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    • 2. 发明申请
    • Medical device including improved expandable balloon
    • 医疗装置包括改进的可膨胀气囊
    • US20040073164A1
    • 2004-04-15
    • US10463749
    • 2003-06-16
    • Cook IncorporatedSabin Corporation
    • Scott E. BoatmanDavid G. BurtonMichael C. HoffaDavid R. LessardDavid A. Drewes JR.Maggie A.Z. Hupcey
    • A61M029/00A61M031/00A61M037/00
    • C08G69/48A61L29/06C08F283/04C08L77/00C08F218/16
    • A medical device (10) includes a catheter shaft (11) including inner and outer catheter shafts (12 and 14), and an expandable balloon (18) carried by the catheter shaft (11). The balloon (18) is made from an irradiation cross-linked mixture of a polyamide elastomer and at least one additional cross-linking reactant. The polyamide elastomer can be a polyester amide, a polyether ester amide or a polyether amide, and is preferably a nylon block copolymer. The cross-linking reactant can be: (a) a difunctional material, (b) a trifunctional material, (c) a tetrafunctional material, or (d) an aromatic molecule containing at least two ring substituents, each of the ring substituents having labile hydrogens at a benzylic site therein. The cross-linking reactant can also be diallyl phthalate or meta-phenylene dimaleimide. Irradiation is carried out by exposure to an electron beam or to ultraviolet, X- or gamma radiation, preferably at a total fluence of about 0.5 to about 20 megarads. The amount of the cross-linking reactant is selected to avoid the formation of gelling during the process by which the balloon (18) is made, and the amount of the cross-linking agent and the irradiation fluence are selected to give the balloon a strength generally about equal to that which would be obtained by mere irradiation.
    • 医疗装置(10)包括导管轴(11),其包括内导管轴和外导管轴(12和14)和由导管轴(11)承载的可膨胀气囊(18)。 球囊(18)由聚酰胺弹性体和至少一种另外的交联反应物的照射交联混合物制成。 聚酰胺弹性体可以是聚酯酰胺,聚醚酯酰胺或聚醚酰胺,优选为尼龙嵌段共聚物。 交联反应物可以是:(a)双官能材料,(b)三官能材料,(c)四官能材料,或(d)含有至少两个环取代基的芳族分子,每个环取代基具有不稳定性 在其苄基位点处的氢。 交联反应物也可以是邻苯二甲酸二烯丙酯或间亚苯基二马来酰亚胺。 照射通过暴露于电子束或紫外线,X射线或γ射线进行,优选以约0.5至约20兆拉德的总注量。 选择交联反应物的量以避免在制备气囊(18)的过程中形成胶凝,并且选择交联剂的量和照射注量以使球囊具有强度 通常大约等于仅通过照射获得的能量。