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 re-usable 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>.

<CIT> describes 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 hysteroscopic device comprises a rotatable shaft and slack compensation for the electrical leads between the image capturing structure and a proximal connector in the handle. The elongated member and the image capturing structure are dimensioned for insertion into the patient's uterus through the cervix. <CIT> describes an endoscope having a shaft extending along a longitudinal axis to a distal housing. An image sensor is carried by the distal housing and a channel extends through the shaft and distal housing. A distal portion of the channel is adjustable or curved to accommodate the introduction of a tool while maintaining a reduced shaft diameter. A diagonal dimension of the image sensor when combined with the channel diameter is greater than a shaft diameter. The distal housing may be flexible to accommodate passage of a straight tool through a curved distal portion of a working channel.

In a first aspect of the present disclosure, 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 disclosure will be found in endoscopes comprising fixed handle-shaft structures as well.

In certain exemplary embodiments of the endoscopes of the present disclosure, the diagonal dimension will be at least <NUM>% of the outer shaft diameter, typically being at least <NUM>%, or greater. In further exemplentary 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 disclosure 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 comprises 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 disclosure, 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 still further aspects of this endoscope, a channel may be 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 disclosure, 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 disclosure, 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 disclosure, 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.

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

<FIG> illustrates a hysteroscopic treatment system <NUM> 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 re-usable 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 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 disclosure, 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 disclosure, 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>).

<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 disclosure 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 shapes 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 disclosure 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 parallel to and offset from the longitudinal axis <NUM> of the straight shaft section <NUM> by a distance ranging 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.

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 disclosure, 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 disclosure 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>.

Although particular embodiments have been described above in detail, it will be understood that this description is merely for purposes of illustration and the above description is not exhaustive. Specific features 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 claimed 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 claimed 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.

Other variations are within the scope of the claimed invention. Thus, while the claimed 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 claimed 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 appended claims.

The use of the terms "a" and "an" and "the" and similar referents in the context of describing the disclosure (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The term "connected" is to be construed as partly or wholly contained within, attached to, or joined together, even if there is something intervening. The use of any and all examples, or exemplary language (e.g., "such as") provided herein, is intended merely to better illuminate embodiments does not pose a limitation on the scope of the claimed invention unless otherwise claimed.

Claim 1:
An endoscope comprising:
a shaft (<NUM>) having an outer shaft diameter, a distal shaft portion, a proximal shaft portion, and a longitudinal axis therebetween, wherein the shaft is configured to rotate at least about <NUM>° about the axis;
a handle (<NUM>) coupled to the proximal portion of the shaft (<NUM>);
an electrical connector fixed to the handle (<NUM>)
an electronic image sensor with a diagonal dimension carried by the distal portion of the shaft (<NUM>);
electrical leads extending from the image sensor to the connector fixed in the handle (<NUM>), wherein the electrical leads are flexible and configured with a slack portion in the interior of the handle (<NUM>) to accommodate rotation of the shaft (<NUM>); and
a channel (<NUM>) extending through at least the distal shaft portion and having a channel diameter,
wherein a section of the channel (<NUM>) in the distal portion is re-configurable between a constricted shape and a non-constricted shape to accommodate a tool introduced therethrough and wherein the combined diagonal dimension and channel diameter is greater than the outer shaft diameter,
wherein one end of the slack portion extends around the longitudinal axis of the rotating shaft and is carried on a spool (<NUM>) and the spool (<NUM>) is concentric with the longitudinal axis of the shaft.