SINGLE USE URETEROSCOPE WITH INTEGRATED SUCTION CATHETER

A multi-channel endoscope can include a control section and an insertion end. The endoscope can include a user control mechanism. The control section can include at least one working channel and a channel within the control section. The working channel can accommodate at least one medical instrument which can fracture a target object into fragments. A catheter, such as a fluidic catheter, can extend from and retract to an originating proximal position at the insertion end of the endoscope. A vacuum pressure source or an irrigation source can be coupled to a proximal end of the channel. The user control mechanism can control the position of the catheter with respect to the endoscope and can be used to operate the vacuum pressure source or irrigation source.

BACKGROUND

A surgical device can provide access to surgical sites in a human body through a body opening, cavity, or tract. In certain urological procedures an opening can be dilated to accommodate one of several other medical devices. Instrumentation can be used such as to help mitigate the presence of stones (calculi) in the urinary tract. Endoscopic or ureteroscopic devices can have an articulation component, which allows the user to view, modify, repair, or otherwise interact with cavities and lumens within a human body. In some situations, a medical professional needs to remove fluid or other debris such as kidney stone fragments during procedures in which an endoscope or ureteroscope is used. For example, during a lithotripsy procedure, kidney stones may be broken down to small fragments and then the small fragments need to be removed from the ureter. In some cases, suction can be applied within the ureter to remove the kidney stone fragments. In another example, a flexible fiber with a basket-like component can be inserted into the ureter. The basket-like component can be used to grasp the kidney stone or kidney stone fragments and then remove the kidney stone or kidney stone fragments from the body. In another example, a small incision can be made in a body near the kidney and instruments can be inserted in the incision and then kidney. In this example, the medical professional can then remove the kidney stone or fragments of a kidney stone with a suction mechanism or other implements.

SUMMARY

A multi-channel endoscope or ureteroscope can have a control section and an insertion section. The insertion section can have an insertion end with multiple openings where the multiple openings can correspond to at least one of a working channel, optical systems, fluid systems (such as air systems or water systems), or suction and removal systems. The multi-channel endoscope can include a user control mechanism and/or an actuator. In an example, the user control mechanism can operate the insertion section so it can articulate to reach a target location. A need has been identified to have a suction mechanism in at least one of the channels of the multi-channel endoscope such as a first suction channel which can be operated simultaneously or concurrently while other medical instruments are operated from within at least one separate working channel. A suction catheter can be disposed within a working channel and at least one medical instrument can be operated in a separate working channel. The suction catheter can be integrated with the insertion end and can extend and retract from an originating proximal position at an insertion end of an insertion section of the endoscope. A vacuum pressure source can be coupled to a proximal end of the suction channel proximate to the control section. The user control mechanism can control the position of the suction catheter and also simultaneously or sequentially activate the vacuum pressure source so the vacuum may be applied to a target site. In an embodiment, the fluid systems deliver irrigation to the surgical site via an irrigation channel. The irrigation channel may be the same or different from the working channel used for providing suction or the working channel which provides an area for the medical instrument(s) to be inserted therein. Additionally or alternatively, an irrigation catheter may be included in an irrigation channel; the irrigation catheter can be integrated with the insertion end and can extend and retract from an originating proximal position at an insertion end of an insertion section of the endoscope.

DETAILED DESCRIPTION

An endoscope can be used to help facilitate access, visualization, or for manipulation of instrumentation during a procedure, such as which can be used to break up and remove one or more stones from the urinary tract. The endoscope can be at least partially inserted into an opening of a body of a patient or subject, such as for a urological procedure. In various examples, the endoscope can be partially inserted into any tract within a human body, such as to help remove small pieces of biological material.

For example, an endoscope can be used for visualization of an internal area of a tract within a patient, such as at an internal location where a procedure can be performed. The endoscope can include or be coupled to a camera component. The camera can transmit video or still pictures to a display screen locally or remotely located external to the patient. The endoscope can include or be coupled to a light source component, such as to provide light (e.g., via an optical fiber) at the internal location of the body for the camera to transmit visible images of the internal location. The endoscope can also have one or more channels or passages, e.g., working channels, through which one or more other instruments can pass.

For example, the endoscope can be a multi-channel endoscope. The multi-channel endoscope can include one or more working channels. Such a working channel can enable a user to pass and/or use one or more instruments during a procedure (such as one or more of a guidewire, a dilator, a basket, a laser fiber, a lithotripter, or one or more other instruments). For endoscopy in the urinary tract, the endoscope can be a ureteroscope. The ureteroscope can be flexible or otherwise specialized for use in the upper urinary tract. A challenge of using such a multi-channel ureteroscope or other endoscope is it can lack concurrent, simultaneous, or real-time suction or irrigation during certain urological procedures.

The present inventors have recognized, among other things, that an endoscope enabling concurrent or real-time fluidic action, such as suction or irrigation, during a urological procedure can be used such as to help remove stones or stone fragments, dust, or other target bodies. Devices and systems disclosed in this document can help reduce a need to break the stones into small enough fragments during the procedure such as to permit natural expulsion from the body—which can be a challenge of using an endoscope without integrated or suction capabilities. The devices and systems disclosed herein can help ease and speed the procedure such that a patient is substantially unencumbered of stones immediately following the procedure.

FIG.1illustrates an example of a multi-channel endoscope100(“endoscope”) such as a ureteroscope that can be used for urological treatments. The endoscope100can include a control section102, an insertion section104, and a connector section106.

The control section102can be an intermediary section between the connector section106and the insertion section104. The control section102can be the primary user interface of the endoscope100. The control section102can include at least one component for operating components within or associated with the endoscope100, such as a user control mechanism140or an actuator142.

The user control mechanism140can be used to guide or control mechanical movements of the insertion section104of the endoscope100. The user control mechanism140can include at least one of a button, lever, joystick, knob, dial, touch sensor, or the like. There can be more than one user control mechanism140included in or coupled to the control section102. The control section102can also include a handle110, or grip. A medical professional or other user can hold the handle110with one hand while operating the user control mechanism140with the other hand.

The actuator142can be included with or coupled to the control section102at a location remote from or proximate to the user control mechanism140. The actuator142can include at least one actuator, such as one or more of a button, lever, joystick, knob, dial, touch sensor, or the like. The actuator142can control one or more mechanical or electrical components, such as those mechanical or electrical components that can be located within or associated with the control section102and can extend through the insertion section104. In an example, there can be more than one actuator. For example, a first actuator can be couplable with a medical instrument and a second actuator can be couplable with a suction component.

The insertion section104can house mechanical or electrical components which can extend from at least the control section102through a lumen120of the insertion section104. The lumen120can terminate at an insertion end150. The insertion end150can have at least one openings corresponding to at least one channel.

The mechanical or electrical components within the endoscope100can also be housed within and extend through a universal cord130. The universal cord130can be on an opposite end, or remotely located, from the insertion section104. The universal cord130can couple any of a plurality of external systems180to the insertion section104, as will be discussed further below.

FIG.2illustrates a view of the internal components of the control section102of the endoscope100. The control section102can include one or more electronic components240such as wires, electronic cables such as fiber optic cables, electronic circuitry chips, computer hardware, or the like. In an example, the one or more electronic components240can transmit one or more wired or wireless electrical signals, such as to or from the insertion end150of the insertion section104and from or to the connector section106or the control section102, such as discussed further below. For example, the one or more electronic components240can communicate one or more imaging signals or light signals to or from at least one component at the insertion end150.

In an example, the control section102can also include one or more operation connections245. The one or more operations connections245can connect at least one suction component246or at least one fluid transfer component247, such as via a lumen120in the insertion section104that is in fluid communication with the insertion end150. The one or more operation connections245can further connect the at least one suction component246, such as a suction valve, or the at least one fluid transfer component247(such as an air source line or an irrigation fluid supply line) with the connector section106. The suction channel250and/or the at least one fluid transfer component247can include respective tubes that can allow fluid, such as air or liquid, or small solid particles such as debris, or biological remains acquired from within the patient, to pass through.

The control section102can also include at least one working channel220through which a surgical tool or other implement can be passed. For example, the at least one working channel220can provide a guidewire lumen passageway that is sized for permitting a guidewire230to pass. The guidewire230can be used to help provide for better navigation of the lumen120toward, to, or within the target location. The guidewire230can also allow for advancement of one or more of a dilator, a stent, a catheter, a target object (e.g., stone) removal implement, a drainage implement, or the like. The at least one suction component246can pass through the suction channel250. In an example, the at least one suction component246can include a suction catheter255, as described later.

FIG.3shows an example of the control section102and the insertion section104. The insertion section104can include the lumen120. The insertion section104and the associated lumen120can be located at or proximate to a distal end112of the handle110of the control section102and coupled with a proximal end114of the insertion end150. The insertion section104providing the lumen120can include a medical grade tube that can be sized and shaped to traverse one or more passages within the patient to a target location, such as within the urological anatomy of a patient. The insertion section104providing the lumen120can be made from a flexible material. This can allow the insertion section104providing the lumen120to more easily traverse passages within the body.

FIG.4shows an example in which the insertion end150can be located at the distal end122of the insertion section104. The insertion end150can be sized and shaped to fit within a desired passage in the body, such as to be operable at and proximate to the target location. The insertion end150can include at least one of the following components: at least one optical component340such as at least one optical fiber bundle or other light guide342, at least one video or photographic component344or optical coupler thereto, at least one fluid outlet360, and at least one working channel220, such as discussed in more detail below.

FIG.5shows an example in which the connector section106can connect the endoscope100with at least one external component or system180. The connector section106can act as an interface conduit for the endoscope100to connect to one or more external components or systems180. A universal cord130can be sized such that wires, cables, or tubes can pass through or traverse from the connector section106to the control section102. The at least one external component or system180can include a light source, a video or photo interface or system, a fluid supply (such as an air supply or a water supply), a suction system, or the like.

For endoscopy in a urinary tract, as illustrated inFIG.4, the flexibility of the lumen120can allow the lumen120to articulate or move within the tract. The lumen120can articulate upward, downward, right, left, or a combination of directions such as to permit the insertion end150to move or be placed at a target location. The lumen120of the insertion section104can include at least one mechanical system210such as a linkage member that can couple the user control mechanism140with a distal end122of the lumen120. For example, a linkage member210can include one or more cables, wires, or other linkage members, such as can be associated with at least one rotating reel (or rotatable member)141internal the handle110, as illustrated inFIG.2. The at least one rotating reel141can maneuver, for example, the linkage member210to controllably couple the user control mechanism140and the distal end122of the lumen120. For example, at least one mechanical system can be a first cable210acan articulate the lumen120in a vertical direction. A second cable210bcan articulate the lumen120in a horizontal direction.

The first cable210acan be connected with a first user control mechanism140awhich can be disposed externally on the handle110. The second cable210bcan be connected with a second user control mechanism140bwhich can be disposed externally on the handle110. The first user control mechanism140aand the second user control mechanism140bcan include respective rotatable components such as knobs, gears, handles, or the like. The first user control mechanism140acan be stacked or share a common axis of rotation with the second user control mechanism140b. In another example, the first user control mechanism140acan be separately located from the second user control mechanism140b. The first user control mechanism140aand the second user control mechanism140bcan be coupled to any electromechanical system or other mechanism that can cause articulation of the insertion section104providing the lumen120.

Within the lumen120extending along the insertion section104there can be one or more components or systems that can extend from the control section102to the distal end122or the insertion end150. The insertion end150of the lumen120can house one or more individual components that can communicate with the one or more systems or components within the control section102or the connector section106. Systems within the lumen120can include a fluid system347(such as an air or irrigation fluid delivery system), the suction channel250, the at least one mechanical system210(such as to articulate the insertion section104providing the lumen120), or at least one optical component340(such as a camera, a light source, fiber bundle or other illumination component).

The insertion section104can include at least one working channel220. The at least one working channel220can be used to pass and use one or more instruments during a procedure (such as a guidewire, a dilator, a basket, a laser fiber, a lithotripter, or a combination of these or one or more other instruments). The at least one working channel220can be separate from the fluid system347, the suction channel250, the at least one mechanical system210, and the at least one optical component340. The instruments that can pass through the at least one working channel220can include one or more instruments that can be operated sequentially or substantially simultaneously, concurrently or separately. For example, a laser fiber222can be introduced through at least one working channel220such that the laser fiber222can be used to deliver laser energy pulses to help break down one or more desired target objects.

The suction channel250can carry a catheter255, such as a suction catheter. The suction channel250can house or contain the suction catheter255such that the suction catheter255can be introduced via the suction channel250. The suction catheter255can be integrated with the suction channel250.

FIGS.6A and6Bshow an example in which the suction catheter255can include an extendible portion320. The extendible portion320can be selectively operated to extend or retract from the suction channel250. As illustrated inFIG.6B, the suction catheter255is illustrated in a retracted state, such that it can be housed or contained within the insertion end150. In the retracted state, an end of the suction catheter255can be in a position that the suction catheter255does not protrude, or only minimally protrudes, beyond the insertion end150.

The suction catheter255can be fully or partially extendible. In a partially extendible configuration, as illustrated inFIG.6A, at least a portion of the extendible portion320of the suction catheter255can extend beyond the insertion end150. In a fully extendible configuration, the extendible portion320of the suction catheter255is extended completely such that substantially all of the extendible portion can extend beyond the insertion end150.

The extendible portion320can extend substantially linearly320a, as illustrated inFIG.7Bor in an arcuate manner320b, such as illustratedFIG.7C. The extendible portion320can be retracted such that the extendible portion320can be housed within the lumen120when not deployed, such as illustrated inFIG.6B. The extendible portion320can be housed or contained within the insertion end150when the extendible portion320is not in use. The extendible portion320of the suction catheter255can be completely or mostly within the insertion end150proximal of the distal-most portion of the insertion end150. For example, when the extendible portion320is in use, at least a portion of the suction catheter255can be extended from the distal-most end of the insertion end150and toward or to the target location.

FIGS.7A,7B and7Cshow examples in which the extendible portion320can include a shape memory extendible tube. The extendible portion320can be made from a plurality of shaft elements324that can be individually or collectively connected to the actuator142, or any other component which can cause the extendible portion to extend and articulate. The extendible portion320can include or be made from concentric tubes, such as to form a telescoping portion322. The actuator142can be operated to both extend or retract the telescoping portion322, such as by movably positioning any or all of the plurality of shaft elements324distally outward or proximally inward. The actuator142can include or use a cable, wire, an electromechanical element, pneumatic or hydraulic elements such as a solenoid, or a motor or micromotor connected or coupled to at least one of the plurality of shaft elements324.

In an example, a linkage can couple the actuator to an inner-most of a series of the concentric telescoping portion322which, at a proximal end, can include an outward radial flange. The outward radial flange can engage or couple with an inward radial flange of the next outward concentric shaft element. This arrangement can be repeated through each of the connected shaft elements324so a single or shared linkage can be used to form the telescoping portion322.

In an example, each of the connected shaft elements324can form a seal, or have a seal, between the adjacent, or next, shaft element324in the telescoping portion322. Each of the connected shaft elements324can also have a material disposed, formed, affixed or the like, to at least of one of a proximal or distal end of a shaft element324which can assist in forming a seal between the adjacent or next shaft element324. The seal can assist in the next outer shaft element324preservation of the suction and can inhibit escape or release of any applied vacuum from between the shaft elements324.

The extendible portion320can be coupled with the user control mechanism140. In another example, the extendible portion320can be coupled with the actuator142. The actuator142can be used to move the extendible portion320from a retracted position originating within the distal end152of the insertion end150to an extended position exposed outside of the distal end152and from the extended position to the retracted position. At least one cable330or wire or other mechanical or other linkage can be coupled with the actuator142and the extendible portion320. The at least one cable330can control the position of the extendible portion320, such as to position at or move between a retracted or extended position or to articulate the extendible portion320. The at least one cable330can apply tension or a tensile force to the lumen120.

The extendible portion320can include or be made from a shape memory material such as a shape memory alloy or a shape memory polymer. A hybrid of shape memory alloy and polymer can be used if desired. Examples of shape memory alloys can include copper-based alloys, iron-based alloys, or nickel-based alloys. Examples of shape memory polymers can include polyurethane based materials. In an example, Nitinol, a nickel-based shape memory alloy can be used.

The actuator142can operate at least one of articulation of the suction catheter255, extension and retraction of the suction catheter255, or activating or deactivating a vacuum pressure source380. The actuator142can include a button, lever, joystick, knob, dial or touch sensor, or any other mechanical or electrical device that can transmit an operating control force or signal to the suction catheter255. In an example, the actuator142can include a remote component that is not directly connected with the control section102. For example, the actuator142can have components on remote, but electronically connected, computer systems. The actuator142can control the position of at least a portion of the suction catheter255such that the distal or other desired portion of the suction catheter255can be moved toward or to the target site or area at which suction is to be applied to remove material from the target site and from the patient. In an example, the actuator142can extend at least a distal portion of the suction catheter255. In an example, the actuator142can extend the shaft elements324such that the shaft elements324of the suction catheter255extend past the insertion end150. The actuator142can communicate signals or mechanically retract the shaft elements324such that the shaft elements324are retracted into and housed within the suction channel250. For example, the actuator142can be coupled with a cable, wire, an electromechanical element, pneumatic or hydraulic elements such as a solenoid, or a motor or micromotor. In another example, the actuator142can deactivate the vacuum pressure source380to remove the material from the patient.

The actuator142can operate at least one operation of the suction catheter255. The actuator142can extend or retract the suction catheter255. The actuator142can activate or deactivate a vacuum pressure source380. The actuator142can control the articulation of the suction catheter255. In an example, the actuator142can have separate components each of which controls one of articulation of the suction catheter255, extension and retraction of the suction catheter255, or activating or deactivating a vacuum pressure source380. The actuator142can operate the suction valve or other component which can actuate a system to supply a vacuum flow through the suction catheter255.

In an example, the proximal end of the suction channel250can be coupled with the vacuum pressure source380within the control section102, within the proximal portion121of the lumen120, or at any location within or remote to the endoscope100. The vacuum pressure source380can be coupled with the connector section106. The universal cord130can couple the vacuum pressure source with the control section102and the suction channel250. The suction catheter255can be disposed within the suction channel250such that the vacuum pressure can be transmitted to and through the suction catheter255.

FIGS.8A and8Billustrate an example of an insertion end150of a multi-channel endoscope100in which one of the working channels220can be a fluidic channel860. The fluidic channel860can be a channel configured to receive or house a fluidic catheter865such as an irrigation catheter or a suction catheter. The fluidic catheter865can apply a fluid, such as a low-pressure vacuum or an irrigation liquid (e.g. water, saline, medication, or the like) to the target site. The fluidic channel860can be a separate channel from the previously discussed suction channel and can be configured to receive or house the fluidic catheter865as an irrigation catheter867. In an example in which the fluidic channel860includes the irrigation catheter867, the irrigation catheter867can articulate and extend similar to the suction catheter255discussed above. The irrigation catheter867can be controlled by an irrigation actuator842, which can be the same actuator as an actuator for a suction catheter or it can be a separate actuator. In an example in which the irrigation actuator842illustrated inFIG.3is a separate actuator, the irrigation actuator842can control the extension of the irrigation catheter867from an originating position, as illustrated inFIG.8A, to an extended (partially extended or fully extended) position, as illustrated inFIG.8B. The irrigation catheter867in an originating position can be oriented so it does not protrude or extend past the end of the insertion end150. The irrigation catheter867, in an extended position, can extend to the target site. The irrigation catheter867can operate concurrently, simultaneously, or separately from a suction catheter or other components extending within the multi-channel endoscope.

As illustrated and described inFIG.9, the method400, below, the catheter255, such as a fluidic catheter, suction catheter, or irrigation catheter, can be a component within the multi-channel endoscope and can be used to assist in the removal of one or more target objects from a patient's body. The target objects to be removed can include fragments of stones or calculus within a kidney or the urinary tract.

At410, at least one target object can be identified to be removed from a body with a multi-channel endoscope. A medical professional or other user can use the endoscope or another instrument to identify the location of the target object to be removed. Such methods can be by ultrasound, x-ray, or the like. After locating the target object, the following acts can be performed to remove the target object and to treat the patient.

At420, the insertion section104can be inserted into an opening in a human body, such as an incision or the urethra. The insertion section104can pass through the bladder and ureter to the kidney or other target location. The insertion section104can include multiple channels, such as multiple working channels.

At430, upon approaching the target location, the at least one working channel can be configured to accommodate or receive at least one medical instrument. The at least one medical instrument can pass from the control section, or handle, to the distal end of the insertion section104. At least one of working channel, or a separate working channel can be configured to be a suction channel that can house a suction catheter. The suction catheter can extend from the control section, or handle, to a distal end of the insertion section. A medical instrument can be passed through the at least one working channel. The medical instrument can be selected for use to treat the target object.

At440, a treatment actuator can be used to treat the target object by fracturing or breaking the target object into smaller pieces. The smaller pieces can be sized to fit within and removed by the suction catheter. In an example, a laser fiber can be passed through the at least one working channel and used to deliver one or more laser pulses to help break down the target object.

At450, the actuator can be operated to extend, or articulate, the suction catheter away from the distal end of the insertion end. The user can operate a second actuator to extend or articulate the suction catheter away from the originating location within the distal end of the insertion end. The user can extend the suction catheter until a distal end of the suction catheter can be placed proximate to the target object. The user can operate the actuator such that the suction catheter can be extended from the insertion end to the target location. The actuator can extend individual sections of telescoping portions of the suction catheter. The actuator can extend multiple or all of the telescoping sections sequentially, concurrently, or simultaneously.

The user can operate the actuator to articulate the suction catheter. The user can also operate a second actuator to articulate the suction catheter. The user can operate the actuator or the second actuator to move the suction catheter upward, downward, right, left or a combination thereof.

At460, the user can then operate the vacuum pressure source to draw the fragments of the target object into the suction catheter. The suction catheter can be operated independently, sequentially or substantially simultaneously with the medical instrument. For example, breaking up the target object can be performed independently of drawing the fragments of the target object into the suction catheter. In this example, the user can use the suction catheter during a procedure without the user needing to remove a medical instrument from the at least one working channel or without needing to remove the endoscope from the patient's body.

At470, after drawing in or removing substantially all, or all, of the target object fragments the user can withdraw or retract the suction catheter into the suction channel of the insertion end of the insertion section. The user can then pass any further medical instruments through the at least one working channel, such as a separate working channel from the suction channel, to take any further steps in the medical procedure.

At480, the user can withdraw the insertion section from the patient's body.

The above description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “aspects” or “examples.” Such aspects or example can include elements in addition to those shown or described. However, the present inventors also contemplate aspects or examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate aspects or examples using any combination or permutation of those elements shown or described (or one or more features thereof), either with respect to a particular aspects or examples (or one or more features thereof), or with respect to other Aspects (or one or more features thereof) shown or described herein.