Disclosure of Invention
According to one aspect of the present invention, there is provided a portable endoscope having a side-engaging disposable member comprising (a) a reusable handle comprising an elongate side channel located laterally of the reusable handle, the side channel extending along the longitudinal axis of the endoscope; a display module with a screen to display an image, the display module mechanically mounted to the reusable handle and rotatable and/or pivotable relative to the reusable handle, a signal processing circuit located within the reusable handle to cooperate with the display module, a first electrical connector located on the handle to cooperate with the signal processing circuit, (b) a single use disposable component comprising a receptacle configured to removably snap into the side channel and be movable away from the side channel in a direction transverse to the longitudinal axis of the endoscope, a cannula extending from the receptacle to a front end, wherein the cannula is configured to rotate relative to the receptacle along the longitudinal axis of the endoscope, a first lumen extending from a first rear end port along the longitudinal axis of the endoscope, the first lumen beginning at a rear end of both the receptacle and the handle and ending at a front end portion of the cannula, an imaging and illumination module located at a front end of the cannula, a second electrical connector configured to removably snap into the side channel and to be movable away from the side channel in a direction transverse to the longitudinal axis of the endoscope, a cannula extending from the receptacle, wherein the cannula is configured to extend from a first rear end port along the longitudinal axis of the endoscope, the first lumen begins at a rear end portion of the receptacle and the handle, and terminating at least one of the imaging and illumination module is configured to be coupled to the signal processing module and the signal processing module, and the control module are configured to be coupled to the signal processing module, to selectively cause the imaging and illumination module to illuminate a field of view and capture an image, the display module displaying the image.
According to some embodiments of the invention, the side channel in the reusable handle extends from the rear end of the handle to the front end of the handle;
In some embodiments, the handle includes an outer wall of a plurality of components that are sufficiently sealed from one another to repeatedly steam sterilize the handle. The portable endoscope having a side-on disposable member further includes a removable plug for repeated steam sterilization, the plug sealing the first electrical connector to seal the handle;
In some embodiments, the first electrical connector is configured to circumscribe an external device to transmit an image captured by the imaging and illumination module, the external device being one or more of a workstation and an image archiving and/or transmission unit;
In some embodiments, the portable endoscope having a side-facing disposable member further comprises a cable electrically connecting the second electrical connector to the imaging and illumination module, wherein the cable has a front end portion inside the cannula and a rear end portion outside the cannula and the hub, the rear end portion of the cable being sufficiently long and flexible that the cannula is rotatable relative to the handle about the longitudinal axis of the endoscope by at least 180 degrees when the hub is snapped into the side channel of the handle and the first electrical connector is connected to the second electrical connector;
in some embodiments, the portable endoscope having a side-engaging disposable member further includes a second rear end port extending proximally from the rear ends of the socket and the handle when the socket is snapped into the side channel of the handle.
In some embodiments, the portable endoscope with the side-on disposable member further includes an intermediate port that is distal to the handle and proximal to the forward end of the cannula when the hub is snapped into the handle.
In some embodiments, the portable endoscope having a side-facing disposable member further includes a second lumen extending along the longitudinal axis of the endoscope and in fluid communication with the first rear port and at least one port other than the first rear port.
In some embodiments, the first port and the first back port are on the same vertical plane as the center of the display module and the linear distance is less than 15cm, thereby maintaining the display module and the first back port in the same view and angle as viewed by the user.
In some embodiments, the handle comprises a rechargeable battery, wherein the first electrical connector is electrically connected to the battery, and the battery is recharged through the first electrical connector.
In some embodiments, the signal processing circuitry in the handle includes WiFi circuitry, and further includes an antenna configured to wirelessly transmit images captured by the imaging and illumination module.
According to another aspect of the present invention there is provided a single use endoscope disposable component comprising a hub elongated along a longitudinal axis, a cannula extending distally from the hub, wherein the hub is configured to detachably snap into an elongate side slot of a reusable handle and be movable away from the side slot in a direction transverse to the longitudinal axis, the cannula being configured to rotate along the longitudinal axis relative to the hub, a first lumen extending along the longitudinal axis from a first rear end port beginning at a position rearward of the hub and terminating at a front end portion of the cannula, an imaging and illumination module located at a front end of the cannula, an electrical connector working in cooperation with the imaging and illumination module, a cable electrically connecting the imaging and illumination module with the electrical connector, wherein the cable has a front end portion inside the cannula and a rear end portion outside the cannula and the hub, the rear end portion being sufficiently long and flexible to enable rotation of the cannula at least 180 degrees about the longitudinal axis relative to the hub.
According to another aspect of the present invention there is provided a portable endoscope having a side-engaging disposable component comprising a reusable handle with a pistol grip for convenient handling by a user, an elongate side channel located on one side of the reusable handle above the pistol grip and extending along a longitudinal axis of the handle perpendicular to the direction of the pistol grip, a socket removably snap-fit with the side channel, a cannula having an imaging module at its forward end extending distally from the socket, a display module mounted on an upper portion of the handle for rotation and/or pivoting relative to the handle, an image processing circuit located inside the handle for working in cooperation with the display module for displaying images transmitted from the imaging module, an electrical connector located on the handle for working in cooperation with the image processing circuit for receiving images captured by the imaging module located at the forward end of the cannula.
According to another aspect of the invention there is provided a method of imaging a patient comprising providing a cannula extending distally from a hub along a longitudinal axis of the cannula, the cannula and hub constituting a single use disposable member of an endoscope, providing a handle as a reusable portion of an endoscope, the handle having a side slot extending from a rear end to a front end of the handle in the direction of the longitudinal axis, the handle connecting a display module, the display module rotating and/or pivoting relative to the handle, snapping the hub into the side slot of the handle such that the hub extends from the rear end to the front end of the handle, electrically connecting an imaging module located at the front end of the cannula and circuitry of the handle, the circuitry electrically connecting the display module, the electrical connection comprising a cable connecting the imaging module and a first connector, the hub being provided with a second connector connecting the first connector, the cable having a distal portion passing through the interior and exposing the image module and the hub to a selected area of the user in the environment, capturing an image of the user, and exposing the image sensor to the selected area of the handle.
In some embodiments, the method of imaging in a patient further comprises making the exposed portion of the cable long enough to rotate the cannula at least 180 degrees relative to the hub and the handle.
In some embodiments, the handle is repeatedly sterilized with steam.
In some embodiments, the handle further comprises several portions of the outer wall that are sealed to each other using O-rings and/or gaskets for steam sterilization.
In some embodiments, a fluid port is provided adjacent the handle and the hub, and a lumen extends along the longitudinal axis from the port to the forward end of the cannula.
As used herein, the grammatical expressions "and", "or" and/or "are intended to indicate that there may or may not be one or more choices of the situation, object, or subject matter to which they are connected. In this way, as used herein, the term "or" in all cases means a meaning of "exclusive or" rather than an exclusive or.
As used herein, the term "surgical" or "procedure" refers to any physical intervention to patient tissue and does not necessarily involve cutting patient tissue or closing a previously existing wound.
Detailed Description
A detailed description of the preferred embodiments is provided below. While several embodiments are described, it should be understood that the novel subject matter described in this patent specification is not limited to any one embodiment or combination of embodiments described herein, but includes many alternatives, modifications, and equivalents. Furthermore, although numerous specific details are set forth in the following description in order to provide a thorough understanding, some embodiments may be practiced without some or all of these details. Moreover, for the sake of clarity, certain technical material that is known in the prior art has not been described in detail to avoid unnecessarily obscuring the novel subject matter described herein. It should be clear that each feature of one or several of the specific embodiments described herein may be used in combination with features of other described embodiments or other features. Further, like reference numbers and designations in the various drawings indicate like elements. All issued and filed patents mentioned in the detailed description are given reference indices in this patent specification.
Fig. 1 and 2 are right and top views of a portable endoscope having a disposable member according to some embodiments. The portable endoscope 100 includes an elongated cannula 120 with a front end 110 that is insertable into a hollow organ or cavity of a human body. According to some embodiments, front end 110 is connected to cannula 120 as a separate front terminal assembly. According to some embodiments, the diameter of the front end 110 is greater than about 4.55mm. For more details on the separate front terminal assembly of a hand-held endoscope, see U.S. patent No.9,895,048 (hereinafter "048 patent")), filed on publication No. 15/462,331,2017, 3-17, U.S. patent publication No. 2017-0188793A1 (hereinafter "331 application")), and filed on publication No. 2018, 1-23, PCT/US18/14880, international patent application No. WO0/2018/136950 (hereinafter "880 application"). Front end 110 includes an imaging module and at least one LED light source for viewing the interior of the organ or lumen into which front end 110 is inserted. Front end 110 also includes one or more fluid ports.
According to some embodiments, cannula 120 is rigid, flexible, or semi-flexible, and includes one or more fluid channels that are fluidly connected to port 132. The port 132 includes a luer fitting to allow a leak-free connection of the port 132 to various medical fluid components (not shown). One or more fluid channels or lumens in cannula 120 connect to one or more forward-facing fluid ports of forward end 110. According to some embodiments, one or more fluid channels or lumens in cannula 120 are also connected to back end ports 130 and 430. The back end ports 130 and 430 also include luer fittings to allow for leak-free connection with various medical fluid components (not shown). According to some embodiments, the rear end port 130 is substantially in line with the main longitudinal axis 124 of the cannula 120, thereby providing a substantially straight passthrough for a rigid or semi-rigid instrument. According to some embodiments, only one back-end port 130 is provided and the second back-end port 430 is omitted. The ease of instrument insertion and manipulation may be enhanced by port 130 through the instrument channel with a straight rear end portion. It has been found that the instrument ports (i.e., ports 130 and/or 430) can be configured to generally match the display module 150 and are perpendicular to the center of the display module 150, with significant ergonomic benefits. This arrangement makes it easier to insert a surgical instrument into port 130 or 430 and to manipulate the instrument because the instrument is in the same view and at the same angle as the display screen with respect to the user's eye. In particular, the short distance between the port and the display screen allows the operator to limit his/her visual range to a relatively small area. According to some embodiments, the distance d between the back end port (in this case, port 130) and the center of the screen 350 of the display module 150 is less than about 15cm. According to some embodiments, the distance d is less than about 12cm. According to some embodiments, the distance d is less than about 10cm.
According to some embodiments, all three ports 130, 132, and 430 are connected to the same lumen or channel within cannula 120, and in other embodiments, the ports are connected to two or more separate lumens. One or more "duckbill" or similar valves may be used to prevent backflow or leakage when two or more ports are connected to the same lumen in cannula 120. According to some embodiments, wires extending from the LED light sources and camera modules in front end assembly 110 connect electrical connectors 136 through separate channels within one cannula 120, with at least 1 fluid channel within cannula 120. The electrical connector 136 is configured to form a detachable electrical connection with a handle electrical connector 144 on the handle 140. In the vicinity of the fluid port 132 are a seat 134 and a socket 138. According to some embodiments, the receptacle 138 is a sliding (i.e., snap) fit with a side slot in the handle 140 (see side slot or slot 440 in fig. 4A).
The endoscope 100 includes a handle 140 that is pistol-shaped in size and shape to be easily grasped in the manner of a gun by an endoscope operator (e.g., a doctor or other medical professional). The display module 150 is rotatably and/or pivotably mounted on the handle 140 by means of bearings, which may be slide bearings made of plastic and rubber-wrapped hinges. An image capture button 142 is also visible on the handle 140. According to some embodiments, the handle 140 and the display module 150 may be reused and constitute the reusable portion 402 (shown in fig. 4A and 4B). According to some embodiments, the handle 140 includes one or more electronics modules 146 that include at least one of camera control, video capture, video processing, video/data storage, battery charging and control, touch screen processing, and WiFi communication. According to some embodiments, the electronics module 146 includes an electronic imaging system that supports automatic adjustment of parameters such As Exposure Control (AEC), gain control (AGO), and white balance (AWB). In addition, the electronics module 146 provides Automatic Light Control (ALC) to control the illumination of the object to be imaged. The camera and illumination modules in the front end 110, along with the imaging and control in the electronics module 146, are configured as a "well-conditioned" imaging system, providing a useful "auto mode". According to some embodiments, the handle 140 is similar to that shown and described in the ' 048 patent, the ' 331 application, and the ' 880 application, all of which are generally gun-type handles, which may contain electronic components and cooperate with a display, but differ significantly in the present application in the detachable connection and interaction of the handle 140 with the disposable member 400.
Fig. 3 is a perspective view of a portable endoscope having a side disposable member of some embodiments. The endoscope 100 shown in the figures includes only one back end port 130. In other embodiments, different disposable members 400 may be made according to the specific needs of the user. In some embodiments, the injection needle of the disposable member emerges from the cannula tip in a manner similar to that described in U.S. patent No.10,278,563, or the cannula of the disposable member has a flexible front end similar to that described in U.S. patent application Ser. No. 16/447,251 filed on 6/20 of 2019, or the cannula of the disposable member includes a working channel through which a surgical instrument can pass, or the cannula front end of the disposable member is made to scratch or otherwise collect a tissue sample similar to that described in U.S. patent No.8,460,182. As indicated by the dashed arrow, according to some embodiments, cannula 120 may be rotatable about its longitudinal axis 124.
Fig. 4A and 4B are further perspective views of a portable endoscope with a side-mounted disposable member in some embodiments. Fig. 4A more clearly shows a single-use disposable member 400 and a multi-use reusable portion 402 of endoscope 100. Single-use portion 400 includes cannula 120, front end 110, electrical connector 136, ports 130, 132, and 430, and hub 138. The reusable portion 402 includes the handle 140 and the display module 150. Single-use portion 400 slides or snaps into the sides of reusable portion 402 in a radial direction along longitudinal axis 124 as indicated by the dashed arrow. In particular, the receptacle 138 of the single-use portion 400 is sized to closely fit but be removable with the side slot 440 in the handle 140 of the reusable portion 402. The mating connection of the insert housing 138 with the side slots 440 provides a secure physical connection between the single-use portion 400 and the reusable portion 401. The electrical connection between the two portions 400 and 402 is established using the electrical connector 136 and the handle electrical connector 144. Advantages of separating the physical connection from the electrical connection have been found to include better resistance to fluid contamination of the electronic components, and easier, more intuitive mating of the single-use portion and the reusable portion. In addition, this type of electrical connection may be conveniently selected to connect single-use portion 402 to an electronic unit such as a cabinet, rather than handle 140. The cabinet may contain computing devices and displays, or other image processing and/or image storage devices, or devices that transmit images from 402 to a remote location (e.g., a hospital workstation or a telemedicine facility). According to some embodiments, the electrical connector 136 connects to the single-use portion 400 via a flexible cable 414 and enables the cannula to rotate as indicated by the dashed arrow in fig. 3. The front end portion of cable 414 is inside cannula 120, but the rear end portion is outside, exposed to the environment, and is of sufficient length and flexibility to allow cannula 120 to rotate relative to base 134 and handle 140.
Fig. 4B shows more details of the physical and electrical connections between the single-use portion and the reusable portion of portable endoscope 100. According to some embodiments, the electrical connectors 136 and 144 use standard electrical connection schemes such as micro display ports (type DP 20) for the 1 and 2 generation lightning interfaces. Fig. 4B shows a male connector 410 that mates with a female connector 144 on the handle 140. With respect to the mechanical connection, the receptacle 138 may include positioning aids, such as positioning balls 460, 462 and 464, which are spring loaded and may engage with the internal grooves 442 and 444 formed in the side grooves 440. In addition, posts 450 and 452 are provided on the receptacle 138 and apertures 470 and 472 are provided on the inside of the side slot 440 of the handle 140 to mate therewith.
FIG. 5 is an exploded view of a portable endoscope having a side-facing disposable member and a fluid resistant handle portion, depicting sealing components and other aspects, according to some embodiments. Many of the components of reusable portion 402 are sealed with O-rings and/or gaskets, including both left and right handle flaps 542 and 540 sealed to each other with corresponding O-rings or gaskets 532. Similarly, the front cover 550 and the rear cover 552 of the display module 150 are sealed using O-rings 534. The display module 150 and the left handle cover piece 542 are sealed using an O-ring 551. Various other openings are sealed with O-rings (e.g., O-ring 530). Similarly, the front cover 581 and the bottom cover or flap 583 may be sealed to the left and right handle flaps 540 and 542 by O-rings and/or gaskets.
Fig. 5 also shows a main printed circuit board 570 on which the electronic module 146 is mounted. The lithium ion rechargeable battery 580 supplies power to the electronic components, the display module 150, and the front-end camera module and the LED lamp through the electrical connector 144. In some embodiments, wi-Fi functionality is also included, as shown in fig. 5 for WiFi motherboard 582 and WiFi antenna 584.
Fig. 6 is a perspective view of a sealing structure and other aspects of a portable endoscope having a side disposable member in accordance with some embodiments. In this view, O-ring seals 532 and 534 are shown. The O-ring seal shown and described in fig. 5 and 6 provides a high degree of water resistance to the reusable portion 402 of the portable endoscope. For example, the handle 140 may conform to the IXP 7 standard and may be submerged from 0.15 meters to 1 meter below the liquid level for up to 30 minutes. After use, the reusable portion of the endoscope is sterilized and/or disinfected prior to reuse to prevent cross-contamination. The seal as shown and described employed by the reusable portion 402, according to some embodiments, can also have a level of fluid resistance in a fluid infiltrate such as alcohol for cleaning, sanitizing, and/or sterilizing. According to some embodiments, reusable portion 402 may be sterilized by immersion in Ethylene Oxide (EO) using a removable silicone plug (not shown) or otherwise sealing electrical connector 144. According to some other embodiments, reusable portion 402 can withstand repeated high pressure environments, such as a hot steam environment at 134 ℃.
Fig. 7 is a perspective exploded view of a cannula rotating structure and other portions of a portable endoscope with a side mounted disposable member, according to some embodiments. At the front end, the front end 110 is shown to include an end mount 710, two or more LEDs (LEDs 720 and 722 are shown as an example only), and a camera module 730. The rear end of cannula 120 is inserted into the front end of fluid collection chamber 732. The collection chamber 732 is secured at a rear end to the pedestal 134, and the pedestal 134 is secured at a rear end to the base 750. Within the housing 134 is an insertion tube connector 746, the front end of the insertion tube connector 746 being configured to be insertable into the rear end of the insertion tube 120. The rear end of the connector 746 is connected to a connector 744, which connector 744 may be attached to the connector 746 by threads and/or epoxy. The link 744 is connected to the working channel link 742. The base 750 is held in place by being "sandwiched" between the rear end of the channel connector 742 and the flange on the connector 740. The connector 740 is connected to the tube 754. The rear end of tube 754 is secured to luer port 756. Tube 754 is configured to freely rotate within receptacle 138. The receptacle 138 and electrical connector 136 remain stationary relative to the handle 140 while most other components rotate about the axis 124. In particular, according to some embodiments, front end 110, cannula 120, collection chamber 732, mount 134, connectors 746 and 744, working channel connector 742, base 750, connector 740, tube 744, and luer fitting 756 are rotated together as a unit about axis 124. According to some embodiments, the rotational amplitude of cannula 120 and other components is limited to slightly less than 360 degrees (e.g., 350 degrees as shown in fig. 8B, or at least 180 degrees) so that flexible cable 414 does not become too tight due to over-rotation. The base 750 may include a tab 752 that may be inserted into a circular slot 810 (shown in fig. 8A) on the front face of the flange of the receptacle 138.
Fig. 8A and 8B are a cross-sectional view and a front view of a portable endoscopic cannula rotation structure and other portions with a side-mounted disposable member in accordance with some embodiments. In some embodiments, circular slot 810 can limit rotation of cannula 120 and other components by limiting movement of base 750 tab 752 (shown in fig. 7). Note that since the cannula contains multiple lumens, the working channel in the cannula may be slightly off-center or off-axis 124. The link 744 allows the working channel to be more closely located to the centrally located longitudinal axis 124.
Fig. 9 is a side view of a WiFi antenna arrangement and other aspects of a portable endoscope with a side mounted disposable member in accordance with some embodiments. The locations of the WiFi motherboard 582 and the WiFi antenna 584 are shown. Note that WiFi antenna 584 may extend to and along the back of the touch screen of display module 150 to reduce the shielding effect of the metal portion of handle 140. According to some embodiments, the WiFi module and antenna 584 on the motherboard 582 may transmit video to a WiFi receiver (not shown), such as in another external monitor or workstation.
Fig. 10 is a perspective view of a touch sensitive video display screen according to some embodiments. As described above, the electronics module 146 in the handle 140 includes an electronic imaging system that supports automatic adjustment of parameters such As Exposure Control (AEC), gain control (AGC), and white balance (AWB). In addition, automatic illumination control (ALC) is integrated with ALC (automatic illumination control) for controlling illumination of the imaged object. The camera and illumination modules in the front end 110, along with imaging and control in the electronics module 146, together are configured as a "well-conditioned" imaging system, which can provide a useful "auto mode". However, in some cases, the use of a "manual mode" is sometimes advantageous, especially in endoscopy. In the hand-held portable endoscope 100, the automatic mode works well in most cases when the front end 110 is inside the cavity. But in some cases, for example, when the camera on the front end 110 is close to the inner wall of the tissue tangential to the line of sight of the camera module, the partial image field (due to the inner wall being close to the illuminating LED) is very bright compared to other areas farther from the LED. To better visualize the inner wall (or the portion near the camera head), a "manual mode" may be used, while all automatic imaging functions are turned off. In fig. 10, a switch button, such as one of the corner position buttons 1020, 1022, 1024, and 1026 on the touch screen 350, can switch or toggle the automatic mode and the manual mode. According to some other embodiments, hardware buttons on the handle 140 may be used in addition to or instead of the touch screen buttons to switch between automatic and manual modes. In addition, the "manual mode" may have a2 or 3 shift to reduce the LED brightness to facilitate visualization of the target surface. Such an automatic mode and manual mode arrangement is described in U.S. patent No.10,292,571.
According to some embodiments, the automatic mode is configured to enable full automatic AGC, AEC and ALC, while the manual mode turns off AGC, AEC and ALC and sets the LED brightness to 50% of its default brightness (or other preset brightness, e.g., 75%). Screen 350 is a non-contact or non-touch operation such that the clinical operator does not have to remove his glove to push and activate buttons on screen 150. According to some embodiments, buttons 1020, 1022, 1024, and 1026 are virtual touch buttons that float above display 350. As shown, they may be located near corners or edges of the screen. The user may move (slide) the "X" or "+" pattern laterally at position 1030 on screen 350 to close and hide the floating button. The user may dial the floating button in a circular motion (not shown) on the screen.
Fig. 11A and 11B are cross-sectional views of an insertion tube in some embodiments, and a cross-sectional view of a front end portion of a portable endoscope having a side-mounted disposable member. Fig. 11A illustrates some example dimensions of cannula 120. Cannula 120 has an outer diameter of 4.1 millimeters. The working channel lumen inner diameter is 2.2 millimeters and the cable lumen 1102 is oval in shape and size as shown. The cable lumen 1102 may be used to carry cables to the camera module and LEDs on the front end 110. In fig. 11B, the size and position of camera module 730, leds 720 and 722 are shown. The side length of the square area of the camera module 730 is 1.05mm, and the LEDs 720 and 722 are rectangular, and the long side length thereof is approximately the same as the side length of the camera 730.
According to some embodiments, the endoscope 100 described herein may be applied to gynecological diseases. For example, an endometrial biopsy device like Pipelle, an endometrial biopsy cannula like SoftFlex provided by Intel Hiragana Life sciences, new Jersey (INTEGRA LIVE SCIENCES Corp.), an endometrial sampler (EndoSampler) such as Meter gold, illinois (MedGyn), and a surgical curet, etc., may be inserted through the working channel into the body for an endometrial biopsy.
Although the foregoing has been described in some detail for purposes of clarity of illustration, it will be apparent that certain changes and modifications may be practiced without departing from the principles of the invention. It should be noted that there are many alternative ways of implementing the processes and apparatuses described herein. Accordingly, the present embodiments are to be considered as illustrative and not restrictive, and the body of work described herein is not to be limited to the details given herein, but may be modified within the scope and equivalents of the appended claims.