Patent Publication Number: US-2011071354-A1

Title: Overtube and medical procedure via natural orifice using the same

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     The present application is a continuation of U.S. patent application Ser. No. 11/435,182, filed on May 16, 2006 which is a continuation-in-part application of U.S. patent application Ser. No. 11/331,938, filed on Jan. 13, 2006, the contents of which were entirely incorporated herein by reference. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     This invention relates to an overtube and a medical procedure using the overtube that is performed via a natural orifice. 
     2. Description of Related Art 
     Laparoscopic operations are known in which, in performing a medical procedure of observing, treating, etc. an organ of the human body, instead of incising the abdominal wall widely, a plurality of orifices are opened in the abdominal wall and procedures are performed upon inserting a laparoscope, forceps, and other treatment instruments into the orifices. Such procedure provides the benefit of lessening the burden placed on the patient because only small orifices need to be opened in the abdominal wall. 
     In recent years, methods of performing procedures upon inserting a flexible endoscope via the mouth, nose, anus, or other natural orifice of the patient have been proposed as methods of further reducing the burden on the patient. An example of such procedures is disclosed in U.S. Pat. No. 5,458,131. 
     With this method, a flexible endoscope is inserted from the mouth of a patient, an opening is formed in the stomach wall, and a distal end part of the endoscope is fed into the abdominal cavity from the opening. Then while using the endoscope as a device for observing the interior of the abdominal cavity, desired procedures are performed inside the abdominal cavity using a treatment instrument inserted through the endoscope or a treatment instrument inserted from another opening. 
     SUMMARY OF THE INVENTION 
     An object of this invention is to provide a device and a method that enable incision of tissue to be performed more readily in performing a medical procedure using an overtube. 
     An overtube according to a first aspect of this invention includes: an insertion part, that is inserted into a subject and has a lumen, through which a device insertion part of a device for performing a medical procedure inside a body of the subject is removably inserted, the insertion part being inserted into the subject; and a tissue incising part that is disposed at a distal end side of the insertion part so as to cross the lumen and incises a tissue of the subject. 
     An overtube according to a second aspect of this invention includes: an insertion part, that is opened at a distal end, inserted into a subject, and has a lumen, through which a device insertion part of a device for performing a medical procedure inside a body of the subject is removably inserted, the insertion part being inserted into the subject; and a tissue incising part that crosses a distal end side of the lumen is disposed at the insertion part so as to allow withdrawing of the crossing state, and incises a tissue of the subject. 
     A medical procedure through a natural orifice according to a third aspect of this invention includes: inserting a device that extends in an axial direction into a lumen disposed in an insertion part of an overtube and inserting the insertion part into a hollow organ through a natural orifice of a subject; guiding the insertion part to an incision target site while using an observation device to observe the incision target site; using a tissue incising part, disposed at a distal end side of the insertion part, to incise the incision target site and form an opening; and introducing at least one of an operative device and the overtube into an abdominal cavity via the opening. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a schematic view of an entirety of an overtube according to a first embodiment. 
         FIG. 2  is a view of principal portions of the overtube according to the first embodiment. 
         FIG. 3  is a perspective view of a distal end part of the overtube according to the first embodiment. 
         FIG. 4A  is a sectional view taken along line III-III of  FIG. 3 . 
         FIG. 4B  is a sectional view taken along line IV-IV of  FIG. 4A . 
         FIG. 5  is a partially enlarged section of an electrode manipulating part of the overtube according to the first embodiment. 
         FIG. 6A  is an entire view of double T-bars used in the embodiment. 
         FIG. 6B  is a sectional view of a state in which the double T-bars are fitted into a puncture needle of the overtube according to the first embodiment. 
         FIG. 7  is a partial sectional view of a needle manipulating part of the overtube according to the first embodiment. 
         FIG. 8  is a sectional view of a portion near an endoscope lock button of the overtube according to the first embodiment. 
         FIG. 9  is an entire schematic view of an endoscope as an example of a device used for the overtube according to the first embodiment. 
         FIG. 10  is a flowchart of a medical procedure according to the first embodiment. 
         FIG. 11  is a view for describing a state of inserting the endoscope into the overtube in the medical procedure according to the first embodiment. 
         FIG. 12  is a view for describing a state of introducing the overtube to an incision target site in the medical procedure according to the first embodiment. 
         FIG. 13  is a view for describing a state of suctioning a portion of a stomach wall into the overtube in the medical procedure according to the first embodiment. 
         FIG. 14  is a view for describing a state of puncturing the suctioned stomach wall by means of the puncture needle of the overtube in the medical procedure according to the first embodiment. 
         FIG. 15  is a view for describing a state of insufflation of an abdominal cavity by feeding of air from a hypodermic needle in the medical procedure according to the first embodiment. 
         FIG. 16  is a view for describing a state of releasing anchors of the double T-bars from the puncture needle in the medical procedure according to the first embodiment. 
         FIG. 17  is a view for describing a state of incising the suctioned stomach wall by means of the incising electrode of the overtube in the medical procedure according to the first embodiment. 
         FIG. 18  is a view of  FIG. 17  viewed from a direction rotated by 90 degrees. 
         FIG. 19  is a view for describing a state of inserting the endoscope into the abdominal cavity in the medical procedure according to the first embodiment. 
         FIG. 20  is a view for describing a state of pulling and constricting a string of the double T-bars that have been placed in the medical procedure according to the first embodiment. 
         FIG. 21  is a view of principal portions of an overtube according to a second embodiment. 
         FIG. 22  is a sectional view taken along line A-A of  FIG. 21 . 
         FIG. 23  is a flow chart of a medical procedure according to the second embodiment. 
         FIG. 24A  is a view for describing a state of making an endoscope inserting part protrude from the overtube in the medical procedure according to the second embodiment. 
         FIG. 24B  is a view for describing a state of using the endoscope inserting part as a guide and using a second magnet of the overtube to move the overtube inside an abdominal cavity from the state shown in  FIG. 24A . 
         FIG. 25A  is a view for describing a state of making the endoscope inserting part protrude along with the overtube from an orifice in the medical procedure according to the second embodiment. 
         FIG. 25B  is a view for describing a state of using the second magnet of the overtube to move the endoscope inserting part and the overtube inside the abdominal cavity from the state shown in  FIG. 25A . 
         FIG. 26  is a view for describing a state of using the first magnet of the overtube to support the overtube inside the abdominal cavity in the medical procedure according to the second embodiment. 
         FIG. 27  is a view for describing a state of using the first magnet and third magnet of the overtube to change the direction of the overtube inside the abdominal cavity in the medical procedure according to the second embodiment. 
         FIG. 28  is a perspective view of a modification example of principal portions of an overtube. 
         FIG. 29  is a perspective view of another modification example of principal portions of an overtube. 
         FIG. 30  is an entire schematic view showing a modification example of the overtube according to the first embodiment. 
         FIG. 31  is a perspective view showing the distal end part in a modification example of the overtube according to the first embodiment. 
         FIG. 32  is a cross-sectional view showing the state in which the double T-bar has been attached to the puncture needle in a modification example of the overtube according to the first embodiment. 
         FIG. 33  is a cross-sectional view showing the state in which the double T-bar has been attached to the puncture needle in a modification example of the overtube according to the first embodiment. 
         FIG. 34  is a cross-sectional view showing the state after puncturing with the puncture needle in a modification example of the overtube according to the first embodiment. 
         FIG. 35  is an entire schematic view showing another modification example of the overtube according to the first embodiment. 
         FIG. 36  is a perspective view showing the distal end part in another modification example of the overtube according to the first embodiment. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Embodiments according to the present invention will now be described in detail below. In the following description, components that are the same shall be provided with the same numeric symbol and redundant description shall be omitted. 
     First Embodiment 
     An overtube  1  according to this embodiment is used as a guide tube for inserting, into a body, an endoscope or other device, for carrying out a medical procedure inside a body and being equipped with an insertion device part that is inserted inside a subject (to simplify the description, the device may be referred to simply as “device” or “endoscope” below). As shown in  FIG. 1 , the overtube  1  includes: an insertion part  5  that is opened at a distal end, inserted into a stomach or other hollow organ or abdominal cavity, etc., of a patient (subject) and has a lumen  3 , through which an endoscope  2 , as one example of a device extending along an axial direction, is removably inserted; an incising electrode (tissue incising part)  6  that crosses a distal end side of the lumen  3 , is disposed in the insertion part  5  so as to allow withdrawing of the crossing state, and incises an internal tissue of the patient; electrode manipulating wires (manipulating members)  7 A and  7 B that are each connected to the incising electrode  6  and are disposed in a manner enabling advancing and retracting with respect to the insertion part  5 ; an electrode manipulating part (manipulating part)  8  that is for manipulating the electrode manipulating wires  7 A and  7 B to advance and retract with respect to the lumen  3 ; and a needle manipulating part  10  that is for manipulating a puncture needle  32 A,  32 B, and pusher  35  to be described later. Though in the present embodiment, the incising electrode  6  and the electrode manipulating wires  7 A and  7 B are arranged from a single wire, the incising electrode  6  and electrode manipulating wires  7 A and  7 B may be arranged as separate members that are connected to each other. Also, the incising electrode  6  may be disposed so as not to be able to advance and retract with respect to the insertion part  5 . 
     As shown in  FIG. 2 , the insertion part  5  is elongated and flexible, and as with a normal flexible endoscope, a bending part  13 , in which a plurality of joint rings  11  are connected along bending wires  12 , is disposed at a distal end side of the insertion part  5 . Here, instead of providing the bending part  13  that is actively bended by manipulation by an operator, the insertion part may be arranged in a tube-like shape with flexibility and to be bended passively in accordance with a bending state of the endoscope, etc. A distal end part  15  having a short pipe shape is disposed further at the distal end of the bending part  13  as shown in  FIG. 3 . 
     The incising electrode  6  is, for example, a stainless steel wire to which high-frequency electricity can be energized and is disposed so as to cross a center of the lumen  3  in a direction orthogonal to an axial direction of the insertion part  5 . That is, as shown in  FIGS. 3 and 4 , one end side of the incising electrode  6  is inserted through a first inner groove  16 , formed on an outer edge of the lumen  3  that is an inner surface of the distal end part  15  (in other words, an inner periphery of the distal end part  15  that defines the lumen  3 ), and is connected to the electrode manipulating wire  7 A. The other end side of the incising electrode  6  is inserted through a second inner groove  17 , formed on the outer edge of lumen  3  (in other words, the inner periphery of the distal end part  15  that defines the lumen  3 ) at a position substantially symmetrically across the center of the lumen  3  from the first inner groove  16 , and is connected to the electrode manipulating wire  7 B. The incising electrode  6  is formed so that its length is longer than the inner diameter of the lumen  3 , and as shown in  FIG. 4 , the incising electrode  6  is accommodated in the lumen  3  with a bended state, and is movable along the first inner groove  16  and second inner groove  17 . Though in the embodiment shown in  FIG. 4 , the length of the incising electrode  6  is set longer than the inner diameter of the lumen  3 , this invention is not restricted thereto, and the length of the incising electrode  6  may be set (for example, to a length substantially equal to the inner diameter of the lumen  3 ) so that the incising electrode  6  is accommodated in the lumen  3  with a non-bended state. 
     The electrode manipulating wires  7 A and  7 B are inserted through an electrode tube  18 . The electrode tube  18  is provided with a single tube at a proximal end side that protrudes outside the insertion part  5 . As shown in  FIG. 1 , the electrode tube  18  branches into two at a middle portion, and are connected at a distal end to the distal end part  15 , so that the electrode manipulating wires  7 A and  7 B are accommodated separately in the insertion part  5 . As shown in  FIG. 5 , the proximal ends of the electrode manipulating wires  7 A and  7 B are inserted through a single, rigid manipulating pipe  19  disposed to protrude from a distal end of a manipulating handle  21  to be described later. 
     As shown in  FIGS. 1 and 5 , the electrode manipulating part  8  includes a manipulating body  20 , which is connected to the proximal end of the electrode tube  18 , and a manipulating handle  21 , which is disposed to be able to advance and retract freely with respect to the manipulating body  20 . The manipulating body  20  is provided with an insertion hole  20   a , through which the electrode manipulating wires  7 A and  7 B and the manipulating pipe  19  are inserted. At a distal end of the manipulating body  20  is formed an engagement hole  20   b,  which engages with a rigid part  18 A disposed at the proximal end of the electrode tube  18 , and the electrode tube  18  is fixed to the engagement hole  20   b  by a screw  22 . A finger ring  20 A is disposed at a proximal end of the manipulating body  20 . 
     A connection plate  23  is disposed at the manipulating handle  21 . The connection plate  23  is electrically connected to end parts of the electrode manipulating wires  7 A and  7 B inserted through the manipulating pipe  19 . A fixing screw  24  is disposed at the connection plate  23 , and by screwing the fixing screw  24  into the connection plate  23 , the electrode manipulating wires  7 A and  7 B are fixed and electrically connected. The connection plate  23  is electrically connected via an electric wiring  25  to a connection terminal  26 A disposed in the manipulating handle  21 . A connection terminal  26 B, disposed at a distal end of a power supply cord  28  that extends from a high-frequency power supply  27 , is detachably attached to the connection terminal  26 A. The manipulating handle  21  is also provided with finger rings  21 A. 
     On an outer surface of the distal end part  15  of the overtube  1 , a first outer groove  30  and a second outer groove  31  are formed from a middle portion to the distal end of the distal end part  15  at positions orthogonal to a direction joining the first inner groove  16  and the second inner groove  17 . The two puncture needles (hollow needles)  32 A and  32 B, which advance and retract along the lumen  3 , are movably disposed in advancing and retracting directions in the first outer groove  30  and the second outer groove  31 , respectively. Two anchors  33 A of double T-bars  33 , shown in  FIG. 6A , are respectively held inside the respective puncture needles  32 A and  32 B as shown in  FIG. 6B . 
     The double T-bars  33  have two sutures  33 C, one end side of each of which is passed through a substantially triangular stopper  33 B. At one end, the sutures  33 C are bound together to form a large diameter part  33 C a . Each of the other ends of the sutures  33 C is fixed to the anchors  33 A. Each anchor  33 A has a cylindrical shape with a slit formed at an end, and the suture  33 C is inserted in the longitudinal direction of the interior of anchor  33 A through the slit. The large diameter part  33 C a  that has greater diameter than that of the anchor  33 A is formed at the other end of the suture  33 C. The stopper  33 B has a hole, through which the sutures  33 C are passed, at a center in the longitudinal direction of an elongated, thin plate member. The respective ends in the longitudinal direction of the stopper  33 B are folded obliquely and sandwich the sutures  33 C. The respective ends in the longitudinal direction of the stopper  33 B are cut to notches of triangular shape. With the stopper  33 B, the respective ends are folded back obliquely so that the notches intersect and thereby sandwich the sutures  33 C. The sutures  33 C thus do not fall off from between the ends. When the large diameter part  33 C a  of the sutures  33 C is pulled in a direction away from the stopper  33 B, the respective end parts of the stopper  33 B spread apart slightly. The stopper  33 B thus allows movement of the sutures  33 C in this direction. Meanwhile, when a large diameter part  33 C a  at the anchor  33 A side of a suture  33 C is pulled, a tendency for the suture  33 C to move in the direction indicated by the arrow in  FIG. 6A  arises. However, since the respective ends of the stopper  33 B close and grasp the sutures  33 C in this process, the suture  33 C does not move. 
     As shown in  FIG. 6B , the pusher  35  is movably disposed in advancing and retracting directions in the interior of the respective puncture needles  32 A and  32 B. As shown in  FIG. 1 , the stopper  33 B of the double T-bars  33  is accommodated inside a hole (receiving part) (referred to hereinafter simply as “hole”)  37  formed from a proximal end side to the distal end side of a side face of the insertion part  5 . 
     The puncture needles  32 A and  32 B and pushers  35  are respectively accommodated in two outer sheaths  38 . Each of the two outer sheaths  38  is inserted through the insertion part  5  and has a distal end connected to the distal end part  15 . A slit  32   a,  through which a suture  33 C of the double T-bars  33  is inserted, is formed at a distal end of each of the puncture needles  32 A and  32 B. A rigid, pushing member  35 A is disposed at a distal end of the pusher  35 . 
     As shown in  FIGS. 1 and 7 , the needle manipulating part  10  includes: a sheath holding part  40 , connected to the proximal ends of the two outer sheaths  38 ; a needle manipulating handle  41 , connected to proximal ends of the two puncture needles  32 A and  32 B that have been passed in a manner enabling advancing and retracting through through-holes  40   a  formed in the sheath holding part  40 ; and a pusher connection part  43  that connects end portions of rod-like, rigid parts  42 , which are passed in a manner enabling advancing and retracting through through-holes  41   a  formed in the needle manipulating handle  41  and are connected to proximal ends of the two pushers  35 , to each other. The needle manipulating handle  41  is provided with finger rings  41 A. Each of the needle manipulating handle  41  and the pusher connection part  43  may be divided into two parts so as to enable the two puncture needles  32 A and  32 B and the two pushers  35  to be manipulated independently of each other. 
     As shown in  FIG. 2 , a proximal handle  44  having a larger diameter than the insertion part  5 , is disposed at the proximal end of the insertion part  5  of the overtube  1 . The proximal handle  44  includes a bending lever  45 , a bending lock lever  46 , and an endoscope lock button  47 . The bending lever  45  is connected to the proximal ends of the bending wires  12  for performing bending manipulation of the bending part  13 . The bending lock lever  46  is used for fix the position of the bending lever  45  at an arbitrary position. The endoscope lock button  47  is used for fix the endoscope  2  with respect to the lumen  3  upon insertion of the endoscope  2  through the lumen  3 . 
     The distal ends of the bending wires  12  are fixed to the distal end part  15 , and in the present embodiment, the two bending wires  12  are inserted through the interior of the insertion part  5  and the distal ends thereof are fixed to portions of the distal end part  15  that substantially oppose each other across the center of the lumen  3 . Though in this embodiment, two bending wires  12  are provided to enable bending of the bending part  13  in two directions, this invention is not limited thereto, and four bending wires  12  and two bending levers  45  may be provided as in a bending part of a known endoscope to enable bending of the bending part in four directions. 
     As shown in  FIG. 8 , the endoscope lock button  47  has a pressing part  47 A of wide width disposed at a distal end and which is normally urged in an outward radial direction of the proximal handle  44  by a spring  48 . When the endoscope  2  must be fixed to the insertion part  5  upon being inserted through the interior, the endoscope lock button  47  is pressed inward in the radial direction so that the pressing part  47 A presses and fixes the endoscope  2  in a relative manner by a frictional force. The endoscope lock button  47  may be arranged so as to oppositely release the frictional force when pressed. 
     The endoscope  2 , which is inserted into the overtube  1 , is, for example, a flexible endoscope and, as shown in  FIG. 9 , an endoscope inserting part  51 , which is elongated and inserted into a patient&#39;s body, extends outward from an endoscope manipulating part  50  manipulated by an operator. An endoscope distal end part  52  of the endoscope inserting part  51  can be bended by manipulating an angle knob  53  disposed at the endoscope manipulating part  50 . At the endoscope distal end part  52  are disposed an objective lens  55 , a distal end face of an optical fiber  57  that guides light from a light source device  56  disposed outside the body, and distal end openings of channels  58  and  60 . The channel  58  is a duct that is connected via a universal cable  61  to an air/water feeding device  62  or a suction device  63  disposed outside the body and is used to supply or drain fluid to or from inside the body. The channel  60  is a duct for inserting and removing a treatment instrument and is disposed at a position of six o&#39;clock to eight o&#39;clock of the endoscope inserting part  51 . The number of treatment instrument channels is not restricted to one and, for example, two treatment instrument channels may be provided. An observation image inputted into the objective lens  55  is displayed on a monitor  66  via a control unit  65 . 
     Actions of the present embodiment shall now be described in line with a medical procedure performed via a natural orifice using the overtube  1  as shown by the flow chart of  FIG. 10 . In the following description, it shall be deemed that an incision target site T is located on an anterior wall of a stomach ST, and a surgical procedure of inserting the endoscope  2  into the stomach (hollow organ) ST from a mouth M of a patient PT and performing treatment upon forming an opening SO in the stomach wall and inserting the insertion part  5  of the endoscope  2  into an abdominal cavity AC shall be described. Also, though in the embodiment described below, the endoscope  2  is introduced as a device into the body from the mouth M of the patient PT and made to approach the abdominal cavity AC upon forming the opening SO in the anterior wall of the stomach ST, the natural orifice from which the endoscope  2  is introduced is not restricted to the mouth M and may be another natural orifice, such as the anus, nose, etc. Furthermore, though the forming of the opening SO in the anterior wall of the stomach ST is desirable, this invention is not restricted thereto, and an opening may be formed on a wall of the esophagus, small intestine, large intestine or other hollow organ (hollow organ) besides the stomach ST into which a device is introduced via a natural orifice. 
     First, with the patient PT being made to lie in a supine position, an inserting step (S 10 ) of inserting the endoscope  2  through the lumen  3  in the insertion part  5  of the overtube  1  and inserting the insertion part  5  of the overtube  1  and the endoscope  2  into the stomach (hollow organ) ST from the mouth M of the patient PT while observing the interior of the body cavity by means of an endoscopic image is performed. As shown in  FIG. 11 , a mouthpiece  67  is fitted onto the mouth of the patient PT and the overtube  1  and the endoscope  2  are inserted, with the endoscope  2  being inserted through the interior of the lumen  3 , into the esophagus ES from the mouthpiece  67 . It shall be deemed that the incising electrode  6  and the puncture needles  32 A and  32 B are all accommodated and positioned at initial positions inside the distal end part  15 . 
     Next, in a distending step (S 20 ), air is supplied from the air/water feeding device  62  via the channel  58  of the insertion part  5  to inflate the stomach ST. 
     A guiding step (S 30 ) of guiding the insertion part  5  of the overtube  1  to the incision target site T while checking the incision target site T using the endoscope  2 , which is also an observation device, is then performed. First, after inserting the endoscope inserting part  51  of the endoscope  2  into the stomach ST, the angle knob  53  is manipulated to bring the distal end of the endoscope inserting part  51  close to the incision target site T while observing the interior of the stomach ST via the objective lens  55 , disposed at the endoscope inserting part  51 . Then with the incision target site T being specified, the endoscope inserting part  51  is used as a guide to push the insertion part  5  of the overtube  1  and bring the distal end part  15  of the overtube  1  close to the incision target site T as shown in  FIG. 12 . 
     A needle moving step (S 40 ), of advancing and retracting the puncture needles  32 A and  32 B, disposed at the distal end side of the insertion part  5 , along the lumen  3 , is then performed. First, in a suctioning step (S 41 ), a stomach wall that includes the incision target site T is sucked in by the suction device  63  via the channel  58 , with the distal end part  15  being put in contact with the stomach wall. In this process, a portion of the stomach wall is sucked into the distal end part  15  as shown in  FIG. 13 . A space is thereby secured between an outer side of the stomach wall and the abdominal cavity AC. The means for suctioning the stomach wall is not restricted to the method of using the channel  58  of the endoscope  2 . For example, a space, formed between an inner surface of the lumen  3  of the overtube  1  and an outer periphery of the insertion part  5  of the endoscope  2  or other device inserted into the lumen  3 , may be used as a suction channel and suction may be performed upon connecting the channel to the suction device  63 . In this case, a valve (not shown) that controls the flow of fluid between the interior and exterior of the body may be provided in the formed space to further improve the suction effect. 
     An abdominal cavity insufflating step (S 42 ) is then performed. First, an injection needle  68  connected to the air/water feeding device  62  is inserted through the channel  60  of the endoscope  2 . A distal end of the injection needle  68  is then protruded inside the distal end part  15 , and as shown in  FIG. 14 , pierced through the suctioned stomach wall and inserted to the abdominal cavity AC. Because the injection needle  68  is pierced with the stomach wall being sucked in and a space being secured with respect to the abdominal cavity AC, just the stomach wall can be punctured reliably. Air is then fed into the abdominal cavity AC via the injection needle  68  to insufflate the abdominal cavity AC so that the stomach ST and the abdominal cavity AC separate. 
     The injection needle  68  preferably has a needle length of approximately 12 mm and more preferably has a bendable distal end to enable piercing of the center of the suctioned stomach wall. In this case, a bended injection needle has a bending tendency at a distal end and has a bending wire (not shown) that passes from the distal end toward a proximal side in an inward radial direction of the bending tendency. Here, since the channel  60  of the endoscope  2  is disposed at a position of six o&#39;clock to eight o&#39;clock of the endoscope inserting part  51 , the incision site is approached from an upward angle in incising the anterior stomach wall of the stomach ST that is preferable as the incision site. Since the bending wire thus faces the center due to the bending tendency following the bended state of the insertion part  5  of the overtube  1 , the center of the stomach wall can be punctured reliably by pulling the bending wire toward the proximal side. In the process of feeding air, the interior of the abdominal cavity AC may be maintained at an appropriate pressure by monitoring and automatic control of the feed air pressure. 
     A placing step (S 43 ) is then performed. First, the needle manipulating handle  41  is advanced in the direction of the sheath holding part  40  while holding the sheath holding part  40  to make the puncture needles  32 A and  32 B protrude from the first outer groove  30  and the second outer groove  31 , respectively, of the distal end part  15  and pierce the stomach wall as shown in  FIG. 15 . From this state, the pusher connection part  43  is advanced with respect to the needle manipulating handle  41  to move the pushers  35  toward the distal ends of the puncture needles  32 A and  32 B. In this process, the anchors  33 A of the double T-bars  33  are pressed by the pushers  35  and delivered out from inside the puncture needles  32 A and  32 B and into the interior of the abdominal cavity AC as shown in  FIG. 16 . Here, since the hole  37  is formed so that it is directed from the proximal end side toward the distal end side of the insertion part  5 , unintended falling off of the stopper  33 B of the double T-bars  33  is prevented. Here, since the abdominal cavity AC is insufflated to secure a space with respect to the stomach wall, just the stomach can be punctured. 
     After the anchors  33 A of the double T-bars  33  have been released, the pusher connection part  43  is retracted with respect to the needle manipulating handle  41 , and furthermore, the needle manipulating handle  41  is retracted with respect to the sheath holding part  40  to respectively accommodate the puncture needles  32 A and  32 B inside the first outer groove  30  and the second outer groove  31  again. In this process, the two anchors  33 A of the double T-bars  33  are put in a T-like state by the bending tendencies of the sutures  33 C. Thereafter, by holding and drawing the sheath holding part  40  towards the proximal side, the puncture needles  32 A and  32 B are removed from the distal end part  15  and by furthermore drawing the puncture needles out from the overtube  1 , the bending property of the bending part  13  is secured. 
     An incising step (S 50 ) is then performed. First, it is checked whether the connection terminal  26 A of the electrode manipulating part  8  is connected to the connection terminal  26 B of the power supply cord  28 . Then, while supplying the high-frequency power from high-frequency power supply  27 , the manipulating handle  21  is advanced with respect to the manipulating body  20  to make the incising electrode  6  protrude from the distal end part  15  and contact the stomach wall. In this process, since the electricity is supplied to the incising electrode  6  via the electrode manipulating wires  7 A and  7 B, the stomach wall is incised by the incising electrode  6  and the opening SO is formed in the stomach wall as shown in  FIGS. 17 and 18 . By continuing the suctioning of the stomach wall in this step, the position of placement of the double T-bars  33  and the incision position are put in an optimal state. 
     A removing step (S 60 ) is then performed. Here, in order to remove the incising electrode  6  from inside the insertion part  5 , the fixing screw  24  of the manipulating body  20  of the electrode manipulating part  8  is loosened. In this process, the electrode manipulating wires  7 A and  7 B separate from the connection plate  23  and the electrode manipulating wires  7 A and  7 B become severed. Then, for example, an end part of the electrode manipulating wire  7 A is held and drawn toward the proximal side to move the electrode manipulating wire  7 A through the lumen  3  to the proximal end side and move the electrode manipulating wire  7 B through the lumen  3  to the distal end side. Eventually, the electrode manipulating wire  7 B also moves around the distal end opening of the lumen  3  and toward the proximal end side. The incising electrode  6  is thereby drawn out along with the electrode manipulating wires  7 A and  7 B. 
     An introducing step (S 70 ) is then performed. That is, as shown in  FIG. 19 , the endoscope inserting part  51  of the endoscope  2 , which is also an operative device, is introduced into the abdominal cavity AC through the opening SO. If, in this process, relative movement of the insertion part  5  and the endoscope inserting part  51  must be restricted, the endoscope lock button  47  is pressed and contacted against the endoscope inserting part  51  to fix the movement of the endoscope inserting part  51  by the frictional force. Since the endoscope lock button  47  is provided, the endoscope lock button  47  can be manipulated to restrain relative movement of the endoscope  2  with respect to the overtube  1 , and the overtube  1  and the endoscope  2  can thus be inserted into the body simultaneously. Also, since the task of inserting the endoscope  2  can be performed while holding the proximal handle  44  of the overtube  1 , an operation, in which the insertion part  5  of the overtube  1  is supported by one hand of the operator and the proximal handle  44  is held by the other hand, is enabled, and the operability is thus more improved. 
     When the overtube  1  is introduced into the abdominal cavity AC through the opening SO, the site of placement of the anchors  33 A of the double T-bars is set at the proximal side of the position of the hole  37  formed in the insertion part  5 . The stopper  33 B, accommodated inside the hole  37 , is thus pulled in the direction to become detached from the hole  37  in accordance with the orientation of the hole  37  and the stopper  33 B falls out of the hole  37 . 
     After positioning, a treating step (S 80 ) of performing observation, incision, cell sampling, suturing, or any of other various treatments (medical procedures) is carried out. After performing the treatment, the overtube  1  and the endoscope  2  are removed from the opening SO of the stomach wall. 
     In a suturing step (S 90 ), in removing the endoscope  2  from the opening SO, the large diameter part  33 C a  of the sutures  33   c  is held and pulled with respect to the stopper  33 B of the double T-bars  33 , which had been placed in advance, by a ligating device  69 , inserted through the channel  60  of the endoscope  2  as shown in  FIG. 20 . The opening SO is thereby sutured. Additional double T-bars  33 , etc., are provided to perform further suturing if necessary. In this process, since the insufflation is performed in the process of placing the double T-bars  33  at the stomach wall, suturing by means of additional double T-bars  33  can be performed readily. 
     After suturing, the endoscope  2  is drawn out of the patient, the pressure applied to the abdominal cavity AC is released, and the surgical procedure is ended. 
     With the overtube  1 , since the incising electrode  6  is disposed at the distal end side of the insertion part  5  and across the distal end side of the lumen  3 , when the insertion part  5  is inserted into the stomach ST, the stomach wall can be incised without requiring a special treatment instrument for incision. Because, in this process, tissue is incised just by an amount corresponding to the length of the incising electrode  6  that crosses the lumen  3 , the overtube  1  can be made to pass through with a light force and leakage at the outer periphery of the overtube  1  can be restrained preferably. Also, since the electrode manipulating wires  7 A and  7 B are removable with respect to the electrode manipulating part  8 , the incising electrode  6  can be removed along with the electrode manipulating wires  7 A and  7 B from the insertion part  5 . Thus, in making the endoscope  2  protrude out from the lumen  3 , the incising electrode  6  will not be an obstruction, and upon inserting the endoscope  2  through the lumen  3 , the endoscope  2  can be advanced into the abdominal cavity AC beyond the incised tissue. Furthermore, in making the device (endoscope  2  in the embodiment) that has been inserted through the lumen  3  protrude and advance from the distal end of the overtube  1  after incising tissue and forming the opening, the task of withdrawing the incising electrode  6  from the path of the device, the task of drawing out the overtube  1  once from within the body to remove the incising electrode  6 , etc., can be omitted. Consequently, the surgical procedure time from the forming of the opening in the stomach wall to the introducing of the endoscope  2  into the abdominal cavity AC can be shortened. 
     Also, since the incising electrode  6  is connected to the electrode manipulating wires  7 A and  7 B, which can be manipulated to advance and retract with respect to the lumen  3 , the incising electrode  6  can be advanced and retracted with respect to the lumen  3  without performing a manipulation of advancing and retracting the entirety of the insertion part  5 . That is, by advancing and retracting of the electrode manipulating part  8 , the incising electrode  6  can be advanced and retracted with respect to the stomach wall to perform incision. In this process, because the incision is performed by passing high-frequency electricity through the incising electrode  6 , the incision can be performed more safely with a small force. 
     Also, before incising and forming an opening in a wall of a hollow organ (the stomach wall in the embodiment), the double T-bars  33  can be placed, and in inserting the puncture needles  32 A and  32 B through the stomach wall, puncture can be performed preferably without the stomach wall moving away. Furthermore, the double T-bars  33  can be placed before opening formation (before suturing) to set up a state in which the double T-bars  33  are just constricted in the suturing process, and in suturing the opening after ending the medical procedure inside the abdominal cavity AC, the suturing of the opening can be performed more readily without insufflating the interior of the stomach. The suturing task can thus be performed more readily. 
     Also, because the direction in which the incising electrode  6  crosses the lumen  3  is orthogonal to the direction of joining the puncture needles  32 A and  32 B, the positions of puncturing by the puncture needles  32 A and  32 B can be separated from the incision location, and the double T-bars  33  can be placed at a position separated from the incision location by a distance that is appropriate for binding. 
     Second Embodiment 
     A second embodiment according to this invention shall now be described with reference to the drawings. 
     A point of difference of the second embodiment with respect to the first embodiment is that an overtube  70  according to this embodiment has a first magnet (magnetic body)  71 , disposed on an outer peripheral surface of the insertion part  5  near the proximal end of the bending part  13 , a second magnet (magnetic body)  72 , disposed on an outer peripheral surface at the distal end of the bending part  13 , and a third magnet (magnetic body)  73 , disposed more toward the proximal end side (manipulating handle  21  side) of the insertion part  5  than the first magnet  71 , as shown in  FIG. 21 . In order to restrain the insertion part  5  of the overtube  1  from becoming large in diameter and yet secure the inner diameter of the lumen  3 , the first magnet  71  (and likewise, the second magnet  72  and the third magnet  73 ) is, for example, divided into and disposed as magnet pieces  71 A,  71 B,  71 C, and  71 D at portions besides portions at which the electrode tube  18  and the outer sheaths  38 , inserted through the insertion part  5 , are disposed as shown in  FIG. 22 . 
     Each of these magnets  71 ,  72 , and  73  is formed so that all of the outer peripheral surface is of the same magnetic pole and these magnets are arranged so that the magnetic poles alternate along the insertion part  5 , for example in a manner such that when the first magnet  71  is of the S pole, the second magnet  72  and the third magnet  73  are of the N pole. 
     Actions of this embodiment shall now be described in line with a medical procedure performed via a natural orifice using the overtube  70  as shown by the flow chart of  FIG. 23 . 
     As in the first embodiment, the steps from the inserting step (S 10 ) to the removing step (S 60 ) are carried out in this embodiment as well. 
     An introducing step (S 100 ) is then performed. That is, as shown in  FIG. 19 , the endoscope inserting part  51  of the endoscope  2  is introduced inside the abdominal cavity AC through the opening SO as shown in  FIG. 19 . 
     Then with the distal end part  15  of the overtube  70  being protruded from the opening SO of the stomach ST, a moving magnet  75  is placed on an abdominal wall AW near the opening SO with the magnetic pole that is attracted to the second magnet  72  of the overtube  70  being set at the inner side as shown in  FIGS. 24A and 24B . In this process, the moving magnet  75  and the second magnet  72  are attracted to each other. The moving magnet  75  is then moved along the abdominal wall AW to a position at which a treatment site is located. In this process, the distal end  15  moves while being attracted to the moving magnet  75 . The endoscope inserting part  51  may be advanced with respect to the insertion part of the overtube  70  in advance as shown in  FIG. 24A , and then the moving magnet  75  may be used to advance the distal end part  15  of the overtube  70  along the endoscope inserting part  51  toward the distal end of the endoscope inserting part  51  as shown in  FIG. 24B . Or, the moving magnet  75  may be moved with the endoscope inserting part  51  being accommodated inside the overtube  70  as shown in  FIG. 25A , and then the endoscope inserting part  51  may be moved along with the overtube  70  as shown in  FIG. 25B . 
     In order to secure a bended state of the bending part  13 , a fixing magnet  76  is placed on the abdominal wall AW with the magnetic pole attracted to the first magnet  71  being set at the inner side as shown in  FIG. 26 . Since the fixing magnet  76  and the first magnet  71  are attracted to each other, a bending manipulation is performed by manipulating the bending lever  45  with the insertion part  5  being fixed to and supported on the abdominal wall AW. Here, in order to change the direction of the distal end part  15  with the bended state of the inserted part  5  being maintained, supporting magnets  77 A and  77 B are placed on the abdominal wall AW. That is, the supporting magnet  77 A and the first magnet  71  are made to be attracted to each other, and the supporting magnet  77 B and the third magnet  73  are made to be attracted to each other. When the mutual attraction state is realized, for example, the first magnet  71  side is rotatingly moved about the third magnet  73  side with the third magnet  73  side being fixed to change the direction of the distal end part  15  as shown in  FIG. 27 . 
     After then carrying out the treating step (S 80 ), the endoscope  2  is returned into the stomach ST from the opening SO of the stomach wall and taken out from the mouth M of the patient PT, and then the suturing step (S 90 ) is performed. The opening SO of the stomach wall is then sutured. 
     After suturing, the endoscope  2  is drawn out of the patient, the pressure applied to the abdominal cavity AC is released, and the surgical procedure is ended. 
     With the overtube  70 , the same actions and effects as those of the first embodiment can be exhibited. In particular, since the first magnet  71 , the second magnet  72 , and the third magnet  73  are disposed at the outer portions of the insertion part  5 , these can be attracted to the moving magnet  75 , the fixing magnet  76 , and the supporting magnets  77 A and  77 B to thereby support the insertion part  5  on the abdominal wall AW. The endoscope  2  that has been inserted into the overtube  70  can thus be restrained preferably from moving away during treatment. Also, by movement of the moving magnet  75 , the distal end direction of the endoscope  2  that has been inserted into the overtube  70  can be moved readily and the direction of endoscope  2  can be controlled readily by the magnets. Also, movement, fixing, and supporting of the overtube  70  can be performed from outside the body by using the moving magnet  75 , the fixing magnet  76 , and the supporting magnets  77 A and  77 B to further facilitate orientation of the overtube  70 . 
     The scope of the art of this invention is not restricted to the embodiments described above, and various changes can be added within a range that does not fall outside the spirit of this invention. 
     For example, though in each of the above-described embodiments, a flexible endoscope is used as the observation device, this invention is not restricted thereto and, for example, a so-called capsule endoscope may be placed inside the body, and while observing the interior of the body using the endoscope, an insertion part of a treatment device that does not have an observation device may be inserted through the overtube to perform the desired surgical procedure. 
     Though in the first embodiment, the incision electrode  6  is set to a length such that it is accommodated inside the lumen  3  in a bended state as shown in  FIG. 4 , this invention is not restricted thereto, and the incision electrode  6  may be set to a length such that it is accommodated inside the lumen  3  without being bended. The length of the incision electrode (length of the portion that crosses the lumen) may be set suitably according to the outer diameter of the overtube itself or according to the outer diameter of a device that is inserted through the lumen. This prevents the forming of an opening that is greater than necessary. Thus when a device is introduced into the abdominal cavity through an opening in a hollow organ that has been formed using the incision electrode, the gap formed between the device and the opening can be held at the minimum and sealing of the inner side and the abdominal cavity side of the hollow organ can be secured at a level by which the pressure applied to the abdominal cavity AC can be maintained. 
     An overtube  82 , having four puncture needles  81 A,  81 B,  81 C, and  81 D disposed at a distal end part  80 , may be arranged as shown in  FIG. 28 . In this case, the puncture needles  81 A and  81 B and the puncture needles  81 C and  81 D are positioned at respectively symmetrical positions with respect to a line joining the first inner groove  16  and the second inner groove  17  of the distal end part  80 . By housing the anchors  33 A of the double T-bars  33  in the respective puncture needles, two suturing locations can be secured with respect to the incision direction. 
     Likewise, an overtube  86 , having six puncture needles  85 A,  85 B,  85 C,  85 D,  85 E, and  85 F disposed at a distal end part  83 , may be arranged as shown in  FIG. 29 . In this case, the puncture needles  85 A and  85 B, the puncture needles  85 C and  85 D, and the puncture needles  85 E and  85 F are positioned at respectively symmetrical positions with respect to a line joining the first inner groove  16  and the second inner groove  17  of the distal end part  83 . By housing the anchors  33 A of the double T-bars  33  in the respective puncture needles, three suturing locations can be secured with respect to the incision direction. 
     As shown in  FIGS. 28 and 29 , by providing four or six puncturing needles at the distal end part and thereby securing a plurality of suturing locations with respect to the incision location, a more reliable suturing can be carried out. 
     As shown in  FIGS. 30 and 31 , it is acceptable to provide an overtube  96  in which the opening  95 A of a lumen for needle  95  is provided at the base end of a first outer groove  91  and a second outer groove  92  which are provided in the distal end part  90 , the lumen for needle  95  extending from the base end side of the distal end part  90  and permitting retraction and projection of the puncture needles  93 A,  93 B. The inner diameter of the lumen for needle  95  is formed to be smaller than the width of the first outer groove  91  and the second outer groove  92 , and to have a stepped portion  97 . Furthermore, a first slit  98 , into which the suture  33 C of the double T-bar  33  can be inserted and passed through is provided extending in the longitudinal direction from the distal end of the puncture needles  93 A and  93 B, and a second slit  99 , which is in communication with the outside surface of the distal end part  90  and into which the suture  33 C can be inserted and passed through, is provided extending in the longitudinal direction from the opening  95 A of the lumen for needle  95 . 
     When housing the anchor  33 A for the double T-bar  33  in the puncture needles  93 A, 93 B, the anchor  33 A is housed inside the puncture needles  93 A,  93 B, and stopper  33 B is housed in the hole  37  by taking the suture  33 C around the outer peripheral surface of the distal end part  90 . Here, one end of the suture  33 C is inserted into the anchor  33 A, and is made to extend out so as to fold over from the slit  33 A a , with the stopper  33 B being disposed at the other end. Since the suture  33 C is formed, for example, of a resin such as nylon which is more highly elastic than thread or silk, the anchor  33 A and the suture  33 C are connected such that, in the natural state where there is no external force being applied, the suture  33 C does not extend out in a perpendicular direction from the slit  33 A a  of the anchor  33 A, but rather forms an acute angle with respect to one end of the anchor  33 A and forms an obtuse angle with respect to the other end of the anchor  33 A. For this reason, when housing the anchor  33 A in the puncture needles  93 A,  93 B, the direction of the anchor  33 A is disposed so that the large diameter part  33 C a  is directed toward the distal end of the puncture needles  93 A,  93 B, as shown in  FIGS. 32 and 33 . In this case, the suture  33 C extends in the direction forming an acute angle with the base end side of the puncture needles  93 A,  93 B. Note that the anchor and the suture may be formed in a unitary manner of an identical material, such as nylon, for example. This suture  33 C extends still further toward the outer surface of the distal end part  90  via the first slit  98  and the second slit  99 . In this state, the puncture needles  93 A, 93 B are retracted back toward the base end side of the overtube  96 , with the distal ends of the puncture needles  93 A,  93 B housed so as to recede from the opening  95 A of the lumen for needle  95 . 
     Theoretically, in the case where there is no first slit  98 , then suture  33 C is exposed from the opening  95 A of the lumen for needle  95 , and extends out toward the outer surface of the distal end part  90 , and the suture  33 C is folded over inside the lumen for needle  95  at an acute angle. In this case, an undesirable bending tendency in the suture  33 C may arise depending on the suture material used. When this bending tendency arises in the penetrating direction of the puncture needles  93 A,  93 B, then, as shown in  FIG. 34 , when the portion of the suture material in which bending has occurred comes into contact with the tissue, resistance is encountered. As a result, the puncturing operation does not go smoothly. Furthermore, theoretically, when the opening  95 A of the lumen for needle  95  is on a side surface different from that of the hole  37 , i.e., when the opening  95 A is formed on the inside surface, then the suture  33 C is disposed so as to transect the distal end surface  90   a  of the distal end part  90 . Accordingly, when carrying out the placing step, the suture  33 C becomes interposed between the distal end surface  90   a  and the tissue, and the suture  33 C is pulled in the puncturing direction of the puncture needles  93 A,  93 B accompanying the action of puncturing the tissue with the puncture needles  93 A,  93 B. When the pulling force acts in a direction to move the tissue away from the distal end part  90 , and when the pulling force is exceed a force that brings the tissue near and into contact with the distal end surface  90   a,  then the state in which the tissue is drawn to and held in contact with the distal end part  90  is released. In this case, it becomes difficult for the puncturing action to be carried out smoothly. 
     In contrast, by means of the present overtube  96 , the opening  95 A from which puncture needles  93 A,  93 B project out is formed to the same side as the outside of the distal end part  90 . Thus, even if the tissue is drawn toward the distal end surface  90   a,  the suture  33 C is not disposed between the distal end surface  90   a  and the tissue. Accordingly, the puncturing action can be carried out smoothly. Furthermore, since a first slit  98  is provided, it is possible to reduce the occurrence of undesirable bending in the suture  33 C. Accordingly, the puncture operation can be carried out with greater certainty. In addition, by disposing the anchor  33 A in puncture needles  93 A,  93 B as described above, the angle formed by the suture  33 C and the tissue when puncturing the tissue is small, i.e., the angle formed between the direction of extension of the suture  33 C and the lumen for needle  95  becomes closer to parallel. Accordingly, when puncturing, it is possible to limit the resistance of the suture  33 C with respect to the tissue, and to carry out the puncturing operation with greater certainty. 
     In addition, as shown in  FIGS. 35 and 36 , it is also acceptable to provide in place of a first outer groove  91  and a second outer groove  92 , an overtube  101  in which a lumen for needle  95  is provided opening directly on the distal end surface  100   a  of the distal end part  100 . This arrangement offers actions and effects equivalent to those of the overtube  101  described above.