US2021079352A1PendingUtilityA1

Biomimetic lamellar tissue scaffolds

Assignee: ULTRA SMALL FIBERS LLCPriority: Dec 5, 2018Filed: Nov 29, 2020Published: Mar 18, 2021
Est. expiryDec 5, 2038(~12.4 yrs left)· nominal 20-yr term from priority
A61F 2/30756B82Y 5/00A61L 15/32A61F 2002/30766A61F 2002/0086A61L 27/56C12N 5/0667A61K 38/39A61L 2300/412A61F 2/08A61L 27/225A61L 15/58A61L 2400/12A61L 15/44A61F 2/02A61L 2430/06A61L 27/54A61F 2/0077A61L 15/225A61F 2250/0031
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Claims

Abstract

A biomimetic lamellar tissue scaffold for tissue regeneration comprises a plurality of lamellae formed of a polymer film and each having a first surface and a second surface. A patterned array of polymer nanofibers protrudes from the first surface of each lamella of the plurality. The lamellae form a plurality of interlamellar spaces between the first and second surfaces of adjacent lamellae. Protuberances formed on the first surface of each lamella maintain the interlamellar spaces. The arrays of polymer nanofibers on the first lamellar surface of each lamella protrude into the interlamellar spaces between adjacent lamellae and are configured to influence the propagation and differentiation of cells populated to or recruited to the scaffold.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A scaffold for tissue regeneration comprising:
 a plurality of lamellae formed of a polymer film and each having a first surface with a patterned array of polymer nanofibers protruding from said first surface, and a second surface;   a plurality of interlamellar spaces formed between said first surfaces of said lamellae and said second surfaces of adjacent said lamellae; and   a plurality of protuberances formed on said lamellae to maintain said interlamellar spaces;   wherein said array of polymer nanofibers on said first lamellar surfaces protrude into said interlamellar spaces; and   wherein said patterned array is configured to influence the propagation and differentiation of cells populated to or recruited to said scaffold.   
     
     
         2 . The scaffold of  claim 1  wherein said lamellae further comprise perforations between said first surface and said second surface. 
     
     
         3 . The scaffold of  claim 1  wherein said polymer film is bioabsorbable. 
     
     
         4 . The scaffold of  claim 1  wherein said polymer film is treated with another polymer such as poly-L-lysine or poly-D-lysine, or a biological substance such as proteoglycans (proteoglycan 4) or glycoproteins to improve surface wetting and cell attachment. 
     
     
         5 . The scaffold of  claim 1  wherein said lamellae are oriented perpendicular to the plane of said scaffold 
     
     
         6 . The scaffold of  claim 1  wherein said lamellae are oriented parallel to the plane of said scaffold. 
     
     
         7 . The scaffold of  claim 1  wherein said lamellae are arranged as parallel layers. 
     
     
         8 . The scaffold of  claim 1  wherein said lamellae form a coil. 
     
     
         9 . The scaffold of  claim 1  wherein said patterned array of nanofibers comprises rows of nanofibers. 
     
     
         10 . The scaffold of  claim 1  wherein said patterned array is uniform over said first surface of said lamella. 
     
     
         11 . The scaffold of  claim 1  wherein said first surface of said lamella has a first region with a first said patterned array, and a second region with a second said patterned array. 
     
     
         12 . A method for treating a patient using a biomimetic scaffold comprising the steps of:
 providing a scaffold formed of one or more lamellae with a nanofiber array formed on a first surface of said one or more lamellae, said scaffold further comprising one or more interlamellar spaces wherein said nanofiber array protrudes into said interlamellar spaces;   preparing a treatment site on said patient to receive said scaffold; and   implanting said scaffold at said site.   
     
     
         13 . The method of  claim 12  further comprising the step of affixing said scaffold at said site. 
     
     
         14 . The method of  claim 12  wherein the fixation method comprises using a fibrin glue. 
     
     
         15 . The method of  claim 12  wherein the fixation method comprises using suture or mechanical fixation. 
     
     
         16 . The method of  claim 12  wherein said treatment site comprises an articular lesion. 
     
     
         17 . The method of  claim 16  wherein preparing said treatment site comprises performing a microfracture procedure. 
     
     
         18 . The method of  claim 12  wherein preparing said treatment site comprises the application of a bioactive material to the site prior to implanting the scaffold. 
     
     
         19 . The method of  claim 12  wherein said scaffold is immersed in a biologic fluid containing stem cells prior to implanting. 
     
     
         20 . A method for creating a tissue structure for implantation in a patient comprising the steps of:
 providing a scaffold formed of one or more lamellae with a nanofiber array formed on a first surface of said one or more lamellae, said scaffold further comprising one or more interlamellar spaces wherein said nanofiber array protrudes into said interlamellar spaces, and said scaffold is configured to mimic a native tissue structure;   submerging said scaffold in a biologic solution comprising stem cells;   maintaining said scaffold and biologic solution in a suitable bioreactor until said scaffold is replaced by extracellular matrix and said tissue structure is complete; and   removing said tissue structure from said bioreactor;   wherein said nanofiber array is configured for optimal stem cell propagation and differentiation into a predetermined cell type.

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