RU2580204C1 - Device for fixing implant in soft tissue - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, specifically to prosthetic urogynecology, and can be used to secure mesh implants in reconstruction of pelvic floor and surgical treatment of stress urinary incontinence in women. Device for fixing an implant in soft tissues, consisting of a handle with fixed to it a curved rod with a pointed end, which planted retainer yield tip of rod through upper edge of its central hole, characterised in that inner part of retainer has a tubular base member having a wall thickness 0 5 mm, a height of 1.5 mm and an inner diameter of 2 mm from bottom of which perpendicular to each other extend two pairs of sharp-cornered wings, one of which has with length of 5 mm, and other 3 mm, and upper part of outer portion of retainer is made equal to height a tubular portion and a truncated quadrangular pyramid, from middle of adjacent sides of base which depart wings triangular in cross section with a base length of 2.7 mm and a height of 1.5 mm, and all locking wings are angled 40 degrees toward its central axis depending on magnitude and direction of load angle change from 15 to 70 degrees, and in middle of both wings a length of 5 mm at a distance of 2 mm from upper edge of central opening latch located holes formed parallel to central axis, a diameter of 0.6 mm for fixing ligatures which together with locking pin planted on base diameter of which coincides with inner diameter of lock hole, and at a distance of 3.5 mm from tip is made conical transition 1.5 mm in length, starting with diameter 2 mm and diameter of main part of rod of 5-6 mm, situated in polymer tube-length stop at 10 mm rod length and internal diameter of 8 mm. Additionally there is a possibility of non-traumatic removal if necessary re-installation retainer due to shape and location of holes for fixing ligatures in upper part of retainer.

EFFECT: technical result of claimed invention is improvement of reliability of fixation by flat inner surface of four wings and possibility of their opening up to 70 degrees relative to central axis of retainer after dense connective structures, with simultaneous reduction of injuries accompanying retainer through dense tissue due to presence of faces on outer surface of wings and possibility of their pressing to base at angle to 15 degrees higher accuracy of setting with tension adjustment of mesh implant by using a tube-limiter and locking ligature.

1 cl, 5 dwg

Description

The invention relates to medicine, namely to prosthetic urogynecology, and can be used to fix mesh implants during pelvic floor reconstruction and surgical treatment of stress urinary incontinence in women.

A known retainer and tool for its introduction (WO 2004/017845; A61B 17/56, published March 4, 2004). The latch includes a cylindrical base from which two pairs of conical wings extend perpendicular to each other at an angle of 45 degrees from the central axis, the upper part of the cylindrical base being pointed and the ring through which the fixing tape is threaded. The tool for introducing the fixative into the tissue is a straight conductor with a special slot for the fixative and an internal complex mechanism of shooting the fixative after insertion.

The disadvantage of this clamp is its design and high material consumption. The sharp end of the base and rigid wings injure the surrounding tissue when holding the retainer, while the conical wings have a small area of support on the dense connective tissue structures, which reduces the holding capacity of the retainer. High material consumption increases the tissue response to the implantable fixative. The complex device of the tool for introducing the retainer complicates and increases the cost of its production and pre-operational processing.

Known direct sagittal retainer for strengthening mesh implants (RU 98105329; A61B 17/00, published December 20, 1999). The latch is a straight pin of square cross section, at the upper and lower ends of which there are swept branches formed by two wings, each wing has a section shape - an equilateral triangle, the wings forming the upper end of the latch are positioned relative to it at an angle equal to 45 degrees, on the lower end of the retainer, the wings are located relative to each other at an angle of 60 degrees.

Known surgical instrument for the treatment of urinary incontinence (RU 63206; A61B 17/00, published May 27, 2007). The tool consists of a curved element fixed to the handle with a pointed tip, the base diameter of which coincides with the diameter of the curved element, flexible disposable conductors with a through hole for threading the endoprosthesis, the pointed tip of the curved stainless steel element having the shape of a cylinder truncated at an angle of 20-30 ° from the side opposite to the inner bending radius of the curved element, with a rounded edge, and at a distance of 25-35 mm from the point of the pointed tip, a cone-shaped transition is made with a length of 4-6 mm starting from a diameter of 3-4 mm to the diameter of the main part of the curved element 5-6 mm, and at a distance of 10-15 mm from the tip of the pointed tip in the curved element there is a through oval hole in the form of an eyelet for passing through it a flexible a conductor with a tapered end and a hole for fixing a flexible conductor on the pointed tip of a curved element. The handle of the tool together with the curved element is made of stainless steel. The bending plane of the curved element is located in the direction of the longitudinal axis of the handle.

A device for treating seromas is known (RU 2452410; A61B 17/06, published June 10, 2012). The device includes a surgical suture made of absorbable material, means for fixing the suture in the depths of biological tissues and on the skin, and a means for passing the suture through biological tissues. The tool for fixing the surgical suture in the back of biological tissues is a core made of solid material. A surgical thread is attached to the rod in the middle of its length. The tool for fixing the surgical thread on the skin is a disk of solid material. The disk has two holes in the center for fixing the surgical thread. The means for holding the surgical suture to the attachment point with the means for fixing it in the depths of the biological tissues is a straight hollow needle with a mandrin. The needle is longitudinally dissected in one line so that a surgical thread can pass through the formed gap. EFFECT: invention makes it possible to effectively and reliably eliminate gray matter by compressing biological tissues and reducing its walls by arranging devices for compressing them through needles in the tissues.

Closest to the claimed is a mesh implant and a device for its fixation (US 8678995 B2; A61F 2/00, published March 25, 2014), including an endoprosthesis for surgical correction of stress urinary incontinence in women, with plastic retainers fixed at its edges, and tool for introducing fixatives into soft tissues. The tool consists of a handle, into which a straight tubular element is mounted, the distal end of which is a slot for a retainer, a cylindrical rod passes inside the tubular element, the proximal end of which is attached to a sliding mechanism built into the handle, and a latch is inserted on the distal pointed end with the outlet of the end rod through the central hole of the retainer. The plastic retainer includes a tubular base, in the center of which a hole is made with a diameter equal to the diameter of the rod, and two plane triangular wings extend from the side surface of the base opposite each other, and a mesh implant is attached to the base of the retainer. At the time of installation, the retractable mechanism pushes the retainer out of the socket and passes it through the tissue along with the implant.

Having a number of advantages, at the same time, the prototype has the following disadvantages. Namely, during installation and use, the triangular sharp wings of the retainer cut through the tissue both during installation and when loading on the retainer, which leads to increased bleeding of tissues; two small wings of a flat-shaped retainer have a small area of contact with tissues after administration; both lead to trauma to the surrounding tissues and reduce the reliability of fixation of the mesh implant, especially if the plane of the wings of the retainer is parallel to the fibers of the connective tissue structures. In addition, when using these implants, it is not possible to control the degree of tension of the mesh implant, which can lead to a lack of effect with insufficient tension of the endoprosthesis and impaired urination at too high a tension.

The technical result of the claimed invention is to eliminate these drawbacks, namely, improving the reliability of fixation due to the flat inner surface of the four wings and the possibility of their disclosure to 70 degrees with respect to the central axis of the retainer after passing dense connective tissue structures, while reducing trauma when holding the retainer through dense tissue due to the presence of faces on the outer surface of the wings and the possibility of pressing them to the base at an angle of up to 15 degrees, and e improve the accuracy Fitting with adjustable tension mesh implant by using the limiter and fixing the tube ligatures. Additionally, there is the possibility of atraumatic extraction if necessary, reinstalling the latch, due to the shape of the latch and the location of the holes for the fixing ligature in the upper part of the latch.

The problem is solved in that the device for fixing the implant in soft tissues, consisting of a handle with a curved rod fixed in it with a pointed end, on which a latch is inserted with the rod tip exiting through the upper edge of its central hole, and the inside of the latch has a tubular base with with a wall thickness of 0.5 mm, a height of 1.5 mm and an inner diameter of 2 mm, from the bottom of which two pairs of acute-angled wings extend perpendicular to each other, with a length of one pair of 5 mm, another 3 mm, and the upper part of the outer part of the retainer is made equal in height to the tubular part and is a truncated tetrahedral pyramid, the wings of which are triangular in cross section with the base 2.7 mm long and 1.5 mm high, extend from the middle of the adjacent sides of the base, and all the wings of the retainer are located at an angle of 40 degrees to its central axis with the possibility, depending on the size and direction of the load, angle changes from 15 to 70 degrees, and in the center of both wings 5 mm long at a distance of 2 mm from the upper edge of the central hole of the retainer Holes made parallel to the central axis with a diameter of 0.6 mm for the fixing ligature, which, together with the latch, are mounted on a rod, the base diameter of which coincides with the diameter of the inner hole of the latch, and at a distance of 3.5 mm from the tip, a cone-shaped transition 1.5 mm, starting from a diameter of 2 mm to a diameter of the main part of the rod 5-6 mm, are located in a polypropylene tube-limiter with a length of 10 mm shorter than the length of the rod and an inner diameter of 8 mm.

Significant differences of the claimed device are:

- the ability to change the angle of the wings with respect to the central axis due to the flexibility, shape and size of the acute-angled wings and their location in the retainer;

- the possibility of atraumatic extraction and reinstallation of the latch in case of its insertion into friable tissues due to the shape of the latch and the location of the holes for the fixing ligature in the upper part of the latch.

For a better understanding of the invention, FIG. 1 shows a diagram of a device for fixing an implant in soft tissues, consisting of a handle (1) with a rod fixed in it (2) with a pointed end (3), on which a latch (4) is mounted with the rod end exiting through the upper edge of its central hole ( 5), and the inner part of the retainer has a tubular base (6) with a wall thickness of 0.5 mm, a height of 1.5 mm and an inner diameter of 2 mm, from the bottom of which two pairs of acute-angled wings (7) extend perpendicular to each other, with a length one pair of 5 mm and another 3 mm, and the upper part of the outer part of the fix The ora is made equal in height to the tubular part and is a truncated tetrahedral pyramid, the wings of which are triangular in cross section with the base 2.7 mm long and 1.5 mm high, extend from the middle of the adjacent sides of the base, and all the wings of the retainer are located at an angle of 40 degrees from the central axis with the possibility of changing the angle from 15 to 70 degrees, and in the center of both wings 5 mm long at a distance of 2 mm from the upper edge of the central hole of the retainer there is a hole (8) for the fixing ligature (9) with a diameter of 0.6 mm, made parallel to the central axis of the tubular base, and the rod at a distance of 3.5 mm from the end has a conical transition (10) 1.5 mm long, starting from a diameter of 2 mm to a diameter of the main part of the rod 5-6 mm, and a latch with a ligature, mounted on the rod, located in the polymer restrictor tube (11) with an inner diameter of at least 8 mm and a length of 10 mm less than the length of the rod.

In FIG. Figure 2 shows a three-dimensional image of a retainer with a reflection of a central hole with a diameter of 2 mm (5), wings 3 mm (12) and 5 mm long (13), a face (14) on the outer surface of the wings and a hole (15) for the fixing ligature in the center of each wings 5 mm long at a distance of 2 mm from the edge of the upper central hole of the retainer.

In FIG. Figure 3 shows the outer and inner surfaces of the retainer with its cross section: the central hole (5), the face (14) on the outer surface of the wings (13), the hole (15) for the fixing ligature.

In FIG. 4 depicts the steps of using a device for fixing a mesh implant in soft tissues. At the first stage (B), after the isolation of dense connective tissue structures (16) (ligaments, membranes), the distal end of the restrictor tube (11) is installed on their surface in the required place. The second step (D) at the end (3) of the rod (2) is a latch (4), together with a fixing ligature (9) fixed to it. Next, the rod (2) with the retainer (4) mounted on it together with the fixing ligature (9) is carried out through the restrictor tube (11) to the surface of the ligament or membrane (16). At the time of passage through the restrictor tube (11), the wings (13) are pressed against the rod (2). In the third step (D), the pointed end (3) of the rod (2) together with the retainer (4) and the fixing ligature (9) passes through the dense connective tissue structures (16). Due to the pointed tip of the rod (3), the presence of faces (14) on the outer surface of the wings and pressing their inner surface to the rod (2) at the moment of passage of dense tissues (16), the trauma of the latter is minimized. After passing ligaments or membranes (16) and getting into friable tissues (17), the retainer (4) opens. Moreover, the depth of advancement of the rod (2) with the fixator (4) mounted on it is fixed in the tissues due to the stop of the proximal end of the restrictor tube (11) in the handle (1). At the last stage (E), the stopper tube along with the tool are removed, leaving the retainer (4) in the tissues together with the fixing ligature (9). The latter is tightened, so the wings open even more and their flat inner surface is in close contact with the inner surface of the connective tissue structure. Then, with the help of a fixing ligature, a mesh endoprosthesis is attached, the necessary tension of the latter is created.

In FIG. 5 shows the possibility of reinstalling the latch (4) if it is inserted past dense connective tissue structures. When the retainer is in loose tissue in the absence of contact with dense structures, due to the location of the holes (15) in the wings (13) 5 mm long close to the center and the presence of a second pair of wings 3 mm long (12), with the tension of the fixing ligature (9) the latch pivots (4). In this position, the latch is easily removed from the tissues and is ready for re-installation.

A device for fixing a mesh implant in soft tissues is manufactured using well-known technologies and equipment: a polypropylene retainer, a rod fixed in a medical stainless steel handle, a restriction tube made of polyethylene, polypropylene, polyvinyl chloride, a ligature made of non-absorbable material. The instrument used and the restrictor tube can be sterilized and used many times with a simple device.

Example clinical application of the device

Patient L., 62 years old, was hospitalized on 08/19/2014 at the SPKK FSBI “NMHTs im. N.I. Pirogov ", St. Petersburg in a planned manner with a diagnosis of" Cystocele 3 tbsp. Uterocele 2 tbsp. "For surgical treatment. Objectively: on a chair when straining, the protrusion of the front wall of the vagina is determined by 2/3 beyond the genital gap. 08/20/2014, taking into account damage to the pubic-cervical fascia and sacro-uterine ligaments, the mesh endoprosthesis was implanted using the claimed fixation device. During the operation, after paravaginal dissection and isolation of the sacrospinal ligaments on each side, the restrictor tube was installed directly on the ligament surface 2 cm from the spine, due to this, the exact insertion of the fixative in the desired location is achieved. A retainer mounted on the end of the rod, along with a retaining ligature, was inserted into the restrictor tube. The latter has an internal diameter less than the span of the wings of the retainer in a free state, which due to the possibility of changing the angle are tightly pressed against the rod and with minimal resistance are held to the surface of the ligament. The sharp end of the rod and the tight pressing of the restrictor tube to the surface of the ligament allow the retainer to enter into it in a compressed state, which minimizes tissue trauma. After passing through the connective tissue structure, the retainer enters the loose tissue, where its wings open. Due to its length, the stopper tube does not allow the retainer to be moved more than 10 mm into the tissues, which virtually eliminates damage to the underlying tissue structures. The restrictor tube and tool are retracted. When pulling on the fixing ligature, due to the possibility of changing the angle under load, the wings open even more, and their flat surface is in close contact with the inner surface of the ligament, which ensures high reliability of fixation. The same actions are performed on the other hand. Next, a mesh implant is attached to the fixing ligatures. The use of ligatures allows you to clearly adjust the tension and position of the endoprosthesis. The absence of the need to conduct trocars through the skin and deeper structures allows you to reduce the risk of damage to surrounding organs and reduce bleeding. All this made it possible to reduce the duration of the operation, increase the reliability of fixation, reduce trauma, and minimize the number of intraoperative complications. The postoperative period was uneventful. Urination is normal, fecal retention is sufficient, no pain. There are no complaints. Due to the lack of need for percutaneous holding of fixing strips, the rehabilitation period was reduced from 6 to 3 days. Discharged under the supervision of a gynecologist polyclinic. Examined 1 and 3 months after surgery. There are no complaints. There is no recurrence of cystocele.

Claims (1)

A device for fixing the implant in soft tissues, consisting of a handle with a curved rod fixed to it with a pointed end, on which a latch is mounted with the rod tip exiting through the upper edge of its central hole, characterized in that the inner part of the latch has a tubular base with a wall thickness of 0 5 mm, with a height of 1.5 mm and an inner diameter of 2 mm, from the bottom of which two pairs of acute-angled wings extend perpendicular to each other, with a length of one pair of 5 mm, the other 3 mm, and the upper part of the outer part of the latch in It is made equal in height to the tubular part and is a truncated tetrahedral pyramid, the wings of which are triangular in cross section with the base 2.7 mm long and 1.5 mm high, extend from the middle of the adjacent sides of the base, and all the wings of the retainer are located at an angle of 40 degrees to it the central axis with the possibility, depending on the size and direction of the load, of changing the angle from 15 to 70 degrees, and the holes are located in the center of both wings 5 mm long at a distance of 2 mm from the upper edge of the central hole of the lock parallel to the central axis with a diameter of 0.6 mm for the fixing ligature, which, together with the latch, are mounted on a rod whose base diameter coincides with the diameter of the inner hole of the latch, and a cone-shaped transition 1.5 mm long is made at a distance of 3.5 mm from the tip, starting from a diameter of 2 mm to a diameter of the main part of the rod 5-6 mm, are located in a polymer tube-limiter 10 mm shorter than the length of the rod and an inner diameter of 8 mm

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