Process for making controlled release medical implant products

Abstract

A method (and the resulting product) of making a medical implant device for releasing self-contained drugs on a controlled basis wherein the method utilizes, at least in part, computer-controlled 3-D printing equipment to deposit via nozzles portions of one or more layers of the medical implant product. The implant has an outer impervious coating, an inner matrix core, an opening and an optional bonding layer.

We claim: 
     
         1 . A multi-step method of making a mammalian subcutaneous medical implant for releasing self-contained drugs on a controlled basis over at least a 3 day period wherein the method comprises depositing at least portions of one or more individual layers of the implant by at least one computer controlled 3-D printer. 
     
     
         2 . A method according to  claim 1 , wherein the step of depositing portions of one or more individual layers of the implant is practiced such that the implant comprises at least (i) one coating, (ii) one drug-containing core and (iii) one opening. 
     
     
         3 . A method according to  claim 2 , wherein the implant comprises more than one drug material. 
     
     
         4 . A method according to  claim 2 , wherein the implant includes a binding material to enhance adhesion between the coating and core and where the method includes depositing at least a portion of the binding material by a 3-D printer. 
     
     
         5 . A method according to  claim 4 , wherein the coating or optional binding material creates an impermeable layer so that the controlled release of the self-contained drug materials is limited to one or more openings. 
     
     
         6 . A method according to  claim 1 , wherein at least a portion of the 3-D printing method is performed within an enclosed chamber. 
     
     
         7 . A method according to  claim 1 , wherein the implant is formed, at least in part, by the use of more than one 3-D printers each having a multiple nozzle array. 
     
     
         8 . A method according to  claim 7 , wherein the 3-D printer nozzle arrays deposit more than one type of material during formation of at least one layer of the implant. 
     
     
         9 . A method according to  claim 7 , wherein at least a part of one of the printer nozzle arrays is capable of depositing more than one type of material to form the implant. 
     
     
         10 . A method according to  claim 1 , wherein at least a portion of one or more layers are removed. 
     
     
         11 . A method according to  claim 1 , wherein the steps include at least one 3-D printing step and at least one non-3-D printing step. 
     
     
         12 . A method according to  claim 1  wherein at least a portion of one layer of the matrix core is created by 3-D printing. 
     
     
         13 . A method according to  claim 1 , wherein the first step in the process is to supply a sheet of prefabricated coating material. 
     
     
         14 . A method according to  claim 1 , wherein at least one of the individual 3-D printer layers is thicker than about 0.01 mm. 
     
     
         15 . A method according to  claim 1 , wherein a matrix core layer is created, in whole or in part, within a separate chamber. 
     
     
         16 . A method according to  claim 6 , wherein at least one 3-D nozzle print array is stationary. 
     
     
         17 . A method according to  claim 6 , wherein at least one 3-D nozzle printer array is non-stationary. 
     
     
         18 . A method according to  claim 2 , wherein the opening is created at least in part during a 3-D printing step. 
     
     
         19 . A method according to  claim 18 , wherein the opening is created at least partially from rapidly biodegradable materials. 
     
     
         20 . A method according to  claim 1 , wherein at least one layer is formed with two or more materials. 
     
     
         21 . A method according to  claim 1 , wherein more than one implants are formed at the same time and where one or more layers of each of the implants are created at least in part by 3-D printing. 
     
     
         22 . A method according to  claim 21 , wherein at least one process step involves at separation of more than one implants at least in part by cutting, lasers, etching or mechanical devices. 
     
     
         23 . A method according to  claim 22 , wherein the separation step results in the creation of a large number of individual implants to increase yield or to reduce manufacturing expense. 
     
     
         24 . A method according to  claim 1 , wherein at least three individual layers are created by a 3-D printing process step. 
     
     
         25 . A method according to  claim 1 , wherein the implant contains a radio opaque marker and at least a portion of the marker is made by 3-D printing. 
     
     
         26 . A subcutaneous medical implant for releasing self-contained drugs on a controlled basis over at least a 3 day period wherein its method of manufacture involves, at least in part, the use of at least one computer controlled 3-D printer to deposit portions of one or more individual layers of the implant. 
     
     
         27 . An implant according to  claim 26 , wherein at least a portion of the 3-D printing method of manufacture is performed within an enclosed chamber. 
     
     
         28 . An implant according to  claim 26 , wherein the implant is formed, at least in part, by the use of more than one 3-D printers each having a multiple nozzle array. 
     
     
         29 . An implant according to  claim 28 , wherein the 3-D printer nozzle arrays deposit more than one type of material during formation of at least one layer of the implant. 
     
     
         30 . An implant according to  claim 28 , wherein at least a part of one of the printer nozzle arrays is capable of depositing more than one type of material to form the implant. 
     
     
         31 . An implant according to  claim 26 , wherein at least a portion of one or more layers are removed. 
     
     
         32 . An implant according to  claim 26 , wherein the process steps include at least one 3-D printing step and at least one non-3-D printing step. 
     
     
         33 . An implant according to  claim 26  wherein at least a portion of one layer of the matrix core is created by 3-D printing. 
     
     
         34 . An implant according to  claim 26 , wherein at least one layer of the implant is a sheet of prefabricated coating material. 
     
     
         35 . An implant according to  claim 27 , wherein an opening is created at least in part during a 3-D printing step. 
     
     
         36 . An implant according to  claim 26 , wherein at least one layer of the implant is formed with two or more materials. 
     
     
         37 . An implant according to  claim 26 , wherein more than one implants are formed at the same time and where one or more layers of each of the implants are created at least in part by 3-D printing. 
     
     
         38 . An implant according to  claim 37 , wherein separation of the implants involves cutting, lasers, etching or mechanical devices. 
     
     
         39 . An implant according to  claim 38 , wherein the separation results in the creation of a large number of individual implants to increase yield or to reduce manufacturing expense. 
     
     
         40 . An implant according to  claim 26 , wherein at least three individual layers of the implant are created by a 3-D printing process step.