Surgical suture system comprising an improved cap

Abstract

The present invention relates to a surgical suture system comprising an endoscopic cap (100), a needle (200) and a tool for gripping the needle (200) which is axially movable relative to the cap (100), characterised in that the needle (200) is temporarily retained by means (104) for holding the needle (200) in the cap (100), when the gripping tool (300) is in the rear position in a position suitable for gripping by the gripping tool (300), and in that the cap (100) additionally has a means (105) for holding a suture thread (210) fitted on the needle (200).

Description

Surgical suture system including an improved cap Field of invention

[0001] The present invention relates to the field of medical devices for endoscopic surgical suturing, and more particularly by flexible endoscopy.

[0002] Endoscopic surgery is a method of visually exploring the interior of a cavity using optical tubular equipment introduced either through natural body orifices (flexible endoscopy) or through incisions of a few millimeters in the skin (laparoscopy). This method allows the insertion and use of instruments within the body to perform surgical operations. This type of minimally invasive surgery offers many advantages over conventional surgical techniques (reduction of post-operative pain, recovery time and complications, etc.).

[0003] Many miniaturized instruments have been proposed for this purpose, in particular forceps, scissors, electric scalpels, etc. All these miniaturized instruments are designed to be introduced into the body either through small-section trocars (laparoscopy) or through the operating channel of flexible endoscopes.

[0004] In the specific field of endoscopic wound closure, surgeons have various techniques at their disposal. These techniques consist of either placing staples or clips or performing sutures by remotely actuating a needle driving a suture thread. The present invention belongs to this latter family of solutions.

[0005] In the field of conventional (open) surgery, many developments focus on specific needles with optimized tapered tips with a curved shape allowing more precise rotation and usable with a needle holder in order to catch the needle easily regardless of the user's laterality. With the evolution of practices and the appearance of laparoscopy, the problem of the safe introduction of the needle into the patient has arisen. Today, the trocars used to introduce laparoscopic tools have holes large enough to allow the passage of these standard needles and several technical solutions have been developed to bring and catch the needle easily.

[0006] However, regarding flexible endoscopy, the problem remains. Since the working channel of the endoscope has very narrow access, it does not allow the curved needle to pass inside. Thus, the technical problem is to be able to bring the curved needle outside the flexible endoscope without damaging the walls of the gastrointestinal tract. The invention relates more particularly to the family of curved needles adapted to new techniques for suturing in flexible endoscopy. State of the art

[0007] Known in the prior art is patent application US2022225983 describing a camera needle adapter that includes a tube-shaped body having a proximal end, a distal end, a longitudinal axis, and a lumen extending along the longitudinal axis. A centrally located side access opening is formed in an outer wall of the tube-shaped body. A needle attachment channel is formed in the outer wall and extends between the side access opening and the distal end of the tube-shaped body. A curved suture needle is disposed within the needle attachment channel. The needle attachment channel and the curved suture needle extend along an axis that defines an oblique angle with the longitudinal axis of the camera needle adapter. A distally facing viewing device is positioned within the lumen at the proximal end of the tube-shaped body.The side access opening, needle attachment channel, and curved suture needle are located within a field of view of the viewing device.

[0008] Patent application US2020390436 generally relates to apparatus, devices, and methods for increasing force distribution at a tissue-suture interface. In some embodiments, a tissue suturing device may include a deployment device and a plurality of tissue supports deployable from the deployment device to a target tissue. The plurality of tissue supports may each include a central opening for receiving a suture during deployment. Disadvantages of the prior art

[0009] The solutions of the prior art have a significant bulk, partially masking on the one hand the exit of the operating channel in which the needle actuation mechanism is positioned (or any other endoscopic tools that may be necessary for the surgical procedure) and on the other hand limiting the field of vision of the endoscopic camera.

[0010] Furthermore, their use is relatively complex and unusual for the surgeon. First, the suture is performed frontally and not tangentially as is the case in open or laparoscopic surgery. Second, the needle is not free to move but is fixed to the endoscope or device. Finally, prior art solutions require great dexterity from the operator to grasp the needle, which is located in a position far from the operator, and then position and move it to the area to be sutured, without obscuring vision or damaging the walls of the gastrointestinal tract.

[0011] Solution provided by the invention and general principles

[0012] Needles used in open or laparoscopic surgery have already proven their effectiveness and should be suitable for flexible endoscopy. Unfortunately, the main problem is the management of the needle, which must be able to be introduced, delivered, and removed safely despite its large size and curved shape. Insertion and removal of the needle must not cause damage to the tissues of the digestive tract. Currently, there is no satisfactory solution.

[0013] Thus, the present invention, an exemplary embodiment of which will be described in more detail by way of non-limiting example, relates in its most general sense to a surgical suturing system for performing suturing in endoscopy, and more particularly in flexible endoscopy, using standard and known tools in order to reduce purchasing costs, increase ease of use and obtain constant visibility of the procedure. Thus, the use of an endoscopic needle holder and a standard surgical needle, in conjunction with a conventional endoscope, would meet these criteria, making it possible to perform a tangential suture using a free needle controllable in different directions in space - translation and rotation.

[0014] The aim of the present invention is to propose an endoscopic cap:

[0015] (a) enabling a large, curved, standard surgical needle to be delivered and removed atraumatically and safely into the gastrointestinal tract,

[0016] (b) allowing the needle to be caught and delivered / retrieved in a controlled and progressive manner using an endoscopic needle holder,

[0017] c) not limiting the user's visibility.

[0018] An endoscopic cap is an accessory generally composed of 2 parts: A distal part made of hard or soft transparent plastic in contact with the walls of the digestive tract, A proximal part made of soft transparent plastic which allows attachment to the distal end of a flexible endoscope.

[0019] This accessory determines the operating field at the end of the endoscope, which has an operating channel allowing the passage of a needle gripping tool. It allows the tissue to be aspirated if necessary and treated with various tools. Generally, this type of cap is non-functionalized.

[0020] It is intended to equip the distal end of a conventional flexible endoscope in order to complete a needle gripping tool, for example an endoscopic needle holder such as that of the type described in patent application FR3055793, to form a complete endoscopic suture system.

[0021] Thus, to meet these 3 essential functions, the invention relates to a surgical suture system comprising an endoscopic cap, a needle and a tool for gripping said needle, the end of which is axially movable in translation and in rotation relative to said cap, ensuring that the needle is held in a position allowing it to be gripped by the gripping tool, for example a needle holder, extracted from the cap by axial movement of the gripping means and then manipulated when the needle is extracted from the cap, characterized in that: said needle is retained in said cap when said gripping tool is in the rear position, said needle is temporarily retained by two diametrically opposite holding zones of the inner surface of the tubular wall of said endoscopic cap and retains a constant shape regardless of the temperature, unlike a shape memory needle,said needle is pushed back by the gripping tool when said gripping tool is actuated in a position suitable for gripping the needle, said cap furthermore has a means for holding the suture thread engaged on said needle.,

[0022] The needle is not flexible or shape-memory but of the "rigid elastic" type, that is to say made of a material which deforms little and reversibly when subjected to stress on the two arcuate ends of the needle, in the direction of the needle chord, and which returns, whatever the temperature, to its initial shape when the stress ceases. Typically, this is a material such as steel or a steel alloy.

[0023] The endoscopic cap is designed to contain and hold in place a needle, in particular a standard curved surgical needle while protecting the sharp ends thereof, having:A means for temporarily holding the needle which may be formed by one or more grooves inside the cap allowing the needle to be placed and held,A means for holding the suture thread connected to the needle which may be formed by one or more grooves inside or outside the cap allowing the thread to be placed, or by a biocompatible glue,Custom dimensions adapted to the dimensions of the suture,Positioning of the needle in the cap allowing the sharp ends of the needle to be protected and easier to grip.

[0024] Besides the needle injuring the gastrointestinal wall during insertion and removal, another significant risk with endoscopic suturing is losing the needle. Indeed, if the free needle were to be dropped into the stomach or colon, the peristalsis of these organs would make the probability of finding it low. A lost needle presents a serious danger to the patient during its passage through the digestive tract. The fear of losing a needle is one of the reasons why current suturing solutions are mostly fixed to the end of the endoscope. Our unique solution requires the needle to be grasped by the endoscopic needle holder before deployment, the friction of the needle in the endoscopic cap requiring intentional force to deploy it, and above all a controlled progressive deployment of the suture by the endoscopist (safety and efficiency).It is only these mechanisms that allow the endoscopist to perform essential tasks such as releasing the needle and re-gripping it in another way to enable effective suturing without the risk of losing the needle.

[0025] The endoscopic cap is designed so that the position of the needle makes it accessible to the endoscopic needle holder, thus allowing a progressive release of the needle thanks to: The generation of sufficient resistance to hold the needle (no spontaneous release) but allowing active release using an endoscopic needle holder, The generation of sufficient resistance to hold the suture thread (no spontaneous release) but allowing active release using an endoscopic needle holder,

[0026] - This endoscopic cap is designed to allow needle positioning without significantly impeding visibility.

[0027] The invention relates in particular to a surgical suture system having the characteristics set out in claim 1.

[0028] It comprises an endoscopic cap having a tubular wall, a needle and a tool for gripping said needle axially movable relative to said cap. Said gripping tool being capable of being inserted into the lumen of an endoscope and of sliding axially on an axis parallel with the longitudinal axis of said cap. The needle is retained - when said gripping tool is in the rear position - by friction within the two holding zones. The opposite ends of said needle are in a position suitable for gripping by said gripping tool. The cap further has a means for holding a suture thread engaged on the needle.

[0029] The gripping tool may be, for example, an endoscopic needle holder such as that of the type described in patent EP3509503.

[0030] Preferably, said needle is of arcuate shape.

[0031] Advantageously, said means for holding a suture thread can be formed by a housing.

[0032] According to a variant, at least one of said holding zones of said needle is constituted by a longitudinal groove provided on the tubular wall of said endoscopic cap.

[0033] According to another variant, at least one of said holding zones of said needle is constituted by two protruding grooves defining a longitudinal guide groove for the ends of said needle.

[0034] According to another variant, the tubular wall (103) of said cap has two diametrically opposed holding zones.

[0035] Advantageously, said means for holding the suture thread engaged on said needle consists of a peripheral groove formed in the tubular wall of said cap.

[0036] According to another variant, said means for holding the suture thread engaged on said needle is constituted by an annular protuberance formed inside said cap and defining a space for guiding said thread.

[0037] Advantageously, said means for holding the suture thread engaged on said needle is located in a transverse plane passing through the distal end of said friction zone of said needle.

[0038] According to a variant, said means for holding the suture thread engaged on said needle is located in a transverse plane passing through the proximal end of said friction zone of said needle.

[0039] Advantageously, said cap has an angular reference index.

[0040] According to an advantageous embodiment, said cap is made up of one or more functional elements which can be assembled together in order to constitute the invention in its final form.

[0041] Detailed description of a non-limiting example of embodiment of the invention

[0042] The present invention will be described in more detail with reference to non-limiting exemplary embodiments specifying the above-mentioned advantages and considerations. A more particular description of the invention briefly described above:

[0043] represents a front view and a profile view of the invention according to a first embodiment comprising a groove and a proximal groove.

[0044] represents a front view and a profile view of the invention according to a second embodiment comprising two grooves and a proximal groove.

[0045] represents a front view and a profile view of the invention according to a third embodiment comprising two grooves and a distal groove.

[0046] represents a profile view according to several embodiments of the invention concerning the means for holding the suture thread.

[0047] represents a set of views describing the 4 stages of interaction between the invention and the needle gripping tool.

[0048] Detailed description of a first example of implementation

[0049] The invention illustrated by the schematic front view from the distal end and in profile is an endoscopic cap (100) in the form of a hollow truncated cone tube having an opening at each end (101, 102). The proximal end (101) is made of a flexible plastic part (for example silicone or any other material with similar properties) allowing the invention to be fixed to the distal end of a flexible endoscope (1). The diameter and flexibility of this proximal end (101) allow fixing to a wide range of flexible endoscopes (1) available on the market. The flexible endoscope (1) has a camera, an endoscopic light and an operating channel (3) for the passage of endoscopic tools, in particular the needle gripping tool (300), in particular the endoscopic needle holder.

[0050] The distal end of the cap (102) is made of a tubular wall (103) made of a round, transparent hard plastic (e.g., polycarbonate or any other material having similar properties). This tubular wall (103) has a means for temporarily holding (104) a curved surgical needle (200). Depending on the size of the needle (200), the distal end (102) could be smaller, the same size, or larger than the proximal end (101).

[0051] The tubular wall (103) has a housing constituting the temporary holding means (105) of the suture thread (210) attached to said needle (200). The suture thread (210) advantageously has at its distal end a plastic button (203) allowing the initial anchoring of the suture in the tissue to be sutured. Alternatively, the thread can also be held by gluing.

[0052] The holding means (104) of the surgical needle (200) making it possible to hold said surgical needle (200) within the cap (100) until it reaches the desired location in the gastrointestinal tract is constituted in the example illustrated by a longitudinal groove formed on the internal surface of the tubular wall (103). Said surgical needle (200) will then be released into the gastrointestinal tract using the gripping tool (300).

[0053] The holding means (104) of the surgical needle (200) allows it to be held while protecting the walls of the gastrointestinal tract until it is extracted by the needle gripping tool (300). In the embodiment illustrated by the, it is constituted by a single groove (104) extending along the length of the tubular wall (103) of the cap (100), the pointed end (201) of the needle (200) bearing against the internal surface of the tubular wall (103) of the cap (100), substantially in an area diametrically opposite the single groove (104).

[0054] The surgical needle (200) is positioned between the two edges of the longitudinal groove(s) in order to provide a sufficiently strong grip, by dry friction, so that it does not move on its own, simply due to the movement of the distal end of the endoscope (1), but sufficiently weak to allow the needle gripping tool (300) to push the surgical needle (200) by axial movement, in order to deliver it.

[0055] The needle (200) has, according to the example described, an arcuate shape extending over approximately 180°, and is made of a biocompatible material having an elasticity suitable for low deformation when introducing the needle into the cap (100) of an inner section slightly smaller than the chord of the needle passing through the two most distant zones (201, 202), generally the tip (201) and the opposite end (202) having the eye of the needle in which the suture thread (210) is pre-threaded.

[0056] The needle (200) may also have a straight shape, the two ends (201, 202) being engaged in the longitudinal groove(s) (104). Implementation variants

[0057] The holding means (104) of said surgical needle (200) may be made in other forms than a single groove (104) extending along the length of the tubular wall (103) of the cap (100).

[0058] It can be produced as illustrated by two grooves (104) each extending along two diametrically opposite longitudinal generatrices of the tubular wall (103) of the cap (100).

[0059] Whatever the embodiment, the surgical needle (200) is arranged on the longitudinal axis of symmetry of the cap (100) giving it a central position relative to the distal end of the endoscope (1) making it possible not to significantly obstruct the field of vision of the camera and thus the visibility of the endoscopist.

[0060] The position of said surgical needle (200) provides compatibility with different types of endoscopes (1) available on the market. It is possible to apply a rotation of the cap (100) relative to the endoscope (1) by an appropriate angle so that the surgical needle is ideally placed with respect to the operating channel (3) of the endoscope (1).

[0061] Each of its first two embodiments can be further subdivided into two other embodiments in which the longitudinal groove(s) (104) will be arranged on only a portion of the inner surface of the tubular wall (103) of the distal end of the cap (100).

[0062] If the longitudinal groove(s) (104) are arranged over only part of the length of the distal end of the tubular wall (103), this will in particular make it possible to obtain a larger space for the placement of the holding means (105) of the suture thread (210).

[0063] The longitudinal groove(s) (104) of said surgical needle holding means (200) is / are raised relative to the surface of the tubular wall (103). In a first embodiment, the groove(s) (104) is / are represented by an addition of material relative to the surface of the tubular wall (103) of the cap (100). In a second embodiment, the groove(s) (104) is / are formed by a removal of material relative to the surface of the tubular wall (103).

[0064] The longitudinal groove(s) of said holding means (104) of the surgical needle (200) is / are open at its distal end in order to allow the release of said surgical needle (200) into the gastrointestinal tract using the needle gripping tool (300). This gripping tool passes through the working channel (3) of the endoscope (1), then through the cap (100) in order to catch the surgical needle (200) and remove it from its temporary holding means (104) by pushing it towards the gastrointestinal lumen without releasing it.

[0065] The opening at the distal end of the groove (104) has, according to another embodiment, a slope allowing the needle (200) to exit using the gripping tool (300) but also the rehousing of the needle (200) in the opposite direction (with the tips of the needle (201, 202) towards the distal end (102) of the cap (100); i.e. towards the lumen of the gastrointestinal tract). Thus, the tips (201, 202) of the needle (200) are held and protected by the slope so as not to injure the walls of the digestive tract when removing the system.

[0066] According to another embodiment, the opening at the distal end of the groove(s) (104) is widened outwardly - in a V-shape - in order to allow the needle (200) to be directed towards the groove(s) (104) when it is replaced in the cap (100) at the end of the procedure.

[0067] Illustrates the 4 main steps of interaction of the needle gripping tool (300) with the invention. In an initial phase, the endoscope (1) is arranged in the patient's digestive system. The endoscopic cap (100) is arranged at the distal end of the endoscope (1). The surgical needle (200) is arranged in its holding means (104) so ​​that its ends (201, 202) are oriented towards the proximal end (101) of the cap (100), towards the endoscope (1), and the inflection point (204) of its curvature is arranged towards the distal end (102) of the cap (100), towards the intestinal lumen. This position makes it possible to protect the walls of the gastrointestinal tract from possible injuries or perforations that could lead to complications for the patient. In addition, this position allows for easier gripping of the needle by the use described below. The needle gripping tool (300) -egendoscopic needle holder - is arranged inside the working channel (3) of the endoscope (1) in a recessed rear position.

[0068] In a second phase, the distal end of the needle gripping tool (300) - e.g. endoscopic needle holder - arranged inside the working channel (3) of the endoscope (1) is exposed by an axial advance (translation) at the exit of the working channel (3) at the distal end of the endoscope (1). The needle gripping tool (300) is advanced until it contacts the surgical needle (200). The position of said surgical needle (200) makes it possible to obtain an ideal distance between the exit of the working channel (3) at the distal end of the endoscope (1) and the curvature of the surgical needle - where it is caught. As a result, the gripping tool (300) of the surgical needle exiting the working channel (3) can protrude by a sufficient length giving it a certain flexibility.

[0069] In a third step, this flexibility allows the surgical needle gripping tool (300) to deform slightly and thus be deflected upon contact with the surgical needle (200). The jaws of the surgical needle gripping tool are positioned laterally relative to the needle. The deflection of the surgical needle gripping tool (300) causing a stress on the latter, the opening of its jaws allows it to return to its initial position – releasing the stress – and thus to have said surgical needle (200) positioned between its jaws, at the level of the area surrounding the inflection point (204). According to a variant, the holding means (104) of said needle (200) is formed of grooves made of flexible material allowing the surgical needle (200) to also perform a slight lateral movement facilitating the passage / deflection of the needle gripping tool (300).The needle gripping tool (300) is then actuated to close its jaws on said needle (200) allowing it to be held firmly and controlled. The axial translation forward (towards the intestinal lumen) of the gripping tool (300) thus makes it possible to extract the surgical needle (200) from the said longitudinal groove(s) (104) by pushing it towards the distal end (102) of the cap (100), towards the intestinal lumen, making it possible to gradually deliver said surgical needle (200) into the gastrointestinal tract without ever releasing it. The needle gripping tool (300) being actuable in rotation, the surgical needle (200) is itself progressively and precisely controllable in rotation when it is held by the gripping tool (300). Suture thread accommodation

[0070] In one example, the holding means (105) of the suture thread (210) is provided by a groove-shaped housing hollowed out in the internal face of the tubular wall (103) of the cap (100) so as not to increase the diameter thereof. Indeed, the smaller the diameter, the easier the handling of the invention and its passage through the gastrointestinal tract (particularly at the level of the esophagus).

[0071] The means for holding said suture thread (210) is constituted by one or more circular groove(s) (105). Alternatively, the holding can also be achieved by gluing, for example by an adhesive allowing release when traction is exerted on the needle (200).

[0072] In a first embodiment, said circular groove(s) (105) is / are arranged at the distal end (102) of the cap (100) near its opening as illustrated in the. It / they are located in a transverse plane situated at the distal end of the longitudinal groove(s) (104) for holding the surgical needle (200). Thus, the suture thread (210) emerging from one of the pointed ends (202) of said surgical needle (200) will travel through the longitudinal groove(s) (104) allowing the holding of said surgical needle (200) before winding into the circular groove(s) (105). This embodiment makes it possible not to increase the length of the invention and therefore to improve the visibility of the endoscopist.

[0073] In another embodiment, said circular groove(s) (105) is / are arranged at the proximal end (101) of the tubular wall (103) of the cap (100); it / they are therefore located upstream of the longitudinal groove(s) (104).

[0074] According to an embodiment illustrated by the circular groove(s) (105) for holding the suture thread is / are in relief relative to the surface of the tubular wall (103) of the cap (100). In another embodiment, the circular groove(s) (105) is / are represented by an addition of material in the form of a crown relative to the surface of the tubular wall (103) of the cap (100).

[0075] In another embodiment illustrated by the, the circular groove(s) (105) is / are represented by a removal of material from the surface of the tubular wall (103) of the invention forming a narrow slot in the thickness of the tubular wall (103) of the cap (100). This embodiment makes it possible not to reduce the field of vision of the endoscopist by not adding an additional thickness to that of the tubular wall (103) of the cap (100).

[0076] The circular groove(s) (105) for holding the suture thread (210) is / are arranged over the entire circumference of the invention parallel to the tubular wall (103) of the invention in order to allow the entire length of the thread to be stored without obstructing the endoscopist's visibility or the passage of tools.

[0077] According to an alternative, the holding zones (105) of the suture thread (210) are not continuous but constituted by a succession of holding segments.

[0078] The thread can be held in place by temporary bonding, which cannot withstand traction exerted by the operator or by friction in the groove.

[0079] The circular groove(s) (105) of said suture thread holding means is / are open at its distal end to allow the release of the suture thread into the gastrointestinal tract when said surgical needle (200) is removed from its holding means (104) by said endoscopic needle holder (300).

[0080] The circular groove(s) (105) of said suture thread holding means can accommodate said suture thread (210) wound several times as well as a plastic button (203) arranged at its distal end. This plastic button (203) makes it possible to anchor the suture thread (210) at the start of the suture.

Claims

Surgical suture system comprising an endoscopic cap (100) having a tubular wall (103), a needle (200) and a gripping tool (300) for said needle (200) axially movable relative to said cap (100), said tool being capable of being inserted into the lumen of an endoscope and of sliding axially on an axis parallel with the longitudinal axis of said cap, characterized in that said needle (200) is temporarily retained by a holding means (104) for said needle (200) in said cap (100), when said gripping tool (300) is in the rear position in a position suitable for gripping, and in that said cap (100) further having a holding means (105) for a suture thread (210) engaged on said needle (200). Surgical suture system according to claim 1 characterized in that said needle (200) is of arcuate shape. Surgical suture system according to claim 1 characterized in that said means (105) for holding a suture thread (210) is formed by a housing. Surgical suture system according to claim 1 characterized in that the maintenance of said needle (200) is ensured by a longitudinal groove provided on said tubular wall (103) of said endoscopic cap (100). Surgical suture system according to claim 1 characterized in that the tubular wall (103) of said cap has two diametrically opposed holding zones (104) of said needle (200), at least one of said holding zones (104) of said needle (200) being constituted by two protruding grooves defining a longitudinal guide groove for the ends (201, 202) of said needle (200). Surgical suture system comprising an endoscopic cap (100) and a needle (200) according to claim 1 characterized in that a peripheral groove formed in the tubular wall (103) of said cap (100) constitutes said temporary holding means (105) of the suture thread (210) engaged on said needle (200). Surgical suture system according to claim 1 characterized in that an annular protuberance formed inside said cap (100) and defining a space for guiding said thread (210) constitutes said temporary holding means (105) of a suture thread (210) engaged on said needle (200). Surgical suture system according to claim 1 characterized in that said means for temporarily holding (105) a suture thread (210) engaged on said needle (200) is located in a transverse plane passing through the distal end of said friction zone of said needle (200). Surgical suture system according to claim 1 characterized in that said means for temporarily holding (105) a suture thread (210) engaged on said needle (200) is located in a transverse plane passing through the proximal end of a friction zone of said needle (200). Surgical suture system according to claim 1 characterized in that said temporary holding (105) of a suture thread (210) is achieved by ephemeral bonding. Surgical suture system according to claim 1 characterized in that said cap (100) has an angular location index.

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