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

• US 9,107,896 B2
• Filed: 02/09/2012
• Issued: 08/18/2015
• Est. Priority Date: 11/05/2001
• Status: Expired due to Fees

• Current Assignee: Medgenics Medical Israel Ltd.
• Original Assignee: Medgenics Medical Israel Ltd.
• Inventors: Bellomo, Stephen F., Piva, Guillermo Alberto, Rosenberg, Lior, Bukhman, Mordechay, Stern, Baruch S., Shalhevet, David, Shavitt, Menachem D., Pearlman, Andrew L., Shani, Noam, Almon, Einat, Lippin, Itzhak
• Primary Examiner(s): McEvoy, Thomas
• Assistant Examiner(s): SZPIRA, JULIE ANN
• Application Number:
  US13/369,329
• Publication Number:
  US 20120201793A1
• Time in Patent Office: 1,286 Days
• Field of Search: 606/132, 606/133, 606/184, 606/187
• US Class Current: 1/1
• CPC Class Codes: A61B 10/0275 with sample notch, e.g. on the side of inner stylet
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 17/322 Skin grafting apparatus
• CPC Class Codes: A61B 2017/0023 disposable
• CPC Class Codes: A61B 2017/00969 used for transplantation
• CPC Class Codes: A61B 2017/2808 Clamp, e.g. towel clamp
• CPC Class Codes: A61B 2017/320052 Guides for cutting instruments by marking A61B2090/395
• CPC Class Codes: A61B 2017/320064 with tissue or sample retaining means
• CPC Class Codes: A61B 2017/3225 with processing of harvested tissue
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61F 2/105 Skin implants, e.g. artificial skin
• CPC Class Codes: A61K 35/36 Skin; Hair; Nails; Sebaceous glands; Cerumen; Epidermis; Epithelial cells; Keratinocytes; Langerhans cells; Ectodermal cells islets of Langerhans A61K35/39
• CPC Class Codes: A61K 38/1816 Erythropoietin [EPO]
• CPC Class Codes: A61K 38/193 Colony stimulating factors [CSF]
• CPC Class Codes: A61K 38/2066 IL-10
• CPC Class Codes: A61K 38/215 IFN-beta
• CPC Class Codes: A61K 38/27 Growth hormone [GH], i.e. somatotropin
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: C12N 2502/094 keratinocytes
• CPC Class Codes: C12N 2502/1323 : Adult fibroblasts
• CPC Class Codes: C12N 2510/00 : Genetically modified cells
• CPC Class Codes: C12N 5/0698 : Skin equivalents
• CPC Class Codes: Y10T 83/929 : Tool or tool with support

Abstract

Embodiments of the present invention provide Dermal Micro-organs (DMOs), methods and apparatuses for producing 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, having dimensions selected so as to allow passive diffusion of adequate nutrients and gases to cells of the DMO and diffusion of cellular waste out of the cells. Some embodiments of the invention provide methods and apparatuses for harvesting the DMO. 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.

Claims

1. An apparatus for directly harvesting a dermal micro-organ from a subject comprising:

(a) a support configuration to support a skin-related tissue structure of a subject from which said dermal micro-organ is to be harvested; and

(b) a cutting tool able to directly cut said dermal micro-organ from said skin-related tissue structure;

wherein said support configuration comprises a vacuum chamber comprising an inner support surface able to maintain said skin-related tissue structure in a desired shape and position within said vacuum chamber when a vacuum condition is applied to said vacuum chamber, in order to enable the cutting tool to cut said dermal micro-organ directly from said skin-related tissue structure;

wherein the support configuration comprises a guiding channel through which the cutting tool may be inserted, and which forms a trajectory for the cutting tool that enables the cutting tool to directly harvest said dermal micro-organ; and

wherein said harvested dermal micro-organ is an explant of living tissue consisting essentially of a plurality of dermal components located below the epidermis and lacking a complete epidermal layer.

2. The apparatus of claim 1, further comprising one or more vacuum channels to fluidically connect at least part of said inner support surface with at least one vacuum source.

3. The apparatus of claim 1, further comprising a drill stop configured to allow the cutting tool to advance a predetermined distance within said vacuum chamber.

4. The apparatus of claim 1, wherein said vacuum chamber further comprises an elevated protrusion able to maintain a plateau of skin generally above the trajectory of the cutting tool, such that the harvested dermal micro-organ is directly cut from the surrounding tissue by the advance of the cutting tool into a fat layer.

5. The apparatus of claim 1, further comprising a rotation mechanism able to rotate said cutting tool, wherein said cutting tool comprises a rotatable cutting tool.

6. The apparatus of claim 1, wherein said supported skin-related tissue structure comprises a fat layer located below said plurality of dermal components.

7. The apparatus according to claim 1, wherein the trajectory of the cutting tool is generally parallel to the surface of the skin-related tissue structure.

8. A method of harvesting a dermal micro-organ directly from a subject using the apparatus of claim 1, comprising the steps of:

(1) supporting a skin-related tissue structure from which said dermal micro-organ is directly harvested with said support configuration;

(2) inserting said cutting tool through the guiding channel in the support configuration and advancing said cutting tool along a trajectory that enables the cutting tool to directly cut said dermal micro-organ from said supported skin-related tissue structure; and

(3) recovering said dermal micro-organ,

wherein said harvested dermal micro-organ is an explant of living tissue consisting essentially of a plurality of dermal components located below the epidermis and lacking a complete epidermal layer.

9. The method according to claim 8, wherein said cutting comprises making only a single incision on the outer surface of said skin-related tissue structure.

10. The method according to claim 8, wherein (1) said supporting comprises applying a vacuum condition to said vacuum chamber, wherein said vacuum condition causes said skin-related structure to be held at an inner support surface of said vacuum chamber.

11. The method according to claim 8, wherein said harvesting method further comprises rotating said cutting tool.

12. The apparatus according to claim 4, wherein the elevated protrusion is located at the distal end of the cutting trajectory.

13. The apparatus according to claim 5, wherein the rotatable cutting tool comprises a coring needle.

14. The method according to claim 8, wherein the vacuum chamber of the apparatus further comprises an elevated protrusion able to maintain a plateau of skin generally above the trajectory of the cutting tool, such that the harvested dermal micro-organ is directly cut from the surrounding tissue by the advance of the cutting tool into a fat layer.

15. The method according to claim 14, wherein the elevated protrusion is located at the distal end of the cutting trajectory.

16. The method according to claim 8, wherein the method comprises making two lance cuts on the outer surface of the skin-related tissue structure either before or after contacting the skin-related tissue structure with the apparatus, wherein the lance cuts mark entry and exit points for the cutting tool.

17. The method according to claim 11, wherein the cutting tool comprises a coring needle.

18. The method according to claim 8, wherein the apparatus comprises a drill stop configured to allow the cutting tool to advance a predetermined distance within the vacuum chamber.

19. The method according to claim 8, wherein the harvested dermal micro-organ substantially retains the micro-architecture and three-dimensional structure of the dermal tissue from which it was derived.

20. The method according to claim 8, wherein the cutting trajectory along which the cutting tool is advanced is generally parallel to the surface of the skin-related tissue structure.