Method for use of a double-structured tissue implant for treatment of tissue defects
Inventors
Shortkroff, Sonya • Tarrant, Laurence J. B. • Roos, Eric J. • Smith, Robert Lane • CLAESSON, HANS P. I.
Assignees
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Publication Number
US-9993326-B2
Publication Date
2018-06-12
Expiration Date
Abstract
A method for use of a double-structured tissue implant or a secondary scaffold stand alone implant for treatment of tissue defects. The double-structured tissue implant comprising a primary scaffold and a secondary scaffold consisting of a soluble collagen solution in combination with a non-ionic surfactant generated and positioned within the primary scaffold. A method of use of a stand alone secondary scaffold implant or unit for treatment of tissue defects.
Core Innovation
The invention relates to an implant for repairing a cartilage or a tissue defect that includes a three-dimensional primary scaffold comprising collagen and defining a plurality of pores, with a top surface and a bottom surface of the implant. A secondary scaffold is provided that comprises lyophilized and dehydrothermally treated collagen and a surfactant, and the secondary scaffold forms a fibrous and cross-linked collagen network within the plurality of pores.
The primary and secondary scaffolds together create a double-structured tissue implant in which the pores of the primary scaffold host the secondary fibrous, cross-linked collagen network. In certain embodiments, the pores are substantially uniform in size with a diameter of about 300±100 μm, and the sizes and diameters of the pores on both the top surface and the bottom surface are substantially the same.
The disclosure further supports configurations in which the implant additionally includes a cell modulator incorporated within the implant, where in some embodiments the cell modulator comprises a bone morphogenetic protein (BMP). The overall approach is supported by processing concepts in which the secondary scaffold is lyophilized and dehydrothermally treated, together with a surfactant, to form the fibrous and cross-linked collagen network inside the pores for tissue defect repair.
Claims Coverage
The provided independent claims define an implant for repairing a cartilage or a tissue defect with a collagen-based double-structured scaffold. Across the two independent claims, the coverage includes four core inventive elements: a collagen primary scaffold with pores and defined top/bottom surfaces, a secondary scaffold defined by lyophilized and dehydrothermally treated collagen plus a surfactant to form a fibrous cross-linked network in the pores, a type I collagen primary scaffold with substantially uniform pores of about 300±100 μm and substantially the same pore sizes on top and bottom, and incorporation of a cell modulator.
A collagen primary scaffold with pores and defined top/bottom surfaces
A three-dimensional primary scaffold comprising collagen and defining a plurality of pores, wherein the primary scaffold defines a top surface and a bottom surface of the implant.
A lyophilized and dehydrothermally treated collagen secondary scaffold with a surfactant that forms a fibrous and cross-linked collagen network in the pores
A secondary scaffold comprising lyophilized and dehydrothermally treated collagen and a surfactant, wherein the secondary scaffold forms a fibrous and cross-linked collagen network within the plurality of pores.
A type I collagen primary scaffold with substantially uniform pores of about 300±100 μm and substantially the same pore sizes on top and bottom
A three-dimensional primary scaffold comprising type I collagen and defining a plurality of pores, wherein the primary scaffold defines a top surface and a bottom surface of the implant; and wherein the pores are substantially uniform in size with a diameter of about 300±100 μm, and wherein the sizes and diameters of the pores on both the top surface and the bottom surface are substantially the same.
A cell modulator incorporated within the implant
A cell modulator incorporated within the implant.
Together, the independent claims cover a double-structured collagen implant in which a primary collagen scaffold with pores and defined top/bottom surfaces contains a secondary scaffold formed from lyophilized and dehydrothermally treated collagen with a surfactant to create a fibrous, cross-linked collagen network within the pores, with one independent claim further including a cell modulator and one reciting type I collagen with substantially uniform pores.
Stated Advantages
Improved chondrocyte viability (reported 96–100%)
Increased matrix production (S-GAG/DNA) and rapid rehydration (<2 s)
High collagen retention (>99%) and high resistance to shrinkage/swelling and dissolution
Stability and rapid wettability
Documented Applications
Repairing a cartilage or a tissue defect using the described implant.
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