Abstract:
A treatment device for endoscopic therapy of the present invention includes a suturing-ligating member having a distal end portion and a proximal end portion, that carries out at least one of suturing and ligation of biological tissue, a stopper provided to be movable forward or backward on an proximal end side of the suturing or ligating member, and stoppable by friction on the suturing-ligating member to maintain the biological tissue in a sutured or ligated state by the suturing-ligating member, and a suturing-ligation releasing member provided movable with relative to the suturing-ligating member to release the suturing-ligation state maintained by firctional stopping between the suturing-ligating member and the stopper by moving the releasing member to the proximal end portion side of the suturing-ligating member.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]     This application claims the benefit of U.S. Provisional Application No. 60/572,987, filed May 20, 2004. 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]     1. Field of the Invention  
         [0003]     The present invention relates to a treatment device for biological tissue for endoscopic treatment, and more particularly, to a treatment device for suturing or ligating an internal biological tissue in combination with an endoscope.  
         [0004]     2. Description of the Related Art  
         [0005]     A device that sutures or ligates an internal tissue under endoscopic observation is disclosed in U.S. patent Application Publication No. 2003/0236535A1. The device disclosed in this U.S. patent application publication can suture or ligate the tissue by penetrating a ligature having a fixing member through the tissue.  
         [0006]     In case where a desired region cannot be sutured or ligated by means of a device such as the one represented in this U.S. patent application publication, the ligature must be cut to cancel a sutured or ligated state. The ligature can be thus cut by endoscopically using, for example, a scissor forceps or the like. If the ligature is buried in the tissue, however, forceps operation for cutting the ligature without injuring the tissue is very troublesome.  
         [0007]     On the other hand, the fixing member for fixing a suture or ligature to the biological tissue may be removed by being endoscopically grasped with a grasping forceps or the like. If the fixing member has a shape such that it cannot be grasped easily, in this case, however, the forceps operation is very troublesome.  
       BRIEF SUMMARY OF THE INVENTION  
       [0008]     An object of the present invention is to provide a device and a method for easily releasing suturing or ligation carried out in biological tissue by means of an endoscopic treatment.  
         [0009]     According to an aspect of the present invention, there is provided a treatment device for biological tissue, capable of suturing or ligating a biological tissue under endoscopic observation and of releasing the tissue from a sutured or ligated state by simple operation.  
         [0010]     According to another aspect of the present invention, there is provided a treatment device for endoscopic therapy, comprising: 
        a. suturing-ligating member having a distal end portion and a proximal end portion, that carries out at least one of suturing and ligation of biological tissue;     a stopper provided to be movable forward or backward on an proximal end side of the suturing or ligating member, and stoppable by friction on the suturing or ligating member to maintain the biological tissue in a sutured or ligated state by the suturing or ligating member; and     a suturing-ligation releasing member provided movable with relative to the suturing or ligating member to release the suturing or ligation state maintained by firctional stopping between the suturing or ligating member and the fixing member by moving the releasing member to the proximal end portion side of the suturing or ligating member.        
 
         [0014]     Advantages of the invention will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Advantages of the invention may be realized and obtained by means of the instrumentalities and combinations particularly pointed out hereinafter. 
     
    
     BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING  
       [0015]     The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate embodiments of the invention, and together with the general description given above and the detailed description of the embodiments given below, serve to explain the principles of the invention.  
         [0016]      FIG. 1  is a schematic general view of a treatment device according to a first embodiment of the present invention;  
         [0017]      FIG. 2  is a schematic view showing a state in which a biological tissue is ligated with use of the treatment device of  FIG. 1 ;  
         [0018]      FIG. 3  is a schematic view showing a state in which the ligation of the biological tissue is completed;  
         [0019]      FIG. 4  is a schematic view showing the way the biological tissue is released from the ligated state;  
         [0020]      FIG. 5  is a schematic view showing completion of the release of the biological tissue from the ligated state;  
         [0021]      FIG. 6  is a schematic general view of a treatment device according to a second embodiment;  
         [0022]      FIG. 7  is a schematic view showing a state in which a biological tissue is ligated with use of the treatment device according to the second embodiment;  
         [0023]      FIG. 8  is an explanatory view showing a state in which a puncture needle is passed through the biological tissue;  
         [0024]      FIG. 9  is an explanatory view showing a state in which a cylindrical member attached to a ligature is pushed out of the distal end of the puncture needle;  
         [0025]      FIG. 10  is an explanatory view showing a state after the puncture needle is drawn out of the biological tissue;  
         [0026]      FIG. 11  is an explanatory view showing a state after completion of ligation of the biological tissue;  
         [0027]      FIG. 12  is a schematic general view of a treatment device according to a first modification;  
         [0028]      FIG. 13  is a schematic general view of a treatment device according to a third embodiment;  
         [0029]      FIG. 14  is a schematic view showing a state after a biological tissue is sutured with use of the treatment device according to the third embodiment;  
         [0030]      FIG. 15  is an explanatory view showing the way the sutured state is canceled;  
         [0031]      FIG. 16  is a schematic general view of a treatment device according to a second modification;  
         [0032]      FIG. 17  is an enlarged view of a part of  FIG. 16 ;  
         [0033]      FIG. 18  is a schematic general view of a treatment device according to a fourth embodiment;  
         [0034]      FIG. 19  is a schematic general view of a treatment device according to a third modification;  
         [0035]      FIG. 20  is a schematic general view of a treatment device according to a fifth embodiment; and  
         [0036]      FIG. 21  is an enlarged view of a part of  FIG. 20 . 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
     First Embodiment  
       [0037]     FIGS.  1  to  5  show a medical treatment device according to a preferred first embodiment of the present invention.  
         [0038]     (Configuration)  
         [0039]     As shown in  FIG. 1 , the medical treatment device according to the present embodiment is formed as a device for ligating biological tissue. The treatment device  1  can be used to ligate, e.g., a polyp before respecting it, thereby restraining bleeding effectively. The treatment device  1  comprises a loop-shaped ligature  10 , a silicone tube  11  through which the ligature  10  is passed, and a flexible wire  20  connected to the silicone tube  11  and having an enlarged portion  21  on its distal end.  
         [0040]     The ligature  10  is provided with a loop-shaped or ring-shaped operating section  50  on its proximal end portion. Although the flexible wire  20  shown in  FIG. 1  is only one in number, two or more flexible wires may be used in place of it. Since too many flexible wires may possibly exert adverse effects, such as entangling the treatment device  1  indwelt in a human body, one or two flexible wires  20  should preferably be used. Further, the flexible wire  20  may be formed having a belt-shaped structure in place of the elongate linear structure as illustrated.  
         [0041]     (Function)  
         [0042]     FIGS.  2  to  5  illustrate functions of the treatment device  1  described above.  
         [0043]     As shown in  FIG. 2 , the treatment device  1  is used in combination with a ligator  33 , which is composed of a ligation sheath  30 , a hook wire  32 , and an operating handle (not shown) for operating the hook wire  32 . The hook wire  32  has on its distal end a hook  31  that engages the operating section  50  of the ligature  10 .  
         [0044]     In ligation, the loop-shaped ligature  10  is hitched to a target tissue  60 , and the hook  31  is pulled to contract the loop of the ligature  10 . Thereafter, the silicone tube  11 , which serves as a stopper is pushed toward the target tissue  60  with the distal end portion of the ligation sheath  30 , and moved along the ligature  10  in the direction further to contract the loop of the ligature  10 , whereby the target tissue  60  is ligated with the silicone tube  11  being stopped by friction on the ligature  10 .  FIG. 3  shows a state in which the target tissue  60  is ligated and proximal-end-side odds of the ligature  10  that project from the silicone tube  11  are cut.  
         [0045]     Preferably, a scope  40  having a channel through which a grasping forceps  41  can be passed, as shown in  FIGS. 3 and 4 , should be used in canceling the ligated state. The flexible wire  20  is grasped by the grasping forceps  41  that is inserted into the human body through the scope  40 , and pulled with a force greater than the frictional fixing force of the silicone tube  11 . Thereupon, the silicone tube  11  is moved to the proximal end side of the ligature  10  and disengaged from the ligature  10 .  FIG. 5  shows a state in which the ligation is canceled.  
         [0046]     The flexible wire  20  can be grasped more easily through an endoscope than when the silicone tube  11  is grasped directly. Thus, the silicone tube  11  can be easily moved to the proximal end side from any direction without adversely influencing the tissue during manipulation. The enlarged portion  21  on the distal end of the flexible wire  20  can prevent the grasping forceps  41  from failing to grasp the tissue. The flexible wire  20 , which serves as a suturing-ligature releasing member, may be formed of any material that is flexible and strong enough to stand a pull when ligation is canceled. Preferably, it should be made of a stretched polyamide-based synthetic fiber, a material for a conventional suture, such as polypropylene, polyethylene terephthalate, or polytetrafluoroethylene, or a bioabsorbable material, such as polyglycol acid, for example. Further, the flexible wire  20  may be either a monofilament or a twisted yarn. In view of visibility, moreover, white, red, and yellow that resemble the colors of biological tissues are not preferred as the color of the flexible wire  20 . Furthermore, the color of the wire should be different from that of the ligature  10 .  
       Second Embodiment  
       [0047]     FIGS.  6  to  11  show a treatment device  2  according to a second embodiment of the present invention. The following various embodiments or modifications are basically the same as the foregoing embodiment, so that like numerals refer to like regions of the foregoing embodiment, and a detailed description of those regions is omitted.  
         [0048]     (Configuration)  
         [0049]     The second embodiment differs from the first embodiment in that the treatment device  2  according to the present embodiment is provided with a cylindrical member  12  on its distal end portion without the formation of a loop-shaped form in a ligature  10 , as shown in  FIG. 6 .  
         [0050]     (Function)  
         [0051]     FIGS.  7  to  10  illustrate functions of the treatment device  2  according to the second embodiment.  
         [0052]     As shown in  FIG. 7 , the treatment device  2  is used in combination with a ligator  33 , which resembles the one according to the first embodiment, and a hollow puncture needle  34 , which has a push wire  35  inside and can store the cylindrical member  12 .  
         [0053]     First, the puncture needle  34  through which the cylindrical member  12  is passed is inserted through the target tissue  60 , as shown in  FIG. 8 . Thereafter, the push wire  35  is advanced toward the distal end of the puncture needle  34 , whereby the cylindrical member  12  is discharged out of the puncture needle  34 , as shown in  FIG. 9 . Thereafter, the puncture needle  33  is drawn out of the tissue  60 , as shown in  FIG. 10 , whereupon the target tissue  60  can be ligated in the same manner as in the first embodiment by pulling the hook  31 .  
         [0054]      FIG. 11  shows a state the target tissue  60  is ligated by means of the treatment device  2 . In releasing the target tissue  60  from the ligation, a flexible wire  20  is pulled with a grasping forceps or the like, as in the first embodiment. Thus, a silicone tube  11  is moved to the proximal end side of the ligature  10  and disengaged from it, whereupon the ligated state can be canceled.  
         [0055]     Besides the effects of the first embodiment, according to the present embodiment, the cylindrical member  12  that fixes the target tissue  60 , along with the ligature  10 , penetrates the target tissue  60 , so that the ligature  10  can be prevented from coming off the tissue during the ligation.  
         [0056]     [First Modification] 
         [0057]      FIG. 12  shows a modification of the second embodiment.  
         [0058]     (Configuration)  
         [0059]     The modification differs from the second embodiment in that a treatment device  3  according to the present embodiment has a loop-shaped flexible wire  20 , which is passed through a hole that is bored in a silicone tube  11  in the direction perpendicular to its lumen axis, as shown in  FIG. 12 .  
         [0060]     (Function)  
         [0061]     According to this treatment device  3 , which also enjoys the same functions and effects of the second embodiment, the flexible wire  20  is loop-shaped so that it can be easily grasped to ensure pulling force greater than in the case of a single wire.  
       Third Embodiment  
       [0062]     FIGS.  13  to  15  show a third embodiment of the present invention.  
         [0063]     (Configuration.)  
         [0064]     The third embodiment differs from the second embodiment in that a treatment device  4  according to the present embodiment is formed to be used to suture the target tissue  60 , as shown in  FIG. 13 . For example, it can be practically used to suture and close perforations such as ulcers in the target tissue  60 , for example.  
         [0065]     This treatment device  4  is designed so that two ligatures  10  having a cylindrical member  12  each are passed through a silicone tube  11 . The respective proximal end portions of the two ligatures  10  are connected to each other, and a ring- or loop-shaped operating section  50  is provided on the proximal end. Each ligature  10  is provided with a distal-side pledget  13 , which is located in a position between each cylindrical member  12  and the silicone tube  11  and near the cylindrical member  12  and has a central hole through which the ligature  10  is passed. Further, a hand-side pledget  14  is located in a position between the cylindrical members  12  and the silicone tube  11  and near the silicone tube  11 . It has a central hole through which the ligature  10  is passed.  
         [0066]     The silicone tube  11  is provided integrally with four outwardly projecting blade-shaped grip members  22  in place of a flexible wire  20 . Further, the silicone tube  11  is provided integrally with a magnet  23 .  
         [0067]     The two ligatures  10  are passed through a tearing-preventive tube  15  in a position near the silicone tube  11 . The tearing-preventive tube  15  is provided with the flexible wire  20  that has an enlarged portion  21 .  
         [0068]     (Function)  
         [0069]     The same functions and effects of the second embodiment can be obtained according to this treatment device  4 . Since the treatment device  4  is provided with the distal-side pledgets  13  and the hand-side pledget  14 , moreover, the cylindrical members  12  and the silicone tube  11  can be prevented from being buried in the target tissue  60  even after the suturing.  
         [0070]     If the silicone tube  11  is situated in a position such that it cannot be easily seized with a grasping forceps, as shown in  FIG. 14 , the silicone tube  11  can be moved to a position for easy grasping by magnetically attracting the magnet  23 , which is attached to the silicone tube  11 , with use of a magnet forceps  42  that is passed through the channel of the scope  40 , as shown in  FIG. 15 . Since the silicone tube  11  is provided with the grip members  22 , moreover, slipping of the grasping forceps  41  can be prevented when the silicone tube  11  is seized with the grasping forceps  41 . Thus, the silicone tube  11  can be securely grasped with a greater force as it is moved and disengaged.  
         [0071]     Since the grip members  22  are provided integrally on the silicone tube  11 , they can be prevented from coming off the silicone tube  11  when they are trailed. Further, the tearing-preventive tube  15  can restrain the two ligatures  10  from being spread to expand the bore of the silicone tube  11  by the repulsive force of the target tissue  60  during the suturing process, thereby preventing the silicone tube  11  from being damaged. By grasping the flexible wire  20  attached to the tearing-preventive tube  15  with the grasping forceps  41  or the like and pulling it, the tearing-preventive tube  15  can be trailed to move and disengage the silicone tube  11  so that the sutured state is canceled.  
         [0072]     The pledgets  13  and the hand-side pledget  14  may be formed of any material that is flexible and strong enough to stand the repulsive force of the tissue and pressures from the ligatures  10  and the cylindrical members. Preferably, they should be made of PTFE or silicone resin, for example. Further, they can enjoy higher visibility if their colors are different from those colors, such as red, yellow, etc., which resemble the colors of organic tissues.  
         [0073]     [Second Modification] 
         [0074]     A second modification shown in  FIGS. 16 and 17  is a modification of the third embodiment.  
         [0075]     (Configuration)  
         [0076]     As shown in  FIG. 16 , a treatment device  5  according to the second modification differs from the third embodiment in the following particulars.  
         [0077]     First, a silicone tube  11  is provided with neither grip members  22  nor a magnet  23 . Secondly, a loop-shaped flexible wire  20 , in place of the tearing-preventive tube, is slidably wound around a ligature, as shown in  FIG. 17 . In this modification, as shown in  FIG. 17 , the flexible wire  20  is wound in a manner such that one ring portion is passed through the other ring portion.  
         [0078]     (Function)  
         [0079]     According to this treatment device  5 , which enjoys the same functions and effects of the third embodiment, further functions and effects can be obtained such that the number of components used therein can be reduced to ensure high productivity, and that the loop-shaped flexible wire  20  can be easily grasped to ensure pulling force greater than in the case of a single wire.  
       Fourth Embodiment  
       [0080]      FIG. 18  shows a fourth embodiment of the present invention.  
         [0081]     (Configuration)  
         [0082]     A treatment device  6  according to the fourth embodiment differs from the first embodiment in the following particulars.  
         [0083]     As shown in  FIG. 18 , the treatment device  6  according to the present embodiment is provided with a hand-side pledget  14  having a central hole through which a ligature  10  is passed. The pledget  14  is situated near the distal end side of a silicone tube  11  on the ligature  10 . A loop-shaped flexible wire  20  is passed through two holes  16  that are arranged symmetrically with respect to the hole of the hand-side pledget  14  through which the ligature  10  is passed. The flexible wire  20  is slidably passed through the two holes  16  in the hand-side pledget.  
         [0084]     (Function)  
         [0085]     This treatment device  6  can provide the following functions and effects, besides the same functions and effects of the first embodiment.  
         [0086]     Since the flexible wire  20  is attached to the hand-side pledget  14 , the flexible wire  20  can be prevented from being buried in the tissue. The loop-shaped flexible wire  20  is slidable with respect to the hand-side pledget  14 . If any part on the flexible wire  20  is grasped as it is pulled, therefore, the flexible wire  20  slides on the hand-side pledget  14  so that it extends in a straight line from its junction with the hand-side pledget  14  to a grip position. Thus, the silicone tube  11  can be easily trailed without dispersion of the pull force.  
         [0087]     [Third Modification] 
         [0088]     A third modification shown in  FIG. 19  is a modification of the fourth embodiment.  
         [0089]     (Configuration)  
         [0090]     In a treatment device  7  according to the present modification, as shown in  FIG. 19 , unlike the fourth embodiment, a flexible wire  20  having an enlarged portion  21  on its distal end is connected to a hand-side pledget  14 .  
         [0091]     (Function)  
         [0092]     According to this treatment device  7 , compared with the fourth embodiment, the flexible wire  20  is shaped so that it is not space-consuming when the treatment device  7  is indwelt in the human body. Thus, food or the like or the scope  40  or grasping forceps  41  can be prevented from catching the flexible wire  20  during release operation.  
       Fifth Embodiment  
       [0093]      FIGS. 20 and 21  show a fifth embodiment of the present invention.  
         [0094]     (Configuration)  
         [0095]     A treatment device  8  according to the fifth embodiment differs from the treatment device  7  according to the fourth embodiment in the following particulars.  
         [0096]     Two ligatures  10  having a cylindrical member  12  each are passed through a silicone tube  11 . A distal-side pledget  13  is located in a position between the cylindrical member  12  on each ligature  10  and the silicone tube  11  and near the cylindrical member  12 . The ligature  10  is passed through a hole in its central portion. As shown in  FIG. 21 , a loop-shaped flexible wire  20  that is attached to a hand-side pledget  14  passes between the two ligatures  10  as it passes from one of two holes  16  in the hand-side pledget  14  to the other.  
         [0097]     (Function)  
         [0098]     According to this treatment device  8 , which also enjoys the same functions and effects of the fourth embodiment, the distal-side pledgets  13  prevent the cylindrical members  12  from being buried in the target tissue  60 . Since the loop-shaped flexible wire  20  passes between the two ligatures  10 , the lumen axis of the silicone tube  11  is always coaxial with the direction in which the flexible wire  20  is pulsed. Thus, resistance between the silicone tube  11  and the ligatures  10  is minimized, so that the silicone tube  11  can be trailed with a smaller force.  
         [0099]     Additional advantages and modifications will readily occur to those skilled in the art. Therefore, the invention in its broader aspects is not limited to the specific details and representative embodiments shown and described herein. Accordingly, various modifications may be made without departing from the spirit of the general inventive concept.