Endoscope system with off-center field of view

Abstract

The present invention relates to an endoscope system, which includes a computer system and a height display and a handheld portion. The handheld portion includes a reusable handle portion and a single-use portion configured to be discarded after a single use. The single-use portion includes a straight elongated cannula having an imaging module and an illumination module at its distal tip. The imaging module is mounted so that its direction of view (DOV) is at an oblique angle to the main longitudinal axis of the cannula.

Description

[0001] Citation of Related Applications

[0002] This patent application claims priority to U.S. Provisional Patent Application Serial No. 62 / 630,718 filed on February 14, 2018 and U.S. Formal Patent Application Serial No. 16 / 268,819 filed on February 6, 2019, which are incorporated herein by reference. All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated herein by reference. Technical Field

[0003] This patent specification relates to medical devices for tissue inspection and endoscopic surgery, such as for hysteroscopy and urology. More specifically, some embodiments relate to an endoscopic system that includes a disposable, single-use cannula and distal imaging module, and a reusable, multi-use handle and display tower. Background Art

[0004] Direct medical procedures, such as endoscopic procedures, are used to examine certain parts of the body, including internal anatomical structures. For example, hysteroscopy to examine the uterus, cystoscopy to examine the bladder, gastroscopy to examine the esophagus, stomach and / or small intestine, bronchoscopy to examine the throat, larynx, trachea and / or lower respiratory tract, sigmoidoscopy to examine the rectum, colonoscopy to examine the rectum and / or colon, colposcopy to examine the cervix, vagina and / or vulva, nasal endoscopy to examine the nasal and sinus passages, etc.

[0005] Traditionally, endoscopic procedures are performed with expensive equipment. Such equipment may include cystoscopes, hysteroscopes, and various other equipment. Such equipment may also include a display tower, which includes a camera control unit and a lighting control unit. Existing cystoscopes and hysteroscopes are typically reusable devices, with a metal cannula and an optical lens in a metal shaft. Other types of cystoscopes and hysteroscopes may include flexible, reusable devices, which are flexible cannulas, the articulation of the tip of which is typically controlled by a pull line and a joystick at the proximal end. After each procedure, the equipment may need to be sterilized, which may be costly or difficult to operate, and sterilization or disinfection may be ineffective. Recently, partially disposable endoscopes have become available, such as U.S. Patents 8,460,182 and 9,895,048.

[0006] An endoscope is an elongated tubular structure inserted into a body cavity to inspect the cavity. A conventional endoscope includes a telescope with an objective lens at the distal end. The telescope includes an image forwarding system. In a rigid endoscope, it is a series of spaced apart lenses. In a flexible endoscope, it is a bundle of tiny optical fibers coherently assembled to forward images. In a digital endoscope, which is usually a flexible scope, the imaging sensor may be located at the distal end of a flexible cannula. However, when the doctor manipulates the deflectable tip of the cannula with a camera (digital oscilloscope) in the patient's body, the view horizon may be lost, i.e. the doctor may lose orientation.

[0007] Therefore, it is desirable to overcome these challenges and provide a cystoscope and / or hysteroscope with a disposable cannula portion at a low cost. It would be desirable if such a device or system also captured images with a controllable horizontal view at a reduced cost. At least some of these goals will be met by the device described herein. Summary of the invention

[0008] According to some embodiments, an endoscope system is described, comprising: a computer processing system; at least one HD or VGA display connected to the computer processing system for receiving and displaying endoscopic images; and a handheld portion. The handheld portion includes: a multiple-use handle portion including a mechanical and electrical coupler; a cable for communicating with the computer processing system; and a disposable portion including a substantially straight elongated cannula having a central longitudinal cannula axis and a camera module mounted on a distal end, and a mechanical and electrical coupler that cooperates with the mechanical and electrical coupler of the multiple-use handle portion to assemble these portions into an integral endoscope. The camera module has a selectively tiltable direction relative to the cannula axis (DOV). According to some embodiments, the camera module is mounted to be movable relative to the cannula to selectively change the DOV. The camera module can be mounted offset from the central cannula axis, and the DOV is toward the central cannula axis. The disposable portion can be configured with a working channel to allow surgical devices to pass through the cannula and the distal tip. The distal tip can include a protrusion to accommodate the camera module, which is mounted in a manner to ensure that the system has a tilted DOV without increasing the cross-section of the distal tip protrusion. The cannula may be mounted for rotation about an axis relative to the proximal portion of the disposable portion and further include a manual control on a multiple use handle portion mechanically coupled to the cannula to effect cannula rotation.

[0009] According to some embodiments, an optical filter can be added at the distal end of the cannula to allow the camera module to use a specific wavelength of light narrower than the white light range for imaging. During medical procedures, the degree or nature of the system filtering can be changed by controlling the filter.

[0010] According to some embodiments, a sterile package may be provided for housing the disposable portion prior to a medical procedure. According to some embodiments, the single-use portion may include a housing having a distal portion and a proximal portion, the distal portion extending distally from the cannula, the proximal portion being mounted to the multiple-use handle via a coupler. The distal portion of the housing and the cannula may be mounted to rotate about an axis relative to the proximal portion of the housing.

[0011] According to some embodiments, the endoscope portion includes: an image processor and an image display; a multiple-use handle remote from the image processor and the image display; a cable connecting the multiple-use handle and the image processor; a disposable portion can be matched with the multiple-use portion through mechanical and electrical couplers to jointly constitute an assembled instrument for use in medical endoscopic surgery. The disposable portion includes a sleeve that is mounted to rotate about its longitudinal axis, and an imaging module at the distal end of the sleeve can selectively generate an image and transmit the image to the image processor through an electrical coupler and a cable for display on the display; a manual control device mounted on the multiple-use handle can be mechanically connected to the sleeve through a mechanical coupler, and the sleeve can be selectively rotated about the axis by manually operating the controller. The camera module can be mounted to have a viewing angle (DOV) that is angled relative to the axis. According to some embodiments, the disposable portion also includes a housing, from which the sleeve extends distally, and the housing has a proximal portion that is releasably fixed to the multiple-use handle and a distal portion that is fixed relative to the sleeve and rotates relative to the proximal portion of the housing.

[0012] According to some embodiments, a method is described, which includes: providing a multiple-use handle and a disposable portion in a sterile package, and, when removed from the bag, can be mechanically and electrically coupled to the multiple-use handle to form an assembled endoscope; inserting a cannula that is part of a disposable sleeve into a patient's body cavity, and using a camera module mounted at the distal end of the sleeve to capture an image, and transmitting the image to a display remote from the handle via a cable; mechanically coupling a control knob on the multiple-use handle to the sleeve via a mechanical coupler, and manually operating the control knob to selectively rotate the cannula in the patient's body cavity about the longitudinal axis of the multiple-use handle. According to some embodiments, the DOV of the camera module can be selectively controlled relative to the axial direction so that the DOV is at a selected angle relative to the axis. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The novel features of the present invention are particularly set forth 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 and accompanying drawings which set forth exemplary embodiments in which the principles of the present invention are utilized, wherein:

[0014] Figure 1An example of an endoscope system according to some embodiments is shown;

[0015] Figure 2A and Figure 2B shows a side view of a handheld portion of an endoscope system according to some embodiments;

[0016] Figure 3 is a perspective view showing further details of a distal tip of a handheld portion of an endoscope system for therapeutic use according to some embodiments;

[0017] Figure 4A is a perspective view showing further details of a distal tip of a handheld portion of an endoscope system for therapeutic use according to some embodiments;

[0018] Figure 4B is a cross-sectional view showing further details of the distal tip of a handheld portion of an endoscope system for therapeutic use according to some embodiments;

[0019] Figure 4C is a perspective view showing further details of a distal tip module of an endoscope system for therapeutic use according to some embodiments;

[0020] Figure 4D is a cross-sectional view showing further details of the distal tip of a handheld portion of an endoscope system for therapeutic use according to some embodiments;

[0021] Figure 5 is a cross-section of a cannula used in an endoscopic system for therapeutic use according to some embodiments;

[0022] Figure 6 is a front view of a distal tip of an endoscopic system for therapeutic use according to some embodiments;

[0023] Fig. 7A and Figure 7B shows a side view of a handheld portion of an endoscope system for diagnostic use according to some embodiments;

[0024] Figure 8 is a perspective view showing further details of a distal tip of a handheld portion of an endoscope system for diagnostic use according to some embodiments;

[0025] Fig. 9 is a perspective view showing some internal structures of a cannula for diagnostic endoscopy use according to some embodiments;

[0026] Fig. 10A and Fig. 10B are perspective and side views of a distal tip carrier module for use with an endoscope system for diagnostic use, according to some embodiments; and

[0027] Fig.11A and Fig. 11B Aspects of an endoscope system are shown for different directions of view according to some embodiments. Specific embodiments

[0028] A detailed description of an example of a preferred embodiment is provided below. Although several embodiments are described, it should be understood that the new subject matter described in this patent specification is not limited to any one embodiment or combination of embodiments described herein, but includes many replacements, modifications, and equivalents. In addition, although many specific details are set forth in the following description to provide a thorough understanding, some embodiments can be practiced without some or all of these details. In addition, for the sake of clarity, certain technical materials known in the relevant art are not described in detail in order to avoid unnecessarily obscuring the new subject matter described herein. It should be clear that the various features of one or several specific embodiments described herein can be used in combination with the features or other features of other described embodiments. Exceptions, the same reference numerals and designations in the various drawings indicate the same elements.

[0029] While some exemplary embodiments relate to a cystoscope and / or a hysteroscope, one skilled in the art will appreciate that this is not limiting and that the devices described herein may be used for other therapeutic or diagnostic procedures and other anatomical regions of a patient's body.

[0030] The embodiments disclosed herein may be combined in one or more of a variety of ways to provide improved diagnosis and treatment to patients. The disclosed embodiments may be combined with existing methods and devices to provide improved treatment, such as with known methods of urology or gynecology diagnosis, surgery, and, for example, surgery of other tissues and organs. It should be understood that any one or more structures and steps as described herein may be combined with any one or more additional structures and steps of the methods and devices as described herein, and the accompanying drawings and supporting text provide descriptions according to the embodiments.

[0031] Although the treatment plans described herein and the determination of treatment regimens and treatment doses are presented in the context of urological or gynecological diagnosis or surgery, the methods and devices described herein can be used to treat any tissue of the body and any organ and blood vessel of the body, such as the brain, heart, lungs, intestines, eyes, skin, kidneys, liver, pancreas, stomach, uterus, ovaries, testicles, bladder, ears, nose, mouth, soft tissue (such as bone marrow, adipose tissue, muscle, glandular and mucosal tissue), spinal cord and nerve tissue, cartilage, hard biological tissue (such as teeth, bones, etc.), and body cavities and passages (such as sinuses, ureters, colon, esophagus, lung passages, blood vessels and throat).

[0032] As used herein, a processor includes one or more processors, such as a single processor, or multiple processors such as a distributed processing system. A controller or processor as described herein typically includes a tangible medium to store instructions for implementing 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.

[0033] As used herein, the terms distal and proximal refer to positions referenced from the device, which may be opposite to anatomical references. For example, a distal position of a probe may correspond to a proximal position of an elongated member of a patient, and a proximal position of a probe may correspond to a distal position of an elongated member of a patient.

[0034] According to various embodiments, the device includes a probing portion that is inserted directly into a body cavity. The probing portion is brought into proximity with the tissue and / or area to be examined. As used herein, a probe includes an object that is inserted into a subject, such as a patient.

[0035] Figure 1 An example of an endoscopic system according to some embodiments is shown. System 2100 includes a handheld portion 2110 and a tower system 2112 interconnected via a cable 2132. Handheld portion 2110 includes a single-use, disposable portion 2120 and a handle portion 2130. Single-use portion 2120 is detachable from handle portion 2130 so that handle portion 2130 can be used multiple times. According to some embodiments, different version types of single-use portions may be made available. In the example shown, single-use portion 2120 is used for therapeutic purposes and includes a working channel (not shown) through which various devices (such as surgical devices) can pass. In some embodiments, several different single-use portions may be provided as a group, for example, a single-use portion for therapeutic purposes and a single-use portion for diagnostic purposes, or a group of single-use portions having different lengths and / or cannula diameters or internal lumen arrangements. In Figure 1Also shown is a diagnostic single-use portion 2122, which is primarily used for diagnostic purposes rather than therapeutic purposes and does not have a working channel. As will be described in further detail below, both the therapeutic single-use portion 2120 and the diagnostic single-use portion 2122 include an imaging module and an LED lighting module on their distal tips and one or more lumens for transporting fluids. The tower system 2112 includes a column 2140 mounted to a wheeled base 2142. The tower system 2112 also includes a display 2150, a keyboard 2160 and a mouse 2162, and a processing system 2170. According to some embodiments, the display 2150 can be touch-sensitive for receiving user input, and the display 2150 is high-resolution. According to some embodiments, the display 2150 is configured to display high-definition images at a pixel resolution of 1280×720, 1920×1080, 2048×1080, 2560×1440, 3840×2160, or higher. According to some embodiments, the processing system 2170 may be a suitable personal computer or workstation including one or more processing units 2174, input / output devices (such as a CD and / or DVD drive), internal memory 2142 (such as RAM, PROM, EPROM, and magnetic type storage media, such as one or more hard disks) for storing medical images and related databases and other information, and a graphics processor suitable for displaying graphics on a display 2150. According to some embodiments, the tower system 2112 is powered by a medical grade power supply (not shown). Figure 1 Shown are a sterile package or bag 2121 containing a single-use portion 2120 for therapeutic purposes, and a sterile package or bag 2123 containing a single-use portion 2122 for diagnostic purposes.

[0036] Figure 2A and Figure 2BA side view of a handheld portion of an endoscopic system according to some embodiments is shown. The handheld portion 2110 generally includes a reusable handle portion 2130 and a single-use portion 2120. According to some embodiments, the single-use portion 2120 can be delivered to a medical practitioner in a pre-sterilized package and is intended to be discarded after a single use, while the handle portion 2130 is designed to be reusable multiple times. As mentioned above, the single-use portion 2120 in this example is a single-use portion for treatment including a working channel. The single-use portion 2120 for treatment includes an elongated cannula 2240 with a distal tip 2250. The distal tip 2250 includes an imaging module 2252, a working channel distal port 2224, and a fluid port 2232. The working channel 2222 is shown in dashed outline and extends from the proximal port 2220 to the distal port 2224. According to some embodiments, the working channel has an inner diameter of about 3.2 mm, so that standard surgical devices can be set therein to perform various surgical procedures. Examples of such devices include: injection needles, forceps, tubes, knives, snares, probes, coagulator devices, brushes, laser devices, microwave devices (eg, for ablation), and photodynamic tools.

[0037] Cannula 2240 can be long, thin and semi-rigid. According to some embodiments, the cross section of cannula 2240 perpendicular to its main longitudinal axis is substantially circular. It should be noted that the cross section may have any suitable shape, such as an ellipse. The diameter of the cannula may vary according to the type of endoscope, such as from 1mm to 15mm. In addition to the working channel, cannula 2240 may have an internal structure for supporting various functions. For example, the cannula may include one or more fluid channels in fluid communication with various fluid ports. The cannula may include a common channel for inflow and outflow. Alternatively, the cannula may include two or more channels separated from inflow and outflow. According to some embodiments, cannula 2240 also includes a fluid cavity isolated from the working channel fluid. The fluid cavity may be in fluid communication with distal fluid port 2232 and proximal fluid port (such as fluid port 2230). According to some embodiments, another proximal fluid port is arranged on the opposite side of port 2230. The cannula 2240 is also configured to house a plurality of electrical conductors for providing power, control signals, and receiving video and image data from the imaging module and the illumination module at the distal tip 2250. In some cases, the conductors may be isolated and disposed in separate cavities within the cannula 2240, and in other cases, some or all of the conductors may be disposed in cavities that are also used for other purposes (e.g., fluid and / or device / tool ​​channels). According to some embodiments, one or more optical fibers may pass through the cannula 2240 for the purpose of data transmission and / or supplying illumination light to the distal tip 2250.

[0038] The handle portion 2130 is configured for multiple uses and is adapted to repeatedly receive a single-use portion. The handle portion 2130 includes a body that is sized and shaped to allow a safe and ergonomic grip by the operator's hand. The handle portion 2130 also includes a number of buttons that can be configured to allow common tasks to be performed during use, such as buttons 2212 and 2214. For example, buttons 2212 and 2214 can be programmed to control LED lighting levels (LEDs at the distal tip 2250, not shown), capture still images, and / or start and stop recording video images.

[0039] According to some embodiments, the cannula 2240 can rotate about its longitudinal axis relative to the handle portion 2130. In such cases, the handle 2130 can also include a cylindrical dial 2210 configured to rotate the lumen 2240 (and the distal tip 2250) along the dashed arrow. According to some embodiments, the distal portion 2242 of the housing 2241 surrounds the proximal portion 2244 of the cannula 2240 and rotates with the cannula 2240, while the proximal portion 2244 of the housing remains fixed relative to the handle portion 2130. Figure 2B How to install and remove the single use portion 2120 from the multiple use handle portion 2130 is shown. Specifically, the handle portion 2130 includes a socket 2260 that is sized to couple with a male mating portion 2261 that protrudes from the single use portion 2120. The action of installation and removal is represented by the dashed arrow 2266. Protruding from the mating portion 2261 are an electrical connector 2262 and a cannula 2264 that is used to provide rotation of the cannula 2240 when the dial 2210 is activated. According to some embodiments, the cannula 2264 has a "D" shaped cross-section or other shape that can provide a secure rotational connection between the cannula 2264 and a female socket (not shown) in the handle 2130.

[0040] According to some embodiments, handle portion 2130 can encapsulate or include components configured to process image data, generate control signals, provide power, or establish communication with other external devices. In some cases, communication can be wireless or wired communication. For example, wireless communication can include Wi-Fi, radio communication, Bluetooth, IR communication or other types of direct communication. In some embodiments, handle portion can be a housing sensor assembly for measuring the relative position between cannula and handle portion. In other embodiments, sensor assembly can measure the relative position or orientation of handle relative to its environment. The example of such sensor assembly will be further introduced below. In some cases, handle portion can have a display device as a user input device or have any type of user interaction component, such as button, mouse, joystick, trackball, touch pad, pen, image capture device, motion capture device, microphone or touch screen.

[0041] Figure 3 is a perspective view showing further details of the distal tip of the handheld portion of an endoscopic system configured for therapeutic use according to some embodiments. The distal side of the cannula 2240 and the distal tip 2250 can be seen. The distal tip 2250 includes an imaging module 2252 and an LED light source 2310. Fluid ports 2232 and 2332 and distal working channel port 2224 are also shown. According to some embodiments, the working channel port 2224 is also configured for inflow (flow of fluid out of the device and into the patient) and the fluid ports 2232 and 2332 are configured for outflow (flow of fluid into the device and out of the patient). Figure 3 Also visible in FIG. 2 is a slight protrusion or bump 2340 on the distal tip 2250 that rises slightly above the rest of the cannula 2240. The bump 2340 is configured to allow for angled mounting of the imaging module 2252 while still maintaining an overall low diameter of the cannula 2240 and distal tip 2250.

[0042] Figure 4A is a perspective view showing further details of the distal tip of a handheld portion of an endoscopic system configured for therapeutic use according to some embodiments. Visible in this exploded view is how the distal tip 2250 is attached to the cannula 2240. The distal tip 2250 includes a tip housing 2410 surrounding a distal portion tip module 2412. The proximal portion of the module 2412 is inserted into the distal side of the cannula 2240 and coupled thereto. The module 2412 may include a separate carrier 2414 on which the imaging module 2252 and LED 2310 are mounted. According to some embodiments, the carrier 2414 is not separate, but rather is integrated into the module 2412. It should be noted that in this example, the module 2412 is configured to hold the imaging module at a slightly downward viewing angle. That is, the imaging module 2252 is pointed downward so that its field of view is biased toward the distal port 2224 of the working channel, as shown in FIG. Figure 3 and Figure 4C shown.

[0043] According to some embodiments, tip housing 2410 can be made of a suitable material, such as an acrylic resin. In some cases, at least a portion of housing 2410 is transparent so that the line of sight of imaging module 2252 is not blocked by housing 2410, and the optical axis of imaging module 2252 is not aligned with the axis of cannula 2240 (e.g., Figure 4B). In some cases, one or more sides of the housing 2410 are transparent. In some cases, a portion of the side of the housing 2410 is transparent. In some embodiments, at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100% of the total surface of the housing 2410 is transparent. In some cases, other structures in the line of sight direction may also be made of transparent materials. The housing 2410 may be completely transparent so that the image captured using the optical components within the housing is not distorted or affected by the housing. In some cases, the housing 2410 may include an anti-glare or anti-reflective coating. The housing 2410 may or may not include a material that can filter out unwanted wavelengths of light. The housing 2410 may or may not be used as a secondary lens. The housing 2410 may or may not affect the field of view of the imaging device. According to some embodiments, enough of the housing 2410 is transparent to allow the use of an imaging device to capture a panoramic image. The optical components can be rotated at least 360 degrees without obstruction, such as by rotating the cannula 2240 about its main axis. In some cases, at least a portion of the housing 2410 can be opaque or selectively light-permeable so that illumination light from a distal illumination device (e.g., LED) can be filtered to achieve better imaging effects.

[0044] According to some embodiments, the imaging module 2252 includes an optical element and an image sensor for capturing image data. The image sensor may be configured to generate image data in response to the wavelength of light. Various image sensors may be used to capture image data, such as a complementary metal oxide semiconductor (CMOS) or a charge coupled device (CCD). In some cases, the image sensor may be disposed on a circuit board. The circuit board may be an imaging printed circuit board (PCB). The circuit board may include a plurality of electronic components for processing image signals. For example, a circuit for a CCD sensor may include an A / D converter and an amplifier to amplify and convert an analog signal provided by the CCD sensor. Optionally, the image sensor may be integrated with an amplifier and a converter to convert an analog signal into a digital signal, so that a circuit board may not be required. In some cases, the output of the image sensor or circuit board may be image data (digital signal), which may be further processed by a camera circuit or processor of the camera. In some cases, the image sensor may include an optical sensor array.

[0045] The imaging sensor of the imaging module 2252 may capture an image frame or a sequence of image frames at a specific image resolution. The image frame resolution may be defined by the number of pixels in the frame. The image resolution may be greater than or similar to approximately 352×420 pixels, 480×320 pixels, 720×480 pixels, 1280×720 pixels, 1440×1080 pixels, 1920×1080 pixels, 2048×1080 pixels, 3840×2160 pixels, 4096×2160 pixels, 7680×4320 pixels, or 15360×8640 pixels. The imaging sensor of the imaging module 2252 may have a pixel size no greater than 1 micron, 2 microns, 3 microns, 5 microns, 10 microns, 20 microns, etc. The imaging module may be, for example, a 4K camera or a camera with a higher resolution. The pixels of the camera may be square. Alternatively, the pixels may be non-square. The imaging device may capture color images, grayscale images, or non-white light images, among others.

[0046] According to some embodiments, one or more lenses, along with other optical components, may be used for different purposes to achieve various optical effects. Other optical components may include any type of optical element. For example, examples of optical elements may include filters 2484 (e.g., Figure 4B 2482). Examples of filters may include bandpass interference filters that can transmit a portion of the electromagnetic spectrum while rejecting all other wavelengths. One or more notch filters may be provided as examples of filter 2482. Notch filters can reject a portion of the spectrum while transmitting all other wavelengths. Edge or dichroic filters can transmit wavelengths greater than or shorter than a cutoff wavelength. Another example of filter 2482 may include a color substrate filter that can utilize the inherent absorption and transmission properties of the filter material. A neutral density (ND) filter can uniformly reduce transmission across a portion of the spectrum. In some cases, a UV / IR cutoff filter can be used to block infrared light and some UV light while allowing a full-spectrum camera to take normal photos. Examples of optical elements may include filters, mirrors, prisms, lenses, dichroic filters, beam splitters, optical fibers, or any other type of optical element. Optical elements can cause light to pass through, reflect light, scatter light, refract light, focus light, filter light, or perform any other action on light. Any optical element or combination of optical elements may be provided. According to some embodiments, the filtering of optical filter 2482 is electronically controllable. In this case, the filtering can be controlled by using a button on handle 2130 (e.g. Figure 2A and Figure 2B Button 2212 or 2214 shown) to provide filtering controls.

[0047] The optical assembly of the imaging module 2252 may also include components for adjusting the optical path. In some embodiments, the optical assembly may include a zoom lens with a variable focal length or viewing angle.

[0048] One or more light sources can be positioned at distal tip 2250. One or more light sources can be light emitting diodes (LEDs), organic LEDs (OLEDs), quantum dots, or any other suitable light sources. In some cases, the light source can be a dual tone flash LED lighting device. The light source can be any other suitable optical lighting delivered by an optical fiber from a light source in a disposable cannula, handle, or any other part of the device.

[0049] Figure 4B is a cross-sectional view showing further details of the distal tip of a handheld portion of an endoscopic system configured for therapeutic use according to some embodiments. The shaft on a conventional endoscope may have an optical prism positioned within a rod lens at an angle near the distal end to suit many applications. For example, the optical prism may provide directions of view (DOV) at various angles (e.g., 30 degrees, 70 degrees, or any value between 0 and 180 degrees) to expand the field of view. However, when the imaging sensor is located at the distal tip, such an optical prism may result in very large packaging at the distal end or greatly increase the cost of the imaging module. According to some embodiments, a device with multiple DOVs is provided by positioning the imaging device at various angles so that the optical axis of the imaging device intersects the longitudinal axis of the cannula at the imaging device. For example, as Figure 4B As shown, imaging module 2252 can be positioned such that an optical axis (i.e., DOV) 2420 of imaging module 2252 is tilted by a DOV angle θ relative to an axis 2422 of cannula 2240. According to some embodiments, DOV angle θ is equal to 0, 5, 10, 12.5, 15, 20, 25, 30, 35, 40, 45, 50, 55, 50, 55, 60, 65, 70, 75, 90, 120, 150, up to 180 degrees or any value therebetween. Figure 4C is a perspective view showing further details of the distal portion tip module 2412.

[0050] The imaging module 2252 has a suitable size and dimension to be enclosed in the distal tip 2250. In some cases, the maximum dimension of the imaging module is approximately less than or equal to the following dimensions (e.g., length, width, height, diameter, diagonal): 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 5.5 mm, or any value up to 100 mm. According to some embodiments, the imaging module 2252 has a diameter or "height" of approximately 1.6 mm. The cross-section of the imaging module is approximately less than or equal to the following dimensions (which can refer to the transverse cross-sectional area enclosed by the imaging device): 50 cm 2 、10cm 2 , 5cm 2 , 2cm 2 , 1cm 2 、0.01cm 2 or less. In some cases, the imaging module may weigh no more than 0.5 kg, 0.1 kg, 0.05 kg, 0.01 kg, 5 g, 1 g, or less. The total volume of the imaging module is approximately equal to or less than the following dimensions: 250 cm 3 , 200cm 3 、175cm 3 、150cm 3 、125cm 3 , 100cm 3 、75cm 3 , 50cm 3 、40cm 3 、30cm 3 , 20cm 3 、15cm 3 、10cm 3 , 5cm 3 , 1cm 3 , 0.1cm 3 、0.05cm 3 or less.

[0051] According to some embodiments, the Figure 4B DOV angle θ is shown. Angle θ can be fixed during operation of device 2100. Alternatively or additionally, angle θ can vary during operation. In some cases, the imaging device can be attached to an attachment device of the distal tip at a desired angle prior to insertion. Alternatively, the imaging device is rotatably coupled to the distal side so that the angle can be adjusted during operation of the device. The imaging device can be attached or coupled to the distal tip via any suitable attachment device, such as using an adhesive (e.g., glue), a fastener (e.g., a bolt), a complementary mechanical feature, or a combination of the above.

[0052] Figure 4Dis a cross-sectional view showing further details of the distal tip of a handheld portion of an endoscopic system configured for therapeutic use according to some embodiments. In this case, the distal tip cover 2410 and module 2412 are replaced with a single molded tip module 2490. Using a single component can save space because less wall is used. Using a single molded tip module 2490 allows a DOV angle θ of approximately 12 degrees, a working channel 2222 of 3.6 mm, an imaging module height of 2.4 mm, and an overall diameter of approximately 6 mm without any bumps or protrusions (such as Figure 4B The bumps 2340 shown in FIG.

[0053] Figure 5 is a cross-section of a cannula used in an endoscopic system configured for therapeutic use, according to some embodiments. Figure 5 The cannula 2240 is shown along Figure 4B 25. The outer wall 2510 of the cannula 2240 has three fluid-separated cavities: a working channel 2222, a secondary fluid cavity 2522, and a cable cavity 2520. As described, the working channel 2222 is used to allow the passage of surgical devices. According to some embodiments, the working channel 2222 is also used to transport fluids. The fluid cavity 2522 is also used to transport fluids. According to some embodiments, the working channel 2222 is configured to be used via Figure 2A , Figure 3 and Figure 6 The distal working channel port 2224 is shown for inflow (for fluid flow out of the device and into the patient), and the fluid lumen 2522 is used to Figure 3 The fluid ports 2232 and 2332 are shown to flow out (to allow fluid to flow into the device and out of the patient). The cable lumen 2530 is configured to accommodate a plurality of electrical conductors for providing power, control signals to, and receiving video and image data from, the imaging module and the illumination module at the distal tip 2250. According to some embodiments, one or more optical fibers may pass through the lumen 2522 for the purpose of data transmission and / or supplying illumination light to the distal tip 2250.

[0054] Figure 62 is a front view of the distal tip of an endoscopic system configured for therapeutic use according to some embodiments. The working channel port 2224, the imaging module 2252, and the LED 2310 are shown in this view. The protrusion 2340 is also shown. According to some embodiments, the maximum value of the protrusion 2340 extending above the upper surface of the cavity 2240 and the tip 2250 is about 0.35 mm. When the height of the imaging module 2252 is 2.4 mm, the DOV angle θ is about 12 degrees. According to some embodiments, if the height of the imaging module is about 1.6 mm, the distal tip may not need the protrusion 2340. According to some embodiments, if the height of the imaging module is greater than 2.0 mm, the DOV angle θ is greater than 10 degrees, and the height of the protrusion 2340 is between 0.1 mm and 0.5 mm.

[0055] Fig. 7A and Figure 7B 21 shows a side view of a handheld portion of an endoscope system configured for diagnostic use according to some embodiments. In this case, the handheld portion 2110 includes a reusable handle portion 2130 and a single-use portion 2122 for diagnostic use. It should be noted that many of the components of the single-use portion 2122 are similar to those of the endoscope system. Figure 2A , Figure 2B , Figure 3 Figure 4 Figure 5 and Figure 6 The components of the single-use portion 2120 shown and described with respect to the drawings are similar or identical. Many embodiments for the single-use portion 2120 shown in these figures and described herein are also applicable to the single-use portion 2122, and will not be repeated for the sake of clarity. According to some embodiments, the single-use portion 2122 can be delivered to a medical practitioner in a pre-sterilized package and is intended to be discarded after a single use, while the handle portion 2130 is designed to be reusable multiple times. As mentioned above, the single-use portion 2122 in this example is a single-use portion for diagnosis that does not include a working channel. The single-use portion 2122 for diagnosis includes an elongated cannula 2740 with a distal tip 2750. The distal tip 2750 includes an imaging module 2752 and a distal fluid port 2724.

[0056] Cannula 2740 can be long, thin and semi-rigid. According to some embodiments, the cross section of cannula 2740 perpendicular to its main longitudinal axis can be substantially circular. It should be noted that the cross section can have any suitable shape, such as an ellipse. The diameter of the cannula can be different according to the type of endoscope, such as from 1mm to 15mm. Cannula 2740 can have an internal structure for supporting various functions. For example, the cannula can include one or more fluid channels in fluid communication with various fluid ports. The cannula can include a channel shared by inflow and outflow. Alternatively, the cannula can include two or more channels with separate inflow and outflow. The fluid cavity can be in fluid communication with distal fluid port 2724 and proximal fluid port (such as fluid port 2730). Cannula 2740 is also configured to accommodate a plurality of electrical conductors, which are used to provide power, control signals and receive video and image data from the imaging module to the imaging module and lighting module at the distal tip 2750. In some cases, the conductors may be isolated and disposed in separate lumens within the cannula 2740, in other cases, some or all of the conductors may be disposed in a lumen that is also used for other purposes (e.g., fluid and / or device / tool ​​channels). According to some embodiments, one or more optical fibers may pass through the cannula 2740 for the purpose of data transmission and / or supplying illumination light to the distal tip 2750.

[0057] According to some embodiments, the cannula 2740 can rotate about its longitudinal axis relative to the handle portion 2130. In such cases, the handle 2130 can also include a cylindrical dial 2210 configured to rotate the lumen 2740 (and the distal tip 2750) along the dashed arrow. According to some embodiments, the distal portion 2742 of the housing rotates with the cannula 2740, while the proximal portion 2744 of the housing remains fixed relative to the handle portion 2130. Figure 7B How the single use portion 2122 is installed and removed from the multiple use handle portion 2130 is shown. Specifically, the handle portion 2130 includes a socket 2260 that is sized to couple with a male mating portion 2760 that protrudes from the single use portion 2120. The action of installation and removal is represented by the dashed arrow 2766. Protruding from the mating portion 2760 are an electrical connector 2762 and a shaft 2764 that is used to provide rotation of the cannula 2740 when the dial 2710 is activated.

[0058] Figure 84 is a perspective view showing further details of the distal tip of the handheld portion of an endoscopic system configured for diagnostic use according to some embodiments. Visible is the distal side of the cannula 2740 and the distal tip 2750. The distal tip 2750 includes an imaging module 2752 and an LED light source 2820. Two fluid ports 2724 are also shown. According to some embodiments, one fluid port is configured for inflow (flowing fluid out of the device and into the patient) and the other fluid port is configured for outflow (flowing fluid into the device and out of the patient). Similar to the distal tip 2250 (e.g., shown in FIG. 4), the distal tip 2750 is a separate component attached to the cannula 2740. The distal tip 2750 includes a tip housing 2810 surrounding a distal portion tip module (not shown). The proximal portion of the distal tip module is coupled to the distal side of the cannula 2740. The carrier 2814 holds the imaging module 2752 and the LED 2820. It should be noted that in this example, carrier 2814 is configured to hold imaging module at a slightly downward DOV angle. That is, imaging module 2752 has a downwardly pointing DOV such that its field of view is biased toward fluid port 2724.

[0059] Fig. 9 29 is a perspective view showing some of the internal structures of a cannula configured for diagnostic endoscopic use according to some embodiments. In this view, three lumens can be seen. Lumen 2910 is used to carry wires that connect the imaging module and LEDs to electrical connector 2762. Lumens 2912 and 2914 are configured for use in proximal fluid ports (e.g., Fig. 7A and Figure 7B Fluid is transported between 2730) in the middle and distal fluid port 2724.

[0060] Fig. 10A and Fig. 10B are perspective and side views of a distal tip carrier module for use with an endoscope system configured for diagnostic use, according to some embodiments. Fig. 10A The carrier 2814 is shown having a central slot 1010 for holding the imaging module 2752 at a downwardly inclined angle. On either side of the slot 1010 are slots 1016 that also hold the LED unit 2820 at a downwardly inclined angle. A circular channel 1014 is formed in the carrier 2814 for accommodating a plurality of LED units 2820 for use in the handle portion 2130 (e.g., Figure 1 and Fig. 7A One or more wires that carry power, control signals, data and / or image signals between the imaging module and the LED. Fig. 10A Also shown is a lower wall 1012 that separates the two fluid chambers 2912 and 2914 in the cannula 2740 (eg, Fig. 9 shown). Fig. 10BImaging module 2752 and cable 1020 are shown in dashed outline held by carrier 2814. Fig. 10B The DOV angle θ is also shown.

[0061] In embodiments that allow for changing angle θ, imaging module 2252 or 2752 may be mounted for sliding movement along a curved track. Fig.11A and 11B Aspects of an endoscope system with different directional fields of view according to some embodiments are shown. Fig.11A In FIG. 1 , the track 1120 is curved so that when the imaging module 2752 is advanced in the distal direction along the track 1120, the angle θ increases, and when the imaging module 2752 is pulled in the proximal direction along the track 1120, the angle θ decreases. Fig.11A θ2>θ1. If sufficiently stiff, the cable 1020 can be used to push and pull the imaging module 2252 or 2752. Alternatively, the cable 1020 can be reinforced by appropriate inserts or external coatings, or a separate stiff wire 1130 can be used to push or pull the imaging module 2752, thereby changing the angle θ. The cable 1020 or a separate stiff wire can extend from the imaging module 2252 or 2752 to a manually operated button or joystick on some or all of the single-use portions 2120 and 2122 or 2740. Fig. 11B A label 1140 is shown mounted near the proximal cannula 2740. The label 1140 is secured to the hardwire 1130. The label 1140 is manually operated to select or change the angle θ. This selection may be made at the time of manufacturing the single-use portion, prior to commencing a medical procedure in which the single-use portion is to be used, or during a medical procedure. Optionally, an alternative structure for selecting and changing the angle θ may use a cam mount and control wire for the imaging module, the control wire coupling the imaging module to an upper button or joystick on the proximal portion of the single-use portion and configured such that manually operated button or joystick moves the imaging module along the cam to change the angle θ as desired. Another optional structure includes a rotating device for the imaging module 2750, the rotating device enabling the imaging module to rotate about an axis transverse to the longitudinal axis of the cannula in response to operation of a similar cable or wire, thereby changing the angle θ as desired. It should be noted that in Fig.11A and 11B In the case of a cannula, a thin layer of flexible and stretchable material 1134 can be added to prevent liquid from leaking into the lumen of the cannula. Material 1134 can be soft rubber or other suitable material. Soft material 1134 is adhered to the edge of the cannula tip structure 2814 and surrounds the edge of the imaging module. When the imaging module 2752 moves, the thin flexible and stretchable material can prevent liquid from leaking into the lumen of the cannula.

[0062] 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 by way of example only. Without departing from the present invention, those skilled in the art will appreciate that many variations, changes and replacements are possible. It should be understood that various alternatives to the embodiments of the present invention described herein may be used to practice the present invention. The following claims are intended to define the scope of the present invention, and thus cover methods and structures within the scope of these claims and their equivalents.

Claims

1. An endoscope system, comprising: Computer processing systems; having at least one high-definition or VGA display electrically connected to the computer processing system to receive and display endoscopic images; as well as The handheld part includes: a multiple-use handle portion having mechanical and electrical couplings for receiving the single-use portion and a cable electrically connecting it to the computer processing system; as well as a single-use portion including a straight elongated cannula having a central longitudinal cannula axis, an imaging module mounted distally, and an electromechanical coupler that mates with the electromechanical coupler of the multiple-use handle portion to releasably assemble into a complete endoscope; The distal tip of the cannula comprises a tip module and a tip housing surrounding a distal portion of the tip module, a proximal portion of the tip module is inserted into and coupled to the distal side of the cannula, the tip module comprises a carrier, the carrier comprises a curved track, the imaging module is mounted on the carrier for sliding movement along the curved track; The imaging module has a selected direction of view (DOV) relative to the central longitudinal cannula axis, and the imaging module is configured to move in a distal direction or a proximal direction relative to the carrier within the cannula along the curved track to change the DOV.

2. The endoscopic system of claim 1, wherein the imaging module selectively varies the DOV with movement of the cannula.

3. The endoscopic system of claim 1, wherein the imaging module is mounted offset from the central longitudinal cannula axis and the DOV is directed toward the central longitudinal cannula axis.

4. The endoscopic system of claim 3, wherein the single-use portion is configured with a working channel to allow a surgical device to pass through the cannula and the distal tip.

5. An endoscope system according to claim 1, wherein the cannula rotates around a central axis relative to the proximal portion of the single-use portion, and further includes a manual control device located on a multiple-use handle portion, the multiple-use handle portion is mechanically coupled to the cannula, and the cannula is rotated by operation of the manual control device.

6. The endoscope system of claim 1, further comprising a filter located distal to the cannula, the filter causing the imaging module to capture a selected wavelength range of light, the selected wavelength range of light being narrower than the range of white light.

7. The endoscopic system of claim 6, further comprising a control for filtering configured to vary the degree or nature of filtering when the system is used in a medical procedure.

8. The endoscopic system of claim 1, further comprising a sterile package that contains the single-use portion prior to use in a medical procedure.

9. The endoscope system according to claim 1, wherein: The single-use portion includes a shell having a distal portion and a proximal portion, the cannula extending from the distal portion, and the proximal portion is mounted to the multiple-use handle portion via the connector, wherein the distal portion of the shell and the cannula rotate relative to the proximal portion of the shell about the central longitudinal cannula axis.

10. An endoscope comprising: Image processor and image display; a multiple-use handle portion remote from the image processor and the image display; a cable connecting the multi-use handle portion and the image processor; a single-use portion that mates with the multiple-use portion via an electromechanical coupling to form an assembled instrument for use in medical endoscopic procedures; The single-use portion includes a cannula that rotates about its longitudinal axis, and an imaging module located distally for selectively generating an image, the imaging module transmitting the image to an image processor via the electrical coupling and cable for display on the display; a manual control mounted on the multiple-use handle, the manual control mechanically coupled to the cannula via the electromechanical coupling to enable selective rotation of the cannula about the axis by manual operation of the control device; The distal tip of the cannula comprises a tip module and a tip housing surrounding a distal portion of the tip module, a proximal portion of the tip module is inserted into and coupled to the distal side of the cannula, the tip module comprises a carrier, the carrier comprises a curved track, the imaging module is mounted on the carrier for sliding movement along the curved track; The imaging module has a selected direction of view (DOV) relative to the longitudinal axis of the cannula, and the imaging module is configured to move in the cannula along the curved track in a distal direction or a proximal direction relative to the carrier to change the DOV.

11. The endoscope according to claim 10, wherein: The single-use portion also includes a shell, which includes a proximal portion and a distal portion, the cannula extending distally from the distal portion of the shell, the proximal portion being releasably fixed to the multiple-use handle, and the distal portion being fixed relative to the cannula and rotating together with the cannula relative to the proximal portion of the shell.

12. The endoscope according to claim 10, wherein: The distal tip of the cannula includes a protrusion.

13. The endoscope according to claim 12, wherein: The protrusion is rounded and a portion of the imaging module is inserted into the protrusion, thereby providing space for forming a DOV without increasing the cross-sectional area of ​​the protrusion at the distal portion of the cannula.

14. The endoscope according to claim 10, wherein: The imaging module is mounted for movement to selectively vary the DOV during a medical procedure using the cannula.

15. The endoscope of claim 10, comprising a sterile package, wherein the single-use portion is packaged in the sterile package prior to being removably assembled with the multiple-use portion.

16. The endoscope of claim 10, further comprising an optical filter that selectively passes a wavelength of light required by the imaging module.

17. The endoscope according to claim 16, wherein: The filter selectively changes the range of wavelengths transmitted to the imaging module.

18. A computer processing system for use in an endoscope system according to any one of claims 1 to 9, comprising one or more processing units, an input / output device, an internal memory, and a graphics processor, wherein the computer processing system is used to perform the following method: Providing a multiple-use handle and a single-use portion in a sterile bag, wherein when removed from the bag, the single-use portion and the multiple-use handle closely cooperate with each other through an electromechanical coupling to form a combined endoscope; inserting a cannula, which is part of the single-use portion, into a body cavity of a patient, capturing an image with an imaging module at a distal end of the cannula, transmitting the image to a monitor remote from the multiple-use handle via a cable, and displaying the image; A control knob on the multiple-use handle is mechanically coupled to the cannula via the electromechanical coupling, and the cannula is selectively rotated relative to the multiple-use handle about its longitudinal axis by manually operating the control knob while the cannula is in the body cavity.

19. The computer processing system of claim 18, further configured to: selectively control a direction of view (DOV) of an imaging module relative to the longitudinal axis to achieve a DOV at a selected angle relative to the longitudinal axis.

20. The computer processing system of claim 18, further configured to perform: changing the cross-section of the distal portion of the cannula by providing an outward protrusion, the protrusion housing a portion of the imaging module.

21. The computer processing system of claim 18, further configured to execute: in the single-use portion, the shell has a distal portion and a proximal portion, the cannula extends distally from the distal portion, and the rotation of the cannula includes rotating the cannula and the distal portion of the shell relative to the proximal portion of the shell.

Images