Dermal micro-organs, methods and apparatuses for producing and using the same

Abstract

Embodiments of the present invention provide Dermal Micro-organs (DMOs), methods and apparatuses for harvesting the same. Some embodiments of the invention provide a DMO including a plurality of dermal components, which substantially retain the micro-architecture and three dimensional structure of the dermal tissue from which they are derived. An apparatus for harvesting the DMO may include, according to some exemplary embodiments, a support configuration to support a skin-related tissue structure from which the DMO is to be harvested, and a cutting tool able to separate the DMO from the skin-related tissue structure. Exemplary embodiments of the invention provide a genetically modified dermal micro-organ expressing at least one recombinant gene product. Some embodiments of the invention provide methods and apparatuses for implanting a genetically modified DMO.

What is claimed is: 
     
         1 . An apparatus for implanting a dermal micro-organ, the apparatus comprising:
 a. a loading syringe comprising a first tubular element;   b. an implanting tool comprising a second tubular element;   c. a support structure to hold a skin-related tissue structure in place, wherein said dermal micro-organ is to be implanted within said skin related tissue structure;   d. an introducer for puncturing said skin related tissue structure;   e. a stopper tool able to be connected to said support structure, said stopper tool comprising a rod able to be inserted within the lumen of the implanting tool, said stopper assisting in maintaining the position of a dermal micro-organ during implantation;   wherein said support structure comprises a third tubular element comprising a site of insertion in the support structure, wherein said second tubular element may be inserted through said third tubular element and said third tubular element provides an implanting axis, and wherein said dermal micro-organ consists essentially of a plurality of dermal components and lacking a complete epidermal layer.   
     
     
         2 . The apparatus of  claim 1 , wherein said support structure further comprises:
 a. a vacuum chamber comprising an inner support surface able to hold said skin-related tissue structure in a desired shape and position to enable said implanting tool to implant said dermal micro-organ into said skin-related tissue structure, wherein said third tubular element is connected to said vacuum chamber; and   b. one or more vacuum channels to fluidically connect said vacuum chamber with at least one vacuum source.   
     
     
         3 . The apparatus of  claim 2 , wherein said vacuum chamber further comprises
 a. at least an elevated protrusion, said elevated protrusion able to support a plateau of epidermal and dermal skin layers from said skin-related tissue structure above the trajectory of said implanting tool; and   b. a central channel co-axial with said third tubular element and distal to said elevated protrusion relative to said site of insertion, said central channel able to support skin-related tissue.   
     
     
         4 . The apparatus of  claim 1 , wherein said introducer comprising
 a. a fourth tubular element, and   b. a fifth tubular element,   wherein said fourth tubular element inserts through said fifth tubular element and extends beyond the distal end of said fifth tubular element; said fourth and fifth tubular elements together insert at said site of insertion coaxially within said third tubular element; and said fifth tubular element remains coaxial and within said third tubular element upon withdrawal of said fourth tubular element.   
     
     
         5 . The apparatus of  claim 4 , wherein said fourth tubular element is an inner needle and said fifth tubular element is an outer sleeve. 
     
     
         6 . The apparatus of  claim 1 , wherein said second tubular element comprises an implanting needle able to advance along an implanting axis and to implant a dermal micro-organ along said implanting axis. 
     
     
         7 . The apparatus of  claim 6 , wherein said implanting needle tip is beveled. 
     
     
         8 . The apparatus of  claim 1 , wherein said dermal micro-organ is a genetically modified dermal micro-organ. 
     
     
         9 . A method of implanting a dermal micro-organ into a subject comprising the steps of:
 a. loading said dermal micro-organ into a loading syringe, said loading syringe comprising a first tubular element;   b. transferring said dermal micro-organ from said loading syringe into an implanting tool, said implanting tool comprising a second tubular element;   c. placing a support structure at an implantation site, wherein said support structure is in contact with an epidermal layer of said subject and said implanting axis is generally perpendicular with said epidermal layer of skin of said subject, wherein said support configuration comprises a third tubular element and a vacuum chamber, and wherein said third tubular element is substantially parallel with said epidermal surface of said subject, said third tubular element and said vacuum chamber being connected, so that said implanting tool comprising said second tubular element is able to be inserted within and substantially coaxial with said third tubular element;   d. supporting a skin-related tissue structure at said implantation site wherein said dermal micro-organ is to be implanted;   e. puncturing said skin-related tissue structure; and   f. advancing said implanting tool into said skin-related tissue structure along said implanting axis;   g. withdrawing said second tubular element wherein said dermal micro-organ remains within said skin-related tissue structure;   wherein said dermal micro-organ consists essentially of a plurality of dermal components and lacking a complete epidermal layer.   
     
     
         10 . The method of  claim 9 , wherein said dermal micro-organ is a genetically modified dermal micro-organ. 
     
     
         11 . The method of  claim 9 , wherein said vacuum chamber comprises at least an elevated protrusion and a central channel, said elevated protrusion proximal and said central channel distal to said site of insertion; and wherein said vacuum condition aligns said implanting axis to be co-axial with said central channel. 
     
     
         12 . The method of  claim 9 ,
 a. wherein said supporting comprises applying a vacuum condition to said vacuum chamber, said vacuum condition causing said skin-related structure to be supported at an inner support surface of said vacuum chamber;   b. wherein said puncturing comprises inserting said fourth and fifth tubular elements through said third tubular element, substantially coaxially, and into said skin-related structure followed by withdrawing said fourth tubular element from said skin-related structure and from said third tubular element, said fifth tubular element remaining within said third tubular element and within said skin-related structure;   c. wherein said implanting comprises inserting said second tubular element through and coaxially with said fifth tubular element, said second tubular element entering said skin-related structure; and   d. said withdrawing comprises withdrawing said second tubular element over said rod, wherein said rod element remains static relative to the support structure and said withdrawing results in said micro-organ being implanted within said subject.   
     
     
         13 . The method of  claim 9 , wherein said puncturing creates only a single puncture point in said skin-related structure. 
     
     
         14 . The method of  claim 9 , wherein said implanting comprising implanting a dermal micro-organ in a linear form. 
     
     
         15 . The method of  claim 9 , wherein said implanting is into dermal tissue. 
     
     
         16 . The method of  claim 9 , wherein said implanting is into or under the skin. 
     
     
         17 . The method of  claim 9 , wherein said implanting is deeper in the body.