Provided is a medical device and production process thereof, which excels in the prevention of interfacial peeling between members abutting with each other in the radial direction, in addition to excellent flexibility. Such a medical device includes the tubular main body (210) of the catheter (200) which serves as the medical device, the inner layer (211) having the main lumen (220) therein, the coil layer (230) formed by winding the wire (231) of which traverse cross-sectional shape is non-circular, in the longitudinal direction, the outer layer (212), and the sub-lumen (280) containing the operation line (270) passing therethrough. The wire (231) of the coil layer (230), having the inner side (B) in the cross-sectional shape of the longitudinal cross-section of the catheter (200) being arc, and the maximum width direction of the cross-sectional shape inclining to the longitudinal direction, is wound so as to be fitted into both the inner layer (211) and the outer layer (212).本發明提供一種不僅可撓性優異、而且於徑方向上鄰接之構件間之界面剝離之防止效果亦優異的醫療機器、及醫療機器之製造方法。此種醫療機器包括如下而形成醫療機器即導管(200)之管狀本體(210):於內部具有主內腔(220)之內層(211)、由橫剖面形狀為非圓形之金屬絲(231)於長度方向上捲繞而形成之線圈層(230)、外層(212)、及供操作線(270)插通之子內腔(280)。線圈層(230)之金屬絲(231)於導管(200)之縱剖面之剖面形狀中其內側邊(B)為弧狀,該剖面形狀之最大寬度方向相對於長度方向傾斜,且以嵌入至內層(211)及外層(212)之方式捲繞。10‧‧‧管狀本體(細管)11、311‧‧‧內層12、312‧‧‧外層20‧‧‧主內腔30‧‧‧線圈層31‧‧‧金屬絲32‧‧‧捲繞間隙40‧‧‧標記物50‧‧‧塗層51‧‧‧樹脂材料70‧‧‧操作線70a‧‧‧第一操作線70b‧‧‧第二操作線71、71a、71b‧‧‧操作線之前端80‧‧‧子內腔80a‧‧‧第一子內腔80b‧‧‧第二子內腔100‧‧‧導管111‧‧‧樹脂材料(內層)112‧‧‧樹脂材料(外層)A‧‧‧外側邊B‧‧‧內側邊CE‧‧‧近位端DE‧‧‧遠位端
