JP2015061554A - Medical tube - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical tube which enables an implant to be easily and reliably discharged from a body and enables indwelling of the implant in a living body.SOLUTION: A sheath 30 comprises a tubular body 31 into which an implant to be indwelled in a living body is inserted. The body 31 comprises a first division tube and a second division tube which can be divided in the middle of the body 31 in the axial direction. The first division tube comprises, at least on one end of the first division tube, a first soft portion softer than the end. The second division tube comprises, at least on one end of the second division tube, a second soft portion softer than the end.

Description

  The present invention relates to a medical tube.

  In the case of urinary incontinence, particularly stress urinary incontinence, urine leakage occurs due to abdominal pressure applied during normal exercise, laughing, coughing, sneezing and the like. The cause of this is, for example, that the pelvic floor muscle, which is a muscle that supports the urethra, is loosened due to childbirth and the like.

  Surgical therapy is effective for treating urinary incontinence. For example, a band-like implant called a “sling” is used, and the sling is placed in the body, and the urethra is supported by the sling (see, for example, Patent Document 1). . In order to place the sling in the body, the operator incises the vagina with a scalpel, peels off the space between the urethra and the vagina, and uses the puncture needle or the like to connect the peeled portion and the outside through a closed hole. In such a state, the sling is left in the body.

  However, if the vaginal wall is incised, there is a risk that a sling may be exposed in the vagina from the wound created by the incision, and there may be complications such as infection from the wound. Moreover, since the vagina wall is incised, the invasion is large and the burden on the patient is large. In addition, there is a possibility that the urethra and the like may be damaged with a scalpel during the procedure by the operator, and the operator himself may damage the fingertip with the scalpel.

JP 2010-99499 A

  As a method for solving the above-mentioned problem, a sling can be obtained without using an incision in the vaginal wall by using a medical tube assembly including a medical tube and a curved long insertion portion inserted into the medical tube. A method of indwelling in vivo In this method, first, a living body is punctured from the body surface with a needle body provided at the distal end portion of the medical tube assembly, the needle body is passed between the urethra and the vagina, and again from the body surface. Projecting outward (hereinafter, this operation is referred to as “puncture operation”). Thereby, the site | part in the middle of a medical tube assembly is located between a urethra and the vagina, and the both ends of a medical tube assembly protrude outside from the body surface, respectively. Next, remove the insertion part from the medical tube, insert the sling into the medical tube from one end of the medical tube, remove only the medical tube from the living body, and place the sling in the living body. To do.

  However, in the medical tube, when only the medical tube is removed from the living body from the state where the sling is inserted into the medical tube, at the outlet of the sling of the medical tube, that is, at the end of the medical tube, There is a problem that the sling is rubbed with “crisp” at the end, and the sling is difficult to be discharged from the end of the medical tube.

  The objective of this invention is providing the medical tube which can discharge | emit an implant from the inside of a main body easily and reliably, and can leave indwelling.

Such an object is achieved by the present inventions (1) to (9) below.
(1) A medical tube into which an implant placed in a living body is inserted and has a tubular main body,
The said main body has a flexible part more flexible than this edge part in the at least one edge part, The medical tube characterized by the above-mentioned.

  (2) The medical tube according to (1), wherein the flexible part is deformed when contacting the implant.

  (3) The medical tube according to (2), wherein the flexible portion is deformed in a direction to release the force when receiving a force from the implant.

  (4) The medical device according to any one of (1) to (3), wherein the flexible portion has a portion where a degree of flexibility gradually increases from a central portion side of the main body toward the one end portion side. For tubes.

(5) A medical tube in which an implant to be placed in a living body is inserted and has a tubular body,
The main body has a first divided tube and a second divided tube that can be divided in the axial direction of the main body,
The first divided tube has a first flexible portion that is more flexible than the end portion at at least one end portion of the first divided tube;
The second divided tube has a second flexible portion that is softer than the end portion at at least one end portion of the second divided tube.

  (6) The medical tube according to (5), wherein the first flexible portion and the second flexible portion are each deformed when contacting the implant.

  (7) The medical tube according to (6), wherein each of the first flexible portion and the second flexible portion is deformed in a direction to release the force when receiving a force from the implant.

(8) The first flexible portion has a portion where the degree of flexibility gradually decreases toward the central portion of the first divided tube,
The said 2nd flexible part is a medical tube of any one of said (5) thru | or (7) which has a site | part where the degree of flexibility gradually reduces toward the center part side of the said 2nd division | segmentation tube.

(9) The main body has a curved portion,
The main body is rigid so that the curvature and lumen of the main body can be maintained in a state of being inserted into a living body, and the first divided tube and the second divided tube are connected. The medical tube according to any one of (5) to (8), wherein the lumen of the main body communicates over the entire length.

  According to the present invention, since the main body has the most flexible flexible portion at at least one end portion, the implant can be easily and reliably inserted into the main body from the one end portion. The implant can be easily and reliably discharged from the one end to the outside, whereby the implant can be easily and reliably placed in the living body.

  The first divided tube has the most flexible first flexible portion at one end, for example, the end of the first divided tube on the second divided tube side, and the second divided tube has By having the most flexible second flexible part at one end, for example, the end of the second divided tube on the first divided tube side, the implant can be easily and reliably discharged from within the main body. Thus, the implant can be placed in the living body easily and reliably.

FIG. 1 is a perspective view showing a puncture device to which a medical tube assembly according to a first embodiment of the present invention is applied. FIG. 2 is a side view of the puncture device shown in FIG. FIG. 3 is a plan view showing an operation member of the puncture apparatus shown in FIG. 4A and 4B are diagrams showing a puncture member included in the puncture apparatus shown in FIG. 1, wherein FIG. 4A is a perspective view and FIG. 4B is a cross-sectional view taken along line AA in FIG. FIG. 5 is a cross-sectional view of the puncture member shown in FIG. 6A and 6B are diagrams showing a state maintaining mechanism included in the puncture member shown in FIG. 4A, wherein FIG. 6A is a top view, and FIGS. 6B and 6C are cross-sectional views. FIG. 7 is a partially enlarged view showing a state maintaining mechanism of the puncture member shown in FIG. 3, wherein (a) and (b) are plan views showing modifications, and (c) is a plan view showing this embodiment. It is. 8A and 8B are diagrams showing a second anchor included in the puncture device shown in FIG. 1, wherein FIG. 8A is a cross-sectional view and FIG. 8B is a cross-sectional view showing a state where the puncture member is engaged. FIG. 9 is a view showing a first anchor of the puncture device shown in FIG. 1, wherein (a) is a cross-sectional view and (b) is a cross-sectional view showing a state where the puncture member is engaged. FIG. 10 is a cross-sectional view showing a guide portion of a frame provided in the puncture apparatus shown in FIG. FIG. 11 is a cross-sectional view showing a guide portion of a frame provided in the puncture apparatus shown in FIG. FIG. 12 is a cross-sectional view showing a guide portion of a frame provided in the puncture apparatus shown in FIG. FIG. 13 is a plan view showing a frame fixing portion provided in the puncture apparatus shown in FIG. 1. FIG. 14 is a side view of an insertion tool included in the puncture device shown in FIG. 1. FIG. 15 is a diagram showing the positional relationship between the puncture member and the closing hole (pelvis), in which (a) is a side view and (b) is a front view. 16 is a partially enlarged view of a vaginal insertion member included in the insertion tool shown in FIG. 17A is a cross-sectional view showing an example of the shape of the vagina wall, and FIG. 17B is a cross-sectional view showing a state where the vaginal insertion portion is inserted into the vagina shown in FIG. FIG. 18 is a view showing an implant used together with the puncture device shown in FIG. 19 (a) and 19 (b) are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. 20 (a) and 20 (b) are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. FIG. 21 is a side view showing the relationship between the puncture device and the pelvis in the state shown in FIG. 22 (a) and 22 (b) are diagrams for explaining an operation procedure of the puncture apparatus shown in FIG. FIG. 23 is a side view showing the relationship between the puncture device and the pelvis in the state shown in FIG. FIG. 24 is a cross-sectional view showing the posture of the puncture member relative to the urethra in the state shown in FIG. 25 (a) and 25 (b) are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. FIGS. 26A and 26B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. FIG. 27 is a perspective view showing a medical tube assembly according to a second embodiment of the present invention. FIG. 28 is a cross-sectional view showing a modification of the medical tube assembly shown in FIG. FIG. 29 is a plan view showing a medical tube assembly according to a third embodiment of the present invention. FIG. 30 is a plan view showing a medical tube assembly according to a fourth embodiment of the present invention. FIG. 31 is a plan view showing a medical tube assembly according to a fifth embodiment of the present invention. FIG. 32 is a plan view showing a medical tube assembly according to a sixth embodiment of the present invention. FIG. 33 is a plan view showing a medical tube assembly according to a seventh embodiment of the present invention. FIG. 34 is a plan view showing a medical tube assembly according to an eighth embodiment of the present invention. FIG. 35 is a plan view showing a medical tube assembly according to a ninth embodiment of the present invention. FIG. 36 is a plan view showing a medical tube assembly according to a tenth embodiment of the present invention. FIG. 37 is a side view showing a medical tube assembly according to an eleventh embodiment of the present invention. FIG. 38 is a side view showing a distal end portion of the medical tube assembly shown in FIG. 39 is a cross-sectional view taken along line BB in FIG. FIG. 40 is a view for explaining an example of use of the medical tube assembly shown in FIG. FIG. 41 is a view for explaining an example of use of the medical tube assembly shown in FIG. FIG. 42 is a view for explaining an example of use of the medical tube assembly shown in FIG. FIG. 43 is a view for explaining an example of use of the medical tube assembly shown in FIG. FIG. 44 is a view for explaining an example of use of the medical tube assembly shown in FIG. FIG. 45 is a side view showing the distal end portion of the medical tube assembly according to the twelfth embodiment of the present invention. 46 is a cross-sectional view taken along the line CC in FIG. FIG. 47 is a cross-sectional view showing a portion in the middle of the medical tube assembly according to the thirteenth embodiment of the present invention. FIG. 47 is a cross-sectional view showing a portion in the middle of the medical tube assembly according to the fourteenth embodiment of the present invention. FIG. 49 is a sectional view showing a medical tube (medical tube assembly) according to a fifteenth embodiment of the present invention. FIG. 50 is a view for explaining an example of use of the medical tube (medical tube assembly) shown in FIG. 49. FIG. 51 is a diagram for explaining an example of use of the medical tube (medical tube assembly) shown in FIG. FIG. 52 is a view for explaining an example of use of the medical tube (medical tube assembly) shown in FIG. FIG. 53 is a cross-sectional view showing a medical tube (medical tube assembly) according to a sixteenth embodiment of the present invention. FIG. 54 is a view for explaining an example of use of the medical tube (medical tube assembly) shown in FIG. FIG. 55 is a cross-sectional view showing a medical tube (medical tube assembly) according to a seventeenth embodiment of the present invention. FIG. 56 is a view for explaining an example of use of the medical tube (medical tube assembly) shown in FIG. FIG. 57 is a view for explaining an example of use of the medical tube (medical tube assembly) shown in FIG. FIG. 58 is a view for explaining an example of use of the medical tube (medical tube assembly) shown in FIG. FIG. 59 is a perspective view showing a medical tube according to the eighteenth embodiment of the present invention. FIG. 60 is a view for explaining an example of use of the medical tube shown in FIG. 61 is a cross-sectional view taken along line HH in FIG. FIG. 62 is a perspective view showing a medical tube according to a nineteenth embodiment of the present invention. FIG. 63 is a view for explaining an example of use of the medical tube shown in FIG. FIG. 64 is a sectional view showing a medical tube according to the twentieth embodiment of the present invention. FIG. 65 is a perspective view showing a medical tube according to the twenty-first embodiment of the present invention.

  Hereinafter, the medical tube of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.

<First Embodiment>
FIG. 1 is a perspective view showing a puncture device to which a medical tube assembly according to a first embodiment of the present invention is applied. FIG. 2 is a side view of the puncture device shown in FIG. FIG. 3 is a plan view showing an operation member of the puncture apparatus shown in FIG. 4A and 4B are diagrams showing a puncture member included in the puncture apparatus shown in FIG. 1, wherein FIG. 4A is a perspective view and FIG. 4B is a cross-sectional view taken along line AA in FIG. FIG. 5 is a cross-sectional view of the puncture member shown in FIG. 6A and 6B are diagrams showing a state maintaining mechanism included in the puncture member shown in FIG. 4A, wherein FIG. 6A is a top view, and FIGS. 6B and 6C are cross-sectional views. FIG. 7 is a partially enlarged view showing a state maintaining mechanism of the puncture member shown in FIG. 3, wherein (a) and (b) are plan views showing modifications, and (c) is a plan view showing this embodiment. It is. 8A and 8B are diagrams showing a second anchor included in the puncture device shown in FIG. 1, wherein FIG. 8A is a cross-sectional view and FIG. 8B is a cross-sectional view showing a state where the puncture member is engaged. FIG. 9 is a view showing a first anchor of the puncture device shown in FIG. 1, wherein (a) is a cross-sectional view and (b) is a cross-sectional view showing a state where the puncture member is engaged. FIG. 10 is a cross-sectional view showing a guide portion of a frame provided in the puncture apparatus shown in FIG. FIG. 11 is a cross-sectional view showing a guide portion of a frame provided in the puncture apparatus shown in FIG. FIG. 12 is a cross-sectional view showing a guide portion of a frame provided in the puncture apparatus shown in FIG. FIG. 13 is a plan view showing a frame fixing portion provided in the puncture apparatus shown in FIG. 1. FIG. 14 is a side view of an insertion tool included in the puncture device shown in FIG. 1. FIG. 15 is a diagram showing a positional relationship between the puncture member and the closing hole (pelvis), in which (a) is a side view and (b) is a front view. 16 is a partially enlarged view of a vaginal insertion member included in the insertion tool shown in FIG. 17A is a cross-sectional view showing an example of the shape of the vagina wall, and FIG. 17B is a cross-sectional view showing a state where the vaginal insertion portion is inserted into the vagina shown in FIG. FIG. 18 is a view showing an implant used together with the puncture device shown in FIG. 19 (a) and 19 (b) are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. 20 (a) and 20 (b) are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. FIG. 21 is a side view showing the relationship between the puncture device and the pelvis in the state shown in FIG. 22 (a) and 22 (b) are diagrams for explaining an operation procedure of the puncture apparatus shown in FIG. FIG. 23 is a side view showing the relationship between the puncture device and the pelvis in the state shown in FIG. FIG. 24 is a cross-sectional view showing the posture of the puncture member relative to the urethra in the state shown in FIG. 25 (a) and 25 (b) are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. FIGS. 26A and 26B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG.

  In the following, for convenience of explanation, the left side in FIG. 2 is referred to as “tip”, the right side is referred to as “base end”, the upper side is referred to as “upper”, and the lower side is referred to as “lower”. FIG. 2 shows a state that is not yet used. Hereinafter, for convenience of explanation, this state is also referred to as an “initial state”. The state where the puncture device (insertion tool) shown in FIG. 2 is attached to the patient is also referred to as “attached state”. In FIGS. 5 and 6, the puncture member extending in an arc shape is illustrated as being linearly extended for convenience of explanation.

1. Puncture device First, a puncture device to which the medical tube assembly (medical tube) of the present invention is applied will be described.

  A puncture device 1 shown in FIGS. 1 and 2 is a device used when a living tissue supporting indwelling material for treatment of female urinary incontinence, that is, treatment of urinary incontinence is embedded in a living body.

  The puncture device 1 includes a frame (support portion) 2, a puncture member 3, a urethral insertion member 4, a vaginal insertion member 5, an operation member 7, and anchors 81 and 82. The member 4, the vaginal insertion member 5, the operation member 7, and the anchors 81 and 82 are supported. In the puncture device 1, the urethral insertion member 4 and the vagina insertion member 5 constitute an insertion tool 6. Hereinafter, these will be described in order.

(Operation member)
The operation member 7 is a member for operating the puncture member 3. As shown in FIGS. 1 to 3, the operation member 7 has an insertion portion 71, a shaft portion 73, and a connecting portion 72 that connects the insertion portion 71 and the shaft portion 73. The insertion portion 71, the coupling portion 72, and the shaft portion 73 may be integrally formed, or at least one portion may be formed as a separate body from other portions.

  The insertion portion 71 is a part that is inserted into the puncture member 3 and functions as a stylet that reinforces the puncture member 3 from the inside. By inserting the insertion portion 71 into the puncture member 3, the puncture member 3 is connected to the operation member 7, whereby the operation member 7 can be operated by the operation member 7. Such an insertion portion 71 has an arc shape corresponding to the shape of the puncture member 3. The central angle of the insertion portion 71 is set according to the central angle of the puncture member 3. Further, the distal end portion 711 of the insertion portion 71 is tapered. By having the tapered tip end portion 711, the puncture member 3 can be smoothly inserted into the insertion portion 71.

  In addition, although the cross-sectional shape of the insertion part 71 is circular, it may be flat. The flat shape is not particularly limited. For example, an elliptical shape, a rhombus with rounded corners, a rectangle with rounded corners (flat shape), and a central portion that is wider than both ends. An expanded (expanded) spindle shape may be used.

  The shaft portion 73 intersects the center O of the insertion portion 71 and extends along an axis J1 orthogonal to the plane f1 including the insertion portion 71.

  The connecting portion 72 connects the proximal end portion of the insertion portion 71 and the distal end portion of the shaft portion 73. Moreover, the connection part 72 has comprised the substantially L shape bent in the substantially right angle in the middle. The connecting portion 72 also functions as a grasping portion that the operator grasps when operating the operation member 7.

  Such an operation member 7 is configured to have higher rigidity than the puncture member 3 (main body 31). The constituent material of the operation member 7 is not particularly limited, and for example, various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy can be used.

(Puncture member)
The puncture member 3 is a member for puncturing a living body. The puncture member 3 has a long sheath (medical tube) 30 and a needle body 35 provided at the distal end of the sheath 30 as shown in FIG. The sheath 30 includes a tubular main body 31 and a state maintaining mechanism 34.

  The main body 31 is composed of a long tubular body (tube), and the distal end and the proximal end are open. Such a main body 31 has an internal space into which the implant main body 91 can be inserted. The internal space is configured by the lumen of the main body 31. The main body 31 has a curved shape curved in an arc shape, and has a flat cross-sectional shape as shown in FIG. In particular, the cross-sectional shape at the central portion S4 in the longitudinal direction of the main body 31 is a flat shape including the short axis J31 and the long axis J32. As will be described later, an implant main body 91 is disposed in the main body 31. Therefore, the posture within the main body 31 of the implant main body 91 can be controlled by making the main body 31 into a flat shape.

  The width of the internal space of the main body 31 (the length in the direction of the long axis J32) is designed to be substantially the same as the width of a main body portion 911 described later of the implant main body 91. Thereby, even if the implant main body 91 is moved, the frictional resistance with the internal space of the main body 31 is lowered, and unnecessary force is not applied to the implant main body 91, and the main body portion 911 is disposed in the main body 31 in a sufficiently expanded state. can do. However, the width of the internal space of the main body 31 (the length in the direction of the long axis J32) may be shorter than the width of the main body portion 911. Thereby, since the width | variety of the main body 31 can be restrained, it can be set as the less invasive puncture member 3. FIG.

  The flat shape of the main body 31 is not particularly limited, and for example, an oval shape, a convex lens shape in cross section, a rhombus with rounded corners, a rectangle with rounded corners (flat shape), and a central portion at both ends It can also be a spindle shape that is larger (expanded) than the portion.

  In the following, for convenience of explanation, as shown in FIG. 4B, the end located on the inner side (one end) in the direction of the long axis J32 is also referred to as “inner peripheral portion A1”, and is located on the outer side (the other end). The end portion to be performed is also referred to as “outer peripheral portion A2”, the surface facing upward is also referred to as “front surface A3”, and the surface facing downward is also referred to as “back surface A4”.

  As shown in FIG. 4B, a plane including both the center point of the arc of the central portion S4 and the center point of the cross-sectional shape with respect to the longitudinal direction of the main body 31 (the plane including the central axis of the main body 31) is defined as a plane f9. When the angle formed between the plane f9 and the short axis J31 at the central portion S4 is defined as an inclination angle θ1, the inclination angle θ1 is preferably an acute angle. By setting the inclination angle θ1 to an acute angle, an implant 9 described later can be disposed substantially parallel to the urethra, and the urethra can be more effectively supported. This effect will be described in detail later.

  In addition, as inclination | tilt angle (theta) 1, it is preferable that it is about 20-60 degrees, It is more preferable that it is 30-45 degrees, It is further more preferable that it is about 35-40 degrees. Thereby, the effect mentioned above improves further.

  The inclination angle θ1 preferably satisfies the above numerical range over the entire extending direction of the main body 31, but at least satisfies the above numerical range at the central portion S4 in the extending direction of the main body 31. The above effects can be exhibited. The “central portion S4” means at least a region including a portion located between the urethra and the vagina in a state where the puncture member 3 is punctured into the living body (a state where the main body 31 is disposed in the living body). . Moreover, in this embodiment, it can be said that the center part (center and the vicinity of both sides) between the anchors 81 and 82 is the center part S4 in a state where the anchors 81 and 82 are engaged with the puncture member 3 as described later. .

  It should be noted that markers are provided at both ends of the main body 31 at positions that are equal from the central portion S4 and project outside the living body in a state where the main body 31 is disposed on the living body (state shown in FIG. 22). Also good. Thereby, the position in the living body of center part S4 can be confirmed by comparing the position of both markers.

  The configuration of the main body 31 can be paraphrased as follows. That is, as shown in FIG. 4B, the main body 31 is formed such that the major axis J32 is inclined with respect to the arc central axis J5, and an extension line J32 between the arc central axis J5 and the major axis J32. It can be said that 'is configured to have an intersection P. In this case, the angle θ5 formed by the central axis J5 and the extension line J32 ′ is equal to the inclination angle θ1. In other words, as shown in FIG. 10, the main body 31 is an inner peripheral portion having a minimum radius of curvature r <b> 1 located at the inner peripheral edge in a plan view when viewed from the central axis J <b> 5 direction of the main body 31. A1 and an outer peripheral portion A2 located at the outer peripheral edge and having a maximum radius of curvature r2, as shown in FIG. 4B, the inner peripheral portion A1 and the outer peripheral portion A2 are separated in the direction of the central axis J5 ( It can be said that it is configured to be positioned.

  The main body 31 having such a shape is composed of two divided pieces (divided tubes) so as to be divided in the middle. That is, the main body 31 is divided into a tip split piece (first split tube) 32 and a base end split piece (second split tube) 33. The distal end divided piece 32 and the proximal end divided piece 33 have substantially the same length, and their boundary is located at the central portion S4.

  As shown in FIG. 5, the distal end divided piece 32 has a tube shape and has a distal end side opening 321 and a proximal end side opening 322. Further, the base end split piece 33 also has a tube shape and has a front end side opening 331 and a base end side opening 332. And the front-end | tip part of the base end split piece 33 is inserted in the base end part of the front end split piece 32, and, thereby, the front end split piece 32 and the base end split piece 33 are connected. As described above, by inserting the proximal end divided piece 33 into the distal divided piece 32, a step that may occur at the boundary between the divided pieces 32 and 33 is less likely to be caught on the living tissue, and the puncture member 3 can be smoothly punctured into the living body. Can be done. However, contrary to the present embodiment, the split pieces 32 and 33 may be connected by inserting the tip split piece 32 into the base end split piece 33.

  The connection state in which the divided pieces 32 and 33 are connected is maintained by the state maintaining mechanism 34. As shown in FIG. 6A, the state maintaining mechanism 34 exposes the holes 342a, 342b, 342c, an endless thread (connecting member) 341 inserted through the holes 342a, 342b, 342c, and the thread 341. Exposure holes (through holes) 345 and 346 to be exposed, and slits 347 connecting the exposure holes 345 and 346.

  The hole 342a is provided at the base end portion of the base end split piece 33 and closer to the inner peripheral portion A1 of the surface A3. On the other hand, the holes 342b and 342c are the base end portions of the tip split piece 32, and are provided facing the inner peripheral portion A1 of the front surface A3 and the back surface A4.

  The thread 341 is disposed in the main body 31, and is exposed to the outside of the main body 31 between the hole 342b and the hole 342c and between the hole 342a and the proximal end opening 332, respectively. By drawing the yarn 341 in this way, the connection state of the divided pieces 32 and 33 can be reliably maintained. Further, the exposure of the thread 341 to the outside of the main body 31 can be suppressed, and the thread 341 is hardly caught on the living tissue. Further, the overall length of the yarn 341 can be shortened as much as possible while allowing the yarn 341 to be cut as will be described later. Therefore, it is difficult for the thread 341 to be caught by the implant body 91 when the implant body 91 is inserted into the body 31. Further, as described above, since the holes 342a, 342b, and 342c are respectively disposed closer to the inner peripheral portion A1, the thread 341 is also disposed closer to the inner peripheral portion A1. Therefore, when the implant main body 91 is inserted into the main body 31, the thread 341 is hardly caught on the implant main body 91.

  The thread 341 is prepared, for example, as a thread with ends, and one end of the thread 341 is inserted into the main body 31 from the proximal end opening 332, pulled out of the main body 31 from the hole 342b, and inserted into the main body 31 from the hole 342c. It is obtained by pulling it out of the main body 31 from the hole 342a and finally tying it with the other end in the vicinity of the base end side opening 332. However, the position of the knot is not limited.

  Here, as shown in FIG. 6C, the hole 342 a has an axis inclined so that the outer opening is positioned closer to the base end side than the inner opening. On the other hand, as shown in FIG. 6B, the holes 342b and 342c each have an inclined axis so that the outer opening is located at the tip of the inner opening. Thereby, each hole 342a, 342b, 342c can be extended along the path | route of the thread | yarn 341, and the thread | yarn 341 becomes difficult to be caught in each hole 342a, 342b, 342c.

  The exposure holes 345 and 346 are provided to face the front surface A3 and the back surface A4 of the base end portion of the base end split piece 33, respectively. The site | part in which the exposure holes 345 and 346 are provided protrudes from the body surface in the state which has arrange | positioned the main body 31 in the biological body. The exposure holes 345 and 346 are located on the path of the yarn 341. Therefore, the thread 341 is exposed outside the main body 31 from the exposure holes 345 and 346. Further, the exposure holes 345 and 346 are connected by a slit 347 provided in the inner peripheral portion A1 along the circumferential direction of the main body 31.

  In such a state maintaining mechanism 34, the distal end split piece 32 and the proximal end split piece 33 are separable by cutting the thread 341. By setting it as such a structure, the front end division | segmentation piece 32 and the base end division | segmentation piece 33 can be made into the state which can be isolate | separated by simple operation. Moreover, since the cutting | disconnection of the thread | yarn 341 is visible, it can confirm easily that the front end division | segmentation piece 32 and the base end division | segmentation piece 33 became a state which can be isolate | separated.

  The thread 341 can be easily cut by providing the exposure holes 345 and 346 and the slit 347 as in the present embodiment. For example, a scissors having a pair of blades (first blade and second blade) are prepared, the first blade is inserted into the exposure holes 345 and 346, and the thread 341 is positioned between the pair of blades. . When the heel is closed, at least one of the first and second blades passes through the slit 347, the first and second blades overlap each other, and the thread 341 is cut in the process. Thus, by providing the exposure holes 345 and 346 and the slit 347, the thread 341 can be easily cut.

  Thus, in this embodiment, the slit 347 is provided, and this slit 347 is used as the passage path of the blade. Thereby, the deformation of the main body 31 due to the tension of the yarn 341 is prevented. Specifically, as shown in FIG. 7A, the passage route of the blade may be replaced by a slit 347 and configured by a hole 348. However, in this case, depending on the hardness of the main body 31, as shown in FIG. 7B, the hole 348 may be buckled and crushed by the tension of the thread 341, and the main body 31 may be deformed. On the other hand, in the slit 347, since the portions 347a and 347b sandwiching the slit 347 are in contact and stretched, as shown in FIG. Is prevented.

  As shown in FIG. 5, a pair of engagement holes 315 and 316 that engage with the anchor 81 are provided at the distal end portion of the main body 31. On the other hand, a pair of engagement holes 317 and 318 that engage with the anchor 82 are provided at the base end portion of the main body 31. Of these four engagement holes, the engagement holes 315 and 317 are provided in the inner peripheral portion A1, and the engagement holes 316 and 318 are provided in the outer peripheral portion A2.

  As described above, the main body 31 has a flat shape and is not easily crushed in the major axis direction, so that the separation distance between the inner peripheral portion A1 and the outer peripheral portion A2 is difficult to change. Further, the inner peripheral portion A1 and the outer peripheral portion A2 have large curvatures and are not easily deformed compared to the front surface A3 and the rear surface A4. Therefore, by providing the engagement holes 315 and 317 in the inner peripheral portion A1 and the engagement holes 316 and 318 in the outer peripheral portion A2, the engagement between the anchors 81 and 82 and the main body 31 is difficult to be released.

  Further, the separation distance between the engagement holes 315 and 316 and the central portion S4 and the separation distance between the engagement holes 317 and 318 and the central portion S4 are substantially equal. Thereby, the anchors 81 and 82 serve as markers, and the position of the central portion S4 of the main body 31 in the living body can be easily grasped.

  As shown in FIGS. 4 to 6, a plurality of through holes (side holes) 311 communicating with the inner cavity of the main body 31 are formed on the side surface of the main body 31. That is, each through hole 311 connects the outer peripheral surface and the inner peripheral surface of the main body 31, and the end of each through hole 311 communicates with the outer peripheral surface of the main body 31. The lumen of the main body 31 and the plurality of through-holes 311 function as a flow path through which liquid flows in a state where the puncture member 3 (medical tube assembly 10) has pierced (punctured) a living body. Specifically, for example, when a living body is punctured with the puncture member 3, if a blood vessel is mistakenly punctured, blood that has flowed out of the wound of the blood vessel flows into the lumen of the main body 31 from the through-hole 311. Flowing through the lumen, blood flashback occurs. The operator can grasp that the blood vessel has been erroneously punctured by visually recognizing the flashback of the blood. It can also be confirmed that a physiological saline has flowed into the bladder and the bladder or urethra has been accidentally punctured by the presence or absence of flashback of the physiological saline. The number of through holes 311 is not limited to a plurality, and may be one.

  Further, in the present embodiment, the through-hole 311 is formed in the central portion of the main body 31, that is, the proximal end portion of the distal end split piece 32 and the distal end portion of the proximal end split piece 33. When the implant main body 91 is placed in the living body, the central portion of the main body 31 is disposed between the urethra 1300 and the vagina 1400 (see FIG. 22), so that a through hole 311 is formed in the central portion of the main body 31. By doing so, it is possible to more reliably confirm erroneous puncture of the urethra due to the puncture member 3.

  Note that the formation region of the through hole 311 is not limited to the central portion of the main body 31, and may be the entire main body 31, for example.

  Further, the arrangement of the through holes 311 is not particularly limited, and is appropriately set according to various conditions. However, in the present embodiment, the arrangement is regularly, and specifically, the shaft of the main body 31 is arranged. They are arranged at equal intervals in the direction and at equal intervals in the circumferential direction. Moreover, each dimension, such as a diameter of the through-hole 311 and a pitch, is not specifically limited, It sets suitably according to various conditions. In addition, as another arrangement | positioning of the through-hole 311, the case where it arrange | positions irregularly etc. are mentioned, for example, when arrange | positioning helically.

  The shape of the through hole 311 is not particularly limited, but in the present embodiment, the through hole 311 has a circular shape in plan view. Examples of the other shape of the through hole 311 include, for example, an elliptical shape and a polygonal shape such as a quadrangle in plan view.

  A needle body 35 is provided at the tip of the main body 31 as described above. As shown in FIG. 5, the needle body 35 has a tapered needle tip 351 and a proximal end portion 352 provided on the proximal end side of the needle tip 351. Then, the base end portion 352 is inserted into the main body 31, whereby the needle body 35 is detachably held on the main body 31. Note that the base end portion 352 is fitted into the main body 31 with a force that can prevent unintentional detachment of the needle body 35 from the main body 31. The needle body 35 may be configured integrally with the main body 31.

  In addition, the proximal end portion 352 is provided with an engaging portion 353 that engages with the distal end portion 711 of the insertion portion 71. The engaging portion 353 is configured by a concave portion, and the distal end portion 711 is positioned in the engaging portion 353 in the inserted state in which the puncture member 3 is inserted into the inserting portion 71. By providing the engagement portion 353, the displacement of the needle body 35 with respect to the insertion portion 71 is suppressed, and the puncture member 3 can be punctured into the living body more smoothly.

  Note that when the cross-sectional shape of at least the tip portion 711 of the insertion portion 71 is flat, the cross-sectional shape of the engaging portion 353 is formed in accordance with the cross-sectional shape of the tip portion 711. That is, it is preferable that the cross-sectional shape of the engaging portion 353 is also flat. Thereby, in the state which the engaging part 353 and the front-end | tip part 711 engaged, the flat shape of the engaging part 353 and the front-end | tip part 711 overlaps. By this overlap, the sheath 30 is restricted from rotating around the axis with respect to the insertion portion 71.

  The puncture member 3 has been described above. The center angle θ4 of the puncture member 3 is not particularly limited and is appropriately set according to various conditions. As will be described later, the needle body 35 enters the body from one of the buttocks of the patient, and the urethra It is set so that it can pass between the vagina and protrude from the other buttocks. Specifically, the central angle θ4 is preferably 150 to 270 °, more preferably 170 to 250 °, and further preferably 190 to 230 °.

  Moreover, as a constituent material of the main body 31 and the needle body 35, a hard material which maintains a shape and internal space (lumen) in the state inserted in the body is preferable. Examples of such a hard material include various resin materials such as polyethylene, polyimide, polyamide, polyester elastomer, and polypropylene, and various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, and the like. . In addition to employing a hard material as the configuration of the main body 31 and the needle body 35, when a material other than the hard material is employed, the wall can be reinforced by a reinforcing member. For example, by embedding a high-strength braided body in the wall, the shape and the internal space can be maintained while being inserted into the body. As another example of the reinforcing member, by embedding a spiral object in the wall of the main body 31, it is possible to provide flexibility while maintaining the internal space to the extent that the insert can slide.

  It is preferable that the main body 31 has light transmittance and the inside can be visually recognized from the outside. Thereby, for example, it is possible to confirm whether the distal end portion 711 of the insertion portion 71 inserted inside is engaged with the engagement portion 353 or whether the thread 341 is not cut. Further, flashback of blood or the like described later can be easily visually confirmed.

  The puncture member 3 (main body 31) described above and the insertion portion 71 inserted into the main body 31 constitute the medical tube assembly 10, and in the puncture device 1, these are in the state of the medical tube assembly 10. Use begins.

  The number and arrangement of the holes (342a, 342b, 342c) through which the thread 341 passes are not particularly limited as long as the connection state between the distal end divided piece 32 and the proximal end divided piece 33 can be maintained by the thread 341. Moreover, the thread | yarn 341 does not need to be endless shape, and the end shape which has one end and the other end may be sufficient as it. For example, an end-shaped thread may be prepared, and one end thereof may be a loop that passes through the hole 342a and the proximal end opening 332, and the other end may be a loop that passes through the holes 342b and 342c. Further, the thread 341 includes a string, a band, and the like that can be used in the same manner as the thread 341.

(anchor)
As shown in FIG. 8A, the anchor (second anchor) 81 protrudes from the base 811 having an insertion hole 812 through which the main body 31 is inserted, and engages with the pair of engagement holes 315 and 316. A pair of claw portions 813 and 814 is provided. The cross-sectional shape of the insertion hole 812 corresponds to the cross-sectional shape of the main body 31. Therefore, in a state where the puncture member 3 is inserted through the insertion hole 812, the rotation of the anchor 81 with respect to the puncture member 3 is restricted, and these positional relationships are appropriately maintained. When the puncture member 3 is inserted into the insertion hole 812 and the puncture member 3 is pushed forward with respect to the anchor 81, the claw portions 813 and 814 engage with the engagement holes 315 and 316 as shown in FIG. As a result, the anchor 81 is engaged with the tip split piece 32. In the engaged state, the base portion 811 is located on the proximal end side with respect to the claw portions 813 and 814. As described above, when the puncture member 3 is inserted through the insertion hole 812, the rotation of the anchor 81 with respect to the puncture member 3 is restricted, so that the engagement between the claw portions 813 and 814 and the engagement holes 315 and 316 is ensured. Can be expressed.

  Similarly, as shown in FIG. 9A, the anchor (first anchor) 82 includes a base portion 821 having an insertion hole 822 through which the main body 31 is inserted, a base portion 821, and a pair of engagement holes 317, 318. It has a pair of claw parts 823 and 824 to be engaged. The cross-sectional shape of the insertion hole 822 corresponds to the cross-sectional shape of the main body 31. Therefore, in a state where the puncture member 3 is inserted through the insertion hole 822, the rotation of the anchor 82 with respect to the puncture member 3 is restricted, and these positional relationships are appropriately maintained. When the puncture member 3 is inserted into the insertion hole 812 and the puncture member 3 is pushed forward against the anchor 82, the claws 823 and 824 engage with the engagement holes 317 and 318 as shown in FIG. 9B. As a result, the anchor 82 is engaged with the base end split piece 33. In the engaged state, the base portion 821 is located on the tip side of the claw portions 823 and 824. As described above, when the puncture member 3 is inserted into the insertion hole 822, the rotation of the anchor 82 with respect to the puncture member 3 is restricted, so that the engagement between the claw portions 823 and 824 and the engagement holes 317 and 318 is ensured. Can be expressed.

  The constituent materials of the anchors 81 and 82 are not particularly limited, and for example, various resin materials can be used.

(flame)
The frame (restricting portion) 2 rotatably holds the operation member 7 to which the puncture member 3 is attached, and fixes the insertion tool 6 and the anchors 81 and 82 in a detachable manner. The frame 2 has a function of determining a puncture route of the needle body 35 when the puncture member 3 (medical tube assembly 10) punctures a living tissue.

  Specifically, the frame 2 is configured such that when the puncture member 3 is rotated and punctures a living tissue, the needle tip 351 of the needle body 35 is located farther from the rotation center of the puncture member 3 than the urethra insertion member 4. The positional relationship among the puncture member 3, the urethral insertion member 4 and the vaginal insertion member 5 is determined so as to pass through, that is, between the urethral insertion member 4 and the vaginal insertion member 5 without colliding with them. Yes.

  As shown in FIGS. 1 and 2, the frame 2 guides the bearing portion 21 that supports the shaft portion 73 of the operation member 7 and the puncture member 3 and detachably holds the first and second anchors 81 and 82. A guide portion (holding portion) 22, a connecting portion 23 that connects the bearing portion 21 and the guide portion 22, and a fixing portion 24 to which the insertion tool 6 is fixed.

  The bearing portion 21 is located on the proximal end side of the puncture device 1 and extends in a direction substantially orthogonal to the axis J1. A through hole 211 is formed on the shaft J1 of the bearing portion 21, and the shaft portion 73 is rotatably inserted into the through hole 211. As a result, the operation member 7 is supported on the frame 2 in a state of being rotatable about the axis J1.

  The guide portion 22 is located on the distal end side of the puncture device 1 and is disposed to face the bearing portion 21. As shown in FIG. 10, the guide portion 22 is formed with a substantially C-shaped guide groove 221 that accommodates the puncture member 3 and guides the puncture member 3. Further, as shown in FIG. 11, in the state of being placed in the guide groove 221, the puncture member 3 has the back surface A4 positioned on the distal end side and the surface A3 positioned on the proximal end side.

  Moreover, the guide part 22 is holding the anchors 81 and 82 so that attachment or detachment is possible. The anchor 82 is held facing the front end side opening 222 so that the insertion hole 822 is continuous with the guide groove 221, and the anchor 81 is guided by the guide groove 221 so that the insertion hole 812 is continuous with the guide groove 221. Is held opposite to the base end side opening 223.

  In the initial state, the main body 31 is inserted into the insertion hole 822 of the anchor 82, and the needle body 35 protrudes from the guide portion 22. When the operation member 7 is rotated, the puncture member 3 gradually protrudes from the guide portion 22, and finally, the needle body 35 enters the guide portion 22 through the proximal end opening 223 as shown in FIG. . In this process, the puncture member 3 passes through the insertion hole 812 of the anchor 81 on the distal end side of the puncture member 3, and the claw portions 813 and 814 engage with the engagement holes 315 and 316. On the other hand, the claw portions 823 and 824 are engaged with the engagement holes 317 and 318 on the proximal end side of the puncture member 3. Thereby, the anchors 81 and 82 are engaged with the puncture member 3.

  The connecting portion 23 connects the bearing portion 21 and the guide portion 22. Further, the connecting portion 23 has a rod shape extending substantially parallel to the axis J1. The connecting portion 23 also functions as a grasping portion, and an operator can use the puncture apparatus 1 by grasping the connecting portion 23.

  The fixed portion 24 is disposed to face the connecting portion 23 via the axis J1. As shown in FIG. 13, the fixing portion 24 has a concave portion 243 into which a support portion 60 described later of the insertion tool 6 is fitted, and a male screw 244. The insertion tool 6 can be fixed to the fixing portion 24 by fitting the supporting portion 60 into the recess 243 and further tightening the male screw 244 into a female screw (not shown) of the supporting portion 60.

(Insert tool)
As shown in FIGS. 1 and 14, the insertion tool 6 includes a urethral insertion portion (second insertion portion) 41 to be inserted into the urethra, and a vaginal insertion portion (first insertion portion) 51 to be inserted into the vagina. And a support portion 60 that supports the urethral insertion portion 41 and the vaginal insertion portion 51. As described above, the insertion tool 6 includes the urethral insertion member 4 and the vaginal insertion member 5, the urethral insertion member 4 includes the urethral insertion portion 41, and the vaginal insertion member 5 includes the vaginal insertion portion 51. The support portion 60 includes a support portion 40 that is provided in the urethral insertion member 4 and supports the urethral insertion portion 41, and a support portion 50 that is provided in the vaginal insertion member 5 and supports the vaginal insertion portion 51. In the insertion tool 6, the urethral insertion member 4 and the vagina insertion member 5 are detachable via the support portions 40 and 50. Hereinafter, the urethral insertion member 4 and the vaginal insertion member 5 will be described in order.

-Urethral insertion member-
The urethral insertion member 4 has a long urethral insertion portion 41 that is inserted into the urethra halfway and a support portion 40 that supports the urethral insertion portion 41. In the following description, for convenience of explanation, a portion located in the urethra (including the bladder) in the wearing state is also referred to as an “insertion portion 411”, and is a portion exposed outside the body from the urethral opening in the wearing state. A portion up to the support portion 40 is also referred to as a “non-insertion portion 412”.

  The urethral insertion portion 41 has a straight tubular shape with a rounded tip. In addition, a balloon 42 that can be expanded / contracted and a urine discharge portion 47 are provided at the distal end portion of the insertion portion 411. The balloon 42 functions as a restricting portion that restricts the axial position of the urethral insertion member 4 in the urethra. Specifically, when the puncture device 1 is used, the balloon 42 is expanded after being inserted into the patient's bladder. And the position of the urethral insertion member 4 with respect to a bladder and a urethra is fixed by the expanded balloon 42 being caught in a bladder neck. On the other hand, the urine discharge unit 47 is used to discharge urine in the bladder.

  The balloon 42 passes through the urethral insertion portion 41 and is connected to a balloon port 43 provided at the proximal end portion thereof. A balloon expansion device such as a syringe can be connected to the balloon port 43. When the working fluid (liquid such as physiological saline, gas, etc.) is supplied from the balloon expanding device to the balloon 42, the balloon 42 expands. Conversely, when the working fluid is extracted from the balloon 42 by the balloon expanding device, the balloon 42 contracts. To do. In FIG. 14, the state in which the balloon 42 is deflated is indicated by a two-dot chain line, and the state in which the balloon 42 is expanded is indicated by a solid line.

  On the other hand, the urine discharge part 47 is provided with a discharge hole 471 that communicates the inside and outside of the urine discharge part 47. The urine discharge part 47 passes through the urethra insertion part 41 and is connected to a urine discharge port 48 provided at the base end part thereof. Therefore, urine introduced from the discharge hole 471 can be discharged from the urine discharge port 48.

  The balloon 42 and the urine discharge part 47 can be constituted by, for example, a double lumen.

  A plurality of suction holes 44 are formed in the middle of the insertion portion 411. The plurality of suction holes 44 are arranged over the entire area in the circumferential direction of the urethral insertion portion 41. Each suction hole 44 is connected to a suction port 45 provided at the base end portion through the urethra insertion portion 41. A suction device such as a pump can be connected to the suction port 45. When the suction device is operated with the urethra insertion part 41 inserted into the urethra, the urethra wall can be adsorbed and fixed to the urethra insertion part 41. In this state, when the urethra insertion part 41 is pushed into the distal end side (inside the body), the urethra is also pushed together, and for example, the bladder can be shifted to a position that does not overlap the puncture path of the puncture member 3. The puncture route can be secured. Therefore, the puncture member 3 can be punctured accurately and safely. The number of suction holes 44 is not particularly limited, and may be one, for example. The arrangement of the suction holes 44 is not particularly limited, and may be formed only in a part of the circumferential direction of the urethral insertion portion 41, for example.

  Further, a marker 46 for confirming the insertion depth of the urethra insertion part 41 into the urethra is provided at the boundary between the insertion part 411 and the non-insertion part 412. The marker 46 is located at the urethral opening when the urethral insertion portion 41 is inserted into the urethra and the balloon 42 is located in the bladder. Thereby, the insertion depth to the urethra of the insertion part 411 can be confirmed easily. The marker 46 only needs to be visually recognized from the outside, and can be constituted by, for example, a colored portion, an uneven portion, or the like. In addition, it may replace with the marker 46 and may provide the scale in which the distance from the front-end | tip of the urethral insertion part 41 was described.

  The length of the insertion portion 411 is not particularly limited, and is appropriately set depending on the length of the patient's urethra, the shape of the bladder, and the like. Since the length of a general female urethra is about 30 to 50 mm, it is more preferably about 50 to 100 mm.

  The length of the non-insertion portion 412 (the separation distance between the urethral opening and the support portion 40) is not particularly limited, but is preferably about 100 mm or less, and more preferably about 20 to 50 mm. Thereby, the non-insertion part 412 can be made into appropriate length, and operativity improves. If the length of the non-insertion portion 412 exceeds the upper limit, depending on the configuration of the frame 2, the center of gravity of the puncture device 1 is greatly separated from the patient, and the stability of the puncture device 1 in the worn state is reduced. There is a case.

  The constituent material of the urethral insertion member 4 is not particularly limited. For example, various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, and various resin materials can be used.

  Here, the inclination angle θ2 of the plane f9 (plane f1) with respect to the plane f2 orthogonal to the axis J2 of the urethra insertion part 41 is preferably about 20 to 60 °, more preferably about 30 to 45 °, More preferably, it is about 35-40 degrees. In other words, the main body 31 is preferably placed in the body so that the angle between the plane f9 and the plane perpendicular to the axis of the urethra is about 20 to 60 °, and the body 31 is about 30 to 45 °. It is more preferable to be placed in the body so as to be about 35 to 40 °. Thereby, the puncture of the puncture member 3 can be easily performed, and the puncture distance by the puncture member 3 can be further shortened.

  More specifically, by setting the inclination angle θ2 within the above range, the puncture member 3 can broadly grasp the left and right closure holes 1101 and 1102 of the pelvis 1100 in a plane as shown in FIG. It is possible to secure a wide puncture space for the puncture member 3. That is, the puncture member 3 can be punctured in a relatively vertical direction with respect to the closing holes 1101 and 1102 in a state where the patient is in a predetermined body position (crushed stone position). Therefore, the puncture member 3 can be punctured easily. In addition, since the puncture member 3 is punctured in a relatively vertical direction with respect to the closure holes 1101 and 1102, the needle body 35 of the puncture member 3 passes through the shallow portion of the tissue. You can pass between them at a shorter distance. Therefore, as shown in FIG. 15 (b), the puncture member 3 can pass through the closure holes 1101 and 1102 near the pubic joint 1200, preferably through the safety zone S5. Since the safety zone S5 is a site where there are few nerves and blood vessels to avoid damage, the puncture member 3 can be punctured safely. Therefore, it becomes less invasive and can reduce the burden on the patient. As described above, by setting the inclination angle θ2 within the above range, the patient can be punctured with the puncture member 3 more appropriately. In addition, puncturing at the above-described angle makes it easy to target the tissue between the middle urethra and the vagina that indicate the middle portion in the length direction of the urethra. Between the middle urethra and the vagina is a position suitable as a site for implanting the implant 9 and treating urinary incontinence.

  On the other hand, when the inclination angle θ2 is less than the lower limit value or exceeds the upper limit value, the puncture member 3 planarly closes the closing holes 1101 and 1102 depending on individual differences in the patient, the posture during the procedure, and the like. There are cases where it is not possible to capture widely or the puncture route cannot be shortened sufficiently.

  More preferably, the puncture between the middle urethra and the vagina is facilitated by puncturing the urethra or the vagina, and both the urethra and the vagina in a position shifted so as to be pushed into the body. For example, the urethra insertion member 4 and / or the vagina insertion member 5 is inserted in an appropriate position, and a suction hole 44, which will be described later, is provided in the urethra and the vagina. 59, after the urethra and / or vagina is adsorbed, the urethral insertion member 4 and / or the vagina insertion member 5 can be further moved to the inside of the body along the respective axes to a predetermined position. In this manner, the main body 31 is punctured perpendicularly to the left and right closure holes 1101 and 1102 of the pelvis in a state where the position is shifted so as to push at least one of the urethra and the vagina into the inside of the body. The passage can be formed at a position suitable for the above.

  The trajectory of the main body 31 is set so as to pass through the safety zones S5 of the left and right closure holes 1101 and 1102 of the pelvis, and at least one of the urethra and vagina is inward of the body so that the trajectory is located between the middle urethra and the vagina. It is preferable to shift and puncture the main body 31 along the track to form a passage.

-Vaginal insertion member-
As shown in FIGS. 1 and 14, the vaginal insertion member 5 includes a long vaginal insertion portion (first insertion portion) 51 that is inserted into the vagina partway and a support portion that supports the vaginal insertion portion 51. 50. In the following, for convenience of explanation, the part located in the vagina in the wearing state is also referred to as “insertion part 511”, and is a part exposed from the vaginal opening to the outside of the body in the wearing state up to the support part 50. This portion is also referred to as “non-insertion portion 512”.

  The insertion part 511 has a long shape. Further, the insertion portion 511 extends with an inclination with respect to the insertion portion 411 so that the distal end side is separated from the insertion portion 411. By tilting the insertion portion 511 with respect to the insertion portion 411, the positional relationship between the insertion portions 411 and 511 can be made closer to the positional relationship between the urethra and the vagina than when the insertion portion 511 is not tilted. Therefore, the puncture device 1 is more stably held by the patient in the wearing state, and the burden on the patient is reduced. Although it does not specifically limit as inclination-angle (theta) 3 with respect to the insertion part 411 of the insertion part 511, For example, it is preferable that it is about 0-45 degrees, and it is more preferable that it is about 0-30 degrees. Thereby, the said effect can be exhibited more notably. On the other hand, when the inclination angle θ3 is less than the above lower limit value or exceeds the above upper limit value, the vagina and urethra deform unnaturally in the wearing state depending on individual differences of patients, posture during the procedure, etc. However, the puncture device 1 may not be stably held.

  As shown in FIG. 16, the insertion portion 511 has a flat shape that is crushed in the vertical direction of the puncture device 1 (the arrangement direction of the urethra and vagina). Further, the insertion portion 511 has a central portion having a substantially constant width and a rounded tip portion. Although it does not specifically limit as length L2 of the insertion part 511, It is preferable that it is about 20-100 mm, and it is more preferable that it is about 30-60 mm. Further, the width W1 of the insertion portion 511 is not particularly limited, but is preferably about 10 to 50 mm, and more preferably about 20 to 40 mm. Further, the thickness of the insertion portion 511 is not particularly limited, but is preferably about 5 to 25 mm, and more preferably about 10 to 20 mm. By adopting such length × width × thickness, the insertion portion 511 has a shape and size suitable for a general vagina. Therefore, the stability of the puncture device 1 in the mounted state is increased, and the burden on the patient is reduced.

  A plurality of bottomed recesses 53 are formed on the upper surface (surface on the urethra insertion portion 41 side) 511a of the insertion portion 511. In addition, the number of the recessed parts 53 is not specifically limited, For example, one may be sufficient. In addition, one suction hole 59 is provided on the bottom surface of each recess 53, and each suction hole 59 passes through the insertion portion 511 and is connected to a suction port 54 provided at the base end portion thereof. . The suction port 54 is provided so as to be located outside the living body in the mounted state. A suction device such as a pump can be connected to the suction port 54. When the suction device is operated with the insertion portion 511 inserted into the vagina, the vaginal front wall, which is the upper surface of the vagina wall, is inserted into the insertion portion 511. Adsorbed and fixed. When the vagina insertion portion 51 is pushed into the distal end (inside the body) with the vagina wall being adsorbed and fixed, the vagina wall can be pushed together with this. Therefore, the arrangement and shape of the vagina wall can be adjusted, the puncture route of the puncture member 3 can be secured, and the puncture of the puncture member 3 can be performed accurately and safely.

  The region S2 in which the plurality of recesses 53 are formed is disposed to face the region S1. And the needle point of the puncture member 3 passes between these area | regions S1 and S2. As described above, the urethra 1300 that is the lower surface of the urethral wall is adsorbed by the insertion portion 411 in the region S1, and the vagina wall is adsorbed by the insertion portion 511 in the region S2, so that the urethral wall is between the regions S1 and S2. And the vaginal wall are more widely separated. Therefore, the puncture member 3 can be punctured more safely by passing the puncture member 3 through such a region.

  The region S2 extends over substantially the entire width direction of the upper surface 511a. Although it does not specifically limit as width W2 of area | region S2, It is preferable that it is about 9-49 mm, and it is more preferable that it is about 19-39 mm. Thereby, the vaginal wall can be more reliably adsorbed to the insertion portion 511 without being greatly affected by the shape of the vagina wall. In particular, as shown in FIG. 17A, some patients may have a vagina 1400 having a shape in which a part of the anterior vaginal wall 1410 hangs into the vagina. Even in such a case, if the width W2 is set as described above, as shown in FIG. 17B, not only the sagging portion but also the portions on both sides of the sagging portion can be reliably sucked. Therefore, the front wall of the vagina can be more reliably separated from the urethra without being affected by the shape of the vagina. In particular, in this embodiment, since the insertion portion 511 has a flat shape, the front wall of the vagina can be adsorbed so as to be further away from the urethra, and the living tissue between the urethra wall and the vagina wall is more widely spread. be able to.

  In addition, the insertion unit 511 is provided with a marker (puncture position confirmation unit) 57 that can confirm the puncture route of the puncture device 1, that is, the vaginal wall present on the upper surface of the position where the marker 57 exists. The puncture device can be fixed to puncture between the urethral walls. Therefore, the operability and safety of the insertion tool 6 are improved. The marker 57 is provided at least on the lower surface 511b of the insertion portion 511. Since the lower surface 511b is a surface that faces the vaginal opening side and is visible to the operator through the vaginal opening in the inserted state, by providing the marker 57 on the lower surface 511b, the puncture route of the puncture apparatus 1 can be more reliably performed. Can be confirmed. Further, the insertion depth of the insertion portion 511 into the vagina can also be confirmed. Note that the marker 57 only needs to be visible from the outside, and can be configured by, for example, a colored portion, an uneven portion, or the like.

  The non-insertion portion 512 has a thin rod shape extending substantially parallel to the urethral insertion portion 41. The separation distance D between the non-insertion portion 512 and the urethral insertion portion 41 is not particularly limited, but is preferably about 5 to 40 mm in accordance with the separation distance between the urethral opening and the vaginal opening in a general woman. .

  The length of the non-insertion portion 512 (the distance between the vaginal opening and the support portion 50) is not particularly limited, but is preferably about 100 mm or less, more preferably about 20 to 50 mm. Thereby, the non-insertion part 512 can be made into suitable length, and operativity improves. If the length of the non-insertion portion 512 exceeds the above upper limit value, the center of gravity of the puncture device 1 is greatly separated from the patient depending on the configuration of the frame 2 and the stability of the puncture device 1 in the worn state is lowered. There is a case.

  The support portion 50 is provided with a male screw 501, and the support portions 40 and 50 are fixed to each other by tightening the male screw 501 into a female screw (not shown) of the support portion 40.

The constituent material of the vaginal insertion member 5 is not particularly limited. For example, as with the urethra insertion member 4, various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, and various resin materials are used. Can do.
The configuration of the puncture device 1 has been described above.

  In the puncture device 1, the urethral insertion member 4 and the vagina insertion member 5 constituting the insertion tool 6 are configured to be detachable. However, the present invention is not limited to this, and the urethral insertion member 4 and the vagina insertion member 5 are detachable. It may be impossible.

  Further, in the puncture device 1, the urethral insertion portion 41 is fixed to the support portion 40, but the present invention is not limited to this, and the urethral insertion portion 41 is fixed to the support portion 40 and the support portion 40. It may be possible to select a state in which it can slide in the axial direction. Specifically, for example, if the screw provided in the support part 40 is loosened, the urethra insertion part 41 becomes slidable with respect to the support part 40, and if the screw is tightened, the urethra insertion part 41 becomes the support part. 40 may be in a fixed state. According to this configuration, since the length of the non-insertion portion 412 can be adjusted, the insertion tool 6 is more convenient to use. This also applies to the vaginal insertion portion 51.

  In the puncture apparatus 1, each part is fixed to the frame 2 so that the inclination angle θ2 is constant, but the present invention is not limited to this, and the inclination angle θ2 may be variable. Thereby, since inclination-angle (theta) 2 can be adjusted according to a patient, it becomes the puncture apparatus 1 which is more convenient.

2. Next, a method of using the puncture device 1 will be described. Prior to that, an implant 9 used with the puncture device 1 will be described.

  The implant (living tissue support indwelling product) 9 shown in FIG. 18 is an implantable device for treating female urinary incontinence, that is, a device that supports the urethra, for example, the urethra is about to move to the vaginal wall side. Sometimes it is a device that supports the urethra so as to restrict its movement away from the vaginal wall. As this implant 9, for example, a long object having flexibility can be used.

  The implant 9 includes an implant main body (strip-shaped elongated object) 91 and a bag-shaped packaging material 92 that accommodates the implant main body 91. The implant body 91 has a body portion 911 and a band 912 connected to one end of the body portion 911. By providing the implant 9 with the packaging material 92, contamination of the implant body 91 can be effectively prevented. Note that a guide wire, string, thread, or the like may be used instead of the band 912.

  The main body portion 911 has a net shape, and the entire shape thereof is a belt shape. In addition, the main-body part 911 can be comprised, for example by what crossed the linear body and knit in the net shape, ie, a net-like braided body. Examples of the linear body include a circular cross section, a flat cross section, that is, a strip.

  The constituent materials of the main body 911, the band 912, and the packaging material 92 are not particularly limited. For example, various resin materials, fibers, and the like having biocompatibility such as polypropylene, polyester, and nylon can be used. .

  The implant 9 is not limited to the net-like one as long as the same effect can be exhibited. The implant 9 and the sheath 30 constitute a pelvic treatment kit.

  Next, an operation procedure of the puncture device 1, that is, a procedure hand when the implant 9 is embedded in a living body will be described.

  First, the patient is placed in a crushed position on the operating table, and the insertion tool 6 is attached to the patient as shown in FIG. Specifically, first, the urethral insertion portion 41 of the urethral insertion member 4 is inserted into the urethra 1300 of the patient. At this time, the insertion depth is confirmed by the marker 46, and the balloon 42 is placed in the bladder 1310. The urethra 1300 is corrected to the predetermined shape by the urethra insertion part 41 having a predetermined shape. In the case of the present embodiment, the urethra is straightened by the straight urethra insertion part 41.

  Next, the balloon 42 is expanded, and urine is discharged from the bladder 1310 through the discharge hole 471 as necessary. Further, the vaginal insertion part 51 of the vaginal insertion member 5 is inserted into the patient's vagina 1400. At this time, the puncture position is confirmed with the marker 57 and inserted to an appropriate depth. Then, the support portions 40 and 50 are fixed by operating the male screw 501. Thereby, mounting | wearing of the insertion tool 6 to a patient is completed. In this state, the non-insertion parts 412 and 512 are separated from each other, and the support part 60 is separated from the body surface between the urethral opening and the vaginal opening, and the body surface is exposed. In addition, when the insertion portion 511 and the anterior wall of the vagina are separated from each other and a gap (space) is formed between them, the living body between the urethra and the vagina is determined from the body surface between the urethra and the vagina. A space S3 for piercing the tissue with the syringe is formed.

  Next, a suction device is connected to the suction ports 45 and 54, the suction device is operated, the urethra 1300 is adsorbed to the urethra insertion portion 41, and the vagina front wall is adsorbed to the vaginal insertion portion 51. For example, if the urethra 1300 is properly adsorbed by the urethra insertion portion 41, the suction hole 44 is blocked by the urethra wall, and thus suction from the suction port 45 is stopped or weakened. Similarly, if the anterior vagina wall is properly adsorbed by the vagina insertion portion 51, the suction hole 59 is blocked by the vagina wall, so that suction from the suction port 54 is stopped or weakened. For this reason, the surgeon properly adsorbs the urethra 1300 and the anterior wall of the vagina to the urethra insertion part 41 and the vagina insertion part 51 from the state of suction from the suction ports 45 and 54 (for example, the magnitude of sound generated by suction). You can check whether or not. The insertion tool 6 may have a confirmation mechanism that mechanically confirms the suction state. The confirmation mechanism is not particularly limited as long as the adsorption state can be confirmed. For example, the confirmation mechanism is based on a flow rate measurement unit (negative pressure gauge) that measures a flow rate from the suction port 54 and a measurement result from the flow rate measurement unit. It can be set as the structure which has a judgment part which judges whether adsorption | suction is performed correctly.

  Next, liquid peeling is performed. Specifically, as shown in FIG. 19 (b), the puncture needle of the syringe 2000 is punctured into the vaginal front wall 1410 through the space (space S3) between the insertion portion 511 and the vaginal front wall 1410, and the urethra. A liquid such as physiological saline or a local anesthetic is injected into the living tissue between 1300 and the vagina 1400 (between the regions S1 and S2). As a result, the living tissue between the regions S1 and S2 expands, the urethra 1300 is pressed against the urethral insertion portion 41, and the vaginal front wall 1410 is pressed against the vaginal insertion portion 51.

  Here, it is preferable to continue the suction from the suction holes 44 and 59 even during liquid peeling. When the urethra 1300 is pressed against the urethra insertion part 41 by liquid separation, the urethra 1300 is further adsorbed by the urethra insertion part 41, and thus suction from the suction port 45 is stopped or weakened. Similarly, when the anterior vagina wall is pressed against the vagina insertion portion 51, the anterior vagina wall is further adsorbed by the vagina insertion portion 51, so that suction from the suction port 45 is stopped or weakened. Therefore, the operator can confirm whether or not the liquid separation has been properly performed based on the suction state from the suction ports 45 and 54.

  Liquid separation is performed so that the urethra 1300 and the anterior wall of the vagina are sufficiently separated from each other, and then the frame 2 is fixed to the insertion tool 6 as shown in FIG. Thereby, the puncture apparatus 1 will be in the state with which the patient was mounted | worn. In this state, the positional relationship between the pelvis 1100 and the puncture device 1 is as shown in FIG.

  Next, for example, while holding the connecting portion 23 of the frame 2 with one hand, the connecting portion 72 of the operating member 7 is held with the other hand, and the operating member 7 is held back as shown in FIG. Rotate clockwise. Thereby, the needle body 35 of the puncture member 3 punctures the body surface H of the right buttocks of the patient or a portion (first portion) in the vicinity thereof, and enters the body. After passing through the other closing hole 1102 in order with the 1400, it projects out of the body surface H of the left buttocks or its vicinity (second part) and finally retracts into the guide part 22. (See FIG. 23).

  Thereby, the puncture member 3 is disposed in the living body, and the anchors 81 and 82 are engaged with the main body 31 according to the principle described above. Therefore, when the anchor 82 abuts on the body surface H, further insertion of the proximal end portion of the main body 31 into the living body is restricted. In other words, it is possible to ensure that the base end of the main body 31 is exposed to the outside of the living body.

  Next, when a living body is punctured with the puncture member 3 (medical tube assembly 10), for example, a portion that is not desired to be damaged, such as a blood vessel, a bladder, or a urethra, is punctured with the puncture member 3 to confirm whether or not it is damaged. To do.

  First, when a blood vessel is damaged, blood flows into the lumen of the main body 31 from the through hole 311 and flows through the lumen. The surgeon can recognize that the blood vessel is damaged by visually recognizing the flashback of the blood.

  In order to confirm whether or not the bladder or urethra is injured, for example, physiological saline is flowed into the bladder using the urine drainage port 48 of the urethra insertion member 4 or other instruments, and abdominal pressure is applied. When the bladder or urethra is injured, the physiological saline flows into the lumen of the main body 31 from the through hole 311 and flows through the lumen. The surgeon can grasp that the bladder and urethra are injured by visually recognizing the flashback of the physiological saline.

  In addition, when the blood vessel, the bladder, the urethra, etc. are damaged, a predetermined treatment is performed, and when not damaged, the process proceeds to the next step. In this way, the procedure can be performed safely.

  Next, the operation member 7 is rotated clockwise in FIG. At this time, the puncture member 3 also tries to rotate counterclockwise together with the operation member 7, but when the anchor 81 comes into contact with the body surface H, further rotation (movement) is prevented. Therefore, the insertion portion 71 is removed from the puncture member 3 and the living body while maintaining the state where the tip of the main body 31 is exposed to the outside of the living body. Next, puncture device 1 (member other than puncture member 3) is removed from the patient, and needle body 35 is removed from main body 31. Thereby, as shown in FIG.22 (b), only the main body 31 will be in the state arrange | positioned in the biological body. The main body 31 is disposed in the living body in a state where both the distal end side opening (leading end portion) and the proximal end side opening (base end portion) are exposed to the outside of the living body.

  Next, the position of the main body 31 is adjusted as necessary. Specifically, the main body 31 is shifted to the proximal end side or the distal end side, and the positions of the anchors 81 and 82 with respect to the living body are symmetrical. Thereby, the center part S4 of the main body 31 can be positioned between the urethra 1300 and the vagina 1400 more reliably. In this state, as shown in FIG. 24, the central portion S4 is arranged such that its width direction (long axis J32 direction) W is substantially parallel to the urethra 1300. That is, the width direction W of the urethra 1300, which is corrected by inserting the urethra insertion member 4 and the central portion S4, is located substantially in parallel.

  Next, the implant main body 91 is inserted into the main body 31 while being taken out from the packaging material 92, and as shown in FIG. 25 (a), the band 912 is projected from the proximal end opening and the distal end opening of the main body 31; To do. Thus, contamination of the implant main body 91 can be prevented by accommodating the implant main body 91 in the packaging material 92 until immediately before being disposed in the main body 31. As described above, since the main body 31 has a flat shape, the posture of the main body portion 911 follows this flat shape. That is, as shown in FIG. 25 (b), the main body portion 911 is arranged in the main body 31 so that the width direction thereof coincides with the width direction of the main body 31. From the relationship with the urethra 1300, the implant body 91 is disposed in parallel with the corrected urethra 1300.

  Next, as shown in FIG. 26A, the thread 341 exposed from the exposure holes 345 and 346 is cut. As a result, the main body 31 can be divided into the tip split piece 32 and the base split piece 33. Since the exposure holes 345 and 346 are located on the proximal end side with respect to the anchor 82, the exposure holes 345 and 346 are surely exposed to the outside of the living body. Therefore, the yarn 341 can be easily cut.

  Next, the adsorption of the urethra 1300 by the urethral insertion part 41 and the adsorption of the vaginal front wall 1410 by the vagina insertion part 51 are stopped. As a result, the positions and shapes of the urethra 1300 and the vagina 1400 return to the original natural state.

  Next, the connection between the distal end split piece 32 and the proximal end split piece 33 is released, the distal end split piece 32 is pulled out from the living body toward the distal end side, and the proximal end split piece 33 is pulled out from the living body toward the proximal end side. At this time, the tip split piece 32 and the base end split piece 33 are moved substantially simultaneously in opposite directions, and the tip split piece 32 and the base end split piece 33 are each moved in an arc shape along the shape thereof. Thereby, the main body 31 is smoothly removed from the living body. When the distal-end divided piece 32 and the proximal-end divided piece 33 are removed from the living body as described above, the surrounding tissue that has been spread by the main body 31 returns to the original position, and both end portions from the central portion of the implant main body 91 are restored. The tissue gradually comes into contact with the implant body 91 toward the end. As described above, the distal end split piece 32 and the proximal end split piece 33 are moved in a direction along the shape thereof, and the main body 31 has an internal space in which the implant main body 91 can be moved with sufficiently low friction. Thus, an unnecessary tensile force is not applied to the implant main body 91, and the implant main body 91 can be placed as it is. Thereby, adjustment of the tension of the implant main body 91 becomes unnecessary. As described above, as shown in FIG. 26B, the implant body 91 is embedded in the living body.

  In a state where the implant main body 91 is embedded in the living body, the main body portion 911 is disposed substantially parallel to the urethra 1300 in a region between the urethra 1300 and the vagina 1400. Therefore, the urethra 1300 can be supported in a wider area by the implant body 91.

  Thus, by removing the main body 31 from the living body by dividing it, the main body 31 can be easily removed from the living body. Further, since the main body 31 can be removed from the living body without removing the anchors 81 and 82 from the main body 31, the main body 31 can be easily removed. Further, according to such an extraction method, the divided pieces 32 and 33 being extracted hardly affect the posture of the main body 911 in the region between the urethra 1300 and the vagina 1400.

  Further, since the split pieces 32 and 33 are removed from the living body in a state where the urethra insertion member 4 is inserted into the urethra 1300, the implant body 91 placed in the living body prevents excessive tension from being applied to the urethra 1300. I can do it.

Next, the urethral insertion member 4 is removed from the urethra 1300, and the vagina insertion member 5 is removed from the vagina 1400. After the urethral insertion member 4 is removed, the urethra 1300 returns to the natural shape, but the main body portion 911 is embedded in the tissue, so that the urethra 1300 in the natural state and the main body portion 911 are maintained in a parallel state. Can do.
Thereafter, unnecessary portions of the implant body 91 are excised, and the procedure is finished.

  As described above, according to the puncture device 1, when the implant body 91 is placed in the living body, it can be handled only by a minimally invasive technique such as puncture of the puncture member 3. Since it does not have to be performed, the burden on the patient is small, and the safety of the patient is high. In addition, the implant body 91 can be easily and reliably placed in the living body.

  Further, the puncture member 3 can puncture the living body while avoiding the urethra 1300 and the vagina 1400, and the puncture member 3 can be prevented from puncturing the urethra 1300 and the vagina 1400, which is safe.

  Moreover, even if the blood vessel, bladder, urethra, etc. are accidentally punctured by the puncture member 3, the erroneous puncture can be confirmed by flashback of blood or the like, and the procedure can be performed more safely. it can.

  Moreover, it prevents the occurrence of complications such as the implant body 91 being exposed in the vagina from the wound created by the incision and the infection from the wound as in the case of the conventional incision of the vagina. It is possible to embed the implant body 91 with certainty.

Second Embodiment
FIG. 27 is a perspective view showing a medical tube assembly according to a second embodiment of the present invention. FIG. 28 is a cross-sectional view showing a modification of the medical tube assembly shown in FIG.

  Hereinafter, the second embodiment of the medical tube assembly will be described with reference to this figure, but the description will focus on the differences from the first embodiment described above, and the description of the same matters will be omitted.

  This embodiment is mainly the same as the first embodiment described above except that the configuration of the puncture member is different.

  As shown in FIG. 27, the puncture member 3 </ b> A of the medical tube assembly 10 of the present embodiment includes a sheath 30 and a distal end portion 711 that is a distal end portion of the insertion portion 71. That is, the puncture member 3 </ b> A has a configuration in which the needle body 35 is changed to the distal end portion 711 which is the distal end portion of the insertion portion 71 in the puncture member 3 of the first embodiment described above. Further, in a state (initial state) in which the insertion portion 71 is inserted into the puncture member 3, the distal end portion 711 that is the distal end portion of the insertion portion 71 protrudes from the distal end side opening of the main body 31. The tip 711 protruding from the main body 31 also serves as the needle tip (needle body) of the puncture member 3A. Thus, when the distal end portion 711 of the insertion portion 71 also serves as the needle body of the puncture member 3A, for example, the number of members can be reduced as compared with the first embodiment described above. Moreover, if the puncture member 3 is punctured into a living body and the insertion portion 71 is removed from the puncture member 3, the distal end side opening of the main body 31 can be opened. In other words, according to the present embodiment, unlike the first embodiment described above, it is not necessary to remove the needle body 35 in order to open the distal end side opening of the main body 31, so that surgery can be performed more smoothly. . Further, since the outer diameter of the insertion portion 71 and the inner diameter of the opening on the distal end side of the main body 31 are set to be substantially the same, the displacement of the insertion portion 71 with respect to the main body 31 is prevented, and the operability is improved.

  In addition, a tapered portion 319 in which the outer diameter from the distal end side opening gradually increases toward the proximal end is provided at the distal end of the main body 31. The tapered portion 319 functions as a peeling portion that peels off the living body gradually so as to gradually expand following the distal end portion 711 as the distal end portion 711 of the insertion portion 71 punctures the living body.

  The taper angle of the taper portion 319 and the taper angle of the tip portion 711 may be the same, but are preferably different as shown in FIG. In this case, it is preferable that the taper angle of the taper portion 319 is smaller than the taper angle of the tip portion 711. Thereby, smooth puncture can be performed.

  Also according to the second embodiment, the same effects as those of the first embodiment described above can be obtained.

  Moreover, the following structures are mentioned as a modification of this embodiment. As shown in FIG. 28, the puncture member 3 </ b> A includes a sheath 30 and a distal end portion 711 that is a distal end portion of the insertion portion 71. That is, the puncture member 3 </ b> A has a configuration in which the needle body 35 is changed to the distal end portion 711 of the insertion portion 71 in the puncture member 3 of the first embodiment described above. Further, in a state (initial state) in which the insertion portion 71 is inserted into the puncture member 3, the distal end portion 711 that is the distal end portion of the insertion portion 71 protrudes from the distal end side opening of the main body 31.

  The distal end portion 711 is detachable from the insertion portion 71 by screwing, fitting, or the like. Further, the distal end portion 711 has a needle tip 712 protruding from the distal end of the sheath 30. The needle tip 712 has a flat shape following the sheath 30. Further, the needle tip 712 has an area gradually increasing portion 712a in which the cross-sectional area gradually increases toward the tip, and an area gradually decreasing portion 712b that is provided on the tip side of the area gradually increasing portion 712a and in which the cross-sectional area gradually decreases toward the tip. ing. The short axis of the boundary portion 712c between the area gradually increasing portion 712a and the area gradually decreasing portion 712b is longer than the short axis of the distal end of the sheath 30, and the long axis of the boundary portion 712c is longer than the long axis of the distal end of the sheath 30. Thereby, the living body can be punctured substantially only with the needle tip 712. Therefore, puncture resistance can be reduced and puncture into a living body can be performed more smoothly. Note that the short axis of the boundary portion 712c may be equal to the short axis of the distal end of the sheath 30, and the long axis of the boundary portion 712c may be equal to the long axis of the sheath 30 distal end.

  The second embodiment and its modifications can also be applied to each embodiment described later.

<Third Embodiment>
FIG. 29 is a plan view showing a medical tube assembly according to a third embodiment of the present invention. In FIG. 29, for the sake of convenience of explanation, the puncture member extending in an arc shape is linearly extended and the needle body, the state maintaining mechanism, the distal end portion of the insertion portion, etc. are not shown. Yes.

  Hereinafter, the third embodiment of the medical tube assembly will be described with reference to this figure, but the description will focus on the differences from the first embodiment described above, and the description of the same matters will be omitted.

  As shown in FIG. 29, in the medical tube assembly 10 of the present embodiment, the main body 31 of the sheath 30 has a single tube shape. In this case, the state maintaining mechanism 34 is omitted. The through hole 311 is arranged in a spiral shape.

  In the medical tube assembly 10, when the implant body 91 is placed in the living body, when the sheath 30 is removed, the sheath 30 is pulled out from the living body toward the distal end side or the proximal end side.

  According to the third embodiment, the same effect as that of the first embodiment described above can be obtained.

<Fourth embodiment>
FIG. 30 is a plan view showing a medical tube assembly according to a fourth embodiment of the present invention. In FIG. 30, for the sake of convenience of explanation, the puncture member extending in an arc shape is shown linearly extended, and the illustration of the needle body, the state maintaining mechanism, the distal end portion of the insertion portion, etc. is omitted. Yes.

  Hereinafter, the fourth embodiment of the medical tube assembly will be described with reference to this figure. However, the difference from the above-described third embodiment will be mainly described, and the description of the same matters will be omitted.

  As shown in FIG. 30, in the medical tube assembly 10 of the present embodiment, the main body 31 of the sheath 30 includes an outer tube 371 and an inner tube 372 disposed on the inner peripheral side of the outer tube 371. Yes. A space between the outer tube 371 and the inner tube 372 and a plurality of through-holes 311 described later function as a flow path through which a liquid flows while the puncture member 3 (medical tube assembly 10) is pierced through a living body. .

  A plurality of through holes 311 communicating with the space between the outer tube 371 and the inner tube 372 are formed on the side surface of the outer tube 371. That is, each through hole 311 connects the outer peripheral surface and the inner peripheral surface of the outer tube. Further, the through hole 311 is formed over the entire region of the main body 31, that is, over the entire length. Thereby, it is possible to detect an erroneous puncture of a blood vessel over a wide range.

  The lumen of the inner tube 372 is the lumen of the main body 31, and when the implant main body 91 is placed in the living body, the implant main body 91 is disposed in the lumen.

  In this medical tube assembly 10, for example, when a living body is punctured with the puncture member 3, if a blood vessel is erroneously punctured, blood that has flowed out from the wound of the blood vessel passes through the through-hole 311 and the outer tube 371 and the inner tube. It flows into the space between 372 and flows through that space. Thereby, it is possible to prevent the lumen of the inner tube 372 in which the implant main body 91 is disposed from being stained with blood or the like.

  According to the fourth embodiment, the same effect as that of the third embodiment described above can be obtained.

<Fifth Embodiment>
FIG. 31 is a plan view showing a medical tube assembly according to a fifth embodiment of the present invention. In FIG. 31, for the convenience of explanation, the puncture member extending in an arc shape is illustrated as being linearly extended, and the illustration of the needle body, the state maintaining mechanism, the distal end portion of the insertion portion, and the like is omitted. Yes.

  Hereinafter, the fifth embodiment of the medical tube assembly will be described with reference to this figure. However, the difference from the first embodiment will be mainly described, and the description of the same matters will be omitted.

  As shown in FIG. 31, in the medical tube assembly 10 of the present embodiment, the main body 31 of the sheath 30 is viewed from the axial direction, and a distal end split piece (first split tube) 32 disposed on the distal end side. And a base end split piece (second split tube) 33 disposed on the base end side, and is disposed on the inner peripheral side of the outer tube 371 and the outer tube 371 in the radial direction. The inner tube 372 is formed. The space between the outer tube 371 and the inner tube 372 functions as a flow path through which the liquid flows in a state where the puncture member 3 (medical tube assembly 10) has penetrated the living body. A plurality of through holes 311 communicating with the space between the outer tube 371 and the inner tube 372 are formed on the side surface of the outer tube 371.

  The lumen of the inner tube 372 is the lumen of the main body 31, and when the implant main body 91 is placed in the living body, the implant main body 91 is disposed in the lumen.

  In this medical tube assembly 10, for example, when a living body is punctured with the puncture member 3, if a blood vessel is erroneously punctured, blood that has flowed out from the wound of the blood vessel passes through the through-hole 311 and the outer tube 371 and the inner tube. It flows into the space between 372 and flows through that space. Thereby, it is possible to prevent the lumen of the inner tube 372 in which the implant main body 91 is disposed from being stained with blood or the like.

  According to the fifth embodiment, the same effect as that of the first embodiment described above can be obtained.

<Sixth Embodiment>
FIG. 32 is a plan view showing a medical tube assembly according to a sixth embodiment of the present invention. In FIG. 32, for convenience of explanation, the puncture member extending in an arc shape is illustrated as being linearly extended, and the illustration of the needle body, the state maintaining mechanism, the distal end portion of the insertion portion, and the like is omitted. Yes.

  Hereinafter, the sixth embodiment of the medical tube assembly will be described with reference to this figure. However, the difference from the fourth embodiment described above will be mainly described, and the description of the same matters will be omitted.

  As shown in FIG. 32, in the medical tube assembly 10 of the present embodiment, four grooves 312 extending in the axial direction of the main body 31 are formed on the outer peripheral surface of the inner tube 372 of the main body 31 of the sheath 30. . Each groove 312 has a linear shape, is formed from the distal end to the proximal end of the main body 31, and is open to the distal end and the proximal end, respectively. Each groove 312 is disposed along the circumferential direction of the inner tube 372. Note that the shape and arrangement of the grooves 312 are not limited to the illustrated configuration, and other shapes include, for example, a spiral shape. The number of grooves 312 is not limited to four, and may be one, two, three, or five or more.

  A plurality of through holes 311 that communicate with the respective grooves 312 are formed on the side surface of the outer tube 372. In the present embodiment, a plurality of through holes 311 are formed for each groove 312. Each through hole 311 is formed in the central portion of the main body 31.

  In this medical tube assembly 10, each groove 312 and the through hole 311 function as a flow path through which a liquid flows while the puncture member 3 (medical tube assembly 10) is pierced through a living body. Thus, since the flow path is constituted by the groove 312, the flow path is reliably ensured, and a liquid such as blood can flow smoothly and reliably.

  Also according to the sixth embodiment, the same effects as those of the fourth embodiment described above can be obtained.

<Seventh embodiment>
FIG. 33 is a plan view showing a medical tube assembly according to a seventh embodiment of the present invention. In FIG. 33, for convenience of explanation, the puncture member extending in an arc shape is illustrated as being linearly extended, and the illustration of the needle body, the state maintaining mechanism, the distal end portion of the insertion portion, and the like is omitted. Yes.

  Hereinafter, the seventh embodiment of the medical tube assembly will be described with reference to this figure, but the description will focus on the differences from the third embodiment described above, and the description of the same matters will be omitted.

  As shown in FIG. 33, in the medical tube assembly 10 of the present embodiment, four grooves (concave portions) 313 extending in the axial direction of the main body 31 are formed on the outer peripheral surface of the main body 31 of the sheath 30. Each groove 313 has a straight line shape and is formed from the distal end to the proximal end of the main body 31, and is open to the distal end and the proximal end, respectively. Each groove 313 is disposed along the circumferential direction of the main body 31. Each of these grooves 313 functions as a flow path through which a liquid flows while the puncture member 3 (medical tube assembly 10) is pierced through a living body. Note that the shape and arrangement of the grooves 313 are not limited to the illustrated configuration, and other shapes include, for example, a spiral shape. The number of grooves 313 is not limited to four, and may be one, two, three, or five or more.

  Also according to the seventh embodiment, the same effects as those of the third embodiment described above can be obtained.

<Eighth Embodiment>
FIG. 34 is a plan view showing a medical tube assembly according to an eighth embodiment of the present invention. In FIG. 34, for convenience of explanation, the puncture member extending in an arc shape is illustrated as being linearly extended, and the illustration of the needle body, the state maintaining mechanism, the distal end portion of the insertion portion, and the like is omitted. Yes.

  Hereinafter, the eighth embodiment of the medical tube assembly will be described with reference to this figure, but the description will focus on differences from the third embodiment described above, and the description of the same matters will be omitted.

  As shown in FIG. 34, in the medical tube assembly 10 of the present embodiment, four grooves (concave portions) 313 extending in the axial direction of the main body 31 are formed on the outer peripheral surface of the main body 31 of the sheath 30. Each groove 313 has a straight line shape and is formed from the distal end to the proximal end of the main body 31, and is open to the distal end and the proximal end, respectively. Each groove 313 is disposed along the circumferential direction of the main body 31. The groove 313 may be formed not only over the entire length of the main body 31 but only in the central portion of the main body 31, for example. In addition, the shape and arrangement of the grooves 313 are not limited to the illustrated configuration, and other shapes include, for example, a spiral shape. The number of grooves 313 is not limited to four, and may be one, two, three, or five or more.

  In addition, a plurality of through holes 311 are formed at the bottom of each groove 313. That is, the end of each through hole 311 is disposed in the groove 313. When the puncture member 3 punctures the living body, the groove 313 can prevent the through-hole 311 from being covered with the biological tissue. Blood can be reliably guided to the through hole 311.

  In this embodiment, the lumen of the main body 31 functions as a flow path through which the liquid flows while the puncture member 3 (medical tube assembly 10) is pierced through the living body. , Having the function of the flow path.

  Also according to the eighth embodiment, the same effects as those of the third embodiment described above can be obtained.

<Ninth Embodiment>
FIG. 35 is a plan view showing a medical tube assembly according to a ninth embodiment of the present invention. In FIG. 35, for convenience of explanation, the puncture member extending in an arc shape is shown linearly extended, and the illustration of the needle body, the state maintaining mechanism, the distal end portion of the insertion portion, etc. is omitted. Yes.

  Hereinafter, the ninth embodiment of the medical tube assembly will be described with reference to this drawing. However, the difference from the above-described eighth embodiment will be mainly described, and the description of the same matters will be omitted.

  As shown in FIG. 35, in the medical tube assembly 10 of the present embodiment, a plurality of recesses 310 are provided on the outer peripheral surface of the main body 31 of the sheath 30 instead of the four straight grooves 313 of the eighth embodiment. Is formed. The recess 310 is formed at the center of the main body 31. And the through-hole 311 is formed in the bottom part in each recessed part 310, respectively. A plurality of through holes 311 may be formed in one recess 310. Moreover, the recessed part 310 may be formed over the whole area | region of the main body 31, ie, the full length.

  Further, the arrangement of the recesses 310 is not particularly limited, and is appropriately set according to various conditions. In the present embodiment, the arrangement is regularly, and specifically, the axial direction of the main body 31. Are arranged at equal intervals in the circumferential direction. In addition, as another arrangement | positioning of the recessed part 310, the case where it arrange | positions irregularly etc. are mentioned, for example, when arrange | positioning helically.

  According to the ninth embodiment, the same effect as that of the eighth embodiment described above can be obtained.

<Tenth Embodiment>
FIG. 36 is a plan view showing a medical tube assembly according to a ninth embodiment of the present invention. In FIG. 36, for the sake of convenience of explanation, the puncture member extending in an arc shape is linearly extended and the needle body, the state maintaining mechanism, the distal end portion of the insertion portion, etc. are not shown. Yes.

  Hereinafter, the tenth embodiment of the medical tube assembly will be described with reference to this figure, but the description will focus on the differences from the eighth embodiment described above, and the description of the same matters will be omitted.

  As shown in FIG. 36, in the medical tube assembly 10 of the present embodiment, a spiral groove 314 is provided on the outer peripheral surface of the main body 31 of the sheath 30 instead of the four straight grooves 313 of the eighth embodiment. Is formed. Further, the groove 314 is formed in the central portion of the main body 31.

  The groove 314 may be formed over the entire region of the main body 31, that is, over the entire length. In this case, the through hole 313 may be formed over the entire length of the groove 314.

  The tenth embodiment can provide the same effects as those of the eighth embodiment described above.

<Eleventh embodiment>
FIG. 37 is a side view showing a medical tube assembly according to an eleventh embodiment of the present invention. FIG. 38 is a side view showing a distal end portion of the medical tube assembly shown in FIG. 39 is a cross-sectional view taken along line BB in FIG. 40 to 44 are views for explaining an example of use of the medical tube assembly shown in FIG. 37 to 44, the state maintaining mechanism and the like are not shown for convenience of explanation.

  Hereinafter, the eleventh embodiment of the medical tube assembly will be described with reference to this figure. However, the difference from the second embodiment will be mainly described, and the description of the same matters will be omitted.

  This embodiment is mainly the same as the second embodiment described above except that the configuration of the sheath 30 is different.

  As shown in FIGS. 37 to 39, the medical tube assembly 10 of the present embodiment is a connecting portion that releasably connects the distal end portion of the main body 31 of the sheath 30 and the distal end portion 711 of the insertion portion 71. With the flexible bag body (recessed portion) 121 and the distal end portion of the main body 31 and the distal end portion 711 of the insertion portion 71 connected to each other, an axis between the distal end portion of the main body 31 and the distal end portion 711 of the insertion portion 71 And a rotation restricting portion (first rotation restricting portion) 13 for restricting the rotation of the rotation.

  The bag body 121 is provided at the tip of the main body 31. The bag body 121 has a bottom with an opening 122 at one end and a closed end. The bag body 121 may have no bottom. When the bag body 121 does not have a bottom, the distal end portion 711 of the insertion portion 71 can be exposed to the outside, and the living body can be directly punctured by the distal end portion 711 of the insertion portion 71, so puncture resistance is low. Easy to puncture.

  Further, the shape of the bag body 121 corresponds to the shape of the distal end portion 711 of the insertion portion 71. In the illustrated configuration, the shape of the insertion section 71 in the cross section is a flat shape, and the shape of the bag body 121 in the cross section is correspondingly flat.

  The distal end portion 711 of the insertion portion 71 is inserted into the bag body 121 through the opening 122. Thereby, the front-end | tip part of the main body 31 and the front-end | tip part 711 of the insertion part 71 are connected. Thereby, when the puncture member 3 punctures a living body, the main body 31 moves together with the insertion portion 71. Note that the insertion portion 71 is not inserted into the lumen of the main body 31. Hereinafter, a state in which the distal end portion of the main body 31 and the distal end portion 711 of the insertion portion 71 are connected is also referred to as a “connected state”.

  Moreover, since the shape in the cross section of the front-end | tip part 711 and the bag body 121 has comprised flat shape, in the connection state, the front-end | tip part 711 and the bag body 121 are the axis | shafts of the front-end | tip part of the main body 31, and the front-end | tip part 711. Engaging in the rotation direction around, the rotation around the axis between the distal end portion of the main body 31 and the distal end portion 711 of the insertion portion 71 is restricted. Thereby, when the puncture member 3 punctures a living body, the main body 31 moves side by side with the insertion portion 71. Thereby, the main body 31 can be reliably arranged at the same position as the movement locus of the distal end portion 711 of the insertion portion 71.

  The bag body 121 constitutes a first engagement portion, and the distal end portion 711 of the insertion portion 71 constitutes a second engagement portion that engages with the first engagement portion. Further, the rotation restricting portion 13 is configured by the bag body 121 and the distal end portion 711 of the insertion portion 71. Thus, in the present embodiment, the rotation restricting portion 13 is provided at the distal end portions of the main body 31 and the insertion portion 71.

  When the cross-sectional shape of the main body 31 is a flat shape, the rotation restricting portion 13 is inserted into the main body 31 so that the long axis J32 in the cross-section of the main body 31 and the axis of the urethral insertion member 4 are parallel to each other. The rotation around the axis with the portion 71 is restricted.

  Moreover, it does not specifically limit as a constituent material of the bag body 121, For example, a resin material, paper, a metal material, etc. are mentioned.

  The axial length of the main body 31 is longer than the axial length of the insertion portion 71. This is because the insertion portion 71 is not inserted into the lumen of the main body 31. Thereby, it can respond also to a fat patient, for example. That is, by appropriately setting the length of the main body 31 in the axial direction, the implant main body 91 can be easily and reliably placed in a living body for patients of various body types. Needless to say, the axial length of the main body 31 may be the same as the axial length of the insertion portion 71 or may be shorter than the axial length of the insertion portion 71.

  Moreover, it is preferable that the main body 31 is rigid so that the curvature and lumen of the main body 31 can be maintained in a state where the main body 31 is inserted into the living body (a state where the living body is pierced).

  Moreover, it is preferable that at least a part of the main body 31 has flexibility. In the configuration shown in the drawing, a portion in the vicinity of the central portion S4 of the main body 31 has flexibility. This makes it easier for the main body 31 to follow the insertion portion 71 when the puncture member 3 punctures a living body.

  In addition, a marker 141 is provided at the tip of the main body 31. The marker 141 is arranged such that the distance from the central portion S4 of the main body 31 to the marker 141 is equal to the distance from the central portion S4 to the base end. With this marker 141, as will be described later, the central portion S4 of the main body 31 can be reliably disposed between the urethra and the vagina.

  Next, the main steps of the operation procedure of the puncture apparatus 1 will be described focusing on differences from the first and second embodiments.

  First, the operating member 7 is operated (see FIG. 20), and the medical tube assembly 10 in the state shown in FIG. 37 is punctured into the patient (see FIGS. 40 and 41). At this time, with the distal end portion of the main body 31 and the distal end portion 711 of the insertion portion 71 coupled, the insertion portion 71 and the main body 31 are inserted into the living body side by side.

  Next, as shown in FIG. 42, the front end portion of the main body 31 or the bag body 121 is grasped and pulled, and the main body 31 is further moved in the front end direction. Thereby, the insertion portion 71 is detached from the bag body 121.

Next, as shown in FIG. 43, the operation member 7 is operated to remove the insertion portion 71 from the living body.
Next, the position of the main body 31 is adjusted so that the height of the marker 141 is equal to the height of the base end of the main body 31. Thereby, the center part S4 of the main body 31 is disposed between the urethra and the vagina.

  Next, as shown in FIG. 43, the tip of the main body 31 is cut at, for example, a marker 141. Thus, the main body 31 is disposed in the living body. The main body 31 can be removed from the proximal end portion so that the main body 31 is divided into a distal end portion and a proximal end portion from the marker 141 at the position of the marker 141. It may be.

  As described above, according to the puncture device 1, the length of the main body 31 of the sheath 30 can be made longer than the length of the insertion portion 71. Therefore, by appropriately setting the length of the main body 31, for example, The implant body 91 can be easily and reliably placed in a living body for patients of various body types such as a fat patient.

  Further, when the implant main body 91 is placed in the living body, it can be dealt with only by a minimally invasive technique such as puncture of the puncture member 3, and it is not necessary to make a large invasive incision or the like. Also, patient safety is high.

  Further, the puncture member 3 can puncture the living body while avoiding the urethra 1300 and the vagina 1400, and the puncture member 3 can be prevented from puncturing the urethra 1300 and the vagina 1400, which is safe.

  Moreover, it prevents the occurrence of complications such as the implant body 91 being exposed in the vagina from the wound created by the incision and the infection from the wound as in the case of the conventional incision of the vagina. It is possible to embed the implant body 91 with certainty.

  In the present embodiment, the insertion portion 71 is configured to press and move the sheath 30. However, the present invention is not limited to this. For example, the insertion portion 71 is configured to pull and move the sheath 30. May be.

<Twelfth embodiment>
FIG. 45 is a side view showing the distal end portion of the medical tube assembly according to the twelfth embodiment of the present invention. 46 is a cross-sectional view taken along the line CC in FIG. In FIG. 45, the state maintaining mechanism and the like are not shown for convenience of explanation.

  Hereinafter, the twelfth embodiment of the medical tube assembly will be described with reference to this figure, but the description will focus on the differences from the eleventh embodiment described above, and the description of the same matters will be omitted.

  As shown in FIGS. 45 and 46, in the medical tube assembly 10 of the present embodiment, the puncture member 3 includes a sheath 30 and a needle body 35 provided at the distal end of the sheath 30 as in the first embodiment. And have. Since this configuration has been described in the first embodiment, a description thereof will be omitted.

  The needle body 35 is formed with a recess 123 as a connecting portion. The shape of the concave portion 123 corresponds to the shape of the distal end portion 711 of the insertion portion 71. In the configuration shown in the drawing, the shape of the distal end portion 711 of the insertion portion 71 in the cross section is a quadrangle, and the shape of the recess 123 in the cross section is correspondingly square.

  The distal end 711 of the insertion portion 71 is inserted into the recess 123. Accordingly, the distal end portion of the main body 31 and the distal end portion 711 of the insertion portion 71 are indirectly connected via the needle body 35. Further, in the connected state, the distal end portion 711 and the recessed portion 123 engage in the rotational direction around the axis of the distal end portion and the distal end portion 711 of the main body 31, and the distal end portion of the main body 31 and the distal end portion 711 of the insertion portion 71 are engaged. The rotation around the axis is restricted.

  The concave portion 123 constitutes a first engaging portion, and the distal end portion 711 of the insertion portion 71 constitutes a second engaging portion that engages with the first engaging portion. Further, the rotation restricting portion 13 is configured by the concave portion 123 and the distal end portion 711 of the insertion portion 71.

  Also according to the twelfth embodiment, the same effects as those of the eleventh embodiment described above can be obtained.

<13th Embodiment>
FIG. 47 is a cross-sectional view showing a portion in the middle of the medical tube assembly according to the thirteenth embodiment of the present invention.

  Hereinafter, the thirteenth embodiment of the medical tube assembly will be described with reference to this figure, but the description will focus on the differences from the eleventh and twelfth embodiments described above, and the description of the same matters will be omitted. To do.

  As shown in FIG. 47, in the medical tube assembly 10 of the present embodiment, the outer peripheral surface of the sheath 30 in the middle of the main body 31 in the axial direction is curved toward the inner side (center side). A groove (concave portion) 151 is formed. Moreover, the shape in the cross section of the site | part of the base end side rather than the front-end | tip part 711 of the insertion part 71 is circular, The insertion part 71 can be engaged with the groove | channel 151. FIG.

  Thereby, when the puncture member 3 punctures a living body, the insertion portion 71 and the groove 151 are engaged, and rotation of the insertion portion 71 and the main body 31 around the axis is restricted. The groove 151 and the portion of the insertion portion 71 that engages with the groove 151 constitute a second rotation restricting portion that restricts the rotation of the insertion portion 71 and the body 31 about the axis. As described above, in the present embodiment, the second rotation restricting portion is provided on the side surfaces of the main body 31 and the insertion portion 71. In addition, the 2nd rotation control part may be provided over the full length of the site | part of the base end side rather than the front-end | tip part of the medical tube assembly 10, and may be provided in a part.

  Also according to the thirteenth embodiment, the same effects as those of the eleventh and twelfth embodiments described above can be obtained.

<Fourteenth embodiment>
FIG. 48 is a cross-sectional view showing a portion in the middle of the medical tube assembly according to the fourteenth embodiment of the present invention.

  Hereinafter, the fourteenth embodiment of the medical tube assembly will be described with reference to this figure, but the description will focus on the differences from the eleventh and twelfth embodiments described above, and the description of the same matters will be omitted. To do.

  As shown in FIG. 48, in the medical tube assembly 10 of the present embodiment, a groove (concave portion) 152 is formed on the outer peripheral surface of a portion of the sheath 31 in the axial direction of the main body 31. Moreover, the shape in the cross section of the site | part of the base end side rather than the front-end | tip part 711 of the insertion part 71 has comprised the circle. In addition, a rib (convex portion) 713 that can engage with the groove 152 is formed on the outer peripheral surface of a portion in the axial direction of the insertion portion 71.

  Thereby, when the puncture member 3 punctures a living body, the rib 713 and the groove 151 of the insertion portion 71 are engaged, and the rotation about the axis between the insertion portion 71 and the main body 31 is restricted. The groove 151 and the rib 713 constitute a second rotation restricting portion that restricts the rotation of the insertion portion 71 and the main body 31 around the axis. As described above, in the present embodiment, the second rotation restricting portion is provided on the side surfaces of the main body 31 and the insertion portion 71. In addition, the 2nd rotation control part may be provided over the full length of the site | part of the base end side rather than the front-end | tip part of the medical tube assembly 10, and may be provided in a part.

  The fourteenth embodiment can provide the same effects as those of the eleventh and twelfth embodiments described above.

<Fifteenth embodiment>
FIG. 49 is a sectional view showing a medical tube (medical tube assembly) according to a fifteenth embodiment of the present invention. 50 to 52 are diagrams for explaining an example of use of the medical tube (medical tube assembly) shown in FIG. 49. 49 to 52, the state maintaining mechanism and the like are not shown for convenience of explanation.

  Hereinafter, the fifteenth embodiment of the medical tube assembly will be described with reference to this drawing. The fifteenth embodiment will be described mainly with respect to differences from the first embodiment described above, and the description of the same matters will be omitted.

  As shown in FIGS. 49 and 51, the sheath 30 of the present embodiment is provided at the main body 31, the needle body 35, the state maintaining mechanism 34, and the distal end portion of the main body 31, with respect to the central portion of the main body 31. And an enlarged diameter portion 16 having an enlarged diameter. The enlarged diameter portion 16 can be enlarged or reduced in diameter. The enlarged diameter portion 16 may be provided at the proximal end portion of the main body 31, or may be provided at each of the distal end portion and the proximal end portion of the main body 31. Further, the enlarged diameter portion 16 may be a separate body from the main body 31 or may be formed integrally. Hereinafter, the enlarged diameter portion 16 will be described.

  The enlarged diameter portion 16 includes a bone member 161 and a sheet 164 that is supported by the bone member 161 and has flexibility. The bone member 161 includes a plurality of bone portions 162 that are linear and elastically deformable, and an annular support portion 163 that supports the base end portion of each bone portion 162. The support part 163 is installed at the tip of the main body 31 so as to be movable in the axial direction of the main body 31, and the bone parts 162 are arranged at equal intervals along the circumferential direction of the support part 163. In addition, each bone part 162 and the support part 163 may be integrally formed, and may be separate. Further, the back side of the sheet 164 is fixed to each bone portion 162.

  First, based on FIG. 51, the state where the diameter-expanded portion 16 has been expanded will be described. Each bone portion 162 is a natural state where no external force is applied, and when viewed from the axial direction of the main body 31 (support portion 163), the distal end portion is positioned outside the proximal end portion, and the entire bone portion 162 As seen from the above, the tip end portion spreads outside the base end portion. Further, each bone portion 162 is located on the distal end side of the distal end portion of the main body 31, that is, outside the main body 31. In addition, the base end part of each bone part 162 may be located in the main body 31. And in this state, the sheet | seat 164 is being fixed to each bone part 162 so that the front-end | tip part may make the cylinder shape expanded diameter rather than the base end part. The inner diameter of the enlarged diameter portion 16 gradually increases in the direction away from the main body 31 along the axial direction of the main body 31.

  In addition, the constituent material of each bone part 162 is not particularly limited as long as it can be elastically deformed. For example, a superelastic alloy such as a Ni-Ti alloy is preferable.

  Further, the constituent material of the sheet 164 is not particularly limited as long as it has flexibility, and examples thereof include a soft resin material and paper.

  As shown in FIGS. 49 and 50, such an enlarged diameter portion 16 has a reduced diameter in the inner cavity of the distal end portion of the main body 31, that is, in a state where each bone portion 162 is elastically deformed, It is accommodated so as to be movable along the axial direction.

  Each bone portion 162 functions as an urging portion that urges the diameter-expanded portion 16 in the diameter-expanding direction. Moreover, the front-end | tip part of the main body 31 functions as a holding | maintenance part which hold | maintains the diameter-expanded part 16 in the state reduced in diameter against the urging | biasing force of the said urging | biasing part.

  The needle body 35 is detachably attached to the distal end portion of the main body 31. Further, the needle body 35 and the distal end portion of the enlarged diameter portion 16 are connected by a thread 142. The distal end portion of the thread 142 is fixed or supported on the proximal end portion of the needle body 35, and the proximal end portion is fixed or supported on the distal end portion of the enlarged diameter portion 16.

  When the needle body 35 is detached from the distal end portion of the main body 31, after the needle body 35 is detached from the distal end portion of the main body 31, when the needle body 35 is further pulled in the distal direction, the needle body 35 is interposed via the thread 142. Thus, the distal end portion of the enlarged diameter portion 16 is pulled in the distal direction, and the enlarged diameter portion 16 protrudes from the inside of the main body 31 to the outside. Thereby, each bone part 162 is restored to a natural state by its elastic force, and the diameter-expanded part 16 is expanded. As described above, the needle body 35 also serves as an operation portion that performs an operation of expanding the diameter-expanded portion 16, and in conjunction with the detachment operation that separates the needle body 35 from the distal end portion of the main body 31, the diameter-expanded portion 16. Expands in diameter. In addition, the full length of the main body 31 is extended because the diameter expansion part 16 protrudes from the front-end | tip part of the main body 31, and is diameter-expanded.

  Next, main steps of the operation procedure of the puncture apparatus 1 will be described focusing on differences from the first embodiment.

  First, as shown in FIG. 49, the operation member 7 is operated (see FIG. 20) to puncture the patient with the medical tube assembly 10.

  Next, as shown in FIG. 50, the operation member 7 is operated to remove the insertion portion 71 from the living body. Thus, the main body 31 is disposed in the living body.

  Next, as shown in FIG. 51, the needle body 35 is detached from the distal end portion of the main body 31, and the needle body 35 is pulled in the distal end direction. As a result, the tip of the enlarged diameter portion 16 is pulled in the distal direction by the needle body 35 via the thread 142, and the enlarged diameter portion 16 protrudes from the inside of the main body 31 to the outside. As a result, each bone portion 162 is restored to its natural state by its elastic force, and the diameter-expanded portion 16 is expanded.

  Next, as shown in FIG. 52, the implant main body 91 is inserted into the main body 31 from the diameter change shape 16. At this time, since the diameter-changing shape 16 is enlarged, the implant body 91 can be easily and smoothly inserted into the body 31.

  As described above, according to the puncture device 1, since the diameter-enlarged portion 16 is provided, the implant body 91 can be easily and reliably inserted into the body 31 even if the diameter of the body 31 is reduced. Thus, the implant main body 91 can be placed in the living body easily and reliably.

  Further, by reducing the diameter of the main body 31, the burden on the patient can be reduced.

  Further, when the implant main body 91 is placed in the living body, it can be dealt with only by a minimally invasive technique such as puncture of the puncture member 3, and it is not necessary to make a large invasive incision or the like. Also, patient safety is high.

  Further, the puncture member 3 can puncture the living body while avoiding the urethra 1300 and the vagina 1400, and the puncture member 3 can be prevented from puncturing the urethra 1300 and the vagina 1400, which is safe.

  Moreover, it prevents the occurrence of complications such as the implant body 91 being exposed in the vagina from the wound created by the incision and the infection from the wound as in the case of the conventional incision of the vagina. It is possible to embed the implant body 91 with certainty.

<Sixteenth Embodiment>
53A and 53B are views showing a medical tube (medical tube assembly) according to a sixteenth embodiment of the present invention, in which FIG. 53A is a cross-sectional view, and FIG. 53B is a DD in FIG. It is line sectional drawing. 54 is a view for explaining an example of use of the medical tube (medical tube assembly) shown in FIG. 53, (a) is a cross-sectional view, and (b) is an E- in (a). It is E line sectional drawing. 53 and 54, the state maintaining mechanism and the like are not shown for convenience of explanation.

  Hereinafter, the sixteenth embodiment of the medical tube assembly will be described with reference to this drawing. However, the difference from the fifteenth embodiment will be mainly described, and the description of the same matters will be omitted.

  As shown in FIGS. 53 and 54, in the sheath 30 of the present embodiment, the diameter-expanded portion 16 has a sheet 165 that is flexible and elastically deformable.

  First, based on FIG. 54, a state where the diameter-expanded portion 16 has been expanded will be described. The sheet 165 is in a natural state where no external force is applied, and has a cylindrical shape in which the distal end is larger in diameter than the proximal end. Further, the sheet 165 can be expanded in diameter by its own restoring force (elastic force) from the reduced diameter state.

  The constituent material of the sheet 165 is not particularly limited as long as it is flexible and elastically deformable, and examples thereof include a soft resin material and paper.

  As shown in FIG. 53, such a sheet 165, that is, the diameter-enlarged portion 16, is reduced in diameter in the inner cavity of the distal end portion of the main body 31, that is, in a state of being rounded into a cylindrical shape. It is stored so that it can move along the direction.

  The sheet 165 functions as an urging portion that urges the sheet 165 itself, that is, the diameter-expanded portion 16 that has been reduced in diameter, in the direction of expanding the diameter.

  When the needle body 35 is detached from the distal end portion of the main body 31, after the needle body 35 is detached from the distal end portion of the main body 31, when the needle body 35 is further pulled in the distal direction, the needle body 35 is interposed via the thread 142. Thus, the distal end portion of the enlarged diameter portion 16 is pulled in the distal direction, and the enlarged diameter portion 16 protrudes from the inside of the main body 31 to the outside. Thereby, the sheet 165 is restored to a natural state by the restoring force, and the sheet 165, that is, the diameter-expanded portion 16 is expanded.

  The sixteenth embodiment can provide the same effects as those of the fifteenth embodiment described above.

<Seventeenth Embodiment>
FIG. 55 is a cross-sectional view showing a medical tube (medical tube assembly) according to a seventeenth embodiment of the present invention. FIG. 56 is a view for explaining an example of use of the medical tube (medical tube assembly) shown in FIG. FIG. 57 is a view for explaining an example of use of the medical tube (medical tube assembly) shown in FIG. 55, (a) is a cross-sectional view, and (b) is F- in (a). It is F line sectional drawing. 58 is a view for explaining an example of use of the medical tube (medical tube assembly) shown in FIG. 55, (a) is a cross-sectional view, and (b) is a cross-sectional view of G- in FIG. FIG. In FIGS. 55 to 58, the state maintaining mechanism and the like are not shown for convenience of explanation.

  Hereinafter, the seventeenth embodiment of the medical tube assembly will be described with reference to this drawing. However, the difference from the fifteenth embodiment will be mainly described, and the description of the same matters will be omitted.

As shown in FIGS. 57 and 58, the sheath 30 of the present embodiment has
A tube-shaped member is divided into two in the radial direction, and a pair of elastically deformable split pieces 166 and 167 and one end of the split piece 166 and the split piece 167 are connected to each other to have flexibility. The connecting sheet 168 includes a connecting sheet 169 that connects the other ends of the split piece 166 and the split piece 167 and has flexibility. The base ends of the split pieces 166 and 167 are respectively fixed to the tip of the main body 31. Note that the split pieces 166 and 167 and the main body 31 may be formed integrally or separately. There may be.

  First, a state in which the diameter-expanded portion 16 has been expanded will be described with reference to FIG. Each of the split pieces 166 and 167 is a natural state where no external force is applied, and when viewed from the axial direction of the main body 31, the distal end portion is located outside the base end portion, and the split pieces 166 and 167 are viewed as a whole. And the front-end | tip part has spread outside the base end part.

  In addition, the constituent material of the divided pieces 166 and 167 is not particularly limited as long as it is elastically deformable, and examples thereof include a flexible resin material.

  In addition, the constituent material of the divided sheets 168 and 169 is not particularly limited as long as it has flexibility, and examples thereof include a soft resin material and paper.

  As shown in FIG. 57, such an enlarged diameter portion 16 has a reduced diameter, that is, in a state where the split pieces 166 and 167 are elastically deformed, and the needle body 35 is attached to and detached from the distal end portion of the enlarged diameter portion 16. It is installed freely. That is, the needle body 35 is indirectly attached to the distal end portion of the main body 31 via the enlarged diameter portion 16. Further, the diameter-enlarged portion 16 is held in a reduced diameter state by the needle body 35 being attached. Therefore, the needle body 35 also serves as a holding portion. Further, the divided pieces 166 and 167 function as urging portions that urge the reduced diameter enlarged portion 16 in the direction of expanding the diameter.

When the needle body 35 is detached from the enlarged portion 16, the split pieces 166 and 167 are restored to a natural state by the elastic force, and the enlarged diameter portion 16 is enlarged.
A thread 143 is connected to the base end portion of the base end split piece 33.

  Next, main steps of the operation procedure of the puncture apparatus 1 will be described focusing on differences from the first embodiment.

  First, as shown in FIG. 55, the operation member 7 is operated (see FIG. 20), and the medical tube assembly 10 is punctured into the patient.

Next, as shown in FIG. 56, only the tip split piece 32 is further moved in the tip direction.
Next, as shown in FIG. 57, the operating member 7 is operated to remove the insertion portion 71 from the living body. Thus, the main body 31 is disposed in the living body.

  Next, as shown in FIG. 58, the needle body 35 is detached from the distal end portion of the main body 31. Thereby, the division | segmentation piece 166,167 restore | restores to a natural state with the elastic force, and the enlarged diameter part 16 expands a diameter.

  Next, the implant main body 91 is inserted into the main body 31 from the variable diameter shape 16. At this time, since the diameter-changing shape 16 is enlarged, the implant body 91 can be easily and smoothly inserted into the body 31.

  Also according to the seventeenth embodiment, the same effects as those of the fifteenth embodiment described above can be achieved.

<Eighteenth embodiment>
FIG. 59 is a perspective view showing a medical tube according to an eighteenth embodiment of the present invention. FIG. 59 (a) is a perspective view showing a state in which a distal end split piece and a proximal end split piece are assembled, and FIG. [Fig. 11] is a perspective view showing a state in which a distal end divided piece and a proximal end divided piece are divided from each other. FIG. 60 is a view for explaining an example of use of the medical tube shown in FIG. 61 is a cross-sectional view taken along line HH in FIG.

  In the following, for convenience of explanation, the right side in FIGS. 59 to 61 is referred to as “tip”, the left side as “base end”, the upper side as “upper”, and the lower side as “lower”. Further, in FIGS. 59 to 61, for convenience of explanation, a sheath (medical tube) extending in an arc shape is linearly extended and illustrated. In FIGS. 59 to 61, the state maintaining mechanism and the like are not shown for convenience of explanation.

  Hereinafter, the eighteenth embodiment of the medical tube assembly will be described with reference to this figure. However, the difference from the first embodiment will be mainly described, and the description of the same matters will be omitted.

  As shown in FIG. 59, in the sheath 30 of the present embodiment, the distal end split piece 32 of the main body 31 is closer to the end portion (base end portion) of the distal end split piece 32 on the proximal end split piece 33 side than the end portion. A flexible flexible part (first flexible part) 17 is provided. The flexible portion 17 is the most flexible portion of the tip divided pieces 32 (the flexible portion 17 is more flexible than the portion closer to the center than the flexible portion 17 of the tip divided pieces 32).

  Further, the base end split piece 33 has a flexible portion (second flexible portion) 18 that is more flexible than the end portion at the end portion (tip end portion) of the base end split piece 33 on the tip split piece 32 side. Yes.

  Further, the base end split piece 33 has a soft portion (third soft portion) 19 that is more flexible than the end portion at the end (base end portion) on the opposite side to the tip split piece 32 of the base end split piece 33. Have. Each of the flexible portion 19 and the flexible portion 18 is the most flexible portion of the base end split piece 32 (the soft portion 18 is located at a position closer to the center than the soft portion 18 of the base end split piece 33. It is flexible, and the flexible part 19 is more flexible than the central part side of the flexible part 19 of the base end split piece 33). In the present embodiment, the degree of flexibility of the flexible part 18 and the flexible part 19 is the same, but may be different.

  Instead of the flexible portion 19, the distal end divided piece 32 is more flexible than the central portion of the distal end side divided piece 32 at the end (tip portion) opposite to the proximal end divided piece 33 of the distal end divided piece 32. You may have the most flexible flexible part (4th flexible part), and the flexible part 19 and the said 4th flexible part may each be provided.

  Further, the flexible portion 17 has elasticity, is opposed to each other via the central axis of the tip split piece 32, and is a pair of tongue pieces (first tongue pieces) 171 and 172 that can be elastically deformed in directions away from each other. have.

  In addition, the flexible portion 18 has elasticity, is opposed to the central axis of the base end split piece 33, and is a pair of tongue pieces (second tongue pieces) 181 that can be elastically deformed in directions away from each other. 182.

  In addition, the flexible portion 19 has elasticity, is opposed to the central axis of the base end split piece 33, and is a pair of tongue pieces (third tongue pieces) 191 that can be elastically deformed in directions away from each other. 192.

  As shown in FIG. 61, the tongue piece 181 and the tongue piece 182 of the flexible portion 18 are arranged along the direction of the long axis J32.

  Further, the flexible portion 18 is a portion where the degree of flexibility gradually increases from the center side of the base end split piece 33 toward the end side (tip side) of the tip split piece 32 side (degree of softness toward the center side). Has a gradually decreasing portion). In this embodiment, as shown in FIG. 61, the thickness of the tongue piece 182 gradually decreases from the proximal end side toward the distal end side. Similarly, the thickness of the tongue piece 181 decreases from the proximal end side toward the distal end side. It is gradually decreasing.

  Further, the tongue piece 171 and the tongue piece 172 of the flexible portion 17 are arranged along the direction of the long axis J32.

  Further, the flexible portion 17 is a portion where the degree of flexibility gradually increases from the central portion side of the distal end divided piece 32 toward the end portion side (base end side) on the proximal end divided piece 33 side (flexible toward the central portion side). Part of which the degree gradually decreases). In the present embodiment, the thickness of the tongue piece 172 gradually decreases from the distal end side toward the proximal end side, and similarly, the thickness of the tongue piece 171 gradually decreases from the distal end side toward the proximal end side.

  Further, the tongue piece 191 and the tongue piece 192 of the flexible portion 19 are arranged along the direction of the long axis J32.

  In addition, the flexible portion 19 is a portion where the degree of flexibility gradually increases (from the center portion side toward the center portion side) from the center portion side of the base end split piece 33 toward the end portion side (base end side) opposite to the tip end split piece 32. A portion where the degree of flexibility gradually decreases). In the present embodiment, the thickness of the tongue piece 192 gradually decreases from the distal end side toward the proximal end side, and similarly, the thickness of the tongue piece 191 gradually decreases from the distal end side toward the proximal end side.

  The constituent material of the flexible portions 17, 18, and 19 is not particularly limited, and examples thereof include a flexible resin material.

  Note that the constituent material may be the same or different between the flexible portion 17 and the portion other than the flexible portion 17 of the tip split piece 32. Similarly, the constituent materials may be the same or different between the flexible portions 18 and 19 of the base end split piece 33 and the portions other than the flexible portions 18 and 19.

  Each of these flexible portions 17 to 19 is deformed when contacting the implant body 91. That is, each of the flexible portions 17 to 19 is deformed in a direction to release the force when receiving a force from the implant main body 91.

  Specifically, as shown in FIG. 60, when the distal end divided piece 32 and the proximal end divided piece 33 are divided and the implant main body 91 is discharged from the main body 31, the flexible portion 18 of the proximal divided piece 33. The tongue pieces 181 and 182 are elastically deformed so as to open in the direction away from each other, that is, in the direction of the long axis J32. Similarly, the tongue pieces 171 and 172 of the flexible portion 17 of the tip split piece 32 are separated from each other. It is elastically deformed so as to open in the direction, that is, the direction of the long axis J32. Thereby, the implant main body 91 can be easily, smoothly and reliably discharged from the main body 31.

  Further, when the implant body 91 is inserted into the main body 31 from the base end portion of the main body 31, the tongue pieces 191 and 192 of the flexible portion 19 of the base end split piece 33 are elastically deformed in a direction away from each other. Thereby, the implant main body 91 can be easily, smoothly and reliably inserted into the main body 31 from the base end portion of the base end split piece 33.

  In addition, it is preferable that the main body 31 is rigid so that the curvature and lumen of the main body 31 can be maintained in a state where the main body 31 is inserted into the living body (a state where the living body is pierced). The main body 31 communicates with the lumen of the main body 31 over the entire length in a state where the distal end divided piece 32 and the proximal end divided piece 33 are connected.

  As described above, according to the puncture device 1, since the flexible portion 19 is provided at the base end portion of the main body 31, the implant main body 91 can be easily, smoothly and reliably inserted into the main body 31 from the base end portion of the main body 31. Thus, the implant body 91 can be easily and reliably placed in the living body.

  Further, the distal end split piece 32 has the flexible portion 17 at the end of the distal end split piece 32 on the proximal end split piece 33 side, and the proximal end split piece 33 is the end of the proximal end split piece 33 on the distal end split piece 32 side. Since the flexible part 18 is included in the part, the implant body 91 can be easily, smoothly and reliably discharged from the inside of the body 31, whereby the implant body 91 can be easily and reliably placed in the living body. Can do.

  Further, when the implant main body 91 is placed in the living body, it can be dealt with only by a minimally invasive technique such as puncture of the puncture member 3, and it is not necessary to make a large invasive incision or the like. Also, patient safety is high.

  Further, the puncture member 3 can puncture the living body while avoiding the urethra 1300 and the vagina 1400, and the puncture member 3 can be prevented from puncturing the urethra 1300 and the vagina 1400, which is safe.

  Moreover, it prevents the occurrence of complications such as the implant body 91 being exposed in the vagina from the wound created by the incision and the infection from the wound as in the case of the conventional incision of the vagina. It is possible to embed the implant body 91 with certainty.

<Nineteenth embodiment>
FIG. 62 is a perspective view showing a medical tube according to a nineteenth embodiment of the present invention. FIG. 63 is a view for explaining an example of use of the medical tube shown in FIG. In the following, for convenience of explanation, the right side in FIGS. 62 and 63 is referred to as “tip”, the left side as “base end”, the upper side as “upper”, and the lower side as “lower”. In FIGS. 62 and 63, for convenience of explanation, a sheath (medical tube) extending in an arc shape is linearly extended and illustrated. 62 and 63, the state maintaining mechanism and the like are not shown for convenience of explanation.

  Hereinafter, the nineteenth embodiment of the medical tube assembly will be described with reference to this figure. However, the difference from the eighteenth embodiment will be mainly described, and the description of the same matters will be omitted.

  As shown in FIG. 62, in the sheath 30 of the present embodiment, the tongue piece 181 and the tongue piece 182 of the flexible portion 18 are arranged along the direction of the single axis J31. Similarly, the tongue piece 171 and the tongue piece 172 of the flexible portion 17 are aligned along the direction of the single axis J31, and the tongue piece 191 and the tongue piece 192 of the flexible portion 19 are along the direction of the single axis J31. Are lined up.

  When the distal end divided piece 32 and the proximal end divided piece 33 are divided and the implant body 91 is discharged from the main body 31, the tongue pieces 181 and 182 of the flexible portion 18 of the proximal end divided piece 33 are separated from each other. That is, it is elastically deformed so as to open in the direction of the single axis J31, and similarly, the tongue pieces 171 and 172 of the flexible portion 17 of the tip split piece 32 are separated from each other, that is, in the direction of the single axis J31. It is elastically deformed. Thereby, the implant main body 91 can be easily, smoothly and reliably discharged from the main body 31.

  The nineteenth embodiment can provide the same effects as those of the eighteenth embodiment described above.

<20th Embodiment>
FIG. 64 is a sectional view showing a medical tube according to the twentieth embodiment of the present invention. In the following, for convenience of explanation, the right side in FIG. 64 is referred to as “tip”, the left side as “base end”, the upper side as “upper”, and the lower side as “lower”. In FIG. 64, for convenience of explanation, a sheath (medical tube) extending in an arc shape is linearly extended. In FIG. 64, the state maintaining mechanism and the like are not shown for convenience of explanation.

  Hereinafter, the twentieth embodiment of the medical tube assembly will be described with reference to this drawing. The difference from the nineteenth embodiment will be mainly described, and the description of the same matters will be omitted.

  As shown in FIG. 64, in the sheath 30 of the present embodiment, a plurality of cuts 183 are formed on the mutually opposing surfaces of the tongue pieces 181 and 182 of the flexible portion 18.

  Each notch 183 extends in the direction of the long axis J <b> 32 and is arranged in parallel along the axial direction of the base end split piece 33.

  Further, the interval between the adjacent cuts 183 gradually decreases from the proximal end side toward the distal end side. Accordingly, the degree of flexibility of the flexible portion 18 gradually increases from the proximal end side toward the distal end side.

  The flexible portions 17 and 19 are similarly formed with cuts (not shown).

  Also according to the twentieth embodiment, effects similar to those of the nineteenth embodiment described above can be achieved.

  Note that the twentieth embodiment can also be applied to the eighteenth embodiment and the twenty-first embodiment.

<Twenty-first embodiment>
FIG. 65 is a perspective view showing a medical tube according to the twenty-first embodiment of the present invention. In the following, for convenience of explanation, the right side in FIG. 65 is referred to as “tip”, the left side as “base end”, the upper side as “upper”, and the lower side as “lower”. In FIG. 65, for convenience of explanation, a sheath (medical tube) extending in an arc shape is linearly extended. In FIG. 65, the state maintaining mechanism and the like are not shown for convenience of explanation.

  Hereinafter, the twenty-first embodiment of the medical tube assembly will be described with reference to this drawing. However, the difference from the above-described eighteenth embodiment will be mainly described, and the description of the same matters will be omitted.

  As shown in FIG. 65, in the sheath 30 of the present embodiment, the main body 31 has a single tube shape. And the main body 31 has the flexible part 19 more flexible than the base end part in the base end part. The flexible part 19 is the most flexible part of the main body 31 (the flexible part 19 is more flexible than the part on the central part side of the flexible part 19 of the main body 312). Further, the flexible portion 19 has a pair of tongue pieces 191 and 192 that are elastic and are opposed to each other via the central axis of the main body 31 and can be elastically deformed in a direction away from each other.

  Further, the tongue piece 191 and the tongue piece 192 of the flexible portion 19 are arranged along the direction of the long axis J32.

  In addition, the flexible part 19 has a portion where the degree of flexibility gradually increases from the central part side to the base end side of the main body part 31. In the present embodiment, the thickness of the tongue piece 192 gradually decreases from the distal end side toward the proximal end side, and similarly, the thickness of the tongue piece 191 gradually decreases from the distal end side toward the proximal end side.

  The flexible portion 19 may be provided at the distal end portion of the main body 31, or may be provided at each of the distal end portion and the proximal end portion of the main body 31.

  Also according to the twenty-first embodiment, the same effects as in the eighteenth embodiment described above can be obtained.

  The medical tube of the present invention has been described based on the illustrated embodiment. However, the present invention is not limited to this, and the configuration of each part is replaced with an arbitrary configuration having the same function. can do. In addition, any other component may be added to the present invention.

  In the above-described embodiment, the needle body is detachably held on the main body. However, the present invention is not limited thereto, and the needle body is fixed to the main body, for example, the main body and the needle body are integrally formed. May be. In this case, the distal end side opening of the main body can be opened by puncturing the living body with the puncture member and projecting the needle body out of the living body, and then cutting the needle body with a scissors or the like.

  Further, the shape of the main body of the sheath is not limited to the shape of the above-described embodiment, and may be, for example, a linear shape, and the outer shape in a cross section may be a circle or the like.

  Further, the sheath main body may be configured to be separable into a tip split piece (first split tube) and a base end split piece (second split tube), and cannot be separated into a tip end side and a base end side. The configuration, that is, the main body may have a single tube shape.

  The constituent material of the sheath body is not limited to a hard material, and may be, for example, a soft material.

  Moreover, the shape of the insertion part is not limited to the shape of the said embodiment, For example, you may comprise linear form.

  Moreover, in the said embodiment, although the sheath is comprised as a part of puncture member, it is not limited to this. That is, a sheath may be inserted into a through-hole formed in a living body using some means first. Specifically, in correspondence with the first embodiment described above, a puncture device 1 is prepared in which the puncture member 3 is omitted, and the insertion portion 71 is used as a puncture member, and the distal end portion 711 is punctured into the right hip of the patient. Then, after passing through one obturator hole, between the urethra and the vagina, and the other obturator hole in order, it is projected from the left buttocks. Next, the insertion portion 71 is inserted into the interior, the sheath 30 (main body 31) is advanced into the body along the insertion portion 71, and both ends protrude from the body surface H. Next, the insertion portion 71 is removed from the body. Thereby, the sheath 30 is arrange | positioned in the biological body. And if an implant main body is arrange | positioned in the sheath 30 and the sheath 30 is extracted from a body, an implant main body can be detained in the living body like embodiment mentioned above.

  In addition, for example, the distal end portion 711 of the insertion portion 71 is punctured into the right hip of the patient, passes through one obturator hole, between the urethra and the vagina, and the other obturator hole in order, and then from the left hip to the outside of the body. Then, the distal end portion of the sheath 30 is fixed to the distal end portion 711. Next, the distal end portion 711 is rotated in the reverse direction to remove the insertion portion 71 from the body, and the sheath 30 is placed in the living body. And if an implant main body is arrange | positioned in the sheath 30 and the sheath 30 is extracted from a body, an implant main body can be detained in the living body like embodiment mentioned above.

  In the above-described embodiment, the configuration in which the main body of the puncture member is placed in the living body and then the implant main body is inserted into the main body has been described. However, the present invention is not limited to this. It may be accommodated in. In this case, for example, it is preferable to fix the thread located on the needle tip side of the two threads of the implant body to the needle tip. Thereby, when the needle tip is removed from the main body, the thread can be protruded out of the main body. Therefore, subsequent fine adjustment of the arrangement of the implant body can be performed smoothly.

  Further, in the above-described embodiment, the case where the puncture device is applied to a device used when an implantable implant for treating urinary incontinence in women is embedded in a living body has been described. However, the use of the puncture device is limited thereto. Is not to be done.

  For example, the present invention relates to excretion disorder (urinary urgency, frequent urination, urinary incontinence, stool incontinence, urinary retention, difficulty in urination, etc.), pelvic organ prolapse, vesicovaginal fistula, urethral vagina, as the pelvic floor muscles weaken Pelvic floor diseases including epilepsy, pelvic pain, etc. are included in the application target. Pelvic organ prolapse includes diseases such as cystocele, small intestinal aneurysm, rectal aneurysm, and uterine prolapse. Alternatively, diseases such as anterior vaginal wall prolapse, posterior vaginal wall prolapse, vaginal stump prolapse, and vaginal vault prolapse are classified according to the vagina wall site being removed.

  The hypermovable tissue includes the bladder, vagina, uterus, intestine and the like. Micro-movable tissues include bones, muscles, fascia, ligaments and the like. In particular, in pelvic floor disease, it includes obturator fascia, coccyx fascia, base ligament, sacral uterine ligament, sacral ligament, and the like.

  In pelvic floor disease, procedures that connect hypermovable tissue to micromovable tissue include retropubic sling surgery, transobturator sling surgery (transobturator tape; TOT), and transvaginal mesh surgery (Tension-free Vaginal). Mesh; TVM), elevation using the sacral uterine ligament (Uterosacral Ligament Suspension; USLS), fusion using the sacrospinous ligament (SSLF), fixation using the iliac coccyx fascia, tailbone Includes fusion using the fascia.

DESCRIPTION OF SYMBOLS 1 Puncture apparatus 10 Medical tube assembly 2 Frame 21 Bearing part 211 Through-hole 22 Guide part 221 Guide groove 222 Front end side opening 223 Base end side opening 23 Connection part 24 Fixing part 243 Recess 244 Male screw 3 Puncture member 3A Puncture member 30 Sheath 31 Body 310 Recess 311 Through-hole 312 Groove 313 Groove 314 Groove 315 Engagement hole 316 Engagement hole 317 Engagement hole 318 Engagement hole 319 Tapered part 32 Front end split piece 321 Front end side opening 322 Base end side opening 33 Base end split Piece 331 distal end opening 332 proximal opening 34 state maintaining mechanism 34C state maintaining mechanism 34D state maintaining mechanism 34E state maintaining mechanism 34F state maintaining mechanism 34G state maintaining mechanism 34H state maintaining mechanism 341 thread 341a knot 341b knot 342a hole 342b hole 342c hole 342d hole 342e hole 342f hole 342g hole 42h hole 342i hole 342j hole 342k hole 342l hole 343a protrusion 343b protrusion 344 stylet 345 exposure hole 346 exposure hole 347 slit 347a part 347b part 348 hole 349 thread 35 needle body 351 needle tip 352 base end part 352a hole 353 engagement part 36 Fragile portion 361 perforation 371 outer tube 372 inner tube 38 wire 381 distal end hook 382 proximal end hook 39 wire 4 urethral insertion member 40 support portion 41 urethral insertion portion 411 insertion portion 412 non-insertion portion 42 balloon 43 balloon port 44 suction hole 45 suction Port 46 Marker 47 Urine discharge part 471 Drainage hole 48 Urine discharge port 5 Vaginal insertion member 50 Support part 501 Male screw 51 Vaginal insertion part 511 Insertion part 511a Upper surface 511b Lower surface 512 Non-insertion part 53 Recessed part 54 Suction port 57 Ma Car 59 suction holes 6 inserter 60 supports 7 operating member 71 the insertion portion 711 tip 712 tip 712a area increasing portion 712b area reduced portion 712c boundary 713 rib 72 connecting portion 73 the shaft portion 81 anchors (second anchors)
811 Base portion 812 Insertion hole 813 Claw portion 814 Claw portion 82 Anchor (first anchor)
821 Base part 822 Insertion hole 823 Claw part 824 Claw part 9 Implant 91 Implant body 911 Body part 912 Band 92 Packaging material 121 Bag body 122 Opening 123 Recess 13 Rotation restricting part 141 Marker 142 Thread 143 Thread 151 Groove 152 Groove 16 Widening part 161 Bone member 162 Bone part 163 Support part 164 Sheet 165 Sheet 166 Split piece 167 Split piece 168 Link sheet 169 Link sheet 17 Flexible part 171 Tongue piece 172 Tongue piece 18 Flexible part 181 Tongue piece 182 Tongue piece 183 Notch 19 Flexible part 191 Tongue piece 192 Tongue 1100 Pelvis 1101 Closure hole 1102 Closure hole 1200 Pubic joint 1300 Urethra 1310 Bladder 1400 Vagina 1410 Vaginal anterior wall 2000 Syringe A1 Inner periphery A2 Outer periphery A3 Surface A4 Back surface D Spacing distance H Body surface J1 Axis J2 Axis J31 Short axis J32 Long axis J 2 ′ extension line J5 central axis f1 plane f2 plane f9 plane L2 length O center P intersection S1 area S2 area S3 space S4 center S5 safety zone r1 minimum curvature radius r2 maximum curvature radius W width W1 width W2 width θ1 inclination angle θ2 Inclination angle θ3 Inclination angle θ4 Center angle θ5 angle

Claims (9)

A medical tube having a tubular body inserted with an implant to be placed in a living body,
The said main body has a flexible part more flexible than this edge part in the at least one edge part, The medical tube characterized by the above-mentioned.   The medical tube according to claim 1, wherein the flexible portion is deformed when contacting the implant.   The medical tube according to claim 2, wherein the flexible portion is deformed in a direction to release the force when receiving a force from the implant.   The medical tube according to any one of claims 1 to 3, wherein the flexible portion has a portion in which a degree of flexibility gradually increases from a central portion side of the main body toward the one end portion side. A medical tube having a tubular body inserted with an implant to be placed in a living body,
The main body has a first divided tube and a second divided tube that can be divided in the axial direction of the main body,
The first divided tube has a first flexible portion that is more flexible than the end portion at at least one end portion of the first divided tube;
The second divided tube has a second flexible portion that is softer than the end portion at at least one end portion of the second divided tube.   The medical tube according to claim 5, wherein each of the first flexible portion and the second flexible portion is deformed when contacting the implant.   The medical tube according to claim 6, wherein each of the first flexible portion and the second flexible portion is deformed in a direction in which the force is released when a force is received from the implant. The first flexible portion has a portion where the degree of flexibility gradually decreases toward the central portion of the first divided tube;
The medical tube according to any one of claims 5 to 7, wherein the second flexible portion has a portion where the degree of flexibility gradually decreases toward the central portion of the second divided tube. The body has a curved portion;
The main body is rigid so that the curvature and lumen of the main body can be maintained in a state of being inserted into a living body, and the first divided tube and the second divided tube are connected. The medical tube according to any one of claims 5 to 8, wherein the lumen of the main body communicates over the entire length.

Images