EP3570723A1 - Handheld surgical endoscope - Google Patents

Abstract

A handheld surgical endoscope has a reusable portion and a disposable, single- use portion that includes a fluid hub, cannula, distal tip and an integrated, internally mounted needle moved between a retracted and an extended position with a finger actuated tab. The distal tip includes LED illumination and an imaging module that can be digital and feeds live video to the display module that is rotatable to allow viewing by the operator and others. The imaging module can have a wide field of view (FOV), e.g. 140°, using no more than 2 lenses, and the LEDs are arranged to have a field of illumination (FOI) that matches the FOV. Provisions can be included to equalize image brightness when the imaged surface is not uniformly illuminated. The single-use and re-usable portions mate and un-mate with each other via physically well-separated mechanical and electrical connectors. The needle delivers liquid from a syringe that can be attached to the handle to move therewith or only connected to the endoscope by a flexible conduit. The surgical endoscope is configured for operation by a single clinician in many procedures.

Description

HANDHELD SURGICAL ENDOSCOPE

REFERENCE TO RELATED APPLICATIONS

[0001] This patent application claims the benefit of and incorporates by reference each of the following provisional applications:

U.S. Prov. Ser. No. 62/449,257 filed January 23, 2017; U.S. Prov. Ser. No. 62/452,883 filed January 31 , 2017; U.S. Prov. Ser. No. 62/513,386 filed May 31 , 2017;

U.S. Prov. Ser. No. 62/530,238 filed July 9, 2017;

U.S. Prov. Ser. No. 62/531 ,212 filed July 1 1 , 2017;

U.S. Prov. Ser. No. 62/573,380 filed October 17, 2017; U.S. Prov. Ser. No. 62/578,407 filed October 28, 2017; and

U.S. Prov. Ser. No. 62/594,013 filed December 3, 2017.

[0002] This patent application also claims the benefit of and incorporates by reference each of the following U.S. patent applications:

U.S. Ser. No 15/462,331 filed March 17, 2017;

U.S. Ser. No. 15/651 ,526 filed July 17, 2017; and

U.S. Ser. No. 15/855,532 filed December 27, 2017. FIELD

[0003] This patent specification generally relates to a medical device for use in tissue examinations and endoscopic surgery such as in urology. More particularly, some embodiments relate to an integrated, handheld, low-cost surgical endoscope device having a DISPOSABLE, single-use portion and a reusable, multiple-use portion.

BACKGROUND

[0004] Conventional endoscopy, or direct vision endoscopy, used to examine the interior of a hollow organ or cavity of the body, typically uses a complex lens system for transmitting the image from the distal tip of the endoscope to a viewer. The lens system commonly is a relay lens system in rigid endoscopes or a bundle of fiber optics or an objective lens system in flexible endoscopes. In both rigid and flexible conventional endoscopes, the lens or fiber optic system is relatively

1 expensive and is intended to be re-used many times. Therefore, stringent decontamination and disinfection procedures need to be carried out after each use.

[0005] In surgical procedures where a needle is used to inject fluid such as a drug into the patient's tissues, a long injection needle is inserted into the working channel of the endoscope. In such procedures, it is common to use two or more operators to carry out the surgical procedure: one to operate the endoscope and another to operate the needle assembly and syringe. It is common for there to be a physical separation between the display screen (e.g. mounted overhead), the endoscope (into the patient), and/or the syringe used to administer the drug. In such cases an operator or clinician has to look up the display screen and cannot simultaneously view the scope handle and the syringe. Furthermore, the separate needle assembly which is often long and somewhat cumbersome needs to be threaded through the working channel of the endoscope and substantial manual dexterity may be required to control the jabbing and injection process.

[0006] Disposable endoscopy is an emerging 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. Partially disposable endoscopy systems for hysteroscopy are discussed in U.S. Pat. 8,460, 182, incorporated by reference herein. A hysteroscope having a disposable probe was offered by Endosee Corporation of Los Altos, CA, and is now offered by CooperSurgical, Inc. of Trumbull, CT, a company that acquired EndoSee Corporation.

[0007] The known partly disposable hysteroscope has a miniature video camera at the tip of its disposable portion. The tip has a small diameter, which makes it difficult to incorporate a lens system in it. In the known disposable endoscope, the camera field of vie (FOV) is no more than about 120°, so the user may need to frequently reposition the tip to include different areas of the uterus in the camera FOV. For endoscopes that are suitable for larger or differently shaped organs, such as the bladder, viewing different areas of the bladder interior may require even more frequent repositioning of the camera tip with such an FOV. This is undesirable because it makes the examination longer, and also because it prevents the concurrent viewing of a larger area in the organ.

2 [0008] The tip of some known endoscopes includes light sources such as LEDs to illuminate the object or surface being viewed. The illuminated field may not be the same as the camera FOV, so that some of the camera FOV is not illuminated and thus is not imaged well and/or some of the illumination is wasted in that it does not contribute to imaging because it illuminates an area not currently seen by the camera.

[0009] In addition, in some known endoscopes the illumination may impair imaging depending on the position and orientation of the camera relative to the organ being imaged. For example, if one set of LEDs is much closer to the organ wall than another set, one area of the wall can be illuminated more and can appear brighter and even saturate that area of the image, making image assessment more difficult.

[0010] 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

[0011] Some embodiments comprise an endoscope having a multiple-use, reusable proximal portion and a single-use, disposable distal portion carrying entirely internally a needle movable between a retracted position in which the needle is within the disposable portion and an extended position in which a distal end of the needle protrudes from a distal tip of the disposable portion. The endoscope can include: a handle configured to be grasped by the user's hand and having at least one button controlling endoscope functions, and a video display screen mounted to the handle, wherein the handle and the screen form a part of the reusable portion of the endoscope; a cannula forming a part of the disposable portion of the endoscope; a connector at a proximal part of the disposable portion of the endoscope, configured to releasably mate tool-free with a connector at the reusable portion of the endoscope thereby releasably integrating the reusable and disposable portions; a needle actuation tab mounted to the endoscope and positioned and configured to be moved between a retracted position and an

3 extended position by the user grasping the handle; said needle actuation tab being coupled to said needle to drive it between its retracted and extended positions as the user moves the tab between its retracted and extended positions; an injection fluid port at a proximal part of the disposable portion, said port being in fluid communication with the injection needle through the cannula so that fluid introduced in the port is injected through the needle; and an imaging module with a video camera at said tip of the cannula, coupled with the screen to provide images to the screen, and a light source at the tip of the cannula configured to illuminate a region viewed by the camera, under control of said buttons on the handle. [0012] In some embodiments, the endoscope can further include one or more of the following elements of features: (1 ) a source of fluid and a flexible conduit from the source to the injection fluid port, wherein the flexible conduit is the sole connection between the source of fluid and the endoscope; (2) a syringe releasably secured to the handle and coupled with the fluid port to enable the operator to use a single hand to operate the endoscope to visualize a region of the patient, to move the needle between its retracted and extended positions and jab the needle into tissue, and to inject fluid into the tissue; (3) a field of view (FOV) of the imaging module that includes the distal tip of the needle at a central region of the FOV when the needle is in its extended position; (4) a direction of view (DOV) of the video camera that is angled relative to the direction in which the cannula tip extends; (5) said needle actuation tab has a projection moving with the tab, and the endoscope has stops configured to releasably engage the projection at each of the retracted and extended positions of the needle actuation tab and thereby releasably lock the tab at least in its extended position, and the endoscope further includes a hand-operated release button acting on said projection to thereby selectively release the tab and thus the needle from a locked position; (6) said cannula is secured to said disposable portion for selective rotation of the cannula about a long axis thereof; (7) said needle is no longer than the distance from said fluid port to the distal end of the cannula; (8) said connector comprises a mechanical connector at each of the reusable and disposable portions and an electrical connector at each of the reusable and disposable portions, wherein the electrical connectors are spaced proximally from the mechanical connectors by a distance of 2 cm or more, and said connectors releasably integrate the reusable

4 and disposable portions into said endoscope tool-free; (9) said video camera in the imaging module is a digital camera transmitting digital video images from the cannula distal end to said electrical connectors; (10) the cannula tip at said video camera has an outside diameter of 4 mm or less, or 3 mm or less; (1 1 ) said imaging module in said disposable portion has a field of view (FOV) of 140° or more, or 130° or more; (12) said imaging module comprises an image sensor array, and no more than two lenses providing a field of view (FOV) of the imaging module of no less than 130°; (13) the lenses extend no more than 4 mm from said image plane; (14) each of said lenses is made of a molded polymer material; (15) said light source comprises plural LEDs arranged symmetrically around a long axis of said cannula and having a field of illumination (FOI) that matches a field of view (FOV) of said imaging module thereby avoiding blind spots or unevenly illuminated FOV; (16) the endoscope further includes a circuit controlling the areal distribution of illumination from said light source to reduce brightness imbalance between portions of images provided by said imaging module; (17) the circuit controlling said areal distribution comprises a hand-operated control on said reusable portions and a circuit responsive to said hand-operated control to vary the distribution of illumination from said light source to reduce brightness imbalance between portions of images provided by said imaging module; (18) the endoscope further includes a circuit responsive to imbalance in brightness between areas of said images provided by the imaging module to automatically reduce said imbalance by varying the areal distribution of illumination from said light source; (19) said imaging module has a field of view that includes a distal length of said needle, and said display has markings at a length of the needle visible on the display that show to what depth the needle has been inserted in tissue; (20) said distal length of the needle has markings that show on said display to what extent the needle has been inserted in tissue; and (21 ) both said display and said needle have markings that show on the display a depth of penetration of the needle in tissue in use of the endoscope. [0013] In some embodiments, an endoscope having a multiple-use reusable proximal portion and a single-use, disposable distal portion, comprises: a handle configured to be grasped by the user's hand and having at least one button controlling endoscope functions, and a video display screen mounted to the

5 handle, wherein the handle and the screen form a part of the reusable portion of the endoscope; a cannula forming a part of the disposable portion of the

endoscope; a connector at a proximal part of the disposable portion of the endoscope, configured to releasably mate tool-free with a connector at the reusable portion of the endoscope thereby releasably integrating the reusable and disposable portions; and an imaging module with a video camera at a tip of the cannula, coupled with the screen to provide images to the screen, and a light source at the tip of the cannula to illuminate a region viewed by said camera, under the control of said buttons on the handle; wherein said video camera is a digital camera providing a digital image output delivered to said video display screen; and wherein said tip of the cannula has an outside diameter no greater than 4.2 mm and said imaging module comprises an image sensor with an image plane no wider or taller than 3 mm. The endoscope can further include one or more of the following elements or features: (1 ) said digital camera comprises an image sensor having an image plane with linear dimensions no greater than 3 mm; (2) said imaging module comprises a lens system providing a field of view of no less than 130°; (3) said lens system uses no more than two lenses; (4) said lenses extend no more than 4 mm from said image plane; (5) the endoscope further comprises a needle that is entirely contained in said disposable portion of the endoscope and has an extended position in which it protrudes distally from said cannula, wherein said imaging module has a field of view that includes a distal length of said needle, and further including markings on one or both of said display and said needle, which markings show on the display a depth of penetration of the needle in tissue in use of the endoscope. [0014] In some embodiments, an endoscope having a multiple-use, reusable proximal portion and a single-use, disposable distal portion, comprises: a handle configured to be grasped by the user's hand and having at least one button controlling endoscope functions, and a video display screen mounted to the handle, wherein the handle and the screen form a part of the reusable portion of the endoscope; a cannula forming a part of the disposable portion of the

endoscope; a connector at a proximal part of the disposable portion of the endoscope, configured to releasably mate tool-free with a connector at the reusable portion of the endoscope thereby releasably integrating the reusable and

6 disposable portions; an imaging module with a video camera at a tip of the cannula, coupled with the screen to provide images to the screen, and a light source at the tip of the cannula to illuminate a region viewed by the camera, under the control of said buttons on the handle; and a circuit coupled with said light source and configured to control the areal distribution of illumination from said light source to reduce brightness imbalance between portions of said images. The endoscope can further include one or more of the following elements or features: (1 ) a hand-operated control on said reusable portions, wherein said circuit is responsive to said hand-operated control to vary the distribution of illumination from said light source to thereby reduce brightness imbalance between portions of images shown on said screen; (2) said circuit is responsive to imbalance in brightness between areas of said images provided by the imaging module to automatically reduce said imbalance by varying the areal distribution of illumination from said light source; (3) said light source comprises plural LEDs at each of two sides of a long axis of said cannula, and said circuit is configured to vary the illumination from the LEDs on one of said sides relative to the illumination from the other of said sides.

In some embodiments, a single-use, disposable distal portion is configured to releasably mate with a multiple-use reusable proximal portion to thereby form an endoscope, said disposable portion comprising: a cannula having a connector at a proximal part thereof, configured to releasably mate tool-free with the reusable portion to thereby releasably integrate the reusable and disposable portions; and an imaging module with a video camera at a tip of the cannula configured to provide images of a region, and a light source at the tip of the cannula to illuminate the region viewed by said camera; wherein said video camera is a digital camera providing a digital image output for delivery to said reusable portion; and wherein said tip of the cannula has an outside diameter no greater than 4.2 mm and said imaging module comprises an image sensor with an image plane no wider or taller than 3 mm. The endoscope can further include one or more of the following elements or features: (1 ) an injection needle carried entirely within said disposable portion and movable between a retracted position in which the needle is within the disposable portion and an extended position in which a distal end of the needle protrudes from a distal tip of the disposable portion; (2) said imaging module has a

7 field of view of at least 130° that includes a distal length of said needle, and further including markings on one or both of said display and said needle, which markings show on the display a depth of penetration of the needle in tissue in use of the endoscope; (3) said imaging module comprises a lens system providing a field of view of no less than 130°; (4) said lens system uses no more than two lenses; and (5) said lenses extend no more than 4 mm from said image plane.

[0015] As used herein, the grammatical conjunctions "and", "or" and "and/or" are all intended to indicate that one or more of the cases, object or subjects they connect may occur or be present. In this way, as used herein the term "or" in all cases indicates an "inclusive or" meaning rather than an "exclusive or" meaning.

[0016] As used herein the terms "surgical" or "surgery" refer to any physical intervention on a patient's tissues, and does not necessarily involve cutting a patient's tissues or closure of a previously sustained wound. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] 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 elements or components illustrated in one figure can be used in place of comparable or similar elements or components illustrated in another, and 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 use of the accompanying drawings in which:

[0018] FIGs. 1 and 2 are a right side view and a top view, respectively, of a handheld surgical endoscope, according to some embodiments;

[0019] FIG. 3 is perspective view showing aspects of attachment and detachment of single-use and reusable portions of a handheld surgical endoscope, according to some embodiments;

[0020] FIGs. 4A, 4B, and 4C are a side view, perspective view, and cross section of a cannula of a handheld surgical endoscope, according to some embodiments;

8 [0021] FIGs. 5A and 5B are perspective views showing aspects of needle actuation for a handheld surgical endoscope, according to some embodiments;

[0022] FIGs. 6A and 6B are perspective views of distal tip of a cannula and show aspects of needle actuation, according to some embodiments;

[0023] FIG. 7A and 7B are perspective views of parts of a single-use portion of a handheld surgical endoscope, according to some embodiments;

[0024] FIGs. 8A and 8B are side and cross section views of a distal tip of a handheld surgical endoscope, according to some embodiments;

[0025] FIG. 9 is a perspective view of a handheld surgical endoscope being used to perform a surgical procedure by a single operator, according to some embodiments;

[0026] FIGs. 10A and 10B are further perspective views of a handheld surgical endoscope being used to perform a surgical procedure by a single operator, according to some embodiments;

[0027] FIG. 1 1 is a perspective view of a handheld surgical endoscope, according to some embodiments;

[0028] FIG. 12 is a block diagram showing aspects of single operator carrying out a surgical procedure with a handheld surgical endoscope, according to some embodiments;

[0029] FIGs. 13 and 14 are perspective views of a handheld surgical endoscope having a clip for attaching a syringe to the handle, according to some embodiments;

[0030] FIG.15 is a block diagram of the electronics in the single-use and the re-usable portions of an endoscope, according to some embodiments;

[0031] FIG. 16 is a system block diagram of signal flow through a digital signal processor in an endoscope, according to some embodiments;

[0032] FIG. 17 is a perspective illustration of an example of an endoscope with an indication of a cannula working length that can be different for different cannulas, according to some embodiments;

[0033] FIG. 18 illustrates an endoscope that has a rigid or semi-rigid cannula, according to some embodiments;

9 [0034] FIGs. 19A-19E illustrate an endoscope that also has a rigid or semi-rigid cannula but can be configured with different directions of view (DOV) of a camera at the cannula tip, according to some embodiments;

[0035] FIG. 20 illustrates an endoscope that can be configured with directions of view (DOV) of a camera at the cannula tip that exceed a right angle to the cannula length and can even operate with the camera looking backward, according to some embodiments;

[0036] FIG. 21 is an exploded view of a distal part of a single-use portion of an endoscope, according to some embodiments;

[0037] FIG. 22A shows in magnification a detail of FIG. 21 , and FIGs. 22B,

22C, and 22 D are, respectively, a front view, a side view, and a sectional view of a distal tip of a single use portion of an endoscope, according to some embodiments;

[0038] FIG. 23 is a sectional view showing a lens barrel that houses a lens system providing a wide field of view at a sensor plane of an imaging sensor in a single-use portion of an endoscope, according to some embodiments;

[0039] FIG. 24A is a schematic illustration of matching fields of illumination

(FOI) and field of view (FOV), according to some embodiments of an endoscope;

FIG. 24B illustrates a mismatch between FOI and FOV in a prior art endoscope; and FIG. 24C is a schematic illustration of an image with imbalance in image brightness between areas of the image due to mismatch of the FOI and FOV and/or different distances of LEDs from the surface being imaged, according to some embodiments;

[0040] FIG. 25 illustrates an example of a control circuit for equalizing illumination and image brightness balance under manual control, according to some embodiments;

[0041] FIG. 26 illustrates an example of an automated control circuit for equalizing illumination and image brightness balance, according to some embodiments;

[0042] FIG. 27 illustrates a screen image in a system providing visual control over insertion depth of a needle at a cannula tip, according to some embodiments;

[0043] FIGs. 28A, 28B, and 28C illustrate screen images at three different needle insertion depths, according to some embodiments; and

10 [0044] FIG. 29 illustrates a needle with markings facilitating visual control over insertion depth, according to some embodiments.

DETAILED DESCRIPTION

[0045] A detailed description of examples of preferred embodiments is provided below. While several embodiments are described, it should be understood that 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 in order to provide a thorough understanding, some embodiments can be practiced without some or all of these 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.

[0046] FIGs. 1 and 2 are a right side view and a top view, respectively, of a handheld surgical endoscope, according to some embodiments. The surgical endoscope 100 includes an elongated cannula 120 with a distal tip 1 12 for inserting into a hollow organ or cavity of the body. A needle 1 14 passes through a dedicated lumen in cannula 120. The tip of needle 1 14 can be extended to protrude distally from distal tip 1 12 as shown. The needle 1 14 is hollow and at needle actuation hub 170 is in fluid communication with fluid line 172, which in turn is connected to syringe 180 (or other fluid dispensing device).

[0047] According to some embodiments, a separate tip sub-assembly 1 10 is attached to the cannula 120 which can be made from an extruded material. For further details relating to a separate tip sub-assembly for a handheld endoscope, see U.S. Pat. Appl. Ser. No. 15/371 ,858 filed December 7, 2016 and published as US 2017-0188795 A1 . Sub-assembly 1 10 includes an imaging module and one or more LED light sources for viewing the organ or cavity into which tip assembly 1 10 is inserted. The tip assembly 1 10 also includes one or more fluid ports. The distal

1 1 end of the cannula 120 can be bent in region 122, for example to the position shown in FIG. 1 . According to some embodiments, a bend of about 15 degrees in region 122 has been found to be suitable for many applications, but using other angles in alternative embodiments is not excluded.

[0048] According to some embodiments, the cannula 120 includes one or more fluid channels which are fluidly connected to fluid port 132 at fluid hub and connection assembly 130. Port 132 includes a Luer fitting to facilitate leak-free connection of port 132 with various medical fluid components. The fluid channels or lumens in cannula 120 are also connected to a distal facing fluid ports (orifice or ports 616 and 618 shown in FIGs. 6A, and 6B) of tip assembly 1 10. According to some embodiments, wires running from the LED light sources and camera module in tip assembly 1 10 pass through a separate channel in cannula 120.

[0049] The endoscope 100 includes a handle portion 140 that is sized and shaped in a pistol-like fashion for easy grasping by the endoscope operator (e.g. doctor or other medical professional). A display module 150 is rotatably mounted on handle 140 via a bearing which can be a plain bearing made of plastic, and a rubber coated hinge. Also visible on handle 140 are image capture button 160 and power button 162. (The function of button 2512 is explained below in connection with FIG. 25.) According to some embodiments handle 140 and display module 150 are configured to be re-usable and make up reusable portion 102. According to some embodiments, handle 140 is similar or identical to handle 140 shown and described in said application published as US 2017-0188795 A1 .

[0050] Single-use portion 104 includes the needle actuation hub 170, fluid hub and connection assembly 130, cannula 120 and tip assembly 1 10. Single-use portion 104 is made at a relatively low-cost and is intended to be disposed of after a single-use. By making the tip, cannula, fluid hub all single-use, stringent decontamination and disinfection procedures as well as the risk of cross- contamination and hospital acquired diseases can be significantly lessened or avoided. According to some embodiments the disposable, single-use portion (portion 104 shown in FIG. 1 and 3) is sterilized, for example, during production and is provided to the user in a sealed sterilized pouch, for ease of storage and handling. The camera module in the tip assembly can have a wide angle of view, such as 140° in this example, and in some embodiments can be implemented

12 through the use of no more than two lenses, as described in more detail below. According to some embodiments, the fluid line 172 is also included in single use portion 104 and can be attached to hub 170 and included in the same sterilized pouch.

[0051] According to some embodiments, the length of needle 1 14, including the fluid pathway within needle actuation hub 170 (i.e. from the distal tip of needle 1 14 to the needle fluid port 174 is less than 50 cm, and according to some

embodiments is about 37 cm. This is in contrast to surgical procedures carried out with a conventional endoscope having a working channel through which is passed a separate needle assembly. In those cases the separate needle assembly typically is operated by a second clinician which necessitates a longer needle (e.g. between 70 cm to 100 cm) to allow for enough working space for each clinician. Using a much shorter needle, according to the embodiments described herein, allows for less wasted drug fluid remaining within the needle and easier

manipulation in patient procedures.

[0052] According to some embodiments, the surgical endoscope is configured to allow cannula 120 to rotate about its longitudinal axis as shown by the arrow in FIG. 1 . For further details of how to configure the hub 130 to allow rotation of the cannula, see said application published as US 2017-0188795 A1 . According to some embodiments, the cannula rotation can include a certain amount of friction (e.g., friction overcome by torque in the range of 0.04 N m to 0.2 N m). This allows for a "rotate and hold" of the cannula, which is desirable for some procedures. For further details of how to configure such a "frictional fit," see said application published as US 2017-0188795 A1 . According to some embodiments, the endoscope can be configured to detect the rotational position of the cannula 120 relative to the handle 140. The detected rotational position is then input to a software algorithm configured to reorient the image displayed on display module 150 such that a correctly oriented image is displayed to the operator. For further details of such rotational position detection, see said application published as US 2017-0188795 A1 .

[0053] FIG. 3 is perspective view showing aspects of attachment and detachment of single-use and reusable portions of a handheld surgical endoscope, according to some embodiments. The single-use portion 104 and reusable portion

13 102 attach mechanically primarily via mating mechanical connectors 320 and 322. Electrical connection is made via separate mating electrical connectors 310 and 312. In this example the two portions 102 and 104 are attached mechanically via translation vertically towards each other. Note that the electrical connector 310 and mechanical connector 320 are both separated from the fluid hub 130 and from needle actuation hub 170. This separation allows for easy and effective, yet simple and inexpensive, fluid sealing to prevent fluid from hubs 170 and 130 from penetrating internally towards connectors 310 and 320 and also allows some protection against any exterior fluid, for example from fluid port 132 from reaching and possibly compromising electrical connectors 310 and 312. Also, the separation between mechanical connector 320 and hub 130 allows for a sleeve bearing to allow for rotating cannula 120 relative to the proximal portion of hub 130. For further details of this rotation mechanism, see said application published as US 2017-0188795 A1 , for example FIGs. 8A-8C and 9A-9B and associated text thereof. The physical separation of the fluid hub 130 and the mechanical and electrical connectors 320 and 310 also provide additional assurance against accidental contamination from fluid hub 130 to the re-usable portion 102. For further details regarding the physical separation and associated benefits, see said application published as US 2017-0188795 A1 .

[0054] FIGs. 4A. 4B and 4C are a side view, perspective view and cross section of a cannula used on a handheld surgical endoscope, according to some embodiments. The cannula 120 can be extruded and made of a nylon material such as nylon 12 (e.g. Grilamid® L25). The distal end of cannula 120 can include a bent region 122 which is beneficial for certain applications and can effectively increase the field of view of the camera fixed to the distal tip when the endoscope is rotated about its central longitudinal axis. FIGs. 4B and 4C show a further detail of the internal lumina of cannula 120. An insulated electrical cable (not shown in FIGs. 4A-4C) is run though the upper lumen 430. For further details of the insulated cable, which includes conductors used for sending power to the camera and LEDs in the distal tip and signals back to electronics in the handle, see said application published as US 2017-0188795 A1 , e.g., FIGs. 8A and 8B thereof. Fluid lumina 416 and 418 are used to carry fluid between fluid port 132 (shown in FIGs. 1 -3) and the distal fluid ports (see ports 616 and 618 shown in FIG. 6A). In

14 th is example, lumina 416 and 418 each have a cross sectional area of about 1 .33 mm². The needle 1 14 (shown in FIGs. 1 -3, 6A-B and 8A-B) passes through lumen 470. Dimensions are shown in FIG. 4C for an example device. In general, the lumen 470 should be dimensioned to allow passage of the needle 1 14 which according to some embodiments is between 26 gauge (0.4636 mm) and 21 gauge (0.8192 mm). According to some embodiments the needle 1 14 is 23 gauge (0.6414 mm) or 22 gauge (0.7176 mm). According to some embodiments, the cannula 120 can be made such that its stiffness is not constant along its length. For example, it may be useful in some clinical applications to provide a cannula that is more flexible towards the distal tip and stiffer towards the handle. In such cases the cannula 120 can be made from a multi-durometer tubing such as a multi- duro Pebax® or Grilamid®.

[0055] According to some embodiments, cannula 120 is rotatable relative to the handle. The rotation mechanism can be provided in hub 130; further details of the rotation mechanism are shown and described in said application published as US 2017-0188795 A1 .

[0056] FIGs. 5A and 5B are perspective views showing aspects of needle actuation for a handheld surgical endoscope, according to some embodiments. FIG. 5A shows the needle actuation hub 170 when the needle is in the retracted position while FIG. 5B shows the hub 170 when the needle is in the extended position. Hub 170 includes an outer housing 500 through which are formed two windows, proximal window 532 and distal window 534. A lock release button 530 extends from the housing 500 and includes a inwardly protruding tab that aligns with distal window 534. Actuation tab 510 is moveable relative to the hub housing 500. Moving with tab 510 is fluid port 512 that is in fluid communication with fluid line 172 (not shown), spring tab 520 and needle 1 14 (not shown). Further detail of the movable portions of hub 170 is shown in FIG. 7B.

[0057] FIGs. 6A and 6B are perspective views of distal tip 1 12 and show aspects of the needle actuation, according to some embodiments. FIG. 6A shows tip 1 12 when the needle 1 14 in the retracted position while FIG. 6B shows tip 1 12 when the needle 1 14 is in the extended position. Note that while in the retracted position, the sharp tip of needle 1 14 is fully recessed within needle port 614 of tip assembly 1 10 and there is no risk a sharps injury from the tip of needle 1 14. Also

15 visible in FIGs. 6A and 6B are camera lens dust cover 612, two light-guide lenses 662 and 664 (for LED light sources) and distal fluid ports 616 and 618. The distal fluid ports 616 and 618 are provided to allow for fluid communication with fluid lumina 410 and 412 of cannula 120 (shown in FIGs. 4B and 4C). In this example, each of the fluid ports 616 and 618 have a cross sectional area of about 1 .6 mm². Note that port 132, lumina 410 and 412 and distal fluid ports 616 and 618 can be configured to provide fluid in-flow (i.e. flowing fluid out of the endoscope and into the patient's organ or cavity) and/or fluid out-flow (i.e. flowing fluid out of the patient's organ or cavity and into the endoscope).

[0058] FIG. 7A and 7B are perspective views of parts of the single use portion of a handheld surgical endoscope, according to some embodiments. FIG. 7A shows the needle actuation hub 170 from another perspective in which the needle extension markings 710 and 712 are visible. In this example, marking 710 is a "0" indicating to the operator that the needle is fully retracted when spring tab 520 protrudes through proximal window 532, and marking 712 is a "15" indicating that the needle is extended by 15 mm when tab 520 protrudes through distal window 534. According to some embodiments, the full extension of the needle can be amounts other than 15 mm (such as values between 10 and 20 mm) and the marking 712 will reflect that value. FIG. 7B shows carrier 720 which is fixedly attached to actuation tab 510, spring tab 510 and needle 1 14. According to some embodiments carrier 720, spring tab 520 and/or actuation tab 510 are molded from a single piece of polymer material. As shown, spring tab 520 has ramp shaped distal edge and square shaped proximal edge. This shape allows for it move freely distally but will "lock" when it reaches full extension and protrudes through the distal window of housing 500. Needle 1 14 is glued or bonded into an opening of carrier 720. A fluid-tight pathway is provided through carrier 720 between fluid port 512 and the inner lumen of needle 1 14.

[0059] Referring back to FIG. 5A, the actuation tab 510 is shown in the retracted position where tab 510 it is in its most rearward or proximal position relative to the hub housing 500. In this position, spring tab 520 protrudes through proximal window 532 of housing 500 and the tip of needle 1 14 is recessed within the needle port 614 as shown in FIG. 6A. In order to extend the tip of needle 1 14 so as to penetrate a patient's tissue, the operator moves actuation tab 510 forward

16 (distally) relative to the housing 500 as shown by the dotted arrow in FIG. 5A. This causes the carrier 720 (shown in FIG. 7B) to move distally relative to the housing 500, and needle 1 14 to translate distally within lumen 470 (shown in FIGs. 4B and 4c) of cannula 120 and distally relative to tip assembly 1 10. As shown in FIG. 7B, spring tab 520 is movable radially and has ramp shaped distal edge and square shaped proximal edge. Therefore the spring tab 520 is pushed inwards radially by the proximal edge of the proximal window 532. As the actuation tab 510 is pushed further distally, the top surface of tab 520 moves across the inner surface of housing 500 and towards distal window 534. When the spring tab 520 reaches the distal window 534 the radial spring force pushes the tip of tab 520 through the distal window 534. The square shaped proximal edge of spring tab 520 engages the square shaped proximal edge of window 534 which effectively "locks" or prevents retraction or proximal movement of needle 1 14, carrier 720 and actuation tab 510. This locking mechanism is useful when using the needle to inject the desired fluid (such as a drug) into the patient's tissue since the entire endoscope can be used to push the needle without the needle retracting back into the cannula. The surgical endoscope with its needle in a fully extended state is depicted in FIGs. 5B and 6B.

[0060] When the operator wishes to retract the needle, the lock release button 530 is depressed which forces the spring tab 520 inwards though the window 534. In the depressed state, the spring tab 520 is no longer "locked" by the distal window 534 and the actuation tab 510 can then be moved rearwards or proximally relative to the housing 500 which caused the needle to retract back within the tip assembly 1 10 such as shown in FIG. 6A. According to some embodiments, the spring tab 520 can be shaped with square edges on both proximal and distal sides which will allow for the needle to be releasably locked in both the retracted and protruding positions. In such cases the lock release button 530 is used to unlock the tab 520 in either position to allow actuation of the needle.

[0061] FIGs. 8A and 8B are side and cross section views of the distal tip of a handheld surgical endoscope, according to some embodiments. The cannula 120 and housing 81 1 of cannula tip 1 10 are held together using a sleeve 820 that is dimensioned to fit around both the outer surface of the distal end of cannula 120 and the proximal end 816 of tip housing 81 1 . Tip housing 81 1 includes an upper

17 cavity 830 which houses the camera assembly 854 and LEDs 860. A separate needle cavity 870 is included in tip housing 81 1 to allow passage of the needle 1 14. In the example shown the needle 1 14 protrudes 15 mm when fully extended, which has been found to be suitable extension amount for many surgical urology applications. According to some other embodiments, other extension amounts such as between 10 and 20 mm can be implemented. According to some embodiments, the needle 1 14 is not parallel to the center axis of the distal tip assembly 1 10 and housing 81 1 . Rather the needle 1 14 is angled at about 2-5 degrees upwards (towards the camera), so that when the needle 1 14 is in fully protruded position (by 10~20mm, preferably by 15mm), its distal tip will roughly reach the center of the FOV of the camera. This can be accomplished by appropriate shaping of the needle cavity 870 in housing 81 1 . According to some embodiments, sleeve 820 is made of stainless steel, although other material can be used. The three pieces, cannula 120, sleeve 820 and tip housing 81 1 can be glued together using, for example, a U-V cured bonding glue. For further details of the tip assembly 1 10 including suitable sensor, lens and LED components, as well as suitable assembly and bonding techniques, see the co-pending '858 application. According to some embodiments, the field of view (FOV) of the camera is configured such that when extended the tip of needle 1 14 is plainly and clearly visible by the sensor and can be displayed as such to the operator. According to some embodiments, the maximum outer diameter of the tip housing 81 1 is about 15fr (or 5 mm) or less, and the other diameter of the cannula 120 is about 4.8 mm or less. This is in contrast to conventional rigid endoscopes which often have a outer diameter of about 7 mm. According to some embodiments, the distal outer edge of tip housing 81 1 is rounded to facilitate insertion in/though tissue passages and alleviate tissue contact issues. For further details of suitable rounding dimensions and criteria see said application published as US 2017-0188795 A1 .

[0062] FIG. 9 is a perspective view of a handheld surgical endoscope being used to perform a surgical procedure by a single operator, according to some embodiments. Unlike conventional endoscopic surgical procedures that are performed using at least two skilled operators or clinicians, according to some embodiments, the surgical endoscope 100 with an integrated needle is configured for a single operator to perform many surgical procedures. Shown in FIG. 9 is a

18 single operator, with his/her left hand 910 grasping the handle 140 (and optionally press the image capture button 160) and his/her right hand 912 operating the syringe 180 to dispense the drug (or other fluid) via the extended needle 1 14. The patient and patient's tissues are not shown for purposes of clarity. By integrating the needle assembly with the handheld endoscope with attached display as shown and described herein, it has been found that a single operator can both control endoscope and perform the jabbing with the needle (using the entire endoscope) and administering the drug fluid in the syringe. Although FIG. 9 is shown with the left hand operating handle of endoscope 100 and right hand operating the syringe, the operator could easily perform the procedure with his/her hands switched if desired, i.e., right hand operating the handle and left hand operating the syringe.

[0063] FIGs. 10A and 10B are further perspective views of a handheld surgical endoscope being used to perform a surgical procedure by a single operator, according to some embodiments. It has been found that for some procedures, an operator may prefer to manipulate the cannula 120 with one hand while using the other hand to grasp the handle. FIGs. 10A and 10B illustrate how this can be performed by a single operator to both manipulate the endoscope and control the syringe for administering the drug. In particular, the operator uses his/her left hand 910 to grasp the handle and optionally press the capture button 160, and his/her right hand 912 to manipulate the cannula 120 (shown in FIG. 10A) and administer the drug from syringe 180 (shown in FIG. 10B).

[0064] FIG. 1 1 is a perspective view of a handheld surgical endoscope, according to some embodiments. As shown, when needle 1 1 14 is in the extended position, the camera sensor captures a distal portion of the needle and the display 150 show the needle tip clearly in approximately the central portion of the display screen. As is also apparent in FIG. 1 1 , the handheld surgical endoscope 100 is economically configured to a single operator to view the endoscope, the display screen and the syringe, which further facilitates carrying out surgical procedures with a single operator.

[0065] FIG. 12 is a block diagram showing aspects of single operator carrying out a surgical procedure with a handheld surgical endoscope, according to some embodiments. In block 1210, the sterilized packaging containing the single use portion of the endoscope is opened. As shown in FIGs. 1 -3, the single use portion

19 104 includes the fluid hub 130, cannula 120, tip assembly 1 10, the needle actuation hub 170 and fluid line 172. The needle 1 14 is pre-installed in a dedicated lumen in cannula 120 in the recessed (not-extended) position so as to reduce risk of a sharps injury. In block 1212, the single use portion from the sterilized package is mated with the multiple use portion. As shown in FIGs. 1 -3, the multiple use portion 102 includes the handle 140 and the display module 150. In block 1214 a saline solution supply, such as from a syringe is attached to fluid port 132, and the syringe 180 containing the pharmaceutical is connected to fluid line 172.

[0066] In block 1216, a single operator inserts the distal tip 1 12 and cannula 120 through the patient's urethra such that the distal tip 1 12 is deployed in the patient's bladder. Note that the saline (or other fluid) supply attached to fluid port 132 can be used in facilitating insertion of the distal tip as is known. Once the cannula tip 1 12 is in the bladder, the operator can view the bladder cavity and associated tissue on the display module 150 using the camera and LED light sources in the tip 1 12. In 1218 the needle is actuated from "retracted" to the "extended" position by manipulating the actuation tab 510 (shown in FIGs. 5A and 5B) until the sliding mechanism is distally locked. The extended distal tip of the needle 1 14 is in or near the center of the field of view of the camera module and the operator has a good view of the needle tip on the display module as shown in FIG. 1 1 . In block 1220, the distal end of needle 1 14 is inserted or jabbed into the bladder tissue by a distal motion or jabbing of the entire endoscope 100. This is in contrast to procedures using a conventional rigid or flexible endoscope wherein the needle assembly is moved relative to the endoscope for each jab. The

pharmaceutical liquid in syringe 180 is dispensed into the tissue. According to some embodiments, the pharmaceutical liquid is or contains botulinum toxin (Botox). In block 1222 the process of jabbing and dispensing is repeated to treat as much of the bladder tissue as desired by the operator. In block 1224, the needle is retracted by depressing the lock release button 530 and moving the actuation tab 510 proximally. The needle is thereby retracted back into a recessed position within the tip assembly 1 10 of tip 1 12. In block 1226, the cannula and distal tip are withdrawn from the patient's bladder and urethra. In block 1228 single use and multiple use portions of the endoscope 100 are separated from each

20 other. The single use portion can be disposed of and the multiple use portion can be disinfected.

[0067] According to some embodiments, the portions of the endoscope that may be come in contact with a patient's tissue, such as the distal portion of cannula 120 and the tip assembly 1 10, are hydrophilic. For further detail relating to hydrophilic treatments, see said application published as US 2017-0188795 A1 .

[0068] FIGs. 13 and 14 are perspective views of a handheld surgical endoscope having a clip or similar arrangement for attaching the syringe to the handle, according to some embodiments. In these examples, the syringe 180 can be temporarily attached to the handle 140 using a clip or band, which has been found to facilitate performance of the surgical procedure by a single operator in some applications. In the case of FIG. 13, a clip system 1300 is provided that includes a band 1310 to hold syringe 180 and a band 1312 which attaches to the body of handle 140. The two bands 1310 and 1312 can be fixed to each other in the orientation shown such that the syringe 180 is firmly affixed to the handle. With the clip system 1300 installed, the operator can easily use a single hand 912 to grasp the handle 140 and operate its controls (such as image capture button 160) as well as push a plunger of syringe 180. According to some embodiments, the bands 1310 and 1312 are made of a plastic material and according to other embodiments, one or both are made of elastic or rubber-like material. In the case one or both 1310 and 1312 are made of a hard or semi-hard plastic, one or both of the clips can have an opening to facilitate attachment to the handle and/or syringe. Bands 1310 and 1312 can be attached to handle 140 as a unit so that syringe 180 can be slipped in band 1310 and coupled with fluid port 174 via conduit 172 (see Fig. 1 ). As an alternative, band 1312 can be wrapped around or otherwise attached to handle 140, band 1310 can be wrapped around or otherwise attached to syringe 180, or syringe 180 can be slipped into band 1310, and bands 1310 and 1312 can then be secured to each other, for example by one or more buttons on one that snap-fit into depressions in the other, or by matching hook-and-loop (e.g., Velcro) patches secured, for example by gluing, to each band at appropriate positions. As yet another alternative, a hook-and-loop band can be wrapped around each of syringe 180 and handle 140, and the two bands can then be pressed to each other for a hook-and-loop connection. In this manner, a new syringe can be used for

21 each new patient, or two or more syringes can be used in succession for a single patient, and the syringe can be securely attached to the handle such that the user can operate the syringe and the handle with a single hand (and still has the option to push the syringe plunger with the other hand as needed or desired). Syringe 180 can be attached to the left or the right side of handle 140, and can be tilted at a desired angle relative to the long axis of cannula 120.

[0069] FIG. 14 shows another example of a clip system or a similar

arrangement for attaching syringe 180 to handle 140. In this case attachment system 1400 includes bands 1410 and 1412 (similar to bands 1310 and 1312) to attach the syringe 180 to handle 140. In the illustrated example, system 1400 is configured to locate the syringe 180 on the right side of handle 140 and also such that the plunger of syringe 180 is tilted slightly upwards as shown. Various other configurations and relative orientations of the positioning of the syringe 180 and the handle 140 are possible and should be implemented depending upon operator ergonomics and preferences for facilitating the particular surgical procedure by a single operator.

[0070] FIG. 15 is a block diagram of electronic components in the single-use and in the re-usable portions of an endoscope that can be any of the endoscope embodiments discussed in this patent specification. The components in one embodiment are in three group: (1 ) a first group is at the tip of cannula 120; (2) a second group is in a main board 1500 that typically is in handle portion 140; and (3) a third group is in display module 150.

[0071] The group of components at the tip of cannula 120 comprises a camera module 854 that preferably is sufficiently small to fit in a portion of the lumen such as the upper lumen 430, the largest dimension of which is 2.8 mm in one example of cannula 120. Preferably, the largest dimension of camera module across the length of cannula 120 is less than 2.8 mm, and preferably is even less. Camera module 854 can be, for example, the camera module offered by the OPCOM Group of Taiwan under the designation CI362. Notably, camera module 854 preferably comprises a digital rather than analog camera, with on-board analog-to- digital conversion, so that its output is a digital signal in a selected format such as a format conforming to the MIPI format specified by MIPI Alliance, Inc. An example of a suitable format is MIPI Camera Serial Interface 2 (MIPI CSI-2), which is a widely

22 adopted, high-speed protocol useful for point-to-point image and video

transmission between cameras and host devices. Wires in cannula 120 supply the MIDI format output of camera module 854 to the electrical connectors 310, 312 and thus to main board 1500. One or more LED light sources also are included at the tip of cannula 120.

[0072] Main board 1500 serves to interface, process the data, and control the components at the tip of cannula 120 and display module 150. In broad terms, main board 1500 supplies power and control signals to camera module 854 and LEDs 860 as well as to display module 150, and converts the camera MIDI format output to an image signal for display on display module 150. In main board 1500, digital signal processor (DSP) is the main processor that controls the operation of the components at the tip of cannula 120 and in display module 150 and process all the captured data. Communicating through field programmable gate array 1 (FPGA1 ) 1504, DSP 1502 sends a control signal ALC to LED-DRIVER 1506 to turn LEDs 860 ON and OFF and adjust to desired illumination level as needed, and receives the output of camera module 854 after it has been converted from serial to parallel by a STMIPI interface 1508. DSP 1502 exchanges information as needed with information storage devices such as DDR2 memory 1510, SD-CARD memory 1512, and SPI-FLASH memory 1514. DSP 1502 can provide an output to HDMI connector 1516 and can receive key actuation or interrupt signals from touch keys 1518, which can be buttons on handle 140 such as buttons 160 and 162. DSP 1502 also receives touch or swipe information from touch panel 1520 in display panel 150. DSP 1500 provides control signals over I2C line 1522 to camera module 854, touch panel 1520, and FPGA1 1504. DSP 1502 converts the parallel signal from FPAG1 1504 to a serial RGB signal and supplies the serial RGB signal to display module 150.

[0073] Display module 150 displays images from camera module 854 and responds to touch to send control signals to DSP 1502. Display module 150 comprises a field programmable gate array (FPGA2) 1522 that receives images from camera module 854 that are provided from DSP 1502 in serial RGB format. FPGA2 1522 sends the images, in parallel RGB format, to LCD display screen 1526, and can store selected images in memory SRAM 1524 and recall them for display or for storage in SD-CARD 1512 and/or SPI-FLASH 1514, in response to

23 commands from touch panel 1520 or preprogrammed instructions from DSP 1502 or FPGA2 1522 or other processor or memory components. Touch panel 1520 communicates with DSP 1502 over signal bus I2C and also can send commands to DSP 1502 over a direct bus INT. A microcontroller unit MCU 1528 initializes LCD display 1526 as needed and illustrated. Power supply facilities such as a connection to a rechargeable battery removably secured to or in handle 140, a connection to a manual OFF/ON switch on handle 140, and to a camera control button on handle 140 also can be on main board 1500.

[0074] FIG. 16 illustrates overall system flow through electronics illustrated in FIG. 15. User interface module 1602 interacts with the user through touch panel 1520, LCD display 1526, and the manual buttons on handle 140, and interacts with an application programming interface 1604. When the endoscope is powered by operating OFF/ON switch 162, DSP 1502 reads firmware in SPI-FLASH 1514 and initiates STMIPI interface 1508, camera module 854, touch panel 1520 and other components of FIG. 15 as needed. Following initiation, application programming interface 1604 directs the indicated tasks (global, capture, playback and

encode/decode), responding to commands entered through touch panel 1520 and control button 160 on handle 140, utilizing the indicated subsystem library modules 1606 and driver library modules1608, which in turn interact with the electronic components 1610 that are the same as the like-named components in FIG. 15.

[0075] FIG. 17 illustrates an endoscope that can be otherwise the same as illustrated in other embodiments described in this patent specification, for example as shown in FIG. 9, but is provided with plural cannulas 120 that differ in cannula working length (CWL). In one example, cannulas with two CWL can be provided: a shorter cannula with CWL of 8 inches or less, suitable for bladder inspection mainly of female patients, and a longer cannula with CWL of 13 inches or more, suitable for bladder inspection mainly of male patents. Of course, these lengths are only examples, and different lengths can be provided for different medical applications, and three or more different CWL can be provided. An important benefit of providing cannulas with plural CWLs is that each CWL can be optimized for a respective medical application, and a medical facility such as an office, clinic, or hospital can stock as many different CWL cannulas as appropriate for its practice and can use for a given patient procedure the cannula that is best suited for that procedure. For

24 example, in cystoscopy an optimal CWL may be about 8 inches for most female patients but a much greater CWL may present problems such as undesirable bending and twisting of the cannula during insertion and during visualization of the bladder. As another example, for male patient cystoscopy a CWL that is too low may not be sufficient to reach the bladder. For medical applications other than cystoscopy, other CWLs may be appropriate, such as in the range of 8-13 inches, more specifically the range of 10-12 inches, the range of 1 1 -12 inches, or about 1 1 inches. As illustrated, CWL is measured from where cannula 120 emerges from fluid hub and connection assembly 130 to the distal tip of cannula 120. In the case of greater CWLs, a guide wire can be inserted or added to cannula 120, for example in fluid channel(s) or lumen(s) in cannula 120, or through a dedicated additional channel or lumen, or can be integrated or attached to a wall of cannula 120.

[0076] FIG. 18 illustrates an endoscope that can be otherwise the same as illustrated in other embodiments described in this patent specification, such as shown in FIG. 9, but has a rigid or semi-rigid cannula 120a. The term rigid in this context denotes a rigidity that keeps cannula 120a from bending noticeably when being inserted and used in a patient's body, and the term semi-rigid denotes lesser rigidity that allows some bending to help avoid injuries or perforation but not enough to interfere with the medical procedure in which the endoscope is used. Cannula 120a can be straight, as seen in FIG. 18, or it can be provided with a curved tip or with curvature along some or all of its length, as desirable for respective medical procedures.

[0077] FIGs. 19A-19E illustrate an endoscope that can be otherwise the same as in other embodiments described in this patent specification but can be configured with a selected direction of view (DOV) of camera module 854. For example, FIG. 19B illustrates a DOV of zero degrees, i.e., the direction of view is along the long axis 1910 of the cannula tip 1 10, or of the entire cannula if the cannula tip is not angled relative to the rest of the cannula 120. The illustrated DOVs can be for cannulas that are semi-rigid or more flexible. FIGs. 19A-19E further illustrate that different DOVs can be selected for different cannulas 120, 120a, such as an angle of 30 degrees (FIG. 19C), 45 degrees (FIG. 19D), or 70 degrees (Fig. 19E). In the case of DOVs at greater angles to the cannula tip length,

25 the camera can be at a side of the cannula tip, such as illustrated for camera module 854 in FIG. 19E. The illustrated angles are only examples, and different angles can be selected for respective cannulas depending on the medical procedure to be performed or the preference of the health professional carrying out the medical procedure. A desired DOV can be selected when manufacturing the cannula tip, for example by affixing the camera module at a desired orientation of its viewing plane relative to the tip axis, e.g. at a side or a slanted surface of the camera tip, or by bending the cannula such that its tip points in a desired direction, as in Fig. 17 for example. As one alternative, the cannula bending portion 122 (FIG. 1 ) can be made of a material of a known type that can be bent by hand to a desired angle and retain its shape once bent.

[0078] FIG. 20 illustrates an endoscope that can be otherwise the same as in other embodiments described in this patent specification but can be configured with direction of view (DOV) of camera module 854 that allows imaging of tissue that is behind (proximal) of the cannula tip 1 10. According to some embodiments, the camera module 854 can be mounted at the side of the cannula tip 1 10 and can be tilted to have an DOV greater than 90° relative to the tip axis 1910. In general, the camera module 854 can be mounted such that the camera field of view (FOV) and the LED(s) field of illumination (FOI) can at least partly include the the proximal direction of the endoscope 100 and cannula 120. Note that in the case of FIG. 20, the tip 1 10 is angled relative to the main cannula axis 2010, and the camera FOV and the LED(s) FOI partially include directions proximal to the cannula 120. Again, while FIG. 20 illustrates the case of a rigid or semi-rigid cannula (but with an angled tip), the cannula can be more flexible and can include a guide wire if desired.

[0079] The field of view (FOV) of camera module 854 can be a particularly important factor in endoscopes that have a disposable distal portion. A wide FOV (greater than 120°) is desirable because it allows viewing a greater area of an internal organ at one time and thus requires less movement of the cannula during a patient examination, and thus can reduce patient discomfort and examination time. Additionally, a wider FOV can enhance the medical benefits of an examination because it can facilitate readily comparing a suspected abnormality with more surrounding tissue in the same image. However, a small diameter of the cannula and its tip also are important, particularly for bladder endoscopes but also for some

26 other medical procedure, and achieving a wider FOV typically has been reserved for non-disposable cameras, where greater manufacturing cost and perhaps greater cannula and tip diameters can be justified. According to some

embodiments, a wide FOV using a lens system of no more than two lenses, with a small overall diameter, is achieved as discussed below.

[0080] FIG. 21 is an exploded diagram showing various components of a distal tip 1 10 used on a handheld endoscope, according to some embodiments. Cannula 120, which can otherwise be like the cannula seen in Figs. 4A-4C, is shown in Fig. 21 with its upper lumen 430 used to carry cable 410. In the example of Fig. 21 , a single lower lumen 420 can convey fluid, instead of having two fluid lumens as in the example of FIG. 4C. Cable 410 emerges from upper lumen 430 and comprises outer insulation layer 431 surrounding a plurality of inner conductors 412. Each of the inner conductors 412 have their own insulation. Although 6 conductors 412 are depicted in this example, other numbers of conductors can be used depending on the needs to of cameral module and LEDs. The cannula 120 and a tip housing 440 are held together using a sleeve 442 that is dimensioned to fit around both the outer surface of the distal end of cannula 120 and the proximal end 444 of tip housing 440. According to some embodiments, sleeve 442 is made of stainless steel, although other material can be used. The three pieces, cannula 120, sleeve 442 and tip housing 440 can be glued together using, for example, a U-V cured bonding glue. Some or all of the conductors 412 are bonded to a printed circuit board (PCB) 450. According to some embodiments, a relatively strong bonding technique, such as solder, is used to attach the conductors 412 to PCB 450. Such strong bonding has a benefit of further reducing risk that the portions of the tip assembly 1 10 become separated from the cannula during a procedure. Sensor 452 is mounted on PCB 450. A holder 454 sits around sensor 452 and a light shield or ferrule 456 further surrounds the lens system and dust cover 458.

[0081] According to some embodiments, plural LEDs 460 are mounted to a horseshoe-shaped (C-clip shaped) LED board 461 that surrounds the distal end of the lens system 458. According to some embodiments, light-guide lenses 462 and 464 are inserted and bonded to recesses in the distal end of tip housing 440.

Although 4 LEDs 460 are shown in FIG. 21 , other numbers of LEDs can be used around the periphery of lens system 458 such as 1 , 2, 3, 4, 5, 6 or more LEDs. By

27 using 4 LEDs, it has been found that a relatively uniform beam pattern can be produced.

[0082] By positioning the LEDs inside the housing 440 instead of flush with the distal surface, the LEDs are in a sense "encapsulated" in that they do not contact the patient tissue and are well sealed from fluid such as saline. It has also been found that the translucent shell provides some useful light dispersion for a widespread illumination either with or without the use of lenses 462 and 464. Also, recessing the LEDs as shown frees up some space on the distal surface. Finally, the assembly process is simplified when locating the LEDs inside the housing 440.

[0083] The components 480 within an upper cavity of tip housing 440 form a camera or imaging module 480. The tip housing 440 can be molded from a transparent material such as polycarbonate but other easy-to-mold materials could be used instead. When assembled, the front of lens system 458 sits flush with the distal end of tip housing 440 at a lens orifice 441 . A lower orifice 443 is provided to allow for fluid communication with lower lumen 420 of cannula 120. Note that port 132 (FIG. 1 ), lumen 420 and orifice 443 can provide fluid in-flow (i.e. flowing fluid out of the endoscope and into the patient's organ or cavity and/or fluid out-flow (i.e. flowing fluid out of the patient's organ or cavity and into the endoscope).

[0084] FIG. 22A is a magnified perspective view of a portion of the components of camera module 480 illustrated in FIG. 21 . LED board 461 is horseshoe-shaped, or shaped as a C-clip, and mounts by snapping over the proximal end of light shield 456, or can be a ring-shaped mount slipped over light-block ring 456. Light shield 456 extends distally from the LEDs and thus serves as a light shield or ferrule that keeps direct light from the LED from reaching the lens system inside holder 454 and sensor 452. Preferably, LEDs 460 are coplanar or nearly coplanar with the distal end of the lens assembly, and comprise a pair of LEDs 460a at one (left) side of light-block ring or sleeve 466 and a pair of LEDs 460b at the other (right) side.

[0085] FIG. 22B is a front view, FIG. 22C is a side view, and FIG. 22D is a sectional view of one example of the distal tip 1 10 of cannula 120. Some dimensions are illustrated but alternative dimensions are possible and

contemplated within the scope of this patent specification. FIGs. 22B-22D show lens orifice 441 , recesses 468 and 470 into which the lenses 462 and 464 are

28 inserted, and a lower orifice 474 through which fluid can pass into or out of the patient or a guide wire can pass. As can be seen from FIG. 22D, the inner part of the tip 1 10 of cannula 120 has two cavities 472 and 474 that are separated by wall 476. FIGs. 22C and 22D show that according to some embodiments the distal outer edge 478 is rounded to facilitate insertion in/though tissue passages and alleviate tissue contact issues. When inserting the endoscope into and through passages such as the urethra, trachea or blood vessels, it is desirable that the outer distal edge 478 of the distal tip should be rounded since that region of the distal tip both contacts and dilates the tissue passage. In such cases, the central portion 480 of the distal tip can be made less rounded or flat. Making the central portion 480 less rounded or flat has been found to enhance imaging characteristics over a more spherical overall tip since the camera and illumination are not impaired or are significantly less impaired. In the case shown, orifice 472 can be covered with a flat glass dust cover that sits flush with the remainder of central portion 480. FIGs. 22C and 22D show that outer surface of housing 482 around fluid or guide wire opening 466 can be tapered. In the example shown an approximately 1 - degree taper has been found to be useful for insertion in urological applications. The tip surface around the fluid or guide wire orifice is beveled, as best seen in FIGs. 4C and 4D.

[0086] In one embodiment, the endoscopes described in this patent specification achieve wide FOV for small cannula tips (less than 5 mm canula tip diameter) and low cost through special technology using a lens system of no more than two miniature lenses that preferable are molded using plastic material.

[0087] Fig. 23 illustrates a section through a lens system 2300 that is inside a lens barrel 2310 that fits in lens holder 454 seen in FIG. 22C and preferably is coaxial with light shield or ferrule 456. Lens barrel 2310 holds two lenses 2312 and 2314, labeled as 1 ^st (top) element 2312 and 2^nd element 2314. The 2^nd lens element 2314 can be held in barrel 2310 by a mounting ring or spacer 2316. The 1 ^st lens element 2312 can be held in barrel 2310 by a ring-shaped iris 2318. An infrared (IR) filter 2316 can be placed just proximally of the 2^nd element 2314. A single lens could be used in place of lenses 2312 and 2314 if it can provide a sufficiently wide FOV to the camera module.

29 [0088] An important property of the lens system 2300 is that it provides sensor 452 with a field of view (FOV) that is uniquely wide for a single-use, disposable endoscope portion with a small outside diameter such as less than 5 mm and preferably 4.2 mm, or 4 mm, or less. In some embodiments, the FOV is more than 120°, preferably is 130° or more, and most preferably is 140° or more at a diagonal of a rectangular or square sensor 452, at a sensor plane 2320 thereof. In a specific example of a lens system 2300 according to some embodiments, for a rectangular sensor 452 the FOV parameters are: diagonal FOV - 140°±3°;

horizontal FOV - 106°±3°; and vertical FOV - 82°±3°. In this example, the total track length of lens assembly 2300, which is the distance from the distal end of 1 ^st lens element 2312 to the sensor plane 2320 of sensor 452, is 4 mm; the distance from the proximal end of IR filter 2316 to the sensor plane 2320 of sensor 452 is 1 .56 mm; and the distance from the proximal end of lens barrel 2310 to the sensor plane 2320 is 1 .2 mm. The outside diameter of lens barrel 2310 is 2 mm in this example. The resolution of the combination of lens system 2300 and sensor 452 (in an example of sensor with 640x480 pixels), in terms of MTF (modulation transfer function), is (1 ) on axis - 50% at 200 Ip/mm (line pairs per mm), and 76% at 100 Ip/mm; and (2) for 80% - 39%(t) and 52%(s) at 100 Ip/mm, and 66%(t) and 74%(s) at 60 Ip/mm in the same example. The distortion is no more than 15% in the same example. Of course, these parameters are for a specific example of some embodiments, and different parameters can be used and are contemplated in this patent specification so long as they achieve the desired FOV greater than 120°, preferably 130° or more, and most preferably140° or more

[0089] The wide field of view of lens system 2310 allows a greater area of the organ being imaged to be seen in a single image than in known prior art disposable endoscopes. This can be particularly important when viewing organs such as the bladder, which has an internal area several times that of the uterus. If a known prior art disposable endoscope with an FOV of 120° is used for viewing the bladder, it would require considerably more repositioning than an endoscope with a wider FOV to examine the same internal area. In addition, the wider FOV allows a greater area of the organ to be seen in a single image, which can facilitate accurate assessment by allowing comparison of one area of the organ relative to other areas in the same image.

30 [0090] As illustrated in FIG. 22A and discussed above, according to some embodiments LEDs 460 are symmetrically arranged around light-block ring 456, in a way that allows the illumination from one side of ring 456 to overlap with that from the other side and thus provide a wide field of illumination (FOI) that substantially match the FOV of sensor 452.

[0091] FIG. 24A illustrates this overlap, where the light from LEDs 460 that are at one lateral side of ring 458 provides a field of illumination labeled LED FOI 1 , the light from LEDs 460 that are at the opposite lateral side of ring 458 provides a field of illumination labeled LED FOI 2, and the two FOIs overlap each other and in addition match the FOV of lens system 2300. While as illustrated the outer edges of the FOI and the FOV may be slightly offset, they still match to make good use of the available light and avoid blind spots.

[0092] In contrast, in a known endoscope the LED light source is not symmetrically arranged relative to the lens system, and there is a substantial mismatch, as illustrated in FIG. 24B, where a substantial portion of the lens FOV is not illuminated and thus there is a blind spot with insufficient light to show well in the image. When referring to a symmetric arrangement of LEDs, this patent specification means a substantially rather than perfectly symmetric arrangement, for example as illustrated in FIG. 22A, where the LEDs are symmetric relative to a vertical section through the central axis of light shield 456 and are nearly but not necessarily perfectly symmetric relative to a horizontal section through the central axis.

[0093] According to some embodiments, images are improved by providing the endoscope with facilities to make illumination of the camera FOV more uniform. This is particularly beneficial for examining organs such as the internal wall of the bladder, where cannula tip 1 10 may be in a position in which one pair of adjacent LEDs is significantly closer to the bladder wall than the other pair. In that situation, one side of sensor 452 may receive significantly more light than the other, and the image may be unbalanced in brightness. This can make image interpretation more difficult as some of the imaged portion of the bladder wall may appear darker than another portion or one portion may appear lighter or even washed out. FIG. 24C illustrates an image where the field of view of the camera is not uniformly illuminated, and as a result an image region 2410 is darker overall because it has

31 received less light than image region 2412. This can occur because of a significant mismatch between the FOI and the FOV due to an arrangement such as seen in FIG. 24B. It has been found that uneven overall brightness of areas within an image can occur to a lesser extent for a different reason as well - because some of the LEDs are significantly closer to the organ surface being imaged than other LEDs even when the LEDs are symmetrically arranged around the optical axis of the lens system. Control over brightness, as discussed below, therefore can help even where the LEDs are symmetrically arranged.

[0094] FIG. 25 shows in block diagram form an example of a control circuit or system that can improve brightness balance in the image when different area of the organ being imaged receive different levels of illumination. This control circuit can be used in any of the endoscopes described in this patent specification. FIG. 25 is similar to FIG. 15 in U.S. patent application SN 15/651 ,526, incorporated by reference, except for additions and changes that deal with improving brightness balance. Specifically, LEDs 460a at one side of light-shield ring 456 of camera module 480 have their own LED driver 2506a and LEDs 460b at the other side of the light-shield ring have their own LED driver 2506b. Field programmable gate array 2508 provides respective control signals ALCa and ALCb to LED drivers 2506a and 2506b that vary the intensity of light the LEDs put out. A 3-position, manually operated switch or button 2512 provides input to processor ISP 2510, which through FPGA 708 varies the control signals ALCa and ALCb and thus the light intensity from LEDs 460a and 460b. As one example, (i) in position 1 of switch 2512, which can be the default position, LEDs 460a and 460b provide roughly equal light intensities, e.g., each operates at 100% of its rated brightness; (ii) in position 2, LEDs 460a operate at 50% of their rated brightness while LEDs 460b operate at 100% brightness, and (iii) in position 3, LEDs 460a operate at 100% brightness while LEDs 460b operate at 50% brightness. Of course, different brightness levels can be implemented for the dimmed LEDs, such as 40%, 60%, 70%, etc. And, there can be more than two individually controlled groups of LEDs, such as 3 or 4 groups, with a corresponding switch having more positions that vary the light outputs of the LEDs. A potentiometer rather than a 3-position switch can be used to make the steps in relative light output of the LEDs even finer. Switch or button 712 can be mounted at a convenient position on handle 140, for example as

32 illustrated in FIG. 1 , to be operated by the user. While display 150 shows an image and the user is manipulating handle 140 to point cannula 120 to different areas of the organ being examined, the user can operate switch 2512 depending on the brightness balance seen on display 150.

[0095] In other respects, FIG. 25 is like FIG. 15 in said application SN

15/651 ,526, and will be similarly described below except for the use of different reference numerals. A main board 2516 serves to interface, process the data, and control the components at the tip of cannula 120 and display module 150. In broad terms, main board 2516 supplies power and control signals to camera module 480 and LEDs 460 as well as to display module 150, and converts the camera output to an image signal for display on display module 150. In main board 2516, processor 2510 (which can be a DSP or ISP) digital signal processor, controls the operation of the components at the tip of cannula 120 and in display module 150 and processes the captured image data. Communicating through field programmable gate array (FPGA1 ) 2508, processor 2510 sends control signals ALCa and ALCb to LED-DRIVERs 2506a and 2506b, respectively, to turn LEDs 460a and 460b ON and OFF and to adjust their outputs to the desired brightness levels as needed. Processor 2510 receives the output of camera module 480 after it has been converted from serial to parallel by a STMIPI interface 2518. Processor 2510 exchanges information as needed with information storage devices such as DDR2 memory 2520, SD-CARD memory 2522, and SPI-FLASH memory 2524. In one illustrative example, the positions of switch 2512 result in illumination as stated in Fig. 25: the default brightness can be equal or normal illumination from the two pairs of LEDs; LEDs left at 50% illumination and LEDs right at normal illumination; and LEDs right at 50% illumination and LEDs left at normal illumination. Processor 2510 can provide an output to HDMI connector 2514 and can receive key actuation or interrupt signals from touch keys 2526, which can be buttons on handle 140 such as buttons 160 and 162. Processor 2510 also receives touch or swipe information from touch panel 2528 in display 150. Processor 2510 provides control signals over I2C line 2530 to cameral module 480, touch panel 2528, and FPGA1 2508. Processor 2510 converts the parallel signal from FPAG1 2508 to a serial RGB signal and supplies the serial RGB signal to display module 150.

33 [0096] Display module 150 displays images from camera module 480 and responds to touch to send control signals to processor 2510. Display module 150 comprises a field programmable gate array (FPGA2) 2532 that receives images from camera module 480 that are provided through processor 2510 in serial RGB format. FPGA2 2532 sends the images, in parallel RGB format, to LCD display screen 2534, and can store selected images in memory SRAM 2536 and recall them for display or for storage in SD-CARD 2522 and/or SPI-FLASH 2524, in response to commands from touch panel 2528 or preprogrammed instructions from processor 2510 or FPGA2 2532 or other processor or memory components. Touch panel 2528 communicates with processor 2510 over signal bus I2C 2530 and can send commands to processor 2510 over a direct bus INT 2538. Power supply facilities such as a connection to a rechargeable battery removably secured to handle 140, a connection to a manual OFF/ON switch on handle 140, and to a camera control button on handle 140 also can be on main board 2516.

[0097] Thus, in the example of Fig. 25, the user can select one of the three positions of switch or button 2512 to reduce brightness imbalance in the image as needed.

[0098] According to some embodiments, an automated system can be implemented in any of the described endoscopes to improve brightness balance in the image, in smoother steps if desired. FIG. 26 illustrates such an automated system, and is otherwise similar to FIG. 25 except that it omits switch 2512 and includes an algorithm in processor 2510 that responds to the level of overall brightness in selected areas of the image information from sensor 452 (or from LCD display 2534) to change the light outputs of LEDs 460 toward equalizing the overall brightness over the entire image on LCD display 2534. In this example, processor 2510 is programmed with an algorithm 2510a that responds to a difference in the overall brightness of two different areas of the current image frame from sensor 452, for example to a difference between the overall brightness of the left half of the image frame and the right half. The algorithm can be relatively simple - e.g., when either of the left half or the right half of the image frame exceeds a selected threshold of overall brightness, processor 2510 calculates a balance signal indicative or the difference and issues commands to LED driver 2506a and/or 2506b to reduce the intensity of the LEDs that correspond to the side

34 of the image that had has overall brightness over the threshold. In a simple implementation, algorithm 2510a can mimic the effect of switch 2512 of FIG. 25, i.e., (i) when the left side of the image frame is more than a threshold brighter than the right side, reduce the light output of the left LEDs 460a by 50% (or some other selected % reduction), (ii) do the opposite if the right side of the image has overall brightness over a threshold, and (iii) do not change the relative outputs of the LEDs is the difference in overall brightness of the left and right sides of the image frame is within a selected threshold. Alternatively, algorithm 2510a can provide control in finer steps, e.g., if the difference in overall brightness between the two halves of the image frame is more than a first threshold but less than a second threshold, decrease the light output of the relevant LEDs by a first amount; but if the difference is more than a second, greater threshold, decrease by a second, greater amount. There can be even more steps, i.e. three or more thresholds and three or more corresponding decreases in the light output of the relevant LEDs. As an alternative, the algorithm can increase the light output of the LEDs corresponding to the image area that is less bright, with or without concurrent decrease in the light output of the LEDs corresponding to the brighter area in the image. The algorithm can be implemented by a person of ordinary skill in programming given the teachings of this patent specification. Instead of responding to overall brightness or each half of the image frame, algorithm 2510a can be configured to respond to two or more smaller areas of the image, such as two strips of the image frame or two groups of pixels spread in each half of the image, or several groups of pixels in each half of the image.

[0099] The depth to which an injection needle protruding from the tip of an endoscope cannula penetrates into tissue can be important to a medical professional and to a patient. Controlling insertion depth by feel may not be sufficiently accurate and reproducible. For example, where some type of medication are injected into the bladder with an endoscope, there can be multiple injection sites and it may be important to ensure the insertion depth is as needed, e.g., the same for all sites but no deeper or shallower than desires or, conversely, to different desired depths at different sites depending on medical requirements. In endoscopes described in this patent specification, insertion depth can be controlled both accurately and reproducibly, according to some embodiments.

35 [00100] FIG. 27 illustrates an image seen on display screen 150 when injection needle 1 1 14 is in its fully extended position, for example in the position seen in FIG. 6B. As earlier noted, e.g., in connection with FIG. 1 1 , in some embodiments an endoscope is configured such that the needle is seen on display 150 and the needle tip is at central area of the image. In the example of FIG. 27, display 150 is provided with graduation marks 2710 each of which represents a respective depth of insertion of needle 1 1 14 into tissue. The graduation marks can be inscribed on otherwise placed on the screen of display 150, or they may be a part of the displayed image, the control over the display can be programmed so the marks show all the time or only when the user desires turns them on or elects not to turn them off. The insertion depth can be seen on screen 150 overlaid on an image of tissue such as the inside of a patient's bladder, and on the graduation marks. A unit of the graduation marks, such as the distance between two adjacent marks 2710 can be fixed for a particular embodiment of an endoscope - for example, a unit of graduation marks corresponds to 2 mm of needle length or insertion depth. Of course, a different relationship can be established, such as a unit of graduation marks corresponding to 1 mm or 3 mm, etc. In the example of FIG. 27, the distal 6 mm of needle length is seen in the image on display 150.

[00101] FIGs. 28A-28C illustrate images on display 150 at three different depths of insertion of needle 1 14 into tissue, for some embodiments (for clarity, the image of tissue such as an inside bladder wall, is omitted in these figures but in actual practice would be seen under the overlay of the needle image and the graduation marks). FIG. 28A shows needle 1 1 14 at zero insertion depth, i.e., the entire distal portion of the needle is seen as the needle has not yet been inserted in tissue. FIG. 28B shows at 2814 the portion of the needle that has not penetrated tissue, and shows in broken lines at 2916 the needle portion that already has entered tissue and therefore is not visible in the image. The endoscope user thus can verify visually how much of the needle has been inserted and can determine if the desired insertion depth has been reached and/or maintained for a given injection site and, if not, now much deeper to insert the needle or how much to pull back the injection needle. FIG. 28C illustrates what display 150 shows for a deeper insertion. In this case, the portion 2814 of the needle that is seen in the image only goes up to the first graduation mark 2710, which means that a needle length

36 corresponding to the distances between two pairs of adjacent marks has been inserted into tissue. The portion 2016 is not visible in the image, as it is inside tissue, and has been shown in FIG. 28C in broken lines. For example, if the distance between two marks 2710 corresponds to 2 mm of needle length, FIG. 28B shows that 2 mm of needle length has been inserted in tissue and FIG. 28C shows that 4 mm of needle length has been inserted into tissue. At each injection site, display 150 shows dynamically the actual insertion depth as the needle is being inserted. The endoscope user therefore can use the image on display 150 to reliably and reproducibly insert the needle to a desired depth at each injection site.

[00102] FIG. 29 illustrates an example of markings on injection needle 1 14 that can facilitate control over needle insertion depth, in some embodiments of endoscopes described in this patent specification. In this example, the markings comprise three portions of injection needle 1 14 that are colored in respective different colors, for example, red at portion 2912 that is immediately behind needle tip 2910, blue at the next portion 2914, and green for the remaining portion 2916. In this example, each portion is 2 mm long, but of course different lengths in mm can be marked in color, and the portions can all be the same in length or differ in length from each other. The color on the needle are highly visible in the image on display 150 and can speed up the injection procedure while providing immediate guidance of current insertion depth and confirmation that the desired depth has been achieved and maintained during injection or changed during injection as desired. Different colors or a different number of colors can be used, or markings different from color can be used in place of the illustrated colors.

[00103] 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.

37

Claims

What it claimed is: 1 . An endoscope having a multiple-use, reusable proximal portion and a

single-use, disposable distal portion carrying entirely internally a needle movable between a retracted position in which the needle is within the disposable portion and an extended position in which a distal end of the needle protrudes from a distal tip of the disposable portion, said endoscope comprising:

a handle configured to be grasped by the user's hand and having at least one button controlling endoscope functions, and a video display screen mounted to the handle, wherein the handle and the screen form a part of the reusable portion of the endoscope;

a cannula forming a part of the disposable portion of the endoscope;

a connector at a proximal part of the disposable portion of the endoscope, configured to releasably mate tool-free with a connector at the reusable portion of the endoscope thereby releasably integrating the reusable and disposable portions;

a needle actuation tab mounted to the endoscope and positioned and

configured to be moved between a retracted position and an extended position by the user grasping the handle;

said needle actuation tab being coupled to said needle to drive it between its retracted and extended positions as the user moves the tab between its retracted and extended positions;

an injection fluid port at a proximal part of the disposable portion, said port being in fluid communication with the injection needle through the cannula so that fluid introduced in the port is injected through the needle; and

an imaging module with a video camera at said tip of the cannula, coupled with the screen to provide images to the screen, and a light source at the tip of the cannula configured to illuminate a region viewed by the camera, under control of said buttons on the handle.

38 The endoscope of claim 1 , further including a source of fluid and a flexible conduit from the source to the injection fluid port, wherein the flexible conduit is the sole connection between the source of fluid and the endoscope.

The endoscope of claim 1 , further including a syringe releasably secured to the handle and coupled with the fluid port to enable the operator to use a single hand to operate the endoscope to visualize a region of the patient, to move the needle between its retracted and extended positions and jab the needle into tissue, and to inject fluid into the tissue.

The endoscope of claim 1 , in which said imaging module has a field of view (FOV) and the distal tip of the needle is at a central region of the FOV when the needle is in its extended position.

The endoscope of claim 1 in which said imaging module has a direction of view (DOV) that is angled relative to the direction in which the cannula tip extends.

The endoscope of claim 1 , in which said needle actuation tab has a projection moving with the tab, and the endoscope has stops configured to releasably engage the projection at each of the retracted and extended positions of the needle actuation tab and thereby releasably lock the tab at least in its extended position, and the endoscope further includes a hand- operated release button acting on said projection to thereby selectively release the tab and thus the needle from a locked position.

The endoscope of claim 1 , in which said cannula is secured to said disposable portion for selective rotation of the cannula about a long axis thereof.

The endoscope of claim 1 , in which said needle is no longer than the distance from said fluid port to the distal end of the cannula.

39

9. The endoscope of claim 1 , in which said connector comprises a mechanical connector at each of the reusable and disposable portions and an electrical connector at each of the reusable and disposable portions, wherein the electrical connectors are spaced proximally from the mechanical connectors by a distance of 2 cm or more, and said connectors releasably integrate the reusable and disposable portions into said endoscope tool-free.

10. The endoscope of claim 1 , in which said video camera in the imaging

module is a digital camera transmitting digital video images from the cannula distal end to said electrical connectors.

1 1 . The endoscope of claim 1 , in which the cannula tip at said video camera has an outside diameter of 4 mm or less. 12. The endoscope of claim 1 , in which the cannula tip housing said video

camera has an outside diameter of 3 mm or less.

13. The endoscope of claim 1 , in which said imaging module in said disposable portion has a field of view (FOV) of 140° or more.

14. The endoscope of claim 1 , in which said imaging module in said disposable portion has a field of view (FOV) of 130° or more.

15. The endoscope of claim 1 , in which said imaging module comprises an image sensor array, and no more than two lenses providing a field of view

(FOV) of the imaging module of no less than 130°.

16. The endoscope of claim 1 , in which said imaging module comprises an image sensor array having an image plane, and no more than two lenses providing a field of view (FOV) of the imaging module of no less than 130°, wherein the lenses extend no more than 4 mm from said image plane.

17. The endoscope of claim 1 , in which said imaging module comprises an image sensor array, and no more than two lenses providing a field of view (FOV) of the imaging module of no less than 130°, wherein each of

40 said lenses is made of a molded polymer material.

18. The endoscope of claim 1 , wherein said light source comprises plural LEDs arranged symmetrically around a long axis of said cannula and having a field of illumination (FOI) that matches a field of view (FOV) of said imaging module thereby avoiding blind spots or unevenly illuminated FOV.

19. The endoscope of claim 1 , further including a circuit controlling the areal distribution of illumination from said light source to reduce brightness imbalance between portions of images provided by said imaging module.

20. The endoscope of claim 1 , further including hand-operated control on said reusable portions and a circuit responsive to said hand-operated control to vary the distribution of illumination from said light source to reduce brightness imbalance between portions of images provided by said imaging module.

21 . The endoscope of claim 1 , further including a circuit responsive to

imbalance in brightness between areas of said images provided by the imaging module to automatically reduce said imbalance by varying the areal distribution of illumination from said light source.

22. The endoscope of claim 1 , in which of said imaging module has a field of view that includes a distal length of said needle, and said display has markings at a length of the needle visible on the display that show to what depth the needle has been inserted in tissue.

23. The endoscope of claim 1 , in which said imaging module has a field of view that includes a distal length of said needle, and said distal length of the needle has markings that show on said display to what extent the needle has been inserted in tissue.

41

24. The endoscope of claim 1 , in which said imaging module has a field of view that includes a distal length of said needle, and further including markings on both of said display and said needle, which markings show on the display a depth of penetration of the needle in tissue in use of the endoscope.

25. An endoscope having a multiple-use reusable proximal portion and a single- use, disposable distal portion, comprising:

a handle configured to be grasped by the user's hand and having at least one button controlling endoscope functions, and a video display screen mounted to the handle, wherein the handle and the screen form a part of the reusable portion of the endoscope;

a cannula forming a part of the disposable portion of the endoscope;

a connector at a proximal part of the disposable portion of the endoscope, configured to releasably mate tool-free with a connector at the reusable portion of the endoscope thereby releasably integrating the reusable and disposable portions; and

an imaging module with a video camera at a tip of the cannula, coupled with the screen to provide images to the screen, and a light source at the tip of the cannula to illuminate a region viewed by said camera, under the control of said buttons on the handle;

wherein said video camera is a digital camera providing a digital image

output delivered to said video display screen; and

wherein said tip of the cannula has an outside diameter no greater than 4.2 mm and said imaging module comprises an image sensor with an image plane no wider or taller than 3 mm.

26. The endoscope of claim 25, in which said digital camera comprises an

image sensor having an image plane with linear dimensions no greater than 3 mm.

27. The endoscope of claim 25, in which said imaging module comprises a lens system providing a field of view of no less than 130°.

42

28. The endoscope of claim 27, in which said lens system uses no more than two lenses.

29. The endoscope of claim 28, in which said lenses extend no more than 4 mm from said image plane.

30. The endoscope of claim 25, further comprising a needle that is entirely contained in said disposable portion of the endoscope and has an extended position in which it protrudes distally from said cannula, wherein said imaging module has a field of view that includes a distal length of said needle, and further including markings on one or both of said display and said needle, which markings show on the display a depth of penetration of the needle in tissue in use of the endoscope.

31 . An endoscope having a multiple-use, reusable proximal portion and a

single-use, disposable distal portion, comprising:

a handle configured to be grasped by the user's hand and having at least one button controlling endoscope functions, and a video display screen mounted to the handle, wherein the handle and the screen form a part of the reusable portion of the endoscope;

a cannula forming a part of the disposable portion of the endoscope;

a connector at a proximal part of the disposable portion of the endoscope, configured to releasably mate tool-free with a connector at the reusable portion of the endoscope thereby releasably integrating the reusable and disposable portions;

an imaging module with a video camera at a tip of the cannula, coupled with the screen to provide images to the screen, and a light source at the tip of the canula to illuminate a region viewed by the camera, under the control of said buttons on the handle; and

a circuit coupled with said light source and configured to control the areal distribution of illumination from said light source to reduce brightness imbalance between portions of said images.

43

32. The endoscope of claim 31 , further including hand-operated control on said reusable portions, wherein said circuit is responsive to said hand- operated control to vary the distribution of illumination from said light source to thereby reduce brightness imbalance between portions of images shown on said screen.

33. The endoscope of claim 31 , in which said circuit is responsive to

imbalance in brightness between areas of said images provided by the imaging module to automatically reduce said imbalance by varying the areal distribution of illumination from said light source.

34. The endoscope of claim 31 , in which said light source comprises plural LEDs at each of two sides of a long axis of said cannula, and said circuit is configured to vary the illumination from the LEDs on one of said sides relative to the illumination from the other of said sides.

35. A single-use, disposable distal portion configured to releasably mate with a multiple-use reusable proximal portion to thereby form an endoscope, said disposable portion comprising:

a cannula having a connector at a proximal part thereof, configured to

releasably mate tool-free with the reusable portion to thereby releasably integrate the reusable and disposable portions; and an imaging module with a video camera at a tip of the cannula configured to provide images of a region, and a light source at the tip of the cannula to illuminate the region viewed by said camera;

wherein said video camera is a digital camera providing a digital image output for delivery to said reusable portion; and

wherein said tip of the cannula has an outside diameter no greater than 4.2 mm and said imaging module comprises an image sensor with an image plane no wider or taller than 3 mm.

36. The disposable portion of claim 35, further comprising an injection needle carried entirely within said disposable portion and movable between a

44 retracted position in which the needle is within the disposable portion and an extended position in which a distal end of the needle protrudes from a distal tip of the disposable portion.

37. The endoscope of claim 36, in which said imaging module has a field of view of at least 130° that includes a distal length of said needle, and further including markings on one or both of said display and said needle, which markings show on the display a depth of penetration of the needle in tissue in use of the endoscope.

38. The disposable portion of claim 35, in which said imaging module comprises a lens system providing a field of view of no less than 130°.

39. The disposable portion of claim 37 in which said lens system uses no more than two lenses.

40. The endoscope of claim 37, in which said lenses extend no more than 4 mm from said image plane.

45