Patent Document

RELATED APPLICATIONS  
       [0001]    This application claims the benefit of U.S. Provisional Application Ser. No. 60/226,901, filed Aug. 23, 2000, and incorporates that application herein, in its entirety, by reference. 
     
    
     
       FIELD OF THE INVENTION  
         [0002]    The present invention generally relates to method and apparatus for the performance of medical procedures at a target site remote from the medical practitioner performing the procedure. More particularly the present invention relates to method and apparatus for accurately deploying particular medical appliances from a medical device after the medical device has been positioned at a site targeted to receive the medical appliance.  
         BACKGROUND INFORMATION  
         [0003]    Medical procedures may be performed by a practitioner through direct contact and interface with a target site as well as through remote access to the target site via medical devices, such as endoscopes, which are designed to extend the practitioner&#39;s reach. By extending the practitioner&#39;s &#39;s reach these devices allow some medical procedures, previously performed only through invasive procedures, to be performed through non-invasive methodologies. One drawback of these extension devices and remote access methodologies is that a practitioner may not be able to watch the procedure being performed and, thus, may not be able to visually determine if the procedure he is performing has been properly completed.  
           [0004]    For instance, when an endoscope is being used for the ligation of a polyp deep within a patient&#39;s body, the distal end of the endoscope, where the procedure is actually carried out, is not directly visible to the practitioner. Nevertheless, despite this handicap, the practitioner must first maneuver the distal end of the endoscope to the targeted polyp and then, in less sophisticated systems, must perform the procedure relying solely on his or her own tactile abilities. In one endoscopic ligation unit this process would involve pulling on a single string emerging from the proximal end of the endoscope until one of the several bands, which the string was wrapped around at its distal end, was deployed. In this unit, if the string was pulled too far, more than one band may be deployed and, if the string was not pulled far enough, a band may not be deployed at all. During its use, once the practitioner thought that a single band was deployed, but without positive confirmation, the practitioner would relocate the distal end of the endoscope to deploy another band or if the procedure was completed, retract the endoscope from the patient.  
           [0005]    If the ligation bands had become entangled during the procedure they could remain on the distal end of the ligation unit and provide notice to the practitioner, upon the endoscope&#39;s removal, that the procedure was not properly performed. Conversely, if too many bands were deployed during the procedure or if they were deployed in the wrong areas, it would be difficult if not impossible for the practitioner to immediately discern, based on viewing the distal end of the ligation unit, that the bands had been improperly deployed from the endoscope.  
         SUMMARY OF THE INVENTION  
         [0006]    The present invention regards system, method, and apparatus for selectively and accurately deploying one or more sequentially positioned medical appliances from a portable medical device. An apparatus, in accord with one embodiment of the present invention, includes a ligation tip having an internal passage and an outside surface wherein the outside surface has a plurality of sequentially ordered deployable medical appliances in contact with it. The apparatus in this embodiment also includes a body having a channel in communication with the internal passage of the ligation tip, a string passing through the internal passage and the channel, and a means, coupled to the string, for affirmatively verifying that a specific medical appliance, from the plurality of sequentially ordered medical appliances, has been deployed from the ligation tip.  
           [0007]    A system for selectively deploying one or more sequentially positioned medical appliances from a portable medical device to a target site is provided in an alternative embodiment of the present invention. This system may include a flexible sheath having a channel, an inside surface, an outside surface, a distal end, and a proximal end. In addition, this sheath may contain a plurality of strings positioned within its channel wherein each string may have a first end and a second end, wherein the first end of at least one string may be coupled to a pull that has a unique marking, and wherein the second end of the string that is coupled to the unique marking may be in physical communication with a catch. The system in this embodiment may also include an external sealing plug positioned along the outside surface of the sheath between the sheath&#39;s distal end and proximal end, wherein the plug has a passage sized to slidably couple the sheath to it. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0008]    [0008]FIG. 1 is side perspective view of a removeable string system containing a plurality of strings prior to its insertion into a body in accord with one embodiment of the present invention.  
         [0009]    [0009]FIG. 2 is a side perspective view of the removeable string system containing a plurality of strings from FIG. 1 after it has been inserted into the body in accord with one embodiment of the present invention.  
         [0010]    [0010]FIG. 3 is a side perspective view of the removeable string system containing a plurality of strings from FIG. 1 after it has been inserted into the body and after the strings have been connected to the filaments of the ligation tip in accord with one embodiment of the present invention.  
         [0011]    [0011]FIG. 4 is a side perspective view of one of the strings, from the plurality of strings, being pulled in order to deploy a ligation band in accord with one embodiment of the present invention.  
         [0012]    [0012]FIG. 5 is a side perspective view of a medical apparatus in accord with one embodiment of the present invention.  
         [0013]    [0013]FIG. 6 is a side perspective view of the medical apparatus from FIG. 5 being used by a practitioner in accord with one embodiment of the present invention.  
         [0014]    [0014]FIG. 7 is a side perspective view of a medical apparatus in accord with one embodiment of the present invention. 
     
    
     DETAILED DESCRIPTION  
       [0015]    FIGS.  1 - 4  illustrate the components, assembly, and use of a medical device or apparatus that may be used to deploy ligation bands or other medical appliances within the body of a patient in accord with one embodiment of the present invention. The medical device depicted in these figures may be used independently or in conjunction with an endoscope or other device to perform endoscopic tubal ligations as well as numerous other procedures.  
         [0016]    [0016]FIG. 1 is a side perspective view of some of the components of the medical device that is depicted in FIGS.  1 - 4  (wherein like elements have been numbered throughout with like numerals). FIG. 1 illustrates the removable cable system  10  prior to its insertion into the y-extension extension  103  of tube or body  19  which may be an endoscope or any other device capable of creating an operating channel to a target site in the patient in accord with one embodiment of the present invention. As can be seen, this removable cable system  10  contains a plurality of filaments or strings  13  running through a flexible sheath  11 . The sheath  11 , which may be made from rubber, plastic or any other flexible and resilient material, may have a circular, hexagonal, octangular or other cross-sectional shape. However, regardless of which cross-sectional shape is used, it is preferable that the cross-sectional area be sized such that the sheath  11  may readily encase each of the strings  13  traveling through it, that the strings may not be bound within the sheath  11 , that the strings  13  may be readily pulled back and forth through the sheath  11  and that the sheath  11  containing the strings  13  may be sized to fit within the body  19  and the y-extension extension  103  of the body  19 .  
         [0017]    The system  10  of FIG. 1 may also include a sealing plug  18  having a bore  102  traveling through it wherein the bore  102  is sized to allow the sheath  11  to slide back and forth within it. This sealing plug  18  may be made from the same material as the sheath  11  or it may be made from a separate material. It may also be manufactured in conjunction with the sheath  11  or it may be placed around the sheath  11  after the sheath  11  has been manufactured. Moreover it may be added to the sheath either before and after the strings have been placed within the sheath  11 .  
         [0018]    The external sealing plug  18  may have a tang portion  101 , as illustrated in FIG. 1, that is sized to frictionally secure the sealing plug  18  to the y-extension  103  of the body  19 . When the tang portion  101  is inserted into the y-extension  103  the system  10  may continue to be able to slide in and out of the body  19  due to the size of the bore  102  in relation to the sheath  11 . In an alternative configuration, rather than using friction to secure the tang  101  to the y-extension  103  the tang portion  101  may contain threads that may be used to secure the sealing plug  18  to the body  19 . Moreover, in addition to this alternative configuration other securement configurations and methodologies, such as bendable clips and adhesives, may also be used to secure the sealing plug  18  to the y-extension  103  of the body  19 .  
         [0019]    The sheath  11  may also have a stopper  17  positioned on its outside surface. This stopper  17  may be made in conjunction with the sheath  1   1  or may be added at a later time. This stopper  17  is preferably fixedly secured to the sheath  11  and sized to prevent the sheath  11  from being completely slid through the bore  102  of the sealing plug  18 .  
         [0020]    The strings  13 , which are located within the sheath  11 , may have pulls  15  attached to one of their ends. These pulls  15  may have unique identifiers or tags  14  attached to them which act, with the pulls  15 , as a means for affirmatively verifying that the specific medical appliance from a plurality of medical appliances, has been deployed. Alternatively, rather than using a pull and tag system the pulls  15  may, themselves, be colored or otherwise identified to allow them to be effectively distinguished from one another.  
         [0021]    The opposite end of the strings  13 , (i.e. those not coupled to the pulls  15 ) may terminate in a loop or catch  16  or may at least be in physical communication with the loop or catch  16 . This catch  16  may be used, as shown in FIG. 3, to releasably connect the individual strings  13  of the system  10  to hooks  20  associated with individual ligating bands that surround the ligation tip  30  in FIG. 3 and may be deployed by pulling on the pulls  15  during a medical procedure.  
         [0022]    As can be seen in FIG. 2 the removeable cable system  10  may be inserted into the y-extension extension  103  of the body  19  until the tang  101  of the sealing plug  18  comes to rest within the end of the y-extension  103 . As can also be seen in this figure the sheath  11  and the strings  13  are sized such that when the sealing plug  18  comes to rest against the y-extension  103  of the body  19  the catches  16  extend past the distal end  22  of the body  19 . By sizing the sheath  11  and strings  13 , so that they are longer than this portion of the body  19 , the catches  16  may be readily attached to hooks  20  of the ligation tip  30  shown in FIG. 3.  
         [0023]    [0023]FIG. 3 illustrates a side view of the medical device from FIGS.  1 - 4  after the individual filaments  33  of the ligation tip  30  have been coupled to the strings  13  of the cable system  10 . As indicated by arrow  36 , once the requisite connections have been made between the filaments  33  and the strings  13 , the end  32  of the ligation tip  30  may be slid around or into the open end  22  of the body  19 . At the same time, to prevent the strings  13  and the filaments  33  from becoming entangled, the cable system  10  may be pulled, as indicated by arrow  34 , to remove any slack in the lines created by the insertion and coupling process. As can be seen, the stopper  17  may act to limit the distance that the cable system  10  may be pulled through the sealing plug  18 , and, thereby, prevent the premature deployment of all of the ligating bands from the tip  30  as would occur if the removable cable system  10  was pulled too far back up through the sealing plug  18 .  
         [0024]    The ligation tip  30 , which is fully evident in FIG. 4, may contain a plurality of ligation bands  31  that may be located around its outside surface. These ligation bands  31  may be individually coupled to the individual filaments  33  which are in turn individually coupled to the strings  13 . Thus, in use, as depicted in FIG. 4, by pulling on one of the pulls  15  as indicated by arrow  42  a specific ligation band  31  may be deployed from the ligation tip  30  as indicated by arrow  41 . Because each pull  15  has a unique marking to associate it with a specific deployable medical appliance, when an operator pulls a specifically marked pull, the operator will know which medical appliance, in this case a ligation band, is being deployed at that time. Thus, through this system, a practitioner may more accurately control the deployment of ligation bands from the distal end of a ligation unit as he can positively determine, from the proximal end of the device, which ligation band is being deployed  
         [0025]    [0025]FIG. 5 is a side perspective view of an alternative embodiment of the present invention. In FIG. 5 a means  50  for affirmatively verifying that at medical appliance from a plurality of medical appliances, has been deployed can be seen. This means  50  may be attached to an endoscope as illustrated in FIG. 6. This means  50  may contain a plunger  52 , a body  56 , a string  53 , and a variable length string passageway  51  and may be used to deploy ligation bands or other medical appliances located at the distal end of an endoscope. This means  50  accomplishes this task by shortening or otherwise pulling on a string contained within the passageway  51  that is coupled to a plurality of deployable medical appliances at the distal end of the endoscope. This string is pulled or shortened by a specific predetermined distance by depressing one of the plungers  52  of the means  50 . As the plunger  52  is depressed, the string  53  resident in the passageway  51  and coupled to anchoring point  57  will have its effective length shortened by the distance that it must now travel around the depressed plunger  52 . Thus, by depressing the plunger  52 , the string will be shortened and a ligation band or other device coupled to the string may be deployed by the medical device.  
         [0026]    A specific method of using the means  50  from FIG. 5 may include coupling the body  56  to an endoscope and then treading a string  53  through the string passageway  51  and anchoring point  57 . The distal end of the string  53  may then be threaded around each deployable medical appliance in sequential order. Then, as mentioned above, in order to deploy the medical appliance, the plunger  52  may be depressed, in order to draw the string  53  into the valley  58  associated with the plunger  53  thus altering the string&#39;s pathway and shortening its effective length. Consequently, when a plunger  52  is depressed, a medical appliance coupled to the string&#39;s distal end may be deployed from the distal end of the medical device. If a second medical appliance is to be deployed, a second plunger may be depressed while the first plunger is also depressed. Here, the effective length of the string will be twice shortened and the second medical appliance may be deployed. Likewise a third appliance may also be deployed by depressing the third plunger  52  while the first two are also depressed. The plungers in this embodiment may be depressed in any order to deploy the first, second, and the third medical appliances since the string is not bound underneath the depressed plungers but, is rather, able to slide back and forth underneath the depressed plunger.  
         [0027]    Advantages of this configuration include that the operator can readily detect the number of medical appliances that have been deployed and that, as can be seen in FIG. 6, the user may use a single hand to hold the endoscope and to deploy the medical appliances. In an alternative embodiment the plungers may be retained by some locking mechanism after the plunger has been depressed into the valleys  58  so that it is not necessary to hold down the plungers in order to deploy several bands. Conversely, the plungers may be biased in an open position to reduce the likelihood that the plunger will be errantly depressed by a practitioner during a procedure.  
         [0028]    An alternative embodiment of a means for affirmatively verifying that a specific medical appliance from a plurality of appliances has been deployed  70 , is illustrated in FIG. 7. This means  70  may be placed at the distal end of an endoscope and may be used to pull a string a predetermined distance in order to deploy a ligation band in communication with the string from a ligation tip at the distal end of the endoscope. This means  70  may include a shaft  76 , an opening  72 , and a slidable handle  71  coupled to the shaft  76  and adapted to be slid over the shaft  76 . The handle  71  may also contain several slots  78  that may be sized to secure a looped end  75  of a sting  701  that may be attached to a plurality of ligation bands at the distal end of the endoscope or other device. Consequently, as the handle  71  is incrementally advanced down the shaft  76  the string  701  may be pulled by that same incremental distance as the handle  71  is slid.  
         [0029]    Alternatively, in another embodiment, rather than having the string directly coupled to the ligating bands, a pulley system may be employed that adjusts or modifies the distance that handle needs to be pulled before each ligation band is deployed. This pulley system or mechanical advantage system may increase the distance that the handle needs to be pulled or conversely decrease the distance that the handle needs to be pulled.  
         [0030]    Also evident in FIG. 7 are a plurality of stops  73 ,  74 ,  77 , and  702  that protrude up from the shaft  76  and may be sized to arrest the travel of the handle  71  as it slides down the body  76 .  
         [0031]    These stops may be integrally formed with the shaft  76  and may be compressible or incompressible. The compressible stops  73 ,  77 , and  702  in this embodiment may be designed so that they may be depressed to allow the handle  71  to be slid over them and down the shaft from position to position as indicated by arrows  702  in FIG. 7. Conversely, stop  74 , which is fixed and incompressible in this embodiment, may act to prevent the handle  71  from sliding further down the body  76 , thus acting as a block at the end of the handle  71 . In addition, stops may also be used to arrest the travel of the handle  71  in the direction opposite to the arrows  702 . An example of this type of stop is stop  79  which is shown preventing the handle  71  from sliding closer to opening  703  and obstructing the string  701  that protrudes from it. In this embodiment, as well as the embodiments discussed above, the shaft or body of the device may be made from rigid plastic, surgical grade metals, and other suitable materials.  
         [0032]    Method and apparatus for deploying medical appliances from a medical appliance is provided. While several embodiments of the present invention have been described above other embodiments within the spirit and scope of the present invention are also plausible.

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