Patent Description:
Surgical procedures, such as tissue resection procedures, may be performed endoscopically within an organ, such as a uterus, by inserting an endoscope (or hysteroscope) into the uterus and passing a tissue resection device through the endoscope and into the uterus. With respect to such hysteroscopic 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.

<CIT> discloses a tissue resection system including a collection container, a vacuum pump and a pressure sensor.

Provided in accordance with aspects of the present disclosure is a tissue resection system having improved fluid outflow management that lessens the start-up time of the tissue resection system and/or minimizes poor tissue resection performance (e.g., inadequate suction for fluid and tissue removal) due to low outflow pressure.

In an aspect of the present disclosure, a surgical fluid management system includes a surgical drape, a collection container, a fluid outflow tube coupled to the surgical drape and the collection container for withdrawal of exudate from the surgical drape into the collection container, and a valve disposed within the fluid outflow tube. The valve has a closed position for preventing flow into the collection container from the surgical drape and an open position for enabling flow through the surgical drape into the collection container.

The surgical fluid management system may further include a control console including a vacuum pump assembly and a vacuum line coupled to the vacuum pump assembly and the collection container for providing suction through the fluid outflow tube. The control console may control the valve.

The surgical drape may include a body defining a cavity therein, and a second end of the body may be coupled to the fluid outflow tube.

In another aspect of the present disclosure a surgical fluid management system includes a surgical drape including a body defining a cavity therein, a collection container, a fluid outflow tube coupled to the surgical drape and the collection container for withdrawal of exudate from the surgical drape into the collection container, and a membrane extending across the cavity of the surgical drape to close a fluid flow path between the surgical drape and the fluid outflow tube.

The membrane may be formed from a dissolvable or bioerodible polymer.

The surgical fluid management system may further include a control console including a vacuum pump assembly and a vacuum line coupled to the vacuum pump assembly and the collection container for providing suction through the fluid outflow tube.

In yet another aspect of the present disclosure, a surgical fluid management system includes an endoscope, a surgical drape, a first collection container, a second collection container, a first fluid outflow tube coupled to the endoscope and the first collection container for withdrawal of fluid from the endoscope into the first collection container, a second fluid outflow tube coupled to the surgical drape and the second collection container for withdrawal of fluid from the surgical drape into the second collection container, and a vacuum pump assembly including a vacuum line selector for controlling suction through the first and second fluid outflow tubes.

The surgical fluid management system may further include a first vacuum line coupled to the vacuum pump assembly and the first collection container for providing suction through the first fluid outflow tube, and a second vacuum line coupled to the vacuum pump assembly and the second collection container for providing suction through the second fluid outflow tube. The vacuum line selector may include a valve. In some aspects, the vacuum line selector is coupled to an actuator that is manually adjustable to open and close the first and second vacuum lines and, in other aspects, the vacuum line selector is motorized and programmed to automatically open and close the first and second vacuum lines.

In another aspect of the present disclosure, a surgical fluid management system includes an endoscope, a fluid source, a fluid inflow tube coupled to the endoscope and the fluid source for enabling delivery of fluid from the fluid source into the endoscope, a collection container, a fluid outflow tube coupled to the endoscope and the collection container for enabling withdrawal of fluid through the endoscope and into the collection container, and a pressure pump assembly including a pressure line selector for controlling pressure on the fluid source and in the collection container.

The surgical fluid management system may further include a first pressure line coupled to the pressure pump assembly and the fluid source for pressurizing fluid in the fluid source, and a second pressure line coupled to the pressure pump assembly and the collection container for drawing negative pressure through the collection container. The pressure line selector may include a valve for diverting pressure to the first or second pressure line. The pressure line selector may be motorized and programmed to automatically utilize either the first or second pressure line.

The surgical fluid management system may further include a vacuum pump assembly configured to establish negative pressure through the collection container. The pressure line selector may be configured to divert pressure into the second pressure line to aid the vacuum pump assembly in maintaining negative pressure in the collection container.

In still another aspect of the present disclosure, a tissue resection system includes a surgical instrument, a collection container, a fluid and debris outflow tube, a vacuum pump, and a vacuum line. The fluid and debris outflow tube is coupled to the surgical instrument and the collection container for withdrawal of fluid and debris through the surgical instrument and into the collection container. The vacuum pump assembly includes a vacuum pump and a vacuum monitoring assembly configured to monitor flow characteristics through the vacuum pump. The vacuum line is coupled to the vacuum pump assembly and the collection container for providing suction through the fluid and debris outflow tube.

The vacuum pump assembly may be a component of a control console. The control console may be configured to provide an alert when the vacuum monitoring assembly reads a threshold flow characteristic of the vacuum pump. The control console may prevent activation of the surgical instrument until the vacuum monitoring assembly reads a threshold flow characteristic of the vacuum pump. The threshold flow characteristic may be vacuum pressure.

The surgical instrument may include a handpiece and an end effector assembly releasably secured to the handpiece. The surgical instrument may include a valve disposed within the fluid and debris outflow tube. In some aspects, the valve is movable between a closed position when the vacuum monitoring assembly measures flow characteristics associated with air flow and an open position when the vacuum monitoring assembly measures flow characteristics associated with liquid flow. The valve may be a flow rate dependent valve. In other aspects, the valve is movable between a closed position when the end effector is not attached to the handpiece and an open position when the end effector is attached to the handpiece. The handpiece may include a communication receiver and the end effector assembly may include a communication device such that when the end effector assembly is attached to the handpiece, the communication device relays to the communication receiver that the end effector assembly is attached to the handpiece and the control console moves the valve to the open position. In some aspects, the valve is movable from a closed position when the surgical instrument is not activated for use and an open position when the surgical instrument is activated for use. The handpiece may include a drive mechanism therein, and the valve may be in electrical communication with the drive mechanism. The valve may be a motor-actuated valve or a pneumatically-actuated valve. In some aspects, the valve is coupled to an output interface of the handpiece. The valve may be a stopcock valve.

The handpiece of the surgical instrument may include a film disposed over and closing off an interface of the handpiece that connects with the end effector assembly, and when the end effector assembly is engaged with the handpiece, the film is opened.

Other aspects, as well as features, objects, and advantages of the aspects described in this disclosure will be apparent from the description and drawings, and from the claims.

Various aspects and features of the present disclosure are described hereinbelow with reference to the drawings wherein like numerals designate identical or corresponding elements in each of the several views.

Aspects of the present disclosure will now be described in detail with reference to the drawing figures wherein like reference numerals identify similar or identical elements. Throughout this description, the term "proximal" refers to a portion of a structure, or component thereof, that is closer to a user, and the term "distal" refers to a portion of the structure, or component thereof, that is farther from the user.

Referring now to <FIG>, a tissue resection system <NUM> in accordance with aspects of the present disclosure is shown. The tissue resection system <NUM> generally includes an endoscope <NUM>, a surgical drape <NUM>, a surgical instrument <NUM>, a control console <NUM>, a collection container <NUM>, and a fluid source <NUM>, as well as associated tubing (e.g., for fluid flow) and cables (e.g., for power).

The endoscope <NUM> is described herein as a hysteroscope configured for use within the uterus of a female patient. However, other suitable endoscopes and/or fluid-delivery devices are also contemplated for use in the tissue resection system <NUM> of the present disclosure on or within different anatomical structures. The endoscope <NUM> includes a body <NUM> and an elongate tube <NUM> extending distally from the body <NUM>. The body <NUM> includes an inflow valve <NUM>, an outflow valve <NUM>, and an arm <NUM> configured to connect to an imaging device (e.g., a camera) to capture images received via a visualization mechanism, e.g., optics (not shown), extending through the elongate tube <NUM>. The elongate tube <NUM> defines a first channel 115a for fluid inflow, a second channel 115b that is shared between fluid outflow and instrument access, e.g., for the surgical instrument <NUM>, and a third channel 115c housing the visualization mechanism (not shown). Alternatively, the first channel 115a is shared between fluid inflow and instrument access while the second channel 115b is dedicated to fluid outflow. The first channel 115a is coupled to the inflow valve <NUM> to enable the introduction of fluid through the endoscope <NUM> and into a patient. A fluid inflow tube <NUM> is coupled to the inflow valve <NUM> and the fluid source <NUM> for enabling the delivery of fluid from the fluid source <NUM> into the endoscope <NUM>, and thus, ultimately into the patient. The second channel 115b is coupled to the outflow valve <NUM> to enable the withdrawal of fluid from the patient through the endoscope <NUM>. A fluid outflow tube <NUM> is coupled to the outflow valve <NUM> and the collection container <NUM> for enabling the withdrawal of fluid from the patient into the endoscope <NUM> and into the collection container <NUM>.

The fluid outflow tube <NUM> is also connected to the surgical drape <NUM> for collecting exudate (e.g., body fluid, tissue, etc.) from the patient into the collection container <NUM>. The fluid outflow tube <NUM> is a y-shaped tube having a main line 124a coupled to the collection container <NUM> that splits into two branch lines 124b, 124c (also referred to herein as an endoscope line and a drape line, respectively), with the endoscope line 124b coupled to the inflow valve <NUM> of the endoscope <NUM> and the drape line 124c coupled to the surgical drape <NUM>. Alternatively, the endoscope and drape lines 124b, 124c may separately connect to collection container <NUM>.

The surgical drape <NUM> has a body <NUM> including first and second ends 132a, 132b and defining a cavity <NUM> therein. The body <NUM> may have a generally funnel shape such that the first end 132a has a larger dimension than the second end 132b. The first end 132a is configured for positioning beneath a patient and catching the exudate released from the patient, and the second end 132b is coupled to the drape line 124c of the fluid outflow tube <NUM>, as described above.

The surgical instrument <NUM> is described herein as a tissue resecting device, however, other suitable surgical instruments are also contemplated for use in the system <NUM> of the present disclosure. The surgical instrument <NUM> generally includes a handpiece <NUM> and an end effector assembly <NUM> extending distally from the handpiece <NUM>. The end effector assembly <NUM> is configured to releasably engage the handpiece <NUM>. In aspects, the handpiece <NUM> is a reusable component and the end effector assembly <NUM> is a single-use disposable component. The handpiece <NUM> supports a drive mechanism <NUM> therein. The drive mechanism <NUM> includes a motor 146a that is operably coupled to the end effector assembly <NUM> to effect a function of the end effector assembly <NUM>. The drive mechanism <NUM> is adapted to connect to the control console <NUM> via a cable <NUM> for powering and controlling the motor 146a. An actuator <NUM>, shown in the form of a foot pedal, is coupled to the drive mechanism <NUM>, via the control console <NUM>, by a cable <NUM> for enabling the selective activation of the surgical instrument <NUM>. Handswitches on the handpiece <NUM> are alternatively or additionally contemplated.

The end effector assembly <NUM> includes hub <NUM>, a shaft <NUM> extending distally from the hub <NUM>, and a cutting tool <NUM> extending through the shaft <NUM>. The shaft <NUM> defines a window <NUM> through a side wall thereof at a distal end portion 152a of the shaft <NUM> to provide access to the cutting tool <NUM> which is rotatably and/or translatably disposed within the shaft <NUM> and operably coupled to the drive mechanism <NUM>. The cutting tool <NUM> defines an opening <NUM> providing access to the interior thereof and may include serrated cutting edges <NUM> surrounding the opening <NUM>, although other suitable cutting and/or shaving edge configurations are contemplated.

A fluid and debris outflow tube <NUM> is coupled to the cutting tool <NUM> and extends through the handpiece <NUM> to the collection container <NUM> for enabling the withdrawal of fluid (e.g., fluid from the fluid source <NUM>, body fluids, etc.) and debris (e.g., resected tissue, etc.) suctioned from the patient through the cutting tool <NUM> and into the collection container <NUM>. The fluid and debris outflow tube <NUM> is operably coupled with a vacuum pump assembly <NUM> (<FIG>) of the control console <NUM> to enable suctioning of the fluid and debris through the cutting tool <NUM> and into the collection container <NUM>.

As shown in <FIG>, in conjunction with <FIG>, the control console <NUM> includes a controller assembly <NUM> and a display <NUM>. The controller assembly <NUM> is configured to control the display of information on the display <NUM> and may be configured to receive and process information inputted thereto (e.g., via a touch-screen of the display <NUM>). The control console <NUM> supports a motor control assembly <NUM> therein that is configured to control the drive mechanism <NUM> of the surgical instrument <NUM>, a power supply <NUM> configured to convert power from a main power supply <NUM> into suitable form for powering the control console <NUM>, a vacuum pump assembly <NUM> configured to control suction through the endoscope <NUM>, the surgical drape <NUM>, and the surgical instrument <NUM>, and, in aspects, a pressure pump assembly <NUM> configured to pressurize the fluid source <NUM> supplied to the endoscope <NUM>. The components of the control console <NUM> include suitable hardware and may also include one or more processors and associated memories storing software to be executed by the processors to control the hardware components (although one or more centralized processors and/or memories may alternatively be provided).

A vacuum line <NUM> (e.g., vacuum tubing) is coupled to the vacuum pump assembly <NUM> and the collection container <NUM> for establishing negative pressure through the collection container <NUM> and thus, through the fluid outflow tube <NUM> and the fluid and debris outflow tube <NUM> to ultimately draw fluid and debris from the endoscope <NUM>, the surgical drape <NUM>, and the surgical instrument <NUM> into the collection container <NUM>. A pressure line <NUM> is coupled to the pressure pump assembly <NUM> and the fluid source <NUM>. The pressure line <NUM> includes a cuff <NUM> (<FIG>) positioned around the fluid source <NUM> for pressurizing the fluid therein.

With continued reference to <FIG>, the collection container <NUM> defines a chamber <NUM> therein and includes a plurality of ports <NUM> in fluid communication with the chamber <NUM>. The fluid outflow tube <NUM> and the fluid and debris outflow tube <NUM> are coupled to the ports <NUM> to enable passage of fluid and debris into the chamber <NUM>, and the vacuum line <NUM> is also coupled to one of the ports <NUM> to draw vacuum therethrough. In some aspects, the tissue resection system <NUM> includes a plurality of collection containers <NUM>, and in certain aspects, the control console <NUM> includes a support (not shown) for supporting the collection container(s).

The fluid source <NUM> is a fluid bag containing a fluid, e.g., saline, sorbitol, or glycine, therein. It should be understood that other configurations of the fluid source <NUM> are envisioned. The fluid source <NUM> is connected to the fluid inflow tube <NUM> which, as described above, is coupled to inflow valve <NUM> of the endoscope <NUM> for enabling delivery of fluid from the fluid source <NUM> to the endoscope <NUM>. The cuff <NUM> of the pressure line <NUM> is disposed around the fluid source <NUM> to pressurize the fluid therein and drive the fluid through the fluid inflow tube <NUM> and the endoscope <NUM> and, ultimately, into the patient. In some aspects, the tissue resection system <NUM> includes a plurality of fluid sources <NUM> and, in certain aspects, the control console <NUM> includes a support (e.g., support pole <NUM>) for supporting the fluid source(s) <NUM>. In aspects, the control console <NUM>, the fluid source(s) <NUM>, the collection container(s) <NUM>, and/or other components (e.g., the actuator <NUM>) are assembled together, such as, on a cart.

In use, the user activates the control console <NUM> to start up and prime the tissue resection system <NUM> for use. Upon activation, the vacuum pump assembly <NUM> establishes negative pressure through the collection container <NUM> to control suction through the endoscope <NUM>, the surgical drape <NUM>, and the surgical instrument <NUM>. During start-up, the endoscope <NUM>, the surgical drape <NUM>, and the surgical instrument <NUM> may be open to the atmosphere (e.g., there is no or minimal fluid in the tissue resection system <NUM>) which results in suctioning of air therethrough. This can lead to loss of suction or a delay in generating adequate vacuum pressure in the tissue resection system <NUM> which is needed to facilitate tissue removal and inhibit uterus collapse. In order to establish adequate vacuum pressure for optimal performance of the tissue resection system <NUM> and/or to minimize the start-up time for reaching a threshold vacuum pressure for use, the tissue resection system <NUM> includes one or more of the following fluid outflow management features.

As shown in <FIG>, the vacuum pump assembly <NUM> includes a vacuum pump 170a and a vacuum monitoring assembly 170b configured for monitoring flow characteristics (e.g., vacuum pressure, flow rate, flow resistance, etc.) through the vacuum pump 170a. The vacuum pump assembly <NUM> may adjust the operating parameters of the vacuum pump 170a based on the flow characteristics (e.g., vacuum pressure readings) measured by the vacuum monitoring assembly 170b. The control console <NUM> is configured to provide an alert (e.g., a visual or audible alert) on the display <NUM> to the user when sufficient vacuum pressure is achieved (e.g., the vacuum monitoring assembly 170b reads a threshold vacuum pressure suitable for use) and the tissue resection system <NUM> is ready for use and/or that there is insufficient vacuum pressure and the tissue resection system <NUM> is not ready for use. In some aspects, the control console <NUM> is configured to prevent activation of the surgical instrument <NUM> (<FIG>) until optimal flow characteristics (e.g., a threshold vacuum pressure) is achieved for use of the tissue resection system <NUM>.

As shown in <FIG>, the surgical instrument <NUM> includes a valve <NUM> to aid in establishing or maintaining adequate operating vacuum pressure in the tissue resection system <NUM> in accordance with an aspect of the present disclosure. The valve <NUM> is disposed within the handpiece <NUM> of the surgical instrument <NUM> and is coupled to the fluid and debris outflow tube <NUM> to control the flow of fluid and debris therethrough. The valve <NUM> is disposed within the flow path of the fluid and debris outflow tube <NUM> to selectively permit and inhibit flow therethrough and/or to control the flow rate therethrough. Accordingly, the valve <NUM> is movable between a closed position for inhibiting flow through the fluid and debris outflow tube <NUM> and an open position for enabling free flow through the fluid and debris outflow tube <NUM>, and may include one or more partially open positions for enabling partial flow through the fluid and debris outflow tube <NUM>.

In aspects, the valve <NUM> is a flow rate dependent valve that prevents or reduces flow through the fluid and debris outflow tube <NUM> when air is sensed in the tissue resection system <NUM> and adjusts to enable full flow therethrough once liquid is sensed in the tissue resection system <NUM>. In some aspects, the flow rate through the valve <NUM> is controlled mechanically therein by, for example, a diaphragm, a flap, or a membrane disposed within the valve <NUM> that moves between the open and closed positions in response to the amount of vacuum pressure within the fluid and debris outflow tube <NUM>. In other aspects, the valve <NUM>, e.g., as a solenoid or other electrically-controlled valve, is controlled by the control console <NUM> (<FIG>) through an electrical connection via the cable <NUM> connecting the handpiece <NUM> to the control console <NUM>. The control console <NUM> moves the valve <NUM> between the open and closed positions in response to the flow characteristics read by the vacuum monitoring assembly 170b (<FIG>). The valve <NUM> is moved to the closed position or a partially open position when the vacuum monitoring assembly 170b reads flow characteristics associated with air flow and is moved to the open position when the vacuum monitoring assembly 170b reads flow characteristics associated with liquid flow.

As shown in <FIG>, the surgical instrument <NUM> includes a valve <NUM>' to aid in establishing or maintaining adequate operating vacuum pressure in the tissue resection system <NUM> in accordance with another aspect of the present disclosure. The valve <NUM>' is disposed within the handpiece <NUM> of the surgical instrument <NUM> and is coupled to the fluid and debris outflow tube <NUM> to control the flow of fluid and debris therethrough. The valve <NUM>' is disposed within the flow path of the fluid and debris outflow tube <NUM> to selectively permit and inhibit flow therethrough and/or to control the flow rate therethrough. Accordingly, the valve <NUM>' is movable between a closed position for inhibiting flow through the fluid and debris outflow tube <NUM> and an open position for enabling free flow through the fluid and debris outflow tube <NUM>.

The valve <NUM>' is in the closed position when the end effector assembly <NUM> is not attached to the handpiece <NUM> and is moved to the open position when the end effector assembly <NUM> is attached to the handpiece <NUM>. The handpiece <NUM> includes a communication receiver 143a, e.g., an RFID reader, disposed therein and the end effector assembly <NUM> includes a communication device 143b, e.g., an RFID tag, in the hub <NUM> thereof for storing information regarding the end effector assembly <NUM>, such as, for example, identifying information, use setting information, etc. Upon attachment of the end effector assembly <NUM> with the handpiece <NUM>, the communication device 143b is disposed in contact with or sufficient proximity relative to the communication receiver 143a to enable the communication receiver 143a to read information from the communication device 143b and relay the same to the control console <NUM>. Specifically, the communication device 143b relays that the end effector assembly <NUM> is attached to the handpiece <NUM> and the control console <NUM> opens the valve <NUM>' to establish flow through the fluid and debris outflow tube <NUM>. Alternatively, the valve <NUM>' may be disposed in a distal end of the handpiece <NUM> such that the valve <NUM>' is opened manually upon attachment of the end effector assembly <NUM> to the handpiece <NUM>, e.g., via a portion of the end effector assembly <NUM> physically contacting (directly or indirectly) and manipulating (directly or indirectly) the valve <NUM>'.

During start-up, the end effector assembly <NUM> remains separate from the handpiece <NUM> so that the valve <NUM>' remains closed and the flow of ambient air through the handpiece <NUM> is prevented. The end effector assembly <NUM> is attached to the handpiece <NUM> after the tissue resection system <NUM> is primed and ready for use (e.g., as one of the last steps of the start-up process to minimize the amount of ambient air entered in the tissue resection system <NUM>).

As shown in <FIG>, the surgical instrument <NUM> includes a valve <NUM>" to aid in establishing or maintaining adequate operating vacuum pressure in the tissue resection system <NUM> in accordance with another aspect of the present disclosure. The valve <NUM>" is disposed within the handpiece <NUM> of the surgical instrument <NUM> and is coupled to the fluid and debris outflow tube <NUM> to control the flow of fluid and debris therethrough. The valve <NUM>" is disposed within the flow path of the fluid and debris outflow tube <NUM> to selectively permit and inhibit flow therethrough and/or to control the flow rate therethrough. Accordingly, the valve <NUM>" is movable between a closed position for inhibiting flow through the fluid and debris outflow tube <NUM> and an open position for enabling free flow through the fluid and debris outflow tube <NUM>.

The valve <NUM>" is in the closed position when the surgical instrument <NUM> is not in use and moves to the open position when the surgical instrument <NUM> is activated for use (e.g., by depressing the foot pedal <NUM> (<FIG>)). The valve <NUM>" is electrically coupled to the drive mechanism <NUM> of the handpiece <NUM> such that upon activation of the surgical instrument <NUM>, the drive mechanism <NUM> sends a signal to open the valve <NUM>". In some aspects, the valve <NUM>" is a motor-actuated valve, in some other aspects, the valve <NUM>" is a pneumatically-actuated valve, and in still other aspects, the valve <NUM>" is an electrically-actuated valve.

As shown in <FIG>, the surgical instrument <NUM> includes a valve <NUM>‴ to aid in establishing or maintaining adequate operating vacuum pressure in the tissue resection system <NUM> in accordance with yet another aspect of the present disclosure. The valve <NUM>‴ is coupled between an output interface of the handpiece <NUM> and the fluid and debris outflow tube <NUM> such that the valve <NUM>‴ is disposed outside of the surgical instrument <NUM> and is manually adjustable by a user. The valve <NUM>‴ is disposed within the flow path of the fluid and debris outflow tube <NUM> to selectively permit and inhibit flow therethrough and/or to control the flow rate therethrough. Accordingly, the valve <NUM>‴ is movable between a closed position for inhibiting flow through the fluid and debris outflow tube <NUM> and an open position for enabling free flow through the fluid and debris outflow tube <NUM>. In some aspects, the valve <NUM>‴ is a stopcock, however, other forms of valves for manually regulating fluid flow are envisioned.

In use, the valve <NUM>‴ is positioned in the closed position while the tissue resection system <NUM> is not in use and during start-up to prevent the flow of ambient air through the surgical instrument <NUM>. Once the tissue resection system <NUM> is primed and ready for use, the valve <NUM>‴ is turned to the open position to enable free flow through the fluid and debris outflow tube <NUM>. The control console <NUM> (<FIG>), based on the operating status of the system <NUM>, may provide a visual, audible, and/or other output indicating the position of the valve <NUM>‴ and/or when the valve <NUM>‴ should be manipulated to the other position.

As shown in <FIG>, the handpiece <NUM> of the surgical instrument <NUM> includes a film <NUM> covering the interface of the handpiece <NUM> that connects with the end effector assembly <NUM> (<FIG>). The film <NUM> may be applied to the handpiece <NUM> prior to start-up of the tissue resection system <NUM> (<FIG>) by the manufacturer, after sterilization procedures, and/or in the operating room. During start-up, the handpiece <NUM> remains separated from the end effector assembly <NUM> so that the film <NUM> remains intact and closes off the interior of the handpiece <NUM> to prevent or minimize the flow of ambient air into the tissue resection system <NUM>. It is noted that, in an initial position, the flow path through the end effector assembly <NUM> (<FIG>) may also be closed, e.g., wherein the opening <NUM> of the cutting tool <NUM> is offset from the window <NUM> of the shaft <NUM> (<FIG>), to prevent or minimize the flow of ambient air therethrough. Once the tissue resection system <NUM> is primed and ready for use, the film <NUM> is opened (e.g., pierced during attachment of the end effector assembly <NUM> (<FIG>) to the handpiece <NUM> or removed just prior to attaching the end effector assembly <NUM> to the handpiece <NUM>) to enable fluid flow through the surgical instrument <NUM>. Accordingly, the end effector assembly <NUM> is attached to the handpiece <NUM> as one of the last steps of the start-up process.

As shown in <FIG>, the surgical drape <NUM> may include a valve <NUM> associated therewith to aid in establishing or maintaining adequate operating vacuum pressure in the tissue resection system <NUM> in accordance with an aspect of the present disclosure. The valve <NUM> is disposed between the surgical drape <NUM> and the fluid outflow tube <NUM> to control the flow of fluid and debris therethrough. The valve <NUM> is disposed within the flow path of the fluid outflow tube <NUM> to selectively permit and inhibit flow therethrough and/or to control the flow rate therethrough. Accordingly, the valve <NUM> is movable between a closed position for inhibiting flow through the fluid outflow tube <NUM> and an open position for enabling free flow through the fluid outflow tube <NUM>.

In some aspects, the valve <NUM> is manually adjustable by a user. The valve <NUM> may be a stopcock, however, other forms of valves for manually regulating fluid flow are envisioned. In use, upon start-up of the tissue resection system <NUM> (<FIG>), the valve <NUM> is disposed in the closed position to prevent the suctioning of ambient air through the surgical drape <NUM>. Once the tissue resection system <NUM> is primed for use, the valve <NUM> is turned to the open position to enable flow from the surgical drape <NUM>, through the fluid outflow tube <NUM>, and into the collection container <NUM> (<FIG>).

In other aspects, the valve <NUM> is controlled by the control console <NUM> (<FIG>). The valve <NUM> may be a motorized valve that is electrically connected to the control console <NUM> (<FIG>). In use, the valve <NUM> is closed by the control console <NUM> to prevent suctioning of ambient air through the surgical drape <NUM>. Once the tissue resection system <NUM> (<FIG>) is primed for use, the control console <NUM> sends a signal to open the valve <NUM> and to enable flow through the surgical drape <NUM> and the fluid outflow tube <NUM> into the collection container <NUM> (<FIG>).

As shown in <FIG>, the surgical drape <NUM> may include a membrane <NUM> extending across the cavity <NUM> defined in the body <NUM> thereof to close surgical drape <NUM> and prevent ambient air from being pulled therethrough. While the membrane <NUM> is shown as extending across the second end 132b of the body <NUM> of the surgical drape <NUM>, it should be understood that the membrane <NUM> may extend across any portion within the cavity <NUM> or across the first end 132a of the body <NUM> so long as the membrane <NUM> closes the entrance of the surgical drape <NUM> into the fluid outflow tube <NUM>. The membrane <NUM> may be formed from a dissolvable or bioerodible polymer, such as a water soluble polymer, or a biopolymer, such as sugars, starches, or salts, such that the membrane <NUM> dissolves, erodes, deforms, or otherwise drops off after a predetermined amount of fluid contacts the membrane <NUM>, thereby opening the surgical drape <NUM> and enabling exudate to be removed therefrom. Alternatively, the membrane <NUM> may be formed from any material that may pierced or removed by a user once adequate vacuum pressure is established in the tissue resection system <NUM>.

As shown in <FIG>, a tissue resection system 100a, which is substantially similar to the tissue resection system <NUM> of <FIG>, is shown with the components necessary to illustrate the differences therebetween. The tissue resection system 100a includes first and second fluid outflow tubes 124a', 124b' for separately connecting the endoscope <NUM> and the surgical drape <NUM> to the vacuum pump assembly <NUM>. The first fluid outflow tube 124a' couples the endoscope <NUM> and a first collection container 180a and the second fluid outflow tube 124b' couples the surgical drape <NUM> and a second collection container 180b so that vacuum may be separately drawn through the endoscope <NUM> and the surgical drape <NUM> by the vacuum pump assembly <NUM> of the control console <NUM>. A first vacuum line 171a is coupled to the vacuum pump assembly <NUM> and the first collection container 180a for establishing negative pressure through the first collection container 180a and ultimately through the endoscope <NUM>, and a second vacuum line 171b is coupled to the vacuum pump assembly <NUM> and the second collection container 180b for establishing negative pressure through the second collection container 180b and ultimately through the surgical drape <NUM>.

The vacuum pump assembly <NUM> includes a vacuum line selector 170c that includes a valve 170d for controlling which of the first and second vacuum lines 171a, 171b to draw vacuum through. The vacuum line selector 170c is configured to actuate the valve 170d for drawing vacuum through only the first vacuum line 171a and thus, through the first fluid outflow tube 124a', only the second vacuum line 171b and thus, through the second fluid outflow tube 124b', both of the first and second vacuum lines 171a, 171b, or neither of the first and second vacuum lines 171a, 171b (e.g., in system configurations in which a third vacuum line is associated with a collection container coupled to a fluid and debris outflow tube of a surgical instrument).

In some aspects, the vacuum line selector 170c is coupled to an actuator <NUM> (e.g., a knob) disposed on the control console <NUM> so that a user can manually control the vacuum line selector 170c and choose which, if any, of the first and/or second vacuum lines 171a, 171b to pull vacuum through. For example, the user can choose to open the first vacuum line 171a (e.g., enable suction therethrough) and close the second vacuum line 171b (e.g., prevent suction therethrough) during start-up of the tissue section system 100a so that adequate vacuum pressure can be built up in the tissue resection system 100a for use. The user can then open both the first and second vacuum lines 171a, 171b when the tissue resection system 100a is primed for use, or leave the second vacuum line 171b closed so that exudate passed through the surgical drape <NUM> and the second fluid flow tube 124b' is fed into the second collection container 180b through a gravity feed.

In other aspects, the vacuum line selector 170c is motorized and programmed to automatically open and/or close the first and second vacuum lines 171a, 171b to optimize the vacuum pressure within the tissue resection system 100a. For example, the vacuum line selector 170c may be programmed to initially close the first and second vacuum lines 171a, 171b upon system start-up. As another example, the vacuum line selector 170c may be programmed to open the first vacuum line 171a when an end effector assembly <NUM> (<FIG>) is attached to the handpiece <NUM> of the surgical instrument <NUM> (e.g., via RFID). In certain aspects, the vacuum pump assembly <NUM> may also include sensors 170e, 170f in fluid communication with each of the first and second vacuum lines 171a, 171b to monitor the flow characteristics therethrough, and the vacuum line selector 170c may be programmed to open and close the first and/or second vacuum lines 171a, 171b depending upon the flow characteristics measured by the sensors 170e, 170f (e.g., when flow characteristics are associated with air flow, the vacuum line selector 170c closes the respective first or second vacuum line 171a, 171b, and when the flow characteristics are associated with liquid flow, the vacuum line selector 170c opens the respective first or second vacuum line 171a, 171b).

As shown in <FIG>, a tissue resection system 100b, which is substantially similar to the tissue resection system <NUM> of <FIG> and/or the tissue resection system 100a of <FIG>, is shown with the components necessary to illustrate the differences therebetween. The tissue resection system 100b includes first and second pressure lines 173a, 173b for separately pressurizing the fluid source <NUM> and the collection container <NUM>. The first pressure line 173a couples the pressure pump assembly <NUM> and the fluid source <NUM> so that pressure may be applied to the fluid source <NUM> by the cuff <NUM> of the first pressure line 173a on the fluid source <NUM>. The second pressure line 173b couples the pressure pump assembly <NUM> and the collection container <NUM> so that vacuum may be drawn through the collection container <NUM> by the pressure pump assembly <NUM>.

The pressure pump assembly <NUM> includes a pressure line selector 172a that includes a valve 172b for controlling which of the first and second pressure lines 173a, 173b to utilize. The pressure line selector 172a is motorized and programmed to provide pressure through the first pressure line 173a on the fluid source <NUM> during use of the tissue resection system 100b. The pressure selector 172a is programmed to divert pressure from the first pressure line 173a and through the second pressure line 173b during start-up of the tissue resection system 100b to aid the vacuum pump assembly <NUM> in pressurizing the tissue resection system 100b. The pressure selector 172a be programmed to revert back to providing pressure only through the first pressure line 173a when the tissue resection system 100b is primed for use. In some aspects, the pressure selector 172a may be in communication with the vacuum pump assembly <NUM> such that if a vacuum pressure change is sensed by the vacuum pump assembly <NUM>, the pressure selector 172a is activated to divert pressure through the second pressure line 173b to temporarily increase the vacuum capacity of the tissue resection system 100b by assisting the vacuum pump assembly <NUM> until adequate vacuum pressure is achieved within the tissue resection system 100b.

Claim 1:
A tissue resection system comprising:
a surgical instrument (<NUM>);
a collection container (<NUM>);
a fluid and debris outflow tube (<NUM>) coupled to the surgical instrument and the collection container for withdrawal of fluid and debris through the surgical instrument and into the collection container;
a vacuum pump assembly (<NUM>) including a vacuum pump and a vacuum monitoring assembly (170b); and
a vacuum line (<NUM>) coupled to the vacuum pump assembly and the collection container for providing suction through the fluid and debris outflow tube,
characterised in that the vacuum monitoring assembly (170b) is configured to monitor flow characteristics through the vacuum pump and the surgical instrument includes a valve (<NUM>) disposed within the fluid and debris outflow tube; and further
wherein the valve is movable between a closed position when the vacuum monitoring assembly measures flow characteristics associated with air flow and an open position when the vacuum monitoring assembly measures flow characteristics associated with liquid flow.