Patent Description:
The present invention relates to systems and exemplary methods for the guided removal of objects in vivo. In particular, the invention is directed to a removal device adapted to traverse compact areas utilizing a navigation mechanism, and more specifically, to capture and/or remove debris through a vacuum tube that is in communication with a suction source.

Kidney stones are a common medical problem that negatively impact millions of individuals worldwide. Kidney stones include one or more solid masses of material that are usually made of crystals and form in parts of the urinary tract including in the ureter, the kidney, and/or the bladder of the individual. Kidney stones range in size from smaller (less than about <NUM>) to very large (more than <NUM>) and may cause significant pain to the individual and damage to the kidney. The overwhelming majority of stones that are treated by surgeons are less than <NUM>.

The recommended treatment for removal of the kidney stones varies according to numerous factors including the size of the kidney stones, the number of kidney stones, and the location of the kidney stones. The most common treatments for kidney stones are shock wave lithotripsy (ultrasound waves used to fracture the stones), ureteroscopy (fracture and removal of the stones using an endoscope that is introduced through the bladder), and percutaneous nephrolithotomy (fracture and removal of the stones using an endoscope that is introduced through a sheath placed through the patient's back into the kidney).

The largest kidney stones are usually removed through percutaneous nephrolithotomy or nephrolithotripsy, or through other similar procedures. In these procedures, a small incision is made through the patient's back adjacent the kidney and a sheath is passed into the kidney to accommodate a larger endoscope used to fracture and remove stones. The stone may be removed directly through the tube or may be broken up into small fragments while still in the patient's body and then removed via a vacuum or other known methods (nephrolithotripsy).

There are numerous drawbacks associated with nephrolithotomy, nephrolithotripsy, and other invasive surgeries requiring an incision in the skin. Namely, such surgical techniques may require significantly more anesthesia administered to the patient, the surgeries are more complicated and pose a higher risk of infection and complications for the patient, and the surgeries require a substantial incision in the patient, which may leave a scar. Additionally, given the invasiveness of the procedure, percutaneous procedures are usually not preferred for smaller kidney stones (e.g., less than <NUM>) depending on the size and location of the stones.

In contrast, traditionally, smaller kidney stones have been treated using other, less invasive techniques including through ureteroscopy. In ureteroscopy, the surgeon typically inserts a ureteroscope into the urethra through the bladder and the ureter to provide the surgeon with a direct visualization of the kidney stone(s) which may reside in the ureter or kidney. The surgeon then removes the kidney stone directly using a basketing device if the kidney stone is small enough to pass through the urinary tract without difficulty, or the surgeon fractures the kidney stone into smaller pieces using a laser or other breaking device. After breaking the kidney stone into smaller pieces, the surgeon removes the laser or breaking device and inserts a basket or other object to capture the kidney stone fragments. Upon retrieving some of the kidney stone fragments, the surgeon removes the basket from the patient and empties the kidney stone fragments therefrom. This process is repeated until all kidney stones and kidney stone fragments are broken up and removed from the body.

It should be apparent that this process is extremely time consuming, costly, and inefficient because the surgeon is required to insert and remove the scope and basket into and out of the patient many times to completely remove the kidney stones and kidney stone fragments therefrom. Using a basket removal device to capture kidney stones or kidney stone fragments suffers from other drawbacks in that the basket is difficult to position adjacent the kidney stone fragments and maneuver in a manner that effectively retrieves the fragments. The training required for such a procedure is not insignificant and the aforementioned basket removal technique is difficult for even the most skilled surgeons. Additionally, the surgeon is susceptible to hand fatigue due to the extended amount of time required to operate the kidney stone retrieval baskets. Further, the patient is required to be under local anesthesia and/or remain immobile over an extended amount of time. Still further, the basket retrieval devices cause irritation to the urinary tract due to the repeated insertion and removal therefrom. <CIT> discloses a known stone retrieval device in the field comprising an elongated member defining a suction passageway extending longitudinally there-through. <CIT> discloses another known device in the field, wherein a multi-size convertible catheter for use in biliary endoscopic procedures is disclosed.

Other kidney stone removal techniques may utilize suction devices to remove kidney stones and kidney stone fragments from the patient. Such techniques use a flexible tube designed to be disposed within a working channel of a ureteroscope. The flexible tube is designed to have a diameter of between <NUM> french and <NUM> french and includes a suction source therethrough. Utilization of this type of device necessarily restricts the size of the passageway available to remove kidney stones and portions thereof from the patient. Indeed, the diameter of the ureteroscope occupies a significant portion of the limited passageway into the patient. Therefore, the size of the flexible tube is bounded by the size of the working channel of the ureteroscope and is defined by a diameter of under about <NUM> french. The utilization of the working channel of a ureteroscope or other viewing instrument has heretofor been utilized to assist the surgeon in locating the matter to be removed from the patient and to assist in guiding the removal instruments to an appropriate location. The use of these devices is necessarily restricted to removal of debris that is smaller than the size of the tube disposed in the working channel (i.e., under about <NUM> french). Accordingly, the prior art devices of this type are unable to remove debris greater than about <NUM> and removal of even smaller stones becomes problematic given the narrow lumen size in the prior art devices and their resulting propensity to clog, even with stones of <NUM> or less.

The present invention overcomes the aforementioned drawbacks by providing a way to guide a removal device into position inside of a patient in a manner that does not necessarily require a viewing instrument. The elimination of the access approach using the working channel in the viewing device, as currently known in the art, provides numerous advantages over the prior art devices because it allows the removal device to have a larger diameter and is capable of removing kidney stone that are clinically significant (e.g., both small and larger kidney stones )and kidney stone fragments as a result thereof. Further advantages are realized through the use of a navigation mechanism that assists the surgeon in positioning the device without the use of a viewing instrument (although a viewing instrument or other viewing techniques could be used in conjunction with the device, if desired). The diameter parameter of the device is designed to allow removal of debris and kidney stones characterized as dust fragments to greater than about <NUM> in diameter.

In one configuration, a removal device includes vacuum tube adapted to be associated with a sheath sized to be inserted into a passageway of the subject. The vacuum tube provides a suction channel extending therethrough. A navigation mechanism is designed to guide the vacuum tube through the passageway. The removal device is designed to remove debris having an approximate diameter of between about <NUM> to about <NUM>.

In a different configuration, a removal device for use in a human urinary tract includes a sheath designed to be positioned in the urinary tract. A vacuum tube is disposed at least partially within the sheath, wherein the vacuum tube is characterized by a diameter of about <NUM> Fr. to about <NUM> Fr. A valve is in communication with a suction source, wherein the valve is adapted to regulate suction supplied to the vacuum tube.

In another configuration, a method, not forming part of the invention, of removing an object includes the steps of positioning a sheath in a passageway and inserting a device into the passageway adjacent the object to break the object into fragments. The method further includes the steps of removing the device from the passageway, guiding a vacuum tube through the sheath adjacent the fragments of the object, and applying a suction to remove the fragments of the object.

The foregoing and other aspects and advantages of the invention will appear from the following description. In the description, reference is made to the accompanying drawings which form a part hereof, and in which there is shown by way of illustration a preferred embodiment of the invention. Such embodiment does not necessarily represent the full scope of the invention, however, and reference is made therefore to the claims and herein for interpreting the scope of the invention as defined by the appended claims.

Referring generally to <FIG>, a removal device <NUM> includes a sheath <NUM>, a vacuum tube <NUM>, and a navigation mechanism <NUM>. The removal device <NUM> optionally includes an introducer core <NUM> adapted to assist in positioning one or more portions of the removal device <NUM> in a passageway. The removal device <NUM> further optionally includes a valve <NUM> that is in communication with, and assists in controlling suction that is supplied to the vacuum tube <NUM>. One or more of the sheath <NUM>, navigation mechanism <NUM>, and/or introducer core <NUM> may be optional for use with the removal device <NUM>. For example, in one configuraiton, the sheath <NUM> is omitted from the removal device <NUM>.

As best seen in <FIG> and <FIG>, the removal device <NUM> is designed to be positioned in a passageway of a patient (e.g., urinary tract), and in particular, into a patient's ureter <NUM>. The removal device <NUM> includes a renal end <NUM> designed to be positioned proximate the patient's kidney <NUM>, and more particularly, adjacent to one or more kidney stones <NUM>. The removal device <NUM> includes a bladder end <NUM> that is designed to extend through the bladder <NUM> and out of the patient through the urethra (not shown). The removal device <NUM> provides an uninterrupted passageway from the kidney stones <NUM> or kidney stone fragments in the kidney <NUM>, through the ureter <NUM> and bladder <NUM>, and out of the patient.

Now turning to <FIG>, the sheath <NUM> is provided as at least one substantially cylindrical tube <NUM> defining a lumen. The tube <NUM> includes at least one passageway <NUM> extending substantially longitudinally therethrough, although additional passageways may be included in the sheath <NUM> as desired. The passageway <NUM> extends through the entirety of the sheath <NUM> and is adapted to receive a ureterscope <NUM> (see <FIG>) and/or other viewing instrument. The ureterscope <NUM> preferably includes a laser (not shown) or other mechanism that fractures the kidney stone <NUM> into smaller fragments (or dust). The passageway <NUM> is also designed to accommodate the vacuum tube <NUM> and/or navigation mechanism <NUM> therein, as described in more detail hereinbelow. The tube <NUM> is preferably substantially cylindrical to conform to the orifice and/or passageway of the patient in which the removal device <NUM> is designed to be utilized. In other configurations, the tube <NUM> includes other shapes as desired. It should also be noted that the sheath <NUM> may be omitted from the removal device <NUM> all together such that the vacuum tube <NUM> is utilized and serves the function of the sheath <NUM>, which is discussed hereinbelow.

The sheath <NUM> is preferably made of a biocompatible material that is rigid enough to support the other components of the removal device <NUM> (e.g., the vacuum tube <NUM> and navigation mechanism <NUM>), but elastic enough to conform to the contours of the passageway of the patient. For example, suitable materials for use as the sheath <NUM> include polymers and copolymers such as polyurethane, polyvinyl chloride, polyethylene, polypropylene, and polyamides. Other useful materials include other biocompatible plastics, e.g., polyester, nylon based biocompatible polymers, polytetrafluoroethylene polymers, silicone polymers, and other thermoplastic polymers.

The sheath <NUM> is preferably defined by a length dimension of about <NUM> to about <NUM>. In a different configuration, the sheath <NUM> includes a length dimension of about <NUM> to about <NUM>. In a further configuration, the sheath <NUM> has a length dimension of about <NUM> to about <NUM>. It should be apparent that the length of the sheath <NUM> may be adjusted in view of numerous factors including, for example, patient size.

The sheath <NUM> is further defined by an interior diameter dimension of the tube <NUM>. In one configuration, the interior diameter of the tube <NUM> is between about <NUM> Fr. to about <NUM> Fr. In a different configuration, the interior diameter of the tube <NUM> is between about <NUM> Fr. to about <NUM> Fr. In another configuration, the interior diameter is between about <NUM> Fr. to about <NUM> Fr.

Now turning to <FIG> and <FIG>, the vacuum tube <NUM> is characterized by an elongate dual lumen <NUM> defined by a first (larger) passageway <NUM> and a second (smaller) passageway <NUM> extending longitudinally therethrough. The vacuum tube <NUM> may optionally include a specialized tip (not shown) at an end thereof that assists in maintaining the patency of the vacuum tube <NUM>. The tip may also allow the vacuum tube <NUM> to be positioned in areas that are difficult to access (e.g., the lowest part of the kidney).

The first passageway <NUM> is designed to accommodate the introducer <NUM>, which is used to assist in positioning one or more portions of the removal device <NUM> in the patient, as explained in more detail hereinbelow. The first passageway <NUM> is also designed to accommodate the suction provided from a suction source <NUM> (see <FIG>) that is utilized with the removal device <NUM>. The first passageway <NUM> of the vacuum tube <NUM> guides the suction to an area adjacent the kidney stones <NUM> (and/or kidney stone fragments) and facilitates the kidney stones <NUM> being removed therethrough. The first passageway <NUM> acts as a primary passageway for removal of the kidney stones <NUM> (and/or kidney stone fragments).

Still referring to <FIG> and <FIG>, the second passageway <NUM> of the vacuum tube <NUM> is disposed adjacent an internal surface <NUM> of the lumen <NUM> and is designed to accommodate the navigation mechanism <NUM> as shown in <FIG>. In a different configuration, the second passageway <NUM> may also accommodate a ureterscope or other viewing instrument. In still a further configuration, the second passageway <NUM> may accommodate other devices that may be utilized in conjunction with the removal device. For example, in one particular configuration, a miniature camera, ureteroscope, or other visualization device may be utilized through either the first or second passageway <NUM>, <NUM>. Although depicted adjacent the internal surface <NUM>, the second passageway <NUM> may be disposed in any other location within the vacuum tube <NUM>, or may be omitted all together. Further, the size of the first and second passageways <NUM>, <NUM> may be adjusted as desired.

In a different configuration, the removal device <NUM> and/or vacuum tube <NUM> includes additional lumens extending therethrough. For example, in one configuration, the removal device <NUM> includes a first passageway adapted to receive a suction source, a second passageway adapted to receive a camera or other visual aid, and a third passageway adapted to receive a guidewire.

The vacuum tube <NUM> is preferably made of a flexible biocompatible material such that the vacuum tube <NUM> is able to move through the contours of the passageway of the patient The vacuum tube <NUM> is preferably made of a material that is not susceptible to kinks and knots during insertion, use, and removal. For example, in some configurations, the vacuum tube <NUM> is constructed of a thermoplastic elastomer, or a natural or synthetic polymer such as silicone. In other configurations, suitable materials for use include other polymers and copolymers such as polyurethane, polyvinyl chloride, polyethylene, polypropylene, and polyamides. Other useful materials include other biocompatible plastics, e.g., polyester, nylon based biocompatible polymers, polytetrafluoroethylene polymers, silicone polymers, and other thermoplastic polymers.

One or more portions of the vacuum tube <NUM> may include a coating and/or may comprise a hydrophilic or hydrophobic material. The coating may assist in positioning the vacuum tube <NUM> within the sheath <NUM>, positioning the navigation mechanism <NUM> within the vacuum tube <NUM>, and/or assisting in debris removal through the first passageway <NUM>.

The vacuum tube <NUM> may also include a reinforcement mechanism (not shown) along a portion (or all) thereof that assists in maintaining the patency and the flexibility thereof. In one configuration, the reinforcement mechanism is provided in the form of a spiral or non-spiral wire. In a different configuration, the reinforcement mechanism is provided in other forms as known in the art.

In one configuration, the vacuum tube <NUM> includes a hydrophilic or hydrophobic coating and the vacuum tube <NUM> is used without the sheath <NUM>. In a different configuration, the vacuum tube <NUM> is designed to be disposed at least partially within the sheath <NUM> during use. Therfore, the circumference of the vacuum tube <NUM> is smaller than that of the sheath <NUM>. The lumen <NUM> of the vacuum tube <NUM> is defined by a diameter of between about <NUM> Fr. to about <NUM> Fr. , more preferably between about <NUM> Fr. to about <NUM> Fr. , and most preferably between about <NUM> Fr. to about <NUM> Fr. In one configuration, the lumen <NUM> of the vacuum tube <NUM> is about <NUM> Fr. In a different configuration, the lumen <NUM> of the vacuum tube <NUM> is about <NUM> Fr. In still a different configuration, the lumen <NUM> of the vacuum tube <NUM> is about <NUM> Fr.

The diameter of the second passageway <NUM> of the vacuum tube <NUM> is smaller than the diameter of the lumen <NUM> and is characterized by a diameter of between about <NUM> Fr. to about <NUM> Fr. , and more preferably between about <NUM> Fr. to about <NUM> Fr. In one configuration, the second passageway <NUM> of the vacuum tube <NUM> is about <NUM> Fr. In a different configuration, the second passageway <NUM> of the vacuum tube <NUM> is about <NUM> Fr. In still a different configuration, the first passageway <NUM> of the vacuum tube <NUM> is about <NUM> Fr.

Still referring to <FIG>, as discussed previously, the second passageway <NUM> of the vacuum tube <NUM> is designed to accommodate the navigation mechanism <NUM> as shown in <FIG>. The navigation mechanism <NUM> is preferably provided in the form of a guidewire. Guidewires suitable for use in the removal device <NUM> are characterized by a diameter of between about <NUM> in. to about <NUM> in. In one configuration, the guidewire is characterized by an elongate flexible material having a diameter of about <NUM> in. or about <NUM> in. Guidewires suitable for use with the removal device <NUM> include, for example, the Sensor™ guidewire provided by Boston Scientific (Natick, MA), or the Glidewire™ provided by Terumo International Systems (Tokyo, Japan). Additionally, the removal device <NUM> may be utilized in conjunction with the guidewire described in <CIT>. In other configurations, the navigation mechanism <NUM> may comprise other devices or mechanisms that assist in positioning portions of the removal device <NUM>.

The vacuum tube <NUM> and/or other portions of the removal device <NUM> may be controlled using various control mechanisms. For example, in one configuration, the vacuum tube <NUM> is controlled using a knob, a lever, a button, a foot pedal, combinations thereof, and the like. Various operational parameters may be controlled with the aforementioned control mechanisms including positioning and/or navigating one or more components of the vacuum tube <NUM>, and/or controlling (e.g., increasing or decreasing) the level of suction.

In one configuration, the guidewire is designed to be inserted into the patient and navigated to the kidney <NUM>. The removal device <NUM> is passed over the guidewire through one of the passageways described herein (e.g., the second passageway <NUM>). In some instances, the sheath <NUM> is optionally inserted into the patient first, followed by one or more of the guidewire and/or removal device <NUM>.

In a different configuration, the removal device <NUM> is designed to interact with and pass over the guidewire. In one configuration, the guidewire is inserted into the sheath <NUM>. In a different configuration, the guidewire is inserted into a portion of the vacuum tube <NUM> (e.g., through the first or second passageway <NUM>, <NUM>, respectively). The guidewire may be utilized in one or more of the passageways in the removal device <NUM>. In a preferred configuration, the guidewire is initially inserted into the flexible tube <NUM> of the sheath <NUM> in conjunction with the ureterscope <NUM>. The guidewire is also preferably utilized in conjunction with the second passageway <NUM> as a guidance mechanism for the vacuum tube <NUM> as described in more detail hereinbelow.

Now turning to <FIG>, portions of the removal device <NUM> may optionally be positioned in the passageway with the assistance of a positioning device, for example, such as an introducer core <NUM>. The introducer core <NUM> includes a rigid, elongate body <NUM> with a rounded groove <NUM> extending longitudinally therethrough. The groove <NUM> preferably has a contour that accommodates the navigation mechanism <NUM> (e.g., guidewire). For example, in one configuration, the groove <NUM> is preferably rounded to accommodate a substantially cylindrical guidewire.

The body <NUM> of the introducer core <NUM> terminates at a tapered tip <NUM> at an end <NUM> thereof. The tip <NUM> includes a taper that allows the introducer core <NUM> to be more easily inserted into the patient (i.e., through the patient's urethra). The introducer core <NUM> is adapted to be disposed in at least one of the passageways of the removal device <NUM> to provide support thereto. In one configuration, the introducer core <NUM> is inserted into the sheath <NUM>. In a different configuration, the introducer core <NUM> is inserted into a portion of the vacuum tube <NUM> (e.g., through the first or second passageway <NUM>, <NUM>, respectively).

The introducer core <NUM> may be utilized in one or more of the passageways in the removal device <NUM> to assist with positioning thereof. In a preferred configuration, the introducer core <NUM> is inserted into the first passageway <NUM> of the vacuum tube <NUM> to assist in placement thereof. The introducer core <NUM> preferably extends substantially the entire length of the first passageway to provide a rigid support for the vacuum tube <NUM> as the vacuum tube <NUM> is being positioned in the passageway (e.g., urinary tract). The introducer core <NUM> is preferably detachable such that it may be removed from the second passageway <NUM> (or other portion of the removal device <NUM>) after placement of the vacuum tube <NUM> is complete.

The removal device <NUM> is designed to be optionally utilized with the valve <NUM> (See <FIG>) that is in fluid communication with the suction source <NUM> and is capable of controlling the suction associated with the vacuum tube <NUM>. In one configuration, the valve <NUM> is a gate valve and may be designed to accommodate tubes and/or portions of the removal device <NUM> having varying diameters. The valve <NUM> preferably includes at least two different states, whereby the suction is supplied to the removal device <NUM> in a first state (i.e., via the vacuum tube <NUM>), and whereby the suction is not supplied to the removal device <NUM> in a second state. The valve <NUM> may also include intermediate states that allow the suction to be supplied at a specified level. The valve <NUM> may further include a safety feature such as an auto-shut down mechanism that terminates the suction once a threshold pressure is breached. Other types of valves may be utilized in conjunction with the removal device as known in the art.

The valve <NUM> is adapted to be in communication with the suction source <NUM> via a tube or other mechanism. In one configuration, the suction source <NUM> is a wall suction as known in the art. In a different configuration, the suction source <NUM> may be a standard suction unit that is stationary or otherwise portable. In a further configuration, the suction source <NUM> may be supplied in some other way. In one configuration, a suction source <NUM> capable of supplying a pressure of about -<NUM> mmHg is utilized, although it should be appreciated that the suction source <NUM> may supply other pressures as desired.

The removal device <NUM> may optionally include a sealable port (not shown), for example, such as one that uses a stopcock valve, for infusing or otherwise providing a liquid or other substance into the device <NUM>. In one configuration, saline is infused through one or more of the passageways of the removal device <NUM> described herein. In this configuration, the suction may be off or paused. In a different configuration, the suction may be used to assist in transporting or otherwise moving the substance through the removal device <NUM>.

Now turning to the use of the removal device <NUM>. In one configuration, the removal device <NUM> is adapted to be used in a medical setting. In particular, the removal device <NUM> may be used to remove debris or another foreign object (e.g., kidney stone, diseased tissue, and the like) from a patient (not shown). The debris may reside in one or more organs, orifices, or passageways. Accordingly, the removal device <NUM> may be utilized in any passageway to assist in removing debris therefrom or adjacent thereto.

In one configuration best seen in <FIG> and <FIG>, the removal device <NUM> is designed to be positioned in a patient's urinary tract. As depicted in <FIG>, the sheath <NUM> is inserted into the patient's urethra (not shown) and extends through the bladder <NUM> and ureter <NUM> until being positioned proximate a kidney stone(s) <NUM>, which is most likely disposed in a portion of the urinary tract (e.g., adjacent the kidney <NUM>). The ureterscope <NUM> (or other viewing instrument) is inserted into the sheath <NUM> along with the navigation mechanism <NUM>. The ureterscope <NUM> and navigation mechanism <NUM> are pushed through the sheath <NUM> until extending through substantially the entirety thereof. The ureterscope <NUM> is used to fracture the kidney stone(s) <NUM> into fragments <NUM> (see <FIG>) via a laser or other similar device. After the kidney stone(s) <NUM> are fractured, the ureterscope <NUM> is removed from the sheath <NUM>, and preferably, the navigation mechanism <NUM> is retained within the sheath <NUM>. Alternatively, in a different configuration, the navigation mechanism <NUM> may be removed.

As shown in <FIG>, the vacuum tube <NUM> is thereafter inserted into the sheath <NUM> and utilizes the navigation mechanism <NUM> for guidance thereof. The introducer <NUM> is disposed within the vacuum tube <NUM> (e.g., in the first passageway <NUM>) to maintain open communication through the passageways in the vacuum tube <NUM> during insertion into the patient. Additionally, the second passageway <NUM> of the vacuum tube <NUM> is aligned with the navigation mechanism <NUM>. As the vacuum tube <NUM> is pushed through the sheath <NUM> (via the introducer <NUM>), the navigation mechanism <NUM> aligns the second passageway <NUM> and guides the vacuum tube <NUM> to the fragments <NUM>. Once the vacuum tube <NUM> is positioned adjacent the fragments <NUM>, the introducer <NUM> is detached and removed therefrom. Once the introducer <NUM> has been removed, the valve <NUM> is opened to allow access to the suction source <NUM> and the fragments <NUM> are pulled from the patient through the removal device <NUM>. A catch or basket (not shown) may be utilized outside of the patient (or in a portion of the removal device <NUM>) to collect the fragments <NUM>, biopsied tissue, and/or other debris.

It should be noted that the removal device <NUM> may be utilized in the manner described herein without fracturing the kidney stone(s) <NUM>. In particular, the kidney stone(s) may be removed directly so long as they are sized to pass through the removal device <NUM>. The removal device <NUM> described herein is capable of removing debris having varying sizes. For example, the removal device <NUM> is designed to remove debris that are characterized as particles of dust (e.g., about <NUM> to about <NUM>,<NUM>).

The removal device <NUM> is also designed to remove small, medium, and large kidney stones or other debris. For example, in one configuration, the removal device <NUM> is designed to remove kidney stones having an approximate diameter of between about <NUM> to about <NUM>. In a different configuration, the removal device <NUM> is designed to remove kidney stones having an approximate diameter of between about <NUM> to about <NUM>. In a different configuration, the removal device <NUM> is designed to remove kidney stones having an approximate diameter of between about <NUM> to about <NUM>. In still a different configuration, the removal device <NUM> is designed to remove kidney stones having an approximate diameter of between about <NUM> to about <NUM>. It should be noted that, in one configuration, the removal device <NUM> described herein is designed to be utilized as described and does not utilize the working channel of a device (i.e., a ureterscope).

In a further configuration, the removal device <NUM> is designed for other medical uses, such as, to treat bladder stones and for use with other less invasive procedures, such as percutaneous stone removal, laparoscopic procedures, spine procedures, arthroscopic surgery, and microsurgery (e.g., to treat knee, ankle, foot, and hand issues). The removal device <NUM> may also be used to remove dead tissue, masses, and other debris. In a further configuration, the removal device <NUM> is used in a biopsy procedure.

The removal device <NUM> may be utilized in conjunction with visualization mechanisms including with, for example, fluoroscopy, ultrasound, computerized tomography (CT) scans, and magnetic resonance imaging. One or more portions of the removal device <NUM> may further comprise one or more radio opaque markers (not shown) and/or radio opaque materials to assist in inserting, positioning, and/or removing the removal device <NUM>. For example, a radio opaque marker may be disposed adjacent an end of the vacuum tube <NUM> and/or navigation mechanism <NUM> to assist in the positioning thereof. The marker may be visible to a physician under X-ray, fluoroscopy, or other visual aids. The removal device <NUM> may include one or more radio opaque markers on other portions thereof, including on the sheath <NUM>, the introducer core <NUM>, or other portions thereof. In use, the physician may use the mark(s), for example, to facilitate placement of the removal device <NUM> in the patient.

In one particular configuration, the removal device <NUM> is used in conjunction with fluoroscopy. In another configuration, the removal device <NUM> is used in conjunction with a cystoscope, miniature camera, or other visualization device. In this configuration, the removal device <NUM> is not inserted into or utilized by the working channel of the cystoscope. Rather, the cystoscope should have a relatively small diameter (e.g., less than about <NUM>) and the removal device <NUM> is used in conjunction (separately) therewith or designed as a system with direct visualization and the removal device. A navigation mechanism <NUM> may optionally be used in this configuration to guide the cystoscope and/or the removal device <NUM> to the desired location.

One or more portions of the removal device <NUM> including the sheath <NUM>, the vacuum tube <NUM>, the introducer core <NUM>, and/or the navigation mechanism <NUM> may include a hydrophilic or hydrophobic coating and/or may comprise a hydrophilic or hydrophobic material. In some configurations, the vacuum tube <NUM> is coated with a lubricious hydrophilic coating. In one configuration, the coating may be applied to any portion of the sheath <NUM> to reduce irritation caused by contact with the surrounding tissue in the urinary tract and/or bladder. In another configuration, the coating is applied to portions of the first passageway <NUM> of the vacuum tube <NUM> to facilitate debris removal therethrough. In another configuration, the coating is applied to portions of the second passageway <NUM> of the vacuum tube <NUM> to facilitate the guidance of the navigation mechanism <NUM> therethrough. The coating is preferably compatible with the materials used. In one particular configuration, the preferred coating is heparin, although it should be appreciated that other coatings may be utilized. Additionally, one or more portions of the removal device <NUM> may incorporate a material having the properties as described herein.

In a different configuration, the removal device <NUM> is used in non-medical applications. In particular, in one configuration, the removal device <NUM> is used to remove debris from a confined space, such as a hydraulic line, a plumbing line, and/or a petrochemical line, before, during, and/or after repairs to the line(s). The removal device <NUM> itself may be used to assist in repairing the line(s). Other non-medical uses include the use of the removal device <NUM> in ventilation systems such as heating and cooling systems and within mechanical or industrial pipes.

Thus, systems and methods are disclosed that are particularly advantageous for addressing the ureter and kidney using an aspirator. For example, some traditional devices treat attempt to meet clinical needs with a separate or dedicated aspirator. However, in the present disclosure, the aspirator may be inserted over a guidewire after a treatment, such as a ureteroscopy with laser, has been performed.

Claim 1:
A removal device (<NUM>) for use in a passageway of a urinary tract of an in vivo patient, comprising:
a vacuum tube (<NUM>) comprising a first passageway (<NUM>) and a second passageway (<NUM>) extending longitudinally through the first passageway, wherein the vacuum tube (<NUM>) is configured to be disposed at least partially within the passageway of the urinary tract, and is designed to accommodate suction provided from a suction source (<NUM>), wherein the second passageway is characterized by a diameter of between about <NUM> (<NUM> Fr.) and about <NUM> (<NUM> Fr.);
an introducer (<NUM>) configured to be disposed in one of the passageways to assist with positioning of the vacuum tube;
a guidewire (<NUM>) accommodated within the introducer; and
a port coupled to the removal device adapted to receive saline for infusion through one of the passageways.