expandable fabric bag 22 of the invention about
the balloon 30 of the Scribner et al. device. The expandable bag 22
is left in place before the cavity 16 is filled with bone
substitute or bone cement. The expandable fabric bag 22 prevents
breakage of the balloon 30 and greatly limits the ability of fill
material from leaking out of the cavity through bone fissures where
it could cause damage.
[0057] As may best be seen in FIGS. 11, 13 and 15, the bag 22 may
include a neck 29 which extends outwardly from the bag 22 to
completely overlap the shape of balloon 30. The bag 22 and/or
balloon 30 may each have a variety of shapes and sizes.
[0058] If desired, the expandable fabric bag 22 may be used as the
sole inflation device, eliminating the Scribner et al. balloon 30
if the fabric porosity is tight and the inflation media is
reasonably viscous.
[0059] While many of the previous embodiments have described the
use of the bag 22 for repair of tissue such as a spinal body, in
FIGS. 16-18 show how the bag 22 may be used in treating avascular
necrosis of the femoral head. In FIG. 16, a femoral head 40 is
shown which is in need of repair. FIG. 17 shows the femoral head
being reamed out with a reamer 14, such as previously described.
The reamer 14 forms a cavity 16. In FIG. 18, a bag 22 is shown
within the cavity 16 formed within the femoral head 40. The opening
27 of the bag 22 is closed off after being filled and expanded with
bone substitute material.
[0060] In an alternative embodiment, the Scribner et al. balloon,
as previously described, may also be used with the bag 22 for
repair of the femoral head 40.
[0061] Turning to an embodiment of the invention shown in FIGS.
19-21, a tibial plateau 48 is shown having a fracture 50. The
fracture 50 is repaired by forming a cavity 16 with a reamer 14,
such as is shown in FIG. 20. As is shown in FIG. 21, once cavity 16
is properly reamed, bag 22 may be inserted therein and filled with
bone repair media 19.
[0062] Other tissue and bone abnormalities may also be treated with
the inventive methods and bag 22 described herein. The present
invention is not limited to only treatment of spinal bodies,
femoral heads, and tibial plateaus. The bag 22 and the methods of
treatment described herein, may be utilized throughout a mammalian
body to treat many types of bone and tissue abnormalities including
those described herein as well as others.
[0063] In addition to being directed to the specific combinations
of features claimed below, the invention is also directed to
embodiments having other combinations of the dependent features
claimed below and other combinations of the features described
above.
[0064] The above disclosure is intended to be illustrative and not
exhaustive. This description will suggest many variations and
alternatives to one of ordinary skill in this art. All these
alternatives and variations are intended to be included within the
scope of the claims where the term "comprising" means "including,
but not limited to." Those familiar with the art may recognize
other equivalents to the specific embodiments described herein
which equivalents are also intended to be encompassed by the
claims.
[0065] Further, the particular features presented in the dependent
claims can be combined with each other in other manners within the
scope of the invention such that the invention should be recognized
as also specifically directed to other embodiments having any other
possible combination of the features of the dependent claims. For
instance, for purposes of claim publication, any dependent claim
which follows should be taken as alternatively written in a
multiple dependent form from all prior claims which possess all
antecedents referenced in such dependent claim if such multiple
dependent format is an accepted format within the jurisdiction
(e.g., each claim depending directly from claim 1 should be
alternatively taken as depending from all previous claims). In
jurisdictions where multiple dependent claim formats are
restricted, the following dependent claims should each be also
taken as alternatively written in each singly dependent claim
format which creates a dependency from a prior
antecedent-possessing claim other than the specific claim listed in
such dependent claim below (e.g., claim 3 may be taken as
alternatively dependent from claim 2; claim 5 may be taken as
alternatively dependent on claim 3, claim 6 may be taken as
alternatively dependent from claim 3; claim 7 may be taken as
alternatively dependent from claims 3, 5 or 6; etc.).
* * * * *