Absorbable putty-like implants and methods for their use for mechanical hemostasis of bone and for the treatment of osseous defects
View Patent ↗Disclosed are body-implantable, appropriately absorbable, biocompatible, putty-like compositions useful as mechanical hemostatic tamponades for the control of osseous hemorrhage arising from surgical intervention or trauma and for providing an osteoinductive matrix to foster improved bone healing.
1. A body-absorbable, mechanically hemostatic putty composition having no added water and consisting essentially of an intimate admixture of the following Components 1 and 2 and none, or any one or more, of the following Optional Components:
(1) an absorbable, finely powdered, carboxylic acid salt having a carboxylate anion, and a metallic cation, in intimate admixture with,
(2) an absorbable composition that is liquid at room temperature comprising a first member that consists of a liquid at room temperature selected from the group consisting of tocopherol, a C 2 -C 10 aliphatic monocarboxylic acid ester of tocopherol, a polycarboxylic acid ester of tocopherol, and mixtures thereof, and a second member that is consists of a block copolymer of ethylene oxide and propylene oxide wherein the block copolymer is liquid at room temperature,
(3) an optional absorbable anti-infective agent, and
(4) an optional absorbable colorant,
wherein the amounts of Components 1 and 2 and any Optional Components that may be present are sufficient to form a putty-like consistency at ambient temperature, and wherein Component 2 makes up 10-70% of the composition by weight and the first member makes up 4-5% of the composition by weight.
2. The composition of claim 1 wherein said composition is sterile.
3. The composition of claim 1 wherein the first member of Component 2 consists of a member selected from the group consisting of tocopherol, the acetate, butyrate, caproate, caprylate, caprate and intervening homolog esters thereof, and the citrate or malate esters thereof.
4. The composition of claim 3 wherein the first member of Component 2 consists of tocopherol or tocopheryl acetate.
5. The composition of claim 4 wherein the first member of Component 2 consists of tocopheryl acetate.
6. The composition of claim 1 wherein the carboxylate anion of Component 1 is selected from saturated or unsaturated carboxylic acids containing about 6 to 22 carbon atoms.
7. The composition of claim 6 wherein the carboxylate salt cation of Component 1 is calcium, magnesium, zinc, aluminum, lithium, or barium or mixtures thereof.
8. The composition of claim 7 wherein the carboxylate anion of Component 1 is an aliphatic acid selected from caprylic acid, capric acid, lauric acid, myristic acid, palmitic acid, stearic acid, arachidic acid, and intervening homologs thereof.
9. The composition of claim 8 wherein the carboxylate anion of Component 1 is stearic acid.
10. The composition of claim 8 wherein the carboxylate anion of Component 1 is palmitic acid.
11. The composition of claim 9 wherein the carboxylate salt cation of Component 1 is calcium.
12. The composition of claim 10 wherein the carboxylate salt cation of Component 1 is aluminum.
13. The composition of claim 11 wherein the first member of Component 2 consists of a member selected from-the group consisting of tocopherol, the acetate, butyrate, caproate, caprylate, caprate and intervening homolog esters thereof, and a succinate, citrate or malate ester thereof.
14. The composition of claim 13 wherein the first member of Component 2 consists of tocopheryl acetate.
15. The composition of claim 9 comprising calcium stearate and tocopherol acetate in addition to the block copolymer of ethylene oxide and propylene oxide.
16. The composition of claim 15 comprising anti-infective agent.
17. The composition of claim 1 wherein Component 1 consists of calcium stearate, and the first member of Component 2 consists of tocopheryl acetate.
18. A package comprising the composition of claim 1 wherein said composition is amorphous or in a generally rounded form or in a generally parallelepiped form, wherein said composition is sealed in an aseptic barrier package, and is sterile or sterilizable.
19. The package of claim 18 wherein the package comprises a plunger or applicator whereby said composition is expellable from said package by the application of mechanical pressure applied to the plunger or applicator.
20. The package of claim 18 wherein the package comprises a squeezable, deformable tube having an openable exit port whereby said composition is expellable from said tube by the application of mechanical pressure thereto.
21. The composition of claim 18 wherein said composition is sterile.
22. A method for mechanically controlling the bleeding of bone which comprises applying an effective amount of the composition of claim 1 , to the affected area.