Endoscope and how to use it

Abstract

The endoscope includes a shaft having a proximal end and a distal end and a longitudinal axis therebetween. A handle is coupled to the proximal end of the shaft, and an image sensor is carried on the distal end of the shaft. A channel extends through at least a distal shaft portion and has a channel diameter, and a portion of the channel is reconfigurable between a contracted shape and a non-contracted shape to accommodate a tool introduced therethrough. The combined diagonal dimension and channel diameter are typically greater than the shaft outer diameter. The image sensor can be connected to a connector on a housing via a first loose flexible circuit, and a light source on the shaft can be connected to a connector on the housing via a second loose flexible circuit.

Description

[0001] Cross-references

[0002] This application claims the benefit of U.S. Application No. 16 / 022,521, filed June 28, 2018, which is incorporated herein by reference. Background Art

[0003] 1. Field of the Invention 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.

[0004] The endoscopic system of the present invention for hysterectomy generally includes a base having an image display, a disposable endoscope component having an image sensor, a reusable handle component connected to an image processor in the base, and a fluid management system integrated with the base and handle components. The endoscope component and the reusable handle are generally referred to as a hysteroscope.

[0005] The present invention is particularly concerned with hysteroscopes and other endoscopes that provide for the introduction of interventional tools through a working channel in the shaft of the barrel. The size of a hysteroscope's working channel is limited by the need to introduce at least a distal portion of the shaft through the patient's cervix.

[0006] It is further contemplated by the present invention that the hysteroscope may have a shaft that is rotatable relative to the handle and that typically carries a camera and light source that need to be connected externally through the handle.

[0007] It is still further contemplated by the present invention that the rotatable hysteroscopic shaft may also carry fluid through an inner lumen having an external port fixed in the handle.

[0008] For these reasons, it is desirable to provide an improved hysteroscope that can accommodate the introduction of relatively large tools through a shaft having a relatively small profile. It is further desirable to provide an improved hysteroscope that can accommodate a camera, a light source, etc. connected to a rotatable shaft through a fixed handle. It is still further desirable to provide an improved hysteroscope that can accommodate fluid flow through a rotatable shaft coupled to a fixed handle. At least some of these objects will be achieved by the invention described below.

[0009] 2. Description of Background Technology Hysteroscopic systems similar to those shown herein are described in the following 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

[0010] In a first aspect of the invention, a hysteroscope or other endoscopic system includes a shaft having a shaft outer diameter, a distal shaft portion, a proximal shaft portion, and a longitudinal axis therebetween. A handle is coupled to the proximal portion of the shaft, and an image sensor having a diagonal dimension is carried on the distal portion of the shaft. A channel extends at least through the distal shaft portion and has a channel diameter. A portion of the channel in the distal portion of the shaft can be reconfigured 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 combined diagonal dimension and channel diameter can be greater than the shaft outer diameter. The handle will typically be detachably coupled to the shaft so that the handle is reusable and the shaft is disposable, but at least some aspects of the invention will also be found in endoscopes that include a fixed handle-shaft structure.

[0011] 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, usually 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, more often at least 60% of the outer diameter of the shaft, or more.

[0012] In other exemplary embodiments, the endoscope of the present invention will be provided in a system further comprising a fluid inflow source for providing fluid flow through an inflow channel in the shaft to an outlet in the distal portion of the shaft. Typically, such a system will further include a negative pressure source for providing fluid outflow through an outflow channel in the shaft and an opening in the distal shaft portion. Further, the system may include a controller for controlling fluid flow through the inflow channel and the outflow channel, and at least one actuator in a handle for regulating fluid inflow and outflow. For example, the controller may be configured with an algorithm for operating a fluid inflow source and a negative pressure source to maintain the fluid within a set pressure range within a working space such as a uterine cavity.

[0013] 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 about a longitudinal axis relative to the handle through an arc of approximately 180° or greater, typically reversibly. An electronic image sensor is carried at the distal end of the shaft, and one or more electrical leads extend from the image sensor to an electrical connector in the handle. One or more electrical conductors are flexible and are configured with "slack" within the interior of the handle to accommodate rotation of the shaft. "Slack" means that the length of the electrical lead is greater than the distance between the electrical connector and the point of attachment of the electrical lead to the shaft, so that the shaft can be rotated without over-tightening the electrical lead.

[0014] In other exemplary embodiments of the endoscope, the slack portion can be formed as any one of a coil, a spiral, a folded structure, a serpentine structure, etc. In a specific embodiment, one end of the slack portion will be coupled to the axis of the rotating shaft assembly and extend around the axis of the rotating shaft assembly, and one end of the slack portion is usually carried on a reel fixed to the shaft assembly. The reel is usually concentric or coaxially aligned with the axis of the shaft so that as the shaft rotates, the reel can accommodate or release the flexible electrical lead as needed. In a specific embodiment, the electrical lead can include a flexible circuit.

[0015] In yet another exemplary embodiment of these endoscopes, the light emitter can be carried at the distal end of the shaft, and (one or more) second electrical leads 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 shaft portion can also be carried on a second reel and can include a flexible circuit.

[0016] 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 contracted shape and a non-contracted shape to accommodate the introduction of a tool through the channel. As with the first endoscope embodiment described above, the combined diagonal dimension and channel diameter will typically be greater than the shaft outer diameter. Other specific aspects of the reconfigurable channel described above with respect to the earlier embodiments can also be found in the endoscope of the second aspect of this document.

[0017] In a third aspect of the invention, an endoscope includes a handle and an elongated shaft. The elongated shaft is mounted to be generally reversibly rotated at least 180° around the longitudinal axis of the handle. An electronic image sensor is carried near the distal end of the shaft, and an electrical lead extends from the image sensor to the handle. The electrical lead is configured to coil and unwind (wind and unwind) on the shaft when the shaft is rotated in opposite directions about the longitudinal axis. In a specific embodiment of this third endoscope structure, the electrical lead may include a flexible circuit, and at least a portion of the flexible circuit may have a cross-sectional area less than 5% of the cross-sectional area of ​​the shaft assembly.

[0018] In a fourth aspect of the invention, an endoscope includes a handle in an elongated shaft that is mounted to rotate at least 180° around 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 in the handle and a distal channel portion that rotates with the shaft. A fluid-tight housing between the proximal channel portion and the distal channel portion is configured to provide a fluid-tight path through the channel portion over the entire rotation range of the shaft.

[0019] 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 also includes 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 component and a distal channel portion that rotates in the shaft as the flow channel rotates in the housing. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Additional aspects of the invention will become apparent from the following description of illustrative embodiments and from the accompanying drawings, in which:

[0021] Figure 1 Components of a hysteroscopic treatment system corresponding to the present invention are illustrated, including a perspective view of an endoscopic viewing system and a schematic diagram of a fluid management system.

[0022] Figure 2 yes Figure 1 A perspective view of an endoscopic viewing system showing a single-use endoscope component separated from a reusable handle component.

[0023] Figure 3A yes Figure 2 A perspective view of a disposable endoscope component with the handle housing partially removed to show the interior of the component.

[0024] Figure 3B yes Figure 3A A perspective view of an endoscope component with the flow channel housing removed to illustrate features of the rotating shaft assembly.

[0025] Figure 4 At different angles Figure 1 A perspective view of an endoscopic viewing system illustrating the rotation of a rotating shaft assembly.

[0026] Figure 5 yes FIG. 3A to FIG. 3B Another perspective cross-sectional view of an endoscope component of FIG. 1 with the flow channel housing removed to illustrate the central axis of the working channel about which the shaft assembly rotates and the eccentric longitudinal axis of the outer sleeve of the endoscope shaft.

[0027] 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.

[0028] Fig. 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.

[0029] Figure 7B yes Fig. 7A Another view of the distal end of an endoscope shaft showing the distal working channel portion in an enlarged cross-sectional configuration as a tool is introduced through the working channel.

[0030] Figure 8 yes FIG. 7A to FIG. 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 cannula tip. DETAILED DESCRIPTION

[0031] Figure 1 A hysteroscopic treatment system 50 corresponding to the present invention is illustrated, which includes a plurality of components including an endoscopic viewing system 100 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 to view images provided by the endoscopic viewing system 100.

[0032] More specifically, Figure 1 and Figure 2 The endoscopic viewing system 100 includes a reusable handle component 120 having a finger-actuated control pad 122, and a disposable endoscope component 125 having an elongated endoscope shaft 126 carrying a distal electronic imaging sensor 128 (see Figure 1 and Fig. 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 container 144, which may include a fluid deficiency measurement subsystem as known in the art. Each of the system and subsystems will be described in more detail below.

[0033] refer to Figure 1 , Figure 2 and Figure 3B , it can be seen that the endoscope observation system 100 includes a handle component 120 and a detachable disposable endoscope component 125. Figure 2 In FIG. 1 , the disposable endoscope component 125 may be viewed as a component of a proximal handle housing 145 that carries a rotating shaft assembly 150 configured for rotating the handle housing 145 .

[0034] refer to Figure 1 , Figure 3B and Figure 5, the rotating shaft assembly 150 includes a proximal cylindrical handle 152 coupled to a molded rotating core 155, which is in turn coupled to an elongated outer sleeve 160 extending to a distal working end 162 of the endoscope component 125 ( 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. As shown in Figure 5 and Fig. 7A As seen in FIG. 1 , the outer sleeve 160 has a central longitudinal axis 175 that is offset from the longitudinal axis 165 about which the shaft assembly 150 rotates. Figure 4 The grip 152 is shown having a visual marker 178 aligned with the offset distal end portion 185 to allow the operator to know the orientation of the image sensor 128 by viewing the grip 152 .

[0035] exist Figure 1 , Figure 4 , Figure 6 and Fig. 7A , the endoscope shaft 126 can be seen, and more particularly, the outer sleeve 160 extends in a straight proximal sleeve portion 180 to an offset distal end portion 185, the axis 182 of the distal end portion 185 also being offset from the central axis 175 of the outer sleeve 160 by 2 mm to 10 mm ( Fig. 7A ). The outer sleeve 160 has a transition portion 186 that extends between the straight proximal sleeve portion 180 and the offset distal tip portion 185 at an angle 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 portion 185 (see Fig. 7A ). Figure 5 and Figure 7BAs can be seen in the endoscope component 125 and more particularly 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 diameter of the elongated outer sleeve 160 at each of the straight, transition and distal end portions (180, 186 and 185, respectively) is between 4 mm and 10 mm, and its total length is configured for hysteroscopy. More typically, the diameter of the endoscope shaft 126 is 5 mm to 6 mm. It has been found that the endoscope shaft 126 having an angled transition portion 186 and an offset distal end portion 185 can be introduced through the patient's cervical canal without the need for expansion beyond the profile or diameter SD of the straight proximal sleeve portion 180. In other words, when the shaft is advanced through the cervical canal, the tissue surrounding the patient's cervical canal conforms to the angle in the endoscope shaft 126.

[0036] In one variation, the handle housing 145 of the endoscope component 125 is adapted to be slidably and removably engaged with the handle component 120, such as in Figure 2 and Figure 4 120. It will be readily appreciated that, when assembled, an operator can hold the pistol grip handle assembly 120 with one hand and rotate the cylindrical rotating grip 152 with the fingers of the other hand to rotate the endoscope shaft and image sensor 128 to orient the viewing angle of the image sensor 128 and tool 188 to any desired rotational angle. As described below, the rotating shaft assembly 150 can be rotated at least 180°, and more often 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 up, side, or down orientation relative to handle housing 145 .

[0037] As in Figure 2 As can be seen in FIG. 1 , 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. Figure 2 The endoscope component 125 is illustrated as being configured to be axially slidably engaged with the handle component 120, but it should be understood that the angled pistol grip portion 192 of the handle component 120 can be inserted into the endoscope component 125 in a different arrangement, such as a male-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 includes a sterile device for use in a sterile field, while the handle component 120 may not be sterile and is generally suitable for use in a non-sterile field. The 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 ).

[0038] As in Figure 1 and Figure 2 As can be seen in the figure, the endoscope component 125 includes a fluid inlet tube 200A and a fluid outlet tube 200B that are connected to the fluid management system 105. The fluid management system 105 is Figure 1 It is schematically shown in FIG. Figure 2 , Figure 3A and Figure 3B It will be appreciated that the endoscope handle housing 145 may be comprised of two injection molded plastic shell elements 204a and 204b (see Figure 4 ) and Figure 3A One housing element 204a is shown removed to show the interior of the handle housing 145. As can be seen, both the inflow tube 200A and the outflow tube 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.

[0039] Figure 3B is similar to Figure 3A , with the second housing element 204b removed and the fluid channel housing 205 also removed (perspective view) to illustrate how the stationary inlet and outlet tubes 200A, 200B communicate with the inlet and outlet paths in the rotating shaft assembly 150 that is rotated at least 180°.

[0040] refer to Figure 3A and Figure 3B It can be seen that 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 grip 152 for rotating the rotating core 155 in the fluid channel housing 205.

[0041] The rotating core 155 includes a first flange 218a, a second flange 218b, and a third flange 218c defining annular flow passages 220 and 222 therebetween. It can be seen that 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 appreciated that the rotating flanges 218a - 218c rotate within the bore 208 of the flow passage housing 205 and the O-rings 224a - 224c maintain a fluid seal between the annular flow passages 220 and 222 .

[0042] Reference again Figure 3Aand 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 to communicate with the annular flow passage 205. Therefore, each of the annular flow passages 222 and 220 can be rotated up to 360° and communicate with the fixed distal ends of the inflow tube 200A and the outflow tube 200B.

[0043] Figure 3B It is further shown how the annular flow passages 222 and 220 communicate with a separate flow passage extending through the interior of the elongated sleeve 160 to the working end 162 of the endoscope shaft 126. Figure 3B 2, the fluid inflow path can be seen, which extends within the second annular channel 222 through an annular gap AG on the outside of the inner sleeve portion 235 surrounding the rotating core 155. Such annular gap AG extends distally to communicate with the inner bore 242 of the outer sleeve 160. In one variation, the path within the inner bore 242 transitions to an inflow sleeve 244 having a distal outlet 245, as shown in FIG. FIG. 7A to FIG. 7B shown.

[0044] 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 is in communication 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 1, 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 the tool 188 to be introduced therethrough. Many types of seals are known in the art, such as silicone sleeve seals, flap valve seals, etc. Typically, when a tool is introduced through the working channel 170, the tool itself will provide an outflow channel. Therefore, when using the endoscope without a tool in the working channel, using the working channel 170 as an outflow channel is suitable for diagnostic procedures.

[0045] In the method of use, the endoscope shaft 126 can be manipulated through the patient's endocervical canal, wherein the inflow pump 140A and the outflow pump 140B are operated (see Figure 1 ) to provide continuous flushing through the distal end portion 185 of the endoscope component 125 while endoscopically viewing through the image sensor 128. Thus, such a variation would allow fluid inflow through the annular channel 222 and fluid outflow through the working channel 170 and the annular channel 220.

[0046] Now go to FIG. 7A to FIG. 7B, the endoscope shaft 126 has a small insertion profile or configuration, which is composed of the outer diameter of the elongated outer sleeve 160, which includes a proximal straight portion 180, an angled transition portion 186 and a distal tip portion 185 ( Fig. 7A ).exist Fig. 7A As can be seen in the figure, the distal tip portion 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. In order to provide the large number of electrical leads required by the image sensor 128, it was found that the conventional multi-wire electrical cable was too large to be accommodated by the small diameter outer sleeve 160, which also accommodates the working channel 170, the inflow channel 244 and possibly other fluid flow channels. For this reason, it was found that the flat strip 265 ( Figure 5 ) in the form of a printed flexible circuit can provide 10 to 40 electrical leads and occupy only a thin planar space within the endoscope shaft 126. Fig. 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 Fig. 7A In one variation shown, a second flexible circuit strip 270 is provided to power the LEDs 260. In another variation, the first flexible circuit strip 265 can potentially carry electrical leads to the image sensor 128 and the two LEDs 260.

[0047] Now go to Figure 3A , Figure 3B and Figure 5 , illustrating providing the required slack in the circuit or flexible circuit strips 265 and 270 to accommodate the rotation of the shaft assembly 150 relative to the handle housing 145 ( Figure 3A ) of the rotating mechanism. Figure 3B and Figure 5 As best seen in , the rotating shaft assembly 150 includes a first or distal spool 280 around which the flexible circuit ribbon 265 can be wrapped or coiled. 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. FIG. 3A to FIG. 3B The variation shows the endoscope handle housing the flexible circuit ribbon 265 in a reel 280, but it should be understood that the slack portion of the flexible circuit ribbon can be configured in at least one of a coiled form, a spiral form, or a folded form without a reel.

[0048] In one aspect of the present invention, reference Fig. 7A , an endoscope shaft 126 carrying a distal image sensor 128 is provided, wherein the diameter of the 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 include a flexible circuit 265. In such a variation, the flexible circuit ribbon has a thickness of less than 0.4 mm and a width of less than 5.0 mm. More often, the flexible circuit ribbon has a thickness of less than 0.3 mm and a width of less than 4.0 mm. In addition, in this variation, the flexible circuit ribbon carries at least 10 electrical leads, and typically more than 15 electrical leads. On the other hand, the electrical conductors extending to the image sensor 128 are in a cable or ribbon having a cross-section that is less than 5% of the cross-section of the endoscope shaft 126. In another aspect of the invention, an endoscope comprises: a shaft carrying a distal image sensor extending through a working channel of the shaft, wherein the working channel in the distal shaft portion is reconfigurable between a retracted shape and a non-retracted shape to accommodate a tool introduced therethrough, wherein the combined diagonal dimension DD of the sensor and the diameter WCD of the working channel 170 in its inserted configuration or profile is greater than the shaft diameter SD (see Figure 4 , Figure 6 and Fig. 7A ).

[0049] In a particular embodiment, the image sensor 128 can be purchased from OmniVision, Inc., 4275 Burton Drive, Santa Clara, California, 95054, part name / number: High Definition Sensor OV9734 with 1280 x 720 pixels. The package dimensions of the sensor 128 are 2532 μm x 1722 μm, and the diagonal DD is 3062 μm or 3 mm. In addition, the proximal shaft (outer) diameter SD is 5 mm, and the working channel diameter WCD is 3 mm. Therefore, the combined sensor diagonal DD (3 mm) and working channel diameter WCD (3 mm) are equal to 6 mm, which is greater than the shaft outer diameter of 5 mm. In this example, the flexible circuit tape has a width of 3.4 mm, a thickness of 0.2 mm, and a cross-sectional area of ​​0.68 mm 2 , the cross-sectional area is the cross-sectional area of ​​19.63mm 23.52% of the 5 mm diameter shaft. In this particular variation, the flexible circuit ribbon 265 carries 19 electrical leads.

[0050] Reference again FIG. 7A to FIG. 7B The distal portion of the endoscope shaft 126 includes a distal working channel portion 170', which can be Fig. 7A The first smaller cross section for accommodating the outflow of fluid is shown in FIG. Figure 7B The reconfiguration is shown between a second larger cross-section for accommodating a tool 188 introduced through the working channel 170 and its distal portion 170'.

[0051] In such Figure 3A-3B , Figure 5 , Figure 6 and Fig. 7A In one variation shown, it can be seen that the working channel sleeve 174 defining the working channel 170 extends in a straight configuration through the endoscope component 125 from its proximal opening port 172 to its distal tip 290. Fig. 7A and Figure 7B 1, 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 or lower sleeve portion 296 and, in one variation, 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 portion 186 of the proximal straight sleeve portion 180, the distal tip portion 185, and the distal portion 312 ( Figure 7B ). Therefore, it can be Fig. 7A As can be seen in FIG. 1 , the elastomeric sleeve 310 has sufficient elastic strength to collapse or contract the working channel portion 170 ′ to a smaller cross-section, such as in FIG. Fig. 7A Seen in.

[0052] As in Fig. 7A As can be seen in the figure, the lower sleeve portion 296 includes a sleeve wall 315 having sufficient curvature to maintain an open path through the distal working channel portion 170' when the elastomeric sleeve 310 contracts the distal channel portion 170', thereby always providing an open fluid outflow path. For example, the sleeve wall 315 can have a curvature representing the same diameter as the proximal portion of the sleeve 174 and extend over a radial angle ranging from 30° to 90°. Although Fig. 7A The illustrated lower sleeve portion 296 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 combination of plastic and metal.

[0053] Next, Figure 7B The distal working channel portion 170' is shown in its second expanded configuration when the physician inserts the elongated tool 188 (perspective view) through the working channel 170. Such a tool 188 will first slide along the hinge portion 298 of the lower sleeve 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 a tensioned position, such as Figure 7B As tool 188 is withdrawn from working channel portion 170', elastomeric sleeve 310 will be Figure 7B The tensioning position returns to Fig. 7A to a stationary or untensioned position to return the working channel portion 170' to Fig. 7A The shrink configuration.

[0054] In general, an endoscope assembly 125 corresponding to the present invention allows the use of an image sensor 128 having a larger diagonal dimension relative to the insertion profile or diameter of the endoscope shaft 126, while providing a working channel 170 having a larger 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 portion 185, an image sensor 128 having a diagonal dimension DD carried by the distal sleeve portion 185, and a working channel 170 having a diameter WCD extending through the elongated shaft 126, wherein the shape of the working channel portion 170' in the distal end of the shaft 126 is adjustable to accommodate a tool 188 introduced therethrough, and wherein the diagonal dimension DD and the working channel diameter WCD of the combination or sensor are greater than the shaft diameter SD (see Fig. 7A ).

[0055] In one variation, the sensor diagonal dimension DD is greater than 50% of the shaft diameter SD or greater than 60% of the shaft diameter. In one variation, 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. FIG. 7A to FIG. 7B In a variation of this, a working channel portion 170' in the distal region of the endoscope shaft 126 is adjustable between a partially retracted shape and a non-retracted shape.

[0056] In one variation, reference Fig. 7A , the distal end portion 185 of the endoscope shaft 126 has an axial dimension D1 in the range of 5 mm to 20 mm. Fig. 7A, the angled transition sleeve portion 186 extends over a similar axial dimension D2 in the range of 5 mm to 20 mm. Still referring to Fig. 7A , the central axis 182 of the distal tip portion 185 can be parallel to and offset from the longitudinal axis 175 of the straight shaft portion 180 by a distance in the range of 1 mm to 10 mm.

[0057] 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, Fig. 7A and Figure 7B In the illustrated variation, two LEDs, indicated at 260, are shown carried in opposite sides of the sensor housing 340. Of particular interest is the distal-most surface 350 of the lens assembly 345 and the LEDs 260, as shown in FIG. Figure 8 7 is shown disposed distally outwardly from the distal surface 352 of the distal tip portion 185. It has been found that providing such a distal-most surface 350 of the lens assembly and the LED outwardly from the distal surface 352 of the distal tip portion 185 improves the illumination from the LED 260 and improves the field of view of the image sensor 128. The distance indicated at D3 in FIG7 ranges from 0.2 mm to 2.0 mm.

[0058] Reference Fig. 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. Fig. 7A As seen in FIG. 1 , the distal end of the pressure sensing channel 360 is open in the distal end surface 352 of the endoscope shaft 126. The pressure sensing channel 360 may extend to a disposable pressure sensor (not shown) in the handle housing 145. Such a disposable pressure sensor may then couple electrical leads 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, disposable endoscope component 125 carries a disposable pressure sensor coupled to remote control 110A via a detachable connector.

[0059] In one variation of the pressure sensing mechanism, reference Fig. 7A, the wall of the pressure sensing channel 360 is composed of a hydrophobic material, which can be any suitable polymer, such as PFTE, having an inner diameter in the range of 0.25 mm to 2.5 mm. The diameter of the channel 360 is typically 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 the air column in the channel connected to the pressure sensor. Since the channel diameter is very small, the compressibility of the air column in the pressure sensing channel 360 will not significantly affect the sensed pressure. In another variation, the metal sleeve can be coated with a hydrophobic surface or a super hydrophobic surface.

[0060] Reference now Figure 1 , Figure 2 and Figure 4 , it can be seen that the handle portion 120 has an angled pistol grip portion 192 having an axis 194 that is angled 10° to 90° away from the axis 175 of the endoscope shaft 126. The grip portion 192 includes a finger 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 mentioned above, the control unit 108 typically carries the image processor 110B. However, the interior of the handle portion 120 may also carry the image processor 110B or its processing components.

[0061] Figure 4 The handle component 120 and the endoscope component 125 are shown at different angles, where it can be seen that the grip portion 192 has a recessed channel 385 therein adapted to receive and lock in place the inflow tube 200A and the outflow tube 200B so that the tube set is integrated with the pistol grip 192 during use. This feature is important so that the inflow and outflow tubes do not interfere with the operation of the endoscope component 125 or the tools introduced through the working channel 170. The pistol grip 192 can have a single recessed channel 385 to accept both the inflow and outflow tubes or two recessed channels for receiving the inflow and outflow tubes, respectively.

[0062] Now go to Figure 6, an enlarged view of the assembled handle component 120 and endoscope component 125 shows a control pad 122 with four actuator buttons or switches suitable for operating the system. In one variation, actuator 402 is suitable for turning irrigation on and off, or in other words, actuating the fluid management system 105 to provide fluid inflow and fluid outflow. Actuator 404 is suitable for image or video capture. In one variation, momentary pressing of actuator 404 will capture a single image, and longer pressure on the actuator will operate video recording.

[0063] 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 then 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 embodiment, the scroll button 406 can be actuated to cycle between the following subsystems and features: (i) fluid inflow / outflow rates from the fluid management system 105; (ii) set pressures to be maintained by the fluid management system 105; (iii) low fluid alarms calculated by the fluid management system 105; (iv) optional selection of still image capture or video capture, and (v) LED light intensity. Then, after scrolling to select a subsystem, the physician can actuate the central or 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 form of a display. Figure 1 112. Thus, it will be appreciated that the physician can operate the scroll button 406 to scroll through and select any subsystem or feature while viewing, for example, the selection on the display 112, and then actuate the up / down actuator 410 to adjust the operating parameters which can also be viewed on the display 112.

[0064] In another aspect of the present invention, the controller 110A includes a control algorithm for operating the control panel 122 that provides for jumping back to a default state after the physician has used the scroll button or actuator 406. For example, the default condition will be a selected default subsystem that can be actuated by the central or up / down actuator 410. In one variation, the default subsystem is the fluid inflow / outflow rate, which may be the subsystem most commonly 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 the various subsystems or change the parameters within a predetermined time interval, the control algorithm will jump back to the default subsystem, which may be the fluid inflow / outflow rate. The predetermined time interval or timeout for the control algorithm to jump back to the default condition may be anywhere between 1 second and 10 seconds, more commonly between 2 seconds and 5 seconds.

[0065] Still refer to Figure 6 , the assembly of the handle component 120 and the endoscope component 125 is shown with plane P to illustrate the sterile area 415 and the non-sterile area 420 relative to the endoscope assembly. It is understood that the disposable endoscope component 125 is sterilized, and the doctor or nurse will remove the component 125 from the sterile packaging and then define the sterile area 415. Then, the endoscope component 125 will be matched with the handle component 120 defining the non-sterile area 420. In other variations (not shown), a plastic film or other plastic shell can cover the handle portion 120.

[0066] from Figure 6 It will also be appreciated that the method of the present invention. 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, which tapers into the proximal port 172 of the working channel 170. In one variation, the diameter of the recess R is at least 15 mm, and is typically greater than 20 mm. The depth of the recess may range from 5 mm to 20 mm or more. Therefore, it can be appreciated that the physician can easily insert the distal end 425 of the tool 188 into the mouth of the large diameter recess R without any risk of contacting the non-sterile handle portion 120. Thereafter, the physician can move the tool distally over the surface 428 of the recess R, into and through the port 172 of the working channel 170. By using this method, the physician can ensure that the tool 188 will not contact the non-sterile area 420.

[0067] 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 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, which is only for convenience, and any feature may be combined with another feature according to the present invention. Many variations and substitutions will be apparent to those of ordinary skill in the art. Such substitutions and variations are intended to be included within the scope of the claims. The specific features set forth in the dependent claims may be combined and fall within the scope of the present invention. The present invention also includes embodiments, as if the dependent claims were written alternatively in the format of multiple dependent claims with reference to other independent claims.

[0068] Other variations are within the spirit of the invention. Therefore, while the invention is susceptible to various modifications and alternative constructions, certain illustrated embodiments thereof are shown in the drawings and have been described in detail above. However, it should be understood that there is no intention to limit the invention to the specific form or forms disclosed, but on the contrary, it is intended to cover all modifications, alternative constructions, and equivalents that fall within the spirit and scope of the invention as defined by the appended claims.

[0069] In the context of describing the present invention (especially in the context of the appended claims), the use of the terms "one", "a kind of" and "the" and similar references should be interpreted as covering singular and plural forms, unless otherwise indicated herein or clearly contradicted by the context. Unless otherwise indicated, the terms "include", "have", "include" and "contain" should be interpreted as open terms (i.e., meaning "including but not limited to"). The term "connection" should be interpreted as being partially or completely included, attached to or combined together, even if there are intervening objects. Unless otherwise indicated herein, the enumeration of numerical ranges herein is only intended to be used as a shorthand method for referring to each individual value falling within the range, respectively, and each individual value is incorporated into the specification as if it is quoted separately herein. Unless otherwise indicated herein or clearly contradicted by the context, all methods described herein can be performed in any suitable order. Unless otherwise required, the use of any and all examples or exemplary language (e.g., "such as") provided herein is only intended to better illustrate the embodiments of the present invention, and is not intended to limit the scope of the present invention. Any language in the specification should not be interpreted as indicating that any unclaimed element is essential for implementing the present invention.

[0070] 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.

Claims

1. An endoscope, comprising: a shaft having a shaft outer diameter, a distal shaft portion, a proximal shaft portion, and a longitudinal axis between the distal shaft portion and the proximal shaft portion; a handle coupled to the proximal portion of the shaft and having a handle axis and an electrical connector secured to the handle, wherein the longitudinal axis of the shaft is aligned with the handle axis, and wherein the shaft is configured to rotate at least about 180° about the handle axis; an image sensor having a diagonal dimension, the image sensor being carried by the distal portion of the shaft; a light emitter carried at a distal end of the shaft; a first electrical lead in the form of a flat strip extending from the image sensor to the electrical connector fixed in the handle, wherein the first electrical lead is flexible and is configured with a first slack portion inside the handle to accommodate rotation of the shaft, and one end of the first slack portion is carried on a first reel and extends about the longitudinal axis of the shaft; a second electrical lead in the form of a flat strip extending from the light emitter to a second connector secured in the handle, wherein the second electrical lead is flexible and is configured with a second slack portion within the interior of the handle member to accommodate rotation of the shaft, and one end of the second slack portion is carried on a second reel and extends about the longitudinal axis of the shaft; as well as a passage extending through at least the distal shaft portion and having a passage diameter, Wherein a portion of the channel in the distal shaft portion is reconfigurable between a constricted shape and a non-constricted shape to accommodate a tool introduced therethrough, and wherein a combined diagonal dimension and channel diameter is greater than the shaft outer diameter.

2. The endoscope of claim 1, wherein the diagonal dimension is at least 50% of the outer diameter of the shaft.

3. The endoscope of claim 1, wherein the diagonal dimension is at least 60% of the outer diameter of the shaft. The endoscope of claim 1 , wherein the channel diameter is at least 50% of the shaft outer diameter.

5. The endoscope of claim 1, wherein the channel diameter is at least 60% of the shaft outer diameter.

6. The endoscope of claim 1, further comprising a fluid inflow source for providing fluid flow through an inflow channel in the shaft to an outlet in the distal shaft portion.

7. The endoscope of claim 6, further comprising a negative pressure source for providing fluid outflow through an outflow channel in the shaft using the opening in the distal shaft portion.

8. The endoscope of claim 7, further comprising a controller for controlling fluid flow through the inflow channel and the outflow channel, and at least one actuator in the handle for regulating fluid inflow and fluid outflow.

9. The endoscope of claim 8, wherein the controller comprises an algorithm for operating the fluid inflow source and the negative pressure source, the algorithm being adapted to maintain the fluid pressure within a set pressure range of the working space.

10. The endoscope of claim 1, wherein the first spool and the second spool are spaced apart from each other on the handle axis.

11. An endoscope comprising: a handle having an interior, a handle axis, and an electrical connector secured to the handle; a shaft having a longitudinal axis, the shaft coupled to the handle and configured to rotate at least about 180° about the handle axis; an electronic image sensor carried at a distal end of the shaft; a first electrical lead in the form of a flat strip extending from the image sensor to the connector secured in the handle, wherein the first electrical lead is flexible and configured with a first slack portion within the interior of the handle to accommodate rotation of the shaft, and wherein one end of the first slack portion is carried on a first reel and extends about the longitudinal axis of the shaft; a light emitter carried at a distal end of the shaft; A second electrical lead in the form of a flat strip extending from the light emitter to a second connector fixed in the handle, wherein the second electrical lead is flexible and is configured with a second slack portion within the interior of the handle to accommodate rotation of the shaft, and one end of the second slack portion is carried on a second reel and extends around the longitudinal axis of the shaft. 12 . The endoscope according to claim 11 , wherein the first loose portion or the second loose portion has at least one of a coiled form, a spiral form, or a folded form.

13. The endoscope of claim 11, wherein the first spool is concentric with the axis of the shaft.

14. The endoscope of claim 11, wherein the first electrical lead comprises a flexible circuit.

15. The endoscope of claim 11, wherein the second electrical lead comprises a flexible circuit.

16. The endoscope of claim 11, further comprising a channel in the shaft, wherein a portion of the channel is reconfigurable between a collapsed shape and a non-collapsed shape to accommodate a tool introduced therethrough.

17. The endoscope of claim 16, wherein the combined diagonal dimension and channel diameter is greater than the shaft outer diameter.

18. The endoscope of claim 11, further comprising a fluid inflow source for providing fluid flow through an inflow channel in the shaft to an outlet in the distal shaft portion.

19. The endoscope of claim 18, further comprising a negative pressure source for providing fluid outflow through an outflow channel in the shaft using the opening in the distal shaft portion.

20. The endoscope of claim 19, further comprising a controller for controlling fluid flow through the inflow channel and the outflow channel and at least one actuator in the handle for regulating fluid inflow and outflow.

21. The endoscope of claim 20, wherein the controller comprises an algorithm for operating the fluid inflow source and the negative pressure source, the algorithm being adapted to maintain the fluid pressure within a set pressure range of the working space.

22. The endoscope according to claim 11, Wherein the first electrical lead or the second electrical lead is configured to be coiled and uncoiled on the shaft when the shaft is rotated in opposite directions about the longitudinal axis.

23. The endoscope of claim 22, wherein the first electrical lead or the second electrical lead comprises a flexible circuit, and wherein a cross-sectional area of ​​at least a portion of the flexible circuit is less than 5% of a cross-sectional area of ​​the shaft assembly.

24. The endoscope of claim 11, further comprising: a flow channel extending through the shaft to a port in a distal end of the shaft, wherein the flow channel has a proximal channel portion fixed in the handle and a distal channel portion that rotates in the shaft; as well as A fluid-tight housing is provided between the proximal channel portion and the distal channel portion, the fluid-tight housing being adapted to provide a fluid-tight path through the channel portions within a range of rotation of the shaft.

25. The endoscope of claim 24, wherein the shaft includes an annular flow channel that rotates in the housing.

26. The endoscope of claim 25, further comprising a second flow channel extending through the handle member and the shaft assembly, wherein the second flow channel has a proximal channel portion fixed in the handle member and a distal channel portion rotating in the shaft and adapted to rotate in the housing.

27. The endoscope of claim 11, wherein the first spool and the second spool are spaced apart from each other on the handle axis.

Images