Small field-of-view endoscope with image orientation correction

Abstract

The rotatable chip-on-tip endoscope is configured to be operated with one hand by grasping the body of the device with the palm and operating the distal rotatable end of the handle that carries the needle with one or two fingers. The needle has a small diameter, preferably less than 2.5 mm at its largest end. When the tip is rotated to view more widely within the patient's joint, for example, the video processing electronic circuit corrects the rotational orientation in real time to present a stable moving image on the monitor.

Description

Technical Field

[0001] This application claims the benefit of Provisional Patent Application No. 63 / 184,700, filed May 5, 2021.

[0002] The present invention relates to surgical endoscopes and the use of endoscopes. In particular, the present invention is directed to improvements in small-diameter rotatable tip-on-tip endoscopes.

Background Art

[0003] During surgery, a spatial misalignment between the visual display space, e.g., a monitor in the operating room, and the physical environment, e.g., the inside of a patient's joint, can lead to a decrease in surgical performance. Such misalignment occurs when using a side-view endoscope.

[0004] Therefore, in order to assist the surgeon in interpreting and reading the images from video endoscopy, automatic or semi-automatic image correction or reorientation according to a predefined axis is desirable.

[0005] Furthermore, it is common practice to use a side-view endoscope during surgery to visualize not only the forward visible area but also specific items that can be located on either side of the image located primarily in the front. Sometimes it is necessary to identify the location of a defect that is only accessible by a side-view imaging system and that is located behind an obstacle on the side of the endoscope tip. Thereby, the need to use a flexible or maneuverable scope that has its own problems is also reduced. Although rotation of the scope is required to fully view the area using a side-view scope, if the rotation includes a sensor (camera), the rotational orientation of the image on the monitor will change.

[0006] Variable viewing directivity in side-view endoscopes has conventionally been achieved primarily through optical elements rotated relative to a fixed imaging sensor or camera. In this case, no rotated image is produced on the monitor.

[0007] A side-view endoscope typically uses a camera mechanically coupled (outside the body) to a lens system necessary to image an object from inside the body onto the camera. Inside the body, however, the side-view lens system can be rotated around the longitudinal axis of the scope. The side-view lens system itself has an optical axis at its distal end, and the optical axis is set at a specific angle relative to the axis of the forward-facing scope, i.e., relative to the longitudinal axis of the scope. In most cases, it is necessary to minimize the size or diameter of the scope in order to access small cavities within the body or to minimize friction or damage to the body that may occur.

[0008] The camera / imaging sensor is held stationary relative to the patient or to a general reference frame in the room. That is, even if the side-view scope is rotated through the optical element to access a viewing direction other than the forward direction, there is no need to correct the image collected in digital form in order to view the image on the video monitor in a particular desired orientation. If the sensor is mounted using its horizontal dimension parallel to the horizon, the rotation of the current side-view scope lens does not affect the orientation of the image on the video monitor, i.e., the "top" of the video monitor is still "top" relative to the patient or body part being examined.

[0009] A particular case of an endoscope is the "chip-on-tip" endoscope where the camera imaging sensor is firmly attached to the lens and both are located at the distal end of the endoscope. See, for example, U.S. Patent No. 10,463,399. The chip-on-tip endoscope can have a flexible body from the proximal end to the distal camera-lens system or can be a rigid structure that attaches to the handle at the proximal end. In the latter case, the handle along with the camera and lens are all integrated and firmly attached to each other.

[0010] For all current background cases of chip-on-tip architectures that include a fixed miniaturized lens system, there are two options. One is a rigid "needle" endoscope where the operator's hand manipulates the tip of the endoscope (by operating a handle to which the tip of the endoscope is rigidly attached), thereby being able to acquire the target at the tip of the endoscope without considering any movement, rotation, or twist of the base or body of the endoscope. Typically, a rigid chip-on-tip endoscope has a short length of about 30.48 cm (1 foot) or less. The other option is a flexible endoscope where the chip-on-tip is at the tip of the scope and, in some cases, a flexible member of a longer length reaching several meters further separates the handle from the tip. This will come to be called a bronchoscope for some other non-health related applications.

[0011] In these current background devices, when tip rotation is required to view a target area in a location that would otherwise be inaccessible, in many cases, it is necessary to correct the orientation of the image in the video monitor and always maintain that image in a specific rotational orientation relative to a specific reference point or horizontal line of the target. For example, if the target is the patient's knee, it is necessary to hold the image in the video monitor so that the horizontal line is maintained. To accomplish that function, some chip-on-tip systems have some form of a rotation sensor and electronic correction of the image orientation.

[0012] First, a small sensor can be combined with a larger and longer variable lens in front of the small sensor, and the variable lens can rotate. In this configuration, the lens extends far beyond the imaging sensor and to the scope length so that it can be rotated relative to the sensor, so this is not a native chip-on-tip. These devices resemble a miniaturized and bulkier side-view rigid scope instead of a chip-on-tip endoscope. Further, a more complex lens system distal to the sensor increases the overall diameter of the scope far beyond the installation space of the underlying sensor, resulting in a much larger diameter configuration. Moreover, such devices are more complex and expensive, invalidating the disposability that is the main purpose of chip-on-tip endoscopes.

[0013] Second, a chip-on-tip scope is integrated with an electronic device (i.e., a tip-mounted electronic gyro) such that it transmits the tip rotation information to a computer, which uses this information to correct the angle of rotation and can then project an image onto a video screen in its corrected upright orientation.

[0014] These devices are complex, and the native orientation information or minimally reliable orientation information cannot be known unless accelerometers and magnetometers are included at the tip. Signals from electronic components, especially those stored or carried by the device before use or before the next use, can drift over time, creating a need for "resetting" or calibration before such use. Further, devices, especially for disposable endoscopes and arthroscopes, are expensive. Moreover, adding electronic sensors near or around the distal tip of the scope increases the diameter of the scope, which is an undesirable result in medical applications where the goal is to create the smallest possible configuration for minimal tissue damage.

Prior Art Documents

Patent Documents

[0015]

Patent Document 1

Patent Document 2

Summary of the Invention

Means for Solving the Problems

[0016] According to the present invention, a chip-on-tip endoscope comprises an imaging lens and an imaging sensor at the distal tip of a small-diameter rigid shaft. The optical axis of the imaging lens may be along the axis of the shaft (zero-degree forward-view scope) or at an acute angle with respect to the axis of the shaft (side-view scope) (for example, 30-degree side-view scope). The proximal end of the small-diameter shaft is attached to a handle, by which a user can hold and manipulate the instrument while inside the body.

[0017] The handle is constructed such that its distal portion (firmly attached to the proximal end of the shaft) can rotate relative to the base portion of the handle. In this way, in the case of a side-view scope, new information can be revealed to the user along with the rotation. A rotation-sensing transducer is disposed within the handle proximal to the small-diameter shaft and is in mechanical communication with the rotating portion of the handle. In this way, any rotation of the shaft (and thereby the imaging sensor) can be sensed and transmitted to an imaging processing unit (connected either wired or wirelessly to the handle) for further image manipulation and orientation correction.

[0018] Illumination for imaging is performed by an optical fiber running through the length of the shaft, or by receiving light from an LED light source within the handle, or by a smaller LED or a series of smaller LEDs present together with the micro-imaging lens and sensor at the distal end of the scope shaft. Wires also run throughout the length of the shaft to transfer electrical signals from the imaging sensor to the handle and ultimately to the image processing unit.

[0019] The sensor / camera is preferably rectangular, defining a rectangular image plane, rather than being trimmed circularly.

[0020] With a sensor firmly attached to the distal tip of the instrument, shaft rotation will change the orientation of the image generated by the sensor. In the present invention, the rotation of the shaft is continuously sensed by the aforementioned rotational sensing transducer. Since the shaft is firmly attached to the front portion of the handle, the rotation of the shaft can be accurately sensed by the transducer. Thus, the rotational state of the shaft (and thereby the sensor) is electronically supplied in real time to the software / firmware that performs image processing. In this way, the orientation of the image generated on the viewing monitor can be corrected in real time by software or firmware that operates an algorithm. The shaft is semi-rigid and allows some limited bending, which is impossible with prior art devices that send the image from the distal tip and optically return it through the length of the shaft to the sensor near the handle.

[0021] The image processing electronic circuit may be present within the handle, but is preferably located remotely from the hand-operated instrument itself and receives an electrical signal from the electronic imaging sensor along with a continuous signal indicating the orientation of the sensor. This rotational sensing transducer may be an encoder, a potentiometer, a magnetometer, or the like. Using this information, the processor restores the image from the sensor in real time to its normal dimensions, i.e., a horizontal dimension parallel to the horizontal line, and the observer can view a video image with a stable orientation even while the sensor is being rotated.

[0022] The present invention covers another important feature in that the handle itself carries another set of electronic circuits, which senses the spatial location of the entire handle, is separate from the tip rotation sensing electronic circuit, and is in addition to the tip rotation sensing electronic circuit. This "additional" electronic circuit may sense the rotation and tilt of the instrument, the pitch, the yaw, the orientation with respect to the earth's magnetic axis, and all other relevant spatial location measurements known in the state of the art. This "additional" electronic circuit may be used in conjunction with the tip rotation measurement electronic circuit to correct the movement of the entire handle related to the surgeon or operator moving the handle in 3D space while rotating the chip-on-tip through the handle's rotation mechanism. The measurement results of the two separate systems (one reads the rotation of the tip with respect to the rest of the manipulative handle, and the other reads the rotation and location of the rest of the handle in space) may be used differentially and cooperatively to achieve an original rotated image without any parallax or further shift in the image rotation produced by the handle movement within the operating room monitor.

[0023] The electronic circuit for the orientation of the scope handle is located on a part of the handle that is not affected by the rotation of the tip of the scope. In some embodiments where the chip-on-tip is rotated by a mechanism at the front of the handle that is proximal to the patient, the second set of handle electronics is located on a fixed handle portion that is distal to the patient and firmly grasped by the palm of the operator's hand, while the operator's fingers manipulate the rotation mechanism for the chip-on-tip.

[0024] The present invention further covers a mechanical system including a third set of electronic circuits and in the form of a "brace" or "sleeve" adapted to the patient at the surgical location. This system can be wrapped around the knee or shoulder so as to relate the patient's anatomical tissue to its location (x, y, z coordinates in the operating room) in the space of a particular body part. The spatial location and rotational electronic measurement results of the body feature of interest are transmitted into the scope handle electronic circuit and / or onto the base system in the operating room. This information is used in a differential and coordinated manner with (a) the chip-on-tip and (b) the other two measurement results of the rotation and location of the handle so that the "true" image rotation correction of the anatomical features imaged by the scope can be achieved and then projected onto a monitor in the operating room or on a computer, or saved. Such a system can exist with minimal guidance, as described at 7Dsurgical.com, and can identify for the surgeon the proper point of entry location on the patient during the surgical procedure. On the monitor, the location and orientation of the surgical instrument are shown overlaid on an X-ray, MRI, CT, or other scan shown on the monitor. This assumes proper surgical entry, after which the scope visualizes the internal tissue. As an alternative to the use of the patient's own scan, the system can utilize a database of images of past similar anatomical tissue and further display on the monitor both the current real-time image and a representative of all past similar anatomical tissue images. The anatomical image database can be further optimized by entering a minimal set of patient data such as date of birth, height, weight, gender, etc.

[0025] The present invention has several other important features. To obtain rotation of the sensor-carrying shaft relative to the handle, a PCB slip ring with brushes for continuous electrical contact during rotation can be utilized. Further, the PCB slip ring can carry as a whole other functions such as an electronic circuit for driving an LED light source, data from an NVram chip capable of holding calibration information regarding the sensor, and a disposable assembly.

[0026] The assembly method of the endoscope instrument is also an important aspect of the present invention. The device is preferably held integrally without screws or threads, but only with snap-together plastic components, and is firmly held together after assembly.

[0027] An endoscope is typically introduced into the body through a cannula (especially in laparoscopic or arthroscopic procedures). Such a cannula usually has a liquid or gas access port (usually with a Luer port fitting) so that liquid or gas can flow into the viewing area at the distal end of the cannula through the annular space between the outer diameter of the scope shaft and the inner diameter of the cannula. The cannula port rotates relatively freely with respect to the cannula body, and further, a sealing path must be realized so that the injected gas or liquid flows only through the annular space of the cannula. A fluid-sealing type slip ring is provided at the fluid port so that the rotation of the instrument can still be performed without interfering with the movement / rotation of the fluid supply tube.

[0028] The present invention provides the same feel to the user of an endoscope as a "regular" or conventional lateral viewing scope, where the user uses the fiber optic illumination port of the scope as a handle and rotates the front "lens" portion while gripping the rear portion of the handle that includes the image sensor. Orthopedic surgeons, in particular, are trained to use arthroscopes having an angle of 30° with respect to the forward viewing direction, such that the FOV of the scope is tilted 30° with respect to the side. Prior to the present invention, the use of chip-on-tip devices in orthopedic procedures has been hampered by the widespread use of this type of operation. The present invention specifically reveals this novel use case.

[0029] The holding and rotation of the entire scope by one-handed operation is an important feature of the present invention and is made possible by the structure of the instrument. Conventional bulky devices cannot be used in this way.

[0030] The correction of the original orientation of anatomical features imaged by a chip-on-tip scope is another important feature of this scope and is accomplished by a plurality of spatial reading systems within the handle of this scope and the patient's reference system.

[0031] Endoscopic procedures, particularly arthroscopic and laparoscopic examinations, are performed by inserting the scope into the body through a cannula. Therefore, the scope becomes immobile once it is fully inserted. There are two main reasons for this. One is to protect the scope during insertion (since the cannula is inserted first, providing a clear and safe path for the scope to enter the body) and during manipulation when the cannula / scope assembly is already inserted through the tissue into the body, because it is the cannula, not the scope, that will receive all the forces applied to the assembly during manipulation. The other reason is to inject liquid or gas into the body through the side port on the cannula and provide a path for it to pass through the annular space between the inner diameter of the cannula and the outer diameter of the scope.

[0032] Another aspect of the present invention is a disposable cannula that includes a luer port that can rotate freely in place relative to the long axis of the cannula. Such a rotating port can rotate freely around its location while allowing liquid or gas to be delivered into or through the inner lumen of the cannula, enabling better management of the liquid / gas line or syringe attached thereto while rotating a lateral viewing scope to view new information. The plurality of devices that achieve this rotation are reusable and are constructed of relatively expensive materials and methods, or the rotation is done in a single cross-section using a single O-ring or material that allows for sealing and rotation. A preferred configuration is a cannula having two O-rings that allows for the use of a disposable grade of material, such as plastic, for the rotating portion of the luer port of the cannula, while maintaining the balance of the rotational force through the friction between the O-ring on the main cannula body and the rotatable luer port. Further, such a cannula provides an input injection port proximal to the location of the imaging sensor. This is a unique feature compared to conventional arthroscopes or laparoscopes where such an injection port is distal to the imaging sensor.

[0033] Embodiments of the present invention further include several structural arrangements that provide for disposability of the distal end of the scope, as well as several different structures and protocols that achieve sterility of the surface of the scope that will be exposed during use of the scope.

[0034] A primary object of the present invention is to improve the efficiency, accuracy, and minimally invasive nature of endoscopic diagnosis and surgery using an extremely small diameter chip-on-tip rotatable scope that provides real-time correction of the rotational orientation of the video signal from the imaging sensor. BRIEF DESCRIPTION OF THE DRAWINGS

[0035]

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Mode for Carrying Out the Invention

[0036] In the drawings, Figure 1 shows a portable hand-held instrument 10 connected to a processing electronic circuit 11 and a monitor generally indicated at 12. Although a cable 14 is shown connecting the instrument to the electronic circuit and the monitor, this connection may be wireless with a transmitter (not shown) within the instrument 10, a receiver (not shown) in the processor 11, and a battery within the instrument. The instrument 10 includes a handle including a base handle portion 16, a forward (distal) rotatable portion 18, and a proximal portion of the handle forming part of the handle, and a scope shaft 20 having a sensor at its distal tip 22, having optical components for forming an image on the sensor, and having a distal end of an optical fiber that conveys illumination generated by an LED either within the handle base portion 16 or the rotatable portion 18. Alternatively, one or more LEDs may be disposed at the tip 22.

[0037] Figure 2 shows only the endoscope 10 having the shaft 20. The rotatable distal portion 18 rotates relative to the fixed base 16. In Figure 2, it is shown that a cannula 21 including a luer port 21a is assembled over the needle / shaft 20. Figure 3 schematically shows an embodiment having a disposable distal section 23 separated from a reusable handle body including an end cap 32, a main body section 34, and a rotatable conical distal portion 36. A needle holder 38 holds the needle or shaft 20, and the disposable holder 38 is rigidly assembled (by snap fitting and snap removal) to the rotatable conical piece 36 such that the components 20, 38, and 36 rotate integrally.

[0038] Figure 3A shows the distal end of the shaft 20 in an example of the zero-degree optical axis. The distal tip 22 is shown in cross-section. The distal tip 22, preferably having an outer diameter of about 1.4 mm, carries the imaging optical component(s) 24, which together form an image on a sensor or camera 26 firmly mounted at the tip ( "chip-on-tip"). The optical fiber 28, shown more schematically in the end view of Figure 3B, provides illumination created by an LED disposed proximally within the handle. Figure 3C shows an LED 29 at the distal tip of the scope shaft as an alternative to the optical fiber. The distal tip may be oval or elliptical with the LED disposed therein, or may further be circular.

[0039] Figure 3D is a photographic image of the distal tip showing a number of distal ends 28 of optical fibers arranged along the sides of the square sensors / optical components 24, 26. This figure shows that the cannula is positioned over the shaft 20.

[0040] Figures 3A-3D show a zero-degree scope in a forward view, while Figures 3E and 3F show a side-view scope. In Figures 3E and 3F, although depicted transparently for clarity, the distal end 22 is shown somewhat enlarged from the rest of the shaft or needle 20. The distal lens-sensor-illumination assembly is angled as shown for a side-view scope, such as a 30° side-view scope, which can preferably be constructed as shown. Similar to the 0° example, the distal tip face 22a is flat and the most distal element is an optical component, usually a lens. The fiber optic components, i.e., the bundle of fibers, are shown at 28 and are located at the side rather than in the center as shown in Figure 3F (however, it is preferred that all are integrally bundled proximally). The imaging optical component is provided with a camera / sensor 26 immediately, i.e., in the proximal direction, and is visible at 24. Both the optical component 24 and the camera / imaging sensor 26 are oriented at an acute angle, e.g., 30°, from the longitudinal axis of the instrument as their optical axes are shown here. The illumination from the fiber is always directed in the same direction as the imaging sensor, which is an important feature.

[0041] Although not shown here, in another feature of the present invention, the end of the fiber optic component 28 may be cut obliquely so as to establish at least a part of a flared shape at the tip of the scope to bend the light rays as desired. In one embodiment, the fiber is partially bent (curved) at a desired angle, and the remaining light redirection is via the oblique cut at the tip of the fiber.

[0042] FIG. 4 shows in exploded view the main components of the portable endoscope 10 by way of an indication of the assembly of the portable endoscope 10 according to one form of the present invention. The housing or base - handle portion including the rear cap 32 of the base portion and the main body 34 of the base portion is designated 16. In this embodiment, the front conical piece 36, which is part of the handle, is connected to the front or distal end of the base 16 so as to be rotatable relative to the base by hand rotation. Fixed to the cone 36 is a rotatable shaft - holding component 38 which rotates with the shaft 20. Note that the shaft - holding component 38 may itself be rotatably connected to the body 34 as in another embodiment below, and the conical piece 36 may simply be fastened onto the component 38 so as to rotate together. In another embodiment (as in FIG. 3), the components 20 and 38 may be disposable and removable from the conical piece 36. In this particular embodiment, the connection between the components 38 and 36 is made by snap - fitting them together such that the proximal end 38a of the needle - holding portion 38 snap - fits into the distal end of the conical piece 36, and this connection is secure and non - rotatable. The cord and end connector of this instrument are designated 14 and 40.

[0043] All components 32, 34, 36, and 38 have no threads or threaded features and are configured to snap fit together firmly and securely with some play for rotation between components 36 and 34. This configuration is preferred because it is simple and highly reliable. Its connection is secure and tight and is preferably designed to lock in a state of a certain standard ingress protection level such as IPX4, including the rotatable interface between components 36 and 34.

[0044] Figures 5 and 5A show the assembled appliance 10, including some details of the internal components of the preferred embodiment. From Figure 5 to Figure 5C, the appliance is either completely disposable or completely reusable (by being processed in an autoclave during use).

[0045] As shown, the needle shaft 20 is fixed to the distal end of the appliance body, i.e., to the shaft holding component 38 fastened to the front cone 36, and rotates with the shaft holding component 38. The cone 36 rotates relative to the base handle portion 16, together with the shaft and the holding component 38. Extending into the base portion 16 is a collar 42 integral with the front cone 36. A sealed rotary connection is made between components 36 and 16 via the extending collar 42, and an O-ring seal 43 is shown sealing this rotatable connection. In the embodiment shown, the collar 42 has a cylindrical heat sink 44 connected thereto, and all of these components 20, 38, 36, 42, and 44 rotate integrally relative to the base portion 16 of the appliance.

[0046] In this form of the invention, the potentiometer adapter shaft 46 extends proximally from the heat sink 44 and can rotate therewith (the additional proximal length 48 shown on the shaft 46 is for assembly). The adapter 46 extends into and engages firmly with a rotatable component (not specifically shown) inside the potentiometer 50. The front conical piece 36 and the needle shaft 20 are fixed in position within the base 16 as shown to be fastened to a structure 52 integral with the housing component 34 when rotated. Rotating the front conical piece 36 and the needle shaft 20 causes the inner components of the fixed potentiometer 50 to rotate, generating a signal representing the degree of rotation. For further electronic circuitry and connection to power, wire leads (not shown) extend from the potentiometer chip or PCB 50, and ultimately the signal is sent to the image processor and monitor either via the cord 14 or wirelessly.

[0047] The heat sink 44 is fastened in contact with the LED driver PCB 56 within the front conical formed piece 36, and the illumination LED 58 is mounted on that PCB as schematically shown in the drawing. Since LEDs generate a significant amount of heat, some form of heat sink is required. The heat sink may alternatively be arranged within the conical piece 36, optionally with a heat conduction path to the outside of the conical piece.

[0048] Preferably in direct contact with the LED is the proximal end of the optical fiber 28. As noted above, there may be many such fibers. Electrical wires 63 are also included in the bundle that enters the needle shaft 20 along with the optical fiber 28.

[0049] Figures 5 and 5A further show the main PCB 64 securely held within the housing and, in particular, fixed within the body section 34 as shown. The wire leads 63 that extend proximally from the needle shaft 20 are ultimately connected to the PCB 64 via a rotation - corresponding connection.

[0050] Instead of a potentiometer, a magnetometer can be used, whereby the relative rotational movement of the magnet is sensed with respect to the orientation. However, in the case of the magnetometer, there is a magnet in proximity to the magnetometer at the proximal end of the potentiometer adapter shaft 46.

[0051] Figures 5 and 5A further show a snap-fit integral assembly of components, which are shown in exploded view in Figure 4, and further in Figures 5B and 5C. The connection between the rear cap 32 and the body 34 is made at 65, and a latching tab 66 or an annular latch engages at the annular proximal end of the body section 34. The O-ring 43 provides a seal. When assembled, the latching structure 66 of the end cap snaps into a corresponding groove or recess in the body 34 to make a permanent connection.

[0052] Figures 5B and 5C further illustrate the assembly, including the internal components of this preferred embodiment. The connection of the conical formed piece 36 of the shaft retaining proximal piece 38 is made by advancing the forward shaft retaining piece 38 through the conical piece 36 with the O-ring 43 remaining in place as shown in Figures 5 and 5A. As can be seen from Figures 5 through 5C, in this embodiment, the conical formed piece 36 is not fastened to the body section 34, but rather is actually fastened to the needle retention piece 38. Thus, there is room for rotation between components 38 and 34 while the O-ring 43 seals its rotatable connection, and the conical formed piece 36 moves with the needle retention piece 38. In Figures 5B and 5C, the retention tab 66 is shown in an annular array at the proximal end of the shaft retention piece 38 for the purpose of making a locking engagement for a secure but rotatable connection with the distal end of the body section 34. Similar retention tabs are shown on the end cap 32 with another O-ring 43 in its location.

[0053] Figures 6 and 7 show the details of one preferred embodiment of the present invention, particularly with respect to the transducer that determines the rotation of the imaging sensor and the optical components relative to the main body of the handle 16. Further, a rotational sensing transducer attached to the fixed portion 32 of the handle (in FIG. 6) is shown as potentiometer 50 in FIG. 7. As shown in FIGS. 5 and 5A, the same heat sink 44 is shown attached to the rotating conical piece 36 to dissipate heat from the LED. If the LED is disposed within the shaft retention component 38 (as shown in FIG. 8 below), such a cylindrical heat sink 44 may not be necessary, but nevertheless, note that the potentiometer adapter shaft 46 that rotates with the front conical forming piece 36, the shaft retention piece 38, and the shaft 20 is included. This transducer or adapter shaft 46 is shown extending through the potentiometer 50. In this way, the resistance of the potentiometer 50 (FIG. 6) securely held within the cap 32 can vary as the piece 36 is rotated, and thus, the resistance of the potentiometer can be converted to a specific rotation through simple calibration at the factory to indicate the rotational position of the camera / imaging sensor and the optical components. The signal indicating the rotational position is derived from the change in voltage due to the change in the resistance of the potentiometer caused by the different rotational positions of the shaft relative to the potentiometer 50.

[0054] Figures 6 and 7 show the preferred form of fixation of the potentiometer 50 within the housing, i.e., within the rear (proximal) cap 32. In FIG. 7, the form of the sheet 68 is shown as a raised boss or flange integral with the rear cap inside the rear cap. This sheet has a shape that fits the shape of the potentiometer 50. FIG. 6 shows the potentiometer 50 in place within the sheet 68 of the rear cap 32 and the intermediate section 34. Figures 6 and 7 further show the electrical contacts 69 of the potentiometer, which will come into contact with a PCB board (not shown) within the rear cap 32.

[0055] In another preferred form of the present invention, the needle 20 including a shaft having a distal end sensor and optical components, and the illumination light fiber 28 are disposable including the shaft retention component 38, but all structures visible to the right (i.e., the rotary conical piece 36 and the handle 16) are reusable. Refer to FIG. 3 as an example. In one embodiment, since the LED can be included in the reusable portion, it is necessary to couple the light from the LED to the optical fiber 28 extending to the tip of the shaft. For this, an exact coupling is required where the fiber is in contact with the internal components of the cone 36 that receives the light from the LED, and it is preferred that the proximal end of the optical fiber 28 actually contacts the LED light transmission components inside the cone 36. Preferably, some form of spring is included that allows the fiber to be in such a rotatable contact state. In one aspect, by including a weak buckle in the optical fiber 28 such that as the fiber is pressed against the components of the reusable section and the curvature of the weak buckle increases slightly as the buckle tightens back, the optical fiber 28 itself can act as a spring.

[0056] However, in another preferred configuration, the LED is disposed within a disposable section, i.e., within the shaft-containing component 38. This is shown in FIG. 8. In FIG. 8, an LED 58 (not shown) is mounted on a PCB 56 inside the component 38. The end of the optical fiber 28 (not shown) receives illumination from the LED, and a wire lead (also not shown) from the shaft 20 extends to an electrical / data terminal connector 70 and interfaces with a mating connector 70a on the conical piece 36 that is not disposable and is part of the handle. The wire carries power to the LED and data from the chip-on-tip sensor. The PCB 56 in this case is in contact with a smaller heat sink 71, and the heat sink 71 is included within the shaft retaining component 38 as shown. This arrangement functions such that the entire body of the shaft retaining component dissipates the heat of the LED, and in this regard, the shaft retaining component 38 may be formed of or may include metal (for clarity, the shaft retaining component 38 is shown as a transparent component in FIG. 8).

[0057] FIG. 8 further shows an example of a mechanism that can be utilized to attach the shaft retainer 38 to the proximal rotatable conical piece 36 in a releasable attachment. A stud 72 permanently attached (as shown by bolts) to the shaft retainer 38 is snap-fitted into a receiving hole (one is visible at 72a) at the distal end of the conical piece 36 to hold the components together in secure contact with the electrical connector and is gripped by a latch of the conical piece. A springable release portion (not shown) is provided on the conical piece 36 to allow the stud to be released after use of the needle.

[0058] Figures 8A, 8B, and 8C show an alternative form of releasable latch for securing the disposable needle holder 38 to the conical piece 36 as an alternative to the releasable latch of FIG. 8. In this embodiment, the needle holder 38 has a resilient plastic lever 73 with a hooked proximal end for engaging within a recess of the conical piece, which is best seen in FIGS. 8B and 8C. The exploded view of FIG. 8C illustrates the assembly / disassembly of these two components. When the attachment is made, the needle holder 38 (including the needle shaft not shown) is pressed onto the conical piece 36, thereby sliding over the collar 36a of the conical piece. The correct orientation is achieved by a bump or boss 74 on the conical piece, and when the two are assembled and fit snugly into the detent 74a, a unique orientation is provided. As the needle holder 38 is slid onto the conical piece 36, the resilient lever snaps into the recess 76 of the collar 36a. As piece 38 is slid over the collar 36a, thereby deflecting the lever 73, the lever snaps securely into place when the lever is fully assembled. Further, this assembly integrally engages an electrical connector between components 38 and 36. To remove the needle and needle holder 38 after use, the distal ends of the lever 73 are squeezed towards each other as shown in FIG. 8C, allowing piece 38 to be pulled away from the conical piece 36.

[0059] FIGS. 9 and 9A show one preferred example of the configuration within the shaft retaining piece 38 when the LED is disposed within the disposable portion of the instrument as in FIG. 8. FIG. 9A shows the distal piece 38b of the assembly, with the needle or shaft 20 secured to the distal end. A second proximal piece 38c is shown secured to piece 38b in FIG. 9A, essentially forming the shaft retention piece 38 as shown in FIG. 8. FIG. 9 shows an exploded view of the same two components disassembled. Components 38b and 38c are permanently integrally secured as the distal piece 38 as shown in FIG. 9A.

[0060] In FIG. 9, at the center of the component 38, i.e., on the longitudinal axis and coinciding with the shaft or needle 20, is the fiber optic component end 28 that interfaces with the LED 58 (visible in FIG. 9A), and the LED 58 is mounted at the center of the other component 38c. The wiring 78 is connected to the LED within the space defined between the components when assembled. The internal wire shown near the fiber optic 28 is provided by the imaging camera. As shown, the cylindrical stud 80 around the fiber optic component end may be provided to fit within the socket 82 adjacent to the LED 58 for proper alignment of the two components and the LED and the fiber optic component or the fiber optic component bundle end.

[0061] FIG. 9 further shows the metal contacts within the contact pads 84 on one side of the component 38, and additional contacts 86 on the opposite side. These are positioned on opposite sides of the longitudinal axis of the instrument. The contacts 84 are provided for camera control and data readout and make contact with mating contacts 84a on the other component 38c. The connector 86 is for LED illumination control and, when the components 38b and 38c are fastened together, they work with the contacts 86a on the component 38c. An example of a rubber elastic connector is from the Z-axis Connector Company at the web link: axisconnector.com / products / z-wrap / .

[0062] These elastic cores and wire-wrapping connectors may be adapted to make contact with any number of circuit board pads, for example, for sets of 10, 20, or 100 wires each.

[0063] In the assembly of the two components shown in FIG. 9A, the proximal side of this assembly continues the connections for LED lighting control (at 86), and for camera control and data reading (at 84). The heat sink extends from the contact with the LED 58, i.e., the contact with the PC board on which the LED is positioned, and is exposed at 88 at the center of the assembly. When the assembled needle retention piece 38 is fastened to the conical forming piece 36, such that the disposable parts and the reusable parts of the instrument are in a connected state, the heat sink at 86 makes a solid contact with the heat sink component 88a of the reusable parts of the instrument, as shown in FIG. 8.

[0064] Figure 10 shows an exploded view of a form of slip ring 90 that can be used in the apparatus of the present invention. As discussed above, the rotational connection must be made between the rotatable components 20, 38, 36 and the non-rotatable handle portion 16. The electrical connection type slip ring set 90 shown in FIG. 10 is manufactured by the company MOFLON of Shensen, China. What the ring has is a contact that guarantees a stable connection of a plurality of electrical pads, including power and data connection parts for the camera / imaging sensor, and further including power for the LED, assuming that the LED is arranged within the disposable section of the instrument. The particular slip ring set 90 shown has a central hole 92, and this hole can receive components such as rotatable components for use in the transducer (for example, the non-scale color 42 shown in FIG. 5), and any other on-axis components inside the rotatable conical piece 36, such as parts of the LED heat sink 44 that can be shaped to fit into the hole of the slip ring. This hole is well-suited for this purpose. This is preferably a slip ring that can accommodate high-bandwidth electrical transmission from an optical CMOS chip to an on-board PCB. The slip ring allows the rotation of the needle to exceed 360° relative to the back of the handle without twisting the wire, enabling a larger viewing FOV. Combined with a magnetic encoder consisting of a multi-turn potentiometer or a Janus magnet, and from the encoder circuit board, as an example, due to being isolated only by a gap, accurate measurement of angles greater than 360°, and correction of the patient's anatomical tissues in the video display of the monitor or tablet hardware are possible.

[0065] In another embodiment of the present invention, the tip can be rotated at high speed (e.g., using a motor not shown). The high-speed rotation of the tip in the angled view enables a continuous and larger FOV that could not be achieved without the high-speed rotation of the tip in the angled view. This is advantageous in robotic vision that enables anatomical tissue over a wide area without any loss of high-quality imaging. For example, it can substitute a fish-eye lens for the camera when the uniformity of the realized image is compromised in order to have a large FOV. It should be further noted that in the case of a zero-degree scope including a square format, a rapid rotation will result in a larger circular FOV having a diameter equal to the diagonal of the square.

[0066] In another embodiment of the present invention, an off-axis method for measuring the rotation of a chip-on-tip needle shaft is provided. Referring to FIG. 11. In this arrangement, an off-axis displacement measuring device such as an encoder, a magnetometer, or a potentiometer, or an optical device is calibrated to convert the displacement into a relative rotation between two surfaces on which the displacement sensor is disposed. The rotation of the scope needle is transferred off-axis via gears 93, 94 and measured by potentiometer 50a or other device. One method is an optical reflection method via an infrared sensor, which is well known in the art and is, for example, a sensor of Keyence Corporation, Itasca, Illinois, USA, and as a specific example, it is sensor IL-030. In another example, the mechanical method of displacement is calibrated against the rotation angle reading method using a displacement sensor that utilizes a digital contact device such as, for example, an LVDT (linear variable differential transformer) or a sensor of the GT2 series of Keyence Corporation. In another example, a time-of-flight (TOF) sensor can be used to measure the displacement. The resolution of the rotation angle is the key to good measurement and stable visual recognition of the rotation video during operation. Furthermore, a small-sized handle may suppress the size of the displacement sensor used, which is a consideration when selecting from the above list of examples of displacement sensors.

[0067] Another feature of the present invention is a measure for sealing two relatively rotating parts of a scope handle while allowing relative rotation. This may be a disposable scope that can have lower-cost components, so a less sophisticated mechanism is preferred. In the above-described embodiment, at least one O-ring 43 is installed between the two components, sealing the gap while allowing rotation about the longitudinal axis of the instrument via reduced friction. The two components can be held in place horizontally relative to each other via a mechanism that can be further adjusted to optimize the friction on the O-ring. In one embodiment, tension is applied by holding the rear component on the spindle via a screw loaded onto a spring structure. The screw is passed over a potentiometer screw that can rotate relative to the body of the potentiometer. The body of the potentiometer is firmly installed on the shaft and firmly against the front half of the handle. In other embodiments, the O-ring can be replaced with a simple plastic or paper band, and the plastic or paper band allows both sealing between the two halves and the necessary movement by joining the two halves. For small rotation angles, this can be achieved by a small flexible material such as a sterilized cylindrical-shaped tube made of a thin plastic material such as a bag positioned between the two halves. Adhesives, epoxies, or heat bonding, or other means of adding material to each of the halves, are examples of assembling the system integrally. The soft material allows one half to be twisted and rotated relative to the other half up to the point where the material prevents further rotation beyond a specific angle. Round cylindrical bags with a diameter of several centimeters and a length of 10, 20, or 30 centimeters can easily accommodate rotations of plus 180° and minus 180° while stretching. In another embodiment, the two halves overlap and can slide and rotate relative to each other by virtue of the overlap or with the help of an O-ring between the halves.

[0068] Another aspect of the present invention is shown in FIGS. 12A - 12F and includes a disposable cannula 95 therein.

[0069] The cannula 95 consists of two components: (1) the main cannula body 96 and (2) the rotatable luer port 97. The main body 96 is preferably constructed by overmolding a plastic proximal insertion port base 98 onto a metal cannula shaft 99. Alternatively, the entire main body 96 (both 99 and 98) may be made from a piece of plastic melted together. The rotatable luer port 97 is made of plastic material and is designed to be able to slide easily longitudinally over the cannula shaft 99 as shown in FIGS. 12B and 12C and be pushed to reach its final rest position through two O-rings 100. The two O-rings 100 are strategically positioned on the insertion port base 98 distally and proximally from the region of the insertion port containing the communication hole 102, although it is preferred that a number of holes communicate with the interior of the cannula. The rotatable luer port 97 can then be locked in its longitudinal proper position. In this assembled rest position, the rotatable luer port 97 can freely rotate around the main body 96 while being locked in place longitudinally as shown in FIGS. 12B and 12C, can have an interference fit with the two O-rings 100, and can achieve a seal against the fluid (liquid or gas flow) injected through the luer input port 104. The luer input port 104 can have an industry standard luer connection or any other thread or locking mechanism that will ensure proper flow of liquid or gas through the luer port. In FIGS. 12A and 12B, the rotatable luer port 97 is shown with only the single luer input port 104, but it may also be made to have two such luer input ports.

[0070] Measures for the rotary lure port 97 to be locked in place longitudinally while freely rotating in its assembled position can be designed in this preferred embodiment as follows. The rotary lure port 97 is pushed longitudinally across the distal end of the main body 96 into place and locked in place on top of the insertion port base 98 so that it cannot be moved or pushed out in the opposite direction. It is further constructed with a one-way feature such as the hinge end 106 shown in FIGS. 12A - 12C. The rotary lure port 97 can only rotate in place. The hinge end will open when the lure port 97 is pushed into place (from distal to proximal), and then collapse and interfere distally with the carefully designed annular wall edge 108 on the insertion base 98 and the proximal wall 110 when the lure port 97 reaches its final position. Such distal and proximal wall structures will prevent the rotary lure port 97 from moving longitudinally. Refer to FIG. 12C.

[0071] The fully assembled cannula 95 is inserted over the shaft 20 of the lateral viewing scope 10 as shown in FIG. 12D and locked in place as shown in FIG. 12E. The insertion port base 98 has means for mating with the nose piece 38 of the scope and will securely lock with the nose piece 38 in a specific orientation such that the angled plane of the distal tip 22 of the scope is aligned with the angled cut surface of the distal tip 112 of the distal cannula shaft portion 99 so that the cannula body does not obscure the sensor's field of view when the two are connected. See FIG. 12F. Such alignment of the two planes is essential for the lateral viewing scope. The indicia symbols 114a and 114b on both the proximal end of the cannula insertion port base 98 and the nose piece 38 of the lateral viewing scope can assist the user in orienting the two components when locking the cannula 95 onto the scope 10 as shown in FIGS. 12D and 12E. An additional O-ring 100 (FIG. 12D) is present on the distal nose piece 38 to seal the interface between the nose piece 38 and the insertion port base 98 (when the scope and cannula are locked together) and prevent backflow of gas or liquid through that interface when fluid or gas injection is occurring through the luer access port 97, thereby forcing the flow towards the distal tip 112 of the cannula shaft portion 99. An O-ring or similar sealing mechanism may also be present inside the proximal end of the insertion port base 98.

[0072] (In FIGS. 1 - 9) In all of the embodiments of the lateral viewing scope described heretofore, whether or not the distal nose piece 38 of the scope (which is rigidly connected to the scope shaft 20 including the imaging sensor) is permanently attached to the scope handle, they all incorporate the rotational function of the lateral viewing scope shaft 20 (and thereby the sensor) within the handle (item 18 in FIG. 1 or item 36 in FIG. 4). In other words, in all of the embodiments described heretofore, it is item 36 or item 18 (the most distal component of the handle) that allows the user to rotate the sensor by rotation of such a distal handle piece relative to the remainder of the handle (pieces 34 and 32 in FIG. 4).

[0073] In another embodiment 130 of the present invention (from FIGS. 13 to 25), the rotation function may be present on a detachable and thus disposable part of the scope rather than within the handle. Refer to FIG. 13. Thus, in this embodiment, the detachable scope 131 (which further includes a rotating element 135) is disposable, but the handle 132 to which it is connected can be reused. Furthermore, in this embodiment, it is preferable to wirelessly communicate the handle 132 with the video processing hardware 11 and the monitor 12. However, in a particular embodiment, the video data from the imaging sensor may be wirelessly sent from the rotating element 135 to the processor 11 via a transmitter disposed within the rotating element 135 or within an attached fixed element 136.

[0074] The detachable scope 131 is further shown in FIG. 14. It consists of three separate components: (a) a small-diameter assembly 139 consisting of a metal shaft 20 with an imaging sensor and a lens at its distal tip 22 and a fiber optic end tube 140 on the proximal end of the metal shaft 20 (as previously described and further referring to FIG. 15); (b) a distal rotating scope cavity element 135, which is substantially a modified version of the nose piece 38 of the previous embodiment and can further fit with the cannula 95 previously described in FIG. 12 - this is a rotating part in this embodiment - the distal rotating scope cavity 135 is preferably equipped with a removable lever 137 for easy handling during rotation; (c) a proximal fixed element 136, which is a component of the detachable scope 131 that fits with the reusable handle 132 and becomes fixed and non-rotatable when connected to the reusable handle 132.

[0075] As shown in FIG. 15, the metal shaft 20 connects the distal tip 22 to the proximal fiber optic end tube 140. At the distal tip 22, there are an imaging sensor and an imaging lens together with an angular cut portion of the end face equal to the side view design angle of the scope. The distal tip assembly 22 is described in more detail above (FIGS. 3E and 3F).

[0076] The fiber termination tube 140 is attached to the proximal end of the metal shaft 20 and is designed with a longitudinal cut 142 so that, as shown in FIG. 16, the electrical wire 141 can exit the proximal end of the metal shaft 20 and exit the fiber termination tube assembly for further connection to an electronic circuit. However, the optical fiber can terminate straight at the proximal end 143 of the fiber termination tube 140. The wire and the optical fiber run from the distal end through the inner diameter of the metal shaft 20. The two end faces of the completed subassembly in FIG. 15 may here be prepared in any manner that can provide good optical quality imaging and light transmission. Both end faces of 139 may for example be polished.

[0077] The distal rotatable scope cavity 135 is assembled over the distal end 22 of the metal shaft 20 and can be retained in proper longitudinal location along the length of the shaft by sliding it (distal to proximal, dotted arrow in FIG. 17). The exact location along the shaft at which the rotational element / scope cavity 135 is retained can be defined by a manufacturing jig to ensure that (a) the length of the scope shaft 20 matches the length of the cannula shaft when the cannula 95 is locked onto the distal end of 135, and (b) the orientation of the face cut of the distal tip 22 of the scope shaft 20 aligns with the orientation of the distal end portion 99 of the cannula shaft 95 (see FIG. 12F). The O-ring 100 is applied to the distal end of 135 (FIG. 17) to prevent backflow when gas or liquid is injected through the luer port 98 of the cannula when the cannula 95 is attached over 135. Securing the distal rotatable scope cavity 135 onto the shaft 20 can be accomplished either by using epoxy through the distal end 138 (FIG. 18B) or, for example, by utilizing two softer molded plastic pieces 145 which are inserted from the proximal end of the distal rotatable scope cavity 135 and wedge-lock in place between the outer diameter of the shaft 20 and the inner diameter of the distal groove 158 of 135 (FIGS. 18A and 18B). Additional epoxy can be applied from the proximal and / or distal ends of the component 135 to further secure all components in place and seal against water ingress into the interior of the cavity created by the assembly of 135 and 136 around the shaft 20 of the assembly 139.

[0078] For rotation detection and evaluation, a potentiometer wiper 147 is attached to the proximal end face of the distal rotation scope cavity 135 as shown in FIG. 18C. A wire further exits the wiper and is shown to be further connected to an electronic circuit to measure the resistance of the combined open potentiometer (156 and 147). This is the preferred rotation sensing transducer for the lateral view scope of this embodiment. The conductive potentiometer wiper 147 shown in FIG. 18C is part of the innovation of this embodiment by utilizing a radial open potentiometer formed from a printed polymer conductive paint, such as a SENSOINK custom radial potentiometer model made by Hoffmann-Krippner (hoffmann-krippner.com / pet-sensoink / ). See FIG. 18D for details. Open potentiometers such as those proposed in FIG. 18D are printed on FR4 or PET and require a conductive wiper such as 147. In this embodiment, since the conductive wiper 147 contacts the conductive track 156a (which remains fixed inside 151) when the wiper is rotated (by the rotation of 135), this can be a very low-cost and reliable solution for disposable products, as described in this embodiment. Thus, the wiper 147 and the printable conductive ink track 156a together form a potentiometer in this embodiment. The layout of the wiper depends on the particular application, resistor material, and design. Generally, so-called scoop wipers are used, but they are increasingly being replaced by scratch wipers. In either case, the shape and material of the wiper will be determined by the application and they can be customized for a particular use of the product (such as number of uses or installation limitations).

[0079] Alternatively, the above-described SENSOINK potentiometer design can also be replaced by a custom-made radial SENSOFOIL thin-film potentiometer (hoffmann-krippner.com / sensofoil-membrane-potentiometers / ) by Hoffmann-Krippner. Its shape is very similar to the shape of FIG. 18D. The Sensofoil thin-film potentiometer consists of several layers, and several layers are separated by so-called "spacers". These layers include (depending on the application requirements) (a) a collector thin film as a wiper tap for hand-actuation, wiper-actuation or magnet-actuation, (b) a spacer between the upper thin film and the lower thin film, (c) a base thin film having a potentiometer resistance track, and (d) an adhesive film for attachment. The thin-film layers are connected to each other through mechanical or magnetic pressure. If a magnetic Sensofoil model is selected, the wiper 147 for the SENSOFOIL model of the printed radial potentiometer can be a completely passive non-conductive element such as a threaded screw with a soft rounded tip, for example, or even a non-contact wiper. A person skilled in the art can easily utilize and install the SENSOFOIL potentiometer track and wiper. Contact can be achieved either by hand or with a mechanical wiper. Non-contact operation is also possible by using a magnet.

[0080] Here, the print potentiometer 156 can slide over the proximal end of the fiber termination tube 140, and the ground plate 154 (metal sheet metal cutout) can be snap-fitted onto the metal shaft 20 as shown in FIG. 18C. A wire is further shown coming out of the ground plate for further connection to an electrical ground. The ground plate can be designed to mechanically flex (e.g., by a designed cutout feature) onto the shaft 20 by compression onto the shaft 20 so as to make sufficient mechanical and electrical contact with the metal shaft 20 and snap-fit onto the shaft 20 as shown in FIG. 18E. Such a ground can be useful for ESD (electrostatic discharge) on the metal shaft as it quickly moves such charges to ground and away from the imaging sensor, thereby protecting the electronic imaging sensor at the distal tip 22 of the scope shaft from ESD discharges.

[0081] Before the subassembly of FIG. 18C can proceed further towards completion, the wire 141 from the sensor, the wire from the wiper 147, the wire from the potentiometer track 156a, and the ground plate 154 must first be soldered onto the through-hole PCB 149 shown in FIGS. 19A - D. Next, a resilient connector 150 of a well-known configuration is attached in place through the opening in the bottom half 151 of the proximal fixed scope cavity component 136 and assembled to be in contact with the PCB 149 (FIG. 19A is an exploded view). The through-hole PCB 149 is locked in place within the bottom half 151 as shown in FIG. 19A. The combination of the resilient connector 150 and the through-hole PCB design 149 provides a reliable, low-cost, and ingress-protected electrical connection. The resilient connector 150 may be a custom design made by Z-axis Co. such as Z-wrap gold (zaxisconnector.com / products / z-wrap / ) or other similar resilient connector designs. The resilient connector 150 consists of a soft elastomer having a number of equally spaced and wound-around gold conductive thin wires 153 as shown in FIG. 19B, which further shows the PCB 149 and a similar through-hole PCB 152 of the handle (discussed below), both of which are pressed against the compressible connector 150. The spacing of the gold conductive wires 153 of the connector 152 can be less than 100 μm so that a number of gold wires can contact its surface even if they are small solder pads. The elastomer connector 150 and the PCB 149 are used to make electrical contact with the reusable handle 132 in the following manner: A through-hole PCB 152 (similar to the through-hole PCB 149 assembled within the component 151) is positioned and aligned within the reusable handle 132 (FIG. 13), such that when the detachable scope 131 is connected to it, the solder pads of the two through-hole PCBs are spaced apart and perfectly aligned with each other as shown in FIG. 19B.When the disposable scope 131 is connected to the reusable handle 132 and locked in place, the height of the elastomeric connector extending beyond the proximal end face of the scope 131 is designed such that the elastomeric connector can be slightly compressed between and in contact with both of the two through-hole PCBs 149 and 152. Refer to Figure 20C. One of ordinary skill in the art will readily recognize how to utilize an elastic connector to properly electrically connect the signals between the detachable scope 131 and the reusable handle 132. By providing sufficient slack in the wires soldered to the through-hole PCB 149 of Figure 19A, not only ease of assembly but also rotation of the rigidly connected assembly of 139 (Figure 15) and 135 with respect to 136 should be achieved. Any other style of standard electrical connector, including a pogo pin mating pair, can also be used to transmit all electrical signals from the detachable scope 131 to the reusable handle, but the elastic configuration of Figure 19B is a preferred embodiment for the present invention due to its simplicity and low cost.

[0082] To limit rotation, as shown in Figure 18A, a stopper 146 is included on the rotating scope cavity component 135, together with a fitting stopper 157 (Figure 19A) on the bottom piece 151 of the fixed scope cavity 136, such that the rotation of the distal rotating scope cavity 135 is mechanically and rotatably aligned to avoid the dead zone 144 (Figure 18D) of the SENSOLINK or SENSOFOIL track 138. In other words, in this embodiment, the rotation of 135 will be less than 360 degrees, which is the limit of the SENSOLINK and SENSOFOIL potentiometer track design. The stopper ensures that the wiper 147 (Figure 18C) can scan the entire track 138 except for the dead zone 144.

[0083] In this regard, the subassembly of FIG. 18C can be installed on the bottom piece 151 of the proximal fixed scope cavity component 136 (FIG. 19C) by carefully placing the SENSOINK potentiometer 156 and the ground plate 154 in specially designed pockets within 151 to securely hold them in place. When the SENSOINK potentiometer 156 is securely held in place, the wiper 147 is designed to make electrical contact with its track 156a (FIGS. 19C and 19D). The O-ring 148 near the proximal end of 135 further allows the component 135 to rotate with respect to the components 151 and 159 when assembled, while protecting against liquid ingress across the interface between the distal rotating scope cavity 135 and the proximal fixed scope cavity 136, as seen in FIG. 20A.

[0084] Prior to this assembly, the top half 159 of the proximal fixed scope cavity 136 is prepared as shown in FIG. 19D. In this half, a small PCB 160 containing a non-volatile memory (NVRam) chip can be fastened in place, and the NVRam chip can be programmed at the time of manufacture to hold information regarding a particular disposable assembly, such as model and lot numbers, rotational calibration data and other hardware calibration data, and in particular calibration data for the imaging sensor. An electrical wire connection 166 may first be made between the NVRam chip 160 and a second pass-through PCB 149 (similar to that of FIGS. 19A and 19B). Next, a second elastic connector 150 is passed through an opening on the proximal end of 159 and fastened in place together with the second pass-through PCB 149 from the rear. The NVRam chip PCB may be replaced inside the top half 159 by an RF-ID tag that can wirelessly transmit such calibration and product information to a corresponding receiver inside the reusable handle 132.

[0085] Since these components are in place, the top half 159 is ready to be locked in place on the bottom half 151 and around the rotating component 135. The mating and locking features 163 may be designed on the molded pieces 151 and 159 to allow the molded pieces 151 and 159 to snap fit together without the need for epoxy or screws. Refer to FIGS. 19C and 19D. A suitable form of gasket material 165, or further a mechanical design seal, may be applied on the peripheral portion of the upper half 159 (shown by thick lines in FIG. 19D) to further seal the interface between 151 and 159 from water ingress.

[0086] As shown in FIG. 19C, a further O-ring 162 on the fiber termination tube 140 can achieve protection against water ingress at the opening 164 (FIG. 19A) through which the fiber termination tube must extend from the proximal end of the fixed scope cavity 136 shown in FIG. 19C. The O-ring 162 and the opening 164 it seals must be designed such that the tube 140 can rotate with slight friction while the O-ring 162 can further protect against water ingress.

[0087] Accordingly, the seal at the distal end 138 of the rotatable component 135, the O-ring 148 at the proximal end of 135, the gasket 165 on the peripheral portion of the top half 159, and the O-ring 162 on the fiber termination tube 140 together can provide complete protection against water ingress into the internal cavity of the detachable scope defined by 135, 151, and 159.

[0088] To be equivalent to the standard arthroscopic configuration method, the removable lever 137 (Figs. 13A and 13B) is preferably mounted on the distal rotating scope cavity 135 on the side opposite to the direction in which the lateral view plane of the distal end face of the scope 22 faces. Thus, when the lateral view plane is rotated so as to be visible at 12 o'clock, the removable lever 137 should point to 6 o'clock; refer to Fig. 20A. The rotating lever 137 preferably extends beyond the outer diameter of the annular rim 196 of the fixed component 136 so that the user can access it by reaching over the raised portion 196 while remaining held on the handle 132. Refer to Figs. 13, 20A and 23.

[0089] Some of the drawings from 20A to 20C depict that the fully assembled disposable / detachable scope 131 is ready to be attached to the reusable handle 132. The proximal sides of the assembled lower and upper halves 151 and 159 are designed with locking features 167 to ensure (a) proper alignment between the through-hole PCB 149 on the detachable scope 131 and the same through-hole PCB 152 on the reusable handle, (b) proper alignment between the center of the proximal end 143 of the fiber termination tube 140 and the light output 174 of the LED emitter present inside the reusable handle, and (c) mechanical locking of the scope 131 onto the reusable handle 132. Fig. 20C, which depicts the position of the distal end face 178 of the reusable handle 132 in a transparent manner with respect to the proximal end face of the disposable scope 131 when the two assemblies (131 and 132) are locked in place, further clarifies the required alignment of the through-hole PCBs between the two assemblies (as pointed out in Fig. 19B). Figs. 20B and 20C further highlight the required alignment between the proximal end face 143 of the fiber termination tube and the light output 174 of the LED emitter present inside the handle to ensure sufficient light transmission to the illumination fiber running from the proximal end face of the fiber termination tube 140 to the distal end 22 of the shaft.

[0090] Surely, an asymmetric feature 172 (on the scope 131 (FIG. 20B)) that can mate in a unique orientation with a corresponding asymmetric feature 173 (on the handle 132 (FIG. 21B)) is constructed on the interface surface between the two pieces such that the scope can be locked in a particular rotational orientation simply by using the reusable handle 132. After the scope 131 is locked in place relative to the reusable handle 132, it is disconnected by pressing or sliding on the lever 171, thereby releasing the handle latch 179 (FIG. 21B) and unlocking them from the locking feature 167 on the scope 131, whereby the scope 131 can be released from the handle 132.

[0091] A block diagram showing the preferred content of the reusable handle 132 is shown in FIG. 21A.

[0092] The distal end 178 of the reusable handle 132 mates with the disposable scope 131. The proximal end 186 of the handle of this rechargeable embodiment mates with the docking station 177 (FIG. 22) during charging. The light source that supplies illumination to the scope is preferably an LED 180 (FIG. 21A) mounted on a heat sink 181 for thermal management. The light from the LED is captured and guided by a light guide 183 on a plane 174 that coincides with the location of the proximal end face 143 of the fiber optic end tube 140 (FIG. 20) for effective optical coupling. Such optical management can be achieved either by a TIR (Total Internal Reflection) lens or an optical pipe, or by moving the LED emitter as close as possible to the proximal end face 143 of the fiber optic end tube 140 when the scope 131 is locked in place by the handle 132. One skilled in non-imaging optics can design such a transmission and an optical coupling system for efficient optical coupling from the LED emitter to a fiber that exists within the length of the shaft 20 of the disposable scope 131 and moves the light to the distal end 22 of the shaft for proper imaging. In a preferred embodiment of the cordless handle 132, a rechargeable battery 190 is further housed inside the handle 132 and is electrically connected to an IP standard connector 192 for contact charging by the docking / charging station 177 of FIG. 22. Inductive charging can also be used, in which case the connector 192 should not be necessary. If the handle is wired to the image processing hardware 11, 190 or 192 is not needed. Instead, a multi-core cable 14 (FIG. 1) can transmit all electrical information to the image processing hardware external to the handle while further supplying power to the scope. Such a cable preferably exits from the proximal end 186 of the handle as shown in FIG. 2. A lighted indicator 193 external to the handle may be used to inform not only the charging status of the battery, but also, if included, the strength of the wireless connection to the image processing hardware, or any other information that may need to be communicated to the user.A number of IP standard buttons 194 may also be located on the outside for different functions, for example, to take pictures, start / stop video capture, and power on for the reusable handle 132.

[0093] The PCB 185 inside the reusable handle will manage all electrical and electronic functions as follows. · Manage NVram data from the disposable scope 131. In the case of an RF-ID tag, the handle PCB will include a corresponding reader to access such information from the disposable scope. · Communicate with the image sensor at the distal tip 22 of the shaft 20 of the disposable scope 131. · Communicate with the rotary transducer 156 from inside the disposable scope 131 and manage the ESD protection ground plate from the disposable handle. · Drive the LED. · Manage buttons and illuminated indicators and transfer such information to a tablet or a monitor external to the handle. · Perform all necessary power management of the rechargeable battery. · Perform some prior image processing and prepare to transfer the image data from the sensor to the image processing hardware external to the handle (either via wired or wireless communication). · In the case of a cordless handle embodiment, drive and manage the wifi transceiver 187 present inside the handle for all information communication with the image processing hardware and the tablet.

[0094] The housing of the reusable handle is preferably designed with some level of ingress protection (IP: Ingress Protection) against water ingress, preferably IPx4 which protects against spraying from a wide range of angles. Other IP ratings may be implemented depending on the intended use of the scope.

[0095] The recyclable scope 132 can be connected to the video processing hardware 11 via the cable 14 (FIG. 1). In a preferred embodiment, the handle 132 communicates wirelessly with the video processing hardware 11. In such an embodiment, the handle 132 must include a battery 190 that can be recharged on the charging docking station 177 when not in use, as shown in FIGS. 22A and 22B. The docking station can charge the handle inductively (without physical connection) or by contact charging. In the case of contact charging, as shown in FIG. 22B, it is preferable to install the handle 132 with its proximal end 186 in contact with the charger. In this arrangement, it is preferable to add a dust cap 188 on the distal end 178 of the handle to protect the electrical-optical connection from accumulated dust.

[0096] In the case of contact charging, it is preferable to use a waterproof and dustproof fitting pogo pin pair (192 on the handle and 189 on the docking station) provided at an appropriate location on the docking station 177 (FIG. 22) and on the proximal end of the reusable handle 132 (FIG. 21C). By doing so, when the handle is stationary within the docking station, proper electrical contact can be made between the two pogo pin pairs. The IP-standard pogo pin pair (mill-max.com / products / new / spring-loaded-pogo-pins) manufactured by Mill-Max (or other companies) functions well for this embodiment. The asymmetric mechanical feature 199 on the interface surface between the docking station and the proximal end 186 of the reusable handle 132 can be designed to ensure one-way docking and charging of the handle (FIG. 22A). The charging station 177 may further have a lighted indicator for indicating the charge state of the battery within the handle 132.

[0097] (With 131 and 132 integrated), the embodiment of 130 can be used clinically from a simple environment equivalent to a clinic to a complex environment equivalent to an operating room. In any case, since the handle 131 is reusable, it will need to be reprocessed or resterilized each time before use. Depending on the clinical environment, the reusable handle may be designed to be resterilized by being processed in an autoclave or by some other sterilization process such as an ethylene oxide or hydrogen peroxide sterilization cycle. At the same time, the reusable handle may further be designed to be reprocessed by chemically cleaning its outer surface with an appropriate disinfectant and / or immersing it in an appropriate disinfectant. One skilled in reprocessing can easily design the hardware and electro-optical-mechanical assemblies (such as those of the reusable handle 132) to withstand multiple cycles of resterilization or reprocessing.

[0098] Another preferred embodiment of 130 is an embodiment that does not require resterilization or reprocessing to reuse the non-sterile handle 131. Instead, according to the present invention, as shown in FIGS. 23A - C, a specially designed sterile sheath 175 can be placed over the distal end of the non-sterile handle 132 in a simple manner by using only one gloved hand. In this way, under the cover of the sterile sheath 175, the reusable (non-sterile) handle 132 can be connected to the sterile single-use scope 131 and brought into the sterile environment of the operating room for use in an endoscopic procedure.

[0099] Covering the reusable scope assembly with a sterile sheath is cumbersome, and moreover, this requires the user to wear multiple sterile gloves and use both hands. Different from some prior art such as U.S. Patent No. 8,317,689 (and instructions for the use of the Vision Scope System), the object of the present invention is to provide a sterile sheath and cover the reusable scope handle with the sterile sheath by a one-handed operation using only one glove.

[0100] In order to cover the reusable non-sterile handle 132 with the sterile sheath 175, it is preferable that the handle remains stationary on the charger with the distal end 178 of the handle in contact with the charger (FIG. 23A (opposite to the charging orientation depicted in FIGS. 22A and 22B)). Thus, the user must first flip the handle from its charging orientation in FIG. 22B (after removing the dust cover 188) to the position depicted in FIG. 23A before putting on the sterile gloves. With the handle 132 stationary within the charger as in FIG. 23A, the user can then don a set of sterile gloves at this time. The sterile sheath assembly 195 of this embodiment of FIG. 23 consists of two components: (a) a holder 197 and (b) the sterile sheath 175 itself. The sterile sheath 175 is attached to and wrapped around the holder 197 (FIG. 23A). The sheath assembly 195 is preferably packaged together with the single-use scope 131 in a pre-sterilized tray. The cap 197 has features or threads that allow the cap 197 to be mechanically easily locked and unlocked onto the proximal end 186 of the handle 132.

[0101] A user wearing a sterilized glove extends one hand into the sterilization tray to take out the sterilized sheath assembly 195, and then locks the cap 197 onto the proximal end 186 of the handle 132 (Figure 23B). The user can continue to extend the sheath over the handle until a sufficient portion of the handle body is covered by the sheath. As a result, by holding onto the covered portion of the handle, the user can remove the handle with one hand and separate it from the docking station 177 (Figure 23C). Next, the user extends the other hand (also wearing sterilized gloves) into the sterilization tray to take out the sterilized scope 131 and connects it onto the distal end 178 of the reusable handle 132 (in the proper orientation) by simply pushing the sterilized scope 131 into the distal end 178 of the non-sterilized handle as shown in Figure 23D. Then, by firmly grasping the sterilized scope side of the connected assembly (scope and handle) with one hand, the user uses the other hand (holding onto the handle at the portion covered by the sheath 175) to further extend the end rubber 198 of the sterilized sheath further distally along the handle and push it past the rounded annular ridge 196 of the sterilized scope as shown in Figure 23E. At this point, by wearing the only set of gloves on each hand, the user covers the entire body of the non-sterilized reusable handle 132 with the sterilized sheath assembly 195 and locks the sterilized sheath 175 onto the sterilized scope so that the sheath cannot come off during use of the completed assembly 130. Thus, essentially, as shown in Figure 23E, the sterilization barrier completely covers the reusable non-sterilized scope.

[0102] As part of this embodiment, it is intended that the raised portion 196 of the fixed part of the scope 136 be slightly larger in size than the width of the handle and the nominal size of the end rubber 198. At the same time, the elasticity of the end rubber 198 is such that it can be pushed and stretched with a small force towards the other side of the raised portion 196, so that the end rubber 198 remains in place as shown in FIG. 23E during use, preventing the sterilization sheath 175 from unwinding over the raised portion 196 and exposing the body of the non-sterile handle 132. The sterilization sheath 175 is preferably a thin transparent plastic such that features of the handle 132 (such as illuminated indicators or buttons) that need to be visible to the user can continue to be seen through the sheath.

[0103] At the end of this procedure, the user can unwind the end rubber-sheath 198 over the raised portion 196, then further unwind and remove the sheath 175 from the handle, unlock the cap 197, and discard the entire sheath assembly 195. Then, by pressing or sliding the lever 171 (FIG. 21B), the user can unlock the used scope and also discard it. At this point, the reusable handle is free and can be placed back on the charger 177 as shown in FIG. 22E to charge the battery and prepare for the next procedure.

[0104] In another example of a sterile cover that covers the wireless reusable handle 131, the sterile sheath assembly 195 may be made of a more rigid one-piece plastic cover (or two or more pieces) that can completely enclose the reusable scope handle 132. In this case, the assembly 195 would be closer to a sterile cover than a sterile sheath. Such a cover assembly would surround the reusable handle, flare distally, and attach over features such as the raised portion 196 or some other feature on the fixed portion 136 of the disposable scope 131. A transparent qualification window on such a plastic sterile cover would allow access through the window to buttons (for mechanical actuation) and indicator lights (for viewing).

[0105] In this case, the reusable handle 132 may be wired to the image processing hardware, and then the sterile sheath assembly 195 may be placed over it from the opposite direction on the handle (with the distal end inverted proximally to the handle). In this case, the docking station 177 may be just a passive mechanical holder that holds the handle 132 in an orientation similar to that depicted in FIG. 22B (with the distal end 178 of the handle 132 facing up), while allowing an electrical cable exiting from the proximal end 186 of the handle (with the distal end 178 of the handle remaining facing up) to pass through to the docking station. In this example, the holder 197 of the sterile sheath assembly 195 is already attached on the fixed portion 136 of the sterile scope, with the end rubber 198 of the sheath assembly facing towards the proximal end of the sterile scope 131, and the sterile sheath assembly 195 may be slightly different from that depicted in FIGS. 23A - 23E.

[0106] Next, the user grasps the sterile scope with one hand (while wearing a sterile glove) and presses the sterile scope onto the distal end of the handle without touching the non-sterile handle until the sterile scope locks in place, thereby locking the sterile scope onto the proximal end 178 of the handle. Next, the sheath 175 is extended onto the handle until a sufficient length of the handle is covered by the sheath, such that the handle can be removed with one hand and separated from the holder 177. Next, the other hand, also wearing a sterile glove, can continue to extend the sheath 175 towards the proximal end 186 of the handle until the entire handle 132 is covered. In this embodiment, the user will need to continue to spread the sterile sheath all the way to the image processing connection 11 over the entire length of the electrical cable 14 connected to the proximal end of the handle.

[0107] In previous embodiments, the orientation of the wireless reusable scope on the docking station 177 during charging was such that its proximal end was in contact with the charger. Accordingly, the charging pins 192 were located on the proximal end 186 of the handle. The reason for this is that the distal end 178 of the handle already includes several electro-optical interconnects with the disposable scope 131 and other locking and mating features 179, 173 with the scope. The location of the charging pins on that end can make assembly more cumbersome, but it allows for charging of the handle 132 at its distal end.

[0108] In this embodiment depicted in FIGS. 24A and 24B, as shown in FIG. 24A, since the charging pogo pin 192 is on the distal end 178 of the reusable 132 and is in a further proper location, when the handle 132 is stationary within the docking station 177, as in FIG. 24B, the pogo pin 192 makes proper contact with its mating partner 189 on the docking station. The latch 179 that locks onto the scope to ensure proper orientation of the scope, and the asymmetric feature 173 are still present on the distal end 178 of the reusable handle together with the pass-through PCB 152 and the light output window 174. In this embodiment, since the scope charges downward, as in the case of the configuration depicted in FIG. 22B, there is no need for a dust cover during charging. Since the scope is charging in the same orientation as in FIG. 23A, covering the sterilization sheath assembly 197 is the same as previously described. Clearly in this embodiment, the location of the connector 192 in FIGS. 21A and C has to be moved to the distal end 178 of the handle.

[0109] In yet another embodiment shown in FIGS. 25A and B, the removable lever 137 in FIGS. 13 and 14 can be replaced by an oversized feature 168 in the circumferential direction on the distal rotatable scope cavity 135. In this embodiment of the distal rotatable scope cavity 135, the outer surface of the outer circumferential feature 168 may appear similar to that of the outer surface of component 36 in FIG. 4, for example. The oversized feature 168 should preferably be larger in diameter than the outer diameter of the annular ridge 196 (see FIG. 25A) such that a user can easily access the feature 168 of the ridge 196 with one hand (while gripping the handle) and rotate 135. Further asymmetry on the outer surface 168 of 135 may be added in the form of small shark fins 161. With respect to the viewing angle of the scope, the shark fins 161 are arranged in the same radial location as the removable lever 137 would have been, i.e., in an orientation diametrically opposed. In this way, the user can feel the lateral viewing orientation with a finger (by contacting the shark fins 161) without having to look down at the scope. All other features of this embodiment can be the same as the embodiment shown in FIG. 20A.

[0110] In this embodiment, the sterilization sheath may be used as previously described.

[0111] FIGS. 26 through 28 show another embodiment for the sterilization protection of the instrument of the present invention in use. In FIG. 26, which is a schematic cross-sectional view, the distal end of the instrument, including the shaft 20 and the shaft holding component or needle base 38, is disposable and separable from the handles 16, 36. A portion 36 of the handle can rotate in the shown plane of rotation 210. At the distal end, a plastic hood or shell 212 is fixed to the shaft holding component 38 and can rotate therewith. The shaft holding component 38 includes an LED 58 along with the optical fiber shown at 28 in the drawing. Electrical contacts are shown at 214 and heat sink transfer pads are shown at 215.

[0112] On the right side of the drawing, handles 16, 36 (which have a wireless version of the electronic circuit contained within this handle) are present within the proximal hood or shell 216. Handles 16, 36 (wireless) are engaged within the proximal shell 216 by means such as friction, snap-in, or twist-lock engagement. The orientation of the rotating portion 36 of the handle with respect to the proximal shell is defined by pins or introduction features or other features. The snap-in clip is shown at 218 within the proximal shaft of the drawing. This holds the handle within the proximal shell 216 and allows it to be removed from the proximal shell 216. Other forms of clips or friction engagement may be used.

[0113] As described above, the rotation of the conical piece 36 is shown in the plane of rotation 210 of the figure. Further, the distal shell or hood 212 is snap-fitted integrally with the proximal hood or shell 216 via respective snap-tabs or joints 220 thereon, which preferably results in rotation of the distal shell 212 (including the shaft retainer piece 38) relative to the proximal shell 216. However, the two shells may be fixed without relative rotation, but the needle and shaft retainer piece 38 may be made rotatable (along with the conical piece 36). A radial lever (not shown) may be included on the exposed needle hub for this purpose.

[0114] However, before connecting the two shell pieces together, first the conical piece 36 of the handle is snap-fitted integrally with the shaft holding component 38. This may be via the connection discussed above and realizes the electrical connection made between the two sides via the electrical contacts 214 and thermal contacts 215 and similar contacts on the conical piece 36. After its internal connections are made, the proximal shell 216 is snap-fitted onto the distal shell 212.

[0115] FIG. 26 shows an on / off switch 222 on the outside of the proximal shell 216 for making proper contact with a conductor on the handle to operate the device via the outer shell 216. With all components fastened, the needle 20 may be rotated by the user by manually turning the distal hood or shell 212 relative to the proximal shell 216, and this will result in rotation in the plane of rotation 210 within the handle.

[0116] FIGS. 27 and 28 further illustrate the sterile use of the device. In FIG. 27, the handles 16, 36 are docked within a charging stand 224. The drawings show shaft retaining pieces that are held within the distal outer shell 212 and lowered over what appears to be the upper (distal) end of the handle, and these are assembled integrally using snap-fit attachments or "snapped" together. The outer shell 212 and the needle 220 are removed from a sterile wrapper or container and sterilized.

[0117] Next, the assembly of the distal outer shell 212 and the handle, which is fastened to the shaft retaining piece 38, is lifted from the charging station 224 and lowered into place on the proximal outer shell 216 as shown, thereby inserting the handle body 16 downwardly into the gripping mechanism 218 of the shell 216. Similar to the distal shell 212, the proximal shell is sterilized and the wrapping is removed. Further, the outer shells 212 and 216 are "snapped" together integrally, and their connection can be released later. In this way, the sterile needle shaft 20 and the sterile outer shells 212 and 216 are exposed, fastened to the reusable handle 16, and integrally connected in a rotatable manner while still accommodating the reusable handles 16, 36 inside. This avoids any need for sterilization of the reusable handle. At the end of the procedure using the endoscope of the present invention, the shells are separated from each other by a quick release device, and as seen in the upper part of FIG. 28, the distal shell 212 and the handles 16, 36 remain essentially as they are. The snap integral connection between the needle retaining piece 38 and the conical piece 36 (FIG. 26) is accessible to the user, and the separation of the components 38 and 36 (i.e., the separation of the piece 38 from the handle) can be achieved by pressing an appropriate final release mechanism (not shown). Not only the components on the left side of FIG. 26 but also the proximal outer shell 216 are discarded, while the handles 16, 36 are retained and reused.

[0118] At the end of the procedure, a logical and easy step of removing the disposable shell, such as initially removing the rear (proximal 216) disposable item by simply applying manual force, is performed. Next, since the front (distal 212) disposable item and the reusable handle remain in contact, in the following steps, they are disengaged or discarded either via the release mechanism discussed or by applying force to the front disposable item (the shell 212 including the piece 38). In a different embodiment shown schematically in FIG. 28A, the rear disposable item may simply be a cap 226 that can be rotated or snap-fitted onto a much larger front disposable piece 228 that may further include an on / off button and an operation button. This requires sliding the reusable handles 16, 36 into its longer front disposable piece 228 and then simply adding the rear cap 226 and attaching it to the rear of the main rear shaft body 229, which is rotatably connected at its front (distal) end to the front (distal) shaft 212. Either the rear cap 226 or the main rear shaft body 229 is attached to the reusable handle portion 16. The front shell with the needle 20 can rotate relative to the rear shell 229 and the cap 226. This configuration keeps the reusable items safely intact, which results in advantageous ease of use.

[0119] In one embodiment of the present invention, the portable endoscope device is cordless and includes a rechargeable battery and a wireless connection from the device to an image processor and monitor, including image data. The protocol for transmission of video and general data from the portable endoscope to the base unit can be point-to-point data transfer such as WiFi or Bluetooth that transfers compressed or uncompressed video data, or direct WiFi. The portable endoscope can be easily handheld due to its size. Further, the scope may be used with one-handed operation and manipulation. The base unit (11 and 12 in FIG. 1) may specifically be built-in hardware, firmware, and software such as an embedded Linux® industrial-level tablet, or a consumer-grade iOS operating system tablet from Apple, Inc. of Cupertino, California, or an Android® tablet manufactured by Samsung of Korea. The tablet and / or handheld can further communicate with an individual display monitor or multiple displays that display video, images, data, or other relevant information, if desired.

[0120] One embodiment (not shown) further relates to a heat sink for an LED that serves as a support member for a handle. The LED and the heat sink are interfaced in a limited manner with the front tip of an endoscope, which can be in the form of a long needle that includes a camera at its distal end, while the heat sink is at the proximal end. The rotation detection potentiometer may be in the form of a knob rotation potentiometer that includes a non-rotating base and is mounted on the proximal end of the heat sink. The base of the potentiometer may be fixed to a heat sink that can be cylindrical (such as 44 in FIGS. 5 and 5A), so that the knob is on the long axis of the heat sink cylinder, pointing towards the proximal end of the entire handle, i.e., towards the operator, while the patient is at the most distal end of this axis. Thus, the front rotating member of the handle is composed of a camera including optical components, a tip, a needle, a fiber, an LED, a heat sink, and a potentiometer. In that case, the rear (non-rotating) part of the handle is mounted on the potentiometer / trim resistor knob to achieve relative rotation between the trim resistor knob and the front rotating member of the handle. In another example, the potentiometer including the knob can be inverted, where the knob can be attached with a suitable adapter on the proximal end of the heat sink (within the front rotatable component), and here, the potentiometer base is attached to the rear part of the handle. The front and rear parts rotate relative to each other, resulting in rotation between the two parts of the potentiometer. Depending on the selection of the above-described configuration, the wire connected to the potentiometer base that supplies voltage and measures the voltage correlated with the rotation angle is connected to the PCB board and may be twisted during rotation. Thus, the wire can further provide rotation limits for rotation on either side, for example, with respect to the location of buttons or other features on the handle. More preferably, a separate feature for limiting rotation may be used, and the wire can be made longer so that it is never tautly pulled.One example of such a potentiometer can be the PN5A1A-B28-A15L sold from a website including the description of "10k Ohm Gang Linear Panel Mount Potentiometer None Kierros Cermet 2W Solder Lug" from Bourns Inc. and Digikey Inc.

[0121] Another embodiment would have a potentiometer with holes instead of a potentiometer with a knob. FIGS. 5 and 5A show such an embodiment including a potentiometer 50 with holes, in which a heat sink feature or a separate adapter contacts the potentiometer through the holes and allows rotation of the internal cylindrical body of the potentiometer relative to the fixed external body of the potentiometer. Such a potentiometer can be, for example, the part number PN3382H-1-103 sold from a website including the description of "Resistive Sensor Rotary Position Hole for Shaft PC Pin" from Bourns Inc. and Digikey Inc.

[0122] Figures 28B and 28C show another embodiment which may have reusable code, i.e., is not necessarily code - less, and introduces a disposable sterilization barrier 230 over both the rotating and fixed portions of a reusable scope handle. In this system, the front scope needle 20 with a shaft retainer is disposable, but the remainder of the handle is still reusable. The handle may still require a cord 231 to connect to the system, even though WiFi may be enabled, and that cord need not necessarily be sterilized during the procedure. This embodiment includes a continuous bag or flexible material 230 that is segmented by, for example, plastic bands or snap - fit pieces as shown at 232 and 234 into two or more handle areas. As shown in Figure 28B, before the disposable scope component is attached to the reusable handle, the disposable bag is integrated with the disposable front needle and mounting piece of the scope and is first folded or wrapped. After attachment, the bag 230 is first opened or spread over the rotating portion 36 of the reusable handle and then opened or spread over the proximal fixed portion. There is another snap - fit fixture at that location (or the band 234 can be moved back to its original position) that will hold in place the portion of the bag that extends over the rotating piece and part of the fixed portion of the handle. Then the remainder of the bag is opened to completely cover the remainder of the original handle and further the cable 231 up to the connection to the image processor 11 or monitor 12, which is a non - sterilized system for data acquisition and / or scope control. The portion of the sterilization barrier material 230 that extends over the rotating components of the handle is designed such that appropriate extra material is provided to allow rotation of the two parts relative to each other without being restricted by the sterilization barrier material or bag 230. This is achieved further by means of a gathering or folding of the material or by maintaining a loose material appropriate for multiple rotations. The material is mainly in a cylindrical tube shape or a similar shape, but may be formed as desired. In that sense, the inner diameter of the disposable tube is as important a consideration as the extended length of the tube.This is because both define the limit of rotation of the fixed part and the rotating part of the handle with respect to each other. If the inner diameter is as tight as the handle and it is tightly wound without any further slack in length, the material cannot stretch, thus preventing rotation. Even if the length of the tube is short, if its inner diameter is very large, rotation can occur up to a certain angle without the material stretching. Discarding the bag and the retainer ring or snap or other fixture at one, two, or more locations of the handle is done by removing the bag by winding it up from the cord end to the handle, and then the disposable tip can be removed. Alternatively, a separate ring is inserted over the scope needle with a disposable sterilization barrier (even if all other parts of the scope are reusable), and then wound and snap-fitted as described above. During disposal, this ring is removed first or last, and the bag is wound around the reusable scope.

[0123] Figure 29 is a flow diagram showing a routine for reorientation of a video image during rotation of a shaft / needle 20 with a lateral view scope of the present invention. For each block 260, the angled view scope of the present invention is plugged into a tablet or other monitor shown at 11 and 12 in the schematic of FIG. 1, and the image processor is shown at 11. At 262, the programming reads an image frame from the camera sensor. This is of course a rapid iterative process.

[0124] Shown at 264 is the rotation of the tip-on-tip instrument shaft (including the optical components and camera) by the surgeon or technician during the procedure. The potentiometer (or magnetometer) signal generated as described above is read by programming as described in block 266. At decision block 268, the system verifies that the signal voltage from the potentiometer is within range, i.e., within the range that would indicate a valid angle of rotation. If not within range, further decision block 270 checks for an operation of mechanical stop. As described in blocks 272 and 274, an error is indicated in either event.

[0125] Assuming that the signal voltage from the potentiometer is within the range, the voltage signal is converted into a rotation angle as described in block 276. In block 278, image frame data is received in the same way as the rotation angle from block 276. In response to the data from block 276, the image is rotated in the FPGA (Field Programmable Gate Array), which is performed within the image processing program. The image rotation may further be performed in other suitable hardware such as a system-on-module including the FPGA and / or CPU (Computer Calculation Processing Unit) processor(s). In block 280, aliasing and other image processing filters are applied. A circular mask is applied in software (block 282), and as a result, it can be displayed as a round ring that touches the sides of the rectangular image produced by the rectangular optical sensor (CMOS, chip-on-tip). An indicator for specifying the angular deviation from the reference position is further shown on the circular mask as shown in block 284 and can move around the periphery of the mask to show the angle of the scope tip relative to the reference angle. In most cases, even if the image on the display is always referenced and corrected with respect to the patient position and anatomical tissue, the reference angle is calibrated to match the horizontal or vertical of the patient orthonormal system to give the physician real-time feedback on where the tip actually is located. This feature of masking the area of the rectangular image to show only the circular image is optional. The rotation angle indicator may be optional or may be applied to the periphery of the rectangular image itself without performing the circular mask as in block 286. This provides the advantage of a larger field of view. The saving of the video or image in either the rotated or pure format described in blocks 288 and 290 is optional in this system. This affects the firmware selection regarding where the rotation is performed and how it is displayed.

[0126] Figures 30, 31, and 32 illustrate a simple example of the image rotation correction feature of the present invention and depict one-handed operation of the scope according to its configuration. In these drawings, the scope 10 of the present invention is held in the user's hand, and the shaft 20 is shown near a sheet of notepaper P on which letters from A to H are written as an example. While the user holds the main body 16 of the handle between several fingers and the thumb T, in this particular example, the index, forefinger, and middle finger engage the rotating shark fin 161 as discussed earlier. The fin 161 is a grippable protrusion that is ergonomically positioned to enable one-handed operation of the scope by being able to identify its position by tactile sensing for simultaneously holding the scope and rotating the needle and its side view.

[0127] In Figure 30, the user holds the needle including the camera and optical components in a position where the right side of the letter range is displayed as EFGH. The image is shown on a screen 12 which may be a tablet computer. The scope needle 20 is rotated clockwise while maintaining its 30° viewing angle, looking right on the paper P. The illumination can be seen almost to the right on the paper according to the viewing angle.

[0128] In Figure 31, the next figure, the user rotates the tip of the scope counterclockwise to approximately the middle position with a centered view but angled upward. The illumination is moved to around the center of the small piece of paper P, and the image shows DEFG. This rotation of the angled scope will lower the captured letters to a lower position on the monitor, but here it is assumed that the user can further adjust the pitch of the needle shaft 20 so that the user essentially keeps the image of the letters at the middle height of the monitor. As shown on the monitor, the image of the letters is maintained in the proper orientation, which is the same orientation as in Figure 30, to provide continuity of visual orientation for the user. The image processor functions continuously to perform this correction.

[0129] In FIG. 32, the user rotates the tip of the scope further counterclockwise to move the image further to the left, allowing more of the first characters in this sequence to be visible. The illumination is moving to the left on the paper P. Further, the image of the characters is corrected to an orientation in which it is stably displayed.

[0130] Rotation of the tip of the scope effectively provides a much wider viewing angle in all directions: left, right, up, and down. In the examples shown in FIGS. 30 to 32, the pitch of the instrument is manipulated to keep the imaged proximal characters at an intermediate height. However, if the scope is inhibited by anatomical tissue, pitch adjustment may not be possible. Further, since the user often wants to examine more tissue not only left and right but also up and down, the height position of the tissue features will change as the scope rotates.

[0131] From these figures, not only the composition and size of the scope 10 relative to a human hand, but also the ease of use when rotating the needle shaft using one or two fingers (including the angular view) is also understood. The rotation is easy, well-controlled, and comfortable, while the body of the scope is held in the palm of the hand or between the thumb and the smaller fingers.

[0132] As described above, the small video scope of the present invention is ergonomically designed to be operated and rotated with one hand of the user. The composition is such that the main body of the device is held in the palm of the hand or between the first two fingers of the palm, and the rotation fins near the distal end of the handle can be easily operated with one or two fingers.

[0133] One-handed operation of a device is known in the art. One example is pistol operation, where there is an ergonomics that holding a pistol grip in the palm of the hand and operating the trigger with a finger leads to size constraints related to the average human hand. These principles apply to the present invention. The composition and size of the scope of the present invention are uniquely adapted for one-handed operation.

[0134] Exemplary sizes of the device are as follows. Overall length of the handle (from the nose piece to the cord): 12 cm (range from about 10 to 14 cm). Distance from the gripping area of the palm to the fin tip: 5 to 7 cm (about 4 to 8 cm, or 2 to 10 cm). Location of the center of the control button(s) relative to the back of the rear cap: 5 cm (range may be 3 - 9 cm, and the best range is within 5 - 8 cm). Location of the button(s) relative to the fin tip: 2 cm (range 1 cm - 5 cm). Maximum width / diameter of the body / rear cap: 5 cm (range 3 - 8 cm). Diameter of the rotating piece: maximum 4 cm and minimum 2 cm. Maximum range about 2 - 6 cm and minimum range about 1 - 5 cm. Fin protrusion height 3 mm (range 2 mm - 10 mm and in some cases 5 mm - 15 mm or even larger). The fins are removable and may be magnetically held to the conical piece 36 or may be clip - fastened. Fin angle: 30 degrees, range from 25 degrees to 60 degrees, 30 - 45 degrees is optimal. Weight of the handle of the scope: reasonable for one - hand gripping, preferably about 113 - 198 grams (4 - 7 ounces).

[0135] The above - mentioned preferred embodiments illustrate the principles of the present invention and do not limit its scope. Other embodiments, and variations of these preferred embodiments, should be apparent to those skilled in the art and can be made without departing from the spirit and scope of the present invention as defined in the following claims.

Claims

1. A medical endoscope system for real-time visualization of a patient's internal tissue or cavity, comprising an endoscope device having a distal end for insertion into tissue and a proximal end including a handle, wherein the distal end has an imaging sensor and imaging optics for generating a digital video image, and the imaging sensor is connected to the handle for transmission of digital image data to a remotely connected image processor from the endoscope device, wherein the needle is rotatable along a longitudinal axis relative to a base portion of the handle, wherein the medical endoscope system further comprises a fluid delivery cannula fitted over the needle, with a Luer port connected to the cannula for receiving fluid and delivering the fluid through the cannula, essentially exiting the cannula at the distal end of the needle, and the Luer port is rotatable about the longitudinal axis independently of the cannula and the needle, wherein the image processor includes image correction means for maintaining a video image with an upright and stable image orientation when displayed despite rotation of the needle, wherein the medical endoscope system further comprises a video monitor connected to the image processor for displaying in real time a video image of the patient's tissue or cavity from the camera, the video image being corrected with respect to rotational orientation and displaying a stable image orientation while the needle is in a rotated state and during use of the endoscope device. A medical endoscope system.

2. The medical endoscope system according to claim 1, wherein when the needle is rotated, the imaging sensor and the imaging optics are angled at an acute angle from the longitudinal axis so as to generate a side-view video image.

3. The medical endoscope system according to claim 1, wherein the needle forms part of a disposable component including a needle base permanently attached to the proximal end of the needle and releasably connectable to the handle.

4. The handle includes a distal end piece that is rotatable relative to a proximal body portion of the handle that forms a part of the base portion. On the rotatable piece, there are provided radially projecting portions that can be manually engaged for rotation of the needle during use of the endoscope system. The disposable component can be releasably connected to the distal end piece of the handle. The medical endoscope system according to claim 3.

5. The body has a distal end piece, a body proximal to the distal end piece, and a rear cap as a proximal component. The distal end piece is snap integrally connected to the body, and the body is snap integrally connected to the rear cap without using a screw. The medical endoscope system according to claim 1.

6. The medical endoscope according to claim 5, wherein the distal end piece is a rotatable component of the handle.

7. The medical endoscope system according to claim 1, wherein the imaging sensor is connected to the image processor by a wireless connection.

8. The distal end of the needle includes an illumination device, and the illumination device has a distal end of an optical fiber that conveys light from a proximal light source within the endoscope device. The medical endoscope system according to claim 1.

9. The medical endoscope system according to claim 8, wherein the light source is an LED positioned within a needle base fastened to the needle.

10. The medical endoscope system according to claim 9, including a heat sink in contact with the LED for sucking in heat from the LED.

11. The medical endoscope system according to claim 1, wherein the distal end of the needle includes an illumination device having one or more LEDs.

12. Including a rotatable transducer operable between the handle and the needle, the transducer having a potentiometer, magnetometer, or encoder that monitors the rotational position of the needle relative to the handle and generates a signal sent to image correction means. The medical endoscope system according to claim 1.

13. The medical endoscope according to claim 12, wherein the potentiometer, magnetometer, or encoder driven by a gear mechanism from the rotation axis of the needle is disposed off-axis from the rotation axis of the needle.

14. A medical endoscope system for real-time visualization of a patient's internal tissues or cavities A medical endoscope system comprising a needle having a distal end for insertion into tissue and an endoscopic device having a proximal end including a handle, wherein the distal end has an imaging sensor and imaging optics for generating digital video images, and the imaging sensor is connected for transmission of digital image data to a connected image processor, wherein the needle is rotatable along a longitudinal axis relative to the handle, and includes a needle base or scope cavity permanently attached to the needle, the needle base being rotatably connected to a fixed element, the fixed element being removably attached to the handle, wherein the medical endoscope system further comprises, A medical endoscope system comprising a video monitor connected to the image processor for displaying in real time a video image of a patient's tissue or cavity from the image sensor.

15. The medical endoscope system according to claim 14, further comprising a radially extending lever on the needle base or scope cavity, the lever being positioned to be manually operated when the handle is gripped to rotate the needle base and the needle relative to the handle.

16. The medical endoscope system according to claim 14, wherein the handle includes the image processor.

17. The medical endoscope system according to claim 16, wherein the handle and the image processor include wireless connection means for transmitting image data from the imaging sensor to the image processor, and the handle includes a battery for supplying power to the fixed element, the needle base, and the needle.

18. The medical endoscope system according to claim 14, wherein the needle base or the fixed element includes an electronic circuit for receiving the digital image data, the electronic circuit including a wireless transmitter for wirelessly sending the data to the image processor, and the handle includes a battery for supplying power to the needle and the electronic circuit when the fixed element is attached to the handle.

19. The medical endoscope system according to claim 14, wherein the image processor includes image correction means for maintaining a video image in an upright and stable image orientation when displayed despite rotation of the needle.

20. The medical endoscope system according to claim 14, wherein the image correction means includes a rotational sensing transducer between the needle base and the fixed element.

21. The medical endoscope system according to claim 14, further comprising an LED present within the handle and an optical fiber within the needle, wherein when the fixed element is coupled to the handle, the LED is optionally communicable with the optical fiber of the needle.

22. The medical endoscope system according to claim 14, wherein the needle includes illumination realized by at least one LED positioned within the distal end of the needle.

23. The medical endoscope system according to claim 14, further comprising a sealing device for sterilization sealing of the reusable handle, wherein when the fixed element is coupled to the handle, the sealing device is connectable to the fixed element of the needle.

24. The medical endoscope system according to claim 14, combined with a fluid delivery cannula fitted over the needle, wherein a luer port is connected to the cannula to receive fluid and deliver the fluid through the cannula, exiting the cannula essentially at the distal end of the needle, and the luer port is rotatable about a longitudinal axis independently of the cannula and the needle.

25. The medical endoscope system according to claim 1, combined with a fluid delivery cannula fitted over the needle, comprising a luer port for receiving fluid and delivering the fluid through the cannula, exiting the cannula essentially at the distal end of the needle, and the luer port is rotatable about a longitudinal axis independently of the cannula and the needle.

26. A medical endoscope system for real-time visualization of a patient's internal tissue or cavity, comprising a needle having a distal end for insertion into tissue and an endoscope device having a proximal end including a handle, wherein the distal end has a chip-on-tip imaging sensor and imaging optics for generating a digital video image, and the imaging sensor is connected for transmission of digital image data from the endoscope device to a remote image processor. the needle is rotatable along a longitudinal axis relative to a base portion of the handle; the handle includes a rotatable distal end coupled to the needle, the rotatable distal end being rotatably coupled to the base portion of the handle and having a finger engagement element for rotating the handle relative to the base portion of the handle using a finger or thumb; the handle is configured to be grasped and manipulated with one hand such that the base portion is contacted by the palm, thumb and one or two fingers, or the thumb on the finger engagement element, the base portion having a diameter of about 6 cm or less, and the finger engagement element being about 2 to 10 cm distal to a proximal end of the base portion of the handle; the medical endoscope system further comprises a video monitor connected to the image processor for displaying in real time a video image of the patient's tissue or cavity from the imaging sensor, the video image being corrected with respect to rotational orientation and displaying a stable image orientation while the needle is in a rotated state and during use of the endoscopic device. **Claim 27** The medical endoscope system according to claim 26, wherein the image processor includes image correction means for maintaining a video image with an upright and stable image orientation when displayed despite rotation of the needle. **Claim 28** The medical endoscope system according to claim 26, wherein when the needle is rotated, the imaging sensor and the imaging optics are angled at an acute angle from the longitudinal axis to generate a side-view video image. **Claim 29** The medical endoscope system according to claim 26, wherein the handle has a distal end piece, a main body piece proximal to the distal end piece, and a rear cap as a proximal component, the distal end piece being snap integrally connected to the main body piece, and the main body piece being snap integrally connected to the rear cap without using screws or other metal fasteners. **Claim 30** The medical endoscope system according to claim 26, wherein the needle forms part of a disposable component including a needle base permanently attached to a proximal end of the needle and releasably connectable to the handle. **Claim 31** The handle includes a distal end piece that is rotatable relative to a proximal body portion of the handle that forms a part of the base portion, and the rotatable piece is provided with a radially projecting manual engagement for rotation of the needle during use of the endoscopic system. The disposable component can be releasably connected to the distal end piece of the handle. The medical endoscopic system according to claim 30.

32. The medical endoscopic system according to claim 31, wherein the radially projecting portion includes a finger or thumb engaging fin.

33. The medical endoscopic system according to claim 30, wherein the needle base is separable from the handle by manipulation of one or more levers or latches on the outer surface of the handle.

34. The medical endoscope according to claim 29, wherein the distal end piece is a rotatable portion of the handle.

35. The distal end of the needle includes an illumination device, and the illumination device has a tip of an optical fiber that conveys light from a proximal light source within the endoscopic device. The medical endoscopic system according to claim 26.

36. The medical endoscopic system according to claim 35, wherein the light source is an LED positioned within a needle base fastened to the needle.

37. The medical endoscopic system according to claim 36, including a heat sink in contact with the LED for absorbing heat from the LED.

38. The medical endoscopic system according to claim 26, including a rotatable transducer operable between the handle and the needle, and the transducer has a potentiometer that monitors the rotational position of the needle relative to the handle and generates a signal sent to image correction means.

39. The medical endoscopic system according to claim 26, wherein the needle and the connected needle base are removable and disposable from the handle, and the handle is reusable.

40. The medical endoscopic system according to claim 39, including a needle base or scope cavity permanently fastened to the needle, the scope cavity being rotatably connected to a fixed element, and the fixed element being removably connected and non-rotatable to the base portion of the handle.

41. The needle forms part of a disposable component including a needle base permanently attached to the proximal end of the needle and being releasably connectable to the handle. The endoscopic device is wirelessly connected to the image processor, a battery is included within the handle, and further, the medical endoscopic system includes a charging base adapted to rest on a surface and receive the proximal end of the handle for charging the battery when the body is placed on the charging base, the medical endoscopic system according to claim 26.

42. A medical endoscopic system for real-time visualization of a patient's internal tissues or cavities, comprising an endoscopic device having a distal end including a needle for insertion into tissue and a proximal end including a handle, the needle having a distal tip including an imaging sensor and imaging optics for generating a digital video image, the imaging sensor being connected to the handle for transmission of digital image data to a remotely connected image processor from the endoscopic device, the needle being rotatable along a longitudinal axis relative to the base portion of the handle, the image processor including image correction means for maintaining a video image in an upright and stable image orientation when displayed despite rotation of the needle, the medical endoscopic system further comprising a video monitor connected to the image processor for displaying in real-time a video image of the patient's tissue or cavity from the imaging sensor, the video image being corrected with respect to rotational orientation and displaying a stable image orientation while the needle is in a rotating state and during use of the endoscopic device, the endoscopic device being separable into a reusable portion including the base portion of the handle and a disposable portion including the needle and a needle base fixed to the proximal end of the needle, the medical endoscopic system further comprising a proximal disposable shell surrounding and attached to the handle for maintaining the sterility of the handle during use, A distal disposable shell that surrounds the needle base and is attached to the needle base, the proximal disposable shell and the distal disposable shell being snap-fitted together to form a complete shell, attachment means for mechanically and electrically coupling the needle base to the handle, and means for causing rotation of the needle base and the needle from the outer surface of the complete shell during use of the endoscopic device. A medical endoscope system comprising a distal disposable shell.

43. The means for causing rotation includes a rotatable connection between the distal disposable shell and the proximal disposable shell such that rotation of the distal disposable shell is effective to rotate the needle when the distal disposable shell and the proximal disposable shell are snap-fitted together. The medical endoscope system according to claim 42.

44. The medical endoscope is combined with a charging station, the handle is wirelessly connectable to the image processor, the handle includes a rechargeable battery, the handle is removable from the proximal disposable shell so as to be received within the charging station for charging, and the distal disposable shell attached to the needle and the needle base can be fastened to the handle by a snap-integral connection without the need for manual contact with the handle while on the charging station, whereby after the distal disposable shell including the needle and the needle base is fastened to the handle, the handle can be inserted into the proximal disposable shell, and then the proximal and distal disposable shells can be snap-fitted together. The medical endoscope according to claim 42.

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