This invention relates generally to medical devices and methods and more particularly to devices and methods for removing smoke from a laparoscopic surgical field.
During a laparoscopic surgical procedure it is common for smoke to be created within the interior space in which the procedure is carried out (i.e., the “laparoscopic field” or “laparoscopic space”). The smoke can be created in various ways, e.g., by cauterization, laser incision, coagulation, vaporization, etc. In any case the smoke created can obscure the laparoscopic field for the surgeon, thereby making the laparoscopic procedure more difficult.
One technique for clearing the laparoscopic field of smoke is to use a trocar or other instrument extending into the field so that the positive pressure within the field will force the smoke out of the trocar and into a filter where the smoke will be collected. One such device using this passive smoke removal technique is the SeeClear® Surgical Smoke Evacuation System available from CooperSurgical, Inc. However, that passive smoke removal technique is not particularly effective due to the low positive pressure within the laparoscopic field, thereby rendering the smoke evacuation process somewhat slow and not as effective as possible. There are other devices currently available to actively withdraw the smoke from the laparoscopic field using a vacuum or suction. One such device is the Laparoshield Laparoscopic Smoke Filtration System sold by Pall Corporation. It consists of a device which is configured to be connected between a trocar or other device extending into the insufflated abdomen and to the hospital's vacuum or suction line. The device includes a manually operable button which the surgeon can press to couple the suction from hospital's suction line through the trocar to the laparoscopic field, whereupon the suction applied will draw the smoke out of the field. Since the level of suction provided by the hospital's suction line is significantly higher than the amount of suction required to clear smoke from the laparoscopic field, that device includes a bleed port in communication with the ambient air to reduce the level of suction applied when the button is pressed, otherwise the normal level of suction produced at the hospital's suction line would rapidly collapse the insufflated abdomen. Another smoke evacuation device utilizing the hospital's suction line is the PlumePort® ActiV® Laparoscopic Smoke Filtration Device available from Buffalo Filter, LLC. Still another smoke evacuation device utilizing the hospital's suction line is the PneuVIEW®XE smoke elimination system available from LEXION Medical, LLC. Coviden, AG provides a complex self-contained system, called the RapidVac™ Smoke Evacuator System, which is arranged for use with an electrosurgical generator to evacuate electrosurgical smoke and laser plume from a laparoscopic field.
While the above prior art may be generally suitable for the intended purpose of clearing smoke from a laparoscopic field, they each exhibit one or more of the following drawbacks, cost, complexity, effectiveness, efficiency and ease of use.
Thus, a need exists for a smoke evacuation system including a device which is low in cost, easy to use, automatic in operation, and effective for clearing smoke from a laparoscopic field. The subject invention addresses that need by providing a completely pneumatic, low cost (e.g., disposable) smoke evacuator regulator device which is configured for automatically and continuously removing smoke from a laparoscopic field.
One aspect of this invention is a smoke evacuator regulator device configured for coupling to a vacuum source for evacuating smoke from a laparoscopic field within the body of a patient, the laparoscopic field being insufflated with insufflation gas under positive pressure. The smoke evacuator regulator device is pneumatically-operated and configured to continuously monitor pressure of the gas within the laparoscopic field and to automatically apply suction from the vacuum source to the laparoscopic field when the pressure monitored reaches a set-point, whereupon smoke within the laparoscopic field is evacuated from the laparoscopic field.
In accordance with one preferred aspect of the smoke evacuator regulator device, it comprises a housing, a first device port, a second device port, a third device port and a valve. The first device port is located in the housing and configured for coupling to the laparoscopic field for monitoring the pressure of the gas in the laparoscopic field. The second device port is located in the housing and configured for coupling to the laparoscopic field for evacuating smoke from the laparoscopic field via the second device port. The third device port is located in the housing and configured for coupling to the vacuum source. The valve is located in the housing, is in a normally closed state and is coupled between the second device port and the third device port. The valve is operative in automatic response to the pressure of the gas monitored at the first device port, whereupon the valve opens to an open state to enable suction from the vacuum source to be applied through the third device port to the second device port when the pressure monitored at the first device port reaches the set-point, whereupon smoke within the laparoscopic field is evacuated from the laparoscopic field via the second device port and the third device port.
In accordance with another preferred aspect of the smoke evacuator regulator device of this invention, it additionally comprises a pressure chamber and a movable diaphragm. The pressure chamber is in fluid communication with the first port. The movable diaphragm forms a portion of the pressure chamber and is coupled to the valve. The movable diaphragm is biased to apply a bias force in opposition to pressure within the pressure chamber. The bias force establishes the set-point.
In accordance with another preferred aspect of the smoke evacuator regulator device of this invention, the bias force is adjustable.
In accordance with another preferred aspect of the smoke evacuator regulator device of this invention, the bias force is established by a spring.
In accordance with another preferred aspect of the smoke evacuator regulator device of this invention, the smoke evacuator regulator device comprises a housing, a diaphragm, a rotatable dial, an engagement member, a spring and a valve. The housing includes a pressure monitoring chamber, a first port, a second port, a third port. The pressure monitoring chamber is configured for fluid communication with the laparoscopic field via the first port, whereupon some of the insufflation gas is within the pressure monitoring chamber. The second port is configured for coupling to the laparoscopic field for evacuating smoke from the laparoscopic field via the second port. The third port is configured for coupling to the vacuum source. The diaphragm establishes a wall of the pressure monitoring chamber and is movable in response to a force applied thereto by the pressure of the insufflation gas within the pressure monitoring chamber. The rotatable dial is coupled to the housing and rotatable through an arc about a rotation axis between a first angular position and a second angular position, and vice versa, to establish an operating range for the smoke evacuator device. The engagement member is coupled to the rotatable dial and configured to cooperate with a stop member to adjust the operating range up or down to a desired operating range. The spring is coupled to the rotatable dial and configured to apply a bias force to the diaphragm in opposition to the force applied by the pressure of the insufflation gas within the pressure monitoring chamber. The bias force is adjustable within the desired operating range in response to rotation of the dial about the axis between the first angular position and the second angular position to establish the set-point. The set-point is adjustable within the desired operating range. The valve comprises a movable valve member and a valve seat in the housing. The valve is normally in a closed state isolating the second port from the third port. The movable valve member is connected to the movable diaphragm and movable therewith in automatic response to the pressure of the insufflation gas in the pressure monitoring chamber, whereupon the valve opens to an open state to enable suction from the vacuum source to be applied through the third port to the second port when the gas pressure monitored by the pressure monitoring chamber reaches the set-point, whereupon smoke within the laparoscopic field is evacuated from the laparoscopic field via the second port and the third port.
In accordance with another preferred aspect of the smoke evacuator regulator device of this invention, the stop member is located within the housing. The rotatable dial includes plural spaced apart openings extending in an arc about the rotation axis. The engagement member is configured to be located in any of one the openings to establish the desired operating range.
In accordance with another preferred aspect of the smoke evacuator regulator device of this invention, the stop member includes a first surface and a second surface, and wherein the engagement member is configured to engage the first surface at the first angular position and to engage the second surface at the second angular position.
In accordance with another preferred aspect of the smoke evacuator regulator device of this invention, the smoke evacuator regulator device additionally comprises a control pressure chamber within the housing configured to be at atmospheric pressure and defined between the rotatable dial and the diaphragm. The rotatable dial is configured to move toward the diaphragm by the rotation of the rotatable dial in a first rotational direction about the rotational axis and to move away from the diaphragm by the rotation of the dial in a second and opposite rotation direction. The spring is interposed between the rotatable dial and the diaphragm in the control pressure chamber, whereupon the bias force provided by the spring is increased upon rotation of the dial in the first rotational direction and the bias force provided by the spring is decreased upon rotation of the dial is the second and opposite rotational direction.
In accordance with another preferred aspect of the smoke evacuator regulator device of this invention, the housing comprises a base and a cap. The diaphragm is interposed between the base and the cap. The spring is interposed between the rotatable dial and the diaphragm. The rotatable dial is threadedly secured to the cap.
In accordance with another preferred aspect of the smoke evacuator regulator device of this invention, the spring comprises a helical compression spring having a longitudinal axis. The spring is interposed between the rotatable dial and a portion of the diaphragm, with the longitudinal axis of the spring being coaxial with the rotation axis.
In accordance with another preferred aspect of the smoke evacuator regulator device of this invention, the smoke evacuator regulator device additionally comprises a rotatable isolation disk interposed between the rotatable dial and the spring, whereupon rotation of the rotatable dial in either the first or second direction about the rotation axis does not cause the spring to rotate about the rotation axis.
In accordance with another preferred aspect of the smoke evacuator regulator device of this invention, the valve seat is formed of a resilient material. The movable valve member includes an end surface configured to engage the valve seat when the valve is in the normally closed state, and to be disengaged from the valve seat when the valve is in the open state.
In accordance with another preferred aspect of the smoke evacuator regulator device of this invention, the rotatable dial includes a detent mechanism for holding the rotatable dial at any rotational position establishing the set-point.
In accordance with another preferred aspect of the smoke evacuator regulator device of this invention, the detent mechanism comprises plurality of radially extending fins configured to be engaged by the engagement member to hold the rotatable dial at any rotational position establishing the set-point.
In accordance with another preferred aspect of the smoke evacuator regulator device of this invention, the smoke evacuator regulator device forms a portion of a system comprising a first tube, a second tube and a third tube. The first tube is configured to be connected to a first trocar extending into the laparoscopic field. The second tube is configured to be connected to a second trocar extending into the laparoscopic field. The third tube is configured to be connected to a canister which is connected to the vacuum source.
Another aspect of this invention is a system for evacuating smoke from a laparoscopic field within the body of a patient, the laparoscopic field being insufflated with insufflation gas under positive pressure. The system comprises a first instrument port in fluid communication with the laparoscopic field for monitoring the pressure of the gas in the laparoscopic field, a second instrument port in fluid communication with the laparoscopic field for evacuating smoke from the laparoscopic field via the second instrument port, and a smoke evacuator regulator device. The smoke evacuator regulator device comprises a housing, a first device port, a second device port, a third device port and a valve. The first device port is located in the housing and configured for coupling to the first instrument port for monitoring the pressure of the gas in the laparoscopic field. The second device port is located in the housing and configured for coupling to the second instrument port for evacuating smoke from the laparoscopic field via the second device port. The third device port is located in the housing and configured for coupling to the vacuum source. The valve is located in the housing and is in a normally closed state. The valve is coupled between the second device port and the third device port. The valve is operative in automatic response to the pressure of the gas monitored at the first device port, whereupon the valve opens to an open state to enable suction from the vacuum source to be applied through the third device port to the second device port when the pressure monitored at the first device port reaches a set-point, whereupon smoke within the laparoscopic field is evacuated from the laparoscopic field via the second device port and the third device port.
In accordance with one preferred aspect of the system of this invention, the smoke evacuator regulator device is pneumatically-operated and additionally comprises a pressure chamber and a movable diaphragm. The pressure chamber is in fluid communication with the first device port. The movable diaphragm forms a portion of the pressure chamber and is coupled to the valve. The movable diaphragm is biased to apply a bias force in opposition to pressure within the pressure chamber. The bias force establishes the set-point.
In accordance with another preferred aspect of the system of this invention, the bias force is adjustable.
In accordance with another preferred aspect of the system of this invention, the bias force is established by a spring.
In accordance with another preferred aspect of the system of this invention, the first instrument port forms a portion of a first instrument extending into the laparoscopic field, and wherein the second instrument port forms a portion of a second instrument extending into the laparoscopic field.
In accordance with another preferred aspect of the system of this invention, the first instrument is a trocar and wherein the second instrument is a trocar.
In accordance with another preferred aspect of the system of this invention, the laparoscopic field is confined, and wherein the system comprises a gel port and a smoke evacuating probe. The gel port includes the first instrument port, and another instrument port configured to be coupled to an insufflator supplying the insufflation gas under positive pressure to the laparoscopic field via the other instrument port. The gel port includes a penetrable portion. The second instrument port comprises a portion of the smoke evacuating probe. The smoke evacuating probe comprises an elongated needle and a one-way luer stop cock. The elongated needle has a longitudinal passageway extending therethrough. The one-way luer stop cock includes a luer connector and a movable lever. The luer connector is configured to be brought into fluid communication with the longitudinal passageway when the movable lever is moved to a predetermined position. The elongated needle is configured for penetrating the penetrable portion of the gel port.
Another aspect of this invention is a method of evacuating smoke from a laparoscopic field within the body of a patient, the field being insufflated with gas under positive pressure. The method comprises continuously monitoring pressure of the gas within the laparoscopic field via a first instrument port in fluid communication with the laparoscopic field. A pneumatically-operated smoke evacuator regulator device is coupled to a vacuum source and to a second instrument port in fluid communication with the laparoscopic field. Suction is automatically applied from the vacuum source to the laparoscopic field when the pressure monitored reaches a set-point, whereupon smoke within the laparoscopic field is evacuated from the laparoscopic field via the second instrument port and the vacuum source.
In accordance with one preferred aspect of the method of this invention, the pneumatically-operated smoke evacuator regulator device continuously monitors the pressure of the insufflation gas in the laparoscopic field via the first instrument port and the method additionally comprises coupling the pneumatically-operated smoke evacuator regulator device to a second instrument port in fluid communication with the laparoscopic field. A set-point for a desired pressure of the insufflation gas within the laparoscopic field is established. The pneumatically-operated smoke evacuator regulator device is operated to monitor the pressure of the insufflation gas in the laparoscopic field and automatically couples the second instrument port to the vacuum source when the pressure of the gas monitored in the laparoscopic field reaches the set-point, whereupon smoke within the laparoscopic field is evacuated from the laparoscopic field via the second instrument port and the vacuum source.
In accordance with another preferred aspect of the method of this invention, the laparoscopic field is confined and wherein the method additionally comprises providing a smoke probe including the second instrument port. The smoke probe is extended into the confined laparoscopic field. The smoke probe additionally comprises a valve and a thin elongated tubular member having a longitudinally extending passageway extending therethrough and terminating at an open distal end. The valve is interposed between the second instrument port and the longitudinally extending passageway. The open distal end of the smoke probe is disposed closely adjacent a source of smoke within the confined laparoscopic field. The valve is opened, whereupon smoke produced by the source of smoke is evacuated from the confined laparoscopic field via the smoke probe.
In accordance with another preferred aspect of the method of this invention, the first instrument port comprises a portion of a gel port configured for location within an opening in the body of the patient in communication with the laparoscopic field. The gel port includes a penetrable member, and wherein the method additionally comprises penetrating the penetrable member by the thin elongated tubular member of the smoke probe.
Referring now to the various figures of the drawing wherein like reference characters refer to like parts, there is shown in
The system 20 includes a smoke evacuator regulator device 22 constructed in accordance with this invention. The smoke evacuator regulator device 22 may also be referred to herein as a regulator device or a smoke evacuator device. In any case it is configured for coupling to a vacuum source, e.g., a hospital's suction line, to continuously evacuate the smoke 4 from the laparoscopic field. The regulator device 22 will be described in detail shortly. Suffice it for now to state that the regulator device includes three device ports, namely, a first device port 22A, a second device port 22B, and a third device port 22C. The first device port 22A is coupled to another trocar 16 via a flexible tube 16A. The trocar 16 is also a conventional device that includes a female luer connector 16B. The luer connector 16B is connected to one end of the flexible tube 16A by use of conventional male barbed connector 16C. An on-off valve (not shown) is located in the trocar 16 and is coupled to a pivotable lever 16D to either open or close the luer connector 16B, depending upon the rotational position of the lever. The trocar 16 extends into the laparoscopic field, e.g., the insufflated abdomen, to monitor the pressure of the gas therein. The second device port 22B is coupled to still another trocar 18 via a flexible tube 18A. The trocar 18 is also a conventional device that includes a female luer connector 18B. The luer connector 18B is connected to one end of the flexible tube 18A by use of conventional male barbed connector 18C. An on-off valve (not shown) is located in the trocar 18 and is coupled to a pivotable lever 18D to either open or close the luer connector 18B, depending upon the rotational position of the lever. The trocar 18 extends into the insufflated abdomen to serve as the means for evacuating the smoke 4 from the laparoscopic field. The third device port 22C is coupled to the vacuum source, e.g., the hospital's suction line, via a flexible tube 22D. In the exemplary system 20 shown in
As will be described in detail later the regulator device 22, when connected in the system 20 like shown in
The regulator device 22 basically comprises a housing 28, a dial 30 and a valve assembly (to be described later). The housing 28 includes a body or base 32, a cap 34, a diaphragm assembly 36, a string 38, a spring 40, a spring base 42, a set screw 44, and a valve assembly 46. The body or base 32 is best seen in
The cap 34 is a ring-like member formed of any suitable rigid material, e.g., ABS. It has an annular bottom section 34A which includes a helical internal thread 34B and an annular top section 34C which is of smaller external diameter than the bottom section and which includes a helical external thread 34D. The cap 34 is arranged to be screwed onto the body or base 32 to assemble the housing 28.
The diaphragm assembly 36 is best seen in
The internal threads 34B of the cap 34 are arranged to engage and screw onto the external threads 32C of the body or base 32 with the portion of the diaphragm disk 36A adjacent the periphery thereof tightly interposed between the cap and the body or base. In particular the annular ridge 36C of the disk 36A is located within the annular recess or groove 32J. Thus, when the cap is screwed onto the base the diaphragm disk closes off the chamber or cavity 32A, with the annular ridge tightly seated in the annular groove to form a good fluid-tight seal therebetween. The chamber or cavity 32A being coupled to the passageway 32I will thus be at the same positive pressure as existing within the laparoscopic field 10. Hence the chamber or cavity 32A will continuously monitor the pressure within the laparoscopic field 10.
The dial 30 is a circular disk-like member formed of any suitable rigid material, e.g., ABS. The dial is arranged to be rotated about the central longitudinal axis A of the housing 28 to establish a set point for the regulator device 22, i.e., the positive pressure level within the insufflated abdomen at which smoke will be evacuated. The dial has a downwardly extending peripheral sidewall 30A, the outer surface of which is ridged at 30B to provide a good gripping surface to enable the dial to be readily rotated about the axis A to the desired setting. The inner surface of the sidewall 30A includes a helical internal thread 30C which is configured to be screwed onto the external threads 34D of the cap. Thus, the dial can be rotated either clockwise or counterclockwise about the axis A to bring the undersurface of the cap either close to or further from the diaphragm assembly 36. With the dial screwed onto the housing, a cavity 30D is formed between the undersurface of the dial 30, the upper surface of the diaphragm 36A and the annular wall forming the top portion 34C of the cap 34. At least one aperture 30E is provided in the dial 30 in communication with the cavity 30D so that the pressure within the cavity is at atmospheric pressure. As best seen in
The diaphragm assembly 36 is configured to be biased to establish the heretofore mentioned set point for the device 22. In particular, a helical compression spring 40 is located within the cavity 30D interposed between a spring base 42 and the top surface of the diaphragm disk 36A. The spring base 42 is a disk-like member having a central hub portion 42A configured to fit closely within the top end of the spring 40. A set screw 44 extends through a bore 30F in the dial 30 centered on the axis A. As best seen in
As should be appreciated by those skilled in the art the presence of the disk base 42 decouples the rotation of the dial 30 from the spring 40. Thus, the rotation of the dial about the axis A does not result in the spring rotating with respect to the dial or to the diaphragm 36A, but does enable the spring to be compressed or decompressed (as the case may be) between the spring base and the diaphragm to whatever setting is desired to establish the set point for the regulator device 22. By decoupling of the spring from the dial one is able to ensure that the desired set point can be established and maintained accurately. In particular, the existence of the spring base 42 ensures that the spring will not be rotated with respect to the dial, upon rotation of the dial, since rotation of the spring if allowed could either coil the spring more tightly or uncoil the spring, depending upon the direction of rotation of the dial about the axis A. In either case rotation of the spring with respect to the dial will interfere with the normal operation of the spring. Moreover, the spring base 42 ensures that the spring will not rotate with respect to the diaphragm when the dial is rotated. This feature is also important, since rotation of the spring with respect to the diaphragm could apply a twisting action on the diaphragm, thereby interfering with its proper operation.
The valve assembly 46 basically comprises a movable valve member 46A and a stationary valve seat 46B. The movable valve member is in the form of piston having plural longitudinally extending ribs 46C terminating at a cone shaped lower end 46D. The string 38 is a very thin member formed of a flexible and relatively un-stretchable material, e.g. polyethylene. The upper end of the string is fixedly secured to the center stiffener 36B of the diaphragm assembly, with a mid-portion of the string passing through the aperture 32E, and with the bottom end of the string fixedly secured to the piston 46A. The valve seat 46B is a short section of a tube of any suitable resilient material, e.g., silicone, and includes a central passageway 46E. The valve seat 46B is fixedly secured within the passageway 32G at the bottom end thereof such that the bottom end of central passageway is at the port 22C. The conical lower end of the piston 46A is configured to be moved into engagement with the upper end of the valve seat 46B to close the valve and to be moved out of engagement with the upper end of the valve seat to open the valve. The movement of the valve member (piston) is accomplished by means of the string 38 which is connected to the diaphragm assembly. Thus, movement of the diaphragm disk 36A upward against the bias of the spring 40 will draw the string and the piston attached to it upward and out of engagement with the valve seat. Movement of the diaphragm downward will result in the movement of the piston downward and into engagement with the valve seat.
The amount of bias force provided by the spring 40 establishes the set point pressure at which the valve 46 opens. Thus, if the dial 30 is rotated to a position wherein the spring provides a bias force in excess of the force applied to the underside of the diaphragm 36A by the existing gas pressure within the cavity 32A (which is the pressure of the gas in the insufflated laparoscopic space), suction will not be applied to the laparoscopic field. However, once the dial is rotated to a position wherein the bias force applied by the spring is less than the force on the underside of the diaphragm, the diaphragm will flex upward against the bias of the spring thereby carrying the string and the valve member 46A upward off of the valve seat 46B, thereby opening the valve.
Use of the system 20 to evacuate smoke from the laparoscopic field is accomplished as follows. The dial 30 of the regulator device will be rotated to a desired position to establish a set point pressure at which the valve will open. That set point should be set to a pressure that is lower, e.g., 13 mm Hg, than the pressure of the insufflation gas, e.g., 15 mm Hg, supplied to the laparoscopic field by the insufflator. Thus, when the monitored pressure exceeds the set point (which will normally be the case since the set point is chosen to be less than the pressure of the insufflation gas) the valve 46A will automatically open to bring the passageway 32F and its associated port 22B into fluid communication with the passageway 32G and its associated port 22C. Accordingly, the suction applied at port 22C will draw smoke 4 from within the laparoscopic field through the trocar 18, the associated flexible tube 18A, and the port 22B to the vacuum source, thereby clearing the laparoscopic field of smoke.
The regulator device 22 operates continuously and automatically and limits the amount of pressure in the insufflated laparoscopic space to the set point pressure established by the rotational position of the dial 30. Thus, in the example above, if the insufflation pressure set by the insufflator is 15 mmHg and the set point of the device 22 is set to 13 mmHg, the amount of pressure existing within the laparoscopic space will be limited to 13 mmHg. This 13 mmHg pressure will be detected by the insufflator's pressure monitor (not shown) so that the insufflator will automatically attempt to raise the pressure within the laparoscopic field to the 15 mmHg to which the insufflator is set by pumping more gas at a faster rate into the laparoscopic field until the insufflator will be providing the maximum gas at the maximum rate. This action will continue as long as the insufflator is operating at its set point and the regulator device is operating at a lower set point, thereby resulting in the maximum rate of insufflation gas being introduced into the laparoscopic field and the concomitant maximum rate of evacuation of smoke from the laparoscopic field by the hospital's vacuum source.
It should also be noted that if the insufflator cannot keep up with the regulator device 22 to provide gas at the pressure set by the regulator device 22, e.g., 13 mmHg in the above example, the regulator device 22 will automatically stop. In particular, in such a case the pressure monitored by the port 22A will drop, whereupon the bias provided by the spring will overcome the bias provided by the pressure in the chamber 32A. This will cause the valve to close until the pressure within the chamber 32A again reaches the set point, e.g., 13 mmHg as the result of the insufflator pumping gas into the laparoscopic space. When that occurs, the valve will reopen to remove more smoke from the laparoscopic space. While such repeated opening and closing action will necessarily reduce the amount of smoke evacuated to the hospital's vacuum source, it will nevertheless prevent the laparoscopic field from being collapsed by the vacuum from that vacuum source. Thus, the regulator device 22 of the subject invention will enable whatever insufflator is used, be it a low flow rate insufflator or a high flow rate insufflator, to operate at its maximum capacity to insufflate the laparoscopic space with fresh gas while enabling smoke to be evacuated therefrom at the maximum rate that the insufflator is capable of achieving, thereby resulting in a visually clear laparoscopic space.
In the event that one of the trocars is removed from the laparoscopic field during operation of the system 20, or if there is a leak around one of the trocars extending into the laparoscopic field and the insufflator is not able to cope with the gas escaping through the aperture in the laparoscopic field at which leak is occurring or through which the trocar had extended, the system 20 will automatically shut down so that the hospital's vacuum source will not be applied to the laparoscopic field, thereby not exacerbating the collapse of the laparoscopic field.
When operation of the smoke evacuation system 20 is desired to be terminated, it can be accomplished easily. All that is required is to close the luer valve of the trocar 16 associated with the luer 16B by rotating the lever 16D or to close the luer valve of the trocar 18 associated with the luer 18B by rotating the lever 18D.
As mentioned above the cavity 32A includes four stand-offs 32D. These stand-offs serve to keep the area of the diaphragm against which the pressure of the gas entering into the cavity 32A constant irrespective the position of the diaphragm within that cavity. In particular, the stand-offs prevent the undersurface of the diaphragm portion 36D from resting directly on the bottom surface of the cavity 32. As should be appreciated by those skilled in the art, if the bottom surface of the diaphragm portion 36D was in direct contact with the bottom surface of the cavity that contact would decrease the available surface area of the diaphragm that the gas entering the cavity could act upon until the diaphragm lifts off of that surface, thereby interfering with the proper operation of the diaphragm assembly when the insufflation gas enters into that cavity via passageway 32I.
Turning now to
The gel port 100 is a conventional device used for laparoscopic procedures in confined spaces, like the rectum. One suitable gel port for that purpose is that sold by Applied Medical Resources Corporation under the trademark GelPort Laparoscopic System. The gel port basically comprises a body configured for introduction into an orifice of the patient, e.g., the patient's anus. The gel port has two luer ports 102A and 102B, each of which is in fluid communication with the laparoscopic field within the patient's body, e.g., the rectum. The gel port 100 also includes a penetrable or piercable wall 104 formed of gel through which small trocars or instruments can be inserted.
The systems 20 and 120 of this invention (and in fact any system constructed in accordance with this invention) require at least three ports to the laparoscopic field, one port through which the insufflation gas is introduced into the laparoscopic field, one port through which the pressure of the insufflation gas within the laparoscopic field is monitored, and one port through which the smoke is extracted. Since the gel port 100 only includes two ports 102A and 102B, the system 120 also includes a smoke probe 50 to serve as one of the three ports. In particular, in the exemplary embodiment of the system 120, the port 102A serves as the insufflation port and is thus connected to the insufflator via the flexible tube 12A. The port 102B being in fluid communication with the laparoscopic field serves as the pressuring monitoring port and thus is connected to the device port 22A via the flexible tube 16A. The smoke probe 50 serves as the smoke evacuation port and is inserted through the gel wall 104. The exemplary system 120 also includes the trocar 14 through which the instrument 2 extends. The trocar 14 of the system 120 will typically be a shorter length trocar than that used for laparoscopic procedures in a less confined laparoscopic field, e.g., the abdomen of a patient and will be inserted through the get wall 104.
As best seen in
Referring now to
The smoke evacuator regulator device 222, like the smoke evacuator regulator device 22, is pneumatically-operated and configured to continuously monitor pressure of the insufflation gas within the laparoscopic field 10 and to automatically apply suction from the vacuum source e.g., a hospital's suction line, to the laparoscopic field when the pressure monitored reaches a preset level or set-point, whereupon smoke 4 within the laparoscopic field is evacuated from the laparoscopic field. Thus, the device 222 can be thought of as a regulator providing a controlled leak of gas and smoke from the laparoscopic field when the device is operating at its set-point. The set-point is adjustable within a range of values. Moreover, as will be described later the range itself is adjustable. That feature facilitates calibration of the device after it has been assembled and during testing.
The construction of the device 222 will be described in detail shortly. Suffice it for now to state that it includes three device ports, namely, a first device port 222A, a second device port 222B, and a third device port 222C. The first device port 222A is coupled to another trocar 16 via a flexible tube 16A. The trocar 16 is also a conventional device that includes a female luer connector 16B. The luer connector 16B is connected to one end of the flexible tube 16A by use of conventional male barbed connector 16C. An on-off valve (not shown) is located in the trocar 16 and is coupled to a pivotable lever 16D to either open or close the luer connector 16B, depending upon the rotational position of the lever. The trocar 16 extends into the laparoscopic field, e.g., the insufflated abdomen, to monitor the pressure of the gas therein. The second device port 222B is coupled to still another trocar 18 via a flexible tube 18A. The trocar 18 is also a conventional device that includes a female luer connector 18B. The luer connector 18B is connected to one end of the flexible tube 18A by use of conventional male barbed connector 18C. An on-off valve (not shown) is located in the trocar 18 and is coupled to a pivotable lever 18D to either open or close the luer connector 18B, depending upon the rotational position of the lever. The trocar 18 extends into the insufflated abdomen to serve as the means for evacuating the smoke 4 from the laparoscopic field 10. The third device port 222C is coupled to the vacuum source, e.g., the hospital's suction line, via a flexible tube 22D. In the exemplary system 220 shown in
As will be described in detail later the smoke evacuator regulator device 222, when connected in the system 220 like shown in
The smoke evacuator regulator device 222 basically comprises a housing assembly 228, a dial 230, a movable valve member 232, a diaphragm 234, a spring 236, an engagement member 238, a stationary valve seat 240, a spring base 242, and an adapter 244. The housing assembly 228 includes a body or base 246 and a cap 248. The body or base 246 is best seen in
The bottom wall of the base 246 includes an upstanding tubular projection 256 having a central passageway 258 extending therethrough and in fluid communication with the pressure monitoring chamber. The central passageway is in communication with a radially extending passageway 260 in the body or base 246. The passageway 260 terminates at its outer end in a tubular section 262 which forms the port 222B. The body or base 246 includes another tubular section 264 having a passageway 266 therein and which projects outward from the base parallel to the tubular section 262. The passageway 266 is of a similar internal diameter as the passageway 260 and is in fluid communication with the pressure monitoring chamber 250. The tubular section 264 forms the port 222A. A tubular collar 268 projects downward from the bottom of the base 246 centered about the axis X. The interior of the collar 268 is in fluid communication with the central passageway 258. The collar serves to mount the adapter 244 thereon via a bayonet type connection to be described later. The adapter 244 will also be described later. Suffice it for now to state that the adapter serves to mount the valve seat 240 at the bottom of the passageway 258 to enable a portion of the valve 232 (to be described later) to engage the valve seat when the valve is closed. The adapter includes a central passageway 270 extending through it to form the port 222C.
The cap 248 is a ring-like member formed of any suitable rigid material, e.g., nylon or ABS. It has an annular bottom section 274 and an annular top section 276. The bottom section 274 includes a helical internal thread 278 configured to be threadedly engaged by the helical external thread 254 of the base 246 to mount the cap on the base. The annular top section 276 is of smaller external diameter than the bottom section 274 and includes a helical external thread 280. The thread 280 is arranged to be engaged by a mating helical internal thread 282 (to be described later) forming a portion of the dial 230 to mount the dial on the cap and enable the dial to be rotated with respect to the cap to bring the dial closer or further away from the cap to establish the desired set-point. The threads 280 and 282 are oriented in the opposite direction from a normal left-handed oriented screw thread, such that rotation of the dial 230 in the clockwise direction will move the dial further away from the cap 248, whereas rotation of the dial in the counter-clockwise direction will move the dial closer to the cap.
The diaphragm 234 is best seen in
The dial 230 is a circular cup-shaped member formed of any suitable rigid material, e.g., nylon or ABS. The dial is arranged to be rotated about the central longitudinal axis X (also referred to as the rotation axis) of the housing 228 to establish a set-point for the device 222, i.e., the positive pressure level within the insufflated abdomen at which smoke will be evacuated. The top of the dial is planar and has a downwardly extending circular peripheral sidewall 292, the outer surface of which is ridged at 294 to provide a good gripping surface to enable the dial to be readily rotated about the axis X either clockwise or counterclockwise to the desired set-point. The inner surface of the sidewall 292 includes the heretofore identified helical internal thread 282, which as discussed earlier is configured to be screwed onto the external threads 280 of the cap 248. Thus, the dial can be rotated either clockwise or counterclockwise about the axis X to bring the undersurface of the cap either closer to or further from the diaphragm 234. As best seen in
The movable valve member 232 is arranged to be moved between a closed state and an open state and vice versa. In the closed state the port 222B is isolated from the port 222C. In the open state the port 222B is in communication with the port 222C, whereupon suction at the port 222C will clear smoke within the insufflation field out of that field through the device 222. The valve member is best seen in
The diaphragm 234 is configured to be biased to establish the desired set-point for the device 222. To that end the spring 236, which is a helical compression spring, is located within the control pressure chamber 298 interposed between the spring base 242 and the head 306 of the valve member 232 as clearly shown in
The spring base 242 is best seen in
As should be appreciated by those skilled in the art the presence of the spring base 242 decouples the rotation of the dial 230 from the spring 236. Thus, the rotation of the dial about the axis X does not result in the spring rotating with respect to the dial, but does enable the spring to be compressed or decompressed (as the case may be) between the spring base and the head 306 of the valve member 232 to whatever setting is desired to establish the set-point for the device 222. By decoupling of the spring 236 from the dial 230 one is able to ensure that the desired set-point can be established and maintained accurately. In particular, the existence of the spring base 242 ensures that the spring will not be torqued or rotated with respect to the dial, upon rotation of the dial, since rotation of the spring if allowed could either coil the spring more tightly or uncoil the spring, depending upon the direction of rotation of the dial about the axis X. In either case rotation of the spring with respect to the dial will interfere with the normal operation of the spring. Moreover, the spring base 242 ensures that the spring will not rotate with respect to the diaphragm when the dial is rotated. This feature is also important, since rotation of the spring with respect to the head of the valve and the underlying portion of the diaphragm, which action could apply a twisting action on the diaphragm, thereby interfering with its proper operation.
The movement of the valve member 232 is effected by the movement of the diaphragm 234 under the force applied to the underside of the diaphragm by the pressure within the chamber 250 and against the bias provided by the spring 236. Thus, movement of the diaphragm upward against the bias of the spring will draw the flat end surface 308 of the valve member off of the valve seat 240 when the pressure applied to the underside of the surface reaches the set-point. As discussed above, the amount of bias force provided by the spring establishes the set-point pressure at which the valve opens. Thus, if the dial is rotated to a position wherein the spring provides a bias force in excess of the force applied to the underside of the diaphragm by the existing gas pressure within the chamber 250 (which is the pressure of the gas in the insufflated laparoscopic space), the bottom surface 308 of the valve member will be in engagement with the valve seat thereby isolating port 222C from port 222B so that suction will not be applied to the laparoscopic field. However, once the dial is rotated to a position wherein the bias force applied by the spring is less than the force on the underside of the diaphragm, the diaphragm will flex or otherwise move upward against the bias of the spring thereby carrying the valve member upward off of the valve seat, thereby opening the valve.
The dial 230 is rotatable through an arc A (
As mentioned earlier the cap includes a series of fins 326. Each fin is a thin blade-like member projecting inward radially from the inner surface of the top section 276. The fins are equidistantly spaced from one another, with the free end of each fin being located slightly beyond (inward of) the arc along which the adjustment holes 300A-300E are disposed. Accordingly, rotation of the dial about the axis X will bring the free end of the set-screw into engagement with the free ends of the fins as the dial is rotated in either rotational direction, whereupon the fin will flex and then snap back to its original shape thereby creating a clicking sound. The cooperation of the engagement member (set-screw 238) and the fins forms a detent mechanism. The detent mechanism ensures that when the rotation of the dial is stopped at any rotational position to establish the desired set-point, the dial will be retained in that rotational position by the engagement of the set-screw with the particular fin at that rotational position. As mentioned earlier, and in accordance with one preferred aspect of this invention, the operating range of the smoke evacuator regulator device 222 is adjustable up or down as a result of the position of the set-screw in any of the adjustment holes 300A-300E. In particular, the starting height position of the dial with respect to the cap 248 and the ending height position of the dial with respect to the cap, and hence the amount of bias provided by the spring 236, is established by the position of the set-screw 238 in any one of those adjustment holes. The particular hole that the set-screw is located in establishes the operating range for the device, i.e., the lowest set-point and the highest set-point. Irrespective of which adjustment hole the set-screw is located in, when the dial is in the start or down position the set-screw 238 will abut the start side 328 of the stop member 324 like shown in
The exemplary embodiment of the smoke evacuation regulator device 222 has an operating range of approximately 20 mmHg. Thus, the rotation of the dial in the clockwise direction from its “start” position to its “stop” position will reduce the set-point approximately 20 mmHg. Conversely, the rotation of the dial in the counterclockwise direction from its “stop” position to its “start” position will increase the set-point approximately 20 mmHg. The spacing of the adjustment holes 300A-300E with respect to one another establishes a difference of approximately 2 mmHg when the set-screw 238 is moved from one adjustment hole to an immediately adjacent adjustment hole. Thus, for example the positioning the set-screw in the hole 300A, like shown in
In practice, the smoke evacuator regulator device 222 will typically be set up to have an operating range of approximately 6 to 26 mmHg. To that end, when the device is assembled the set-screw 238 is located in the center adjustment hole 300C and then the device is tested and calibrated to make sure that it operates at that range and to adjust it up or down (calibrate it, if necessary) to operate in that range. In particular, with the set-screw in the center adjustment hole 300C the suction port 222C will be connected via tube 222D to a source of suction simulating the suction arrangement shown in
In short, the positioning of the set-screw from one adjustment hole to another of the adjustment holes results in the repositioning of the dial with respect to the base and a corresponding change in the compression of the spring. Even though the dial will be rotated through the same total angular rotation, i.e., through arc A, from the start position to the stop position the distance of the dial with respect to the cap will be changed and hence the range of compression or bias provided by the spring will be shifted up or down depending upon the adjustment hole into which the set-screw is placed.
Turning now to
As can be seen in
Use of the system 220 to evacuate smoke from the laparoscopic field is accomplished as follows. With the system set up like shown in
The smoke evacuator regulator device 222 operates continuously and automatically to limit the amount of pressure in the insufflated laparoscopic space to the set-point pressure established by the rotational position of the dial 230. Thus, in the example above, if the insufflation pressure set by the insufflator is 15 mmHg and the set-point of the device 222 is set to 12 mmHg, the amount of pressure existing within the laparoscopic space will be limited to 12 mmHg. This 12 mmHg pressure will be detected by the insufflator's pressure monitor (not shown) so that the insufflator will automatically attempt to raise the pressure within the laparoscopic field to the 15 mmHg to which the insufflator is set by pumping more gas at a faster rate into the laparoscopic field until the insufflator will be providing the maximum gas at the maximum rate. This action will continue as long as the insufflator is operating at its set-point and the regulator device is operating at a lower set-point, thereby resulting in the maximum rate of insufflation gas being introduced into the laparoscopic field and the concomitant maximum rate of evacuation of smoke from the laparoscopic field by the hospital's vacuum source.
It should also be noted that if the insufflator cannot keep up with the smoke evacuation regulator device 222 to provide gas at the pressure set by the device, e.g., 12 mmHg in the above example, the device will automatically stop. In particular, in such a case the pressure monitored by the port 222A will drop, whereupon the bias provided by the spring will overcome the bias provided by the pressure in the chamber 250. This will cause the valve to close until the pressure within the chamber 250 again reaches the set-point as the result of the insufflator pumping gas into the laparoscopic space. When that occurs, the valve will reopen to remove more smoke from the laparoscopic space. While such repeated opening and closing action will necessarily reduce the amount of smoke evacuated to the hospital's vacuum source, it will nevertheless prevent the laparoscopic field from being collapsed by the vacuum from that vacuum source. Thus, the smoke evacuation device 222 of the subject invention acts as controlled leak or regulate to enable whatever insufflator is used, be it a low flow rate insufflator or a high flow rate insufflator, to operate at its maximum capacity to insufflate the laparoscopic space with fresh gas while enabling smoke to be evacuated therefrom at the maximum rate that the insufflator is capable of achieving, thereby resulting in a visually clear laparoscopic space.
In the event that one of the trocars is removed from the laparoscopic field during operation of the system 220, or if there is a leak around one of the trocars extending into the laparoscopic field and the insufflator is not able to cope with the gas escaping through the aperture in the laparoscopic field at which leak is located or through which the trocar had extended, the system 220 will automatically shut down so that the hospital's vacuum source will not be applied to the laparoscopic field, thereby not exacerbating the collapse of the laparoscopic field.
When operation of the smoke evacuation system 220 is desired to be terminated, it can be accomplished easily. All that is required is to close the luer valve of the trocar 16 associated with the luer 16B by rotating the lever 16D or to close the luer valve of the trocar 18 associated with the luer 18B by rotating the lever 18D.
While not shown the system systems of this invention making use of a smoke evacuator regulator device 22 or 222 or any other regulator device constructed in accordance with this invention may include a component that displays or shows that the smoke evacuator system is actively pulling gas (smoke) from the laparoscopic field. That component may be a flow indicator or pressure indicator. The flow indicator can be located in two different locations, namely, between the trocar for evacuating the smoke and the regulator device or between the hospital vacuum source and the regulator device. A pressure indicator can only be located between the trocar for evacuating the smoke and the regulator device. In fact, it is contemplated that either the flow indicator or the pressure indicator be part of the regulator device, e.g., be to included in the housing at the appropriate port.
It should be pointed out that a regulator device in accordance with this invention can be constructed differently than the exemplary embodiments 22 and 222 described above, providing that it includes a port for monitoring the pressure with the laparoscopic field, an evacuation port configured for coupling to a vacuum source, and a valve for automatically coupling the vacuum source to the evacuation port when the monitored pressure within the laparoscopic field reaches a preset (set-point) level.
Without further elaboration the foregoing will so fully illustrate our invention that others may, by applying current or future knowledge, adopt the same for use under various conditions of service.
This utility application claims the benefit under 35 U.S.C. § 119(e) of Provisional Application Ser. No. 62/811,027 filed on Feb. 27, 2019, entitled System And Regulator Device For Evacuating Smoke From A Laparoscopic Field And Method Of Evacuating Smoke From A Laparoscopic Field. The entire disclosure of this provisional application is incorporated by reference herein.
Number | Date | Country | |
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62811027 | Feb 2019 | US |