Abstract:
Medical devices, methods and kits useful in the disruption and removal of unwanted materials, such as calculi and other formations, from within body lumens are described. The disclosure describes particular embodiments and methods useful in the lithotriptic removal of stones from the salivary glands.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation of U.S. patent application Ser. No. 13/606,323, filed on Sep. 7, 2012, and which claims the benefit of U.S. Provisional Application Ser. No. 61/533,191, filed on Sep. 10, 2011. The entire contents of each of these related applications is incorporated into this disclosure by reference. 
     
    
     FIELD 
       [0002]    The disclosure relates generally to the field of medical devices. More particularly, the disclosure relates to medical devices, methods and kits useful in the disruption and removal of unwanted materials, such as calculi and other formations, from within body lumens. The disclosure describes particular embodiments and methods useful in the lithotriptic removal of stones from the salivary glands. 
       BACKGROUND 
       [0003]    The treatment of various medical conditions related to the salivary ducts can involve several techniques, including wire insertion, dilation of the papilla and duct, sheath insertion, irrigation, visualization, balloon dilatation of strictures, lithotripsy, and stone removal. In the salivary duct, each of these procedures is complicated by the size of the duct itself, which is relatively small in comparison to other body vessels within which minimally invasive procedures have become common, such as the vessels of the vasculature system. Lithotripsy procedures can be particularly challenging in these relatively small ducts because of the need for removal of stone fragments from the duct following disruption of the stone. 
         [0004]    While the use of a suction force can aid in the removal of stone fragments during a lithotripsy procedure, its use in the salivary ducts risks collapse of the duct structure due to the relative small size. The art lacks an adequate device that allows for the use of suction during lithotripsy procedures while addressing this unique challenge presented by these ducts. 
         [0005]    Thus, a need exists for improved lithotripsy devices, methods and kits that are particularly well-suited for use in the salivary ducts and other small body vessels. 
       BRIEF SUMMARY 
       [0006]    Various exemplary methods are described and illustrated herein. 
         [0007]    An exemplary method of removing an impediment in a body vessel of a patient comprises introducing a medical device having a proximal end and a distal end into said body vessel such that the distal end of the medical device is disposed within said body vessel. The medical device defines a first lumen that extends along a first axis and a second lumen in fluid communication with the first lumen and that extends along a second axis disposed at an angle to the first axis. The first lumen has a proximal opening disposed at the proximal end of the medical device and a distal opening disposed at the distal end of the medical device. Another step comprises applying a suction force to the second lumen such that air from the environment external to said body vessel is pulled into the first lumen and through the second lumen. Another step comprises introducing a cannula having a proximal end and a distal end through the proximal opening of the first lumen such that the distal end of the cannula is disposed distal to the second lumen. Another step comprises introducing a wash fluid through the cannula such that the wash fluid exits the distal end of the cannula into said body vessel. Another step comprises continuing the step of introducing the wash fluid through the cannula until the wash fluid rises within the first lumen to a level sufficient for the suction force to pull the wash fluid into the second lumen. Another step comprises after the wash fluid achieves a level within the first lumen sufficient for the suction force to pull the wash fluid into the second lumen, continuing the step of applying a suction force to the second lumen such that the wash fluid is drawn through the second lumen. 
         [0008]    Another exemplary method of removing an impediment in a body vessel of a patient comprises introducing a medical device having a proximal end and a distal end into said body vessel such that the distal end of the medical device is disposed within said body vessel. The medical device comprising a pass-through fitting, a first sheath, and a second sheath. The pass-through fitting defines a main body and a side arm. The main body has a first inner wall that defines a first lumen that extends along a first axis and the side arm has a second inner wall that defines a second lumen in fluid communication with the first lumen and that extends along a second axis disposed at an angle to the first axis. The first lumen has a proximal opening disposed at the proximal end of the medical device and a distal opening disposed at the distal end of the medical device. The first sheath is connected to the main body and is in fluid communication with the first lumen. The second sheath is attached to the side arm and is in fluid communication with the second lumen. Another step comprises applying a suction force to the second lumen such that air from the environment external to said body vessel is pulled into the first lumen and through the second lumen. Another step comprises introducing a cannula having a proximal end and a distal end through the proximal opening of the first lumen such that the distal end of the cannula is disposed distal to the second lumen. Another step comprises introducing a wash fluid through the cannula such that the wash fluid exits the distal end of the cannula into said body vessel. Another step comprises continuing the step of introducing the wash fluid through the cannula until the wash fluid rises within the first lumen to a level sufficient for the suction force to pull the wash fluid into the second lumen. Another step comprises after the wash fluid rises within the first lumen to a level sufficient for the suction force to pull the wash fluid into the second lumen, continuing the step of applying a suction force to the second lumen such that the wash fluid is drawn through the second lumen. 
         [0009]    Various exemplary medical devices are also described and illustrated herein. 
         [0010]    An exemplary medical device comprises a pass-through fitting, a first sheath, a second sheath, and a cannula. The pass-through fitting defines a main body and a side arm. The main body has a proximal end, a distal end, and a first inner wall that defines a first lumen that extends along a first axis. The side arm has a second inner wall that defines a second lumen in fluid communication with the first lumen and that extends along a second axis disposed at angle to the first axis. The first lumen has a proximal opening disposed at the proximal end of the main body and a distal opening disposed at the distal end of the main body. The first sheath is connected to the main body and is in fluid communication with the first lumen. The second sheath is connected to the side arm and is in fluid communication with the second lumen. The cannula has a proximal end and a distal end disposed through the proximal opening of the first lumen such that the distal end of the cannula is disposed distal to the second lumen and a first fluid path is formed between the first inner wall and the cannula. A wash fluid passed through the proximal end of the cannula exits the distal end of the cannula. A suction force applied to the second lumen pulls the wash fluid exiting the distal end of the cannula into the second lumen or pulls fluid from the external environment through the proximal opening of the first lumen and into the second lumen. 
         [0011]    Additional understanding of these exemplary medical devices and methods can be obtained with review of the detailed description, below, and the appended drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]      FIG. 1  is an exploded view of a first exemplary medical device. 
           [0013]      FIG. 1A  is a magnified view of the area indicated in  FIG. 1 . 
           [0014]      FIG. 2  is a sectional view of the medical device illustrated in  FIG. 1 , taken along line  2 - 2 . 
           [0015]      FIG. 3  is a sectional view of the medical device illustrated in  FIG. 1 , taken along line  3 - 3 . 
           [0016]      FIG. 4A  is a side view of the medical device illustrated in  FIG. 1 , illustrating fluid flow through a fluid path of the device during a first stage of use. 
           [0017]      FIG. 4B  is a side view of the medical device illustrated in  FIG. 1 , illustrating fluid flow through a fluid path of the device during a second stage of use. 
           [0018]      FIG. 4C  is a side view of the medical device illustrated in  FIG. 1 , illustrating fluid flow through a fluid path of the device during a third stage of use. 
           [0019]      FIG. 5  is a flowchart illustration of a method of performing lithotripsy. 
           [0020]      FIG. 6  is a flowchart illustration of a second method of performing lithotripsy. 
       
    
    
     DETAILED DESCRIPTION 
       [0021]    The following detailed description and the appended drawings describe and illustrate various exemplary demonstration apparatuses, kits and methods. The description and drawings are exemplary in nature and are provided to enable one skilled in the art to make and use one or more exemplary apparatus, kit and/or to practice one or more exemplary method. They are not intended to limit the scope of the claims in any manner. 
         [0022]      FIGS. 1, 1A, 2, 3, 4A, 4B, and 4C  illustrate an exemplary medical device  10 . The medical device  10  includes a pass-through fitting  12  defining a main body  14  and a side arm  16 . A first sheath  18  is attached to the main body  14  and a second sheath  20  is attached to the side arm  16 . In the illustrated embodiment, an optional scope  70  comprising a handle  72  and first  74  and second  76  cannula is associated with the medical device  10 . The scope has a proximal end at, or near, handle  72  and a distal end at the end of the cannula opposite that connected to the handle. Thus, the cannula extends from the handle to the distal end of the scope. 
         [0023]    The main body  14  has a first inner wall  22  that defines a first lumen  24  extending along a first axis  26  of the medical device  10 . Similarly, the side arm  16  has a second inner wall  28  that defines a second lumen  30  that extends along a second axis  32  of the medical device  10 . The second axis  32  is disposed at an angle to the first axis  26 . That is, the second axis  32  intersects the first axis  26 . The axes  26 ,  32  can be disposed at any suitable angle, and a skilled artisan will be able to select an appropriate angle for a medical device according to a particular embodiment based on various considerations, including the nature of the body vessel within which the medical device is intended to be used. A structure in which the axes  26 ,  32  lie on the same plane and intersect at a substantially orthogonally is considered suitable. Additional example angles considered suitable for a second axis to intersect a first axis include, but are not limited to, a 45 degree angle, a substantially 45 degree angle, any angle between 0 degrees and 45 degrees, any angle between 45 degrees and 90 degrees, a 90 degree angle, a substantially 90 degree angle, 135 degree angle, a substantially 135 degree angle, any angle between 135 degrees and 180 degrees, and any other angle considered suitable for a particular application. 
         [0024]    While one side arm  16  has been illustrated and described, pass-through fitting  12  can define any suitable number of side arms, and skilled artisans will be able to select a suitable number of side arms for a pass-through fitting to define according to a particular embodiment based on various considerations, including the procedure intended to be performed. Example number of side arms considered suitable for a pass-through fitting to define include, but are not limited to, one, at least one, two, a plurality, three, four, and any other number considered suitable for a particular application. 
         [0025]    The first  24  and second  30  lumens are in fluid communication with each other to define a branched flow path  34  through the pass-through fitting  12 . The branched flow path  34  defines two paths along which fluid can flow through the main body  14  and into the side arm  16 . For the first path, fluid flows through a proximal opening  36  defined by the proximal end  38 , into the first lumen  24  and then into the second lumen  30 . For the second path, fluid flows through a distal opening  40  defined by the distal end  42 , into the first lumen  24  and then into the second lumen  30 . For each flow path, fluid can also flow in the reverse direction. 
         [0026]    The first sheath  18  defines a first sheath lumen  44  and the second sheath  20  defines a second sheath lumen  46 . The first sheath  18  is attached to the main body  14  in any suitable manner such that the first sheath lumen  44  is in fluid communication with the first lumen  24  of the main body  14 . Similarly, the second sheath  20  is attached to the side arm  16  in any suitable manner such that the second sheath lumen  46  is in fluid communication with the second lumen  30  of the side arm  16 . With this arrangement, the sheaths  18 ,  20  further extend the branched flow path  34  defined by the first  24  and second  30  lumens of the pass-through fitting  12 . The inner diameter of the first lumen  24 , second lumen  30 , and the second sheath lumen  46  may be greater than the inner diameter of the first sheath lumen  44  at the proximal end of the first sheath  18  to ensure fragments traveling through first sheath  18  can pass through first lumen  24 , second lumen  30 , and the second sheath lumen  46 . 
         [0027]    Each sheath  18 ,  20  can be attached to the pass-through fitting  12  in any suitable manner, such as by adhesives, mechanical connectors, clamps, and any other suitable structure or component for attaching a sheath to a fitting. Furthermore, one or both of the sheaths  18 ,  20  can define additional structure that facilitates its attachment to the pass-through fitting. For example, as best illustrated in  FIG. 1 , the first sheath  18  can define a flared proximal end  48  that facilitates its attachment to the pass-through fitting  12 . In this embodiment, a locking connector  50  that defines a locking connector lumen  51  can be placed over the flared proximal end  48  to secure the first sheath  18  to the pass-through fitting  12 . The locking connector  50  can define threads or other suitable structure that mates with complimentary structure on the pass-through fitting to for a connection that holds the first sheath  18  in a captive position. 
         [0028]    In use, a suction force applied to the second lumen  30  of the side arm  16  pulls fluid from the first lumen  24  of the main body  14  and into the second lumen  30 . With the attached sheaths  18 ,  20 , a suction force applied to the second sheath lumen  46  of the second sheath  20  is able to pull fluid that has reached the point in the first lumen  24  of the main body  14  that intersects with the second lumen  30 , such as fluid that has been forced upward through the first sheath lumen  44  as a result of pressure build up from continued introduction of fluid into a blind body vessel of limited elasticity, as described more fully below. Once this fluid level is achieved, the fluid enters the second lumen  30  of the side arm  16 , and eventually into the second sheath lumen  46 . Because of the branched flow path  34 , fluid can also enter the first lumen of the main body  14  through the opening  36  defined by the proximal end  38  of the main body  14 . As described more fully below, these alternate routes of entry into the first lumen  24  enable the medical device  10  to apply a suction force during a lithotripsy procedure in a controlled manner. 
         [0029]    The medical device  10  can include various additional components, such as a valve  52  attached to the second sheath  20 . The valve  52  offers a control for selectively establishing fluid communication between the second sheath lumen  46  and a downstream component, such as a source of a suction force. If included, the valve  52  can be a part of a larger fitting that defines additional structure. For example, a valve fitting that includes additional ports can be included. In this embodiment, the valve is adapted to selectively establish fluid communication between the second sheath lumen  46  and one of its multiple ports. 
         [0030]    As illustrated in  FIG. 1 , a proximal cap member  54  can be attached to the main body  14 . If included, the proximal cap member  54  can be attached in any suitable manner, such as with an adhesive, a mechanical structural connection such as mating threads or a snap fit, or other suitable means for connecting two structures. Also, the proximal cap member  54  should define an opening  55  and lumen  56  that provide fluid access to the opening  36  defined by the main body  14 . As such, the inclusion of the proximal cap member  54  doesn&#39;t eliminate the branched flow path  34 . 
         [0031]    A valve can be attached to the proximal cap member  54  and adapted to block fluid flow from the external environment into the first lumen  24 . Any suitable valve can be used for valve  52  and/or the valve attached to the proximal cap member  54 . Skilled artisans will be able to select a suitable valve according to a particular embodiment based on various considerations, including the treatment desired to be performed. 
         [0032]    Advantageously, a device used with the medical device  10 , such as scope  70 , defines structure that allows it or a portion of it to be extended through the first lumen  24  in a manner that does not block fluid flow from the external environment into the first lumen  24 . For example, as illustrated in  FIG. 1 , the first  74  and second  76  cannula of scope  70  can be extended through the first lumen  24  of the pass-through fitting  12  and into the first sheath lumen  44  without forming a seal or other block to fluid flow into the opening  36  of the pass-through fitting  12  from the external environment. Each of the first  74  and second  76  cannula of scope  70  defines a lumen that extends along the length of the cannula. This structural arrangement allows the medical device  10  to define two paths along which fluid can flow through the main body  14  and into the side arm  16 . While the illustrated scope  70  is considered suitable, its specific structure is not considered necessary, and any suitable scope can be used with the medical device  10  and in the methods and kits described herein. For example, while the illustrated scope  70  includes first  74  and second  76  cannula that are attached or bonded together, a unitary structure that defines two independent lumens could also be used (e.g., a cannula that defines more than one lumen). 
         [0033]    While using a scope  70  with medical device  10  has been illustrated and described, any suitable medical device can be used with medical devices described herein, and skilled artisans will be able to select a suitable medical device to use with the medical devices described herein according to a particular embodiment based on various considerations, including the treatment desired to be performed. Example medical devices considered suitable to use with the medical devices described herein include, but are not limited to, probes, scopes, cutting tools, elongate tubular members, suction devices, irrigation devices, graspers, forceps, lithotripters, balloons, drills, lasers, baskets, and any other medical device considered suitable for a particular application. 
         [0034]    The proximal opening of the first sheath  18  may have a larger inner diameter than the distal portion of the first sheath  18  to ensure that fluid is not drawn up from the distal lumen as devices are inserted into the first sheath  18 . This ensures fluid is only drawn into the second lumen  30  when the fluid level in the first lumen  24  is forced up to the level of the second lumen  30 . Similarly, the proximal portion of the first lumen  24  may have a larger inner diameter than the distal portion of the first lumen  24 . In addition, the cross-sectional area of the second lumen  30  can be equal to, substantially equal to, or greater than, the cross-sectional area of the first lumen  24 , or the cross-sectional open area of the first lumen  24  external to the medical device when the first lumen contains a medical device, such as scope  70 . Alternatively, the inner diameter of the second lumen  30  can be equal to, substantially equal to, or greater than, the inner diameter of the first lumen  24 . These structural features can be included separately or in combination with each other. 
         [0035]    Additional structure can include the attachment of a tapered fitting which is connected to the opposite end of second sheath  20  than the end that is attached to the pass-through fitting  12 . This tapered fitting can be inserted into a vacuum line to facilitate connection to the vacuum source. 
         [0036]      FIGS. 4A, 4B, and 4C  illustrate the medical device  10  in various stages of use, such as during performance of one of the methods described below. The figures illustrate the introduction of a wash fluid into the associated scope  70  and the travel of the flow of the fluid through a fluid path of the device  10  during the various stages of use. In each of the figures, the relatively light line  90  represents the overall fluid path and the relatively dark line  92  represents the portion of the fluid path along which fluid has flown at the illustrated stage of use. 
         [0037]      FIG. 4A  illustrates a first stage of use. In this stage, the wash fluid has been introduced into the scope  70  through a side port  78  that is in fluid communication with a cannula  76  (one of the two cannulae  74 ,  76  of the scope  70 ). Alternatively, if a cannula that defines more than one lumen is being used, the wash fluid can be introduced into one of the lumens defined by the cannula through a side port that is in fluid communication with the lumen. The pressure supplied by the continued introduction of the fluid into the side port  78  has forced the fluid along the fluid path  90 , but the fluid has not yet exited the first sheath  18  attached to the pass-through fitting  12 . At this stage, a suction force applied to the second sheath  20  draws air from the external environment through the opening  36  defined by the proximal end  38  of the main body  12 , and through the opening defined by the proximal cap member  54 . The air enters the first lumen  24  defined by the main body  14 , and subsequently enters the second lumen  30  defined by the side arm  16 . Ultimately, the air continues through the second sheath  20  toward the source of the suction force. This is possible because of the branched flow path  34  and prevents the suction force from being applied to the empty body vessel, which might otherwise damage the vessel or hinder visualization by the scope by inducing collapse. 
         [0038]      FIG. 4B  illustrates a second stage of use. In this stage, which follows the stage illustrated in  FIG. 4A , the pressure supplied by the continued introduction of the fluid into the side port  78  has forced the fluid further along the fluid path  90 . The fluid has exited the distal end of the first sheath  18  and entered the lumen defined by the body vessel. The blind nature of the salivary duct forces the fluid to re-enter the sheath  18  as it seeks the path of least resistance with continued introduction of fluid. The fluid has not, however, reached the second lumen  30  defined by the side arm  16 . As a result, the suction force applied to the second sheath  20  continues to draw air from the external environment through the opening  36  defined by the proximal end  38  of the main body  12 , and through the opening defined by the proximal cap member  54 . As in the first stage illustrated in  FIG. 4A , the air continues to enter the first lumen  24  defined by the main body  14 , and continues to enter the second lumen  30  defined by the side arm  16 . Ultimately, the air continues through the second sheath  20  toward the source of the suction force. Also similar to the first stage, the branched flow path  34  continues to prevent the suction force from being applied to the empty body vessel, which might otherwise damage the vessel by inducing collapse. In this stage, an impediment from the vessel, or fragments of an impediment, can travel with the fluid through the first sheath  18  external to the cannula  74 ,  76  of the scope  70 . Alternatively, if a cannula that defines more than one lumen is being used, the impediment from the vessel, or fragments of an impediment, can travel with the fluid through the first sheath  18  external to the cannula. 
         [0039]      FIG. 4C  illustrates a third stage of use. In this stage, which follows the stage illustrated in  FIG. 4B , the pressure supplied by the continued introduction of the fluid into the side port  78  has forced the fluid further along the fluid path  90 . The fluid has reached the second lumen  30  defined by the side arm  16  in the pass-thorough fitting  12 . As a result, the suction force applied to the second sheath  20  has begun to draw the fluid through the second lumen  30  of the side arm  16  and into the second sheath  20 . In the pass-through fitting  12 , the fluid has partially or completely sealed the second lumen  30  from the air entering the main body  14 . In this stage, the suction pulls the fluid and impediments or fragments of an impediment through the second sheath  20 , which can be collected as waste. 
         [0040]    The medical devices are particularly well-suited for use in methods of removing impediments from body vessels. For example, the medical devices can be used in methods of performing lithotripsy in a salivary duct. For example, to fragment and/or remove a stone disposed within a salivary duct. The medical devices described herein can be used to treat any suitable body vessel and/or bodily passage, and skilled artisans will be able to select a suitable body vessel and/or bodily passage to treat using a medical device described herein based on various considerations, including the treatment intended to be performed. Example body vessels and/or bodily passages considered suitable include, but are not limited to, a salivary duct, urinary tract, and any other body vessel and/or bodily passage considered suitable for a particular embodiment. 
         [0041]    Various methods of removing an impediment in a body vessel are provided. While the methods described herein are shown and described as a series of acts, it is to be understood and appreciated that the methods are not limited by the order of acts, as some acts may, in accordance with these methods, occur in different orders, and/or concurrently with other acts described herein. 
         [0042]      FIG. 5  is a flowchart representation of a first exemplary method  200  of removing an impediment in a body vessel of a patient. This first exemplary method is useful for addressing impediments in body vessels that might be able to be removed without disruption of the structure of the impediment. 
         [0043]    A first step  202  comprises introducing a medical device into the body vessel. The medical device is a medical device according to an embodiment of the invention, such as the medical device  10  illustrated in  FIG. 1  and described above. Thus, a medical device can be introduced into the body vessel such that the distal end of the medical device, or the distal end of the first sheath, is disposed in the body vessel. 
         [0044]    A second step  204  comprises applying a suction force to the second lumen of the medical device such that air from the environment external to the body vessel is pulled into the first lumen and through the second lumen. 
         [0045]    A third step  206  comprises inserting a cannula having a proximal end and a distal end through the first lumen such that the distal end of the cannula is disposed distal to the second lumen. As described above, the cannula is inserted through the first lumen without forming a seal or otherwise blocking air or fluid flow into the first lumen from the external environment. An optional step comprises inserting a cannula having a proximal end and a distal end through the first lumen such that the distal end of the cannula is disposed distal to the distal end of the medical device. 
         [0046]    A fourth step  208  comprises introducing a wash fluid through the cannula and into said body vessel such that the wash fluid exits the distal end of the cannula into said body vessel. 
         [0047]    A fifth step  210  comprises continuing the step of introducing the wash fluid through the cannula until the wash fluid enters the first lumen to a level sufficient for the suction force to pull the wash fluid into the second lumen. Any level sufficient for the suction force to pull the wash fluid into the second lumen is considered suitable. Levels considered suitable include, but are not limited to, a level within the first lumen equal with the second lumen, a level within the first lumen along the diameter of the second lumen, a level within the first lumen and along the length of the first lumen, a level within the first lumen and disposed at the distal intersection between the first lumen and second lumen, a level within the first lumen and disposed at the proximal intersection between the first lumen and second lumen, and any other level considered suitable for a particular application. 
         [0048]    A sixth step  212  comprises continuing the step of applying a suction force to the second lumen after the wash fluid achieves a level within the first lumen sufficient for the suction force to pull the wash fluid into the second lumen such that the wash fluid is drawn through the second lumen. 
         [0049]    An optional step comprises removing the cannula from said body vessel by withdrawing the cannula through the first lumen such that the distal end of the cannula is disposed proximal to the proximal opening of the first lumen. Another optional step comprises removing the medical device from the body vessel such that the distal end of the medical device is free of the body vessel. 
         [0050]    While various steps, alternative steps, and optional steps have been described above with respect to removing an impediment in a body vessel, these steps, alternative steps, and optional steps can be included in, accomplished concurrently with, and/or accomplished in the alternative to, the methodologies, steps, alternative steps, and/or optional steps described below with respect to the exemplary method  300  of removing an impediment in a body vessel. 
         [0051]      FIG. 6  is a flowchart representation of another exemplary method  300  of removing an impediment in a body vessel of a patient. This exemplary method is useful for addressing impediments in body vessels that may require disruption of the structure of the impediment prior to removal from the body vessel. 
         [0052]    A first step  302  comprises introducing a medical device into the body vessel. The medical device is a medical device according to an embodiment of the invention, such as the medical device  10  illustrated in  FIG. 1  and described above. Thus, a medical device can be introduced into the body vessel such that the distal end of the medical device, or the distal end of the first sheath, is disposed in the body vessel. 
         [0053]    Another step  304  comprises applying a suction force to the second lumen of the medical device such that air from the environment external to the body vessel is pulled into the first lumen and through the second lumen. 
         [0054]    Another step  306  comprises inserting a scope having a handle and first and second cannula through the first lumen such that the distal end of each cannula extends axially beyond the second lumen in the body vessel. Alternatively, a cannula that defines more than one lumen can be used. Therefore, step  306  can comprise inserting a scope comprising a proximal end, a distal end, a handle, and a cannula extending from the handle to the distal end of the scope through the proximal opening of the first lumen such that the distal end of the scope is disposed distal to the second lumen. As described above, the cannula is inserted through the first lumen without forming a seal or otherwise blocking fluid flow into the first lumen from the external environment. An optional step comprises inserting a scope comprising a proximal end, a distal end, a handle, and a cannula extending from the handle to the distal end of the scope through the proximal opening of the first lumen such that the distal end of the scope is disposed distal to the distal end of the medical device. 
         [0055]    Another step  308  comprises introducing a lithotripter into one of the cannulae of the scope. Alternatively, a cannula that defines more than one lumen can be used. Therefore, step  308  can comprise introducing a lithotripter having a proximal end and a distal end into a cannula. Any suitable lithotripter can be used, including a laser lithotripter, an ultrasonic lithotripter, and a pneumatic lithotripter. 
         [0056]    Another step  310  comprises passing the lithotripter through the cannula until a distal end of the lithotripter is disposed in the body vessel at an effective distance from the impediment to be removed from the body vessel. The effective distance should be selected based on the type of lithotripter being used, and may include direct contact between the lithotripter and the impediment, which is considered an effective distance for a pneumatic lithotripter, or a measured distance between the distal end of the lithotripter and the impediment. 
         [0057]    Another step  312  comprises activating the lithotripter to disrupt the structure of the impediment (e.g., stone) to form one or more fragments (e.g., stone fragments). 
         [0058]    Another step  314  comprises introducing a wash fluid into the other cannula of the scope (i.e., the cannula that does not contain the lithotripter). Alternatively, a cannula that defines more than one lumen can be used. Therefore, the wash fluid can be introduced into the other lumen of the cannula (i.e., the lumen that does not contain the lithotripter). Any suitable wash fluid can be used, including saline and other wash and/or rinse fluids considered acceptable for use in medical procedures. It is noted that the step of introducing wash fluid can be conducted at any time during the method and for any duration. For example, in the case of sialendoscopy, the fluid is introduced from the beginning in order to dilate the duct and to aid in visualization. Optionally, the fluid is constantly injected during the entire time the scope is in place. For example, a step comprising continuing the step of introducing the wash fluid through the cannula until the wash fluid rises within the first lumen to a level sufficient for the suction force to pull the wash fluid into the second lumen can be performed while the step of activating the lithotripter to disrupt the structure of said impediment is being performed. 
         [0059]    Another step  316  comprises continuing the step of applying a suction force until the wash fluid is drawn into the first fluid path and into the second lumen. This step is dependent on the method being conducted in a blind vessel, such as the salivary ducts. The blind nature of these vessels forces the wash fluid to re-enter the first lumen of the medical device as more fluid is introduced and the fluid seeks the path of least resistance. As the wash fluid re-enters the first lumen and, ultimately, enters the second lumen, the air flow from the external environment into the first lumen is blocked and the suction force begins drawing the wash fluid, and the fragments of the impediment, through the second lumen. The fragments and wash fluid can be collected as waste. 
         [0060]    Various optional steps can be included, if desired. For example, to air in the removal of larger fragments of the impediment, another step  318  comprises removing the scope from the body vessel by withdrawing the cannulae through the first lumen of the pass-through fitting. Alternatively, a cannula that defines more than one lumen can be used. Therefore, step  318  can comprise removing the scope from the body vessel by withdrawing the cannula of the scope through the first lumen of the pass-through fitting such that the distal end of the scope is disposed proximal to the proximal opening of the first lumen. Following removal of the scope, another step  320  comprises introducing a catheter, such as a single lumen catheter, through the first lumen of the pass-through fitting and into the body vessel and then infusing wash fluid through the catheter, forcing fragments of the impediment up through the first lumen and then into the second lumen. At this point, relatively large fragments can exit the vessel by travelling through the lumen of the catheter. Following removal of the scope, another step  322  comprises continuing the step of applying a suction force until the wash fluid is drawn into the first fluid path and into the second lumen. Another optional step comprises removing the lithotripter from the body vessel by withdrawing the lithotripter from the scope through the cannula such that the distal end of the lithotripter is disposed proximal to the proximal end of the scope. 
         [0061]    If additional disruption of the impediment is needed, steps  306  through  316  can be repeated a suitable number of times, with or without inclusion of the steps of removing the scope and introducing a catheter during each cycle. 
         [0062]    It is also possible to use the single lumen catheter to flush fragments up through the first lumen and the stone fragments collect at the cap near the opening of the second lumen. In this case, the suction would be stopped and fluid injected from a port located at the valve on the second sheath. The valve is turned such that the suction is occluded and the side arm is in communication with the second lumen. Thus, when fluid is injected into the second sheath, it is passed back up the second lumen of the side arm, into the cap and into the first lumen of the main body to flush the stones out of the first lumen through the proximal opening. For example, referring to the medical device illustrated in the Figures, the suction may be occluded with valve  52  and fluid injected through an additional port located at valve  52  to travel through the second sheath lumen  46  and into the out proximal opening  36 . This action moves impediments from the body of the sheath and the medical device  10 . An alternative method to clear any fragments which may collect in the body of the sheath is to occlude suction with valve  52  and continue to infuse wash fluid through the irrigation catheter which forces flow through opening  36  which carries any impediments which collect at the body of the sheath out of the body of the sheath. 
         [0063]    While various steps, alternative steps, and optional steps have been described above with respect to removing an impediment in a body vessel, these steps, alternative steps, and optional steps can be included in, accomplished concurrently with, and/or accomplished in the alternative to, the methodologies, steps, alternative steps, and/or optional steps described above with respect to the exemplary method  200  of removing an impediment in a body vessel. 
         [0064]    Kits are also provided. An exemplary kit comprises a medical device according to an embodiment, such as the medical device  10  illustrated in  FIG. 1 ; and any one or more of the following: a scope, such as scope  70  illustrated in  FIG. 1 ; a scope having a cannula defining one or more lumens, a wire guide, a lithotripter, and an irrigation catheter. If included, the lithotripter can comprise any suitable lithotripter, such as a laser lithotripter, an ultrasonic lithotripter, and or pneumatic lithotripter. The lithotripter is sized and configured to be used with the medical device. As such, it includes a probe that is sized and configured to be capable of being passed into and substantially through the cannula of the scope. 
         [0065]    In all embodiments, the medical device and, with kits, the components can be formed of any suitable materials and a skilled artisan will be able to select appropriate materials based on various considerations, such as a desired appearance, reuseability, and other considerations. The materials selected need only be considered safe for use in medical devices not intended for long term implantation. Examples of suitable materials include conventional plastic and metal materials commonly used in medical devices, and later-developed materials that become considered acceptable for such use. 
         [0066]    The foregoing detailed description refers to exemplary occlusion devices and includes the best mode for practicing the invention. The description and the appended drawings illustrating the described devices are intended only to provide examples and not to limit the scope of the claims in any manner.