Dynamic abdominal wall traction system for open abdominal wounds

Abstract

The present invention relates to a dynamic abdominal wall (AW) traction system for an open abdominal (OA) wound, which system is temporarily connectable to the OA wound to achieve stepwise and controlled closure. The system comprises: an elastic ring (1) connectable near the edge of the OA; the pull wire (2) is interwoven between the rings (1) in a zigzag shape; a traction element (3) for applying a variable and controllable traction force to the traction wire (2) and the loop (1); and a retaining element (4) connectable by suturing to the inner edge of the AW and to each ring (1) such that the rings (1) and the OA wound are indirectly engaged by sutures for connecting the respective elements.

Description

[0001] Purpose of the Invention

[0002] The present invention relates to the technical field of devices for closing wounds and clamps for wounds, and in particular to a dynamic wall traction system for open abdominal wounds. Background Art

[0003] In cases where surgical intervention within the abdominal cavity requires percutaneous incision to gain access, primary closure of the abdominal cavity restores the structure and physiology of the abdominal wall, thereby providing protection for the abdominal contents and reducing surgical wound complications. However, there are some situations that may lead to abdominal compartment syndrome (ACS) (e.g., polytrauma, severe septic abdomen, severe acute pancreatitis) in which primary closure is not possible and temporary abdominal closure (TAC) is performed to allow for subsequent intervention.

[0004] Forced closure of the abdominal cavity can lead to an increase in the patient's intra-abdominal pressure (IAP), potentially leading to the aforementioned ACS, a condition characterized by increased pressure in the abdominal cavity. This results in abnormal venous return and impaired blood supply or perfusion to the abdominal and retroperitoneal organs (such as the kidneys), causing reduced perfusion that can lead to organ failure and death of the patient.

[0005] Over the years, various strategies have been developed to reduce intra-abdominal hypertension and prevent its progression to ACS. Monitoring of IAP is key to early detection of ACS. Early detection enables rapid treatment, initially using minimally invasive procedures, and if ineffective, surgical decompression with open abdomen (OA) is required.

[0006] Currently, known methods for treating ACS are vacuum-assisted closure (VAC), in particular the "ABThera" system, which performs negative pressure therapy (NPT OA) on the open abdomen. This method is indicated for temporary management of the open abdomen when primary closure is not possible and / or when multiple abdominal re-interventions are required.

[0007] Among the many therapeutic benefits provided by this system, it is noteworthy that it delivers uniform tension, reduces lateral deviation and retraction of the abdominal wall, and is useful for achieving primary closure. However, as previously mentioned, primary closure is not always possible, and therefore it is important to obtain the safest possible closure of the abdominal wall.

[0008] Furthermore, a number of complications can arise during the treatment of patients with an open abdomen, related to the intra-abdominal problems that led to this management. Planning for safe closure begins immediately after the abdomen is opened, as definitive closure of the abdominal wall is difficult to achieve in a large proportion of patients, many of whom eventually develop ventral hernias or require secondary healing of the abdominal wall, which is difficult and expensive to treat.

[0009] To address these issues and avoid a larger abdominal defect due to delayed closure, techniques such as polypropylene mesh wall traction can be used. However, the disadvantage of this method is that the suture is to the aponeurosis, and the suture line compromises 2 cm of the aponeurosis on each side, making final closure more difficult. In addition, the tension cannot be adjusted during treatment without surgery on the patient.

[0010] In the prior art, there are commercial devices developed by Southmedic such as the "ABRA-Abdominal Wall Closure System". This system uses a set of tensioners or elastics placed perpendicular to the incision, which are completely passed through the thickness of the patient's abdominal wall from the skin to the inside of the wall or peritoneum. These tensioners have retainers on the skin that are gradually tightened over a few days, gradually bringing the edges of the abdominal wall closer together. The tension in the elastic is adjusted from one to another until complete closure is achieved, but this process is very labor-intensive during NPT.

[0011] The ABRA system is very expensive and complex, and is highly invasive for the patient as it produces a significant inflammatory response within the first 24 to 48 hours, as well as abdominal wall necrosis, ulceration, and scarring, leaving sequelae on the skin. There are also some problems when used with NPT AA because the system consists of a thick non-porous silicone membrane, which means that its surface does not have any discontinuities. This interferes with NPT in the open abdomen, preventing the NPT from passing to the peritoneal surface and draining fluid from the viscera by NPT suction, thereby failing to achieve the therapeutic purpose of the open abdomen. In addition, the elastomeric traction system of ABRA does not allow good access to the abdominal cavity during re-intervention to address the cause of the open abdomen and perform dressing changes.

[0012] Patent document WO2018109253 owned by the present applicant discloses the inventor's previous development, which comprises a dynamic wall traction device for gradual closure of an open abdomen, which is intended to address the above-mentioned disadvantages.

[0013] The device comprises two sheets or layered bodies made of a fenestrated material attached to the abdominal wall. Each body has a plurality of through holes through which a traction line can pull the two bodies, thereby achieving a gradual closure of the abdominal cavity. Although the device improves the passage of fluids in an open abdomen by NPT suction, there is still a need to simplify and optimize the gradual closure of an open abdomen and the use of NPT.

[0014] Document US2008306496A1 relates to a device and method for closing the abdomen between surgical operations and maintaining the normal physiological tension of the fascia to prevent improper retraction. The document proposes the use of several closing devices, each of which includes a pair of "needle-shaped hook and loop (needle-shaped carabiner) elements connected to the ends of a specific tensioning device (such as an elastic band with a specific tension).

[0015] This system, like ABRA, is very complex, since it requires four to eight closure devices, depending on the length of the abdominal incision, which complicates the necessary reinterventions in this type of treatment. In addition, due to the rigid nature of the fixation ring (which is temporarily attached to the fascial edge when the abdominal wall is opened), complications may arise due to pressure on adjacent intra-abdominal viscera, since the document does not describe its use in an open abdomen with the NPT device, which uses a visceral protection sheet.

[0016] Document EP1982656A1 discloses a system and method for accessing tissue by attaching anchors that are difficult to fix without a large amount of tissue and making extensive exposure of the anterior abdominal aponeurosis on opposite sides of the wound and coupling the anchors together.

[0017] This procedure, which exposes the aponeurosis or fascia, increases morbidity and offers no clear advantage. The intended use of progressive closure of an open abdomen in conjunction with NPT is not specified and, like the ABRA system or the device described in US2008306496A1, it is a fairly complex system that complicates reintervention of the abdominal cavity and the use of NPT.

[0018] Finally, document WO2014125148A1 discloses a kit of elements specifically designed for performing closure surgery after abdominal surgery in patients for whom direct primary suturing is not possible with laparotomy.

[0019] The kit comprises an elastic strip attached to an anchor which is fixed to the skin of the wound, meaning that the closure is not effective in pulling the whole abdominal wall and the elastic strip may adhere to the adhesive patch of the NPT, preventing it from performing its function.

[0020] Therefore, there is a need for a device or system that can dynamically traction the walls of an OA wound and overcome the shortcomings associated with current solutions in the prior art. Summary of the invention

[0021] The object of the present invention is a dynamic abdominal wall traction system for open abdominal wounds which avoids the aforementioned drawbacks and also prevents aponeurotic retraction from the beginning of the open abdominal treatment, thus allowing safe correction of the abdominal defect at the end of the NPTOA.

[0022] Compared to what is disclosed in application WO2018109253 of the same applicant, although the device therein improves the passage of fluids by suction of the NPT OA, the system proposed here simplifies and optimizes the gradual closure of the open abdomen (OA) and the use of the NPT.

[0023] The system is intended to be positioned within an open abdomen and consists primarily of:

[0024] - at least two retaining elements;

[0025] - an elastic ring through which the traction wire is inserted; and

[0026] - A traction element connected to the traction line.

[0027] The holding element is designed to be sutured near two opposite edges of the open abdomen, more specifically the inner or peritoneal edge of the abdominal wall. In a preferred embodiment of the system, each holding element is positioned on the inner wall of the wound, 3 cm to 4 cm from the corresponding upper aponeurotic edge of the abdominal wall.

[0028] Each retaining element is formed by a substantially flat and elongated part, which comprises an upper section, a lower section, and a transverse notch defined in two opposite regions of the peripheral edge, which separates the two sections. In the upper section, there is a through hole at the top and a through slot at the bottom, which extends continuously from the through hole toward the lower section.

[0029] The suture (whether thread, tape or the like) connecting the retaining element to the edge of the abdominal wall is passed through the through slot and then slid into the through hole, which holds the suture in place with its loop in. This prevents lateral movement of the retaining element, ensuring that it remains properly connected to the inside of the abdominal wall.

[0030] The elastic rings are positioned in pairs on two opposite edges of the open abdomen. Each elastic ring is also connected to a corresponding retaining element by a suture.

[0031] In this way, the elastic rings are not directly connected to the aponeurotic edges of the open abdomen, but are connected to the body structure through the corresponding retaining elements connected thereto. The sutures connecting each ring to its retaining element pass through the aponeurotic edges and out from the upper edge of the aponeurotic edges to engage the elastic rings, thereby preventing interference with the aponeurotic edges and avoiding damage or injury.

[0032] This is one of the main advantages of the system. The holding element allows the traction for closing the open abdomen to be preferably performed from the medial (peritoneal) edge of the abdominal wall, thereby pulling the aponeurotic / muscular structure of the abdominal wall toward the midline. Thus, by tensioning or pulling the entire abdominal wall structure, an "upward" traction of the aponeurotica is created, reaching the midline of the open abdomen in an anatomically appropriate manner through the vector.

[0033] The resulting tension-traction vector is more favorable than that of the ABRA system, in which the wall is pulled "down" from the skin to the peritoneum, and the traction does not pull or prevent retraction of the wall in an appropriate manner. In addition to the complications of the subcutaneous tissue and skin described previously, by being positioned 3 or 4 cm from the aponeurotic edge, this system avoids damage to the aponeurotic edge, leaving it intact and well vascularized for primary closure at the end of an open abdominal procedure. This is not the case with mesh sutured to the aponeurotic edge or with the ABRA system, which may interfere with vascularization by pulling on the entire wall.

[0034] Finally, a traction line or band is passed between the rings and interwoven in a zigzag pattern between the opposing elastic rings, allowing the application of a variable traction force that gradually approaches the two sides of the open abdomen to achieve its closure, pulling on the ring and, therefore, the aponeurotic edges to which it is attached.

[0035] Each traction wire comprises a free end connected to a single traction element, so that a variable and controllable traction force can be applied.In a preferred embodiment of the system, the traction element consists of a manually operable tourniquet.

[0036] In an alternative embodiment, the system comprises a plurality of additional elastic rings connected to each main elastic ring and having different diameters and tensions. These additional rings are able to gradually increase the tension and reduce the elasticity of the system by applying a force from the traction element.

[0037] A dynamic wall traction system for open abdominal wounds provides a simple solution that overcomes the shortcomings of the prior art. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] In order to supplement the description and help better understand the features of the present invention, according to the preferred embodiment of the present invention, a set of drawings is included as an integral part of this specification, in which the following are shown in an illustrative but not limiting manner:

[0039] Figure 1 A perspective view of a dynamic traction system applied to an open abdomen is shown.

[0040] Figure 2 A perspective view of a retaining element of the system is shown.

[0041] Figure 3 The connection between the ring and the retaining element of the system and its arrangement in an open abdomen are schematically shown. DETAILED DESCRIPTION

[0042] Preferred embodiments of the subject matter of the invention are described in detail below with reference to the aforementioned drawings.

[0043] The dynamic wall traction system for open abdominal wounds is intended to be temporarily sutured to an open abdominal (hereinafter also referred to as OA) wound to facilitate gradual and controlled closure.

[0044] To achieve this purpose, the system mainly comprises: elastic rings (1) arranged on two opposite edges of the OA, a traction line (2) passing through the rings (1), a traction element (3) that can be connected to the traction line (2), and a retaining element (4) that can be connected to the rings (1) and the inner edge of the OA in turn. Figure 1 Displays the system applied to OA.

[0045] The rings (1) are arranged in pairs towards each other near the outer or aponeurotic edge of the OA. Each ring (1) is connected to a corresponding retaining element (4) by sutures.

[0046] The traction wire (2) passes through the interior of the rings (1) and is interwoven in a zigzag pattern between the opposing pairs of rings (1), allowing the application of a variable traction force that brings the rings (1) and therefore the edges closer together, thereby facilitating the gradual closure of the open abdomen.

[0047] Each traction wire (2) has a free end connectable to a traction element (3). The traction element (3) allows a variable and controllable traction force to be applied to the traction wire (2) and thus to the ring (1). In the preferred embodiment shown, the traction element (3) consists of a manually operable tourniquet. In an alternative embodiment of the system, the traction element consists of a micron closure.

[0048] Figure 2 One of the retaining elements (4) used in the system is shown in detail. As previously described, each retaining element (4) is sutured near two opposite edges of the open abdomen, specifically the inner or peritoneal edges of the abdominal wall (PE). In a preferred embodiment of the system, each retaining element (4) is placed at a distance between 3 cm and 4 cm from the corresponding aponeurotic edge (AE) of the abdominal wall (AW), such as Figure 1 and Figure 3 shown.

[0049] Each retaining element (4) is formed by a substantially flat and elongated part, shaped like a beveled plate, comprising an upper section (5), a lower section (6), and a transverse notch (7) defined at two opposite regions of the peripheral edge, the transverse notch (7) separating the two sections (5, 6). The upper section (5) comprises an upper through hole (8) and a lower through slot (9), the lower through slot starting from the through hole (8) and extending towards the lower section (6).

[0050] The sutures connecting the retaining element (4) to the inside of the abdominal wall (AW) are passed through the lower through slots (9) and then slid upwards to the through holes (8) which retain the sutures by their annular ends. This prevents the retaining element (4) from lateral displacement, ensuring its proper attachment to the abdominal wall (AW).

[0051] The same sutures of the retaining elements (4) pass through the aponeurosis and come out from the upper edge of the aponeurosis to connect with the corresponding ring (1). This design avoids direct connection of the ring (1) to the aponeurosis edge (AE), thus preventing any damage or injury. Figure 3 This connection between the ring (1) and the retaining element (4) is shown schematically.

[0052] In an alternative embodiment not shown in the drawings, the system comprises a plurality of additional elastic rings, each of which is connected to one of the main elastic rings (1) and has a different diameter size and tension level. The additional rings can gradually increase the tension and reduce the elasticity of the system by applying a force from the traction element (3).

Claims

1. A dynamic abdominal wall traction system for an open abdominal wound, the dynamic abdominal wall traction system being capable of being temporarily attached to an open abdominal (OA) wound for gradual and controlled closure, the dynamic abdominal wall traction system comprising: - elastic rings (1) which can be attached near the aponeurotic edge of the OA and are arranged in pairs towards each other at opposite edges of the OA; - traction wires (2) interwoven in a zigzag pattern between the facing pairs of rings (1) and passing through the inside thereof, wherein each of the traction wires (2) has a free end; and - a traction element (3) which can be attached to the free end of the traction line (2) to exert a variable and controllable traction on the traction line (2) and the ring (1); The dynamic traction system is characterized by: - the dynamic traction system further comprises a retaining element (4) which can be attached by suturing to the intraperitoneal edge of the abdominal wall (AW) and to each ring (1); and - The system comprises the same number of said rings (1) as said retaining elements (4), so that the connection between said rings (1) and said OA wound is indirect, through the intervention of sutures connected to the respective retaining elements (4).

2. The dynamic abdominal wall traction system according to claim 1, wherein: Each retaining element (4) is formed by a substantially flat and elongated part in the shape of a beveled plate, and each retaining element (4) comprises: - an upper section (5), said upper section (5) having an upper through hole (8) and a lower through groove (9); - a lower section (6); and - a transverse notch (7) defined in two opposite regions of the peripheral edge of the plate, said transverse notch (7) separating the two sectors (5, 6).

3. The dynamic abdominal wall traction system according to any one of the preceding claims, further comprising a plurality of additional elastic loops linked to each main elastic loop (1).

4. The dynamic abdominal wall traction system according to any one of claims 1 to 3, wherein: The pulling element (3) is a tourniquet that can be manually operated.

5. The dynamic abdominal wall traction system according to any one of claims 1 to 3, wherein: The pulling element (3) is a micron closure.

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