UNIVERSAL DEVICE FOR DEPLOYING IMPLANTS OF THE TYPE OF STENTS OR ENDOPROSTHESES

Abstract

The invention relates to a launcher (50) for releasing an expandable implant (20, 30) into an anatomical conduit, comprising a fixed subassembly and a retraction subassembly such as to translate an outer sheath (56) along an internal flexible tubular portion (55), said outer sheath (56) being able to move from a closed position in which it covers an implant (20, 30) to a position in which it releases said implant (20, 30), and a control mechanism for moving the retraction subassembly. According to the invention, the control mechanism comprises a hand handle having a fixed base (60) connected to the fixed subassembly and defining a fixed point, a movable carriage (62) connected to the retraction subassembly, said movable carriage (62) having locking elements for locking the movable carriage (62) in various positions corresponding to stops in the release of the implant (20, 30). Figure for the abstract: [Fig 15]

Description

Title of the invention: UNIVERSAL DEVICE FOR RELEASING IMPLANTS OF THE TYPE OF STENTS OR ENDOPROSTHESES technical field

[0001] The present invention relates to the general technical field of implants or expandable or self-expanding implants. These implants are intended to be placed in any duct of bodily fluid circulation or cavity of a living being. They may be simple implants or connectable implants. The latter is intended to be mechanically linked, once placed in a duct of a bifurcation, to another implant. The implant is therefore called either the mother implant or the branch implant when it connects in situ to the mother implant.

[0002] The invention relates more particularly to the technical field of release devices, also called surgical launchers or simply launchers in the present, allowing the release, deployment and where appropriate the connection of implants between them, in conduits or in anatomical cavities.

[0003] In the present, the term implant should be understood in a broad sense as encompassing all types of expandable implants, expandable or self-expandable prostheses or endoprostheses or those requiring a specific mechanical action enabling the implant to be applied against a wall of an anatomical cavity.

[0004] Connected implants are, for example, placed in a cavity of a living being and more particularly in a circulatory network, especially arterial and venous, in a region where the corresponding vessel has collateral branches or bifurcations requiring the maintenance of their perfusion.

[0005] Interesting applications are found in the venous system, particularly in the inferior vena cava at the level of the iliac bifurcation, at the level of the joining of the renal veins and the superior vena cava or at the level of the joining of its collateral branches.

[0006] In one example of application, the fluid circulation conduit, in this case blood, corresponds to the aorta, in which a first implant, called the mother implant, is positioned, a second implant, called the branch implant, is deployed in an artery branching off the aorta such as the iliac artery, the renal artery, the superior mesenteric artery, the celiac trunk and the supra-aortic arterial trunks, etc.

[0007] In another example, the first implant is intended to be placed in the aortic arch. The second implant is then placed in one of the branches opening into the aortic arch, such as the left common carotid artery, the left subclavian artery or the brachiocephalic trunk.

[0008] The invention also relates to implants intended for use in urology.

[0009] The implant(s) mentioned above are intended to be positioned and deployed in blood circulation conduits in particular to treat areas with defects or diseases such as aneurysms or dissections.

[0010] Implant placement is also used in cases of vascular disease such as obliterative lesions and compressive syndromes.

[0011] The implantations in question are generally performed using endoluminal techniques. These minimally invasive techniques result in less mortality and morbidity for the patient, as well as a reduction in operating time.

[0012] It is evident that the application to a T-shaped implant system is not limiting to the present invention. It also applies to any type of implant whose structure or shape inherently requires proximal-to-distal or distal-to-proximal release.

[0013] The invention relates more generally to a launcher for implants having any singularity, for example a variation in profile, radial force, type of cover, window, structure or other.

[0014] In a conventional application, the user holds the central part of the launcher supporting the implant (fixed point) and slides the outer sheath (retracting movement of the outer sheath). This movement of the outer sheath is typically performed from distal (away from the operator) to proximal (near the operator). The sliding of the outer sheath over the central part in a distal-proximal direction causes the progressive release of the implant from its distal end. State of the art

[0015] Various implant release devices are known, allowing the implant to be gradually released. These known devices are not without drawbacks.

[0016] Launchers equipped with a handle and implementing implant release through automated or semi-automated assistance are known. Such technology is complex to implement and, above all, very expensive.

[0017] Launchers with removable stops of different lengths corresponding to the functional sections of the implants are also known.

[0018] However, the removable stop design has limitations that can lead to a loss of the desired function, namely, ensuring the release steps are carried out in a logical and unfailing order. Indeed, the current design of implant launchers does not allow for the removal of the stops in a predefined order. The user, if not properly trained in the use of the product, or in a situation where the operational exercise does not allow him to pay attention to the order of removal of the stops, he may remove an inappropriate stop.

[0019] The current design, with stops of varying lengths (corresponding to the functional sections of the implants), creates a risk of improper deployment if these stops are not removed in the prescribed order, potentially leading to the unintentional release of the implant. Indeed, believing they are guided by a safety mechanism, the user may, for example, accidentally release the longest stop from the device. An untrained or inattentive user may also remove all the stops before insertion into the patient. If the implants are not equipped with other markers, such as markings or radiopaque markers, the user may no longer be guided in their procedure. It is also important to emphasize that during an implant recapture procedure, the user must replace the stops. During this operation, the risk of mixing them up is increased.

[0020] It is also possible that during the surgical procedure, a person may discard the stops, believing them to be no longer useful, or because they have come into contact with a non-sterile area of ​​the operating room. It is therefore impossible to replace the stops safely during a subsequent attempt to free the implant following its recapture.

[0021] Furthermore, current launchers are each specific in their construction to a particular type of implant. It is therefore necessary to design a launcher dedicated to each type of implant to allow for precise deployment. Thus, a modification to the shape, structure, and / or dimensions of an implant requires the user to use a launcher that has been modified accordingly.

[0022] The present invention also finds its application in the field of endoprostheses covered by a textile or a membrane.

[0023] The present invention finds its application particularly in the field of loading implants / stents comprising a braided and / or twisted and / or laser-cut structure. Description of the invention

[0024] The object of the present invention is to overcome the disadvantages of the prior art and to provide a new release device or launcher, allowing precise release and deployment in an anatomical area while substantially reducing the risks of errors in handling said launcher by the user when releasing an implant.

[0025] Another object of the invention is to provide a new launcher whose design allows for universal use and in particular use without structural modifications or functional, to drop implants of different types and implants of different shapes and / or structures and / or dimensions.

[0026] Another object of the invention aims to provide a launcher whose design allows for the connection of a branch implant to a mother implant to be carried out with high precision and reliability.

[0027] Another object of the invention aims to provide a launcher whose manufacture and use are particularly simple and economical.

[0028] Another object of the invention aims to provide a launcher enabling precise and safe implementation of the different phases of release and possible total or partial recapture of an implant.

[0029] Another object of the invention is to propose a new method of loading a surgical launcher compatible with all types of implants.

[0030] Another object of the invention is to propose a new method for loading implants / stents, which have a braided and / or twisted and / or laser-cut structure.

[0031] The objects assigned to the invention are reached by means of a launcher for releasing an expandable implant into a conduit or anatomical cavity, said implant being loaded into the launcher comprising a fixed sub-assembly and a retraction sub-assembly capable of moving relative to the fixed sub-assembly so as to translate an outer sheath on an internal flexible tubular portion of the fixed sub-assembly, said outer sheath being able to move from a closed position in which it completely covers the implant and maintains the latter in a non-deployed state, to another position in which said implant is released and fully deployed, the outer sheath being integral with the retraction sub-assembly also being able to move in the opposite direction, a control mechanism for moving the retraction sub-assembly relative to the fixed sub-assembly and progressively releasing the implant, characterized in that the control mechanism comprises: - a manual control handle comprising a fixed base of the fixed subassembly and provided with a first gripping and manipulation area defining a fixed point, - a mobile trolley of the removal sub-assembly guided by sliding on the fixed base, said mobile trolley being connected to the external duct and comprising another gripping and handling area, - and locking devices to block the mobile carriage in various positions corresponding to identifiable stable stops, materializing the successive phases of the release and / or recapture of the implant.

[0032] According to one embodiment, the fixed subassembly comprises a through-tube internal flexible element provided with a fixed atraumatic tip at its end distal and an end connector at its proximal end, said internal tubular flexible element being slidably mounted in the internal tubular flexible part and in a rigid cannula attached to the fixed base, the internal tubular flexible part slidably mounted on the internal tubular flexible element being in contact at its proximal end with the rigid cannula and is in contact at its distal end with a retention ring also slidably mounted on the internal tubular flexible element, the mobile carriage being slidably mounted on said rigid cannula.

[0033] According to one embodiment, the launcher comprises a complementary inner tube mounted by sliding on the internal tubular flexible element passing through and clamped between the retention ring and the atraumatic tip, the implant not deployed and loaded in said launcher being positioned on the inner tube and on the retention ring.

[0034] According to one embodiment, the retention ring is provided with at least one radial fin engaged in a mesh at the level of a proximal end part of the implant not deployed and constrained by the external sheath, so as to allow recapture of the partially released implant.

[0035] According to one embodiment, the mobile carriage includes at least one guide pin engaged in a guide groove formed in the fixed base and delimiting the path of said guide pin when the retraction subassembly moves relative to the fixed subassembly.

[0036] According to one embodiment, the locking members include fixed stops arranged in the guide groove, the guide pin coming into contact with a stop on after a release phase.

[0037] According to one embodiment, the mobile carriage includes an actuation zone allowing it to be moved manually and longitudinally on the fixed base by exerting on said mobile carriage a substantially longitudinal force R, the guide pin being movable against a restoring force, in a direction transverse to the direction of longitudinal movement of said mobile carriage, so as to bypass the stops when a force P is applied on the actuation zone in a direction transverse to the direction of longitudinal movement of said mobile carriage, thus allowing to pass from one release phase to the next.

[0038] According to one embodiment, the mobile carriage comprises a flexible arm provided near a free end, with at least one guide pin and the actuation zone.

[0039] According to one embodiment, the guide groove comprises a longitudinal section for each release phase and forms a chicane substantially transverse to the movement of the mobile carriage to materialize an end stop of the release phase, said baffle allowing passage into a subsequent longitudinal section / portion to perform another release phase of the implant.

[0040] According to one embodiment, the fixed base includes a complementary guide groove located below the guide groove, a transition groove allowing the guide pin, once it has reached the end of its travel in the guide groove, to pass through the complementary guide groove and return longitudinally while being guided in said complementary groove in an extreme position corresponding to the closure of the outer sheath on the atraumatic tip.

[0041] According to one embodiment, the additional guide groove is straight and without stops.

[0042] According to one embodiment, the mobile carriage, integral with the external sheath, comprises two shells, the first shell comprising the flexible arm supporting the guide pin, the second shell being fixed to the first shell by forming a guide orifice in which the rigid cannula is engaged to guide said mobile carriage during its sliding relative to the fixed base.

[0043] According to one embodiment, the fixed base has at its proximal end two mounting members which, when assembled, form on the one hand a passage for the rigid cannula whose proximal free end constitutes a support for the end connector fixed to the proximal end of the internal tubular flexible element passing through, the assembled mounting members also form the first gripping and handling area.

[0044] According to one embodiment, the launcher includes a removable stop, mounted by clipping onto the fixed base, to block the retraction subassembly in its travel stroke and thus prevent engagement in the last release phase, which prohibits recapture of the implant.

[0045] The objects assigned to the invention are reached using a launcher loading method as described above, comprising the following steps: - assemble the component parts of the launcher, ensuring in said assembly a longitudinal sliding mechanical clearance between the internal tubular flexible element, the internal tubular flexible section, the retention ring, the rigid cannula and the internal tube, - Engage the deployed implant longitudinally around the retention ring and the internal tube by positioning the proximal end of the implant at the level of the retention ring, - Use crimping tools to constrain the implant in its compressed configuration onto the retention ring and the inner tube, - translate the subassembly comprising the retention ring, the inner tube and the implant compressed within the outer sheath, - exert traction on the internal tubular flexible element passing through to longitudinally support the rigid cannula, the internal tubular part, the retention ring, the internal tube and the atraumatic tip in order to take up the longitudinal mechanical sliding play and bring the distal end of the external sheath onto the atraumatic tip, - attach the internal flexible tubular element passing through to the rigid cannula, and - Position the end connector in contact with the proximal end of the rigid cannula.

[0046] The launcher according to the invention has the advantage of being able to release an implant precisely and safely. The launcher makes it possible to precisely position a branch implant within the connection zone at the level of a diaphragm of a mother implant and to establish the connection only if the position of said branch implant is optimal.

[0047] Another advantage of the launcher according to the invention lies in its ease and safety of use. The launcher allows the operator to precisely control and manage, at all times, using the control handle, the different phases of the implant release.

[0048] The launcher according to the invention providing the user, through its ergonomic manual control handle which is particularly easy to grip and manipulate, with sensory and visual feedback on the progress of the different phases of the implant release.

[0049] The launcher according to the invention is remarkable insofar as it can be used for dropping implants of different types by implementing different drop strokes without structural modifications to said launcher.

[0050] Furthermore, the loading method of the launcher according to the invention is independent of the shape, structure, and dimensions of the implants. The near-universal applicability of the launcher according to the invention thus provides substantial economic benefits.

[0051] Another advantage of the launcher according to the invention lies in the possibility of adapting the shape of the control handle, for example during its manufacture by 3D printing, to the shape and dimensions of the implant to be deployed. The launcher according to the invention can thus be adapted to specific release phases related to the implant and the anatomical environment. Brief description of the figures

[0052] Other advantageous features of the present invention will become more apparent upon reading the following description, made with reference to the accompanying drawings, given by way of non-limiting examples, in which:

[0053] [Fig-1] [Fig. 1] is a representation of an example of an embodiment of a known surgical launcher,

[0054] [Fig. 2a] [Fig. 2b] Figures 2a and 2b are longitudinal profile views of an example of the implementation of a branch implant released by a launcher according to the invention,

[0055] [Fig. 3a] [Fig. 3b] Figures 3a and 3b are longitudinal profile views of an example of the implementation of a mother implant dropped by a launcher according to the invention,

[0056] [Fig.4a] [Fig.4b] [Fig.4c] Figures 4a, 4b and 4c are views respectively of Top, side, and bottom views of an example of an embodiment of a surgical launcher according to the invention,

[0057] [Fig. 5] [Fig. 5] is an exploded and perspective view of an example embodiment of a surgical launcher conforming to the invention,

[0058] [Fig. 6] [Fig. 6] is an exploded and perspective view of a distal part of a example of an embodiment of a surgical launcher according to the invention,

[0059] [Fig.7] [Fig.7] is a longitudinal cross-sectional view of a distal part of a example of an embodiment of a surgical launcher according to the invention,

[0060] [Fig.8a] [Fig.8b] Figures 8a and 8b are profile and side views respectively. perspective of a component part of an example of the realization of the surgical launcher of [Fig.5],

[0061] [Fig.9] [Fig.9] is a partial, enlarged and perspective view of part proximal to an example of an embodiment of a surgical launcher according to the invention,

[0062] [Fig. 10] [Fig. 10] is a profile view of a component of an example embodiment of a surgical launcher according to the invention,

[0063] [Fig. 11] [Fig. 12] Figures 11 and 12 are respectively profile and perspective views of another enlarged detail of an example embodiment of a surgical launcher according to the invention,

[0064] [Fig. 13] [Fig. 14] Figures 13 and 14 are respectively profile and perspective views of another embodiment of a surgical launcher according to the invention,

[0065] [Fig.15] [Fig.16] [Fig.17] [Fig.18] Figures 15, 16, 17 and 18 are views of an example embodiment of a surgical launcher according to the invention, in different implant release positions,

[0066] [Fig. 19] [Fig. 19] is a partial and perspective view of another embodiment of a surgical launcher according to the invention,

[0067] [Fig. 20] [Fig. 20] is a perspective view of a component of the launcher surgical [Fig. 19],

[0068] [Fig. 21] [Fig. 21] is a partial and side view of a surgical launcher according to the invention before being loaded by an implant, and

[0069] [Fig.22] [Fig.23] Figures 22 and 23 schematically illustrate two steps of a method for loading a surgical launcher according to the invention, with an implant. Detailed description of the invention

[0070] Elements that are structurally and functionally identical and present on several distinct figures are assigned the same numeric or alphanumeric reference.

[0071] Figure 1 is a representation of an example embodiment of a known surgical launcher used, for example, in the context of a double implantation. The launcher allows, for example, the release of a mother implant into an anatomical bifurcation. The branch implant is released by a dedicated launcher to be connected to the mother implant.

[0072] The launcher comprises two sub-assemblies 1, 2 capable of sliding relative to each other, namely a retraction sub-assembly 1 and a fixed sub-assembly 2.

[0073] The withdrawal subassembly 1 consists in particular of an outer sheath 3 fixed to a hemostatic device 4 via respective connectors 5 and 6

[0074] The fixed subassembly 2 is constructed around a flexible tubular element capable of bending to allow passage through anatomical tortuosity. An internal longitudinal opening in the flexible tubular element allows the insertion of a surgical guide.

[0075] A rigid metal cannula 7 is mounted and glued onto the tubular flexible element passing through. This cannula is suitable for cooperating with a sealing element of the type gasket forming part of the hemostatic device 4 belonging to the withdrawal sub-assembly 1.

[0076] On the rigid metal cannula 7 is mounted, glued, a connector 8, suitable for co-opting with a syringe, thus enabling preoperative lubrication by the use of a physiological fluid contained in the syringe and injected through the internal longitudinal lumen of the tubular flexible element passing through.

[0077] A flexible tube is mounted on the tubular through-hole element, adapted to co-opt in translation with the outer sheath 3 during implant deployment. This flexible tube 6 is in contact at its proximal end with the rigid cannula 7 and at its distal end with a retention ring. The retention ring is designed to hold the implant in place by compression and friction within the outer sheath 3, preventing its unintentional release during the steps preceding its complete deployment.

[0078] On the tubular flexible element traversing is mounted an atraumatic tip 9 allowing access to the pathological site by percutaneous endovascular crossing.

[0079] To deploy the implant, the user actuates the retraction sub-assembly 1 by pulling the hemostatic device 4 towards him and keeping the fixed sub-assembly 2 fixed by holding the connector 8.

[0080] During the pathology access phase, two removable stops 10 and 11 are stacked longitudinally between the connector 8 and the hemostatic device 4, thus preventing the relative movement of the retraction subset 1 with respect to the fixed subset 2.

[0081] To release the first portion of the implant to be dropped, the user grasps the stop 10 via a corresponding gripper and lifts it in a direction substantially perpendicular to the orientation of the rigid metallic cannula 7.

[0082] The user can then translate the hemostatic subassembly 4 until it contacts the stop 11

[0083] To fully release the implant, the user will remove the stop 11 and then translate the hemostatic subassembly 4 until it contacts the connector 8.

[0084] To allow removal of the launcher without hitting the body of the mother implant, the user will make a movement by sliding the hemostatic device 4 towards the distal part of the launcher, causing the launcher to close on the atraumatic tip 9.

[0085] To ensure extraction of the vascular system and the hemostatic valve from the percutaneous surgical introducer, it is necessary to reposition the stops 10 and 11 on the rigid metal cannula 7. The device is then in the configuration where the stack of the two stops 10 and 11 are placed between the hemostatic device 4 and the connector 8 thus locking the movement of the withdrawal sub-assembly 1 vis-à-vis the fixed sub-assembly 2.

[0086] The operation of a launcher designed to release a branch implant is similar to the operation of the launcher described above. The main differences relate to the number of removable stops and their lengths.

[0087] Figures 2a and 2b are longitudinal profile views of an embodiment of a branch implant 20 deployed by a launcher according to the invention. The branch implant 20 has, at one connection end, once deployed, a connection flower 21 followed by a retaining ridge 22.

[0088] Figures 3a and 3b are longitudinal profile views of an embodiment of a mother implant 30 released by a launcher according to the invention. The mother implant 30, or mother implant, has a first longitudinal portion 31 with a diameter larger than the diameter of a second longitudinal portion 32. For example, at the transition between the two portions 31 and 32, there is a diaphragm 33. This diaphragm is open when the mother implant 30 is fully deployed and allows the connection of the branch implant 20 between the connecting flower 21 and the bead 22.

[0089] Figures 4a, 4b and 4c are top, side and bottom views respectively of an example embodiment of a surgical launcher 50 according to the invention and [Fig.5] is an exploded and perspective view of an example embodiment of said launcher 50.

[0090] The fixed subassembly is constructed around the fixed internal tubular flexible element 51, which is capable of deforming in flexion to allow passage through anatomical tortuosity. The internal longitudinal lumen of the fixed internal tubular flexible element 51 allows the insertion of a surgical guide.

[0091] Figure 5 is an exploded and perspective view of an example embodiment of the launcher 50.

[0092] On the fixed internal tubular flexible element 51, a rigid cannula 52 is mounted and glued. This rigid cannula 52, for example metallic, is suitable for cooperating with a sealing element of the type gasket, forming part of a hemostatic device 53.

[0093] On the rigid cannula 52 is mounted, for example glued, a connector 54, suitable for co-opting with a syringe, thus allowing preoperative lubrication by the use of a physiological fluid contained in the syringe and injected through the internal longitudinal lumen of the fixed internal tubular flexible element 51, useful for the insertion of a surgical guide.

[0094] On the fixed internal tubular flexible element 51 is mounted a flexible tube 55, capable of co-opting in translation with an external sheath 56 during the deployment of the implant 20, 30. This flexible tube 55 is in contact at its proximal end with the rigid cannula 52 and is in contact at its distal end with a retention ring 57.

[0095] This retention ring 57, illustrated in more detail in Figures 6, 7, 8a and 8b, comprises at least one fin 57a, adapted to cooperate with at least one mesh of the implant body 20, 30. According to another example of the configuration, the retention ring 57 comprises at least two fins 57a, arranged substantially symmetrically in the plane perpendicular to the direction of release of the implant. This design arrangement allows for the balanced application of forces to the implant 20, 30.

[0096] According to another embodiment, the retention ring 57 has four fins 57a distributed by homogeneous repetition in revolution around the axis formed by a hollow cylinder 57c formed by the retention ring 57, allowing forces to be distributed over a larger number of meshes.

[0097] The retention ring 57 is useful both for recapture of the branch implant 30, and for maintaining the two mother and branch implants during the procedure until their release point.

[0098] On the fixed internal tubular flexible element 51 is mounted, glued or overmolded an atraumatic tip 58 allowing access to the pathological site by percutaneous endovascular crossing.

[0099] The fixed subassembly comprises the internal tubular flexible element 51, which has an atraumatic tip 58 fixed at its distal end and an end connector 54 at its proximal end. The internal tubular flexible element 51 slides into the internal tubular flexible portion 55 and into a rigid cannula 52 attached to the fixed base 60. The internal tubular flexible portion 55, which slides onto the internal tubular flexible element 51, is in contact at its proximal end with the rigid cannula 52 and at its distal end with the retention ring 57, which is also slides onto the internal tubular flexible element 51.

[0100] The mobile carriage 62 is mounted to slide and guided on the rigid cannula 52.

[0101] The launcher 50 also includes a complementary inner tube 59, mounted by sliding on the internal tubular flexible element 51 passing through and clamped between the retention ring 57 and the atraumatic tip 58. The implant 20, 30, not deployed and loaded in said launcher 50, is advantageously positioned on the internal tube 59 and on the retention ring 57. The external sheath 56 and the internal tube 59 thus radially delimit an annular housing 56a for the implant 20, 30.

[0102] The withdrawal subassembly includes the flexible outer sheath 56, assembled, for example glued onto a connector 53a which is mounted, for example screwed onto the hemostatic device 53.

[0103] Figure 9 is a partial, enlarged, and perspective view of the proximal part of an exemplary embodiment of the launcher 50. The latter includes a control mechanism for moving the retraction subassembly relative to the fixed subassembly. The control mechanism includes a manual control handle having a fixed base 60 of the fixed subassembly, said fixed base 60 being provided with a first gripping and manipulation zone 61 defining a fixed point.

[0104] The rigid cannula 52 is advantageously locked at the level of the first gripping and handling zone 61, thanks to the connector 54 to materialize the fixed point of the launcher 50. By way of example, the fixed base (60) has at its proximal end two fixing members which on the one hand clamp a connector 54 and the rigid cannula 52 and on the other hand constitute the first fixed gripping zone 61.

[0105] The control mechanism also includes a mobile carriage 62 attached to the retraction sub-assembly and guided in sliding motion on the fixed base 60.

[0106] Fig. 10 is a profile view of an enlarged detail of an example embodiment of a launcher 50 and more specifically of the fixed base 60 and figures 11 and 12 are, respectively, profile and perspective views of the mobile carriage 62.

[0107] The mobile carriage 62 advantageously comprises a gripping and handling area 63, preferably ergonomic. The mobile carriage 62 is slidably mounted on the fixed rigid cannula 52, located in the extension of the internal flexible tubular portion 51. The mobile carriage 62 comprises a flexible arm 62a provided, near one free end, with at least one guide pin 62b.

[0108] According to one embodiment, the mobile carriage 62 comprises two shells 62c and 62d enclosing the proximal end of the withdrawal subassembly. A first shell 62c comprises the flexible arm 62a supporting the guide pin 62b, and a second shell 62d is attached to the first shell 62c, defining, once assembled, an internal passage for the rigid cannula 52.

[0109] At least one guide pin 62b is engaged in a guide groove 64 formed in the fixed base 60 and forming the path of said guide pin 62b when the retraction subassembly moves relative to the fixed subassembly. The guide groove 64 comprises a longitudinal section for each phase or release stroke. According to one embodiment, the flexible arm 62a has two opposing guide pins 62b, each of which engages in a guide groove 64 formed in the lateral sides of the fixed base 60.

[0110] The control mechanism also includes locking elements to lock the mobile carriage 62 in various positions corresponding to stable, identifiable stops, materializing the successive phases or strokes of release and / or recapture of the implant 20, 30. The mobile carriage 62 associated with the fixed base 60 and the locking elements then functions in a manner similar to a latch lock.

[0111] The locking members include, for example, fixed stops 65 arranged in the guide groove 64. The guide pin 62b comes into contact with a stop 65 at each end of the travel of the mobile carriage 62 corresponding to the end of each of the phases of the release of the implant 20, 30. A series of reverse stops 66 are encountered by the guide pin 62b moving in a direction opposite F to the release direction R, i.e. during the closing of the launcher 50 after the complete release of the implant 20, 30. These reverse stops 66 allow, for example, precise control of the recapture phases of an implant 20, 30 not yet completely released and deployed.

[0112] According to one embodiment, the guide groove 64 has a series of baffles 66 substantially transverse to the movement of the mobile carriage 62, to form the various stops 65, 66 at the end of the release phases. The baffle forces the guide pin 62b, after contact with a stop 65, to be constrained by the manipulator to move into a subsequent longitudinal section of the guide groove 64 to perform another phase or release stroke of the implant 20,30.

[0113] The number of baffles, release strokes and the lengths of the different release strokes depend on the shape and dimensions of implant 20, 30 and the different phases of positioning and / or release which are necessary to obtain an optimal and localized and precise deployment of implant 20, 30.

[0114] The mobile trolley 62 includes another gripping and actuation zone 63, which allows it to be moved manually and longitudinally on the fixed base 60 by exerting on said mobile trolley 62, a substantially longitudinal force.

[0115] The guide pin 62b is movable against a restoring force, thanks to the flexible arm 62a, in a direction transverse to the direction of longitudinal movement of said mobile carriage 62.

[0116] The transverse movement of the guide pin 62b allows the stops 65 to be retracted. When a force is applied along a direction P transverse to the longitudinal direction of movement on the flexible arm 62a, the movable carriage 62 can move from one release stroke to the next. The actuation zone of the movable carriage 62 is advantageously located on the flexible arm 62a.

[0117] According to another embodiment, illustrated in figures 13 and 14, the fixed base 60 includes a complementary guide groove 67 located under the guide groove 64, a transition groove 68 allowing the guide pin 62b, once it has reached the end of its travel in the direction R (retraction) in the guide groove 64, to pass through the complementary guide groove 67 and return longitudinally, in the direction F (closure) being guided in said complementary groove 67 in an extreme position corresponding to the closure of the outer sheath 56 on an atraumatic point 58.

[0118] The additional guide groove 67 is advantageously straight and without stops.

[0119] When releasing different implants 20, 30, the same launcher 50 can be used. Depending on the implant 20, 30 in question, the user can pass through different stops 65 which have no functional impact on the deployment of said implant 20, 30. For example, the mother implant 30 can be released with fewer functional stops 65 than the number of functional stops 65 required for the complete deployment of a flower, a bead, and the body of the branch implant 20.

[0120] The first gripping and handling zone 61 includes, for example, two parts 61a and 61b assembled by means of screws 70 and the two shells 62c and 62d are, for example, assembled by means of screws 71.

[0121] Figures 15, 16, 17 and 18 are views of the launcher 50 with different positions of the mobile carriage, each corresponding to a specific phase of the release of an implant not shown.

[0122] Thus, in [Fig. 15], the mobile carriage 62 is in contact with a stop 65 after a first sliding stroke on the fixed base 60, corresponding to the execution of a first phase of the release of a branch implant 20. This phase corresponds for example to the deployment of the hook flower 21 of said branch implant 20.

[0123] With pressure applied to the flexible arm 62a in direction P, the guide pin 62b disengages from the stop 65 and passes through the baffle formed by the guide groove 64 to move longitudinally within said guide groove 64 before being blocked by another stop 65 after a second sliding stroke. This sliding stroke corresponds to a further retraction of the outer sheath 56 and, for example, to a deployment of the rim 22 of the implant branch 2O. This phase of the release is illustrated in [Fig. 16].

[0124] Figure 17 illustrates the subsequent release phase, with an additional retraction of the outer sheath 56, allowing a large portion of the implant branch 20 body to be deployed while retaining the possibility of recapture. Indeed, the proximal end portion of the implant branch 20 remains constrained against the retention ring 57 by the outer sheath 56.

[0125] Fig. 18 illustrates the launcher 50 with the flexible arm 62a in extreme stop on the fixed base 60, at the end of the last release stroke, corresponding to the maximum retraction of the outer sheath 56 and the complete deployment of the implant branch 20. The latter is then no longer in contact with the retention ring 57 and no recapture is possible.

[0126] Fig. 19 is a partial and perspective view of another embodiment of the surgical launcher 50. The launcher 50 includes a removable stop 70, mounted by clipping onto the fixed base 60, intended to block the retraction subassembly in its travel and thus prevent engagement in the final release phase, which phase prevents recapture of the implant 20, 30.

[0127] Figure 20 is a perspective view of an example embodiment of the removable stop 70. The latter is advantageously symmetrical and flexible and includes handling flaps 70a. The removable stop 70 also includes lugs 70b, 70c, 70d or other bosses that engage with the fixed base 60, for example in the guide grooves 64. The user can thus, by slightly deforming the removable stop 70 via a handling flap 70a, separate said removable stop 70 from the fixed base 60. The removable stop 70 prevents, as long as it is in place on the fixed base 60, the initiation of the final release stroke of the implant 20, 30, which, once started, no longer allows the implant 20, 30 to be recaptured.

[0128] Fig. 21 is a partial and side view of the launcher 50 before it is loaded by an implant.

[0129] Figures 22 and 23 schematically illustrate two steps of a loading process for a launcher 50, with an implant 20.

[0130] According to an example of implementation, the method of loading the launcher 50 comprises a succession of steps presented below.

[0131] According to one step, the constituent parts of the launcher 50 are assembled by providing a mechanical longitudinal sliding clearance between the internal tubular flexible element passing through 51, the internal tubular flexible part 55, the retention ring 57, the rigid cannula 52 and the internal tube 59.

[0132] Next, according to one step, the implant 20 deployed around the retention ring 57 and the internal tube 59 is engaged longitudinally by positioning the proximal end of the implant 20 at the level of the retention ring 57.

[0133] Next, crimping tools 80 are used to constrain the implant 20 in its compressed configuration onto the retention ring 57 and the inner tube 59. The crimping tools 80 allow, for example, the implementation of a segmental compression technique. The crimping tools 80 are, for example, integrated into a manual or automated machine.

[0134] Next, the subassembly comprising the retention ring 57, the inner tube 59 and the compressed implant 20 is translated into the outer sheath 56.

[0135] Next, traction is applied to the internal tubular flexible element passing through 51 to bring the rigid cannula 52, the internal tubular part 55, the retention ring 57, the internal tube 59 and the atraumatic tip 58 into longitudinal support in order to take up the longitudinal mechanical sliding play and bring the distal end of the external sheath 56 onto the atraumatic tip 58.

[0136] The internal tubular flexible element 51 passing through is made integral with the fixed rigid cannula 52, for example by gluing.

[0137] Then the end connector 54 is fixed onto the rigid cannula 52.

[0138] According to another embodiment, traction is applied to the portion of the internal tubular flexible element 51 passing through the rigid cannula 52, the end connector is engaged on said internal tubular flexible element 51 and when it is in contact with the rigid cannula 52, said end connector 52 is secured to the internal tubular flexible element 51.

[0139] Obviously, the invention is not limited to the preferred embodiment or implementation described above and shown in the various figures, as a person skilled in the art can make many modifications and imagine other variants without going out of the scope of the invention.

[0140] Thus, a technical feature can be replaced by an equivalent technical feature, without departing from the scope of the present invention and and a step in the implementation of the process, can be replaced by an equivalent step, without departing from the scope of the present invention.

Claims

1.

2. Demands Launcher (50) for releasing an expandable implant (20, 30) into a conduit or anatomical cavity, said implant (20, 30) being loaded into the launcher (50) comprising a fixed sub-assembly and a retraction sub-assembly capable of moving relative to the fixed sub-assembly so as to translate an outer sheath (56) on an internal flexible tubular portion (55) of the fixed sub-assembly, said outer sheath (56) being able to move from a closed position in which it completely covers the implant (20, 30) and maintains the latter in a non-deployed state, to another position in which said implant (20, 30) is released and fully deployed, the outer sheath (56) integral with the retraction sub-assembly also being able to move in the opposite direction, a control mechanism for moving the retraction sub-assembly relative to the fixed sub-assembly and progressively releasing the implant (20, 30),characterized in that the control mechanism comprises: - a manual control handle having a fixed base (60) of the fixed subassembly and provided with a first gripping and manipulation zone (61) defining a fixed point, - a movable carriage (62) of the retraction subassembly guided by sliding on the fixed base (60), said movable carriage (62) being connected to the external sheath (56) and having another gripping and manipulation zone (63), - and locking elements for locking the movable carriage (62) in various positions corresponding to identifiable stable stops, materializing the successive phases of the release and / or recapture of the implant (20, 30). Launcher (50) according to claim 1, characterized in that the fixed subassembly comprises a through-tube internal flexible element (51) provided with a fixed atraumatic tip (58) at its distal end and an end connector (54) at its proximal end, said through-tube internal flexible element (51) being slidably mounted in the through-tube internal flexible portion (55) and in a rigid cannula (52) integral with the fixed base (60), the through-tube internal flexible portion (55) slidably mounted on the through-tube internal flexible element (51) being in contact at its proximal end with the rigid cannula (52) and is in contact at its distal end with a retention ring (57) also mounted by sliding on the internal tubular flexible element passing through (51), the mobile carriage (62) being mounted by sliding on said rigid cannula (52).

3. Launcher (50) according to claim 2, characterized in that it comprises a complementary inner tube (59) mounted by sliding on the internal tubular flexible element passing through (51) and clamped between the retention ring (57) and the atraumatic tip (58), the implant (20, 30) not deployed and loaded in said launcher (50) being positioned on the inner tube (59) and on the retention ring (57).

4. Launcher (50) according to claim 2 or 3, characterized in that the retention ring (57) is provided with at least one radial fin (57a) engaged in a mesh at the level of a proximal end portion of the implant (20, 30) not deployed and constrained by the outer sheath (56), so as to allow recapture of the partially released implant (20, 30).

5. Launcher (50) according to any one of claims 2 to 4, characterized in that the movable carriage (62) comprises at least one guide pin (62b) engaged in a guide groove (64) formed in the fixed base (60) and delimiting the path of said guide pin (62b) when the retraction subassembly moves relative to the fixed subassembly.

6. Launcher (50) according to claim 5, characterized in that the locking members comprise fixed stops (65, 66) disposed in the guide groove (64), the guide pin (62b) coming into contact with a stop (65) at the end of a release phase.

7. Launcher (50) according to claim 6, characterized in that the mobile carriage (62) has an actuation zone allowing it to be moved manually and longitudinally on the fixed base (60) by exerting on said mobile carriage (62) a substantially longitudinal force R, the guide pin (62b) being movable against a restoring force, in a direction transverse to the longitudinal direction of said mobile carriage (62), so as to bypass the stops (65, 66) when a force P is applied on the actuation zone in a direction transverse to the longitudinal direction of said mobile carriage (62), thus allowing to pass from one release phase to the next.

8. Launcher (50) according to any one of claims 5 to 7, characterized in that the movable carriage (62) comprises a flexible arm (62a) provided in the vicinity of a free end, with at least one guide pin (62b) and the actuation zone.

9. Launcher (50) according to any one of claims 5 to 8, characterized in that the guide groove (64) comprises a longitudinal section for each release phase and forms a chicane substantially transverse to the movement of the mobile carriage (62) to materialize a stop (65) at the end of the release phase, said chicane allowing passage into a subsequent longitudinal section / portion to carry out another release phase of the implant (20, 30).

10. Launcher (50) according to any one of claims 5 to 9, characterized in that the fixed base (60) comprises a complementary guide groove (67) located below the guide groove (64), a transition groove (68) allowing the guide pin (62b), once it has reached the end of its travel in the guide groove (64), to pass through the complementary guide groove (67) and return longitudinally while being guided in said complementary groove (67) in an extreme position corresponding to the closure of the outer sheath (56) on the atraumatic tip (58).

11. Launcher (50) according to claim 10, characterized in that the complementary guide groove (67) is straight and devoid of stops.

12. Launcher (50) according to claim 8, characterized in that the mobile carriage (62), integral with the outer sheath (56), comprises two shells (62c, 62d), the first shell (62c) comprising the flexible arm (62a) supporting the guide pin (62b), the second shell (62d) being fixed to the first shell (62c) by forming a guide orifice in which the rigid cannula (52) is engaged to guide said mobile carriage (62) during its sliding relative to the fixed base (60).

13. Launcher (50) according to any one of claims 2 to 9, characterized in that the fixed base (60) has at its proximal end two mounting members which, when assembled, form on the one hand a passage for the rigid cannula (52) whose proximal free end constitutes a support for the end connector (54) fixed to the proximal end of the internal tubular flexible element passing through (51), the assembled mounting members also forming the first gripping and handling zone (61).

14. Launcher (50) according to any one of claims 1 to 12, characterized in that it comprises a removable stop (70), mounted by clipping onto the fixed base (60), to block the retraction subassembly in its travel stroke and thus prevent engagement in the last release phase, which prohibits recapture of the implant (20, 30).

15. A method for loading a launcher (50) according to any one of claims 3 to 14, comprising the steps: - assembling the constituent parts of the launcher (50) while providing said assembly with longitudinal sliding mechanical clearance between the internal tubular flexible element (51), the internal tubular flexible part (55), the retention ring (57), the rigid cannula (52), and the internal tube (59), - longitudinally engaging the implant (20, 30) deployed around the retention ring (57) and the internal tube (59) by positioning the proximal end of the implant (20, 30) at the level of the retention ring (57), - using crimping tools to constrain the implant (20, 30) in its compressed configuration onto the retention ring (57) and the internal tube (59), - translating the subassembly comprising the retention ring (57) and the internal tube (59) and the implant (20, 30) compressed in the outer sheath (56),- to apply traction to the internal tubular flexible element (51) to longitudinally support the rigid cannula (52), the internal tubular portion (55), the retention ring (57), the internal tube (59), and the atraumatic tip (58) in order to take up the longitudinal mechanical sliding play and bring the distal end of the external sheath (56) onto the atraumatic tip (58), - to fix the internal tubular flexible element (51) to the rigid cannula (52), and, - position the end connector (54) resting on the proximal end of the rigid cannula (52).

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