公开(公告)号：WO1997017099A1

公开(公告)日：1997-05-15

申请号：PCT/US1996017434

申请日：1996-10-29

Applicant: C.R. BARD, INC.

Inventor： C.R. BARD, INC. ,  ENGER, Christine, D.

IPC: A61M25/10

CPC classification number: A61M25/1002 ,  A61M2025/0057 ,  A61M2025/105

Abstract: A method, and an apparatus for use in practicing the method, are provided by which a highly concentrated medication or chemotherapeutic agent can be applied locally under sufficient pressure to cause the medication or agent to penetrate into localized tissue or a body lumen. The total volume of medication or agent is quite small, well below levels that might cause an adverse reaction in other parts of the body. The catheter includes a thin wall flexible balloon having two collars and a central region between the collars, when the central regions defines a plurality of regularly spaced minute perforations through which medication may weep at a controlled, low flow rate. The flow rate is controlled by the minute perforations and the diameter of the central region is less than the diameter of the collars. In practicing the method of the invention, the balloon is selected such that the inflated diameter of the collars will correspond to or be slightly greater than the diameter of lumen into which the balloon is placed, and the central region will be slightly less than that lumen diameter, thereby defining a distinct, annular medication reservoir between the balloon and body lumen. The depth of the reservoir reduces the risk of medicine jetting against the vessel lumen if excess pressure is applied. Inflation of the balloon with a medication will cause the medication to weep from the central region of the balloon, consequently filling the reservoir and bathing the lumen walls. After a predetermined time, a sufficient amount of medication will be absorbed by the lumen walls and the balloon will be deflated so that the catheter may be withdrawn from the lumen. The quantity of medication that ultimately flows into the vessel lumen is sufficiently small so as to not cause any other systemic damage to the patient.

Abstract translation: 提供了一种用于实施该方法的方法和装置，通过该方法和方法可以在足够的压力下局部施用高度浓缩的药物或化学治疗剂，以使药物或药剂渗入局部组织或体腔。 药物或药物的总体积相当小，远低于可能在身体其他部位引起不良反应的水平。 当中心区域限定多个规则间隔开的微小穿孔时，导管包括具有两个凸环的两个凸环和中心区域的薄壁柔性气囊，药物可以以受控的低流速在其中哭泣。 流量由微小穿孔控制，中心区域的直径小于套环的直径。 在实施本发明的方法中，气囊被选择成使得套环的膨胀直径将对应于或稍微大于放置气囊的管腔的直径，并且中心区域将稍微小于该内腔 直径，从而在球囊和体腔之间限定出不同的环形药物储存器。 如果施加过多的压力，储存器的深度会降低药物向血管腔内喷射的风险。 气囊与药物的充气将导致药物从气球的中心区域哭泣，从而填充储存器并洗澡腔壁。 在预定时间之后，足够量的药物将被腔壁吸收，并且气囊将被放气，使得导管可以从内腔中取出。 最终流入血管腔的药物的量足够小，以致不会对患者造成任何其它系统损伤。