Surgery – Means for introducing or removing material from body for... – Material introduced into and removed from body through...
Reexamination Certificate
1999-07-22
2001-03-20
Weiss, John G. (Department: 3731)
Surgery
Means for introducing or removing material from body for...
Material introduced into and removed from body through...
C604S500000
Reexamination Certificate
active
06203520
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates generally to the therapeutic treatment of the gastrointestinal tract in a patient having gastrointestinal bleeding. More particularly, one embodiment of the present invention relates to a flexible irrigation tube for deploying a balloon tamponade device in the gastrointestinal tract. Further, the present invention relates to irrigation and aspiration of the stomach. While the present invention was developed for use in treating bleeding sites within the gastrointestinal tract, it may have uses in treating other ailments of the gastrointestinal tract as well as in other areas of medicine.
Often it is necessary to treat bleeding sites within the distal esophagus and proximal stomach, particularly to control bleeding from esophagastric varices. Patients experiencing bleeding esophageal varices are at a great risk for exsanguination and the serious complications of aspiration of blood and other gastric contents into the lungs. Therefore, diagnostic and treatment measures must be undertaken immediately to accurately identify the cause of bleeding and limit further bleeding to prevent patient death. In these circumstances, it is traditional and useful to aspirate the stomach of a patient with gastrointestinal bleeding prior to the practitioner performing any diagnostic or therapeutic procedures. This procedure is done to evaluate the magnitude and rate of bleeding and to reduce the risk of pulmonary aspiration by emptying the patient's stomach prior to a diagnostic or therapeutic endoscopic procedure. Currently, the available apparatus for aspirating the stomach utilizes a tube, syringe or aspiration bulb, and a basin filed with water. The patient's stomach is irrigated using the syringe and then emptied with the bloody returns from the stomach often being mixed with the irrigation fluid. Mixing of the bloody returns and the irrigation fluid results from the inevitable fluid carry over from the syringe. This prior technique is inefficient and dirty, and requires that the bloody gastric aspirate be transported and emptied into an adjacent basin or sink.
A common limitation of the prior technique is the spreading of blood and irrigation fluid on the operating room floor, the patient, and the personnel involved in the surgical procedure. Exposure of personnel to a patient's blood constitutes a serious risk for the transmission of diseases, such as AIDS or hepatitis, particularly hepatitis A, B, and C. Exacerbating the spread of blood and irrigating fluid throughout the operating room is the fact that these procedures are often required to be performed in great haste because the patient is actively bleeding.
Another limitation associated with the prior therapeutic technique is the general difficulty in controlling the volume of irrigation fluid used, and to account for the volume of bloody returns. Mixing of fluid inhibits an accurate determination of the volume of irrigation fluid ingested or removed. As a consequence, the patient may receive an excess amount of irrigation fluid that passes from the stomach into the intestine and is then absorbed. Similarly, the volume of blood in the bloody returns cannot be measured quantitatively and in a patient with active bleeding can be a number of liters.
Normally, aspiration of the patient's stomach is performed by passing an oral or nasal gastric tube into the stomach, aspirating the contents which are then examined by the practitioner for the presence of blood, and if blood is present the stomach is irrigated and emptied in preparation for a diagnostic or a therapeutic endoscopic procedure.
Such an endoscopic examination requires the use of expensive sophisticated equipment under the direction of a physician trained in endoscopy techniques. Current therapeutic techniques necessitates that prior to performing an endoscopic examination the oral and/or nasal tube utilized for irrigation and aspiration must be removed and the endoscope passed into the stomach. Subsequently, or as part of the examination, the practitioner may attempt to control the bleeding by one of the many therapeutic techniques that are available including: injection of the bleeding site; thermal methods that coagulate the bleeding site; banding, which is the placement of rubber bands around the bleeding site to produce clot formation and stop the bleeding; or the use of a balloon tamponade device. Currently, the deployment of a tamponade balloon to stop variceal bleeding involves backloading the tamponade balloon on the endoscope prior to passage of the tamponade balloon into the patient over the endoscope.
A limitation common to prior therapeutic techniques utilizing endoscopic treatment is the necessity of having a practitioner trained in endoscopy available. Presently, absent the services of a practitioner trained in endoscopy, the deployment of the balloon tamponade device is not a treatment alternative. Therefore, there are life threatening situations where the patient can not receive treatment with the balloon tamponade device to control bleeding from the esophageal varices for lack of either a medical facility and/or a trained practitioner. The absence of the therapeutic technique and/or the passage of time may compound and complicate the patient's medical condition, particularly where the patent is experiencing massive variceal bleeding and is in danger of exsanguination. p Another limitation associated with the prior therapeutic techniques is the inability to perform irrigation and aspiration while the balloon tamponade device is being deployed. As a result, blood from the actively bleeding injury inhibits the practitioner's ability to visualize the bleeding site with an endoscope and properly diagnose the ailment. Even if the endoscope includes a passage for suction, this small bore passage, often on the order of 3 mm in diameter, is not suited for the removal of large blood clots and the large volume of blood associated with active bleeding of esophageal varices.
A further limitation associated with the prior therapeutic techniques of passing the tamponade device over the endoscope relates to the complex structure of the endoscope. Specifically, an endoscope often includes a complicated operating handle, an umbilical connection to a light source, a video connection, and connection to a suction apparatus. The physical constructs of the endoscope often render the apparatus cumbersome, and requires specialized staff, such as an anesthesiologist, and equipment for tamponade balloon passage not readily available outside of a sophisticated medical treatment facility. Moreover, because of the number of attachments to the endoscope, a treatment device must be back loaded on the endoscope prior to insertion into the patient. This limitation often requires that the endoscope be inserted for diagnosis and then withdrawn to be fitted with a treatment device before being reinserted. Withdrawal and reinsertion of the endoscope prior to treatment of the bleeding site unduly complicates the procedure and expends valuable time in delivering life saving treatment.
Although the prior techniques are steps in the right direction for the treatment of esophagastric variceal bleeding, the need for improvement still remains. The present invention satisfies this need in a novel and unobvious way.
SUMMARY OF THE INVENTION
One form of the present invention contemplates an apparatus for treating a bleeding site within a patient's gastrointestinal tract. The apparatus comprising: an elongated tube configured to be insertable into a gastrointestinal tract; a treatment device disposed on and slidable along an outer surface of the elongated tube, the treatment device for controlling bleeding; and a fluid reservoir selectively coupled to the tube for receiving fluid through the elongated tube.
Another form of the present invention contemplates an apparatus for treating a bleeding site within a gastrointestinal tract. The apparatus comprising: an elongated tube configured to be insertable through an esophag
Cho David J.
Weiss John G.
Woodard Emhardt Naughton Moriarty & McNett
Zimmon Science Corporation
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