WO2018039239A1

WO2018039239A1 - Continuous gas supply insufflator having exhaust line peritoneal pressure control methods

Info

Publication number: WO2018039239A1
Application number: PCT/US2017/048031
Authority: WO
Inventors: Wayne L. Poll
Original assignee: Poll Wayne L
Priority date: 2016-08-22
Filing date: 2017-08-22
Publication date: 2018-03-01

Abstract

The present application relates to systems for providing and maintaining pressure in an insufflated surgical operating space such as the peritoneal cavity. In one aspect, there is a smoke evacuation system that operates based on exhaust line pressure measurements and independent of an insufflator circuit. In another aspect, there is an integrated surgical vision and smoke evacuation system that operates based on exhaust line pressure measurements and independent of an insufflator circuit. In still another aspect, there is a smoke evacuation system that operates based on exhaust line pressure measurements under coordinated control of an insufflator circuit. In still another aspect, there is an integrated surgical vision and smoke evacuation system that operates based on exhaust line pressure measurements under coordinated control of an insufflator circuit.

Description

CONTINUOUS GAS SUPPLY INSUFFLATOR HAVING EXHAUST LINE

PERITONEAL PRESSURE CONTROL METHODS

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No.

62/378, 169 filed August 22, 2016, and titled "CONTINUOUS GAS SUPPLY INSUFFLATOR HAVING EXHAUST LINE PERITONEAL PRESSURE CONTROL METHODS," which is herein incorporated by reference in its entirety.

INCORPORATION BY REFERENCE

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

FIELD

[0003] The present application relates to systems for providing and maintaining pressure in an insufflated surgical operating space such as the peritoneal cavity.

BACKGROUND

[0004] Insufflation systems are commonly used to supply insufflation gas into a surgical cavity such as the peritoneal cavity. In general, the pressure monitored in the insufflated field is measured in conjunction with the supply to insufflation gas. As a result, the supply of insufflation gas is commonly interrupted in order to take a measurement of pressure and make adjustments as needed to maintain insufflation set points. The intermittent nature of the supply of insufflation gas and the associated cycling of gas supply and pressure readings has overly complicated the design and use of insufflation systems. What are needed are improved insufflation control schemes to reduce the complexity of insufflation gas supply and pressure control systems.

SUMMARY OF THE DISCLOSURE

[0005] In general, in one embodiment, an exhaust treatment system for use with an insufflated surgical space includes an exhaust treatment system having an exhaust flow inlet port, an exhaust port, a valve that when closed isolates the exhaust flow inlet port from the exhaust port, and a pressure sensor between the valve and the exhaust inlet port. An exhaust treatment system controller has computer readable instructions for operating the valve, obtaining a pressure reading from the pressure sensor and comparing the pressure reading to an insufflated surgical space pressure set point, and operating the valve to remain closed while obtaining a pressure reading and while the pressure reading is below the insufflated surgical space pressure set point.

[0006] This and other embodiment can include one or more of the following features. The exhaust treatment system can further include an exhaust line connected to a second trocar and to the exhaust flow inlet port, and a filter in communication with the exhaust line to filter the exhaust gas flow prior to entry into the exhaust flow inlet port. The filter can be configured to one or more of particles, odors and moisture from the gas flow in the exhaust line. The exhaust treatment system can further include a surgical field vision clearing system outlet port, a surgical field vision clearing system gas flow control valve, and a gas supply line connected to the surgical field vision clearing system outlet port and to a surgical field vision clearing system. The exhaust treatment system controller can further include computer readable instructions for operating the surgical field vision clearing system gas flow control valve to provide a base flow rate to the surgical field vision clearing system and a burst flow rate to the surgical field vision clearing system. The exhaust treatment system can further include a trigger in communication with the exhaust treatment system controller and computer readable instructions to provide the burst flow rate to the surgical field vision clearing system when the trigger is operated. The trigger can be a foot pedal, a push button, a lever or a switch.

[0007] In general, in one embodiment, an insufflator having exhaust pressure sensing feedback includes an insufflation gas inlet port and an insufflation gas outlet port, a surgical field vision clearing system outlet port, an insufflation gas control valve, a surgical field vision clearing system gas flow control valve, an insufflation gas pressure regulator in communication with the insufflation gas inlet and the insufflation gas and surgical field vision clearing system control valves, an exhaust flow inlet port, an exhaust port, and an insufflation pressure controller having computer readable instructions for measuring and exhaust flow pressure from the exhaust flow inlet port, comparing the exhaust flow pressure to an insufflation pressure set point, and adjusting the insufflation gas control valve and the surgical field vision clearing system gas flow control valve in response to the result of the comparing step to control the insufflation pressure in an insufflated surgical space in communication with the insufflator.

[0008] This and other embodiments can include one or more of the following features. The insufflator can further include a first gas supply line connected to a first trocar and to the insufflation gas outlet port, a second gas supply line connected to the surgical field vision clearing system and to the surgical field clearing system outlet port, and an exhaust line connected to a second trocar and to the exhaust flow inlet port, and a filter in communication with the exhaust line to filter the exhaust gas flow prior to entry into the exhaust flow inlet port. The filter can be configured to one or more of particles, odors and moisture from the gas flow in the exhaust line. The insufflator can further include a valve under control of the insufflation pressure controller that when closed stops the flow of gas in the in the exhaust line and a pressure sensor in communication with the insufflation pressure controller. The pressure sensor can be positioned and configured to provide a pressure reading from the exhaust line between the valve and the second trocar. The insufflator can further include computer readable instructions in the insufflation controller to operate the valve to remain closed while the pressure reading in the exhaust line is below an exhaust line set point and to open the valve while the pressure reading in the exhaust line is above an exhaust line set point. The exhaust line set point can correspond to a minimum pressure setting for an insufflated cavity in communication with the second trocar.

[0009] In general, in one embodiment, an insufflator has exhaust pressure sensing feedback including an insufflation gas inlet port and an insufflation gas outlet port, an insufflation gas pressure regulator and an insufflation gas control valve in communication with the insufflation gas inlet and outlet ports, an exhaust flow inlet port, an exhaust port, an insufflation pressure controller having computer readable instructions for measuring and exhaust flow pressure from the exhaust flow inlet port, comparing the exhaust flow pressure to an insufflation pressure set point, and adjusting the insufflation gas control valve in response to the result of the comparing step to control the insufflation pressure in an insufflated surgical space in communication with the insufflator.

[0010] This and other embodiments can include one more of the following features. The insufflator can further include a gas supply line connected to a first trocar and to the insufflation gas outlet port and an exhaust line connected to a second trocar and to the exhaust flow inlet port, and a filter in communication with the exhaust line to filter the exhaust gas flow prior to entry into the exhaust flow inlet port. The filter can be configured to one or more of particles, odors and moisture from the gas flow in the exhaust line. The insufflator can further include a valve under control of the insufflation pressure controller that when closed stops the flow of gas in the in the exhaust line and a pressure sensor in communication with the insufflation pressure controller. The pressure sensor can be positioned and configured to provide a pressure reading from the exhaust line between the valve and the second trocar.

[0011] In general, in one embodiment, a method for maintaining an insufflation gas within an insufflated surgical space includes: (1) providing an insufflation gas to a continuous insufflation gas control system; (2) metering the flow of the insufflation gas delivered through a first trocar into the insufflated surgical space; (3) exhausting a gas from the insufflated surgical space via a second trocar; (4) providing the gas from the exhausting step into the continuous insufflation gas control system; (5) obtaining a pressure measurement of the insufflated surgical space using the gas from the insufflated surgical space; and (6) regulating the flow of the insufflation gas in the providing an insufflation gas step in response to the obtaining a pressure measurement of the insufflated surgical space steps.

[0012] This and other embodiments can include one or more of the following features. The method for maintaining an insufflation gas can further include filtering the gas in the exhausting a gas step to remove at least one of a particle, an odor or a moisture content prior to performing the providing the gas step. The method for maintaining an insufflation gas obtaining a pressure measurement step can further include closing a valve to stop the exhausting a gas step and measuring a pressure in a line in communication with the second trocar. The method for maintaining an insufflation gas can further include continuing the closing a valve step so long as the pressure measurement is below a threshold pressure used to maintain a minimum insufflation pressure in the insufflated surgical space.

[0013] In general, in one embodiment, a method for maintaining an insufflation gas within an insufflated surgical space and operating a surgical field vision clearing system includes: (1 ) providing an insufflation gas to a continuous insufflation gas control system; (2) metering the flow of the insufflation gas delivered through a first trocar into the insufflated surgical space; (3) metering the flow of the insufflation gas delivered into the insufflated surgical space by operation of the surgical field vision clearing system; (4) exhausting a gas from the insufflated surgical space via a second trocar; (5) providing the gas from the exhausting step into the continuous insufflation gas control system; (6) obtaining a pressure measurement of the insufflated surgical space using the gas from the insufflated surgical space; and (7) regulating the flow of the insufflation gas in the metering steps in response to the pressure measurement from the obtaining a pressure measurement step.

[0014] This and other embodiments can include one or more of the following features. The method for maintaining an insufflation gas can further include filtering the gas in the exhausting a gas step to remove at least one of a particle, an odor or a moisture content prior to performing the providing the gas step. The method for maintaining an insufflation gas obtaining a pressure measurement step can further include closing a valve to stop the exhausting a gas step and measuring a pressure in a line in communication with the second trocar. The method for maintaining an insufflation gas can further include continuing the closing a valve step so long as the pressure measurement is below a threshold pressure used to maintain a minimum insufflation pressure in the insufflated surgical space. [0015] In general, in one embodiment, a method of providing smoke evacuation to an insufflated surgical space includes: (1) operating an insufflator to provide an insufflated cavity; (2) delivering a gas at a first flow rate under control of a smoke evacuation system to the insufflated cavity using a first line connected to a medical instrument vision clearing system within the insufflated cavity; (3) removing gas from the insufflated cavity under control of the smoke evacuation system using a second line connected to a trocar in communication with the insufflated cavity; (4) stopping the removing gas from the insufflated cavity step using a valve under control of the smoke evacuation system controller; (5) measuring a pressure in the insufflated cavity using the second line during the stopping the removing gas step; (6) comparing the result of the measure the pressure in the insufflated cavity step to a smoke evacuation set point using the smoke evacuation system controller to determine if the pressure in the insufflated cavity is above or below the smoke evacuation set point; and (7) continuing the stopping the removing gas step if the pressure in the insufflated cavity is below the smoke evacuation setpoint and resuming the removing gas from the insufflated cavity step if the pressure in the insufflated cavity is above the smoke evacuation set point.

[0016] In general, in one embodiment, a method of operating an insufflator having smoke evacuation capabilities includes: (1) delivering a gas under control of an insufflator using a first line in communication with a first trocar in communication with a body cavity to provide an insufflated body cavity at an insufflation pressure; (2) removing gas under control of an insufflator from an insufflated cavity using a second line in a second trocar in communication with the insufflated cavity; (3) stopping the removing gas from the insufflated cavity step using a valve under control of the insufflator controller; (4) measuring a pressure in the insufflated cavity using the second line during the stopping the removing gas step; (5) comparing the result of the measuring the pressure in the insufflated cavity step to a smoke evacuation set point using the insufflator controller to determine if the pressure in the insufflated cavity is above or below a smoke evacuation set point; (6) continuing the stopping the removing gas step if the pressure in the insufflated cavity is below the smoke evacuation setpoint and resuming the removing gas from the insufflated cavity step if the pressure in the insufflated cavity is above the smoke evacuation set point; and (7) performing the delivering a gas under control of the insufflator step during the removing, stopping, measuring, comparing and continuing steps.

[0017] In general, in one embodiment, a method for operating an insufflator having smoke evacuation and vision cleaning system capabilities includes: (1 ) delivering a gas under control of an insufflator using a first line in a first trocar in communication with a body cavity to provide an insufflated body cavity at an insufflation pressure; (2) delivering a gas under control of the insufflator at a first flow rate to the insufflated cavity using a second line connected to a medical instrument vision clearing system in use within the insufflated body cavity; (3) removing gas under control of the insufflator from the insufflated cavity using a third line in a second trocar in communication with the insufflated cavity; (4) stopping the removing gas from the insufflated cavity step using a valve under control of the insufflator controller; (5) measuring a pressure in the insufflated cavity using the third line during the stopping the removing gas step; (6) comparing the result of the measuring the pressure in the insufflated cavity step to a smoke evacuation set point using the insufflator controller to determine if the pressure in the insufflated cavity is above or below a smoke evacuation set point; (7) continuing the stopping the removing gas step if the pressure in the insufflated cavity is below the smoke evacuation setpoint and resuming the removing gas from the insufflated cavity step if the pressure in the insufflated cavity is above the smoke evacuation set point; and (8) performing the step of delivering a gas under control of the insufflator using a first line during the removing, stopping, measuring, comparing and continuing steps.

[0018] In general, in one embodiment, a method of operating a surgical vision and smoke evacuation system during separate operations of an insufflator includes: (1) delivering a gas at a first flow rate under control of a smoke evacuation system to an insufflated cavity using a first line connected to a medical instrument vision clearing system within the insufflated cavity maintained by an insufflator; (2) removing gas from the insufflated cavity under control of the smoke evacuation system using a second line connected to a trocar in communication with the insufflated cavity; (3) stopping the removing gas from the insufflated cavity step using a valve under control of the smoke evacuation system controller; (4) measuring a pressure in the insufflated cavity using the second line during the stopping the removing gas step; (5) comparing the result of the measuring the pressure in the insufflated cavity step to a smoke evacuation set point using the smoke evacuation system controller to determine if the pressure in the insufflated cavity is above or below the smoke evacuation set point; and (6) continuing the stopping the removing gas step if the pressure in the insufflated cavity is below the smoke evacuation setpoint and resuming the removing gas from the insufflated cavity step if the pressure in the insufflated cavity is above the smoke evacuation set point.

[0019] In general, in one embodiment, a method for operating a smoke evacuation and vision clearing system includes: (1) delivering gas at a base flow rate under control of a smoke evacuation system to an insufflated cavity using a first line connected to a medical instrument vision clearing system within the insufflated cavity; (2) removing gas under control of the smoke evacuation system from the insufflated cavity using a second line connected to a trocar in communication with the insufflated cavity; (3) stopping the removing gas from the insufflated cavity step using a valve under control of the smoke evacuation system controller; (4) measuring a pressure in the insufflated cavity using the second line during the stopping the removing gas step; (5) comparing the result of the measuring the pressure in the insufflated cavity step to a smoke evacuation set point using the smoke evacuation system controller to determine if the pressure in the insufflated cavity is above or below the smoke evacuation set point; (6) continuing the stopping the removing gas step if the pressure in the insufflated cavity is below the smoke evacuation setpoint and resuming the removing gas from the insufflated cavity step if the pressure in the insufflated cavity is above the smoke evacuation set point; (7) dispensing a lens clearing solution to the medical instrument vision clearing system while in use within the insufflated cavity; (8) delivering a gas under control of the smoke evacuation system at a burst flow rate to the first line connected to the medical instrument vision clearing system to assist in removal of the lens clearing solution and thereafter resume the step of delivering gas at the base flow rate.

[0020] These and other embodiments can include one or more of the following features. The stopping step, the measuring step, and the comparing steps can be performed more than once a second. The stopping step, the measuring step, and the comparing steps can be performed at least once every two seconds. A subsequent sequence of performing the stopping step, the measuring step, and the comparing steps can be performed within five seconds of the immediately prior performance of the stopping, measuring and comparing steps.

[0021] In general, in one embodiment, a method of controlling pressure in an insufflated surgical cavity includes: (1) supplying an insufflation gas to an insufflator; (2) insufflating a surgical cavity by flowing in insufflation gas from the insufflator through a first trocar into the surgical cavity; (3) exhausting a gas from within the insufflated surgical cavity through a second trocar; (4) providing the gas from the exhausting step to the insufflator; and (5) adjusting the insufflating a surgical cavity step by adjusting the flow rate of the insufflation gas to the first trocar based on a measured pressure of the gas from the exhausting step.

[0022] This and other embodiments can include one or more of the following features. The method can further include filtering the gas from the exhausting step to remove moisture or particles before the providing step. The method can further include stopping the exhausting a gas step and measuring a pressure of the surgical cavity using a line connected to the second trocar. The method can further include stopping the exhausting a gas step by closing a valve and measuring the pressure in the surgical cavity while the valve is closed.

[0023] In general, in one embodiment, a method of controlling pressure in an insufflated surgical cavity includes: (1) supplying and insufflation gas to an insufflator; (2) insufflating a surgical cavity by flowing in insufflation gas from the insufflator through a first trocar into the surgical cavity; (3) exhausting a gas from within the insufflated surgical cavity through a second trocar; (4) measuring the pressure of the gas from the exhausting step; and (5) adjusting the insufflating a surgical cavity step by adjusting the flow rate of the insufflation gas to the first trocar based on the measuring the pressure of the gas from the exhausting step.

[0024] This and other embodiments can include one or more of the following features. The method can further include filtering the gas from the exhausting step to remove moisture or particles before the measuring step. The method can further include stopping the exhausting a gas step while performing the measuring the pressure step. The method can further include closing a valve to stop the exhausting a gas step and measuring the pressure in the surgical cavity while the valve is closed. The method can further include stopping the exhausting a gas step and measuring the pressure of the surgical cavity using a line connected to the second trocar. The method can further include stopping the exhausting a gas step by closing a valve and measuring the pressure in the line while the valve is closed.

BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative

embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

[0026] FIG. 1 illustrates an embodiment of an insufflation supply system with continuous exhaust flow pressure sensing feedback connected to a supply of insufflation gas and to a first and a second trocar in communication with an insufflated surgical space. An insufflation gas outlet is connected to the first trocar for use in conjunction with a laparoscope. An exhaust flow inlet port is connected to a second trocar.

[0027] FIG. 2 is a schematic drawing of the internal workings of the insufflator of FIG. 1 showing the relationships between the insufflation gas inlet port, the insufflation gas pressure regulator, the insufflation gas control valve, insufflation gas outlet port, exhaust flow inlet port, exhaust flow control valve, exhaust flow pressure sensor and the insufflator pressure controller. The view of FIG. 2 also shows an optional location for an exhaust pump and optional use of one or more gas conditioning, gas filtration or recirculation systems. In the illustrated example, the pump is provided schematically at the insufflator exhaust port in communication with the pressure sensor. Other locations are possible depending upon system configuration and other factors.

[0028] FIG. 3 is a schematic drawing of the internal workings of an insufflator similar to that of FIG. 2 showing the relationships between the insufflation gas inlet port, the insufflation gas pressure regulator, the insufflation gas control valve, insufflation gas outlet port, exhaust flow inlet port, exhaust flow control valve, exhaust flow pressure sensor and the insufflator pressure controller. The view of FIG. 3 also shows an optional location for an exhaust pump and optional use of one or more gas conditioning, gas filtration or recirculation systems. In the illustrated example, the pump is provided schematically at the insufflator exhaust port in communication with the pressure sensor. Other locations are possible depending upon system configuration and other factors.

[0029] FIG. 4 is a illustrates an embodiment of an insufflation supply system with continuous exhaust flow pressure sensing feedback connected to a supply of insufflation gas and to a first and a second trocar in communication with an insufflated surgical space as in FIG. 1. An insufflation gas outlet is connected to the first trocar for use in conjunction with a laparoscope as well as additional connection to supply gas to a surgical vision clearing system used in conjunction with the laparoscope. An exhaust flow inlet port is connected to a second trocar.

[0030] FIG. 5 is a schematic drawing of the internal workings of the insufflator of FIG. 4 that is similar to that of FIG. 2 and also includes an additional insufflation supply control valve and an outlet port for connection to the vision clearing system of FIG. 4.

[0031] FIG. 6 is a perspective view of a trocar having a pressure sensor for providing exhaust pressure measurements to the insufflator.

[0032] FIG. 7 is a kit having one or more trocars configured for use with the insufflator to provide information regarding the insufflated surgical cavity to the insufflator including one or more sensors on, in or within a trocar positioned to obtain data related to the insufflated surgical space.

[0033] FIG. 8 illustrates an embodiment of an insufflation supply system with continuous exhaust flow pressure sensing feedback connected to a supply of insufflation gas and to a first and a second trocar in communication with an insufflated surgical space as in FIG. 4. An insufflation gas outlet is connected to the first trocar for use in conjunction with a laparoscope as well as additional connections to supply gas to a surgical vision clearing system used in conjunction with the laparoscope with additional flow clearance aids such as an injectable surfactant and an air burst bulb.

[0034] FIG. 9 illustrates an alternative embodiment of a configuration of an insufflation supply system with continuous exhaust flow pressure sensing feedback connected to a supply of insufflation gas and to a first and a second trocar in communication with an insufflated surgical space as in FIG. 8. An insufflation gas outlet is connected to the first trocar for use in conjunction with a laparoscope as well as additional connections to supply gas to a surgical vision clearing system used in conjunction with the laparoscope with additional flow clearance aids such as an injectable surfactant and an air burst bulb. This view also shows a modified trocar for providing exhaust flow readings or data to the insufflator with continuous exhaust flow pressure sensing.

[0035] FIG. 1 OA is a front view of a computer controlled smoke evacuation system to remove gas from an insufflated cavity and provide insufflated cavity pressure readings.

[0036] FIG. 10B is a front view of a FloShield vision protection system for computer- controlled operations to supply pressurized gas to a FloShield device and evacuate gas from an insufflated surgical cavity via the illustrated gas line connections.

[0037] FIG. 1 1 is a perspective view of a laparoscope view optimizer having front air flow capabilities.

[0038] FIG. 12 is a perspective view of another laparoscope view optimizer having burst air flow capabilities.

[0039] FIG. 13 is an exploded view of the laparoscope view optimizer of FIG. 12.

[0040] FIG. 14 is a section view of an in line filter for use with a smoke evacuation line described herein.

[0041] FIG. 15 is a front view of three filters that may be in interchangeably ganged together and used with a smoke evacuation line described herein.

[0042] FIG. 16 shows a filter connected to a trocar and exhaust gas line.

[0043] FIG. 17 shows a pair of filters for particles or gas removal or optionally a particle filter and a moisture trap or filter connected to a trocar and exhaust gas line.

[0044] FIG. 18 is a flow chart of exemplary steps for independent operation of a smoke evacuation system during operation of an insufflator to maintain an insufflated cavity.

[0045] FIG. 19 is a flow chart of exemplary steps for operation of an insufflator having smoke evacuation capabilities.

[0046] FIG. 20 is a flow chart of exemplary steps for operation of an insufflator having smoke evacuation and vision cleaning system capabilities.

[0047] FIG. 21 is a flow chart of exemplary steps for integrated operation of a smoke vision clearing and smoke evacuation system during separate operations of an insufflator.

[0048] FIG. 22 is a flow chart of an exemplary smoke evacuation and vision clearing system as in FIG. 21 including an additional step of a burst mode operation.

DETAILED DESCRIPTION

[0049] In one exemplary embodiment, the inventive insufflator supplies gas to a first trocar port through a tube connected to an insufflator supply port. The volume of gas is provided by a continuously flowing insufflation supply. In this aspect, continuously flowing insufflation supply differs from traditional nearly continuous insufflation supply. The conventional systems are considered nearly continuous because of interruptions in supply of insufflation gas to measure insufflation pressure.

[0050] In contrast, embodiments and various configurations of the inventive insufflation system with continuous exhaust flow pressure sensing monitors and measures the pressure in an insufflated surgical space in an exhaust line of the insufflated space. Put another way, the pressure readings used to control the flow of insufflation gases and/or to maintain the insufflated space at a pressure set point do not rely on any line or pressure reading in any line related to the supply of insufflation gas. Advantageously, during use of embodiments of the inventive insufflation supply system, the supply of insufflation gas is not interrupted to measure insufflation pressure as in done in conventional insufflation systems.

[0051] The advantageous use of an exhaust gas flowing from an insufflated surgical cavity is in contrast to existing insufflation systems where insufflation pressure readings are performed through discontinuous flow through the insufflation supply lines, which pauses to measure pressure before resuming flow, or by a separate standalone static pressure measuring line, whose measurement affects the gas supply of the insufflation line. In one aspect, embodiments of the exhaust flow insufflator are configured so that a smoke evacuation exhaust line serves as the pressure monitoring line, and is provided to an insufflator with a computer flow control system having modified operational characteristics to adjust insufflation gas flows, exhaust flow and insufflation pressure set point such that the exhaust pressure measurement affects insufflator flow to the patient. In some alternative configurations, the insufflator may pause the exhaust line flow intermittently, in a programmed fashion such as with a suitable isolation valve, to measure an exhaust line static pressure, before resuming flow. In this fashion, when an exhaust line static pressure is used, there is intermittency of the exhaust line, not the insufflation line, allowing for higher and continuous gas flow in the insufflation supply lines, if desired.

[0052] As a result, embodiments of the inventive insufflator pressure control system may use a continuous or nearly continuous exhaust flow rate measuring technique to determine peritoneal pressure. The peritoneal pressure reading - obtained from either technique based on insufflator configuration - is then used as a peritoneal pressure feedback signal to adjust the insufflation gas supply flow rate from the continuously flowing insufflator to trocar 1 and into the peritoneal cavity.

[0053] Alternatively, in still another specific configuration, the insufflator pressure control system may use a nearly continuous pressure reading from the exhaust line to determine peritoneal pressure. In the case of a nearly continuous pressure reading, the exhaust line flow is briefly interrupted to permit pressure readings to be taken. By way of illustration, the exhaust flow is interrupted for only a few seconds, only a second or for fractions of a second depending upon the responsiveness of the pressure sensor in use. The pressure sensor may be within the insufflator, in the exhaust line connected to the trocar or in the trocar itself. Regardless of configuration, the exhaust gas pressure is provided to the insufflator computer controller. In one embodiment, the term "nearly continuous" is appropriate since the exhaust flow is interrupted for such a brief period. Thereafter, the insufflator controller uses the measured pressure to adjust the flow rate supplied to first trocar port to maintain a target peritoneal pressure.

[0054] In summary, described herein are embodiments of exhaust pressure monitoring in a smoke/evacuation/exhaust line using either continuous measurements or, with the use of a suitable isolation valve, a static exhaust pressure measurement.

[0055] Additionally or optionally if a static exhaust pressure measurement is desired or deemed more responsive to changes in insufflation pressure using the exhaust flow technique described herein, then, the exhaust/smoke/evacuation line could simply stop flowing, or occlude, on the side of the tubing distal to the pressure sensor, very briefly, to record or transmit pressure to the insufflator controller and then start flowing again. In this configuration, the pressure sensor takes a reading of the pressure in the insufflated cavity via a line used for a smoke evacuation system. The gas in the line may be filtered to remove odor, particles, debris and moisture prior to measurement and/or exhaust into the OR and/or recirculation for use as a supply gas to an insufflator or to a surgical vision clearance system.

[0056] As a result, such a rapid temporary occlusion to record pressure every second or so to record pressure and then to keep exhaust flowing as an "almost" continuous smoke evacuation flow. In one embodiment, computer readable instructions provide for operations of the pressure sensor isolation valve to close, obtain readings from the pressure sensor and then open. The cycle of closing the isolation valve and taking a reading can be repeated at an interval of fractions of a second, every second, every two, three or four seconds depending on the desired frequency of pressure sampling desired and the response time of the isolation valve and pressure sensor as some time lag may occur to allow for isolation valve operation and pressure readings. In one embodiment, no more than five seconds passes before another pressure reading is obtained.

[0057] In one embodiment, an exhaust line is connected to a trocar in communication with the insufflated space and also connected to the insufflator exhaust inlet port. In this way exhaust gas taken from the peritoneal cavity is supplied to the insufflator. The insufflator then determines peritoneal pressure using the peritoneal exhaust gas obtained from the exhaust line trocar. In this way, the insufflator control system uses an insufflated surgical field exhaust flow - such as an exhaust flow from an insufflated peritoneal exhaust gas to - to determine the volume of gas to supply into the peritoneal space to maintain a target peritoneal pressure set point. In the process of obtaining an insufflated surgical field pressure measurement using the exhaust gas flow, the insufflated surgical field exhaust gas may optionally flow through a filter cartridge, or other treatment system or simply be provided to the exhaust inlet port and, thereafter, be exhausted into the operating room or other suitable disposal or recirculation system via the pump. As alternatives, the pressure in the exhaust line is measured after the filter which then exhausts gas into the room. In another alternative, there is not an exhaust filter, and the measured exhaust gas either exhausts into the room after pressure is measured, or the gas might simply flow into the suction system in the operating room, with or without a filter.

[0058] Through either and all such methods, there is an exhaust line which connects to a trocar in communication with an insufflated surgical space and removes gas from the abdominal cavity and provides that gas to an exhaust inlet port in the insufflator or a smoke evacuation system or for other various purposes. This exhaust gas line is dual purposed in that it is conventionally used as the insufflated space exhaust line but also purposed to measure intraabdominal pressure of the insufflated surgical space. The resulting exhaust line pressure readings are thereafter used in a control system to adjust the supply of the insufflation gas (such as C02, for example) into the patient, done through a separate insufflation outlet port and one or more supply lines depending upon configuration, such as with use of trocar 1 alone or in conjunction with a surgical vision clearing system (i.e., a FloShield system as shown in FIGs. 4 and 5).

[0059] FIG. 1 illustrates an embodiment of an insufflation supply system with continuous exhaust flow pressure sensing feedback connected to a supply of insufflation gas and to a first and a second trocar in communication with an insufflated surgical space. An insufflation gas outlet is connected to the first trocar for use in conjunction with a laparoscope. An exhaust flow inlet port is connected to a second trocar.

[0060] In this configuration, the stand alone insufflator that has only two lines connected to the insufflated surgical space. The gas supply tubing or line one is the insufflator supply line that inflates the patient via trocar 1. The return tubing or exhaust line or line two is the combination pressure sensing/smoke exhaust line connected to trocar 2. Pressure sensing and smoke evacuation line draws air from the insufflated surgical field, via trocar 2, including smoke, debris, particles, toxins and the like occurring in the surgical space. A filter may be provided on this line, see FIGs. 14-17.

[0061] FIG. 2 is a schematic drawing of the internal workings of the insufflator of FIG. 1 showing the relationships between the insufflation gas inlet port, the insufflation gas pressure regulator, the insufflation gas control valve, insufflation gas outlet port, exhaust flow inlet port, exhaust flow control valve, exhaust flow pressure sensor and the insufflator pressure controller. The view of FIG. 2 also shows an optional location for an exhaust pump and optional use of one or more gas conditioning, gas filtration or recirculation systems. In the illustrated example, the pump is provided schematically at the insufflator exhaust port in communication with the pressure sensor. Other locations are possible depending upon system configuration and other factors.

[0062] FIG. 2 shows the basic inputs, outputs and control circuit of the insufflator pressure controller for monitoring peritoneum pressure using the exhausting flow rate. The insufflator pressure controller monitors the exhausting flow rate and controls the insufflation gas control valve (valve 1) to supply gas to the peritoneum through the 1 st trocar port. The exhaust flow control valve (valve 2) is used to control the flow of exhaust gas for safety purposes and balancing the supply and exhausting flow rates to maintain insufflation pressure within desired limits. In an optional configuration, a pressure sensor is provided between valve 2 and trocar 2.

[0063] FIG. 3 is a schematic drawing of the internal workings of an insufflator similar to that of FIG. 2 showing the relationships between the insufflation gas inlet port, the insufflation gas pressure regulator, the insufflation gas control valve, insufflation gas outlet port, exhaust flow inlet port, exhaust flow control valve, exhaust flow pressure sensor and the insufflator pressure controller. The view of FIG. 3 also shows an optional location for an exhaust pump and optional use of one or more gas conditioning, gas filtration or recirculation systems. In the illustrated example, the pump is provided schematically at the insufflator exhaust port in communication with the pressure sensor. Other locations are possible depending upon system configuration and other factors.

[0064] FIG. 3 is an example of an exhaust pressure controller using a pressure isolation valve to operate in a static pressure control mode. FIG. 3 illustrates a configuration where the exhaust gas line connected to trocar 2 can be momentarily interrupted - closing the normally open pressure isolation valve - permitting the pressure sensor to take a reading. Thereafter, the isolation valve is open, gas continues to exhaust from trocar 2 through the exhaust flow rate control valve (valve 2) and exhaust through the filtration cartridge.

[0065] FIG. 3 shows the basic control circuit for monitoring peritoneum pressure by momentarily interrupting the exhaust gas flow from trocar 2 using the pressure isolation valve and taking a reading with the exhaust line pressure sensor. Once the pressure reading is obtained, the isolation valve opens and exhaust flow continues to the filtered exhaust under flow rate control by exhaust flow control valve (valve 2). The insufflator pressure controller monitors the pressure in the exhaust line and controls insufflation gas supple valve (valve 1) to supply gas to the peritoneum through the first trocar port. Valve 2 is used to control the flow of exhaust gas for safety purposes and balancing the supply and exhausting flow rates to maintain constant pressure.

[0066] FIG. 4 is a illustrates an embodiment of an insufflation supply system with continuous exhaust flow pressure sensing feedback connected to a supply of insufflation gas and to a first and a second trocar in communication with an insufflated surgical space as in FIG. 1. An insufflation gas outlet is connected to the first trocar for use in conjunction with a laparoscope as well as additional connection to supply gas to a surgical vision clearing system used in conjunction with the laparoscope. An exhaust flow inlet port is connected to a second trocar as described herein.

[0067] In another aspect, as shown in Fig. 4, the insufflator supplies continuous insufflation gas to the peritoneal cavity via a combination of flow through a FloShield sheath as well as trocar 1. FloShield is a gas flow based surgical field vision clearing system commercially available from Minimally Invasive Systems, Inc., the assignee of the present application. In this application, a FloShield device is synonymous with a gas flow based surgical field vision clearing system. In this configuration, the insufflator will apportion the supply of peritoneal gas between the FloShield Sheath and trocar 1 depending upon the pressure readings obtained from the peritoneal space. In one aspect, the FloShield sheath is the primary gas supply path to the peritoneum, supplying 3 - 12 LPM continuously to the peritoneum, while the trocar port 1 will be used to rapidly supply gas for large changes in peritoneum pressure or large continuous leaks in gas from the peritoneum.

[0068] In another aspect, there may be two insufflator lines, one supplying gas to a trocar, and the other directly to FloShield. The FloShield line may flow gas continuously, and without interruption, while the flow of gas in the insufflation line is affected by, and is turned on and off by, and is adjusted, relative to the pressure of gas in the abdominal cavity, as determined from the exhaust line. Still further, the exhaust line pressure may be monitored via trocar 2 as described above to adjust smoke evacuation operations in concert with maintaining pressure within the insufflated surgical field.

[0069] The insufflator will supply gas to FloShield sheath and to trocar port 1 through two tubes connected to the insufflator supply ports. A second trocar port will be connected to the insufflator for determining peritoneal pressure. Using that pressure reading as feedback, the insufflator control algorithm adjusts the insufflator supply flow rate using the techniques described above to maintain a target peritoneal pressure. [0070] FIG. 5 is a schematic drawing of the internal workings of the insufflator of FIG. 4 that is similar to that of FIG. 3 and also includes an additional insufflation supply control valve and an outlet port for connection to the vision clearing system of FIG. 4.

[0071] FIG. 5 is another configuration for the exhaust flow insufflator to be used with FloShield such that there is specific control of insufflation gas provided to the insufflated surgical field by some combination of FloShield and trocar 1 supply.

[0072] This schematic shows the basic feedback and control circuit of the insufflator pressure controller for monitoring peritoneum pressure using exhaust pressure. The controller monitors the exhausting pressure and controls insufflation supply and Floshield supply valves (valves 1 & 2) to supply insufflation gas to the periioneum through FloShield and the first trocar port. Exhaust pressure control valve (valve 3) is used to control the flow of exhaust gas for safety purposes and balancing the supply and exhaust flow rates to maintain pressure within the insufflated surgical space. The view of FIG. 5 also shows an optional location for an exhaust pump and optional use of one or more gas conditioning, gas filtration or recirculation systems. In the illustrated example, the pump is provided schematically at the insufflator exhaust port in communication with the pressure sensor. Other locations are possible depending upon system configuration and other factors.

[0073] FIG. 6 is a perspective view of a trocar having a pressure sensor for providing exhaust pressure measurements to the insufflator. An exhaust line alone or in combination with a pressure indication and/or an exhaust line connected and data (i.e., sensor output) for pressure reading and other sensor or data information may also be in communication with an utilized by appropriate computer readable instructions in the computer controller of any of the various insufflation, exhaust and surgical vision systems described herein.

[0074] The master controller 34 which may be part of an insufflator controller communicates with an array of sensors 36 that monitor different environmental conditions within the operative space. The nature and type of sensors 36 can vary according to the desired control functions of the master controller 34. For example, as FIG. 6 shows, sensors 36 can be provided that communicate with the operative space to sense (i) C02 insufflation airflow velocity entering the operative space; (ii) C02 pressure within the operative space; (iii) aspiration airflow velocity, (iv) mean absolute humidity levels in the operative space; (v) temperature in the operative space; (vi) density of smoke, particulates, aerosolized pathogens, chemical toxins, and other undesired agents in the operative space; (vii) odors in the operative space; (viii) sound in the operative space (e.g., operation of a harmonic scalpel); and/or (ix) other intra-abdominal environmental atmospheric conditions in the operative space. Sensors can also be provided to monitor the optical clarity of the image received through the laparoscopic lens. Optionally, sensors 36 can also be provided to monitor optical clarity of the laparoscopic image and/or external

environmental atmospheric conditions in the sterile field and/or OR. The trocar 12 may include one or more sensors 13 in an exhaust port, aperture or other connection port.

[0075] The sensor outputs can be generated at specified intervals of time, which need not be the same time interval for each sensor. For example, the C02 insufflation airflow velocity can be sensed at shorter time period than, e.g., temperature in the operative space.

[0076] The periodic sensor outputs are inputted to the master controller. The output of the array of sensors can be bundled in a single sensing cable 50 (see FIG. 6) that is coupled to the master controller 34 within the air management control console 32. The outputs of intra- abdominal sensors can be passed through a single sensor trocar 12 on the operating field, as FIG. 6 shows.

[0077] The master controller 34 processes the inputs according to preprogrammed rules (and caregiver inputs) to derive closed loop control commands for the array of airflow devices having different functions affecting the environmental conditions within the operative space. The preprogrammed rules of the master controller 34 can, e.g., compare the sensed output to specified upper and lower thresholds, and generate control commands that vary a given operating condition to maintain the sensed conditions within the range bounded by the thresholds. The preprogrammed rules of the master controller 34 can also compare one sensed condition to another sensed condition, and to generate control commands that are coordinated to maintain a prescribed balance among different sensed conditions. For example, the master controller 34 can employ a logic table that can dictate a selection of a corrective action according to a

preprogrammed rule IF X AND Y THEN Z: e.g., IF the sensed insufflation C02 pressure is above the minimum threshold (X) and the sensed density of smoke in the operative space is above the targeted maximum threshold (Y), THEN increase the aspiration airflow velocity (Z). In this example, if the sensed insufflation C02 pressure was not above the desired threshold (X), the aspiration airflow velocity would not be increased, as it could lead to a collapse of pneumoperitoneum within the operative space. This is one example of how the master controller 34 can not only control, but also coordinate the processing of multiple independent and sometimes mutually conflicting variables affecting the intra-abdominal operative field.

[0078] The preprogrammed rules can provide control commands that are proportional to sensed absolute deviations from control threshold(s). Alternatively, the preprogrammed rules can provide integral or derivative control commands that are based upon the changes in the deviations over time (increasing? or decreasing?) as well as the rate of the changes in the deviations (i.e., by sensing whether the deviations are getting larger or smaller over time and by how much). The preprogrammed rules of the master controller 34 can also compare the changes over time in one sensed condition to the changes in time to another sensed condition, and to generate proportional, integral or derivative control commands that are coordinated to maintain a prescribed balance among the different sensed conditions, as before described in relation to the

IF X AND Y THEN Z logic rule. Other logic rules can be applied: e.g., IF X OR Y THEN Z, or IF X AND NOT Y THEN Z.

[0079] In this way, the control commands generated by the preprogrammed rules of the master controller 34 can integrate and coordinate a host of airflow control functions, such as insufflation control (e.g., C02 pressure and/or C02 velocity), suction control (e.g., pressure, and/or velocity, and/or clarity/content of aspirated airflow and/or operation of cutting instruments), humidification control (e.g., mean absolute humidity and/or temperature), image clarity control (e.g., airflow velocity to the view optimizing assembly, and/or visual clarity of the image through the laparoscopic lens), air quality control of the operating field and/or the OR, and/or other environmental management control internal and external to the operative space.

[0080] The air management control console 32 as described is an intelligent system that manages all aspects of airflow, suction, humidity, temperature, clarity, and intra-abdominal environmental gas conditions. The air management control console 32 connects to the operative space through sterile tubing. The master controller 34 receives input from an array of sensors present in the operative space or in the OR. The master controller 34 executes pre-programmed rules to balance and optimize the sometimes conflicting effects and capabilities of different airflow devices.

[0081] For example, by sensing continuously pressure, humidity, sound, and particulate matter in the operative space, (i) surgical suction (aspiration) can be governed relative to intraabdominal pressure so that suction cannot empty the cavity; (ii) C02 air flow can be cycled continuously in a metered way to remove particulate matter and smoke; (iii) humidity and/or temperature can be managed in real time to maintain relative humidity and/or temperature above a set point; (iv) supply tubing and connectors can be optimized to deliver truly high flow insufflation; (vi) dry air can be placed over the lens through an add-on accessory

(FloShield.RTM., Minimally Invasive Devices, Inc.) in a continuous fashion; and (vii) sound monitoring can increase gas flow in response to the operation of a harmonic scalpel.

[0082] Additional details are provided in U.S. Patent Application No. 13/185,771, filed July 19, 201 1 , now U.S. Patent Application Publication No. 2012/0184897, incorporated herein by reference. While not limited to the embodiment of FIG. 6, a trocar used to supply the exhaust gas as used herein, may also be provided with a filter to condition the exhaust gas before the exhaust gas stream enters the insufflator gas inlet port. The rules and computer controller features described above for mater controller 34 above may also be incorporated into the computer controller of the various embodiments of insufflation, evacuation, and vision clearance system embodiments described herein.

[0083] In addition or optionally, a suitable exhaust gas filter may be provided in the exhaust gas line between the trocar 2 and the exhaust gas inlet port or at the port itself or within the insufflator. In still other additional aspects, a combined filter and pressure sensor may be provided in a trocar 2 adapted for this purpose. Additional details of smoke evacuation systems and filters are provided in U.S. Patent 7,819,957 and suitable surgical smoke and particle filter systems are commercially available and may be used in the system.

[0084] FIG. 7 is a kit having one or more trocars configured for use with the insufflator to provide information regarding the insufflated surgical cavity to the insufflator including one or more sensors on, in or within a trocar positioned to obtain data related to the insufflated surgical space.

[0085] FIG. 7 shows a simplified system 20 for performing an endoscopic surgical procedure. The system 20 is particularly well suited for use in a situation in which it is desirable to make use of a specialized endoscopic instrument, which provides one or more desirable functional benefits, but which possesses a marginally increased exterior diameter that falls between the cannula sizes used by conventional LT's. For example, and as will be described by example in greater detail later, a given specialized endoscopic instrument having desirable features may require a 7-8 mm access site, which is too large to fit a conventional 5 mm LT, and small enough to not require a conventional 10 mm LT. In the hierarchy of cannula sizes for conventional LT's, cannulas suitable for a 7-8 mm instrument are available but are not uniformly stocked by hospitals, and when they are, they require their own dedicated obturators. The system 20 solves this problem by providing a non-conventional cannula unit 22 to accommodate a marginally larger endoscopic instrument (e.g., 7 to 8 mm), which can be installed using a single smaller diameter conventional LT (e.g., 5 mm), which is then used at another puncture site once the marginally larger cannula unit 22 has been set and the smaller LT withdrawn. The system's solution also makes possible the installation of multiple non-conventional cannula units 22 using a single conventional functional obturator. The result is significantly less medical waste, as well as lowered health care equipment costs.

[0086] More particularly, the system 20 includes a plurality of individual endoscopic cannula units 22 as will be described in greater detail later. The cannula units 22 provide an array of access sites for minimally invasive endoscopic access to and/or visualization of a targeted internal operating field. As shown in FIG. 7, there is no functional obturator preassembled to any cannula unit 22 to aid insertion of the cannula unit into tissue. Each cannula unit 22 is supplied obturator- free. [0087] The system 20 also include a single trocar assembly 24. The trocar assembly 24 includes a single endoscopic cannula 26, which provides one additional site for endoscopic access to the operating field. The trocar assembly 24 also includes, for the cannula 26, a single dedicated functional obturator 28 to aid insertion of the trocar assembly 24 as a unit into tissue. The single dedicated functional obturator 28 of the trocar assembly is the only functional obturator the system 20 provides.

[0088] Additional details are provided in U.S. Patent Application No. 13/31 1 ,085, filed December 5, 201 1 , now U.S. Patent Application Publication No. 2012/0310147, incorporated herein by reference.

[0089] FIG. 8 illustrates an embodiment of an insufflation supply system with continuous exhaust flow pressure sensing feedback connected to a supply of insufflation gas and to a first and a second trocar in communication with an insufflated surgical space as in FIG. 4. An insufflation gas outlet is connected to the first trocar for use in conjunction with a laparoscope as well as additional connections to supply gas to a surgical vision clearing system used in conjunction with the laparoscope with additional flow clearance aids such as an injectable surfactant and an air burst bulb.

[0090] FIG. 8 shows the set up of the view optimizing assembly 1 10 with the system 20 comprising multiple access sites.

[0091] The method makes use of a single 5 mm endoscopic trocar assembly 24 and one or more marginally enlarged endoscopic cannula units 22. Each cannula unit 22 has an interior diameter sized and configured to smoothly and tightly accommodate passage of the 5 mm endoscopic cannula 26, which forms the exterior of the single trocar assembly 24. As a consequence, the exterior diameter of each cannula unit 22 is marginally increased.

[0092] The method selects a single one of the cannula units for inserting into tissue. The method fits the selected cannula unit 22 over the entire single trocar assembly 24 to form a concentric access assembly 56, and manipulates the concentric access assembly 56 as an integrated unit into tissue. At this stage in the procedure, an insufflation line can be connected to the stopcock 18 provided on the trocar assembly 24, to pressurize the operating cavity.

[0093] After body penetration and insufflation have been accomplished, the trocar assembly 24 is withdrawn from the cannula unit 22, leaving the cannula unit 22 in place, providing access to the operating cavity. The gas seal assembly 36 in the cannula unit 22, as above described, prevents loss of insufflation pressure as the method progresses.

[0094] The method optionally includes the repeated reuse of the single trocar assembly 24 to install any desired number of selected cannula units 22, thereby providing any desired number of abdominal penetrations. In the illustrated embodiment of FIG. 8, two cannula units 22 are installed. One of these cannula units 22 will ultimately accommodate passage of the sheath as part of a surgical vision clearance system while another trocar may be connected to an exhaust line for use in an exhaust line pressure control technique described herein.

[0095] After insertion of all desired cannula units 22, the trocar assembly 24 is itself inserted in a traditional manner, to form yet another access site. As shown in FIG. 8, the dedicated functional obturator 28 of the trocar assembly 24 is withdrawn from the endoscopic cannula 26 of the trocar assembly 24, leaving the endoscopic cannula 26 of the trocar assembly 24 in place providing additional access to the operating cavity as well as a site to couple an insufflation pressure line (i.e., to stopcock 18). The entire system 20 shown in FIG. 8 has been installed using but one functional obturator, which can later be discarded as medical waste, or reprocessed.

[0096] As FIG. 8 shows, the tubing set 1 16 of the assembly 10 couples the insufflation circuit to the stopcock 18 of the cannula 26. The laparoscope 1 12 is inserted into the sheath 1 14, and the sheath 1 14 and laparoscope 1 12 are inserted as a unit through one of the installed cannula units 22 as part of a FloShield surgical vision clearance system.

[0097] Additional details are available in above reference U.S. Patent Application No.

13/31 1 ,085, filed December 5, 201 1 , now U.S. Patent Application Publication No.

2012/0310147, incorporated herein by reference.

[0098] FIG. 9 illustrates an alternative embodiment of a configuration of an insufflation supply system with continuous exhaust flow pressure sensing feedback connected to a supply of insufflation gas and to a first and a second trocar in communication with an insufflated surgical space as in FIG. 8.

[0099] FIGS. 9 shows an embodiment of a view optimizing assembly 10 for use in association with a state of the art laparoscope 12. The laparoscope 12 possesses at 0° (blunt) shaft tip. The laparoscope may possess an angle shaft tip (e.g., a 30° shaft tip or 45° shaft tip). The components of the view optimizing assembly 10 may be made from plastic materials

(extruded and/or molded), but other suitable materials, such as metal or a composite material, or combinations thereof could be used.

[0100] As will be described in greater detail, the view optimizing assembly 10 facilitates intra-operative defogging, surgical debris deflection, and cleaning of a laparoscope lens during minimally invasive surgery, while also maintaining visualization of the surgical site. The view optimizing assembly 10 is intended to be a single-use, disposable laparoscopic accessory. The view optimizing assembly 10 is desirably a sterile accessory for immediate set up and use on a sterile operating field. [0101] The view optimizing assembly 10 comprises a multi-lumen sheath assembly 14, which mounts over the shaft of the laparoscope 12. In one illustrated embodiment, there are five lumens in the sheath 14. The end of the sheath 14 is sized and configured to match the size and configuration of the corresponding laparoscope 12, having a blunt tip or an angled tip.

[0102] The assembly 10 includes a tubing set 16 to connect the sheath 14 to an existing carbon dioxide (C0₂) insufflation circuit and to a source of a flushing liquid 72. Tubing may also be used to connect to an exhaust gas control system as described herein. A manifold 18 on the proximal end of the sheath 14 includes a quick exchange coupling 20 that mates with a quick exchange coupler 22 on the tubing set 16, to quickly couple the tubing set 16 in fluid communication with the interior lumens of the sheath 14.

[0103] In use, the view optimizing assembly 10 makes possible the practice of a surgical method for maintaining clear visualization of the surgical site without removing the laparoscope 12 from the abdominal cavity for the purpose of cleaning or de-fogging its lens. Furthermore, the view optimizing assembly 10 also makes possible a surgical method for maintaining clear visualization that includes the ability to make a quick exchange of laparoscopes having different operating characteristics (e.g., laparoscopes with different tip angles, lengths, or diameters) entirely on the sterile operating field and without interference with the preexisting surgical set-up on the sterile operating field. The view optimizing assembly 10 integrates with the existing suite of minimally invasive instrumentation. It does not interfere with the surgical set-up, and it requires minimal change in the process or practice of a surgical operating room (OR) team.

[0104] The view optimization assembly 10 desirably comes packaged for use in sterile peel away pouches. The pouches contain the components of the view optimization assembly 10 as shown in FIGS. 8 and 9, including the sheath 14, the manifold 18 that is assembled to the sheath 14 and that includes a quick exchange coupling 20; the tubing set 16 which includes a quick exchange coupler 22 that mates with the quick exchange coupling 20 on the manifold 18; and (optionally) a vent device 24. The vent device 24 comprises a tube with an inline membrane 62 that restricts air flow through the tube. A proximal end of the tube is sized and configured to couple to a stopcock valve of a conventional trocar. In use, the vent device 24 provides a controlled leak of CO2 from the operating cavity. Additionally, the kits include an exhaust line and filter (FIGS. 14-17).

[0105] The sheath 14 is sized and configured to receive a laparoscope 12 having a prescribed tip angle, length, and diameter. The distal end of the sheath 14 includes a stop 26. The stop 26 prevents advancement of the laparoscope 12 beyond the distal end of the sheath 14. The stop 26 assures that the lens at the distal end of the laparoscope 12 rests in a desired, generally coterminous alignment with the distal end of the sheath 14. [0106] In use, it is expected that the laparoscope 12 will be inserted into the sheath 14 by a scrub nurse during set-up for the operation. The assembled laparoscopic and sheath 14 will then be handed as a unit to personnel at the operating room (OR) table at the desired time. The laparoscope 12 is then connected in a conventional way by personnel at the OR table in conventional fashion to a light cable (which directs light to illuminate the operative field) and the camera cable (which takes the image from the scope and displays it on monitors in the OR). The sheath 14 is sized and configured not to interfere with this normal set-up of the laparoscope 12.

The gas provided to operate the vision system is provided by a system as described herein.

[0107] In use, the assembled laparoscopic and sheath 14 are placed as a unit through a trocar into the body cavity (e.g., the abdominal cavity), for viewing the surgical procedure as it is performed.

[0108] An insufflation gas outlet is connected to the first trocar for use in conjunction with a laparoscope as well as additional connections to supply gas to a surgical vision clearing system used in conjunction with the laparoscope with additional flow clearance aids such as an injectable surfactant and an air burst bulb. This view also shows a modified trocar for providing exhaust flow readings or data to the insufflator with continuous exhaust flow pressure sensing. Additional details are provided in U.S. Patent Application No. 13/198,406, filed August 4, 201 1 , now U.S. Patent No. 9,21 1,059, incorporated herein by reference. The connections to aid use of a FloShield system are modified as described herein.

[0109] In still another alternative embodiment, the functionality provided by the systems of FIGs. 4 and 5 may be separated in a number of different ways, providing separate components or allowing use of the inventive exhaust pressure monitoring control in different configurations but in concert with conventional insufflation systems. By way of example, a conventional insufflation system may be used to supply a continuous flow of insufflation gas. In conjunction with the operation of this insufflation supply system is a system configured to supply insufflation gas to the FloShield system and also obtain the exhaust line pressure reading and provide feedback control of the overall system. In other words, the functions provided by the configurations that employ both the FloShield and insufflation supply may be divided into separate components that operate in a coordinated fashion.

[0110] FIG. 1 OA is a front view of a smoke evacuation system. This system receives an input from a line connected to a trocar in communication with the insufflated space. The line may be provided with a particle, odor, and moisture filter as described herein. The gas is provided into the system where a valve under control of the computer controller can close, isolating the exhaust line to the trocar to obtain a pressure reading. The pressure reading is representative of the pressure in the insufflated surgical space. Additionally, the computer controller has instructions for comparing the pressure reading to that of a threshold value to maintain pressure in the insufflated cavity. In this way the smoke evacuation system of FIG. 10A includes selected capabilities and features of FIG. 1, 2, 3, 4 and 18-22 in various alternative embodiments.

[0111] FIG. 10B is a front view of a FloShield vision protection system for computer- controlled operations to supply pressurized gas to a FloShield device and evacuate gas from an insufflated surgical cavity via the illustrated gas line connections. In one aspect, the vision protection and smoke evacuation system is adapted and configured to supply a steady gas supply and pressure to a vision protection system and also withdraw gas from the insufflated cavity using a gas line that doubles as a pressure monitoring line as described herein. In this way, a standard insufflation system is used to provide insufflation gas to a surgical site and to maintain insufflation pressure according to a desired set point. At the same time, a system configured as in FIG. 10B provides supply gas to operate a vision protection system and to exhaust gas from the insufflated space so as to balance the gas supplied to operate the vision protection device. The vision protection system and exhaust pressure monitoring system operate harmoniously within the pressure regime maintained by the standard insufflator.

[0112] In one embodiment, the system of FIG. 10B provides a steady 5 liters per minute gas flow through FloShield with a pressure of 2-5 psi in that line. As illustrated in FIG. 4, a smoke evacuation line is connected to a 2nd trocar. The smoke and evacuation line will remove gases from the insufflated cavity at a rate that exceeds the supply gas to the FloShield vision protection device. In one aspect, the smoke and evacuation line will dynamically adjust to provide gas removal from the insufflated space at a rate from about 1 L per minute to about 6 L per minute more than the rate of gas supplied to the FloShield vision protection system.

[0113] In one alternative configuration, the gas flow in the FloShield protection device delivery line will be reduced by an orifice that is part of a valve, such as a trumpet pressure relief valve. The valve may be positioned closer to the FloShield vision protection device and the supply system.

[0114] Operation of the pressure relief valve may be provided by a suitably configured button to act as a gas burst deployment button. Whereby, on activation of the gas burst deployment button, the built up of pressure in the length of the delivery tubing will "dump" into the FloShield vision protection sheath. A burst of gas from the FloShield vision protection sheath may be used advantageously in a number of ways. For example, the burst of gas from the FloShield device may be used to blow smoke away from the surgical site. In yet another example, the burst of gas from the FloShield device may be used to in conjunction with a FloShield FloX configured device (see FIGs. 8 and 9) for blowing Flo-X off the surgical device lens. In still other aspects, the manual burst bulbs shown in FIGs. 8 and 9 are omitted and the tubing lines reconfigured such that the burst button functionality described above is used for FloX clearance functionality. In one exemplary embodiment, a burst deployment button may be integrated into a FloShield vision protection device as illustrated and described in commonly assigned U.S. Patent Application Publication US 2008/0319266 entitled "Device for Maintaining Visualization With Surgical Scopes" which is incorporated herein by reference in its entirety. In particular, exemplary valve and button configurations into a control handle are shown, for example, in FIGs. 1 1 , 12 and 13. In some embodiments, the manual valves or bulbs illustrated are omitted and all additional gas burst is provided by operation of the gas burst button.

[0115] In still another aspect, the intergrated exhaust gas and vision protection gas control system of FIG. 10B is configured with a computer controller having computer readable instructions as described above as well as instructions for controlling the flow rate in the vision protection system delivery line so that if the gas burst deployment button stays depressed, gas flow provided to the FloShield vision protection device is only 5 L/min.

[0116] In still another aspect, the system of FIG. 10B is configured to operate without pressure monitoring and control using the pressure of the insufflated space. By way of example, the system of FIG. 10B operates alongside a separate standalone insufflator that is maintaining the pressure within the insufflated cavity. An embodiment of the system of FIG. 10B operates to provide gas to the FloShield device and to always evacuate gas from the insufflated surgical space at a rate higher than the gas supplied to the FloShield device. In this way, since more gases are removed by the system of FIG. 10B than are introduced into the FloShield device, the system of FIG. 10B may operate in a supply and removal control loop system without pressure monitoring. In other aspects, as described above, system of FIG. 10B may also be configured to use pressure monitoring of the insufflated surgical space by intermittent occlusion of the smoke and evacuation line to allow for static pressure measurement as part of the control system.

[0117] In one aspect, the bulb 180/74 respectively, shown in FIGS. 8 and 9 may be removed and the vision system operated in burst mode as described herein. FIG. 1 1 shows the lens guard 210 and the flow controller 220 of the view optimizer 200 joined together as a unitary construction. It should be understood that the lens guard 210 and the flow controller 220 could be provided as two or more separate pieces that are used remotely from one another and not joined together as a unitary construction. FIG. 12 shows a side view of another exemplary embodiment of the view optimizer 200 of the present application. In this embodiment, the view optimizer 200 is in two separate pieces (the prime designation, e.g. 210', is used to reference features that are common between the embodiments depicted in FIG. 1 1 and FIG. 12). The lens guard 210' is attached at its proximal end 214 to the laparoscope 100, and comprises a vent actuator 280, and a fluid conduit 270 that is in communication with the flow controller 220' (connection not shown). The flow controller 220' is depicted as an ergonomic device to be grasped in an operator's hand, with a flow actuator/regulator 250' adapted to be depressed by the operator's thumb, and a burst flow actuator/regulator 260' adapted to be depressed by the flexion of the operator's fingers, to deliver the flow of gas or liquid from one or more inlet sources (not shown) through the fluid conduit 270, for delivery to the objective lens of the scope through distal end 212 of the lens guard 210. In the depicted embodiment, the vent actuator 280 is under the control of the scope operator, and may be adjusted as needed to assist in maintaining visualization. Of course it will be understood that in alternate embodiments, one or more of the actuators may be eliminated, and their locations may be switched, or all actuators may be located on the flow controller 220' or may be located at yet another controller, such as a separate foot activated controller (not shown). In yet other embodiments, the lens guard 210 and the flow controller 220 could be provided as two or more separate pieces that are assembled for use. While the lens guard 210 and the flow controller 220 of the illustrated embodiment are formed from plastic, other suitable materials, such as metal or a composite material, or combinations of these could also be used.

[0118] Referring to FIG. 13, the view optimizer 200 will now be described with more particularity. As mentioned earlier, the lens guard 210 is an elongated, cylindrical tube.

However, it should be understood that that the lens guard 210 is not limited to this shape and configuration and other suitable shapes and configurations could also be used in additional embodiments. Examples of additional constructions have been previously described. Examples of additional cross-sectional shapes that could be used for the lens guard 210 include, but are not limited to, rectangular, triangular, oval, etc. The lens guard 210 can have any shape or configuration which allows it to surround the distal tip 120 of the laparoscope 100. Additional embodiments of the view optimizer 200 may include a lens guard which has an angled portion to correspond with scopes with angled portions, such as 450 or 300 angled scopes. The lens guard 210 of the illustrated embodiment is substantially rigid. However, it should be understood that additional embodiments of the view optimizer may include a flexible lens guard, which is adapted for use with a flexible scope. The lens guard 210 of the embodiment illustrated in FIG. 1 1 is fashioned from plastic, but other suitable materials such as metal or a composite material or combinations of these could also be used.

[0119] As shown in FIG. 13, the lens guard 210 of the illustrated embodiment includes an adapter ring 302, a guard tube 304, an exhaust ring 306, and an end ring 308. However, it should be understood that additional embodiments of the view optimizer may include any number of channels defined within the guard tube, such as, for example, a single channel for multiple functions, or two or more channels each having distinct functions. The channels may have a variety of sizes, shapes and configurations that allow for the passage of gas and/or liquid. Some embodiments include two channels dedicated to delivery of gas from to the objective lens of the laparoscope, and one channel for the passage of the liquid to the objective lens of the laparoscope. Additional embodiments of the view optimizer may include guard tubes that have any number of channels dedicated to any combination of gas for delivery to the objective lens of the laparoscope, liquid for delivery to the objective lens of the laparoscope, and/or exhaust gas. As mentioned previously, various additional embodiments of the view optimizer may utilize both gas and liquid or only one of gas or liquid for delivery to the objective lens of the laparoscope. In some embodiments, the view optimizer may lack exhaust channels. Generally, depending on the intended functionality of the lens guard, the one or multiple channels of the guard tube will be suitably adapted.

[0120] FIG. 14 shows a disposable filter system 1420 for use in the removal of unwanted gases and odors. Filter 1421 comprises a housing having a fluid inlet 1422 and a fluid outlet 1423. A first gas permeable screen 1424 that allows gas to flow threrethrough is located on one side of a filter media 1426 and a second gas permeable screen 1425 is located on the opposite side of filter media 1426 for the purposes of maintaining the filter media 1426 in position for surgical waste gas to flow threrethrough.

[0121] Located downstream of filter media 1426 is a water removable material or moisture absorbent filter media 1427. An example of a commercially available desiccant for removal of water is silica gel. Moisture absorbent material 1427 is retained on one side by gas permeable screen 1425 and on the opposite side by gas permeable screen 1428 to thereby hold the filter media 1427 in position as the surgical waste gas flows threrethrough.

[0122] Located downstream of moisture absorbent filter media 1427 is a carbon monoxide filter media 1429 which is bounded on one side by gas permeable screen 1428 and on the other side by gas permeable screen 1430. Thus, in the filter system 1420 the surgical waste gas flows through filter media 1426, moisture absorbent filter media 1427 and carbon monoxide filter media 1429, which removes the carbon monoxide, before the surgical waste gas is discharged into the operating room.

[0123] While filter 1421 with a carbon monoxide filter media could be coupled directly to the trocar 1418 it is preferred to position the carbon monoxide filter media 1429 downstream of a moisture absorbent filter media 1427 in order to extend the life of the carbon monoxide filter media 1429 by preventing saturation of the carbon monoxide filter media. In addition, by incorporating a filter media to remove formaldehyde, such as activated charcoal, one can remove formaldehyde upstream of the carbon monoxide filter media 1429, to further extend the life of the carbon monoxide filter media 1429.

[0124] In the filtration system 1420, an odor-removing filter media such as an activated carbon filter media 1426 upstream of the carbon monoxide filter media 1429 to remove formaldehyde and other gases that can consume the carbon monoxide filter media are located as part of a single filter 1421.

[0125] A benefit of locating the carbon monoxide filter media 1429 downstream of the moisture adsorbent filter media 1427 is that one is able to extend the life the carbon monoxide filter media 1429 by reducing the dew point and moisture vapor content of the surgical waste gas flowing through the carbon monoxide filter media.

[0126] Filter media to reduce the dew point of the gas prior to contact with the carbon monoxide filter media typically include water vapor removers such as molecular sieves, silica gel or activated alumina. Other types of devices to reduce the dew point of the surgical waste gas can also be utilized. For example, devices such as refrigerated air dryers, condensers, heat exchangers, membrane air dryers and other types of compressed air dryers.

[0127] Formic acid may also be present in the surgical waste gas. Vapor adsorbents such as activated carbon can also absorb some of formic acid, but it may be beneficial to incorporate an acid-scrubbing desiccant such as a mixture of sodium and calcium hydroxide. Should an acid- scrubbing filter media be included as part of filter 1421 , it is beneficial to configure the acid- scrubbing filter media upstream or prior to the moisture-removing filter media to avoid premature saturation of the moisture removing filter media.

[0128] A feature of the filtration system 1420 is that it allows one to quickly connect to existing portable smoke evacuators that vent gasses to an operating room atmosphere through the use of standard tubing.

[0129] In the embodiment shown in FIG. 14 the incoming surgical waste gas enter inlet 1422, flows through screen 1424 and into the carbon filter media 1426. After removal of odors and other materials the surgical waste gas flows through the activated charcoal or carbon filter media 1426. The surgical waste gas, which contains carbon monoxide, flows though the moisture reducing filter media 1427, which reduces the moisture content of the surgical waste gas. Once the surgical waste gas containing the carbon monoxide enters the carbon monoxide filter media 1429 the carbon monoxide is removed by the filter media 1429 and the remaining surgical waste gas is either directed to a further filter or is vented to the operating room. A feature of the filtrations system 1420 of FIG. 14 is that it can be quickly and easily connected to other systems through the use of flexible tubing couplings 1422 and 1423. [0130] FIG. 15 shows an alternate embodiment of a filtration system 1460 comprising a set of three gangable filters, a first filter 1440, a second filter 1441 and a third filter 1442. Each of filters 1440, 1441, and 1442 has a fluid inlet on one side and a fluid outlet on the opposite side.

[0131] Filter 1440 includes an inlet 1440a and an outlet 1440b, which is shown coupled to inlet 1441a through a flexible tubing coupling. Filter 1440 contains a single filter media such as carbon or activated charcoal. The filter 1441 contains a single filter media such as a moisture removal filter media and filter 1442 contains a single filter media such as a carbon monoxide filter media that removes carbon monoxide from the surgical waste gas.

[0132] In operation the fluid outlet 1440b of filter 1440 connects to filter inlet 1441 a of filter 1441 and the filter outlet 1441 b connects to the fluid inlet 1442a of filter 1442 through a coupling (not shown) to provide a ganged arrangement of filters that are individually changeable. For example filter 1440 can contain a filter media such as activated charcoal, filter 1441 can contain a water vapor remover such as a descant or the like and filter 1442 can contain a carbon monoxide filter media such as sodium hydroxide and calcium hydroxide. During the filtration of the surgical waste gas if one or more of the filters is spent the filter can be replaced with a fresh filter.

[0133] Thus, there is a method of filtering surgical space exhaust comprising the steps of: directing the surgical waste gas through a carbon monoxide filter media before discharging the surgical waste gas into the operating room atmosphere or into a gas flow control system described herein. To enhance the life of the carbon monoxide filter media one can include the step of directing the surgical waste gas through a vapor removal filter media before directing the surgical waste gas through the carbon monoxide filter media. To remove particles in the surgical waste gas one can direct the surgical waste gas through a particle filter before directing the surgical waste gas through the carbon monoxide filter media. To remove formaldehyde from the surgical waste gas one can direct the surgical waste gas through a formaldehyde filter media before directing the surgical gas into the carbon monoxide filter media.

[0134] FIG. 16 shows apparatus for removing carbon monoxide gas from a surgical waste gas generated during a medical procedure. The system includes a body evacuation device, such as a trocar 1418, connected to a filter system 1420. A line connected to the trocar 1418 allows one to vent the surgical waste gas from a body cavity through a device such as trocar 18 and into a filter system 1420 prior to entering an exhaust systems or insufflator as described herein. That is, the surgical waste gas flows through trocar 1418, conduit 1422 through filter 1421 and then vents to the operating room atmosphere through outlet 1423 or is connected to an exhaust gas inlet described herein. During the passage of the exhaust gas or the surgical waste gas through the filter 1421 a filter media therein removes the carbon monoxide from the surgical waste gas. [0135] FIG. 17 shows a filter system 1420 for removing carbon monoxide gas from a surgical waste gas generated during a medical procedure including a particle filter 1450 located upstream of the filter 1421. In this embodiment the surgical waste gas flows from the trocar 1418, through tubing 1451 and then into the particle filter 1450 to remove unwanted

contaminates from the surgical waste gas before the surgical waste gas enters the filter 1421. An outlet 1452 connects to inlet 1422 of filter 1421 through a flexible coupling to permit flow from filter 1450 to filter 1421. The surgical waste gas with particle contaminates removed therefrom by filter 1450 then flows through conduit 1452 into the filter system 1420 that includes a filter 1421 that contains a filter media 1429 for removing unwanted carbon monoxide gas from the surgical waste gas. Optionally, filters 1420 may include moisture traps.

[0136] FIG. 18 is a flow chart 1800 of exemplary steps for independent operation of a smoke evacuation system during operation of an insufflator to maintain an insufflated cavity. First, at step 1805, deliver gas at a first flow rate under control of a smoke evacuation system to an insufflated cavity using a first line connected to a medical instrument vision clearing system within the insufflated cavity. Next, at step 1810, remove gas from the insufflated cavity under control of the smoke evacuation system using a second line connected to a trocar in

communication with the insufflated cavity. Then, at step 1815, stop the removing gas from the insufflated cavity step using a valve under control of the smoke evacuation system controller. After, at step 1820, measure a pressure in the insufflated cavity using the second line during the stopping the removing gas step. Next, at step 1825, compare the result of the measure the pressure in the insufflated cavity step to a smoke evacuation set point using the smoke evacuation system controller to determine if the pressure in the insufflated cavity is above or below the smoke evacuation set point. Lastly, at step 1830, continue the stopping the removing gas step if the pressure in the insufflated cavity is below the smoke evacuation set point and resume the removing gas from the insufflated cavity step if the pressure in the insufflated cavity is above the smoke evacuation set point.

[0137] FIG. 19 is a flow chart 1900 of exemplary steps for operation of an insufflator having smoke evacuation capabilities. First, at step 1905, deliver a gas under control of an insufflator using a first line in communication with a first trocar in communication with a body cavity to provide an insufflated body cavity at an insufflation pressure. Then, at step 1910, remove gas under control of an insufflator from an insufflated cavity using a second line in a second trocar in communication with the insufflated cavity. After, at step 1915, stop the removing gas from the insufflated cavity step using a valve under control of the insufflator controller. Next, at step 1920, measure a pressure in the insufflated cavity using the second line during the stopping the removing gas step. Then, at step 1925, compare the result of the measuring the pressure in the insufflated cavity step to a smoke evacuation set point using the insufflator controller to determine if the pressure in the insufflated cavity is above or below a smoke evacuation set point. After, at step 1930, continue the stopping the removing gas step if the pressure in the insufflated cavity is below the smoke evacuation setpoint and resume the removing gas from the insufflated cavity step if the pressure in the insufflated cavity is above the smoke evacuation set point. Finally, at step 1935, perform the delivering a gas under control of the insufflator step during the removing, stopping, measuring, comparing and continuing steps.

[0138] FIG. 20 is a flow chart 2000 of exemplary steps for operation of an insufflator having smoke evacuation and vision cleaning system capabilities. First, at step 2005, deliver a gas under control of an insufflator using a first line in a first trocar in communication with a body cavity to provide an insufflated body cavity at an insufflation pressure. Then, at step 2010, deliver a gas under control of the insufflator at a first flow rate to the insufflated cavity using a second line connected to a medical instrument vision clearing system in use within the insufflated body cavity. Next, at step 201 5, remove gas under control of the insufflator from the insufflated cavity using a third line in a second trocar in communication with the insufflated cavity. After, at step 2020, stop the removing gas from the insufflated cavity step using a valve under control of the insufflator controller. Then, at step 2025, measure a pressure in the insufflated cavity using the third line during the stopping the removing gas step. Then, at step 2030, compare the result of the measuring the pressure in the insufflated cavity step to a smoke evacuation set point using the insufflator controller to determine if the pressure in the insufflated cavity is above or below a smoke evacuation set point. Next, at step 2035, continue the stopping the removing gas step if the pressure in the insufflated cavity is below the smoke evacuation setpoint and resuming the removing gas from the insufflated cavity step if the pressure in the insufflated cavity is above the smoke evacuation set point. Finally, at step 2040, perform the step of delivering a gas under control of the insufflator using a first line during the removing, stopping, measuring, comparing and continuing steps.

[0139] FIG. 21 is a flow chart 2100 of exemplary steps for integrated operation of a smoke vision clearing and smoke evacuation system during separate operations of an insufflator. First, at step 2105, deliver gas at a first flow rate under control of a smoke evacuation system to an insufflated cavity using a first line connected to a medical instrument vision clearing system within the insufflated cavity. Then, at step 21 10, remove gas from the insufflated cavity under control of the smoke evacuation system using a second line connected to a trocar in

communication with the insufflated cavity. Next, at step 21 15, stop the removing gas from the insufflated cavity step using a valve under control of the smoke evacuation system controller. After, at step 2120, measuring a pressure in the insufflated cavity using the second line during the stopping the removing gas step. Then, at step 2125, compare the result of the measuring the pressure in the insufflated cavity step to a smoke evacuation set point using the smoke evacuation system controller to determine if the pressure in the insufflated cavity is above or below the smoke evacuation set point. Lastly, at step 2130, continue the stopping the removing gas step if the pressure in the insufflated cavity is below the smoke evacuation set point and resume the removing gas from the insufflated cavity step if the pressure in the insufflated cavity is above the smoke evacuation set point.

[0140] FIG. 22 is a flow chart 2200 of an exemplary smoke evacuation and vision clearing system as in FIG. 21 including an additional step of a burst mode operation. First, in step 2205, deliver gas at a base flow rate under control of a smoke evacuation system to an insufflated cavity using a first line connected to a medical instrument vision clearing system within the insufflated cavity. Then, at step 2210, remove gas under control of the smoke evacuation system from the insufflated cavity using a second line connected to a trocar in communication with the insufflated cavity. Next, at step 2215, stop the removing gas from the insufflated cavity step using a valve under control of the smoke evacuation system controller. After, at step 2220, measure a pressure in the insufflated cavity using the second line during the stopping the removing gas step. Then, at step 2225, compare the result of the measuring the pressure in the insufflated cavity step to a smoke evacuation set point using the smoke evacuation system controller to determine if the pressure in the insufflated cavity is above or below the smoke evacuation set point. Next, at step 2230, continue the stopping the removing gas step if the pressure in the insufflated cavity is below the smoke evacuation setpoint and resume the removing gas from the insufflated cavity step if the pressure in the insufflated cavity is above the smoke evacuation set point. Then, at step 2235, dispense a lens clearing solution to the medical instrument vision clearing system while in use within the insufflated cavity. Finally, at step 2240, deliver gas under control of the smoke evacuation system at a burst flow rate to the first line connected to the medical instrument vision clearing system to assist in removal of the lens clearing solution and thereafter resume the step of delivering gas at the base flow rate.

[0141] Additional details for insufflator operations, computer control and monitoring, along with various sensors or other components may be appreciated with reference to the following U.S. Patent 5,423,741 entitled "APPARATUS AND METHOD FOR THE INSUFFLATION OF GAS INTO A BODY CAVITY;" U.S. Patent 5, 246, 419 entitled "INTRA-ABDOMINAL INSUFFLATION APPARATUS;" U.S. Patent 5, 152, 745 entitled "INSUFFLATOR;" U.S. Patent 5,013, 294 entitled "INSUFFLATION DEVICE FOR ENDOSCOPIC

INTERVENTION;" U.S. Patent Application Publication US 2005/0015043 entitled "GAS FLOW TROCAR ARRANGEMENT;" U.S. Patent Application Publication US 2007/0088275 entitled "TROCAR ASSEMBLY WITH PNEUMATIC SEALING;" and still further, additional details of the a variety of disposable pressure sensors may be appreciated in the materials provided in "APPLICATION OF DISPOSABLE PRESSURE SENSORS TO

POSTCENTRIFUGATION FILTRATION PROCESS" and General Electric Measurement & Control MEMS Pressure Sensor Solutions brochure, each of which is hereby incorporated by reference in its entirety for all purposes.

[0142] When a feature or element is herein referred to as being "on" another feature or element, it can be directly on the other feature or element or intervening features and/or elements may also be present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being "connected", "attached" or "coupled" to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being "directly connected", "directly attached" or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.

[0143] Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as "/".

[0144] Spatially relative terms, such as "under", "below", "lower", "over", "upper" and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as "under" or "beneath" other elements or features would then be oriented "over" the other elements or features. Thus, the exemplary term "under" can encompass both an orientation of over and under. The device may be otherwise oriented (rotated

90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms "upwardly", "downwardly", "vertical", "horizontal" and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.

[0145] Although the terms "first" and "second" may be used herein to describe various features/elements (including steps), these features/elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one

feature/element from another feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention.

[0146] Throughout this specification and the claims which follow, unless the context requires otherwise, the word "comprise", and variations such as "comprises" and "comprising" means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term

"comprising" will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0147] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word "about" or "approximately," even if the term does not expressly appear. The phrase "about" or

"approximately" may be used when describing magnitude and/or position to indicate that the value and/or position described is within a reasonable expected range of values and/or positions. For example, a numeric value may have a value that is +/- 0.1% of the stated value (or range of values), +/- 1 % of the stated value (or range of values), +/- 2% of the stated value (or range of values), +/- 5% of the stated value (or range of values), +/- 10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value " 10" is disclosed, then "about 10" is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that "less than or equal to" the value, "greater than or equal to the value" and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value "X" is disclosed the "less than or equal to X" as well as "greater than or equal to X" (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point "10" and a particular data point "15" are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 1 1 , 12, 13, and 14 are also disclosed.

[0148] Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others.

Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.

The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term "invention" merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.

Claims

What is claimed is:

An exhaust treatment system for use with an insufflated surgical space, comprising: an exhaust treatment system having an exhaust flow inlet port; an exhaust port; a valve that when closed isolates the exhaust flow inlet port from the exhaust port; a pressure sensor between the valve and the exhaust inlet port;

an exhaust treatment system controller having computer readable instructions for

operating the valve; obtaining a pressure reading from the pressure sensor and comparing the pressure reading to an insufflated surgical space pressure set point; and operating the valve to remain closed while obtaining a pressure reading and while the pressure reading is below the insufflated surgical space pressure set point.

2. The exhaust treatment system of claim 1 further comprising: an exhaust line connected to a second trocar and to the exhaust flow inlet port; and

a filter in communication with the exhaust line to filter the exhaust gas flow prior to entry into the exhaust flow inlet port.

3. The exhaust treatment system of claim 2 wherein the filter is configured to one or more of particles, odors and moisture from the gas flow in the exhaust line.

4. The exhaust treatment system of claim 1 further comprising: a surgical field vision clearing system outlet port; a surgical field vision clearing system gas flow control valve and a gas supply line connected to the surgical field vision clearing system outlet port and to a surgical field vision clearing system.

5. The exhaust treatment system of claim 4 the exhaust treatment system controller further comprising computer readable instructions for operating the surgical field vision clearing system gas flow control valve to provide a base flow rate to the surgical field vision clearing system and a burst flow rate to the surgical field vision clearing system.

6. The exhaust treatment system of claim 5 further comprising a trigger in communication with the exhaust treatment system controller and computer readable instructions to provide the burst flow rate to the surgical field vision clearing system when the trigger is operated.

7. The exhaust treatment system of claim 6 wherein the trigger is a foot pedal, a push button, a lever or a switch.

8. An insufflator having exhaust pressure sensing feedback, comprising:

an insufflation gas inlet port and an insufflation gas outlet port, a surgical field vision clearing system outlet port, an insufflation gas control valve, a surgical field vision clearing system gas flow control valve, an insufflation gas pressure regulator in communication with the insufflation gas inlet and the insufflation gas and surgical field vision clearing system control valves;

an exhaust flow inlet port;

an exhaust port;

an insufflation pressure controller having computer readable instructions for measuring and exhaust flow pressure from the exhaust flow inlet port; comparing the exhaust flow pressure to an insufflation pressure set point; and adjusting the insufflation gas control valve and the surgical field vision clearing system gas flow control valve in response to the result of the comparing step to control the insufflation pressure in an insufflated surgical space in communication with the insufflator.

9. The insufflator of claim 8 further comprising: a first gas supply line connected to a first trocar and to the insufflation gas outlet port, a second gas supply line connected to the surgical field vision clearing system and to the surgical field clearing system outlet port, and an exhaust line connected to a second trocar and to the exhaust flow inlet port; and

10. The insufflator of claim 9 wherein the filter is configured to one or more of particles, odors and moisture from the gas flow in the exhaust line.

1 1 . The insufflator of claim 8 further comprising a valve under control of the insufflation pressure controller that when closed stops the flow of gas in the in the exhaust line and a pressure sensor in communication with the insufflation pressure controller, the pressure sensor positioned and configured to provide a pressure reading from the exhaust line between the valve and the second trocar.

12. The insufflator of claim 1 1 further comprising computer readable instructions in the insufflation controller to operate the valve to remain closed while the pressure reading in the exhaust line is below an exhaust line set point and to open the valve while the pressure reading in the exhaust line is above an exhaust line set point.

13. The insufflator of claim 12 wherein the exhaust line set point corresponds to a minimum pressure setting for an insufflated cavity in communication with the second trocar.

14. An insufflator having exhaust pressure sensing feedback, comprising:

an insufflation gas inlet port and an insufflation gas outlet port, an insufflation gas

pressure regulator and an insufflation gas control valve in communication with the insufflation gas inlet and outlet ports;

an exhaust flow inlet port;

an exhaust port;

an insufflation pressure controller having computer readable instructions for measuring and exhaust flow pressure from the exhaust flow inlet port; comparing the exhaust flow pressure to an insufflation pressure set point; and adjusting the insufflation gas control valve in response to the result of the comparing step to control the insufflation pressure in an insufflated surgical space in communication with the insufflator.

15. The insufflator of claim 14 further comprising: a gas supply line connected to a first trocar and to the insufflation gas outlet port and an exhaust line connected to a second trocar and to the exhaust flow inlet port; and

16. The insufflator of claim 15 wherein the filter is configured to one or more of particles, odors and moisture from the gas flow in the exhaust line.

17. The insufflator of claim 14 further comprising a valve under control of the insufflation pressure controller that when closed stops the flow of gas in the in the exhaust line and a pressure sensor in communication with the insufflation pressure controller, the pressure sensor positioned and configured to provide a pressure reading from the exhaust line between the valve and the second trocar.

18. A method for maintaining an insufflation gas within an insufflated surgical space, comprising:

providing an insufflation gas to a continuous insufflation gas control system;

metering the flow of the insufflation gas delivered through a first trocar into the

insufflated surgical space;

exhausting a gas from the insufflated surgical space via a second trocar;

providing the gas from the exhausting step into the continuous insufflation gas control system;

obtaining a pressure measurement of the insufflated surgical space using the gas from the insufflated surgical space; and

regulating the flow of the insufflation gas in the providing an insufflation gas step in response to the obtaining a pressure measurement of the insufflated surgical space steps.

19. The method for maintaining an insufflation gas according to claim 18 further comprising: filtering the gas in the exhausting a gas step to remove at least one of a particle, an odor or a moisture content prior to performing the providing the gas step.

20. The method for maintaining an insufflation gas according to claim 18 the obtaining a pressure measurement step further comprising: closing a valve to stop the exhausting a gas step and measuring a pressure in a line in communication with the second trocar.

21 . The method for maintaining an insufflation gas according to claim 20 further comprising continuing the closing a valve step so long as the pressure measurement is below a threshold pressure used to maintain a minimum insufflation pressure in the insufflated surgical space.

22. A method for maintaining an insufflation gas within an insufflated surgical space and operating a surgical field vision clearing system, comprising:

providing an insufflation gas to a continuous insufflation gas control system;

insufflated surgical space;

metering the flow of the insufflation gas delivered into the insufflated surgical space by operation of the surgical field vision clearing system;

exhausting a gas from the insufflated surgical space via a second trocar; providing the gas from the exhausting step into the continuous insufflation gas control system;

regulating the flow of the insufflation gas in the metering steps in response to the

pressure measurement from the obtaining a pressure measurement step.

23. The method for maintaining an insufflation gas according to claim 22 further comprising: filtering the gas in the exhausting a gas step to remove at least one of a particle, an odor or a moisture content prior to performing the providing the gas step.

24. The method for maintaining an insufflation gas according to claim 22 the obtaining a pressure measurement step further comprising: closing a valve to stop the exhausting a gas step and measuring a pressure in a line in communication with the second trocar.

25. The method for maintaining an insufflation gas according to claim 24 further comprising continuing the closing a valve step so long as the pressure measurement is below a threshold pressure used to maintain a minimum insufflation pressure in the insufflated surgical space.

26. A method of providing smoke evacuation to an insufflated surgical space, comprising: operating an insufflator to provide an insufflated cavity;

delivering a gas at a first flow rate under control of a smoke evacuation system to the insufflated cavity using a first line connected to a medical instrument vision clearing system within the insufflated cavity;

removing gas from the insufflated cavity under control of the smoke evacuation system using a second line connected to a trocar in communication with the insufflated cavity;

stopping the removing gas from the insufflated cavity step using a valve under control of the smoke evacuation system controller;

measuring a pressure in the insufflated cavity using the second line during the stopping the removing gas step;

comparing the result of the measure the pressure in the insufflated cavity step to a smoke evacuation set point using the smoke evacuation system controller to determine if the pressure in the insufflated cavity is above or below the smoke evacuation set point; and continuing the stopping the removing gas step if the pressure in the insufflated cavity is below the smoke evacuation setpoint and resuming the removing gas from the insufflated cavity step if the pressure in the insufflated cavity is above the smoke evacuation set point.

27. A method of operating an insufflator having smoke evacuation capabilities, comprising: delivering a gas under control of an insufflator using a first line in communication with a first trocar in communication with a body cavity to provide an insufflated body cavity at an insufflation pressure;

removing gas under control of an insufflator from an insufflated cavity using a second line in a second trocar in communication with the insufflated cavity;

stopping the removing gas from the insufflated cavity step using a valve under control of the insufflator controller;

comparing the result of the measuring the pressure in the insufflated cavity step to a smoke evacuation set point using the insufflator controller to determine if the pressure in the insufflated cavity is above or below a smoke evacuation set point; continuing the stopping the removing gas step if the pressure in the insufflated cavity is below the smoke evacuation setpoint and resuming the removing gas from the insufflated cavity step if the pressure in the insufflated cavity is above the smoke evacuation set point; and

performing the delivering a gas under control of the insufflator step during the removing, stopping, measuring, comparing and continuing steps.

28. A method for operating an insufflator having smoke evacuation and vision cleaning system capabilities, comprising:

delivering a gas under control of an insufflator using a first line in a first trocar in

communication with a body cavity to provide an insufflated body cavity at an insufflation pressure;

delivering a gas under control of the insufflator at a first flow rate to the insufflated

cavity using a second line connected to a medical instrument vision clearing system in use within the insufflated body cavity;

removing gas under control of the insufflator from the insufflated cavity using a third line in a second trocar in communication with the insufflated cavity; stopping the removing gas from the insufflated cavity step using a valve under control of the insufflator controller;

measuring a pressure in the insufflated cavity using the third line during the stopping the removing gas step;

performing the step of delivering a gas under control of the insufflator using a first line during the removing, stopping, measuring, comparing and continuing steps.

29. A method of operating a surgical vision and smoke evacuation system during separate operations of an insufflator, comprising:

delivering a gas at a first flow rate under control of a smoke evacuation system to an insufflated cavity using a first line connected to a medical instrument vision clearing system within the insufflated cavity maintained by an insufflator;

comparing the result of the measuring the pressure in the insufflated cavity step to a smoke evacuation set point using the smoke evacuation system controller to determine if the pressure in the insufflated cavity is above or below the smoke evacuation set point; and

continuing the stopping the removing gas step if the pressure in the insufflated cavity is below the smoke evacuation setpoint and resuming the removing gas from the insufflated cavity step if the pressure in the insufflated cavity is above the smoke evacuation set point.

30. A method for operating a smoke evacuation and vision clearing system, comprising: delivering gas at a base flow rate under control of a smoke evacuation system to an

insufflated cavity using a first line connected to a medical instrument vision clearing system within the insufflated cavity;

removing gas under control of the smoke evacuation system from the insufflated cavity using a second line connected to a trocar in communication with the insufflated cavity;

comparing the result of the measuring the pressure in the insufflated cavity step to a smoke evacuation set point using the smoke evacuation system controller to determine if the pressure in the insufflated cavity is above or below the smoke evacuation set point;

continuing the stopping the removing gas step if the pressure in the insufflated cavity is below the smoke evacuation setpoint and resuming the removing gas from the insufflated cavity step if the pressure in the insufflated cavity is above the smoke evacuation set point;

dispensing a lens clearing solution to the medical instrument vision clearing system while in use within the insufflated cavity;

delivering a gas under control of the smoke evacuation system at a burst flow rate to the first line connected to the medical instrument vision clearing system to assist in removal of the lens clearing solution and thereafter resume the step of delivering gas at the base flow rate.

31. The method of any of claims 26, 27, 28, 29, and 30 wherein the stopping step, the measuring step and the comparing steps are performed more than once a second.

32. The method of any of claims 26, 27, 28, 29, and 30 wherein the stopping step, the measuring step and the comparing steps are performed at least once every two seconds.

33. The method of any of claims 26, 27, 28, 29, and 30 wherein a subsequent sequence of performing the stopping step, the measuring step and the comparing steps is performed within five seconds of the immediately prior performance of the stopping, measuring and comparing steps.

34. A method of controlling pressure in an insufflated surgical cavity, comprising;

supplying an insufflation gas to an insufflator;

insufflating a surgical cavity by flowing in insufflation gas from the insufflator through a first trocar into the surgical cavity;

exhausting a gas from within the insufflated surgical cavity through a second trocar; providing the gas from the exhausting step to the insufflator;

adjusting the insufflating a surgical cavity step by adjusting the flow rate of the

insufflation gas to the first trocar based on a measured pressure of the gas from the exhausting step.

35. The method of claim 34 further comprising filtering the gas from the exhausting step to remove moisture or particles before the providing step.

36. The method of claim 34 further comprising stopping the exhausting a gas step and measuring a pressure of the surgical cavity using a line connected to the second trocar.

37. The method of claim 36 further comprising stopping the exhausting a gas step by closing a valve and measuring the pressure in the surgical cavity while the valve is closed.

38. A method of controlling pressure in an insufflated surgical cavity, comprising;

supplying and insufflation gas to an insufflator;

exhausting a gas from within the insufflated surgical cavity through a second trocar; measuring the pressure of the gas from the exhausting step;

insufflation gas to the first trocar based on the measuring the pressure of the gas from the exhausting step.

39. The method of claim 34 further comprising filtering the gas from the exhausting step to remove moisture or particles before the measuring step.

40. The method of claim 34 further comprising stopping the exhausting a gas step while performing the measuring the pressure step.

41. The method of claim 40 further comprising closing a valve to stop the exhausting a gas step and measuring the pressure in the surgical cavity while the valve is closed.

42. The method of claim 38 further comprising stopping the exhausting a gas step and measuring the pressure of the surgical cavity using a line connected to the second trocar.

43. The method of claim 42 further comprising stopping the exhausting a gas step by closing a valve and measuring the pressure in the line while the valve is closed.

44. The exhaust treatment system of any of claims 1 -7 further comprising computer readable instructions for performing any of the steps of any of the methods of claims 18-43.

45. The insufflator of any of claims 8-13 further comprising computer readable instructions for performing any of the steps of any of the methods of claims 18-43.

46. The insufflator of any of claims 14-17 further comprising computer readable instructions for performing any of the steps of any of the methods of claims 18-43.