Modern medical techniques encompass the removal of kidney stones, the performance of biopsies and other operations by passing an endoscope (a telescope-like device, such as a cystoscope, ureteroscope, laparoscope, bronchoscope, colonoscope, arthroscope, etc.) through various orifices in the body. Such procedures often obviate the necessity for open surgery. In a typical endoscopic procedure, such as removal of a stone from a ureter, the endoscopist passes a variety of devices through the urethra, into the bladder and into the ureter in which a stone may be lodged. The stone is then removed in the reverse order.
The above-identified optical-medical devices generically include an optical pathway with one or more working ports adjacent to an eyepiece of the optical pathway. The working ports include valves which are opened to allow the endoscopist to pass tubes, biopsy forceps, grasping forceps, laser fibers, catheters, etc., through the ports and into the appropriate passageway or organ in the body. The working ports are partially sealed by rubber diaphragms while the working devices are passing through the ports. During these procedures, the bladder, for example, is irrigated with water (that is, the bladder is pressurized with water through the endoscope) to prevent the bladder from occluding the end of the optical pathway and to prevent orifices such as the ureteral orifices from being obscured. Thus, the working ports are continually leaking fluid (water mixed with various bodily fluids). When a working device is used through a working port, a stream of fluid may exit the working port adjacent to the eyepiece so as to splash the endoscopist. This may occur at the time the working device is removed. The fluid may continuously exit around the working device because the seal between the device and the working port is not fluid tight. While the physician is typically wearing a mask, gloves and perhaps eye protection, a common occurrence is for fluid to enter the eye of the physician.
In a typical situation, a patient with a stone lodged in the ureter may undergo endoscopic treatment to remove the stone. A cystoscope having one or more working ports is first passed through the urethra so that the ureteral orifice can be located inside the bladder. Water is introduced into the bladder under pressure through the cystoscope to distend the bladder, as described above. The ureteral orifice of interest is located and a guidewire is passed through one of the open working ports into the ureter. The guidewire is narrower than the opening of the port and a backspray of irrigating fluid mixed with bodily fluid occurs. The bodily fluids often include blood because the ureter is already inflamed or cut by the stone lodged therein.
The cystoscope is then removed, leaving the guidewire in place, and a catheter with a dilating balloon (similar to an angioplastic balloon) is passed over the guidewire. The balloon cracks the ureter up to the position of the stone to allow the subsequent passage of a ureteroscope over the guidewire. The ureteroscope is passed over the guidewire and into the ureter until the end of the ureteroscope is positioned adjacent to the stone. The ureteroscope's working port is then opened so that a stone grasping basket can be passed there through to the position of the stone. While the working port is opened and while the stone grasping basket is passed through the working port, backflow occurs and the physician is again sprayed with a mixture of water, blood and other bodily fluids. To maintain the ureteral wall dilated so that the basket can grasp the stone, a high-pressure water flow is introduced into the ureteroscope and ureter, resulting in substantial backspray during manipulation of the grasping basket. The stone is then grasped by the grasping basket, and the grasping basket, with the stone and ureteroscope are removed. The cystoscope is then reinserted into the urethra so that a stent can be placed into the ureter to aid in healing thereof.
As is apparent from the above, throughout the procedure, the physician is continuously exposed to backpressure spray from the working port, either while the working ports are open or while a working tool is being inserted or removed through the working port.
As is well known, the occurrence of Acquired Immune Deficiency Syndrome (AIDS) and Hepatitis B (viruses) merits serious concern for health care professionals, especially those in contact with bodily fluids, as these workers are at the highest risk of infection. It has been shown that the virus responsible for AIDS (Human Immunodeficiency Virus, HIV) is contained in the bodily fluids described above and that contamination and spread could occur if mucous membranes, open cuts, conjunctivae or puncture wounds were contacted. The Hepatitis B virus can be transmitted through contaminated blood and is significantly more infectious than HIV. Therefore, a need exists for a method and device which can be used with conventional endoscopic devices to shield the endoscopist from backpressure spray from the working ports.
In addition to the above, reverse contamination from the endoscopist to the patient can occur because the wires and catheters are being passed into and out of the working ports adjacent to the physician's face. Contamination from the physician's mask and face are easily encountered, thereby introducing possible infection into the patient's bladder and ureter. Therefore, a need also exists for a method and device to prevent reverse contamination during endoscopic procedures.
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USPTO Backgrounds