Thread suture endoscopic device

Abstract

A suturing device for endoscopic applications comprising a proximal end and a distal end, the distal end comprising a clamp (3) formed by two opposing blades (3a, 3b) intended to accommodate a suturing needle (9), the proximal end comprising a control mechanism for opening and closing the clamp, deflecting the needle and passing the needle from one blade to the other of the clamps (1, 2a, 2b). Thanks to the deflection of the needle it is possible to use much larger needles than in the current state of the art.

Description

[Technical field]

[0001] The present invention is in the field of medical-surgical instruments, and more particularly in the field of flexible endoscopic devices.The present invention refers to a device for performing simple or continuous suturing of lesions or perforations, performed from within the organ, applicable to all layers of the walls of hollow body organs, such as all layers of the walls of the digestive tract. [Background technology]

[0002] Endoscopic procedures for the diagnosis and treatment of gastrointestinal pathologies of the biliary system, vascular system and other organs of the human body are developing to become common procedures in all hospitals and medical centers. Gastrointestinal endoscopy is a diagnostic-surgical technique carried out through the natural orifices of the gastrointestinal system, mouth or anus, with the aid of flexible endoscopes of different characteristics and lengths, equipped with a light source, a video camera and a working channel of less than 5 mm into which different tools can be inserted. All this allows the medical team the intravascular diagnosis of pathologies and their treatment. These techniques are known as minimally invasive, since they avoid major interventions and therefore allow for a shorter and more comfortable recovery period for the patient, with much fewer comorbidities, and even no scars, since no incisions are made in the skin.

[0003] Endoscopic treatment of lesions currently covers various techniques such as electrocautery, laser photocoagulation, hyperthermia by application of thermal probes, sclerotherapy, or resection, using either hot or cold loops to perform polypectomies or mucosectomies, or elastic bands to perform mucosectomies and small submucosal resections. On the other hand, knives developed in recent years make it possible to perform wider or deeper resections, and in recent years even complete resections of the gastrointestinal wall. However, this great advance in resection techniques has not been accompanied by sufficient advances in techniques to close scars or defects in the wall. Thus, the practical possibilities of the aforementioned techniques are limited. In many cases, hemostatic clips of various sizes are used to a greater or lesser extent, or preformed knots that can be closed remotely, known as "endoloops", are very useful for pedunculated lesions or in combination with hemostatic clips. However, these conventional systems are not sufficient to completely close the wall. For this reason, new forms of approximation are being investigated, either with techniques combined with laparoscopy to determine the need for surgical intervention, or with devices that close the lesion before cutting it, which, due to their design, limit the size of the lesion to about 2 cm. Finally, some suturing systems have emerged that, although useful, have several limitations that must be overcome. The most prominent is that described in US Patent Application Publication No. 2012 / 0157765 A1, which has significant constraints on mobility due to the need to use a cap with a needle at the distal end of the endoscope (the end furthest from the operator / endoscopist), which limits flexibility and vision, making it practically impossible to use it in the right colon (cecum, ascending colon, or transverse colon), as well as requiring a dual-channel endoscope and complex manipulations by the endoscopist and assistant, limiting its widespread use. Other systems currently being tested allow their use through endoscopes with a single working channel, but still require the placement of a cap to carry the needle.In addition, these suturing systems only allow one suture to be applied and if it is to be used again the entire device must be changed.

[0004] In recent years, various devices have been developed that attempt to solve this problem by using only the working channel to perform the sutures, eliminating the need for overtubes, caps, or materials running outside the endoscope. Among these devices, the one described in EP 3357432 A2 stands out, but it faces great difficulties in terms of its applicability due to the size of the working channel (less than half a centimeter), the need for great flexibility to pass through the angles of the digestive tract, and the necessary manipulation of the device far from the effector area, the conditions of the device, especially the size of the needle, which must be less than 2 mm in its long axis, which limits the strength of the sutures, the efficiency and reliability when performing the sutures, and therefore also the size of the treatable area. Summary of the Invention

[0005] The object of the present invention is to provide a flexible endoscopic suturing accessory, which allows an easy approach to the lesion, wound or perforation (intentional or accidental), with unlimited maneuverability and flexibility, allowing the loops of up to 360° to be overcome, generated by the endoscope during endoscopic exploration, even with a length of 2 m, simple operation for its external handling, and the use of the accessory through a single working channel of less than 5 mm as described above. In addition, the accessory of the present invention is not constrained by the size or physical characteristics of the lesion when working on the treatment, since it allows easy recharging without removing the endoscope and there is no need to use a needle cap. It also solves the problem derived from the channel work size, allowing a suture needle with a length twice that of the channel size, and thanks to the change in the mechanism, also facilitates an increase in the thickness of the needle, allowing an increase in the tension held during the closure of the lesion.

[0006] The present invention solves the above problem thanks to its ability to change the alignment of the needle from a position parallel to the longitudinal axis to a position transverse to said axis. To achieve this objective, the present invention proposes a suturing device for endoscopic applications, comprising a first distal end (intended to support the needle and therefore the end furthest from the operator) and a proximal end (intended to support a control device for handling the needle). At the proximal end of the device there is a control mechanism comprising sliding tabs and metal cables, which comprise different materials, such as Nitinol, steel, iron, matching the characteristics of flexibility and hardness in their longitudinal axis. These cables are attached to a distal clamp and a needle clamping mechanism within the distal clamp. Thanks to the use of these tabs, which open and close the clamp through the cables, together with the needle clamping mechanism, it is possible to change the orientation of the latter so that when the closed device is inserted inside the patient, the needles are parallel to the main axis of the device and are placed in a transverse position when they are in position to start a stitch, and then proceed from one blade of the clamp to the other.

[0007] More specifically, the invention is a suturing device for endoscopic applications, comprising a proximal end and a distal end, the distal end comprising a clamp formed by two opposing blades intended to accommodate a suturing needle, and the proximal end comprising a control mechanism for opening and closing said clamp, changing the orientation of the needle and its passage from one blade to the other of said clamp. To hold the needle, each blade has a guillotine that slides on it and a hole that accommodates the outside of the needle, so that the cooperation between the guillotine and the hole makes it possible to hold the needle and change it from one blade to another. Optional aspects of the invention are defined in the dependent claims.

[0008] To supplement the specification under construction and to facilitate a better understanding of the features of the invention, a set of drawings are attached as an integral part thereof, in which are shown, by way of example and non-limiting nature: [Brief description of the drawings]

[0009] [Figure 1] Shown is a general and schematic view of the device where both ends of the device can be seen. [Diagram 2] FIG. 1 shows a general and schematic view of the device of the invention with the opening and closing system open and the needle in a lateral position. [Diagram 3] 1 shows a needle suitable for use in the present invention. [Figure 4] The distal end, i.e., the end closest to the lesion, is shown, as well as the different steps of opening, closing and redirecting the needle to apply the stitch. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] Preferred embodiments of the invention will now be described in detail, and not in a limiting manner.

[0011] As can be seen in Figure 1, the device is composed of two well-differentiated ends, namely the proximal end closer to the operator and the distal end where the needle is located, separated from each other by a sufficient length (between 180 and 240 cm) that allows its use in gastroscopes and colonoscopes. The main feature of the invention is that it allows the change of the alignment of the needle from a position parallel to the blade of the clamp to other lateral positions. Thanks to this system, enough space is left for the size of the needle, which reaches a length of 5-7 mm and a thickness of 0.4-0.8 mm on the longitudinal axis, substantially larger than that of the needles of the state of the art, allowing greater control and less errors in the exchanges within the stitches, allowing greater tensions and stitches in deeper or fibrotic tissues. It also allows to maintain its mobility and flexibility in the longitudinal axis.

[0012] At the proximal end (the end closest to the user and furthest from the lesion) are the controls for operating the device. This end preferably comprises a tubular body with a cylindrical or rectangular section, made of plastic material. Neither the diameter nor the shape of this body is limited by the space of the working channel of the endoscope, since this end never enters the endoscope. Its measurements can therefore vary between 3 and 7 cm transverse diameter and between 10 and 25 cm longitudinal diameter, depending on the comfort of the operator. A series of sliding tabs move on this body, namely tab (1) that controls the opening of the clamp (3) and two tabs (2a, 2b) that control the portability mechanism and clamping of the needle from one blade of the clamp to the other, which, when moving the cable proximally or distally, preferably pull or push metal, which transmits the movement towards the distal end, avoiding deformation phenomena typical of plastic materials. As the tab (1) moves towards the distal end, the blades separate and thus clamp (3) opens. As the operator pulls towards the proximal end, clamp (1) closes, bringing the two blades closer together. As the tab (1) moves towards the distal end, clamp (1) closes, bringing the two blades closer together. As the tab (1) moves towards the distal end, clamp (1) closes, bringing the two blades closer together. As the tab (1) moves towards the distal end, the blades separate and thus clamp (3) opens. As the operator pulls towards the proximal end, clamp (1) closes, bringing the two blades closer together.

[0013] The needle clamping and portability mechanism includes two sliding tabs (2a, 2b), each with a distinct cable and independently controlling the guillotine (4a, 4b) to move it over the blade, thus leaving the needle free or fixed to the corresponding blade. In one embodiment, these mechanisms are equipped with stops, ledges or locks that activate when the guillotine is in the clamped position preventing its involuntary opening, relieving the operator from the burden of continuously applying a closing force. In another implementation, these mechanisms of clamping opening and clamping and needle portability can be separated into two independent bodies. Because, thanks to the fact that the size of the proximal end is not limited, it is possible to have two cylindrical bodies, each body carrying one of the mechanisms and connected with its working mechanism by a corresponding metal cable, so that they can be controlled by two operators (e.g., a doctor and an assistant). These bodies are later joined in a cylindrical body that connects the proximal ends.

[0014] The proximal part of the cylindrical body incorporates a hollow circumferential area (10) having a diameter of at least 3 cm, into which the operator preferably, but not necessarily, inserts his thumb in the manner of conventional endoscopic devices to provide stability to the device and precision in operation. The end opposite the distal part of the device is tapered to provide a transition between the proximal part where the control mechanisms are located and the proximal part intended to be inserted into the working channel of the endoscope and typically having a diameter of less than 4 mm. In this conical region come together the metal cables that transmit the movements generated in the control device.

[0015] The union between the proximal and distal ends is made by a metal cable that may be covered with a plastic material, PVC, polypropylene, silicone, to reduce the resistance between the cables and to group all the metal cables in a single tubular section.

[0016] To perform the suturing, a nylon thread, a biocompatible material or a metal compound is fixed to the needle. The fixation of the thread can be done in a central area (8) (hole or area for gluing the suture, FIG. 3). Optionally, the body (9) can have a coil that collects the suture. The coil can have a self-tensioning system that allows the thread to always have a certain tension and prevents the thread from tangling with the movement of the endoscope.

[0017] A diagram of the clamp (3) and the parts that make up the clamp, namely the blades and the cylindrical support (5), can be seen. The blades are two equal structures facing each other and supporting the needle. They are each composed of a body differentiated in two flat segments, perpendicular to each other. Both blades are attached to the cylindrical support (5) in the form of an X and share an axis passing through said support. Each blade is attached at its proximal end to a metal cable, these cables being attached to a sliding drive tab (1). As the blades are arranged in an X shape and can rotate around an axis passing through the support, the clamp (3) can be opened and closed with a single movement of the drive tab (1).

[0018] The cylindrical support (5) is attached to the tubular body and has a cylindrical proximal part that allows the passage of a cable to control the opening and closing of the clamp. In an initial configuration, it can have a specific hole for this, but in an alternative configuration, it can be arranged in a single larger hole. At the end that is attached to the blades, it is U-shaped to allow them to rotate.

[0019] As can be seen in Figure 2, the guillotine (4a, 4b) is moved from the outside over the distal segment of the blade. The guillotine is attached to the outside of the segment by a rail system that holds both pieces together but allows movement along the segment when metal cables controlled by sliding tabs are activated. On the inner part of this segment, both blades have a thinner rail in which the needle is housed upon introduction through the working channel of the endoscope before changing direction and positioning for suturing.

[0020] With reference to Figure 2, the device can be seen once the needle (5) is placed in a lateral position and fixed by the guillotine of the left blade (4a) with the corresponding sliding tab (2a) displaced. In this view, the thread for redirection (6) is no longer visible, because once the needle is positioned, it is withdrawn to avoid interference with the suture. In this view, the clamp (3) is seen in the open position.

[0021] To change the orientation of the needle, in one implementation there is a round-trip thread (6) that passes through a specific hole in the needle and then through a hole in one of the blades of the clamp, so as to run externally through the device. Said thread is controlled at the proximal end. The thread, preferably nylon, starts at the proximal end of the device, goes through the body (on the outside in the figure, but it can also be inside the body itself, parallel to the metal cable of the clamp opening and holding system and the portability of the needle), then goes through a hole in one of the blades of the clamp, and returns to the proximal end of the device through a lateral hole (7) of the needle (12). By pulling both ends of the thread (6) simultaneously, the needle changes its orientation and is inserted into the blade through the holes (12a, 12b), thus staying laterally. Once in this position, the clamp mechanism is activated; i.e. the guillotine of the corresponding blade (4a or 4b) slides through the corresponding sliding tab (2a, 2b), thus fixing the needle to the blade. Once secured, the thread (6) is withdrawn by pulling on one of the running thread ends to release the needle from the system, freeing the needle so that it does not interfere with subsequent suturing.

[0022] There are any number of other ways to effect this change in orientation, among which stand out by way of suggestion, but not by way of limitation, the introduction of ferrous material into one of the ends of the needle and magnetization of one of the blades, so that when the blades are released they are positioned by magnetic attraction in a lateral position similar to the screws in a magnetized screwdriver.

[0023] At the distal part of this segment there is a hole for the passage of the needle (12). This hole has the appropriate size for the passage of the needle, which in the preferred embodiment is 0.6 mm. At the distal end of the blade there is a blade stop (13), which is thicker than the rest, which is the thickness of the blade plus the guillotine. The function of the stop is to allow the guillotine to apply pressure against it to keep the needle in place. It preferably has a rounded and polished edge, which facilitates insertion through the working channel and reduces wear that may occur from rubbing against the tissue when making the suture.

[0024] In another embodiment, the stop (13) is provided with a hole in the upper part to introduce a stylet, which complements the guillotine and passes a needle through the hole to improve fixation at the exact point.

[0025] In another possible implementation, the stop (13) of the blade has a base so that the guillotine can cut the thread in a configuration such that the needle repositioning thread is cut without being pulled out.

[0026] Thus, the needle (9) is configured in a cylindrical body, in the preferred embodiment (Fig. 3), beveled and conical at both ends, with lateral guide recesses or recesses as shown. Because stitches are performed in both directions, the suture thread is attached to the same central point (8), which in the preferred embodiment is represented as a hole. Because the thread can be knotted, affixed, or joined in any manner considered part of the state of the art. The thread can be made of biocompatible materials, nylon, metal, biodegradable, etc.

[0027] Similarly, the needle has a hole (7) on one of the sides prior to the angled area through which the thread (6) responsible for the change of direction passes. The needle can have a narrow area on each side (11) (prior to the angled area) as a neck so that the guillotine can use that area as a fixed point when making the stitch.

[0028] In Figure 4 the suturing process can be seen diagrammatically separated into different steps for better understanding.

[0029] The first step (Figure 4a) consists of introducing the present invention through the working channel of the endoscope in the closed position (which appears slightly open in the figure to allow a better understanding of the relative positions of the needle and blade).

[0030] The second step (4b) consists in opening the blades. To do this, the tabs of the clamp opening system (1) are moved towards the distal end. The tabs move the two cables equally towards the distal end. As the cables are attached to the blades, they rotate on their axis. At this same moment, a change of orientation of the needle (9) is made from a position parallel to the blades to a lateral position. To do this, in a preferred configuration, both ends of the wire (6) are pulled, so that the wire (6) starts from the proximal end of the operator and passes through one of the holes (12a) in one of the blades, and then through a specific hole in the needle (7) until the needle is lateral to the device.

[0031] In a third step (4c), the needles are fixed or secured to the guillotines (4a, 4b) by the control tabs of the clamping mechanisms (2a, 2b). The operator moves one tab or the other, respectively, and each tab is connected to an independent cable for each guillotine. Once the needles are fixed in place, the suture is placed.

[0032] In the fourth, fifth and sixth steps (4d, 4e, 4f) the needle can be seen after being advanced from one blade to the other, the opening and closing action of the clamp (3) is done using tab (1) and the control tabs (2a, 2b) must be toggled to move the trimmer to lock or unlock the needle in a controlled manner. These steps can be repeated as many times as necessary to achieve the desired suturing.

[0033] The needle is then released, which remains inside the body with the thread, which starts from the needle and runs through each of the stitches made. A knot can be made at the end, or the system can be crimped, either through a cannula introducing a fastener, or through a system known for stitching.

[0034] In view of this description and the drawings, those skilled in the art will appreciate that although the present invention has been described according to certain preferred embodiments thereof, variations can be introduced in said preferred embodiments without departing from the scope of the invention as claimed.

Claims

1. 1. A suture flexible device for endoscopic applications, comprising a proximal end and a distal end, the distal end comprises a clamp formed by two opposing blades intended to receive a suture needle in a position parallel to the main axis of the suture flexible device, the proximal end comprises a control mechanism for opening and closing the clamp, for redirecting the needle to a lateral position and for passing the needle from one blade to the other of the clamp, each blade comprising a guillotine adapted to slide on the blade and a corresponding blade hole, such that when the needle redirects its orientation to a lateral orientation, the needle is fixed by the guillotine and the corresponding hole, Thread suture flexible device.

2. 2. The suture flexible device of claim 1, wherein the control mechanism is a first metal cable adapted to open and close the clamp, and a second metal cable attached to a corresponding slide tab to move a corresponding guillotine on its blade.

3. 3. The thread suture flexible device of claim 1 or 2, further comprising a thread associated with said suture needle for changing the orientation of said needle.

4. The suture flexible device according to any one of claims 1 to 3, characterized in that the guillotine is provided with a cutting edge.

5. A suture flexible device according to any one of claims 1 to 4, characterised in that each blade is provided with a stop at its distal end.

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