Abstract:
In accordance with some configurations, systems and methods for guided removal from an in vivo subject are provided. In some configurations, a method for removing an object is provided. The method comprising, guiding a flexible tube through an in vivo subject&#39;s ureter, wherein the flexible tube comprises at least a first passageway and a second passageway. Positioning a distal end of the first passageway adjacent to the object. Infusing saline solution through the second passageway while suction is off. Removing the object through the first passageway with at least a portion of the saline solution.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation-in-part, under 35 U.S.C. §120, of U.S. application Ser. No. 14/774,418, filed Sep. 10, 2015, which is a National Stage, under 35 U.S.C. §371, of International Application No. PCT/US2014/026037, filed Mar. 13, 2014, which claims the benefit, under 35 U.S.C. §119(e), of U.S. Provisional Application No. 61/783,239, filed Mar. 14, 2013. Each of the foregoing applications is hereby incorporated herein by reference in its entirety for all purposes. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    The present invention relates to systems and 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. 
         [0003]    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 1 cm) to very large (more than 4 cm) 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 1 cm. 
         [0004]    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&#39;s back into the kidney). 
         [0005]    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&#39;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&#39;s body and then removed via a vacuum or other known methods (nephrolithotripsy). 
         [0006]    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 1 cm) depending on the size and location of the stones. 
         [0007]    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 clinically significant kidney stones and kidney stone fragments are broken up and removed from the body. 
         [0008]    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. 
         [0009]    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 2 French and 3 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 3 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 3 French). Accordingly, the prior art devices of this type are unable to remove debris greater than about 2 mm 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 1 mm or less. 
         [0010]    Kidney stone removal techniques may also make use of irrigation systems, devices, and methods to remove stone fragments from the patient. Irrigation is often used during a ureteroscope procedure. 
         [0011]    For example, some prior-art devices use irrigation to introduce a liquid, such as water or saline solution, into the kidney. Such irrigation can be used to perform a cleansing that washes very small particles out of the remote interior regions of the kidney. However, any liquid that is introduced must drain from the kidney both during and after the procedure. Therefore, the volume of liquid that can be introduced is necessarily limited, and there is no strong liquid flow to remove fragments that are wetted by the liquid from the kidney. A more effective irrigation procedure is needed to rapidly and reliably remove particles, fragments and debris from the kidney. 
         [0012]    A stent may be introduced following removal of stones from a kidney. A retrograde Pyelogram contrast study can be used to both verify that all clinically-relevant fragments have been removed, and to evaluate the extent of injury to the urinary collecting system. In particular, a contrast study provides information on the extent of extravasation of blood and other bodily fluids, which is indicative of the extent of injury. Information gained from a contrast study is useful in making decisions on where to place a stent and how long to leave it in place. 
         [0013]    Thus, to further facilitate adoption of new systems, methods, and devices for kidney stone removal, it is desirable to ensure compatibility with stent placement. Placement of a stent after the removal procedure results in improved drainage and accelerated healing. It is not uncommon for edema of the ureter to occur post-procedure, resulting in significant pain. Improving drainage through placement of a stent can reduce the extent of such edema and associated pain. Furthermore, studies show that dilation of the ureter by a stent contributes to more rapid healing. For these reasons, a stent is used in the majority of such procedures worldwide, and in the overwhelming majority of stone removal procedures in the United States. Accordingly, new methods and devices that address the removal of debris greater than about 3 mm and are compatible with stent placement are desirable. 
       SUMMARY 
       [0014]    In accordance with some configurations of the disclosed subject matter, methods for removing an object through a passageway of an in vivo subject are provided. 
         [0015]    In accordance with some configurations, a method for removing an object through a passageway of an in vivo subject is provided, the method comprising: inserting a ureteroscope into the passageway; positioning the ureteroscope adjacent to an object to break the object into fragments; removing the ureteroscope from the passageway; guiding a multi-lumen catheter into the passageway adjacent to the fragments of the object using a fluoroscopic imaging device and a guide wire; opening a valve to apply suction to remove at least a portion of the fragments; removing the multi-lumen catheter from the passageway; placing a stent in the passageway; and removing the guide wire from the passageway. 
         [0016]    In some configurations, the method further comprises re-inserting the ureteroscope following removal of multi-lumen catheter to confirm removal of the fragments. 
         [0017]    In some configurations, re-inserting the ureteroscope following removal of multi-lumen catheter is performed prior to placing the stent. 
         [0018]    In some configurations, the method further comprises injecting an irrigation fluid along a first lumen in the multi-lumen catheter and simultaneously or intermittently providing suction through a second lumen in the multi-lumen catheter to remove the fluid and debris along the second lumen. 
         [0019]    In some configurations, the method further comprises injecting an irrigation fluid along a first lumen in the multi-lumen catheter by first closing the suction valve and introducing a controlled amount of fluid, then opening the valve to provide suction through the first lumen to remove the fluid and debris. 
         [0020]    In some configurations, a first lumen of the multi-lumen catheter has a diameter between 0.5 Fr to 8 Fr. 
         [0021]    In some configurations, a second lumen of the multi-lumen catheter has a diameter between 3 Fr to 30 Fr. 
         [0022]    In some configurations, the object is a kidney stone. 
         [0023]    In some configurations, the passageway is accessed laparoscopically or arthroscopically. 
         [0024]    In some configurations, the object is diseased tissue and the passageway is located in an organ or an orifice of an in vivo subject. 
         [0025]    In some configurations, the object includes a bladder stone or percutaneous stone. 
         [0026]    In accordance with some configurations of the disclosed subject matter, a method for removing an object from a passageway within an in vivo subject is provided, the method comprising: inserting a guide wire along the passageway; positioning a sheath over the guide wire; inserting a ureteroscope into the passageway; positioning the ureteroscope adjacent to an object to break the object into fragments; removing the ureteroscope from the sheath; guiding a multi-lumen catheter into the passageway adjacent to the fragments of the object using fluoroscopic imaging and a guide wire; opening a valve to apply suction to remove fragments; removing the multi-lumen catheter from the passageway; placing a stent in the passageway; and removing the guide wire from the passageway. 
         [0027]    In some configurations, the method further comprises re-inserting the ureteroscope following removal of multi-lumen catheter to inspect fragment removal. 
         [0028]    In some configurations, the method further comprises re-inserting the ureteroscope following removal of multi-lumen catheter and prior to placing the stent to inspect fragment removal. 
         [0029]    In some configurations, the method further comprises injecting an irrigation fluid along a first lumen in the multi-lumen catheter, while simultaneously or intermittently providing suction to remove the fluid and fragments along a second lumen. 
         [0030]    In some configurations, the method further comprises injecting an irrigation fluid along a first lumen in the multi-lumen catheter by closing the suction valve, then opening the valve to provide suction to remove the fluid and fragments along a second lumen in the multi-lumen catheter. 
         [0031]    In some configurations, the object is a kidney stone. 
         [0032]    In some configurations, the passageway is a urinary tract of a human. 
         [0033]    In some configurations, at least one of the fragments of the object is at least a portion of a kidney stone having a diameter less than 3.3 mm. 
         [0034]    In some configurations, the object is bladder stone or percutaneous stone. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0035]      FIG. 1  is an isometric view of a removal device including a sheath, a vacuum tube, an introducer, and a navigation mechanism; 
           [0036]      FIG. 2  is an isometric view of a sheath of the removal device of  FIG. 1 ; 
           [0037]      FIG. 3  is an isometric view of the vacuum tube and navigation mechanism of  FIG. 1 ; 
           [0038]      FIG. 4  is a front elevational view of the vacuum tube of  FIG. 3 , with the navigation mechanism removed therefrom for clarity; 
           [0039]      FIG. 5  is a partial isometric view of the introducer of the removal device of  FIG. 1  enlarged for magnification purposes; 
           [0040]      FIG. 6  is a partial schematic view of the removal device of  FIG. 1  further including a valve that is in communication with a suction source; 
           [0041]      FIG. 7  is a partial schematic view depicting a possible installation of a removal device in a urinary tract of a patient in a first state, wherein a ureteroscope is disposed in the sheath of  FIG. 1  adjacent a kidney stone; and 
           [0042]      FIG. 8  is a partial schematic view of the removal device of  FIG. 7  in a second state, wherein the vacuum tube and navigation mechanism of  FIG. 1  is disposed adjacent kidney stone fragments. 
           [0043]      FIG. 9A  is a perspective view of a dual lumen vacuum tube that can be used with the removal device of  FIG. 1 . 
           [0044]      FIG. 9B  is a front elevational view of the vacuum tube of  FIG. 9A . 
           [0045]      FIGS. 10A and 10B  show an example of a flow chart setting forth some examples of steps in a process for removing an object from a passageway using the removal device described herein. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0046]    Referring generally to  FIGS. 1-8 , a removal device  100  includes a sheath  102 , a vacuum tube  104 , and a navigation mechanism  106 . The removal device  100  optionally includes an introducer core  108  adapted to assist in positioning one or more portions of the removal device  100  in a passageway. The removal device  100  further optionally includes a valve  110  that is in communication with, and assists in controlling suction that is supplied to the vacuum tube  104 . One or more of the sheath  102 , navigation mechanism  106 , and/or introducer core  108  may be optional for use with the removal device  100 . For example, in one configuration, the sheath  102  is omitted from the removal device  100 . 
         [0047]    As best seen in  FIGS. 7 and 8 , the removal device  100  is designed to be positioned in a passageway of a patient (e.g., urinary tract), and in particular, into a patient&#39;s ureter  112 . The removal device  100  includes a renal end  114  designed to be positioned proximate the patient&#39;s kidney  116 , and more particularly, adjacent to one or more kidney stones  118 . The removal device  100  includes a bladder end  120  that is designed to extend through the bladder  122  and out of the patient through the urethra (not shown). The removal device  100  provides an uninterrupted passageway from the kidney stones  118  or kidney stone fragments in the kidney  116 , through the ureter  112  and bladder  122 , and out of the patient. 
         [0048]    Now turning to  FIGS. 1 and 2 , the sheath  102  is provided as at least one substantially cylindrical tube  130  defining a lumen. The tube  130  includes at least one passageway  132  extending substantially longitudinally therethrough, although additional passageways may be included in the sheath  102  as desired. The passageway  132  extends through the entirety of the sheath  102  and is adapted to receive a ureteroscope  134  (see  FIG. 7 ) and/or other viewing instrument. The ureteroscope  134  preferably includes a laser (not shown) or other mechanism that fractures the kidney stone  118  into smaller fragments (or dust). The passageway  132  is also designed to accommodate the vacuum tube  104  and/or navigation mechanism  106  therein, as described in more detail hereinbelow. The tube  130  is preferably substantially cylindrical to conform to the orifice and/or passageway of the patient in which the removal device  100  is designed to be utilized. In other configurations, the tube  130  includes other shapes as desired. It should also be noted that the sheath  102  may be omitted from the removal device  100  altogether such that the vacuum tube  104  is utilized and serves the function of the sheath  102 , which is discussed hereinbelow. 
         [0049]    The sheath  102  is preferably made of a biocompatible material that is rigid enough to support the other components of the removal device  100  (e.g., the vacuum tube  104  and navigation mechanism  106 ), but elastic enough to conform to the contours of the passageway of the patient. For example, suitable materials for use as the sheath  102  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. 
         [0050]    The sheath  102  is preferably defined by a length dimension of about 15 cm to about 45 cm. In a different configuration, the sheath  102  includes a length dimension of about 20 cm to about 35 cm. In a further configuration, the sheath  102  has a length dimension of about 25 cm to about 30 cm. It should be apparent that the length of the sheath  102  may be adjusted in view of numerous factors including, for example, patient size. 
         [0051]    The sheath  102  is further defined by an interior diameter dimension of the tube  130 . In one configuration, the interior diameter of the tube  130  is between about 2 Fr. to about 30 Fr. In a different configuration, the interior diameter of the tube  130  is between about 10 Fr. to about 16 Fr. In another configuration, the interior diameter is between about 12 Fr. to about 14 Fr. 
         [0052]    Now turning to  FIGS. 3 and 4 , the vacuum tube  104  is characterized by an elongate dual lumen  140  defined by a first (larger) passageway  142  and a second (smaller) passageway  144  extending longitudinally therethrough. The vacuum tube  104  may optionally include a specialized tip (not shown) at an end thereof that assists in maintaining the patency of the vacuum tube  104 . The tip may also allow the vacuum tube  104  to be positioned in areas that are difficult to access (e.g., the lowest part of the kidney). 
         [0053]    The first passageway  142  is designed to accommodate the introducer  108 , which is used to assist in positioning one or more portions of the removal device  100  in the patient, as explained in more detail hereinbelow. The first passageway  142  is also designed to accommodate the suction provided from a suction source  148  (see  FIG. 6 ) that is utilized with the removal device  100 . The first passageway  142  of the vacuum tube  104  guides the suction to an area adjacent the kidney stones  118  (and/or kidney stone fragments) and facilitates the kidney stones  118  being removed therethrough. The first passageway  142  acts as a primary passageway for removal of the kidney stones  118  (and/or kidney stone fragments). 
         [0054]    Still referring to  FIGS. 3 and 4 , the second passageway  144  of the vacuum tube  104  is disposed adjacent an internal surface  160  of the lumen  140  and is designed to accommodate the navigation mechanism  106  as shown in  FIG. 3 . In a different configuration, the second passageway  144  may also accommodate a ureteroscope or other viewing instrument. In still a further configuration, the second passageway  144  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  142 ,  144 . Although depicted adjacent the internal surface  160 , the second passageway  144  may be disposed in any other location within the vacuum tube  104 , or may be omitted all together. Further, the size of the first and second passageways  142 ,  144  may be adjusted as desired. 
         [0055]    In a different configuration, the removal device  100  and/or vacuum tube  104  includes additional lumens extending therethrough. For example, in one configuration, the removal device  100  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. 
         [0056]    The vacuum tube  104  is preferably made of a flexible biocompatible material such that the vacuum tube  104  is able to move through the contours of the passageway of the patient. The vacuum tube  104  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  104  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. 
         [0057]    One or more portions of the vacuum tube  104  may include a coating and/or may comprise a hydrophilic or hydrophobic material. The coating may assist in positioning the vacuum tube  104  within the sheath  102 , positioning the navigation mechanism  106  within the vacuum tube  104 , and/or assisting in debris removal through the first passageway  142 . 
         [0058]    The vacuum tube  104  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. 
         [0059]    In one configuration, the vacuum tube  104  includes a hydrophilic or hydrophobic coating and the vacuum tube  104  is used without the sheath  102 . In a different configuration, the vacuum tube  104  is designed to be disposed at least partially within the sheath  102  during use. Therefore, the circumference of the vacuum tube  104  is smaller than that of the sheath  102 . The lumen  140  of the vacuum tube  104  is defined by a diameter of between about 3 Fr. to about 30 Fr., more preferably between about 10 Fr. to about 18 Fr., and most preferably between about 11 Fr. to about 13 Fr. In one configuration, the lumen  140  of the vacuum tube  104  is about 10 Fr. In a different configuration, the lumen  140  of the vacuum tube  104  is about 11 Fr. In still a different configuration, the lumen  140  of the vacuum tube  104  is about 12 Fr. 
         [0060]    The diameter of the second passageway  144  of the vacuum tube  104  is smaller than the diameter of the lumen  140  and is characterized by a diameter of between about 0.5 Fr. to about 8 Fr., and more preferably between about 3 Fr. to about 6 Fr. In one configuration, the second passageway  144  of the vacuum tube  104  is about 3 Fr. In a different configuration, the second passageway  144  of the vacuum tube  104  is about 4 Fr. In still a different configuration, the first passageway  144  of the vacuum tube  104  is about 7 Fr. 
         [0061]    Still referring to  FIG. 3 , as discussed previously, the second passageway  144  of the vacuum tube  104  is designed to accommodate the navigation mechanism  106  as shown in  FIG. 3 . The navigation mechanism  106  is preferably provided in the form of a guidewire. Guidewires suitable for use in the removal device  100  are characterized by a diameter of between about 0.014 in. to about 1 in. In one configuration, the guidewire is characterized by an elongate flexible material having a diameter of about 0.035 in. or about 0.038 in. Guidewires suitable for use with the removal device  100  include, for example, the Sensor™ guidewire provided by Boston Scientific (Natick, Mass.), or the Glidewire™ provided by Terumo International Systems (Tokyo, Japan). Additionally, the removal device  100  may be utilized in conjunction with the guidewire described in U.S. patent application Ser. No. 12/660,891, filed on Mar. 5, 2010, and incorporated by reference in its entirety. In other configurations, the navigation mechanism  106  may comprise other devices or mechanisms that assist in positioning portions of the removal device  100 . 
         [0062]    The vacuum tube  104  and/or other portions of the removal device  100  may be controlled using various control mechanisms. For example, in one configuration, the vacuum tube  104  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  104 , and/or controlling (e.g., increasing or decreasing) the level of suction. 
         [0063]    In one configuration, the guidewire is designed to be inserted into the patient and navigated to the kidney  116 . The removal device  100  is passed over the guidewire through one of the passageways described herein (e.g., the second passageway  144 ). In some instances, the sheath  102  is optionally inserted into the patient first, followed by one or more of the guidewire and/or removal device  100 . 
         [0064]    In a different configuration, the removal device  100  is designed to interact with and pass over the guidewire. In one configuration, the guidewire is inserted into the sheath  102 . In a different configuration, the guidewire is inserted into a portion of the vacuum tube  104  (e.g., through the first or second passageway  142 ,  144 , respectively). The guidewire may be utilized in one or more of the passageways in the removal device  100 . In a preferred configuration, the guidewire is initially inserted into the flexible tube  130  of the sheath  102  in conjunction with the ureteroscope  134 . The guidewire is also preferably utilized in conjunction with the second passageway  144  as a guidance mechanism for the vacuum tube  104  as described in more detail hereinbelow. 
         [0065]    Now turning to  FIG. 5 , portions of the removal device  100  may optionally be positioned in the passageway with the assistance of a positioning device, for example, such as an introducer core  108 . The introducer core  108  includes a rigid, elongate body  170  with a rounded groove  172  extending longitudinally therethrough. The groove  172  preferably has a contour that accommodates the navigation mechanism  106  (e.g., guidewire). For example, in one configuration, the groove  172  is preferably rounded to accommodate a substantially cylindrical guidewire. 
         [0066]    The body  170  of the introducer core  108  terminates at a tapered tip  174  at an end  176  thereof. The tip  174  includes a taper that allows the introducer core  108  to be more easily inserted into the patient (i.e., through the patient&#39;s urethra). The introducer core  108  is adapted to be disposed in at least one of the passageways of the removal device  100  to provide support thereto. In one configuration, the introducer core  108  is inserted into the sheath  102 . In a different configuration, the introducer core  108  is inserted into a portion of the vacuum tube  104  (e.g., through the first or second passageway  142 ,  144 , respectively). 
         [0067]    The introducer core  108  may be utilized in one or more of the passageways in the removal device  100  to assist with positioning thereof. In a preferred configuration, the introducer core  108  is inserted into the first passageway  142  of the vacuum tube  104  to assist in placement thereof. The introducer core  108  preferably extends substantially the entire length of the first passageway to provide a rigid support for the vacuum tube  104  as the vacuum tube  104  is being positioned in the passageway (e.g., urinary tract). The introducer core  108  is preferably detachable such that it may be removed from the second passageway  142  (or other portion of the removal device  100 ) after placement of the vacuum tube  104  is complete. 
         [0068]    The removal device  100  is designed to be optionally utilized with the valve  110  (See  FIG. 6 ) that is in fluid communication with the suction source  148  and is capable of controlling the suction associated with the vacuum tube  104 . In one configuration, the valve  110  is a gate valve and may be designed to accommodate tubes and/or portions of the removal device  100  having varying diameters. The valve  110  preferably includes at least two different states, whereby the suction is supplied to the removal device  100  in a first state (i.e., via the vacuum tube  104 ), and whereby the suction is not supplied to the removal device  100  in a second state. The valve  110  may also include intermediate states that allow the suction to be supplied at a specified level. The valve  110  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. 
         [0069]    The valve  110  is adapted to be in communication with the suction source  148  via a tube or other mechanism. In one configuration, the suction source  148  is a wall suction as known in the art. In a different configuration, the suction source  148  may be a standard suction unit that is stationary or otherwise portable. In a further configuration, the suction source  148  may be supplied in some other way. In one configuration, a suction source  148  capable of supplying a pressure of about −22 mmHg is utilized, although it should be appreciated that the suction source  148  may supply other pressures as desired. 
         [0070]    The removal device  100  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  100 . In one configuration, saline is infused through one or more of the passageways of the removal device  100  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  100 . 
         [0071]    Now turning to the use of the removal device  100 . In one configuration, the removal device  100  is adapted to be used in a medical setting. In particular, the removal device  100  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  100  may be utilized in any passageway to assist in removing debris therefrom or adjacent thereto. 
         [0072]    In one configuration best seen in  FIGS. 7 and 8 , the removal device  100  is designed to be positioned in a patient&#39;s urinary tract. As depicted in  FIG. 7 , the sheath  102  is inserted into the patient&#39;s urethra (not shown) and extends through the bladder  122  and ureter  112  until being positioned proximate a kidney stone(s)  118 , which is most likely disposed in a portion of the urinary tract (e.g., adjacent the kidney  116 ). The ureteroscope  134  (or other viewing instrument) is inserted into the sheath  102  along with the navigation mechanism  106 . The ureteroscope  134  and navigation mechanism  106  are pushed through the sheath  102  until extending through substantially the entirety thereof. The ureteroscope  134  is used to fracture the kidney stone(s)  118  into fragments  180  (see  FIG. 8 ) via a laser or other similar device. After the kidney stone(s)  118  are fractured, the ureteroscope  134  is removed from the sheath  102 , and preferably, the navigation mechanism  106  is retained within the sheath  102 . Alternatively, in a different configuration, the navigation mechanism  106  may be removed. 
         [0073]    As shown in  FIG. 8 , the vacuum tube  104  is thereafter inserted into the sheath  102  and utilizes the navigation mechanism  106  for guidance thereof. The introducer  108  is disposed within the vacuum tube  104  (e.g., in the first passageway  142 ) to maintain open communication through the passageways in the vacuum tube  104  during insertion into the patient. Additionally, the second passageway  144  of the vacuum tube  104  is aligned with the navigation mechanism  106 . As the vacuum tube  104  is pushed through the sheath  102  (via the introducer  108 ), the navigation mechanism  106  aligns the second passageway  144  and guides the vacuum tube  104  to the fragments  180 . Once the vacuum tube  104  is positioned adjacent the fragments  180 , the introducer  108  is detached and removed therefrom. Once the introducer  108  has been removed, the valve  110  is opened to allow access to the suction source  148  and the fragments  180  are pulled from the patient through the removal device  100 . A catch or basket (not shown) may be utilized outside of the patient (or in a portion of the removal device  100 ) to collect the fragments  180 , biopsied tissue, and/or other debris. 
         [0074]    Another configuration for a vacuum tube  204  that can be used in connection with removal device  100  is shown in  FIGS. 9A and 9B . As shown in  FIGS. 9A and 9B , the vacuum tube  204  can be characterized by an elongate dual lumen  240  defined by a first (larger) passageway  242  and a second (smaller) passageway  244  extending longitudinally therethrough. The second passageway  244  can be disposed adjacent an internal surface  260  of the dual lumen  240 . For example, as illustrated, the second passageway  244  can share a portion of a wall with the internal surface  260  and/or be fused to the internal surface  260 . In one configuration, the first passageway  242  can be used to accommodate suction from the suction source  148  (e.g., as described above in connection with  FIG. 6 ). 
         [0075]    Still referencing  FIGS. 9A and 9B , the second passageway  244  of the vacuum tube  204  can be configured to accommodate the navigation mechanism  106  (e.g., a guidewire) and/or another device (e.g., ureteroscope  134 , another viewing instrument, etc.). Additionally, in some configurations, the first passageway  242  of the vacuum tube  204  can be configured to accommodate the navigation mechanism  106  (e.g., a guidewire) and/or another device (e.g., ureteroscope  134 , another viewing instrument, etc.). In some configurations, the second passageway  244  can accommodate the flow of an irrigation fluid from a fluid irrigation source to a distal end of the vacuum tube  204  to facilitate the removal of debris through an in vivo passageway of a patient (e.g., after removal of the navigation mechanism  106  and/or any other device). For example, in one particular non-limiting configuration, the fluid irrigation source can be a syringe connected through any suitable connection, such as a needle that is in fluid communication with the second passageway  244  of the vacuum tube  204 , a luer-type connector that is in fluid communication with the second passageway  244  of the vacuum tube  204 , and/or any other suitable connector. Pressure can be applied to the syringe to dispense the irrigation fluid through the second passageway  244  in the direction of the object to be removed. In other non-limiting examples, in addition to, and/or in lieu of, the syringe described above, the fluid irrigation source can include a wash bottle, a positive displacement pump, or any other suitable fluid irrigation sources known to those skilled in the art. 
         [0076]    The vacuum tube  204  can be configured to selectively provide suction (e.g., through the first passageway  242 ) from the suction source (e.g., suction source  148  described above in connection with  FIGS. 1-8 ) before, during and/or after flushing a target region of the in vivo passageway with the irrigation fluid. For example, as described above, the valve  110  (as shown in  FIG. 6 ) can be used to control suction that is supplied to the vacuum tube  204 . The first passageway  242  and the second passageway  244  can be configured to be any suitable sizes. 
         [0077]    Operation of the removal device  100  when removing a kidney stone  118  from a patient&#39;s kidney  116  through the patient&#39;s ureter  112  is described below with reference to  FIGS. 10A and 10B . The removal device  100  can include any suitable configuration, such as configurations described above in connection with  FIGS. 1 to 9B . Additionally or alternatively, in some configurations, the removal device  100  can be configured for other medical uses such as treating bladder stones, and/or for use with other 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  100  can also be used to remove dead tissue, masses, and other debris. In a further configuration, the removal device  100  can be used in biopsy procedures. 
         [0078]    At  1000 , the removal device  100  can be configured to locate the passageway that contains the object for removal. In one non-limiting configuration, the passageway can be located using a cystoscope, which can be inserted into the bladder and used to find the opening to the patient&#39;s ureter  112 . 
         [0079]    At  1002 , the navigation mechanism  106  can be inserted into the passageway  132  of the patient. In some configurations, the navigation mechanism  106  includes a guide wire that is inserted into the patient&#39;s ureter  112 , and passed through to the patient&#39;s kidney  116 . A sheath  102  can then be optionally positioned over the navigation mechanism. If the sheath  102  is being used in the procedure (“YES” at  1004 ), the sheath can be positioned in the patient&#39;s ureter  112  at  1006 . 
         [0080]    At  1008 , an endoscope can be inserted into the passageway of the patient and positioned adjacent to the target object (e.g., a kidney stone). Note that the endoscope can be used regardless of whether the sheath is being used at  1004 . In a non-limiting example, the endoscope can be a ureteroscope (e.g., the ureteroscope  134 ) that can be positioned adjacent to a kidney stone  118  within a patient&#39;s kidney  116 . 
         [0081]    At  1010 , the endoscope can be used to fragment the object using any suitable technique or combination of techniques. For example, in some configurations, the ureteroscope includes a laser that can be used to break the kidney stone  118  into fragments until the fragments have reached a suitable sized, such as roughly 3 mm or smaller. It is to be appreciated that, in some configurations, the ureteroscope can be maneuvered without the assistance of the guide wire  106 . At  1012 , the endoscope can be removed from the patient&#39;s ureter  112  and/or from the sheath  102 . 
         [0082]    At  1014 , a catheter can be inserted into the passageway of the patient and/or the sheath  102  of the removal device  100 . In some configurations, the catheter can include multiple lumens. For example, as described above in connection with  FIG. 3 , the first lumen can be the first passageway  142  of vacuum tube  104 , and the second lumen can be the second passageway  144 , which can, among other things, accommodate the navigation mechanism  106 , and/or can be in fluid communication with the irrigation fluid source. Alternatively, a variety of catheters with various configurations can be used, such as the configuration described above in connection with  FIGS. 9A and 9B . Note that, in some configurations, the catheter can be inserted through sheath  102  and/or the in vivo passageway of the patient and the endoscope can be inserted through the catheter. For example, as described above in connection with  FIGS. 9A and 9B , the second passageway of the vacuum tube  204  can accommodate an appropriately sized endoscope (e.g., an endoscope having an external diameter less than or equal to about 1 millimeter). 
         [0083]    At  1016 , the fragments within the passageway of the patient can be removed using the vacuum tube. In one non-limiting configuration, a fluoroscope may be used as a visual guide to position the vacuum adjacent to the fragments to be removed. In some configurations, an irrigation fluid can be used to assist in the removal of the fragments from the passageway  134 . If irrigation is to be used (“YES” at  1018 ), in one non-limiting configuration, an irrigation fluid source (e.g., a syringe containing irrigation fluid, a pump, etc.) can be coupled to at least one lumen of the catheter to place the irrigation fluid source into fluid communication with the at least one lumen in the catheter. If irrigation fluid is to be used, the suction and irrigation provided through the removal device  100  can be configured to operate sequentially (“YES” at  1020 ) or simultaneously (“NO” at  1020 ). If suction and irrigation are to be provided simultaneously (“NO” at  1020 ), at  1022 , the valve  110  in fluid communication with the catheter can be opened to provide suction through a first lumen of the catheter (e.g., the first passageway  242  of the vacuum tube  204 ) during injection of the irrigation fluid through a second lumen of the catheter (e.g., the second passageway  244  of the vacuum tube  204 ). Alternatively, if suction and irrigation are to be provided sequentially (“YES” at  1020 ), at  1024 , the valve  110  in fluid communication with the catheter can be closed and/or can remain closed while irrigation fluid is injected through the catheter, at  1026 . 
         [0084]    At  1028 , the valve  110  can be opened to provide suction through a lumen of the catheter (which may be the same or different than the lumen through which irrigation fluid was provided). At  1030 , the valve  110  can be closed to stop suction through the lumen of the catheter through which suction was being provided. In some configurations, injecting irrigation fluid at  1026 , providing suction to remove irrigation fluid and/or fragments at  1028 , and stopping suction at  1030  can be repeated any suitable number of times. At  1032 , the catheter can be removed from the passageway of the patient. 
         [0085]    If a post-inspection of the passageway  132  is to be performed (“YES” at  1034 ), at  1036 , an endoscope can be inserted into the sheath  102  and/or the passageway  134  to inspect whether there are any remaining fragments to be removed. If there are remaining fragments to be removed (“NO” at  1038 ),  1010  through  1034  can be repeated as necessary until there are no longer fragments to be removed. Otherwise, if the results are acceptable (“YES” at  1038 ), at  1042  the endoscope (and if present, at  1044 , the sheath  102 ) can be removed from the passageway  134 . 
         [0086]    At  1046 , the passageway  134  can be imaged to inspect for any remaining fragments or other debris and any potential damage (e.g., caused by the procedure). In one non-limiting example, any suitable technique or combination of techniques can be used to image the passageway of the patient. For example, a retrograde pyelogram, an intravenous pyelogram (IVP), and/or any other suitable technique can be performed to provide images of the patient&#39;s kidneys  116 , the patient&#39;s ureter  112 , and/or the urinary tract in order to identify problems with the structure or the presence of kidney stones  118 , tumors, infection, etc. In some configurations, the retrograde pyelogram or IVP can be performed in association with another suitable imaging technique or combination of techniques, such as an ultrasound, a computed tomography (CT) scan, etc. 
         [0087]    At  1048 , in some embodiments, a stent can be placed in the passageway  132  of the patient, and the navigation mechanism  106  can be removed at  1050 . Note that, in some configurations, the navigation mechanism  106  can be removed at any suitable time, such as prior to providing irrigation fluid (e.g., in configurations where the same lumen is used for the navigation mechanism  106  and irrigation). 
         [0088]    It should be noted that the removal device  100  may be utilized in the manner described herein without fracturing the kidney stone(s)  118 . In particular, the kidney stone(s) may be removed directly so long as they are sized to pass through the removal device  100 . The removal device  100  described herein is capable of removing debris having varying sizes. For example, the removal device  100  is designed to remove debris that are characterized as particles of dust (e.g., about 0.001 μm to about 10,000 μm). 
         [0089]    The removal device  100  is also designed to remove small, medium, and large kidney stones or other debris. For example, in one configuration, the removal device  100  is designed to remove kidney stones having an approximate diameter of between about 0.0001 mm to about 8 mm. In a different configuration, the removal device  100  is designed to remove kidney stones having an approximate diameter of between about 0.1 mm to about 6 mm. In a different configuration, the removal device  100  is designed to remove kidney stones having an approximate diameter of between about 1 mm to about 5 mm. In still a different configuration, the removal device  100  is designed to remove kidney stones having an approximate diameter of between about 2 mm to about 4 mm. It should be noted that, in one configuration, the removal device  100  described herein is designed to be utilized as described and does not utilize the working channel of a device (i.e., a ureteroscope). 
         [0090]    In a further configuration, the removal device  100  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  100  may also be used to remove dead tissue, masses, and other debris. In a further configuration, the removal device  100  is used in a biopsy procedure. 
         [0091]    The removal device  100  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  100  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  100 . For example, a radio opaque marker may be disposed adjacent an end of the vacuum tube  104  and/or navigation mechanism  106  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  100  may include one or more radio opaque markers on other portions thereof, including on the sheath  102 , the introducer core  108 , or other portions thereof. In use, the physician may use the mark(s), for example, to facilitate placement of the removal device  100  in the patient. 
         [0092]    In one particular configuration, the removal device  100  is used in conjunction with fluoroscopy. In another configuration, the removal device  100  is used in conjunction with a cystoscope, miniature camera, or other visualization device. In this configuration, the removal device  100  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 3 mm) and the removal device  100  is used in conjunction (separately) therewith or designed as a system with direct visualization and the removal device. A navigation mechanism  106  may optionally be used in this configuration to guide the cystoscope and/or the removal device  100  to the desired location. 
         [0093]    Thus, systems and methods are disclosed that are particularly advantageous for addressing the ureter and kidney using an aspirator. For example, some traditional devices 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. 
         [0094]    The present invention has been described in terms of one or more preferred embodiments, and it should be appreciated that many equivalents, alternatives, variations, and modifications, aside from those expressly stated, are possible and within the scope of the invention.