U.S. patent application number 13/195483 was filed with the patent office on 2011-11-24 for device and method for distraction of the spinal disc space.
This patent application is currently assigned to Crosstrees Medical, Inc.. Invention is credited to Kwan Ku Lin, Robert M. Scribner, Philip S. Yuan.
Application Number | 20110288530 13/195483 |
Document ID | / |
Family ID | 36036876 |
Filed Date | 2011-11-24 |
United States Patent
Application |
20110288530 |
Kind Code |
A1 |
Yuan; Philip S. ; et
al. |
November 24, 2011 |
DEVICE AND METHOD FOR DISTRACTION OF THE SPINAL DISC SPACE
Abstract
An extractable device is used to insert a medicinal filling into
a spinal disc. The device comprises a filling member and a flowable
medicine. The filling member is made of a flexible and permeable
wall and is provided with a holding portion and an injection port
via which the flowable medicine is injected into the holding
portion after the filling member is inserted into the spinal disc.
The holding portion is provided with an opening which is releasably
lashed by one end of one or more threads so as to make the opening
leakproof. Upon completion of solidification of the flowable
medicine in the holding portion of the filling member, other end of
the thread is pulled to unlash the opening of the holding portion,
thereby enabling the filling member to be extracted from the spinal
disc so as to leave only the medicine in the spinal disc.
Inventors: |
Yuan; Philip S.; (Long
Beach, CA) ; Lin; Kwan Ku; (San Marino, CA) ;
Scribner; Robert M.; (Niwot, CO) |
Assignee: |
Crosstrees Medical, Inc.
Boulder
CO
|
Family ID: |
36036876 |
Appl. No.: |
13/195483 |
Filed: |
August 1, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12829500 |
Jul 2, 2010 |
7993345 |
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13195483 |
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11574562 |
Mar 1, 2007 |
7749230 |
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PCT/US05/31356 |
Sep 2, 2005 |
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12829500 |
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60606611 |
Sep 2, 2004 |
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Current U.S.
Class: |
604/513 ;
604/288.01 |
Current CPC
Class: |
A61F 2002/444 20130101;
A61F 2/441 20130101; A61F 2002/30677 20130101; A61F 2/442
20130101 |
Class at
Publication: |
604/513 ;
604/288.01 |
International
Class: |
A61M 5/00 20060101
A61M005/00 |
Foreign Application Data
Date |
Code |
Application Number |
Sep 2, 2005 |
US |
PCT/US2005/031356 |
Claims
1. An extractable device for inserting a medicinal filling into a
spinal disc, said device comprising: a filling member comprising a
flexible wall and provided with a holding portion, an injection
port at one end of the holding portion, and an opening at another
end of the holding portion; one or more thread fastening releasably
said opening of said holding portion in such a manner that said
opening is leakproof; and a flowable medicine to be injected into
said holding portion via said injection port of said filling member
in the wake of a process for inserting said filling member into the
spinal disc; said opening of said holding portion being opened,
thereby enabling said filling member to be extracted from the
spinal disc so as to leave only said medicine in the spinal
disc.
2. The device as defined in claim 1, wherein said flexible wall is
provided with a plurality of through holes and is permeable.
3. The device as defined in claim 2, wherein said flexible and
permeable wall is of a one-layered or multi-layered
construction.
4. The device as defined in claim 1, wherein said flowable material
is a polymer capable of setting to a non-viscous state.
5. The device as defined in claim 1 further comprising an injection
tool for injecting said flowable medicine into said holding portion
via said injection port.
6. The device as defined in claim 5, wherein said injection tool
comprises a guide tube and a syringe, wherein one end of said guide
tube is connected to said injection port of said filling member and
another end of said guide tube is connected to said syringe in
which said flowable medicine is held, so that said flowable
medicine is able to be injected into said holding portion of said
filling member by said syringe via said injection port and said
guide tube.
7. The device as defined in claim 6 further comprising a working
tube for inserting into said spinal disc, so that said filling
member together with said guide tube can be inserted into said
working tube and said filling member can be disposed in said spinal
disc.
8. The device as defined in claim 3, wherein said tubular wall is
provided with a plurality of through holes and is permeable.
9. A method for implanting a solidified medicine into a spinal disc
comprising: inserting a filling member in a hole of a spinal disc,
said filling member comprising a flexible and permeable wall and
provided with a holding portion, an injection port at one end of
the holding portion, and an opening at another end of the holding
portion, wherein one or more thread is provided and each having one
end fastening releasably said opening of said holding portion in
such a manner that said opening is leakproof, wherein said holding
portion of said filling member is inflatable; injecting a flowable
medicine into said holding portion via said injection port of said
filling member, so that said holding portion is inflated and said
flowable medicine solidifies in said holding portion of said
filling member; and unfastening said opening of said holding
portion by pulling other end of said threads, thereby enabling said
filling member to be extracted from the spinal disc so as to leave
only said solidified medicine in the spinal disc, wherein said
solidified flowable medicine has a shape similar to that of the
inflated holding portion.
10. The method as defined in claim 9, wherein said flowable
material is a polymer capable of setting to a non-viscous
state.
11. The method as defined in claim 9 further comprising fastening
detachably an injection tool with said filling member, so that said
flowable medicine is injected into said holding portion via said
injection tool.
12. The method as defined in claim 11, wherein said injection tool
comprises a guide tube and a syringe, wherein one end of said guide
tube is connected to said injection port of said filling member and
another end of said guide tube is connected to said syringe in
which said flowable medicine is held, wherein said flowable
medicine is injected into said holding portion of said filling
member by said syringe via said injection port and said guide
tube.
13. The method as defined in claim 12 further comprising inserting
a working tube in said hole of said spinal disc, and inserting said
filling member together with said guide tube into said working
tube, so that said filling member is disposed in said spinal disc.
Description
FIELD OF THE INVENTION
[0001] The present invention relates generally to an instrument
which is used in the restorative surgical treatment of spine
disorder. More specifically this surgical instrument can be used to
insert a medical material into a spinal disc such that the
instrument can be separated from the medical material and drawn out
of the spinal disc, and the medical material remains in the spinal
disc in a restorative function.
BACKGROUND OF THE INVENTION
[0002] The surgical treatment of spinal disc disorder can be
generally attained by several methods, which include the hypodermic
injection of medicine, the balloon-insertion of medicine, and the
filler-insertion of medicine. For example, the U.S. Pat. Nos.
5,976,186, 6,508,839, and 6,602,291 disclose respectively methods
for treating disorders of the spinal disc, such as placement of a
prosthetic device or reconstruction of the damaged structure of the
disc. These methods are defective in design in that disc disruption
is required for placement of the therapeutic implant. The placement
of a therapeutic implant by controlled delivery of a flowable
material requiring minimal disruption of the disc is desirable.
Without controlled delivery, the medicine is not contained and
there is the possibility of injury to the surrounding tissues.
[0003] In order to prevent the drawbacks of the methods described
above, the filler-insertion method is used to implant material in
the spinal disc in such a way that the material is contained in the
spinal disc, and that the material only remains implanted in the
spinal disc.
SUMMARY OF THE INVENTION
[0004] An extractable device for inserting a medicinal filling into
a spinal disc, said device comprising:
[0005] a filling member comprising a flexible wall and provided
with a holding portion, an injection port at one end of the holding
portion, and an opening at another end of the holding portion;
[0006] one or more thread, each having one end for fastening
releasably said opening of said holding portion in such a manner
that said opening is leakproof; and
[0007] a flowable medicine to be injected into said holding portion
via said injection port of said filling member in the wake of a
process for inserting said filling member into the spinal disc
whereby said flowable medicine solidifies in said holding portion
of said filling member;
[0008] said opening of said holding portion being unfastened at the
time when other end of said threads is pulled by an external force,
thereby enabling said filling member to be extracted from the
spinal disc so as to leave only said flowable material in the
spinal disc;
[0009] wherein the volume of said holding portion of said filling
member is filled and is substantially tubular after being filled,
wherein cross sections perpendicular to a longitudinal axis of the
holding portion are substantially elliptical along a direction from
the injection port to the opening of the holding portion.
[0010] Preferably, said flexible wall is provided with a plurality
of through holes and is permeable. Said flexible and permeable wall
is of a one-layered or multi-layered construction.
[0011] Preferably, said flowable medicine is a polymer substance
such as a mixture which is flowable prior to setting to a
non-viscous state such as PMMA, silicone, polyurethane, polyester,
or other polymer.
[0012] Preferably, the device of the present invention further
comprises an injection tool for injecting said flowable medicine
into said holding portion via said injection port.
[0013] Preferably, said injection tool comprises a guide tube and a
syringe, wherein one end of said guide tube is connected to said
injection port of said filling member and another end of said guide
tube is connected to said syringe in which said flowable medicine
is held, so that said flowable medicine is able to be injected into
said holding portion of said filling member by said syringe via
said injection port and said guide tube.
[0014] Preferably, the device of the present invention further
comprises a working tube for inserting into said spinal disc, so
that said filling member together with said guide tube can be
inserted into said working tube and said filling member can be
disposed in said spinal disc.
[0015] Preferably, said tubular wall is provided with a plurality
of through holes and is permeable.
[0016] The present invention also discloses a method for implanting
a solidified medicine into a spinal disc comprising:
[0017] inserting a filling member in a hole of a spinal disc, said
filling member comprising a flexible and permeable wall and
provided with a holding portion, an injection port at one end of
the holding portion, and an opening at another end of the holding
portion, wherein one or more thread is provided and each having one
end fastening releasably said opening of said holding portion in
such a manner that said opening is leakproof, wherein said holding
portion of said filling member is substantially tubular after being
filled, wherein cross sections perpendicular to a longitudinal axis
of the holding portion are substantially elliptical along a
direction from the injection port to the opening of the holding
portion;
[0018] injecting a flowable medicine into said holding portion via
said injection port of said filling member, so that said holding
portion is inflated and said flowable medicine solidifies in said
holding portion of said filling member; and
[0019] unfastening said opening of said holding portion by pulling
other end of said threads, thereby enabling said filling member to
be extracted from the spinal disc so as to leave only said
solidified medicine in the spinal disc,
[0020] wherein said solidified flowable medicine has a shape
similar to that of the inflated holding portion.
[0021] Preferably, the method of the present invention further
comprises fastening detachably an injection tool with said filling
member, so that said flowable medicine is injected into said
holding portion via said injection tool. More preferably, said
injection tool comprises a guide tube and a syringe, wherein one
end of said guide tube is connected to said injection port of said
filling member and another end of said guide tube is connected to
said syringe in which said flowable medicine is held, wherein said
flowable medicine is injected into said holding portion of said
filling member by said syringe via said injection port and said
guide tube.
[0022] Preferably, the method of the present invention further
comprises inserting a working tube in said hole of said spinal
disc, and inserting said filling member together with said guide
tube into said working tube, so that said filling member is
disposed in said spinal disc.
[0023] The flexible wall of the filling member of the present
invention is made of a biocompatible or biosynthetic material, such
as polymer, rubber, elastic plastic, PTFE, Dacron, and like
materials. The flexible wall is provided with a plurality of pores
and is therefore permeable. Pores may be provided by fabricating
the wall from a weave of selected material, or by perforation of a
film of selected material. The flexible wall can be formed into an
object in the form of sac, bag, ball, cylinder or rectangular
column integrally or by joining separate pieces.
[0024] The filling member of the present invention may contain a
radiopaque material, such as a metal wire, by which the precise
position of the filling member can be easily located by an imaging
system, such as X-ray imaging equipment.
[0025] The flexible wall of the filling member of the present
invention may be of a one-layered or multi-layered construction,
depending on the particle size and the viscosity of the medicine.
If the particle size of the medicine is relatively large, the
flexible wall is preferably of a two-layered construction. If the
viscosity of the medicine is relatively high, the flexible wall is
also preferably of a two-layered construction. On the other hand,
the flexible wall is preferably of a three-layered or four-layered
construction under the circumstances that the particle size of the
medicine is relatively small and that the viscosity of the medicine
is relatively lower.
[0026] The features and the advantages of the present invention
will be more readily understood upon a thoughtful deliberation of
the following detailed description of the preferred embodiments of
the present invention with reference to the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0027] FIG. 1 shows a schematic view of an extractable filler of
the present invention.
[0028] FIG. 2 is schematic view illustrating the lashing of the
opening of the holding portion of the filling member of the present
invention.
[0029] FIG. 3a shows a longitudinal sectional view of a one-layered
wall of the filling member of the present invention.
[0030] FIG. 3b shows a longitudinal sectional view of a
multi-layered wall of the filling member of the present
invention.
[0031] FIG. 4a shows a sectional view of the filling member placed
within the spinal disc.
[0032] FIG. 4b shows a sectional view of the filling member placed
within the spinal disc containing a full volume of flowable
material.
[0033] FIG. 5a shows a sectional view of the filling member with
the said opening in the open condition.
[0034] FIG. 5b is a sectional view showing the removal of the
filling member from the spinal disc.
[0035] FIG. 6a is a sectional view showing the flowable material
within the spinal disc.
[0036] FIG. 6b is a sectional view showing the flowable material at
more than one location within the spinal disc.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0037] As shown in FIG. 1, an extractable filler 10 embodied in the
present invention comprises a filling member 20, a flowable
medicine 30, a guide tube 40, and two threads 50 and 51. The
filling member 20 is formed of a flexible wall 21 and is provided
with a holding portion 22 and an injection port 23. The flexible
wall 21 may be made of rubber or a flexible plastic material with
perforated holes, or a woven fabric. The flowable medicine 30 is
injected into the holding portion 22 via the guide tube 40 and the
injection port 23. The dotted line 3-3 shows a direction in which a
section of the filling member 20 is taken.
[0038] As shown in FIG. 2, the holding portion 22 of the filling
member 20 is provided with an opening 24 opposite to the injection
port 23 of the filling member 40. The opening 24 is lashed by two
threads 50 and 51. The first thread 50 has a first end 501 and a
second end 502, while the second thread 51 has a first end 511 and
a second end 512. The two threads 50 and 51 are in fact fastened
releasably to the flexible wall 21 near the opening 24. The way by
which they are fastened together is not shown in the drawing.
[0039] The opening 24 of the holding portion 22 of the filling
member 20 is securely tied up to prevent the medicine 30 from
leaking out of the holding portion 22 by means of the two threads
50 and 51 which are releasably entangled in such a manner that the
first end 511 of the second thread 51 is wound around the first
thread 50. Upon completion of the winding process, the flexible
wall 21 surrounding the opening 24 is located in a position between
the two threads 50 and 51. Thereafter, both ends 501 and 502 of the
first thread 50, and the first end 511 of the second thread 51 are
respectively pulled rightward and leftwards at the same time, as
illustrated in FIG. 2. As a result, the opening 24 of the filling
member 20 is leakproof. The opening 24 of the filling member 20 is
untied when the second end 512 of the second thread 51 is pulled in
the direction of the injection port 23. As a result, the two
threads 50 and 51 become loosened. Thereafter, the first end 501 of
the first thread 50 and the second end 512 of the second thread 51
are respectively pulled in a direction away from the opening 24 of
the filling member 20, as illustrated in FIG. 5a. The opening 24 is
thus unfastened completely.
[0040] The flexible wall 21 of the filling member 20 is of a
one-layered construction, as shown in FIG. 3a, or of a
multi-layered construction, as shown in FIG. 3b. The flexible wall
21 is provided with a plurality of pores 211 permeable to fluids.
If the flexible wall 21 is of a multi-layered construction, the
flexible walls 21 are laminated in such a way that the pores 211
are not corresponding in location to slow down the passage of the
fluids.
[0041] As shown in FIG. 4a, the filling member 20 of the
extractable filler 10 is inserted into a hole 71 formed on a spinal
disc 70, wherein a working tube 51 is inserted into the hole 71 in
advance to accommodate the guide tube 40, the threads 50 and 51 and
the filling member 20. The flowable medicine is then injected into
the holding portion 21 of the filling member 20 by a syringe in
conjunction with the guide tube 40. The guide tube 40 has one end
41 in the holding portion 21, and another end 42 connected to one
end 611 of a barrel 612 of the syringe 80. A plunger 62 is inserted
into another end of the barrel 612 in which the pasty medicine 30
is contained. The filling member 20 is thus inflated by the
medicine 30, as shown in FIGS. 4a and 4b.
[0042] Preferably, said flowable medicine 30 is a polymer substance
such as a mixture which is flowable prior to setting to a
non-viscous state such as PMMA, silicone, polyurethane, polyester,
or other polymer.
[0043] Upon completion of the solidification of the pasty medicine
30 in the filling member 20 within the spinal disc 70, the filling
member 20 must be extracted from the hole 71 of the spinal disc 70,
so as to leave only the medicine 30 in the spinal disc 70. The
extraction of the filling member 20 from the hole 71 of the spinal
disc 70 involves a first step in which the second end 512 of the
second thread 51 is pulled in the direction of the filler opening
23. As a result, the two threads 50 and 51 become loosened.
Thereafter, the first end 501 of the first thread 50 and the second
end 512 of the second thread 51 are respectively pulled in a
direction away from the opening 24 of the filling member 20, as
illustrated in FIG. 5a. The opening 24 is thus unfastened
completely.
[0044] After the opening 24 being unfastened, the flexible wall 21
is retreated from the solidified medicine 30 by pulling one end of
the flexible wall 21 connected to the guide tube 40 at the
injection port 23 of said holding portion of the said filling
member 20, whereby said solidified medicine 30 is released from
said filling member 20 and is disposed in the spinal disc 70, as
shown in FIG. 5b. The filling member and the guide tube 40 are
pulled from the hole 71 of the spinal disc 70, so as to leave only
said solidified medicine 30 in the spinal disc 70.
[0045] The flexible wall 21 of the filling member 20 of the
extractable filler 10 of the present invention may have a curved
profile. As shown in FIG. 6a, the flowable material 30 injected
into the filling member 20 in the spinal disc 70 will also have a
curved profile when remaining within the spinal disc 70.
[0046] As shown in FIG. 6b, the filling member 20 may be placed at
more than one location in the spinal disc, with the flowable
material 30 remaining at more than one location in the spinal disc
70.
[0047] The above embodiments are, in all respects, illustrative and
nonrestrictive. The invention may be embodied in other specific
forms without deviating from the scope of the following claims.
* * * * *