Modeling devices used in guided bone and tissue regeneration

Abstract

This disclosure describes manufacturing of a device configured to guide bone and tissue regeneration for a bone defect. A method may include receiving a three-dimensional digital model or scan representing an anatomical feature to be repaired, generating a simulated membrane using the three-dimensional model, the simulated membrane being configured to cover the anatomical feature to be repaired, generating a digital two-dimensional flattened version of the simulated membrane, and generating code or instructions configured to cause a three-dimensional printer or milling device to produce a trimming guide that includes an opening corresponding to the flattened version of the simulated membrane and that further includes a cut-out configured to hold a premanufactured membrane. The trimming guide may be operative as a guide for marking or cutting the premanufactured membrane through the opening while the premanufactured membrane is held in the cut-out.

1 . A device configured for repair of a bone defect, comprising:
 a first layer configured to contact bone, the first layer comprising expanded polytetrafluoroethylene (ePTFE) cut according to a first template;   a second layer comprising high density, cell occlusive polytetrafluoroethylene (PTFE) cut according to the first template and configured to substantially prevent fibrous connective tissue from growing into the bone defect; and   one or more holes drilled through the device in accordance with a second template and configured to receive fasteners for fixing the device to bone adjacent to an anatomical feature to be repaired,   wherein the first template and the second template are generated by a processor that is configured to:
 generate a three-dimensional digital model representing an anatomical feature from a scan of the anatomical feature, wherein the anatomical feature includes a defect to be repaired; 
 modify the three-dimensional digital model in a manner that simulates the effect of adding a packing material to the defect; 
 generate a simulated membrane using the three-dimensional model or scan, the simulated membrane being configured to cover the anatomical feature to be repaired and to cover the packing material; 
 producing the first template using the simulated membrane; and 
 configuring the second template to identify location of one or more holes in the device to be used for fixing the device to bone adjacent to the anatomical feature to be repaired. 
   
     
     
         2 . The device of  claim 1 , wherein the first template comprises a trimming guide. 
     
     
         3 . The device of  claim 2 , wherein processor is further configured to:
 generate a digital two-dimensional flattened version of the simulated membrane; and   cause the trimming guide to be 3D printed or milled to include an opening corresponding to the flattened version of the simulated membrane.   
     
     
         4 . The device of  claim 1 , wherein the first layer and the second layer are joined to obtain the device. 
     
     
         5 . The device of  claim 1 , wherein the device comprises at least one layer having collagen, bioresorbable polymer, animal tissue, or human tissue that is cut according to the first template. 
     
     
         6 . The device of  claim 1 , wherein one or more of a size, a density, or a spacing defined by the first template is based on one or more characteristics of a material included in the device, a thickness of the device, or a size of the device. 
     
     
         7 . The device of  claim 1 , further comprising:
 a reinforcement binder configured to couple the device with the bone adjacent to the anatomical feature to be repaired, the reinforcement binder having a plurality of elongated members extending from a junction, including a first elongated member having a free end that extends away from the junction.   
     
     
         8 . The device of  claim 7 , wherein the reinforcement binder is deployed between the first layer and the second layer. 
     
     
         9 . A method for manufacturing a device configured to guide bone and tissue regeneration, comprising:
 generating a three-dimensional digital model representing an anatomical feature from a scan of the anatomical feature, wherein the anatomical feature includes a defect to be repaired;   modifying the three-dimensional digital model in a manner that simulates the effect of adding a packing material to the defect;   generating a simulated membrane using the three-dimensional model or scan, the simulated membrane being configured to cover the anatomical feature to be repaired and to cover the packing material;   manufacturing the device to match physical structure of the simulated membrane; and   generating a drilling template for drilling one or more holes in the device to be used for fixing the device to bone adjacent to the anatomical feature to be repaired.   
     
     
         10 . The method of  claim 9 , wherein manufacturing the device comprises:
 producing a template corresponding to the simulated membrane; and   cutting a premanufactured membrane according to the template to obtain the device.   
     
     
         11 . The method of  claim 9 , further comprising:
 generating a digital two-dimensional flattened version of the simulated membrane;   producing a 3D printed or milled trimming guide that includes an opening corresponding to the flattened version of the simulated membrane; and   using the trimming guide to trim a premanufactured membrane.   
     
     
         12 . The method of  claim 11 , further comprising:
 selecting the premanufactured membrane from a catalog of membranes based on fit to size and shape of the flattened version of the simulated membrane;   providing a cut-out in the trimming guide, wherein the cut-out is configured to hold the premanufactured membrane; and   marking or cutting the premanufactured membrane through the opening while the premanufactured membrane is held in the cut-out.   
     
     
         13 . The method of  claim 11 , wherein manufacturing the device comprises:
 applying the premanufactured membrane to the anatomical feature to be repaired after the premanufactured membrane is trimmed,   wherein applying the premanufactured membrane to the anatomical feature to be repaired causes the premanufactured membrane to adopt a three-dimensional shape corresponding to the simulated membrane.   
     
     
         14 . The method of  claim 9 , wherein manufacturing the device comprises:
 printing or cutting at least one layer of material using template information derived from the simulated membrane; and   joining the at least one layer of material to one or more other layers of material to obtain the device.   
     
     
         15 . The method of  claim 9 , wherein the device comprises a first layer configured to contact bone, the first layer comprising expanded polytetrafluoroethylene (ePTFE) and a second layer comprising high density, cell occlusive polytetrafluoroethylene (PTFE) configured to substantially prevent fibrous connective tissue from growing into a bone defect. 
     
     
         16 . The method of  claim 9 , wherein the device comprises at least one layer having collagen, bioresorbable polymer, animal tissue, or human tissue. 
     
     
         17 . The method of  claim 9 , wherein one or more of a size, a density, or a spacing defined by the simulated membrane is calculated by a modeling system based on one or more characteristics of a material included in the device, a thickness of the device, or a size of the device. 
     
     
         18 . The method of  claim 9 , further comprising:
 attaching the device to the bone adjacent to the anatomical feature to be repaired using a reinforcement binder.   
     
     
         19 . The method of  claim 18 , wherein the reinforcement binder comprises:
 a plurality of elongated members extending from a junction, including a first elongated member having a free end that extends away from the junction; and   a hole formed in the first elongated member, the hole configured to receive a fastener that passes through a first layer of the device and a second layer of the device and that holds the device in place at a bone defect, wherein the fastener comprises a pin, tack, suture, or screw.   
     
     
         20 . The method of  claim 18 , wherein the reinforcement binder is a titanium reinforcement binder and is deployed between a first layer of the device and a second layer of the device.