Surgery – Instruments – Electrical application
Reexamination Certificate
2001-05-09
2003-03-18
Jeffery, John A. (Department: 3742)
Surgery
Instruments
Electrical application
C604S164130, C604S528000
Reexamination Certificate
active
06533782
ABSTRACT:
TECHNICAL FIELD
This invention relates to medical devices, more particularly to catheters used in surgical procedures.
BACKGROUND OF THE INVENTION
Sphincterotomes are used in the biliary system as part of an Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure when the Sphincter of Oddi becomes constricted due to disease or trauma. The sphincterotome, which is typically introduced through the working channel of an endoscope, serves both to cannulate the ductal system and enlarge the opening by delivery of electrical current to a cutting wire. Most standard sphincterotome models, e.g., the MINI-TOME PC™ (Wilson Cook Medical, Inc., Winston-Salem, N.C.), include a wire guide side port connected distal to the handle into which a wire guide is introduced once access is obtained to the biliary system. The wire guide provides continual access across the sphincter as well as a means to exchange other devices that may be used. The wire guide port usually contains a luer fitting for injection of contrast media or other liquid materials. Unfortunately, this must be done with the wire guide removed so that the syringe or delivery apparatus can be coupled to the side port. Adding a separate fitting on the side port for the wire guide would create a portal for leakage of material, especially when contrast is being injected therethrough. To maintain separate injection and wire guide lumens, in addition to the required lumen for the electrical conductor wire, either results in either smaller lumens than would be optimal or necessary, or requires that the sphincterotome catheter be made larger, also something that is not desirable, especially for a device used within an endoscope. The same problem can be found in other devices, such as balloon catheters, and retrieval devices, such as baskets. Accommodating the control member of the apparatus, the wire guide, and still provide for the injection of contrast media, requires three separate pathways. Unfortunately, providing for all three to be simultaneously operable within a device is often unacceptable due to size constraints. What is needed is a medical device, such as a sphincterotome, that utilizes a control member, that can allow the wire guide to be used while the fluids (e.g., contrast media, saline) are being injected, without requiring a third lumen such that the device will pass through a standard endoscope.
SUMMARY OF THE INVENTION
The foregoing problems are also solved and a technical advance is achieved with a medical device, such as the illustrative sphincterotome, having a side port assembly which includes a first port, such as a standard luer lock fitting, which is adapted for injection of fluids or infusate (a first pathway), and a second port, such as a Tuohy-Borst fitting, that is configured for introduction of a standard medical wire guide (a second pathway) where the fitting on the second port can be made to seal around the wire guide to prevent the passage of air or fluids, while still permitting longitudinal movement of the wire guide. The first and second ports communicate with a first lumen of the catheter portion, such as via a shared first passageway (e.g., a cannula), while a second passageway lumen of the catheter portion contains the controlling element apparatus (e.g., electrical conductor (sphincterotome wire), actuating mechanism, inflation lumen(s), etc.) of the device (the third pathway), which may extend to the proximal handle of the device via a second passageway. Combining the fluid pathway and the wire guide pathway into a single passageway within the apparatus, permits the second pathway to be dedicated to housing the control apparatus. Otherwise, a third large lumen would have been required to accomodate all three pathways, thereby increasing the diameter of the catheter. By making the wire guide pathway (second port) sealable, such as with a Tuohy-Borst fitting, constrast media, saline, water, or other liquid media can be injected around the wire guide. For example, in the illustrative sphincterotome, the present invention allows a wire guide to be preloaded into the sphincterotome prior to the cannulation and cutting procedure, advantageously making the entire procedure easier and quicker to perform. In addition, having the preloaded wire guide extending from the distal tip, increases the physician's ability to cannulate closed sphincters and other strictures due to the smaller diameter of the wire guide. The same concept can be extended to other types of devices used with wire guides, such as balloons, catheters, baskets, snares, deflectable devices, etc., wherein the controlling element is disposed in the second passageway, while the wire guide and injected fluid share the first passageway.
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Carter Matthew P.
Foushee Jason D.
Gibbons, Jr. William S.
Howell Douglas A.
Agnew Charles W.
Jeffery John A.
Wilson-Cook Medical Incorporated
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