Patent Application
20110288530
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.
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.
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.
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, each having one end for 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 whereby said flowable 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 spinal disc so as to leave only said flowable material in the spinal disc;
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.
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, 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.
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.
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.
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.
Preferably, said tubular wall is provided with a plurality of through holes and is permeable.
The present invention also discloses 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 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;
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.
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.
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.
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.
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.
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.
a shows a longitudinal sectional view of a one-layered wall of the filling member of the present invention.
b shows a longitudinal sectional view of a multi-layered wall of the filling member of the present invention.
a shows a sectional view of the filling member placed within the spinal disc.
b shows a sectional view of the filling member placed within the spinal disc containing a full volume of flowable material.
a shows a sectional view of the filling member with the said opening in the open condition.
b is a sectional view showing the removal of the filling member from the spinal disc.
a is a sectional view showing the flowable material within the spinal disc.
b is a sectional view showing the flowable material at more than one location within the spinal disc.
As shown in
As shown in
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
The flexible wall 21 of the filling member 20 is of a one-layered construction, as shown in
As shown in
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.
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
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
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
As shown in
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.
| Number | Date | Country | Kind |
|---|---|---|---|
| PCT/US2005/031356 | Sep 2005 | US | national |
| Number | Date | Country | |
|---|---|---|---|
| 60606611 | Sep 2004 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 12829500 | Jul 2010 | US |
| Child | 13195483 | US | |
| Parent | 11574562 | Mar 2007 | US |
| Child | 12829500 | US |
