Double-structured tissue implant and a method for preparation and use thereof
Inventors
Claesson, Hans Peter Ingemar • Tarrant, Laurence J. B. • Smith, Robert Lane • Shortkroff, Sonya
Assignees
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Publication Number
US-9687590-B2
Publication Date
2017-06-27
Expiration Date
Abstract
A double-structured tissue implant and a method for preparation and use thereof for implantation into tissue defects. The double-structured tissue implant comprising a primary scaffold comprised of collagen and a secondary scaffold comprising a soluble collagen solution in combination with a surfactant generated and positioned within the primary scaffold. A process for preparation of the double-structured implant or the stand alone secondary scaffold comprising lyophilization and dehydrothermal treatment.
Core Innovation
A double-structured tissue implant product is formed with a primary collagen scaffold comprising a first collagen and a plurality of pores. A composition is prepared comprising a second collagen and a surfactant, and the composition is introduced into the plurality of pores of the primary scaffold. The composition is stabilized within the plurality of pores through precipitation, dehydration, and lyophilization to produce the double-structured tissue implant.
The implant uses a collagen-based double structure in which the second collagen is formed within the pores of the primary scaffold, while the primary scaffold provides the porous architecture. In described embodiments, the second collagen system is combined with a surfactant and stabilized within the pores by the precipitation, dehydration, and lyophilization sequence to yield a double-structured implant.
Additional embodiments describe collagen-based implant components and processing constraints, including that the primary scaffold may include Type I collagen, and the second collagen may include Type I or Type II collagen with a non-ionic surfactant. The stabilization may be followed by a dehydrothermal treatment, and loading options include introduction of cells and/or pharmaceutical agents and growth modulators associated with the tissue implant for cartilage lesion repair.
Claims Coverage
The independent claim defines the overall product and making process. Main inventive features are centered on producing a double-structured tissue implant by pore-loading a second-collagen/surfactant composition into a primary collagen scaffold and stabilizing it within the pores using precipitation, dehydration, and lyophilization; dependent claims further refine scaffold and composition details, and add specific dehydrothermal treatment constraints.
Pore-loaded double collagen composition in a primary scaffold
A primary scaffold comprising a first collagen and a plurality of pores; preparing a composition comprising a second collagen and a surfactant; introducing the composition into the plurality of pores of the primary scaffold.
Pore stabilization by precipitation, dehydration, and lyophilization
Stabilizing the composition within the plurality of pores of the primary scaffold through precipitation, dehydration, and lyophilization to produce a double-structured tissue implant.
Type I collagen for the primary scaffold
The primary scaffold includes Type I collagen.
Second collagen comprising Type I or Type II collagen
The second collagen comprises Type I or Type II collagen.
Non-ionic surfactant
The surfactant is a non-ionic surfactant.
Composition comprising at least one pharmaceutical agent
The composition comprises at least one pharmaceutical agent.
Dehydrothermal treatment under vacuum with a temperature/time range
The dehydrothermal treatment comprises temperatures in a range from about 70 degrees C to about 200 degrees C under vacuum for about 30 minutes to about 7 days.
Across the claim set, the core inventive concept is forming a double-structured tissue implant by introducing a second-collagen/surfactant composition into pores of a first-collagen primary scaffold and stabilizing it via precipitation, dehydration, and lyophilization. Dependent claims narrow the collagen types, restrict the surfactant to a non-ionic surfactant, optionally include at least one pharmaceutical agent, and optionally apply a vacuum dehydrothermal treatment within a specified temperature/time range.
Stated Advantages
Rapid wettability/rehydration.
High collagen retention, including collagen retention greater than about 99%.
Minimal size change, including 2–5% within the first hour.
High cell viability, including about 96–100%.
Matrix production (S-GAG/DNA) supporting chondrocyte growth.
Documented Applications
Implantation into cartilage lesion repair, including use with optional microfracture and adhesive sealing.
Use of the implant for chondrocyte growth supported by matrix production (S-GAG/DNA).
A stand-alone secondary scaffold embodiment is described.
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