US20110288528A1 - Extractable filler for inserting medicine into vertebral body - Google Patents

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.

Description

FIELD OF THE INVENTION
• 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
• 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.
• 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.
• 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
• An extractable device for inserting a medicinal filling into a vertebral body, 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, 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 vertebral body 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 vertebral body so as to leave only said medicine in the vertebral body,
• 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.
• 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.
• Preferably, aid 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, 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.
• 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.
• 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.
• The present invention also discloses a method for implanting a solidified medicine into a vertebral body comprising:
• 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;
• 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
• 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,
• 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.
• 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.
• 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.
• 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.
• 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 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.
• 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 schematic view of an extractable filler of the present invention.
• FIGS. 2aand2bare schematic views illustrating the lashing of the opening of the holding portion of the filling member of the present invention.
• FIG. 3ashows a longitudinal sectional view of a one-layered wall of the filling member of the present invention.
• FIG. 3bshows a longitudinal sectional view of a multi-layered wall of the filling member of the present invention.
• FIGS. 4aand4bare 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.
• FIGS. 5aand5bare 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.
• FIG. 5cis a schematic view of the extractable filler shown inFIGS. 5aand5bafter the double-layer wall of the holding portion of the filling member is formed.
• FIGS. 6ato6care sectional schematic views of the present invention at work.
• FIGS. 7aand7bare sectional schematic views illustrating the process in which the filling member of the present invention is extracted from the vertebral body.
• FIGS. 8aand8bare 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
• As shown inFIG. 1, anextractable filler10 embodied in the present invention comprises a fillingmember20, apasty medicine30, aguide tube40, and twothreads50 and51. The fillingmember20 is formed of aflexible wall21 and is provided with aholding portion23 and aninjection port24. Theflexible wall21 may be made of rubber or a flexible plastic material with perforated holes. Thepasty medicine30 is injected into theholding portion23 via theguide tube40 and theinjection port24. The dotted line3-3 shows a direction in which a section of the fillingmember20 is taken. Theholding portion23 has a shape similar to a cone with alongitudinal axis201, wherein twocross sections202 and203 perpendicular to thelongitudinal axis201 are elliptical. Thecross section202 has ashort diameter211 and along diameter221, and thecross section203 has ashort diameter212 and along diameter222, wherein theshort diameter211 and thelong diameter221 are longer than theshort diameter212 and thelong diameter222, respectively. When the fillingmember20 is inserted in a collapsed vertical body, thecross section202 is at a position closer to a cortical rim opposite to a pedicle of said vertebral body and thecross section203 is at a position near to the cortical rim close to the pedicle of said vertebral body. Preferably, thelong diameters221 and222 are in the same direction of the vertebral column.
• As shown inFIGS. 2aand2b, the holdingportion23 of the fillingmember20 is provided with anopening25 opposite to theinjection port24 of the fillingmember20. Theopening25 is lashed by twothreads50 and51. Thefirst thread50 has afirst end501 and asecond end502, while thesecond thread51 has afirst end511 and asecond end512. The twothreads50 and51 are in fact fastened releasably to theflexible wall21 near theopening25. The way by which they are fastened together is not shown in the drawing.
• Theopening25 of the holding portion22 of the fillingmember20 is securely tied up to prevent themedicine30 from leaking out of the holding portion22 by means of the twothreads50 and51 which are releasably entangled in such a manner that thefirst end511 of thesecond thread51 is wound around thefirst thread50. Upon completion of the winding process, theflexible wall21 surrounding theopening25 is located in a position between the twothreads50 and51, as indicated by a dotted line4-4 inFIG. 2a. Thereafter, both ends501 and502 of thefirst thread50, and thefirst end511 of thesecond thread51 are respectively pulled rightward and leftwards at the same time, as illustrated inFIG. 2b. As a result, theopening25 of the fillingmember20 is leakproof.
• Theflexible wall21 of the fillingmember20 is of a one-layered construction, as shown inFIG. 3a, or of a multi-layered construction, as shown inFIG. 3b. Theflexible wall21 is provided with a plurality ofpores213 permeable to fluids. If theflexible wall21 is of a multi-layered construction, theflexible walls21 are laminated in such a way that thepores213 are not corresponding in location to slow down the passage of the fluids.
• Theopening25 of the fillingmember20 is untied when thesecond end512 of thesecond thread51 is pulled upward as indicated by an arrow inFIG. 4a. As a result, the twothreads50 and51 become loosened. Thereafter, thefirst end501 of thefirst thread50 and thesecond end512 of thesecond thread51 are respectively pulled in a direction away from theopening24 of the fillingmember20, as illustrated inFIG. 5b. Theopening25 is thus unfastened completely.
• A further embodiment of the present invention is shown inFIGS. 5a,5band5c, which is similar to the embodiment shown inFIGS. 1 to 4b, except that a fillingmember60 is formed of a double-layer wall61 and thefirst thread51 and second thread52 are located between aninner layer612 and anouter layer611 of the double-layer wail61. As shown inFIGS. 5aand5b, a flexible and permeable tubular wall having aninjection port64 at one end is tied at an intermediate point thereof by thethreads50 and51 at the beginning. Thelower portion611 of the tubular wall (will become an outer layer) is then rolled up, so that it is inside out and covering up thethreads50 and51 and theupper portion612 of the tubular wall (will become an inner layer). The rolled-up end of said double-layer wall61 is provided with an opening52 of the holdingportion63, which is lashed by the twothreads50 and51. The holdingportion63 as shown inFIG. 5chas a conic shape similar to the embodiment shown inFIG. 1. Theopening65 can be unfastened by pulling thethreads50 and51 the same way as shown inFIGS. 4aand4b.
• As shown inFIGS. 6ato6c, the fillingmember60 of theextractable filler10 is inserted into ahole81 formed on avertebral body80, wherein a workingtube43 is inserted into thehole81 in advance to accommodate theguide tube40, thethreads50 and51 and the free end of theouter layer611 of the double-layer wall61 of the fillingmember60. Thepasty medicine30 is then injected into the holdingportion63 of the fillingmember60 by asyringe70 in conjunction with theguide tube40. Theguide tube40 has oneend41 in the holdingportion63, and anotherend42 connected to oneend711 of abarrel71 of thesyringe70. Aplunger72 is slidably inserted into anotherend712 of thebarrel61 in which thepasty medicine30 is contained. The fillingmember60 is thus inflated by themedicine30, as shown inFIGS. 6band6c, 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 thepasty medicine30 are in the same direction of the vertebral column indicated by adot line82 inFIG. 6c, thereby there may be enough room in thevertical body80 for implanting twopasty medicines30.
• Thepasty medicine30 is a mixture of a liquid and one or more kinds of vertebral body drugs in the form of powder, granule, or colloid. Thepasty medicine30 is capable of solidification.
• Upon completion of the solidification of thepasty medicine30 in thevertebral body80, the fillingmember60 must be extracted from thehole81 of thevertebral body80, so as to leave only themedicine30 in thevertebral body80 to prevent the rejection of the fillingmember60 by the human body. The extraction of the fillingmember60 from thehole81 of thevertebral body80 involves a first step in which thesecond end512 of thesecond thread51 is pulled upward as indicated by an arrow inFIG. 4a. As a result, the twothreads50 and51 become loosened. Thereafter, thefirst end501 of thefirst thread50 and thesecond end512 of thesecond thread51 are respectively pulled in a direction away from theopening24 of the fillingmember20, as illustrated inFIG. 4b. Theopening65 is thus unfastened completely.
• After theopening65 being unfastened, the rolled-up double-layer end is retreated from the solidifiedmedicine30 by pulling a free end of theouter layer611 of the double-layer wall61, while one end of theinner layer612 is connected to theguide tube40 as an injection port of said holding portion of the said fillingmember60, whereby said solidifiedmedicine30 is released from said fillingmember60 and is disposed in thevertebral body80, as shown inFIGS. 7aand7b. The filling member and the guide up40 are pulled from thehole81 of thevertebral body80, so as to leave only said solidifiedmedicine30 in thevertebral body80.
• As shown inFIGS. 8aand8b, theflexible wall91 of the fillingmember90 of theextractable filler10 of the present invention may have a curved profile. Accordingly, the pasty medicine injected into the fillingmember90 in the vertebral body will also has a curved profile.
• 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.

Claims (20)

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 ofclaim 1, in which the flexible container is permeable.

3. The device ofclaim 1, in which the flexible container is hermetic.

4. The device ofclaim 1, in which the thread is releasable upon application of an external pulling force.

5. The device ofclaim 1, in which the thread is releasable upon application of an external pushing force.

6. The device ofclaim 1, in which the container comprises a single-layered wall.

7. The device ofclaim 1, in which the container comprises a multi-layered wall.

8. The device ofclaim 1, in which the container comprises inner and outer layers.

9. The device ofclaim 1, further comprising means for injecting the solidifiable medicinal filling into the device through the injection port.

10. The device ofclaim 1, in which the permeable container is formed of a plurality of threads.

11. The device ofclaim 1, in which the permeable container is formed of a plurality of threads by weaving.

12. In combination, the device ofclaim 1 and an injection tool for injecting the solidifiable medicinal filling into the device through the injection port.

13. The combination ofclaim 12, in which the injection tool comprises a guide tube connected to the injection port.

14. The device ofclaim 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 ofclaim 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 ofclaim 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 ofclaim 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.

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