Patent Publication Number: US-2015080930-A1

Title: Puncture apparatus and puncturing method

Description:
CROSS-REFERENCES TO RELATED APPLICATIONS 
     This application claims priority to Japanese Application No. 2013-192439 filed on Sep. 17, 2013, the entire content of which is incorporated herein by reference. 
     TECHNICAL FIELD 
     The present disclosure relates to a puncture apparatus and a puncturing method. 
     BACKGROUND DISCUSSION 
     In a patient suffering from urinary incontinence, for example, stress urinary incontinence, urine leakage (involuntary urination) occurs due to an abnormal pressure exerted during a normal exercise or by laughing, coughing, sneezing or the like. This can be attributable, for example, to loosening of a pelvic floor muscle, which is a muscle supporting a urethra, caused by childbirth or the like. 
     For treatment of urinary incontinence, surgical therapy is effective. For example, a tape-shaped implant called “sling” is placed indwelling in the body to support the urethra by the sling (for example, U.S. Pat. No. 6,911,003). In order to put a sling indwelling in the body, an operator can incise a vagina with a surgical knife, dissects a biological tissue (living body tissue) between the urethra and the vagina, and provides communication between the exfoliated biological tissue site and an exterior through an obturator foramen by using a puncture needle or the like which is curved in an arcuate shape (this operation will hereinafter be referred to as “puncturing operation”). Then, in such a state, the sling is placed indwelling in the body. 
     In the case where the puncturing operation is carried out using a puncture needle having a comparatively large radius of curvature there can be issues. For example, although a puncture to a good depth from a body surface can be achieved by this operation, there can be a risk of erroneously puncturing a blood vessel such as common iliac artery and veins, femoral artery and veins, obturator artery and veins, etc. or nerve such as obturator nerve. For example, where a puncturing operation using a puncture needle with a comparatively small radius of curvature is applied to a comparatively large patient where a distance from a body surface to a tissue between a urethral lumen and a vaginal lumen (vaginal cavity) is long, the puncture needle may fail to satisfactorily reach a target site, depending on the length of the puncture needle. 
     SUMMARY 
     In accordance with an exemplary embodiment, a puncture apparatus and a puncturing method are disclosed by which a biological tissue can be punctured relatively accurately and satisfactorily. 
     In accordance with an exemplary embodiment, a puncture apparatus is disclosed, which can include a puncture needle which punctures a biological tissue, the puncture needle being elongated and able to be curved; and a curvature-changing unit which changes curvature of the puncture needle in a process of puncturing the biological tissue by the puncture needle. 
     In accordance with an exemplary embodiment, the curvature-changing unit can be configured to cause the puncture needle to sequentially perform a first puncture and a second puncture greater than the first puncture in the curvature of the puncture needle. 
     In accordance with an exemplary embodiment, the puncture apparatus is for use in forming the biological tissue with a puncture hole in which an implant is to be placed indwelling between a urethral lumen and a vaginal lumen, prior to the placement; and the first puncture is performed during when a needle tip of the puncture needle is moved from a living body surface to a point of immediately before reaching an obturator foramen on one side, and the second puncture is performed during when the needle tip of the puncture needle is moved from the point of immediately before reaching the obturator foramen on the one side to cross a region between the urethral lumen and the vaginal lumen and is moved past an obturator foramen on other side. 
     In accordance with an exemplary embodiment, a restriction unit is disclosed, which performs the first puncture; and a curved portion which performs the second puncture, the curved portion so configured as to be insertable in the restriction unit, wherein the restriction unit restricts curvature of the curved portion. 
     In accordance with an exemplary embodiment, the curved portion is curved in an arcuate shape in a natural state. 
     In accordance with an exemplary embodiment, an operating unit is disclosed which deforms the curved portion into an arcuate state. 
     In accordance with an exemplary embodiment, the curved portion is so configured that its rotation about an axis along a direction of puncture is restricted by insertion of the curved portion in the restriction unit. 
     In accordance with an exemplary embodiment, a method of puncturing a biological tissue to form the biological tissue with a bow-like puncture hole is disclosed, the method including: puncturing in such a manner that curvature of the puncture hole varies along a longitudinal direction of the puncture hole, in a process of puncturing the biological tissue. 
     In accordance with an exemplary embodiment, in the process of puncturing a biological tissue to form a puncture hole, the curvature of the puncture needle can be appropriately changed according to the depth of puncture. In addition, attendant on the variation in the curvature of the puncture needle, the puncture hole thus formed is also varied in curvature along the longitudinal direction thereof. Thus, erroneous punctures of common iliac artery or issues in which the puncture needle cannot reach a target site can be prevented. Consequently, a biological tissue can be puncture relatively accurately and satisfactorily. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a perspective view showing a first exemplary embodiment of a puncture apparatus according to the present disclosure. 
         FIG. 2  is a side view of the puncture apparatus shown in  FIG. 1 . 
         FIG. 3  is a plan view showing a fixing portion of a frame possessed by the puncture apparatus shown in  FIG. 1 . 
         FIG. 4  is a side view of an insertion instrument possessed by the puncture apparatus shown in  FIG. 1 . 
         FIGS. 5A and 5B  illustrate a positional relationship between a puncture member and obturator foramens (pelvis), wherein  FIG. 5A  is a side view and  FIG. 5B  is a front view. 
         FIG. 6  is a partial magnified view of a vaginal insertion member possessed by the insertion instrument shown in  FIG. 4 . 
         FIG. 7A  is a sectional view showing an example of a shape of a vaginal wall, and  FIG. 7B  is a sectional view showing a state in which a vaginal insertion portion has been inserted in an inside of the vagina shown in  FIG. 7A . 
         FIGS. 8A and 8B  illustrate a puncture member possessed by the puncture apparatus shown in  FIG. 1 , wherein  FIG. 8A  is a perspective view and  FIG. 8B  is a sectional view. 
         FIGS. 9A and 9B  are views illustrating an operation procedure of the puncture apparatus shown in  FIG. 1 . 
         FIG. 10  is a view illustrating the operation procedure of the puncture apparatus shown in  FIG. 1 . 
         FIG. 11  is a side view illustrating a relationship between the puncture apparatus and the pelvis in the state shown in  FIG. 10 . 
         FIG. 12  is a view (as viewed from a patient&#39;s leg side) illustrating the operation procedure of the puncture apparatus shown in  FIG. 1 . 
         FIG. 13  is a view (as viewed from the patient&#39;s leg side) illustrating the operation procedure of the puncture apparatus shown in  FIG. 1 . 
         FIG. 14  is a view (as viewed from the patient&#39;s leg side) illustrating the operation procedure of the puncture apparatus shown in  FIG. 1 . 
         FIG. 15  is a view (as viewed from the patient&#39;s leg side) illustrating the operation procedure of the puncture apparatus shown in  FIG. 1 . 
         FIG. 16  is a view (as viewed from the patient&#39;s leg side) illustrating the operation procedure of the puncture apparatus shown in  FIG. 1 . 
         FIG. 17  is a view (as viewed from the patient&#39;s leg side) illustrating the operation procedure of the puncture apparatus shown in  FIG. 1 . 
         FIG. 18  is a sectional view taken along line  18 - 18  in  FIG. 14 . 
         FIG. 19  is a sectional view taken along line  19 - 19  in  FIG. 16 . 
         FIG. 20  is a sectional view taken along line  20 - 20  in  FIG. 17 . 
         FIG. 21  is a view illustrating an operation procedure of the puncture apparatus in accordance with a second exemplary embodiment of the present disclosure. 
         FIG. 22  is a view illustrating the operation procedure of the puncture apparatus according to the present disclosure. 
         FIG. 23  is a side view showing a third exemplary embodiment of the puncture apparatus according to the present disclosure. 
         FIG. 24  is a side view showing a fourth exemplary embodiment of the puncture apparatus according to the present disclosure. 
         FIG. 25  is a perspective view showing a fifth exemplary embodiment of the puncture apparatus according to the present disclosure. 
         FIG. 26  is a plan view showing a puncture member possessed by the puncture apparatus shown in  FIG. 25 . 
         FIG. 27  is a perspective view showing the puncture member possessed by the puncture apparatus shown in  FIG. 25 . 
         FIG. 28  is a sectional view of the puncture member shown in  FIG. 27 . 
         FIGS. 29A to 29C  illustrate a state-maintaining mechanism possessed by the puncture member shown in  FIG. 27 , wherein  FIG. 29A  is a top plan view and  FIGS. 29B and 29C  are sectional views. 
         FIGS. 30A to 30C  are partial magnified views showing the state-maintaining mechanism possessed by the puncture member shown in  FIG. 26 , wherein  FIGS. 30A and 30B  are plan views showing modifications, respectively, and  FIG. 30C  is a plan view showing this exemplary embodiment. 
         FIG. 31  is a view (as viewed from the patient&#39;s leg side) illustrating an operation procedure of the puncture apparatus shown in  FIG. 25 . 
         FIG. 32  is a view (as viewed from the patient&#39;s leg side) illustrating the operation procedure of the puncture apparatus shown in  FIG. 25 . 
         FIG. 33  is a view (as viewed from the patient&#39;s leg side) illustrating the operation procedure of the puncture apparatus shown in  FIG. 25 . 
         FIG. 34  is a view (as viewed from the patient&#39;s leg side) illustrating the operation procedure of the puncture apparatus shown in  FIG. 25 . 
         FIG. 35  is a view (as viewed from the patient&#39;s leg side) illustrating the operation procedure of the puncture apparatus shown in  FIG. 25 . 
         FIG. 36  is a view (as viewed from the patient&#39;s leg side) illustrating the operation procedure of the puncture apparatus shown in  FIG. 25 . 
         FIGS. 37A to 37D  illustrate operating states of a support unit possessed by the puncture apparatus shown in  FIG. 25 . 
         FIGS. 38A and 38B  illustrate a support unit possessed by the puncture apparatus in accordance with a sixth exemplary embodiment of the present disclosure, wherein  FIG. 38A  is a plan view and  FIG. 38B  is a cross-sectional view. 
         FIG. 39  is a view (as viewed from the patient&#39;s leg side) illustrating an operation procedure of the puncture apparatus in accordance with a seventh exemplary embodiment of the present disclosure. 
         FIG. 40  is a view (as viewed from the patient&#39;s leg side) illustrating the operation procedure of the puncture apparatus according to the present disclosure. 
         FIG. 41  is a view (as viewed from the patient&#39;s leg side) illustrating the operation procedure of the puncture apparatus according to the present disclosure. 
         FIG. 42  is a view (as viewed from the patient&#39;s leg side) illustrating the operation procedure of the puncture apparatus according to the present disclosure. 
         FIG. 43  is a view (as viewed from the patient&#39;s leg side) illustrating the operation procedure of the puncture apparatus according to the present disclosure. 
         FIG. 44  is a view (as viewed from the patient&#39;s leg side) illustrating the operation procedure of the puncture apparatus according to the present disclosure. 
         FIG. 45  is a view (as viewed from the patient&#39;s leg side) illustrating the operation procedure of the puncture apparatus according to the present disclosure. 
         FIG. 46  is a view (as viewed from the patient&#39;s leg side) illustrating the operation procedure of the puncture apparatus according to the present disclosure. 
         FIGS. 47A to 47E  illustrate operating states of a support unit possessed by the puncture apparatus according to the present disclosure. 
         FIGS. 48A and 48B  are sectional views showing an eighth exemplary embodiment of the puncture apparatus according to the present disclosure. 
         FIG. 49  is a perspective view showing a puncture member possessed by the puncture apparatus in accordance with a ninth exemplary embodiment of the present disclosure. 
         FIG. 50  is a sectional view showing a modification of the puncture member shown in  FIG. 49 . 
     
    
    
     DETAILED DESCRIPTION 
     A puncture apparatus and a puncturing method according to the present disclosure will be described in detail below, referring to exemplary embodiments illustrated in the accompanying drawings. 
       FIGS. 1-20  illustrate a first exemplary embodiment of a puncture apparatus according to the present disclosure. In the following disclosure, for convenience of description, a left side in  FIG. 2  will be referred to as “distal (side),” a right side as “proximal (side),” an upper side as “upper (side),” and a lower side as “lower (side).” In addition,  FIG. 2  shows the puncture apparatus in a state of being yet to be used, which state will hereinafter be referred to also as “initial state,” for convenience of description. Further, a state wherein the puncture apparatus (insertion instrument) shown in  FIG. 2  is mounted on a patient will be referred to also as “mounted state.” 
     In accordance with an exemplary embodiment, a puncture apparatus  1 , which can be used for treatment of female urinary incontinence is disclosed, for example, to be used in a process in which a biological tissue-supporting implant for treatment of urinary incontinence is implanted into a living body. 
     As shown in  FIGS. 1 and 13 , the puncture apparatus  1  can include a frame (support unit)  2 , a puncture member  3 A, a urethral insertion member  4 , and a vaginal insertion member  5 . The puncture member  3 A, the urethral insertion member  4 , and the vaginal insertion member  5  are supported on the frame  2 . In the puncture apparatus  1 , besides, the urethral insertion member  4  and the vaginal insertion member  5  constitute an insertion instrument  6 . 
     As shown in  FIGS. 1 and 2 , the frame  2  can include a grasping portion  21  to be grasped in the mounted state, a guide portion (holding portion)  22  guiding the puncture member  3 A, an interlock portion  23  interlocking the grasping portion  21  and the guide portion  22  to each other, and a fixing portion  24  to which the insertion instrument  6  is fixed. 
     The grasping portion  21  is located on a proximal end in the puncture apparatus  1 , and extends in a direction substantially orthogonal to an axis J1. The “axis J1” refers to an axis, which serves as a center (axis) of turn when the puncture member  3 A is turned. 
     The guide portion  22  is located on a distal end in the puncture apparatus  1 , and is disposed opposite to the grasping portion  21 . The guide portion  22  can be arch-shaped, and can be provided with an engaging portion  224  at an outer circumferential portion of a lower end of the guide portion  22 . The engaging portion  224  can be composed essentially of a projection which projects outward. 
     The interlock portion  23  can interlock the grasping portion  21  and the guide portion  22  to each other. In addition, the interlock portion  23  can be in a form of a bar extending substantially parallel to the axis J1. The interlock portion  23  can also function as a grasping portion, like the grasping portion  21 , to allow an operator to use the puncture apparatus  1  by grasping the interlock portion  23 . 
     The fixing portion  24  is disposed opposite to the interlock portion  23 , with the axis J1 interposed therebetween. As shown in  FIG. 3 , the fixing portion  24  is provided with a recess  243  in which to fit a support part  60  (described later) of the insertion instrument  6 , and a male screw  244 . With the support part  60  fitted in the recess  243  and with the male screw  244  fastened into a female screw (not shown) in the support part  60 , the insertion instrument  6  can be fixed to the fixing portion  24 . 
     The puncture member  3 A is a member puncturing a living body (biological tissue). As shown in  FIGS. 13 to 16 , the puncture member  3 A can include a puncture needle  11 , a sheath (medical tube)  30 , a connection member  12  and a restriction member  13 , which constitute an assembly. 
     The puncture needle  11  is configured by use of an elongated wire material, and can be elastic, which help permits the puncture needle  11  to be elastically deformed into a curved shape. The puncture needle  11  can be rectilinear in shape in a natural state with no external force exerted on the puncture needle  11 . 
     The puncture needle  11  may be formed of a metallic material. The metallic material is not specifically restricted, and examples of the metallic material can include superelastic alloys such as Ni—Ti alloys, Ni—Al alloys and Cu—Zn alloys. 
     A distal portion of the puncture needle  11  can be in a tapered shape, with its outside diameter decreasing gradually along the distal direction, which can result in that the puncture needle  11  is formed at its distal end with a sharp needle tip  111 . This needle tip  111  is a part, which mainly bears puncturing of a living body. 
     In accordance with an exemplary embodiment, an outer circumferential portion of the puncture needle  11  has preferably been subjected to a friction-lowering treatment by application of lubricant, for example. Such a treatment permits an operation of inserting the puncture needle  11  into the sheath  30  to be carried out relatively easily. 
     The sheath  30  can include a tube-shaped main body  31 , and a mounting portion  37  provided at a proximal portion of the main body  31 . 
     The main body  31  is configured by use of an elongate tube, which has an opening at a distal end and a proximal end of the elongate tube. In accordance with an exemplary embodiment, the main body  31  can have an internal space in which the puncture needle  11  and an implant  9  can be inserted. As shown in  FIG. 14 , the main body  31 , with the puncture needle  11  inserted therein (inserted state), can pierce (puncture) a living body together with the puncture needle  11 . An edge portion of a distal opening portion of the main body  31  is preferably in a tapered shape, with its outside diameter decreasing gradually along the distal direction, which helps ensure that in the inserted state, the edge portion of the main body  31  and the distal portion of the puncture needle  11  form a continuous tapered surface, so that puncturing of a biological tissue is facilitated. The overall lengths of the puncture needle  11  and the implant  9  can be sufficiently greater than the overall length of the main body  31 . 
     As shown in  FIG. 8A , the main body  31  has a curved portion  314  ranging at least to a predetermined distance from the distal end of the main body  31 . The curved portion  314  can be a portion which has been so shaped that it will be in an arc-shaped (arcuate) curved form in a natural state with no external force exerted on the curved portion  314 . 
     In accordance with an exemplary embodiment, a center angle of the curved portion  314  is not limited, and is set, as necessary, according to various conditions. For example, as will be described later, the center angle can be set that the curved portion  314  can enter a patient body via an inguinal region on one side of the patient together with the puncture needle  11  and can be moved past a region between a urethra  1300  and a vagina  1400 , to reach a vicinity of an inguinal region on the other side. For example, the center angle can be in the range of 150 to 270 degrees, more preferably 170 to 250 degrees, and further preferably 190 to 230 degrees. 
     In addition, the main body  31  can be configured that at least its curved portion  314  is elastic. As shown in  FIG. 13 , the curved portion  314  is restricted into a rectilinear shape by the restriction member  13 . 
     As shown in  FIG. 8B , the main body  31  is flat-shaped in cross section. For example, the cross-sectional shape of the curved portion  314  at a central portion S4 in the longitudinal direction of the main body  31  is a flat shape which includes a minor axis J31 and a major axis J32. As will be described later, an implant main body  91  is disposed inside the main body  31 , in place of the puncture needle  11 . For example, with the main body  31  flat-shaped, a posture of the implant main body  91  inside the main body  31  can be controlled. 
     In accordance with an exemplary embodiment, a width (a length in a direction of the major axis J32) of an internal space of the main body  31  can be designed to be approximately equal to a width of a main body portion  911  (described later) of the implant main body  91  (see  FIG. 19 ), which can help ensure that even when the implant main body  91  is moved, a frictional resistance between the implant main body  91  and the internal space of the main body  31  is lowered, and no relatively unnecessary force can be applied to the implant main body  91 , so that the main body portion  911  can be disposed in a sufficiently expanded (spread) state in the inside of the main body  31 . The width (the length in the direction of the major axis J32) of the internal space of the main body  31  may be shorter than the width of the main body portion  911 , which can help ensure that the width of the main body  31  is set smaller, so that a less invasive puncture member  3 A can be realized. 
     In accordance with an exemplary embodiment, the flat shape of the main body  31  is not specifically restricted. Examples of the flat shape applicable here include ellipses, sectionally convexed lens-like shapes, rounded-cornered rhombuses, rounded-cornered rectangles (flat shapes), and spindle-like shapes enlarged (enlarged in diameter) at a central portion as compared with both end portions of the main body  31 . 
     Hereinafter, for convenience of description, as shown in  FIG. 8B , an end portion located on an inner side (one end portion) in the direction of the major axis J32 will be referred to also as “inner circumferential portion A1,” an end portion located on an outer side (other end portion) will be referred to also as “outer circumferential portion A2,” a surface oriented upward will be referred to also as “front surface A3,” and a surface oriented downward will be referred to also as “back surface A4.” 
     When a plane containing both the center of the arc of the central portion S4 and the center of the cross-sectional shape relative to the longitudinal direction of the main body  31  (a plane containing the center axis of the main body  31 ) is referred to as plane f9 and an angle formed between the plane f9 and the minor axis J31 at the central portion S4 is referred to as inclination angle θ1, the inclination angle θ1 is preferably an acute angle. With the inclination angle θ1 set to be an acute angle, the implant  9  (described later) can be disposed substantially in parallel to the urethra (urethral lumen)  1300 , whereby the urethra  1300  can be effectively supported. 
     The inclination angle θ1 is not limited, insofar as it is an acute angle. In accordance with an exemplary embodiment, the inclination angle θ1 is preferably about 20 to 60 degrees, more preferably about 30 to 45 degrees, and further preferably about 35 to 40 degrees, which can help ensure that the above-mentioned effect is further enhanced. 
     In accordance with an exemplary embodiment, it can be preferable for the inclination angle θ1 to satisfy the above-mentioned numerical range throughout a whole region in an extending direction of the curved portion  314 . However, the above-mentioned effect can be displayed if only the inclination angle θ1 satisfies the above-mentioned numerical range at least in the central portion S4 in the extending direction of the curved portion  314 . In accordance with an exemplary embodiment, the above-mentioned “central portion S4” refers to a region that includes a part located between the urethra  1300  and the vagina (vaginal lumen)  1400 , at least, in a state wherein the puncture member  3 A is puncturing a living body (a state wherein the main body  31  is disposed in a living body). 
     The configuration of the main body  31  can also be expressed as shown in  FIG. 8B , where the main body  31  is so formed that the major axis J32 is inclined against a center axis J5 of the arc and that the center axis J5 of the arc and an extension line J32′ of the major axis J32 have an intersection P. For example, an angle θ5 formed between the center axis J5 and the extension line J32′ can be equal to the inclination angle θ1. For example, as shown in  FIG. 8B , the main body  31  can have the inner circumferential portion A1 located at an inner circumferential edge (in plan view as viewed from the direction of the center axis J5 of the main body  31 ) and can have a minimum radius of curvature, r1, and also has the outer circumferential portion A2 located at an outer circumferential edge (in the plan view) and can have a maximum radius of curvature, r2, and that the inner circumferential portion A1 and the outer circumferential portion A2 are located to be spaced (deviated) from each other along the direction of the center axis J5. 
     As disclosed above, the main body  31  is flat-shaped and is insusceptible to collapse in the longitudinal direction of the main body  31 , so that the spacing between the inner circumferential portion A1 and the outer circumferential portion A2 will hardly be varied. In addition, the inner circumferential portion A1 and the outer circumferential portion A2 can be greater in curvature and are less susceptible to deformation, as compared with the front surface A3 and the back surface A4. 
     The mounting portion  37  can be provided at an outer circumferential portion of the proximal end (upper end portion) of the main body  31 . The mounting portion  37  is formed along the circumferential direction of the main body  31  so as to project in a ring shape, and can be fitted to a proximal portion of the connection member  12  from the outer circumference side of the latter (see  FIGS. 14 to 16 ), which can help ensure that the sheath  30  is detachably mounted to the connection member  12  through the mounting portion  37 . 
     The sheath  30  can be formed of a material that is elastic and that maintains the shape and the internal space of the sheath  30  in a state wherein the sheath  30  is inserted in a body. Examples of the material applicable here include various resin materials such as polyethylene, polyimides, polyamides, polyester elastomers, and polypropylene. 
     The sheath  30  can be light-transmitting so that the inside of the sheath  30  is externally visible, which can help ensure, for example, that the conditions of the puncture needle  11  or the implant  9  inserted in the sheath  30  can be visually checked. 
     In addition, an outer circumferential portion of the sheath  30  has preferably been subjected to a friction-lowering treatment by application of lubricant, for example, which permits an operation of inserting the sheath  30  into the connection member  12  and the restriction member  13  to be carried out easily. 
     As shown in  FIG. 13 , the connection member  12  can be composed essentially of a tubular body which is higher than the sheath  30  in rigidity. The tubular body has a rectilinear center axis. In addition, an inside diameter of the connection member  12  can be slightly greater than the outside diameter of the main body  31  of the sheath  30 , which can help ensure that as shown in  FIG. 13 , when the curved portion  314  of the sheath  30  is inserted in the connection member  12 , the curved portion  314  is restricted into a rectilinear shape by the connection member  12 , so that the curved portion  314  can be easily introduced as it is into the restriction member  13 . 
     In accordance with an exemplary embodiment, the connection member  12  can have at its distal end portion (lower end portion) a diametrically enlarged portion  121  enlarged in inside diameter. The diametrically enlarged portion  121  can be fitted over a proximal portion of the restriction member  13  from an outer circumference side of the latter (see  FIGS. 13 to 16 ), which can help ensure that the connection member  12  is detachably connected to the restriction member  13  through the diametrically enlarged portion  121 . 
     An inner circumferential portion of the diametrically enlarged portion  121  can be formed with a groove  122  along its circumferential direction. In this groove  122  is inserted a projection  133  of the restriction member  13 , in a state wherein the connection member  12  is connected to the restriction member  13 , which can help ensure that the diametrically enlarged portion  121  and the restriction member  13  engage with each other, and, by this engagement as well as the above-mentioned fitting, a connected state of the connection member  12  and the restriction member  13  is maintained assuredly. 
     The material constituting the connection member  12  is not specifically restricted. Examples of the material applicable here include not only the same materials as those for the sheath  30  but also various metallic materials such as stainless steels, aluminum, aluminum alloys, titanium, and titanium alloys. 
     As shown in  FIG. 12 , the restriction member  13  is used in a state of being set indwelling at a body surface H (living body surface) by puncturing the body surface H, prior to puncturing by the puncture needle  11 . Like the connection member  12 , the restriction member  13  is composed essentially of a tubular body which is higher than the sheath  30  in rigidity. The tubular body has a rectilinear center axis. The restriction member  13  has a sharp puncture portion  131  at a distal end of the restriction member  13 . The puncture portion  131  can make it possible to easily and assuredly puncture the body surface H toward one of left and right obturator foramens  1101  and  1102  (in this exemplary embodiment, the obturator foramen  1101 ). In accordance with an exemplary embodiment, the overall length of the restriction member  13  can be preferably equal to or greater than the overall length of the connection member  12 . 
     In accordance with an exemplary embodiment, an inside diameter of the restriction member  13  can be slightly greater than the outside diameter of the main body  31  of the sheath  30 , like the inside diameter of the connection member  12 , which can help ensure that as shown in  FIG. 13 , the curved portion  314  is restricted into a rectilinear shape by the connection member  12  and, successively, restricted into a rectilinear shape (straightened) by the restriction member  13 . In accordance with an exemplary embodiment, at its portion protruding from the distal opening of the restriction member  13 , the curved portion  314  is released from the restriction by the restriction member  13 , to return into a curved state (see  FIGS. 14 to 16 ). 
     In accordance with an exemplary embodiment, the restriction member  13  can be provided with a flange portion  132  at an outer circumferential part of an intermediate portion in the longitudinal direction of restriction portion  132 . The flange portion  132  is composed essentially of a diametrically enlarged portion where the outside diameter of the restriction member  13  is enlarged. As shown in  FIG. 12 , the flange portion  132  abuts on the body surface H when the body surface H is punctured by the restriction member  13 , which helps restrict a depth of puncturing of the body surface H by the restriction member  13 . In addition, in the puncture state wherein the body surface H is punctured by the restriction member  13 , the flange portion  132  can engage with the engaging portion  224  of the guide portion  22  of the frame  2 , and can be pressed against the body surface H, which can help prevent the restriction member  13  from being unwillingly pulled out of the body surface H. Accordingly, the puncture state, or indwelling state, can be reliably maintained. 
     In addition, at the outer circumferential portion of the proximal end of the restriction member  13 , the projection  133  is projectingly formed along the circumferential direction. As disclosed above, the projection  133  can contribute to assured maintaining of the connected state of the connection member  12  and the restriction member  13 , through the insertion of the projection  133  into the groove  122  formed in the diametrically enlarged portion  121  of the connection member  12 . 
     The material constituting the restriction member  13  is not restricted; for example, the same material as that constituting the connection member  12  can be used. 
     The restriction member  13  has the puncture portion  131  in the present exemplary embodiment, this is not restrictive, and the restriction member  13  may be one that does not have the puncture portion  131 . 
     In the puncture member  3 A, a curvature-changing unit  14  is composed essentially of the sheath  30 , the connection member  12  and the restriction member  13 . The curvature-changing unit  14  is a mechanism changing a curvature of the puncture needle  11  in the process of puncturing a living body by the puncture needle  11 . Then, a plurality of kinds of puncture can be obtained according to the curvature. In this exemplary embodiment, a first puncture with substantially zero curvature and a second puncture with a curvature greater than the curvature in the first puncture can be obtained. 
     In treatment of female urinary incontinence, the first puncture is performed during when the needle tip  111  of the puncture needle  11  is moved from the body surface H to a point of immediately before reaching the obturator foramen  1101  (see  FIGS. 12 and 13 ). In this first puncture, the puncture needle  11  is inserted and passed in the sheath  30  to have its needle tip  111  protruding from the sheath  30 , and, in this state, the puncture needle  11  passes through the connection member  12  and the restriction member  13 . In this instance, the puncture needle  11  can be rectified into a rectilinear shape by the restriction member  13 , together with the curved portion  314  of the sheath  30  such that the living body can be rectilinearly punctured, that is, to perform the first puncture. 
     Then, the second puncture is performed during when the needle tip  111  of the puncture needle  11  is moved past the obturator foramen  1101  and through a region between the urethra  1300  and the vagina  1400  and crosses (passes) the obturator foramen  1102  (the obturator foramen on the other side) (see  FIG. 14 ). In this second puncture, the puncture needle  11  protrudes gradually from the restriction member  13 , together with the curved portion  314  of the sheath  30 . In this instance, the restriction by the restriction member  13  is lifted, and the curved portion  314  returns into the curved state. As a result, the puncture needle  11  follows the curved state of the curved portion  314 , for example, lies along the curved shape of the curved portion  314 , which punctures the living body in an arcuate shape, that is, to perform the second puncture. 
     In accordance with an exemplary embodiment, after the needle tip  111  of the puncture needle  11  crosses the obturator foramen  1102  and until the needle tip  111  protrudes from the body surface H, the first puncture is again performed (see  FIG. 15 ). In this first puncture, a state is maintained in which the mounting portion  37  of the sheath  30  is mounted on the connection member  12  and movement of the sheath  30  is stopped, and only the puncture needle  11  is moved. In this case, the puncture needle  11  is also released from the restriction by the curved portion  314 , and moves straight forward as it is, for example, and moves in a tangential direction in regard of the curved portion  314  such that the living body can be rectilinearly punctured, that is, to perform the first puncture. 
     In accordance with an exemplary embodiment, in this way, the curvature-changing unit  14  can enable the puncture needle  11  to be operated so as to sequentially perform the first puncture, the second puncture, and the first puncture in this order. 
     Meanwhile, depending on a body type of the patient, for example, in the case of a comparatively large patient, the puncture needle  11  may be curved in an arcuate shape immediately upon puncturing. In such a situation, the urethra  1300  is present on a forward side in an intended direction of travel of the needle tip  111 . If the puncturing operation is continued under this condition, erroneous puncturing of the urethra  1300  can occur. In the puncture apparatus  1 , however, the curvature-changing unit  14  can enable the first puncture to be performed until the needle tip  111  comes to a position avoiding the urethra  1300 . Accordingly, the above disclosed erroneous puncturing can be relatively prevented. 
     In accordance with an exemplary embodiment, that while the curvature-changing unit  14  is composed essentially of the sheath  30 , the connection member  12 , and the restriction member  13  in this exemplary embodiment as disclosed above not restrictive. For example, the connection member  12  may be omitted. 
     As shown in  FIGS. 1 and 4 , the insertion instrument  6  can include a urethral insertion portion (second insertion portion)  41  to be inserted into the urethra  1300 , a vaginal insertion portion (first insertion portion)  51  to be inserted into the vagina  1400 , and the support part  60  supporting the urethral insertion portion  41  and the vaginal insertion portion  51 . As disclosed above, the insertion instrument  6  can be composed essentially of the urethral insertion member  4  and the vaginal insertion member  5 . The urethral insertion member  4  has the urethral insertion portion  41 , and the vaginal insertion member  5  has the vaginal insertion portion  51 . In addition, the support part  60  can include a support portion  40  which is possessed by the urethral insertion member  4  and supports the urethral insertion portion  41  and a support portion  50  which is possessed by the vaginal insertion member  5  and supports the vaginal insertion portion  51 . In the insertion instrument  6 , the urethral insertion member  4  and the vaginal insertion member  51  can be freely detachable by way of the support portions  40  and  50 , respectively. 
     In accordance with an exemplary embodiment, the urethral insertion member  4  can include the elongated urethral insertion portion  41  whose portion ranging from a distal end to an intermediate portion of the urethral insertion member  4  can be inserted into a urethra  1300 , and the support portion  40  which supports the urethral insertion portion  41 . In the following disclosure, for convenience of description, that portion of the urethral insertion member  4  which is located inside the urethra  1300  (inclusive of a bladder  1310 ) in the mounted state will be referred to also as “insertion portion  411 ,” whereas that portion of the urethral insertion member  4  which is exposed via a urethra orifice to the outside of the body in the mounted state and which ranges to the support portion  40  will be referred to also as “non-insertion portion  412 .” 
     The urethral insertion portion  41  can be in the shape of a tube with its distal end rounded. In addition, the insertion portion  411  is provided at its distal portion with an inflatable and deflatable balloon  42  and a urine drain portion  47 . The balloon  42  can function as a restriction portion restricting a position in an axial direction of the urethral insertion member  4  in the inside of the urethra  1300 . For example, when the puncture apparatus  1  is used, the balloon  42  can be inflated after inserted into a patient&#39;s bladder  1310 . Then, with the balloon  42  caught on a bladder neck, the position of the urethral insertion member  4  relative to the bladder  1310  and the urethra  1300  can be fixed. For example, in accordance with an exemplary embodiment, the urine drain portion  47  can be used for draining urine present inside the bladder  1310 . 
     The balloon  42  can extend through the inside of the urethral insertion portion  41 , to be connected to a balloon port  43  provided at a proximal portion of the urethral insertion portion  41 . A balloon-inflating instrument such as a syringe can be connected to the balloon port  43 . When a working fluid (a liquid such as physiological salt solution, or a gas or the like) is supplied from the balloon-inflating instrument into the balloon  42 , the balloon  42  is inflated. On the contrary, when the working fluid is drawn out of the balloon  42  by the balloon-inflating instrument, the balloon  42  is deflated. In  FIG. 4 , the balloon  42  in its deflated state is drawn in two-dot chain line, whereas the balloon  42  in its inflated state is drawn in solid line. 
     In accordance with an exemplary embodiment, the urine drain portion  47  can be provided with a drain hole  471  providing communication between an inside and an outside of the urine drain portion  47 . In addition, the urine drain portion  47  can extend through the inside of the urethral insertion portion  41 , to be connected to a urine drain port  48  provided at a proximal portion of the urethral insertion portion  41 . Thus, in accordance with an exemplary embodiment, the urine introduced through the drain hole  471  into the urine drain portion  47  can be drained via the urine drain port  48 . 
     The balloon  42  and the urine drain portion  47  can be configured by use of a double lumen, for example. 
     In addition, the insertion portion  411  is formed with a plurality of suction holes  44  at an intermediate portion of the insertion portion  411 . The plurality of suction holes  44  can be laid out over a whole range in a circumferential direction of the urethral insertion portion  41 . Each of the suction holes  44  is connected to a suction port  45  provided at a proximal portion of the urethral insertion portion  41 , via the inside of the urethral insertion portion  41 . A suction device such as a pump can be connected to the suction port  45 . When the suction device is operated in a state wherein the urethral insertion portion  41  is inserted in the urethra  1300 , a urethral wall can be sucked and fixed onto the urethral insertion portion  41 . When the urethral insertion portion  41  is pushed in toward the distal end (toward the inside of the body) under this condition, the urethra  1300  is also pushed in together with the urethral insertion portion  41 . As a result, for example, the bladder  1310  can be shifted to such a position as not to overlap with a puncture route for the puncture member  3 A, whereby the puncture route for the puncture member  3 A can be secured. Therefore, puncturing by the puncture member  3 A can be carried out relatively accurately and relatively safely. The number of the suction holes  44  is not limited; for example, the number may be one. Besides, a layout of the suction holes  44  is not restricted, for example, the suction holes  44  may be formed in only a part of the range in the circumferential direction of the urethral insertion portion  41 . 
     In addition, at a boundary between the insertion portion  411  and the non-insertion portion  412 , a marker  46  can be provided with which to check a depth of insertion of the urethral insertion portion  41  into the urethra  1300 . When the urethral insertion portion  41  is inserted in the urethra  1300  and the balloon  42  is located inside the bladder  1310 , the marker  46  is located at the urethral orifice, which permits relatively easy checking of the depth of insertion of the insertion portion  411  into the urethra  1300 . The marker  46  can be necessary only to be externally visible, and can be composed essentially of, for example, a colored portion, a recessed and projected portion, or the like. In accordance with an exemplary embodiment, a graduation with indications of distance from the distal end of the urethral insertion portion  41  may be provided, in place of the marker  46 . 
     A length of the insertion portion  411  is not limited, and may be set, as necessary, for example, according to a length of the urethra  1300  and a shape of the bladder  1310  of the patient, or the like. In accordance with an exemplary embodiment, the length of the insertion portion  411 , for example, is preferably about 50 to 100 mm, in view of the fact that the length of a female urethra  1300  is generally about 30 to 50 mm. 
     A length of the non-insertion portion  412  (a spacing between the urethral orifice and the support portion  40 ) is not limited. For example, the length is preferably not more than about 100 mm, preferably in the range of about 20 to 50 mm. By such a setting, the length of the non-insertion portion  412  can be made appropriate, which can enhanced operability. For example, if the length of the non-insertion portion  412  exceeds the above-mentioned upper limit, a center of gravity of the puncture apparatus  1  would, depending on the configuration of the frame  2  or the like factors, can be largely deviated from the patient, possibly leading to a lowered stability of the puncture apparatus  1  in the mounted state. 
     The material constituting the urethral insertion member  4  is not restricted. Examples of the material applicable here include various metallic materials such as stainless steels, aluminum, aluminum alloys, titanium, titanium alloys, etc. and various resin materials. 
     In accordance with an exemplary embodiment, an inclination angle θ2 of the plane f9 relative to a plane f2 orthogonal to an axis J2 of the urethral insertion portion  41  can be, for example, about 20 to 60 degrees, more preferably about 30 to 45 degrees, and further preferably about 35 to 40 degrees. For example, the main body  31  is preferably set indwelling in the body so that the angle formed between the plane f9 and a plane orthogonal to the axis of the urethra  1300  is, for example, about 20 to 60 degrees, more preferably about 35 to 45 degrees, and further preferably about 30 to 45 degrees. In accordance with an exemplary embodiment, such a setting makes it possible to easily perform the puncturing by the puncture member  3 A and to make shorter the distance of puncture by the puncture member  3 A. 
     In accordance with an exemplary embodiment, setting the inclination angle θ2 to within the above-mentioned range can help ensure that the puncture member  3 A can capture the left and right obturator foramens  1101  and  1102  of the pelvis  1100  wider on a planar basis, so that a wide puncturing space for the puncture member  3 A can be secured. For example, in a condition where a patient is put in a predetermined posture (lithotomy position), puncturing by the puncture member  3 A can be performed in a direction comparatively nearer to a perpendicular direction relative to the obturator foramens  1101  and  1102 . Therefore, the puncturing by the puncture member  3 A can be carried out relatively easily. In addition, since the puncturing by the puncture member  3 A is performed in a direction comparatively nearer to the perpendicular direction relative to the obturator foramens  1101  and  1102 , it can help ensure that the puncture member  3 A passes through a shallow part of tissue, so that the puncture member  3 A can cross a region between the left and right obturator foramens  1101  and  1102  by passing a short distance. Accordingly, as shown in  FIG. 5B , the puncture member  3 A can be passed through those regions of the obturator foramens  1101  and  1102  which are near a pubic symphysis  1200 , for example, through safety zones S5. Since safety zones S5 are regions where there are few nerves and blood vessels the damage to which is to be obviated, puncturing by the puncture member  3 A can be performed relatively safely. In addition, the result is relatively minimal invasiveness, and whereby burden on the patient can be relatively suppressed. Thus, with the inclination angle θ2 set to within the above-mentioned range, puncturing of a patient by the puncture member  3 A can be appropriately performed. In addition, by puncturing at the above-mentioned angle, it is facilitated to aim at a tissue between a middle-part urethra (which refers to an intermediate part in a lengthwise direction of the urethra  1300 ) and the vagina  1400 . The position between the middle-part urethra and the vagina  1400  is a position suitable as a site where to embed the implant  9  for treatment of urinary incontinence. 
     In accordance with an exemplary embodiment, for example, in the case where the inclination angle θ2 is less than the aforementioned lower limit or in excess of the aforementioned upper limit, there may arise an issue in that, depending on an individual differences concerning the patient or a posture during the procedure or the like factors, the puncture member  3 A cannot capture the obturator foramens  1101  and  1102  wide on a planar basis or the puncture route cannot be made sufficiently short. 
     In accordance with an exemplary embodiment, for example, the puncturing can be conducted in a condition where either one or both of the urethra  1300  and the vagina  1400  are positionally shifted so as to be pushed toward the inside of the body. Such an operation help permits relatively easy puncturing of the tissue between the middle-part urethra and the vagina  1400 . The method pushing in either one of the urethra  1300  and the vagina  1400  toward the inside of the body may be, for example, a method in which the urethral insertion member  4  and/or the vaginal insertion member  5  is inserted into an appropriate position, then, in this condition, the urethra  1300  and/or the vagina  1400  is sucked by the suction holes  44  and  59  (disclosed later) possessed by these members  4  and  5 , and thereafter the urethral insertion member  4  and/or the vaginal insertion member  5  is further moved toward the inside of the body along the axis thereof until reaching a predetermined position. In the condition where at least one of the urethra  1300  and the vagina  1400  has thus been positionally shifted so as to be pushed in toward the inside of the body, the main body  31  of the sheath  30  is made to puncture the living body perpendicularly to the left and right obturator foramens  1101  and  1102  of the pelvis, whereby a passage can be formed in a position suited to implanting of the implant  9 . 
     In accordance with an exemplary embodiment, a setting can be made to cause an orbital path of the main body  31  of the sheath  30  to pass the safety zones S5 of the left and right obturator foramens  1101  and  1102  of the pelvis, at least one of the urethra  1300  and the vagina  1400  is positionally shifted toward the inside of the body so as to locate the orbital path between the middle-part urethra and the vagina  1400 , and puncturing is performed along the orbital path of the main body  31 , thereby forming the passage. 
     As shown in  FIGS. 1 and 4 , the vaginal insertion member  5  can include the elongated vaginal insertion portion (first insertion portion)  51  whose portion from a distal end to an intermediate portion of vaginal insertion portion  51  is inserted into a vagina  1400  and the support portion  50  supporting the vaginal insertion portion  51 . In the following, for convenience of description, that portion of the vaginal insertion member  5  which is located in the vagina  1400  in the mounted state will be referred to also as “insertion portion  511 ,” and that portion of the vaginal insertion member  5  which is exposed via a vaginal orifice to the outside of the living body in the mounted state and which ranges to the support portion  50  will be referred to also as “non-insertion portion  512 .” 
     In accordance with an exemplary embodiment, the insertion portion  511  can be elongated. In addition, the insertion portion  511  can extend at an inclination relative to the insertion portion  411  so that the insertion portion  511  is spaced from the insertion portion  411  on the distal end. With the insertion portion  511  inclined relative to the insertion portion  411 , a positional relationship between the insertion portions  411  and  511  can be set closer to the positional relationship between the urethra  1300  and the vagina  1400 , as compared with the case where the insertion portion  511  is not inclined in this way. In the mounted state, the puncture apparatus  1  can be stably held onto the patient, and the relative burden on the patient can be mitigated. An inclination angle θ3 of the insertion portion  511  relative to the insertion portion  411  is not limited; for example, the inclination angle θ3 can be about 0 to 45 degrees, more preferably about 0 to 30 degrees, which can enable the above-mentioned effect to be displayed conspicuously. In accordance with an exemplary embodiment, in the case where the inclination angle θ3 is less than the aforementioned lower limit or in excess of the aforementioned upper limit, there may arise an issue in that, depending on individual differences concerning the patient or the posture during the procedure or the like factors, the urethra  1300  and/or the vagina  1400  may be deformed unnaturally in the mounted state, possibly hampering the puncture apparatus  1  from being stably held. 
     As shown in  FIG. 6 , the insertion portion  511  is in a flat shape collapsed in a vertical direction of the puncture apparatus  1  (in an array direction of the urethra  1300  and the vagina  1400 ). In addition, the insertion portion  511  has a central portion having a substantially constant width and a somewhat rounded distal portion. A length L2 of the insertion portion  511  is not limited, and can be, for example, about 20 to 100 mm, more preferably about 30 to 60 mm. A width W1 of the insertion portion  511  is not restricted, and can be, for example, about 10 to 40 mm, more preferably about 20 to 30 mm. In addition, a thickness of the insertion portion  511  is not limited, and can be, for example, about 5 to 25 mm, more preferably about 10 to 20 mm. Set to have such length, width, and thickness, as disclosed, the insertion portion  511  can be suited in shape and size to most vaginas. Therefore, stability of the puncture apparatus  1  in the mounted state can be enhanced, and burden on the patient can be relatively alleviated. 
     In addition, an upper surface (a surface on the urethral insertion portion  41  side)  511   a  of the insertion portion  511  can be formed with a plurality of bottomed recesses  53 . The number of the recesses  53  is not limited; for example, the number may be one. In accordance with an exemplary embodiment, each recess  53  can be provided with a single suction hole  59  in its bottom surface. Each suction hole  59  can be connected to a suction port  54  provided at a proximal portion of the insertion portion  511 , through the inside of the insertion portion  511 . The suction port  54  can also be located in the outside of the living body in the mounted state. A suction device such as a pump can be connected to the suction port  54 . When the suction device is operated in the condition where the insertion portion  511  is inserted in the vagina  1400 , an anterior wall of vagina,  1410 , which is an upper surface of a vaginal wall, is sucked and fixed onto the insertion portion  511 . When the vaginal insertion portion  51  with the vaginal wall is sucked and fixed thereon is pushed toward the distal end (toward the inside of the body), the vaginal wall can be pushed in together with the vaginal insertion portion  51 . Thus, a configuration and a shape of the vaginal wall, which can help secure a puncture route for the puncture member  3 A can be obtained, and the puncture member  3 A can accurately and safely perform the puncturing as disclosed herein. 
     A region S2 in which the plurality of recesses  53  are formed is disposed opposite to a region S1. The needle tip  111  of the puncture member  3 A passes between these regions S1 and S2. Since the urethra  1300  (which is a lower surface of the urethral wall) is sucked onto the insertion portion  411  in the region S1 and the anterior wall of vagina,  1410 , is sucked onto the insertion portion  511  in the region S2, as above-mentioned, the urethral wall and the vaginal wall are spaced wider apart from each other between the regions S1 and S2. By causing the puncture member  3 A to pass such a region, therefore, the puncturing by the puncture member  3 A can be performed safely. 
     The region S2 ranges over substantially a whole region in a width direction of the upper surface  511   a . A width W2 of the region S2 is not limited, and can be, for example, about 9 to 39 mm, more preferably about 19 to 29 mm, which can help enable the anterior wall of vagina,  1410 , to be reliably sucked onto the insertion portion  511 , without being much influenced by the shape of the vaginal wall. For example, in some patients, the vagina  1400  may be so shaped that part of the anterior wall of vagina,  1410 , is hanging down into the inside of the vagina  1400 , as shown in  FIG. 7A . Even in such a case, setting the width W2 to within the above-mentioned range ensures that not only the hanging-down portion but also the portions on both sides of the hanging-down portion can be sucked in an assured manner, as shown in  FIG. 7B . Therefore, the anterior wall of vagina,  1410 , can be reliably spaced from the urethra  1300 , without being affected by the shape of the vagina  1400 . For example, in this exemplary embodiment, the insertion portion  511  is flat-shaped, so that the anterior wall of vagina,  1410 , can be sucked so as to be spaced apart from the urethra  1300 . In accordance with an exemplary embodiment, the biological tissue between the urethral wall and the vaginal wall can be expanded (spread). 
     In addition, the insertion portion  511  can be include a marker (puncture position checking portion)  57  with which a puncture route for the puncture apparatus  1  can be checked. For example, the puncture apparatus  1  can be so fixed as to puncture a region (biological tissue) between the vaginal wall present on an upper side of the position where the marker  57  is located and the urethral wall. Therefore, operability and safety of the insertion instrument  6  can be enhanced. The marker  57  can be provided at least on a lower surface  511   b  of the insertion portion  511 . The lower surface  511   b  is a surface which is oriented toward the vaginal orifice can be visually confirmed by the operator via the vaginal orifice, in the mounted state. With the marker  57  provided on the lower surface  511   b , the puncture route for the puncture apparatus  1  can be reliably checked. In addition, the depth of insertion of the insertion portion  511  into the vagina can be checked. The marker  57  is necessary only to be externally visible, and can be configured by use of, for example, a colored portion, a recessed and projected portion, or the like. 
     In accordance with an exemplary embodiment, the non-insertion portion  512  can be in the shape of a thin bar which extends substantially parallel to the urethral insertion portion  41 . A spacing D between the non-insertion portion  512  and the urethral insertion portion  41  is not limited, and can be, for example, about 5 to 40 mm, correspondingly to the spacing between the urethral orifice and the vaginal orifice in common women. 
     A length of the non-insertion portion  512  (a spacing between the vaginal orifice and the support portion  50 ) is not restricted, and can be, for example, not more than about 100 mm, preferably in the range of about 20 to 50 mm, which can permit the non-insertion portion  512  to be appropriate in length, leading to enhanced operability. For example, if the length of the non-insertion portion  512  exceeds the above-mentioned upper limit, the center of gravity of the puncture apparatus  1  would, depending on the configuration of the frame  2  or the like factors, be largely deviated from the patient, possibly leading to a lowered stability of the puncture apparatus  1  in the mounted state. 
     The support portion  50  can be provided with a male screw  501 . With the male screw  501  fastened into a female screw (not shown) formed in the support portion  40 , the support portions  40  and  50  can be fixed to each other. 
     The material constituting the vaginal insertion member  5  is not restricted. Examples of the material applicable here include various metallic materials such as stainless steels, aluminum, aluminum alloys, titanium, titanium alloys, etc. and various resin materials, like the examples of the material for the urethral insertion member  4 . 
     In accordance with an exemplary embodiment, the urethral insertion member  4  and the vaginal insertion member  5  constituting the insertion instrument  6  can be freely detachable in the puncture apparatus  1 , this configuration is not restrictive. For example, a configuration may be adopted in which the urethral insertion member  4  and the vaginal insertion member  5  are non-detachable. 
     In addition, while the urethral insertion portion  41  is fixed to the support portion  40  in the puncture apparatus  1 , this configuration is not restrictive. For example, a configuration may be adopted wherein the urethral insertion portion  41  can be selectively switched between a state of being fixed to the support portion  40  and a state of being slidable in the axial direction relative to the support portion  40 . In accordance with an exemplary embodiment, for example, a configuration may be adopted wherein untightening of a screw provided on the support portion  40  can permit the urethral insertion portion  41  to be slid relative to the support portion  40 , whereas tightening the screw can render the urethral insertion portion  41  fixed to the support portion  40 . This configuration can enable regulation of the length of the non-insertion portion  412 , which makes the insertion instrument  6  user-friendly. In accordance with an exemplary embodiment, this can also apply to the vaginal insertion portion  51 . 
     In accordance with an exemplary embodiment, the members can be fixed to the frame  2  so that the inclination angle θ2 will be constant in the puncture apparatus  1 , and wherein this configuration is not restrictive. Thus, the inclination angle θ2 may be variable, which can permit the inclination angle θ2 to be controlled according to the patient to be treated, which can improve the utility of the puncture apparatus  1 . 
     In accordance with an exemplary embodiment, the implant  9  can be used together with the puncture apparatus  1  as disclosed below. As shown in  FIG. 15 , the implant (biological tissue-supporting indwelling body)  9  is an embeddable (implantable) instrument for treatment of female urinary incontinence, for example, an instrument supporting the urethra  1300 . For example, when the urethra  1300  tends to move toward the vaginal wall side, the implant  9  supports the urethra  1300  in such a manner as to restrict its movement in a direction of coming away from the vaginal wall. As the implant  9 , for example, a flexible elongate body can be used. 
     The implant  9  can include an implant main body (band-shaped elongate body)  91 , and a bag-shaped wrapping material  92  accommodating the implant main body  91 . In addition, the implant main body  91  can include a main body portion  911 , and a band  912  interlocked to one end of the main body portion  911 . With the implant  9  provided with the wrapping material  92 , contamination of the implant main body  91  can be effectively prevented. In accordance with an exemplary embodiment, a guide wire, braid, string or the like may be used in place of the band  912 . 
     In accordance with an exemplary embodiment, the main body portion  911  can be a reticulated band body. The main body portion  911  may be composed, for example, of a body obtained by intersecting linear members and knitting them into a reticulated form, for example, a reticulated braiding. Examples of the linear member include those which are circular in cross-sectional shape, those which are flat-shaped in cross section, etc. 
     The materials constituting the main body portion  911 , the band  912  and the wrapping material  92  are each not restricted. Examples of the materials applicable here can include various biocompatible resin materials such as polypropylene, polyesters, or nylon, and fibers, etc. 
     The implant  9  is not restricted to the above-mentioned reticulated body, insofar as it can produce an effect equivalent to the aforementioned. 
     A method of using the puncture apparatus  1  (operation procedure) is disclosed, and described below referring to  FIGS. 9A to 20 . By use of the puncture apparatus  1  (by the puncturing method) a bow-like puncture hole can be formed by placing the implant  9  indwelling in a biological tissue, prior to placement of the implant  9  between the urethra  1300  and the vagina  1400 . 
     First, a patient is put in a lithotomy position on an operating table, and the insertion instrument  6  is mounted onto the patient, as shown in  FIG. 9A . Specifically, first, the urethral insertion portion  41  of the urethral insertion member  4  is inserted into the patient&#39;s urethra  1300 . In this instance, while checking the depth of insertion by observing the marker  46 , the balloon  42  is disposed inside the bladder  1310 . The urethra  1300  is rectified into a predetermined shape by the urethral insertion portion  41  having the predetermined shape. In the case of this exemplary embodiment, the urethra  1300  can be rectified into a rectilinear shape by the urethral insertion portion  41  having the rectilinear shape. 
     Next, the balloon  42  is inflated, and, if necessary, urine is drained from the inside of the bladder  1310  through the drain hole  471 . In addition, the vaginal insertion portion  51  of the vaginal insertion member  5  can be inserted into the patient&#39;s vagina  1400 . In this instance, while checking the puncture position by observing the marker  57 , the vaginal insertion portion  51  can be inserted to an appropriate depth. Then, the male screw  501  is operated, to fix the support portions  40  and  50 . By this, mounting of the insertion instrument  6  onto the patient is completed. In this state, the non-insertion portions  412  and  512  are spaced from each other, the support part  60  is spaced from the body surface between the urethral orifice and the vaginal orifice, and that body surface is exposed. In addition, in the case where the insertion portion  511  and the anterior wall of vagina,  1410 , are spaced from each other and a gap (space) is formed therebetween, a space S3 causing a syringe to puncture from the body surface between the urethral orifice and the vaginal orifice to a biological tissue between the urethra and the vagina is formed. 
     Subsequently, suction devices can be connected to the suction ports  45  and  54 , and the suction devices are operated, whereby the urethra  1300  is sucked onto the urethral insertion portion  41 , and the anterior wall of vagina,  1410 , is sucked onto the vaginal insertion portion  51 . For example, when the urethra  1300  is properly sucked onto the urethral insertion portion  41 , the suction holes  44  are closed with the urethral wall, so that the suction via the suction port  45  is stopped or weakened. Similarly, when the anterior wall of vagina,  1410 , is properly sucked onto the vaginal insertion portion  51 , the suction holes  59  are closed with the vaginal wall, so that the suction via the suction port  54  is stopped or weakened. Therefore, based on the conditions of suction via the suction ports  45  and  54  (for example, the magnitude of sounds generated attendant on the suction via the suction ports  45  and  54 ), the operator can check whether or not the urethra  1300  and the anterior wall of vagina,  1410 , have been properly sucked onto the urethral insertion portion  41  and the vaginal insertion portion  51 , respectively. In accordance with an exemplary embodiment, the insertion instrument  6  may be provided with a checking mechanism for mechanical checking of the sucked state. The checking mechanism is not restricted, insofar as it enables checking of the sucked state. For example, the checking mechanism may be configured to include a flow measurement unit (negative-pressure sensor) measuring a flow rate through the suction port  54  and a decision unit deciding whether or not the sucking is being properly done, based on the measurement results sent from the flow measurement unit. 
     Next, humoral dissection can be performed. In accordance with an exemplary embodiment, as shown in  FIG. 9B , the puncture needle of a syringe  2000  is caused to puncture the anterior wall of vagina,  1410 , by way of the space (space S3) between the insertion portion  511  and the anterior wall of vagina,  1410 , and a liquid such as physiological salt solution or local anesthetic is injected into the biological tissue between the urethra  1300  and the vagina  1400  (between the regions S1 and S2). As a result, the biological tissue between the regions S1 and S2 is expanded, the urethra  1300  is pressed against the urethral insertion portion  41 , and the anterior wall of vagina,  1410 , is pressed against the vaginal insertion portion  51 . 
     In accordance with an exemplary embodiment, the suction through the suction holes  44  and  59  can be continuously conducted also during the humoral dissection. When the urethra  1300  is pressed against the urethral insertion portion  41  due to the humoral dissection, the urethra  1300  is further sucked onto the urethral insertion portion  41 , so that the suction via the suction port  45  is stopped or weakened. Similarly, when the anterior wall of vagina,  1410 , is pressed against the vaginal insertion portion  51 , the anterior wall of vagina,  1410 , is further sucked onto the vaginal insertion portion  51 , so that the suction via the suction port  54  is stopped or weakened. Based on the conditions of suction via the suction ports  45  and  54 , therefore, the operator can check whether the humoral dissection has been properly performed. 
     After the humoral dissection is conducted so that the urethra  1300  and the anterior wall of vagina,  1410 , are thereby sufficiently spaced from each other, the restriction member  13  is set indwelling on the body surface H at a right-hand inguinal region of the patient or at a region near the inguinal region. Then, as shown in  FIG. 10 , the insertion instrument  6  can be fixed to the frame  2 , which can result in the puncture apparatus  1  being mounted on the patient. In this state, a positional relationship between the pelvis  1100  and the puncture apparatus  1  is as shown in  FIG. 11 . In addition, as shown in  FIG. 12 , a flange portion  132  of the restriction member  13  can be engaged with the engaging portion  224  of the guide portion  22  of the frame  2 , which can result in the restriction member  13  being pressed against and fixed to the body surface H. Furthermore, the connection member  12  can be connected to the restriction member  13 . 
     Next, for example, while grasping the grasping portion  21  or the interlock portion  23  of the frame  2  by one hand, the puncture needle  11  inserted and passed in the sheath  30  is pushed into the restriction member  13  through the connection member  12 , as shown in  FIG. 13 , by the other hand. In this instance, the needle tip  111  of the puncture needle  11  is slightly protruding from the distal opening portion of the sheath  30 . 
     Then, as the puncture needle  11  is gradually pushed into the sheath  30 , the first puncture is performed as disclosed above. 
     When the operation of pushing the puncture needle  11  together with the sheath  30  is continued further, the second puncture is performed as above-mentioned. As shown in  FIG. 14 , the puncture route of the puncture needle  11  in the second puncture is a route of passing the obturator foramen  1101 , the region between the urethra  1300  and the vagina  1400 , and the obturator foramen  1102 . In this instance, between the urethra  1300  and the vagina  1400 , the puncture needle  11  and the sheath  30  are in a state as shown in  FIG. 18 . In accordance with an exemplary embodiment, the second puncture can be performed until the mounting portion  37  of the sheath  30  is mounted on the connection member  12  and movement of the sheath  30  is thereby stopped. 
     Subsequently, as shown in  FIG. 15 , only the puncture needle  11  is gradually pushed in, whereby the first puncture is again performed as disclosed above. Because of this puncture, the needle tip  111  protrudes from the body surface H at the left-hand inguinal region or at a region near the inguinal region to the outside of the body. Thereafter, while taking the implant main body  91  out of the wrapping material  92 , the band  912  is passed through a through-hole (not shown) provided in the vicinity of the needle tip  111  of the puncture needle  11 , which can result in the implant main body  91  and the puncture needle  11  being interlocked with each other. 
     Next, as shown in  FIG. 16 , while keeping the sheath  30  indwelling in the living body, the puncture needle  11  can be pulled in the reverse direction to the aforementioned, to be pulled out of the sheath  30 , which can cause the implant main body  91  to be pulled together with the puncture needle  11  and be inserted and passed in the sheath  30 , in place of the puncture needle  11 . Thus, the implant main body  91  can be kept accommodated in the wrapping material  92  until immediately before being disposed within the sheath  30 , such that contamination of the implant main body  91  can be relatively prevented. 
     In addition, if necessary, the position of the sheath  30  can be put into working order. For example, to shift the sheath  30  toward the proximal end or the distal end so that the central portion S4 of the main body  31  will be located between the urethra  1300  and the vagina  1400  as assuredly as possible. This results in that, as shown in  FIG. 19 , the central portion S4 is disposed with its width direction (the direction of the major axis J32) substantially in parallel to the urethra  1300 . Specifically, the urethra  1300  straightened by the insertion of the urethral insertion member  4  therein and the width direction of the central portion S4 are located substantially in parallel to each other. Furthermore, since the central portion S4 is flat-shaped, it is preferable that a posture of the main body portion  911  of the implant main body  91  follows the flat shape. In other words, as shown in  FIG. 19 , the main body portion  911  is disposed within the sheath  30  in such a manner that its width direction coincides with the width direction of the central portion S4. As for relationship with the urethra  1300 , the implant main body  91  is disposed in parallel to the straightened urethra  1300 . 
     Subsequently, as shown in  FIG. 17 , the puncture needle  11  is taken out of the implant main body  91 , and the frame  2  is detached from the patient. Besides, the sucking of the urethra  1300  by the urethral insertion portion  41  and the sucking of the anterior wall of vagina,  1410 , by the vaginal insertion portion  51  are stopped. Because of this, the positions and shapes of the urethra  1300  and the vagina  1400  are returned into their original natural state. 
     Thereafter, the sheath  30 , the restriction member  13 , and the connection member  12  are collectively drawn out of the living body. As the sheath  30  is gradually taken out of the living body, the surrounding tissue having been forced spread or expanded by the sheath  30  returns into an original position, and the tissue comes into contact with the implant main body  91  gradually from one end side toward the other end side of the implant main body  91 , which can help ensure that the implant main body  91  can be placed indwelling in an as-is state, with no unnecessary tensile force exerted on implant main body  91 , and thus no need for control of tension on the implant main body  91 . Because of these operations, the implant main body  91  is embedded in the living body, as shown in  FIG. 20 . In the state wherein the implant main body  91  is embedded in the living body, the main body portion  911  is disposed substantially parallel to the urethra  1300 , in the region between the urethra  1300  and the vagina  1400 . Consequently, the urethra  1300  can be supported by the implant main body  91  in a wider area. 
     Next, the urethral insertion member  4  is pulled out of the urethra  1300 , and the vaginal insertion member  5  is pulled out of the vagina  1400 . After the urethral insertion member  4  is pulled out, the urethra  1300  returns into its shape in the natural state. In this case, for example, since the main body portion  911  is left embedded in the tissue, the urethra  1300  in the natural state and the main body portion  911  can be maintained in a mutually parallel state. Thereafter, unnecessary portions of the implant main body  91  can be cut away, to complete the procedure. Since the sheath  30  is pulled out of the living body in the state wherein the urethral insertion member  4  is inserted in the urethra  1300 , it can help prevent an excessive tension from being exerted on the urethra  1300  by the implant main body  91  placed indwelling in the living body. 
     As above-mentioned, according to the puncture apparatus  1 , it is possible, in the process of puncturing a biological tissue to form a puncture hole, to appropriately change the curvature of the puncture needle  11  according to the depth of puncture. With the curvature of the puncture needle  11  thus varied, the puncture hole formed also can have a curvature varied along the longitudinal direction of puncture apparatus  1 , which can help ensure that the puncture hole is in the form of reliably passing between the urethra  1300  and the vagina  1400 . In this way, the puncture apparatus  1  helps ensure that puncturing of a biological tissue can be accurately performed. 
     In addition, according to the puncture apparatus  1 , implanting of the implant  9  can be dealt with by only a minimally invasive procedure such as puncturing with the puncture member  3 A of the puncture apparatus  1 , without need for highly invasive incision or the like. Consequently, the burden on the patient is slight, and safety for the patient is relatively high. In addition, issues encountered in the case of conventional incision of vagina can be prevented, such as the implant  9  being exposed to the inside of the vagina via a wound formed by the incision, or complications due to infection via the wound. Thus, the safety of the operation with the puncture apparatus  1  is relatively high, and the implant  9  can be reliably implanted. 
     Furthermore, since the implant main body  91  can be embedded parallel to the urethra  1300 , the urethra  1300  can be supported in a wider region. 
     In accordance with an exemplary embodiment, while the sheath  30  and the puncture needle  11  are inserted into the restriction member  13  in an assembled state as disclosed above in the series of procedure illustrated in  FIGS. 14 to 16 , this configuration is not restrictive. For example, inserting only the sheath  30  into the restriction member  13  and simply puncturing with the sheath  30  may also be adopted. In this case, for example, the sheath  30  can be advanced to a point where the curved portion  314  crosses the obturator foramen  1102 , the puncture needle  11  can be inserted into the sheath  30 , and the puncturing operation advanced. In accordance with an exemplary embodiment, the distal end of the sheath  30  is preferably so structured as to be able to puncture a living body. 
       FIGS. 21 and 22  are views illustrating an operation procedure of the puncture apparatus in accordance with a second exemplary embodiment of the present disclosure. The following description will center on differences from the above-described embodiment, and descriptions of the same items as those mentioned above will be omitted. This exemplary embodiment is the same as the first embodiment above, except for a difference in a configuration of a puncture member. 
     As shown in  FIGS. 21 and 22 , in a puncture member  3 B, a puncture needle  11  is composed essentially of a small piece interlock portion  113  having a plurality of small pieces  112  interlocked with one another, and a linear portion  114  extending proximally from the small piece interlock portion  113 . 
     In the small piece interlock portion  113 , the adjacent small pieces  112  are interlocked with each other by way of a recess and a projection. The small piece interlock portion  113  is rectilinearly shaped in a natural state (see  FIG. 21 ), and is elastically deformed when an external force is exerted on interlock portion  113  (see  FIG. 22 ). In addition, the small piece  112   a  located at the most distal position is provided with a sharp needle tip  111 . 
     In accordance with an exemplary embodiment, the linear portion  114  is higher than the small piece interlock portion  113  in rigidity. 
     The puncture member  3 B can be provided with an operating wire  15  as an operating portion deforming the puncture needle  11  into a curved shape. The operating wire  15  is inserted in and passed through the puncture needle  11 , and the distal end of the operating wire  15  is connected to the small piece  112   a  of the puncture needle  11 . In addition, the operating wire  15  is provided at its proximal portion with a grasping portion  151  to be grasped at the time of operating the operating wire  15 . With the grasping portion  151  grasped and with the operating wire  15  (puncture needle  11 ) pulled proximally, the puncture needle  11  is deformed into a curved shape. The curvature of the puncture needle  11  can vary in proportion to an amount by which the operating wire  15  is pulled. Thus, the operating wire  15  can function as a curvature-changing unit  14  changing the curvature of the puncture needle  11 . 
     In this exemplary embodiment, the puncture member  3 B can perform a first puncture and a second puncture. As shown in  FIG. 21 , at the time of performing the first puncture, the puncture needle  11  is in a rectilinear state under restriction by a restriction member  13 , which helps permit the first puncture to be carried out. As shown in  FIG. 22 , at the time of performing the second puncture, a pulling operation using the operating wire  15  is conducted in a condition where the restriction by the restriction member  13  has been lifted, whereby the puncture needle  11  is deformed into a curved state, which can allow the second puncture to be reliably carried out, and, accordingly, a region between a urethra  1300  and a vagina  1400  can be punctured. With the operating wire  15  loosened after the second puncture, the puncture needle  11  returns into the rectilinear shape, so that the first puncture can be performed. 
     The puncture needle  11  can have a marker  115  given to the linear portion  114 . With the operating wire  15  operated when the marker  115  overlaps with a body surface H, the puncture needle  11  is deformed into the curved shape, enabling transition to the second puncture. 
     Thus, in this exemplary embodiment, also, puncturing of a living body can accurately be carried out, whereby a puncture hole equivalent to that in the first embodiment disclosed above can be formed in the living body. 
       FIG. 23  is a side view showing a third exemplary embodiment of the puncture apparatus according to the present disclosure. The following description will center on differences from the above-described embodiments, and descriptions of the same items as those mentioned above will be omitted. This exemplary embodiment is the same as the second exemplary embodiment above, except for a difference in a configuration of a puncture member. 
     As shown in  FIG. 23 , a puncture member  3 C is provided with a lock mechanism  16  maintaining a curved state of a puncture needle  11 . The lock mechanism  16  is a mechanism which bears part of a curvature-changing unit  14 , and has a helical compression spring  161 . The helical compression spring  161  can be disposed in a compressed state between a flange portion  116  provided at a proximal portion of the puncture needle  11  and a flange portion  152  provided at a proximal portion of an operating wire  15 . 
     At a time of performing a first puncture, the flange portion  152  of the operating wire  15  is pushed in a direction compressing the helical compression spring  161 , thereby conducting the puncture. 
     In accordance with an exemplary embodiment, at a time of performing a second puncture, the push on the flange portion  152  is removed, and the puncture is conducted. When the push on the flange portion  152  is removed, the operating wire  15  is pulled proximally due to a restoring force of the helical compression spring  161 , and as a result, the puncture needle  11  is put into a curved state, which curved state is maintained. With the curved state thus maintained, the second puncture can be carried out relatively easily. 
       FIG. 24  is a side view showing a fourth exemplary embodiment of the puncture apparatus according to the present disclosure. The following description will center on differences from the above-described embodiments, and descriptions of the same items as those mentioned above will be omitted. This exemplary embodiment is the same as the second exemplary embodiment above, except for a difference in a configuration of a puncture member. 
     As shown in  FIG. 24 , in a puncture member  3 D, a puncture needle  11  is composed essentially of a wound portion  117  having a band-shaped body (or a linear body) wound spirally, and a linear portion  114  extending proximally from the wound portion  117 . 
     The wound portion  117  is rectilinearly shaped in a natural state (see  FIG. 24 ). In addition, the wound portion  117  can be elastically deformed by exerting an external force on the wound portion  117 , for example, by operating an operating wire  15 . As a result, the curvature of the wound portion  117  is changed. Accordingly, a first puncture and a second puncture can be performed sequentially. 
       FIGS. 25-37  are views showing a fifth exemplary embodiment of the puncture apparatus according to the present disclosure. In  FIGS. 28 ,  29 A,  29 B, and  29 C, the puncture member actually extending in an arcuate shape is illustrated in a rectilinearly stretched state, for convenience of description. The following description will center on differences from the above-described embodiments, and descriptions of the same items as those mentioned above will be omitted. This exemplary embodiment is the same as the first exemplary embodiment above, except for differences in a configuration of a puncture apparatus. 
     As shown in  FIG. 25 , the puncture apparatus  1  can include a frame  2 , a puncture member  3 E, a urethral insertion member  4 , a vaginal insertion member  5 , and an operating member  7 . The puncture member  3 E, the urethral insertion member  4 , and the vaginal insertion member  5  are supported on the frame  2 . A main difference of the puncture apparatus  1  in this exemplary embodiment from the puncture apparatus  1  in the first embodiment above lies in the puncture member  3 E. 
     As shown in  FIGS. 31 to 36 , the puncture member  3 E is puncturing a living body, while securing a target puncture route R, to form a puncture hole. As shown in  FIG. 28 , the puncture member  3 E includes a sheath  30 , a needle body  35  provided at a distal end of the sheath  30 , and an operating member  7  (insertion portion  71 ) operating the sheath  30 . The sheath  30  and the needle body  35  constitute a puncture needle. In addition, the sheath  30  has a tube-shaped main body  31 , and a state-maintaining mechanism  34 . 
     The operating member  7  is a member operating the sheath  30 . Such an operating member  7 , as shown in  FIG. 26 , can include the insertion portion  71 , a shaft portion  73 , and an interlock portion  72  interlocking the insertion portion  71  and the shaft portion  73  to each other. The insertion portion  71 , the interlock portion  72  and the shaft portion  73  may be formed integrally; or, alternatively, at least one of the portions may be formed as a separate body in relation to the other portions. 
     The insertion portion  71  is a portion to be inserted in the sheath  30 , and functions as a stylet that supports the sheath  30  from the inside. With the insertion portion  71  inserted in the sheath  30 , the sheath  30  can be interlocked to the operating member  7 , whereby it is enabled to turn the sheath  30  by the operating member  7 . Such an insertion portion  71  is in an arcuate shape corresponding to the shape of the sheath  30 . A center angle of the insertion portion  71  is set in conformity with a center angle of the sheath  30 . A distal portion  711  of the insertion portion  71  can be tapered off. In accordance with an exemplary embodiment, the presence of the tapered distal portion  711  can enable a smooth insertion of the insertion portion  71  into the sheath  30 . 
     The shaft portion  73  is a turning shaft which intersects a center O of the insertion portion  71  and serves as a center of turn of the sheath  30  (needle body  35 ). The shaft portion  73  extends along an axis J1 orthogonal to a plane f1 that contains the insertion portion  71 . 
     The interlock portion  72  interlocks a proximal portion of the insertion portion  71  and a distal portion of the shaft portion  73  to each other. In addition, the interlock portion  72  is substantially L-shaped, with a substantially rectangular bend at an intermediate portion of the L-shaped interlock portion  72 . The interlock portion  72  functions also as a grasping portion to be grasped by an operator at the time of operating the operating member  7 . 
     Such an operating member  7  can be configured to be higher than the sheath  30  in rigidity. The material constituting the operating member  7  is not restricted. Examples of the material applicable here include various metallic materials such as stainless steels, aluminum, aluminum alloys, titanium, and titanium alloys. 
     As shown in  FIGS. 27 and 28 , in this exemplary embodiment, a main body  31  of the sheath  30  can be curved in a bow-like shape, can be rigid, and can be composed of two split pieces so that it can be split at an intermediate portion of the main body  31 . For example, the main body  31  can be divided into a distal split piece  32  and a proximal split piece  33 . The distal split piece  32  and the proximal split piece  33  can be approximately equal in length, and their boundary is located at a central portion S4. 
     As shown in  FIG. 28 , the distal split piece  32  can be tubular in shape, and can have a distal end opening  321  and a proximal end opening  322 . Similarly, the proximal split piece  33  can be tubular in shape, and can have a distal end opening  331  and a proximal end opening  332 . A distal portion of the proximal split piece  33  can be inserted into a proximal portion of the distal split piece  32 , whereby the distal split piece  32  and the proximal split piece  33  are connected to each other. With the proximal split piece  33  thus inserted into the distal split piece  32 , a step which can be generated at a boundary between the split pieces  32  and  33  is insusceptible to be caught on a biological tissue, so that puncturing of a living body by the puncture member  3 E can be performed relatively smoothly. In accordance with an exemplary embodiment, the distal split piece  32  may be inserted into the proximal split piece  33  to connect the split pieces  32  and  33  to each other. 
     The material constituting the main body  31  can be, for example, a rigid material that can maintain the shape and an internal space of main body  31  in the state of being inserted in a body. Examples of such rigid material applicable can include various resin materials such as polyethylene, polyimides, polyamides, polyester elastomers, polypropylene, etc. and various metallic materials such as stainless steels, aluminum, aluminum alloys, titanium, and titanium alloys. In accordance with an exemplary embodiment, instead of adopting a rigid material constituting the main body  31 , other materials may also be adopted, in which case a wall of the main body  31  is reinforced with a reinforcement member, whereby the preferable properties as above-mentioned are attained. For instance, a high-strength braiding may be embedded in the wall of the main body  31 , whereby the shape and the internal space of the main body  31 , in the state of being inserted in a body, can be maintained. Another example of the reinforcement member is a spiral body, which may be embedded in the wall of the main body  31 , whereby the main body  31  can have flexibility while retaining the internal space to such an extent that an inserted body can be slid therein. 
     In accordance with an exemplary embodiment, the connected state of the split pieces  32  and  33  thus connected can be maintained by the state-maintaining mechanism  34 . As shown in  FIG. 29A , the state-maintaining mechanism  34  can include holes  342   a ,  342   b , and  342   c , an endless string (interlock member)  341  passed through the holes  342   a ,  342   b , and  342   c , exposure holes (through-holes)  345  and  346  exposing the string  341 , and a slit  347  joining the exposure holes  345  and  346 . 
     The hole  342   a  can be provided in a proximal portion of the proximal split piece  33 , for example, at a front surface A3 near an inner circumferential portion A1. The holes  342   b  and  342   c  can be oppositely provided in a proximal portion of the distal split piece  32 , for example, at the front surface A3 and a back surface A4 near the inner circumferential portion A1. 
     The string  341  is disposed inside the main body  31 . The string  341  can be exposed to the outside of the main body  31 , between the hole  342   b  and the hole  342   c , and between the hole  342   a  and the proximal end opening  332 . With the string  341  laid around in this manner, the connected state of the split pieces  32  and  33  can be securely maintained. In addition, the exposure of the string  341  to the outside of the main body  31  can be suppressed, so that the string  341  is less liable to be caught on a biological tissue. In addition, while making it possible to cut the string  341  as will be described later, an overall length of the string  341  can be made as short as possible. Therefore, at a time of inserting and passing an implant main body  91  into and through the main body  31  of the sheath  30 , the string  341  is less liable to be caught on the implant main body  91 . In addition, since the holes  342   a ,  342   b , and  342   c  are disposed near the inner circumferential portion A1 as above-mentioned, the string  341  is also disposed near the inner circumferential portion A1, which can ensure that at the time of inserting the implant main body  91  into the main body  31  of the sheath  30 , the string  341  is less liable to be caught on the implant main body  91 . 
     The string  341  can be obtained, for example, in the following manner. A string having ends is prepared. One end of the string is inserted through the proximal end opening  332  into the inside of the main body  31 , is drawn out via the hole  342   b  to the outside of the main body  31 , is inserted through the hole  342   c  into the inside of the main body  31 , is drawn out via the hole  342   a  to the outside of the main body  31 , and is finally tied with the other end of the string near the proximal end opening  332 . The position of the knot is not restricted. 
     As shown in  FIG. 29C , an axis of the hole  342   a  is so inclined that an outside opening of the hole  342   a  is located on the proximal end of an inside opening of the hole  342   a . As shown in  FIG. 29B , an axis of each of the holes  342   b  and  342   c  can be so inclined that an outside opening of the hole is locate on the distal end of an inside opening of the hole, which can enable the holes  342   a ,  342   b , and  342   c  to extend along the course of the string  341 , so that the string  341  is less liable to be caught on the holes  342   a ,  342   b , and  342   c.    
     The exposure holes  345  and  345  can be oppositely provided in the front surface A3 and in the back surface A4, at a proximal portion of the proximal split piece  33 . The part where the exposure holes  345  and  346  are provided protrudes from a body surface H, in the condition where the main body  31  is disposed in a body. Therefore, the string  341  is exposed via the exposure holes  345  and  346  to the outside of the main body  31 . In addition, the exposure holes  345  and  346  are joined by the slit  347  which is provided in the inner circumferential portion A1 along a circumferential direction of the main body  31 . 
     In the state-maintaining mechanism  34  as disclosed above, cutting the string  341  can result in a state wherein the distal split piece  32  and the proximal split piece  33  can be separated from each other. This configuration can ensure that the distal split piece  32  and the proximal split piece  33  can be put into a separable state by a simple operation. In addition, since the cutting of the string  341  can be visually checked, it can be easily confirmed that the distal split piece  32  and the proximal split piece  33  have been put into the separable state. 
     The exposure holes  345  and  346  and the slit  347  thus provided, as in this exemplary embodiment, enable easy cutting of the string  341 . For example, a pair of scissors having a pair of cutting blades (a first blade and a second blade) can be prepared. The first blade is inserted and passed in the exposure holes  345  and  346 , and the string  341  is located between the pair of blades. Then, the scissors is put into a closing operation, whereon at least one of the first and second blades passes the slit  347 , and the first and second blades overlap each other. During this process, the string  341  is cut. In this way, the exposure holes  345  and  346  and the slit  347  provided as above-mentioned enable easy cutting of the string  341 . 
     Thus, in this exemplary embodiment, the slit  347  is provided, and the slit  347  is used as a passing route for the blade, which can help ensure that deformation of the main body  31  due to a tension on the string  341  is relatively prevented. For example, as shown in  FIG. 30A , the passing route for the blade may be configured by use of a hole  348  in place of the slit  347 . In this case, however, the hole  348  may, depending on the hardness of the main body  31  or the like factor, be collapsed through buckling under the tension on the string  341 , and the main body  31  may be deformed thereby, as shown in  FIG. 30B . In the case of the slit  347 , those parts  347   a  and  347   b  on opposite sides of the slit  347  abut against each other, so that the above-mentioned deformation would not occur, and deformation of the main body  31  is relatively prevented, as shown in  FIG. 30C . 
     The number and layout of the holes ( 342   a ,  342   b ,  342   c ) through which to pass the string  341  are not limited, insofar as the connected state of the distal split piece  32  and the proximal split piece  33  can be maintained by the string  341 . In addition, the string  341  may not necessarily be in an endless form, but may have ends, namely, one end and the other end. For instance, a string having ends may be prepared, one end of the string may be passed through the hole  342   a  and the proximal end opening  332  and be looped, and the other end of the string may be passed through the holes  342   b  and  342   c  and be looped. Furthermore, the string  341  can include braiding, bands and the like that can be used in the same manner as the string  341 . 
     In addition, as shown in  FIG. 28 , the main body  31  is provided at its distal portion with a pair of engaging holes  315  and  316  to be used for other purpose, for example, facilitating the operation of the sheath  30 . Similarly, the main body  31  is provided at its proximal portion with a pair of engaging holes  317  and  318  to be used for other purpose. Of these four engaging holes, the engaging holes  315  and  317  are provided in the inner circumferential portion A1, whereas the engaging holes  316  and  318  are provided in the outer circumferential portion A2. 
     Besides, a spacing between the engaging holes  315  and  316  and the central portion S4 and a spacing between the engaging holes  317  and  318  and the central portion S4 are approximately equal, which can help ensure that the position of the central portion S4 of the main body  31  in a living body can be easily grasped. 
     The main body  31  as above is provided with the needle body  35  at the distal end of the main body  31 . As shown in  FIG. 28 , the needle body  35  has a needle tip  351  which is tapered off, and a proximal portion  352  provided on the proximal end of the needle tip  351 . The proximal portion  352  is inserted in the main body  31 , whereby the needle body  35  is held inside the main body  31  in a freely detachable manner. The proximal portion  352  is fitted in the main body  31  with such a force that unintended detachment of the needle body  35  from the main body  31  can be relatively prevented. Further, the needle body  35  may be configured integrally with the main body  31 . 
     In addition, the proximal portion  352  can be provided with an engaging portion  353  for engagement with the distal portion  711  of the insertion portion  71 . The engaging portion  353  can be composed essentially of a recess. In an inserted state wherein the puncture member  3 E is inserted in the insertion portion  71 , the distal portion  711  is located inside the engaging portion  353 . The engaging portion  353  thus provided ensures that displacement of the needle body  35  relative to the insertion portion  71  is suppressed, and puncturing of a living body by the puncture member  3 E can be carried out smoothly. 
     In the case where at least the distal portion  711 , of the insertion portion  71 , is flat-shaped in cross section, for example, the cross-sectional shape of the engaging portion  353  is set in conformity with the cross-sectional shape of the distal portion  711 , for example, the engaging portion  353  is also flat-shaped in cross section, which helps ensure that when the engaging portion  353  and the distal portion  711  are in engagement with each other, the flat shape of the engaging portion  353  and the flat shape of the distal portion  711  overlap each other. This overlap can help ensure that the sheath  30  is restrained from rotating relative to the insertion portion  71 , about the axis of the insertion portion  71 , for example, about an axis extending along the puncturing direction. Consequently, a curved puncture route which reliably passes between the urethra  1300  and the vagina  1400  can be secured. 
     The material constituting the needle body  35  is not restricted. For example, the same materials as those for the main body  31  can be used for the needle body  35 . 
     As shown in  FIG. 25 , a support unit  17  supporting the puncture member  3 E (operating member  7 ) is incorporated and disposed in a grasping portion  21  of the frame  2 . The support unit  17  can support the puncture member  3 E in such a manner that the puncture member  3 E can be turned about the shaft portion  73 . In addition, the support unit  17  can support the puncture member  3 E also in such a manner that the puncture member  3 E, while being turned about the shaft portion  73 , can be moved in a direction orthogonal to the shaft portion  73 , for example, in a horizontal direction in a use state (mounted state) of the puncture apparatus  1  in this exemplary embodiment. 
     As shown in  FIGS. 37A to 37D , the support unit  17  can include a pinion gear  171  which is fixedly provided on the shaft portion  73  and rotated together with the shaft portion  73 , and a rack  172  which is fixedly provided on the grasping portion  21  and meshes with the pinion gear  171 . 
     The pinion gear  171  has teeth  1711  formed along the circumferential direction of the shaft portion  73 , in a region of half the circumference. The rack  172  is so formed that an overall length of its toothed portion is equal to an overall length of the teeth  1711  of the pinion gear  171 , which can ensure that the support unit  17  can assume a state in which the pinion gear  171  is in mesh with the rack  172 , as shown in  FIGS. 37A to 37C , and a state in which the pinion gear  171  is out of mesh with the rack  172  and can be moved in the left-right direction in the figure while rotating idly, as shown in  FIG. 37D . 
     By the support unit  17  configured in this way, the puncture member  3 E is operated so as to sequentially perform a first puncture (a puncture depicted in  FIG. 31  through  FIG. 32 ), a second puncture (a puncture depicted in  FIG. 32  through  FIG. 35 ), and a first puncture (a puncture depicted in  FIG. 36 ). This can help ensure that the orbital path described by the needle tip  351  of the puncture member  3 E is a target puncture route R, and, accordingly, the puncture member  3 E punctures a living body along the target puncture route R. 
     A method of using the puncture apparatus  1  (operation procedure) in this exemplary embodiment will be described below, referring to  FIGS. 31 to 37D . 
     As shown in  FIG. 31 , the puncture apparatus  1  is set into the mounted state, and the needle tip  351  is set in abutment on a body surface H at the right-hand inguinal region of a patient or a region in the vicinity thereof (first region). In this instance, the support unit  17  is in a state as shown in  FIG. 37A . 
     Next, while grasping an interlock portion  23  of the frame  2  by one hand, for example, an interlock portion  72  of the operating member  7  is grasped by the other hand, and the operating member  7  is rotated clockwise, as shown in  FIG. 32 . This can help ensure that the needle tip  351  of the puncture member  3 E punctures the body surface H at the right-hand inguinal region of the patient or the region in the vicinity thereof (first region) by the first puncture, to enter the body. This first puncture is performed until the needle tip  351  reaches an obturator foramen  1101 . 
     As the rotating operation on the operating member  7  is further continued, as shown in  FIG. 33 , a transition to the second puncture takes place, and puncturing by the second puncture is started. 
     Then, when a turning angle of the operating member  7  as measured from the state shown in  FIG. 31  reaches 90 degrees, as shown in  FIG. 34 , the needle tip  351  crosses a region between the urethra  1300  and the vagina  1400 . For example, in this instance, the support unit  17  is in a state as shown in  FIG. 37B . 
     Thereafter, the living body can be punctured by the second puncture until immediately before the needle tip  351  passes an obturator foramen  1102 , as shown in  FIG. 35 . 
     When the turning angle of the operating member  7  as measured from the state shown in  FIG. 31  reaches 180 degrees, as shown in  FIG. 36 , the needle tip  351  has passed the obturator foramen  1102  and reaches a position immediately beneath the body surface H at the left-hand inguinal region or a region in the vicinity of the body surface H at the left-hand inguinal region. For example, in this instance, the support unit  17  is in a state as shown in  FIG. 37C . 
     As the rotating operation on the operating member  7  is further continued, as shown in  FIG. 37D , the pinion gear  171  is disengaged from the rack  172 , and the shaft portion  73  is rotated idly, which results in that the needle tip  351  protrudes from the body surface H to the outside of the body. 
     By the puncturing operation as above, a puncture hole in a bow-like shape can be formed in the living body proximate to the target puncture route R. This puncture needle also is in the state of reliably passing between the urethra  1300  and the vagina  1400 , like that in the first exemplary embodiment described above. Thus, the puncture apparatus  1  in this exemplary embodiment also can help ensure that puncturing of a biological tissue can be accurately carried out. 
     Next, the needle body  35  is detached from the sheath  30 , and the operating member  7  is rotated in a direction reverse to the aforementioned. This results in that the inserted portion  71  of the operating member  7  is pulled out of the sheath  30 , with the sheath  30  left in the living body. 
     Subsequently, the implant main body  91  is inserted into the sheath  30  while being taken out of a wrapping material  92 , and a band  912  is set into a state of protruding from the proximal end opening and the distal end opening of the sheath  30 . 
     Next, that portion of the string  341  which is exposed from the exposure holes  345  and  346  is cut. This results in a state in which the sheath  30  can be split into the distal split piece  32  and the proximal split piece  33 . The exposure holes  345  and  346  are located so as to be exposed to the outside of the living body, so that the cutting of the string  341  can be easily carried out. 
     Subsequently, the connection between the distal split piece  32  and the proximal split piece  33  is canceled, then the distal split piece  32  is pulled distally out of the living body, and the proximal split piece  33  is pulled proximally out of the living body. For example, in this case, the distal split piece  32  and the proximal split piece  33  are moved in the opposite directions substantially simultaneously, and the distal split piece  32  and the proximal split piece  33  are moved along an arcuate path such as to follow their own shape, which can permit the sheath  30  to be smoothly removed from the living body. As the distal split piece  32  and the proximal split piece  33  are gradually taken out of the living body as above-mentioned, the surrounding tissue having been forced open (expanded) by the sheath  30  returns into an original position, and the tissue comes into contact with the implant main body  91 , gradually from a central portion toward both end portions of the implant main body  91 . As above-mentioned, the distal split piece  32  and the proximal split piece  33  are moved in directions along their shapes, and the sheath  30  has an internal space such that the implant main body  91  can be moved therein under a sufficiently low friction, which can help ensure that the implant main body  91  can be placed indwelling in an as-is state, with no unnecessary tensile force exerted on the implant main body  91 . Accordingly, there is no need for control of tension on the implant main body  91 . As a result of these operations, the implant main body  91  is in the state of being embedded in the living body. 
     In addition, with the sheath  30  thus split into the split pieces and removed from the living body as the split pieces, pulling-out of the sheath  30  from the living body can be carried out rather easily. In addition, the pulling-out method can help ensure that the split pieces  32  and  33  being pulled out exert little influence on a posture of the main body portion  911  in the region between the urethra  1300  and the vagina  1400 . 
       FIGS. 38A and 38B  illustrate a support unit possessed by the puncture apparatus in accordance with a sixth exemplary embodiment of the present disclosure, wherein  FIG. 38A  is a plan view and  FIG. 38B  is a cross-sectional view. The following description will center on differences from the above-described embodiments, and descriptions of the same items as those mentioned above will be omitted. This exemplary embodiment is the same as the fifth exemplary embodiment above, except for a difference in a configuration of a support unit supporting a puncture member. 
     As shown in  FIGS. 38A and 38B , in this exemplary embodiment, a support unit  17  can include a first pinion gear  171 A and a second pinion gear  171 B which are fixedly provided on a shaft portion  73  of an operating member  7 ; and a first rack  172 A and a second rack  172 B which are fixedly provided on a grasping portion  21  of a frame  2 . 
     As shown in  FIG. 38A , the first pinion gear  171 A and the second pinion gear  171 B are disposed adjacently along the shaft portion  73 . In addition, the first rack  172 A is disposed so as to mesh with the first pinion gear  171 A, and the second rack  172 B is disposed so as to mesh with the second pinion gear  171 B. 
     As shown in  FIG. 38B , the first pinion gear  171 A has teeth  1712  and  1714 , and the second pinion gear  171 B has teeth  1713 . 
     In the support unit  17 , when the shaft portion  73  is rotated, the teeth  1712 ,  1713 , and  1714  are sequentially put into mesh in this order, attendant on the rotation. For example, when the shaft portion  73  is rotated, first, the teeth  1712  of the first pinion gear  171 A meshes with the first rack  172 A and comes out of mesh, during when the first pinion gear  171 A is rotated by a predetermined angle α1 (for example, 45 degrees). Next, the teeth  1713  of the second pinion gear  171 B meshes with the second rack  172 B and comes out of mesh, during when the second pinion gear  171 B is rotated by a predetermined angle α2 (for example, 90 degrees). Subsequently, the teeth  1714  of the first pinion gear  171 A meshes with the first rack  172 A and comes out of mesh, during when the first pinion gear  171 A is rotated by a predetermined angle α3 (for example, 45 degrees). 
     In addition, a gear ratio between the first pinion gear  171 A and the first rack  172 A and a gear ratio between the second pinion gear  171 B and the second rack  172 B are different from each other. For example, the former gear ratio is lower than the latter gear ratio. 
     When a first puncture (to be conducted first) is conducted, by use of the support unit  17  configured as above, the teeth  1712  of the first pinion gear  171 A meshes with the first rack  172 A. When a second puncture is performed, the teeth  1713  of the second pinion gear  171 B meshes with the second rack  172 B. When a first puncture (to be conducted last) is conducted, the teeth  1714  of the first pinion gear  171 A meshes with the first rack  172 A. By this process, the horizontal moving speed of the needle tip  351  can be varied. For example, the needle tip  351  is moved at a low speed in the first puncture and at a high speed in the second puncture. Accordingly, a puncture hole can be formed proximate to the target puncture route R. 
     The support unit  17 , a configuration may be adopted in which, unlike in the configuration of  FIG. 38B , the first pinion gear  171 A is provided with “teeth” in a range of the predetermined angle α2, and the second pinion gear  171 B is provided with “teeth” in ranges of the predetermined angles α1 and α3. 
       FIGS. 39-47  are views illustrating an operation procedure of the puncture apparatus in accordance with a seventh exemplary embodiment of the present disclosure. Now, referring to these figures, the seventh exemplary embodiment of the puncture apparatus and puncturing method according to the present disclosure will be described below. The following description will center on differences from the above-described embodiments, and descriptions of the same items as those mentioned above will be omitted. This exemplary embodiment is the same as the fifth exemplary embodiment above, except for a difference in a configuration of a support unit supporting a puncture member. 
     As shown in  FIGS. 39 and 40 , in this exemplary embodiment, a support unit  17  can support a puncture member  3 E in such a manner that the puncture member  3 E, while being turned about a shaft portion  73 , can be reciprocated in the vertical direction in the use state of the puncture apparatus  1 . 
     As shown in  FIGS. 47A to 47E , the support unit  17  can include a pinion gear  171  which is fixedly provided on the shaft portion  73  and rotated together with the shaft portion  73  and a first rack  172 C and a second rack  172 D which are fixedly provided on a grasping portion  21  of a frame  2  and are disposed opposite to each other, with the pinion gear  171  interposed therebetween. The first rack  172 C and the second rack  172 D are disposed with slight deviation from each other along a moving direction of the pinion gear  171 . In addition, each of the first rack  172 C and the second rack  172 D is so formed that an overall length of a toothed portion of first rack  172 C and the second rack  172 D is equal to an overall length of teeth  1711  of the pinion gear  171 . The support unit  17  can assume a state in which the pinion gear  171  is in mesh with the first rack  172 C, as shown in  FIGS. 47A ,  47 B, and  47 E, and a state in which the pinion gear  171  is in mesh with the second rack  172 D, as shown in  FIGS. 47C and 47D . 
     By the support unit  17  configured as above, the puncture member  3 E is operated to sequentially perform a first puncture (a puncture depicted in  FIG. 39  through  FIG. 40 ), a second puncture (a puncture depicted in  FIG. 40  through  FIG. 44 ), and a first puncture (a puncture depicted in  FIG. 44  through  FIG. 45 ), which can help ensure that an orbital path described by a needle tip  351  of the puncture member  3 E is a target puncture route R, and, accordingly, the puncture member  3 E punctures a living body along the target puncture route R. 
     A method of using the puncture apparatus  1  (operation procedure) in this exemplary embodiment will be described below, referring to  FIGS. 39 to 47E . 
     As shown in  FIG. 39 , the puncture apparatus  1  is set in a mounted state, and the needle tip  351  is abutted on a body surface H at a right-hand inguinal region of a patient or a region in the vicinity thereof (first region). For example, in this instance, the support unit  17  is in a state as shown in  FIG. 47A . 
     Next, while grasping an interlock portion  23  of a frame  2  by one hand, for example, an interlock portion  72  of an operating member  7  is grasped by the other hand, and the operating member  7  is rotated clockwise, as shown in  FIG. 40 . This causes the needle tip  351  of the puncture member  3 E to puncture the body surface H at the right-hand inguinal region of the patient or the region in the vicinity thereof (the first region), by the first puncture, thereby entering the body and reaching an obturator foramen  1101 . 
     As the rotating operation on the operating member  7  is further continued, as shown in  FIG. 41 , transition to the second puncture takes place, and puncturing by the second puncture is conducted. For example, in this instance, the support unit  17  is in a state as shown in  FIG. 47B . 
     Then, when a turning angle of the operating member  7  as measured from the state shown in  FIG. 39  reaches 45 degrees, as shown in  FIG. 42 , the needle tip  351  crosses a region between a urethra  1300  and a vagina  1400 . For example, in this instance, the support unit  17  is in a state as shown in  FIG. 47C , for example, the pinion gear  171  comes out of mesh with the first rack  172 C and meshes with the second rack  172 D. 
     Up to this point is a puncture route that is obtained in a forward course (like an outward journey). 
     Thereafter, as the rotating operation is continued further, as shown in  FIGS. 43 and 44 , the living body can be punctured by the second puncture until immediately before the needle tip  351  crosses an obturator foramen  1102 . For example, in this instance, the support unit  17  is in a state as shown in  FIG. 47D . 
     The shaft portion  73  can be moved vertically upward, the puncture member  3 E can also be moved in the same direction. This results in that the puncture member  3 E lifts up the urethra  1300  together with a urethral insertion member  4 , as shown in  FIG. 44 . 
     When the turning angle of the operating member  7  as measured from the state shown in  FIG. 39  reaches 90 degrees, as shown in  FIG. 45 , the needle tip  351  has crossed the obturator foramen  1102 , and further reaches a point immediately beneath the body surface H at a left-hand inguinal region or a region in the vicinity of the left-hand inguinal region. 
     Then, as the rotating operation on the operating member  7  is further continued, as shown in  FIG. 46 , the needle tip  351  protrudes from the body surface H to the outside of the body. For example, in this instance, the support unit  17  is in a state as shown in  FIG. 47E . 
     Up to this point is a puncture route obtained by a return course (like a return journey). 
     By the puncturing operation as above, a puncture hole in a bow-like shape can be formed in the living body proximate to the target puncture route R. This puncture hole also is in the state of reliably passing between the urethra  1300  and the vagina  1400 , like that in the first exemplary embodiment disclosed above. Thus, by the puncture apparatus  1  in this exemplary embodiment, also, puncturing a biological tissue can be carried out accurately. 
       FIGS. 48A and 48B  are sectional views showing an eighth embodiment of the puncture apparatus according to the present disclosure. 
     Now, referring to this figure, the eighth embodiment of the puncture apparatus and puncturing method according to the present disclosure will be described below. The following description will center on differences from the above-described embodiments, and descriptions of the same items as those mentioned above will be omitted. 
     This exemplary embodiment is the same as the first embodiment, except for a difference in a configuration of a restriction member. 
     As shown in  FIGS. 48A and 48B , in this exemplary embodiment, a restriction member  13  has a flange portion  132  which is so provided that it can be moved along an axial direction of the restriction member  13  and can be stopped at the moved position, through screw engagement, which can help ensure that a depth of puncture of the restriction member  13  into a living body of a patient can be regulated, thereby changing a distance of a first puncture applied to the living body, according to the body type of the patient. For instance, in a case of a somewhat large patient, the first puncture can be performed with the restriction member  13  set in a state as shown in  FIG. 48A . In a case of a slim-type patient, on the other hand, the first puncture can be conducted with the restriction member  13  set in a state as shown in  FIG. 48B . 
     While the flange portion  132  can be moved along the axial direction of the restriction member  13  and be stopped at the moved position through screw engagement as above-mentioned, for example, it can be preferable to provide a nut  134  maintaining the stopped state. After the flange portion  132  is stopped, the nut  134  is tightened from above the flange portion  132 , whereby the stopped condition of the flange portion  132  can be maintained. In addition, untightening the nut  134  results in that the flange portion  132  is movable. 
       FIGS. 49 and 50  are views showing the puncture member possessed by a puncture apparatus in accordance with a ninth exemplary embodiment of the present disclosure. Now, referring to these figures, the ninth embodiment of the present disclosure will be described below. This exemplary embodiment is the same as the fifth exemplary embodiment above, except for a difference in a configuration of a puncture member. 
     As shown in  FIG. 49 , in this exemplary embodiment, there is adopted a configuration that is obtained by omitting the needle body  35  from the puncture member  3 A in the fifth exemplary embodiment above. In addition, in a state (initial state) in which an insertion portion  71  is inserted in a puncture member  3 F, a distal portion  711  of the insertion portion  71  is protruding from a distal end opening of a main body  31  of a sheath  30 . The distal portion  711  protruding from the main body  31  functions also as a needle tip of the puncture member  3 F. With the distal portion  711  of the insertion portion  71  thus serving also as the needle body of the puncture member  3 F, it is enabled to reduce the number of component members, as compared with that in the above-described second embodiment, for example. In addition, when the puncture member  3 F is made to puncture a living body and the insertion portion  71  is pulled out of the puncture member  3 F, the distal end opening of the main body  31  can be opened. Specifically, according to this exemplary embodiment, the need for detaching the needle body  35  for opening the distal end opening of the main body  31 , as in the above-described fifth embodiment, is eliminated, so that the surgical operation can be carried out smoothly. In addition, for example, since the outside diameter of the insertion portion  71  and the inside diameter of the distal end opening of the main body  31  are set to be approximately equal to each other, positional deviation of the insertion portion  71  from the main body  31  is prevented, and operability is enhanced. 
     In addition, the main body  31  is provided at its distal portion with a tapered portion  319  where the outside diameter gradually increases along the proximal direction from the distal end opening. The tapered portion  319  functions as a dissection portion dissecting a living body in the manner of gradually expanding the living body, following the distal portion  711 , as the distal portion  711  of the insertion portion  71  punctures the living body. 
     A taper angle of the tapered portion  319  and a taper angle of the distal portion  711  may be equal to each other, but are preferably different from each other, as shown in  FIG. 49 . For example, in this case, the taper angle of the tapered portion  319  is smaller than the taper angle of the distal portion  711 , which helps enable smooth puncturing. 
     According to the ninth exemplary embodiment as above, also, an effect equivalent to that obtained in the aforementioned fifth exemplary embodiment can be produced. 
     Besides, as a modification of this exemplary embodiment, the following configuration may be mentioned. As shown in  FIG. 50 , a puncture member  3 F has a configuration obtained by omitting the needle body  35  from the puncture member  3 A from the above-described fifth exemplary embodiment. In addition, in a state (initial state) in which the insertion portion  71  is inserted in the puncture member  3 F, the distal portion  711  of the insertion portion  71  is protruding from a distal end opening of the main body  31 . 
     The distal portion  711  is detachably attached to the insertion portion  71 , by screw engagement, fitting or the like. The distal portion  711  has a needle tip  712  which protrudes from the distal end of the sheath  30 . The needle tip  712  is in a flat shape, modeled after the sheath  30 . The needle tip  712  can include a gradually increasing area portion  712   a  where cross-sectional area gradually increases along the distal direction; and a gradually decreasing area portion  712   b  where the cross-sectional area gradually decreases along the distal direction. The gradually decreasing area portion  712   b  is provided in the distal end of the gradually increasing area portion  712   a . A minor axis of a boundary portion  712   c  between the gradually increasing area portion  712   a  and the gradually decreasing area portion  712   b  is longer than a minor axis of the distal end of the sheath  30 , and a major axis of the boundary portion  712   c  is longer than a major axis of the distal end of the sheath  30 . This can help ensure that the inside of a living body can be punctured substantially by only the needle tip  712 . Accordingly, resistance to puncture can be reduced, and puncturing of a living body can be carried out smoothly. For example, the minor axis of the boundary portion  712   c  may be equal to the minor axis of the distal end of the sheath  30 , and the major axis of the boundary portion  712   c  may be equal to the major axis of the distal end of the sheath  30 . 
     While the puncture apparatus and puncturing method according to the present disclosure have been described above referring to the embodiments illustrated in the drawings, the disclosure is not restricted to the above embodiments. Each of the components of the puncture apparatus can be replaced by a component having such a configuration as to be able to exhibit an equivalent function. Besides, the puncture apparatus may have an arbitrary structure or structures added thereto, and the puncturing method may have an arbitrary step or steps added thereto. 
     In addition, the puncture apparatus and puncturing method according to the present disclosure may be a combination of arbitrary two or more of the configurations (characteristic features) adopted in the aforementioned embodiments. 
     Besides, while the needle body is detachably held on the main body of the sheath in the fifth embodiment above, this configuration is not restrictive. For instance, a configuration in which the needle body is fixed to the main body, such as a configuration wherein the main body and the needle body are integrally formed, may also be adopted. In that case, after a living body is punctured by the puncture member and the needle body is made to protrude to the outside of the living body, the needle body may be cut by use of a pair of scissors or the like, whereby the distal end opening of the main body can be opened. 
     While a configuration in which the main body of the sheath can be separated into a distal split piece and a proximal split piece has been described in the fifth exemplary embodiment above, this main body configuration is not restrictive. A configuration in which a distal end portion and a proximal end portion of the main body are not separable from each other may also be adopted. Specifically, the main body may be configured to be a single tube. In that case, the aforementioned state-maintaining mechanism is also omitted. 
     In addition, while a configuration in which the implant main body is inserted into the puncture member after the puncture member is placed in the inside of a living body has been described in the above embodiments, this configuration is not restrictive. The implant main body may be accommodated in the puncture member, from the beginning. In that case, it can be preferable, for example, for the implant main body to be set fixed relative to the needle tip. 
     In accordance with an exemplary embodiment, the puncture apparatus of the present disclosure is applied to an apparatus to be used in embedding in a living body an embeddable implant for treatment of female urinary incontinence has been disclosed in the above exemplary embodiments, this is not restrictive of the use of the puncture apparatus. 
     Examples of the object to which the present disclosure is applicable include pelvic floor diseases inclusive of excretory disorders (urinary urgency, frequent urination, urinary incontinence, fecal incontinence, urinary retention, dysuria, etc.), pelvic organ prolapse, vesicovaginal fistula, urethrovaginal fistula, and pelvic pain, which would be attendant on weakening of the group of pelvic floor muscles. The pelvic organ prolapse include such diseases as cystocele, enterocele, rectocele, and hysterocele, or such diseases as anterior vaginal prolapse, posterior vaginal prolapse, vaginal apical prolapse, and vaginal vault prolapse, which are denominations based on classification of the vaginal wall part being prolapsed. 
     In addition, examples of overactive tissue include the bladder, vagina, uterus, and bowels. On the other hand, examples of lessactive tissue include bones, muscles, fascias, and ligaments. Especially in relation to the pelvic floor diseases, examples of the lessactive tissue include obturator fascia, coccygeus fascia, cardinal ligament, uterosacral ligament, and sacrospinous ligament. 
     Examples of the procedure interlocking an overactive tissue in the pelvic floor disorder with the lessactive tissue, there are included a retropubi sling surgery, a transobturator sling surgery (Transobturator Sling Surgery; Transobturator Tape: TOT), a tension-free vaginal mesh (Tension-free Vaginal Mesh: TVM) surgery, a uterosacral ligament suspension (Uterosacral Ligament Suspension: USLS) surgery, an iliococcygeus fascia fixation surgery, and a coccygeus fascia fixation surgery. 
     The detailed description above describes puncture apparatus and puncturing method. The disclosure is not limited, however, to the precise embodiments and variations described. Various changes, modifications and equivalents can effected by one skilled in the art without departing from the spirit and scope of the disclosure as defined in the accompanying claims. It is expressly intended that all such changes, modifications and equivalents which fall within the scope of the claims are embraced by the claims.