Method of sterilizing a medical device

a technology of medical devices and balloons, applied in the field of balloon catheters, can solve the problems of reducing the trackability and crossability of the catheter in the patient's vasculature, affecting the patient's vasculature, and the polymer material sterilization is substantially degraded, so as to increase the wall thickness of the balloon, and avoid significant degradation of polymeric materials.

Inactive Publication Date: 2006-07-13
LEE JEONG S +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0013] The sterilization method of the invention avoids significant degradation of the polymeric material of the medical device component, as a result of sterilizing the medical device component in an evacuated or inert gas-filled container. Consequently, the method provides a sterilized medical device component such as a catheter balloon having a sufficiently high rupture pressure, without requiring an increase in the wall thickn

Problems solved by technology

Substantial, uncontrolled expansion of the balloon against the vessel wall can cause trauma to the vessel wall.
One difficulty has been sterilizing polymeric materials which degrade substantially in response to a conventional sterilization method.
Inc

Method used

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  • Method of sterilizing a medical device

Examples

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Embodiment Construction

[0020]FIG. 1 illustrates an over-the-wire type stent delivery balloon catheter 10 embodying features of the invention. Catheter 10 generally comprises an elongated catheter shaft 11 having a proximal end 12, a distal end 13, and an inflatable balloon 14 on a distal shaft section. An expandable stent 16 is mounted on balloon 14 for implanting in the patient's body lumen 18. In the embodiment illustrated in FIG. 1, the shaft 11 comprises an outer tubular member 19 and an inner tubular member 20. As best shown in FIGS. 2 and 3, illustrating transverse cross sections of the catheter 10 shown in FIG. 1, taken along lines 2-2 and 3-3, respectively, outer tubular member 19 defines an inflation lumen 21, and inner tubular member 20 disposed within the outer tubular member lumen 21 defines a guidewire lumen 22 configured to slidingly receive a guidewire 23. Inflatable balloon 14 is disposed on a distal section of catheter shaft 12, having a proximal end sealingly secured to the distal end of...

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Abstract

A method of sterilizing a medical device component, such as a catheter balloon, in which an electron beam (i.e., e-beam) is applied to the component in an evacuated or inert gas-filled container. The method of the invention allows for electron beam sterilization without significant degradation of the component polymeric material. In one embodiment, the device component is configured to be pressurized or expanded during use. The method of the invention provides a component with a rupture pressure that is not significantly decreased due to electron beam sterilization. Another aspect of the invention is a medical device component, e-beam sterilized according to a method of the invention. A variety of medical device components can be sterilized by the method of the invention, and particularly intracorporeal devices for therapeutic or diagnostic purposes, such as balloon catheters, catheter shafts and balloons, stent covers, and vascular grafts.

Description

BACKGROUND OF THE INVENTION [0001] This invention relates generally to medical devices, and particularly to balloon catheters, including angioplasty and stent delivery balloon catheters. [0002] In percutaneous transluminal coronary angioplasty (PTCA) procedures, a guiding catheter is advanced until the distal tip of the guiding catheter is seated in the ostium of a desired coronary artery. A guidewire, positioned within an inner lumen of a dilatation catheter, is first advanced out the distal end of the guiding catheter into the patient's coronary artery until the distal end of the guidewire crosses a lesion to be dilated. Then the dilatation catheter having an inflatable balloon on the distal portion thereof is advanced into the patient's coronary anatomy, over the previously introduced guidewire, until the balloon of the dilatation catheter is properly positioned across the lesion. Once properly positioned, the dilatation balloon is inflated with liquid one or more times to a pred...

Claims

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Application Information

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IPC IPC(8): A61L2/08A61F2/958
CPCA61L2/087A61L2202/24A61M25/10
Inventor LEE, JEONG S.WANTINK, KENNETH L.
Owner LEE JEONG S
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