U.S. patent application number 13/196221 was filed with the patent office on 2011-11-24 for extractable filler for inserting medicine into vertebral body.
This patent application is currently assigned to Crosstrees Medical, Inc.. Invention is credited to Kuan Ku Lin, Philip S. Yuan.
Application Number | 20110288528 13/196221 |
Document ID | / |
Family ID | 34699287 |
Filed Date | 2011-11-24 |
United States Patent
Application |
20110288528 |
Kind Code |
A1 |
Lin; Kuan Ku ; et
al. |
November 24, 2011 |
EXTRACTABLE FILLER FOR INSERTING MEDICINE INTO VERTEBRAL BODY
Abstract
An extractable device is used to insert a medicinal filling into
a vertebral body. The device comprises a filling member and a pasty
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 pasty medicine is injected into the holding portion
after the filling member is inserted into the vertebral body. 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 pasty 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
vertebral body so as to leave only the medicine in the vertebral
body.
Inventors: |
Lin; Kuan Ku; (San Marino,
CA) ; Yuan; Philip S.; (Long Beach, CA) |
Assignee: |
Crosstrees Medical, Inc.
Boulder
CO
|
Family ID: |
34699287 |
Appl. No.: |
13/196221 |
Filed: |
August 2, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11674088 |
Feb 12, 2007 |
7993343 |
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13196221 |
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10949217 |
Sep 27, 2004 |
7175629 |
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11674088 |
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Current U.S.
Class: |
604/506 ;
604/500; 604/96.01 |
Current CPC
Class: |
A61B 17/7098 20130101;
A61B 17/8855 20130101; A61B 17/3468 20130101; A61M 31/00 20130101;
A61B 17/3431 20130101; A61B 17/8811 20130101 |
Class at
Publication: |
604/506 ;
604/96.01; 604/500 |
International
Class: |
A61M 5/00 20060101
A61M005/00 |
Foreign Application Data
Date |
Code |
Application Number |
Sep 29, 2003 |
TW |
92126916 |
Claims
1. An extractable device for inserting a solidifiable medicinal
filling into an animal tissue, comprising: a flexible container
having a proximal injection port for injection of the filling into
the container, and a releasably closable distal opening for
delivery of the filling into the animal tissue outside of the
container; and at least one releasable thread that releasably
closes the distal opening to contain the filling within the
container prior to solidification, and that reopens the distal
opening to enable the delivery of the filling into the animal
tissue outside of the container after solidification; in which the
container is inflatable and, after being inflated, is substantially
tubular with cross sectional areas that increase from the injection
port to the distal opening.
2. The device of claim 1, in which the flexible container is
permeable.
3. The device of claim 1, in which the flexible container is
hermetic.
4. The device of claim 1, in which the thread is releasable upon
application of an external pulling force.
5. The device of claim 1, in which the thread is releasable upon
application of an external pushing force.
6. The device of claim 1, in which the container comprises a
single-layered wall.
7. The device of claim 1, in which the container comprises a
multi-layered wall.
8. The device of claim 1, in which the container comprises inner
and outer layers.
9. The device of claim 1, further comprising means for injecting
the solidifiable medicinal filling into the device through the
injection port.
10. The device of claim 1, in which the permeable container is
formed of a plurality of threads.
11. The device of claim 1, in which the permeable container is
formed of a plurality of threads by weaving.
12. In combination, the device of claim 1 and an injection tool for
injecting the solidifiable medicinal filling into the device
through the injection port.
13. The combination of claim 12, in which the injection tool
comprises a guide tube connected to the injection port.
14. The device of claim 1, in which the container comprises a
folded double-layer tubular wall having a proximal inner layer end
and a distal folded double-layer end, in which the delivery of the
filling follows pulling a free end of an outer layer of the
double-layer tubular wall to retreat the folded double-layer end,
after the opening end of the holding portion has been reopened.
15. The device of claim 14, in which at least one releasable thread
is between an inner layer and the outer layer of the double-layer
tubular wall.
16. The device of claim 14, in which the inner layer and the outer
layer of the double-layer tubular wall are provided with a
plurality of through holes and are permeable.
17. A method for implanting a solidified medicine into an animal
tissue, comprising: inserting into the animal tissue a flexible
container having a distal opening that is releasably closable; at
least partially filling the container with a solidifiable medicinal
filling; solidifying the medicinal filling within the container;
reopening the distal opening of the container; and depositing the
filling into the animal tissue through the distal opening by
extracting the container from the animal tissue; in which the
container is inflatable and, after being inflated, is substantially
tubular with cross sectional areas that increase from the injection
port to the distal opening.
18. The method of claim 17, further comprising injecting the
filling into the container through an injection port on a proximal
end of the container.
19. An extractable device for placing a solidifiable medicinal
filling into an animal tissue, comprising: a flexible container,
comprising a proximal inlet for receipt of the filling and a
releasably closable distal outlet for subsequent delivery of
solidified filling into the animal tissue; at least one releasable
thread to reduce leakage of the filling from the container; in
which the container is inflatable and, after being inflated, is
substantially tubular with cross sectional areas that increase from
the injection port to the distal opening.
20. A method for placing a solidified medicine into an animal
tissue, comprising: inserting into the animal tissue a flexible
container having a proximal inlet and a distal, releasably
leakproof outlet, providing the container with a solidifiable
medicinal filling through the proximal inlet; solidifying the
filling within the container; reopening the distal outlet;
delivering the solidified filling into the animal tissue through
the distal outlet opening; and removing the container from the
animal tissue; in which the container is inflatable and, after
being inflated, is substantially tubular with cross sectional areas
that increase from the injection port to the distal opening.
Description
FIELD OF THE INVENTION
[0001] The present invention relates generally to an instrument
which is used in the restorative operation of vertebral body
disorder. More specifically this surgical instrument can be used to
insert a medical material into a vertebral body such that the
instrument can be separated from the medical material and drawn out
of the vertebral body, and the medical material solidifies in the
vertebral body.
BACKGROUND OF THE INVENTION
[0002] The surgical treatment of vertebral body disorder can be
generally attained by one of three 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. 5,972,105; 6,066,154; and 6,248,110B1 disclose
respectively a method for treating bone tissue disorders, such as
osteoporosis and vertebral compression fractures. The method
involves the use of a balloon (made by the Kyphon Crop., U.S.A.) by
which the tissue is expanded to facilitate the inserting of the
medicine. This balloon method is defective in design in that the
medicine is apt to spread aimlessly in the tissue without boundary.
Without containment, the medicine is not as effective and there is
the possibility of injury to the surrounding tissues.
[0003] In order to prevent the drawbacks of the balloon method
described above, the filler-insertion method is used to implant the
medicine in vertebral body in such a way that the medicine is
contained in the filler, and that both the medicine and the filler
are implanted in the vertebral body. This filler-insertion method
is often carried out in danger of the tissue rejection of the
filler.
[0004] However, the aforesaid treatments do not focus on the
retrieval of original spinal curvature, where the front end of the
vertebra having vertebral compression fractures is relatively
insufficiently supported, and the patient is apt to regain the
vertebral collapse problem after the implantation surgery.
SUMMARY OF THE INVENTION
[0005] An extractable device for inserting a medicinal filling into
a vertebral body, said device comprising:
[0006] 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;
[0007] 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
[0008] a pasty 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 vertebral body
whereby said pasty medicine solidifies in said holding portion of
said filling member;
[0009] 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
vertebral body so as to leave only said medicine in the vertebral
body,
[0010] wherein said holding portion of said filling member is
inflatable and is substantially tubular after being inflated,
wherein cross sections perpendicular to a longitudinal axis of the
holding portion are substantially elliptical and have increasing
areas thereof along a direction from the injection port to the
opening of the holding portion.
[0011] 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.
[0012] Preferably, aid pasty medicine is a mixture of a liquid and
a medicinal powdered substance or medicinal granular substance.
[0013] Preferably, the device of the present invention further
comprises an injection tool for injecting said pasty medicine into
said holding portion via said injection port.
[0014] 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 pasty medicine is
held, so that said pasty 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.
[0015] Preferably, the device of the present invention further
comprises a working tube for inserting into said vertebral body, 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 vertebral body.
[0016] Preferably, said flexible wall is a folded double-layer
tubular wall having an inner layer end and a folded double-layer
end, wherein said injection port of said holding portion is
provided at said inner layer end, and said opening of said holding
portion is provided at said folded double-layer end, wherein said
medicine is released from said filling member by pulling a free end
of an outer layer of the double-layer tubular wall to retreat the
folded double-layer end, after said opening of said holding portion
being unfastened. More preferably, said one or more thread is
between an inner layer and said outer layer of said double-layer
tubular wall.
[0017] Preferably, said inner layer and said outer layer of said
double-layer tubular wall are provided with a plurality of through
holes and are permeable.
[0018] The present invention also discloses a method for implanting
a solidified medicine into a vertebral body comprising:
[0019] inserting a filling member in a hole of a vertebral body,
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 and is substantially
tubular after being inflated, wherein cross sections perpendicular
to a longitudinal axis of the holding portion are substantially
elliptical and have increasing areas thereof along a direction from
the injection port to the opening of the holding portion;
[0020] injecting a pasty medicine into said holding portion via
said injection port of said filling member, so that said holding
portion is inflated and said pasty medicine solidifies in said
holding portion of said filling member; and
[0021] unfastening said opening of said holding portion by pulling
other end of said threads, thereby enabling said filling member to
be extracted from the vertebral body so as to leave only said
solidified medicine in the vertebral body,
[0022] wherein said solidified pasty medicine has a shape similar
to that of the inflated holding portion, and a cross section having
a greater area of said solidified medicine is closer to a cortical
rim opposite to a pedicle of said vertebral body in comparison with
a cross section having a smaller area of said solidified
medicine.
[0023] Preferably, the method of the present invention further
comprises fastening detachably an injection tool with said filling
member, so that said pasty 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 pasty medicine is held, wherein said pasty
medicine is injected into said holding portion of said filling
member by said syringe via said injection port and said guide
tube.
[0024] Preferably, the method of the present invention further
comprises inserting a working tube in said hole of said vertebral
body, and inserting said filling member together with said guide
tube into said working tube, so that said filling member is
disposed in said vertebral body.
[0025] The flexible wall of the filling member of the present
invention is made of a biocompatible or biosynthetic material, such
as rubber, elastic plastic, titanium, goat intestine, and the like.
The flexible wall is provided with a plurality of pores and is
therefore permeable. 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.
[0026] The filling member of the present invention may contain a
ray imaging material, such as a metal wire, by which the precise
position of the filling member can be easily located by a ray
imaging system, such as an X-ray machine.
[0027] 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.
[0028] 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
[0029] FIG. 1 shows a schematic view of an extractable filler of
the present invention.
[0030] FIGS. 2a and 2b are schematic views illustrating the lashing
of the opening of the holding portion of the filling member of the
present invention.
[0031] FIG. 3a shows a longitudinal sectional view of a one-layered
wall of the filling member of the present invention.
[0032] FIG. 3b shows a longitudinal sectional view of a
multi-layered wall of the filling member of the present
invention.
[0033] FIGS. 4a and 4b are schematic views illustrating the
unlashing of the opening of the holding portion of the filling
member of the present invention upon completion of the injection of
the medicine into the holding portion of the filling member.
[0034] FIGS. 5a and 5b are schematic views illustrating a process
in which a double-layer wall of the holding portion of the filling
member of the present invention is formed.
[0035] FIG. 5c is a schematic view of the extractable filler shown
in FIGS. 5a and 5b after the double-layer wall of the holding
portion of the filling member is formed.
[0036] FIGS. 6a to 6c are sectional schematic views of the present
invention at work.
[0037] FIGS. 7a and 7b are sectional schematic views illustrating
the process in which the filling member of the present invention is
extracted from the vertebral body.
[0038] FIGS. 8a and 8b are schematic views illustrating that the
holding portion of the filling member of the present invention has
a curved profile.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0039] As shown in FIG. 1, an extractable filler 10 embodied in the
present invention comprises a filling member 20, a pasty 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 23 and an injection port 24. The flexible wall 21 may be
made of rubber or a flexible plastic material with perforated
holes. The pasty medicine 30 is injected into the holding portion
23 via the guide tube 40 and the injection port 24. The dotted line
3-3 shows a direction in which a section of the filling member 20
is taken. The holding portion 23 has a shape similar to a cone with
a longitudinal axis 201, wherein two cross sections 202 and 203
perpendicular to the longitudinal axis 201 are elliptical. The
cross section 202 has a short diameter 211 and a long diameter 221,
and the cross section 203 has a short diameter 212 and a long
diameter 222, wherein the short diameter 211 and the long diameter
221 are longer than the short diameter 212 and the long diameter
222, respectively. When the filling member 20 is inserted in a
collapsed vertical body, the cross section 202 is at a position
closer to a cortical rim opposite to a pedicle of said vertebral
body and the cross section 203 is at a position near to the
cortical rim close to the pedicle of said vertebral body.
Preferably, the long diameters 221 and 222 are in the same
direction of the vertebral column.
[0040] As shown in FIGS. 2a and 2b, the holding portion 23 of the
filling member 20 is provided with an opening 25 opposite to the
injection port 24 of the filling member 20. The opening 25 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 25. The way by which they are fastened together is not
shown in the drawing.
[0041] The opening 25 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 25 is located in a position between
the two threads 50 and 51, as indicated by a dotted line 4-4 in
FIG. 2a. 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. 2b. As a result, the opening 25 of the filling member 20 is
leakproof.
[0042] 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 213 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 213
are not corresponding in location to slow down the passage of the
fluids.
[0043] The opening 25 of the filling member 20 is untied when the
second end 512 of the second thread 51 is pulled upward as
indicated by an arrow in FIG. 4a. 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. 5b. The opening 25 is
thus unfastened completely.
[0044] A further embodiment of the present invention is shown in
FIGS. 5a, 5b and 5c, which is similar to the embodiment shown in
FIGS. 1 to 4b, except that a filling member 60 is formed of a
double-layer wall 61 and the first thread 51 and second thread 52
are located between an inner layer 612 and an outer layer 611 of
the double-layer wail 61. As shown in FIGS. 5a and 5b, a flexible
and permeable tubular wall having an injection port 64 at one end
is tied at an intermediate point thereof by the threads 50 and 51
at the beginning. The lower portion 611 of the tubular wall (will
become an outer layer) is then rolled up, so that it is inside out
and covering up the threads 50 and 51 and the upper portion 612 of
the tubular wall (will become an inner layer). The rolled-up end of
said double-layer wall 61 is provided with an opening 52 of the
holding portion 63, which is lashed by the two threads 50 and 51.
The holding portion 63 as shown in FIG. 5c has a conic shape
similar to the embodiment shown in FIG. 1. The opening 65 can be
unfastened by pulling the threads 50 and 51 the same way as shown
in FIGS. 4a and 4b.
[0045] As shown in FIGS. 6a to 6c, the filling member 60 of the
extractable filler 10 is inserted into a hole 81 formed on a
vertebral body 80, wherein a working tube 43 is inserted into the
hole 81 in advance to accommodate the guide tube 40, the threads 50
and 51 and the free end of the outer layer 611 of the double-layer
wall 61 of the filling member 60. The pasty medicine 30 is then
injected into the holding portion 63 of the filling member 60 by a
syringe 70 in conjunction with the guide tube 40. The guide tube 40
has one end 41 in the holding portion 63, and another end 42
connected to one end 711 of a barrel 71 of the syringe 70. A
plunger 72 is slidably inserted into another end 712 of the barrel
61 in which the pasty medicine 30 is contained. The filling member
60 is thus inflated by the medicine 30, as shown in FIGS. 6b and
6c, wherein the greater cross section thereof is at a position
closer to a cortical rim opposite to a pedicle of said vertebral
body and the smaller cross section thereof is at a position near to
the cortical rim close to the pedicle of said vertebral body.
Preferably, the long diameters of the elliptical cross sections of
the pasty medicine 30 are in the same direction of the vertebral
column indicated by a dot line 82 in FIG. 6c, thereby there may be
enough room in the vertical body 80 for implanting two pasty
medicines 30.
[0046] The pasty medicine 30 is a mixture of a liquid and one or
more kinds of vertebral body drugs in the form of powder, granule,
or colloid. The pasty medicine 30 is capable of solidification.
[0047] Upon completion of the solidification of the pasty medicine
30 in the vertebral body 80, the filling member 60 must be
extracted from the hole 81 of the vertebral body 80, so as to leave
only the medicine 30 in the vertebral body 80 to prevent the
rejection of the filling member 60 by the human body. The
extraction of the filling member 60 from the hole 81 of the
vertebral body 80 involves a first step in which the second end 512
of the second thread 51 is pulled upward as indicated by an arrow
in FIG. 4a. 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. 4b. The opening 65 is thus unfastened
completely.
[0048] After the opening 65 being unfastened, the rolled-up
double-layer end is retreated from the solidified medicine 30 by
pulling a free end of the outer layer 611 of the double-layer wall
61, while one end of the inner layer 612 is connected to the guide
tube 40 as an injection port of said holding portion of the said
filling member 60, whereby said solidified medicine 30 is released
from said filling member 60 and is disposed in the vertebral body
80, as shown in FIGS. 7a and 7b. The filling member and the guide
up 40 are pulled from the hole 81 of the vertebral body 80, so as
to leave only said solidified medicine 30 in the vertebral body
80.
[0049] As shown in FIGS. 8a and 8b, the flexible wall 91 of the
filling member 90 of the extractable filler 10 of the present
invention may have a curved profile. Accordingly, the pasty
medicine injected into the filling member 90 in the vertebral body
will also has a curved profile.
[0050] The embodiments of the present invention described above are
to be regarded in all respects as being illustrative and
nonrestrictive. Accordingly, the present invention may be embodied
in other specific forms without deviating from the spirit thereof.
The present invention is therefore to be limited only the scopes of
the following claims.
* * * * *