Abstract:
A device for insertion into a body lumen includes an operator unit which may be hand held by an operator. A cannula is operatively associated with the operator unit and the cannula includes two parallel lumens. At least one of two lumens terminates at its distal end before the distal end of the other lumen and wherein one of the two lumens is contained at most partially within the other lumen.

Description:
RELATED APPLICATIONS 
       [0001]    This application is related to and claims priority to U.S. Provisional Application No. 61/927426, filed Jan. 14, 2014, the entirety of which is herein incorporated by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    This invention relates to medical devices and in particular to devices which are adapted to fragment materials contained within a body lumen, including urinary tract stones, bladder stones, kidney stones and the like, using optical energy, especially lasers, and removing fragmented materials from the body lumen. 
       BACKGROUND 
       [0003]    Medical devices which are used to fragment and remove stones and other materials from, for example, the urinary tract, the bladder and the kidneys (hereinafter referred to as “stones”), are known in the art. An example of such a device is shown in U.S. Pat. No. 6,517,531. In this patent, a dual lumen elongated member is used, respectively, for the purposes of providing a first lumen for an optical fiber and a second lumen to aspirate fragmented stones or other materials. 
         [0004]    One of the problems associated with the foregoing patent as well as other prior art is that a balance must be struck between the overall size or diameter of the device to be introduced into the urinary tract of a human being and to fit the working channel of an urethascope. The size should preferably be chosen not only so that it will fit within the space constraints above but also be of a size to be able to incorporate an aspiration lumen as well as a lumen to contain an optical fiber which is used to break apart, in this example, stones or other materials in urinary tract. As can be seen,  FIG. 1  represents the prior art and it can be seen that the optical fiber lumen is contained within the aspiration lumen. This arrangement, of course, decreases the size of the aspiration lumen and limits the size of the degree of the stones or other fragmented materials which can be suctioned through the aspiration lumen to outside the body. Both  FIGS. 1A and 1B  show two variations of prior art systems which include the optical fiber lumen within the aspiration lumen. Thus, there is a need for a two lumen device which maintains the maximum size of the aspiration lumen so that larger pieces of fragmented stones or other materials may be aspirated while still containing sufficient space for the optical fiber lumen. 
         [0005]    Another problem associated with dual lumen devices of the type of the present invention is that, as can be seen in prior art  FIGS. 1A and 1B , the fiber lumen and the aspiration lumen terminate at the same plane. This results in the inability of the physician or other operator to visualize the optical fiber tip unless it is pushed out of the optical lumen. In a known procedure, in addition to the use of the device such as is described in the above patent and in the present invention an additional device named a urethascope is positioned in the body lumen and provides, among other things, a visualization lumen to the physician to visualize the materials sought to be removed and to guide the optical fiber. It is also known that during the process and procedure of fragmenting stones and other materials that the tip of the optical fiber may itself fragment due to the intense energy delivered through and at the tip of the optical fiber. Because the optical fiber lumen and the plane of the aspiration lumen terminate at the same plane, it is often difficult for the physician to inspect the tip of the optical fiber. Thus, what is needed is a dual lumen device which allows for easy visualization of the optical fiber tip. 
         [0006]    Another issue associated with such devices described in the above patent and the present invention is the control of the optical fiber into the body cavity and its advancement within the body cavity to stones or other materials which are sought to be fragmented. Thus, what is needed is a simple and accurate means to move and control the position of the optical fiber and its tip in the urinary tract to better be able to aim the optical fiber tip at the stones to be fragmented. 
         [0007]    Yet another issue associated with such devices is the ability to provide a handpiece that is easily gripped and manipulated by the operator of the device in use and which provides all controls for various functions, such as advancement of the optical fiber at gross movement levels and fine movement levels and control over the function of aspiration and irrigation within easy reach of the operator during a procedure. 
       SUMMARY OF THE INVENTION 
       [0008]    In an aspect, a device for insertion into a body lumen includes an operator unit adapted to be held by an operator; a cannula operatively associated with the operator unit. The cannula includes at least two parallel lumens. At least one of the at least two lumens terminates at its distal end before the distal end of the other of the at least two lumens. 
         [0009]    In another aspect, the at least one lumen which terminates before the distal end of the other of the at least two lumens is contained at most partially within the at least one other lumen which extends beyond the distal end of the at least one lumen which terminates before the distal end of the at least two lumens. 
         [0010]    In yet another aspect, a device for insertion into a body lumen includes an operator unit adapted to be held by an operator; a cannula operatively associated with the operator unit. The cannula includes at least two parallel lumens. The at least two lumens is contained at most partially within the at least one other lumen. 
         [0011]    In a further aspect, the cannula is operatively associated with the operator unit at the proximal end of the cannula. 
         [0012]    In yet another aspect, one of the at least two parallel lumens is adapted for receiving an optical fiber and the other of the at least two parallel lumens is adapted for one or more of aspiration and irrigation of materials within the body lumen. 
         [0013]    In yet a further aspect, the operator unit includes one or more controls to manipulate one or more of the optical fiber and the one or more of the aspiration and irrigation of materials within the body lumen. 
         [0014]    In yet a further aspect, the at least one lumen terminating before the distal end of the other of the at least two lumens is wholly outside of the other of the at least two lumens. 
         [0015]    In an aspect, the control to manipulate the optical fiber includes a wheel operatively associated with the operator unit which one of directly or indirectly engages the optical fiber to advance the optical fiber within the operator unit. Furthermore, at least two rollers are operatively connected with the wheel, the at least two rollers being engageable with the optical fiber therebetween and wherein movement of the wheel causes the optical fiber to move due to contact with the moving at least two rollers. At least one of the at least two rollers is of a resilient material. 
         [0016]    In another aspect, the control to manipulate the optical fiber includes a mechanism to disengage the wheel from the optical fiber such that the operator may manually advance the optical fiber. 
         [0017]    In yet another aspect, the one or more controls for one or more of aspiration and irrigation of materials includes a mechanical switch and a flexible tube operatively associated with the mechanical switch, wherein the mechanical switch, when depressed, engages and at least partially collapses the flexible tube to stop one of: aspiration or irrigation of materials in the body lumen. 
         [0018]    In a further aspect, the mechanism includes a tube for containing the optical fiber, and wherein the tube is movable from a first position to a second position, in the second position being interposed between the at least two rollers such that an optical fiber within the tube is not engaged with the at least two rollers and may be advanced by the operator without movement of the wheel. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0019]      FIGS. 1A and 1B  illustrate prior art dual lumen apparatuses. 
           [0020]      FIG. 2  illustrates overall views of the apparatus of the present invention. 
           [0021]      FIG. 3  illustrates the distal portion of a dual lumen elongated device of the present invention. 
           [0022]      FIGS. 4A to 4C  illustrate other embodiments of the device illustrated in  FIG. 3 . 
           [0023]      FIG. 4D  illustrates another view of a prior art device. 
           [0024]      FIG. 5  illustrates an exploded view of the handpiece of the present invention. 
           [0025]      FIGS. 6 and 7  illustrate the handpiece and the contained mechanisms for advancing an optical fiber and controlling an aspiration/irrigating apparatuses. 
           [0026]      FIGS. 8A ,  8 B,  9 A and  9 B illustrate two of the devices for controlling the insertion and advancement of an optical fiber into the optical fiber lumen. 
           [0027]      FIGS. 10A to 10H  illustrate the overall design of the handpiece. 
       
    
    
     DETAILED DESCRIPTION 
       [0028]    Turning now to  FIG. 2 , this figure illustrates the overall structure of the device of the present invention. This can be seen as a handpiece  10 , which will be described in greater detail below, having a cannula  12  with at least two lumens, the first lumen for the aspiration and irrigation of materials and the second a lumen for containing and guiding an optical fiber. The handpiece  10  also contains controls  14  as seen in  FIG. 2  and as will be described below in detail in reference to  FIGS. 7 to 9  below, to control the aspiration/irrigating means as well as the advancement of the optical fiber. Thus, in  FIG. 2 , the proximal end of the handpiece  10  includes an optical fiber port  16  and a vacuum port  18 , to be described below. In addition, a removable pin  20  is included to control the release of the mechanical vacuum switch, to be described below. 
         [0029]    The cannula  12  may be constructed of any number of materials including metal. While the cannula  12  is shown as being more or less orthogonal to the handpiece  10 , it is feasible to orient the angle between the handpiece  10  and the cannula  12  in any desired angle. The shape of the handpiece is ergonomically designed to allow easy handling and operation of the handpiece during a procedure.  FIGS. 10A through 10H  provide additional various views of the handpiece  10 . 
         [0030]    Turning now to  FIG. 3 , that figure illustrates another aspect of the present invention. As can be seen in  FIG. 3 , the distal end of the cannula  12  includes the distal end of the optical fiber lumen  22  as well as the distal end  24  of the aspiration/irrigation lumen. It is noted that the cannula which encompasses both the fiber lumen and the aspiration/irrigation lumen may be made of a metal material or any other suitable material such as a polymeric material and may be translucent or even transparent depending on the use to which it will be put. It can be seen in  FIG. 3  that the distal end of the optical fiber lumen is not in the same plane as the distal end of the aspiration and irrigation lumen  24 . The distal end of the optical fiber lumen is set back from the plane of the distal end of the aspiration and irrigation lumen by a distance  26  and this is for the purpose of allowing better visualization by the operator of the distal tip of the optical fiber than would be feasible if the distal tip of the optical fiber lumen  22  terminated on the same plane as the aspiration/irrigation lumen  24 . The fiber tip and its jacket are very much visible to the physician during a procedure due to the “set back” of the optical fiber lumen, so that the position of the fiber tip and the condition of the fiber tip are readily viewable. Turning now to  FIGS. 4A  to  4 C, these figures illustrate a number of alternative embodiments of the relationship between the optical fiber lumen and the aspiration/irrigation lumen.  FIG. 4D  represents the prior art discussed above in reference to  FIGS. 1(   a ) and  1 ( b ). 
         [0031]      FIG. 4D  illustrates the relationship between the optical fiber lumen and the aspiration and irrigation lumen as seen in the prior art devices of  FIGS. 1A and 1B . In this embodiment, the optical fiber lumen is shown as being contained wholly within the aspiration/irrigation lumen. This results in a reduction in the maximum size of stones and other materials which may be aspirated through that lumen. For example, in the structure of the devices of prior art  FIGS. 1A ,  1 B and  1 D, if D is in diameter of the aspiration/irrigation lumen and d is the diameter of the optical fiber lumen, then the maximum stone or other material size which can be evacuated is D−d. However, in the devices illustrated in  FIGS. 4A to 4C , the maximum stone or other material size which can be evacuated is D−½d, thus allowing the aspiration of larger stones and other materials while maintaining the same overall diameter of the combined lumens as in the prior art devices. 
         [0032]      FIG. 5  illustrates the handpiece  10  of  FIG. 2  viewed from a perspective exploded view. The top section  11  of the handpiece  10  includes a wheel or roller control  30  which controls the advancement of the optical fiber. It also includes a mechanical switch  32  which controls the opening and the closing of the aspiration/irrigation lumen. It further includes a locking switch  34  which may be used to lock the aspiration/irrigation lumen in either an open or closed position to free the physician&#39;s fingers for other operations, such as manipulating the optical fiber to the vicinity of the stones or other materials which are thought to be fragmented by the optical fiber energy. Finally, a locking pin  35  is operatively connected to the mechanical switch to prevent activation of operation of the aspiration/vacuum function. A second optical fiber handling mechanism  36 , as can be seen in  FIG. 5  as  210  in  FIG. 9 , on the proximal portion of the handpiece provides further controls over the optical fiber advancement. 
         [0033]      FIGS. 6 and 7  illustrate different views of the mechanisms to which the controls  30 ,  32 ,  34  and  36  are connected. The mechanical switch  32  may have a stopper  40  which presses onto a silicone or other material flexible aspiration/irrigation tube  42  so that the aspiration/irrigation tube  42  may be in either a normally collapsed/closed position or moved to an open position. The lock mechanism  34  may be used to keep the aspiration/irrigation channel in an open position, the default position being the position in which the stopper  40  presses against the tube to keep it closed. The locking switch  34  may be designed in any number of desired default orientations: always off so that no vacuum is in operation unless actuated; always on so that the vacuum is always on unless the operator disengages the operation; and a mode in which the vacuum is turned on any time the laser is activated so that aspiration occurs while fragmenting stones. The locking pin  35  when inserted into handpiece, interacts with the mechanical switch  32  to either prevent its depression and the depression of the stopper  40  or to hold the stopper  40  against the tube  42  to prevent actuation of the vacuum/aspiration function. In order to use the mechanical switch  32 , the locking pin must be removed.  FIGS. 7 and 8  show the device  100  (or button  30  in  FIG. 5 ) positioned distally of the device  200  (or  36  in  FIG. 5 ). As will be detailed below, each of these devices accepts and is capable of advancing (or retracting for that matter) an optical fiber that is inserted in the proximal portion of the handpiece in the vicinity of the vacuum fitting  18  shown in  FIG. 2  as well. 
         [0034]    Now to be discussed is the operation and structure of the mechanisms  100  and  200  which are utilized to control and advance the position of the optical fiber. Turning now to  FIG. 8 , that figure shows the “main” mechanism for controlling and advancing an optical fiber controlled more or less precisely by the wheel or roller  102 . As can be seen the wheel or roller  102  is attached to a geartrain  104 ,  106  and  108  and that turning of the wheel or roller  102  will in turn cause rotation of shafts  110  and  112 . Shafts  110  and  112  have mounted on them two rollers  114  and  116 . There may be made of a resilient material and are spaced a distance that is slightly apart but sufficiently close that an optical fiber placed therebetween is constrained against movement or is moveable by rotation of the wheel or roller  102  and through geartrain  106  and  108 . Distally of the rollers  114  and  116  is a curved tube  120 . The tube  120  receives an optical fiber that has passed through the rollers  114  and  116 . The distal end of the tube  120  is connected to or at least in the vicinity of opening  37  (best shown in  FIG. 5 ). Thus, an optical fiber advanced through the device  100  under action of the wheel or roller  102  will exit the distal end of tube  120  and enter the lumen  39  which constitutes the fiber lumen as shown in  FIGS. 3 and 5 . 
         [0035]    Turning now to  FIG. 9 , that figure illustrates the assembly  200  assembled towards the proximal portion of the handpiece  10  as may be seen in  FIG. 6 . An entry port  202  best seen in the exploded view of  FIG. 9A  includes a tube section  204 . That section is further connected to tubes  206  and  208 . An optical fiber inserted through the entry port  202  is advanced through tubes  204 ,  206  and  208  and will exit the distal end of tube  208  and enter, upon its advancement, into an entry port of the assembly  100  discussed above, then through the assembly to enter between rollers  114  and  116 . AS described above, rotation of the wheel or roller  102  will advance the fiber through tube  120  and finally into fiber lumen  39  as seen in  FIG. 5 . Due to the geartrain, very precise movements of the advancing optical fiber may be made. However, when the optical fiber is first “loaded” into the entry port  202 , to save time a more “gross” movement of the fiber through the handpiece and then through the fiber lumen may be desirable. This is achieved by the assembly  200  of  FIG. 9 . Assembly  200  includes an actuatable button  210  which is operatively connected to the lever train  212  and  214  such that lifting upward the button  210  results in the tube  208  moving in the distal direction towards the assembly  100 . Such distal movement causes tube  208  to enter between rollers  114  and  116 . Once this is accomplished, the rollers  114  and  116  will be in contact with the outer surface of the tube  208 . As a consequence, an optical fiber will be able to be “pushed” through the assembly  100  and the assembly  200  and through the fiber lumen  39  so that the operator may began the procedure. After such advancement, the operator may push the button down, which cause withdrawal in a proximal direction of the tube  208  so that the rollers  114  and  116  contact the optical fiber, thus assuring advancement by way of the wheel or roller  102 . 
         [0036]    Alternatively, one or both of the rollers  114  or  116  may be made to be constructed such that they is retractable away from the plane in which it engages the optical fiber during initial advancing of the fiber through the device. A potential issue with a handpiece which is orientated at an angle with respect to the aspiration/irrigation lumen and the fiber lumen is that, with respect to the aspiration/irrigation lumen, that stones and other material can get “hung up” within that lumen in the case of sharp turns within that lumen and, with respect to the fiber lumen, the fiber gets “hung up” on its advancement into the device due to sharp turns. As can be seen by reference to  FIGS. 5 through 9 , however, both the silicone tube  216  seen in  FIG. 9B  and the tube  120  seen in  FIG. 8B  are gently curved which minimizes if not eliminates the “hang up” problems. This allows for the handpiece to be orientated at a more convenient angle to the lumens for the operator&#39;s use. 
         [0037]    Turning now back to  FIG. 9 , the aspiration/irrigation lumen&#39;s proximal end  218 , as shown may be connected by well-known means to either a source (not shown) of vacuum to allow for evacuation and aspiration of materials and fluids within the body cavity or to a source (not shown) of irrigation to allow for irrigating the body cavity. It is possible during a procedure for a stone or other material object to become lodged within the aspiration/irrigation lumen or even at the distal end of such lumen. Further vacuum may not dislodge such stone or other material. In that event, the operator may switch from a vacuum operation to an irrigation operation to force the materials lodged in the lumen to be expelled for further treatment and fragmentation. 
         [0038]    In the operation and use of the apparatus disclosed in the present invention, a physician or other user inserts the combined optical fiber and aspiration/irrigation lumen through the urinary tract into the body cavity of the human, such as the bladder or the kidneys. After the device has been placed in the desired position, the physician or other operator inserts an optical fiber into the proximal end of the apparatus and pushes it through the metal tubes within the apparatus and through the optical fiber lumen using roller  102  until the optical fiber exits the optical fiber lumen and can be observed through a urethascope. The physician or other operator then advances the tip of the optical fiber to the stone or other materials sought to be fragmented and turns on the optical fiber activation device which may operate in high energy and long pulse mode (up to 6 joule/per pulse and up to 1700 ms per pulse) in order to reduce stone or other material repulsion and movement. Other potential parameters for the present invention include a range of about 0-6 joule/per pulse, a frequency of about 5-100 Hz, and a pulse width in the range of about 200 to about 1700 microseconds. Once a sufficient amount of material has been fragmented, the material may be withdrawn through the aspiration lumen by the physician or other operator by activating a vacuum source using switch  32 . The setback of the distal tip of the fiber lumen allows the physician or other operator to observe the condition of optical fiber tip and advance the tip further to continue fragmentation of stones or other materials. Stones or other materials lodged within the aspiration/irrigation lumen may be dislodged by reversing the operation to an irrigation mode to expel the lodged material or other debris.