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Researchers Submit Patent Application, "Combination Products Including Bioactive Glass and Collagen and Kits Including the Same", for Approval

September 11, 2014



By a News Reporter-Staff News Editor at Politics & Government Week -- From Washington, D.C., VerticalNews journalists report that a patent application by the inventors Pomrink, Gregory J. (Newberry, FL); Tosun, Zehra (Gainesville, FL); Cao, Cecilia A. (Gainesville, FL); Clark, Joshua (Alachua, FL), filed on March 27, 2014, was made available online on August 28, 2014.

The patent's assignee is NovaBone Products, LLC.

News editors obtained the following quote from the background information supplied by the inventors: "Collagen is the main component of connective tissue and is generally found in the body as a triple helix. Collagen is also prevalent in bone. Known methods of crosslinking include introducing disulfide bonds between individual collagen molecules and fibrils. Crosslinked collagen can have enhanced mechanical attributes. The addition of crosslinked collagen to wounded tissue or bone defects may serve to provide structural support. There are various ways to crosslink collagen, such as by UV light and the use of chemical crosslinkers. Herein is provided a novel way to crosslink collagen in a manner that maintains the structure of collagen without introducing toxins that are difficult to remove.

"Bioactive glass was originally developed in 1969 by L. Hench. Additionally bioactive glasses were developed as bone replacement materials, with studies showing that bioactive glass can induce or aid in osteogenesis. Hench et al, J. Biomed. Mater. Res. 5:117-141 (1971). Bioactive glass can form strong and stable bonds with bone. Piotrowski et al., J. Biomed. Mater. Res. 9:47-61(1975). Further, bioactive glass is not considered toxic to bone or soft tissue from studies of in vitro and in vivo models. Wilson et al., J. Biomed. Mater. Res. 805-817 (1981). Exemplary bioactive glasses known in the art include 45S5, 45S5B1, 58S, and S70C30. The original bioactive glass, 45S5, is melt-derived. Sol-gel derived glasses have nanopores that allow for increased surface area and bioactivity.

"U.S. Patent Application Publication No. 2002/0055143 discloses cement particles UV crosslinked with collagen.

"U.S. Pat. No. 8,252,055 discloses crosslinking a collagen mineral containing composition including Bioglass."

As a supplement to the background information on this patent application, VerticalNews correspondents also obtained the inventors' summary information for this patent application: "One aspect of the invention provides for a method for crosslinking collagen. An ion-containing solution is mixed with collagen and a glass to form a paste. The paste is freeze-dried to form a composite.

"Another aspect of the invention provides for a method for crosslinking collagen fibers. Water or an ion-containing solution is mixed with collagen and a glass to form a paste. The paste is freeze-dried to form a composite. The composite is immersed in water or solutions containing divalent or polyvalent metal ions. The composite is freeze-dried.

"Yet another aspect of the invention provides for a method for crosslinking collagen. An ion-containing solution is mixed with collagen and a glass to form a paste. The paste is transferred to a mold. The paste is freeze-dried to form a composite.

"Another aspect of the invention provides for a method for crosslinking collagen fibers. Water or an ion-containing solution is mixed with collagen and a glass to form a paste. The paste is freeze-dried to form a composite. The composite is immersed in water or solutions containing divalent or polyvalent metal ions. The composite is freeze-dried and then dried.

"An aspect provides for a mixture of collagen and a glass. The mixture comprises from 60 wt. % to 90 wt. % of the glass. The collagen is crosslinked by the glass. The mixture does not comprise chitosan or an organic crosslinking agent.

"The invention also provides for a crosslinked collagen material consisting of collagen and a glass. Yet another aspect of the invention provides for a crosslinked collagen material consisting of collagen, water, and a glass. Alternatively, the invention provides for a crosslinked collagen material consisting of collagen, an ion-containing solution, and a glass.

"The invention also provides for a crosslinked collagen material consisting of collagen fibers and a glass. Alternatively, the invention provides for a crosslinked collagen material consisting of collagen fibers, water, and a glass. Another aspect of the invention provides for a crosslinked collagen material consisting of collagen fibers, an ion-containing solution, and a glass.

"The invention provides for a combination product that includes a porous and nonporous bioactive glass and collagen. In the combination product the bioactive glass may be present in a weight ratio of from 80% to 97% in proportion to the total weight of the bioactive glass and the collagen. The combination product may include from 85 wt. % to 97.5 wt. % of the bioactive glass. The combination product may be in a form of a packable graft. The packable graft may include 75-95 wt. % bioactive glass and 5-25 wt. % collagen. The packable graft may include 85 wt. % bioactive glass and 15 wt. % collagen. In the combination product, the bioactive glass may include 55-65% 1000-2000 um bioactive glass, 10-20% 90-710 um bioactive glass, and 10-20% 32-125 um bioactive glass. In the combination product the bioactive glass may include 60% 1000-2000 um bioactive glass, 12.5% 90-710 um bioactive glass, and 12.5% 32-125 um bioactive glass. In the combination product, the 1000-2000 um bioactive glass is porous. The combination product may be in a form of a collagen bioactive glass composite. The composite may include 75-95 wt. % bioactive glass and 5-25 wt. % collagen. The composite may include 90 wt. % bioactive glass and 10 wt. % collagen. The bioactive glass of the composite may include 55-65% 1000-2000 um bioactive glass, 10-20% 90-710 um bioactive glass, and 10-20% 32-125 um bioactive glass. The bioactive glass of the composite may include 60% 1000-2000 um bioactive glass, 15% 90-710 um bioactive glass, and 15% 32-125 um bioactive glass. The 1000-2000 um bioactive glass of the composite is porous. The combination product may be in a form of a strip. The strip may include 85-97 wt. % bioactive glass and 3-15 wt. % collagen. The strip may include 95 wt. % bioactive glass and 5 wt. % collagen. The strip may include 97.5 wt. % bioactive glass and 2.5 wt. % collagen. The bioactive glass of the strip may include 53.5-73.5% 1000-2000 um bioactive glass, 10-20% 90-710 um bioactive glass, 10-20% 32-125 um bioactive glass. The bioactive glass of the strip may include 63.33% 1000-2000 um bioactive glass, 15.83% 90-710 um bioactive glass, 15.83% 32-125 um bioactive glass. The 1000-2000 um bioactive glass of the strip is porous. In the combination product, the bioactive glass may include 64.68% 1000-2000 micrometer bioactive glass, 16.16% 90-710 micrometer bioactive glass, 16.16% 32-125 micrometer bioactive glass. The combination product may further include at least one therapeutic agent, protein, or glycosaminoglycan.

"Another aspect provides for a kit comprising a combination product in a form of a packable graft, composite or a strip and a packaging. The packaging may be a double peel packaging. The packaging may include an inner tray, wherein the combination product is contained within the inner tray, an inner tray lid, an outer tray, wherein the inner tray is placed in the outer tray, and an outer tray lid. The kit may further include a dispenser box. The kit may further include a syringe. The combination product may be disposed within the syringe. The syringe may include a removable cap. The syringe may be placed in the inner tray. The kit may include a syringe comprising a removable cap, wherein the syringe is sealed in a pouch.

"Furthermore, the invention provides for a method for ionically crosslinking collagen. The method includes mixing an ion-containing solution with the 10 wt. % collagen and 90 wt. % bioactive glass to form a paste and freeze-drying the paste to form a composite.

BRIEF DESCRIPTIONS OF THE FIGURES

"FIG. 1 is a photomicrograph of crosslinked collagen bioactive glass strip composite at 29.9.times. magnification.

"FIG. 2 is a photomicrograph of crosslinked collagen bioactive glass strip composite at 300.times. magnification.

"FIG. 3 depicts a graph of blood absorption of Bioactive Strip, Composite and Packable products.

"FIGS. 4 A-B are photographs depicting a CBG composite product and its packaging.

"FIG. 4C is a photograph of the CBG composite product combined with a fluid.

"FIG. 4 D depicts a photograph of an exemplary dispenser box.

"FIG. 5 depicts a bar graph showing the average porosity of MacroFORM Composite, and Bioactive Strip Lots.

"FIG. 6A is a photograph of the dry form of the exemplary CBG strip placed in its packaging.

"FIG. 6B is a photograph of the exemplary CBG strip in its packaging during hydration with blood.

"FIG. 6C is a photograph of the exemplary CBG strip in a hydrated state.

"FIG. 6D is a photograph of the exemplary CBG strip in a hydrated state.

"FIGS. 7A-C are photographs of the dry form of the exemplary CBG strip placed in its packaging.

"FIG. 8 is a photograph of the exemplary inner and outer trays of the packaging for the CBG strips."

For additional information on this patent application, see: Pomrink, Gregory J.; Tosun, Zehra; Cao, Cecilia A.; Clark, Joshua. Combination Products Including Bioactive Glass and Collagen and Kits Including the Same. Filed March 27, 2014 and posted August 28, 2014. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=6404&p=129&f=G&l=50&d=PG01&S1=20140821.PD.&OS=PD/20140821&RS=PD/20140821

Keywords for this news article include: NovaBone Products, NovaBone Products LLC.

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Source: Politics & Government Week


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