Patent Publication Number: US-2022226557-A1

Title: Collection system for managing outflow from a surgical procedure

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The present application is a continuation application of U.S. patent application Ser. No. 16/985,631 filed Aug. 5, 2020. The entire contents of which are incorporated herein by reference. 
    
    
     FIELD 
     The disclosure relates generally to surgical systems and, more particularly, to a collection system for managing outflow from a gynecological surgical procedure. 
     BACKGROUND 
     Surgical procedures, such as tissue resection procedures, may be performed endoscopically within an organ, such as a uterus, by inserting an endoscope into the uterus and passing a tissue resection device through the endoscope and into the uterus. With respect to such endoscopic tissue resection procedures, it often is desirable to distend the uterus with a fluid, for example, saline, sorbitol, or glycine. The inflow and outflow of the fluid during the procedure maintains the uterus in a distended state and flushes tissue and other debris from within the uterus to maintain a visible working space. 
     SUMMARY 
     In accordance with aspects of the disclosure, a collection system for managing outflow from a gynecological surgical procedure includes a surgical instrument, a vacuum source, a first collection vessel, and a first fluid outflow line connected between the surgical instrument and the first collection vessel. The first fluid outflow line provides an outflow path for fluid from the surgical instrument to the first collection vessel. A first suction line is connected between the vacuum source and the first collection vessel. The first suction line provides suction to draw fluid from the surgical instrument to the first collection vessel. A surgical drape is positioned to collect liquid. A second fluid outflow line is connected between the surgical drape and a second collection vessel. The second fluid outflow line provides an outflow path for fluid from the surgical drape to the second collection vessel. A second suction line is connected with the second collection vessel. The second suction line provides suction to draw fluid from the surgical drape to the second collection vessel. A portion of the second suction line branches between a third suction line and a fourth suction line arranged in-parallel with the third suction line. The third suction line and the fourth suction line are each connected with the vacuum source. A flow restrictor is disposed along the third suction line. A valve is disposed along the fourth suction line. The valve is opened in a pulsatile fashion when fluid is present in the surgical drape to increase a level of suction provided to the surgical drape. 
     In some aspects of the disclosure, a sensor is connected with the third suction line and the valve. The sensor detects a presence of fluid in the surgical drape. The sensor opens the valve in the pulsatile fashion to suction fluid from the surgical drape to the second collection vessel. The sensor detects the presence of fluid in the surgical drape based on an increase in pressure in the third suction line. 
     In some aspects of the disclosure, opening or closing of the valve maintains at least some suction at the surgical instrument when fluid is present in the surgical drape. The valve remains closed when fluid is absent from the surgical drape. 
     In some aspects of the disclosure, the first suction line is coupled to the second suction line. 
     In some aspects of the disclosure, the amount of suction provided to the surgical drape when fluid is present in the surgical drape is less than a maximum suction level that can be provided by the vacuum source. 
     In some aspects of the disclosure, a first end of the second fluid outflow line is connected with a bottom of the surgical drape, and a second end of the second fluid outflow line is connected with a top of the second collection vessel. The second fluid outflow line suctions fluid against a force of gravity from the surgical drape to the second collection vessel. 
     In some aspects of the disclosure, an operating console operates the vacuum source. The operating console includes a display device. 
     Other features of the disclosure will be appreciated from the following description. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate aspects and features of the disclosure and, together with the detailed description below, serve to further explain the disclosure, in which: 
         FIG. 1  illustrates a collection system for managing outflow from a gynecological surgical procedure for use in accordance with the aspects and features of the disclosure; 
         FIG. 2  is a perspective view of a first portion of the collection system of  FIG. 1 ; and 
         FIG. 3  is a perspective view of a second portion of the collection system of  FIG. 1 . 
     
    
    
     DETAILED DESCRIPTION 
     As used herein, the term “distal” refers to the portion that is being described which is further from a user, while the term “proximal” refers to the portion that is being described which is closer to a user. Further, to the extent consistent, any of the aspects and features detailed herein may be used in conjunction with any or all of the other aspects and features detailed herein. 
     The term “about” as used herein may be inclusive of the stated value and means within an acceptable range of variation for the particular value as determined by one of ordinary skill in the art, considering tolerances (e.g., material, manufacturing, use, environmental, etc.) as well as the measurement in question and the error associated with measurement of the particular quantity (e.g., the limitations of the measurement system). For example, “about:” may mean within one or more standard deviations of the stated value. 
     Descriptions of technical features or aspects of an exemplary configuration of the disclosure should typically be considered as available and applicable to other similar features or aspects in another exemplary configuration of the disclosure. Accordingly, technical features described herein according to one exemplary configuration of the disclosure may be applicable to other exemplary configurations of the disclosure, and thus duplicative descriptions may be omitted herein. 
     Exemplary configurations of the disclosure will be described more fully below (e.g., with reference to the accompanying drawings). Like reference numerals may refer to like elements throughout the specification and drawings. 
     Referring to  FIG. 1  a surgical system provided in accordance with aspects of the disclosure is shown generally identified by reference numeral  100 . Surgical system  100  may include surgical system  200  described in more detail below with reference to  FIG. 2  and surgical system  300  described in more detail below with reference to  FIG. 3 . Surgical system  100  may include each of the surgical systems  200  and  300  that are each connected with a common control console  130  and a common vacuum source  101 . However, each of surgical systems  200  and  300  may operate as standalone systems. 
     The surgical system  100  is a collection system that may be employed for managing outflow from a gynecological surgical procedure. Surgical system  100  includes a surgical instrument  112  (e.g., a handpiece for gynecological procedures such as a hysteroscope, tissue resection instrument, etc.), a vacuum source  101 , a first collection vessel  150 , and a first fluid outflow line  180  connected between the surgical instrument  112  and the first collection vessel  150 . The first fluid outflow line  180  provides an outflow path for fluid from the surgical instrument  112  to the first collection vessel  150 . A first suction line  190  is connected between the vacuum source  101  and the first collection vessel  150 . The first suction line  190  provides suction to draw fluid from the surgical instrument  112  to the first collection vessel  150 . A surgical drape  110  is positioned to collect liquid. A second fluid outflow line  181  is connected between the surgical drape  110  and a second collection vessel  151 . The second fluid outflow line  181  provides an outflow path for fluid from the surgical drape  110  to the second collection vessel  151 . A second suction line  191  is connected with the second collection vessel  151 . The second suction line  191  provides suction to draw fluid from the surgical drape  110  to the second collection vessel  151 . The second suction line  191  branches between a third suction line  192  and a fourth suction line  193  arranged in-parallel with the third suction line  192 . The third suction line  192  and the fourth suction line  193  are each connected with the vacuum source  101 . A flow restrictor  194  is disposed along the third suction line  192 . A valve  195  is disposed along the fourth suction line  193 . 
     The valve  195  is opened, e.g., in a pulsatile fashion, when fluid is present in the surgical drape  110  to increase a level of suction provided to the surgical drape  110 . The valve  195  remains in a closed configuration when fluid is not present in the surgical drape  110 . 
     A first end  182  of the second fluid outflow line  181  is connected with a bottom  117  of the surgical drape  110 . A second end  184  of the second fluid outflow line  181  is connected with a top  152  of the second collection vessel  151 . The second fluid outflow line  181  provides a path for fluid to be suctioned from the surgical drape  110  to the second collection vessel  151 . 
     An operating console  130  operates the vacuum source  101 . The operating console  130  includes a display device  131 , such as a digital touch screen display. The valve  195 , flow restrictor  194 , sensor  196 , vacuum source  101 , and portions of the suction lines  190 ,  191 ,  192  and/or  193  can be located in the operating console  130 , or each of these components can be separate from the operating console  130 . 
     A sensor  196  is connected with the third suction line  192  and the valve  195 . The sensor  196  detects a presence of fluid in the surgical drape  110  based on an increase in pressure in the second suction line  192 . 
     The first suction line  190  may be at least partially coupled to the second suction line  191 . For example, at least one elastomeric band  197  or other suitable mechanical, e.g., clip, tie, etc., may secure the first suction line  190  to the second suction line  191 . 
     In use, the vacuum source  101  is configured to simultaneously provide suction to each of the surgical instrument  112  and the surgical drape  110 . However, the surgical drape  110  is generally open to atmosphere and an amount of suction provided to the surgical instrument  112  is generally not equal to the amount of suction provided to surgical drape  110 . Generally, when fluid is present at the surgical drape  110  an amount of suction provided to the surgical drape  110  increases to draw the fluid from the surgical drape  110  to the second collection vessel  151 . 
     As an example, a maximum amount of suction that can be provided by the vacuum source  101  may be about 300mmHG, which is distributed between the surgical instrument  112  and the surgical drape  110 . When fluid is not present in the surgical drape  110 , about 200mmHG of suction is provided to the surgical instrument  112 , while about 100mmHG of suction is provided to the surgical drape  110  via third suction line  192 . In this circumstance, the valve  195  remains closed and suction is not provided through fourth suction line  193 . However, when fluid is present in the surgical drape  110 , the valve  195  may be triggered to open and thus suction is provided through third suction line  192  and fourth suction line  193  in-parallel. Thus, when fluid is present in the surgical drape  110 , the distribution of suction is changed such that about 200mmHG of suction is provided to the surgical drape  110 , while about 100mmHG of suction is provided to the surgical instrument  112 . In this arrangement, some level of suction is always provided to each of the surgical drape  110  and the surgical instrument  112 . When fluid is present in the surgical drape  110 , the valve  195  is moved from a closed position to an open position, e.g., in a pulsatile fashion, such that the flow through fourth suction line  193  is “throttled” (i.e., repeatedly pulsed from a closed position to an open position) such that suction is simultaneously provided through each of suction lines  192  and  193 . Throttling the flow through the fourth suction line  193  increases the suction provided to the surgical drape (e.g., from about 100mmHG to about 200mmHG) while partially and temporarily reducing suction at the surgical instrument  112  (e.g., from about 200mmHG to about 100mmHG). This allows fluid to be drawn out of the surgical drape  110  to the second collection vessel  151  at an increased rate, while maintaining a sufficient level of suction at the surgical instrument  112 . 
     Referring to  FIG. 2  a surgical system provided in accordance with aspects of the disclosure is shown generally identified by reference numeral  200 . Surgical system  200  generally includes a surgical instrument  210 , a control console  230 , and a collection vessel  250 . Surgical system  200  further includes a cable  270 , outflow tubing  280 , and vacuum tubing  290 . 
     Surgical instrument  210  includes a surgical instrument such as tissue resecting handpiece  212  that may be configured as a reusable component and a tissue resecting end effector assembly  214  that may be configured as a single-use, disposable component. Handpiece  212  includes a housing  216  to facilitate grasping and manipulation of surgical instrument  210  by a user. Handpiece  212  further includes an output interface  218  configured to operably engage end effector assembly  214 , a motor  220  disposed within housing  216  and operably coupled to output interface  218  to drive output interface  218  and, thus, drive end effector assembly  214 , and a module dock  222  configured to mechanically engage and electrically coupled to a valve module  282  associated with outflow tubing  280 , as detailed below. Cable  270  electrically couples handpiece  212  and control console  230  with one another and, more specifically, electrically couples control console  230  with motor  220  to power and control operation of motor  220  and electrically couples control console  230  with valve module  282  to enable communication of, for example, identification, setting, and control information therebetween. In aspects of the disclosure, cable  270  is fixedly attached to handpiece  212  and releasably couplable with control console  230 , although other configurations are also contemplated. 
     End effector assembly  214  includes a proximal hub  224  configured to releasably engage housing  216  of handpiece  212  to releasably mechanically engage end effector assembly  214  with handpiece  212 . End effector assembly  214  further includes an outer shaft  226  extending distally from proximal hub  224  and a cutting shaft  228  extending through outer shaft  226 . A proximal end of cutting shaft  228  extends into proximal hub  224  wherein an input interface  229  is engaged with cutting shaft  228 . Input interface  229  is configured to operably couple to output interface  218  of handpiece  212  when proximal hub  224  is engaged with housing  216  such that, when motor  220  is activated to drive output interface  218 , input interface  229  is driven in a corresponding manner to thereby move cutting shaft  228  within and relative to outer shaft  226 . 
     Outer shaft  226 , as noted above, extends distally from proximal hub  224  and, in aspects of the disclosure, is stationary relative to proximal hub  224 , although other configurations are also contemplated. Outer shaft  226  may define a window (not shown) through a side wall thereof towards a distal end thereof to provide access to cutting shaft  228  which is rotatably and/or translatably disposed within outer shaft  226 . Cutting shaft  228  may define an opening (not shown) towards the distal end thereof providing access to the interior thereof and may include a serrated cutting edge (not shown) surrounding the opening, although other suitable cutting edge configurations are also contemplated. Alternatively, or additionally, outer shaft  226  may include a cutting edge defined about the window thereof. 
     Motor  220 , as noted above, is activated to move cutting shaft  228  and, more specifically, to drive rotation and/or translation of cutting shaft  228  relative to outer shaft  226 . Control console  230 , coupled to motor  220  via cable  270 , enables selective powering and controlling of motor  220  and, thus, selective rotation and/or translation of cutting shaft  228  relative to outer shaft  226  to resect tissue adjacent the distal end of end effector assembly  214 . 
     Continuing with reference to  FIG. 2 , a distal end  284  of outflow tubing  280  is coupled to proximal hub  224  of end effector assembly  214  in fluid communication with the interior of cutting shaft  228  and/or the interior of outer shaft  226  such that fluid, tissue, and debris drawn into cutting shaft  228  and/or outer shaft  226  may be suctioned, under vacuum, through end effector assembly  214  and outflow tubing  280 . A proximal end  286  of outflow tubing  280  is coupled to collection canister  250  to enable the fluid, tissue, and debris suctioned through end effector assembly  214  and outflow tubing  280  to be deposited within collection canister  250 . Distal end  284  of outflow tubing  280  may be fixedly secured to proximal hub  224  while proximal end  286  of outflow tubing  280  is configured to releasably couple to collection canister  250 , although other configurations are also contemplated. 
     Outflow tubing  280  further includes, as noted above, a valve module  282 . Valve module  282  is disposed between distal and proximal ends  284 ,  286 , respectively, of outflow tubing  280 . Valve module  282  includes a controllable valve  287  disposed within the flow path defined through outflow tubing  280  to selectively permit and inhibit flow therethrough and/or to control the flow rate therethrough, and a communication device  289 , e.g., a RFID tag, storing information regarding end effector assembly  214  such as, for example, identifying information, use setting information, etc. Valve module  282  is configured for releasable engagement with module dock  222  of handpiece in electrical communication therewith. With valve module  282  engaged with module dock  222  and, as detailed above, module dock  222  coupled to control console  230  via cable  270 , the information stored on communication device  289  of valve module  282  may be communicated to control console  230  (via a communication receiver, e.g., an RFID reader, of module dock  222  and cable  270 ) for use in controlling motor  220  to drive end effector assembly  214  in accordance with the settings, parameters, and/or other configuration thereof, and/or to control controllable valve  287 , e.g., in accordance with the activation/deactivation of motor  220 , the position and/or orientation of cutting shaft  228 , or in any other suitable manner. Thus, end effector assemblies  214  of various different configurations (different length, diameter, cutting arrangement, outflow tube configuration, etc.) may be utilized with handpiece  212  and control console  230  in a plug-and-play manner. 
     Referring still to  FIG. 2 , collection canister  250 , as noted above, is coupled to proximal end  286  of outflow tubing  280  to receive the fluid, tissue, and debris suctioned through end effector assembly  214  and outflow tubing  280 . Vacuum tubing  290  is coupled between collection canister  250  and a vacuum source (see, e.g., vacuum source  101  of  FIG. 1 ) disposed within or otherwise associated with control console  230  such that, upon activation of the vacuum source, negative pressure is established through collection canister  250 , outflow tubing  280 , and the interior of cutting shaft  228  and/or outer shaft  226  of end effector assembly  214  to draw the fluids, tissue, and debris into and through cutting shaft  228  and/or outer shaft  226 , outflow tubing  280 , and into collection canister  250 . 
     Control console  230 , as noted above, is configured to receive information from communication device  289  of valve module  282  and, based at least in part on that information, control motor  220  of handpiece  212 , control controllable valve  287  of valve module  282 , and operate the vacuum source thereof to resect tissue and suction resected tissue, fluid, and debris through end effector assembly  214  and outflow tubing  280  for depositing into collection canister  250 . Control console  230  generally includes an outer housing  232 , a touch-screen display  234  accessible from the exterior of outer housing  232 , a cable port  236  configured to receive cable  270 , and a vacuum tube port  238  configured to receive vacuum tube  290 . Outer housing  232  houses internal electronics (not shown) as well as the vacuum source. Control console  230  may be configured to connect to a mains power supply (not shown) for powering control console  230 . Further, control console  230  may be configured to receive user input, e.g., use information, setting selections, etc., via touch-screen display  234  or a peripheral input device (not shown) coupled to control console  230 . Operational input, e.g., ON/OFF signals, power level settings (HI power vs. LO power), etc., may likewise be input via touch-screen display  234  or a peripheral input device (not shown) such as, for example, a footswitch (not shown), a handswitch (not shown) disposed on handpiece  212 , etc. 
     In preparation for use, end effector assembly  214  is engaged with handpiece  212 , valve module  282  is engaged within module dock  222 , cable  270  is coupled to control console  230  (and handpiece  212  if not already connected thereto), proximal end  286  of outflow tubing  280  is coupled to collection canister  250  (and distal end  284  thereof to end effector assembly  214  if not already connected thereto), and vacuum tubing  290  is coupled between vacuum tube input  238  of control console  230  and collection canister  250 . The connections between valve module  282  and module dock  222  and between cable  270  and control console  2 , as detailed above, enable communication of information regarding end effector assembly  214  (and, in embodiments, outflow tubing  280 ) to control console  230  to enable control console  230  to adjust setting information, use parameters, etc., based thereupon. 
     In use, upon an activation input provided to control console  230 , control console  230  powers and controls motor  220  of handpiece  212  to, in turn, drive cutting shaft  228  of end effector assembly  214  to resect tissue adjacent the distal end of end effector assembly  214 . During activation, control console  230  also controls controllable valve  287  and the vacuum source disposed within control console  230  to suction fluid, the resected tissue, and debris through cutting shaft  228  and/or outer shaft  226 , outflow tubing  280 , and into collection canister  250 . 
     As demonstrated above, surgical system  200  provides a configuration whereby handpiece  212  and control console  230  remain isolated from the fluid, tissue, and debris suctioned through surgical instrument  210  and into collection canister  250 , thus facilitating the cleaning process for reuse of handpiece  212  and control console  230 . More specifically, while valve module  282  is coupled to module dock  222 , module dock  222  communicates signals (electrical and/or mechanical) to control controllable valve  287  of valve module  282  without requiring contact with the flow path through outflow tubing  280  and/or controllable valve  287 . End effector assembly  214  and outflow tubing  280 , on the other hand, may together be configured as a single-use component that is discarded after use. 
     Referring to  FIG. 3 , an outflow collection system provided in accordance with aspects of the disclosure is shown generally identified by reference numeral  300 . Outflow collection system  300  includes a surgical drape  310 , a fluid outflow line  320 , a collection vessel  350 , a suction line  390 , and a vacuum source, e.g., a control console  330  including a vacuum pump  331 . Outflow collection system  300  may further include one or more instrument lines (not shown) connected between one or more surgical instruments (not shown), e.g., an hysteroscope, a tissue resection device, etc., and the collection vessel  350  or an additional collection vessel. 
     Continuing with reference to  FIG. 3 , surgical drape  310  is positioned with a flap  314  thereof positioned underneath a patient “P,” e.g., between the patient “P” and the operating table “T,” with a funnel-shaped body  316  of the surgical drape  310  depending from the flap  314  and an end of the operating table “T.” The funnel-shaped body  316  defines an open, upper base end  317   a  configured to collect liquid, e.g., dripping out of the patient “P” and/or onto the operating table “T,” and a lower, apex end  317   b  that defines outflow opening  312 , through which the collected liquid is configured to flow. The distal end  384  of suction line  380  is connected to outflow opening  312 . 
     Suction line  380  extends to collection vessel  350  and is connected to a first port  332  of collection vessel  350 . Collection vessel  350  further includes a second port  334  configured to receive distal end  394  end of suction line  390 . The proximal end  392  of suction line  390  is coupled to a vacuum source, e.g., vacuum pump  331  of control console  330 , such that, upon activation of vacuum pump  331 , negative pressure is established through collection vessel  350  and fluid outflow line  380  to draw liquids collected in surgical drape  310  from surgical drape  310 , through fluid outflow line  380 , to collection vessel  350 . 
     The various embodiments disclosed herein may also be configured to work with robotic surgical systems and what is commonly referred to as “Telesurgery.” Such systems employ various robotic elements to assist the surgeon and allow remote operation (or partial remote operation) of surgical instrumentation. Various robotic arms, gears, cams, pulleys, electric and mechanical motors, etc. may be employed for this purpose and may be designed with a robotic surgical system to assist the surgeon during the course of an operation or treatment. Such robotic systems may include remotely steerable systems, automatically flexible surgical systems, remotely flexible surgical systems, remotely articulating surgical systems, wireless surgical systems, modular or selectively configurable remotely operated surgical systems, etc. 
     From the foregoing and with reference to the various figure drawings, those skilled in the art will appreciate that certain modifications can also be made to the disclosure without departing from the scope of the same. While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.