Patent Description:
Surgical smoke and aerosol, or plume, is created when energy is imparted to tissue cells during surgery. For example, when laser or electrosurgical energy is delivered to a cell, heat is created. The heat vaporizes the intracellular fluid, which increases the pressure inside the cell and eventually causes the cell membrane to burst. When this happens, a plume of smoke containing mostly water vapor is released into the atmosphere of the operating room or doctor's office. At the same time, the intense heat created chars the protein and other organic matter within the cell, and causes thermal necrosis in adjacent cells. The charring of cells releases other harmful contaminants, such as carbonized cell fragments and gaseous hydrocarbons.

These small particles and gases are potentially hazardous if inhaled. If they are not evacuated, they become airborne and can be inhaled. This has led to the development and implementation of smoke evacuation systems during surgical procedures. A smoke evacuator is basically a vacuum pump with one or more filters designed to evacuate surgical smoke and aerosol from the operative site, filter out essentially all of the contaminants, and return the filtered air to the operating room. Different types of filters may be employed in hospital-grade smoke evacuators,
including High Efficiency Particulate Air (HEPA) filter, Ultra Low Penetration Air (ULPA) filters, and activated charcoal filters.

Research confirms the effectiveness of these filter media in screening out harmful contaminants. To extend their use, filters may be impregnated with an antimicrobial agent, to inhibit the growth and reproduction of microorganisms that become trapped in the filter.

The prior art also teaches that a suction canister may be installed upstream of the filter to receive any liquids suctioned during a procedure.

<CIT>discloses a prior art smoke evacuation system.

The subject invention is directed to a new and useful smoke evacuation system for use during an invasive or open surgical procedure. The system includes a disposable filter assembly or cartridge having a housing with an inlet port. A flow path is formed within the housing and it extends from the inlet port. A pleated filter element is disposed within the flow path for filtering smoke filled air flowing therethrough. A flexible conduit is connected to the inlet port of the filter assembly, and a smoke evacuator is connected to the flexible conduit for drawing smoke away from the surgical site and into the filter assembly through the conduit.

Preferably, the smoke evacuator includes a configurable smoke evacuation tube having a plurality of spaced apart smoke intake ports on a peripheral surface thereof. A slotted intake nozzle may be operatively associated with each smoke intake port to increase capacity. In one embodiment of the subject invention, the smoke evacuation tube has one open end and one closed end, wherein the open end is detachably coupled to the flexible conduit. In another embodiment of the subject invention, the arcuate smoke evacuation tube is closed at both ends and a branching tube extends from a central section of the smoke evacuation tube for detachably coupling with the flexible conduit.

In yet another embodiment of the subject invention, the smoke evacuator includes a corrugated tube having a suction nozzle operatively associated with a distal end thereof and a rotatable coupling is operatively associated with a proximal end thereof for detachable connection with a fitting on the distal end of the flexible conduit. The suction nozzle may be defined by an elongated intake tube, which can include an outwardly flared intake port or a bowed intake flange having a plurality of intake ports formed therein.

These and other features of the smoke evacuation system of the subject invention and the manner in which it is manufactured and employed will become more readily apparent to those having ordinary skill in the art from the following enabling description of the preferred embodiments of the subject invention taken in conjunction with the several drawings described below.

So that those skilled in the art to which the subject invention appertains will readily understand how to make and use the smoke evacuation system of the subject invention without undue experimentation, preferred embodiments thereof will be described in detail herein below with reference to certain figures, wherein:.

Referring now to the drawings wherein like reference numerals identify similar structural features and/or elements of the subject matter disclosed herein, there is illustrated in <FIG> a smoke evacuation system constructed in accordance with a preferred embodiment of the subject invention and designated generally by reference numeral <NUM>. The smoke evacuation system <NUM> is adapted and configured for use during an invasive or open surgical procedure to evacuate surgical smoke from the operative site, filter out essentially all of the contaminants in the smoke, and return the filtered air to the operating room.

Referring to <FIG>, the smoke evacuation system <NUM> includes a flexible or otherwise configurable smoke evacuation tube <NUM> that is dimensioned and configured to at least partially surround an open incision in the abdominal wall of a patient. For example, the configurable smoke evacuation tube <NUM> can be arranged in a curved or arcuate configuration relative to the open incision, as illustrated in <FIG>.

The smoke evacuation tube <NUM> may be readily secured to the surgical drape <NUM> covering the patient by a plurality of clamps <NUM> (see <FIG>). The proximal end of the smoke evacuation tube <NUM> it is connected to a disposable filter cartridge assembly <NUM> by way of a flexible conduit <NUM>. Those skilled in the art will readily appreciate that the diameter and length of the smoke evacuation tube <NUM> can vary depending upon the application, patient or surgical procedure with which it is employed. Similarly, the length of the flexible conduit <NUM> can vary depending upon the application and other physical parameters associated with the operating room.

The filter cartridge <NUM> is operatively associated with or otherwise releasably engaged within a reception port <NUM> in the front panel <NUM> of a surgical gas delivery device housing <NUM> that contains a vacuum pump <NUM> for drawing smoke into the smoke evacuation system <NUM>. An example of such a gas delivery device with a vacuum pump is disclosed in commonly assigned <CIT>, the disclosure of which his incorporated herein by reference in its entirety.

Referring now to <FIG>, the filter cartridge <NUM> has a generally cylindrical plastic housing <NUM> with a front end cap <NUM> and a rear end cap <NUM>. The front end cap <NUM> includes inlet port <NUM> for connecting with a proximal end of the flexible conduit <NUM>. The front end cap <NUM> also includes outlet vent slots <NUM> opening to atmosphere for permitting filtered air to return back into the operating room. The rear end cap <NUM> incudes a sealed rear outlet port <NUM> for communicating with an inlet side of the vacuum pump <NUM> and a sealed rear inlet port <NUM> for communicating with an outlet side of the vacuum pump <NUM>, as shown in <FIG>.

Moreover, the rear outlet port <NUM> in rear end cap <NUM> communicates with the inlet port <NUM> in the front end cap <NUM>, while the rear inlet port <NUM> in rear end cap <NUM> communicates with the outlet vent slots <NUM> in the front end cap <NUM>. That is, an internal flow path <NUM> is formed within the housing <NUM> of filter cartridge <NUM> and it extends between the front inlet port <NUM> in front end cap <NUM> and the rear outlet port <NUM> in the rear end cap <NUM> to channel smoke filled air drawn into the filter <NUM> by the vacuum pump <NUM>. A pleated filter element <NUM> is disposed within the flow path <NUM> for filtering smoke drawn into the filter cartridge <NUM> by the vacuum pump <NUM>. The media of filter element <NUM> can take the form of a High Efficiency Particulate Air (HEPA) filter, an Ultra-Low Penetration Air (ULPA) filter, or the like.

It is envisioned that a second filter element (not shown) can be disposed within the housing <NUM> of filter cartridge <NUM> for filter air entering the filter cartridge <NUM> from the outlet side of the vacuum pump <NUM> before it is delivered back into the operating room through the outlet vent slots <NUM> in the front end cap <NUM>. It is also envisioned that an internal reservoir (not shown) can be formed within the housing <NUM> of filter cartridge <NUM>, in line with the filter element <NUM>, to accommodate the accumulation of fluids drawn into the cartridge by the vacuum pump <NUM>.

The distal end of the flexible conduit <NUM> extending from the inlet port <NUM> in the front end cap <NUM> of the housing <NUM> of filter cartridge <NUM> includes a mechanical fitting <NUM> for rotational engagement with a corresponding rotatable coupling <NUM> located on the proximal end of the smoke evacuation tube <NUM>. A rotational coupling arrangement of this type is disclosed, for example, in commonly assigned <CIT>, the disclosure of which is incorporated herein by reference in its entirety. The distal end 12a of the configurable smoke evacuation tube <NUM>, opposite the coupling <NUM>, is plugged or otherwise closed.

The smoke evacuation tube <NUM> has a plurality of spaced apart smoke intake ports <NUM> located on a radially inner peripheral surface thereof for admitting smoke generated during a surgical procedure into the central lumen of the smoke evacuation tube <NUM>, as best seen in <FIG>. More particularly, smoke filled air is drawn into the intake ports <NUM> through the action of vacuum pump <NUM> in device housing <NUM>. Those skilled in the art will readily appreciate that the size and spacing of the intake ports <NUM> can vary depending upon the application or procedure. As shown in <FIG>, at least two clamps 16a and 16b are associated with the smoke evacuation tube <NUM> for securing the tube to a surgical drape or the like. More or fewer clamps could be employed.

Referring to <FIG>, there is illustrated another embodiment of the smoke evacuation system of the subject invention, which is designated generally by reference numeral <NUM>. This smoke evacuation system is substantially similar to smoke evacuation system <NUM> in that it includes a flexible and configurable smoke evacuation tube <NUM> with a closed distal end 112a and a coupling <NUM> at its proximal end, a disposable filter cartridge <NUM>, and a flexible conduit <NUM> with a mechanical fitting <NUM> extending between the smoke evacuation tube <NUM> and the filter cartridge <NUM>.

Smoke evacuation system <NUM> differs from smoke evacuation system <NUM> in that a slotted intake nozzle <NUM> is operatively associated with each smoke intake port <NUM> formed in the periphery of smoke evacuation tube <NUM>. More particularly, each slotted nozzle <NUM> include a central stem <NUM> which is engaged in a corresponding intake port <NUM> and a generally rectangular body portion <NUM> that has an elongated smoke intake slot <NUM>. The smoke intake slots <NUM> advantageously increase the overall smoke evacuation capacity of the system <NUM> relative to system <NUM>.

Referring now to <FIG>, there is illustrated another embodiment of the smoke evacuation system of the subject invention, which is designated generally by reference numeral <NUM>. This system is substantially similar to smoke evacuation system <NUM> in that it includes a configurable smoke evacuation tube <NUM>, a disposable filter cartridge <NUM> and a flexible conduit <NUM> extending between the smoke evacuation tube <NUM> and the filter cartridge <NUM>. The smoke evacuation tube <NUM> also includes slotted intake nozzles <NUM> operatively associated with each smoke intake port <NUM>.

Smoke evacuation system <NUM> differs from smoke evacuation system <NUM> in that the smoke evacuation tube <NUM> is closed or otherwise plugged at both of its ends 212a, 212b, and a branching tube <NUM> extends from a central section of the smoke evacuation tube <NUM> to detachably connect with the flexible conduit <NUM> extending to the filter cartridge <NUM>. More particularly, the proximal end of the branching tube <NUM> includes a rotational coupling <NUM> for connection with the fitting <NUM> on the distal end of flexible conduit <NUM>. In this embodiment, clamps 216a and 216b are associated with the branching tube <NUM>, and others may be associated with the smoke evacuation tube <NUM>, although not shown.

Referring to <FIG>, there is illustrated yet another embodiment of the subject invention, which is designated generally by reference numeral <NUM>. This embodiment is similar to the previously disclosed embodiments of the subject invention in that it includes a disposable cartridge <NUM> connected to a flexible conduit <NUM> that has a mechanical fitting <NUM> at a distal end thereof for connection with a rotational coupling <NUM>. However, in this embodiment, a corrugated smoke evacuation tube <NUM> extends from the coupling <NUM>.

The corrugated smoke evacuation tube <NUM> has an open tapered distal end section <NUM> for receiving a suction nozzle 380a-380c. More particularly, suction nozzle 380a is defined by an elongated cylindrical intake tube 382a having an inlet port 384a, suction nozzle 380b is defined by an elongated intake tube 382b having an outwardly flared intake port 384b, and suction nozzle 380c is defined by an elongated intake tube 382c having a bowed intake flange 384c having a plurality of intake ports 386c formed therein.

In this embodiment of the invention, a drape clip <NUM> can be associated with the flexible conduit <NUM>, adjacent the fitting <NUM>. During a procedure, a surgeon or surgical assistant can select one and attach one of the suction nozzles 380a-380c to the distal section <NUM> of the tube <NUM> and dynamically position that suction nozzle in or near the incision, to provide a more direct means of smoke evacuation than the previously disclosed embodiments of the subject invention, wherein the smoke evacuation tubes are typically arranged in a more stationary position relative to the incision.

Claim 1:
A smoke evacuation system (<NUM>) for an open surgical site, comprising:
a) a filter assembly (<NUM>) including a housing (<NUM>) having an inlet port (<NUM>), an internal flow path (<NUM>) communicating with the inlet port (<NUM>), and a filter element (<NUM>) disposed within the flow path (<NUM>);
b) a flexible conduit (<NUM>) having a proximal end connected to the inlet port (<NUM>) of the filter assembly (<NUM>); and
c) a smoke evacuator (<NUM>) configured for detachable connection to a distal end of the flexible conduit (<NUM>) for drawing smoke filled air away from the surgical site and into the filter assembly (<NUM>) through the conduit (<NUM>), characterized in that:
d) the housing (<NUM>) comprises a front end cap (<NUM>) and a rear end cap (<NUM>), the front end cap (<NUM>) including an inlet port (<NUM>) for connecting with the approximate end of the flexible conduit (<NUM>), the front end cap (<NUM>) also including outlet vent slots (<NUM>) opening to atmosphere for permitting filtered air to return back into the operating room, and
e) the rear end cap (<NUM>) includes a sealed rear outlet port (<NUM>) for communicating with an inlet side of the vacuum pump (<NUM>) and a sealed rear inlet port (<NUM>) for communicating with an outlet side of the vacuum pump (<NUM>); and
f) the internal flow path (<NUM>) is formed within the housing (<NUM>) of the filter assembly (<NUM>) and it extends between the front inlet port (<NUM>) in the front end cap (<NUM>) and the rear outlet port (<NUM>) in the rear end gap (<NUM>) to channel smoke filled air drawn into the filter (<NUM>) by the vacuum pump (<NUM>).