STEERING HANDLE WITH MULTI-CHANNEL MANIFOLD

Steering handles with manifolds that enable an operator to configure an endoscopic system in situ for a variety of tasks, including irrigation, aspiration, or both. In addition, the disclosed endoscopic systems facilitate rapid reconfiguration of the location of a laser fiber optic within a catheter assembly. 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. These aspects of the disclosed system reduce the time required to perform laser lithotripsy procedures, with less trauma to the patient.

FIELD OF THE DISCLOSURE

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

BACKGROUND OF THE DISCLOSURE

Kidney stones affect 1 in 500 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 45% 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.

SUMMARY OF THE DISCLOSURE

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, aspiration, or both. 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.

DETAILED DESCRIPTION

Referring toFIG. 1, a schematic of an endoscopic system40for laser lithotripsy is depicted according to an embodiment of the disclosure. The endoscopic system40includes a steering handle42coupled to a catheter44and to a variety of external systems46. The steering handle42includes a manifold48configured to connect to at least some of the external systems46. In some embodiments, the manifold48variously receives inputs from and/or sends outputs to an irrigation system52, a suction or aspiration system54, and a laser system56(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 systems46may be routed through the steering handle42as well, but not necessarily routed through the manifold48(e.g., a light system62and an imaging system64, depicted). The catheter44includes a catheter shaft66defining a central or catheter axis68that extends from a proximal end portion72through a distal end portion74of the catheter shaft66. In some embodiments, the catheter44includes a distal head portion76coupled to the distal end portion74of the catheter shaft66. In some embodiments, the catheter44and the catheter shaft66are flexible (depicted).

Referring toFIG. 2, a schematic80of a manifold48aoperatively coupled to the irrigation system52, the aspiration system54, the laser system56, and the proximal end portion72of the catheter shaft66and catheter44is depicted according to an embodiment of the disclosure. Herein, manifolds are referred to generically or collectively as with reference character48, and individually or specifically with the reference character48followed by a letter suffix (e.g., “manifold48a”). The manifold48aincludes a plurality of input ports92that are in fluid communication with a plurality of output ports94via a plurality of conduits90. A plurality of isolation valves96are operatively coupled to the plurality of conduits90of the manifold48a. In some embodiments, each of the plurality of isolation valves96is coupled to a respective one of the plurality of conduits90. The isolation valves96may 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 ports92may include a compression fitting98.

In some embodiments, the plurality of input ports92may include a main working channel input port102, an irrigation input port104, and an auxiliary working channel input port106. The plurality of output ports94of the manifold48aincludes a main working channel output port122and an auxiliary working channel output port124. The main working channel input port102may be operatively coupled to the ablation laser system56. The irrigation input port104may be coupled to the irrigation system52. The auxiliary working channel input port106may be coupled to the aspiration system54. In some embodiments, the auxiliary working channel input port106accommodates a working device148as an alternative to the aspiration system54. 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 circuits110are defined by unique combinations of the input ports92, conduits90, output ports94, and catheter lumens140, the fluid circuits110being enabled by opening the respective isolation valve96. For the manifold48a, the plurality of circuits110includes a main working channel circuit112, a first irrigation circuit114, an auxiliary working channel circuit116, and a second irrigation circuit118. The main working channel circuit112includes the main working channel input port102, a main working channel conduit90a, the main working channel output port122, and a main working channel142, which are selectively connected through isolation valve96a. The first irrigation circuit114includes the irrigation input port104, a first irrigation conduit90b, the main working channel output port122, and the main working channel142, which are selectively connected through isolation valve96b. The auxiliary working channel circuit116includes the auxiliary working channel input port106, the auxiliary working channel conduit90d, the auxiliary working channel output port124, and an auxiliary working channel144, which are selectively connected through isolation valve96d. The second irrigation circuit118includes the irrigation input port104, a second irrigation conduit90c, the auxiliary working channel output port124, and the auxiliary working channel144, which are selectively connected through isolation valve96c.

The plurality of fluid circuits110and isolation valves96can be manipulated to selectively establish fluid communication between the plurality of input ports92and the plurality of output ports94. In some embodiments, the plurality of isolation valves96are configured to selectively establish fluid communication between the main working channel input port102and the main working channel output port122, the irrigation input port104and the main working channel output port122, the irrigation input port104and the auxiliary working channel output port124, and the auxiliary working channel input port106and the auxiliary working channel output port124.

In some embodiments, the plurality of conduits90include four conduits90athrough90d, and the plurality of isolation valves96include a corresponding four isolation valves96athrough96d. In these embodiments, the main working channel input port102is selectively isolated from the main working channel output port122by a first isolation valve96aof the plurality of isolation valves96, the irrigation input port104is selectively isolated from the main working channel output port122by a second isolation valve96bof the plurality of isolation valves96, the irrigation input port104is selectively isolated from the auxiliary working channel output port124by a third isolation valve96cof the plurality of isolation valves96, and the auxiliary working channel input port106is selectively isolated from the auxiliary working channel output port124by a fourth isolation valve96dof the plurality of isolation valves96. Alternatively, a single three-position valve (not depicted) may be used instead of the two isolation valves96band96c, the three-position valve putting the irrigation port in fluid communication with either one or both of the main working channel output port124the auxiliary working channel output port124.

The catheter44includes a plurality of lumens140that extend through the catheter44and, at least over the length of the catheter shaft66, are parallel to the central axis68. The plurality of lumens140include a main working channel142and an auxiliary working channel144, each In some embodiments, the catheter66defines the main working channel142and the auxiliary working channel144. Each of the main working channel142and the auxiliary working channel144pass through the distal end portion74of the catheter shaft66.

In some embodiments, the fiber optic input port102is fitted with a first compression fitting132of the compression fittings98, the first compression fitting132being configured to accept a laser fiber optic150that is operatively coupled to the laser source of the ablation laser system56. The first compression fitting132may be mounted between the fiber optic input port102and the isolation valve96a(depicted). Alternatively, the isolation valve96amay be mounted between the fiber optic input port102and the first compression fitting132. In some embodiments, the first compression fitting defines the fiber optic input port102. One or more of the compression fittings98may be TUOHY BORST adaptors configured for use with one or more working devices148. In some embodiments, the auxiliary working channel input port106accommodates alternative configurations, with the auxiliary working channel input port106being coupled either to the aspiration system54or to a second compression fitting134of the compression fittings98. The second compression fitting134may be configured one of a variety of working devices148, 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 optic150(depicted) as the working device148.

In some embodiments, the steering handle42and catheter44are pre-assembled or factory installed with the laser fiber optic150in place. The factory installed fiber optic150may be removable, as disclosed herein, or may be permanently installed, with one of the working channels142,144dedicated to housing the laser fiber optic150.

Functionally, the steering handle42integrates various external components or systems46for control and delivery to the catheter44. The plurality of isolation valves96enables the manifold48ato be configured to selectively isolate the auxiliary working channel144from the irrigation input port104and/or the aspiration input port106, as well as enabling the manifold48ato be configured to selectively isolate the main working channel142from the fiber optic input port102and/or the irrigation input port104. The compression fittings98enable passage of the laser fiber optic150or other working devices148while prevent irrigation and/or aspiration liquids from leaking around the working device148during operation. The flexibility of introducing working devices148other than the laser fiber optic150enables the endoscopic system40to be implemented for uses other than ablation therapy. Embodiments that include the option of providing compression fittings132and134on both the fiber optic input port102and the auxiliary working channel input port106enable the laser fiber optic150to be selectively configured for accessing a target zone from either the main working channel142or the auxiliary working channel144of the catheter44.

In operation, the plurality of isolation valves96may be manipulated to define a plurality operating configurations, each representing a unique input and output combination. A tabulation of example valve combinations for manifold48ais provided in Table 1 and described below.

In a first configuration for manifold48a, isolation valves96a,96b, and96care opened and isolation valve96dis closed, with the laser fiber optic150being inserted through the isolation valve96aand first compression fitting132. This first configuration is an “irrigation-only” configuration, enabling irrigation through both the main working channel142and the auxiliary working channel144, with the laser fiber optic150residing in the main working channel142.

TABLE 1Example operating configurations for manifold 48a of FIG. 2ValveValveValveValveConfiguration96a96b96c96d(1)Irrigation-onlyOpen*OpenOpenClosed**Laser Fiber inMain Working Channel(2)Irrigation-onlyClosed**OpenOpenOpen*Laser Fiber inAuxiliary WorkingChannel(3)Irrigation + AspirationOpen*OpenClosedOpen***(4)Aspiration OnlyOpen*ClosedClosedOpen***(5)Transition—ClosedClosed—(6)ClosedClosed**ClosedClosedClosed***with laser fiber optic inserted**with laser fiber optic withdrawn***with laser fiber optic withdrawn AND connected to aspiration system

In a second configuration for manifold48a, isolation valves96b,96c, and96dare opened and isolation valve96ais closed, with the fiber optic150being inserted through the isolation valve96d. In this second configuration, the aspiration system54is disconnected and the second compression fitting134may be coupled to the auxiliary working channel input port106. This second configuration is also an “irrigation-only” configuration, enabling irrigation through both the main working channel142and the auxiliary working channel144, but with the laser fiber optic150residing in the auxiliary working channel144.

In a third configuration for manifold48a, isolation valves96a,96b, and96dare opened and isolation valve96cis closed, with the laser fiber optic150inserted through the isolation valve96aand first compression fitting132. This third configuration is an “irrigation/aspiration” configuration, with both irrigation and aspiration being enabled to the catheter44, and with the laser fiber optic150residing in the main working channel142.

In a fourth configuration for manifold48a, isolation valves96aand96dare opened and isolation valves96band96care closed. This fourth configuration is an “aspiration only” configuration, with the laser fiber optic150residing in the main working channel142.

In a fifth configuration for manifold48a, the isolation valves96band96care closed while the position of isolation valves96aand96dare variable and unspecified. This fifth configuration is a “transition” configuration wherein the catheter44and the output ports94of the manifold are isolated from the irrigation system52and the aspiration system54, while the fiber optic input port102and the auxiliary working channel input port106may be opened or closed. The transition configuration may be implemented, for example, when switching the fiber optic150(or other working device148) from the main working channel circuit112to the auxiliary working channel circuit116, or when switching the fiber optic150(or other working device148) from the auxiliary working channel circuit116to the main working channel circuit112, as described below attendant toFIG. 7.

In a sixth configuration for manifold48a, all the isolation valves96athrough96dare closed with the laser fiber optic150withdrawn. This sixth configuration is a “closed” configuration that completely isolates the catheter44from the irrigation system52, the aspiration system54, and the ablation laser system56.

Referring toFIG. 3, a schematic180of a manifold48boperatively coupled to the irrigation system52, the aspiration system54, the ablation laser system56, and the proximal end portion72of the catheter44is depicted according to an embodiment of the disclosure. The manifold48bincludes many of the same components and attributes as manifold48aofFIG. 2, which are indicated with same-numbered reference characters.

In addition, manifold48bincludes a dedicated aspiration port182as one of the plurality of input ports92. In some embodiments, both the auxiliary working channel input port106and the aspiration port182access the same conduit90(i.e., auxiliary working channel conduit90d). The manifold48bmay also include an isolation valve96eas one of the plurality of isolation valves96. The isolation valve96dmay be mounted between the auxiliary working channel input port106and the second compression fitting134(depicted). Alternatively, the second compression fitting134may be mounted between the auxiliary working channel input port106and the isolation valve96d. In some embodiments, the second compression fitting134defines the auxiliary working channel input port106.

For the manifold48b, the plurality of fluid circuits110includes an aspiration circuit184. The aspiration circuit184includes the aspiration port182, the auxiliary working channel conduit90d, the auxiliary working channel output port124, and the auxiliary working channel144, which are selectively connected through isolation valve96e.

Functionally, the dedicated aspiration port182enables working devices148to access the auxiliary working channel144without forfeiting aspiration. As such, the auxiliary working channel144can accommodate the working device148(e.g., laser fiber optic150) and also serve as an aspiration channel.

In operation, the plurality of isolation valves96may be manipulated to define a plurality operating configurations, each representing a unique input and output combination. A tabulation of example valve combinations for manifold48bis provided in Table 2 and described below.

In a first configuration for manifold48b, isolation valves96a,96b, and96care opened and isolation valves96dand96eare closed, with the laser fiber optic150being inserted through the isolation valve96aand first compression fitting132. This first configuration is an “irrigation-only” configuration, enabling irrigation through both the main working channel142and the auxiliary working channel144, with the laser fiber optic150residing in the main working channel142.

In a second configuration for manifold48b, isolation valves96b,96c, and96dare opened and isolation valves96aand96eare closed, with the fiber optic150being inserted through the isolation valve96dand second compression fitting134. This second configuration is also an “irrigation-only” configuration, enabling irrigation through both the main working channel142and the auxiliary working channel144, but with the laser fiber optic150residing in the auxiliary working channel144.

In a third configuration for manifold48b, isolation valves96a,96b, and96eare opened and isolation valves96cand96dare closed, with the laser fiber optic150inserted through the isolation valve96aand first compression fitting132. This third configuration is an “irrigation/aspiration” configuration, with both irrigation and aspiration being enabled to the catheter44, and with the laser fiber optic150residing in the main working channel142.

In a fourth configuration for manifold48b, isolation valves96b,96d, and96eare opened and isolation valves96aand96care closed, with the laser fiber optic150inserted through the isolation valve96dand second compression fitting134. This fourth configuration is also an “irrigation/aspiration” configuration, with both irrigation and aspiration being enabled to the catheter44, and with the laser fiber optic150residing in the auxiliary working channel144.

In a fifth configuration for manifold48b, isolation valves96aand96eare opened and isolation valves96b,96c, and96dare closed. This fifth configuration is an “aspiration only” configuration, with the laser fiber optic150residing in the main working channel142.

In a sixth configuration for manifold48b, isolation valves96dand96eare opened and isolation valves96a,96b, and96care closed. This sixth configuration is an “aspiration only” configuration, with the laser fiber optic150residing in the auxiliary working channel144.

In a seventh configuration for manifold48b, the isolation valves96b,96c, and96eare closed while the position of isolation valves96aand96dare variable and unspecified. This seventh configuration is a “transition” configuration wherein the catheter44and the output ports94of the manifold are isolated from the irrigation system52and the aspiration system54, while the fiber optic input port102and the auxiliary working channel input port106may be opened or closed. The transition configuration may be implemented, for example, when switching the fiber optic150(or other working device148) from the main working channel circuit112to the auxiliary working channel circuit116, or when switching the fiber optic150(or other working device148) from the auxiliary working channel circuit116to the main working channel circuit112, as described below attendant toFIG. 7.

In an eighth configuration for manifold48b, all the isolation valves96athrough96eare closed with the laser fiber optic150withdrawn. This eighth configuration is a “closed” configuration that completely isolates the catheter44from the irrigation system52, the aspiration system54, and the ablation laser system56.

Referring toFIGS. 4 through 6, a schematic200of a manifold48coperatively coupled to the irrigation system52, the aspiration system54, the ablation laser system56, and the proximal end portion72of the catheter44is depicted according to an embodiment of the disclosure. The manifold48cincludes many of the same components and attributes as manifold48bofFIG. 3, which are indicated with same-numbered reference characters.

The manifold48cincludes a selector switch202for actuating some or all of the plurality of the isolation valves98. For manifold48c, the selector switch202includes a link204that is coupled to the isolation valves96b,96c, and96e. The selector switch202may be a three-position switch (depicted) and each of the isolation valves96b,96c, and96emay be three-position valves206capable of being arranged in three unique flow/isolation orientations (also depicted). The three positions of the selector switch202are indicated by 1, 2, and 3 in the figures. In each position, the respective three-position valve206either isolates or enables the respective circuit110.

Functionally, as with manifold48b, the dedicated aspiration port182of manifold48cenables working devices148to access the auxiliary working channel144without forfeiting aspiration. The selector switch202simultaneously actuates the isolation valves96b,96c, and96e, while isolation valves96aand96dare actuated individually. Each of the positions of the selector switch202corresponds to one of the positions of each of the three-position valves206.

In operation, the selector switch202as well as isolation valves96aand96dmay be manipulated to define a plurality operating configurations, each representing a unique input and output combination. A tabulation of example valve combinations for manifold48cis provided in Table 3 and described below.

In a first configuration for manifold48c, the selector switch202is set at position 1, corresponding to an “irrigation-only” configuration212which configures isolation valves96b, and96cin an open configuration and isolation valve96ein a closed configuration. The irrigation-only configuration212is depicted inFIG. 4. Isolation valve96ais opened and isolation valve96dis closed, with the laser fiber optic150being inserted through the isolation valve96aand first compression fitting132. In this first configuration, irrigation is enabled through both the main working channel142and the auxiliary working channel144, with the laser fiber optic150residing in the main working channel142.

In a second configuration for manifold48c, the selector switch is set at position 1 to the same irrigation-only effect as the first configuration. Isolation valve96dis opened and isolation valve96ais closed, with the laser fiber optic150being inserted through the isolation valve96dand second compression fitting134. In this second configuration, irrigation is enabled through both the main working channel142and the auxiliary working channel144, with the laser fiber optic150residing in the auxiliary working channel144.

In a third configuration for manifold48c, the selector switch202is set at position 3, corresponding to an “irrigation+aspiration” configuration212which configures isolation valves96b, and96ein an open configuration and isolation valve96din a closed configuration. The irrigation+aspiration configuration212is depicted inFIG. 6. Isolation valve96ais opened and isolation valve96dis closed, with the laser fiber optic150being inserted through the isolation valve96aand first compression fitting132. In this third configuration, both irrigation and aspiration are enabled to the catheter44, and with the laser fiber optic150residing in the main working channel142.

In a fourth configuration for manifold48c, the selector switch is set at position 3 to the same irrigation+aspiration effect as the third configuration. Isolation valve96dis opened and isolation valve96ais closed, with the laser fiber optic150being inserted through the isolation valve96dand second compression fitting134. In this fourth configuration, both irrigation and aspiration are enabled to the catheter44, with the laser fiber optic150residing in the auxiliary working channel144.

In a fifth configuration for manifold48c, the isolation valves96b,96c, and96eare closed while the position of isolation valves96aand96dare variable and unspecified. This fifth configuration is a “transition” configuration wherein the catheter44and the output ports94of the manifold are isolated from the irrigation system52and the aspiration system54, while the fiber optic input port102and the auxiliary working channel input port106may be opened or closed. The transition configuration may be implemented, for example, when switching the fiber optic150(or other working device148) from the main working channel circuit112to the auxiliary working channel circuit116, or when switching the fiber optic150(or other working device148) from the auxiliary working channel circuit116to the main working channel circuit112, as described below attendant toFIG. 7.

In a sixth configuration for manifold48c, the selector switch is set at position 2, closing the isolation valves96b,96c, and96e. The isolation valves96aand96dare closed with the laser fiber optic150withdrawn. This sixth configuration is a “closed” configuration that completely isolates the catheter44from the irrigation system52, the aspiration system54, and the ablation laser system56.

Referring toFIG. 7, a schematic230of a manifold48doperatively coupled to the irrigation system52, the aspiration system54, the ablation laser system56, and the proximal end portion72of the catheter44is depicted according to an embodiment of the disclosure. The manifold48dincludes many of the same components and attributes as manifold48cofFIGS. 4 through 6, which are indicated with same-numbered reference characters.

Unlike manifold48c, manifold48ddoes not include isolation valves96aand96d. Instead of isolating the fiber optic input port102and the auxiliary working channel input port106, the compression fittings132and134are scaled off either by the presence of the working device148(e.g. the fiber optic10, as depicted at fiber optic input port102) or with a cap or plug232(depicted at auxiliary working channel input port106).

In operation, the selector switch202is manipulated as described attendant toFIGS. 4 through 6. The fiber optic input port102and the auxiliary working channel input port106are either occupied with fiber optic150(or other working device148) or selectively sealed with cap or plug232. A tabulation of example valve combinations for manifold48dis provided in Table 4 and described below.

In a first configuration for manifold48d, the selector switch202is set at position 1, corresponding to the “irrigation-only” configuration212(FIG. 7). The first compression fitting132is occupied and sealed with the working device148(e.g., laser fiber optic150, depicted). The second compression fitting134is sealed with cap or plug232. In this first configuration, irrigation is enabled through both the main working channel142and the auxiliary working channel144, with the working device148residing in the main working channel142.

In a second configuration for manifold48d, the selector switch is set at position 1 to the same irrigation-only effect as the first configuration. The second compression fitting134is occupied and sealed with the working device148(e.g., laser fiber optic150). The first compression fitting132is sealed with cap or plug232. In this second configuration, irrigation is enabled through both the main working channel142and the auxiliary working channel144, with the working device148residing in the auxiliary working channel144.

In a third configuration for manifold48d, the selector switch202is set at position 3, corresponding to an “irrigation+aspiration” configuration214(FIG. 6). The first compression fitting132is occupied and sealed with the working device148(e.g., laser fiber optic150). The second compression fitting134is sealed with cap or plug232. In this third configuration, both irrigation and aspiration are enabled to the catheter44, and with the laser fiber optic150residing in the main working channel142.

In a fourth configuration for manifold48d, the selector switch202is set at position 3 to the same irrigation+aspiration effect as the third configuration. The second compression fitting134is occupied and sealed with the working device148(e.g., laser fiber optic150). The first compression fitting132is sealed with cap or plug232. In this fourth configuration, both irrigation and aspiration are enabled to the catheter44, with the laser fiber optic150residing in the auxiliary working channel144.

In a fifth configuration for manifold48d, the isolation valves96b,96c, and96eare closed while the position of isolation valves96aand96dare variable and unspecified. This fifth configuration is a “transition” configuration wherein the catheter44and the output ports94of the manifold are isolated from the irrigation system52and the aspiration system54, while the fiber optic input port102and the auxiliary working channel input port106may be opened or closed. The transition configuration may be implemented, for example, when switching the fiber optic150(or other working device148) from the main working channel circuit112to the auxiliary working channel circuit116, or when switching the fiber optic150(or other working device148) from the auxiliary working channel circuit116to the main working channel circuit112, as described below attendant toFIG. 7.

In a sixth configuration for manifold48d, the selector switch202is set at position 2, closing the isolation valves96b,96c, and96e(FIG. 5). The compression fittings132and134are sealed with caps or plugs232, the laser fiber optic150being withdrawn. This sixth configuration is a “closed” configuration that completely isolates the catheter44from the irrigation system52, the aspiration system54, and the ablation laser system56.

Referring toFIG. 8, a schematic240of a manifold48eoperatively coupled to the irrigation system52, the aspiration system54, the ablation laser system56, and the proximal end portion72of the catheter44is depicted according to an embodiment of the disclosure. The manifold48eincludes many of the same components and attributes as manifold48dofFIG. 7, which are indicated with same-numbered reference characters.

Like manifold48d, manifold48edoes not include isolation valves96aand96d, with alternative arrangements for circuit isolation as described attendant toFIG. 7. Unlike manifold48d, the remaining isolation valves96b,96c, and96eare not coupled to a single selector switch. Instead, isolation valves96b,96c, and96eare individual 2-position valves, akin to schematic180ofFIG. 3.

In operation, each of the isolation valves96b,96c, and96eare operated individually. The fiber optic input port102and the auxiliary working channel input port106are either occupied with fiber optic150(or other working device148) or selectively scaled with the cap or plug232. A tabulation of example valve combinations for manifold48eis provided in Table 5 and described below.

In a first configuration for manifold48e, isolation valves96bis opened, isolation valve96cis closed, and isolation valve96cmay be opened or closed. If isolation valve96cis closed, only the first irrigation circuit114can be flooded with irrigation fluid is opened; if isolation valve96cis opened, both irrigation circuits114and118can be flooded with irrigation fluid. The first compression fitting132is occupied and sealed with the working device148(e.g., laser fiber optic150, depicted). The second compression fitting134is sealed with cap or plug232. In this first configuration, irrigation is enabled through both the main working channel142and the auxiliary working channel144, with the working device148residing in the main working channel142.

In a second configuration for manifold48e, isolation valves96b,96c, and96eare configured the same as for the first configuration, with the second compression fitting134being occupied and sealed with the working device148(e.g., laser fiber optic150) and the first compression fitting132being sealed with the plug or cap232. This second configuration is also an “irrigation-only” configuration, enabling irrigation through the main working channel142and/or the auxiliary working channel144, but with the laser fiber optic150residing in the auxiliary working channel144.

In a third configuration for manifold48e, isolation valves96band96care closed and isolation valve96eis opened. The working device148(e.g., laser fiber optic150) occupies the first compression fitting132, and the second compression fitting134is sealed with cap or plug232. This third configuration is an “aspiration-only” configuration, with only the aspiration circuit184being enabled, and with the working device148residing in the main working channel142.

In a fourth configuration for manifold48e, isolation valves96b,96c, and96eare configured the same as for the second configuration, with the second compression fitting134being occupied and sealed with the working device148(e.g., laser fiber optic150) and the first compression fitting132being sealed with the plug or cap232. This second configuration is also an “irrigation-only” configuration, enabling irrigation through the main working channel142and/or the auxiliary working channel144, but with the laser fiber optic150residing in the auxiliary working channel144.

In a fifth configuration for manifold48e, isolation valves96band96eare opened and isolation valve96cis closed. The working device148(e.g., laser fiber optic150) occupies the first compression fitting132, and the second compression fitting134is sealed with cap or plug232. This fifth configuration is an “irrigation/aspiration” configuration, with both irrigation and aspiration being enabled to the catheter44, and with the working device148residing in the main working channel142.

In a sixth configuration for manifold48e, isolation valves96band96eare opened and isolation valve96cis closed, with the second compression fitting134being occupied and scaled with the working device148(e.g., laser fiber optic150) and the first compression fitting132being sealed with the plug or cap232. This sixth configuration is also an “irrigation/aspiration” configuration, with both irrigation and aspiration being enabled to the catheter44, and with the laser fiber optic150residing in the auxiliary working channel144.

In a seventh configuration for manifold48e, the isolation valves96b,96c, and96eare closed while the disposition of the compression fittings132and134is variable and unspecified. This seventh configuration is a “transition” configuration wherein the catheter44and the output ports94of the manifold are isolated from the irrigation system52and the aspiration system54, while one of first compression fitting132and the second compression fitting134is occupied with the working device148(e.g., the laser fiber optic150), and the other of the second compression fitting134and the first compression fitting132is occupied with the plug or cap232. The transition configuration may be implemented, for example, when switching the working device148from the main working channel circuit112to the auxiliary working channel circuit116, or when switching the working device148from the auxiliary working channel circuit116to the main working channel circuit112.

In an eighth configuration for manifold48b, all the isolation valves96athrough96eare closed with the laser fiber optic150withdrawn. This eighth configuration is a “closed” configuration that completely isolates the catheter44from the irrigation system52, the aspiration system54, and the ablation laser system56.

Referring toFIGS. 9A, 9B and 9C, methods250of operating the endoscopic system40are depicted according to embodiments of the disclosure. Method250ais directed to changing the location of the working device148(e.g., laser fiber optic150) at the distal end portion74of the catheter44. Method250bis directed to reversing flow in the catheter44. Method250cis directed to selectively increasing irrigation flow through the catheter44. While the methods250are described in terms of the endoscopic system40of the present application, any catheter and steering handle that is suitably equipped may be used in the methods250.

The methods250may be embodied in the form of a kit252, wherein the steering handle42and catheter44are provided along with instructions for use254on a tangible, non-transitory medium256(FIG. 1). Non-limiting examples of a tangible, non-transitory medium256include 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 instructions254may be complete on a single medium, or divided among two or more media. For example, the kit252may include instructions254written on a paper document that instruct the operator to access one or more of the steps of the method250over the internet, the internet-accessible steps being stored on a computer-readable medium or media. The instructions254may be in the form of written words, figures, and/or video presentations. The methods250may be executed without the aid of instructions254or without providing a kit252. Accordingly, steps261,271, and281of the methods250are considered optional, as the methods250may be executed on a steering handle and catheter that has already been provided.

In reference toFIG. 9A, the method250amay include placing the distal end portion74of the catheter44in a bodily organ (step262) and leaving the distal end portion74within the bodily organ during the remaining steps of the method250a. Examples of bodily organs include into which the distal end portion74is inserted includes a bladder, a ureter, and a kidney. Step262is optional, as the method250amay be executed outside the bodily organ.

The method250aincludes 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 (step263). In terms of the endoscopic system40, the first fluid circuit may correspond to either the first irrigation circuit114or the aspiration circuit116, and the second fluid circuit may correspond to the other of the aspiration circuit116or first irrigation circuit114. Also in terms of the endoscopic system40, the irrigation source corresponds to irrigation system52and the aspiration source corresponds to the aspiration system54. Examples of configurations for step263include the “transition” configurations of Tables 1 through 4. Step263is optional, as method250may 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 method250aincludes releasing a working device from a first compression fitting of the first fluid circuit (step264). In terms of the endoscopic system40, the working device corresponds to the working device148(e.g., laser fiber optic150), and the first compression fitting corresponds to the compression fitting98in which the working device148resides at the start of the method250a(e.g., either the first compression fitting132or the second compression fitting134). Step264is optional, as the method250amay be executed on systems that do not include compression fittings.

The working device148is removed from the first fluid circuit of the steering handle and the catheter (step265). In terms of the endoscopic system40, the working device148is removed from either the main working channel circuit112or the aspiration circuit116in which the working device148resides at the start of the method250a.

The working device148is inserted into the second fluid circuit of the steering handle and the catheter (step266). In terms of the endoscopic system40, the working device148is inserted into either the main working channel circuit112or the aspiration circuit116in which the working device148did not reside at the start of the method250a.

In some embodiments, the method250aincludes sealing the working device148with a second compression fitting of the second fluid circuit (step267). In terms of the endoscopic system40, the second compression fitting corresponds to the compression fitting134or132of the auxiliary working channel circuit116or the main working channel circuit112in which the working device148did not reside at the start of the method250a. Step267is optional, as the method250amay be executed on systems that do not include compression fittings.

Functionally, the method250aenables the working device of a suitably equipped steering handle and catheter to be changed at the distal end portion74of the catheter44. 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 portion74of the catheter44, 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 catheter44inserted in the human body, the change can be made while reducing or avoiding additional time and trauma associated with removing and reinserting the catheter44.

In reference toFIG. 9B, the method250bof reversing flow in the catheter44is depicted. The method250bmay include coupling the aspiration source54to the working channel input port106of the manifold48of the steering handle42(step272). Some embodiments include the dedicated aspiration input channel182(e.g., manifold48b), thus negating the need for this step. Accordingly, step272is an optional step pertinent to embodiments where the aspiration source54and the working device148alternatively share the working channel input port106(e.g., manifold48a).

In some embodiments, reversing the flow within a first of the lumens140of the catheter44entails two steps: a first of the plurality of isolation valves96of the manifold48is closed to isolate the lumen140from either the irrigation source52or the aspiration source54(step273); and a second of the plurality of isolation valves96of the manifold48is opened to fluidly connect (i.e., establish fluid communication between) the first of the lumens140and either the irrigation source52or the aspiration source54(step274).

For example, in reference to manifold48a(FIG. 2), to reverse the flow in the auxiliary working channel144from an aspiration flow to an irrigation flow, isolation valve96dis closed for step273, and isolation valve96cis opened for step274. To reverse the flow in the auxiliary working channel144from an irrigation flow to an aspiration flow, isolation valve96cis closed for step273, and isolation valve96dis opened for step274.

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 system40for “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 system40for “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 device138or a stone fragment lodged in the aspiration channel. Reversal of the flow may also serve to dislodge an obstructing stone fragment.

In reference toFIG. 9C, the method250cof increasing irrigation flow in the catheter44is depicted. The method250cmay include coupling the irrigation source52to irrigation input port104of the manifold48of the steering handle42(step282). In some embodiments, increasing the flow within a first of the lumens140of the catheter44entails two steps: a baseline irrigation flow is established through a first of the lumens140of the catheter44from the irrigation source52via the irrigation port104(step283); and opening one of the plurality of isolation valves96of the manifold48to fluidly connect a second of the lumens140of the catheter44to the irrigation source52(step284).

For example, in reference to manifold48a(FIG. 2), to increase the irrigation flow through the catheter44, flow is first established through the first irrigation circuit114and main working channel142for step283. Isolation valve96cis opened to establish flow through the second irrigation circuit116and auxiliary working channel144via the irrigation input port104for step284.

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 system40for “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 device138in the irrigation channel.

The methods250ofFIGS. 9A through 9Cmay be executed together, such as concurrently, in sequence, or some combination thereof. For example, the flow reversal method of250bor increasing the irrigation flow of method250cmay be performed in conjunction with changing the location of the working device of method250a. Likewise the flow reversal of method250bmay entail increasing the irrigation flow of method250c. Accordingly, the steps of the methods250may be combined in ways other than depicted in described inFIGS. 9A through 9C.

Referring toFIGS. 10 through 14, steering handles42athrough42e, respectively, are depicted according to embodiments of the disclosure, each housing manifolds48athrough48eofFIGS. 2 through 8, respectively. Herein, steering handles are referred to generically or collectively with reference character42, and individually or specifically with the reference character42followed by a letter suffix (e.g., “steering handle42a”).

The steering handles42include a housing302having a head assembly304and a base portion306separated by a body portion308. The body portion308defines a handle axis310along which the head portion304, body portion308, and base portion306are arranged, with the head assembly304being proximal to the body portion308and the base portion306being distal to the body portion308. Herein, in the context of the steering handles42, “proximal” refers to a direction312along the catheter axis68and the handle axis310that is toward the head assembly304, and “distal” refers to a direction314along the catheter axis68and the handle axis310that is away from the head assembly304. The head assembly304may include a thumb lever316for articulating the distal end74of a catheter44, as well as one or more push button actuators318for activating features of the endoscopic system40.

The base portion306may include a bulkhead332through which the main working channel input port102and the auxiliary working channel input port106are routed for interfacing with the external systems46. In some embodiments, the irrigation input port104and the aspiration port182extend through the base portion306distal to the bulkhead332(FIGS. 10 and 11), but may also be routed through the bulkhead332(FIGS. 12 through 14). The irrigation input port104or the aspiration port182(or both) may be optionally configured for compatibility with LUER taper fittings. In some embodiments, the irrigation input port104or the aspiration port182(or both) are fitted with an external valve such as a stopcock valve. The base portion306may include a catheter port334to which the catheter44is coupled, as well as an electrical port336for routing electrical wiring.

Steering handles42a,42b, and42cinclude a plurality of rotating two-position valve actuators338for manipulating the isolation valves96. In some embodiments, the valve actuators338extend through the base portion46of the housing302. Steering handles42cand42dinclude a selector switch actuator360for the selector switch202depicted for manifolds48cand48dinFIGS. 4 through 7. Steering handle42dalso depicts the cap or plug232for sealing the auxiliary working channel input port106. Steering handle42eincludes a plurality of push button two-position translating valve actuators340for manipulating the isolation valves96.

Referring toFIGS. 15 through 17, rotating two-position valve actuators338are depicted according to embodiments of the disclosure. For steering handles42aand42b, all of the isolation valves96are two-position or binary valves342, for example rotating stopcock valves344. For steering handle42c, only isolation valves96aand96dare two-position valves342. The rotating two-position valve actuators338as well as the input ports92may 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 actuator338and/or input port92may be identified in print on the housing302.

The rotating two-position valve actuators338may extend through the housing302and may include lever actuators346for rotating manipulation by an operator, as depicted inFIGS. 15 through 15C and 15. The lever actuators346are coupled to a stem348(FIG. 15A) and may be oriented to be parallel with the direction of flow through a flow orifice349of the isolation valve96, the flow orifice349being defined in the stem348. The stem348is inserted into a valve body343that may be integral or unitary with the housing302. In some embodiments, each lever actuator346includes a flange345that partially surrounds the stem348and cooperates with a stop347formed on the valve body343or housing302to limit rotation of the rotating two-position valve actuator338to a fixed angle (e.g., 90 degrees, depicted inFIGS. 15B and 15C).

In the depicted embodiments, the manifolds48are oriented so that the fluid circuits110extend primarily in the proximal and distal directions312,314. As such, the isolation valves96depicted are “open” (i.e., in a flow-enabling orientation) when the lever actuators346extend substantially parallel to the proximal and distal directions312,314(FIG. 15), and are “closed” (i.e., in a flow-isolating orientation) when the lever actuators346are extended substantially perpendicular to the proximal and distal directions312,314(FIG. 16).

Alternatively, the stopcock valves344may define tool receptacles350for actuating the isolation valves96with a tool (not depicted) as depicted inFIGS. 17 and 18. The tool receptacles350may be, for example, a slot (depicted) for insertion of a flat head screw driver (not depicted). The stopcock valves344having tool slots350may be internal to the housing302, and may be accessible by removing a portion of the housing302(depicted), or through access apertures formed on the housing302(not depicted).

Referring toFIG. 19, the selector switch actuator360is depicted according to an embodiment of the disclosure. The selector switch actuator360includes a handle portion362and a stem portion364, the stem portion364defining a rotation axis366. The selector switch actuator360may include valve cores368for the isolations valves96b,96c, and96e, and an end bearing368defining a tangential groove372configured to receive a retention clip374(FIG. 30). The selector switch actuator360may also include a cam376. The valve cores368define flow orifices382that define flow axes384. The flow axes384extend orthogonally relative to the rotation axis366, and are laterally offset from the rotation axis366.

Referring toFIG. 20, the selector switch actuator360is depicted in assembly according to an embodiment of the disclosure. The handle portion362of the selector switch actuator360is removed inFIG. 20for clarity. The selector switch actuator360is disposed within a selector switch body386that may be integral to the manifold48c,48d. In some embodiments, the manifold48c,48dincludes features388that extend outward and surround the cam370of the selector switch actuator360. The cam370interacts with the features388to snap and hold the selector switch actuator360in one of the three positions of the selector switch202, thereby holding the valve cores368in desired rotational orientations. The features388may include stops392against which the cam370registers to prevent further rotation of the selector switch actuator360in a given directions.

Functionally, the selector switch actuator360cooperates with the selector switch body386and the features388,392of the manifold48c,48dto define a three-position selector switch394. The positions of three-position selector switch394as depicted corresponds to the “irrigation-only”, the “closed”, and the “irrigation+aspiration” configurations of the manifolds48cand48d.

Referring toFIGS. 20A through 22C, operation of the three-position selector switch394and three-position valves206is depicted according to an embodiment of the disclosure. The steering handle42cis depicted in the figures, with the understanding that the same operation also applies to steering handle42d. “Position 1” as described attendant to200and230above is depicted atFIGS. 20A through 20C, representing an “irrigation-only” configuration as marked on the housing302. In position 1, the cam370engages a first of the features388as well as one of the stop features382(FIG. 20B).

Cross-sectional schematics396athrough396cofFIGS. 20C, 21C, and 22C(referred to collectively and generically as cross-sections396) represent the valve cores368within the valve selector switch body386. The valve core368of the cross-sections396depict two flow orifices382and382′, the flow orifice382′ being optional and represented in phantom. By way of example, the cross-sections396athrough396crepresent a three-position configuration of isolation valves96band96eas depicted and described for manifolds48cand48d. Optional flow orifice382′ is present for isolation96band not present for isolation valve96e. In the cross-sections396, the selector switch body386partially defines the conduits90of the manifold48c,48d, such that the conduits90pass through the selector switch body386at a location that is laterally offset from the rotation axis366of the selector switch actuator360and in alignment with the flow orifice382when the three-position valve206is in a flow enabling configuration (FIG. 22A).

“Position 2” as described attendant to the schematics200and230above is depicted atFIGS. 21A through 21C, representing a “closed” configuration as marked on the housing302. The cam370engages a second of the features388to secure the selector switch actuator360in position 2 (FIG. 21B). In the cross-section396b, the valve core368obstructs the conduit90, thereby blocking the conduit90to isolate the circuit110.

“Position 3” as described attendant to the schematics200and230above is depicted atFIGS. 22A through 22C, representing a “closed” configuration as marked on the housing302. The cam370engages a third of the features388as well as one of the stop features382to secure the selector switch actuator360in position 3 (FIG. 22B). In the cross section396c, the valve core368either obstructs or enables flow through the conduit90(FIG. 20C), depending on whether the optional flow orifice382′ is present. That is, for isolation valve96b, with two flow orifices382and382′, flow is enabled inFIG. 22C. For isolation valve96e, with only one flow orifice382, flow is blocked inFIG. 22C. Operation of isolation valve96cis reversed from that of isolation valve96b(i.e., being in an isolation configuration at position 1 and in a flow enabling configuration at position 3).

In this way, the switch actuator360cooperates with the selector switch body386and the features388,392of the manifold48c,48dto provide the three-position valves206of the manifolds48cand48d.

Referring toFIGS. 23 through 26, the layout and structure of the manifold48adepicting various aspects of the schematic180in the physical realm is presented according to an embodiment of the disclosure. A solid model representation420of the conduits90through the manifold48ais depicted atFIG. 23. The routing of the conduits through the housing302is depicted with hidden lines inFIG. 24. In the views ofFIGS. 23 and 24, the conduits90of manifold48aresemble the letter W, with the three input ports102,104, and106being at the top of the W and the output ports94being at the apexes at the bottom of the W. The manifold48ais depicted in isolation (with fittings) atFIG. 25and in installation inFIG. 26. Also, inFIGS. 24 through 26, the valve actuators338are identified individually as valve actuators338athrough338d, along with the corresponding isolation valve96athrough96d.

Referring toFIGS. 27 through 29, the layout and structure of the manifold48bdepicting various aspects of the schematic200in the physical realm is presented according to an embodiment of the disclosure. A solid model representation440of the conduits90through the manifold48bis depicted atFIG. 27. The routing of the conduits through the housing302is depicted with hidden lines inFIG. 28. The manifold48bis depicted in isolation inFIG. 29. In the depicted embodiment, the manifolds48a,48binclude a matrix structure424through which the conduits90pass and which supports the valves96. The bulkhead332, conduits90, and matrix structure424may be unitary. Also, inFIGS. 28 and 29, the valve actuators338are identified individually as valve actuators338athrough338e, along with the corresponding isolation valve96athrough96e.

For the manifolds48aand48b, the conduits90, and in particular the working channel conduits90aand90dof the main working channel circuit112and the auxiliary working channel circuit116, are characterized by gradual inflections. The conduits90also pass through the bulkhead332. Functionally, the gradual inflections of the main working channel conduit90aof the main working channel circuit112and of the auxiliary working channel conduit90dof the auxiliary working channel circuit116prevent crimping of working devices148, enabling smooth insertion. The lack of sharp corners for the irrigation conduits90band90creduces pressure losses through the irrigation circuits114and118. The matrix structure424provides the manifold48with ample strength and mounting features, and is amenable to a three-dimensional printing manufacturing technique.

Referring toFIGS. 30 through 32, the layout and structure of the manifold48ddepicting various aspects of the schematic230in the physical realm is presented according to an embodiment of the disclosure. A sectional view460of the conduits90b,90c, and90eas they are routed through the three-position selector switch394are depicted atFIG. 30. The routing of the conduits90through the housing302is depicted with hidden lines inFIG. 31. The manifold48dis depicted in isolation inFIG. 32. The manifold48dalso includes the matrix structure424through which the conduits90pass and which supports the valves96. The bulkhead332, conduits90, and matrix structure424may be unitary.

The main working channel142defines an inner diameter462and an outer diameter464(FIG. 30A). Likewise, the auxiliary working channel144defines an inner diameter466and an outer diameter468. In some embodiments, one of the working channels144,142defines a larger inner diameter466than the inner diameter462of the other of the working channels142,144. In the depicted embodiment, the auxiliary working channel144defines the larger inner diameter466and the main working channel142defines the smaller inner diameter462. However, this arrangement may be reversed, or negated by defining inner diameters462,466that are of substantially equal size. In some embodiments, the inner diameter466is within a range of 1.0 millimeters to 1.4 millimeters inclusive. In some embodiments, the inner diameter462is within a range of 0.6 millimeters to 0.8 millimeters inclusive. The respective outer diameters may accommodate a wall thickness within a range of 0.08 millimeters to 0.1 millimeters inclusive. This arrangement, while depicted for the manifold48d, may be implemented for any of the disclosed manifolds48.

The main working channel conduit90aof the main working channel circuit112and the auxiliary working channel conduit90dof the auxiliary working channel circuit116bypass the three-position selector switch394(FIG. 32). The manifold48cis similar to manifold48d, except that manifold48cincludes isolation valves96aand96don the main working channel input port102and the auxiliary working channel input port106.

Referring toFIGS. 33 through 38A, the layout and structure of the manifold48eas embodied atFIG. 14and depicting various aspects of the schematic240in the physical realm is presented according to an embodiment of the disclosure. The manifold48eincludes many of the same components and attributes as manifold48d, which are identified with same-numbered reference characters. Instead of the selector switch202or rotating two-position valve actuators338with rotating lever actuators346, the manifold48eincludes a plurality of two-position valves342having two-position (push/pull) translating valve actuators340. The two-position valves342are sliding valves472that, in some embodiments, isolate the respective circuit110when the translating valve actuator340is pulled outward (away from the manifold48e) and enables the respective flow circuit110when the translating valve actuator340is pushed inward (toward the manifold48e). In some embodiments, the push/pull action of the sliding valves472may be reversed; that is, the sliding valves472may be configured to enable flow by pulling on the translating valve actuators340and to isolate flow by pushing on the translating valve actuators340.

Each ofFIGS. 34 through 38depict the translating valve actuators340in a combination that configures the manifold48efor one or more of the configurations of Table 5. Each of theFIGS. 34A through 38Ais a sectional view of the manifold48eof the correspondingFIG. 34 through 38. The sectional views depict the conduits90and the sliding valves472. With respect to Table 5,FIGS. 34 and 34AandFIGS. 35 and 35Adepict the “Irrigation-Only” combinations for configurations (1) and (2);FIGS. 36 and 36Adepict the “Aspiration-Only” combination for configurations (3) and (4);FIGS. 37 and 37Adepict the “Irrigation+Aspiration” combination for configurations (5) and (6); andFIGS. 38 and 38Adepict the “Transition” and “Closed” combination for configurations (7) and (8).

Functionally, utilizing the plurality of two-position valves342instead of the selector switch202provides the operator with more combinations for operation. An example is the “Aspiration Only” configuration, which is not a configuration of the selector switch202as depicted herein. The larger and smaller inner diameters466,462provides one of the working channels144(depicted) or142with larger diameter throughput that extends through the lumens140of the catheter44. For a given cross-sectional area of the catheter shaft66, the allocation of the larger inner diameter466and the smaller inner diameter462can provide larger clearance in one of the working channels142,144than would be available if both inner diameters462and466were of equal dimension. The larger inner diameter466can provide greater clearance between or at least less interference between the working device148and the lumen140, for easier insertion of the working device148. The larger clearance also enables better flow within the annulus defined between the working device148and the wall of the lumen140. Furthermore, where the larger inner diameter462is utilized in the aspiration circuit116, the catheter44is 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.

The following references are hereby incorporated by reference herein in their entirety except for patent claims and express definitions contained therein: U.S. Provisional Patent Application No. 62/868,105, filed Jun. 28, 2019 and owned by the assignee of the present application; International Patent Application entitled “Efficient Multi-Functional Endoscopic Instrument” to Altshuler et al., filed on even date and owned by the owner of the present application; International Application No. PCT/US19/42491 to Altshuler, et al., filed Jul. 18, 2019 and owned by the owner of the present application; U.S. Pat. No. 9,775,675 to Irby, III. Any incorporation by reference of documents herein is limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein.

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 or spirit 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.