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    Osteoinductive protein mixtures and purification processes
    1.
    发明授权
    Osteoinductive protein mixtures and purification processes 失效
    骨诱导蛋白混合物和纯化方法

    公开(公告)号：US5371191A

    公开(公告)日：1994-12-06

    申请号：US142686

    申请日：1993-10-26

    申请人： James W. Poser ,  James J. Benedict

    发明人： James W. Poser ,  James J. Benedict

    IPC分类号： A61K38/00 ,  A61F2/00 ,  A61F2/02 ,  A61F2/28 ,  A61F2/32 ,  A61F2/38 ,  A61F2/44 ,  A61K38/18 ,  A61L27/02 ,  A61L27/22 ,  A61P43/00 ,  C07K14/51 ,  C07K3/02 ,  C07K3/20 ,  C07K3/26 ,  C07K15/06

    CPC分类号： C07K14/51 ,  A61F2/28 ,  A61K38/1875 ,  A61L27/025 ,  A61L27/227 ,  A61F2/32 ,  A61F2/38 ,  A61F2/4455 ,  A61F2002/30011 ,  A61F2002/30062 ,  A61F2210/0004 ,  A61F2250/0023 ,  Y10S530/84

    摘要： A method for purifying bone-derived osteoinductive factors including an ultrafiltration process, an anion exchange process, a cation exchange process, and a reverse phase HPLC process. The ultrafiltration process preferably includes a first ultrafiltration step using a membrane having a nominal molecular weight cutoff of approximately 100 kilodaltons (kD) and a second ultrafiltration step employing a membrane having a nominal molecular weight cutoff of approximately 10 kD. For the anion exchange process, a strongly cationic resin is used, preferably having quaternary amine functional groups. Typically, the eluant for the anion exchange process has a conductivity from about 10,260 micromhos (.mu.mhos) (1.026.times.10.sup.-2 siemens (S)) to about 11,200 .mu.mhos (1.120.times.10.sup.31 2 S). For the cation exchange process, a strongly anionic resin is used, preferably having sulfonic acid functional groups. The eluant for the cation exchange process typically has a conductivity from about 39,100 .mu.mhos (3.91.times.10.sup.-2 S) to about 82,700 .mu.mhos (8.27.times.10.sup.-2 S) or more. The HPLC process typically utilizes a column containing hydrocarbon-modified silica packing material. The osteoinductive proteins can be eluted from the HPLC column with an acetonitrile solution in combination with aqueous trifluoracetic acid. The purification processes yield osteoinductively active protein mixtures.

    摘要翻译： 用于纯化骨衍生的骨诱导因子的方法，包括超滤法，阴离子交换法，阳离子交换法和反相HPLC法。 超滤方法优选包括使用具有约100千道尔顿（kD）的标称分子量截留值的膜的第一超滤步骤和使用标称分子量截留值为约10kD的膜的第二超滤步骤。 对于阴离子交换方法，使用强阳离子树脂，优选具有季胺官能团。 通常，用于阴离子交换方法的洗脱液具有约10,260 micromhos（mhos）（1.026×10 -2西门子（S））至约11,200μMhos（1.120×1031 2 S）的电导率。 对于阳离子交换方法，使用强阴离子树脂，优选具有磺酸官能团。 用于阳离子交换过程的洗脱剂通常具有约39,100m Mhos（3.91×10 -2 S）至约82,700mhos（8.27×10 -2 S）或更高的电导率。 HPLC方法通常使用含有烃改性二氧化硅填充材料的柱。 可以用乙腈溶液与三氟乙酸水溶液从HPLC柱中洗脱骨诱导蛋白。 纯化过程产生骨诱导活性蛋白质混合物。

    Osteoinductive protein mixtures and purification processes
    4.
    发明授权
    Osteoinductive protein mixtures and purification processes 失效
    骨诱导蛋白混合物和纯化方法

    公开(公告)号：US5290763A

    公开(公告)日：1994-03-01

    申请号：US689459

    申请日：1991-04-22

    申请人： James W. Poser ,  James J. Benedict

    发明人： James W. Poser ,  James J. Benedict

    IPC分类号： A61K38/00 ,  A61F2/00 ,  A61F2/02 ,  A61F2/28 ,  A61F2/32 ,  A61F2/38 ,  A61F2/44 ,  A61K38/18 ,  A61L27/02 ,  A61L27/22 ,  A61P43/00 ,  C07K14/51 ,  A61K37/02 ,  A61K37/36 ,  C07K3/02 ,  C07K15/06

    CPC分类号： C07K14/51 ,  A61F2/28 ,  A61K38/1875 ,  A61L27/025 ,  A61L27/227 ,  A61F2/32 ,  A61F2/38 ,  A61F2/4455 ,  A61F2002/30011 ,  A61F2002/30062 ,  A61F2210/0004 ,  A61F2250/0023 ,  Y10S530/84

    摘要： A method for purifying bone-derived osteoinductive factors including an ultrafiltration process, an anion exchange process, a cation exchange process, and a reverse phase HPLC process. The ultrafiltration process preferably includes a first ultrafiltration step using a membrane having a nominal molecular weight cutoff of approximately 100 kilodaltons (kD) and a second ultrafiltration step employing a membrane having a nominal molecular weight cutoff of approximately 10 kD. For the anion exchange process, a strongly cationic resin is used, preferably having quaternary amine functional groups. Typically, the eluant for the anion exchange process has a conductivity from about 10,260 micromhos (.mu.mhos) (1.026.times.10.sup.-2 siemens (S)) to about 11,200 .mu.mhos (1.120.times.10.sup.-2 S). For the cation exchange process, a strongly anionic resin is used, preferably having sulfonic acid functional groups. The eluant for the cation exchange process typically has a conductivity from about 39,100 .mu.mhos (3.91.times.10.sup.-2 S) to about 82,700 .mu.mhos (8.27.times.10.sup.-2 S) or more. The HPLC process typically utilizes a column containing hydrocarbon-modified silica packing material. The osteoinductive proteins can be eluted from the HPLC column with an acetonitrile solution in combination with aqueous trifluoracetic acid. The purification processes yield osteoinductively active protein mixtures.

    摘要翻译： 用于纯化骨衍生的骨诱导因子的方法，包括超滤法，阴离子交换法，阳离子交换法和反相HPLC法。 超滤方法优选包括使用具有约100千道尔顿（kD）的标称分子量截留值的膜的第一超滤步骤和使用标称分子量截留值为约10kD的膜的第二超滤步骤。 对于阴离子交换方法，使用强阳离子树脂，优选具有季胺官能团。 通常，用于阴离子交换方法的洗脱液具有约10,260 micromhos（（my）mhos）（1.026 * 10-2 siemens（S））至约11,200（my）mhos（1.120×10-2 S）的电导率。 对于阳离子交换方法，使用强阴离子树脂，优选具有磺酸官能团。 用于阳离子交换过程的洗脱液通常具有约39,100（my）mhos（3.91×10 -2 S）至约82,700（my）mhos（8.27×10 -2 S）或更高的电导率。 HPLC方法通常使用含有烃改性二氧化硅填充材料的柱。 可以用乙腈溶液与三氟乙酸水溶液从HPLC柱中洗脱骨诱导蛋白。 纯化过程产生骨诱导活性蛋白质混合物。

    Pliable medical device and method of use
    7.
    发明授权
    Pliable medical device and method of use 有权
    柔韧的医疗器械及使用方法

    公开(公告)号：US09101694B2

    公开(公告)日：2015-08-11

    申请号：US12086557

    申请日：2006-12-15

    申请人： James J. Benedict ,  Greg Allen Brewster ,  Donald Barclay Freeman

    发明人： James J. Benedict ,  Greg Allen Brewster ,  Donald Barclay Freeman

    IPC分类号： A61F2/00 ,  A61K38/18 ,  A61L27/52 ,  A61L27/28 ,  A61L27/56

    CPC分类号： A61L27/3608 ,  A61L27/20 ,  A61L27/28 ,  A61L27/52 ,  A61L27/54 ,  A61L27/56 ,  A61L2430/02 ,  C08L1/28

    摘要： A firm but pliable medical device for use as a bone graft substitute or bone graft extender retains its shape without the requirement of a containment device, such as a syringe. Because the device is solid, it is easy to locate or position in-vivo and, in the moist environment of the body, it will hold its shape well, for an extended time. Because the lyophilized pliable medical device is porous, it adsorbs blood and other beneficial cells containing body fluids, such as bone marrow, contributing to its superior bone repair efficacy in comparison to an analogous putty that has not been lyophilized. In addition these lyophilized pliable medical devices are easier to terminally steam sterilize than the analogous putty because there is no moisture present to boil and “blow-out” of the containment device (syringe). The glycerin that is present in the formulation lends pliability but has a low vapor pressure.

    摘要翻译： 用作骨移植物替代物或骨移植物延长剂的牢固但柔韧的医疗装置保持其形状，而不需要诸如注射器的容纳装置。 因为该装置是固体，所以很容易在体内定位或定位，并且在身体的潮湿环境中，其将保持良好的形状，长时间。 因为冻干的柔韧的医疗装置是多孔的，因此与没有被冻干的类似的腻子相比，它吸收含有体液如骨髓的血液和其它有益细胞，有助于其优异的骨修复功效。 此外，这些冻干的柔韧的医疗设备比类似的油灰更容易终止蒸汽消毒，因为不存在水分以便将容器（注射器）煮沸和“吹出”。 存在于制剂中的甘油具有柔韧性但具有低蒸气压。

    PLIABLE MEDICAL DEVICE AND METHOD OF USE
    8.
    发明申请
    PLIABLE MEDICAL DEVICE AND METHOD OF USE 有权
    可塑医疗器械及其使用方法

    公开(公告)号：US20110027332A1

    公开(公告)日：2011-02-03

    申请号：US12086557

    申请日：2006-12-15

    申请人： James J. Benedict ,  Greg Allen Brewster ,  Donald Barclay Greeman

    发明人： James J. Benedict ,  Greg Allen Brewster ,  Donald Barclay Greeman

    IPC分类号： A61F2/28 ,  A61K47/30 ,  A61K47/32 ,  A61K47/36 ,  A61K47/38 ,  A61K33/42 ,  A61K38/17 ,  A61P19/00

    CPC分类号： A61L27/3608 ,  A61L27/20 ,  A61L27/28 ,  A61L27/52 ,  A61L27/54 ,  A61L27/56 ,  A61L2430/02 ,  C08L1/28

    摘要： A firm but pliable medical device for use as a bone graft substitute or bone graft extender retains its shape without the requirement of a containment device, such as a syringe. Because the device is solid, it is easy to locate or position in-vivo and, in the moist environment of the body, it will hold its shape well, for an extended time. Because the lyophilized pliable medical device is porous, it adsorbs blood and other beneficial cells containing body fluids, such as bone marrow, contributing to its superior bone repair efficacy in comparison to an analogous putty that has not been lyophilized. In addition these lyophilized pliable medical devices are easier to terminally steam sterilize than the analogous putty because there is no moisture present to boil and “blow-out” of the containment device (syringe). The glycerin that is present in the formulation lends pliability but has a low vapor pressure.

    摘要翻译： 用作骨移植物替代物或骨移植物延长剂的牢固但柔韧的医疗装置保持其形状，而不需要诸如注射器的容纳装置。 因为该装置是固体，所以很容易在体内定位或定位，并且在身体的潮湿环境中，其将保持良好的形状，长时间。 因为冻干的柔韧的医疗装置是多孔的，因此与没有被冻干的类似的腻子相比，它吸收含有体液如骨髓的血液和其它有益细胞，有助于其优异的骨修复功效。 此外，这些冻干的柔韧的医疗设备比类似的油灰更容易终止蒸汽消毒，因为不存在水分以便将容器（注射器）煮沸和“吹出”。 存在于制剂中的甘油具有柔韧性但具有低蒸气压。

    Method of preparing a bone product by removing cancellous bone matrix
    9.
    发明授权
    Method of preparing a bone product by removing cancellous bone matrix 失效
    通过去除松质骨基质制备骨产品的方法

    公开(公告)号：US06627230B2

    公开(公告)日：2003-09-30

    申请号：US09747166

    申请日：2000-12-22

    申请人： James J. Benedict ,  Frank Fisher ,  Colin Brock

    发明人： James J. Benedict ,  Frank Fisher ,  Colin Brock

    IPC分类号： A61F228

    CPC分类号： A61K35/32 ,  A61F2/4644 ,  A61F2002/4646

    摘要： A method and apparatus for preparing a bone product are provided. The method includes contacting an interior section of a cylindrical bone portion with a high pressure fluid medium such as at least about 1000 psi to remove at least a portion of cancellous bone matrix from the bone portion. Preferably the bone contains less than about 25% by weight cancellous bone. The apparatus includes multiple stations of opposing high pressure nozzles holding the cylindrical bone portion from each end and for contacting the interior surfaces of a bone portion with a fluid medium. The apparatus also includes a third nozzle for contacting the exterior surface of the bone portion with a fluid medium.

    摘要翻译： 提供了一种用于制备骨产品的方法和装置。 该方法包括使圆柱形骨部分的内部部分与诸如至少约1000psi的高压流体介质接触以从骨部分去除至少一部分松质骨基质。 优选地，骨含有小于约25重量％的松质骨。 该装置包括相对的高压喷嘴的多个站，每个端口从每个端部保持圆柱形骨部分并且用于使骨部分的内表面与流体介质接触。 该装置还包括用于使骨部分的外表面与流体介质接触的第三喷嘴。