Implantable device for surgical treatment of urinary incontinence

Abstract

FIELD: medical devices.SUBSTANCE: implantable device for the surgical treatment of urinary incontinence is made in the form of a section of a form-stable knitted tape made of biocompatible monofilaments, which is knitted in one piece across the width and is formed by longitudinal loop columns connected by transverse drawstrings and lateral smooth, rounded and closed loops limiting the lateral edges of the tape. The skeletons of the loops of the internal columns are formed by two threads. The outer loop columns consist of alternating loops, the skeletons of which are formed by two threads and one thread through the use of two systems of monofilaments with knitting parameters: the first system – 1 / 0, 4 / 5, the second system – 0 / 1, 1 / 0 with a rapport equal to 2. A section of shape-stable knitted tape is provided with four adjustment loops, the ends of one of which are connected to one end of the section of shape-stable knitted tape, the ends of the second to the other end of the section of shape-stable knitted tape, and the third and fourth adjustment loops are passed through the central part of the section of shape-stable knitted tape. The third adjustment loop is located at a distance of 25–30 mm from the middle of the central part of the section of shape-stable knitted tape in one direction, and the second one is at the same distance from its middle in the opposite direction. The third and fourth adjustment loops are passed through the central part so that their ends are at the same level relative to each other.EFFECT: increasing the efficiency of correcting the tension of the shape-stable knitted tape in the early postoperative period.3 cl, 1 dwg

Description

[0001] The invention relates to the field of medicine, namely urology and gynecology, and can be used in the surgical treatment of stress urinary incontinence.

[0002] A TOA adjustable device (AMI, Austria) is known for the surgical treatment of urinary incontinence. It is a tape pre-cut from a fabric knitted from non-absorbable bioinert polypropylene monofilaments and placed in a polyethylene cover. The said device has four groups of adjustment loops made of non-absorbable polypropylene monofilament: three loops at each end of the tape and two loops in the central part of the tape at an equal distance from its middle on both sides of it, and the end of each adjustment loop in the central part of the tape is connected to an atraumatic needle placed in a protective cover [Romero et al., 2009. Transobturator adjustable tape (TOA) permits to correct the tension applied in stress incontinence surgery postoperatively. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jul;20(7):797-805. Epub 2009 Apr 24].

[0003] The disadvantages of this device are the traumatic edge of the tape, which necessitates the use of removable protective covers, and the need for additional downward adjustment loops through the vaginal mucosa, which complicates its design and increases the time of the operation.

[0004] A known implantable device for the surgical treatment of urinary incontinence. The device is made of a length of dimensionally stable knitted tape made of biocompatible monofilaments, including polypropylene and / or polyvinylidene fluoride, with a diameter of 0.1 mm. The dimensionally stable knitted tape is seamlessly knitted across its width and formed by five or six longitudinal loop columns connected by transverse drawstrings and smooth, rounded, closed lateral loops delimiting the lateral edges of the tape. The loop skeletons of the inner columns are formed by two threads. The outer loop columns consist of alternating loops, the skeletons of which are formed by two threads and one thread through the use of two systems of monofilaments with knitting parameters: the first system - 1 / 0, 4 / 5, the second system - 0 / 1, 1 / 0 with a rapport equal to 2 [Patent RU 2297808, published 2007].

[0005] The description of the invention states that the weave, resistant to stretching, due to the structure of the longitudinal loop columns and the lateral edges, consisting of smooth, rounded closed loops, provide the claimed technical solution with a stable, non-deformable structure under stretching, making it possible to correct the degree of tension of the endoprosthesis tape in the early postoperative period.

[0006] A disadvantage of the above device is the lack of elements that allow for precise adjustment of the tension of the form-stable knitted tape segment during the postoperative period. Tension correction is only possible with the use of additional instruments, such as urethral bougies or Hegar dilators. These instruments are inserted into the urethra and applied caudal traction, shifting the form-stable knitted tape segment. However, it is difficult to determine the distance by which the form-stable knitted tape segment is shifted, and there is no way to increase the tension of the form-stable knitted tape segment.

[0007] The disadvantages of the described technique include the high level of trauma during adjustment and poorly controlled amplitude of displacement of the knitted tape segment. These disadvantages result in lower treatment efficacy early in the postoperative period, as well as a higher incidence of urinary retention and urinary dysfunction associated with excessive tension on the knitted tape segment.

[0008] The presence of adjustment loops is necessary to achieve optimal, customized tension on the dimensionally stable knitted tape. Their placement, 25-30 mm from the center, ensures that when using the device, the attachment points of the adjustment threads are located in the vaginal vaults as far away as possible from the surgical wound, reducing the risk of damage to the wound during adjustment and, consequently, reducing the risk of mesh implant protrusion into the vaginal lumen in the late postoperative period.

[0009] The closest device to the claimed device is the UroSling endoprosthesis. It is a tape 15 cm long and 1.1 cm wide, made of monofilament polypropylene and polyvinylidene fluoride threads. The prosthesis has low material consumption (60 g / m2) and stretchability, is highly bioinert and resistant to infection, and the edges of the implant are designed as closed loops. In the central part of the endoprosthesis, there are two adjustment loops made of polypropylene monofilament, located at a distance of 15 mm from the midline. Traction by the adjustment loops leads to a weakening of the sling tension, while pulling by the ends of the endoprosthesis increases it. The ends of the tape and the adjustment loops on the corresponding sides have the same color markings to determine the direction of traction [Shkarupa D.D. Adjustable transobturator sling as a first-line surgical treatment for stress urinary incontinence in women. Experimental and Clinical Urology. Issue No. 2, 2017 - p.84-91].

[0010] The disadvantages of the closest analogue include potential risks associated with its use, due to the fact that the attachment points of the adjustment loops are located close to the surgical wound. This can lead to damage to the surgical wound when the tension on the device is released.

[0011] The technical problem is the need to develop an effective implantable device for the surgical treatment of urinary incontinence, free from the above-mentioned disadvantages.

[0012] The technical result is to increase the efficiency of correcting the degree of tension of the shape-stable knitted tape in the early postoperative period and, as a consequence, to reduce the number of cases of persistent urine loss and the frequency of development of urinary retention and urination disorders while simultaneously minimizing the risks of injury to the surgical wound during the adjustment process.

[0013] The technical result is achieved in that in an implantable device for the surgical treatment of urinary incontinence, made in the form of a section of a shape-stable knitted tape made of biocompatible monofilaments, the shape-stable knitted tape is solidly knitted in width and is formed by at least five longitudinal loop columns connected by transverse broaches and lateral smooth, rounded, closed loops limiting the lateral edges of the tape, wherein the skeletons of the loops of the internal columns are formed by two threads, and the outer loop columns consist of loops alternating through one, the skeletons of which are formed by two threads and one thread due to the use of two systems of monofilaments with knitting parameters: the first system - 1 / 0, 4 / 5, the second system - 0 / 1, 1 / 0 with a rapport equal to 2, wherein the device is provided with four adjustment loops, the ends of one of which are connected to one of the ends a piece of dimensionally stable knitted tape,and the ends of the second one are connected to the other end of the section of the shape-stable knitted tape, and the other two adjustment loops are passed through the central part of the section of the shape-stable knitted tape; according to the invention, one of the adjustment loops is located at a distance of 25-30 mm from its middle in one direction, and the second one is at the same distance from its middle in the opposite direction.

[0014] The presence of adjustment loops is necessary to achieve optimal, customized tension on the dimensionally stable knitted tape. Their placement, 25-30 mm from the center, ensures that when using the device, the attachment points of the adjustment threads are located in the vaginal vaults as far away as possible from the surgical wound, reducing the risk of damage to the wound during adjustment and, consequently, reducing the risk of mesh implant protrusion into the vaginal lumen in the late postoperative period.

[0015] In addition, during traction on the adjustment loops, the movement of the specified section of shape-stable knitted tape occurs along the course of its installation with minimal trauma to the surrounding tissues.

[0016] The ends of the adjustment loops are connected to the ends of the section of shape-stable knitted tape using heat-shrinkable polypropylene tubes of different colors, similar heat-shrinkable tubes are installed at the ends of the adjustment loops passed through the central part of the section of shape-stable knitted tape, while the color of the heat-shrinkable tubes installed on the same side from the center of the above-mentioned section matches.

[0017] The production of heat-shrinkable tubes, installed on the same side from the center of the specified section of shape-stable knitted tape, in one color allows you to determine the right and left adjustment loops in the postoperative period, select the desired direction of traction, and, if necessary, shift only one side of the tape section.

[0018] The adjustment loops located at the ends of the section of shape-stable knitted tape are made of non-absorbable braided Lavsan thread with a fluoropolymer coating, USP 2, EP 5, and the adjustment loops passed through the central part of the above section are made of polypropylene monofilament USP 2, EP 5.

[0019] The production of adjustment loops placed at the ends of the said section of shape-stable knitted tape from non-absorbable braided lavsan thread with a fluoropolymer coating, and adjustment loops passed through the central part of the above-mentioned section from polypropylene monofilament eliminates contamination of the section of shape-stable knitted tape with vaginal flora, due to the absence of wicking properties in the said threads and their high bioinertness.

[0020] The set of features of the invention is new and allows for precise adjustment of the tension of a section of shape-stable knitted tape, as well as increasing the efficiency of correcting the degree of its tension in the early postoperative period without additional instruments, which, in turn, reduces the risk of developing urinary retention and urination disorders in the early postoperative period.

[0021] The claimed invention is illustrated by a drawing, which shows the claimed device in general form. The following reference numbers are used in the drawing:

[0022] 1 - adjustment loops connected to the ends of a piece of shape-stable knitted tape;

[0023] 2 - a piece of shape-stable knitted tape;

[0024] 3 - the end of a piece of shape-stable knitted tape;

[0025] 4 - the central part of a piece of shape-stable knitted tape;

[0026] 5 - adjustment loops passed through the central part of a piece of shape-stable knitted tape;

[0027] 6 - heat shrinkable polypropylene tubes.

[0028] An implantable device for the surgical treatment of urinary incontinence, made in the form of a section of a shape-stable knitted tape (2), made of biocompatible monofilaments, the shape-stable knitted tape is solid knitted in width and is formed by five or six longitudinal loop columns connected by transverse broaches and lateral smooth, rounded, closed loops limiting the lateral edges of the tape, and the skeletons of the loops of the inner columns are formed by two threads, and the outer loop columns consist of alternating loops, the skeletons of which are formed by two threads and one thread due to the use of two systems of monofilaments with knitting parameters: the first system - 1 / 0, 4 / 5, the second system - 0 / 1, 1 / 0 with a rapport equal to 2. The device is equipped with four adjustment loops (1), the ends of one of which are connected to one of the ends a piece of shape-stable knitted tape (3), and the ends of the second one are connected to the other end of the piece of shape-stable knitted tape (2),and two other adjustment loops (1) are passed through the central part of the section of shape-stable knitted tape (4), one of which is at a distance of 25-30 mm from its middle in one direction, and the second - at the same distance from its middle in the opposite direction, and the adjustment loops (1) are passed so that the ends of the loops are at the same level relative to each other; the connection of the ends of the adjustment loops with the ends of the section of shape-stable knitted tape (3) is made with the help of heat-shrinkable polypropylene tubes of different colors, similar heat-shrinkable tubes are installed on the ends of the adjustment loops passed through the central part of the section of shape-stable knitted tape, and the color of the heat-shrinkable tubes installed on the same side from the center of the above-mentioned section matches; the adjustment loops placed at the ends of the section of shape-stable knitted tape,are made of non-absorbable braided lavsan thread with a fluoropolymer coating, USP 2, EP 5, and the adjustment loops passed through the central part of the above-mentioned section are made of polypropylene monofilament USP 2, EP 5.,

[0029] The implantable device for surgical treatment of urinary incontinence works as follows.

[0030] One of the adjustment loops (1), connected to the end of a section of dimensionally stable knitted tape, is attached to a surgical instrument for the treatment of urinary incontinence, such as that described in patent RU63206 (2006) and consisting of a curved element with a pointed tip attached to a handle. The adjustment loop is passed through the endoprosthesis insertion hole made in the curved portion of the surgical instrument and placed over its pointed tip.

[0031] Using Metzenbaum curved delicate scissors, channels are formed bilaterally in the paraurethral space towards the posterior surface of the inferior rami of the pubic bones at an angle of 90 degrees. Using the above-mentioned surgical instrument for the treatment of urinary incontinence, a piece of shape-stable knitted tape (2) is passed along the formed channels through the obturator openings using the "inside-out" technique. The end of the piece of shape-stable knitted tape (3) is brought out through a skin incision in the projection of the superomedial edge of the obturator foramen, at a distance of 1.5 cm below the tendon of m. adductor longus. A similar procedure is repeated on the other side, passing the piece of shape-stable knitted tape (2) bilaterally. By traction on the ends of the piece of shape-stable knitted tape (3), the central part of the piece of shape-stable knitted tape (4) is placed under the urethra.A piece of shape-stable knitted tape (2) is positioned in a free position by placing the closed jaws of Metzenbaum scissors between the said piece of tape (2) and the urethra. The anterior vaginal wall is sutured by passing adjustment loops, passed through the central part of the piece of shape-stable knitted tape (5), between the sutures in the central part of the incision. Additionally, a single reductive suture is applied between the adjustment loops passed through the central part of the piece of shape-stable knitted tape (5) to the edges of the anterior vaginal wall defect, after which the adjustment loops passed through the central part of the piece of shape-stable knitted tape (5) are placed into the vagina. The ends of the piece of shape-stable knitted tape (3) and the adjustment loops (1) connected to them are placed under an aseptic dressing.

[0032] On the next day after the operation, if urine loss persists, gentle traction is performed on the adjustment loops connected to the ends of the section of shape-stable knitted tape (1) in the cranial direction along the location of the section of shape-stable knitted tape (2) under the control of a cough test until complete urine retention.

[0033] In case of urinary retention or obstructive urination, on the day following the surgery, traction is applied alternately to the adjustment loops passed through the central part of the shape-stable knitted tape segment (5) caudally and in the opposite direction from the end of the shape-stable knitted tape segment (3) with a heat-shrinkable polypropylene tube (6) of the same color. Upon achieving the desired result, the ends of the shape-stable knitted tape segment (3) and the adjustment loops (1) connected to them are cut off, and the adjustment loops passed through the central part of the shape-stable knitted tape segment (5) are cut and pulled out of the wound.

[0034] The claimed invention is explained by examples.

[0035] Example 1.

[0036] Patient A. Diagnosis: stress urinary incontinence.

[0037] As a result of diagnostic measures, a decision was made to perform surgical treatment using the claimed device.

[0038] One of the adjustment loops, connected to the end of a form-stable knitted tape, was attached to a surgical instrument. This instrument consisted of a curved element with a pointed tip attached to a handle. The adjustment loop was passed through the endoprosthesis insertion hole made in the curved part of the instrument and placed over its pointed tip.

[0039] Bilaterally, using curved Metzenbaum scissors, channels were created in the paraurethral space at a 90-degree angle toward the posterior surface of the inferior pubic rami. Next, using the aforementioned instrument, a piece of form-stable knitted tape was passed through the formed channels through the obturator foramina using the "inside-out" technique. The end of the tape was brought out through a skin incision in the projection of the superomedial edge of the obturator foramen, 1.5 cm below the adductor longus tendon. A similar procedure was performed on the opposite side.

[0040] Using traction on the ends of the tape, its central portion was positioned under the urethra. The sling was freed by placing the closed jaws of Metzenbaum scissors between the tape and the urethra.

[0041] The anterior vaginal wall was closed by passing adjustment loops through the central portion of the tape between the sutures. A single reductive suture was placed between these loops along the edges of the anterior vaginal wall defect, after which the loops were inserted into the vaginal lumen. The ends of the tape and the attached adjustment loops were placed under an aseptic dressing.

[0042] Postoperative period:

[0043] Minor urinary incontinence persisted. On the day following surgery, gentle traction was applied cranially using the adjustment loops connected to the ends of the tape. Traction was performed under the guidance of a cough test until complete urinary continence was achieved.

[0044] The subsequent postoperative period was without complications.

[0045] Example 2.

[0046] Patient B. Diagnosis: stress urinary incontinence.

[0047] As a result of diagnostic measures, a decision was made to perform surgical treatment using the claimed device.

[0048] One of the adjustment loops, connected to the end of a form-stable knitted tape, was attached to a surgical instrument. This instrument consisted of a curved element with a pointed tip attached to a handle. The adjustment loop was passed through the endoprosthesis insertion hole made in the curved portion of the instrument and placed over its pointed tip.

[0049] Bilaterally, using curved Metzenbaum scissors, channels were created in the paraurethral space at a 90-degree angle toward the posterior surface of the inferior pubic rami. Next, using the aforementioned instrument, a piece of form-stable knitted tape was passed through the formed channels through the obturator foramina using the "inside-out" technique. The end of the tape was brought out through a skin incision in the projection of the superomedial edge of the obturator foramen, 1.5 cm below the adductor longus tendon. A similar procedure was performed on the opposite side.

[0050] Using traction on the ends of the tape, its central portion was positioned under the urethra. The sling was freed by placing the closed jaws of Metzenbaum scissors between the tape and the urethra.

[0051] The anterior vaginal wall was closed by passing adjustment loops through the central portion of the tape between the sutures. A single reductive suture was placed between these loops along the edges of the anterior vaginal wall defect, after which the loops were inserted into the vaginal lumen. The ends of the tape and the attached adjustment loops were placed under an aseptic dressing.

[0052] During the postoperative period, obstructive urination was observed. During the same period, traction was applied alternately to the adjustment loops inserted through the central portion of the tape, in a caudal direction. After satisfactory urination was achieved, the ends of the tape and the attached adjustment loops were cut off. The adjustment loops inserted through the central portion of the tape were dissected and removed from the wound.

[0053] The subsequent postoperative period was without complications.

Claims

1. An implantable device for the surgical treatment of urinary incontinence, made in the form of a section of a shape-stable knitted tape made of biocompatible monofilaments, which is seamlessly knitted in width and formed by longitudinal loop columns connected by transverse drawstrings and lateral smooth, rounded and closed loops limiting the lateral edges of the tape, the skeletons of the loops of the inner columns are formed by two threads, and the outer loop columns consist of loops alternating through one, the skeletons of which are formed by two threads and one thread due to the use of two systems of monofilaments with knitting parameters: the first system - 1 / 0, 4 / 5, the second system - 0 / 1, 1 / 0 with a rapport equal to 2, the section of shape-stable knitted tape is equipped with four adjustment loops, the ends of one of which are connected to one of the ends of the section of shape-stable knitted tape, the ends of the second - to the other end a piece of dimensionally stable knitted tape,and the third and fourth adjustment loops are passed through the central part of the section of shape-stable knitted tape, characterized in that the third adjustment loop is located at a distance from the middle of the central part of the section of shape-stable knitted tape by 25-30 mm in one direction, and the second - at the same distance from its middle in the opposite direction, while the third and fourth adjustment loops are passed through the central part so that their ends are at the same level relative to each other.

2. The device according to paragraph 1, characterized in that polypropylene biocompatible monofilaments with a diameter of 0.1 mm are used.

3. The device according to paragraph 1, characterized in that biocompatible polyvinylidene fluoride monofilaments with a diameter of 0.1 mm are used.

Images