System and method for introducing a prosthesis

Abstract

A method and apparatus for introducing a first elongate medical device and short wire guide that are coupled together into a work site and remotely disconnecting them within the work site such that a secondary device comprising a catheter member can be introduced over the wire guide to the work site, and / or a second wire guide can be introduced to the work site via a passageway of the primary access device. A system of indicia, such as radiopaque or viewable markers, permits the operator to monitor the relative alignment of the devices within the work site to determine when uncoupling has occurred. In one example of the method, a wire guide and primary access device (e.g., a sphincterotome) is coupled to the wire guide and introduced via a duodenoscope into the biliary system. After performing a first medical operation, the devices are uncoupled with the wire guide being left within the biliary system such that a secondary access device, such as a balloon, biopsy device, stent delivery catheter, dilator, etc., can be introduced to perform a second medical operation without a traditional over-the-wire exchange being required. In another example of the method, a prosthesis, such as a valve or stent, is placed within the work site coupled to a wire guide which is remotely disconnected within the work site and a secondary device, such as a dilation balloon or second prosthesis, is introduced into the work site after the first delivery system is removed.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a non-provisional application which claims priority of provisional applications Ser. No. 60 / 491,408, filed Jul. 31, 2003, Ser. No. 60 / 563,968, filed Apr. 21, 2004, and Ser. No. 60 / 570,656, filed May 13, 2004.TECHNICAL FIELD [0002] This invention relates to medical devices, more particularly catheters and the like that are introduced into the patient over a wire guide. BACKGROUND OF THE INVENTION [0003] Minimally invasive medicine, the practice of gaining access into a blood vessel, duct, or organ using a wire guide to facilitate the subsequent introduction or placement of catheters and other medical devices, has been evolving since the Seldinger technique was first popularized during the late 1950s and 1960s. A significant advance was gaining the ability to exchange medical devices over a single indwelling wire guide without requiring displacement of the wire in the process and loss of access to the site. This ‘over ...

AI Technical Summary

Benefits of technology

This approach simplifies device exchange, reduces reliance on assistants, maintains wire guide access, and enhances procedural efficiency by allowing for longer wire use when needed, while minimizing complications such as air leakage and bacterial entry.

Problems solved by technology

Without the ability to receive such confirmation, it would be extremely difficult for the physician to attempt, with any confidence, the uncoupling of the catheter from the wire guide (e.g., under fluoroscopic guidance) without knowing when uncoupling has occurred or is about to occur.

Depending on the location or work site within the body and the device being delivered, an attempt to ‘blindly’ uncouple devices can lead to loss of wire guide access, especially if the device is prematurely withdrawn with the wire guide still engaged.

Furthermore, the amount of relative movement between the device and the wire guide required to ensure that uncoupling had occurred would generally be much greater than if indicia were utilized, thus increasing risks such as the wire guide being withdrawn too far and access lost or encountering situations where there is insufficient space within the work site left for uncoupling to take place.

Typical rapid exchange devices are not configured with the necessary radiographic or other appropriate indicia since the exchange procedure is intended to take place outside of the patient.

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