SPHERICAL FORMS OF CROSS-LINKED HYALURONIC ACID AND METHODS OF USE THEREOF
This disclosure relates generally to spherical forms comprising cross-linked hyaluronic acid, methods of making such spherical forms and using thereof, for example, in aesthetic applications (e.g., facial contouring, soft tissue augmentation products) and the like.
1 . A spherical form for treating skin, the spherical form comprising substantially cross-linked hyaluronic acid.
2 . The spherical form of claim 1 , wherein the hyaluronic acid is substantially cross-linked with at least about 15 mole % of a butanediol diglycidyl ether (BDDE) derivative relative to the repeating disaccharide unit of the hyaluronic acid, and at least about 5% noncross-linked hyaluronic acid relative to the weight of total hyaluronic acid solids.
3 . The spherical form of claim 1 , wherein the substantially cross-linked hyaluronic acid is cross-linked with from about 15 mole % to about 25 mole % of the BDDE derivative.
4 . The spherical form of claim 1 , wherein the substantially cross-linked hyaluronic acid is cross-linked with from about 17 mole % to about 20 mole % of the BDDE derivative.
5 . The spherical form of claim 1 , wherein the substantially cross-linked hyaluronic acid is cross-linked with at least about 18 weight % of the BDDE derivative relative to the weight of the cross-linked hyaluronic acid.
6 . The spherical form of claim 1 , wherein the cross-linked hyaluronic acid is present in an amount of from about 60 weight % to about 90 weight % based on the total weight of the spherical form excluding moisture.
7 . The spherical form of claim 1 , wherein the cross-linked hyaluronic acid is present in an amount of from about 70 weight % to about 80 weight % based on the total weight of the spherical form excluding moisture.
8 . The spherical form of claim 1 , wherein the noncross-linked hyaluronic acid is present in an amount of from about 10 weight % to about 40 weight % based on the total weight of the spherical form excluding moisture.
9 . The spherical form of claim 1 , wherein the noncross-linked hyaluronic acid is present in an amount of from about 15 weight % to about 25 weight % based on the total weight of the spherical form excluding moisture.
10 . The spherical form of claim 1 , wherein the spherical form has a diameter of at least about 0.003 inches.
11 . The spherical form of claim 1 , wherein the spherical form has a diameter of from about 0.003 inches to about 0.05 inches.
12 . The spherical form of claim 1 , wherein the spherical form has a diameter of from about 0.004 inches to about 0.03 inches.
13 . The spherical form of claim 1 , wherein the spherical form has a diameter of from about 0.020 inches to about 0.025 inches.
14 . The spherical form of claim 1 , wherein the spherical form is formed by fragmenting and abrading a thread form.
15 . A method of treating a wrinkle or performing soft tissue augmentation, in a treatment location of a patient in need thereof, said method comprising;
a) inserting a plurality of spherical forms into skin or subcutaneous space of the treatment location, thereby treating the wrinkle or providing the soft tissue augmentation.
16 . The method of claim 15 , wherein step a) is performed at least 2 or more times in the treatment location.
17 . The method of claim 15 , further comprising hydrating said plurality of spherical forms.
18 . The method of claim 15 , wherein the treatment location is selected from the lips, the nasolabial fold, and the tear trough.
19 . A kit of parts for use in treating a wrinkle or performing soft tissue augmentation in a patent, said kit comprising said plurality of spherical forms of claim 1 .
20 . The kit of claim 17 , further comprising a means for delivery of said plurality of spherical forms to a patient.