Implants for sculpting, augmenting or correcting facial features such as the chin

Abstract

An injectable device, comprising a hyaluronic acid-based composition, useful for long lasting facial sculpting and correction of facial features, for example, for augmenting and shaping the profile, including for example, the chin, jawline or the nose, in a human being is provided. Methods of treatment are also provided.

1 . A sterile composition, implantable subdermally or supraperiostially into the chin area, jawline or nose of a patient in need thereof, the composition comprising a crosslinked hyaluronic acid (HA) crosslinked with 1,4-butanediol diglycidyl ether (BDDE);
 wherein a HA concentration of the composition is greater than 20 mg/g;   wherein the HA used for crosslinking is made with a mixture of low molecular weight hyaluronic acid and high molecular weight hyaluronic acid;   wherein the HA used for crosslinking is a mixture containing at least 50% by weight of low molecular weight HA, based on a total weight of the HA;   wherein the composition has an elastic modulus between about 500 Pa and about 900 Pa at 5 Hz;   wherein the composition has a cohesivity above 60 gmf; and   wherein the composition exhibits an extrusion force between about 4N and about 15N at 13 mm/min using a 1 mL COC syringe and a 27G×13 mm needle.   
     
     
         2 . The composition of  claim 1 , wherein the HA concentration is at least about 22.5 mg/g. 
     
     
         3 . The composition of  claim 1 , wherein the HA concentration is about 25 mg/g. 
     
     
         4 . The composition of  claim 1 , wherein the HA concentration is about 27.5 mg/g. 
     
     
         5 . The composition of  claim 1 , wherein the HA used for crosslinking is a mixture containing at least 70% by weight of low molecular weight HA based on the total weight of the HA. 
     
     
         6 . The composition of  claim 1 , wherein the HA used for crosslinking is a mixture containing about 90% by weight of low molecular weight HA and about 10% by weight of high molecular weight HA, based on the total weight of the HA. 
     
     
         7 . The composition of  claim 1 , wherein the cohesivity is between about 60 gmf and about 200 gmf. 
     
     
         8 . The composition of  claim 1 , wherein the cohesivity is between about 60 gmf and about 100 gmf. 
     
     
         9 . The composition of  claim 1 , wherein the extrusion force is between about 7N and about 12N at 13 mm/min using a 1 mL COC syringe and a 27G×13 mm needle. 
     
     
         10 . The composition of  claim 1 , wherein the extrusion force is between about 8N and about 10N at 13 mm/min using a 1 mL COC syringe and a 27G×13 mm needle. 
     
     
         11 . The composition of  claim 1 , wherein the composition further includes an anesthetic agent. 
     
     
         12 . The composition of  claim 1 , wherein the composition further includes lidocaine hydrochloride. 
     
     
         13 . The composition of  claim 1 , wherein the composition further includes about 0.3% by weight lidocaine hydrochloride, based on the total weight of the composition. 
     
     
         14 . The composition of  claim 1 , wherein the HA has a degree of crosslinking of between about 4% and about 10%. 
     
     
         15 . The composition of  claim 1 , wherein the HA has a degree of crosslinking of about 4%. 
     
     
         16 . The composition of  claim 1 , wherein the HA has a degree of crosslinking of about 6%. 
     
     
         17 . The composition of  claim 1 , wherein the HA has a degree of crosslinking of about 8%. 
     
     
         18 . The composition of  claim 1 , wherein the HA has a degree of crosslinking of about 10% or about 6.5%. 
     
     
         19 . The composition of  claim 1 , wherein the composition comprises about 25 mg of crosslinked HA and 3 mg of lidocaine in a phosphate buffer pH 7.2 q.s. 1 mL, and wherein the crosslinked HA has a degree of crosslinking of about 6.5%. 
     
     
         20 . A method for correcting chin retrusion in a patient comprising:
 supraperiostally administering into at least one treatment area of the face of the patient, an effective amount of a composition comprising BDDE-crosslinked hyaluronic acid (HA), the HA having a degree of crosslinking of about 6.5%, and having a HA concentration of greater than 20 mg/g, wherein the HA used for crosslinking is a mixture containing at least 50% by weight of low molecular weight HA, based on a total weight of the HA; the treatment area being selected from the group consisting of the pogonion, the mentum, the left pre-jowl sulcus, the right pre-jowl sulcus, and the sublabial crease.   
     
     
         21 . The method of  claim 20  wherein, prior to the administering, the patient has a G-Sn-Pog angle of less than about 165° based on calculations of facial angle derived from digital images of the patient. 
     
     
         22 . The method of  claim 20 , wherein the administering results in the patient having an increased G-Sn-Pog angle. 
     
     
         23 . The method of  claim 20 , wherein the patient has an increased G-Sn-Pog angle for a period of time in the range of about 9 months to about 24 months after the step of administering. 
     
     
         24 . The method of  claim 20 , wherein the patient has an increased G-Sn-Pog angle for at least about 6 months after the step of administering. 
     
     
         25 . The method of  claim 20 , wherein the patient has an increased G-Sn-Pog angle for at least about 9 months after the step of administering. 
     
     
         26 . The method of  claim 20 , wherein the patient has an increased G-Sn-Pog angle for at least about 12 months after the step of administering. 
     
     
         27 . The method of  claim 20 , wherein the patient has an increased G-Sn-Pog angle for at least about 18 months after the step of administering. 
     
     
         28 . The method of  claim 20 , wherein the patient has a G-Sn-Pog angle of about 169° or greater after the step of administering. 
     
     
         29 . The method of  claim 20 , wherein:
 the HA concentration of the composition is about 25 mg/g,   wherein the HA used for crosslinking the composition is made with about 90% by weight of low molecular weight hyaluronic acid and about 10% by weight of high molecular weight hyaluronic acid, based on the total weight of the HA;   wherein the composition has an elastic modulus comprised between about 500 Pa and about 800 Pa at 5 Hz;   wherein the composition has a cohesivity between about 60 gmf and 100 gmf; and   wherein the composition has an extrusion force between about 8N and about 10N at 13 mm/min using a 1 mL COC syringe and a 27G×13 mm needle.   
     
     
         30 . A method of creating or restoring volume to the chin or jaw of a patient, the method comprising injecting a sterile composition, subdermally or supraperiostially, into the chin area or jawline of the patient in need thereof, the composition comprising a crosslinked hyaluronic acid (HA) crosslinked with 1,4-butanediol diglycidyl ether (BDDE) and wherein the HA used for crosslinking is a mixture containing at least 50% by weight of low molecular weight HA, based on a total weight of the HA;
 wherein the composition has an elastic modulus between about 500 Pa and about 800 Pa at 5 Hz;   wherein the composition has a cohesivity between about 60 gmf and 100 gmf; and   wherein the method adds volume to the chin or jawline of the patient for a period of time in the range of about 9 months to about 24 months after injection of the composition into the chin or jawline of the patient.   
     
     
         31 . The method of  claim 30  wherein the composition has an extrusion force between about 8N and about 10N at 13 mm/min using a 1 mL COC syringe and a 27G×13 mm needle. 
     
     
         32 . The method of  claim 30 , wherein the HA has a degree of crosslinking of between about 4% and about 12%. 
     
     
         33 . The method of  claim 30 , wherein the HA has a degree of crosslinking of about 6%. 
     
     
         34 . The method of  claim 30 , wherein the HA has a degree of crosslinking of about 8%. 
     
     
         35 . The method of  claim 30 , wherein the HA has a degree of crosslinking of about 10%. 
     
     
         36 . The method of  claim 30 , wherein the HA has a degree of crosslinking of about 6.5%. 
     
     
         37 . The method of  claim 30 , wherein the HA has a degree of crosslinking of about 8.5%. 
     
     
         38 . The method of  claim 30 , wherein the HA has a degree of crosslinking of about 10.5%. 
     
     
         39 . A kit, comprising the composition according to  claim 1 , prefilled in a single-use syringe, and at least one single-use needle. 
     
     
         40 . A method for facial sculpturing, such as for augmenting, correcting, restoring or creating volume in the chin and jaw area, in a patient comprising:
 subcutaneously and/or supraperiosteally administering into at least one treatment area of the face of the patient, an effective amount of the composition of  claim 1  by injection of said composition;   wherein the treatment area is selected from the group consisting of the pogonion, the mentum, the left pre-jowl sulcus, the right pre-jowl sulcus, and the sublabial (mental) crease.   
     
     
         41 . The method of  claim 40 , wherein the composition is injected using a 1 mL COC syringe and a fine gauge needle between about 18G and about 40G. 
     
     
         42 . The method of  claim 40 , wherein the composition is injected in an injection volume of less than 4.0 mL for a single treatment area at any treatment session. 
     
     
         43 . The method of  claim 40 , wherein the composition is injected in a maximum total volume of less than about 4.0 mL for initial and possible top-up treatments combined. 
     
     
         44 . The method of  claim 40 , wherein the pogonion is injected supraperiosteally using multiple small boluses, wherein the mentum is injected supraperiosteally using multiple small boluses, wherein the left and/or right pre jowl sulci is injected using a deep subcutaneous fanning technique, wherein the sublabial (mental) crease is injected using linear, retrograde or anterograde superficial subcutaneous threading. 
     
     
         45 . The method of  claim 40 , further comprising massaging the treatment area of the patient's face, after administering is completed, to assure that the injected composition conforms to a contour of surrounding tissues. 
     
     
         46 . The method of  claim 40 , further comprising, prior to administering said composition, disinfecting the treatment area.