Endoscope and method of using the same
By designing an endoscopic system with a reconfigurable channel and rotating axis, the problems of limited size of the hysteroscope working channel and inconvenient electrical connection of the rotating axis were solved, the flexibility and stability of large tool introduction and fluid delivery were achieved, and the convenience and efficiency of surgical operations were improved.
Patent Information
- Application Number
- CN201980070103.6
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2018-08-27
- Filing Date
- 2019-08-27
- Publication Date
- 2025-09-12
- Estimated Expiration
- 2039-08-27
AI Technical Summary
The working channel size of existing hysteroscopes is limited by the patient's cervix, making it difficult to adapt to larger interventional tools and fluid delivery requirements. At the same time, there are inconveniences in the electrical connection and fluid flow system of the rotating axis.
A reconfigurable endoscope shaft was designed, in which the channel can switch between retracted and non-retracted shapes. The rotating axis can rotate 180° around the handle, and the flexible electrical leads and fluid channels remain sealed during rotation. Combined with image sensors and fluid management systems, flexible introduction and extraction of tools and fluids can be achieved.
It achieves the smooth introduction of larger tools and continuous delivery of fluids, the stability of electrical connections and the flexible orientation of image sensors, improving the convenience and efficiency of surgical operations.
Smart Images

Figure CN114126473B_ABST
Abstract
Description
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS
[0002] This application is a non-provisional application of U.S. Provisional Application No. 62 / 723,393, filed on August 27, 2018, the entire contents of which are incorporated by reference. Background of the Invention
[0003] 1. Field of the Invention
[0004] The present invention relates generally to medical devices and methods. More particularly, the present invention relates to endoscopic systems suitable for hysterectomy and other purposes.
[0005] The endoscopic system of the present invention for hysterectomy generally includes a base station having an image display, a disposable endoscope component having an image sensor, a reusable handle component connected to an image processor in the base station, and a fluid management system integrated with the base station and handle component. The endoscope component and reusable handle are generally referred to as a hysteroscope.
[0006] Of particular interest to the present invention are hysteroscopes and other endoscopes that provide for the introduction of interventional tools through a working channel in the shaft of the scope.The size of the working channel of a hysteroscope is limited by the need to introduce at least the distal portion of the shaft through the patient's cervix.
[0007] Of additional interest to the present invention is that the hysteroscope may have a shaft that is rotatable relative to the handle, and this shaft will typically carry a camera and light source that need to be connected externally through the handle.
[0008] Of still further interest to the present invention, the shaft of the rotatable hysteroscope may also deliver fluids through an inner lumen having an external port fixed in the handle.
[0009] For these reasons, it would be desirable to provide an improved hysteroscope that can accommodate the introduction of relatively large tools through a relatively low-profile shaft. It would also be desirable to provide an improved hysteroscope that can accommodate the attachment of a camera, light source, etc. to a rotatable shaft via a fixed handle. It would also be desirable to provide an improved hysteroscope that can accommodate the flow of fluid through a rotatable shaft coupled to a fixed handle. At least some of these objectives are achieved by the invention described below. 2. Background Technology
[0011] Hysteroscopic systems similar to the type shown herein are described in commonly owned, co-pending applications: 15 / 712,603; 15 / 836,460; 15 / 861,474; and 15 / 975,626, the entire disclosures of which are incorporated herein by reference. SUMMARY OF THE INVENTION
[0013] In a first aspect of the present invention, a hysteroscope or other endoscopic system includes a shaft having an outer diameter of the shaft, a distal shaft portion, a proximal shaft portion, and a longitudinal axis between the distal and proximal shaft portions. A handle is coupled to the proximal portion of the shaft, and an image sensor having a diagonal dimension is carried by the distal portion of the shaft. A channel extends through at least the distal shaft portion and has a channel diameter. A portion of the channel in the distal portion of the shaft is reconfigurable between a contracted shape or geometry and a non-contracted shape or geometry to accommodate tools introduced therethrough. Due to the reconfigurable nature of the distal portion of the channel, the combination of the diagonal dimension and the channel diameter can be greater than the outer diameter of the shaft. The handle will typically be removably coupled to the shaft, such that the handle is reusable and the shaft is disposable, but at least some aspects of the present invention will also be found in endoscopes that include a fixed handle-shaft structure.
[0014] In certain exemplary embodiments of the endoscope of the present invention, the diagonal dimension will be at least 50% of the outer diameter of the shaft, and typically at least 60% or more. In further exemplary embodiments, the channel diameter will also be at least 50% of the outer diameter of the shaft, and more typically at least 60% or more of the outer diameter of the shaft.
[0015] In other exemplary embodiments, the endoscope of the present invention will be arranged in a system further comprising a fluid inflow source for providing a fluid flow to an outlet in the distal portion of the shaft through an inflow channel in the shaft. Typically, such a system will further comprise a negative pressure source for providing a fluid outflow through an outflow channel in the shaft and an opening in the distal shaft portion. Further, the system may comprise a controller for controlling the fluid flow through the inflow channel and the outflow channel, and at least one actuator located in the handle for regulating the fluid inflow and the fluid outflow. For example, the controller may be configured with an algorithm for operating the fluid inflow source and the negative pressure source to maintain the fluid in the working space (e.g., the uterine cavity) within a set pressure range.
[0016] In a second aspect of the invention, a hysteroscope or other endoscope includes a handle having an interior, an axis, and an electrical connector secured to the handle. The shaft is removably or otherwise coupled to the handle and is configured to rotate (typically reversibly) about a longitudinal axis relative to the handle through an arc of approximately 180° or greater. An electronic image sensor is carried at a distal end of the shaft, and one or more electrical leads extend from the image sensor to an electrical connector in the handle. The electrical leads are flexible and have "slack" configured in the interior of the handle to accommodate rotation of the shaft. "Slack" means that the length of the electrical leads is greater than the distance between the electrical connector and the point of attachment of the electrical leads to the shaft, such that the shaft can be rotated without over-straining the electrical leads.
[0017] In further exemplary embodiments of the endoscope, the slack portion can be formed as any of a coiled structure, a spiral structure, a folded structure, a serpentine structure, or the like. In certain embodiments, one end of the slack portion is coupled to a rotating shaft assembly and extends around the axis of the rotating shaft assembly, and the slack portion is typically carried on a reel fixed to the shaft assembly. The reel is typically coaxial or coaxially aligned with the axis of the shaft so that when the shaft rotates, the reel can tighten or loosen the flexible electrical lead as needed. In certain examples, the electrical lead can include a flexible circuit.
[0018] In yet another exemplary embodiment of these endoscopes, the light emitter can be carried at the distal end of the shaft, and a second electrical lead can extend from the light emitter to a second electrical connector fixed in the handle. The second electrical lead is configured with a second slack portion to accommodate rotation of the shaft. The second slack portion can also be carried on the second reel and can include a flexible circuit.
[0019] In yet another aspect of the endoscope, a channel can be formed in the shaft, wherein a portion of the channel can be reconfigured between a collapsed shape and a non-collapsed shape to accommodate the introduction of a tool through the channel. As with the first endoscope embodiment described above, the combination of the diagonal dimension and the channel diameter will generally be greater than the outer diameter of the shaft. Other specific aspects of the reconfigurable channel described above relative to the previous embodiments can also be found in the endoscope of the second aspect of the present disclosure.
[0020] In a third aspect of the present invention, an endoscope includes a handle and an elongated shaft. The elongated shaft is mounted for rotation (typically reversible rotation) of at least 180° about a longitudinal axis of the handle. An electronic image sensor is carried near a distal end of the shaft, and electrical leads extend from the image sensor to the handle. The electrical leads are configured to coil and uncoil (wind and unwind) about the shaft as the shaft rotates in opposite directions about the longitudinal axis. In a specific embodiment of this third endoscope configuration, the electrical leads may include a flexible circuit, and at least a portion of the flexible circuit may have a cross-sectional area that is less than 5% of the cross-sectional area of the shaft assembly.
[0021] In a fourth aspect of the present invention, an endoscope includes a handle and an elongated shaft mounted for rotation at least 180° about the longitudinal axis of the handle. A flow channel extends through the shaft assembly to a port in the distal end of the shaft. The flow channel has a proximal channel portion fixed to the handle and a distal channel portion that rotates with the shaft. A fluid-tight housing between the proximal and distal channel portions is configured to provide a fluid-tight path through the channel portions throughout the entire rotational range of the shaft.
[0022] In a particular aspect of the fourth endoscope of the present invention, the rotating shaft may include an annular flow channel that rotates in the housing. The endoscope may further include a second flow channel extending through the handle and shaft assembly, wherein the second flow channel has a proximal channel portion fixed in the handle assembly and a distal channel portion that rotates in the shaft when the flow channel rotates in the housing.
[0023] The present disclosure also includes a method for orienting an image from an endoscope having an image sensor on a display. For example, the method may include providing an endoscope having a longitudinal axis and a distal image sensor, the distal image sensor providing an image on a display; providing at least one of an accelerometer and a gyroscope carried by the endoscope; and obtaining a signal from the at least one of the accelerometer and the gyroscope due to rotation of the endoscope relative to the longitudinal axis; and rotating the image on the display in response to the signal to correct the orientation to a selected configuration.
[0024] The selected configuration may include a configuration in which the image is upright, and wherein the rotating step includes electronically manipulating the image.
[0025] In a variation of the method, wherein the accelerometer is located on a rotating component within the housing of the endoscope, the method further includes rotating the distal image sensor independently of a handle of the endoscope and determining the rotation of the distal image sensor independent of the handle using the accelerometer.
[0026] The method may further include providing at least a second accelerometer, the second accelerometer carried on a handle of the endoscope, the method further including acquiring a signal from the second accelerometer and comparing the signal from at least one of the accelerometer and the second accelerometer.
[0027] Another variation of an endoscope includes an endoscope electrically coupled to an image display, the endoscope comprising an elongated shaft having a housing at a proximal end of the elongated shaft and an image sensor at a distal end of the elongated shaft; a handle coupled to the housing of the elongated shaft; a first accelerometer and gyroscope located within the housing and coupled to the elongated shaft such that rotation of the elongated shaft rotates the first accelerometer, wherein the first accelerometer and gyroscope are configured to provide a signal to determine rotation of the image sensor relative to a longitudinal axis of the elongated shaft, wherein the signal enables rotation of an image on the image display.
[0028] A variation of the endoscope may include a second accelerometer located within the handle wherein the image sensor in the insertion profile has a viewing angle of 0 to 15 degrees relative to a central axis of the insertion profile.
[0029] The endoscope described herein may further include a flexible circuit having a plurality of electrical conductors configured to transmit power and image signals to and from the image sensor, the flexible circuit including an outer dielectric layer configured to shield the plurality of electrical conductors from electrical interference.
[0030] Another variation of an endoscope includes an elongated shaft extending about a central axis to a distal end, carrying an image sensor at the distal end of the elongated shaft; a distal segment adjacent the distal end of the elongated shaft, wherein the distal segment includes an elongated discontinuity that allows side portions of the elongated shaft at the distal segment to flex outward as the elongated tool shaft advances through the working channel; a working channel located within the elongated shaft and extending to the distal segment of the elongated shaft; and a support sleeve located around a portion of the distal segment, the support sleeve pushing the side portions of the elongated shaft inward when the elongated tool shaft is removed.
[0031] The support sleeve may also include an elongated discontinuity extending along the length of the support sleeve.
[0032] One variation of the endoscope includes a flexible hinge located at the mid-section adjacent the distal section, wherein insertion of the elongated tool shaft causes the distal end of the elongated shaft to radially displace away from the central axis.
[0033] Another variation of the endoscope further includes a housing configured to carry the image sensor and the at least one light emitting diode.
[0034] The endoscope may further include an upper guide surface coupled to the housing, wherein distal advancement of the elongated tool shaft beyond the working channel causes the elongated tool shaft to push against the upper guide surface to deflect the housing. Optionally, the endoscope may further include a lower guide surface coupled to the sleeve of the working channel, wherein the lower guide surface provides a sliding interface against which the elongated tool shaft can be advanced through the distal section without contacting the support sleeve. BRIEF DESCRIPTION OF THE DRAWINGS
[0036] Additional aspects of the present invention will become apparent from the following description of illustrative embodiments and the accompanying drawings, in which:
[0037] Figure 1 Components of a hysteroscopic treatment system corresponding to the present invention are shown, including a perspective view of an endoscopic viewing system and a schematic diagram of a fluid management system.
[0038] Figure 2 yes Figure 1 A perspective view of an endoscopic viewing system showing a single-use, disposable endoscope component separated from a reusable handle component.
[0039] Figure 3A yes Figure 2A perspective view of a single-use endoscope component with the handle housing partially removed to show the interior portion of the component.
[0040] Figure 3B yes Figure 3A A perspective view of the endoscope components with the flow channel housing removed to illustrate features of the rotating shaft assembly.
[0041] Figure 4 yes Figure 1 Perspective views of the endoscopic viewing system from different angles, illustrating the rotation of the rotary axis assembly.
[0042] Figure 5 yes Figure 3A-3B Another perspective cross-sectional view of the endoscope components with the flow channel housing removed to illustrate the central axis of the working channel and the eccentric longitudinal axis of the outer sleeve of the endoscope shaft, about which the shaft assembly rotates.
[0043] Figure 6 yes Figure 1 and Figure 2 An enlarged perspective view of an endoscopic viewing system showing the finger-actuated control panel within the reusable handle assembly and the sterile and non-sterile areas of the components.
[0044] Figure 7A is an enlarged perspective view of the distal end of an endoscope shaft showing a working channel having a distal channel portion in a reduced cross-sectional configuration for introduction into a patient's body.
[0045] Figure 7B yes Figure 7A Another view of the distal end of an endoscope shaft showing the distal working channel portion in an expanded cross-sectional configuration as a tool is introduced through the working channel.
[0046] Figure 8 yes Figure 7A-7B Another view of the distal end of the endoscope shaft assembly showing the image sensor housing extending distally from the distal surface of the outer sleeve tip.
[0047] Figure 9 is another view of an endoscope handle assembly carrying at least one accelerometer for image orientation.
[0048] Figure 10 is a de-constructed view of the working end of an endoscope showing the flexible circuit configuration.
[0049] Figure 11 yes Figure 10 Another view of the working end of the endoscope.
[0050] Figure 12A is in a non-articulated configuration Figure 11 Another view of the working end of the endoscope.
[0051] Figure 12B is in an articulated configuration Figure 11 Another view of the working end of the endoscope.
[0052] Figure 13 yes Figure 11 、 Figure 12A and Figure 12B Exploded view of the components of the working end of an endoscope.
[0053] Detailed Description of the Invention
[0054] Figure 1 A hysteroscopic treatment system 50 according to the present invention is shown, which includes multiple components, including an endoscopic viewing system 50 and a fluid management system 105 housed in a base unit or console 108. The base unit 108 also carries a controller 110A and a power supply for operating the system 50, and may include an image processor 110B for processing signals from an image sensor carried by the endoscopic viewing system. A display 112 may be coupled to the base unit 108 for viewing images provided by the endoscopic viewing system 50.
[0055] More specifically, Figure 1 and Figure 2 The endoscopic viewing system 50 includes a reusable handle component 120 having a finger-actuated control pad 122 and a disposable, single-use endoscope component 125 having an elongated endoscope shaft 126 that carries a distal electronic imaging sensor 128 (see FIG. Figure 1 and Figure 7A The fluid management system 105 includes a first peristaltic inflow pump 140A and a second peristaltic outflow pump 140B, a fluid source 142, and a fluid collection reservoir 144. The fluid collection reservoir 144 may include a fluid deficit measurement subsystem as is known in the art. Each system and subsystem will be described in more detail below.
[0056] refer to Figure 1 、 Figure 2 and Figure 3B , it can be seen that the endoscopic viewing system 50 includes a handle component 120 and a detachable single-use endoscope component 125. Figure 2 In FIG. 1 , the single-use endoscope component 125 can be viewed as a component of a proximal handle housing 145 that carries a rotating shaft assembly 150 that is configured to rotate the handle housing 145 .
[0057] refer to Figure 1 、 Figure 3B and Figure 5 , the rotating shaft assembly 150 includes a proximal cylindrical grip 152 that is coupled to a molded rotating core 155 that is in turn coupled to an elongated outer sleeve 160 that extends to a distal working end 162 ( Figure 1 ). The rotating shaft assembly 150 rotates about the rotation axis 165. The working channel 170 extends from the proximal port 172 through the rotating shaft assembly 150 about the axis 165 (see Figure 2 and Figure 6 ). The working channel sleeve 174 carrying the working channel 170 can be Figure 3A 、 Figure 3B and Figure 5 Thus, the shaft assembly 150 rotates about the central longitudinal axis 165 of the working channel 170. Figure 5 and Figure 7A As can be seen, outer sleeve 160 has a central longitudinal axis 175 that is offset from longitudinal axis 165 about which shaft assembly 150 rotates. Figure 4 The grip 152 is shown with a visual marker 178 that aligns with the offset distal tip section 185 to allow an operator to know the orientation of the image sensor 128 by viewing the grip 152 .
[0058] exist Figure 1 、 Figure 4 、 Figure 6 and Figure 7A , the endoscope shaft 126 and more specifically the outer sleeve 160 can be seen extending with a straight proximal sleeve portion 180 to an offset distal tip section 185, wherein the axis 182 is also offset from the central axis 175 of the outer sleeve 160 by 2 mm to 10 mm ( Figure 7A The outer sleeve 160 has a transition section 186 that extends between the straight proximal sleeve section 180 and the offset distal tip section 185 at an angle ranging between 10° and 45° over a length of 5 mm to 20 mm. The imaging sensor 128 is disposed at the distal end of the offset tip section 185 (see FIG. Figure 7A ).like Figure 5 and Figure 7BAs can be seen, the endoscope component 125, and more specifically the working channel 170, is adapted to receive an elongated tool 188 that can be introduced through the working channel 170. In one variation, the elongated outer sleeve 160 has a diameter in each of the straight section, transition section, and distal tip section (180, 186, and 185, respectively) ranging between 4 mm and 10 mm, with the total length configured for hysteroscopy. More commonly, the diameter of the endoscope shaft 126 is from 5 mm to 6 mm in diameter. It has been found that the endoscope shaft 126 having the angled transition section 186 and the offset distal tip section 185 can be introduced through a patient's cervical canal without the cervical canal being dilated beyond the profile or diameter SD of the straight proximal sleeve section 180. In other words, as the endoscope shaft 126 is advanced through the cervical canal, the tissue surrounding the patient's cervical canal conforms to the angle in the endoscope shaft 126.
[0059] In one variation, the handle housing 145 of the endoscope component 125 is adapted to be removably slidably engaged with the handle component 120, as may be seen in FIG. Figure 2 and Figure 4 As will be readily appreciated, when assembled, an operator can grasp the pistol grip handle assembly 120 with one hand and rotate the cylindrical rotation grip 152 with the fingers of the other hand to rotate the endoscope shaft and image sensor 128, thereby orienting the viewing angle of the image sensor 128 and tool 188 to any desired rotational angle. As will be described below, the rotational shaft assembly 150 can rotate at least 180°, and more typically at least 270° ( Figure 3B and Figure 5 In one variation, shaft assembly 150 may be rotated 360° to orient image sensor 128 in any upward, lateral, or downward orientation relative to handle housing 145 .
[0060] like Figure 2 As can be seen in FIG, the handle housing 145 carries a protruding electrical connector 190A that is adapted to couple to a mating electrical connector 190B in the handle member 120. Although Figure 2The endoscope component 125 is shown as being configured for axial sliding engagement with the handle component 120, but it will be understood that the angled pistol grip portion 192 of the handle component 120 may be inserted into the endoscope component 125 in a different arrangement, such as a male and female plug connector or a threaded connector aligned with the axis 194 of the angled grip portion 192. As described below, the endoscope component 125 comprises a sterile device for use in a sterile field, while the handle component 120 may not be sterilized and is generally suitable for use in a non-sterile field. A cable 195 extends from the handle component 120 to the base unit 108, the imaging processor 110B, and the controller 110A including a power supply (see Figure 1 ).
[0061] like Figure 1 and Figure 2 As can be seen in FIG, the endoscope component 125 includes a fluid inflow tube 200A and a fluid outflow tube 200B that communicate with the fluid management system 105. Figure 1 As shown schematically in Figure 2 、 Figure 3A and Figure 3B As will be appreciated, the endoscope handle housing 145 may be comprised of two injection molded plastic housing elements 204a and 204b (see Figure 4 ), and Figure 3A One housing element 204a is shown removed to illustrate the interior of the handle housing 145. As can be seen, both the inlet and outlet tubes 200A, 200B are coupled to an injection molded flow passage housing 205 having an internal bore 208 configured to receive the rotating core 155 of the rotating shaft assembly 150.
[0062] Figure 3B is similar to Figure 3A Another view in which the second housing element 204b is removed and the flow channel housing 205 is also removed (dashed line view) to show how the stationary inlet pipe 200A and outlet pipe 200B are connected to the inlet path and the outflow path in the rotating shaft assembly 150 rotated at least 180°.
[0063] refer to Figure 3A and Figure 3B As can be seen, the rotating core 155 is centrally aligned with the axis 165 of the working channel 170 and is further coupled to the eccentric elongated outer sleeve 160 of the endoscope shaft 126. The proximal end 212 of the rotating core 155 is fixed to the handle 152 for rotating the rotating core 155 in the flow channel housing 205.
[0064] The rotating core 155 includes a first flange 218a, a second flange 218b, and a third flange 218c, which define annular flow passages 220 and 222 therebetween. As can be seen, the annular passage 220 is disposed between the first flange 218a and the second flange 218b. The annular passage 222 is disposed between the second flange 218b and the third flange 218c. Each of the first flange 218a, the second flange 218b, and the third flange 218c carries an outer O-ring 224a, 224b, and 224c. Figure 3A and Figure 3B , it can be understood how the rotating flanges 218a - 218c rotate within the bore 208 of the flow passage housing 205 and how the O-rings 224a - 224c maintain a fluid seal between the annular flow passages 220 and 222.
[0065] Reference again Figure 3A and Figure 3B , it can be seen that the distal end 230a of the inflow tube 200A is fixed in the flow passage housing 205 to communicate with the annular flow passage 222. Similarly, the distal end 230b of the outflow tube 200B is fixed in the flow passage housing 205 to communicate with the annular flow passage 220. Thus, each of the annular flow passages 222 and 220 can be rotated up to 360 degrees and communicate with the stationary distal ends of the inflow tube 200A and the outflow tube 200B.
[0066] Figure 3B Also shown is how the annular flow passages 222 and 220 communicate with a separate flow path that extends through the interior of the elongated sleeve 160 to the working end 162 of the endoscope shaft 126. The fluid inflow path may be in Figure 3B As can be seen in FIG, it extends through the annular gap AG outside the inner sleeve portion 235 surrounding the rotating core 155 in the second annular channel 222. This annular gap AG extends distally to communicate with the inner bore 242 of the outer sleeve 160. In a variant, as Figure 7A-7B As shown, the path within the inner bore 242 transitions to an inflow sleeve 244 having a distal outlet 245 .
[0067] The fluid outflow path can also be Figure 3B , where an opening 250 is provided in the inner surface of the annular space 220 of the rotating core 155, which communicates with the internal working channel 170. Thus, in one variation, the outflow path from the working space includes the working channel 170, which is fully open for fluid outflow when there is no tool 188 in the working channel. Figure 5, it can be seen that a tool seal 252 is shown in the proximal region of the working channel 170, which seals the channel 170 and also allows a tool 188 to be introduced therethrough. Many types of seals are known in the art, such as silicone sleeve seals, flap seals, etc. Typically, when a tool is introduced through the working channel 170, the tool itself will provide an outflow passage. Therefore, using the working channel 170 as an outflow passage is suitable for diagnostic procedures when an endoscope is used without a tool in the working channel.
[0068] In one method of use, the endoscope shaft 126 can be introduced through the distal end of the patient's cervical canal, wherein the inflow pump 140A and the outflow pump 140B (see FIG. Figure 1 ) operates to provide continuous irrigation through the distal tip section 185 of the endoscope component 125 while endoscopically viewing with the aid of the image sensor 128. Such a variation would thus allow fluid to flow in through the annular channel 222 and allow fluid to flow out through the working channel 170 and the annular channel 220.
[0069] Now go to Figure 7A-7B , the endoscope shaft 126 has a small insertion profile or configuration that includes an outer diameter of an elongated outer sleeve 160 that includes a proximal straight section 180, an angled transition section 186, and a distal tip section 185 ( Figure 7A ).exist Figure 7A As can be seen in FIG, the distal tip section 185 carries the image sensor 128 and two LEDs 260, which need to be electrically connected to the base unit 108, the controller 110A, and the imaging processor 110B. To provide the large number of electrical leads required by the image sensor 128, it was found that conventional multi-wire cables were too large to be accommodated by the small diameter outer sleeve 160, which also accommodates the working channel 170, the inflow channel 244, and potentially other fluid flow channels. For this purpose, it was found that the flat ribbon 265 ( Figure 5 ) in the form of a printed flexible circuit that can provide 10 to 40 electrical leads and occupy only a thin planar space within the endoscope shaft 126. Figure 7A A flexible circuit strip 265 is shown extending proximally from the image sensor 128 within the outer sleeve 160. Figure 3A 、 Figure 3B 、 Figure 5 and Figure 7A In one variation shown, a second flexible circuit strip 270 is provided to power the LEDs 260. In another variation, a first flexible circuit strip 265 can potentially carry electrical leads to the image sensor 128 and the two LEDs 260.
[0070] Now go to Figure 3A 、 Figure 3B and Figure 5 , shows a mechanism for providing the desired slack in the circuits or flexible circuit strips 265 and 270 to accommodate rotation of the rotary shaft assembly 150 relative to the handle housing 145 ( Figure 3A ).from Figure 3B and Figure 5 As best seen in FIG, the rotating shaft assembly 150 includes a first or distal spool 280 around which the flexible circuit ribbon 265 can be coiled or wound. The distal spool 280 forms part of the rotating core 155 of the rotating shaft assembly 150. The flexible circuit ribbon 265 can be provided in any suitable length as desired to allow the rotating shaft assembly 150 to rotate at least 180°, or more often, 360°, relative to the handle housing 145. Figure 3B and Figure 5 In the variation shown, it can be seen that the second or proximal spool 285 comprises a portion of the rotating core 155 and is adapted to receive a slack length of the second flexible circuit ribbon 270 extending to the two LEDs 260. Figure 3B and Figure 5 , it can be seen that the proximal ends 265', 270' of the flexible circuit strips 265, 270 are coupled to the electrical connector 190A via the plug connectors 288a and 288b. Figure 3A-3B The variation shows an endoscope handle in which the flexible circuit ribbon 265 is housed in a reel 280, but it should be understood that the slack portion of the flexible circuit ribbon can be configured to have at least one of a coiled form, a spiral form, or a folded form without a reel.
[0071] In one aspect of the present invention, reference Figure 7A, an endoscope shaft 126 carrying a distal image sensor 128 is provided, wherein the diameter of a working channel 170 in the shaft 126 is greater than 50% of the outer diameter of the shaft 126, and the electrical leads to the image sensor 128 comprise a flexible circuit 265. In this variation, the flexible circuit ribbon has a thickness of less than 0.4 mm and a width of less than 5.0 mm. More commonly, the flexible circuit ribbon has a thickness of less than 0.3 mm and a width of less than 4.0 mm. Furthermore, in this variation, the flexible circuit ribbon carries at least 10 electrical leads, and often more than 15 electrical leads. In another aspect, the electrical leads extending to the image sensor 128 are cables or ribbons having a cross-section less than 5% of the cross-section of the endoscope shaft 126. In another aspect of the present invention, an endoscope comprises a shaft carrying a distal image sensor, a working channel extending through the shaft, wherein the working channel in the distal shaft portion is reconfigurable between a collapsed shape and a non-collapsed shape to accommodate a tool introduced therethrough, wherein a combination of a diagonal dimension DD of the sensor and a diameter WCD of the working channel 170 is greater than a shaft diameter SD when in its insertion configuration or profile (see Figure 4 、 Figure 6 and Figure 7A ).
[0072] In a specific example, the image sensor 128 is available from OmniVision, 4275 Burton Drive, Santa Clara, CA, under the part name / number 95054: High Definition Sensor OV9734, 1280x720 Pixel Count. The sensor 128 has a package size of 2532 μm x 1722 μm, with a diagonal DD of 3062 μm or 3 mm. In addition, the proximal shaft (outer) diameter SD is 5 mm, with a working channel diameter WCD of 3 mm. Therefore, the combination of the sensor diagonal DD (3 mm) and the working channel diameter WCD (3 mm) equals 6 mm, which is greater than the 5 mm outer diameter of the shaft. In this example, the flexible circuit tape has a width of 3.4 mm and a thickness of 0.2 mm, with a cross-sectional area of 0.68 mm 2 , the cross-sectional area is 19.63mm 2 3.52% of a 5 mm diameter shaft. In this particular variation, the flexible circuit tape 265 carries 19 electrical leads.
[0073] Reference again Figure 7A-7B The distal portion of the endoscope shaft 126 includes a distal working channel portion 170', which can be formed in a first smaller cross-section (eg, Figure 7A As shown, for accommodating fluid outflow) and a second larger cross section (as Figure 7BAs shown, the tool 188 is adapted to be introduced through the working channel 170 and its distal portion 170'.
[0074] exist Figure 3A-3B 、 Figure 5 、 Figure 6 and Figure 7A In one variation shown in FIG, it can be seen that the working channel sleeve 174 defining the working channel 170 extends in a straight configuration from its proximal open port 172 through the endoscope component 125 to its open distal terminal end 290. Figure 7A and Figure 7B , the distal end 292 of the sleeve 174 has a straight and rigid upper surface 294. The working channel sleeve 174 has a flexible lower sleeve portion 296 or lower sleeve portion 296, and in one variation, the working channel sleeve 174 has a living hinge portion 298 below the sidewall cutouts 302a and 302b in the sleeve 174. In addition, the distal end of the endoscope shaft 126 includes an elastomeric sleeve 310 that surrounds the angled transition sleeve section 186, the distal tip section 185, and a distal portion 312 of the proximal straight sleeve section 180. Thus, as Figure 7A As can be seen in FIG, the elastomeric sleeve 310 has sufficient elastic strength to collapse or shrink the working channel portion 170' to a smaller cross-section, such as Figure 7A It can be seen in.
[0075] like Figure 7A As can be seen in FIG, lower sleeve portion 296 includes sleeve wall 315 having sufficient curvature to maintain an open path through distal working channel portion 170' when elastomeric sleeve 310 contracts distal channel portion 170', thereby always providing an open fluid outflow path. For example, sleeve wall 315 may have a curvature representing the same diameter as the proximal portion of sleeve 174 and extending over a radial angle ranging from 30° to 90°. Although Figure 7A The lower sleeve portion 296 shown in FIG. 1 comprises a portion of the wall of the metal sleeve 174 , but in another variation, the flexible lower sleeve portion 296 may be any bendable plastic material or a combination of plastic and metal.
[0076] Figure 7BNext, the distal working channel portion 170' is shown in its second, expanded configuration as the physician inserts the elongated tool 188 (see dashed line view) through the working channel 170. Such a tool 188 will first slide along the hinge portion 298 of the lower sleeve portion 296, and then stretch the elastomeric sleeve 310 to open the distal working channel portion 170' to allow the tool 188 to extend through the working channel. In other words, when the tool is inserted through the distal working channel portion 170', the elastomeric sleeve 310 will be stretched or deformed to the point where the tool is inserted through the distal working channel portion 170'. Figure 7B When the tool 188 is withdrawn from the working channel portion 170', the elastomeric sleeve 310 will be Figure 7B The tensioning position returns to Figure 7A rest or untensioned position to return the working channel portion 170' to Figure 7A contracted configuration.
[0077] In general, an endoscope assembly 125 according to the present invention allows for the use of an image sensor 128 having a large diagonal dimension relative to the insertion profile or diameter of the endoscope shaft 126, while simultaneously providing a working channel 170 having a large working channel diameter WCD relative to the insertion profile or diameter of the endoscope shaft assembly 126. More specifically, the endoscope assembly 125 includes an endoscope shaft 126 having a shaft diameter SD extending to a distal sleeve section 185, an image sensor 128 having a diagonal dimension DD carried by the distal sleeve section 185, and a working channel 170 having a diameter WCD extending through the elongated shaft 126, wherein a working channel portion 170′ in the distal end of the shaft 126 is adjustable in shape to accommodate a tool 188 introduced therethrough, and wherein the combination of the sensor's diagonal dimension DD and the working channel diameter WCD is greater than the shaft diameter SD (see FIG. 2 ). Figure 7A ).
[0078] In variations, the sensor's diagonal dimension DD is greater than 50% of the shaft diameter SD or greater than 60% of the shaft diameter. In variations, the working channel diameter WCD is greater than 30% of the shaft diameter, greater than 40% of the shaft diameter, or greater than 50% of the shaft diameter. In other words, the working channel portion 170' in the distal end is adjustable between a first cross-sectional size and a second cross-sectional size. Figure 7A-7B In a variation of this embodiment, a working channel portion 170' in the distal region of the endoscope shaft 126 is adjustable between a partially collapsed shape and a non-collapsed shape.
[0079] In one variation, reference Figure 7A , the distal tip section 185 of the endoscope shaft 126 has an axial dimension D1 ranging from 5 mm to 20 mm. Figure 7A, the angled transition sleeve section 186 extends over a similar axial dimension D2 ranging from 5 mm to 20 mm. Still referring to Figure 7A The central axis 182 of the distal tip segment 185 may be parallel to and offset from the longitudinal axis 175 of the straight shaft segment 180 by a distance ranging from 1 mm to 10 mm.
[0080] Now turn Figure 8 , the image sensor 128 is carried in a sensor housing 340, which also carries a lens assembly 345 as is known in the art. In one variation, the housing 340 also carries one or more light emitters, Figure 7A and Figure 7B In the variation shown, two LEDs, indicated at 260, are shown carried in opposite sides of the sensor housing 340. Of particular interest are the Figure 8 , the distal-most surface 350 of the lens assembly 345 and the LED 260 are disposed distally outward from the distal surface 352 of the distal tip segment 185. It has been discovered that such positioning of the distal-most surface 350 of the lens assembly and the LED outward from the distal surface 352 of the distal tip segment 185 can improve illumination from the LED 260 and improve the field of view of the image sensor 128. Figure 8 The distance indicated by D3 may be in the range from 0.2 mm to 2.0 mm.
[0081] Now refer to Figure 7A Another aspect of the present invention includes an optional dedicated fluid pressure sensing channel 360 that extends through a thin-walled sleeve (not shown) in the endoscope shaft 126. Figure 7A As can be seen in FIG, the distal end of the pressure sensing channel 360 is open in the distal surface 352 of the endoscope shaft 126. The pressure sensing channel 360 can extend to a disposable pressure sensor (not shown) in the handle housing 145. Such a disposable pressure sensor can then have electrical leads connected through the electrical connector 190A in the handle housing 145 to the controller 110A ( Figure 1 ) sends an electrical signal indicative of pressure. Thus, in one aspect, the disposable endoscope component 125 carries a single-use pressure sensor that is coupled to the remote controller 110A via a detachable connector.
[0082] refer to Figure 7AIn one variation of the pressure sensing mechanism, the walls of the pressure sensing channel 360 are composed of a hydrophobic material, which can be any suitable polymer, such as PFTE, with an inner diameter ranging from 0.25 mm to 2.5 mm. Typically, the diameter of the channel 360 is between 0.5 mm and 1.5 mm. It has been found that the hydrophobic surface in the pressure sensing channel 360 will prevent fluid from migrating into the channel, thereby trapping an air column in the channel communicating with the pressure sensor. The compressibility of the air column in the pressure sensing channel 360 does not significantly affect the sensed pressure because the channel diameter is very small. In another variation, the metal sleeve can be coated with a hydrophobic surface or a super hydrophobic surface.
[0083] Now refer to Figure 1 、 Figure 2 and Figure 4 , it can be seen that the handle member 120 has an angled pistol grip portion 192 having an axis 194 angled from 10° to 90° away from the axis 175 of the endoscope shaft 126. The grip portion 192 includes a finger-actuated or thumb-actuated control pad 122 that carries actuator buttons for operating all functions of the treatment system, including, for example, (i) operating the fluid management system 105, (ii) capturing images or video from the sensor 128, (iii) adjusting the light intensity from the LED 260, etc. As described above, the control unit 108 typically carries the image processor 110B. However, the interior of the handle member 120 may also carry the image processor 110B or processing components thereof.
[0084] Figure 4 The handle assembly 120 and the endoscope assembly 125 are shown from different angles, where it can be seen that the grip portion 192 has a recessed channel 385 therein adapted to receive and lock the inflow and outflow tubes 200A, 200B in place, thereby integrating the tube set with the pistol grip 192 during use. This feature is important so that the inflow and outflow tubes will not interfere with the operation of the endoscope assembly 125 or the operation of tools introduced through the working channel 170. The pistol grip 192 can have a single recessed channel 385 to receive both the inflow and outflow tubes, or two recessed channels to receive the inflow and outflow tubes separately.
[0085] Now go to Figure 6, an enlarged view of the assembled handle component 120 and endoscope component 125 shows a control panel 122 having four actuator buttons or switches adapted to operate the system. In one variation, actuator 402 is adapted to turn irrigation on and off, or in other words, to actuate the fluid management system 105 to provide fluid inflow and outflow. Actuator 404 is adapted to capture images or video. In one variation, momentary depression of actuator 404 will capture a single image, while more prolonged pressure on the actuator will produce a video record.
[0086] The actuator or scroll button 406 has a scrolling function, wherein pressing the scroll button 406 will cycle through the various subsystems, each of which can be further adjusted by the central button or up / down actuator 410, which is suitable for increasing, decreasing or otherwise changing the operating parameters of any selected subsystem. In one example, the scroll button 406 can be actuated to cycle through the following subsystems and features: (i) fluid inflow / outflow rate from the fluid management system 105; (ii) set pressure to be maintained by the fluid management system 105; (iii) fluid deficit alarm calculated by the fluid management system 105; (iv) optional selection of still image capture or video capture, and (v) light intensity of the LED. Then, after scrolling to select the subsystem, the physician can actuate the central up / down actuator 410 to adjust the operating parameters of the selected subsystem. As will be further described below, the selection of the subsystem and the real-time operating parameters of each subsystem will be displayed in the following manner: Figure 1 112. Thus, it will be appreciated that the physician can operate the scroll buttons 406 to scroll through and select any subsystem or feature while viewing the selection, such as on the display 112, and then actuate the up / down actuator 410 to adjust an operating parameter, which can also be viewed on the display 112.
[0087] In another aspect of the present invention, the controller 110A includes a control algorithm for operating the control panel 122 that provides for a return to a default state after the scroll button or actuator 406 has been used by the physician. For example, the default state may be a selected default subsystem that can be actuated by the central up / down actuator 410. In one variation, the default subsystem is the fluid inflow / outflow rate, which may be the most commonly used subsystem actuated by the physician to control the flow of fluid into and out of the workspace. As described above, the physician can use the scroll button 406 to select any subsystem for adjusting operating parameters. However, if the physician does not continue to scroll between subsystems or change parameters within a predetermined time interval, the control algorithm will return to the default subsystem, which may be the fluid inflow / outflow rate. The predetermined time interval or timeout period for the control algorithm to return to the default state can be anywhere from 1 second to 10 seconds, more commonly anywhere between 2 seconds and 5 seconds.
[0088] Still refer to Figure 6 , shows the assembly of the handle component 120 and the endoscope component 125, with plane P to illustrate the sterile field 415 and the non-sterile field 420 relative to the endoscope assembly. As can be appreciated, the disposable endoscope component 125 is sterilized, and the doctor or nurse will remove the component 125 from the sterile packaging, which will then define the sterile field 415. The endoscope component 125 will then mate with the handle component 120 defining the non-sterile field 420. In other variations (not shown), a plastic film or other plastic shell can cover the handle portion 120.
[0089] from Figure 6 It will be appreciated that the physician must insert the tool 188 into the working channel 170 in a manner that ensures the sterility of the tool. Figure 6 As can be seen in the figure, the sterile grip 152 has a large diameter recess R therein that tapers to form the proximal port 172 of the working channel 170. In one embodiment, the diameter of the recess R is at least 15 mm and is typically greater than 20 mm. The depth of the recess can range from 5 mm to 20 mm or more. Therefore, it can be appreciated that the doctor can easily insert the distal end 425 of the tool 188 into the opening of the large diameter recess R without any risk of contact with the non-sterile handle portion 120. Thereafter, the doctor can move the tool distal end 425 distally over the surface 428 of the recess R and into and through the port 172 of the working channel 170. By using this method, the doctor can ensure that the tool 188 will not contact the non-sterile area 420.
[0090] Now go to Figure 9, shows another aspect of the present invention, which relates to electronic mechanisms carried by endoscope 500 for reorienting the image on the display in response to rotation of the endoscope axis 510 to ultimately provide an image upright configuration on the display. In one variation, an accelerometer 515 (which may include an accelerometer-gyroscope combination) is provided, which can send signals related to the rotation of the endoscope axis 510 to the controller and image processor. For example, a 3-axis accelerometer such as the STmicroIIS2DH can be used, or a 6-axis IMU (Inertial Motion Unit) having a 3-axis accelerometer and a 3-axis gyroscope such as the STmicroISM330DLC can be used.
[0091] The image processor in the controller can then use the accelerometer signal to calculate the amount of rotational correction required to reorient the image. This calculation includes the degree of rotation of the shaft 510 relative to the longitudinal axis 518 of the shaft 510. The image is then electronically rotated for display on any video display or monitor, which can be carried by the device's handle or, most commonly, a remote display. As a result, the video image on the display can always be in an upright configuration for viewing by the physician.
[0092] from Figure 9 As can be seen in FIG, the accelerometer 515 is carried on the proximal spool 285 which is rotatable within the handle assembly 520. Thus, any rotation of the rotating member 522 relative to the longitudinal axis 518 of the shaft, independent of the handle 524 or rotation of the handle 524, will be sensed by the accelerometer 515, thereby allowing the image to be re-orientated on the display. Figure 9 In a variation of the present invention, a second accelerometer 540 is carried on a circuit board 545 that is fixed to the non-rotating handle 524. Thus, the signal from this accelerometer 540 only provides a signal of handle rotation. In one variation, the signals from the two accelerometers 515, 540 can be compared to determine the rotation of the rotating component relative to the handle 524. In one aspect, if the signal from the first accelerometer 515 fails for any reason, the signal from the second accelerometer 540 can be used. An alert on the display can indicate to the user if the first or second accelerometer is not functioning properly.
[0093] Figure 10 and Figure 11 Another variation of the endoscope working end 550 is shown, which is similar to the previous embodiment. Figure 10 554 and a thin-walled working channel sleeve 554 are shown. As previously described, the image sensor 555 ( Figure 11) and power for the image sensor and LEDs 558A and 558B are carried in a flexible circuit 560 that extends through the endoscope's shaft 510. Because the endoscope shaft 510 will be operating in a fluid environment, it has been found that significant RF shielding is required around the signal-carrying electrical conductors in the flexible circuit 560 to ensure that potential electrical devices introduced through the working channel 564 do not generate electric fields that could interfere with the signals carried in the flexible circuit 560.
[0094] Therefore, in Figure 10 In one variation shown, the flexible circuit can be an edge-bonded stripline design in which two outer dielectric layers 562a and 562b carry electrical conductors 565 (including a ground plane) and are configured to act as a shield relative to electrical conductors 570 disposed in a middle layer 572 between the two outer layers 562a and 562b. In this variation, the plurality of electrical conductors 570 disposed in the middle layer 572 are adapted to carry all signals from the image sensor 555. Thus, the two outer layers 562a and 562b act as a shield to prevent any potential interference from electrical tools that could interfere with the signals carried by the inner conductors 570 in the middle layer 572.
[0095] In one variation, the signal carrying conductors 570 in the middle layer 572 are provided on both sides with a dielectric insulation layer having a thickness of at least 0.0005", at least 0.001", or at least 0.002". The insulation layer can be any suitable electrical material, such as Kapton.
[0096] In some variations, the number of electrical conductors 570 in the intermediate layer 572 that carry image signals can vary from 4 to 24 or more, and is typically in the range of 12 to 20 conductors. In this variation, the electrical leads to the LEDs 558A and 558B are also carried in the intermediate layer 572, which may be subject to interference from electrical tools. Thus, in a stripline design, providing the electrical leads and signal conductors in the intermediate layer 572 allows the entire flexible circuit 560 to be thinner and more flexible than other configurations that provide adequate RF shielding.
[0097] Now go to Figure 11-13 , the endoscope shaft working end 550 is similar to Figure 7A and Figure 7B The working end of the shaft. Figure 11In a variation of the present invention, the shaft working end 550 has a second flexible hinge portion 580 that allows the field of view FOV of the image sensor 555 to be changed around its axis 574. For introduction into a working site within a patient's body, the working end 550 of the shaft 510 has a distal section 585 having an axis 574 that is inclined at a selected angle relative to the longitudinal axis 518 of the shaft 510, which can be from 5° to 30°. Figure 11 As can be seen in the figure, the second or intermediate section 595 of the working end 550 includes a living hinge portion 580 that allows it to bend relative to the proximal shaft section 600. The intermediate section 595 and the distal section 585 are fixed together at a certain angle, such as Figure 11 and Figure 12A Mechanism for actuating the distal segment 585 and the intermediate segment 595 to the bent position (see Figure 12B ) includes inserting an elongated tool body or shaft 604 through the working channel 564 as previously described.
[0098] Figure 12A and Figure 12B yes Figure 11 A schematic perspective view of the working end 550 of FIG. 5 shows the internal working channel 564 and the proximal shaft segment 600, the intermediate shaft segment 595 and the distal shaft segment 585. Figure 12B 564, which results in a number of effects. First, as previously described, the elongated tool shaft 604 stretches the resilient silicone sleeve 610 ( Figure 11 ) to expand the working channel 564 from the collapsed state to the expanded state. Simultaneously, the introduction of the tool shaft 604 through the working channel 564 causes the proximal hinge 580 at the proximal end of the intermediate section 595 to bend so that the intermediate section 595 and the distal section 585 move from the rest position ( Figure 12A ) bends to the tensioning position ( Figure 12B ), wherein the axis 574 of the image sensor 555 is parallel to the longitudinal axis 518 of the proximal shaft portion 600. Figure 12B In this bent position, the image sensor 555 is then aligned with the longitudinal axis 518 of the shaft and the sensor axis 574, and the angle of the field of view FOV can then be 0 relative to the longitudinal axis 518 of the shaft.
[0099] exist Figure 11 In the variation shown, it can be seen that a tensioning support sleeve 625 is shown that partially surrounds the proximal endoscope shaft portion 600 and the sleeve segment 595. More specifically, the support sleeve 625 has an upper surface 628 secured to an adjacent upper surface 630 of the proximal shaft portion 600. The support sleeve 625 has a longitudinal discontinuity 626 therein and extends from approximately 200° to 360° around the shaft. Figure 11 It can also be seen in FIG that the support sleeve of length LL extends over a portion of the proximal shaft 600 and over a portion of the intermediate sleeve 595. Figure 11 and Figure 13 As can be seen, the interior portion of the support sleeve 625 has a longitudinal gap or discontinuity 626 that allows the side portions 640a and 640b to flex outwardly when the elongated tool shaft 604 is introduced through the working channel 564. In this regard, the support sleeve 625 acts as a spring, urging the side portions 640a and 640b radially inwardly to return the endoscope shaft 510 to a straight configuration when the tool shaft 604 is removed from the working channel 564.
[0100] refer to Figure 13 8A and 8B, and the like. In another aspect of the invention, the distal end of the distal shaft segment 585 can be seen to include a housing 650 that carries the image sensor 555 and both the first LED 558A and the second LED 558B. The housing 650 can be molded from any suitable polymer and includes means for providing a flexible circuit connection to the image sensor 550 and the LEDs. An upper guide surface 655 is coupled to the sensor housing 650 to provide a sliding interface against which the tool shaft 604 can push and deflect the distal segment 585 and the sensor housing 650. A lower guide surface 660 is coupled to the working channel sleeve 554 via a flexible element 664 to provide a sliding interface against which the tool shaft 604 can open the working channel 564 without contacting the silicone sleeve 610 (see FIG. 2 ). Figure 11 ).
[0101] Although specific embodiments of the present invention have been described in detail above, it will be understood that this description is for illustrative purposes only and that the above description of the present invention is not exhaustive. Specific features of the present invention are shown in some drawings and not in other drawings, and this is merely for convenience, and any feature according to the present invention may be combined with another feature. Many variations and alternatives will be apparent to those skilled in the art. Such alternatives and variations are intended to be included within the scope of the claims. The specific features presented in the dependent claims may be combined and fall within the scope of the present invention. The present invention also encompasses embodiments in which the dependent claims are alternatively written in the format of multiple dependent claims with reference to other independent claims.
[0102] Other variations are within the spirit of the invention. Thus, while the invention is susceptible to various modifications and alternative constructions, certain illustrative embodiments thereof are shown in the drawings and have been described above in detail. However, it should be understood that there is no intention to limit the invention to the particular form or forms disclosed, but on the contrary, it is intended to cover all modifications, alternative constructions, and equivalents falling within the spirit and scope of the invention as defined in the appended claims.
[0103] The use of the terms "a," "an," "the," and similar references in the context of describing the present invention (especially in the context of the appended claims) are to be construed to include both the singular and the plural, unless otherwise indicated herein or clearly contradicted by the context. The terms "comprising," "having," "including," and "containing" are to be understood as open-ended terms (i.e., meaning "including, but not limited to,") unless otherwise noted. The term "connected" is to be understood as partially or completely contained within, attached to, or joined together, even if there are some intervening parts. The recitation of numerical ranges herein is merely intended to serve as a shorthand method of individually referring to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by the context. The use of any and all examples or exemplary language (e.g., "such as") provided herein is intended merely to better illustrate embodiments of the invention and does not constitute a limitation on the scope of the invention unless otherwise stated. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.
[0104] All references, including publications, patent applications, and patents, cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.
[0105] This application relates to but is not limited to the following embodiments:
[0106] Embodiment 1. A method for orienting an image from an endoscope having an image sensor on a display, comprising:
[0107] providing an endoscope having a longitudinal axis and a distal image sensor that provides an image on a display;
[0108] providing at least one of an accelerometer and a gyroscope carried by the endoscope;
[0109] acquiring a signal from at least one of an accelerometer and a gyroscope resulting from rotation of the endoscope relative to the longitudinal axis;
[0110] The image is rotated on the display in response to the signal to correct the orientation to a selected configuration.
[0111] Embodiment 2. The method of embodiment 1, wherein the selected configuration is an image-erect configuration.
[0112] Embodiment 3. The method of embodiment 1, wherein the rotating step comprises electronically manipulating the image.
[0113] Example 4. A method according to Example 1, wherein the accelerometer is located on a rotating component within the housing of the endoscope, the method further comprising rotating the distal image sensor independently of the handle of the endoscope, and using the accelerometer to determine the rotation of the distal image sensor independent of the handle.
[0114] Example 5. The method according to Example 1 further includes providing at least a second accelerometer, wherein the second accelerometer is carried on the handle of the endoscope, and the method further includes obtaining a signal from the second accelerometer and comparing the signal from at least one of the accelerometer and the second accelerometer.
[0115] Example 6. An endoscope electrically coupled to an image display, the endoscope comprising:
[0116] an elongated shaft having a housing at a proximal end of the elongated shaft and an image sensor at a distal end of the elongated shaft;
[0117] a handle coupled to the housing of the elongated shaft;
[0118] a first accelerometer and a gyroscope within the housing and coupled to the elongated shaft such that rotation of the elongated shaft rotates the first accelerometer,
[0119] Wherein the first accelerometer and the gyroscope are configured to provide signals to determine rotation of the image sensor relative to a longitudinal axis of the elongated shaft, wherein the signals enable rotation of an image on the image display.
[0120] Example 7. The endoscope of Example 6 further comprising a second accelerometer located within the handle, wherein the image sensor in the insertion profile has a viewing angle of 0 to 15 degrees relative to a central axis of the insertion profile.
[0121] Example 8. The endoscope according to Example 6 further includes a flexible circuit having a plurality of electrical conductors, wherein the plurality of electrical conductors are configured to transmit power and image signals with the image sensor, and the flexible circuit includes an external dielectric layer, wherein the external dielectric layer is configured to shield the plurality of electrical conductors from electrical interference.
[0122] Example 9. The endoscope of Example 6, wherein the elongated shaft further comprises a distal segment adjacent the distal end of the elongated shaft, wherein the distal segment comprises an elongated discontinuity that allows a side portion of the elongated shaft at the distal segment to flex outwardly;
[0123] a working channel located within the elongated shaft and extending to the distal segment of the elongated shaft, wherein advancing an elongated tool shaft out of the working channel causes the side portions of the elongated shaft to flex outwardly; and
[0124] A support sleeve is positioned around a portion of the distal segment, the support sleeve urging the side portion of the elongated tool shaft inwardly when the elongated tool shaft is removed.
[0125] Example 10. An endoscope according to Example 9, wherein the support sleeve includes an elongated discontinuity extending along the length of the support sleeve.
[0126] Example 11. The endoscope of Example 9 further comprising a flexible hinge located at a mid-section adjacent the distal section, wherein insertion of the elongated tool shaft causes the distal end of the elongated shaft to shift radially away from the central axis.
[0127] Example 12. The endoscope according to Example 9 further includes a housing configured to carry the image sensor and at least one light emitting diode.
[0128] Example 13. The endoscope of Example 12 further comprising an upper guide surface coupled to the housing, wherein distal advancement of the elongated tool shaft beyond the working channel causes the elongated tool shaft to push against the upper guide surface to deflect the housing.
[0129] Example 14. The endoscope according to Example 12 further includes a lower guide surface of a sleeve connected to the working channel, wherein the lower guide surface provides a sliding interface, and the elongated tool shaft can advance through the distal section against the sliding interface without contacting the support sleeve.
[0130] Example 15. An endoscope comprising:
[0131] an elongated shaft extending about a central axis to a distal end, carrying an image sensor at the distal end of the elongated shaft;
[0132] a distal segment adjacent the distal end of the elongated shaft, wherein the distal segment includes an elongated discontinuity that allows side portions of the elongated shaft at the distal segment to flex outwardly as the elongated tool shaft is advanced through the working channel;
[0133] a working channel located within the elongated shaft and extending to the distal segment of the elongated shaft; and
[0134] A support sleeve is positioned around a portion of the distal segment, the support sleeve urging the side portion of the elongated tool shaft inwardly when the elongated tool shaft is removed.
[0135] Example 16. An endoscope according to Example 15, wherein the support sleeve includes an elongated discontinuity extending along the length of the support sleeve.
[0136] Example 17. The endoscope of Example 15 further comprising a flexible hinge located at a mid-section adjacent to the distal section, wherein insertion of the elongated tool shaft causes the distal end of the elongated shaft to shift radially away from the central axis.
[0137] Example 18. The endoscope according to Example 15 further includes a housing constructed to carry the image sensor and at least one light emitting diode.
[0138] Example 19. The endoscope of Example 18 further comprising an upper guide surface coupled to the housing, wherein distal advancement of the elongated tool shaft beyond the working channel causes the elongated tool shaft to push against the upper guide surface to deflect the housing.
[0139] Example 20. The endoscope according to Example 18 further includes a lower guide surface of a sleeve connected to the working channel, wherein the lower guide surface provides a sliding interface, and the elongated tool shaft can advance through the distal section against the sliding interface without contacting the support sleeve.
Claims
1. An endoscope electrically coupled to an image display and configured for use with an elongated tool, the endoscope comprising: an elongated shaft having a shaft assembly at a proximal end of the elongated shaft, an image sensor, and a distally-facing lens at a distal end of the elongated shaft; a handle coupled to the shaft assembly, wherein the shaft assembly is rotatable within the handle; a working channel extending through the elongated shaft and having a proximal channel portion having a central axis and a first cross-section and a distal channel portion having a second, reduced cross-section in a first position; wherein the distal channel portion is expandable such that advancement of the elongated tool in the distal channel portion expands the distal channel portion about the central axis to a second position that permits ejection of a portion of the elongated tool from the distal channel portion, wherein the distal channel portion includes a first sidewall cutout and a second sidewall cutout; a first accelerometer coupled to the shaft assembly and to the elongated shaft such that rotation of the shaft assembly and the elongated shaft rotates the first accelerometer and the elongated shaft, wherein the first accelerometer is configured to provide a signal to determine rotation of the image sensor relative to a longitudinal axis of the elongated shaft, wherein the signal allows rotation of an image on the image display; and a support sleeve positioned around a portion of the distal channel portion, the support sleeve being configured to flex outwardly with the distal channel portion, wherein an interior portion of the support sleeve includes a longitudinal discontinuity, wherein the support sleeve urges the distal channel portion inwardly upon removal of the elongated tool; and A lower guide surface is coupled to the sleeve of the working channel and is configured to provide a sliding interface against which the elongated tool can be advanced through the distal end without contacting the support sleeve.
2. The endoscope of claim 1 , further comprising a second accelerometer located within the handle, wherein the elongated shaft comprises an insertion profile, and the image sensor in the insertion profile has a viewing angle of 0 to 15 degrees relative to a central axis of the insertion profile.
3. The endoscope according to claim 1 further includes a flexible circuit having a plurality of electrical conductors, wherein the plurality of electrical conductors are configured to transmit power and image signals to the image sensor, and the flexible circuit includes an outer dielectric layer, wherein the outer dielectric layer is configured to shield the plurality of electrical conductors from electrical interference.
4. The endoscope according to claim 1, wherein The distal channel portion includes an elongated discontinuity that allows side portions of the distal channel portion to flex outwardly.
5. The endoscope according to claim 4, wherein: The discontinuity of the support sleeve extends along the length of the support sleeve.
6. The endoscope of claim 4, further comprising a flexible hinge located at a mid-section adjacent the distal end, wherein insertion of the elongated shaft causes the distal end of the elongated shaft to radially displace away from the central axis.
7. The endoscope of claim 4, further comprising a housing configured to carry the image sensor and at least one light emitting diode.
8. The endoscope of claim 7, further comprising an upper guide surface coupled to the housing, wherein distal advancement of the elongated shaft beyond the working channel causes the elongated shaft to push against the upper guide surface to deflect the housing.
9. An endoscope comprising: an elongated shaft extending about a central axis to a distal end, carrying an image sensor at the distal end of the elongated shaft; a distal segment adjacent the distal end of the elongated shaft, wherein the distal segment includes an elongated discontinuity; a working channel within the elongated shaft and having a distal channel portion extending through the distal segment of the elongated shaft, wherein the distal channel portion comprises a first cross-sectional area that is smaller than a cross-sectional area of the working channel, wherein the distal channel portion comprises a first sidewall cutout and a second sidewall cutout; wherein the elongated discontinuity allows a side portion of the elongated shaft at the distal section to flex outwardly as the elongated tool shaft is advanced through the working channel; wherein passage of the elongated tool shaft through the distal channel portion causes the side portions of the elongated shaft to bend outwardly to increase the first cross-sectional area, thereby allowing a portion of the elongated shaft to be pushed out of the distal channel portion; a support sleeve positioned around a portion of the distal segment, wherein an interior portion of the support sleeve includes a longitudinal discontinuity that urges the side portions of the elongated tool shaft inwardly upon removal of the elongated tool shaft; and A lower guide surface is coupled to the sleeve of the working channel and is configured to provide a sliding interface against which the elongated tool shaft can be advanced through the distal end without contacting the support sleeve.
10. The endoscope according to claim 9, wherein: The discontinuity of the support sleeve extends along the length of the support sleeve.
11. The endoscope of claim 9, further comprising a flexible hinge located at a mid-section adjacent the distal section, wherein insertion of the elongated tool shaft causes the distal end of the elongated shaft to radially displace away from the central axis.
12. The endoscope of claim 9, further comprising a housing configured to carry the image sensor and at least one light emitting diode.
13. The endoscope of claim 12, further comprising an upper guide surface coupled to the housing, wherein distal advancement of the elongated tool shaft beyond the working channel causes the elongated tool shaft to push against the upper guide surface to deflect the housing.
Citation Information
Patent Citations
Endoscope with multiple image sensors
US20180084971A1
Endoscope system and method of use
US20180326144A1
Video Endoscope
US20080214892A1
Fully integrated, disposable tissue visualization device
US20150196197A1
Device for use in hysteroscopy
US20170319047A1