Patent Description:
The present disclosure is directed generally to steering handles for flexible catheters and more specifically to steering handles for laser lithotripsy ureteroscopes having multiple channel manifolds.

Kidney stones affect <NUM> in <NUM> Americans each year, causing significant pain and healthcare expense. Surgical options for patients with symptomatic kidney stones include extracorporeal shock wave lithotripsy (ESWL), ureteroscopy, and percutaneous nephrolithotomy (PCNL). A person's renal anatomy, stone composition, and body habitus all play major roles in determining outcomes and operative approach.

The role of ureteroscopy over the last ten years has improved due to reductions in the diameter of the flexible catheter shaft, enhanced steering and deflection capabilities, video-imaging, miniaturization of baskets and instruments, and advances in lithotripsy (stone breakage) with the advent of Holmium (Ho):YAG, Thulium (Tm):YAG, and Thulium fiber lasers. Over <NUM>% of all kidney stone surgeries are now done using small ureteroscope technology and a laser.

Ureteroscopy involves the use of a small flexible or rigid device called a ureteroscope to directly see and treat stones. The ureteroscope device, which provides a video image and has small "working" channels, is inserted into the bladder and up the ureter until the stone is encountered. The stone can then either be broken up with laser energy that is transmitted via a fiber optic to the target site, or pulled out using small baskets that are inserted into the working channels. The advantage of this type of surgery is that body orifices are used for access, requiring no incisions.

Ureteroscopy is often a good option for small stones in the ureter or kidney. Success rates for ureteroscopy for clearing these types of stones is generally higher than that for shockwave lithotripsy. However, compared with shockwave lithotripsy, ureteroscopy is sometimes associated with increased discomfort after surgery.

The discomfort associated with laser lithotripsy correlates with the time the ureteroscope occupies the body of the patient. A laser endoscopic system that enables reduced procedural times would be welcomed.

<CIT> discloses an endoscopic surgical instrument for denervation, such as renal denervation and the like, comprising an optical fiber situated within a cannula and defining therebetween a channel which can deliver a sterile, biocompatible liquid. The instrument provides a suction channel as a working channel.

<CIT> discloses a multiple purpose medical forceps allowing for simultaneous grasping of tissue during surgery. The forceps includes a laser fiber and irrigation and suction catheters contained within a tubular housing and exiting adjacent a pair of jaws. The forceps is insertable through a cannula into a patient's body cavity where scopic surgery may be performed.

The present invention is defined by the accompanied independent claims. Advantageous embodiments can be found in the dependent claims.

Various embodiments of the disclosure include a steering handle with a manifold that enables an operator to configure an endoscopic system in situ for a variety of tasks, including irrigation and aspiration.

In addition, the disclosed endoscopic systems facilitate rapid reconfiguration of the location of a laser fiber optic within a catheter assembly. That is, the laser fiber optic, for example, can be removed from an irrigation channel of the endoscopic system and reinserted in the aspiration channel during a laser lithotripsy procedure. In some embodiments, the removal and reinsertion can be performed in situ, without removing the catheter from the patient or the treated organ. In some embodiments, multiple working devices can be used simultaneously via multiple working channels. These aspects of the disclosed system reduce the time required to perform laser lithotripsy procedures, with less trauma to the patient.

In some embodiments, the manifold can be configured to divert irrigation from a first or main working channel to a second or auxiliary working channel. Likewise, certain embodiments enable diverting aspiration from one working channel to the other working channel. In addition, some embodiments enable configuring both working channels to be configured for either an "irrigation-only" or an "aspiration only" operating mode. The ability to reconfigure the endoscopic surgical system in these ways enables an operator to make flow and/or aspiration adjustments in-situ. For example, if a working device is disposed in a working channel that is utilized for irrigation, there may be instances where the working device obstructs the working channel to the point that irrigation is insufficient. The ability to divert the irrigation from the occupied working channel to the unoccupied working channel (or to irrigate with both working channels) enables the operator to remedy the insufficient irrigation condition, for example temporarily, to enable the irrigation to "catch up" with the aspiration. Similarly, for instances where a working device is disposed in a working channel that is utilized for aspiration and obstructs the working channel to the point that aspiration is insufficient, some embodiments enable the manifold to be configured in an "aspiration-only" configuration to enable the aspiration to catch up with the irrigation. The ability to maintain balanced irrigation and aspiration flows over time
increases stone-free-rates of endoscopic procedures (i.e., the percentage of patients remaining stone free at certain time point benchmarks after the procedure).

The above-mentioned aspects are provided in a compact manifold that can be disposed within a catheter steering handle, and may therefore be available literally in the palm of the operator's hand. As such, the disclosed system provides quick and easily implemented remedy to situations as they develop, which may be acted on autonomously by the operator, and without need for time consuming reconfiguration of the irrigation source and/or aspiration source hook ups, while leaving the catheter in place.

Structurally, various embodiments of the disclosure depict and describe an endoscopic surgical system, comprising a catheter shaft defining a central axis that extends from a proximal end portion through a distal end portion of the catheter shaft, the catheter shaft including a main working channel that extends parallel to the central axis and an auxiliary working channel that extends parallel to the central axis, and a steering handle including a manifold that includes an main working channel output port in fluid communication with the main working channel and an auxiliary working channel output port in fluid communication with the auxiliary working channel, the manifold configured to accept a fiber optic for selective routing through the main working channel via the main working channel output port and the auxiliary working channel via the auxiliary working channel output port. In some embodiments, the manifold includes a main working channel input port for passage of the fiber optic through the main working channel via the main working channel output port. The manifold may also include a second fiber optic input port for passage of the fiber optic through the auxiliary working channel via the auxiliary working channel output port. In some embodiments, the catheter shaft is flexible. The laser fiber optic may be factory installed. In some embodiments, one of the main working channel and the auxiliary working channel permanently houses the laser fiber optic. A fiber optic may be disposed in one of the main working channel and the auxiliary working channel via the manifold. In some embodiments, a laser system is operatively coupled to the fiber optic. The laser system may be an ablation laser system and include one of a Holium:YAG laser, a Thulium fiber laser, a Thulium:YLF laser, and a Thulium:YAG laser.

In some embodiments, the manifold includes an irrigation input port and an aspiration input port, the manifold being configured to selectively isolate the auxiliary working channel from the irrigation input port and the aspiration input port. The manifold may be configured to selectively isolate the main working channel from the irrigation input port. The endoscopic surgical instrument may also include an irrigation source in fluid communication with the irrigation input port, and an aspiration source in fluid communication with the aspiration input port.

In various embodiments of the disclosure, an endoscopic surgical instrument is disclosed that comprises a steering handle including a housing containing a manifold, the manifold including an irrigation input port, an auxiliary working channel input port, a main working channel input port, a main working channel output port, and an auxiliary working channel output port, wherein the manifold includes one or more valves for selectively isolating the irrigation input port from the main working channel output port and the auxiliary working channel output port. In some embodiments, the manifold includes a plurality of valves for selectively establishing fluid communication between the irrigation input port and the main working channel output port, and between the irrigation input port and the auxiliary working channel output port. In some embodiments, the plurality of valves are configurable for selectively establishing fluid communication between the main working channel input port and the main working channel output port, and between the auxiliary working channel input port and the auxiliary working channel output port. In some embodiments, the irrigation input port is selectively isolated from the main working channel output port by a first of the plurality of valves, and the irrigation input port is selectively isolated from the auxiliary working channel output port by a second of the plurality of valves.

In some embodiments, a main working channel circuit includes the main working channel input port and the main working channel output port, the main working channel circuit being configured to pass a fiber optic therethrough. The main working channel circuit may include a third of the plurality of valves to selectively isolate the main working channel input port from the main working channel output port. In some embodiments, the main working channel circuit includes a compression fitting proximate the main working channel input port. In some embodiments, an auxiliary working channel circuit includes the auxiliary working channel input port and the auxiliary working channel output port, the auxiliary working channel circuit being configured to pass a working device therethrough. The auxiliary working channel circuit may be configured to pass any one of a fiber optic, a basket, a guide wire, and a biopsy forceps as the working device. In some embodiments, the auxiliary working channel circuit includes a third of the plurality of valves to selectively isolate the auxiliary working channel input port from the auxiliary working channel output port. The auxiliary working channel circuit may include a compression fitting proximate the auxiliary working channel input port, for example a TUOHY BORST adaptor. In some embodiments, the manifold includes an aspiration input port, and the auxiliary working channel input port and the aspiration input port are selectively isolated from the auxiliary working channel output port by the third of the plurality of valves.

In some embodiments, the first of the plurality of valves, the second of the plurality of valves, and the third of the plurality of valves are multiple-position valves that are coupled to and selectively positioned by a multiple-position selector switch. The multiple-position selector switch may include a stem that rotates about a stem axis and connects the multiple-position valves to the multiple-position selector switch, each of the multiple-position valves being rotatable about the stem axis. In some embodiments, the multiple-position selector switch is a three-position selector switch, and the multiple-position valves are three-position valves.

The manifold may include an aspiration input port in fluid communication with the auxiliary working channel output port, where a fourth of the plurality of valves selectively isolates the aspiration input port from the auxiliary working channel output port. In some embodiments, each of the plurality valves includes a stem and a manual actuator that extends through the housing.

In some embodiments of the disclosure, a flexible catheter shaft includes a proximal end portion and a distal end portion and defining a central axis that extends from the proximal end portion to the distal end portion, the flexible catheter shaft defining a main working channel that extends parallel to the central axis and an auxiliary working channel that extends parallel to the central axis, the auxiliary working channel output port of the manifold being in fluid communication with the auxiliary working channel, the main working channel output port of the manifold being in fluid communication with the main working channel. The main working channel may extend through a distal face of the distal end portion of the flexible catheter shaft.

Various embodiments of the disclosure present a method for changing the location of a laser fiber optic at a distal end of a catheter, comprising providing a steering handle operatively coupled to a flexible catheter and providing instructions for use on a tangible, non-transitory medium. The instructions include: removing a laser fiber optic from a first fluid circuit of the steering handle and the flexible catheter, the first fluid circuit extending through a distal end of the flexible catheter; and inserting the laser fiber optic into a second fluid circuit of the steering handle and the flexible catheter, the second fluid circuit extending through the distal end of the flexible catheter, wherein the first fluid circuit is separate and distinct from the second fluid circuit. In some embodiments, the instructions include: releasing the laser fiber optic from a first compression fitting of the first fluid circuit before the step of removing; and sealing the fiber laser with a second compression fitting of the second fluid circuit after the step of inserting. The instructions may also include placing the distal end of the flexible catheter in a bodily organ before the steps of removing and inserting; and leaving the distal end of the flexible catheter within the bodily organ during the steps of removing and inserting. In some embodiments, isolating one or both of the first fluid circuit and the second fluid circuit from an irrigation source after the step of placing and before the steps of removing and inserting. The instructions may also include isolating one or both of the first fluid circuit and the second fluid circuit from an aspiration source after the step of placing and before the steps of removing and inserting. The bodily organ may be one of a bladder, a ureter, and a kidney.

In various embodiments of the disclosure, a method for changing a direction of flow through at least one lumen of a catheter comprises providing a steering handle including a manifold mounted thereto, the manifold being operatively coupled to a catheter, and providing instructions for use on a tangible, non-transitory medium, the instructions including: closing a first valve of the manifold to isolate a first lumen of the catheter from one of an aspiration source and an irrigation source, the first valve being accessible on the steering handle; and opening a second valve of the manifold to fluidly connect the first lumen of the catheter to an other of the aspiration source and the irrigation source, the second valve being accessible on the steering handle. In some embodiments, opening the second valve isolates the irrigation source from a second lumen of the catheter. In some embodiments, the first valve and the second valve are actuated with a single selector switch accessible on the steering handle.

The instructions may further include removing a working device from the first lumen via a working device input port of the manifold, the working device input port being in fluid communication with the first lumen and accessible on the steering handle. The instructions may include sealing the working device input port after the step of removing the working device from the first lumen. In some embodiments, the instructions include isolating the working device input port from the first lumen with a third valve of the manifold, the third valve being accessible on the steering handle.

In some embodiments, the instructions include fluidly connecting the first lumen and a working device input port of the manifold and with a third valve of the manifold, the third valve being accessible on the steering handle. The instructions may include inserting a working device into the first lumen via the working device input port, the working device input port being in fluid communication with the first lumen and accessible on the steering handle. In some embodiments, the instructions include sealing the working device input port about the working device after the step of inserting the working device into the first lumen. The instructions may include connecting an aspiration source to a working channel input port of the manifold of the steering handle, the working channel input port being in fluid communication with the first channel.

In various embodiments of the disclosure, a method for selectively increasing irrigation flow through a catheter comprises providing a steering handle including a manifold mounted thereto, the manifold being operatively coupled to a catheter, and providing instructions for use on a tangible, non-transitory medium, the instructions including: coupling an irrigation source to an irrigation port of the manifold, the irrigation port being accessible on the steering handle; establishing an irrigation flow through a first lumen of the catheter from the irrigation source through the irrigation port; and opening a valve of the manifold to establish fluid communication between a second lumen of the catheter and the irrigation port, the second valve being accessible on the steering handle.

Referring to <FIG>, a schematic of an endoscopic system <NUM> for laser lithotripsy is depicted according to an embodiment of the disclosure. The endoscopic system <NUM> includes a steering handle <NUM> coupled to a catheter <NUM> and to a variety of external systems <NUM>. The steering handle <NUM> includes a manifold <NUM> configured to connect to at least some of the external systems <NUM>. In some embodiments, the manifold <NUM> variously receives inputs from and/or sends outputs to an irrigation system <NUM>, a suction or aspiration system <NUM>, and a laser system <NUM> (e.g., an ablation laser system). The laser system may include, for example, Holium:YAG laser source, a Thulium fiber laser source, a Thulium:YLF laser source, or a Thulium:YAG laser source. Other external systems <NUM> may be routed through the steering handle <NUM> as well, but not necessarily routed through the manifold <NUM> (e.g., a light system <NUM> and an imaging system <NUM>, depicted). The catheter <NUM> includes a catheter shaft <NUM> defining a central or catheter axis <NUM> that extends from a proximal end portion <NUM> through a distal end portion <NUM> of the catheter shaft <NUM>. In some embodiments, the catheter <NUM> includes a distal head portion <NUM> coupled to the distal end portion <NUM> of the catheter shaft <NUM>. In some embodiments, the catheter <NUM> and the catheter shaft <NUM> are flexible (depicted).

Referring to <FIG>, a schematic <NUM> of a manifold 48a operatively coupled to the irrigation system <NUM>, the aspiration system <NUM>, the laser system <NUM>, and the proximal end portion <NUM> of the catheter shaft <NUM> and catheter <NUM> is depicted according to an embodiment of the disclosure. Herein, manifolds are referred to generically or collectively as with reference character <NUM>, and individually or specifically with the reference character <NUM> followed by a letter suffix (e.g., "manifold 48a"). The manifold 48a includes a plurality of input ports <NUM> that are in fluid communication with a plurality of output ports <NUM> via a plurality of conduits <NUM>. A plurality of isolation valves <NUM> are operatively coupled to the plurality of conduits <NUM> of the manifold 48a. In some embodiments, each of the plurality of isolation valves <NUM> is coupled to a respective one of the plurality of conduits <NUM>. The isolation valves <NUM> may be "two-position" or binary valves that are either "on" (e.g., enabling flow therethrough) or "off' (e.g., isolating or blocking flow therethrough). One or more of the input ports <NUM> may include a compression fitting <NUM>.

In some embodiments, the plurality of input ports <NUM> may include a main working channel input port <NUM>, an irrigation input port <NUM>, and an auxiliary working channel input port <NUM>. The plurality of output ports <NUM> of the manifold 48a includes a main working channel output port <NUM> and an auxiliary working channel output port <NUM>. The main working channel input port <NUM> may be operatively coupled to the ablation laser system <NUM>. The irrigation input port <NUM> may be coupled to the irrigation system <NUM>. The auxiliary working channel input port <NUM> may be coupled to the aspiration system <NUM>. In some embodiments, the auxiliary working channel input port <NUM> accommodates a working device <NUM> as an alternative to the aspiration system <NUM>. Herein, a "working channel" may be configured to accommodate working tools such as, for example, laser fibers and baskets, or be configured to accommodate irrigation or aspiration flows or both, or a combination of all of these.

A plurality of fluid circuits <NUM> are defined by unique combinations of the input ports <NUM>, conduits <NUM>, output ports <NUM>, and catheter lumens <NUM>, the fluid circuits <NUM> being enabled by opening the respective isolation valve <NUM>. For the manifold 48a, the plurality of circuits <NUM> includes a main working channel circuit <NUM>, a first irrigation circuit <NUM>, an auxiliary working channel circuit <NUM>, and a second irrigation circuit <NUM>. The main working channel circuit <NUM> includes the main working channel input port <NUM>, a main working channel conduit 90a, the main working channel output port <NUM>, and a main working channel <NUM>, which are selectively connected through isolation valve 96a. The first irrigation circuit <NUM> includes the irrigation input port <NUM>, a first irrigation conduit 90b, the main working channel output port <NUM>, and the main working channel <NUM>, which are selectively connected through isolation valve 96b. The auxiliary working channel circuit <NUM> includes the auxiliary working channel input port <NUM>, the auxiliary working channel conduit 90d, the auxiliary working channel output port <NUM>, and an auxiliary working channel <NUM>, which are selectively connected through isolation valve 96d. The second irrigation circuit <NUM> includes the irrigation input port <NUM>, a second irrigation conduit 90c, the auxiliary working channel output port <NUM>, and the auxiliary working channel <NUM>, which are selectively connected through isolation valve 96c.

The plurality of fluid circuits <NUM> and isolation valves <NUM> can be manipulated to selectively establish fluid communication between the plurality of input ports <NUM> and the plurality of output ports <NUM>. In some embodiments, the plurality of isolation valves <NUM> are configured to selectively establish fluid communication between the main working channel input port <NUM> and the main working channel output port <NUM>, the irrigation input port <NUM> and the main working channel output port <NUM>, the irrigation input port <NUM> and the auxiliary working channel output port <NUM>, and the auxiliary working channel input port <NUM> and the auxiliary working channel output port <NUM>.

In some embodiments, the plurality of conduits <NUM> include four conduits 90a through 90d, and the plurality of isolation valves <NUM> include a corresponding four isolation valves 96a through 96d. In these embodiments, the main working channel input port <NUM> is selectively isolated from the main working channel output port <NUM> by a first isolation valve 96a of the plurality of isolation valves <NUM>, the irrigation input port <NUM> is selectively isolated from the main working channel output port <NUM> by a second isolation valve 96b of the plurality of isolation valves <NUM>, the irrigation input port <NUM> is selectively isolated from the auxiliary working channel output port <NUM> by a third isolation valve 96c of the plurality of isolation valves <NUM>, and the auxiliary working channel input port <NUM> is selectively isolated from the auxiliary working channel output port <NUM> by a fourth isolation valve 96d of the plurality of isolation valves <NUM>. Alternatively, a single three-position valve (not depicted) may be used instead of the two isolation valves 96b and 96c, the three-position valve putting the irrigation port in fluid communication with either one or both of the main working channel output port <NUM> the auxiliary working channel output port <NUM>.

The catheter <NUM> includes a plurality of lumens <NUM> that extend through the catheter <NUM> and, at least over the length of the catheter shaft <NUM>, are parallel to the central axis <NUM>. The plurality of lumens <NUM> include a main working channel <NUM> and an auxiliary working channel <NUM>, each In some embodiments, the catheter <NUM> defines the main working channel <NUM> and the auxiliary working channel <NUM>. Each of the main working channel <NUM> and the auxiliary working channel <NUM> pass through the distal end portion <NUM> of the catheter shaft <NUM>.

In some embodiments, the fiber optic input port <NUM> is fitted with a first compression fitting <NUM> of the compression fittings <NUM>, the first compression fitting <NUM> being configured to accept a laser fiber optic <NUM> that is operatively coupled to the laser source of the ablation laser system <NUM>. The first compression fitting <NUM> may be mounted between the fiber optic input port <NUM> and the isolation valve 96a (depicted). Alternatively, the isolation valve 96a may be mounted between the fiber optic input port <NUM> and the first compression fitting <NUM>. In some embodiments, the first compression fitting defines the fiber optic input port <NUM>. One or more of the compression fittings <NUM> may be TUOHY BORST adaptors configured for use with one or more working devices <NUM>. In some embodiments, the auxiliary working channel input port <NUM> accommodates alternative configurations, with the auxiliary working channel input port <NUM> being coupled either to the aspiration system <NUM> or to a second compression fitting <NUM> of the compression fittings <NUM>. The second compression fitting <NUM> may be configured one of a variety of working devices <NUM>, such as a basket, a guide wire, or a biopsy forceps (none depicted). The second compression fitting may also be configured to accept the fiber optic <NUM> (depicted) as the working device <NUM>.

In some embodiments, the steering handle <NUM> and catheter <NUM> are pre-assembled or factory installed with the laser fiber optic <NUM> in place. The factory installed fiber optic <NUM> may be removable, as disclosed herein, or may be permanently installed, with one of the working channels <NUM>, <NUM> dedicated to housing the laser fiber optic <NUM>.

Functionally, the steering handle <NUM> integrates various external components or systems <NUM> for control and delivery to the catheter <NUM>. The plurality of isolation valves <NUM> enables the manifold 48a to be configured to selectively isolate the auxiliary working channel <NUM> from the irrigation input port <NUM> and/or the aspiration input port <NUM>, as well as enabling the manifold 48a to be configured to selectively isolate the main working channel <NUM> from the fiber optic input port <NUM> and/or the irrigation input port <NUM>. The compression fittings <NUM> enable passage of the laser fiber optic <NUM> or other working devices <NUM> while prevent irrigation and/or aspiration liquids from leaking around the working device <NUM> during operation. The flexibility of introducing working devices <NUM> other than the laser fiber optic <NUM> enables the endoscopic system <NUM> to be implemented for uses other than ablation therapy. Embodiments that include the option of providing compression fittings <NUM> and <NUM> on both the fiber optic input port <NUM> and the auxiliary working channel input port <NUM> enable the laser fiber optic <NUM> to be selectively configured for accessing a target zone from either the main working channel <NUM> or the auxiliary working channel <NUM> of the catheter <NUM>.

In operation, the plurality of isolation valves <NUM> may be manipulated to define a plurality operating configurations, each representing a unique input and output combination. A tabulation of example valve combinations for manifold 48a is provided in Table <NUM> and described below.

In a first configuration for manifold 48a, isolation valves 96a, 96b, and 96c are opened and isolation valve 96d is closed, with the laser fiber optic <NUM> being inserted through the isolation valve 96a and first compression fitting <NUM>. This first configuration is an "irrigation-only" configuration, enabling irrigation through both the main working channel <NUM> and the auxiliary working channel <NUM>, with the laser fiber optic <NUM> residing in the main working channel <NUM>.

In a second configuration for manifold 48a, isolation valves 96b, 96c, and 96d are opened and isolation valve 96a is closed, with the fiber optic <NUM> being inserted through the isolation valve 96d. In this second configuration, the aspiration system <NUM> is disconnected and the second compression fitting <NUM> may be coupled to the auxiliary working channel input port <NUM>. This second configuration is also an "irrigation-only" configuration, enabling irrigation through both the main working channel <NUM> and the auxiliary working channel <NUM>, but with the laser fiber optic <NUM> residing in the auxiliary working channel <NUM>.

In a third configuration for manifold 48a, isolation valves 96a, 96b, and 96d are opened and isolation valve 96c is closed, with the laser fiber optic <NUM> inserted through the isolation valve 96a and first compression fitting <NUM>. This third configuration is an "irrigation/aspiration" configuration, with both irrigation and aspiration being enabled to the catheter <NUM>, and with the laser fiber optic <NUM> residing in the main working channel <NUM>.

In a fourth configuration for manifold 48a, isolation valves 96a and 96d are opened and isolation valves 96b and 96c are closed. This fourth configuration is an "aspiration only" configuration, with the laser fiber optic <NUM> residing in the main working channel <NUM>.

In a fifth configuration for manifold 48a, the isolation valves 96b and 96c are closed while the position of isolation valves 96a and 96d are variable and unspecified. This fifth configuration is a "transition" configuration wherein the catheter <NUM> and the output ports <NUM> of the manifold are isolated from the irrigation system <NUM> and the aspiration system <NUM>, while the fiber optic input port <NUM> and the auxiliary working channel input port <NUM> may be opened or closed. The transition configuration may be implemented, for example, when switching the fiber optic <NUM> (or other working device <NUM>) from the main working channel circuit <NUM> to the auxiliary working channel circuit <NUM>, or when switching the fiber optic <NUM> (or other working device <NUM>) from the auxiliary working channel circuit <NUM> to the main working channel circuit <NUM>, as described below attendant to <FIG>.

In a sixth configuration for manifold 48a, all the isolation valves 96a through 96d are closed with the laser fiber optic <NUM> withdrawn. This sixth configuration is a "closed" configuration that completely isolates the catheter <NUM> from the irrigation system <NUM>, the aspiration system <NUM>, and the ablation laser system <NUM>.

Referring to <FIG>, a schematic <NUM> of a manifold 48b operatively coupled to the irrigation system <NUM>, the aspiration system <NUM>, the ablation laser system <NUM>, and the proximal end portion <NUM> of the catheter <NUM> is depicted according to an embodiment of the disclosure. The manifold 48b includes many of the same components and attributes as manifold 48a of <FIG>, which are indicated with same-numbered reference characters.

In addition, manifold 48b includes a dedicated aspiration port <NUM> as one of the plurality of input ports <NUM>. In some embodiments, both the auxiliary working channel input port <NUM> and the aspiration port <NUM> access the same conduit <NUM> (i.e., auxiliary working channel conduit 90d). The manifold 48b may also include an isolation valve 96e as one of the plurality of isolation valves <NUM>. The isolation valve 96d may be mounted between the auxiliary working channel input port <NUM> and the second compression fitting <NUM> (depicted). Alternatively, the second compression fitting <NUM> may be mounted between the auxiliary working channel input port <NUM> and the isolation valve 96d. In some embodiments, the second compression fitting <NUM> defines the auxiliary working channel input port <NUM>.

For the manifold 48b, the plurality of fluid circuits <NUM> includes an aspiration circuit <NUM>. The aspiration circuit <NUM> includes the aspiration port <NUM>, the auxiliary working channel conduit 90d, the auxiliary working channel output port <NUM>, and the auxiliary working channel <NUM>, which are selectively connected through isolation valve 96e.

Functionally, the dedicated aspiration port <NUM> enables working devices <NUM> to access the auxiliary working channel <NUM> without forfeiting aspiration. As such, the auxiliary working channel <NUM> can accommodate the working device <NUM> (e.g., laser fiber optic <NUM>) and also serve as an aspiration channel.

In operation, the plurality of isolation valves <NUM> may be manipulated to define a plurality operating configurations, each representing a unique input and output combination. A tabulation of example valve combinations for manifold 48b is provided in Table <NUM> and described below.

In a first configuration for manifold 48b, isolation valves 96a, 96b, and 96c are opened and isolation valves 96d and 96e are closed, with the laser fiber optic <NUM> being inserted through the isolation valve 96a and first compression fitting <NUM>. This first configuration is an "irrigation-only" configuration, enabling irrigation through both the main working channel <NUM> and the auxiliary working channel <NUM>, with the laser fiber optic <NUM> residing in the main working channel <NUM>.

In a second configuration for manifold 48b, isolation valves 96b, 96c, and 96d are opened and isolation valves 96a and 96e are closed, with the fiber optic <NUM> being inserted through the isolation valve 96d and second compression fitting <NUM>. This second configuration is also an "irrigation-only" configuration, enabling irrigation through both the main working channel <NUM> and the auxiliary working channel <NUM>, but with the laser fiber optic <NUM> residing in the auxiliary working channel <NUM>.

In a third configuration for manifold 48b, isolation valves 96a, 96b, and 96e are opened and isolation valves 96c and 96d are closed, with the laser fiber optic <NUM> inserted through the isolation valve 96a and first compression fitting <NUM>. This third configuration is an "irrigation/aspiration" configuration, with both irrigation and aspiration being enabled to the catheter <NUM>, and with the laser fiber optic <NUM> residing in the main working channel <NUM>.

In a fourth configuration for manifold 48b, isolation valves 96b, 96d, and 96e are opened and isolation valves 96a and 96c are closed, with the laser fiber optic <NUM> inserted through the isolation valve 96d and second compression fitting <NUM>. This fourth configuration is also an "irrigation/aspiration" configuration, with both irrigation and aspiration being enabled to the catheter <NUM>, and with the laser fiber optic <NUM> residing in the auxiliary working channel <NUM>.

In a fifth configuration for manifold 48b, isolation valves 96a and 96e are opened and isolation valves 96b, 96c, and 96d are closed. This fifth configuration is an "aspiration only" configuration, with the laser fiber optic <NUM> residing in the main working channel <NUM>.

In a sixth configuration for manifold 48b, isolation valves 96d and 96e are opened and isolation valves 96a, 96b, and 96c are closed. This sixth configuration is an "aspiration only" configuration, with the laser fiber optic <NUM> residing in the auxiliary working channel <NUM>.

In a seventh configuration for manifold 48b, the isolation valves 96b, 96c, and 96e are closed while the position of isolation valves 96a and 96d are variable and unspecified. This seventh configuration is a "transition" configuration wherein the catheter <NUM> and the output ports <NUM> of the manifold are isolated from the irrigation system <NUM> and the aspiration system <NUM>, while the fiber optic input port <NUM> and the auxiliary working channel input port <NUM> may be opened or closed. The transition configuration may be implemented, for example, when switching the fiber optic <NUM> (or other working device <NUM>) from the main working channel circuit <NUM> to the auxiliary working channel circuit <NUM>, or when switching the fiber optic <NUM> (or other working device <NUM>) from the auxiliary working channel circuit <NUM> to the main working channel circuit <NUM>, as described below attendant to <FIG>.

In an eighth configuration for manifold 48b, all the isolation valves 96a through 96e are closed with the laser fiber optic <NUM> withdrawn. This eighth configuration is a "closed" configuration that completely isolates the catheter <NUM> from the irrigation system <NUM>, the aspiration system <NUM>, and the ablation laser system <NUM>.

Referring to <FIG>, a schematic <NUM> of a manifold 48c operatively coupled to the irrigation system <NUM>, the aspiration system <NUM>, the ablation laser system <NUM>, and the proximal end portion <NUM> of the catheter <NUM> is depicted according to an embodiment of the disclosure. The manifold 48c includes many of the same components and attributes as manifold 48b of <FIG>, which are indicated with same-numbered reference characters.

The manifold 48c includes a selector switch <NUM> for actuating some or all of the plurality of the isolation valves <NUM>. For manifold 48c, the selector switch <NUM> includes a link <NUM> that is coupled to the isolation valves 96b, 96c, and 96e. The selector switch <NUM> may be a three-position switch (depicted) and each of the isolation valves 96b, 96c, and 96e may be three-position valves <NUM> capable of being arranged in three unique flow/isolation orientations (also depicted). The three positions of the selector switch <NUM> are indicated by <NUM>, <NUM>, and <NUM> in the figures. In each position, the respective three-position valve <NUM> either isolates or enables the respective circuit <NUM>.

Functionally, as with manifold 48b, the dedicated aspiration port <NUM> of manifold 48c enables working devices <NUM> to access the auxiliary working channel <NUM> without forfeiting aspiration. The selector switch <NUM> simultaneously actuates the isolation valves 96b, 96c, and 96e, while isolation valves 96a and 96d are actuated individually. Each of the positions of the selector switch <NUM> corresponds to one of the positions of each of the three-position valves <NUM>.

In operation, the selector switch <NUM> as well as isolation valves 96a and 96d may be manipulated to define a plurality operating configurations, each representing a unique input and output combination. A tabulation of example valve combinations for manifold 48c is provided in Table <NUM> and described below.

In a first configuration for manifold 48c, the selector switch <NUM> is set at position <NUM>, corresponding to an "irrigation-only" configuration <NUM> which configures isolation valves 96b, and 96c in an open configuration and isolation valve 96e in a closed configuration. The irrigation-only configuration <NUM> is depicted in <FIG>. Isolation valve 96a is opened and isolation valve 96d is closed, with the laser fiber optic <NUM> being inserted through the isolation valve 96a and first compression fitting <NUM>. In this first configuration, irrigation is enabled through both the main working channel <NUM> and the auxiliary working channel <NUM>, with the laser fiber optic <NUM> residing in the main working channel <NUM>.

In a second configuration for manifold 48c, the selector switch is set at position <NUM> to the same irrigation-only effect as the first configuration. Isolation valve 96d is opened and isolation valve 96a is closed, with the laser fiber optic <NUM> being inserted through the isolation valve 96d and second compression fitting <NUM>. In this second configuration, irrigation is enabled through both the main working channel <NUM> and the auxiliary working channel <NUM>, with the laser fiber optic <NUM> residing in the auxiliary working channel <NUM>.

In a third configuration for manifold 48c, the selector switch <NUM> is set at position <NUM>, corresponding to an "irrigation + aspiration" configuration <NUM> which configures isolation valves 96b, and 96e in an open configuration and isolation valve 96d in a closed configuration. The irrigation + aspiration configuration <NUM> is depicted in <FIG>. Isolation valve 96a is opened and isolation valve 96d is closed, with the laser fiber optic <NUM> being inserted through the isolation valve 96a and first compression fitting <NUM>. In this third configuration, both irrigation and aspiration are enabled to the catheter <NUM>, and with the laser fiber optic <NUM> residing in the main working channel <NUM>.

In a fourth configuration for manifold 48c, the selector switch is set at position <NUM> to the same irrigation + aspiration effect as the third configuration. Isolation valve 96d is opened and isolation valve 96a is closed, with the laser fiber optic <NUM> being inserted through the isolation valve 96d and second compression fitting <NUM>. In this fourth configuration, both irrigation and aspiration are enabled to the catheter <NUM>, with the laser fiber optic <NUM> residing in the auxiliary working channel <NUM>.

In a fifth configuration for manifold 48c, the isolation valves 96b, 96c, and 96e are closed while the position of isolation valves 96a and 96d are variable and unspecified. This fifth configuration is a "transition" configuration wherein the catheter <NUM> and the output ports <NUM> of the manifold are isolated from the irrigation system <NUM> and the aspiration system <NUM>, while the fiber optic input port <NUM> and the auxiliary working channel input port <NUM> may be opened or closed. The transition configuration may be implemented, for example, when switching the fiber optic <NUM> (or other working device <NUM>) from the main working channel circuit <NUM> to the auxiliary working channel circuit <NUM>, or when switching the fiber optic <NUM> (or other working device <NUM>) from the auxiliary working channel circuit <NUM> to the main working channel circuit <NUM>, as described below attendant to <FIG>.

In a sixth configuration for manifold 48c, the selector switch is set at position <NUM>, closing the isolation valves 96b, 96c, and 96e. The isolation valves 96a and 96d are closed with the laser fiber optic <NUM> withdrawn. This sixth configuration is a "closed" configuration that completely isolates the catheter <NUM> from the irrigation system <NUM>, the aspiration system <NUM>, and the ablation laser system <NUM>.

Referring to <FIG>, a schematic <NUM> of a manifold 48d operatively coupled to the irrigation system <NUM>, the aspiration system <NUM>, the ablation laser system <NUM>, and the proximal end portion <NUM> of the catheter <NUM> is depicted according to an embodiment of the disclosure. The manifold 48d includes many of the same components and attributes as manifold 48c of <FIG>, which are indicated with same-numbered reference characters.

Unlike manifold 48c, manifold 48d does not include isolation valves 96a and 96d. Instead of isolating the fiber optic input port <NUM> and the auxiliary working channel input port <NUM>, the compression fittings <NUM> and <NUM> are sealed off either by the presence of the working device <NUM> (e.g. the fiber optic <NUM>, as depicted at fiber optic input port <NUM>) or with a cap or plug <NUM> (depicted at auxiliary working channel input port <NUM>).

In operation, the selector switch <NUM> is manipulated as described attendant to <FIG>. The fiber optic input port <NUM> and the auxiliary working channel input port <NUM> are either occupied with fiber optic <NUM> (or other working device <NUM>) or selectively sealed with cap or plug <NUM>. A tabulation of example valve combinations for manifold 48d is provided in Table <NUM> and described below.

In a first configuration for manifold 48d, the selector switch <NUM> is set at position <NUM>, corresponding to the "irrigation-only" configuration <NUM> (<FIG>). The first compression fitting <NUM> is occupied and sealed with the working device <NUM> (e.g., laser fiber optic <NUM>, depicted). The second compression fitting <NUM> is sealed with cap or plug <NUM>. In this first configuration, irrigation is enabled through both the main working channel <NUM> and the auxiliary working channel <NUM>, with the working device <NUM> residing in the main working channel <NUM>.

In a second configuration for manifold 48d, the selector switch is set at position <NUM> to the same irrigation-only effect as the first configuration. The second compression fitting <NUM> is occupied and sealed with the working device <NUM> (e.g., laser fiber optic <NUM>). The first compression fitting <NUM> is sealed with cap or plug <NUM>. In this second configuration, irrigation is enabled through both the main working channel <NUM> and the auxiliary working channel <NUM>, with the working device <NUM> residing in the auxiliary working channel <NUM>.

In a third configuration for manifold 48d, the selector switch <NUM> is set at position <NUM>, corresponding to an "irrigation + aspiration" configuration <NUM> (<FIG>). The first compression fitting <NUM> is occupied and sealed with the working device <NUM> (e.g., laser fiber optic <NUM>). The second compression fitting <NUM> is sealed with cap or plug <NUM>. In this third configuration, both irrigation and aspiration are enabled to the catheter <NUM>, and with the laser fiber optic <NUM> residing in the main working channel <NUM>.

In a fourth configuration for manifold 48d, the selector switch <NUM> is set at position <NUM> to the same irrigation + aspiration effect as the third configuration. The second compression fitting <NUM> is occupied and sealed with the working device <NUM> (e.g., laser fiber optic <NUM>). The first compression fitting <NUM> is sealed with cap or plug <NUM>. In this fourth configuration, both irrigation and aspiration are enabled to the catheter <NUM>, with the laser fiber optic <NUM> residing in the auxiliary working channel <NUM>.

In a fifth configuration for manifold 48d, the isolation valves 96b, 96c, and 96e are closed while the position of isolation valves 96a and 96d are variable and unspecified. This fifth configuration is a "transition" configuration wherein the catheter <NUM> and the output ports <NUM> of the manifold are isolated from the irrigation system <NUM> and the aspiration system <NUM>, while the fiber optic input port <NUM> and the auxiliary working channel input port <NUM> may be opened or closed. The transition configuration may be implemented, for example, when switching the fiber optic <NUM> (or other working device <NUM>) from the main working channel circuit <NUM> to the auxiliary working channel circuit <NUM>, or when switching the fiber optic <NUM> (or other working device <NUM>) from the auxiliary working channel circuit <NUM> to the main working channel circuit <NUM>, as described below attendant to <FIG>.

In a sixth configuration for manifold 48d, the selector switch <NUM> is set at position <NUM>, closing the isolation valves 96b, 96c, and 96e (<FIG>). The compression fittings <NUM> and <NUM> are sealed with caps or plugs <NUM>, the laser fiber optic <NUM> being withdrawn. This sixth configuration is a "closed" configuration that completely isolates the catheter <NUM> from the irrigation system <NUM>, the aspiration system <NUM>, and the ablation laser system <NUM>.

Referring to <FIG>, a schematic <NUM> of a manifold 48e operatively coupled to the irrigation system <NUM>, the aspiration system <NUM>, the ablation laser system <NUM>, and the proximal end portion <NUM> of the catheter <NUM> is depicted according to an embodiment of the disclosure. The manifold 48e includes many of the same components and attributes as manifold 48d of <FIG>, which are indicated with same-numbered reference characters.

Like manifold 48d, manifold 48e does not include isolation valves 96a and 96d, with alternative arrangements for circuit isolation as described attendant to <FIG>. Unlike manifold 48d, the remaining isolation valves 96b, 96c, and 96e are not coupled to a single selector switch. Instead, isolation valves 96b, 96c, and 96e are individual <NUM>-position valves, akin to schematic <NUM> of <FIG>.

In operation, each of the isolation valves 96b, 96c, and 96e are operated individually. The fiber optic input port <NUM> and the auxiliary working channel input port <NUM> are either occupied with fiber optic <NUM> (or other working device <NUM>) or selectively sealed with the cap or plug <NUM>. A tabulation of example valve combinations for manifold 48e is provided in Table <NUM> and described below.

In a first configuration for manifold 48e, isolation valves 96b is opened, isolation valve 96e is closed, and isolation valve 96c may be opened or closed. If isolation valve 96c is closed, only the first irrigation circuit <NUM> can be flooded with irrigation fluid is opened; if isolation valve 96c is opened, both irrigation circuits <NUM> and <NUM> can be flooded with irrigation fluid. The first compression fitting <NUM> is occupied and sealed with the working device <NUM> (e.g., laser fiber optic <NUM>, depicted). The second compression fitting <NUM> is sealed with cap or plug <NUM>. In this first configuration, irrigation is enabled through both the main working channel <NUM> and the auxiliary working channel <NUM>, with the working device <NUM> residing in the main working channel <NUM>.

In a second configuration for manifold 48e, isolation valves 96b, 96c, and 96e are configured the same as for the first configuration, with the second compression fitting <NUM> being occupied and sealed with the working device <NUM> (e.g., laser fiber optic <NUM>) and the first compression fitting <NUM> being sealed with the plug or cap <NUM>. This second configuration is also an "irrigation-only" configuration, enabling irrigation through the main working channel <NUM> and/or the auxiliary working channel <NUM>, but with the laser fiber optic <NUM> residing in the auxiliary working channel <NUM>.

In a third configuration for manifold 48e, isolation valves 96b and 96c are closed and isolation valve 96e is opened. The working device <NUM> (e.g., laser fiber optic <NUM>) occupies the first compression fitting <NUM>, and the second compression fitting <NUM> is sealed with cap or plug <NUM>. This third configuration is an "aspiration-only" configuration, with only the aspiration circuit <NUM> being enabled, and with the working device <NUM> residing in the main working channel <NUM>.

In a fourth configuration for manifold 48e, isolation valves 96b, 96c, and 96e are configured the same as for the second configuration, with the second compression fitting <NUM> being occupied and sealed with the working device <NUM> (e.g., laser fiber optic <NUM>) and the first compression fitting <NUM> being sealed with the plug or cap <NUM>. This second configuration is also an "irrigation-only" configuration, enabling irrigation through the main working channel <NUM> and/or the auxiliary working channel <NUM>, but with the laser fiber optic <NUM> residing in the auxiliary working channel <NUM>.

In a fifth configuration for manifold 48e, isolation valves 96b and 96e are opened and isolation valve 96c is closed. The working device <NUM> (e.g., laser fiber optic <NUM>) occupies the first compression fitting <NUM>, and the second compression fitting <NUM> is sealed with cap or plug <NUM>. This fifth configuration is an "irrigation/aspiration" configuration, with both irrigation and aspiration being enabled to the catheter <NUM>, and with the working device <NUM> residing in the main working channel <NUM>.

In a sixth configuration for manifold 48e, isolation valves 96b and 96e are opened and isolation valve 96c is closed, with the second compression fitting <NUM> being occupied and sealed with the working device <NUM> (e.g., laser fiber optic <NUM>) and the first compression fitting <NUM> being sealed with the plug or cap <NUM>. This sixth configuration is also an "irrigation/aspiration" configuration, with both irrigation and aspiration being enabled to the catheter <NUM>, and with the laser fiber optic <NUM> residing in the auxiliary working channel <NUM>.

In a seventh configuration for manifold 48e, the isolation valves 96b, 96c, and 96e are closed while the disposition of the compression fittings <NUM> and <NUM> is variable and unspecified. This seventh configuration is a "transition" configuration wherein the catheter <NUM> and the output ports <NUM> of the manifold are isolated from the irrigation system <NUM> and the aspiration system <NUM>, while one of first compression fitting <NUM> and the second compression fitting <NUM> is occupied with the working device <NUM> (e.g., the laser fiber optic <NUM>), and the other of the second compression fitting <NUM> and the first compression fitting <NUM> is occupied with the plug or cap <NUM>. The transition configuration may be implemented, for example, when switching the working device <NUM> from the main working channel circuit <NUM> to the auxiliary working channel circuit <NUM>, or when switching the working device <NUM> from the auxiliary working channel circuit <NUM> to the main working channel circuit <NUM>.

Referring to <FIG>, <FIG>, methods <NUM> of operating the endoscopic system <NUM> are depicted according to embodiments of the disclosure. Method 250a is directed to changing the location of the working device <NUM> (e.g., laser fiber optic <NUM>) at the distal end portion <NUM> of the catheter <NUM>. Method 250b is directed to reversing flow in the catheter <NUM>. Method 250c is directed to selectively increasing irrigation flow through the catheter <NUM>. While the methods <NUM> are described in terms of the endoscopic system <NUM> of the present application, any catheter and steering handle that is suitably equipped may be used in the methods <NUM>.

The methods <NUM> may be embodied in the form of a kit <NUM>, wherein the steering handle <NUM> and catheter <NUM> are provided along with instructions for use <NUM> on a tangible, non-transitory medium <NUM> (<FIG>). Non-limiting examples of a tangible, non-transitory medium <NUM> include a paper document (depicted) or computer-readable media including compact disc and magnetic storage devices (e.g., hard disk, flash drive, cartridge, floppy drive). The computer-readable media may be local or accessible over the internet. The instructions <NUM> may be complete on a single medium, or divided among two or more media. For example, the kit <NUM> may include instructions <NUM> written on a paper document that instruct the operator to access one or more of the steps of the method <NUM> over the internet, the internet-accessible steps being stored on a computer-readable medium or media. The instructions <NUM> may be in the form of written words, figures, and/or video presentations. The methods <NUM> may be executed without the aid of instructions <NUM> or without providing a kit <NUM>. Accordingly, steps <NUM>, <NUM>, and <NUM> of the methods <NUM> are considered optional, as the methods <NUM> may be executed on a steering handle and catheter that has already been provided.

In reference to <FIG>, the method 250a may include placing the distal end portion <NUM> of the catheter <NUM> in a bodily organ (step <NUM>) and leaving the distal end portion <NUM> within the bodily organ during the remaining steps of the method 250a. Examples of bodily organs include into which the distal end portion <NUM> is inserted includes a bladder, a ureter, and a kidney. Step <NUM> is optional, as the method 250a may be executed outside the bodily organ.

The method 250a includes isolating one or both of a first fluid circuit and a second fluid circuit from one or both of an irrigation source and an aspiration source (step <NUM>). In terms of the endoscopic system <NUM>, the first fluid circuit may correspond to either the first irrigation circuit <NUM> or the aspiration circuit <NUM>, and the second fluid circuit may correspond to the other of the aspiration circuit <NUM> or first irrigation circuit <NUM>. Also in terms of the endoscopic system <NUM>, the irrigation source corresponds to irrigation system <NUM> and the aspiration source corresponds to the aspiration system <NUM>. Examples of configurations for step <NUM> include the "transition" configurations of Tables <NUM> through <NUM>. Step <NUM> is optional, as method <NUM> may be performed on a catheter and steering handle that is not connected to an irrigation source and/or an aspiration source.

In some embodiments, the method 250a includes releasing a working device from a first compression fitting of the first fluid circuit (step <NUM>). In terms of the endoscopic system <NUM>, the working device corresponds to the working device <NUM> (e.g., laser fiber optic <NUM>), and the first compression fitting corresponds to the compression fitting <NUM> in which the working device <NUM> resides at the start of the method 250a (e.g., either the first compression fitting <NUM> or the second compression fitting <NUM>). Step <NUM> is optional, as the method 250a may be executed on systems that do not include compression fittings.

The working device <NUM> is removed from the first fluid circuit of the steering handle and the catheter (step <NUM>). In terms of the endoscopic system <NUM>, the working device <NUM> is removed from either the main working channel circuit <NUM> or the aspiration circuit <NUM> in which the working device <NUM> resides at the start of the method 250a.

The working device <NUM> is inserted into the second fluid circuit of the steering handle and the catheter (step <NUM>). In terms of the endoscopic system <NUM>, the working device <NUM> is inserted into either the main working channel circuit <NUM> or the aspiration circuit <NUM> in which the working device <NUM> did not reside at the start of the method 250a.

In some embodiments, the method 250a includes sealing the working device <NUM> with a second compression fitting of the second fluid circuit (step <NUM>). In terms of the endoscopic system <NUM>, the second compression fitting corresponds to the compression fitting <NUM> or <NUM> of the auxiliary working channel circuit <NUM> or the main working channel circuit <NUM> in which the working device <NUM> did not reside at the start of the method 250a. Step <NUM> is optional, as the method 250a may be executed on systems that do not include compression fittings.

Functionally, the method 250a enables the working device of a suitably equipped steering handle and catheter to be changed at the distal end portion <NUM> of the catheter <NUM>. This aspect can enable an operator to change the approach and impingement angle of the ablative laser beam at the target. Such flexibility can improve surgical outcomes. For endoscopic systems that include visual capabilities at the distal end portion <NUM> of the catheter <NUM>, this aspect can also improve the operator's view the working device and laser beam impingement at the target zone. For embodiments enabling the change to be made with the catheter <NUM> inserted in the human body, the change can be made while reducing or avoiding additional time and trauma associated with removing and reinserting the catheter <NUM>.

In reference to <FIG>, the method 250b of reversing flow in the catheter <NUM> is depicted. The method 250b may include coupling the aspiration source <NUM> to the working channel input port <NUM> of the manifold <NUM> of the steering handle <NUM> (step <NUM>). Some embodiments include the dedicated aspiration input channel <NUM> (e.g., manifold 48b), thus negating the need for this step. Accordingly, step <NUM> is an optional step pertinent to embodiments where the aspiration source <NUM> and the working device <NUM> alternatively share the working channel input port <NUM> (e.g., manifold 48a).

In some embodiments, reversing the flow within a first of the lumens <NUM> of the catheter <NUM> entails two steps: a first of the plurality of isolation valves <NUM> of the manifold <NUM> is closed to isolate the lumen <NUM> from either the irrigation source <NUM> or the aspiration source <NUM> (step <NUM>); and a second of the plurality of isolation valves <NUM> of the manifold <NUM> is opened to fluidly connect (i.e., establish fluid communication between) the first of the lumens <NUM> and either the irrigation source <NUM> or the aspiration source <NUM> (step <NUM>).

For example, in reference to manifold 48a (<FIG>), to reverse the flow in the auxiliary working channel <NUM> from an aspiration flow to an irrigation flow, isolation valve 96d is closed for step <NUM>, and isolation valve 96c is opened for step <NUM>. To reverse the flow in the auxiliary working channel <NUM> from an irrigation flow to an aspiration flow, isolation valve 96c is closed for step <NUM>, and isolation valve 96d is opened for step <NUM>.

Functionally, the ability to reverse flow in one of the lumens of a catheter enables remedy imbalance between the irrigation flow and the aspiration flow. For example, if the aspiration flow rate exceeds the irrigation flow rate, the treated organ may constrict, which can cause pain and damage. In this instance, the ability to reverse the aspiration flow and introduce irrigation flow enables the irrigation mass to "catch up" with the aspirated mass (e.g., by configuring the endoscopic system <NUM> for "irrigation only"). Once the irrigation mass sufficiently catches up with the aspirated mass, the flow may again be reversed (e.g., by configuring the endoscopic system <NUM> for "irrigation + aspiration" or "aspiration only") to avoid overfilling the organ. This flexibility enables the operator to work through periods where flow imbalances are encountered, for example due to obstruction caused by the presence of a working device <NUM> or a stone fragment lodged in the aspiration channel. Reversal of the flow may also serve to dislodge an obstructing stone fragment.

In reference to <FIG>, the method 250c of increasing irrigation flow in the catheter <NUM> is depicted. The method 250c may include coupling the irrigation source <NUM> to irrigation input port <NUM> of the manifold <NUM> of the steering handle <NUM> (step <NUM>). In some embodiments, increasing the flow within a first of the lumens <NUM> of the catheter <NUM> entails two steps: a baseline irrigation flow is established through a first of the lumens <NUM> of the catheter <NUM> from the irrigation source <NUM> via the irrigation port <NUM> (step <NUM>); and opening one of the plurality of isolation valves <NUM> of the manifold <NUM> to fluidly connect a second of the lumens <NUM> of the catheter <NUM> to the irrigation source <NUM> (step <NUM>).

For example, in reference to manifold 48a (<FIG>), to increase the irrigation flow through the catheter <NUM>, flow is first established through the first irrigation circuit <NUM> and main working channel <NUM> for step <NUM>. Isolation valve 96c is opened to establish flow through the second irrigation circuit <NUM> and auxiliary working channel <NUM> via the irrigation input port <NUM> for step <NUM>.

Functionally, the ability to increase the irrigation flow through a catheter also enables remedy imbalance between the irrigation flow and the aspiration flow. Again, if the aspiration flow rate exceeds the irrigation flow rate, the treated organ may constrict, which can cause pain and damage. In this instance, the ability to increase the flow irrigation flow rate enables the irrigation mass to "catch up" with the aspirated mass (e.g., by configuring the endoscopic system <NUM> for "irrigation only"). Once the irrigation mass catches up with or exceeds aspirated mass, the irrigation flow may be returned to the baseline flow rate. This flexibility enables the operator to work through periods where flow imbalances are encountered, for example due to obstruction caused by the presence of a working device <NUM> in the irrigation channel.

The methods <NUM> of <FIG> may be executed together, such as concurrently, in sequence, or some combination thereof. For example, the flow reversal method of 250b or increasing the irrigation flow of method 250c may be performed in conjunction with changing the location of the working device of method 250a. Likewise the flow reversal of method 250b may entail increasing the irrigation flow of method 250c. Accordingly, the steps of the methods <NUM> may be combined in ways other than depicted in described in <FIG>.

Referring to <FIG>, steering handles 42a through 42e, respectively, are depicted according to embodiments of the disclosure, each housing manifolds 48a through 48e of <FIG>, respectively. Herein, steering handles are referred to generically or collectively with reference character <NUM>, and individually or specifically with the reference character <NUM> followed by a letter suffix (e.g., "steering handle 42a").

The steering handles <NUM> include a housing <NUM> having a head assembly <NUM> and a base portion <NUM> separated by a body portion <NUM>. The body portion <NUM> defines a handle axis <NUM> along which the head portion <NUM>, body portion <NUM>, and base portion <NUM> are arranged, with the head assembly <NUM> being proximal to the body portion <NUM> and the base portion <NUM> being distal to the body portion <NUM>. Herein, in the context of the steering handles <NUM>, "proximal" refers to a direction <NUM> along the catheter axis <NUM> and the handle axis <NUM> that is toward the head assembly <NUM>, and "distal" refers to a direction <NUM> along the catheter axis <NUM> and the handle axis <NUM> that is away from the head assembly <NUM>. The head assembly <NUM> may include a thumb lever <NUM> for articulating the distal end <NUM> of a catheter <NUM>, as well as one or more push button actuators <NUM> for activating features of the endoscopic system <NUM>.

The base portion <NUM> may include a bulkhead <NUM> through which the main working channel input port <NUM> and the auxiliary working channel input port <NUM> are routed for interfacing with the external systems <NUM>. In some embodiments, the irrigation input port <NUM> and the aspiration port <NUM> extend through the base portion <NUM> distal to the bulkhead <NUM> (<FIG>), but may also be routed through the bulkhead <NUM> (<FIG>). The irrigation input port <NUM> or the aspiration port <NUM> (or both) may be optionally configured for compatibility with LUER taper fittings. In some embodiments, the irrigation input port <NUM> or the aspiration port <NUM> (or both) are fitted with an external valve such as a stopcock valve. The base portion <NUM> may include a catheter port <NUM> to which the catheter <NUM> is coupled, as well as an electrical port <NUM> for routing electrical wiring.

Steering handles 42a, 42b, and 42c include a plurality of rotating two-position valve actuators <NUM> for manipulating the isolation valves <NUM>. In some embodiments, the valve actuators <NUM> extend through the base portion <NUM> of the housing <NUM>. Steering handles 42c and 42d include a selector switch actuator <NUM> for the selector switch <NUM> depicted for manifolds 48c and 48d in <FIG>. Steering handle 42d also depicts the cap or plug <NUM> for sealing the auxiliary working channel input port <NUM>. Steering handle 42e includes a plurality of push button two-position translating valve actuators <NUM> for manipulating the isolation valves <NUM>.

Referring to <FIG>, rotating two-position valve actuators <NUM> are depicted according to embodiments of the disclosure. For steering handles 42a and 42b, all of the isolation valves <NUM> are two-position or binary valves <NUM>, for example rotating stopcock valves <NUM>. For steering handle 42c, only isolation valves 96a and 96d are two-position valves <NUM>. The rotating two-position valve actuators <NUM> as well as the input ports <NUM> may be color coded for ready identification (e.g., orange for irrigation, blue for working device, and white for aspiration). Alternatively or in addition, each valve actuator <NUM> and/or input port <NUM> may be identified in print on the housing <NUM>.

The rotating two-position valve actuators <NUM> may extend through the housing <NUM> and may include lever actuators <NUM> for rotating manipulation by an operator, as depicted in <FIG> and <FIG>. The lever actuators <NUM> are coupled to a stem <NUM> (<FIG>) and may be oriented to be parallel with the direction of flow through a flow orifice <NUM> of the isolation valve <NUM>, the flow orifice <NUM> being defined in the stem <NUM>. The stem <NUM> is inserted into a valve body <NUM> that may be integral or unitary with the housing <NUM>. In some embodiments, each lever actuator <NUM> includes a flange <NUM> that partially surrounds the stem <NUM> and cooperates with a stop <NUM> formed on the valve body <NUM> or housing <NUM> to limit rotation of the rotating two-position valve actuator <NUM> to a fixed angle (e.g., <NUM> degrees, depicted in <FIG>).

In the depicted embodiments, the manifolds <NUM> are oriented so that the fluid circuits <NUM> extend primarily in the proximal and distal directions <NUM>, <NUM>. As such, the isolation valves <NUM> depicted are "open" (i.e., in a flow-enabling orientation) when the lever actuators <NUM> extend substantially parallel to the proximal and distal directions <NUM>, <NUM> (<FIG>), and are "closed" (i.e., in a flow-isolating orientation) when the lever actuators <NUM> are extended substantially perpendicular to the proximal and distal directions <NUM>, <NUM> (<FIG>).

Alternatively, the stopcock valves <NUM> may define tool receptacles <NUM> for actuating the isolation valves <NUM> with a tool (not depicted) as depicted in <FIG>. The tool receptacles <NUM> may be, for example, a slot (depicted) for insertion of a flat head screw driver (not depicted). The stopcock valves <NUM> having tool slots <NUM> may be internal to the housing <NUM>, and may be accessible by removing a portion of the housing <NUM> (depicted), or through access apertures formed on the housing <NUM> (not depicted).

Referring to <FIG>, the selector switch actuator <NUM> is depicted according to an embodiment of the disclosure. The selector switch actuator <NUM> includes a handle portion <NUM> and a stem portion <NUM>, the stem portion <NUM> defining a rotation axis <NUM>. The selector switch actuator <NUM> may include valve cores <NUM> for the isolations valves 96b, 96c, and 96e, and an end bearing <NUM> defining a tangential groove <NUM> configured to receive a retention clip <NUM> (<FIG>). The selector switch actuator <NUM> may also include a cam <NUM>. The valve cores <NUM> define flow orifices <NUM> that define flow axes <NUM>. The flow axes <NUM> extend orthogonally relative to the rotation axis <NUM>, and are laterally offset from the rotation axis <NUM>.

Referring to <FIG>, the selector switch actuator <NUM> is depicted in assembly according to an embodiment of the disclosure. The handle portion <NUM> of the selector switch actuator <NUM> is removed in <FIG> for clarity. The selector switch actuator <NUM> is disposed within a selector switch body <NUM> that may be integral to the manifold 48c, 48d. In some embodiments, the manifold 48c, 48d includes features <NUM> that extend outward and surround the cam <NUM> of the selector switch actuator <NUM>. The cam <NUM> interacts with the features <NUM> to snap and hold the selector switch actuator <NUM> in one of the three positions of the selector switch <NUM>, thereby holding the valve cores <NUM> in desired rotational orientations. The features <NUM> may include stops <NUM> against which the cam <NUM> registers to prevent further rotation of the selector switch actuator <NUM> in a given directions.

Functionally, the selector switch actuator <NUM> cooperates with the selector switch body <NUM> and the features <NUM>, <NUM> of the manifold 48c, 48d to define a three-position selector switch <NUM>. The positions of three-position selector switch <NUM> as depicted corresponds to the "irrigation-only", the "closed", and the "irrigation + aspiration" configurations of the manifolds 48c and 48d.

Referring to <FIG>, operation of the three-position selector switch <NUM> and three-position valves <NUM> is depicted according to an embodiment of the disclosure. The steering handle 42c is depicted in the figures, with the understanding that the same operation also applies to steering handle 42d. "Position <NUM>" as described attendant to <NUM> and <NUM> above is depicted at <FIG>, representing an "irrigation-only" configuration as marked on the housing <NUM>. In position <NUM>, the cam <NUM> engages a first of the features <NUM> as well as one of the stop features <NUM> (<FIG>).

Cross-sectional schematics 396a through 396c of <FIG> (referred to collectively and generically as cross-sections <NUM>) represent the valve cores <NUM> within the valve selector switch body <NUM>. The valve core <NUM> of the cross-sections <NUM> depict two flow orifices <NUM> and <NUM>', the flow orifice <NUM>' being optional and represented in phantom. By way of example, the cross-sections 396a through 396c represent a three-position configuration of isolation valves 96b and 96e as depicted and described for manifolds 48c and 48d. Optional flow orifice <NUM>' is present for isolation 96b and not present for isolation valve 96e. In the cross-sections <NUM>, the selector switch body <NUM> partially defines the conduits <NUM> of the manifold 48c, 48d, such that the conduits <NUM> pass through the selector switch body <NUM> at a location that is laterally offset from the rotation axis <NUM> of the selector switch actuator <NUM> and in alignment with the flow orifice <NUM> when the three-position valve <NUM> is in a flow enabling configuration (<FIG>).

"Position <NUM>" as described attendant to the schematics <NUM> and <NUM> above is depicted at <FIG>, representing a "closed" configuration as marked on the housing <NUM>. The cam <NUM> engages a second of the features <NUM> to secure the selector switch actuator <NUM> in position <NUM> (<FIG>). In the cross-section 396b, the valve core <NUM> obstructs the conduit <NUM>, thereby blocking the conduit <NUM> to isolate the circuit <NUM>.

"Position <NUM>" as described attendant to the schematics <NUM> and <NUM> above is depicted at <FIG>, representing a "closed" configuration as marked on the housing <NUM>. The cam <NUM> engages a third of the features <NUM> as well as one of the stop features <NUM> to secure the selector switch actuator <NUM> in position <NUM> (<FIG>). In the cross section 396c, the valve core <NUM> either obstructs or enables flow through the conduit <NUM> (<FIG>), depending on whether the optional flow orifice <NUM>' is present. That is, for isolation valve 96b, with two flow orifices <NUM> and <NUM>', flow is enabled in <FIG>. For isolation valve 96e, with only one flow orifice <NUM>, flow is blocked in <FIG>. Operation of isolation valve 96c is reversed from that of isolation valve 96b (i.e., being in an isolation configuration at position <NUM> and in a flow enabling configuration at position <NUM>).

In this way, the switch actuator <NUM> cooperates with the selector switch body <NUM> and the features <NUM>, <NUM> of the manifold 48c, 48d to provide the three-position valves <NUM> of the manifolds 48c and 48d.

Referring to <FIG>, the layout and structure of the manifold 48a depicting various aspects of the schematic <NUM> in the physical realm is presented according to an embodiment of the disclosure. A solid model representation <NUM> of the conduits <NUM> through the manifold 48a is depicted at <FIG>. The routing of the conduits through the housing <NUM> is depicted with hidden lines in <FIG>. In the views of <FIG>, the conduits <NUM> of manifold 48a resemble the letter W, with the three input ports <NUM>, <NUM>, and <NUM> being at the top of the W and the output ports <NUM> being at the apexes at the bottom of the W. The manifold 48a is depicted in isolation (with fittings) at <FIG> and in installation in <FIG>. Also, in <FIG>, the valve actuators <NUM> are identified individually as valve actuators 338a through 338d, along with the corresponding isolation valve 96a through 96d.

Referring to <FIG>, the layout and structure of the manifold 48b depicting various aspects of the schematic <NUM> in the physical realm is presented according to an embodiment of the disclosure. A solid model representation <NUM> of the conduits <NUM> through the manifold 48b is depicted at <FIG>. The routing of the conduits through the housing <NUM> is depicted with hidden lines in <FIG>. The manifold 48b is depicted in isolation in <FIG>. In the depicted embodiment, the manifolds 48a, 48b include a matrix structure <NUM> through which the conduits <NUM> pass and which supports the valves <NUM>. The bulkhead <NUM>, conduits <NUM>, and matrix structure <NUM> may be unitary. Also, in <FIG> and <FIG>, the valve actuators <NUM> are identified individually as valve actuators 338a through 338e, along with the corresponding isolation valve 96a through 96e.

For the manifolds 48a and 48b, the conduits <NUM>, and in particular the working channel conduits 90a and 90d of the main working channel circuit <NUM> and the auxiliary working channel circuit <NUM>, are characterized by gradual inflections. The conduits <NUM> also pass through the bulkhead <NUM>. Functionally, the gradual inflections of the main working channel conduit 90a of the main working channel circuit <NUM> and of the auxiliary working channel conduit 90d of the auxiliary working channel circuit <NUM> prevent crimping of working devices <NUM>, enabling smooth insertion. The lack of sharp corners for the irrigation conduits 90b and 90c reduces pressure losses through the irrigation circuits <NUM> and <NUM>. The matrix structure <NUM> provides the manifold <NUM> with ample strength and mounting features, and is amenable to a three-dimensional printing manufacturing technique.

Referring to <FIG>, the layout and structure of the manifold 48d depicting various aspects of the schematic <NUM> in the physical realm is presented according to an embodiment of the disclosure. A sectional view <NUM> of the conduits 90b, 90c, and 90e as they are routed through the three-position selector switch <NUM> are depicted at <FIG>. The routing of the conduits <NUM> through the housing <NUM> is depicted with hidden lines in <FIG>. The manifold 48d is depicted in isolation in <FIG>. The manifold 48d also includes the matrix structure <NUM> through which the conduits <NUM> pass and which supports the valves <NUM>. The bulkhead <NUM>, conduits <NUM>, and matrix structure <NUM> may be unitary.

The main working channel <NUM> defines an inner diameter <NUM> and an outer diameter <NUM> (<FIG>). Likewise, the auxiliary working channel <NUM> defines an inner diameter <NUM> and an outer diameter <NUM>. In some embodiments, one of the working channels <NUM>, <NUM> defines a larger inner diameter <NUM> than the inner diameter <NUM> of the other of the working channels <NUM>, <NUM>. In the depicted embodiment, the auxiliary working channel <NUM> defines the larger inner diameter <NUM> and the main working channel <NUM> defines the smaller inner diameter <NUM>. However, this arrangement may be reversed, or negated by defining inner diameters <NUM>, <NUM> that are of substantially equal size. In some embodiments, the inner diameter <NUM> is within a range of <NUM> millimeters to <NUM> millimeters inclusive. In some embodiments, the inner diameter <NUM> is within a range of <NUM> millimeters to <NUM> millimeters inclusive. The respective outer diameters may accommodate a wall thickness within a range of <NUM> millimeters to <NUM> millimeters inclusive. This arrangement, while depicted for the manifold 48d, may be implemented for any of the disclosed manifolds <NUM>.

The main working channel conduit 90a of the main working channel circuit <NUM> and the auxiliary working channel conduit 90d of the auxiliary working channel circuit <NUM> bypass the three-position selector switch <NUM> (<FIG>). The manifold 48c is similar to manifold 48d, except that manifold 48c includes isolation valves 96a and 96d on the main working channel input port <NUM> and the auxiliary working channel input port <NUM>.

Referring to <FIG>, the layout and structure of the manifold 48e as embodied at <FIG> and depicting various aspects of the schematic <NUM> in the physical realm is presented according to an embodiment of the disclosure. The manifold 48e includes many of the same components and attributes as manifold 48d, which are identified with same-numbered reference characters. Instead of the selector switch <NUM> or rotating two-position valve actuators <NUM> with rotating lever actuators <NUM>, the manifold 48e includes a plurality of two-position valves <NUM> having two-position (push/pull) translating valve actuators <NUM>. The two-position valves <NUM> are sliding valves <NUM> that, in some embodiments, isolate the respective circuit <NUM> when the translating valve actuator <NUM> is pulled outward (away from the manifold 48e) and enables the respective flow circuit <NUM> when the translating valve actuator <NUM> is pushed inward (toward the manifold 48e). In some embodiments, the push/pull action of the sliding valves <NUM> may be reversed; that is, the sliding valves <NUM> may be configured to enable flow by pulling on the translating valve actuators <NUM> and to isolate flow by pushing on the translating valve actuators <NUM>.

Each of <FIG> depict the translating valve actuators <NUM> in a combination that configures the manifold 48e for one or more of the configurations of Table <NUM>. Each of the <FIG> is a sectional view of the manifold 48e of the corresponding <FIG>. The sectional views depict the conduits <NUM> and the sliding valves <NUM>. With respect to Table <NUM>, <FIG> depict the "Irrigation-Only" combinations for configurations (<NUM>) and (<NUM>); <FIG> depict the "Aspiration-Only" combination for configurations (<NUM>) and (<NUM>); <FIG> depict the "Irrigation + Aspiration" combination for configurations (<NUM>) and (<NUM>); and <FIG> depict the "Transition" and "Closed" combination for configurations (<NUM>) and (<NUM>).

Functionally, utilizing the plurality of two-position valves <NUM> instead of the selector switch <NUM> provides the operator with more combinations for operation. An example is the "Aspiration Only" configuration, which is not a configuration of the selector switch <NUM> as depicted herein. The larger and smaller inner diameters <NUM>, <NUM> provides one of the working channels <NUM> (depicted) or <NUM> with larger diameter throughput that extends through the lumens <NUM> of the catheter <NUM>. For a given cross-sectional area of the catheter shaft <NUM>, the allocation of the larger inner diameter <NUM> and the smaller inner diameter <NUM> can provide larger clearance in one of the working channels <NUM>, <NUM> than would be available if both inner diameters <NUM> and <NUM> were of equal dimension. The larger inner diameter <NUM> can provide greater clearance between or at least less interference between the working device <NUM> and the lumen <NUM>, for easier insertion of the working device <NUM>. The larger clearance also enables better flow within the annulus defined between the working device <NUM> and the wall of the lumen <NUM>. Furthermore, where the larger inner diameter <NUM> is utilized in the aspiration circuit <NUM>, the catheter <NUM> is less likely to clog or foul due to the size of the stone fragments being aspirated.

Each of the additional figures and methods disclosed herein can be used separately, or in conjunction with other features and methods, to provide improved devices and methods for making and using the same. Therefore, combinations of features and methods disclosed herein may not be necessary to practice the disclosure in its broadest sense and are instead disclosed merely to particularly describe representative and preferred embodiments.

Various modifications to the embodiments may be apparent to one of skill in the art upon reading this disclosure. For example, persons of ordinary skill in the relevant arts will recognize that the various features described for the different embodiments can be suitably combined, un-combined, and re-combined with other features, alone, or in different combinations. Likewise, the various features described above should all be regarded as example embodiments, rather than limitations to the scope of the disclosure.

Persons of ordinary skill in the relevant arts will recognize that various embodiments can comprise fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features may be combined. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, the claims can comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the art.

Unless indicated otherwise, references to "embodiment(s)", "disclosure", "present disclosure", "embodiment(s) of the disclosure", "disclosed embodiment(s)", and the like contained herein refer to the specification (text, including the claims, and figures) of this patent application that are not admitted prior art.

Claim 1:
An endoscopic surgical instrument, comprising:
a steering handle (<NUM>) including a housing containing a manifold (<NUM>), said manifold including a main working channel input port (<NUM>) in fluid communication with a main working channel output port (<NUM>), an auxiliary working channel input port (<NUM>) in fluid communication with an auxiliary working channel output port (<NUM>), and an irrigation input port (<NUM>) in fluid communication with said main working channel output port (<NUM>) and said auxiliary working channel output port (<NUM>),
wherein said manifold (<NUM>) includes a plurality of valves (<NUM>) for selectively isolating said irrigation input port (<NUM>) from said main working channel output port (<NUM>) and said auxiliary working channel output port (<NUM>);
wherein said irrigation input port (<NUM>) is isolated from said main working channel output port (<NUM>) by a first of said plurality of valves; and
wherein a main working channel circuit includes said main working channel input port (<NUM>) and said main working channel output port (<NUM>), said main working channel circuit being configured to pass a working device therethrough.