Abstract:
A tissue-piercing device includes two piercing members, and an operation section to which a proximal end of each of the piercing members is connected. Each of the piercing members includes a flexible outer sheath, a slidable inner sheath which is slidably inserted in the outer sheath, and a slidable needle which is inserted in the inner sheath. A switch portion is provided for switching between an operation mode in which a piercing action by the two piercing members is performed in a single operation, and an operation mode in which piercing actions by the two piercing members are performed in respective separate operations. The switch portion includes a sheath-coupling member to couple and decouple the two slidable inner sheaths. The switch portion may include a needle-coupling member to couple and decouple the two slidable needles.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
   This application claims the benefit of U.S. Provisional Application to Koichi Kawashima et al, entitled “Endoscopic Instruments,” application No. 60/281,015, filed Apr. 4, 2001. 

   BACKGROUND OF THE INVENTION 
   1. Field of the Invention 
   The present invention relates to suture instruments that are used for endoscopically suturing tissue in the living body, especially to those suture instruments used in conjunction with flexible endoscopes. 
   2. Description of the Related Art 
   Currently, in many cases, in-vivo tissue of a patient is sutured through surgical operation. A surgical operation, however, is highly invasive because it naturally requires an incision to the patient body. Furthermore, it requires post-operative hospitalization, the cost of which can be a heavy burden for the patient. In these circumstances, the development of a low-invasive oral endoscopic procedure that eliminates the need for open surgery is anticipated. 
   For example, there is an instrument for suturing in-vivo tissue through an oral endoscopic, the arrangement of which has been disclosed in the U.S. Pat. No. 5,792,153. (See FIG. 22 through FIG. 26) 
   The instrument (a) which can be mounted on an endoscope, comprises a tube (b) that can be connected to the suction source, a cavity (c) to which the tube (b) is joined, a hollow needle (d) inserted in the forceps channel of the endoscope, a tag (g) provided with a lumen and side holes (e and f) that can be incorporated into the needle, a wire (i) with a valve (h) which can move back and forth in the needle (d) and can be mounted to the side hole (e) detachably, a thread (j) tied to the tag (g), and a grasping member (k) which is provided at the tip of the cavity (c) and is easily connected and disconnected to the side hole (f). 
   With the valve (h) joined to the side hole (e), the tag (g) is inserted into the needle (d). Then, an endoscope, with the instrument (a) mounted on it, is orally inserted into the patient lumen to suck the tissue (l) to be sutured into the cavity (c). The tissue (l) is then penetrated with the needle (d) that has been thrust out through the endoscope tip. Next, the wire (i) is pushed forward to thrust out the tag (g) through the needle (d) so that the side hole (f) of the tag (g) can be joined to the grasping member (k). The valve (h) is then removed from the side hole (e) so as to pull the wire (i) and the needle (d) into the endoscope. After this, suction is released. 
   Again, the tissue (l) is sucked into the cavity (c) to be penetrated with the needle (d). Then the valve (h) is joined to the side hole (e) and the grasping member (k) is removed from the opening (f). The valve (h), the tag (g) and the needle (d) are withdrawn and the suction is released. The steps above are repeated as many times as are necessary and then the instrument (a) is removed from the lumen together with the endoscope. When both ends of the thread, which have been pulled out from the body, are tied together and fixed, the suture procedure is terminated. 
   However, in the arrangement disclosed in U.S. Pat. No. 5,792,153, fine control of location of the penetration is very difficult because penetration is performed with the tissue placed inside the cavity. This will prevent the tissue from being securely sutured, or will require more stitches than necessary, resulting in extended operation time. 
   Moreover, inability to control the intervals between the stitches will prevent the tissue from being securely sutured with less number of stitches. 
   In addition, each penetration requires joining the valve (h) and the side hole (e) and releasing the grasping member (k) and the opening (f) and vice versa. These two operations, required per penetration, will make the treatment procedure very complicated, extending the treatment time as well. 
   Application of the procedure will be limited because the size of the cavity determines the area to penetrate at one time, making suture impossible when the suture area is too large to suck in the cavity. If the length or the height of the cavity is increased to hold more tissue to be sutured, there will inevitably be an increase in length and diameter of the instrument (a) itself, making it impossible to insert it into the body lumen or to locate the penetration for accurate suture. These can not only impose more burdens onto the patient at the time of its insertion but also possibly extend the treatment time. 
   The instrument (a) requires inserting the tag (g) into the needle (d) from the tip of the needle. This can accidentally cause the operator to prick his finger with the needle while he is trying to insert the tag into it. 
   SUMMARY OF THE INVENTION 
   The first objective of the present invention is to provide a suture instrument that can accurately suture in-vivo tissue. 
   The second objective of the present invention is to provide a suture instrument that enables easy access to the suture area and delicate control of the location of the penetration needle. 
   The third objective of the present invention is to provide a suture instrument that enables easy operation and ensures a short treatment time. 
   The fourth objective of the present invention is to provide a suture instrument imposing no limitation to the suture area of the in-vivo tissue. 
   The fifth objective of the present invention is to provide a suture instrument that enables easy insertion into the body lumen with minimum harm to the patient. 
   The sixth objective of the present invention is to provide a suture instrument that ensures a higher level of safety for both operator and patient. 
   In accordance with the present invention, a tissue-piercing device to be used with an endoscope has two piercing members and each piercing member has a needle. The two needles may be parallel and apart from each other. 
   In addition, the two needles may be hollow. 
   The tissue-piercing device may also include operation sections at the proximal ends of the piercing members; a distal coupling member for connecting distal ends of the piercing members; and a proximal coupling member for connecting the operation sections of the piercing members. 
   The distal coupling member may be formed to be mounted to the distal end of the endoscope, and the proximal coupling member may be formed to be mounted to the operation section of the endoscope. Furthermore, the distal coupling member may be a cap and the cap may be made of transparent material. 
   Each piercing member may include a flexible outer sheath, a slidable flexible inner sheath which is inserted in the outer sheath and is extended from or retracted into the distal end of the outer sheath, a slidable needle which is inserted in the inner sheath and is extended from or retracted into the distal end of the inner sheath, a housing to be connected to the proximal end of the outer sheath, an inner sheath operation means connected to the proximal end of the inner sheath for moving back and forth the inner sheath, and a needle operation means connected to the proximal end of the needle for moving back and forth the needle. 
   The tissue-piercing device may also include a switch means for switching between a two-piercing member operation and a separate operation. It may also include a switch means for switching between a two-needle/inner sheath operation and a separate operation. When the switch means selects a two-needle operation, the needle extension may be varied to allow piercing the tissue with one needle after another 
   The endoscope may be a flexible endoscope. The tissue-piercing device may be used to suture tissue in the human body. 

   
       FIG. 1  shows a piercing device according to a first embodiment of the present invention; 
       FIG. 2  shows a main body of the piercing device according to the first embodiment; 
       FIG. 3  shows an inner sheath according to the present invention; 
       FIG. 4  shows a first needle according to the present invention; 
       FIG. 5  shows a second needle according to the present invention; 
       FIG. 6  is a cross-sectional view of a proximal end of a grip of the operation section of the piercing device according to the first embodiment; 
       FIG. 7  is a cross-sectional view of the first needle inserted into the inner sheath; 
       FIG. 8  is a cross sectional view of the needle grip of the first needle; 
       FIG. 9  shows a needles-coupling member according to the first embodiment; 
       FIG. 10  shows the piercing device according to the first embodiment mounted to an endoscope; 
       FIG. 11  shows grasping tissue using a second endoscope; 
       FIGS. 12 and 13  show piercing the tissue using the piercing device of the first embodiment; 
       FIGS. 14-16  show the insertion of a suture into the tissue using the tissue-piercing member of the first embodiment; 
       FIGS. 17 and 18  show fixing the suture; 
       FIG. 19  shows a needles-coupling member according to a second embodiment of the present invention; 
       FIG. 20  shows a piercing device according to the second embodiment; 
       FIG. 21  shows piercing tissue using the piercing device according to the second embodiment; and 
       FIGS. 22-26  show a suturing instrument according to U.S. Pat. No. 5,792,153. 
   

   DESCRIPTION OF THE PREFERRED EMBODIMENTS 
   First Embodiment (FIGS.  1  to  18 ) 
   Description of a Piercing Device and a Knot Pusher ( FIGS. 1 to 9 ) 
   A piercing device  1  comprises a main body  2 , inner sheaths  3   a  and  3   b , needles  4  and  13 , an inner sheaths-coupling member  5 , and a needles-coupling member  6 . 
   The main body  2  comprises two outer sheaths  7   a  and  7   b , caps  8  connected at the distal ends of the sheaths  7   a  and  7   b , and an operation section  9  connected at the proximal end of the sheaths  7   a  and  7   b . The cap  8  comprises an outer sheaths-connecting section  10 , a distal cylindrical section  11 , and a distal mounting section  12 . The distal cylindrical section  11  is made of a relatively hard material. Preferably, it is made of a transparent plastic material such as polycarbonate lest it should obstruct the vision of a first endoscope  27 . Preferably, the inner diameter is about 5 to 15 mm, the wall thickness is about 1 mm. The length is about 3 to 10 mm, and a shorter cylinder is better. 
   The distal mounting section  12  is cylindrical and is inserted detachably to the distal end of the first endoscope  27 . The first endoscope is flexible endoscope. The distal mounting section  12  is made of a relatively soft plastic material such as PVC or other thermoplastic elastomer. Its inner diameter depends on the size of the distal end of the endoscope to be used and is generally about 10 mm. The outer sheaths-connecting section  10  has a ring section fixed over the periphery of the distal cylindrical section  11 , and connection legs  14   a  and  14   b  which are extending longitudinally and axially, parallel with each other. The connection legs  14   a  and  14   b  are preferably positioned at opposite sides and 180 degrees apart from one another. The connection legs  14   a  and  14   b  are preferably apart by 10 to 20 mm, depending on the outer diameter of the distal cylindrical section  11 . The connection legs  14   a  and  14   b  have penetration holes and form openings  15   a  and  15   b  at the distal end. 
   The outer sheaths  7   a  and  7   b  are hollow and flexible enough to follow the curvature of the first endoscope  27 . 
   For example, they are plastic tubes made of fluoroplastics, polyethylene, polyamide, polyimide, polyurethane or other thermoplastic elastomer, or metal coils. They may be metal coils covered by plastic tubes. They may be plastic tubes with metal mesh to prevent kink. The inner diameter is about 1 to 2 mm, the outer diameter is about 1.5 to 3 mm, and the length is about 1 to 1.5 m. The distal ends of the outer sheaths  7   a  and  7   b  are fixed to the connection legs  14   a  and  14   b  and are in parallel positions. The openings  15   a  and  15   b  are connected and communicated with the lumen of the outer sheaths  7   a  and  7   b.    
   The operation section  9  comprises a base  16 , grips  17   a  and  17   b , sliders (inner sheath operation means)  18   a  and  18   b , a proximal mounting section  20 , and a channel port  21 . The proximal ends of the outer sheaths  7   a  and  7   b  penetrate the base  16  and are connected to the distal ends of the grips  17   a  and  17   b.    
   The grips  17   a  and  17   b  are cylindrical, and have screws  24   a  and  24   b  on the periphery of the proximal ends with which slider locks  22   a  and  22   b  are engaged. Between the screws  24   a  and  24   b  and the slider locks  22   a  and  22   b , there are elastic tubular fixing rings  23   a  and  23   b  made of rubber such as silicon rubber or fluorine rubber, or thermoplastic elastomer. Sliders  18   a  and  18   b  are positioned slidably inside the fixing rings  23   a  and  23   b . When the slider locks  22   a  and  22   b  are tightened, the fixing rings  23   a  and  23   b  are pressed longitudinally and expanded radially to immobilize the sliders  18   a  and  18   b.    
   The sliders  18   a  and  18   b  are cylindrical. They are comprised of slider stoppers  25   a  and  25   b  at the proximal end for limiting a sliding area against the grips  17   a  and  17   b , slider port  19   a  and  19   b , and narrow sections  26   a  and  26   b  for connecting the inner sheaths-coupling member  5 . The proximal mounting section  20  is mounted at the distal end of the base  16 , and is fixed detachably to a forceps channel port  28  of the first endoscope  27 . 
   The channel port  21  is mounted to the proximal end of the base  16 , and is plugged detachably with a forceps valve  29 . The channel port  21  is connected through the lumen of the proximal mounting section  20  and the lumen in the base  16  to the forceps channel (not shown) of the first endoscope  27 . 
   The inner sheath  3   a  or  3   b  comprises an inner sheath port  30 , an inner sheath pipe  31 , an O ring  32 , and a sheath section  33 . The inner sheath  3   a  or  3   b  can be inserted via the slider port  19  into the outer sheath  7 . 
   When the inner sheath  3  is inserted to the outer sheath  7 , the inner sheath port  30  is connected detachably to the slider port  19 . The inner sheath port  30  has a lumen. 
   The inner sheath pipe  31  is connected to the sheath section  33  and the inner sheath port  30 . The lumen of the inner sheath pipe  31  is also communicated with the lumen of the sheath section  33  and the lumen of the inner sheath port  30 . 
   The O ring  32  is held between the proximal end of the inner sheath pipe  31  and the inner sheath port  30 . It is made of elastic rubber such as silicon rubber or fluororubber, or thermoplastic elastomer. It is received in grooves  51   a  and  51   b  of needle bodies  34   a  and  34   b  of the needles  4  and  13 , which is described later, and stops movement of the needle bodies  34   a  and  34   b.    
   The sheath section  33  is hollow and flexible enough to follow the curvature of the first endoscope  27 . For example, it is a plastic tube made of fluoroplastics, polyethylene, polyamide, polyimide, polyurethane or other thermoplastic elastomer, or a metal coil. It may be a plastic tube with metal mesh to prevent kink. The inner diameter is about 0.5 to 1.5 mm, and the outer diameter is about 1 to 2.5 mm. 
   When the slider  18  slides against the grip  17 , The sheath section  33  slides in the outer sheath  7 . The length of the inner sheath  3  is adjusted so that the distal end of the sheath section  33  is positioned proximal to the opening  15  when the slider  18  is pulled completely from the grip  17 , and the distal end of the sheath section  33  is positioned distally about 15 to 50 mm from the opening  15  of the cap  8  when the slider  18  is pushed sufficiently to touch the grip  17 . 
   The needle  4  comprises the needle body  34   a , a needle grip (needle operation means)  35  connected to the proximal end of the needle body  34   a , and suture-holding forceps  38  inserted in them. 
   The needle  13  comprises the needle body  34   b , a needle grip (needle operation means)  46  connected to the proximal end of the needle body  34   b , and a suture  47  inserted movably in the needle body  34   b  and the needle grip  46 . 
   The needle  4  or  13  can be inserted through the inner sheath port  30  into the inner sheaths  3   a  or  3   b.    
   The needle bodies  34   a  and  34   b  are a metal pipe made of stainless steel or nitinol, which is resistant to pressure from the proximal end during piercing and flexible enough to follow the curvature of the first endoscope  27 . The inner diameter is about 0.5 mm and the outer diameter is about 1 mm. To facilitate projection of the distal end of the needle bodies  34   a  and  34   b  out of the distal end of the inner sheaths  3   a  and  3   b , the outer diameter of the needle bodies  34   a  and  34   b  preferably approximates the inner diameter of the inner sheaths  3   a  and  3   b . The needle bodies  34   a  and  34   b  have two grooves  51   a  and  51   b  near the proximal end. 
   The needle bodies  34   a  and  34   b  slides in the inner sheaths  3   a  and  3   b  by needle grip  35  and  46  moving back and forth against the inner sheath port  30   a  and  30   b . When the O ring  32  of the inner sheath  3  is engaged in the groove  51   a , the distal end of the needle body  34  is positioned slightly proximal than the distal end of the sheath section  33 , and when the O ring  32  is engaged in the groove  51   b , the distal end of the needle body  34  extends out of the distal end of the sheath section  33 . Preferably, the needle body  34  extends out of the distal end of the sheath section  33  by about 50 to 70 mm. Preferably, the distal ends of the needle bodies  34   a  and  34   b  should be apart by at least 10 mm when the needle bodies  34   a  and  34   b  extend out of the distal ends of the sheath sections  33   a  and  33   b.    
   The needle grip  35  comprises a port body  36 , a needle port  37 , and a elastic cylindrical fixing ring  42  between them made of rubber such as silicon rubber or fluororubber, or thermoplastic elastomer. The port body  36  is connected to the proximal end of the needle body  34   a . The port body  36  and the needle port  37  have lumen and are connected with screws. An operation pipe  40  of the suture-holding forceps  38  slides in the lumen. When the needle port  37  is tightened, the fixing ring  42  is pressed longitudinally and expanded radially to fix the operation pipe  40 . The needle port  37  has a narrow section  43  to which the needles-coupling member  6  is connected. The needle grip  46  also has a narrow section  43  to which the needles-coupling member  6  is connected. 
   The suture-holding forceps  38  are inserted in advance into the needle body  34   a  and the needle grip  35  for sliding. 
   The suture-holding forceps  38  has a holding section  41  at the distal end of the operation pipe  40 . The holding section  41  is formed at least two hook shaped nail  50 . The holding section  41  is bent and mounted to the operation pipe  40  so that the central axis  48  of the holding section  41  forming the holding section  41  inclines against the longitudinal axis of the operation pipe  40 . 
   The length L of the holding section  41  is longer than the distance l between the two needle bodies  34   a  and  34   b , and the suture end  49  of the suture  47  extending out of the needle  13  is inserted in the holding section  41 . 
   The holding section  41  is a metal wire made of stainless steel or nitinol, or plastic wire. The wire may be a single wire or a stranded wire. It has the diameter that allows retracting the holding section  41  into the needle body  34   a . The holding section  41  is adjusted to open by 10 to 20 mm when it extends out of the needle body  34   a.    
   The operation pipe  40  extends from the proximal end of the holding section  41  to the proximal end of the needle port  37 . The operation pipe  40  is connected an operation knob  39  at the proximal end. The operation pipe  40  is a slim metal pipe for smooth rotation such as stainless steel or nitinol. The holding section  41  is rotated following the rotation of the operation knob  39 . 
   The suture  47  is a general surgical suture made of, for example, nylon or silk. The suture  47  is 0.2 to 0.5 mm thick, and preferably 0.3 to 0.4 mm thick. 
   The inner sheaths-coupling member  5  can be mounted to the narrow sections  26   a  and  26   b  of the sliders  18   a  and  18   b  detachably. 
   The inner sheaths-coupling member  5  is an elastic yet relatively hard plastic sheet. There are two slits  44   a  and  44   b  on one side, which are connected to coupling holes  45   a  and  45   b.    
   The width of the slits  44   a  and  44   b  are slightly narrower than the outer diameter of the narrow sections  26   a  and  26   b  of the sliders  18   a  and  18   b . The inner diameter of the coupling holes  45   a  and  45   b  is nearly equal to the outer diameter of the narrow sections  26   a  and  26   b . The each distance between the slits  44   a  and  44   b , or coupling holes  45   a  and  45   b  is equal to the distance between the narrow sections  26   a  and  26   b . When the slits  44   a  and  44   b  are pressed to the narrow sections  26   a  and  26   b , the slits  44   a  and  44   b  open to connect the coupling holes  45   a  and  45   b  with the narrow sections  26   a  and  26   b.    
   To remove the inner sheaths-coupling member  5 , the narrow sections  26   a  and  26   b  are pulled out of the slits  44   a  and  44   b.    
   When the inner sheaths-coupling member  5  is mounted to the sliders  18   a  and  18   b , both inner sheaths  3   a  and  3   b  can be moved back and forth at one time either by holding and moving one slider  18  or the inner sheaths-coupling member  5 . The inner sheaths  3   a  and  3   b  extend by the same length out of the openings  15   a  and  15   b.    
   To change the extension length of either inner sheath  3   a  or  3   b , the inner sheaths-coupling member  5  is removed, and the sliders  18   a  and  18   b  are operated separately. 
   The needles-coupling member (switch means)  6  and the inner sheaths-coupling member (switch means)  5  are similarly composed and function as the switch means either singly or together. The needles-coupling member  6  can be detachably mounted to the narrow section  43   a  and  43   b  of the needle ports  37  and the needle grip  46 . According to mounting and removing the needles-coupling member  6 , the needles  4  and  13  are operated at one time or separately. When the separate operation is selected, the extension length of the needles  4  and  13  out of the distal end of the inner sheath  3   a  or  3   b  may be varied. 
   Mounting the Device to an Endoscope ( FIG. 10 ) 
   The piercing device  1  is mounted in the following procedure. The proximal mounting section  20  is mounted to the forceps channel port  28  of the first endoscope  27 . The distal mounting section  12  of the cap  8  is inserted to the distal end of the first endoscope  27  while the outer sheaths  7   a  and  7   b  are held lest they should be twisted. The outer sheaths  7   a  and  7   b  are fixed at several points on the outer periphery of the first endoscope  27  with surgical tape. 
   The inner sheaths  3   a  and  3   b  are inserted through the slider ports  19   a  and  19   b  to the outer sheaths  7   a  and  7   b , and the inner sheath port  30   a  and  30   b  are connected and fixed to the slider ports  19   a  and  19   b . With the suture-holding forceps  38  placed completely into the needle bodies  34   a , the needle  4  is inserted through the inner sheath port  30   a  into the inner sheaths  3   a.    
   With the distal end of the suture  47  placed completely into the needle bodies  34   b , the needle  13  is inserted through the inner sheath port  30   b  into the inner sheaths  3   b . The groove  51   a  of the needle bodies  34   a  and  34   b  should be engaged with the O ring  32  of the inner sheaths  3   a  and  3   b . The needle bodies  34   a  and  34   b  are then positioned so as not to extend out of the distal ends of the sheath sections  33   a  and  33   b.    
   The sliders  18   a  and  18   b  are pulled proximally. The sheath sections  33   a  and  33   b  are pulled in the outer sheaths  7   a  and  7   b  in advance so that the distal ends of the sheath sections  33   a  and  33   b  are positioned more proximally than the openings  15   a  and  15   b.    
   Pulling Up and Penetration the Suture Area ( FIGS. 11 to 13 ) 
   The second endoscope  52  is inserted into the patient body. The distal end of the second endoscope  52  is positioned near sutured tissues  53   a  and  53   b.    
   The sutured tissues  53   a  and  53   b  are grasped and pulled up together by a grasping forceps  54  which is inserted through a forceps channel (not shown) of the second endoscope  52 . The grasping forceps  54  may be of any design and shape as long as it can grasp the sutured tissues  53   a  and  53   b . Next, the first endoscope  27  mounted the piercing device  1  is inserted into the patient&#39;s body. The distal end of the first endoscope  27  is positioned near the sutured tissue  53   a . The sliders  18   a  and  18   b  are moved against the grips  17   a  and  17   b  to the distal end. The sheath sections  33   a  and  33   b  are extended out of the openings  15   a  and  15   b  and pressed against the entering points  55   a  and  55   b . Depending on the relative position between the sutured tissue  53   a  and the distal end of the first endoscope  27 , the inner sheaths-coupling member  5  is either attached to the narrow sections  26   a  and  26   b  to press the sheath sections  33   a  and  33   b  at one time, or is removed to press the sheath sections  33   a  and  33   b  separately. After the sheaths sections  33   a  and  33   b  are pressed, the needle port  37  of the needle grip  35  is tightened to the port body  36  to fix the sliders  18   a  and  18   b.    
   The needle grips  35  and  46  are pressed toward the distal end until the groove  51   b  of the needle bodies  34   a  and  34   b  is engaged with the O ring  32 , and the needle bodies  34   a  and  34   b  are extended out of the sheath sections  33   a  and  33   b.    
   The needles-coupling member  6  is either attached to the narrow sections  43   a  and  43   b  to press the needle bodies  34   a  and  34   b  at one time, or is removed to press the needle bodies  34   a  and  34   b  separately. Pressing the needle bodies  34   a  and  34   b  at one time makes operation easy, but increases penetration resistance of the needles and requires more force to penetrate them into tissue. On the other hand, pressing the needle bodies  34   a  and  34   b  separately makes it easy to penetrate the tissue, but requires two rounds of penetration procedures. When the needle bodies  34   a  and  34   b  are extended out of the sheath sections  33   a  and  33   b , they pass through the entering points  55   a  and  55   b  of the sutured tissue  53   a  and the exiting points  56   a  and  56   b  of the sutured tissue  53   b.    
   The second endoscope  52  is used to check that the needle bodies  34   a  and  34   b  project from the sutured tissue  53   b . In the first embodiment two needle bodies  34   a  and  34   b  are penetrated through the sutured tissues  53   a  and  53   b  when the surface comprised with the needle bodies  34   a  and  34   b  locates tissue  59  vertically. The needle bodies  34   a  and  34   b  may be penetrated when the surface locates tissue  59  horizontally. In the case, suture area spreads horizontally. 
   Inserting a Suture into Tissue ( FIGS. 14 to 16 ) 
   The operation knob  39  of the needle  4  is pressed toward the distal end and the holding section  41  is extended out of the distal end of the needle body  34   a  while it is observed by the second endoscope  52 . The operation knob  39  is rotated while it is observed by the second endoscope  52  to rotate the holding section  41  until the longitudinal axis of the needle body  34   b  is positioned in the holding section  41 . The suture  47  in the needle  13  is pressed out, and the suture end  49  is inserted in the holding section  41 . 
   The operation knob  39  is pulled proximally to pull the holding section  41  into the needle body  34   a  and hold the suture end  49 . The needle port  37  of the needle grip  35  is tightened to the port body  36  to lock the holding section  41  and the suture end  49 . 
   Next, with the suture  47  extending from the proximal end of the needle grip  46  released, the needle grips  35  and  46  are pulled back proximally to retract the distal ends of the needle bodies  34   a  and  34   b  into the sheath sections  33   a  and  33   b . Thus, the suture end  49  penetrates the sutured tissues  53   a  and  53   b.    
   The slide locks  22   a  and  22   b  are loosened, and the grips  18   a  and  18   b  are pulled back proximally to pull the distal ends of the sheath sections  33   a  and  33   b  in the outer sheaths  7   a  and  7   b . With the suture  47  extending from the proximal end of the needle grip  46  released, the first endoscope  27  and piercing device is then removed from the patient body. The needle port  37  of the needle grip  35  is loosened to port body  36 , and the operation knob  39  is pressed toward the distal end to remove the suture ends  49  out of the holding sections  41 . 
   Next, with the suture end  49  held, the first endoscope  25  mounted piercing device  1  is pulled back proximally to pull out another suture end  57  of the suture  47  from the distal end of the needle body  34   b . After the sutured tissues  53   a  and  53   b  is released from the grasping forceps  54 , the grasping forceps  54  and second endoscope  52  is removed from the patient body. 
   Fixing the Suture ( FIGS. 17 and 18 ) 
   The suture ends  49  and  57  are tied outside the patient body to form a knot  58 . The knot  58  can be any knot as long as it is generally used in surgical operation. The knot  58  is advanced into the patient body by a general knot pusher introduced through a forceps channel of the first endoscope  27  of the second endoscope  52  while it is observed by the either endoscope. 
   When the knot  58  reaches near the entering points  55   a  and  55   b  of the sutured tissue  53   a , the knot pusher is pressed against the sutured tissue  53   a , while the suture ends  49  and  57  are pulled to lock the knot  58 . 
   The above procedure is repeated several times before it is checked that the knot  58  is tied firmly. Then the endoscope and the knot pusher are removed from the patient body. 
   Finally, excess sutures beyond the knot  58  are cut using endoscopic scissors, and are collected outside the body. Depending on length and area of the sutured tissue  53   a  and  53   b , the above procedure is repeated to suture the sutured tissue  53   a  and  53   b  completely. 
   The piercing device  1  is so designed that the sheath sections  33   a  and  33   b  touch the targeted penetration point before the needle bodies  34   a  and  34   b  are actually thrust into the tissue. This provides easy location of the penetration point before penetration is actually performed with the needles, as well as delicate control of the location. As a result, an accurate suture, an easy operation for the treatment, and a great reduction in treatment time are implemented. 
   Integrated beforehand into the piercing device  1  are two penetration needles. Therefore, once the distal end of the endoscope  27  approaches the point of penetration on the sutured tissue  53   a , the two needles are ready for immediate penetration. This feature also contributes to easy operation and great reduction in treatment time. 
   The piercing device  1  is equipped with two penetration needles located in parallel to each other at a fixed interval beforehand. This allows the sutured tissues  53   a  and  53   b  to be sutured at a fixed interval when a number of stitches are made, ensuring the suture accuracy. 
   The outer sheaths  7   a  and  7   b  that the needles  4   a  and  4   b  are inserted through are mounted onto the cap  8  beforehand at a given point. Therefore, once the cap  8  is mounted on the distal end of the endoscope  27 , both outer sheaths  7   a  and  7   b  can be readily mounted at a location given against the distal end of the endoscope  27 . This also contributes to reduction in the time required for mounting it onto the endoscope. 
   Penetration with the needle bodies  34   a  and  34   b  is performed on the sutured tissues  53   a  and  53   b  while they are grasped and pulled up with the grasping forceps  54  inserted through the second endoscope  52 . Thus the penetration area and therefore the suture area are to be selected at will. 
   The penetration area can be extended when the sutured tissues  53   a  and  53   b  are further pulled up. As a means of pulling up the sutured tissues  53   a  and  53   b , the grasping forceps  54 , independent of the piercing device  1 , are used. This contributes to considerable miniaturization of the piercing device  1  itself, providing easy insertion into the body lumen of the patient, and reducing the pain caused to the patient when the piercing device  1  is inserted into the body lumen. 
   Since the need for inserting a suture thread or other material from the distal end of the needle bodies  34   a  and  34   b  is eliminated, there will be no danger of the operator being accidentally pricked with a needle. 
   Second Embodiment (FIGS.  19  to  21 ) 
   Only points different from those of the first embodiment are described. 
   A piercing device  100  is the piercing device  1  with the needles-coupling member  6  replaced by a needles-coupling member  101 . The needles-coupling member  101  comprising a distal section  102 , a middle section  103  and a proximal section  104 , and is shaped like a crank. The distal section  102  and the proximal section  104  are positioned longitudinally apart each other. The distal section  102  should be apart from the proximal section  104  by at least the thickness of tissue to be penetrated, or at least 5 mm. 
   Coupling holes  45   a  and  45   b  of the needles-coupling member  101  are mounted via the slits  44   a  and  44   b  to the narrow sections  43   a  and  43   b  of the needle port  37  and needle grip  46 . Because the distal section  102  and the proximal section  104  are apart each other, the distal ends of the needle bodies  34   a  and  34   b  are longitudinally apart from each other. When the needles-coupling member  101  is held and pressed toward the distal end, the needle bodies  34   a  and  34   b  are extended out of the inner sheaths  33   a  and  33   b  with its distance between the two maintained. 
   When the piercing device  100  is used for penetrating the sutured tissues  53   a  and  53   b , first needle body  34   b  penetrates the sutured tissues  53   a  and  53   b ; next needle body  34   a  penetrates them. 
   Because two needles never penetrates tissue at one time even if the needles coupling-member  101  is pressed to operate the two needles, penetration resistance will not be increased, and penetration is easy. 
   In the arrangement described above, the following operational advantages are gained. 
   The piercing device provides easy location of the penetration point before penetration is actually performed with the needles, as well as delicate control of the location. As a result, accurate suture, easy operation for treatment, and great reduction in treatment time are implemented. 
   Integrated into the piercing device are two penetration needles beforehand. Therefore, once the distal end of the endoscope approaches the targeted point of penetration on the tissue, the two needles are ready for immediate penetration. This feature also contributes to easy operation and great reduction in treatment time. 
   The piercing device is equipped with two penetration needles located in parallel to each other at a fixed interval beforehand. This allows the tissues to be sutured at a fixed interval when a number of stitches are made, ensuring the suture accuracy. 
   The two penetration needles are mounted beforehand at a given point on the cap that is provided at the distal end of the piercing device. Therefore, once the cap is mounted on the distal end of the endoscope, both two needles are readily mounted at a location given against the distal end of the endoscope. This also contributes to reduction in time required for mounting the device onto the endoscope. 
   Since the need for inserting a suture thread or other material from the distal end of the needle into the needle is eliminated, there will be no danger of the operator being accidentally pricked with a needle. 
   Penetration is performed on the in-vivo tissues while they are grasped and pulled up with the grasping forceps independent of the piercing device. Thus the penetration area and, therefore, the suture area are to be selected at will. The penetration area can be extended when the tissues are further pulled up. As a means of pulling up the tissues, the grasping forceps independent of the piercing device are used. This contributes to considerable miniaturization of the piercing device itself, providing easy insertion into the body lumen of the patient, and reducing the pain subject to the patient when the piercing device is inserted into the body lumen.