Pmma based composition for use in discoplasty procedures
AssigneeInossia AB
InventorsKarin Cecilia Persson, Malin Katarina Nilsson
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Abstract
The present invention relates to a poly(methyl methacrylate) (PMMA) based bone cement composition comprising a softener and the use of said bone cement composition in discoplasty procedures. The use is characterized by injection of the composition into a disc, hence stabilizing the intravertebral disc, reducing lower back pain and increasing life quality in the affected subject.
Claims102
A PMMA-based bone cement composition comprising a bone cement component and a cement softener component, wherein the bone cement component comprises 43-50% (w/w) poly(methyl methacrylate), 18-23% (w/w) barium sulphate, 8-14% (w/w) benzoyl peroxide;
- and 28-34% (v/w) methyl methacrylate, 0.01-1% (v/w) N,N,-dimethyl-p-toluidine and 50-100 ppm hydroquinone.
The composition according to any one of the preceding claims, wherein the bone cement component comprises 46.8% (w/w) poly(methyl methacrylate), 20.5% (w/w) barium sulphate, 11% (w/w) benzoyl peroxide, 31.3% (v/w) methyl methacrylate, 0.3% (v/w) N,N,-dimethyl-p-toluidine and 75 ppm hydroquinone.
The composition according to any one of the preceding claims, wherein the cement softener component is added in an amount equivalent to 2-20% (v/w) of the bone cement component, such as 2-15% (v/w), such as 2-12% (v/w), such as 2-10% (v/w), such as 2-8% (v/w), such as 3-7% (v/w), such as 4-6% (v/w), such as 2-5% (v/w), such as 5% (v/w).
The composition according to any one of the preceding claims, wherein the bone cement component and the cement softener component are present in a ratio of 1:19;
- such as 1:18, such as 1:17;
- such as 1:16;
- such as 1:15;
- such as 1:14;
- such as 1:13.
The composition according to any one of the preceding claims, wherein the cement softener component and the bone cement component are present in a ratio between of 1:0.05;
- such as 1:0.06;
- such as 1:0.07;
- such as 1:0.08.
The composition according to any one of the preceding claims, wherein the cement softener component and the bone cement component are present in a ratio of 1:0.053.
The composition according to any one of the preceding claims, wherein the bone cement composition is obtained by mixing a powder cement component, a liquid cement component, and a liquid softener, prior to administration.
The composition according to any one of claims 8-13, wherein the liquid component comprises 84.8% methyl methacrylate, 0.8% N,N,-dimethyl-p-toluidine, 75 ppm hydroquinone, and 10-20%, for example 14.4% cement softener.
The composition according to any one of the preceding claims, wherein the cement softener is linoleic acid, ricinoleic acid, oleic acid, methyl linoleate, castor oil, linseed oil, or tung oil.
The composition according to any one of the preceding claims, wherein the cement softener is linoleic acid.
The composition according to any one of the preceding claims, wherein a fraction of the poly(methyl methacrylate), in the powder component is partially pre-polymerized.
The composition of any one of the preceding claims, wherein the composition is made from 18 gram of powder component consisting of 68.4% PMMA, 30% of barium sulphate, 1.6% of benzoyl peroxide, 8.3 mL of liquid component consisting of 99.1% methyl methacrylate, 0.9% N,N-dimethyl-p-tolouidine and 75 ppm hydroquinone, and 1.4 mL of linoleic acid.
The composition according to any one of the preceding claims, wherein the liquid cement component and the powder component of the PMMA based bone cement comprising a bone cement softener are present in a 1:2.3 ratio.
The composition according to any one of the preceding claims, wherein the composition has an ex vivo elastic modulus below 2000 MPa measured 24 h after mixing, such as below 1500 MPa, preferably below 1100 MPa, even more preferably below 1000 MPa, even more preferably below 800 MPa, preferably when tested according to ISO5833:
- 2002.
The composition according to any one of the preceding claims, wherein the elastic modulus of the composition is stable for at least one year.
The composition according to any one of the preceding claims, wherein the composition has a compressive strength below 50 Mpa, such as below 40 Mpa, such as below 30 Mpa, such as below 20 Mpa, measured 24 hours after mixing, preferably when tested according to ISO5833:
- 2002.
The composition according to any one of the preceding claims, wherein the compressive strength of the composition is stable for at least one year.
The composition according to any one of the preceding claims, wherein the composition can withstand 5 million compression-compression loading cycles, with a frequency of 5 Hz, at a stress level of 5 MPa.
The composition according to any one of the preceding claims, wherein the PMMA based bone cement composition has a peak polymerization temperature below 40° C., such as below 30° C., such as below 28° C.
The composition according to any one of the preceding claims, wherein the PMMA-based composition has a maximum setting time up to 15 minutes, such as up to 17 minutes, such as up to 18 minutes, such as up to 19 minutes, such as up to 20 minutes, such as up to 25 minutes, such as up to 50 minutes.
A poly(methyl methacrylate) (PMMA)-based bone cement composition comprising a softener for use in discoplasty procedures in subjects in need thereof.
A method of percutaneous cement discoplasty (PCD) comprising identifying a subject in need of PCD, preparing a PMMA bone cement mixture comprising 43-46 w % poly(methyl methacrylate), 19-20 w % barium sulphate, 0.9-1.1 w % benzoyl peroxide, 28-31 v % methyl methacrylate, 0.15-0.3 v % N,N,-dimethyl-p-toluidine, 10-100 ppm hydroquinone, and 4-8 v % linoleic acid and administering a therapeutically effective amount of said composition to said subject.
Dependencies are inferred from the claim text.