Devices for extracting biliary or urinary stones

Details Devices for extracting biliary or urinary stones Devices for extracting biliary or urinary stones

2000-07-13

2004-02-17

Denion, Thomas (Department: 3748)

Surgery

Means or method for facilitating removal of non therapeutic...

Urinary catheter

C604S540000, C604S101010, C604S104000, C600S031000, C606S191000

Reexamination Certificate

active

06692484

ABSTRACT:

TECHNICAL FIELD
This invention relates generally to medical devices, and more particularly to devices for engaging and extracting or removing stones, calculi or the like from the biliary or urinary tracts.
BACKGROUND OF THE INVENTION
A variety of tracts or ducts in the body are subject to the development of stones, calculi or the like. (For convenience, such stones, calculi and the like may sometimes be referred to herein by the words “stone” or “stones”. For example, stones may develop in the kidneys and migrate down the ureters. Sometimes such stones become lodged in the ureters, requiring surgical intervention for their removal. Similarly, gallstones may develop in the gallbladder, and migrate down the biliary duct (the common bile duct), through the ampulla of Vater, and out the Sphincter of Oddi into the duodenum. As with kidney stones, such stones occasionally become lodged in the biliary duct, the pancreatic duct or the ampulla of Vater. Indeed, gallstones can be of such a size as to be unable to pass through the Sphincter of Oddi. In either case, surgical intervention is again required for their removal.
A number of surgical devices are known for engaging and extracting or removing stones from the biliary or urinary tracts. However, the satisfactory introduction of such devices into the ampulla of Vater or the associated ducts may require the surgical cutting of the papilla of Vater (in which the Sphincter of Oddi is formed). Such cutting is commonly performed with sphincterotomes, in particular, papillotomes. Such cutting devices are typically used in conjuction with an endoscope.
A very useful papillotome is disclosed in U.S. Pat. No. 5,024,617 (J. Karpiel, Jun. 18, 1991). The specification of the patent notes that a survey conducted by the American Society for Gastrointestinal Endoscopy revealed that the most common major complication from endoscopic sphincterotomy was bleeding. The specification of the patent further notes that the vast majority of such bleeding typically results when the retroduodenal artery is cut. Other major complications include pancreatitis, perforation and cholangitis. The device disclosed in the patent is intended to enhance the control a physician has while performing a sphincterotomy, and thereby reduce the risk of such injury to the patient from the procedure. While the device disclosed in the patent appears to achieve this desired reduction in risk, healing of the papilla of Vater after cutting can be problematic. Moreover, the physical arrangement of useful surgical cutters may hinder visualization of the site being cut. Further, U.S. Pat. No. 5,383,849 (F. Johlin, Jr., Jan. 24, 1995) notes that, when a cannula is used in endoscopic retrograde cholangiopancreatography (ERCP), difficulty is sometimes encountered in the attempt to successfully cannulate (that is, enter with a cannula) the desired duct among the bile and pancreatic ducts.
Attempts have been made to avoid the problems associated with cutting of the papilla of Vater. For example, catheter devices including inflatable balloons have been used to temporarily dilate the Sphincter of Oddi (or other biliary structure) so as to permit the passage of retrieval baskets or extraction balloons therethrough. One such biliary balloon dilator is sold by Wilson-Cook Medical Inc., Winston-Salem, N. C., under the name Quantum TTC®. That dilator includes a biliary dilation balloon carried on a dual-lumen catheter, one lumen serving for the introduction of an inflation medium into the dilation balloon, and the other lumen accepting a conventional 0.89 mm (0.035 in.) guide wire therein. An associated apparatus (the Quantum Biliary Inflation Device, or Q.B.I.D.™) is used to control the inflation pressure or inflation volume of the balloon.
During use, the deflated balloon of the device is first positioned via an endoscope across the structure to be dilated, for example, across the Sphincter of Oddi, and then inflated to dilate the structure. The balloon is then deflated and removed from the structure, and the device removed from the patient. It has been found that the Sphincter of Oddi remains dilated for a few minutes before it closes; during the time it is dilated, a retrieval basket or extraction balloon is introduced through the endoscope and through the dilated Sphincter, into engagement with the stones to be removed.
An example of an extraction balloon device useful for this purpose is the Tri-Ex™ Triple Lumen Extraction Balloon sold by Wilson-Cook Medical Inc. The device includes a triple lumen catheter which carries on it a distending latex balloon. One lumen serves to deliver an inflation medium to the balloon, a second serves to contain a conventional guide wire, and a third permits the introduction of a contrast medium distal (above) or proximal (below) the balloon. The volume of inflation medium is determined by a premeasured syringe connected to the first lumen. In use, the deflated balloon of the device is introduced through the Sphincter of Oddi (for example, via the endoscope) past the stones, then inflated and employed to urge the stones towards and out the Sphincter of Oddi. Other retrieval balloons are of course useful for this purpose as well.
A variety of retrieval baskets are known for the endoscopic removal of stones and other foreign bodies from both the biliary and urinary tracts. Such baskets can be exemplified by the WEB™ Extraction Basket sold by Wilson-Cook Medical Inc., which includes a plurality of filaments or wires constructed of a shape memory material. Nitinol in a superelastic state is an example of a shape memory material. As a further example, U.S. Pat. No. 4,295,464 (A. A. Shihata, Oct. 20, 1981) discloses a ureteric stone extractor having two ballooned catheters, in particular, an inner dislodger catheter slidable within a relatively larger outer dilator catheter. The dislodger catheter includes a lumen having a stiffening metal stylet disposed in it. The balloon of the dilator catheter must remain inflated during use of the extractor, thus preventing visualization of the stone by an endoscope.
Unfortunately, the successful use of many of such devices is often not possible. In particular, the closure time of the papilla of Vater (that is, the time in which the Sphincter of Oddi closes after dilation by the balloon) is so short that the Sphincter of Oddi often closes before the dilation balloon catheter is removed from the patient and the retrieval basket or extraction balloon is introduced and advanced to the Sphincter. Even when the guide wire has been advanced through the Sphincter, cannulation of the extraction balloon through the collapsed Sphincter may still be difficult. Moreover, guide wires are not generally used with retrieval baskets; unless the basket is introduced quickly enough, the dilation of the Sphincter is a wasted effort. Further, since the dilation balloon is typically axially aligned with the line-of-sight of the endoscope, ensuring that the balloon actually lies across the Sphincter of Oddi or other structure may be difficult as well.
It would be highly advantageous to have devices which permitted the engagement and extraction or removal of stones, calculi or the like from the biliary tract, the urinary tract or other body structure without requiring any surgical cutting of body tissue. It would also be highly advantageous to have devices which permitted the introduction of a retrieval basket, extraction balloon or the like quickly enough to take advantage of the time the Sphincter of Oddi or other structure remained dilated, so as to permit the ready passage of the basket or balloon through the Sphincter and allow the ready observation of the engagement of the stones by the basket or balloon via the endoscope. It would further be highly advantageous to have devices which permitted the basket, balloon or the like to urge the stones through the Sphincter of Oddi or other structure while it was still dilated. Finally, it would be highly advantageous to have dilation balloon devices which affirmatively ensured the position of the dilat

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