Surgery – Means for introducing or removing material from body for... – Material introduced into and removed from body through...
Reexamination Certificate
1999-09-24
2002-03-19
Mendez, Manuel (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Material introduced into and removed from body through...
C604S246000
Reexamination Certificate
active
06358224
ABSTRACT:
FIELD OF THE INVENTION
This invention relates generally to an irrigation system to be used during surgery and, more particularly, to an irrigation and vacuum system for use in conjunction with endoscopic or minimally invasive surgery.
BACKGROUND OF THE INVENTION
Laparoscopic surgery was first performed in France in 1987 and in the United States in 1988. Since that time laparoscopic surgery, also known as minimally invasive or endoscopic surgery, has grown at a phenomenal rate. Many procedures that previously used open surgery techniques are now done using a laparoscopic approach.
While laparoscopic surgery initially developed with the removal of gall stones, laparoscopic surgery is now used for many other surgical procedures including hernia repair, appendectomy, pediatric, gynecological, genitourinary, bowel, colorectal, gastroduodenal, and vascular surgery, just to name some examples. Laparoscopic or minimally invasive surgery is the latest rage in new surgery techniques. By use of laparoscopic surgery, infection and trauma for the patient is reduced. The patients are able to go home much earlier and have much less effect from the surgery. The pain and suffering normally associated with surgery is greatly reduced. Laparoscopic surgery is truly the wave of the future in surgical techniques.
In normal laparoscopic surgery, a trocar and cannula are inserted through the esophagus, around muscle and other tissue, and into a body cavity where the surgeon is to perform the surgical procedure. As the surgical procedure is being performed, it is necessary to remove the fluids from the body cavity that may interfere with the ability to physically see what is occurring. As would occur in open surgery, laparoscopic surgery needs to provide irrigation to the area where the procedure is being performed and suctioning to remove the irrigation fluid as well as the body fluids that interfere with the ability to visually see what is occurring.
Using an appendectomy as an example of the surgery that is being performed laparoscopically, typically there would be (a) a puncture for the endoscope, (b) a puncture for the appendix extractor, and (c) a puncture for the insertion of the surgical instruments. It is necessary for the surgeon to be able to see through the endoscope what is occurring in the body cavity. The providing of irrigation fluids to the body cavity and the removal of those fluids is necessary for the successful performance of the appendectomy.
In the past, irrigation is normally provided through a trumpet valve via one of the punctures to the body cavity. The trumpet valve is connected to a source of (a) saline solution for irrigation purposes and (b) vacuum for extraction of the irrigation fluid and body fluids. Depending upon which portion of the trumpet valve is pushed, either irrigation or vacuum is provided. However, during long periods of non-use, neither irrigation nor vacuum will be provided to the patient.
Typically, the irrigation fluid is provided under pressure by means of a pump to the trumpet valve. It is important to the surgeon to have pressurized irrigation fluid immediately available with essentially no delay upon pushing the trumpet valve. The surgeon does not want to have to reach and flip other switches, such as hand or foot switches, or push other buttons other than pushing the trumpet valve itself. In other words, the surgeon wants to push one button on the trumpet valve to provide irrigation fluid and push another button on the trumpet valve to remove the irrigation fluid and body fluids. When neither are pushed, neither irrigation fluid nor a vacuum are being provided to the body cavity of the patient. The surgeon wants either irrigation fluid or vacuum to be available instantaneously upon demand. Moreover, providing a separate switch has the additional disadvantage of increased controls and complexity of the system plus additional expense.
In the past, pumps that would provide the irrigation fluid would have to be switched ON to provide the fluid and then turned OFF. When the pump was switched ON, there would be a delay of several seconds before the irrigation fluids are provided under pressure. This delay is disadvantageous and unacceptable to the surgeons. To avoid the foregoing disadvantage, the pump could be designed to run continuously. However, if the pump is left ON continuously and no fluids are flowing so the pump is operating in a “deadhead” condition, the pump has a tendency to overheat as it constantly rotates at a relatively high speed without the fluids flowing through the pump which provide cooling for the pump. Excessive heating of the pump affects the reliability of the pump, can cause hot fluid to be supplied to the patient, and can even blow off the connections as pressure builds. Therefore, in systems with continuously running pumps, some type of external cooling must be provided for the pump, which is a problem when performing laparoscopic surgery.
Consequently, it would be advantageous to provide a system which can supply irrigation instantaneously on demand without requiring a separate ON/OFF switch and without resulting in overheating of the pump. Also in the past, a tremendous expense incurred in laparoscopic surgery is the replacement of the entire system between procedures. Normally after a laparoscopic surgery technique is performed on one patient, the entire irrigation system (including the pump and all valving associated therewith) is thrown away and replaced with a new laparoscopic irrigation system before a new procedure is performed on a new patient.
The motor portion of the pump, including the windings and coils, is fairly expensive. If the windings and coils portion of the pump can be reused, this could save a considerable amount of money. The irrigation fluid itself is sterile and does not contaminate the pump. If backflow from the trumpet valve is prevented, it may be possible to reuse either a portion or even the entire pump. By the present invention, it is found that a portion of the pump can be replaced and still save the major expense that may be incurred by replacing the entire pump.
SUMMARY OF THE INVENTION
The present invention overcomes the foregoing disadvantages by providing a pump that can be switched from one operating condition to another operating condition and still not be turned OFF. By switching to a second operating condition, the pump can be ready to instantaneously deliver irrigation fluid under pressure and still avoid the problem of overheating as will be discussed further hereinbelow in conjunction with the present invention.
In endoscopic surgery, such as laparoscopic surgery which is provided through the abdomen, a saline solution is normally provided through a trumpet valve and a cannula into a cavity of the patient's body. The saline solution is pumped by a positive pressure pump. By pushing one button on the trumpet valve, the saline solution is pumped from the pump into the cavity of the patient's body. By releasing the first button on the trumpet valve and pushing the second button, the same cannula is now connected to a source of vacuum. The source of vacuum will suck the saline solution and any body fluids at the end of the tube in the cavity of the patient's body back toward the vacuum source with the fluids being collected in a vacuum cannister.
So that the entire system does not have to be thrown away when switching from patient to patient, the pump has been made partially disposable. The head of the pump that includes the impellers is made from a medical grade, yet disposable, plastic. By a simple hand twisting action, the head of the pump is connected to the body of the pump. The body of the pump may be used repeatedly.
Because the pump normally operates at 12 volts DC, if it continues to operate at that voltage at a no-load or deadhead condition, the pump will overheat. To eliminate the problem of overheating, if fluid does not flow through the pump for a predetermined time, the voltage being applied to the pump will be reduced. The reduced voltage reduces the speed
Ditterline Andrew F.
Tims Jerry L.
Mendez Manuel
Tyco Healthcare Group LP
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