RU2670914C9 - Mesh base-knitted combined endoprosthesis for plastics of inguinal hernia - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to surgery. Endoprosthesis reticular, warp-based combined for plastics of inguinal hernia has a soft and hard zone of synthetic filaments, soft and hard zones are made at a ratio of 1:2 width from synthetic monofilaments with a diameter of 0.120±0.005 mm, smaller zone consists of polyvinylidene fluoride monofilaments with a rigidity of the grid for bending along the loop row from 11 cN⋅mm² up to 13 cN⋅mm² and along the column from 6 cN⋅mm² up to 8 cN⋅mm², and a large zone consists of polypropylene monofilaments with a rigidity of the grid for bending along the loop row from 32 cN⋅mm² up to 34 cN⋅mm² and along the column from 24 cN⋅mm² up to 26 cN⋅mm².

EFFECT: invention allows to reduce traumatism, to avoid the formation of a gross connective tissue scar.

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Description

The claimed invention relates to medicine, namely to reconstructive surgery, and can be used to perform non-tensioning hernioplasty of inguinal hernias taking into account the biomechanical concept of their pathogenesis.

Surgical treatment of abdominal hernias is performed annually in the world in more than 20 million patients, of which about 200 thousand are in Russia [Parshikov V.V., Fedaev A.A. Prosthetic plastic surgery of the abdominal wall in the treatment of ventral and postoperative hernias: classification, terminology and technical aspects (review) // Modern technologies in medicine. - 2015, vol. 2 (7). - S.138-152]. In almost 75% of cases, patients undergo hernioplasty for inguinal hernias [Vorobev V.V. Methodology for the treatment of inguinal hernias // Outpatient surgery. - 2002, No. 1 (5). - S.17-20]. The widespread introduction of prosthetic technologies into hernia surgery led to the achievement of significant successes in herniology. The use of synthetic polymers endoprostheses in hernioplasty can significantly improve the results of surgical treatment of inguinal hernias. At the same time, along with the technique of surgical intervention, the quality of the endoprosthesis and, in particular, its design, are important.

One of the common modern surgical technologies for the elimination of inguinal hernias is laparoscopic transabdominal preperitoneal hernioplasty (Trans Abdominal Preperitoneal Plasty - TAPP) [B.H. Egiev, P.K. Resurrection. Hernias. - Moscow: Publishing House Medpraktika-M, 2015. - S.185-203].

A feature of TAPP without bringing the implant under the elements of the spermatic cord or uterine round ligament (which helps to reduce the likelihood of various complications) is the targeted careful separation and mobilization of the parietal peritoneum with the installation of a mesh prosthesis over them. The repetition of the anatomical bends in the inguinal zones by the prosthesis helps to reduce the severity of the operating injury, reduce the length of hospital stay, accelerate the recovery of motor activity, improve the quality of life of patients and a high degree of guarantee for the prevention of relapse.

It is known [Zhukovsky V.A. Polymer endoprostheses for hernioplasty. - St. Petersburg: Aesculapius, 2011. P.46-49], that mesh endoprostheses from polyvinylidene fluoride (PVDF) monofilaments are softer than from polypropylene (PP) monofilaments and are more biocompatible, i.e. the inflammatory reaction of tissues to them is less pronounced and does not cause powerful scar formations. The softness of such an endoprosthesis or its part allows you to maximize repeat the anatomical forms of the structures of the inguinal region.

At the same time, the endoprosthesis or part of it from PP monofilaments has sufficient rigidity to maintain shape and ensure ease of installation, which makes possible good adhesion and tight integration of the endoprosthesis in the tissue of the anterior abdominal wall, while strengthening the groin area mechanically.

Known composite mesh warp knitted endoprosthesis, consisting of 50% or 75% of the volume of material from PVDF monofilament and 50% or 25% of PP monofilament [Zhukovsky V.A. Polymer endoprostheses for hernioplasty. - St. Petersburg: Aesculapius, 2011. P.49]. The endoprosthesis is well straightened in the surgical field, but due to stiffness, a pronounced connective tissue scar is formed on it.

Closest to the claimed invention is an endoprosthesis made of a multifilament (complex) polyester yarn and consisting of two mesh plates (hard and soft) connected together by an overcast seam of multifilament twisted polyester yarns on an overlock machine (patent US 6066777, May 23, 2000. Anatomical prosthesis for the repair of hernias by a laparoscopic or open route). The rigid plate is a two-dimensional mesh with rectangular cells, the soft one is a volumetric porous mesh with hexagonal cells. A cut is made along the border of the soft and hard plates, ending with a round hole for holding the spermatic cord. After placement of the endoprosthesis, the incision is sutured with brackets or surgical suture. Since the connection is unreliable, there is a risk of rupture of this part of the endoprosthesis under the influence of intra-abdominal pressure and trauma to the spermatic cord, uterine round ligament and iliac vessels, as well as hernia recurrence. Injury to the elements of the inguinal region is also possible as a result of contact in the hole with the rigid part of the endoprosthesis. It is possible to infect endoprostheses from polyfilament filaments having pores between the filaments of the order of 10-15 microns, because microorganisms (about 1-2 microns in size) easily penetrate into them, but macrophages (18-35 microns) cannot get in, which prevents the development of an adequate immune response of the body to infection pathogens. This is especially true for the volumetric part of the endoprosthesis and the suture between the plates. The presence of a nutrient medium in the wound and a favorable temperature contribute to the colonization of the endoprosthesis by microflora. In addition, as a result of the reaction of the body to the polyester material around the endoprosthesis and, especially, in the suture area, a coarse connective tissue scar forms, which creates a patient's foreign body sensation and leads to a restriction of the mobility of the abdominal wall.

The technical result of the claimed invention is to eliminate these drawbacks, namely, reducing the number and severity of postoperative complications by simultaneously reducing morbidity and infection by performing an endoprosthesis integrally knitted from PVDF and PP monofilaments with a given diameter and zones.

The result is ensured by creating a soft zone of PVDF monofilaments in the endoprosthesis that maximally repeats the anatomical structures of the inguinal region, such as the spermatic cord, uterine ligament, iliac vessels, and by integrally joining the PP monofilament zone to it, giving the endoprosthesis the necessary rigidity for convenient and quick placement him into the prepared bed.

The problem is solved in that in the endoprosthesis of a mesh warp knitted combined for inguinal hernia repair, having soft and hard zones of synthetic threads, the soft and hard zones in an all-knitted endoprosthesis are made with a 1: 2 width ratio of synthetic monofilaments with a diameter of 0.120 ± 0.005 mm, the zone consists of PVDF monofilaments with bending stiffness along the loop from 11 cN⋅mm ² to 13 cN⋅mm ² and along the loop from 6 cN⋅mm ² to 8 cN⋅mm ² , the large zone consists of PP monofilaments with stiffness nets b along the hinge row from 32 cN⋅mm ² to 34 cN⋅mm ² and along the hinge column from 24 cN⋅mm ² to 26 cN⋅mm ² .

The essential features of the proposed solution is the combination of the distinguishing features of the endoprosthesis described above, some of which provide a known result: softness, biocompatibility and lack of infection of PVDF monofilaments, as well as a combination of PVDF and PP monofilaments in the endoprosthesis for hernia repair (patent No. 2524308 of the Russian Federation, IPC A61F 2/02, A61B 17/00. Basic mesh knitted endoprosthesis, reinforced for inguinal hernia repair (options) and method of its use). However, only the claimed combination of features provides a technical result that is not equal to the sum of the results from the stated well-known features, which allows us to conclude that the differences are significant, that is, inventive step.

For a better understanding of the invention, FIG. 1 shows a general view of a rectangular endoprosthesis of length l ₁ and width l ₂ + l ₃ , having zone 1 of PP monofilament and zone 2 of PVDF monofilament. The warp knitted mesh endoprosthesis with dimensions of at least 12.0 cm in length and 8.0 cm in width is made of 1/3 of PVDF monofilaments with a diameter of 0.120 ± 0.005 mm, and 2/3 of PP monofilaments with a diameter of 0.120 ± 0.005 mm. In order to better visualize the seamlessly knitted compound of PVDF and PP zones, blue-dyed PVDF monofilament was used.

The claimed endoprosthesis is obtained and can be repeatedly reproduced on a warp knitting machine equipped with compound needles and two ear combs, the operation of which is described by an analytical record: first 1/0; 2/3; 4/5; 3/2; second 1/0; 2/3; 3/2; 2/3. A graphic record of weaving and analytical records of the work of the ear combs are presented in FIG. 2. The whole-knit connection of the hard zone 1 of PP monofilament and soft zone 2 of PVDF monofilament shown in FIG. 3, it is formed by dressing each eyelet comb with PP and PVDF simultaneously with monofilaments, while the number of threaded N threads for each zone is calculated in accordance with their sizes l ₂ and l ₃ , as well as the value of the inter needle needle gap t _ig .

N _PP = l ₂ / 2t _ig

N _PVDF = l ₃ / 2t _u

The properties of the endoprosthesis are shown in the table.

The claimed endoprosthesis can be implanted using the TAPP technique. During implant implantation, the rigid PP zone is positioned higher and the soft PVDF zone is lower than the partartic ligament, the whole-knit connection of one zone to another is placed along the partarticulite, while the PP zone provides stiffness for the endoprosthesis to be conveniently placed, and repetition of the soft PVDF part of the prosthesis of anatomical bends in the inguinal bend The area creates conditions under which fixation of the implant is either not required, or (with a large hernia gate size) its rare use significantly reduces tissue trauma, and, as a result, reduces int intensity of pain in the postoperative period.

Case Studies

Example 1. In the City Center for Modern Surgical Technologies GBUZ "City Clinical Hospital No. 31", St. Petersburg, in a planned manner on March 14, 2017, a patient, aged 35, was admitted for surgical treatment. Diagnosis: Left-sided inguinal hernia.

Considers herself ill for 2 years, when a hernial protrusion in the left inguinal region first appeared.

Concomitant diseases: chronic gastritis, chronic pyelonephritis.

In the left inguinal region, a hernial protrusion of 3 × 4 cm. The external inguinal ring on the left is expanded to 1.5 cm.

03/15/2017, the patient underwent laparoscopic hernioplasty according to the TAPP method with the installation of a mesh warp knitted combined endoprosthesis of rectangular shape measuring 12.0 × 8.0 cm, having soft and hard zones of synthetic threads, characterized in that the soft and hard zones in an all-knitted endoprosthesis made with a 1: 2 width ratio of synthetic monofilaments with a diameter of 0.120 ± 0.005 mm, and the smaller zone consists of PVDF monofilaments with a bending stiffness along the loop of 11 cN сmm ² and along the loop of 7 cN⋅m m ² , the large zone consists of PP monofilaments with a mesh rigidity of bending along the stitch row 33 sN⋅mm ² and along the loop stitch 24 sN⋅mm ² .

Under endotracheal anesthesia, laparocentesis was performed at the lower umbilical point. Carbon dioxide insufflation under pressure up to 12 mm. Hg When viewed in the abdominal cavity, there is no effusion. In the left inguinal region (fossa inguinalis medialis) there are hernial gates with a diameter of 3 cm. No other visible pathological changes in the abdominal cavity were detected. The parietal peritoneum was dissected with a bordering incision and separated with a 5 × 4 × 3 cm hernial sac. Fenestration of the transverse fascia was performed. A mesh base-knitted combined endoprosthesis of a rectangular shape with dimensions of 12.0 × 8.0 cm was installed, without bringing under the elements of the spermatic cord and with covering all the fossae (lateral, medial, femoral) of the inguinal-iliac region. The location of the endoprosthesis was made so that its upper part from the PP monofilament was higher than theparticular ligament, and the lower one from PVDF monofilament, was superimposed on the elements of the spermatic cord and external iliac vessels. Under clear visual control, a herniostapler was fixed at the edges of the endoprosthesis in 6 places and in the area of the Cooper ligament without involving the vessels and nerve trunks in the attachment zone. The endoprosthesis is peritonized. Control inspection. Desufflation. The wound is sutured by PP monofilament.

Postoperative diagnosis: Left-sided direct inguinal hernia.

The postoperative period was uneventful. The patient complained of some discomfort in the area of sutured trocar wounds and the projection of the location of the endoprosthesis. Edema of the elements of the spermatic cord and scrotum was not observed. Prescribing potent painkillers was not required. In satisfactory condition, the patient was discharged the next day after surgical treatment. Sutures were removed on the 7th day. Healing of trocar wounds by primary intention. Dysfunction of urination and gastrointestinal tract was not noted.

At the follow-up examination 04/18/2017, the patient feels satisfactory, no complaints. According to the patient, sexual activity and functionality are fully preserved. Dysfunction of urination and gastrointestinal tract is not noted. Leads an active lifestyle, plays sports, is unlimited in movements. He began to work in full in March 27, 2017.

Example 2. In the City Center for Modern Surgical Technologies GBUZ "City Clinical Hospital No. 31", St. Petersburg, in a planned manner on 04.04.2017, patient A., aged 42, was admitted for surgical treatment. Diagnosis: Right-sided inguinal hernia.

Considers herself ill for 1 year, when a hernial protrusion in the right inguinal region first appeared.

Concomitant diseases: urolithiasis, chronic hemorrhoids.

A 5 × 5 cm hernial protrusion is palpated in the right inguinal region. The external inguinal ring on the right is expanded to 2 cm in diameter.

04/05/2017, the patient underwent laparoscopic hernioplasty according to the TAPP method with the installation of a mesh warp knitted combined endoprosthesis with dimensions of 15.0 × 10.0 cm, having soft and hard zones of synthetic threads, characterized in that in the whole knitted endoprosthesis, the soft and hard zones are performed with width ratio of 1: 2 of synthetic filaments with a diameter 0.120 ± 0.005 mm, the smaller area is composed of PVDF monofilament mesh with bending stiffness along the stitch row 11 sN⋅mm ² and along the wales 7 sN⋅mm ^2, a large area consisting t PP monofilament mesh with bending stiffness along the stitch row 34 sN⋅mm ² and along the wales 26 sN⋅mm ^2.

Under endotracheal anesthesia, laparocentesis was performed at the lower umbilical point. Carbon dioxide insufflation under pressure up to 12 mm. Hg When viewed in the abdominal cavity, there is no effusion. In the right inguinal region (fossa inguinalis lateralis) there are hernial gates with a diameter of 3.5 cm. There were no other visible pathological changes in the abdominal cavity. The parietal peritoneum was dissected with a bordering incision and separated with a hernia sac 6 × 5 × 6 cm in size. A mesh base knitted combined endoprosthesis of a rectangular shape with dimensions of 15.0 × 10.0 cm was installed without leading under the elements of the spermatic cord and with covering all the fossae (lateral, medial , femoral) inguinal-iliac region. The location of the endoprosthesis was made so that its upper part from the PP monofilament was higher than theparticular ligament, and the lower one from PVDF monofilament, was superimposed on the elements of the spermatic cord and external iliac vessels. Under clear visual control, a herniostapler was fixed at the edges of the endoprosthesis in 6 places and in the area of the Cooper ligament without involving the vessels and nerve trunks in the attachment zone. The endoprosthesis is peritonized. Control inspection. Desufflation. The wound is sutured by PP monofilament.

The postoperative period was uneventful. The patient did not make complaints. Edema of the elements of the spermatic cord and scrotum was not observed. Painkillers were not prescribed. In satisfactory condition, the patient was discharged the next day after surgical treatment. Sutures were removed on the 7th day. Healing of trocar wounds by primary intention. Dysfunction of urination and gastrointestinal tract was not noted.

At the follow-up examination on 05/15/2017, the patient is in satisfactory condition, no complaints. An objective examination of the asymmetry of the inguinal zones is not observed. Dysfunction of urination and gastrointestinal tract was not noted. Leads an active lifestyle, unlimited in movements. Complaints from the sexual function does not show. He began to work in full in April 17, 2017.

With similar use in women, the soft part of the endoprosthesis of PVDF monofilament repeats the bends of the anatomical structures of the inguinal region and provides atraumaticity of the round ligament of the uterus and iliac vessels.

Thus, the claimed endoprosthesis is used in inguinal hernia repair, which reduces the number and severity of postoperative complications by simultaneously reducing trauma and infection by performing an endoprosthesis seamlessly made from PVDF and PP monofilaments with a given diameter and zones, which ensures the creation of a soft zone from PVDF in the endoprosthesis. monofilament, maximally repeating the anatomical structures of the inguinal region, such as elements of the spermatic cord, uterine round ligament, iliac vessels, and c lnovyazanym joining her area of PP monofilaments endoprosthesis imparts the necessary rigidity for easy and quick placing it in the prepared bed.

Claims (1)

The base knitted mesh endoprosthesis combined for inguinal hernia repair, having soft and hard zones made of synthetic threads, characterized in that the soft and hard zones in an all-knitted endoprosthesis are made with a 1: 2 width ratio of synthetic monofilaments with a diameter of 0.120 ± 0.005 mm, and the smaller zone consists of polyvinylidene fluoride filaments with a mesh bending stiffness along the stitch number of 11 to 13 sN⋅mm ² sN⋅mm ² and along the wales of 6 sN⋅mm ² to 8 sN⋅mm ^2, and a large area consists of polypropylene monofilaments with rigidly Tew grid bending along the stitch number from ² to 32 sN⋅mm 34 sN⋅mm ² and along the wales of 24 ² to 26 sN⋅mm sN⋅mm ^2.

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