主权项 |
1. A balloon catheter system for insertion into a patient, using a guidewire previously inserted into a cavity of the patient, the system comprising:
a balloon catheter comprised of a tube having a first end, a second end opposite of the first end, a central bore fluidically coupling an inlet at the first end of the tube with an outlet at the second end of the tube and a lumen fluidically coupling a connector disposed adjacent the first end of the tube with a balloon disposed adjacent to the second end of the tube, the balloon being formed by a tubular film sealed at opposite ends of the tubular film to an external surface of the tube, the lumen having a lumen outlet such that fluid injected into the connector and through the lumen exits through the external surface of the tube at the lumen outlet and into an expandable cavity between the balloon, which is made of a flexible, resilient material, and the external surface of the tube, whereby the balloon is capable of being expanded by injecting fluid into the expandable cavity through the lumen; a detachable dilator, comprised of a sheath portion extending from a solid body, the solid body having a central bore passing through the solid body such that an annular shaft passing through the central bore of the tube of the balloon catheter and the central bore of the solid body removably retains the detachable dilator on the annular shaft at the second end of the tube, and the sheath portion extends seamlessly from a portion of the solid body having a first diameter, the first diameter being sized to an outer diameter of the tube such that the sheath portion extends over the outer diameter of the tube, and the solid body has a tip distal from the portion of the solid body having a first diameter, the tip having a second diameter, and the solid body having a transition region having an external diameter decreasing over a length of the transition region from the second diameter, larger than the first diameter, to the first diameter at the tip of the detachable dilator, the first diameter at the tip being substantially the same as an outer diameter of the annular shaft, and the annular shaft having an inner diameter greater than the diameter of the guidewire, such that the guidewire is insertable into the inner diameter of the annular shaft, and the annular shaft is guidable over the guidewire, the detachable dilator extending into the cavity of the patient as the annular shaft is guided over the guidewire, the detachable dilator being slidably engaged on the annular shaft, such that, when the annular shaft is withdrawn from the central bore of the tube, an inner surface of the central bore of the solid body slides over an external surface of the annular shaft, releasing the detachable dilator to detach from the annular shaft when the annular shaft is withdrawn from the tube, after inserting the tube into the cavity of the patient. |