公开(公告)号：US20150216894A1

公开(公告)日：2015-08-06

申请号：US14614316

申请日：2015-02-04

Applicant: HemCon Medical Technologies, Inc.

Inventor： Simon McCarthy ,  Barbara McGrath ,  Sam Kuhn ,  Jess Kimball ,  Michael Stolten ,  Amanda Bennett

IPC: A61K31/722 ,  A61K9/70 ,  A61K9/16

CPC classification number: A61K31/722 ,  A61K9/1652 ,  A61K9/1694 ,  A61K9/19 ,  A61K9/70 ,  A61K47/12

Abstract: The present invention comprises chitosan materials and methods of using carbonic acid for aqueous solubilization of neutralized or pre-treated chitosan gels and provides, among other things, substantially acid salt free composition native final forms without requiring subsequent acid salt elution. The invention includes chitosan-based solid and semi-solid material forms, optionally reinforced with chitosan fibers, such as powders, fibers, films, matrices, sponges, implants, scaffolds, fillers, and hydrogels. Native final forms are produced from chitosan powder solubilized in an aqueous acidic solution, processed to form a high pH hydrated chitosan gel precipitate material that is then neutralized by water washing and re-solubilized substantially to chitosan solution using carbonic acid. Chitosan materials can be mixed in solution with one or more of other hydrophilic polymers to create compositional heterogeneity and pharmaceutical agents to achieve controlled release of the agent(s) from the final forms at the site of application.

Abstract translation: 本发明包括壳聚糖材料和使用碳酸进行中和或预处理的壳聚糖凝胶的水溶性增溶的方法，并且除其他外，还提供基本上无酸盐的组合物天然最终形式，而不需要随后的酸盐洗脱。 本发明包括任选用壳聚糖纤维如粉末，纤维，薄膜，基质，海绵，植入物，支架，填料和水凝胶增强的基于壳聚糖的固体和半固体材料形式。 天然最终形式由溶解在酸性水溶液中的壳聚糖粉末制备，加工形成高pH水合壳聚糖凝胶沉淀物质，然后通过水洗中和，并使用碳酸基本上再溶解于壳聚糖溶液。 壳聚糖材料可以与一种或多种其它亲水性聚合物在溶液中混合以产生组成异质性和药剂，以在施用部位从最终形式控制释放试剂。

公开(公告)号：US09547011B2

公开(公告)日：2017-01-17

申请号：US14211632

申请日：2014-03-14

Applicant: HemCon Medical Technologies, Inc.

Inventor： Barbara McGrath ,  Simon McCarthy ,  Sam Kuhn ,  Alysha Wold ,  Michael Stolten ,  Amanda Bennett

IPC: A61L27/20 ,  A61K47/36 ,  C08B37/08 ,  G01N33/68 ,  A61L27/26 ,  A61K9/00 ,  C08L5/08 ,  A61K49/00

CPC classification number: A61L27/58 ,  A61K9/0024 ,  A61K47/36 ,  A61K49/0008 ,  A61L27/20 ,  A61L27/26 ,  A61L2400/04 ,  C08B37/003 ,  C08L5/08 ,  C08L89/06 ,  C08L2201/06 ,  G01N33/5014 ,  G01N33/6869 ,  G01N2333/545 ,  G01N2400/28

Abstract: The invention relates to biocompatible, bioabsorbable derivatized non-crosslinked chitosan compositions optionally crosslinked to gelatin/collagen by 1-ethyl-3-[3-dimethylaminopropyl]carbodiimide hydrochloride (EDC) for biomedical use and methods of making and testing such compositions, including a modified acute systemic toxicity test. The compositions comprise derivatized chitosan reacetylated to a degree of N-deacetylation (DDA) of between about 15% and 40%. The compositions are typically bioabsorbed in about 90 days or less and can be made to bioabsorb at differing rates of speed. The compositions are initially soluble in aqueous solution below pH 6.5. The compositions have an acid content that can be adjusted between about 0% (w/w) and about 8% (w/w) to customize the composition for uses that require and/or tolerate differing levels of cytotoxicity, adhesion, composition cohesion, and cell infiltration into the composition.

Abstract translation: 本发明涉及用于生物医学使用的1-乙基-3- [3-二甲基氨基丙基]碳二亚胺盐酸盐（EDC），任选地交联至明胶/胶原的生物相容性，生物可吸收的衍生的非交联壳聚糖组合物，以及制备和测试这些组合物的方法，包括 改良型急性全身毒性试验。 组合物包含重新乙酰化至约15％至40％的N-脱乙酰度（DDA）的衍生的壳聚糖。 组合物通常在约90天或更短时间内生物吸收，并且可以以不同的速度制成生物吸收。 组合物最初可溶于低于pH6.5的水溶液中。 组合物的酸含量可以在约0％（w / w）至约8％（w / w）之间调节，以定制需要和/或耐受不同水平的细胞毒性，粘附性，组成内聚力， 和细胞浸润到组合物中。

公开(公告)号：US20160266143A1

公开(公告)日：2016-09-15

申请号：US14638770

申请日：2015-03-04

Applicant: HemCon Medical Technologies, Inc.

Inventor： Barbara McGrath ,  Simon McCarthy ,  Sam Kuhn ,  Alysha Wold ,  Michael Stolten ,  Amanda Bennett

IPC: G01N33/68 ,  A61K49/00

CPC classification number: A61L27/58 ,  A61K9/0024 ,  A61K47/36 ,  A61K49/0008 ,  A61L27/20 ,  A61L27/26 ,  A61L2400/04 ,  C08B37/003 ,  C08L5/08 ,  C08L89/06 ,  C08L2201/06 ,  G01N33/5014 ,  G01N33/6869 ,  G01N2333/545 ,  G01N2400/28

Abstract: The invention relates to biocompatible, bioabsorbable derivatized non-crosslinked chitosan compositions optionally crosslinked to gelatin/collagen by 1-ethyl-3-[3-dimethylaminopropyl]carbodiimide hydrochloride (EDC) for biomedical use and methods of making and testing such compositions, including a modified acute systemic toxicity test. The compositions comprise derivatized chitosan reacetylated to a degree of N-deacetylation (DDA) of between about 15% and 40%. The compositions are typically bioabsorbed in about 90 days or less and can be made to bioabsorb at differing rates of speed. The compositions are initially soluble in aqueous solution below pH 6.5. The compositions have an acid content that can be adjusted between about 0% (w/w) and about 8% (w/w) to customize the composition for uses that require and/or tolerate differing levels of cytotoxicity, adhesion, composition cohesion, and cell infiltration into the composition.

Abstract translation: 本发明涉及用于生物医学使用的1-乙基-3- [3-二甲基氨基丙基]碳二亚胺盐酸盐（EDC），任选地交联至明胶/胶原的生物相容性，生物可吸收的衍生的非交联壳聚糖组合物，以及制备和测试这些组合物的方法，包括 改良型急性全身毒性试验。 组合物包含重新乙酰化至约15％至40％的N-脱乙酰度（DDA）的衍生的壳聚糖。 组合物通常在约90天或更短时间内生物吸收，并且可以以不同的速度制成生物吸收。 组合物最初可溶于低于pH6.5的水溶液中。 组合物的酸含量可以在约0％（w / w）至约8％（w / w）之间调节，以定制需要和/或耐受不同水平的细胞毒性，粘附性，组成内聚力， 和细胞浸润到组合物中。

公开(公告)号：US20140275291A1

公开(公告)日：2014-09-18

申请号：US14211632

申请日：2014-03-14

Applicant: HemCon Medical Technologies, Inc.

Inventor： Barbara McGrath ,  Simon McCarthy ,  Sam Kuhn ,  Alysha Wold ,  Michael Stolten ,  Amanda Bennett

IPC: A61L27/20 ,  A61K47/36 ,  G01N33/68 ,  C08B37/08

CPC classification number: A61L27/58 ,  A61K9/0024 ,  A61K47/36 ,  A61K49/0008 ,  A61L27/20 ,  A61L27/26 ,  A61L2400/04 ,  C08B37/003 ,  C08L5/08 ,  C08L89/06 ,  C08L2201/06 ,  G01N33/5014 ,  G01N33/6869 ,  G01N2333/545 ,  G01N2400/28

Abstract: The invention relates to biocompatible, bioabsorbable derivatized non-crosslinked chitosan compositions optionally crosslinked to gelatin/collagen by 1-ethyl-3-[3-dimethylaminopropyl]carbodiimide hydrochloride (EDC) for biomedical use and methods of making and testing such compositions, including a modified acute systemic toxicity test. The compositions comprise derivatized chitosan reacetylated to a degree of N-deacetylation (DDA) of between about 15% and 40%. The compositions are typically bioabsorbed in about 90 days or less and can be made to bioabsorb at differing rates of speed. The compositions are initially soluble in aqueous solution below pH 6.5. The compositions have an acid content that can be adjusted between about 0% (w/w) and about 8% (w/w) to customize the composition for uses that require and/or tolerate differing levels of cytotoxicity, adhesion, composition cohesion, and cell infiltration into the composition.

Abstract translation: 本发明涉及用于生物医学使用的1-乙基-3- [3-二甲基氨基丙基]碳二亚胺盐酸盐（EDC），任选地交联至明胶/胶原的生物相容性，生物可吸收的衍生的非交联壳聚糖组合物，以及制备和测试这些组合物的方法，包括 改良型急性全身毒性试验。 组合物包含重新乙酰化至约15％至40％的N-脱乙酰度（DDA）的衍生的壳聚糖。 组合物通常在约90天或更短时间内生物吸收，并且可以以不同的速度制成生物吸收。 组合物最初可溶于低于pH6.5的水溶液中。 组合物的酸含量可以在约0％（w / w）至约8％（w / w）之间调节，以定制需要和/或耐受不同水平的细胞毒性，粘附性，组成内聚力， 和细胞浸润到组合物中。

公开(公告)号：US20140259724A1

公开(公告)日：2014-09-18

申请号：US13801523

申请日：2013-03-13

Applicant: HEMCON MEDICAL TECHNOLOGIES, INC.

Inventor： Simon McCarthy ,  Lisa Buckley ,  Clint Pepper ,  Ervelyn Winata ,  Barry Starkman

IPC: F26B5/06

CPC classification number: F26B5/06

Abstract: The inventive device and methods described herein address the introduction of a safe and effective freeze-dried biological product, and particularly a plasma product, to a subject in need thereof. The present invention relates to a multifunctional, staged closure device, which also is described as a lyophilization container for plasma (LCP). The device and methods described herein address how to reproducibly achieve a low moisture and substantially oxygen-free atmosphere within a finally hermetically sealed biocompatible low aspect plastic vessel within a standard shelf-stoppering freeze dryer. The present inventive device and methods provide a freeze-dried plasma product that is fully traceable, preserves the constituent plasma activity, is readily prepared in a sterile fashion, is stable, ensures ease of storage and permits rapid reconstitution and delivery to a patient.

Abstract translation: 本文所述的本发明的装置和方法涉及对有需要的受试者引入安全有效的冷冻干燥生物产品，特别是血浆产品。 本发明涉及一种多功能分级闭合装置，其也被描述为用于血浆（LCP）的冻干容器。 本文所述的装置和方法解决了如何在标准搁板冷冻干燥器内的最终气密密封的生物相容性低方位塑料容器内可再现地实现低水分和基本上无氧的气氛。 本发明的装置和方法提供了完全可追踪的冷冻干燥的血浆产品，保持了组成的血浆活性，易于以无菌方式制备，稳定，确保易于储存并且允许快速重建和递送给患者。