Paste-like bone cement
A paste contains at least one monomer for radical polymerization, at least one polymer that is soluble in said at least one monomer for radical polymerization, and at least one filling agent that is poorly soluble or insoluble in said at least one monomer for radical polymerization. The filling agent is a particulate inorganic calcium salt comprising the following properties: at least 90% by weight of the particulate inorganic calcium salt have a particle size of less than 63 μm, as determined by means of sieve analysis; and the solubility in water of the particulate inorganic calcium salt at 20° C. is less than 8.5 g per liter. A kit and the paste is usable for mechanical fixation of articular endoprostheses, for covering skull defects, for filling bone cavities, for femuroplasty, for vertebroplasty, for kyphoplasty, for the manufacture of spacers or for the production of carrier materials for local antibiotics therapy, as well as a form body.
1. A paste containing at least one monomer for radical polymerisation, at least one soluble polymer that is soluble in said at least one monomer for radical polymerisation, at least one filling agent that is poorly soluble or insoluble in said at least one monomer for radical polymerisation and at least one polymerisation initiator selected from the group of substances consisting of cumene-hydroperoxide, 1,1,3,3-tetramethylbutyl-hydroperoxide, t-butyl-hydroperoxide, t-amyl-hydroperoxide, di-isopropylbenzen-mono-hydroperoxide, and a mixture of at least two of these substances thereof,
wherein the at least one filling agent comprises a particulate inorganic calcium salt having the following properties i) and ii):
i) at least 90% by weight of the particulate inorganic calcium salt have a particle size of less than 63 μm, as determined by means of sieve analysis; and
ii) the solubility in water of the particulate inorganic calcium salt at 20° C. is less than 8.5 g per liter,
wherein the particulate inorganic calcium salt is calcium carbonate present in an amount of 5 to 15% by weight to the total weight of the paste and the amount of particulate inorganic calcium salt is at least 50% by weight relative to the total amount of the at least one filling agent, and
further wherein the at least one soluble polymer is selected from the group of soluble polymers consisting of poly(methacrylic acid methylester), poly(methacrylic acid ethylester), poly(methylmethacrylic acid propylester), poly(methacrylic acid isopropylester), poly(methyl-methacrylate-co-methylacrylate), poly(styrene-co-methylmethacrylate), and a mixture of at least two of said soluble polymers.
2. The paste according to claim 1 , wherein the filling agent comprises the properties i) and ii):
i) at least 90% by weight of the particulate inorganic calcium salt have a particle size of less than 20 μm, as determined by means of sieve analysis; and
ii) the solubility in water of the particulate inorganic calcium salt at 20° C. is less than 5 g per liter.
3. The paste according to claim 1 , wherein the paste contains, in addition, at least one polymerisation accelerator, and, if applicable, at least one polymerisation co-accelerator.
4. The paste according to claim 1 , wherein the paste is tack-free in accordance with ISO 5833 no later than 15 minutes after being produced.
5. A paste containing at least one monomer for radical polymerisation, at least one soluble polymer that is soluble in said at least one monomer for radical polymerisation, at least one filling agent that is poorly soluble or insoluble in said at least one monomer for radical polymerisation and at least one polymerisation initiator selected from the group of substances consisting of cumene-hydroperoxide, 1,1,3,3-tetramethylbutyl-hydroperoxide, t-butyl-hydroperoxide, t-amyl-hydroperoxide, di-isopropylbenzen-mono-hydroperoxide, and a mixture of at least two of these substances thereof, wherein the at least one filling agent comprises a particulate inorganic calcium salt having the following properties i) and ii):
i) at least 90% by weight of the particulate inorganic calcium salt have a particle size of less than 63 μm, as determined by means of sieve analysis; and
ii) the solubility in water of the particulate inorganic calcium salt at 20° C. is less than 8.5 g per liter, and
wherein the particulate inorganic calcium salt is calcium carbonate or a mixture of calcium carbonate and at least one additional substance and is present in an amount of 5 to 15% by weight to the total weight of the paste and the amount of particulate inorganic calcium salt is at least 50% by weight relative to the total amount of the at least one filling agent, and
wherein the at least one additional substance is selected from the group of substances consisting of dolomite, calcium sulfate dihydrate, α-tricalcium phosphate, β-tricalcium phosphate, hydroxyapatite, octacalcium phosphate, amorphous calcium phosphate, fluoroapatite, chloroapatite, carbonate apatite, and a mixture of at least two of these substances thereof.
6. The paste according to claim 5 , wherein the at least one additional substance is selected from the group of substances consisting of dolomite, calcium sulfate dihydrate, β-tricalcium phosphate, hydroxyapatite, and a mixture of at least two of these substances thereof.
7. A paste containing at least one monomer for radical polymerisation, at least one soluble polymer that is soluble in said at least one monomer for radical polymerisation, at least one filling agent that is poorly soluble or insoluble in said at least one monomer for radical polymerisation and at least one polymerisation initiator selected from the group of substances consisting of cumene-hydroperoxide, 1,1,3,3-tetramethylbutyl-hydroperoxide, t-butyl-hydroperoxide, t-amyl-hydroperoxide, di-isopropylbenzen-mono-hydroperoxide, and a mixture of at least two of these substances thereof,
wherein the at least one filling agent comprises a particulate inorganic calcium salt having the following properties i) and ii):
i) at least 90% by weight of the particulate inorganic calcium salt have a particle size of less than 63 μm, as determined by means of sieve analysis; and
ii) the solubility in water of the particulate inorganic calcium salt at 20° C. is less than 8.5 g per liter,
wherein the particulate inorganic calcium salt is calcium carbonate present in an amount of 5 to 15% by weight to the total weight of the paste and the amount of particulate inorganic calcium salt is at least 50% by weight relative to the total amount of the at least one filling agent, and
further wherein the monomer for radical polymerisation is a methacrylic acid ester.