FR3138766A1 - Surgical suture system including improved cap - Google Patents

Abstract

The present invention relates to a surgical suture system comprising an endoscopic cap (100), a needle (200) and an endoscopic tool for gripping said needle (300) movable axially relative to said cap (100) characterized in that said needle ( 200) is temporarily retained by means (104) for holding said needle (200) in said cap (100), when said gripping tool (300) is in the rear position in a position suitable for gripping by said gripping means (300), and in that said cap (100) further presents means (105) for holding a suture thread (210) engaged on said needle (200). Abstract Figure: Figure 5

Description

Surgical suture system including improved cap Field of the invention

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

Endoscopic surgery is a method of visual exploration of the interior of a cavity using optical tubular equipment introduced either through the body's natural orifices (flexible endoscopy) or through incisions of a few millimeters in the cavity. skin (laparoscopy). This method allows the insertion and use of instruments within the body in order to carry out surgical operations. This type of minimally invasive surgery offers many advantages over traditional surgical techniques (reduction in post-operative pain, recovery time and complications, etc.).

Numerous miniaturized instruments have thus been proposed for this purpose, and 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 working channel of flexible endoscopes.

In the particular field of endoscopic wound closure, surgeons have various techniques at their disposal. These techniques consist either of placing staples or clips or of performing suturing by remotely activating a needle carrying a suture thread. The present invention belongs to this last family of solutions.

In the field of classic (open) surgery, many developments relate to specific needles with optimized tapered tips with a curved shape allowing more precise rotation and usable with a needle holder in order to easily catch the needle whatever it is. the laterality of the user. With the evolution of practices and the appearance of laparoscopy, the problem of safely introducing the needle into the patient arose. Today, the trocars used to introduce laparoscopic tools have orifices large enough to allow the passage of these standard needles and several technical solutions have been developed in order to bring in and catch the needle easily.

On the other hand, regarding flexible endoscopy the problem remains unsolved. The working channel of the endoscope only has very narrow access, it does not allow the passage of the curved needle inside. Thus, the technical problem is to be able to bring the curved needle outside the flexible endoscope without the walls of the gastrointestinal tract being damaged. The invention relates more particularly to the family of curved needles adapted to new techniques for suturing in flexible endoscopy.

State of the art

We know in the state of the art the Chinese patent applications CN105902286A and CN206063188U describing an endoscopic suturing device having at its distal end a tubular cap in which is engaged a needle made of a shape memory material constituting a staple. This solution is not satisfactory because it requires the use of shape memory alloys having the capacity to keep an initial shape in memory and return to it even after deformation, and the possibility of alternating between two previously memorized shapes when its temperature varies around a critical temperature. In addition, these properties must be combined with the mechanical and biocompatibility properties inherent to a medical device, and moreover present a low cost, in the case of consumables.

Patent application EP2429374 describes a medical device usable with an endoscope for suturing a perforation in a tissue comprising a tip defining an interior space dimensioned to receive a distal end of the endoscope, an elongated side tube defining a side channel, the side tube being folded back to the tip and a needle having a shaft and a needle tip detachably connected to a distal end of the shaft. The needle is sized to be moved in translation through the side channel. A suture is attached to the needle tip and a retrieval device is sized to be translated through a working channel of the endoscope for removal of the suture and needle tip.

Patent EP1839588 describes a surgical suturing device comprising a needle mounted inside the suture housing for movement around a curved trajectory. A drive assembly is operably associated with the needle to control movement of the needle with a suture attached thereto around the trajectory in a manner facilitating application of the suture to the tissue.

Disadvantages of the prior art

The solutions of the prior art present a significant amount of space, 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.

In addition, their use is relatively complex and unusual for the surgeon. First, the suture is done frontal and not tangential as is the case in open or laparoscopic surgery. Second, the needle is not free to move but attached to the endoscope or device. Finally, the solutions of the prior art require great dexterity from the operator to grasp the needle, which is in a position distant from the operator, and then position it and move it to the level of the area to be sutured, and this without obscuring vision or damaging the walls of the gastrointestinal tract.

Solution provided by the invention and general principles

Needles used in open or laparoscopic surgery have already proven their effectiveness and should be able to be used in flexible endoscopy. Unfortunately, the essential problem is linked to the management of the needle which must be able to be brought in, delivered and withdrawn safely despite its large size and its curved shape. The insertion and withdrawal of the needle must not be able to cause damage to the tissues of the digestive tract. Today, there is no satisfactory solution.

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 suture system making it possible to perform suturing in endoscopy, and more particularly in flexible endoscopy, using standard and known tools 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 allowing tangential suturing to be performed using a free needle controllable in different directions of space - translation and rotation.

The aim of the present invention is to propose an endoscopic heading:

a) allowing a large, curved, standard surgical needle to be introduced and withdrawn atraumatically and safely through the gastrointestinal tract,

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

c) not limiting the visibility of the user.

An endoscopic cap is an accessory generally composed of 2 parts:

• A distal part made of hard or flexible transparent plastic in contact with the walls of the digestive tract,
• A proximal part in transparent flexible plastic which allows attachment to the distal end of a flexible endoscope.

This accessory determines the operating field at the end of the endoscope which includes an operating channel allowing the passage of the needle gripping means. It allows the fabric to be vacuumed if necessary and treated with different tools. Generally this type of cap is non-functionalized.

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

Thus, to meet these 3 essential functions the invention relates to a surgical suture system comprising an endoscopic cap, a needle and a means for gripping said needle whose end is movable axially in translation and in rotation relative to said cap ensuring that the needle is maintained in a position allowing it to be grasped by the gripping tool, for example a needle holder, its extraction outside the cap by an axial movement of the gripping means then the manipulation of the extracted needle of the cape, characterized in that:

• said needle is retained in said cap when said gripping tool is in the rear position,
• said needle is held temporarily against two diametrically opposite zones of the interior wall of said endoscopic cap and maintains a constant shape independently of the temperature, unlike a shape memory needle,
• said needle is pushed back by the gripping means when said gripping tool is actuated in a position suitable for gripping the needle,
• said cap further presents a means for holding the suture thread engaged on said needle.

The needle is not flexible or has shape memory but of the “rigid elastic” type, that is to say, made of a material which deforms little and reversibly when subjected to a stress on both arcuate ends of the needle, according to the direction of the needle cord, 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.

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 of temporarily holding the needle which can be formed of one or more grooves inside the cap allowing the needle to be placed and held,
• A means of holding the suture thread connected to the needle which may be formed of one or more grooves inside or outside the cap allowing the thread to be placed, or of a biocompatible glue,
• Custom dimensions adapted to the dimensions of the suture,
• Positioning of the needle in the cap allowing protection of the sharp ends of the needle and easier gripping.

Besides injury to the gastrointestinal wall by the needle during insertion and withdrawal, there is another significant risk with endoscopic suturing which is losing the needle. Indeed, if the free needle were dropped into the stomach or colon, the peristalsis of these organs would make the probability of finding it low. A needle lost in this way presents a serious danger to the patient as it passes through the digestive tract. The fear of losing a needle is one of the reasons why current suture solutions are mostly attached to the endoscope tip. 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 gradual 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 dropping the needle and re-entering it in another way to allow effective suturing without the risk of losing the needle.

The endoscopic cap is designed so that the position of the needle makes it accessible to the endoscopic needle holder, thus allowing 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,

- This endoscopic cap is designed to allow positioning of the needle without significantly hindering visibility.

The invention relates in particular to a surgical suture system comprising an endoscopic cap, a needle and an endoscopic tool for gripping said needle movable axially relative to said cap characterized in that said needle is retained - when said gripping tool is in position rear – by the cooperation of two diametrically opposite zones of said endoscopic cap with the opposite ends of said needle in a position adapted to gripping by said gripping means, and in that said cap further presenting a means for holding a thread suture engaged on said needle.

The gripping tool may for example be an endoscopic needle holder like that of the type described in patent EP3509503.

Preferably, said needle is of arcuate shape.

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

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

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

According to another variant, the tubular part of said cap has two diametrically opposed holding zones.

Advantageously, said housing for holding the suture thread engaged on said needle is constituted by a peripheral groove formed in the wall of said cap.

According to another variant, said housing 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.

Advantageously, said housing 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.

According to a variant, said housing 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.

Advantageously, said heading has an angular location index.

According to an advantageous embodiment, said cap is made up of a single or several functional elements which can be assembled together in order to constitute the invention in its final form.

Detailed description of a non-limiting example of carrying out the invention

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

there represents a front view and a side view of the invention according to a first embodiment comprising a groove and a proximal groove.

there represents a front view and a side view of the invention according to a second embodiment comprising two grooves and a proximal groove.

there represents a front view and a side view of the invention according to a third embodiment comprising two grooves and a distal groove.

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

there represents a set of views describing the 4 stages of the interaction between the invention and the needle gripping means.

Detailed description of a first example of production

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

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

The distal tubular wall (103) has a housing (105) for temporarily holding 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 wire can also be held in place by gluing.

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

The holding means (104) of the surgical needle (200) makes it possible to hold it while protecting the walls of the gastrointestinal tract until it is extracted by the gripping means (300) of the needle. In the exemplary embodiment illustrated by , it is constituted by a single groove (104) extending over the length of the tubular wall (103) of the cap (100), the pointed end (201) of the needle (200) bearing against the wall interior of the tubular part (103) of the cap (100), substantially in a zone diametrically opposite to the single groove (104).

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 alone, simply by of the movement of the distal end of the endoscope (1), but sufficiently low to allow the needle gripping means (300) to push the surgical needle (200) by an axial movement, in order to deliver it.

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

The needle (200) can also have a straight shape, the two ends (201, 202) being engaged in the longitudinal groove(s) (104).

Variants of realization

The holding means (104) of said surgical needle (200) can be produced in shapes other than a single groove (104) extending over the length of the tubular wall (103) of the cap (100).

It can be carried out as illustrated by by two grooves (104) each extending along two diametrically opposite longitudinal generators of the tubular wall (103) of the cap (100).

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) allowing it to be not significantly obstruct the field of view of the camera and thus the visibility of the endoscopist.

The position of said surgical needle (200) provides compatibility with different types of endoscopes (1) available on the market. It is possible to rotate the cap (100) relative to the endoscope (1) at an appropriate angle so that the surgical needle is ideally placed vis-à-vis the operating channel (3) of the endoscope (1). endoscope (1).

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 part of the interior surface of the tubular wall (103) of the distal end of the cap (100).

If the longitudinal groove(s) (104) are arranged over only part of the length of the distal end of the distal tubular part (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).

The longitudinal groove(s) (104) of said surgical needle holding means (200) is/are in relief relative to the walls of the distal tubular wall (103). In a first embodiment, the groove(s) (104) is/are represented by an addition of material relative to the walls (103) of the cap (100). In a second embodiment, the groove(s) (104) is/are formed by a removal of material relative to the walls of the distal tubular part (103).

The longitudinal groove(s) of said holding means (104) of the surgical needle (200) is/are open at their distal end in order to allow the release of said surgical needle (200). into the gastrointestinal tract using the needle gripping means (300). This gripping means passes through the operating 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 letting go.

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 means (300) but also the rehousing of the needle (200). needle (200) in the opposite direction (with the tips of the needle (201, 202) towards the distal end (102) of the cap (100); that is to say towards the lumen of the gastro-tract intestinal). 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.

According to another embodiment, the opening at the distal end of the groove(s) (104) is widened outwards - in the shape of a V - 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.

There illustrates the 4 main stages of interaction of the needle gripping means (300) with the invention. In an initial phase, the endoscope (1) is placed in the patient's digestive system. The endoscopic cap (100) is disposed 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 that the point of inflection (204) of its curvature is arranged towards the distal end (102) of the cap (100), towards the intestinal lumen. This position helps protect the walls of the gastrointestinal tract from possible injuries or perforations that could cause complications for the patient. In addition, this position allows easier gripping of the needle by the use described below. The needle gripping means (300) - eg endoscopic needle holder - is arranged inside the operating channel (3) of the endoscope (1) recessed in a rear position.

In a second phase, the distal end of the needle gripping means (300) - e.g. endoscopic needle holder - arranged inside the operating channel (3) of the endoscope (1) is exposed by a projection axial (translation) at the exit of the working channel (3) at the distal end of the endoscope (1). The needle gripping means (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 outlet of the working channel (3) at the distal end of the endoscope (1) and the curvature of the surgical needle - where the latter is caught. As a result, the gripping means (300) of the surgical needle emerging from the operating channel (3) can protrude by a sufficient length giving it a certain flexibility.

In a third step, this flexibility allows the gripping means (300) of the surgical needle to deform slightly and thus be deflected in contact with the surgical needle (200). The jaws of the surgical needle gripping means are positioned laterally in relation to the needle. The deviation of the means for gripping the surgical needle (300) causing a constraint on the latter, the opening of its jaws allows it to return to the initial position – releasing the constraint – 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 in flexible material allowing the surgical needle (200) to also perform a slight lateral movement facilitating the passage/deflection of the means gripping the needle (300). The needle gripping means (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 means (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 letting go. The needle gripping means (300) being rotatable, the surgical needle (200) is itself progressively and precisely controllable in rotation when it is held by the gripping means (300).

Suture thread housing

The suture thread (210) is maintained in one example by a groove-shaped housing (105) dug into the internal face of the tubular wall (103) of the cap (100) so as not to increase the diameter thereof. this. Indeed, the smaller the diameter, the easier the handling of the invention and its passage through the gastrointestinal tract (particularly in the esophagus).

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

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 on the . It(s) are located in a transverse plane located 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 said surgical needle (200) to be held in place. ) 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.

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

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

In another embodiment illustrated by the , the circular groove(s) (105) is/are represented by a withdrawal of material relative to the walls (103) of the invention forming a narrow slot in the thickness of the wall of the heading (100). This embodiment makes it possible to not reduce the endoscopist's field of vision by not adding additional thickness to that of the tubular wall (103) of the cap (100).

The circular groove(s) (105) for holding the suture thread (210) is/are arranged over the entire circumference of the invention parallel to the walls of the invention in order to allow storage the entire length of the wire without hindering the endoscopist's visibility or the passage of tools.

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

The thread can be held in place by temporary bonding, which does not resist traction exerted by the operator or by friction in the groove.

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 taken out of its holding means (104) by said endoscopic needle holder (300).

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) disposed at its distal end. This plastic button (203) makes it possible to anchor the suture thread (210) at the start of the suture.

Claims (12)

Surgical suture system comprising an endoscopic cap (100), a needle (200) and an endoscopic tool for gripping said needle (300) movable axially relative to said cap (100) characterized in that said needle (200) is temporarily retained by means (104) for holding said needle (200) in said cap (100), when said gripping tool (300) is in the rear position in a position suitable for gripping by said gripping means (300), and in that said cap (100) further presents means (105) for holding 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 for holding (105) a suture thread (210) is formed by a housing. Surgical suture system according to claim 1 characterized in that at least one of said holding zones (104) of said needle (200) is constituted by a longitudinal groove provided on the tubular wall (103) of said endoscopic cap (100) . Surgical suture system according to claim 1 characterized in that at least one of said holding zones (104) of said needle (200) is constituted by two protruding grooves defining a longitudinal guide groove of the ends (201, 202) of said needle (200). 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). Surgical suture system comprising an endoscopic cap (100) and a needle (200) according to claim 1 characterized in that said housing for temporarily holding (105) the suture thread (210) engaged on said needle (200) is constituted by a peripheral groove formed in the tubular wall (103) of said cap (100). Surgical suture system according to claim 1 characterized in that said housing for temporarily holding (105) a suture thread (210) engaged on said needle (200) is constituted by an annular protuberance formed inside said cap (100) and defining a space for guiding said wire (210). Surgical suture system according to claim 1 characterized in that said housing 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 housing 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 said friction zone of said needle (200). Surgical suture system according to claim 1 characterized in that said temporary retention (105) of a suture thread (210) is produced by ephemeral bonding. Surgical suture system according to claim 1 characterized in that said cap (100) has an angular registration index.