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.

FIELD

This 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.

BACKGROUND

Conventional 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.

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.

SUMMARY OF THE DISCLOSURE

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 DESCRIPTION

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 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.

FIG.1is a perspective view of an assembled endoscope100andFIGS.2,3aand3bare exploded view of an endoscope100, according to some embodiments. Endoscope100comprises a single-use portion102and a reusable portion104that when assembled form an endoscope. Single-use portion102comprises an elongated housing106that extends along a cannula axis108, a fluid hub110that extends distally along the cannula axis108from housing106, and a cannula112that extends distally from the fluid hub110along cannula axis108and has an imaging module114at its distal end. Single-use portion102further comprises a hollow, funnel-shaped, pistol-grip handle116that extends from housing106along a handle axis118that is transverse to cannula axis108, has a proximal end that is integral with housing106and an open distal end120(FIG.2). Single-use portion102further comprises an electrical contact302(FIG.3a) inside and at the proximal end of handle116, an internal lumen902(FIG.9), a proximal port122at the proximal end of housing106, an intermediate port124at fluid hub110, and a distal port126at the distal end of cannula112. Each of ports122,124and126is in fluid flow communication with internal lumen904, which extends along cannula axis108all the way from port122to port126and preferably has a substantially constant cross-section. A cap128is made of a flexible and resilient material such as silicone and covers the distal end of handle116.

According to some preferred embodiments, endoscope100wirelessly communicates with an external processing/display unit1502(FIG.15). In other preferred embodiments, endoscope100communicates with an external processing/display unit1400(FIG.14) via a cable connection. In some preferred embodiments, endoscope100is provided both with an internal battery for controlling imaging module114and for processing image date therefrom into images and with a port for a cable connection to an external processing/display unit1400.FIGS.1and2illustrate a port with a contact134for cable connection to processing/display unit1400but is should be understood that this port may be omitted in examples of an endoscope100that only communicates wirelessly with an outside unit such as1502.

Preferably, endoscope100is provided with facilities both the wireless and for cable communication with an external processing/display unit. For cable communication, a contact130of a cable132plugs into a contact134(FIG.2) at the distal end of reusable portion104through an opening136in cap128. Another opening138accepts an electrical switch140protruding distally from the distal end of reusable portion104, and a smaller cap142covers and seals opening138. Note thatFIG.2illustrates a variation of the configuration ofFIG.1—inFIG.1electrical contact134and switch140are spaced from each other in the direction of cannula axis108while inFIG.2they and their respective openings138and166are spaced in a direction perpendicular to axis108and are closer to each other. Still in addition, single-use portion102includes a thumb wheel144that is coupled with cannula112through fluid hub110such that manual rotation of thumb wheel142about cannula axis108rotates cannula112(and preferably hub110as well) around cannula axis108. Preferably, a clip148is anchored on cap128and swings to keep connector130in place. In examples where only wireless communication is desirable, contact130and cable132and its plug130, as well as clip148, can be omitted, and the distal wall of cap128need not have an opening such as136.

Referring toFIG.2, reusable portion104is elongated along axis118and is configured for insertion in handle116. At a proximal end, reusable portion104has an electrical contact146(FIG.3b) that mates with electrical contact302(FIG.3a) in handle116when reusable portion104is inserted all the way into handle116. Internal cables (not shown) connect imaging module114with cable132through contacts302,146and134and connector130for transfer of power and image data. As noted, contact134can be omitted in examples that do not need cable communication to an outside processing/display unit.

Notably, to ensure ease of assembling endoscope100and correctly fitting reusable portion104into handle116, 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 inFIG.2, the left side of open end120of handle116is less curved that the right side and the proximal end of reusable portion104is similarly shaped to ensure that the insertion orientation is correct and will result in mating electrical contacts302and146. Note that the distal part of reusable portion104is larger, so that reusable portion104cannot be inserted backward into handle116.

FIGS.3aand3bare exploded views of endoscope100from different viewpoints. A noted above, the orientation and spacing of elements such as openings136(and switch140) and138(and contact134) are variations of those inFIG.1. Like-numbered component are the same or similar and serve the same or similar functions inFIGS.1-3bas in all other figures.

FIG.4is a perspective view of single-use portion102, with cap128removably secured to and covering the open end of handle116, in a sterile pouch400, according to some embodiments. Preferably, single-use portion102and cap128are packaged in this manner at the manufacturing site and kept in this form until needed for a medical procedure. For a medical procedure, sterile pouch400is torn and discarded, cap128is removed manually from handle116, reusable portion104is inserted in handle116, and cap128that was removed from handle116is now placed over the distal end of reusable portion104and an adjacent part of handle116. In the example of providing for a cable connection to an outside processing/display unit, connector130plugs in to mate with contact134to thereby connect the so-assembled endoscope100to an external display and/or image processing unit described further below. Also described further below are details about how cap128is kept in place and how it seals reusable portion104and the interior of handle116.

FIGS.5-8are, respectively, a side elevation, a back elevation, a top view, and a front elevation of endoscope100, according to some embodiments.FIG.5illustrates a switch502that is positioned for operation by a user's forefinger and can serve a function such as taking a photo or a video clip with imaging module114or some other function. The switch at142can be used for the same or different function, such as powering imaging module114. In other respects,FIGS.5-8illustrate the same endoscope100, accounting for the variations in orientation and spacing of components at the distal end of reusable portion104and cap128described above.

FIG.9shows an important feature of endoscope100—nearly the entire length of reusable portion104is inside handle116, according to some embodiments. For example, more than 9/10, or ⅘, or ¾, or ½ of the length of reusable portion along axis118is received in handle116. The minor part of the length of reusable portion104that protrudes distally from handle116is covered with cap128, and the cap also covers an adjacent portion of handle116. In this configuration, cap128an hollow handle116protect the entire reusable portion104from contamination in a medical procedure. After the medical procedure, cap128is removed by hand, reusable portion104pulls out of handle116, single-use portion102is discarded as medical waste, and reusable portion104only needs moderate cleaning or disinfection before being assembled in a new endoscope100with another, new single-use portion102.

Still referring toFIG.9, a proximal portion of lumen902can have a duck bill valve904at its distal end, which valve is normally closed to prevent backflow of fluid out of proximal port122. However, the leading end of a surgical implement (not shown) introduced distally through proximal port122spreads valve904so the surgical instrument can move distally through valve904and then through the rest of lumen904all the way through housing106, hub110, and cannula112and to exit through distal port126. Preferably, intermediate port124communicates with the same lumen902such that fluid injected into port124can be expelled through distal port126or suction applied to port124can extract fluid entering through distal port126. If no fluid flow through port124is desired, the port can be closed with a cap (not shown).

Reusable portion104can include a rechargeable battery906operatively coupled to power imaging module114through one of switches140and/or502and internal cables (not shown) in reusable portion104and single-use portion102. In addition, reusable portion104can include electronics908communicating with imaging module114to control the imaging module and to process image data from the imaging module. According to some embodiments, electronics908can include a WiFi or near-filed facility to communicate with an external processing/display unit such as1502, and facilities to fully or nearly fully control the operation of imaging module114through suitable switches and to fully or nearly fully process the image data from module114into images for display, so that an outside processing/display unit such as unit1400or1502needs to do only minimal processing of image data or of display images. According to some embodiments, some or all of the control over imaging module114and some or all the processing of image data from module114can be done at an external processing/display unit such as1400or1502.

FIGS.10and11are exploded perspective view showing details of cap128and the distal portion of reusable portion104from two viewpoints, according to some embodiments. Referring toFIG.10, the distal end of reusable portion104is larger than the remainder of portion104and ends at a ledge104aso that when portion104is fully inserted in housing116this ledge104ais flush with the opening120(FIG.2) in hollow handle116. The distal part of reusable portion104can have ribbed portions104bto help a user grasp and hold portion104when inserting in handle116or withdrawing from handle116. Cap128preferably has at its internal surface bumps128aconfigured to be positioning distally of a rib116a(FIG.2) that surrounds and extends radially outwardly from opening120in handle116when endoscope100is assembled as seen inFIG.1, to thereby help keep cap128in place.

Importantly, when endoscope100is assembled, cap128covers not only the part of reusable portion104that protrudes distally from handle116but also an adjacent part of handle116to thereby seal the interface between the open end of handle116and reusable portion104. Additional bumps can be provided on the inside of cap128to engage a channel104cin the protruding distal part of reusable portion104, to help keep cap128in place in the assembled endoscope100.

FIG.10also shows the sheet128cmade of a soft and pliable material that sits at the inside of a distal wall128d(FIG.11) of cap128and helps seal the distal end of reusable portion104and especially switch140and the interface between contact134and connector130from the environment. Sheet128chas an opening136for connector130. Cap128has two indentations128b, of which only one is visible, to anchor clip148such that the clip can pivot about those indentations to lock connector130in place of to release it so connector130can pull from endoscope100and the endoscope can be disassembled by pulling out cap128and then pulling out reusable portion104from single-use portion102.FIG.11illustrates the same components asFIG.10but from a different viewpoint. InFIG.11, switch140is visible, and sheet128cin this case shows the smaller cap142that covers the opening138(FIG.3) through which switch140can extend when endoscope100is assembled. The arrow inFIG.11shows where wall128dis in cap128.

FIG.12is an exploded perspective view of a distal portion of cannula112, according to some embodiments. Video camera14aand LED lights114bfit in respective openings14a′ and14b′ in a housing1202secured at the distal end of cannula112such that the camera and LEDs face in the distal direction. Cameral14aand LEDs14bcan be configured to have a field of view and a direction of illumination having a central axis1204that is at an angle to cannula axis108, for example a 30 degrees angle.

FIG.13is an exploded perspective view of components of single-use portion102and reusable portion104, according to some embodiments. Many of the components are designated by reference numerals discussed above. The component of single-use portion102seen only inFIG.13include a cap1306for thumbwheel144, an O-ring1308to seal thumbwheel144against housing106, a bridge tube1310connecting proximal port122and thumbwheel144to fluid hub110and a seal1312sealing tube1310to housing106. The component of reusable portion104that are seen only inFIG.13are two half shells1302and1304that form handle when affixed to each other. As noted, components related to a cable connection with an external unit can be omitted in examples where only a wireless connection is desired.

FIG.14is a perspective view of an endoscope100and an external processing/display unit or station1400that connects with endoscope100through a wireless link1402and/or through cable132and contact130in the example where a cable connection is used. Unit1400is powered through a plug1404from an electrical outlet. Unit or station1400comprises a display1406configured to display images from camera114at the distal end of cannula112and/or other data and images, a row of switches1408configured to control functions of endoscope100and station1400, and an on-off switch14108. In addition, station1400has a cradle1412for reusable portion104that may include provisions (not shown) for charging battery906in reusable portion104. In addition. Unit1400can include a cable and an HDMI1412or another high-speed connector for a data link to an external display1414that can be a large and/or high-definition monitor or a workstation. Wireless link1402also can be used for a connection of endoscope100and/or unit1400with another device such as a smartphone or a tablet or a workstation. The wireless link can be WiFi link or can use a near filed communication protocol (NFC) or another protocol.

According to some embodiments, wireless link1402is configured such that transmission between endoscope100and unit1400is automatically established. Unit1400is configured such that after being turned ON, it searches for an finds a wireless endoscope100that is within range and has been turned ON, for example by switch140, Unit1400then automatically connects to this endoscope100for receiving and transmitting wireless data. This transmission can comprise image and/or other data from endoscope100and/or transmission of commands and/or other information from unit1400.

Preferably, according to some embodiments the wireless transmission between endoscope100and unit1400uses 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.