The present disclosure generally relates to a urethral-insertion device.
In a patient suffering from urinary incontinence, particularly stress urinary incontinence, urine leakage can occur due to an abdominal pressure exerted during a normal exercise or by laughing, coughing, sneezing or the like. This can be attributable, for example, to loosening of the pelvic floor muscle, which is a muscle for supporting the urethra, caused by childbirth or the like.
For treatment of urinary incontinence, surgical therapy can be effective, in which there is used, for example, a tape-shaped implant called “sling,” and the sling is placed indwelling in the body, so as to support the urethra thereby (see, for example, Japanese Patent Laid-Open No. 2010-99499). In order to put a sling indwelling in the body, an operator incises the vagina with a surgical knife, dissects a biological tissue between the urethra and the vagina, and forms a puncture-through hole for providing communication between the dissected biological tissue and the exterior, by use of a puncture needle. Then, the sling can be inserted into the puncture-through hole, to be placed to indwell in the dissected biological tissue in the body.
A urethral-insertion device is disclosed by which puncturing of a living body tissue by a puncture needle in the process of placing an embeddable implant (sling) for treatment of urinary incontinence indwelling into a living body can be performed relatively accurately and safely.
In accordance with an exemplary embodiment, a urethral-insertion device configured to be inserted into a urethra is disclosed, comprising: an elongated main body; a bladder suction port adapted to attract a bladder by suction, the bladder suction port being located on the main body; and a urethra suction port adapted to attract a urethra wall by suction, the urethra suction port being located on a distal side of the bladder suction port.
In accordance with an exemplary embodiment, a method is disclosed of placing a sling for use in treatment of urinary incontinence indwelling into a living body comprising: inserting a urethral-insertion device into a urethra; attracting by suction an inner wall of a bladder by a bladder suction port of the urethral-insertion device; moving a bladder from an original position of the bladder; and placing the sling indwelling into the living body between a vagina and the urethra.
Hereafter, the urethral-insertion device of the present disclosure will be described in detail on the basis of preferred embodiments of the disclosure shown in the attached drawings.
One example of a sling (mesh) 9 to be embedded in a living body will be described below.
The sling 9 as shown in
As illustrated in
The sling 9 configured as above is accommodated in a disinfected wrapping material in an unused state thereof. By this, the sling 9 can be prevented against contamination. The material constituting the sling 9 is not particularly limited; for example, any of various biocompatible resin materials such as polypropylene, polyester, nylon, etc. or fiber or the like thereof can be used. While the sling 9 has been described, the sling 9 is not restricted to the net-shaped one so long as it can exhibit the same or similar effect to the above-mentioned.
One example of a urethral-insertion device configured to be inserted into a urethra 1100 will be described.
A first embodiment of a urethral-insertion device 100 shown in
The shaft 120 can include a bladder suction port 134 for attracting a bladder by suction, urethra suction ports 133 disposed on the proximal side of the bladder suction port 134 and attracting a urethra 1100 by suction, an ultrasonic marker 135 disposed opposite to the bladder suction port 134, and a scale 132 disposed on the proximal side of the urethra suction ports 133. The ultrasonic marker 135 can be used to indicate the position of the bladder suction port 134 in a living body. In addition, the scale 132 can be used for measuring the length of insertion of the shaft 120 of the urethral-insertion device 100 inserted in the urethra 1100.
The length of the urethral-insertion device 100 is not specifically restricted, but may be appropriately set according to the length of the patient's urethra 1100, the shape of the patient's bladder 1200, and the like. In view of the fact that the length of a female's urethra 1100 is generally about 30 mm to 50 mm, the length of the urethral-insertion device 100 is preferably, for example, about 50 mm to 300 mm.
It can be preferable, for example, that the urethral-insertion device 100 is in the form of a rigid and straight pipe.
The hub 110 is located on the proximal side of the shaft 120, and can include a mark 111 and a port 131. The mark 111 can be used for indicating the positions of the urethra suction ports 133 and the bladder suction port 134, namely, for indicating the position of the shaft 120 in the circumferential direction. In addition, the port 131 is connected to the urethra suction ports 133 and the bladder suction port 134 through a lumen of the shaft 120. When a suction pump (not shown) is connected to the port 131 and is operated to apply suction, a suction force is generated at each of the urethra suction ports 133 and the bladder suction port 134.
Therefore, when the suction pump is operated in a condition in which the urethral-insertion device 100 is inserted in the urethra 1100 (more specifically, in a condition in which the urethra suction ports 133 are disposed within the urethra 1100 and the bladder suction port 134 is disposed in the bladder 1200), a urethral wall can be fixed by suction onto the urethra suction ports 133, and a bladder wall can be fixed by suction onto the bladder suction port 134. In addition, where a plurality of urethra suction ports 133 with a comparatively small aperture are provided as in the present embodiment, a wide area of the urethral wall can be fixed by suction onto the urethral-insertion device 100 while maintaining a suction force.
When the urethral-insertion device 100 is pushed in toward the inside of a living body (toward the distal side of the shaft 120) in a condition in which the urethral wall is fixed by suction onto the urethra suction ports 133 and the bladder wall is fixed by suction onto the bladder suction port 134, the urethra 1100 and the bladder 1200 are pushed in toward the inside of the body attendant on this, and the bladder 1200 can be shifted to such a position as not to overlap with a puncture route of a puncture needle described later. Further, when the urethral-insertion device 100 is moved toward the vagina side, the position of the bladder 1200 is moved accordingly, whereby the bladder 1200 can be shifted to such a position as not to overlap with the puncture route of the puncture needle. Accordingly, a puncture route for the puncture needle can be relatively secured in a large range, so that puncturing by the puncture needle can be performed relatively accurately and safely.
Note that the number of the urethra suction ports 133 is not particularly limited; for example, only one urethra suction port 133 may be provided. In addition, the layout of the urethra suction ports 133 is not specifically restricted; for example, the urethra suction ports 133 may be formed in only part of the circumferential range of the urethral-insertion device 100 or over the whole range of the circumference.
Now, the first to third steps will be described in detail below, referring to
As illustrated in
As shown in
In accordance with an exemplary embodiment, for example, with the bladder upper wall 1210 fixed by suction onto the bladder suction port 134, the bladder upper wall 1210 is brought closer to the bladder suction port 134, whereby the shape of the bladder 1200 (the position of the bladder upper wall 1210) is changed. Further, with the urethral-insertion device 100 moved in the direction of the vagina 1300 (in the downward direction) or with the urethral-insertion device 100 moved in the inserting direction (toward the distal side), the position of the bladder 1200 is changed. By thus changing the shape of the bladder 1200 or changing the position of the bladder 1200, the bladder 1200 can be spaced away from the puncture route of the puncture needle, so that mispuncture of the bladder 1200 by the puncture needle can be prevented from occurring.
Particularly, if the urethral-insertion device 100 (the shaft 120) is rigid over the whole length thereof, it can help ensure that when the position or the shape of the bladder 1200 is changed by the urethral-insertion device 100, the urethral-insertion device 100 will not be deformed by a pressure exerted from the biological tissue, and the bladder 1200 can be easily shifted to such a position as not to overlap with the puncture route of the puncture needle.
Note that the broken lines in
In the third step, first, the vagina upper wall is incised with a surgical knife or the like, to form an incised part 1310, as depicted in
Note that the method for placing the sling indwelling in a living body is not restricted to the above-mentioned. The method may include: a first step of inserting the urethral-insertion device into the urethra; a second step of attracting by suction the bladder wall by the bladder suction port provided in the urethral-insertion device; a third step of moving the bladder from its original position with the bladder wall attracted by suction; and a fourth step of placing the sling indwelling in a biological tissue between the urethra and the vagina.
Specifically, the bladder can be spaced away from the puncture route of the puncture needle by moving the bladder from its original position while utilizing the urethral-insertion device.
In addition, for example, a method may be adopted in which the vagina upper wall of the vagina is incised and the sling is set indwelling in the living body through the incision.
In accordance with an exemplary embodiment, the puncture route of the puncture needle may extend from an inguinal region (groin) on one side to an inguinal region on the other side. In this case, the puncture needle is percutaneously inserted from the inguinal region on one side, to form a puncture route, which extends through an obturator foramen on one side, then through a biological tissue between the urethra and the vagina and through an obturator foramen on the other side to reach the inguinal region on the other side. Therefore, an incised part 1310 is not formed in the vagina wall and, accordingly, the invasion to the living body can be minimized.
After the sling 9 is set indwelling, the suction through the urethra suction ports 133 and the bladder suction port 134 is stopped, the urethral-insertion device 100 is withdrawn from the living body, and the incised part 1310 is sutured, to finish the procedure.
Referring to this drawing, the second embodiment of the urethral-insertion device 100 will now be described below. The following description focuses on differences of the second embodiment from the first embodiment described above, and the description of the same items as above will be omitted.
This second embodiment is the same as the first embodiment except for a difference in the configuration of the shaft 120.
A urethral-insertion device 100 according to the second embodiment shown in
In addition, the urethral-insertion device 100 in the second embodiment depicted in
Referring to this drawing, the third embodiment of the urethral-insertion device 100 will now be described below. The following description focuses on differences of the third embodiment from the embodiments described above, and the description of the same items as above will be omitted.
This third embodiment is the same as the second embodiment above except for a difference in the configuration of the shaft 120.
A urethral-insertion device 100 according to the third embodiment shown in
Referring to this drawing, the fourth embodiment of the urethral-insertion device 100 will now be described below. The following description focuses on differences of the fourth embodiment from the embodiments described above, and the description of the same items as above will be omitted.
The fourth embodiment is the same as the first embodiment above except for a difference in the configuration of the shaft 120.
A urethral-insertion device 100 according to the fourth embodiment shown in
The balloon 140 is connected to a balloon port (not shown) on a proximal side of the urethral-insertion device 100 through a lumen of the shaft 120.
A balloon expanding device such as a syringe can be connected to the balloon port. When a working fluid (a liquid such as physiological salt solution or a gas or the like) is supplied from the balloon expanding device into the balloon 140, the balloon 140 is expanded. Conversely, when the working fluid is drawn out of the balloon 140 by the balloon expanding device, the balloon 140 is contracted. With the balloon 140 expanded after inserted into a bladder 1200 to be thereby pressed against a bladder neck, the urethral-insertion device 100 can be disposed into an appropriate position.
Referring to this drawing, the fifth embodiment of the urethral-insertion device 100 will now be described below. The following description focuses on differences of the fifth embodiment from the embodiments described above, and the description of the same items as above will be omitted.
This fifth embodiment is the same as the first embodiment above except for a difference in the configuration of the shaft 120.
A urethral-insertion device 100 according to the fifth embodiment shown in
In addition, after the urethral-insertion device 100 is inserted in the urethra 1100, the stylet 200 is inserted into the through-hole 150, and the stylet 200 is protruded from the distal opening of the through-hole 150. Next, a depth wall of a bladder 1200 may be pushed in by the stylet 200, thereby moving the position of the bladder 1200. By this, the position of the bladder 1200 can be spaced away from a puncture route of a puncture needle. Besides, with the depth wall of the bladder 1200 pushed, a bladder upper wall 1210 is moved toward the vagina side. Therefore, the distance between the bladder suction port 134 and the bladder upper wall 1210 is shortened, so that the bladder upper wall 1210 can be more easily attracted and fixed by suction.
Note that the material constituting the stylet 200 is not particularly limited. Examples of the usable material include various metallic materials such as stainless steel, aluminum or aluminum alloys, titanium or titanium alloys, etc. and various resin materials.
Referring to these drawings, the sixth embodiment of the urethral-insertion device 100 will now be described below. The following description focuses on differences of the sixth embodiment from the embodiments described above, and the description of the same items as above will be omitted.
The sixth embodiment is the same as the first embodiment except for having a pushing part 160.
A urethral-insertion device 100 according to the sixth embodiment shown in
In accordance with an exemplary embodiment, the slide pipe 161 is pipe-like in shape, is disposed to cover an outer periphery of the shaft 120, and is slidable forward and backward on the outer peripheral surface of the shaft 120 along the outer peripheral surface of the shaft 120. Note that the slide pipe 161 can be provided with a slit for preventing the slide pipe 161 from closing urethra suction ports 133 when the slide pipe 161 is slid. The operation part 164 is located on a distal side of a hub 110, and is connected to the slide pipe 161. Therefore, the slide pipe 161 is slid forward and backward on the outer peripheral surface of the shaft 120 by the sliding operation of the operation part 164. In addition, the hub 110 may have a function as a stopper for stopping the sliding operation of the operation part 164.
In accordance with an exemplary embodiment, the extension wires 162 and 163 are each composed of wire, and are disposed with distal portions of the extension wires 162 and 163 fixed to the distal side of the shaft 120 and with proximal portions of the extension wires 162 and 163 fixed to the distal side of the slide pipe 161. Besides, the extension wires 162 and 163 are disposed opposite to each other, with the shaft 120 between the extension wires 162, 163. With the slide pipe 161 slid along the shaft 120 by a sliding operation of the operation part 164, the distance between the distal end of the slide pipe 161 and the distal end of the shaft 120 is changed. By this, the distance between distal end portions and proximal end portions of the extension wires 162 and 163 can be changed, so that the shapes of the extension wires 162 and 163 are deformed.
Specifically, when the operation part 164 is operated for sliding in an inserting direction, starting from a condition in which the extension wires 162 and 163 are rectilinear in shape as shown in
After the extension wires 162 and 163 are inserted into a bladder 1200, left and right walls of the bladder 1200 can be pushed by deforming the extension wires 162 and 163 to protrude in the radially outward directions of the shaft 120. With the left and right walls of the bladder 1200 thus pushed, the bladder 1200 is broadened in the lateral direction, and a bladder upper wall 1210 is moved in a downward direction (in a direction toward a vagina) accordingly, so that the distance between the bladder upper wall 1210 and a bladder suction port 134 is shortened. Consequently, the bladder upper wall 1210 can be easily attracted by suction.
Referring to these drawings, the seventh embodiment of the urethral-insertion device 100 will now be described below. The following description focuses on differences of the seventh embodiment from the embodiments described above, and the description of the same items as above will be omitted.
This seventh embodiment is the same as the second embodiment above except for having a vaginal-insertion member 170 connected to the urethral-insertion device 100.
A urethral-insertion device 100 shown in
The materials constituting the vaginal-insertion member 170 and the connection part 180 are not particularly limited. Various metallic materials such as stainless steel, aluminum or aluminum alloys, titanium or titanium alloys, etc. and various resin materials can be used for the vaginal-insertion member 170 and the connection part 180, like for the shaft 120.
The vaginal-insertion member 170 has guiding grooves 171 for guiding a puncture needle for puncturing a biological tissue. The guiding grooves 171 are present on both sides (left and right sides) of the vaginal-insertion member 170. In top plan view in
Referring to these drawings, the eighth embodiment of the urethral-insertion device 100 will now be described below. The following description focuses on differences of the eighth embodiment from the embodiments described above, and the description of the same items as above will be omitted.
This eighth embodiment is the same as the seventh embodiment except for a difference in the configuration of the vaginal-insertion member 170 connected to the urethral-insertion device 100.
As shown in
The guiding grooves 171 are each present in the side wall parts 173, and are each present in an inclined form to extend gradually upward from a proximal-side opening thereof located on the proximal side of the side wall part 173 toward a distal-side opening thereof located on the distal side of the side wall part 173. The support part 172 and the pair of side wall parts 173 of the vaginal-insertion member 170 have a roughly U-shaped overall sectional form such as to surround the shaft 120. With the urethral-insertion device 100 thus provided with the vaginal-insertion member 170, the puncture needle can puncture a biological tissue while avoiding a urethra 1100.
Note that the vaginal-insertion member 170 may be so configured that it can be attached to and detached from the shaft 120 through a connection part 180. In this case, the vaginal-insertion member 170 can be attached to the connection part 180 after insertion of the shaft 120 into the urethra 1100. Accordingly, the urethral-insertion device 100 can be disposed at an appropriate position relatively easily.
Referring to these drawings, the ninth embodiment of the urethral-insertion device 100 will now be described below. The following description focuses on differences of the ninth embodiment from the embodiments described above, and the description of the same items as above will be omitted.
This ninth embodiment is the same as the eighth embodiment except for a difference in the configuration of the vaginal-insertion member 170 connected to the urethral-insertion device 100.
As shown in
Referring to these drawings, the tenth embodiment of the urethral-insertion device 100 will now be described below. The following description focuses on differences of the tenth embodiment from the embodiments described above, and the description of the same items as above will be omitted.
This tenth embodiment is the same as the sixth embodiment above except for a difference in the configuration of the pushing part 160 provided in the urethral-insertion device 100 and a difference in the position of a suction surface of the bladder suction port 134.
In accordance with an exemplary embodiment, the pushing part 160 shown in
The extension plates 165 and 166 are each composed of a plate-shaped body, and are disposed with distal end portions of the extension plates 165 and 166 fixed to a distal end portion of the shaft 120 and with proximal end portions of the extension plates 165 and 166 fixed to a distal end portion of the slide pipe 161. In addition, the extension plates 165 and 166 are disposed opposite to each other, with the shaft 120 between the extension plates 165, 166. With the slide pipe 161 slid along the shaft 120 by the sliding operation of the operation part 164, the distance between the distal end of the slide pipe 161 and the distal end of the shaft 120 is changed. By this, the distance between the distal end portions and the proximal end portions of the extension plates 165 and 166 is changed, so that the shape of the extension plates 165 and 166 is deformed.
As shown in
In addition, as shown in
Referring to these drawings, the eleventh embodiment of the urethral-insertion device 100 will now be described below. The following description focuses on differences of the eleventh embodiment from the embodiments described above, and the description of the same items as above will be omitted.
This eleventh embodiment is the same as the tenth embodiment except for a difference in the configuration of the pushing part 160 provided in the urethral-insertion device 100.
The pushing part 160 shown in
The extension wire 168 is composed of wire, and is disposed with a distal end portion of the extension wire 168 fixed to a distal end portion of a shaft 120 and with a proximal end portion of the extension wire 168 fixed to a distal end portion of a slide pipe 161. With the slide pipe 161 slid along the shaft 120 by an operation for sliding of an operation part 164, the distance between the distal end of the slide pipe 161 and the distal end of the shaft 120 is changed. By this, the distance between the distal end portion and the proximal end portion of the extension wire 168 is changed, so that the extension wire 168 is deformed to protrude in the radially outward direction.
In the above embodiments, description has been made of the case where the urethral-insertion device is applied to a device for use in embedding in a living body a sling embeddable for treatment of female urinary incontinence. The use of the urethral-insertion device, however, is not limited to the described one.
For example, the target of the application of the present disclosure includes excretory disorders attendant on the weakening of the pelvic floor muscle group (urinary urgency, frequent urination, urinary incontinence, fecal incontinence, urinary retention, strangury or the like), and pelvic floor disorders including pelvic organ prolapse, vesicovaginal fistula, urethrovaginal fistula, pelvic pain or the like. In the pelvic organ prolapse, there are included disorders of cystocele, enterocele, rectocele, hysterocele and the like. Alternatively, there are included such disorders as anterior vaginal prolapse, posterior vaginal prolapse, vaginal apical prolapse, vaginal vault prolapse and the like in which the naming method thereof is based on the prolapsed vaginal-wall part.
Also, overactive tissues include bladder, vagina, uterus, bowel and the like. Less active tissues include bones, muscles, fascias, ligaments and the like. In particular, in the case of pelvic floor disorders, the less active tissues include an obturator fascia, a coccygeus fascia, a cardinal ligament, an uterosacral ligament, a sacrospinous ligament and the like.
For the procedure for interlocking an overactive tissue in the pelvic floor disorder with the less active tissue, there are included retropubic sling surgery, transobturator sling surgery, transobturator tape (TOT), tension-free vaginal mesh (TVM), uterosacral ligament suspension (USLS), sacrospinous ligament fixation (SSLF), iliococcygeus fascia fixation surgery, coccygeus fascia fixation surgery, and the like.
The detailed description above describes a urethral-insertion device. The disclosure is not limited, however, to the precise embodiments and variations described. Various changes, modifications and equivalents can be effected by one skilled in the art without departing from the spirit and scope of the disclosure as defined in the accompanying claims. It is expressly intended that all such changes, modifications and equivalents which fall within the scope of the claims are embraced by the claims.
This application contains subject matter disclosed in U.S. Application No. 62/105,344 filed on Jan. 20, 2015, which is incorporated herein by reference in its entirety.
Number | Date | Country | |
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62105344 | Jan 2015 | US |