AU5197701A

AU5197701A - Orthopedic filling material and method of use thereof

Info

Publication number: AU5197701A
Application number: AU51977/01A
Authority: AU
Inventors: Chih-I Lin; Shengfu Lin
Original assignee: Individual
Current assignee: Individual
Priority date: 2001-06-18
Filing date: 2001-06-18
Publication date: 2002-12-19

Description

AUSTRALIA

Patents Act 1990 COMPLETE SPECIFICATION STANDARD PATENT Applicant(s): Chih-I LIN Shengfu LIN 0 *o S* 0 Invention Title: ORTHOPEDIC FILLING MATERIAL AND METHOD OF USE THEREOF The following statement is a full description of this invention, including the best method of performing it known to me/us: ORTHOPEDIC FILLING MATERIAL AND METHOD OF USE THEREOF FIELD OF THE INVENTION The present invention relates generally to an orthopedic filling material, and more particularly to an orthopedic filling material prepared from plaster of Paris having a specific viscosity, and the method of use of the orthopedic filling material.

BACKGROUND OF THE INVENTION The bone cement is one of the important orthopedic filling materials and is used for filling the bone marrow gap in the orthopedic surgery, and the gap between the bone and the implant, thereby enabling the bone to have an appropriate strength after the surgery, or enabling the implant to be joined intimately with the bone. However, the bone cement is incapable of being absorbed by a human body and is apt to affect the blood-making function of the marrow.

•ooo• **The bone graft is another one of the important orthopedic filling materials. The advantage of the bone graft is that it is capable of promoting the bone ingrowth. However, the bone graft must be accompanied with an implant in view of the fact that the bone graft is incapable of bearing the burden of the pressure of the body weight of a ooooo patient prior to its fusion with the bone.

The synthetic orthopedic granule is also one of the important orthopedic filling materials; nevertheless, it shares with the bone graft the same drawback described above.

-2- SUMMARY OF THE INVENTION An objective of the present invention is to provide a calcium sulfate-containing orthopedic filling material having a specific viscosity.

Another objective of the present invention is to provide a method of using a plaster of Paris as an orthopedic filling material for the treatment of a deformed bone in a patient, wherein said plaster of Paris is a paste having a viscosity ranging from 20 to 75 poises, and preferably, ranging from 30 to 60 poises.

DETAILED DESCRIPTION OF THE INVENTION An orthopedic filling material made of plaster of Paris is disclosed in the present invention, which is a paste having a viscosity ranging from to 75 poises, and preferably, ranging from 30 to 60 poises.

A suitable process for preparing the paste of the present invention 555..i 15 comprises mixing 15-80%, preferably 20-75%, and more preferably 30-60%, by weight of calcium sulfate half-hydrate (CaSO 4 .0.5H 2 0) and 85-20% by ooooi weight of water, an aqueous solution, an aqueous dispersion, or an aqueous suspension; stirring the resulting mixture into a paste. The resulting paste is rested for a period of time to have a desired viscosity.

A treatment of a deformed bone according to the present invention comprises injecting said paste into a cavity of a bone or a ooooo vertebra, which requires treatment, as an orthopedic filling material, so that the injected paste will become hard in said cavity, and eventually will be absorbed by the patient.

Preferably, said paste of the present invention comprises 15-80%, more preferably 20-75%, and most preferably 30-60% by weight of calcium -3sulfate; and water, an aqueous solution, an aqueous dispersion, or an aqueous suspension as the balance.

The water used in the present invention can be distilled water, reverse-osmosis water, or pure water produced by other means.

The aqueous solution used in the present invention may contain certain remedial drugs (such as antibiotics, and bone ingrowth drugs), nutrients, or other additives.

The aqueous dispersion used in the present invention may contain remedial drugs (such as antibiotics, and bone ingrowth drugs), nutrients, or other additives, which are dispersed in water with a dispersing agent.

The aqueous suspension used in the present invention may contain remedial drugs (such as antibiotics, and bone ingrowth drugs), S•nutrients, or other additives.

15 In the process for preparing the paste of the present invention, drugs or nutrients may be added before the mixing or in the midst of the °oeeo mixing such that they are mixed with the calcium sulfate half-hydrate and water, the aqueous solution, the aqueous dispersion or the aqueous suspension.

The drugs, nutrients, and additives may be in the form of solid, S* liquid, or gas. The drugs and nutrients added should not have adverse •effect on the hardening of the paste. The additives can have a direct effect or an indirect effect on the paste, such as hardening promoters, hardening delaying agents, and the like.

The paste of the present invention has a viscosity ranging between 20 and 75 poises, preferably between 30 and 60 poises. If the -4viscosity of the paste is too low, the paste is apt to disperse quickly into the body fluid before the paste solidifies in the cavity of the bone or vertebra.

If the viscosity of the paste is excessively high, the paste can not be easily injected into the cavity of the bone or vertebra.

The chemical formula of the calcium sulfate half-hydrate used in preparing the paste of the present invention consists essentially of CaSO 4 O0.5H 2 0. The chemical formula of the calcium sulfate of the paste of the present invention is a mixture of CaSO 4 -nH20O, in which n has a value of 0, 0.5, 2, or others.

The viscosity of the paste of the present invention is measured by a RVS-1 Rotary viscometer available from Fargo Company, Taipei, Taiwan.

Examples 1-12 A paste was formed by mixing at 30rpm for one minute at 27 0 C 15 grams of the half-water calcium sulfate and 3.6 ml of pure water. The paste was rested without disturbance. 5 ml of paste was then taken out with an injector having an injection outlet inner diameter of 0.8 mm at different take-out time, and immediately injected on a bottom of a beaker containing 100 ml saline water. Thereafter, the hardening of the injected paste in the saline water was observed 20 minutes after injection. The results are shown in Table 1.

Table 1 Example Take-out time Viscosity Hardening Take-out/Injection (min) (poise) Statea) Condition b) 1 2 14 X 2 3 20 A 3 4 28 AA 4 5 30 0 8 31 O 6 10 32 O 7 11 48 O 8 12 55 O 9 13 58 O 14 67 O 11 15 70 O_ 12 16 80 O a X: no hardening, the injected paste disperses A: the injected paste becomes flat and hard AA: the bottom of the injected paste becomes bigger and hard 0: the injected paste become hard with substantially no change in

S.

S

shape b) take-out and injection without problem injection being slightly difficult injection being extremely difficult Examples 13-20: These examples were similar to Examples 1-12, except that the agitation time was changed to 30 seconds, and that the temperature was changed to 30 0 C. The results are shown in Table 2.

-6- Table 2 Example Take-out Time Viscosity Hardening Take-outllnjection (min) (poise) State') I Condition') 13 4 27 AA+ 14 5 30 0 6 31 0 16 7 42 0 17 8 56 0 18 9 72 19 10 80 0 .11 1 82 0 a) )defined as in Table 1 Examples 2 1-27: These examples were similar to Examples 1-12, except that the agitation time was 10 seconds, and that the temperature was 30'C, and furthat that 0.9wt% of sodium chloride solution was used in place of pure water. The results are shown in Table 3.

-7- Table 3 Example Take-out Time Viscosity Hardening Take-out/Injection (min) (poise) State a Conditionb) 21 10 20 A 22 20 30 O 23 50 52 O 24 80 44 O 100 56 0 26 120 78 0 27 140 180 Could not be taken out

C.

.C

C

b defined as in Table 1 Examples 28-32: 5 9.5 grams of calcium sulfate half-hydrate and 0.5 gram of hydroxyapatite (HA) were mixed with 3.6 ml of pure water at 29 0 C and were agitated for 20 seconds. The paste was rested without disturbance. ml of paste was then taken out with an injector having an injection outlet inner diameter of 0.8 mm at different take-out time, and immediately injected on a bottom of a beaker containing 100 ml saline water.

Thereafter, the hardening of the injected paste in the saline water was observed. The results are shown in Table 4.

-8- S~~~~Table 4 Example Take-out Time Viscosity Hardening Take-out'lnjection min) (poise) State') Condition b) 28 30 40 0 2=9 50 52 0 100 60 0 31 120 75 32 150 90' 0b) defined as in Table 1 *0.e Examples 33-40: These examples were similar to Examples 28-32, except that the amount of pure water was increased to 4.8 ml. The results are shown in Table 0 -9- ____Table_5 Example Take-out Time Viscosity Hardening Take-out/Injection (sec) (poise) State') Condition') 33 200 17 X 34 210 19 A 220 25 AIL 36 230 28 AIL 37 240 33 0 38 300 42 0 39 330 58 0 340 77 1 0 b) defined as in Table 1 Examples 41-18: These examples were similar to Examples 28-32, except that the amount of pure water was increased to 6 ml. The results are shown in Table 6.

Table 6 Example Take-out Time Viscosity Hardening Take-out/Injection (sec) (poise) Statea) Conditionb) 41 300 20 X 42 320 21 A 43 350 28 AA 44 400 29 AA 420 32 0 46 450 53 0 47 480 64 O 48 550 85 0 b) defined as in Table 1 Examples 49-50: These examples were similar to Examples 1-12, except that an aqueous suspension containing 0.5% by weight of calcium sulfate dihydrate was used in place of the pure water. The results are shown in Table 7.

Table 7 Example Take-out Time Viscosity Hardening Take-out/Injection (sec) (poise) Statea) Conditionb) 49 30 35 O 60 48 O a) b) defined as in Table 1 i0 For the purposes of this specification it will be clearly understood that the word "comprising" means "including but not limited to", and that the word "comprises" has a corresponding meaning.

It is to be understood that, if any prior art publication is referred to herein, such reference does not constitute an admission that the publication forms a part of the common general knowledge in the art, in Australia or any other country.

I S

S

See

Claims

3. The use as defined in claim 1, wherein the treatment of a 11 deformed bone comprising injecting said paste into a cavity of a bone or a vertebra, which require treatment, as an orthopedic filling material, so that 13 the injected paste will become hard in said cavity, and eventually will be 14 absorbed by the patient. 16
4. The use as defined in claim 1, wherein said paste comprises
9.. 17 15-80% by weight of calcium sulfate; and water, an aqueous solution, an s18 aqueous dispersion, or an aqueous suspension as the balance. 19 S9 20 5. The use as defined in claim 4, wherein said paste contains 21 75% by weight of calcium sulfate. 22 23 6. The use as defined in claim 5, wherein said paste contains 24 60% by weight of calcium sulfate. I n
12- 1 7. The use as defined in claim 1, wherein said paste is prepared 2 by mixing 15-80% by weight of calcium sulfate half-hydrate (CaSO 4 .0.5H 2 0) 3 and 85-20% by weight of water, an aqueous solution, an aqueous 4 dispersion, or an aqueous suspension; and stirring the resulting mixture into a paste. 6 7 8. The use as defined in claim 7, wherein 20-75% by weight of 8 calcium sulfate half-hydrate is mixed. 9 9. The use as defined in claim 8, wherein 30-60% by weight of 11 calcium sulfate half-hydrate is mixed. 12 Dated this 18th day of June 2001 Chih-I LIN and Shengfu LIN By their Patent Attorneys GRIFFITH HACK Fellows Institute of Patent and Trade Mark Attorneys of Australia