# Patent

## Title
Method for inserting medicine into animal tissue

## Abstract

An extractable device is used to insert a medicinal filling into an animal tissue. The device comprises a filling member and a pasty medicine. The filling member is made of a flexible and hermetic 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 animal tissue. 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 animal tissue so as to leave only the medicine in the animal tissue.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation of U.S. patent application Ser. No. 10/652,470, entitled “Extractable Filler for Inserting Medicine into Animal Tissue,” filed Sep. 2, 2003, now U.S. Pat. No. 7,175,628, which claims priority to Taiwanese patent application No. 92113771, filed May, 21, 2003, the disclosure of each of which is hereby incorporated by reference in its entirety.


FIELD OF THE INVENTION
The present invention relates generally to an instrument which is used in the restorative operation of animal tissue disorder. More specifically this surgical instrument can be used to insert a medical material into an animal tissue such that the instrument can be separated from the medical material and drawn out of the animal tissue so as to avert the possibility of tissue rejection.
BACKGROUND OF THE INVENTION
The surgical treatment of animal tissue 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.
In order to prevent the drawbacks of the balloon method described above, the filler-insertion method is used to implant the medicine in animal tissue in such a way that the medicine is contained in the filler, and that both the medicine and the filler are implanted in the animal tissue. This filler-insertion method is often carried out in danger of the tissue rejection of the filler.
SUMMARY OF THE INVENTION
The present invention provides an extractable device for inserting a medicinal filling into an animal tissue, said device comprising:
a filling member comprising a flexible and hermetic 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, each having one end for fastening releasably said opening of said holding portion in such a manner that said opening is leakproof; and
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 animal tissue whereby said pasty medicine solidifies in said holding portion of said filling member;
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 animal tissue so as to leave only said medicine in the animal tissue.
Preferably, said holding portion of said filling member is integrally formed by said flexible and hermetic wall into a body in the form of sac, bag, or ball.
Preferably, said pasty medicine is a mixture of a liquid and a medicinal powdered substance or medicinal granular substance.
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.
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.
Preferably, said flexible and hermetic wall is a double-layer tubular wall having one end of an inner layer thereof being provided with said injection port of said holding portion, and having another end thereof being a folded double-layer end with said opening of said holding portion, 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.
Preferably, said one or more thread is between said inner layer and said outer layer of said double-layer tubular wall.
The present invention also discloses a method for implanting a solidified medicine into an animal tissue comprising:
inserting a filling member in a hole of an animal tissue, said filling member comprising a flexible and hermetic 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;
injecting a pasty medicine into said holding portion via said injection port of said filling member, whereby said pasty 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 animal tissue so as to leave only said solidified medicine in the animal tissue.
Preferably, the method further comprising 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.
The flexible wall of the filling member of the present invention is hermetic and made of a biocompatible or biosynthetic material, such as rubber, elastic plastic, titanium, goat intestine, and the like. 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.
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.
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
FIG. 1 shows a sectional schematic view of the present invention.
FIGS. 2a-2c are schematic views illustrating the lashing of the opening of the holding portion of the filling member of the present invention.
FIGS. 3a and 3b are sectional schematic view of the present invention at work.
FIGS. 4a-4c 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.
FIG. 5a shows a schematic view of the connection tube of the implantation-injection apparatus of the present invention.
FIGS. 5b and 5c are sectional schematic views illustrating the process in which the filling member of the present invention is extracted from the animal tissue.
FIGS. 6a and 6b are schematic views illustrating that the opening of the holding portion of the filling member of the present invention is releasably lashed by a thread.
FIGS. 7a-7d are schematic views illustrating a process in which the opening of the holding portion of the filling member of the present invention is releasably lashed by two threads in conjunction with sewing.
FIG. 8a is a schematic view illustrating a process in which a double-layer wall of the holding portion of the filling member of the present invention is formed.
FIG. 8b illustrating a process in which the double-layer wall of the holding portion of the filling member of the present invention is retreated from the solidified medicine.



DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
As shown in FIG. 1, an extractable filler 10 embodied in the present invention comprises a filling member 20, a pasty medicine 30, a connection 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 pasty medicine 30 is injected into the holding portion 22 via the connection 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.
As shown in FIG. 2a, the holding portion 22 of the filling member 20 is integrally formed of the hermetic flexible wall 21, and is provided with an opening 24 opposite to the injection port 23 of the filling member 20. The filling member 20, for example, is an inflatable rubber balloon with an additional opening like the opening 24. 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.
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, as indicated by a dotted line 4-4 in FIG. 2b. 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. 2c. As a result, the opening 24 of the filling member 20 is leakproof.
As shown in FIGS. 3a and 3b, the filling member 20 is first inserted into a blind hole 71 of an animal tissue 70. The pasty medicine 30 is then injected into the holding portion 22 of the filling member 20 by a syringe 60 in conjunction with the connection tube 40. The filling member 20 is thus inflated by the medicine 30, as shown in FIG. 3b. The connection tube 40 has one end 41 which is connected with the filling member 20, and another end 42 which is connected to one end 611 of a barrel 61 of the syringe 60. A plunger 62 is slidably inserted into another end 612 of the barrel 61 in which the pasty medicine 30 is contained.
The pasty medicine 30 is a mixture of a liquid and one or more kinds of animal tissue drugs in the form of powder, granule, or colloid. The pasty medicine 30 is capable of solidification.
Upon completion of the solidification of the pasty medicine 30 in the blind hole 71 of the animal tissue 70, the filling member 20 must be extracted from the blind hole 71 of the animal tissue 70, so as to leave only the medicine 30 in the blind hole 71 of the animal tissue 70 to prevent the rejection of the filling member 20 by the animal tissue 70. The extraction of the filling member 20 from the blind hole 71 of the animal tissue 70 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, as shown in FIG. 4b. 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. 4c. The opening 24 is thus unfastened completely.
As shown in FIG. 5a, the connection tube 40 is provided in one end 41 with a pointed projection 411 inside the tube. As the connection tube 40 is slightly twisted, the solidified medicine 30 is severed by the pointed projection 411 of the connection tube 40. The filling member 20 can be drawn out of the blind hole 71 of the animal tissue 70 by the connection tube 40, as illustrated in FIG. 5b and FIG. 5c. As a result, only the medicine 30 is left in the blind hole 71 of the animal tissue.
The opening 24 of the filling member 20 may be fastened by only one thread 50, as illustrated in FIGS. 6a and 6b. The thread 50 has a first end 501 and a second end 502. With the thread 50, a knot is formed to lash the opening 24 of the filling member 20 in such a manner that the flexible wall 21 of the opening 24 is surrounded by a loop as indicated by a line 5-5 in FIG. 6a. With the second end 502 of the thread 50 remaining in the stationary state, the first end 501 is pulled to fasten the opening 24. The opening 24 is unfastened by pulling the second end 502 of the thread 20, thereby resulting in separation of the filling member 20 from the thread 50.
The thread 50 can be also used to form a different knot, as shown in FIG. 6b. The flexible wall 21 of the opening 24 of the filling member 20 is surrounded by a loop as indicated by a line 6-6 in FIG. 6b. As the first end 501 of the thread 50 is pulled in a direction away from the filling member 20, the opening 24 of the filling member 20 is lashed to become leakproof. The opening 24 of the filling member 20 is unlashed to enable the filling member 20 to separate from the thread 50 by pulling the second end 502 of the thread 50.
The opening 24 of the filling member 20 can be releasably fastened by sewing in conjunction with two threads 50 and 51, as illustrated in FIGS. 7a-7d. With the first thread 50, a plurality of loops are formed. These loops are joined with the flexible wall 21 of the opening 24 by sewing. The second thread 51 is put through the loops of the first thread 50. As the second thread 51 is pulled out of the loops of the first thread 50, the first thread 50 becomes separated from the flexible wall 21 of the opening 24 of the filling member 20, as illustrated in FIGS. 7b-7d. As a result, the opening 24 is unfastened. Such a fastening as described above is similar to that which is commonly used to fasten the opening of a cement or flour bag.
A further embodiment of the present invention is shown in FIG. 8a, and FIG. 8b, which is similar to the embodiment shown in FIGS. 1 to 2c, except that a filling member 80 is formed of a double-layer wall 81 and the first thread 51 and second thread 52 are located between an inner layer 812 and an outer layer 811 of the double-layer wall 81. As shown in FIG. 8a, a flexible and hermetic tubular wall is tied at an intermediate point thereof by the threads 50 and 51 at the beginning. The lower portion 811 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 812 of the tubular wall (will become an inner layer). The rolled-up end of said double-layer wall 81 is provided with an opening 82 of the holding portion 22, which is lashed by the two threads 50 and 51. The opening 82 is unfastened by pulling the threads 50 and 51 the same way as shown in FIGS. 4a to 4c. As shown in FIG. 8b, the rolled-up double-layer end is retreated from the solidified medicine 30 by pulling a free end of the outer layer 811 of the double-layer wall 81, while one end of the inner layer 812 is connected to the connection tube 40 as an injection port of said holding portion 22 of the said filling member 80, whereby said solidified medicine 30 is released from said filling member 80. A working tube 43 is used to accommodate the connection tube 40, the threads 50 and 51 and the free end of the outer layer 811 of the double-layer wall 81 of the filling member 80.
The embodiments of the present invention described above are to be regarded in all respects as belong 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.

## Claims

1. A method for implanting a solidified medicine into an animal tissue, comprising:
inserting into the animal tissue a flexible container defining a proximal injection port and a releasably closable distal opening, the proximal injection port and the releasably closable distal opening each being defined by the flexible container prior to the inserting, the releasably closable distal opening being closed during the inserting;
after the inserting, at least partially filling the container with a solidifiable medicinal filling;
allowing the medicinal filling to at least partially solidify within the container; and
extracting the container form the animal tissue when the distal opening of the container is open such that the medicinal filling is removed from the container through the distal opening, the medicinal filling remaining within the animal tissue after the container is extracted.

2. The method of claim 1, further comprising injecting the filling into the container through the proximal injection port.

3. The method of claim 1, further including allowing the medicinal filling to completely solidify after extracting the container.

4. The method of claim 1, wherein the container includes an inner layer and an outer layer.

5. The method of claim 1, wherein at least partially filling the container includes injecting the solidifiable medicinal filling from an injection tool through the proximal injection port of the container.

6. The method of claim 5, further comprising:
opening the distal opening of the container; and
injecting an additional amount of the solidifiable medicinal filling into the container after the opening the distal opening of the container.

7. The method of claim 5, further comprising:
opening the distal opening of the container; and
injecting an additional amount of the solidifiable medicinal filling into the container after the opening the distal opening of the container and after at least partially extracting the container such that the solidifiable medicinal filling exits the distal opening of the container.

8. The method of claim 1, wherein the extracting includes severing the solidifiable medicinal filling from an injection tool.

9. The method of claim 1, wherein the container is shaped like one of a ball or a bag.

10. The method of claim 1, wherein the flexible container is hermetic.

11. 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 outlet, the proximal inlet and the distal outlet each being defined by the flexible container prior to the inserting, the distal outlet being closed during the inserting;
after the inserting, inserting a solidifiable medicinal filling through the proximal inlet of the container;
allowing the medicinal filling to at least partially solidify within the container;
opening the distal outlet of the container;
disposing the medicinal filling in the animal tissue through the distal outlet; and
removing the container from the animal tissue.

12. The method of claim 11, further including allowing the solidifiable medicinal filling to further solidify after removing the container from the animal tissue.

13. The method of claim 11, wherein the medicinal filling completely solidifies before disposing the medicinal filling in the animal tissue.

14. The method of claim 11, wherein the distal outlet includes at least one releasable thread configured to releasably seal the distal outlet.

15. The method of claim 14, wherein opening the distal outlet of the container includes applying a pulling force to a first end of the thread.

16. The method of claim 14, wherein the at least one releasable thread includes two releasable threads, and wherein opening the distal outlet of the container includes applying a pulling force to a first end of the first thread and then applying a pulling force to a first end of the second thread.

17. The method of claim 11, wherein the flexible container is hermetic.

18. A method for placing a solidifiable medicine into an animal tissue, comprising:
inserting into the animal tissue a flexible container having a proximal inlet, a distal outlet, and a holding portion, the proximal inlet and the distal outlet each being defined by the flexible container prior to the inserting;
after the inserting, injecting a solidifiable medicinal filling into the holding portion of the container through the proximal inlet;
allowing the medicinal filling to at least partially solidify within the container;
disposing the filling in the animal tissue through the distal opening by at least partially removing the container from the animal tissue.

19. The method of claim 18, wherein the distal outlet of the container is releasably sealed by at least one thread prior to the inserting.

20. The method of claim 18, further including opening the distal outlet prior to removing the container.

21. The method of claim 18, further including allowing the solidifiable medicinal filling to further solidify after removing the container from the animal tissue.

22. The method of claim 18, wherein the flexible container is hermetic.