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.
医疗设备 (
10
) 包括导管轴 (
11
) 包括内导管轴和外导管轴 (
12
和
14
)和一个可膨胀球囊(
18
)由导管轴 (
11
).球囊 (
18
) 由聚
酰胺弹性体和至少一种额外的交联反应物的辐照交联混合物制成。聚
酰胺弹性体可以是聚
酯酰胺、聚醚
酯酰胺或聚醚
酰胺,最好是尼龙嵌段共聚物。交联反应物可以是:(a) 二官能团材料,(b) 三官能团材料,(c) 四官能团材料,或 (d) 含有至少两个环状取代基的芳香族分子,每个环状取代基都在其中的一个
苄基位点上具有可变
氢。交联反应物也可以是
邻苯二甲酸二
烯丙酯或偏
苯二马来
酰亚胺。辐照是通过暴露于电子束或紫外线、X 射线或伽马射线中进行的,总通量最好在约 0.5 至约 20 兆拉德之间。选择交联反应物的量是为了避免在球囊(
18
交联剂的用量和辐照通量的选择是为了使气球的强度与单纯辐照得到的强度大致相等。