A kit for clinical operation of minimally invasive percutaneous nephrolithotomy, a sterile kit for minimally invasive percutaneous nephrolithotomy, and a disposable kit for salivary gland endoscopy

Abstract

A kit includes a first disposable part and a second disposable part, wherein the first disposable part is releasably coupled to a reusable part and is used to penetrate into the kidney and / or ureter of a patient and view the working area and the guide wire passing through the first disposable part through an electronic display during a first stage of a PCNL clinical procedure; the second disposable part is releasably coupled to the reusable part and is used to view the working area and surgical tools for treating the area through an electronic display during and after treatment during a second stage of a PCNL clinical procedure after the first disposable part is retrieved from the patient. Another kit includes a disposable instrument for salivary gland endoscopy.

Description

[0001] Citation of Related Applications

[0002] This application claims the benefit of Provisional Application Nos. 63 / 522,395 filed on June 21, 2023 and 63 / 521,704 filed on June 19, 2023, and is a continuation-in-part of each of the following original applications: (a) No. 17 / 720,143 filed on April 13, 2022; (b) No. 17 / 521,397 filed on November 8, 2021; and (c) No. 17 / 370,575 filed on July 8, 2021.

[0003] The entire contents of the aforementioned patent applications are incorporated herein by reference in their entirety, and this application claims the benefit of the filing dates of and the benefits required by each of the applications and the applications that are directly or indirectly incorporated by reference into it (including U.S. provisional applications, U.S. non-provisional applications, and international applications). Technical Field

[0004] This patent specification generally relates to a portable, handheld endoscope that is wholly or partially disposable. Background Art

[0005] Percutaneous nephrolithotomy (PCNL) is a clinical procedure to remove stones or perform other procedures on a patient's kidneys and / or ureters. In some instances, the location of the stones is determined by retrograde pyelography. Slow injection of contrast medium under fluoroscopic monitoring to visualize each filled calyx helps determine the location of the posterior calyx. Next, in the first phase of the procedure, a PCN needle is passed through the skin and soft tissue into the renal pelvis. Imaging modalities such as fluoroscopy or ultrasound are used to confirm the location of the needle. A guidewire is passed through the needle into the pelvis. The needle is then withdrawn, leaving the guidewire in the pelvis. One or more dilators are passed over the guidewire and a working sheath is placed. The nephroscope is then passed inside to remove the stone (most likely first fragmented) or to perform other clinical procedures on the kidney or ureter. A nephroscope is an optical instrument that can be used to examine the renal cavitary system and perform different therapeutic procedures under direct visual control. The nephroscope contains an optical system for viewing the working area and a working channel into which lithotripters or different working elements (lithotomy forceps, stone extraction probe, etc.) can be inserted. Flushing fluid can also flow in this axial channel. Fluid returns through the space between the nephroscope and its sheath. The procedure can last 3-4 hours. Conventional nephroscopes are not disposable and therefore require thorough decontamination between patients, which shortens the life of the instrument. Existing nephroscopes have an optical path for viewing the working area, and the surgeon needs to view the working area through an eyepiece connected to the nephroscope, which limits the surgeon's body and head position and viewing angle.

[0006] Salivary gland endoscopy is a minimally invasive procedure used to diagnose and treat salivary gland diseases, including stones, strictures, chronic inflammation and other problems affecting the major salivary glands. Reusable instruments are provided by Karl Storz (Tuttlingen, Germany) and other companies, which can be flexible, semi-flexible or rigid, and can be used only for viewing and diagnosis, or can include surgical instrument working channels. Such existing instruments are not disposable, so they need to be thoroughly decontaminated when used between patients, which shortens their service life, generates more personnel and equipment costs, and still cannot completely eliminate the risk of cross contamination. For a discussion of existing instruments, see the following literature, the contents of which are part of this patent specification by reference: Iro H, Zenk J, Koch M and Bozzato A, The Erlangen Salivary Gland Project, Part 1, Endo Press GmbH, Erlangen, Germany, 2005 (printed in 2007), ISBN 978-3-89756-149-6.

[0007] The subject matter described or claimed in this patent specification is not limited to embodiments that overcome any particular disadvantages or operate only in the above-described environment. Rather, the above background is only used to illustrate an exemplary technical field in which some embodiments of the utility model can be practiced. Utility Model Content

[0008] As originally claimed but subject to amendments made during the prosecution of this patent application, according to some embodiments, a kit for PCNL clinical procedures includes two different disposable portions, each for use at different stages of the clinical procedure. At each stage, a reusable portion is coupled to the disposable portion, allowing the user to view an electronic image of the work area. This can greatly reduce the risk of contamination, eliminate the time, personnel and equipment costs required to decontaminate a reusable nephroscope, and by viewing the electronic image, the surgeon's freedom of movement can be increased and fatigue can be reduced.

[0009] Furthermore, after the needle is inserted under fluoroscopic or ultrasound guidance, it is very important that the target location can be visually confirmed through the optical field of view at the needle tip, and the embodiments disclosed in this patent specification can achieve this without the need for additional insertion of a nephroscope or the use of tools to insert a guidewire.

[0010] According to some embodiments, a kit for clinical operation of minimally invasive percutaneous nephrolithotomy (PCNL) includes: a first disposable part, including a first handle; a first cannula extending distally from the first handle and having a sharp distal end; a first channel extending from a first proximal port in the handle to a first distal port in the cannula, for inserting a guide wire so that it passes through and extends distally out of the first channel; and a first imaging module located at the distal end of the first cannula, including a first light source and a first image sensor; a second disposable part, including a tube hub; a second cannula extending distally from the tube hub; and a second imaging module located at the distal end of the second cannula, including a second light source and a second image sensor; wherein the first cannula is used to be inserted into or into a patient's kidney and / or ureter, and the first imaging module is used to capture a first image of the patient's part in a first stage of the clinical operation, and the first image selectively includes The kit further comprises a first path for transmitting the first image from the first imaging module to the reusable portion during the first clinical operation; and a second path for transmitting the second image from the second imaging module to the reusable portion during the second clinical operation.

[0011] According to some embodiments, the kit may further include one or more of the following: (a) a sterile package, wherein the sterile package encapsulates the first and second disposable portions for transporting the kit to a user and storing it until needed for PCNL operation; (b) the second cannula may include a flexible distal portion, wherein the flexible distal portion is bendable in a direction away from the long axis of the second cannula, and the reusable portion may include a motor, wherein the motor is operably coupled to the flexible portion to bend the flexible portion in a selected direction and at a selected angle under manual control of the motor operation; (c) The reusable portion may have a side opening, with an axis extending transversely along the long axis and rotatable by a motor, and the tube hub may include a gear that cooperates with the axis in the second stage of clinical operation; (d) the tube hub may include a finger control device, wherein the finger control device is operably coupled to the flexible portion and is used to bend the flexible portion in a selected direction at a selected angle after a force is applied to the finger control device; (e) the first disposable portion can be retrieved from the patient's body through a guide wire after the first stage of clinical operation, leaving the guide wire in the patient's body, and further includes a trocar, wherein the trocar is used to insert the trocar into the patient through the guide wire. (f) the first path may include a connecting line, wherein the connecting line is operably coupled to the first imaging module, extends from the proximal end of the first handle, and terminates at the first connector, and the reusable portion may include a matching connector, wherein the matching connector is used to electrically contact the first connector, transmit power from the reusable portion to the first disposable portion, and transmit the first image to the reusable portion; (g) the first path may include a wireless connector, wherein the wireless connector is located at the first disposable portion. (h) the second path may include an electrical connector in the tube hub and an electrical connector in the reusable part, wherein the electrical connectors are operably matched with each other in the second stage of clinical operation, thereby supplying power from the reusable part to the second imaging module and transmitting the second image from the second imaging module to the reusable part in the second stage of clinical operation; (i) the first handle may be pencil-shaped, sized to be handheld, and may extend along the long axis of the first cannula; and (j) the first cannula may be a straight tube.

[0012] According to some embodiments, a sterile kit for minimally invasive percutaneous nephrolithotomy (PCNL) includes a first disposable part and a second disposable part for performing a single PCNL clinical operation on a patient, wherein: the first disposable part includes: a first handle; a first cannula extending distally from the distal end of the first handle, having a sharp distal end, and made of a sufficiently hard material to penetrate the patient's skin and soft tissue to reach the patient's kidney and / or ureter when subjected to force; a first channel extending from a first proximal port at the first handle to a first distal port at the distal end of the first cannula for passing a guidewire; a first imaging module located at the distal end of the first cannula, including a first light source and a first image sensor for capturing a first image of the patient's kidney and / or ureter and a portion of the guidewire protruding distally from the distal end of the first cannula; a first path for outputting the first image; the second disposable part includes: a tube hub; a second cannula extending distally from the distal end of the fluid hub, for retrieving the first cannula from the patient's body and then inserting it into the patient's body to reach the patient's kidney and / or ureter; wherein the second cannula is provided with a second imaging module at its distal end, the second imaging module includes a second light source and a second image sensor, for capturing a second image of the kidney and / or ureter; a second path for outputting the second image; wherein the second cannula can rotate relative to the hub about its long axis, has a flexible distal portion, the flexible distal portion can be bent in a direction away from the long axis, so that the second image can be captured from different angles relative to the kidney and / or ureter; a force transmission mechanism for selectively bending the distal portion of the second cannula after the user inputs information at the proximal portion of the hub; and a sterile package, which encapsulates the first and second disposable parts in a sterile environment, for transporting the kit to the user and storing it until it is needed for PCNL operation.

[0013] According to some embodiments, the kit described in the previous paragraph may further include one or more of the following: (a) the kit may further include a reusable portion, wherein the reusable portion includes an input end, wherein the input end is used to receive a first image from a first disposable portion through a first path, and to receive a second image from a second reusable portion through a second path; an electronic device, wherein the electronic device processes the first image and the second image into a display image; a second handle and a display, wherein the display is mounted on the second handle for selectively displaying the display image; and a control device, wherein the control device is used to control the first and second imaging modules; (b) the input end for receiving the first and second images may include a first connector, wherein the first connector is used to receive the first image; and a second connector, wherein the second connector is separated from the first connector and is used to receive the second image. (c) the reusable portion may include a motor, wherein the motor is operably coupled to the flexible distal portion of the second cannula to bend the flexible portion under the control of the fingers of a user holding the reusable portion; (d) the kit may further include a sterile cover cloth, wherein the sterile cover cloth is used to cover the reusable portion when used in clinical operations; (e) the first path includes a connecting wire, wherein the connecting wire is operably coupled to the first imaging module, extends from the proximal end of the first handle, and is releasably coupled to the reusable portion to transmit the first image to the reusable portion; (f) the first path may include a wireless connector, wherein the wireless connector is located between the first imaging module and the reusable portion, and is used to transmit the first image to the reusable portion; (g) the first handle may be pencil-shaped and may extend along the long axis of the first cannula; and (h) the first cannula may be a straight tube.

[0014] According to some embodiments, a kit for salivary gland endoscopy includes: a hub; a cannula extending distally from a distal end of the hub; a proximal instrument port and a proximal fluid port located at the proximal end of the hub; a distal instrument port and a distal fluid port located at the distal end of the cannula; an internal instrument channel located between the proximal and distal instrument ports; an internal fluid channel located between the proximal and distal fluid ports; and an imaging module located at the distal end of the cannula; an external processor / display and a path from the imaging module to the external processor / display , wherein the processor and display are used to receive images captured using an imaging module, process them into display images and selectively display the display images; wherein the path includes at least one of the following: (i) a connecting line, wherein the connecting line is operably coupled to the imaging module and terminates at a connector of the image processor / display; and (ii) a wireless connector 120, wherein the wireless connector is located between the imaging module and the processor / display; wherein the outer diameter of the cannula is not greater than 2 mm and the inner diameter of the instrument channel is not less than 0.8 mm.

[0015] According to some embodiments, the kit described in the preceding paragraph may further include one or more of the following: (a) a two-dimensional image sensor and a light source located in the imaging module; and (b) an LED light source located in the handle, and one or more optical fibers extending from the LED light source to the distal end of the cannula. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to further illustrate the above and other advantages and features of the subject matter of this patent specification, the accompanying drawings show specific examples of embodiments of this patent specification. It should be understood that these drawings only show illustrative embodiments and therefore should not be considered to limit the scope of this patent specification or the appended claims. The subject matter of this patent specification will be described and explained in more detail by the accompanying drawings, in which:

[0017] Figure 1 is a perspective view of a first disposable portion of an endoscope used in a first stage of a PCNL clinical procedure according to some embodiments.

[0018] Figure 2 is a front view of a distal end of a first disposable portion according to some embodiments.

[0019] Figure 3 Shown is a perspective view of a first disposable portion for use in a first stage of a PCNL procedure and two views of a reusable portion for use in a first stage and a second stage of a PCNL clinical procedure according to some embodiments.

[0020] Figure 4A first disposable portion is shown being percutaneously inserted into a patient's kidney and / or ureter during a first phase of a PCNL clinical procedure according to some embodiments.

[0021] Figure 5 and Figure 4 Similar, but showing a first disposable portion coupled to a reusable portion during a first phase of a PCNL clinical procedure according to some embodiments.

[0022] Figure 6 and Figure 4 Similar, but showing a guidewire inserted into a first disposable channel during a first stage of a PCNL clinical procedure according to some embodiments.

[0023] Figure 7 A second disposable portion is shown assembled with a reusable portion into a handheld endoscope for use in a second phase of a PCNL clinical procedure, according to some embodiments.

[0024] Figure 8 is a side view of a second disposable portion assembled with a reusable portion into a handheld endoscope for use in a second phase of a PCNL clinical procedure according to some embodiments.

[0025] Fig. 9 and Fig.10 is a perspective view of an assembled second disposable portion and a reusable portion fitted into a handheld endoscope for a second stage of a PCNL clinical procedure at different viewing angles according to some embodiments.

[0026] Fig.11 The sterile package according to some embodiments is shown in perspective, wherein the sterile package encloses a first disposable portion and a second disposable portion, and optionally a drape for a reusable portion.

[0027] Fig.12 A reusable portion is shown fully enclosed in a drape according to some embodiments, wherein the drape may be sterile and may remain during a PCNL clinical procedure.

[0028] Fig.13 is a partial perspective view and partial schematic diagram of a kit for salivary gland endoscopy according to some embodiments.

[0029] Fig.14 is a perspective view of a distal portion of a cannula for salivary gland endoscopy according to some embodiments. DETAILED DESCRIPTION

[0030] Examples of preferred embodiments are described in detail below. This patent specification describes multiple embodiments, but the new subject matter described therein is not limited to any one embodiment or combination of embodiments described therein, but rather encompasses many alternatives, improvements, and equivalents. In addition, the following description provides many specific details for in-depth understanding, but some embodiments may be practiced in the absence of some or all of the described details. Moreover, for the sake of clarity, this patent specification does not describe in detail certain technical information known in the relevant art to avoid unnecessary confusion about the new subject matter described therein. It should be clear that the individual features of one or more specific embodiments described in this patent specification may be used in combination with features or other features of other described embodiments. Similar reference numbers and marks in different drawings represent similar components.

[0031] According to the more detailed description below, a sterile kit for PCNL operation includes a first disposable part and a second disposable part provided in a sealed sterile package. In the first stage of the PCNL clinical operation, the user opens the packaging of the first disposable part, uses the sharp end of the first cannula to penetrate the patient's skin, and places the tip of the first cannula to the expected position relative to the patient's kidney or ureter, usually while observing the progress of the first cannula in the patient's body using imaging methods such as ultrasound or fluoroscopy. Still in the first stage of the operation, when the first cannula is in the expected position in the patient's body, the user passes the guide wire through the channel in the first disposable part. Then, the user retrieves the first cannula from the patient's body, while keeping the guide wire in the appropriate position in the patient's body, and inserts the trocar or another branch tube into the working area in the kidney or ureter. Before inserting the trocar, one or more dilators can be used to expand the passage to the kidney. In the second stage of the clinical operation, the user performs clinical operations on the kidney and / or ureter, such as kidney stone removal, using surgical instruments passed through the trocar, and usually inserts a second disposable part assembled with the reusable part into the handheld endoscope through the trocar to observe the working area during or after the surgical operation.

[0032] Figure 1 is a perspective view of the first disposable portion 100 of the endoscope, Figure 21 is a front view of the distal end of the first disposable portion for the first stage of a clinical procedure of minimally invasive percutaneous nephrolithotomy (PCNL) according to some embodiments. The disposable portion 100 includes a first handle 102 having a shape and size that can be held by a user with his or her fingers. In one example, the first handle 102 is slightly thicker than a typical pencil. The first cannula 104 extends distally from the distal end of the first handle 102, has a sharp distal end 106, and is made of a sufficiently hard material (e.g., medical grade stainless steel) to pass through the patient's skin and tissue when subjected to force to reach the kidney and / or ureter. The first disposable portion 100 is used to insert a guide wire 500 so that it passes through the proximal port 110, extends distally through the first channel 108, and protrudes from the distal port 112 when necessary. The first disposable portion 100 is provided with a first imaging module 114 at the distal end of the first cannula 104, wherein the first imaging module includes a first light source 116 and a first two-dimensional image sensor 118 for capturing a first image of the patient's kidney and / or ureter. The first image may include a portion of the guidewire 500 that may protrude from the distal end 106 of the first cannula 104. The first disposable portion 100 further includes a first path operably coupled to the first imaging module 114 and configured to output the first image. In one example, the first path includes a connection line 122 that outputs the first image through a connector 124. In another example, the first path includes a wireless connector 120, such as a WiFi connector, that outputs the first image. The WiFi transmitter 120 may be located in the connector 124 or in the first handle 102. In a preferred embodiment, the working length of the cannula 104 is 10 cm, but other working lengths may be used for different patients or procedures. The channel 108 and ports 110 and 112 may be used for fluids instead of the guidewire 500, or may also be used for the guidewire 500. The first light source 116 may include one or more mini LEDs located at the distal end of the cannula 104 or an LED light source located in the handle 102 and one or more optical fibers extending therefrom to the distal end of the first cannula 104.

[0033] Figure 2 is a front view of the distal end of the first cannula 104 , showing an example of arranging the LED or optical fiber 118 , the image sensor, and the channels 108 (which may be two parallel channels in this example) within the first cannula 104 , according to some embodiments.

[0034] Figure 3Two perspective views of the first disposable portion 100 and the reusable portion 200 at different angles are shown according to some embodiments, wherein the reusable portion is releasably coupled with the first disposable portion 100 to form an assembled endoscope during the first stage of a PCNL clinical procedure. The reusable portion 200 includes a second handle 202, a display 204, and electronic devices 206, and optionally includes a battery 207 that may be fully or partially located in the second handle 202 and / or the display 204, and a connector, such as a socket 208, for mating with the first disposable portion connector 124.

[0035] Figure 4 The use of the disposable portion 100 in the first stage of a PCNL clinical operation is shown, wherein the cannula 104 of the disposable portion 100 is inserted through the skin into the tissue of the patient 402 to reach or enter the patient's kidney 404 and / or ureter 406, for example, to the location of the kidney stone shown in black. This process is usually completed under the guidance of an imaging method such as ultrasound or fluoroscopy. For at least a portion of the insertion, the disposable portion 100 can but need not be assembled into an endoscope with the reusable portion 200. The display 204 can display a first image captured using the first imaging module 114. As an alternative or in addition, the first image can be sent to a different display (not shown) for display via a connecting line of the wireless connector 120.

[0036] Figure 5 The PCNL clinical procedure is shown in at least a portion of the first stage by connecting line 122 (and Figure 3 The disposable portion 100 is coupled to the reusable portion 200 (with a connector 124 and a socket 208 shown in FIG. 1 ). Preferably, at least at the terminal portion of the insertion, the disposable portion 100 is coupled to the reusable portion 200 so as to transmit the first image from the imaging module 114 to the display 204 for display. When the first imaging module 114 is located in the kidney 404 and / or the ureter 406, the user can use the first handle 102 for precise positioning while observing the first image on the display 204 until the distal end 106 of the first cannula 104 reaches the desired position in the kidney 406 and / or the ureter 406.

[0037] Figure 6 A guidewire 500 is shown being passed through port 110 until it reaches or protrudes through distal port 112, which is currently at a desired location in kidney 404 and / or ureter 406. A medical professional typically passes the guidewire 500 until its desired portion protrudes distally from distal port 106 of first cannula 104. Figure 6 Although not shown, the reusable portion 200 may be removed when the guide wire 500 is passed through (e.g. Figure 5104) remains coupled to the disposable portion 100 so that the user can observe a portion of the guidewire 500 protruding from the first cannula 104 as the guidewire 500 passes through, which helps to accurately place the distal end of the guidewire.

[0038] Figure 7 An example of the second stage of a PCNL clinical procedure is shown. After completing the above-mentioned first stage, the user retrieves the disposable portion 100 from the patient 402 via the guidewire 500, leaves the guidewire in place in the patient's body, and in one example, inserts one or more dilators to enlarge the path to the kidney, and then places a trocar 702 or another branch tube into the patient's body via the guidewire 500. The user performs a clinical procedure of treating the kidney 404 and / or ureter 406 through the trocar or tube 702, using an instrument that passes through the trocar or tube or through the channel in the second disposable portion. In one example, the outer diameter of the second cannula 704 is 4.5 mm or less, and the channel 705 ( Fig. 9 ) has an inner diameter of 2 mm. Other sizes may also be suitable.

[0039] During and after treatment in the workspace during the second phase of the clinical procedure, the user can use the second imaging module 714 at the distal end of the second cannula 706 to observe the kidneys and / or ureters or other nearby parts. The second imaging module is used to capture and transmit a second image that can be displayed at the display 204. When the user assembles the endoscope for the second phase of PCNL, the second disposable part 700 is releasably coupled to the single user part 200 to form a handheld endoscope. The second disposable part includes a second cannula 704 and a tube hub 706. The second cannula 704 is provided with a second imaging module 714 at its distal end, which is similar to the first imaging module 114 and includes a light source 716 and a two-dimensional image sensor 718.

[0040] Figure 8 An example of a second disposable portion 700 coupled to a reusable portion 200 is shown in greater detail. The details of portions 700 and 200 may be similar to the details of portions 104 and 102 described in prior U.S. patent application Ser. No. 17 / 370,575 filed on July 8, 2021 (published as US2021 / 0338052 A1), respectively, but with the addition of a socket 208 ( Figure 3 ). The prior patent application is incorporated by reference in this patent specification as a part of this patent specification. Some of the reference numbers are used in this patent specification. For a more detailed description of the endoscope shown, see the prior application.

[0041] like Figure 8As shown, as described in detail in prior application No. 17 / 370,575, the second disposable portion 700 includes a hub 706 and a second cannula 704 (identified by reference numbers 120 and 170 in application No. 17 / 370,575). As shown and described in application No. 17 / 370,575, the second disposable portion 700 has a flexible distal portion 210 that bends away from the long axis of the cannula 704. The bending is controlled by a finger control device 720 in this example, and the disposable portion 704 is coupled to the reusable portion 200 to form an endoscope as shown and described in application No. 17 / 370,575. The imaging module 714 is operably coupled to the display 204, and the finger-operated control device 720 is operably coupled (e.g., via a connecting wire) to the flexible distal portion described in the above-mentioned prior application.

[0042] Fig. 9 and Fig.10 Another example of a second disposable portion 700 is shown, wherein the second disposable portion is operably coupled to the reusable portion 200 to form an endoscope for use in a second phase of a PCNL clinical procedure. Fig. 9 and Fig.10 Related to prior U.S. Patent Application No. 18 / 083,209 filed on December 16, 2022 Figure 2 B and Figure 2 C, but with the addition of a socket 208, showing multiple components in other figures of the prior application, and adding multiple reference numbers used in this patent specification. As described in prior application No. 18 / 083,209 (which prior application becomes a part of this patent specification through reference in this patent specification), the reusable portion 200 includes a motor 111 and an electronic device 119, which is used to process the second image into a display image that can be displayed on the display 204 and control the bending of the flexible distal portion of the second cannula 704. The electronic device 119 can be located in the handle 202 and / or in the display 204. A power source such as a battery 109 can power the electrical components. The motor 111 is operably coupled to the flexible distal portion of the second cannula 704, and the flexible portion is bent to a selected angle in a selected direction when the motor operation is manually controlled by a finger-operated button 144. In this way, the working area can be observed from different angles, and the distal end of the second cannula can be introduced into the ureter and other parts as needed. As Fig. 9 and Fig.10 As shown, as described in prior application No. 18 / 083,209, the reusable portion 200 has a shaft 113 that is rotated by a motor 111 to drive a gear 721 in a hub 706 to selectively bend the distal portion of the cannula 704 (206). Fig. 9 and Fig.10As shown, as described in the above-mentioned prior application, the proximal ports 118, 120 can be used for surgical instruments and / or fluid input and output, and the distal end of the second cannula 700 is provided with one or more distal ports. Fig. 9 and Fig.10 As shown, as described in the above-mentioned prior application, the second cannula 700 can rotate about its long axis relative to the reusable part 200 (preferably, relative to the tube hub 706). Accordingly, by bending the distal flexible portion of the second cannula 704 and rotating the cannula 704, the user can observe the working area and adjacent parts from different perspectives.

[0043] Fig.11 A sterile package 1102 is schematically shown, wherein the sterile package encloses the first disposable portion 100 and the second disposable portion 700 in a sterile environment for transporting the kit to a user and storing it in a sterile environment until needed for use in a PCNL clinical procedure.

[0044] Fig.12 The reusable portion 200 is shown fully enclosed in a cover cloth 1202, which may be sterile and may remain on the portion 200 when the portion 200 is coupled to the disposable portion 100 during a first phase of clinical operation at PCNL and / or when the disposable portion 700 is coupled to the reusable portion 200 during a second phase of clinical operation. In some but not all examples, the cover cloth 1202 may be enclosed in a sterile package 1102 and stored in a sterile environment.

[0045] Fig.13 13 is a partial perspective view and a partial schematic view of a kit 1300 for salivary gland endoscopy according to some embodiments. The kit includes a hub that can be grasped by a user's hand, and a cannula 1304 extending distally from a distal end of the hub. A proximal instrument port 1306 and a proximal fluid port 1308 are located at the proximal end of the hub, and a distal instrument port 1315 and a distal fluid port 1313 are located at the distal end of the cannula. An internal instrument channel 1315 between the proximal and distal instrument ports and an internal fluid channel between the proximal and distal fluid ports extend through the handle 1302 and the cannula 1304. An imaging module 1312 is located at the distal end of the cannula 1304. The external processor / display is operably coupled to the imaging module 1312 via a path that may be (i) a cable 122 terminating at a connector 1318 that releasably mates with a connector 1319 at the processor / display; and / or (ii) a wireless connection 120 that may include a transceiver 1322 (located in the handle 1318) or 1324 (located in the connector 1318).

[0046] As shown, the distal end of the cannula 1304 is provided with a distal instrument port 1315 and a distal fluid port 1315, and a two-dimensional image sensor 1402 that together with a light source forms an imaging module 1312. The light source may include one or more mini LEDs located at the distal end of the cannula 1304, or one or more optical fibers operably coupled to the LED light source 1326 in the handle 1302. In a non-limiting example, the outer diameter of the cannula 1302 is 1.55 mm, the inner diameter of the instrument channel 1315 is 0.8 mm, the inner diameter of the fluid channel 1313 is 0.3 mm, the diameter of each optical fiber 1404 is 0.25 mm, and the image sensor 1402 is a square with each side being 0.64 mm. Preferably, by Fig.11 A similar sterile package, but with a single compartment, is shown to provide the user with the kit 300. The sterile package does not contain a processor / display.

[0047] In operation, the user removes the kit 1300 from the sterile packaging and establishes communication between the imaging module 1312 and the processor / display through the path. Control devices for operating the imaging module 1312 (e.g., capturing still or video images) may be provided on the handle 1302 and / or other locations (e.g., at the processor / display or in the platform switch). Guided by the image captured using the imaging module 1312 and displayed at the processor / display, the user pushes the distal end of the cannula 1304 in the salivary duct to the desired position in the duct or at the salivary gland. The user can flush tissue or deliver drugs by connecting a fluid source to the proximal fluid port 1308, and can move surgical tools such as ablation needles or grasping forceps in and out of the distal instrument port 1315 through the proximal instrument port 1306 to perform clinical operations while observing the work area at the processor / display 1304.

[0048] The above description is provided in more detail for the sake of clarity, but it is obvious that certain changes and modifications can be made without departing from the principles thereof. It should be noted that the processes and devices described in this patent specification can be implemented in many alternative ways. Therefore, these embodiments should be regarded as illustrative embodiments rather than restrictive embodiments, and the research subject described in this patent specification is not limited to the details described therein, and can be modified within the scope and equivalent scheme of the attached claims.

Claims

1. A kit for clinical operation of minimally invasive percutaneous nephrolithotomy, characterized in that: include: A first disposable portion (100) includes a first handle (102); a first cannula (104) extending distally from the first handle and having a sharp distal end (106); a first channel (108) extending from a first proximal port (110) in the handle to a first distal port (112) in the cannula for inserting a guide wire (500) through and extending distally out of the first channel; and a first imaging module (114) located at the distal end of the first cannula and including a first light source (116) and a first image sensor (118); A second disposable portion (700) comprising a hub (706); a second cannula (704) extending distally from the hub; and a second imaging module (714), located at the distal end of the second cannula, comprising a second light source (716) and a second image sensor (718); wherein the first cannula is used to be inserted into a patient's kidney (404) and / or ureter (406), and the first imaging module is used to capture a first image of a patient's part during a first stage of a clinical operation, wherein the first image selectively includes any guidewire portion extending out of a distal end of the first channel; wherein the second cannula is used to be inserted into the kidney and / or ureter of the patient in the second stage of the clinical operation after the first cannula is retrieved from the patient's body, and the second imaging module is used to capture a second image of the patient's part in the second stage of the clinical operation; A reusable portion (200) comprising a second handle (202), a display (204) carried thereby, and image processing electronics (206); wherein the reusable portion is used to couple with the first disposable portion during a first stage of clinical operation to receive, process and display a first image, and to couple with the second disposable portion during a second stage of clinical operation to receive, process and display a second image; The kit further includes a first path for transmitting a first image from the first imaging module to the reusable portion during a first phase of clinical operation; and a second path for transmitting a second image from the second imaging module to the reusable portion during a second phase of clinical operation.

2. The kit according to claim 1, wherein: Further comprising a sterile package (1102), wherein the sterile package respectively encapsulates the first disposable portion (100) and the second disposable portion (700), for transporting the kit to the user in a sterile form and storing it until needed for a minimally invasive percutaneous nephrolithotomy operation.

3. The kit according to claim 1, wherein: The second cannula includes a flexible distal portion (210, 214), wherein the flexible distal portion can be bent in a direction away from the long axis of the second cannula, and the reusable portion includes a motor (111), wherein the motor is operably coupled to the flexible portion to bend the flexible portion to a selected angle in a selected direction under the control of the user over the motor.

4. The kit according to claim 3, wherein: The reusable part has a side opening, and its shaft (113) extends transversely along the long axis and can be rotated by a motor. The tube hub includes a gear (721) that cooperates with the shaft in the second stage of clinical operation.

5. The kit according to claim 1, wherein: The hub includes a finger control device (720), wherein the finger control device is operably coupled to the flexible portion for bending the flexible portion to a selected angle in a selected direction upon application of a finger force to the finger control device.

6. The kit according to claim 1, wherein: The first disposable part can be retrieved from the patient's body through the guide wire after the first stage of the clinical operation, leaving the guide wire in the patient's body, and further includes a trocar (702), wherein the trocar is used to be inserted into the patient's body through the guide wire to reach the patient's kidney, so that surgical instruments can be inserted into the kidney and / or ureter through the trocar.

7. The kit according to claim 1, wherein: The first path includes a connection line (122), wherein the connection line is operably coupled to the first imaging module, extends from the first handle, and terminates at a connector (124), and the reusable portion includes a mating connector, wherein the mating connector is used to electrically contact the first connector to transmit the first image to the reusable portion.

8. The kit of claim 1, wherein: The first path includes a wireless connection (120), wherein the wireless connection is located between the first imaging module and the reusable portion, and is used to transmit a first image to the reusable portion during a first stage of clinical operation.

9. The kit of claim 1, wherein: The second path includes an electrical connector in the tube hub and an electrical connector in the reusable portion, wherein the electrical connectors operably cooperate with each other during the second phase of clinical operation to supply power from the reusable portion to the second imaging module and transmit the second image from the second imaging module to the reusable portion during the second phase of clinical operation.

10. The kit of claim 1, wherein: The first handle is of a size suitable for hand-holding.

11. The kit according to claim 10, wherein: The first cannula is a straight tube.

12. A sterile kit for minimally invasive percutaneous nephrolithotomy, comprising a first disposable portion (100) and a second disposable portion (700) for performing a single percutaneous nephrolithotomy clinical operation on a patient (402), wherein: The first disposable portion (100) comprises: a first handle (102); A first cannula (104) extends distally from the distal end of the first handle, has a sharp distal end, and is made of a sufficiently hard material to penetrate the patient's skin and soft tissue when subjected to force to reach the patient's kidney (404) and / or ureter (406); a first channel (108) extending from a first proximal port (110) at the first handle to a first distal port (112) at the distal end of the first cannula for passing a guide wire (500); A first imaging module (114), located at the distal end of the first cannula, comprises a first light source (116) and a first image sensor (118), and is used to capture a first image of the patient's kidney and / or ureter and a portion of the guidewire protruding distally from the distal end of the first cannula; A first path for outputting a first image; The second disposable portion (700) comprises: a tube hub (706); a second cannula (704) extending distally from the distal end of the fluid hub, and used to retrieve the first cannula from the patient's body and then insert it into the patient's body to reach the patient's kidney and / or ureter; The second cannula is provided with a second imaging module (714) at its distal end, and the second imaging module includes a second light source (716) and a second image sensor (718) for capturing a second image of the kidney and / or ureter; a second path for outputting a second image; The second cannula is rotatable about its long axis relative to the tube hub and has a flexible distal portion (214), which can be bent in a direction away from the long axis, so that a second image can be taken from different angles relative to the kidney and / or ureter; a force transfer mechanism for selectively bending the distal portion of the second cannula upon user input at the proximal portion of the hub; and A sterile package (1102) encapsulates the first and second disposable parts in a sterile environment for transporting the kit to a user and storing it until needed for a minimally invasive percutaneous nephrolithotomy procedure.

13. The sterile kit according to claim 12, wherein: Further comprising a reusable portion (200), wherein the reusable portion comprises an input end, wherein the input end is used to receive a first image from a first disposable portion via a first path, and to receive a second image from a second reusable portion via a second path; an electronic device (206, 119), wherein the electronic device processes the first image and the second image into a display image; a second handle (202) and a display (204), wherein the display is mounted on the second handle for selectively displaying the display image; and a control device (720, 144), wherein the control device is used to control the first and second imaging modules.

14. The sterile kit according to claim 13, wherein: The input end for receiving the first and second images includes a first connector, wherein the first connector is used to receive the first image; and a second connector (121), wherein the second connector is separated from the first connector and is used to receive the second image.

15. The sterile kit according to claim 13, wherein: The reusable portion includes a motor (111), wherein the motor is operably coupled to the flexible distal portion of the second cannula to cause the flexible portion to bend under the control of a finger of a user holding the reusable portion.

16. The sterile kit according to claim 13, wherein: Further included is a sterile cover cloth (1204), wherein the sterile cover cloth is used to cover the reusable portion when used in clinical operations.

17. The sterile kit according to claim 12, wherein: The first path includes a connection line (122), wherein the connection line is operably coupled to the first imaging module, extends from the proximal end of the first handle, and is releasably coupled to the reusable portion to transmit the first image to the reusable portion.

18. The sterile kit of claim 12, wherein: The first path includes a wireless connection (120), wherein the wireless connection is located between the first imaging module and the reusable portion for transmitting the first image to the reusable portion.

19. The sterile kit of claim 12, wherein: The first handle (102) can be grasped by a user's fingers.

20. The sterile kit of claim 12, wherein: The first cannula (104) is a straight tube.

21. A single-use kit for salivary gland endoscopy, comprising: a hub; a cannula (1304) extending distally from the distal end of the hub; a proximal instrument port (1306) and a proximal fluid port (1308) located at the proximal end of the hub; a distal instrument port (1315) and a distal fluid port (1313) located at the distal end of the cannula; an internal instrument channel located between the proximal and distal instrument ports; an internal fluid channel located between the proximal and distal fluid ports; and an imaging module (1312) located at the distal end of the cannula; an external processor / display and a path from the imaging module to the external processor / display, wherein the processor and display are used to receive images captured using the imaging module, process them into display images and selectively display the display images; wherein the path includes at least one of: (i) a connection line (122), wherein the connection line is operably coupled to the imaging module and terminates at a connector (1318) and a connector (1319) of the image processor / display; and (ii) a wireless connector (120), wherein the wireless connector is located between the imaging module and the processor / display; Wherein, the outer diameter of the cannula is not greater than 2 mm, and the inner diameter of the instrument channel is not less than 0.8 mm.

22. The disposable kit for salivary gland endoscopy according to claim 21, wherein: The imaging module includes a two-dimensional image sensor (1402) and a light source.

23. The disposable kit for salivary gland endoscopy according to claim 22, wherein: The light source includes an LED light source (1322) located in the handle, and one or more optical fibers (1404) extending from the LED light source to the distal end of the cannula.

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