Insufflator safety valve with electrically variable opening pressure

Abstract

An insufflator for delivering a surgical gas from a gas source to a patient body cavity during a surgical procedure, the insufflator comprising an electrically powered variable safety valve adapted and configured to prevent over-pressurization of the patient body cavity during the surgical procedure by venting the surgical gas in the patient body cavity to atmosphere when an opening pressure of the variable safety valve is exceeded.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Patent Application Serial No. 63 / 246,018, filed September 20, 2021, the entire disclosure of which is incorporated herein by reference. Background Technology 1. Technical Field

[0004] This application relates to endoscopic surgery, and more specifically to an insulator for delivering surgical gas into a patient's body cavity, the insulator including a safety valve with an electrically adjustable opening pressure.

[0005] 2. Relevant Technical Descriptions

[0006] Laparoscopic or “minimally invasive” surgical techniques are becoming increasingly common in procedures such as cholecystectomy, appendectomy, hernia repair, and nephrectomy. These procedures typically involve filling or “inflating” the abdominal cavity with pressurized fluids such as carbon dioxide to create a surgical space known as pneumoperitoneum.

[0007] Pneumoperitoneum administration associated with laparoscopic surgery carries an inherent patient risk associated with overpressure of the abdominal cavity. Overpressure has caused injury to many patients, including adults and children. Most pneumoperitoneum devices currently in use include a separate mechanical safety valve installed at an intermediate pressure point in the pneumoperitoneum network. The safety valve serves as a final safeguard against mechanical, electrical, and software malfunctions that could cause pressure to exceed the pneumoperitoneum control setpoint.

[0008] While known insufflator safety valves in the prior art are adjustable, they are typically fixed to a specified value or opening pressure only during manufacturing or subsequent maintenance. This non-user-adjustable characteristic of the valve necessitates setting it above the maximum expected normal pressure level to prevent intermittent leakage during surgical use. When used with most patient populations, these leak-proof pressure setpoints are typically higher than the threshold for mitigating overpressure in most applications.

[0009] Advantageously, an insufflator safety valve is provided, wherein the valve's opening pressure or set point can be adjusted intraoperatively. This adjustability allows the opening pressure to be set much lower than that of safety valves described in the prior art, without requiring frequent valve opening. Furthermore, the opening pressure can be reduced for procedures requiring less gas flow or for patients with smaller peritoneal volumes (such as children). Summary of the Invention

[0010] This disclosure relates to a novel and useful blower for delivering surgical gas from a gas source into a patient's body cavity during surgical procedures. The blower includes an electrically operated variable safety valve adapted and configured to prevent overpressure of the patient's body cavity during surgery by venting surgical gas from the body cavity to the atmosphere when the opening pressure of the variable safety valve exceeds its opening pressure. In use, the valve "opens" and gas flows when the pressure difference across the valve exceeds the opening pressure.

[0011] According to this disclosure, the variable safety valve includes: an electric motor for adjusting the opening pressure of the variable safety valve during surgery; and a motor controller for commanding the electric motor to adjust the opening pressure of the variable safety valve based on a feedback signal. In one embodiment of this disclosure, the feedback signal is provided by an input signal from an operator. In another embodiment, the feedback signal is provided by a signal from a sensor.

[0012] When the input signal is provided by the operator, the motor controller commands the electric motor to adjust the opening pressure of the variable safety valve based on the operator-selected opening pressure chosen from a set of at least two discrete opening pressure setpoints. When the signal is provided by a sensor, the motor controller commands the electric motor to adjust the opening pressure of the variable safety valve based on feedback signals from a flow sensor and / or a pressure sensor.

[0013] The blower also includes: a flow sensor for monitoring the flow rate of surgical gas delivered to the patient's body cavity; a pressure sensor for monitoring the pressure of surgical gas delivered to the patient's body cavity; a control valve for controlling the delivery of surgical gas from the blower to the patient's body cavity; and a pressure regulator for controlling the pressure of surgical gas delivered from a gas source to the blower.

[0014] According to this disclosure, the electric motor is a stepper motor that drives a guide nut, which converts rotary motion into linear motion by means of a guide screw. The guide screw drives a pressure plate that contacts one end of the valve spring, thereby effectively changing the installation length of the valve spring. Shortening the installation length of the valve spring is linearly related to increasing the opening pressure of the variable safety valve, which allows gas flow when the gas pressure applied to the front side of the diaphragm exceeds the spring force applied to the back side of the diaphragm.

[0015] These and other features of the electrically operated variable blow-in safety valve of this disclosure will become more apparent from the following detailed description of the preferred embodiment in conjunction with the accompanying drawings. Attached Figure Description

[0016] To enable those skilled in the art to readily understand how to manufacture and use the blow-in safety valve of this disclosure without excessive experimentation, its embodiments will now be described in detail with reference to the accompanying drawings, wherein:

[0017] Figure 1 This is a schematic diagram of an insulator constructed according to this disclosure; and

[0018] Figure 2 This is a cross-sectional view of the electrically variable safety valve disclosed herein, which is integrated with... Figure 1 In the blower shown. Detailed Implementation

[0019] Referring now to the accompanying drawings, wherein the same reference numerals denote similar features or parts of this disclosure, Figure 1 The diagram shows a schematic of an insulator control console 10 incorporating the variable safety valve 100 of this disclosure. The insulator control console 10 receives pressurized surgical gas from a gas supply source 12 and delivers the pressure-regulated surgical gas to the patient's body cavity via a tubing assembly 14 communicating with a valve-sealed inlet port or a cannula needle 16.

[0020] The blower 10 includes a graphical user interface 18 or GUI and a microprocessor or motor controller 20 for controlling the variable safety valve 100 and the separate flow control valve 22 based on user input via the GUI 18 and feedback signals from the flow sensor 24 and / or the pressure sensor 26.

[0021] In use, surgical gas entering the insulator console 10 from the gas supply 12 initially passes through the high-pressure regulator 28 and then through the medium-pressure regulator 30. The gas flow then interacts with the flow sensor 24 and the pressure sensor 26 before flowing to the control valve 22, which moderates or otherwise controls the delivery of gas from the insulator console 10 to the tubing 14 and is attached to the valve-sealed inlet port 16.

[0022] The variable safety valve 100 of this disclosure is located downstream of the medium-pressure regulator 30 and upstream of the flow sensor 24. This variable safety valve is adapted and configured to, when actuated, direct gas from the patient's abdominal cavity or otherwise expel it from the insufflator console 10 and into the surrounding atmosphere, thereby advantageously preventing overpressure of the patient's abdominal cavity. As explained in more detail below, the variable safety valve 100 is actuated when the pressure difference across the valve exceeds the valve's opening pressure or the pneumoperitoneum control setpoint.

[0023] It is conceivable that the variable safety valve 100 of this disclosure can be incorporated into a low-pressure blow-in manifold of a multi-mode gas delivery system disclosed in commonly assigned U.S. Patent Application Publication 2022 / 0233791, the entire disclosure of which is incorporated herein by reference.

[0024] Now for reference Figure 2 The variable safety valve 100 includes a base 102 and a housing 104. The housing is connected to the base 102 by threaded fasteners 105. The base 102 of the valve 100 has an internal pressure chamber 106 that communicates with the gas delivery flow path of the blower 10 downstream of the intermediate pressure regulator 30 and upstream of the flow sensor 24, as shown below. Figure 1 As shown. The base 102 also has an exhaust port 108, which communicates with the pressure chamber 106 and the surrounding atmosphere.

[0025] The flow control element of the safety valve 100 is a lift valve member 118, which is associated with a valve seat 120 located between the pressure chamber 106 and the exhaust port 108 and secured in place by a locking ring 125. The lift valve member 118 is operatively associated with a flexible diaphragm 126 that extends through the inner pressure chamber 106 and is securely fixed around its outer periphery between the base 102 and the valve housing 104. The front side of the diaphragm 126 defines the upper boundary of the pressure chamber 106 and will respond to pressure changes therein.

[0026] The rear or back side of the diaphragm 126 is operably associated with a helical valve spring 116 supported by an internal chamber 115 of the housing 104 of the valve 100. The helical valve spring 116 is sandwiched between an upper pressure plate 122 and a lower pressure plate 124. The lower pressure plate 124 is operably associated with the back side of the diaphragm 126, while the upper pressure plate 122 is operably connected to an electric motor (e.g., a stepper motor) 112. The upper pressure plate 122 is connected to the electric motor 112 by means of a torque / force multiplier drive mechanism in the form of a guide screw 114.

[0027] Those skilled in the art will readily appreciate that motor 112 need not be a stepper motor, as any electric motor with position feedback can be substituted. However, a stepper motor is desirable because the position can be controlled by step inputs, thus eliminating the need for a position feedback loop. Those skilled in the art will also appreciate that the drive mechanism need not be linear or translated into linear motion. Alternatives combining gears, rotary actuation, and nonlinear springs are also envisioned, and these alternatives are entirely within the scope of this disclosure.

[0028] During operation, when the opening pressure of valve 100 is adjusted during surgery, stepper motor 112 drives guide nut (not shown), which converts rotational motion into linear motion via guide screw 114. The guide screw's movement drives upper pressure plate 122 to contact the upper end of valve spring 116, effectively changing the installation length of valve spring 116 within valve housing 104. Shortening the installation length of valve spring 116 is linearly related to increasing the opening pressure of safety valve 100. This variable safety valve allows gas flow when the gas pressure acting on the front of diaphragm 126 within pressure chamber 106 exceeds the spring force applied to the back of diaphragm 126 by valve spring 116.

[0029] In one embodiment of this disclosure, a user or operator can select the opening pressure of valve 100 from at least two discrete opening pressure setpoints using the graphical user interface 18 of the blower 10. In another embodiment of this disclosure, the operator can continuously select from a set of selectable setpoints across the entire opening pressure range. In yet another embodiment of this disclosure, the opening pressure of valve 100 is continuously and automatically set by processor / motor controller 20 based on feedback signals from flow sensor 24 and / or pressure sensor 26. This automatic control facilitated by processor 20 can be implemented using appropriate circuitry with or without associated software.

[0030] This disclosure eliminates the user-based setpoint decision process and enables the blow-in system to proactively adapt to downstream configuration (e.g., tubing, valves, inlet ports, etc.) and patient changes by monitoring pressure, flow rate, or combinations thereof. For example, the blow-in system can set an initial opening pressure of 5 mmHg at a low opening pressure to maintain a high level of overpressure safety, and automatically increase the opening pressure setpoint as the gas delivery rate measured at flow sensor 24 increases or the intermediate node pressure measured at pressure sensor 26 increases, while never allowing the setpoint to exceed a maximum level of 80 mmHg or a lower user-selected / configurable value.

[0031] In this scenario, if a fault occurs that could lead to an overpressure hazard, the setpoint or opening pressure will never exceed the 80 mmHg threshold, and when considered as a fluctuation over time, the opening pressure at the time of the fault may be closer to the pneumoperitoneum setpoint than the 80 mmHg upper limit.

[0032] Although this disclosure has been shown and described with reference to preferred embodiments, those skilled in the art will readily understand that changes and / or modifications can be made thereto without departing from the scope of this disclosure.

Claims

1. A blower for delivering surgical gas from a gas source into a patient's body cavity during surgical procedures, the blower comprising: An electrically operated variable safety valve disposed within the insufflator is adapted and configured to expel surgical gas from the patient's body cavity into the surrounding atmosphere when the opening pressure of the variable safety valve exceeds the pressure of the insufflator, thereby preventing overpressure of the patient's body cavity during the surgical procedure. The variable safety valve has an internal pressure chamber in communication with the gas flow path of the insufflator and is in communication with the surrounding atmosphere via an exhaust port. A valve member is located between the internal pressure chamber and the exhaust port and is operably associated with a flexible diaphragm extending through the internal pressure chamber.

2. The blower of claim 1, wherein the variable safety valve comprises an electric motor for adjusting the opening pressure of the variable safety valve during surgery.

3. The blower according to claim 2 further includes a motor controller, the motor controller being configured to command the electric motor to adjust the opening pressure of the variable safety valve based on a feedback signal.

4. The blower of claim 3, wherein the feedback signal is provided by an input signal from the operator.

5. The blower of claim 3, wherein the feedback signal is provided by a signal from a sensor.

6. The blower of claim 4, wherein the motor controller commands the electric motor to adjust the opening pressure of the variable safety valve based on an operator-selected opening pressure selected from a set of at least two discrete opening pressure setpoints.

7. The blower of claim 5, wherein the motor controller commands the electric motor to adjust the opening pressure of the variable safety valve based on feedback signals from a flow sensor and / or a pressure sensor.

8. The blower of claim 7 further includes a flow sensor for monitoring the flow rate of the surgical gas delivered to the patient's body cavity.

9. The blower of claim 7 further includes a pressure sensor for monitoring the pressure of the surgical gas delivered to the patient's body cavity.

10. The blower of claim 1, further comprising a control valve for controlling the delivery of surgical gas from the blower to the patient's body cavity.

11. The blower of claim 1, further comprising a pressure regulator for controlling the pressure of the surgical gas supplied from the gas source to the blower.

12. The blower according to claim 2, wherein the electric motor is a stepper motor that converts rotational motion into linear motion by means of a guide screw.

13. The blower of claim 12, wherein the guide screw drives a pressure plate in contact with one end of the valve spring, thereby effectively changing the installation length of the valve spring.

14. The blower of claim 13, wherein shortening the mounting length of the valve spring is linearly related to increasing the opening pressure of the variable safety valve, wherein the variable safety valve allows gas flow when the gas pressure acting on the front side of the diaphragm exceeds the spring force applied to the back side of the diaphragm.

15. An insulator for delivering surgical gas from a gas source to a patient's body cavity during surgical procedures, the insulator comprising: a) A variable safety valve disposed within the insufflator, the variable safety valve being adapted and configured to discharge surgical gas from the patient's body cavity into the insufflator and into the surrounding atmosphere when the opening pressure of the variable safety valve exceeds the pressure of the variable safety valve, thereby preventing overpressure of the patient's body cavity during the surgical procedure, wherein the variable safety valve has an internal pressure chamber in communication with the gas flow path of the insufflator and the internal pressure chamber is in communication with the surrounding atmosphere via an exhaust port, and wherein a valve member is located between the internal pressure chamber and the exhaust port, and the valve member is operatively associated with a flexible diaphragm extending through the internal pressure chamber; b) An electric motor for adjusting the opening pressure of the variable safety valve during surgery; and c) A motor controller, which commands the electric motor to adjust the opening pressure of the variable safety valve based on an opening pressure selected by the operator.

16. The blower of claim 15, wherein the operator-selected opening pressure is selected from a set of at least two discrete opening pressure setpoints.

17. An insulator for delivering surgical gas from a gas source to a patient's body cavity during surgical procedures, the insulator comprising: a) A variable safety valve disposed within the insufflator, the variable safety valve being adapted and configured to discharge surgical gas from the patient's body cavity into the insufflator and into the surrounding atmosphere when the opening pressure of the variable safety valve exceeds the pressure of the variable safety valve, thereby preventing overpressure of the patient's body cavity during the surgical procedure, wherein the variable safety valve has an internal pressure chamber in communication with the gas flow path of the insufflator and the internal pressure chamber is in communication with the surrounding atmosphere via an exhaust port, and wherein a valve member is located between the internal pressure chamber and the exhaust port, and the valve member is operatively associated with a flexible diaphragm extending through the internal pressure chamber; b) An electric motor for adjusting the opening pressure of the variable safety valve during surgery; and c) A motor controller, which commands the electric motor to adjust the opening pressure of the variable safety valve based on feedback signals from a sensor.

18. The blower of claim 17, wherein the feedback signal is generated by a flow sensor and / or a pressure sensor.

19. The blower of claim 18 further includes a flow sensor for monitoring the flow rate of the surgical gas delivered to the patient's body cavity.

20. The blower of claim 18 further includes a pressure sensor for monitoring the pressure of the surgical gas delivered to the patient's body cavity.

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