JP6168104B2 - Puncture needle - Google Patents

Description

  The present invention is a surgical operation of a puncture needle dedicated to body cavity puncture, such as surgery TVT (Tension-free Vagina Tape), TOT (Trans-Obrator Tape), and pelvic organ prosthesis TVM (Tension-free Vaginal Mesh) for treating urinary incontinence in women. It relates to the retention of yarns and mesh guide yarns.

  Many women's urinary incontinence is stress urinary incontinence. This woman with stress urinary incontinence incontinence during normal daily activities, such as coughing, sneezing, laughing and standard exercise.

  Stress urinary incontinence is caused by functional defects in the tissues or ligaments that connect to the urethra and pubic bone, and common factors include repetitive tension in the muscles in the pelvis, childbirth, and muscle tension in the pelvis. Loss and loss of female hormones. As a surgical treatment for stress urinary incontinence, TVT (Tension-free Vagina Tape) is the mainstream, assuming a ligament passing through both sides of the pubic bone and under the urethra, the pubic urethra ligament, and a tape made of polypropylene fiber However, in order to deliver this tape, it is necessary to use two relatively thick and long-pointed puncture members from the vagina to the lower abdomen. When inserting a member, it was a groping work, and there was a risk of damaging structures in the pelvis such as the bladder, blood vessels, muscles, and nerves. Moreover, in order to prevent these damages, it was necessary to repeat visualization with a cystoscope, and there was a disadvantage that a long time was required for the operation.

  On the other hand, in addition to the above-mentioned TVT operation, a TOT (Trans Obturator Tape) operation has been proposed as a new operation method. This surgical method is constituted by the following steps.

(1) After performing anesthesia, a pair of left and right obturator skin and the anterior wall of the vagina are opened. (The anterior wall of the vagina creates a subcutaneous tunnel that allows fingers to enter.)
(2) A dedicated puncture needle is punctured from the obturator hole and put out through the back of the pubic bone to the anterior vagina wall. (At this time, put your finger into the subcutaneous tunnel and guide the puncture needle.)
(3) After the puncture needle is guided out of the vagina from the vagina front wall, a tape is put on the groove at the tip of the puncture needle, the puncture needle is pulled out of the skin, and the tape is pulled out from the closing hole.
(4) Repeat the above operation on the other closing hole side and pull out the tape in the same way.
(5) After finely adjusting the tension of the tape pulled out from the closed hole, the skin and vagina are sutured and the operation is completed.
The above-described surgical method shows a method of taking out the needle from the closed hole into the vagina (outside-in), and conversely, the method of taking out the needle from the vagina into the closed hole (inside-out) is also performed from the same process.

  Similar to urinary incontinence, another disease that affects women is pelvic organ prolapse. This is a disease in which the pelvic organs such as the uterus and bladder that are supported in a hammock by the pelvic floor muscles deviate from the vagina due to weakness of the pelvic floor muscles due to aging, so-called uterine prolapse or cystocele . As a method for repairing the pelvic organ prolapse, a reinforced vagina wall stitching operation in which the vagina wall is incised and the portion that has deviated is sewn has been performed. In recent years, as an alternative technique, pelvic organ prolapse surgery TVM (Tension-free Vaginal Mesh) was adopted, and the entire pelvic floor was supported in a hammock shape with a polypropylene mesh, thereby preventing the escape of the pelvic organs from the vagina.

  However, the above-mentioned TVM surgery also requires a blind puncture operation using a dedicated puncture needle in the same manner as the operations TVT and TOT for treating urinary incontinence. There was a risk of not being able to grasp accurately, damaging the bladder, blood vessels, intestinal tract, etc. and causing serious complications. Furthermore, in this pelvic organ prosthesis TVM, it is necessary to pull the thread passed through the hole provided at the tip of the puncture needle with a hook and pull it out of the vagina. Since the tip of the needle is a deep part in the body, the field of view is poor due to the exclusion of surrounding organs, and it is dark and the position of the thread varies every time the puncture operation is performed, so it is difficult and time consuming to hook with the hook There was also.

  Therefore, the present inventors have completed a puncture needle that has been improved so that it can be easily threaded with a hook in urinary incontinence surgery TOT, TVT and pelvic organ prolapse surgery TVM (see, for example, Patent Document 1 and Patent Document 2). ).

Japanese Patent No. 5625164 Japanese Patent No. 5696337

  However, since the puncture needles described in Patent Document 1 and Patent Document 2 are threaded on the hooks in an environment with a poor visual field as in the past, the operation is still difficult.

  Further, although Patent Document 2 is provided with a rotation restricting means, the tip of the puncture needle is located in the living tissue until the tip of the puncture needle reaches the target site after puncturing the living tissue. There was a problem that the position was unknown and technical guidance became difficult.

  In view of the above problems, as a result of intensive research, the present inventors have been able to draw out the thread passed through the tip of the puncture needle in a short time in urinary incontinence surgery TOT, TVT and pelvic organ prolapse surgery TVM. It aims at providing the safe puncture needle which can regulate rotation of a needle.

  For this reason, the puncture needle of the present invention includes a curved puncture portion having a needle portion on one end side, and an arm portion provided so as to be rotatable with respect to the puncture portion via a rotation portion. A groove portion formed along the longitudinal direction of the groove portion, a communication hole communicating with the groove portion provided in the needle portion, a long hole orthogonal to the communication hole, and a recess provided at a position symmetrical to the groove portion. A target provided with a groove, an opening through which the needle part provided at the tip of the arm part can be inserted, and a rotation restricting means fixed to the arm part, and a thread is hung on the target. The first feature is that one hooking claw is provided.

  Further, a second feature is that the toe of the hooking nail is provided so as to protrude in the same direction as the inserted needle part, and the toe of the hooking nail protrudes in a direction opposite to the inserted needle part. The third feature is that it is provided as described above.

  A fourth feature is that the hooking claw is slidably provided along the arm portion, and a fifth feature is that the hooking claw is provided with a return portion.

  In addition, a sixth feature is that the target is provided with a guide claw having a toe directed in a direction opposite to the hook claw.

  Further, a seventh feature is that the rotation restricting means includes a rotation adjusting means capable of adjusting the rotation stepwise.

  Still further, an eighth feature is that the puncture portion, the arm portion, and the rotation portion are detachable from each other.

  According to the puncture needle according to the present invention, since the hooking claw on which the thread is hung is provided, the thread can be hung on the hooking claw only by rotating the puncture needle. In addition to being unnecessary, the thread passed through the tip of the puncture needle can be pulled out in a short time, and an excellent effect of improving work efficiency is achieved.

  In addition, since the rotation restricting means of the puncture needle can be adjusted stepwise, the needle part can always be arranged at a predetermined position, and an excellent effect is obtained that the location of the needle part can be confirmed.

  Further, in the puncture needle according to the present invention, since the puncture portion, the arm portion, and the rotating portion are detachable from each other, the puncture needle is disassembled, and cleaning and sterilization operations before and after surgery are performed. It can be performed. Therefore, it is possible to easily perform cleaning / sterilization work.

It is a front view which shows 1st embodiment of the puncture needle which concerns on this invention. It is a right view which shows 1st embodiment of the puncture needle concerning this invention. It is a bottom view which shows 1st embodiment of the puncture needle concerning this invention. It is an A direction arrow directional view of FIG. 1 is a perspective view showing a first embodiment of a puncture needle according to the present invention. (A) which shows the needle part front-end | tip structure of 1st embodiment of the puncture needle concerning this invention is a partial enlarged view of the front, (b) is a B direction arrow view of (a), (c) is (a). It is CC sectional drawing of. It is sectional drawing which shows the needle part front-end | tip structure of 1st embodiment of the puncture needle concerning this invention. It is sectional drawing which shows the needle part tip structure of 2nd embodiment of the puncture needle concerning this invention. It is a principal part enlarged view which shows 3rd embodiment of the puncture needle concerning this invention. It is sectional drawing which shows the needle part front-end | tip structure of 3rd embodiment of the puncture needle based on this invention. (A) which shows the structure of the needle part front-end | tip of 4th embodiment of the puncture needle concerning this invention, and a target site | part is an expanded perspective view, (b) is a perspective view from a different direction from (a). . It is sectional drawing which shows the needle part front-end | tip structure of 4th embodiment of the puncture needle based on this invention. It is a front view which shows 5th embodiment of the puncture needle concerning this invention. It is the DD arrow line view of FIG. It is a front view explaining the movement of 5th embodiment of the puncture needle concerning this invention. It is sectional drawing which shows the needle part front-end | tip structure of 6th embodiment of the puncture needle based on this invention.

(First embodiment)
The first embodiment of the present invention will be described below with reference to FIGS. 1 to 7, but it goes without saying that the present invention is not limited to this embodiment.

  As shown in FIG. 1, the puncture needle 1 of the present invention has a needle portion 21 on one end side, a rod-like puncture portion 2 that is curved as a whole, and a rotating portion 4 provided at the base of the puncture portion 2. And a target 32 provided on the distal end (needle portion 21) side of the arm portion 3 and is integrally formed in a direction perpendicular to the rotation axis of the rotation portion 4. The puncture unit 2 and the arm unit 3 rotate relative to each other, and the distal end portion (needle unit 21) of the puncture unit 2 is always guided to the target 32. The description will be made with the left side in FIG. 1 as the “base end” and the right side as the “tip”, with FIG. 1 as the front view and FIG. 2 as the right side.

  The puncture unit 2 is obtained by processing a rod-shaped body made of various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy. The puncture portion 2 is formed by forming a bent portion 23 in this metal rod-shaped body and processing it in a predetermined arc shape centering on the rotation axis of the rotation portion 4 toward the distal end side. An arc-shaped part 2a and a straight part 2b are provided. As shown in the broken line in FIG. 1 and FIG. 2, the groove 212 has a predetermined depth in the longitudinal direction (axial direction of the needle portion 21) from the vicinity of the bent portion 23 of the curved puncture portion 2 toward the needle portion 21. It is engraved, and it is possible to allow the yarn to follow the groove 212. For this reason, the thread can enter the living tissue together with the puncture unit 2 without the thread appearing on the outer surface of the puncturing unit 2, and damage to the living tissue due to friction between the thread and the living tissue can be prevented. In addition, the puncture part 2 may be solid or may be a tubular hollow.

  The puncture unit 2 is formed with a sharp needle portion 21 via a reduced diameter portion 22 and is configured to prevent damage to living tissue as much as possible. The sharpened shape of the needle portion 21 may be an obtuse angle that allows entry into the living tissue without damaging the living tissue. As shown in FIG. 6, the long hole 214 is drilled in the direction perpendicular to the axis of the puncture unit 2 at the distal end of the puncture unit 2 (near the needle unit 21). A communication hole 213 is formed in a direction orthogonal to the opening direction of the long hole 214. The communication hole 213 is integrally formed so as to be connected to the groove portion 212, and the yarn along the groove portion 212 is introduced into the long hole 214 through the communication hole 213.

  Further, as shown in FIG. 6, a recessed groove 215 into which a later-described hooking claw 322 enters is formed at a position symmetrical to the groove portion 212. As shown in FIGS. 6A and 6C, the recessed groove 215 is engraved with a predetermined depth and a predetermined width in the longitudinal direction toward the needle portion 21 (the axial direction of the needle portion 21). In addition, since the tip of the hooking nail 322 is in close contact with the recessed groove 215, the hanging portion of the thread is easily hooked on the hooking nail 322.

  A gripping part 5 is provided in the vicinity of the bent part 23 of the puncture part 2 so that the turning operation of the puncture part 2 can be performed smoothly. As shown in FIGS. 1 to 5, the grip portion 5 includes a substantially rectangular parallelepiped base portion 51 fixed to the puncture portion 2 and a columnar shape projecting toward the base end side of the base portion 51. And a knob 52. As shown in FIG. 4, the base 51 is provided with a thread insertion part 511, and the thread along the groove 212 is passed to the base end side through the thread insertion part 511. As shown in FIG. 5, the thread insertion part 511 is formed by forming a circular hole on the upper end side of the base part 51 and then performing a notch process from the upper surface of the base part 51 to the hole. The thread can be inserted into the drilled hole through the formed and notched portion.

  The base end portion 24 of the puncture unit 2 is detachably attached to the rotation unit 4. Further, one end side of the arm portion 3 is fixed to the rotating portion 4 by welding. Since the rotation part 4 is fixing the two substantially columnar bodies to which the one end side of the base end part 24 and the arm part 3 were respectively attached by the knurled screw 41, it can be rotated from the base end to the front end direction, and It can be disassembled by removing the knurled screw 41.

  As shown in FIG. 1, the arm portion 3 is obtained by processing a rod-like body made of the same material as the puncture portion 2 into a substantially U-shape. The length of the straight part 3a of the arm part 3 is 20 mm or 40 mm, and is appropriately selected depending on the method of puncturing (forward puncture, backward puncture). One end side of the arm portion 3 is fixed to the rotating portion 4 by welding, a target 32 is attached to the other end side, and the needle portion 21 is guided to the target 32. As shown in FIGS. 3 and 7, the target 32 is a disc-like plate-like body having an opening 321 through which the tip of the puncture part 2 can be inserted, and is fixed to the other end of the arm part 3. Yes. On the upper surface of the target 32, a hooking claw 322 is fixed to the upper end of the arm portion so that the toe protrudes downward from the opening portion 321 (in the same direction as the inserted needle portion). When the thread passes through the opening 321, the hooking claw 322 fits into the recessed groove 215, and the hooking claw 322 enters the ring-like hanging thread extending from the long hole 214 to the recessed groove 215. When the needle unit 21 is pulled out from the target 32 together with the puncture unit 2, the thread hung on the hooking nail 322 is held by the target 32, and the thread can be reliably caught.

  The arm portion 3 is provided with a rotation restricting means 31, and the puncture portion 2 and the arm portion 3 are rotated relative to each other at a position where the needle portion 21 does not pass through the target 32 and damage the body tissue. Is regulated. The rotation restricting means 31 is fixedly provided on the other end side of the support member 311 and the substantially S-shaped support member 311 whose one end side is fixed to the curved portion of the arm portion 3 processed into a substantially U shape. The stopper 312 is fitted to the straight portion 2b. The arm part 3 and the rotation restricting means 31 are made by processing the same material as that of the puncture part 2. The stopper 312 is formed so as to be fitted to the outer periphery of the straight portion 2b by winding a plate-like body around the outer periphery of the support member 311 and folding the end portion outward.

  A finger pad 33 having a width wider than the diameter of the straight part 3a is fixed on the lower surface side at the distal end side (target 32 side) of the straight part 3a. It is configured to hold firmly so as not to shake.

  In the first embodiment configured as described above, as shown in FIGS. 5 and 6, the thread is inserted into the thread insertion part 511, and the needle part is inserted into the groove part 212 provided on the side periphery of the puncture part 2. 21, through the communication hole 213 into the long hole 214, pulled out from one of the long holes 214, traversed the recessed groove 215 located on the back side of the communication hole 213, and again from the other long hole 214 to the communication hole It returns to 213 and uses it along the groove part 212 again. By hooking the yarn with the hooking claws 322 protruding downward in the opening portion 321 of the target 32, the yarn searching time is not required and the yarn can be reliably caught. Further, the puncture unit 2 can move while drawing a predetermined arc-shaped trajectory centered on the rotation axis of the rotation unit 4.

(Second embodiment)
Next, a second embodiment of the present invention will be described based on FIG. In addition, the same code | symbol is attached | subjected to the location same as 1st embodiment, and the difference with 1st embodiment is mainly demonstrated below.

  As shown in FIG. 8, the hooking claw 322 is fixed to the lower end of the straight part 3a so that its toe protrudes upward from the opening 321 (opposite to the inserted needle part). When 21 passes through the opening 321, the hooking claw 322 fits into the recessed groove 215, and the hooking claw 322 enters the ring-like hanging thread. A return portion 323 is formed in the hooking nail 322, and when the needle portion 21 is pulled out from the target 32 together with the puncture portion 2, the thread hooked on the hooking nail 322 can be reliably caught by the return portion 323. Become.

(Third embodiment)
Next, a third embodiment of the present invention will be described based on FIG. 9 and FIG. In addition, the same code | symbol is attached | subjected to the location same as 1st embodiment, and the difference with 1st embodiment is mainly demonstrated below.

  As shown in FIG. 9, the third embodiment of the present invention is configured such that the hooking claws 322 are slidable back and forth along the straight portion 3a. In the present embodiment, the hooking claw 322 is a cylindrical body having one end formed in a conical shape, and the fixing part 324 and the operation part 325 sandwich the straight part 3a and the hooking claw 322, and are attached to the straight part 3a. . An adjustment bar 322a is provided on the peripheral surface of the hooking claw 322, and the hooking claw 322 can be slid back and forth by selecting and hanging the adjustment bar 322a in a plurality of grooves provided in the operation unit 325. Yes. Therefore, for example, as shown in FIG. 10, when the needle portion 21 passes through the opening portion 321, the hooking claw 322 is slid to the position indicated by the alternate long and short dash line in FIG. Configured to prevent. After the needle portion 21 has passed through the aperture portion 321, the hook claw 322 is returned to its original position (the position indicated by the solid line in FIG. 10), so that when the needle portion 21 passes through the aperture portion 321 again, the thread Can be hung on the hanging claw 322.

  In the third embodiment, as shown in FIG. 10, the upper surface side of the target 32 of the aperture 321 has a bowl shape, and even if the puncture route of the puncture unit 2 is displaced, the aperture 321 is reliably It is configured to pass through.

(Fourth embodiment)
Next, a fourth embodiment of the present invention will be described based on FIG. 11 and FIG. In addition, the same code | symbol is attached | subjected to the location same as 1st embodiment, and the difference with 1st embodiment is mainly demonstrated below.

  In the fourth embodiment of the present invention, as shown in FIG. 11A and FIG. 12, the hooking claw 322 is provided in the same manner as in the first embodiment, and the guide claw 326 opens the toe. It is fixed to the lower end of the straight portion 3a so as to protrude upward from the portion 321 (the direction opposite to the hooking claws 322). Further, the flattened portion 216 is cut at a position where the recessed groove 215 in the first embodiment is provided. As shown in FIG. 12, when the needle portion 21 is passed through the opening portion 321 of the target 32, the hooking claw 322 and the guide claw 326 are respectively fixed to the flattening portion 216 so as to be close to each other. The angle of the toe is adjusted so that the claw 322 is at an acute angle with respect to the plane of the flattening portion 216 and the guide claw 326 is substantially parallel to the plane of the flattening portion 216. The toe 326 is configured to cross each other in a side view.

  In the fourth embodiment, as shown in FIG. 12, when the needle portion 21 passes through the opening portion 321, a thread-like droop of thread extending from the long hole 214 to the flattening portion 216 is generated in the guide claw 326. When the needle portion 21 is pulled out from the opening portion 321, the thread guided by the guide claw 326 is hooked on the hook claw 322 and the thread remains on the target 32.

(Fifth embodiment)
Next, a fifth embodiment of the present invention will be described with reference to FIGS. In addition, the same code | symbol is attached | subjected to the location same as 1st embodiment, and the difference with 1st embodiment is mainly demonstrated below.

  In the fifth embodiment of the present invention, as shown in FIG. 13, a rotation adjusting means 34 that is slidable along the straight portion 2 b is provided, and the stage before the needle portion 21 reaches the target 32. Moreover, it is comprised so that the mutual position of the puncture part 2 and the arm part 3 can be adjusted. As shown in FIGS. 13 and 14, the rotation adjusting means 34 includes a support member 341 to which the stopper 312 is fitted, and a stopper 342 fixed to the support member 341 and fitted to the straight portion 2b. Is done.

  As shown in FIG. 14, the stopper 312 is formed by winding a plate-like body around the outer periphery of the support member 341 on a columnar support member 341, folding the end portion outward, and caulking the outer periphery of the straight portion 2b. It is formed so that it may fit. At this time, the stopper 312 is fitted to the straight portion 2b and can be easily detached by caulking so that the width W of the convex portion 343 formed by folding is slightly smaller than the diameter of the straight portion 2b. Become. The support member 311 in the first embodiment and the support member 311 in the present embodiment have the same member shape and material, but have different member lengths. In the fifth embodiment of the present invention configured as described above, as shown in FIG. 15, the stopper 342 is slid along the straight portion 2 b until the needle portion 21 passes the target 32. The rotating unit 4 can be rotated. Therefore, by operating the stopper 342 and adjusting the position of the needle part 21 stepwise, even if the needle part 21 is located in the living tissue and the location of the needle part 21 is blind, it is always a predetermined position. The needle portion 21 can be disposed on the surface.

(Sixth embodiment)
Next, a sixth embodiment of the present invention will be described with reference to FIG. In addition, the same code | symbol is attached | subjected to the location same as 1st embodiment, and the difference with 1st embodiment is mainly demonstrated below.

  As shown in FIG. 16, in the sixth embodiment, like the first embodiment, the toe 322 c of the hooking claw 322 is provided so as to face the same direction as the needle portion 21, and the toe 322 c is the opening portion 321. A hooking claw 322 is fixed to the straight portion 3a. A thread holding groove 322b is provided at the base end of the toe 322c. The groove width of the thread holding groove 322b is formed to be equal to or larger than the thickness of the thread used in the operation.

  In the sixth embodiment configured as described above, since the thread is securely fitted into the thread holding groove 322b, the needle part 21 is separated from the target 32 by rotating the puncture part 2, It is possible to prevent the yarn from separating from the hooking claws 322 and to hold the yarn in a predetermined position. Further, the thread holding groove 322b in the sixth embodiment is combined with, for example, the first embodiment, the fourth embodiment, and the fifth embodiment, and the thread holding groove 322b is provided in the hooking nail 322. Is also possible.

  As described above, according to the tip portion of the puncture needle of the present invention and the portion for holding the thread, the hooking claw for hooking the thread is provided on the target, so that the thread is hooked on the hooking claw only by rotating the puncture needle. It is possible to reduce the time required for urinary incontinence surgery TVT, TOT and pelvic organ prolapse surgery TVM.

  The gist of the present invention is that the claw is provided on the target 32 and the thread pulling operation that has been conventionally performed with the hook is automatically threaded. Therefore, by combining the above-described embodiments, for example, the hook portion 322 in the first embodiment is provided with the return portion 323 shown in the second embodiment, and for example, the first embodiment or the fourth embodiment. In the third embodiment. The aperture shape of the aperture portion 321 of the target 32 may be a bowl shape. Thus, the present invention is not limited to the present embodiment, and it is obvious that various improvements can be made by combining the present embodiment.

DESCRIPTION OF SYMBOLS 1 Puncture needle 2 Puncture part 2a Arc-shaped part 2b Straight part 21 Needle part 212 Groove part 213 Communication hole 214 Long hole 215 Recessed groove 216 Chamfering part 22 Reduced diameter part 23 Bending part 24 Base end part 3 Arm part 3a Straight part 31 Rotation restricting means 311 Support member 312 Stopper 32 Target 321 Opening portion 322 Hanging claw 322a Adjustment bar 322b Thread holding groove 322c Toe 323 Return portion 324 Fixing portion 325 Operation portion 326 Guide claw 33 Finger holding portion 34 Rotation adjustment means 341 Support member 342 Stopper 4 Rotating part 41 Knurled screw 5 Holding part 51 Base part 511 Thread insertion part 52 Knob part

Claims (8)

  A groove portion formed along a longitudinal direction of the puncture portion, comprising: a curved puncture portion having a needle portion on one end side; and an arm portion provided to be rotatable with respect to the puncture portion via the rotation portion A communication hole communicating with the groove provided in the needle portion, a long hole orthogonal to the communication hole, a recessed groove provided at a position symmetrical to the groove, and provided at a tip of the arm portion. A target provided with an opening through which the needle portion can be inserted, and a rotation restricting means fixed to the arm portion, and at least one hooking claw for hanging a thread on the target. A puncture needle.   The puncture needle according to claim 1, wherein a tip of the hook nail is provided so as to protrude in the same direction as the inserted needle portion.   The puncture needle according to claim 1, wherein a tip of the hooking nail is provided so as to protrude in a direction opposite to the inserted needle portion.   The puncture needle according to claim 1, wherein the hooking nail is provided so as to be slidable along the arm portion.   The puncture needle according to claim 2, wherein the hooking nail includes a return portion.   The puncture needle according to claim 2, wherein a guide claw with a toe pointed in a direction opposite to the hook claw is provided on the target.   The puncture needle according to any one of claims 1 to 6, wherein the rotation restricting means includes a rotation adjusting means capable of adjusting the rotation stepwise.   The puncture needle according to any one of claims 1 to 7, wherein the puncture portion, the arm portion, and the rotation portion are detachable from each other.

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