Abstract:
The present invention relates to an improved smoke evacuation device for use in laparoscopic surgeries. One improvement is a hydrophilic wick positioned within the inlet system of the smoke device for absorbing moisture and trapping surgical waste entering the smoke evacuation device. The second improvement is a multi-outlet valve inserted into the outlet system of the smoke evacuation device to enable quick depressurization of the surgical site.

Description:
CROSS REFERENCE TO RELATED PATENT APPLICATION 
     This application claims the priority benefit of U.S. Provisional Patent Application No. 60/904,270, filed Mar. 1, 2007. 
    
    
     FIELD OF THE INVENTION 
     The invention relates to surgical procedures and, more specifically, to a device for more efficiently removing surgical waste and vapor 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&#39;s abdomen. In order to facilitate the procedure, the patient&#39;s abdominal cavity is inflated with a suitable gas typically CO 2  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. 
     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&#39;s cavity to expand the patient&#39;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&#39;s abdominal cavity includes first making an incision into the patient&#39;s abdominal wall through which a large gauge needle is inserted. A suitable gas, typically CO 2 , is then introduced into the patient&#39;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&#39;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&#39;s abdominal cavity reduces the surgeon&#39;s view of the surgical site, increases the patient&#39;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. 
     Although a laparoscopic evacuation system (“lapevac system”) is effective in maintaining cavity inflation pressure, one problem that occurs during its operation is the clogging of the inlet tube and filter by solid waste, water and humidity carried out of the abdominal cavity by the incoming waste stream. Because the cavity is moist and may be heated above normal temperature by some surgical procedures such as cauterization, surgical wastes can be driven off the cavity wall and internal organs in the form of particles, vapor, and liquids from broken cells and tissues. In addition, vapors within the cavity itself can be drawn into the waste stream. Another problem that may occur during laparoscopic surgery is the insufficient removal of waste vapor from the cavity, stratification of water vapor in the cavity as well as other visualization problems. 
     Therefore, there is a need in the field for an improved laparoscopic surgical system that is designed to prevent clogging of the inlet and filter by surgical waste and that will reduce or eliminate stratification of smoke and water vapor in the abdominal cavity during laparoscopic surgery 
     SUMMARY OF THE INVENTION 
     The present invention is an improvement of a laparoscopic surgical device that comprises a smoke removal apparatus having a housing, inlet means for defining an inlet pathway for impure gas from a surgical cavity to the housing, wherein the inlet means includes locking means for connecting the surgical cavity to the inlet pathway, filter means for filtering impurities from impure gas to form filtered gas, outlet means for defining an outlet pathway for the filtered gas from the housing to the surgical cavity, and a fan for drawing impure gas from the surgical cavity through the inlet means and through the filter means to form the filtered gas and for driving the filtered gas through the outlet means into the surgical cavity, wherein the outlet means are adapted to a laparoscopic surgical instrument assembly, the improvement comprising a hydrophilic wick inserted into and attached to the locking means of the inlet means. 
     In a separate improvement, the improvement to the smoke removal apparatus comprises a multi-outlet valve incorporated into the outlet means. 
     In an additional embodiment, the improvement to the smoke removal apparatus comprises both a hydrophilic wick inserted into and attached to the inlet means and a multi-outlet valve incorporated into the outlet means. 
     One object of the present invention is to reduce or eliminate blocking of the inlet means by surgical waste. 
     A second object of the present invention is reduce or eliminate stratification of surgical smoke and water vapor in the abdominal cavity by supplying a venting valve on the outlet means of the surgical smoke removal device to effect quick removal of smoke and water vapor. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The nature and mode of operation of the present invention will now be more fully described in the following detailed description of the invention taken with the accompanying drawing figures, in which: 
         FIG. 1  is a schematic view of a laparoscopic smoke evacuation system of the prior art depicting the arrangement of the smoke evacuation system during laparoscopic surgery; 
         FIG. 2  is a top perspective view of a typical disposable laparoscopic smoke evacuation system with the improvements of the present invention; 
         FIG. 3  is an exploded top perspective view of the disposable laparoscopic smoke evacuation system shown in  FIG. 2 ; 
         FIG. 3A  depicts an enlarged view of the wick assembly of the present invention inserted into the inlet tube of the smoke evacuation system; 
         FIG. 4  is a top perspective view depicting the components of the wick assembly of the present invention in an assembled condition; 
         FIG. 4A  is a top perspective view of a partially disassembled wick assembly; 
         FIG. 4B  is a side view of the assembled wick assembly of the present invention; 
         FIG. 5  is a side view of the wick component of the wick assembly of the present invention; 
         FIG. 5A  is an end view showing one embodiment of the wick depicted in  FIG. 4 ; 
         FIG. 5B  is an isometric view of the wick shown in  FIG. 4 ; 
         FIG. 6A  is an isometric view of one embodiment of the two-way valve of the present invention in the divert mode; 
         FIG. 6B  is a top view of the two way outlet valve of the present invention in the divert mode; 
         FIG. 6C  is a side view of the two-way outlet valve from the side facing the outlet port in the divert mode; 
         FIG. 6D  is a cross section of the two-way valve taken along line H-H in  FIG. 5B  in the divert mode; 
         FIG. 7A  is an isometric view of the two-way valve showing the valve barrel in the open (flow through) mode; 
         FIG. 7B  shows a top view of the two-way valve in the open mode; 
         FIG. 7C  is a side view of the two-way valve in the open mode facing the side of the outlet showing the open channel to the valve outlet; 
         FIG. 7D  is a cross section of the two-way valve taken along line I-I in  FIG. 6B  showing the channel configuration when the valve is in the open mode; 
         FIG. 8A  is a top view of a second embodiment of the two-way outlet divert valve in the off mode; 
         FIG. 8B  is a top view of the second embodiment of the two-way outlet valve in the open mode; and, 
         FIG. 8C  is a top view of the second embodiment of the two-way outlet valve in the divert mode. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     At the outset, it should be appreciated that like drawing numbers on different drawing views identify identical structural elements of the invention. While the present invention is described with respect to what is presently considered to be the preferred embodiments, it is understood that the invention is not limited to the disclosed embodiment. 
     Furthermore, it is understood that this invention is not limited to the particular methodology, materials and modifications described and as such may, of course, vary. It is also understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present invention. 
     Adverting now to the figures,  FIG. 1  is a schematic view of a laparoscopic smoke evacuation system of the prior art depicting the arrangement of the smoke evacuation system during laparoscopic surgery. Smoke clearing device  10  includes housing  12 . Housing  12  may be made out of a variety of materials, such as a metal or a plastic, as long as the material facilitates the device&#39;s use and is preferably disposable. The housing  12  preferably has a generally rectangular box shape or it may have a generally cylindrical hollow shape, preferably with rounded corners. The housing  12  contains an inlet port  14  at one end, i.e., on one side and an outlet port  16  at the other end, i.e., on the opposite side. One end of an inlet tube  18  is connected to the inlet port  14 . One end of an outlet tube  20  is connected to the outlet port  16 . This tubing is preferably conventional sterile flexible plastic tubing. It is envisioned that conventional Luer lock structures  22  will be used to connect the tubes  18  and  20  to the housing  12 , but other locking structures could alternatively be used. 
     The patient&#39;s inner cavity, such as the abdominal cavity, is shown as  24  and the patient&#39;s skin is schematically shown as  25  in  FIG. 1 . The patient&#39;s tissue which is to be removed is shown as  26 , with the surgical smoke shown and indicated as  26   a ,  26   b , and  26   c . Three trocars containing laparoscopic surgical instrument clusters  28 ,  30  and  32  extend through the patient&#39;s skin  25  into the cavity  24 . 
     These groups of instruments are representative of the type of instruments that are typically used in laparoscopic surgery. Each instrument cluster includes a cannula/trocar for introducing the instrument into the patient&#39;s cavity and maintaining a seal to the cavity  24  to preclude gas escape from the cavity  24 . Each cannula/trocar has a single channel or passage along its length that allows instruments to be inserted into the body while maintaining the intra-abdominal pressure created by insufflation. Instrument cluster  28  is a single channel instrument cluster which serves to house the laser instrument  34  and direct the laser beam to the operating site. An annular channel  36  around the instrument  34  within the trocar serves as an annular egress passage from near the operating site for gas to be drawn around the laser instrument  34  and out of the patient&#39;s cavity to the smoke clearing device  10  of the present invention. 
       FIG. 2  is a top perspective view of a typical disposable laparoscopic smoke evacuation system  100  (“lapevac  100 ”). Such devices are described in U.S. Pat. No. 6,544,210 to Trudel, et al. which is hereby incorporated by reference in its entirety. Housing  111  is shown with inlet means, in this case inlet tube  112  and outlet means, in this case outlet tube  120  attached to inlet attachment  112   a  and outlet attachment  120   a , respectively. Inserted into the input end of inlet tube  112  is wick assembly  114 . Attached to the outlet attachment  120   a  is the inlet of one embodiment of a multi-outlet relief valve, in this case a two-way bleed or relief valve, t-tap valve  150 . By two-way valve is meant a valve that has at least two outlets that allow material, such as a gas or liquid fluid, that enters the valve to be directed to one of two or more different outlet flow paths. Also seen is y-connector  124  (“connector  124 ”) at the end of outlet tube  120 . Persons of skill in the art will recognize that the two-way valves may be connected to outlet tube  120  in any convenient position within the length of outlet tube  120  and that valves having more than two outlets may also be used. 
       FIG. 3  is an exploded top perspective view of lapevac  100 . Inlet hose  112  is seen attached to inlet attachment  112   a . Inlet assembly  130  includes inlet  131  which covers the fan or pump assembly to include impeller cover  132 , impeller  133 , fan  134 , and fan mount  134   a  which are all attached to motor  136 . Battery cover  111   a  covers battery (ies)  138  used to power motor  136 . Although a plurality of AA batteries are shown in  FIG. 3 , persons of skill in the art will recognize that a single battery, various appropriate battery assemblies with different capacities, or alternative ac power sources may be used to provide power to motor  136 . 
     Outlet  142  covers filter  140  positioned on the downstream side of fan assembly  130 . In the preferred embodiment shown, filter  140  includes activated carbon media  141   a  as a prefilter plus ultra low particulate air (ULPA) filter  141   b . Outlet attachment  120   a  extends from outlet  142  and is seen connected to t-tap valve  150 . One end of outlet tube  120  is connected to t-tap valve  150 , while the other end is connected to connector  124 . A locking means  126  is positioned on at least one outlet of y-connector  124  to enable y-connector  124  to be securely attached to an additional component. In one embodiment, locking means  126  is a luer lock. Cap  127  is used to block an unused outlet of y-connector  124 . In a preferred embodiment, locking means  116 , such as a luer lock, may be positioned at the input end of inlet tube  112  as shown in  FIGS. 2 and 3 . Locking means utilized throughout the invention are defined as connections between two components that prevent the escape of vapor, liquid, or fumes from the connection itself. Examples of locking means are luer locks, tube connections in which one tube is inserted into another tube, interference fittings, Colder couplers and other connectors known to those skilled in the art that prevent the escape of fumes from a connection point. 
     Y-connector  124  receives filtered gas from lapevac  100 . One of the two outlets of y-connector  124  can be connected to an insufflator while the second outlet can be connected to a second inlet into the abdominal cavity enabling gas filtered by lapevac  100  (“filtered gas”) to be pumped into the abdominal cavity at two locations to help remove waste vapors generated by the laparoscopic surgical procedures. 
       FIG. 3A  depicts an enlarged view of wick assembly  114  incorporated into inlet tube  112 . Inlet tube  112  is cut way to more clearly show wick  115 . Luer lock  116  is shown at the inlet end of inlet tube  112 . 
       FIG. 4  is a top perspective view depicting the components of wick assembly  114  joined together in an assembled condition. Luer lock  116  is shown at the inlet end of inlet tube  112 . Interference fitting  117  (“fitting  117 ”) is attached to luer lock  116  and wick  115 . Wick assembly  114  is inserted into inlet tube  112  and held in place by the friction of interference fitting  117  against the inner wall of inlet tube  112 . Wick  115  is in the form of a strand or filament that extends into inlet tube  112 . Preferably, wick  115  is fabricated from a hydrophilic material such as polyvinyl alcohol (PVA) or cotton. Wick  115  is sized with a diameter small enough to allow sufficient space for airway  119  between wick  115  and inner wall of inlet tube  112  to form a passage to allow smoke, air and other fluids to be easily drawn into inlet tube  112  and pass through filter  140  of lapevac  100  to outlet tube  120  in the form of filtered gas. By hydrophilic is meant the property of attracting and to at least some extent absorbing liquids and fluids. 
       FIG. 4A  is a top perspective view of partially disassembled wick assembly  114 . Fitting  117  is attached to luer lock  116  and inserted into inlet tube  112 . Luer lock  116  or other locking means used should be hollow in order to allow the flow of fluid, including vapors and gases, into and through inlet tube  112 . Similarly, fitting  117  should also be hollow to allow for sufficient air flow to move incoming vapor and gas without taxing lapevac  100 . Wick  115  is attached to fitting  117  and the luer lock-fitting-wick assembly is inserted into inlet tube  112 .  FIG. 4B  is a side view of wick assembly  114  showing more clearly fitting  117  and wick  115  within inlet tube  112  and airway  119 . 
       FIG. 5  is a side view of wick  115  fabricated from PVA. In the embodiment shown, wick  115  is about 20 inches long.  FIG. 5A  is an end view of wick  115  in which wick  115  possesses a rectangular cross section with a width of about 0.12 inches and a height of about 0.08 inches.  FIG. 5B  is an isometric view of wick  115 . PVA is one of the preferred materials for fabricating wick  115 . When dry it is rigid hydrophilic foam. In the presence of water or humidity it becomes soft and flexible with good chemical resistance and good water absorption properties. 
     Lapevac  100  is used during laparoscopic surgery to keep the field of view while performing surgical procedures. The inflation creates space within the cavity thereby making it easier to perform surgery. A separate insufflator inflates the abdominal cavity (or other cavity) by pumping air or other gas (es) into the abdominal cavity. To remove surgically generated smoke and other vapors, lapevac  10  removes smoke and other vaporous waste into inlet tube  112  through filter  140  and out outlet tube  120  as filtered gas. The second or downstream end of outlet tube  120  is attached to a hollow channel inserted into the abdominal cavity and to the insufflator by means of connector  124 . Using this system, a recirculating stream of filtered gas or air enters the abdominal cavity as the smoke and waste filled vapors are removed to keep the abdominal cavity under a relatively constant inflation pressure. 
     Although lapevac system  100  is effective in maintaining cavity inflation pressure, one problem that occurs during its operation is the clogging of inlet tube  112  and filter  140  by solid waste, water and humidity carried out of the abdominal cavity by the incoming waste stream. Because the cavity is moist and may be heated above normal temperature by some surgical procedures such as cauterization, surgical wastes can be driven off the cavity wall and internal organs in the form of particles, vapor, and liquids from broken cells and tissues. In addition, vapors within the cavity itself can be drawn into the waste stream. 
     Because it is hydrophilic, wick  115 , attracts and retains the solid moist waste and the aqueous liquid waste that is drawn into inlet tube  112 . Because it is sized to allow for a large airway  119  between the inner wall of inlet tube  112  and wick  115 , relative to the size of wick  115 , wick assembly  114  allows waste stream vapors and gases to move without substantial additional restriction to filter  140 . A preferred length of wick  115  is about 20 inches as this provides sufficient length for exposing the waste stream to the hydrophilic attraction of wick  115 . In addition, the preferred rectangular shape provides more surface area to attract and hold waste particles and vapors than supplied by a round cylindrical shape. 
     It will be recognized that wick assembly  114  is also effective with passive laparoscopic filtration systems. A passive laparoscopic filtration system lacks the fan to actively pull waste vapors from the abdominal cavity, but instead relies on pressure supplied by the insufflator to push surgical waste through an inlet and wick assembly and filters. 
     Another problem that may occur during laparoscopic surgery is the insufficient removal of waste vapor from the cavity and stratification of water vapor in the cavity which can lead to visualization problems for those observing the procedures within the abdominal cavity. This waste vapor can be purged by means of a two-way relief valve  150  placed in the filtered gas outlet path within outlet tube  120 . Relief valve  150  provides the user with the ability to accelerate clearing and/or removal of stratified laparoscopic filtration waste vapor by opening a divert path while blocking the recirculating filtered gas through the normal outlet path back to the cavity. This diversion provides a sudden pressure change by supplying a rapid evacuation capability. 
       FIGS. 6A-D  show t-tap two way valve  150  (“valve  150 ”) configured in the divert mode.  FIG. 6A  is an isometric view of valve  150  showing valve inlet  151 , divert  152 , outlet  153 , and barrel housing  155 .  FIG. 6B  is a top view of valve  150 .  FIG. 6C  is a side view of valve  150  taken from the side facing outlet  153 . It can be seen that in the divert mode, outlet  153  is closed. 
       FIG. 6D  is a cross section of valve  150  taken along line H-H in  FIG. 6B . The arrow shows fluid flow along valve inlet  151  and through divert  152 . Valve barrel  154  (“barrel  154 ”) sits within divert  152  and extends past inlet  151  and outlet  153  into barrel housing  155 . In the divert mode shown, barrel passages  154   a  are positioned below and blocked from the fluid pathway shown by the arrows. Thus, the filtered gas from lapevac  100  is diverted through barrel channel  154   b  and out divert  152  thereby relieving the back pressure situation. 
       FIGS. 7A-D  depict t-tap two-way valve  150  configured in the flow through mode allowing filtered gas to return to the abdominal cavity.  FIG. 7A  is an isometric view of valve  150  showing barrel  154  extending from the top of divert  152 .  FIG. 7B  shows a top view of valve  150  in the open position.  FIG. 7C  is a side view facing the side of outlet  153  in which is seen the pass through channel open to outlet  153 . 
       FIG. 7D  is a cross section of valve  150  taken along line I-I in  FIG. 7B  showing the channel configuration when valve  150  is in the open mode. Barrel  154  is shown extended above the top edge of divert  152 . This places barrel passages  154   a  into channel  151   a  (simultaneous alignment with inlet  151  outlet  153 ) and blocks entrance into divert  152 . Filtered gas then exits through outlet  153  into outlet tube  120  (not shown in  FIG. 7D ) and into the abdominal cavity. 
       FIG. 8A  is a top view of a second embodiment of the two-way divert valve, namely stopcock valve  170  (“valve  170 ”), in the closed or blocking mode. By blocking is meant that no fluid can enter valve  170 .  FIG. 7B  is a side view of valve  170 . Rotor  172  is seen at the junction of inlet  171 , divert  174 , and outlet  173 . Persons of skill in the art will recognize that rotor  172  comprises three fluid flow passages  175  within a housing (not shown) with two passages  175  on opposite sides of rotor  172  and the third passage  175  at right angles between the other two passages. In the closed (no flow) position, the blocked side, lacking a passage  175 , faces inlet  171 . This configuration closes the passage of filtered gas in any direction through valve  70 . In the divert position,  FIG. 8C , the blocked side is rotated to face outlet  173 . In this configuration, filtered gas flows through divert  172 . In the flow through mode,  FIG. 8B , the blocked side is rotated to face divert  172 , forcing the filtered gas to flow through outlet  73 . 
     It is apparent that by positioning a two-way valve, such as valves  150  or  170 , in outlet tube  120 , the effects of back pressure from either the insufflator or unfiltered back flow from the abdominal cavity are reduced or eliminated. Filtered air can be diverted from the recirculating waste/filtered gas system until the visualization within the cavity is brought to acceptable conditions. 
     Thus, it is seen that the objects of the present invention are efficiently obtained, although modifications and changes to the invention should be readily apparent to those having ordinary skill in the art, which modifications are intended to be within the spirit and scope of the invention as claimed.