RU2825064C1 - Combined sling prosthesis for treating stress urinary incontinence in females - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medical equipment. Combined sling prosthesis for treating stress urinary incontinence in females comprises a polypropylene mesh for sling surgery and an allograft sewn in the middle. Allograft is an Alloplant allograft produced from fascia lata. Polypropylene mesh has dimensions of 300×11 mm and cut in the middle for hemming the Alloplant allograft of 100×11 mm. Anastomosis area of the polypropylene mesh and the Alloplant allograft is 20 mm on each side, and the total length of prosthesis is 360 mm. Prosthesis is configured to adjust its tension to achieve pressure on the urethra for urine retention in a cough test.

EFFECT: improved results of surgical treatment of stress urinary incontinence.

1 cl, 1 dwg, 1 ex

Description

The invention relates to medicine, in particular to urology, and can be used for surgical treatment of stress urinary incontinence in women.

One of the most common urological diseases in women is urinary incontinence (UI) - a condition that has an extremely negative impact on the quality of life of patients. Stress urinary incontinence (SUI) is a condition characterized by involuntary loss of urine resulting from increased intra-abdominal pressure during sneezing, coughing and physical exertion [Haylen 2010]. This condition occurs due to dislocation and weakening of the ligamentous apparatus of the unchanged urethra and urethrovesical segment, which refers to anatomical urinary incontinence, and a disease associated with changes in the urethra itself and the sphincter apparatus, leading to dysfunction of the sphincter apparatus. Estimates of the prevalence of UI in the female population range from 10% to 40% [Capobianco G, Madonia M, Morelli S, Dessole F, De Vita D, Cherchi PL, Dessole S. Management of female stress urinary incontinence: A care pathway and update. Maturitas. 2018 Mar; 109:32-38. doi: 10.1016/j.maturitas.2017.12.008. Epub 2017 Dec 9. PMID: 29452779.].

When considering the treatment of urinary incontinence in women, many surgical treatment methods were proposed. In 1961, J. Burch proposed performing retropubic colposuspension, in which periurethral tissues were fixed to Cooper's ligaments. This operation was considered the "gold standard" in the treatment of urinary incontinence in women for many decades. The main disadvantages of this method are: high invasiveness, duration (at least 60-90 minutes), the need for anesthesia with artificial ventilation of the lungs, and a pronounced dependence of the results on the qualifications of the surgeon. With the advent of operations to install a synthetic midurethral sling, Burch's colposuspension lost its positions.

Steckel is considered the founder of sling operations in Europe, and E. McGuire in the USA. They proposed loop plastic surgery with the formation of a flap from the fascia of the rectus abdominis muscle. In 1978, E. McGuire and B. Lytton proposed the use of an isolated fascial flap, which was installed under the urethra in the form of a loop using a combined abdominal-vaginal approach.

Currently, the "gold standard" in surgical treatment of women with stress urinary incontinence is the TVT (Tension-free Vaginal Tape) operation. The technique of sling surgery using a free synthetic loop was developed by the Swedish professor U. Ulmsten in 1995. According to this technique, a synthetic loop (tape) is passed from the vagina to the suprapubic region and left in the tissues without additional fixation. The loop, located in this way, replaces the damaged ligamentous apparatus, and when intra-abdominal pressure increases, the urethra is pressed against the inextensible loop, which leads to closure of its lumen [Ulmsten U., Henriksson L., Johnson P., Varhos G. An ambulatory surgical procedure under local anesthesia for the treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 1996; 7 (2): 81-5.].

Currently, there are more than 40 different synthetic slings in the world used to treat stress urinary incontinence [“Urinary Incontinence in Women” Methodical Recommendations No. 4. 2017. G.R. Kasyan, M.Yu. Gvozdev, A.G. Konoplyannikov, D.Yu. Pushkar], which indicates the predominance of synthetic suburethral tapes. However, it is noteworthy that more and more reports show complications associated with the implantation of polypropylene (PP) mesh, such as erosion of periurethral tissues, dyspareunia and recurrence of urinary incontinence [N. Mangir, S. Roman, C.R. Chappie, S. MacNeil Complications related to the use of mesh implants in surgical treatment of stress urinary incontinence and pelvic organ prolapse: infection or inflammation?], [C. Clancy, P. Jordan, P.F. Ridgway Polypropylene mesh and systemic side effects in inguinal hernia repair: current evidence Ir. J. Med. Sci., 188 (2019), pp.1349-1356]. This can be explained by the fact that PP mesh triggers an anti-inflammatory macrophage response rather than a macrophagic tissue remodeling response in vivo [A.L. Nolfi, B.N. Brown, R. Liang, S.L. Palcsey, M.J. Bonidie, S.D. Abramowitch, P.A. Moalli Host response to synthetic mesh in women with mesh complications Am. J. Obstet. Gynecol., 215 (206) (2016), pp.el-e8]. Prosthetic mesh material such as non-absorbable polypropylene is characterized by controlled mechanical properties, but can cause adverse reactions due to the non-physiological inert polymer material. Coating such mesh implants with a biocompatible collagen layer can improve the integration of meshes into tissues, as well as reduce the foreign body reaction. [Ackermann M, Wang X, Wang S, Neufurth M, Schroder NS, Isemer FE, Miiller WEG. Collagen-inducing biologization of prosthetic material for hernia repair: Polypropylene meshes coated with polyP/collagen. J Biomed Mater Res In Appl Biomater. 2018 Aug;106(6):2109-2121. doi: 10.1002/jbm.b.34016. Epub 2017 Oct 10. PMID: 29024311.]

Growing recognition of the serious complications associated with non-absorbable polypropylene mesh has led to a resurgence of interest in alternative approaches such as the autologous fascial sling (AFS) [Osman N1, Hillary CJ, Mangera A, Aldamanhoori R, Inman RD, Chappie CR. The Midurethral Fascial "Sling on a String": An Alternative to Midurethral Synthetic Tapes in the Era of Mesh Complications. Eur Urol. 2018 Aug;74(2): 191-196. doi: 10.1016/j.eururo.2018.04.031. Epub 2018 May 24. PMID: 29803585.]. Recently, there has been a resurgence in the use of autologous pubovaginal slings [Schreiner G, Beltran R, Lockwood G, Takacs EB. A timeline of female stress urinary incontinence: how technology defined theory and advanced treatment. Neurourol Urodyn. 2020 Aug;39(6):1862-1867. doi: 10.1002/nau.24407. Epub 2020 Jun 8. PMID: 32511797.]. Autologous biological materials include rectus abdominis muscle, deep fascia of the thigh, pubococcygeus muscle, vaginal wall, aponeurosis, and pyramidal fascia. Despite the effectiveness and durability of this approach, its main disadvantage is the relatively large volume of surgery and trauma. The Consensus Statement of the European Urology Association and the European Gynaecological Association on the Use of Implantable Materials for the Treatment of Pelvic Organ Prolapse and Stress Urinary Incontinence notes the urgent need to search for alternatives to synthetic implants in the form of biological grafts derived from xenograft or allograft [Chappie CR, Cruz F, Deffieux X, Milani AL, Arlandis S, Artibani W, Bauer RM, Burkhard F, Cardozo L, Castro-Diaz D, Cornu JN, Deprest J, Gunnemann A, Gyhagen M, Heesakkers J, Koelbl H, MacNeil S, Naumann G, Roovers JWR, Salvatore S, Sievert KD, Tarcan T, Van der Aa F, Montorsi F, Wirth M, Abdel-Fattah M. Urogynaecological Association on the Use of Implanted Materials for Treating Pelvic Organ Prolapse and Stress Urinary Incontinence. Eur Urol. 2017 Sep;72(3):424-431. doi: 10.1016/j.eururo.2017.03.048. Epub 2017 Apr 14. PMID: 28413126.]

In this regard, it is relevant to develop a domestic hybrid composite mesh prosthesis using a biocompatible material for the surgical treatment of stress urinary incontinence that does not cause an inflammatory reaction of the periurethral tissues associated with the effects of synthetic materials used as slings to date.

The closest analogue of the invention is a prosthesis for the treatment of stress urinary incontinence in women, which is a tape made of a polypropylene mesh prosthesis. According to the description of the authors, a modification is possible in the form of integration of a natural transplant into the central part of the mesh [Patent US No. 7083637 B1, 2006]. In this form, the product is a combination of synthetic and natural materials, with the latter included in the central part of the mesh prosthesis. The approximate width of the tape is about 1 cm, and the length is selected individually for the patient. As the authors indicate, due to such a combination, after installing the tape, the natural material will be along the central part of the tape and located below the urethra, which will eliminate possible problems with erosion in periurethral tissues. The possibility of connecting the materials using stitching, biocompatible glue, cell culturing or other known means is proposed.

The disadvantage of the prototype is the lack of standardized modifications of combined prostheses using natural biocompatible components. Moreover, the possibility of using the above materials is described only in theory, without clinical and experimental confirmation.

The available scientific, medical and patent literature does not contain any information on the use of the Alloplant allograft in combination with a mesh prosthesis for the treatment of stress urinary incontinence and the prevention of complications associated with foreign body reactions and erosions in periurethral tissues.

The objective of the invention is to develop a biocompatible combined prosthesis for the treatment of stress urinary incontinence in women.

The technical result of using the invention is an improvement in the results of surgical treatment of stress urinary incontinence due to the location of the biocompatible section of the combined prosthesis in the most vulnerable zone (contact with the urethral tissue), preventing a reaction to a foreign body and preventing erosion of periurethral tissues. Due to such properties of the allograft as a certain fibroarchitecture, biochemical composition, low antigenicity and high regenerative potential, its complete resorption occurs with the formation of a regenerate within 6-12 months.

The invention is illustrated by a figure showing the proposed combined prosthesis for treating stress urinary incontinence.

The proposed combined prosthesis for treating stress urinary incontinence in women contains a synthetic woven polypropylene mesh 1, 300 mm long and 11 mm wide, intended for a sling operation, with a natural allogeneic graft 2 integrated in the middle, which is an "Alloplant" allograft measuring 100x11 mm, obtained from the broad fascia of the thigh. The total length of the prosthesis is 360 mm. Before the operation, in the operating room, the "Alloplant" allograft is sutured into the middle of a polypropylene mesh previously cut in half for treating stress urinary incontinence, using non-absorbable synthetic monofilament suture material polypropylene 5/0. The anastomosis zone 3 of dissimilar materials is 20 mm on each side (figure). Due to this combination, the trauma to the surrounding tissues of the implanted device is reduced during its installation and in the postoperative period, as well as the absence of an immune response to a foreign body. Symmetrical parts consisting of a PP mesh structure, located in the soft tissues of the small pelvis, provide a fixation mechanism, and the allograft zone ensures the formation of a regenerate. Such a hybrid design of the prosthesis restores the original fascial anatomy of a woman.

The claimed device was used for surgical treatment of stress urinary incontinence in women aged 45 to 63 years. Alloplant is a processed allogeneic biomaterial, completely devoid of antigenic properties, used in tissue regeneration and reconstructive surgery. Many years of experimental and clinical research of the produced Alloplant biomaterials confirms the effectiveness of its use in reparative regeneration processes and the need for alternatives to various donor tissues. Alloplant is widely used in ophthalmology, plastic surgery, dentistry, thoracic surgery, neurosurgery, proctology, orthopedics, traumatology, liver surgery, gynecology, etc.

The Russian Ministry of Health has approved the widespread clinical use of the Alloplant transplant material (Registration Certificate No. 901 dated July 22, 1987). Alloplant is included in the general classification of biological products and is approved for widespread clinical use. Specification No. 42-2-537-93 (Russian Ministry of Health, registration number 056/003230 dated May 17, 1993). Collection of donor cadaveric material is carried out in accordance with the Law of the Russian Federation "On Organ and Tissues Transplantation" No. 4181-1 dated November 22, 1992.

The essence of the invention is explained by the following clinical example. Patient B., 61, was hospitalized with complaints of urine loss when laughing, coughing, sneezing and intense physical exertion. History: two births, the first weighing 3,300 kg, height 51, the second weighing 3,800, height 53 cm. No surgeries were performed during labor. The patient is of normosthenic build, has satisfactory nutrition. She denies surgeries on the pelvic organs. She first noted signs of urinary incontinence about 1 year ago. There is no effect after a conservative course of treatment. The patient underwent the following clinical, laboratory and instrumental studies in the clinic:

24-hour Pad Test: 70 ml (1-2 pads). ISIQ-SF: 11 points.

Ultrasound examination of the bladder - no residual urine

Functional tests:

Valsalva maneuver, or straining test, and cough test with a positive response

Uroflowmetry: maximum flow rate (Qmax) - 39.0 ml/sec, volume (V) - 270 ml.

Without deviation in the general and bacteriological analysis of urine. After all the necessary studies were performed, she underwent surgery: installation of a combined suburethral sling under regional (spinal) anesthesia. To perform the surgery, the claimed prosthesis was used, containing a polypropylene mesh Urosling 300 mm long and 11 mm wide, in the middle of which an allograft "Alloplant" measuring 100x11 mm, obtained from the broad fascia of the thigh, is sewn, while the anastomosis zone of the mesh and allograft is 20 mm on each side, and the total length of the prosthesis is 360 mm. The surgery was performed using a well-known technique: the claimed device was placed under the urethra and in the retropubic space via transvaginal access and two incisions in the suprapubic area. The prosthesis was installed using commonly used surgical instruments without violating symmetry so that the urethral tissue interacted with the allograft area. The prosthesis was not passed through the tissues without significant bleeding. After the prosthesis was installed, its tension was adjusted by moving the formed loop in the cranial and caudal directions until the minimum pressure on the urethra was achieved to retain urine during a cough test. Intraoperative blood loss was 50 ml, the operation time was 30 minutes. The postoperative period was uneventful. The patient retained urine completely during a cough test and physical activity. The patient was discharged from the clinic on the 3rd day after the operation.

Examinations performed 1, 3, and 6 months after the operation revealed complete urinary retention by the patient in the absence of complaints and pathological phenomena in the genitourinary system.

The advantages of this method are ease of use, high efficiency, absence of complications and side effects, which allows it to be successfully used in urology.

The use of the proposed prosthesis ensures the prevention of complications in the postoperative period and the risk of developing urethral erosion in patients with stress urinary incontinence due to the absence of a foreign body response and an anti-inflammatory macrophage reaction in the surrounding tissues of the allograft.

Claims (1)

A combined sling prosthesis for treating stress urinary incontinence in women, comprising a polypropylene mesh for a sling operation and an allogeneic graft sewn into the middle, characterized in that the allogeneic graft is an Alloplant allograft obtained from the broad fascia of the thigh, the polypropylene mesh has dimensions of 300×11 mm and is cut in the middle for suturing the Alloplant allograft, having dimensions of 100×11 mm, the anastomosis zone of the polypropylene mesh and the Alloplant allograft is 20 mm on each side, and the total length of the prosthesis is 360 mm, while the prosthesis is designed with the possibility of adjusting its tension until pressure is achieved on the urethra to retain urine during a cough test.