Endoscope with pressure sensing tip

Abstract

The endoscope can include a handle for holding and controlling the endoscope and an elongate member extending from a distal section of the handle. The elongate member can include a lumen extending from a proximal portion of the elongate member to a distal portion of the elongate member. The pressure sensor can be coupled to the distal portion of the elongate member and can be configured to detect pressure.

Description

[0001] Priority requirements

[0002] This patent application claims the benefit of priority to U.S. Patent Application Serial No. 63 / 602,728 (Attorney’s File No. 5409.913PRV), filed November 27, 2023, entitled “ENDOSCOPE WITH A PRESSURE SENSING TIP”, pursuant to 35 USC 119(e), which is incorporated herein by reference in its entirety. Technical Field

[0003] The examples described in this article generally relate to endoscopes, and more specifically to endoscopes with pressure sensing capabilities. Background Technology

[0004] Conventional endoscopy can be used in a variety of clinical procedures, including, for example: illumination, imaging, detection and diagnosis of one or more disease states; delivery of fluids toward anatomical regions (e.g., saline or other preparations via a fluid channel); provision of access to one or more therapeutic devices (e.g., via a working channel) for sampling or processing of anatomical regions; provision of aspiration access for collecting fluids (e.g., saline or other preparations), etc. Such anatomical regions may include the digestive tract (e.g., esophagus, stomach, duodenum, pancreaticobiliary ducts, intestines, colon, etc.), renal regions (e.g., kidneys, ureters, bladder, urethra), other internal organs (e.g., reproductive system, sinus cavities, submucosal regions, respiratory tract), etc. Summary of the Invention

[0005] In the example, the endoscope system may include a control system configured to control components of the endoscope system. The endoscope system may also include an endoscope configured to be inserted into a patient during a medical procedure. The endoscope may include a handle for holding and controlling the endoscope during the medical procedure and an elongated member extending from a distal portion of the handle. The elongated member may include a lumen extending from a proximal portion of the elongated member to a distal portion of the elongated member. A pressure sensor may be coupled to the distal portion of the elongated member and configured to detect pressure at a target site during the medical procedure.

[0006] In the example, the endoscope can be configured to be inserted into a patient during a medical procedure. The endoscope may include a handle for holding and controlling the endoscope during the medical procedure, and an elongated member extending from a distal segment of the handle. The elongated member may include a lumen extending from a proximal portion of the elongated member to a distal portion of the elongated member. A pressure sensor may be coupled to the distal portion of the elongated member and may be configured to detect pressure at a target site during the medical procedure.

[0007] In the example, a method of forming an endoscope may include coupling a first pressure sensor to a distal portion of an elongated member. The elongated member may include a lumen extending from the distal portion to a proximal portion. The first pressure sensor may be configured to detect pressure at a target site. A second pressure sensor is coupled to the elongated member proximally relative to the first pressure sensor. The method may further include connecting the first and second pressure sensors to a pressure signal monitoring circuit using electrodes. Attached Figure Description

[0008] Various examples are shown in the accompanying figures. Such examples are illustrative and are not intended to be exhaustive or exclusive examples of the subject matter.

[0009] Figure 1 This is a schematic diagram of an example of a medical device system.

[0010] Figure 2 This is a schematic diagram of an example of an imaging and control system for a medical device system.

[0011] Figure 3 This is a schematic diagram of an example endoscope.

[0012] Figure 4 This is a block diagram of an example endoscope system.

[0013] Figure 5 This is a block diagram of an example endoscope system.

[0014] Figure 6 This is a schematic diagram of an example of an endoscope system.

[0015] Figure 7 This is a schematic diagram of an example endoscope.

[0016] Figure 8 It is a graphical representation indicating the pressure signal along the example elongated member.

[0017] Figure 9 This is a schematic diagram of an example of a computer-based clinical decision support system (CDSS).

[0018] Figure 10 It is a block diagram showing an example of a machine on which one or more examples can be implemented.

[0019] Figure 11 This is a block diagram illustrating an example method for forming an endoscope. Detailed Implementation

[0020] Intrarenal pressure can cause renal pelvic venous reflux during medical procedures. This reflux may increase the likelihood of sepsis during the patient's postoperative recovery period. To help measure intrarenal pressure during medical procedures, endoscopes may include integrated pressure sensors. This disclosure discusses an endoscope that can accurately measure pressure near the distal end to determine intrarenal pressure in a patient during medical procedures.

[0021] According to this disclosure, an endoscope may include a pressure sensor that uses a piezoelectric material applied to, fabricated on, or covering the distal end surface of the endoscope tip. The piezoelectric material generates a series of electrical signals when pressure is applied; therefore, the piezoelectric material used in the pressure sensor enables the sensor to detect pressure near the endoscope tip surface. Piezoelectric pressure sensors may include lead zirconate titanate (PZT), quartz, aluminum nitride, etc.

[0022] The endoscope may include electrodes (e.g., conductive wires) made of highly conductive or flexible materials such as, for example, gold, copper, or aluminum. The electrodes may be fabricated to be arranged along the endoscope axis and connected to a piezoelectric pressure sensor. The electrodes may be located wholly or partially outside or inside the endoscope axis. The electrodes may be coupled to pressure monitoring circuitry to measure the electrical signal generated by the piezoelectric pressure sensor. The pressure monitoring circuitry may be mounted within the endoscope handle or on any component external to the endoscope but wirelessly or via a wired connection to the endoscope system. A biocompatible conformal coating may encapsulate the electrodes and the piezoelectric layer.

[0023] The sampling device can be inserted directly into the patient or via another endoscope (e.g., a bronchoscope), creating an endoscope-accessory relationship (sometimes referred to as a parent-child relationship) between the bronchoscope and the sampling device. Thus, the endoscope can be inserted into the desired location within the patient. After the endoscope is in the desired position, the sub-device (e.g., the sampling device) can be inserted into the endoscope (e.g., via a working channel) and extend from the distal end of the endoscope. The diameter of the sub-device can be smaller than that of the endoscope, allowing it to extend into the patient access area, which is smaller in diameter than the endoscope. The sub-device (e.g., the sampling device) can extend from the distal end of the endoscope to a target area within the patient, and instruments of the sub-device (e.g., biopsy needles, ablation probes, etc.) can be deployed to extend from the distal end of the sub-device and obtain tissue samples from the patient and / or process the patient's tissue (e.g., via ablation, drug delivery, etc.). Although other use cases are considered, this paper primarily discusses the sub-device in the specific context of a sampling device that includes a side outlet port such that the instrument is a biopsy needle that can be extended at an angle relative to the longitudinal axis of the sampling device into the patient's tissue.

[0024] The foregoing discussion is intended to provide an overview of the subject matter of this patent application. It is not intended to provide an exclusive or exhaustive description of the contents of this disclosure. The following description is included to provide additional information regarding this patent application.

[0025] Figure 1 This is a schematic diagram of an endoscope system 100, which may include: a control system 102; and an endobronchial ultrasound sampling device, which includes an endoscope 104 and a medical device 108, which may be attached to the endoscope 104 and includes a distal portion 110 extending from the distal end of the endoscope 104 via a distal working channel port (e.g., working channel port 112). Figure 1 The system described herein is an illustrative example of an endoscope system suitable for use with the systems, apparatus and methods described herein.

[0026] Endoscope 104 can be inserted into an anatomical region for imaging, or (e.g., via tethering) attached to one or more sampling devices for biopsy or therapeutic devices for treating the anatomical region. Endoscope 104 can dock with or connect to control system 102. Endoscope 104 is described as a bronchoscope in this example, but other types of endoscopes for use with the features and teachings of this disclosure are contemplated. Control system 102 may include control unit 114, display unit 116, input unit 118, light source 120, fluid source 122, and suction pump 124.

[0027] The control system 102 may include various ports for coupling with the endoscope system 100. For example, the control unit 114 may include data input / output ports for receiving data from and transmitting data to the endoscope 104. The light source 120 may include an output port for transmitting light to the endoscope 104, for example, via an optical fiber link. The fluid source 122 may include a port for transmitting fluid to the endoscope 104. The fluid source 122 may include, for example, a pump and a fluid tank, or may be connected to an external tank, container, or storage unit. The suction pump 124 may include a port for evacuating the endoscope 104 to generate suction, for example, for withdrawing fluid from the anatomical region in which the endoscope 104 is inserted. The display unit 116 and the input unit 118 may be used by the operator of the endoscope system 100 to control the functions of the endoscope system 100 and to view the output of the endoscope 104. The control unit 114 may also generate signals or other outputs to process the anatomical region in which the endoscope 104 is inserted. In the example, the control unit 114 can generate electrical output, acoustic output, fluid output, etc., for use in treating the anatomical area by means of methods such as cauterization, cutting, freezing, etc.

[0028] Endoscope 104 may include an elongated member 126, a functional section 128, and a handle section 130, which may be coupled to a cable section 132 and a coupler section 134. The elongated member 126 may extend distally from the handle section 130, and the cable section 132 may extend proximally from the handle section 130. The elongated member 126 may be elongated and include a curved section and a distal end to which the functional section 128 may be attached. The curved section may be controllable (e.g., controlled by a steering control 136 on the handle section 130) to manipulate the distal end through tortuous anatomical pathways (e.g., the stomach, duodenum, kidney, ureter, trachea, lung, etc.). The elongated member 126 may also include one or more working channels (e.g., internal lumens), which may be elongated and may support the insertion of one or more therapeutic instruments, such as a bronchoscope, into the functional section 128. The working channel can extend between the handle section 130 and the functional section 128. Additional functions, such as fluid passages, guide lines, and traction lines, can also be provided by the elongated member 126 (e.g., via suction or flushing passages).

[0029] The coupler section 134 can be connected to the control unit 114 to connect the endoscope 104 to multiple features of the control unit 114, such as the input unit 118, the light source 120, the fluid source 122, and the suction pump 124.

[0030] Handle section 130 may include a steering control 136 and a port 138. Steering control 136 may be a knob, lever, or other actuation mechanism for navigating the endoscope 104 within the patient's body. Steering control 136 may be connected to a traction line or other actuation mechanism extending through the elongated member 126. Port 138, and other ports such as port 140, may be configured to couple various electrical cables, guide wires, auxiliary endoscopes, tissue collection devices, fluid tubing, etc., to handle section 130, for example, for coupling with the elongated member 126. Figure 1 and Figure 2 The example shown is an example of endoscope 104.

[0031] According to the example, the control system 102 can be mounted on a mobile platform (e.g., a trolley 142) having features for accommodating a light source 120, a suction pump 124, and an image processing unit 202. Figure 2 Shelves, etc. Alternative sites, Figure 1 and Figure 2 The components of the control system 102 shown can be directly mounted on the endoscope 104 to make the endoscope "independent".

[0032] Functional segment 128 may include components for processing and diagnosing a patient's anatomy. Functional segment 128 may include an imaging device 144 (e.g., an on-chip image sensor based on complementary metal-oxide-semiconductor (CMOS)), an illumination device 146 (e.g., a light-emitting diode), and a working channel port 112 at its distal end.

[0033] like Figure 1 As shown, medical device 108 can extend from a working channel port 112 at the distal end of the functional segment 128 of medical device 108. Medical device 108 can be configured to attach to port 138 such that medical device 108 extends through the working channel of endoscope 104 (e.g., through the elongated member 126 to the working channel port 112) and extends beyond the distal end of endoscope 104. Medical device 108 may include: an actuator 148 for advancing or retracting the elongated member 126 within the working channel to control how far the distal end of medical device 108 extends distally from the working channel port 112; an instrument actuator 150 (e.g., for actuating a biopsy needle from a side exit port of medical device 108); and a distal portion 110. Instrument actuator 150 can be configured to extend medical device 108 beyond the distal end of endoscope 104, for example, to navigate medical device 108 to a target area within a patient's body. The instrument actuator 150 can slide along the housing 152 of the medical device 108. The housing 152 may include markings that indicate the amount of extension of the medical device 108 beyond the distal end of the endoscope 104 (e.g., beyond the working channel port 112). The instrument actuator 150 may be configured to extend an instrument from the medical device 108 to obtain a tissue sample from a patient. The distal portion 110 of the medical device 108 may include a transducer (or other imaging device) and a side exit port positioned proximal to the transducer for guiding the instrument configured to obtain a tissue sample from the patient into the transducer's field of view.

[0034] Figure 2 yes Figure 1 A schematic diagram of an endoscope system 100, which includes a control system 102 and an endobronchial ultrasound device, the endobronchial ultrasound device including a medical device 108 extendable through the working channel of an endoscope 104. Figure 2Components of a control system 102 coupled to an endoscope 104 are shown. The control system 102 may include a control unit 114, which may include or be coupled to an image processing unit 202, a processing generator 204, and a drive unit 206, as well as a light source 120, an input unit 118, and a display unit 116. The control unit 114 may include, or communicate with, an endoscope, surgical instruments, and an endoscopic system. The endoscopic system may include means configured to engage tissue and collect and store a portion of that tissue, and an imaging device (e.g., a camera) may be used to observe the target tissue via means including optically enhancing materials and components. The control unit 114 may be configured to activate the camera to observe the target tissue distal to the endoscopic system. The control unit 114 may be configured to activate the light source 120 to illuminate a surgical instrument, which may include selected components configured to reflect light in a particular manner, such as a tissue cutter enhanced with reflective particles.

[0035] Coupler section 134 can be connected to control unit 114 to connect endoscope 104 to various functional components of control unit 114, such as image processing unit 202, processing generator 204, etc. In this example, port 138 can be used to insert another instrument or device, such as a sub-scope or auxiliary scope, or a sampling needle, biopsy needle, ablation instrument, scalpel, etc., into endoscope 104. Such instruments and devices can be independently connected to control unit 114 via cable section 132. In this example, port 140 can be used to connect coupler section 134 to various inputs and outputs, such as video, air, light, and electricity.

[0036] Image processing unit 202, ultrasound image processing unit 208, and light source 120 can be connected to endoscope 104 (e.g., at functional section 128) or medical device 108 via wired or wireless electrical connections. Control system 102 can generate signals to other components of endoscope system 100 to illuminate anatomical regions, collect signals representing anatomical regions, process signals representing anatomical regions, and display images representing anatomical regions on display unit 116. Ultrasound image processing unit 208 can be configured to receive ultrasound signals from either endoscope 104 or medical device 108 (or any other component of endoscope system 100), which can be converted into an ultrasound image and transmitted to display unit 116 or any other component of endoscope system 100. Control system 102 may include light source 120 for illuminating anatomical regions using light of a desired spectrum (e.g., broadband white light, narrow-band imaging using electromagnetic wavelengths, etc.). The control system 102 may be connected to the endoscope 104 (e.g., via an endoscope connector) for signal transmission (e.g., light output from a light source, video signals from an imaging system in the distal end, diagnostic and sensor signals from a diagnostic device, etc.).

[0037] Fluid source 122 ( Figure 1 The endoscope 104 (as shown) can communicate with the control unit 114 and may include one or more air sources, saline sources, or other fluid sources, as well as associated fluid paths (e.g., air passages, flushing passages, suction passages, etc.) and connectors (barbed fittings, fluid seals, valves, etc.). The control system 102 may also include a drive unit 206, which may include a motorized actuator for advancing or retracting the distal section of the endoscope 104.

[0038] Figure 3 This is a schematic diagram of an example of a distal portion 110 of an example medical device 108. The distal portion 110 of the medical device 108 may include one or more pressure sensors 310 and one or more electrodes 320 (e.g., conductive wires). Figure 3 As shown, the pressure sensor 310 may be located on the distal end of the medical device 108 or on the side of the medical device 108 and adjacent to the distal end of the medical device 108. The pressure sensor 310 may be configured to detect pressure near the distal end of the medical device 108.

[0039] Pressure sensor 310 may include microelectromechanical components that can use piezoelectric materials. For example, pressure sensor 310 may include a microelectromechanical system (MEMS) based piezoelectric sensor. Pressure sensor 310 may be attached to medical device 108 by adhesive or other fixing structures such as tapes or strips. Pressure sensor 310 may be formed directly on medical device 108 using deposition techniques. Pressure sensor 310 disposed near the distal portion 110 of medical device 108 can sense anatomical pressure around the distal end of medical device 108. Pressure sensor 310 may be disposed on the distal portion 110 of medical device 108 such that pressure sensor 310 defines the distal end of medical device 108. At least a portion of pressure sensor 310 may define the periphery of distal portion 110.

[0040] The piezoelectric material used to manufacture the pressure sensor 310 can be configured to generate a series of voltages. These voltages can be in the microvolt range. The piezoelectric material can be connected to a circuit capable of receiving voltages that can be generated in response to physical pressure. Examples of piezoelectric materials that can be used to manufacture the pressure sensor 310 include quartz, lead zirconate titanate (PZT), aluminum nitride, lithium niobate, etc.

[0041] Electrode 320 (e.g., conductive wire) may be connected to pressure sensor 310 and configured to transmit an electrical signal generated by pressure sensor 310 to one or more components of medical device 108. For example, electrode 320 may connect pressure sensor 310 to pressure signal monitoring circuitry 330. Electrode 320 may be configured to be deposited together with pressure sensor 310 on the surface of medical device 108. Electrode 320 may extend along the periphery of medical device 108. This version of electrode 320 may include masking material to control the width of electrode plating and compensate for cross-coupling capacitance. A biocompatible conformal coating may be applied to electrode 320 and pressure sensor 310 to protect pressure sensor 310, electrode 320, or pressure signal monitoring circuitry 330 from the patient's surrounding anatomy. Electrode 320 may be positioned within medical device 108 such that electrode 320 does not extend beyond the periphery of electrode 320.

[0042] although Figure 3 Multiple electrodes 320 are shown, but a single electrode 320 can be implemented. The pressure sensor 310 can operate in reference mode, in which one contact of the pressure sensor 310 can be coupled to a reference point, for example, ground reference, and the other contact can be coupled to electrode 320. The pressure sensor 310 can also operate in differential mode, in which each of the two different contacts of the pressure sensor 310 is connected to a different electrode 320.

[0043] Pressure sensor 310 may include a piezoelectric material to generate a series of electrical signals, such as voltage or current, representing a series of pressures applied to the piezoelectric material. The electrical signals may be received and processed by a connected circuit (e.g., pressure signal monitoring circuit 330). More specifically, the piezoelectric effect can cause the asymmetric crystal structure of materials such as quartz, lead zirconate titanate (PZT), aluminum nitride, lithium niobate, etc., to become slightly charged when mechanical stress is applied.

[0044] For example, when external pressure is applied to pressure sensor 310, the pressure causes the piezoelectric material to deform. This deformation of the asymmetric crystal structure generates an electric charge, which manifests as a voltage between the electrodes of pressure sensor 310. The characteristics of this voltage, such as amplitude or frequency, may be proportional to the mechanical stress applied to pressure sensor 310, or otherwise represent the amount of that mechanical stress.

[0045] The pressure signal monitoring circuit 330 can process the electrical signal from the pressure sensor 310. For example, it can capture the electrical signal, apply compensation, amplify the signal, or otherwise convert it into a pressure reading. The pressure sensor 310 can utilize microscopic crystal deformation to convert physical pressure into a measurable electrical signal. The arrangement and sensitivity of the piezoelectric material can be customized to detect pressure ranges and changes relevant to medical applications. The pressure signal monitoring circuit 330 may include an oscillator circuit for detecting changes in the signal received from the pressure sensor 310. For example, the pressure signal monitoring circuit 330 may include a Pierce crystal oscillator.

[0046] The pressure signal monitoring circuit 330 can be configured to receive and process signals from the pressure sensor 310 via the electrode 320, and, for example, amplify, capture, compensate for, or convert the signal into a pressure reading. The pressure signal monitoring circuit 330 can transmit the pressure reading to one or more systems within the endoscope system 100, such as the control unit 114. Figure 1 This can be any other system within the endoscope system 100. Pressure readings from the pressure signal monitoring circuit 330 can be transmitted to the clinician via the display unit 116 or an auditory, visual, tactile, or other display. The pressure signal monitoring circuit 330 can be located in the handle (e.g., handle section 130, see...). Figure 1 )Inside.

[0047] Figure 4 This is a block diagram of an example of an endoscope system 100. Figure 3 and Figure 4 As shown, medical device 108 (e.g., the distal portion 110 of elongated member 126, see...) Figure 1This may include one or more pressure sensors 310 and one or more electrodes 320. The pressure sensor 310 can be communicatively connected to the pressure signal monitoring circuit 330 via the electrodes 320. For example... Figure 4 As shown, the pressure signal monitoring circuit 330 can be installed in the handle section 130 ( Figure 1 The pressure signal monitoring circuit 330 can communicate with the frequency response monitor 404. In another example, the pressure signal monitoring circuit 330 can be included in the control system 102. Figure 1 )middle.

[0048] The endoscope system 100 may include a frequency response monitor 404 within the control system 102. In this example, the pressure signal monitoring circuit 330 may include the frequency response monitor 404. The frequency response monitor 404 may be connected to the pressure signal monitoring circuit 330. The frequency response monitor 404 may be configured to receive a pressure signal 406 from the pressure signal monitoring circuit 330. The pressure signal 406 may indicate the pressure detected by one or more of the pressure sensors 310.

[0049] The control system 102 may further include: a controller 408 including a processing circuitry 410; and a memory 412 including instructions 414. The memory 412 may be coupled to the controller 408. Instructions 414 may be executed by the processing circuitry 410 to receive a pressure signal 406 from a pressure signal monitoring circuit 330 via a frequency response monitor 404. Instructions 414 may be executed by the processing circuitry 410 to generate an output 416 if the pressure signal 406 exceeds a threshold 428. The threshold 428 may be stored in a database 426 communicating with the controller 408.

[0050] Output 416 may include alarm 420 and control signal 422. In an example, instruction 414 may be executed by processing circuitry 410 to cause controller 408 to signal output 416 to transmit alarm 420 to display unit 116. Controller 408 may transmit a visual representation of the combined pressure signals to output 416, which may provide this representation to display unit 116 to plot the average pressure detected along elongated member 126 and at the target site of the medical procedure. Instruction 414 may be executed by processing circuitry 410 to configure controller 408 to output control signal 422 to control components of endoscope system 100, including fluid management system 424 (e.g., a control system for fluid source 122). The control signals transmitted to fluid management system 424 form a closed-loop control system with medical device 108 for pressure management.

[0051] Figure 5 It is endoscope system 500 (e.g., endoscope system 100, see endoscope system 500). Figure 1 A block diagram of an example. Medical device 108 may include pressure sensor 502a and pressure sensor 502b (e.g., pressure sensor 310, see...). Figure 3 In this example, pressure sensor 502a may be located at or near the distal portion 110 of medical device 108. Pressure sensor 502b may be located proximally relative to pressure sensor 502a. Pressure sensor 502a may transmit signal 504a to pressure signal monitoring circuit 330 via electrode 506a. Pressure sensor 502b may transmit signal 504b to pressure signal monitoring circuit 330 via electrode 506a. Pressure sensors 502a and 502b may be coupled to medical device 108 using a thin-film deposition process. Figure 1 ).

[0052] The pressure signal monitoring circuit 330 can be configured to output signals 508a and 508b, respectively indicating signals 504a and 504b, to the frequency response monitor 404. Instruction 414 can be executed by the processing circuitry system 410 to cause the frequency response monitor 404 to receive signals 508a and 508b via the pressure signal monitoring circuit 330 and generate a combined pressure signal 418. In one example, the frequency response monitor 404 can combine signals 508a and 508b to form the combined pressure signal 418 by calculating the average value of signals 508a and 508b. Each of signals 508a and 508b can be averaged, and then the signals 508a and 508b can be combined by averaging to determine the average value of the signals. Alternatively, signals 508a and 508b can be combined by directly averaging, for example, without averaging each signal. The combined pressure signal 418 can indicate the average pressure detected in the distal portion 110 of the medical device 108. Other processing of the signal (504a, 504b, 508a or 508b) can be performed, including compensating, weighting or amplifying the signal (504a, 504b, 508a or 508b) and applying other signal processing and statistical techniques such as filtering or statistical signal combination to generate a combined pressure signal 418.

[0053] Output 416 may include alarm 420 and control signal 422. In an example, instruction 414 may be executed by processing circuitry 410 to cause controller 408 to signal output 416 to transmit alarm 420 to display unit 116. Controller 408 may transmit a visual representation of the combined pressure signals to output 416, which may provide this representation to display unit 116 to plot the average pressure detected along elongated member 126 and at the target site of the medical procedure. Instruction 414 may be executed by processing circuitry 410 to configure controller 408 to output control signal 422 to control components of endoscope system 100, including fluid management system 424 (e.g., a control system for fluid source 122). The control signals transmitted to fluid management system 424 form a closed-loop control system with medical device 108 for pressure management.

[0054] Endoscopic system 500 may include more pressure sensors (e.g., pressure sensors 502a and 502b) than endoscopic system 100, enabling endoscopic system 500 to detect pressure experienced by medical device 108 at more points. Detecting pressure at more points on medical device 108 results in a more accurate representation of pressure throughout the medical procedure. Multiple pressure sensors can be redundantly configured to provide error checking and improve measurement reliability.

[0055] Figure 6 This is a schematic diagram of an example endoscope control system, which may include a medical device 108 having a distal portion 110 and a handle portion 130. The medical device 108 may include sensors (e.g., a pressure sensor 310). Figure 3 A piezoelectric pressure sensor can be used to detect pressure. As discussed herein, pressure sensor 310 can be connected to pressure signal monitoring circuit 330 via one or more electrodes (e.g., electrode 320). Pressure sensor 310 can detect anatomical pressure and can communicate with pressure signal monitoring circuit 330. Pressure signal monitoring circuit 330 may include a Pierce crystal oscillator to output a frequency signal indicating the pressure detected by pressure sensor 310.

[0056] like Figure 6 As shown, the pressure signal monitoring circuit 330 can monitor signals from PZT material (e.g., pressure sensors 310, 502a, or 502b, in...). Figure 6 The frequency response of the pressure sensor 310 is shown in the figure. The pressure signal monitoring circuit 330 can be coupled to, for example, Figure 4 and Figure 5The frequency response monitor 404 is shown. The frequency response monitor 404 can track the frequency response of the pressure sensor 310 as the output of the pressure signal monitoring circuit 330. A shift in the frequency response, such as from 14.7 kHz to 14.9 kHz (a change of 0.2 kHz), can be detected by the frequency response monitor 404, and this shift can be used to calculate the associated pressure change. The pressure signal monitoring circuit 330 can be implemented as a differential circuit or a reference-based (e.g., ground) circuit. The frequency response monitor 404 can employ digital algorithms to determine the pressure value or pressure change based on the output of the pressure signal monitoring circuit 330, using the input from the pressure sensor 310.

[0057] Control unit 114 can be connected to frequency response monitor 404, thereby allowing the processing and interpretation of frequency data generated by frequency response monitor 404. As discussed above, control unit 114 can provide representative pressure readings to system users.

[0058] Figure 7 This is a schematic diagram of an example of the distal portion 110 of a medical device 108. The medical device 108 may include a plurality of pressure sensors 310. Pressure sensors 310 may be positioned near the distal end of the distal portion 110, proximally relative to the distal end of the distal portion 110, or positioned along the medical device 108 from the distal portion 110 toward the proximal end. Electrodes 320 may extend from the pressure sensors 310 to connect the pressure sensors 310 to a pressure signal monitoring circuit 330. The pressure signal monitoring circuit 330 may receive generated signals (e.g., signal 402). Figure 4 ) or signal 504a or signal 504b ( Figure 5 ), and to frequency response monitor 404 ( Figure 5 It provides output. Multiple pressure sensors can be redundantly configured to provide multiple measurement points, enabling error checking and improving measurement reliability.

[0059] Figure 8 This indicates the elongated member along the example (e.g., elongated member 126 of medical device 108, see...). Figure 1 A graphical representation of the pressure signals (e.g., first pressure signal 802, second pressure signal 804, third pressure signal 806, fourth pressure signal 808, and fifth pressure signal 810). As discussed herein, the system (e.g., endoscope system 100) is graphically represented. Figure 1 It may include a display unit 116. Figure 1 Instruction 414 can be used by the processing circuit system 410. Figure 4 ), to control controller 408 ( Figure 4) configured to generate a visual representation (e.g., graphic representation 800) of the combined pressure signal, for use along an elongated member (e.g., elongated member 126 of medical device 108, see Figure 1 The pressure sensor (indicated on the graphic representation 800 via pressure signals 802 to 810) can extend along the elongated member from the proximal portion to the distal portion. Therefore, the graphic representation 800 can represent the pressure along the elongated member and at the surgical site. Multiple pressure sensors can be redundantly configured to provide multiple measurement points, enabling error checking and improving measurement reliability.

[0060] Figure 9 A schematic diagram illustrating an example of a computer-based clinical decision support system (CDSS) 900 is shown, which is configured to control one or more aspects of an endoscopic system, such as endoscope system 100 or 500 (including...). Figure 1 (Medical device 108). The CDSS 900 can receive input from components of the endoscope system and provide output to components of the endoscope system. In this example, the CDSS 900 may include an input interface 904 through which information can be input. For example, patient-specific medical information (e.g., age, weight, gender) or process-specific information (e.g., location of abnormality, planned path of process, planned steps of process, etc.) may be provided to the CDSS 900 via the input interface 904. The input interface 904 may include a user interface (UI) through which a user can input information such as, for example, medical information or selection of medical information.

[0061] CDSS 900 may include an AI (artificial intelligence) model 906, which is configured to accept input, such as from an input interface 904. A processor 908 may be included in endoscope systems 100 or 500. Processor 908 may be equipped with, for example, a control unit 114. Figure 1 ) or controller 408 ( Figure 4Processor 908 can perform inference operations using AI model 906 based on one or more input sources. For example, data from any component of the endoscope system and data from external sources can be collected and input to input interface 904. External data sources may include medical information such as information about medical conditions such as injuries, abnormalities, or diseases, or process-specific information. The data input to input interface 904 can be processed by processor 908 to be applied to AI model 906 to generate output. Examples of such output include suggested medical procedures, identification of injuries, diseases, or abnormalities, and / or enhanced parameters for the operation of the endoscope system. The output can be provided to output interface 910, which may include a user interface through which the suggested medical procedures are delivered to a user, such as a clinician.

[0062] Input interface 904 may include CDSS 900 with one or more medical devices (e.g., control unit 114). Figure 1 ) or controller 408 ( Figure 4 A direct data link is established between the CDSS 900 and one or more medical devices to transmit data as input features of the CDSS 900. For example, the input interface 904 may receive input from any component of the endoscopy system, including medical information or process-specific information, such as information during treatment and / or diagnostic procedures. Alternatively or additionally, the input interface 904 may include a user interface that facilitates interaction between the user and the CDSS 900. For example, the input interface 904 may improve the user interface, allowing the user to manually input or select medical information, process-specific information, etc. Alternatively or additionally, the input interface 904 may provide the CDSS 900 with access to an electronic patient record from which one or more input features can be extracted. Such an electronic patient record may be stored in a database 902. In any of these example cases, the input interface 904 may be configured to collect one or more input features associated with a specific patient or procedure before, during, or after the time when the CDSS 900 is used for a medical procedure.

[0063] Based on one or more of the above input features, processor 908 uses AI model 906 to perform inference operations. For example, input interface 904 can pass any of the following to the input layer of AI model 906: medical information, medical procedure information, output from any component of the endoscope system, or feedback signals from the output layer of AI model 906. AI model 906 processes the input features passed to the input layer and propagates them to the output layer. AI model 906 can make inferences based on patterns discovered in data analysis. AI model 906 can use algorithms that learn from existing data and make predictions about new data (e.g., machine learning algorithms). AI model 906 can be constructed using example training data to make data-driven predictions or decisions that are represented as outputs or evaluated.

[0064] There are two common paradigms for machine learning (ML): supervised ML and unsupervised ML. Supervised ML uses prior knowledge (e.g., examples that correlate inputs with outputs or outcomes) to learn the relationship between inputs and outputs. The goal of supervised ML is to learn a function that best approximates the relationship between training inputs and outputs given some training data, so that the ML model can achieve the same relationship given an input to generate the corresponding output. Unsupervised ML trains the ML algorithm using information that is neither classified nor labeled, allowing the algorithm to operate on that information without guidance. Unsupervised ML is useful in exploratory analytics because it can automatically identify structures in the data.

[0065] Common tasks for supervised ML are classification and regression problems. Classification problems—also known as categorization problems—aim aim to classify an item into one of several class values ​​(e.g., is the object an apple or an orange?). Regression algorithms aim to quantify some items (e.g., by assigning scores to some input values). Some examples of commonly used supervised ML algorithms are logistic regression (LR), Naive Bayes, random forest (RF), neural networks (NN), deep neural networks (DNN), matrix factorization, and support vector machines (SVM).

[0066] Some common tasks in unsupervised ML include clustering, representation learning, and density estimation. Examples of commonly used unsupervised ML algorithms include K-means clustering, principal component analysis, and autoencoders.

[0067] Another type of machine learning is federated learning (also known as collaborative learning), which trains algorithms on multiple distributed devices that store local data without exchanging data. This approach contrasts with traditional centralized machine learning techniques that upload all local datasets to a single server, as well as more classic distributed methods that can assume the same distribution of local data samples. Federated learning enables multiple participants to build general, robust machine learning models without sharing data, addressing issues such as data privacy, data security, data access permissions, and access to heterogeneous data.

[0068] In the example, the AI ​​model 906 can be trained continuously or periodically by the processor 908 before performing the inference operation. During the inference operation, patient-specific input features provided to the AI ​​model 906 can propagate from the input layer, through one or more hidden layers, and ultimately to the output layer. The output layer can provide data corresponding to the identification and / or suggested medical procedures, such as lesions, diseases, or abnormalities. For example, the patient's age, body size, or any other medical information about the patient, such as the location of the sampling site, can be used as input to the CDSS 900. The CDSS 900 can use this input to indicate that samples may be difficult to obtain. In response, the processor 908 can suggest methods, such as using a smaller version of the endoscope, different paths that can improve imaging and sampling results, and / or energy levels suitable for use with cutting, ablation, or removal procedures.

[0069] Before, during, and / or after an inference operation, output interface 910 can provide suggestions that can be transmitted to the user via a user interface, and / or can provide signals or controls to any component of the endoscope system to perform a desired action. For example, an image sensor can provide an image or an indication of image quality to input interface 904. The input interface can provide an image or indication to AI model 906, which can process relevant data to provide output to output interface 910. If the output provided to output interface 910 determines or indicates poor image quality, processor 908 can transmit signals via output interface 910 to components of endoscope systems 100, 500 for compensation. For example, processor 908 can provide signals to the light source control unit to change the brightness, color, saturation, or any other parameter of light source 120. Processor 908 can send control signals to fluid source 122 to change the fluid supplied to the pump. Processor 908 can send signals to the pump to change the speed or volume of fluid supplied to the imaging site. The processor 908 can send signals to the pump to increase or decrease the suction volume supplied to the imaging site. These are exemplary actions that can be implemented by the CDSS 900 to assist in data processing and the execution of medical procedures. The CDSS 900 can assist in any aspect of the medical procedure, such as preoperative planning, intraoperative execution, or postoperative process analysis.

[0070] Figure 10This is a block diagram of an example machine 1000 on which any or more of the techniques (e.g., methods) discussed herein can be performed. As described herein, the example may include or be operable by logic or components or mechanisms in machine 1000. A circuit system (e.g., a processing circuit system) is a collection of circuits implemented in a tangible entity of machine 1000 that includes hardware (e.g., simple circuits, gates, logic, etc.). The relationships between circuit system components can be flexible over time. A circuit system includes components that can perform specific operations individually or in combination during operation. In the example, the hardware of the circuit system may be designed invariably to perform specific operations (e.g., hardwired). In the example, the hardware of the circuit system may include variable-connected physical components (e.g., execution units, transistors, simple circuits, etc.) including machine-readable media with physical modifications (e.g., magnetic ground, electric ground, movable placement of invariant mass particles, etc.) to encode instructions for specific operations. When connecting physical components, the underlying electrical characteristics of the hardware composition are altered, for example, from an insulator to a conductor or vice versa. Instructions enable embedded hardware (e.g., an execution unit or loading mechanism) to create components of a circuit system within the hardware via variable connections to perform parts of a specific operation during operation. Thus, in the example, a machine-readable medium element is part of the circuit system, or communicatively coupled to other components of the circuit system during device operation. In the example, any physical component can be used in more than one component of more than one circuit system. For example, during operation, an execution unit can be used at one point in time in a first circuit of a first circuit system and reused by a second circuit of the first circuit system, or reused at different times by a third circuit of the second circuit system. Additional examples of these components of machine 1000 are as follows.

[0071] In alternative examples, machine 1000 may operate as a standalone device or may be connected (e.g., networked) to other machines. In a networked deployment, machine 1000 may operate as a server machine, a client machine, or both in a server-client network environment. In the examples, machine 1000 may act as a peer-to-peer (P2P) (or other distributed) network environment. Machine 1000 may be a personal computer (PC), tablet PC, set-top box (STB), personal digital assistant (PDA), mobile phone, web device, network router, switch, or bridge, or any machine capable of (sequentially or otherwise) executing instructions specifying actions to be taken by that machine. Furthermore, while a single machine is shown, the term "machine" should also be considered to include any collection of machines that individually or jointly execute a set (or more) of instructions to perform any or more of the methods discussed herein, such as cloud computing, Software as a Service (SaaS), and other computer cluster configurations.

[0072] Machine 1000 may include a hardware processor 1002 (e.g., a central processing unit (CPU), graphics processing unit (GPU), hardware processor core, or any combination thereof), main memory 1004, static memory (e.g., memory or storage device for firmware, microcode, basic input / output (BIOS), and mass storage device 1008 (e.g., hard disk drive, tape drive, flash memory, or other block device), some or all of which may communicate with each other via interconnect 1030 (e.g., a bus). Machine 1000 may also include a display unit 1010, an alphanumeric input device 1012 (e.g., a keyboard), and a user interface navigation device 1014 (e.g., a mouse). In this example, the display unit 1010, the input device 1012, and the UI navigation device 1014 may be a touchscreen display. Machine 1000 may additionally include a signal generation device 1018 (e.g., a speaker), a network interface device 1020, and one or more sensors 1016, such as a global positioning system (GPS) sensor, a compass, an accelerometer, or other sensors. Machine 1000 may include output controller 1028, which may be connected serially (e.g., Universal Serial Bus (USB)), in parallel, or otherwise wired or wireless (e.g., infrared (IR), near field communication (NFC), etc.) to communicate with or control one or more peripheral devices (e.g., printers, card readers, etc.).

[0073] The registers of processor 1002, main memory 1004, static memory 1006, or mass storage device 1008 may be or include machine-readable medium 1022 on which one or more sets of data structures or instructions 1024 (e.g., software) are stored, said set of one or more sets of data structures or instructions 1024 embodying or utilizing any or more of the techniques or functions described herein. During execution of instructions 1024 by machine 1000, instructions 1024 may also reside wholly or at least partially in any of the registers of processor 1002, main memory 1004, static memory 1006, or mass storage device 1008. In this example, one or any combination of hardware processor 1002, main memory 1004, static memory 1006, or mass storage device 1008 may constitute machine-readable medium 1022. Although machine-readable medium 1022 is shown as a single medium, the term "machine-readable medium" can include a single medium or multiple media (e.g., a centralized or distributed database, and / or associated caches and servers) configured to store one or more instructions 1024.

[0074] The term "machine-readable medium" can include any medium capable of storing, encoding, or carrying instructions for execution by machine 1000 and causing machine 1000 to perform any one or more of the techniques disclosed herein, or capable of storing, encoding, or carrying data structures used by or associated with such instructions. Examples of non-limiting machine-readable media can include solid-state memory, optical media, magnetic media, and signals (e.g., radio frequency signals, other photon-based signals, sound signals, etc.). In examples, non-transitory machine-readable media includes machine-readable media having a plurality of particles with invariant (e.g., stationary) mass and thus being a composition of matter. Therefore, a non-transitory machine-readable medium is a machine-readable medium that does not include transiently propagating signals. Specific examples of non-transitory machine-readable media can include: non-volatile memory, such as semiconductor memory devices (e.g., electrically programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM)) and flash memory devices; magnetic disks, such as internal hard disks and removable disks; magneto-optical disks; and CD-ROM and DVD-ROM disks.

[0075] In the example, information stored on or otherwise provided on machine-readable medium 1022 may represent instruction 1024, such as instruction 1024 itself or a format from which instruction 1024 can be derived. Such a format from which instruction 1024 can be derived may include source code, encoded instructions (e.g., in compressed or encrypted form), packaged instructions (e.g., split into multiple packages), etc. Information representing instruction 1024 in machine-readable medium 1022 may be processed by a processing circuitry system into instructions to perform any of the operations discussed herein. For example, deriving instruction 1024 from information (e.g., processed by a processing circuitry system) may include: (e.g., from source code, object code, etc.) compiling, interpreting, loading, organizing (e.g., dynamic or static linking), encoding, decoding, encrypting, decrypting, packaging, unpacking, or otherwise processing the information into instruction 1024.

[0076] In the example, the derivation of instruction 1024 may include the assembly, compilation, or interpretation of information (e.g., by processing a circuit system) to create instruction 1024 according to some intermediate or preprocessed format provided by machine-readable medium 1022. Information provided in multiple parts may be combined, unpacked, and modified to create instruction 1024. For example, the information may be in multiple compressed source code packages (or object code, or binary executable code, etc.) on one or more remote servers. The source code packages may be encrypted during transmission over a network and may be decrypted, decompressed, assembled (e.g., linked), and compiled or interpreted at the local machine (e.g., compiled or interpreted into libraries, standalone executables, etc.) and executed by the local machine.

[0077] Commands 1024 can also be transmitted or received via the communication network 1026 using a transmission medium via the network interface device 1020, utilizing any of several transport protocols (e.g., Frame Relay, Internet Protocol (IP), Transmission Control Protocol (TCP), User Datagram Protocol (UDP), Hypertext Transfer Protocol (HTTP), etc.). Example communication networks may include local area networks (LANs), wide area networks (WANs), packet data networks (e.g., the Internet), LoRa / LoRaWAN or satellite communication networks, mobile phone networks (e.g., cellular networks, such as cellular networks compliant with 3G, 4G LTE / LTE-A, or 5G standards), conventional telephone (POTS) networks, and wireless data networks (e.g., IEEE 802.11 family of standards known as Wi-Fi®, IEEE 802.15.4 family of standards, peer-to-peer (P2P) networks, etc.). In the example, the network interface device 1020 may include one or more physical jacks (e.g., Ethernet, coaxial, or telephone jacks) or one or more antennas for connection to the communication network 1026. In the example, network interface device 1020 may include multiple antennas for wireless communication using at least one of single-input multiple-output (SIMO), multiple-input multiple-output (MIMO), or multiple-input single-output (MISO) technologies. The term "transmission medium" should be considered to include any intangible medium capable of storing, encoding, or carrying instructions executable by machine 1000, and includes digital or analog communication signals or other intangible media to facilitate communication of such software. The transmission medium is a machine-readable medium.

[0078] Figure 11 This is a block diagram illustrating example method 1100. Method 1100 can be used to form an example endoscope. Method 1100 can be used to form any endoscope discussed herein (e.g., Figure 1 (The medical device 108 shown first). Method 1100 may include one or more of operations 1110 to 1130.

[0079] At operation 1110, method 1100 may include placing a first pressure sensor (e.g., pressure sensor 310) Figure 3 Coupled to an elongated member (e.g., elongated member 126). Figure 1 The distal portion of (e.g., distal portion 110) Figure 1 )).like Figure 1As discussed herein, the elongated member 126 may include a lumen extending from a distal portion (e.g., distal portion 110) to a proximal portion. The first pressure sensor 310 may be configured to detect pressure at a target site. For example, the pressure sensor 310 may be configured to detect pressure at, adjacent to, or around the distal portion 110 of the medical device 108.

[0080] At operation 1120, method 1100 may include a second pressure sensor (e.g., pressure sensor 310). Figure 3 A second pressure sensor is coupled proximally to the elongated member 126 relative to the first pressure sensor. The second pressure sensor may be mounted adjacent to the first pressure sensor and extends proximally along the elongated member 126. The second pressure sensor may be spaced proximally from the first pressure sensor and coupled to the elongated member 126. In this example, the medical device 108 may include a plurality of pressure sensors extending along 126 from the distal portion 110 of the elongated member 126 to its proximal end.

[0081] At operation 1130, method 1100 may include connecting a first pressure sensor and a second pressure sensor to a pressure signal monitoring circuit (e.g., pressure signal monitoring circuit 330) using electrodes (e.g., electrode 320). Figure 3 )).like Figure 3 As shown, two electrodes 320 of the electrodes 320 may extend between the first pressure sensor and the second pressure sensor. In the example, a single electrode may extend between the first pressure sensor and the second pressure sensor, or more than two (e.g., three, four, five, six or more) electrodes may extend between the pressure sensor and the pressure signal monitoring circuit 330.

[0082] The following non-limiting examples detail some implementations of this topic that address the challenges and provide the benefits discussed herein.

[0083] Example 1 is an endoscope system comprising: a processor configured to process data relating to components of the endoscope system; and an endoscope comprising: an elongated member including a lumen extending from a proximal portion of the elongated member to a distal portion of the elongated member; and a pressure sensor coupled to the distal portion of the elongated member.

[0084] In Example 2, the subject matter of Example 1 may optionally include an endoscope system comprising: a second pressure sensor coupled to an elongated member, the second pressure sensor being configured to detect pressure along the elongated member.

[0085] In Example 3, the subject matter of Example 2 may optionally include an endoscope system comprising: a pressure signal monitoring circuit; and an electrode that connects a pressure sensor and a second pressure sensor to the pressure signal monitoring circuit.

[0086] In Example 4, the subject matter of Example 3 may optionally include, wherein the processor includes: a frequency response monitor connected to a pressure signal monitoring circuit and configured to receive a pressure signal from the pressure signal monitoring circuit, the pressure signal indicating pressure detected by at least one of a pressure sensor or a second pressure sensor.

[0087] In Example 5, the subject matter of Example 4 may optionally include, wherein the processor includes: a memory that includes instructions that, when processed by the processor, perform the following steps: receiving a pressure signal from a pressure signal monitoring circuit using a frequency response monitor; and generating an alarm based on the pressure signal exceeding a pressure threshold.

[0088] In Example 6, the subject matter of Example 5 may optionally include a second pressure sensor coupled at a proximal end to a distal portion of an elongated member relative to a pressure sensor, and wherein a pressure signal monitoring circuit is configured to output a first pressure signal and a second pressure signal.

[0089] In Example 7, the subject matter of Example 6 may optionally include, wherein the instructions are configured to be processed by a processor to perform the following steps: receiving a first pressure signal and a second pressure signal using a frequency response monitor; generating a combined pressure signal by averaging the first pressure signal and the second pressure signal, the combined pressure signal indicating the average pressure detected in the distal portion of the elongated member; and generating an alarm based on the combined pressure signal relative to an average pressure threshold.

[0090] In Example 8, the subject matter of any one or more of Examples 6 to 7 may optionally include, wherein the instructions are configured to be processed by a processor to implement the following steps: receiving a first pressure signal and a second pressure signal using a frequency response monitor; generating a combined pressure signal by averaging the first pressure signal and the second pressure signal, the combined pressure signal indicating the average pressure detected in the distal portion of the elongated member; and transmitting a control signal to at least one component of the endoscope based on the combined pressure signal to realize a closed-loop control system for pressure management.

[0091] In Example 9, the subject matter of Example 8 may optionally include a closed-loop control system comprising a fluid management subsystem for regulating fluid pressure at the surgical site based on a combined pressure signal.

[0092] In Example 10, the subject matter of any one or more of Examples 8 to 9 may optionally include, wherein the endoscope system includes a user interface, and wherein instructions are configured to be processed by a processor to perform the following steps: generating a visual representation of combined pressure signals to plot the average pressure detected along an elongated member or at a target site.

[0093] In Example 11, the subject matter of any one or more of Examples 1 to 10 may optionally include, wherein the elongated member includes a plurality of pressure sensors distributed along the length of the elongated member to enable measurement of the pressure gradient along the length.

[0094] In Example 12, the subject matter of Example 11 may optionally include the plurality of pressure sensors being configured to operate in a redundant configuration to provide error checking and improve measurement reliability.

[0095] Example 13 is an endoscope comprising: an elongated member including a lumen extending from a proximal portion of the elongated member to a distal portion of the elongated member; and a pressure sensor coupled to the distal portion of the elongated member.

[0096] In Example 14, the subject matter of Example 13 may optionally include an endoscope comprising: a second pressure sensor coupled to an elongated member, the second pressure sensor being configured to detect pressure along the elongated member.

[0097] In Example 15, the subject matter of Example 14 may optionally include a pressure sensor disposed at the distal end of the elongated member, and a second pressure sensor disposed at the proximal end of the elongated member on the exterior of the distal portion of the elongated member relative to the pressure sensor.

[0098] In Example 16, the subject matter of any one or more of Examples 14 to 15 may optionally include, wherein the endoscope includes electrodes that connect a pressure sensor and a second pressure sensor to a pressure signal monitoring circuit.

[0099] In Example 17, the subject matter of Example 16 may optionally include, wherein at least one of the pressure sensor or the second pressure sensor includes a microelectromechanical system (MEMS) based piezoelectric sensor.

[0100] In Example 18, the subject matter of Example 17 may optionally include a MEMS-based piezoelectric sensor formed on the outer surface of the distal portion of an elongated member using a thin-film deposition process, and wherein an electrode defines at least a portion of the periphery of the elongated member.

[0101] Example 19 is a method of forming an endoscope, comprising: coupling a first pressure sensor to a distal portion of an elongated member including a lumen extending from the distal portion to a proximal portion, the first pressure sensor being configured to detect pressure at a target site; coupling a second pressure sensor to the elongated member proximal to the first pressure sensor; and connecting the first and second pressure sensors to a pressure signal monitoring circuit using electrodes.

[0102] In Example 20, the subject matter of Example 19 may optionally include connecting a pressure signal monitoring circuit to a processor to provide a pressure signal from at least one of a first pressure sensor or a second pressure sensor, the pressure signal indicating the pressure detected by the respective pressure sensor.

[0103] Example 21 is an endoscope system including: a processor configured to process data relating to components of the endoscope system; and an endoscope including: an elongated member including a lumen extending from a proximal portion of the elongated member to a distal portion of the elongated member; and a pressure sensor coupled to the distal portion of the elongated member.

[0104] In Example 22, the subject matter of Example 21 may optionally include an endoscope system comprising: a second pressure sensor coupled to an elongated member, the second pressure sensor being configured to detect pressure along the elongated member.

[0105] In Example 23, the subject matter of Example 22 may optionally include an endoscope system comprising: a pressure signal monitoring circuit; and an electrode that connects a pressure sensor and a second pressure sensor to the pressure signal monitoring circuit.

[0106] In Example 24, the subject matter of Example 23 may optionally include, wherein the processor includes: a frequency response monitor connected to a pressure signal monitoring circuit and configured to receive a pressure signal from the pressure signal monitoring circuit, the pressure signal indicating pressure detected by at least one of a pressure sensor or a second pressure sensor.

[0107] In Example 25, the subject matter of Example 24 may optionally include, wherein the processor includes: a memory that includes instructions that, when processed by the processor, perform the following steps: receiving a pressure signal from a pressure signal monitoring circuit using a frequency response monitor; and generating an alarm based on the pressure signal exceeding a pressure threshold.

[0108] In Example 26, the subject matter of Example 25 may optionally include a second pressure sensor coupled at a proximal end to a distal portion of an elongated member relative to a pressure sensor, and wherein a pressure signal monitoring circuit is configured to output a first pressure signal and a second pressure signal.

[0109] In Example 27, the subject matter of Example 26 may optionally include instructions configured to be processed by a processor to perform the following steps: receiving a first pressure signal and a second pressure signal using a frequency response monitor; generating a combined pressure signal by averaging the first pressure signal and the second pressure signal, the combined pressure signal indicating the average pressure detected in the distal portion of the elongated member; and generating an alarm based on the combined pressure signal relative to an average pressure threshold.

[0110] In Example 28, the subject matter of any one or more of Examples 26 to 27 may optionally include, wherein instructions are configured to be processed by a processor to perform the following steps: receiving a first pressure signal and a second pressure signal using a frequency response monitor; generating a combined pressure signal by averaging the first pressure signal and the second pressure signal, the combined pressure signal indicating the average pressure detected in the distal portion of the elongated member; and transmitting a control signal to at least one component of the endoscope based on the combined pressure signal to implement a closed-loop control system for pressure management.

[0111] In Example 29, the subject matter of Example 28 may optionally include, wherein the closed-loop control system includes a fluid management subsystem for regulating fluid pressure at the surgical site based on a combined pressure signal.

[0112] In Example 30, the subject matter of any one or more of Examples 28 to 29 may optionally include, wherein the endoscope system includes a user interface, and wherein instructions are configured to be processed by a processor to perform the following steps: generating a visual representation of combined pressure signals to plot the average pressure detected along an elongated member or at a target site.

[0113] In Example 31, the subject matter of any one or more of Examples 21 to 30 may optionally include, wherein the elongated member includes a plurality of pressure sensors distributed along the length of the elongated member to enable measurement of the pressure gradient along the length.

[0114] In Example 32, the subject matter of Example 31 may optionally include the plurality of pressure sensors being configured to operate in a redundant configuration to provide error checking and improve measurement reliability.

[0115] Example 33 is an endoscope comprising: an elongated member including a lumen extending from a proximal portion of the elongated member to a distal portion of the elongated member; and a pressure sensor coupled to the distal portion of the elongated member.

[0116] In Example 34, the subject matter of Example 33 may optionally include, wherein the endoscope includes: a second pressure sensor coupled to an elongated member, the second pressure sensor being configured to detect pressure along the elongated member.

[0117] In Example 35, the subject matter of Example 34 may optionally include a pressure sensor disposed at the distal end of the elongated member, and a second pressure sensor disposed at the proximal end of the elongated member on the exterior of the distal portion of the elongated member relative to the pressure sensor.

[0118] In Example 36, the subject matter of any one or more of Examples 34 to 35 may optionally include, wherein the endoscope includes electrodes that connect a pressure sensor and a second pressure sensor to a pressure signal monitoring circuit.

[0119] In Example 37, the subject matter of Example 36 may optionally include, wherein at least one of the pressure sensor or the second pressure sensor includes a microelectromechanical system (MEMS) based piezoelectric sensor.

[0120] In Example 38, the subject matter of Example 37 may optionally include a MEMS-based piezoelectric sensor formed on the outer surface of the distal portion of an elongated member using a thin-film deposition process, and wherein an electrode defines at least a portion of the periphery of the elongated member.

[0121] Example 39 is a method of forming an endoscope, comprising: coupling a first pressure sensor to a distal portion of an elongated member including a lumen extending from the distal portion to a proximal portion, the first pressure sensor being configured to detect pressure at a target site; coupling a second pressure sensor to the elongated member proximal to the first pressure sensor; and connecting the first and second pressure sensors to a pressure signal monitoring circuit using electrodes.

[0122] In Example 40, the subject matter of Example 39 may optionally include connecting a pressure signal monitoring circuit to a processor to provide a pressure signal from at least one of a first pressure sensor or a second pressure sensor, the pressure signal indicating the pressure detected by the respective pressure sensor.

[0123] Example 41 may include methods, systems, devices, and endoscopes that include any of the elements of Examples 1 to 40.

[0124] The above detailed description includes reference to the accompanying drawings, which form part of the detailed description. The drawings illustrate specific examples that can be practiced by way of illustration. These embodiments are also referred to herein as "examples". Such examples may include elements other than those shown or described. This disclosure includes examples that provide those elements shown or described. Furthermore, this disclosure includes examples of any combination or arrangement of those elements shown or described herein with respect to a particular example (or one or more implementations thereof) or with respect to other examples (or one or more implementations thereof).

[0125] All publications, patents, and patent documents mentioned in this document are incorporated herein by reference in their entirety, as if they were individually incorporated by reference. In the event of any inconsistency between the usage in this document and those documents incorporated by reference, the usage in the incorporated reference shall be considered supplementary to the usage in this document, and in the case of irreconcilable inconsistencies, the usage in this document shall prevail.

[0126] In this document, as is common in patent documents, the terms “a” or “an” are used to include one or more, regardless of any other instance or usage of “at least one” or “one or more”. In this document, unless otherwise indicated, the term “or” is used to refer to a non-exclusive “or”, such that “A or B” includes “A but not B”, “B but not A”, and “A and B”. In the appended claims, the terms “including” and “inwhich” are used as concise English equivalents to the corresponding terms “comprising” and “wherein”. Furthermore, in the appended claims, the terms “including” and “comprising” are open-ended, meaning that a system, apparatus, article, or process that includes elements other than those listed in the claims following such terms is still considered to fall within the scope of the claims. Additionally, in the appended claims, the terms “first,” “second,” and “third,” etc., are used merely as designations and are not intended to impose numerical requirements on their objects.

[0127] When the term “approximately” is used in conjunction with a numerical range, it modifies the range by extending the stated value above and below the boundary. Typically, the term “approximately” is used herein to modify a numerical value by varying by 10% above or below the stated value. For example, the term “approximately” means plus or minus 10% of the numerical value of the number to which the term is used. Thus, approximately 50% means a range of 45% to 55%. Numerical ranges listed by endpoints herein include all digits and fractions contained within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.90, 4, 4.24, and 5). Similarly, numerical ranges listed by endpoints herein include subranges contained within that range (e.g., 1 to 5 includes 1 to 1.5, 1.5 to 2, 2 to 2.75, 2.75 to 3, 3 to 3.90, 3.90 to 4, 4 to 4.24, 4.24 to 5, 2 to 5, 3 to 5, 1 to 4, and 2 to 4). It is also understandable that all numbers and their fractions are assumed to be modified by the term "about".

[0128] The above description is intended to be illustrative and not restrictive. For example, the examples above (or one or more implementations thereof) can be used in combination with each other. Other examples may be used by one of ordinary skill in the art upon review of the above description. The abstract is provided to enable the reader to quickly determine the nature of the technical disclosure and to understand that it will not be used to interpret or limit the scope or meaning of the claims. Furthermore, in the detailed description above, various features may be grouped together to simplify the disclosure. This grouping should not be construed as implying that any unclaimed disclosed feature is necessary for any claim. Rather, the subject matter of the invention may lie in fewer than all features of a particular disclosed embodiment. Therefore, the appended claims are incorporated herein by reference to the detailed description, wherein each claim exists independently as a separate embodiment. The scope of the examples should be determined by reference to the full scope of the appended claims together with their equivalents.

[0129] The device disclosed herein can be designed for single-use post-treatment or for multiple uses. However, in either case, the device can be repaired for reuse after at least one use. Repair may include a combination of the following steps: disassembly of the device, subsequent cleaning or replacement of specific parts, and subsequent reassembly. In particular, the device can be disassembled, and any number of specific parts or components of the device can be selectively replaced or removed in any combination. After cleaning and / or replacement of specific parts, the device can be reassembled at a repair facility or by a surgical team immediately before the surgical procedure for subsequent use. Those skilled in the art will understand that the repair of the device can utilize a variety of different techniques for disassembly, cleaning / replacement, and reassembly. The use of such techniques and the resulting repaired devices are within the scope of this application.

[0130] Preferably, the device described herein is processed prior to surgery. Processing may include obtaining a new or used instrument and determining whether the instrument should be cleaned, and based on that determination, performing a cleaning process. The instrument may be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic bag or a TYVEK® bag. The container and instrument are placed in a radiation field, such as gamma radiation, X-rays, or high-energy electrons, that can penetrate the container. The radiation kills bacteria on the instrument and in the container. The sterile instrument can then be stored in a sterile container. The sealed container keeps the instrument sterile. Any other techniques known in the art may also be used to sterilize the instrument, including but not limited to beta or gamma radiation, ethylene oxide, or vapor.

Claims

1. An endoscope system, comprising: A processor configured to process data related to components of the endoscope system; as well as An endoscope, the endoscope comprising: An elongated member, the elongated member including a lumen extending from a proximal portion of the elongated member to a distal portion of the elongated member; as well as A pressure sensor coupled to the distal portion of the elongated member.

2. The endoscope system according to claim 1, wherein, The endoscope system includes: A second pressure sensor is coupled to the elongated member, the second pressure sensor being configured to detect pressure along the elongated member.

3. The endoscope system according to claim 2, wherein, The endoscope system includes: Pressure signal monitoring circuit; and An electrode is provided that connects the pressure sensor and the second pressure sensor to the pressure signal monitoring circuit.

4. The endoscope system according to claim 3, wherein, The processor includes: A frequency response monitor is connected to the pressure signal monitoring circuit and configured to receive a pressure signal from the pressure signal monitoring circuit, the pressure signal indicating the pressure detected by at least one of the pressure sensor or the second pressure sensor.

5. The endoscopic system according to claim 4, wherein, The processor includes: The memory includes instructions that, when processed by the processor, perform the following steps: The frequency response monitor receives the pressure signal from the pressure signal monitoring circuit; and An alarm is generated based on the pressure signal exceeding the pressure threshold.

6. The endoscopic system according to claim 5, wherein, The second pressure sensor is coupled to the distal portion of the elongated member at its proximal end relative to the pressure sensor, and wherein the pressure signal monitoring circuit is configured to output a first pressure signal and a second pressure signal.

7. The endoscope system according to claim 6, wherein, The instructions are configured to be processed by the processor to perform the following steps: The frequency response monitor is used to receive the first pressure signal and the second pressure signal; A combined pressure signal is generated by averaging the first pressure signal and the second pressure signal, the combined pressure signal indicating the average pressure detected in the distal portion of the elongated member; and An alarm is generated based on the combined pressure signal relative to the average pressure threshold.

8. The endoscope system according to claim 6, wherein, The instructions are configured to be processed by the processor to perform the following steps: The frequency response monitor is used to receive the first pressure signal and the second pressure signal; A combined pressure signal is generated by averaging the first pressure signal and the second pressure signal, the combined pressure signal indicating the average pressure detected in the distal portion of the elongated member; and Based on the combined pressure signal, control signals are transmitted to at least one component of the endoscope to realize a closed-loop control system for pressure management.

9. The endoscope system according to claim 8, wherein, The closed-loop control system includes a fluid management subsystem, which is used to adjust the fluid pressure at the surgical site based on the combined pressure signal.

10. The endoscope system according to claim 8, wherein, The endoscope system includes a user interface, and wherein the instructions are configured to be processed by the processor to perform the following steps: A visual representation of the combined pressure signal is generated to plot the average pressure detected along the elongated member or at the target location.

11. The endoscope according to claim 1, wherein, The elongated member includes a plurality of pressure sensors distributed along the length of the elongated member to enable measurement of the pressure gradient along the length.

12. The endoscope according to claim 11, wherein, The multiple pressure sensors are configured to operate in a redundant configuration to provide error checking and improve measurement reliability.

13. An endoscope comprising: An elongated member, the elongated member including a lumen extending from a proximal portion of the elongated member to a distal portion of the elongated member; as well as A pressure sensor coupled to the distal portion of the elongated member.

14. The endoscope according to claim 13, wherein, The endoscope includes a second pressure sensor coupled to the elongated member, the second pressure sensor being configured to detect pressure along the elongated member.

15. The endoscope according to claim 14, wherein, The pressure sensor is disposed at the distal end of the elongated member, and wherein the second pressure sensor is disposed at the proximal end of the distal portion of the elongated member relative to the pressure sensor.

16. The endoscope according to claim 14, wherein, The endoscope includes electrodes that connect the pressure sensor and the second pressure sensor to a pressure signal monitoring circuit.

17. The endoscope according to claim 16, wherein, At least one of the pressure sensor or the second pressure sensor includes a piezoelectric sensor based on microelectromechanical systems (MEMS).

18. The endoscope according to claim 17, wherein, The MEMS-based piezoelectric sensor is formed on the outer surface of the distal portion of the elongated member using a thin-film deposition process, wherein the electrode defines at least a portion of the periphery of the elongated member.

19. A method of forming an endoscope, comprising: A first pressure sensor is coupled to a distal portion of an elongated member, the elongated member including a lumen extending from the distal portion to a proximal portion, the first pressure sensor being configured to detect pressure at a target location; The second pressure sensor is coupled to the elongated member at its proximal end relative to the first pressure sensor; as well as The first pressure sensor and the second pressure sensor are connected to the pressure signal monitoring circuit using electrodes.

20. The method of claim 19, comprising: The pressure signal monitoring circuit is connected to the processor to provide a pressure signal from at least one of the first pressure sensor or the second pressure sensor, the pressure signal indicating the pressure detected by the respective pressure sensor.

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