Composition and method for post-surgical adhesion reduction with thermo-irreversible gels of polyoxyalkylene polymers and ionic polysaccharides
AssigneeMediventures, Inc.
InventorRaymond L. Henry
Life of this patent
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Abstract
A process and compositons for reducing post-surgical adhesion formation/reformation in mammals following injury to organs situated in mammalian body spaces. Aqueous, thermally reversible gel compositions, preferably at mammalian body fluid pH, comprising a polyoxyalkylene polymer and an ionic polysaccharide are applied to injured areas of the organs situated in body cavities such as, the peritoneal, pelvic, or pleural cavity. The aqueous gels are rendered thermally irreversible upon contact with a counter-ion.
Claims44
A process for reducing post-surgical adhesion formation/reformation following injury to organs situated in mammalian body spaces comprising separating said organs from adjacent mammalian tissue with an effective adhesion reducing amount of a thermally-irreversible aqueous gel composition consisting essentially of water and a mixture of at least one ionic polysaccharide,
- (A) at least one polyoxyalkylene block copolymer of the formula
- Y[(A).sub.n --E--H].sub.x (I)
- wherein A is an oxyalkylene moiety having an oxygen/carbon atom ratio of less that 0.5, x is at least 1, Y is derived from water or an organic compound containing x reactive hydrogen atoms, E is a polyoxyethylene moiety, n has a value such that the average molecular weight of A is at least about 500 to about 900, as determined by the hydroxyl number of an intermediate,
- Y[(A).sub.n --H].sub.x (II)
- and the total average molecular weight of the copolymer is at least about 5000 and
- (B) optionally, a latent form of at least one counter-ion capable of thermo-irreversibly gelling said composition.
A thermally-irreversible, aqueous gel composition for reducing post-surgical adhesion formation/reformation following injury to organs situated in mammalian body spaces, said composition consisting essentially of water, a mixture of at leas tone ionic polysaccharide,
- (A) at least one polyoxyalkylene block copolymer of the formula
- Y[(A).sub.n --E--H].sub.x (I)
- wherein A is a polyoxyalkylene moiety having an oxygen/carbon atom ratio of less than 0.5, x is at least 2, Y is derived from water or an organic compound containing x reactive hydrogen atoms, E is a polyoxyethylene moiety constituting at least about 60% by weight of the copolymer, n has a value such that the average molecular weight of A is at least about 500 to about 900, as determined by the hydroxyl number of an intermediate,
- Y[(A).sub.n--H].sub.x (II)
- and the total average molecular weight of the copolymer is at least about 5000,
- (B) optionally, an additive selected from the group consisting of a humectant, a bactericide, a bacteriostatic agent, an agent to prevent leucocyte migration into an area of surgical injury, a fibrinolytic agent, and mixtures thereof, and
- (C) optionally, a latent form of at least one counter-ion for rendering the mixture thermally-irreversible.
A process for reducing post-surgical adhesion formation/reformation following injury to organs situated in mammalian body spaces comprising separating said organs from adjacent tissue with an effective amount of a thermally- irreversible aqueous gel composition consisting essentially of water and a mixture of at least one ionic polysaccharide, at least one optional counter-ion, present in latent form, at least one surfactant, and at least one polyoxyalkylene polyether, said polyether having a molecular weight of about 10,000 to about 100,000, which is selected from the group consisting of
- (A) polyoxyalkylene polyethers prepared by reacting ethylene oxide and at least one lower alkylene oxide having 3 to 4 carbon atoms with at least one active hydrogen-containing compound having from 3 to 10 carbon atoms and from 3 to 6 active hydrogens to prepare a heteric or block copolymer intermediate and further reacting said copolymer intermediate with at least one alpha-olefin oxide having an average carbon chain length of about 20 to about 45 aliphatic carbon atoms and wherein said alpha-olefin oxide is present in the amount of about 0.3 to 10 percent by weight based upon the total weight of said polyether.
- (B) polyoxyalkylene polyethers prepared by reacting ethylene oxide with at least one active hydrogen-containing compound having from 2 to 10 carbon atoms and from 2 to 6 active hydrogens to prepare a homopolymer intermediate and further reacting said homopolymer with at least one alpha-olefin oxide having an average carbon chain length of about 20 to 45 aliphatic carbon atoms and wherein said alpha-olefin oxide is present in the amount of about 0.3 to 10 percent by weight based on the total weight of said polyether.
A thermally-irreversible aqueous gel composition for reducing post-surgical adhesion formation/reformation following injury to organs situated in mammalian body spaces, said composition consisting essentially of water, a mixture of at least one ionic polysaccharide, at least one surfactant, and at least one polyether having a molecular weight of about 10,000 to about 100,000, which is selected form the group consisting of
- (A) polyoxyalkylene polyethers prepared by reacting ethylene oxide and at least one lower alkylene oxide having 3 to 4 carbon atoms with at least one active hydrogen-containing compound having from 3 to 10 carbon atoms and from 3 to 6 active hydrogens to prepare a heteric or block copolymer intermediate and further reacting said copolymer intermediate with at least one alpha-olefin oxide having an average carbon chain length of about 20 to about 45 aliphatic carbon atoms and wherein said alpha-olefin oxide is present in the amount of about 0.3 to 10 percent by weight based upon the total weight of said polyether and
- () polyoxyalkylene polyethers prepared by reacting ethylene oxide with at least one active hydrogen-containing compound having from 2 to 10 carbon atoms and from 2 to 6 active hydrogens to prepare a homopolymer intermediate and further reacting said homopolymer with at least one alpha-olefin oxide having an average carbon chain length of about 20 to 45 aliphatic carbon atoms and wherein said alpha-olefin oxide is present in the amount of about 0.3 to 10 percent by weight based on the total weight of said polyether and
- (C) optionally, an additive selected from the group consisting of a humectant, a bactericide, a bacteriostatic agent, an agent to prevent leucocyte migration into an area of surgical injury, a fibrinolytic agent, and mixtures thereof, and
- (D) optionally, a latent form of a counter-ion capable of rendering the mixture thermally-irreversible.
Dependencies are inferred from the claim text.