RU2780140C1 - Device for suitation of tissue defects - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: invention relates to medical equipment, namely to devices for suturing tissue defects, and can be used for gradual tightening of wound edges. A device for suturing tissue defects contains a base on which at least one support element is located, in which a hollow rod is fixed, a second base identical to the first one, with at least one support element located on it with a hollow rod fixed therein. The bases are made in the form of a plate with holes, each supporting element is made in the form of a disk with a groove; element. Inside the hollow rod there is a stylet with a hole for the ligature, the stylet has a platform for holding it with a needle holder, and the hole for the ligature is located on the cutting part of the stylet.

EFFECT: use of the invention makes it possible to create sparing conditions for wound healing due to the transfer of force when tightening the ligatures and bringing the edges of the wound to the supporting elements and the base, excluding the effect of the ligatures on the tissues and their eruption.

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Description

SUBSTANCE: invention relates to medical equipment, namely to devices for suturing tissue defects, and can be used for gradual tightening of wound edges, for example, during laparostomy, preventing ligatures from cutting through tissues, due to uniform load distribution between ligature guides and support plates.

The most difficult task in surgery is the closure of a laparotomic wound after several relaparotomies or eventration with wound suppuration. The abdominal wall along the edges of the wound in such cases becomes rigid due to cicatricial changes and muscle contraction, its layers do not differentiate. An attempt to suture an abdominal wall defect ends with eruption of the sutures and its long-term healing by secondary intention with the formation of an incisional hernia. In cases of formation of intestinal fistulas, closure of the defect is difficult due to the aggressive action of digestive juices and skin maceration. Self-healing of such defects is almost impossible, and there are no reliable methods of plastic closure. Mortality in such situations reaches 40-60%.

To tighten the edges of the wound with extensive tissue defects, lamellar sutures are used. Lamellar seams or seams with supporting elements have many modifications. Their main task is to reduce the load on the tissue at the point where the thread passes through the skin and prevent tissue eruption. The most commonly used improvised means are PVC pipes for drainage or systems. Buttons or other flat objects of any material may be used. On the Russian market, there are no devices manufactured by the domestic industry for closing tissue defects. But many methods are described for closing such defects using the above improvised means.

For example, Huseynov A.G. and Huseynov A-K.G. propose to use lamellar seams from pieces of wire 8-12 cm long, curved in the form of closed loops [patent RU No. 2307603, IPC A61B 17/03, publ. 10.10.2007]. Loops can be made from paper clips or wire for osteosynthesis by bending the wire into a loop and connecting the ends of the wire with a “twist” of 2-3 turns. The authors also suggest flattening the wire on the anvil with a hammer, and then forming additional bends in the center of the loop for a reserve of length and at the edges to hold the loop between the mattress seams. The loops are installed (placed) under the stitches of the thread after the mattress sutures are applied to the wound.

Earlier in 2001, these authors proposed another method for applying lamellar sutures, the essence of which is as follows [patent RU No. 2277388, IPC A61B 17/04, publ. 06/10/2006]. After applying vertical mattress sutures to the wound according to Donati, the skin part of both loops of the suture is lifted with tweezers or a needle and a bracket containing a loop is inserted into it, on the other side of the loop another bracket is inserted, introducing it also into the loop of the first bracket, while the legs the brackets are threaded into each other's loops, the legs of the bracket are bred, increasing the degree of adaptation of the edges of the wound. Staples are made from wire or paper clips. The wire staples can be removed or replaced if necessary and do not interfere with the outflow of wound discharge from the wound.

From patent RU No. 2751127 (IPC A61B 17/04, publ. 07/08/2021) it is known to reduce the edges of the wound by applying a U-shaped mattress horizontal seam on tubular protectors using threads passed through all layers of the wound. The threads are not connected, but both ends of the threads are passed in the opposite direction intradermally at both edges of the wound, then they are passed through the tubular protector on the opposite side and tied.

However, the above analogues have a common drawback - the supporting elements are located on the skin, and the thread connecting the edges of the wound, as a rule, passes through the entire thickness of the tissues. As a result, the thread under load cuts through the tissues in the depth of the wound, which, with large defects and significant loads on the sutures, impairs healing and does not provide adaptation of the deep layers in the wound walls.

Also known is a method of suturing a laparotomic wound during eventration using PVC tubes [patent RU No. 2691321, IPC A61B 17/04, publ. 06/11/2019]. The method differs in that symmetrical channels are formed with a 5 mm trocar, penetrating the skin, subcutaneous tissue, anterior leaf of the rectus aponeurosis, rectus muscle, posterior leaf in an oblique tangential direction to the wound so that it is in the preperitoneal tissue and does not touch the peritoneum. Then, polyvinyl chloride tubes are inserted into the formed channels using a Kocher clamp, which are pulled together and fixed with a thread.

Due to the thickness and elasticity of the tube, the load is distributed evenly in the tissues, as a result, trophic processes are not disturbed and tissue eruption does not occur. In addition, it is possible to adapt the deep layers of the abdominal wall, which carry the main mechanical load.

However, the method does not provide for the regulation of the tension force, which does not allow to gradually reduce the edges of the wound with significant defects.

Special devices and systems for suturing wounds are also known. For example, the wound edge reduction system - TopClosure Tension Relief System (TRS) [http://survmed.ru/catalog/sredstva-ot-porezov-i-ssadin/sistema-svedeniya-kraev-ran-topclosure-tension-relief-system -trs/]. The TopClosure Tension Relief System includes two locks with a locking mechanism and a special tape, which is a notched tie. The lower edges of the locks have an adhesive layer, which allows them to be glued to the body of the victim in the right place next to the wound. Locks can also be fixed to the skin using a surgical stapler. At the top of the locks there is a special ledge through which the screed is threaded. Entering one of the locks, she passes through the second and begins to pull them towards each other, bringing them together. This allows you to bring the edges of the wound closer and pull them close.

The device is convenient to use. However, being attached only to the skin, it does not allow to compare tissues in the depth of the wound. As a result, for example, when suturing a laparostomy, the edges of the aponeurosis may diverge, which will lead to the formation of a hernia.

Some time ago, the "gold standard" for temporary closure of the laparostomy was the Wittmann bandage (Wittmann Patch). Wittmann Patch is described in several patents: US2004221431A1; US2010114160A1; US2010256674A1; US2012024462A1; US7662169B2; US8128655B2; US8469996B2 (“Prosthesis and method for lowering abdominal pressure”). The dressing is a "fascia prosthesis" in the form of two sheets attached to the aponeurosis from opposite sides of the incision. One side of each sheet is provided with mating fasteners that, when connected, provide high tensile shear strength and low peel resistance, allowing them to be easily separated when reopening the abdomen is required. The bandage is similar to a Velcro fastener. When used, the bandage gradually tightens the deep layers of the wound, which subsequently, after stopping the inflammation, allows you to sew the edges of the aponeurosis.

The Trans-Abdominal Wall Traction (TAWT) technique is discussed in detail in Dennis A, Vizinas TA, Joseph K, Kingsley S, Bokhari F, Starr F, Poulakidas S, Wiley D, Messer T, Nagy K. Not so fast to skin graft: transabdominal wall traction closes most "domain loss" abdomens in the acute setting. J Trauma Acute Care Surg. 2013. The authors place sheets of dressing in the abdominal cavity and fix them from the side of the peritoneum through all layers of the abdominal wall to semi-rigid rollers measuring 1×9 inches, located on the skin along the outer edge of the rectus abdominis muscles. The sheets are stretched and connected with a "sticky" surface containing hooks and loops. During treatment, negative pressure therapy (VAC) is mandatory.

Despite the ease of use, two sheets of dense material with fasteners, located in two layers, limit the free outflow of exudate from the abdominal cavity. This reduces the effectiveness of drainage and requires the use of negative pressure therapy.

Closest to the claimed are the system for moving and stretching plastic tissues (patent RU No. 2299696, IPC A61B 17/03, publ. 27.05.2007). The system comprises at least one non-reactive elastomeric force application component that is biologically inert or hypoallergenic and at least one anchor device for attaching to tissue. The anchor device includes opposing flat or arcuate surfaces for compressing and engaging the force application component to provide controlled attachment of the force application component without tangling and without being cut by said surfaces. As a result, the system generates a relatively constant dynamic force over various distances and in various directions, which are adjustable and self-adjusting.

The authors have described several embodiments of the force application component and anchor devices. In particular, an elastomeric force application component is described in the form of an elastic tube, which can be passed through tissues using a trocar to the point of maximum load and is able to dissipate the load. A force application component is also described, consisting of two elements - elastic and inelastic. The claims further state (claim 26) that the force application component can pass through the fabric and through the hole in the anchor device.

The method of using the abdominal anchor system is illustrated in detail in the poster of the University Medical Center of Southern Nevada [Cinelli SM, Casey MJ, Kuhls DA, Browder TD, Coates JE, Fildes JJ. Early Primary Closure of Open Abdominal Wounds Using the Abdominal Reapproximation Anchor (ABRA®) System. University of Nevada School of Medicine, Division of Trauma and Critical Care, University Medical Center of Southern Nevada, Las Vegas, NV. Poster session presented at the Southwestern Surgical Congress, Coronado, CA; March, 2009, https://www.researchgate.net/publication/238681641_Closure_of_the_Open_Abdomen_Using_the_Abdominal_Reapproximation_Anchor_System].

The disadvantage of the device is the preservation of lateral pressure on the tissue of the components of the application of force when tightening the edges of the wound. When using the device, the load is distributed not only along the force application components, but also at an angle to their axis. As a result, the load is transferred not only to the anchor device, but also to the tissues around the force application components, which deforms the tissues and leads to trophic disorders. Thus, the force application components cut through tissue, as do ligatures in other defect closure devices.

The technical problem lies in the development of a device for suturing tissue defects, providing a reduction in complications and a favorable course of the wound process in the postoperative period.

The technical result consists in creating gentle conditions for wound healing by transferring force when tightening the ligatures and bringing the edges of the wound to the supporting elements and the base, excluding the effect of the ligatures on the tissues and their eruption.

The technical result is achieved by the fact that in a device for suturing tissue defects, containing a base on which at least one support element is located, in which a hollow rod is fixed, according to the solution , the device contains a second base, identical to the first, with located on it, at least one support element with a hollow rod fixed in it, the bases are made in the form of a plate with holes, each support element is made in the form of a disk with a groove, a fixation mechanism with a longitudinal groove is located perpendicular to the disk and is made integral with it for fixing the hollow the rod, which has on one side a platform with a hole for attaching to the support element, a stylet with a hole for a ligature is located inside the hollow rod, the stylet has a platform for holding it with a needle holder, and the hole for the ligature is located near the cutting part of the stylet.

The supporting element is made with holes.

The hollow rod is fixed with a wing screw and a washer.

The hollow rod is made in the form of an arc-curved tube made of a polymer or composite material.

The essence of the invention is illustrated by drawings, where:

- in Fig. 1 shows the elements of the device for suturing tissue defects in disassembled form;

- in Fig. 2 shows the base with support elements placed on it, in which hollow rods are fixed;

- in Fig. 3 shows the sequence of actions characterizing the operation of the proposed device, where A is stitching one edge of the wound; B - stitching the second edge of the wound; B - tightening the edges and fixing the ligature.

Positions in the drawings indicate:

1 - base,

2 - guide for ligatures,

3 - support element,

4 - base holes,

5 - hollow rod (tube),

6 - a platform for a hollow rod for a needle holder,

7 - hole for the ligature fixation mechanism,

8 - stylet,

9 - the cutting part of the stylet in the form of a trihedron,

10 - chute for ligature,

11 - hole for the ligature,

12 - stylet platform for the needle holder,

13 - plate of the support element in the form of a disk,

14 - mechanism for fixing the support element,

15 - longitudinal groove in the plate of the supporting element for the wing screw,

16 - wing screw,

17 - puck,

18 - groove of the support element plate,

19 - holes of the support element plate,

20 - the edge of the laparotomic wound,

21 - skin,

22 - subcutaneous tissue,

23 - aponeurosis,

24 - peritoneum,

25 - ligature,

26 - the first end of the ligature,

27 - the second end of the ligature.

The base 1 is made in the form of a plate with a plurality of holes 4 (Fig. 1). The base 1 is made of a polymeric material to provide the possibility of changing its dimensions to the required size along the wound contour. The guide for ligatures 2 is a hollow rod 5, made in the form of a tube bent in an arc with straight open ends, one of which has a platform 6 with a hole 7 for the mechanism for fixing the ligature 14 of the support element 3. Inside the hollow rod 5 there is a stylet 8. One from the ends of the stylet 8 is a cutting part in the form of a trihedron 9 with a groove 10 and a hole 11 for the ligature, and the other end is a flat platform 12 for holding the stylet with a needle holder. The hollow rod 5 is made of a polymer or composite material to enable it to be cut in accordance with different thicknesses of the abdominal wall.

In the assembled form, the platform 12 of the stylet 8 and the platform 6 of the hollow rod 5 are tightly adjacent to each other, which makes it possible to simultaneously hold both elements of the device with the needle holder when sewing fabrics. In this case, the cutting part 9 of the stylet 8 protrudes from the hollow rod 5, and the hole 11 for the ligature can remain inside the hollow rod 5.

The support element 3 is made in the form of a disk, it is a plate with holes 13, in the center of which there is a locking mechanism 14 with a longitudinal groove 15 for the wing screw 16, which fixes the support element 3 to the guide for the ligature 2. When the wing screw 16 is tightened, the ligature is pressed against the mechanism fixation 14 with washer 17 having an internal thread, and is fixed. The plate 13 has a groove 18, which allows you to install the support element 3 so that the guide for the ligature 2 is located closer to the center of the plate 13, and the platform 6 and the locking mechanism of the support element 14 are in close contact. Support element 3 can be made of any material approved for use in medicine: metal, polymer, composite material, etc. Plate 13 can have holes 19 for connecting two support elements using a surgical suture.

In FIG. 2 shows the base with support elements placed on it, in which hollow rods are fixed. For the operability of the proposed device, it is necessary to use a second base, identical to the first, with supporting elements located on it, in which hollow rods are fixed.

The operation of the device is illustrated by figure 3.

Along the edges of the laparotomic wound 20, the bases 1 are symmetrically placed, not exceeding the thickness of the abdominal wall in width (Fig. 3A). The number of guides for ligatures 2 is determined by the length of the wound.

With a large thickness of the abdominal wall, the center of the base should be located at a distance from the edge of the wound, equal to the thickness of the abdominal wall. The maximum width of the base is 7 cm. Next, using a needle holder through the holes 4 in the base 1, the skin 21 and the underlying tissues - subcutaneous tissue 22 of the guide for ligatures 2 are pierced using the cutting part 9 of the stylet 8. In this case, it is necessary to bring the stylet of the guide for ligatures 2 to the edge wound preperitoneally, that is, capturing the aponeurosis 23, but without piercing the peritoneum 24. Next, you need to push the stylet 8 inside the hollow rod 5 so that a hole 11 for the ligature appears from the hollow rod 5. A strong ligature 25 or a fishing line of the appropriate thickness is carried out into the hole 11 using a surgical needle. Then the stylet 8 is removed from the hollow shaft 5 in the opposite direction, dragging the first end of the ligature 26 through the hollow shaft 5, and the hollow shaft 5 remains in the tissues. A guide for ligatures 2 is similarly passed through the opposite edge of the wound at a symmetrical point, stylet 8 is advanced, and the second end of ligature 27 is passed into hole 11 and pulled with stylet 8 through hollow rod 5 to the opposite edge of the wound (Fig. 3B).

Next, along each of the edges of the wound, tissues are sequentially stitched using guides 2 at a distance of about 3 cm from each other, and, connecting the edges of the wound, ligatures are passed through them. A support element 3 is attached to each guide 2 by means of a wing screw 16 (FIG. 3B). In this case, the platform 6 and the locking mechanism of the support element 14 are adjacent to each other, and the plate 13 is firmly installed on the bases 1. The bases 1 can be sewn together with a surgical suture. The groove 15 allows you to adjust the relative position of the platform 6 and the mechanism for fixing the support element 14 before tightening the thumb screw 16, depending on how much the platform 6 rises above the skin. Then, sequentially from one of the corners of the wound, all the ligatures are smoothly pulled until the aponeurosis touches and pressed against the platform 6 using the washer 17 while tightening the screw 16. Depending on the clinical situation and the condition of the wound edges, additional sutures can be applied to the skin.

In abdominal surgery, the device can be used during laparostomy, when it is necessary to temporarily reduce the edges of the surgical wound, for example, with severe peritonitis or pancreatic necrosis. Repeated sanitation of the abdominal cavity is performed, as a rule, on the second or third day. The total duration of treatment can be two to three weeks. Sometimes 5-7 (or more) repeated interventions may be needed - software relaparotomies or relaparotomies on demand. During relaparotomy, the hollow rods 5 for ligature guides remain fixed to the supporting elements 3 and are not removed from the tissues. Thumb screws 16 are untwisted on all elements only in order to unclench the ligatures 25. The ligatures are removed from the guides 2 and the edges of the wound are bred. After performing the sanitation of the abdominal cavity using the stylet 8, the ligatures are again passed through the hollow rods 5, tightened to reduce the edges of the wound and fixed with the wing screws 16. In this case, the tissues are not pierced, and a new wound channel is not created for the ligature or other tightening element. Bases 1, supporting elements 3 and hollow rods 5 drawn through the edges of the wound remain until the last sanitation in the abdominal cavity. When it becomes possible to close the abdominal cavity, the elements of the device are separated, the hollow rods 5 are removed from the tissues. The abdominal cavity is sutured in layers in the traditional way or separation plastic surgery of the abdominal wall defect is performed.

As can be seen from the description and figures, the use of guides for ligatures 2, rigidly connected to the base 1 and supporting elements 3, eliminates the change in the relative position of the thread and the base under load and the cutting of tissues by the ligature. Consequently, the bases are fixed along the edge of the wound with a uniform load distribution between all structural elements both in the superficial and deep layers of the wound.

Claims (3)

1. A device for suturing tissue defects, containing a base on which at least one support element is located, in which a hollow rod is fixed, characterized in that the device contains a second base identical to the first, with located on it at least one support element with a hollow rod fixed in it, the bases are made in the form of a plate with holes, each support element is made in the form of a disk with a groove; on one side there is a platform with a hole for attaching to the support element, inside the hollow rod there is a stylet with a hole for a ligature, the stylet has a platform for holding it with a needle holder, and the hole for the ligature is located on the cutting part of the stylet. 2. The device according to claim 1, characterized in that the supporting element is made with holes. 3. The device according to claim 1, characterized in that the hollow rod is fixed with a wing screw and washer.

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