High swell, long-lived hydrogel sealant
First Claim
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1. A kit for preparing a high swell, long-lived sealant comprising:
- a) a first aqueous solution or dispersion comprising at least one highly oxidized polysaccharide containing aldehyde groups, said highly oxidized polysaccharide having a weight-average molecular weight of about 1,000 to about 1,000,000 Daltons and an equivalent weight per aldehyde group of about 65 to about 85 Daltons, wherein said first aqueous solution or dispersion contains said highly oxidized polysaccharide at a concentration of greater than or equal to about 3% but less than 6% by weight; and
b) a second aqueous solution or dispersion comprising at least one water-dispersible, multi-arm amine wherein at least three of the arms are terminated by at least one primary amine group, said multi-arm amine having a number-average molecular weight of about 450 to about 200,000 Daltons, wherein said second aqueous solution or dispersion contains said multi-arm amine at a concentration of about 5% to about 70% by weight;
wherein the high swell, long-lived sealant is formed when(i) the concentration of the highly oxidized polysaccharide in the first aqueous solution or dispersion is equal to or greater than 5 wt % but less than 6 wt %, the equivalent weight per aldehyde group of the highly oxidized polysaccharide is about 80 to about 85 Daltons;
or(ii) the concentration of the highly oxidized polysaccharide in the first aqueous solution or dispersion is equal to or greater than 3 wt % but less than 5 wt %, the equivalent weight per aldehyde group of the highly oxidized polysaccharide is about 65 to about 85 Daltons.
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Abstract
A high swell, long-lived hydrogel sealant formed by reacting a highly oxidized polysaccharide containing aldehyde groups with a multi-arm amine is described. The hydrogel sealant may be particularly suitable for applications requiring high swell and slow degradation, for example, tissue augmentation, both cosmetic and reconstructive; void filling; tissue bulking, for example treatment of urinary incontinence and acid reflux; and embolization. The high swell, long-lived hydrogel sealant may also be useful as a tissue sealant and adhesive, and as an anti-adhesion barrier.
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Citations
20 Claims
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1. A kit for preparing a high swell, long-lived sealant comprising:
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a) a first aqueous solution or dispersion comprising at least one highly oxidized polysaccharide containing aldehyde groups, said highly oxidized polysaccharide having a weight-average molecular weight of about 1,000 to about 1,000,000 Daltons and an equivalent weight per aldehyde group of about 65 to about 85 Daltons, wherein said first aqueous solution or dispersion contains said highly oxidized polysaccharide at a concentration of greater than or equal to about 3% but less than 6% by weight; and b) a second aqueous solution or dispersion comprising at least one water-dispersible, multi-arm amine wherein at least three of the arms are terminated by at least one primary amine group, said multi-arm amine having a number-average molecular weight of about 450 to about 200,000 Daltons, wherein said second aqueous solution or dispersion contains said multi-arm amine at a concentration of about 5% to about 70% by weight; wherein the high swell, long-lived sealant is formed when (i) the concentration of the highly oxidized polysaccharide in the first aqueous solution or dispersion is equal to or greater than 5 wt % but less than 6 wt %, the equivalent weight per aldehyde group of the highly oxidized polysaccharide is about 80 to about 85 Daltons;
or(ii) the concentration of the highly oxidized polysaccharide in the first aqueous solution or dispersion is equal to or greater than 3 wt % but less than 5 wt %, the equivalent weight per aldehyde group of the highly oxidized polysaccharide is about 65 to about 85 Daltons. - View Dependent Claims (2, 3, 4, 5)
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6. A dried hydrogel for preparing a high swell, long-lived sealant, the dried hydrogel formed by a process comprising the steps of:
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a) combining (i) a first solution or dispersion comprising at least one highly oxidized polysaccharide containing aldehyde groups in a first solvent, said oxidized polysaccharide having a weight-average molecular weight of about 1,000 to about 1,000,000 Daltons and an equivalent weight per aldehyde group of about 65 to about 85 Daltons, said first solution or dispersion containing said highly oxidized polysaccharide at a concentration of greater than or equal to about 3% but less than 6% by weight;
with (ii) a second solution or dispersion comprising at least one water-dispersible, multi-arm amine in a second solvent, wherein at least three of the arms of the multi-arm amine are terminated by at least one primary amine group, said multi-arm amine having a number-average molecular weight of about 450 to about 200,000 Daltons, wherein said second solution or dispersion contains said multi-arm amine at a concentration of about 5% to about 70% by weight, to form a hydrogel, wherein the first solvent is either the same as or different from the second solvent; andb) treating the hydrogel to remove at least a portion of said first solvent and said second solvent to form the dried hydrogel; wherein the high swell, long-lived sealant is formed when (i) the concentration of the highly oxidized polysaccharide in the first solution or dispersion is equal to or greater than 5 wt % but less than 6 wt %, the equivalent weight per aldehyde group of the highly oxidized polysaccharide is about 80 to about 85 Daltons;
or(ii) the concentration of the highly oxidized polysaccharide in the first solution or dispersion is equal to or greater than 3 wt % but less than 5 wt %, the equivalent weight per aldehyde group of the highly oxidized polysaccharide is about 65 to about 85 Daltons. - View Dependent Claims (7, 8, 9, 10, 11, 12)
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13. A method for applying a coating comprising a high swell long-lived sealant to an anatomical site on tissue of a living organism comprising:
- applying to the site
(a) a first aqueous solution or dispersion comprising at least one highly oxidized polysaccharide containing aldehyde groups, said highly oxidized polysaccharide having a weight-average molecular weight of about 1,000 to about 1,000,000 Daltons and an equivalent weight per aldehyde group of about 65 to about 85 Daltons, wherein said first aqueous solution or dispersion contains said highly oxidized polysaccharide at a concentration of greater than or equal to about 3% but less than 6% by weight;
followed by (b) a second aqueous solution or dispersion comprising at least one water-dispersible, multi-arm amine wherein at least three of the arms are terminated by at least one primary amine group, said multi-arm amine having a number-average molecular weight of about 450 to about 200,000 Daltons, wherein said second aqueous solution or dispersion contains said multi-arm amine at a concentration of about 5% to about 70% by weight, orapplying (b) followed by (a) and mixing (a) and (b) on the site, or premixing (a) and (b) to form a mixture and applying said mixture to the site; wherein the high swell, long-lived sealant is formed when (i) the concentration of the highly oxidized polysaccharide in the first aqueous solution or dispersion is equal to or greater than 5 wt % but less than 6 wt %, the equivalent weight per aldehyde group of the highly oxidized polysaccharide is about 80 to about 85 Daltons;
or(ii) the concentration of the highly oxidized polysaccharide in the first aqueous solution or dispersion is equal to or greater than 3 wt % but less than 5 wt %, the equivalent weight per aldehyde group of the highly oxidized polysaccharide is about 65 to about 85 Daltons. - View Dependent Claims (14)
- applying to the site
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15. A method for completely or partially blocking or filling a lumen or void within the body of humans or animals comprising the steps of:
- applying into said lumen or void (a) a first aqueous solution or dispersion comprising at least one highly oxidized polysaccharide containing aldehyde groups, said highly oxidized polysaccharide having a weight-average molecular weight of about 1,000 to about 1,000,000 Daltons and an equivalent weight per aldehyde group of about 65 to about 85 Daltons, wherein said first aqueous solution or dispersion contains said highly oxidized polysaccharide at a concentration of greater than or equal to about 3% but less than 6% by weight;
followed by (b) a second aqueous solution or dispersion comprising at least one water-dispersible, multi-arm amine wherein at least three of the arms are terminated by at least one primary amine group, said multi-arm amine having a number-average molecular weight of about 450 to about 200,000 Daltons, wherein said second aqueous solution or dispersion contains said multi-arm amine at a concentration of about 5% to about 70% by weight, orapplying (b) followed by (a), or applying (a) and (b) simultaneously or premixing (a) and (b) to form a mixture and applying said mixture to the lumen or void; wherein a high swell, long-lived sealant is formed when (i) the concentration of the highly oxidized polysaccharide in the first aqueous solution or dispersion is equal to or greater than 5 wt % but less than 6 wt %, the equivalent weight per aldehyde group of the highly oxidized polysaccharide is about 80 to about 85 Daltons;
or(ii) the concentration of the highly oxidized polysaccharide in the first aqueous solution or dispersion is equal to or greater than 3 wt % but less than 5 wt %, the equivalent weight per aldehyde group of the highly oxidized polysaccharide is about 65 to about 85 Daltons. - View Dependent Claims (16)
- applying into said lumen or void (a) a first aqueous solution or dispersion comprising at least one highly oxidized polysaccharide containing aldehyde groups, said highly oxidized polysaccharide having a weight-average molecular weight of about 1,000 to about 1,000,000 Daltons and an equivalent weight per aldehyde group of about 65 to about 85 Daltons, wherein said first aqueous solution or dispersion contains said highly oxidized polysaccharide at a concentration of greater than or equal to about 3% but less than 6% by weight;
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17. A composition comprising the reaction product of:
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a) a first aqueous solution or dispersion comprising at least one highly oxidized polysaccharide containing aldehyde groups, said highly oxidized polysaccharide having a weight-average molecular weight of about 1,000 to about 1,000,000 Daltons and an equivalent weight per aldehyde group of about 65 to about 85 Daltons, wherein said first aqueous solution or dispersion contains said highly oxidized polysaccharide at a concentration of greater than or equal to about 3% but less than 6% by weight; and b) a second aqueous solution or dispersion comprising at least one water-dispersible, multi-arm amine wherein at least three of the arms are terminated by at least one primary amine group, said multi-arm amine having a number-average molecular weight of about 450 to about 200,000 Daltons, wherein said second aqueous solution or dispersion contains said multi-arm amine at a concentration of about 5% to about 70% by weight; wherein a high swell, long-lived sealant is formed when (i) the concentration of the highly oxidized polysaccharide in the first aqueous solution or dispersion is equal to or greater than 5 wt % but less than 6 wt %, the equivalent weight per aldehyde group of the highly oxidized polysaccharide is about 80 to about 85 Daltons;
or(ii) the concentration of the highly oxidized polysaccharide in the first aqueous solution or dispersion is equal to or greater than 3 wt % but less than 5 wt %, the equivalent weight per aldehyde group of the highly oxidized polysaccharide is about 65 to about 85 Daltons. - View Dependent Claims (18, 19, 20)
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Specification