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1. 发明申请

WO2016094669A1 METHODS OF ORIENTING MULTIFILAMENT YARN AND MONOFILAMENTS OF POLY-4-HYDROXYBUTYRATE AND COPOLYMERS THEREOF 审中-公开
标题翻译：聚-4-羟基丁酸酯及其共聚物的多元纤维和单体的定向方法
公开(公告)号：WO2016094669A1
公开(公告)日：2016-06-16
申请号：PCT/US2015/065015
申请日：2015-12-10
申请人： TEPHA, INC.
发明人： GANATRA, Amit , FELIX, Fabio , SHAH, Bhavin , BERNASCONI, Matthew , RIZK, Said , MARTIN, David, P. , WILLIAMS, Simon, F.
IPC分类号： D01F6/62
CPC分类号： D01F6/625 , A61L17/105 , A61L31/06 , A61L31/148 , B29C55/005 , B29K2073/00 , B29K2673/00 , B29L2031/731 , D01D5/08 , D01F8/14 , D02G3/04 , D10B2331/04 , D10B2331/041 , D10B2401/063 , D10B2509/04 , D10B2509/08
摘要： Resorbable multifilament yams and monofilament fibers including poly-4-hydroxybutyrate and copolymers thereof with high tenacity or high tensile strength have been developed. The yams and fibers are produced by cold drawing the multifilament yams and monofilament fibers before hot drawing the yams and fibers under tension at temperatures above the melt temperature of the polymer or copolymer. These yams and fibers have prolonged strength retention in vivo making them suitable for soft tissue repairs where high strength and strength retention is required. The multifilament yams have tenacities higher than 8.1 grams per denier, and in vivo , retain at least 65% of their initial strength at 2 weeks. The monofilament fibers retain at least 50% of their initial strength at 4 weeks in vivo . The monofilament fibers have tensile strengths higher than 500 MPa. These yams and fibers may be used to make various medical devices for various applications.
摘要翻译：已经开发了可再吸收的复丝纱线和包括聚-4-羟基丁酸酯的单丝纤维及其具有高强度或高拉伸强度的共聚物。在高于聚合物或共聚物的熔融温度的温度下，在拉伸纱线和纤维的拉伸下，通过冷拉丝复丝纱线和单丝纤维来生产纱线和纤维。这些纱线和纤维在体内具有延长的强度保持性，使得它们适用于需要高强度和强度保持性的软组织修复。复丝纱具有高于8.1克/旦尼尔的强度，并且体内在2周时保持其初始强度的至少65％。单丝纤维在体内4周时保持其初始强度的至少50％。单丝纤维的拉伸强度高于500MPa。这些纱线和纤维可用于制造用于各种应用的各种医疗装置。

2. 发明申请

WO2009085823A1 MEDICAL DEVICES CONTAINING MELT-BLOWN NON-WOVENS OF POLY-R-HYDROXYBUTYRATE AND COPOLYMERS 审中-公开
标题翻译：含有聚R-羟基丁酸酯和共聚物的熔融非织造物的医疗装置
公开(公告)号：WO2009085823A1
公开(公告)日：2009-07-09
申请号：PCT/US2008/087159
申请日：2008-12-17
申请人： TEPHA, INC. , HO, Kicherl , WILLIAMS, Simon, F. , RIZK, Said , MARTIN, David, P.
发明人： HO, Kicherl , WILLIAMS, Simon, F. , RIZK, Said , MARTIN, David, P.
IPC分类号： D04H1/56 , A61L17/10
CPC分类号： A61L29/06 , A61L15/26 , A61L15/44 , A61L27/18 , A61L27/54 , A61L29/16 , A61L31/06 , A61L31/10 , A61L31/16 , A61L2300/00 , D04H1/4382 , D04H1/56 , Y10T442/608 , C08L67/04
摘要： Continuous processing methods for making absorbable polymeric non- wovens with one or more of the following properties: high burst strength, fine fibers of average diameter from 1 μm to 50 μm, and thickness from 10 μm to 50 mm, have been developed. Improved fiber cohesion is made possible by allowing the fibers of the non-woven to initially remain molten during web collection. In the preferred embodiment, the polymer is a polyhydroxyalkanoate, and in the most preferred embodiment, the polymer comprises 4- hydroxybutyrate. A particularly preferred embodiment is a non-woven of poly- 4-hydroxybutyrate or copolymer thereof, wherein the non-woven has a burst strength greater than 0.1 Kgf, wherein the non- woven is derived by a continuous melt-blown process. The non-wovens can be used for a variety of purposes including fabrication of medical devices.
摘要翻译：已经开发了用于制造具有以下特性中的一种或多种的可吸收聚合非织造物的连续加工方法：高爆裂强度，平均直径为1μm至50μm的细纤维和厚度为10μm至50mm。通过允许无纺布的纤维在网收集期间最初保持熔融，可以实现改进的纤维内聚力。在优选的实施方案中，聚合物是聚羟基链烷酸酯，并且在最优选的实施方案中，聚合物包含4-羟基丁酸酯。特别优选的实施方案是聚-4-羟基丁酸酯或其共聚物的无纺布，其中无纺布具有大于0.1Kgff的破裂强度，其中无纺织物通过连续熔喷法得到。无纺布可以用于各种目的，包括制造医疗装置。

3. 发明申请

WO2022240725A1 NIPPLE RECONSTRUCTION IMPLANT 审中-公开
公开(公告)号：WO2022240725A1
公开(公告)日：2022-11-17
申请号：PCT/US2022/028284
申请日：2022-05-09
申请人： TEPHA, INC.
发明人： LIMEM, Skander , SARIIBRAHIMOGLU, Kemal , SCOTT, Jeffrey Robert , WILLIAMS, Simon, F.
IPC分类号： A61F2/12 , A61F2/00 , A61L27/14 , A61F2/0059 , A61F2/0063 , A61F2210/0004 , A61F2230/0093 , A61F2240/001 , A61F2250/0023 , A61F2250/0067 , A61L2430/04 , A61L27/18 , A61L27/56
摘要： Absorbable implants can be used to reconstruct the nipple with regenerated tissue resulting in improved aesthetic satisfaction. The implants are particularly suitable for use in plastic surgery procedures, for example, to reconstruct the nipple following total mastectomy and breast reconstruction. The implants may be formed from absorbable mesh and/or dry spun sheet.

4. 发明申请

WO2022225798A1 MULTI-COMPONENT BREAST IMPLANT 审中-公开
公开(公告)号：WO2022225798A1
公开(公告)日：2022-10-27
申请号：PCT/US2022/024954
申请日：2022-04-15
申请人： TEPHA, INC.
发明人： LIMEM, Skander , SARIIBRAHIMOGLU, Kemal , BUTLER, Timothy, John , WILLIAMS, Simon, F.
IPC分类号： A61F2/12 , B33Y80/00 , A61L27/56 , A61L27/58
摘要： Absorbable implants can be used to create volume and shape in the breast of a patient with regenerated tissue. The implants are transient comprising a reinforced matrix comprising a load bearing absorbable macroporous network with an open pore structure, at least partially filled with one or more degradable hydrogels or water-soluble polymers that degrade progressively, from the surface of the implant towards the core of the implant, and direct tissue ingrowth in the same direction. The hydrogels and water-soluble polymers help prevent fluid accumulation in the implant prior to tissue ingrowth. The macroporous networks are absorbed after tissue ingrowth has occurred, and a load bearing support is no longer necessary. The implants are particularly suitable for use in plastic surgery procedures, for example, to regenerate or augment breast tissue following mastectomy or in mastopexy procedures, and can provide an alternative to the use of permanent breast implants in these procedures.

5. 发明申请

WO2016025329A1 SELF-RETAINING SUTURES OF POLY-4-HYDROXYBUTYRATE AND COPOLYMERS THEREOF 审中-公开
标题翻译：聚-4-羟基丁酸酯及其共聚物的自保留物
公开(公告)号：WO2016025329A1
公开(公告)日：2016-02-18
申请号：PCT/US2015/044280
申请日：2015-08-07
申请人： TEPHA, INC.
发明人： RIZK, Said , WILLIAMS, Simon, F.
IPC分类号： A61L27/18 , A61L31/06 , A61L17/10
CPC分类号： A61L17/105 , A61B17/06166 , A61B2017/00004 , A61B2017/00526 , A61B2017/06176 , A61L17/12 , A61L27/18 , A61L31/06 , C08L67/04
摘要： Absorbable monofilament fibers and self-retaining sutures with high tensile strengths have been developed. The straight pull tensile strengths of the absorbable self-retaining sutures closely approximate, equal or exceed the average minimum knot-pull tensile standards set by the United States Pharmacopeia (USP). These higher strength absorbable self-retaining sutures can therefore be used either without needing to oversize the suture for a given procedure, or by oversizing the self-retaining suture by no more than 0.1 mm in diameter. In one embodiment, the absorbable self-retaining sutures are made from poly-4-hydroxybutyrate or copolymers thereof. Methods for producing absorbable self-retaining sutures that have high tensile strengths and pronounced sheath-core structures wherein the sheath is harder than the core are also provided. The self-retaining sutures may be made by spinning and orienting a monofilament fiber of poly-4- hydroxybutyrate or copolymer thereof and inserting retainers in monofilament fibers.
摘要翻译：已经开发了具有高拉伸强度的可吸收的单丝纤维和自固位缝合线。可吸收自固位缝合线的直拉拉伸强度接近于等于或超过美国药典（USP）制定的平均最小打结拉伸标准。因此，这些较高强度的可吸收自固位缝合线既可以用于给定的过程，也可以不需要超大缝线，或者通过将自固位缝合线的尺寸设定为不超过0.1mm的直径。在一个实施方案中，可吸收的自固位缝线由聚-4-羟基丁酸酯或其共聚物制成。还提供了用于制造具有高拉伸强度和明显的皮芯结构的可吸收自固定缝合线的方法，其中鞘比芯更硬。自固位缝线可以通过将聚-4-羟基丁酸酯或其共聚物的单丝纤维进行纺丝和定向并将保持剂插入单丝纤维中来制备。

6. 发明申请

WO2015167807A1 THREE-DIMENSIONAL RESORBABLE IMPLANTS FOR TISSUE REINFORCEMENT AND HERNIA REPAIR 审中-公开
标题翻译：用于组织加固和HERNIA修复的三维可折叠植入物
公开(公告)号：WO2015167807A1
公开(公告)日：2015-11-05
申请号：PCT/US2015/026005
申请日：2015-04-15
申请人： TEPHA, INC.
发明人： RIZK, Said , FOSCO, Antonio , GANATRA, Amit , MARTIN, David, P. , WILLIAMS, Simon, F.
IPC分类号： A61F2/00
CPC分类号： A61F2/0063 , A61F2230/0093 , A61F2240/004
摘要： Resorbable three-dimensional implants that can be temporarily deformed, implanted by minimally invasive means, and resume their original shape in vivo, have been developed. These implants are particularly suitable for use in minimally invasive procedures for tissue reinforcement, repair of hernias, and applications where it is desirable for the implant to contour in vivo to an anatomical shape, such as the inguinofemoral region. In the preferred embodiment, the implants are made from meshes of poly -4- hydroxybutyrate monofilament that have reinforced outlying borders that allow the meshes to form three-dimensional shapes that can be temporarily deformed. These implants can resume three-dimensional shapes after being temporarily deformed that contour to the host's tissue or an anatomical shape, for example, in the repair of a hernia, and particularly a hernia in the inguinofemoral region. The implants can contour to the host's tissue for example, of the inguinofemoral region, without the implants wrinkling, bunching or folding.
摘要翻译：已经开发了可以暂时变形，通过微创手段植入并在体内恢复其原始形状的可再吸收的三维植入物。这些植入物特别适用于用于组织加强，疝修补的微创手术，以及其中期望植入物在体内轮廓到解剖学形状（例如腹股沟区域）的应用。在优选实施例中，植入物由聚-4-羟基丁酸酯单丝的网格制成，其具有增强的外围边界，允许网格形成可暂时变形的三维形状。这些植入物可以在将轮廓暂时变形成主体的组织或解剖形状之后恢复三维形状，例如修复疝气，特别是在腹股沟区域中的疝。植入物可以轮廓到宿主的组织，例如，腹股沟区域，而没有植入物起皱，聚束或折叠。

7. 发明申请

WO2021126638A1 RESORBABLE IMPLANTS FOR RECONSTRUCTION OF BONE DEFECTS 审中-公开
公开(公告)号：WO2021126638A1
公开(公告)日：2021-06-24
申请号：PCT/US2020/064102
申请日：2020-12-09
申请人： TEPHA, INC.
发明人： SARIIBRAHIMOGLU, Kemal , LIMEM, Skander , GANATRA, Amit , RIZK, Said , WILLIAMS, Simon, F.
IPC分类号： A61F2/28 , A61F2/30 , A61L31/06 , A61F2/2875 , A61F2/3094 , A61F2002/30032 , A61F2002/30062 , A61F2002/30113 , A61F2002/30224 , A61F2002/30233 , A61F2002/30235 , A61F2002/30299 , A61F2002/30322 , A61F2002/30354 , A61F2002/30405 , A61F2002/30784 , A61F2002/30892 , A61F2002/30914 , A61F2002/30915 , A61F2002/30971 , A61F2002/30985 , A61F2310/00179 , A61L2430/02 , A61L27/18 , A61L27/58 , A61L31/026 , A61L31/146 , A61L31/148 , C08K3/346
摘要： Devices (200) to repair bone defects prevent the formation of depressions and palpable tissue at bone repair sites. The devices can be used to repair burr holes in the cranium, providing an improved cosmetic result that reduces or eliminates functional handicaps that can result from combing and hairdressing. The devices are secured in bone defects with filament elements (210), by expanding the device inside the bone defect, or by gluing. Tissue in-growth into the device regenerates bone at the defect site, and prevents the formation of depressions or palpable tissue. The devices preferably comprise a ceramic and poly-4-hydroxybutyrate or copolymer thereof, or a ceramic and poly (butylene succinate) or copolymer thereof.

8. 发明申请

WO2016048950A1 ORIENTED P4HB IMPLANTS CONTAINING ANTIMICROBIAL AGENTS 审中-公开
标题翻译：面向抗菌剂的P4HB植入物
公开(公告)号：WO2016048950A1
公开(公告)日：2016-03-31
申请号：PCT/US2015/051338
申请日：2015-09-22
申请人： TEPHA, INC.
发明人： MARTIN, David, P. , RIZK, Said , WILLIAMS, Simon, F. , MOSES, Arikha
IPC分类号： A61L27/18 , C08L67/04
CPC分类号： A61L31/06 , A61L27/18 , A61L31/08 , A61L31/16 , A61L2300/404 , A61L2420/02 , A61L2420/06
摘要： Oriented resorbable implants made from poly-4-hydroxybutyrate (P4HB) and copolymers thereof, have been developed that contain one or more antimicrobial agents to prevent colonization of the implants, and reduce or prevent the occurrence of infection following implantation in a patient. These oriented implants are particularly suitable for use in procedures where prolonged strength retention is necessary and there is a risk of infection. Coverings and receptacles made from poly-4- hydroxybutyrate and copolymers thereof, containing antimicrobial agents, have also been developed for use with implantable devices to prevent colonization of these devices, and to reduce or prevent the occurrence of infection following implantation of these devices in a patient. These coverings and receptacles may be used to hold, or partially or fully cover, devices such as pacemakers and neurostimulators. Preferably, the coverings and receptacles are made from meshes, non-wovens, films, fibers, and foams, and contain rifampin and minocycline.
摘要翻译：已经开发了由聚-4-羟基丁酸酯（P4HB）及其共聚物制成的定向可吸收植入物，其含有一种或多种抗微生物剂以防止植入物的定植，并且在植入患者体内减少或防止感染的发生。这些定向植入物特别适用于需要延长强度保留并且存在感染风险的程序。含有抗微生物剂的聚-4-羟基丁酸酯及其共聚物制成的覆盖物和容器也被开发用于可植入的装置以防止这些装置的定植，并且减少或防止这些装置植入后的感染的发生患者。这些覆盖物和容器可用于保持或部分或完全覆盖诸如起搏器和神经刺激器的装置。优选地，覆盖物和容器由网状物，无纺布，膜，纤维和泡沫制成，并且含有利福平和米诺环素。

9. 发明申请

WO2015100120A1 MEDICAL IMPLANTS INCLUDING LAMINATES OF POLY-4-HYDROXYBUTYRATE AND COPOLYMERS THEREOF 审中-公开
标题翻译：包括聚-4-羟基丁酸酯及其共聚物的层合物的医用植入物
公开(公告)号：WO2015100120A1
公开(公告)日：2015-07-02
申请号：PCT/US2014/071073
申请日：2014-12-18
申请人： TEPHA, INC.
发明人： RIZK, Said , MARTIN, David, P. , FELIX, Fabio , BERNASCONI, Matthew , SHAH, Bhavin , WILLIAMS, Simon, F.
IPC分类号： A61L27/18
CPC分类号： A61L31/06 , A61L27/18 , A61L31/146 , A61L31/16 , B29C43/28 , B29K2067/04 , B29L2009/00 , C08G63/06 , Y10T428/1393 , Y10T428/24322 , Y10T428/249921 , Y10T442/10 , Y10T442/183 , Y10T442/184 , C08L67/04
摘要： Methods to produce laminates including layers of constructs made from P4HB and copolymers thereof have been developed. These laminates may be used as medical implants, or further processed to make medical implants. The laminates are produced at a temperature equal to or greater than the softening points of the P4HB or copolymers thereof. The layers may include oriented forms of the constructs. Orientation can be preserved during lamination so that the laminate is also oriented, when the laminates are formed at temperatures less than the de-orientation temperatures of the layers. The laminate layers may include, for example, films, textiles, including woven, knitted, braided and non-woven textiles, foams, thermoforms, and fibers. The laminates preferably include one or more oriented P4HB films.
摘要翻译：已经开发了生产层压材料的方法，包括由P4HB制成的构造层及其共聚物。这些层压体可用作医疗植入物，或进一步加工成医用植入物。层压体在等于或大于P4HB或其共聚物的软化点的温度下生产。这些层可以包括定向形式的构建体。当层压体形成的温度低于层的去取向温度时，可以在层压过程中保持取向，使层压板也定向。层压层可以包括例如薄膜，纺织品，包括织造，针织，编织和非织造纺织品，泡沫，热成型和纤维。层压体优选包括一个或多个取向的P4HB膜。

10. 发明申请

WO2015069556A1 COMPOSITIONS AND DEVICES OF POLY-4-HYDROXYBUTYRATE 审中-公开
标题翻译：聚-4-羟基丁酸酯的组合物和装置
公开(公告)号：WO2015069556A1
公开(公告)日：2015-05-14
申请号：PCT/US2014/063305
申请日：2014-10-31
申请人： TEPHA, INC.
发明人： MARTIN, David, P. , WILLIAMS, Simon, F.
IPC分类号： A61L27/18 , A61L27/34 , A61L31/06 , A61L31/10 , A61L17/10 , C12P7/62 , C08L67/04
CPC分类号： A61L31/06 , A61L17/105 , A61L27/18 , A61L27/34 , A61L31/10 , C08G63/06 , C08G63/90 , C12P7/625 , G01N33/5088 , Y10T436/201666 , C08L67/04
摘要： Compositions of P4HB with high purity have been developed. The compositions are prepared by washing P4HB biomass prior to solvent extraction, and precipitating P4HB from solution. The same solvent is preferably used to wash the P4HB biomass, and as a non-solvent to precipitate the polymer from a P4HB solvent solution. The highly pure P4HB compositions are suitable for preparing implants. The implants may be used for the repair of soft and hard tissues.
摘要翻译：已经开发了高纯度的P4HB组合物。通过在溶剂萃取之前洗涤P4HB生物质并从溶液中沉淀出P4HB来制备组合物。优选使用相同的溶剂来洗涤P4HB生物质，并且作为非溶剂以从P4HB溶剂溶液中沉淀聚合物。高纯度的P4HB组合物适用于制备植入物。植入物可用于修复软组织和硬组织。

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