Surgery – Means for introducing or removing material from body for... – Gas application
Reexamination Certificate
1998-10-22
2003-04-08
Casler, Brian L. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Gas application
C604S028000
Reexamination Certificate
active
06544210
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to surgical procedures and, more specifically, to a device and method for obtaining a smoke-free environment within the surgical field during laparoscopy.
BACKGROUND OF THE INVENTION
Laparoscopy is a fast growing surgical modality widely used in the treatment of certain prevalent physical ailments. Laparoscopy entails the introduction of an endoscope, light source and surgical instruments through ports formed in the patient's abdomen. In order to facilitate the procedure, the patient's abdominal cavity is inflated with a suitable gas to give the surgeon additional working area and minimize obstruction. Generally, laparoscopy avoids the risks of laparotomy, which requires the surgeon to open the abdomen and carry out the required procedure by his or her direct viewing.
The laparoscopic procedure is designed to avoid the surgical complications involved in a conventional laparotomy by allowing a surgeon to view the target site without opening up the patient's abdominal cavity. In a diagnostic laparoscopic procedure, only one channel is required through the patient's abdominal wall into the patient's abdominal cavity, into which the surgeon positions the laparoscope (laparoscopic camera) needed for viewing the underlying and overlying abdominal tissues and/or potential surgical field.
However, when the laparoscopic procedure requires tissue removal by ablation, several channels through the abdominal wall are required. These include a channel for the laparoscopic camera needed for viewing the surgical field, a channel for the laser or electrosurgical instrument used to burn the target tissue, a channel for insufflation (introduction of CO
2
gas into the patient's cavity to expand the patient's cavity) with CO
2
gas, and a means for withdrawal of gas and smoke. Note that insufflation with a suitable gas is required during the laparoscopic procedure so as to provide both increased cavity volume and optimal visual conditions during the surgical procedure. A smoke clearing system is usually employed in order to maintain both the visual clarity and proper abdominal pressure within the expanded cavity during the procedure.
A common procedure for positioning the laparoscopic assembly in the patient's abdominal cavity includes first making an incision into the patient's abdominal wall through which a large gauge needle is inserted. A suitable gas, typically CO
2
, is then introduced into the patient's abdominal cavity through the needle. The needle is then replaced with a trocar, which is then removed leaving behind a sleeve, or cannula, through which a laparoscope is introduced into the abdominal cavity. In order to perform laser or electrosurgery one or two additional small incisions are made in the abdominal wall over the surgical site and cannula/trocar assemblies positioned accordingly. These cannula/trocar assemblies may be used for the positioning of the insufflation tube as well as any other surgical instruments that may be required for the particular laparoscopic procedure.
A laparoscopic procedure typically requires a surgeon to employ either electrosurgery or laser surgery within the confined space of the patient's abdominal cavity. This surgery typically involves tissue burning or ablation. This tissue burning leads to the creation of smoke. Surgical smoke within the confines of a patient's abdominal cavity reduces the surgeon's view of the surgical site, increases the patient's hematocrit levels, and causes delays in the surgery while the smoke is cleared from the laparoscopic field. Efficient removal of the smoke is thus a necessity for the surgical team during the laparoscopic procedure.
One method for removing smoke from the laparoscopic field is described in U.S. Pat. No. 4,735,603. This patent describes an elaborate and complex system for re-circulating and cleansing the smoke-laden gas produced inside a patient's abdominal cavity during a laparoscopic procedure. The system consists of a CO
2
gas pump that pumps gas into the patient's abdominal cavity by way of a solenoid control valve and a filter of such pore size as to remove bacteria size debris. Gas and smoke within the cavity are then evacuated by a return line, through a smoke clearing filter, a solenoid control valve, and a fluid trap before returning to the pump. A separate control module monitors the system for pressure variations and allegedly adjusts the pressure accordingly. The overall target cavity pressure is between 16-20 mm of Hg relative to atmospheric pressure. If the pressure exceeds 25 mm Hg or falls below 10 mm Hg the central control module closes the solenoid valves, which isolates the patient from the continued actions of the pump and allows the pressure to adjust accordingly. This system is large, cumbersome and can be costly.
Other laparoscopic smoke removal systems include: (1) suction devices which permit some air to be removed from the patient's cavity but require an equal input of gas back into the patient; (2) removal of smoke by opening a stopcock on one of the trocars, thus allowing the insufflation gas, laden with smoke, to be carried directly into the operating room; or (3) use of an adapted probe which can be inserted into the trocar for direct removal of smoke from the surgical site. Generally, the present systems are bulky, non-disposable, of complex design, are costly, and relatively large in size. Some devices also require connections to a house vacuum system within the surgical room. As such, it is unlikely that hospitals or health care offices that do not engage in numerous laparoscopic procedures will be able to justify the purchase of a conventional smoke removal system.
There is thus a need for a cost-effective solution to the removal of surgical smoke during a laparoscopic procedure.
There is also a need for a disposable, pre-sterilized smoke evacuation system that can be economically obtained and utilized by hospitals that do not routinely engage in laparoscopic procedures. It is with the above-referenced problems in mind that the present invention was developed.
SUMMARY OF THE INVENTION
The present invention is a smoke evacuation system utilizing a disposable inline gas pump/fan and filter apparatus comprising a housing defining an interior chamber and an inlet port and an outlet port. There is preferably an inline fan unit positioned in the interior chamber and a filter positioned in the interior chamber. The fan unit is preferably positioned between the inlet port and the filter. The apparatus has a power supply operably connected to the fan unit wherein the fan unit draws smoke-laden air from the patient's body cavity through the inlet port, past the fan, and pushes air through the filter, and the cleansed air is passed through the outlet port. Thereafter the cleansed air is re-introduced into the patient's cavity.
The present invention is connected between two laparoscopic cannula/trocar assemblies and works to eliminate surgical smoke and vapor, which has been created by the laser or other surgical devices, from the patient's abdominal, or other expanded body cavity during a laparoscopic procedure. The present invention comprises a small, portable, and disposable smoke clearing device which houses at least a fan unit and a filter media. Attached on one end of the smoke clearing device is a first flexible hollow tube attached to one of the cannula/trocar assemblies. Attached on the opposite end of the smoke clearing device is a second flexible hollow tube attached to the other cannula/trocar assembly, or other surgical device, inserted into the patient's abdominal or other body cavity.
The smoke clearing device is operated during a laparoscopic procedure to draw smoke from the surgical site out of the abdominal cavity, through the filter media, and return filtered gas back into the abdominal cavity. The present invention can best be understood by reference to the drawings and the detailed description below, wherein lik
Smith Shawn P.
Trudel Gregory J.
Casler Brian L.
Jagtiani + Guttag
Thanh LoAn H.
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