公开(公告)号：US08647323B2

公开(公告)日：2014-02-11

申请号：US11967219

申请日：2007-12-30

申请人： Xiaoping Guo ,  David Johnson ,  Richard E. Stehr

发明人： Xiaoping Guo ,  David Johnson ,  Richard E. Stehr

IPC分类号： A61M25/00 ,  B28B5/00

CPC分类号： A61M25/0012 ,  A61M25/0043 ,  A61M25/005

摘要： A catheter shaft includes an inner layer of a first polymeric material, an intermediate layer of a second polymeric material, an outer layer of a third polymeric material, a first wire reinforcing layer encapsulated between the inner and intermediate layers, and a second wire reinforcing layer encapsulated between the outer and intermediate layers. Typically, the first wire reinforcing layer includes one or more metallic wires helically wound in one direction and the second wire reinforcing layer includes one or more metallic wires helically wound in the opposite direction. The intermediate layer is bonded to the inner and outer layers, as by extruding layers over one another or by thermal lamination or reflow bonding. Typically, the intermediate layer has a larger yield strain and/or a lower flexural modulus and/or a lower durometer than at least one of the inner layer and the outer layer.

摘要翻译： 导管轴包括第一聚合物材料的内层，第二聚合物材料的中间层，第三聚合物材料的外层，密封在内层和中间层之间的第一丝线增强层，以及第二丝线增强层 封装在外层和中层之间。 通常，第一线加强层包括沿一个方向螺旋缠绕的一个或多个金属线，第二线加强层包括沿相反方向螺旋缠绕的一根或多根金属线。 中间层通过彼此挤压层或通过热层压或回流焊接而结合到内层和外层。 通常，中间层具有比内层和外层中的至少一个更大的屈服应变和/或较低的弯曲模量和/或较低的硬度。

公开(公告)号：US08431057B2

公开(公告)日：2013-04-30

申请号：US11967220

申请日：2007-12-30

申请人： Xiaoping Guo ,  Richard E. Stehr

发明人： Xiaoping Guo ,  Richard E. Stehr

IPC分类号： D01D5/24

CPC分类号： A61M25/005 ,  A61M25/0009 ,  A61M25/0012 ,  A61M25/0043 ,  A61M25/0045 ,  A61M25/0108 ,  A61M2025/0059 ,  A61M2205/32 ,  B29C47/021 ,  B29C61/006 ,  B29C63/0069 ,  B29D23/001 ,  B29K2027/18 ,  B29K2105/16 ,  B29L2031/7542

摘要： A method of manufacturing a catheter shaft includes the steps of forming an inner layer of a first polymeric material, forming a plait matrix layer including a second polymeric material about the inner layer, and forming an outer layer of a third polymeric material about the plait matrix layer. The plait matrix layer includes a braided wire mesh partially or fully embedded within the second polymeric material, which is different from at least one of the first polymeric material forming the inner layer and the third polymeric material forming the outer layer. The second polymeric material has a higher yield strain and/or a lower hardness than at least the first polymeric material, and preferably both the first and the third polymeric materials. The first polymeric material and the third polymeric material may be different or the same. The catheter shaft may be formed by stepwise extrusion, co-extrusion, and/or reflow processes.

摘要翻译： 一种制造导管轴的方法包括以下步骤：形成第一聚合物材料的内层，形成围绕内层的包含第二聚合材料的辫子基质层，以及围绕辫状基体形成第三聚合物材料的外层 层。 辫状基质层包括部分或完全嵌入第二聚合物材料内的编织网，其不同于形成内层的第一聚合物材料和形成外层的第三聚合物材料中的至少一种。 第二聚合物材料具有比至少第一聚合物材料更高的屈服应变和/或更低的硬度，优选第一和第三聚合物材料。 第一聚合物材料和第三聚合物材料可以是不同的或相同的。 导管轴可以通过逐步挤出，共挤出和/或回流工艺形成。

公开(公告)号：US20100168270A1

公开(公告)日：2010-07-01

申请号：US12347217

申请日：2008-12-31

申请人： Xiaoping Guo ,  David P. Johnson ,  Richard E. Stehr

发明人： Xiaoping Guo ,  David P. Johnson ,  Richard E. Stehr

IPC分类号： A61F2/06

CPC分类号： C08L69/00 ,  C08G69/40 ,  C08K5/353 ,  C08L33/10 ,  C08L77/02 ,  C08L77/06 ,  C08L77/10 ,  C08L2666/20

摘要： The invention relates to biocompatible polycarbonate/polyamide polymer compositions for use in medical and surgical devices. Additional additives, crosslinking agents, phosphites, and optionally a radiopaque filler or fillers can be used to produce the high performance compositions desired. The polymer compositions have improved melt processability along with balanced or enhanced physical and mechanical properties, especially when combined or over-extruded onto or covering other polymer layers, such as soft and/or flexible layers commonly used in medical device applications and catheter tips, for example. The ability to incorporate radiopaque compounds into these polymer compositions during melt processing offers improved methods for monitoring and visualizing medical devices when used inside the body and as well as improving the operating characteristics of the medical device components

摘要翻译： 本发明涉及用于医疗和外科装置的生物相容性聚碳酸酯/聚酰胺聚合物组合物。 可以使用额外的添加剂，交联剂，亚磷酸酯和任选的不透射线填料或填料来生产所需的高性能组合物。 聚合物组合物具有改善的熔融加工性以及平衡或增强的物理和机械性能，特别是当组合或过度挤出到或覆盖其它聚合物层（例如通常用于医疗装置应用和导管尖端中的软和/或柔性层）时，其可用于 例。 在熔融加工过程中将不透射线化合物掺入这些聚合物组合物中的能力提供了改进的用于在身体内部使用时监测和可视化医疗装置的方法，以及改善医疗装置部件的操作特性

公开(公告)号：US20080208128A1

公开(公告)日：2008-08-28

申请号：US11911190

申请日：2006-04-28

申请人： Xiaoping Guo ,  Richard E. Stehr ,  Vitaliy G. Epshteyn ,  Bruce P. Holman ,  Donald A. Sauter ,  Chad A. Thorstenson ,  Daniel J. Potter ,  Nalin S. Perera

发明人： Xiaoping Guo ,  Richard E. Stehr ,  Vitaliy G. Epshteyn ,  Bruce P. Holman ,  Donald A. Sauter ,  Chad A. Thorstenson ,  Daniel J. Potter ,  Nalin S. Perera

IPC分类号： A61M25/00

CPC分类号： A61M25/001 ,  A61M25/0668 ,  A61M2025/0687 ,  Y10T29/49826

摘要： A splittable/peelable tubular body (2) of a catheter or sheath wherein the tubular body (2) has a splittable/peelable atraumatic tip (14) is disclosed. The atraumatic tip (4) is generally softer than the tubular body (2). The tubular body (2) and atraumatic tip (4) each comprise a peel mechanism longitudinally extending along their respective lengths. The peel mechanisms are formed by longitudinally extending regions of interfacial bonding (11) between first and second longitudinally extending strips (8, 10) of polymer material. Each strip (8, 10) forms at least a portion of an outer circumferential surface of the tubular body (2) and atraumatic tip (4). A region of stress concentration extends along the region of interfacial bonding. The stress concentration facilitates the splitting of the tubular body (2) and atraumatic tip (4) along their respective peel mechanisms.

摘要翻译： 公开了一种导管或护套的可分离/可剥离的管状体（2），其中管状体（2）具有可分离/可剥离的无创伤尖端（14）。 无创尖端（4）通常比管状体（2）更软。 管体（2）和无创尖端（4）各自包括沿其相应长度纵向延伸的剥离机构。 剥离机构由在聚合物材料的第一和第二纵向延伸的条带（8,10）之间的纵向延伸的界面结合区域（11）形成。 每个条带（8,10）形成管状体（2）和无创尖端（4）的外周表面的至少一部分。 应力集中区域沿界面粘合区域延伸。 应力集中有利于管状体（2）和无创尖端（4）沿其各自的剥离机构分裂。

公开(公告)号：US08657789B2

公开(公告)日：2014-02-25

申请号：US11911190

申请日：2006-04-28

申请人： Xiaoping Guo ,  Richard E. Stehr ,  Vitaliy G. Epshteyn ,  Bruce P. Holman ,  Donald A. Sauter ,  Chad A. Thorstenson ,  Daniel J. Potter ,  Nalin S. Perera

发明人： Xiaoping Guo ,  Richard E. Stehr ,  Vitaliy G. Epshteyn ,  Bruce P. Holman ,  Donald A. Sauter ,  Chad A. Thorstenson ,  Daniel J. Potter ,  Nalin S. Perera

IPC分类号： A61M5/178 ,  A61M25/098

CPC分类号： A61M25/001 ,  A61M25/0668 ,  A61M2025/0687 ,  Y10T29/49826

摘要： A splittable/peelable tubular body (2) of a catheter or sheath wherein the tubular body (2) has a splittable/peelable atraumatic tip (14) is disclosed. The atraumatic tip (4) is generally softer than the tubular body (2). The tubular body (2) and atraumatic tip (4) each comprise a peel mechanism longitudinally extending along their respective lengths. The peel mechanisms are formed by longitudinally extending regions of interfacial bonding (11) between first and second longitudinally extending strips (8, 10) of polymer material. Each strip (8, 10) forms at least a portion of an outer circumferential surface of the tubular body (2) and atraumatic tip (4). A region of stress concentration extends along the region of interfacial bonding. The stress concentration facilitates the splitting of the tubular body (2) and atraumatic tip (4) along their respective peel mechanisms.

摘要翻译： 公开了一种导管或护套的可分离/可剥离的管状体（2），其中管状体（2）具有可分离/可剥离的无创伤尖端（14）。 无创尖端（4）通常比管状体（2）更软。 管体（2）和无创尖端（4）各自包括沿其相应长度纵向延伸的剥离机构。 剥离机构由在聚合物材料的第一和第二纵向延伸的条带（8,10）之间的纵向延伸的界面结合区域（11）形成。 每个条带（8,10）形成管状体（2）和无创尖端（4）的外周表面的至少一部分。 应力集中区域沿界面粘合区域延伸。 应力集中有利于管状体（2）和无创尖端（4）沿其各自的剥离机构分裂。

公开(公告)号：US09352116B2

公开(公告)日：2016-05-31

申请号：US13795647

申请日：2013-03-12

申请人： Xiaoping Guo ,  Richard E. Stehr

发明人： Xiaoping Guo ,  Richard E. Stehr

IPC分类号： A61M25/00 ,  B29C61/00 ,  B29D23/00 ,  A61M25/01 ,  B29L31/00

CPC分类号： A61M25/005 ,  A61M25/0009 ,  A61M25/0012 ,  A61M25/0043 ,  A61M25/0045 ,  A61M25/0108 ,  A61M2025/0059 ,  A61M2205/32 ,  B29C47/021 ,  B29C61/006 ,  B29C63/0069 ,  B29D23/001 ,  B29K2027/18 ,  B29K2105/16 ,  B29L2031/7542

摘要： A method of manufacturing a catheter shaft includes the steps of forming an inner layer of a first polymeric material, forming a plait matrix layer including a second polymeric material about the inner layer, and forming an outer layer of a third polymeric material about the plait matrix layer. The plait matrix layer includes a braided wire mesh partially or fully embedded within the second polymeric material, which is different from at least one of the first polymeric material forming the inner layer and the third polymeric material forming the outer layer. The second polymeric material has a higher yield strain and/or a lower hardness than at least the first polymeric material, and preferably both the first and the third polymeric materials. The first polymeric material and the third polymeric material may be different or the same. The catheter shaft may be formed by stepwise extrusion, co-extrusion, and/or reflow processes.

公开(公告)号：US08728055B2

公开(公告)日：2014-05-20

申请号：US11910503

申请日：2006-06-14

申请人： Richard E. Stehr ,  Xiaoping Guo

发明人： Richard E. Stehr ,  Xiaoping Guo

IPC分类号： A61M25/00 ,  A61M25/06 ,  A61M25/01

CPC分类号： A61M25/005 ,  A61M25/0668 ,  A61M2025/0188

摘要： The present invention is a splitable/peelable reinforced flexible tubular body (10) for a catheter or sheath (12). The body (10) comprises a proximal end (14), a distal end (16), a wall structure (18), and a lumen (20) defined by the wall structure (18). The wall structure (18) extends between the ends and includes a reinforcement layer (22) within the wall structure (18) and a separation line (26) extending longitudinally along the wall structure (18). The separation line (26) is adapted to facilitate the splitting/peeling of the wall structure (18) to allow a medical device such as a pacemaker lead to be removed from within the tubular body (10).

摘要翻译： 本发明是一种用于导管或护套（12）的可分离/可剥离的增强柔性管状体（10）。 主体（10）包括近端（14），远端（16），壁结构（18）和由壁结构（18）限定的内腔（20）。 壁结构（18）在端部之间延伸并且包括壁结构（18）内的加强层（22）和沿着壁结构（18）纵向延伸的分离线（26）。 分离线（26）适于促进壁结构（18）的分裂/剥离，以允许诸如起搏器引线的医疗装置从管状体（10）内被移除。

公开(公告)号：US08273285B2

公开(公告)日：2012-09-25

申请号：US11033098

申请日：2005-01-10

申请人： Eric John Wilkowske ,  Allan Manuel Fuentes ,  Xiaoping Guo ,  Xuan Yen Khieu ,  Linda Kay Nemec ,  Richard E. Stehr

发明人： Eric John Wilkowske ,  Allan Manuel Fuentes ,  Xiaoping Guo ,  Xuan Yen Khieu ,  Linda Kay Nemec ,  Richard E. Stehr

IPC分类号： B29C43/00

CPC分类号： B29D23/00 ,  A61M25/0012 ,  A61M25/0045 ,  A61M25/005 ,  A61M25/0147

摘要： The present invention is a method of manufacturing a flexible tubular body for catheter, sheath or similar medical device. The method comprises pre-extruding an inner layer of the body from a thermoplastic polymer and then pulling the inner layer over a mandrel and tightening the layer down. If wire lumens were not integrally formed in the inner layer when pre-extruded, then two polymer spaghetti tubes, each with wire lumens, are laid 180 degrees apart axially along the outer surface of the inner layer. Deflection wires are then fed into the wire lumens. A cylindrical wire braid is woven or pulled over the inner layer (and the spaghetti tubes, as the case may be) and tightened down. The aforementioned components are then encased in an outer polymer layer. A heat-shrinkable tube is then placed over the outer layer. A pressurized fluid is injected into each wire lumen to maintain the internal diameter of each wire lumen at a diameter that is greater than the diameter of the deflection wire received in each wire lumen. Heat is then applied to the body and heat-shrinkable tube to cause the layers to laminate together. Once the newly laminated body has sufficiently cooled, the heat-shrinkable tube is removed from the body.

摘要翻译： 本发明是制造用于导管，鞘或类似医疗装置的柔性管体的方法。 该方法包括从热塑性聚合物预挤出主体的内层，然后将内层在心轴上拉动并将层紧固。 如果在预挤出时线内部未整体地形成在内层中，则将两根具有线腔的聚合物意大利面条沿着内层的外表面轴向地分开180度。 然后将变形线送入线腔内。 圆柱形编织物被编织或拉过内层（和意大利面条管，视情况而定）并收紧。 然后将上述组分封装在外聚合物层中。 然后将热收缩管放置在外层上。 加压流体被注入到每个线腔中，以将每个线腔的内径保持在大于每个线腔内接收的偏转线的直径的直径。 然后将热量施加到身体和热收缩管，以使层压在一起。 一旦新层压体已经充分冷却，热收缩管就从体内去除。

公开(公告)号：US20090166913A1

公开(公告)日：2009-07-02

申请号：US11967220

申请日：2007-12-30

申请人： Xiaoping Guo ,  Richard E. Stehr

发明人： Xiaoping Guo ,  Richard E. Stehr

IPC分类号： B29C63/06 ,  A61M25/16

CPC分类号： A61M25/005 ,  A61M25/0009 ,  A61M25/0012 ,  A61M25/0043 ,  A61M25/0045 ,  A61M25/0108 ,  A61M2025/0059 ,  A61M2205/32 ,  B29C47/021 ,  B29C61/006 ,  B29C63/0069 ,  B29D23/001 ,  B29K2027/18 ,  B29K2105/16 ,  B29L2031/7542

摘要： A method of manufacturing a catheter shaft includes the steps of forming an inner layer of a first polymeric material, forming a plait matrix layer including a second polymeric material about the inner layer, and forming an outer layer of a third polymeric material about the plait matrix layer. The plait matrix layer includes a braided wire mesh partially or fully embedded within the second polymeric material, which is different from at least one of the first polymeric material forming the inner layer and the third polymeric material forming the outer layer. The second polymeric material has a higher yield strain and/or a lower hardness than at least the first polymeric material, and preferably both the first and the third polymeric materials. The first polymeric material and the third polymeric material may be different or the same. The catheter shaft may be formed by stepwise extrusion, co-extrusion, and/or reflow processes.

摘要翻译： 一种制造导管轴的方法包括以下步骤：形成第一聚合物材料的内层，形成围绕内层的包含第二聚合材料的辫状基质层，以及围绕辫状基体形成第三聚合物材料的外层 层。 辫状基质层包括部分或完全嵌入第二聚合物材料内的编织网，其不同于形成内层的第一聚合物材料和形成外层的第三聚合物材料中的至少一种。 第二聚合物材料具有比至少第一聚合物材料更高的屈服应变和/或更低的硬度，优选第一和第三聚合物材料。 第一聚合物材料和第三聚合物材料可以是不同的或相同的。 导管轴可以通过逐步挤出，共挤出和/或回流工艺形成。

公开(公告)号：US20090171348A1

公开(公告)日：2009-07-02

申请号：US11966550

申请日：2007-12-28

申请人： Xiaoping Guo ,  Troy T. Tegg ,  Richard E. Stehr

发明人： Xiaoping Guo ,  Troy T. Tegg ,  Richard E. Stehr

IPC分类号： A61M25/092 ,  A61M25/00 ,  A61B18/18

CPC分类号： A61M25/0147 ,  A61B5/042 ,  A61B18/1492 ,  A61B2017/003 ,  A61M25/0052 ,  A61M25/0144

摘要： A guidable, or steerable, or deflectable catheter is provided that includes a proximal portion and a distal portion for insertion into a body cavity. A selectively deflectable segment having an anisotropic bending stiffness for deflection in individual planes is incorporated into the distal portion of the catheter shaft. Upon actuation of pull wires, the distal deflectable segment may be deflected to move/sweep the distal catheter tip through a sweeping plane. The anisotropic bending stiffness of the distal deflectable segment permits in-plane movement of the distal catheter tip in the sweeping plane while resisting any out-of-plane movements. In one arrangement, stiffening elements are selectively disposed within the distal deflectable segment such that the out-of-plane bending stiffness is largely increased and greater than the in-plane bending stiffness for deflection in the sweeping plane. In another arrangement, the cross section of a distal deflectable segment is altered to produce anisotropic area inertias of moment about its centroidal axes, and thus anisotropic bending stiffnesses.

摘要翻译： 提供可引导或可导向或可偏转的导管，其包括用于插入体腔的近端部分和远端部分。 具有针对各个平面中的偏转的各向异性弯曲刚度的选择性偏转段被并入导管轴的远端部分。 在牵引线的致动时，远端可偏转段可能被偏转以使远端导管尖端移动/扫掠通过扫掠平面。 远端可偏转段的各向异性弯曲刚度允许远侧导管尖端在扫掠平面内的平面内运动，同时抵抗任何平面外运动。 在一种布置中，加强元件选择性地设置在远侧可偏转节段内，使得面外弯曲刚度大大增加并且大于在扫掠平面中偏转的面内弯曲刚度。 在另一种布置中，改变远侧可偏转节段的横截面以产生围绕其重心轴线的力矩的各向异性面积惯性，从而产生各向异性弯曲刚度。