The present disclosure relates generally to medical devices comprising elongate bodies configured to be inserted into incisions or openings in anatomy of a patient to provide diagnostic or treatment operations.
More specifically, the present disclosure relates to endoscopes for imaging and/or providing passage of therapeutic devices toward various anatomical portions, including gastrointestinal tract (e.g., esophagus, stomach, duodenum, pancreaticobiliary duct, intestines, colon, and the like), renal area (e.g., kidney(s), ureter, bladder, urethra) and other internal organs (e.g., reproductive systems, sinus cavities, submucosal regions, respiratory tract), and the like.
Conventional endoscopes can be involved 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, and providing suction passageways for collecting fluids (e.g., saline or other preparations) and the like.
In conventional endoscopy, the distal portion of the endoscope can be configured for supporting and orienting a therapeutic device, such as with the use of an elevator. However, such distal portions can, in a few instances, lead to difficulty in sterilizing or reprocessing the distal portion after use. For example, conventional endoscopy devices can be completely reusable such that crevices between components or spaces within functional components of the distal portion can be difficult to access and clean.
The present inventors have recognized that problems to be solved with conventional medical devices, and in particular endoscopes and duodenoscopes, include, among other things, particularly those that are difficult or not configured to be easily disassembled, 1) the need and difficulty of cleaning and sterilizing endoscopes after usage, 2) the cost of maintaining multiple endoscopes in inventory to perform different surgical techniques or therapeutic methods on different patients, and 3) the cost of purchasing medical devices having excess capacity or unwanted capabilities for a particular patient. The present disclosure can help provide solutions to these and other problems by providing systems, devices and methods for designing, building, using and deconstructing modular endoscopes. In particular, the present application is directed to attachment systems for detachable camera modules and detachable control modules for medical devices such as endoscopes and duodenoscopes. The camera modules and control modules can be configured for reuse after appropriate cleaning and sterilization, while the insertion sheaths and shafts to which they can be configured to connect can be configured for one-time use. As such, more expensive camera and control components can be modularly attached to inexpensive, disposable insertion sheaths and shafts. Said modular camera and control components can be configured for cleaning, e.g., by being encapsulated, while the insertion sheath and shafts can be inexpensively made to perform only the desired procedure and then disposed of after use. Such configurations can eliminate the need to clean in difficult to reach places in fully assembled devices and the need to maintain a large inventory of devices with different or excess capabilities.
The present inventors have also recognized that problems to be solved with conventional medical devices, and in particular endoscopes and duodenoscopes, include, among other things, the potential difficulty presented by having to attach modular components and the associated need to have attached modular components remain attached during a procedure. The present disclosure can help provide solutions to these and other problems by providing systems, devices and methods comprising attachment mechanisms for modular components, particularly modular imaging and illuminating units. The attachment systems described herein can facilitate simple and easy assembly such that, if needed, surgeons and other personnel can assemble the camera module to an insertion module in an operating room environment, yet can still provide adequate coupling to prevent unintended or accidental dislodgement of the camera module from the insertion module, such as when the insertion module is being used to insert the camera module into a patient.
The present inventors have additionally recognized that problems to be solved with conventional medical devices, and in particular endoscopes and duodenoscopes, include, among other things, the need for controlling endoscopes having different capabilities. In particular, modular endoscopes can be built with modular functional components that perform a wide variety of tasks, including different treatment options such as cutting, cauterizing, ablating and the like. As such, conventional endoscope control devices can be limited in accommodating additional functionality or adapting to modular accessories. The present disclosure can help provide solutions to these and other problems by providing systems, devices and methods comprising module control modules that can be coupled to proximal ends of insertion modules to control different functional modules attached to distal ends of the insertion modules. The control modules of the present disclosure can be provided with a wide variety of inputs, e.g., buttons, joysticks and touchscreens, that can be configured to control a variety of outputs.
In an example, modular endoscopy system can comprise a first modular section comprising control and navigation functionality, and a second modular section user-detachably connectable to the first modular section via an attachment mechanism, the second modular section being patient insertable, wherein the first modular section is positionable at a proximal end section of the second modular section and is configured to steer and bend a portion of the second modular section.
In another example, a method of using a modular endoscopy system can comprise attaching a first modular section of the modular endoscopy system to a second modular section of the modular endoscopy system, positioning at least a portion of the modular endoscopy system within a patient, steering a portion of the second modular section to an anatomy location of the patient via the first modular section, removing the modular endoscopy system from the patient, and detaching the second modular section from the first modular section after removal of the modular endoscopy system from the patient.
In an additional example, a navigation and control module for an endoscope can comprise an ergonomically shaped housing, a joystick mounted to the housing in an articulable manner, and an angulation wire connected to the joystick.
In another example, a method of controlling an endoscope comprises coupling an insertion section module of the endoscope to a motorized drive device, establishing a wireless communication connection between the motorized drive device and a navigation and control module, executing gestures on a touchscreen of the navigation and control module to control axial movement of the insertions section module with the motorized drive device.
Imaging and control system 12 can comprise controller 16, output unit 18, input unit 20, light source 22, fluid source 24 and suction pump 26.
Imaging and control system 12 can include various ports for coupling with endoscopy system 10. For example, controller 16 can include a data input/output port for receiving data from and communicating data to endoscope 14. Light source 22 can include an output port for transmitting light to endoscope 14, such as via a fiber optic link. Fluid source 24 can include a port for transmitting fluid to endoscope 14. Fluid source 24 can comprise a pump and a tank of fluid or can be connected to an external tank, vessel or storage unit. Suction pump 26 can comprise a port used to draw a vacuum from endoscope 14 to generate suction, such as for withdrawing fluid from the anatomical region into which endoscope 14 is inserted. Output unit 18 and input unit 20 can be used by an operator of endoscopy system 10 to control functions of endoscopy system 10 and view output of endoscope 14. Controller 16 can additionally be used to generate signals or other outputs from treating the anatomical region into which endoscope 14 is inserted. In examples, controller 16 can generate electrical output, acoustic output, a fluid output and the like for treating the anatomical region with, for example, cauterizing, cutting, freezing and the like.
Endoscope 14 can comprise insertion section 28, functional section 30 and handle section 32, which can be coupled to cable section 34 and coupler section 36.
Insertion section 28 can extend distally from handle section 32 and cable section 34 can extend proximally from handle section 32. Insertion section 28 can be elongate and include a bending section, and a distal end to which functional section 30 can be attached. The bending section can be controllable (e.g., by control knob 38 on handle section 32) to maneuver the distal end through tortuous anatomical passageways (e.g., stomach, duodenum, kidney, ureter, etc.). Insertion section 28 can also include one or more working channels (e.g., an internal lumen) that can be elongate and support insertion of one or more therapeutic tools of functional section 30. The working channel can extend between handle section 32 and functional section 30. Additional functionalities, such as fluid passages, guide wires, and pull wires can also be provided by insertion section 28 (e.g., via suction or irrigation passageways, and the like).
Handle section 32 can comprise knob 38 as well as ports 40. Knob 38 can be coupled to a pull wire extending through insertion section 28. Ports 40 can be configured to couple various electrical cables, fluid tubes and the like to handle section 32 for coupling with insertion section 28.
Imaging and control system 12, according to examples, can be provided on a mobile platform (e.g., cart 41) with shelves for housing light source 22, suction pump 26, image processing unit 42, etc. Alternatively, several components of imaging and control system 12 shown in
Image processing unit 42 and light source 22 can each interface with endoscope 14 by wired or wireless electrical connections. Imaging and control system 12 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 display unit 18. Imaging and control system 12 can include light source 22 to illuminate the anatomical region using light of desired spectrum (e.g., broadband white light, narrow-band imaging using preferred electromagnetic wavelengths, and the like). Imaging and control system 12 can connect (e.g., via an endoscope connector) to endoscope 14 for signal transmission (e.g., light output from light source, video signals from imaging system in the distal end, and the like).
Fluid source 24 can comprise 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 connectors (barb fittings, fluid seals, valves and the like). Imaging and control system 12 can also include drive unit 46, which can be an optional component. Drive unit 46 can comprise a motorized drive for advancing a distal section of endoscope 14, as described in at least PCT Pub. No. WO 2011/140118 A1 to Frassica et al., titled “Rotate-to-Advance Catheterization System,” which is hereby incorporated in its entirety by this reference.
In the example of
As can be seen in
Housing 52 can comprise accommodation space 53 that houses deflector 55. Instrument 63 can comprise forceps, a catheter, or the like that extends through lumen 62. A proximal end of deflector 55 can be attached to housing 62 at pin 618 provided to the rigid tip 21. A distal end of deflector 55 can be located below window 65 within housing 62 when deflector 55 is in the lowered, or un-actuated, state. The distal end of deflector 55 can at least partially extend out of window 65 when deflector 55 is raised, or actuated, by wire 57. Instrument 63 can slide on angled ramp surface 51 of deflector 55 to initially deflect the distal end of instrument 63 toward window 65. Angled ramp surface 51 can facilitate extension of the distal portion of instrument 63 extending from window 65 at a first angle relative to the axis of lumen 62. Angled ramp surface 51 can include groove 69, e.g. a v-notch, to receive and guide instrument 63. Deflector 55 can be actuated to bend instrument 63 at a second angle relative to the axis of lumen 62, which is closer to perpendicular that the first angle. When wire 57 is released, deflector 55 can be rotated, e.g., counter-clockwise, back to the lowered position, either by pushing or relaxing of wire 57.
In the example of
As can be seen in
Both side-viewing endoscope camera module 50 of
As mentioned, the present inventors have recognized that conventional endoscopes, particularly, duodenoscopes, can include elevator sections that comprise elaborate and intricate constructions that can be expensive and difficult to clean. The present inventors have developed solutions to these and other problems by developing endoscopes that can have attachment mechanisms and systems that facilitate simple and easy-to-operate attachment and detachment of camera modules and control modules that can be separated from a disposable insertion section sheath. As such, the camera and control modules can include high-quality or high-performance components that can be reused and enveloped in an easy to clean housing. For example, the cameral module can include a 4K, high-imaging unit that can be contained in a sealed container having cut-outs or windows for imaging and illumination lenses, thereby eliminating or reducing cracks and crevices for biological matter to become lodged. Furthermore, the control module can include a multitude of inputs for fixed or programmable control of functional module outputs, such as buttons or a touchscreen connected to a programmable computer system including, at least, a processor and memory. Furthermore, the control module can be encapsulated for easy cleaning and can wirelessly communicate with the functional module so to be operable from a sterile or non-sterile environment.
Functional module 102 can comprise functional module 30, camera module 50, camera module 150 (
Insertion section module 104 can comprise a tubular element, sheath or shaft upon and within which functional module 102 can be mounted for insertion into anatomy of a patient.
Navigation and control module 106 can comprise handle section 32, cable section 34 and coupler section 36 of
In examples, functional module 102 can comprise camera module 150 as described herein, or the camera modules of the endoscopes described in U.S. provisional patent application 63/024,674 filed on May 14, 2020, titled, “Endoscope with a Low-Profile Distal Section,” the entire contents of which is hereby incorporated by reference.
In examples, insertion section module 104 can comprise insertion section 28, which can be configured to include one or more of the sheath and shaft components of U.S. provisional patent application 63/017,901 filed on Apr. 30, 2020, titled, “Insertion Sheath for Modular Endoscope with Detachable and Selectively Disposable Components,” the entire contents of which is hereby incorporated by reference.
As mentioned previously, components of endoscope 14 can be modular, as shown by modular endoscope 100 of
In certain advantageous aspects, the modular construction of endoscope 14 of
Accordingly, modular endoscopes 14 and 100 of
In examples, endoscope 100 of
Additionally, the connectors of the camera module and the navigation and the control module as well as the camera module and the navigation and the control module can be constructed of materials and engineered to reduce any ingress of biological materials and can optionally be constructed in a fluid-tight manner.
Modular endoscope 100 can be configured for either a “side-viewing” configuration (as shown in
Camera module 150 can be attached to insertion section module 104 of
Housing 152 can comprise a sturdy, fluid-tight enclosure can be formed to limit accumulation of biofilm or other biological substances during clinical use. In the illustrated examples, camera module 150 can include ports that permit passage of fluids, however, the remainder of housing 152 can be fluid-tight to reduce the chances of fluid ingress or egress, and also can not include seams or other crevices which have a tendency for accumulation of biological substances. In an example, housing 152 can comprise first shell 153A and second shell 153B that can be brought together at groove 154, such as via a snap fit coupling. A seal, such as an O-ring can be positioned in groove 154. Additionally, shells 153A and 153B can be fabricated of a clear or transparent material that can allow light to pass into and out of lenses 156 and 158, thereby avoiding external cracks and crevices where fluid can ingress into housing 152. Alternatively, shell 153A can be provided with ports for lenses 156 and 156 that can be sealed with O-rings. Accordingly, housing 152 of
Camera module 150 can be “self-contained.” For instance, detachable camera module 150 can include wireless communication circuit 162, rechargeable power source 164, imaging unit 166 and illumination unit 168 in operative communication with one another, as schematically illustrated in
Rechargeable power source 164 can include one or more batteries (e.g., Lithium ion) that can provide power for the entire duration of clinical procedures (e.g., up to about 8 hours, inclusive). Power source 164 can be “recharged” between use, during sterilization or reprocessing, as explained herein with reference to
Illumination unit 168 can include one or more lamps e.g., LED, as illustrated in
Imaging unit 166 can include one or more of a CCD or CMOS photosensitive element. Imaging unit 166 can be coupled to rechargeable power source 164 to provide power to imaging unit 166 for the duration of one or more clinical procedures. Output of imaging unit 166, e.g., still digital images or digital video, can be conveyed to wireless communication circuit 162 for transmission to devices and systems external to camera module 150.
Wireless communication circuit 162 can establish wireless communication between illumination unit 168, imaging unit 166, rechargeable power source 164, and any of endoscope control unit 16 (as seen in
In advantageous examples, the wireless signals can include data (e.g., scope identification such as serial number), camera module location in the anatomy (e.g., using Olympus Corporation's ScopeGuide technology), battery power remaining, strength of wireless signal, and images or video recorded by the imaging unit, and the like.
According to illustrative examples, wireless communication circuit 162 can include transponders or beacons that can communicate using well-established wireless communication protocols, such as 3G, 4G, 5G, Bluetooth®, and wireless internet protocols such as 802.11 and WiFi. In advantageous aspects, Bluetooth can be used to achieve desirable data transfer rates and low power consumption rates.
Additionally, wireless communication circuit 162 can also include near-field communication (NFC or radiofrequency) chips or devices to communicate with other modules (e.g., an NFC chip provided on a insertion section module having memory) to validate identification data (e.g. serial number of the insertion section module) stored in the memory. Wireless communication circuit 162 can transmit the identification data collected from insertion section module 104 to control unit 16 and verify that insertion section module 104 is appropriate (e.g., compatible with camera module 150) and ready for use. In addition, such examples can ensure that a correct insertion section module 104 has been used for a particular clinical procedure. In such cases, control unit 16 can be programmed (e.g., using computer readable instructions) to:
According to advantageous aspects, in examples where an NFC chip is used, the above steps can be performed before the insertion and coupling of camera module 150 to insertion section module 104. For example, wireless communication circuit 162 of camera module 150 can interrogate a wireless communication circuit of insertion section module 104 and the wireless communication circuit of insertion section module 104 can communicate with control unit 16 of imaging and control system 12 to, for example, ensure that only compatible insertion section modules 104 are used with camera module 150 and are suitable for the intended medical procedure.
In addition, or in the alternative, in certain examples, camera module 150 can be constructed as being similar to the Olympus Corporation's Endocapsule endoscopy system.
The attachment mechanisms of
Distal portion 202 of insertion section module 104 can comprise a tubular body defining lumen 206. Retention band 204 can comprise a loop, r partial loop, having first end 208A connected to distal portion 202 at attachment 210A and second end 208B connected to distal portion 202 at attachment 210B.
Retention band 204 can comprise a rigid or elastic member extending between first end 208A and second end 208B. Attachments 210A and 210B can comprise fixed or releasable connections between retention band 204 and distal portion 202. In examples, attachments 210A and 210B can comprise metallurgical bonds (e.g., welds or solders), chemical bonds (e.g., adhesives or glues) or mechanical bonds (e.g., fasteners and pins).
In an example, retention band 204 can comprise an elastic band and attachments 210A and 210B can be fixed. As such, as shown in
In another example, retention band 204 can comprise a rigid band and one or both of attachments 210A and 210B can comprise releasable connections. In particular, one or each of attachments 210A and 210B can comprise a clasp, such as the one described with reference to
Retention clip 222 can comprise a spring bracket comprising base 224 and first and second ends 226A and 226B. Attachment mechanism 220 can comprise one or more retention clips 222 mounted to platform 228. Platform 228 can comprise a flange or hoop coupled to distal portion 202 upon which retention clips 222 can be mounted. Platform 228 can be attached to distal portion 202 by any suitable means, including via the use of fasteners, metallurgical bonding methods, glues and adhesives. Bases 224 of retention clips 222 can be secured to platform 228 such that ends 226A and 226B extend radially inward toward centerline 230. First and second ends 226A and 226B can be contoured to match the shape of housing 152 including groove 154. Retention clips 22 can be actuated (e.g., by manual force during attachment of camera module 150) onto groove 154 in housing 152 of camera module 150 (as illustrated in
As can be seen in
Attachment mechanism 240 can comprise a hinged mechanism including base 242, fixed jaw 244 and movable jaw 246. Fixed jaw 244 can be rigidly secured to base 242. Fixed jaw 244 and moveable jaw 246 can be coupled by one or more devices acting as hinges and springs, such as hinges 248A and 248B at joint 250. In the illustrated example, hinges 248A and 248B can comprise elastic bands. Hinges 248A and 248B are shown in one side of jaws 244 and 246 and an analogous pair can be disposed on the opposed side of jaws 244 and 246. Fixed jaw 244 and moveable jaw 246 can comprise a holder or housing for receiving camera module 150 and, as such, can comprise an internal volume that conforms or substantially conforms to the outer shape of housing 152 of camera module 150. Hinges 248A and 248B can have opposite ends connected to fixed jaw 244 and moveable jaw 246, respectfully. Hinges 248A and 248B can comprise both spring properties and hinge properties. For example, hinges 248A and 248B can comprise elastic bands that can be stretched to position moveable jaw 246 in the extended or expanded position of
As can be seen in
Attachment mechanism 280 can comprise any of the attachment mechanisms disclosed or contemplated herein, such as attachment mechanisms 200, 220, 240 and 260. In the illustrated examples, threaded socket 284 can comprise a circular ring into which distal portion 202 can be inserted via threaded engagement. As such threaded socket 284 can comprise internal threading 288 (shown in phantom in
In examples where endoscope 100 is a duodenoscope, distal portion 202 of insertion section module 104 can be provided with an elevator portion (e.g., elevator 54 of
Housing 152 of camera module 150 can be positioned in the various attachment mechanisms disclosed herein in different orientations relative to central axis CA, as can be seen in
In optional examples, a protective sheath can be placed around camera module 150 to further reduce ingress of biological substances into the camera module. The protective sheath can comprise a flexible bag that can be positioned over camera module 150 and attachment mechanism 280 and secured to distal portion 202. In examples, the protective sheath can be secured by threaded engagement 282. In other examples, the protective sheath can comprise a hard-sided structure matching the shape of attachment mechanism 280 that is secured by force for or snap fit at threaded socket 284.
In examples, attachment mechanism 280, as well as the other attachment mechanisms disclosed herein, can include fluid outlets 76 that can connect to fluid lines 89 via conduits 292 (only one within attachment mechanism. Additionally, distal section 202 can comprise lumen 82 through which other components or capabilities can be inserted to connect to attachment mechanism 280. In other examples, distal section 202 can be sealed off, such as for use with fully independently functional camera modules.
According to some examples, navigation and control module 106 (
Navigation and control module 300 can be detachably coupled to insertion section module 104, such as via coupler 314. In addition, navigation and control module 300 can be fluidly isolated from insertion section module 104, and can therefore be in a sterile environment for reuse after using in a single clinical procedure. For examples, holes in housing 315 for each of the illustrated joysticks and buttons can be sealed with an O-ring or the like. In additional examples, the illustrated buttons can comprise portions of housing 315 connected thereto by monolithic membranes in housing 315. Housing 315 can be ergonomically shaped to allow a user to grip module 300 and easily manipulate joysticks 302A and 302B and buttons 304A-310B. Although module 300 is illustrated as having joysticks and buttons, module 300 can be configured to include other operator inputs, such as triggers and gesture controllers (e.g., gyroscopes).
As shown in
Joystick 302A can be configured to control the directionality of insertion section module 104, such as by acting upon pull wires. Joystick 302A can replace the up-down and right-left angulation knobs (e.g., knob 38 of
With continued reference to
Module 300 can also include additional buttons for facilitating other endoscope functionalities, including programmable functionalities (e.g., capture image, record video, open suction valve, open irrigation valve, close suction valve, close irrigation valve, and the like). Button 308A can be configured to command camera module 150 to operate imaging unit 166. Button 308B can be configured to command camera module 150 to operate illumination unit 168. Furthermore, buttons 308A-308D can be programmable, or can provide angulation locks for the auxiliary scope, similar to the buttons 304A-304D. Additional buttons can be provided to improve ergonomic comfort for the operator e.g., quick lock buttons positioned near the joystick driver to easily lock the scope in the current location without requiring the operator to remove their fingers from the joystick driver, or additional buttons for elevator functionality in duodenoscopes.
As shown in
While
Navigation and control module 400 can comprise a touchscreen display comprising housing 402 and touchscreen 404. Control module 400 can include a wireless communication device to facilitate wireless communication 405 with camera module 150 of module endoscope 100 and one or more systems, such as, a motorized driver for self-advancement of endoscope 100 upon receiving instructions from the operator 405, provided by one or more “gestures” 406 on touchscreen 404.
The operator can interact with touchscreen 404 to send instructions to endoscope 100, including camera module 150, for the performance of one or more endoscopy functions. For instance, the operator can interact with touchscreen 404 the endoscope using one or more gestures provided on the touchscreen display, including, “pan” gesture (horizontal or vertical direction). Upon receiving the gesture, touchscreen 404 can communicate with imaging and control system 12 (e.g., including drive motor 46) to start advancing the endoscope in a direction corresponding to the movement of the operator's finger, provided during the finger gesture. Additionally, “pinch” to zoom and “tap” to focus gestures can be used.
Control module 400 can be programmed so that touchscreen 404 can display one or more indicators or interface icons. In the illustrated example, touchscreen 404 can display battery icon 407, wireless toggle 408, power toggle 411, angulation lock toggle 412, illumination toggle 410, video record toggle 414 and still image toggle 416. Touchscreen 404 can also display navigation aids, such as imaging unit field of view 418 and anatomy diagram 420 with camera location indicator 422.
The operator can communicate with imaging and control system 12 (e.g., a motorized lens assembly for the objective lens) by tapping on touchscreen 404, to focus or refocus on an anatomical region. The operator can tap once on the “endoscope imaging unit: field of view” button 418 shown in
Other gestures can include tapping on the “record video” toggle 414, tapping on “record still image” toggle 416 to take a single image of the endoscope field of view, press and hold on “record still image” toggle 416 to take a screen shot of the current screen for medical records, or to take a series of shots. In addition, gestures can include tapping on various regions of the interactive graphical user interface, such as angulation toggle 412 for angulation lock, adjusting intensity of light output provided by illumination module 168 using illumination toggle 410, and toggle wireless communication on/off with wireless toggle 408, etc.
Touchscreen 404 can include an interactive graphical user interface, enabling the operator to receive different types of data (e.g., scope specifications such as serial number, type, manufacturer, etc., location of the camera module overlaid on an anatomy map) battery power left on the camera module and the like). Anatomy diagram 420 can be provided by medical imaging uploaded to control module 400 or can comprise generic anatomical diagrams to generally indicate the shape of the anatomy. Location indicator 422 can be provided by a locator provided on wireless camera module 150, such as a locator useable with a surgical tracking system or one that can triangulate the position of camera module 150 within a tracking field.
In alternative examples, machine 1700 can operate as a standalone device or can be connected (e.g., networked) to other machines. In a networked deployment, machine 1700 can operate in the capacity of a server machine, a client machine, or both in server-client network environments. In an example, machine 1700 can act as a peer machine in peer-to-peer (P2P) (or other distributed) network environment. 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 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.
Machine (e.g., computer system) 1700 can include hardware processor 1702 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof), main memory 1704 and static memory 1706, some or all of which can communicate with each other via interlink (e.g., bus) 1708. Machine 1700 can further include display unit 1710, alphanumeric input device 1712 (e.g., a keyboard), and user interface (UI) navigation device 1714 (e.g., a mouse). In an example, display unit 1710, input device 1712 and UI navigation device 1714 can be a touch screen display. Machine 1700 can additionally include storage device (e.g., drive unit) 1716, signal generation device 1718 (e.g., a speaker), network interface device 1720, and one or more sensors 1721, such as a global positioning system (GPS) sensor, compass, accelerometer, or other sensor. Machine 1700 can include 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.). Input device 1712 can include wireless toggle 408, power toggle 411, angulation lock toggle 412, illumination toggle 410, video record toggle 414 and still image toggle 416. Output controller 1728 can control operation of motors for advancement of insertion section module 104 as described herein. Display unit 1710 can comprise touchscreen 404. Sensors 1721 can comprise force sensors for sensing the advancement of insertion section module 104. Sensors 1721 can also comprise locations sensors from wireless camera module 150.
Storage device 1716 can include 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. Instructions 1724 can also reside, completely or at least partially, within main memory 1704, within static memory 1706, or within hardware processor 1702 during execution thereof by machine 1700. In an example, one or any combination of hardware processor 1702, main memory 1704, static memory 1706, or storage device 1716 can constitute machine readable media.
While 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 the one or more instructions 1724. The term “machine readable medium” can include any medium that is capable of storing, encoding, or carrying instructions for execution by machine 1700 and that cause machine 1700 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 can include solid-state memories, and optical and magnetic media.
Instructions 1724 can further be transmitted or received over communications network 1726 using a transmission medium via 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), mobile telephone networks (e.g., cellular networks), 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 802.16 family of standards known as WiMax®), IEEE 802.15.4 family of standards, peer-to-peer (P2P) networks, among others. In an example, network interface device 1720 can include one or more physical jacks (e.g., Ethernet, coaxial, or phone jacks) or one or more antennas to connect to communications network 1726. In an example, network interface device 1720 can 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 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 machine 1700, and includes digital or analog communications signals or other intangible medium to facilitate communication of such software. Interface device 1720 can be configured to communicate with wireless communication circuit 162 of camera module 150, wireless communication unit 172 of control unit 16, a wireless communication unit of insertion section module 104, wireless communication unit 344 and other wireless communication devices described herein.
Examples disclosed herein can result in many advantages, including a modular construction, improved ergonomics, and self-contained camera modules for an endoscope.
At step 904, a particular condition of the patient can be identified as needing interaction from a particular therapy or evaluative procedure. For example, a particular organ or anatomic region can be identified as needing a specific intervention or evaluation.
At step 906, a particular treatment plan can be developed to address the condition identified at step 904. The treatment plan can include selection of a therapy to be performed, such as ablation, freezing, cauterizing, cutting, attaching and the like. The treatment plan can also include a plan for performing a surgical technique, such as instructions for delivering the selected therapy to the particular organ or anatomic regions, such as by using a camera-enabled endoscope.
At step 908, components of a medical device to deliver the selected therapy can be selected. For example, a particular treatment module can be selected to provide the selected therapy, a particular sheath or shaft can be selected to deliver the treatment module, and a particular control module can be selected to control operation of the modular medical device. Features and characteristics of the selected sheath or shaft can be selected, such as the number of delivery lumens needed to provide the treatment, guidance and steering capabilities needed for the selected treatment plan and therapy. Likewise, a camera module and a control module can be selected to facilitate guiding of the treatment module and viewing of the anatomic region or organ.
At step 910, the selected components of step 908 can be assembled. The selected components can be assembled at a medical facility where the procedure is to be performed, at step 912A. For example, the modular components can be user-assembled. In particular, a camera module can be attached using an attachment mechanism, such as one of the attachment devices described herein, e.g., attachment devices 200, 220, 240, 260 and 280. Additionally, a control module can be selected, such as module 300 or module 400. The selected components can be assembled at a manufacturing facility, at step 912B.
At step 914, the procedure planned for at step 906 can be performed with the medical device assembled at step 910.
At step 916, the assembled medical device used in the procedure at step 914 can be disassembled. The medical device can be disassembled at the medical facility of step 912A or can be sent offsite to be disassembled at the manufacturing facility of step 912B or another repurposing facility. The modular components can be user-disassembled by operating an attachment mechanism.
At step 918, the disassembled components can be sorted into components that can be disposed of at step 920A and components that can be reused at step 920B.
At step 922, the disposable components can be disposed of, such as by being destroyed or discarded. The disposable components can comprise a disposable insertion sheath.
At step 924, the reusable components of step 920B can be cleaned and sterilized for reuse. The reusable components can comprise a detachable camera module and a detachable control module. As such, the cleaned and sterilized components can be returned to inventory of the medical facility or manufacturing facility to be used in additional procedures. In examples, camera module 150 and control module 300 can be cleaned and sterilized using sterilization apparatus 500.
Example 1 can include or use subject matter such as a modular endoscopy system that can comprise a first modular section comprising control and navigation functionality, and a second modular section user-detachably connectable to the first modular section via an attachment mechanism, the second modular section being patient insertable, wherein the first modular section is positionable at a proximal end section of the second modular section and is configured to steer and bend a portion of the second modular section.
Example 2 can include, or can optionally be combined with the subject matter of Example 1, to optionally include a second modular section that includes an insertion section module that can comprise an elongate working section.
Example 3 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 or 2 to optionally include a third modular section that is user-detachably connectable to the second modular section.
Example 4 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 3 to optionally include a third modular section that comprises an imaging and illumination module operatively connectable to a distal portion the elongate working section.
Example 5 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 4 to optionally include a distal end section of the second modular section that comprises an elevator mechanism configured to orient and support one or more therapeutic tools extended through the second modular section.
Example 6 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 5 to optionally include navigation and control functionality that is configured to operate the elevator mechanism.
Example 7 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 6 to optionally include a first modular section that can further comprises a rechargeable power source configured to provide power to the navigation and control functionality.
Example 8 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 7 to optionally include a first modular section that further comprises a wireless communication circuit configured to send or receive data or instructions from the second modular section or an imaging and control system.
Example 9 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 8 to optionally include, when attached, a first modular section and a second modular section that are generally co-axially positioned along a longitudinal axis of the second modular section.
Example 10 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 9 to optionally include an attachment mechanism that comprises a socket for coupling angulation wires.
Example 11 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 10 to optionally include a first modular section that comprises a joystick.
Example 12 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 11 to optionally include a joystick that comprises one or more devices for manipulating angulation wires.
Example 13 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 12 to optionally include a joystick that comprises one or more lock buttons to inhibit movement of the one or more devices for manipulating angulation wires.
Example 14 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 13 to optionally include a joystick that further comprises one or more programable buttons.
Example 15 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 14 to optionally include a first modular section that further comprises a force sensor for sensing force applied to an angulation wire.
Example 16 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 15 to optionally include a haptic feedback device configured to vibrate the joystick based on feedback from the force sensor.
Example 17 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 16 to optionally include a first modular section that comprises a computing device comprising a touchscreen display.
Example 18 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 17 to optionally include a computing device that comprises a wireless communication device.
Example 19 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 18 to optionally include a computing device that comprises non-transitory memory having instructions stored therein for gesture control of an endoscope in communication with the computing device.
Example 20 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 19 to optionally include a first modular section that comprises a first near-field communication device, and a second modular section that comprises a second near-field communication device, wherein near-field communication can be established between the first modular section and the second modular section.
Example 21 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 20 to optionally include a second modular section that includes memory having stored therein one or more of manufacturer information, model number information and serial number information.
Example 22 can include or use subject matter such as a method of using a modular endoscopy system that can comprise attaching a first modular section of the modular endoscopy system to a second modular section of the modular endoscopy system, positioning at least a portion of the modular endoscopy system within a patient, steering a portion of the second modular section to an anatomy location of the patient via the first modular section, removing the modular endoscopy system from the patient, and detaching the second modular section from the first modular section after removal of the modular endoscopy system from the patient.
Example 23 can include, or can optionally be combined with the subject matter of Example 22, to optionally include assembling the first and second modular components of the modular endoscopy system at a surgical facility.
Example 24 can include, or can optionally be combined with the subject matter of one or any combination of Examples 22 or 23 to optionally include a first modular component that comprises an insertion section module, and a second modular component that comprises a control module.
Example 25 can include, or can optionally be combined with the subject matter of one or any combination of Examples 22 through 24 to optionally include disposing of the insertion section module, and cleaning and sanitizing the control module.
Example 26 can include, or can optionally be combined with the subject matter of one or any combination of Examples 22 through 25 to optionally include cleaning and sanitizing the control module by positioning the camera module within a sterilization apparatus comprising an enclosure having an ultraviolet light source and a fluid jet.
Example 27 can include, or can optionally be combined with the subject matter of one or any combination of Examples 22 through 26 to optionally include reusing the cleaned and sanitized reusable components in a subsequent medical procedure.
Example 28 can include, or can optionally be combined with the subject matter of one or any combination of Examples 22 through 27 to optionally include positioning at least the portion of the modular endoscopy system within the patient by inserting a portion of the insertion section module into the patient to position while holding the control module.
Example 29 can include, or can optionally be combined with the subject matter of one or any combination of Examples 22 through 28 to optionally include establishing a near-field communication link between the first modular section and the second modular section.
Example 30 can include, or can optionally be combined with the subject matter of one or any combination of Examples 22 through 29 to optionally include a second modular section that includes memory having stored therein one or more of manufacturer information, model number information and serial number information.
Example 31 can include, or can optionally be combined with the subject matter of one or any combination of Examples 22 through 30 to optionally include identifying a specific treatment for the patient, and selecting the first modular section capable of treating the patient with the identified treatment.
Example 32 can include or use subject matter such as a navigation and control module for an endoscope that can comprise an ergonomically shaped housing, a joystick mounted to the housing in an articulable manner, and an angulation wire connected to the joystick.
Example 33 can include, or can optionally be combined with the subject matter of Example 32, to optionally include a joystick that comprises a pivot shaft, a driver connected to a first end of the pivot shaft, and a gear connected to a second end of the pivot shaft, wherein one or more angulation wires are connected to the gear.
Example 34 can include, or can optionally be combined with the subject matter of one or any combination of Examples 32 or 33 to optionally include a pivot shaft is configured to pivot about a pivot axis to push and pull the one or more angulation wires.
Example 35 can include, or can optionally be combined with the subject matter of one or any combination of Examples 32 through 34 to optionally include a pivot shaft that is configured to rotate about a rotation axis to push and pull the one or more angulation wires.
Example 36 can include, or can optionally be combined with the subject matter of one or any combination of Examples 32 through 35 to optionally include a lock button configured to inhibit movement of the pivot shaft.
Example 37 can include, or can optionally be combined with the subject matter of one or any combination of Examples 32 through 36 to optionally include a coupler connected to the angulation wire.
Example 38 can include, or can optionally be combined with the subject matter of one or any combination of Examples 32 through 37 to optionally include a force sensor coupled to the angulation wire.
Example 39 can include, or can optionally be combined with the subject matter of one or any combination of Examples 32 through 38 to optionally include a haptic feedback device coupled to the angulation wire.
Example 40 can include, or can optionally be combined with the subject matter of one or any combination of Examples 32 through 39 to optionally include a wireless communication device located in the housing.
Example 41 can include, or can optionally be combined with the subject matter of one or any combination of Examples 32 through 40 to optionally include a plurality of buttons configured to control operation of a camera module connected to the endoscope.
Example 42 can include or use subject matter such as a method of controlling an endoscope that can comprise coupling an insertion section module of the endoscope to a motorized drive device, establishing a wireless communication connection between the motorized drive device and a navigation and control module, executing gestures on a touchscreen of the navigation and control module to control axial movement of the insertions section module with the motorized drive device.
Example 43 can include, or can optionally be combined with the subject matter of Example 42, to optionally include controlling operation of a wireless camera module coupled to a distal end of the insertion section module with the touchscreen of the navigation and control module.
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 embodiments in which the invention 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 inventor also contemplates examples in which only those elements shown or described are provided. Moreover, the present inventor also contemplates 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.
In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls.
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 this document, 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, composition, formulation, 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.
Method examples described herein can be machine or computer-implemented at least in part. Some examples can include a computer-readable medium or machine-readable medium encoded with instructions operable to configure an electronic device to perform methods as described in the above examples. An implementation of such methods can include code, such as microcode, assembly language code, a higher-level language code, or the like. Such code can include computer readable instructions for performing various methods. The code may form portions of computer program products. Further, in an example, the code can be tangibly stored on one or more volatile, non-transitory, or non-volatile tangible computer-readable media, such as during execution or at other times. Examples of these tangible computer-readable media can include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or sticks, random access memories (RAMs), read only memories (ROMs), and the like.
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 embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to comply with 37 C.F.R. § 1.72(b), to allow the reader to quickly ascertain the nature of the technical disclosure. It 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 embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.
This patent application claims the benefit of priority to U.S. Provisional Patent Application Ser. No. 62/951,157 filed Dec. 20, 2019 tided “MODULAR ENDOSCOPE WITH DETACHABLE AND SELECTIVELY DISPOSABLE COMPONENTS”; U.S. Provisional Patent Application Ser. No. 63/031,312 filed May 28, 2020 titled “ENDOSCOPE WITH DETACHABLE CAMERA MODULE”; and U.S. Provisional Patent Application Ser. No. 63/031,316 filed May 28, 2020 titled “ENDOSCOPE WITH DETACHABLE HANDLE MODULE”, the entire contents of which are hereby incorporated by reference.
Number | Date | Country | |
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62951157 | Dec 2019 | US | |
63031312 | May 2020 | US | |
63031316 | May 2020 | US |