1. Field of the Invention
The present invention relates generally to the structure and use of surgical instruments. More particularly, the present invention relates to a device and method for introducing a fluid, such as contrast medium, to a body duct, such as the cystic duct.
Cholangiography is a procedure for the X-ray of a patient's bile duct which is commonly performed to locate duct stones during surgical gallbladder removal. The presence of gallstones in the biliary ducts, particularly the common bile duct, is a painful and potentially fatal condition which exists in a significant percentage of patients who have undergone gallbladder removal. Surgical exploration of the common bile duct, however, is itself a relatively risky procedure which is associated with significant morbidity. Thus, the ability to locate the presence of gallstones by cholangiography is of significant benefit to the patient.
Surgical gallbladder removal, referred to as cholecystectomy, is most commonly performed as an open surgical procedure through a major incision in the patient's abdomen. After the gallbladder is removed, and the cystic duct ligated, a flexible catheter is introduced through a small incision in either the cystic duct or the common bile duct. A suitable contrast medium may then be introduced through the catheter to permit X-ray detection of any gallstones which may be present in the ducts.
Cholecystectomy and cholangiography are being performed with increasing frequency using laparoscopic surgical techniques. Laparoscopic surgery is performed through small incisions in the patient's abdomen allowing the necessary surgical instruments to be introduced through a tube, such as a cannula, while the physician observes manipulation of the instruments through a laparoscope. Such laparoscopic surgery offers significant advantages over conventional "open" cholecystectomy and cholangiography. In particular, the laparoscopic technique is usually less traumatic, requires a shorter recovery time, and is significantly less costly than the corresponding open surgical procedure.
The performance of laparoscopic cholangiography is not without its problems, however. A significant drawback is the need to position a cannula as an accessway through the abdominal wall for every instrument to be used during the procedure. The use of a large number of cannulas inflicts an undesirable degree of trauma on the patient. Further, it may be difficult to accurately predict the locations in the abdomen which will provide the most convenient points of access to the surgical site. If a cannula is positioned at an inconvenient location, it must be removed and repositioned, or an additional cannula must be inserted at the desired location, increasing traumatic impact. Trauma is worsened by the size of the cannulas used in laparoscopic procedures. Known cannulas tend to have an undesirably large diameter due to the need to provide a sealed access port of sufficient diameter to accommodate the laparoscopic instruments used in cholecystectomy and/or cholangiography procedure. Moreover, known cannulas require the use of specialized introduction instruments, such as needles or obturators, for percutaneous insertion through the abdominal wall.
For these reasons, it would be desirable to provide improved devices and methods to facilitate the introduction of fluids, such as contrast media, to body ducts, such as the biliary ducts. It would be particularly desirable to provide instruments for performing cholangiography using laparoscopic and other "least invasive surgical" procedures which would reduce the number of cannulas needed for access to the surgical site. Most desirably, the instruments should be self-introducing, without requiring the use of separate needles, obturators or other introduction instruments, and should not need cannulas or other such devices for percutaneous access to the surgical site. The devices should have a small cross-section section to minimize traumatic impact. The device and method should further allow infusion of fluid in a single direction within a duct, and prevent fluid flow in undesired directions in the duct or leakage out of the duct.
2. Description of the Background Art
Catheters and cannulas for introducing contrast media to a patient's bile ducts following open surgical gall bladder removal are described in the patent and medical literature. See, for example, U.S. Pat. Nos. 4,747,823; 4,547,187; 4,306,566; 4,044,757; 4,044,7581; and 3,918,456. Devices for clamping the cystic duct in conjunction with the open surgical introduction of a cholangiogram catheter are described in U.S. Pat. Nos. 4,817,604 and 4,792,330.