Pressure relief features for medical device
The fluid management system for endoscopes addresses fluid accumulation and pressure issues by using tubing, bypass lines, and pressure-regulating reservoirs to ensure efficient and safe operation during medical procedures.
Patent Information
- Application Number
- PCT/US2025/040480
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-08-13
- Filing Date
- 2025-08-04
- Publication Date
- 2026-02-19
AI Technical Summary
Endoscopes face challenges with fluid accumulation and pressure buildup in working channels due to small diameters, leading to reduced efficiency and potential complications during medical procedures.
A fluid management system with inflow and outflow tubing, a bypass line, and a pressure-regulating reservoir to manage fluid flow and pressure within the endoscope, including valves and suction pumps to mitigate blockages and pressure buildup.
The system effectively reduces pressure and prevents blockages, maintaining endoscope functionality and safety during medical procedures by redirecting fluid flow and regulating pressure.
Smart Images

Figure US2025040480_19022026_PF_FP_ABST
Abstract
Description
Docket No. 5409.906W01 / / GAP24043-SUSF-WO 1PRESSURE RELIEF FEATURES FOR MEDICAL DEVICEPRIORITY CLAIM
[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 682,585, filed August 13, 2024, the contents of which are incorporated herein by reference.TECHNICAL FIELD
[0002] Examples described herein generally relate to an endoscope, specifically an endoscope with a fluid management system.BACKGROUND
[0003] The field of medical endoscopy has seen significant advancements over the years, leading to the development of various devices and systems that assist clinicians in diagnostic and therapeutic procedures. Endoscopes can be inserted into the body to observe or perform medical procedures in the interior of a hollow organ or cavity. During medical procedures, maintaining clear visibility and functionality of the endoscope aids the medical professional in the navigation and operation of the endoscope.
[0004] One of the challenges encountered during endoscopic procedures is the accumulation of outflow fluid (e.g., inflow fluid, patient fluid, surgical debris, tissues, or the like) within the working channels of the endoscope, such as the suction channel. This outflow fluid can include tissue fragments, blood, and other matter that can obstruct the channels, leading to reduced efficiency in outflow fluid removal and potential complications during the procedure. The small diameters of the working channels in endoscopes make them particularly susceptible to such blockages, which can cause pressure buildup within the endoscope. Pressure buildup can also be caused by other symptoms, such as a kink or other blockage of the tubing.SUMMARY
[0005] In examples, a fluid management system for an endoscope can include an inflow tubing configured to direct a fluid toward a surgical site. An outflow tubing can be configured to draw outflow fluid away from the surgical site. The fluid management system can also include a bypass line fluidically connecting the inflowDocket No. 5409.906W01 / / GAP24043-SUSF-WO 1 tubing and the outflow tubing to direct the fluid from the inflow tubing to the outflow tubing and bypass the surgical site. A valve can be operable to permit fluid flow from the inflow tubing to the outflow tubing on condition that a pressure in one or more of the inflow tubing, the outflow tubing, or the surgical site.
[0006] In examples, a fluid management system for an endoscope can include an outflow tubing configured to direct outflow fluid away from a surgical site. The fluid management system can also include a suction pump fluidically connected to the outflow tubing and configured to draw the outflow fluid away from the surgical site. A pressure-regulating reservoir can be fluidically connected to the outflow tubing. The pressure-regulating reservoir can be configured to expand in response to a pressure within the outflow tubing being above a threshold value.BRIEF DESCRIPTION OF THE DRAWINGS
[0007] Various examples are illustrated in the figures of the accompanying drawings. Such examples are demonstrative and not intended to be exhaustive or exclusive examples of the present subject matter.
[0008] FIG. 1 illustrates an example diagram of an example endoscope including an example system for fluid management.
[0009] FIG. 2 illustrates an example diagram of a portion of an example endoscope including an example valve in an example bypass line.
[0010] FIG. 3 illustrates an example diagram of a portion of an example endoscope including an example valve in an example bypass line.
[0011] FIG. 4 illustrates an example diagram of a portion of an example endoscope, including an example valve in an example bypass line.
[0012] FIG. 5 illustrates an example diagram of a portion of an example endoscope including an example valve in an example bypass line.
[0013] FIG. 6 illustrates an example diagram of a portion of an example endoscope including an example valve in an example bypass line.
[0014] FIG. 7 illustrates an example diagram of a portion of an example endoscope including an example valve in an example bypass line.
[0015] FIG. 8 illustrates an example diagram of an example valve.
[0016] FIG. 9 illustrates an example diagram of an example valve.Docket No. 5409.906W01 / / GAP24043-SUSF-WO 1
[0017] FIG. 10 illustrates an example diagram of an example endoscope including an example pressure-regulating reservoir.
[0018] FIG. 11 illustrates an example diagram of an example endoscope including an example pressure-regulating reservoir in an expanded configuration.
[0019] FIG. 12 illustrates an example diagram of an example endoscope including an example pressure-regulating reservoir including an example valve.
[0020] FIG. 13 illustrates an example diagram of an example endoscope including an example pressure-regulating reservoir including an example pressure relief valve.
[0021] FIG. 14 illustrates an example diagram of an example endoscope including an example pressure-regulating reservoir including an example valve and a pressure relief valve.
[0022] FIG. 15 illustrates an example diagram of an example endoscope including multiple example pressure-regulating reservoirs.
[0023] FIG. 16 is a schematic diagram of an example of a computer-based clinical decision support system (CDSS).
[0024] FIG. 17 is a block diagram illustrating an example of a machine upon which one or more examples can be implemented.DETAILED DESCRIPTION
[0025] An endoscope can include a tubular portion (elongated member) insertable into an interior of an organ or a cavity (or lumen) of the body to assist in diagnosis or treatment. One or more working channels (e.g., a suction channel or an irrigation channel) can be disposed inside and extend along a length of the tubular portion. To lower the risk of unintentionally engaging with unintended tissue, the insertable tubular portion can include a smaller diameter than the rest of the endoscope. Consequently, the working channels can also include small lumen diameters.Therefore, because of the small diameters of the working channels, outflow fluid and foreign objects (e.g., calculi and fragments thereof) can accumulate and clog the working channel.
[0026] A fluid management system can be connected to the endoscope to provide irrigation fluid (e.g., saline) and suction. The fluid management system can include inflow tubing and outflow tubing fluidically connected to the irrigation channelDocket No. 5409.906W01 / / GAP24043-SUSF-WO 1 and the suction channel of the endoscope, respectively. Like the working channels, the inflow and outflow tubing can become clogged, kinked, or blocked.
[0027] In this document, “clog” refers to outflow fluid, calculi (e.g., kidney stones or stone fragments), and other matter that can accumulate and block the lumen of a channel wholly or partially, “clogging” refers to a state of partial or complete blockage of the channel lumen, “kink” refers to tubing bending, warping, or becoming deformed such as to interfere with fluid or outflow fluid flow therethrough.
[0028] Clogging in a shaft, the suction channel, or the outflow tubing can significantly reduce the efficiency of removing outflow fluid and stone fragments. Delayed or inefficient removal of unwanted matters from the anatomical site can inhibit or prevent further treatment (e.g., debridement or ablation of stones), contaminate the anatomical site, or expose the patient to an increased risk.
[0029] The present disclosure includes solutions to address one or more of the above-stated problems by reducing pressures within the tubing and at the surgical site.
[0030] A fluid management system for an endoscope can include an inflow tubing configured to direct a fluid toward a surgical site. An outflow tubing can be configured to draw outflow fluid away from the surgical site. The fluid management system can also include a bypass line fluidically connecting the inflow tubing and the outflow tubing to direct the fluid from the inflow tubing to the outflow tubing and bypass the surgical site. A valve can be operable to permit fluid flow from the inflow tubing to the outflow tubing based on a pressure in one or more of the inflow tubing, the outflow tubing, or the surgical site.
[0031] In examples, a fluid management system for an endoscope can include an outflow tubing configured to direct outflow fluid away from a surgical site. The fluid management system can also include a suction pump fluidically connected to the outflow tubing and configured to draw the outflow fluid away from the surgical site. A pressure-regulating reservoir can be fluidically connected to the outflow tubing. The pressure-regulating reservoir can be configured to expand in response to a pressure within the outflow tubing being above a threshold value.
[0032] The above discussion is intended to provide an overview of the subject matter of the present disclosure. It is not intended to provide an exclusive or exhaustive explanation of the disclosure. The description below provides further information about the present patent application.Docket No. 5409.906W01 / / GAP24043-SUSF-WO 1
[0033] FIG. 1 illustrates an example diagram of an example endoscopic system 100. The endoscopic system 100 can be a lithotripter configured to remove outflow fluid from within a kidney of a patient, an ablation device to remove outflow fluid from within a patient, a ureteroscope configured to work within a urinary tract of a patient, any other medical instrument configured to be inserted within the patient, or the like. The endoscopic system 100 can include a console 102, an endoscope 104, a handle 106, an irrigation fluid port 108, a suction port 110, a shaft 112, an irrigation fluid source 114, an irrigation line 116, an inflow pump 118, a suction source 120, a suction line 122, a purging device 124, a debris collector 126, a user interface 128, a control module 130, a pressure monitor 132, and a power source 134.
[0034] The console 102 can include control circuitry (e.g., the control module 130, the pressure monitor 132, or the like) for controlling the operation of the endoscopic system 100 during a medical procedure. The console 102 can be fluidically connected to the irrigation fluid source 114, the inflow pump 118, the suction source 120, and the debris collector 126. The console 102 can also communicate with the user interface 128. For example, the user interface can be included in the console 102, or any other component of the endoscopic system 100.
[0035] The endoscope 104 can be in communication with the console 102 such that the console 102 can control the operation of the endoscope 104. The endoscope 104 can include the handle 106 and the shaft 112. The handle 106 can be configured to be held by the clinician to control the endoscope 104 during the medical procedure. The handle 106 can be generally elongated such as to improve the ergonomics of the clinician during the use of the endoscope 104.
[0036] The handle 106 can include the irrigation fluid port 108 and the suction port 110. The irrigation fluid port 108 can fluidically connect the irrigation fluid source 114 to the shaft 112 to provide irrigation fluid (e.g., water, saline, other biocompatible liquids, or the like) from the irrigation fluid source 114 and to the procedure site (e.g., the distal end of the shaft 112). The inflow pump 118 can be configured to provide the irrigation fluid source 114 to the distal end of the shaft 112 via the irrigation line 116 and the irrigation fluid port 108. The suction port 110 can fluidically connect the shaft 112 to the debris collector 126 via the suction line 122 to draw outflow fluid, fluid, excess irrigation fluid, or the like away from the distal end of the shaft 112. The suction source 120 can provide suction to the endoscopic system 100 such as to draw outflow fluid (e.g., kidney stone fragments, ablated tissue, blood, excess irrigationDocket No. 5409.906W01 / / GAP24043-SUSF-WO 1 fluid, or the like) away from the distal end of the shaft 112 and toward the debris collector 126 via the suction port 110 and the suction line 122. The suction source 120 can be a pump configured to draw the outflow fluid away from the distal end of the shaft 112. The debris collector 126 can be configured to measure collected debris during the medical procedure.
[0037] The shaft 112 can extend from the handle 106 and be fluidically connected to the handle 106. The shaft 112 can include one or more lumens (e.g., a source fluid lumen and a suction lumen), which can be fluidically connected to the irrigation fluid port 108 and the suction port 110, respectively, to provide irrigation fluid from the irrigation fluid source 114 to the distal end of the shaft 112 and draw outflow fluid, fluid, or the like away from the distal end of the shaft 112. Thus, the irrigation line 116 can be routed partially within the handle 106 to fluidically connect a distal end of the shaft 112 to the irrigation fluid source 114, and the suction line 122 can be routed partially within the handle 106 to fluidically connect the shaft 112 to the suction source 120.
[0038] The purging device 124 can be fluidically connected to the suction line 122 between the suction source 120 and the shaft 112. The purging device 124 can be configured to generate a positive pressure pulse to clear outflow fluid accumulated within either the shaft 112 or the suction line 122. In examples, the purging device 124 can be completely enclosed by the handle 106, can partially extend outside the handle 106, or can be completely outside of the handle 106.
[0039] The control module 130 can be configured to operate the endoscopic system 100, and more specifically, the endoscope 104 and the purging device 124, based on information from one or more of the user via the user interface 128, a pressure within the system detected by the pressure monitor 132, pump readings from either of the inflow pump 118 or the suction source 120, power readings from the power source 134, or any other component of the endoscopic system 100. In examples, the control module 130 can generate control signals to alter operational parameters of the inflow pump 118 to alter the amount of irrigation fluid from the irrigation fluid source 114 flowing to the distal end of the shaft 112. The control module 130 can send a control signal to increase a suction provided to the endoscopic system 100 via the suction source 120 to increase an amount of fluid or outflow fluid being drawn from the distal end of the shaft 112. The control module 130 can send a control signal toDocket No. 5409.906W01 / / GAP24043-SUSF-WO 1 operate the purging device 124 to help clear any clogs, kinks, blockages, or any combination thereof in the shaft 112 or the suction line 122.
[0040] FIG. 2 illustrates an example diagram of a portion of an example endoscope 104, including an example valve 204 in an example bypass line 202. The endoscope 104 can be configured to perform a medical procedure at a surgical site within a patient. For example, the endoscope 104 can be used for ablation, removal, or collection of stones, tissue, or the like within a patient. The endoscope 104 can be insertable within a patient via another scope (e.g., a mother-daughter scope) or directly without the aid of another scope. In examples, the endoscope 104 can include an irrigation line 116, a suction line 122, a bypass line 202, a valve 204, and a sealing member 208.
[0041] As discussed herein, the irrigation line 116 can be configured to direct fluid (e.g., saline, water, any other biocompatible irrigation fluid, or the like) toward a surgical site of a patient. The suction line 122 can be configured to draw the fluid and outflow fluid (e.g., stones, fragments of stones, tissue, blood, or the like) away from the surgical site. The bypass line 202 can extend between the irrigation line 116 and the suction line 122 to fluidically connect the irrigation line 116 to the suction line 122 and decrease the amount of fluid directed toward the surgical site.
[0042] As shown in FIG. 2, an irrigation line diameter 216 can be smaller than a suction line diameter 218 and a bypass line diameter 220. The smaller diameter of the irrigation line diameter 216 than the suction line diameter 218 and the bypass line diameter 220 encourages fluid from the irrigation line 116 to flow to the suction line 122 via the bypass line 202 when the valve 204 is opened to permit fluid flow in the bypass line 202. In examples, the diameters of the suction line diameter 218 and the bypass line diameter 220 can be similar. In examples, the bypass line diameter 220 can change as the bypass line 202 extends from the irrigation line 116 to the suction line 122. For example, as shown in FIG. 2, the bypass line diameter 220 can increase as the bypass line 202 extends from the irrigation line 116 toward the suction source via the suction line 122. In other words, the bypass line diameter 220 can change such that adjacent to the irrigation line 116, the bypass line diameter 220 is smaller than the bypass line diameter 220 adjacent to the suction line 122. The taper of the bypass line diameter 220 in the bypass line 202 can help the valve 204 operate. For example, because the bypass line diameter 220 is tapered, translation of a valve plug (e.g., a valve body 206) toward the suction line 122 can disengage the valve body 206 (or theDocket No. 5409.906W01 / / GAP24043-SUSF-WO 1 sealing member 208) from the inner surface of the bypass line 202 to permit fluid flow through the bypass line 202). In contrast, as the valve body 206 translates toward the irrigation line 116, the valve body 206, the sealing member 208, or a combination thereof, can contact the inner wall of the bypass line 202 to decrease fluid flow through the bypass line 202.
[0043] The sealing member 208 can be inserted within the bypass line 202 to seal the valve 204 and mitigate the fluid going around the valve 204 while the valve 204 is in a position to block fluid flow through the bypass line 202. The sealing member 208 can be an o-ring, u-ring, another seal configured to mitigate fluid flow, a combination thereof, or the like. In examples, the sealing member 208 can include rubber, polymer, metals, composites, combinations or alloys thereof, or the like. In examples, the sealing member 208 can be attached to the bypass line 202 to help position the valve 204 therein the bypass line 202. In another example, the sealing member 208 can be connected to the valve 204 such that the sealing member 208 actuates with the valve 204 as the valve 204 moves between open and closed positions.
[0044] As shown in FIG. 2, the valve 204 can be installed within the bypass line 202 to prevent or permit fluid flow through the bypass line 202. In examples, the valve 204 can be configured to operate between an open position 302 (first shown in FIG. 3) and a closed position 214. In the closed position 214 the valve 204 can be configured to block (or mitigate) fluid flow through the bypass line 202. For example, as shown in FIG. 2, in the closed position 214, the valve 204, or more specifically, the valve body 206 or the sealing member 208, can contact the inner walls of the bypass line 202 to prevent (or reduce) fluid flow through the bypass line 202. In the open position 302, the valve 204 can be configured to permit fluid flow through the bypass line 202. The valve 204 can be a passive valve, an active valve, or a combination thereof. In examples, the valve 204 can be a passive valve such that no controls are included operate the valve 204. To operate the valve 204, the valve 204 can include a valve body 206, a biasing member 210, and a permeable shelf 212.
[0045] The biasing member 210 can be configured to encourage the valve 204 into the closed position 214. As shown in FIG. 2, the biasing member 210 can extend between the valve body 206 and the permeable shelf 212. The biasing member 210 can be configured to apply a force to the valve body 206 to maintain contact between the valve body 206 and the bypass line 202 or the sealing member 208 and the bypass line 202. A stiffness of the biasing member 210 can determine a pressure at which the valveDocket No. 5409.906W01 / / GAP24043-SUSF-WO 1204 opens. For example, the stiffness of the sealing member 208 can be adjusted such that the valve 204 opens at different pressures within the irrigation line 116. As such, the stiffness of the sealing member 208 can be the pressure threshold value at which the valve 204 actuates and begins to permit fluid through the bypass line 202.
[0046] The permeable shelf 212 can be configured to operate between a closed configuration (shown in FIG. 2) and an open configuration (shown in FIG. 3). In the closed configuration, the permeable shelf 212 can prevent (or decrease an amount of) fluid flow from the suction line 122 to the irrigation line 116 via the bypass line 202. The permeable shelf 212 can include elastic materials such that the biasing member 210 can engage the permeable shelf 212 to actuate the permeable shelf 212 between the open and closed configurations. In examples, the valve 204 can still be used without the permeable shelf 212, but outflow fluid can collect on the biasing member 210 or within the bypass line 202. Thus, the permeable shelf 212 can help prevent outflow fluid build-up and ensure that the valve 204 operational.
[0047] The positioning of the permeable shelf 212 and the valve 204 within the bypass line 202 can also be reversed. In such an example, In the closed configuration, the permeable shelf 212 can prevent (or decrease an amount of) fluid flow from irrigation line 116 to the suction line 122 via the bypass line 202. The permeable shelf 212 can include elastic materials such that the biasing member 210 can engage the permeable shelf 212 to actuate the permeable shelf 212 between the open and closed configurations. The valve 204 can then be configured to block fluid from the suction line 122 to the irrigation line 116 via the bypass line 202.
[0048] In examples, the endoscope 104 can also include a sensor configured to determine a position of the valve 204. The sensor can be a motion sensor, optical sensor, proximity sensor, magnetic (e.g., Hall effect) sensor, or the like. For example, the sensor can be configured to detect a position of the valve body 206, the biasing member 210, or the permeable shelf 212 to determine if the valve 204 is in the closed position 214 or the open position 302. The sensor can be configured to detect pressure within the irrigation line 116, the suction line 122, or at the surgical site or to detect an operating state (e.g., open or closed positions) of the valve 204. A controller of the endoscope 104 or the endoscopic system 100 (FIG. 1), such as the control module 130 (FIG .1) or the pressure monitor 132 (FIG. 1), can receive the pressure and transmit a control signal to one or more of the inflow pump 118 (FIG. 1), the suction source 120 (FIG. 1), or the power source 134 (FIG. 1) to increase or decrease the pumps or turnDocket No. 5409.906W01 / / GAP24043-SUSF-WO 1 off the power to the system. The controller can also be configured to generate an alert (e.g., haptic feedback, visual representation on the user interface 128 (FIG. 1), or audible indication) to notify the medical team that a pressure above or near the threshold was detected. More examples of sensors and controllers will be discussed herein.
[0049] FIG. 3 illustrates an example diagram of a portion of an example endoscope 104, including an example valve 204 installed within an example bypass line 202 and in an open position 302. In the open position 302, the valve 204 is configured to permit fluid flow from the irrigation line 116 to the suction line 122 to reduce an amount of new fluid introduced to the surgical site.
[0050] As the pressure within the irrigation line 116 exceeds the threshold value, the biasing member 210 can begin to compress, and because the irrigation line 116 is tapered (as shown in FIG. 2), as the biasing member 210 compresses, the valve body 206 (or the sealing member 208) disengages from the inner walls of the bypass line 202 to permit fluid flow from the irrigation line 116 to the suction line 122. The opening of the valve 204 helps mitigate pressure buildup within the irrigation line 116 beyond the valve 204 (and toward the surgical site). Decreasing the pressure within the irrigation line 116 and the surgical site can result in a lower likelihood of damaging components of the endoscopic system (e.g., the endoscopic system 100, see FIG. 1).
[0051] The compression of the biasing member 210 can also actuate the permeable shelf 212 into the open position. In the open position, the permeable shelf 212 can be configured to permit fluid flow from the irrigation line 116 and into the suction line 122 via the bypass line 202. As the pressure within the irrigation line 116 decreases, the biasing member 210 can expand. The expansion of the biasing member 210 can reduce the fluid permitted to flow through the valve 204 and the permeable shelf 212. In examples, the biasing member 210 can return to the expanded position (as shown in FIG. 2), and the valve 204 and the permeable shelf 212 can prevent (or limit) fluid flow through the bypass line 202.
[0052] FIG. 4 illustrates an example diagram of a portion of an example endoscope 104, including an example valve 400 in an example bypass line 202. As shown in FIG. 4, the bypass line 202 can be tapered such that a bypass line diameter (e.g., bypass line diameter 220, shown in FIG. 2) can increase as the bypass line 202 extends from the irrigation line 116 to the suction line 122. The increase in the bypass line diameter encourages fluid flow through the bypass line 202 when the valve 400 isDocket No. 5409.906W01 / / GAP24043-SUSF-WO 1 in the open position (e.g., open position 500, see FIG. 5). The sealing member 208 can be installed within the bypass line 202 to secure the valve 400 within the bypass line 202 and mitigate fluid flow around the valve 400.
[0053] The valve 400 can be passive, so no controls are included to be included to operate the valve 400. To passively control the fluid flow through the valve 400, the valve 400 can include an elastic orifice 402. The elastic orifice 402 can be configured to bias the valve 400 into the closed position 406, as shown in FIG. 4. The elastic orifice 402 can define a lumen 404 extending through the valve 400. In a closed position 406, the elastic orifice 402 can be configured to mitigate fluid flow through the lumen 404 such that the fluid in the irrigation line 116 can be directed toward the surgical site and fluid and outflow fluid in the suction line 122 can be directed away from the surgical site and toward a suction source (e.g., the suction source 120, see FIG. 1).
[0054] In examples, the elastic orifice 402 can be configured to actuate from the closed position 406 toward the open position 500 upon pressures above a threshold value in the irrigation line 116. As the valve 400 moves from the closed position 406 toward the open position 500, the valve 400 can permit fluid flow from the irrigation line 116 through the valve 400 and toward the suction line 122. A stiffness of the elastic orifice 402 can be adjusted to alter the threshold value that the valve 400 starts to open to permit fluid flow from the irrigation line 116 toward the suction line 122. For example, the stiffness of the elastic orifice 402 can be increased to increase the threshold at which the elastic orifice 402 begins to open the lumen 404, or the stiffness of the elastic orifice 402 can be decreased to decrease the threshold at which the elastic orifice 402 begins to open the lumen 404.
[0055] As discussed herein, sensors can be included in the endoscope 104 to detect pressure within the irrigation line 116, the suction line 122, or at the irrigation site or detect a position of the valve 400. For example, the sensors can be configured to detect a position of the elastic orifice 402 to determine if the sensor is in the closed position 406 or the open position 500. For example, the sensor can be a proximity sensor or a motion sensor to detect a position of the elastic orifice 402. In another example, the sensor can be an optical sensor configured to determine the status of the lumen 404 (e.g., whether the valve is in the closed position 406 or the open position 500).Docket No. 5409.906W01 / / GAP24043-SUSF-WO 1
[0056] FIG. 5 illustrates an example diagram of a portion of an example endoscope 104, including an example valve 400 in an example bypass line 202. As shown in FIG. 5, the valve 400 is rotated one hundred and eighty degrees from the valve 400 shown in FIG. 4. As shown in FIG. 5, the bypass line 202 can be tapered such that a bypass line diameter (e.g., the bypass line diameter 220, shown in FIG. 2) can decrease as the bypass line 202 extends from the irrigation line 116 to the suction line 122. The sealing member 208 can be installed within the bypass line 202 to hold the valve 400 within the bypass line 202 and mitigate fluid leak around the valve 400. As the taper gets smaller as the bypass line 202 extends toward the suction line 122, the seating of the valve 400 within the bypass line 202 is easier to maintain because the fluid in the irrigation line 116 can apply pressure from the irrigation line 116 side of the valve 400 to help secure the valve 400 within the bypass line 202.
[0057] As shown in FIG. 5, as the pressure within the irrigation line 116 increases beyond the threshold, the lumen 404 opens as the elastic orifice 402 expands, moving the valve 400 into the open position 500. In the open position 500, the valve 400 can fluidically connect the irrigation line 116 and the suction line 122. Thus, fluid from within the irrigation line 116 can flow through the bypass line 202 and to the suction line 122, avoiding the surgical site. Bypassing the surgical site and sending fluid through the bypass line 202 helps mitigate pressures within the irrigation line 116 and the surgical site.
[0058] FIG. 6 illustrates an example diagram of a portion of an example endoscope 104, including an example valve 600 in an example bypass line 202. The example valve 600 can be a non-passive valve such that fluid flow through the bypass line 202 can be actively controlled by one or more controllers and the valve 600. To control the fluid flow through the bypass line 202, the valve 600 can include a flexible member 602 that can define a lumen 606. The lumen 606 can be configured to direct the fluid from the irrigation line 116 to the suction line 122. As shown in FIG. 6 and FIG. 7, the irrigation line 116 can include a smaller diameter (e.g., irrigation line diameter 216, see FIG. 2) than the diameter of the suction line 122 (e.g., the bypass line diameter 220, see FIG. 2). Because the diameter of the irrigation line 116 is smaller than the diameter of the suction line 122, the fluid within the irrigation line 116 will flow through the bypass line 202 to the suction line 122 when the valve 600 is opened.Docket No. 5409.906W01 / / GAP24043-SUSF-WO 1
[0059] As shown in FIG. 6, an actuator 604, a pressure sensor 608, and a controller 610 can be included to control the opening and closing of the valve 600 (e.g., actuation of the flexible member 602 to open or close the lumen 606. The actuator 604 can be configured to move the flexible member 602 between a closed position 612 and an open position 702 (FIG. 7). The pressure sensor 608 can be installed in communication with the irrigation line 116 to detect pressure within the irrigation line 116. The controller 610 can be configured to receive a signal from the pressure sensor 608 and based on the detected pressure of the irrigation line 116 transmit a controlling signal to the actuator 604 to actuate the flexible member 602. For example, if the pressure within the irrigation line 116 detected by the pressure sensor 608 is beneath the threshold, the controller 610 can transmit a signal to the actuator 604 to move the flexible member 602 in a position to block the lumen 606 and move the valve 600 into the closed position 612. In the closed position 612, the flexible member 602 can be configured to close the lumen 606 and block fluid from flowing between the irrigation line 116 and the suction line 122.
[0060] In examples, the controller 610 can transmit a signal to the inflow pump (e.g., the inflow pump 118, see FIG. 1) or the outflow pump (e.g., the suction source 120, see FIG. 1) on condition of receiving a signal from the pressure sensor 608 that is indicative of pressure changes in within any of the irrigation line 116, the suction line 122, or at the surgical site. For example, if the pressure detected by the pressure sensor 608 indicates the pressure within the surgical site, the irrigation line 116, or the suction line 122 are too high, the controller 610 can transmit a signal to the inflow pump to decrease the fluid provided to the irrigation line 116. The controller 610 can also transmit a signal to the outflow pump to increase a suction provided to the suction line 122 upon the detected pressure indicating pressures are too high within the irrigation line 116, the suction line 122, or the surgical site.
[0061] FIG. 7 illustrates an example diagram of a portion of an example endoscope 104, including an example valve 600 in an example bypass line 202. As the pressure in the irrigation line 116 exceeds the threshold, the controller 610 can receive the signal from the pressure sensor 608 and determine the pressure within the irrigation line 116 exceeds the threshold, generate a control signal, and transmit the control signal to the actuator 604. Upon receiving the control signal from the controller 610, the actuator 604 can move the flexible member 602 to open up the lumen 606 and move the valve 600 into the open position 702 to permit fluid flow from the irrigationDocket No. 5409.906W01 / / GAP24043-SUSF-WO 1 line 116 into the suction line 122 via the bypass line 202. The fluid flow from the irrigation line 116 to the suction line 122 via the bypass line 202 can help mitigate pressure buildups within the endoscope 104 or at the surgical site.
[0062] In examples, the controller 610 can include multiple thresholds; each threshold can correlate to the controller 610 opening the valve 600 at different percentages. For example, the highest threshold can be set to move valve 600 fully open, such that the flexible member 602 is fully retracted and the lumen 606 is a increased toward a maximum diameter to encourage fluid flow from the irrigation line 116 into the suction line 122 via the bypass line 202. The controller 610 can include many thresholds correlating to different openings between fully open (e.g., the open position 702) and fully closed (e.g., the closed position 612).
[0063] FIG. 8 and FIG. 9 illustrate examples of a modulating orifice valve 800 in an open position 808 (FIG. 8) and a closed position 902 (FIG. 9). The modulating orifice valve 800 can be installed within the bypass line 202 in place of any of the valves (e.g., the valve 204 (FIG. 2), the valve 400 (FIG. 4), or the valve 600 (FIG. 6) to control fluid flow between the irrigation line (e.g., irrigation line 116, see FIG. 1) and the suction line (e.g., suction line 122, see FIG. 1). As shown in FIG. 9, the modulating orifice valve 800 can include a lever 804 connected to the actuator 604. The actuator 604 can be configured to move the lever 804 based to alter the orifice diameter 802 of the modulating orifice valve 800 based on pressures detected within the irrigation line 116 detected by pressure sensors (e.g., the pressure sensor 608, see FIG. 6).
[0064] In standard operation of the endoscope (e.g., the pressure within the irrigation line is at or below a threshold) the actuator 604 can maintain the modulating orifice valve 800 in the closed position (e.g., the closed position 902, shown in FIG. 9). As the pressure in the irrigation line or at the surgical site raises beyond the threshold, the actuator 604 can open the modulating orifice valve 800 to increase the orifice diameter 802 and move the modulating orifice valve 800 toward the open position 808. As the pressure detected within the irrigation line or at the surgical site attenuates below the threshold, the controller 610 can transmit a signal to the actuator 604 to move the lever 804 to close the orifice diameter 802 toward the closed position 902. In the closed position 902, the modulating orifice valve 800 can be configured to mitigate fluid flowing through the modulating orifice valve 800 to guide fluid to the surgical site from the irrigation line and draw fluid and outflow fluid away from the surgicalDocket No. 5409.906W01 / / GAP24043-SUSF-WO 1 site in the suction line with minimal fluid flow through the bypass line (e.g., the bypass line 202, see FIG. 2).
[0065] FIG. 10 and FIG. 11 illustrate examples diagram of an example endoscope 104, including an example pressure-regulating reservoir 1002. As shown in FIG. 10, the pressure-regulating reservoir 1002 can be in the deflated configuration 1004 and as shown in FIG. 11, the pressure-regulating reservoir 1002 can be in the expanded configuration 1102. In the examples shown in FIG. 10 and FIG. 11, the pressure-regulating reservoir 1002 can be connected to the suction line 122. In other examples, the pressure-regulating reservoir 1002 can be installed on the irrigation line 116, the suction line 122, or both the irrigation line 116 and the suction line 122. In examples, the irrigation line 116 and the shaft 112 can each include their own pressureregulating reservoir 1002. In another example, a single pressure-regulating reservoir 1002 can be connected to each of the irrigation line 116 and the suction line 122 to help regulate pressure in both the irrigation line 116 and the suction line 122 simultaneously. The pressure-regulating reservoir 1002 can be installed within the handle (e.g., the handle 106, see FIG. 1), or partially within the handle of the endoscope 104.
[0066] As shown in FIG. 10, during normal operation of the endoscope 104, the pressure-regulating reservoir 1002 can be in the deflated configuration 1004 as the pressure within the suction line 122 is within a threshold value. As the pressure within the suction line 122 goes beyond (e.g., above) the threshold value, the deflated configuration 1004 can expand to the expanded configuration 1102. The expansion of the pressure-regulating reservoir 1002 can help mitigate pressure building in the suction line 122 to prevent damage to components of the endoscope 104. In examples, the pressure within the suction line 122 can increase because of a clog, kink, or other blockage of the suction line 122, preventing proper suction through the suction line 122. The pressure-regulating reservoir 1002 can provide the medical professionals additional time to address the issues causing the pressure buildup while limiting the pressure buildup within the suction line 122. As the pressure within the suction line 122 falls toward the threshold value (e.g., as the issue causing the increased pressure within the suction line 122 is fixed by the medical professionals), the pressureregulating reservoir 1002 can be configured to retract back toward the deflated configuration 1004, as shown in FIG. 11.Docket No. 5409.906W01 / / GAP24043-SUSF-WO 1
[0067] An elasticity of the pressure-regulating reservoir 1002 can be configured to match a threshold value based on the medical procedure that the endoscope 104 will be configured to be used for. For example, if there is a medical procedure with higher pressures within the endoscope 104, the pressure-regulating reservoir 1002 can include an elasticity that is less responsive to pressure increases such that the pressure within the endoscope 104 (e.g., the irrigation line 116 or the suction line 122) can increase beyond a higher pressure to move the pressureregulating reservoir 1002 from the deflated configuration 1004 toward the expanded configuration 1102.
[0068] The endoscope 104 can also include a sensor 1006. The sensor 1006 can be configured to detect displacement, translation, or other movement of the pressureregulating reservoir 1002, pressure, or the like. For example, the sensor 1006 can detect when the pressure-regulating reservoir 1002 actuates from the deflated configuration 1004 toward the expanded configuration 1102. The sensor 1006 can also be configured to detect pressure within the irrigation line 116, the suction line 122, at the surgical site. The sensor 1006 can be in communication with a controller 1010 (e.g., the control module 130 or the pressure monitor 132, both in FIG. 1).
[0069] The controller 1010 can be configured to receive a signal from the sensor 1006 and determine that the pressure-regulating reservoir 1002 is expanding or that pressure within the suction line 122 (or the irrigation line 116) expands beyond the threshold value and generate an alert in response to either the movement of the pressure-regulating reservoir 1002 or the pressure increase within the suction line 122. In response to the signal from the sensor 1006, the controller 1010 can generate an alert to a user interface (e.g., the user interface 128) to communicate the detected state so the medical professionals can intervene with the endoscope 104 and remedy the issue causing the pressure increase. The controller 1010 can also be configured to transmit control signals to one or more of the inflow pump 118, the suction source 120, the power source 134, or the like to control fluid (or fluid and outflow fluid) flow or power to the system. For example, the controller 1010 can transmit a signal to increase, decrease, or stop either the inflow pump 118 or the suction source 120 or to turn off the system by sending a signal to the power source 134.
[0070] FIG. 12 illustrates an example diagram of an example endoscope 104, including an example pressure-regulating reservoir 1002. As shown in FIG. 12, the pressure-regulating reservoir 1002 can be connected to the suction line 122. In otherDocket No. 5409.906W01 / / GAP24043-SUSF-WO 1 examples, the pressure-regulating reservoir 1002 can be installed on the irrigation line 116, the suction line 122, or both the irrigation line 116 and the suction line 122. In examples, the irrigation line 116 and the shaft 112 can each include their own pressureregulating reservoir 1002. In another example, a single pressure-regulating reservoir 1002 can be connected to each of the irrigation line 116 and the suction line 122 to help regulate pressure in both the irrigation line 116 and the suction line 122 simultaneously. The pressure-regulating reservoir 1002 can include a valve 1202 installed between the pressure-regulating reservoir 1002 and the suction line 122.
[0071] The valve 1202 can determine the threshold at which fluid (or outflow fluid) will flow into the pressure-regulating reservoir 1002 to move the pressureregulating reservoir 1002 from the deflated configuration 1004 (FIG. 10) toward the expanded configuration 1102 (FIG. 11). Thus, the same pressure-regulating reservoir 1002 can be used for multiple different medical procedures, but the valve 1202 can be selectively installed to alter the threshold value of the fluid flow into the pressureregulating reservoir 1002 to adjust the endoscope 104 for the appropriate medical procedure.
[0072] FIG. 13 illustrates an example diagram of an example endoscope 104, including an example pressure-regulating reservoir 1002. As shown in FIG. 12, the pressure-regulating reservoir 1002 can be connected to the suction line 122. In other examples, the pressure-regulating reservoir 1002 can be installed on the irrigation line 116, the suction line 122, or both the irrigation line 116 and the suction line 122. In examples, the irrigation line 116 and the shaft 112 can each include their own pressureregulating reservoir 1002. In another example, a single pressure-regulating reservoir 1002 can be connected to each of the irrigation line 116 and the suction line 122 to help regulate pressure in both the irrigation line 116 and the suction line 122 simultaneously.
[0073] The pressure-regulating reservoir 1002 can include a pressure relief valve 1302 installed in fluidic communication with the pressure-regulating reservoir 1002. The pressure relief valve 1302 can be configured to release fluid within the pressure-regulating reservoir 1002 as the pressure within the pressure-regulating reservoir 1002 exceeds a threshold value to maintain the pressure within the pressureregulating reservoir 1002 (and the irrigation line 116 or the suction line 122) below a pressure threshold. In examples, the pressure relief valve 1302 can be fluidicallyDocket No. 5409.906W01 / / GAP24043-SUSF-WO 1 connected to a waste collection unit to capture the fluid released via the pressure relief valve 1302.
[0074] FIG. 14 illustrates an example diagram of an example endoscope 104, including an example pressure-regulating reservoir 1002. including an example valve and a pressure relief valve. As shown in FIG. 12, the pressure-regulating reservoir 1002 can be connected to the suction line 122. In other examples, the pressureregulating reservoir 1002 can be installed on the irrigation line 116, the suction line 122, or both the irrigation line 116 and the suction line 122. In examples, the irrigation line 116 and the shaft 112 can each include their own pressure-regulating reservoir 1002. In another example, a single pressure-regulating reservoir 1002 can be connected to each of the irrigation line 116 and the suction line 122 to help regulate pressure in both the irrigation line 116 and the suction line 122 simultaneously.
[0075] The pressure-regulating reservoir 1002 can include a valve 1202 connected between the pressure-regulating reservoir 1002 and the suction line 122 and a pressure relief valve 1302 installed in fluidic communication with the pressureregulating reservoir 1002. The valve 1202 can determine the threshold at which fluid (or outflow fluid) will flow into the pressure-regulating reservoir 1002 to move the pressure-regulating reservoir 1002 from the deflated configuration 1004 (FIG. 10) toward the expanded configuration 1102 (FIG. 11). Thus, the same pressure-regulating reservoir 1002 can be used for multiple different medical procedures, but the valve 1202 can be selectively installed to alter the threshold value of the fluid flow into the pressure-regulating reservoir 1002 to adjust the endoscope 104 for the appropriate medical procedure. The pressure-regulating reservoir 1002 can include a pressure relief valve 1302 installed in fluidic communication with the pressure-regulating reservoir 1002. The pressure relief valve 1302 can be configured to release fluid within the pressure-regulating reservoir 1002 as the pressure within the pressure-regulating reservoir 1002 exceeds a threshold value to maintain the pressure within the pressureregulating reservoir 1002 (and the irrigation line 116 or the suction line 122) below a pressure threshold. In examples, the pressure relief valve 1302 can be fluidically connected to a waste collection unit to capture the fluid released via the pressure relief valve 1302.
[0076] FIG. 15 illustrates an example diagram of an example endoscope 104 including a first pressure-regulating reservoir 1502 and a second pressure-regulating reservoir 1504. The first pressure-regulating reservoir 1502 (e.g., the pressure-Docket No. 5409.906W01 / / GAP24043-SUSF-WO 1 regulating reservoir 1002, first shown in FIG. 10) can be installed in fluidic communication with the irrigation line 116. The second pressure-regulating reservoir 1504 (e.g., the pressure-regulating reservoir 1002) can be installed in fluidic communication with the suction line 122. In examples, the first pressure-regulating reservoir 1502 and the second pressure-regulating reservoir 1504 can include different elasticities so that they include different thresholds that they move from the deflated configuration (e.g., the deflated configuration 1004, first shown in FIG. 10) and the expanded configuration (e.g., the expanded configuration 1102, first shown in FIG. 11). In another example, the first pressure-regulating reservoir 1502 and the second pressure-regulating reservoir 1504 can include the same elasticity such that they both include the same threshold value at which they move from the deflated configuration toward the expanded configuration.
[0077] In examples, either, or both, of the first pressure-regulating reservoir 1502 and the second pressure-regulating reservoir 1504 can include one or more of the valve (e.g., the valve 1202, first shown in FIG. 12) or the pressure relief valve (e.g., the pressure relief valve 1302, first shown in FIG. 13).
[0078] FIG. 16 shows a schematic diagram of an example computer-based clinical decision support system Computer-based clinical decision support system (CDSS), hereinafter referred to as a CDSS 1600, that is configured to control one or more aspects of the endoscopic system 100, based on input from any one of the components of the endoscopic system (e.g., the inflow pump 118, the suction source 120, the user interface 128, the control module 130, the pressure monitor 132, or the power source 134 (shown in FIG. 1). In examples, the CDSS 1600 can include an input interface 1604 (e.g., the user interface 128 (FIG. 1) through which medical information, such as, age, weight, sex, which are specific to a patient, or procedure specific information, such as, location of anomaly, planned path for the procedure, planned steps of the procedure, or the like, can be provided as input features to an artificial intelligence (Al) Al model 1606. A processor 1608 (e.g., the control module 130, see (FIG. 1) which performs an inference operation in which the input from any one of the components of the endoscopic system, signals transmitted based on engagement with either of the first engagement member or the second engagement member, medical information, procedure specific information, or the like, are applied to the Al model to generate a suggested medical procedure, and a user interface (UI)Docket No. 5409.906W01 / / GAP24043-SUSF-WO 1 through which suggested medical procedure is communicated to a user, e.g., a clinician.
[0079] The input interface 1604 can be a direct data link between the CDSS 1600 and one or more medical devices (e.g., the endoscopic system 100), that generate some of the input features. For example, the input interface 1604 can transmit input from any one of the components of the endoscopic system, medical information, procedure-specific information, or the like, directly to the CDSS 1600 during a therapeutic and / or diagnostic medical procedure. Additionally, or alternatively, the input interface 1604 can be a classical user interface that facilitates interaction between a user and the CDSS 1600. For example, the input interface 1604 can facilitate a user interface through which the user can manually enter medical information, procedure specific information, or the like. Additionally, or alternatively, the input interface 1604 can provide the CDSS 1600 with access to an electronic patient record from which one or more input features can be extracted. Such electronic patient records can be stored on a database 1602. In any of these cases, the input interface 1604 can be configured to collect one or more of the following input features in association with a specific patient on or before a time at which the CDSS 1600 is used to assess the safest and efficient procedure to complete a planned medical procedure.
[0080] Based on one or more of the above input features, the processor 1608 performs an inference operation using the Al model 1606 to generate the safest and most efficient medical procedure to perform the medical task. For example, input interface 1604 can deliver any of the medical information, medical procedure information, outputs from any one of the components of the endoscopic system, or signals transmitted based on engagement with either of the first engagement member or the second engagement member into an input layer of the Al model 1606, which propagates these input features through the Al model 1606 to an output layer. The Al model 1606 can provide a computer system the ability to perform tasks, without explicitly being programmed, by making inferences based on patterns found in the analysis of data. The Al model 1606 explores the study and construction of algorithms (e.g., machine-learning algorithms) that can learn from existing data and make predictions about new data. Such algorithms operate by building an Al model from example training data in order to make data-driven predictions or decisions expressed as outputs or assessments.Docket No. 5409.906W01 / / GAP24043-SUSF-WO 1
[0081] In examples, the CDSS 1600 can also be used to control one or more of the inflow pump 118, the suction source 120, the user interface 128, the control module 130, the pressure monitor 132, the power source 134, or the purging device 124) based on any information collected via the components of the endoscopic system 100 or from the patient information provided to the endoscopic system 100 or the CDSS 1600.
[0082] There are two common modes for machine learning (ML): supervised ML and unsupervised ML. Supervised ML uses prior knowledge (e.g., examples that correlate inputs to outputs or outcomes) to learn the relationships between the inputs and the outputs. The goal of supervised ML is to learn a function that, given some training data, can approximate the relationship between the training inputs and outputs so that the ML model can implement the same relationships when given inputs to generate the corresponding outputs. Unsupervised ML is the training of an ML algorithm using information that is neither classified nor labeled, and allowing the algorithm to act on that information without guidance. Unsupervised ML is useful in exploratory analysis because it can automatically identify structure in data.
[0083] Common tasks for supervised ML are classification problems and regression problems. Classification problems, also referred to as categorization problems, aim at classifying items into one of several category values (for example, is this object an apple or an orange?). Regression algorithms aim at quantifying some items (for example, by providing a score to the value of some input). 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).
[0084] Some common tasks for unsupervised ML include clustering, representation learning, and density estimation. Some examples of commonly used unsupervised-ML algorithms are K-means clustering, principal component analysis, and auto-encoders.
[0085] Another type of ML is federated learning (also known as collaborative learning) that trains an algorithm across multiple decentralized devices holding local data, without exchanging the data. This approach stands in contrast to traditional centralized machine-learning techniques where the local datasets are uploaded to one server, as well as to more classical decentralized approaches which often assume that local data samples are identically distributed. Federated learning enables multiple actors to build a common, robust machine learning model without sharing data, thusDocket No. 5409.906W01 / / GAP24043-SUSF-WO 1 allowing the system to address issues such as data privacy, data security, data access rights and access to heterogeneous data.
[0086] The Al model can be trained continuously or periodically prior to the performance of the inference operation by the processor 1608. Then, during the inference operation, the patient-specific input features provided to the Al model can be propagated from an input layer through one or more hidden layers and ultimately to an output layer that corresponds to the suggested medical procedure. For example, if the age of the patient, the size of the patient, or any other medical information of the patient, and the medical information, such as the location of the patient indicates the sample can be difficult to obtain, the processor 1608 can suggest a smaller version of the endoscope, suggest a different path that can increase imaging and sampling efforts, or suggest an increased energy used for any cutting, ablation, or removal procedures.
[0087] During and / or subsequent to the inference operation, the output interface 1610 can transmit any of the safest and efficient medical procedures that can be communicated to the user via the user interface (UI) and / or automatically cause any component of the endoscopic system for performing a desired action. For example, if the imaging quality is poor, the processor 1608 can transmit a signal to the light source control unit to alter the brightness, color, saturation, or any other light parameter, of the light transmitted, send a controlling signal to the fluid source to change a fluid supplied to the pump(s), send a signal to the pump(s) to alter a velocity or volume of fluid supplied to the imaging site, send a signal to the pump(s) to increase or decrease an amount of suction provided to the imaging site. These are exemplary actions that can be taken by the CDSS 1600 to aid in the instruction and procedure of the medical procedure. However, the inventors of the present disclosure include contemplated how the CDSS 1600 can help with any aspect of the medical procedure, such as planning preoperatively, performing intraoperatively, or analyzing the procedure postoperatively, or the like.
[0088] FIG. 17 illustrates a block diagram of an example machine 1700 upon which any one or more of the techniques (e.g., methodologies) discussed herein can perform. Examples, as described herein, can include, or can operate by, logic or a number of components, or mechanisms in the machine 1700. Circuitry (e.g., processing circuitry) is a collection of circuits implemented in tangible entities of the machine 1700 that include hardware (e.g., simple circuits, gates, logic, etc.). Circuitry membership can be flexible over time. Circuitries include members that can, alone orDocket No. 5409.906W01 / / GAP24043-SUSF-WO 1 in combination, perform specified operations when operating. In examples, hardware of the circuitry can be immutably designed to carry out a specific operation (e.g., hardwired). In an example, the hardware of the circuitry can include variably connected physical components (e.g., execution units, transistors, simple circuits, etc.), including a machine-readable medium physically modified (e.g., magnetically, electrically, moveable placement of invariant massed particles, etc.) to encode instructions of the specific operation. In connecting the physical components, the underlying electrical properties of a hardware constituent are changed, for example, from an insulator to a conductor or vice versa. The instructions enable embedded hardware (e.g., the execution units or a loading mechanism) to create members of the circuitry in hardware via the variable connections to carry out portions of the specific operation when in operation. Accordingly, in an example, the machine-readable medium elements are part of the circuitry or are communicatively coupled to the other components of the circuitry when the device is operating. In examples, any of the physical components can be used in more than one member of more than one circuitry. For example, under operation, execution units can be used in a first circuit of a first circuitry at one point in time and reused by a second circuit in the first circuitry, or by a third circuit in a second circuitry at a different time. Additional examples of these components with respect to the machine 1700 follow.
[0089] In alternative examples, the machine 1700 can operate as a standalone device or can be connected (e.g., networked) to other machines. In a networked deployment, the machine 1700 can operate in the capacity of a server machine, a client machine, or both in server-client network environments. In an example, the machine 1700 can act as a peer machine in peer-to-peer (P2P) (or other distributed) network environment. The machine 1700 can be a personal computer (PC), a tablet PC, a set- top box (STB), a personal digital assistant (PDA), a mobile telephone, a web appliance, a network router, switch or bridge, or any machine capable of executing instructions (sequential or otherwise) that specify actions to be taken by that machine. Further, while a single machine is illustrated, the term “machine” shall also be taken to include any collection of machines that individually or jointly execute a set (or multiple sets) of instructions to perform any one or more of the methodologies discussed herein, such as cloud computing, software as a service (SaaS), other computer cluster configurations.Docket No. 5409.906W01 / / GAP24043-SUSF-WO 1
[0090] The machine 1700 can include a hardware processor 1702 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof), a main memory 1704, a static memory (e.g., memory or storage for firmware, microcode, a basic-input-output (BIOS), and mass storage 1708 (e.g., hard drives, tape drives, flash storage, or other block devices) some or all of which can communicate with each other via an interlink 1730 (e.g., bus). The machine 1700 can further include a display unit 1710, an alphanumeric input device 1712 (e.g., a keyboard), and a user interface (UI), referred to as a UI navigation device 1714 (e.g., a mouse). In examples, the display unit 1710, the alphanumeric input device 1712 and the UI navigation device 1714 can be a touch screen display. The machine 1700 can additionally include a signal generation device 1718 (e.g., a speaker), a network interface device 1720, and one or more sensors 1716, such as a global positioning system (GPS) sensor, compass, accelerometer, or other sensor. The machine 1700 can include an output controller 1728, such as a serial (e.g., universal serial bus (USB), parallel, or other wired or wireless (e.g., infrared (IR), near field communication (NFC), etc.) connection to communicate or control one or more peripheral devices (e.g., a printer, card reader, etc.).
[0091] Registers of the hardware processor 1702, the main memory 1704, the static memory 1706, or the mass storage 1708 can be, or include, a machine-readable medium 1722 on which is stored one or more sets of data structures or instructions 1724 (e.g., software) embodying or utilized by any one or more of the techniques or functions described herein. The instructions 1724 can also reside, completely or partially, within any of registers of the hardware processor 1702, the main memory 1704, the static memory 1706, or the mass storage 1708 during execution thereof by the machine 1700. For example, one or any combination of the hardware processor 1702, the main memory 1704, the static memory 1706, or the mass storage 1708 can constitute the machine-readable medium 1722. While the machine-readable medium 1722 is illustrated 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 of the instructions 1724.
[0092] The term “machine-readable medium” can include any medium that is capable of storing, encoding, or carrying instructions for execution by the machine 1700 and that cause the machine 1700 to perform any one or more of the techniques ofDocket No. 5409.906W01 / / GAP24043-SUSF-WO 1 the present disclosure, or that is capable of storing, encoding or carrying data structures used by or associated with such instructions. Non-limiting machine-readable medium examples can include solid-state memories, optical media, magnetic media, and signals (e.g., radio frequency signals, other photon-based signals, sound signals, etc.). In an example, a non-transitory machine-readable medium comprises a machine-readable medium with a plurality of particles having invariant (e.g., rest) mass, and thus are compositions of matter. Accordingly, non-transitory machine-readable media are machine-readable media that do not include transitory 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.
[0093] In examples, information stored or otherwise provided on the machine- readable medium 1722 can be representative of the instructions 1724, such as instructions 1724 themselves or a format from which the instructions 1724 can be derived. This format from which the instructions 1724 can be derived can include source code, encoded instructions (e.g., in compressed or encrypted form), packaged instructions (e.g., split into multiple packages), or the like. The information representative of the instructions 1724 in the machine-readable medium 1722 can be processed by processing circuitry into the instructions to implement any of the operations discussed herein. For example, deriving the instructions 1724 from the information (e.g., processing by the processing circuitry) can include: compiling (e.g., from source code, object code, etc.), interpreting, loading, organizing (e.g., dynamically or statically linking), encoding, decoding, encrypting, unencrypting, packaging, unpackaging, or otherwise manipulating the information into the instructions 1724.
[0094] In examples, the derivation of the instructions 1724 can include assembly, compilation, or interpretation of the information (e.g., by the processing circuitry) to create the instructions 1724 from some intermediate or preprocessed format provided by the machine-readable medium 1722. The information, when provided in multiple parts, can be combined, unpacked, and modified to create the instructions 1724. For example, the information can be in multiple compressed source code packages (or object code, or binary executable code, etc.) on one or severalDocket No. 5409.906W01 / / GAP24043-SUSF-WO 1 remote servers. The source code packages can be encrypted when in transit over a network and decrypted, uncompressed, assembled (e.g., linked) if necessary, and compiled or interpreted (e.g., into a library, stand-alone executable etc.) at a local machine, and executed by the local machine.
[0095] The instructions 1724 can be further transmitted or received over a communications network 1726 using a transmission medium via the network interface device 1720 utilizing any one of a number of transfer protocols (e.g., frame relay, internet protocol (IP), transmission control protocol (TCP), user datagram protocol (UDP), hypertext transfer protocol (HTTP), etc.). Example communication networks can include a local area network (LAN), a wide area network (WAN), a packet data network (e.g., the Internet), LoRa / LoRaWAN, or satellite communication networks, mobile telephone networks (e.g., cellular networks such as those complying with 3G, 4G LTE / LTE-A, or 5G standards), Plain Old Telephone (POTS) networks, and wireless data networks (e.g., Institute of Electrical and Electronics Engineers (IEEE) 802.11 family of standards known as Wi-Fi®, IEEE 802.15.4 family of standards, peer-to-peer (P2P) networks, among others. In examples, the network interface device 1720 can include one or more physical jacks (e.g., Ethernet, coaxial, or phonejacks) or one or more antennas to connect to the communications network 1726. In examples, the network interface device 1720 can include a plurality of antennas to wirelessly communicate using one or more of single-input multiple-output (SIMO), multiple-input multiple-output (MIMO), or multiple-input single-output (MISO) techniques. The term “transmission medium” shall be taken to include any intangible medium that is capable of storing, encoding or carrying instructions for execution by the machine 1700, and includes digital or analog communications signals or other intangible medium to facilitate communication of such software. A transmission medium is a machine-readable medium.
[0096] The following, non-limiting examples, detail aspects of the present subject matter to solve the challenges and provide the benefits discussed herein, among others.
[0097] Example l is a fluid management system for an endoscope, comprising: an inflow tubing configured to direct a fluid toward a surgical site; an outflow tubing configured to draw outflow fluid away from the surgical site; a bypass line fluidically connecting the inflow tubing and the outflow tubing to direct the fluid from the inflow tubing to the outflow tubing and bypass the surgical site; and a valve operable toDocket No. 5409.906W01 / / GAP24043-SUSF-WO 1 permit fluid flow from the inflow tubing to the outflow tubing on condition that a pressure in one or more of the inflow tubing, the outflow tubing, or the surgical site is above a threshold value.
[0098] In Example 2, the subject matter of Example 1 optionally includes wherein the fluid management system is configured to be installed within a handle of the endoscope, the handle configured to be held by a clinician to control the endoscope, and wherein each of the inflow tubing and the outflow tubing are partially routed through the handle.
[0099] In Example 3, the subject matter of Example 2 optionally includes wherein the bypass line is located within the handle.
[0100] In Example 4, the subject matter of any one or more of Examples 1-3 optionally include wherein a diameter of the inflow tubing is less than a diameter of the bypass line and a diameter of the outflow tubing such that the fluid from the inflow tubing will flow through the bypass line and the outflow tubing as the valve permits the fluid to flow through the bypass line.
[0101] In Example 5, the subject matter of Example 4 optionally includes wherein the valve is a passive valve.
[0102] In Example 6, the subject matter of Example 5 optionally includes wherein the bypass line includes a taper such that a first diameter of the bypass line is smaller than a second diameter of the bypass line, and the first diameter of the bypass line is adjacent to the inflow tubing and the second diameter of the bypass line is adjacent to the outflow tubing.
[0103] In Example 7, the subject matter of Example 6 optionally includes wherein the valve is located within the bypass line, and wherein the valve comprises: a plug facing the inflow tubing, the plug configured to block the fluid from flowing through the bypass line; a permeable shelf configured to block the outflow fluid from flowing through the bypass line; and a biasing member connected to the plug and the permeable shelf, the biasing member configured to bias the plug toward the inflow tubing such that the plug blocks the bypass line, the biasing member including a stiffness defining the threshold value that permits the plug to move toward the outflow tubing to permit the fluid to flow through the bypass line.
[0104] In Example 8, the subject matter of any one or more of Examples 5-7 optionally include wherein the valve is located within the bypass line, and wherein the valve comprises: an elastic orifice operable between a closed position and an openDocket No. 5409.906W01 / / GAP24043-SUSF-WO 1 position, the elastic orifice biased toward the closed position, in the closed position the elastic orifice blocks the fluid from flowing through the bypass line.
[0105] In Example 9, the subject matter of Example 8 optionally includes wherein the elastic orifice comprises an elastic material, the elastic material defining the threshold value such that the elastic material deflects, to put the elastic orifice in the open position, as the elastic orifice is exposed to pressure over the threshold value to direct the fluid flow through the bypass line.
[0106] In Example 10, the subject matter of any one or more of Examples 4-9 optionally include wherein the valve is an active valve, and wherein the endoscope comprises: a pressure sensor configured to detect the pressure in one or more of the inflow tubing, the outflow tubing, or the surgical site.
[0107] In Example 11, the subject matter of Example 10 optionally includes wherein the valve is installed within the bypass line and wherein the valve comprises: a flexible member defining a lumen; and an actuator coupled to the flexible member, the actuator operable to adjust a diameter of the lumen based on the pressure in any of the inflow tubing, the outflow tubing, or the surgical site.
[0108] In Example 12, the subject matter of Example 11 optionally includes wherein the actuator is configured to reduce the diameter of the lumen in standard operating conditions to limit the fluid from flowing through the bypass line, and wherein the actuator is configured to increase the diameter of the lumen on condition that the detected pressure from the pressure sensor exceeds the threshold value.
[0109] In Example 13, the subject matter of any one or more of Examples 10- 12 optionally include wherein the valve is installed within the bypass line and wherein the valve comprises: a modulating orifice operable to define an orifice diameter; a lever connected to the modulating orifice such that the lever is operable to modulate the modulating orifice; and a linear actuator coupled to the lever and configured to actuate the lever to modulate the modulating orifice and adjust the orifice diameter.
[0110] In Example 14, the subject matter of Example 13 optionally includes wherein the linear actuator is configured to reduce the orifice diameter in standard operating conditions to limit fluid through the bypass line, and wherein the linear actuator is configured to increase the orifice diameter on condition that the detected pressure from the pressure sensor exceeds the threshold value.Docket No. 5409.906W01 / / GAP24043-SUSF-WO 1
[0111] In Example 15, the subject matter of any one or more of Examples 10- 14 optionally includes a control unit configured to receive pressure data from the pressure sensor and, based on the received pressure data, control the valve.
[0112] In Example 16, the subject matter of Example 15 optionally includes wherein the control unit is further configured to generate an alert when the pressure in one or more of the inflow tubing, the outflow tubing, or the surgical site exceeds the threshold value.
[0113] In Example 17, the subject matter of any one or more of Examples 1-16 optionally include wherein the valve operates between an open state and a closed state, and wherein the fluid management system comprises: a sensor configured to: detect a status of the valve, the status of the valve indicative of whether the valve is in the open state or the closed state; and transmit the status of the valve to a display accessible by a clinician.
[0114] In Example 18, the subject matter of any one or more of Examples 1-17 optionally include wherein the threshold value is adjustable based on a type of surgical procedure being performed.
[0115] In Example 19, the subject matter of any one or more of Examples 1-18 optionally include wherein the valve is further configured to automatically return to a closed position after the pressure falls below the threshold value.
[0116] In Example 20, the subject matter of any one or more of Examples 1-19 optionally include wherein the endoscope includes a ureteroscope and the surgical site is within a urinary tract.
[0117] Example 21 is a fluid management system for an endoscope, comprising: an outflow tubing configured to direct outflow fluid away from a surgical site; a suction pump fluidically connected to the outflow tubing and configured to draw the outflow fluid away from the surgical site; and a pressure-regulating reservoir fluidically connected to the outflow tubing, the pressure-regulating reservoir configured to expand in response to a pressure within the outflow tubing being above a threshold value.
[0118] In Example 22, the subject matter of Example 21 optionally includes wherein the fluid management system is configured to be installed within a handle of the endoscope, the handle configured to be held by a clinician to control the endoscope, and wherein the outflow tubing is routed through the handle.Docket No. 5409.906W01 / / GAP24043-SUSF-WO 1
[0119] In Example 23, the subject matter of any one or more of Examples 21- 22 optionally include wherein the pressure-regulating reservoir is configured to expand to remove outflow fluid from the outflow tubing and decrease the pressure within the outflow tubing.
[0120] In Example 24, the subject matter of Example 23 optionally includes wherein the pressure-regulating reservoir includes an elastic material such that the pressure-regulating reservoir deflates upon the pressure within the outflow tubing being below the threshold value.
[0121] In Example 25, the subject matter of Example 24 optionally includes a valve disposed between the outflow tubing and the pressure-regulating reservoir, the valve configured to close to block fluid flow into the pressure-regulating reservoir as the pressure in the outflow tubing is below the threshold value and open to permit fluid flow into the pressure-regulating reservoir as the pressure in the outflow tubing is above the threshold value.
[0122] In Example 26, the subject matter of any one or more of Examples 24-25 optionally include a pressure relief valve fluidically connected to the pressureregulating reservoir, the pressure relief valve includes a bias toward a closed position to maintain outflow fluid within the pressure-regulating reservoir, the pressure relief valve configured to open upon a pressure within the pressure-regulating reservoir being above a full threshold value, the full threshold value indicative that the pressureregulating reservoir is full.
[0123] In Example 27, the subject matter of any one or more of Examples 24-26 optionally include a valve disposed between the outflow tubing and the pressureregulating reservoir, the valve configured to close to block outflow fluid flow into the pressure-regulating reservoir as the pressure in the outflow tubing is below the threshold value and open to permit fluid flow into the pressure-regulating reservoir as the pressure in the outflow tubing is above the threshold value; and a pressure relief valve fluidically connected to the pressure-regulating reservoir, the pressure relief valve includes a bias toward a closed position to maintain outflow fluid within the pressure-regulating reservoir, the pressure relief valve configured to open upon a pressure within the pressure-regulating reservoir being above a full threshold value, the full threshold value indicative that the pressure-regulating reservoir is full.
[0124] In Example 28, the subject matter of any one or more of Examples 24-27 optionally include an inflow tubing configured to direct a fluid to the surgical site;Docket No. 5409.906W01 / / GAP24043-SUSF-WO 1 and an inflow pump fluidically connected to the inflow tubing and configured to pump the fluid to the surgical site.
[0125] In Example 29, the subject matter of Example 28 optionally includes a sensor configured to: detect the pressure within the inflow tubing; transmit a signal to the inflow pump to decrease a rate of the fluid supplied to the surgical site; and transmit a signal to the suction pump to increase a rate of outflow fluid removal.
[0126] In Example 30, the subject matter of any one or more of Examples 28- 29 optionally include an inflow pressure-regulating reservoir connected to the inflow tubing, the inflow pressure-regulating reservoir configured to expand in response to an inflow pressure within the inflow tubing being above an inflow threshold value.
[0127] In Example 31, the subject matter of Example 30 optionally includes wherein the inflow threshold value is greater than the threshold value such that the pressure-regulating reservoir expands before the inflow pressure-regulating reservoir.
[0128] In Example 32, the subject matter of any one or more of Examples 30-31 optionally include a valve disposed between the inflow tubing and the inflow pressure-regulating reservoir, the valve configured to close to block the fluid from flowing into the inflow pressure-regulating reservoir as the pressure in the inflow tubing is below the inflow threshold value and open to permit the fluid to flow into the inflow pressure-regulating reservoir as the inflow pressure in the inflow tubing is above the inflow threshold value; and a pressure relief valve fluidically connected to the inflow pressure-regulating reservoir, the pressure relief valve includes a bias toward a closed position to maintain the fluid within the inflow pressure-regulating reservoir, the pressure relief valve configured to open upon the inflow pressure within the inflow pressure-regulating reservoir being above a full inflow threshold value, the full inflow threshold value indicative that the inflow pressure-regulating reservoir is full.
[0129] In Example 33, the subject matter of any one or more of Examples 21-32 optionally include wherein the suction pump is configured to operate at variable speeds to adjust a rate of outflow fluid removal based on a detected pressure within the outflow tubing.
[0130] In Example 34, the subject matter of any one or more of Examples 21-33 optionally include a sensor configured to: detect the pressure within the outflow tubing; and provide a signal to the suction pump to adjust a rate of outflow fluid removal.Docket No. 5409.906W01 / / GAP24043-SUSF-WO 1
[0131] In Example 35, the subject matter of any one or more of Examples 21-34 optionally include wherein the pressure-regulating reservoir is further configured to provide a visual indication of expansion of the pressure-regulating reservoir.
[0132] In Example 36, the subject matter of any one or more of Examples 21-35 optionally include wherein the pressure-regulating reservoir is further configured to automatically deflate when the fluid management system is powered off, ensuring that the pressure-regulating reservoir is empty prior to a subsequent use.
[0133] In Example 37, the subject matter of any one or more of Examples 21-36 optionally include wherein the pressure-regulating reservoir is configured to deflate, in response to the pressure within the outflow tubing being below the threshold value.
[0134] In Example 38, the subject matter of any one or more of Examples 21-37 optionally include wherein the pressure-regulating reservoir is configured to operate between a deflated state and an expanded state, and wherein the fluid management system comprises: a sensor configured to detect when the pressure-regulating reservoir is in the expanded state; and generate an expanded signal in response to the pressureregulating reservoir being in the expanded state.
[0135] In Example 39, the subject matter of Example 38 optionally includes a controller including processing circuitry; and memory coupled to the controller, the memory including instructions that, when executed by the processing circuitry, are configured to cause the processing circuitry to: receive the expanded signal; and transmit a controlling signal to decrease a pumping rate of an irrigation pump, the irrigation pump configured to provide irrigation fluid to the surgical site.
[0136] In Example 40, the subject matter of Example 39 optionally includes wherein the instructions configure the processing circuitry to: generate, in response to receiving the expanded signal, an expanded alert to indicate that the pressureregulating reservoir is in the expanded state.
[0137] Example 41 is a fluid management system for an endoscope, comprising: an inflow tubing configured to direct fluid toward a surgical site; a irrigation pump fluidically connected to the inflow tubing and configured to provide fluid to the surgical site; and a pressure-regulating reservoir fluidically connected to the inflow tubing, the pressure-regulating reservoir configured to expand in response to a pressure within the inflow tubing being above a threshold value.
[0138] In Example 42, the subject matter of Example 41 optionally includes wherein the fluid management system is configured to be installed within a handle ofDocket No. 5409.906W01 / / GAP24043-SUSF-WO 1 the endoscope, the handle configured to be held by a clinician to control the endoscope, and wherein the inflow tubing is partially routed through the handle.
[0139] In Example 43, the subject matter of any one or more of Examples 41- 42 optionally include wherein the pressure-regulating reservoir is configured to expand to remove fluid from the inflow tubing and decrease the pressure within the inflow tubing.
[0140] In Example 44, the subject matter of Example 43 optionally includes wherein the pressure-regulating reservoir includes an elastic material such that the pressure-regulating reservoir deflates upon the pressure within the inflow tubing being below the threshold value.
[0141] In Example 45, the subject matter of Example 44 optionally includes a valve disposed between the inflow tubing and the pressure-regulating reservoir, the valve configured to close to block fluid flow into the pressure-regulating reservoir as the pressure in the inflow tubing is below the threshold value and open to permit fluid flow into the pressure-regulating reservoir as the pressure in the inflow tubing is above the threshold value.
[0142] In Example 46, the subject matter of any one or more of Examples 44-45 optionally include a pressure relief valve fluidically connected to the pressureregulating reservoir, the pressure relief valve includes a bias toward a closed position to maintain fluid within the pressure-regulating reservoir, the pressure relief valve configured to open upon a pressure within the pressure-regulating reservoir being above a full threshold value, the full threshold value indicative that the pressureregulating reservoir is full.
[0143] In Example 47, the subject matter of any one or more of Examples 44-46 optionally include an outflow tubing configured to draw outflow fluid away from the surgical site; and a suction pump fluidically connected to the outflow tubing and configured to pump the outflow fluid from the surgical site.
[0144] In Example 48, the subject matter of Example 47 optionally includes a sensor configured to: detect the pressure within the inflow tubing; transmit a signal to the inflow pump to decrease a rate of the fluid supplied to the surgical site; and transmit a signal to the suction pump to increase a rate of outflow fluid removal.
[0145] Example 49 includes a method, device, system, or apparatus including any element of any of examples 1-47.Docket No. 5409.906W01 / / GAP24043-SUSF-WO 1
[0146] The above-detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific examples that can be practiced. These embodiments are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.
[0147] All publications, patents, and patent documents referred to in this document are incorporated by reference herein in their entirety, as though individually incorporated by reference. In the event of inconsistent usages between this document and those documents so incorporated by reference, the usage in the incorporated reference(s) should be considered supplementary to that of this document; for irreconcilable inconsistencies, the usage in this document controls.
[0148] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In the appended claims, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.
[0149] When the term “about” is used in conjunction with a numerical range, it modifies that range by extending the boundaries above and below the numerical values set forth. In general, the term “about” is used herein to modify a numerical value above and below the stated value by a variance of 10%. In one aspect, the term “about” means plus or minus 10% of the numerical value of the number with which it is being used. Therefore, about 50% means in the range of 45%-55%. NumericalDocket No. 5409.906W01 / / GAP24043-SUSF-WO 1 ranges recited herein by endpoints include all numbers and fractions subsumed 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 recited herein by endpoints include subranges subsumed within that range (e.g., 1 to 5 includes 1-1.5, 1.5-2, 2-2.75, 2.75-3, 3-3.90, 3.90-4, 4-4.24, 4.24-5, 2-5, 3-5, 1-4, and 2-4). It is also to be understood that all numbers and fractions thereof are presumed to be modified by the term “about.”
[0150] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) can be used in combination with each other. Other examples can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is to allow the reader to quickly ascertain the nature of the technical disclosure and is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features can be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter can lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate embodiment. The scope of the examples should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.
[0151] The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after one or more uses. Reconditioning can include a combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and / or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those of ordinary skill in the art will appreciate that the reconditioning of a device can utilize a variety of different techniques for disassembly, cleaning / replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.Docket No. 5409.906W01 / / GAP24043-SUSF-WO 1
[0152] Preferably, the invention described herein will be processed before surgery. First a new or used instrument is obtained and, if necessary, cleaned. The instrument can then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK® bag. The container and instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or higher energy electrons. The radiation kills bacteria on the instrument and in the container. The sterilized instrument can then be stored in the sterile container. The sealed container keeps the instrument sterile until it is opened in the medical facility. The device can also be sterilized using any other technique known in the art, including but limited to beta or gamma radiation, ethylene oxide, or steam.
Claims
Docket No. 5409.906W01 / / GAP24043-SUSF-WO 1CLAIMSWhat is claimed is:
1. A fluid management system for an endoscope, comprising: an outflow tubing configured to direct outflow fluid away from a surgical site; a suction pump fluidically connected to the outflow tubing and configured to draw the outflow fluid away from the surgical site; and a pressure-regulating reservoir fluidically connected to the outflow tubing, the pressure-regulating reservoir configured to expand in response to a pressure within the outflow tubing.
2. The fluid management system of claim 1, wherein the pressure-regulating reservoir is configured to expand and retract in response to the pressure within the outflow tubing relative to a threshold value.
3. The fluid management system of any of claims 1-2, wherein the fluid management system is configured to be installed within a handle of the endoscope, the handle configured to be held by a clinician to control the endoscope, and wherein the outflow tubing is at least partially routed through the handle.
4. The fluid management system of any of claims 2-3, wherein the pressureregulating reservoir is configured to expand to remove outflow fluid from the outflow tubing and decrease the pressure within the outflow tubing.
5. The fluid management system of claim 4, wherein the pressure-regulating reservoir includes an elastic material such that the pressure-regulating reservoir deflates upon the pressure within the outflow tubing being below the threshold value.
6. The fluid management system of claim 5, comprising: a valve disposed between the outflow tubing and the pressure-regulating reservoir, the valve configured to block fluid flow into the pressureregulating reservoir as the pressure in the outflow tubing is below the threshold value and permit fluid flow into the pressure-regulating reservoir as the pressure in the outflow tubing is above the threshold value.Docket No. 5409.906W01 / / GAP24043-SUSF-WO 17. The fluid management system of any of claims 5-6, comprising: a pressure relief valve fluidically connected to the pressure-regulating reservoir, the pressure relief valve includes a bias toward a closed position to maintain outflow fluid within the pressure-regulating reservoir, the pressure relief valve configured to open upon a pressure within the pressure-regulating reservoir being above a full threshold value, the full threshold value indicative that the pressure-regulating reservoir is full.
8. The fluid management system of any of claims 5-7, comprising: a valve disposed between the outflow tubing and the pressure-regulating reservoir, the valve configured to block outflow fluid flow into the pressure-regulating reservoir as the pressure in the outflow tubing is below the threshold value and permit fluid flow into the pressureregulating reservoir as the pressure in the outflow tubing is above the threshold value; and a pressure relief valve fluidically connected to the pressure-regulating reservoir, the pressure relief valve includes a bias toward a closed position to maintain outflow fluid within the pressure-regulating reservoir, the pressure relief valve configured to open upon a pressure within the pressure-regulating reservoir being above a full threshold value, the full threshold value indicative that the pressure-regulating reservoir is full.
9. The fluid management system of any of claims 5-8, comprising: an inflow tubing configured to direct a fluid to the surgical site; and an inflow pump fluidically connected to the inflow tubing and configured to pump the fluid to the surgical site.
10. The fluid management system of claim 9, further comprising: a sensor configured to: detect the pressure within the inflow tubing; transmit a signal to the inflow pump to decrease a rate of the fluid supplied to the surgical site; andDocket No. 5409.906W01 / / GAP24043-SUSF-WO 1 transmit a signal to the suction pump to increase a rate of outflow fluid removal.
11. The fluid management system of any of claims 9-10, comprising: an inflow pressure-regulating reservoir connected to the inflow tubing, the inflow pressure-regulating reservoir configured to expand in response to an inflow pressure within the inflow tubing being above an inflow threshold value.
12. The fluid management system of claim 11, wherein the inflow threshold value is greater than the threshold value such that the pressure-regulating reservoir expands before the inflow pressure-regulating reservoir.
13. The fluid management system of any of claims 11-12, comprising: a valve disposed between the inflow tubing and the inflow pressure-regulating reservoir, the valve configured to block the fluid from flowing into the inflow pressure-regulating reservoir as the pressure in the inflow tubing is below the inflow threshold value and permit the fluid to flow into the inflow pressure-regulating reservoir as the inflow pressure in the inflow tubing is above the inflow threshold value; and a pressure relief valve fluidically connected to the inflow pressure-regulating reservoir, the pressure relief valve includes a bias toward a closed position to maintain the fluid within the inflow pressure-regulating reservoir, the pressure relief valve configured to open upon the inflow pressure within the inflow pressure-regulating reservoir being above a full inflow threshold value, the full inflow threshold value indicative that the inflow pressure-regulating reservoir is full.
14. The fluid management system of any of claims 1-13, wherein the suction pump is configured to operate at variable speeds to adjust a rate of outflow fluid removal based on a detected pressure within the outflow tubing.
15. The fluid management system of any of claims 1-14, further comprising: a sensor configured to:Docket No. 5409.906W01 / / GAP24043-SUSF-WO 1 detect the pressure within the outflow tubing; and provide a signal to the suction pump to adjust a rate of outflow fluid removal.
16. The fluid management system of any of claims 1-15, wherein the pressureregulating reservoir is further configured to provide a visual indication of expansion of the pressure-regulating reservoir.
17. The fluid management system of any of claims 1-16, wherein the pressureregulating reservoir is further configured to automatically deflate when the fluid management system is powered off, to empty the pressure-regulating reservoir before subsequent use.
18. The fluid management system of any of claims 2-17, wherein the pressureregulating reservoir is configured to deflate, in response to the pressure within the outflow tubing being below the threshold value.
19. The fluid management system of any of claims 1-18, wherein the pressureregulating reservoir is configured to operate between a deflated state and an expanded state, and wherein the fluid management system comprises: a sensor configured to detect when the pressure-regulating reservoir is in the expanded state; and generate an expanded signal in response to the pressure-regulating reservoir being in the expanded state.
20. The fluid management system of claim 19, comprising: a controller including processing circuitry; and memory coupled to the controller, the memory including instructions that, when executed by the processing circuitry, are configured to cause the processing circuitry to: receive the expanded signal; and transmit a controlling signal to decrease a pumping rate of an irrigation pump, the irrigation pump configured to provide irrigation fluid to the surgical site.Docket No. 5409.906W01 / / GAP24043-SUSF-WO 121. The fluid management system of claim 20, wherein the instructions configure the processing circuitry to: generate, in response to receiving the expanded signal, an expanded alert to indicate that the pressure-regulating reservoir is in the expanded state.
22. A fluid management system for an endoscope, comprising: an inflow tubing configured to direct fluid toward a surgical site; an irrigation pump fluidically connected to the inflow tubing and configured to provide fluid to the surgical site; and a pressure-regulating reservoir fluidically connected to the inflow tubing, the pressure-regulating reservoir configured to expand in response to a pressure within the inflow tubing being above a threshold value.
23. The fluid management system of claim 22, wherein the fluid management system is configured to be installed within a handle of the endoscope, the handle configured to be held by a clinician to control the endoscope, and wherein the inflow tubing is at least partially routed through the handle.
24. The fluid management system of any of claims 22-23, wherein the pressureregulating reservoir is configured to expand to remove fluid from the inflow tubing and decrease the pressure within the inflow tubing.
25. The fluid management system of claim 24, wherein the pressure-regulating reservoir includes an elastic material such that the pressure-regulating reservoir deflates upon the pressure within the inflow tubing being below the threshold value.
26. The fluid management system of claim 25, comprising: a valve disposed between the inflow tubing and the pressure-regulating reservoir, the valve configured to block fluid flow into the pressureregulating reservoir as the pressure in the inflow tubing is below the threshold value and permit fluid flow into the pressure-regulating reservoir as the pressure in the inflow tubing is above the threshold value.Docket No. 5409.906W01 / / GAP24043-SUSF-WO 127. The fluid management system of any of claims 25-26, comprising: a pressure relief valve fluidically connected to the pressure-regulating reservoir, the pressure relief valve includes a bias toward a closed position to maintain fluid within the pressure-regulating reservoir, the pressure relief valve configured to open upon a pressure within the pressureregulating reservoir being above a full threshold value, the full threshold value indicative that the pressure-regulating reservoir is full.
28. The fluid management system of any of claims 25-27, comprising: an outflow tubing configured to draw outflow fluid away from the surgical site; and a suction pump fluidically connected to the outflow tubing and configured to pump the outflow fluid from the surgical site.
29. The fluid management system of claim 28, further comprising: a sensor configured to: detect the pressure within the inflow tubing; transmit a signal to the irrigation pump to decrease a rate of the fluid supplied to the surgical site; and transmit a signal to the suction pump to increase a rate of outflow fluid removal.
30. A method of managing pressure during an endoscopic procedure, the method comprising: expanding, a pressure-regulating reservoir connected to an outflow tubing, in response to a pressure within the outflow tubing; and retracting, the pressure-regulating reservoir connected to the outflow tubing, in response to the pressure within the outflow tubing.
31. The method of claim 30, wherein expanding the pressure-regulating reservoir decreases the pressure within the outflow tubing.Docket No. 5409.906W01 / / GAP24043-SUSF-WO 132. The method of any of claims 30-31, wherein retracting the pressureregulating reservoir empties an outflow fluid from the pressure-regulating reservoir.
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