Universal bioabsorbable nasal implant kit

Abstract

Novel bioabsorbable, universal kits used to form nasal implants are disclosed. The implants are useful in rhinoplasty and nasal reconstruction surgical procedures. The kit devices have a universal configuration and can be converted by the surgeon in the field into one or more individual nasal implant devices having different configurations and applications. The kits may have outlines of nasal implants thereon.

We claim: 
     
         1 . A biocompatible, bioabsorbable polymeric nasal kit device, comprising:
 a first wall member having an inner surface, an outer surface, a free top side, a bottom side, opposed lateral sides, and a first height;   a second wall member having in inner surface, an outer surface, a free top side, a bottom side, opposed lateral sides, and a second height, wherein the first height is greater than the second height;   a spine member having an inner surface and an outer surface, wherein the bottom sides of the first and second wall members are connected to the spine member such that there is a channel defined by the inner surfaces of the first wall member, the second wall member and the spine member; and,   an outline of a nasal implant contained on the kit device,   wherein the kit device comprises a bioabsorbable polymer.   
     
     
         2 . The kit device of  claim 1 , additionally containing a plurality of openings through one or more of the wall members. 
     
     
         3 . The kit device of  claim 1 , wherein the outline comprises a printed image. 
     
     
         4 . The kit device of  claim 1 , wherein the outline comprises a score line. 
     
     
         5 . The kit device of  claim 1 , wherein the outline comprises a thermally formed line. 
     
     
         6 . The kit device of  claim 1 , wherein the outline defines a plate member. 
     
     
         7 . The kit device of  claim 1 , wherein the outline defines a spreader graft device. 
     
     
         8 . The kit device of  claim 1 , wherein the outline defines a columellar strut. 
     
     
         9 . The kit device of  claim 1 , wherein the outline defines a septal extension graft device. 
     
     
         10 . The kit device of  claim 1 , wherein the outline defines a nasal implant selected from the group consisting of spreader graft members, plates, columellar struts, septal extension grafts, and combinations thereof. 
     
     
         11 . The kit device of  claim 1 , wherein the spine member has a curved configuration. 
     
     
         12 . The kit device of  claim 1 , wherein at least one of the first and second plate members can partially rotate inwardly or outwardly with respect to the spine member. 
     
     
         13 . The kit device of  claim 1 , wherein the bioabsorbable polymer is selected from the group consisting of polydioxanone, polyglycolide lactide-rich copolymers, and blends thereof. 
     
     
         14 . The kit device of  claim 1 , wherein the outline is printed onto the device. 
     
     
         15 . The kit device of  claim 1 , wherein the outlined is laser cut into the device. 
     
     
         16 . The kit device of  claim 1 , wherein the outline is mechanically cut into the device. 
     
     
         17 . The kit device of  claim 1 , wherein the bottom sides of the wall members are connected to the spine member by a process selected from the group consisting of welding, gluing, and mechanical fixation. 
     
     
         18 . A biocompatible, bioabsorbable polymeric nasal kit device, comprising:
 a first wall member having an inner surface, an outer surface, a free top side, a bottom side, opposed lateral ends, and a first height;   a second wall member having in inner surface, an outer surface, a free top side, a bottom side, opposed lateral sides and a second height, wherein the first height is greater than the second height;   a spine member having an inner surface and an outer surface, wherein the bottom ends of the first and second wall members are connected to the spine member such that there is a channel defined by the inner surfaces of the first wall member, the second wall member and the spine member,   wherein the kit device comprises a bioabsorbable polymer.   
     
     
         19 . The device of  claim 18 , additionally comprising an outline of a nasal implant contained on the kit device. 
     
     
         20 . The kit device of  claim 18 , additionally containing a plurality of openings through one or more of the wall members. 
     
     
         21 . The kit device of  claim 19 , wherein the outline comprises a printed image. 
     
     
         22 . The kit device of  claim 19 , wherein the outline comprises a score line. 
     
     
         23 . The kit device of  claim 19 , wherein the outline comprises a thermally formed line. 
     
     
         24 . The kit device of  claim 19 , wherein the outline defines a plate member. 
     
     
         25 . The kit device of  claim 19 , wherein the outline defines a spreader graft member device. 
     
     
         26 . The kit device of  claim 19 , wherein the outline defines a columellar strut. 
     
     
         27 . The kit device of  claim 19 , wherein the outline defines a septal extension graft device. 
     
     
         28 . The kit device of  claim 19 , wherein the outline defines a nasal implant selected from the group consisting of spreader graft members, plates, columellar struts, septal extension grafts, and combinations thereof. 
     
     
         29 . The kit device of  claim 18 , wherein the spine member has a curved configuration. 
     
     
         30 . The kit device of  claim 18 , wherein at least one of the first and second plate members can partially rotate inwardly or outwardly with respect to the spine member. 
     
     
         31 . The kit device of  claim 29 , wherein the bioabsorbable polymer is selected from the group consisting of polydioxanone, polyglycolide lactide-rich copolymers, and blends thereof. 
     
     
         32 . The kit device of  claim 19 , wherein the outline is printed onto the device. 
     
     
         33 . The kit device of  claim 19 , wherein the outlined is laser cut into the device. 
     
     
         34 . The kit device of  claim 19 , wherein the outline is mechanically cut into the device. 
     
     
         35 . A method of making a bioabsorbable, polymeric nasal implant, comprising the steps of:
 A. providing a bioabsorbable, polymeric universal kit comprising:   a first wall member having an inner surface, an outer surface, a free top side, a bottom side, opposed lateral sides and a first height;   a second wall member having an inner surface, an outer surface, a top side, a bottom side, opposed lateral sides and a second height, wherein the first height is greater than the second height;   a spine member having an inner surface and an outer surface, a first bottom end and a second bottom end, wherein the bottom sides of the first wall member and the second wall member are connected to the spine such that there is a channel defined by the inner surfaces of the first plate member, the second plate member and the spine member, wherein the kit comprises a bioabsorbable polymer; and,   B. cutting the kit device to form a nasal implant.   
     
     
         36 . The method of  claim 35 , wherein the kit additionally comprises an outline of a nasal implant to serve as a cutting guide. 
     
     
         37 . A method of performing a nasal reconstructive procedure, comprising:
 A. providing a bioabsorbable polymeric universal kit comprising:   a first wall member having an inner surface, an outer surface, a free top side, a bottom side, opposed lateral sides and a first height;   a second wall member having in inner surface, an outer surface, a top side, a bottom side, opposed lateral sides and a second height, wherein the first height is greater than the second height;   a spine member having an inner surface and an outer surface, a first bottom end and a second bottom end, wherein the bottom sides of the first wall member and the second wall member are connected to the spine such that there is a channel defined by the inner surfaces of the first plate member, the second plate member and the spine member,   wherein the kit comprises a bioabsorbable polymer;   B. cutting the kit device to form a nasal implant; and,   C. implanting the nasal implant into the nose of a patient.   
     
     
         38 . The method of  claim 37 , wherein the kit additionally comprises an outline of a nasal implant to serve as a cutting guide. 
     
     
         39 . The kit device of  claim 18 , wherein the bottom sides of the wall members are connected to the spine member by a process selected from the group consisting of welding, gluing, and mechanical fixation. 
     
     
         40 . The method of  claim 35 , wherein the bottom sides of the wall members are connected to the spine member by a process selected from the group consisting of welding, gluing, and mechanical fixation. 
     
     
         41 . The method of  claim 37 , wherein the bottom sides of the wall members are connected to the spine member by a process selected from the group consisting of welding, gluing, and mechanical fixation.