Patent Application
20230380677
This patent specification generally relates to portable, hand-held endoscopes that are entirely or partly single-use.
Percutaneous nephrolithotomy (PCNL) is a medical procedure to remove stones or perform other surgery on a patient's kidney and/or ureter. In some examples, a retrograde pyelogram is done to locate the stone. Contrast is introduced slowly under fluoroscopy monitoring to observe a sequence of calyces being filled, to help identify the position of posterior calyx. Then, in a first stage of the procedure a percutaneous nephrolithotomy (PCN) needle is passed through the skin and soft tissue into the pelvis of the kidney. The position of the needle is confirmed with an imaging modality such as fluoroscopy or ultrasound. A guide wire is passed through the needle into the pelvis. The needle is then withdrawn, with the guide wire remaining in the pelvis. One or more dilators are passed over the guide wire and then a working sheath is introduced. A nephroscope is then passed inside and stones are taken out, possibly after first being crushed, or another medical procedure is performed on the kidney or ureter. The nephroscope is an optical instrument which allows one to inspect the renal cavitary system and to perform different therapeutic procedures under direct visual control. It contains the optical system for observing the working area and a working channel located in the nephroscope to enable insertion of a lithothripter or different working elements (stone forceps, extraction probe, etc.). The same axial channel also enables irrigation fluid flow. The fluid returns through space between the nephroscope and its sheath. The surgery can take 3-4 hours. A conventional nephroscope is not single-use, which requires thorough decontamination between patients and shortens the instrument's life. Known nephroscopes use an optical path for viewing the working area, which requires the surgeon to view the working area through an eyepiece attached to the nephoscope and thus limits the surgeon's body and head positions as well as the viewing angle.
Sialendoscopy is a minimally invasive procedure to diagnose and treat salivary gland disorders including stones, strictures, chronic inflammation and other problems affecting the major salivary glands. Reusable instruments for have been offered by Karl Storz of Tuttlingen, Germany and other companies and can be flexible, semiflexible, or rigid, and can be only for viewing and diagnosis or can include working channels for surgical instruments. Such known instruments are not single-use and therefore need to be thoroughly decontaminated between patients, which shortens their life, requires the expense of additional personnel and equipment, and still cannot completely eliminate the risk of cross-contamination. Known instruments are discussed in Iro H, Zenk J, Koch M, and Bozzato A, The Erlangen Salivary Gland Project, Part 1, Endo Press GmbH, Erlangen, Germany, 2005 (print 2007), ISBN 978-3-89756-149-6, which is hereby incorporated by reference.
The subject matter described or claimed in this patent specification is not limited to embodiments that solve any specific disadvantages or that operate only in environments such as those described above. Rather, the above background is only provided to illustrate one exemplary technology area where some embodiments described herein may be practiced.
As described in the initially presented claims but subject to amendments thereof during prosecuting this patent application, according to some embodiments a kit for PCNL medical procedures contains two different single-use portions that are utilized in respective different stages of the medical procedure. In each stage a reusable portion is coupled with the single-use portion to enable viewing an electronic image of the work area. Contamination risks are greatly reduced, the expense of time and personnel and equipment for decontaminating a reusable nephroscope are eliminated, and viewing the electronic image enables greater freedom of movement of the surgeon and reduces fatigue.
In addition, after the needle is inserted under guidance of fluoroscopy or ultrasound, it is very valuable to have optical vision at the tip of the needle to visually confirm the targeted location and embodiments disclosed herein accomplish this without an additional insertion of a nephoscope or a tool for inserting a guidewire.
According to some embodiments, a kit for performing minimally invasive percutaneous nephrolithotomy (PCNL) medical procedure comprises: a first single-use portion comprising a first handle, a first cannula that extends distally from the first handle and has a sharpened distal end, a first channel that extends from a first proximal port in the handle to a first distal port in the cannula and is configured for insertion of guidewire through and distally out of the first channel, and a first imaging module that is at a distal end of the first cannula and comprises a first light source and a first image sensor; a second single-use portion comprising a hub, a second cannula that extends distally from the hub, and a second imaging module that is a distal end of the second cannula and comprises a second light source and a second image sensor; wherein the first cannula is configured for insertion to or inoto a patient's kidney and/or ureter and the first imaging module is configured to take first images thereof that selectively include any guidewire portion extending out of the distal end of the first channel during a first stage of the medical procedure; wherein the second cannula is configured for insertion to or into the patient's kidney and/or ureter during a second stage of the medical procedure, after the first canula has been withdrawn from the patient, and the second imaging module is configured to take second images thereof during a second stage of the medical procedure; a reusable portion that comprises a second handle, a display carried thereby and image-processing electronics; wherein the reusable portion is configured to couple with the first single-use portion during said first stage of the medical procedure to thereby receive said first images and process and display them, and to couple with said second single-use portion during said second stage of the medical procedure to thereby receive said second images and process and display them; wherein said kit further includes a first pathway configured to convey said first images from the first imaging module to the reusable portion during the first stage of the medical procedure and a second pathway configured to convey the second images from the second imaging module to the reusable portion during in second stage of the medical procedure.
According to some embodiments, the kit can further comprise one or more of the following: (a) a sterile package enclosing said first and second single-use portions for shipping to a user and for storing until needed for a PCNL procedure; (b) the second cannula can include a flexible distal portion configured to bend away from a long axis and the second cannula and the reusable portion can include an electric motor operatively coupled with said flexible portion to bend the flexible portion in a selected direction and through a selected angle under manual control over the motor operation; (c) the reusable portion can have a side opening with a shaft extending transversely to the long axis and configured to be rotated by said motor, and said hub can include a gear mating with said shaft during said second stage of the medical procedure; (d) the hub can include a finger control operatively coupled with said flexible portion and configured to bend the flexible portion in a selected direction and through a selected angle in response to force exerted on the finger control; (e) the first single-use portion can be configured to be withdrawn over the guidewire after the first stage of the medical procedure, leaving the guidewire in the patient, and further including a trocar configured to the inserted in the patient to the patient's kidney over the guidewire, enabling surgical instruments to be inserted through the trocar to the kidney and/or ureter; (f) said first pathway can comprise a cable operatively coupled with said first imaging module, extending from the proximal end of the first handle and terminating in a first connector and the reusable portion can comprise a matching connector configured to make electrical contact with the first connector and to transmit power from the reusable portion to the first single-use portion and to convey said first images to the reusable portion; (g) said first pathway can comprise a wireless connection between said first imaging module and said reusable portion configured to convey said first images to the reusable portion during the first stage of the medical procedure; (h) the second pathway can comprise electrical connectors in the hub and in the reusable portion operatively mating with each other during said second stage of the medical procedure to thereby supply power from the reusable portion to the second imaging module and to convey the second images from the second imaging module to the reusable portion during the second stage of the medical procedure; (i) the first handle can be pencil-shaped and sized to be hand-held and can extend along a long axis of said first cannula; and (j) said first cannula can be straight.
According to some embodiments, a sterile kit for performing minimally invasive percutaneous nephrolithotomy (PCNL) comprises a first single-use portion and a second single-use portion configured for use in a single PCNL medical procedure on a patient, wherein: the first single-use portion comprises: a first handle; a first cannula that extends distally from a distal end of the first handle, has a sharp distal end, and is made of a material that is sufficiently stiff to be forced through the patient's skin and soft tissue to reach a kidney and/or ureter of the patient; a first channel that extends from a first proximal port at the first handle to a first distal port at the distal end of the first cannula and configured for passage of a guidewire; a first imaging module at the distal end of the first cannula comprising a first light source and a first image sensor configured to take first images 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 pathway configured to output the first images; the second single-use portion comprises: a hub; a second cannula that extends distally from a distal end of the fluid hub and is configured for insertion in the patient to reach the kidney and/or the ureter thereof after the first cannula has been withdrawn from the patient; wherein said second cannula has a second imaging module at a distal end thereof comprising a second light source and a second image sensor configured to take second images of the kidney and/or ureter; a second pathway configured to output the second images; wherein said second cannula is configured to rotate about a long axis thereof relative to said hub and has a flexible distal portion configured to bend away from said long axis to thereby enable taking said second images from different angles relative to the kidney and/or ureter; a force transfer mechanism configured to selectively bend said distal portion of the second cannula in response to user inputs at a proximal portion of the hub; and a sterile package that encloses the first and second single-use portions in a sterile environment for shipping the kit to a user and for storing the kit until needed for a PCNL procedure.
According to some embodiments, the kit described in the immediately preceding paragraph can further include one or more of the following: (a) the kit can further comprise a reusable portion, wherein the reusable portion comprises inputs for receiving said first images from the first single-use portion over said first pathway and for receiving said second images from said second reusable portion over the second pathway, electronics configured to process said first and second images into display images, a second handle and a display mounted thereon and configured to selectively display the display images, and controls configured to control said first and second imaging modules; (b) said inputs for receiving said first and second images can comprise a first connector for receiving the first images and a second connector, spaced from the first connector, for receiving the second images; (c) the reusable portion can include an electric motor operatively coupled with said flexible distal portion of the second cannula to bend said flexible portion under finger control by a user holding said reusable portion; (d) the kit can further include a sterile drape configured to cover said reusable portion while used in said medical procedure; (e) said first pathway can comprise a cable operatively coupled with said first imaging module, extending from the proximal end of the first handle, and releasably coupled to said reusable portion to thereby convey said first images to the reusable portion; (f) said first pathway can comprise a wireless connection between said first imaging module and said reusable portion configured to convey said first images to the reusable portion; (g) the first handle can be pencil-shaped and can extend along a long axis of said first cannula; and (h) said first cannula can be straight.
According to some embodiments, a kit for use in sialendoscopy comprises; a hub, a cannula extending distally from a distal end of the hub, a proximal device port and a proximal fluid port at a proximal end of the hub, a device distal port and a fluid distal port at a distal end of the cannula, an internal device channel between the device proximal and distal ports, an internal fluid channel between the proximal and distal fluid ports, and an imaging module at the distal end of the cannula; an external processor/display and a pathway thereto from the imaging module, said processor and display configured to receive images taken with said imaging module, process them into display images and selectively display the display images; wherein said pathway comprises at least one of (i) a cable operatively coupled with said imaging module and terminating in a connector and a connector at the image processor/display, and (ii) a wireless connection 1320 between the imaging module and the processor/display; wherein the cannula has an outside diameter no greater than 2 mm and the device channel has an inside diameter of no less than 0.8 mm.
According to some embodiments, the kit described in the immediately preceding paragraph can further include one or more of the following: (a) a two-dimensional image sensor and a light source in the imaging module; and (b) an LED source in the handle and one or more light fibers extending from the LED source to the distal end of the cannula.
To further clarify the above and other advantages and features of the subject matter of this patent specification, specific examples of embodiments thereof are illustrated in the appended drawings. It should be appreciated that these drawings depict only illustrative embodiments and are therefore not to be considered limiting of the scope of this patent specification or the appended claims. The subject matter hereof will be described and explained with additional specificity and detail through the accompanying drawings in which:
A detailed description of examples of preferred embodiments is provided below. While several embodiments are described, the new subject matter described in this patent specification is not limited to any one embodiment or combination of embodiments described herein, but instead encompasses numerous alternatives, modifications, and equivalents. In addition, while numerous specific details are set forth in the following description to provide a thorough understanding, some embodiments can be practiced without some or all these details. Moreover, for the purpose of clarity, certain technical material that is known in the related art has not been described in detail to avoid unnecessarily obscuring the new subject matter described herein. It should be clear that individual features of one or several of the specific embodiments described herein can be used in combination with features of other described embodiments or with other features. Like reference numbers and designations in the various drawings indicate like elements.
As described in more detail below, a sterile kit for a PCNL procedure comprises a first single-use portion and a second single-use portion, supplied in a sealed, sterile package. In a first stage of a PCNL medical procedure, the user unpacks the first single-use portion, penetrates a patient's skin with a sharp end of a first cannula and positions the tip of the first cannula at a desired location relative to the patient's kidney or ureter, typically while observing the first cannula's progress in the patient's body with an imaging modality such as ultrasound or fluoroscopy. Still in the first stage of the procedure, when the first cannula is at a desired position in the patient, the user threads a guidewire through a channel in the first single-use portion. The user then withdraws the first cannula from the patient, while keeping the guidewire in place in the patient, and inserts a trocar or another tube to a working area in the kidney or ureter. Before inserting the trocar, the passageway to the kidney may be enlarged with one or more dilators. In a second stage of the medical procedure, the user performs a medical procedure on the kidney and/or ureter, such as kidney stone extraction, using surgical instruments passed through the trocar and inserts, typically through the trocar, a second single-use portion assembled with a reusable portion into a hand-held endoscope, to view the work area during or after the surgical procedure.
During and after treating the work area in the second stage of the medical procedure, the user can observe the kidney and/or ureter or other nearby anatomy with a second imaging module 714 at a distal end of second cannula 706, which is configured to take and convey second images for display at display 204. For use in this second stage of PCNL, the user assembles an endoscope comprising a second single-use portion 700 that comprises a second cannula 704 and a hub 706 releasably coupled with single user portion 200 to form a hand-held endoscope. Second cannula 704 has at its distal end a second imaging module 714 that can be like first imaging module 114 and comprise a light source 716 and two-dimensional image sensor 718.
As seen in
As shown, the distal end of cannula 1304 houses device distal port 1313 and fluid distal port 1315, and two-dimensional image sensor 1402 that together with light source 1404 forms imaging module 1312. Light source 1404 can comprise one or more mini-LEDSs at the distal end of cannula 1304 or one or more light fibers operatively coupled with an LED source 1326 in handle 1302. In a non-limiting example, the outside diameter of cannula 1302 is 1.55 mm, device channel 1315 has an inside diameter 0.8 mm, fluid channel 1313 has inside diameter 0.3 mm, each light fiber 1404 had diameter 0.25 mm, and image sensor 1402 is a square 0.64 mm per side. Kit 300 preferably is supplied to a user in a sterile package like that shown in
In operation, the user removes kit 1300 from the sterile package and enables pathway 1316 or 1320 to establish communication between image module 1312 and processor/display 1314. Controls over operations of imaging module 1312, such as for taking still or video images, can be provided on handle 1302 and/or at other locations such as at processor/display 1314 or in floor switches. Guided by images taken with imaging module 1312 and displayed at processor/display 1314, the user advances the distal end of cannula 1304 in a salivary duct to a desired location in the duct or at a salivary gland. The user can connect a fluid source to proximal fluid port 1308 to flush tissue or deliver medication, and can pass surgical implements such as ablation needles or graspers through proximal device port 1306 to and out of distal device port 1315 to perform medical procedures while observing the work area at processor/display 1304.
Although the foregoing has been described in some detail for purposes of clarity, it will be apparent that certain changes and modifications may be made without departing from the principles thereof. It should be noted that there are many alternative ways of implementing both 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, which may be modified within the scope and equivalents of the appended claims.
This application claims the benefit of provisional applications Ser. Nos. 63/522,395 filed Jun. 21, 2023 and 63/521,704 filed Jun. 19, 2023, and is a continuation in-part of each of parent applications: (a) Ser. No. 17/720,143 filed Apr. 13, 2022, (b) Ser. No. 17/521,397 filed Nov. 8, 2021, and (c) Ser. No. 17/370,575 filed Jul. 8, 2021. This application incorporates by reference the entirety of the foregoing patent applications and claims the benefit of the filing date of each as well as of the applications that they incorporate by reference, directly or indirectly and the benefit of which they claim, including U.S. provisional applications, U.S. non-provisional applications, and international applications.
| Number | Date | Country | |
|---|---|---|---|
| 63522395 | Jun 2023 | US | |
| 63521704 | Jun 2023 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 17720143 | Apr 2022 | US |
| Child | 18233282 | US | |
| Parent | 17521397 | Nov 2021 | US |
| Child | 17720143 | US | |
| Parent | 17370575 | Jul 2021 | US |
| Child | 17521397 | US |
