Surgery – Endoscope – With guide means for body insertion
Reexamination Certificate
2000-03-24
2002-08-27
Dvorak, Linda C. M. (Department: 3739)
Surgery
Endoscope
With guide means for body insertion
C600S115000, C604S043000, C604S264000, C606S108000
Reexamination Certificate
active
06440061
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to medical equipment and more particularly to laparoscopic surgical instruments of the type used in biliary tract procedures. The surgical instruments described herein facilitate common bile duct exploration and the removal of physiologic calculi, generally referred to as stones. The invention provides enhancements related to systematic insertion, deployment and manipulation of various instruments including a choledochoscope for concurrent real-time viewing of the laparoscopic surgical process.
BACKGROUND OF THE INVENTION
Many patients develop stones within their gall bladder, which may pass through the cystic duct to become lodged in the common bile duct, a condition known as choledocholithiasis. Stones are typically variable in size from 1.00-20.00 mm. These stones may block the common bile duct, the hepatic duct or intrahepatic ducts, and if untreated may result in obstructive jaundice that may result in cholangitis (infection within the biliary tract) and severe discomfort to the patient, or death due to sepsis or liver dysfunction. Solitary or multiple stones may be loose within the common bile duct or otherwise embedded into the common bile duct wall, or impacted at the Papilla of Vater. This condition typically requires concurrent surgical removal of the gall bladder along with removal of the stones from the common bile duct. This surgical procedure is referred to as cholecystectomy with common bile duct exploration.
The presence of stones in a patient's biliary tract is confirmed using typical diagnostic methods, such as cystic duct cholangiography or ultrasonography. Stones are also often discovered during laparoscopic cholecystectomy, a procedure for removal of the gall bladder. Common bile duct stones may also be anticipated preoperatively due to physical symptoms including jaundice, or from blood tests that indicates liver function abnormality. This condition is typically confirmed intraoperatively during cholecystectomy with cholangiography or by ultrasound.
Stone removal is conventionally attempted by various invasive surgical procedures for common bile duct exploration and stone removal, including; 1) open common bile duct exploration, 2) an endoscopic surgery known as endoscopic retrograde cholangio-pancreatography (ERCP), and 3) laparoscopic common bile duct exploration. Open surgery typically requires a substantially more invasive surgical incision with associated pain, increased length of hospitalization and prolonged recovery period, as compared to typical laparoscopic procedures.
Alternately, the ERCP procedure is limited to only the most skilled endoscopist. An additional specialist is required to perform this procedure. ERCP may not be effective and often further delays definitive treatment of the condition. ERCP is also associated with an increased risk of harm and even death due to pancreatitis.
Laparoscopic common bile duct exploration is typically the most desirable procedure for stone removal. This method of stone removal is often difficult and tenuous in performance due to various limitations in instrumentation, and as a result of the unique difficulties encountered by the surgeon in each operative procedure.
An array of laparoscopic surgical instruments are used for common bile duct exploration and stone retrieval, including balloon catheters, irrigation catheters, stone baskets, biopsy forceps, papillatome (to cut the Papillae of Vater), and lithotripter or fiber laser (to pulverize the calculi). These instruments and fiber-optic choledochoscope for viewing are passed through laparoscopic ports during the surgical procedure. Grasping forceps, which are inserted into the abdominal region via separate port incisions, are simultaneously deployed to position the various tools and choledochoscope.
Choledochoscopes include an array of fiber optic channels for light and image transmission, and a cable system that allows the surgeon to maneuver the distal tip of the instrument for viewing purposes. Choledochoscopes typically include a working channel for irrigation fluid or for deployment of various instruments such as basket, balloon or lithotripter instruments. These instruments are size-restricted (less than 3.0 mm) as a function of the working channel's relatively small diameter. Visualization within the bile duct is impaired as a result of restricted fluid flow when the working channel is occupied by a tool, and as a result of ineffective hydraulic distension of the bile duct. Said visual impairment results from an obstructive murk comprised of bile, blood and stone debris. A larger diameter (4-8 mm) choledochoscopes may be used to overcome the aforementioned limitations via the advantage of a larger working channel. The larger choledochoscopes are less fragile in comparison to the smaller diameter choledochoscopes, which are easily damaged by manipulation with grasping forceps. However, there is a disadvantage to using larger diameter scopes as they typically will not traverse the smaller regions of the biliary tree, or the papillae of Vader. In addition, many patients are characterized by common bile ducts of a relatively small diameter, thus precluding use of the larger diameter choledochoscopes.
Generally only one surgical instrument is deployed at a time into the common bile duct, or otherwise said instrument may be run combined in a tandem arrangement with the choledochoscope. Said tandem array typically also includes either an open working channel or other instrument, which is longitudinally attached. This tandem combination allows insertion of a single instrument tool via the working channel for deployment within the common bile duct. Use of said working channel may be problematic, however, if the required flow of irrigating fluid through the working channel is impaired by simultaneous deployment of an instrument through that same channel.
The terms “upper” and “lower” may be used herein to describe opposite ends of various components, or a relative position of various components. A component may include an “upper” end, which denotes the end that is axially oriented away from penetration of the patient, and “lower” denotes an end that is oriented toward penetration of the patient. Biliary and cystic duct exploration and related calculus removal procedures typically include a strategically distributed set of four or five ports. Each port may be generally positioned such that the lower ends are oriented toward a common focus or apex in the vicinity of the biliary tract. Various tubular instrument guides and laparoscopic surgical instruments may be inserted through these ports to accomplish the cholecystectomy and operative cholangiogram procedure, including dissecting forceps, scissors, grasping forceps, stone forceps, cholangiogram catheter, and cautery instruments. The cylindrical, tubular laparoscopic ports are typically 5-12 mm ID and of length adequate to penetrate through the abdominal wall to the area adjacent to the common bile duct, which is referred to as the porta hepatis. Laparoscopic ports also have valve mechanisms that prevent the loss of pneumoperitoneum, which is the gas pressure (typically under 12-15 cm H2O pressure) introduced into the peritoneal cavity to provide working space for instrument manipulation and to facilitate visualization of anatomic structures within the peritoneal cavity. Carbon dioxide is the gas employed most commonly to establish this insufflation of the patient's abdominal cavity during laparoscopic surgical procedures. The port optionally provides for the introduction of a tubular sheath through the port to extend the instrument access conduit deeper into the abdominal cavity. Both the port and introducer sheath may each provide inner and outer annular seals, with valves by which to sustain and regulate abdominal sufflation. The upper end of the laparoscopic port may contain a valve and a fitting for attachment to a CO2 source to control insufflation and desufflation. The port and the sheath may be fabricated from metallic o
Scott, III George L.
Wenner Donald E.
Browning Bushman PC
Dvorak Linda C. M.
Helmreich Loren G.
Ram Jocelyn
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