公开(公告)号：US20030105427A1

公开(公告)日：2003-06-05

申请号：US10010212

申请日：2001-12-04

Applicant: Advanced Cardiovascular Systems, Inc.

Inventor： Jeong S. Lee ,  Kenneth L. Wantink

IPC: A61M029/00

CPC classification number: A61M25/1036 ,  A61M2025/0034 ,  A61M2025/0037

Abstract: A catheter having a polymeric reinforcing member at a junction between shaft sections such as a rapid exchange catheter junction. The polymeric reinforcing member is around or within the tubular member defining the inflation lumen or the tubular member defining the guidewire lumen at the rapid exchange junction to prevent or inhibit damage to the tubular members defining the inflation lumen and/or guidewire lumen during assembly or use of a balloon catheter. In one embodiment, the polymeric reinforcing member is formed of a first polymeric material having a glass transition temperature greater than a glass transition temperature of a second polymeric material forming the distal portion of the proximal tubular member or the proximal portion of the inner tubular member. The first polymeric material forming the polymeric reinforcing member is preferably a high temperature, high modulus material, such as polyimide, and most preferably a thermoset polyimide.

Abstract translation: 导管，其具有在诸如快速交换导管接头的轴部分之间的接合处的聚合物加强构件。 聚合物加强构件在管状构件的周围或内部，限定膨胀腔或管状构件，其在快速交换结处限定导丝管腔，以防止或抑制在组装或使用期间限定充气腔和/或导丝腔的管状构件的损伤 的气球导管。 在一个实施例中，聚合物加强构件由玻璃化转变温度大于形成近端管状部件的远端部分或内部管状部件的近端部分的第二聚合物材料的玻璃化转变温度的第一聚合物材料形成。 形成聚合物增强部件的第一聚合物材料优选是高温高模量材料，例如聚酰亚胺，最优选热固性聚酰亚胺。

公开(公告)号：US20030055449A1

公开(公告)日：2003-03-20

申请号：US09957354

申请日：2001-09-19

Applicant: Advanced Cardiovascular Systems, Inc.

Inventor： Jeong S. Lee ,  Edwin Wang ,  Roseminda J. White ,  Jose A. Romero

IPC: A61M029/00

CPC classification number: A61F2/95 ,  A61B2090/3954 ,  A61L29/106 ,  A61L29/126 ,  A61L29/18 ,  A61M25/10 ,  A61M25/1029 ,  A61M25/104 ,  A61M2025/1031 ,  A61M2025/1075 ,  A61M2025/1079

Abstract: Medical devices or components thereof, and particularly intracorporeal devices for therapeutic or diagnostic uses, which are formed at least in part of a polymeric material and a ferromagnetic or paramagnetic material, so that the medical device or component thereof is visible on magnetic resonance imaging (MRI) scans. In one embodiment, the medical device is a balloon catheter having an MRI visible balloon. In a presently preferred embodiment, there is an insufficient amount of the ferromagnetic or paramagnetic material within a wall of the balloon or coated onto a wall of the balloon to make the balloon radiopaque.

Abstract translation: 医疗器械或其组件，特别是用于治疗或诊断用途的体内器件，其至少部分地由聚合物材料和铁磁性或顺磁性材料形成，使得医疗器械或其组件在磁共振成像（MRI） ）扫描。 在一个实施例中，医疗装置是具有MRI可见气囊的气囊导管。 在目前优选的实施方案中，在球囊的壁内存在不足量的铁磁性或顺磁性材料，或涂覆在气球的壁上，以使气球不透射线。

公开(公告)号：US20030055447A1

公开(公告)日：2003-03-20

申请号：US09957526

申请日：2001-09-19

Applicant: Advanced Cardiovascular systems, Inc.

Inventor： Jeong S. Lee ,  Edwin Wang ,  Roseminda J. White

IPC: A61M029/00

CPC classification number: A61M25/0045 ,  A61L29/085 ,  A61M25/0009 ,  A61M25/104 ,  C08L77/12 ,  C08L75/04 ,  C08L79/08

Abstract: A catheter having an multilayered shaft section with a first layer formed of a polyimide first material and a second layer formed of a second material. In a presently preferred embodiment, the polyimide material is a thermoset polyimide. However, in alternative embodiments, a thermoplastic polyimide is used. The thermoset polyimide has a very high glass transition temperature (Tg) of approximately 400null C. (as measured by differential scanning calorimetry), and excellent dimensional stability at the processing temperature of polyamides commonly used in catheter components. As a result, during formation and assembly of the catheter, production of a thin polyimide layer with controlled dimensions is facilitated. The polyimide has a high modulus and provides a thin walled yet highly pushable shaft section, while the second layer provides kink resistance. In one embodiment, the second material is selected from the group consisting of a polyamide material and a polyurethane material.

公开(公告)号：US20020018866A1

公开(公告)日：2002-02-14

申请号：US09899828

申请日：2001-07-05

Applicant: Advanced Cardiovascular Systems, Inc.

Inventor： Jeong S. Lee ,  Debashish Dutta

IPC: B65D001/00

CPC classification number: A61L29/06 ,  Y10T428/1386 ,  C08L77/00

Abstract: An inflatable member such as a balloon which is formed at least in part of a polyamide/polyether block copolymer thermoplastic elastomer, commonly referred to as polyether block amide (PEBA). The presently preferred PEBA copolymer is polyamide/polyether polyester copolymer, such as PEBAXnull. The balloon of the invention exhibits high tensile strength, high elongation, and low flexural moduli. The balloon may be formed as a single layer of PEBA, or as a multilayer coextrudate having at least one PEBA layer. The balloon may be 100% PEBA or a blend of PEBA with another polymer, such as nylon.

Abstract translation: 至少部分由聚酰胺/聚醚嵌段共聚物热塑性弹性体形成的可膨胀构件，例如气球，通常称为聚醚嵌段酰胺（PEBA）。 目前优选的PEBA共聚物是聚酰胺/聚醚聚酯共聚物，例如PEBAX。 本发明的气囊显示出高拉伸强度，高伸长率和低弯曲模量。 气囊可以形成为单层PEBA，或者形成为具有至少一个PEBA层的多层共挤出物。 球囊可以是100％PEBA或PEBA与另一种聚合物如尼龙的混合物。

公开(公告)号：US20030083616A1

公开(公告)日：2003-05-01

申请号：US10002933

申请日：2001-11-01

Applicant: Advanced Cardiovascular Systems, Inc.

Inventor： Jeong S. Lee ,  Kenneth L. Wantink

IPC: A61M029/00

CPC classification number: A61L2/087 ,  A61L2202/24 ,  A61M25/10

Abstract: A method of sterilizing a medical device component, such as a catheter balloon, in which an electron beam (i.e., e-beam) is applied to the component in an evacuated or inert gas-filled container. The method of the invention allows for electron beam sterilization without significant degradation of the component polymeric material. In one embodiment, the device component is configured to be pressurized or expanded during use. The method of the invention provides a component with a rupture pressure that is not significantly decreased due to electron beam sterilization. Another aspect of the invention is a medical device component, e-beam sterilized according to a method of the invention. A variety of medical device components can be sterilized by the method of the invention, and particularly intracorporeal devices for therapeutic or diagnostic purposes, such as balloon catheters, catheter shafts and balloons, stent covers, and vascular grafts.

Abstract translation: 对在真空或惰性气体填充的容器中的组件施加电子束（即电子束）的医疗装置部件（例如导管球囊）进行灭菌的方法。 本发明的方法允许电子束灭菌而不会显着降低组分聚合物材料。 在一个实施例中，装置部件构造成在使用期间被加压或膨胀。 本发明的方法提供了由于电子束灭菌而没有显着降低的断裂压力的部件。 本发明的另一方面是根据本发明的方法消毒的电子束的医疗装置部件。 可以通过本发明的方法，特别是用于治疗或诊断目的的体内器件，例如球囊导管，导管轴和球囊，支架盖和血管移植物来消毒各种医疗装置部件。

公开(公告)号：US20030055448A1

公开(公告)日：2003-03-20

申请号：US09957593

申请日：2001-09-19

Applicant: Advanced Cardiovascular systems, Inc.

Inventor： Jeong S. Lee ,  Edwin Wang

IPC: A61M029/00

CPC classification number: A61M25/10 ,  A61L29/085 ,  A61L2420/08 ,  A61M25/001 ,  A61M25/0045 ,  A61M25/0069 ,  A61M2025/1093 ,  C08L79/08 ,  C08L77/00 ,  C08L77/12 ,  C08L75/04

Abstract: A catheter having an elongated shaft which has a multilayered distal tip with a first layer formed of a polyimide first material and a second layer formed of a polymeric second material. In one embodiment the multilayered distal tip is a separate member, distal to the distal end of a proximal portion of the shaft. In another embodiment, the shaft has an outer tubular member, and a multilayered inner tubular member with a distal end which forms the multilayered distal tip of the shaft. In a presently preferred embodiment, the polyimide material is a thermoset polyimide. In one embodiment, the polymeric second material is a polyamide material.

Abstract translation: 一种具有细长轴的导管，该细长轴具有由聚酰亚胺第一材料形成的第一层和由聚合物第二材料形成的第二层的多层远端。 在一个实施例中，多层远侧末端是远离轴的近端部分的远端的分离的构件。 在另一个实施例中，轴具有外部管状构件和多层内部管状构件，其具有形成轴的多层远侧末端的远端。 在目前优选的实施方案中，聚酰亚胺材料是热固性聚酰亚胺。 在一个实施方案中，聚合物第二材料是聚酰胺材料。

公开(公告)号：US20020146557A1

公开(公告)日：2002-10-10

申请号：US09827887

申请日：2001-04-06

Applicant: Advanced Cardiovascular Systems, Inc.

Inventor： Charles D. Claude ,  Jeong S. Lee

IPC: B32B027/06

CPC classification number: C08J7/123 ,  A61L29/085 ,  A61L31/10 ,  A61M25/0009 ,  A61M25/0014 ,  A61M25/1027 ,  A61M25/1029 ,  A61M25/1034 ,  B05D1/62 ,  Y10S623/926 ,  Y10T428/26 ,  Y10T428/263 ,  Y10T428/265 ,  Y10T428/31504 ,  Y10T428/3154 ,  Y10T428/31544 ,  Y10T428/31551 ,  Y10T428/31663 ,  Y10T428/31721 ,  Y10T428/31855

Abstract: Medical devices, and particularly intracorporeal devices for therapeutic or diagnostic uses, having a component chemically modified by plasma polymerization. The medical device comprises a substrate with a plasma polymerized functionality bonded to a surface of at least a section thereof. The plasma polymerized film on a first component of the medical device allows for bonding an agent or a second component to the first component. In one embodiment, the plasma polymerized film facilitates fusion or adhesive bonding of a first component to a second component formed of a material which is dissimilar to, incompatible with, or otherwise not readily bondable to the substrate material of the first component. In another embodiment, a bioactive agent is bonded to the plasma polymerized film on the component, for presenting or delivering the bioactive agent within a body lumen of the patient.

Abstract translation: 医疗装置，特别是用于治疗或诊断用途的体内装置，其具有通过等离子体聚合化学改性的组分。 医疗装置包括具有等离子体聚合功能性的基底，其结合至少部分的表面。 医疗装置的第一部件上的等离子体聚合膜允许将试剂或第二组分粘合到第一组分。 在一个实施方案中，等离子体聚合膜促进第一组分与由与第一组分的衬底材料不相容，不相容或不容易粘合的材料形成的第二组分的熔融或粘合。 在另一个实施方案中，生物活性剂与组分上的等离子体聚合膜结合，用于在患者的体腔内呈递或递送生物活性剂。