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31. 发明授权

US5505699A Angioplasty device 失效
标题翻译：血管成形术装置
公开(公告)号：US5505699A
公开(公告)日：1996-04-09
申请号：US217306
申请日：1994-03-24
申请人： Michael R. Forman , Michael N. Helmus , Joseph E. Laptewicz, Jr.
发明人： Michael R. Forman , Michael N. Helmus , Joseph E. Laptewicz, Jr.
IPC分类号： A61M25/00 , A61F2/82 , A61M29/02 , A61M29/00
CPC分类号： A61M25/104 , A61M2025/0186 , A61M2025/09141 , A61M2025/1015 , A61M2025/1093
摘要： This invention relates to an angioplasty device that is formed from a hollow metallic tube, a balloon affixed adjacent the distal end of the tube and being in fluid communication with the lumen of the tube, a flexible distal segment connected to the distal end of the tube and a removable hub connected adjacent to the proximal end of the tube. The tube is preferably formed from a superelastic material such as nickel-titanium alloy. This invention also relates to various methods of using this angioplasty device.
摘要翻译：本发明涉及一种由中空金属管形成的血管成形术装置，邻近管的远端固定并与管的内腔流体连通的球囊，连接到管的远端的柔性远端段以及与管的近端相邻连接的可移除的轮毂。该管优选由诸如镍 - 钛合金的超弹性材料形成。本发明还涉及使用该血管成形术装置的各种方法。

32. 发明授权

US08535702B2 Medical devices having porous polymeric regions for controlled drug delivery and regulated biocompatibility 有权
标题翻译：具有用于受控药物递送和调节的生物相容性的多孔聚合物区域的医疗装置
公开(公告)号：US08535702B2
公开(公告)日：2013-09-17
申请号：US11048616
申请日：2005-02-01
申请人： Robert E. Richard , Frederick H. Strickler , Marlene C. Schwarz , Rudolf Faust , Shrirang V. Ranade , Michael N. Helmus
发明人： Robert E. Richard , Frederick H. Strickler , Marlene C. Schwarz , Rudolf Faust , Shrirang V. Ranade , Michael N. Helmus
IPC分类号： A61F2/00
CPC分类号： A61L31/129 , A61L27/48 , A61N1/05
摘要： The present invention relates to phase separated polymeric regions and to their use in conjunction with implantable or insertable medical devices. In some aspects of the invention, phase separated polymeric regions are provided that include (a) at least one biostable polymeric phase and (b) at least one biodisintegrable polymeric phase, which is of nanoscale dimensions and which undergoes biodisintegration such that the phase separated polymeric region becomes a nanoporous polymeric region in vivo. Other aspects of the invention are directed to methods of making implantable or insertable medical devices having at least one nanoporous polymeric region. These methods include (a) providing a phase separated polymeric region comprising a stable polymeric phase and a disintegrable polymeric phase of nanoscale dimensions, (b) selectively removing the disintegrable polymeric phase thereby producing the nanoporous polymeric region. In still other aspects, implantable or insertable medical devices are provided which have phase separated polymeric regions that include (a) at least one block copolymer having at least one biostable polymer block and at least one biodisintegrable polymer block and (b) at least one therapeutic agent which is released in vivo upon implantation or insertion of the medical device.
摘要翻译：本发明涉及相分离的聚合物区域以及它们与可植入或可插入的医疗装置结合使用。在本发明的一些方面，提供了相分离的聚合物区域，其包括（a）至少一个生物稳定的聚合物相和（b）至少一个具有纳米级尺寸并且经历生物整合的生物分解聚合物相，并且经历相分离的聚合物区域在体内成为纳米孔聚合物区域。本发明的其它方面涉及制造具有至少一个纳米多孔聚合物区域的可植入或可插入医疗器械的方法。这些方法包括（a）提供包含稳定聚合物相和纳米尺度的可分解聚合物相的相分离聚合物区域，（b）选择性地除去可分解的聚合物相，从而制备纳米多孔聚合物区域。在另外的方面，提供了可植入或可插入的医疗装置，其具有相分离的聚合物区域，其包括（a）至少一种具有至少一种生物稳定聚合物嵌段和至少一种生物可分解聚合物嵌段的嵌段共聚物和（b）至少一种治疗在植入或插入医疗装置时在体内释放的药剂。

33. 发明授权

US08236241B2 Treating biological tissues to mitigate post-implantation calcification 有权
标题翻译：治疗生物组织以减轻植入后钙化
公开(公告)号：US08236241B2
公开(公告)日：2012-08-07
申请号：US11744614
申请日：2007-05-04
申请人： Alain F. Carpentier , Sophie Carpentier , Crystal M. Cunanan , Lillian J. Quintero , Michael N. Helmus , Christine Loshbaugh , H. Chris Sarner
发明人： Alain F. Carpentier , Sophie Carpentier , Crystal M. Cunanan , Lillian J. Quintero , Michael N. Helmus , Christine Loshbaugh , H. Chris Sarner
IPC分类号： A61L2/00 , A61F2/02
CPC分类号： A61L27/3691 , A61L2/0088 , A61L27/3604 , A61L27/3641 , A61L27/3645 , A61L27/3683 , A61L27/3687 , A61L33/12 , A61L2400/02 , A61L2430/40 , Y10S623/901 , Y10S623/915 , Y10S623/917 , Y10S623/92
摘要： A method of treating a biological tissue including crosslinking with glutaraldehyde; immersing the biological tissue in a first solution containing glutaraldehyde and heat in the first solution to a temperature of about 50° C. for a first period of time; immersing the biological tissue in a second solution containing a mixture of a crosslinking agent, a denaturing agent and a surfactant; and immersing the biological tissue in a sterilizing solution containing glutaraldehyde and heating the sterilizing solution to a temperature of 37.5±2.5° C. for a sterilizing period of time. The method may include a terminal sterilization step in a method for fixation of biological tissues, and bioprosthetic devices may be prepared by such fixation method. The fixation method may include the steps of A) fixing the tissue, B) treating the tissue with a mixture of i) a denaturant, ii) a surfactant and iii) a crosslinking agent, C) fabricating or forming the bioprosthesis (e.g., forming the tissue and attaching any non-biological components thereto) and D) subjecting the bioprosthesis to the terminal sterilization method.
摘要翻译：一种治疗生物组织的方法，包括用戊二醛交联; 将生物组织浸入含有戊二醛的第一溶液中并在第一溶液中加热至约50℃的温度持续第一时间; 将生物组织浸渍在含有交联剂，变性剂和表面活性剂的混合物的第二溶液中; 将生物体组织浸渍在含有戊二醛的杀菌溶液中并将灭菌液加热至37.5±2.5℃的温度进行杀菌的时间。该方法可以包括用于固定生物组织的方法中的终端灭菌步骤，并且生物假体装置可以通过这种固定方法制备。固定方法可以包括以下步骤：A）固定组织，B）用i）变性剂，ii）表面活性剂和iii）交联剂的混合物处理组织，C）制造或形成生物假体（例如，形成组织并附着任何非生物组分）和D）使生物假体进行终末灭菌方法。

34. 发明授权

US08092818B2 Medical devices having bioactive surfaces 有权
标题翻译：具有生物活性表面的医疗器械
公开(公告)号：US08092818B2
公开(公告)日：2012-01-10
申请号：US11435799
申请日：2006-05-17
申请人： Robert E. Richard , Michael N. Helmus
发明人： Robert E. Richard , Michael N. Helmus
IPC分类号： A61F2/02 , A61K9/00 , A61K47/32 , A61K38/04 , A61K38/06 , A61K38/08 , A61K31/726
CPC分类号： A61L27/54 , A61L27/34 , A61L29/085 , A61L29/16 , A61L31/10 , A61L31/16 , A61L2300/00 , C08L53/00
摘要： According to an aspect of the present invention, medical devices are provided, which contain (a) a substrate and (b) a polymeric region disposed over the substrate which contains at least one block copolymer. The block copolymer, in turn, contains at least two polymer blocks which phase separate into two or more immiscible phase domains within the polymeric region. Moreover, a bioactive species is covalently attached to at least one of the polymer blocks. By attaching the bioactive species selectively to at least one polymer block, self-assembled clusters of the bioactive species are created as the blocks phase separate into immiscible phase domains.
摘要翻译：根据本发明的一个方面，提供了包含（a）基底和（b）设置在基底上的包含至少一种嵌段共聚物的聚合物区域的医疗装置。嵌段共聚物又包含至少两个聚合物嵌段，其相分离成聚合物区域内的两个或多个不混溶的相域。此外，生物活性物质共价连接至至少一个聚合物嵌段。通过将生物活性物质选择性地附着到至少一个聚合物嵌段上，随着块相分离成不混溶的相域，产生生物活性物质的自组装簇。

35. 发明申请

US20110014264A1 Medical Devices Having Nanostructured Regions For Controlled Tissue Biocompatibility And Drug Delivery 审中-公开
标题翻译：具有控制组织生物相容性和药物递送的纳米结构区域的医疗器械
公开(公告)号：US20110014264A1
公开(公告)日：2011-01-20
申请号：US12888864
申请日：2010-09-23
申请人： Michael N. Helmus , Yixin Xu , Shrirang V. Ranade
发明人： Michael N. Helmus , Yixin Xu , Shrirang V. Ranade
IPC分类号： A61F2/82 , A61M31/00 , A61K38/02 , A61K31/726 , A61P43/00 , A61P35/00
CPC分类号： B82Y30/00 , A61L27/50 , A61L27/54 , A61L27/56 , A61L2300/236 , A61L2300/252 , A61L2300/416 , A61L2300/42 , A61L2300/45 , A61L2300/624 , A61N1/05 , B82Y5/00
摘要： According to certain aspects of the invention, implantable or insertable medical devices are provided that contain one or more nanoporous regions, which may further comprise interconnected nanopores. Other aspects of the invention are directed to implantable or insertable medical devices that contain one or more nanostructured regions, which are formed by a variety of methods. Still other aspects of the invention are directed to implantable or insertable medical devices having nanotextured surface regions, in which cell-adhesion-promoting biomolecules (e.g., glycosaminoglycans, proteoglycans, cell adhesion peptides, and adhesive proteins) are provided on, within or beneath the nanotextured surface regions.
摘要翻译：根据本发明的某些方面，提供了可植入或可插入的医疗装置，其包含一个或多个纳米多孔区域，其可以进一步包括互连的纳米孔。本发明的其它方面涉及含有一个或多个纳米结构区域的可植入或可插入的医疗装置，其通过多种方法形成。本发明的另外其它方面涉及具有纳米纹理表面区域的可植入或可插入的医疗装置，其中提供细胞粘附促进生物分子（例如，糖胺聚糖，蛋白聚糖，细胞粘附肽和粘合蛋白），其中，纳米纹理表面区域。

36. 发明授权

US07767220B2 Implantable or insertable medical articles having covalently modified, biocompatible surfaces 有权
标题翻译：具有共价修饰的生物相容表面的可植入或可插入的医疗制品
公开(公告)号：US07767220B2
公开(公告)日：2010-08-03
申请号：US10830772
申请日：2004-04-23
申请人： Shrirang V. Ranade , Michael N. Helmus
发明人： Shrirang V. Ranade , Michael N. Helmus
IPC分类号： A61F2/02 , A61F2/00 , A61K47/00
CPC分类号： A61L29/16 , A61L27/34 , A61L27/54 , A61L29/085 , A61L31/10 , A61L31/16 , A61L2300/606 , A61L2400/18
摘要： Implantable or insertable medical devices comprising a surface region that is modified by covalently coupling a molecular species (or a combination of molecular species) to the same. The molecular species are selected such that the resulting modified surface region has critical surface energy between 20 and 30 dynes/cm. In certain embodiments, the covalently coupled molecular species comprise one or more methyl groups. An advantage of the present invention is that novel medical devices are provided, which have a surface with a critical surface energy value that has been shown to display enhanced biocompatibility, including enhanced thromboresistance, relative to other surfaces.
摘要翻译：可植入或可插入的医疗装置包括通过共价地将分子种类（或分子种类的组合）共价连接到其上的表面区域。选择分子种类，使得所得到的改性表面区域具有20至30达因/厘米的临界表面能。在某些实施方案中，共价偶联的分子种类包含一个或多个甲基。本发明的一个优点是提供了新的医疗装置，其具有表面具有临界表面能值，该表面已显示出相对于其它表面显示增强的生物相容性，包括增强的血栓阻力。

37. 发明申请

US20080208325A1 Medical articles for long term implantation 审中-公开
标题翻译：医疗用品长期植入
公开(公告)号：US20080208325A1
公开(公告)日：2008-08-28
申请号：US12072141
申请日：2008-02-25
申请人： Michael N. Helmus , Barron Tenney , Yixin Xu , Kevin M. Alves , Frederick H. Strickler , Kathleen M. Miller , Mark Boden
发明人： Michael N. Helmus , Barron Tenney , Yixin Xu , Kevin M. Alves , Frederick H. Strickler , Kathleen M. Miller , Mark Boden
IPC分类号： A61F2/06
CPC分类号： A61F2/07 , A61F2/06 , A61F2/915 , A61F2002/009 , A61F2002/072 , A61F2002/075 , A61F2250/0024 , A61L27/427 , A61L27/56 , A61L31/128 , A61L31/146
摘要： According to an aspect of the present invention, long term medical articles are provided which include the following: (a) first and second body contacting (e.g., tissue and/or body-fluid contacting) porous polymeric layers; (b) a polymeric barrier layer disposed between the first and second porous polymer layers; and (c) a reinforcement element. According to another aspect of the present invention, tubular medical articles for long term implantation are provided, which comprise: (a) a reinforcement element; (b) a blood contacting porous polymeric layer having a surface energy ranging between 20 and 30 dynes/cm disposed over an inner surface of the reinforcement element; and (c) an additional porous polymeric layer formed over an outer surface of the reinforcement element.
摘要翻译：根据本发明的一个方面，提供了长期的医疗制品，其包括以下：（a）第一和第二体接触（例如组织和/或体液接触）多孔聚合物层; （b）设置在第一和第二多孔聚合物层之间的聚合物阻挡层; 和（c）增强元件。根据本发明的另一方面，提供了用于长期植入的管状医疗制品，其包括：（a）增强元件; （b）设置在增强元件的内表面上的表面能范围在20和30达因/厘米之间的血液接触多孔聚合物层; 和（c）在增强元件的外表面上形成的另外的多孔聚合物层。

38. 发明授权

US07214344B2 Method for treatment of biological tissues to mitigate post-implantation calcification and thrombosis 有权
标题翻译：用于治疗生物组织以减轻植入后钙化和血栓形成的方法
公开(公告)号：US07214344B2
公开(公告)日：2007-05-08
申请号：US10345120
申请日：2003-01-14
申请人： Alain F. Carpentier , Sophie Carpentier , Crystal M. Cunanan , Lillian J. Quintero , Michael N. Helmus , Christine Loshbaugh , H. Chris Sarner
发明人： Alain F. Carpentier , Sophie Carpentier , Crystal M. Cunanan , Lillian J. Quintero , Michael N. Helmus , Christine Loshbaugh , H. Chris Sarner
IPC分类号： A61L2/00
CPC分类号： A61L27/3691 , A61L2/0088 , A61L27/3604 , A61L27/3641 , A61L27/3645 , A61L27/3683 , A61L27/3687 , A61L33/12 , A61L2400/02 , A61L2430/40 , Y10S623/901 , Y10S623/915 , Y10S623/917 , Y10S623/92
摘要： A method of treating a biological tissue including contacting the biological tissue with an aqueous sterilizing solution, and maintaining the aqueous sterilizing solution at a temperature of about 50° C. for a time period of about 1 to 2 days. The method of treating a biological tissue may be utilized as a terminal sterilization step in a method for fixation of biological tissues, and bioprosthetic devices may be prepared by such fixation method. The fixation method may include the steps of A) fixing the tissue, B) treating the tissue with a mixture of i) a denaturant, ii) a surfactant and iii) a crosslinking agent, C) fabricating or forming the bioprosthesis (e.g., forming the tissue and attaching any non-biological components thereto) and D) subjecting the bioprosthesis to the terminal sterilization method. The aqueous sterilizing solution may be glutaraldehyde of about 0.625 weight percent buffered to a pH of about 7.4.
摘要翻译：一种处理生物组织的方法，包括使生物组织与含水灭菌溶液接触，并将水性杀菌溶液保持在约50℃的温度下约1至2天的时间。生物组织的处理方法可以用作生物组织固定方法中的末端灭菌步骤，并且可以通过这种固定方法制备生物假体装置。固定方法可以包括以下步骤：A）固定组织，B）用i）变性剂，ii）表面活性剂和iii）交联剂的混合物处理组织，C）制造或形成生物假体（例如，形成组织并附着任何非生物组分）和D）使生物假体进行终末灭菌方法。含水灭菌溶液可以是约0.625重量％的戊二醛缓冲至约7.4的pH。

39. 发明授权

US06503224B1 Perfusion balloon catheter 有权
标题翻译：灌注气囊导管
公开(公告)号：US06503224B1
公开(公告)日：2003-01-07
申请号：US09631750
申请日：2000-08-04
申请人： Michael R. Forman , Jonathan S. Stinson , Michael N. Helmus
发明人： Michael R. Forman , Jonathan S. Stinson , Michael N. Helmus
IPC分类号： A61M2900
CPC分类号： A61M25/104 , A61B2017/00685 , A61M1/101 , A61M1/1018 , A61M1/1036 , A61M1/122 , A61M1/125 , A61M1/127 , A61M25/00 , A61M29/02 , A61M2025/1095
摘要： A balloon catheter having a perfusion lumen communicating with a blood vessel, and a magnetically driven impeller disposed in the perfusion lumen to increase blood flow through the catheter and the arteries.
摘要翻译：具有与血管连通的灌注腔的气囊导管和设置在灌注腔内的磁驱动叶轮以增加通过导管和动脉的血流。

40. 发明授权

US6045576A Sewing ring having increased annular coaptation 失效
标题翻译：缝制环具有增加的环形接合
公开(公告)号：US6045576A
公开(公告)日：2000-04-04
申请号：US932818
申请日：1997-09-16
申请人： Albert Starr , Robert Stobie , Michael N. Helmus
发明人： Albert Starr , Robert Stobie , Michael N. Helmus
IPC分类号： A61F2/24
CPC分类号： A61F2/2409
摘要： A sewing ring for implantation of prosthetic heart valves has a compliant ring member made of a plurality of cells. The ring member may be silicon rubber and the cells defined within outer walls and inner ribs. A biocompatible fabric covering surrounds at least an outer portion of the ring member, and the assembly mounts to a mechanical or tissue-type prosthetic heart valve. The ring member has a radial dimension and cross-sectional area sufficient to ensure a large coaptation area between the sewing ring and the annulus tissue so as to enable adequate attachment of the valve without load distributing devices such as pledgets. A version of the sewing ring for attachment to the mitral annulus includes a curved coaptation edge, while another embodiment for attachment to the aortic annulus has a tapered outer edge with increased radial and axial dimensions. The sewing ring eliminates the need for pledgets, reduces the number of sutures required, lessens the potential for decubitous ulceration, and provides a better seal against perivalvular leakage. Moreover, the aortic valve sewing ring is sufficiently flexible and large to be able to be placed intra- or supra-annularly, as the surgeon deems best for the patient.
摘要翻译：用于植入假体心脏瓣膜的缝合环具有由多个细胞制成的顺应环构件。环形构件可以是硅橡胶，并且限定在外壁和内肋内的电池。生物相容性织物覆盖物围绕环构件的至少外部部分，并且该组件安装到机械或组织型假体心脏瓣膜。环形构件具有足以确保缝合环和环带组织之间的大的接合区域的径向尺寸和横截面面积，以便能够在没有负载分配装置（例如毛坯）的情况下充分地附接阀。用于连接到二尖瓣环的缝合环的形式包括弯曲的接合边缘，而用于附接到主动脉环的另一实施例具有增大的径向和轴向尺寸的锥形外边缘。缝合环消除了对毛刺的需要，减少了所需的缝合线数量，减少了褥疮性溃疡的可能性，并提供了更好的密封以防止周围的渗漏。此外，主动脉瓣缝合环具有足够的灵活性和大尺寸，以便能够被内置或超环形放置，因为外科医生认为对患者最好。

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