MINIMALLY INVASIVE ENDOSCOPE
An endoscope in which a reusable portion is inserted nearly all the way into a hollow, pistol-grip handle of a single-use portion and the protruding part of the reusable portion and an adjacent part of the handle are covered with a flexible and resilient cap. The same cap covers the open end of the handle when the single-use portion is shipped from a manufacturing site. At a user's facility, a health professional tears the pouch, removes the cap from the handle, inserts the reusable portion, and covers the distal end of the reusable portion and an adjacent part of the handle with the same cap. Typically, a remote display connects to the endoscope wirelessly or through a cable, with a connector that fits through a hole in the cap configured to keep fluids from entering around the connector. The wireless transmission preferably uses a proprietary protocol to preserve medical data confidentiality.
This application is a continuation-in-part of parent U.S. patent application Ser. No. 17/521,397 filed Nov. 8, 2021, and claims priority to U.S. Provisional Patent Applications Nos. 63/176,307, filed Apr. 18, 2021; 63/285,061, filed Dec. 1, 2021; 63/295,913, filed Jan. 2, 2022; 63/299,829, filed Jan. 14, 2022; No. 63/302,563, filed Jan. 25, 2022; 63/303,690, filed Jan. 27, 2022; 63/310,336, filed Feb. 15, 2022; and 63/299,960, filed Jan. 25, 2022. Said parent application in turn claims priority to and incorporates by reference each of the following U.S. Provisional Patent Applications: 63/112,739 filed Nov. 12, 2020; 63/113,960 filed Nov. 15, 2020; 63/118,617 filed Nov. 25, 2020; 63/128,105 filed Dec. 20, 2020; and 63/138,528 filed Jan. 18, 2021. This application incorporates by reference each of the foregoing patent applications and claims priority thereto.
FIELDThis patent specification relates to endoscopes and more specifically to endoscopes for medical procedures that have lower manufacturing cost and can be fully or partly disposable and avoid or significantly reduce contamination risk.
BACKGROUNDConventional endoscopy, or direct vision used to examine the interior of a hollow organ or cavity of the body, uses a complex lens system for transmitting the image for the distal tip of the endoscope to a viewer. The lens system is typically an objective lens plus a relay lens system in the case of rigid endoscopes or a bundle of optic fibers in the case of flexible endoscopes. In the case of both rigid and flexible conventional endoscopes, the lens or fiber optic system is relatively expensive and is intended to be re-used many times. Therefore, stringent decontamination and disinfection procedures need to be carried out after each use.
Disposable endoscopy is a more recent category of endoscopic instruments. In some cases, the manufacture of endoscopes can be made sufficiently inexpensive to be used on a single patient only. Disposable or single-use endoscopy lessens the risk of cross-contamination and hospital acquired diseases, make it possible to perform procedures in doctors' offices as well as in clinics and hospitals, and reduce the overall cost of medical procedures as they avoid expenses associated with sterilizing and maintaining traditional endoscopes and personnel needed for such maintenance.
Examples of endoscopes, including partly of fully disposable endoscopes, are discussed in the following patents and patent applications, each of which is hereby incorporated by reference: PCT/US 2016/18670 filed Feb. 19, 2016; U.S. Pat. No. 8,702,594, PCT/US2017/053171 filed Sep. 25, 2017; U.S. patent application Ser. No. 16/363,209 filed Sep. 25, 2017 and published as 2019/0216325 A1 on Jul. 18, 2019; PCT/US2019/036060 filed Jun. 7, 2019; U.S. patent application Ser. No. 16/972,989 filed Jun. 7, 2019 and published as 2021/0251789 A1 on Aug. 19, 2021; U.S. patent application Ser. No. 17/362,043 filed Jun. 29, 2021; PCT/US21/50095 filed Sep. 13, 2021; U.S. patent application Ser. No. 17/473,587 filed Sep. 13, 2021; U.S. Patent No. 8,702,594; PCT/US16/65396 filed Dec. 7, 2016; U.S. Pat. No. 9,649,014; PCT/US2018/014880, filed Jan. 23, 2018; U.S. Pat. Nos. 10,874,287; 9,895,048; 10,524,636; 10,426,320; 10,278,563; 10,292,571; U.S. patent application Ser. No. 16/407,028 filed May 8, 2019 and published as 20190261836 on Aug. 29, 2019; PCT/US2020/038349 filed Jun. 18, 2020; PCT/US2020/046018 filed Aug. 12, 2020; U.S. Pat. Nos. 10,869,592; 11,013,396; 11,071,442; U.S. patent application Ser. No. 17,122,282 filed Dec. 15, 2020 and published as 20210093169 on Apr. 1, 2021; U.S. patent application Ser. No. 17/145,466 filed Jan. 11, 2021 and published as 20210137352 on May 13, 2021; U.S. patent application Ser. No. 17/349,674 filed Jun. 16, 2020 and published as 20210307591 on Oct. 7, 2021; and U.S. patent application Ser. No. 17/370,575 filed Jul. 8, 2021.
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.
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:
According to some embodiments, an endoscope comprises a single-use portion comprising: an elongated housing extending along a cannula axis; a fluid hub extending distally along the cannula axis from the housing; a cannula that extends distally from the fluid hub along the cannula axis and has an imaging module at a distal end; a hollow, funnel-shaped, pistol-grip handle that extends from the housing along a handle axis that is transverse to the cannula axis, has a proximal end that is integral with the housing and an open distal end; an electrical contact inside and at the proximal end of the handle, operatively coupled with said imaging module; a proximal port at a proximal end of the housing, an intermediate port at the fluid hub, and a distal port at a distal end of the cannula; an internal lumen from the proximal port to the distal port, in fluid flow communication with said proximal, intermediate and distal ports. Said fluid hub and cannula are mounted for rotation about the cannula axis relative to the housing. A manual rotation control at the proximal end of the housing is coupled with the fluid hub to rotate the fluid hub and cannula relative to the housing about the cannula axis. The endoscope in this example further includes an elongated reusable portion having a proximal part configured for insertion in the handle along the handle axis and having an electrical contact at a proximal end configured to mate with the electrical contact in the handle when the proximal part of the reusable portion is inserted in the handle; and a cap made of a flexible and resilient material, configured to cover the open distal end of the handle before the reusable portion is inserted in the handle, to be manually removed from the handle prior to insertion of the reusable portion in the handle, and after insertion of the reusable portion in the handle to cover a distal part of the reusable portion that protrudes from the handle along the handle axis as well as an adjacent part of the handle to thereby cover said protruding part of the reusable portion and an interface thereof with the handle.
According to some embodiments, the endoscope can further include one or more of the following features: (a) a sterile pouch enclosing said single use portion, with the cap over and covering the open distal end of the handle, before assembly of the single-use and reusable portions into said endoscope; (b) said reusable portion can includes a battery and control and processing electronics configured to control said imaging module to take images in a field of view and to receive image data from the imaging module, and further includes a facility to convey image data from the endoscope to an external processing/display unit; (c) said facility is configured to convey image data by wireless transmission using a proprietary protocol that is different from conventional WiFi; said facility in the reusable portion is configured to convert received image data into display images and convey display images to an external unit for display; (d) said facility comprises a wireless transmitter/receiver in said reusable portion and further including an external processing/display unit having a wireless transmitter/receiver configured to communicate wirelessly with said transmitter/receiver in the reusable portion and to receive wirelessly and process into display images image data received from the reusable portion, and a display configured to display said display images; (e) said external processing/display unit is configured to automatically search for and connect wirelessly with said reusable portion upon turning ON when the reusable portion is ON and in range; (f) said facility comprises an electrical contact at the distal end of the reusable portion configured to mate with a connector of a cable to an external processing/display unit, and said cap includes an opening for said connector configured to keep fluids from the environment from reaching the reusable portion around the connector; (g) a clip mounted to said cap and configured to releasably engage said connector to maintain contact between the connector and said contact at the distal end of the reusable portion; (h) more than four fifths of the length of the reusable portion along said handle axis are received in said handle in the assembled endoscope and less than a fifth protrudes from the handle; (i) more than three quarters of the length of the reusable portion along said handle axis are received in said handle in the assembled endoscope and less than a quarter protrudes from the handle; (j) said internal lumen has a constant internal size from said proximal port to said distal port; and (k) a manual switch at the distal end of the reusable portion, wherein at least the portion of the cap that is over the switch is sufficiently flexible for manual operation of the switch through the cap.
According to some embodiments, an endoscope comprises: a single-use portion comprising an elongated housing that extends along a cannula axis, a fluid hub that extends distally from the housing along the cannula axis, and a cannula that extends distally from the fluid hub along the cannula axis and has an imaging module at a distal end, and a handle that extends from the housing along a handle axis that is transverse to the cannula axis and is hollow and has an open distal end: wherein said single-use portion further comprises: a proximal port at a proximal end thereof, an intermediate port at said fluid hub, and a distal port at the distal end of the cannula; an internal lumen in fluid flow communicating with said ports; an electrical contact inside said hollow handle, at a proximal end thereof, that is operatively connected with said imaging module; a cap that is made of a flexible and resilient material and is configured to removably close said open distal end of the handle; and a sterile pouch enclosing said single-use portion, with the cap closing the open end of the hollow handle; wherein said handle is configured for insertion therein of a reusable portion after said cap is removed from the open end of the handle; and said cap is configured to cover the open end of the handle and an adjacent part of the reusable portion after insertion of the reusable portion in the handle to assemble the endoscope.
According to some embodiments, the endoscope described in the immediately preceding paragraph can further include one or more of the following features; (a) a reusable portion configured to be received in said hollow handle after manual removal of said cap from the handle, said reusable portion having a distal part protruding from the handle along said handle axis such that more than half the length of the reusable portion is within said hollow handle; (b) the hollow handle is configured to accept more than two thirds of the length of the reusable portion, so that less than one third of the length of the reusable portion protrudes distally from the handle; (c) the hollow handle is configured to accept more than three quarters of the length of the reusable portion, so that less than one quarter of the length of the reusable portion protrudes distally from the handle; and (d) an external processing/display unit having an image display and connected with the reusable portion wirelessly or by cable to receive and display image data from said imaging module.
According to some embodiments, the endoscope comprises: a single-use portion comprising an elongated housing that extends along a cannula axis, a cannula that extends distally from the housing along the cannula axis and has an imaging module at a distal end, and a hollow, funnel-shaped handle that is integral with the housing, extends from the housing along a handle axis that is transverse to the cannula axis, and has an open distal end; wherein said single-use portion further comprises: a proximal port at a proximal end thereof, a distal port at the distal end of the cannula, and an intermedial port between said proximal and distal ports, and an internal lumen in fluid flow communication with said ports. The endoscope further comprises: a reusable portion configured for manual insertion of a proximal part thereof into the hollow handle through said open distal end of the handle such that a protruding distal portion of the reusable portion protrudes distally from the handle; wherein said proximal part of the reusable portion is more than half the length of the reusable portion along said handle axis; and a cover made of a flexible and resilient material, configured to fit over the open end of the hollow handle before insertion of the reusable portion in the handle and to cover the protruding part of the reusable portion and an adjacent portion of the handle after insertion of the reusable part in the handle.
According to some embodiments, the endoscope described in the immediately preceding paragraph can further include one or more of the following features; (a) the handle is configured to accept more than two thirds of the reusable portion's length such that less than a third of the reusable portion's length protrudes distally from the handle; and (b) the handle is configured to accept more than three quarters of the reusable portion's length such that less than a quarter of the reusable portion's length protrudes distally from the handle.
DETAILED DESCRIPTIONA 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 such details. Moreover, for the purpose of clarity, certain technical material that is known in the related art has not been described in detail in order 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. Further, like reference numbers and designations in the various drawings indicate like elements.
As described in detail below, an endoscope according to a preferred embodiment is essentially self-contained, communicating with an external display unit wirelessly, for example via WiFi or a near field link, but can also have a port for a cable connection to an external display unit in case a wireless connection is not available or desirable at a medical site. The endoscope can contain a power source as well as sufficient electronics to control an imaging module at the distal end of a cannula and for processing image data from the imaging module into images for display so that only minimal control and/or processing is required at an external display to show the images. In other preferred examples, the external display unit can contain facilities to control some or all the functions of the imaging module and to do some or all the processing of image data from the imaging module for display.
According to some preferred embodiments, endoscope 100 wirelessly communicates with an external processing/display unit 1502 (
Preferably, endoscope 100 is provided with facilities both the wireless and for cable communication with an external processing/display unit. For cable communication, a contact 130 of a cable 132 plugs into a contact 134 (
Referring to
Notably, to ensure ease of assembling endoscope 100 and correctly fitting reusable portion 104 into handle 116, the handle and the reusable portion are shaped such that the reusable portion can be inserted in the handle in only one orientation. For example, as seen in
Still referring to
Reusable portion 104 can include a rechargeable battery 906 operatively coupled to power imaging module 114 through one of switches 140 and/or 502 and internal cables (not shown) in reusable portion 104 and single-use portion 102. In addition, reusable portion 104 can include electronics 908 communicating with imaging module 114 to control the imaging module and to process image data from the imaging module. According to some embodiments, electronics 908 can include a WiFi or near-filed facility to communicate with an external processing/display unit such as 1502, and facilities to fully or nearly fully control the operation of imaging module 114 through suitable switches and to fully or nearly fully process the image data from module 114 into images for display, so that an outside processing/display unit such as unit 1400 or 1502 needs to do only minimal processing of image data or of display images. According to some embodiments, some or all of the control over imaging module 114 and some or all the processing of image data from module 114 can be done at an external processing/display unit such as 1400 or 1502.
Importantly, when endoscope 100 is assembled, cap 128 covers not only the part of reusable portion 104 that protrudes distally from handle 116 but also an adjacent part of handle 116 to thereby seal the interface between the open end of handle 116 and reusable portion 104. Additional bumps can be provided on the inside of cap 128 to engage a channel 104c in the protruding distal part of reusable portion 104, to help keep cap 128 in place in the assembled endoscope 100.
According to some embodiments, wireless link 1402 is configured such that transmission between endoscope 100 and unit 1400 is automatically established. Unit 1400 is configured such that after being turned ON, it searches for an finds a wireless endoscope 100 that is within range and has been turned ON, for example by switch 140, Unit 1400 then automatically connects to this endoscope 100 for receiving and transmitting wireless data. This transmission can comprise image and/or other data from endoscope 100 and/or transmission of commands and/or other information from unit 1400.
Preferably, according to some embodiments the wireless transmission between endoscope 100 and unit 1400 uses a proprietary protocol and/or encoding designed to keep the transmitted information private, thus preserving confidentiality of medical information. This can limit or prevent access of public wireless receivers or transmitters to confidential information and possible corruption of the transmitted information by other actors.
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.
Claims
1. An endoscope comprising:
- a single-use portion comprising: an elongated housing extending along a cannula axis; a fluid hub extending distally along the cannula axis from the housing; a cannula that extends distally from the fluid hub along the cannula axis and has an imaging module at a distal end; a hollow, funnel-shaped, pistol-grip handle that extends from the housing along a handle axis that is transverse to the cannula axis, has a proximal end that is integral with the housing and an open distal end; an electrical contact inside and at the proximal end of the handle, operatively coupled with said imaging module; a proximal port at a proximal end of the housing, an intermediate port at the fluid hub, and a distal port at a distal end of the cannula; an internal lumen from the proximal port to the distal port, in fluid flow communication with said proximal, intermediate and distal ports; wherein said fluid hub and cannula are mounted for rotation about the cannula axis relative to the housing; and a manual rotation control at the proximal end of the housing coupled with the fluid hub to rotate the fluid hub and cannula relative to the housing about the cannula axis;
- an elongated reusable portion having a proximal part configured for insertion in the handle along the handle axis and having an electrical contact at a proximal end configured to mate with the electrical contact in the handle when the proximal part of the reusable portion is inserted in the handle; and
- a cap made of a flexible and resilient material, configured to cover the open distal end of the handle before the reusable portion is inserted in the handle, to be manually removed from the handle prior to insertion of the reusable portion in the handle, and after insertion of the reusable portion in the handle to cover a distal part of the reusable portion that protrudes from the handle along the handle axis as well as an adjacent part of the handle to thereby cover said protruding part of the reusable portion and an interface between the open distal end of the handle and the reusable portion.
2. The endoscope of claim 1, further comprising a sterile pouch enclosing said single use portion, with the cap over and covering the open distal end of the handle, before assembly of the single-use and reusable portions into said endoscope.
3. The endoscope of claim 1, in which said reusable portion includes a battery and control and processing electronics configured to control said imaging module to take images in a field of view and to receive image data from the imaging module, and further includes a facility to convey image data from the endoscope to an external processing/display unit.
4. The endoscope of claim 1, in which said facility is configured to convey image data by wireless transmission.
5. The endoscope of claim 3, in which said facility in the reusable portion is configured to convert received image data into display images and convey display images to an external unit for display.
6. The endoscope of claim 3, in which said facility comprises a wireless transmitter/receiver in said reusable portion and further including an external processing/display unit having a wireless transmitter/receiver configured to communicate wirelessly with said transmitter/receiver in the reusable portion and to receive wirelessly and process into display images image data received from the reusable portion, and a display configured to display said display images.
7. The endoscope of claim 6, in which said external processing/display unit is configured to automatically search for and connect wirelessly with said reusable portion upon turning ON when the reusable portion is ON and in range.
8. The endoscope of claim 3, in which said facility comprises an electrical contact at the distal end of the reusable portion configured to mate with a connector of a cable to an external processing/display unit, and said cap includes an opening for said connector configured to keep fluids from the environment from reaching the reusable portion around the connector.
9. The endoscope of claim 8, further including a clip mounted to said cap and configured to releasably engage said connector to maintain contact between the connector and said contact at the distal end of the reusable portion.
10. The endoscope of claim 1, in which more than four fifths of the length of the reusable portion along said handle axis are received in said handle in the assembled endoscope and less than a fifth protrudes from the handle.
11. The endoscope of claim 1, in which more than three quarters of the length of the reusable portion along said handle axis are received in said handle in the assembled endoscope and less than a quarter protrudes from the handle.
12. The endoscope of claim 1, in which said internal lumen has a constant internal size from said proximal port to said distal port.
13. The endoscope of claim 1, further comprising a manual switch at the distal end of the reusable portion, wherein at least the portion of the cap that is over the switch is sufficiently flexible for manual operation of the switch through the cap.
14. (canceled)
15. (canceled)
16. (canceled)
17. (canceled)
18. (canceled)
19. (canceled)
20. (canceled)
21. (canceled)
Type: Application
Filed: Apr 13, 2022
Publication Date: Oct 19, 2023
Inventors: Xiaolong OUYANG (Bellevue, WA), Shih-Ping Wang (Los Altos, CA)
Application Number: 17/720,143