Disposable device with integrated visual capabilities

Abstract

An integrated disposable device with visual capabilities is provided. The device may comprise: an endoscope comprising: i) a disposable elongate member comprising a proximal end and a distal end; and ii) a camera module located at the distal end, and the proximal end being removably attached to a support member; and one or more disposable instruments integrated into the endoscope, and the device is configured to perform functions of both the endoscope and the one or more disposable instruments.

Description

[0001] This application is a divisional application of the Chinese patent application with the application date of January 24, 2020, application number 202080023462.9, and invention name “Disposable device with integrated visual capabilities” (the corresponding PCT application has the application date of January 24, 2020 and application number PCT / US2020 / 014959).

[0002] Cross Reference to Related Applications

[0003] This application claims the benefit of U.S. Provisional Application No. 62 / 796,477, filed January 24, 2019, which is incorporated herein by reference. Background Art

[0004] Endoscopes have a wide range of applications in the diagnosis and treatment of various conditions, such as medical conditions. In many cases, endoscopes may be reusable and may require cleaning procedures, disinfection, and sterilization, which can be demanding on the endoscope and complicate endoscope design and the procedures in which such endoscopes are used.

[0005] Recognized herein are devices and systems comprising endoscopes that can be disposable and do not require extensive cleaning procedures. Furthermore, a need is recognized for devices comprising an endoscope and a disposable instrument that can be integrated with the endoscope and configured to perform the functions of both the endoscope and the instrument as a single unit. Provided herein are various variations of such devices, as well as methods of using such devices. Summary of the Invention

[0006]

[0006] The present invention recognizes a need for systems and methods that allow surgical or diagnostic procedures to be performed with improved reliability and cost-efficiency.The systems and methods can be minimally invasive.

[0007] In one aspect, the present disclosure provides an apparatus comprising: (a) an endoscope comprising: i) a disposable elongated member comprising a proximal end and a distal end; and ii) a camera module located at the distal end, wherein the proximal end is removably attached to a support member; and (b) one or more disposable instruments integrated into the endoscope. The apparatus can be configured to perform the functions of both the endoscope and the one or more disposable instruments.

[0008] In some embodiments, the distal end is articulated with two or more degrees of freedom. In some embodiments, at least one of the one or more disposable instruments can be integrated into the endoscope via a permanent connection to the distal end. In some embodiments, one or more pull wires can be integrated into the wall of the elongated member.

[0009] In some embodiments, the one or more disposable instruments are selected from the group consisting of: a morcellator, scissors, a needle, a lighting source, a laser, a balloon, an implant / stent delivery device, a suturing device, a laser fiber, a grasper, a snare, a ring, and a barrel. In some embodiments, the one or more disposable instruments may further include other instruments.

[0010] In some embodiments, there can be substantially no relative movement between the camera module and one or more disposable instruments. In some embodiments, the camera module and one or more disposable instruments can be permanently integrated into the endoscope, and there can be substantially no relative movement between the camera module and the additional disposable instruments.

[0011] In some embodiments, the camera module can be configured to provide a static view of one or more disposable instruments. In some embodiments, the camera module can be fixed relative to the one or more disposable instruments.

[0012] In some embodiments, the distal end includes both endoscopic and instrument functions.

[0013] In some embodiments, the support member can include a mechanical interface configured to control articulation of the distal end of the endoscope or operation of one or more instruments. In some embodiments, the mechanical interface can include a drive mechanism for one or more pull wires attached to the distal end. In some embodiments, the mechanical interface can include a mechanism for manipulating one or more disposable instruments.

[0014] In some embodiments, the device may further include an interface between the distal portion and the support member. In some embodiments, the support member may include or be a robotic arm. Alternatively, the support member may be coupled to a robotic arm. In some embodiments, the support member may be reusable. In some embodiments, the support member may be configured to control functions of the endoscope and one or more instruments.

[0015] In some embodiments, the support member can be a handheld device. The handheld device can include or be or be referred to as a handpiece.

[0016] In some embodiments, the endoscope can be disposable. In some embodiments, one or more disposable instruments can include a morcellator. In some embodiments, the morcellator can be located at the distal end. In some embodiments, the camera module can be located proximate to the morcellator.

[0017] In some embodiments, one or more disposable instruments can include an illumination source. In some embodiments, the illumination source can be positioned proximate to the camera. In some embodiments, the illumination source can include an illumination fiber or one or more light emitting diodes (LEDs).

[0018] In some embodiments, the endoscope can include a channel. In some embodiments, the pulverizer includes an outer tube and an inner tube. In some embodiments, the relative motion between the pulverizer and the camera module can be substantially zero. In some embodiments, the device can be configured to provide a static view of the pulverizer. In some embodiments, the pulverizer is pre-bent. In some embodiments, the camera module can be positioned in a neck region of the pulverizer. In some embodiments, the camera module can be positioned in other regions. In some embodiments, the pulverizer can include an axis. In some embodiments, the camera module and the pulverizer can each include an axis. In some embodiments, one or more axes can be articulated with two or more degrees of freedom. In some embodiments, the axis can include one or more pull wires.

[0019] In some embodiments, one or more disposable instruments can include an illumination source and a morcellator. In some embodiments, the illumination source can be positioned adjacent to the camera module. In some embodiments, the illumination source can be positioned near the camera module.

[0020] In some embodiments, one or more disposable instruments can include an inflatable tip. In some embodiments, the inflatable tip can include an inflatable balloon. In some embodiments, at least one of the one or more disposable instruments can include a shaft and the distal portion of the shaft can be connected to the distal end. In some embodiments, the inflatable tip can include at least one of a structural tube and an internal reinforcement. In some embodiments, the device can be configured to provide a static view of the inflatable tip. In some embodiments, there is substantially no relative movement between the inflatable tip and the camera module.

[0021] In some embodiments, one or more disposable instruments can include an implant / stent delivery device. In some embodiments, the implant / stent delivery device can be configured to perform sinus surgery. In some embodiments, the device can include an implant / stent delivery device and an illumination source. In some embodiments, the device can further include a channel. In some embodiments, the device can further include an implant / stent delivery push mechanism. In some embodiments, the implant delivery device can be configured to deliver a prostate implant.

[0022] In one aspect, the present disclosure provides a method comprising: providing an endoscope comprising a disposable elongated member comprising a proximal end and a distal end, and a camera module at the distal end, wherein the proximal end is removably attachable to a support member; providing one or more disposable instruments; and integrating the one or more disposable instruments into the endoscope to form an integrated single device.

[0023] In some embodiments, the method may further include using an integrated single device to perform the functions of an endoscope and one or more disposable instruments.

[0024] In some embodiments, integrating one or more disposable instruments into an endoscope to form an integrated single device may not require user assembly. In some embodiments, the integrated single device may be provided in a sterilized packaging. In some embodiments, the method may further include selecting at least one disposable instrument from the one or more disposable instruments to be integrated before performing the function.

[0025] In some embodiments, one or more disposable instruments can be integrated into the endoscope using an adhesive material. In some embodiments, the adhesive material can be biocompatible. In some embodiments, one or more disposable instruments can be integrated into the endoscope via one or more mechanical connection features. In some embodiments, the one or more mechanical connection features can include a quick release mechanism. In some embodiments, the one or more mechanical connection features can include a snap-fit ​​mechanism. In some embodiments, the method can eliminate the need for post-operative cleaning of the device. In some embodiments, integrating the one or more disposable instruments into the endoscope includes using one or more locks.

[0026] In some embodiments, integrating one or more disposable instruments into the endoscope can include using a mechanism or tool selected from the group consisting of: heating, welding, gluing, friction, snapping, locking, clamps, tracks, mechanical deformation, bonding with adhesive epoxy, glue, biocompatible glue, curing with light, brazing, soldering, mechanical fastening, interlocking connection and flange.

[0027] In one aspect, the present disclosure provides an integrated disposable (or single-use) device having at least one integrated disposable instrument. The device may include visual capabilities provided by a camera module (such as a disposable camera module at the distal end of a disposable endoscope). In some embodiments, the device can be completely disposable. The device may include a disposable endoscope comprising a distal end and a proximal end and a camera module at the distal end. The proximal end of the endoscope can be configured to be connected to a support member, such as a handheld device or a robotic arm. The endoscope and camera module can be disposable. One or more disposable instruments can be integrated into the endoscope, and the endoscope can be configured to perform a desired procedure (such as a surgical procedure inside a subject's body) while the endoscope provides a view of the surgical site and instruments through the camera module. In some embodiments, the endoscope, camera module, and instrument can all be disposable and can be integrated together to create a combined (or integrated) single device that can be configured to perform the functions of an endoscope and one or more disposable instruments and can be completely disposable. The present disclosure also provides methods for making and using such devices for various applications (such as medical and / or surgical applications). The devices can be disposable, thereby eliminating the need for post-operative cleaning and simplifying endoscope design. The devices and methods provided herein can have advantages such as sterilizability, reduced cost, smaller overall size of the device compared to when the instrument and endoscope are not integrated into a single device, improved patient comfort, better usability, and simpler and more streamlined workflows.

[0028] INCORPORATION BY REFERENCE

[0029] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The novel features of the present invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description, which sets forth illustrative embodiments in which the principles of the present invention are utilized, and the accompanying drawings, which are as follows:

[0031] FIG. 1 An example apparatus 100 according to some embodiments of the present disclosure is schematically illustrated.

[0032] FIG. 2A and FIG. 2B An example of an alternative distal portion of a disposable integrated device with an integrated camera module is shown.

[0033] FIG. 3 An example of a proximal portion of a disposable integrated device with a camera module is shown.

[0034] FIG. 4A is a device that can be used to deliver implants into the prostate.

[0035] FIG. 4B is a device that can be used to deliver high temperature water vapor into the prostate.

[0036] FIG. 5A is a device that can be used to deliver implants within the ducts of the prostate.

[0037] FIG. 5B is a device that can be used to deliver different types of implants within the ducts of the prostate.

[0038] FIG. 6A and FIG. 6B An example of a proximal end and support member is shown that can include buttons, electrical interfaces, mechanical interfaces, fluid management interfaces, and other parts and pieces on the support member.

[0039] FIG. 7 An example of a device is shown in FIG. 1 Another example of a device is shown in

[0040] FIG. 8 An example of a combined device architecture that includes a scope, a camera, and components for controlling the instrument is shown.

[0041] FIG. 9 An example of a device with an integrated morcellator is shown.

[0042] FIG. 10 An example of a device with an integrated inflatable tip is shown.

[0043] FIG. 11 An example of a combined implant / stent delivery device is shown.

[0044] FIG. 12 An example of a combined suturing device is shown.

[0045] FIG. 13 An example of a combined instrument is shown.

[0046] FIG. 14A to FIG. 14E An example of a proximal end design of an integrated device and support member is shown.

[0047] FIG. 15 An example of a distal portion of a disposable integrated device with vision capabilities is shown. A camera module is positioned in the channel of the disposable device.

[0048] FIG. 16A andFIG. 16B An example of the distal portion of a disposable integrated device with vision that can be used to pulverize tissue under direct visualization is shown.

[0049] FIG. 17A is an example of a distal portion of a disposable device with integrated vision that can be used to deliver electrocautery to tissue.

[0050] FIG. 17B is an example of a distal portion of a disposable or single-use device with integrated vision (or an integrated camera module) that can be used to grasp tissue or deliver an IUD.

[0051] FIG. 18 An example robotic arm according to the apparatus and methods of the present disclosure is shown. DETAILED DESCRIPTION

[0052] Whenever the term "at least," "greater than," or "greater than or equal to" precedes the first value in a series of two or more values, the term "at least," "greater than," or "greater than or equal to" applies to each of the values ​​in the series. For example, greater than or equal to 1, 2, or 3 is equivalent to greater than or equal to 1, greater than or equal to 2, or greater than or equal to 3.

[0053] Whenever the term "not greater than," "less than," or "less than or equal to" precedes the first value in a series of two or more numerical values, the term "not greater than," "less than," or "less than or equal to" applies to each value in the series. For example, less than or equal to 3, 2, or 1 is equivalent to less than or equal to 3, less than or equal to 2, or less than or equal to 1.

[0054] As used herein, a processor includes one or more processors, such as a single processor, or multiple processors of a distributed processing system, for example. A controller or processor as described herein generally includes a tangible medium storing instructions to implement the steps of a process, and the processor may include, for example, one or more of a central processing unit, a programmable array logic, a gate array logic, or a field programmable gate array. In some cases, one or more processors may be a programmable processor (e.g., a central processing unit (CPU) or a microcontroller), a digital signal processor (DSP), a field programmable gate array (FPGA), and / or one or more advanced RISC machine (ARM) processors. In some cases, one or more processors may be operably coupled to a non-transitory computer-readable medium. A non-transitory computer-readable medium may store logic, code, and / or program instructions that may be executed by one or more processor units to perform one or more steps. A non-transitory computer-readable medium may include one or more storage units (e.g., removable media or external storage devices, such as SD cards or random access memories (RAM)). One or more methods or operations disclosed herein may be implemented in a hardware component or a combination of hardware and software (such as, for example, an ASIC, a special-purpose computer, or a general-purpose computer).

[0055] As used herein, the terms distal and proximal may generally refer to a position with reference to the device and may be as opposed to an anatomical reference. For example, a distal position of a bronchoscope or catheter may correspond to a proximal position of an elongated member of a patient, and a proximal position of a bronchoscope or catheter may correspond to a distal position of an elongated member of a patient.

[0056] Endoscopes are widely used to examine the interior of anatomical structures of subjects, such as animals and human subjects. Subjects can include animals, such as pigs, mice, dogs, mammals, rodents, monkeys, and other animals. Subjects can include human subjects, such as patients. The methods and systems provided herein can be used to diagnose and / or treat subjects and / or the parts of subjects.

[0057] Endoscopes are traditionally manufactured for reusability, which may require thorough cleaning, disinfection, and / or sterilization after each procedure. In most cases, cleaning, disinfection, and sterilization can be aggressive processes that kill bacteria and / or germs. Such procedures can also be harsh on the endoscope itself. Consequently, the design of such reusable endoscopes is often complex, particularly to ensure they can withstand such rigorous cleaning, disinfection, and sterilization procedures. Regular maintenance and repairs may also be necessary for such reusable endoscopes.

[0058] Many conventional endoscope designs can be complex, in part because the sterilization requirements of the endoscope for each procedure may require that the endoscope or endoscope parts be cleaned, disinfected, and / or sterilized before and / or after each procedure. The endoscope may be reprocessed after each procedure. Reprocessing may include cleaning, reprocessing, disinfection, and / or sterilization after each procedure. In many cases, these procedures can be aggressive processes that kill bacteria and / or germs and, therefore, can be harsh on the endoscope.

[0059] The present invention recognizes the need for a disposable or single-use device that includes an endoscope (e.g., a disposable or single-use endoscope). There are several advantages to having a disposable device. A disposable device, such as a disposable endoscope, may not require post-operative cleaning, sterilization, and disinfection. The disposable or single-use device can be discarded by the user after surgery, saving the user valuable time and energy. In addition, since cleaning procedures may be harsh on endoscopes and may force complex endoscope designs to comply with such cleaning procedures, having a disposable endoscope can simplify endoscope design. Provided herein is a device that includes a disposable endoscope.

[0060] Moreover, instruments are often used or combined with an endoscope, which may require a user (e.g., a surgeon) to separately hold the endoscope and one or more instruments or tools. Alternatively, multiple people may need to separately hold such instruments and the endoscope. Completing such procedures may require more space. It is recognized herein that there is a need to provide an integrated device that includes an endoscope and one or more instruments that can be used in combination with the endoscope to save space and make the procedure easier and more convenient.

[0061] In some cases, the instruments and devices that can be used in combination with an endoscope can be single-use or disposable. Such instruments or tools (e.g., disposable instruments) can include mechanical tools, lasers, inflatable tips (e.g., balloons), crushers, implant / stent delivery devices, suturing devices, and other devices and instruments. These instruments are typically designed by separate entities other than the endoscope manufacturer. This may be partly due to the fact that in most cases, endoscopes can be complex and difficult to design and produce, and instrument manufacturers may choose to focus on designing instruments that work with specific types of endoscopes. Although disposable or single-use devices and instruments have become increasingly popular in recent years, there is still a need to design and produce disposable single-use endoscopes. Therefore, most (if not all) currently available endoscopes are still reusable. This article provides devices and uses thereof including disposable or single-use endoscope systems to address the shortcomings associated with reusable endoscopes. In some examples, a single-use endoscope may also include other instruments (e.g., one or more disposable instruments) integrated therein as a single device. In some cases, such instruments can be provided separately from a single-use endoscope. In many cases, it may be preferable to integrate such an instrument (e.g., one or more disposable instruments) with the endoscope into a single unit / device because it can provide advantages including the smaller size of the entire device, as well as convenience and other benefits compared to when the devices would be used separately.

[0062] In common endoscopic diagnostics (e.g., existing devices and methods), biopsies, and treatments, a separate instrument or several separate instruments are often used in combination with one or more endoscopes. This has been medical practice for the past few decades, at least in part because endoscopes and instruments may often be manufactured at different times by different device manufacturers. Even when they are manufactured and produced by the same entity, because the cost of endoscopes can be very expensive, in some cases, capital equipment, the instruments may be provided as devices separate from the endoscope. These instruments can come in many different formats: simple mechanical tools such as graspers, scissors, baskets, snares, curettes, and other devices. Advanced instruments such as laser fibers, suturing tools, balloons, morcellators, various implant or stent delivery devices, and the like. Such instruments can be combined with many different types of endoscopes (such as neuroendoscopes, encephaloscopes, ophthalmoscopes, otoscopes, rhinoscopes, laryngoscopes, gastroscopes, esophagoscopes, bronchoscopes, thoracoscopes, pleuroscopes, angioscopes, mediastinoscopes, nephroscopes, gastroscopes, duodenoscopes, common bile ductoscopes, bile ductoscopes, laparoscopes, choledochoscopes, ureteroscopes, hysteroscopes, cystoscopes, proctocopies, colonoscopes, arthroscopes, sialoscopes, etc.) for many different endoscopic examination procedures.

[0063] For example, morcellators are used in gynecology and rhinology to treat polyps. Balloons can be used to perform sinuplasty in rhinology. Implants or stents can be used to treat fluid behind the eardrum (tympanostomy), open sinus ostia, or treat benign prostatic hyperplasia (BPH) by opening the prostate gland ducts. Suturing devices can be used to suture the inside of the stomach. Laser fibers can be used for ablation or coagulation in urology, gynecology, and other fields.

[0064] Conventional endoscopes can be quite large in size (e.g., a few millimeters to a few centimeters in outer diameter). To accommodate any of the aforementioned instruments, a working channel may be required in the endoscope to allow passage of the instrument. In some cases, there may be more than one working channel to allow passage of multiple instruments simultaneously or at varying intervals. In most cases, this type of design can treat the instrument and endoscope as two separate devices and, therefore, can define a clear mechanical interface between the instrument and endoscope. While this can simplify the design of both the instrument and the endoscope, in some cases, it can result in the overall size of the endoscope being larger than necessary.

[0065] It is recognized herein that there is a need for low-cost and single-use miniaturized endoscopes. In some cases, the endoscopes provided herein may include integrated instruments such as visual instruments, cameras, sensors, lighting devices, etc. Such endoscopes can be used for treatment in various applications, such as diagnosis and / or treatment of diseases. The devices and methods may include applications for bronchoscopy, urology, gynecology, arthroscopy, otolaryngology, gastrointestinal endoscopy, etc. In some cases, the devices provided herein may be miniaturized combination endoscopes (e.g., combined with other devices such as camera modules, lighting, and modes) and may be single-use to avoid the challenges of cleaning and sterilization. The key requirements of minimizing size (i.e., outer diameter) and keeping low cost can be achieved through imaging system design, lighting methods and designs, and shaft designs including articulation. Some of these goals will be met by the devices described in this disclosure.

[0066] Disposable endoscopes are provided herein. In some examples, a disposable single-use endoscope with an integrated instrument (e.g., a disposable instrument) is provided. In some cases, the entire device is disposable or single-use. In some examples, a device is provided that includes an endoscope and one or more instruments integrated into a single device. The device may include a camera module. The camera module and / or imaging sensor may be low-cost and / or disposable (or single-use). The materials used may include specific qualities and characteristics that make them ideal for incorporation into a single-use / disposable endoscope.

[0067] Among other advantages, this integration can advantageously reduce, minimize or optimize the overall size of the combined device. In some cases, the combined / integrated device can be designed to be disposable or single use, which can greatly reduce the chance of infection and reduce post-processing (such as cleaning, sterilization, disinfection, etc.) requirements.

[0068] In some examples, the devices and systems provided herein can have applications including diagnosis and / or treatment of conditions (e.g., medical conditions) in subjects (e.g., humans or animals) such as conditions related to urology, gynecology, rhinology, otology, laryngoscopy, gastroenterology, and other fields. Applications may include addressing conditions in other parts of the subject, such as the eyes, stomach, intestines, ovaries, and the like.

[0069] In some cases, provided herein is method and system and can be combined in one or more ways to provide improved diagnosis and / or treatment to experimenter (for example, patient).For example, described method and system can be combined with existing method and equipment (such as, with the known method combination of the surgical operation of urology, gynecology, laryngology, ontology, gastroenterology diagnosis or other tissue and organ) to provide improved treatment or diagnosis.Similarly, provided herein is device and / or method and can be combined with identical or other instrument and / or tool to solve, diagnose or treat any human or non-human subject's health, disease, benign or malignant other conditions.It should be understood that any one or more of structure and / or program described herein can be combined with any one or more other structure and / or program of method and equipment described herein.

[0070] Provided herein are systems / devices and methods including endoscopes with integrated instruments / tools and capabilities for diagnosis and treatment of a subject. In some examples, the endoscope can be a disposable or single-use endoscope. Devices including disposable or single-use endoscopes can also include visual capabilities, such as a camera module integrated therein. In some cases, the camera module can be integrated at the distal tip of the endoscope. Alternatively, the camera module can be located elsewhere in the device.

[0071] The device may also include one or more instruments. In some examples, the one or more instruments may be one or more disposable or single-use instruments. Instruments that can be used in combination with an endoscope, either alone or as an integral part of a single system or device that includes an endoscope (e.g., a disposable endoscope), may include mechanical tools, power tools, optical tools, sensors, cameras or camera modules, chemicals, materials (e.g., degradable materials, biocompatible materials, hydrogels, etc.), drugs, lasers, inflatable tips (e.g., balloons), crushers, implant / stent delivery devices, suturing devices, etc., as well as combinations of any configuration and / or setting (e.g., built-in, integrated, or used alone).

[0072] In some examples, other tools and / or instruments can be used in combination with the devices provided herein, either individually or integrated within the same device or system. Such instruments can include neuroendoscopes, encephaloscopes, ophthalmoscopes, otoscopes, rhinoscopes, laryngoscopes, gastroscopes, esophagoscopes, bronchoscopes, thoracoscopes, pleuroscopy, angioscopes, mediastinoscopes, nephroscopes, gastroscopes, duodenoscopes, common bile duct mirrors, bile duct mirrors, laparoscopes, choledochoscopes, ureteroscopes, hysteroscopes, cystoscopes, proctocopies, colonoscopes, arthroscopes, sialoscopes, other tools and instruments, and / or any configuration and / or setting (e.g., built-in, integrated or used alone) of any combination thereof.

[0073] In some examples, the present disclosure provides a method comprising: providing an endoscope comprising a disposable elongated member comprising a proximal end and a distal end, and a camera module located at the distal end, wherein the proximal end is removably attached to a support member; providing one or more disposable instruments; and integrating the one or more disposable instruments into the endoscope to form an integrated single device. In some examples, the camera module may be located at a location other than the distal end. For example, the camera module may be located on a separate shaft within the device.

[0074] In some examples, the method may also include using an integrated single device to perform the functions of an endoscope and one or more disposable instruments.

[0075] In some examples, integrating one or more disposable instruments into an endoscope to form an integrated, single device may not require user assembly. In some embodiments, the integrated, single device may be provided in sterilized packaging. In some embodiments, the method may further include selecting at least one disposable instrument from the one or more disposable instruments to be integrated prior to performing the function. For example, an endoscope, a camera module, and one or more instruments (e.g., disposable instruments) may be provided to a user. The user may select a combination of endoscopes, camera modules, and / or instruments to use. The user may then assemble and use the device. Alternatively, in some examples, the endoscope, camera module, and one or more instruments (e.g., disposable instruments) may be assembled prior to providing the endoscope to the user. For example, the components may be permanently attached, connected, or otherwise integrated using any of the methods or mechanisms provided herein and readily available without requiring user assembly. Furthermore, the device may be disposable. Therefore, the user may not need to assemble the device or perform post-operative cleaning. This may provide a significant advantage to the user. Furthermore, since post-operative cleaning is not required, the endoscope may not need to be designed to be compatible with such often demanding post-operative cleaning procedures. Consequently, the design and / or production of the endoscope may be simplified.

[0076] In some examples, an adhesive material can be used to integrate one or more instruments (e.g., disposable instruments) into a device (e.g., to an endoscope). In some examples, the adhesive material can be biocompatible. In some examples, one or more instruments (e.g., disposable instruments) can be integrated into a device (e.g., to an endoscope) via one or more mechanical connection features. In some examples, the one or more mechanical connection features can include a quick release mechanism. In some examples, the one or more mechanical connection features can include a snap mechanism. In some examples, the device can be integrated and packaged (e.g., in a sterilized package) and can also be delivered to the user. Thus, the user may not need to assemble the device prior to surgery.

[0077] In some examples, the device can be disposable. Thus, the method can not require post-operative cleaning of the device. In some examples, integrating one or more instruments (e.g., disposable instruments) into a device (such as, into an endoscope) can include the use of one or more locks.

[0078] In some examples, integrating one or more instruments (e.g., disposable instruments) into a device and / or into a device (e.g., into an endoscope) can include using a mechanism or tool selected from the group consisting of: heating, welding, gluing, friction, snapping, locking, clamps, tracks, mechanical deformation, bonding with adhesive epoxy, glue, biocompatible glue, curing with light, brazing, soldering, mechanical fastening, interlocking connections, flanges, and / or other instruments, tools and / or mechanisms or any combination thereof.

[0079] Provided herein are devices and methods for treating conditions at a subject or subject's site. Conditions can include health or disease conditions, such as benign prostatic hyperplasia (BPH) or other human or animal diseases. Subjects can include animal subjects, such as mice, pigs, horses, monkeys, rats, mammals, rodents, and other animals. Subjects can include human subjects, such as patients. Different parts of a patient's body may be healthy or may suffer from different types of diseases. The subject's site can include sites such as the sinuses, ureters, colon, esophagus, blood vessels, throat, brain, heart, lungs, intestines, eyes, skin, liver, pancreas, stomach, uterus, ovaries, testicles, bladder, ears, nose, mouth, bone marrow, adipose tissue, muscle, glands, mucosal tissue, spine, neural tissue, cartilage, teeth, and bones.

[0080] In some examples, the present disclosure provides methods and systems (such as, disposable devices with integrated visual capabilities) for treating benign prostatic hyperplasia and other conditions. Benign prostatic hyperplasia (BPH) is a common disease in men, especially older men. Minimally invasive surgical treatments for BPH are often used in practice. They include, but are not limited to: transurethral resection of the prostate (TURP), transurethral incision of the prostate (TUIP), transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), laser ablation, photoselective vaporization of the prostate (PVP) and holmium laser ablation of the prostate (HoLAP), holmium laser enucleation of the prostate (HoLEP), prostate lift (i.e., Urolift), stents or implants (i.e., Zenflow implant), water vapor therapy (i.e., Rezum).

[0081] During these minimally invasive procedures, a cystoscope or resectoscope is often used to access the bladder, prostate, or urethra. These endoscopes typically consist of multiple components, including a sheath, tube, tool channels, and water channels. In many cases, some or all of these components may need to be assembled prior to the surgical procedure.

[0082] In some scenarios, a therapeutic tool or instrument can then be inserted into the working channel. For example, a laser fiber can be inserted into the working channel to perform PVP, HoLAP, or HoLEP. A monopolar or bipolar instrument with an electrical circuit can be inserted to perform TURP. In some examples, one or more needles can be inserted to perform TUNA. In other scenarios, the implant, stent, or (one or more) lift delivery instruments may be complex and have a dedicated working channel for insertion into the scope tube. These instruments may also have built-in water channels. For example, the Zenflow implant delivery device. Similarly, a steam delivery device may also include a channel for insertion into the scope tube (i.e., the Rezum device).

[0083] Typically, these instruments are designed to be low-cost and single-use for sterilization purposes. However, due to their precision-manufactured optics, endoscopes can be quite expensive and are often retained as reusable items and used as equipment. In some cases, a surgeon may need to assemble a reusable endoscope into a disposable instrument, or vice versa, before a surgical procedure. After most / all procedures, the endoscope may need to be removed from the instrument and then cleaned and sterilized.

[0084] Traditionally, endoscopes can generally include a working channel that can allow instruments to pass through and operate under endoscopic view. Alternatively, instruments can have a scope channel that allows insertion of a scope tube so that the instrument is operable under endoscopic view. For more commonly disposable instruments, this combination can result in a mixed scenario where the endoscope can still need to be cleaned and disinfected. What is identified here is a disposable package with a disposable instrument and a disposable endoscope. The systems, devices, and methods provided herein can improve clinical workflow and efficiency.

[0085] When both the instrument and the endoscope are single use, it can be desirable to integrate them into one combined device. It can be desirable to utilize low cost camera modules to integrate such cameras into single use devices to simplify the workflow of such devices. Integrating instruments with vision capabilities can optimize the overall size of the device and minimize patient pain.

[0086] Traditionally, endoscopes can generally include a working channel that can allow instruments to pass through and operate under endoscopic view. Alternatively, instruments can have a scope channel that allows insertion of a scope tube so that the instrument is operable under endoscopic view. For more commonly disposable instruments, this combination can result in a mixed scenario where the endoscope can still need to be cleaned and disinfected. What is identified here is a disposable package with a disposable instrument and a disposable endoscope. The systems, devices, and methods provided herein can improve clinical workflow and efficiency.

[0087] An integrated disposable (or single use) device with integrated instruments and vision capabilities can provide benefits such as disinfection, reduced cost, smaller overall size, improved patient comfort, better usability, simpler and leaner workflow, etc.

[0088] FIG. 1 An example device 100 according to some embodiments of the present disclosure is schematically illustrated. In other examples, the device can include other designs, configurations, and uses, such as other designs, configurations, and uses provided elsewhere herein. In some cases, FIG. 1 The device illustrated in FIG. 1 can be used for various applications, such as urological applications, i.e., BPH. The device can also be used for treating other parts of the body or other diseases, i.e., stone treatment. Examples include, but are not limited to: sinuses, ureters, colon, esophagus, blood vessels, throat, brain, heart, lungs, intestines, eyes, skin, liver, pancreas, stomach, uterus, ovaries, testicles, bladder, ear, nose, mouth, bone marrow, adipose tissue, muscle, glands, mucosal tissue, spinal column, neural tissue, cartilage, teeth, and bone. Examples of some variations of the device are provided in other figures.

[0089] Reference is made to FIG. 1The device 100 can be a disposable (single-use) integrated device. For example, the device can include a disposable endoscope with visual capabilities (such as a disposable endoscope including a camera module that can also be disposable). In some cases, the device can be used more than once or include some parts that may not be disposable. Providing a partially or fully disposable device (preferably fully disposable) can have the following advantages: the device may not require post-operative cleaning and sterilization, and can simplify endoscope design. In some cases, the device can include visual capabilities (such as a camera module). A camera sensor with a lens 101, such as a CMOS, CCD, or other type of sensor or camera module, can be positioned distally of the device. The camera module (e.g., camera sensor) can be a low-cost camera sensor with a lens. In some cases, the low-cost camera can be discarded after surgery. In some examples, an illumination source (e.g., an integrated light source, such as an LED) can be attached to the distal tip 102. In some examples, the camera module and illumination source can be attached to the distal tip of the device. In some cases, the camera module and / or illumination source can be permanently attached. Alternatively, the camera or light source or both can be removably attached to the device distal tip.In other examples, the illumination (or light) source can be permanently or removably attached to another position / area on the device.

[0090] refer to FIG. 1 In some examples, the camera module 101 may be tilted at a given angle within a device (e.g., an integrated device). For example, the given angle may be 0 degrees, 1 degree, 5 degrees, 10 degrees, 12 degrees, 18 degrees, 30 degrees, or another angle. This may form an endoscope with a side view. In some cases, the camera module may not be tilted within the device. In some examples, the camera module may be tilted at an angle of at least about 1 degree, 5 degrees, 10 degrees, 12 degrees, 15 degrees, 18 degrees, 20 degrees, 25 degrees, 30 degrees, 35 degrees, 40 degrees, etc. In some examples, the camera module may be tilted at an angle of at most about 60 degrees, 55 degrees, 50 degrees, 45 degrees, 40 degrees, 35 degrees, 30 degrees, 25 degrees, 20 degrees, 18 degrees, 12 degrees, 10 degrees, 5 degrees, 1 degree, or less.

[0091] refer to FIG. 1 In some cases, the device can include one or more shafts. In some cases, the shaft can include a multi-lumen shaft. FIG. 1 A channel may be provided inside the device shaft 103 (e.g., a multi-lumen shaft) to allow the semi-rigid needle tube 104 to bend sideways and away from the shaft. The implant may be advanced through the needle tube into the patient's body using various methods, such as, for example, a mechanism within the proximal handheld device (or handpiece), such as FIG. 6A and FIG. 6BAs shown. As an example, the needle tube 104 may include or be an implant delivery channel, such as FIG. 4A The channel shown in .

[0092] refer to FIG. 1 Another purpose of the channel 104 may be to allow steam to flow from the proximal end of the curved needle to the distal tip ( FIG. 4B The steam may comprise any pressure and / or any temperature. In some cases, the steam may comprise high pressure and high temperature. In some cases, the same channel may be used to transfer other media or instruments, i.e., drugs, (onabotulinumtoxinA), green laser fiber, holmium laser fiber, or other media, instruments, and / or materials are delivered to a subject or a site on the subject. Alternatively, other channels in the device can be used to deliver such media, materials, and / or instruments to the desired site on the subject. For example, in some cases, the device can include multiple channels for delivering multiple materials or instruments. The channels can be similar or different from each other.

[0093] refer to FIG. 1 In some cases, the channel can allow fluid to enter or leave the patient's body. FIG. 1 Another view of the device 110 is shown in FIG. FIG. 1 Also shown is a cross-sectional view of the device 110 including a cross-sectional view of a camera module 107 and a cross-sectional view of one or more illumination sources 106. The proximal end of the device is shown as a block at 105. FIG. 3 Details of the proximal end of the example devices provided herein can be found in. In other examples, the devices can include other designs, configurations, and uses, such as those provided elsewhere herein.

[0094] FIG. 2A and FIG. 2B Example apparatus according to the apparatus and methods provided herein are shown. FIG. 2A and FIG. 2B The distal portion of an example device is shown in FIG. The device can be a disposable (single-use) device with visual capabilities. For example, the device can include an endoscope including a camera module. The endoscope can be disposable. The camera module can be disposable. The device can be partially or fully disposable. FIG. 2A and FIG. 2B The device shown in can be FIG. 1 An alternative design of the device shown in . Similar to FIG. 1 In the arrangement, both the camera module and the illumination source can be attached to the distal tip. FIG. 2A and FIG. 2BThe device shown in FIG2 may also include one or more disposable instruments. For example, the one or more disposable instruments may include or be an implant / stent delivery device, apparatus, or instrument. The device may also include a channel 201. In some examples, the channel may be an implant / stent delivery channel 201, which may be positioned on the device (e.g., near the camera module). The channel (e.g., a delivery channel) may be axially movable relative to the axis of the device. FIG. 2B A cross-sectional view of the front face 202 is shown in FIG.

[0095] In some examples, the device provided herein may include a camera module. In some examples, the device may include one or more cameras or imaging modules or systems. In some examples, the camera module may include a fluoroscopic (tomosynthesis) imaging system for providing real-time imaging of a target site (e.g., including a certain disease). In some cases, the camera module or imaging system may track the position of a given object inside the body or for verification purposes before or during a surgical operation. In some cases, any suitable motion / position sensor (e.g., an inertial measurement unit (IMU)), one or more gyroscopes, velocity sensors, accelerometers, magnetometers, position sensors (e.g., global positioning system (GPS) sensors), visual sensors (e.g., imaging devices capable of detecting visible light, infrared light, or ultraviolet light, such as cameras), proximity or distance sensors (e.g., ultrasonic sensors, lidars, time of flight, or depth cameras), altitude sensors, attitude sensors (e.g., compasses), and / or field sensors (e.g., magnetometers, electromagnetic sensors, radio sensors) may be used. One or more sensors for tracking the motion and position of a fluoroscopic (tomosynthesis) imaging station may be provided on the imaging station or located away from the imaging station, such as wall-mounted cameras. As described anywhere herein, various gestures may be captured by one or more sensors.

[0096] FIG. 5A and FIG. 5B Two examples of devices provided herein are shown in In some examples, the devices can include a camera module that can be proximate to a device channel, such as an implant delivery channel.

[0097] In some examples, a channel (such as FIG. 2A The channel 201 shown in FIG. 20 may accommodate mechanical, electrical, optical, or other energy devices such as graspers, scissors, snares, barrels, needles, monopolar, bipolar cautery instruments, radiofrequency ablation instruments, green laser fibers, holmium laser fibers, and / or other devices.

[0098] refer to FIG. 2A In some cases, channel 201 can accommodate a needle for biopsy, steam delivery, cryotherapy delivery, drug delivery, botulinum toxin, and / or other procedures.

[0099] In some examples, FIG. 1 、 FIG. 2A and FIG. 2B The device shown in can include and / or use rigid, semi-rigid, flexible or articulated device shaft.In such cases, the implant delivery channel can also be rigid, semi-rigid, flexible or articulated.In some examples, the distal end of the device can be articulated with two or more degrees of freedom.

[0100] The device or endoscope can include a proximal end. The proximal end can be attached (e.g., removably attached) to a support member. In some examples, the support member can include or be a handheld device.

[0101] In some examples, the support member can include a mechanical interface configured to control articulation of the distal end of the endoscope or operation of one or more instruments (e.g., disposable instruments). In some examples, the mechanical interface can include a drive mechanism for one or more pull wires attached to the distal end. In some examples, the mechanical interface can include a mechanism for manipulating one or more disposable instruments.

[0102] FIG. 3 An example of a proximal end of a device connected to a support member is shown in FIG. In this example, the support member is a handheld device (also referred to as a handpiece). Alternatively, in other examples, the support member may include or be a robotic arm, or be configured to be attached to or connected to a robotic arm. FIG. 6A and FIG. 6B Two examples of handheld devices (or handpieces) are shown in FIG.

[0103] A support member, such as a handheld device or a robotic arm, can be configured to control or manipulate the functions of the device, including the functions of the endoscope, the camera module, and / or one or more disposable instruments. For example, one or more instruments (e.g., one or more disposable instruments) may include or be an implant / stent delivery device. The device may also include a channel. A support member, such as a handheld device (or handpiece) or a robotic arm, may also include an interface for controlling, executing, and / or manipulating the functions of the endoscope and / or one or more disposable instruments. In some examples, the interface may include or be a mechanical interface. In some examples, the interface may include or be an electrical interface. In some examples, the interface may include or be a button. The button may include a mechanical and / or electrical button. The channel can be used to deliver the implant to the intended location of the subject. In this example, the handheld device (or handpiece) can be configured to control the functions of the endoscope and the implant delivery device.

[0104] refer to FIG. 3Within the handheld device (or handpiece), as an example, a channel (e.g., a working channel or an implant delivery channel) can have one or more hard stops 301. The channel can be an implant delivery channel, such as a channel that can be used to deliver an implant or stent into a subject’s intended site. In other examples, the channel can include other applications. The hard stops can be along an axial direction. This can provide a safety stop to avoid the channel being inserted too far into the subject’s body. In some examples, a mechanical and / or electrical interface (e.g., a button 302) can be positioned on a proximal side. The mechanical and / or electrical button can enable delivery of an implant / stent, and / or can be used for other purposes and / or applications. Other applications of the interface or button can include insertion of the channel (e.g., a delivery channel). In some cases, the device can include more buttons. The same or other buttons can allow for image capture, video recording, white balancing, and / or other functions.

[0105] Referring to FIG. 3 In some cases, one or more mechanisms can connect the mechanical and / or electrical button 302 to the implant delivery channel or implant cartridge. Examples can include a hinge 305 that can connect the button 302 to the channel 300. In some cases, different mechanisms can be used and / or implemented. In some examples, such mechanisms can be complex (e.g., more complex than a hinge). The mechanisms can include or be mechanical and / or electrical mechanisms or a combination thereof. For example, the electrical interface can include a control system that can send signals (e.g., electrical or digital signals) to different parts of the device and thereby control the functions of the device, such as the endoscope, the support member, the one or more disposable instruments, etc.

[0106] Referring to FIG. 3 In some cases, the device or system can include one or more interfaces 303 for fluid management. Such interface(s) can be present at the proximal end of the device or elsewhere in the device and / or region. In some cases, the interface can be a lure connector to enable fluid, vapor, or other media to flow in or out. In some cases, the interface can be used to allow an implant delivery instrument or other instrument (e.g., an instrument mentioned elsewhere herein, such as the one or more disposable instruments) to pass through. Another use of the interface can be to allow a separate endoscope (such as a single-use or disposable endoscope) to be inserted and snapped to the rest of the device. In some cases, this can be used when the distal tip of the device does not have an integrated camera module.

[0107] There may be a mechanical and / or electrical interface 304 to allow the device to be connected to an image processing and / or display system, such as a laptop PC with a display monitor, a computing device, an iPhone, an iPad, a tablet, or any other type of computing device, machine, or display system. Alternative options may include an imaging processing unit and a display monitor.

[0108] In some examples, the support member may be or be connected to a robotic arm. FIG. 18 An example of a robotic arm 1810 that can be used is shown. In some examples, such as FIG. 18 As shown in , the robotic arm can be mounted on top of the robotic cart. The robotic arm 1810 can automatically position the intended part of the device to an initial orientation (e.g., an access point) to reach the target part of the subject (e.g., tissue). In some cases, the robotic arm can be moved passively by the operator. In such cases, the operator can push the arm to any orientation and the arm moves compliantly. In some cases, the robotic arm can be controlled in a compliant mode to improve human-robot interaction. For example, the compliant motion control of the robotic arm can adopt a collision avoidance strategy, and the directional force control can be designed to save unnecessary energy consumption while reducing the impact of possible collisions. In some embodiments, the instrument drive mechanism can be mounted to the robotic arm. The arm can have redundant degrees of freedom, allowing its elbow to be moved algorithmically or passively into a configuration that may be convenient for the operator.

[0109] Provided herein is a device comprising an endoscope that may include an elongated member. The elongated member may include a proximal end and a distal end. The endoscope may be disposable. The device may also include a camera module. In some examples, the camera module may be positioned at the distal end of the endoscope. In other examples, the camera module may be positioned at other areas on the device. In some examples, the device may include one or more camera modules at different locations on the device. Reference FIG. 7 For example, the device can include an outer shaft. The outer shaft can include a camera module (e.g., embedded therein). The outer shaft can also include an illumination source. In some examples, an implant / stent delivery shaft or a vapor delivery shaft can be positioned within another channel of the outer shaft. FIG. 7 An example of such a design is shown. The shaft(s) may be articulated. One or more pull wires may articulate the shaft.

[0110] In some cases, for reasons of design simplicity or adaptability, the camera module with illumination (e.g., a disposable, single-use camera module) can be on a separate shaft that can be inserted into a channel within the device shaft. Once inserted, the camera module shaft can be snapped onto the device shaft, making it an integrated device. In this example, in some cases, the camera module shaft can be removed from the integrated device.

[0111] The device may also include one or more instruments (e.g., disposable instruments) integrated thereon. In some cases, a disposable endoscope, a camera module, and one or more instruments (e.g., disposable instruments) may be integrated into a single device. The integrated single device may be disposable. In some examples, the camera module may be at the distal tip of the endoscope. In other examples, the camera module may be located in other areas of the device and may not be at the distal tip of the endoscope. For example, FIG. 7 In the device shown in FIG, the camera module can be embedded on a separate axis in the integrated device.

[0112] In one aspect, the present disclosure provides a device comprising: (a) an endoscope comprising: i) a disposable elongated member comprising a proximal end and a distal end; and ii) a camera module, which may be located at the distal end. The proximal end may be removably attached to a support member. The device may also include one or more instruments integrated into the endoscope. The instruments may be disposable or single-use. The device may be configured to perform the functions of both an endoscope and one or more disposable instruments.

[0113] FIG. 8 An example device 800 of a device according to the present disclosure is shown. The device includes an endoscope 801. The device may also include one or more instruments 802 (one instrument is shown as an example). The one or more instruments may be one or more disposable instruments. The device includes a distal end 803 and a proximal end 804. The distal end of the device 803 may include endoscope functionality and instrument functionality. The endoscope may include an endoscope distal end 805 and an endoscope proximal end. The instrument may include an instrument distal end 806 and an instrument proximal end.

[0114] The endoscope 801 may include an elongated member. The elongated member of the endoscope may also be referred to as a shaft 103 or a catheter. FIG. 1 An example of an endoscope including a shaft is shown in FIG.

[0115] In some examples, the outer diameter of the distal tip of the endoscope (such as the diameter of the elongated member, shaft, or catheter) can be approximately 4 to 4.4 millimeters (mm). In some examples, the endoscope can include a channel. The diameter of the channel can be approximately 2 mm.

[0116] In some examples, the endoscope may include a camera module. The camera module may be at the distal end of the endoscope. FIG. 8 The camera module is not shown. FIG. 1 An example endoscope including a camera module 107 is shown in FIG. FIG. 9 Other examples of devices including camera modules are shown in and other figures.

[0117] In some examples, at least one of the one or more disposable instruments can be integrated into the endoscope via a permanent connection to a distal end, such as the distal end of endoscope 805 or the distal end of device 803 .

[0118] In some examples, one or more pull wires may be integrated into the wall of the elongated member. The pull wires may facilitate articulation of the device or related parts of the device.

[0119] Mechanical packaging for endoscopes and instruments can take many forms. The proximal end of the device 804 can include or be connected to a support member. The support member can include or be a handheld device (or handpiece). Examples of handheld devices include FIG. 3 and described in further detail in the following paragraphs.

[0120] In some examples, the support member can be a handheld device. The handheld device can include or be referred to as a handpiece. The handpiece can include the functionality of an instrument and an endoscope, which can be combined into one (or the same) handpiece as an integrated device or system, such as FIG. 8 Or any other example arrangement shown in the figures.

[0121] In some examples, the device may further include an interface between the distal portion and the support member. In some examples, the support member may include or be a robotic arm. Alternatively, the support member may be coupled to a robotic arm. In some embodiments, the support member may be reusable. In some embodiments, the support member may be configured to control functions of the endoscope and one or more instruments.

[0122] FIG. 18 An example of a robotic arm is shown in and described in further detail in the following paragraphs. The support member can be reusable. The device including the endoscope and one or more instruments can be disposable.

[0123] In some cases, the instrument and endoscope may be used in combination but not integrated into the same device. For some purposes, it may be desirable to integrate the instrument and endoscope.

[0124] Optionally, there can be an interface between the distal portion of the device (the endoscope and instrument combination) and the support member (e.g., a handheld device, handpiece, or robotic arm). The interface is optional, and if present, the distal portion of the device can be disposable and single-use, and the support member (e.g., handpiece) can be designed to be reusable.

[0125] The present invention provides embodiments including but not limited to the following:

[0126] 1. A device comprising:

[0127] (a) An endoscope comprising: i) a disposable elongated member including a proximal end and a distal end; and ii) a camera module located at the distal end, wherein the proximal end is removably attached to a support member; and

[0128] (b) one or more disposable instruments, said one or more disposable instruments being integrated into said endoscope,

[0129] wherein the device is configured to perform the functions of both the endoscope and the one or more disposable instruments.

[0130] 2. The device of embodiment 1, wherein the distal end is articulated with two or more degrees of freedom.

[0131] 3. The device of embodiment 1, wherein at least one of the one or more disposable instruments is integrated into the endoscope via a permanent connection at the distal end.

[0132] 4. The device of embodiment 1, wherein one or more pull wires are integrated into the wall of the elongated member.

[0133] 5. The device of embodiment 1, wherein the one or more disposable instruments are one or more instruments selected from the group consisting of a morcellator, scissors, a needle, an illumination source, a laser, a balloon, an implant / stent delivery device, a suturing device, a laser fiber, a grasper, a snare, a ring, and a barrel.

[0134] 6. The device of embodiment 1, wherein there is substantially no relative movement between the camera module and the one or more disposable instruments.

[0135] 7. The device of embodiment 1, wherein the camera module and the one or more disposable instruments are permanently integrated into the endoscope, and wherein there is substantially no relative movement between the camera module and the one or more disposable instruments.

[0136] 8. The apparatus of embodiment 1, wherein the camera module is configured to provide a static view of the one or more disposable instruments.

[0137] 9. The device of embodiment 1, wherein the camera module is fixed relative to the one or more disposable instruments.

[0138] 10. The device of embodiment 1, wherein the distal end includes an endoscopic function and an instrument function.

[0139] 11. The device of embodiment 1, wherein the support member comprises a mechanical interface configured to control articulation of the distal end of the endoscope or operation of the one or more disposable instruments.

[0140] 12. The device of embodiment 11, wherein the mechanical interface comprises a drive mechanism for one or more pull wires attached to the distal end.

[0141] 13. The device of embodiment 11, wherein the mechanical interface comprises a mechanism for manipulating the one or more disposable instruments.

[0142] 14. The device of embodiment 10 further comprises an interface between the distal portion and the support member.

[0143] 15. The apparatus of embodiment 1, wherein the support member is a robotic arm, or the support member is coupled to a robotic arm.

[0144] 16. The device of embodiment 1, wherein the support member is reusable.

[0145] 17. The device of embodiment 1, wherein the support member is configured to control functions of the endoscope and the one or more disposable instruments.

[0146] 18. The device of embodiment 1, wherein the support member is a handheld device.

[0147] 19. The device of embodiment 1, wherein the endoscope is disposable.

[0148] 20. The device of embodiment 1, wherein the one or more disposable instruments comprises a morcellator.

[0149] 21. The device of embodiment 1, wherein the morcellator is located at the distal end.

[0150] 22. The apparatus of embodiment 21, wherein the camera module is proximate to the pulverizer.

[0151] 23. The device of embodiment 1, wherein the one or more disposable instruments comprise an illumination source.

[0152] 24. The apparatus of embodiment 23, wherein the illumination source is positioned proximate to the camera.

[0153] 25. The device of embodiment 23, wherein the illumination source comprises an illumination fiber or one or more light emitting diodes (LEDs).

[0154] 26. The device of embodiment 1, wherein the endoscope comprises a channel.

[0155] 27. The device of embodiment 21, wherein the pulverizer comprises an outer tube and an inner tube.

[0156] 28. The apparatus of embodiment 21, wherein the relative motion between the shredder and the camera module is substantially zero.

[0157] 29. The apparatus of embodiment 21, wherein the apparatus is configured to provide a static view of the pulverizer.

[0158] 30. The device of embodiment 21, wherein the pulverizer is pre-curved.

[0159] 31. The device of embodiment 21, wherein the camera module is positioned in a neck region of the pulverizer.

[0160] 32. The device of embodiment 21, wherein the pulverizer comprises a shaft.

[0161] 33. The device of embodiment 21, wherein the camera module and the pulverizer comprise shafts.

[0162] 34. The device of embodiment 33, wherein the shaft is articulated with two or more degrees of freedom.

[0163] 35. The device of embodiment 33, wherein the shaft comprises one or more pull wires.

[0164] 36. The device of embodiment 1, wherein the one or more disposable instruments comprises an illumination source and a morcellator.

[0165] 37. The apparatus of embodiment 36, wherein the illumination source is positioned adjacent to the camera module.

[0166] 38. The device of embodiment 1, wherein the one or more disposable instruments comprises an inflatable tip.

[0167] 39. The device of embodiment 38, wherein the inflatable tip comprises an inflatable balloon.

[0168] 40. The device of embodiment 1, wherein at least one of the instruments comprises a shaft, and a distal portion of the shaft is connected to the distal end.

[0169] 41. The device of embodiment 38, wherein the inflatable tip comprises at least one of a structural tube and an internal reinforcement.

[0170] 42. The device of embodiment 38, wherein the device is configured to provide a static view of the inflatable tip.

[0171] 43. The device of embodiment 38, wherein the inflatable tip and the camera module are static relative to each other.

[0172] 44. The device of embodiment 1, wherein the one or more disposable instruments comprises an implant / stent delivery device.

[0173] 45. The device of embodiment 44, wherein the implant / stent delivery device is configured to perform sinus surgery.

[0174] 46. ​​The device of embodiment 44 further comprises an illumination source.

[0175] 47. The device of embodiment 44 further comprises a channel.

[0176] 48. The device of embodiment 44 further comprises an implant / stent delivery push mechanism.

[0177] 49. The device of embodiment 44, wherein the implant delivery device is configured to deliver a prostate implant.

[0178] 50. A method comprising:

[0179] An endoscope is provided, the endoscope comprising: a disposable elongated member including a proximal end and a distal end; and a camera module located at the distal end, wherein the proximal end is removably attached to a support member;

[0180] providing one or more disposable instruments; and

[0181] The one or more disposable instruments are integrated into the endoscope to form an integrated single device.

[0182] 51. The method of embodiment 50 further comprises using the integrated single device to perform the functions of the endoscope and the one or more disposable instruments.

[0183] 52. The method of embodiment 50, wherein integrating the one or more disposable instruments into the endoscope to form the integrated single device does not require user assembly.

[0184] 53. The method of embodiment 50, wherein the integrated single device is provided in sterilized packaging.

[0185] 54. The method according to embodiment 51 further includes selecting at least one disposable instrument from the one or more disposable instruments to be integrated before performing the function.

[0186] 55. The method of embodiment 50, wherein the one or more disposable instruments are integrated into the endoscope using an adhesive material.

[0187] 56. The method of embodiment 55, wherein the adhesive material is biocompatible.

[0188] 57. The method of embodiment 50, wherein the one or more disposable instruments are integrated into the endoscope via one or more mechanical connection features.

[0189] 58. The method of embodiment 57, wherein the one or more mechanical connection features comprise a quick release mechanism.

[0190] 59. The method of embodiment 57, wherein the one or more mechanical connection features comprise a snap-fit ​​mechanism.

[0191] 60. The method of embodiment 51, wherein the method does not require post-operative cleaning of the device.

[0192] 61. The method of embodiment 50, wherein integrating the one or more disposable instruments into the endoscope comprises using one or more locks.

[0193] 62. A method according to embodiment 50, wherein integrating the one or more disposable instruments into the endoscope includes using a mechanism or tool selected from the group consisting of: heating, welding, gluing, friction, snapping, locking, clamps, tracks, mechanical deformation, bonding with adhesive epoxy, glue, biocompatible glue, curing with light, brazing, soldering, mechanical fastening, interlocking connection and flange.

[0194] 63. An apparatus comprising:

[0195] (c) An endoscope comprising: i) a disposable elongated member comprising a proximal end and a distal end, and wherein the proximal end is removably attached to a support member; and

[0196] (d) a camera module; and

[0197] (e) one or more disposable instruments, said one or more disposable instruments being integrated into said device,

[0198] wherein the device is configured to perform the functions of both the endoscope and the one or more disposable instruments.

[0199] Integrated device with endoscope and morcellator

[0200] In some examples, the one or more instruments (e.g., disposable instruments) can be one or more instruments selected from the group consisting of a morcellator, scissors, a needle, a lighting source, a laser, a balloon, an implant / stent delivery device, a suturing device, a laser fiber, a grasper, a snare, a ring, a barrel, and / or any combination thereof. In some examples, the one or more disposable instruments can also include other instruments.

[0201] In some examples, one or more instruments (one or more disposable instruments) can include an illumination source and a morcellator. In some examples, the illumination source can be positioned adjacent to or near the camera module. In some examples, the illumination source can be positioned near the camera module.

[0202] In some examples, the endoscope may include a channel. In some examples, the diameter of the channel may be approximately 2 mm. In some examples, the diameter of the channel may be between 1 mm and 3 mm. In some examples, the pulverizer may include an outer tube and an inner tube. In some examples, the relative motion between the pulverizer and the camera module may be substantially zero. In some examples, the device may be configured to provide a static view of the pulverizer. In some examples, the pulverizer is pre-curved. In some examples, the camera module may be positioned in a neck region of the pulverizer. In some examples, the camera module may be positioned in other regions. In some examples, the pulverizer may include a shaft. In some examples, the camera module and the pulverizer may each include a shaft. In some examples, one or more shafts may be articulated with two or more degrees of freedom. In some examples, the shaft may include one or more pull wires.

[0203] refer to FIG. 9In some examples, a device (e.g., device 901) can include an endoscope 920 (e.g., a disposable endoscope), a camera module (e.g., a low-cost, disposable camera module at the distal tip or other location of the endoscope), and one or more instruments (e.g., disposable instruments). The one or more instruments can include a morcellator.

[0204] refer to FIG. 9 , a camera 908 (such as a disposable camera) can be mounted at the distal end near the morcellator 922 to form a combined device. This example can be referred to as a side-by-side configuration 901. The combined device can be a single unit that can be completely disposable. Alternatively, it may not be completely disposable and may include some reusable pieces. The device can be partially or completely disposable.

[0205] In some examples, one or more instruments (eg, one or more disposable instruments) may include an illumination source.

[0206] refer to FIG. 9 , one or more illumination sources or devices 909 can be positioned on an apparatus (e.g., apparatus 901 or other example apparatus), for example, near camera 908. The illumination source or device can include or be an illumination fiber, LED, or other illumination component, material, or device. The illumination source can be low-cost and disposable.

[0207] In some examples, the distal end of the endoscope and / or instrument can be articulated with two or more degrees of freedom. Different variations and configurations of such devices are shown herein, such as FIG. 9 to FIG. 13 and FIG. 14A to FIG. 14E middle.

[0208] In some examples, the endoscope may optionally include a channel. In some examples, the diameter of the channel may be approximately 2 mm. In some examples, the diameter of the channel may be between 1 mm and 3 mm. In some examples, the pulverizer may include an outer tube and an inner tube. In some examples, the relative motion between the pulverizer and a camera module (such as a camera module of an endoscope) may be substantially zero. In some examples, the device may be configured to provide a static view of the pulverizer. In some examples, the pulverizer is pre-curved. In some examples, the camera module may be positioned in the neck region of the pulverizer. In some examples, the camera module may be positioned in other regions. In some examples, the pulverizer may include an axis. In some examples, the camera module and the pulverizer may each include an axis. In some examples, one or more axes may be articulated with two or more degrees of freedom. In some examples, the axis may include one or more pull wires.

[0209] refer to FIG. 9, the device 901 (such as an endoscope of the device) can also include a channel 910. In some cases, the channel can be referred to as a working channel. In some examples, the channel can be an implant delivery channel. The channel can include other purposes and / or applications. The channel can be located at the distal end or elsewhere on the device. In some cases, the device can include a morcellator, and the channel can be shared with the morcellator. The morcellator can have an outer tube that can include indentations 911 and / or an inner tube that can include cutouts 912.

[0210] In some examples, there can be substantially no relative movement between the camera module and one or more instruments (e.g., disposable instruments), such that the camera can be configured to provide a static view of one or more instruments and / or tools. In some examples, the camera module and one or more instruments (e.g., disposable instruments) can be permanently integrated into the endoscope, and there can be substantially no relative movement between the camera module and the disposable instruments.

[0211] In some examples, the camera module can be configured to provide a static view of one or more disposable instruments. In some examples, the camera module can be fixed relative to the one or more disposable instruments.

[0212] In some cases, there may be minimal or substantially no relative motion between the distal end of the morcellator and the camera. The combined device can provide a static or substantially static view of the morcellator in the camera field of view. For example, the instrument (e.g., morcellator) may not move relative to the camera module and thus appear static in the image generated by the camera, which can be helpful during a procedure (e.g., observation or surgery).

[0213] The position of the morcellator can be stable in the camera's real-time view. Keeping the position of the morcellator stable in the camera's real-time view can be advantageous for many reasons. For example, when the operator attempts to move the combined device in the subject's body. The combined device can simplify ergonomics during surgery. In some cases, instead of holding the endoscope and one or more additional instruments separately, the operator may only need to hold a single device that includes the endoscope (e.g., a single-use endoscope), which may have one or more instruments (e.g., other instruments) integrated therein. Such instruments may include or be one or more cameras, lighting devices, other instruments, and / or combinations thereof. Improved ergonomics can result from such integration, which can greatly benefit and enhance surgical workflow efficiency and surgical safety.

[0214] FIG. 9Various examples of integrated devices that are substantially configured side by side are shown. For example, example device 903 shows a variation of the side-by-side configuration. Device 903 may include a pre-curved morcellator 924 and an endoscope 926. As shown in example device 903, the morcellator may have a pre-curved portion 928 around the distal end or near the tip, and the distal portion of the endoscope may be positioned adjacent to the pre-curved portion 928 at the neck region of the morcellator. In some cases, an endoscope (e.g., endoscope 926) does not have a pre-curved portion and the tip of the morcellator (e.g., morcellator 924) may be captured in the camera view of a camera module 930 located at the distal portion of the endoscope. The pre-curved morcellator may advantageously allow for a better view of its tip in the camera's real-time field of view.

[0215] In another example, such as in device 905, both endoscope 932 and morcellator 934 can have pre-curved portions. Example device 904 shows a variation of a side-by-side configuration. Device 904 can include a pre-curved endoscope and a pre-curved morcellator. In this example, the pre-curved configuration can allow for better access to the patient's body in areas that may be difficult to reach using a traditional rigid design such as that shown in example device 901. The difference between example device 903 and example device 904 is that in device 903, endoscope 926 is not pre-curved and only morcellator 924 is pre-curved, whereas in device 904, both morcellator 934 and endoscope 932 include pre-curved configurations.

[0216] Another variation of a side-by-side configuration is shown as example device 905. In example device 905, endoscope 936 may include an articulating and / or flexible shaft. For example, the elongated member of the endoscope may be an articulating or flexible shaft. In example device 905, an instrument (e.g., morcellator 938) may also include an articulating and / or flexible shaft. Endoscope 936 and the instrument (e.g., morcellator 938) may each include a shaft that can articulate with two or more degrees of freedom. In some cases, camera 940 may be positioned at the distal end (e.g., the distal end of endoscope 936). Alternatively, the camera may not be positioned at the distal end. Instead, the camera module may be positioned at another device location, such as other areas described elsewhere herein. In such cases, mechanical and / or electrical cables or lighting fibers may be located along the shaft. The shaft may be flexible and articulated. The morcellator (e.g., morcellator 938 or other instruments described in other devices herein) may be made of a torque coil that may be flexible (e.g., it may be made of a flexible material). Such a flexible design / configuration of a device (eg, device 905 ) may allow for improved or significantly improved accessibility to a patient's body part compared to existing devices (such as rigid devices).

[0217] refer to FIG. 9, another example of an apparatus is shown as apparatus 902. The position / orientation of camera 908 can be fixed relative to the pulverizers (e.g., 911 and 912). Alternatively, the camera position and / or orientation can be adjustable. As described anywhere herein, a fixed camera position can have several advantages. In some examples, the apparatus and systems provided herein can include an illumination source (or illumination component) 909, which can be integrated into the apparatus (any example apparatus, such as apparatus 901 or 902), such as in certain apparatus components. In some examples, the illumination source can be close to or incorporated near a camera or camera / imaging module 908 (such as in apparatus 901 or 902).

[0218] The example device 902 may include an "out-of-scope" configuration. In some cases, there may be minimal or substantially no relative motion between the camera module and the distal end of the morcellator. Thus, the camera module may be configured to provide a static view of the morcellator. For example, the instrument (e.g., morcellator) in the image may not move in the image provided by the camera module.

[0219] Similar to the side-by-side configuration, the mirrored circular configuration 902 can take the form of a pre-bent. An example of this is shown in device 906.

[0220] Alternatively, example devices, such as device 907, may include a flexible, articulating shaft. Both designs can improve control of the device tip and accessibility to the patient's body part.

[0221] In some examples, the designs described herein may be altered, or various combinations of designs may be used to facilitate a desired application.

[0222] Integrated device with endoscope and inflatable tip

[0223] In some examples, one or more disposable instruments can include an inflatable tip. In some examples, the inflatable tip can include an inflatable balloon. In some examples, the inflatable tip can be a structural component of the balloon. In some examples, at least one of the one or more disposable instruments can include a shaft, and the distal portion of the shaft can be connected to the distal end. In some examples, the inflatable tip can include at least one of a structural tube and an internal reinforcement. In some examples, the device can be configured to provide a static view of the inflatable tip. In some examples, there is substantially no relative movement between the inflatable tip and the camera module.

[0224] In some examples, one or more instruments (eg, one or more disposable instruments) may include an inflatable tip, such as a balloon (eg, an expandable balloon). FIG. 10 Some examples of such devices are shown in .

[0225] refer to FIG. 10 In some examples, such as device 1001 or other devices provided herein, a camera module (e.g., a low-cost and / or disposable camera) 1010 can be positioned adjacent to an inflatable tip (e.g., a balloon) 1013 at the distal end (or other location) of a device or endoscope (e.g., endoscope 1030) to form a side-by-side inflatable tip (e.g., balloon) with visual capabilities. In some cases, a device (e.g., device 1001) can also include an illumination source (or illumination feature) (e.g., illumination source 1011), which can optionally be positioned adjacent to a camera (e.g., camera 1010) or at other locations and / or orientations on the device.

[0226] Optionally, the device may further include a channel 1012. For example, endoscope 1030 may include channel 1012. In some cases, channel 1012 may be referred to as a working channel. The inflatable tip 1013 (e.g., a balloon) may be inflatable and / or may include a structural tube 1014 and / or an internal reinforcement 1015. In some examples, there may be minimal or substantially no relative motion between the distal end of the inflatable tip 1013 and the camera 1010 (e.g., when the device is in use). The combined device (e.g., device 1001) may provide a fixed view of the balloon 1013 in the camera's field of view. The position of the balloon may be stable in the camera's real-time view. This may provide advantages when the operator attempts to move the combined device within the patient's body. In some cases, the combined device (e.g., device 1001 or other example devices provided herein) may simplify ergonomics during surgery. In some applications, the operator may only need to hold a single device, rather than a separate endoscope and one or more separate instruments. Improved ergonomics can improve the efficiency of surgical workflow and the safety of surgery.

[0227] refer to FIG. 10 , a side-by-side configuration of the device (e.g., a combined device including an endoscope and one or more instruments (such as an inflatable tip)) can include a pre-curved portion. An example can be device 1004. The pre-curved portion can be incorporated into the neck region or other region of device 1004. Example device 1004 includes endoscope 1032 and an instrument, which can be inflatable tip 1034. In this example, both endoscope 1032 and inflatable tip 1034 can include a pre-curved portion.

[0228] Alternatively or additionally, the device can be flexible (or fully flexible) and / or have distal articulation. In this case, a drive cable or pull wire can be placed in an appropriate position to drive the tip of the combined device. The axis along the device can be primarily composed of electrical and / or mechanical wires and optional lighting fibers. In some cases, the inflatable tip (or balloon structure tube) 1014 can be soft and / or compliant.

[0229] As another example, FIG. 10 1002). A camera 1010 may be incorporated, integrated, or built into the design. In some cases, the camera 1010 may be located at the center of the device 1002. Within the device 1002, the camera 1010, the illumination feature 1011, and one or more optional channels 1012 may be located at the center of the combined device 1002. This configuration can be compact and relatively small in size. The inflatable tip (e.g., an inflatable balloon structural member) 1014 may be located near the center bundle of the device. The inflatable tip or inflatable balloon 1013 may be attached to the structural member 1014. This configuration may be advantageous in that the inflatable tip (or balloon) may not be visible in the camera. This may be because the relative positions of the camera module 1010 and the inflatable tip 10104 and / or balloon 1013 may be fixed within the device 1002. The inflatable tip 1014 or inflatable balloon 1013 may be within a designed distance from the camera 1010. The operator has a clear view of the anatomy and based on other indicators, namely proximal markings on the device, the operator knows the position of the inflatable tip or expandable balloon relative to the camera view.

[0230] Another example of an endoscopic rounded design may be the pre-curved device shown in device 1005. Device 1005 may include an endoscope 1036 and an inflatable tip 1037 including a balloon 1038.

[0231] Alternatively, the balloon may be designed to be flexible and / or articulated, as shown in device 1006. Device 1006 includes an endoscope 1040 and a flexible and / or articulated balloon.

[0232] Another example is an extra-circular configuration (device 1003). Such a configuration can have a pre-bent shaft (such as shown in 1006) or a flexible shaft (such as shown in 1009).

[0233] The side-by-side configuration and the circular design of the lens can provide the advantage of direct visualization. The operator can directly see the balloon and position it in the field of view when using the device. This feature can facilitate improved visualization and improved patient safety.

[0234] Integrated device with endoscope and implant delivery capability

[0235] In some examples, one or more disposable instruments may include an implant / stent delivery device. In some examples, the implant / stent delivery device may be configured to perform sinus surgery. In some embodiments, the device may include an implant / stent delivery device and an illumination source. In some examples, the device may further include a channel. In some examples, the device may further include an implant / stent delivery push mechanism. In some examples, the implant delivery device may be configured to deliver a prostate implant.

[0236] One or more instruments (e.g., disposable instruments) can include or be implant / stent delivery devices or equipment. Specially designed devices can be used to deliver various types of implants to a subject or subject's position under endoscopy. Several examples of this type of implant are described herein. As an example, the implant delivery portion of a combination device can have a form different from the example provided. All design examples described below can be applied to all other implants and delivery devices.

[0237] Sinus implant delivery

[0238] refer to FIG. 11 , an example device (e.g., device 1101) can include a side-by-side configuration having an endoscope 1117 and an implant delivery instrument (e.g., implant delivery tube) 1118 for performing sinus surgery. One or more cameras 1111 can be positioned at the distal end of the endoscope (e.g., endoscope 1117 in device 1101) and can be held stationary relative to the distal end of the implant delivery tube 1116. The implant delivery tube 1116 is an example instrument (e.g., a disposable instrument) that can be integrated with the endoscope to create the device.

[0239] Alternatively, in some cases, the position and / or orientation of the camera may not be fixed. In some cases, the position and / or orientation of one or more cameras may be adjustable. In some examples, the device may also include an illumination source (or illumination part) (e.g., illumination source 1112 in device 1101). In some examples, one or more instruments (e.g., one or more disposable instruments) may also include an illumination source. Implant delivery instrument / tube 1116 may be disposable or single use. Example device 1101 may be disposable. Illumination source 1112 may be disposable and / or single use. Implant delivery instrument / tube 1116 and illumination source may be integrated with endoscope 1117 (e.g., a disposable endoscope) to manufacture device 1101 as a single unit. In some cases, device 1101 may be disposable. In some cases, device 1101 may include some pieces and / or elements that may not be disposable.

[0240] refer toFIG. 10 , a device (e.g., device 1101) can optionally include one or more channels 1113. The system / device can include an implant 1114, which can be seated within an implant delivery instrument / tube 1116 or elsewhere on the device. The device can also include an implant delivery push mechanism 1115, which can be positioned proximal to the implant or elsewhere, and when activated, can push the implant 1114 out of the desired location in the sinuses or any other desired body part. The implant delivery instrument 1116 of device 1101 can be a sinus delivery instrument.

[0241] refer to FIG. 10 Another example of a device may include or be an extra-circular configuration (e.g., device 1102). In this case, the device (e.g., device 1102) may be configured to deliver different implants 1114. The camera module 1111 may be positioned at a distal end (such as the distal end of an endoscope) and may be fixed relative to the distal end of the external structure of the implant delivery instrument 1116.

[0242] Prostate implant delivery

[0243] refer to FIG. 10 , an example device can be designed as shown in example device 1108. This device 1108 can include various applications and uses, including, for example, delivering an implant to a subject's body. In some examples, the device can include application(s) for delivering a prostate implant to a patient's body or body part. This figure shows the implant delivery portion / instrument of this device. The implant delivery instrument of device 1108 can be a prostate delivery instrument. The device can include additional parts and components.

[0244] The device 1108 (eg, a combined or integrated device) may have a side-by-side configuration or a mirrored circular configuration (eg, according to the examples and figures described and shown anywhere herein).

[0245] Another example is FIG. 11The device 1109 can include an endoscope 1130, an implant delivery instrument 1116, an implant pushing mechanism 1115, a camera module 1111 at a distal tip of the endoscope 1130, an illumination source 1112, optional 1113, and optional other parts and / or pieces. The device can be configured to deliver an implant 1114. In the example device 1109, the camera 1111 and illumination parts 1112 can pass through a central opening of the implant 1114, the implant pushing mechanism 1115 of the device 1109, and the outer structure of the implant delivery instrument 1116 of the device 1109. This configuration can be compact in size. The device 1114 can be configured to or capable of performing the functions of both the implant delivery instrument and the endoscope. In some cases, the entire device can be disposable. The compact design can include various advantages for various purposes, such as intended surgical or inspection procedures.

[0246] Ear canal / implant delivery

[0247] In some examples, the devices provided herein can be used to deliver ear tubes, including, for example, tympanostomy tubes, ventilation tubes, pressure equalizing tubes, and / or other types of tubes for various applications.

[0248] Reference is made to FIG. 11 One example of a tube delivery device is shown as example device 1110. By replacing the implant delivery portion as shown in 1101 and 1102, the delivery portion can be part of a side-by-side configuration or an over-the-scope round configuration.

[0249] Reference is made to FIG. 11 An over-the-scope round configuration is shown as example device 1103. This design can be similar to the design shown in 1109. In some cases, FIG. 11 The side-by-side design shown in 1104 can have a pre-bent portion, which can be located at the neck region of the device or other locations, such as shown in 1104. A flexible (e.g., fully flexible) design with hinges is shown in 1106. The over-the-scope round design and the under-the-scope round design can have pre-bent portions, such as shown in 1105. Alternatively or additionally, they can have flexible designs, such as shown in 1107. FIG. 1 (107). FIG. 9 and FIG. 10 Other examples of flexible and hinged devices are shown. Such configurations can be combined with implant delivery devices as shown in FIG. 11 and can provide various designs and configurations.

[0250] Integrated device with endoscope and suturing capability

[0251] In some examples, one or more instruments (e.g., one or more disposable instruments) may include or be a suturing device (or mechanism), such as a device that may have suturing capabilities and may be configured to perform suturing. The suturing mechanism may be disposable. The suturing mechanism may be integrated into the device to form a single unit. The integrated unit including the endoscope and the suturing device or mechanism may be disposable.

[0252] refer to FIG. 12 , shows an example device 1201 having a side-by-side configuration. The device 1201 may include an endoscope 1220 and a suturing instrument / mechanism 1208. The camera module 1205 may be positioned at the distal end of the endoscope 1220 and may be seated proximate to the suturing mechanism 1208. In some cases, the position of the camera may be fixed on the device (e.g., relative to the suturing mechanism). The device / system 1201 may also include one or more illumination sources (or illumination parts) 1206. Optionally, the device may also include one or more channels 1207. The suturing mechanism 1208 may be custom made and may include one or more suturing needles 1209. Suture 1210 may be attached to the suturing needles 1209.

[0253] Another example may include an off-scope configuration as shown in example devices 1202 and 1204. The suturing mechanism 1208 may be present on the distal side of the endoscope (e.g., near the camera). In some cases, both the camera module 1205 and one or more instruments (such as the suturing mechanism 1208) may be located at the distal end (e.g., the distal end of the endoscope). Additional alternative designs and configurations are also possible.

[0254] Another example is shown as device 1203, which includes a circular configuration within the mirror. In device 1204, the camera module 1205, the illumination source (or illumination component) 1206, and the channel 1207 can be located in the center of the device. The device can have a rigid shaft, a pre-bent shaft, or a flexible articulated shaft. The design and configuration of the pre-bent shaft and the articulated shaft can be similar to any other shaft described herein (such as, FIG. 9 to FIG. 11 or elsewhere in this document) as provided herein.

[0255] Integrated device with endoscope and basic instruments

[0256] In some examples, the devices provided herein may include an endoscope and one or more basic instruments. The endoscope may be disposable. One or more basic instruments may be disposable. The device may include an integration of an endoscope and one or more instruments (e.g., one or more basic instruments that may be disposable). Thus, in some cases, the device may be disposable and single-use. The device may be configured to perform the functions of an endoscope and one or more basic instruments.

[0257] refer to FIG. 13 In some examples, for certain procedures and / or applications, other tools and / or instruments may be used with the endoscope. Examples of such instruments may include a laser fiber (e.g., shown in device 1303), a grasper (e.g., in device 1304), scissors (e.g., in device 1305), a snare (e.g., in device 1306), a loop (e.g., in device 1307), a barrel (e.g., in device 1308), a needle (e.g., in device 1309), other instruments, and / or any combination thereof.

[0258] For example, device 1313 includes endoscope 1320 and laser fiber 1322. The laser fiber (instrument) can be integrated with the endoscope as a single integrated device, and in some cases, the device can be disposable. The device can include any configuration, such as rigid, flexible / articulated, or pre-curved. In the example device 1313 shown herein, the endoscope includes a pre-curved configuration. In other examples, any of the instruments listed herein can be integrated with the endoscope in any configuration (e.g., any configuration provided herein).

[0259] One example of a side-by-side combination device is shown as device 1301. Camera 1310 can be located distally (such as at the distal end) and can be in a fixed position relative to fiber tip 1303.

[0260] The example device 1302 is shown in an off-scope circular configuration. The device may include a fiber tip 1303 or a laser fiber. Alternatively, the fiber tip may be replaced / exchanged with any other instrument, such as FIG. 13 The instruments shown in example instruments 1304-1309 in FIG.

[0261] refer to FIG. 11 In some examples, the device may include pre-bends 1313 and 1314. Flexible configurations with articulation are shown in example devices 1315 and 1316. A cable drive mechanism (not shown) may be positioned within the device (such as within an elongated member of an endoscope or within an instrument or within a shaft of an endoscope and / or instrument, as desired) to achieve articulation and flexibility for various purposes.

[0262] Integrated device proximal end and support member

[0263] FIG. 14A to FIG. 14E An example of an apparatus is shown in .

[0264] FIG. 14A An example of an ergonomic grip is shown in The device may include buttons 1406 (eg, for controlling a camera module, lighting source, and / or other instruments). FIG. 14AThe device shown in FIG. 1 may include a lever or slide 1407 that can facilitate control of articulation of the device (e.g., a combination device) at a given position (e.g., at its distal end). A fluid lure 1408 may be present to allow fluid inflow and outflow. The proximal end of the device may be attached (in some cases removably) to a support member. FIG. 8 The proximal end of an example device is shown in . FIG. 3 An example support member (handheld device) connected to the proximal end of an example device is shown in FIG.

[0265] In some examples, the device may include or be connected to a handheld device or handpiece (such as FIG. 3 ). Cable 1409 may be located at the proximal end of the handpiece and may be connected to an example display system.

[0266] The display system can be any type of display system, such as a computer, computing device, laptop, PC, iPhone, iPad, tablet computer, monitor, screen, LCD or any other display device or system. In some cases, multiple display devices or systems can be used.

[0267] FIG. 14B An example of direct grasping of a handheld device (or handpiece) is shown in . A lever or slide 1407 (or another mechanism) may be used to control articulation of the assembly at the distal end.

[0268] FIG. 14E Another example of a handheld device (or handpiece) is shown in FIG. In some examples, the device can include a knob 1411 (such as a rotation knob) that can be used to control the articulation of the device (e.g., a combined or integrated device). For an integrated implant delivery device (a device that includes an endoscope and an implant delivery device, such as any such device provided anywhere herein), a push rod 1410 can be available at the proximal end of the handheld device (or handpiece), which can allow for delivery of the implant.

[0269] Another example of transmitting power and images may be by wireless. FIG. 14E and FIG. 14D 14. A wireless module package 1412 is shown. The package may include a wireless transmitter and / or multiple batteries.

[0270] Provided herein are systems and methods for solving the medical conditions (such as, gynecological conditions or other conditions) of a subject (such as, animal and human subjects) and / or a subject's position (such as, any body part, organ or tissue of any subject). Provided herein are methods and systems that can be included in the application in various fields of the various conditions (health or disease) across the various parts of a subject (e.g., different body parts). Such applications can include gynecological applications, polypectomy, myomectomy, intrauterine device (IUD) delivery, uterine cancer treatment and other applications. For example, the subject's position to be treated, diagnosed, observed, inspected or treated can include sinuses, bladder, colon, esophagus, blood vessel, throat, brain, heart, lung, intestine, eyes, skin, liver, pancreas, stomach, kidney, ovary, testicle, bladder, ear, nose, mouth, bone marrow, adipose tissue, muscle, gland, mucosal tissue, spine, neural tissue, cartilage, teeth and bones.

[0271] In some examples, the present disclosure provides devices (such as disposable or single-use devices) with integrated visual capabilities (such as, one or more camera modules) to treat polypectomy, myelosurgery, IUD (intrauterine device) delivery, and other conditions.

[0272] The devices provided herein can include endoscopes. In some cases, the endoscopes provided herein can be disposable or single-use, which can provide several advantages over reusable endoscopes, as discussed anywhere herein. In some examples, the devices and systems can also include other instruments that can be integrated with them. Alternatively, such instruments can be used alone but in combination with an endoscope. Integrating such instruments with an endoscope (e.g., a single-use endoscope) can provide many advantages as described anywhere herein.

[0273] The devices and systems can be used to address, diagnose and / or treat various conditions in a subject or a portion of a subject. Subjects can include animals, mammals, rodents, and humans (such as patients). Conditions can include health conditions or disease conditions. For example, the devices and / or systems can be used for the diagnosis and / or treatment of polypectomy and / or myomectomy. The devices or systems can be used for the delivery of an intrauterine device (IUD). The devices and systems can be used for a variety of applications.

[0274] Polyps and fibroids may be considered common diseases in women, especially in old age. In some cases, these diseases may be related to and / or associated with abnormal uterine bleeding. The intrauterine device (IUD) is a contraceptive method widely used by women. In practice, minimally invasive surgical treatments for polyps (polypectomy) and fibroids (myomectomy) are often used. The same type of surgery can be used to place the IUD into the patient's body. These methods can include mechanical removal (polyps, fibroids) or placement (IUD), electrocautery devices for polyps or fibroids, morcellators for removing polyps or fibroids, etc. In many cases, a hysteroscope or resectoscope can be used to access the uterus. These endoscopes can be composed of multiple parts, including a sheath, a tube, a tool channel, and a water channel. In many cases, they may need to assemble several or all parts together before the surgical procedure. In some cases, treatment tools or instruments can be inserted into a device channel (such as an endoscope channel). For example, a morcellator can be inserted into an endoscope channel to perform a polypectomy or a myomectomy. The morcellator can include at least one myosure device, a truclear device, and / or other devices and / or instruments. However, it may be preferable to design a device that includes both the endoscope and the morcellator as a single integrated unit. Such devices are provided herein. For example, the device can include an endoscope and one or more instruments. The instrument can include or be the morcellator. The endoscope and / or one or more instruments can be disposable. The integrated device can be disposable.

[0275] In other scenarios, one or more instruments (e.g., one or more disposable instruments) may include or be an electrocautery device, such as a symphion device, TCRis, and / or other devices. The method may include using monopolar or bipolar energy to remove polyps or fibroids or treat other conditions. Other examples may include ablative (such as RF ablation or other) devices for the uterus. In some examples, any of the instruments listed herein may be integrated with an endoscope to create a single device that may be partially or completely disposable. In some examples, the instrument or tool may be disposable. In some examples, some instruments may be used that may not be disposable. Thus, in some cases, some portions of the device or the entire device may be reusable.

[0276] In some cases, the instruments can be laser-based, including the use of one or more types of lasers, such as green lasers, holmium lasers, or other types of lasers. For example, one or more instruments (e.g., one or more disposable instruments can include or be lasers, such as the lasers listed by way of example herein). In some examples, a device such as an IUD delivery instrument (such as a grasper) can be inserted into a channel of a scope to deliver an IUD. Such a device can be integrated with a scope to manufacture the device. The device can be integrated and disposable.

[0277] Various mechanical instruments can be used to mechanically remove polyps or fibroids. Examples can include graspers, scissors, snares, baskets, needles, etc. For example, needles can be used to deliver drugs or agents to a particular location. In other examples, needles can deliver steam or cryotherapy. One or more instruments (e.g., one or more disposable instruments) can include any of the instruments provided herein and / or any combination thereof.

[0278] In some examples, instruments can be designed to be low cost and / or single use for sterilization purposes. Conventional scopes are expensive, sometimes due to precision manufactured optics or other reasons. Scopes are traditionally manufactured with reusable components and can be used as equipment frequently. For reasons described anywhere herein, it is recognized herein that there is a need to develop single use / disposable scopes.

[0279] In some cases, a physician can need to assemble a reusable scope into a single use instrument / tool prior to a surgical procedure, or vice versa. After each procedure, the scope can need to be disassembled from other instruments and the scope and / or other parts and / or instruments cleaned and sterilized. Providing disposable and / or single use scopes can eliminate the need for such post-procedure cleaning. Further, providing integrated devices including a disposable scope and one or more instruments, such as disposable instruments or tools, can eliminate the need for user assembly according to any of the examples provided herein.

[0280] Traditionally, scopes can generally include channels (such as working channels) that can allow instruments to pass through and operate under the scope view. Alternatively, instruments can have a scope channel that allows the scope tube to be inserted and the instrument can operate under the scope view. For more commonly used disposable instruments, this combination can result in a mixed scenario where the scope can still need to be cleaned and sterilized. To improve clinical workflow and efficiency, it is desirable to have single use packaging of single use instruments and single use scopes. Such devices and systems are provided herein along with example methods of use.

[0281] When both the instrument and the endoscope are disposable or single-use, it may be desirable to integrate them into a combined device. It may be desirable to integrate such a camera onto the single-use device using a low-cost camera module to simplify the workflow of such a device. Integrating the instrument with vision capabilities can optimize the overall size of the device and reduce or minimize pain for the patient.

[0282] Traditionally, endoscopes may use a single lens or a stack of optical lenses. This can make flexible and soft endoscopes difficult to implement. For small, low-cost camera modules, a flexible and soft shaft may be desirable. This can improve patient comfort in many applications, such as polypectomy, myomectomy, and IUD delivery.

[0283] Integrated disposable devices with integrated instrumentation and visual capabilities may offer benefits such as sterilization, reduced costs, smaller overall size, improved patient comfort, better usability, and simpler workflow.

[0284] FIG. 15An example of a distal portion of a single-use (or disposable) integrated device that may also include visual capabilities is shown. An imaging module or camera module, such as camera sensor 1501, can be positioned distally or at another device location. In some cases, the camera sensor can include or be a low-cost camera sensor. The camera sensor can include a lens. For example, the camera sensor can include or be a complementary metal oxide semiconductor (CMOS) or complementary symmetric metal oxide semiconductor, or a charge coupled device (CCD), and / or other devices or components. Other camera modules and / or imaging devices can be used. In some examples, an integrated lighting device or component (such as a light source) can be attached to the distal tip 1502 or located in another device area / region. The lighting device or light source can include or be one or more of a light-emitting diode (LED), an optical fiber, a laser, an ultraviolet (UV) light source, or any other lighting device or light source that produces light of any wavelength and / or characteristics. The camera, camera sensor, camera module, and / or light source can be attached to the distal tip of the device or other device component, region, location, or area in various locations. In some cases, such devices or components can be permanently attached or located at a desired location or orientation. Alternatively, such a device or part may be removably attached or connected to such a device area (e.g., the distal tip of the device or other location on the device). In some cases, the camera module can be tilted at a given angle (e.g., inside the integrated device), which can be any angle, for example, 0, 12, 18, 30, 50, 60, or more. This can facilitate the creation of an endoscope with visual capabilities. Such visual capabilities can include a front view, a side view, a view from a single angle, a view from multiple angles, and the like. In some cases, multiple cameras can be mounted, attached, or connected to the same or multiple locations on the device at the same or alternating angles (any angle). The position and / or orientation of each camera can be fixed or adjustable. In some examples, data such as images, videos, or views collected or generated from one or more cameras attached to or mounted on the device can be combined or otherwise processed or used to form a 360° view of the environment in which the device or system is inserted or operates.

[0285] In some examples, the device may include an axis. In some examples, the axis may be a multi-lumen axis. Inside the axis (e.g., a multi-lumen device axis) 1503, one or more channels may be used to allow the crushing axis 1504 to move in a desired direction (e.g., axially into or out of the tip). Alternative directions may include vertical or at any angle. In some examples, the crushing axis may rotate radially along the axis. FIG. 16A and FIG. 16BTwo possible forms of a pulverizing shaft are shown. The pulverizing shaft is provided as an example. In other examples, one or more instruments (e.g., disposable instruments) such as those provided herein or tools may be used in place of the pulverizer.

[0286] In some examples, one or more channels (e.g., endoscope channels or working channels) can allow fluid to flow into or out of the body of a subject (e.g., a patient). A side view of a cross-section of such an example device is shown at 1506. The proximal end of the device is shown as a block at 1505. FIG. 3 More details of the proximal end and support member (eg, handheld device or handpiece) are shown in .

[0287] FIG. 2A and FIG. 2B An alternative distal portion of a single-use integrated device that may also include visual capabilities (such as a camera module) is shown. Similar to the arrangement in FIG5 , the camera module and illumination source may be attached to the distal tip. Alternatively, in some examples, the camera module, illumination source, and / or both may be located elsewhere on or off the device. In each case, such instruments, modules, and / or devices may be used in combination with the device (e.g., an endoscope, such as the disposable endoscopes provided herein). Reference FIG. 2A and FIG. 2B , near the camera module (or imaging module), the device may include an electrocautery delivery channel 201, an IUD delivery channel, or other one or more channels combined for the same and / or other functions or purposes. In other examples, such channels may be located / positioned in other locations, areas or zones on the device. The delivery channel 201 may be axially movable relative to the axis of the device. Alternatively, the delivery channel 201 may be vertically or radially movable relative to the axis of the device. As an example, FIG. 2B A cross-sectional view of the front surface 202 is shown in FIG.

[0288] FIG. 17A An example of a device (e.g., a single-use or disposable device) according to the systems and methods of the present disclosure is shown in FIG. In this example, the electrocautery device is positioned adjacent to the camera module. In other examples, one or more camera modules may be located in the same or other locations on the device. FIG. 17B Another example of a disposable device is shown in FIG. FIG. 17B As shown in FIG, one or more camera modules may be included in the device. In some cases, the camera module may be incorporated near a mechanical grasper that may be used as part of a device to treat a condition in a subject, such as treating polyps, fibroids, delivering an IUD or other device, or for other applications.

[0289] refer to FIG. 2A andFIG. 2B In some examples, channel 201 can accommodate mechanical, electrical, optical, or other energy devices, including, for example, graspers, scissors, snares, barrels, needles, monopolar, bipolar cautery instruments, radiofrequency (RF) ablation instruments, green laser fibers, holmium laser fibers, or other devices, equipment, and / or instruments.

[0290] In other examples, channel 201 can accommodate a needle for biopsy, steam delivery, cryotherapy delivery, drug delivery, or other purposes. Channel 201 can also be capable of accommodating other instruments for other purposes.

[0291] FIG. 15 as well as FIG. 2A and FIG. 2B The examples shown in can include rigid, semi-rigid, flexible, or articulated device shafts. In each case, the implant delivery channel can be rigid, semi-rigid, flexible, or articulated (e.g., articulated with two or more degrees of freedom).

[0292] FIG. 3 An example of the proximal side of the device is shown in . FIG. 6A and FIG. 6B Two examples of exemplary support members (e.g., handheld devices or handpieces) are shown in FIG. Inside the handpiece, as an example, the IUD delivery channel can have a stop (e.g., a hard stop) 301 along the axial direction. This can provide a safety stop to prevent the channel from being over-inserted into the subject's body.

[0293] The device may include a mechanical or electrical interface, such as a mechanical or electrical button. A button (such as a mechanical and / or electrical button) 302 may be located on the proximal side or other location on the device and may, for example, enable insertion of a morcellator shaft. Other uses of the button may include opening the mechanical grasper jaws or loading an IUD cassette. Other buttons may allow image capture, video recording, white balancing, or other applications and / or functions.

[0294] In some cases, a mechanism such as an internal mechanism may be in place for connecting a button (e.g., a mechanical button) to the pulverizer shaft insert or grasper jaws. Examples may include or be a hinge 305 that can connect a button (or buttons) 302 to the channel 300. This mechanism may include other forms that may be more complex. The mechanism may include mechanical and / or electrical mechanisms. In some examples, one or more interfaces 303 for fluid management may be provided at the proximal end of the device. Such interfaces may be bait connectors to allow fluid or other media to flow in and / or out.

[0295] The one or more interfaces may allow passage of an IUD instrument or other instrument, such as those mentioned elsewhere herein. Another use of the one or more interfaces may include, for example, allowing a separate, disposable endoscope to be inserted and / or snapped onto the rest of the device when the distal tip of the device does not have an integrated camera module. Alternatively, in some cases, the one or more interfaces may include allowing a separate, disposable endoscope to be inserted and / or snapped onto the rest of the device when the device does include a camera module at its distal tip or elsewhere.

[0296] In some examples, there may be a mechanical and / or electrical interface 304 to allow the device to connect to an image processing and / or display system, which may include or be a laptop PC (such as a laptop PC with a display monitor) or another device. Alternative options may include an imaging processing unit and / or display monitor.

[0297] Other ways of implementing a device with vision capabilities, such as an integrated device, may include an outer shaft with an electrocautery device, and may also include a camera module and / or lighting device / module / device / component within the outer shaft or elsewhere. FIG. 16A An example of such a design is shown.

[0298] For reasons of design simplicity or adaptability, the disposable (or single-use) camera module with illumination can be on a separate shaft that can be inserted into a channel (e.g., inside the device shaft) or other position or orientation. Once inserted, the camera module shaft can be snapped onto the device shaft, which can make it an integrated device. In this example, the camera module shaft can be removed from the integrated device. Other designs and / or configurations are also possible.

[0299] Although preferred embodiments of the present invention have been shown and described herein, it will be apparent to those skilled in the art that these embodiments are provided as examples only. Without departing from the present invention, those skilled in the art will now appreciate that many variations, changes, and substitutions may be made. It should be understood that in practicing the present invention, various alternatives to the embodiments of the present invention described herein may be employed. The following claims are intended to define the scope of the present invention and thus encompass methods and structures within the scope of these claims and their equivalents.

Claims

1. A device comprising: (a) An endoscope comprising: i) a disposable elongated member including a proximal end and a distal end; and ii) a camera module located at the distal end, wherein the proximal end is removably attached to a support member; and (b) one or more disposable instruments, said one or more disposable instruments being integrated into said endoscope, wherein the device is configured to perform the functions of both the endoscope and the one or more disposable instruments.

2. The device of claim 1, wherein the distal end is articulated with two or more degrees of freedom.

3. The device of claim 1, wherein at least one of the one or more disposable instruments is integrated into the endoscope via a permanent connection at the distal end.

4. The device of claim 1, wherein one or more pull wires are integrated into the wall of the elongated member.

5. The device of claim 1 , wherein the one or more disposable instruments are one or more instruments selected from the group consisting of a morcellator, scissors, a needle, an illumination source, a laser, a balloon, an implant / stent delivery device, a suturing device, a laser fiber, a grasper, a snare, a ring, and a barrel.

6. The apparatus of claim 1 , wherein there is substantially no relative movement between the camera module and the one or more disposable instruments.

7. The apparatus of claim 1 , wherein the camera module and the one or more disposable instruments are permanently integrated into the endoscope, and wherein there is substantially no relative movement between the camera module and the one or more disposable instruments.

8. The apparatus of claim 1, wherein the camera module is configured to provide a static view of the one or more disposable instruments.

9. A method comprising: An endoscope is provided, the endoscope comprising: a disposable elongated member including a proximal end and a distal end; and a camera module located at the distal end, wherein the proximal end is removably attached to a support member; providing one or more disposable instruments; and The one or more disposable instruments are integrated into the endoscope to form an integrated single device.

10. A device comprising: (c) An endoscope comprising: i) a disposable elongated member comprising a proximal end and a distal end, and wherein the proximal end is removably attached to a support member; and (d) a camera module; and (e) one or more disposable instruments, said one or more disposable instruments being integrated into said device, wherein the device is configured to perform the functions of both the endoscope and the one or more disposable instruments.

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