U.S. patent application number 11/402222 was filed with the patent office on 2007-01-18 for tool to direct bone graft.
This patent application is currently assigned to Spineology, Inc.. Invention is credited to James W. Ahern, John E. Kuslich, Stephen D. Kuslich, Francis Peterson.
Application Number | 20070016214 11/402222 |
Document ID | / |
Family ID | 24969226 |
Filed Date | 2007-01-18 |
United States Patent
Application |
20070016214 |
Kind Code |
A1 |
Kuslich; Stephen D. ; et
al. |
January 18, 2007 |
Tool to direct bone graft
Abstract
A tool for directing bone replacement material under pressure
comprising an elongated hollow tube having a proximal end, a distal
end, and a longitudinal axis; the distal end including at least one
opening having a deflection structure configured to deflect the
bone replacement material out of the tube at an angle relative to
the longitudinal axis of the tube in response to pressure applied
to the bone replacement material such that the deflected bone
replacement material creates a force with at least a portion of the
force generally oriented perpendicular to the longitudinal axis of
the tube.
Inventors: |
Kuslich; Stephen D.;
(Stillwater, MN) ; Peterson; Francis; (Prescott,
WI) ; Ahern; James W.; (Hopkins, 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: |
24969226 |
Appl. No.: |
11/402222 |
Filed: |
April 11, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
09738726 |
Dec 15, 2000 |
7025771 |
|
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11402222 |
Apr 11, 2006 |
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Current U.S.
Class: |
606/92 |
Current CPC
Class: |
A61B 17/7095 20130101;
A61F 2002/4635 20130101; A61F 2/442 20130101; A61B 17/7098
20130101; A61B 17/8811 20130101; A61F 2310/00293 20130101; A61B
17/7097 20130101; A61F 2002/2817 20130101; A61F 2002/4495 20130101;
A61F 2002/4627 20130101; A61F 2002/30057 20130101; A61F 2002/2835
20130101; A61F 2/441 20130101; A61F 2/4601 20130101; A61F 2/4611
20130101 |
Class at
Publication: |
606/092 |
International
Class: |
A61F 2/00 20060101
A61F002/00 |
Claims
1. A tool for directing bone replacement material under pressure
comprising: an elongated hollow tube having a proximal end, a
distal end and a longitudinal axis; the distal end including at
least one opening having a deflection structure configured to
deflect the bone replacement material out of the tube at an angle
relative to the longitudinal axis of the tube in response to
pressure applied to the bone replacement material such that the
deflected bone replacement material creates a force with at least a
portion of the force generally oriented perpendicular to the
longitudinal axis of the tube.
2. A tool for directing bone replacement material under pressure
comprising: an elongated hollow tube having a proximal end, a
distal end and a longitudinal axis; the distal end including at
least one means for deflecting the bone replacement material out of
the tube at an angle relative to the longitudinal axis of the tube
in response to pressure applied to the bone replacement material
such that the deflected bone replacement material creates a force
with at least a portion of the force generally oriented
perpendicular to the longitudinal axis of the tube.
3. A tool for directing bone replacement material under pressure
comprising: an elongated tube having a proximal end, a distal end
and a longitudinal axis; the tube filled with bone replacement
material creating a columnar configuration of the bone replacement
material in the tube in response to pressure applied to the
proximal end of the tube; the distal end of the tube including at
least one opening having a cantilevered deflection structure
configured to deflect bone replacement material out of the tube at
an angle relative to the longitudinal axis of the tube in response
to pressure applied to the bone replacement material such that the
cantilevered deflection structure creates a force that breaks up
the columnar configuration of the bone replacement material when
the bone replacement material is pushed against the cantilevered
deflection structure.
4. A tool for directing bone replacement material under pressure
comprising: an elongated hollow tube having a proximal end, a
distal end and a longitudinal axis; the tube filled with bone
replacement material creating a columnar configuration of the bone
replacement material in the tube in response to pressure applied to
the proximal end of the tube; the distal end including at least one
means for deflection of the bone replacement material out of the
tube at an angle relative to the longitudinal axis of the tube in
response to pressure applied to the bone replacement material such
that the means for deflection creates a force that breaks up the
columnar configuration of the bone replacement material when the
bone replacement material is pushed against the means for
deflection.
5. A method of directing bone replacement material under pressure
into a cavity comprising the steps of: (a) providing an elongated
hollow tube having a proximal end, a distal end and a longitudinal
axis, the distal end including at least one opening having a
deflection structure; (b) positioning the distal end into a first
position in the cavity; (c) applying pressure to the bone
replacement material; (d) deflecting the bone replacement material
out of the tube into the cavity at an angle relative to the
longitudinal axis of the tube; (e) selectively orienting the distal
end of the tube to a second position in the cavity to guide and
deflect the bone replacement material; (f) applying pressure to the
bone replacement material; (g) deflecting the bone replacement
material out of the tube into the cavity at an angle relative to
the longitudinal axis of the tube.
6. The method of claim 5 further including the step of: repeating
steps (e)-(g) until the desired amount of bone replacement material
is delivered.
Description
RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 09/608,079, filed Jun. 30, 2000, which is a
continuation of U.S. patent application Ser. No. 09/738,726, filed
Dec. 15, 2000, now U.S. Pat. No. 7,025,771, issued Apr. 11,
2006.
BACKGROUND OF THE INVENTION
[0002] This invention relates to a tool for use injecting bone
replacement material into a cavity within a bone, especially when
the cavity includes a bag which is to be inflated within the
cavity.
[0003] U.S. Pat. No. 5,549,679 issued Aug. 20, 1996 and U.S. Pat.
No. 5,571,189 which issued Nov. 5, 1996 disclose an expandable
fabric bag and method for stabilizing a spinal motion segment. In
those patents, a damaged disc is reamed out and an expandable
fabric bag is inserted into the cavity thus formed. Bone graft
material is then inserted into the bag to fill and expand the bag
such that the filled bag will take the place of the reamed out
disc. Over time, the material within the bag will cause
stabilization by either fibrous or bony fusion or a combination of
these between the adjacent vertebrae. The bag filling is through an
opening which is closed off after filling.
[0004] 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.
BRIEF SUMMARY OF THE INVENTION
[0005] The invention provides a tool which dramatically increases
the distraction forces within an expandable fabric bag held within
a reamed out disc. Distraction consists of a force that is
perpendicular to the long axis of the injection tube, thereby
producing distraction or increased separation distance between the
bony structures that are perpendicular to the long axis of the
injection tube. This allows the spacing between the vertebrae to be
adjusted by inflating the bag as desired. The tool may be used in
connection with any surgical application in which graft material is
to be deployed and is not limited to use in connection with discs
or where bags are required.
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] A detailed description of the invention is hereafter
described with specific reference being made to the drawings in
which:
[0007] FIG. 1 is a perspective view of a distal end of a filling
tool of the invention;
[0008] FIG. 2 is a side elevational view of the distal end of the
tool of FIG. 1;
[0009] FIG. 3 is a cross-sectional view of the distal end of the
filling tool of the invention showing bone material
therewithin;
[0010] FIG. 4 is a cross-sectional view of a bag to be filled
showing the filling tool inserted into the bag opening;
[0011] FIG. 5 is a perspective view of a distal end of an alternate
filling tool of the invention;
[0012] FIG. 6 is a side elevational view of the distal end of the
tool of FIG. 5;
[0013] FIG. 7 is a top view of the opening at the distal end of the
tool of FIG. 5;
[0014] FIG. 8 is a representation of the effects of temperature
change on the filled tubes of the invention showing a filled tube
in cross-section;
[0015] FIG. 9 is a perspective view of a graft insertion tool
suitable for use with inserting a band;
[0016] FIG. 10 is a side view of the tool shown in FIG. 9;
[0017] FIG. 11 is a top down view of the tool of FIG. 9;
[0018] FIG. 12 is a side view of the tool of FIG. 9 seen
dislocating the fibers of a band; and
[0019] FIG. 13 is a top down cut away view of the tool of FIG. 9 as
may be seen during graft insertion.
DETAILED DESCRIPTION OF THE INVENTION
[0020] U.S. Pat. Nos. 5,571,189 and 5,549,679 are incorporated
herein by reference. They show an expandable fabric bag which is to
be inflated within a reamed out disc space by introduction of bone
replacement material through the bag opening. As shown in FIG. 4,
bag 10 of the patents is a fabric bag having an opening 12. The
opening 12 may be closed off by any number of methods. It has been
found that insertion of the bone graft material into the bag may
result in low distraction forces and may allow the fill tube to be
blown back out of the bag opening when fill pressure is
increased.
[0021] The bone replacement material might be one or more of the
following, or any other biocompatible material judged to have the
desired physiologic response: [0022] A) Morselized bone graft,
cortical, cancellous, or cortico-cancellous, including autograft,
allograft, or xenograft. [0023] 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:
[0024] Hydroxyapatite
[0025] Bone morphogenic protein
[0026] Calcified or decalcified bone derivative [0027] C) Bone
cements, such as ceramic and polymethylmethacrylate bone
cements.
[0028] The inventive fill tool 18 of FIGS. 1-4 involves an
elongated hollow tube 20 having a proximal end which is attached to
a source of bone replacement material under pressure and a distal
end 22 which includes the inventive features. As seen, the distal
end 22 includes a deflector 24 which deflects flow of bone
replacement material 26 out the side openings 30, 32 at an angle.
One or more side openings 30, 32 may be present. The deflector 24
as shown in FIG. 3 includes two side openings 30, 32 and the
deflector is basically a tapered wedge which diverts flow outwardly
to both sides. If only a single side opening is present, the
deflector would deflect all flow to that side opening.
[0029] As shown in FIG. 4, a single side opening 30 allows
deflection of the bone replacement material into the expandable
fabric bag 10 at an angle relative to the longitudinal axis of the
filling tool such that internal forces building up within the bag
do not cause the tool 18 to be ejected out along its longitudinal
axis. Rather, any forces inside the bag are exerted back on the
sides of the tool 18 against the side walls of the bag, preventing
ejection of the tool 18 and allowing more pressure to be applied
within the bag 10.
[0030] The forces during filling provided by the device are
perpendicular to the axis of the tube to stop tear through, to
prevent the tube from being pushed out during filling, to direct
the flow to get the distraction desired and to reduce the overall
forces required. A straight tube with an open end has no
distraction forces perpendicular to the tube and merely lays a long
column of replacement material that needs to buckle before more
material can be extruded from the tube. The inventive device breaks
up the column of replacement material in the tube by cantilever
forces. A straight tube with an open end creates a rigid bar of
replacement material that can break a containment bag or damage
body structures they press against or cause the tube to be ejected
from the neck of the bag or body cavity opening.
[0031] FIGS. 5-7 show an alternative fill tube 40 having a single
side opening 30. As shown, the apex 42 is partially closed and the
tube is angled toward the apex 42 to help guide and direct the
material within the tube out to the side opening 30.
[0032] Tests show a dramatic increase in distraction forces for
filling a bag with a tool of the invention in comparison to a fill
tool which has an opening in line with its longitudinal axis. Since
bone replacement material tends to become quite rigid under
pressure, injection of bone replacement material into the bag at an
angle relative to the longitudinal axis of the fill tube allows the
bag to inflate and create forces which are not directed to eject
the fill tool.
[0033] If the internal diameter of the tube is D, the length of the
side opening 30 is preferably between about 11/2 to 3D. If the side
opening 30 length is only 1D or smaller, harder pushing is required
and packing of the material may result in the tube. The distal end
of the tube 40 towards the apex 42 is also preferably angled to
direct the flow and to break down any material that has packed back
into more discrete pieces. The end adjacent the apex 42 of the tool
may be completely closed or open up to 1/2D which still provides
good side direction of product.
[0034] FIG. 8 depicts a filled tube 20, 40 of the invention which
has been filled with bone replacement material 26. The invention
contemplates cooling the tubes prior to use and warming them just
prior to use such that expansion of the metal tube causes expansion
to help decrease friction to the tube. In addition, if thawing
occurs at the metal interface with the bone replacement material, a
liquid layer will be formed to lubricate the replacement material
within the tube. This allows easier egress of material within the
tube.
[0035] As may be seen in FIG. 9, the tool may also be used to
insert a single walled band into a cavity formed in a spinal disc
as disclosed in co-pending U.S. patent application entitled
Expandable Tube for Spinal Stabilization, to Kuslich, and is filed
concurrently herewith. The entire contents of the aforementioned
concurrently filed application is incorporated herein by reference.
As shown in FIG. 12 and 13, the band 50 is shown with a graft
insertion tool 60 being inserted into the interior 52 of the band
50 by passing through one of the spaces or pores 54. The shape of
the tool 60 as may best be seen in FIGS. 9-11 is essentially an
elongate shaft 62 having a tapered or pointed distal end 64.
[0036] The tapered distal end 64 of the tool 60 is sized to enlarge
the opening 54 to allow passage of the tool 60 into the interior 52
by pushing aside the various fibers 56 as may best be seen in FIG.
12. The fibers 56 are disposed to open the pore 54 from its nominal
diameter of 0.25 to 5 mm to an enlarged opening sufficient to allow
passage of a portion of the shaft 62 therethrough
[0037] The extent of tool penetration into the band interior 52
must be sufficient to allow the side opening 66 to be fully
contained within the band interior 52. The tool 60 may include more
than one side opening 66.
[0038] As shown in FIG. 13, the side opening 66 allows insertion of
the bone graft material into the band interior 52. The tool 60
includes a means for pushing graft material from within the shaft
62, through the side opening 66 and into the band interior 52.
[0039] While this invention may be embodied in many different
forms, there are shown in the drawings and described in detail
herein specific preferred embodiments of the invention. The present
disclosure is an exemplification of the principles of the invention
and is not intended to limit the invention to the particular
embodiments illustrated. For example, the inventive device and
methods may be used whenever replacement material needs to be
directed into a defined location and not just when a bag is to be
filled within a disc cavity.
[0040] This completes the description of the preferred and
alternate embodiments of the invention. Those skilled in the art
may recognize other equivalents to the specific embodiment
described herein which equivalents are intended to be encompassed
by the claims attached hereto.
* * * * *