Patent Publication Number: US-2015073465-A1

Title: Puncture apparatus

Description:
CROSS REFERENCES TO RELATED APPLICATIONS 
     This application is a continuation of International Application No. PCT/JP2013/063998 filed on May 21, 2013, and claims priority to Japanese Application No. 2012-118036 filed on May 23, 2012, the entire content of both of which is incorporated herein by reference. 
    
    
     TECHNICAL FIELD 
     The present disclosure relates to puncture apparatus. 
     BACKGROUND DISCUSSION 
     If a person suffers from urinary incontinence, for example, stress urinary incontinence, urine leakage is caused by application of abdominal pressure in normal exercise or due to laughing, coughing, sneezing, or the like. As a cause of this, for example, loosening of the pelvic floor muscle, which is a muscle that supports the urethra, because of childbirth or the like is cited. 
     Surgical therapy is effective for treatment of the urinary incontinence. For example, a tape-shaped implant called a “sling” is used. The sling is indwelled inside a body and the urethra is supported by the sling (refer to for example, Japanese Patent Laid-open No. 2010-99499). To indwell the sling inside the body, an operator incises the vagina with a surgical knife and dissects a region between the urethra and the vagina. Then, the operator makes the dissected region communicate with the outside through an obturator foramen of the pelvis to form a puncture hole by using a puncture needle. This formation of the puncture hole by the puncture needle is performed by blind operation based only on the sense of fingers. Then, the sling is indwelled inside the body by using such a puncture hole. 
     However, the method in which the sling is indwelled by using a conventional medical device such as the surgical knife can involve a defect that the invasion can be relatively great and burdensome on the patient. Furthermore, when the vagina is incised with the surgical knife and a region between the urethra and the vagina is dissected, the dissection can be performed in a wrong direction, and the sling cannot be indwelled at a proper position, such that the urethra can be damaged. The fingertip of the operator can also be damaged. In addition, the puncture route of the puncture needle can deviate from the target route in the formation of the puncture hole by the puncture needle due to the movement of the patient or the like such that the operator may be unaware of this in some cases. This can cause the urethra to be damaged, the sling may not be indwelled at a proper position, and the occurrence of a complication called “erosion” in which the sling breaks the vaginal wall to be exposed to the inside of the vagina after the operation, or the like can occur. 
     SUMMARY 
     In accordance with an exemplary embodiment, a puncture apparatus is disclosed that can prevent the region that must not be punctured from being punctured when living body tissues are punctured by a puncture needle, and can provide a relatively light burden on a patient with relatively high safety of the patient and operator. 
     In accordance with an exemplary embodiment, a puncture apparatus is disclosed, which can include an insertion portion that is insertable into a living body, a puncture needle that punctures living body tissues near the insertion portion in a state in which the insertion portion is inserted into the living body, and detection means that detects information relating to a positional relationship between a distal portion of the puncture needle and the insertion portion. 
     In accordance with an exemplary embodiment, in the puncture apparatus of the present disclosure, it can be preferable that the insertion portion is a urethral-insertion portion that is inserted into a urethra and has an elongated shape or a vaginal-insertion portion that is inserted into a vagina and has an elongated shape. 
     In accordance with an exemplary embodiment, in the puncture apparatus of the present disclosure, it can be preferable that the insertion portion is a urethral-insertion portion that is inserted into a urethra and has an elongated shape, and the puncture apparatus has a restriction unit that is provided on the urethral-insertion portion and restricts the position of the urethral-insertion portion in the longitudinal direction in the urethra. 
     In accordance with an exemplary embodiment, in the puncture apparatus of the present disclosure, it can be preferable that the detection means has a function to detect each of pieces of information relating to positional relationships between the distal portion of the puncture needle and two different regions of the insertion portion in the longitudinal direction. 
     In accordance with an exemplary embodiment, in the puncture apparatus of the present disclosure, it can be preferable that the puncture apparatus has two insertion portions as the insertion portion. 
     In accordance with an exemplary embodiment, in the puncture apparatus of the present disclosure, it can be preferable that one of the two insertion portions is a urethral-insertion portion that is inserted into a urethra and has an elongated shape, and the other is a vaginal-insertion portion that is inserted into a vagina and has an elongated shape. 
     In accordance with an exemplary embodiment, in the puncture apparatus of the present disclosure, it can be preferable that the detection means has a function to detect each of pieces of information relating to positional relationships between the distal portion of the puncture needle and two different regions of the insertion portion in the longitudinal direction. 
     In accordance with an exemplary embodiment, in the puncture apparatus of the present disclosure, it can be preferable that the detection means has a function to detect information relating to a positional relationship between one and the other of the two insertion portions. 
     In accordance with an exemplary embodiment, in the puncture apparatus of the present disclosure, it can be preferable that the puncture apparatus has informing means that informs information based on a detection result of the detection means. 
     In accordance with an exemplary embodiment, in the puncture apparatus of the present disclosure, it can be preferable that the puncture apparatus has determination means that determines whether or not the separated distance between the one and the other is equal to or larger than a minimum value of an allowable range, and an alarm is made by the informing means if it is determined by the determination means that the separated distance between the one and the other is smaller than the minimum value of the allowable range. 
     In accordance with an exemplary embodiment, in the puncture apparatus of the present disclosure, it can be preferable that the determination means has a function to determine whether or not the separated distance between the one and the other is equal to or smaller than a maximum value of an allowable range, and an alarm is made by the informing means if it is determined by the determination means that the separated distance between the one and the other is larger than the maximum value of the allowable range. 
     In accordance with an exemplary embodiment, in the puncture apparatus of the present disclosure, it can be preferable that the puncture apparatus has informing means that informs information based on a detection result of the detection means. 
     In accordance with an exemplary embodiment, in the puncture apparatus of the present disclosure, it can be preferable that the puncture apparatus has determination means that determines whether or not the separated distance between the distal portion of the puncture needle and the insertion portion is equal to or larger than a minimum value of an allowable range, and an alarm is made by the informing means if it is determined by the determination means that the separated distance between the distal portion of the puncture needle and the insertion portion is smaller than the minimum value of the allowable range. 
     In accordance with an exemplary embodiment, in the puncture apparatus of the present disclosure, it can be preferable that the puncture apparatus has determination means that determines whether or not the separated distance between the distal portion of the puncture needle and the insertion portion is equal to or smaller than a maximum value of an allowable range, and an alarm is made by the informing means if it is determined by the determination means that the separated distance between the distal portion of the puncture needle and the insertion portion is larger than the maximum value of the allowable range. 
     In accordance with an exemplary embodiment, in the puncture apparatus of the present disclosure, it can be preferable that the puncture apparatus has informing means that informs information based on a detection result of the detection means, and comparison means that compares one of the separated distances between the distal portion of the puncture needle and the two different regions of the insertion portion in the longitudinal direction with the other, and the informing means informs information based on a comparison result of the comparison means. 
     In accordance with an exemplary embodiment, in the puncture apparatus of the present disclosure, it can be preferable that the puncture needle is curved into a shape of a circular arc, and the puncture apparatus has a support portion that supports the puncture needle rotationally movably around a center axis of the circular arc, and a guide portion that is provided at a different position from the support portion and is located in a direction toward which a needle tip of the puncture needle moves when the puncture needle rotationally moves. 
     In accordance with an exemplary embodiment, in the puncture apparatus of the present disclosure, it can be preferable that the puncture needle is formed of a puncture needle assembly that includes an outer tube that is formed of a tubular body curved into a shape of a circular arc and has a one-end opening obtained by opening of one end of the outer tube and a needle body that is freely detachably mounted at the one-end opening and has a rounded, non-sharp needle tip to puncture living body tissues, the puncture needle assembly being capable of taking an assembled state in which the puncture needle assembly is assembled by mounting the needle body at the one-end opening, and the puncture apparatus has a support portion that supports the puncture needle assembly in the assembled state rotationally movably around a center axis of the circular arc of the outer tube, and a guide portion that is provided at a different position from the support portion and is located in a direction toward which the needle tip moves when the puncture needle assembly rotationally moves. 
     In accordance with an exemplary embodiment, according to the present disclosure, the region that must not be punctured can be prevented from being punctured when living body tissues are punctured by the puncture needle. In addition, the burden on the patient can be relatively light and the safety of the patient can be relatively high. Furthermore, the safety of the operator can also be relatively high. 
     For example, when the puncture apparatus of the present disclosure is used for treatment of urinary incontinence of a woman, the insertion portion of the puncture apparatus is inserted into a urethra and the puncture needle is rotationally moved to puncture the living body by the puncture needle. At this time, information relating to the positional relationship between the distal portion of the puncture needle and the insertion portion can be detected and thus puncture of the urethra by the puncture needle can be prevented. 
     Furthermore, in implanting an implant for treatment of urinary incontinence, incision of the vaginal wall is unnecessary and the implant can be implanted by a less-invasive procedure. Moreover, damage to a fingertip to the operator can be prevented. 
     In accordance with an exemplary embodiment, a puncture apparatus is disclosed comprising: an insertion portion that is insertable into a living body; a puncture needle that punctures living body tissues near the insertion portion in a state in which the insertion portion is inserted into the living body; and detection means that detects information relating to a positional relationship between a distal portion of the puncture needle and the insertion portion. 
     In accordance with an exemplary embodiment, a puncture apparatus is disclosed comprising: a puncture needle that punctures living body tissues near the insertion portion in a state in which the insertion portion is inserted into the living body, the puncture needle having at least one ultrasonic sensor on a distal portion of the puncture needle; an insertion portion that is insertable into a living body, the insertion portion comprising at least one of a urethral-insertion portion that is inserted into a urethra and has an elongated shape and a vaginal-insertion portion that is inserted into a vagina and has an elongated shape, the insertion portion having at least one reflective portion that reflects ultrasound; and detection means that detects information relating to a positional relationship between the distal portion of the puncture needle and the insertion portion based on the at least one ultrasonic sensor on the puncture needle and the at least one reflective portion on the insertion portion. 
     In accordance with an exemplary embodiment, a method of preventing a region of a living body from being punctured is disclosed, comprising: inserting an insertion portion into a living body, the insertion portion comprising at least one of a urethral-insertion portion that is inserted into a urethra and has an elongated shape and a vaginal-insertion portion that is inserted into a vagina and has an elongated shape; inserting a puncture needle that punctures living body tissues near the insertion portion in a state in which the insertion portion is inserted into the living body; detecting a positional relationship between a distal portion of the puncture needle and the insertion portion; and informing an operator of the positional relationship between the distal portion of the puncture needle and the insertion portion using an informing means. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a partial sectional view illustrating a first exemplary embodiment of a puncture apparatus of the present disclosure. 
         FIGS. 2A-2D  are diagrams illustrating the puncture apparatus illustrated in  FIG. 1 , wherein  FIG. 2A  is a side view,  FIG. 2B  is a front view,  FIG. 2C  is a back view, and  FIG. 2D  is a sectional view along line A-A in  FIG. 2A . 
         FIG. 3  is a block diagram illustrating the circuit configuration of the puncture apparatus illustrated in  FIG. 1 . 
         FIG. 4  is a flowchart illustrating control operation of a control unit of the puncture apparatus illustrated in  FIG. 1 . 
         FIG. 5  is a diagram for explaining a step of a procedure when the puncture apparatus illustrated in  FIG. 1  is used. 
         FIG. 6  is a diagram for explaining a step of the procedure when the puncture apparatus illustrated in  FIG. 1  is used. 
         FIG. 7  is a diagram for explaining a step of the procedure when the puncture apparatus illustrated in  FIG. 1  is used. 
         FIG. 8  is a diagram for explaining a step of the procedure when the puncture apparatus illustrated in  FIG. 1  is used. 
         FIG. 9  is a diagram for explaining a step of the procedure when the puncture apparatus illustrated in  FIG. 1  is used. 
         FIG. 10  is a diagram for explaining a step of the procedure when the puncture apparatus illustrated in  FIG. 1  is used. 
         FIG. 11  is a diagram for explaining a step of the procedure when the puncture apparatus illustrated in  FIG. 1  is used. 
         FIG. 12  is a diagram for explaining a step of the procedure when the puncture apparatus illustrated in  FIG. 1  is used. 
         FIG. 13  is a partial sectional view illustrating a second exemplary embodiment of the puncture apparatus of the present disclosure. 
         FIGS. 14A-14C  are diagrams illustrating the puncture apparatus illustrated in  FIG. 13 . 
         FIG. 15  is a block diagram illustrating the circuit configuration of the puncture apparatus illustrated in  FIG. 13 . 
         FIG. 16  is a flowchart illustrating control operation of a control unit of the puncture apparatus illustrated in  FIG. 13 . 
         FIG. 17  is a diagram for explaining a step of a procedure when the puncture apparatus illustrated in  FIG. 13  is used. 
         FIG. 18  is a diagram for explaining a step of the procedure when the puncture apparatus illustrated in  FIG. 13  is used. 
         FIG. 19  is a diagram for explaining a step of the procedure when the puncture apparatus illustrated in  FIG. 13  is used. 
         FIG. 20  is a diagram for explaining a step of the procedure when the puncture apparatus illustrated in  FIG. 13  is used. 
         FIG. 21  is a diagram for explaining a step of the procedure when the puncture apparatus illustrated in  FIG. 13  is used. 
         FIG. 22  is a diagram for explaining a step of the procedure when the puncture apparatus illustrated in  FIG. 13  is used. 
         FIG. 23  is a diagram for explaining a step of the procedure when the puncture apparatus illustrated in  FIG. 13  is used. 
         FIG. 24  is a diagram for explaining a step of the procedure when the puncture apparatus illustrated in  FIG. 13  is used. 
         FIGS. 25A-25C  are diagrams illustrating a third exemplary embodiment of the puncture apparatus of the present disclosure, wherein  FIG. 25A  is a side view,  FIG. 25B  is a front view, and  FIG. 25C  is a back view. 
         FIG. 26  is a block diagram illustrating the circuit configuration of the puncture apparatus illustrated in  FIG. 25 . 
         FIG. 27  is a flowchart illustrating control operation of a control unit of the puncture apparatus illustrated in  FIG. 25 . 
         FIGS. 28A-28C  are partial sectional views illustrating a fourth exemplary embodiment of the puncture apparatus of the present disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     In the following, description will be so made that the left side is defined as the “distal end” and the right side is defined as the “proximal end” along the longitudinal direction of a puncture needle assembly in  FIG. 1  and the lower side is defined as the “distal end” and the upper side is defined as the “proximal end” along the longitudinal direction of a vaginal-insertion portion and a urethral-insertion portion in  FIGS. 2A ,  2 B, and  2 C. 
     Furthermore, in each of  FIGS. 5 to 12 , for high visibility, each ultrasonic sensor and each reflective portion are represented with a large size schematically and slant lines in the living body are omitted. 
     In accordance with an exemplary embodiment, a puncture apparatus  1  as illustrated in these diagrams can be used for treatment of urinary incontinence of a woman, for example, used when an implant (in-vivo indwelling device) for treatment of urinary incontinence is implanted in a living body. 
     As illustrated in  FIGS. 1 to 3 , the puncture apparatus  1  includes first apparatus  11 , second apparatus  12 , and an apparatus main body  13 . 
     As illustrated in  FIG. 1 , the first apparatus  11  includes a puncture needle assembly  9  and a support member  10  as a puncture needle. 
     The puncture needle assembly  9  can be curved into a circular arc shape. This puncture needle assembly  9  can include an outer tube  91  formed of a tubular body curved into a circular arc shape and an inside structural body  94  composed of a needle body  92  and an implant  93 . Furthermore, the puncture needle assembly  9  can take an assembled state in which the outer tube  91  and the inside structural body  94  are assembled (see  FIGS. 1 and 6  to  9 ) and a decomposed state in which the outer tube  91  and the inside structural body  94  are separated from the assembled state (see  FIGS. 10 to 12 ). Moreover, the puncture needle assembly  9  punctures, in the assembled state, living body tissues near a urethral-insertion portion  31  and a vaginal-insertion portion  2  to be described later, for example, between the urethral-insertion portion  31  and the vaginal-insertion portion  2 , in a state in which the urethral-insertion portion  31  and the vaginal-insertion portion  2  are inserted into a urethra and a vagina, respectively. 
     The outer tube  91  has an one-end opening  911  obtained by opening of one end of the outer tube  91  and has a grasping unit  912  at the other end portion. The needle body  92  can be freely detachably mounted at the one-end opening  911 . Furthermore, the grasping unit  912  serves as a portion grasped when the outer tube  91  is drawn out from living body tissues as described later. 
     In accordance with an exemplary embodiment, the central angle of the outer tube  91  forming a circular arc shape, for example, is about 135 to 210°, and for example, preferable that the central angle is about 150 to 180°. 
     The needle body  92  can form a mushroom shape and its top portion can serve as a needle tip  921  that can puncture living body tissues. The needle tip  921  may be somewhat rounded so that an operator may be prevented from accidentally puncturing an operator&#39;s own finger or the like. Furthermore, a step portion  922  at which the outer diameter steeply changes is formed at the proximal portion of the needle body  92 , for example, a portion on the opposite side to the needle tip  921 . 
     The implant  93  is an implantable device for treatment of urinary incontinence of a woman and can be an elongated member interlocked with the proximal portion of the needle body  92 . This implant  93  forms a mesh shape and has flexibility. The implant  93  is indwelled in living body tissues together with the needle body  92  and supports the urethra. When the urethra tries to move toward the vaginal wall for example, the implant  93  supports the urethra in such a manner as to draw the urethra in the direction in which the urethra gets farther away from the vaginal wall. 
     Furthermore, in the assembled state, the needle body  92  is mounted at the one-end opening  911  of the outer tube  91  and the implant  93  is inserted in the outer tube  91 . In the decomposed state, the needle body  92  separates from the one-end opening  911  of the outer tube  91  and the implant  93  is withdrawn from the outer tube  91 . 
     The constituent material of the outer tube  91  is not particularly limited. For example, metal materials such as stainless steel, aluminum or aluminum alloy, and titanium or titanium alloy can be used. Furthermore, the constituent material of the needle body  92  and the implant  93  is not particularly limited. For example, various kinds of resin materials having biocompatibility, such as polypropylene, fiber, and so forth can be used. 
     Furthermore, two ultrasonic sensors (ultrasonic oscillators)  71  and  72  that transmit and receive ultrasound are placed at the distal portion of the puncture needle assembly  9 , for example, on the outer circumferential surface of the distal portion of the outer tube  91 . The ultrasonic sensor  71  is a component that transmits/receives ultrasound to/from a reflective portion  36  of the urethral-insertion portion  31  to be described later, for example, a component that transmits ultrasound to the reflective portion  36  and receives ultrasound reflected by the reflective portion  36 . In addition, the ultrasonic sensor  72  is a component that transmits/receives ultrasound to/from a reflective portion  21  of the vaginal-insertion portion  2  to be described later, for example, a component that transmits ultrasound to the reflective portion  21  and receives ultrasound reflected by the reflective portion  21 . These ultrasonic sensors  71  and  72  each have, for example, an ultrasonic oscillator made by forming electrodes on both surfaces of a piezoelectric body composed of PZT (lead zirconate titanate) or the like. 
     The ultrasonic sensor  71  is disposed on the inner circumferential side of the circular arc as the curved shape of the puncture needle assembly  9  so as to be located on the side of the urethral-insertion portion  31  when living body tissues are punctured by the puncture needle assembly  9 . 
     Furthermore, it can be preferable that the ultrasonic sensor  71  is so placed that an angle θ1 formed by the center line of ultrasound transmitted from the ultrasonic sensor  71  and a tangent to the outer tube  91  at the site where the ultrasonic sensor  71  is placed is, for example, about 15° to 75°, and it can be more preferable that the ultrasonic sensor  71  is so set that the angle θ1 is, for example, about 30° to 60°. In accordance with an exemplary embodiment, θ1 is set to 45° in the configuration illustrated in the diagram. 
     Meanwhile, the ultrasonic sensor  72  is disposed on the outer circumferential side of the circular arc as the curved shape of the puncture needle assembly  9  so as to be located on the side of the vaginal-insertion portion  2  when living body tissues are punctured by the puncture needle assembly  9 . 
     Furthermore, it can be preferable that the ultrasonic sensor  72  is so placed that an angle  82  formed by the center line of ultrasound transmitted from the ultrasonic sensor  72  and a tangent to the outer tube  91  at the site where the ultrasonic sensor  72  is placed is, for example, about 15° to 75°, and it can be more preferable that the ultrasonic sensor  72  is so set that the angle  82  is, for example, about 30° to 60°. In accordance with an exemplary embodiment, θ2 is set to 45° in the configuration illustrated in the diagram. 
     In accordance with an exemplary embodiment the number of ultrasonic sensors is not limited to two and may be, for example, one, or three or more. 
     The support member  10  has a support portion  101 , a guide portion  102  disposed at a different position from the support portion  101 , for example, disposed separately from the support portion  101 , and an interlock portion  103  that interlocks the support portion  101  with the guide portion  102 . 
     The support portion  101  is a member that is formed of a block body of a cuboid or cube and in which a through-hole  104  penetrating the block body is formed. The puncture needle assembly  9  (outer tube  91 ) in the assembled state is insertable into the through-hole  104  and the through-hole  104  is curved with a curvature equivalent to that of the outer tube  91  (puncture needle assembly  9 ). Furthermore, by this through-hole  104 , the puncture needle assembly  9  in the assembled state is supported rotationally movably around an axis whose center axis is the center O of the circular arc of the outer tube  91  (see  FIGS. 6 to 9 ). 
     Furthermore, a surface  105  of the support portion  101  on the lower side in  FIG. 1  functions as a put portion put on a body surface. In accordance with an exemplary embodiment, the support portion  101  is not limited to the block body and may have, for example, a shape including a curved surface. 
     The guide portion  102  is a member that is formed of a block body of a cuboid or cube and is located in the direction toward which the needle tip  921  of the needle body  92  moves when the puncture needle assembly  9  in the assembled state rotationally moves. In the present embodiment, the needle tip  921  of the needle body  92  is supposed to move toward the center portion of the guide portion  102 . 
     A surface  106  of the guide portion  102  on the lower side in  FIG. 1 , for example, a surface to face the needle tip  921 , functions as a put portion put on a body surface. In accordance with an exemplary embodiment, the guide portion  102  is not limited to the block body and may have for example, a shape including a curved surface. 
     A reflective portion  107  that reflects ultrasound is provided on the surface  106  of the guide portion  102 . The position of this reflective portion  107  is not particularly limited. In the present exemplary embodiment, the reflective portion  107  can be disposed at such a position that the center axis of ultrasound transmitted from the ultrasonic sensor  71  penetrates the reflective portion  107  when living body tissues are punctured by the puncture needle assembly  9  and the needle tip  921  of the puncture needle assembly  9  is brought close to the reflective portion  107 , for example, at an end portion of the guide portion  102  on the interlock portion side. 
     Furthermore, the reflective portion  107  is not particularly limited as long as it can reflect ultrasound. For example, as its constituent material, an object obtained by using a metal material such as stainless steel, aluminum or aluminum alloy, or titanium or titanium alloy and forming plural minute concavities and convexities on a surface, and so forth can be used. In addition, if the guide portion  102  is composed of a metal material, plural minute concavities and convexities may be formed on a surface of the guide portion  102  as the reflective portion  107 . 
     The interlock portion  103  is formed of an elongated body and supports the support portion  101  and the guide portion  102  at its both end portions, respectively. Due to this, the support portion  101  is interlocked with the guide portion  102  via the interlock portion  103 . 
     Furthermore, in the puncture apparatus  1 , the puncture needle assembly  9  can be operated in a state in which the urethral-insertion portion  31  of the second apparatus  12  to be described later is inserted into a urethra and the vaginal-insertion portion  2  is inserted into a vagina, and the surface  105  of the support portion  101  is put on a body surface and the surface  106  of the guide portion  102  is put on the body surface (hereinafter, this state will be referred to as the “use state”) (see  FIGS. 5 to 12 ). In accordance with an exemplary embodiment, a puncture hole for implanting the implant  93  can be formed in living body tissues by rotationally moving the puncture needle assembly  9  with the center O of the circular arc of the outer tube  91  being the center of the rotary movement. 
     As illustrated in  FIG. 2 , the second apparatus  12  includes the vaginal-insertion portion (insertion portion)  2  that is inserted into a vagina and has an elongated shape, a urethral-insertion member  3  having the urethral-insertion portion (insertion portion)  31  that is inserted into a urethra and has an elongated shape, and an interlock portion  4  as interlock means that interlocks the vaginal-insertion portion  2  with the urethral-insertion member  3 . 
     The shape of the vaginal-insertion portion  2  is not particularly limited as long as it is an elongated shape. In the present exemplary embodiment, the vaginal-insertion portion  2  forms a plate shape. Furthermore, the width of the vaginal-insertion portion  2  gradually decreases in its distal direction and the thickness of the vaginal-insertion portion  2  gradually decreases in its distal direction. Furthermore, the distal portion of the vaginal-insertion portion  2  is rounded, which can help enhance the safety of the patient. 
     Moreover, the vaginal-insertion portion  2  is curved. Due to this, the operative field can be oriented toward the front side of the operator when the vaginal-insertion portion  2  is inserted into a vagina, so that the operative field can be set wide. 
     The urethral-insertion member  3  has the urethral-insertion portion  31  and a protrusion  32  that is formed at the proximal portion of the urethral-insertion portion  31  and protrudes from the urethral-insertion portion  31  toward the left side in  FIG. 2A . 
     The shape of the urethral-insertion portion  31  is not particularly limited as long as it is an elongated shape. In the present exemplary embodiment, the urethral-insertion portion  31  forms a bar shape. Furthermore, the distal portion of the urethral-insertion portion  31  is rounded, which can help enhance the safety of the patient. 
     Moreover, the urethral-insertion portion  31  is curved in the same direction as the vaginal-insertion portion  2 . The curvature of this urethral-insertion portion  31  is set equal to that of the vaginal-insertion portion  2 . Furthermore, the posture of the urethral-insertion portion  31  is so set that the separated distance between the urethral-insertion portion  31  and the vaginal-insertion portion  2  is constant along the longitudinal direction of the urethral-insertion portion  31 . 
     The interlock portion  4  is fixed to the right side, in  FIG. 2(   a ), of the proximal portion of the vaginal-insertion portion  2 . 
     In this interlock portion  4 , a bottomed hole  41  is formed along the left-right direction in  FIGS. 2A and 2D . In accordance with an exemplary embodiment the right side of the hole  41  in  FIGS. 2A and 2D  is opened. 
     In the hole  41 , the protrusion  32  of the urethral-insertion member  3  is inserted movably in its longitudinal direction. By the movement of the urethral-insertion member  3  relative to the interlock portion  4  in the longitudinal direction of the protrusion  32 , the separated distance  35  between the vaginal-insertion portion  2  and the urethral-insertion portion  31  can be changed. Therefore, adjustment means that adjusts the separated distance  35  between the vaginal-insertion portion  2  and the urethral-insertion portion  31  is configured by the hole  41  of the interlock portion  4  and the protrusion  32  of the urethral-insertion member  3 . Because the patient involves individual difference and the separated distance between the vagina and the urethra often differs depending on the patient, the separated distance between the vaginal-insertion portion  2  and the urethral-insertion portion  31  can be appropriately adjusted to fit the patient by the adjustment means. 
     Furthermore, the second apparatus  12  has a male screw  51 , and a female screw portion  42  having a female screw screwed to the male screw  51  is formed in the interlock portion  4 . 
     When the male screw  51  is rotated in a predetermined direction, the distal end of the male screw  51  comes into pressure contact with the protrusion  32  of the urethral-insertion member  3  and the movement of the urethral-insertion member  3  relative to the interlock portion  4  is inhibited. Furthermore, when the male screw  51  is rotated in the opposite direction of the aforementioned direction, the distal end of the male screw  51  gets separated from the protrusion  32  and the movement of the urethral-insertion member  3  relative to the interlock portion  4  is allowed. 
     In accordance with an exemplary embodiment a locking portion that switches the state between the state in which the urethral-insertion member  3  can move relative to the interlock portion  4  and the state in which the movement of the urethral-insertion member  3  is inhibited is configured by the male screw  51  and the female screw portion  42 . 
     Furthermore, at the distal portion of the urethral-insertion portion  31 , an inflatable and deflatable balloon  61  is provided as a restriction unit that restricts the position of the urethral-insertion portion  31  in the longitudinal direction in a urethra. When the second apparatus  12  is used, the balloon  61  is inserted into the bladder of a patient and the balloon  61  catches on the bladder neck in the inflated state. The position of the urethral-insertion portion  31  relative to the bladder and the urethra can thereby be fixed. 
     Furthermore, a lumen  33  is formed in the urethral-insertion portion  31 . The distal end of this lumen  33  is opened in the balloon  61  and the proximal end is opened to a side surface of the proximal portion of the urethral-insertion portion  31 . In addition, a port  34  communicating with the proximal end of the lumen  33  can be formed at the proximal portion of the urethral-insertion portion  31 . 
     The balloon  61  is inflated or deflated by connecting a balloon inflation device such as a syringe not illustrated to the port  34  and sending a working fluid supplied from the balloon inflation device into the inside of the balloon  61  via the lumen  33  or drawing the working fluid. In accordance with an exemplary embodiment for example, a liquid such as a physiological saline solution, a gas, or the like can be used as the working fluid for the balloon inflation. 
     In accordance with an exemplary embodiment, the restriction unit to restrict the position of the urethral-insertion portion  31  in a urethra is not limited to the balloon  61 . For example, the urethral-insertion portion  31  that partially curves, an object that holds part of the urinary tract tissue surface, and so forth are also possible. 
     Furthermore, on the surface of the middle portion of the urethral-insertion portion  31  on the side of the vaginal-insertion portion  2 , the reflective portion  36  that reflects ultrasound transmitted from the ultrasonic sensor  71  is provided. 
     Furthermore, the reflective portion  36  is not particularly limited as long as it can reflect ultrasound. For example, as its constituent material, an object obtained by using a metal material such as stainless steel, aluminum or aluminum alloy, or titanium or titanium alloy and forming plural minute concavities and convexities on a surface, and so forth can be used. In addition, if the urethral-insertion portion  31  is composed of a metal material, plural minute concavities and convexities may be formed on a surface of the urethral-insertion portion  31  as the reflective portion  36 . 
     Moreover, on the surface of the middle portion of the vaginal-insertion portion  2  on the side of the urethral-insertion portion  31 , the reflective portion  21  that reflects ultrasound transmitted from the ultrasonic sensor  72  is provided. 
     Furthermore, the reflective portion  21  is not particularly limited as long as it can reflect ultrasound. For example, as its constituent material, an object obtained by using a metal material such as stainless steel, aluminum or aluminum alloy, or titanium or titanium alloy and forming plural minute concavities and convexities on a surface, and so forth can be used. In addition, if the vaginal-insertion portion  2  is composed of a metal material, plural minute concavities and convexities may be formed on a surface of the vaginal-insertion portion  2  as the reflective portion  21 . 
     In accordance with an exemplary embodiment, although the reflective portion  36  is provided on part of the surface of the urethral-insertion portion  31  in the present exemplary embodiment, the configuration is not limited thereto, and for example, the reflective portion  36  may be provided on the whole surface of the urethral-insertion portion  31 . In this case, the shortest distance between the urethral-insertion portion  31  and the site where the ultrasonic sensor  71  is placed on the puncture needle assembly  9  is detected by the ultrasonic sensor  71 . 
     Furthermore, although the reflective portion  21  is provided on part of the surface of the vaginal-insertion portion  2  in the present exemplary embodiment, the configuration is not limited thereto, and for example, the reflective portion  21  may be provided on the whole surface of the vaginal-insertion portion  2 . In this case, the shortest distance between the vaginal-insertion portion  2  and the site where the ultrasonic sensor  72  to be described later is placed on the puncture needle assembly  9  is detected by the ultrasonic sensor  72 . 
     As illustrated in  FIG. 3 , the apparatus main body  13  has a control unit  131 , an operation unit  132  to carry out respective operations, a display unit  133  as informing means, a buzzer  134  as informing means, and transmitting/receiving units  135  and  136  that perform signal transmission and reception to and from the ultrasonic sensors  71  and  72 . The transmitting/receiving units  135  and  136  of this apparatus main body  13  are electrically connected to the ultrasonic sensors  71  and  72 , respectively, via cables not illustrated. 
     The control unit  131  is formed of for example, a microcomputer or the like and accepts an input signal from the operation unit  132 . Furthermore, the control unit  131  carries out control of the whole of the puncture apparatus  1 , such as the display unit  133 , the buzzer  134 , and the transmitting/receiving units  135  and  136 . In accordance with an exemplary embodiment detection means that detects information relating to the positional relationship between the distal portion of the puncture needle assembly  9  and the urethral-insertion portion  31 , the vaginal-insertion portion  2 , and the guide portion  102  is configured by the control unit  131 , the transmitting/receiving units  135  and  136 , and the ultrasonic sensors  71  and  72 . Furthermore, determination means and comparison means are configured by the control unit  131 . 
     From the operation unit  132 , the respective inputs are made, such as measurement time ts, measurement interval Δt, maximum value Lvmax and minimum value Lvmin of the allowable range of separated distance Lv, and maximum value Lumax and minimum value Lumin of the allowable range of separated distance Lu. 
     The display unit  133  is not particularly limited, and, for example, liquid crystal display apparatus, CRT, can be used. 
     The transmitting/receiving units  135  and  136  transmit, to the ultrasonic sensors  71  and  72 , an electrical signal for transmitting ultrasound from the ultrasonic sensors  71  and  72 , respectively. Furthermore, when the ultrasonic sensors  71  and  72  receive ultrasound and an electrical signal is transmitted from the ultrasonic sensors  71  and  72 , the transmitting/receiving units  135  and  136  receive the signal. 
     In accordance with an exemplary embodiment, the puncture hole formed in living body tissues by puncturing the living body tissues by the puncture needle assembly  9  of the puncture apparatus  1  is a non-through-hole that penetrates the body surface on the side of the support member  10  of the first apparatus  11  and does not penetrate the body surface on the side of the guide portion  102  (see  FIGS. 9 and 10 ). In forming this puncture hole in the living body tissues, the puncture needle assembly  9  rotationally moves with the center O of the circular arc of the outer tube  91  being the center of the rotary movement, and the distal portion of the puncture needle assembly  9 , for example, the needle tip  921 , passes between the urethral-insertion portion  31  and the vaginal-insertion portion  2  (see  FIGS. 7 and 8 ). 
     Furthermore, in this puncture apparatus  1 , when living body tissues are punctured by the puncture needle assembly  9 , the control unit  131  carries out transmission and reception of ultrasound by the ultrasonic sensors  71  and  72  to thereby detect information relating to each of the positional relationship between the distal portion of the puncture needle assembly  9  and the urethral-insertion portion  31 , the positional relationship between the distal portion of the puncture needle assembly  9  and the vaginal-insertion portion  2 , and the positional relationship between the distal portion of the puncture needle assembly  9  and the guide portion  102  of the support member  10 . In accordance with an exemplary embodiment, because the urethral-insertion portion  31  is inserted into the urethra of a patient, the positional relationship between the distal portion of the puncture needle assembly  9  and the urethral-insertion portion  31  is equivalent to the positional relationship between the distal portion of the puncture needle assembly  9  and the urethral wall. Furthermore, because the vaginal-insertion portion  2  is inserted into the vagina of the patient, the positional relationship between the distal portion of the puncture needle assembly  9  and the vaginal-insertion portion  2  is equivalent to the positional relationship between the distal portion of the puncture needle assembly  9  and the vaginal wall. In addition, because the surface  106  of the guide portion  102  is placed on the body surface of the patient, the positional relationship between the distal portion of the puncture needle assembly  9  and the guide portion  102  is equivalent to the positional relationship between the distal portion of the puncture needle assembly  9  and the skin. 
     In accordance with an exemplary embodiment, the control unit  131  transmits ultrasound by the ultrasonic sensor  71 . This ultrasound reflects at the reflective portion  36  provided on the urethral-insertion portion  31  and is received by the ultrasonic sensor  71 . Then, the control unit  131  measures the time from the transmission of the ultrasound by the ultrasonic sensor  71  to the reception and obtains the separated distance Lu between the distal portion of the puncture needle assembly  9  and the urethral-insertion portion  31 . In accordance with an exemplary embodiment, the allowable range of the separated distance Lu, specifically the maximum value Lumax and the minimum value Lumin of the allowable range of the separated distance Lu, is set in advance. 
     The maximum value Lumax is not particularly limited and is appropriately set according to conditions. For example, it can be preferable that the maximum value Lumax is about 15 mm to 50 mm, and, for example, it can be more preferable that the maximum value Lumax is about 20 mm to 40 mm. 
     In addition, the minimum value Lumin is not particularly limited and is appropriately set according to conditions. For example, it can be preferable that the minimum value Lumin is about 1 mm to 10 mm, and, for example, it can be more preferable that the minimum value Lumin is about 3 mm to 8 mm. 
     Furthermore, the control unit  131  transmits ultrasound by the ultrasonic sensor  72 . This ultrasound reflects at the reflective portion  21  provided on the vaginal-insertion portion  2  and is received by the ultrasonic sensor  72 . Then, the control unit  131  measures the time from the transmission of the ultrasound by the ultrasonic sensor  72  to the reception and obtains the separated distance Lv between the distal portion of the puncture needle assembly  9  and the vaginal-insertion portion  2 . In accordance with an exemplary embodiment, the allowable range of the separated distance Lv, specifically the maximum value Lvmax and the minimum value Lvmin of the allowable range of the separated distance Lv, can be set in advance. 
     The maximum value Lvmax is not particularly limited and is appropriately set according to conditions. For example, it can be preferable that the maximum value Lvmax is about 15 mm to 50 mm, and, for example, it can be more preferable that the maximum value Lvmax is about 20 mm to 40 mm. 
     In addition, the minimum value Lvmin is not particularly limited and is appropriately set according to conditions. For example, it can be preferable that the minimum value Lvmin is about 1 mm to 10 mm, and, for example, it is more preferable that the minimum valve Lvmin is about 3 mm to 8 mm. 
     If these separated distances Lu and Lv are each in the allowable range, living body tissues can be properly punctured by the puncture needle assembly  9 . In this case, the distal portion of the puncture needle assembly  9 , for example, the needle tip  921 , passes between the urethral-insertion portion  31  and the vaginal-insertion portion  2  and can be prevented from puncturing the urethra and the vagina. 
     In accordance with an exemplary embodiment, the configuration can be made that, if the separated distances Lu and Lv are each in the allowable range, this status can be transmitted to the operator through no display is made on the display unit  133  and the buzzer  134  does not sound. However, the configuration is not limited thereto. For example, if the separated distances Lu and Lv are each in the allowable range, this status can be transmitted by making a predetermined displaying on the display unit  133 . 
     In accordance with an exemplary embodiment, if the separated distance Lu is out of the allowable range, specifically if the separated distance Lu is smaller than the minimum value Lumin of the allowable range, the distance between the distal portion of the puncture needle assembly  9  and the urethral-insertion portion  31 , for example, the distance between the distal portion of the puncture needle assembly  9  and the urethra, is too small, and there is a possibility that the urethra is punctured by the puncture needle assembly  9 . Thus, a predetermined alarm can be made by each of the display unit  133  and the buzzer  134 . Specifically, predetermined alarm information can be displayed on the display unit  133  and the buzzer  134  can be sounded, which can allow the operator to understand the situation and prevent the puncture needle assembly  9  from puncturing the urethra. 
     Furthermore, if the separated distance Lu is larger than the maximum value Lumax of the allowable range, the distance between the distal portion of the puncture needle assembly  9  and the urethral-insertion portion  31 , for example, the distance between the distal portion of the puncture needle assembly  9  and the urethra, is too large, and there is a possibility that the state is not the normal state. Thus, a predetermined alarm can be made by each of the display unit  133  and the buzzer  134 . Specifically, predetermined alarm information can be displayed on the display unit  133  and the buzzer  134  can be sounded, which can allow the operator to understand the situation and respond to it. 
     Moreover, if the separated distance Lv is out of the allowable range, specifically if the separated distance Lv is smaller than the minimum value Lvmin of the allowable range, the distance between the distal portion of the puncture needle assembly  9  and the vaginal-insertion portion  2 , for example, the distance between the distal portion of the puncture needle assembly  9  and the vagina, is too small, and there is a possibility that the vaginal wall is punctured by the puncture needle assembly  9 . Thus, a predetermined alarm can be made by each of the display unit  133  and the buzzer  134 . Specifically, predetermined alarm information can be displayed on the display unit  133  and the buzzer  134  can be sounded, which can allow the operator to understand the situation and prevent the puncture needle assembly  9  from puncturing the vaginal wall. 
     Furthermore, if the separated distance Lv is larger than the maximum value Lvmax of the allowable range, the distance between the distal portion of the puncture needle assembly  9  and the vaginal-insertion portion  2 , for example, the distance between the distal portion of the puncture needle assembly  9  and the vagina, is too large, and there is a possibility that the state is not the normal state. Thus, a predetermined alarm can be made by each of the display unit  133  and the buzzer  134 . Specifically, predetermined alarm information can be displayed on the display unit  133  and the buzzer  134  can be sounded, which can allow the operator to understand the situation and respond to it. 
     Furthermore, after the distal portion of the puncture needle assembly  9  has passed between the urethral-insertion portion  31  and the vaginal-insertion portion  2 , the control unit  131  continuously transmits ultrasound by the ultrasonic sensor  71 . This ultrasound reflects at the reflective portion  107  provided on the guide portion  102  of the support member  10  and is received by the ultrasonic sensor  71 . Then, the control unit  131  measures the time from the transmission of the ultrasound by the ultrasonic sensor  71  to the reception and obtains the separated distance Lw between the distal portion of the puncture needle assembly  9  and the guide portion  102 . The control unit  131  determines the timing when the values of the detected separated distances Lu and Lv become the minimum values after gradual decrease as the timing when the distal portion of the puncture needle assembly  9  is passing between the urethral-insertion portion  31  and the vaginal-insertion portion  2 . In accordance with an exemplary embodiment, a target value Lwp of the separated distance Lw is so set in advance that the needle tip  921  of the puncture needle assembly  9  comes close to, and does not reach, the surface  106  of the guide portion  102 , for example, the body surface, when the detection value of the separated distance Lw becomes the target value Lwp. 
     The target value Lwp is not particularly limited and is appropriately set according to conditions. For example, it can be preferable that the target value Lwp is about 5 mm to 60 mm, and, for example, it can be more preferable that the target value Lwp is about 10 mm to 40 mm. 
     When the separated distance Lw becomes the target value Lwp, the control unit  131  carries out predetermined informing by each of the display unit  133  and the buzzer  134 . Specifically, predetermined information can be displayed on the display unit  133  and the buzzer  134  can be sounded, which can allow the operator to understand that the distal portion of the puncture needle assembly  9  is located near the guide portion  102 . For example, in this case, the operator can stop the rotary movement of the puncture needle assembly  9 , which can help prevent the puncture needle assembly  9  from penetrating the body surface on the side of the guide portion  102  and forming the non-through-hole in living body tissues. 
     In accordance with an exemplary embodiment, the configuration may be so made that the separated distances Lu, Lv, and Lw are always displayed on the display unit  133 . This is the same also in the respective embodiments to be described later. 
     Next, regarding the control operation of the control unit  131  of the puncture apparatus  1 , representatively a case of detecting the separated distance Lu between the distal portion of the puncture needle assembly  9  and the urethral-insertion portion  31  and the separated distance Lv between the distal portion of the puncture needle assembly  9  and the vaginal-insertion portion  2  will be described based on the flowchart illustrated in  FIG. 4 . 
     First, the measurement time ts during which measurement is performed, the measurement interval Δt, the maximum value Lvmax and the minimum value Lvmin of the allowable range of the separated distance Lv, and the maximum value Lumax and the minimum value Lumin of the allowable range of the separated distance Lu are set in advance. In accordance with an exemplary embodiment, these measurement time ts, measurement interval Δt, maximum value Lvmax, minimum value Lvmin, maximum value Lumax, and minimum value Lumin can be each arbitrarily set by the operation unit  132 . Then, when a start button, not illustrated, of the operation unit  132  is pressed, the control unit  131  carries out control described below. 
     In accordance with an exemplary embodiment, the measurement time ts is not particularly limited and is appropriately set according to conditions. For example, it can be preferable that the measurement time ts is about 4 seconds to 60 seconds, and, for example, it is more preferable that the measurement time ts is about 10 seconds to 30 seconds. 
     Furthermore, the measurement interval Δt is not particularly limited and is appropriately set according to conditions. For example, it can be preferable that the measurement interval Δt is about 0.1 seconds to 2 seconds, and, for example, it can be more preferable that the measurement interval Δt is about 0.2 seconds to 1 second. 
     As illustrated in  FIG. 4 , time t indicating the elapsed time from the start of this control can be set to 0 and the control unit  131  first resets and starts a timer not illustrated to start measurement of the measurement interval Δt (step S 101 ). 
     Subsequently, the control unit  131  determines whether the time t has reached the measurement interval Δt (step S 102 ). If the time t has reached the measurement interval Δt, the control unit  131  obtains the separated distance Lv (step S 103 ). 
     In the step S 103 , the control unit  131  carries out transmission and reception of ultrasound by the ultrasonic sensor  72  and obtains the time between the timing of the transmission of the ultrasound and the timing of the reception. Based on the time, the control unit  131  can calculate the separated distance Lv. 
     Subsequently, the control unit  131  can determine whether or not the obtained separated distance Lv is equal to or smaller than the maximum value Lvmax of the allowable range (step S 104 ). If the separated distance Lv is larger than the maximum value Lvmax of the allowable range, the control unit  131  executes abnormality detection processing (step S 105 ). 
     In this abnormality detection processing, the control unit  131  displays alarm information on the display unit  133  and sounds the buzzer  134  for example. As the alarm information, for example, “the needle exists at a position remote from the vagina,” “please check whether the vaginal-insertion portion is correctly set,” can be used. 
     In accordance with an exemplary embodiment, the operator can know the existence of some kind of abnormality due to the sounding of the buzzer  134  and can understand the contents of the abnormality, coping methods, and so forth according to the contents of the displaying on the display unit  133 . 
     Furthermore, if the separated distance Lv is equal to or smaller than the maximum value Lvmax of the allowable range in the step S 104 , the control unit  131  can determine whether or not the obtained separated distance Lv is equal to or larger than the minimum value Lvmin of the allowable range (step S 106 ). If the separated distance Lv is smaller than the minimum value Lvmin of the allowable range, the control unit  131  executes the abnormality detection processing (step S 107 ) to end this program. 
     In this abnormality detection processing, the control unit  131  displays alarm information on the display unit  133  and sounds the buzzer  134  for example. As the alarm information, for example, “the needle exists at a position close to the vagina,” “please temporarily stop puncture operation of the needle and check the state of the vagina,” can be used. 
     In accordance with an exemplary embodiment, the operator can know the existence of some kind of abnormality due to the sounding of the buzzer  134  and can understand the contents of the abnormality, coping methods, and so forth according to the contents of the displaying on the display unit  133 . 
     Furthermore, if the obtained separated distance Lv is equal to or larger than the minimum value Lvmin of the allowable range in the step S 106 , the control unit  131  can obtain the separated distance Lu (step S 108 ). 
     In the step S 108 , the control unit  131  carries out transmission and reception of ultrasound by the ultrasonic sensor  71  and obtains the time between the timing of the transmission of the ultrasound and the timing of the reception. Based on the time, the control unit  131  calculates the separated distance Lu. 
     Subsequently, the control unit  131  determines whether or not the obtained separated distance Lu is equal to or smaller than the maximum value Lumax of the allowable range (step S 109 ). If the separated distance Lu is larger than the maximum value Lumax of the allowable range, the control unit  131  executes the abnormality detection processing (step S 110 ). 
     In this abnormality detection processing (step S 110 ), the control unit  131  displays alarm information on the display unit  133  and sounds the buzzer  134  for example. As the alarm information, for example, “the needle exists at a position remote from the urethra,” “please check whether the urethral-insertion portion is correctly set,” can be used. 
     In accordance with an exemplary embodiment, the operator can know the existence of some kind of abnormality due to the sounding of the buzzer  134  and can understand the contents of the abnormality, coping methods, and so forth according to the contents of the displaying on the display unit  133 . 
     Furthermore, if the separated distance Lu is equal to or smaller than the maximum value Lumax of the allowable range in the step S 109 , the control unit  131  determines whether or not the obtained separated distance Lu is equal to or larger than the minimum value Lumin of the allowable range (step S 111 ). If the separated distance Lu is smaller than the minimum value Lumin of the allowable range, the control unit  131  executes the abnormality detection processing (step S 112 ) to end this program. 
     In this abnormality detection processing, the control unit  131  can display alarm information on the display unit  133  and sound the buzzer  134  for example. As the alarm information, for example, “the needle exists at a position close to the urethra,” “please temporarily stop puncture operation of the needle and check the state of the urethra,” can be used. 
     In accordance with an exemplary embodiment, the operator can know the existence of some kind of abnormality due to the sounding of the buzzer  134  and can understand the contents of the abnormality, coping methods, and so forth according to the contents of the displaying on the display unit  133 . 
     Furthermore, if the obtained separated distance Lu is equal to or larger than the minimum value Lumin of the allowable range in the step S 111 , the control unit  131  proceeds to the step S 113 . In accordance with an exemplary embodiment, the separated distance Lu falls within the allowable range in this case. 
     Subsequently, the control unit  131  adds the measurement interval Δt to the time t (step S 113 ). 
     Next, the control unit  131  determines whether or not, the time t is smaller than the measurement time ts (step S 114 ). If the time t is smaller than the measurement time ts, the control unit  131  returns to the step S 101  and carries out the step S 101  and the subsequent steps again. That is, the control unit  131  carries out the respective steps of the step S 103  and the subsequent steps at a time interval of Δt. 
     Furthermore, if the time t is equal to or larger than the measurement time ts in the step S 114 , the control unit  131  ends this program. 
     In accordance with an exemplary embodiment, the display color of the display unit  133  may be changed from that in normal time and displaying on the display unit  133  may blink, for example, when there is a need to call operator&#39;s attention, for example, in each of the steps of the abnormality detection processing. 
     Furthermore, in the respective steps of the abnormality detection processing, the pitches of the sound of the buzzer  134  and the patterns of the sound may be identical to each other or may be different from each other. 
     Next, one example of the use method of the puncture apparatus  1  will be described with reference to  FIGS. 5 to 12 . Here, the description will be made about procedure until the inside structural body  94  having the implant  93  for treatment of urinary incontinence of a woman is implanted in a living body by using the puncture apparatus  1 . In this procedure, the puncture hole formed by the puncture apparatus  1  is a non-through-hole formed from an obturator foramen  400   b  on the right side toward an obturator foramen  400   a  on the left side. 
     As illustrated in  FIG. 5 , the puncture apparatus  1  is set to the use state. Specifically, the puncture apparatus  1  is set to a state in which the surface  105  of the support portion  101  in the support member  10  of the first apparatus  11  is placed on the body surface and the surface  106  of the guide portion  102  is put on the body surface. In addition, the puncture apparatus  1  is set to a state in which the urethral-insertion portion  31  of the second apparatus  12  is inserted into a urethra  100  and the vaginal-insertion portion  2  is inserted into a vagina  200 . In accordance with an exemplary embodiment, in the use state, the support portion  101  is put on the portion of the body surface corresponding to (above) the obturator foramen  400   b  on the right side and the guide portion  102  is put on the portion of the body surface corresponding to (above) the obturator foramen  400   a  on the left side. 
     Furthermore, the balloon  61  is inserted into the bladder in the deflated state and a balloon inflation device such as a syringe not illustrated is connected to the port  34 . Then, a working fluid supplied from the balloon inflation device is sent to the inside of the balloon  61  via the lumen  33  to inflate the balloon  61 . Due to this, the inflated balloon  61  gets caught on the bladder neck and thereby the position of the urethral-insertion portion  31  relative to the bladder and the urethra can be fixed. 
     In accordance with an exemplary embodiment, the position of the urethral-insertion portion  31  relative to the interlock portion  4  is changed to adjust the separated distance between the vaginal-insertion portion  2  and the urethral-insertion portion  31  according to need. Specifically, according to need, the male screw  51  is rotated in the loosening direction and the urethral-insertion member  3  is moved toward the left side or right side in  FIG. 2(   a ) relative to the interlock portion  4 . Then, the male screw  51  is rotated in the fastening direction to make a state in which the movement of the urethral-insertion member  3  relative to the interlock portion  4  is inhibited. 
     Next, as illustrated in  FIG. 6 , the puncture needle assembly  9  in the assembled state is inserted into the through-hole  104  of the support portion  101  from the side of the needle tip  921 . 
     Then, as illustrated in  FIGS. 7 to 9 , the puncture needle assembly  9  is thrust directly and rotary movement operation of the puncture needle assembly  9  can be carried out from the side of the support portion  101  toward the side of the guide portion  102 . At this time, the positional relationship among the puncture needle assembly  9 , the urethral-insertion portion  31 , and the vaginal-insertion portion  2  is restricted by the support portion  101  so that the needle tip  921  may pass through the remoter side from the center O of the circular arc of the outer tube  91  (lower side in  FIG. 7 ) than the urethral-insertion portion  31 , for example, the needle tip  921  may pass between the urethral-insertion portion  31  and the vaginal-insertion portion  2 . Due to this, the puncture hole formed by the puncture needle assembly  9  is a hole passing through a very thin membrane of living body tissues between the urethra  100  and the vagina  200 . 
     In accordance with an exemplary embodiment, as described above, in the puncture apparatus  1 , transmission and reception of ultrasound can be carried out by the ultrasonic sensors  71  and  72  and the aforementioned respective steps of processing are carried out based on control by the control unit  131 . 
     As illustrated in  FIG. 7 , the distal portion of the puncture needle assembly  9  thereby comes close to the urethral-insertion portion  31  and the vaginal-insertion portion  2  and the separated distance Lu between the distal portion of the puncture needle assembly  9  and the urethral-insertion portion  31  and the separated distance Lv between the distal portion of the puncture needle assembly  9  and the vaginal-insertion portion  2  are detected. In each of a case in which the separated distance Lu is too small and a case in which the separated distance Lv is too small, predetermined alarm information can be displayed on the display unit  133  and the buzzer  134  can be sounded. In this case, for example, the operator can temporarily remove the puncture needle assembly  9  and change the position of the support member  10  to change the trajectory of the puncture needle assembly  9 , which can help prevent the puncture needle assembly  9  from puncturing the urethra and puncturing the vaginal wall. 
     Furthermore, as illustrated in  FIG. 9 , when the separated distance Lw between the distal portion of the puncture needle assembly  9  and the guide portion  102  is detected and the separated distance Lw becomes the target value Lwp, predetermined information is displayed on the display unit  133  and the buzzer  134  is sounded. Thus, the operator ends the rotary movement operation of the puncture needle assembly  9 , which can help prevent the puncture needle assembly  9  from penetrating the body surface on the side of the guide portion  102  and forming a non-through-hole as the puncture hole for implanting the implant  93  in living body tissues. 
     Next, as illustrated in  FIG. 10 , only the outer tube  91  is pulled from the puncture needle assembly  9  in the opposite direction of the aforementioned direction and the outer tube  91  is withdrawn. The puncture needle assembly  9  thereby becomes the decomposed state and only the inside structural body  94  is indwelled in living body tissues. Furthermore, by engagement of the step portion  922  of the needle body  92  with living body tissues, this inside structural body  94  is prevented from involuntarily dropping off from living body issues. 
     Next, as illustrated in  FIG. 11 , the support member  10  is removed from the body surface of the patient and the second apparatus  12  is detached from the patient. 
     Next, as illustrated in  FIG. 12 , the length of the implant  93  of the inside structural body  94  is adjusted to such a degree as to be able to support the urethra  100  from the lower side in  FIG. 12 , and the portion of the implant  93  on the opposite side to the needle body  92  is fixed to the body surface. Thereafter, the unnecessary portion of the implant  93  can be cut off and predetermined suture can be performed to end the procedure. 
     As described above, according to this puncture apparatus  1 , in implanting the implant  93  in the living body, it is possible to deal with the implanting only through a less-invasive procedure such as puncture with the puncture needle assembly  9  and a highly-invasive incision or the like does not need to be performed. Therefore, the burden on the patient can be relatively light and the safety of the patient can be relatively high. 
     Furthermore, if the separated distance Lu between the distal portion of the puncture needle assembly  9  and the urethral-insertion portion  31  is too small or if the separated distance Lv between the distal portion of the puncture needle assembly  9  and the vaginal-insertion portion  2  is too small, predetermined alarm information can be displayed on the display unit  133  of the apparatus main body  13  and the buzzer  134  can be sounded. Thus, the situation can be understood by the operator, which can help prevent the puncture needle assembly  9  from puncturing the urethra and puncturing the vaginal wall, providing safety. In addition, the target region of living body tissues can be punctured by the puncture needle assembly  9  and the implant  93  can be implanted in the target region. 
     Moreover, when the separated distance Lw between the distal portion of the puncture needle assembly  9  and the guide portion  102  becomes the target value Lwp, predetermined information can be displayed on the display unit  133  and the buzzer  134  can be sounded. Thus, the puncture needle assembly  9  can be prevented from penetrating the body surface on the side of the guide portion  102  and a non-through-hole can be formed as the puncture hole for implanting the implant  93  in living body tissues. 
     In addition, the operator does not need to perform an incision or the like, which can prevent damage to a fingertip by a surgical knife or the like, providing additional safety for the operator. 
     In accordance with an exemplary embodiment, although the puncture hole formed in the patient by the puncture needle assembly  9  is a hole that does not penetrate the living body surface on one side in the present embodiment, the configuration is not limited thereto and the puncture hole may be a through-hole that penetrates the living body surface on both sides. 
     Furthermore, in the present embodiment, the whole of the puncture needle assembly (puncture needle) is curved into a circular arc shape. However, the configuration is not limited thereto and the puncture needle assembly may be a component only partially having a region curved into a circular arc shape for example. For example, the puncture needle assembly can at least partially have a region curved into a circular arc shape. 
     Moreover, the puncture needle assembly may be any component as long as it is a component at least partially having a curved region. For example, the puncture needle assembly may be a component totally curved into an elliptical arc shape or a component only partially having a region curved into an elliptical arc shape. For example, the puncture needle assembly may be a component at least partially having a region curved into an elliptical arc shape. 
     In addition, the puncture needle assembly may be a component that does not have a curved region, for example, a component forming a straight line shape. 
     Furthermore, the informing means is not limited to the display unit and the buzzer. In accordance with an exemplary embodiment, for example, a unit that informs information by voice and so forth can be used. 
     In accordance with an exemplary embodiment, in the following, description will be so made that the left side is defined as the “distal end” and the right side is defined as the “proximal end” along the longitudinal direction of a puncture needle assembly in  FIG. 13  and the lower side is defined as the “distal end” and the upper side is defined as the “proximal end” along the longitudinal direction of a vaginal-insertion portion and a urethral-insertion portion in  FIG. 14 . 
     Furthermore, in each of  FIGS. 17 to 24 , for high visibility, each ultrasonic sensor and each reflective portion are represented with a large size schematically and slant lines in the living body are omitted. 
     In the following, the second exemplary embodiment will be described mainly about differences from the aforementioned first exemplary embodiment and description of similar matters will be omitted. 
     As illustrated in  FIGS. 13 to 15 , in puncture apparatus  1  of the second exemplary embodiment, a reflective portion  95  that reflects each of ultrasounds transmitted from ultrasonic sensors  73 ,  74 , and  75  to be described later is provided at the distal portion of the puncture needle assembly  9 , for example, the distal portion of the outer tube  91 . This reflective portion  95  is provided on the outer circumferential surface of the outer tube  91  across the whole round. However, the circumferential length thereof may be smaller than the whole round. 
     In accordance with an exemplary embodiment, the configuration of the reflective portion  95  is the same as the reflective portions  21  and  36  and therefore description of the reflective portion  95  is omitted. 
     Furthermore, the ultrasonic sensor  75  is placed on the surface  106  of the guide portion  102  of the support member  10 . This ultrasonic sensor  75  transmits ultrasound toward the lower side in  FIG. 13 . The position of this ultrasonic sensor  75  is not particularly limited. In the present exemplary embodiment, the ultrasonic sensor  75  is disposed at the center portion of the guide portion  102 . 
     In addition, the ultrasonic sensor  73  can be placed on the surface of the middle portion of the urethral-insertion portion  31  on the side of the vaginal-insertion portion  2 . This ultrasonic sensor  73  transmits ultrasound toward the side of the vaginal-insertion portion  2 , for example, the side of the ultrasonic sensor  74  to be described later. 
     Moreover, the ultrasonic sensor  74  is provided on the surface of the middle portion of the vaginal-insertion portion  2  on the side of the urethral-insertion portion  31 . This ultrasonic sensor  74  transmits ultrasound toward the side of the urethral-insertion portion  31 , for example, the side of the ultrasonic sensor  73 . 
     Furthermore, the apparatus main body  13  has transmitting/receiving units  137 ,  138 , and  139  that can perform signal transmission and reception to and from the ultrasonic sensors  73 ,  74 , and  75 , respectively. 
     In accordance with an exemplary embodiment, detection means that detects information relating to the positional relationship between the distal portion of the puncture needle assembly  9  and the urethral-insertion portion  31 , the vaginal-insertion portion  2 , and the guide portion  102  and information relating to the positional relationship between the urethral-insertion portion  31  and the vaginal-insertion portion  2  is configured by the control unit  131 , the transmitting/receiving units  137  to  139 , and the ultrasonic sensors  73  to  75 . 
     In this puncture apparatus  1 , the control unit  131  transmits ultrasound by the ultrasonic sensor  73  and receives the ultrasound by the ultrasonic sensor  74 . Then, the control unit  131  measures the time from the transmission of the ultrasound by the ultrasonic sensor  73  to the reception of the ultrasound by the ultrasonic sensor  74  and obtains separated distance Lx between the urethral-insertion portion  31  and the vaginal-insertion portion  2 . 
     In accordance with an exemplary embodiment, the control unit  131  may transmit ultrasound by the ultrasonic sensor  74  and receive the ultrasound by the ultrasonic sensor  73 . The allowable range of the separated distance Lx, for example, maximum value Lxmax and minimum value Lxmin of the allowable range of the separated distance Lx, can be set in advance. 
     The maximum value Lxmax is not particularly limited and is appropriately set according to conditions. For example, it can be preferable that the maximum value Lxmax is about 15 mm to 50 mm, and, for example, it can be more preferable that the maximum value Lxmax is about 20 mm to 30 mm. 
     Furthermore, the minimum value Lxmin is not particularly limited and is appropriately set according to conditions. For example, it can be preferable that the minimum value Lxmin is about 5 mm to 14 mm, and, for example, it can be more preferable that the minimum value Lxmin is about 6 mm to 10 mm. 
     If this separated distance Lx is in the allowable range, living body tissues can be properly punctured by the puncture needle assembly  9 . In this case, the distal portion of the puncture needle assembly  9 , for example, the needle tip  921 , passes between the urethral-insertion portion  31  and the vaginal-insertion portion  2  relatively easily and can be prevented from puncturing the urethra and the vagina. In accordance with an exemplary embodiment the configuration is so made that, if the separated distance Lx is in the allowable range, this can be informed through that no displaying is made on the display unit  133  and the buzzer  134  makes no sound in the present exemplary embodiment. However, the configuration is not limited thereto. For example, this may be informed by making predetermined displaying on the display unit  133 . 
     On the other hand, if the separated distance Lx is out of the allowable range, for example, if the separated distance Lx is smaller than the minimum value Lxmin of the allowable range, the distance between the urethral-insertion portion  31  and the vaginal-insertion portion  2 , for example, the distance between the urethra and the vagina, is too small, and there is a possibility that the urethra or the vagina is punctured by the puncture needle assembly  9 . Thus, a predetermined alarm can be made by each of the display unit  133  and the buzzer  134 . Specifically, for example, predetermined alarm information can be displayed on the display unit  133  and the buzzer  134  can be sounded, which can allow the operator to understand the situation and prevent the puncture needle assembly  9  from puncturing the urethra or the vagina. 
     Furthermore, if the separated distance Lx is larger than the maximum value Lxmax of the allowable range, the distance between the urethral-insertion portion  31  and the vaginal-insertion portion  2 , for example, the distance between the urethra and the vagina, is large, and there is a possibility that the state is not the normal state. Thus, a predetermined alarm can be made by each of the display unit  133  and the buzzer  134 . Specifically, for example, predetermined alarm information can be displayed on the display unit  133  and the buzzer  134  can be sounded, which can allow the operator to understand the situation and respond to it. 
     Moreover, in this puncture apparatus  1 , ultrasound is transmitted by the ultrasonic sensor  73  and the ultrasound reflected by the reflective portion  95  is received by the ultrasonic sensor  73  to obtain separated distance Lu between the distal portion of the puncture needle assembly  9  and the urethral-insertion portion  31 . Furthermore, ultrasound is transmitted by the ultrasonic sensor  74  and the ultrasound reflected by the reflective portion  95  is received by the ultrasonic sensor  74  to obtain separated distance Lv between the distal portion of the puncture needle assembly  9  and the vaginal-insertion portion  2 . In addition, ultrasound is transmitted by the ultrasonic sensor  75  and the ultrasound reflected by the reflective portion  95  is received by the ultrasonic sensor  75  to obtain separated distance Lw between the distal portion of the puncture needle assembly  9  and the guide portion  102 . 
     Next, the control operation of the control unit  131  of the puncture apparatus  1  in the case of detecting the separated distance Lx between the urethral-insertion portion  31  and the vaginal-insertion portion  2  will be described based on the flowchart illustrated in  FIG. 16 . 
     First, measurement time ts during which measurement is performed, measurement interval Δt, and maximum value Lxmax and minimum value Lxmin of the allowable range of the separated distance Lx can be set in advance. In accordance with an exemplary embodiment, these measurement time ts, measurement interval Δt, maximum value Lxmax, and minimum value Lxmin can each be arbitrarily set by the operation unit  132 . Then, when a start button, not illustrated, of the operation unit  132  is pressed, the control unit  131  carries out control described below. 
     As illustrated in  FIG. 16 , time t indicating the elapsed time from the start of this control is set to 0 and the control unit  131  first resets and starts a timer not illustrated to start measurement of the measurement interval Δt (step S 201 ). 
     Subsequently, the control unit  131  determines whether or not the time t has reached the measurement interval Δt (step S 202 ). If the time t has reached the measurement interval Δt, the control unit  131  obtains the separated distance Lx (step S 203 ). 
     In the step S 203 , the control unit  131  carries out transmission and reception of ultrasound by the ultrasonic sensors  73  and  74  and obtains the time between the timing of the transmission of the ultrasound and the timing of the reception. Based on the time, the control unit  131  calculates the separated distance Lx. 
     Subsequently, the control unit  131  determines whether or not the obtained separated distance Lx is equal to or smaller than the maximum value Lxmax of the allowable range (step S 204 ). If the separated distance Lx is larger than the maximum value Lxmax of the allowable range, the control unit  131  executes abnormality detection processing (step S 205 ). 
     In this abnormality detection processing, the control unit  131  displays alarm information on the display unit  133  and sounds the buzzer  134  for example. As the alarm information, for example, “the distance between the urethra and the vagina is long,” “please check whether each insertion portion is correctly set,” can be used. 
     The operator can know the existence of some kind of abnormality due to the sounding of the buzzer  134  and can understand the contents of the abnormality, coping methods, and so forth according to the contents of the displaying on the display unit  133 . 
     Furthermore, if the separated distance Lx is equal to or smaller than the maximum value Lxmax of the allowable range in the step S 204 , the control unit  131  determines whether or not the obtained separated distance Lx is equal to or larger than the minimum value Lxmin of the allowable range (step S 206 ). If the separated distance Lx is smaller than the minimum value Lxmin of the allowable range, the control unit  131  executes the abnormality detection processing (step S 207 ) to end this program. 
     In this abnormality detection processing, the control unit  131  displays alarm information on the display unit  133  and sounds the buzzer  134  for example. As the alarm information, for example, “the distance between the urethra and the vagina is short,” “please check the state of the urethra and the vagina before carrying out puncture operation of the needle,” can be used. 
     The operator can know the existence of some kind of abnormality due to the sounding of the buzzer  134  and can understand the contents of the abnormality, coping methods, and so forth according to the contents of the displaying on the display unit  133 . 
     Furthermore, if the obtained separated distance Lx is equal to or larger than the minimum value Lxmin of the allowable range in the step S 206 , the control unit  131  adds the measurement interval Δt to the time t (step S 208 ). 
     Next, the control unit  131  determines whether or not, the time t is smaller than the measurement time is (step S 209 ). If the time t is smaller than the measurement time ts, the control unit  131  returns to the step S 201  and carries out the step S 201  and the subsequent steps again. That is, the control unit  131  carries out the respective steps of the step S 203  and the subsequent steps at a time interval of Δt. 
     Furthermore, if the time t is equal to or larger than the measurement time ts in the step S 209 , the control unit  131  ends this program. 
     The control operation of the control unit  131  in the case of detecting the separated distance Lu between the distal portion of the puncture needle assembly  9  and the urethral-insertion portion  31  and the separated distance Lv between the distal portion of the puncture needle assembly  9  and the vaginal-insertion portion  2  is the same as the first embodiment. Therefore, description thereof is omitted. 
     In accordance with an exemplary embodiment, maximum value Lumax and minimum value Lumin of the allowable range of the separated distance Lu may be each automatically set based on the separated distance Lx between the urethral-insertion portion  31  and the vaginal-insertion portion  2 . 
     In this case, for example, it can be preferable that the maximum value Lumax is set in a range of about 40% to 100% of the separated distance Lx, and, for example, it can be more preferable that the maximum value Lumax is set in a range of about 70 to 100%. 
     In addition, for example, it can be preferable that the minimum value Lumin is set in a range of about 5% to 25% of the separated distance Lx, and, for example, it can be more preferable that the minimum value Lumin is set in a range of about 10% to 20%. 
     Furthermore, maximum value Lvmax and minimum value Lvmin of the allowable range of the separated distance Lv may be each automatically set based on the separated distance Lx between the urethral-insertion portion  31  and the vaginal-insertion portion  2 . 
     In this case, for example, it can be preferable that the maximum value Lvmax is set in a range of about 40% to 100% of the separated distance Lx, and, for example, it can be more preferable that the maximum value Lvmax is set in a range of about 70% to 100%. 
     In addition, for example, it can be preferable that the minimum value Lvmin is set in a range of about 5% to 25% of the separated distance Lx, and, for example, it can be more preferable that the minimum value Lvmin is set in a range of 10% to 20%. 
     As illustrated in  FIG. 17 , the puncture apparatus  1  is set to the use state. Specifically, the puncture apparatus  1  is set to a state in which the surface  105  of the support portion  101  in the support member  10  of the first apparatus  11  is placed on the body surface and the surface  106  of the guide portion  102  is put on the body surface. In addition, the puncture apparatus  1  can be set to a state in which the urethral-insertion portion  31  of the second apparatus  12  is inserted into a urethra  100  and the vaginal-insertion portion  2  is inserted into a vagina  200 . Furthermore, a balloon inflation device such as a syringe not illustrated is connected to the port  34  and a working fluid supplied from the balloon inflation device is sent to the inside of the balloon  61  via the lumen  33  to inflate the balloon  61 . In accordance with an exemplary embodiment, the position of the urethral-insertion portion  31  relative to the interlock portion  4  is changed to adjust the separated distance between the vaginal-insertion portion  2  and the urethral-insertion portion  31  according to need. 
     Next, as illustrated in  FIG. 18 , the puncture needle assembly  9  in the assembled state is inserted into the through-hole  104  of the support portion  101  from the side of the needle tip  921 . 
     Then, as illustrated in  FIGS. 19 to 21 , the puncture needle assembly  9  is thrust directly and rotary movement operation of the puncture needle assembly  9  can be carried out from the side of the support portion  101  toward the side of the guide portion  102 . At this time, the positional relationship among the puncture needle assembly  9 , the urethral-insertion portion  31 , and the vaginal-insertion portion  2  is restricted by the support portion  101  so that the needle tip  921  may pass through the remoter side from the center O of the circular arc of the outer tube  91  (lower side in  FIG. 19 ) than the urethral-insertion portion  31 , for example, the needle tip  921  may pass between the urethral-insertion portion  31  and the vaginal-insertion portion  2 . Due to this, the puncture hole formed by the puncture needle assembly  9  is a hole passing through a very thin membrane of living body tissues between the urethra  100  and the vagina  200 . 
     In accordance with an exemplary embodiment, as described above, in the puncture apparatus  1 , transmission and reception of ultrasound are carried out by the ultrasonic sensors  73  and  74  and the aforementioned respective steps of processing are carried out based on control by the control unit  131 . 
     First, the separated distance Lx between the urethral-insertion portion  31  and the vaginal-insertion portion  2  is thereby detected as illustrated in  FIG. 18 . If the separated distance Lx is too small, predetermined alarm information can be displayed on the display unit  133  and the buzzer  134  can be sounded. In this case, for example, the operator removes the second apparatus  12  from the patient and changes the position of the urethral-insertion portion  31  relative to the interlock portion  4  to adjust the separated distance Lx between the urethral-insertion portion  31  and the vaginal-insertion portion  2 , which can help prevent the puncture needle assembly  9  from puncturing the urethra and puncturing the vaginal wall. 
     Furthermore, as illustrated in  FIG. 19 , the distal portion of the puncture needle assembly  9  comes close to the vaginal-insertion portion  2  and the separated distance Lv between the distal portion of the puncture needle assembly  9  and the vaginal-insertion portion  2  is detected. If the separated distance Lv is too small, predetermined alarm information can be displayed on the display unit  133  and the buzzer  134  is sounded. In this case, for example, the operator temporarily removes the puncture needle assembly  9  and changes the position of the support member  10  to change the trajectory of the puncture needle assembly  9 , which can help prevent the puncture needle assembly  9  from puncturing the vaginal wall. 
     Moreover, as illustrated in  FIG. 20 , the distal portion of the puncture needle assembly  9  comes close to the urethral-insertion portion  31  and the separated distance Lu between the distal portion of the puncture needle assembly  9  and the urethral-insertion portion  31  is detected. If the separated distance Lu is too small, predetermined alarm information can be displayed on the display unit  133  and the buzzer  134  can be sounded. In this case, for example, the operator temporarily removes the puncture needle assembly  9  and changes the position of the support member  10  to change the trajectory of the puncture needle assembly  9 , which can help prevent the puncture needle assembly  9  from puncturing the urethra. 
     Furthermore, as illustrated in  FIG. 21 , when the separated distance Lw between the distal portion of the puncture needle assembly  9  and the guide portion  102  is detected and the separated distance Lw becomes a target value Lwp, predetermined information is displayed on the display unit  133  and the buzzer  134  is sounded. Thus, the operator ends the rotary movement operation of the puncture needle assembly  9 , which can help prevent the puncture needle assembly  9  from penetrating the body surface on the side of the guide portion  102  and forming a non-through-hole as the puncture hole for implanting the implant  93  in living body tissues. 
     Next, as illustrated in  FIG. 22 , only the outer tube  91  is pulled from the puncture needle assembly  9  in the opposite direction of the aforementioned direction and the outer tube  91  is withdrawn. The puncture needle assembly  9  thereby becomes the decomposed state and only the inside structural body  94  is indwelled in living body tissues. Furthermore, by engagement of the step portion  922  of the needle body  92  with living body tissues, this inside structural body  94  is prevented from involuntarily dropping off from living body tissues. 
     Next, as illustrated in  FIG. 23 , the support member  10  is removed from the body surface of the patient and the second apparatus  12  is detached from the patient. 
     Next, as illustrated in  FIG. 24 , the length of the implant  93  of the inside structural body  94  is adjusted to such a degree as to be able to support the urethra  100  from the lower side in  FIG. 24 , and the portion of the implant  93  on the opposite side to the needle body  92  is fixed to the body surface. Thereafter, the unnecessary portion of the implant  93  is cut off and predetermined suture and so forth are performed to end the procedure. 
     According to this puncture apparatus  1 , the same effects as those of the aforementioned first embodiment can be achieved. 
     In accordance with an exemplary embodiment, in the following, description will be so made that the lower side is defined as the “distal end” and the upper side is defined as the “proximal end” along the longitudinal direction of a vaginal-insertion portion and a urethral-insertion portion in  FIGS. 25A-25C . 
     In the following, the third exemplary embodiment will be described mainly about differences from the aforementioned second embodiment and description of similar matters will be omitted. 
     As illustrated in  FIGS. 25A-25C  and  26 , in puncture apparatus  1  of the third exemplary embodiment, an ultrasonic sensor  76  is further disposed on the surface of the middle portion of the urethral-insertion portion  31  on the side of the vaginal-insertion portion  2 . This ultrasonic sensor  76  transmits ultrasound toward the side of the vaginal-insertion portion  2 . This ultrasonic sensor  76  is disposed on the side of the balloon  61  relative to the ultrasonic sensor  74 , for example, disposed near the balloon  61 . 
     Furthermore, the apparatus main body  13  further has a transmitting/receiving unit  140  that performs signal transmission and reception to and from the ultrasonic sensor  76 . 
     In accordance with an exemplary embodiment, detection means that detects information relating to the positional relationship between the distal portion of the puncture needle assembly  9  and two different regions of the urethral-insertion portion  31  in the longitudinal direction, the vaginal-insertion portion  2 , and the guide portion  102  and information relating to the positional relationship between the urethral-insertion portion  31  and the vaginal-insertion portion  2  is configured by the control unit  131 , the transmitting/receiving units  137  to  140 , and the ultrasonic sensors  73  to  76 . 
     In this puncture apparatus  1 , the control unit  131  transmits ultrasound by the ultrasonic sensor  76 . This ultrasound reflects at the reflective portion  95  provided on the puncture needle assembly  9  and is received by the ultrasonic sensor  76 . Then, the control unit  131  measures the time from the transmission of the ultrasound by the ultrasonic sensor  76  to the reception and obtains separated distance Lub between the distal portion of the puncture needle assembly  9  and the urethral-insertion portion  31 . 
     The control unit  131  can compare the separated distance Lub detected by using this ultrasonic sensor  76  with separated distance Lu between the distal portion of the puncture needle assembly  9  and the urethral-insertion portion  31 , detected by using the ultrasonic sensor  73 , and determines whether or not the distal portion of the puncture needle assembly  9  is too close to the bladder. 
     If the separated distance Lub is smaller than the separated distance Lu, the distal portion of the puncture needle assembly  9  is too close to the bladder and there is a possibility that the bladder is punctured by the puncture needle assembly  9 . Thus, a predetermined alarm can be made by each of the display unit  133  and the buzzer  134 . Specifically, for example, predetermined alarm information can be displayed on the display unit  133  and the buzzer  134  can be sounded, which can allow the operator to understand the situation and help prevent the puncture needle assembly  9  from puncturing the bladder. 
     Next, the control operation of the control unit  131  of the puncture apparatus  1  in the case of detecting the separated distances Lu and Lub between the distal portion of the puncture needle assembly  9  and the urethral-insertion portion  31  will be described based on the flowchart illustrated in  FIG. 27 . 
     First, measurement time is during which measurement is performed, measurement interval Δt, and maximum value Lumax and minimum value Lumin of the allowable range of the separated distance Lu are set in advance. In accordance with an exemplary embodiment, the measurement time ts, measurement interval Δt, maximum value Lumax, and minimum value Lumin can each be arbitrarily set by the operation unit  132 . Then, when a start button, not illustrated, of the operation unit  132  is pressed, the control unit  131  carries out control described below. 
     As illustrated in  FIG. 27 , time t indicating the elapsed time from the start of this control is set to 0 and the control unit  131  first resets and starts a timer not illustrated to start measurement of the measurement interval Δt (step S 301 ). 
     Subsequently, the control unit  131  determines whether the time t has reached the measurement interval Δt (step S 302 ). If the time t has reached the measurement interval Δt, the control unit  131  obtains the separated distance Lu (step S 303 ) and obtains the separated distance Lub (step S 304 ). 
     In the step S 303 , the control unit  131  carries out transmission and reception of ultrasound by the ultrasonic sensor  73  and obtains the time between the timing of the transmission of the ultrasound and the timing of the reception. Based on the time, the control unit  131  calculates the separated distance Lu. Furthermore, in the step S 304 , the control unit  131  carries out transmission and reception of ultrasound by the ultrasonic sensor  76  and obtains the time between the timing of the transmission of the ultrasound and the timing of the reception. Based on the time, the control unit  131  calculates the separated distance Lub. 
     Subsequently, the control unit  131  determines whether or not the obtained separated distance Lu is equal to or smaller than the maximum value Lumax of the allowable range (step S 305 ). If the separated distance Lu is larger than the maximum value Lumax of the allowable range, the control unit  131  executes abnormality detection processing (step S 306 ). 
     In this abnormality detection processing (step S 306 ), the control unit  131  displays alarm information on the display unit  133  and sounds the buzzer  134  for example. As the alarm information, for example, “the needle exists at a position remote from the urethra,” “please check whether the urethral-insertion portion is correctly set,” can be used. 
     The operator can know the existence of some kind of abnormality due to the sounding of the buzzer  134  and can understand the contents of the abnormality, coping methods, and so forth according to the contents of the displaying on the display unit  133 . 
     Furthermore, if the separated distance Lu is equal to or smaller than the maximum value Lumax of the allowable range in the step S 305 , the control unit  131  determines whether or not the obtained separated distance Lu is equal to or larger than the minimum value Lumin of the allowable range (step S 307 ). If the separated distance Lu is smaller than the minimum value Lumin of the allowable range, the control unit  131  executes the abnormality detection processing (step S 308 ) to end this program. 
     In this abnormality detection processing, the control unit  131  displays alarm information on the display unit  133  and sounds the buzzer  134  for example. As the alarm information, for example, “the needle exists at a position close to the urethra,” “please temporarily stop puncture operation of the needle and check the state of the urethra,” can be used. 
     The operator can know the existence of some kind of abnormality due to the sounding of the buzzer  134  and can understand the contents of the abnormality, coping methods, and so forth according to the contents of the displaying on the display unit  133 . 
     Furthermore, if the obtained separated distance Lu is equal to or larger than the minimum value Lumin of the allowable range in the step S 307 , the control unit  131  determines whether or not the separated distance Lub is equal to or larger than the separated distance Lu (step S 309 ). If the separated distance Lub is smaller than the separated distance Lu, the control unit  131  executes the abnormality detection processing (step S 310 ). 
     In this abnormality detection processing, the control unit  131  displays alarm information on the display unit  133  and sounds the buzzer  134  for example. As the alarm information, for example, “the needle exists at a position close to the bladder,” “please temporarily stop puncture operation of the needle and check the state of the bladder,” can be used. 
     The operator can know the existence of some kind of abnormality due to the sounding of the buzzer  134  and can understand the contents of the abnormality, coping methods, and so forth according to the contents of the displaying on the display unit  133 . 
     Furthermore, if the separated distance Lub is equal to or larger than the separated distance Lu in the step S 309 , the control unit  131  adds the measurement interval Δt to the time t (step S 311 ). 
     Next, the control unit  131  determines whether the time t is smaller than the measurement time ts (step S 312 ). If the time t is smaller than the measurement time ts, the control unit  131  returns to the step S 301  and carries out the step S 301  and the subsequent steps again. That is, the control unit  131  carries out the respective steps of the step S 303  and the subsequent steps at a time interval of Δt. 
     Furthermore, in accordance with an exemplary embodiment, if the time t is equal to or larger than the measurement time ts in the step S 312 , the control unit  131  ends this program. 
     According to this puncture apparatus  1 , the same effects as those of the aforementioned second exemplary embodiment are achieved. 
       FIG. 28  is a partial sectional view illustrating a fourth exemplary embodiment of the puncture apparatus of the present disclosure. In accordance with an exemplary embodiment, a puncture needle assembly is schematically illustrated in  FIG. 28 . 
     In accordance with an exemplary embodiment, in the following, description will be so made that the left side is defined as the “distal end” and the right side is defined as the “proximal end” along the longitudinal direction of the puncture needle assembly in  FIG. 28 . 
     In the following, the fourth embodiment will be described mainly about differences from the aforementioned first embodiment and description of similar matters will be omitted. 
     As illustrated in  FIGS. 28A-28C , the puncture apparatus  1  of the fourth exemplary embodiment has, instead of the ultrasonic sensor and the reflective portion, a balloon  81  provided for the urethral-insertion portion  31  and a pressure sensor  82  that is provided in the balloon  81  of the urethral-insertion portion  31  and detects the pressure in the balloon  81  as the detection means that detects information relating to the positional relationship between the distal portion of the puncture needle assembly  9  and the urethral-insertion portion  31 . In accordance with an exemplary embodiment, the configuration of the balloon  81  and so forth is similar to that of the aforementioned balloon  61  and so forth and therefore description thereof is omitted. Furthermore, the aforementioned balloon  61  may be substituted as the balloon  81 . 
     A detection result of the pressure sensor  82 , for example, a signal indicating the pressure in the balloon  81  detected by the pressure sensor  82 , is input to the control unit  131  and the control unit  131  carries out respective kinds of control based on the detection result of the pressure sensor  82 . 
     For example, as illustrated in  FIG. 28A , when the distal portion of the puncture needle assembly  9  is located at a proper position with respect to the urethral-insertion portion  31 , the distal portion of the puncture needle assembly  9  is separate from the balloon  81  and is not deforming the balloon  81 . Thus, the detection result of the pressure sensor  82  is a result corresponding to this. In this case, the distal portion of the puncture needle assembly  9 , for example, the needle tip  921 , passes between the urethral-insertion portion  31  and the vaginal-insertion portion  2  and can be prevented from puncturing the urethra and the vagina. 
     Furthermore, in each of a case in which the distal portion of the puncture needle assembly  9  is slightly too close to the urethral-insertion portion  31  as illustrated in  FIGS. 28A and 28B  (position deviation B) and a case in which the distal portion of the puncture needle assembly  9  is too close to the urethral-insertion portion  31  as illustrated in  FIGS. 28A and 28C  (position deviation A), there is a possibility that the urethra is punctured by the puncture needle assembly  9 . In the case of the position deviation B, a high pressure compared with the case in which the distal portion of the puncture needle assembly  9  is separate from the balloon  81  and is not deforming the balloon  81  is detected by the pressure sensor  82 . In addition, in the case of the position deviation A, a high pressure compared with the case of the position deviation B is detected by the pressure sensor  82 . Based on the detection result of the pressure sensor  82 , the control unit  131  makes a predetermined alarm by each of the display unit  133  and the buzzer  134  as described above. Specifically, as described above, predetermined alarm information is displayed on the display unit  133  and the buzzer  134  is sounded, which can allow the operator to understand the situation and prevent the puncture needle assembly  9  from puncturing the urethra. In accordance with an exemplary embodiment, the configuration may be so made that pieces of alarm information different from each other between the position deviation B and the position deviation A are displayed on the display unit  133 . 
     According to this puncture apparatus  1 , the same effects as those of the aforementioned first exemplary embodiment are achieved. 
     Although the puncture apparatus of the present disclosure is described above about the embodiments illustrated in the diagrams, the present disclosure is not limited thereto and each portion configuring the puncture apparatus can be replaced by an arbitrary configuration capable of exerting a similar function. Furthermore, an arbitrary constituent object may be added. 
     Moreover, the puncture apparatus of the present disclosure may be apparatus obtained by combining arbitrary two or more configurations (characteristics) of the respective embodiments. 
     In accordance with an exemplary embodiment, although the respective distances themselves are obtained as the pieces of information relating to the respective positional relationships in the embodiments, the present disclosure is not limited thereto and the configuration may be so made that for example, values proportional to the respective distances or the like are obtained as the pieces of information relating to the respective positional relationships. 
     Furthermore, in the present disclosure, the configuration may be so made that ultrasonic image data is created based on a signal transmitted from the ultrasonic sensor (ultrasonic oscillator) and an ultrasonic image is displayed. 
     Moreover, in the embodiments, the configuration is so made that the pieces of information relating to the respective positional relationships are detected by carrying out transmission and reception of ultrasound by the ultrasonic sensor or detecting the pressure by the pressure sensor. However, the present disclosure is not limited thereto and the configuration may be so made that the pieces of information relating to the respective positional relationships are detected optically or magnetically for example. 
     In the case of optically detecting the pieces of information relating to the respective positional relationships, for example a light emitting element is provided on the puncture needle assembly (puncture needle) and a light receiving element is provided on each of the urethral-insertion portion, the vaginal-insertion portion, and the guide portion of the support member. In accordance with an exemplary embodiment it is preferable to use, as the light emitting element, an element that emits light whose transmittance to living body tissues is comparatively high, specifically for example, near-infrared light. 
     In the case of magnetically detecting the pieces of information relating to the respective positional relationships, for example a permanent magnet is provided on the puncture needle assembly (puncture needle) and a magnetic sensor is provided on each of the urethral-insertion portion, the vaginal-insertion portion, and the guide portion of the support member. 
     Puncture apparatus of the present disclosure is characterized by including an insertion portion that is insertable into a living body, a puncture needle that punctures living body tissues near the insertion portion in a state in which the insertion portion is inserted into the living body, and detection means that detects information relating to a positional relationship between a distal portion of the puncture needle and the insertion portion. 
     According to the present disclosure, the region that must not be punctured can be prevented from being punctured when living body tissues are punctured by the puncture needle. In addition, the burden on the patient is light and the safety of the patient is high. Furthermore, the safety of the operator is also high. 
     For example, when the puncture apparatus of the present disclosure is used for treatment of urinary incontinence of a woman, the insertion portion of the puncture apparatus is inserted into a urethra and the puncture needle is rotationally moved to puncture the living body by the puncture needle. At this time, information relating to the positional relationship between the distal portion of the puncture needle and the insertion portion can be detected and thus puncture of the urethra by the puncture needle can be prevented. 
     Furthermore, in implanting an implant for treatment of urinary incontinence, incision of the vaginal wall is unnecessary and the implant can be implanted by a less-invasive procedure. Moreover, the operator can also prevent damage to a fingertip. 
     Therefore, the puncture apparatus of the present disclosure has industrial applicability. 
     Having described, by way of example, embodiments of the puncture apparatus and method, it is to be understood that the invention here is not limited to those precise embodiments and that various changes and modifications could be effected therein by one skilled in the art without departing from the spirit or scope of the invention as defined in the claims.