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Patent Issued for Methods for Producing ECM-Based Biomaterials

August 5, 2014



By a News Reporter-Staff News Editor at Life Science Weekly -- A patent by the inventors Farrell, Laura-Lee (Maplewood, MN); Johnson, Chad E. (West Lafayette, IN), filed on November 13, 2012, was published online on July 22, 2014, according to news reporting originating from Alexandria, Virginia, by NewsRx correspondents (see also Cook Medical Technologies LLC).

Patent number 8784890 is assigned to Cook Medical Technologies LLC (Bloomington, IN).

The following quote was obtained by the news editors from the background information supplied by the inventors: "Biomaterials have been used in a variety of medical applications, including joint repair and replacement; periodontal reconstruction; repair or replacement of injured, diseased or malformed bones and tissues; wound healing; and the treatment of burns and diabetic ulcers. Extracellular matrix (ECM) materials, including those derived from submucosa and other tissues, are known tissue graft materials used in these medical applications. See, e.g., U.S. Pat. Nos. 4,902,508, 4,956,178, 5,281,422, 5,372,821, 5,554,389, 6,099,567, and 6,206,931. These materials typically are derived from a variety of biological sources including, for example, small intestine, stomach, urinary bladder, skin, pericardium, dura mater, fascia, and the like.

"Submucosa and other ECM-based materials have been shown to include a variety of components other than collagen that can contribute to the bioactivity of the materials and to their value in medical grafting and other uses. As examples, ECM materials can include growth factors, cell adhesion proteins, proteoglycans, nucleic acids, and lipids. Depending on the needs for their use, ECM materials may be subjected to various manipulations in their manufacture, which can deplete an ECM of these components and alter its physical properties, including integrity and strength. Ideally, an ECM-based medical device should have sufficient integrity and strength to facilitate stable engraftment via suturing to suitable supporting structures that are designed to reduce the risk of inappropriate device migration in a body. Given that manipulation of ECM-based materials may result in a spongy material that is difficult to suture or attach to supporting structures, there is a need for improved ECM-based materials and medical products, as well as methods for preparing and using the same."

In addition to the background information obtained for this patent, NewsRx journalists also obtained the inventors' summary information for this patent: "In one embodiment, a method for forming an extracellular matrix material (ECM) material includes providing an ECM composition containing ECM particles differing in their ability to migrate through a fluid medium, such as an aqueous liquid medium, when subjected to a centrifugal force. The ECM particles can differ in their size, density, shape, or combinations thereof, relative to one another, and can include a population of volumetrically expanded ECM particles. The ECM particles in the composition are combined in a fluid medium to form a flowable ECM composition. The flowable ECM composition is introduced to a mold and subjected to a centrifugal force about an axis of rotation for a period of time sufficient to distribute the ECM particles in the mold according to size, density, shape, or combinations thereof. The contents in the mold are processed to form a dried ECM material having a shape defined by the mold. The resulting dried ECM material can be characterized by a density gradient extending from a less dense region to a more dense region.

"In certain embodiments, the resulting dried ECM material can be characterized by a central longitudinal axis at the axis of rotation and by outer surfaces, such that the ECM particles establish a density gradient in the ECM material. In one form, the dried ECM material can be characterized by an outer density near an outer surface that is greater than an inner density of the dried ECM material toward the central longitudinal axis. In another form, the dried ECM material can be characterized by an outer density near an outer surface that is less than an inner density of the dried ECM material toward the central longitudinal axis. Conditions in the preparation such as the size, density, and/or shape of the ECM particles, and/or the specific gravity of a liquid medium used to prepare the suspension of ECM particles, can be varied to achieve the various forms of the final, dried ECM material. Further, differentially-migrating populations of ECM particles included in the flowable ECM composition can include differing levels of bioactive agents (e.g. FGF-2) retained from source tissues, thus creating ECM constructs having both density and bioactivity gradients.

"In one embodiment, the ECM composition is prepared from expanded or and/or non-expanded ECM source materials processed to form a particulate composition comprising ECM particles differing in their ability to migrate through a fluid medium when subjected to centrifugal force. The ECM particles can differ in size, density, shape, or any or all of these, relative to one another. A particulate composition may be prepared by comminuting an expanded or non-expanded ECM source material. In another embodiment, the ECM composition is prepared by admixing a first population of ECM particles with a second, separately-prepared population of ECM particles, the first population characterized by a first average particle size or first average particle density or first general particle shape, and the second population characterized by a second average particle size or second average particle density or second general particle shape, whereby the corresponding average particle sizes or average particle densities or general particle shapes differ from one another in the first and second populations. One or both of the first and second populations may contain a population of ECM particles that have been expanded in volume by contact with a denaturing agent such as an acid or base.

"In another embodiment, a porous, substantially acellular ECM material includes first and second populations of ECM particles cast under centrifugal force in a mold and dried to form a porous, substantially acellular ECM material, characterized by a density gradient extending from a less dense central region to a more dense outer region, or vice versa. The first population of ECM particles is characterized by a first average particle size or first average particle density or a first general particle shape. The second population is characterized by a second average particle size or second average particle density or second general particle shape, such that the corresponding average particle sizes or average particle densities or general particle shapes differ from one another in the first and second populations. The porous, substantially acellular ECM material includes a sufficient amount of expanded ECM particles comminuted from expanded ECM source materials sufficiently treated with a denaturing medium, such as an alkaline medium, so that the porous, substantially acellular ECM material is expandable in an aqueous fluid environment by at least 100% in volume."

URL and more information on this patent, see: Farrell, Laura-Lee; Johnson, Chad E.. Methods for Producing ECM-Based Biomaterials. U.S. Patent Number 8784890, filed November 13, 2012, and published online on July 22, 2014. Patent URL: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=8784890.PN.&OS=PN/8784890RS=PN/8784890

Keywords for this news article include: Technology.

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Source: Life Science Weekly


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