Patent Description:
Endoscopic systems of the invention intended for hysterectomy typically comprise a base station having an image display, a disposable endoscope component with an image sensor, a reusable handle component that is connected to an image processor in base station, and a fluid management system integrated with the base station and handle component. The endoscope component and the re-useable handle are typically referred to as a hysteroscope.

Of particular interest to the present invention, hysteroscopes and other endoscopes 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 a distal portion of the shaft through the patient's cervix.

Of further interest to the present invention, hysteroscopes may have a shaft rotatable relative to the handle, and that shaft will often carry a camera and light source that need to be externally connected through the handle.

Of still further interest to the present invention, rotatable hysteroscope shafts may also carry fluids through a lumen which has an external port fixed in the handle.

For these reasons, it would be desirable to provide improved hysteroscopes which can accommodate the introduction of comparatively large tools though a shaft with a relatively low profile. It would be further desirable to provide improved hysteroscopes which can accommodate the connection of cameras, light sources, and the like, on rotatable shafts through stationary handles. It would be still further desirable to provide improved hysteroscopes which can accommodate the flow of fluids through rotatable shafts coupled to stationary handles. At least some of these objectives will be met by the inventions described hereinbelow.

Description of the Background Art. Hysteroscopic systems of a type similar to that illustrated herein are described in commonly owned, co-pending applications: <CIT>; <CIT>; <CIT>; and <CIT>.

Furthermore, <CIT> discloses a hysteroscopy device with an image capturing structure located at a distal end of an elongated member and communicating video signals with a monitor. The elongated member and the image capturing structure being dimensioned for insertion into the patient's uterus through cervix, wherein the image capturing structure is connected to the distal end of the elongated member by means of an elastically deformable element. Further document <CIT> discloses an endoscope having a working channel with flexible side portions at its distal end to increase the cross-section on insertion of an elongated tool.

So as to address at least some of the aforementioned issues, the present invention provides for an endoscope as defined by claim <NUM>. Preferred embodiments of the invention are laid down in the dependent claims.

In a first aspect of the present invention, a hysteroscope or other endoscopic system comprises a shaft having an outer shaft diameter, a distal shaft portion, a proximal shaft portion, and a longitudinal axis there between. A handle is coupled to the proximal portion of the shaft, and an image sensor with 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 section of the channel in the distal portion of the shaft is re-configurable between a constricted shape or geometry and a non-constricted shape or geometry to accommodate a tool introduced there through. Because of the re-configurable nature of the distal portion of the channel, the combined diagonal dimension and channel diameter may be greater than the outer shaft 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 present invention will be found in endoscopes comprising fixed handle-shaft structures as well.

In certain exemplary embodiments of the endoscopes of the present invention, the diagonal dimension will be at least <NUM>% of the outer shaft diameter, typically being at least <NUM>%, or greater. In further exemplary embodiments, the channel diameter will also be at least <NUM>% of the outer shaft diameter, more often being at least <NUM>% of the outer shaft diameter, or greater.

In other exemplary embodiments, the endoscopes of the present invention will be provided in systems which further comprise 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. Usually, such systems will further comprise a negative pressure source for providing fluid outflows through the outflow channel in the shaft and an opening in the distal shaft portion. Still further, the systems may comprise a controller for controlling fluid flows through the inflow and outflow channels and at least one actuator in the handle for adjusting fluid inflows and outflows. For example, the controller may be configured with algorithms for operating the fluid inflow source and the negative pressure source to maintain fluid within a set pressure range in a working space, such as the uterine cavity.

In a second aspect of the present invention, a hysteroscope or other endoscope comprises a handle having an interior, an axis, and an electrical connector fixed to the handle. A shaft is removably or otherwise coupled to the handle and configured to rotate, typically reversibly rotate, about a longitudinal axis relative to the handle through an arc of about <NUM>° 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 the electrical connector in the handle. The electrical lead(s) are flexible and configured with a "slack" portion in the interior of the handle to accommodate rotation of the shaft. By "slack," it is meant that the length of the electrical lead(s) is greater than the distance between the electrical connector and the point of attachment of the electrical lead(s) to the shaft so that the shaft may be rotated without over tensioning the electrical lead(s).

In further exemplary embodiments of this endoscope, the slack portion may be formed as any one of a coil, a spiral, a folded structure, a serpentine structure, or the like. In specific embodiments, one end of the slack portion will be coupled to and extend around the axis of the rotating shaft assembly, typically being carried on a spool secured to the shaft assembly. The spool is usually aligned concentric or co-axially with the axis of the shaft so that as the shaft is rotated, the spool may take up or let out the flexible electrical leads as needed. In specific examples, the electrical leads may comprise the flex circuits.

In still further exemplary embodiments of these endoscopes, a light emitter may be carried at the distal end of the shaft and second electrical lead(s) may extend from the light emitter to a second electrical connector fixed in the handle. The second electrical leads are configured with a second slack portion to accommodate rotation of the shaft. The second shaft portion may also be carried on a second spool and may comprise a flex circuit.

In the present invention, a channel is formed in the shaft where a portion of the channel is re-configurable between a constricted shape and a non-constricted shape to accommodate introduction to a tool through the channel. As with the first endoscopic embodiments described above, the combined diagonal dimension and channel diameter will typically be greater than an outer shaft diameter. Other specific aspects of the re-configurable channel described above with respect to the earlier embodiment may also be found in the endoscopes of the second aspect herein.

In the third aspect of the present invention, an endoscope comprises a handle and an elongated shaft. The elongated shaft is mounted to rotate, typically reversibly, at least <NUM>° 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 (spool and unspool) over the shaft as the shaft is rotated in opposite directions about the longitudinal axis. In specific embodiments of this third endoscope structure, the electrical leads may comprise a flex circuit and at least a portion of the flex circuit may have a cross-sectional area that is less than <NUM>% of the cross-sectional area of the shaft assembly.

In a fourth aspect of the present invention, an endoscope comprises a handle in a elongated shaft mounted to rotate by at least <NUM>° about a longitudinal axis of the handle. A flow channel extends though the shaft assembly to a port in a distal end of the shaft. The flow channel has a proximal channel portion fixed in the handle and a distal channel portion that rotates together with the shaft. A fluid-tight housing intermediate the proximal and distal channel portions is configured to provide a fluid-tight path through the channel portions within the full rotational range of the shaft.

In specific aspects 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 still further include a second flow channel extending through the handle and shaft assembly, where 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.

The present disclosure also includes a method,not part of the present invention, for orienting an image on a display from an endoscope with an image sensor. For example, such a method can include providing an endoscope having a longitudinal axis and a distal image sensor that provides an image on a display;
providing at least one of an accelerometer and gyroscope carried by the endoscope; and acquiring signals from the at least one of an accelerometer and gyroscope caused by rotation of the endoscope relative to the longitudinal axis; rotating the image on the display in response to the signals to correct the orientation to a selected configuration.

The selected configuration can comprise an image-upright configuration and wherein the rotating step comprises manipulating said image electronically.

In one variation of the method, wherein the accelerometer is located within a housing of the endoscope on a rotating component, the method further comprising rotating the distal image sensor independently of a handle of the endoscope and using the accelerometer to determine rotation of the distal image sensor independently of the handle.

The method can further comprise providing at least a second accelerometer carried on a handle of the endoscope, the method further comprising acquiring signals from the second accelerometer and comparing signals from the at least one of the accelerometer and the second accelerometer.

Another variation of an endoscope comprises an endoscope that is electrically coupled to an image display, the endoscope can include an elongated shaft having a housing located at a proximal end of the elongated shaft and an image sensor located at a distal end of the elongated shaft; a handle coupled to the housing of the elongate shaft; a first accelerometer and gyroscope within the housing and coupled to the elongate shaft such that rotation of the elongate shaft rotates the first accelerometer, wherein the first accelerometer and gyroscope are configured to provide signals from the to determine rotation of the image sensor relative to an longitudinal axis of the elongated shaft, wherein the signals permit rotation of an image on the image display.

A variation of the endoscope can include a second accelerometer located within the handle. wherein the image sensor in the insertion profile has a <NUM> to <NUM> degree viewing angle relative to a central axis of the insertion profile.

Endoscopes as described herein can further comprise a flex circuit having a plurality of electrical conductors which are configured to transmit power and image signals to and from the image sensor, the flex circuit including outer dielectric layers that are configured to shield the plurality of electrical conductors from electrical interference.

Additional aspects of the invention will become clear from the following description of illustrative embodiments and from the attached drawings, in which:.

<FIG> illustrates a hysteroscopic treatment system <NUM> corresponding to the invention which comprises multiple components including an endoscopic viewing system <NUM> and a fluid management system <NUM> housed in a base unit or console <NUM>. The base unit <NUM> also carries a controller 110A and power source for operating the system <NUM> and can include an image processor 110B for processing signals from an image sensor carried by the endoscopic viewing system. A display <NUM> can be coupled to the base unit <NUM> for viewing images provided by the endoscopic viewing system <NUM>.

More in particular, the endoscopic viewing system <NUM> of <FIG> and <FIG> includes a reusable handle component <NUM> with a finger-actuated control pad <NUM> and a disposable single-use endoscope component <NUM> with an elongated endoscope shaft <NUM> that carries a distal electronic imaging sensor <NUM> (see <FIG> and <FIG>). The fluid management system <NUM> includes a first peristaltic inflow pump 140A and second peristaltic outflow pump 140B, a fluid source <NUM> and fluid collection reservoir <NUM> which can include a fluid deficit measurement subsystem as is known in the art. Each of the systems and subsystems will be described in more detail below.

Referring to <FIG>, <FIG> and <FIG>, it can be seen that the endoscopic viewing system <NUM> includes a handle component <NUM> and a detachable single-use endoscope component <NUM>. In <FIG>, the single-use endoscope component <NUM> can be seen as an assembly of a proximal handle housing <NUM> which carries a rotating shaft assembly <NUM> that is configured to rotate the handle housing <NUM>.

Referring to <FIG>, <FIG> and <FIG>, the rotating shaft assembly <NUM> includes a proximal cylindrical grip <NUM> that is coupled to a molded rotating core <NUM> that in turn is coupled to elongated outer sleeve <NUM> that extends to the distal working end <NUM> the endoscope component <NUM> (<FIG>). The rotating shaft assembly <NUM> rotates around a rotational axis <NUM>. A working channel <NUM> extends about axis <NUM> through the rotating shaft assembly <NUM> from a proximal port <NUM> (see <FIG> and <FIG>). The working channel sleeve <NUM> that carries the working channel <NUM> can be seen in <FIG>, <FIG> and <FIG>. Thus, the shaft assembly <NUM> rotates about the central longitudinal axis <NUM> of the working channel <NUM>. As can be seen in <FIG> and <FIG>, the outer sleeve <NUM> has a central longitudinal axis <NUM> that is offset from the longitudinal axis <NUM> around which the shaft assembly <NUM> rotates. <FIG> shows that the grip <NUM> has a visual marker <NUM> that is aligned with the offset distal tip section <NUM> to allow the operator to know the orientation of the image sensor <NUM> by observation of the grip <NUM>.

In <FIG>, <FIG>, <FIG> and <FIG>, it can be seen that the endoscope shaft <NUM> and more particularly the outer sleeve <NUM> extends in a straight proximal sleeve portion <NUM> to an offset distal tip section <NUM> with an axis <NUM> that is also from <NUM> to <NUM> offset from the central axis <NUM> of the outer sleeve <NUM> (<FIG>). The outer sleeve <NUM> has a transition section <NUM> that extends at an angle ranging between <NUM>° and <NUM>° over a length of <NUM> to <NUM> between the straight proximal sleeve section <NUM> and the offset distal tip section <NUM>. The imaging sensor <NUM> is disposed at the distal end of the offset tip section <NUM> (see <FIG>). As can be seen in <FIG> and <FIG>, the endoscope component <NUM> and more in particular the working channel <NUM> is adapted to receive an elongate tool <NUM> that can be introduced through the working channel <NUM>. In one variation, the elongated outer sleeve <NUM> in each of the straight, transition and distal tip sections (<NUM>, <NUM> and <NUM>, respectively) has a diameter ranging between <NUM> and <NUM> with an overall length configured for use in hysteroscopy. More commonly, the diameter of endoscope shaft <NUM> is from <NUM> to <NUM> in diameter. It has been found that the endoscope shaft <NUM> with the angled transition section <NUM> and offset distal tip section185 can be introduced through a patient's cervical canal without dilation beyond the dilation necessary for the profile or diameter SD of the straight proximal sleeve section <NUM>. In other words, the tissue around the patient's cervical canal conforms to the angles in the endoscope shaft <NUM> as the shaft is being advanced through the cervical canal.

In one variation, the handle housing <NUM> of endoscope component <NUM> is adapted for sliding, detachable engagement with the handle component <NUM> as can be best seen in <FIG> and <FIG>. As can be easily understood, when assembled, the operator can grip the pistol grip handle component <NUM> with one hand and rotate the cylindrical rotating grip <NUM> with the fingers of the other hand to rotate the endoscope shaft and image sensor <NUM> to orient the viewing angle of the image sensor <NUM> and a tool <NUM> to any desired rotational angle. As will be described below, the rotating shaft assembly <NUM> can be rotated at least <NUM>° and more often at least <NUM>° (<FIG> and <FIG>). In one variation, the shaft assembly <NUM> can be rotated <NUM>° so as to orient the image sensor <NUM> in any superior, lateral or downward direction relative to the handle housing <NUM>.

As can be seen in <FIG>, the handle housing <NUM> carries a projecting electrical connector 190A that is adapted to couple to a mating electrical connector 190B in the handle component <NUM>. While <FIG> illustrates that the endoscope component <NUM> is configured for axial sliding engagement with the handle component <NUM>, it should be appreciated that the angled pistol grip portion <NUM> of the handle component <NUM> could plug into the endoscope component <NUM> in a different arrangement, such as a male-female plug connector or a threaded connector aligned with the axis <NUM> of the angled grip portion <NUM>. As will be described below, the endoscope component <NUM> comprises a sterile device for use in the sterile field, while the handle component <NUM> may not be sterilized and is typically adapted for use for use in a non-sterile field. A cable <NUM> extends from the handle component <NUM> to the base unit <NUM>, imaging processor 110B and controller 110A which includes a power source (see <FIG>).

As can be seen in <FIG> and <FIG>, the endoscope component <NUM> includes fluid inflow tubing 200A and fluid outflow tubing 200B that communicate with the fluid management system <NUM> which is shown schematically in <FIG>. As can be understood from <FIG>, <FIG> and <FIG>, the endoscope handle housing <NUM> can consist of two injection molded plastic shell elements, 204a and 204b (see <FIG>), and <FIG> shows one shell element 204a removed to show the interior of the handle housing <NUM>. It can be seen that both the inflow tubing 200A and outflow tubing 200B are coupled to an injection molded flow channel housing <NUM> with an interior bore <NUM> that is configured to receive a rotating core <NUM> of the rotating shaft assembly <NUM>.

<FIG> is another view similar to that of <FIG> with the second shell element 204b removed and the flow channel housing <NUM> also removed (phantom view) to illustrate how the stationary inflow and outflow tubing, 200A and 200B, communicate with the inflow and outflow pathways in the rotating shaft assembly <NUM> which rotates at least <NUM>°.

Referring to <FIG> and <FIG>, it can be seen that the rotating core <NUM> is centrally aligned with the axis <NUM> of working channel <NUM> and is further coupled to the off-center elongated outer sleeve <NUM> of the endoscope shaft <NUM>. The proximal end <NUM> of the rotating core <NUM> is fixed to the grip <NUM> for rotating the rotating core <NUM> in the flow channel housing <NUM>.

The rotating core <NUM> includes first, second and third flanges 218a, 218b and 218c which define annular flow channels <NUM> and <NUM> therebetween. It can be seen that annular channel <NUM> is disposed between the first and second flanges 218a and 218b. Annular channel <NUM> is disposed between the second and third flanges 218b and 218c. Each of the first, second and third flanges 218a, 218b and 218c carry an outer O-ring 224a, 224b and 224c. From the views of <FIG> and <FIG>, it can be understood how the rotating flanges 218a-218c rotate in the bore <NUM> of the flow channel housing <NUM> and the O-rings 224a-224c maintain a fluid tight seal between the annular flow channels <NUM> and <NUM>.

Again referring <FIG> and <FIG>, it can be seen that the distal end 230a of inflow tubing 200A is fixed in the flow channel housing <NUM> to communicate with annular flow channel <NUM>. Similarly, the distal end 230b of outflow tubing 200B is fixed in the flow channel housing <NUM> to communicate with annular flow channel <NUM>. Thus, each of the annular flow channels <NUM> and <NUM> can rotate up to <NUM>° and communicate with the stationary distal ends of the inflow tubing 200A and outflow tubing 200B.

<FIG> further shows how the annular flow channels <NUM> in <NUM> communicate with separate flow pathways that extend through the interior of the elongated sleeve <NUM> to the working end <NUM> of the endoscope shaft <NUM>. The fluid inflow pathway can be seen in <FIG> which extends through annular gaps AG around the exterior of inner sleeve portion <NUM> of the rotating core <NUM> within the second annular channel <NUM>. Such annular gaps AG extend distally to communicate with the interior bore <NUM> of the outer sleeve <NUM>. In one variation, the pathway within said interior bore <NUM> transitions to the inflow sleeve <NUM> with distal outlet <NUM> as shown in <FIG>.

The fluid outflow pathway also can be seen in <FIG> wherein an opening <NUM> is provided in the inner surface of annular space <NUM> of the rotating core <NUM> which communicates with the interior working channel <NUM>. Thus, the outflow pathway from a working space in one variation comprises the working channel <NUM> which is fully open for fluid outflows when there is no tool <NUM> in the working channel. In <FIG>, it can be seen that a tool seal <NUM> is shown in the proximal region of the working channel <NUM> that seals the channel <NUM> and also permits the tool <NUM> to be introduced therethrough. Many types of seals are known such in the art as silicone sleeve seals, flap seals and the like. Typically, when a tool is introduced through the working channel <NUM>, the tool itself will provide an outflow channel. Thus, the use of the working channel <NUM> as outflow passageway is adapted for diagnostic procedures when using the endoscope without a tool in the working channel.

In a method of use, the endoscope shaft <NUM> can be navigated through a patient's end cervical canal with the inflow and outflow pumps 140A and 140B (see <FIG>) operating to provide continuous irrigation through the distal tip section <NUM> of the endoscope component <NUM> together with endoscopic viewing by means of image sensor <NUM>. Such a variation will thus allow fluid inflows through annular channel <NUM> and fluid outflows through the working channel <NUM> and annular channel <NUM>.

Now turning to <FIG>, the endoscope shaft <NUM> has a small insertion profile or configuration that consists of the outer diameter of the elongated outer sleeve <NUM> which includes the proximal straight section <NUM>, the angled transition section <NUM> and the distal tip section <NUM> (<FIG>). It can be seen in <FIG> that the distal tip section <NUM> carries an image sensor <NUM> and two LEDs <NUM> which require an electrical connection to base unit <NUM>, the controller 110A and imaging processor 110B. In order to provide the large number of electrical leads required for the image sensor <NUM>, it was found that conventional multi-wire electrical cables were too large to be accommodated by the small diameter outer sleeve <NUM> which also accommodates working channel <NUM>, an inflow channel <NUM> and potentially other fluid flow channels. For this reason, it was found that a printed flex circuit in the form of a flat ribbon <NUM> (<FIG>) could provide from <NUM> to <NUM> electrical leads and occupy only a thin planar space within the endoscope shaft <NUM>. <FIG> shows the flex circuit ribbon <NUM> extending from the image sensor <NUM> proximally within outer sleeve <NUM>. In one variation shown in <FIG>, <FIG>, <FIG> and <FIG>, a second flex circuit ribbon <NUM> is provided to power the LEDs <NUM>. In another variation, the first flex circuit ribbon <NUM> could potentially carry electrical leads to the image sensor <NUM> and to the two LEDs <NUM>.

Now turning to <FIG>, <FIG> and <FIG>, mechanisms are illustrated that provide for needed slack in the electrical circuitry or flex circuit ribbons <NUM> and <NUM> for accommodating rotation of the rotating shaft assembly <NUM> relative to the handle housing <NUM> (<FIG>). As can best be seen in <FIG> and <FIG>, the rotating shaft assembly <NUM> includes a first or distal spool <NUM> around which the flex circuit ribbon <NUM> can be coiled or spooled. The distal spool <NUM> is formed as a part of the rotating core <NUM> of the rotating shaft assembly <NUM>. Any suitable length of the flex circuit ribbon <NUM> can be provided as needed to allow for at least <NUM>° rotation, or more often, <NUM>° of rotation of the rotating shaft assembly <NUM> relative to the handle housing <NUM>. In the variation shown in <FIG> and <FIG>, it can be seen that a second or proximal spool <NUM> comprises a portion of the rotating core <NUM> and is adapted for receiving a slack length of the second flex circuit ribbon <NUM> that extends to the two LEDs <NUM>. In <FIG> and <FIG>, it can be seen that the proximal ends <NUM>', <NUM>' of the flex circuit ribbons <NUM>, <NUM> are coupled to electrical connector 190A by plug connector 288a and 288b. While the variation of <FIG> shows the endoscope handle accommodating the flex circuit ribbon <NUM> in a spool <NUM>, it should be appreciated that the slack portion of the flex circuit ribbon can be configured with at least one of a coiled form, spiral form or folded form without a spool.

In one aspect of the invention, referring to <FIG>, an endoscope shaft <NUM> is provided that carries a distal image sensor <NUM> wherein the diameter of a working channel <NUM> in the shaft <NUM> is greater than <NUM>% of the outer diameter of the shaft <NUM> and the electrical leads to the image sensor <NUM> comprise the flex circuit <NUM>. In such a variation, the flex circuit ribbon has a thickness of less than <NUM> and a width of less than <NUM>. More often, the flex circuit ribbon has a thickness of less than <NUM> and a width of less than <NUM>. Further, in this variation, the flex circuit ribbon carries at least <NUM> electrical leads of often more than <NUM> electrical leads. In another aspect, electrical leads extending to the image sensor <NUM> are in a cable or ribbon that has a cross-section that is less than <NUM>% or the cross-section of the endoscope shaft <NUM>. In another aspect of the invention, the endoscope comprises a shaft carrying a distal image sensor, a working channel extending through the shaft wherein the working channel in a distal shaft portion is re-configurable between a constricted shape and a non-constricted shape to accommodate a tool introduced therethrough, wherein the combined diagonal dimension DD of the sensor and the diameter WCD of the working channel <NUM> is greater than the shaft diameter SD in its insertion configuration or profile (see <FIG>, <FIG> and <FIG>).

In a specific example, the image sensor <NUM> is available from OmniVision, <NUM> Burton Drive, Santa Clara, CA <NUM> with the part name/number: High Definition Sensor OV9734 with a <NUM> x <NUM> pixel count. The sensor <NUM> has package dimensions of <NUM> x <NUM>, with a diagonal DD of <NUM> or <NUM>. Further, the proximal shaft (outer) diameter SD is <NUM> with the working channel diameter WCD being <NUM>. Thus, the combined sensor diagonal DD (<NUM>) and the working channel diameter WCD (<NUM>) equals <NUM> which is greater than the outer shaft diameter of <NUM>. In this example, the flex circuit ribbon is <NUM> in width and <NUM> thickness with a cross-sectional area of <NUM><NUM> which is <NUM>% of the <NUM> diameter shaft having a cross-sectional area of <NUM><NUM>. In this specific variation, the flex circuit ribbon <NUM> carries <NUM> electrical leads.

Referring again to <FIG>, the distal portion of the endoscope shaft <NUM> includes a distal working channel portion <NUM>' that is re-configurable between a first smaller cross-section as shown in <FIG> for accommodating fluid outflows and a second larger cross-section as shown in <FIG> for accommodating a tool <NUM> introduced through the working channel <NUM> and its distal portion <NUM>'.

In one variation as shown in <FIG>, <FIG>, <FIG>, and <FIG>, it can be seen that the working channel sleeve <NUM> that defines working channel <NUM> extends in a straight configuration through the endoscope component <NUM> from its proximal opening port <NUM> to its open distal termination <NUM>. As can be seen in <FIG>, the distal end <NUM> of sleeve <NUM> has a superior surface <NUM> that is straight and rigid. The working channel sleeve <NUM> has an inferior or lower sleeve portion <NUM> that is flexible and in one variation has a living hinge portion <NUM> below sidewall cut-outs 302a and 302b in the sleeve <NUM>. Further, the distal end of the endoscope shaft <NUM> includes an elastomeric sleeve <NUM> that surrounds the angled transition sleeve section <NUM>, the distal tip section <NUM> as well as a distal portion <NUM> of the proximal straight sleeve section <NUM> (<FIG>). Thus, as can be seen in <FIG>, the elastomeric sleeve <NUM> has sufficient elastic strength to collapse or constrict the working channel portion <NUM>' to the smaller cross-section as seen in <FIG>.

As can be seen in <FIG>, the lower sleeve portion <NUM> includes a sleeve wall <NUM> with sufficient curvature to maintain an open pathway through the distal working channel portion <NUM>' when the elastomeric sleeve <NUM> constricts the distal channel portion <NUM>' which thereby always provides an open fluid outflow pathway. For example, the sleeve wall <NUM> can have a curvature representing the same diameter as a proximal portion of sleeve <NUM> and extend over a radial angle ranging from <NUM>° to <NUM>°. While the lower sleeve portion <NUM> shown in <FIG> comprises a portion of the wall of metal sleeve <NUM>, in another variation, the flexible lower sleeve portion <NUM> may be any bendable plastic material or a combination of plastic and metal.

<FIG> next shows the distal working channel portion <NUM>' in its second expanded configuration as when a physician inserts an elongated tool <NUM> (phantom view) through the working channel <NUM>. Such a tool <NUM> will initially slide along the hinge portion <NUM> of the lower sleeve portion <NUM> and then stretch the elastomeric sleeve <NUM> to open distal working channel portion <NUM>' to allow the tool <NUM> to extend through the working channel. In other words, the elastomeric sleeve <NUM> will be stretched or deformed to a tensioned position as shown in <FIG> as a tool is inserted through the distal working channel portion <NUM>'. When the tool <NUM> is withdrawn from the working channel portion <NUM>', the elastomeric sleeve <NUM> will return from the tensioned position of <FIG> to the repose or non-tensioned position of <FIG> to return the working channel portion <NUM>' to the constricted configuration <FIG>.

In general, the endoscope component <NUM> corresponding to the invention allows for the use of an image sensor <NUM> having a large diagonal dimension relative to the insertion profile or diameter of the endoscope shaft <NUM> while at the same time providing a working channel <NUM> that has a large working channel diameter WCD relative to the insertion profile or diameter of the endoscope shaft assembly <NUM>. More in particular, the endoscope component <NUM> comprises endoscope shaft <NUM> having a shaft diameter SD extending to a distal sleeve section <NUM>, an image sensor <NUM> with a diagonal dimension DD carried by the distal sleeve section <NUM> and a working channel <NUM> having a diameter WCD extending through the elongated shaft <NUM>, wherein the working channel portion <NUM>' in the distal end of the shaft <NUM> is adjustable in shape to accommodate a tool <NUM> introduced therethrough and wherein the combination or the sensor's diagonal dimension DD and the working channel diameter WCD is greater than the shaft diameter SD (see <FIG>).

In a variation, the sensor diagonal dimension DD is greater than <NUM>% of the shaft diameter SD or greater than <NUM>% of the shaft diameter. In a variation, the working channel diameter WCD is greater than <NUM>% of the shaft diameter, greater than <NUM>% of the shaft diameter or greater than <NUM>% of the shaft diameter. In other words, the working channel portion <NUM>' in the distal end is adjustable between a first cross-sectional dimension and a second cross-section dimension. In the variation of <FIG>, the working channel portion <NUM>' in the distal region of the endoscope shaft <NUM> is adjustable between a partially constricted shape and a non-constricted shape.

In one variation, referring to <FIG>, the distal tip section <NUM> of the endoscope shaft <NUM> has an axial dimension D1 ranging from <NUM> to <NUM>. Also referring to <FIG>, the angled transition sleeve section <NUM> extends over a similar axial dimension D2 ranging from <NUM> to <NUM>. Still referring to <FIG>, the central axis <NUM> of distal tip section <NUM> can be parallel to and offset from the longitudinal axis <NUM> of the straight shaft section <NUM> by a distance ranging from <NUM> to <NUM>.

Now turning to <FIG>, the image sensor <NUM> is carried in a sensor housing <NUM> that also carries a lens assembly <NUM> as is known in the art. In one variation, the housing <NUM> also carries one or more light emitters, in the variation shown in <FIG>, two LEDs indicated at <NUM> are shown carried in opposing sides of the sensor housing <NUM>. Of particular interest, the distalmost surface <NUM> of the lens assembly <NUM> and the LEDs <NUM> are disposed distally outward from the distal surface <NUM> of distal tip section <NUM> as shown in <FIG>. It has been found that providing such a distalmost surface <NUM> of the lens assembly and the LEDs outwardly from the distal surface <NUM> of distal tip section <NUM> improves lighting from the LEDs <NUM> as well as improving the field of view of the image sensor <NUM>. The distance indicated at D3 in <FIG> can range from <NUM> to <NUM>.

Now referring to <FIG>, another aspect of the invention comprises an optional dedicated fluid pressure sensing channel <NUM> that extends through a thin wall sleeve (not shown) in the endoscope shaft <NUM>. As can be seen in <FIG>, the distal end of the pressure sensing channel <NUM> is open in the distal surface <NUM> of the endoscope shaft <NUM>. The pressure sensing channel <NUM> can extend to disposable pressure sensor in the handle housing <NUM> (not shown) Such a disposable pressure sensor then can have electrical leads coupled through the electrical connector 190A in the handle housing <NUM> thereby send electrical signals indicating pressure to the controller 110A (<FIG>). Thus, in one aspect, the disposable endoscope component <NUM> carries a single-use pressure sensor coupled by a detachable connector to a remote controller 110A.

In one variation of a pressure sensing mechanism, referring to <FIG>, the wall of the pressure sensing channel <NUM> consist of a hydrophobic material, which can be any suitable polymer such as PFTE, having an interior diameter ranging from <NUM> to <NUM>. Often, the diameter of channel <NUM> is between <NUM> and <NUM>. It has been found that a hydrophobic surface in a pressure sensing channel <NUM> will prevent the migration of fluid into the channel and thereby trap an air column in the channel communicating with the pressure sensor. The compressibility of the air column in the pressure sensing channel <NUM> is not significantly affect the sensed pressure since the channel diameter is very small. In another variation, a metal sleeve can be coated with a hydrophobic surface or an ultrahydrophobic surface.

Now referring to <FIG>, <FIG> and <FIG>, it can be seen that the handle component <NUM> has an angled pistol grip portion <NUM> with an axis <NUM> that is angled from <NUM>° to <NUM>° away from the axis <NUM> of the endoscope shaft <NUM>. The grip portion <NUM> includes a finger or thumb-actuated control pad <NUM> that carries actuator buttons for operating all the functions of the treatment system, for example, including (i) operating the fluid management system <NUM>, (ii) capturing images or videos from sensor <NUM>, (iii) adjusting light intensity from the LEDs <NUM>, etc. As described above, the control unit <NUM> typically carries the image processor 110B. However, the interior of the handle component <NUM> also could carry the image processor 110B or a processing component thereof.

<FIG> illustrated the handle component <NUM> and endoscope component <NUM> from a different angle where it can be seen that the grip portion <NUM> has a recessed channel <NUM> therein that is adapted to receive and lock in place the inflow and outflow tubing, 200A and 200B, so as to integrate the tubing set with the pistol grip <NUM> during use. This feature is important so that the inflow and outflow tubing will not interfere with operation of the endoscope component <NUM> or a tool introduced through the working channel <NUM>. The pistol grip <NUM> can have a single recessed channel <NUM> to receive both the inflow and outflow tubing or two recessed channels for separately receiving the inflow tubing and the outflow tubing.

Now turning to <FIG>, the enlarged view of the assembled handle component <NUM> and endoscope component <NUM> shows the control pad <NUM> with four actuator buttons or switches which are adapted to operate the system. In one variation, actuator <NUM> is adapted for turning on and off irrigation, or in other words actuating the fluid management system <NUM> to provide fluid inflow and fluid outflows. Actuator <NUM> is adapted for image or video capture. In a variation, momentary pressing the actuator <NUM> will capture a single image and longer pressure on the actuator will operate a video recording.

The actuator or scrolling button <NUM> has a scrolling function, wherein pressing the scrolling button <NUM> will cycle through various subsystems, wherein each subsystem then can be further adjusted by the central button or up/down actuator <NUM>, which is adapted for increasing, decreasing or otherwise changing an operating parameter of any selected subsystem. In one example, the scrolling button <NUM> can be actuated to cycle through the following subsystems and features: (i) fluid inflow/outflow rate from the fluid management system <NUM>; (ii) the set pressure which is to be maintained by fluid management system <NUM>; (iii) fluid deficit alarm which is calculated by the fluid management system <NUM>; (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 up/down actuator <NUM> to adjust an operating parameter of the selected subsystem. As will be described further below, the selection of subsystems as well as the real-time operating parameters of each subsystem will be displayed on a video monitor or display <NUM> as shown in <FIG>. Thus, it can be understood that the physician may operate the scrolling button <NUM> to scroll through and select any subsystem or feature while observing such as selection on the display <NUM>, and then actuate the up/down actuator <NUM> to adjust an operating parameter which also can be observed on the display <NUM>.

In another aspect of the invention, the controller 110A includes a control algorithm for operating the control pad <NUM> which provides a jump back to a default condition after the scroll button or actuator <NUM> has been used by the physician. For example, the default condition will be a selected default subsystem which is actuatable by the central up/down actuator <NUM>. 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 fluid flow into and out of a working space. As described above, the physician may use the scrolling button <NUM> to select any subsystem for adjustment of an operating parameter. If, however, the physician does not continue to scroll between the various subsystems or change a parameter within a predetermined time interval, then 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 from <NUM> second to <NUM> seconds, more often between <NUM> seconds and <NUM> seconds.

Still referring to <FIG>, the assembly of the handle component <NUM> with endoscope component <NUM> is shown with a plane P to illustrate the sterile field <NUM> and the non-sterile field <NUM> relative to the endoscope assembly. As can be understood, the disposable endoscope component <NUM> is sterilized and the physician or nurse would remove the component <NUM> from sterile packaging which would then define a sterile field <NUM>. The endoscope component <NUM> then would be mated with the handle component <NUM> which defines the non-sterile field <NUM>. In other variations (not shown), a plastic film or other plastic housing could cover the handle portion <NUM>.

A method of the invention can also be understood from <FIG>. It can be understood that the physician must insert the tool <NUM> into the working channel <NUM> in a manner that would insure the sterility of the tool. As can be seen in <FIG>, the grip <NUM> which is sterile has a large diameter recess R therein which tapers into the proximal port <NUM> of the working channel <NUM>. In one variation, the diameter of the recess R is at least <NUM> and often greater than <NUM>. The depth of the recess can range from <NUM> to <NUM> or more. Thus, it can be understood that the physician can easily insert the distal end <NUM> of a tool <NUM> into the mouth of the large diameter recess R without any risk of contacting the non-sterile handle portion <NUM>. Thereafter, the physician can move the tool distal end <NUM> distally over the surface <NUM> of the recess R and into and through the port <NUM> of the working channel <NUM>. By using this method, the physician can be assured that the tool <NUM> will not contact the non-sterile field <NUM>.

Now turning to <FIG>, another aspect of the invention is shown which relates to electronic mechanisms carried by the endoscope <NUM> for re-orienting the image on the display in response to rotation of the endoscope shaft <NUM> to ultimately provide an image-upright configuration on the display. In one variation, an accelerometer <NUM> (which can comprise an accelerometer gyroscope combination) is provided which can send signals to a controller and image processor related to rotation of the endoscope shaft <NUM>. For example, an STmicro IIS2DH <NUM>-axis accelerometer can be used or a <NUM>-axis IMU (Inertial Motion Unit) with <NUM> accelerometer and <NUM> gyroscope axis such as an STmicro ISM330DLC can be used.

The image processor in the controller then can use the accelerometer signals to calculate a necessary amount of rotational correction for the image re-orientation. The calculation includes the degree of rotation of the shaft <NUM> relative to the longitudinal axis <NUM> of the shaft <NUM>. The image is then electronically rotated to display on any video display or monitor can be carried by the handle of the device or most often is a remote display. Thus, the video image on the display can at all times be in an image-upright configuration for viewing by the physician.

As can be seen in <FIG>, the accelerometer <NUM> is carried on the proximal spool <NUM> which is rotatable within the handle assembly <NUM>. Thus, any rotation of the rotating component <NUM> independent of the handle <NUM> or rotation of the handle <NUM> relative to the longitudinal axis <NUM> of the shaft will be sensed by the accelerometer <NUM> to thus allow reorientation of the image on the display. In the variation of <FIG>, a second accelerometer <NUM> is carried on the circuit board <NUM> which is fixed in the non-rotating handle <NUM>. Thus, signals from this accelerometer <NUM> provide signals of rotation of the handle only. In one variation, signals from both accelerometers <NUM>, <NUM> can be compared to determine rotation of the rotating component relative to the handle <NUM>. In one aspect, signals from the second accelerometer <NUM> can be used if signals from the first accelerometer <NUM> fail for any reason. An alert on the display can indicate to the user if either the first or second accelerometer has failed to perform properly.

<FIG> and <FIG> illustrate another variation of an endoscope working end <NUM> which is similar to the previous embodiment. The thin-wall outer sleeve <NUM> is in phantom view in <FIG> and the thin-wall working channel sleeve <NUM> is shown. As described previously, electronic signals from the image sensor <NUM> (<FIG>) as well as power for the image sensor and LEDs 558A and 558B are carried in a flex circuit <NUM> extending through the shaft <NUM> of the endoscope. Since the endoscope shaft <NUM> will be operating in a fluid environment, it has been found that significant RF shielding is needed around the signal-carrying electrical conductors in the flex circuit <NUM> to ensure that potential electrical devices introduced through the working channel <NUM> will not generate electrical fields that may interfere with signals carried in the flex circuit <NUM>.

Thus, in one variation shown in <FIG>, the flex circuit may be an edge-coupled stripline design where two outer dielectric layers 562a and 562b carry electrical conductors <NUM> (including ground planes) and are configured to function as a shield relative to the electric conductors <NUM> disposed in a middle layer <NUM> between the two outer layers 562a and 562b. In this variation, the plurality of electric conductors <NUM> disposed in the middle layer <NUM> are adapted to carry all the signals from the image sensor <NUM>. Thus, the two outer layers 562a and 562b function as a shield to prevent any potential interference from electrical tools that might interfere with the signals carried by the interior conductors <NUM> in the middle layer <NUM>.

In one variation, the signal carrying conductors <NUM> in the middle layer <NUM> are provided with a dielectric insulator layer on both sides that has a thickness of at least <NUM>", at least <NUM>" or at least <NUM>". The insulator layers can be any suitable power material such Kapton.

In some variations, the number of electrical conductors <NUM> that carry image signals in the middle layer <NUM> can vary from <NUM> to <NUM> or more and typically range from <NUM> to <NUM> conductors. In this variation, the electrical leads to the LEDs 558A and 558B are also carried in the middle layer <NUM> which could be subject to interference from electrical tool. Thus, providing the electrical leads and signal conductors in the middle layer <NUM> in the stripline design allows for an overall flex circuit <NUM> that is thinner and more flexible than other configurations that provide adequate RF shielding.

Now turning to <FIG>, the endoscope shaft working end <NUM> is similar to that of <FIG>. In the variation of <FIG>, the shaft working <NUM> end has a secondary flexible hinge portion <NUM> which allows for changing the angle of the field of view FOV of the image sensor <NUM> about its axis <NUM>. For introduction into a working site in the patient's body, the working end <NUM> of the shaft <NUM> has a distal segment <NUM> that has an axis <NUM> that is angled relative to the longitudinal axis <NUM> of the shaft <NUM> at a selected angle which can be from <NUM>° to <NUM>°. It can be seen in <FIG> that a second or intermediate segment <NUM> of the working end <NUM> includes a living hinge portion <NUM> which allows it to flex relative to the proximal shaft segment <NUM>. The intermediate segment <NUM> and distal segment <NUM> are fixed together at an angle which can be seen in <FIG> and <FIG>. The mechanism for actuating the distal segment <NUM> and intermediate segment <NUM> to a flexed position (see <FIG>) consists of inserting an elongated tool body or shaft <NUM> through the working channel <NUM> as described previously.

<FIG> are schematic transparent views of the working end <NUM> of <FIG> showing the interior working channel <NUM> and the proximal shaft segment <NUM>, the intermediate shaft segment <NUM> and the distal shaft segment <NUM>. In <FIG>, it can be seen that the elongated tool body <NUM> (phantom view) has been inserted through the working channel <NUM> which causes multiple effects. First, as described previously, the elongated tool shaft <NUM> stretches the resilient silicone sleeve <NUM> around the working end <NUM> (<FIG>) to expand the working channel <NUM> from a collapsed condition to an expanded condition. At the same time, the introduction of the tool shaft <NUM> through the working channel <NUM> flexes the proximal hinge <NUM> at the proximal end of the intermediate segment <NUM> to cause the intermediate and distal segments <NUM> and <NUM> to flex away from the repose position (<FIG>) to a tensioned position (<FIG>) wherein the axis <NUM> of the image sensor <NUM> is parallel to the longitudinal axis <NUM> of the proximal shaft portion <NUM>. In this flexed position of <FIG>, the image sensor <NUM> then is aligned with the longitudinal axis <NUM> of the shaft and the sensor axis <NUM> and the angle of the field of view FOV then can be <NUM>° relative to the longitudinal axis <NUM> of the shaft.

In this variation shown in <FIG>, it can be seen that the tensioning support sleeve <NUM> is shown which partially surrounds the proximal endoscope shaft portion <NUM> and sleeve segment <NUM>. More in particular, the support sleeve <NUM> has an upper surface <NUM> that is fixed to the adjacent upper surface <NUM> of the proximal shaft portion <NUM>. The support sleeve <NUM> has a longitudinal discontinuity <NUM> therein and the sleeve extends around the shaft from about <NUM>° to <NUM>°. It can further be seen in <FIG> that the support sleeve with a length LL which extends over a portion of the proximal shaft <NUM> and over a portion of the intermediate sleeve <NUM>. As can be seen in <FIG> and <FIG>, the interior portion of the support sleeve <NUM> has the longitudinal gap or discontinuity <NUM> which allows the side portions 640a and 640b to be flexed outwardly when an elongated tool shaft <NUM> is introduced through the working channel <NUM>. In this aspect, the support sleeve <NUM> functions as a spring which urges the side portions 640a and 640b radially inwardly to return the endoscope shaft <NUM> to a straight configuration when the tool shaft <NUM> is removed from the working channel <NUM>.

In another aspect of the invention referring to the exploded view of <FIG>, it can be seen that the distal end of the distal shaft segment <NUM> includes a housing <NUM> that carries both the image sensor <NUM> and first and second LEDs 558A and 558B. The housing <NUM> can be molded out of any suitable polymer and includes means for providing flex circuit connections to both the image sensor <NUM> and the LEDs. An upper guide surface <NUM> is coupled to the sensor housing <NUM> to provide a sliding interface against which the tool shaft <NUM> can push and deflect the distal segment <NUM> and sensor housing <NUM>. A lower guide surface <NUM> is coupled by a flexible element <NUM> to the working channel sleeve <NUM> to provide a sliding interface against which the tool shaft <NUM> can open the working channel <NUM> without contacting the silicone sleeve <NUM> (see <FIG>).

Although particular embodiments of the present invention have been described above in detail, it will be understood that this description is merely for purposes of illustration and the above description of the invention is not exhaustive. Specific features of the invention are shown in some drawings and not in others, and this is for convenience only and any feature may be combined with another in accordance with the invention. A number of variations and alternatives will be apparent to one having ordinary skills in the art. Such alternatives and variations are intended to be included within the scope of the claims. Particular features that are presented in dependent claims can be combined and fall within the scope of the invention. The invention also encompasses embodiments as if dependent claims were alternatively written in a multiple dependent claim format with reference to other independent claims.

While the invention is susceptible to various modifications and alternative constructions, certain illustrated embodiments thereof are shown in the drawings and have been described above in detail. It should be understood, however, that there is no intention to limit the invention to the specific form or forms disclosed, but on the contrary, the intention is to cover all modifications, alternative constructions, and equivalents falling within the scope of the invention, as defined in the appended claims.

Claim 1:
An endoscope electrically coupled to an image display and configured for use with an elongated tool (<NUM>), the endoscope comprising:
an elongated shaft (<NUM>) having a shaft assembly (<NUM>) located at a proximal end of the elongated shaft (<NUM>), an image sensor (<NUM>; <NUM>) and a lens facing distally at a distal end of the elongated shaft (<NUM>);
a handle (<NUM>) coupled to the shaft assembly (<NUM>), where the shaft assembly (<NUM>) is rotatable in the handle (<NUM>);
a working channel (<NUM>; <NUM>) within the elongated shaft and extending to a distal segment adjacent to the distal end of the elongated shaft (<NUM>), wherein advancing the elongated tool out of the working channel causes the side portions of the elongated shaft at the distal segment to flex outwardly;
a first accelerometer (<NUM>) coupled to the elongated shaft (<NUM>) such that rotation of the elongated shaft (<NUM>) rotates the first accelerometer (<NUM>);
wherein the first accelerometer (<NUM>) is configured to provide signals to determine rotation of the image sensor (<NUM>; <NUM>) relative to a longitudinal axis of the elongated shaft (<NUM>), wherein the signals permit rotation of an image on the image display;
a support sleeve (<NUM>) located about a portion of the distal segment, wherein the support sleeve (<NUM>) urges the side portions of the elongated shaft inward upon removal of the elongated tool (<NUM>); and
a lower guide surface (<NUM>) coupled by a flexible element to a working channel sleeve to provide a sliding interface against which the elongated tool (<NUM>)can advance through the distal segment without contacting the support sleeve (<NUM>).