Engagable actuation mechanism
The engageable actuation mechanism addresses the challenge of controlling ancillary devices during endoscope procedures by using signal-controlled feeding machines, improving procedural efficiency and precision.
Patent Information
- Application Number
- PCT/US2024/045131
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-09-11
- Filing Date
- 2024-09-04
- Publication Date
- 2025-03-20
AI Technical Summary
Conventional endoscopes with steering systems require constant use of one hand, and sometimes both hands, which limits a medical professional's ability to control ancillary devices during medical procedures.
An engageable actuation mechanism is introduced, which includes an elongated body with first and second engageable assemblies. These assemblies generate signals that control the feeding machine to advance or retract ancillary devices within the endoscope's working channel, allowing for independent control of ancillary devices while steering the endoscope.
The engageable actuation mechanism enables medical professionals to control ancillary devices without compromising the steering of the endoscope, thereby enhancing procedural efficiency and precision.
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Figure US2024045131_20032025_PF_FP_ABST
Abstract
Description
ENGAGABLE ACTUATION MECHANISMCLAIM OF PRIORITY
[0001] This patent application claims the benefit of priority, under 35 U.S.C. Section 1 19(e), to David Leak U.S. Patent Application Serial Number 63 / 581 ,900, entitled “ENGAGABLE ACTUATION MECHANISM,” filed on September 11 , 2023 (Attorney Docket No. 5409.852PRV), which is hereby incorporated by reference herein in its entirety.TECHNICAL FIELD
[0002] Examples described herein generally relate to medical devices and, more specifically, to engageable actuation mechanisms for medical devices.BACKGROUND
[0003] Conventional endoscopes can be used in a variety of clinical procedures, including, for example, illuminating, imaging, detecting and diagnosing one or more disease states, providing fluid delivery (e.g., saline or other preparations via a fluid channel) toward an anatomical region, providing passage (e.g., via a working channel) of one or more therapeutic devices for sampling or treating an anatomical region, providing suction passageways for collecting fluids (e.g., saline or other preparations), and the like. Such anatomical regions can include the gastrointestinal tract (e.g., esophagus, stomach, duodenum, pancreaticobiliary duct, intestines, colon, and the like), renal area (e.g., kidney(s), ureter, bladder, urethra), other internal organs (e.g., reproductive systems, sinus cavities, submucosal regions, respiratory tract), and the like.SUBSTITUTE SHEET (RULE 26)SUMMARY
[0004] Medical devices, such as, for example, endoscopes may require delivery and usage of ancillary devices within the working channel of the endoscope. However, endoscopes with a steering system typically require constant use of one hand, and in some cases, simultaneous use of both hands, which can limit a medical professional’s ability to control the ancillary devices while steeringthe medical device during the medical procedure. Therefore, the inventors of the present disclosure appreciate the need for a device that can help control the ancillary device while the endoscopist is steeringthe endoscope.
[0005] In examples, a medical instrument for insertion into a patient can include an elongated member, a handle section, a feeding machine, and an actuation device. The elongated member can be insertable into the patient. The elongated member can extend between a proximal portion and a distal portion. The elongated member can define a lumen extendingfrom the proximal portion to the distal portion. The handle section can extend between a proximal end and a distal end. The distal end can be connected to the proximal portion of the elongated member. The handle section can include an accessory port to receive an ancillary device. The accessory port can be connected to the lumen. The feeding machine can be operable to control the insertion and retraction of the ancillary device within the lumen. The actuation assembly can be operable to send a first signal and a second signal to the feeding machine. The first signal can advance the ancillary device into the accessory port, and the second signal can retract the ancillary device from the accessory port.
[0006] In examples, an actuation assembly can be configured to be attached to a medical instrument and can include an elongated body, a first engageable assembly, and a second engageable assembly. The elongated body can include a first end portion and a second end portion. The second end portion can be opposite the first end portion. The first engageable assembly can be disposed adjacent to the first end portion. The first engageable assembly can be operable to generate a first signal. The second2SUBSTITUTE SHEET (RULE 26)engageable assembly can be disposed adjacent to the second end portion. The second engageable assembly can be operable to generate a second signal. The first signal and the second signal can be transmitted to the medical instrument to control one or more parameters of the medical instrument.
[0007] In examples, a method for reprocessing an endoscope can include obtaining an endoscope; sterilizing the endoscope; and storingthe endoscope.BRIEF DESCRIPTION OF THE DRAWINGS
[0008] 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.
[0009] FIG. 1 illustrates a schematic diagram of an example of an endoscopic system.
[0010] FIG. 2 illustrates a schematic diagram of an example of an imaging and control system of an endoscopic system.
[0011] FIG. 3 is a side view of an example of an endoscope including an engageable actuation mechanism.
[0012] FIG. 4 is a front view of an example of an engageable actuator mechanism.
[0013] FIG. 5 is a perspective view of an example of an engageable actuation mechanism being attached to an example endoscope.
[0014] FIG. 6 is a perspective view of an example of an engageable actuation mechanism attached to an example endoscope.
[0015] FIG. 7 is a front view of an example of an engageable actuator mechanism.
[0016] FIG. 8 is a side view of an example endoscope with an example engageable actuation mechanism in a first position.
[0017] FIG. 9 is a side view of an example endoscope with an example engageable actuation mechanism in a second position.3SUBSTITUTE SHEET (RULE 26)
[0018] FIG. 10 is a side view of an example endoscope with an example engageable actuation mechanism in a third position.
[0019] FIG. 11 is a schematic diagram of an example of an engageable actuation mechanism.
[0020] FIG. 12 is a perspective view of an example of an engageable actuation mechanism installed on an example endoscope.
[0021] FIG. 13 is a schematic diagram of an example of an endoscopic system includingtwo feed machines.
[0022] FIG. 14 is a schematic diagram of a method of reprocessing an example endoscope.
[0023] FIG. 15 illustrates a block diagram of an example machine upon which any one or more of the techniques (e.g., methodologies) discussed herein may perform.
[0024] FIG. 16 illustrates a schematic diagram of an exemplary computer-based clinical decision support system (CDSS).DETAILED DESCRIPTION
[0025] Endoscopic systems can generally be described as flexible endoscopes containing illumination and imaging channels as well as working channels. The working channels can provide access for additional instruments providing functionality, such as, for example, irrigation, suction, grasping, energy delivery, cutting or resecting, or the like.Endoscopes can be equipped with steering actuators capable of providing both angulation (i.e., up and down movement) and rotation (i.e., about a longitudinal axis of the elongated member). Steering actuators can utilize either an angulation lever or dual steering knobs.
[0026] FIG. 1 is a schematic diagram of an endoscopy system 100 that can include a control system 102 and an endobronchial ultrasound sampling arrangement including an endoscope 104 and a medical device 108 that is attachable to the endoscope 104 and which includes a distal end 110 that extends from the distal end of the endoscope 104 via a distal working channel port (e.g., working channel port 112). The system of FIG. 14SUBSTITUTE SHEET (RULE 26)is an illustrative example of an endoscopy system suitable for use with the systems, devices, and methods described herein.
[0027] The endoscope 104 can be insertable into an anatomical region for imaging or attachment to (e.g., via tethering) one or more sampling devices for biopsies or therapeutic devices for treating a disease state associated with the anatomical region. The endoscope 104 can interface or connect to the control system 102. The endoscope 104 is described in the present example as a bronchoscope, though other types of endoscopes are contemplated for use with the features and teachings of the present disclosure. The control system 102 can include a control unit 114, a display unit 116, an input unit 118, a light source 120, a fluid source 122, and a suction pump 124.
[0028] The control system 102 can include various ports for coupling with the endoscopy system 100. For example, the control unit 114 can include a data input / output port for receiving data from and communicating data to the endoscope 104. The light source 120 can include an output port for transmitting light to the endoscope 104, such as via a fiber optic link. The fluid source 122 can include a port for transmitting fluid to the endoscope 1 O4. The fluid source 122 can include, for example, a pump and a fluid tank or can be connected to an external tank, vessel, or storage unit. The suction pump 124 can include a port to draw a vacuum from the endoscope 104 to generate suction, such as for withdrawing fluid from the anatomical region into which the endoscope 104 is inserted. The display unit 116 and the input unit 118 can be used by an operator of the endoscopy system 100 to control functions of the endoscopy system 100 and viewthe output of the endoscope 104. The control unit 114 can also generate signals or other outputs from treating the anatomical region into which the endoscope 104 is inserted. In examples, the control unit 114 can generate electrical output, acoustic output, fluid output, or the like for treating the anatomical region with, for example, cauterizing, cutting, freezing, or the like.5SUBSTITUTE SHEET (RULE 26)
[0029] The endoscope 104 can include an insertion section 126, a functional section 128, and a handle section 130, which can be coupled to a cable section 132 and a coupler section 134. The insertion section 126 can extend distally from the handle section 130, and the cable section 132 can extend proximally from the handle section 130. The insertion section 126 can be elongated and include a bending section and a distal end to which the functional section 128 can be attached. The bending section can be controllable (e.g., by a steering control 136 on the handle section 130) to maneuver the distal end through tortuous anatomical passageways (e.g., stomach, duodenum, kidney, ureter, trachea, lungs, or the like). The insertion section 126 can also include one or more working channels (e.g., an internal lumen) that can be elongated and can support the insertion of one or more therapeutic tools of the functional section 128, such as a bronchoscope. The working channel can extend between the handle section 130 and the functional section 128. Additional functionalities, such as fluid passages, guide wires, and pull wires, can also be provided by the insertion section 126 (e.g., via suction or irrigation passageways, or the like).
[0030] A coupler section 134 can be connected to the control unit 114 to connect to the endoscope 104 to multiple features of the control unit 114, such as the input unit 118, the light source 120, the fluid source 122, and the suction pump 124.
[0031] The handle section 130 can include the steering control 136 and the port 138. The steering control 136 can be a knob, lever, or other actuation mechanism or the like, which can be used to navigate the endoscope 104 within the patient. The steering control 136 can be connected to a pull wire or other actuation mechanisms, extending through the insertion section 126. The port 138, as well as other ports, such as a port 140 can be configured to couple various electrical cables, guide wires, auxiliary scopes, tissue collection devices, fluid tubes, and the like to the handle section 130, such as for coupling with the insertion section 126. The examples shown in FIG. 1 and FIG. 2 are examples of endoscopes 104.6SUBSTITUTE SHEET (RULE 26)
[0032] According to examples, the control system 102 can be provided on a mobile platform (e.g., a cart 142) with shelves for housingthe light source 120, the suction pump 124, an image processing unit 202 (FIG. 2), or the like. Alternatively, components of the control system 102, shown in FIG. 1 and FIG. 2, can be provided directly on the endoscope 104 to make the endoscope “self-contained.”
[0033] The functional section 128 can include components for treating and diagnosing the anatomy of a patient. The functional section 128 can include an imaging device 144 (e.g., a complementary metal oxide semiconductor (CMOS) based, Chip-on-the-Tip image sensors), an illumination device 146 (e.g., a light emitting diode), and the working channel port 112 at a distal face of the functional section 128.
[0034] As shown in FIG. 1 , a medical device 108 can extend from the working channel port 112 at the distal face of the functional section 128 of the medical device 108. The medical device 108 can be configured to be attached to the port 138 such that the medical device 108 extends through a working channel (e.g., the extending through the insertion section 126 to the working channel port 112) of the endoscope 104 and out the distal end of the endoscope 104. The medical device 108 can include an actuator 148 for advancing or retracting the insertion section 126 within the working channel so as to control how far distally from the working channel port 112 the distal end of the medical device 108 extends, an instrument actuator 150 (e.g., for actuating a biopsy needle from a side exit port of the medical device 108), and a distal end 110. The instrument actuator 150 can be configured to extend the medical device 108 beyond a distal end of the endoscope 104, such as to navigate the medical device 108 to the target area within the patient. The instrument actuator 150 can slide along a housing 152 of the medical device 108. The housing 152 can include indicia, which can indicate an amount of extension of the medical device 108 beyond a distal end of the endoscope 104 (e.g., beyond the working channel port 112). The instrument actuator 150 can be configured to extend an instrument from the medical device 108 to obtain a tissue sample from7SUBSTITUTE SHEET (RULE 26)the patient. A distal end 110 of the medical device 108 can include a transducer (or other imaging device) and a side exit port located proximal from the transducer for directing an instrument configured to obtain a tissue sample from the patient into the field of view of the transducer. The medical device 108 will be discussed in more detail herein.
[0035] FIG. 2 is a schematic diagram of the endoscopy system 100 of FIG. 1 includingthe control system 102 and the endobronchial ultrasound arrangement, which includes an endoscope 104 and a medical device 108 extendable via a distal working channel port of the endoscope 104. FIG. 2 schematically illustrates components of the control system 102 coupled to the endoscope 104. The control system 102 can include the control unit 114, which can include or be coupled to an image processing unit 202, a treatment generator 204, and a drive unit 206, as well as the light source 120, the input unit 118, and the display unit 116. The control unit 114 can include or can be in communication with, an endoscope, a surgical instrument, and an endoscopy system, which can include a device configured to engage tissue and collect and store a portion of that tissue and through which imaging equipment (e.g., a camera) can view target tissue via the inclusion of optically enhanced materials and components. The control unit 114 can be configured to activate a camera to view target tissues distal of the endoscopy system. Likewise, the control unit 114 can be configured to activate the light source 120 to shine a light on the surgical instrument, which can include select components configured to reflect light in a particular manner, such as tissue cutters being enhanced with reflective particles.
[0036] The coupler section 134 can be connected to the control unit 114 to connect to the endoscope 104 to multiple features of the control unit 114, such as the image processing unit 202, the treatment generator 204, or the like. In examples, the port 138 can be used to insert another instrument or device, such as a daughter scope or auxiliary scope, or a sampling needle, biopsy needle, ablation instrument, scalpel, orthe like, into the endoscope 104. Such instruments and devices can be independently8SUBSTITUTE SHEET (RULE 26)connected to the control unit 114 via the cable section 132. In examples, the port 140 can be used to connect the coupler section 134 to various inputs and outputs, such as video, air, light and electric.
[0037] The image processing unit 202, the ultrasound image processing unit 208, and the light source 120 can each interface with the endoscope 104 (e.g., at the functional section 128) or the medical device 108 by wired or wireless electrical connections. The control system 102 can accordingly illuminate an anatomical region, collect signals representing the anatomical region, process signals representing the anatomical region, and display images representing the anatomical region on the display unit 116. The ultrasound image processing unit 208 can be configured to receive ultrasonic signals from either of the endoscope 104 orthe medical device 108, which can be converted into ultrasonic images and transmitted to the display unit 116 or any other component of the endoscopy system 100. The control system 102 can include the light source 120 to illuminate the anatomical region using light of a desired spectrum (e.g., broadband white light, narrow-band imaging using electromagnetic wavelengths, and the like). The control system 102 can connect (e.g., via an endoscope connector) to the endoscope 104 for signal transmission (e.g., light output from the light source, video signals from the imaging system in the distal end, diagnostic and sensor signals from a diagnostic device, and the like).
[0038] The fluid source 122 (shown in FIG. 1) can be in communication with the control unit 114 and can include one or more sources of air, saline, or other fluids, as well as associated fluid pathways (e.g., air channels, irrigation channels, suction channels, and the like) and connectors (barb fittings, fluid seals, valves, and the like). The control system 102 can also include a drive unit 206, which can include a motorized drive for advancing a distal section of endoscope 104.
[0039] As shown in FIGS. 1 and 2, the endoscopy system 100 can include a device 322 coupled to or attached to steering control 136. The device 322 can be configured to transmit one or more signals so that the endoscopist can control one or more components, devices, or parameters9SUBSTITUTE SHEET (RULE 26)of the endoscopic device with the same hand they’re using to navigate the endoscope within the patient. The device 322 will be discussed in more detail with reference to FIGS. 3-15.
[0040] FIG. 3 is a side view of an example of an endoscope 300 including an engageable actuation mechanism. The endoscope 300 can be used to complete medical procedures throughout the body of a patient. The endoscope 300 can include a handle 302, an ancillary device 318, a flexible member 340, and a feeding machine 350.
[0041] The handle 302 (e.g., the handle section 130 of FIG. 1 ) can be configured to fit within the hand of the endoscopist. The handle 302 can extend between a proximal end 304 and a distal end 306. The handle 302 can be where an endoscopist would grip the endoscope 300 to control the endoscope 300 duringthe endoscopic procedure. As such, the handle 302 can include a curved profile that fits ergonomically within the hand of the endoscopist. The handle 302 can include plastic, rubber, any other polymer, any composite or combination thereof, or the like. The handle 302 can include one or more working channels or working lumens that can be connected to the flexible member 340. The handle 302 can include an irrigation port 308, a suction port 310, an accessory port 312, and steering mechanism 320.
[0042] The irrigation port 308 (e.g., the port 138 or the port 140, see FIGS. 1 and 2) can be configured to provide a working fluid (e.g., water, air, saline, any other fluid used during endoscopic procedures, or the like) to the endoscope 300. In examples, the working fluid can be provided to the handle 302 via the irrigation port 308. As discussed above, the handle 302 can include one or more working channels or lumens formed therein that can direct the working fluid through the handle 302 and into a working channel or lumen of the flexible member 340. In examples, the irrigation port 308 can also be used to provide suction to the endoscope 300, for example, the irrigation port 308 can provide suction at a distal end of the flexible member 340. ioSUBSTITUTE SHEET (RULE 26)
[0043] The suction port 310 (e.g., the port 138 or the port 140, see FIGS. 1 and 2) can be configured to provide suction or a vacuum to the endoscope 300 to remove tissue, liquid, or debris from the distal tip 301 of the endoscope 300.
[0044] The accessory port 312 can be configured to receive one or more ancillary devices (e.g., the ancillary device 318 such as a stone basket, an optical fiber, etc.) of the endoscope 300. As discussed herein, the handle 302 can include one or more working channels orworking lumens that can direct the ancillary device 318 introduced to the endoscope 300 via the accessory port 312 to and through one or more working lumens orworking channels of the flexible member 340. In some examples, the accessory port 312 can serve as an I / O connection port; the I / O connection port can be integrated in the accessory port 312 such that that the accessory port 312 can receive one or more ancillary device and provide I / O communication with such devices. The I / O connection port can be connected to an endoscope control unit that can receive the one or more signals from the components of the endoscope 300 and process the one or more signals. The signals and the processing of the signals will be discussed in more details herein. In other embodiments, an additional port (not shown) is served as the I / O connection port, while the accessory port 312 receives the desired ancillary device(s).
[0045] The steering mechanism 320 (e.g., the steering control 136, see FIG. 1 and 2) can be configured to be engaged by the endoscopist to steer the flexible member 340 and any component (e.g., one or more of the ancillary device 318 or any other device) within the flexible member 340 within the patient. In examples, such as the example shown in FIG. 3, the steering mechanism 320 can be an angulation lever operated with a thumb of the endoscopist. In examples, an actuation assembly or an engageable actuator mechanism (e.g., device 322) can be removably attached to the steering mechanism 320. In examples, the device 322 can be integrated with the steering mechanism 320 such that the device 322 is coupled to (or11SUBSTITUTE SHEET (RULE 26)formed on) the steering mechanism 320. The device 322 will be discussed in more detail herein with reference to FIGS. 4-13.
[0046] The flexible member 340 (e.g., the insertion section 126, see FIG. 1) can be an elongated member extending between a proximal portion 344 and a distal portion 346 that can be configured to be inserted into the patient. The flexible member 340 can define a working lumen 342 that can extend from the proximal portion 344 and the distal portion 346 of the flexible member 340. The distal portion 346 of the flexible member 340 can define a distal tip 301 of the endoscope 300.
[0047] The feeding machine 350 (e.g., the drive unit 206) can be configured to feed ancillary device 318 into and out of the accessory port 312. For example, the feeding machine 350 can extend the ancillary device 318 into the accessory port 312 such that the ancillary device 318 extends beyond the distal portion 346 of the flexible member 340. The feeding machine 350 can also retract the ancillary device 318 within the distal portion 346 of the flexible member 340 and out of the accessory port 312. In examples, the feeding machine 350 can be an external component that can be configured to feed the flexible member 340 into and out of the patient. For example, the feeding machine 350 can be used to navigate the flexible member 340 into the patient as the medical professional steers the flexible member 340 with the steering mechanism 320.
[0048] FIG. 4 is a front view of an example of an engageable actuator mechanism (e.g., the device 322). As discussed herein, the device 322 can be configured to be removably coupled to the steering mechanism 320 or can be integral to (e.g., fixed to) the steering mechanism 320. The device 322 can include a first side 360, a second side 362, and a central body 364. The central body 364 can be an elongated body that extends between the first side 360 and the second side 362. The first side 360 can include a first engageable assembly 366 and the second side 362 can include a second engageable assembly 368. The first side 360 can be opposite the central body 364 from the second side 362 such that the first engageable assembly 366 faces the second engageable assembly 368. As such, the thumb of an12SUBSTITUTE SHEET (RULE 26)endoscopist can be used to engage the first engageable assembly 366 and the second engageable assembly 368 by moving in a first direction A or a second direction B, respectively.
[0049] The first engageable assembly 366 can include a first engagement member 370 and one or more first switches (e.g., first switches 372). The first engagement member 370 can be elongated and can at least partially wrap around the central body 364. The partial wrap of the first engagement member 370 around the central body 364 permits the endoscopist to engage the first engagement member 370 as the steering mechanism 320 is operated toward the limits of the operable motion of the steering mechanism 320.
[0050] The first engagement member 370 can be connected to the first switches 372 such that the first switches 372 can detect when the endoscopist engages the first engagement member 370. The first switches 372 can be configured to generate a first signal 374 (shown in FIG. 7). The first signal 374 can be indicative of the endoscopist (or another medical professional) engaging the first engagement member 370. The first switches 372 can be attached to opposite ends of the first engagement member 370 to increase the likelihood that the first switches 372 will detect the endoscopist engagingthe first engagement member 370.
[0051] The second engageable assembly 368 can include a second engagement member 380 and one or more switches (e.g., second switches 382). The second engagement member 380 can be elongated and can at least partially wrap around the central body 364. The partial wrap of the second engagement member 380 around the central body 364 permits the endoscopist to engage the second engagement member 380 as the steering mechanism 320 is operated toward the limits of the operable motion of the steering mechanism 320.
[0052] The second engagement member 380 can be connected to the second switches 382 such that the second switches 382 can detect when the endoscopist engages the second engagement member 380. The second switches 382 can be configured to generate a second signal 38413SUBSTITUTE SHEET (RULE 26)(shown in FIG. 7). The second signal 384 can be indicative of the endoscopist (or another medical professional) engaging the second engagement member 380.
[0053] The central body 364 can include one or more wires 376. The one or more wires 376 can connect the first switches 372 to the second switches 382. The one or more wires 376 can also connect the first switches 372 and the second switches 382 to a control system (e.g., the control unit 114, see FIG. 2) that can control one or more parameters or components (e.g., the display unit 116, the input unit 118, the light source 120, the image processing unit 202, the treatment generator 204, the drive unit 206, orthe like) of the endoscope 300.
[0054] FIGS. 5 and 6 will be discussed together below. FIG. 5 is a perspective view of an example of the device 322 being attached to the endoscope 300. FIG. 6 is a perspective view of an example of the device 322 attached to the endoscope 300.
[0055] The device 322 can include an attachment interface 502. As shown in FIGS. 5 and 6, the attachment interface 502 can include support arms 504 and clips 506. The support arms 504 can extend from the first engagement member 370 and the second engagement member 380, respectively. In examples, the support arms 504 can engage with the steering mechanism 320 to provide support and help keep the device 322 attached to the steering mechanism 320. The clips 506 can extend from the central body 364 of the device 322 and can be configured to receive the steering mechanism 320 to couple the device 322 to the steering mechanism 320. As shown in FIGS. 5 and 6, the attachment interface 502 can include two of the clips 506. In examples, the attachment interface 502 can include a single clip 506, or three or more of the clips 506. The support arms 504 and the clips 506 of the attachment interface 502 can removably attach the device 322 to the steering mechanism 320.
[0056] FIG. 7 is a front view of an example of the device 322. As shown in FIGS. 5 and 7, the attachment interface 502 of the device 322 can include two of the support arms 504 to attach the device 322 to the steering14SUBSTITUTE SHEET (RULE 26)mechanism 320. For steering mechanisms 320 that only have one arm attached to the handle 302, the attachment interface 502 of the device 322 can include just one support arm 504 to provide lateral support to the device 322 when it is coupled to the steering mechanism 320. As such, the attachment interface 502 can include one or more of the clips 506 to help secure the device 322 to the steering mechanism 320. For example, in the example of the attachment interface 502 with one support arm 504, the attachment interface 502 may include one, two, three, or more of the clips 506 to help secure the device 322 to the steering mechanism 320.
[0057] As discussed in FIG. 2, the endoscope 104 or the medical device 108 (e.g., the endoscope 300, see FIG. 3) can include the control unit 114 and as discussed with reference to FIG. 4, the first switches 372 and the second switches 382 can generate the first signal 374 and the second signal 384, respectively. In response to receiving the first signal 374 or the second signal 384 from the first switches 372 and the second switches 382, respectively, the control unit 114 can adjust one or more parameters associated with the endoscope 300. For example, the control unit 114 can generate a control signal 702 in response to receiving the first signal 374 or the second signal 384. The control unit 114 can transmit the control signal 702 to any of the components of the endoscope 300 (e.g., the display unit 116, the input unit 118, the light source 120, the image processing unit 202, the treatment generator 204, the drive unit 206, orthe like).
[0058] In examples, the endoscope 300 and, more specifically, the control unit 114 can be programmed to run instructions stored on the memory based on receiving different variations of the first signal 374 or the second signal 384. For example, the control unit 114 can advance the ancillary device 318 to a specific point if the control unit 114 receives two of the first signals 374 or the second signals 384 in succession. In examples, the control unit 114 can be programmed to run one or more algorithms based on receiving any combination of the first signal 374 and the second signal 384, which can cause the control unit 114 to send the control signal15SUBSTITUTE SHEET (RULE 26)702 to one or more components of the endoscope 300 to change one or more parameters of the endoscope 300.
[0059] FIGS. 8-10 show examples of the endoscope 300, including the device 322, through a complete range of motion of the steering mechanism 320. More specifically, FIG. 8 is a side view of the endoscope 300 with the steering mechanism 320 in a first position 802. FIG. 9 is a side view of the endoscope 300 with the steering mechanism 320 in a second position 902. FIG. 10 is a side view of the endoscope 300 with the steering mechanism 320 in a third position 1002.
[0060] In examples, the first position 802 and the third position 1002 are the upper and lower limits of travel, respectively, of the steering mechanism 320. The second position 902 is the neutral or central position of the steering mechanism 320. As discussed herein, the first engagement member 370 (FIG. 4) and the second engagement member 380 are designed such that the endoscopist, doctor, nurse, or other medical professionals can engage with the first engagement member 370 and the second engagement member 380 (FIG. 4) through the entire range of motion of the steering mechanism 320 (i.e., between the first position 802 and the third position 1002).
[0061] FIGS. 11 and 12 will be discussed together. FIGS. 11 and 12 show an example of an actuation device 1122 that can be installed on an example of an endoscope 1100 (FIG. 12). FIG. 11 is a schematic diagram of an example of the actuation device 1122. FIG. 12 is a perspective view of an example of the actuation device 1122 installed on the endoscope 1100. The endoscope 1100 can include a steering mechanism 1120 (FIG. 12). The steering mechanism 1120 can include a knob 1121 (FIG. 12) that can be actuated to steer the elongated member of the endoscope 1100. As such, actuation device 1122 needs to be adjusted to work with the steering mechanism 1120 with the knob 1121.
[0062] In examples, the actuation device 1122 can be configured to attach to the endoscope 1100 in a spacing or gap between the knob 1121 and a handle 1102 of the endoscope 1100. The actuation device 1122 can16SUBSTITUTE SHEET (RULE 26)include an aperture 1124, a cutout portion 1126, an engagement member1128, a first switch 1130, and a second switch 1132.
[0063] The aperture 1124 can be configured to fit onto the endoscope 1100. Specifically, the aperture 1124 can fit around a shaft that connects the knob 1121 to the handle 1102 of the endoscope 1100. The aperture 1124 can include an opening 1125 that permits the actuation device 1122 to slide onto the shaft of the knob 1121 . A diameter D of the aperture 1124 can be adjusted to accommodate shafts of the knob 1121 of various sizes. The aperture 1124 can include notches 11 T1 adjacent the opening 1125, which can help secure and locate the actuation device 1122 on the endoscope 1100.
[0064] The cutout portion 1126 can allow the actuation device 1122 to flex as the actuation device 1122 is being installed on the endoscope 1100. The length and width of the cutout portion 1126 can be adjusted based on the amount of flex required to install the actuation device 1122 thereon the endoscope 1100.
[0065] The engagement member 1128 can be configured to translate between a first direction A and a second direction B. The engagement member 1128 can be engaged by the endoscopist, operator of the endoscope, other medical professional, orthe like. The engagement member 1128 can engage with the first switch 1130 when the engagement member 1128 translates in the first direction A and the second switch 1132 when the engagement member 1128 translates in the second direction B. In examples, the engagement member 1128 can be another button, or engagement memberthat can be engaged by an operator of the endoscope 1100. For example, the engagement member 1128 can be compressed, twisted, rotated, or the like, to engage with the first switch 1130, the second switch 1132, or any other switch that can detect an operator engaging the engagement member 1128.
[0066] The first switch 1130 can be configured to generate the first signal 374 (first shown in FIG. 4) upon engagement of the engagement member 1128 in the first direction A. The second switch 1132 can be17SUBSTITUTE SHEET (RULE 26)configured to generate the second signal 384 (first shown in FIG. 4) upon engagement of the engagement member 1128 in the second direction B. Thus, the first switch 1130 and the second switch 1132 can be in communication with the control unit 114 to control one or more systems, components, or parameters of the endoscope 1100 upon the translation of the engagement member 1128 in the first direction A or the second direction B, respectively.
[0067] FIG. 13 is a schematic diagram of an example of an endoscopic system 1300 includingtwo feed machines. For example, the endoscopic system 1300 can include a first feed machine 1302 and a second feed machine 1304. The first feed machine 1302 and the second feed machine 1304 (e.g., the feeding machine 350, see FIG. 3) can be configured to feed an elongated member 1306 and an ancillary device 1308, respectively.
[0068] In examples, the endoscopic system 1300 can include any number of feed machines to feed any components, devices, or systems of the endoscopic system 1300 upon direction by the endoscopist, medical professional, or the like. As discussed herein, the control system (e.g., the control unit 114, see FIG. 2) can be programmed to control any components, devices, or systems of the endoscopic system 1300 in response to receiving any combination of the first signal 374 (FIG. 7) or the second signal 384 (FIG. 7). For example, if the control unit 114 receives one instance of the first signal 374, the control unit 114 can send a controlling signal to the first feed machine 1302 to advance the elongated member 1306 and the control unit 114 can send a controlling signal to the second feed machine 1304 to advance the ancillary device 1308 upon receiving multiple instances of the first signal 374. This is just an exemplary case, and as discussed herein, the control unit 114 can use any combination of the first signal 374 and the second signal 384 to control any systems, components, or parameters of the endoscopic system 1300.
[0069] FIG. 14 illustrates a schematic view of an example method 1400. The method 1400 can be a method of reprocessing a bronchoscope18SUBSTITUTE SHEET (RULE 26)(e.g., the endoscope 104, the endoscope 300, or the like). More specific examples of the method 1400 are discussed below. The steps or operations of the method 1400 are illustrated in a particular orderfor convenience and clarity; many of the discussed operations can be performed in a different sequence or in parallel without materially impacting other operations. The method 1400 as discussed includes operations performed by multiple different actors, devices, or systems. It is understood that subsets of the operations discussed in the method 1400 can be attributable to a single actor, device, or system could be considered a separate standalone process or method.
[0070] The reprocessing method 1400 for the above-described treatment instrument (e.g., the endoscope 104 or the endoscope 300) will be described with reference to FIG. 14. The treatment instrument (e.g., the endoscope 104 orthe endoscope 300) described above can be disposed of after one use, or can be repeatedly used, for example, a plurality of times. In the case of a configuration that is repeatedly used a plurality of times, for example, the reprocessing method 1400 shown in FIG. 14 can be relevant.
[0071] An operator can collect the used treatment instrument (e.g., the endoscope 104 or the endoscope 300) after it has been used for treatment and transport it to a factory or the like (Step S1 ). At this time, the used treatment instrument (e.g., the endoscope 104 orthe endoscope 300) can be transported in a dedicated containerto prevent contamination from the treatment instrument (e.g., the endoscope 104 orthe endoscope 300).
[0072] Then, the operator can clean and sterilize the collected and transported used treatment instrument (e.g., the endoscope 104 orthe endoscope 300) (Step S2). Specifically, in cleaning the treatment instrument (e.g., the endoscope 104 orthe endoscope 300), deposits adhering to the distal tip 301 , the handle 302, the steering mechanism 320, the device 322, flexible member 340, or the like, can be removed by using a brush or the like. After that, to remove pathogenic microorganisms and the like derived from blood, body fluid, etc., the distal19SUBSTITUTE SHEET (RULE 26)tip 301 , the handle 302, the steering mechanism 320, the device 322, flexible member 340, or the like, can be cleaned using a cleaning solution of isopropanol-containing cleaning agent, proteolytic enzyme detergent, and alcohol. The cleaning liquid is not limited to the cleaning liquid described above, and other cleaning liquids may be used. Further, in the sterilization of the treatment instrument (e.g., the endoscope 104 or the endoscope 300), to sterilize the pathogenic microorganisms and the like adheringto the distal tip 301 , the handle 302, the steering mechanism 320, the device 322, flexible member 340, or the like, any of high-pressure steam sterilization, ethylene oxide gas sterilization, gamma ray sterilization, hydrogen peroxide and hydrogen peroxide low-temperature sterilization can be used. The distal tip 301 , the handle 302, the steering mechanism 320, the device 322, flexible member 340, or the like can be disassembled by actuatingthe clips or securingfeatures to decouple the components of the endoscope 300.
[0073] The operator can perform an acceptance check of the used treatment instrument (e.g., the endoscope 104 orthe endoscope 300) (Step S3). In detail, the operator can check whetherthe used treatment instrument (e.g., the endoscope 104 orthe endoscope 300) has significant defects or whether the used treatment instrument (e.g., the endoscope 104 orthe endoscope 300) exceeds a maximum number of reprocessing.
[0074] Next, the operator can disassemble the used treatment instrument (e.g., the endoscope 104 orthe endoscope 300) (Step S4). Can disassemble the endoscope 300 by removing any of the handle 302, the steering mechanism 320, the device 322, flexible member 340, or the like.
[0075] After the step S4, some parts are replaced (Step S5). For example, any of the distal tip 301 , the handle 302, the steering mechanism 320, the device 322, flexible member 340, or the like can be replaced during step S4.
[0076] After step S5, the operator can assemble a new treatment instrument (e.g., the endoscope 104 orthe endoscope 300) (Step S6). In some examples, Step S6 can include adding an identifierto indicate the20SUBSTITUTE SHEET (RULE 26)device has been modified from its original condition, such as a adding a label or other marking to designate the device as reprocessed, refurbished or remanufactured.
[0077] After step S6, the operator can inspect and test the newly formed treatment instrument (e.g., the endoscope 104 or the endoscope 300) (step S7). Specifically, the operator who remanufactures verifies that the newly formed treatment instrument (e.g., the endoscope 104 or the endoscope 300) has the same effectiveness and safety as the original product by various functional tests.
[0078] After Step S7, the operator sequentially performs a sterilization and storage (Step S8), and shipping (Step S9) of the new treatment instrument (e.g., the endoscope 104 orthe endoscope 300). In the Step S8, a sterilization treatment can use a sterilizing gas such as ethylene oxide gas or propylene oxide gas is applied to the new treatment instrument (e.g., the endoscope 104 or the endoscope 300), and the device is stored in a storage container until use.
[0079] Steps S1 to S9 described above are executed to achieve reprocessing of the treatment instrument (e.g., the endoscope 104 orthe endoscope 300). Any of steps S1-S9 can be completed by one or more parties in any order of the steps. Moreover, steps S1-S9 are exemplary steps, which are not an all-inclusive list of steps that can be performed by an operator to refurbish, remanufacture, or replenish the medical instrument (e.g., the endoscope 104 orthe endoscope 300).
[0080] FIG. 15 illustrates a block diagram of an example machine 1500 upon which any one or more of the techniques (e.g., methodologies) discussed herein may perform. Examples, as described herein, may include, or may operate by, logic or a number of components, or mechanisms in the machine 1500. Circuitry (e.g., processing circuitry) is a collection of circuits implemented in tangible entities of the machine 1500 that include hardware (e.g., simple circuits, gates, logic, etc.). Circuitry membership may be flexible overtime. Circuitries include members that may, alone or in combination, perform specified operations when21SUBSTITUTE SHEET (RULE 26)operating. In examples, hardware of the circuitry may be immutably designed to carry out a specific operation (e.g., hardwired). In examples, the hardware of the circuitry may 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 examples, 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 may be used in more than one member of more than one circuitry. For example, under operation, execution units may 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 1500 follow.
[0081] In alternative examples, the machine 1500 may operate as a standalone device or may be connected (e.g., networked) to other machines. In a networked deployment, the machine 1500 may operate in the capacity of a server machine, a client machine, or both in server-client network environments. In examples, the machine 1500 may act as a peer machine in peer-to-peer (P2P) (or other distributed) network environment. The machine 1500 may 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 be22SUBSTITUTE SHEET (RULE 26)taken by that machine. Further, while only 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.
[0082] The machine (e.g., computer system) 1500 may include a hardware processor 1502 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof), a main memory 1504, a static memory (e.g., memory or storage for firmware, microcode, a basic-input-output (BIOS), unified extensible firmware interface (UEFI), etc.) 1506, and mass storage 1508 (e.g., hard drives, tape drives, flash storage, or other block devices) some or all of which may communicate with each other via an interlink (e.g., bus) 1530. The machine 1500 may further include a display unit 1510, an alphanumeric input device 1512 (e.g., a keyboard), and a user interface (Ul) navigation device 1514 (e.g., a mouse). In examples, the display unit 1510, input device 1512 and Ul navigation device 1514 may be a touch screen display. The machine 1500 may additionally include a storage device (e.g., drive unit) 1508, a signal generation device 1518 (e.g., a speaker), a network interface device 1520, and one or more sensors 1516, such as a global positioning system (GPS) sensor, compass, accelerometer, or other sensor. The machine 1500 may include an output controller 1528, 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.).
[0083] Registers of the processor 1502, the main memory 1504, the static memory 1506, or the mass storage 1508 may be, or include, a machine readable medium 1522 on which is stored one or more sets of data structures or instructions 1524 (e.g., software) embodying or utilized by any one or more of the techniques orfunctions described herein. The23SUBSTITUTE SHEET (RULE 26)instructions 1524 may also reside, completely or at least partially, within any of registers of the processor 1502, the main memory 1504, the static memory 1506, or the mass storage 1508 during execution thereof by the machine 1500. In examples, one or any combination of the hardware processor 1502, the main memory 1504, the static memory 1506, or the mass storage 1508 may constitute the machine-readable media 1522. While the machine-readable medium 1522 is illustrated as a single medium, the term “machine-readable medium” may include a single medium or multiple media (e.g., a centralized or distributed database and / or associated caches and servers) configured to store the one or more instructions 1524.
[0084] The term “machine-readable medium” may include any medium that is capable of storing, encoding, or carrying instructions for execution by the machine 1500 and that causes the machine 1500 to perform any one or more of the techniques of 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 may include solid-state memories, optical media, magnetic media, and signals (e.g., radio frequency signals, other photon-based signals, sound signals, etc.). In examples, 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 may include: nonvolatile 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; magnetooptical disks; and CD-ROM and DVD-ROM disks.
[0085] In examples, information stored or otherwise provided on the machine readable medium 1522 may be representative of the instructions24SUBSTITUTE SHEET (RULE 26)1524, such as instructions 1524 themselves or a format from which the instructions 1524 may be derived. This format from which the instructions 1524 may be derived may 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 1524 in the machine-readable medium 1522 may be processed by processing circuitry into the instructions to implement any of the operations discussed herein. For example, deriving the instructions 1524 from the information (e.g., processing by the processing circuitry) may 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 1524.
[0086] In examples, the derivation of the instructions 1524 may include assembly, compilation, or interpretation of the information (e.g., by the processing circuitry) to create the instructions 1524 from some intermediate or preprocessed format provided by the machine readable medium 1522. The information, when provided in multiple parts, may be combined, unpacked, and modified to create the instructions 1524. For example, the information may be in multiple compressed source code packages (or object code, or binary executable code, etc.) on one or several remote servers. The source code packages may 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, standalone executable etc.) at a local machine, and executed by the local machine.
[0087] The instructions 1524 may be further transmitted or received over a communications network 1526 using a transmission medium via the network interface device 1520 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 may include a local area25SUBSTITUTE SHEET (RULE 26)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) 602.11 family of standards known as Wi-Fi®, IEEE 602.15.4 family of standards, peer-to-peer (P2P) networks, among others. In examples, the network interface device 1520 may include one or more physical jacks (e.g., Ethernet, coaxial, or phonejacks) or one or more antennas to connect to the communications network 1526. In examples, the network interface device 1520 may include a plurality of antennas to wirelessly communicate using at least one of single-input multiple-output (SIMO), multiple-input multiple-output (MIMO), or multiple-input singleoutput (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 1500, 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.
[0088] FIG. 16 shows a schematic diagram of an exemplary computer-based clinical decision support system (CDSS) 1600 that is configured to control one or more aspects of the endoscopic system (e.g., the endoscopy system 100, the endoscope 104, the medical device 108, see FIG. 1 , the endoscope 300, see FIG. 3, or the like, based on input from any one of the components of the endoscopic system (e.g., the control unit 114, the display unit 116, the input unit 118, the light source 120, the fluid source 122, the suction pump 124, the steering control 136 (all in FIG. 1), or the like), signals transmitted based on engagement with either of the first engagement member or the second engagement member (e.g., first signal 374 (FIG. 7) from the first engagement member 370 (FIG. 3) or the second signal 384 (FIG. 7) from the second engagement member 380, see FIG. 3). In examples, the CDSS 1600 can include an input interface 1602 through26SUBSTITUTE SHEET (RULE 26)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) model 1604. A processor 1606 (e.g., the control unit 114 (FIG. 1) or the hardware processor 1502, see FIG. 15) 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 (Ul) through which suggested medical procedure is communicated to a user, e.g., a clinician.
[0089] In some embodiments, the input interface 1602 may be a direct data link between the CDSS 1600 and one or more medical devices (e.g., the endoscopy system 100, see FIG. 1 , the endoscope 104, see FIG. 1 , the medical device 108, see FIG. 1 the endoscope 300, see FIG. 3, or the like, that can generate at least some of the input features. For example, the input interface 1602 may 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 1602 may be a classical user interface that facilitates interaction between a user and the CDSS 1600. For example, the input interface 1602 may facilitate a user interface through which the user may manually enter medical information, procedure-specific information, or the like. Additionally, or alternatively, the input interface 1602 may provide the CDSS 1600 with access to an electronic patient record from which one or more input features may be extracted. Such electronic patient records can be stored on a database 1601 . In any of these cases, the input interface 1602 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 which27SUBSTITUTE SHEET (RULE 26)the CDSS 1600 is used to assess the safest and most efficient procedure to complete a planned medical procedure.
[0090] In examples, medical information, such as, age, weight, sex, which are specific to a patient, or procedure specific information, such as, location of anomaly can be provided to the CDSS 1600 via the input interface 1602.
[0091] In examples, medical procedure information, such as, the planned path for the procedure, planned steps of the procedure can also be provided to the CDSS 1600 via the input interface 1602.
[0092] In examples, any one of the components of the endoscopic system (e.g., the control unit 114, the display unit 116, the input unit 118, the light source 120, the fluid source 122, the suction pump 124, the steering control 136 (all in FIG. 1 ), or the like), can provide input to the CDSS 1600 via the input interface 1602.
[0093] In examples, signals transmitted based on engagement with either of the first engagement member or the second engagement member (e.g., first signal 374 (FIG. 7) from the first engagement member 370 (FIG. 3) or the second signal 384 (FIG. 7) from the second engagement member 380, see FIG. 3) can provide input to the CDSS 1600 via the input interface 1602.
[0094] Based on one or more of the above input features, the processor 1606 performs an inference operation using the Al model 1604 to generate the safest and most efficient medical procedure to perform the medical task. For example, input interface 1602 may 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 1604which propagates these input features through the Al model 1604 to an output layer. The Al model 1604 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 1604 explores28SUBSTITUTE SHEET (RULE 26)the study and construction of algorithms (e.g., machine-learning algorithms) that may 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.
[0095] 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, best approximates 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 allowingthe algorithm to act on that information without guidance. Unsupervised ML is useful in exploratory analysis because it can automatically identify structure in data.
[0096] 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).
[0097] 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 autoencoders.
[0098] Another type of ML is federated learning (also known as collaborative learning) that trains an algorithm across multiple29SUBSTITUTE SHEET (RULE 26)decentralized devices holding local data, without exchangin the data. This approach stands in contrast to traditional centralized machine-learning techniques where all 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, thus allowing to address critical issues such as data privacy, data security, data access rights and access to heterogeneous data.
[0099] In some examples, the Al model may be trained continuously or periodically prior to performance of the inference operation by the processor 1606. Then, duringthe inference operation, the patient specific input features provided to the Al model may 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, size of the patient, or any other medical information of the patient, and the medical information, such as, the location of the patient indicate the sample may be difficult to obtain, the processor 1606 can suggest a smaller version of the endoscope, suggest a different path that can maximize imaging and sampling efforts, or suggest a maximum energy used for any cutting, ablation, or removal procedures.
[0100] During and / or subsequent to the inference operation, the output interface 1608 can transmit any of the safest and most efficient medical procedure may be communicated to the user via the user interface (Ul) 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 1606 can transmit a signal to the light source 120 to alter the brightness, color, saturation, or any other light parameter, of the light transmitted, send a controlling signal to the fluid source 122 (FIG. 1 ) to change a fluid supplied to the suction pump 124 (FIG. 1 ), send a signal to the suction pump 124 to alter a velocity or volume of fluid supplied to the imaging site, send a signal to the suction pump 124 to increase or decrease an amount of suction provided to the imaging site. These are exemplary30SUBSTITUTE SHEET (RULE 26)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 application have 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.
[0101] The following, non-limiting examples, detail certain aspects of the present subject matter to solve the challenges and provide the benefits discussed herein, among others.
[0102] Example 1 is a medical instrument for insertion into a patient, the medical instrument comprising: an elongated member insertable into the patient, the elongated member extending between a proximal portion and a distal portion, the elongated member defining a lumen extending from the proximal portion to the distal portion; a handle section extending between a proximal end and a distal end, the distal end connected to the proximal portion of the elongated member, the handle section including: an accessory port to receive an ancillary device, the accessory port connected to the lumen; a feeding machine operable to control the insertion and retraction of the ancillary device within the lumen; and an actuation assembly operable to send a first signal and a second signal to the feeding machine, the first signal advances the ancillary device into the accessory port, and the second signal retracts the ancillary device from the accessory port.
[0103] In Example 2, the subject matter of Example 1 includes, wherein the handle section comprises: a steering mechanism operable to steer the elongated member within the patient.
[0104] In Example 3, the subject matter of Example 2 includes, wherein the actuation assembly is removably coupled to the steering mechanism.
[0105] In Example 4, the subject matter of Example 3 includes, wherein the actuation assembly comprises: an elongated body comprising: a first end portion; and a second end portion, the second end portion31SUBSTITUTE SHEET (RULE 26)opposite the first end portion; a first engageable assembly disposed adjacent to the first end portion, the first engageable assembly operable to generate the first signal; and a second engageable assembly disposed adjacent to the second end portion, the second engageable assembly operable to generate the second signal.
[0106] In Example 5, the subject matter of Example 4 includes, wherein the first engageable assembly comprises: a first engagement member; and one or more switches, the one or more switches operable to detect when the first engagement member is engaged by a user of the medical instrument and generate the first signal.
[0107] In Example 6, the subject matter of Example 5 includes, wherein the second engageable assembly comprises: a second engagement member, the second engagement member positioned to face the first engagement member; and one or more switches, the one or more switches operable to detect when the second engagement member is engaged by a user of the medical instrument and generate the second signal.
[0108] In Example 7, the subject matter of Examples 4-6 includes, wherein the actuation assembly comprises: an attachment interface to removably attach the actuation assembly to the steering mechanism.
[0109] In Example 8, the subject matter of Examples 1 -7 includes, controller circuitry for adjusting a parameter associated with the medical instrument based at least in part on the first signal and the second signal.
[0110] In Example 9, the subject matter of Example 8 includes, wherein the controller circuitry is coupled to memory circuitry including stored instructions that, when performed by the controller circuitry, cause the controller circuitry to: receive the first signal from the actuation assembly; update one or more parameters of the medical instrument based at least in part by the first signal; generate a first control signal indicative of the update to the one or more parameters of the medical instrument; and transmit the first control signal to one or more components of the medical instrument.32SUBSTITUTE SHEET (RULE 26)
[0111] In Example 10, the subject matter of Example 9 includes, wherein the first control signal directs the feeding machine to advance the ancillary device to a set position.
[0112] In Example 11 , the subject matter of Examples 8-10 includes, wherein the controller circuitry is coupled to memory circuitry, including stored instructions that, when performed by the controller circuitry, cause the controller circuitry to: receive the second signal from the actuation assembly; update one or more parameters of the medical instrument based at least in part by the second signal; generate a second control signal indicative of the update to the one or more parameters of the medical instrument; and transmit the second control signal to one or more components of the medical instrument.
[0113] In Example 12, the subject matter of Example 11 includes, wherein the second control signal directs the feeding machine to retract the ancillary device the accessory port.
[0114] Example 13 is an actuation assembly configured to be attached to a medical instrument, the actuation assembly comprising: an elongated body comprising: a first end portion; and a second end portion, the second end portion opposite the first end portion; a first engageable assembly disposed adjacent to the first end portion, the first engageable assembly operable to generate a first signal; and a second engageable assembly disposed adjacent to the second end portion, the second engageable assembly operable to generate a second signal, the first signal and the second signal transmitted to the medical instrument to control one or more parameters of the medical instrument.
[0115] In Example 14, the subject matter of Example 13 includes, an attachment interface to removably couple the actuation assembly to a steering mechanism of the medical instrument.
[0116] In Example 15, the subject matter of Example 14 includes, wherein the first engageable assembly comprises: a first engagement member; and one or more switches, the one or more switches operable to33SUBSTITUTE SHEET (RULE 26)detect when the first engagement member is engaged by a user of the medical instrument and generate the first signal.
[0117] In Example 16, the subject matter of Example 15 includes, wherein the second engageable assembly comprises: a second engagement member, the second engagement member positioned to face the first engagement member; and one or more switches, the one or more switches operable to detect when the first engagement member is engaged by a user of the medical instrument and generate the second signal.
[0118] Example 17 is a method for reprocessing an endoscope, the method comprising: obtaining an endoscope; sterilizing the endoscope; and storingthe endoscope.
[0119] In Example 18, the subject matter of Example 17 includes, wherein the endoscope includes a handle including a steering mechanism, and wherein an actuation devices is attached to the steering mechanism.
[0120] In Example 19, the subject matter of Example 18 includes, removingthe actuation device from the steering mechanism; sanitizingthe handle, the steering mechanism, and the actuation device; and packaging the handle, the steering mechanism, and the actuation device.
[0121] In Example 20, the subject matter of Examples 18-19 includes, wherein the actuation device includes one or more engagement members connected to one or more switches, and wherein the method comprises: testing the one or more engagement members and one or more switches; replacing any of the one or more engagement members or the one or more switches; and reinstalling the actuation device onto the steering mechanism.
[0122] Example 21 is an apparatus comprising means to implement of any of Examples 1-20.
[0123] Example 22 is a system to implement of any of Examples 1- 20.
[0124] Example 23 is a method to implement of any of Examples 1- 20.34SUBSTITUTE SHEET (RULE 26)
[0125] Example 24 is an apparatus, system, or a method including any element of any of Examples 1-20.
[0126] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, byway of illustration, specific examples that may be practiced. These embodiments are also referred to herein as “examples.” Such examples may 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.
[0127] 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.
[0128] 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.35SUBSTITUTE SHEET (RULE 26)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.
[0129] The term “about,” as used herein, means approximately, in the region of, roughly, or around. When the term “about” is used in conjunction with a numerical range, it modifies that range by extending the boundaries above and belowthe 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%. Numerical 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.”
[0130] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other examples may 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 may 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 may lie in less than all features of a particular disclosed example. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate example. The scope of the examples36SUBSTITUTE SHEET (RULE 26)should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.
[0131] 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 at least one use. 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.
[0132] 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 orTYVEK® 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 may also be sterilized using any other technique known in the art, including but limited to beta or gamma radiation, ethylene oxide, or steam.37SUBSTITUTE SHEET (RULE 26)
Claims
CLAIMS1 . A medical instrument for insertion into a patient, the medical instrument comprising: an elongated member insertable into the patient, the elongated member extending between a proximal portion and a distal portion, the elongated member defining a lumen extending from the proximal portion to the distal portion; a handle section extending between a proximal end and a distal end, the distal end connected to the proximal portion of the elongated member, the handle section including: an accessory port to receive an ancillary device, the accessory port connected to the lumen; a feeding machine operable to control the insertion and retraction of the ancillary device within the lumen; and an actuation assembly operable to send a first signal and a second signal to the feeding machine, the first signal advances the ancillary device into the accessory port, and the second signal retracts the ancillary device from the accessory port.
2. The medical instrument of claim 1 , wherein the handle section comprises: a steering mechanism operable to steer the elongated member within the patient.
3. The medical instrument of claim 2, wherein the actuation assembly is removably coupled to the steering mechanism.
4. The medical instrument of claim 3, wherein the actuation assembly comprises: an elongated body comprising:38SUBSTITUTE SHEET (RULE 26)a first end portion; and a second end portion, the second end portion opposite the first end portion; a first engageable assembly disposed adjacent to the first end portion, the first engageable assembly operable to generate the first signal; and a second engageable assembly disposed adjacent to the second end portion, the second engageable assembly operable to generate the second signal.
5. The medical instrument of claim 4, wherein the first engageable assembly comprises: a first engagement member; and one or more switches, the one or more switches operable to detect when the first engagement member is engaged by a user of the medical instrument and generate the first signal.
6. The medical instrument of claim 5, wherein the second engageable assembly comprises: a second engagement member, the second engagement member positioned to face the first engagement member; and one or more switches, the one or more switches operable to detect when the second engagement member is engaged by a user of the medical instrument and generate the second signal.
7. The medical instrument of claim 4, wherein the actuation assembly comprises: an attachment interface to removably attach the actuation assembly to the steering mechanism.
8. The medical instrument of claim 1 , comprising:39SUBSTITUTE SHEET (RULE 26)controller circuitry for adjusting a parameter associated with the medical instrument based at least in part on the first signal and the second signal.
9. The medical instrument of claim 8, wherein the controller circuitry is coupled to memory circuitry including stored instructions that, when performed by the controller circuitry, cause the controller circuitry to: receive the first signal from the actuation assembly; update one or more parameters of the medical instrument based at least in part by the first signal; generate a first control signal indicative of the update to the one or more parameters of the medical instrument; and transmit the first control signal to one or more components of the medical instrument.
10. The medical instrument of claim 9, wherein the first control signal directs the feeding machine to advance the ancillary device to a set position.11 . The medical instrument of claim 8, wherein the controller circuitry is coupled to memory circuitry, including stored instructions that, when performed by the controller circuitry, cause the controller circuitry to: receive the second signal from the actuation assembly; update one or more parameters of the medical instrument based at least in part by the second signal; generate a second control signal indicative of the update to the one or more parameters of the medical instrument; and transmit the second control signal to one or more components of the medical instrument.40SUBSTITUTE SHEET (RULE 26)12. The medical instrument of claim 11 , wherein the second control signal directs the feeding machine to retract the ancillary device the accessory port.
13. An actuation assembly configured to be attached to a medical instrument, the actuation assembly comprising: an elongated body comprising: a first end portion; and a second end portion, the second end portion opposite the first end portion; a first engageable assembly disposed adjacent to the first end portion, the first engageable assembly operable to generate a first signal; and a second engageable assembly disposed adjacent to the second end portion, the second engageable assembly operable to generate a second signal, the first signal and the second signal transmitted to the medical instrument to control one or more parameters of the medical instrument.
14. The actuation assembly of claim 13, comprising: an attachment interface to removably couple the actuation assembly to a steering mechanism of the medical instrument.
15. The actuation assembly of claim 14, wherein the first engageable assembly comprises: a first engagement member; and one or more switches, the one or more switches operable to detect when the first engagement member is engaged by a user of the medical instrument and generate the first signal.41SUBSTITUTE SHEET (RULE 26)16. The actuation assembly of claim 15, wherein the second engageable assembly comprises: a second engagement member, the second engagement member positioned to face the first engagement member; and one or more switches, the one or more switches operable to detect when the first engagement member is engaged by a user of the medical instrument and generate the second signal.
17. A method for reprocessing an endoscope, the method comprising: obtaining the endoscope; sterilizing the endoscope; and storingthe endoscope.
18. The method of claim 17, wherein the endoscope includes a handle including a steering mechanism, and wherein an actuation device is attached to the steering mechanism.
19. The method of claim 18, comprising: removingthe actuation device from the steering mechanism; sanitizingthe handle, the steering mechanism, and the actuation device; and packaging the handle, the steering mechanism, and the actuation device.
20. The method of claim 18, wherein the actuation device includes one or more engagement members connected to one or more switches, and wherein the method comprises: testing the one or more engagement members and one or more switches;42SUBSTITUTE SHEET (RULE 26)replacing any of the one or more engagement members or the one or more switches; and reinstalling the actuation device onto the steering mechanism.43SUBSTITUTE SHEET (RULE 26)
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