System and method for improving control responsiveness during suction

Abstract

An aspiration system for controlling vacuum pressure in an ultrasonic surgical handpiece to improve control responsiveness during aspiration. The system includes a console including a vacuum pump. The system includes a cartridge including a joint that divides a vacuum path into at least two flow paths. The first joint port is coupled to the first flow path. The second flow path is coupled to the second joint port, the third flow path is coupled to the third joint port, and the fourth flow path is coupled to a port on a surgical waste receiver. A first sensor senses the pressure in the fourth flow path and provides a waste receiver pressure signal. A second sensor senses pressure in the third flow path and provides a tip pressure signal. The controller controls positions of the first and second discharge valves based on the waste receiver pressure signal and the tip pressure signal, respectively.

Description

[0001] This application is a divisional application of a Chinese patent application filed on September 24, 2019, with application number 201980074085.9 and named “System and method for improving control responsiveness during suction process”. Background Art

[0002] The present disclosure generally relates to aspiration systems and methods for use with ultrasonic surgical handpieces. Summary of the invention

[0003] One aspect of the present disclosure is to provide a suction system for controlling vacuum pressure in an ultrasonic surgical handpiece. The system includes a vacuum pump and a surgical handpiece connector. The system has a vacuum path that extends at least partially between the surgical handpiece connector and the vacuum pump. The vacuum path includes a first connector, a second connector, and a joint between the surgical handpiece connector and the first connector. The joint divides the vacuum path into at least two pipelines. A first sensor is connected to a first portion of the vacuum path, the first portion of the vacuum path being disposed between the second connector and the vacuum pump. The first sensor is configured to monitor a waste receiver pressure and provide a waste receiver pressure signal. A first exhaust valve is connected to the first portion of the vacuum path. A second exhaust valve is connected to a terminal of a second portion of the vacuum path, the second portion of the vacuum path originating from the joint. A second sensor is connected to the second portion of the vacuum path and is configured to monitor a vacuum pressure associated with a tip of the ultrasonic surgical handpiece and provide a tip pressure signal. A controller is configured to control a position of the first exhaust valve based on the waste receiver pressure signal, and to control a position of the second exhaust valve based on the tip pressure signal.

[0004] A method for controlling the vacuum level of an ultrasonic surgical handpiece is provided. The method includes driving a vacuum pump to generate vacuum pressure within a suction system, including generating suction pressure at a surgical handpiece connector. Surgical waste is deposited into a surgical waste receiver through a connection in a vacuum path. A first sensor senses a first vacuum pressure. The first sensor is positioned along a first portion of the vacuum path, wherein the first portion of the vacuum path extends between a waste receiver connector and a vacuum pump. A first exhaust valve is connected to the first portion of the vacuum path. The method further includes generating a waste receiver pressure signal, sensing a second vacuum pressure using a second sensor positioned along a second portion of the vacuum path extending between the surgical handpiece connector and a second exhaust valve, and generating a tip pressure signal. The method includes controlling a position of the first exhaust valve based on the waste receiver pressure signal and controlling a position of the second exhaust valve based on the tip pressure signal.

[0005] Another aspect of the present disclosure is to provide a suction system for controlling vacuum pressure in an ultrasonic surgical handpiece. The system includes a vacuum pump and a surgical handpiece connector. The system has a vacuum path that extends at least partially between the surgical handpiece connector and the vacuum pump. The vacuum path also includes a first connector and a second connector for a surgical waste receiver. A joint is provided between the surgical handpiece connector and the first connector. The joint divides the vacuum path into at least two flow paths. A first exhaust valve is connected to a first portion of the vacuum path, wherein the first portion of the vacuum path is provided between the waste receiver connector and the vacuum pump. A second exhaust valve is connected to a terminal of a second portion of the vacuum path, wherein the second portion of the vacuum path originates from the joint. A controller is provided to be configured to control the position of the first exhaust valve and the position of the second exhaust valve to maintain a pressure difference so that the pressure in the first portion of the vacuum path is higher than the pressure in the second portion of the vacuum path.

[0006] Another aspect of the present disclosure is to provide a suction system for controlling the vacuum pressure in an ultrasonic surgical handpiece. The system includes a vacuum pump. The vacuum path extends at least partially between the ultrasonic surgical handpiece and the vacuum pump. The vacuum path further includes a first connector, a second connector, and a joint between the surgical handpiece connector port and the second connector, the surgical handpiece connector port being configured to be placed in fluid communication with the ultrasonic surgical handpiece. The joint divides the vacuum path into at least two pipelines. The first exhaust valve is connected to a first portion of the vacuum path, wherein the first portion is disposed between the first connector and the vacuum pump. The second exhaust valve is connected to a terminal of a second portion of the vacuum path, wherein the second portion originates from the joint and extends along the vacuum path to the second exhaust valve. The system also includes a first sensor, a second sensor, and a controller, the controller being configured to determine a first flow rate based on a first input signal received from the first sensor, and to determine a second flow rate based on a second input signal received from the second sensor. The controller is also configured to output a tip occlusion signal based on the first flow rate and the second flow rate, and to control the vacuum pump based on the tip occlusion signal.

[0007] Another method for controlling vacuum pressure in an ultrasonic surgical handpiece is provided. The method includes driving a vacuum pump to generate vacuum pressure within a suction system. A first sensor is connected to a first portion of a vacuum path, wherein the first portion is disposed between a first connector and a vacuum pump. A first exhaust valve is connected to the first portion of the vacuum path. The first sensor senses a first vacuum pressure. A second sensor is connected to a second portion of the vacuum path, wherein the second portion originates from a joint. The joint divides the vacuum path into at least two lines and extends along the vacuum path to a second exhaust valve. The second sensor senses a second vacuum pressure. The method also includes generating a first input signal received from the first sensor and a second input signal received from the second sensor. Based on the first input signal and the second input signal, the method includes determining a first flow rate and a second flow rate, respectively. Then, based on the first flow rate and the second flow rate, the method includes outputting a tip blockage signal and controlling the vacuum pump based on the tip blockage signal.

[0008] Another aspect of the present disclosure is to provide a suction system, which includes an ultrasonic surgical handpiece, a vacuum pump, and a vacuum path extending at least partially between the ultrasonic surgical handpiece and the vacuum pump. A first connector, a second connector, and a joint between the surgical handpiece connector port and the first connector are provided. The joint divides the vacuum path into at least two pipelines. A first exhaust valve is connected to a first portion of the vacuum path. The first portion is disposed between the first connector and the vacuum pump. The second exhaust valve is connected to a terminal of the second portion of the vacuum path, wherein the second portion originates from the joint and extends along the vacuum path to the second exhaust valve. A first sensor and a second sensor are also provided, the first sensor being connected to the first portion of the vacuum path, and the second sensor being connected to the second portion of the vacuum path. The system also includes a controller configured to: determine a first flow rate based on a first input signal received from the first sensor; determine a second flow rate based on a second input signal received from the second sensor; output a tip occlusion signal based on the first flow rate and the second flow rate, and control the vacuum pump based on the tip occlusion signal.

[0009] Another aspect of the present disclosure is to provide an aspiration system for controlling vacuum pressure in an ultrasonic surgical handpiece to obtain improved control responsiveness during aspiration. The aspiration system includes: a console including a vacuum pump; a surgical waste receiver having a first surgical waste receiver port and a second surgical waste receiver port; and a connector defining a first connector port, a second connector port, and a third connector port. The first connector port is connected to a first flow path extending from the ultrasonic surgical handpiece. The second flow path is connected to the second connector port and the first surgical waste receiver port. The third flow path is connected to the third connector port. The fourth flow path is connected to the second surgical waste receiver port. The first sensor is positioned to sense pressure in the fourth flow path and is configured to monitor the waste receiver pressure and provide a waste receiver pressure signal. The second sensor is positioned to sense pressure in the third flow path and is configured to monitor the vacuum pressure associated with the tip of the ultrasonic surgical handpiece and provide a tip pressure signal. The first exhaust port is connected to the fourth flow path. The second exhaust port is connected to the third flow path. The system also includes a controller configured to control a position of the first drain valve based on the waste receptacle pressure signal and to control a position of the second drain valve based on the tip pressure signal.A vacuum pump is coupled to the fourth flow path.

[0010] Another method of controlling a suction system to obtain improved control responsiveness during operation is provided. The suction system includes a vacuum pump, an ultrasonic surgical handpiece, a surgical waste receiver, a clean side flow path, and a dirty side flow path. The system also includes a fluid return device in communication with the clean side flow path and a clean side exhaust mechanism in communication with the dirty side flow path. The clean side flow path is disposed between the vacuum pump and the surgical waste receiver, and the dirty side flow path is disposed between the ultrasonic surgical handpiece and the fluid return device. The method includes sensing a first pressure within the dirty side flow path; sensing a second pressure within the clean side flow path; controlling the fluid return device based on the first pressure; and controlling the clean side exhaust mechanism based on the second pressure.

[0011] Another aspect of the present disclosure is to provide an aspiration system for controlling vacuum pressure in an ultrasonic surgical handpiece to obtain improved control responsiveness during aspiration. The system includes: a console including a vacuum pump; an ultrasonic surgical handpiece; a surgical waste receiver; a clean side flow path and a dirty side flow path. The clean side flow path is disposed between the vacuum pump and the surgical waste receiver. A fluid return device is provided, which is in communication with the clean side flow path, and a clean side exhaust mechanism is in communication with the dirty side flow path. The dirty side flow path is disposed between the ultrasonic surgical handpiece and the fluid return device.

[0012] Another aspect of the present disclosure is to provide an aspiration system for controlling vacuum pressure in an ultrasonic surgical handpiece to obtain improved control responsiveness during aspiration. The system includes a console for being fluidly coupled to the ultrasonic surgical handpiece, wherein the console includes a controller, a vacuum pump, a first sensor, a fluid return device, a second sensor, and a clean side exhaust mechanism. The controller is configured to control the clean side exhaust mechanism based on an input signal from the first sensor, and to control the fluid return device based on an input signal from the second sensor.

[0013] Another aspect of the present disclosure is to provide an aspiration system for controlling vacuum pressure in an ultrasonic surgical handpiece to obtain improved responsiveness during aspiration. The system includes a console for being fluidly coupled to the ultrasonic surgical handpiece, wherein the console includes a controller, a vacuum pump, a first exhaust mechanism, and a second exhaust mechanism, the system being configured to be placed in communication with a surgical waste receiver. The controller is configured to control the first exhaust mechanism in response to aspiration of liquid and solid matter through the surgical handpiece, and the controller is configured to control the second exhaust mechanism to maintain a desired pressure in the surgical waste receiver. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Referring now to the drawings, exemplary illustrations are shown in detail. Although the drawings represent illustrative embodiments, the drawings are not necessarily drawn to scale and certain features may be exaggerated to better illustrate and explain the innovative aspects of the illustrative embodiments. In addition, the exemplary illustrations described herein are not intended to be exhaustive or otherwise limited or restricted to the precise forms and configurations shown in the drawings and disclosed in the following detailed description.

[0015] Advantages of the present disclosure will be readily appreciated as the disclosure becomes better understood by reference to the following detailed description when considered in conjunction with the accompanying drawings, wherein:

[0016] Figure 1 Certain components of the aspiration system are depicted, including the ultrasonic surgical handpiece and console.

[0017] Figure 2 is a schematic diagram of components of an aspiration system for removing irrigation fluid and surgical waste from a surgical site according to one example.

[0018] Figure 3 Certain components of an aspiration system according to one example are depicted, wherein a distinction is made between a clean side and a dirty side of a flow path.

[0019] Figure 4 is an exploded view of a cassette including tubing for the aspiration and irrigation system.

[0020] Figure 5A is a view of an assembled cassette according to one example.

[0021] Figure 5B is a view of an assembly cassette inserted into a console according to one example.

[0022] Figure 6 Depicted is a cross section of a pinch valve in a console aligned with a portion of the vacuum path and cassette of the system.

[0023] Fig. 7A is a perspective view of certain internal components of the aspiration system within the console, including the pinch valve.

[0024] Figure 7B is another perspective view of the internal components of the aspiration system within the console, including the controller and the aspiration manifold.

[0025] Figure 7C is an enlarged view of the suction manifold of the suction system within the console.

[0026] Figure 8 is a top view of the suction manifold showing the pressure sensor and its connection to the vacuum path.

[0027] Fig. 9 is a circuit diagram for an exemplary pressure sensor.

[0028] Fig.10 is a block diagram of a control system, the control system includes a first PID control loop and a second PID control loop, the control system is used to adjust the Figure 1 The first discharge valve and the second discharge valve of the suction system.

[0029] Fig.11 is a graphical representation of the target and actual pressures at different points in the vacuum path based on different suction set points.

[0030] Fig.12 Depicted is a schematic diagram of a suction system using electrical schematic connections to represent aerodynamic resistance according to one example.

[0031] Fig.13 Depicted is an operational routine implemented by an aspiration system to determine whether an obstruction is detected within an ultrasonic surgical handpiece, according to one example. DETAILED DESCRIPTION

[0032] I. System Overview

[0033] Figure 1Certain components of the suction system 42 are depicted. The suction system 42 is described for use with the ultrasonic surgical hand piece 28 and the console 20, but in certain configurations can be used with other hand pieces that are actuated mechanically, such as power drills, drill bits, and saws. The ultrasonic surgical hand piece 28 includes an ultrasonic surgical hand piece tip 30 through which the surgical site is suctioned. It will be understood that suction includes any form of matter from the surgical site. For example, the ultrasonic surgical hand piece 28 can suction liquids and solid matter from the surgical site through the ultrasonic surgical hand piece. It will also be understood that, unless otherwise specified, "proximal" is understood to mean toward the surgical hand piece tip 30, while "distal" is understood to mean away from the surgical hand piece tip 30.

[0034] The suction system 42 includes a console 20 that provides power and suction to the ultrasonic surgical hand piece 28. The console 20 includes a display 22 to display the amount of power, irrigation, suction, or a combination thereof. The console 20 may also be connected to a foot pedal 32, a manual switch, or any other control device that controls whether the surgical hand piece tip 30 is actively vibrating when the ultrasonic surgical hand piece 28 is turned on.

[0035] According to one configuration, the aspiration system 42 includes a console 20, a cassette 34, and an ultrasonic surgical handpiece 28, the console 20 including a vacuum pump 74. In another configuration, the aspiration system 42 includes a surgical console 20, a vacuum pump 74, a surgical waste receptacle 70 or other waste container, a cassette 34, and an ultrasonic surgical handpiece 28.

[0036] Figure 2 is a schematic diagram of components of the suction system 42 for removing irrigation fluid and surgical waste from a surgical site. The console 20, surgical waste receiver 70, cassette 34, and / or ultrasonic surgical handpiece 28 may include any number of ports / connectors so that the components can be fluidly coupled together. For example, the ultrasonic surgical handpiece 28 may include an ultrasonic surgical handpiece connector 26. The components of the suction system 42 are coupled together with a variety of pipes or lines to form a vacuum path 40. A vacuum pump 74 generates a vacuum pressure throughout the vacuum path 40 that causes most of the surgical waste and irrigation fluid (which may be in the form of a liquid, gas, solid, or a combination thereof) to move through the vacuum path 40 and ultimately reach the surgical waste receiver 70.

[0037] The cassette 34 may include a portion of the tubing including the vacuum path 40. When the cassette 34 is inserted into the console 20, the cassette 34 and the console 20 are aligned with the first port 95, the second port 96, and the third port 98 of the suction manifold 36 within the console 20 so that the tubing of the vacuum path 40 extends from the ultrasonic surgical handpiece 28, the pinch valve 62, and the filter 72 to the corresponding ports, such as Figure 2 The surgical handpiece tip 30 is coupled to a waste line 38, and the waste line 38 extends from the surgical handpiece tip 30 to a connector 44 in the cassette 34. Figure 2 As shown in , the connector 44 divides the vacuum path 40 into at least two flow paths. It will be understood that unless otherwise specifically stated, the pipeline can be described as a pipe and / or a flow path. The connector 44 can include a fluid return device 462 that allows air to pass through, but prevents surgical waste or aspirated fluid from entering multiple portions of the vacuum path 40 beyond the fluid return device 462.

[0038] In one configuration, the connector 44 includes a first connector port 440, a second connector port 442, and a third port connector 444. The surgical waste receiver 70 includes a first surgical waste receiver port 446 and a second surgical waste receiver port 448. The first surgical waste receiver connector 82 is connected to the first surgical waste receiver port 446, and the second surgical waste receiver connector 66 is connected to the second surgical waste receiver port 448.

[0039] The flow path of the vacuum path 40 can be described with respect to the connector 44, the surgical waste receptacle 70, and the vacuum pump 74. The first connector port 440 is coupled to a first flow path 450 extending from the ultrasonic surgical hand piece 28. The second flow path 452 is coupled to the second connector port 442 and the first surgical waste receptacle port 446. The third flow path 454 is coupled to the third connector port 444, and the fourth flow path 456 is coupled to the second surgical waste receptacle port 448. The fourth flow path 456 extends at least partially from the second surgical waste receptacle port 448 to the vacuum pump 74.

[0040] Alternatively described, the vacuum path 40 can be divided into three portions. A first portion 40a of the vacuum path 40 is positioned between the second surgical waste receiver connector 66 and the vacuum pump 74. A second portion 40b of the vacuum path 40 originates from the connector 44 and extends along the vacuum path 40 to the second exhaust valve 60. The second exhaust valve 60 can be used to exhaust the vacuum path 40 to the atmosphere, as will be further described below. A third portion 40c of the vacuum path 40 extends at least partially from the connector 44 to the first surgical waste receiver connector 82.

[0041] It will be understood that the first flow path 450 is associated with the waste line 38; the second flow path 452 is associated with the third portion 40c of the vacuum path 40; the third flow path 454 is associated with the second portion 40b of the vacuum path 40; and the fourth flow path 456 is associated with the first portion 40a of the vacuum path 40, unless otherwise specifically stated.

[0042] Additionally or alternatively, the vacuum path 40 can be divided into two flow paths: a clean side flow path 458 and a dirty side flow path 460. The clean side flow path 458 is positioned between the vacuum pump 74 and the surgical waste receptacle 70. The dirty side flow path 460 is positioned between the ultrasonic surgical hand piece 28 and a fluid reflux device 462. The fluid reflux device 462 can be configured to communicate with the dirty side flow path 460, and a clean side drain mechanism 464 can be configured to communicate with the clean side flow path 458. It will be understood that the clean side drain mechanism 464 can be a first drain mechanism including a first drain valve 54. In some configurations, the system 42 includes a second drain mechanism 461 having a second drain port 60. The fluid reflux device 462 can be implemented to help lose vacuum pressure by introducing fresh air into the dirty flow path 460. Referring to Figure 3 The "clean side" is free of any surgical waste (e.g., tissue and fluid), and the "dirty side" includes surgical waste aspirated from the surgical site. The "clean side" is between the vacuum pump 74 ( Figure 3 The "dirty side" is between the ultrasonic surgical handpiece 28 and the fluid return device 462 (not shown) and the surgical waste receiver 70. Figure 3 In other words, in this configuration, the surgical waste receptacle 70 can provide a functional boundary between the clean side and the dirty side of the flow path.

[0043] To allow direct discharge to the third portion 40c and / or the dirty side flow path 460 through the second drain 461, a combination of the directionality of the fluid return 462, gravity, and suction / aspiration (which tends to keep surgical waste flowing away from the fluid return 462), the dirty side flow path 460 can be used. These design features ensure that surgical waste does not contaminate the second drain 461.

[0044] By providing multiple lines, paths and / or multiple portions of the vacuum path 40, the advantage of the system 42 is that the pressure is double-regulated by the first sensor 48 and the second sensor 57. In addition, another advantage of the system 42 is the improved control responsiveness during the operation of performing blockage detection. The first sensor 48 is positioned to sense the pressure in the first portion 40a of the vacuum path 40 and monitor the waste receiver pressure. The second sensor 57 is positioned to sense the pressure in the second portion 40b of the vacuum path 40 and monitor the vacuum pressure associated with the ultrasonic surgical handpiece tip 30. The system 42 includes a controller 102 for controlling the first exhaust valve 54 and the second exhaust valve 60 based on signals from the first sensor 48 and the second sensor 57. In addition or alternatively, the clean side exhaust mechanism 464 may include the first exhaust valve 54. The fluid return device 462 may be a joint 44, which includes a joint valve or a ball valve 86. The first exhaust valve 54 and the second exhaust valve 60 may be opened to introduce atmospheric air or fresh air into the system 42 to lose vacuum pressure. The dual regulation and blockage detection performed by the first sensor 48 and the second sensor 57 will be discussed in more detail below.

[0045] Using dual regulation, the system 42 regulates the pressure in the surgical waste receiver 70 and the pressure at the surgical site. The system 42 results in improved control responsiveness during various operations of the ultrasonic surgical handpiece 28, an overall wider suction control range, finer adjustment of the suction setting value, and more optimized suction performance. For example, using dual regulation (e.g., using a first exhaust mechanism and a second exhaust mechanism), significantly lower suction levels can be achieved, which significantly reduces tissue "pull" forces, which is very important for avoiding the formation of fragile structures, thereby providing a comfortable environment for patients and operators.

[0046] Once liquid and solid matter are sucked from the surgical site into the waste line 38 using the ultrasonic surgical handpiece 28, the surgical waste flows through the connector 44 and the pinch valve 62. In this configuration, the vacuum path 40 leads to the surgical waste receiver 70, and gravity removes surgical waste from the second portion 40b of the vacuum path 40. The second surgical waste receiver connector port 448 is connected to the second surgical waste receiver connector 66, which is connected to the filter 72. From the perspective of the console, the filter 72 is located proximally compared to the surgical waste receiver 70. The filter 72 is designed to remove the remnants of surgical waste that are not captured by the surgical waste receiver 70 from the second portion 40b of the vacuum path 40. The filter 72 can be a part of the cassette assembly and / or the pipeline so that the filter 72 can be easily disposed and replaced after the operation. The filter 72 is connected to the console 20 via another pipeline through the first port 95.

[0047] Figure 4 An exploded view of the cassette 34 is depicted. In one configuration, the cassette may be optional. In other words, although the cassette 34 itself may be omitted, the tubing and connector 44 that couple the ultrasonic surgical handpiece 28 to the surgical waste receptacle 70 will still be included. Figure 4 As shown in FIG. 4 , the connector 44 includes a ball valve 86 or any other type of fluid return device 462 .

[0048] The ball valve 86 / fluid return device 462 is a one-way valve that allows air to pass from the second portion 40b of the vacuum path 40 to the third portion 40c of the vacuum path 40, but prevents surgical waste or aspirated fluid from entering the second portion 40b of the vacuum path 40 from the surgical handpiece tip 30. The ball valve 86 is installed so that the ball of the ball valve 86 is biased to an open position under the action of gravity and may be pushed upward to a closed position by the impact of liquid from the third portion 40c of the vacuum path 40. A chamber 88 is also included, which is located near the ball valve 86 and distal to it to retain any surgical waste that does pass through the ball valve 86 into the second portion 40b of the vacuum path 40. The chamber 88 may have an inclined floor. Once the ball of the ball valve 86 returns to its resting position, the inclined floor of the chamber 88 causes the surgical waste that does pass through the ball valve 86 to flow back into the third portion 40c of the vacuum path 40. Other types of valves may be used instead of the ball valve to control the flow of fluid in the second portion 40 b of the vacuum path 40 .

[0049] like Figure 4-5B As shown in , the cassette 34 can be used to more easily arrange the irrigation lines and aspiration lines relative to the console 20. In this configuration, the irrigation lines 90 and 92 and the vacuum path 40 lines are all included in a single cassette 34. In some configurations, any irrigation line 90 / 92 can be set to connect the ultrasonic surgical handpiece 28 to the irrigation source 91. In some configurations, the irrigation fluid can be sent to the ultrasonic surgical handpiece connector 26 through the cassette 34. The setup and operation of the ultrasonic aspirator is simplified by including irrigation and aspiration in the same cassette 34. Presetting the tubing in the cassette 34 also avoids user errors, which may, for example, cause the misalignment of the pinch valve 62 relative to the vacuum path 40.

[0050] Figure 5A and Figure 5B is a view of the cartridge 34. The user inserts the cartridge 34 into the console 20 in a single motion requiring one hand. By completing this single action, the console 20 detects the cartridge RFID (radio frequency identification) tag 94, indicating that the cartridge 34 has been fully inserted. Once the cartridge 34 is inserted and aligned, the pinch valve 62 can be activated by the user. The pinch valve 62, when actuated, compresses the tubing of the third portion 40c of the vacuum path 40 held in the cartridge 34.

[0051] like Figure 7A-7B As shown in FIG. 1 , a cartridge release button 500 is provided on the console 20. The cartridge container 76 may include one or more sensors, such as a Hall effect sensor, a magnetic sensor, or other suitable sensors, which generate a signal in response to pressing the cartridge release button 500. In this configuration, as shown in FIG. Figure 7B As shown in , the cartridge release button 500 includes a magnet 93, and the cartridge container 76 includes a printed circuit board assembly (PCBA) 99 with a Hall effect sensor 89. The magnet 93 helps detect whether the cartridge 34 is inserted and / or is about to be ejected. As the cartridge release button 500 is pressed, the magnet 93 helps detect when the cartridge 34 is about to be ejected as the magnet 93 gets closer to the Hall effect sensor 89. In response, before ejecting the cartridge 34, the system 42, the controller 102, and / or the PCBA 99 releases the pinch valve 62. This ensures that the cartridge 34 is ejected correctly.

[0052] The cassette housing 84 includes an opening 85 above the conduit, such as Figure 5B As shown in FIG. 4 , the conduit defines a third portion 40 c of the vacuum path 40 that is aligned with the pinch valve 62. When the cartridge 34 is inserted into the console 20, as shown in FIG. Figure 5B As shown in FIG. 8 , the opening 85 of the cassette housing 84 is positioned adjacent to the pinch valve 62. Figure 6 , if the pinch valve is actuated, the rod 172 is used to pinch the third portion 40c of the vacuum path 40. The pinch valve 62 prevents the vacuum pressure from reaching the ultrasonic surgical hand piece tip 30. More specifically, the pinch valve 62 affects the degree of blockage in the vacuum path 40 by ensuring a responsive cutoff of the vacuum pressure at the ultrasonic surgical hand piece tip 30.

[0053] In addition, the console 20 may further include a three-way solenoid valve 64, such as Fig. 7A . The three-way solenoid valve 64 controls actuation of the pinch valve 62. The three-way solenoid valve 64 is connected to the vacuum pump 74 via the first portion 40a of the vacuum path 40. When the suction system 42 is operated to remove surgical waste at the surgical handpiece tip 30, the pinch valve 62 is connected to the atmosphere via the three-way solenoid valve 64. In this configuration, the pinch valve 62 is pneumatically actuated and is opened and closed by moving the three-way solenoid valve 64 to allow vacuum pressure to engage the mechanical actuator 100 of the pinch valve 62, which includes a coil 170, a rod 172, a gasket 174, and a pump head 110, as shown in FIG. Figure 6 In other configurations, the pinch valve 62 is electrically actuated and the three-way solenoid valve 64 is not required.

[0054] In connection with the pinch valve 62 and the three-way solenoid valve 64, the suction system 42 can operate in one or more modes, including a standard mode and a synchronized mode. In the standard mode, the pinch valve 62 and the three-way solenoid valve 64 operate in the same manner regardless of whether the foot pedal 32 is depressed to operate the surgical handpiece 28. Whenever the power to the console 20 is turned on, suction is provided at the ultrasonic surgical handpiece tip 30 in the standard mode. In the standard mode, the pinch valve 62 is continuously in a static state, wherein the pinch valve 62 connects the surgical handpiece tip 30 to the surgical waste receiver 70 and the vacuum pump 74 in an open manner via the vacuum path 40.

[0055] Specifically, in the standard mode, the three-way solenoid valve 64 is always open to atmosphere and closed relative to the vacuum path 40. This allows the vacuum to reach the surgical handpiece tip 30 and provide suction at the surgical site. For a suction system designed to be always open, the system 42 can be made without the three-way solenoid valve 64 or the pinch valve 62.

[0056] The second potential operating mode of suction is the synchronous mode. In the synchronous mode, when the foot pedal 32 is not depressed to vibrate the surgical handpiece tip 30, suction is not allowed to reach the surgical site. Specifically, the pinch valve 62 is active, thereby cutting off the connection between the surgical handpiece tip 30 and the vacuum pump 74 when the foot pedal 32 is not depressed and the ultrasonic surgical handpiece tip 30 is not vibrating. The pinch valve 62 is actuated by the three-way solenoid valve 64. The solenoid of the three-way solenoid valve 64 moves so that when the foot pedal 32 is not depressed, the pinch valve 62 is closed relative to the atmosphere and opened to the vacuum path 40. This prevents the vacuum from reaching the surgical handpiece tip 30 and the surgical site. When the foot pedal 32 is not depressed, the second exhaust valve 60 is also open to the atmosphere to quickly dissipate any vacuum pressure at the surgical site.

[0057] In the synchronized mode, when the foot pedal 32 is depressed to operate the ultrasonic surgical hand piece 28, the suction system 42 functions the same as described for the standard mode. For example, the pinch valve 62 is in a static state so that when the foot pedal 32 is depressed, the vacuum path 40 is unobstructed between the ultrasonic surgical hand piece tip 30 and the vacuum pump 74.

[0058] The vacuum pump 74 is selectively connected to the pinch valve 62 through the three-way solenoid valve 64. The pinch valve 62 is connected to a container 76 for the cassette 34, such as Figure 7A-7BAs shown in . In this configuration, the vacuum pump 74 adopts a double diaphragm design, which keeps the elements of the vacuum pump 74 separated from the pumped air. In addition, the two diaphragms provide twice the airflow for each stroke of the piston as a single diaphragm, allowing the vacuum pump 74 to operate at a low speed. In addition, in this configuration, the pump head 110 can be plastic to reduce mechanical pumping noise. As shown in Figure 5, the pump head 110 is in-line to shorten the length of the vacuum path 40. Shortening the length of the tube near the vacuum pump 74 limits the possibility of tube vibration and unwelcome noise.

[0059] Figure 7B A view of the suction manifold 36 including the first drain valve 54 , the second drain valve 60 , and the controller 102 is provided. Figure 7B Also shown is a cartridge receptacle 76 into which the user inserts the cartridge 34. Figure 7B , the container 76 of the cassette 34 includes an opening to the pinch valve 62. Once the cassette 34 is properly inserted, the opening 85 in the cassette housing 84 aligns with the opening in the container 76, allowing the pinch valve 62 to engage the line of the vacuum path 40.

[0060] Figure 7C and Figure 8 An alternative close-up view of the suction manifold 36 is provided. The suction manifold 36 includes a first sensor 48, a second sensor 57, a first drain valve 54, a second drain valve 60, and a printed circuit board 102. In this configuration, the first sensor 48, including the differential pressure sensor 50a and the gauge pressure sensor 52a, can be used to determine a first vacuum pressure 180 in the surgical waste receptacle 70 and generate a measured waste receptacle pressure signal 132 based on the first vacuum pressure 180. Similarly, the second sensor 57, including the differential pressure sensor 50b and the gauge pressure sensor 52b, can be used to determine a second vacuum pressure 182 at the surgical site and generate a measured tip pressure signal 133. Both signals are provided to the controller 102, which in this configuration is the printed circuit board 102, to control the first drain valve 54 and the second drain valve 60.

[0061] The suction manifold 36 helps distribute the air flow from the vacuum pump 74 to the vacuum path 40 and the pinch valve 62. Differential pressure sensors 50a, 50b may be used to monitor the pressure or flow in the first portion 40a and the second portion 40b of the vacuum path 40. Additionally or alternatively, gauge pressure sensors 52a, 52b may be used to monitor the pressure in the first portion 40a and the second portion 40b. Figures 7A-7C The machined manifold 104 shown in FIG. 1 distributes vacuum flow among the first and second portions 40a, 40b of the vacuum path 40 by operating the exhaust ports to atmosphere through the first and second exhaust valves 54, 60, as well as any other valves and mufflers.

[0062] Figures 7A-7C The main muffler 106 shown in Figure 1 mitigates the pumping exhaust noise from the vacuum pump 74. Pulsating exhaust air is one of the largest noise contributors in the system 42. In this configuration, the mechanical actuator 100 has a large cross-sectional flow path to allow the vacuum in the pinch valve 62 to be quickly vented to the atmosphere. This allows the pinch valve 62 to quickly return to its open position.

[0063] Fig. 9 is a circuit diagram for an exemplary pressure sensor. In this example, a 15 PSI sensor is connected to the vacuum path 40. Measurements of the vacuum path 40 can be made using differential pressure sensors 50a, 50b and gauge pressure sensors 52a, 52b. The first sensor 48 and the second sensor 57 output a voltage representing the pressure. The voltage signal is sent to the amplifier 120, which is a differential operational amplifier with adjustable gain in this configuration. The sensed signal is then passed through a low pass filter 122 to reduce noise from the signal. In this configuration, the low pass filter 122 includes a capacitor 123 and a resistor 124. Finally, the signal is processed by a rectifier 125 to generate a modified signal. The modified signal is further processed in the controller 102. The processing of the sensed signal is depicted as using specific hardware, but can also be implemented using general hardware and software.

[0064] II. Double adjustment

[0065] To improve control responsiveness during suction, the console 20 or more specifically, the suction manifold 36 includes a first exhaust valve 54, a first sensor 48, a second exhaust valve 60, and a second sensor 57. As described above, the first exhaust valve 54 can be associated with a clean side exhaust mechanism. The first exhaust valve 54 is positioned along the first portion 40a of the vacuum path, and the second exhaust valve 60 is positioned at the terminal 47 of the second portion 40b of the vacuum path 40 to adjust the suction system 42, or positioned at a proximal position of the fluid return device 462.

[0066] The console 20 may include a controller 102. The first sensor 48 and the second sensor 57 are coupled to the controller 102 to provide dual regulation of the system 42. The controller 102 is configured to control the first discharge valve 54 and the second discharge valve 60 to regulate the vacuum level in the suction system 42. More specifically, the controller 102 is configured to individually control the position of the first discharge valve 54 and the position of the second discharge valve 60 based on the outputs of the first sensor 48 and the second sensor 57, respectively.

[0067] Adjustment of both the first exhaust valve 54 and the second exhaust valve 60 helps maintain the desired vacuum pressure at the surgical site. In this configuration, the first exhaust valve 54 and the second exhaust valve 60 are variable flow iDP (intelligent diagnostic positioner) valves. The air flow through the first exhaust valve 54 and the second exhaust valve 60 is proportional to the current, which is controlled by the first PID (proportional integral derivative) control loop 126 and the second PID control loop 128 in the controller 102. The first PID control loop 126 and the second PID control loop 128 are further described below.

[0068] First sensor 48 is positioned along first portion 40a of vacuum path 40 to effectively sense pressure in surgical waste receptacle 70. Additionally, second sensor 57 and second exhaust valve 60 are included along second portion 40b of vacuum path 40 to provide faster, more responsive control.

[0069] In this configuration, the first sensor 48 may include a differential pressure sensor 50a and / or a gauge pressure sensor 52a. In alternative configurations, different types of pressure sensors may be used. The reading from the first sensor 48 is used to generate a first input signal 232 that is sent to the controller 102 to control the first discharge valve 54 to selectively open the first portion 40a of the vacuum path 40 to the atmosphere. The first input signal may be based on the first vacuum pressure 180. Additionally or alternatively, the first input signal 232 may be a measured waste receiver pressure signal 132. In other configurations, the first input signal 232 may be based on the maximum first discharge current 156 or the first discharge current 164.

[0070] Based on the signal provided by the first sensor 48, the first exhaust valve 54 can be positioned to exhaust the vacuum path 40 to atmosphere. Although the response speed is slower than the reduction in vacuum pressure at the tip 30 of the ultrasonic surgical hand piece 28 caused by the opening of the second exhaust valve 60, this reduces the vacuum pressure in the first portion 40a of the vacuum path 40 and ultimately reduces the vacuum pressure in the entire vacuum path 40. The first exhaust valve 54 can be a variable valve that can be actuated mechanically, electrically, or pneumatically.

[0071] The combination of the first sensor 48 and the first drain valve 54 positioned along the first portion 40a of the vacuum path 40 helps control the vacuum pressure at the surgical site. However, due to the large volume of the surgical waste receptacle 70, the first portion 40a of the vacuum path 40, and the third portion 40c of the vacuum path 40, the control provided by the first drain valve 54 may be slow to respond to pressure changes in the system 42. The compliance of the first portion 40a of the vacuum path 40 and the third portion 40c of the vacuum path 40 (the expansion and contraction of the first portion 40a of the vacuum path 40 and the third portion 40c of the vacuum path 40) may exacerbate this problem. This is because the tubing defining the portions 40a, 40b, and 40c of the vacuum path 40 may expand, resulting in an even larger volume as the pressure in the system 42 changes.

[0072] To improve control responsiveness, a second sensor 57 and a second exhaust valve 60 are included along the second portion 40b of the vacuum path 40. Similar to the first sensor 48, the second sensor 57 may include a differential pressure sensor 50b and / or a gauge pressure sensor 52b. It will be understood that the first sensor 48 and the second sensor 57 may be any type of sensor, including but not limited to a pressure sensor, a temperature sensor, an ultrasonic sensor, and a gas sensor. It will also be further understood that the first sensor 48 and the second sensor 57 may include any number of discrete sensors.

[0073] The second sensor 57 is configured to effectively sense the second vacuum pressure 182 at the surgical handpiece tip 30. The reading from the second sensor 57 is used to generate a second input signal 233, which is sent to the controller 102 to control the second exhaust valve 60 to selectively open the second portion 40b of the vacuum passage 40 to the atmosphere.

[0074] The second exhaust valve 60 is operable to exhaust the vacuum path 40 to atmosphere, thereby reducing the pressure in the vacuum path 40 or near the location of the fluid return device 462. More specifically, the second exhaust valve 60 is placed at the terminal end 47 of the second portion 40b of the vacuum path 40. In this configuration, the second exhaust valve 60 is also located distally compared to the second sensor 57. The second exhaust valve 60 can be the same as or different from the first exhaust valve 54.

[0075] In one configuration or during certain modes, the vacuum pressure at the ultrasonic surgical hand piece 28 is completely controlled by the second exhaust valve 60. In this configuration, the system 42 has a lower pressure at the tip 30 of the ultrasonic surgical hand piece 28, which provides a sense of a lower suction set point, and the suction line between the cassette 34 and the surgical waste receptacle 70 is cleared at a faster rate, thereby reducing blockages. By using the second sensor 57, the system 42 is able to monitor the pressure at the tip 30 of the surgical hand piece 28, which allows the system 42 to detect possible blockages in the suction line. The reading from the second sensor 57 can be a representation of the pressure at the tip 30, which can be used to estimate the flow at the tip 30 of the surgical hand piece 28. Once the flow is estimated, the system 42 can detect possible blockages. Allowing the system 42 to detect potential blockages in the system 42 helps maintain ideal conditions during operation and optimize the required ultrasonic energy.

[0076] The second vacuum pressure 182 is less affected by the large volume of the surgical waste receptacle 70, and therefore, even if the second sensor 57 is also positioned in the console 20, the reading from the second sensor 57 is more representative of the actual pressure at the tip 30 of the ultrasonic surgical hand piece 28. The control of the second exhaust valve 60 provides a faster response to control the pressure at the surgical hand piece tip 30 than the control of the first exhaust valve 54. The faster control is obtained because there is a much smaller volume between the surgical hand piece tip 30 and the second exhaust valve 60 than between the surgical waste receptacle 70 and the first portion 40a of the vacuum path 40 where the first exhaust valve 54 is located. This is also largely because the second exhaust valve 60 is closer to the tip 30 of the ultrasonic surgical hand piece 28 than the surgical waste receptacle 70, which contains a large volume. In addition, because the second portion 40b of the vacuum path 40 contains a much smaller volume than the first portion 40a of the vacuum path 40, the second portion 40b of the vacuum path 40 is less compliant and less likely to be deformed by vacuum pressure.

[0077] The vacuum control algorithm uses signals representing the pressure at the tip 30 and surgical waste receptacle 70 to dynamically adjust the suction force by varying the current supplied to the first and second exhaust valves 54 , 69 , and thereby vary the pressure and flow in the system 42 .

[0078] Fig.101 is a block diagram of a portion of the controller 102, which shows a control system 42 for controlling vacuum pressure in the ultrasonic surgical hand piece 28 to result in improved control responsiveness during operation of the ultrasonic surgical hand piece 28. A first PID control loop 126 and a second PID control loop 128 are used to regulate the pressure in the vacuum path 40. A first PID controller 152 and a second PID controller 154 use a plurality of inputs to output a first exhaust current 164 and a second exhaust current 166, respectively, to adjust the positions of the first exhaust valve 54 and the second exhaust valve 60, respectively.

[0079] Signals from the first sensor 48 and the second sensor 57 provide a first input signal 232 and a second input signal 233. In one configuration, the first input signal 232 is a measured waste receptacle pressure signal 132 and the second input signal 233 is a measured tip pressure signal 133. Other inputs may include a maximum waste receptacle pressure signal 138, a minimum handpiece pressure signal 136, a tip occlusion signal, an aspiration set point 140, a foot pedal set point 142 - all of which are described in more detail below.

[0080] By reading data from the first sensor 48 and the second sensor 57 and interfacing with the first drain valve 54 and the second drain valve 60, the first PID control loop 126 and the second PID control loop 128 actively change the current delivery to the first drain valve 54 and the second drain valve 60 and improve the system response. In addition, in certain configurations where the first sensor and the second sensor are flow meters, the readings from the first sensor 48 and the second sensor 57 allow the controller 102 to monitor the flow of the entire system 42 and detect possible blockages in the suction line. Detection of blockages in the system 42 will be discussed in more detail below.

[0081] The first PID control loop 126 receives input regarding the pressure in the first portion 40a of the vacuum path 40 and is therefore responsible for regulating the vacuum level maintained within the surgical waste receptacle 70. This is necessary to ensure that the pinch valve 62 can be actuated (as it is pneumatically controlled and engaged when required using the pressure generated by the vacuum pump 74) and to control the maximum amount of suction available at a given time in the suction system 42. The time scale of the pressure control response in the first portion 40a of the vacuum path 40 is primarily determined by the pneumatic volume available within the surgical waste receptacle 70.

[0082] Reference Fig.10, a first PID control loop 126 is implemented to control the first drain valve 54. In the first PID control loop 126, an actual pressure reading is obtained from a first sensor 48 coupled to the first portion 40a of the vacuum path 40. In this example, the first sensor 48 outputs a voltage based on the measured pressure. The voltage can be converted to a pressure reading using a voltage to pressure converter 130. The converted pressure signal is a measured waste receiver pressure signal 132.

[0083] The target waste receiver pressure signal 134 is determined based on parameters or information that may be stored in each surgical hand piece tip 30, ultrasonic surgical hand piece 28, or console 20, and a power setting from console 20. In this configuration, the target waste receiver pressure 134 is calculated from the following: the suction setting 140, the minimum hand piece pressure signal 136, and the maximum waste receiver pressure signal 138. Once calculated, the target waste receiver pressure 134 is combined with the negative value of the measured waste receiver pressure signal 132 using a first combiner 144, and the difference between the two signals 134 and 132 is the waste receiver pressure error signal 148. In other configurations, the target waste receiver pressure 134 may be compared, combined, summed, etc. with the measured waste receiver error signal 132 and the waste receiver pressure error signal 148. The waste receiver pressure error signal 148 is provided to the first PID controller 152.

[0084] The suction setting 140 and the foot pedal setting 142 are both user selections input into the console 20 .

[0085] Additionally, the first PID controller 152 receives signals indicative of a maximum first exhaust current 156 and a minimum first exhaust current 158. The first PID controller 152 then outputs a first exhaust current 164 that will cause the first exhaust valve 54 to open or close. In this configuration, the first exhaust current 164 is inverted, and a larger current will cause the first exhaust valve 54 to open more, while a lower current will cause the first exhaust valve 54 to be closed more.

[0086] In one configuration, two parameters—the maximum waste receptacle pressure 138 and the minimum hand piece pressure 136—are stored in an RFID tag or other storage device associated with each surgical hand piece tip 30. Specifically, the RFID tag may be included in a sleeve associated with each surgical hand piece tip 30. Additionally, or alternatively, the controller 102 may include a storage device 168. It will be appreciated that the storage device associated with the surgical hand piece tip 30 may be the same or a different storage device 168 associated with the controller 102. It will also be appreciated that the system 42 may include any number of storage devices.

[0087] Storing the maximum waste receiver pressure 138 and the minimum hand piece pressure 136 in the surgical hand piece tip 30 or sleeve associated with each tip provides a better system because many aspects of the system change depending on the surgical hand piece tip 30 used. The maximum pressure achievable in the system depends on the rate at which vacuum is drawn. Each surgical hand piece tip 30 has different suction characteristics and therefore different steady state pressures when the first exhaust valve 54 and the second exhaust valve 60 are fully opened and / or fully closed. Each surgical hand piece tip 30 can all be different lengths, have different pre-suction hole configurations, have different sleeve sizes, and have different geometries. This results in different absolute minimum set points and absolute maximum set points. In order to control the entire range available for each different tip, the RFID tag or other storage device carries two parameters for use by the suction control system. The maximum waste receiver pressure 138 that the control system will allow and the minimum tip pressure 136 that the control system will allow. The maximum waste receiver pressure signal 138 is stored in the suction control system. Fig.10 denoted as a pressure range which takes into account the maximum waste receiver pressure signal 138 .

[0088] The maximum waste receiver pressure signal 138 will typically be the highest pressure achievable with the first and second vent valves 54, 60 fully closed without obstructing the ultrasonic surgical hand piece tip 30. In some cases, if the tip is very open and there is a pressure differential between the lowest and highest suction conditions, the highest achievable pressure will be set above the maximum waste receiver pressure.

[0089] The minimum steady-state aspiration pressure that can be obtained is the measurement value obtained by the second sensor 57 from the second portion 40b of the vacuum path 40 when the first and second exhaust valves 54, 60 are fully open and the surgical instrument tip 30 is attached to the surgical handpiece 28 and the console 20. This value is used to set the lowest possible exhaust side pressure setting value. Without it, many lower aspiration setting values ​​will be indistinguishable from each other. That is, the pressure set point will always be below the measured pressure, so that the first and second exhaust valves 54, 60 remain fully open, and the expected set point is never reached.

[0090] Reference again Fig.10, a second PID control loop 128 is used to quickly control the suction pressure available at the ultrasonic surgical handpiece tip 30 through the second exhaust valve 60, thereby allowing a constant vacuum pressure even with rapid changes in suction load / occlusion. This is ideal for fine, precise and rapid control of the suction available to the surgeon at the tip. The time scale of pressure changes at the tip is much faster than that of the waste receptacle and is limited only by the volume of the tubing connecting the second sensor 57 to the surgical handpiece tip 30. This second PID control loop 128 operates in the same manner and with similar inputs as the first PID control loop 126.

[0091] In the second PID control loop 128, an actual pressure reading is obtained from a second sensor 57, which is coupled to the second portion 40b of the vacuum path 40 or in communication with the dirty side flow path 460. In this example, the second sensor 57 outputs a voltage signal based on the measured pressure. The voltage signal can be converted to a pressure reading using a second voltage-to-pressure conversion 131. The measured tip pressure signal 133 is combined with a target tip pressure signal 135 using a second combiner 146. The target tip pressure signal 135 is determined based on parameters stored in a storage device associated with each surgical hand piece tip.

[0092] Additionally or alternatively, the target tip pressure signal 135 can be based on a tip occlusion threshold. The tip occlusion threshold can be a parameter stored in a storage device associated with each surgical hand piece tip or in a memory 168 associated with the controller 102. Once the tip occlusion threshold is determined, the system 42 can enter into an occlusion detection system using an operating routine 300 to determine whether an occlusion is detected within the ultrasonic surgical hand piece 28. The operating routine 300 is described in more detail below.

[0093] The second PID control loop 128 calculates a target tip pressure 135 based on the suction set point 140, the foot pedal set point 142, the minimum handpiece pressure signal 136, and the maximum waste receptacle pressure signal 138, which is combined with the measured tip pressure signal 133 to generate a tip pressure error signal 150. It will be appreciated that the tip pressure error signal 150 is a tip error signal based on the tip pressure signal 133. In this configuration, the target tip pressure signal 135 is combined with the negative value of the measured tip pressure signal 133, and the difference between the two signals is the handpiece pressure error signal 150. The tip pressure error signal 150 is provided to the second PID controller 154. In addition, the second PID controller 154 receives a maximum second discharge current 160 and a minimum second discharge current 162 indicative of the second discharge valve 60. The second PID controller 154 outputs a second discharge current 166, which will cause the second discharge valve 60 to open or close. In this configuration, the second exhaust current 166 is inverted, and a larger second exhaust current 166 will cause the second exhaust valve 60 to open more, while a lower second exhaust current 166 will cause the second exhaust valve 60 to close more.

[0094] The positions of the first bleed valve 54 and the second bleed valve 60 may be stored in the memory device 168 by the console 20. Alternatively, the positions of the first bleed valve 54 and the second bleed valve 60 may be based on a comparison, combination, estimation, or mathematical relationship between the measured waste receiver pressure signal 132 and the target waste receiver pressure signal 134 and between the measured tip pressure signal 133 and the target tip pressure signal 135, respectively.

[0095] Fig.11 FIG. 1 shows an example of how target pressure signals may be set and how these signals relate to the suction setpoint 140 and the minimum handpiece pressure signal 136 and the maximum waste receiver pressure signal 138. In addition to the minimum handpiece pressure 136 and the maximum waste receiver pressure 138, Fig.11 There are two more points to consider in FIG. There is a low point marked as LP on the line showing the actual and target waste receiver pressures. While controlling at a very low aspiration set point, there is a point LP where the waste receiver pressure remains consistently above the target waste receiver pressure 134. This means that the system 42 is completely controlled by the second vent valve 60. In this case, the system 42 has a lower pressure at the tip 30, which provides the feel of a lower aspiration set point, while the aspiration line between the cassette 34 and the surgical waste receiver 70 clears at a faster rate, thereby reducing blockages.

[0096] At the higher end, at the point marked HP on the line showing actual and target handpiece pressures, the second exhaust valve 60 becomes fully closed and allows a change to a higher pressure. The response is rapid because the primary pneumatic volume of the surgical waste receptacle 70 has been fully evacuated and all that remains is the second portion 40b tubing of the vacuum path 40 itself. This allows a higher set point to quickly achieve the desired higher pressure. Under load at the higher suction set point above this point, the pressure in the system 42 quickly matches the upper portion of the control target.

[0097] Finally, as Fig.11 The curve graph and Fig.12 As can be seen from the schematic diagram in FIG. 4 , the system 42 can be designed so that a higher pressure is maintained in the first portion 40a of the vacuum path 40 than in the second portion 40b of the vacuum path 40. Additionally or alternatively, a higher pressure is maintained on the "clean side" of the system 42 than on the "dirty side" of the system 42, wherein the surgical waste receiver 70 provides a functional boundary between the two sides. In other words, a higher pressure is maintained from the surgical waste receiver 70 and the filter 72 to the vacuum pump 74, while a lower pressure is maintained at the surgical handpiece tip 30 and in the remainder of the vacuum path 40. This pressure differential is maintained by the controller 102 controlling the first exhaust valve 54 and the second exhaust valve 60. When the atmosphere enters the second portion 40b of the vacuum path 40 via the second exhaust valve 60, the pressure at the surgical handpiece tip 30 is rapidly reduced.

[0098] Fig.12 A schematic diagram of a suction system using electrical schematic connections to represent pneumatic resistance is depicted. As shown, there are three components (clean side piping, filter 72, and surgical waste receiver / tank piping) between one side of the surgical waste receiver 70 and the pinch valve 62. On the other side, there is a dirty side piping between the pinch valve 62 and the surgical waste receiver 70. On the "dirty side", two dirty side piping and a ball valve 86 / fluid return device 462 are provided. The second sensor 57 (including the differential sensor 50b and the metering sensor 52b), the second exhaust valve 60, and the diffuser are arranged to communicate with the ball valve 86 / fluid return device 462. On the "clean side", a vacuum pump 74, a first sensor 48 (including the differential sensor 50a and the metering sensor 52a), a clean side piping, a filter 72, and a surgical waste receiver / tank filter are provided. The muffler filter is arranged to communicate with the vacuum pump 74.

[0099] Due to the large volume in the surgical waste receiver 70 and the pneumatic resistance of the system 42, a higher pressure can be maintained in the first portion 40a of the vacuum path 40 for a period of time even though all portions of the vacuum path 40 are connected. The pressure differential helps ensure that surgical waste does not flow into the first portion 40a of the vacuum path 40, which is important because the tubing between the filter 72 and the vacuum pump 74 is not changed between patients.

[0100] III. Blockage Detection

[0101] During operation of the ultrasonic surgical hand piece 28, a common complication is caused by blockage or occlusion of the ultrasonic surgical hand piece tip 30. When the tip 30 is blocked, the vacuum pump 74 continues and the vacuum pressure builds up within the ultrasonic surgical hand piece 28. Eventually, when the blockage is cleared, it will break, causing the pressure to drop, resulting in a large amount of surgical waste being aspirated too quickly. This is called a post-occlusion surge. Fig.13 , the system may execute an operating routine 300 that determines whether an obstruction is detected within the surgical handpiece 28. The operating routine 300 is designed to reduce and / or prevent surges.

[0102] Utilizing readings from the first sensor 48 and the second sensor 57, respectively, to interface with the first drain valve 54 and the second drain valve 60, respectively, the operating routine 300 goes through the following steps to determine if an obstruction is detected within the surgical handpiece 28. In one configuration, the readings from the first sensor 48 and the second sensor 57 may be the first flow rate and the second flow rate, respectively.

[0103] Other advantages of the system 42 implementing the operating routine 300 include, but are not limited to, maintaining a desired tissue removal rate, automatically adjusting suction to maintain a desired flow rate for ultrasonic tissue removal, alerting the user to possible blockages, and automatically clearing blockages within the system.

[0104] Reference Fig.13 And reference Figure 2 and Fig.10 , the operating routine 300 begins at step 301, where a tip occlusion threshold may be set. In one configuration, once the system 42 is turned on and the tip of the surgical hand piece is attached, the tip occlusion threshold is calculated using a maximum pressure based on a maximum open loop response without a load. In another configuration, the tip occlusion threshold may be a parameter stored in a storage device associated with each surgical hand piece (e.g., a storage sleeve device located in a sleeve associated with the tip). The tip occlusion threshold may help determine a possible occlusion.

[0105] At step 302, the system 42 enters into a blocking control loop. At step 304, actual pressure readings are obtained from the first sensor 48 and the second sensor 57. In one configuration, the first sensor 48 and the second sensor 57 can be differential pressure sensors 50a and 50b, respectively. In other configurations, the first sensor 48 and the second sensor 57 can be flow sensors.

[0106] Then, at step 306, the readings from the first sensor 48 and the second sensor 57 may be compared to a first predetermined parameter using the first PID pressure control loop 126 or the second PID pressure control loop 128. The first predetermined parameter may be stored in a memory device associated with the tip 30 or in a memory device 168 of the controller 102. If the tip occlusion threshold is greater than the first predetermined parameter and the aspiration set point 140 is greater than a predetermined percentage limit, the operating routine 300 proceeds to step 308. The predetermined percentage limit may be a percentage stored in a memory device associated with the surgical hand piece tip 30 or in a memory device 168 of the controller 102.

[0107] At step 308 , the controller 102 may indicate that a possible obstruction has been detected within the surgical handpiece 28 , and the operating routine 300 proceeds to step 310 .

[0108] At step 310, first vacuum pressure readings 180 and second vacuum pressure readings 182 are obtained from first sensor 48 and second sensor 57. More specifically, differential pressure sensor 50a of first sensor 48 and differential pressure sensor 50b of second sensor 57 output first sensor input signal 232 and second sensor input signal 233 based on a pressure change or pressure drop within first portion 40a and second portion 40b of vacuum path 40, respectively.

[0109] Then, at step 312, the first flow rate and the second flow rate are estimated based on the pressure readings from the first sensor 48 and the second sensor 57, respectively. In one configuration, the controller 102 can estimate the first flow rate based on the input signal from the differential pressure sensor 50a. Similarly, the controller 102 can estimate the second flow rate based on the input signal from the differential pressure sensor 50b. Alternatively, in a configuration where the first sensor 48 and the second sensor 57 are flow meters, the controller 102 can determine the first flow rate and the second flow rate based on the flow readings from the first sensor 48 and the second sensor 57.

[0110] In order to calibrate the position of the first drain valve 54 to the first flow rate, the operating routine 300 can repeatedly estimate the position of the first drain valve 54. At step 314, if the first drain valve 54 is closed, the operating routine 300 proceeds to step 316, where the first flow rate is set to zero. If the first drain valve 54 is open, the operating routine 300 proceeds to step 318.

[0111] At step 318, the second vacuum pressure 182 is estimated to calibrate the second flow rate. If the second vacuum pressure 182 at the second sensor 57 is less than the second predetermined parameter, the operating routine 300 proceeds to step 320, where the second flow rate is set to zero. The second predetermined parameter may be a parameter stored in any of the aforementioned storage devices 168, 169. In one configuration, the second predetermined parameter is a unit pressure expressed in pounds per square inch of area (PSI). For example, the second predetermined parameter may be 0.005 PSI.

[0112] Once the first flow rate and the second flow rate are calibrated at step 322, the controller 102 estimates the tip flow rate based on the second flow rate. The controller 102 then continuously estimates the tip flow rate over a first predetermined period of time using input from the timer to determine an average tip flow rate. As previously described, the reading from the second sensor 57 is more representative of the actual reading at the surgical handpiece tip 30, and thus the tip flow rate can be estimated using the second flow rate. Fig.10 As shown in , a timer is coupled to the controller 102. The timer is operable to time the duration of the tip occlusion signal.

[0113] The average tip flow rate may be calculated using a rolling average of the tip flow rate. In other words, the controller 102 samples the tip flow rate over a first predetermined time period and stores a certain number of tip flow rate readings in a rolling window. Once a certain number of tip flows have been included in the rolling window, the older samples are replaced with the latest tip flow samples before the latest average is calculated. For example, the first predetermined time period is 3 seconds and the certain number is 5. Therefore, the rolling average is calculated over 5 samples of tip flow per second, wherein one tip flow rate is discarded every 3 seconds. It will be appreciated that the predetermined time period may be stored in a storage device associated with the tip 30 of the ultrasonic surgical handpiece 28, a memory 168 associated with the controller 102, or any other memory.

[0114] At step 324, the average tip flow is compared to the tip occlusion threshold. If the average tip flow is less than the tip occlusion threshold, the operation routine 300 proceeds to step 328. If the average tip flow is greater than the tip occlusion threshold, the operation routine 300 proceeds to step 326, where the timer is reset or cleared and the tip occlusion signal is reset. In other words, the controller 102 has determined that there is no occlusion within the surgical handpiece 28, and the operation routine 300 proceeds back to step 302.

[0115] In another configuration, the average tip flow rate can be compared to a third predetermined parameter. The third predetermined parameter can be a parameter stored in any of the aforementioned storage devices. Similar to the comparison with the tip blockage threshold, if the average tip flow rate is greater than the third predetermined parameter, the timer and the tip blockage signal are reset or cleared. The operation routine 300 proceeds back to step 302.

[0116] If the average tip flow is less than the tip occlusion threshold or the third predetermined parameter, the operational routine 300 proceeds to step 328. At steps 328-330, if the timer is not running, the timer is started or incremented from a zero time start value.

[0117] Using the timer, the operating routine 300 then estimates the average tip flow rate over the second predetermined period of time at step 332. If the average tip flow rate is less than the tip occlusion threshold or the third predetermined parameter persists longer than the second predetermined period of time, the controller 102 outputs a tip occlusion signal at step 334.

[0118] If a tip occlusion signal is output from the operating routine 300, the controller 102 indicates that an obstruction has been detected within the surgical handpiece 28 or at the tip of the surgical handpiece 28. The user and / or the controller can then determine the next steps to clear the obstruction and maintain the desired tissue removal rate. In one configuration, when the tip occlusion signal is output, the controller 102 can automatically adjust the position of the first exhaust valve and the second exhaust valve, control the vacuum level of the vacuum pump 74, adjust the suction set point, or any combination thereof. For example, Fig.10 As shown in , the tip block signal is one of the inputs of the second PID controller. The controller 102 can control the position of the second exhaust valve 60 based on the input of the tip block signal.

[0119] Once the tip occlusion signal is output at step 334 , the operating routine 300 returns to step 302 , where the operating routine 300 may return to the occlusion control loop. This enables the system 42 to automatically execute the operating routine 300 to detect a possible occlusion within the surgical handpiece 28 .

[0120] It will be further understood that the terms "including," "comprising," and "containing" have the same meanings as the terms "comprising," "including," and "containing."

[0121] For the purposes of the description herein, it will be understood that the present disclosure may take a variety of alternative orientations unless expressly indicated to the contrary. It is also understood that the specific devices and processes shown in the drawings and described in the following patent specification are merely exemplary configurations of the inventive concepts defined herein. Therefore, unless otherwise expressly stated in the claims, specific dimensions and other physical characteristics related to the configurations disclosed herein should not be considered limiting.

[0122] Terms:

[0123] i. A suction system for controlling vacuum pressure in an ultrasonic surgical handpiece to improve control responsiveness during suction, the system comprising:

[0124] a console for fluidly coupling to an ultrasonic surgical handpiece, the console comprising a controller, a vacuum pump, a first sensor, a fluid return device, a second sensor, a clean side drain mechanism, and a second drain mechanism;

[0125] The controller is configured to control the net-side discharge mechanism based on an input signal from the first sensor; and

[0126] The controller is configured to control the second exhaust mechanism based on an input signal from a second sensor.

[0127] ii. A suction system for controlling vacuum pressure in an ultrasonic surgical handpiece to improve responsiveness during suction, the system comprising:

[0128] a console for fluidly coupling to an ultrasonic surgical handpiece, the console comprising a controller, a vacuum pump, a first exhaust mechanism, and a second exhaust mechanism, the system being configured to be placed in communication with a surgical waste receptacle;

[0129] The controller is configured to control the second drain mechanism in response to aspiration of liquid matter and solid matter through the surgical handpiece, and the controller is configured to control the first drain mechanism to maintain a desired pressure in the surgical waste receptacle.

[0130] iii. A suction system for controlling vacuum pressure in an ultrasonic surgical handpiece, the system comprising:

[0131] Vacuum pump;

[0132] a connector defining a first connector port, a second connector port, and a third connector port, the first connector port being used to couple to a first flow path extending from the ultrasonic surgical handpiece;

[0133] a second flow path coupled to the second connector port and to the surgical waste receiver port;

[0134] a third flow path coupled to the third connector port;

[0135] a fourth flow path coupled to the second surgical waste receiver port;

[0136] a first sensor coupled to the fourth flow path and configured to provide a first signal;

[0137] a second sensor coupled to the third flow path and configured to provide a second signal; and

[0138] A controller is configured to output a tip block signal based on the first signal and the second signal, and control the vacuum pump based on the tip block signal.

[0139] iv. A suction system for controlling vacuum pressure in an ultrasonic surgical handpiece, the system comprising:

[0140] A control console including a vacuum pump;

[0141] a connector defining a first connector port, a second connector port, and a third connector port, the first connector port being used to couple to a first flow path extending from the ultrasonic surgical handpiece;

[0142] a second flow path coupled to the second connector port and to the surgical waste receiver port;

[0143] a third flow path coupled to the third connector port;

[0144] a fourth flow path coupled to the second surgical waste receiver port;

[0145] a first sensor coupled to the fourth flow path and configured to provide a first signal;

[0146] a second sensor coupled to the third flow path and configured to provide a second signal;

[0147] a first discharge valve coupled to the fourth flow path;

[0148] a second discharge valve coupled to the third flow path; and

[0149] A controller is configured to determine a first flow rate based on the first signal and a second flow rate based on the second signal, output a tip block signal based on the first signal and the second signal, and control a position of the first exhaust valve and / or a position of the second exhaust valve based on the tip block signal.

[0150] v. A method for controlling vacuum pressure in an ultrasonic surgical handpiece, the method comprising:

[0151] driving a vacuum pump to generate vacuum pressure in the suction system;

[0152] determining a first flow rate of a dirty-side flow path, the dirty-side flow path being positioned between an ultrasonic surgical hand piece and a fluid return device;

[0153] determining a second flow rate of a clean-side flow path, the clean-side flow path being positioned between the vacuum pump and the surgical waste receptacle;

[0154] outputting a tip blockage signal based on an average tip flow rate, the average tip flow rate being based on the first flow rate and the second flow rate; and

[0155] The vacuum pump is controlled based on the tip blockage signal.

[0156] vi. A fluid management system, comprising:

[0157] a console defining a cassette aperture and having two pneumatic console ports in the console;

[0158] a vacuum source connected to or integrated into the console and in communication with a first one of the pneumatic console ports;

[0159] a first pressure sensor integrated into the console and in communication with a second one of the pneumatic console ports;

[0160] a second pressure sensor integrated into the console and in communication with the first pneumatic console port; and

[0161] A cassette for selectively slidable deployment within a cassette aperture and comprising:

[0162] a substantially rigid housing defining a chamber therein;

[0163] a liquid delivery portion of the pump, which includes an inlet side of the pump and an outlet side of the pump;

[0164] a plurality of fluid channels disposed at least partially within the chamber, comprising:

[0165] a first fluid passage including a first end connected to the inlet side and a second end for connecting to a supply fluid container;

[0166] a second fluid channel including a first end connected to the output side and a second end for connecting to the handpiece;

[0167] a third fluid channel including a first end for connection to the handpiece and a second end for connection to a waste container;

[0168] a fourth fluid passageway including a first end connected to a first console connector of the housing and a second end for connecting to a waste container, wherein the first console connector has a first pneumatic connector port that pneumatically connects with the first pneumatic console port when the cassette is installed in the cassette aperture; and

[0169] a fifth fluid passage having a first end connected to the third fluid passage and a second end connected to a second console connector of the housing, wherein the second console connector has a second pneumatic connector port that pneumatically connects with the second pneumatic console port when the cassette is installed in the cassette aperture.

[0170] vii. A method of using a surgical flushing cassette, comprising the steps of:

[0171] Surgical irrigation cassettes are available with:

[0172] a substantially rigid housing defining a chamber therein,

[0173] a compressible peristaltic pump tube arranged outside the housing,

[0174] a plurality of fluid channels at least partially disposed within the chamber, comprising:

[0175] a first fluid channel including a first end connected to the first end of the pump tube and a second end for connecting to a supply fluid container,

[0176] a second fluid channel including a first end connected to the second end of the pump tube and a second end for connecting to the handpiece,

[0177] a third fluid channel including a first end for connection to the handpiece and a second end for connection to a waste container,

[0178] a fourth fluid channel including a first end connected to the first console connector fixed to the housing and a second end for connecting to a waste container, and

[0179] a fifth fluid passage having a first end connected to the third fluid passage and a second end connected to a second console connector fixed to the housing;

[0180] inserting the cassette into a console containing or connected to a vacuum source;

[0181] connecting a second end of the first fluid passageway to a supply fluid container;

[0182] connecting a second end of the second fluid channel to the handpiece;

[0183] connecting a first end of a third fluid channel to the handpiece;

[0184] connecting the second end of the third fluid channel to a waste container; and

[0185] Connect a second end of the fourth fluid channel to a waste container.

[0186] Several embodiments have been discussed in the foregoing description. However, the embodiments discussed herein are not intended to be exhaustive or to limit the present disclosure to any particular form. The terms used are intended to have the nature of descriptive words rather than to be restrictive. In view of the above teachings, many modifications and variations are possible, and the present disclosure may be practiced in a manner different from that specifically described.

Claims

1. An aspiration system for controlling vacuum pressure in an ultrasonic surgical handpiece to obtain improved control responsiveness during aspiration, the system comprising: Vacuum pump; a vacuum path extending at least partially between a surgical hand piece connector and the vacuum pump, the vacuum path further comprising a joint, wherein the joint divides the vacuum path into at least two flow paths; a first sensor coupled to a first portion of the vacuum path, the first portion of the vacuum path being disposed between a surgical waste receiver connector and the vacuum pump, the first sensor being configured to monitor a waste receiver pressure and provide a waste receiver pressure signal; a first drain valve coupled to a first portion of the vacuum path; a second drain valve coupled to a terminal end of a second portion of the vacuum path originating from the joint; a second sensor coupled to a second portion of the vacuum path and configured to monitor vacuum pressure associated with a tip of the ultrasonic surgical hand piece and provide a tip pressure signal; and A controller is configured to control a position of the first drain valve based on the waste receptacle pressure signal and to control a position of the second drain valve based on the tip pressure signal.

2. The suction system of claim 1, wherein: The joint includes a joint valve operable to divide the vacuum path, the joint valve having a first joint port, a second joint port, and a third joint port to which the second portion of the vacuum path is coupled.

3. The suction system of claim 2, wherein: The connector valve is a ball valve that prevents surgical waste from entering the second portion of the vacuum path.

4. The suction system of claim 2, wherein: A third portion of the vacuum path is coupled to the second connector port and to the surgical waste receptacle connector of a surgical waste receptacle.

5. A suction system as claimed in any one of the preceding claims, wherein: The aspiration system also includes a cassette for being fluidly coupled to the ultrasonic surgical hand piece, the cassette including an opening to a third portion of the vacuum path, the opening being aligned with a pinch valve operable to prevent vacuum pressure from reaching the tip of the ultrasonic surgical hand piece.

6. The suction system of claim 5, wherein: The cassette also includes an irrigation line for coupling the ultrasonic surgical handpiece to an irrigation source.

7. A suction system as claimed in any one of the preceding claims, wherein: The aspiration system also includes the ultrasonic surgical handpiece.

8. A suction system as claimed in any one of the preceding claims, wherein: The first portion of the vacuum path comprises a clean side flow path and the second portion of the vacuum path comprises a dirty side flow path.

9. A suction system as claimed in any one of the preceding claims, wherein: The first portion of the vacuum path has a larger volume than the second portion of the vacuum path.

10. A suction system as claimed in any one of the preceding claims, wherein: The first portion of the vacuum path has a greater compliance under pressure than the second portion of the vacuum path.

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