Ear tissue scaffold implant for auricular tissue reconstruction

Abstract

Ear implants for auricular tissue reconstruction in a patient are provided. The ear implant may be a tissue scaffold multicomponent assembly for reconstruction of auricular tissue. Thus, the assembly may include both a first and a second tissue scaffold component. Each comprises a biocompatible polymeric material having a plurality of open pores configured to support cell growth. The first tissue scaffold component defines a central void region and at least a portion of an outer ear framework of the patient after implantation. The second tissue scaffold component defines a base portion. After implantation into the patient, the second tissue scaffold component seats within the central void region of the first tissue scaffold component, so that the second tissue scaffold component is secured to the first tissue scaffold component. Methods for reconstructing auricular tissue in a patient using such ear implant tissue scaffolds are also provided.

What is claimed is: 
     
         1 . An implant for reconstruction of auricular tissue in a patient, the implant comprising:
 a tissue scaffold component comprising a biocompatible polymeric material having a plurality of open pores and that defines a portion of the patient's auricle of an ear,   wherein the plurality of open pores includes at least one first open pore having a first diameter and a plurality of second open pores having a second average diameter less than the first diameter,   wherein the at least one first open pore defines a hollow feature configured to receive a tissue sample, and the plurality of second open pores is distributed throughout a body of the tissue scaffold component and is configured to support cell growth, and the tissue scaffold component has at least a first region that is configured to define at least a portion of an outer ear framework of the patient's auricle after implantation.   
     
     
         2 . The implant of  claim 1 , wherein the tissue sample is a punch biopsy insert. 
     
     
         3 . The implant of  claim 1 , wherein the tissue sample comprises cartilage. 
     
     
         4 . The implant of  claim 1 , wherein the at least one first open pore further comprises a plurality of first open pores disposed along the first region of the tissue scaffold component that is configured to define at least the portion of the outer ear framework of the patient's auricle after implantation of the implant into the patient. 
     
     
         5 . The implant of  claim 1 , wherein the plurality of open pores further comprises at least one third open pore having a third average diameter that is distinct from the first diameter and greater than the second average diameter. 
     
     
         6 . The implant of  claim 1 , wherein the biocompatible polymeric material is selected from the group consisting of: polycaprolactone (PCL), polyvinyl alcohol (PVA), polysebacic acid, polyethylene glycol (PEG), polylactic acid (PLA), polyethylene (PE), polyurethane (PU), extracellular tissue matrix, polysiloxane, polyetheretherketone (PEEK), polyetherketoneketone (PEKK), and combinations thereof. 
     
     
         7 . The implant of  claim 1 , wherein the tissue scaffold component further comprises a bioactive agent selected from the group consisting of: a cell adhesion factor, a growth factor, a peptide, a cytokine, a hormone, a pharmaceutical active, and combinations thereof. 
     
     
         8 . The implant of  claim 1 , wherein the tissue scaffold component further comprises a biomaterial selected from the group consisting of: an isolated tissue material, a hydrogel, acellularized dermis, an acellularized tissue matrix, a composite of acellularized dermis matrix and designed polymer, or a composite of acellularized tissue matrix and polymer, and combinations thereof. 
     
     
         9 . The implant of  claim 1 , wherein the tissue scaffold component further comprises a drain port and an internal channel in fluid communication therewith. 
     
     
         10 . The implant of  claim 1 , wherein the first diameter of the at least one first open pore is greater than or equal to about 1 mm to less than or equal to about 12 mm and the first diameter is at least 100% greater than the second average diameter. 
     
     
         11 . The implant of  claim 1 , wherein the at least one first open pore that defines the hollow feature further comprises a back stop rim or ledge configured to prevent displacement of the tissue sample during implantation of the implant into the patient. 
     
     
         12 . The implant of  claim 12 , wherein the hollow feature accepts a portion of the tissue sample and is configured to allow the tissue sample to protrude from the tissue scaffold component by greater than or equal to about 50 micrometers to less than or equal to about 10 mm. 
     
     
         13 . An implant assembly for reconstruction of auricular tissue in a patient, the implant assembly comprising:
 a first tissue scaffold component comprising a first biocompatible polymeric material having a plurality of open pores, wherein the plurality of open pores includes at least one first open pore having a first diameter and a plurality of second open pores having a second average diameter distinct from the first diameter, wherein the at least first one open pore defines a hollow feature configured to receive a tissue sample insert and the plurality of second open pores is distributed throughout a body of the first tissue scaffold component and is configured to support cell growth, wherein the first tissue scaffold component defines a central void region and is configured to define at least a portion of an outer ear framework of the patient after implantation; and   a second tissue scaffold component comprising a second biocompatible polymeric material having a plurality of third open pores configured to support cell growth, wherein the second tissue scaffold component defines a base portion and after implantation of the implant assembly into the patient, the second tissue scaffold component seats within the central void region of the first tissue scaffold component, so that the second tissue scaffold component is secured to the first tissue scaffold component, wherein the first biocompatible polymeric material and the second biocompatible material may be the same or distinct from one another.   
     
     
         14 . The implant assembly of  claim 13 , wherein the first tissue scaffold component further comprises a first interlock member and the second tissue scaffold component further comprises a second interlock member, wherein after implantation into the patient, the first interlock member and the second interlock member are coupled together to secure the first tissue scaffold component to the second tissue scaffold component. 
     
     
         15 . The implant assembly of  claim 14 , wherein the first interlock member and the second interlock member together define a dove tail interlock assembly or an offset snap assembly. 
     
     
         16 . The implant assembly of  claim 13 , wherein the second tissue scaffold component comprises a projection and the first tissue scaffold component defines a void to receive the projection, wherein the projection is configured to elevate the implant assembly. 
     
     
         17 . The implant assembly of  claim 13 , wherein the second tissue scaffold component comprises a rectangular projection and the first tissue scaffold component defines a rectangular void to receive the rectangular projection, wherein the rectangular projection is configured to elevate the implant assembly. 
     
     
         18 . The implant assembly of  claim 13 , wherein the at least one first open pore that defines the hollow feature further comprises a back stop rim or ledge configured to prevent displacement of the tissue sample during implantation of the implant into the patient. 
     
     
         19 . The implant assembly of  claim 18 , wherein the hollow feature accepts a portion of the tissue sample and is configured to allow the tissue sample to protrude from the first tissue scaffold component by greater than or equal to about 50 micrometers to less than or equal to about 10 mm. 
     
     
         20 . The implant assembly of  claim 13 , wherein the first biocompatible polymeric material and the second biocompatible polymeric material are independently selected from the group consisting of: polycaprolactone (PCL), polyvinyl alcohol (PVA), polysebacic acid, polyethylene glycol (PEG), polylactic acid (PLA), polyethylene (PE), polyurethane (PU), extracellular tissue matrix, polysiloxane, polyetheretherketone (PEEK), polyetherketoneketone (PEKK), and combinations thereof.